Master Alliance Provisions Guide (MAPGuide)

CEPI – VBI, COVID-19 Vaccine Development Funding Agreement

  • Term & termination | Effects of termination
  • Term & termination | Termination & withdrawal

Definitions

Enabling Rights” means rights to Background Intellectual PropertyProject Intellectual Property and Project Results that could be asserted by Awardee or a Subawardee to block CEPI from exercising the Public Health Licence to make, have made, use, have used, import, sell or otherwise exploit the Project Vaccine. For purposes of this Agreement, Enabling Rights also includes the contractual rights that control the use of such items as, for example, rights to use biological materials covered in material transfer agreements entered into between Awardee and third parties.

Project Data” – pre-clinical and clinical trial data (including any negative results, model animal Project Vaccine-related deaths and any toxicology study issues) produced under the Project [defined under Section 9.1].

Project Materials” – biological samples, Project Vaccines, and other tangible materials produced under the Project [defined under Section 9.2].

Project Results” means all of the tangible materials and other results that are made or developed by or on behalf of Awardee and/or any Subawardee under the Project, including the Project Vaccine and assays developed by or on behalf of the Awardee or any Subawardee that are necessary for Project Vaccine production, whether in whole or in components, serum samples collected, protocols used in clinical or non-clinical evaluation of the Project Vaccine, Project Data, and Project Materials.

20. Term and Termination.

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20.2 Termination by Either Party for Default or Insolvency. Either Party (the “Terminating Party”) may terminate this Agreement by giving written notice of termination, effective immediately, if the other Party (the “Defaulting Party”):

(a) breaches a material obligation in this Agreement and either fails to cure that breach within a cure period of thirty (30) Business Days after notice from the Terminating Party or such longer time if agreed in writing or, if the breach is not reasonably capable of cure within thirty (30) Business Days, fails to take prompt and reasonable steps to cure the breach and maintain such diligent efforts until cure is achieved; or

(b) makes any statutory arrangement with its creditors, resolves to or undergoes any insolvency proceeding anywhere in the world (except for the purpose of solvent amalgamation or reconstruction).

20.3 Other Termination by CEPI. CEPI shall be entitled, in its sole discretion, to terminate this Agreement by providing written notice of termination to Awardee in the following circumstances:

(a) with immediate effect if CEPI notifies Awardee that there are material safety, regulatory, scientific misconduct or ethical issues associated with continuing the Project, as reasonably determined by CEPI and, if such issue is capable of remedy, Awardee has failed to remedy such issue within ten (10) Business Days;

(b) upon thirty (30) Business Days’ prior notice in writing, if CEPI determines that theProject must be materially limited in scope or terminated;

(c) CEPI reasonably determines that Awardee is unable to discharge its obligations under this Agreement, for example if key personnel or technology resources required for successful completion of the Project become unavailable to Awardee permanently or for a material period of time, and Awardee does not reasonably alleviate CEPI’s concerns within a cure period of thirty (30) Business Days or such longer time as may be agreed by the Parties in writing;

(d) Awardee does not satisfy the criteria in Clause 3.4 required for CEPI to pay funding tranches under a Work Package and fails to satisfy those criteria in full within a cure period of forty (40) Business Days or such longer time as may be agreed by the Parties in writing; or

(e) Awardee has committed fraud or a Financial Irregularity. For purposes of this Agreement, “Financial Irregularity” includes any and all kinds of corruption, including bribery, nepotism and illegal gratuities; misappropriation of cash, inventory and all other kinds of assets; and making fraudulent financial and non-financial statements to CEPI.

20.4 Payments After Certain Terminations by Awardee. If this Agreement is terminated by Awardee pursuant to Clause 20.2(a) – (b) (default or insolvency on the part of CEPI) or terminated by CEPI pursuant to Clause 20.3(a) – (b) (issues precluding continuation of the Project or limiting of Project Scope by CEPI), then CEPI shall reimburse Awardee for all reasonably incurred expenses through termination and any non-cancellable expenses relating to Project activities that were included in the iPDP and/or authorised in writing by CEPI and including those that arise through termination and after the termination date, solely to the extent they are not otherwise covered by CEPI funding and provided always that Awardee uses all reasonable endeavours to minimise and mitigate any such expenses.

