Second Source Supplier Sample Clauses

Second Source Supplier. In order to ensure a continuous supply of PRODUCT to meet customer demand and mitigate the impact of any shortage of PRODUCT, ENDOCEUTICS shall use commercially reasonable efforts to maintain at all times a second source supplier for the Manufacture of the Drug Product and API. In furtherance thereof, as soon as reasonably practicable but in no event later than twenty-four (24) months from the Execution Date, ENDOCEUTICS shall identify and transfer Technology IP to an appropriate second source supplier of the API, and, the Parties shall validate such second source supplier in a manner that is reasonably acceptable to both Parties, including by AMAG providing reasonable assistance, [***], regarding the identification, appointment, Technology IP transfer and validation of any proposed second source supplier of the API. After a second source supplier for the Manufacture of API is identified, appointed, and validated, ENDOCEUTICS shall [***] maintain at all times a second source supplier for the Manufacture of API. [***]. If ENDOCEUTICS fails to identify, appoint, transfer Technology IP, validate and cooperate with AMAG in seeking Regulatory Approval of and maintain a second source supplier as required by this Section 6.1, in the time frame set forth in this Section 6.1, AMAG shall have the right, [***], to identify, appoint and validate a second source supplier of the Drug Product or API, as applicable, provided that AMAG has first provided ENDOCEUTICS with [***] prior written notice of its intent to exercise its rights set forth in this sentence and ENDOCEUTICS does not, within such [***] period, provide AMAG with documentation reasonably evidencing ENDOCEUTICS’ use of commercially reasonable efforts in establishing such a second source supplier and its on-going plans with respect thereto. [***].
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Second Source Supplier. DEBIOTECH shall, promptly after the First Introduction Date in the USA, take all reasonably necessary measures in order to have a second source Cassette manufacturer (reasonably acceptable to IMED as to reliability, quality, technical capability, financial capability and creditworthiness) ready to begin Cassette supply within six (6) months from any first source Supply Interruption (as hereinafter defined), such second source manufacturer being able to fulfill all required manufacturing standards hereunder, including those set forth in Article 11.1(a) and 11.2 hereunder, and to supply the required orders from IMED, according to the rolling forecasts and Firm Orders communicated to DEBIOTECH as mentioned in Article 10.1. In addition, DEBIOTECH may at any time have a second source Pump and/or Accessory manufacturer (reasonably acceptable to IMED as to reliability, quality, technical capability, financial capability and creditworthiness) ready to begin Pump and/or Accessory supply within six (6) months from any first source Supply Interruption, such second source manufacturer being able to fulfill all required manufacturing standards hereunder, including those set forth in Article 11.1(a) and 11.2 hereunder, and to supply the required orders from IMED, according to the rolling forecasts and Firm Orders communicated to
Sample 1
Second Source Supplier. Nothing in this Agreement shall preclude Aimmune from arranging for the Processing, Testing and supply of Bulk Product from one (1) or more third-party supplier(s) at any time, in Aimmune’s sole discretion; provided that [***]. In the event that Aimmune chooses to use a second source supplier for the Processing, Testing and supply, or solely Release Testing, of Bulk Product, CoreRx shall [***].
Sample 1
Second Source Supplier. 6.1 For a period of two (2) years from the Effective Date hereof, in the event that Licensee, its Affiliates and/or Subsidiaries require a second source supply for the production of Licensed Product, Ciba shall have an option for the right of first refusal to become the second source supplier for Licensee, its Affiliates and/or Subsidiaries.
Sample 1
Second Source Supplier. Adolor has the right to qualify a second supplier in advance of a Supply Failure. Adolor may deliver the Deliverable Documents to a second supplier and otherwise use the Deliverable Documents to qualify a second supplier. Corium will provide Adolor with the Deliverable Documents upon the target date set forth in Exhibit A (unless the Agreement is terminated either by Adolor for its business convenience or by Corium for Adolor’s material, uncured default prior to such target date in accordance with the terms of the Agreement), provided, however, that the foregoing shall not be construed as requiring Corium to create Deliverable Documents after any termination of this Agreement pursuant to Section 7.2 hereof. For the avoidance of doubt, in the situation where Adolor is qualifying a second supplier, Corium will not provide training and will not create or provide any documents (other than the Deliverable Documents as described above) to assist in such qualification, nor shall Corium take any action to delay or prevent Adolor’s qualification of a second supplier. To the extent that they contain Corium Confidential Information, the Deliverable Documents will be Corium Confidential Information that will be subject to the nondisclosure provisions of this Agreement and Adolor will impose confidentiality obligations on second suppliers that are consistent with such provisions.
Sample 1
Second Source Supplier. Upon the Effective Date, Xxxxxx shall take all necessary actions to ensure that Xxxxxx is able to meet requirements of Indevus for Product, including compliance with cGMPs and all other regulatory requirements for manufacturing and testing Product. Any second source supplier shalI demonstrate capability to meet Indevus' manufacturing requirements including compliance with cGMPs and all other regulatory requirements. If at any time during the Term for any reason Xxxxxx shall be unable to manufacture and deliver Product in accordance with the terms of this Agreement or in sufficient quantities to satisfy Indevus' forecasted requirements for Product on the requested delivery date, Xxxxxx shall immediately so notify Indevus in writing, advising as to the period for which such inability to manufacture and deliver shall continue. In the event such inability is anticipated to or shall continue for [*] days or more, Indevus may use another manufacturer/supplier of Product and Xxxxxx will transfer Compound and know how to such manufacturer/supplier so that such nominated manufacturer/supplier can supply *CONFIDENTIAL TREATMENT REQUESTED Indevus for that period of time Xxxxxx is unable to supply Product in accordance with the terms of this Agreement and with Indevus' requirements. In such event, Indevus may cancel all outstanding Xxxxxx purchase orders and purchase any or all of its requirements of Product from such other manufacturer/supplier, limited to the period in which Xxxxxx is unable to supply Product in accordance with the terms of this Agreement and with Indevus' requirements, and provided that Indevus shall reinstate Xxxxxx as exclusive supplier of Product within [*] of notification by Xxxxxx to Indevus of Xxxxxx' ability to meet Indevus' forecasted requirements of Product in accordance with the terms of this Agreement. To the extent not otherwise set forth in this Section 7.2, issues relating to a second source of supply shall be governed by the provisions of Section 3.7 of the License Agreement
Sample 1
Second Source Supplier. DEBIOTECH shall, promptly after the First Introduction Date in the USA, take all reasonably necessary measures in order to have a second source Cassette manufacturer (reasonably acceptable to IMED as to reliability, quality, technical capability, financial capability and creditworthiness) ready to begin Cassette supply within [CONFIDENTIAL TREATMENT REQUESTED] from any first source Supply Interruption (as hereinafter defined), such second source manufacturer being able to fulfill all required manufacturing standards hereunder, including those set forth in Article 11.1(a) and 11.2 hereunder, and to supply the required orders from IMED, according to the rolling forecasts and Firm Orders communicated to DEBIOTECH as mentioned in Article 10.1. In addition, DEBIOTECH may at any time have a second source Pump and/or Accessory manufacturer (reasonably acceptable to IMED as to reliability, quality, technical capability, financial capability and creditworthiness) ready to begin Pump
Sample 1
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Related to Second Source Supplier

