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. 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. 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 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. 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. In the case where ROCHE assumes manufacturing for its supply requirements pursuant to Article V, Section 13 (i) of the License Agreement, ROCHE will reimburse GENENTECH for 100 % of the costs incurred by GENENTECH in making the transfer including overhead and for the cost of Idle Capacity as describe in the next section. COST OF IDLE CAPACITY --- The principle of cost of Idle Capacity shall only apply in the case of Article V, Section 13 (i) of the License Agreement and for a period of four (4) years from notification by ROCHE that it will assume manufacturing. The Cost of Idle Capacity (CIC) shall be determined and charged to ROCHE as follows:
Transfer of Manufacturing. (a) It is the intention of the Parties to jointly select a contract manufacturer for both Drug Substance and Product. The Parties agree to engage in a joint selection process with agreed selection criteria. Either Party shall be free to discontinue the selection process at any time at their own discretion and, in such case, the Parties are free to choose their own manufacturing solution. In such case, the Transition Services to be provided by Novartis for the transfer of manufacturing will be strictly limited to the services agreed to in the relevant subsections of Clause 6.1 and Novartis shall not be obligated to provide support for transfer of manufacturing beyond Clause 6.1.
(b) Irrespective of Clause 5.2(a), Purchaser or its Affiliates shall assume its own manufacturing (or sourcing from a third party) of the Drug Substance and the Product, immediately upon transfer of the Marketing Authorization on a country- by-country basis, and in no event later than three (3) years from the Closing Date.
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 (***%).
(b) If, after 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.
Transfer of Manufacturing. (a) At any time after the expiration of the last to expire Initial Royalty Term in any country in the Otsuka Territory, on twelve (12) months’ written notice to Otsuka, Aurinia may, at its expense, transfer to Otsuka the ability to Manufacture or acquire Products from a CMO on terms no less favorable to Otsuka in the aggregate than the terms of any Supply Agreement then in effect. Upon such transfer, (a) Aurinia shall have no further obligation for the supply of Product, (b) neither Party shall have any further obligations under Sections 2.4 (Access to Sublicensee Work Product), 2.6 (Negotiation Right), 2.7 (Disclosure of Know-How), 2.8 (Third Party IP Agreements) (only with respect to any Third Party IP identified after such transfer), 3.1 (Joint Collaboration Committees; Responsibilities), 3.2 (Executive Meeting), Article 4 (Development), Article 5 (Regulatory Activities), Article 6 (Commercialization and Medical Affairs), and Article 7 (Manufacture and Supply), in each case except to the extent any such Sections survive termination or expiration of this Agreement as provided in Section 14.8) and (c) the royalty payable to Aurinia hereunder pursuant to Section 8.4(d)(i) shall be reduced as set out therein.
Transfer of Manufacturing. KNOW-HOW...................................
4.1 Third-Party Manufacturer(s)...................................
4.2 Transfer of Manufacturing Know-How............................
