Technical Quality Agreement Sample Clauses

Technical Quality Agreement. Within sixty (60) days upon signing of this Agreement the Parties shall enter into a Technical Quality Agreement. The Technical Quality Agreement sets forth, among other things, certain tasks and responsibilities to be performed by each Party with respect to the Diagnostic Services and shall incorporate provisions permitting Shire and Shire Group Companies to audit the Facility and any alternate facility as well as other customary provisions, including the key terms regarding quality systems set forth in Section 3.12. In the event of any discrepancy or inconsistency between the tasks listed in such Technical Quality Agreement and the terms of this Agreement, the terms of the Technical Quality Agreement will govern with respect to quality matters, and the terms of this Agreement shall govern with respect to all other matters..
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Technical Quality Agreement. Within one (1) month after the Effective Date, the Parties shall enter into a separate Technical/Quality Agreement, in format suitable to meet applicable regulations relating to the production, storage, transportation and release of Products.
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Technical Quality Agreement. Within 3 months after the Effective Date, and in any event prior to the first Processing of Product hereunder, the parties shall negotiate in good faith and enter into mutually acceptable applicable technical quality agreements for the services (the “Quality Agreements”). Among other things, the Quality Agreement will set forth reporting requirements for out-of-specification results. The Quality Agreements in no way determine liability or financial responsibility of the parties for the responsibilities set forth therein. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreements with respect to quality-related activities, including compliance with cGMP, the provisions of the Quality Agreements shall govern. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreements with respect to any commercial matters, including ***Confidential Treatment Requested ***Text Omitted and Filed Separately with the Securities and Exchange Commission. Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and 230.406 allocation of risk, liability and financial responsibility, the provisions of this Agreement shall govern.
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Technical Quality Agreement. The parties shall enter into a Technical Quality Agreement on or about the date of this Agreement.
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Technical Quality Agreement. Annexed to and forming part of this Agreement is a copy of the Technical Quality Agreement between Xxxxxxx and the Customer, pursuant to which various roles and responsibilities are designated as assigned to one or the other of the Parties.
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Technical Quality Agreement. Separate from this 3rd Amendment, the Parties are revising the Technical & Quality Agreement. When the revision is agreed and executed by authorized quality representatives of the Parties, such revisions shall become part of the Technical & Quality Agreement, the terms and conditions of which shall be incorporated into the terms of the Agreement, as amended by the 1st, the 2nd, and 3rd Amendments.
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Technical Quality Agreement. The Supplier shall, and shall cause its Subcontractors to, perform the quality control and quality assurance testing specified in the Technical Quality Agreement. Unless otherwise explicitly agreed to by the Parties in a written document which acknowledges an exception or amendment to this Agreement:
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Technical Quality Agreement. The parties shall enter into a Technical & Quality agreement substantially in the form of the agreement attached hereto as Exhibit 7.3 within one-hundred and twenty (120) days following the Effective Date.
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Technical Quality Agreement. Separate from this 4th Amendment, the Parties have revised, approved and executed a Technical & Quality Agreement dated July 24, 2014 as updated by an Appendix signed on July 7, 2016. As such, the revised and updated Technical & Quality Agreement is hereby be incorporated into the terms of the Agreement, as amended by the 1st, the 2nd, 3rd and 4th Amendments.
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Related to Technical Quality Agreement

  • 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 Each Party will comply with the terms of the Quality Agreement in the performance of its obligations hereunder including record retention, audits and inspections, change control, adverse events and product recall. The Parties will conduct periodic Product quality reviews in accordance with the terms of the Quality Agreement.

  • Supply Agreement Buyer shall have executed and delivered the Supply Agreement to the Company.

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • 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.

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

  • Development Agreement That certain Development Agreement dated of even date herewith by and between the Company and Developer providing for the development of the Project on the Property, a copy of which is attached hereto as Exhibit C and incorporated herein by reference. Development Fee. As described in Section 6.8.

  • 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.

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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

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