Final Manufacturing definition
Examples of Final Manufacturing in a sentence
Subject to Section 10.2.1, with effect from the Effective Date, ARIAD SWISSCO shall be responsible for the Final Manufacturing of all Product, including performing secondary packaging, labeling and providing product inserts and final release and stability testing in accordance with the Marketing Authorization and Regulatory Requirements in the country in the Territory that is the intended market for such lot of Product, and in accordance with all Applicable Laws.
Further, the Development, Final Manufacturing or Commercialization of Viela Compound or the Products in the manner reasonably contemplated under this Agreement or the Development Plans does not infringe and would not infringe any Patents listed in Exhibit E.
Except as set forth in Section 10.2, Otsuka shall be responsible for the Final Manufacturing of all Product, including performing primary and secondary packaging, labeling and providing product inserts in accordance with the Registrations, final release and stability testing in accordance with the Regulatory Authorization in the country in the Territory that is the intended market for such lot of Product, and in accordance with all Applicable Laws.
Viela retains all rights to Develop and Commercialize the Viela Compound and Products outside the Territory and all rights to Manufacture the Product, other than the right of Final Manufacturing of the Product in the Territory.
With respect to any Third Party License that is necessary or useful for Otsuka to perform Final Manufacturing of Product in the Territory and is not necessary for such Final Manufacturing to conform to any specifications provided by ARIAD under this Agreement, [***] shall have the final decision-making authority and responsibility for negotiating such Third Party License and for making any payments due thereunder, at its sole cost and expense.
In addition, within [***] ([***]) days after the Effective Date, the Parties or their Affiliates shall enter into one or more supply agreement(s) setting forth the Parties’ respective obligations regarding the Manufacture and supply of Bulk Product for use in the Final Manufacturing of Product for clinical trials and for commercial sale and promotional sampling.
Other than agreements with (i) its Sublicensees, (ii) customers which MTPC or its Affiliate or Sublicensee entered into in the normal course of business of selling the Product, (iii) Third Party contract manufacturers for the Final Manufacturing in the Territory, or (iv) contracted medical representatives, MTPC shall not enter into any agreement with Third Parties with respect to MTPC’s pharmacovigilance or quality assurance obligations relating to the Product.
As soon as practicable after the Effective Date, the Parties, through a project team or subcommittee of the JDCC, shall discuss the timeline and activities required to commence the Final Manufacturing in the Territory.
Employees who work less than 12 months shall have the option of receiving twelve (12) equal pay checks.
At a reasonable time prior to Otsuka’s initial purchase of Bulk Product for use in Final Manufacturing for commercial requirements for the Territory, and thereafter prior to [***] during the Term (or [***] in the event of a Price Cut as provided in Section 19.5.3), the Parties shall [***] (the “[***] Price”) at which ARIAD shall invoice Otsuka [***] of Product (both Bulk Product and Secondary Packaged Product) for such commercial requirements for the Territory.