Approved CMO definition

Approved CMO has the meaning set forth in Section 3.3.3(b)(8).
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Approved CMO has the meaning set forth in Section 6.8.
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Approved CMO shall have the meaning set forth in Section 5.2 (Transition of Supply).
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Examples of Approved CMO in a sentence

  • In any event, Kite shall cooperate to provide to Amgen (or to such Approved CMO under obligations of confidentiality) all existing manufacturing information then in Kite’s possession and control and reasonably required for Amgen (or such Third Party) to perform such transitioned manufacturing of Amgen Products.

  • Notwithstanding anything to the contrary in the License Agreement, nothing in the License Agreement shall require Vaxcyte to provide Sutro notice or obtain Sutro’s consent (or otherwise restrict Vaxcyte’s rights) in respect of the exercise of the Manufacturing Rights under (and in accordance with the terms of) this Agreement (including the Manufacture of Extract and [***] by an Approved CMO).

  • Notwithstanding anything in this Agreement to the contrary, LGC’s CMC information may only be shared with an Approved CMO.

  • Amgen shall be responsible for all costs associated with the transition to Amgen (or to such Approved CMO) (including payment at the FTE Rate for hours of consulting support provided by Kite).

  • The Parties hereby agree that each Existing CMO is deemed to be an Approved CMO solely for performance of Manufacturing of Licensed Products and Components, as the case may be, within the scope of the applicable Existing CMO Agreement.

  • Using the inputs described above, SPP performs a capacity adequacy analysis for the upcoming Operating Day using the SCUC algorithm.

  • Each sublicense granted to an Approved CMO or Approved Contractor pursuant to this Section 2.3(b) shall be granted pursuant to a written agreement between the Approved CMO or Approved Contractor and Vaxcyte that [***].

  • MTEM will not materially change any agreement with an Approved CMO as it relates to Supply, including any change to the criteria agreed upon by the Parties through the Joint Manufacturing Committee to which Supply should conform to be considered acceptable for its intended use, except in accordance with the Quality Agreement and otherwise subject to agreement of the Joint Manufacturing Committee.

  • Upon Vaxcyte’s reasonable request, made no earlier than [***] and no later than [***], Sutro shall support and cooperate with Vaxcyte to conduct an additional Tech Transfer to Vaxcyte, or an Affiliate of Vaxcyte or an Approved CMO designated by Vaxcyte, in a manner sufficient for Vaxcyte to fully exercise the Manufacturing Rights at the facilities of such designated recipient (the “Second Tech Transfer”).

  • Kite shall also, in connection therewith, grant to such Approved CMO a non-exclusive license to use such manufacturing technology solely for the purposes of performing the transitioned manufacturing of Amgen Products for Amgen.


More Definitions of Approved CMO

Approved CMO means (A) the CMOs set forth on Schedule 2.15.1 to the Supply Agreement, (B) [***], and (C) any other CMO proposed by Vaxcyte and approved by Sutro (such approval not to be unreasonably withheld, conditioned or delayed).
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Approved CMO means (a) those certain contract manufacturing organizations with which Denali has an agreement for the manufacture of Licensed Compounds or Licensed Products as of the Effective Date and (b) any other contract manufacturing organization approved in writing by Biogen, which approval shall not be unreasonably withheld, conditioned or delayed.
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Approved CMO means a contract manufacturing organization approved in writing by Kite (which approval shall not be unreasonably withheld, conditioned or delayed) to receive Kite Know-How in order to perform manufacturing services for DS or its Affiliates.
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Related to Approved CMO

  • Approved Commercial Bank means a commercial bank with a consolidated combined capital and surplus of at least $5,000,000,000.

  • Approved Vendor means a person who has been approved for inclusion on an approved vendor list through the approved vendor list process.

  • Approved Device means a device described in Subsection 20A-21-201(4) used to

  • Approved company means a company approved by the Minister under clause 17A(1)”;

  • Approved Contractor means an “Approved Contractor” specified in the Key Details.

  • Approved List means Securities followed by the Global Fundamental Research Group and tracked on the Approved List. Securities may be added, removed, or undergo periodic ratings changes.

  • approved facility means any private practice, hospital, clinic or other health facility in Namibia defined in section 1 of the Hospitals and Health Facilities Act, 1994 (Act No. 36 of 1994), approved by the Council for the purpose of the training of hearing aid acoustics interns, and “facility” has a corresponding meaning;

  • Approved costs means the eligible costs or expenditures2 as approved by the Provider, and as defined in the Agreement or Decision on Grant Funding to carry out the Grant Project.

  • Approved Entity means a body corporate that is incorporated or established under the laws of an OECD member state and which, on the occurrence of the Relevant Event, has in issue Relevant Shares.

  • Approved Foreign Bank has the meaning specified in the definition of “Cash Equivalents.”

  • Approved Valuer means a firm of valuers recognized as such by the Income Tax Department and having experience of valuing at least 5 (five) properties exceeding Rs. 100 cr. (Rupees one hundred crore) each in value;

  • Approved Source means Cisco or a Cisco authorized reseller, distributor or systems integrator.

  • Approved Vendor List means a list of approved vendors established under Section 63G-6a-507.

  • approved person means, in respect of a member (Member) of the Investment Industry Regulatory Organization of Canada (IIROC), an individual who is a partner, director, officer, employee or agent of a Member who is approved by IIROC or another Canadian SRO to perform any function required under any IIROC or other Canadian SRO by-law, rule, or policy;

  • VA Approved Lender means a lender which is approved by the VA to act as a lender in connection with the origination of VA Loans.

  • approved body means an educational establishment or a body that is not conducted for profit.

  • Approved Lender is defined in Section 12.1.

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • Approved/Approval means the approval in writing.

  • CAISO Approved Meter means any revenue quality, electric energy measurement meter furnished by Seller, that (a) is designed, manufactured and installed in accordance with the CAISO’s metering requirements, or, to the extent that the CAISO’s metering requirements do not apply, Prudent Electrical Practices, and (b) includes all of the associated metering transformers and related appurtenances that are required in order to measure the net electric energy output from the Generating Facility.

  • Approved program or "approved state" means a state or interstate program that has been approved or authorized by EPA under 40 CFR Part 123 (2000).

  • Scheduled Commercial Bank means any bank included in the second Schedule to the Reserve Bank of India Act, 1934 (2 of 1934).

  • Approved Flag means the Xxxxxxxx Islands flag, the Liberian flag, the Panama flag or any other flag which the Agent may approve as the flag on which a Ship may be registered;

  • Approved Manager means, in relation to each Ship, Allseas Marine S.A. a corporation organised and existing under the laws of the Republic of Liberia, having its registered office at 00 Xxxxx Xxxxxx, Xxxxxxxx, Xxxxxxx and maintaining a ship management office at Voula Center, Xxxxxxxx Xxxxxx Xxxxxx 000-000, 000 00 Xxxxx, Xxxxxx or any other company which the Agent may, with the authorisation of the Majority Lenders, approve from time to time as the technical and/or commercial manager of a Ship;

  • approved proposal means a proposal approved or deemed to be approved under this Agreement;

  • approved blood scheme means a scheme established or approved by the Secretary of State, or trust established with funds provided by the Secretary of State, for the purpose of providing compensation in respect of a person having been infected from contaminated blood products;