API Supply Agreement Sample Clauses

API Supply Agreement. This API SUPPLY AGREEMENT (this “Agreement”) is entered into as of (the “Effective Date”) by and between Aratana Therapeutics Inc., a Delaware corporation (“Aratana”) and RaQualia Pharma Inc., a Japanese corporation (“RaQualia”). Aratana and RaQualia are referred to herein individually as a “Party” and collectively as the “Parties”.
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API Supply Agreement. EXECUTION VERSION 8
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API Supply Agreement. EXECUTION VERSION 9 Each Purchase Order must be submitted with either (i) a certificate of available Procurement Quota or a completed DEA Form 222 on a Product by Product basis or (ii) specify on a Product by Product basis the amounts that are contingent upon receipt of available Procurement Quota. In the event that Company specifies that all or a portion of any Product submitted for a Purchase Order is contingent upon receipt of Procurement Quota by it of its Contract Manufacturer, only the portion of such Purchase Order for which Procurement Quota is available shall be binding upon Supplier, and with respect to any portion of such Purchase Order for which Procurement Quota is not available, the supply and purchase thereof, including but not limited to delivery dates, shall be subject to Article 15.
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API Supply Agreement. (i) Promptly following the Closing Date, Lilly shall assist ViroPharma in negotiating an agreement with [***] for the supply of bulk API used to manufacture the Marketed Product in the Territory in form substantially similar to the API Supply Agreement, with any changes thereto to be approved by ViroPharma in its sole discretion. In the event that such an agreement has not been entered into, Lilly shall assign the API Supply Agreement to ViroPharma, together with the Quality Agreement described therein and all other agreements related thereto, and the timing of such assignment will be at Lilly’s discretion upon reasonable notice to ViroPharma but will occur no earlier than after the Third Person Supply Chain has all necessary Regulatory Approvals for the manufacture and supply of Marketed Product and no later than the end of the Contract Period (as defined in Section 8.1 of the Manufacturing Agreement) of the Manufacturing Agreement; provided that following such assignment, Lilly shall remain obligated for any liabilities or obligations arising under the TPSC Agreements prior to the assignment.
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API Supply Agreement. The Parties shall negotiate in good faith and attempt to agree within [***] after the Effective Date upon a supply agreement for the supply of Compound API by TESARO to Company at TESARO’s Manufacturing Cost [***] (except API supplied for Company’s CMC or clinical Development and technology transfer needs will be at TESARO’s Manufacturing Cost [***]) (the “API Supply Agreement”) and a related quality agreement. The API Supply Agreement shall include: (i) technology transfer obligations of TESARO and Confidential 70 [***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Technology Transfer Costs to be paid by Company, its Affiliates and Third Party contractors; and (ii) provisions regarding allocation of Compound API between Company and TESARO in the event of shortages, which shall be consistent with Section 7.7 unless otherwise agreed by the Parties. Additionally, the Parties may agree that Company or its Affiliates (directly or indirectly through a Third Party) shall serve as a second source supplier of Single Agent Products or Compound API for use in the Manufacture of Single Agent Products, in which case TESARO would have audit rights with respect to all manufacturing sites where Compound API is manufactured for use in Single Agent Products used in Clinical Trials sponsored by TESARO or sold by TESARO under its trade name.
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API Supply Agreement. ETHYPHARM represents and warrants to RELIANT that it has in place (and will maintain during the Term of this Agreement) one or more written binding long-term supply agreements with an API supplier approved by the FDA to ensure supply of micronized API to ETHYPHARM sufficient to meet ETHYPHARM’s obligations to RELIANT under this Agreement (including validation and full FDA approval of such API, in each case at ETHYPHARM’s sole expense).
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Related to API Supply Agreement

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

  • Supply Agreements For a period of three years from the consummation of the IPO, Odetics shall not unilaterally terminate or assign its guarantee obligation with respect to any supply agreement pursuant to which it has guaranteed the performance by ATL of ATL's obligations, unless such suppliers have consented to the termination or assignment of such guarantee.

  • 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.

  • 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.

  • License Agreement The Trust shall have the non-exclusive right to use the name "Invesco" to designate any current or future series of shares only so long as Invesco Advisers, Inc. serves as investment manager or adviser to the Trust with respect to such series of shares.

  • Collaboration Agreement The Collaboration Agreement shall not have been terminated in accordance with its terms and shall be in full force and effect.

  • Marketing Agreement The Company shall have entered into, ------------------- executed and delivered the Marketing Agreement.

  • Development Agreement As soon as reasonably practicable following the ISO’s selection of a transmission Generator Deactivation Solution, the ISO shall tender to the Developer that proposed the selected transmission Generator Deactivation Solution a draft Development Agreement, with draft appendices completed by the ISO to the extent practicable, for review and completion by the Developer. The draft Development Agreement shall be in the form of the ISO’s Commission-approved Development Agreement for its reliability planning process, which is in Appendix C in Section 31.7 of Attachment Y of the ISO OATT, as amended by the ISO to reflect the Generator Deactivation Process. The ISO and the Developer shall finalize the Development Agreement and appendices as soon as reasonably practicable after the ISO’s tendering of the draft Development Agreement. For purposes of finalizing the Development Agreement, the ISO and Developer shall develop the description and dates for the milestones necessary to develop and construct the selected project by the required in-service date identified in the Generator Deactivation Assessment, including the milestones for obtaining all necessary authorizations. Any milestone that requires action by a Connecting Transmission Owner or Affected System Operator identified pursuant to Attachment P of the ISO OATT to complete must be included as an Advisory Milestone, as that term is defined in the Development Agreement. If the ISO or the Developer determines that negotiations are at an impasse, the ISO may file the Development Agreement in unexecuted form with the Commission on its own, or following the Developer’s request in writing that the agreement be filed unexecuted. If the Development Agreement is executed by both parties, the ISO shall file the agreement with the Commission for its acceptance within ten (10) Business Days after the execution of the Development Agreement by both parties. If the Developer requests that the Development Agreement be filed unexecuted, the ISO shall file the agreement at the Commission within ten (10) Business Days of receipt of the request from the Developer. The ISO will draft, to the extent practicable, the portions of the Development Agreement and appendices that are in dispute and will provide an explanation to the Commission of any matters as to which the parties disagree. The Developer will provide in a separate filing any comments that it has on the unexecuted agreement, including any alternative positions it may have with respect to the disputed provisions. Upon the ISO’s and the Developer’s execution of the Development Agreement or the ISO’s filing of an unexecuted Development Agreement with the Commission, the ISO and the Developer shall perform their respective obligations in accordance with the terms of the Development Agreement that are not in dispute, subject to modification by the Commission. The Connecting Transmission Owner(s) and Affected System Operator(s) that are identified in Attachment P of the ISO OATT in connection with the selected transmission Generator Deactivation Solution shall act in good faith in timely performing their obligations that are required for the Developer to satisfy its obligations under the Development Agreement.

  • 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.

  • Pharmacovigilance Agreement Within [***] after the Effective Date, BMS and the Company (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define and finalize the responsibilities the Parties shall employ to protect patients and promote their well-being in connection with the use of the Licensed Compound(s) until such time that all pharmacovigilance responsibilities have transferred from BMS to Company. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Licensed Compound(s). Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. Until such guidelines and procedures are set forth in a written agreement between the Parties (hereafter referred to as the “Pharmacovigilance Agreement”), the Party responsible for pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound(s) subject to all applicable regulations and guidelines. In the event that this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilled. Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

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