Document:

exh_1042.htm

Exhibit 10.42

 

Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

 

 

 

MANUFACTURING AND CLINICAL TRIAL AGREEMENT

 

BETWEEN

THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD

 

AND

 

TEKMIRA PHARMACEUTICALS CORPORATION

ON BEHALF OF ITSELF AND ITS WHOLLY OWNED AFFILIATE,

PROTIVA BIOTHERAPEUTICS INC.

 

 

 

 

DATED DECEMBER 18TH, 2014

 

  

  

  

Table of Contents

 

 

	
Article 1 Interpretation

	
1

	
1.1   Definitions

	
1

	 	 
	
Article 2 Engagement

	
7

	
2.1   Appointment of TEKMIRA

	
7

	
2.2   Change Orders

	
7

	
2.3   OXFORD performance of the Clinical Trial

	
7

	
2.4   TEKMIRA performance of Clinical Trial activities

	
8

	 	 
	
Article 3 Manufacturing Services

	
8

	
3.1   Use of Materials and Investigational Medicinal Product

	
8

	
3.2   Storage

	
8

	
3.3   Transport and Risk of Loss

	
8

	
3.4   Reporting and Records

	
9

	 	 
	
Article 4 Compensation

	
9

	
4.1   Costs, Invoicing, Payment and Audit

	
9

	
4.2   Future Development and Use of the Investigational Medicinal Product

	
10

	 	 
	
Article 5 Regulatory Compliance, Support and Responsibilities

	
10

	
5.1   Anti-Bribery

	
10

	
5.2   Clinical Samples

	
10

	
5.3   Regulatory Support

	
11

	
5.4   Responsibilities

	
11

	
5.5   Records, Audits and Inspections

	
11

	
5.6   Variation

	
12

	 	 
	
Article 6 Clinical Trial

	
12

	
6.1   Protocol Development

	
12

	
6.2   Conduct of Clinical Trial

	
13

	
6.3   Personnel

	
13

	
6.4   Ethical and Regulatory Approvals

	
13

	
6.5   Trial Sites

	
14

	
6.6   Data Protection

	
14

	
6.7   Pharmacovigilance

	
14

	
6.8   Insurance

	
15

	 	 
	
Article 7 Intellectual Property

	
15

	
7.1   Background IP

	
15

	
7.2   Arising IP

	
15

	
7.3   Perfection of Ownership Rights

	
16

	 	 
	
Article 8 Confidentiality

	
16

	
8.1   Confidentiality Obligations

	
16

	
8.2   Publication

	
17

	
8.3   No License

	
18

	
8.4   Return of Confidential Information

	
19

	 	 

 

  

i

  

	
Article 9 Representations, Warranties  and  Covenants

	
19

	
9.1   Mutual Representations and Warranties

	
19

	
9.2   Individual Representations and Warranties

	
19

	
9.3   Disclaimers

	
19

	
9.4   No Implied Warranties

	
20

	 	 
	
Article 10 LIABILITY

	
20

	
10.1   OXFORD

	
20

	
10.2   TEKMIRA

	
20

	
10.3   Conditions

	
20

	
10.4   LIMITATION OF LIABILITY

	
21

	 	 
	
Article 11 Term and Termination

	
22

	
11.1   Term

	
22

	
11.2   Cancellation or Termination by OXFORD

	
22

	
11.3   Termination for Cause

	
23

	
11.4   Other Remedies

	
23

	
11.5   Continuing Obligations

	
23

	
11.6   Alternate Remedies

	
23

	 	 
	
Article 12 General Provisions

	
24

	
12.1   Publicity and Advertising

	
24

	
12.2   Amendment

	
24

	
12.3   Assignment and Subcontracting

	
24

	
12.4   Counterparts

	
24

	
12.5   Entire Agreement and Exhibits

	
24

	
12.6   Force Majeure

	
24

	
12.7   Further Acts

	
25

	
12.8   Governing Law

	
25

	
12.9   Sale of Goods

	
25

	
12.10   Notice

	
25

	
12.11   Severability

	
26

	
12.12   Waiver

	
26

	
12.13   Survivorship

	
26

 

 

 

  

ii

  

MANUFACTURING AND CLINICAL TRIALAGREEMENT

 

This  MANUFACTURING AND CLINICAL TRIAL AGREEMENT is made as of this 18th day of December, 2014) (the “Effective Date”) between Tekmira Pharmaceuticals Corporation, on behalf of itself and its wholly owned Affiliate, Protiva Biotherapeutics, Inc. (collectively “Tekmira”), each a B.C. corporation having its principal place of business at 100-8900 Glenlyon Way, Burnaby, B.C.V5J 5J8, Canada, and The Chancellor Masters and Scholars of the University of Oxford (“OXFORD”) whose administrative address is University Offices, Wellington Square, Oxford, OX1 2JD.

 

WHEREAS:

 

	
A.  

	
TEKMIRA is in the business of developing, testing, registering, and commercializing proprietary pharmaceutical products and is the developer of TKM-Ebola, an experimental drug product targeting the Ebola virus.

 

	
B.  

	
OXFORD is established for the advancement of learning by teaching and research and its dissemination by every means; and it undertakes clinical research in relation to the diagnosis, treatment and prevention of disease and the improvement of healthcare.

 

	
C.  

	
OXFORD wishes to conduct an investigator-led clinical trial currently entitled “Rapid Assessment of Potential Interventions & Drugs for Ebola (RAPIDE) – TKM” and wishes to purchase from TEKMIRA, and TEKMIRA wishes to manufacture and supply to OXFORD, TKM-Ebola and associated components for use in such clinical trial to be conducted by OXFORD or its designee in West Africa, all in accordance with the terms and conditions set forth in this Agreement.

 

NOW, THEREFORE, in consideration of the covenants, rights and obligations contained in this Agreement and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

 

Article 1 Interpretation

 

	
1.1  

	
Definitions

 

For the purposes of this Agreement, the following terms will have the meanings set forth below.

 

	
1.1.1  

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

 

	
1.1.2  

	
“Affiliate” means, with respect to any Person, any Persons directly or indirectly controlling, controlled by, or under common control with, such other Person. For purposes hereof, the term “controlled” (including the terms “controlled by” and “under common control with”), as used with respect to any Person, will mean the direct or indirect ability or power to direct or cause the direction of the management and policies of such Person or otherwise direct the affairs of such Person, whether through ownership of securities representing fifty percent (50%) or more of the votes that may be voted at a meeting of shareholders of such Person, by contract or otherwise.

 

	
1.1.3  

	
“Adequate Procedures” has the meaning set out in section 7(2) of the Bribery Act 2010 and any guidance issued under section 9 of that Act.

 

	
1.1.4  

	
“Adverse Reaction” means any untoward and unintended response in a Trial Subject to the Investigational Medicinal Product which is related to any dose administered to that Trial Subject.

 

	
1.1.5  

	
“Agreement” means this Manufacturing and Clinical Trial Agreement and all Exhibits attached hereto.

 

  

1

  

	
1.1.6  

	
“Applicable Requirements” means the terms of this Agreement, the terms of the Ethics Committee Opinion, the Protocol, the terms of the Regulatory Approval, and all applicable laws, regulations, professional standards and good practice (including, where applicable, GCP and cGMP).

 

	
1.1.7  

	
“Arising IP” means any and all Intellectual Property Rights arising from the conduct of the Clinical Trial other than TEKMIRA IP.

 

	
1.1.8  

	
“Associated Person” has the meaning set out in section 8 of the Bribery Act 2010.

 

	
1.1.9  

	
Background IP” means any and all Intellectual Property Rights owned by or licensed to a Party:

 

	 	
(a)

	
existing prior to the date of this Agreement; and/or

 

	 	
(b)

	
developed or acquired independently of this Agreement without use of or reliance upon the Confidential Information of the other Party.

 

	
1.1.10  

	
“Business Day” means any day other than a Saturday, Sunday and statutory holiday in the Province of British Columbia, Canada and in London, England.

 

	
1.1.11  

	
“cGMP” and “current Good Manufacturing Practice” means all applicable principles, guidelines and guidance for current good manufacturing practice as found in:

 

	 	
(a)

	
the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use ICH Tripartite Guideline Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7 (also published as CPMP/ICH/4106/00, 10 November 2000);

 

	 	
(b)

	
the applicable provisions of Directive 2003/94/EC and further guidance as published by the European Commission in Volume 4 of The rules governing medicinal products in the European Union;

 

	 	
(c)

	
foreign equivalents of the foregoing; and

 

	 	
(d)

	
 all other legal provisions, regulations, decisions or guidance of competent authorities which are applicable to any sites involved in the manufacture, quality control, quality assurance or supply of the Investigational Medicinal Product.

 

	
1.1.12  

	
“Chief Investigator” means Dr Peter Horby or any successor appointed by OXFORD in accordance with Section 6.3.1, who shall be the person who takes primary responsibility for the conduct of the Clinical Trial on behalf of OXFORD.

 

	
1.1.13  

	
“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 Arising Intellectual Property.

 

	
1.1.14  

	
“Clinical Samples” means any biological material collected from a Trial Subject in the course of conducting the Clinical Trial.

 

	
1.1.15  

	
“Clinical Trial” means the clinical trial currently entitled “Rapid Assessment of Potential Interventions & Drugs for Ebola (RAPIDE) - TKM” as more fully described in the Protocol.

 

	
1.1.16  

	
“Confidential Information” means all proprietary or confidential information and materials, patentable or otherwise, of a Party or any of its Affiliates which are disclosed by or on behalf of such Party or any of its Affiliates to the other Party under the Non-Disclosure Agreement, or this Agreement and in connection with the Clinical Trial and clearly identified as “confidential” at the time of disclosure (or, if disclosed orally, identified as “confidential” at the time of disclosure and confirmed as such in writing within thirty (30) days of such oral disclosure).

 

  

2

  

	
1.1.17  

	
“Consent Documents” means the information sheet which is to be provided to prospective Trial Subjects and the consent form which is to be signed by Trial Subjects in order to indicate their willingness to participate in the Clinical Trial.

 

	
1.1.18  

	
“Consortium Collaborator” means each of OXFORD’s collaborators for the Clinical Trial, which may include Médecins Sans Frontières (MSF), the World Health Organization (WHO), Institut Pasteur, Institut Pasteur de Dakar, Fondation Mérieux, and such other Person(s) as OXFORD may collaborate with from time to time for purposes of the Clinical Trial.

 

	
1.1.19  

	
“Contingency Fund” shall have the meaning set forth in Section 4.1.3.

 

	
1.1.20  

	
“Damages” means any costs, losses, claims, liabilities, fines, penalties, damages and expenses, court costs, and reasonable fees and disbursements of counsel, incurred by a Party hereto.

 

	
1.1.21  

	
“Data” means all anonymous or pseudonymous information, which is not the product of analysis or interpretation, relating to the clinical findings or observations in the Clinical Trial necessary for the evaluation of the Investigational Medicinal Product, but excludes Safety Information and Trial Subject medical records located at the Trial Sites.

 

	
1.1.22  

	
“Data Controller” has the meaning set out in section 1(1) of the DPA.

 

	
1.1.23  

	
“Deposit” has the meaning set forth at Section 4.1.2.

 

	
1.1.24  

	
“Disclosing Party” has the meaning set out in Section 8.1.3(b).

 

	
1.1.25  

	
“Dollars” and “$” mean the lawful currency of the United States of America.

 

	
1.1.26  

	
“DPA” means the Data Protection Act 1998.

 

	
1.1.27  

	
“DSUR” means a development safety update report, prepared in accordance with applicable law and the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use ICH Harmonized Tripartite Guideline: Development Safety Update Report E2F (17 August 2010).

 

	
1.1.28  

	
“Ethics Committee” means an independent body appointed in accordance with applicable law, whose responsibility is to protect the rights, safety and wellbeing of the Trial Subjects and to provide public assurance of that protection by, among other things, expressing an opinion on the Clinical Trial.

 

	
1.1.29  

	
“Ethics Committee Opinion” means, in relation to the conduct of the Clinical Trial a current and valid favourable opinion expressed by an applicable Ethics Committee, setting out, among other things, the terms and conditions of its approval.

 

	
1.1.30  

	
“FOI Legislation” means the Freedom of Information Act 2000 and the Environmental Information Regulations 2004.

 

	
1.1.31  

	
“Funding” means the funding provided by the Wellcome Trust in support of the Clinical Trial (grant reference 106491/Z/14/Z).

 

	
1.1.32  

	
“GCP”  means all applicable principles, guidelines and guidance for current good clinical practice as found in:

 

  

3

  

	 	
(a)  

	
the Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, adopted by the World Medical Assembly in June 1964, as amended by the General Assembly of the Association in October 1975, October 1983, September 1989, and October 1996. The Parties acknowledge that later amendments have not been accepted under applicable law and are excluded from this Agreement until such time as they are accepted under applicable law;

 

	 	
(b)  

	
the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Tripartite Guideline for Good Clinical Practice E6(R1) (also published as CMP/135/95, 1 July 1996);

 

	 	
(c)  

	
the applicable provisions of the Medicines for Human Use (Clinical Trials) Regulations 2004 and further guidance as published by the UK Medicines and Healthcare products Regulatory Agency;

 

	 	
(d)  

	
the applicable provisions of Directives 2001/20/EC and 2005/28/EC, and further guidance as published by the European Commission in Volume 10 of The rules governing medicinal products in the European Union; and;

 

	 	
(e)  

	
all other legal provisions, regulations, decisions or guidance of competent authorities which are applicable to the conduct of the Clinical Trial.

 

	
1.1.33  

	
“Indemnified Person” means a TEKMIRA Indemnitee or an OXFORD Indemnitee.

 

	
1.1.34  

	
“Infusion Kit” means the infusion kit to be used for the administration of Investigational Medicinal Product and having the components described in Exhibit 1.1.34.

 

	
1.1.35  

	
“Intellectual Property” means the patents, patent applications, including without limitation, Arising IP, TEKMIRA Arising IP, utility, model and design patents and certificates of invention and all divisionals, continuations, continuations-in-part, reissues, renewals, extensions (including supplemental protection certificates), additions, registrations or confirmations to or of any such patent applications and patents, trade names, trademarks, copyright, trade secrets, trade dress, industrial and other designs, trade secrets, improvements, Know-How, and other forms of intellectual property, all whether or not registered or protected, or capable of such registration or protection.

 

	
1.1.36  

	
“Investigational Medicinal Product Dossier” means TEKMIRA’s dossier on each Investigational Medicinal Product to be used in the Clinical Trial, compiled in accordance with applicable law and submitted by TEKMIRA to the United States Food and Drug Administration or any successor agency thereof (“FDA”) in support of an application for Regulatory Approval.

 

	
1.1.37  

	
“Investigator” means a person (including, if applicable, the Chief Investigator) responsible for the conduct of the Clinical Trial at a Trial Site and, if the Clinical Trial is conducted by a team of persons at a Trial Site, the person responsible for that team.

 

	
1.1.38  

	
“Investigational Medicinal Product” means TKM-Ebola presented in wet format, targeting the Guinea variant of the Ebola virus having the product description set forth in Exhibit 1.1.38.

 

	
1.1.39  

	
“Investigator Brochure” means the investigator brochure provided by TEKMIRA containing a detailed description of the Investigational Medicinal Product’s chemical structure and siRNA sequence, and a summary of the clinical and non-clinical data related to TKM-Ebola provided by TEKMIRA prior to the commencement of the Clinical Trial, as well as any revisions thereto that may be delivered during the course of the Clinical Trial.

 

  

4

  

	
1.1.40  

	
“Know-How” means, to the extent not generally known, any and all non-patentable technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, procedures, practices, formulas, instructions, skills, and/or techniques (however recorded or preserved).

 

	
1.1.41  

	
“Manufacture” or “Manufacturing” means, with respect to the Investigational Medicinal Product, all or a portion of the activities associated with the production and processing of such Investigational Medicinal Product, including without limitation, project planning, procurement of components, consumables and/or raw materials, vendor qualification, batch record development, manufacture, quality control testing, quality assurance, storage and shipping.

 

	
1.1.42  

	
“Non-Disclosure Agreement” means the Non-Disclosure Agreement dated effective August 19, 2014 between TEKMIRA and the International Severe Acute Respiratory and Emerging Infection Consortium at OXFORD.

 

	
1.1.43  

	
“OXFORD Indemnitee” has the meaning set forth in Section 10.2.

 

	
1.1.44  

	
“OXFORD Protocol” and “Protocol” means the protocol to be used in the Clinical Trial, which protocol may be based in whole or in part on the TEKMIRA Protocol.  For avoidance of doubt, all references to the term “Protocol” shall mean the OXFORD Protocol.

 

	
1.1.45  

	
“Party” means OXFORD or TEKMIRA, and “Parties” means OXFORD and TEKMIRA.

 

	
1.1.46  

	
“Person” means a natural person, corporation, partnership, trust, joint venture, limited liability company, non-governmental organization, or any other legal entity.

 

	
1.1.47  

	
“Personal Data” has the meaning set out in section 1(1) of the DPA and relates only to Personal Data, or any part of such Personal Data, of which OXFORD is a Data Controller and which it has obtained in the course of conducting the Clinical Trial.

 

	
1.1.48  

	
“Personnel” means the Chief Investigator and any Investigator or other individuals involved in the conduct of the Clinical Trial, whether or not employed by OXFORD.

 

	
1.1.49  

	
“Pharmacovigilance” means the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other drug-related problem, or any updated definition published by the World Health Organization from time to time.

 

	
1.1.50

	
 “Tekmira Protocol” means TEKMIRA’s treatment protocol entitled “Treatment Protocol for Use of TKM-130803 Injection in Patients with Confirmed or Suspected Ebola Virus Infection” provided by TEKMIRA to OXFORD.

 

	
1.1.51  

	
“Receiving Party” has the meaning set out in Section 8.1.3(b).

 

	
1.1.52  

	
“Regulatory Approval” means, in relation to the conduct of the Clinical Trial, any current and valid grant, renewal, validation, authorization, certificate and/or registration of a Regulatory Authority required under applicable law.

 

	
1.1.53  

	
“Regulatory Authorities” means the United States Food and Drug Administration or any successor agency thereof (“FDA”), the European Medicines Agency (“EMA”) and any other like governmental authorities in West Africa regulating the importation, distribution, and/or use of therapeutic substances.

 

	
1.1.54  

	
“Relevant Requirements” means all applicable laws relating to anti-bribery and anti-corruption, including the Bribery Act 2010, in connection with a Party’s conduct under this Agreement.

 

  

5

  

	
1.1.55  

	
“Representatives” means, with respect to TEKMIRA, its Affiliate and their respective directors, officers, employees, consultants, advisors, contractors and agents; and with respect of OXFORD, each Consortium Collaborator and their respective directors, officers, employees, consultants, advisors, contractors and agents (including, where appropriate, students).  For clarity, “Representatives” includes “Personnel” as defined above.

 

	
1.1.56  

	
“Regulatory Support” means (a) the design and performance of stability studies for the Investigational Medicinal Product, and (b) the updating of Investigational Medicinal Product regulatory filings with data generated from said stability studies.

 

	
1.1.57  

	
 “Results” means any and all discoveries, theories, Know-How, computer software, notes, chemical compounds, biological material, models, prototypes, drawings, information, Data, analyses, case report forms, analytical results, interpretations, results and reports (other than Trial Subject medical records located at the Trial Sites) generated in the course of conducting the Clinical Trial, whether preliminary or final.

 

	
1.1.58  

	
“Safety Information” means all filings, submissions and reports concerning the safety of the Investigational Medicinal Product or Pharmacovigilance with or to any Regulatory Authority or Ethics Committee, or a body designated or recognized by any Regulatory Authority or Ethics Committee for such purposes.

 

	
1.1.59  

	
“Service Fees” means the fees in US Dollars to be paid by OXFORD to TEKMIRA for the provision of Services as more fully described in Section 4.1.

