Third Party Manufacturing Agreements Sample Clauses

Third Party Manufacturing Agreements. The Clinical Supply Agreement(s) and Commercial Supply Agreement(s) shall include provisions (a) requiring Alnylam to reasonably consult with Genzyme through the JSC regarding proposed supply agreements to be entered into between Alnylam and Third Party Manufacturers to the extent Products to be supplied to Genzyme will be manufactured under such Third Party supply agreements; and (b) requiring Alnylam to use commercially reasonable efforts to include in applicable supply agreements with Third Party manufacturers rights for Genzyme to enforce such agreements against such Third Parties as such agreements relate to the supply of Product(s) for the Genzyme Territory, including by identifying Genzyme as a third party beneficiary under such agreements, and if Alnylam is not able to negotiate such third party beneficiary rights for Genzyme’s benefit, provisions requiring Alnylam to enforce such Third Party supply agreements at Genzyme’s direction and expense as such agreements relate to the supply of the applicable Product(s) for the Genzyme Territory.
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Third Party Manufacturing Agreements. If Array proposes to enter into one or more new manufacturing agreements for Product for use in the United States, including without limitation any agreement with a Back-Up Manufacturer as contemplated under Section 9.4, or proposes to materially amend, renegotiate or renew any then-existing Third Party manufacturing agreements for Product for use in the United States, Array shall so notify Oncothyreon and the JCC prior to doing so, along with a detailed description of the proposed terms and circumstances. In addition, if Array proposes to enter into one or more new agreements for the supply of Product for use in the United States, Array shall provide to the JCC evidence of bids for such supply received from at least two (2) other suppliers. To the extent permitted by the potential Third Party manufacturer, Oncothyreon shall have the right to accompany Array on any and all audits and inspections of such Third Party’s facilities conducted in the course of manufacturer selection.
Sample 1
Third Party Manufacturing Agreements. If Array proposes to enter into one or more new manufacturing agreements for Product for use in the United States, including without limitation any agreement with a Back-Up Manufacturer as contemplated under Section 9.4, or proposes to materially amend, renegotiate or renew any then-existing Third Party manufacturing agreements for [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Product for use in the United States, Array shall so notify Oncothyreon and the JCC prior to doing so, along with a detailed description of the proposed terms and circumstances. In addition, if Array proposes to enter into one or more new agreements for the supply of Product for use in the United States, Array shall provide to the JCC evidence of bids for such supply received from at least two (2) other suppliers. To the extent permitted by the potential Third Party manufacturer, Oncothyreon shall have the right to accompany Array on any and all audits and inspections of such Third Party’s facilities conducted in the course of manufacturer selection.
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Third Party Manufacturing Agreements 
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Related to Third Party Manufacturing Agreements

  • 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.

  • 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.

  • 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.

  • Third Party Agreements Nothing in this Section 5.3 shall require any Party to violate any Contract or arrangement with any Third Party regarding the confidentiality of confidential and proprietary information relating to that Third Party or its business; provided, however, that in the event that a Party is required under this Section 5.3 to disclose any such information, such Party shall use commercially reasonable efforts to seek to obtain such Third Party’s consent to the disclosure of such information. The Parties also acknowledge that the Other Parties’ Auditors are subject to contractual, legal, professional and regulatory requirements which such auditors are responsible for complying with.

  • Sublicense Agreements Sublicenses shall be granted only pursuant to written agreements, which shall be subject and subordinate to the terms and conditions of this Agreement. Such Sublicense agreements shall contain, among other things, provisions to the following effect:

  • 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.

  • 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 [***].

  • 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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