tm2035121-5_drsa - block - 2.0469005s
As confidentially submitted to the Securities and Exchange Commission on March 10, 2021 as Amendment No. 2 to the draft registration statement submitted on December 23, 2020.
This Amendment No. 2 has not been publicly filed with the Securities and Exchange Commission and all information herein remains confidential.
Registration No. 333-    
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
VACCITECH LIMITED*
(Exact name of registrant as specified in its charter)
England and Wales
(State or other jurisdiction of
incorporation or organization)
2834
(Primary Standard Industrial
Classification Code Number)
Not Applicable
(I.R.S. Employer
Identification Number)
Vaccitech Limited
The Schrödinger Building
Heatley Road
The Oxford Science Park
Oxford OX4 4GE
United Kingdom
+44 (0) 1865 818 808
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies of all communications, including communications sent to agent for service, should be sent to:
Robert E. Puopolo
Marishka DeToy
Goodwin Procter LLP
100 Northern Avenue
Boston, MA 02210
United States of America
+1 (617) 570-1000
Andrew Harrow
Goodwin Procter (UK) LLP
100 Cheapside
London EC2V 6DY
United Kingdom
+44 (0) 20 7447 4200
Richard D. Truesdell, Jr.
Marcel R. Fausten
Davis Polk & Wardwell LLP
450 Lexington Avenue
New York, NY 10017
United States of America
+1 (212) 450-4000
Simon Witty
Davis Polk & Wardwell
London LLP
5 Aldermanbury Square
London EC2V 7HR
United Kingdom
+44 (0) 20 7418 1300
Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended, check the following box. ☐
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer   ☐ Accelerated filer   ☐ Non-accelerated filer   ☒
Smaller reporting company   ☒
Emerging growth company   ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
CALCULATION OF REGISTRATION FEE
Title of each class of
securities to be registered
Proposed maximum
aggregate offering
price(1)
Amount of
registration fee(2)
Ordinary shares, nominal value £0.01 per share(3)
$      $     
(1)
Estimated solely for the purpose of computing the amount of the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended. Includes the aggregate offering price of additional ordinary shares represented by American Depositary Shares, or ADSs, that the underwriters have the option to purchase.
(2)
Calculated pursuant to Rule 457(o) under the Securities Act of 1933, as amended, based on an estimate of the proposed maximum aggregate offering price.
(3)
These ordinary shares are represented by ADSs, each of which represents      ordinary shares of the registrant. ADSs issuable upon deposit of the ordinary shares registered hereby are being registered pursuant to a separate registration statement on Form F-6 (File No. 333-     ).
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
*
Prior to completion of this offering, we intend to affect a corporate reorganization whereby shareholders of Vaccitech Limited will exchange their shares for those of a newly-created private limited company. We then intend to alter the legal status of the newly-created entity under the laws of England and Wales, or English law, from a private limited company by re-registering as a public limited company and changing the name to Vaccitech plc prior to completion of this offering.

Explanatory Note
This Amendment No. 2 ("Amendment No. 2") to the Draft Registration Statement ("Draft Registration Statement") is being filed solely for the purpose of filing Exhibits 10.3, 10.4, 10.5, 10.6, 10.7 and 10.8. This Amendment No. 2 does not modify any provisions of the prospectus that forms a part of the Draft Registration Statement and accordingly, such prospectus has been omitted.

PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution.
Set forth below is an itemization of the total expenses, excluding the underwriting discounts and commissions, which are expected to be incurred in connection with the sale of ADSs in this offering. With the exception of the registration fee payable to the Securities and Exchange Commission, The Nasdaq Global Market initial listing fee and the filing fee payable to FINRA, all amounts are estimates.
Amount
SEC registration fee
$      *
FINRA filing fee
*
Nasdaq Global Market initial listing fee
*
Printing expenses
*
Legal fees and expenses
*
Accountants’ fees and expenses
*
Blue Sky fees and expenses (including legal fees)
*
Transfer agent and registrar fees and expenses
*
Miscellaneous
*
Total
$ *
*
To be provided by amendment.
Item 14. Indemnification of Directors and Officers.
Subject to the Companies Act 2006, members of the registrant’s board of directors and its officers (excluding auditors) have the benefit of the following indemnification provisions in our articles of association, or the Articles:
Current and former members of the registrant’s board of directors or officers shall be:
(i)   indemnified against any loss or liability which has been or may be incurred by them in connection with their duties or powers in relation to the company, any associated company (as defined in the Articles) or any pension fund or employees’ share scheme of the company or associated company and in relation to the company’s (or associated company’s) activities as trustee of an occupational pension scheme, including any liability incurred in defending any civil or criminal proceedings in which judgment is given in his or her favor or in which he or she is acquitted or the proceedings are otherwise disposed of without any finding or admission of any material breach of duty on his or her part or in connection with any application in which the court grants him or her, in his or her capacity as a relevant officer, relief from liability for negligence, default, breach of duty or breach of trust in relation to the company’s (or associated company’s) affairs; and
(ii)   provided with funds to meet expenses incurred or to be incurred in defending any criminal or civil proceedings or application referred to above.
In the case of current or former members of the registrant’s board of directors, in compliance with the Companies Act 2006, there shall be no entitlement to reimbursement as referred to above for (i) any liability incurred to the registrant or any associated company, (ii) the payment of a fine imposed in any criminal proceeding or a penalty imposed by a regulatory authority for non-compliance with any requirement of a regulatory nature, (iii) the defense of any criminal proceeding if the director is convicted, (iv) the defense of any civil proceeding brought by the registrant or an associated company in which judgment is given against the director, and (v) any application for relief under the statutes of the UK and any other statutes that concern and affect the registrant as a company in which the court refuses to grant relief to the director.
II-1

In addition, members of the registrant’s board of directors and its officers who have received payment from the registrant under these indemnification provisions must repay the amount they received in accordance with the Companies Act 2006 or in any other circumstances that the registrant may prescribe or where the registrant has reserved the right to require repayment.
The board of directors may decide to purchase and maintain insurance, at the expense of the company, for the benefit of any relevant officer in respect of any relevant loss.
The underwriting agreement the registrant will enter into in connection with the offering of ADSs being registered hereby provides that the underwriters will indemnify, under certain conditions, the registrant’s board of directors and its officers against certain liabilities arising in connection with this offering.
Item 15. Recent Sales of Unregistered Securities.
In the three years preceding the filing of this registration statement, we have issued the following securities that were not registered under the Securities Act:
(a)
Issuances of Share Capital
In November 2017, five accredited investors purchased an aggregate of 13,790 shares our Series A preferred stock for approximately £14,999,781.15 at £1,087.65 per share.
In February 2018, one accredited investor purchased an aggregate of 4,597 shares of our Series A preferred stock for approximately £4,999,927.05 at £1,087.65 per share.
In December 2018, two accredited investors purchased an aggregate of 3,678 shares of our Series A preferred stock for approximately £6,000,583.44 at £1,631.48 per share.
No underwriters were involved in the foregoing sales of securities. The sales of securities described above were deemed to be exempt from registration pursuant to either (i) Section 4(a)(2) of the Securities Act, as transactions by an issuer not involving a public offering or (ii) Regulation S promulgated under the Securities Act in that the offers, sales and issuances were not made to persons in the United States and no directed selling efforts were made in the United States.
(b)
Grants and Exercises of Options and Restricted Share Awards
Through January 29, 2021, we have granted stock options to purchase an aggregate of 2,059 shares of our common stock, net of forfeitures, with an exercise price of £0.10 per share, to certain employees, directors and consultants pursuant to the EMI Share Option Scheme. Through January 29, 2021, 662 shares of common stock have been issued upon the exercise of stock options pursuant to the EMI Share Option Scheme.
The issuances of the securities described above were deemed to be exempt from registration pursuant to Section 4(a)(2) of the Securities Act or Rule 701 promulgated under the Securities Act as transactions pursuant to compensatory benefit plans. The ordinary shares issued upon the exercise of options are deemed to be restricted securities for purposes of the Securities Act.
Item 16. Exhibits and Financial Statement Schedules
(a)
Exhibits
Exhibits
number
Description of exhibit
1.1* Form of Underwriting Agreement.
3.1** Articles of Association of Vaccitech Limited, as currently in effect.
3.2* Form of Articles of Association of the registrant (to be effective upon the consummation of this offering).
4.1* Form of Deposit Agreement.
4.2* Form of American Depositary Receipt (included in Exhibit 4.1).
5.1* Opinion of Goodwin Procter (UK) LLP, counsel to the registrant.
II-2

Exhibits
number
Description of exhibit
10.1*# EMI Option Scheme and form of award agreement thereunder.
10.2*# 2021 Stock Option and Incentive Plan and forms of award agreements thereunder (to be adopted prior to the effectiveness of this registration statement).
10.3† License of Technology by and between the Registrant and Oxford University Innovation Limited, dated as of March 4, 2016, as amended on January 14, 2019 and as further amended April 29, 2020.
10.4† License Agreement by and between the Registrant and Oxford University Innovation Limited, dated as of September 8, 2017.
10.5† Master Collaboration Agreement by and between the Registrant and CanSino Biologics, Inc., dated as of September 4, 2018.
10.6† License Agreement by and among the Registrant, The Chancellor, Masters and Scholars of the University of Oxford and Oxford University Innovation Limited, dated as of September 27, 2018.
10.7† License Agreement by and between the Registrant and Vaccitech Oncology Limited, dated as of November 14, 2018.
10.8† Clinical Trial and Option Agreement by and among Vaccitech Oncology Limited, Cancer Research Technology Limited, and Cancer Research UK, dated as of December 16, 2019.
10.9*# Form of Deed of Indemnity between the registrant and each of its directors and officers.
10.10*# Employment Agreement between the Registrant and William Enright, to be in effect upon the closing of this offering.
10.11*# Employment Agreement between the Registrant and Georgy Egorov to be in effect upon the closing of this offering.
10.12*# Employment Agreement between the Registrant and Thomas G. Evans, MD, to be in effect upon the closing of this offering.
10.13*# Employment Agreement between the Registrant and Margaret Marshall, MD, to be in effect upon the closing of this offering.
10.14*# Employment Agreement between the Registrant and Chris Ellis, to be in effect upon the closing of this offering.
10.15*# Employment Agreement between the Registrant and Graham Griffiths, to be in effect upon the closing of this offering.
10.16* Lease Agreement by and between the Registrant and Oxford Sciences Innovation plc, dated March 27, 2019.
21.1** Subsidiaries of the Registrant.
23.1* Consent of BDO LLP, independent registered public accounting firm.
23.2* Consent of Goodwin Procter (UK) LLP, counsel to the registrant (included in Exhibit 5.1).
24.1* Power of Attorney (included on signature page to this registration statement).

Certain portions of this exhibit will be omitted because they are not material and would likely cause competitive harm to the registrant if disclosed.
*
To be submitted by amendment.
**
Previously filed.
#
Indicates a management contract or any compensatory plan, contract or arrangement.
(b)
Financial Statement Schedules
None. All schedules have been omitted because the information required to be set forth therein is not applicable or has been included in the audited consolidated financial statements and notes thereto.
II-3

Item 17. Undertakings.
The undersigned registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreements, certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the provisions described in Item 6 hereof, or otherwise, the registrant has been advised that in the opinion of the U.S. Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
The undersigned registrant hereby undertakes that:
(i)
For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.
(ii)
For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
II-4

SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant has duly caused this registration statement on Form S-1 to be signed on its behalf by the undersigned, thereunto duly authorized, under the laws and regulations of England and Wales, on                 , 2021.
VACCITECH LIMITED
By:
William Enright
Chief Executive Officer
KNOW ALL BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints William Enright and Georgy Egorov, and each of them, his or her true and lawful agent, proxy and attorney-in-fact, with full power of substitution and resubstitution, for and in his or her name, place and stead, in any and all capacities, to (i) act on, sign and file with the Securities and Exchange Commission any and all amendments (including post-effective amendments) to this Registration Statement together with all schedules and exhibits thereto and any subsequent registration statement filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, together with all schedules and exhibits thereto, (ii) act on, sign and file such certificates, instruments, agreements and other documents as may be necessary or appropriate in connection therewith, (iii) act on and file any supplement to any prospectus included in this Registration Statement or any such amendment or any subsequent registration statement filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, and (iv) take any and all actions which may be necessary or appropriate to be done, as fully for all intents and purposes as he or she might or could do in person, hereby approving, ratifying and confirming all that such agent, proxy and attorney-in-fact or any of his or her substitutes may lawfully do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Act of 1933, as amended, this registration statement has been signed by the following persons in the capacities indicated on the      day of           , 2021.
NAME
TITLE
William Enright
Chief Executive Officer and Director
(Principal Executive Officer)
Georgy Egorov
Chief Financial Officer
(Principal Financial and Accounting Officer)
Robin Wright
Chairman and Director
Thomas G. Evans
Director
Alex Hammacher
Director
Pierre A. Morgon
Director

Anne M. Phillips
Director

NAME
TITLE

Karen T. Dawes
Director
By:
Name: William Enright
Title: Chief Executive Officer
Authorized Representative in the United States

 

Exhibit 10.3

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.

 

 DATED    2016 

 

(1)       ISIS INNOVATION LIMITED

 

and

 

(2)       VACCITECH LIMITED

 

LICENCE OF TECHNOLOGY
(ISIS PROJECT Nos. [***])

 

 

 

 

THIS AGREEMENT is made on                                                                                 2016

 

BETWEEN:

 

(1)ISIS INNOVATION LIMITED (Company No. 2199542) whose registered office is at University Offices, Wellington Square, Oxford OX1 2JD, England ("Isis"); and

 

(2)VACCITECH LIMITED (Company No. 9973585) whose registered office is at The Weston Library, Broad Street, Oxford, Oxfordshire, OX1 3BG (the "Licensee").

 

BACKGROUND:

 

(A)The Licensed Technology is connected with Isis Projects [***] 'Adenovirus long promoter', [***] 'Universal influenza vaccine', [***] 'Poxvirus expression system', [***] 'Adenovirus vaccine vectors' ('ChAdOx1' & 'ChAdOx2') and Isis clinical data projects [***] 'Phase I MVA NP+M1', [***] 'MVA-NP+M1 Phase Ila challenge study', [***] 'MVA-NP+M1 Phase I in adults over 50', [***] 'MVA NP+M1 plus TIV Phase I', [***] 'ChAdOx1-NP+Ml Phase I' & [***] 'Phase I ChAdOx1 NP+M1 and MVA NP+M1 in heterologous prime-boost'.

 

(B)The Licensee wishes to acquire a licence to the Licensed Technology in order to develop products in the area of influenza vaccines, cancer vaccines, varicella zoster vaccines and Middle East Respiratory Syndrome ("MERS") vaccines and Isis is willing to license the Licensed Technology to the Licensee, on the terms of this agreement.

 

AGREEMENT:

 

1.Interpretation

 

In this agreement (including its Schedules), any reference to a "clause" or "Schedule" is a reference to a clause of this agreement or a schedule to this agreement, as the case may be. Words and expressions used in this agreement have the meaning set out in Schedule 1.

 

2.Grant of Licence

 

2.1In consideration of the payments required to be made under this agreement by the Licensee, Isis grants to the Licensee a licence in the Territory in respect of the Licensed Technology to develop, make, have made, use and have used and Market the Licensed Product subject to the terms and conditions of this agreement. Subject to clause 5, the Licence in respect of:

 

2.1.1the Licensed Intellectual Property is :

 

(a)in relation to Applications 1 and 2 (i) exclusive in the Field and (ii) non-exclusive in all other fields excluding veterinary applications (apart from MERS);

 

(b)in relation to Application 3 exclusive in all fields excluding veterinary applications;

 

(c)in relation to use of ChAdOx1 vector under Application 4 (i) exclusive in the Field and (ii) non-exclusive in all other fields excluding veterinary applications (apart from MERS) and the ChAdOx1 Excluded Fields provided that in the event that the Licensee fails to meet its diligence obligations under clause 10, as determined in accordance with this agreement, with regard to:

 

(i)vaccines for MERS, including but not limited to the initiation of manufacture of GMP grade vaccine for MERS by 31 December 2016, the licence in respect of vaccine for MERS only will automatically become non-exclusive in all fields excluding the ChAdOx1 Excluded Fields; and

 

(ii)vaccines for varicella zoster, including but not limited to the initiation of manufacture of GMP grade vaccine for varicella zoster by 1 September 2017 (or 1 March 2017 where grant funding has been raised for the Licensee to manufacture GMP grade vaccine for MERS), the licence in respect of vaccines for varicella zoster only will automatically become non-exclusive in all fields excluding the ChAdOx1 Excluded Fields and further, if by 1 September 2018, the Licensee has not initiated manufacture of GMP grade vaccine for varicella zoster that non-exclusive licence in respect of vaccines for varicella zoster will terminate;

 

1

 

 

(d)in relation to use of the ChAdOx2 vector under Application 4 non-exclusive in all fields with the exclusion of all veterinary applications (apart from MERS) and the ChAdOx2 Excluded Fields.

 

2.1.2the Clinical Data is exclusive in the Field; and

 

2.1.3the Licensed Know-how is exclusive in the Field except in respect of Licensed Know-how relating to the ChAdOx2 Vector which is non-exclusive.

 

2.2Except in respect of the ChAdOx2 Vector and in respect of the ChAdOx1 Vector with regard to vaccines for MERS and varicella zoster where the Licensee fails to meet its diligence obligations under clause 10, as determined in accordance with this agreement (including, without limitation, clause 2.1.1(c)), Isis will not grant a licence in the Field to any third parties with respect to the Licensed Know-how.

 

2.3The Licensee may grant sub-licences with the prior written consent of Isis, such consent not to be unreasonably withheld, conditioned or delayed, provided that:

 

(a)the sub-licensee has obligations to the Licensee commensurate with those which the Licensee has to Isis under this agreement, except the financial terms hereof or where it is not legally possible to include such obligations in the sub-licence;

 

(b)the nature of the proposed sub-licensee is not likely in Isis's reasonable opinion to have any detrimental impact on the reputation of either Isis or of the University;

 

(c)the sub-licensee has sufficient financial resources to develop and Market the Licensed Product (it being acknowledged and agreed that if the sub-licensee is a publicly-listed company with a market capitalisation equal to or in excess of [***] it will be considered to have sufficient financial resources to develop and Market the Licensed Product);

 

(d)as soon as reasonably practicable following the grant of each sub-licence, the Licensee provides a certified copy of that sub-licence to Isis;

 

(e)the sub-licensee enters into a Deed of Covenant with the Licensor in the form set out in Schedule 4;

 

(f)Isis will be deemed to have consented to a sub-licence within [***]of receipt of such written request by the Licensee to grant a sub-licence, provided it has not refused consent or requested reasonable further time or information to consider the request within such [***] period; and

 

(g)no sub-licence will carry any right to sub-sub-license.

 

2.4Notwithstanding clause 2.3, no prior written consent from Isis will be required for sub-licences if:

 

(a)the sub-licensee or an Affiliate of the sub-licensee, at the time of entering into a new sub-licence, is already a licensee or a sub-licensee of the Licensee in respect of all or part of the Licensed Technology; or

 

(b)the sub-licensee is a subsidiary or an Affiliate of the Licensee;

 

2

 

 

provided always that the sub-licence complies with provisions (a), (d) and (e) of clause 2.3.

 

2.5A decision by Isis not to give prior written consent under clause 2.3(b) or (c) shall be accompanied by a written description of the reasons for such disapproval, and the parties shall promptly (within [***]) discuss the reasons Isis has given and the Licensee may challenge such reasons.

 

3.Materials and Clinical Data

 

3.1Subject to clause 2.1 and the remainder of this clause 3, as between Isis and the Licensee the Materials and Clinical Data will remain the legal property of Isis and as at the date of this agreement the Materials and Clinical Data are held by the University.

 

3.2During the term of this agreement, the Licensee will have the right to access and use the Materials at the University, upon giving Isis [***] written notice, in the quantities set out in Schedule 2 to develop, make, have made, use and have used and Market the Licensed Product in accordance with the Licence. Upon the Licensee's prior written instruction, Isis will, at the Licensee's cost, deliver the Materials in the quantities set out in Schedule 2 to such address as notified by the Licensee within [***] of the Licensee's prior written instruction for the Licensee to use for the aforementioned purposes. Subject to the rights retained by the University to use the Materials for Non-Commercial Use, the Licensee's right to use the Materials will be exclusive in the Field save:

 

3.2.1in respect of the ChAdOx2 Vector the rights will be non-exclusive and subject to the terms of the ATCC MTA;

 

3.2.2in respect of the ChAdOx1 5T4 master seed bank and the MVA 5T4 non-GMP stock the rights will be subject to any access rights to which consortium members may be entitled under the terms of the FP7 Consortium and Funding Agreements; and Isis will not grant access to or allow a third party to use any of the Materials in the Field except in relation to the ChAdOx2 Vector.

 

3.3With regard to clause 3.2.1 and the ATCC MTA, Isis will use all reasonable endeavours to promptly agree a licence with ATCC to ensure that Isis can supply to the Licensee the ChAdOx2 non-GMP stock (Isis ref: [***]) under the ATCC MTA for commercial use and in order to Market Licensed Products.

 

3.4The Licensee will have the right to access, use and reproduce the Clinical Data in accordance with the Licence. The Licensee will give Isis at least [***] notice to access the Clinical Data. Upon the Licensee's prior written instruction, Isis will, at the Licensee's cost, deliver copies of the Clinical Data to such address as notified by the Licensee within [***] of the Licensee's prior written instruction for the Licensee to use to develop, make, have made, use and have used and Market the Licensed Product in accordance with the Licence.

 

4.Improvements

 

4.1The Licensed Technology covered by the Licence in clause 2 includes Inventor Improvements. Isis will communicate in writing to the Licensee within a reasonable time, and in any event [***] of becoming aware of the same, all Inventor Improvements.

 

4.2The Licensee acknowledges and agrees that all Intellectual Property Rights in Inventor Improvements belong to Isis.

 

4.3The Licensee will communicate in writing to Isis within [***] of intended publication all Licensee Improvements.

 

4.4Isis acknowledges and agrees that all Intellectual Property Rights in the Licensee Improvements belong to the Licensee.

 

3

 

 

5.Rights re Non-Commercial Use

 

5.1The Licensee grants Isis an irrevocable, perpetual, royalty-free licence to grant the University and those persons who at any time work or have worked on the Licensed Technology the licence set out in clause 5.2.

 

5.2Isis has granted and, in respect of Licensee Improvements, will grant, to the University and those persons who at any time work or have worked on the Licensed Technology a non- transferable, irrevocable, perpetual, royalty-free licence to use and publish the Licensed Technology and the Licensee Improvements for Non-Commercial Use.

 

5.3Where the University wishes to submit a publication including Licensee Improvements, Isis shall procure that the University will use all reasonable endeavours to submit such draft publication to the Licensee in writing not less than [***] in advance of the submission for publication. The Licensee may make a written request to the University to delay submission for publication if, in the Licensee's reasonable opinion, such delay is necessary in order to seek patent or similar protection for the Licensee Improvements. A delay imposed on submission for publication as a result of a written request made by the Licensee shall not last longer than is necessary to seek required protection; and therefore shall not exceed [***] from the date of receipt of the written request to delay submission for publication by the Licensee, although Isis will procure that the University will not unreasonably refuse a request from the Licensee for additional delay in the event that Intellectual Property Rights would otherwise be lost. Notification of the requirement for delay in submission for publication must be received by the University within [***] after the receipt of the notice of intention to publish by the Licensee, failing which the University shall be free to assume that the Licensee has no objection to the proposed publication.

 

5.4Isis reserves the right to grant Academic and Research licences to encourage basic research for Non-Commercial Use, whether conducted at an academic facility or subcontracted to a corporate facility, but not for the purposes of permitting commercialisation of the Licensed Technology licensed exclusively in the Field, or to authorise the development or marketing of products or services that are produced or supplied entirely or partially using the Licensed Technology.

 

6.Filing and Maintenance

 

6.1The Licensee will pay Isis the Past Patent Costs representing the Licensee's sole contribution to the patent costs incurred by Isis prior to the parties entering into this agreement, within [***] of receiving an invoice from Isis following execution of this agreement.

 

6.2Isis will, in consultation with the Licensee and at the Licensee's cost, prosecute, use all reasonable endeavours to maintain, and renew the Applications throughout the duration of this agreement and in relation to Application 4 will use all reasonable endeavours to file and maintain any further patent application to the extent it is required in order to provide patent coverage for the ChAdOx2 Vector. Isis will give all reasonable consideration to the views of the Licensee and will not unreasonably refuse to prosecute, maintain or renew Applications provided always that the Licensee agrees to bear the costs of such action according to this Clause 6.2. The Licensee will reimburse Isis for all costs, filing fees, lawyers' and patent agents' fees, expenses and outgoings of whatever nature incurred by Isis in the prosecution, maintenance and renewal of the Applications (including those incurred in opposition proceedings before the European Patent Office or in ex parte re-examination or inter partes review proceedings in the United States Patent and Trademark Office ("USPTO") or any similar proceedings before any patent office challenging the grant or validity of the Applications) within [***] of receiving an invoice from Isis. Isis shall be entitled to make it a condition of any action of Isis under this clause 6.2 that the Licensee provides Isis with sufficient money in advance to cover the costs likely to be incurred in the action.

 

6.3Where the Application is prosecuted in the USPTO and the Licensee is a small business concern as defined under the US Small Business Act (15USC632) Isis intends to pay reduced USPTO patent fees under US patent law 35 USC 41(h)(1). The Licensee will notify Isis as soon as reasonably possible if it or a sub-licensee ceases to be a small business concern as defined under the US Small Business Act (15USC632) or becomes aware of any other reason why it would not qualify for reduced USPTO patent fees under US patent law 35 USC 41(h)(1).

 

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6.4The Licensee shall inform Isis not less than [***] in advance of the National Phase filing deadline (noted in Schedule 2) of the territories within the scope of the PCT that it wishes to be covered in the National Phase of the Applications. In the event that the Licensee does not give the required minimum of [***] advance notice Isis shall then be entitled to proceed with filing the Applications at the Licensee's cost in whichever territories as it may in its sole discretion decide.

 

6.5The Licensee shall be entitled to remove any one or more of the countries from the Territory at any time by giving not less than [***] notice to Isis. If the Applications are proceeding under the PCT then such notice may not be given any earlier than the date for commencement of the National Phase filing. For the avoidance of doubt the Licensee shall remain liable for the costs mentioned in clause 6.2 that arise or are incurred by Isis during the said notice period in respect of the countries being removed.

 

6.6In the event that Isis elects to discontinue the prosecution and/or maintenance of any of the Applications, the Licensee shall have the right but not the obligation to take over prosecution and maintenance of the Applications Isis has elected to discontinue.

 

7.Infringement

 

7.1Each party will notify the other in writing of any misappropriation or infringement of any rights in the Licensed Technology of which the party becomes aware.

 

7.2The Licensee has the first right (but is not obliged) to take Legal Action at its own cost in relation to any misappropriation or infringement of any rights included in the Licensed Technology in the Field. The Licensee must discuss any proposed Legal Action with Isis prior to the Legal Action being commenced, and take due account of the legitimate interests of Isis in the Legal Action it takes provided always that the Licensee may act without further consultation if rights in the Licensed Technology would otherwise be prejudiced or lost.

