Third Party Manufacturers. The Parties acknowledge that Intellia may use one or more Third Party contract manufacturers to manufacture such Regeneron Products pursuant to Section 8.2(a); provided that the selection of such Third Party contract manufacturer shall be subject to Regeneron’s prior written approval, not to be unreasonably withheld, conditioned or delayed. Intellia will give Regeneron [***] days’ written notice (the “Rejection Period”) prior to engaging any Third Party contract manufacturer for manufacture of pre-clinical Regeneron Products hereunder, and permit Regeneron to review such proposed Third Party contract manufacturer within such Rejection Period. If Intellia provides written notice to Regeneron of its intended engagement of a Third Party contract manufacturer to manufacture pre-clinical Regeneron Product pursuant to Section 8.2(a) and Regeneron either (i) consents to such Third Party manufacturer or (ii) Regeneron does not provide written notice of its reasonable rejection of such Third Party contract manufacturer within the Rejection Period, then Regeneron shall have accepted or be deemed to have accepted, respectively, such Third Party contract manufacturer as a permitted Third Party manufacturer hereunder. If Regeneron provides its written rejection of such Third Party contract manufacturer within such Rejection Period, then (x) Intellia shall not utilize such Third Party contract manufacturer to manufacture Regeneron Product to be supplied to Regeneron pursuant to Section 8.2(a), and (y) the Parties shall discuss and mutually agree upon an alternative Third Party contract manufacturer acceptable to both Parties and Intellia shall exercise reasonable, good faith efforts to enter into a contract with such Third Party contract manufacturer for supply of such Regeneron Products thereunder, or (z) Regeneron shall have the right to enter into a contract with a Third Party contract manufacturer for supply of such Regeneron Products to Regeneron, provided, further, that in each such case (y) and (z), Intellia shall ensure that copies of all Know-How Controlled by Intellia (or any of its Affiliates) necessary or useful for the manufacture of such Regeneron Product in accordance herewith shall be provided to such Third Party contract manufacturer, in accordance with this Agreement, which manufacturing shall be performed in accordance with CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN...
Third Party Manufacturers. You may have a third- party manufacturer make Licensee Products incorporating the Licensed IP Cores for you if: (i) the resulting Licensee Products must be made for sale or use only by you; (ii) you provide the Licensed IP Cores to the manufacturer solely as embedded into the GDS file for the complete Licensed Product, and only for the purpose of making the Licensee Products for you, and subject to confidentiality provisions that are at least as protective as those in this Agreement; and
Third Party Manufacturers. RigNet is not a manufacturer of any Equipment or Goods nor responsible for any problems arising from the use of any equipment manufactured by third parties in connection with Services. To the extent that any Goods are sold to Customer such Goods ZLOO EH VROG ³$6 ,6 :+(5 shipping or insurance, F.C.A. RigNet designated shipping point, and Customer shall look solely to any third-party manufacturers for any warranty on the Goods.
Third Party Manufacturers. Where this Agreement provides that Acorda shall use Commercially Reasonable Efforts to obtain the consent of or response from one of its Third Party manufacturers, then, to the extent that Licensee has been allowed to interact directly with such Third party Manufacturer with respect to such matters, Licensee shall also be required to use Commercially Reasonable Efforts to obtain such result.
Third Party Manufacturers. CHI may use a third party manufacturer to manufacture any Product, with or without the approval of Distributor. If CHI uses a third party manufacturer to manufacture any Product, CHI shall enter into a binding written agreement with such manufacturer (a “Third Party Agreement”) prior to the provision of any Distributor Confidential Information to such third party. Such Third Party Agreement shall (i) provide for the protection of any Distributor Confidential Information provided to such third party manufacturer on substantially equivalent terms to those contained in this Agreement and (ii) provide limitations on the disclosure and use of such Distributor Confidential Information that are substantially equivalent to those contained in this Agreement. CHI shall be responsible for any acts or omissions of such third parties in breach of CHI’s representations, warranties and obligations under this Agreement to the same extent as if CHI had committed the breach itself. CHI shall use commercially reasonable efforts to monitor and enforce its Third Party Agreements as required to ensure the adequate protection of Distributor’s rights and Distributor’s Confidential Information and shall promptly notify Distributor of any actual or suspected breach thereof.
