Third Party Manufacturer Sample Clauses

Third Party Manufacturer. Notwithstanding the terms and conditions of Section 6.1(a) of the License Agreement, Cordis shall be the sole manufacturer of the Product during the Term of this Agreement, unless (i) Cordis fails to supply Product, as set forth in Section 10.2, (ii) Cordis provides written notice to SRM that it cannot meet SRM’s requirements of supply of Product, (iii) Cordis is not able or willing to make the improvements, modifications or changes to the Product requested by SRM according to the terms and conditions of Section 2.3.2, (iv) the Cordis facility is subject to a consent decree or injunction which materially adversely affects Cordis’ ability to supply SRM Product pursuant to the terms of this Agreement, or (v) the PRECISE® carotid stent is subject to an investigation or enforcement action by a Regulatory Authority or has been recalled, in either case in a way that materially adversely affects Cordis’ ability to supply SRM pursuant to the terms of this Agreement. If any of the foregoing situations occurs, upon SRM’s election, (A) Cordis shall permit Nitinol Devices and Components, Inc. or a third party Manufacturer to provide supply of Product to SRM in accordance with Section 6.1 of the License Agreement, and (B) Cordis shall remain a manufacturer and supplier of Product to SRM under Sections 10.1(i)-(iii) to the extent Cordis is able to do so, even if Nitinol Devices and Components, Inc. or a third party Manufacturer is permitted also to supply product to SRM under Section 10.1(A). If this Agreement is terminated by SRM according to Section 11.3.2 or by SRM or Cordis according to Section 11.3.3, or if Cordis terminates this Agreement for breach according to Section 11.2, or if, under subsection (v) of this Section, further manufacture by Nitinol Devices and Components, Inc. or a third party Manufacturer would not be legally permissible due to the nature of the investigation, enforcement action or recall (but only to the extent of the duration of the impermissibility), SRM shall not be permitted to have Nitinol Devices and Components, Inc. or a third party Manufacturer manufacture Product. For the avoidance of doubt, and notwithstanding anything in this Agreement to the contrary, the Parties acknowledge and agree that SRM, without Cordis’ consent, may work directly with Nitinol Devices and Components, Inc. for the development and supply of next-generation products that materially expand or change the Specifications herein.
Third Party Manufacturer. UGNX hereby acknowledges and agrees that KHK will be entitled, in its sole discretion, to perform any or all of its obligations under this Article 8 by subcontracting any or all of such obligations to Third Party manufacturers (each, a “Third Party Manufacturer”) in any country. In the event that KHK elects to subcontract any or all of its [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. obligations under this Agreement to a Third Party Manufacturer, KHK shall use Commercially Reasonable Efforts to: (a) coordinate the transfer of such obligations with UGNX, including provision to UGNX of the right to audit any facility of the Third Party Manufacturer used or to be used for the manufacture of the applicable Licensed Products and (b) involve UGNX in decisions regarding process changes that could affect the comparability of the Licensed Products. KHK will be solely responsible for Development costs resulting from any change to a Third Party Manufacturer.
Third Party Manufacturer. Nothing herein shall be deemed to prevent Licensee from causing the Licensed Products to be manufactured by third parties subject to and in accordance with the terms and conditions of this Agreement on condition that Licensee shall indemnify Licensor against any loss or damage arising as a result of any breach by any third party manufacturer of Licensee=s obligations under the Agreement or otherwise arising out of acts, omissions or misrepresentations by any third party manufacturer in derogation of Licensor=s rights in and to the Property. If any manufacturing of the Licensed Products shall be conducted outside the Territory, in addition to any other obligations under this Agreement, Licensee shall advise Licensor in advance of the name, address and manufacturing location and any third party contractors shall sign the “Manufacturer=s Agreement” set forth in Exhibit A annexed hereto. 07/30/03 Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to a confidentiality request. Omissions are designated [*****]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission with the confidentiality request.
Third Party Manufacturer. ULURU shall, in accordance with the terms of this Section 2.8, establish a Manufacturing Facility (operated by a Third Party manufacturer) in compliance with the FDA's requirements, including, without limitation, compliance with the written requirements of ALTRAZEAL as provided as of the Effective Date. As of the Effective Date, ULURU has identified to ALTRAZEAL the Third Party manufacturer it intends to use to Manufacture and supply to ALTRAZEAL the Product and the location of the Facility. ULURU shall promptly provide ALTRAZEAL with access to the Facility for inspection by ALTRAZEAL. In addition, ULURU shall promptly provide ALTRAZEAL with information requested by ALTRAZEAL regarding the Third Party manufacturer (including, without limitation, any information requested by ALTRAZEAL in accordance with ALTRAZEAL’s due diligence, its GMP audit procedures and its "Level One Compliance Assessment"). During the Term and upon reasonable prior notice to ULURU, ALTRAZEAL shall have the right, from time to time, to audit the Facility and the performance of the Third Party manufacturer to ensure that the Facility and the Third Party manufacturer are in compliance with GMP and ALTRAZEAL’s other manufacturing standards. Any such audits or inspections shall be undertaken by ALTRAZEAL in accordance with the provisions of Section 3.5.