 

7.3If the Licensee takes Legal Action under clause 7.2, the Licensee will:

 

(a)except where any Legal Action arises directly as a result of a breach by Isis of the warranties in Clause 13.2, indemnify and hold Isis and the University harmless against all costs (including lawyers' and patent agents' fees and expenses), claims, demands and liabilities arising out of or consequent upon a Legal Action and will settle any invoice received from Isis in respect of such costs, claims, demands and liabilities within [***] of receipt; and

 

(b)treat any account of profits or damages (including, without limitation, punitive damages) awarded in or paid to the Licensee under any settlement of the Legal Action for any misappropriation or infringement of any rights included in the Licensed Technology as Net Sales for the purposes of clause 9, having first for these purposes deducted from the award or settlement an amount equal to any legal costs incurred by the Licensee in the Legal Action that are not covered by an award of legal costs; and

 

(c)keep Isis regularly informed of the progress of the Legal Action, including, without limitation, any claims affecting the scope of the Licensed Technology.

 

7.4Isis may take Legal Action at its own cost in relation to any misappropriation or infringement of any rights included in the Licensed Intellectual Property in the Field where:

 

(a)the Licensee has notified Isis in writing that it does not intend to take any Legal Action in relation to any misappropriation or infringement of any rights included in the Licensed Technology in the Field;

 

(b)if having received professional advice with regard to any Legal Action within [***] of the notification under clause 7.1, and consulted with Isis, the Licensee does not take reasonable steps to act upon an agreed process for dealing with such misappropriation or infringement (which may include, for the avoidance of doubt, seeking a second opinion in respect of such professional advice) within any timescale agreed between Isis and the Licensee and in any event within [***] of notification under clause 7.1. Isis may take such Legal Action at its own cost provided it shall not settle any action without first consulting with the Licensee and taking account of the reasonable observations and requests of the Licensee.

 

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8.Confidentiality

 

8.1Subject to clauses 8.2, 8.3 and 8.4, each party (being a receiving or disclosing party as the case may be) will keep confidential the Confidential Information of the other party and will not disclose or supply the Confidential Information to any third party or use it for any purpose, except in accordance with the terms and objectives of this agreement.

 

8.2The Licensee may disclose to sub-licensees of the Licensed Technology such of the Confidential Information as is necessary for the exercise of any rights sub-licensed, provided that the Licensee shall ensure that such sub-licensees accept a continuing obligation of confidentiality on the same terms as this clause, and giving third party enforcement rights to Isis, before the Licensee makes any disclosure of the Confidential Information. The Licensee may also disclose the Licensed Technology to the extent reasonably required in connection with the conduct of its business including to potential investors, other business associates and professional advisors provided that such persons have agreed in writing to be bound by non-use and non-disclosure obligations that are no less strict than those set forth in this agreement or are subject to professional codes of conduct that prevent disclosure of client confidential information and the Licensee will take action in respect of any breach of such obligations.

 

8.3Confidential Information may be exchanged freely between Isis and the University and communications between those two parties shall not be regarded as disclosures, dissemination or publication for the purpose of this agreement. Isis may also disclose the terms of this agreement and royalty reports and payments made by the Licensee to any third parties that have rights to a revenue share for providing funding in the development of the Licensed Technology provided that such persons have agreed in writing to be bound by non-use and non-disclosure obligations that are no less strict than those set forth in this agreement or are subject to professional codes of conduct that prevent disclosure of client confidential information and Isis will take action in respect of any breach of such obligations.

 

8.4Clause 8.1 will not apply to any Confidential Information which:

 

(a)is known to the receiving party before disclosure, and not subject to any obligation of confidentiality owed to the disclosing party;

 

(b)is or becomes publicly known without the fault of the receiving party;

 

(c)is obtained by the receiving party from a third party in circumstances where the receiving party has no reason to believe that it is subject to an obligation of confidentiality owed to the disclosing party;

 

(d)the receiving party can establish by reasonable proof was substantially and independently developed by officers or employees of the receiving party who had no knowledge of the disclosing party's Confidential Information; or

 

(e)is approved for release in writing by an authorised representative of the disclosing party.

 

8.5Nothing in this agreement will prevent a party from disclosing Confidential Information where it is required to do so by law or regulation, stock exchange rules, or by order of a court or competent authority, provided that, in the case of a disclosure under the Freedom of Information Act 2000 ("FOIA"), none of the exemptions in the FOIA applies to the relevant Confidential Information and provided always that, to the extent permitted by law or regulation, the receiving party will give such notice as is reasonably practicable in the circumstances to the disclosing party about the timing and content of such a disclosure.

 

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8.6If either party to this agreement receives a request under the FOIA to disclose any information that, under this agreement, is the other party's Confidential Information, it will notify and consult with the other party. The other party will respond within [***] after receiving notice if that notice requests the other party to provide information to assist in determining whether or not an exemption under the FOIA applies to the information requested under the FOIA.

 

9.Royalties and Other Payments

 

9.1Isis will invoice the Licensee for the Signing Fee shortly after signature of this agreement and the Licensee must settle the invoice within [***] of receipt.

 

9.2Subject to clause 9.3, the Licensee will pay to Isis a royalty equal to the applicable Royalty Rate on all Net Sales of Licensed Products for the duration of the agreement on the terms set out in clause 11.

 

9.3Following expiration or revocation of the last Valid Claim covering a Licensed Product in a country in which the Licensed Product is Marketed and where there is being Marketed and sold by a third party in the normal course of business a product that, directly or indirectly, competes with the Licensed Product, the Step Down Rate (as defined below) shall apply on a country-by-country basis to the applicable Royalty Rate of such Licensed Products. For the purposes of this clause 9.3, the "Step Down Rate" shall be the percentage decrease of (a) [***] compared against (b) [***].

 

9.4In the event that the royalties paid to Isis under clauses 9.2 or 9.6 do not amount to at least the Minimum Sum, the Licensee must make up the difference between the royalties paid under clauses 9.2 and 9.6 and the Minimum Sum in each Licence Year where a Minimum Sum applies.

 

9.5The Licensee will pay to Isis a royalty equal to the Fee Income Royalty Rate on any sublicensing fees that the Licensee receives for sublicensing the Licensed Technology with a third party. For the purposes of this clause 9.5, Sublicensing fees shall include upfront fees, milestone payments and other consideration received by the Licensee from such third party but shall exclude:

 

(a)milestones payable by a sub-licensee to the Licensee on a Milestone event (as detailed in Schedule 2) where a Milestone Triggering Event has been met; and

 

(b)royalties paid to the Licensee by a sub-licensee based on net sales of Licensed Products; and

 

(c)any sums received that are to be used to fund research and/or development.

 

9.6Subject to clause 9.3, the Licensee will pay to Isis a royalty equal to the Sublicensing Royalty Rate on any royalties paid to the Licensee by a sub-licensee based on net sales of Licensed Products by a sub-licensee.

 

9.7If the Licensee has to pay royalties to a third party (other than an Affiliate), for the right to make, have made, use or Market a Licensed Product, under a licence of Intellectual Property Rights without which the Licensed Technology cannot lawfully be exploited, then the Licensee will be entitled to deduct from all royalty payments due to Isis in respect of Net Sales of the Licensed Product under clause 9.2 an amount equal to [***] of the royalties actually paid to that third party, up to a maximum amount of [***] of the royalties due to Isis under clause 9.2.

 

9.8Where a Licensed Product is sold as part of a combination product or co-packaged product, the Net Sales from the combination product or the co-packaged product, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales of the combination product or the co-packaged product, during the applicable royalty reporting period, by the fraction:

 

[***]

 

Where A is the average sale price of the Licensed Product when sold separately in finished form, or if not sold separately, the market price of the Licensed Product if it were sold separately and B is the average sale price of the other product(s) included in the combination product or co-packaged product when sold separately in finished form, or if not sold separately, the aggregate market price of the other product(s) if it were sold separately in each case during the applicable royalty reporting period or, if sales of both the Licensed Product and the other product(s) did not occur in such period, then in the most recent royalty reporting period in which sales of both occurred. In the event that such average sale price cannot be determined for the Licensed Product and any other product(s) included in the combination product or co-packaged product, then the Net Sales for the purposes of determining royalty payments for a combination product or a co-packaged product shall be referred to an independent expert for determination.

 

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9.9Once a Milestone Triggering Event has occurred the Licensee will notify Isis as soon as possible after it or any sub-licensee achieves any Milestone, and, subject to receiving an invoice from Isis, pay to Isis the Milestone Fee, less any and all fees already paid or payable by the Licensee to Isis pursuant to Clause 9.5(a) in instances where a Milestone Triggering Event had not yet been met, in respect of each Milestone within [***] of the date on which each Milestone is achieved by the Licensee or a sub-licensee. In respect of an Investment Event, an Acquisition Event, a Partnering Event or Multiple Partnering Event, Milestone Fees payable against any Milestone that occurs prior to any of the Milestone Triggering Events being met will accrue and become payable once any one of the Investment Event, Acquisition Event or Partnering Event or Multiple Partnering Event is met. However, in respect of a Multiple Partnering Event, Milestone Fees will only accrue and become payable in respect of the applicable Field to which the Multiple Partnering Event relates.

 

9.10The Signing Fee and the Milestone Fee are non-refundable and will not be considered as an advance payment on royalties payable under clause 9.2. No part of the Minimum Sum will be refundable or applicable to succeeding Licence Years.

 

9.11Licensed Products supplied for use in any clinical trial carried out by or on behalf of the Licensee or any of its sub-licensees shall not be deemed to be sales and shall not be included within any Net Sales calculation.

 

9.12The Licensee or any of its sub-licensees may supply a commercially reasonable quantity of Licensed Products for promotional sampling provided that the number of Licensed Products supplied for promotional sampling shall not be greater than [***] of the total number of units of each Licensed Product sold leased or licensed by the Licensee in any Quarter following the Licensee receiving Marketing Authorization for the Licensed Product in any territory. Except as set out in this clause, the Licensee must not accept any non-monetary consideration when Marketing the Licensed Products or when issuing sub-licences of the Licensed Technology without the prior written consent of Isis, such consent not to be unreasonably withheld, conditioned or delayed. The Licensee may accept non-monetary consideration when Marketing the Licensed Products or when issuing sub-licences of the Licensed Technology provided either (a) [***] of such non-monetary consideration is able to be converted into cash within [***] of receipt from the Licensee to enable the Fee Income Royalty Rate to be paid to Isis in cash or (b) the Licensee covenants in writing to pay to Isis in cash, within [***] of receipt of the non-monetary consideration, the Fee Income Royalty Rate due to Isis.

 

9.13The Licensee will make all payments in pounds sterling or any currency replacing pounds sterling in its entirety.

 

9.14For the purposes of calculating any amount payable by the Licensee to Isis in a currency other than pounds sterling (or replacement currency), the Licensee shall apply an exchange rate equivalent to:

 

(a)the average of the applicable closing mid rates quoted by the Financial Times as published in London on the first Business Day of each month during the Quarter just closed; or

 

(b)for payments under clause 9.5 only, the first Business Day of the month in which the payment was received by the Licensee.

 

9.15Where the Licensee has to withhold tax by law, the Licensee will deduct the tax, pay it to the relevant taxing authority, and supply Isis with a Certificate of Tax Deduction at the time of payment to Isis. Where such an issue arises, the Licensee will not be liable for any costs or penalties associated with late payment to Isis provided that the Licensee takes reasonable steps to ensure that any such matters are dealt with as expeditiously as reasonably possible.

 

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9.16In the event that full payment of any amount due from the Licensee to Isis under this agreement is not made by any of the dates stipulated, the Licensee shall be liable to pay interest on the amount unpaid at the rate of [***] per annum over the base rate for the time being of Barclays Bank plc. Such interest shall accrue on a daily basis from the date when payment was due until the date of actual payment of the overdue amount, whether before or after judgment, and shall be compounded quarterly.

 

9.17If the Licensed Product is of a description covered by the Medicines Access Policy, the Licensee shall adhere to the requirements of the Medicines Access Policy. In particular in the event the Licensed Products can be used to ease the burden of illness in the developing world, the Marketing of Licensed Products will be managed in a manner that enables availability and accessibility at reasonable cost to the people most in need in the developing world.

 

10.Commercially Reasonable Endeavours

 

10.1Subject to clause 10.3, the Licensee must use Commercially Reasonable Endeavours to develop, exploit and Market the Licensed Technology to maximize the financial return for both parties.

 

10.2Subject to clause 10.3, the Licensee must use Commercially Reasonable Endeavours to develop, exploit and Market the Licensed Technology in accordance with the Development Plan as set out separately in respect of each Indication. The Licensee will:

 

10.2.1within [***] of the date of this agreement provide Isis with a detailed development plan covering the intended development of a Licensed Product for each Indication and that development plan will replace the summary development plan in Schedule 3 as the Development Plan. The Licensee will consult with Isis over the detailed development plan and will consider in good faith any comments that Isis may put forward. Following approval of the revised detailed development plan by Isis, the revised detailed development plan shall become the Development Plan; and

 

10.2.2deliver to Isis at least [***] prior to the commencement of each subsequent Licence Year a revised development plan for the intended development of a Licensed Product for each Indication together with any background supporting information necessary for Isis to evaluate the draft plan. The Licensee will consult with Isis over the draft plan and will consider in good faith any comments that Isis may put forward. Following approval of the revised development plan by Isis, the revised development plan shall become the Development Plan.

 

10.3The Licensee may give written notice to Isis that it no longer intends to develop, exploit and Market a Licensed Product in an Indication and following that notice:

 

10.3.1the Licensee will no longer have obligations to use Commercially Reasonable Endeavours to develop, exploit and Market a Licensed Product in that Indication; and

 

10.3.2the Indication will be removed from the Field and, without prejudice to any and all of its existing rights under this agreement, the Licensee will no longer have any exclusive rights to use the Licensed Technology in relation to that Indication.

 

11.Royalty Reports and Audit

 

11.1The Licensee will provide Isis with a report at least once in every [***] detailing the activities and achievements in its development of the Licensed Technology in order to facilitate its commercial exploitation, and in the development of potential Licensed Products.

 

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11.2The Licensee will provide Isis with a royalty report within [***] after the close of each Quarter for each Licensed Product Marketed by the Licensee and its sub-licensees. Each Royalty Report will:

 

(a)set out the Net Sales of each Licensed Product Marketed by the Licensee, including the total gross selling price of each Licensed Product Marketed by the Licensee and the quantity or total number of units of each Licensed Product Marketed by the Licensee;

 

(b)set out details of deductions made in the calculation of Net Sales from the invoiced price of each Licensed Product in the form in which it is Marketed by the Licensee;

 

(c)set out details of the quantity of Licensed Products used for promotional sampling by the Licensee or any sub licensees;

 

(d)provide a calculation of the royalties due from the Licensee to be paid at the Royalty Rate;

 

(e)set out details of payments received by the Licensee to which the Fee Income Royalty Rate applies and provide a calculation of the royalties due from the Licensee to be paid under the Fee Income Royalty Rate;

 

(f)provide a calculation of the royalties on sub-licensees' net sales received by the Licensee to which the Sub-Licensing Royalty Rate applies and provide a calculation of the royalties due from the Licensee to be paid at the Sub-licensing Royalty Rate including the quantity or total number of units of each Licensed Product Marketed by each sub-licensee;

 

(g)provide a statement showing whether or not royalties due exceed the Minimum Sum and, if so, by how much;

 

(h)set out details of Milestones achieved by the Licensee or any sub-licensees; and

 

(i)set out the steps taken during the Licence Year to promote and Market Licensed Products.

 

The Licensee must pay Isis the royalties due in respect of the Quarter just closed at the same time as the Licensee delivers the Royalty Report provided that, if requested, Isis will issue an invoice for the relevant payment prior to payment.

 

11.3The Licensee will deliver to Isis a periodic report at the close of each Licence Year providing sufficient data (in outline form) to give a reasonable indication or estimate of the actual or expected market share of the Licensee and its sub-licensees and will notify Isis in the event that its market share does or is expected to breach the limits set out in the 2014 Commission Regulation 316/2014 Technology Transfer Block Exemption Regulation and Guidelines in Commission Communication 2014/C 89/03 and any successor regulation. This obligation is not intended to place a significant additional financial burden on the Licensee.

 

11.4If a Licensed Product Marketed by the Licensee is re-Marketed by an Affiliate or an entity over which the Licensee exercises Control, the royalty on each such Licensed Product will be calculated on the highest of the prices at which it is Marketed or re-Marketed. For the avoidance of doubt, when a Licensed Product is sold to an arm's length distributor then Net Sales is calculated on the transfer price paid by the distributor to the Licensee.

 

11.5The Licensee must keep complete and proper records and accurate accounts of all Licensed Products used and Marketed by the Licensee and any sub-licensee in each Licence Year for at least [***]. Isis may, through an independent certified accountant appointed by Isis ("the Auditor"), audit all such accounts on at least [***] written notice no more than once each Licence Year for the purpose of determining the accuracy of the Royalty Reports and payments. The Auditor shall be:

 

11.5.1permitted by the Licensee to enter the Licensee's principal place of business upon reasonable notice to inspect such records and accounts;

 

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11.5.2entitled to take copies of or extracts from such records and accounts as are strictly necessary for the Auditor to properly conduct the audit;

 

11.5.3given all other information by the Licensee as may be necessary or appropriate to enable the amount of royalties payable to be ascertained including the provision of relevant records; and

 

11.5.4shall be allowed access to and permitted to conduct interviews of any sales, engineering or other staff of the Licensee in order to verify the accuracy of the records and accounts and the accuracy of any statements provided to Isis under clause 11.2.

 

If on any such audit a shortfall in payments of greater than [***] is discovered by the Auditor in respect of the audit period, the Licensee shall pay Isis's audit costs.

 

11.6The Licensee will ensure that equivalent obligations and access rights, as set out in clause 11.5, allowing Isis auditing rights to the sub-licensee are included in each sub licence agreement.

 

12.Duration and Termination

 

12.1This agreement will take effect on the date of signature. Subject to the possibility of earlier termination under the following provisions of this clause 12, and subject to the possibility of an extension to the term by mutual agreement, this agreement shall continue in force:

 

(a)until the expiry of the last Valid Claim anywhere in the world; and

 

(b)in any event for twenty (20) years from the date of this agreement.

 

12.2If either party commits a material breach of this agreement, and the breach is not remediable or (being remediable) is not remedied within the period allowed by notice given by the other party in writing calling on the party in breach to effect such remedy (such period being not less than [***], the other party may terminate this agreement by written notice having immediate effect.

 

12.3The Licensee may terminate this agreement for any reason at any time provided it gives Isis three (3) months' written notice to terminate expiring after the third anniversary of this agreement whereupon the Licensee shall bring all sub-licences to an end on the same date. Any such termination shall not absolve the Licensee of its obligation to accrue and pay royalties and other payments under the provisions of clause 9 in respect of the period prior to termination.

 

12.4Isis may terminate this agreement:

 

(a)immediately, if the Licensee has a petition presented for its winding-up (but excluding for this purpose any winding up petition presented against the Licensee in relation to any debt disputed by the Licensee), or passes a resolution for voluntary winding-up otherwise than for the purposes of a bona fide amalgamation or reconstruction, or compounds with its creditors, or has a receiver administrator or administrative receiver appointed of all or any part of its assets, or enters into any arrangements with creditors, or takes or suffers any similar action in consequence of debts;

 

(b)on [***] written notice if:

 

(i)the Licensee opposes or challenges the validity of any of the Applications or raises the claim that the Licensed Know-how is not necessary to develop and Market Licensed Products, provided always that nothing in this clause 12.4(b) will prevent the Licensee from seeking to determine whether a product of the Licensee is a Licensed Product for the purposes of this agreement; or

 

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(ii)the Licensee is in breach of clause 10.1 and the Licensee does not take any remedial action reasonably requested by Isis and notified to the Licensee by written notice pursuant to clause 12.2.

 

12.5On termination or expiration of this agreement, for whatever reason, the Licensee:

 

(a)must bring all sub-licences to an end on the same date;

 

(b)shall pay to Isis all outstanding royalties and other sums due under this agreement;

 

(c)shall provide Isis with details of the stocks of Licensed Products held at the point of termination;

 

(d)must cease to use or exploit the Licensed Technology, provided that this restriction does not apply to Licensed Know-How or Confidential Information which has entered the public domain through no fault of the Licensee, and that the Licensee may continue to use the Licensed Technology in order to meet any specific existing binding commitments already made by the Licensee at the date of termination and requiring delivery of Licensed Products within the next [***];

 

(e)must, at the option of Isis and at the Licensee's cost, destroy all other Licensed Products or send all other Licensed Products to a location nominated by Isis to the Licensee in writing;

 

(f)must cease to use the Materials and return to Isis any of the Materials in its possession or control; and

 

(g)grants Isis an irrevocable, transferable, non-exclusive licence to develop, make, have made, use and Market the Licensee's Improvements and products that incorporate, embody or otherwise exploit the same. Isis shall pay a reasonable royalty for use of this licence unless the termination arises under clause 12.4, or is by Isis under clause 12.2, in which case it shall be royalty-free.

 

12.6Termination of this agreement, whether for breach of this agreement or otherwise, shall not absolve the Licensee of its obligation to accrue and pay royalties under the provisions of clause 9 for the duration of any notice period and in respect of any dealings in Licensed Products permitted by clause 12.5.

 

12.7Clauses 1, 5.2, 7.3, 12.5, 12.7, 12.8, 13, 14.4 and 14.14 will survive the termination or expiration of this agreement, for whatever reason, indefinitely.

 

12.8Clauses 8 and 11.5 will survive the termination or expiration of this agreement, for whatever reason, for a period of [***].

 

13.Liability

 

13.1Subject to Clause 13.2 and to the fullest extent permissible by law, Isis does not make any warranties of any kind including, without limitation, warranties with respect to:

 

(a)the quality of the Licensed Technology;

 

(b)the suitability of the Licensed Technology for any particular use;

 

(c)whether use of the Licensed Technology will infringe third-party rights; or

 

(d)whether the Applications will be granted or the validity of any patent that issues in response to the Applications.

 

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13.2Isis warrants that as at the date of this agreement and subject to the terms of this agreement:

 

(a)it has full corporate power and authority to enter into the licences and license the Licensed Technology;

 

(b)the University has assigned all of its right, title and interest in the Licensed Technology subject to the licence back to the University for Non-Commercial Use set out in clause 5;

 

(c)it has the exclusive right to obtain the Materials pursuant to a material sales agreement with the University and has the full contractual right, power and authority to provide the Materials to the Licensee with such rights to use the Materials as set out in clause 3 of this agreement subject to the rights retained by the University to use the Materials for Non-Commercial Use;

 

(d)it has not created any licence, charge or mortgage over the Licensed Technology (excluding the ChAdOx2 Vector) in the Field;

 

(e)so far as Isis is aware (not having made any specific enquiries) there is no actual or threatened infringement of the Licensed Technology by any third party; and

 

(f)so far as Isis is aware, the Clinical Data and Materials have been created, procured or obtained in compliance with all applicable laws and regulations relating thereto.

 

13.3Except in relation to any claims, damages and liabilities arising directly from (i) a breach of this agreement by Isis, and/or (ii) the fraud, negligence or wilful misconduct of Isis or the University, the Licensee agrees to indemnify Isis and the University and hold Isis and the University harmless from and against any and all claims, damages and liabilities:

 

(a)asserted by third parties (including claims for negligence) which arise from the use of the Licensed Technology or the Marketing of Licensed Products by the Licensee and/or its sub-licensees; and/or

 

(b)arising directly from any breach by the Licensee of this agreement provided however that this indemnity for breach by the Licensee is subject to clause 13.6.

 

13.4Isis will use reasonable endeavours to defend any Indemnified Claim and to mitigate its losses, claims, liabilities, costs, charges and expenses or (at Isis's option) allow the Licensee to do so on its behalf (subject to the University retaining the right to be kept informed of progress in the action and to have reasonable input into its conduct). Isis will not (except as required by law) make any admission, compromise, settlement or discharge of any Indemnified Claim without the consent of the Licensee (which will not be unreasonably withheld or delayed).

 

13.5The Licensee undertakes to make no claim against any employee, student, agent or appointee of Isis or of the University, being a claim which seeks to enforce against any of them an liability whatsoever in connection with this agreement or its subject-matter.

 

13.6Subject to clause 13.8 and except in relation to the indemnities in clause 7.3 and 13.3(a), the liability of either party for any breach of this agreement in negligence or arising in any other way out of the subject-matter of this agreement, will not extend to incidental, indirect or consequential damages or loss of profits.

 

13.7Subject to clause 13.8, the liability of Isis to the Licensee accruing in any Licence Year under or otherwise in connection with this agreement or its subject-matter, including without limitation liability for negligence, shall in no event exceed:

 

(a)in respect of liability accruing in the first Licence Year, the amount of the Signing Fee paid to Isis; and

 

(b)in respect of liability accruing in any subsequent Licence Year, the total royalties paid in the previous Licence Year to Isis under clauses 9.2 and 9.6.

 

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13.8Nothing in this agreement shall limit or exclude any liability for fraud or fraudulent misrepresentation or death, or personal injury or any other liability which may not, by law, be excluded.

 

13.9Notwithstanding any other clause in this agreement, Isis shall not be entitled to profit from any grant of a licence to any third party in respect of the Licensed Technology that breaches the exclusive rights granted to the Licensee under clause 2 of this agreement ("a Licence to the Exclusive Rights"). In the event that the Licensee (acting in good faith) believes that Isis has granted a Licence to the Exclusive Rights, then the Licensee shall provide written notice to Isis with full particulars and all evidence supporting the Licensee's basis for such belief. Within [***] of receipt of written notice from the Licensee, Isis will notify the Licensee in writing whether it admits or disputes that it has granted a Licence to the Exclusive Rights. If Isis serves notice that it disputes that it has granted a Licence to the Exclusive Rights Isis and the Licensee shall enter into good faith negotiations in order to reach mutual agreement to resolve the dispute and if such mutual agreement is not reached within [***] after Isis's receipt of the Licensee's written notice, then the parties will refer the dispute to an independent expert ("Independent Expert") for determination on the following basis:

 

13.9.1the Independent Expert shall be agreed on by the parties, or, if agreement is not reached within [***] of either party giving notice to the other that it wishes to refer a matter to an Independent Expert, the Independent Expert may be nominated by the President of the Law Society of England and Wales on the request of either party;

 

13.9.2the Independent Expert shall be asked to determine:

 

(a)whether Isis has granted a Licence to the Exclusive Rights; and

 

(b)any dispute between the parties over the amount of consideration paid to Isis under any Licence to the Exclusive Rights.

 

13.9.3the Independent Expert shall act as an expert and not as an arbitrator;

 

13.9.4the Independent Expert's decision shall be final and binding on the parties in the absence of fraud or manifest error; and

 

13.9.5each party shall bear its own costs in relation to the reference to the Independent Expert. The Independent Expert's fees and any costs it properly incurs in arriving at its determination (including any fees and costs of any advisers appointed by the Independent Expert) shall be borne by the parties in equal shares or in such proportions as the Independent Expert may direct.

 

In the event that Isis has admitted or the Independent Expert has determined that Isis has granted a Licence to the Exclusive Rights then Isis will pay to the Licensee a sum equal to all consideration paid to Isis under the Licence to the Exclusive Rights (including consideration that is not in the form of cash payments where it is possible to put a cash value on such a payment). Isis will pay that sum to the Licensee as soon as possible and in any event no later than [***] following the date of admission by Isis or the Independent Expert's determination and will continue to pay a sum equal to all further consideration received by Isis under any such Licence to the Exclusive Rights no later than [***] after receipt. The parties agree that the payment of such sums to the Licensee represent the full amount of compensation to which the Licensee is entitled and the extent of Isis's liability to the Licensee for any grant by Isis of a Licence to the Exclusive Rights.

 

14.General

 

14.1Registration - The Licensee must register its interest in the Licensed Technology with any relevant authorities in the Territory as soon as legally possible. The Licensee must not, however, register an entire copy of this agreement in any part of the Territory or disclose its financial terms without the prior written consent of Isis (such consent not to be unreasonably withheld or delayed).