20.5 Effects of Termination by CEPI under Clause 20.2(a) – (b) or 20.3(c) – (d). If this Agreement is terminated by CEPI pursuant to Clause 20.2(a) – (b) (default or insolvency on the part of Awardee) or 20.3(c) – (d) (inability to proceed or financial issues with Awardee), then CEPI shall reimburse Awardee for all expenses reasonably incurred prior to termination and any non-cancellable expenses relating to the Project activities that were included in the iPDP and/or authorised in writing by CEPI and that arise either before or after the date of termination, provided always that Awardee uses all reasonable endeavours to minimise and mitigate any such expenses. Additionally, Awardee shall use all reasonable endeavours to, and only to the extent required to practice CEPI Public Health License, at CEPI’s expense:

(a) make all Project Data publicly available in such manner as CEPI may direct, except to the extent that to do so would result in the public disclosure of Enabling Rights or Awardee Confidential Information or Confidential Information of a third party that would not otherwise reasonably be publicly disclosed;

(b) at CEPI’s sole discretion, either authorize access to or dispatch to CEPI (or its designee) by registered post or reputable courier services all Project Materials within twenty (20) Business Days of CEPI requesting such Project Materials in writing;

(c) grant rights to CEPI (or its designee) to any regulatory approvals and applications for regulatory approvals relating to the Project Vaccine;

(d) within twenty (20) Business Days of the date of termination, provide CEPI with an up-to-date list of all sublicence, contract manufacturing agreements and other third party agreements and arrangements to which Awardee is a party that solely relate to the development of the Project Vaccine and have deliverables or work outstanding as at the date of termination (the “Contracts”);

(e) as requested by CEPI, and to the extent it has the legal right to do so (i) assign the benefit (subject to the assumption of the burden) of one or more Contracts to CEPI (or its designee) and, where consent of a third party is required, seek to obtain such consent; (ii) novate one or more Contracts to CEPI (or its designee); or (iii) terminate one or more Contracts in accordance with its terms at Awardee’s cost;

(f) as requested by CEPI, perform technology transfer, on an expedited basis, to a Trusted Collaborator or Trusted Manufacturer, as the case may be; and

(g) as requested by CEPI, provide written confirmation or ratification in the event that CEPI exercises the Public Health Licence.

20.6 Additional Effects of Termination. Irrespective of the grounds for CEPI’s termination of the Agreement:

(a) CEPI shall not be required to make any further payments to Awardee under this Agreement or any Work Package other than as specified in this Clause 20;

(b) Awardee shall return any CEPI funds within twenty (20) Business Days from the date of termination that are unspent, if any, after deducting reimbursement to Awardee for all reasonably incurred expenses incurred prior to the termination date and any non-cancellable expenses relating to the Project activities that were included in the iPDP and/or authorised in writing by CEPI and that arise before or after the date of termination, provided always that Awardee uses all reasonable endeavours to minimise and mitigate any such expenses;

(c) each Party shall return or destroy, as requested by the other Party, the Confidential Information of the other Party, except that: (i) CEPI may retain the Project Results subject to the obligations of confidentiality set out in Clause 19, (ii) each Party may keep one (1) copy of such Confidential Information for monitoring compliance, and (iii) solely in the event that the Public Health Licence has been exercised, CEPI may retain such other Confidential Information reasonably required by CEPI to exercise and benefit from the Public Health Licence. Neither Party shall be required to delete copies of Confidential Information stored on automatic electronic backup systems;

(d) if there is an on-going clinical trial, unless agreed otherwise by the Parties in writing, Awardee shall ensure that no additional trial subjects are enrolled and the Parties shall work together to plan and implement a wind-down of the study in an orderly fashion, with due regard for patient safety and the rights of any participating subjects.

20.7 Repayment of Funds for Financial Irregularity. Where termination is due to any Financial Irregularity or fraudulent or illegal activity by Awardee, Awardee shall repay to CEPI the amount of funds related to such Financial Irregularity or fraudulent or illegal activity within twenty (20) Business Days of the notice of termination.

20.8 Survival of Rights and Identified Clauses. Termination of this Agreement shall be without prejudice to the rights and duties of either Party accrued prior to termination or expiry of the Agreement. The following sections shall continue to be enforceable notwithstanding termination or expiry: Clauses 3.8-3.11, 5.1-5.3, 6.7, 6.9(b), 9, 11.2 (solely to the extent applicable to any surviving obligations under this Agreement), 11.3, 11.4, 13.4, 13.5, 13.6, 13.7, 14.2, 15.1, 15.3, 15.4, 15.5, 15.6, 15.7, 15.8, 15.9, 15.10, 15.11, 15.12, 15.14, 16, 17.3, 18, 19, 20, 21, 22.1, 22.2, 22.3, 22.4, 22.5, 22.7, 22.9, 22.10, 22.11, 22.12, 22.14, 22.16, 22.17 as well as any other provision, which by its nature, is intended to survive termination.