 

	
1.1.60  

	
“Services” means the (a) Manufacture and supply of cGMP grade Investigational Medicinal Product sufficient to provide a full treatment course to one hundred (100)  patients based on estimated batch yield and clinical dose as dictated by body weight, (b) supply of approximately one hundred (100) single use Infusion Kits necessary for gravity fed intravenous infusion, (c) Regulatory Support, and (d) provision of a TEKMIRA Protocol, Investigator Brochures, and instructions for the handling and storage of Investigational Medicinal Product and for the use of Infusion Kits.

 

	
1.1.61  

	
“Sponsor” means OXFORD, as the Party taking responsibility for the initiation, management and financing (or arranging the financing) of the Clinical Trial, and the regulatory responsibilities which accompany the role.

 

	
1.1.62  

	
“TEKMIRA Arising IP” means (a) any and all Arising IP relating directly to any development of the Investigational Medicinal Product that would, if practiced, infringe TEKMIRA’s Background IP in the Investigational Medicinal Product and (b) all improvements and/or modifications directed to Tekmira IP regardless of the Representative making such improvements and/or modifications.

 

	
1.1.63  

	
“TEKMIRA Confidential Information” means the TKEMIRA Protocol, Investigator Brochure, TEKMIRA IP, TEKMIRA Arising IP, stability study design, data and results, and any part or whole of the sum of all images, data, records, reports, charts, information and documentation in physical, electronic or other form which are comprised of and/or derived from Confidential Information, Intellectual Property and/or materials disclosed or provided by or on behalf of TEKMIRA.

 

	
1.1.64  

	
“TEKMIRA Indemnitee” has the meaning set forth in Section 10.1.

 

	
1.1.65  

	
“TEKMIRA IP” means (a) all materials, information and Confidential Information disclosed and/or supplied by TEKMIRA or its Representatives to OXFORD or OXFORD’s Representatives, and (b) all patents and patent applications owned or controlled by TEKMIRA whether or not disclosed to OXFORD.

 

	
1.1.66  

	
“Term” shall have the meaning set forth in Section 11.1.

 

  

6

  

	
1.1.67  

	
“Trial Site” means any hospital, health centre, clinic, surgery or other establishment, treatment center or facility where the trial or any part of it is carried out.

 

	
1.1.68  

	
“Trial Site Agreement” means the agreement entered into between OXFORD and each Trial Site (or the legal entity controlling the Trial Site) to govern the activities to be performed at that Trial Site in accordance with the Protocol.

 

	
1.1.69  

	
Trial Subject” means an individual, whether a patient or not, who participates in the Clinical Trial:

 

	 	
(a)  

	
as a recipient of the Investigational Medicinal Product or of some other treatment or product; or

 

	 	
(b)  

	
without receiving any treatment or product, as a control.

 

	
1.1.70  

	
“Wellcome Trust” shall mean the UK charity who are providing funding to OXFORD in support of the Clinical Trial (including in support of the Services provided under this Agreement).

 

Article 2 Engagement

 

	
2.1  

	
Appointment of TEKMIRA

 

OXFORD hereby engages TEKMIRA to provide Services and Regulatory Support to facilitate the conduct of the Clinical Trial, at OXFORD’s sole cost and expense.  TEKMIRA hereby agrees to perform the Services and provide the Regulatory Support in accordance with the estimated time frames set forth in Exhibit 2.1.  TEKMIRA shall commence procurement of raw materials and components within one (1) Business Day of TEKMIRA’s receipt of the Deposit.

 

	
2.2  

	
Change Orders

 

If OXFORD desires to change any aspect of the Services, including, without limitation, any change to the variant of the Ebola virus to be targeted or the quantity of Investigational Medicinal Product to be delivered, OXFORD shall notify TEKMIRA in writing as soon as reasonably possible setting forth the nature of such change.  TEKMIRA shall respond in writing as soon as reasonably possible to inform what effect, if any, such required change may have on the Service Fees, time frame or other parameter governing the delivery of Services, and the Parties shall make good faith efforts to execute a mutually agreeable change order (“Change Order”) as soon as reasonably possible.  No Change Order will be effective unless and until it has been signed by an authorized officer of each Party.  If agreed between the Parties, TEKMIRA shall continue to provide Services during the Parties’ investigation or negotiation of such Change Order, provided such efforts would facilitate the completion of the work envisioned in the proposed Change Order.

 

	
2.3  

	
OXFORD performance of the Clinical Trial

 

	
2.3.1

	
It is the intention that OXFORD shall be the Sponsor of Clinical Trials utilizing the Investigational Medicinal Product, subject to obtaining all required approvals and in accordance with applicable law and regulatory requirements.  If OXFORD is not the Sponsor, TEKMIRA shall have the right to either approve the assignment of this Agreement by OXFORD, or enter into a Clinical Trial Agreement with the sponsor of the Clinical Trial. OXFORD shall use its best efforts to conduct the Clinical Trial in accordance with the Applicable Requirements.

 

	
2.3.2

	
Although Oxford will conduct any Clinical Trials in accordance with 2.3.1, the Parties acknowledge and agree that Oxford does not undertake that any work carried out under or pursuant to this Agreement will lead to any particular result, nor is the success of such work guaranteed.

 

  

7

  

	
2.4  

	
TEKMIRA performance of Clinical Trial activities

 

	
2.4.1

	
To the extent that OXFORD delegates any activity to TEKMIRA under this Agreement for which OXFORD has regulatory responsibility under applicable law, TEKMIRA shall carry out such regulatory activity in accordance with the Applicable Requirements. The following activities are hereby delegated to TEKMIRA:

 

(a)           the Manufacture and supply of the Investigational Medicinal Product and the Infusion Kit;

 

(b)           the preparation and supply of the Investigator’s Brochure;

 

(c)           the preparation and supply of the Investigational Medicinal Product Dossier;

 

(d)           the preparation and supply of the DSUR.

 

 

Article 3  Manufacturing Services

 

	
3.1  

	
Use of Materials and Investigational Medicinal Product

 

OXFORD agrees that it shall use all reasonable endeavours to:

 

	
3.1.1  

	
control and use Investigational Medicinal Product, Infusion Kits and TEKMIRA Confidential Information in compliance with this Agreement;

 

	
3.1.2  

	
use Investigational Medicinal Products, Infusion Kits and TEKMIRA Confidential Information solely in the performance of the Clinical Trial and for no other purpose whatsoever;

 

	
3.1.3  

	
except with the prior written consent of TEKMIRA not distribute or release any Investigational Medicinal Product, Infusion Kits, TEKMIRA Confidential Information or TEKMIRA IP, to any Person other than those Persons who require access to same for the conduct of the Clinical Trial, unless to any Regulatory Authorities as part of a statutory request, in which latter case, OXFORD shall promptly notify TEKMIRA in writing of such request;

 

	
3.1.4  

	
not duplicate or reverse engineer, or in any other way attempt to determine the identity, chemical composition or sequence of the Investigational Medicinal Product; and

 

	
3.1.5  

	
inform each Consortium Collaborator in writing of their obligation to comply with this Section 3.1.

 

	
3.2  

	
Storage

 

OXFORD shall use all reasonable endeavours to maintain (or procure that the same are maintained at Trial Sites) adequate facilities for the storage of Investigational Medicinal Product and Infusion Kits, store Investigational Medicinal Product in accordance with the storage and handling specifications, and maintain handling and storage records pertaining thereto.

 

	
3.3  

	
Transport and Risk of Loss

 

	
3.3.1  

	
TEKMIRA will package, label and ship the Investigational Medicinal Product using TEKMIRA’s standard shipping, packaging and labeling procedures, which labeling procedures shall conform with FDA requirements, and shall ship Investigational Medicinal Product to the address specified in the Shipping Details (as defined in Exhibit 3.3.1), in accordance with TEKMIRA’s packing and shipping specifications.  Shipment will be DAP (Incoterms 2010) and subject to the provisions of Exhibit 3.3.1.

 

  

8

  

	
3.3.2  

	
TEKMIRA shall purchase sufficient insurance coverage for fire and related perils in respect of property damage for replacement value for the period of time during which raw materials and components funded by the Deposit is located at TEKMIRA’s facilities, which coverage includes, amongst other things, accidental damage, malicious damage, and fire.

 

	
3.4  

	
Reporting and Records

 

In order to enable TEKMIRA to comply with its regulatory obligations to Regulatory Authorities worldwide:

 

	
3.4.1  

	
OXFORD will keep TEKMIRA advised of the status of the Clinical Trial through regular telephone conversations and E-mails and will share with TEKMIRA in a timely manner, all Results and observations made during the Clinical Trial.  OXFORD shall have the right to remove all patient identifiers prior to disclosure of any Results in accordance with the DPA and other privacy laws.  In the event of a serious adverse event, OXFORD shall notify TEKMIRA immediately, but in no case more than twenty-four (24) hours following the occurrence of such serious adverse event.

 

	
3.4.2  

	
OXFORD will keep complete and accurate written records of the status and progress of each patient in the Clinical Trial in accordance with the OXFORD Protocol and on the receipt and disposition of Investigational Medicinal Product, and make same available to TEKMIRA upon TEKMIRA’s reasonable request subject to OXFORD’s right to remove all patient identifiers prior to disclosure in accordance with the DPA and other privacy laws.   For the purposes of the communications contemplated in this Section 3.4, OXFORD’s primary contact shall be Dr. Peter Horby, and TEKMIRA’s primary contact shall be Dr. Mark Kowalski.

 

Article 4 Compensation

 

	
4.1  

	
[***]

 

	
4.1.1  

	
[***].

 

	
4.1.2  

	
 
Within three (3) Business Days of the Effective Date, OXFORD shall pay to TEKMIRA a deposit (the “Deposit”) of One Million and Ninety-Eight Thousand U.S. Dollars (US$_1,098,000.00). The Deposit shall, subject to Section 11.2.2, be non-refundable, except where TEKMIRA fails to deliver the Investigational Medicinal Product and Infusion Kits by the estimated shipping dates set forth in Exhibit 3.3.1.

 

	
4.1.3  

	
[***].

 

	
4.1.4  

	
[***].

 

	
4.1.5  

	
[***].

 

	
4.1.6  

	
[***].

 

	
4.2  

	
Future Development and Use of the Investigational Medicinal Product

 

If the Investigational Medicinal Product is shown to be safe and efficacious, TEKMIRA agrees that it shall use reasonable endeavors to, through itself of its designees, (a) make the Investigational Medicinal Product available for further research purposes (in so far as production capacity allows) to evaluate the use of the Investigational Medicinal Product in patients with Ebola Virus Disease including investigations of safety and efficacy; (b) seek registration of the Investigational Medicinal Product for use in patients with Ebola Virus Disease with appropriate regulatory authorities; and (c) make the Investigational Medicinal Product available for procurement by relevant parties, international agencies, and/or governments of any country classified as a low or lower middle income country by the Organization for Economic Co-operation and Development affected by Ebola Virus Disease in sufficient quantities to meet demand (in so far as production capacity allows) [***].

 

  

9

  

Article 5 Regulatory Compliance, Support and Responsibilities

 

	
5.1  

	
Anti-Bribery

 

	
5.1.1  

	
Each Party shall:

 

	 	
(a)

	
comply with all Relevant Requirements;

 

	 	
(b)

	
have and shall maintain in place throughout the Term its own policies and procedures, including Adequate Procedures under the Relevant Requirements, to ensure compliance with the Relevant Requirements and will enforce them where appropriate; and

 

	 	
(c)

	
promptly report to the other Party any request or demand for any undue financial or other advantage of any kind received by it in connection with this Agreement.

 

	
5.1.2  

	
Each Party shall ensure that any Associated Person who it involves in the performance of any obligations under this Agreement and/or the provision of support services does so only on the basis of a written agreement which imposes on and secures from such Associated Person terms equivalent to those imposed on the Parties under this Section 5.1.

 

	
5.1.3  

	
The Parties acknowledge and agree that any breach of this Section 5.1 (however trivial) shall be deemed to be an irremediable material breach of this Agreement.

 

	
5.2  

	
Clinical Samples

 

	
5.2.1  

	
 All Clinical Samples shall, unless otherwise agreed in writing, be held under the custodianship of OXFORD with any storage and transfer to be always in accordance with all Applicable Requirements. OXFORD shall exercise its rights and duties as custodian of the Clinical Samples in accordance with the relevant Trial Subject Consent Documents, any relevant Ethics Committee Opinion, Applicable Requirements and this Section 5.2.

 

	
5.2.2  

	
All use of the Clinical Samples, other than for the purposes of the Clinical Trial, shall be subject to a determination as to the safety and scientific validity of the proposed use of the Clinical Samples (taking into account the quantity of the Clinical Samples available). The final decision in relation to such use shall be taken by OXFORD, as custodian of the Clinical Samples, always in accordance with the Trial Subject Consent Documents and all Applicable Requirements.

 

	
5.3  

	
Regulatory Support

 

	
5.3.1  

	
TEKMIRA will be responsible for (a) designing and implementing stability study protocols for the testing of Investigational Medicinal Product and reporting out-of-specification results, if any, to OXFORD during the duration of the Clinical Trial; and (b) updating TEKMIRA’s regulatory filings for the Investigational Medicinal Product with all results generated in the performance of the stability studies.  Parameters for the stability study design are set forth in Exhibit 5.3.1 attached hereto.

 

	
5.4  

	
Responsibilities

 

	
5.4.1  

	
TEKMIRA will be responsible for maintaining and fulfilling all cGMP requirements that are imposed upon TEKMIRA as the Manufacturer of the Investigational Medicinal Product.

 

	
5.4.2  

	
OXFORD will be responsible for (a) obtaining and maintaining all applicable permits (including informed patient consent), licenses and such approvals to the extent necessary for the conduct of the Clinical Trial, and (b) complying with all applicable GCPs as well as local government laws and regulations in the conduct of the Clinical Trial.

 

  

10

  

	
5.5  

	
Records, Audits and Inspections

 

	
5.5.1  

	
Each Party shall maintain records in relation to the conduct of the Clinical Trial (appropriate to its role and responsibilities under this Agreement) in accordance with GCP and applicable law; and the Parties shall retain such records for the later of fifteen (15) years from the conclusion of the Clinical Trial (however determined) or such longer period of time as may be required by applicable law, including the record retention requirements of the United States Food and Drug Administration.

 

	
5.5.2  

	
Each Party shall allow an independent auditor, appointed by mutual written agreement of the Parties, during normal working hours and upon reasonable written notice to inspect that portion of its facilities and records solely for the purpose of auditing the Party’s compliance with GCP, GMP and applicable law in relation to the manufacture and supply of the Investigational Medicinal Product and/or the conduct of the Clinical Trial. Any such auditor shall be accompanied by personnel of the audited Party at all times, shall be qualified to conduct such audits and shall comply with all applicable rules and regulations relating to facility security and health and safety.

 

	
5.5.3  

	
Each Party shall make its facilities and records available for inspection by representatives of any Regulatory Authority in compliance with all applicable laws. A Party shall notify the other Party within three (3) days of its receipt of any correspondence, notice or any other indication whatsoever of Regulatory Authority inspection, investigation or other inquiry, or other notice or communication from any Regulatory Authority of any type, that could reasonably be expected to affect the manufacture and supply of the Investigational Medicinal Product and/or the conduct of the Clinical Trial in a material way.

 

	
5.5.4  

	
To the extent that any inspection, investigation or other inquiry pursuant to Section 5.5.3 concerns the Investigational Medicinal Product supplied, or to be supplied, or the conduct of the Clinical Trial, the affected Party shall invite and allow representatives of the other Party to be present during the applicable portions of any such inspection, investigation or other inquiry.  The affected Party shall consult with the other Party with respect to any response to observations and notifications received in connection with any such inspection, investigation or other inquiry and will give the other Party an opportunity to comment upon (which comments shall be considered by the affected Party in good faith) any proposed response before it is submitted; provided, however, that TEKMIRA shall not be required to disclose to or consult with OXFORD regarding any manufacturing or equipment specifications, processes, methods or Know-How covering the Investigational Medicinal Product.

 

	
5.6  

	
Variation

 

In the event that:

 

	
5.6.1  

	
any Regulatory Authority requires a Party to implement any changes to the Clinical Trial that affects this Agreement;

 

	
5.6.2  

	
any Ethics Committee requires a Party to implement any changes to the Clinical Trial that affects this Agreement;

 

	
5.6.3  

	
any changes to this Agreement are required in order to comply with changes to applicable law; or

 

	
5.6.4  

	
any Party, in its reasonable opinion, considers it to be necessary to change this Agreement to ensure: (a) the safety of Trial Subjects; (b) the scientific validity of the Clinical Trial; or (c) that the conditions and principles of GCP and/or cGMP are satisfied or adhered to in relation to the Clinical Trial

 

  

11

  

the Parties shall not unreasonably withhold or delay agreement to such change or its implementation; nor shall a Party impose unreasonable conditions (having regard to the other terms of this Agreement) in implementing the change.  Any revision to the Service Fees required by a variation pursuant to this Section shall (to the extent possible) be calculated using the same or an equivalent method to that which was used to calculate the Service Fees prior to such change.

 

Article 6 Clinical Trial

 

	
6.1  

	
Protocol Development

 

	
6.1.1  

	
OXFORD and TEKMIRA will mutually agree upon the OXFORD Protocol, which will be designed utilizing the TEKMIRA Protocol for instructions related to Product administration.

 

	
6.1.2  

	
Once the parties have mutually agreed upon the OXFORD Protocol, if OXFORD wishes to make further changes to the OXFORD Protocol after TEKMIRA’s approval has been granted, TEKMIRA shall again have the right receive, review, comment and approve in writing each new change.  In this latter case, TEKMIRA may only withhold approval of the OXFORD Protocol for reasons relating to patient safety or data integrity, as determined by changes in mode or rate of drug administration, dosage, method of tracking and/or reporting patient adverse events, frequency or nature of safety monitoring, inclusion criteria, exclusion criteria, use of concomitant medications, randomization, stopping rules, use of placebo, or other elements relating to patient care.

 

	
6.1.3  

	
TEKMIRA may, subject to Section 11.3.6 (return of Wellcome Trust funding), decline to ship Investigational Medicinal Product and terminate this Agreement in the event that the OXFORD Protocol or any further change thereto is not approved by TEKMIRA.  If after shipment of the Investigational Medicinal Product, the OXFORD Protocol or any further change thereto is not approved by TEKMIRA, the Parties shall mutually terminate the Agreement, and subject to Section 11.3.6 (return of Wellcome Trust funding) OXFORD shall promptly return all Investigational Medicinal Product to TEKMIRA or destroy same and confirm destruction in writing, at TEKMIRA’s sole election.

 

	
6.2  

	
Conduct of Clinical Trial

 

	
6.2.1  

	
The Parties acknowledge and agree that OXFORD shall be the Sponsor of the Clinical Trial.

 

	
6.2.2  

	
Nothing in this Agreement shall prevent OXFORD or its Representatives from taking appropriate urgent measures (including, if reasonably appropriate, suspension of the Clinical Trial) in order to protect Trial Subjects against any immediate hazard to their health or safety. If such measures are taken by OXFORD or its Representatives, it shall as soon as reasonably practicable give written notice to TEKMIRA of the measures taken and the circumstances giving rise to those measures.

 

	
6.2.3  

	
Although OXFORD will conduct the Clinical Trial in accordance with Section 6.2.2 the Parties acknowledge and agree that OXFORD does not undertake that any work carried out under or pursuant to this Agreement will lead to any particular result, nor is the success of such work guaranteed.

 

	
6.2.4  

	
TEKMIRA shall provide to OXFORD such information and cooperation as OXFORD may reasonably request to enable OXFORD to conduct the Clinical Trial.

 

	
6.3  

	
Personnel

 

	
6.3.1  

	
OXFORD shall use its reasonable endeavours to retain the services of the Chief Investigator during the Term; and to ensure that all Personnel are appropriately qualified by education, training and experience to perform the tasks given to them.

 

  

12

  

	
6.3.2  

	
OXFORD shall use its reasonable endeavours to ensure that the Chief Investigator does not, during the Term, conduct any other clinical trial which might adversely affect OXFORD’s ability to perform its obligations under this Agreement.