 

14.2Advertising - The Licensee must not use the name of Isis, the University or the Inventors (except those Inventors who are, or have at any time been, shareholders of the Licensee) in any advertising, promotional or sales literature, without Isis's prior written approval (such consent not to be unreasonably withheld or delayed).

 

14

 

 

14.3Packaging - The Licensee will ensure that the Licensed Products and the packaging associated with them are marked suitably with any relevant patent or patent application numbers to satisfy the laws of each of the countries in which the Licensed Products are sold or supplied and in which they are covered by the claims of any patent or patent application, to the intent that Isis shall not suffer any loss or any loss of damages in an infringement action.

 

14.4Thesis - This agreement shall not prevent or hinder registered students of the University from submitting for degrees of the University theses based on the Licensed Technology; or from following the University's procedures for examinations and for admission to postgraduate degree status.

 

14.5Taxes - Where the Licensee has to make a payment to Isis under this agreement which attracts value-added, sales, use, excise or other similar taxes or duties, the Licensee will be responsible for paying those taxes and duties.

 

14.6Notices - All notices to be sent to Isis under this agreement must indicate the Isis Project N° and should be sent, by post and fax unless agreed otherwise in writing, until further notice to: The Managing Director, Isis Innovation Ltd, Buxton Court, 3 West Way, Oxford OX2 OSZ, Fax: +44 (0)1865 280831. All notices to be sent to the Licensee under this agreement should be sent, until further notice, to the Licensee's Contact and Address indicating the Isis Project N°.

 

14.7Force Majeure - If performance by either party of any of its obligations under this agreement (not including an obligation to make payment) is prevented by circumstances beyond its reasonable control, that party will be excused from performance of that obligation for the duration of the relevant event.

 

14.8Assignment - The Licensee may assign any of its rights or obligations under this agreement in whole or in part to an Affiliate but only for so long as it remains an Affiliate and Isis shall at the request of the Licensee execute a deed of novation to bring about that assignment. Except as provided in this clause, the Licensee may not assign any of its rights or obligations under this agreement without the prior written consent of Isis (such consent not to be unreasonably withheld, delayed or conditioned except solely on the grounds that primarily relate to avoiding any detrimental reputational impact on the University or the assignee having insufficient funds to fulfil the obligations of this agreement, it being acknowledged and agreed that if the assignee is a publicly-listed company with a market capitalisation equal to or in excess of [***] it will be considered to have sufficient financial resources to develop and Market the Licensed Product). If Isis assigns its rights in the Licensed Technology to any person it shall do so expressly subject to the Licensee's rights under this agreement.

 

14.9Severability - If any of the provisions of this agreement is or becomes invalid, illegal or unenforceable, the validity, legality or enforceability of the remaining provisions will not in any way be affected or impaired. The parties will, however, negotiate to agree the terms of a mutually satisfactory provision, achieving as nearly as possible the same commercial effect, to be substituted for the provision found to be void or unenforceable.

 

14.10No Partnership etc - Nothing in this agreement creates, implies or evidences any partnership or joint venture between Isis and the Licensee or the relationship between them of principal and agent.

 

14.11Entire Agreement - This agreement constitutes the entire agreement between the parties in relation to the Licence to the exclusion of all other terms and conditions (including any terms or conditions which the Licensee purports to apply under any purchase order, confirmation order, specification or other document). The Licensee has not relied on any other statements or representations in agreeing to enter this agreement and waives all claims for breach of any warranty and all claims for any misrepresentation (negligent or of any other kind, unless made by Isis fraudulently) in relation to any representation which is not specifically set out in this agreement. Specifically, but without limitation, this agreement does not impose or imply any obligation on Isis or the University to conduct development work. Any arrangements for such work must be the subject of a separate agreement between the University and the Licensee.

 

15

 

 

14.12Variation - Any variation of this agreement must be in writing and signed by authorised signatories for both parties. For the avoidance of doubt, the parties to this agreement may rescind or vary this agreement without the consent of any party that has the benefit of clause 14.14.

 

14.13Waiver - No failure or delay by either party in enforcing its rights under this agreement, or at law or in equity will prejudice or restrict those rights. No waiver of any right will operate as a waiver of any other or later right or breach. Except as stated to the contrary in this agreement, no right, power or remedy conferred on, or reserved to, either party is exclusive of any other right, power or remedy available to it, and each of those rights, powers, and remedies is cumulative.

 

14.14Rights of Third Parties - The parties to this agreement intend that by virtue of the Contracts (Rights of Third Parties) Act 1999 the University and the people referred to in clause 13.5 will be able to enforce the terms of this agreement intended by the parties to be for their benefit as if the University and the people referred to in clause 13.5 were party to this agreement.

 

14.15Governing Law - This agreement is governed by English Law, and the parties submit to the exclusive jurisdiction of the English Courts for the resolution of any dispute which may arise out of or in connection with this agreement except in relation to any action in relation to Intellectual Property Rights or Confidential Information which may be brought in any court of competent jurisdiction.

 

16

 

 

Schedule 1

 

DEFINITIONS
(Clause 1)

 

Academic and Research Purposes means research, teaching or other scholarly use which is undertaken for the purposes of education and research.

 

Affiliate means any company or legal entity in any country Controlling or Controlled by the Licensee (or any legal entity in a country Controlling or Controlled by the sub-licensee).

 

Applications means:

 

(a)the patent applications set out as Applications 1, 2, 3 and 4 in Schedule 2;

 

(b)any patents granted in response to those applications;

 

(c)any corresponding foreign patents and applications which may be granted to Isis in the Territory based on and deriving priority from those applications; and

 

(d)any addition, continuation, continuation-in-part, division, reissue, renewal or extension based on the applications.

 

Acquisition Event means the Licensee being acquired by a third party and the purchase price is greater than or equal to [***].

 

ATCC MTA means the purchase order between the University and American Type Culture Collection (ATCC), a District of Columbia not-for-profit corporation, having its offices at 10801 University Boulevard, Manassas, Virginia 20110-2209, USA dated 24 February 2006 subject to the terms of ATCC's standard MTA dated 8 September 2003.

 

Business Day means a day, other than a Saturday or Sunday, on which clearing banks are permitted to open in London.

 

ChAdOx1 Vector means the DNA sequence of the AdY25 simian adenovirus with the El and E3 regions both deleted, and E4 Orf 4, 6, 6/7 replaced with the corresponding regions from AdHu5.

 

ChAdOx2 Vector means the DNA sequence of the C68 simian adenovirus with the following modifications so that the El region and the E3 region have both been deleted and the E4 region has been deleted and replaced with E4 Orf 1,2,3 from Y25 and E4 Orf 4, 6, 6/7 from AdHu5.

 

Clinical Data means the clinical data contained in the Isis clinical data projects set out in Schedule 2.

 

Clinical Patient Care means diagnosing, treating and/or managing the health of persons under the care of an individual having the right to use the Licensed Technology for Academic and Research Purposes in the event that such Licensed Technology is capable of application in a healthcare setting without further development.

 

Commercially Reasonable Endeavours means, in respect of each Indication to be developed in the Field separately, the effort a prudent and determined company of comparable size and sector to the Licensee would take to pursue the goal of developing and Marketing Licensed Products to maximize the financial return and in any event do no less than is required to fulfil the steps laid out in the Development Plan.

 

Confidential Information means in relation to each party any materials, trade secrets or other information disclosed by that party to the other, including, without limitation:

 

(a)the Licensed Technology, to the extent that it is not disclosed by the Application when published; and

 

17

 

 

(b)this agreement.

 

Control means:

 

(a)ownership of more than fifty percent (50%) of the voting share capital of the relevant entity; or

 

(b)the ability to direct the casting of more than fifty percent (50%) of the votes exercisable at a general meeting of the relevant entity on all, or substantially all, matters.

 

Development Plan means the plan set out in Schedule 3 as revised in accordance with clause 10.2.

 

Fee Income Royalty Rate means the fee income royalty rate set out in Schedule 2.

 

Field means the field set out in Schedule 2.

 

FP7 Consortium and Funding Agreements means the Improving Prostate Cancer with Vectored Vaccines (IMPROVE) EU grant agreement signed by the University on 12 July 2013 and the IMPROVE Consortium Agreement dated 10 June 2013.

 

Improvement means any development of the Licensed Technology which would, if commercially practised, infringe and/or be covered by a claim subsisting or being prosecuted in the Application.

 

Indemnified Claim means any claim under which Isis and the University are entitled to be indemnified under clause 13.3.

 

Indication means each indication for which a vaccine is to be developed by the Licensee in the Field including influenza, cancer, varicella zoster and MERS.

 

Initial Public Offering means an initial public offering of the Licensee's shares on a stock exchange on any market where such shares are offered to private and/or institutional investors.

 

Intellectual Property Rights means patents, trade marks, copyrights, database rights, rights in designs, and all or any other intellectual or industrial property rights, whether or not registered or capable of registration.

 

Inventor means the inventor or inventors named in the Applications and identified in Schedule 2.

 

Inventor Improvements means any Improvements made prior to the second anniversary of the date of this agreement solely by the Inventor within the Field, and the Intellectual Property Rights pertaining to them, of which Isis has been made aware and is legally able to license but shall not include, for the avoidance of doubt, any Improvements and Intellectual Property Rights developed pursuant to any employment or consultancy arrangements with Licensee or its Affiliates.

 

Investment Event means the Licensee achieving a company valuation greater than or equal to [***] determined by private fund raising or an Initial Public Offering.

 

Legal Action means commencing or defending any proceedings before a court or tribunal in any jurisdiction in relation to any rights included in the Licensed Technology including all claims and counterclaims for infringement and for declarations of non-infringement or invalidity.

 

Licence means the licence granted by Isis to the Licensee under clause 2.1.

 

Licensed Intellectual Property Rights means the Applications and (to the extent they constitute Intellectual Property Rights) the Inventor's Improvements.

 

Licensed Know-how means all confidential information relating to the Applications, the Materials and/or the Clinical Data that has been communicated to the Licensee by Isis in writing before the date of this agreement or is communicated in writing to the Licensee by Isis under this agreement and within [***] after the date of this agreement including but not limited to the construction and design of viral vectors.

 

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Licensed Product means any product, process, service or composition which is entirely or partially produced by means of or with the use of, or within the scope of, the Licensed Technology, or any of it.

 

Licensed Technology means the Licensed Intellectual Property Rights, the Clinical Data and the Licensed Know-How, and such (if any) other Intellectual Property Rights owned by or licensed to Isis as may be specifically identified in Schedule 2 (to the extent, in the case of licensed rights, that Isis is legally able to grant a sub-licence of the same).

 

Licensee's Contact and Address means the address for the Licensee set out in Schedule 2 of this agreement.

 

Licensee Improvements means any Improvements made prior to the second anniversary of the date of this agreement by the Licensee, and the Intellectual Property Rights pertaining to them, which shall include, for the avoidance of doubt, any Improvements and Intellectual Property Rights developed by an Inventor pursuant to an employment or consultancy arrangement with the Licensee.

 

Licence Year means each twelve (12) month period beginning on the date of this agreement and each anniversary of the date of this agreement.

 

Market means, in relation to a Licensed Product, offering to sell, lease, licence or otherwise commercially exploit the Licensed Product or the sale, lease, licence or other commercial exploitation of the Licensed Product.

 

Materials means the materials set out in Schedule 2.

 

Medicines Access Policy means the policy of the University to promote access to pharmaceutical and other products and services, the current version of which is available at www.admin.ox.ac.uk/researchsupport/integrity/access.

 

Milestone and Milestone Fee means the milestones, and the amounts payable on achievement of each of the milestones, set out in Schedule 2.

 

Minimum Sum means the minimum sum or sums set out in Schedule 2.

 

Net Sales means the gross amount invoiced for sales or other dispositions of Licensed Products by Licensee or its Affiliates in bona fide arms-length transactions with third parties, less the following deductions:

 

(a)trade, and/or quality discounts, returns, allowances, in amounts customary in the trade and actually given;

 

(b)import, export, excise, sales or use taxes, value added taxes and other taxes, tariffs or duties to the extent such items are included in the gross invoice price and actually paid;

 

(c)freight, handling, transportation and insurance prepaid or allowed if separately identified in such invoice and actually paid; and

 

(d)amounts allowed or credited or retroactive price reductions or rebates and actually given/paid.

 

Any refund of any of the foregoing amounts (including any reversal of bad debt allowances) previously deducted from Net Sales shall be appropriately credited upon receipt.

 

The Licensee may, at its option, allocate the above deductions from sales of Licensed Products based upon accruals estimated reasonably and consistent with the Licensee's standard business practices. If the Licensee elects to utilise such accruals, actual deductions will be calculated and, if applicable, a "true-up" made, on an annual basis.

 

A transfer of a Licensed Product from Licensee to an Affiliate shall not be deemed to be a sale hereunder provided that if a sale of a Licensed Product is to an Affiliate of the Licensee and such Affiliate is the end user of the Licensed Product, then the "amount invoiced" with respect to such sale shall, for the purposes of calculating "Net Sales", be the greater of (a) the actual amount invoiced and (b) the amount which the invoiced amount would have been had such sale of the Licensed Product been to a person at arm's length with the Licensee.

 

19

 

 

Non-Commercial Use means Academic and Research Purposes and the purposes of Clinical Patient Care. This includes the right for the University to license the Licensed Technology to any of its collaborators in connection with and solely for the University's Academic and Research Purposes; but it does not include the right to commercially exploit the Licensed Technology or grant any license to commercially exploit the Licensed Technology.

 

Marketing Authorisation means a marketing authorization granted by a regulatory authority such as the Food and Drug Administration or European Medicines Agency necessary to Market a Licensed Product in a given country

 

Milestone Triggering Event means any one of an Investment Event, an Acquisition Event, a Partnering Event, or a Multiple Partnering Event.

 

Multiple Partnering Event means in respect of each Field separately, the Licensee receiving income totalling [***] or more from third party partnering arrangements relating to the Licensed Technology.

 

Partnering Event means the Licensee enters into a partnering arrangement with a third party and the company valuation at that time, as assessed by a third party valuation expert, is greater than or equal to [***].

 

Past Patent Costs means the past patent costs set out in Schedule 2.

 

Project means the projects referred to in BACKGROUND.

 

Quarter means each period of three calendar months during a Licence Year with the first Quarter commencing on the first day of each Licence Year.

 

Royalty Rate means the royalty rate or rates set out in Schedule 2 on Net Sales of Licensed Products for, as applicable, influenza, cancer, varicella zoster and MERS.

 

Royalty Report means the report to be prepared by the Licensee under clause 11.2.

 

Signing Fee means the signing fee set out in Schedule 2.

 

Sub-licensing Royalty Rate means the sub-licensing royalty rate set out in Schedule 2.

 

Territory means the territory or territories set out in Schedule 2, excluding any territory or territories removed through the operation of clause 6.5.

 

University means the Chancellor, Masters and Scholars of the University of Oxford whose administrative offices are at the University Offices, Wellington Square, Oxford OX1 2JD.

 

Valid Claim means a granted or currently pending claim included in the Applications that has not expired nor been held permanently revoked, unpatentable, invalid or unenforceable by a court or tribunal of competent jurisdiction in a final and non-appealable judgment; nor been rendered unenforceable through disclaimer or otherwise abandoned.

 

20

 

 

Schedule 2

 

Application 1: [***]
   
Application 2: [***]
   
Application 3: [***]
   
Application 4: [***]
   
Clinical Data: [***]
   
Materials: [***]

 

Master Seedbank Volume
[***] [***]
[***] [***]
[***] [***]
Non-GMP stocks Volume
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]

 

Inventor:  
 

Application 1: [***]

 

Application 2: [***]

 

Application 3: [***]

 

Application 4: [***]

 

Territory (clause 2.1): Worldwide
   
Field (clause 2.1): Influenza vaccines for humans, cancer vaccines for humans including therapeutic and prophylactic applications, Varicella zoster vaccines for humans, MERS vaccines
   
ChAdOx1 Excluded Fields (clause 2.1): Malaria, tuberculosis, HIV, Neisseria meningitidis, human papilloma virus, hepatitis C virus, hepatitis B virus, Rift Valley Fever, dengue virus, Staphylococcus aureus, Ebola virus, Chagas disease, Chikungunya virus, pneumococcal disease, Marburg virus disease, Lassa fever, respiratory syncytial virus, Crimean-Congo haemorrhagic fever, severe acute respiratory syndrome (SARS), Hendra virus, Nipah virus, West Nile virus, Venezuelan equine encephalitis virus, Hanta Virus.
   
ChAdOx2 Excluded Fields (clause 2.1): Therapeutic vaccines for Crohn's disease and vaccines against rabies virus.

 

21

 

 

Past Patent Costs (clause 6.1): [***]
   
Signing Fee (clause 9.1): £100,000
   
Royalty Rate (clause 9.2): [***]
   
Minimum Sum (clause 9.4): Licence Year Minimum Sum
5 [***]
6 [***]
7 and each year thereafter [***]
   
 
Fee Income Royalty Rate (clause 9.5):

[***]       where the sublicensing or partnering arrangement takes place during the first three Licence Years.

 

[***]       where the sublicensing or partnering arrangement takes place after the third Licence Year.

 

Sub-Licensing Royalty Rate (clause 9.6):

[***]       where the Licensee enters into the sublicensing agreement during the first three Licence Years.

 

[***]       where the Licensee enters into the sublicensing agreement after the third Licence Year.

 

Milestone and Milestone Fee (clause 9.9):

 

1)       first Licensed Product for influenza:

 

Milestone Milestone Fee
Successful completion of Phase lib trial [***]
Initiation of phase III clinical trial [***]
Marketing Authorisation and pricing and reimbursement approval first major territory [***]
Marketing Authorisation and pricing and reimbursement approval second major territory [***]
First calendar year in which annual Net Sales of Licensed Product exceed [***] [***]

 

2)       second Licensed Product for influenza:

 

Milestone Milestone Fee
Successful completion of Phase lib trial [***]
Initiation of phase III clinical trial [***]
Marketing Authorisation and pricing and reimbursement approval first major territory [***]
Marketing Authorisation and pricing and reimbursement approval second major territory [***]
First calendar year in which annual Net Sales of Licensed Product exceed [***] [***]

 

3)       first Licensed Product for cancer:

 

Milestone Milestone Fee
Successful completion of Phase lib trial [***]
Initiation of phase III clinical trial [***]
Marketing Authorisation and pricing and reimbursement approval first major territory [***]
Marketing Authorisation and pricing and reimbursement approval second major territory [***]
First calendar year in which annual Net Sales of Licensed Product exceed [***] [***]

 

22

 

4)       second Licensed Product for cancer:

 

Milestone Milestone Fee
Successful completion of Phase II trial [***]
Initiation of phase III clinical trial [***]
Marketing Authorisation and pricing and reimbursement approval first major territory [***]
Marketing Authorisation and pricing and reimbursement approval second major territory [***]
First calendar year in which annual Net Sales of Licensed Product exceed [***] [***]

 

5)       first Licensed Product for varicella zoster:

 

Milestone Milestone Fee
Successful completion of Phase II trial [***]
Initiation of phase III clinical trial [***]
Marketing Authorisation and pricing and reimbursement approval first major territory [***]
Marketing Authorisation and pricing and reimbursement approval second major territory [***]
First calendar year in which annual Net Sales of Licensed Product exceed [***] [***]

 

6)       first Licensed Product for MERS:

 

Milestone Milestone Fee
Successful completion of first efficacy trial in camels [***]
Successful completion of Phase II trial [***]
Initiation of phase III clinical trial [***]
First Marketing Authorisation for camels [***]
First Marketing Authorisation and pricing and reimbursement approval for humans [***]
First calendar year in which annual Net Sales of Licensed Product exceed [***] [***]

 

For the purposes of these Milestones:

 

"Successful completion" of trials means the trial meets it primary endpoints and that the results justify commercial and scientific progression to the next stage of trial.

 

"Initiation" of new trials means the first administration of the trial drug in the first study subject recruited in accordance with the approved study protocol.

 

Licensee's Contact and Address (clause 14.6):

 

Contact Dr Andrew Mclean
Address

Oxford Sciences Innovation

The Weston Library

Broad Street

Oxford

OX1 3BG

Email [***]

 

23

 

 

Schedule 3

 

Vaccitech Outline Clinical Development Plan

 

[***]

 

Schedule 4

 

DEED OF COVENANT

 

Isis Innovation Limited
University Offices,
Wellington Square,
Oxford OX1 2JD,
England

 

Date: [insert date]

 

Dear Sirs,

 

Sub-Licence between Vaccitech Limited ("Vaccitech") and [insert details of Sub-Licensee] dated [insert date] (the "Sub-Licence")

 

As part consideration for the grant of a sub-licence from Vaccitech to use [insert details of licensed technology] (the "Licensed Technology"), the Sub-Licensee hereby covenant to Isis Innovation Limited (Isis) and Isis covenant with the Sub-Licensee that:

 

1.should the head licence between Vaccitech and Isis be terminated for whatever reason, Isis and the Sub-Licensee shall enter into a direct licence containing the same obligations and liabilities as set forth in the Sub-Licence and the Sub-Licensee will pay all due and payable under the Sub-Licence to Isis;

 

2.should the Sub-Licensee wish to further sub-licence the Licensed Technology where Isis has consented to the Sub-Licence including the right to do so, it shall procure that any sub-sub-licensee enters into a Deed of Covenant with Isis in a form substantially similar to this Deed of Covenant;

 

3.Isis shall have the right, during the term of the Sub-Licence, through an independent certified accountant appointed by Isis (the "Auditor"), to audit all accounts on at least [***] written notice no more than once each calendar year for the purpose of determining the accuracy of the royalty reports and payments. The Auditor shall be:

 

a.permitted to enter the principal place of business of the Sub-Licensee upon reasonable notice to inspect such records and accounts;

 

b.entitled to take copies of or extracts from such records and accounts;

 

c.given all other information by the Sub-Licensee as may be necessary or appropriate to enable the amount of royalties payable to be ascertained including the provision of relevant records; and

 

d.shall be allowed access to and permitted to conduct interviews of any sales, engineering or other staff of the Sub-Licensee in order to verify the accuracy of the records and accounts and the accuracy of any royalty statements provided to Vaccitech.

 

If on any such audit a shortfall in payments of greater than five percent (5%) is discovered by the Auditor in respect of the audit period, the Sub-Licensee shall pay the audit costs of Isis.

 

SIGNED AS A DEED by
[Insert details of Sub-Licensee] in the presence of:-

 

24

 

 

Signature of Witness:

 

Name of Witness:
Address:

 

SIGNED AS A DEED by
ISIS INNOVATION LIMITED in the presence of:-

 

Signature of Witness:

 

Name of Witness:
Address:

 

25

 

 

AS WITNESS this agreement has been signed by the duly authorised representatives of the parties.

 

SIGNED for and on behalf of
ISIS INNOVATION LIMITED:
SIGNED for and on behalf of
VACCITECH LIMITED
   
Name: Name:
   
Position: Position:
   
Signature: Signature:
   
Date: Date:

 

26

 

 

Letter of Variation

 

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.

 

Bill Enright
Vaccitech Limited
The Schrodinger Building
Heatley Road
The Oxford Science Park
Oxford
0X4 4GE

 

14th January 2019

 

Dear Bill,

 

OUI project numbers [***]

 

Amendment to the Licence of Technology between Oxford University Innovation Limited (previously registered as Isis Innovation Limited) (“OUI”) and Vaccitech Limited (“the Licensee”) dated 4th March 2016 (“the Licence Agreement”).

 

This letter (“Letter”) records an amendment to the Licence Agreement that OUI and the Licensee wish to extend the permitted field of use for the ChAdOx2 vector, make clarifications to the Field and to add the details of more recently filed patent applications to which the Licensee has rights under the Licence Agreement.

 

Defined terms used in this letter (unless stated to the contrary) have the same meaning as given to them in the Licence Agreement.

 

Amendment to the Licence Agreement

 

Accordingly, it is agreed as follows:

 

1.     Clause 2.1.1(d) shall be replaced in its entirety with the following:

 

(d)In relation to the use of the ChAdOx2 vector under Application 5, exclusive in the fields of i) vaccines encoding peptide sequences derived from the 5T4 oncofetal antigen, ii) personalised cancer vaccines, iii) vaccines for human papillomavirus (HPV) associated diseases including cancer, iv) vaccines encoding peptide sequences derived from the melanoma-associated antigen (MAGE-3) and/or New York oesophageal squamous cell carcinoma 1 (NYESO-1) cancer-testis antigen and nonexclusive in all other fields with the exclusion of all veterinary applications (apart from MERS) and the ChAdOx2 Excluded Fields.

 

2.     The definition of Field in Schedule 2 shall be replaced in its entirety with the following:

 

Field (clause 2.1):Influenza vaccines for humans, therapeutic and prophylactic cancer vaccines for humans including those associated with or resulting from viral infections, Varicella zoster vaccines for humans, MERS vaccines.

 

 

 

 

Letter of Variation

 

 

 

3.The definition of ChAdOx1 Excluded Fields shall be amended such that it reads:

 

ChAdOx1 Excluded Fields (clause 2.1):    Malaria, tuberculosis, HIV, Neisseria meningitidis, human papilloma virus infections other than those that cause or otherwise involve cancer, hepatitis C virus, hepatitis B virus, Rift Valley Fever, dengue virus, Staphylococcus aureus, Ebola virus, Chagas disease, Chikungunya virus, pneumococcal disease, Marburg virus disease, Lassa fever, respiratory syncytial virus, Crimean-Congo haemorrhagic fever, severe acute respiratory syndrome (SARS), Hendra virus, Nipah virus, West Nile virus, Venezuelan equine encephalitis virus, Hanta Virus.

 

4.The definition of ChAdOx2 Excluded Fields shall be amended such that it reads:

 

ChAdOx2 Excluded Fields (clause 2.1):     Therapeutic vaccines for Crohn’s disease, vaccines against rabies virus, and vaccines containing antigenic sequences derived from Mycobacterium avium subspecies paratuberculosis (MAP) for use in humans and animals for the treatment and prevention of diseases associated with MAP infection including but not limited to Crohn’s Disease, Psoriasis, Multiple Sclerosis, Parkinson’s Disease, Alzheimer’s Disease, Amyotrophic Lateral Sclerosis and Idiopathic Pulmonary Fibrosis.

 

5.The definition of Application 4 in Schedule 2 shall be replaced in its entirety with the following:

 

Application 4:                                                [***].

 

6.The following new definition for Applications 5:

 

Application 5:                                                [***].

 

7.Our respective rights and liabilities under the Licence Agreement which have accrued up to the effective date of this Letter will remain unaffected other than as may be expressly stated in this letter.

 

8.This Letter is supplemental to the Licence Agreement except as specifically amended by this letter the Licence Agreement shall continue in full force and effect in accordance with its terms.

 

9.This letter is governed by English Law and the parties submit to the exclusive jurisdiction of the English Courts for the resolution of dispute which may arise out of or in connection with this agreement except in relation to any action in relation to Intellectual Property Rights or Confidential Information which may be sought in any court of competent jurisdiction.

 

 

 

Letter of Variation

 

 

 

Please countersign and date a copy of this letter and return to me to Indicate agreement to the variations to the License Agreement as set out in this letter. If we have not yet signed the letter, we will do so and return a fully executed copy to you after receiving your signed copy.

 

Signed for and on behalf of Oxford University Innovation Limited

 

  

 

Position:     Dated:  

 

I, PRINT NAME: acting for and on behalf of

 

Vaccitech Limited hereby agree to the contents of this letter.

 

Signed:     Dated:  

 

Position:        

 

 

 

Confidential

 

DATED 29 April 2020

 

(1)          Oxford University Innovation Limited

 
- and -
 
(2)          Vaccitech Limited
 

 

 

Amendment, Assignment and Revenue Share Agreement

 

Concerning SARS-CoV2

 

 

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.

