[“Field” means the diagnosis, prevention and treatment of infections caused by the pathogens listed in the WHO R&D blueprint priority (December 2015 or January 2017) as updated from time to time.]
[“Approved Regulatory Authority” means the EU European Medicines Agency, the US Food and Drug Administration, SwissMedic, Japanese PMDA, Australian Therapeutic Goods Agency, South Korean Ministry of Drug Safety, Health Canada, the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) or Singapore Health Sciences Authority.]
7. Partner Obligations
7.2 Regulatory. Subject to specific Work Packages, the Partner agrees to use Reasonable Efforts develop the regulatory strategy for the Platform for use in the Field and the Project Vaccine for use in the Field, in both cases in accordance with the relevant Work Package Statement for review and approval by JMAG [Joint Monitoring and Advisory Group]. Such strategy shall include the strategy with respect to any data, market or other regulatory exclusivity periods that may be applicable in the Affected Territory or a territory which may be served by an Approved Regulatory Authority.
7.3 IND or CTA. Subject to specific Work Packages, the Partner agrees to use Reasonable Efforts to file for, obtain and maintain an IND or a CTA for Project Vaccine Developed by Partner for use in the Field in both a territory served by an Approved Regulatory Agency and the Affected Territory.
7.6 Trusted Manufacturers. Subject to the undertakings to be defined in the Additional Work Packages and – upon Partner’s request, subject to a separate confidentiality agreement to be concluded between the Partner and the Trusted Manufacturer – the Partner will support CEPI in appointing one or more Trusted Manufacturers that are technically and operationally capable of and willing to rapidly Manufacture Product for use in the Field in the Affected Territory on an ongoing basis both during and after completion of the Project, in accordance with CEPI’s requirements, as set forth herein.
7.6.1. Subject to the undertakings in the Additional Work Packages the Partner shall:
(i) grant appointed Trusted Manufacturers all necessary rights to use (on a non-exclusive, royalty-free and license-fee free basis) the Background Technology and Project Technology to further Develop the Platform, and to Manufacture Products for use in the Field in the Affected Territory in accordance with the CEPI Production Timescale and in the quantities reasonably likely to be necessary in the event of an Outbreak or risk of Outbreak in the Field and at a cost of goods in line with the methodology to determine pricing obligations set out in the CEPI Equitable Access Policy;
(ii) provide the Technology Transfer Materials to the Trusted Manufacturers and ensure that such Technology Transfer Materials are kept up to date, in particular, at each date on which the Partner requests any payment from CEPI, on the occurrence of one or more Conditions Precedent and on termination or expiration (for whatever reason) of this Agreement;
(iii) at the request of CEPI, enable Trusted Manufacturers to establish a warm base for the further Development of the Platform, and Manufacturing of Products for use in the Field in the Affected Territory;
(iv) collaborate with public sector agencies to use the Platform to Manufacture Products for use in the Field in the Affected Territory in accordance with the CEPI Production Timeframe in the quantities reasonably likely to be necessary and at a cost of goods in line with the methodology to determine pricing obligations set out in the CEPI Equitable Access Policy, in particular before any Outbreak or when there is Risk of Outbreak; and
(v) provide all necessary commercially reasonable support to the Trusted Manufacturers to facilitate the foregoing.
7.7 Partner nominees for Trusted Manufacturers. Upon CEPI’s request, Partner will use Reasonable Efforts to notify CEPI of suitable Trusted Manufacturers for appointment by CEPI.
7.8 CEPI nominees for Trusted Manufacturers. CEPI may nominate by notice in writing to Partner Third Parties as suggested Trusted Manufacturers. The Partner shall consider any Third Parties nominated by CEPI as potential Trusted Manufacturers in good faith. Where a Third Party nominated by CEPI is not acceptable to the Partner on reasonable grounds (including commercial grounds), the Partner shall notify CEPI promptly of its decision and the reasonable grounds and CEPI shall not appoint such Third Party as a Trusted Manufacturer.
7.9 Additional Trusted Manufacturers. Subject to specific Additional Work Packages, CEPI has the right during the Project Term to pursue the appointment of additional Trusted Manufacturers where such additional capacity is necessary or useful to:
7.9.1. develop and/or increase Manufacturing capacity for Products for use in the Field in the Affected Territory to satisfy demand or likely demand;
7.9.2. develop and provide warm base Manufacturing capacity for emergency planning and contingency planning;
7.9.3. Manufacture emergency stockpiles of Products for use in the Field in the Affected Territory.
Partner shall consider CEPI’s requests for additional Trusted Manufacturers in good faith and shall within [*****] of receipt of such request notify CEPI in writing whether the Partner agrees or declines to support the appointment of additional Trusted Manufacturers by CEPI together with the grounds for its decision.
7.10 Disputes as to Trusted Manufacturers. In the event that the Parties are unable to reach agreement on the identity, number and/or necessary aggregate capacity of Trusted Manufacturers, the matter shall be resolved in accordance with the dispute resolution procedure set out in Clause 22.
