Manufacturing and Supply Agreements Sample Clauses

Manufacturing and Supply Agreements. 8.3.3.1. The terms under which Novartis will Manufacture and supply Regional Antibody Candidates and Regional Licensed Products to Novartis pursuant to Section 8.3 will be set forth in a supply agreement to be entered into between the Parties (the “RLP Supply Agreement”) within [***] of either Party’s written request. The RLP Supply Agreement will contain customary terms and conditions, including quality, and otherwise be consistent with this Agreement and Novartis quality standards.
Sample 1Sample 2Sample 3See All (4)
AutoNDA by SimpleDocs
Manufacturing and Supply Agreements. Within six (6) months after the Effective Date, the Parties shall negotiate in good faith and enter into a definitive written clinical supply agreement, which will specify the terms of the Manufacturing and supply of Products by BioGenerics to Licensee or its designee to be used in non-clinical and Clinical Trials. The Parties shall negotiate in good faith and enter into a definitive written commercial supply agreement[***], which will specify the terms of the Manufacturing and supply of Products by BioGenerics to Licensee or its designee for commercial use (together with the clinical supply agreement, the “Manufacturing and Supply Agreements”). The Manufacturing and Supply Agreements shall be consistent with all of the terms and conditions in this Section 5.1, Exhibit 5.1 (Manufacturing and Supply by BioGenerics), and all other relevant provisions of this Agreement, and shall be agreements to supply all of Licensee’s, its Affiliates’ and Sublicensees’ requirements for the Products in the Territory and contain customary market terms including, without limitation, [***].
Sample 1Sample 2Sample 3
Manufacturing and Supply Agreements. Nanogen and Becton shall enter into Manufacturing and Supply Agreements for, respectively, the United States and outside of the United States (collectively, the "Manufacturing and Supply Agreements"). The Manufacturing and Supply Agreements shall provide for the following: ***CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION.
Sample 1Sample 2
Manufacturing and Supply Agreements. The Buyer Manufacturing and Supply Agreements and the Sellers Manufacturing and Supply Agreements, duly executed by the applicable Seller or its Affiliate;
Sample 1
Manufacturing and Supply Agreements. If Wave is the Manufacturing Lead for Licensed Compounds, Licensed Products, or Companion Diagnostics directed to a Licensed Target, then, within [***] pursuant to which (a) if Takeda is the Development Lead for the applicable Licensed Target, Wave would Manufacture and supply to Takeda the applicable Licensed Compounds, Licensed Products, and Companion Diagnostics directed to such Licensed Target for Development purposes (the “Clinical Supply Agreement”) and (b) Wave would Manufacture and supply to Takeda the applicable Licensed Compounds, Licensed Products, and Companion Diagnostics directed to such Licensed Target for Commercialization purposes (the “Commercial Supply Agreement,” and together with the Clinical Supply Agreement, the “Supply Agreements”). The Clinical Supply Agreement will contain all of the terms and conditions set forth on Schedule 7.7(a) (the “Clinical Supply Term Sheet”), and the Commercial Supply Agreement will contain all of the terms and conditions set forth on Schedule 7.7(b) (the “Commercial Supply Term Sheet,” and together with the Clinical Supply Term Sheet, the “Term Sheets”), and in addition each Supply Agreement will (a) provide that Wave will supply all applicable Licensed Compounds, Licensed Products, and Companion Diagnostics to Takeda at the Supply Price, (b) contain customary terms and conditions, including quality, and (c) otherwise be consistent with this Agreement. In the event that the Parties [***].
Sample 1
Manufacturing and Supply Agreements. 5.3.1 In the event that the requirements of Section 5.2 have been met such that Livzon will be Epirus’s Preferred Supplier, the Parties shall negotiate in good faith and use their respective Commercially Reasonable Efforts to enter into a definitive written pre-clinical and clinical supply agreement, [***], which will specify the terms of the Manufacture and supply of Collaboration Compounds and/or Collaboration Products for Epirus’s use in Pre-Clinical Development and Clinical Development activities in Epirus Territory [***] (each a “Clinical Supply Agreement”).
Sample 1
Manufacturing and Supply Agreements. 1. Drug Substance and Validation and Supply Agreement between SuperGen, Inc. and Ferro Pfanstiehl Laboratories, Inc. and its affiliates, effective as of July 2, 2003 and Amendments 1, 2, 3, 4, 5, and 6 thereto
Sample 1
AutoNDA by SimpleDocs
Manufacturing and Supply Agreements. On or prior to the Effective Date, ALZA and Menarini will, except in the event a Section 2.1 Closing does not occur by the Final Section 2.1 Closing Date, execute a mutually acceptable Non-Group E Market Manufacturing Agreement. Except in the event a Section 2.1 Closing does not occur by the Final Section 2.1 Closing Date, ALZA and GENUPRO agree to negotiate in good faith and execute a mutually acceptable Group E Market Manufacturing Agreement which shall provide for the supply of Agreement Product to GENUPRO for at least one year following Regulatory Approval in the US. In the event a Section 2.1 Closing does not occur by the Final Section 2.1 Closing Date, the Non-Group E Market Manufacturing Agreement and the Group E Market Manufacturing Agreement shall be of no effect and, subject to Section 14.2.2.2, ALZA and GENUPRO shall negotiate in good faith a GENUPRO Manufacturing Agreement and GENUPRO Quality Agreement under which ALZA will supply Agreement Product to GENUPRO for a limited time in those Group A Market, Group B Market, Group C Market and Group E Market countries where GENUPRO intends to use or sell Agreement Product.
Sample 1
Manufacturing and Supply Agreements. At or prior to the Closing, (i) Purchaser and J&J shall enter into, execute and deliver a manufacturing and supply agreement substantially to the effect set forth in Exhibit D (the "J&J Manufacturing and Supply Agreement") and (ii) Purchaser and Pfizer shall enter into, execute and deliver a manufacturing and supply agreement substantially to the effect set forth in Exhibit D (the "Pfizer Manufacturing and Supply Agreement").
Sample 1