 

Bristows LLP
100 Victoria Embankment
London
EC4Y ODH

 

 

 

Confidential

 

THIS AGREEMENT is made the 29th day of April 2020

 

BETWEEN:-

 

(1)Oxford University Innovation Limited, a company incorporated under the laws of England and Wales under company registration number 02199542, whose registered office is at University Offices, Wellington Square, Oxford, 0X1 2JD (“OUI”); and

 

(2)Vaccitech Limited, a company incorporated under the laws of England and Wales under company registration number 09973585, whose registered office is at The Schrodinger Building 2nd Floor, Heatley Road, Oxford Science Park, Oxford, Oxfordshire, England, 0X4 4GE (“Vaccitech”).

 

BACKGROUND:

 

(A)OUI and Vaccitech entered into a Licence of Technology dated 4 March 2016, as amended by a letter variation dated 14 January 2019 (the “Licence Agreement”).

 

(B)Under the Licence Agreement, OUI granted Vaccitech a licence to certain vaccine technology, which was exclusive in certain fields and non-exclusive in other fields. Vaccitech’s non-exclusive licence includes a licence under certain OUI patent rights to use the ChAdOx1 and ChAdOx2 vectors and the adenovirus long promoter’ in the field of SARS-CoV2.

 

(C)In response to the global COVID-19 pandemic, Oxford University is currently conducting a Phase I clinical trial of a vaccine based on the ChAdOx1 vector.

 

(D)The vaccine is the subject of the Patent Application (as defined below). Vaccitech and OUI jointly own me rights io the Patent Application.

 

(E)In order to enable the vaccine to be quickly manufactured at scale and distributed to meet global demand, the resources and expertise of one or more global pharmaceutical companies will be required

 

(F)In order to vest all intellectual property rights in the vaccine in OUI, the Parties have agreed to: (a) amend the Licence Agreement; and (b) assign all of Vaccitech’s rights in the Patent Application and the Other Vaccine IPRs to OUI, in each case in accordance with the provisions of this Agreement. In return, the Parties have agreed to provide Vaccitech with a share of revenue that OUI receives in connection with the commercialisation of the Vaccine in accordance with the provisions of this Agreement

 

THE PARTIES AGREE AS FOLLOWS:

 

1.DEFINITIONS

 

In this Agreement, the following words and expressions shall have the following meanings -

 

1.1 Adenovirus Long Promoter the promoter that is claimed in international patent application number [***];
1.2 Affiliate* in relation to Vaccitech (the “subject”), any other entity that at the date of this Agreement (i) directly or indirectly controls, is controlled by, or is under common control with the subject.  In the case of entities having stocks, shares or a similar ownership designation “control” and ‘‘controlled” means beneficial ownership of more than fifty percent of the voting stock, shares or similar ownership designation.  In the case of any other entity, “control’ and “controlled’’ shall exist through the ability to directly or indirectly control the management and/or business of the other entity.  In this provision “entity” means any individual, firm, company, corporation or other corporate body or legal entity, or any joint venture, association or partnership (whether or not having a separate legal personality);

 

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1.3 ChAdOx1 Vector the DNA sequence of the AdY25 simian adenovirus with the E1 and E3 regions both deleted, and E4 Orf 4, 6, 6/7 replaced with the corresponding regions from AdHu5, or any other vector that is claimed in international patent application number [***];
1.4 ChAdOx2 Vector [***], or any other vector that is claimed in international patent application number [***];
1.5 Intellectual Property Rights patents, petty patents, utility models, any extensions of the exclusivity granted in connection with the foregoing, registered, designs, trademarks, service marks, applications for any of the foregoing (including continuations, continuations-in-part and divisional applications), the right to claim priority from, the right to apply for and be granted any of the foregoing, rights in inventions, trade names, business names, brand names, get-up, logos, domain names, URLs, copyrights, design rights, database rights, publication rights, performance rights, rights in know-how, trade secrets and confidential information and all other forms of intellectual property right which may exist anywhere in the world;
1.6 Other Vaccine IPRs

all Intellectual Property Rights owned solely (or jointly with OUI) by Vaccitech or Vaccitech’s Affiliates:

 

(a)   that exist as at the date of this Agreement and that relate solely to the Vaccine and/or solely to manufacture of the Vaccine, (including those Intellectual Property Rights that were developed or generated by [***] in the course of her work on the Vaccine, to the extent that the same relate solely to the Vaccine and/or solely to manufacture of the Vaccine);

 

(b)   that arise after the date of this Agreement and that relate solely to the Vaccine or solely to manufacture of the Vaccine; or

 

(c)   that relate solely to any variations, improvements, enhancements or modifications to the Vaccine;

 

in each case, provided that such Intellectual Property Rights do not relate to any other product or the manufacture of any other product; and excluding the Patent Application and the inventions disclosed in the Patent Application;

1.7 Patent Application patent application number [***]; and
1.8 Vaccine any ChAdOx1 Vector-based or ChAdOx2 Vector-based vaccine that is described and/or covered by a claim of the Patent Application document as filed on 13 March 2020.

 

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2.AMENDMENT OF LICENCE AGREEMENT
  
2.1The Licence Agreement shall be amended as follows with effect from the date of this Agreement

 

  2.1.1 The definition of ChAdOx1 Excluded Fields shall be amended by adding “and SARS-CoV2” to the end of the definition, so that it reads:

 

ChAdOx1 Excluded Fields (clause 2.1) Malaria, tuberculosis, HIV, Neisseria meningitidis, human papilloma virus infections other than those that cause or otherwise involve cancer, hepatitis C virus, hepatitis B virus, Rift Valley Fever, dengue virus, Staphylococcus aureus, Ebola virus, Chagas disease, Chikungunya virus, pneumococcal disease, Marburg virus disease, Lassa fever, respiratory syncytial virus, Crimean-Congo haemorrhagic fever, severe acute respiratory syndrome (SARS), Hendra virus, Nipah virus, West Nile virus, Venezuelan equine encephalitis virus, Hanta Virus, and SARS-CoV2

 

  2.1.2 The definition of ChAdOx2 Excluded Fields shall be amended by adding “vaccines against SARS-CoV2,” into the definition after the words “rabies virus,”, so that it reads:

 

ChAdOx2 Excluded Fields (clause 2.1) Therapeutic vaccines for Crohn’s disease, vaccines against rabies virus, vaccines against SARS-CoV2, and vaccines containing antigenic sequences derived from Mycobacterium avium subspecies paratuberculosis (MAP) for use in humans and animals for the treatment and prevention of diseases associated with MAP infection including but- not limited to Crohn’s Disease, Psoriasis, Multiple Sclerosis, Parkinson’s Disease, Alzheimer’s Disease, Amyotrophic Lateral Sclerosis and Idiopathic Pulmonary Fibrosis.

 

  2.1.3 Clause 2.1.1(a) of the Licence Agreement shall be amended by adding the word “both” just after the word ‘excluding’ and also adding the words “and SARS-CoV2” to the end of the definition, so that it reads:

 

   (a)in relation to Applications 1 and 2 (i) exclusive in the Field and (ii) non-exclusive in all other fields excluding both veterinary applications (apart from MERS) and SARS- CoV2;

 

2.2For the avoidance of doubt, from the date of this Agreement, Vaccitech shall (i) no longer be entitled to use the ChAdOx1 Vector, the ChAdOx2 Vector or the Adenovirus Long Promoter in the SARS-CoV2 field, and (ii) cease (or procure the cessation, as the case may be) immediately of any work that may be ongoing using the ChAdOx1 Vector, the ChAdOx2 Vector and/or the Adenovirus Long Promoter in the SARS-CoV2 field; pursuant to the Licence Agreement (in any such case, whether by itself, its Affiliates or in conjunction with any third party)

 

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3.ASSIGNMENT
  
3.1Vaccitech and OUI, as joint owners, hereby irrevocably, unconditionally and absolutely assign to OUI as sole owner, all right, title and interest it may have in and to the Patent Application, and in and to any and all inventions disclosed in the Patent Application, including

 

  3.1.1 the right to claim priority from the Patent Application and to prosecute and obtain the grant of a patent;
 
  3.1.2 the right to file divisional applications based on the Patent Application and to prosecute and obtain the grant of patent on each and any such divisional application;
 
  3.1.3 in respect of each and any invention disclosed in the Patent Application, the right to file applications, claim priority from such applications, and prosecute and obtain the grant of patent or similar protection in or in respect of any country or territory in the world;
 
  3.1.4 the absolute entitlement to any patents granted pursuant to the Patent Applications or any of the applications set out in Clause 3.1, 33.1.3; and
 
  3.1.5 the right to bring, make, oppose, defend, and appeal proceedings, claims or actions and obtain relief (and to retain any damages recovered) in respect of any infringement, or any other cause of action arising from ownership, of the Patent Application or any of the applications set out in Clause 3.1.3 or any patents granted on the foregoing, whether occurring before on or after the date of this Agreement.

 

3.2Vaccitech hereby irrevocably, unconditionally and absolutely assigns into the sole name of OUI all its right, title and interest in and to the Other Vaccine IPRs that exist as at the date of this Agreement, with the right to sue for damages and other relief for past infringement of any of the Other Vaccine IPRs that exist as at the date of this Agreement. To the extent that it is not legally possible to assign Other Vaccine IPRs which have not yet been created, Vaccitech shall hold such Other Vaccine IPRs on trust for the sole benefit of OUI and, to the extent not restricted by law or any agreement with any third party, assign them to OUI as and when requested by OUI pursuant to Clause 4, provided that to the extent that any third party has any right or interest in the same upon their creation, such holding on trust and assignment shall be subject to such right or interest of such third party.

 

4.FURTHER ASSURANCE

 

At OUI’s expense, Vaccitech shall, and shall procure its employees, its Affiliates, and the employees of its Affiliates shall, promptly execute such documents and perform such acts as may reasonably be required for the purpose of giving full effect to this Agreement and its subject matter. Without limiting the foregoing, this includes Vaccitech assisting OUI (at OUI’s expense) in obtaining, defending and enforcing any rights arising out of or comprised within the Patent Application and/or the Other Vaccine IPRs, and assisting with any other proceedings which may be brought by or against OUI, against or by any third party relating to the rights assigned by this Agreement.

 

5.WARRANTIES

 

5.1Each Party hereby warrants to the other that it has the full capacity and authority to enter into and perform this Agreement, and that doing so will not put it in breach of any contract or other arrangement with any third party.
  
5.2Vaccitech hereby warrants to OUI as at the date of this Agreement that

 

  5.2.1 it has the right to make the assignments set out in Clause 3, free from all third party rights (other than potential third party rights in Other Vaccine IPRs arising after the date of this Agreement):
 
  5.2.2 2 2 it has not assigned or licensed, or agreed to assign or license, any of its rights in the Patent Application or the Other Vaccine IPRs existing as at the date of this Agreement to any third party, or otherwise created any encumbrance over the same:
 
  5.2.3 [***] was its employee at the time of her work on the Vaccine, carrying out her duties in the course of her employment with Vaccitech: and
 
  5.2.4 so far as it is aware, no third party has any right, title or interest in or to the Patent Application or the Other Vaccine IPRs existing as at the date of this Agreement.

 

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Confidential

 

6.REVENUE SHARE

 

6.1In consideration for the amendments to the Licence Agreement set out in Clause 2 and the assignment in Clause 3, the Parties agree the revenue sharing arrangements set out in Schedule 1.

 

7.GENERAL

 

Interpretation

 

7.1 In this Agreement the headings are for convenience only and shall not affect the interpretation of this Agreement. Unless otherwise stated, all references to Clauses or Schedules are references to Clauses or schedules of this Agreement.
   
7.2 The Schedules attached to this Agreement shall form part of this Agreement.
   
7.3 References to Clauses and Schedules are to the clauses and schedules of this Agreement.
   
7.4 Any words following the terms “including”, “include”, “in particular”, “for example” or any similar expression shall be construed as illustrative and shall not limit the sense of the words, description, phrase or term preceding those terms Severability.
   
7.5 If any provision of this Agreement is declared by any judicial or other competent authority to be void, voidable, illegal or otherwise unenforceable then the remaining provisions of this Agreement shall continue in full force and effect The judicial or other competent authority making such determination shall have the power to limit, construe or reduce the duration, scope, activity and/or area of such provision, and/or delete specific words or phrases as necessary to render such provision enforceable.

 

Waiver

 

7.6 Failure or delay by a Party to exercise any right or remedy under this Agreement shall not be deemed to be a waiver of that right or remedy, or prevent that Party from exercising that or any other right or remedy on that occasion or on any other occasion.

 

Entire Agreement and Amendments

 

7.7 This Agreement constitutes the entire agreement and understanding of the Parties relating to the subject matter of this Agreement and supersedes all prior oral or written agreements, representations, understandings or arrangements between the Parties relating to the subject matter of this Agreement.
   
7.8 The Parties acknowledge that in entering into this Agreement they do not rely on any statement, representation (including any negligent misrepresentation but excluding any fraudulent misrepresentation), warranty, course of dealing, custom or understanding except for the warranties expressly set out in this Agreement.
   
7.9 No change shall be made to this Agreement except in writing signed by the duly authorised representatives of all Parties.

 

Confidentiality and Publicity

 

7.10 OUI and Vaccitech shall agree wording for a press release that refers to Vaccitech and its role in the development of the Vaccine, and OUI shall include such agreed wording in each press release that it issues in relation to the grant of any of its rights in the Vaccine to any third party and in any subsequent press release relating or referring to development of the Vaccine.

 

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Confidential

 

7.11 No Party shall disclose any information concerning this Agreement (including its existence, its provisions, or disputes relating to it) to any third party provided that a Party may disclose:-

 

7.11.1      any press releases agreed by the Parties and the information contained therein, and

 

7.11.2      information concerning this Agreement:

 

(a)           to its legal advisers, auditors and/or regulators,

 

(b)           to the extent required by law;

 

(c)           as necessary to enforce this Agreement; *

 

(d)           in the case of OUI, to Oxford University;

 

(e)           in the case of OUI, to licensees and potential licensees of OUI’s rights to the Vaccine, save that OUI shall not disclose any information in Schedule 1 to such licensees or potential licensees; and/or

 

(f)            in the case of OUI, as necessary or desirable for the purposes of registering its rights with applicable patent offices and other governmental authorities.

 

Third Party Rights

 

7.12 The Contracts (Rights of Third Parties) Act 1999 shall not apply in relation to this Agreement and nothing in this Agreement shall confer on any third party the right to enforce any provision of this Agreement.

 

Law and Jurisdiction

 

7.13 English law shall govern this Agreement including the formation, validity, interpretation, performance and any non-contractual causes of action arising out of or in connection with this Agreement.
   
7.14 The Parties submit irrevocably to the exclusive jurisdiction of the English courts in relation to any dispute arising out of or in connection with this Agreement.

 

Counterparts

 

7.15 This Agreement may be executed by exchange of signed counterparts (including those signed by way of electronic signature) as attachments to emails. Each counterpart that has been executed and delivered by a Party shall constitute an original of this Agreement, but all the counterparts shall together constitute the same agreement. If this Agreement is executed in counterparts, it shall not be effective unless and until each Party has executed and delivered a counterpart to the other Party.

 

Assignment

 

7.16 OUI may not assign or otherwise transfer any or its rights or obligations under this Agreement and may not assign its rights in respect of the Other Vaccine IPRs, the Patent Application or any inventions disclosed in the Patent Application, in each case without the prior written consent of Vaccitech, which may only be withheld where Vaccitech (acting reasonably) is not satisfied that its rights and entitlement under this Agreement is secured. Vaccitech may assign or transfer to any third party its rights to receive payments under this Agreement.

 

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Confidential

 

Schedule 1

 

Revenue Sharing Arrangements

 

In addition to the definitions set out elsewhere in this Agreement, in this Schedule the following words and expressions shall have the following meanings:-

 

Applicable Receipts means Net Receipts less OUI’s administrative fee of [***]
Net Receipts

means any and all payments and the value of all non-monetary consideration actually received by OUI with respect to any Relevant Vaccine IP under all Vaccine Licensing Agreements, excluding:

 

(a)       value added tax or other taxes paid to OUI; and

 

(b)       any payments received by OUI for reimbursement of GUI’s actual costs or expenses in connection with the drafting, filing, prosecution and maintenance of the Patent Application;

 

Relevant Vaccine IP

means:

 

(a)       the Patent Application or any other patent application claiming any invention described or claimed in the Patent Application;

 

(b)       the Other Vaccine IPRs; and/or

 

(c)       any right under the Licensed Technology (as defined in the Licence Agreement) to use the ChAdOx1 Vector, ChAdOx2 Vector and/or the Adenovirus Long Promoter in the SARS-COV2 field;

 

Reporting Period means each three (3) month period ending on the last day March, June, September and December; and
Vaccine Licensing
Agreement
means any agreement between OUI and a third party under which OUI grants such third party any rights under the Relevant Vaccine IP (including any option) to research, develop, make, have made, use, offer for sale, sell, have sold, import or export a Vaccine

 

1.OUI shall not grant to any third party any rights in respect of the Relevant Vaccine IP in consideration for any non-monetary consideration, without the prior written consent of Vaccitech, which consent shall be subject to the Parties reaching agreement as to the monetary value of such non-monetary consideration for the purposes of calculation and payment to Vaccitech of the royalty under this Agreement

 

Payment Obligation

 

2.OUI shall pay to Vaccitech twenty four per cent (24%) of all Applicable Receipts in each Reporting Period

 

3.Within [***] after the end of each Reporting Period, OUI shall provide to Vaccitech a report setting out the Net Receipts received by OUI under all Vaccine Licensing Agreements upon which OUI is required to make payments to Vaccitech pursuant to paragraph 1 above (a “Revenue Report”).

 

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4.Within [***] after the date OUl issues a Revenue Report and, provided Vaccitech issues OUl with a valid invoice (if requested at the time of the delivery of the Revenue Report by OUl), OUl shall pay the applicable payments due under paragraph-1- above on the Net Receipts which are the subject of such Revenue Report.

 

Payment Terms

 

5.All sums due to Vaccitech under this Agreement shall be paid in British pounds sterling, or such other currency as may be agreed in writing by the Parties from time to time, to such bank account as specified by Vaccitech from time to time Where Net Receipts are received in a currency other than British pounds sterling OUl shall convert the same to British pounds sterling in accordance with its standard procedures and provide to Vaccitech details of the currency conversion used.

 

6.If any payment is not paid by the due date, Vaccitech may charge interest on any outstanding amount of such payment on a daily basis at a rate equivalent to [***] per annum above the base rate of the Bank of England then in force in London.

 

7.OUl shall make all payments to Vaccitech under this Agreement without deduction or withholding for taxes except to the extent that any such deduction or withholding is required by law. Any tax required to be withheld on amounts payable under this Agreement will be paid by OUl to the appropriate governmental authority, and OUl will furnish Vaccitech with proof of payment of such tax.

 

8.Vaccitech may, upon written notice to OUl, appoint an independent accountant for the purpose of verifying the accuracy of the Revenue Report OUl shall make all relevant records available for inspection by such independent accountant during regular business hours upon reasonable advance notice from Vaccitech. Before beginning their audit, the independent accountant shall execute an undertaking to OUl to keep confidential all information reviewed during such audit provided that the conclusions of the audit and any payments owed may be disclosed to Vaccitech. If the audit reveals an underpayment by OUl, the underpaid amount along with any interest thereon shall be settled within [***] of the issue of the final report. If the audit reveals an underpayment by OUl of more than [***] in aggregate in respect of any period of 4 consecutive Reporting Periods, OUl shall pay the accountant’s fees in respect of that audit.

 

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AGREED by the Parties through their duly authorised representatives on the date written at the start of this Agreement-

 

For and on behalf of Oxford University Innovation Limited:- For and on behalf of Vaccitech Limited:-

 

Signed     Signed  
   
Full Name     Full Name  
   
Title     Title  

 

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Exhibit 10.4

 

DATED 2017

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.

 

(1)        OXFORD UNIVERSITY INNOVATION LIMITED

and

(2)         VACCITECH LIMITED

 

LICENCE OF TECHNOLOGY
(OUI PROJECT Nos.
[***])

 

 

 

THIS AGREEMENT is made on 2017

 

BETWEEN:

 

(1)OXFORD UNIVERSITY INNOVATION LIMITED (Company No. 2199542) whose registered office is at University Offices, Wellington Square, Oxford OX1 2JD, England (“OUI”); and

 

(2)VACCITECH LIMITED (Company No. 9973585) whose registered office is at King Charles House, Park End Street, Oxford, Oxfordshire, OX1 1JD (the “Licensee”).

 

BACKGROUND:

 

(A)The Licensed Technology is connected with OUI Projects [***] “Hepatitis B vaccine”, [***] “Human Papilloma Virus vaccine”, [***] “CD74 as Molecular Adjuvant”, [***] “Adenovirus vaccine vector (‘ChAdOx1’)” and [***] “ChAdOx2 - simian adenovirus vector”.

 

(B)The Licensee wishes to acquire a licence to the Licensed Technology in order to develop products in the area of therapeutic vaccines and OUI is willing to license the Licensed Technology to the Licensee, on the terms of this agreement.

 

AGREEMENT:

 

1.Interpretation

 

In this agreement (including its Schedules), any reference to a “clause” or “Schedule” is a reference to a clause of this agreement or a schedule to this agreement, as the case may be. Words and expressions used in this agreement have the meaning set out in Schedule 1.

 

2.Grant of Licence

 

2.1In consideration of the payments required to be made under this agreement by the Licensee, OUI grants to the Licensee a licence in the Territory in respect of the Licensed Technology to develop, make, have made, import, use and have used and Market the Licensed Product subject to the terms and conditions of this agreement. Subject to clause 4, the Licence in respect of:

 

2.1.1the Licensed Intellectual Property is :

 

(a)in relation to Applications 1 and 2 exclusive in all fields;

 

(b)in relation to Application 3 non-exclusive in the field of Hepatitis B therapy;

 

(c)in relation to Application 4 exclusive in the fields of Human Papilloma Virus associated diseases and Hepatitis B therapy;

 

(d)in relation to Application 5 exclusive in the field of Hepatitis B therapy; and

 

2.1.2the Licensed Know-how is non-exclusive in all fields.

 

2.2As soon as is reasonably possible after the date of this agreement (and in any event within [***] of the date of this agreement), OUI will, at OUI’s cost, supply the Licensee with the Documents. OUI shall, for a period of [***] from the date of this agreement, continue to provide the Licensee with such documents and materials as embody the Licensed Know-How generated during that period.

 

2.3The Licensee may grant sub-licences with the prior written consent of OUI, such consent not to be unreasonably withheld, conditioned or delayed, provided that:

 

1

 

 

(a)the sub-licensee has obligations to the Licensee commensurate with those which the Licensee has to OUI under this agreement, except the financial terms hereof or where it is not legally possible to include such obligations in the sub-licence;

 

(b)the nature of the proposed sub-licensee is not likely in OUI’s reasonable opinion to have any detrimental impact on the reputation of either OUI or of the University;

 

(c)the sub-licensee has sufficient financial resources to develop and Market the Licensed Product (it being acknowledged and agreed that if the sub-licensee is a publicly-listed company with a market capitalisation equal to or in excess of [***] it will be considered to have sufficient financial resources to develop and Market the Licensed Product);

 

(d)as soon as reasonably practicable following the grant of each sub-licence, the Licensee provides a certified copy of that sub-licence to OUI, such copy to be Confidential Information of the Licensee which may be redacted to the extent any information in such sub-licence does not relate to the Licensed Technology, OUI and/or this agreement;

 

(e)the sub-licensee enters into a Deed of Covenant with the Licensor in the form set out in Schedule 5;

 

(f)OUI will be deemed to have consented to a sub-licence within [***] of receipt of such written request by the Licensee to grant a sub-licence, provided it has not refused consent or requested reasonable further time or information to consider the request within such [***] period; and

 

(g)no sub-licence will carry any right to sub-sub-license.

 

2.4Notwithstanding clause 2.3, no prior written consent from OUI will be required for sublicences if:

 

(a)the sub-licensee or an Affiliate of the sub-licensee, at the time of entering into a new sub-licence, is already a licensee or a sub-licensee of the Licensee in respect of all or part of the Licensed Technology; or

 

(b)the sub-licensee Is a subsidiary or an Affiliate of the Licensee;

 

provided always that the sub-licence complies with provisions (a), (d) and (e) of clause 2.3.

 

2.5A decision by OUI not to give prior written consent under clause 2.3(b) or (c) shall be accompanied by a written description of the reasons for such disapproval, and the parties shall promptly (within [***]) discuss the reasons OUI has given and the Licensee may challenge such reasons.

 

3.Improvements

 

3.1The Licensed Technology covered by the Licence in clause 2 includes Inventor Improvements. OUI will communicate in writing to the Licensee within a reasonable time, and in any event within [***] of becoming aware of the same, all Inventor Improvements.

 

3.2The Licensee acknowledges and agrees that all Intellectual Property Rights in Inventor Improvements belong to OUI.

 

3.3The Licensee will communicate in writing to OUI within [***] of intended publication all Licensee Improvements.

 

3.4OUI acknowledges and agrees that all Intellectual Property Rights in the Licensee Improvements belong to the Licensee.

 

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4.Rights re Non-Commercial Use

 

4.1The Licensee grants OUI an irrevocable, perpetual, royalty-free licence to grant the University and those persons who at any time work or have worked on the Licensed Technology the licence set out in clause 4.2.

 

4.2OUI has granted and, in respect of Licensee Improvements, will grant, to the University and those persons who at any time work or have worked on the Licensed Technology a non- transferable, irrevocable, perpetual, royalty-free licence to use and publish the Licensed Technology and the Licensee Improvements for Non-Commercial Use.

 

4.3Where the University wishes to submit a publication including Licensee Improvements, OUI shall procure that the University will use all reasonable endeavours to submit such draft publication to the Licensee in writing not less than [***] in advance of the submission for publication. The Licensee may make a written request to the University to delay submission for publication if, in the Licensee’s reasonable opinion, such delay is necessary in order to seek patent or similar protection for the Licensee Improvements. A delay imposed on submission for publication as a result of a written request made by the Licensee shall not last longer than is necessary to seek required protection; and therefore shall not exceed [***] from the date of receipt of the written request to delay submission for publication by the Licensee, although OUI will procure that the University will not unreasonably refuse a request from the Licensee for additional delay in the event that Intellectual Property Rights would otherwise be lost. Notification of the requirement for delay in submission for publication must be received by the University within [***] after the receipt of the notice of intention to publish by the Licensee, failing which the University shall be free to assume that the Licensee has no objection to the proposed publication.

 

4.4OUI reserves the right to grant licences for Academic and Research Purposes to encourage basic research for Non-Commercial Use, whether conducted at an academic facility or subcontracted to a corporate facility, but not for the purposes of permitting commercialisation of the Licensed Technology licensed exclusively, or to authorise the development or marketing of products or services that are produced or supplied entirely or partially using the Licensed Technology.

 

5.Filing and Maintenance

 

5.1The Licensee will pay OUI the Past Patent Costs representing the Licensee’s sole contribution to the patent costs incurred by OUI prior to the parties entering into this agreement, within [***] of receiving an invoice from OUI following execution of this agreement.