11. Public Health License
11.1 The Partner hereby grants to CEPI with effect from the Effective Date, a non-exclusive, worldwide, royalty-free and license-fee free license (except in respect of the sharing of Commercial Benefits pursuant to Clause 13) under the Background Technology and Project Technology to:
11.1.1. develop the Platform for use in the Field via Trusted Manufacturers;
11.1.2. Manufacture and market Product for use in the Field in the Affected Territory via Trusted Manufacturers;
11.1.3. Develop the Project Vaccine;
11.1.4. compare and contrast the relative advantages and disadvantages of the Platform and alternative platforms for use in the Field; and
11.1.5. compare and contrast the relative advantages and disadvantages of Product for use in the Field in the Affected Territory against the advantages and disadvantages of alternative equivalent products for use in the Field in the Affected Territory;
(together, the “Public Health License”); provided however that CEPI may not exercise the rights granted under the Public Health License unless and until the occurrence of one or more Conditions Precedent.
11.2 Covenant not to sue. During the term of the Public Health License under this Clause 11, Partner shall not sue CEPI, or any Third Party which holds a permitted sublicense to the Background Technology from CEPI or a sublicensee of CEPI, for infringement of any Technology Controlled by the Partner, by developing Products in the Field and for the Affected Territory, even if such Technology is not part of the Background Technology.
11.3 Third Party license fees. To the extent the Public Health License triggers payments to Third Parties, including license fees and royalty payments, CEPI shall assume these payment obligations, and reimburse any payments made by Partner for such use.
11.4 No implied licenses. Except for the rights and licenses granted to CEPI, the Partner retains all rights under its Technology.
12. Conditions Precedent And Exercise Of The Public Health License
12.1 Exercise of Public Health License. CEPI may exercise the Public Health License by notice in writing to the Partner on the occurrence of one or more of the events set out below (each a “Condition Precedent” and together the “Conditions Precedent”):
12.1.1. except where failure is due to reasonable scientific, safety or regulatory issues, the Partner:
(i) materially fails to Develop the Platform and/or the Project Vaccines in accordance with the Work Package Statements or Additional Work Package Statements as they relate to Products and/or the IPDP; or
(ii) fails to use Reasonable Efforts to satisfy any Milestone Criteria or Stage Gate Criteria by the relevant Milestone Date or Stage Gate Date; and in each case, fails to remedy the situation within [*****] of the receipt by Partner of notice from CEPI identifying the failure and requiring its remedy (or as otherwise as agreed in writing by the Parties);
12.1.2. CEPI terminates the Agreement in accordance with Clause 19.2 below.
12.1.3. in the event of an Outbreak or Outbreak risk:
(i) the Partner does not exercise the Partner Right of First Refusal or declines to enter into an agreement under Clause 8.3.1;
(ii) the Partner informs CEPI that it will not be able to Develop and Manufacture Project Vaccine in accordance with the CEPI Production Timeframe, in sufficient quantities and at an appropriate cost given the nature and health implications of the Outbreak or Outbreak risk;
(iii) the Partner’s Development and Manufacture of Project Vaccine for use in the Field does not achieve the CEPI Production Timeframe, in appropriate quantities and/or at an appropriate cost given the nature and health implications of the Outbreak or Outbreak risk; or
(iv) CEPI, in good faith, based on actual non-performance or late performance has reason to assume that the Partner is unable or unwilling to Develop or Manufacture Project Vaccine for use in the Field in sufficient quantities in accordance with the CEPI Production Timeframe and at an appropriate cost given the nature and health implications of the Outbreak or Outbreak risk;
12.1.4. if by the date [*****] following successful completion of the Project the Cost of Goods for the Project Vaccines for use in the Field exceeds the level public service agencies agree is affordable based on objective economic criteria to be determined between the Parties for use in the Affected Territory;
12.1.5. if by the date [*****] following successful completion of the Project, the Cost of Goods for a specific Project Vaccine for use in the Field exceeds the level public service agencies agree is affordable based on objective economic criteria to be determined between the Parties for use in the Affected Territories;
12.1.6. where one or more Project Vaccine becomes subject to a pattern of serious adverse events (as defined in the ICH Guidelines) or either Party receives notice from a Regulatory Authority, independent review committee, a data safety monitoring board or another similar clinical trial or post-marketing body alleging significant concern regarding a patient safety issue, in each case in which CEPI, in good faith, reasonably believes would seriously impact the long-term viability of one or more of the Project Vaccines for use in the Field;
12.1.7. there are material Safety Issues and/or quality issues in relation to use of the Platform that will seriously impact the long-term viability of the Platform; and
12.1.8. on termination of the Agreement where the Partner is the Defaulting Party.
12.2 Disputes relating to the occurrence of a Conditions Precedent. In the event that the Parties dispute the occurrence one or more of the Conditions Precedents, the matter shall be resolved in accordance with the dispute resolution procedure set out at Clause 22 provided however that any arbitration decision shall be made within [*****] of the date of the reference to arbitration.