Third Party Manufacturer. Kyowa Kirin hereby acknowledges and agrees that Reata shall be entitled, in its sole discretion, to perform any or all of its obligations under this ARTICLE VIII by subcontracting any or all of such obligations to Third Party manufacturers (each, a “Third Party Manufacturer”) in any country. Any such subcontracting arrangement shall be subject to the following: (a) such Third Party Manufacturer (excluding any Third Party Manufacturer already used by Reata as of the Effective Date) shall be subject to Kyowa Kirin’s prior approval, not to be unreasonably withheld; (b) any use of a Third Party Manufacturer shall not limit Reata’s obligations hereunder and Reata shall remain fully liable to Kyowa Kirin for its obligations under this ARTICLE VIII and for all actions or omissions of any such Third Party Manufacturer; (c) Reata shall enter into an agreement with such Third Party Manufacturer that is subject to and consistent with the terms and conditions of this Agreement, under which such Third Party Manufacturer agrees to be subject to the applicable terms and conditions of this Agreement and which allows Reata to fully comply with its obligations hereunder, including by providing for any data, information or intellectual property generated by such Third Party Manufacturer with respect to Licensed Products to be included within the rights and licenses granted to Kyowa Kirin hereunder, by requiring the applicable provisions of this ARTICLE VIII to apply to such Third Party Manufacturer (including Kyowa Kirin’s back-up manufacturing rights and other provisions of this Section 8.4), and by imposing confidentiality restrictions at least to the extent provided for in ARTICLE XI.
Third Party Manufacturer. Ethypharm shall not subcontract its manufacturing and supply obligations hereunder to any third party; provided, however, upon the prior written consent of Ampio, Ethypharm shall be entitled to contract with a third party for the purposes of such party’s producing part or all of the Product, and maintaining quality control with respect to such Product, in lieu of and on behalf of Ethypharm (a “Third Party Manufacturer”) in which case Ethypharm shall remain liable to Ampio for all of its obligations, including but not limited to the performance of the Third Party Manufacturer, herein, and Ampio shall either (at Ethypharm’s discretion) start purchasing the Product directly from the Third Party Manufacturer (according to the same terms and conditions as apply to the supply of Product by Ethypharm to Ampio hereunder), or continue purchasing the Product through Ethypharm. Ethypharm shall give Ampio reasonable notice of any proposal to appoint a Third Party Manufacturer and shall satisfy all legal and regulatory requirements relating to any variation of the Regularity Approval relating to such appointment at its own cost and shall procure for Ampio reasonable inspection and audit rights (which rights are no less favorable to Ampio than those it possesses hereunder with respect to Ethypharm) in respect of the Third Party Manufacturer’s Manufacturing Site. Ethypharm shall warrant in writing to Ampio that the Third Party Manufacturer: (i) has and will maintain the requisite capacity to satisfy Ethypharm’s production and delivery obligations, and to meet Ampio’s order requirements, hereunder with respect to the Product in accordance with the Specifications and the terms and conditions of this Agreement; (ii) complies and will comply with all applicable laws and holds all applicable licensees and permits necessary for the manufacture of the Product in compliance with cGMP; (iii) has and will have the right to use all related intellectual property and Confidential Information of Ethypharm necessary to manufacture the Product in accordance with the Specifications and the terms and conditions of this Agreement.
Third Party Manufacturer. In the event Licensee intends to engage one or more manufacturers to make Licensed Products, it shall give prompt written notice of such intention to GEHC and provide GEHC with an opportunity to negotiate in good faith with Licensee to provide such manufacturing services, which opportunity shall extend for no less than thirty (30) days from the date of GEHC’s receipt of such written notice. Subject to the foregoing sentence, nothing in this section shall be construed as restricting Licensee’s rights to negotiate, agree or contract with any third party the right to manufacture Licensed Products for Licensee at any time.
Third Party Manufacturer. Once ADESTO has engaged with a third party manufacturer as permitted above, ADESTO may develop that relationship in a manner that ADESTO deems to be commercially reasonable and WAFERS ordered under that relationship will be excluded from the calculation to determine whether ADESTO has met its purchase commitment. ADESTO is not obligated to revert back to ALTIS even if ALTIS later remedies the original condition that permitted ADESTO to engage with the third party manufacturer, except for a capacity shortfall that is remedied by ALTIS within [*].
Third Party Manufacturer. Nothing herein shall be deemed to prevent Licensee from causing the Licensed Products to be Inanufactured by other parties, subject to the terms and conditions of this Agreement. If any manufacturing of the Licensed Products shall be conducted outside the Territory, in addition to any other obligations under this Agreement, Licensee shall advise Licensor in advance of the nmne, address and manufacturing location and any third party contractors shall sign the "Manufacturer's Agreement" set forth in Exhibit A annexed hereto.
Third Party Manufacturer. In the event that SkyePharma contracts with a Third Party to manufacture, test and/or package the Product (either as the primary or secondary source of supply), Endo shall be given the opportunity to review and comment on such manufacturing agreement in advance of its execution, and SkyePharma shall give good faith consideration to Endo's comments. Such Third Party manufacturing agreement(s) shall provide that Endo shall be an intended third party beneficiary of such Third Party manufacturer's obligations to SkyePharma thereunder, including with rights of direct enforcement by Endo. In addition, each Third Party manufacturing agreement shall provide, in substance, that, in the event that SkyePharma, or any other Person acting on behalf of SkyePharma or its estate pursuant to any Bankruptcy Laws, shall seek or obtain a Bankruptcy Rejection of such Third Party manufacturing agreement, then the Third Party manufacturer shall (i) timely exercise its rights to continue any and all licenses (if any) thereunder, pursuant to 11 U.S.C. § 365(n) of the Bankruptcy Laws, and (ii) to the extent that Bankruptcy Rejection effectively terminated the Third Party manufacturing agreement, immediately enter into an agreement with Endo for the Product in the Territory, on substantially the same terms and conditions. The Third Party manufacturing agreements may contain such additional terms and conditions as SkyePharma and the Third Party manufacturer shall agree to, subject to the review (but not the approval) of the JMC prior to the execution of such Third Party manufacturing agreement and provided that such additional terms and conditions do not prejudice, reduce or limit Endo's rights under this Agreement (including this Section 3.2) or the Alliance Agreement.