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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.
Designated CMO means any CMO selected by Dicerna, its Affiliate or their Sublicensees as its primary manufacturer of Product for commercial sales.
Designated CMO has the meaning set forth in Section 7.1.1(c)(ii) (Subsequent Manufacturing Technology Transfer).

Examples of Designated CMO in a sentence

  • 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.

  • Notwithstanding NVS’ right to Manufacture Candidates and Products itself commencing on the NVS Manufacturing Date, NVS shall also be entitled, where the Parties have agreed that a Designated CMO is capable of Manufacturing or supplying such Candidate or Product and such Designated CMO becomes able to Manufacture or supply such Candidate or Product (1) [***] or (2) [***] to have such Candidate and Product Manufactured by such alternative Designated CMO.

  • 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.

  • 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.

  • 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.

  • The Designated CMO would operate on the basis of extended collective licensing and serve as a one-stop shop where licenses for the digital transmission right in all recordings could be secured in a single transaction at reasonable fees.The Designated CMO would be authorized to represent not only the digital transmission right in recordings of which at least one co-owner was a member but also rights in recordings of which no co-owner was a member.

  • 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 instances where no co-owner of a recording is a member of the Designated CMO, the non-member co-owners would have the same three-year window in which to claim royalty payments.In addition, in instances where no co-owner of a recording is a member of the Designated CMO, any co-owner of that recording may serve an opt-out notice on the Designated CMO.

  • The Designated CMO would distribute royalties to non- member co-owners for licensed digital transmissions of their recordings if the non-member co- owners claim their royalties within three years after the royalties accrue.

  • The rights of co-owners who are not members of the Designated CMO would be protected.

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 means a person who:

  • 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);

  • 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 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.

  • Authorized Employee means a municipal employee who is authorized by the Municipality to exercise a power or perform a duty in terms of this By-law or to inspect land and buildings in order to enforce compliance with this By-law, the land use scheme and Deed of Title; “consolidation”, in relation to land, means the merging of two or more adjacent land parcels into a single land parcel;

  • 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 11 of Resolution No. 194 of the Board of Governors of the Association, adopted on April 8, 1999; and ‘Participating Countries’ means, collectively, all such countries."; and (b) The second sentence of Section 5.01 is modified to read: "Except as the Borrower and the Association shall otherwise agree, no withdrawals shall be made: (a) on account of expenditures in the territories of any country which is not a Participating Country or for goods produced in, or services supplied from, such territories; or (b) for the purpose of any payment to persons or entities, or for any import of goods, if such payment or import, to the knowledge of the Association, is prohibited by a decision of the United Nations Security Council taken under Chapter VII of the Charter of the United Nations." Section 1.02. Unless the context otherwise requires, the several terms defined in the General Conditions and in the Preamble to this Agreement have the respective meanings therein set forth and the following additional terms have the following meanings:

  • 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;

  • Participating Retail Health Clinic means a Retail Health Clinic 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.

  • Participating Pharmacy means a pharmacy that has entered into a prescription drug plan agreement with the Pharmacy Benefit Manager listed on your identification card.

  • PCP means Primary Care Provider.