Provision Language
Definitions
“Project Data” means pre-clinical or clinical trial data generated by or on behalf of a Partner under any Work Package, including any such data with respect to negative results, model animal deaths and any toxicology study results. For clarity, Project Data shall not include any Chemistry, Manufacturing and Controls (“CMC”) or other manufacturing- related information or data.
“Project Materials” means biological samples or, if applicable, animal models that are controlled by a Partner and are generated by or on behalf of Partner under any Work Package.
“Project Results” means the Project Materials, Project Data and Technical Reports that are generated by or on behalf of a Partner and/or any Subawardee under the Project, including with respect to results of assays necessary for Project Clinical Trial Material manufacturing in support of such manufacturing by or on behalf of a Partner and/or any Subawardee under the Project, whether in whole or in components or serum samples collected. For clarity,Project Results does not include Project Clinical Trial Materials.
2. PROJECT ORGANISATION AND MANAGEMENT
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2.5 Technical Reports and Access to Project Results. Each Partner shall disclose to CEPI’s Project Lead at JMAG meetings the Project Data that such Partner has been responsible for generating under the Project, and details of progress made under the Work Package(s) for such Project, in a form (including level of abstraction) reasonably acceptable to CEPI and the applicable Partner and consistent with applicable laws and regulations. Each Partner shall provide written reports of progress made under the Work Package(s) for such Project using the template provided by CEPI and attached hereto as Annex K (“Technical Reports”) every [***] during the Term in which activities under such Project are occurring. In addition, each Partner shall make Project Data available to CEPI as designated in and required by the applicable Work Package or otherwise as may reasonably be requested by CEPI from time to time, in a form (including level of abstraction) reasonably acceptable to CEPI and the applicable Partner, and consistent with applicable laws and regulations. Technical Reports and such Project Data and Project Results disclosed or provided by a Partner under this Clause 2.5 shall be such Partner’s Confidential Information.
3. USE OF FUNDS; PROCUREMENT; PROJECT RECORDS
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3.11 Financial Reports. Each Partner shall provide reports of its expenditure under the Budget for the Project with supporting documentation and using a template provided by CEPI (“Financial Reports”). In addition to the completed Financial Report template (the financial summary, a narrative explanation of the expenses/variances, assets register, and payment request), each Partner will provide the following additional supporting documentation: (i) general ledger report of all direct cost transactions during the reporting period; (ii) labour report that lists time charged by individual staff for the reporting period; (iii) sub-award invoices paid during the reporting period; and (iv) invoices/receipts/timesheets as requested by CEPI following receipt of general ledger report and based on a random sampling methodology. In addition, Barinthus Bio shall provide a copy of the published quarterly financial statements of Barinthus Biotherapeutics plc and the published annual statutory financial statements of Barinthus Bio.
3.12 Frequency of Financial Reporting. Each Partner shall submit financial reports within [***] of the end of its quarterly reporting period.
3.13 Project Records. Each Partner shall keep accurate records of its Project activities and expenditure under each Work Package and retain them for a period of [***] from the date of expiry or termination of this Agreement.
3.14 Access to Financial Records. During the Term and for a period of [***] after expiration or termination of this Agreement, CEPI’s designee (which shall be an internationally recognised certified public accounting firm, not engaged on a contingent basis), and at CEPI’s reasonable cost, shall have on-site access to inspect each Partner’s financial records with respect to the funding provided by CEPI pursuant to this Agreement once annually upon at least [***] advance written notice. Such inspections shall be conducted during normal operating hours in a manner to minimise disruption to such Partner’s business. For clarity, access to such records also shall be provided to records related to Cost of Goods for the Project Vaccine, as described in Clause 14.4. CEPI’s designee carrying out such inspection shall treat all financial records and other information subject to review under this Clause 3.14 in accordance with the confidentiality provisions of Clause 18. CEPI shall cause such designee to enter into a reasonably acceptable confidentiality agreement with the relevant Partner obligating such firm to retain all such financial records and other information in confidence pursuant to such confidentiality agreement.
