Provision Language
Definitions
“Centres” means the clinical and non-clinical centres participating in the Programme as detailed in Schedule 4 to this Agreement, as amended from time to time by decision of the Programme Management Board or the Programme Liaison Group.
“Trial Data” means case record forms and related material (including copies of correspondence, hospital and clinic notes and discharge summaries, relevant information from telephone conversations and site visits) on individual participants received from the Centres and laboratory results obtained from the laboratories participating in the Phase III Clinical Trial. All such data will be anonymous.
(A) General
4. Indevus grants a non-exclusive, non-transferable licence to MRC of Indevus’ Intellectual Property Rights in the Product with the right to sub-license to the Centres, solely for the purpose of using the Product in the Phase III Clinical Trial of the Programme at the Centres in the Field pursuant to the Protocol.
(E) Confidentiality, publication of data and intellectual property rights
Access to and publication of data
35. The Trial Data shall be owned or Controlled by the MRC, subject to the license granted to Indevus in the following sentence. The MRC hereby grants to Indevus an exclusive, worldwide license, including the right to grant sublicenses, under the Trial Data, the Know-How and any other Intellectual Property owned or Controlled by the MRC that is developed, made or conceived by or on behalf of the MRC during the course of, in furtherance of, and as a result of activities performed pursuant to the Programme (the “Programme IP”), to develop, make, have made, use, offer for sale, sell, import, and distribute Product for any use. In consideration of the foregoing, Indevus shall pay MRC royalties in an amount equal to [*] of Net Sales by Indevus, its Affiliates or sublicensees outside the Territory in each year during the Royalty Term if the manufacture, use or sale of Product uses or embodies MRC’s Intellectual Property Rights and Indevus’s Intellectual Property Rights, provided however, that in the case of sales by a sublicensee of Indevus, royalties payable by Indevus to MRC in any year during the Royalty Term shall not exceed [*] of all revenues received by Indevus from such sublicensee during that year. […]
36. MRC acknowledges that pursuant to the foregoing license, Indevus may use the Trial Data or any part of it in the following ways:
(a) for research and development purposes;
(b) Indevus may disclose the Trial Data or any part of it to any third party with whom Indevus is considering entering into negotiations in respect of a licensing agreement or similar agreement and/or has entered into such an agreement, provided such disclosure is under a duty of confidentiality similar to the confidentiality obligations of Indevus under this Agreement;
(c) Indevus may disclose and submit the Trial Data or any part of it to any competent regulatory authority in order to discuss and/or apply for or in connection with any regulatory, marketing and/or other applications or approvals; and
(d) Indevus may use the Trial Data or any part of it in connection with the commercialization of Product, provided that such use be anonymous with respect to individual participants in the Phase III Clinical Trial.