Master Alliance Provisions Guide (MAPGuide)

CEPI – Novavax, COVID-19 Vaccine Funding Agreement

  • Term & termination | Effect of termination
  • Term & termination | Term of agreement
  • Term & termination | Termination & withdrawal

19. Term and Termination

19.1 Term. This Agreement shall commence on the Effective Date identified in the Agreement Summary and shall continue in full force and effect until the activities set out in all active Work Packages, including any additional Work Packages, have been completed or until the Agreement otherwise is terminated pursuant to this Clause 19 (the “Term”).

19.2 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 [***] after notice from the Terminating Party or longer time if agreed in writing or if prompt and reasonable steps to cure the breach are undertaken when the breach is not reasonably capable of cure with [***] and such diligent efforts are maintained until cure is achieved; or

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

19.3 Other Termination by CEPI. CEPI shall be entitled to terminate this Agreement by providing written notice of termination to Awardee in the following circumstances:

(a) with [***] if CEPI notifies Awardee that there are material safety, regulatory or ethical issues with continuing the Project, as reasonably determined by CEPI;

(b) subject to Clause 4.2 upon [***] prior written notice, if CEPI determines that the Project must be limited in scope or terminated;

(c) CEPI reasonably determines that Awardee is unable, or shall become unable, to discharge its obligations under this Agreement, [***] and Awardee does not reasonably alleviate CEPI’s concerns within a cure period of [***] or such longer time as may be agreed by the Parties in writing; or

(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 [***] or such longer time as may be agreed by the Parties in writing.

(e) Awardee has committed fraud or a Financial Irregularity. For purposes of this Agreement, “Financial Irregularity” refers to 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.

19.4 Payments After Certain Terminations by Awardee. If this Agreement is terminated by Awardee pursuant to Clause 19.2(a) – (b) (default or insolvency on the part of CEPI) or terminated by CEPI pursuant to Clause 19.3(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 [Integrated Product Development Plan] and/or authorised by CEPI and that arise through termination and after the termination date, solely to the extent they are not otherwise covered by CEPI funding.

19.5 Effects of Termination by CEPI under Clause 19.2(a) – (b) or 19.3 (c) – (e). If this Agreement is terminated by CEPI pursuant to Clause 19.2(a) – (b) (default or insolvency on the part of Awardee) or 19.3 (c) – (e) (inability to proceed or financial issues with Awardee), then, CEPI shall reimburse Awardee for all reasonably incurred expenses through termination and any non-cancellable expenses relating to the Project activities that were included in in the iPDP and/or authorised by CEPI and that arise through termination and after the termination date. Additionally, Awardee shall use all reasonable endeavours to, 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 that would not otherwise reasonably be publicly disclosed;

(b) ship to CEPI (or its designee) all Project Materials within [***] of CEPI requesting such Materials in writing;

(c) [***] transfer to CEPI (or its designee), any regulatory approvals and applications for regulatory approvals relating to the Project Vaccine;

(d) provide CEPI with an updated list of all sublicense, contract manufacturing agreements and other third party agreements and arrangement to which Awardee is a party that solely relate to the development of the Project Vaccine and still have work outstanding (the “Contracts”) within [***] of the Termination Date;

(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 [***];

(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 License.

19.6 Additional Effects of Termination. In all termination events:

(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 19;

(b) Awardee shall return any CEPI funds within [***] from the date of termination that are unspent, if any, after deducting reimbursement to Awardee for all reasonably incurred expenses through termination and any non-cancellable expenses relating to the Project activities that were included in the iPDP and/or authorised by CEPI and that arise through termination and after the termination date;

(c) each Party shall return or destroy, as requested by the other Party, the Confidential Information of the other Party, except: (i) CEPI may retain the Project Results subject to the obligations of confidentiality set out in Clause 18, (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 License has been exercised, CEPI may retain such other Confidential Information reasonably required by CEPI to exercise and benefit from the Public Health License. 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.

19.7 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 [***] of the notice of termination.