 

5.2OUI will, in consultation with the Licensee and at the Licensee’s cost, prosecute, use all reasonable endeavours to maintain, and renew the Applications throughout the duration of this agreement. OUI will give all reasonable consideration to the views of the Licensee and will not unreasonably refuse to prosecute, maintain or renew Applications provided always that the Licensee agrees to bear the costs of such action according to this Clause 5.2. The Licensee will reimburse OUI for all costs, filing fees, lawyers’ and patent agents’ fees, expenses and outgoings of whatever nature incurred by OUI in the prosecution, maintenance and renewal of the Applications (including those incurred in opposition proceedings before the European Patent Office or in ex parte re-examination or inter partes review proceedings in the United States Patent and Trademark Office (“USPTO”) or any similar proceedings before any patent office challenging the grant or validity of the Applications) within [***] of receiving an invoice from OUI. OUI shall be entitled to make it a condition of any action of OUI under this clause 5.2 that the Licensee provides OUI with sufficient money in advance to cover the costs likely to be incurred in the action.

 

5.3Where any of the Applications are prosecuted in the USPTO and the Licensee is a small business concern as defined under the US Small Business Act (15USC632) OUI intends to pay reduced USPTO patent fees under US patent law 35USC 41(h)(1). The Licensee will notify OUI as soon as reasonably possible if it or a sub-licensee ceases to be a small business concern as defined under the US Small Business Act (15USC632) or becomes aware of any other reason why it would not qualify for reduced USPTO patent fees under US patent law 35 USC 41(h)(1).

 

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5.4The Licensee shall inform OUI not less than [***] in advance of the National Phase filing deadline (noted in Schedule 2) of the territories within the scope of the PCT that it wishes to be covered in the National Phase of the Applications. In the event that the Licensee does not give the required minimum of [***] advance notice OUI shall then be entitled to proceed with filing the Applications at the Licensee’s cost in whichever territories as it may in its sole discretion decide.

 

5.5The Licensee shall be entitled to remove any one or more of the countries from the Territory at any time by giving not less than [***] notice to OUI. If the Applications are proceeding under the PCT then such notice may not be given any earlier than the date for commencement of the National Phase filing. For the avoidance of doubt the Licensee shall remain liable for the costs mentioned in clause 5.2 that arise or are incurred by OUI during the said notice period in respect of the countries being removed.

 

5.6In the event that OUI elects to discontinue the prosecution and/or maintenance of any of the Applications, the Licensee shall have the right but not the obligation to take over prosecution and maintenance of the Applications OUI has elected to discontinue.

 

6.Infringement

 

6.1Each party will notify the other in writing of any misappropriation or infringement of any rights in the Licensed Technology of which the party becomes aware.

 

6.2The Licensee has the first right (but is not obliged) to take Legal Action at its own cost in relation to any misappropriation or infringement of any Licensed Technology that OUI has licensed exclusively to Licensee under this Agreement subject to any field restriction included in the rights granted in Clause 2.1. The Licensee must discuss any proposed Legal Action with OUI prior to the Legal Action being commenced, and take due account of the legitimate interests of OUI in the Legal Action it takes provided always that the Licensee may act without further consultation if rights in the Licensed Technology would otherwise be prejudiced or lost.

 

6.3If the Licensee takes Legal Action under clause 6.2, the Licensee will:

 

(a)except where any Legal Action arises directly as a result of a breach by OUI of the warranties in Clause 12.2, indemnify and hold OUI and the University harmless against all costs (including lawyers’ and patent agents’ fees and expenses), claims, demands and liabilities arising out of or consequent upon a Legal Action and will settle any invoice received from OUI in respect of such costs, claims, demands and liabilities within [***] of receipt; and

 

(b)treat any account of profits or damages (including, without limitation, punitive damages) awarded in or paid to the Licensee under any settlement of the Legal Action for any misappropriation or infringement of any rights included in the Licensed Technology as Net Sales for the purposes of clause 8, having first for these purposes deducted from the award or settlement an amount equal to any legal costs incurred by the Licensee in the Legal Action that are not covered by an award of legal costs; and

 

(c)keep OUI regularly informed of the progress of the Legal Action, including, without limitation, any claims affecting the scope of the Licensed Technology.

 

6.4OUI may take Legal Action at its own cost in relation to any misappropriation or infringement of any rights included in the Licensed Intellectual Property where:

 

(a)the Licensee has notified OUI in writing that it does not intend to take any Legal Action in relation to any misappropriation or infringement of any rights included in the Licensed Technology under clause 6.2;

 

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(b)if having received professional advice with regard to any Legal Action within [***] of the notification under clause 6.1, and consulted with OUI, the Licensee does not take reasonable steps to act upon an agreed process for dealing with such misappropriation or infringement (which may include, for the avoidance of doubt, seeking a second opinion in respect of such professional advice) within any timescale agreed between OUI and the Licensee and in any event within [***] of notification under clause 6.1, OUI may take such Legal Action at its own cost provided it shall not settle any action without first consulting with the Licensee and taking account of the reasonable observations and requests of the Licensee.

 

7.Confidentiality

 

7.1Subject to clauses 7.2, 7.3 and 7.4, each party (being a receiving or disclosing party as the case may be) will keep confidential the Confidential Information of the other party and will not disclose or supply the Confidential Information to any third party or use it for any purpose, except in accordance with the terms and objectives of this agreement.

 

7.2The Licensee may disclose to sub-licensees of the Licensed Technology such of the Confidential Information as is necessary for the exercise of any rights sub-licensed, provided that the Licensee shall ensure that such sub-licensees accept a continuing obligation of confidentiality on the same terms as this clause, and giving third party enforcement rights to OUI, before the Licensee makes any disclosure of the Confidential Information. The Licensee may also disclose the Licensed Technology to the extent reasonably required in connection with the conduct of its business including to potential investors, other business associates and professional advisors provided that such persons have agreed in writing to be bound by non-use and non-disclosure obligations that are no less strict than those set forth in this agreement or are subject to professional codes of conduct that prevent disclosure of client confidential information and the Licensee will take action in respect of any breach of such obligations.

 

7.3Confidential Information may be exchanged freely between OUI and the University and communications between those two parties shall not be regarded as disclosures, dissemination or publication for the purpose of this agreement. OUI may also disclose the terms of this agreement and royalty reports and payments made by the Licensee to any third parties that have rights to a revenue share for providing funding in the development of the Licensed Technology provided that such persons have agreed in writing to be bound by nonuse and non-disclosure obligations that are no less strict than those set forth in this agreement or are subject to professional codes of conduct that prevent disclosure of client confidential information and OUI will take action in respect of any breach of such obligations.

 

7.4Clause 7.1 will not apply to any Confidential Information which:

 

(a)is known to the receiving party before disclosure, and not subject to any obligation of confidentiality owed to the disclosing party;

 

(b)is or becomes publicly known without the fault of the receiving party;

 

(c)is obtained by the receiving party from a third party in circumstances where the receiving party has no reason to believe that it is subject to an obligation of confidentiality owed to the disclosing party;

 

(d)the receiving party can establish by reasonable proof was substantially and independently developed by officers or employees of the receiving party who had no knowledge of the disclosing party’s Confidential Information; or

 

(e)is approved for release in writing by an authorised representative of the disclosing party.

 

7.5Nothing in this agreement will prevent a party from disclosing Confidential Information where it is required to do so by law or regulation, stock exchange rules, or by order of a court or competent authority, provided that, in the case of a disclosure under the Freedom of Information Act 2000 (“FOIA”), none of the exemptions in the FOIA applies to the relevant Confidential Information and provided always that, to the extent permitted by law or regulation, the receiving party will give such notice as is reasonably practicable in the circumstances to the disclosing party about the timing and content of such a disclosure.

 

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7.6If either party to this agreement receives a request under the FOIA to disclose any information that, under this agreement, is the other party’s Confidential Information, it will notify and consult with the other party. The other party will respond within [***] after receiving notice if that notice requests the other party to provide information to assist in determining whether or not an exemption under the FOIA applies to the information requested under the FOIA.

 

8.Royalties and Other Payments

 

8.1OUI will invoice the Licensee for the Signing Fee shortly after signature of this agreement and the Licensee must settle the invoice within [***] of receipt.

 

8.2Subject to clause 8.3, the Licensee will pay to OUI a royalty equal to the applicable Royalty Rate on all Net Sales of Licensed Products for the duration of the agreement on the terms set out in clause 10.

 

8.3Following expiration or revocation of the last Valid Claim covering a Licensed Product in a country in which the Licensed Product is Marketed and where there is being Marketed and sold by a third party in the normal course of business a product that, directly or indirectly, competes with the Licensed Product, the Step Down Rate (as defined below) shall apply on a country-by-country basis to the applicable Royalty Rate of such Licensed Products. For the purposes of this clause 8.3, the “Step Down Rate” shall be the percentage decrease of (a) [***] compared against (b) [***].

 

8.4In the event that the royalties paid to OUI under clause 8.2 does not amount to at least the Minimum Sum, the Licensee must make up the difference between the royalties paid under clauses 8.2 and the Minimum Sum in each Licence Year where a Minimum Sum applies.

 

8.5The Licensee will notify OUI as soon as possible after it or any sub-licensee achieves any Milestone, and pay to OUI the Milestone Fee in respect of each Milestone within [***] of the date on which each Milestone is achieved by the Licensee or a sub-licensee.

 

8.6The Licensee will pay to OUI a royalty equal to the Fee Income Royalty Rate on any sublicensing fees that the Licensee receives for sublicensing the Licensed Technology with a third party. For the purposes of this clause 8.6, Sublicensing fees shall include upfront fees, milestone payments and other consideration received by the Licensee from such third party but shall exclude:

 

(a)royalties paid to the Licensee by a sub-licensee based on net sales of Licensed Products;

 

(b)milestone payments paid to the Licensee by a sub-licensee on a Milestone event; and

 

(c)any sums received that are to be used to fund research and/or development.

 

8.7If the Licensee has to pay royalties to a third party (other than an Affiliate), for the right to make, have made, use or Market a Licensed Product, under a licence of Intellectual Property Rights without which the Licensed Technology cannot lawfully be exploited, then the Licensee will be entitled to deduct from all royalty payments due to OUI in respect of Net Sales of the Licensed Product under clause 8.2 an amount equal to [***] of the royalties actually paid to that third party, up to a maximum amount of [***] of the royalties due to OUI under clause 8.2.

 

8.8Where a Licensed Product is sold as part of a combination product or co-packaged product, the Net Sales from the combination product or the co-packaged product, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales of the combination product or the co-packaged product, during the applicable royalty reporting period, by the fraction:

 

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[***]

 

Where A is the average sale price of the Licensed Product when sold separately in finished form, or if not sold separately, the market price of the Licensed Product if it were sold separately and B is the average sale price of the other product(s) included in the combination product or co-packaged product when sold separately in finished form, or if not sold separately, the aggregate market price of the other product(s) if it were sold separately in each case during the applicable royalty reporting period or, if sales of both the Licensed Product and the other product(s) did not occur in such period, then in the most recent royalty reporting period in which sales of both occurred. In the event that such average sale price cannot be determined for the Licensed Product and any other product(s) included in the combination product or co-packaged product, then the Net Sales for the purposes of determining royalty payments for a combination product or a co-packaged product shall be referred to an independent expert for determination.

 

8.9The Signing Fee and the Milestone Fee are non-refundable and will not be considered as an advance payment on royalties payable under clause 8.2. No part of the Minimum Sum will be refundable or applicable to succeeding Licence Years.

 

8.10Licensed Products supplied for use in any clinical trial carried out by or on behalf of the Licensee or any of its sub-licensees shall not be deemed to be sales and shall not be included within any Net Sales calculation.

 

8.11The Licensee or any of its sub-licensees may supply a commercially reasonable quantity of Licensed Products for promotional sampling provided that after Licensee commences commercial supply of Licensed Product, the number of Licensed Products supplied for promotional sampling shall not be greater than [***] of the total number of units of each Licensed Product sold leased or licensed by the Licensee in any Quarter following the Licensee receiving Marketing Authorization for the Licensed Product in any territory. Except as set out in this clause, the Licensee must not accept any non-monetary consideration when Marketing the Licensed Products or when issuing sub-licences of the Licensed Technology without the prior written consent of OUI, such consent not to be unreasonably withheld, conditioned or delayed. The Licensee may accept non-monetary consideration when Marketing the Licensed Products or when issuing sub-licences of the Licensed Technology provided either (a) [***] of such non-monetary consideration is able to be converted into cash within [***] of receipt from the Licensee to enable the Fee Income Royalty Rate to be paid to OUI in cash or (b) the Licensee covenants in writing to pay to OUI in cash, within [***] of receipt of the non-monetary consideration, the Fee Income Royalty Rate due to OUI.

 

8.12The Licensee will make all payments in pounds sterling or any currency replacing pounds sterling in its entirety.

 

8.13For the purposes of calculating any amount payable by the Licensee to OUI in a currency other than pounds sterling (or replacement currency), the Licensee shall apply an exchange rate equivalent to:

 

(a)the average of the applicable closing mid rates quoted by the Financial Times as published in London on the first Business Day of each month during the Quarter just closed; or

 

(b)for payments under clause 8.6 only, the first Business Day of the month in which the payment was received by the Licensee.

 

8.14Where the Licensee has to withhold tax by law, the Licensee will deduct the tax, pay it to the relevant taxing authority, and supply OUI with a Certificate of Tax Deduction at the time of payment to OUI. Where such an issue arises, the Licensee will not be liable for any costs or penalties associated with late payment to OUI provided that the Licensee takes reasonable steps to ensure that any such matters are dealt with as expeditiously as reasonably possible.

 

8.15In the event that full payment of any amount due from the Licensee to OUI under this agreement is not made by any of the dates stipulated, the Licensee shall be liable to pay interest on the amount unpaid at the rate of [***] per annum over the base rate for the time being of Barclays Bank plc. Such interest shall accrue on a daily basis from the date when payment was due until the date of actual payment of the overdue amount, whether before or after judgment, and shall be compounded quarterly.

 

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8.16If the Licensed Product is of a description covered by the Medicines Access Policy, the Licensee shall adhere to the requirements of the Medicines Access Policy. In particular in the event the Licensed Products can be used to ease the burden of illness in the developing world, the Marketing of Licensed Products will be managed in a manner that enables availability and accessibility at reasonable cost to the people most In need in the developing world.

 

9.Commercially Reasonable Endeavours

 

9.1Subject to clause 9.3, the Licensee must use Commercially Reasonable Endeavours to develop, exploit and Market the Licensed Technology to maximize the financial return for both parties.

 

9.2Subject to clause 9.3, the Licensee must use Commercially Reasonable Endeavours to develop, exploit and Market the Licensed Technology in accordance with the Development Plan as set out separately In respect of each Indication.

 

9.3The Licensee will deliver to OUI at least [***] prior to the commencement of each subsequent Licence Year a revised development plan for the intended development of a Licensed Product for each Indication together with any background supporting information necessary for OUI to evaluate the draft plan. The Licensee will consult with OUI over the draft plan and will consider in good faith any comments that OUI may put forward. Following approval of the revised development plan by OUI, the revised development plan shall become the Development Plan.

 

9.4The Licensee may give written notice to OUI that it no longer intends to develop, exploit and Market a Licensed Product in an Indication and following that notice:

 

9.4.1the Licensee will no longer have obligations to use Commercially Reasonable Endeavours to develop, exploit and Market a Licensed Product in that Indication; and

 

9.4.2without prejudice to any and all of its existing rights under this agreement, the Licensee will no longer have any rights to use the Licensed Technology in relation to that Indication.

 

10.Royalty Reports and Audit

 

10.1The Licensee will provide OUI with a report at least once in every [***] detailing the activities and achievements in its development of the Licensed Technology in order to facilitate its commercial exploitation, and in the development of potential Licensed Products.

 

10.2The Licensee will provide OUI with a royalty report within [***] after the close of each Quarter for each Licensed Product Marketed by the Licensee and its sub-licensees. Each Royalty Report will:

 

(a)set out the Net Sales of each Licensed Product Marketed by the Licensee, and any sub-licensees including the total gross selling price of each Licensed Product Marketed by the Licensee and any sub-licensees and the quantity or total number of units of each Licensed Product Marketed by the Licensee and any sub-licensees;

 

(b)set out details of deductions made in the calculation of Net Sales from the invoiced price of each Licensed Product in the form in which it is Marketed by the Licensee or any sub-licensees;

 

(c)set out details of the quantity of Licensed Products used for promotional sampling by the Licensee or any sub-licensees;

 

(d)provide a calculation of the royalties due;

 

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(e)set out details of payments received by the Licensee to which the Fee Income Royalty Rate applies and provide a calculation of the royalties due from the Licensee to be paid under the Fee Income Royalty Rate;

 

(f)provide a statement showing whether or not royalties due exceed the Minimum Sum and, if so, by how much;

 

(g)set out details of Milestones achieved by the Licensee or any sub-licensees; and

 

(h)set out the steps taken during the Licence Year to promote and Market Licensed Products.

 

The Licensee must pay OUI the royalties due in respect of the Quarter just closed at the same time as the Licensee delivers the Royalty Report provided that, if requested, OUI will issue an invoice for the relevant payment prior to payment.

 

10.3The Licensee will deliver to OUI a periodic report at the close of each Licence Year providing sufficient data (in outline form) to give a reasonable indication or estimate of the actual or expected market share of the Licensee and its sub-licensees and will notify OUI in the event that its market share does or is expected to breach the limits set out in the 2014 Commission Regulation 316/2014 Technology Transfer Block Exemption Regulation and Guidelines in Commission Communication 2014/C 89/03 and any successor regulation. This obligation is not intended to place a significant additional financial burden on the Licensee.

 

10.4If a Licensed Product Marketed by the Licensee is re-Marketed by an Affiliate or an entity over which the Licensee exercises Control, the royalty on each such Licensed Product will be calculated on the highest of the prices at which it is Marketed or re-Marketed. For the avoidance of doubt, when a Licensed Product is sold to an arm’s length distributor then Net Sales is calculated on the transfer price paid by the distributor to the Licensee.

 

10.5The Licensee must keep complete and proper records and accurate accounts of all Licensed Products used and Marketed by the Licensee and any sub-licensee in each Licence Year for at least [***]. OUI may, through an independent certified accountant appointed by OUI (“the Auditor”), audit all such accounts on at least [***] written notice no more than once each Licence Year for the purpose of determining the accuracy of the Royalty Reports and payments. The Auditor shall be:

 

10.5.1permitted by the Licensee to enter the Licensee’s principal place of business upon reasonable notice to inspect such records and accounts;

 

10.5.2entitled to take copies of or extracts from such records and accounts as are strictly necessary for the Auditor to properly conduct the audit;

 

10.5.3given all other information by the Licensee as may be necessary or appropriate to enable the amount of royalties payable to be ascertained including the provision of relevant records; and

 

10.5.4shall be allowed access to and permitted to conduct interviews of any sales, engineering or other staff of the Licensee in order to verify the accuracy of the records and accounts and the accuracy of any statements provided to OUI under clause 10.2.

 

If on any such audit a shortfall in payments of greater than [***] is discovered by the Auditor in respect of the audit period, the Licensee shall pay OUI’s audit costs.

 

10.6The Licensee will ensure that equivalent obligations and access rights, as set out in clause 10.5, allowing OUI auditing rights to the sub-licensee are included in each sub-licence agreement.

 

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11.Duration and Termination

 

11.1This agreement will take effect on the date of signature. Subject to the possibility of earlier termination under the following provisions of this clause 11, and subject to the possibility of an extension to the term by mutual agreement, this agreement shall continue in force:

 

(a)until the expiry of the last Valid Claim anywhere in the world; and

 

(b)in any event for twenty (20) years from the date of this agreement.

 

11.2If either party commits a material breach of this agreement, and the breach is not remediable or (being remediable) is not remedied within the period allowed by notice given by the other party in writing calling on the party in breach to effect such remedy (such period being not less than [***]), the other party may terminate this agreement by written notice having immediate effect.

 

11.3The Licensee may terminate this agreement for any reason at any time provided it gives OUI [***] written notice to terminate expiring after the third anniversary of this agreement whereupon the Licensee shall bring all sub-licences to an end on the same date. Any such termination shall not absolve the Licensee of its obligation to accrue and pay royalties and other payments under the provisions of clause 8 in respect of the period prior to termination.

 

11.4OUI may terminate this agreement:

 

(a)immediately, if the Licensee has a petition presented for its winding-up (but excluding for this purpose any winding up petition presented against the Licensee in relation to any debt disputed by the Licensee), or passes a resolution for voluntary winding-up otherwise than for the purposes of a bona fide amalgamation or reconstruction, or compounds with its creditors, or has a receiver administrator or administrative receiver appointed of all or any part of its assets, or enters into any arrangements with creditors, or takes or suffers any similar action in consequence of debts;

 

(b)on [***] written notice if:

 

(i)the Licensee opposes or challenges the validity of any of the Applications or raises the claim that the Licensed Know-how is not necessary to develop and Market Licensed Products, provided always that nothing in this clause 11.4(b) will prevent the Licensee from seeking to determine whether a product of the Licensee is a Licensed Product for the purposes of this agreement; or

 

(ii)the Licensee is in breach of clause 9.1 and the Licensee does not take any remedial action reasonably requested by OUI and notified to the Licensee by written notice pursuant to clause 11.2.

 

11.5On termination or expiration of this agreement, for whatever reason, the Licensee:

 

(a)must bring all sub-licences to an end on the same date;

 

(b)shall pay to OUI all outstanding royalties and other sums due under this agreement;

 

(c)shall provide OUI with details of the stocks of Licensed Products held at the point of termination;

 

(d)must cease to use or exploit the Licensed Technology, provided that this restriction does not apply to Licensed Know-How or Confidential Information which has entered the public domain through no fault of the Licensee, and that the Licensee may continue to use the Licensed Technology in order to meet any specific existing binding commitments already made by the Licensee at the date of termination and requiring delivery of Licensed Products within the next [***];

 

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(e)must, at the option of OUI and at the Licensee’s cost, destroy all other Licensed Products or send all other Licensed Products to a location nominated by OUI to the Licensee in writing;

 

(f)grants OUI an irrevocable, transferable, non-exclusive licence to develop, make, have made, use and Market the Licensee’s Improvements and products that incorporate, embody or otherwise exploit the same. OUI shall pay a reasonable royalty for use of this licence unless the termination arises under clause 11.4, or is terminated by OUI under clause 11.2, in which case it shall be royalty-free.

 

11.6Termination of this agreement, whether for breach of this agreement or otherwise, shall not absolve the Licensee of its obligation to accrue and pay royalties under the provisions of clause 8 for the duration of any notice period and in respect of any dealings in Licensed Products permitted by clause 11.5.

 

11.7Clauses 1, 4.2, 6.3, 11.5, 11.7, 11.8, 12, 13.4 and 13.14 will survive the termination or expiration of this agreement, for whatever reason, [***].

 

11.8Clauses 7 and 10.5 will survive the termination or expiration of this agreement, for whatever reason, [***].

 

12.Liability

 

12.1Subject to Clause 12.2 and to the fullest extent permissible by law, OUI does not make any warranties of any kind including, without limitation, warranties with respect to:

 

(a)the quality of the Licensed Technology;

 

(b)the suitability of the Licensed Technology for any particular use;

 

(c)whether use of the Licensed Technology will infringe third-party rights; or

 

(d)whether the Applications will be granted or the validity of any patent that issues in response to the Applications.

 

12.2OUI warrants to the Licensee that so far as OUI is aware (not having made any specific enquiries) as at the date of this agreement:

 

12.2.1OUI has the necessary corporate power and authority to enter into this agreement and to grant the licences set out in this agreement to the Licensee;

 

12.2.2with the exception of the licence back to the University for Non-Commercial Use, the University has assigned all of its right, title and interest in the Licensed Technology to OUI;

 

12.2.3it has not created any charge or mortgage over the Licensed Technology;

 

12.2.4it has not created any licence over Application 1 or Application 2; and

 

12.2.5there is no actual or threatened infringement of the Licensed Technology by any third party.

 

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12.3Except in relation to any claims, damages and liabilities arising directly from (i) a breach of this agreement by OUI, and/or (ii) the fraud, negligence or wilful misconduct of OUI or the University, the Licensee agrees to indemnify OUI and the University and hold OUI and the University harmless from and against any and all claims, damages and liabilities:

 

(a)asserted by third parties (including claims for negligence) which arise from the use of the Licensed Technology or the Marketing of Licensed Products by the Licensee and/or its sub-licensees; and/or

 

(b)arising directly from any breach by the Licensee of this agreement provided however that this indemnity for breach by the Licensee is subject to clause 12.6.

 

12.4OUI will use reasonable endeavours to defend any Indemnified Claim and to mitigate its losses, claims, liabilities, costs, charges and expenses or (at OUI’s option) allow the Licensee to do so on its behalf (subject to the University retaining the right to be kept informed of progress in the action and to have reasonable input into its conduct). OUI will not (except as required by law) make any admission, compromise, settlement or discharge of any Indemnified Claim without the consent of the Licensee (which will not be unreasonably withheld or delayed).

 

12.5The Licensee undertakes to make no claim against any employee, student, agent or appointee of OUI or of the University, being a claim which seeks to enforce against any of them any liability whatsoever in connection with this agreement or its subject-matter.

 

12.6Subject to clause 12.8 and except in relation to the indemnities in clause 6.3 and 12.3(a), the liability of either party for any breach of this agreement, in negligence or arising in any other way out of the subject-matter of this agreement, will not extend to incidental, indirect or consequential damages or loss of profits.

 

12.7Subject to clause 12.8 the liability of OUI to the Licensee accruing in any Licence Year under or otherwise in connection with this agreement or its subject-matter, including without limitation liability for negligence, shall in no event exceed:

 

(a)in respect of liability accruing in the first Licence Year, the amount of the Signing Fee paid to OUI; and

 

(b)in respect of liability accruing in any subsequent Licence Year, the total royalties paid in the previous Licence Year to OUI under clause 8.2.

 

12.8Nothing in this agreement shall limit or exclude any liability for fraud or fraudulent misrepresentation or death, or personal injury or any other liability which may not, by law, be excluded.

 

12.9Notwithstanding any other clause in this agreement, OUI shall not be entitled to profit from any grant of a licence to any third party in respect of the Licensed Technology that breaches the exclusive rights granted to the Licensee under clause 2.1.1(a) of this agreement (“a Licence to the Exclusive Rights”). In the event that the Licensee (acting in good faith) believes that OUI has granted a Licence to the Exclusive Rights, then the Licensee shall provide written notice to OUI with full particulars and all evidence supporting the Licensee’s basis for such belief. Within [***] of receipt of written notice from the Licensee, OUI will notify the Licensee in writing whether it admits or disputes that It has granted a Licence to the Exclusive Rights. If OUI serves notice that it disputes that it has granted a Licence to the Exclusive Rights OUI and the Licensee shall enter into good faith negotiations in order to reach mutual agreement to resolve the dispute and if such mutual agreement is not reached within [***] after OUI’s receipt of the Licensee’s written notice, then the parties will refer the dispute to an independent expert (“Independent Expert”) for determination on the following basis:

 

12.9.1the Independent Expert shall be agreed on by the parties, or, if agreement is not reached within [***] of either party giving notice to the other that it wishes to refer a matter to an Independent Expert, the Independent Expert may be nominated by the President of the Law Society of England and Wales on the request of either party;

 

12.9.2the Independent Expert shall be asked to determine:

 

12.9.2.1whether OUI has granted a Licence to the Exclusive Rights; and

 

12.9.2.2any dispute between the parties over the amount of consideration paid to OUI under any Licence to the Exclusive Rights;

 

12

 

 

12.9.3the Independent Expert shall act as an expert and not as an arbitrator;

 

12.9.4the Independent Expert’s decision shall be final and binding on the parties in the absence of fraud or manifest error; and

 

12.9.5each party shall bear its own costs in relation to the reference to the Independent Expert. The Independent Expert’s fees and any costs it properly incurs in arriving at its determination (including any fees and costs of any advisers appointed by the Independent Expert) shall be borne by the parties in equal shares or in such proportions as the Independent Expert may direct.