3.15 Project Financial Audits. During the Term and for a period of [***] after expiration or termination of this Agreement, if requested by CEPI, and at CEPI’s reasonable cost, once annually upon reasonable prior notice, each Partner agrees to an external audit firm appointed by CEPI, reasonably acceptable to such Partner, conducting an audit or agreed upon procedures with respect to the funding provided by CEPI pursuant to this Agreement in accordance with ISA800 and/or ISA805 and like standards and provide CEPI with an audit report. Such inspections shall be conducted during normal operating hours, on advance notice of at least [***] on dates and at such times as reasonably agreed by CEPI and the applicable Partner, in a reasonable manner and in a manner to minimise disruption to such Partner’s activities. The receiving Party shall treat all information subject to review under this Clause 3.15 in accordance with the confidentiality provisions of Clause 18. CEPI shall cause any auditor pursuant to this Clause 3.15 to enter into a reasonably acceptable confidentiality agreement with the relevant Partner obligating such firm to retain all such financial information in confidence pursuant to such confidentiality agreement.
6. MANUFACTURE
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6.5 Records and Reporting. Each Partner shall use all reasonable endeavours to ensure that all data in relation to the manufacture of the Project Vaccine is appropriately recorded and that all such records are kept up to date and maintained in accordance with applicable laws and regulations. Upon CEPI’s reasonable request, each Partner will allow CEPI or its representative to review the data such Partner holds or controls from time to time in respect of the progress of the development of the manufacturing process.
8. REGULATORY ACTIVITIES
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8.2 Meetings with Regulatory Authorities. Each Partner shall notify CEPI in writing of any material meetings with Regulatory Authorities with respect to the Project Vaccine, or any Project Clinical Trial or other clinical trial that utilises any Project Clinical Trial Materials at least [***] in advance of such meetings, or if a Partner itself receives less than [***] notice of such a meeting, as soon as practicable. At CEPI’s option, the Partners shall consult with CEPI or its designee regarding any material interactions between a Partner and Regulatory Authorities relating to the Project Vaccine, or any Project Clinical Trial or other clinical trial that utilises any Project Clinical Trial Materials. At CEPI’s reasonable request, a Partner shall request a meeting with Regulatory Authorities to address any significant unresolved issues with respect to any Project Clinical Trial or other clinical trial that utilises any Project Clinical Trial Materials.
10. DISSEMINATION OF PROJECT RESULTS; PUBLICATION
10.1 Dissemination of Project Data. CEPI encourages the timely publication and other dissemination of Project Results. The Partners shall make the Project Data available to specified third parties if and to the extent described in a Work Package, as agreed by the JMAG, or as otherwise may be agreed between the Parties, always in compliance with applicable data protection legislation.
10.2 Dissemination of Project Materials. The Partners shall make the Project Materials available to specified third parties if and to the extent described in a Work Package, as agreed by the Parties at the JMAG, or as otherwise may be agreed between the Parties, and in each case subject to each Partner’s biobank standard operating procedures and policies and where there is appropriate ethical approval and informed consent. Such Project Materials shall be made available solely to the extent the applicable laws permit, as reasonably required by CEPI to inform the public health response and help save lives, and to the extent reasonably available after the Partners, their Affiliates and their (sub)licensees with respect to such materials have completed all research or development activities involving the use of such materials and applied for any desired patent protection, provided that, the dissemination of the Project Materials shall be delayed by no more than [***] to secure any such patent protection. Notwithstanding the foregoing, (i) the Partners shall be notified in advance of the purpose of use of Project Materials and the identity of recipient third parties, and (ii) any results of such use shall be promptly disclosed to the Partners. Any publication of the Project Material shall be subject to Clauses 10.3 and 10.5.
