Designated CMO definition

Designated CMO means any Third Party contract manufacturer mutually agreed upon by the Parties, such agreement not to be unreasonably withheld, conditioned, or delayed.
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Designated CMO means any CMO selected by Dicerna, its Affiliate or their Sublicensees as its primary manufacturer of Product for commercial sales.
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Designated CMO has the meaning set forth in Section 7.1.1(c)(ii) (Subsequent Manufacturing Technology Transfer).
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Examples of Designated CMO in a sentence

  • Subject to Section 4.3.4 (Sublicense and License Requirements), (a) NVS may sublicense its rights under Section 4.1.3 (Manufacturing License); and (b) HMI may license or sublicense its rights under clauses (i) and (iii) under Section 4.1.3 (Manufacturing License), in each of (a) and (b), to any Designated CMO.

  • In HMI’s agreement with each applicable Designated CMO, HMI shall ensure that (1) NVS has the same rights in respect of the Designated CMO that NVS has under Section 8.6.1 (Manufacturing Related Rights), (2) NVS is a Third Party beneficiary to all such agreements with the right to enforce provisions contained therein, and (3) NVS is permitted to order such Candidate or Product directly from the Designated CMO pursuant to the terms of such HMI-Designated CMO agreement.

  • The Parties’ regulatory teams will collaborate with respect to substantive correspondence in support of (a) that portion of Jointly-Agreed Regulatory Submissions related to any In-Vivo [***] Product; and (b) that portion of Regulatory Submissions related to Manufacturing by HMI or its Designated CMO of Candidates and Products, in the case of each of ((a) and (b)), excluding any portion of such correspondence that contains any data or information relating to any Other Components.

  • The Parties’ regulatory teams will collaborate with respect to substantive correspondence in support of (a) that portion of Jointly-Agreed Regulatory Submissions related to any In-Vivo SCD Product; and (b) that portion of Regulatory Submissions related to Manufacturing by HMI or its Designated CMO of Candidates and Products, in the case of each of ((a) and (b)), excluding any portion of such correspondence that contains any data or information relating to any Other Components.

  • In respect of GMP Batches, all MBRs and Executed Batch Records generated by Protiva or its Permitted Contractors for the Manufacture of Manufactured Product under this Agreement shall be made available by Protiva to Dicerna, its Affiliate, their Sublicensee, any Designated CMO and Secondary CMO, as applicable, in accordance with the Quality Agreement but shall remain the property and Confidential Information of Protiva.

Related to Designated CMO

  • Designated Center means a State Development and Redevelopment Plan Center as designated by the State Planning Commission such as urban, regional, town, village, or hamlet.

  • Designated Company means any Subsidiary or Affiliate that has been designated by the Administrator from time to time in its sole discretion as eligible to participate in the Plan. For purposes of the 423 Component, only the Company and its Subsidiaries may be Designated Companies, provided, however that at any given time, a Subsidiary that is a Designated Company under the 423 Component will not be a Designated Company under the Non-423 Component.

  • Designated caregiver has the meaning as set out in the Code. Disciplinary Action includes termination of this Agreement and suspension, expulsion and exclusion of the Student as those terms are defined in the Act. Fee means fees payable by the Parents to the School as per the Fee Schedule. Fee Schedule means the schedule of fees for Tuition, Accommodation and miscellaneous charges, which is available from the School on request and may be updated from time to time. Homestay has the meaning as set out in the Code.

  • Designated Contact means, the designated contact for the Bank in the Jurisdiction, as set out in Annex I of Part A of these EB Services Terms and Conditions (as may be amended from time to time);

  • Nondesignated country means a country other than the United States or a designated country. "Recovery Act designated country" means any of the following countries:

  • Designated crisis responder means a mental health

  • Designated country means any of the following countries:

  • Designated Contract Representative(s) means those individual(s) designated by the Contractor on the Pre-Work form during the Pre-Work Conference.

  • Designated chemical dependency specialist means a person

  • Designated CMT Telerate Page means the display on Moneyline Telerate, or any successor service, on the page designated on the face hereof or any other page as may replace that page on that service for the purpose of displaying Treasury Constant Maturities as reported in H.15(519). If no page is specified on the face hereof, the Designated CMT Telerate Page shall be 7052, for the most recent week.

  • Designated Individual has the meaning set forth in Section 10.3.A hereof.

  • Designated Entity shall have the same meaning provided in the Operating Agreement. Direct Assignment Facilities:

  • Authorized Employee means an employee of Processor who has a need to know or otherwise access Personal Data to enable Processor to perform their obligations under this Addendum or the Agreement.

  • Designated Employees means a person occupying any of the following position in the Company:

  • Designated Computer means the computers and the upgraded computers thereof installed in the offices of the Licensee.

  • Designated supervisor means the supervisor designated by the Superintendent of Schools or designee as the administrator’s supervisor.

  • Designated Group means - i) Black designated groups; ii) Black People; iii) Women; iv) people with disabilities or v) Small enterprise, as defined in Section 1 of National Small Enterprise Act, (102 of 1996)

  • Designated CMT Reuters Page means the display on Reuters, or any successor service, on the page designated on the face hereof or any other page as may replace that page on that service for the purpose of displaying Treasury Constant Maturities as reported in H.15(519). If no Reuters page is specified on the face hereof, the Designated CMT Reuters Page shall be FEDCMT, for the most recent week.

  • Designated recipient means a person chosen by a user using an online tool to administer digital assets of the user.

  • Drug-dependent person means a person who is using a

  • Participating Country’ means any country that the Association determines meets the requirements set forth in Section 10 of Resolution No. 183 of the Board of Governors of the Association, adopted on June 26, 1996; and ‘Participating Countries’ means, collectively, all such countries.”

  • Participating Orthotic Provider means an Orthotic Provider who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Participating manufacturer means that term as defined in the master settlement agreement.

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Designated Affiliate means the affiliates of the Corporation designated by the Committee for purposes of the Plan from time to time;

  • Nondesignated country end product means any end product that is not a U.S.-made end product or a designated country end product.