 

	
6.3.3  

	
OXFORD shall promptly notify TEKMIRA if at any time during the Term the Chief Investigator is unable or unwilling to continue the direction or supervision of the Clinical Trial. Within sixty (60) days after such incapacity or expression of unwillingness, OXFORD shall nominate a successor to be the Chief Investigator. TEKMIRA shall not unreasonably decline to accept the nominated successor, but if the successor is not acceptable to TEKMIRA on reasonable and substantial grounds, then either Party may terminate this Agreement on ninety (90) days’ written notice to the other Party.

 

	
6.4  

	
Ethical and Regulatory Approvals

 

	
6.4.1  

	
OXFORD and the Chief Investigator shall, subject to Section 6.4.2, be responsible for obtaining all necessary Ethics Committee Opinions and Regulatory Approvals. OXFORD shall provide to TEKMIRA written status reports on such applications at reasonable intervals.

 

	
6.4.2  

	
TEKMIRA shall, in relation to the Investigational Medicinal Product, be responsible for compiling the Investigational Medicinal Product Dossier.  TEKMIRA shall grant OXFORD, permission to provide the applicable Regulatory Authorities reference access to TEKMIRA’s Investigational Medicinal Product Dossier in a timely manner sufficient to meet OXFORD’s obligations under this Agreement.

 

	
6.4.3  

	
The Parties acknowledge and agree that OXFORD cannot: (a) start the Clinical Trial or cause the Clinical Trial to be started; or (b) conduct the Clinical trial; unless the conditions set out in Section 6.4.4 have been satisfied.

 

	
6.4.4  

	
The conditions referred to in Section 6.4.3 are:

 

	 	
(a)  

	
the receipt of the relevant Ethics Committee Opinion by OXFORD; and

 

	 	
(b)  

	
the receipt of the Regulatory Approval by OXFORD.

 

	
6.5  

	
Trial Sites

 

	
6.5.1  

	
OXFORD shall enter into Trial Site Agreements which set out the terms under which OXFORD as Sponsor and each Trial Site shall collaborate in the performance of the Clinical Trial.

 

	
6.5.2  

	
The Parties acknowledge that it may not be possible to accurately forecast the recruitment of Trial Subjects, and that the number of Trial Sites may need to be reviewed from time to time.

 

	
6.5.3  

	
OXFORD shall use its reasonable endeavours to select Trial Sites and Investigators who are experienced in, or shall be trained in, the conduct of clinical trials in the therapeutic field relevant to the Clinical Trial. OXFORD shall provide to TEKMIRA written status reports on the Trial Sites appointed by OXFORD at reasonable intervals.

 

	
6.5.4  

	
The responsibilities of a Trial Site are detailed in the Protocol and shall be further detailed in the applicable Trial Site Agreement, which shall be consistent with the terms of this Agreement and impose consistent obligations on the Trial Sites.

 

	
6.6  

	
Data Protection

 

	
6.6.1  

	
The Parties acknowledge and agree that, notwithstanding any other provision contained in this Agreement, OXFORD shall not, and shall procure that any Representative of OXFORD does not, disclose any Personal Data of a Trial Subject to TEKMIRA, except where strictly necessary and where permitted by applicable law (including the DPA).

 

  

13

  

	
6.6.2  

	
TEKMIRA undertakes, not to identify, or attempt to identify, a Trial Subject from any information supplied to it by OXFORD or its Representatives under this Agreement.

 

	
6.6.3  

	
The Parties shall (and shall ensure that their respective Representatives shall) comply with the requirements of the DPA (and related legislation) in conducting the Clinical Trial or otherwise in connection with this Agreement.

 

	
6.7  

	
Pharmacovigilance

 

	
6.7.1  

	
OXFORD, as Sponsor, shall be responsible for reporting all Safety Information in relation to the Clinical Trial to the Regulatory Authority and/or the Ethics Committee in accordance with applicable law.

 

	
6.7.2  

	
OXFORD shall report all Safety Information in relation to the Clinical Trial to TEKMIRA as soon as reasonably practicable and, in any event, not later than the date on which OXFORD reports any such Safety Information to the Regulatory Authority or, as the case may be, the Ethics Committee.

 

	
6.7.3  

	
OXFORD shall, as soon as reasonably practical, during and after the conclusion of the Clinical Trial (however determined), provide TEKMIRA with access to all Safety Information and other data relating to Adverse Reactions (collected in accordance with the Protocol) in relation to the Clinical Trial (including the right to make copies) to the extent necessary for TEKMIRA’s preparation of the DSUR and for regulatory purposes only.

 

	
6.7.4  

	
TEKMIRA shall, during the Term, promptly report to OXFORD all Safety Information relating to other clinical trials that test or use the Investigational Medicinal Product which it has contributed to the Clinical Trial and for which OXFORD is not the Sponsor.

 

	
6.7.5  

	
TEKMIRA shall, in relation to the Investigational Medicinal Product, be responsible for compiling the DSUR during the Term and thereafter in relation to the DSUR required at the end of the then current reporting year.  TEKMIRA shall provide each DSUR to OXFORD in a timely manner sufficient to meet OXFORD’s obligations under applicable law.

 

	
6.8  

	
Insurance

 

OXFORD, as Sponsor,  shall have, and maintain in place for the Term and for a period of five years thereafter, an insurance policy to provide legal liability compensation for injury caused to a Trial Subject by participation in this Clinical Trial. TEKMIRA confirms that it shall have, and maintain in place for the Term and for a period of five years thereafter, adequate insurance related to its liabilities under this Agreement, in particular as regards the Manufacture and supply of the Investigational Medicinal Product.

 

Article 7 Intellectual Property

 

	
7.1  

	
Background IP

 

	
7.1.1  

	
Nothing in this Agreement shall affect the ownership of any Background IP.  Without limiting the generality of the foregoing, OXFORD acknowledges and agrees that all materials, information and Confidential Information disclosed and/or supplied by TEKMIRA or its Representatives to OXFORD or OXFORD’s Representatives are the exclusive property of TEKMIRA (collectively, “TEKMIRA IP”) and that TEKMIRA shall retain all right, title and interest, including all Intellectual Property rights in and to such TEKMIRA IP.

 

  

14

  

	
7.1.2  

	
Each Party grants to the other Party a non-exclusive, worldwide, royalty-free license under its Background IP solely to the extent provided by a Party for use within the Clinical Trial and necessary for the other Party to perform its obligations under this Agreement. The license granted under this Section 7.1.2 shall be sub-licensable solely to the extent necessary for the conduct of the Clinical Trial in accordance with this Agreement.

 

	
7.2  

	
Arising IP

 

	
7.2.1  

	
All Arising IP shall be owned by OXFORD, except that all TEKMIRA Arising IP shall be owned by TEKMIRA.

 

	
7.2.2  

	
OXFORD shall disclose in writing to TEKMIRA all TEKMIRA Arising IP of which OXFORD becomes aware, promptly but no later than fourteen (14) days following OXFORD becoming aware of same and shall assign and cause its Representatives to assign to TEKMIRA without additional consideration, all right, title and interest in and to TEKMIRA Arising IP.

 

	
7.2.3  

	
OXFORD hereby grants to TEKMIRA, subject to Section 7.2.4, a non-exclusive, worldwide, perpetual, fully paid-up, royalty-free, sublicensable license under all Arising IP conceived or reduced to practice by OXFORD or its Representatives, for its own internal research and regulatory filings.  If this Agreement is terminated for TEKMIRA’s material breach, this licensee will automatically terminate.

 

	
7.2.4  

	
Subject to TEKMIRA calling for (in writing) and completing a license agreement within six months after the completion of the Clinical Trial (or by such other date as the Parties may agree), the OXFORD is willing to grant to TEKMIRA a license to make, have made, use and market products and services derived from the Arising IP. Subject to Section 7.2.6, the license would be exclusive. Under such license, TEKMIRA would agree to pay:

 

	 	
(a)  

	
a reasonable proportion of all up front, milestone and other payments received by TEKMIRA and attributable in whole or in part to Arising IP;

 

	 	
(b)  

	
reasonable royalties based on the net selling prices of all licensed products (that is to say, all products and services marketed by TEKMIRA or TEKMIRA’s sub-licensees and derived from, produced by, or containing Arising IP); and

 

	 	
(c)  

	
reasonable royalties on any cross licensing and other non-monetary compensation received by TEKMIRA from the exploitation of Arising IP.

 

The remaining terms of the license would be settled between the Parties in good faith negotiations: if at any point they were unable to agree, the point in dispute would be settled in London by an arbitrator. The arbitrator would be a barrister specializing in intellectual property law, who had no prior association with either Party or was otherwise acceptable to both Parties. He or she would be nominated for the purpose by the then Chairman of the General Council of the Bar. OXFORD may fulfil its obligations under Section 7.2.4 through its technology transfer company, Isis Innovation Limited, and may take such actions (including in respect of the Arising IP) as may be necessary or desirable for this purpose.

 

	
7.2.5  

	
TEKMIRA hereby grants to OXFORD and each Consortium Collaborator, a non-exclusive, worldwide, perpetual, fully paid-up, royalty-free, sublicensable license under all TEKMIRA Arising IP (a) during the Clinical Trial, and (b) for any future administration of Investigational Medicinal Product supplied by TEKMIRA or TEKMIRA’s licensees or designees.  If this Agreement is terminated for OXFORD’s material breach, this licensee will automatically terminate.

 

	
7.2.6  

	
The University and its Representatives shall have the irrevocable right in perpetuity to use any and all Arising IP for Academic and Research Purposes and for the purpose of Clinical Patient Care.

 

  

15

  

	
7.3  

	
Perfection of Ownership Rights

 

	
7.3.1  

	
OXFORD agrees to and shall cause each Consortium Collaborator to:

 

	 	
(a)  

	
report to TEKMIRA all TEKMIRA Arising IP created, conceived or reduced to practice by it or its Representatives as a result of conducting the Clinical Trial within fourteen (14) days of becoming aware of such discoveries or inventions;

 

	 	
(b)  

	
cooperate and cause its Representatives to cooperate with TEKMIRA, at TEKMIRA’s expense, in perfecting TEKMIRA’s ownership and other proprietary rights in respect of any TEKMIRA Arising IP to which TEKMIRA is entitled pursuant to this Article 7; and

 

	 	
(c)  

	
execute, assign and deliver, and cause its Representatives to execute, assign and deliver to TEKMIRA, at TEKMIRA’s expense, any documents and any other instruments of conveyance and transfer that TEKMIRA may reasonably require with respect to TEKMIRA’s rights to TEKMIRA Arising IP under this Article 7.

 

Article 8 Confidentiality

 

	
8.1  

	
Confidentiality Obligations

 

	
8.1.1  

	
OXFORD acknowledges and agrees that (a) all information provided by TEKMIRA in confidence to OXFORD or OXFORD’s Representatives under the Non-Disclosure Agreement constitutes TEKMIRA Confidential Information for the purposes of this Agreement, and (b) the provisions of this Article 8 shall apply to all TEKMIRA Confidential Information received by OXFORD or its Representatives on or after the effective date of the Non-Disclosure Agreement.

 

	
8.1.2  

	
Each Party (the “Receiving Party”) will keep all Confidential Information received from the other Party (the “Disclosing Party”) in confidence for a period of seven (7) years from the date of receipt thereof and will not, without the Disclosing Party’s prior written consent, disclose any of the Disclosing Party’s Confidential Information to any person or entity, except to those of its Representatives who (i) require such Confidential Information for the performance of this Agreement or the conduct of the Clinical Trial, (ii) are made aware of the confidential nature of the Confidential Information, and (iii) are bound by obligations of confidentiality with regard to any Confidential Information received.  Each Party shall remain liable for the uses and disclosures of its Representatives.

 

	
8.1.3  

	
The obligation of confidentiality set out in Section 8.1.2 shall not apply to information that:

 

	 	
(a)  

	
is already in the Receiving Party's or any of its Representatives’ possession at the time of disclosure, as can be demonstrated by the Receiving Party by written records;

 

	 	
(b)  

	
is or later becomes part of the public domain other than as a consequence of a breach of an obligation of confidentiality owed to the Disclosing Party by the Receiving Party;

 

	 	
(c)  

	
is received from a third party having no obligations of confidentiality to the Disclosing Party;

 

	 	
(d)  

	
is independently developed by the Receiving Party or any of its Representatives as can be demonstrated by the Receiving Party by written records; or

 

	 	
(e)  

	
is required by law or regulation to be disclosed by the Receiving Party, provided that as far as legally possible the Receiving Party shall first have given notice to the Disclosing Party and given the Disclosing Party a reasonable opportunity to oppose such disclosure and if disclosed, the Confidential Information disclosed shall be limited to that Confidential Information which is legally required to be disclosed in response to such law or regulation.

 

  

16

  

A combination of features will not be deemed to be within the foregoing exceptions merely because individual features are in the public domain or in the possession of the Receiving Party unless the combination itself is in the public domain or in the possession of the Receiving Party.

 

	
8.1.4  

	
If OXFORD receives a request under the FOI Legislation to disclose any information which, under this Agreement, is TEKMIRA’s Confidential Information, it will notify TEKMIRA and will consult with TEKMIRA. TEKMIRA will respond to OXFORD within seven (7) Business Days after receiving OXFORD’s notice if that notice requests them to provide information to assist OXFORD to determine whether or not an exemption in the FOI Legislation applies to the information requested under the FOI Legislation.

 

	
8.1.5  

	
The Receiving Party may disclose the Disclosing Party’s Confidential Information to the extent such Confidential Information is specifically required to be disclosed to the Ethics Committee or the Regulatory Authority. The Parties acknowledge that there is a general understanding that any such Ethics Committee and Regulatory Authority will keep information submitted to it confidential, and the Receiving Party shall mark any of the Disclosing Party’s Confidential Information disclosed in accordance with this Section 8.1.5 as “confidential”, but each Party accepts that the Receiving Party would be unable to impose any specific obligations upon such bodies.

 

	
8.1.6  

	
The Parties acknowledge and agree that the Protocol shall not be regarded as Confidential Information under this Agreement.

 

	
8.2  

	
Publication

 

Subject to the provisions of Section 8.2.3, the Parties agree as follows:

 

	
8.2.1  

	
TEKMIRA shall not prevent or hinder any registered student of OXFORD from submitting for a degree of OXFORD a thesis based on the Results, the examination of such a thesis by examiners appointed by OXFORD, or the deposit of such a thesis in accordance with the relevant procedures of OXFORD provided that TEKMIRA Confidential Information, TEKMIRA Arising IP and TEKMIRA IP receive the protections afforded under Article 7 (Intellectual Property) and Article 8 (Confidential Information);

 

	
8.2.2  

	
in accordance with normal academic practice, all Personnel shall be permitted to publish the Results following the procedures laid down in Section 8.2.3;

 

	
8.2.3  

	
subject to Section 8.2.7 below, where OXFORD, any registered student of OXFORD or any Personnel wishes, during the Term and for a period of three (3) years after, to submit for publication the Results, OXFORD will submit details of such Results to TEKMIRA in writing not less than ten (10) days in advance of the submission for publication. TEKMIRA may require OXFORD to (a) delay submission for publication if, in TEKMIRA’s reasonable opinion, such delay is necessary in order to seek patent or similar protection for the TEKMIRA Arising IP subsisting in such Results and/or (b) to redact any TEKMIRA Confidential Information or TEKMIRA IP. A delay imposed on submission for publication as a result of a requirement made by TEKMIRA shall not last longer than is absolutely necessary to seek the required protection, and therefore shall not exceed one (1) month from the date of receipt of OXFORD’s notice to publish, although OXFORD will not unreasonably refuse a request from TEKMIRA for additional delay in the event that the property rights of TEKMIRA would otherwise be lost. Notification of the requirement for delay in submission for publication must be received by OXFORD within thirty (30) days after the receipt of the notice to publish by TEKMIRA, failing which OXFORD, its registered students and its Personnel shall be free to assume that TEKMIRA has no objection to the proposed publication.  OXFORD shall provide TEKMIRA a final copy of any pre-publication material to confirm the redaction of TEKMIRA Confidential Information or TEKMIRA IP required by TEKMIRA;

 

  

17

  

	
8.2.4  

	
OXFORD shall register the Clinical Trial on a free-to-user, open access clinical trial databases (e.g. http://www.clinicaltrials.gov.uk) prior to the enrolment of the first Trial Subject. OXFORD shall use its reasonable endeavours to maintain and update the information on such database, as required, during the course of the Clinical Trial;

 

	
8.2.5  

	
the Parties shall comply with recognized standards concerning publication and authorship, including the Uniform Requirements for Manuscripts Submitted to Biomedical Journals issued by the International Committee of Medical Journal Editors;

 

	
8.2.6  

	
in accordance with the Funding terms and conditions, the Parties agree that all publications made of the Results of the Clinical Trial shall include the statement that “This work was supported by the Wellcome Trust and Tekmira Pharmaceuticals Corporation”; and

 

	
8.2.7  

	
OXFORD and TEKMIRA acknowledge and agree that it is necessary for Results and data arising from the Clinical Trial to be made publicly available as soon as reasonably possible in recognition of the international public interest, and immediately provided to the relevant authorities and organizations involved in the implementation of responses to the current outbreak of Ebola Virus Disease, for the purposes of facilitating and informing such responses. OXFORD shall make relevant Results arising from the Clinical Trial (excluding Confidential Information provided by TEKMIRA, unless with TEKMIRA’s express advance consent) available to other research institutions and researchers engaging in research into Ebola Virus Disease as soon as reasonably possible (ideally on a “real time basis”), but always in accordance with the Applicable Requirements. OXFORD and TEKMIRA shall discuss such disclosures in advance and OXFORD shall take TEKMIRA’s reasonable comments into consideration prior to making any such disclosure.

 

	
8.3  

	
No License

 

Except as expressly set forth in this Agreement neither Party will obtain any interest in the other Party’s Confidential Information or Intellectual Property.  OXFORD acknowledges and agrees that it does not acquire a license or any other right and that it shall notify each Consortium Collaborator in writing that they shall not acquire a license or any other right, to TEKMIRA Confidential Information except for the limited purpose of carrying out its rights and obligations under this Agreement and that such limited, non-exclusive, license will expire upon the completion of the Clinical Trial.

 

	
8.4  

	
Return of Confidential Information

 

	
8.4.1  

	
Within thirty (30) days following the completion of the Clinical Trial, OXFORD and each Consortium Collaborator will return to TEKMIRA or destroy and certify destruction in writing, at TEKMIRA’s sole discretion, all Confidential Information of TEKMIRA, including, to the extent practicable, all such information that is electronically stored by OXFORD or any Consortium Collaborator, all reproductions thereof.

 

	
8.4.2  

	
To the extent it is required to do so under applicable laws or in order to ensure compliance with this Agreement, OXFORD and each Representative involved in the conduct of the Clinical Trial may retain one copy of TEKMIRA Confidential Information, provided that such copy is used or accessed solely for the purposes of determining OXFORD and such Representative’s compliance with applicable laws and with this Agreement

 

Article 9 Representations, Warranties  and  Covenants

 

	
9.1  

	
Mutual Representations and Warranties

 

Each Party represents and warrants that

 

  

18

  

	
9.1.1  

	
it has the full power and right to enter into this Agreement and that there are no outstanding agreements, assignments, licenses, encumbrances or rights held by other parties, private or public, inconsistent with the provisions of this Agreement;

 

	
9.1.2  

	
the Person executing this Agreement on its behalf has the full power and authority to enter into this Agreement on its behalf; and

 

	
9.1.3  

	
it shall comply with all applicable laws in the performance of this Agreement.

 

	
9.2  

	
Individual Representations and Warranties

 

	
9.2.1  

	
TEKMIRA represents, warrants, and covenants to OXFORD that all Services shall be performed in compliance with cGMP requirements.

 

	
9.2.2  

	
OXFORD represents, warrants, and covenants to TEKMIRA that OXFORD shall (a) comply with GCP and all local laws and regulations governing the conduct of the Clinical Trial, and (b) notify each Consortium Collaborator that each of them has the obligation to comply with GCP and all local laws and regulations governing the conduct of the Clinical Trial.

