Executing CMO Agreements Sample Clauses

Executing CMO Agreements. In connection with Akcea’s selecting and engaging one or more CMOs under Section 3.8.2(a) above, the Parties will cooperate in good faith to negotiate and execute any agreements with CMOs for the Manufacture of Clinical Supplies as well as for the Manufacture of Commercial Supplies (each such agreement, a “Manufacturing Agreement”). As between Akcea and Isis, Akcea will enter into such Manufacturing Agreements with CMOs. The Manufacturing Agreements will include (1) a license from Isis to the CMO under the Isis Manufacturing Patents and Isis Manufacturing and Analytical Know-How to the extent necessary for such CMO to Manufacture Products in such Third Party’s own manufacturing facility (a “Manufacturing License”), which Isis agrees it shall grant to any such licensed CMO, or, at Akcea’s election, a sublicense from Akcea to the CMO and (2) provisions permitting Isis to elect to have such agreements assigned to Isis in the event of a termination of this Agreement. Absent any such assignment election, except as set forth in Section 3.8.2, Isis will have no obligations under such Manufacturing Agreements. Akcea will have the final decision-making authority regarding the terms of any such Manufacturing Agreement with a CMO. Prior to execution of any such Manufacturing Agreement, Akcea will provide a copy of any proposed Manufacturing Agreement to Isis for Isis’ review and will consider in good faith all comments and recommendations provided by Isis with respect to such Manufacturing Agreement. Akcea will provide Isis with a true and complete copy of any Manufacturing Agreement with a CMO within 30 days after the execution thereof. Akcea will be responsible for paying the amount charged by a CMO for the Manufacture of Clinical Supplies and Commercial Supplies. Cost Estimate of API Cost per Kilogram (in OOO’s) Based on actual costs for raw materials. Identify the number of dedicated FTEs required to support the manufacture of budgeted production volume. Divide fully burdened salaries for these FTEs by the budgeted production volume. These are the costs associated with supporting our manufacturing equipment such as calibration, service contracts, environmental monitoring, water testing, and cleaning. Divide the total costs in this category by the budgeted production volume.
View SourceView Similar (2)
Executing CMO Agreements. In connection with Biogen Idec’s selecting and engaging one or more CMOs under Section 1.5.2 above, the Parties will cooperate in good faith to negotiate and execute any agreements with CMOs for the Manufacture of Clinical Supplies as well as the toll Manufacture of Commercial Supplies (each such agreement, a “Manufacturing Agreement”). As between Biogen Idec and Isis, Biogen Idec will enter into such Manufacturing Agreements with CMOs. The Manufacturing Agreements will include (1) a license from Isis to [***] under the [***] to the extent necessary for [***] (a “Manufacturing License”), which Isis agrees it shall grant to [***], or, at Biogen Idec’s election, a sublicense from Biogen Idec to [***] and (2) [***]. Absent any such [***], except as set forth in this Section 1.5.3, Isis will have no obligations under such Manufacturing Agreements. Biogen Idec will have the final decision-making authority regarding [***]. Prior to execution of any such Manufacturing Agreement, Biogen Idec will provide a copy of any proposed Manufacturing Agreement to Isis for Isis’ review and will consider in good faith all comments and recommendations provided by Isis with respect to such Manufacturing Agreement. Biogen Idec will provide Isis with a true and complete copy of any Manufacturing Agreement with a CMO within 30 days after the execution thereof. Biogen Idec will be responsible for paying [***].
View Source
Executing CMO Agreements. In connection with selecting and engaging one or more CMOs under Section 1.5.1 above, the Parties will cooperate in good faith to negotiate and execute any agreements with CMOs for the Manufacture of Clinical Supplies as well as the toll Manufacture of Commercial Supplies (each such agreement, a “Manufacturing Agreement”). Isis will enter into Manufacturing Agreements with one or more CMOs for the Manufacture of Clinical Supplies and Biogen Idec will enter into Manufacturing Agreements with one or more CMOs for the Manufacture of Commercial Supplies. The Manufacturing Agreements will include (i) in the event Isis is the contracting Party, [***] a license from Isis to [***] under the [***] to the extent necessary for [***] (a “Manufacturing License”) and [***]; and (ii) if Biogen Idec is the contracting Party, [***]. Additionally, if Biogen Idec is the contracting Party for a Manufacturing Agreement, Isis will [***]. Neither Party will enter into any agreement with a CMO for the Manufacture of API or finished drug Product unless the terms of such agreement are reasonably acceptable to both Isis and Biogen Idec. Prior to execution of any such agreement, the contracting Party will provide a copy of any proposed Manufacturing Agreement to the non-contracting Party for such non-contracting Party’s review and approval and will consider in good faith all comments and recommendations provided by the non-contracting Party with respect to such Manufacturing Agreement; provided, however, that Isis will have the final decision-making authority regarding [***], and Biogen Idec will have the final decision-making authority regarding [***]. Each Party will provide the other Party with a true and complete copy of any Manufacturing Agreement with a CMO within 30 days after the execution thereof. Subject to Section 1.4.1, Biogen Idec will be responsible for paying [***]. If the Parties mutually agree to use any portion of Commercial Supplies for the CS3 Study and/or the CS4 Study, Isis and Biogen Idec will cooperate in good faith and mutually agree on an appropriate [***] (if any) from Isis to Biogen Idec for such Commercial Supplies, based on the premise that Biogen Idec is responsible for [***].
View Source

