CMC Plan definition

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 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 has the meaning set forth in Section 8.2.3 (CMC Plan).
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Examples of CMC Plan in a sentence

  • 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.

  • 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”).

  • Schering and BioMedicines also agree to discuss possible improvements to manufacturing and further agree to incorporate plans, if judged appropriate, for such possible improvements into the CMC Plan referred to in Section 4.1 above.

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

  • The CMC Plan may be modified from time to time as agreed by the JDC as further described above.

  • 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.

  • The purpose of the CMC Plan will be to identify those steps necessary or desirable for subsequent Development and necessary or desirable to obtain approval of the Licensed Product in the Territory.

  • 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.

  • As a master form of contract, this Agreement allows the parties to contract, with respect to each Research and CMC Plan, for multiple Projects through the issuance of multiple Work Orders, without having to re-negotiate the basic terms and conditions contained herein.

  • 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.


More Definitions of CMC Plan

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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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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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 has the meaning set forth in Section 3.2.