 

	
9.3  

	
Disclaimers

 

	
9.3.1  

	
OXFORD makes no representation or warranty that advice or information given by the Chief Investigator or any other Personnel, or the content or use of any Results provided in connection with the Clinical Trial, will not constitute or result in infringement of third-party rights.

 

	
9.3.2  

	
OXFORD accepts no responsibility for any use which may be made of any work carried out under or pursuant to this Agreement, or of the Results, nor for any reliance which may be placed on such work or Results, nor for advice or information given in connection with them.

 

	
9.3.3  

	
TEKMIRA makes no representations or warranties, express or implied, either in fact or by operation of law, by statute or otherwise, and specifically disclaims any and all implied or statutory warranties, including without limitation, any warranty of merchantability or fitness for a particular purpose, efficacy of the Investigational Medicinal Product or Infusion Kits, or warranty of non-infringement.

 

	
9.4  

	
No Implied Warranties

 

EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE 8, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED OR STATUTORY WARRANTIES, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, EFFICACY OF THE DRUG KIT, OR WARRANTY OF NON-INFRINGEMENT.

 

Article 10 LIABILITY

 

	
10.1  

	
OXFORD

 

OXFORD shall, subject to Section 10.2, indemnify TEKMIRA and its Representatives (each, a “TEKMIRA Indemnitee”) against any and all claims, actions or demands, damages, costs and expenses (including any settlements or ex gratia payments made with the consent of OXFORD and any court costs and reasonable legal fees) incurred by TEKMIRA in connection with any claim made or brought (whether successfully or otherwise) by a Trial Subject (or their dependents) that result from any personal injury (including death) to a Trial Subject arising out of or related to the administration of the Investigational Medicinal Product or any clinical intervention or procedure provided for or required by the Protocol to which the Trial Subject would not otherwise have been exposed but for their participation in the Clinical Trial, except to the extent the same is caused by the negligent or wrongful acts or omissions or breach of statutory duty of any TEKMIRA Indemnitee or a breach of their obligations under this Agreement.

 

  

19

  

	
10.2  

	
TEKMIRA

 

TEKMIRA shall, subject to Section 10.1, indemnify OXFORD and its Representatives (each, an “OXFORD Indemnitee”)against any and all claims, actions or demands, damages, costs and expenses (including any settlements or ex gratia payments made with the consent of TEKMIRA and any court costs and reasonable legal fees) incurred by OXFORD, the Trial Sites and the Representatives in connection with any claim made or brought (whether successfully or otherwise) by a Trial Subject (or their dependents) that result from the Investigational Medicinal Product supplied by TEKMIRA and its failure to comply with any requirement of this Agreement, GMP and/or applicable law, except to the extent that the same is caused by the negligence, wrongful acts or omissions or breach of statutory duty of any OXFORD Indemnitee.

 

	
10.3  

	
Conditions

 

	
10.3.1  

	
The indemnities set out in Section 10.1 and Section 10.2 shall not apply to any such claim or proceedings:

 

	 	
(a)  

	
unless as soon as reasonably practicable following receipt of notice of such claim or proceedings, the Indemnified Person shall have notified the indemnifying Party in writing of it and shall, upon the indemnifying Party’s request and at that indemnifying Party’s cost, have permitted the indemnifying Party to have full care and control of the claim or proceedings using legal representation of its own choosing; or

 

	 	
(b)  

	
if the Indemnified Person shall have made any admission in respect of such claim or proceedings or taken any action relating to such claim or proceedings prejudicial to the defence of it without the written consent of the indemnifying Party (such consent not to be unreasonably withheld or delayed), provided that no Indemnified Person shall be deemed to be in breach of this condition by any statement properly made by the Indemnified Person in connection with the operation of the Indemnified Person’s internal complaint procedures, accident reporting procedures, or disciplinary procedures, or where such a statement is required by law.

 

	
10.3.2  

	
The indemnifying Party shall, in relation to any claim or proceedings it has assumed care and control of under Section 10.3.1(a):

 

	 	
(a)  

	
keep the Indemnified Pperson fully informed of the progress of any claim or proceedings;

 

	 	
(b)  

	
consult fully with the Indemnified Person on the nature of any defence to be advanced; and

 

	 	
(c)  

	
not, without the prior written consent of the Indemnified Person (such consent not to be unreasonably withheld or delayed), enter into any settlement or compromise of such claim or proceedings which: (a) would result in injunctive or other relief being imposed against an Indemnified Person; or (b) does not include as an unconditional term the giving by the claimant to all applicable Indemnified Persons of a release from liability in relation to such claim or proceedings.

 

	
10.3.3  

	
Each Party shall use its reasonable endeavours to inform the other Party promptly of any circumstances that are likely to give rise to a claim or proceedings in respect of which it may be entitled to indemnification under Section 10.1 or Section 10.2; and shall keep the other Party reasonably informed of developments in relation to any such claim or proceedings, even where the Party does not intend to make a claim under Section 10.1 or Section 10.2.

 

  

20

  

	
10.3.4  

	
Each Party shall give to the indemnifying Party such assistance as it may reasonably require for the conduct and prompt handling of any such claim or proceedings.

 

	
10.3.5  

	
Nothing in Section 10.1 or Section 10.2 shall restrict or limit an Indemnified Person’s general obligation at law to mitigate a loss it may suffer or incur as a result of an event that gives rise to a claim under Section 10.1 or Section 10.2.

 

	
10.4  

	
LIMITATION OF LIABILITY

 

	
10.4.1  

	
OTHER THAN AS EXPRESSLY SET OUT IN THIS AGREEMENT, AND SUBJECT TO SECTIONS 10.4.3 AND 10.4.4, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY INDIRECT LOSS OR FOR ANY SPECIAL, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES SUFFERED BY THE OTHER PARTY, WHETHER SUCH LOSS ARISES FROM BREACH OF A DUTY IN CONTRACT, TORT, UNDER STATUTE OR IN ANY OTHER WAY INCLUDING, WITHOUT LIMITATION, LOSS ARISING FROM NEGLIGENCE, DEFAULT, BREACH OF DUTY, PRODUCT LIABILITY, STRICT LIABILITY, NON-DELIVERY, DELAY IN DELIVERY OR DEFECTS OR ERRORS IN THE WORK UNDERTAKEN PURSUANT TO THE TERMS OF THIS AGREEMENT, OR IN CONNECTION WITH ANY OTHER CLAIM REGARDLESS OF WHETHER ANY OTHER REMEDY PROVIDED HEREIN FALLS.

 

	
10.4.2  

	
Each Party undertakes to make no claim in connection with this agreement or its subject matter against the other’s employees (apart from claims based on fraud or deliberate default). This undertaking is intended to give protection to individuals: it does not prejudice any right which either Party might have to claim against the other. The benefit conferred by this provision is intended to be enforceable by the persons referred to in it.

 

	
10.4.3  

	
The maximum liability (other than as regards obligations to make payments under Article 4) of each Party to the other Party under or otherwise in connection with this Agreement or its subject matter shall not exceed £2,500,000 together with interest on the balance of such moneys from time to time outstanding, accruing from day to day at the Barclays Bank plc Base Rate from time to time in force and compounded annually as at 31 December. For the avoidance of doubt the indemnities set out in Section 10.1 shall be subject to the cap set out in this Section 10.4.3 of this Agreement.

 

	
10.4.4  

	
Nothing in this Agreement limits or excludes a Party’s liability for: (a) death or personal injury resulting from its negligence; (b) any fraud or fraudulent misrepresentation; or (c) any sort of other liability which, by law, cannot be limited or excluded.

 

Article 11 Term and Termination

 

	
11.1  

	
Term

 

This Agreement will commence as of the Effective Date and shall continue in force until the earlier of (a) termination by either Party as provided herein or (b) completion of the Clinical Trial (the “Term”).

 

	
11.2  

	
Cancellation or Termination by OXFORD

 

	
11.2.1  

	
OXFORD acknowledges that TEKMIRA must commit considerable resources in advance of Manufacturing the Investigational Medicinal Product and supplying the Infusion Kits by purchasing raw materials and components, and allocating lab space, time, equipment and human resources. Accordingly, if OXFORD cancels delivery of Investigational Medicinal Product and/or Infusion Kits, or terminates this Agreement for reasons other than TEKMIRA’s material breach of this Agreement, TEKMIRA shall have the right to retain all Investigational Medicinal Product and Infusion Kits under production and not yet shipped. For clarity, this right of TEKMIRA to retain or to have Investigational Medicinal Product returned for its exclusive use, is in addition to and not in substitution of TEKMIRA’s right to retain the Deposit, and any such use by TEKMIRA shall be subject to prior discussion with OXFORD and the Wellcome Trust (with Wellcome Trust approval being necessary prior to TEKMIRA’s use of the returned or retained Investigational Medicinal Product).

 

  

21

  

	
11.2.2  

	
OXFORD shall have the right to reject any shipment of the Investigational Medicinal Product or Infusion Kits that does not conform with the requirements of this Agreement in all material respects. OXFORD shall not be required to pay any invoice with respect to any shipment of the Investigational Medicinal Product or the Infusion Kits properly rejected pursuant to this Section 11.2.2. At OXFORD's option, OXFORD shall be entitled either:

 

	 	
(a)  

	
to a refund of all Service Fees paid by the University with respect to such rejected shipment (including the Deposit); or

 

	 	
(b)  

	
to require TEKMIRA to replace such rejected shipment at no additional cost to OXFORD.

 

	
11.2.3  

	
In the event that OXFORD selects the option under Section 11.2.2(b) with respect to any shipment of the Investigational Medicinal Product or the Infusion Kits:

 

	 	
(a)  

	
TEKMIRA shall replace the rejected shipment as soon as reasonably practicable after the rejection; and

 

	 	
(b)  

	
TEKMIRA shall provide OXFORD with updated delivery information (including estimated delivery dates of replacement product) upon it becoming available.

 

	
11.3  

	
Termination for Cause

 

	
11.3.1  

	
Either Party may terminate this Agreement:

 

	 	
(a)  

	
for the other Party’s material or persistent breach of this Agreement. Prior to any such termination the Party seeking to terminate shall give the other Party thirty (30) days prior written notice of its intention to so terminate, which notice will set forth the default(s) which form the basis for such termination. If the defaulting Party fails to correct such default(s) within the thirty (30) day notice period, this Agreement shall automatically terminate;

 

	 	
(b)  

	
with immediate effect on giving written notice to the other Party, if the other Party becomes insolvent, or if an order is made or a resolution is passed for its winding up (except for the purpose of solvent amalgamation or reconstruction), or if an administrator, administrative receiver or receiver is appointed over the whole or any part of the other Party’s assets, or if the other Party makes an arrangement with its creditors.

 

	
11.3.2  

	
If the application of the Chief Investigator or, as the case may be, OXFORD in relation to the Ethics Committee Opinion and/or the Regulatory Authority is finally rejected, and there is no possibility of appeal against such rejection, either Party may terminate this Agreement with immediate effect by giving written notice to the other Party.

 

	
11.3.3  

	
If, at any time during the Term, the Ethics Committee Opinion and/or the Regulatory Approval is suspended, revoked or otherwise terminated, and there is no possibility of appeal against such suspension, revocation or termination, either Party may terminate this Agreement with immediate effect by giving written notice to the other Party.

 

  

22

  

	
11.3.4  

	
This Agreement may be terminated by either Party with immediate effect by giving written notice to the other Party if it has reasonable and substantial grounds for believing the Clinical Trial should cease in the interests of the health and safety of the Trial Subjects or Representatives working in such Clinical Trial.

 

	
11.3.5  

	
The provisions of this Section 11.3 are without prejudice to Section 5.1.3 or any other rights a Party may have to terminate this Agreement.

 

	
11.3.6  

	
[***].

 

	
11.4  

	
Other Remedies

 

Section 11.3 will not be exclusive and will not be in lieu of any other remedies available to a Party hereto for any default hereunder on the part of the other Party.

 

	
11.5  

	
Continuing Obligations

 

Termination of this Agreement for any reason will not relieve the Parties of any obligation accruing prior thereto and any obligations hereunder and will be without prejudice to the rights and remedies of either Party with respect to any antecedent breach of the provisions of this Agreement.

 

	
11.6  

	
Alternate Remedies

 

Nothing in this Agreement shall be deemed as preventing either Party from seeking specific performance, injunctive or other equitable relief or any other provisional remedy from any court having jurisdiction over the Parties and the subject matter of the Dispute as necessary to protect the name, Confidential Information or Intellectual Property belonging to either Party or their respective Representatives without proof of actual damages and without the posting of bond or security for costs.

 

Article 12 General Provisions

 

	
12.1  

	
Publicity and Advertising

 

Neither Party will use the other Party’s name or the name of any member of that Party’s personnel in any advertising, packaging, promotional material, or any other publicity without the prior written approval of the other Party.

 

	
12.2  

	
Amendment

 

This Agreement may be amended or modified only in writing signed by the Parties.

 

	
12.3  

	
Assignment and Subcontracting

 

The rights and obligations covered hereunder are personal to each Party hereto and for this reason this Agreement will not be assignable by either Party in whole or in part, without the prior written consent of the other Party in each instance; provided, however, that the restriction contained herein will in no way limit the rights of TEKMIRA to assign or appoint as its agent for any purpose of this Agreement any Affiliates or assign such rights to any Person or entity that purchases or licenses all or substantially all of the assets of TEKMIRA or its Affiliate or acquires or is combined with TEKMIRA in a merger or some other form of business combination. This Agreement will be binding upon and will enure to the benefit of the Parties hereto and to any permitted assignee or successor of either Party. Subject to other provisions of this Section 12.3, if one Party validly assigns any or all of its obligations hereunder, such assigning Party agrees to remain bound by all of its responsibilities and obligations hereunder. Any and all assignments of this Agreement or any interest herein not made in accordance with this Section 12.3 will be void ab initio.

 

  

23

  

	
12.4  

	
Counterparts

 

This Agreement may be executed in counterparts with the same effect as if both Parties had signed the same document. Both counterparts shall be construed together and shall constitute one and the same agreement. This Agreement may be executed by the Parties and transmitted by facsimile transmission or PDF copy, and if so executed and transmitted this Agreement shall be for all purposes as effective as if the Parties had delivered an executed original Agreement.

 

	
12.5  

	
Entire Agreement and Exhibits

 

This Agreement constitutes the entire agreement of the Parties, superseding any and all previous agreements, whether oral or written, as to any purchase of Investigational Medicinal Products or Services.  Each Exhibit is incorporated by reference and made a part of this Agreement.

 

	
12.6  

	
Force Majeure

 

If either Party is prevented from complying, either totally or in part, with any of the terms or provisions set forth herein by reason by circumstances beyond its reasonable control (“force majeure”), including, by way of example and not of limitation, fire, flood, explosion, storm, riot, war, rebellion, accidents, acts of God, acts of governmental agencies or instrumentalities, inability to acquire sufficient raw materials, failure of suppliers or any other cause or externally induced casualty beyond its reasonable control, whether similar to the foregoing contingencies or not, said Party will provide written notice of same to the other Party. Said notice will be provided within seven (7) days of the occurrence of such event and will identify the requirements of this Agreement or such of its obligations as may be affected, and to the extent so affected, said obligations will be suspended during the period of such disability. The Party prevented from performing hereunder will use commercially reasonable efforts to remove such disability and will continue performance of the affected obligations whenever such causes are removed provided that the Party will throughout the period of disability continue performance of the non-affected obligations. The Party so affected will give to the other Party a good faith estimate of the continuing effect of the force majeure condition and the duration of the affected Party’s non-performance. If the period of delay or non-performance continues for thirty (30) days, the Party not affected may terminate this Agreement by giving fourteen (14) days’ written notice to the affected Party.

 

	
12.7  

	
Further Acts

 

Both Parties hereby undertake to do such further acts and take such steps as may be reasonably required to implement the intent of this Agreement.

 

	
12.8  

	
Governing Law

 

This Agreement will be governed and construed in accordance with the laws of England and Wales, excluding any choice of law rules that may direct the application of the law of another jurisdiction.

 

	
12.9  

	
Sale of Goods

 

The application of the 1980 United Nations Convention on Contracts for the International Sale of Goods is expressly excluded with respect to this Agreement.

 

	
12.10  

	
Notice

 

Notices provided under this Agreement to be given or served by either Party on the other will be given in writing and served personally, by prepaid registered mail, return receipt requested, by a reputable courier company or by means of facsimile to the following respective addresses or to such other addresses as the Parties may hereafter advise each other in writing. Each such notice shall be deemed delivered (i) on the date delivered if by personal delivery, (ii) on the date telecommunicated if by facsimile, and (iii) on the date upon which the return receipt is signed or delivery is refused, as the case may be, if mailed.

 

  

24

  

To OXFORD:

University of Oxford                                                 Tel:  +44 (0) 1865 572201

NDM Research Building                                          Fax: +44 (0) 1865 572215

Old Road Campus, Roosevelt Dr.                           Attention: Principal Investigator and

Oxford, 0X3 7FZ                                                        Department Administrator

United Kingdom

And

University of Oxford                                                 Tel: 01865 270138

Legal Services Office                                                Fax: 01865 280569

Wellington Square,                                                   Attention: Director of Research Services

Oxford OX1 2JD

United Kingdom

 

To TEKMIRA:

Tekmira Pharmaceuticals Corporation                   Tel:  +1 (604) 419-3205

100-8900 Glenlyon Parkway                                     Fax: +1 (604) 419-3201

Burnaby, B.C. V5J 5J8                                               Attention:  Sr. VP Business Development

Canada

 

	
12.11  

	
Severability

 

If any provision of this Agreement is held to be illegal, invalid or unenforceable under present or future laws effective while this Agreement remains in effect, the legality, validity and enforceability of the remaining provisions will not be affected thereby.

 

	
12.12  

	
Waiver

 

No delay or waiver on the part of TEKMIRA or OXFORD in exercising any right, power or privilege hereunder will operate as a waiver of either TEKMIRA or OXFORD of any right, power or privilege hereunder nor will any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder.

 

	
12.13  

	
Survivorship

 

Expiration or termination of this Agreement for any reason will not relieve either party of any obligation accruing prior to such expiration or termination or of any rights and obligations of the parties that by their terms survive termination or expiration of this Agreement, including the provisions of Article 1, Sections 3.1, 3.4.2, 4.1.2, 4.1.6,  5.4, 5.5,  Sections 6.6, 6.7, 6.8, Article 7 , Article 8, Sections 9.3 and 9.4, Article 10, Article 11, and Article 12 of this Agreement.

 

  

25

  

IN WITNESS WHEREOF, duly authorized Representatives of the Parties have executed this Agreement on the date first above written.

 

The Chancellor Masters and Scholars of the University of Oxford

 

By:__________________________________                                           By:__________________________________

(signature)                                                                                                            (signature)

 

Name:________________________________                                           By:__________________________________

(print name)                                                                                                          (print name)

 

Title:_________________________________                                           Title:_________________________________

 

 

Acknowledged by Chief Investigator

By:_________________________________

(signature)

Name:______________________________

(print name)

 

 

Tekmira Pharmaceuticals

Corporation

(on behalf of itself and its Affiliate,

Protiva Biotherapeutics, Inc.)

By:__________________________________                                           By:__________________________________

(signature)                                                                                                         (signature)

 

Name:________________________________                                           Name:________________________________

(print name)                                                                                                      (print name)

 

Title:_________________________________                                           Title:_________________________________

 

  

26

  

EXHIBIT 1.1.34 CONTENT OF INFUSION KIT

One Infusion Kit, intended for single use only, is required for each administration of TKM-Ebola, and contains filters, needles, syringes, IV bags, and shipping bins.

  

27

  

EXHIBIT 1.1.38INVESTIGATIONAL MEDICINAL PRODUCT DESCRIPTION

 

TKM-130803 Product Description

 

[***]

  

28

  

EXHIBIT 3.3.1 DELIVERY

 

	
·

	
Shipment of Investigational Medicinal Product and Infusion Kits will be made in two (2) lots;

 

	
·

	
Shipments will only be made following TEKMIRA’s receipt of OXFORD’s written shipping details as follows:

	
  

	
(a)

	
the relevant VAT number of the recipient for customs purposes;

	
  

	
(b)

	
full details of the shipment destination address; and

	
  

	
(c)

	
the personal name and mobile phone number of the individual authorized to receive such shipments;

	
  

	
(together, the “Shipping Details”).

