CMC Plan definition

CMC Plan means the plan attached to this Agreement as Exhibit 1.38 [[***]] as such plan may be amended by both Parties in accordance with Section 3.5.
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CMC Plan means, with respect to any Research Program, the written plan for CMC Development and Manufacturing activities in connection with such Research Program, as further described in Section 2.3.
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CMC Plan has the meaning set forth in Section 8.1.
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Examples of CMC Plan in a sentence

  • The Agency’s primary focus for the CMC Plan was updating prior sources of information utilized for the ZEC Plan as well as utilizing where appropriate publicly available reports and analyses that have become available since the ZES Plan.

  • Milestone payments are due as follows; $1,500,000 is due upon completion of the CMC Plan as reimbursements of costs incurred by the foreign entity, $1,000,000 will be due upon first commercial sale of the Product.

  • All members of L.A. Care’s CMC Plan are full benefit dual eligible (e.g. they receive both Medicare and Medicaid).

  • Either Party, directly or through its representatives on the JDC, may propose amendments to the CMC Plan from time to time as appropriate, including in light of changed circumstances.

  • Provided that, GCLC shall not be held liable for any delays or failure to perform if such delay or failure is caused by Artiva, its Affiliates and/or any third party appointed by Artiva participating in any part of the Research and CMC Plan, associated Projects or Work Orders under this Agreement.

  • Under this Agreement, GCLC will perform certain activities and provide specific Services relating to Merck Products directed against up to three Collaboration Targets, as set forth in the applicable Research and CMC Plan for each Merck Product.

  • In partial consideration for its receipt of the Merck Product Payments under Section 2.3, GCLC acknowledges its responsibility to perform the activities assigned to GCLC under the Research and CMC Plans, and agrees that its failure to perform such activities under a Research and CMC Plan or associated Projects and Work Orders under this Agreement, would constitute a material breach of this Agreement.

  • CMC Plan and Re-work Within twenty (20) days after the receipt of the Principal Compound hereunder, TOBIRA shall provide a CMC plan to TAKEDA which shall include, as a whole or part of the plan, a proposal that TOBIRA will, either itself or through a Third Party manufacturer, re-crystallize or re-purify a part of Principal Compound among from [*] under the cGMP conditions to conform to the FDA’s regulations for use in humans (hereinafter called the “Re-work”).

  • The Research and CMC Plan for the initial Merck Product is attached as Exhibit B-1.

  • In the event, however, that Schering exercises its rights in only a portion of the Territory as described herein, then Schering and BioMedicines will negotiate in good faith subsequent development activity and any revisions to the CMC Plan and/or to the Development Plan.


More Definitions of CMC Plan

CMC Plan means the CMC Development plan attached hereto as Schedule 1.60 as the same may be amended from time to time by the JDC pursuant to Section 2.3.2.
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CMC Plan has the meaning set forth in Section 7.2(c). 1.41 “CMC Plan Know-How” means all Inventions developed or invented during the Term by Biogen’s or its Affiliates’, licensees’, Sublicensees’ or Subcontractors’ employees, agents or independent contractors or any Persons contractually required to assign or license such Know- How to Biogen or any Affiliate of Biogen, either alone or jointly with Sangamo’s or its Affiliates’, licensees’, Sublicensees’ or Subcontractors’ employees, agents or independent contractors or any Persons contractually required to assign or license such Know-How to Sangamo or any Affiliate of Sangamo, in each case, in the performance of activities under a CMC Plan. 1.42 “CMC Plan Patent Rights” means any Patent Rights that Cover or otherwise claim CMC Plan Know-How. 1.43 “CMC Plan Technology” means all CMC Plan Know-How and CMC Plan Patent Rights. 1.44 “CMO” has the meaning set forth in Section 7.2(d) (Sangamo Supply Obligations). 1.45 “Collaboration Target” means (a) any Initial Target; or (b) any other Target that has been selected by Biogen as a “Collaboration Target” pursuant to Section 4.7(b) (Selection of Collaboration Targets) and is deemed a “Collaboration Target” pursuant to Section 4.7(c) (Notice of Target Nomination). 5 [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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CMC Plan means the CMC Development plan attached hereto as S chedule 1.60 as the same may be amended from time to time by the JDC pursuant to Section 2.3.2.
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Related to CMC Plan

  • EHC plan means an Education, Health and Care plan made under sections 37(2) of the Children and Families Act 2014.

