Manufacturing and Supply Responsibilities Sample Clauses

Manufacturing and Supply Responsibilities. Contemporaneously with the execution of the Restated License Agreement, the Amended and Restated Non-Commercial Supply Agreement, dated as of May 15, 2009, by and between the Parties, shall terminate and no longer be in effect. Upon the Restatement Effective Date, subject to the terms and conditions of this Agreement, Astellas shall have the exclusive right and responsibility to manufacture or have manufactured (including packaging) the Compound, the Material and the Products for both clinical use and commercial distribution in the Territory; except that [… * …] the Compound, the Material and the Products [… * …] the Territory [… * …]. For the avoidance of doubt, it is understood and agreed that: (i) Astellas shall [… * …]; (ii) XenoPort shall have no obligation to: (A) [… * …]; (B) [… * …]; or (C) [… * …]; (iii) Astellas shall [… * …]; and (iv) [… * …] with respect to the manufacture of the Compound and Products for distribution [… * …]. * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Sample 1
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Manufacturing and Supply Responsibilities. Schering shall be responsible for Manufacturing or having Manufactured all quantities of Highly Active Collaboration Compound, Schering Field NV Compound and Schering Viral Product necessary for its Development and Commercialization throughout the Territory, as well as all activities related to process development and scale-up of the manufacturing process, all at its sole costs and expense. Following the Effective Date and during the Research Term, PTC shall provide Schering on a quarterly basis, or reasonably promptly in response to Schering's written request, with any Know-How or other information related to synthesis methods for Highly Active Collaboration Compounds or Schering Field NV Compounds developed by or on behalf of PTC and Controlled by PTC, either prior to or during the Research Term.
Sample 1

Related to Manufacturing and Supply Responsibilities

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

  • Specific Responsibilities In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreement, the JSC shall in particular:

  • 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.

  • ALPS’ Responsibilities In connection with its performance of TA Web, ALPS shall:

  • Customer Responsibilities (a) The Customer agrees to (i) promptly notify the Bank of any change that the Customer wishes to make to Exhibit B, (ii) promptly notify the Bank if any information contained in the Customer Information Sheet becomes inaccurate or untrue and (iii) indemnify the Bank for any losses resulting from the Customer's failure to adhere to the provisions of Subsection (a) of this Section 11.

  • Development Responsibilities From and after the Effective Date, BMS shall assume sole responsibility for the Development of Compounds and Products in the Field in the Territory during the Term at its own cost and expense (including responsibility for all funding, resourcing and decision-making, subject to Sections 3.3 and 3.4), except with respect to the performance by Ambrx of the Research Program activities assigned to Ambrx pursuant to the Research Plan and as otherwise may be agreed upon by the Parties in writing. BMS, by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to Develop a Compound or Product in the Field in accordance with the Development Plan for the purpose of obtaining a Regulatory Approval in each Major Market. For clarity, it is understood and acknowledged that Diligent Efforts in the Development of Compounds and Products may include sequential implementation of Clinical Trials and/or intervals between Clinical Trials for data interpretation and clinical program planning and approval.

  • Regulatory Responsibilities Following the approval by the FDA of an ANDA, Xxxx shall be solely responsible, with Corium’s reasonable assistance, for maintaining the ANDA for the Product including any necessary periodic reporting requirements. Furthermore, Xxxx shall be responsible for all adverse event reporting as required by the Act. Xxxx agrees to perform these activities in conformance with cGMP, the ANDA specifications and the Act. Xxxx shall provide Corium with copies of all material correspondence from or to regulatory authorities in the Territory relating to the maintenance of the ANDA.

  • Contractor Responsibilities It shall be Tenant’s responsibility to cause each of Tenant’s contractors and subcontractors to:

  • Company Responsibilities The Company will undertake responsibilities as set forth below:

  • Monitoring Responsibilities The Custodian shall furnish annually to the Fund, during the month of June, information concerning the foreign sub-custodians employed by the Custodian. Such information shall be similar in kind and scope to that furnished to the Fund in connection with the initial approval of this Contract. In addition, the Custodian will promptly inform the Fund in the event that the Custodian learns of a material adverse change in the financial condition of a foreign sub-custodian or any material loss of the assets of the Fund or in the case of any foreign sub-custodian not the subject of an exemptive order from the Securities and Exchange Commission is notified by such foreign sub-custodian that there appears to be a substantial likelihood that its shareholders' equity will decline below $200 million (U.S. dollars or the equivalent thereof) or that its shareholders' equity has declined below $200 million (in each case computed in accordance with generally accepted U.S. accounting principles).

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