 

	
·

	
Subject to TEKMIRA having received OXFORD’s Shipping Details on or before December 10, 2014, the first lot will be shipped on December 15, 2014 and the second lot will be shipped on January 3, 2015.

 

	
·

	
If TEKMIRA receives OXFORD’s Shipping Details after December 10, 2014, TEKMIRA will ship the first lot within ten (10) Business Days, and the second lot within fifteen (15) Business Days, following receipt of OXFORD’s Shipping Details.  Notwithstanding anything to the contrary in the foregoing, for security of shipment receipt and handling, no lots will be shipped between the dates of December 16, 2014 and January 2, 2015 inclusive.

 

	
·

	
TEKMIRA shall not be liable for any delays arising from national or international government, customs or courier interactions.

 

  

29

  

EXHIBIT 5.3.1 STABILITY STUDY PARAMETERS

Three lots will be set aside for stability testing as follows:

	
·

	
[***]

 

	
·

	
[***]

 

	
·

	
[***]

 

 

 

30Exhibit 10.1

 

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

 

 

 

 

 

(1) IMMUNOCORE LIMITED

 

and

 

(2)  ADAPTIMMUNE LIMITED

 

 

 

 

 

 

 

 

 

 

ASSIGNMENT AND EXCLUSIVE LICENCE

 

 

 

 

 

 

 

 

 

 

Manches LLP

9400 Garsington Road

Oxford Business Park

Oxford

OX4 2HN

 

Tel: 01865 722106

Fax: 01865 201012

www.manches.com

 

 

Page 2

 

 

THIS AGREEMENT is made BETWEEN:

 

(1)                                 IMMUNOCORE LIMITED (company number 6456207) whose registered office address is AT 57c Milton Park, Abingdon, Oxfordshire, OX14 4RX (the “Immunocore”); and

 

(2)                                 ADAPTIMMUNE LIMITED (company number 6456741) whose registered office address is 9400 Garsington Road, Oxford Business Park, Oxford, OX4 2HN (the “Adaptimmune”).

 

BACKGROUND

 

A.                                   Immunocore is a company engaged in identifying modifying, developing and commercialising products containing soluble T-Cell Receptors for use in certain applications.

 

B.            Adaptimmune is a company engaged in identifying, modifying, developing and commercialising products containing cells that are transfected within genes encoding T-Cell Receptors for use in certain applications.

 

C.                                   The Parties previously entered into an Amended and Restated Licence Agreement (“2011 Agreement”), which amended and restated the terms of an original licence agreement dated 1 July 2008 between Medigene Limited and Adaptimmune (“2008 Agreement”). This 2008 Agreement was novated to Immunocore on 1 October 2008.

 

D.                                   The Parties now wish to rationalise the ownership of Intellectual Property Rights under the Prior Agreements and the licensing of such Intellectual Property Rights between the Parties.

 

OPERATIVE PROVISIONS

 

1.                                     Definitions and Interpretation

 

1.1.                          In this Agreement the following words and phrases have the meaning set out below:

 

	
“Adaptimmune Licensed Product”
    	
 
    	
means (i) any   product that contains cells that are transfected with genes encoding TCRs   including any product containing cells that may also be transfected with one   or more additional other molecules as well (whether transfected at the same   time or by the same means as the TCRs or not); and (ii) any process,   service or method including such a product and where:

 

 (a)         such product is covered by any   claim of the Licensed Patents or which is generated or derived using any of   the Know-How or Results; or

 

(b)          such   service, process or method is covered by a claim of any of the Licensed   Patents or which requires the use of any Know-How or Results;

 

For the avoidance of   doubt Adaptimmune Licensed Product shall not include any product, service,
    

 

 

Page 3

 

 

	
 
    	
 
    	
process or method   comprising or containing Soluble TCRs.
    
	
 
    	
 
    	
 
    
	
“Affiliate”
    	
 
    	
means, in relation to any entity, any company or legal entity in any   country which Controls, is Controlled by or shares common Control with that   entity. The Parties shall not be Affiliates for the purposes of this   Agreement;
    
	
 
    	
 
    	
 
    
	
“Authorised Parties”
    	
 
    	
means Affiliates, contractors,   employees, licensees (and prospective licensees), sub-licensees (and   prospective sub-licensees) and potential acquirers;
    
	
 
    	
 
    	
 
    
	
“Confidential Information”
    	
 
    	
means (a) in relation to each   PParty, all technical, financial and commercial information disclosed by that   Party to the other Party in the course of or in anticipation of this   Agreement, together with the terms of this Agreement; (b) all Know-How;   (c) all Results.
    
	
 
    	
 
    	
 
    
	
“Control”
    	
 
    	
means:

 

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

 

(b)          the   ability to direct the casting of more than 50% of the votes, exercisable at a   general meeting of the relevant entity on all, or substantially all, matters;
    
	
 
    	
 
    	
 
    
	
“Core Patent”
    	
 
    	
means a patent or   patent application designated as “Core” in Schedule 1;
    
	
 
    	
 
    	
 
    
	
“Divisional”
    	
 
    	
means any divisional   patent application or continuation-in-part application claiming any of the   same priority as a Full Application, Later Application, Granted Patent or   Core Patent.
    
	
 
    	
 
    	
 
    
	
“Effective Date”
    	
 
    	
means the date of last   signature to this Agreement;
    
	
 
    	
 
    	
 
    
	
“Full Application”
    	
 
    	
shall have the meaning   given in Schedule 3;
    
	
 
    	
 
    	
 
    
	
“Granted Patent”
    	
 
    	
means a patent or   patent application designated as “Granted” in Schedule 1;
    
	
 
    	
 
    	
 
    
	
“Immunocore Licensed Product”
    	
 
    	
means (i) any   product that contains Soluble TCRs; and (ii) any process, service or   method including such a product and where:

 

 (a)                   such   product is covered by any claim of the Licensed Patents or which is generated   or derived using any of the Know-How or Results; or

 

(b)          such   service, process or method is covered by a claim of any of the Licensed   Patents or which requires the use of any Know-How or Results;

 

For the avoidance of   doubt Immunocore Licensed
    

 

 

Page 4

 

 

	
 
    	
 
    	
Product shall not   include any product, service process or method containing or comprising cells   that are transfected with genes encoding TCRs.
    
	
 
    	
 
    	
 
    
	
“Intellectual Property Rights”
    	
 
    	
means patents, rights   to inventions, copyright and related rights, trade marks, trade names and   domain names, rights in designs, rights in computer software, database   rights, rights in confidential information (including know-how as summarised   in schedule 2) and any other intellectual property rights, in each case whether   registered or unregistered and including all applications (or rights to   apply) for, and renewals or extensions of, such rights and all similar or   equivalent rights or forms of protection which subsist or will subsist now or   in the future in any part of the world;
    
	
 
    	
 
    	
 
    
	
“Know-How”
    	
 
    	
means all confidential   information (excluding the Licensed Patents) created by either Party and   relating to t-cell receptors, modifications to t-cell receptors, processes   for the production of products comprising t-cell receptors, products   comprising t-cell receptors, whether patentable or not as at the Effective   Date. Know-How shall include all know-how summarised in Schedule 2;
    
	
 
    	
 
    	
 
    
	
Later Application
    	
 
    	
shall have the meaning   given in Schedule 3;
    
	
 
    	
 
    	
 
    
	
“Licensed Patents”
    	
 
    	
means:

 

(a)           the   patents or patent applications listed in Schedule 1;

 

(b)           any   patents granted from the patent applications listed in Schedule 1;

 

(c)           any   patents or patent applications filed in accordance with Clause 4.3 and any   patents granting from such patent applications;

 

(d)          any   corresponding patents and patent applications which are based on or derive   priority from or common priority with the patent applications in (a) or   (b) or (c); and

 

(d)          any   continuation, continuation-in-part, division, reissue, renewal or extension   of any of the patents and patent applications in (a) – (d).
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
“Licensed Product”
    	
 
    	
means an Adaptimmune   Licensed Product and/or an Immunocore Licensed Product.
    

 

 

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“Market”
    	
 
    	
means, in relation to a   Licensed Product, offering to sell, lease, license or otherwise commercially   exploit the Licensed Product or the sale, lease, licence, export or import,   distribution, marketing or other commercial exploitation of the Licensed   Product;
    
	
 
    	
 
    	
 
    
	
Materials
    	
 
    	
means the materials   provided by one Party to the other Party for the performance of the Project   including all constructs, libraries, derivatives, portions, improvements or   components of them or obtained from them or as a result of their use but   excluding Results;
    
	
 
    	
 
    	
 
    
	
“NCI Patent”
    	
 
    	
means (i) patent   application PCT/US2007/79487; and (ii) any corresponding patents and   patent applications which are based on or derive priority from or common   priority with PCT/US2007/79487; and (iii) any continuation,   continuation-in-part, division, reissue, renewal or extension of any of the   patents and patent applications in (i) and (ii).
    
	
 
    	
 
    	
 
    
	
“Prior Agreements”
    	
 
    	
means the 2011   Agreement and the 2008 Agreement.
    
	
 
    	
 
    	
 
    
	
“Project”
    	
 
    	
means any project   agreed between the Parties in relation to the development, modification,   creation, adaptation, mutation or other work in relation to any TCR and as   set out in a Project Schedule signed by both Parties.
    
	
 
    	
 
    	
 
    
	
“Project Schedule”
    	
 
    	
Shall have the meaning   set out in Clause 6.1.
    
	
 
    	
 
    	
 
    
	
“Required Countries”
    	
 
    	
means European Union,   United States of America and Canada.
    
	
 
    	
 
    	
 
    
	
“Results”
    	
 
    	
means all Intellectual   Property Rights (excluding Licensed Patents and any Divisional filed in   accordance with Clauses 4.4 and 4.5) generated or created by either Party in   the performance of any Project.
    
	
 
    	
 
    	
 
    
	
“Soluble TCRs”
    	
 
    	
TCRs in any form   (whether alone or combined with other compounds or molecules) and which when   administered or supplied are not comprised within or attached to (including   via transfection) any cell.
    
	
 
    	
 
    	
 
    
	
“SUSAR”
    	
 
    	
means a suspected, unexpected,   serious adverse reaction, in relation to which notification to a competent   authority is required..
    
	
 
    	
 
    	
 
    
	
“TCR”
    	
 
    	
means T-cell receptor
    
	
 
    	
 
    	
 
    
	
“Territory”
    	
 
    	
means worldwide.
    

 

 

Page 6

 

 

1.2.                            In this Agreement:

 

1.2.1.               references to Clauses are to the Clauses of this Agreement;

 

1.2.2.               references to the Parties are to the Parties to this Agreement;

 

1.2.3.               headings are used for convenience only and do not affect its interpretation; and

 

1.2.4.               references to a statutory provision include references to the statutory provision as modified or re-enacted or both from time to time and to any subordinate legislation made under the statutory provision.

 

2.                                     Assignment

 

2.1.                          Nothing in this Agreement will assign or transfer any Intellectual Property Rights between the Parties unless explicitly otherwise provided.

 

2.2.                          Adaptimmune hereby assigns and agrees to assign all its right, title and interest in the Know-How, Results and Licensed Patents to Immunocore.

 

2.3.                          In consideration of the assignment under Clause 2.2 above, Immunocore hereby assigns and agrees to assign a one half undivided interest in all its right, title and interest in the Know-How, Results and Licensed Patents to Adaptimmune.  Following such assignment the Parties shall own such Know-How, Results and Licensed Patents jointly in equal undivided shares.

 

2.4.         Each Party agrees to execute or procure the execution of any further document or confirmatory assignment which may be reasonably required to effect ownership in accordance with Clauses 2.2 and 2.3 above.

 

2.5.                          Save for the Results, any improvements or new Intellectual Property Rights created after the Effective Date shall, unless otherwise agreed in writing at any time by both Parties, be owned by the Party or Parties creating such rights.

 

2.6.                          Either Party may on provision of reasonable notice, have access to and make copies of any documentation, files, programs or other materials which embody or set out any of the Know-How or Results to support any regulatory filing, provided such Party reimburses any reasonable costs incurred.

 

2.7.                          Where either Party identifies a SUSAR as part of any clinical trial on any TCR which is the subject of the Licensed Patents or a Project , it shall provide details of the SUSAR to the other Party including where necessary any documentation or underlying materials relevant to the SUSAR in sufficient detail for the other Party to determine any regulatory notification requirements and safety implications in relation to its own products.

 

3.                                     Grant of Licence

 

3.1.                          Immunocore grants to Adaptimmune and Adaptimmune accepts an exclusive, royalty free, irrevocable licence under Immunocore’s rights in the Licensed Patents, the Know-How and the Results to develop, make, have made, use and have used and Market Adaptimmune Licensed Products in the Territory.

 

3.2.                          Adaptimmune grants to Immunocore and Immunocore accepts an exclusive, royalty free, irrevocable licence under Adaptimmune’s rights in the Licensed

 

 

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Patents, the Know-How and the Results to develop, make, have made, use and have used and Market Immunocore Licensed Products in the Territory.

 

3.3.                          The licences set out in Clauses 3.1 and 3.2 shall include the right to use the Licensed Patents, Results and Know-How for the purposes of clinical research and development including the performance of clinical trials in relation to Licensed Products.

 

3.4.                          All implied licences and rights are excluded to the full extent permitted by law.

 

3.5.                          Adaptimmune and Immunocore may sub-license the rights granted to them in Clauses 3.1, 3.2 and 3.3, subject to Clause 3.6 provided that each will ensure that any sub-licensee agrees to treat the Confidential Information in accordance with confidentiality terms at least as strict as those set out in this Agreement. There is no requirement to seek consent from the other Party in relation to the grant of any sub-licence, consent is deemed given. Each Party is responsible for the performance of any sub-licence by its sub-licensees.

 

3.6.                          For the avoidance of doubt and save as explicitly provided in this Agreement, both Parties are free to further develop their rights in the Licensed Patents, Know-How and Results independently of the other Party. Where any further development or research by Adaptimmune (including any development resulting in a new TCR) uses any part of the Licensed Patents, Know-How and Results, Adaptimmune understands and agrees that it has no right to commercialise or exploit or otherwise supply any Immunocore Licensed Product and it is given no licence by Immunocore under Immunocore’s rights in the Licensed Patents, Know-How and Results in relation to any Immunocore Licensed Product. Where any further development or research by Immunocore (including any development resulting in a new TCR) uses any part of the Licensed Patents, Know-How and Results, Immunocore understands and agrees that it has no right to commercialise or exploit or otherwise supply any Adaptimmune Licensed Product and it is given no licence by Adaptimmune under Adaptimmune’s rights in the Licensed Patents, Know-How and Results in relation to any Adaptimmune Licensed Product.

 

3.7.                          The licences set out in Clauses 3.1-3.3 are subject to the following:

 

3.7.1.               the rights of the National Cancer Institute as a joint owner of the NCI Patents to use the NCI Patents and to grant non-exclusive licences under the NCI Patents;

 

3.7.2.     the exclusive rights of Sanofi Pasteur Limited to certain soluble TCR reagents under a collaborative research and exclusive licence agreement dated 1 December 2006 (as amended and novated).

 

4.                                     Obligations and Prosecution of Intellectual Property Rights

 

4.1.                          Any Licensed Patents including those which have been filed prior to the Effective Date shall be prosecuted, maintained and enforced in accordance with Schedule 3 to this Agreement. Where Licensed Patents have been filed prior to the Effective Date, such Licensed Patents shall be designated as either Provisional Applications, Full Applications, Later Applications, Granted Patents, Lapsed Patents or Core Patents in accordance with Schedule 1; and Schedule 3 shall apply to such Licensed Patents in accordance with their designation.

 

4.2.                          Should either Party wish to file any patent or patent application (other than any Divisional filed in accordance with Clauses 4.4 and 4.5 below) which is based on

 

 

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the Know-How or Results or covering or including any of the same subject matter as in a previously filed Licensed Patent, it shall notify the other Party (“Notification”). Such patent or patent application shall be filed, prosecuted, maintained and enforced in accordance with Schedule 3.

 

4.3.                          Should either Party (“Filing Party”) wish to file any Divisional which is specific to in the case of Adaptimmune, the Adaptimmune Licensed Products, and in the case of Immunocore, the Immunocore Licensed Products it may notify the other Party (“Recipient Party”) in writing. Such notification shall include sufficient detail to enable the Recipient Party to determine whether the Divisional does or does not relate solely to the Filing Party’s Licensed Products. Where it agrees that the Divisional does relate solely to the Filing Party’s Licensed Products, it shall notify the Filing Party in writing within a period of thirty (30) days from receipt of notice from the Filing Party. Following receipt of such notification, Filing Party shall be entitled to file the Divisional and to control the filing, prosecution and maintenance of such Divisional in its sole discretion. Unless otherwise agreed in writing by both Parties, the Divisional shall be filed in the joint names of Immunocore and Adaptimmune.

 

4.4.                          Where the Recipient Party under Clause 4.3 either (a) does not respond to the notification from the Filing Party within a period of thirty (30) days from receipt of notice; or (b) notifies Filing Party that Divisional does not solely relate to Filing Party’s Licensed Products or that it has not received sufficient information to enable a determination of whether the Divisional does relate solely to Filing Party’s Licensed Products then on expiry of a period of 30 days from receipt of notice by Recipient Party either Party may refer any outstanding issues to an independent expert (“Expert” for the purposes of this Clause) by the service of written notice on the other Party (“Dispute Notice” for the purposes of this Clause).  During the referral to an Expert, Filing Party shall not be entitled to file the Divisional until the Expert has provided his decision. The Parties shall use reasonable endeavours to agree the Expert within 14 days of date of Dispute Notice, failing which the Expert shall be appointed by the President of the Law Society of England and Wales as soon as reasonably possible. Following appointment of Expert, both Parties shall simultaneously serve written arguments in relation to the dispute on both the Expert and the other Party within fourteen (14) days of appointment of Expert. Within a further period of 14 days from date of service of written arguments, each Party may serve a further written reply on both the Expert and other Party. The Expert will make his decision based on the exchanged written statements and shall issue his decision in writing to both Parties within a period of fourteen (14) days of service of last reply from a Party. The decision of the Expert shall be final and binding on the Parties, save for any manifest errors contained on the face of his decision. Unless otherwise provided by the Expert, the Expert’s charges shall be borne equally by the Parties. Where Expert finds in favour of the Filing Party then following issue of decision, Filing Party shall be entitled to file the Divisional and to control the filing, prosecution and maintenance of such Divisional in its sole discretion. Where Expert finds in favour of the Recipient Party, then Filing Party shall not file the Divisional.

 

4.5.                          For the avoidance of doubt where a Divisional is agreed to relate solely to the Filing Party’s Licensed Products under Clause 4.3 or is found by an Expert to relate solely to the Filing Party’s Licensed Products under Clause 4.4, the Recipient Party shall have no licence under such Divisional or right to sub-licence such Divisional to the extent such Divisional continues to relate solely to the Filing Party’s Licensed Products.

 

5.                                     Financial Provisions

 

 

Page 9

 

5.1.                          Payments under this Agreement shall be made in pounds sterling by bank telegraphic transfer to the credit of a bank account nominated by Immunocore or Adaptimmune as relevant.   All payments shall be due within forty-five (45) days of receipt of invoice. Where any amount in an invoice is disputed, paying Party shall pay any un-disputed amount whilst the dispute as to remaining amounts is resolved.

 

5.2.                          All payments under this Agreement shall be made without deduction of income tax or other taxes, charges or duties that may be imposed, except and so far as Adaptimmune or Immunocore is required to make those deductions to comply with applicable laws.

 

5.3.                          If full payment of any amount due is not made by the due date, the invoicing Party may charge interest on the outstanding amount on a daily basis at a rate equivalent to two percent (2%) above the base rate for the time being of HSBC Bank Plc from the date when payment was due until the date of actual payment.

