Provision Language
Definitions
“Territory” means those countries defined from time to time by the World Bank as having “low-income economies” (or a mutually acceptable equivalent list of countries, if such World Bank lists are discontinued) together with additional countries as agreed between the Parties, as listed in Schedule 5, provided, however, that if countries that are not listed on Schedule 5 are subsequently defined as having “low-income economies”, the inclusion of such additional countries in the Territory shall be subject to the mutual agreement of Indevus and MRC. The term “Territory” shall permanently include those countries in Africa in which any of the clinical Centres participating in the Programme are situated, regardless of those countries’ status on the World Bank list referred to above;
(A) General
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9. Indevus agrees to take such steps as it considers in good faith to be commercially practicable and reasonable to assist in ensuring that the Product can become available to all communities who have a need for the Product, including developing countries’ markets as well as major commercial markets, subject to the following:
(a) In the case of countries in the Territory, Indevus agrees that:
(i) the Product and/or Indevus’ Intellectual Property Rights will be made available under licence to DFID and/or the MRC or their appointed agents solely for distribution and use of the Product in the Field in any countries in the Territory as set forth in the following sentence and in a separate supply agreement to be negotiated in good faith between Indevus and the MRC. The supply agreement will provide that the Product will be made available to DFID and/or the MRC or their appointed agents free on board at Indevus’ (or its designee’s) manufacturing facility, in exchange for which the MRC or the DFID will pay Indevus an amount equal to Indevus’ total cost of goods sold plus [*] %, and will include other terms relating to such supply, including terms relating to forecasts, orders, delivery and payments, to be mutually agreed to in good faith.
In the event that Indevus is unable or unwilling to supply sufficient Product to satisfy demand within any country in the Territory, Indevus will, at the request of DFID or the MRC, licence DFID or the MRC or their appointed agents, which may be an aid agency or other appropriate party (the“Proposed Licensee”) under Indevus’ Intellectual Property Rights the right to manufacture the Product in any country solely for distribution and use of the Product in the Field in the Territory. The terms and conditions of this license will be set forth in a license agreement to be negotiated in good faith between Indevus and the Proposed Licensee, which will include compensation to Indevus in consideration of the grant of such license. In negotiating these terms and conditions, Indevus and the Proposed Licensee will take into account and consider the importance of making the Product available at preferential prices in the Territory as well as a fair return to Indevus.
(b) Indevus’ obligations under this Agreement are in all cases subject to receipt of all regulatory authorizations and approvals required in any of the applicable countries to manufacture, use, sell and/or import Product, as required, and are expressly conditioned upon the absence of any adverse condition or event relating to the safety or efficacy of Product, including the absence of any action by any regulatory authority preventing or limiting the development, manufacturing or commercialization of Product.
(B) Subcontracting or transfer of rights and obligations
11. Indevus shall not assign this Agreement without the advance written agreement of the MRC’s authorised representative, such agreement not to be unreasonably withheld or delayed, provided however, that Indevus may assign this Agreement to an Affiliate or in connection with the transfer or sale of its business or all or substantially all of its assets or in the event of a merger, consolidation, change in control or similar corporate transaction, without such consent (“the Proviso”). In the event of a proposed assignment of this Agreement in circumstances other than covered under the Proviso above, the assignee shall assume Indevus’s obligations under this Agreement and, provided that such assignee does so, the MRC shall not withhold consent to the assignment.