Third Party Manufacturers. In the event Spark has or will contract with Third Party Manufacturers with respect to Compound or Licensed Product, Spark will, upon Pfizer’s request, grant to Pfizer reasonable access and permission to engage in substantive discussions with Spark’s Third Party manufacturers of any Compound or Licensed Product, and during the Collaboration Period, at Pfizer’s request, Spark will meet with any and all current or potential Third Party manufacturers of any Compound or Licensed Product.
Third Party Manufacturers. Orexigen may subcontract any or all of its obligations pursuant to this Article 4 to Third Party manufacturers (the “Third Party Manufacturers”) with Takeda’s prior written consent, which consent shall not be unreasonably withheld, conditioned, or delayed. Orexigen shall not amend any agreement with a Third Party Manufacturer in any manner that could have a material impact on the Manufacture of Products for Takeda under this Agreement or Takeda’s ability to Commercialize or Develop the Products in the Territory without Takeda’s prior written consent, which consent shall not be unreasonably withheld, conditioned, or delayed. Orexigen shall provide Takeda with a copy of each amendment to an agreement with a Third Party Manufacturer promptly after its execution. For purposes of this Section 4.3, the term “manufacturer” is considered to be inclusive of all facilities designated in the corresponding section of the NDA. These include but are not limited to testing laboratories and packaging facilities. Takeda hereby consents to the Manufacture of the Product by the Third Party Manufacturers set forth on Exhibit 4.3. Orexigen acknowledges that it has entered into Manufacturing agreements with the Third Party Manufacturers set forth on Exhibit 4.3, under which such Third Party Manufacturers undertake the Manufacture of Product or active pharmaceutical ingredients contained in the Product covering a period of at least [***] ([***]) years after First Commercial Sale. [***] Orexigen shall be responsible for the day-to-day management of all Third Party Manufacturer relationships.
Third Party Manufacturers. Without limiting CyDex’s responsibility under this Agreement, CyDex shall [***].
Third Party Manufacturers. To the extent that Supplier uses a third-party manufacturer for any of the Products, then Supplier shall monitor and ensure that such third-party manufacturer is in compliance with the manufacturing standards set forth in this Quality Agreement. Subsequent to the execution of this Quality Agreement, Supplier shall comply with the provisions of this Quality Agreement prior to any additional use of third-party manufacturers for any of the Products. Supplier shall ensure that any third-party manufacturer complies with Company’s inspection and audit rights as set forth in this Quality Agreement with respect to such third party’s manufacturing facilities and records that relate to the Products.
Third Party Manufacturers. Upon notice to Supplier, Customer has the right to assign to a third-party manufacturer Customer’s obligation to purchase Contract Products covered by any Agreement. Customer will receive any benefit from Supplier for the volume of Contract Products purchased by Customer’s third-party manufacturers, including calculations for volume discount pricing or rebates that may be achieved based on Customer’s spend with Supplier. Supplier agrees to provide the same terms and conditions as set forth in any Agreement related to prices and Lead Time to such third-party manufacturer. In the event of assignment to a third-party manufacturer, Customer reserves the right at any time to revert the purchase back to Customer or assign the purchase to an alternative third-party manufacturer. In the event the third-party manufacturer fails to comply with the agreed payment terms, Supplier will provide written notification to the third-party manufacturer, with a copy to Customer, requesting immediate payment. Customer will use commercially reasonable means to assist in brokering a resolution of any such claim, but Customer will not be required to take any action that would materially impair its ability to meet delivery and quality requirements for Final Products.