 

6.                                     Projects

 

6.1.                          The Parties may agree to collaborate on Projects at any time after the Effective Date. The Parties shall agree the scope of each Project in writing and in the form of a Project Schedule, a template for which is set out in Schedule 4A. The Parties shall also specify the details of the TCR or TCRs being developed in such Project Schedule.  The Project Schedule shall become effective and shall become part of this Agreement as of the date of signature of both Parties to the relevant Project Schedule. Schedule 4B lists projects agreed between the Parties as at the Effective Date and such projects shall be deemed Projects under this Agreement as from the Effective Date.

 

6.2.                          Each Party shall use reasonable skill and care to perform the Project and will use reasonable endeavours to perform its tasks under any Project within the timescales agreed between the Parties, as specified in the Project Schedule.

 

6.3.                          Each Party will use reasonable endeavours to ensure that all employees contributing to any Project keep detailed notebooks and comply with any laboratory record keeping protocol agreed between the Parties. Any work relating to the performance of the Project shall be recorded in a Project specific notebook.

 

6.4.                          Each Party will in the Project Schedule assign a project manager to each Project to manage the day to day performance of the Project.  Each Party shall have the right to change its project manager upon written notice to the other Party in accordance with 11.9.

 

6.5.                          Both Parties shall have access in accordance with the terms of this agreement to any results, data, raw materials, materials or output generated or created from the performance of any Project.

 

6.6.                          Any Materials shall remain the property of the providing Party unless otherwise agreed in writing between the Parties. The other Party shall have access to any such Materials on reasonable notice and to the extent necessary for full use of the Results, Know-How or Licensed Patents. The Party owning the Materials shall use reasonable endeavours to:

 

6.6.1.                         keep the Materials secure;

 

 

Page 10

 

6.6.2.                         use the Materials in accordance with good laboratory practice and with reasonable skill and care; and

 

6.6.3.                       ensure compliance with all applicable laws and regulations governing the transportation, keeping and use of the Materials.

 

6.7.       The obligations under Clause 6.5 shall apply for a period of ten (10) years following completion of relevant Project or termination of this Agreement (where termination occurs prior to completion of any relevant Project). Completion of such Project shall mean the shorter of (a) when all deliverables agreed to be required under such Project have been delivered in accordance with the Project; or (b) the end date specified in the Project Schedule as amended from time to time by the Parties.

 

6.8.       Both Parties will ensure that all individuals working on or performing the Project are under contracts of employment which (to the extent legally possible) assign to such Party all right, title and interest in any Results. Each Party shall procure the execution and delivery of such further documentation (including confirmatory assignments) as may be required during the filing, prosecution and maintenance of any patents or patent applications in accordance with Schedule 3.

 

6.9.       To the extent not licensed under Clauses 3.1, 3.2 and 3.3 above and subject to any third Party restrictions or terms, each Party grants to the other Party a royalty-free, non-exclusive licence to use its rights in any Intellectual Property Rights for (a) the purposes of performing the Project; and (b) to the extent strictly necessary for use of the Results to develop, make, have made, use and have used and Market in the case of Adaptimmune, the Adaptimmune Licensed Products and in the case of Immunocore, the Immunocore Licensed Products.

 

6.10.                   Prior to the start of any Project, if either Party is aware of any third Party restrictions or terms which would impact on its ability to grant the licence under Clauses 3.1, 3.2, 3.3 and 6.8 or otherwise impact on the performance of the Project it shall notify those in writing to the other Party. Where any third Party restrictions or terms are notified, the Party receiving such notification shall be deemed to have agreed to such restrictions or terms, or to perform the Project subject to such third Party terms or restrictions unless it notifies the other Party in writing stating it cannot accept such terms or restrictions and no longer wishes to perform the Project.

 

6.11.                   During any Project neither Party will conduct any other project, development or research using the same TCR as specified for use in the Project with any third Party without the prior written agreement of the other Party.

 

6.12.                   A Party may serve thirty (30) days written notice on the other Party (“Defaulting Party”) terminating any particular Project where the Defaulting Party is in material breach of its obligations under Clause 6.2 above. Where the Defaulting Party has not corrected the breach within the thirty (30) day notice period and subject to Clause 6.13 below, the Project shall terminate. Where the Defaulting Party is Immunocore, termination of the Project shall result in the Results which relate solely to that Project being removed from the licence under Clause 3.2 and Immunocore shall cease to be licensed under such Results from the date of termination. Any further use of such Results by Immunocore shall require the prior written consent of Adaptimmune.  Where the Defaulting Party is Adaptimmune, termination of the Project shall result in the Results which relate solely to that Project being removed from the licence under Clause 3.1 and Adaptimmune shall cease to be licensed under such Results from the date of termination. Any further use of such Results by Adaptimmune shall require the 

 

 

Page 11

 

prior written consent of Immunocore. Save as explicitly provided in this Clause 6.12, termination of a Project under this Clause 6.12 shall not affect any other licences or rights of either Party under this Agreement.

 

6.13.                   Where there is any dispute between the Parties as to whether there is any material breach of Clause 6.2 and such dispute cannot be amicably resolved between the Parties, either Party may refer the dispute to an independent expert (“Expert”) by the service of written notice on the other Party (“Dispute Notice”). During such referral, application of any notice of termination served under Clause 6.12 shall be suspended until the Expert has provided his decision. The Parties shall use reasonable endeavours to agree the Expert within fourteen (14) days of date of Dispute Notice, failing which the Expert shall be appointed by the President of the Law Society of England and Wales as soon as reasonably possible. Following appointment of Expert, both Parties shall simultaneously serve written arguments in relation to the dispute on both the Expert and the other Party within fourteen (14) days of appointment of Expert. Within a further period of fourteen (14) days from date of service of written arguments, each Party may serve a further written reply on both the Expert and other Party. The Expert will make his decision based on the exchanged written statements and shall issue his decision in writing to both Parties within a period of fourteen (14) days of service of last reply from a Party. The decision of the Expert shall be final and binding on the Parties, save for any manifest errors contained on the face of his decision. Unless otherwise provided by the Expert, the Expert’s charges shall be borne equally by the Parties. Where Expert finds there has been any material breach of Clause 6.2, any notice of termination shall continue for any remaining unexpired period in accordance with Clause 6.12 above. Where an Expert finds there has not been any material breach, any notice of termination shall cease and have no effect.

 

6.14.                   Either Party may terminate its involvement in a Project without cause and with immediate effect.  Where the terminating Party is Immunocore, termination of the Project shall result in the Results which relate solely to that Project being removed from the licence under Clause 3.2 and Immunocore shall cease to be licensed under such Results from the date of termination. Any further use of such Results by Immunocore shall require the prior written consent of Adaptimmune.  Where the terminating Party is Adaptimmune, termination of the Project shall result in the Results which relate solely to that Project being removed from the licence under Clause 3.1 and Adaptimmune shall cease to be licensed under such Results from the date of termination. Any further use of such Results by Adaptimmune shall require the prior written consent of Immunocore. Save as explicitly provided in this Clause 6.142, termination of a Project under this Clause 6.14 shall not affect any other licences or rights of either Party under this Agreement.

 

 

 

7.                                     Confidentiality

 

7.1.       Subject to the remaining provisions of this Clause 7, each Party will keep confidential the Confidential Information and will not disclose or supply that Confidential Information to any third Party or use it for any purpose except in accordance with the terms of this Agreement.

 

7.2.                          Both Parties may disclose Confidential Information to Authorised Parties to the extent reasonably necessary for the development, manufacture, Marketing or use of Licensed Products or to facilitate acquisition or merger of either Party, provided that both Parties will ensure that such Authorised Parties accept a 

 

 

Page 12

 

continuing obligation of confidentiality in terms at least as strict as those set out in this Agreement before making any such disclosure.  Each Party shall be responsible to the other Party under this Agreement in relation to any breach of confidentiality by any Authorised Party as if such breach had occurred under this Agreement.

 

7.3.      The duty of non-disclosure in Clause 7.1 will not apply to any Confidential Information which:

 

7.3.1.               is or becomes publicly known without the fault of any Party; or

 

7.3.2.               is obtained from a third Party in circumstances where the Party receiving from such third Party has no reason to believe that there has been a breach of an obligation of confidentiality; or

 

7.3.3.               is approved for release in writing by an authorised representative of the other Party.

 

7.4.       The restrictions of confidentiality in Clause 7.1 will not apply to the extent that any Confidential Information is required to be disclosed by law, pursuant to an order or rule of any court of competent jurisdiction, in order to fulfil a court order or rule, or pursuant to the requirements of any recognized stock exchange or any regulatory body, provided that the relevant Party gives the other Party prior written notice of such disclosure and that it discloses the Confidential Information only to the extent required to comply with such law or fulfil such order, rule or requirement and that it takes all reasonable steps to ensure, as far as it is possible to do so, the continued confidentiality of all Confidential Information disclosed.

 

8.                                     Duration and Termination

 

8.1.                          This Agreement will come into force on the Effective Date and will continue in force until the later of (a) the expiry of the last to expire of any patent within the Licensed Patents; or (b) the Know-How or Results ceasing to be confidential.

 

8.2.                          Both Parties agree and accept that where there is any breach of this Agreement, there shall be no right to terminate this Agreement and damages or other available relief shall be the only relief applicable.

 

8.3.                          Where any Party (“Defaulting Party”) becomes insolvent, admits insolvency, has a receiver appointed, voluntarily or involuntarily over substantially all of its assets, or is dissolved or liquidated (whether voluntarily or involuntarily), the other Party (“Non-Defaulting Party”) shall be entitled by notice in writing to the Defaulting Party to (a) take over and prosecute, file and maintain any or all of the Licensed Patents in its sole discretion; (b) request assignment of the Defaulting Party’s interest and title in the Licensed Patents, Know-How and Results to the Non-Defaulting Party on such terms as reflect reasonable arms’ length commercial terms including reasonable consideration for such assignment. The Defaulting Party and Non-Defaulting Party shall use best endeavours to negotiate the terms of such assignment as quickly as reasonably possible following date of notice by Non-Defaulting Party of its request for assignment. The Defaulting Party shall provide all reasonable assistance in relation to the on-going prosecution, filing and maintenance of the Licensed Patents by the Non-Defaulting Party including in relation to the transition of the filing, prosecution and maintenance of the Licensed Patents to the Non-Defaulting Party.

 

9.                                     Prior Agreements

 

 

Page 13

 

9.1.                          As of the Effective Date both Parties hereby agree that the Prior Agreements will be terminated.

 

9.2.        Each Party releases and discharges the other Party from all its duties and obligations under the Prior Agreements as of the Effective Date.

 

9.3.                          No Party shall be liable to the other Party under any terms of the Prior Agreements existing prior to the Effective Date including as relevant any and all indemnities, warranties, undertakings, covenants and representations.

 

9.4.        Each Party hereby waives all and any claims it might have against the other Party and their respective employees, officers, Affiliates and agents existing at the Effective Date so far as such claims arise under the Prior Agreements.

 

10.                              Warranties and Liability

 

10.1.      Each Party warrants to the other that it has the full right and power to enter into this Agreement.  Save as explicitly notified to the other Party at the Effective Date, each Party warrants that as at the Effective Date it has not knowingly misappropriated any third Party confidential information or knowingly infringed any third Party Intellectual Property Right.

 

10.2.                   Each Party warrants that save as explicitly otherwise provided in this Agreement (a) it has the rights to grant the licences in Clause 3 of this Agreement; and (b) it has not granted to any third Party any option, licence or right of first refusal in relation to the Licensed Patents, Results or Know-How; and (c) it has not assigned, transferred or granted any option to assign or transfer any of its rights in the Licensed Patents, Results or Know-How.

 

10.3.      Both Parties acknowledge that in entering into this Agreement they do not do so in reliance on any representation, warranty or other provision except as expressly provided in this Agreement and any conditions, warranties or other terms implied by statute or common law are excluded from this Agreement to the full extent permitted by law.

 

10.4.      Without limiting the scope of Clauses 10.1 to 10.4, neither Party gives any warranty, representation or undertaking:

 

10.4.1.                                                        as to the efficacy, usefulness or quality of the Licensed Patents, Results or Know-How;

 

10.4.2.                                                        that any of the Licensed Patents are or will be valid or subsisting or (in the case of applications) will proceed to grant; or

 

10.4.3.                                                        that the exploitation of any the Licensed Patents, Results or Know-How or the manufacture, Marketing, or use of Licensed Products or products or the exercise of any other rights granted under this Agreement will not infringe any Intellectual Property Rights or other rights of any third Party.

 

10.5.      Both Parties accept that there is no restriction imposed on the other Party in relation to the independent development of any Adaptimmune Licensed Products in the case of Adaptimmune, or Immunocore Licensed Products, in the case of Immunocore using TCRs which do not form part of any Project or which are not comprised within the Licensed Patents, Know-How or Results (“New TCRs”). In particular, subject to Clause 3, (a) each Party is free to enter into agreements with third Parties in relation to development of products comprising New TCRs; 

 

 

Page 14

 

(b) each Party is free to enter into any licence in relation to New TCRs; and (c) each Party is free to independently isolate New TCRs for Adaptimmune Licensed Products in the case of Adaptimmune, or Immunocore Licensed Products, in the case of Immunocore respectively.

 

10.6.                   The liability of either Party under this Agreement (whether arising for breach or arising in any other way out of the subject matter of this Agreement, including whether under contract or tort) will not include any indirect, incidental or consequential damages or loss (including as relevant any indirect loss of profits).

 

10.7.                   Nothing in this Agreement will operate to limit or exclude the liability of either Party for death or personal injury arising from its negligence or for liability for fraud.

 

11.                              General

 

11.1.      Each Party must take out and maintain (for the term of this Agreement) adequate product liability and other insurance in respect of its activities under this Agreement. Each Party must at the other Party’s request from time to time provide the other Party with reasonable evidence to demonstrate that it has fulfilled its obligations under this Clause. Each Party understands that such evidence may be provided to any sub-licensees or potential sub-licensees of the Party making the request for evidence.

 

11.2.      Registration of Licence.  Either Party may register its interest in the Licensed Patents with any relevant authorities in the Territory as soon as legally possible.  Neither Party shall, register a copy of this or any part of this Agreement with the relevant authority in any Territory without the prior written consent of the other Party.

 

11.3.      Use of Names.  Neither Party may use the name of the other Party in any advertising, promotional or sales literature, without the other Party’s prior written consent, such consent not to be unreasonably withheld.

 

11.4.                   Force Majeure.  If performance by either Party of any of its obligations under this Agreement 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, provided that if either Party is unable to fulfil its obligations under this Agreement for a continuous period of six months or more due to any such circumstances, the other Party may terminate this Agreement with immediate effect by serving written notice on the affected Party.

 

11.5.                   Amendments.  This Agreement may only be amended in writing signed by duly authorised representatives of the Parties.

 

11.6.                   Assignment.  Save as explicitly provided in this Clause neither Party may assign, mortgage, charge or otherwise transfer its rights or obligations under this Agreement in whole or part to any third Party without the prior written consent of the other Party which may be given or withheld at the absolute discretion of the other Party.  Either Party may assign some or all of its rights and obligations under this Agreement (including as relevant its interest in a Licensed Patent) to (a) a successor in title to substantially all the assets or business of the relevant Party; or (b) an Affiliate. Any such assignment shall be subject to the terms of this Agreement.

 

11.7.                   No Waiver.  No failure or delay on the part of either Party to exercise any right or remedy under this Agreement will be construed or operate as a waiver thereof, 

 

 

Page 15

 

nor will any single or partial exercise of any right or remedy preclude the further exercise of such right or remedy.

 

11.8.                   No Agency.  Neither Party may act or describe itself as the agent of the other, nor may it make or represent that it has authority to make any commitments on the other’s behalf.  Nothing in this Agreement creates, implies or evidences any partnership or joint venture between Immunocore and Adaptimmune or the relationship between them of principal and agent.

 

11.9.                   Notices.  Any notice to be given under this Agreement must be given in writing and must be delivered personally or sent by first class mail or reputable courier to the address of the relevant Party, set out at the head of this Agreement, or such other address as that Party may from time to time notify to the other Party in accordance with this Clause, marked for the attention of the Managing Director (or equivalent) in each case.  Notices sent as above will be deemed to have been received at the time of delivery (if delivered personally or by courier on any day which is a working day in the country in which the notice is delivered and otherwise on the next working day) and three working days after the date of posting (if sent by first class mail).

 

11.10.            Further Assurance.  Each Party agrees to execute, acknowledge and deliver such further instruments, and do all further similar acts, as may be necessary or appropriate to carry out the purposes and intent of this Agreement.

 

11.11.            Announcements.  Except to the extent required by applicable laws or regulations, neither Party may make any press or other public announcement concerning any aspect of this Agreement, or make any use of the name of the other Party in connection with or in consequence of this Agreement, without the prior written consent of the other Party.

 

11.12.            Entire Agreement.  This Agreement (including its schedules) sets out the entire agreement between the Parties relating to its subject matter and supersedes all prior oral or written agreements, arrangements or understandings between them relating to such subject matter.  Except in the case of fraud, the Parties acknowledge they are not relying on any representation, agreement, term or condition which is not set out in this Agreement.

 

11.13.            Severability.  If any Clause or part of any Clause in this Agreement is declared invalid or unenforceable by the judgement or decree by consent or otherwise of any court or authority of competent jurisdiction from whose decision no appeal is or can be taken, all other Clauses or parts of Clauses contained in this Agreement will remain in full force and effect and will not be affected thereby for the term of this Agreement, but the Parties will negotiate appropriate amendments to this Agreement with a view to restoring the balance of commercial interests as it stood prior to such invalidity or unenforceability being declared.

 

11.14.            Rights of Third Parties.  No person who is not a Party to this Agreement has any right to prevent the variation or cancellation of any provision of this Agreement or its termination, and no person who is not a Party to this Agreement may enforce any benefit conferred upon.

 

 

Page 16

 

11.15.            Law and Jurisdiction.  This Agreement is made and will be construed in accordance with the laws of England and Wales, and the Parties submit to the exclusive jurisdiction of the English courts, except that a Party may seek an interim or emergency injunction in any court of competent jurisdiction.

 

EXECUTED AS A DEED by the authorised representatives of the Parties on the date set out above.

 

	
EXECUTED as a deed for and on behalf of 
    IMMUNOCORE LIMITED
    	
 
    	
EXECUTED as a deed for and on behalf of
    ADAPTIMMUNE LIMITED
    
	
 
    	
 
    	
 
    
	
Name: James Noble
    	
 
    	
Name: James Noble
    
	
 
    	
 
    	
 
    
	
Position: CEO, Chairman
    	
 
    	
Position: CEO, Chairman
    
	
 
    	
 
    	
 
    
	
Signature: /s/ James Noble
    	
 
    	
Signature: /s/ James Noble
    
	
 
    	
 
    	
 
    
	
 

 

In the presence of:
    	
 
    	
 

 

In the presence of:
    
	
 
    	
 
    	
 
    
	
Name of witness: Tracey Johnson
    	
 
    	
Name of witness: Tracey Johnson
    
	
 
    	
 
    	
 
    
	
Signature of witness:

 

/s/ Tracey Johnson
    	
 
    	
Signature of witness:

 

/s/ Tracey Johnson
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Address and occupation of   witness:

 

Executive Assistant
    	
 
    	
Address and occupation of   witness:

 

Executive Assistant
    

 

 

Page 17

 

SCHEDULE 1 – LICENSED PATENTS

 

 

Status column is included for information only and is as at Effective Date.

 

	
Case Ref.
    	
 
    	
 
    	
Official No.
    	
