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

  • No update or amendment to the CMC Plan included in the GDP shall become effective unless and until the JDC approves a corresponding update or amendment to the Development Budget, if needed.

  • Each Party shall use its Commercially Reasonable Efforts to undertake and manage its responsibilities under the CMC Plan.

  • As contemplated under Section 2.2, the JDC shall oversee CMC Development and the establishment of Manufacturing sources and Licensed Product supply chains pursuant to the CMC Plan, subject to the provisions of this ARTICLE 8.

  • The Parties or the JDC may propose and prepare updates and amendments to the CMC Plan included in the GDP from time to time in accordance with Section 5.1.3. If the JDC approves an update or amendment to the CMC Plan included in the GDP (including any corresponding update or amendment to the Development Budget, if needed), the CMC Plan (and the Development Budget) shall be deemed to be amended accordingly on the date of such approval.

  • The GDP shall include the Development Budget, Registration Plan, Development Budget Forecast, and CMC Plan, as described below.

  • The costs associated with implementing the activities set forth in the CMC Plan shall be included in the Development Budget as Development Costs.

  • The CMC Plan shall include: (i) a mutually agreed upon approach between the Parties to minimize the cost of Manufacturing; (ii) certain studies related to CMC; and (iii) Chiesi’s right to participate in the audits conducted by Xxxxxxxx of all Third Party manufacturers that supply to Chiesi Licensed Product for clinical use in PAH and PH-ILD and all commercial use.


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 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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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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Related to CMC Plan

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

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

  • 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/).

  • 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.

  • 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 4.11(f).

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

  • 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.