Master Alliance Provisions Guide (MAPGuide)

Funder Development Partnering Agreement

  • Liability | Insurance

Definitions

GHSI” means the Global Health Security Initiative, an informal, international partnership among like–minded countries to strengthen health preparedness and response globally to threats of biological, chemical, radio–nuclear terrorism (CBRN) and pandemic influenza.

14. Warranties and Liability

[…]

14.8 Insurance. The Partner will obtain and continuously maintain the following insurance on a claims arising basis with an insurance company of a credit rating of A or better:

14.8.1. During the period covered by the Development Plan, Clinical Trials Insurance as follows:

i. if the Clinical Trial is part of a biomedical countermeasure as defined by GHSI (in accordance with the recommendation from the GHSI dated [insert date]), (i) the recipient countries of the Product will be liable for any and all personal injury claims arising from the dosing of human subjects with the Product in the Clinical Trial and will provide compensation mechanisms to those of their citizens and residents receiving the Product as part of the Clinical Trial and (ii) the Partner will obtain and maintain Clinical Trial Cover on a claims arising basis of at least [x million GBP] per claim including non–negligence cover in accordance with the conditions of the Associated British Pharmaceutical Industry agreed wording for any other recipient of the Product as part of the Clinical Trial; and

ii. if the Clinical Trial is not part of a biomedical countermeasure as defined by GHSI, prior to the commencement of the Clinical Trial, the Partner shall obtain and maintain Clinical Trial Cover on a claims arising basis of at least [x million GBP] per claim including non–negligence cover in accordance with the conditions of the Associated British Pharmaceutical Industry agreed wording. Such Clinical Trial Cover to be effective from the commencement date of the Clinical Trial until at least six (6) years after the completion of the Clinical Trial or such longer period as is required by the relevant Ethical Committee.

14.8.2. From the date of the first Marketing Approval or if earlier, first sale to a Public Sector Agency, product liability insurance of at least [GBP y] per occurrence other than in Low Income Countries or Middle Income Countries covered by the WHO product liability insurance; and

14.8.3. During the term of this Agreement and for at least three (3) years afterwards, general commercial liability insurance including contractual liability of at least [GBP z] per occurrence.

14.9. The Partner shall:

14.9.1. Procure that the insurer notes FUNDER’s interest on each such insurance policy;

14.9.2. Provide FUNDER with a copy of each such insurance policy and certificate and annually on renewal;

14.9.3. Notify FUNDER of any claims made under these policies relating to the Product or the subject matter of this agreement during the Term and for at least the duration of any applicable statutory period of limitation afterwards; and

14.9.4. Comply with the terms of these insurance policies during the Term and for at least the duration of any applicable statutory period of limitation afterwards.