 

12.10In the event that OUI has admitted or the Independent Expert has determined that OUI has granted a Licence to the Exclusive Rights then OUI will pay to the Licensee a sum equal to all consideration paid to OUI under the Licence to the Exclusive Rights (including consideration that is not in the form of cash payments where it is possible to put a cash value on such a payment). OUI will pay that sum to the Licensee as soon as possible and in any event no later than [***] following the date of admission by OUI or the Independent Expert’s determination and will continue to pay a sum equal to all further consideration received by OUI under any such Licence to the Exclusive Rights no later than [***] after receipt. The parties agree that the payment of such sums to the Licensee represent the full amount of compensation to which the Licensee is entitled and the extent of OUI’s liability to the Licensee for any grant by OUI of a Licence to the Exclusive Rights.

 

13.General

 

13.1Registration - The Licensee must register its interest in the Licensed Technology with any relevant authorities in the Territory as soon as legally possible. The Licensee must not, however, register an entire copy of this agreement in any part of the Territory or disclose its financial terms without the prior written consent of OUI (such consent not to be unreasonably withheld or delayed).

 

13.2Advertising - The Licensee must not use the name of OUI, the University or the Inventors (except those Inventors who are, or have at any time been, shareholders of the Licensee) in any advertising, promotional or sales literature, without OUI’s prior written approval (such consent not to be unreasonably withheld or delayed).

 

13.3Packaging - The Licensee will ensure that the Licensed Products and the packaging associated with them are marked suitably with any relevant patent or patent application numbers to satisfy the laws of each of the countries in which the Licensed Products are sold or supplied and in which they are covered by the claims of any patent or patent application, to the intent that OUI shall not suffer any loss or any loss of damages in an infringement action.

 

13.4Thesis - This agreement shall not prevent or hinder registered students of the University from submitting for degrees of the University theses based on the Licensed Technology; or from following the University’s procedures for examinations and for admission to postgraduate degree status.

 

13.5Taxes - Where the Licensee has to make a payment to OUI under this agreement which attracts value-added, sales, use, excise or other similar taxes or duties, the Licensee will be responsible for paying those taxes and duties.

 

13.6Notices - All notices to be sent to OUI under this agreement must indicate the OUI Project N° and should be sent, by post and fax unless agreed otherwise in writing, until further notice to: The Chief Operating Officer, OUI Innovation Ltd, Buxton Court, 3 West Way, Oxford OX2 OSZ, Fax: +44 (0)1865 280831. All notices to be sent to the Licensee under this agreement should be sent, until further notice, to the Licensee’s Contact and Address indicating the OUI Project No.

 

13

 

 

13.7Force Majeure - If performance by either party of any of its obligations under this agreement (not including an obligation to make payment) is prevented by circumstances beyond its reasonable control, that party will be excused from performance of that obligation for the duration of the relevant event.

 

13.8Assignment - The Licensee may assign any of its rights or obligations under this agreement in whole or in part to an Affiliate but only for so long as it remains an Affiliate and OUI shall at the request of the Licensee execute a deed of novation to bring about that assignment. Except as provided in this clause, the Licensee may not assign any of its rights or obligations under this agreement without the prior written consent of OUI (such consent not to be unreasonably withheld, delayed or conditioned except solely on the grounds that primarily relate to avoiding any detrimental reputational impact on the University or the assignee having insufficient funds to fulfil the obligations of this agreement, it being acknowledged and agreed that if the assignee is a publicly-listed company with a market capitalisation equal to or in excess of [***] it will be considered to have sufficient financial resources to develop and Market the Licensed Product). If OUI assigns Its rights in the Licensed Technology to any person it shall do so expressly subject to the Licensee’s rights under this agreement.

 

13.9Severability - If any of the provisions of this agreement is or becomes invalid, illegal or unenforceable, the validity, legality or enforceability of the remaining provisions will not in any way be affected or impaired. The parties will, however, negotiate to agree the terms of a mutually satisfactory provision, achieving as nearly as possible the same commercial effect, to be substituted for the provision found to be void or unenforceable.

 

13.10No Partnership etc - Nothing in this agreement creates, implies or evidences any partnership or joint venture between OUI and the Licensee or the relationship between them of principal and agent.

 

13.11Entire Agreement - This agreement constitutes the entire agreement between the parties in relation to the Licence to the exclusion of all other terms and conditions (including any terms or conditions which the Licensee purports to apply under any purchase order, confirmation order, specification or other document). The Licensee has not relied on any other statements or representations in agreeing to enter this agreement and waives all claims for breach of any warranty and all claims for any misrepresentation (negligent or of any other kind, unless made by OUI fraudulently) in relation to any representation which is not specifically set out in this agreement. Specifically, but without limitation, this agreement does not impose or imply any obligation on OUI or the University to conduct development work. Any arrangements for such work must be the subject of a separate agreement between the University and the Licensee.

 

13.12Variation - Any variation of this agreement must be in writing and signed by authorised signatories for both parties. For the avoidance of doubt, the parties to this agreement may rescind or vary this agreement without the consent of any party that has the benefit of clause 13.14.

 

13.13Waiver - No failure or delay by either party in enforcing its rights under this agreement, or at law or in equity will prejudice or restrict those rights. No waiver of any right will operate as a waiver of any other or later right or breach. Except as stated to the contrary in this agreement, no right, power or remedy conferred on, or reserved to, either party is exclusive of any other right, power or remedy available to it, and each of those rights, powers, and remedies is cumulative.

 

13.14Rights of Third Parties - The parties to this agreement intend that by virtue of the Contracts (Rights of Third Parties) Act 1999 the University and the people referred to in clause 12.5 will be able to enforce the terms of this agreement intended by the parties to be for their benefit as if the University and the people referred to in clause 12.5 were party to this agreement.

 

13.15Governing Law - This agreement is governed by English Law, and the parties submit to the exclusive jurisdiction of the English Courts for the resolution of any dispute which may arise out of or in connection with this agreement except in relation to any action in relation to Intellectual Property Rights or Confidential Information which may be brought in any court of competent jurisdiction.

 

14

 

 

Schedule 1

 

DEFINITIONS
(Clause 1)

 

Academic and Research Purposes means research, teaching or other scholarly use which is undertaken for the purposes of education and research.

 

Affiliate means any company or legal entity in any country Controlling or Controlled by the Licensee (or any legal entity in a country Controlling or Controlled by the sub-licensee).

 

AIN means anal intraepithelial neoplasia.

 

Applications means:

 

(a)the patent applications set out as Applications 1, 2, 3,4 and 5 in Schedule 2;
   
(b)any patents granted in response to those applications;
   
(c)any corresponding foreign patents and applications which may be granted to OUI in the Territory based on and deriving priority from those applications; and
   
(d)any addition, continuation, continuation-in-part, division, reissue, renewal or extension based on the applications.

 

Business Day means a day, other than a Saturday or Sunday, on which clearing banks are permitted to open in London.

 

CIN means cervical intraepithelial neoplasia.

 

Clinical Patient Care means diagnosing, treating and/or managing the health of persons under the care of an individual having the right to use the Licensed Technology for Academic and Research Purposes in the event that such Licensed Technology is capable of application in a healthcare setting without further development.

 

Commercially Reasonable Endeavours means, in respect of each Indication to be developed separately, the effort a prudent and determined company of comparable size and sector to the Licensee would take to pursue the goal of developing and Marketing Licensed Products to maximize the financial return and in any event do no less than is required to fulfil the steps laid out in the Development Plan.

 

Confidential Information means in relation to each party any materials, trade secrets or other information disclosed by that party to the other, including, without limitation:

 

(a)the Licensed Technology, to the extent that it Is not disclosed by the Application when published; and

 

(b)this agreement.

 

Control means:

 

(a)ownership of more than fifty percent (50%) of the voting share capital of the relevant entity; or

 

(b)the ability to direct the casting of more than fifty percent (50%) of the votes exercisable at a general meeting of the relevant entity on all, or substantially all, matters.

 

Development Plan means the plan set out in Schedule 3 as revised in accordance with clause 9.3.

 

Documents means the documents and materials set out in Schedule 4.

 

Fee Income Royalty Rate means the fee income royalty rate set out in Schedule 2.

 

15

 

 

HBV means hepatitis B virus.

 

HPV means human papilloma virus.

 

Improvement means any development of the Licensed Technology which would, if commercially practised, infringe and/or be covered by a claim subsisting or being prosecuted in an Application.

 

Indication means Hepatitis B Virus therapy and Human Papilloma Virus associated diseases.

 

Indemnified Claim means any claim under which OUI and the University are entitled to be indemnified under clause 12.3.

 

Intellectual Property Rights means patents, trade marks, copyrights, database rights, rights in designs, and all or any other intellectual or industrial property rights, whether or not registered or capable of registration.

 

Inventor means the inventor or inventors named in the Applications and identified in Schedule 2.

 

Inventor Improvements means any Improvements to Application 1 or Application 2 made prior to [***] solely by the Inventor, and the Intellectual Property Rights pertaining to them, of which OUI has been made aware and is legally able to license but shall not include, for the avoidance of doubt, any Improvements and Intellectual Property Rights developed pursuant to any employment or consultancy arrangements with Licensee or its Affiliates.

 

Legal Action means commencing or defending any proceedings before a court or tribunal in any jurisdiction in relation to any rights included in the Licensed Technology including all claims and counterclaims for infringement and for declarations of non-infringement or invalidity.

 

Licence means the licence granted by OUI to the Licensee under clause 2.1.

 

Licensed Intellectual Property Rights means the Applications and (to the extent they constitute Intellectual Property Rights) the Inventor’s Improvements.

 

Licensed Know-how means all confidential information relating to an Application that has been communicated to the Licensee by OUI in writing before the date of this agreement or is communicated in writing to the Licensee by OUI under this agreement and within [***] after the date of this agreement and (to the extent they constitute confidential information) OUI’s Improvements.

 

Licensed Product means any product, process, service or composition which is entirely or partially produced by means of or with the use of, or within the scope of, the Licensed Technology, or any of it.

 

Licensed Technology means the Licensed Intellectual Property Rights and the Licensed Know-How, and such (if any) other Intellectual Property Rights owned by or licensed to OUI as may be specifically identified in Schedule 2 (to the extent, in the case of licensed rights, that OUI is legally able to grant a sub-licence of the same).

 

Licensee’s Contact and Address means the address for the Licensee set out in Schedule 2 of this agreement.

 

Licensee Improvements means any Improvements made prior to the second anniversary of the date of this agreement by the Licensee, and the Intellectual Property Rights pertaining to them, which shall include, for the avoidance of doubt, any Improvements and Intellectual Property Rights developed by an Inventor pursuant to research collaboration arrangement with the Licensee.

 

Licence Year means each [***] period beginning on the date of this agreement and each anniversary of the date of this agreement.

 

Market means, in relation to a Licensed Product, offering to sell, lease, licence or otherwise commercially exploit the Licensed Product or the sale, lease, licence or other commercial exploitation of the Licensed Product.

 

16

 

 

Medicines Access Policy means the policy of the University to promote access to pharmaceutical and other products and services, the current version of which is available at www.admin.ox.ac.uk/researchsupport/integrity/access.

 

Milestone and Milestone Fee means the milestones, and the amounts payable on achievement of each of the milestones, set out in Schedule 2.

 

Minimum Sum means the minimum sum or sums set out in Schedule 2.

 

Net Sales means the gross selling price of the Licensed Product in the form in which it is Marketed by the Licensee or any sub-licensee, less:

 

(a)trade, and/or quantity discounts, returns, allowances, in amounts customary in the trade and actually given; and
   
(b)import, export, excise, sales or use taxes, value added taxes and other taxes, tariffs or duties to the extent such items are included in the gross invoice price and actually paid; and
   
(c)freight, handling, transportation and insurance prepaid or allowed if separately identified in such invoice and actually paid; and
   
(d)amounts allowed or credited or retroactive price reductions or rebates and actually given/paid.

 

Any refund of any of the foregoing amounts previously deducted from Net Sales shall be appropriately credited upon receipt.

 

The Licensee may, at its option, allocate the above deductions from sales of Licensed Products based upon accruals estimated reasonably and consistently with the Licensee’s standard business practices. If the Licensee elects to utilise such accruals, actual deductions will be calculated and, if applicable, a “true-up” made, on an annual basis.

 

A transfer of a Licensed Product from Licensee to an Affiliate or from a sub-licensee to an Affiliate of a sub-licensee shall not be deemed to be a sale hereunder, provided that If a sale of a Licensed Product is to an Affiliate of the Licensee or of the sub-licensee and such Affiliate is the end user of the Licensed Product, then the “gross selling price” with respect to such sale shall, for the purposes of calculating “Net Sales” be the greater of (a) the actual amount invoiced and (b) the amount which the invoiced amount would have been had such sale of the Licensed Product been to a person at arm’s length of the Licensee or sub-licensee.

 

Non-Commercial Use means Academic and Research Purposes and the purposes of Clinical Patient Care. This includes the right for the University to license the Licensed Technology to any of its collaborators in connection with and solely for the University’s Academic and Research Purposes; but it does not include the right to commercially exploit the Licensed Technology or grant any license to commercially exploit the Licensed Technology.

 

Marketing Authorisation means a marketing authorization granted by a regulatory authority such as the Food and Drug Administration or European Medicines Agency necessary to Market a Licensed Product in a given country.

 

Past Patent Costs means the past patent costs set out in Schedule 2.

 

Project means the projects referred to in BACKGROUND.

 

Quarter means each period of three calendar months during a Licence Year with the first Quarter commencing on the first day of each Licence Year.

 

Royalty Rate means the royalty rate or rates set out in Schedule 2 on Net Sales of Licensed Products for, as applicable, Hepatitis B therapy and/or Human Papilloma Virus associated diseases.

 

Royalty Report means the report to be prepared by the Licensee under clause 10.2.

 

17

 

 

Signing Fee means the signing fee set out in Schedule 2.

 

Territory means the territory or territories set out in Schedule 2, excluding any territory or territories removed through the operation of clause 5.5.

 

University means the Chancellor, Masters and Scholars of the University of Oxford whose administrative offices are at the University Offices, Wellington Square, Oxford OX1 2JD.

 

Valid Claim means a granted or currently pending patent claim included in the Licensed Intellectual Property Rights that has not expired nor been held permanently revoked, unpatentable, invalid or unenforceable by a court or tribunal of competent jurisdiction in a final and non-appealable judgment; nor been rendered unenforceable through disclaimer or otherwise abandoned.

 

Schedule 2

 

Application 1:  UK Patent Application number [***];
    
Application 2:  UK Patent Application number [***];
    
Application 3:  European patent application number [***]; and
    
Application 4:  International patent application number [***].
    
Application 5:  International patent application number [***]

 

Inventor:   Application 1:   [***]
    Application 2:   [***]
    Application 3:   [***]
    Application 4:   [***]
    Application 5:   [***]

 

Territory (clause 2.1):   Worldwide
 
Past Patent Costs (clause 5.1):   [***]
 
Signing Fee (clause 8.1):   [***]
 
Royalty Rate (clause 8.2):
 
    [***] Net Sales on Licensed Products for Hepatitis B therapy
 
    [***] Net Sales on any Licensed Products for CIN1/2+ (CIN1, CIN2 & CIN3), AIN & HPV pre-cancerous neoplasias
 
    [***] Net Sales on any Licensed Products for HPV-related cancers
 

Minimum Sum (clause 8.4):

 

    Licence Year Minimum Sum  
    4 [***]  
    5 [***]  
    6 and each year thereafter [***]  

 

Fee Income Royalty Rate (clause 8.6):

 

[***] where the sublicensing or partnering arrangement takes place during the first three Licence Years

 

[***] where the sublicensing or partnering arrangement takes place after the third Licence Year

 

Milestone and Milestone Fee (clause):

 

Licensed Product for Hepatitis B therapy:

 

Milestone Milestone Fee
Successful completion of phase II trial [***]
Initiation of phase III trial [***]
Marketing authorisation & pricing & reimbursement approval in first major territory [***]
Marketing authorisation & pricing & reimbursement approval in second major territory [***]
First calendar year in which annual Net Sales of Licensed Product exceed [***] [***]

 

18

 

 

Licensed Product for Human Papilloma Virus associated diseases:

 

Milestone Milestone Fee
Successful completion of first phase II trial for CIN [***]
Initiation of first phase III trial for CIN [***]
Initiation of first phase III trial for cancer [***]
First marketing authorisation & pricing & reimbursement approval for CIN [***]
First marketing authorisation & pricing & reimbursement approval for cancer [***]
First calendar year in which annual Net Sales of Licensed Product for any HPV associated diseases exceed [***] [***]

 

For the purposes of these Milestones:

 

“Successful completion” of trials means the trial meets its primary endpoints and that the results justify commercial and scientific progression to the next stage of trial.

 

“Initiation” of new trials means the first administration of the trial drug in the first study subject recruited in accordance with the approved study protocol.

 

Licensee’s Contact and Address (clause 13.6):

 

    Contact Dr Tom Evans  
    Address

Oxford Sciences Innovation

King Charles House,

Park End Street,

Oxford, 0X11JD

 
    Email [***]  

 

19

 

 

Schedule 3

 

DEVELOPMENT PLAN

 

[***]

 

[***]

 

20

 

 

Schedule 4

 

DOCUMENTS

 

[***]

 

[***]

 

21

 

 

Schedule 5

 

DEED OF COVENANT

 

Oxford University Innovation Limited
University Offices,
Wellington Square,
Oxford 0X1 2JD,
England

 

Date: [insert date]

 

Dear Sirs,

 

Sub-Licence between Vaccitech Limited (“Vaccitech”) and [insert details of Sub-Licensee] dated [insert date] (the “Sub-Licence”)

 

As part consideration for the grant of a sub-licence from Vaccitech to use [insert details of licensed technology] (the “Licensed Technology”), the Sub-Licensee hereby covenant to Oxford University Innovation Limited (OUI) and OUI covenant with the Sub-Licensee that:

 

1.should the head licence between Vaccitech and OUI be terminated for whatever reason, OUI and the Sub-Licensee shall enter into a direct licence containing the same obligations and liabilities as set forth in the Sub-Licence and the Sub-Licensee will pay all due and payable under the Sub-Licence to OUI;

 

2.should the Sub-Licensee wish to further sub-licence the Licensed Technology where OUI has consented to the Sub-Licence including the right to do so, it shall procure that any sub-sub-licensee enters into a Deed of Covenant with OUI in a form substantially similar to this Deed of Covenant;

 

3.OUI shall have the right, during the term of the Sub-Licence, through an independent certified accountant appointed by OUI (the “Auditor”), to audit all accounts on at least [***] written notice no more than once each calendar year for the purpose of determining the accuracy of the royalty reports and payments. The Auditor shall be:

 

a.permitted to enter the principal place of business of the Sub-Licensee upon reasonable notice to inspect such records and accounts;

 

b.entitled to take copies of or extracts from such records and accounts;

 

c.given all other information by the Sub-Licensee as may be necessary or appropriate to enable the amount of royalties payable to be ascertained including the provision of relevant records; and

 

d.shall be allowed access to and permitted to conduct interviews of any sales, engineering or other staff of the Sub-Licensee in order to verify the accuracy of the records and accounts and the accuracy of any royalty statements provided to Vaccitech.

 

If on any such audit a shortfall in payments of greater than [***] is discovered by the Auditor in respect of the audit period, the Sub-Licensee shall pay the audit costs of OUI.

 

22

 

 

SIGNED AS A DEED by
[Insert details of Sub-Licensee] in the presence of:-

 

Signature of Witness:

 

Name of Witness:
Address:

 

SIGNED AS A DEED by
OXFORD UNIVERSITY INNOVATION LIMITED in the presence of:-

 

Signature of Witness:

 

Name of Witness:
Address:

 

23

 

 

AS WITNESS this agreement has been signed by the duly authorised representatives of the parties.

 

SIGNED for and on behalf of
OXFORD UNIVERSITY INNOVATION LIMITED:
  SIGNED for and on behalf of
VACCITECH LIMITED
     
Name: DR. PAUL ASHLEY HEAD OF TECHNOLOGY TRANSFER LIFE SCIENCES   Name:
Position oxford university innovation LTD   Position:
       
Signature:   Signature:
     
Date:   Date:

 

24

 

Exhibit 10.5

 

EXECUTION VERSION

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED. 

 

Master Collaboration
Agreement

 

Dated                         

 

Vaccitech Limited (“Vaccitech")
CanSino Biologies Inc. ("CanSino")

 

King & Wood Mallesons
Octagon Point, 4th Floor
St. Martins Court
5 Cheapside
London EC2V 6AA
UK
T +44 20 3823 2405
www.kwm.com

 

 

 

 

Master Collaboration Agreement
Contents

 

Details   1
General terms   2
1 Definitions and interpretation 2
     
1.1 Definitions 2
1.2 General interpretation 4
2 Commencement and term 5
     
2.1 Master Collaboration Agreement 5
2.2 Project Agreements 5
3 Projects 5
     
3.1 Project Agreements 5
3.2 Conditions precedent 5
3.3 Conflict 6
4 Governance Framework 6
     
4.1 Party's commitments 6
4.2 No obligation 6
4.3 Relationship of parties 6
4.4 No restriction on other business 7
5 Performance of Projects 7
     
5.1 Performance of Projects 7
5.2 Data sharing 8
5.3 Risk to Product development 8
5.4 Research misconduct 8
5.5 Outcomes 8
5.6 Exclusivity 8
6 Materials 9
     
6.1 Materials 9
6.2 CanSino Material 9
7 Project Managers and Project Committees 10
     
7.1 Project Manager 10
7.2 Function of Project Manager 10
7.3 Project Committee 10
7.4 Function of Project Committee 10
7.5 Project Committee Voting and decisions 11
8 Project meetings 11
     
8.1 Project meetings 11
8.2 Project meeting requirements 11
8.3 Decisions of the Project Committee outside of Project meetings 12
9 Project reports 12
     
9.1 Progress reports 12
9.2 Final and milestone completion reports 12

 

i 

 

 

10 Joint Steering Committee 12
     
10.1 Establishment 12
10.2 Function 13
10.3 Composition 13
10.4 Voting and decisions 13
10.5 Chairperson 13
10.6 JSC meeting requirements 14
10.7 Decisions of the JSC outside of JSC meetings 14
11 Personnel 15
     
11.1 Personnel 15
11.2 Subcontractors 15
12 Records and inspection 15
     
12.1 Records 15
12.2 Record retention 16
12.3 Inspection 16
13 Access to premises 17
     
13.1 Access to a Partner's premises 17
13.2 Comply with a party's policies 17
13.3 Minimal disruption 17
14 Intellectual Property Rights 17
     
14.1 Product Intellectual Property Rights 17
14.2 Background IPR 17
14.3 Improvements 18
14.4 New IPR 18
14.5 Third party Intellectual Property Rights 18
14.6 Registration 18
14.7 Infringement 19
14.8 Further efforts 19
15 Exploitation 19
     
15.1 Background IPR 19
15.2 New IPR and Products 19
15.3 Pursue exploitation 20
15.4 Regulatory authorities 20
15.5 Patent markings 20
16 Financial obligations 20
     
16.1 Milestone payments 20
16.2 Royalties 20
16.3 Royalty reports 21
16.4 Invoices 21
16.5 Payment 21
16.6 Currency 21
16.7 Taxes 21
16.8 Interest 22
16.9 Additional information 22

 

ii 

 

 

17 Termination 22
     
17.1 Termination 22
17.2 Automatic termination 23
17.3 Consequences of termination 23
18 Confidentiality 24
     
18.1 Treatment of Confidential Information 24
18.2 Use of Confidential Information 24
18.3 Disclosure of Confidential Information 24
18.4 Disclosure by Recipient 25
18.5 Protecting Confidential Information 25
18.6 Return or destruction of Confidential Information 25
18.7 Exceptions 25
18.8 Publicity 25
18.9 OUI 26
19 Data protection 26
     
19.1 Definitions 26
19.2 Shared Personal Data 26
19.3 Compliance with Data Protection Legislation 26
19.4 Obligations 27
19.5 Mutual assistance 27
20 Publication 28
     
21 Representations and warranties 28
     
21.1 Representations and warranties 28
21.2 Exclusions 29
22 Liability 29
     
22.1 Indirect and consequential damages 29
22.2 Limitation of liability 29
22.3 Exclusions from limitation of liability 29
22.4 Insurance 30
22.5 Severability 30
23 Indemnity 30
     
23.1 Indemnity 30
23.2 Terms of indemnification 30
24 Anti-bribery 31
     
25 Disputes 31
     
25.1 Compliance with this clause 31
25.2 Dispute resolution process 32
25.3 Arbitration 32

 

iii 

 

 

26 Notices and other communications 32
     
26.1 Form 32
26.2 When effective 33
26.3 When taken to be received 33
26.4 Receipt outside business hours 33
27 Force majeure 33
     
27.1 Force majeure event 33
27.2 Termination 33
28 General 34
     
28.1 Entire agreement 34
28.2 Costs 34
28.3 Variation and waiver 34
28.4 Severability 34
28.5 Further steps 34
28.6 Assignment 34
28.7 Discretion in exercising rights 34
28.8 Partial exercise of rights 35
28.9 Approvals and consents 35
28.10 Remedies cumulative 35
28.11 Third party rights 35
28.12 Counterparts 35
28.13 Governing law and jurisdiction 35

 

Schedule 1 Project Agreement 36
     
Schedule 2 Deed of Covenant 9
     
Signing page   10

 

iv 

 

 

 

Master Collaboration Agreement

 

Details

 

Parties    
Vaccitech Name Vaccitech Limited
  Company number 09973585
  Formed in England
  Address Magdalen Centre, 1 Robert Robinson Avenue,
The Oxford Science Park, Oxford OX4 4GA
England
  Telephone [***]
  Email [***]
  Attention [***]
CanSino Name CanSino Biologics Inc.
  Company number 91120116681888972M
  Formed in China
  Address 185 South Avenue, TEDA West District, Tianjin
300457 China
  Telephone [***]
  Email [***]
  Attention [***]
Recitals A Vaccitech is an Oxford-based biopharmaceutical company which holds certain intellectual property rights relating to a platform technology, which it is developing for several therapeutic and prophylactic indications in humans and animals.
  B CanSino is a Tianjin-based biotechnology company dedicated to the R&D manufacturing and commercialisation of vaccine products for human use.
  C Vaccitech and CanSino may wish from time to time to undertake projects to collaborate on the research, development, manufacture and sale of certain products.
  D Vaccitech and CanSino intend to each contribute expertise, intellectual property, know-how and resources with respect to any such projects subject to, and on, the terms and conditions of this Agreement.
  E Vaccitech and CanSino intend that where CanSino is acting purely as a manufacturer for a product that is not being developed or commercialised as a project pursuant to this Agreement, this manufacturing will be arranged under a separate manufacturing agreement between the parties

 

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Master Collaboration Agreement

 

General terms

 

1Definitions and interpretation

 

1.1Definitions

 

In this agreement, unless the contrary intention appears, the following words and phrases have the following meanings

 

Affiliate means in relation to a party, a subsidiary or holding company of that party, and any subsidiary of a holding company of that party.

 

Background IPR means any Intellectual Property Rights (other than New IPR) owned by, licensed to or otherwise controlled by a party:

 

(a)before the start date of a Project Agreement, or

 

(b)created after the start date of a Project Agreement solely by such party without any use of the other party's Background IPR, New IPR or other Confidential Information.

 

which is used in connection with a Project.

 

Business Day means a day on which banks are open for general banking business in England and China (not being a Saturday Sunday, or public holiday in that country or in the city in which the relevant party is located as set out in the Details).

 

CanSino Territory means China (including Taiwan, Hong Kong and Macao), Malaysia, Thailand Myanmar, Indonesia, Lao, Vietnam, and the Philippines.