 
    	
 
    	
Title
    	
 
    	
 
    	
Case Status
    	
 
    	
 
    	
Designation
   for
   purposes of
   Schedule 3
    
	
Case 14 monoclonal TCRs (P32566 / 44172.00.2008)
    
	
Case14-WO
    	
 
    	
 
    	
WO 2003/020763
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
International phase complete
    	
 
    	
 
    	
Core
    
	
Case14-AU
    	
 
    	
 
    	
2002321581
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case14-CA
    	
 
    	
 
    	
2457652
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case14-CN
    	
 
    	
 
    	
02819279.6
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case14-EA
    	
 
    	
 
    	
006601
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case14-EP
    	
 
    	
 
    	
1421115
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
EP Granted (AT, BE, CH, CZ, DE, DK,   EE, ES, FI, FR, GB, GR, IE, IT, NL, PT, SE, TR)
    	
 
    	
 
    	
Core
    
	
Case14-HK
    	
 
    	
 
    	
1066018
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case14-M
    	
 
    	
 
    	
160359
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case14-IN
    	
 
    	
 
    	
212621
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case14-JP
    	
 
    	
 
    	
4317940
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case14-KR
    	
 
    	
 
    	
10-0945977
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case14-MX
    	
 
    	
 
    	
246738
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case14-NO
    	
 
    	
 
    	
331877
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case14-NZ
    	
 
    	
 
    	
531208
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case14-PL
    	
 
    	
 
    	
208712
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case14-SG
    	
 
    	
 
    	
102850
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case14-US
    	
 
    	
 
    	
7329731
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case14-US1
    	
 
    	
 
    	
7763718
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case14-ZA
    	
 
    	
 
    	
2004/1197
    	
 
    	
 
    	
Soluble T cell receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case 18 scTCR (P53462 / 44172.00.2012)
    
	
Case18-WO
    	
 
    	
 
    	
WO2004/033685
    	
 
    	
 
    	
Single chain recombinant  T cell receptors
    	
 
    	
 
    	
International phase complete
    	
 
    	
 
    	
Core
    

 

 

Page 18

 

	
Case18-AU
    	
 
    	
 
    	
2003271904

 
    	
 
    	
 
    	
Single chain recombinant  T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case18-CA
    	
 
    	
 
    	
2501870

 
    	
 
    	
 
    	
Single chain recombinant  T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case18-CN
    	
 
    	
 
    	
200380101143.1

 
    	
 
    	
 
    	
Single chain recombinant  T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case18-EP
    	
 
    	
 
    	
03753742.0

 
    	
 
    	
 
    	
Single chain recombinant  T cell receptors
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Core
    
	
Case18-JP
    	
 
    	
 
    	
4436319

 
    	
 
    	
 
    	
Single chain recombinant  T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case18-IL
    	
 
    	
 
    	
167652

 
    	
 
    	
 
    	
Single chain recombinant  T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case18-IN
    	
 
    	
 
    	
227369

 
    	
 
    	
 
    	
Single chain recombinant  T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case18-NO
    	
 
    	
 
    	
2005/2198

 
    	
 
    	
 
    	
Single chain recombinant  T cell receptors
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Core
    
	
Case18-NZ
    	
 
    	
 
    	
539225

 
    	
 
    	
 
    	
Single chain recombinant  T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case18-RU
    	
 
    	
 
    	
2355703

 
    	
 
    	
 
    	
Single chain recombinant  T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case18-US
    	
 
    	
 
    	
7569664

 
    	
 
    	
 
    	
Single chain recombinant  T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case18-ZA
    	
 
    	
 
    	
2005/02927
    	
 
    	
 
    	
Single chain recombinant  T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case 19 phage display (P53469 / 44172.00.2009)
    
	
Case19-WO
    	
 
    	
 
    	
WO2004/044004
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
International phase complete
    	
 
    	
 
    	
Core
    
	
Case19-AU
    	
 
    	
 
    	
2003276403
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case19-AU1
    	
 
    	
 
    	
2010202953
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case19-CA
    	
 
    	
 
    	
2505558
    	
 
    	
 
    	
T cell receptor 
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Core
    

 

 

Page 19

 

	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
display
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Case19-CA1
    	
 
    	
 
    	
TBC
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Core
    
	
Case19-CN
    	
 
    	
 
    	
ZL200380102928.0
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case19-CN1
    	
 
    	
 
    	
CN101935636A
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
Abandoned
    	
 
    	
 
    	
Core
    
	
Case19-EP
    	
 
    	
 
    	
1558643
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
EP Granted (AT, BE, CH, CZ, DE, DK,   ES, FI, FR, GB, GR, IE, IT, NL, PT, SE, TR)
    	
 
    	
 
    	
Core
    
	
Case19-EP1
    	
 
    	
 
    	
09001469.7
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Core
    
	
Case19-IL
    	
 
    	
 
    	
167745
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case19-IN
    	
 
    	
 
    	
232673
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case19-JP
    	
 
    	
 
    	
4975324
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case19-NO
    	
 
    	
 
    	
20052743
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case19-NZ
    	
 
    	
 
    	
539226
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case19-NZ1
    	
 
    	
 
    	
570811
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case19-RU
    	
 
    	
 
    	
2346004
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case19-US1
    	
 
    	
 
    	
US 2010-0113300 A1
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Core
    
	
Case19-ZA
    	
 
    	
 
    	
2005/03336
    	
 
    	
 
    	
T cell receptor display
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case 30 CD1 binding mTCRs (P53507 / 44172.00.2013)
    
	
Case30-WO
    	
 
    	
 
    	
WO2004/074322
    	
 
    	
 
    	
Modified T cell Receptor
    	
 
    	
 
    	
International phase complete
    	
 
    	
 
    	
Full Application
    
	
Case30-AU
    	
 
    	
 
    	
2003254443
    	
 
    	
 
    	
Modified T cell Receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case30-CA
    	
 
    	
 
    	
2516702
    	
 
    	
 
    	
Modified T cell Receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case30-CN
    	
 
    	
 
    	
ZL 03826014.X
    	
 
    	
 
    	
Modified T cell Receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case30-EP
    	
 
    	
 
    	
1594896
    	
 
    	
 
    	
Modified T cell Receptor
    	
 
    	
 
    	
Granted/Registered (DE, FR, GB)
    	
 
    	
 
    	
Full Application
    
	
Case30-JP
    	
 
    	
 
    	
4478034
    	
 
    	
 
    	
Modified T cell Receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case30-NZ
    	
 
    	
 
    	
541596
    	
 
    	
 
    	
Modified T cell Receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case30-US
    	
 
    	
 
    	
7666604
    	
 
    	
 
    	
Modified T cell Receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case30-ZA
    	
 
    	
 
    	
2005/06516
    	
 
    	
 
    	
Modified T cell Receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case 53 CDR2 (P53600 / 44172.00.2010)
    
	
Case53-WO
    	
 
    	
 
    	
WO2005/114215
    	
 
    	
 
    	
Method of improving T cell receptors
    	
 
    	
 
    	
International phase complete
    	
 
    	
 
    	
Core
    
	
Case53-AU
    	
 
    	
 
    	
2005246073
    	
 
    	
 
    	
Method of improving T 
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    

 

 

Page 20

 

	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
cell receptors
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Case53-CA
    	
 
    	
 
    	
2567349
    	
 
    	
 
    	
Method of improving T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case53-CN
    	
 
    	
 
    	
200580015878.1
    	
 
    	
 
    	
Method of improving T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case53-EP
    	
 
    	
 
    	
1756278
    	
 
    	
 
    	
Method of improving T cell receptors
    	
 
    	
 
    	
EP Granted (CH, DE, FR, GB, IE)
    	
 
    	
 
    	
Core
    
	
Case53-HK
    	
 
    	
 
    	
1105995
    	
 
    	
 
    	
Method of improving T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case53-JP
    	
 
    	
 
    	
4972549
    	
 
    	
 
    	
Method of improving T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case53-NZ
    	
 
    	
 
    	
550815
    	
 
    	
 
    	
Method of improving T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case53-US
    	
 
    	
 
    	
7608410
    	
 
    	
 
    	
Method of improving T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case53-ZA
    	
 
    	
 
    	
2006/09462
    	
 
    	
 
    	
Method of improving T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Core
    
	
Case 58 mTCR adoptive therapy (P53612 / 44172.00.2003)
    
	
Case58-WO
    	
 
    	
 
    	
WO2006/000830
    	
 
    	
 
    	
Cells expressing a modified T cell   receptor
    	
 
    	
 
    	
International phase complete
    	
 
    	
 
    	
Full Application
    
	
Case58-EP
    	
 
    	
 
    	
1791865
    	
 
    	
 
    	
Cells expressing a modified T cell   receptor
    	
 
    	
 
    	
EP Granted (AT, BE, CH, DE, DK, ES,   FR, GB, IE, IT, LU, NL, SE)
    	
 
    	
 
    	
Full Application
    
	
Case58-JP
    	
 
    	
 
    	
2007-518692
    	
 
    	
 
    	
Cells expressing a modified T cell   receptor
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Full Application
    
	
Case58-US
    	
 
    	
 
    	
8361794
    	
 
    	
 
    	
Cells expressing a modified T cell   receptor
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case58-US1
    	
 
    	
 
    	
13/716817
    	
 
    	
 
    	
Cells expressing a modified T cell   receptor
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Full Application
    
	
Case 74 HIV gag (P53593 / 44172.00.2007)
    
	
Case74-WO
    	
 
    	
 
    	
WO2006/103429
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
International phase complete
    	
 
    	
 
    	
Full Application
    
	
Case74-AU
    	
 
    	
 
    	
2006228308
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case74-AU1
    	
 
    	
 
    	
2012211503
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Full Application
    

 

 

Page 21

 

	
Case74-AU2
    	
 
    	
 
    	
TBC
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Full Application
    
	
Case74-CA
    	
 
    	
 
    	
2602463
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Full Application
    
	
Case74-CN
    	
 
    	
 
    	
200680011470.1
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Full Application
    
	
Case74-CN1
    	
 
    	
 
    	
201210563915.4
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Full Application
    
	
Case74-EP
    	
 
    	
 
    	
06726555.3
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
Under Appeal
    	
 
    	
 
    	
Full Application
    
	
Case74-EP1
    	
 
    	
 
    	
10008612.3
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Full Application
    
	
Case74-EP2
    	
 
    	
 
    	
10014971.5
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Full Application
    
	
Case74-JP
    	
 
    	
 
    	
2008-503585
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Full Application
    
	
Case74-JP1
    	
 
    	
 
    	
2012-49174
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Full Application
    
	
Case74-NZ
    	
 
    	
 
    	
561338
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case74-NZ1
    	
 
    	
 
    	
584523
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case74-US
    	
 
    	
 
    	
8378074
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case74-US1
    	
 
    	
 
    	
11/733545
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Full Application
    
	
Case74-ZA
    	
 
    	
 
    	
2007/08037
    	
 
    	
 
    	
High affinity HIV T cell receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case 77 Melan A (P53578 / 44172.00.2006)
    
	
Case77-WO
    	
 
    	
 
    	
WO2006/129085
    	
 
    	
 
    	
High affinity Melan-A T cell   receptors
    	
 
    	
 
    	
International phase complete
    	
 
    	
 
    	
Full Application
    
	
Case77-AU
    	
 
    	
 
    	
2006253941
    	
 
    	
 
    	
High affinity Melan-A T cell   receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case77-CA
    	
 
    	
 
    	
2610786
    	
 
    	
 
    	
High affinity Melan-A T cell   receptors
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Full Application
    
	
Case77-CN
    	
 
    	
 
    	
ZL200680019562.4
    	
 
    	
 
    	
High affinity Melan-A T cell   receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case77-EP
    	
 
    	
 
    	
06744042.0
    	
 
    	
 
    	
High affinity 
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Full 
    

 

 

Page 22

 

	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Melan-A T cell receptors
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Application
    
	
Case77-JP
    	
 
    	
 
    	
2008-514187
    	
 
    	
 
    	
High affinity Melan-A T cell   receptors
    	
 
    	
 
    	
Abandoned
    	
 
    	
 
    	
Full Application
    
	
Case77-US
    	
 
    	
 
    	
8217144
    	
 
    	
 
    	
High affinity Melan-A T cell   receptors
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case 82 VYG Telomerase (P53589 / 44172.00.2014)
    
	
Case82-WO
    	
 
    	
 
    	
WO2006/125962
    	
 
    	
 
    	
T cells receptors which specifically   bind to VYGFVRACL-HLA-24
    	
 
    	
 
    	
International phase complete
    	
 
    	
 
    	
Full Application
    
	
Case82-CN
    	
 
    	
 
    	
200680018255.4 
    	
 
    	
 
    	
T cells receptors which specifically   bind to VYGFVRACL-HLA-24
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case82-EP
    	
 
    	
 
    	
1885754
    	
 
    	
 
    	
T cells receptors which specifically   bind to VYGFVRACL-HLA-24
    	
 
    	
 
    	
Granted/Registered (DE, ES, FR,   GB, IT)
    	
 
    	
 
    	
Full Application
    
	
Case82-JP
    	
 
    	
 
    	
5149789
    	
 
    	
 
    	
T cells receptors which specifically   bind to VYGFVRACL-HLA-24
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case82-US
    	
 
    	
 
    	
8017730
    	
 
    	
 
    	
T cells receptors which specifically   bind to VYGFVRACL-HLA-24
    	
 
    	
 
    	
Granted/Registered
    	
 
    	
 
    	
Full Application
    
	
Case 91 kinetic window (P53583 / 44172.00.2004)
    
	
Case91-WO
    	
 
    	
 
    	
WO2008/038002
    	
 
    	
 
    	
T Cell Therapies
    	
 
    	
 
    	
International phase complete
    	
 
    	
 
    	
Full Application
    
	
Case91-EP
    	
 
    	
 
    	
07823938.1
    	
 
    	
 
    	
T Cell Therapies
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Full Application
    
	
Case91-US
    	
 
    	
 
    	
12/443078
    	
 
    	
 
    	
T Cell Therapies
    	
 
    	
 
    	
Under Examination
    	
 
    	
 
    	
Full Application
    
	
Case 120 alanine scanning (P56242)
    
	
Case120-GB
    	
 
    	
 
    	
1223172.6
    	
 
    	
 
    	
Method of identifying cross reactive   peptides
    	
 
    	
 
    	
Application filed
    	
 
    	
 
    	
Core
    
	
Case 121 Improved TCR Isolation Method (P56602 /  44172.00.2018)
    
	
Case121-
    	
 
    	
 
    	
1304687.5
    	
 
    	
 
    	
Method of Identifying TCRs
    	
 
    	
 
    	
Application Filed
    	
 
    	
 
    	
Core
    

 

 

Page 23

 

	
GB
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Case121-US
    	
 
    	
 
    	
61/788,491
    	
 
    	
 
    	
TCR Libraries
    	
 
    	
 
    	
Provisional application filed
    	
 
    	
 
    	
Core
    

 

 

Page 24

 

 

SCHEDULE 2

 

know-how

 

know-how shall include the following:

 

	
1.
    	
confidential information   relating to the selection of target peptide-MHCs;
    
	
 
    	
 
    
	
2.
    	
T-cell lines and clones;
    
	
 
    	
 
    
	
3.
    	
Genes encoding T-cell receptors   and vectors encoding such genes;
    
	
 
    	
 
    
	
4.
    	
confidential information   relating to T-cell receptor design, engineering and production by any method;
    
	
 
    	
 
    
	
5.
    	
confidential information   relating to production of soluble T-cell receptors;
    
	
 
    	
 
    
	
6.
    	
confidential information   relating to production of soluble T-cell receptors linked to other reagents;
    
	
 
    	
 
    
	
7.
    	
confidential information   relating to the determination of the affinity and kinetic characteristics of   T-cell receptors/pMHC interactions;
    
	
 
    	
 
    
	
8.
    	
confidential information   relating to the transfection of cells with genes encoding T-cell receptors   including transfected cell lines;
    
	
 
    	
 
    
	
9.
    	
confidential information   relating to phage display-based generation and selection of high affinity   T-cell receptors;
    
	
 
    	
 
    
	
10.
    	
confidential information   relating to the design, conduct and interpretation of T cell assays with   soluble T-cell receptors or adoptively transferred T-cell receptors in cells;
    

 

 

SCHEDULE 3

 

 

PATENT PROCESS

 

Where any Notification is received under Clause 4.2 of this Agreement, any resulting patent or patent application will be filed, prosecuted and maintained in accordance with the following process. Performance of and decisions taken in relation to any notified invention, Provisional Application, Full Application or Later Application may be recorded and approved in accordance with the template set out in Schedule 5.

 

In relation to Licensed Patents filed as at the Effective Date, Schedule 3 shall apply to such patents and patent applications in accordance with the designation set out in Schedule 1.

 

1.            Any Notification shall specify a summary of the invention in relation to which the patent application is proposed to be filed.

 

2.            The Parties may agree not to file a patent application in relation to any Notification. If no patent application is filed then the relevant invention shall be maintained as confidential in accordance with Clause 7 of this Agreement.

 

3.            Where the Parties do not agree to maintain the notified invention as confidential, then Immunocore shall be responsible for the filing of the patent application (“Provisional Application”).  The Provisional Application shall be filed in the joint names of both Parties.

 

4.            The Parties will use all reasonable endeavours to agree the contents of the Provisional Application within 3 months of original notification under paragraph 1 above (or where any Provisional Application is being filed or re-filed in accordance with paragraph 5 below, within a period of twelve (12) months from filing date of original Provisional Application). Any disagreement as to scope and content of Provisional Application shall be resolved in favour of Adaptimmune. The Provisional Application shall be filed as a minimum with the UK Intellectual Property Office.

 

5.            Within a period of twelve (12) months from filing date of Provisional Application the Parties shall agree whether to (a) file a full patent application or applications corresponding to the Provisional Application; or (b) add additional matter to any Provisional Application; or (c) withdraw any Provisional Application and maintain the contents and invention as confidential; or (d) withdraw any Provisional Application and re-file the same application or a variation of such application. Where the Provisional Application or a variation of such application is re-filed the provisions of this Schedule 3 shall apply as if such re-filed application was the first Provisional Application. The content of any additional matter added to any Provisional Application shall be agreed by both Parties. Any disagreement as to whether or not the Provisional Application is withdrawn, a full patent application filed or the Provisional Application re-filed or the content of any Provisional Application shall be resolved in favour of Adaptimmune.

 

6.            Where the Parties agree to file a full patent application or applications corresponding to any Provisional Application, Immunocore shall file a full patent application or applications corresponding to the Provisional Application (“Full Application”). Both Parties will use reasonable endeavours to agree on the contents of the Full Application. Any disagreement as to scope and content of Full Application will be resolved in favour of Adaptimmune if the Full

 

 

Page 26

 

 

Application contains Adaptimmune-only mutations. If the content of the Full Application contains both Immunocore and Adaptimmune mutations, any disagreement as to scope and content of the Full Application shall be resolved in favour of Immunocore save that Immunocore shall be obliged to include all mutations or combinations of mutations in the Full Application as are requested to be included by Adaptimmune. For the avoidance of doubt, the Full Application may be identical in content to the Provisional Application.

 

7.            The Full Application shall be filed as an application in accordance with the Patent Co-operation Treaty. The Full Application shall be filed in the joint names of both Parties. The Parties shall agree which filing strategy is appropriate in each case. In the event of any failure to agree, an application in accordance with the Patent Co-operation Treaty at the UK Intellectual Property Office shall be filed as far as possible specifying all Patent Co-operation Treaty countries.

 

8.            Immunocore shall be responsible for the filing, prosecution and maintenance of the Full Application in accordance with the following:

 

a.    use best endeavours to file, obtain and maintain valid patents pursuant to the Full Application so as to secure the broadest monopoly reasonably available in the countries chosen by Immunocore after consultation with Adaptimmune. Such countries shall include as a minimum the Required Countries unless otherwise agreed with Adaptimmune in writing;

b.    ensure that Adaptimmune is kept fully informed, and consult with Adaptimmune in relation to all matters relating to the filing, prosecution and maintenance of the Full Application; and

c.    supply Adaptimmune with copies of all correspondence to and from Patent Offices in respect of the Full Application, including copies of all documents generated in or with such correspondence.

