Transition of Manufacturing Responsibilities to Cubist Sample Clauses

Transition of Manufacturing Responsibilities to Cubist. The Parties contemplate that, at a suitable time after the Effective Date, the Parties may agree to transfer responsibility for Manufacturing API Bulk Drug Substance and Finished Product for the Territory (as applicable) to Cubist or a designated Third Party manufacturer. The Supply Agreement Term Sheet also contains provisions under which Cubist may assume responsibility for the Manufacture of Licensed Product.
Sample 1
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Transition of Manufacturing Responsibilities to Cubist. (a) The Parties contemplate that, at a suitable time after the Effective Date, the Parties may agree to transfer responsibility for Manufacturing API Bulk Drug Substance and Finished Product for the Territory (as applicable) to Cubist or a designated Third Party manufacturer. The Supply Agreement Term Sheet also contains provisions under which Cubist may assume responsibility for the Manufacture of Licensed Product. (b) If, and at such time as a transition of Manufacturing to Cubist is to occur under Section 6.2(a), Cubist will either (i) enter into agreement(s) with API Bulk Drug Substance supplier(s) or Finished Product suppliers or (ii) supply API Bulk Drug Substance or Finished Product (after completion of transfer of responsibilities), in either case to replace the agreement(s) referenced in Section 6.1 or to provide a second source of supply for API Bulk Drug Substance or Finished Product, the terms of any such agreements or arrangements involving Cubist shall be subject to both Parties’ prior written approval, which approval shall not be unreasonably withheld or delayed. After such transition, Cubist’s Cost of Goods Sold for API Bulk Drug Substance and Finished Product (as applicable) supplied by Cubist for Development in the Profit-Share Territory shall be included as Development Costs, and Cubist’s Cost of Goods Sold for API Bulk Drug Substance and Finished Product (as applicable) supplied by Cubist for Commercialization in the Profit-Share Territory shall be shared by the Parties through the calculation of N.A. Pre-Tax Profit or Loss. (c) From and after such time, if any, as responsibility for Manufacturing API Bulk Drug Substance or Finished Product is transitioned to Cubist, Cubist shall use Diligent Efforts to Manufacture or have Manufactured and supply sufficient quantities of the API Bulk Drug Substance or Finished Product (as applicable) to enable Cubist to respond on a timely basis to customer demand for Licensed Products in the Field in the Territory. (d) Cubist acknowledges that Alnylam has certain supply obligations to Kyowa Hakko under the Kyowa Agreement, and that, if any such obligations to Kyowa Hakko or to another Asian Partner remain at the time of any transition of responsibility for supply to Cubist pursuant to Section 6.2(a), the Parties shall use Diligent Efforts to structure such transition in a manner that enables Alnylam to satisfy such supply obligations to Kyowa Hakko (or another Asian Partner, as applicable) after such t...
Sample 1

Related to Transition of Manufacturing Responsibilities to Cubist

  • Licensee Responsibilities Licensee is responsible for Licensee’s Users’ compliance with this Agreement. Licensee is responsible for all of Licensee’s uses and accounts. Licensee will be responsible for maintaining the security of Licensee’s accounts, passwords and files. Licensee and Users cannot share Licensee’s accounts or passwords or allow any third party to use Licensee’s accounts or passwords. Licensee will exercise reasonable precautions to prevent unauthorized use of the Software.

  • Licensee’s Responsibilities Licensee will be responsible for any and all damage to or relocation of existing facilities. Further, Licensee shall reimburse the City for all costs of replacing or repairing any property of the City, or of others, that is damaged by or on behalf of Licensee as a result of activities under this Agreement.

  • Contractor Responsibility for System Agency’s Termination Costs If the System Agency terminates the Contract for cause, the Contractor shall be responsible to the System Agency for all costs incurred by the System Agency and the State of Texas to replace the Contractor. These costs include, but are not limited to, the costs of procuring a substitute vendor and the cost of any claim or litigation attributable to Contractor’s failure to perform any Work in accordance with the terms of the Contract.

  • Client’s Responsibilities (a) Client agrees to advise Consultant regarding Client's Project requirements and to provide all relevant information, surveys, data and previous reports accessible to Client which Consultant may reasonably require. (b) Client shall designate a Project Representative to whom all communications from Consultant shall be directed and who shall have limited administrative authority on behalf of Client to receive and transmit information and make decisions with respect to the Project. Said representative shall not, however, have authority to bind Client as to matters of governmental policy or fiscal policy, nor to contract for additions or obligations exceeding a value which is the lesser of $5000 or 5% of the maximum contract price. (c) Client shall examine all documents presented by Consultant, and render decisions pertaining thereto within a reasonable time. The Client's approval of any drawings, specifications, reports, documents or other materials or product furnished hereunder shall not in any way relieve Consultant of responsibility for the professional adequacy of its work. (d) Client shall perform its obligations and render decisions within a reasonable time under the circumstances presented. Based upon the nature of Client and its requirements, a period of 14 days shall be presumed reasonable for any decision not involving policy decision or significant financial impact, when all information reasonably necessary for Client to responsibly render a decision has been furnished. A period of 46 days shall be presumed reasonable for Client to act with respect to any matter involving policy or significant financial impact. The above periods of presumed reasonableness shall be extended where information reasonably required is not within the custody or control of Client but must be procured from others.

  • Grantee Responsibility for System Agency’s Termination Costs If the System Agency terminates the Grant Agreement for cause, the Grantee shall be responsible to the System Agency for all costs incurred by the System Agency and the State of Texas to replace the Grantee. These costs include, but are not limited to, the costs of procuring a substitute grantee and the cost of any claim or litigation attributable to Xxxxxxx’s failure to perform any work in accordance with the terms of the Grant Agreement.

  • 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.

  • Patent Filing Responsibilities and Costs 1. The invention and patent rights herein apply to any patent application or patents covering an invention made under this Agreement. Each Party is responsible for its own costs of obtaining and maintaining patents covering sole inventions of its employees. The Parties may agree otherwise, upon the reporting of any invention (sole or joint) or in any license granted. 2. Partner shall include the following in patent applications for an invention made jointly between NASA employees, its Related Entity employees and Partner employees: The invention described herein may be manufactured and used by or for the U.S. Government for U.S. Government purposes without the payment of royalties thereon or therefore.

  • Customer Responsibilities Notwithstanding the above, Customer agrees that except as provided by this DPA, Customer is responsible for its secure use of the Services, including securing its account authentication credentials, protecting the security of Customer Data when in transit to and from the Services and taking any appropriate steps to securely encrypt or backup any Customer Data uploaded to the Services.

  • Provider Responsibilities The Private Child-Caring Facility (PCC) (a.k.a., Provider) must comply with the following requirements:

  • Performing Agency Responsibility for System Agency’s Termination Costs If the System Agency terminates the Contract for cause, the Performing Agency shall be responsible to the System Agency for all costs incurred by the System Agency and the State of Texas to replace the Performing Agency. These costs include, but are not limited to, the costs of procuring a substitute vendor and the cost of any claim or litigation attributable to Performing Agency’s failure to perform any Work in accordance with the terms of the Contract.

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