 

Confidential Information means the existence and nature of this agreement, and all information (regardless of how the information is stored or delivered):

 

(a)designated by a party, either orally or in writing, as confidential to that party or to a third party to whom that party owes an obligation of confidentiality;

 

(b)disclosed or made available by a party which relates to that party's business, financial affairs, systems, products developments, trade secrets, know-how, Personnel, customers, clients and suppliers;

 

(c)which given the circumstances of disclosure, would reasonably be regarded as confidential information of the party disclosing it or imparting a duty of confidence on the part of the recipient; and

 

(d)derived or produced partly or wholly from information set out in paragraphs (a) to (c) above,

 

whether that information is

 

(d)directly or indirectly disclosed or made available by or on behalf of a party to the other party, or

 

(e)obtained or discovered by that other party in the course of performing their obligations under this agreement, before, on <x after the date of this agreement,

 

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Good Industry Practice means in relation to any activity and under any circumstance, exercising the same skill, expertise and judgement and using facilities and resources of a similar or superior quality as would be expected from a person who is highly skilled and experienced in providing the services in question, seeking in good faith to comply with their regulatory and contractual obligations and seeking to avoid liability arising under any duty of care that might reasonably apply.

 

Improvements has the meaning set out in clause 14 3.

 

Intellectual Property Rights means any patents, trade marks, designs or applications for them, inventions, copyright, circuit layout rights, rights in and to trade or business names, trade secrets, know-how or confidential information, including any similar or analogous rights or forms of protection in any part of the world.

 

Joint Steering Committee and JSC have the meaning set out in clause 10.1 (Joint Steering Committee).

 

Materials means all compounds, fragments, proteins, viruses, DNA, RNA, biologic reagents, substances solutions and any other chemical or biological substance and any fragments, derivatives and progeny thereof, and any know- how associated with any such items

 

New IPR has the meaning set out in clause 14.4.

 

Net Sales means arm's length bona fide commercial Sales of Products and related services invoiced less the following deductions.

 

(a)trade, and quality discounts returns, and allowances, in amounts customary in the trade and actually given;

 

(b)import, export, excise, sales or use taxes, value added taxes and other taxes, tariffs or duties, to the extent these items are included in the gross invoice price and actually paid;

 

(c)freight, handling, transportation and insurance costs prepaid or allowed if separately identified in an invoice and actually paid; and

 

(d)amounts allowed or credited, or retroactive price reductions or rebates, and actually given or paid.

 

in the relevant country in which the Sale takes place. In relation to Sales which are not made in an arm's length, bona fide commercial manner, Net Sales shall be calculated by reference to the fair market price (if higher) of the relevant Product in the country in which the Sale takes place.

 

OUI means Oxford University Innovation Limited (formerly Isis Innovation Limited).

 

OUI Licence of Technology means the relevant Vaccitech Licence of Technology with OUI dated either 4 March 2016 or 8th September 2017.

 

Personnel means the employees, agents, officers, directors, auditors, advisors, authorised representatives or subcontractors of a party.

 

Product means a product developed pursuant to a Project Agreement using New IPR and potentially also incorporating Background IPR

 

Project means a project for the research, development manufacture and sale of Products as set out in a Project Agreement.

 

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Project Agreement means the written agreement between Vaccitech and CanSino in substantially the same format as set out in Schedule 1 (Project Agreement).

 

Project Committee has the meaning set out in clause 7.3 (Project Committee).

 

Regulatory Requirements means in relation to any undertaking and any circumstance, all laws, statutes and statutory instruments regulations, by-laws, guidelines codes of practice and standards determined by any governmental or regulatory authority, or judgements of a competent court of law or applicable rules of stock exchange which apply or may apply to that undertaking or to that circumstance from time to time.

 

Royalty Period [***]

 

Sale or Sell or Sold means, in relation to Products, to sell, distribute, license, supply commercially or otherwise dispose of or provide Products. Sales are deemed to have occurred at the earlier of the time when Products are delivered, title passes, or the recipient is invoiced or pays.

 

Term means 10 years from the date of this agreement.

 

Territory means in relation to a party either CanSino Territory or Vaccitech Territory, as relevant.

 

Vaccitech Territory means the rest of the world other than the CanSino Territory.

 

1.2General interpretation

 

Headings are for convenience only and do not affect interpretation. Unless the contrary intention appears in this agreement:

 

(a)labels used for definitions are for convenience only and do not affect interpretation;

 

(b)the singular includes the plural and vice versa;

 

(c)a reference to a document includes any agreement or other legally enforceable arrangement created by it (whether the document is in the form of an agreement, deed or otherwise);

 

(d)a reference to a document also includes any variation, replacement or novation of it;

 

(e)the meaning of general words is not limited by specific examples introduced by "including", "for example", "such as" or similar expressions;

 

(f)a reference to "person" includes an individual, a body corporate, a partnership, a joint venture, an unincorporated association and an authority or any other entity or organisation;

 

(g)a reference to a particular person includes the person's executors, administrators, successors, substitutes (including persons taking by novation) and assigns;

 

(h)a reference to "law" includes common law, principles of equity and legislation (including regulations);

 

(i)a reference to any legislation includes regulations under it and any consolidations, amendments, re-enactments or replacements of any of them;

 

(j)a reference to "regulations" includes instruments of a legislative character under legislation (such as regulations, rules by-laws, ordinances and proclamations);

 

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(k)a reference to any thing (including an amount) is a reference to the whole and each part of it;

 

(l)if a party must do something under this document on or by a given day and It is done after 5.00pm local time on that day, it is taken to be done on the next day; and

 

(m)if the day on which a party must do something under this document is not a Business Day, the party must do it on the next Business Day unless the timing of the obligation is specified by Regulatory Requirements in which case the party must do it on the preceding Business Day.

 

2Commencement and term

 

2.1Master Collaboration Agreement

 

(a)Subject to clause 2.1(b) and clause 17 (Termination), this agreement commences on the date this agreement is signed by both parties and continues until the expiry of the Term.

 

(b)At least [***] before the expiry of the Term, either party may give written notice to the other party expressing the desire to extend the Term and the parties may agree to extend the Term as a written variation to this agreement signed by both parties.

 

2.2Project Agreements

 

Subject to clause 17 (Termination), each Project Agreement commences on the start date set out in that Project Agreement and terminates upon the expiry of that Project Agreement.

 

3Projects

 

3.1Project Agreements

 

From time to time during the Term, the parties may discuss the potential for collaboration relating to one or more programs If the parties wish to undertake a Project, the parties shall use reasonable endeavours to complete and execute an agreement in the form of a Project Agreement. The parties shall use reasonable endeavours to agree and execute a Project Agreement for each proposed Project. Each Project Agreement incorporates the terms of this agreement by reference.

 

3.2Conditions precedent

 

The obligations of the parties to undertake and complete each Project are conditional upon the satisfaction of the following conditions as soon as possible after the execution by the parties of a Project Agreement for that Project:

 

(a)Vaccitech having obtained from OUI all consents required under the relevant OUI Licence of Technology for Vaccitech to undertake the Project with CanSino, and

 

(b)CanSino entering into a Deed of Covenant with OUI in relation to the Project in substantially the same format as set out in Schedule 2 (Deed of Covenant).

 

(together, Conditions). Each party shall use reasonable endeavours to obtain and maintain the satisfaction of the Conditions. If the Conditions have not been satisfied within [***] of the date of execution by the parties of a Project Agreement for that Project, the Project Agreement shall be terminated automatically and Vaccitech shall confirm the termination by notice in writing to CanSino.

 

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3.3Conflict

 

In the event of a conflict between the terms of

 

(a)this agreement;

 

(b)a Schedule to this agreement; and

 

(c)a Project Agreement;

 

the terms of the document lower in the list prevail unless specified in a writing by both parties.

 

4Governance Framework

 

4.1Party's commitments

 

Each party agrees and undertakes:

 

(a)to cooperate with the other party to undertake each Project;

 

(b)to the extent permitted by law, to promptly notify the other party;

 

(i)of any material legal, governance, policy, quality, regulatory or reputational issue arising in respect of this agreement or a Project Agreement (including any Product);

 

(ii)of any legal or regulatory issues (including any correspondence or interaction with a relevant regulator) that would have a material adverse impact on this agreement or a Project Agreement (including any Product);

 

(c)not to delay unreasonably any action, approval, direction, determination or decision required of it under this agreement or a Project Agreement; and

 

(d)to act reasonably and in good faith in the performance of its obligations and the exercise of its rights under this agreement or a Project Agreement.

 

4.2No obligation

 

Despite any other provision in this agreement or a Project Agreement to the contrary, a party is not obliged to do or omit to do anything if it would, or might in its absolute opinion, constitute a breach of any law.

 

4.3Relationship of parties

 

(a)Nothing contained or implied in this agreement or a Project Agreement constitutes a party the partner, agent or legal representative of another party for any purpose or creates any partnership, agency or trust.

 

(b)A party has no authority to bind the other party, or to act for, or to incur any obligation or assume any responsibility on behalf of, the other party.

 

(c)Each party is responsible for its own obligations arising under this Agreement and any Project Agreement and is not liable for any other party's obligations.

 

(d)Each party's liability under this agreement or a Project Agreement is several and not joint and several.

 

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4.4No restriction on other business

 

Except as provided for under this agreement (including clause 5.6 (Exclusivity)) or in any Project Agreement, nothing contained or implied in this agreement or in any Project Agreement restricts m any way the freedom of a party to conduct as it sees fit any other business or activities (including any arrangements with any third party), which may be undertaken without any accountability to the other party.

 

5Performance of Projects

 

5.1Performance of Projects

 

In respect of each Project, each party agrees that it shall:

 

(a)use its reasonable endeavours to complete all activities designated to it for a Project in accordance with the relevant Project Agreement;

 

(b)perform the Project in accordance with Good Industry Practice, in a good scientific manner, and in accordance with all Regulatory Requirements If the parties cannot agree on the appropriate regulatory requirements and standards, they shall seek advice from the appropriate regulator;

 

(c)perform the Project in accordance with all applicable ICH GxP standards, regulatory authorisations and approvals, and ethics approvals, and all generally accepted professional, clinical and research standards of care;

 

(d)subject to the compliance with applicable laws, perform the Project in a manner as to enable the transfer between and submission of data and information to the regulatory jurisdictions of the United Kingdom, the European Union, China and the United States of America;

 

(e)perform the Project in a manner which will not damage the name, business, reputation or goodwill of the other party;

 

(f)at its own cost (except where expressly provided otherwise in this agreement or a Project Agreement), apply all time, attention, resources, trained personnel and skill as may be reasonably necessary for the due and proper performance of the Project. Without limitation to the foregoing, each party shall provide all laboratories, computers and other equipment and resources reasonably required to perform the Project;

 

(g)hold and maintain all necessary licences, permits and consents necessary for it to perform the Project; and

 

(h)ensure that any animals involved in any part of the Project shall be provided with humane care and treatment in accordance with generally accepted veterinary practice and research ethics.

 

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5.2Data sharing

 

Unless specified in a Project Agreement or otherwise agreed by the parties, and subject to compliance with applicable laws, each party shall disclose promptly to the other party all data (including pharmacovigilance and the reporting of any serious adverse events) produced by or on its behalf pursuant to a Project Agreement in a prompt and timely manner. Both parties may use that data for submissions for regulatory approval within their respective Territories. For the avoidance of doubt, if:

 

(a)a party assigns or licenses its rights in relation to a Product to an unrelated third party in accordance with this agreement or the applicable Project Agreement and that third party is not acting on behalf of that party; or

 

(b)a party undergoes a change of control,

 

the scope of obligations regarding data sharing under this clause 5.2 shall be limited to the sharing of only that data as is reasonably necessary for development and commercialisation of a Product which shall be negotiated and agreed by the parties at the time acting in good faith and shall be subject to the approval of:

 

(c)m relation to the circumstances set out in paragraph (a), the unrelated third party, or

 

(d)in relation to the circumstances set out in paragraph (b), the third party that acquires control of that party.

 

5.3Risk to Product development

 

Either party shall have the right to terminate any Project activity that it is undertaking, directly or indirectly, in its Territory that it might reasonably deem to risk damage to the development of any Products or the safety of any person If a party terminates any Project activity, it shall immediately give written notice to the other party of the termination and grounds therefore and if after receipt of that notice, the other party continues that activity in that other party's Territory:

 

(a)the notifying Party is excluded from all liability for any claims related to the other Party's continued activity; and

 

(b)the other Party indemnifies the notifying Party in respect of claims related to the other Party's continued activity.

 

The limitations set out in clauses 22.1 and 22.2 (Liability) do not apply to this clause 5.3.

 

5.4Research misconduct

 

Each party will make and maintain arrangements for investigating and resolving allegations of research misconduct and inform the other party of any investigation undertaken or intended to be undertaken in connection with a Project Each part/ shall provide reasonable assistance with any investigation conducted by the other party into any alleged research misconduct.

 

5.5Outcomes

 

Although the parties shall carry out each Project in accordance with their respective obligations under this agreement and the relevant Project Agreement and using all reasonable endeavours to achieve the objectives of the relevant Project, the parties acknowledge and agree that neither party undertakes, represents or warrants that a Project will lead to any particular conclusion and nor does it guarantee a successful outcome to a Project.

 

5.6Exclusivity

 

During the term of a Project Agreement and for three months following the expiry or earlier termination of that Project Agreement, a party shall not enter into discussions, collaboration or similar arrangement with any third party regarding matters or products which are materially the same as those set out in that Project Agreement or related to the Project which is the subject of that Project Agreement (Arrangement) unless the party reasonably believes that the Arrangement is unlikely to prejudice or detrimentally affect the relevant Project or Project Agreement.

 

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6Materials

 

6.1Materials

 

(a)Subject to clause 6.1(b), each party shall provide to the other party all Materials specified m a Project Agreement and shall grant to the other party a non-exclusive, non-transferable, non-sub-licensable royalty-free licence to use the Materials solely for the purposes of the Project for the duration of the term of the Project Agreement for that Project.

 

(b)The parties acknowledge that Materials are made available for investigational use only for the purposes of a Project. Unless specified in a Project Agreement or otherwise agreed by the parties, a party shall not without the prior written consent of the other party use the other party's Materials:

 

(i)for the production or sale of any products or for commercial purposes;

 

(ii)for testing or evaluation on or in human beings;

 

(iii)to fulfil commercial licensing or contracted research obligations for another organization; or

 

(iv)in any way which is inconsistent with or which is expressly prohibited in a Project Agreement.

 

(c)Each party shall comply with any Regulator/ Requirements and any written instructions issued by the other party with respect to the storage, handling, transportation, use and disposal of the other party's Materials. The other party shall keep the Materials in a secure environment, protected against theft, damage, loss misuse and unauthorised access and in compliance with any security or storage requirements specified in the relevant Project Agreement.

 

(d)Each party shall promptly provide to the other party complete copies of any and all communications with any regulatory or other governmental authority relating to the Materials provided to it by the other party.

 

(e)Unless otherwise agreed by the parties, at the end of the term of the relevant Project Agreement, each party shall return to the other party, or at the other party's direction destroy, all remaining Materials of the other party and shall certify in writing that the same has been done.

 

(f)Each party acknowledges that the other party's Materials are supplied on an "as is" basis. To the maximum extent permitted at law, all representations, undertakings, warranties, terms and conditions that might but for this clause 6.1(f) have been implied or incorporated into this agreement with respect to the Materials, whether by statute, common law or otherwise, are expressly excluded (including any implied terms that the Materials are of satisfactory quality or fit for purpose).

 

6.2CanSino Material

 

(a)Unless specified in a Project Agreement or otherwise agreed by the parties, CanSino shall have the exclusive and sub-licensable right and responsibility (subject to terms and conditions mutually acceptable to the parties) to manufacture and supply all Master Virus Seed (MVS) and Good Manufacturing Practice (GMP) adenoviral material necessary for the development and Sale of any Products (CanSino Material) by either party in any part of either party's Territory to non-GMP and/or GMP standards (as required for the specified use of the CanSino Material at the time).

 

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(b)If reasonably requested by Vaccitech, CanSino shall enter into appropriate agreements to supply the CanSino Material to third parties (including sublicensees of Vaccitech) on the same terms of supply that CanSino shall supply the CanSino Materials to Vaccitech as set out in clause 6.2(c)

 

(c)CanSino shall supply any CanSino Material to be used by Vaccitech for the manufacture of Products to be Sold by Vaccitech (or its sublicensees) in the Vaccitech Territory at pricing of [***] over Cost of Goods Sold (COGS) where COGS is equal to reasonable COGS for equivalent material to the CanSino Material manufactured by CanSino or its subcontractors for Sale by CanSino (or its sublicensees) in the CanSino Territory.

 

7Project Managers and Project Committees

 

7.1Project Manager

 

Each party shall appoint one Project manager for each Project (Project Manager) to assume responsibility as set forth in clause 7.2 for that party's roles and obligations under the Project Agreement for that Project Each party:

 

(a)shall notify the other party in writing of the identity of the Project Manager it has appointed;

 

(b)may change its Project Manager from time to time, and shall notify the other party of that change in writing; and

 

(c)shall ensure that any Project Manager is adequately qualified for the role and informed about this agreement and the applicable Project Agreement.

 

7.2Function of Project Manager

 

In relation to each Project, each party's Project Manager for that Project shall

 

(a)co-ordinate all of that party's development work and other activities on that Project including facilitating and reporting the performance of that work;

 

(b)arrange and attend, at each party's own cost, Project meetings as described in clause 8 (Project meetings) and other meetings, at intervals and locations as agreed between the parties from time to time, to discuss developments and resolve any issues. The Project Managers shall use all reasonable endeavours to resolve issues arising under the relevant Project Agreement but shall refer all problems which are outside their ordinary authority to appropriate members of the parties' senior management to resolve, and

 

(c)prepare and agree regular reports in English.

 

7.3Project Committee

 

The parties shall establish a committee for the purposes of implementing each Project Agreement (Project Committee) which shall be composed of each party's Project Manager for that Project Each party shall ensure that its Project Manager has sufficient authority to make the decisions required of the Project Committee to implement the function set out in clause 7.4.

 

7.4Function of Project Committee

 

Without limiting clause 4.1 (Party's commitments), the implementation of each Project Agreement will be under the direction of the Project Committee for that Project The Project Committee shall consider and decide all things reasonably required in relation to its Project including:

 

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(a)having general oversight of for all activities performed under the Project Agreement including discussing the progress and status of the Project;

 

(b)considering, preparing and finalising detailed development and action plans;

 

(c)preparing and submitting comprehensive progress reports to the JSC under clause 9 (Project reports); and

 

(d)determining any other matter required to be determined by the Project Committee under this agreement.

 

For the avoidance of doubt, the Project Committee shall have no authority to amend this agreement or any Project Agreement.

 

7.5Project Committee Voting and decisions

 

(a)Each party has one vote for each decision made by the Project Committee.

 

(b)All decisions of the Project Committee require unanimous approval of both parties. If the matters cannot be approved by unanimous vote, it shall be dealt with in accordance with clause 25.2 (Dispute resolution process).

 

(c)The Project Committee shall jointly record the details of all decisions made.

 

(d)Each party agrees to give effect to decisions made by the Project Committee.

 

8Project meetings

 

8.1Project meetings

 

The parties shall arrange (and attend at their own cost) meetings to discuss and review the progress and status of any Project, and consider proposals and agree actions in relation to that Project with a view to ensuring the due and proper completion of all Projects in accordance with the Project Agreement for that Project.

 

8.2Project meeting requirements

 

(a)Attendees and frequency: The Project Committee together with any other representatives of each party shall meet as per the Project Agreement, or as otherwise agreed by the Project Committee.

 

(b)Location: Project meetings shall be held in a location as determined by the Project Committee, or by teleconference

 

(c)Technology: A Project meeting may be held at two or more venues using any technology that gives the Project Committee and other duly authorised representatives of each party a reasonable opportunity to participate.

 

(d)Notice: Unless otherwise agreed by the Project Committee, each Project Manager shall receive at least 5 Business Days' notice of each Project meeting. The notice shall include a draft agenda for comment, and shall be sent to other Project Manager by the coordinating Project Manager selected at the previous meeting

 

(e)Coordinating Project Manager: Each Project meeting shall be led by a coordinating Project Manager appointed as agreed by the Project Committee.

 

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(f)Papers: Unless otherwise agreed by the Project Committee papers for each Project meeting shall be circulated by the coordinating Project Manager selected at the previous meeting at least 5 Business Days prior to a Project meeting

 

(g)Minutes: The coordinating Project Manager shall arrange preparation of minutes and for a copy of the minutes of each Project meeting (Including decisions made) to be given to each Project Manager as soon as practicable, but no later than 5 Business Days after each Project meeting. The minutes are to be approved by both parties within 10 Business Days after receipt.

 

8.3Decisions of the Project Committee outside of Project meetings

 

Each party agrees that the Project Committee may make decisions outside Project meetings in accordance with the following requirements:

 

(a)Email: Project Committee decisions that are made outside of Project meetings may only be made via email correspondence;

 

(b)Correspondence: Each Project Manager shall be copied on emails that seek a decision of the Project Committee, and

 

(c)Voting: Clause 7.5 applies in respect of any decision out of session.

 

(d)Records: The coordinating Project Manager selected at the previous meeting shall prepare and file a copy of the decisions and circulate to each Project Manager.

 

9Project reports

 

9.1Progress reports

 

Each Project Committee shall:

 

(a)prepare regular comprehensive written reports (in English) as determined by the JSC in relation to the progress of each Project and as otherwise set out in the relevant Project Agreement; and

 

(b)submit its reports to the JSC on a pre-determined basis so they may be circulated to both parties as part of the papers poor to each JSC meeting.

 

9.2Final and milestone completion reports

 

Within a reasonable time of completion of each Project (or any major phase of a Project as agreed by the Project Committee), the Project Committee shall:

 

(a)prepare and agree a written report (in English) for that Project which sets out the work performed, and all Improvements and New IPR developed in sufficient detail to allow the parties to evaluate the commercial and scientific value of the results for that Project; and

 

(b)submit that written report to the JSC.

 

10Joint Steering Committee

 

10.1Establishment

 

The parties shall establish a committee for the purposes of implementing this agreement and the Project Agreements (Joint Steering Committee or JSC).

 

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10.2Function

 

Without limiting clause 4.1 (Party's commitments), the implementation of this agreement and all Project Agreements will be under the direction of the JSC. The JSC will consider and decide all things reasonably required in relation to this agreement and any Project Agreement including:

 

(a)having general oversight of for all activities performed under this agreement or any Project Agreement;

 

(b)establishing budgets and financial decision-making;

 

(c)approving any Product, and its Project Agreement (and any changes to a Project Agreement), provided that the execution of the Project Agreement and any changes to a Project Agreement will be subject to each party's internal approval;

 

(d)approving the strategy for communication about this agreement, a Product and any Project Agreement, including any public announcements and interactions with third parties, and

 

(e)determining any other matter required to be determined by the JSC under this agreement.

 

10.3Composition

 

Each party:

 

(a)shall appoint 3 JSC representatives each to represent It on the JSC;

 

(b)shall notify the other party in writing of the representative it has appointed;

 

(c)shall, as far as practicable, seek to ensure longevity of each person's tenure as that party's JSC representative; and

 

(d)may change its JSC representatives from time to time, and shall notify the other party of that change in writing.

 

10.4Voting and decisions

 

(a)Each party has one vote for each decision made by the JSC and each party shall direct its JSC representatives to exercise that vote together.

 

(b)All decisions of the JSC require unanimous approval of both parties. If the matters cannot be approved by unanimous vote, it shall be dealt with in accordance with clause 25.2 (Dispute resolution process).

 

(c)Each party agrees to give effect to decisions made by the JSC.

 

10.5Chairperson

 

(a)Each JSC meeting shall be led by a chairperson appointed m accordance with this clause 10.5 (Chairperson).

 

(b)Unless otherwise agreed by the JSC

 

(i)each Chairperson shall be appointed on an annual basis;

 

(ii)each time a new Chairperson is required:

 

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(A)one of the parties may nominate one of their JSC representatives to be the Chairperson in accordance with clause 10.5(b)(iii) on a rotating basis; and

 

(B)the parties shall agree on, and appoint, the Chairperson from those nominees; and

 

(iii)a party may only have a JSC representative as Chairperson for a maximum of one period each 12 months (such that each party will nominate a Chairperson on a revolving basis).

 

(c)For the avoidance of doubt, the Chairperson retains the right to vote (without a superior voting right) on all matters before the JSC in accordance with clause 10.4.

 

(d)The Chairperson is responsible for coordinating and providing leadership for the activities involved under the agreement and the Project Agreements, including circulating the agenda and the papers for any JSC meeting in accordance with the requirements of clause 10.6.

 

10.6JSC meeting requirements

 

(a)Frequency: The JSC shall meet every [***], or as otherwise agreed by the JSC.

 

(b)Location: JSC meetings shall be held in a location as determined by the JSC.

 

(c)Technology: A JSC meeting may be held at 2 or more venues using any technology that gives the JSC representatives a reasonable opportunity to participate.

 

(d)Notice: Unless otherwise agreed by the JSC, each JSC representative shall receive at least [***]notice of each meeting of the JSC, from the Chairperson The notice shall include an agenda, and shall be sent to all JSC representatives.

 

(e)Papers: Unless otherwise agreed by the JSC, papers for each JSC meeting shall be circulated at least [***] prior to a JSC meeting.

 

(f)Minutes: The Chairperson shall arrange for a copy of the minutes of each JSC meeting to be given to each JSC representative and each party as soon as practicable, but no later than 10 Business Days after each JSC meeting The minutes may be approved by each party's JSC representatives by giving notice to the other JSC representatives and are taken to be approved if no notice is given within 10 Business Days after receiving the minutes. If approved or taken to be approved by each party's JSC's representatives, the minutes shall be signed by the Chairperson of the relevant meeting and are then conclusive evidence of the proceedings and decisions of the JSC meeting to which they relate.

 

10.7Decisions of the JSC outside of JSC meetings

 

Each party agrees that the JSC may make decisions outside JSC meetings in accordance with the following requirements:

 

(a)Email: JSC decisions that are made outside of JSC meetings may only be made via email correspondence;

 

(b)Correspondence: Each JSC representative shall be copied on emails that seek a decision of the JSC; and

 

(c)Voting: Clause 10.4 applies in respect of any decision out of session.

 

(d)Records: The Chairperson shall prepare and file a copy of the decisions and circulate in accordance with clause 10.6(f).

 

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11Personnel

 

11.1Personnel

 

(a)Where the parties agree that the Project shall be performed by certain key Personnel of either party, those Personnel shall be named in the Project Agreement for that Project and shall perform the Project unless agreed otherwise by the Project Committee for that Project.

 

(b)Each party shall use only Personnel who have adequate training, and sufficient qualifications and experience to perform the Project Each party shall ensure its Personnel comply with all the obligations imposed on that party under this agreement and the applicable Project Agreement.

 

(c)A party's Personnel are not employees, representatives or agents of the other party. Each party will be entirely responsible for and pay all fees, wages, salaries withholding taxes, unemployment taxes, workers' compensation insurance premiums and other sums required by law to be paid m connection with its Personnel.

 

11.2Subcontractors

 

(a)Unless otherwise specified in this agreement, the applicable Project Agreement or separately agreed by the parties in writing, a party shall not use subcontractors to perform any of its obligations under a Project Agreement without the prior written consent of the other party (which consent shall not be unreasonable withheld or delayed). If a party has not responded to a notice from the other party requesting consent within [***] of receipt of the notice, consent is deemed to have been given by the party.

