Master Alliance Provisions Guide (MAPGuide)

CEPI – Valneva, Chikungunya Vaccine Funding Agreement

  • Information & materials sharing | Technology transfer
  • Term & termination | Effect of termination

20. Term and Termination

20.4 Additional Awardee Termination Rights. […]

e. The following provisions shall apply in case of termination according to Clauses 20.4 a. to 20.4 d. above:

1. Awardee will collaborate with CEPI in good faith for [***] following receipt by CEPI of the termination notice from Awardee, to find a third party to which Awardee’s obligations under this Agreement with regard to Awardee’s Traveler’s Market and/or the Non-Traveler’s Market Countries (depending on which market is affected by the termination) will be assigned (a “Third Party Supplier”).

2. If within such [***] period such a Third Party Supplier is identified, Awardee shall:

a. transfer all of the technology and intellectual property (with the exception of trademarks) required by CEPI and the Third Party Supplier to manufacture both the drug substance and the drug product including all necessary guidance, information, materials and assistance reasonably required by CEPI and such Third Party Supplier. Any reasonable costs related to such transfer shall be borne by CEPI. Notwithstanding the foregoing, Awardee may decide in its sole discretion whether any Product-related trademark should be transferred to a Third Party Supplier.

b. grant the Public Health License to CEPI and to the Third Party Supplier or such other third party as CEPI may direct.

3. If the Parties are unable to identify a Third Party Supplier within the period of [***] following receipt by CEPI of the termination notice, Awardee’s obligations under this Agreement shall cease (except for any continuing obligations as provided for pursuant to Clause 20.6) and the performance of the obligations of each Party under this Agreement shall be suspended for an indefinite period of time. The Parties shall agree the reasonable steps to be taken to suspend the manufacture of the Products and any agreed costs incurred in connection with such suspension shall be borne by CEPI. Reactivating the suspended Agreement shall require both Parties written agreement.

4. In case of termination of this Agreement in accordance with this Clause 20.4, Awardee will supply to CEPI such quantities of drug substance and drug product as may be reasonably required by CEPI to create a stockpile of Product to meet its requirements for the Product until the technology transfer described in Clause 20.4 e 2 is complete. The delivery deadline of such safety stock shall be agreed by the Parties taking into consideration the volume request by CEPI and Awardee’s and its contract manufacturer’s capacities. CEPI shall pay for the the supply of such drug substance and drug product in accordance with the pricing provisions included in Clause 16.7 or as otherwise agreed by the Parties.

20.5 Effects of Termination. In all termination events:
a. CEPI will not be required to make any further payments to Awardee under this Agreement or any Work Package other than to reimburse Awardee for any non-cancellable expenses incurred in accordance with the Work Package in accordance with Schedule B;

b. Awardee will return any CEPI funds which are unspent at the date of termination within [***] of the date of termination;

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 22.4, (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 which embodies the Enabling Rights as may be 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 study funded by CEPI (whether in whole or in part), unless Awardee decides in its sole discretion to continue such clinical study at Awardee’s cost or unless agreed otherwise by the Parties in writing, Awardee will ensure that no additional trial subjects are enrolled and the Parties will 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; and e. the Parties will give effect to the relevant termination or expiration obligations described in Schedule B to these T&Cs.

Schedule B: Effects of Termination 

Obligations on Termination by Awardee Pursuant to Clause 20.2 (Termination for Default)

CEPI shall reimburse Awardee for all reasonably incurred non-cancellable expenses relating to the Project which were authorised by CEPI and which arise after the termination date, solely to the extent they are not otherwise covered by CEPI funding.

Obligations on Expiration or Termination Pursuant to Clause 20.3(b) (Termination due to Safety, Regulatory or Ethical Issues)

CEPI shall reimburse Awardee for all reasonably incurred non-cancellable expenses which were authorised by CEPI and which arise after the termination date, solely to the extent they are not otherwise covered by CEPI funding, and the Parties will work together to plan and implement a wind- down of the Work Package in an orderly fashion relating to the Project.

Obligations on Termination by CEPI Pursuant to Clauses 20.2, 20.3a) or 20.3c) (Termination For Default; CEPI’s Reasonable Determination that Awardee is or will be Unable to Perform; or Failure to Satisfy Clause 4.5, respectively)

Solely at CEPI’s discretion, CEPI may reimburse Awardee for some or all or Awardee’s reasonably incurred non-cancellable expenses relating to the Project which were authorised by CEPI and which arise after the termination date.

Subject to Clause 11.2, Awardee shall promptly make all Project Data publically available in such manner as CEPI may direct, save to the extent that to do so would result in the public disclosure of Enabling Technology which would not otherwise be publically disclosed.

CEPI shall have the right to require Awardee, at CEPI’s discretion, to either: (i) perform Technology Transfer to a Trusted Collaborator (including any Trusted Collaborator appointed pursuant to Clause 17.3) on an expedited basis at the Awardee’s cost, or (ii) if Technology Transfer has already occurred at the date of termination and certain costs in relation to such Technology Transfer were borne by CEPI, reimburse CEPI for such costs.

CEPI shall have the right to exercise the Public Health License, pursuant to Clause17.2.c).

Awardee shall use all reasonable endeavours to promptly transfer to CEPI (or its nominee), at Awardee’s cost, any regulatory approvals and applications for regulatory approvals relating to the Product.

Awardee shall ship to CEPI (or its nominee) all Project Materials within [***] of CEPI requesting such Materials.

Awardee shall provide CEPI with a list of all sub-license, contract manufacturing agreements and other agreements and arrangement to which Awardee is a party which relate to the development and marketing of the Product (the “Contracts”), within [***] of the Termination Date. CEPI may request copies of any Contracts, which Awardee will promptly provide.

CEPI shall have the right to require Awardee to: (i) assign the benefit (subject to the assumption of the burden) of one or more Contracts to CEPI or its nominee and, where consent of a third party is required, seek to obtain such consent; (ii) novate one or more Contracts to CEPI or its nominee; or (iii) terminate one or more Contracts in accordance with its terms at Awardee’s cost.

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. “Financial irregularity” refers to all kinds of: corruption, including bribery, nepotism and illegal gratuities; misappropriation of cash, inventory and all other kinds of assets; and financial and non-financial fraudulent statements.