Manufacturing Activities. Shire will:
Manufacturing Activities. New River will:
Manufacturing Activities. The Product to be manufactured by or for Novartis for sale in the Territory shall be manufactured to meet all specifications for the Product in accordance with the NDA, cGMP’s and in compliance with all other applicable federal, state and local laws, rules, regulations and requirements of the Territory and at the time of shipment shall not be adulterated or misbranded within the meaning of the Act. It is understood, and Novartis agrees, that it will be accountable for any act or omission of any third party acting for or on behalf of Novartis to comply with Novartis’ obligations under this Agreement.
Manufacturing Activities. The Product, including all Samples, to be manufactured by or for Depomed for sale in the Territory shall be manufactured to meet applicable specifications for the Product in accordance with the NDA, cGMP and in compliance with all other applicable Legal Requirements.
Manufacturing Activities. A. The Parties shall reasonably consult on all matters relating to the manufacture of the Key Biochemistry Components and Sample Collection Kits.
Manufacturing Activities. A description of the Manufacturing Activities to be performed may be contained in statements of work attached as individual exhibits to this Agreement in consecutively numbered “Exhibit A’s”, beginning with Exhibit X-0, X-0, X-0 and so forth (each a “Statement of Work” or “SOW”). Each SOW shall be executed by a duly authorized representative of each Party and shall be subject to and deemed a part of this Agreement upon execution. To the extent that any terms and conditions set forth in a SOW conflict with the terms and conditions set forth in this Agreement (excluding other SOWs), the terms and conditions of this Agreement shall control, unless otherwise expressly agreed upon by the Parties in such SOW.
Manufacturing Activities. With respect to the Manufacturing Activities performed hereunder, Seller shall, as applicable, manufacture, supply or assemble the Products or Finished Devices initiated and developed by Buyer in accordance with the Specifications agreed to by Seller and Buyer. Seller will exercise best efforts in the fulfillment of its obligations hereunder and its performance will be in accordance with the regular practices of the injection molded plastics industry and medical device contract manufacturing and the terms and conditions contained herein.
Manufacturing Activities. With respect to Manufacturing activities for a particular Collaboration Program in the Territory following Takeda’s exercise of its Option for such Collaboration Program, the JPT shall:
Manufacturing Activities. The Manufacturing Lead shall be responsible for Manufacturing or having Manufactured (using a reputable Third Party Provider) each Research Biologic, Optioned Biologic and Optioned Product, as applicable. The Manufacturing Lead shall use Commercially Reasonable Efforts to [***]. The Manufacturing Lead shall obtain supply of the required quantities of Optioned Biologics, Optioned Product and placebo used in Clinical Studies, or otherwise to support the Development activities to be conducted under a Development Plan, either by performing Manufacturing by itself or through its Affiliates, or from a reputable Third Party Provider of manufacturing services, in each case until [***]. Following [***], the Manufacturing Lead will have the sole right to determine which of its or a Third Party Provider’s manufacturing sites will be used to manufacture the Optioned Product or component of the Optioned Product and may transfer the Manufacturing from one site to another, so long as such transfer would not reasonably be likely to have a material adverse effect on continued supply or, unless Denali has exercised the Denali Worldwide Royalty Option with respect to the Optioned Product, [***] increase in costs incurred in connection with or as a result of such transfer. Notwithstanding the foregoing, prior to any such transfer, the Manufacturing Lead will notify the Non-Manufacturing Lead of its intention to transfer Manufacturing from one site to another and shall permit the Non-Manufacturing Lead to carry out an audit of the proposed new site before such transfer takes place. In the event that the Manufacturing Lead [***] then, at the request of the Non-Manufacturing Lead, [***].
Manufacturing Activities. Subject to Section 17.5, PPI shall manufacture and supply, or procure the manufacture and supply of, the Product in accordance with the terms and conditions of the Supply Agreement.