 

(b)Where a party uses subcontractors to perform any of its obligations under a Project Agreement, that party:

 

(i)shall ensure those subcontractors have agreed to:

 

(A)confidentiality obligations at least as restrictive as those set out in this agreement; and

 

(B)obligations regarding the rights to use any Intellectual Property Rights, and assignment of any Improvements and New I PR developed by those subcontractors (other than Background IPR of those subcontractors) consistent with and at least as restrictive as those set out in this agreement or the relevant Project Agreement; and

 

(ii)remains primarily liable to the other party for all acts of the subcontractors as if they were employees of the first party acting within the scope of their authority.

 

12Records and inspection

 

12.1Records

 

Each party shall keep clear, full, accurate and up to date records together with any relevant supporting material of all:

 

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(a)details of Sales of Products, the deductions used to calculate the Net Sales value and any other information necessary to enable the other party to verify the calculation of royalties payable;

 

(b)its activities performed in connection with this agreement and all Project Agreements (Activities);

 

(c)materials including laboratory notebooks, worksheets, records reports and data obtained or generated in the course of undertaking its Activities;

 

(d)time, costs and expenses incurred in undertaking its Activities, and

 

(e)all Personnel, materials, products, parts and equipment used m connection with undertaking its Activities,

 

(together, Records).

 

12.2Record retention

 

Each party shall retain all Records during the term and for the longer of

 

(a)the period of time required by any Regulatory Requirements; or

 

(b)[***] after the date of termination or expiry of the relevant Project Agreement; or

 

(c)[***] after the period during which sales continue and Royalties are payable to either party.

 

12.3Inspection

 

(a)Until the expiry of the retention period set out in clause 12.2, upon reasonable prior written notice from a party, the other party shall, during normal business hours and with minimum interference with the other party's business operation:

 

(i)make available its Records, and relevant Personnel;

 

(ii)allow reasonable access to its premises and procure access to the premises, records and relevant personnel of its subcontractors where relevant; and

 

(iii)provide all reasonable information and assistance,

 

to the notifying party and its Personnel (including an independent auditor selected by the first party), and any other relevant competent government or regulatory authority for the purposes of monitoring and carrying out an audit of that other party's compliance with this agreement and any Project Agreement including all activities and the calculation of any royalties and charges as may be reasonably appropriate having regard to the nature and progress of the relevant Project at any time or as may be required to comply with Regulatory Requirements (Audit) The first party may take copies of or extracts from that other party's Records for the purposes of carrying out the Audit. Before performing an Audit, any auditor shall agree to maintain the confidentiality at least as restrictive as those set out in this agreement of a party's Records and not disclose to third parties the contents of any Records.

 

(b)In the event that an Audit reveals a discrepancy in the royalties or other amounts paid from those payable under this agreement or a Project Agreement, a party shall refund any overpayment and a party shall pay any underpayment immediately. Where an Audit undertaken by one party reveals an underpayment the other party which exceeds [***] of the total royalties payable for the Royalty Period under audit, the other party shall pay for the cost of the Audit otherwise the first party shall pay for the cost of the Audit

 

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13Access to premises

 

13.1Access to a Partner's premises

 

(a)Subject to clauses 13.2 and 13.3 and clause 18 (Confidentiality), a party may allow certain pre-approved and nominated Personnel of the other party access (during business hours, on reasonable notice) to designated areas within the first party's premises to the extent reasonably required to enable the other party to participate in a Project in accordance with the terms of this agreement and the applicable Project Agreement for that Project.

 

(b)A party may at any time (acting reasonably) deny access to another party or remove its Personnel from the list of approved Personnel of that party (whether temporarily or permanently) where that party breaches any of the provisions of clauses 13.2 or 13.3 or clause 18 (Confidentiality).

 

13.2Comply with a party's policies

 

A party shall comply, and shall ensure that its Personnel comply, with all reasonable security, privacy, confidentiality, health and safety, and office conduct policies and procedures notified to that party and reasonable directions of the other party whilst on that other party's premises.

 

13.3Minimal disruption

 

A party shall ensure that its Personnel will cause no more than minimal disruption to the other party while accessing that other party's premises in accordance with this agreement and the applicable Project Agreement.

 

14Intellectual Property Rights

 

14.1Product Intellectual Property Rights

 

Prior to commencing the implementation of a Project Agreement for a Product each party shall undertake searches to determine and confirm the status (significant or otherwise) of Intellectual Property Rights for that Product in strategic countries in that party's Territory. The JSC and the Project Committee for the relevant Project shall take into account the results of each party's searches and agree an appropriate Intellectual Property Rights strategy for the implementation of that Project.

 

14.2Background IPR

 

(a)Each party shall give full disclosure to the other party of all Background IPR owned or licensed by it which is relevant to a Project.

 

(b)All Background IPR is and shall remain the exclusive property of the party owning it (or, where applicable, the third party from whom its right to use the Background IPR has derived) and nothing in this agreement or any Project Agreement shall operate to transfer any Background IPR of one party to the other party.

 

(c)Each party grants to the other party a royalty-free, non-exclusive licence to use the first party's Background IPR to the extent necessary to perform the Project in the other party's Territory together with a right to sub-license to any subcontractor performing services for and on behalf of the other party in accordance with clause 11.2 (Subcontractors).

 

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14.3Improvements

 

Except as agreed otherwise in a Project Agreement, any modifications, enhancements or improvements of a party's Background IPR and all associated Intellectual Property Rights (Improvements) will be owned by that party regardless of who created the Improvements but they will be treated as Background IPR for the purposes of the licence granted to the other party under clause 14.2(c). Each party assigns to the other party any rights, title and interest the first party may have in the Improvements so as to perfect the other party's ownership in the Improvements.

 

14.4New IPR

 

Any new Intellectual Property Right created, generated, developed, derived conceived or first reduced to practice in the course of activities performed by a party in relation to a Project or otherwise under this agreement or a Project Agreement, which is not derived from either party's Background IPR or Improvements and all associated Intellectual Property Rights (New IPR), will be owned by the parties in shares to reflect the respective inventive contribution of each party to that New IPR as determined by the principles of United Kingdom patent law unless specified otherwise m the relevant Project Agreement. The parties may assign or license their rights to any New IPR to each other in relation to a Project as specified in the relevant Project Agreement or as otherwise agreed between the parties at any time.

 

14.5Third party Intellectual Property Rights

 

If a party licenses any Intellectual Property Rights from a third party in relation to a Project, that party shall make reasonable efforts to ensure that the other party receives a licence from that third party for those Intellectual Property Rights upon equal terms for use in the other party's Territory.

 

14.6Registration

 

(a)Except where otherwise agreed by the parties or expressly provided otherwise in a Project Agreement, if any New IPR for a Product is.

 

(i)wholly owned by one party, that party shall use all reasonable endeavours to carry out, at its own expense the drafting, filing and prosecution of all patent applications and the maintenance and extension, of all patent registrations comprised in the New IP in those parts of the world to the extent required to provide reasonable patent protection for that Product for the term of the relevant Project Agreement; and

 

(ii)jointly owned by the parties, Vaccitech shall use all reasonable endeavours to carry out the drafting, filing and prosecution of all patent applications and the maintenance and extension, of all patent registrations comprised in the New IP in those parts of the world to the extent required to provide reasonable patent protection for that Product for the term of this agreement in consultation with CanSino (Joint Project Patents) The parties shall share all costs in relation to these patent applications and registrations as agreed at the time or set out in the relevant Project Agreement.

 

(b)Before abandoning any Joint Project Patents in any country or withholding payment of any fee necessary for procuring or keeping in force a Project Patent in any country upon the expiry of earlier termination of a Project Agreement relevant to that Joint Project Patent, Vaccitech shall give CanSino at least [***] prior written notice of Vaccitech s intended course of action. Before the expiry of the notice period, CanSino may re-quest the assignment of Vaccitech's rights to the Joint Project Patent from Vaccitech to CanSino on terms to be agreed by the parties at the time.

 

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14.7Infringement

 

A party shall notify the other party m writing immediately, giving full particulars, if it becomes aware of any of the following:

 

(a)any actual suspected or threatened infringement or any actual, suspected or threatened unauthorised disclosure, misappropriation or misuse of any New IPR by a third party;

 

(b)any actual or threatened claim that any patent application or registered patent m relation to any New IPR or related Background IPR is invalid;

 

(c)any actual or threatened opposition to any patent application or registered patent in relation to any New IPR or related Background IPR;

 

(d)any claim made or threatened that any New IPR or related Background IPR infringes the rights of any third party;

 

(e)any person applies for, or is granted, a patent by reason of which that person may be or has been, granted rights that conflict with any New IPR or related Background IPR;

 

(f)any other form of attack, charge or claim to which the New IPR or related Background IPR may be subject; and

 

(g)if the notifying party proposes to issue proceedings for the revocation of or opposition to any patent or patent application of any third party for the purpose of more effectively implementing the notifying party's rights of exploitation of any New IPR or related Background IPR, and

 

the parties shall discuss appropriate steps to take in the circumstances to properly protect the New IPR or related Background IPR including bringing legal proceedings. Neither these discussions nor any delay in an agreement between the parties regarding appropriate steps to take shall prevent either party taking whatever steps it believes appropriate to properly protect the New IPR and related Background IPR in its Territory.

 

14.8Further efforts

 

Each party agrees to execute (and, to the extent necessary, procure that any of its Personnel involved in a Project execute) all documents and assignments and do (and, to the extent necessary, procure that any of its Personnel involved in a Project do) all things as may be reasonably necessary to perfect the other party's Wie to Intellectual Property Rights or to register the other party as owner of registrable rights in accordance with this agreement and the relevant Project Agreement.

 

15Exploitation

 

15.1Background IPR

 

Each party grants to the other party a non-exclusive licence to use the first party's Background IPR to the extent necessary to commercialise and exploit New IPR and Products in the other party's Territory together with a right to sub-license (each sublicence to have no further right to sublicense) subject to the payment of milestone payments and royalties in accordance with the Project Agreement for those Products.

 

15.2New IPR and Products

 

Each party grants to the other party an exclusive licence to use the first party's New IPR to the extent necessary to commercialise and exploit Products developed using that New IPR in the other party's Territory together with a right to sub-license (each sublicence to have no further right to sublicense) subject to the payment of milestone payments and royalties in accordance with the Project Agreement for those Products.

 

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15.3Pursue exploitation

 

Each party agrees to use commercially reasonable endeavours to exploit the New IPR licensed to it by the other party under a Project Agreement and maximise Net Sales of Products developed using that New IPR m the first party's Territory during the term of the Project Agreement including:

 

(a)obtaining all necessary regulatory approvals in countries throughout its Territory for the exploitation of the Products;

 

(b)using its best endeavours to sell and market the Products in all countries in the Territory;

 

(c)seeking to maximise the royalties and milestone payments paid to the other party;

 

(d)not engaging in any exploitation of the New IPR and Products in competition with the purpose contemplated by this agreement and the Project Agreement;

 

(e)not engaging In any exploitation of the New IPR and Products other than in accordance with this agreement and the Project Agreement; and

 

(f)comply with all Regulatory Requirements relating to the importation distribution, testing sale, supply or manufacture of the Products,

 

15.4Regulatory authorities

 

(a)The parties shall review and agree any regulatory documents and correspondence related to a Product prior to submission to a regulatory authority in any country. A party shall provide copies and where appropriate summary translations into English of all minutes of meetings with regulatory authorities and correspondence in relation to a Product to the other party

 

(b)Each party shall provide to the other party any information and assistance reasonably requested by the other party for any regulatory filing or compliance activities relating to a Product in its Territory.

 

15.5Patent markings

 

Each party shall include, and shall ensure that its sublicensees include, relevant patent or patent application numbers on all packaging and promotional material for any Products in compliance with the Regulatory Requirements of each country in that party s Territory where the Products are supplied, sold or distributed

 

16Financial obligations

 

16.1Milestone payments

 

Each party shall pay to the other party any milestone payments in accordance with the Project Agreement for that Product.

 

16.2Royalties

 

Each party shall pay to the other party ongoing royalties on Net Sales in its Territory in relation to each Product Sold at the rate set out in the Project Agreement for that Product.

 

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16.3Royalty reports

 

At the same time as payment of the royalties falls due under clause 16 2 each party shall supply a written report for the relevant Royalty Period to the other party showing:

 

(a)identification by quantity and description of Products Sold or transferred by the first party or any sub-licensees of the first party;

 

(b)the total royalties payable for that Royalty Period;

 

(c)the deductions used to calculate the Net Sales value and any other information necessary to enable the other party to verify the calculation of royalties payable for that Royalty Period; and

 

(d)details of payments and royalties received from sublicensees including the deductions used to calculate the Net Sales value and any other information necessary to enable the other party to verify the calculation of royalties payable by a party's sublicensee to that party for that Royalty Period.

 

16.4Invoices

 

If a Project Agreement provides that a party shall pay the other party any amount, the other party shall deliver to the first party an invoice for payment of amounts payable in accordance with the Project Agreement Subject to clause 16.7, all amounts payable are stated exclusive of value added tax, or any other taxes or duties (if any) payable.

 

16.5Payment

 

(a)Within [***] of the date of the end of each Royalty Period, each party shall pay the other party the royalties payable for that Royalty Period.

 

(b)Within [***] of the due date for any milestone payment as set out in the relevant Project Agreement, each party shall pay the other party that milestone payments.

 

(c)Each party shall pay all other amounts properly due and undisputed in respect of any validly presented invoice within [***] of the date of receipt by that party of the invoice for those amounts.

 

(d)Within [***] of the date of receipt by a party of an invoice from the other party, the first party shall notify the other party of any genuinely disputed amount and the reasons for the dispute. If no dispute is raised by the first party to the other party in relation to an invoice, the invoice is deemed to be undisputed.

 

(e)A party shall pay all disputed amounts in respect of any invoice within [***] of the dispute being resolved by the parties.

 

(f)Subject to clause 16 7, each party shall pay all amounts properly due and undisputed under this agreement or a Project Agreement in full without any set-off, counterclaim or deduction.

 

16.6Currency

 

All payments shall be made in pounds sterling. Where CanSino calculates the royalties in RMB, CanSino shall convert those royalties into pounds sterling [***].

 

16.7Taxes

 

If the royalties, milestone payments and any other amounts payable by a party under this agreement or a Project Agreement are subject to withholding tax, charge, deduction or other like withholding, that party may withhold monies and pay any tax upon its payments to the other party where that income tax is due and payable by the other party provided that the first party uses all reasonable efforts to obtain any available exemption from the payment of that income tax and gives the other party a tax certificate or similar official record for any payment of income tax.

 

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16.8Interest

 

Each party shall pay interest on any overdue payments from the date the payment is due until the day of payment (both dates inclusive) at [***] per annum calculated on a daily basis from the due date until payment of the overdue amount payable is received by the other party in cleared funds. The parties agree that this constitutes a substantial remedy in terms of the Late Payments of Commercial Debts (Interest) Act 1998 (UK). Each party shall pay the interest together with the overdue amount.

 

16.9Additional information

 

Where reasonably requested by a party, the other party shall supply additional information regarding any invoice or royalty report as necessary for the first party to confirm that the correct amounts have been paid by the other party under this agreement or any Project Agreement.

 

17Termination

 

17.1Termination

 

This agreement or a Project Agreement may be terminated'

 

(a)by mutual agreement of the parties;

 

(b)by either party immediately by written notice to the other party if the other party commits a material breach of this agreement or a Project Agreement and either:

 

(i)the breach is not capable of being cured; or

 

(ii)the breach is capable of being cured and the other party fails to cure the breach within [***] of being notified m writing of the breach by the party giving the notice;

 

(c)by either party immediately by written notice to the other party if the other party commits persistent breaches of this agreement;

 

(d)by either party immediately by written notice to the other party if the other party uses or permits a third party to use the first party's Background IPR or New IPR outside the scope of licences granted to it under this agreement or a Project Agreement without the first party's prior written consent, or otherwise infringes the first party's Background IPR or New IPR;

 

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(e)by either party immediately by written notice to the other party if the other party:

 

(i)fails to pay any amount due under this agreement on the due date for payment and remains in default not less than a further [***] after being notified in writing that it is in default and to make such payment;

 

(ii)suspends, or threatens to suspend, payment of its debts (unless those debts are the subject of a genuine dispute) or is unable to pay its debts as they fall due or admits inability to pay its debts;

 

(iii)takes any step or action for or in connection with its entering administration, provisional liquidation or any composition or arrangement with its creditors (other than in relation to a solvent amalgamation or restructuring), being wound up (whether voluntarily or by order of the court, unless for the purpose of a solvent amalgamation or restructuring), having a receiver appointed to any of its assets or ceasing to carry on business or, if the step or action is taken in another jurisdiction, in connection with any analogous procedure in the relevant jurisdiction; or

 

(iv)suspends or ceases, or threatens to suspend or cease, carrying on all or a substantial part of its business; and

 

(f)by either party in accordance with clause 27.2 (Force majeure).

 

17.2Automatic termination

 

(a)A Project Agreement shall terminate automatically if OUI does not consent or withdraws any consents granted under clause 3.2(a) relevant to that Project Agreement and Vaccitech, acting reasonably, does not contest such withdrawal of consent.

 

(b)If:

 

(i)any Background IPR necessary for a Project is licensed from OUI to Vaccitech under the OUI Licence of Technology and the OUI Licence of Technology expires or is terminated earlier; and

 

(ii)using all reasonable endeavours, the parties cannot agree upon a modification to the Project (or relevant Product) in order to continue without using that Background IPR,

 

that Project Agreement shall terminate automatically.

 

17.3Consequences of termination

 

(a)The expiry or termination of one Project Agreement does not terminate another Project Agreement or this agreement. The early termination of this agreement terminates all Project Agreements. Despite the expiry of the Term of this agreement, the agreement is deemed to continue and apply to any outstanding Project Agreement until the expiry or earlier termination of that Project Agreement, unless otherwise agreed by the parties.

 

(b)Subject to clause 17 3(c) and unless otherwise agreed by the parties, on expiry or earlier termination of a Project Agreement, whether for breach or otherwise, each party shall:

 

(i)bring all relevant sub-licences from that party to third parties to an end on the same date;

 

(ii)pay all outstanding royalties, milestone payments and other sums due or that have become due to the other party under the Project Agreement;

 

(iii)provide the other party with details of the stocks of Products relevant to that Project Agreement held at the point of termination;

 

(iv)cease to use or exploit any jointly-owned New IPR, provided that this restriction does not apply to know-how or Confidential Information which has entered the public domain through no fault of that party, and that that party may continue to use the jointly-owned New IPR in order to meet any specific existing binding commitments already made by that party at the date of termination and requiring delivery of Products within the next [***]; and

 

(v)subject to clause 17.3(b)(iv), destroy all other Products relevant to that Project Agreement and confirm m writing the destruction thereof if those Products use any jointly-owned New IPR, or any Intellectual Property Rights owned or licensed from the other party.

 

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(c)Except in the event of termination of a Project Agreement by CanSino for breach by Vaccitech, upon expiry or earlier termination of a Project Agreement, CanSino grants Vaccitech a non-exclusive, royalty-free, worldwide, perpetual, irrevocable licence to use any CanSino Background IPR, CanSino New IPR or jointly-owned New IPR used to develop, incorporated in, or referenced in any Product which is the subject of that Project Agreement to the extent necessary for Vaccitech to undertake research, development, manufacture, Sell or otherwise commercialise any Product which is the subject of that Project Agreement together with a right to sub-license to third parties for those purposes.

 

(d)Expiry or termination of this agreement or a Project Agreement, whether for breach or otherwise shall not relieve a party of its obligation to accrue and pay royalties to the other party under the provisions of clause 16 (Financial obligations) for the duration of any notice period and in respect of any dealings in Products permitted by clause 17.3(b).

 

(e)Despite clauses 17.1 and 17.2, any rights of the parties accrued prior to expiry or termination of this agreement, or prior to expiry or termination of a Project Agreement, and clauses 5.3 (Risk to Product development), 6.1(e) (Materials), 12 2 and 12.3 (Records and inspection), 14 (Intellectual Property Rights), 16 (Financial obligations), 17.3 (Consequences of termination), 18 (Confidentiality), 18.9 (Data Protection), 20 (Publication), 21 (Representations and warranties), 22 (Liability), 25 (Disputes), 26 (Notices and other communications) and 28 (General) survive expiry or termination of this agreement for any reason.

 

18Confidentiality

 

18.1Treatment of Confidential Information

 

Each party acknowledges that the Confidential Information of the other party is valuable to the other party. Each party undertakes to keep the Confidential Information of the other party secret and to protect and preserve the confidential nature and secrecy of that Confidential Information.

 

18.2Use of Confidential Information

 

A party receiving Confidential Information (Recipient) may only use the Confidential Information of the party disclosing Confidential Information (Discloser) for the purposes of performing the Recipient's obligations or exercising the Recipient's rights under this agreement.

 

18.3Disclosure of Confidential Information

 

A Recipient may not disclose Confidential Information of the Discloser to any person except:

 

(a)Personnel of the Recipient who require it for the purposes of this agreement;

 

(b)with the prior written consent of the Discloser;

 

(c)if the Recipient is required to do so by law or a stock exchange; or

 

(d)if the Recipient is required to do so in connection with legal proceedings relating to this agreement.

 

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18.4Disclosure by Recipient

 

A Recipient disclosing Confidential Information under clauses 13.3(a), 18.3(b) or 18.3(d) shall use all reasonable endeavours to ensure that persons receiving the Confidential Information from it do not disclose the information except in accordance with this agreement and the Recipient will be responsible for any act or omission of that person in relation to the Confidential Information as if it was the Recipient's own act or omission.

 

18.5Protecting Confidential Information

 

(a)The Recipient shall take reasonable steps to protect the Confidential Information of the Discloser and keep it secure from any unauthorised use or disclosure.

 

(b)The Recipient shall promptly notify the Discloser on becoming aware of any use or disclosure of its Confidential Information in breach of this agreement, and shall cooperate with the Discloser to Investigate that breach and mitigate any adverse impact on the Discloser.

 

18.6Return or destruction of Confidential Information

 

Subject to clause 18.7, on the Discloser's request, the Recipient shall immediately destroy or deliver to the Discloser all documents or other materials containing or referring to the Discloser's Confidential Information which are:

 

(a)in the Recipient's possession, power or control; or

 

(b)in the possession, power or control of persons who have received Confidential Information from the Recipient under clauses 18 3(a) or 18.3(b).

 

18.7Exceptions

 

The obligation in clause 18 6 does not apply to Confidential Information of the Discloser that the Recipient requires in order to perform its obligations under this agreement or is otherwise entitled to retain to comply with Regulatory Requirements, including the rules of the relevant stock exchange.

 

18.8Publicity

 

(a)Neither party may make any statement, press release or other announcement relating to this agreement a Project Agreement, a Product, or the other party (Publicity) without the other party's prior written consent as to form, timing and content.

 

(b)If any Regulatory Requirements including the rules of the relevant stock exchange require a party to release any Publicity:

 

(i)that party shall submit to the other party a copy of the proposed Publicity as early as possible prior to its required release; and

 

(ii)the other party shall use all reasonable efforts to notify the first party of its consent to the proposed Publicity or any objections by the date required by the first party.

 

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18.9OUI

 

(a)Neither party may use the name of OUI, the University, or any inventor of the Intellectual Property Rights licensed to Vaccitech under the OUI Licence of Technology, in any Publicity without the prior written consent of OUI. Each party acknowledges that OUI may enforce its rights under this clause 18.9(a) despite not being a party to this agreement.

 

(b)If Vaccitech's Confidential Information contains any confidential information of OUI, the parties acknowledge that OUI may enforce this clause 18 despite not being a party to this agreement.

 

(c)For the purposes of this clause 18.9, the "University" means the Chancellor, Masters and Scholars of the University of Oxford whose administrative offices are at the University Offices, Wellington Square, Oxford 0X1 2JD, England.

 

19Data protection

 

19.1Definitions

 

For the purposes of this clause 19, unless the contrary intention appears, the following words and phrases have the following meanings:

 

Data Protection Legislation means the General Data Protection Regulation ((EU) 2016/679) and any other directly applicable European Union regulation relating to privacy, any data protection legislation from time to time in force in the United Kingdom and China, and any other data protection or privacy legislation applicable in the relevant jurisdiction.

 

Data controller, data subject, personal data, processing, and appropriate technical and organisational measures have the meanings as set out in the Data Protection Legislation in force at the time.

 

Permitted Recipients means the parties, the Personnel of each party, sublicensees of a party, and any third parties engaged to perform obligations in connection with this agreement including regulatory authorities.

 

Shared Personal Data means any personal data to be shared between the parties under this agreement or a Project Agreement.

 

19.2Shared Personal Data

 

This clause 19 sets out the framework for the sharing of personal data between the parties as data controllers. Each party acknowledges that one party (Data Discloser) will regularly disclose to the other party (Data Recipient) Shared Personal Data collected by the Data Discloser for the purposes of this agreement and any Project Agreement.

 

19.3Compliance with Data Protection Legislation

 

(a)Each party shall comply with all applicable requirements of the Data Protection Legislation in relation to the Shared Personal Data and any activities undertaken in relation to this agreement and any Project Agreement.

 

(b)Any material breach of the Data Protection Legislation by one party in relation to the Shared Personal Data, or any activities undertaken by that party in relation to this agreement or any Project Agreement, shall be considered to be a material breach of this agreement and give grounds to the other party to terminate this agreement under clause 17.1(b) (Termination).

 

© King & Wood MallesonsMaster Collaboration Agreement
4 September 2018
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19.4Obligations

 

In relation to the Shared Personal Data and any activities undertaken in relation to this agreement and any Project Agreement, each party shall:

 

(a)ensure that it has all necessary notices and consents in place to enable lawful transfer of the Shared Personal Data to the Permitted Recipients for the purposes of this agreement and any Project Agreement;

 

(b)give full information to any data subject whose personal data may be processed under this agreement of the nature such processing. This includes giving notice that, on the termination of the relevant Project Agreement, personal data relating to them may be retained by or, as the case may be, transferred to one or more of the Permitted Recipients, their successors and assignees;

 

(c)process the Shared Personal Data only for the purposes of this agreement and any Project Agreement;

 

(d)not disclose or allow access to the Shared Personal Data to anyone other than the Permitted Recipients;

 

(e)ensure that all Permitted Recipients are subject to written contractual obligations concerning the Shared Personal Data (including obligations of confidentiality) which are no less onerous than those imposed by this agreement;

 

(f)ensure that it has m place appropriate technical and organisational measures to protect against unauthorised or unlawful processing of personal data and against accidental loss or destruction of, or damage to, personal data; and

 

(g)unless absolutely necessary or required to comply with Regulatory Requirements, only disclose or share data relating to individuals in a de- identified or anonymised format.

 

19.5Mutual assistance

 

Each party shall assist the other in complying with all requirements of the Data Protection Legislation applicable to the other party's obligations under this agreement or any Project Agreement. In particular, each party shall:

 

(a)consult with the other party about any notices given to data subjects in relation to the Shared Personal Data;

 

(b)promptly notify the other party about the receipt of any data subject access request;

 

(c)provide the other party with reasonable assistance in complying with any data subject access request;

 

(d)not disclose or release any Shared Personal Data in response to a data subject access request without first consulting the other party wherever possible,

 

(e)provide reasonable assistance the other party, at the cost of the other party, in responding to any request from a data subject and in ensuring compliance with its obligations under the Data Protection Legislation with respect to security, breach notifications, impact assessments and consultations with supervisory authorities or regulators;

 

(f)notify the other party without undue delay on becoming aware of any breach by it of the Data Protection Legislation;

 

(g)at the written direction of the Data Discloser, delete or return Shared Personal Data and copies thereof to the Data Discloser on expiry or earlier termination of the relevant Project Agreement unless required to retain the personal data by any Regulatory Requirements;

 

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