  • RBC plan means a comprehensive financial plan containing the elements specified in K.S.A. 40-2c06, and amendments thereto. If the commissioner rejects the RBC plan, and it is revised by the insurer, with or without the commissioner's recommendation, the plan shall be called the "revised RBC plan."

  • Flexi Plan means any individual indemnity hospital insurance plan under the VHIS framework with enhancement(s) to any or all of the protections or terms and benefits that the Standard Plan provides to the Policy Holder and the Insured Person, subject to certification by the Government. Such plan shall not contain terms and benefits which are less favourable than those in the Standard Plan, save for the exception as may be approved by the Government from time to time.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • BCDR Plan means the plan consisting of general business continuity and disaster recovery principles, the Business Continuity Plan and Disaster Recovery Plan as further described in paragraph 1.2 of Schedule 2- 14.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • HACCP plan means a written document that delineates the formal procedures for following the hazard analysis and critical control point principles developed by the National Advisory Committee on Microbiological Criteria for Foods.

  • Supplemental Plan means a written plan for a child outlining the agency's plan to locate a permanent placement for the child and which may be developed concurrently with the case plan.

  • Profit Sharing Plan means a profit-sharing plan that is qualified pursuant to 26 U.S.C. § 401 of the Internal Revenue Code and subject to the Employee Retirement Income Security Act, and which provides for employer contributions in the form of cash, but not in the form of stock or other equity interests in a Medical Marijuana Business.

  • Basin plan means the same as “water quality control plan” as defined in Division 7 (commencing with Section 13000) of the Water Code. Basin Plans are adopted by each Regional Water Board, approved by the State Water Board and the Office of Administrative Law, and identify surface water and groundwater bodies within each Region’s boundaries and establish, for each, its respective beneficial uses and water quality objectives. Copies are available from the Regional Water Boards, electronically at each Regional Water Boards website, or at the State Water Board’s Plans and Policies web page (http://www.waterboards.ca.gov/plans_policies/).

  • Supply Plan has the meaning set forth in the CAISO Tariff.

  • Company Plan means any Benefit Plan: (i) under which any current or former director, officer, employee, consultant or independent contractor of the Company has any present or future right to benefits and that is maintained, sponsored or contributed to by the Company; or (ii) with respect to which the Company has any Liability.

  • Development Plan has the meaning set forth in Section 3.2.

  • Separation Plan means the Company’s Separation Plan Amended and Restated Effective August 13, 2006, as may be amended from time to time or any successor plan, program, arrangement or agreement thereto.

  • Transition Plan means a transition plan, acceptable to the LHIN that indicates how the needs of the HSP’s clients will be met following the termination of this Agreement and how the transition of the clients to new service providers will be effected in a timely manner; and

  • Plan means any employee pension benefit plan (other than a Multiemployer Plan) subject to the provisions of Title IV of ERISA or Section 412 of the Code or Section 302 of ERISA, and in respect of which the Borrower or any ERISA Affiliate is (or, if such plan were terminated, would under Section 4069 of ERISA be deemed to be) an “employer” as defined in Section 3(5) of ERISA.

  • Parent Plan means an Employee Benefit Plan sponsored, maintained, or contributed to by Parent or its Affiliates or with respect to which Parent or its Affiliates have any liability.

  • Super Top Heavy Plan means a plan described in Section 2.2(b).

  • Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.

  • Company 401(k) Plan shall have the meaning set forth in Section 6.09(e).

  • Welfare Plan means a “welfare plan” as defined in Section 3(1) of ERISA.

  • Basic health plan model plan means a health plan as required in RCW 70.47.060(2)(e).

  • Restoration Plan means all technical and organisational measures necessary for the restoration of the system back to normal state;

  • Project Implementation Plan means the detail plan submitted by the Developer with regard to development of Project Facilities and its operation and management thereof in accordance with this Agreement and to be appended as Schedule 9 to this Agreement.

  • Care Plan means a licensee's written description of a resident's needs, preferences, and capabilities, including by whom, when, and how often care and services are to be provided.