11. INDEPENDENT ASSESSORS
11.1 Independent Assessors. During the Term, as required in a Work Package or as otherwise reasonably requested by CEPI, subject to Clause 11.2, each Partner shall cooperate with and provide reasonable assistance to consultants reasonably acceptable to such Partner (“Assessors”) (which may include but is not limited to the Task Force for Global Health and its Safety Platform for Emergency vACcines (SPEAC) Project), retained in confidence and at CEPI’s expense, to consult on development of clinical trial protocols, explore development strategies, and evaluate Project Data and review Project Results, including to use such Project Data to evaluate any Project Vaccine. Each Partner acknowledges that such Assessors may provide CEPI with directly comparable evaluations of similar materials developed under CEPI’s portfolio of awarded projects. The results of the analysis, meta-analysis or other assessments by such Assessor(s) shall be subject to the confidentiality obligations of this Agreement and all non-disclosure agreements or material transfer agreements entered into pursuant to Clause 11.2. CEPI shall promptly provide the Partners with access to the results of any evaluation by an Assessor solely to the extent such assessment directly relates to the Project Results or Project Vaccine. For clarity, CEPI shall not be required to grant access to any information regarding CEPI’s portfolio of other awarded projects and shall be entitled to redact such information to the extent it is not obliged to grant access to such information to the Partners in accordance with this Clause.
11.2 Conditions for Assessor(s) Access. Prior to any Partner or CEPI disclosing to any Assessor any Project Results or other relevant information or materials with respect to any Project Vaccine under the Work Package(s), such Partner and the Assessor(s) shall, at their own discretion, enter directly into an appropriate agreement between themselves to the extent necessary to facilitate any Assessor’s activities under Clause 11.1, such as a non-disclosure agreement or material transfer agreement, and pursuant to such agreement the Assessor(s) shall covenant to comply with the confidentiality terms thereof and use such Project Results and other relevant information or materials solely for the purpose(s) of the applicable assessment(s) and not for any other purpose. CEPI shall, through the JMAG or otherwise, discuss with the Partners protocols and data management related to any Assessor’s activities under Clause 11.1.
11.3 Partner Cooperation. The Partners shall provide reasonable assistance to CEPI and any designated Assessors to facilitate any Assessor’s activities under Clause 11.1 at such times and locations as are reasonably agreeable to by the applicable Partner and CEPI and, to the extent reasonably required for CEPI or the designated Assessor, to evaluate the progress of the funded activities, including:
11.3.1 ensuring that any samples to be transferred or exported by or on behalf of a Partner from a clinical trial site or sample storage site are transferred and/or exported pursuant to the terms and conditions of a material transfer agreement to be entered into between such Partner and the Assessor in a form reasonably acceptable to CEPI, the applicable Partner and the Assessor, in addition to any other applicable laws and regulations; and
11.3.2 cooperating with regard to any data analysis, to the extent relevant under a given Work Package and permitted under applicable laws, regulations, and study site policies, and as reasonably requested by CEPI by:
(i) providing appropriate data or other information generated under any Work Package to CEPI’s designated Assessor as CEPI may instruct, including data regarding the results of any of its pre-clinical or clinical trials under any Work Package (duly anonymised and, upon CEPI’s request, blinded), and other documents and information from activities under any Work Package such as study protocols, case report forms needed to develop standardised approaches and tools for safety data management;
(ii) considering in good faith whether to provide CEPI’s designated Assessor with other data not generated under any Work Package (duly anonymised and, upon CEPI’s or the applicable Partner’s request, blinded) as CEPI may reasonably request in order to conduct comparative assessments;
(iii) providing CEPI’s designated Assessor with clinical trial data generated under any Work Package (duly anonymised and, at CEPI’s request, blinded) for the purposes of signal detection or meta-analyses of safety data (including across product candidates); and
(iv) providing CEPI’s designated Assessor a reasonable opportunity to inspect appropriate CMC data generated by or on behalf of a Partner under any Work Package at the applicable facility(ies) designated by such Partner on reasonable notice during ordinary business hours.
Any disclosures by or on behalf of a Partner pursuant to this Clause 11.3 shall be made in the form maintained by or on behalf of such Partner and shall be subject to reasonable redactions to the extent reasonably necessary to protect such Partner’s trade secrets or other non-public financially sensitive information (including CMC data). Each Partner may require written obligations of confidentiality, non-disclosure and non-use between CEPI and its designated Assessor in accordance with Clause 18.3.5 , such obligations to include that Assessor will not disclose such information, without the applicable Partner’s prior written consent.
