Transfer of Manufacturing. Purchaser shall use commercially reasonable efforts to obtain, as promptly as practical after the Closing Date, all approvals necessary from the Regulatory Authority to manufacture the Product and the Drug Substance independently from Novartis. The Purchaser shall assume its own manufacturing (or sourcing from a Third Party) of the Drug Substance and the Product, as the case may be, promptly upon receipt of such approvals but in no event later than three (3) years after the Closing Date.
Transfer of Manufacturing. After exercise of the License Option on a Pharmacological Profile-by-Pharmacological Profile basis, (a) Scholar Rock shall (and shall cause its Affiliates and agents to) transfer to JBI, at JBI’s cost and expense for external, out-of-pocket costs associated with such activities, all manufacturing related documents and related materials and related information Controlled by Scholar Rock that may be reasonably necessary or useful for JBI to Manufacture or have Manufactured Collaboration Molecules, Lead [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED Molecules and/or Licensed Product with such Pharmacological Profile; and (b) as may be reasonably requested by JBI, Scholar Rock shall also use Commercially Reasonable Efforts to transfer to JBI all rights Scholar Rock may have in any agreements with Third Parties related to Manufacturing of Collaboration Molecules, Lead Molecules and/or Licensed Product with such Pharmacological Profile, provided Scholar Rock has such right to transfer without any payment obligation to such Third Parties under such agreements or, if there is a payment obligation, JBI reimburses Scholar Rock for costs incurred under any such obligation.
Transfer of Manufacturing. ELAN reserves the right to cease manufacturing the DSDF in the event that the PROFITS fail to give it a margin of ******* ******* ***** on its FULL COST subject to giving CLIENT 6 months prior written notice. In such an event and if so requested by THE CLIENT, ELAN shall grant to THE CLIENT the exclusive rights to manufacture, or have manufactured by a third party designated by CLIENT and acceptable to ELAN, the DSDF for the TERRITORY. In return for such a right to manufacture the DSDF, THE CLIENT shall pay to ELAN ***** ******* ***** of its PROFITS, which shall then be calculated based on the equivalent FULL COSTS of THE CLIENT or its appointed third party manufacturer. In the event of such a transfer of manufacture, the parties shall agree on a reasonable period of time under which said transfer is to be made and ELAN shall continue to supply CLIENT with the PRODUCT until such transfer is fully effected so that CLIENT's supply of the PRODUCT shall be continuous and uninterrupted. * redacted pursuant to confidential treatment request.
Transfer of Manufacturing. Subject to Clause 5.1(b), Purchaser shall obtain promptly after the Closing Date, all approvals necessary from the Regulatory Authorities to manufacture the finished Product independently from Novartis. Purchaser shall assume its own manufacturing (or sourcing from a Third Party) of the finished Product in accordance with the terms of the Supply Agreement, on a country‑by‑country basis, and in no event later than [***] from the Closing Date with respect to all countries in the Territory; provided, that such [***] period, and the Phase 2 Period, with respect to each applicable country in the Territory, may be extended upon the mutual agreement of the Parties if so required in order to facilitate the Tech Transfer Plan (as defined in the Supply Agreement). In the event that the Purchaser has failed to assume its own manufacturing as described in this Clause 5.2 with the respective timeline, this shall not affect Novartis’ obligations under the Supply Agreement, including the term of the Supply Agreement and Novartis’ obligation to provide the Product and the Drug Substance pursuant to the Supply Agreement.
Transfer of Manufacturing. In the event sanofi-aventis experiences a material change in its operations, including but not limited to a discontinuation of operations at a Production Site, a shift in manufacturing operations for its own products at the Production Site which limits its capacity to manufacture products for other parties, or otherwise changes strategic direction, and such change in sanofi-aventis’ sole judgment will render it unable to provide services at a Production Site, then sanofi-aventis shall immediately notify Horizon and take all commercially reasonable measures necessary to either change the Production Site to another facility of one of its Affiliates with similar capabilities or subcontract the services, in each case at sanofi-aventis’ expense (including, without limitation, any expense relating to technology transfer, excess shipping costs and tariffs related to finished bulk product including transfer, installation and validation of any Horizon Equipment or sanofi-aventis Equipment to another facility); provided, however, that (a) sanofi-aventis shall not change a Production Site or otherwise subcontract the services without the prior written approval of Horizon as set forth in this Agreement, not to be unreasonably withheld, and (b) until such time as the Parties otherwise agree, sanofi-aventis shall continue to be responsible for performing all obligations set forth in this Agreement at the current Production Site(s) and at the current Product Prices. If no such alternative is available, and the Parties cannot come to an alternative arrangement in good faith negotiations and consultations (for a period not to exceed […***…] days from the notice), then either Party may terminate this agreement by sending a further notice of no less than […***…] days. During this notice period, Horizon shall be able to increase its forecast, subject to then-applicable capacity limits of Production Site(s), in order to build up an adequate inventory of Product to meet its demand pending a shift in regulatory approval to its alternative manufacturing site or order such additional required Products from a third party contract manufacturer. Sanofi-aventis shall provide all reasonable assistance at it’s expense to assist Horizon with obtaining regulatory authorizations resulting from a change in a Production Site or in transitioning manufacture of the Product to a Third Party, at sanofi-aventis’ expense (including, without limitation, any expense relating to technology transfer, ...
Transfer of Manufacturing. 6.4.1 Upon request of GSK [***] Wave will enable, support and assist with the transfer of relevant manufacturing methods, processes and analytical methods together with all other reasonably necessary information and knowledge utilized by or on behalf of Wave in its manufacturing or supply of GSK Collaboration Products for such GSK CP to GSK or its nominee to support the manufacturing and supply of GSK Collaboration Products for such GSK CP.
Transfer of Manufacturing. The Questcor Parties shall use commercially reasonable efforts after the Closing Date to obtain all approvals necessary from the Regulatory Authorities to manufacture the Product and the Drug Substance independently from Novartis. Without prejudice to any provisions of the Supply Agreement, Purchaser shall assume its own manufacturing (or sourcing from a Third Party) of the Drug Substance and the Drug Product upon the end of the Transition Period and in no event later than [***] ([***]) years from the Closing Date. The Purchaser will transfer the secondary packaging operations as soon as practicable upon transfer of the Marketing Authorization on a country by country basis.
Transfer of Manufacturing. (a) If, prior to the date NuVasive exercises its Call Option or Progentix exercises its Put Option or its Second Put Option, Progentix materially fails to supply the quantities of Products meeting the Specifications as ordered by NuVasive hereunder, then upon written request of NuVasive, Progentix shall cooperate with NuVasive and transfer to a manufacturer selected by NuVasive and acceptable to Progentix (such acceptance not to be unreasonably withheld, conditioned or delayed), all technology, know-how, trade secrets, manufacturing methods and documentation related thereto as reasonably necessary for the continued manufacture of the Products. Following any such transfer under this clause (a), the then-current Sales Percentage shall be increased by *** percent (***%).
Transfer of Manufacturing. The delivery terms in Section 5.7(b) shall apply to MERCK if MERCK supplies Commercial API to ARIAD pursuant to Sections 2.6 and 2.7 and the delivery terms in Section 5.7(a) shall apply to ARIAD if ARIAD supplies Marketed Product to MERCK pursuant to Sections 2.6 and 2.7.
Transfer of Manufacturing. KNOW-HOW...................................