Related to Executing CMO Agreements

  • Acquisition Agreements If the Equipment is subject to any Acquisition Agreement, Lessee, as part of this lease, transfers and assigns to Lessor all of its rights, but none of its obligations (except for Lessee's obligation to pay for the Equipment conditioned upon Lessee's acceptance in accordance with Paragraph 6), in and to the Acquisition Agreement, including but not limited to the right to take title to the Equipment. Lessee shall indemnify and hold Lessor harmless in accordance with Paragraph 19 from any liability resulting from any Acquisition Agreement as well as liabilities resulting from any Acquisition Agreement Lessor is required to enter into on behalf of Lessee or with Lessee for purposes of this lease.

  • Consents Under Agreements The Company shall have obtained the consent or approval of each Person whose consent or approval shall be required under any Contract to which the Company or any of its Subsidiaries is a party, except those for which the failure to obtain such consent or approval, individually or in the aggregate, is not reasonably likely to have a Company Material Adverse Effect or is not reasonably likely to prevent or to materially burden or materially impair the ability of the Company to consummate the transactions contemplated by this Agreement.

  • Parties to Lock-Up Agreements The Company has furnished to the Underwriters a letter agreement in the form attached hereto as Exhibit A (the “Lock-up Agreement”) from each of the persons listed on Exhibit B. Such Exhibit B lists under an appropriate caption the directors and executive officers of the Company. If any additional persons shall become directors or executive officers of the Company prior to the end of the Company Lock-up Period (as defined below), the Company shall cause each such person, prior to or contemporaneously with their appointment or election as a director or executive officer of the Company, to execute and deliver to the Representatives a Lock-up Agreement.

  • Additional Agreements of the Parties A. PARTICIPATION IN MARKETING EVENTS AND PROVISION OF TECHNICAL ASSISTANCE: Representative(s) of the City shall be entitled to participate in GPEC's marketing events provided that such participation shall not be at GPEC's expense. When requested and appropriate, GPEC will use its best efforts to provide technical assistance and support to City economic development staff for business location prospects identified and qualified by the City and assist the City with presentations to the prospect in the City or their corporate location.

  • Sub-Agreements Party shall not assign, subcontract or subgrant the performance of this Agreement or any portion thereof to any other Party without the prior written approval of the State. Party shall be responsible and liable to the State for all acts or omissions of subcontractors and any other person performing work under this Agreement pursuant to an agreement with Party or any subcontractor.