12. COMPLIANCE
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12.4 Compliance Audit. During the Term and for a period of [***] after expiration or termination of this Agreement, CEPI, or an auditor appointed by CEPI, shall be entitled not more than once annually to audit each Partner’s performance of its compliance obligations under thisAgreement, upon reasonable advance notice of at least [***]. Such audits will be conducted during normal operating hours, on a date and at such time as reasonably agreed by CEPI and the audited Partner, in a reasonable manner and in a manner so as to minimise disruption to such Partner’s business. Such audits may include requests for documentation concerning such Partner’s own costs as well as Subawardees’ costs in connection with the Project, and such Partner shall use all reasonable endeavours to provide such documentation to CEPI without undue delay. CEPI shall cause any auditor pursuant to this Clause 12.4 to enter into a reasonably acceptable confidentiality agreement with the audited Partner obligating such auditor to retain all such information in confidence pursuant to such confidentiality agreement.
12.5 Compliance by Sub-Contractors. Each Partner shall use all reasonable endeavours to ensure that any Sub-Contractors engaged for the Project conduct any activities pursuant to this Agreement in accordance with the compliance obligations in this Clause 12 in all material respects. If any Partner becomes aware that a Sub-Contractor does not comply with the compliance obligations in this Clause 12 in all material respects, such Partner shall promptly notify CEPI and the Parties will discuss in good faith whether such Sub- Contractor can be brought into compliance within a reasonable time or whether any other actions are necessary to achieve compliance.
14. EQUITABLE ACCESS.
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14.4 Information about Production, Supply, Pricing and Sales. Upon written request by CEPI, each Partner shall provide reasonable information about its COGs, production, supply, pricing and sales of the Project Vaccine, sufficient to enable CEPI to evaluate whether such activities are consistent with the Partners’ obligations under this Agreement.
15. COMMERCIAL BENEFITS
15.1 Barinthus Bio
15.1.4 Barinthus Bio shall promptly notify CEPI, in writing, of any Commercial Benefits arising from the Project Vaccine, including details of all Net Income, Net Sales and Net Revenue received, on which payments are due hereunder. Once the foregoing notification has been provided, Barinthus Bio shall, from then on, submit to CEPI within [***], a written report setting out the details of (i) the price at which Barinthus Bio and its Affiliates sell Project Vaccines in LMICs or UMICs, including COGs for such Project Vaccines (“Selling Price”), and (ii) all Net Income, Net Sales and Net Revenue received by Barinthus Bio [***] and the associated payment due to CEPI under Clause 15.1.1. CEPI will invoice Barinthus Bio for the payments due to CEPI under Clause 15.1.1 on the Net Income, Net Sales and Net Revenue reported by Barinthus Bio and Barinthus Bio will pay such amounts to CEPI within [***] following receipt of such invoice.
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15.1.7 Financial Records and Audits. Barinthus Bio shall keep, and shall require its Affiliates to keep, accurate records pertaining to all Net Income, Net Sales and Net Revenue received by Barinthus Bio and its Affiliates. If requested by CEPI, and at CEPI’s reasonable cost, once annually upon reasonable prior notice, Barinthus Bio agrees to an external audit firm appointed by CEPI, reasonably acceptable to Barinthus Bio, conducting an audit with respect to all amounts owed to CEPI pursuant to this Agreement, including in respect of the calculation of Net Income, Net Sales and Net Revenue and associated payments to CEPI, in accordance with ISA800 and/or ISA805 and like standards and provide CEPI with an audit report. Such inspections shall be conducted during normal operating hours, on advance notice of at least [***] on dates and at such times as reasonably agreed by CEPI and Barinthus Bio, in a reasonable manner and in a manner to minimise disruption to Barinthus Bio’s activities. The receiving Party shall treat all information subject to review under this Clause 15.1.7 in accordance with the confidentiality provisions of Clause 18. CEPI shall cause any auditor pursuant to this Clause 15.1.7 to enter into a reasonably acceptable confidentiality agreement with Barinthus Bio obligating such firm to retain all such financial information in confidence pursuant to such confidentiality agreement. CEPI shall disclose to Barinthus Bio the audit report, and, to the extent that it is in CEPI’s possession, any calculations and workings underlying