 

9.            Where any later filed patent application relates to the same TCR or subject matter as any previously filed Provisional Application or Full Application (“Later Application”), the following will apply:

 

a.    The Parties shall use reasonable endeavours to agree on the contents of the Later Application within thirty (30) days of notification of Later Application under paragraph 1. Any disagreement as to scope and content of Later Application shall be resolved in favour of Immunocore save that Immunocore shall be obliged to include all mutations or combinations of mutations in the Later Application as are requested to be included by Adaptimmune;

b.    Prior to publication of the subject matter of the earlier of the Provisional Application or Full Application, the Parties shall discuss and agree whether the Provisional Application, Full Application and any Later Application should be withdrawn and re-filed to incorporate subject matter and/or claims from all of the Provisional Application, Full Application and Later Application. The Parties agree that where any Full Application or Later Application which has been filed relates to any Adaptimmune Product in relation to which clinical trials have been started or in relation to which a clinical trial is pending, the Full Application or Later Application shall not be withdrawn and re-filed.

c.    Where the Parties do not agree in relation to the withdrawal and re-filing of the Provisional Application, Full Application and any Later Application or the contents of any re-filed Later Application, Immunocore shall have the right to file the Later Application but shall be obliged to include all mutations or combinations of mutations requested to be included by

 

 

Page 27

 

 

Adaptimmune. Adaptimmune shall provide all its requested mutations and combinations of mutations within fourteen (14) days of written request from Immunocore. Pending receipt of such request, Immunocore will not file the Later Application or do anything which may jeopardise the filing, prosecution or maintenance of the Later Application.

d.    Where the Parties agree that the Later Application should be withdrawn, Immunocore will withdraw the Later Application prior to its publication and the contents shall be maintained as confidential in accordance with Clause 7 of this Agreement. The Provisional Application and/or Full Application shall continue to be filed, maintained and prosecuted in accordance with paragraph 7 above.

 

10.          Where the Parties agree to withdraw any Full Application and/or Provisional Application and/or Later Application and re-file or file the Later Application, the Parties shall use reasonable endeavours to agree the subject matter of such Later Application within a period of thirty (30) business days from agreement to withdraw and re-file. Any dispute shall be resolved in favour of Immunocore save that Immunocore shall be obliged to include all mutations or combinations of mutations in the Later Application as are requested to be included by Adaptimmune within such thirty (30) day period. Once the contents of the Later Application are agreed or deemed agreed, Immunocore shall be responsible for the filing, prosecution and maintenance of the Later Application. The Later Application shall be filed in the joint names of the Parties and Immunocore shall file, prosecute and maintain such application in accordance with the following:

 

a.    use best endeavours to file, obtain and maintain valid patents pursuant to the Later Application so as to secure the broadest monopoly reasonably available in the countries chosen by Immunocore after consultation with Adaptimmune. Such countries shall include as a minimum the Required Countries unless otherwise agreed with Adaptimmune in writing;

b.    ensure that Adaptimmune is kept fully informed, and consult with Adaptimmune in relation to all matters relating to the filing, prosecution and maintenance of the Later Application; and

c.    supply Adaptimmune with copies of all correspondence to and from Patent Offices in respect of the Later Application, including copies of all documents generated in or with such correspondence.

 

Immunocore shall not be entitled to remove any mutations or combinations of mutations from the claims of any Later Application or re-filed Later Application (or any patent, patent application, divisional or continuation of such Later Application or re-filed Later Application) without the prior written consent of Adaptimmune unless any relevant patent office has provided a final non-appealable opinion that such mutation or combination of mutations is not patentable or capable of patent protection.

 

11.          Immunocore shall maintain Granted Patents in accordance with the following:

 

a.    Use best endeavours to maintain valid patents pursuant to the Granted Patents to the extent valid patents have not already been granted as at the Effective Date;

b.    Pay all renewal and grant fees associated with such Granted Patents in the country in which such Granted Patent has been granted as at the Effective Date or in relation to which the Granted Patent is granted subsequent to the Effective Date;

 

 

Page 28

 

 

c.    Ensure that Adaptimmune is kept fully informed of any substantive communications in relation to such Granted Patents including communications and payment of renewal and grant fees.

 

The provisions of paragraphs 1-10 of this Schedule 3 shall not apply to any Granted Patents.

 

12.          There shall be no obligation on either Party to maintain, prosecute, seek to re-instate, reissue or otherwise re-file any Lapsed Patent (as designated in accordance with Schedule 1) and the obligations set out under Schedule 3 shall not apply to any Lapsed Patents.

 

13.          Immunocore shall file, prosecute and maintain Core Patents in accordance with the following:

 

a.    Use best endeavours to file, obtain and maintain valid patents pursuant to the Core Patents so as to secure the broadest monopoly reasonably available in countries chosen by Immunocore, but at a minimum including the Required Countries unless otherwise agreed in writing with Adaptimmune;

b.    To the extent such Core Patents are granted in any countries as at the Effective Date, to pay all renewal and grant fees associated with such granted Core Patents in the country in which such Core Patent has been granted as at the Effective Date;

c.    Ensure that Adaptimmune is kept fully informed and to the extent reasonably possible consult with Adaptimmune in relation to any substantive communications to or from any Patent Office in relation to such Core Patents.

 

Adaptimmune understands and accepts that subject to the obligations imposed under this paragraph 13, Immunocore has the final decision in relation to the content of the Core Patents and the content of any communications relating to such Core Patents with any Patent Office.

 

The provisions of paragraphs 1-10 of this Schedule 3 shall not apply to any Core Patents.

 

 

14.          Adaptimmune will reimburse Immunocore, within 30 days of the date of an invoice from Immunocore, for fifty per cent (50%) of the reasonable costs (including patent agent costs), fees and charges incurred by Immunocore in the course of filing, prosecuting and maintaining the patents and patent applications in accordance with this Schedule 3 (including as relevant Granted Patents and Core Patents).  Such invoice will set out an itemised list of the costs incurred by Immunocore to a level of detail reasonably satisfactory to Adaptimmune. Adaptimmune may also request copies of invoices received from third Parties including patent agent costs.

 

15.          If, at any time during the term of this Agreement, either Party (“Notifying Party”) no longer wishes to prosecute, file or maintain any of the Licensed Patents, it shall provide at least thirty (30) days’ notice to the other Party (“Recipient Party”). The Recipient Party shall be entitled in its sole discretion to take over and prosecute, file and maintain any notified patent or patent application. The Recipient Party shall make such decision within thirty (30) days of receiving notice from the Notifying Party. The Notifying Party shall assign its rights in such notified patent or patent application to the Recipient Party and the Notifying Party agrees to use all reasonable endeavours to

 

 

Page 29

 

 

consent to and procure the signing of all documentation required to transfer full title in the notified patent or patent application to the Recipient Party. Following assignment, the Recipient Party shall be solely responsible for controlling and paying all the costs of prosecution, filing and maintenance of the assigned patent or patent application. Following assignment the Notifying Party shall have no further interest in the invention and patent or patent application shall be removed from the definition of Licensed Patents.

 

16.          Where Recipient Party states in writing that it does not want to take over and prosecute, file and maintain any patent or patent application notified under paragraph 15 above, Notifying Party shall be entitled to allow such patent or patent application to lapse either through non-response to any office action or through non-payment of any fees due and payable in relation to such patent or patent application or by withdrawal of such patent or patent application. Where such patent or patent application has not been published as of the date the Recipient Party states it does not want to take over the prosecution, filing and maintenance, the Notifying Party shall use reasonable efforts to procure lapse or withdrawal of the Licensed Patent prior to its publication.

 

17.          Prior to any decision being made by Recipient Party under paragraph 15 above, Immunocore or as relevant Adaptimmune (where Adaptimmune has taken over filing, prosecution and maintenance under paragraph 20 below) shall continue to prosecute, file and maintain the relevant patent or patent application in accordance with paragraphs 8, 10, 11 and 13 above (as relevant) and shall not do anything to jeopardise the filing, prosecution and maintenance of such patent or patent application.

 

18.          Each Party will inform the other Party promptly if it becomes aware of any opposition, revocation, re-examination, interference or other action attacking or challenging the validity of any of the Licensed Patents. Where such challenge relates solely to claims covering Adaptimmune Licensed Products, Adaptimmune shall be entitled (but not obliged) to defend any such challenge. Where such challenge relates solely to claims covering Immunocore Licensed Products, Immunocore shall be entitled (but not obliged) to defend any such challenge. Where any challenge does not relate solely to either the Immunocore Licensed Products or the Adaptimmune Licensed Products or there is any dispute as to such, then (a) Adaptimmune shall be entitled (but not obliged) to defend any such challenge in relation to Provisional or Full Applications and Immunocore agrees to assist Adaptimmune in any such defence; and (b) Immunocore shall be entitled (but not obliged) to defend any such challenge in relation to any re-filed Later Application, Later Application, Granted Patent or Core Patent and Adaptimmune agrees to assist Immunocore in such defence. Where reasonably possible each Party will act in the best interests of the other Party in defending any such challenge.

 

19.          Each Party will inform the other Party promptly if it becomes aware of any infringement or potential infringement of any of the Licensed Patents in the Field, and the Parties will consult with each other to decide the best way to respond to such infringement.  If the Parties fail to agree on a joint programme of action (and as relevant the sharing of costs in relation to such joint programme) within 14 days of notification of infringement or potential infringement then the following shall apply:

a.    (i) Adaptimmune shall be entitled (but not obliged) to take action against the third Party at its sole expense for any infringement or potential infringement where such infringement or potential infringement relates to any product that contains cells that are transfected with genes encoding TCRs including any product containing cells that may also be transfected

 

 

Page 30

 

 

with one or more additional other molecules as well (whether transfected at the same time or by the same means as the TCRs or not); and (ii) any process, service or method relating solely to any product that contains cells that are transfected with genes encoding TCRs, in each case excluding any infringement or potential infringement of any Core Patent;

b.    Immunocore shall be entitled (but not obliged) to take action against the third Party at its sole expense for any infringement or potential infringement where such infringement or potential infringement relates to (i) any product that contains Soluble TCRs and any process, service or method relating to such a product; and (ii) any Core Patent.

c.    The other Party agrees to be joined in any suit to the extent necessary to enforce such rights subject to being reimbursed and secured in a reasonable manner as to any costs, damages, expenses, or other liability and shall have the right to be separately represented by its own counsel at its own expense.

 

20.          Should Immunocore fail to file, maintain or prosecute any patent or patent application in accordance with this Schedule 3, Adaptimmune may provide Immunocore with thirty (30) days’ notice of such failure. Where such failure is not corrected within the thirty (30) day notice period, Adaptimmune may serve a further written notice to take over the filing, prosecution and maintenance of such Licensed Patents. Immunocore shall provide all reasonable assistance required by Adaptimmune in relation to the transition of the filing, prosecution and maintenance of such patents and/or patent applications to Adaptimmune.

 

21.          Where Adaptimmune takes over the filing, prosecution and maintenance of any of the patents or patent applications under paragraph 20 above, paragraph 14 shall cease to apply. Adaptimmune will file, prosecute and maintain any patents or patent applications in accordance with the obligations previously imposed on Immunocore. Immunocore will reimburse Adaptimmune, within thirty (30) days of the date of an invoice from Adaptimmune, for fifty per cent (50%) of the reasonable costs (including patent agent costs), fees and charges incurred by Adaptimmune in the course of filing, prosecuting and maintaining patent and patent applications under this Schedule 3.  Such invoice will set out an itemised list of the costs incurred by the Adaptimmune to a level of detail satisfactory to the Immunocore. Immunocore may also request copies of invoices received from third Parties including patent agent costs.

 

22.          This Schedule 3 shall apply to the filing of patents and patent applications in relation to Results, Know-How or the Licensed Patents both during the term of this Agreement and following any termination or expiry of this Agreement.

 

 

Page 31

 

 

Schedule 4A

 

Project Schedule Template

 

The following information should be agreed between the Parties in relation to any Project covered by this Agreement:

 

	
Project start   date
    	
 
    	
[Insert start   date, if known]
    
	
 
    	
 
    	
 
    
	
Project ID
    	
 
    	
[Insert unique   Project ID]
    
	
 
    	
 
    	
 
    
	
Project TCR   Source
    	
 
    	
[Insert   details of TCR receptor or receptors source]
    
	
 
    	
 
    	
 
    
	
Target
    	
 
    	
[Insert detail   of relevant target or targets]
    
	
 
    	
 
    	
 
    
	
Project Scope
    	
 
    	
[insert   details of scope of project]
    
	
MHC Allele
    	
 
    	
[Insert   details of MHC allele]
    
	
Sequence of wt   epitope
    	
 
    	
[Insert wt   sequence details]
    
	
TRAV
    	
 
    	
 
    
	
TRBV
    	
 
    	
 
    
	
In-licensed
    	
 
    	
[Insert   indication as to whether any IP or materials have been in-licensed]
    
	
Project   Details
    	
 
    	
[Insert scope   of project e.g. research and determination of possible mutations in relation   to listed TCR’s]
    
	
 
    	
 
    	
 
    
	
Project   Deliverables
    	
 
    	
[Insert   project deliverables]
    
	
 
    	
 
    	
 
    
	
Project   manager assigned by Immunocore
    	
 
    	
[Insert name   of project manager]
    
	
 
    	
 
    	
 
    
	
Project   manager assigned by Adaptimmune
    	
 
    	
[Insert name   of project manager]
    
	
 
    	
 
    	
 
    
	
Assignment of   tasks and project timelines
    	
 
    	
[Insert list   of tasks to be completed by each Party along with timelines]
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Project   Completion
    	
 
    	
[Insert when   project will be completed and likely end date].
    
	
 
    	
 
    	
 
    
	
Agreed to be a   Project under Exclusive Licence by Immunocore
    	
 
    	
Signature:

 

Name:

 

Date:
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Agreed to be a   Project under Exclusive Licence by Adaptimune
    	
 
    	
Signature:

 

Name:

 

Date:
    

 

 

Schedule 4B

 

Projects agreed as at Effective Date

 

 

	
 

Unique ID
    	
TCR Source

 

 
    	
Target

 

 
    	
MHC allele

 

 
    	
Sequence of wt
   epitope

 

 
    	
 

In-
   licensed?

 

 
    
	
 

 
    
	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
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***        Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

SCHEDULE 5

 

PATENT PROCESS TEMPLATE

 

This template may be completed for each new patent family/ notification to record steps taken in accordance with this Agreement and, in particular, Schedule 3 of this Agreement. Should there be any conflict between any template and Schedule 3, the provisions of Schedule 3 shall supersede and override any template unless Schedule 3 is explicitly stated to be amended and such amendment is agreed to in writing by both Parties.

 

Immunocore agrees to use reasonable endeavours to complete this template and provide a copy to Adaptimmune following any changes or updates to this template.

 

	
Step in patent process procedure.
    	
Action/ decision
    	
Authorisation by Parties
    
	
 
    	
 
    	
 
    
	
Assigned family   number:

 

Granted patent   details when available:
    	
 
    
	
 
    	
 
    	
 
    
	
Notification of invention
    	
Notification made by:
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
Notification date:
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
Notification relates to same TCR or subject matter as previously filed   application: see template for [insert application   details/ family number] for further information.
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
Decision to maintain invention as confidential:
    	
 
    	
Agreed by Immunocore:

 

Signature:

 

Date:

 

Agreed by Adaptimmune

 

Signature:

 

Date:
    
	
 
    	
 
    	
 
    
	
 
    	
Decision to file patent application:
    	
 
    	
Agreed by Immunocore:

 

Signature:

 

Date:

 

Agreed by Adaptimmune

 

Signature:

 

Date:
    
	
 
    	
 
    	
 
    	
 
    

 

 

Page 38

 

 

	
 
    	
 
    	
 
    
	
 
    	
N.B. Where no agreement is reached between the Parties:   patent application will be filed.
    
	
 
    	
 
    	
 
    
	
Provisional Application filed
    	
Provisional Application details:

 

Date filed:

 
    	
Content agreed by Immunocore:

 

Signature:

 

Date:

 

Content agreed by Adaptimmune

 

Signature:

 

Date:
    
	
 
    	
 
    	
 
    
	
 
    	
N.B. Any dispute as to content to be resolved in favour of   Adaptimmune.
    
	
 
    
	
Provisional Application withdrawn
    	
Provisional Application details:

 

Date withdrawn:
    	
Agreed by Immunocore:

 

Signature:

 

Date:

 

Agreed by Adaptimmune

 

Signature:

 

Date:
    
	
 
    	
 
    	
 
    
	
 
    	
N.B. Any dispute to be resolved in favour of Adaptimmune.
    
	
 
    	
 
    	
 
    
	
Provisional Application withdrawn and re-filed
    	
Provisional Application details:

 

Date withdrawn:

 

Date new provisional filed:

 

New Provisional Application details:
    	
Agreed by Immunocore:

 

Signature:

 

Date:

 

Agreed by Adaptimmune

 

Signature:

 

Date:
    
	
 
    	
 
    	
 
    
	
 
    	
N.B. Any dispute to be resolved in favour of Adaptimmune.
    
	
 
    	
 
    	
 
    
	
Full Application filed
    	
Full Application details:

 

Date filed:
    	
Content agreed by Immunocore:

 

Signature:
    
	
 
    	
 
    	
 
    

 

 

Page 39

 

 

	
 
    	
 
    	
Date:

 

Content agreed by Adaptimmune

 

Signature:

 

Date:
    
	
 
    	
 
    	
 
    
	
 
    	
N.B. Any dispute as to content to be resolved in favour of   Adaptimmune.
    
	
 
    	
 
    	
 
    
	
Later Application notified
    	
Notification made by:
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
Notification date:
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
Provisional Application to be withdrawn:

 

Date withdrawn:

 
    	
Agreed by Immunocore:

 

Signature:

 

Date:

 

Agreed by Adaptimmune

 

Signature:

 

Date:
    
	
 
    	
 
    	
 
    
	
 
    	
Full Application to be withdrawn:

 

Date withdrawn:
    	
Agreed by Immunocore:

 

Signature:

 

Date:

 

Agreed by Adaptimmune

 

Signature:

 

Date:
    
	
 
    	
 
    	
 
    
	
 
    	
Later Application to be re-filed:
    	
Agreed by Immunocore:

 

Signature:

 

Date:

 

Agreed by Adaptimmune

 

Signature:

 

Date:
    
	
 
    	
 
    	
 
    
	
 
    	
Later Application re-filed:

 

Application details:
    	
Content agreed by Immunocore:

 

Signature:
    
	
 
    	
 
    	
 
    

 

 

Page 40

 

 

	
 
    	
Date filed:
    	
 

Date:

 

Content agreed by Adaptimmune

 

Signature:

 

Date:
    
	
 
    	
 
    	
 
    
	
 
    	
N.B. Where no agreement on withdrawal of Provisional   Application or Full Application, Immunocore can file Later Application   but must include all Adaptimmune requested mutations:  

 

Date   Later Application filed:

 

Application   details:
    
	
 
    	
 
    	
 
    
	
Responses to Official Actions/ Search Reports/ Examination   reports
    	
Details of office action/ notification etc:

 
    	
Response agreed by Immunocore:

 

Signature:

 

Date:

 

Response agreed by Adaptimmune

 

Signature:

 

Date:
    
	
 
    	
 
    	
 
    
	
Changes to claim scope
    	
Details of changes made/ response to office action/   opposition:
    	
Changes agreed by Immunocore:

 

Signature:

 

Date:

 

Changes agreed by Adaptimmune

 

Signature:

 

Date:
    
	
 
    	
 
    	
 
    
	
Notification that either Party wishes to cease being   involved in prosecuting/ filing or maintaining any Licensed Patent
    	
Notification made by:

 

Notification date:

 

Licensed Patent(s) affected:
    	
Agreement by other Party to take over prosecution, filing   and maintenance of Licensed Patent:

 

Signature:

 

Date:
    
	
 
    	
 
    	
 
    

 

 

Page 41

 

 

	
 
    	
Date title to patent transferred to Party taking over   prosecution, filing and maintenance of Licensed Patent:
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
If Party is not taking over prosecution, filing and   maintenance of Licensed Patent, date of lapse or withdrawal:

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00244-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00244-of-00352.parquet"}]]