Whilst the dispute is subject to arbitration, on the occurrence of an Outbreak in the Field and/or risk of an Outbreak in the Field, CEPI shall be entitled to exercise the Public Health License solely to have Developed Project Vaccines, and to have Manufactured and marketed Product via the Trusted Manufacturer for use in the Field in the Affected Territory to address the Outbreak or Outbreak risk. In such event, the Partner shall use all reasonable endeavors to give assistance to CEPI and/or the Trusted Manufacturer(s) including: (i) transferring to the Trusted Manufacturer(s) all Data, Materials, Confidential Information and Regulatory Filings (including the Master File) necessary or desirable for CEPI to conduct such Development of Products including Project Vaccines, Manufacturing and marketing; and (ii) executing any necessary documents.
12.3 Effects of exercise of the Public Health License. On exercise of the Public Health License, CEPI, after consultation with Partner, shall have the discretion to make any reasonable decisions in relation to the Development of the Platform for use in the Field, the Development of Products including Project Vaccine, Manufacturing and marketing of the Product for use in the Field in the Affected Territory by the Trusted Manufacturer(s). The Partner shall use all reasonable endeavors to give assistance to CEPI and/or the Trusted Manufacturer(s) in relation to such Manufacturing for use in the Field in the Affected Territory including executing any necessary documents.
12.4 Rights of action. Following exercise of the Public Health License, CEPI shall have the right to take all such action as it shall consider necessary or appropriate at its discretion and expense to bring or defend an action on behalf of the Partner in relation to Project Vaccine for use in the Field and use of the Platform in the Field. The Partner shall (at CEPI’s cost) provide all reasonable assistance to CEPI as CEPI may request in relation to such action, including granting CEPI the right to bring an action in the name of the Partner (if necessary).
12.5 Release of Technology Transfer Materials. On the exercise of the Public Health License, the Partner shall release immediately the Technology Transfer Materials.
12.6 Contracts. Subject to applicable confidentiality obligations, the Partner shall provide CEPI with copies of all Sub-Contracts which relate to the Development of the Platform for use in the Field, the Development of Project Vaccine, and the Manufacturing of Product in the Field and access to which is required for the Third Party Manufacture within [*****] of exercise of the Public Health License. Provided that exercise of the Public Health License was not caused directly or indirectly by the Sub-Contractor and that Sub-Contractor is not then in breach, the Partner shall use all Reasonable Efforts, at CEPI’s reasonable request, to facilitate the conclusion of a direct contractual relationship between the Sub-Contractor and CEPI or Trusted Manufacturer to the extent required for CEPI or its nominee.
12.7 Clinical trials after exercise of Public Health License. Where CEPI has exercised the Public Health License and a clinical trial of Project Vaccines/ Products for use in the Field is to be conducted, CEPI shall:
12.7.1. ensure that the clinical trial has an appropriate Sponsor;
12.7.2. comply with CEPI’s insurance obligations pursuant to Clause 18.10 and ensure appropriate clinical trial liability insurance cover for the clinical trial is in place;
12.7.3. ensure that the clinical trial is conducted in accordance with GCP;
12.7.4. ensure that all Regulatory Approvals (including ethical committee approvals) necessary or reasonably useful for the conduct of the clinical trial are obtained;
12.7.5. ensure that a trial steering committee (TSC) is established which shall approve the clinical trial protocol and monitor the progress of the clinical trial, including any changes to the protocol. The TSC shall only include members who are independent of CEPI and who are not otherwise involved in the clinical trial;
12.7.6. communicate to Partner in writing immediately the occurrence of any Safety Issues; and
12.7.7. ensure that, to the extent possible, prior to enrolment and in accordance with all applicable laws and regulations, and as a condition of that clinical trial subject’s participation in the clinical trial, each subject provides his or her informed consent -to the extent legally permitted – to:
(i) direct access to his or her medical records;
(ii) process Data relating to him or her and to the movement of that Data to other countries, including countries outside of the European Economic Area;
(iii) transfer of such Data to the Partner, CEPI and/or Trusted Manufacturer(s) and the use of such Data in obtaining marketing approval and/or Platform Confirmation; and
(iv) use of samples in accordance with Clause 9.3.
13. Commercial Benefits Arising from Commercial Use
13.3 Use of Product in Affected Territory Only. CEPI intends to take Reasonable Efforts to ensure that the Products will be utilized in the Affected Territory only and to prevent parallel imports of such Products into other countries, which efforts may include CEPI or its contractor or licensee placing an indication on the packaging of the Products that they are for use in countries of the Affected Territory only and are not to be exported into any other countries. If either Party becomes aware that parallel imports of such Products outside the Affected Territory are occurring, the Parties will inform each other and will cooperate in good faith to verify the circumstances and take such reasonable action as they mutually agree is necessary.