it, and shall give Barinthus Bio an opportunity to discuss the report with CEPI and the audit firm. Absent manifest error or fraud, the audit report shall be binding on both Parties. Barinthus Bio promptly pay any shortfall to CEPI, and CEPI shall promptly repay any overpayment, and if the report finds an underpayment by 15.1.7 Financial Records and Audits . Barinthus Bio shall keep, and shall require its Affiliates to keep, accurate records pertaining to all Net Income, Net Sales and Net Revenue received by Barinthus Bio and its Affiliates. If requested by CEPI, and at CEPI’s reasonable cost, once annually upon reasonable prior notice, Barinthus Bio agrees to an external audit firm appointed by CEPI, reasonably acceptable to Barinthus Bio, conducting an audit with respect to all amounts owed to CEPI pursuant to this Agreement, including in respect of the calculation of Net Income, Net Sales and Net Revenue and associated payments to CEPI, in accordance with ISA800 and/or ISA805 and like standards and provide CEPI with an audit report. Such inspections shall be conducted during normal operating hours, on advance notice of at least [***] on dates and at such times as reasonably agreed by CEPI and Barinthus Bio, in a reasonable manner and in a manner to minimise disruption to Barinthus Bio’s activities. The receiving Party shall treat all information subject to review under this Clause 15.1.7 in accordance with the confidentiality provisions of Clause 18 . CEPI shall cause any auditor pursuant to this Clause 15.1.7 to enter into a reasonably acceptable confidentiality agreement with Barinthus Bio obligating such firm to retain all such financial information in confidence pursuant to such confidentiality agreement. CEPI shall disclose to Barinthus Bio the audit report, and, to the extent that it is in CEPI’s possession, any calculations and workings underlying it, and shall give Barinthus Bio an opportunity to discuss the report with CEPI and the audit firm. Absent manifest error or fraud, the audit report shall be binding on both Parties. Barinthus Bio promptly pay any shortfall to CEPI, and CEPI shall promptly repay any overpayment, and if the report finds an underpayment by Barinthus Bio of more than [***] Barinthus Bio shall pay the reasonable fees and expenses charged by the audit firm. Otherwise the costs of the audit firm shall be payable by CEPI. If either Party challenges the audit report on the basis of manifest error or fraud, the matter shall be dealt with under Clause 20 (Resolving Differences).
15.1.8 Selling Price and COGs Audit. Barinthus Bio shall keep, and shall require its Affiliates and manufacturers (as applicable) to keep, accurate records pertaining to the Selling Price and the calculation of COGs in respect of the Project Vaccine in order to demonstrate Barinthus Bio’s compliance with its obligations under Clause 14.5. If requested by CEPI, and at CEPI’s reasonable cost, Barinthus Bio shall provide to CEPI all such records and any supporting documentation reasonably requested by CEPI for review by CEPI or an external audit firm appointed by CEPI, reasonably acceptable to Barinthus Bio. If requested by CEPI or Barinthus Bio, Barinthus Bio and CEPI and any such audit firm shall meet to discuss the Selling Price and such calculation. Such review shall take place no more than once annually. CEPI shall treat all information subject to review under this Clause 15.1.8 in accordance with the confidentiality provisions of Clause 18. CEPI shall cause any audit firm receiving information pursuant to this Clause 15.1.8 to enter into a reasonably acceptable confidentiality agreement with Barinthus Bio obligating such firm to retain all such information in confidence pursuant to such confidentiality agreement. CEPI shall disclose to Barinthus Bio the results of any such review, and, to the extent it is in CEPI’s possession, any calculations and workings underlying those results, and shall give Barinthus Bio an opportunity to discuss the results of the review with CEPI and the audit firm. Absent manifest error or fraud, if the audit report concludes that there has been an error in the calculation of the Selling Price, this shall be binding on both Parties and [***]. For the avoidance of doubt, any remedies set out in this Clause 15.1.8 are in addition to all other remedies available to CEPI, whether under this Agreement, at law or in equity. If either Party challenges the audit report, on the basis of manifest error or fraud, the matter shall be dealt with under Clause 20 (Resolving Differences).
15.2 Oxford
15.2.1 Oxford will promptly notify CEPI of any Commercial Benefits it receives. Promptly after receipt of such notification, Oxford and CEPI shall enter into a revenue share agreement detailing the share of Commercial Benefits that will be allocated to CEPI.