Commercialization of Licensed Products. Licensee shall have sole authority and responsibility for, and shall use Commercially Reasonable Efforts in, the commercialization of Licensed Products in the Field, subject to Company’s Co-Promotion Right. Licensee shall have sole discretion with respect to the pricing of the Licensed Products in the Territory sold by Licensee, its Affiliates, its permitted Sublicensees or Company.
Commercialization of Licensed Products. With respect to each Licensed Product developed and commercialized by SPL, or its designated Affiliates, under this Agreement, SPL shall be solely responsible, at its sole expense, for all aspects of the development and commercialization of the Licensed Product in the Territory, including, without limitation:
(i) the manufacture of Designated Compounds and Licensed Products in accordance with the applicable Regulatory Approvals, laws, Good Laboratory Practices and Good Manufacturing Practices;
(ii) preparation, filing, obtaining, maintaining and supporting, in its own name or that of its designated Affiliate, with the appropriate regulatory authorities of all regulatory approvals, authorizations, permits and licenses (including, without limitation, all Regulatory Approvals) that are necessary to conduct clinical studies of Licensed Products and/or to manufacture, import, distribute, market and sell Licensed Products; *= CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
(iii) the reporting all adverse events associated with any Licensed Product to the appropriate regulatory authorities in accordance with applicable laws, rules and regulations in the Territory; and
(iv) the distribution, marketing, promotion and sale of Licensed Products. Following the expiration of the Screening Program, SPL shall provide NeoGenesis with semi-annual reports summarizing the status of SPL's development and commercialization activities with respect to each Licensed Product being developed under this Agreement. In addition, SPL shall notify NeoGenesis in writing upon the filing of each application for Regulatory Approval of a Licensed Product in the Territory.
Commercialization of Licensed Products. Commencing at the Closing, Otsuka shall have the exclusive right, and shall use Commercially Reasonable Efforts, to commercialize one or more Licensed Products in the Territory, which have been the subject of Full Regulatory Approval in relation to each Licensed Product for each indication, *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
Commercialization of Licensed Products. Subject to Sections 6.2 and 6.3 below, ZAI shall have the sole right to and responsibility for the Commercialization of Licensed Products in the Partner Territory, including manufacturing, selling, distributing and invoicing Licensed Products and would book one hundred percent (100%) of the sales, in the Partner Territory. ZAI shall conduct its Commercialization activities with respect to the Licensed Product in accordance with Applicable Law.
Commercialization of Licensed Products. 7.1. Teva undertakes, at its own expense, to make such commercially reasonable efforts to commercialize the Licensed Products as are consistent with the commercial efforts generally applied to products of similar potential at similar stages in their life cycles, by Teva.
7.2. Teva shall provide Protalix with a non-binding sales forecast for each of the Major Countries, in writing, in respect of each Licensed Product, by no later than [***] prior to the anticipated date of the first regulatory approval in respect thereto. Such report shall be updated by Teva, in writing, on a [***] basis. Moreover, each sales forecast shall be accompanied by a report of Teva’s and its Affiliates launch dates and main regulatory filings on a [***] basis with respect to the Licensed Products. Teva shall also provide Protalix with similar information with regard to such launch dates and filings in territories in which Sublicensees and Further Sublicensees have conducted similar activities, to the extent available to Teva.
7.3. For the removal of doubt, nothing contained in this Agreement shall be construed as a warranty by Teva that any efforts to be exerted by Teva in connection with this Agreement, including without limitation any development or any commercialization to be carried out by it in connection with this Agreement, will actually achieve their aims or any other results or succeed, and Teva makes no warranties whatsoever as to any results to be achieved in consequence of the carrying out of any such development, commercialization, efforts or activities. Furthermore, Teva makes no representation to the effect that the commercialization of the Licensed Products, or any part thereof, will succeed, or that it shall be able to sell the Licensed Products in any quantity.
Commercialization of Licensed Products. GSK shall have the right and be responsible at its expense for commercializing the Licensed Products for applications in the Field throughout the GSK Territory, subject to the limitations in Section
2.1.1. GSK agrees to use Commercially Reasonable Efforts to (a) seek and obtain Marketing Authorizations necessary to launch Licensed Products for applications in the Field in the GSK Territory, (b) after receipt of such Marketing Authorizations to launch Licensed Products for applications in the Field in the GSK Territory, and thereafter (c) to market, promote and sell such Licensed Products for application in the Field in the GSK Territory. In the event that GSK elects, in its sole discretion, not to launch and commercialize Licensed Products for applications in the Field in any country in the XXX Xxxxxxxxx, XXX shall promptly notify Santarus in writing of such decision, in which case Santarus shall have the right to terminate this Agreement with respect to such country in accordance with Section 13.3. For clarity, nothing in the previous sentence shall be construed to prejudice GSK’s right to terminate this Agreement pursuant to Section 13.4.2.
Commercialization of Licensed Products. As between BMS and Exscientia, BMS shall have the sole right and responsibility for the Commercialization of Licensed Products in the Field in the Territory at its cost and expense. BMS by itself and/or through its Affiliates and Sublicensees will use Diligent Efforts to Commercialize each Licensed Product in each of the Major Markets in which Regulatory Approval has been obtained for such Licensed Product and where pricing and reimbursement approval satisfactory to BMS or, as applicable, an Affiliate or Sublicensee of BMS, is obtained.
Commercialization of Licensed Products. As of and following the effective date of termination, as between the Parties and without limiting any other provision of this Agreement, Acceleron shall be solely responsible for all Commercialization of Licensed Products in the Field (including booking all sales, and managing the sale, invoicing and distribution system for Licensed Products in the Field), such Commercialization to be conducted in Acceleron’s sole discretion.
Commercialization of Licensed Products. Following receipt of Regulatory Approval for a Licensed Product in a given country in the Territory, Licensee will use Commercially Reasonable Efforts to Commercialize (and Manufacture for Commercialization) such Licensed Product in such country.
Commercialization of Licensed Products. GSK shall have the right and be responsible at its expense for commercializing the Licensed Products for applications in the Field throughout the GSK Territory, subject to the limitations in Section 2.1.1. GSK agrees to use Commercially Reasonable Efforts to (a) seek and obtain Marketing Authorizations necessary to *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. launch Licensed Products for applications in the Field in the GSK Territory, (b) after receipt of such Marketing Authorizations to launch Licensed Products for applications in the Field in the GSK Territory, and thereafter (c) to market, promote and sell such Licensed Products for application in the Field in the GSK Territory. In the event that GSK elects, in its sole discretion, not to launch and commercialize Licensed Products for applications in the Field in any country in the GXX Xxxxxxxxx, XXX shall promptly notify Santarus in writing of such decision, in which case Santarus shall have the right to terminate this Agreement with respect to such country in accordance with Section 13.3. For clarity, nothing in the previous sentence shall be construed to prejudice GSK’s right to terminate this Agreement pursuant to Section 13.4.2.