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Product Supply The Parties shall reasonably cooperate and assist each other in transferring ownership of Product drug product and/or Product drug substance (such material, CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. collectively, the “Product Lots”) set forth in Exhibit A attached hereto as promptly as reasonably practicable following the Effective Date; provided, however, that neither Party shall be required to pay money to any Third Party, commence any litigation with, or offer or grant any accommodation (financial or otherwise) to any Third Party. Such Product Lots shall be delivered EXW (Ex Works) (Incoterms 2010) AMGEN, Thousand Oaks, California. Any expense for shipment shall be borne by AKERO (including any import or export duties or taxes). Subject to the terms of this Section 5.4 and Section 6.2 (Additional AMGEN Warranties), AMGEN transfers the Product Lots to AKERO “as is”, and makes no other representation to AKERO in connection therewith. The Parties have entered into a Quality Agreement substantially in the form attached hereto as Exhibit F, dated as of the date hereof, governing the quality of the Product Lots to be supplied pursuant to this Section 5.4. For the avoidance of doubt, Product Lots consisting of drug product as set forth in Exhibit A supplied pursuant to this Section 5.4 shall be labeled for their intended clinical use as set forth in Exhibit A and the labeling of any Product drug product manufactured after the Effective Date shall be the responsibility of AKERO. Except for the Licensed Materials and such Product Lots to be transferred to AKERO, AKERO shall be responsible for, and shall bear the cost of, obtaining (whether by manufacturing or causing to be manufactured) research, clinical and commercial supplies of the Product. From and after the Effective Date, AKERO shall be responsible for all costs and expenses in connection with the storage of, and any stability studies performed on, the Product Lots.

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

  • TECHNICAL SUPPORT SERVICES 2.1 The technical support services (the "Services"): Party A agrees to provide to Party B the relevant services requested by Party B, which are specified in Exhibit 1 attached hereto ("Exhibit 1").

  • Supplier A manufacturer, fabricator, distributor, supplier, or vendor of goods or equipment in connection with the Work, or any other party having a Contract or Purchase Order with the Contractor or with a Subcontractor to furnish materials or equipment to be incorporated in the Work by the Contractor or a Subcontractor.

  • Software License Agreement 1) Customers acquiring software licenses under the Contract shall hold, use and operate such software subject to compliance with the Software License Agreement set forth in Appendix D of this Contract. No changes to the Software License Agreement terms and conditions may be made unless previously agreed to between Vendor and DIR. Customers may not add, delete or alter any of the language in Appendix D; provided however, that a Customer and Vendor may agree to additional terms and conditions that do not diminish a term or condition in the Software License Agreement, or in any manner lessen the rights or protections of Customer or the responsibilities or liabilities of Vendor. Order Fulfiller shall make the Software License Agreement terms and conditions available to all Customers at all times.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Compliance Support Services Provide compliance policies and procedures related to services provided by BNY Mellon and, if mutually agreed, certain of the BNY Mellon Affiliates; summary procedures thereof; and periodic certification letters. · Such Compliance Support Services are administrative in nature and do not constitute, nor shall they be construed as constituting, legal advice or the provision of legal services for or on behalf of a Fund or any other person, and such services are subject to review and approval by the applicable Fund and by the Fund’s legal counsel. · Provide access to Fund records so as to permit the Fund or TRP to test the performance of BNY Mellon in providing the services under this Agreement. · Such Compliance Support Services performed by BNY Mellon under this Agreement shall be at the request and direction of the Fund and/or its chief compliance officer (the “Fund’s CCO”), as applicable. BNY Mellon disclaims liability to the Fund, and the Fund is solely responsible, for the selection, qualifications and performance of the Fund’s CCO and the adequacy and effectiveness of the Fund’s compliance program.

  • Supply Agreement The Supply Agreement shall have been executed on behalf of the Seller and delivered to the Purchaser.

  • Quality Agreement Concurrently with execution of this Agreement, the Parties will enter into an agreement that details the quality assurance obligations of each Party with respect to the Manufacture and supply of Supplied Products under this Agreement (the “Quality Agreement”). Each Party shall perform its obligations under the Quality Agreement in accordance with the terms and conditions thereof. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the provisions of the Quality Agreement shall govern.

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