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 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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Examples of Approved CMO in a sentence

  • Incyte shall be solely responsible, at its sole cost and expense, for Manufacturing from the Licensed Compound Bulk Drug Substance, itself or through an Approved CMO, [**] of the projected global commercial supply of the Licensed Compound Drug Product.

  • 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.

  • 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.

  • 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.

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

  • 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”).

  • Without limiting the generality of the foregoing, Sutro shall have no liability to Vaxcyte with respect to any losses to the extent arising from (A) implementation of any [***] by Vaxcyte or an Approved CMO (including [***]) on behalf of Vaxcyte, or (B) any claims of failure to supply, product quality or product liability arising from Extract Manufactured by Vaxcyte, its Affiliates or any Approved CMO (including [***]) pursuant to a direct contract between such Approved CMO and Vaxcyte or its Affiliates.

  • Describe the assignments and exercises that will be used to promote critical thinking, synthesis, and transfer Students utilize previous didactic and pre-clinical knowledge to provide care in diverse clinical environments to patients in underserved areas.


More Definitions of Approved CMO

Approved CMO shall have the meaning set forth in Section 5.2 (Transition of Supply).
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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 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 Equal means any equipment or material which, in the opinion of the Architect, is equal in quality, durability, appearance, strength, design, performance, physical dimensions, and arrangement to the equipment or material specified, and will function adequately in accordance with the general design.

  • 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 which, on the occurrence of the Takeover Event and thereafter, has in issue Approved Entity 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 Financial Institution means any bank approved by Exchange in accordance with its credit review procedures or policies;

  • CAISO-Approved Meter means a CAISO approved revenue quality meter or meters, CAISO approved data processing gateway or remote intelligence gateway, telemetering equipment and data acquisition services sufficient for monitoring, recording and reporting, in real time, all electric energy produced by the Generating Facility less Station Use.

  • 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).

  • 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;