Related to Manufacturing and Supply Agreements

  • 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.

  • 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.

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

  • 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.

  • 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 and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Manufacture and Supply BMS shall Manufacture or have Manufactured the BMS Study Drug in reasonable quantities needed, and at the points in time as agreed to by the Parties, for the Combined Therapy Clinical Trial, and shall supply such BMS Study Drug as either commercially labeled or unlabeled vials to the Recipient or its designee for use solely in the Combined Therapy Clinical Trial. The Recipient will at its sole expense, package and label the BMS Study Drug for use in the Combined Therapy Clinical Trial to the extent necessary. The cost of Manufacture and supply (including shipping, taxes and duty, if applicable) of the BMS Study Drug for the Combined Therapy Clinical Trial shall be borne solely by BMS, and BMS shall bear the risk of loss for such quantities of BMS Study Drug until delivery of such quantities of BMS Study Drug to the Recipient or its designee. BMS shall also be responsible for the payment of any Third Party License Payments that may be due based on the manufacture, *CONFIDENTIAL TREATMENT REQUESTED. supply and use of the BMS Study Drug used in the Combined Therapy Clinical Trial. The BMS Study Drug shall be manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Study Drug used by BMS for its other clinical trials of the BMS Study Drug. BMS shall deliver certificates of analysis, and any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to allow the Recipient to compare the BMS Study Drug certificate of analysis to the BMS Study Drug specifications. Pursuant to the Supply and Quality Documentation, BMS shall be responsible for the regulatory compliance of the quality of the BMS Study Drug at the time the BMS Study Drug is delivered to the Recipient with the regulatory filings in the countries in the Territory where the Combined Therapy Clinical Trial will be performed. Subject to Section 4.4, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Study Drug in connection with this Agreement.

  • 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:

  • 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.

Time is Money Join Law Insider Premium to draft better contracts faster.