OBLIGATIONS OF INDEVUS UNDER THIS AGREEMENT
5. Indevus shall supply sufficient quantities of the Product and matching placebo required for all the Centres participating in the Phase III Clinical Trial for the duration of the Programme at no cost for the supply of Product or placebo or their shipment to the main storage facility, as specified in the Protocol and any written Protocol amendments submitted as amendments to the IND, up to a maximum number of [*] doses of the Product at each strength and [*] doses of matching placebo (unless both parties’ authorised representatives agree in writing that Indevus shall supply an increased number of doses of Product and/or matching placebo). MRC and Indevus shall be jointly responsible for storing the Product and matching placebo at the main storage facility and distributing the Product and matching placebo to the Centres in accordance with the Protocol and any mutually agreed Protocol amendments submitted as an amendment to the IND with the related responsibilities and obligations of the parties to be set forth in a separate agreement among Indevus and MRC and the main storage facility. The Product and matching placebo shall be shipped in the quantities and at the intervals agreed to by both parties in good faith as quickly as reasonably practicable following receipt by Indevus of all documentation necessary to assure compliance with all applicable laws and regulations. Indevus may refrain from shipment of the Product and matching placebo to the storage facility or to one or more of the Centres if prohibited from doing so by any relevant regulatory authority. Indevus shall ship the Product and matching placebo only to Investigators participating in the Phase III Clinical Trial as referenced in 21 CFR 312.50, and may at its discretion discontinue shipments to Investigators who fail to comply with applicable regulations.
6. Indevus shall supply the Investigators’ brochures to the Centres at no cost.
7. If requested by the CTU or by any of the Centres, Indevus shall supply guidance on handling and storage of the Product and matching placebo.
8. When the Programme is completed or is terminated prior to completion the Centres shall arrange either (at Indevus’s election) for the destruction (without cost to Indevus) or return to Indevus (at Indevus’s cost) of any unused Product and matching placebo in accordance with the Protocol and all applicable legal requirements and the requirements of any relevant regulatory authorities.
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.