CMC Activities Clause Samples

The "CMC Activities" clause defines the responsibilities and procedures related to Chemistry, Manufacturing, and Controls (CMC) activities within a contractual relationship, typically in the context of pharmaceutical development or manufacturing. This clause outlines which party is responsible for conducting, documenting, and reporting CMC activities, such as process development, quality control, and regulatory submissions. It may also specify timelines, standards, and the sharing of information or materials. The core function of this clause is to ensure that all CMC-related tasks are clearly assigned and managed, reducing the risk of misunderstandings and ensuring compliance with regulatory requirements.
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CMC Activities. AN▇▇▇▇▇▇ ▇hall be solely responsible for performing, at its sole cost, all activities required to support the chemistry, manufacturing and control requirements for the ANDA (“CMC”) as required to support the NDA or ANDA in the Territory. AN▇▇▇▇▇▇ ▇hall perform all activities, prepare all materials and information, and provide any and all equipment, as required for CMC to support the NDA or ANDA.
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CMC Activities. (a) The first sentence of Section 4.2 of the Agreement shall be deleted in its entirety and replaced with the following: “NN shall pay ZGEN the milestone fees set forth in Sections 4.2(a) through 4.2(d) and 4.2(i), subject to utilization of any credits provided in Sections 4.5(b) and 5.5.” (b) A new Section 3.12 shall be added to the Agreement as follows:
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CMC Activities. Notwithstanding anything herein to the contrary (but subject to the last two sentences of this Section 4.4), with respect to CMC responsibilities, (i) Loxo shall be responsible for ongoing CMC Activities related to the capsule or liquid formulation of a Licensed Product pursuant to the applicable Development Plan, (ii) Bayer shall be responsible for CMC Activities related to a tablet formulation of any LOXO-101 Product pursuant to the applicable Development Plan and, (iii) following the transition of Manufacturing and CMC Activities to Bayer as set forth in Section 10.1, Bayer shall be solely responsible for CMC Activities for Licensed Compounds and Licensed Products pursuant to the applicable Development Plan. For clarity, the provisions of Section 3.6.3 with respect to Loxo’s final decision-making authority shall not apply to CMC Activities following the transition of such activities to Bayer as set forth in Section 10.1. [***] 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 406 of the Securities Act of 1933, as amended. Confidential treatment has been requested with respect to this information. [***]
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CMC Activities. XOMA shall be responsible for the performance of CMC Activities for Bulk Drug Substance, including associated regulatory activities, in accordance with the Manufacturing Plan. Prior to XOMA’s exercise of the Cardiometabolic Indications Option and thereafter if XOMA does not exercise such option, Servier shall reimburse XOMA for all documented costs incurred by XOMA in performing such activities in accordance with the Manufacturing Plan and the budget contained therein, as provided in Article 3. If XOMA exercises the Cardiometabolic Indications Option, XOMA shall reimburse certain of these costs as provided in Section 8.5, and the Parties shall thereafter share such costs for the Cardiometabolic Field as provided in Section 3.4(d).
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CMC Activities. As part of winding-down the Studies and the manufacturing activities related thereto, Merck will discontinue all activities related to drug substance-, formulation- and analytical development of all Compounds and Follow-on Compounds. Discontinuing formulation development includes Merck’s short term stability studies after 9-months stability data become available from Alphalytik. Upon Idera´s request, and subject to Idera´s willingness to take on all subsequent costs and duties associated with such stability studies, Merck is willing to provide reasonable assistance to Idera to enable continuation of the ongoing stability studies beyond the 9-month timepoint. Idera will inform Merck within [**] days after the Effective Date if it wants to assume the responsibility of conducting the stability studies beyond 9 months. In any event, Merck shall not be liable to Idera for any failure of Idera to enter into a contract with Alphalytik. Furthermore, Merck´s assistance will be limited to reasonable efforts to establish contact and mediate a handover within [**] months following the Effective Date, but shall not include any continuation of technical activities such as laboratory work.
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CMC Activities. As of the Effective Date and during the first [***] years this Agreement is in effect, ISIS will support ATL's efforts to timely file an IND application for each Collaboration Compound with respect to the CMC activities described in Exhibit 9.1 for Collaboration Compounds for which ISIS supplied API.
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CMC Activities. NN shall use commercially reasonable efforts to perform the process development, implementation, qualification, validation, and process scale-up to clinical and commercial scale and any other activities required to develop and commercialize a Licensed Product, including, without limitation, production of the drug product (“Drug Product”) at anticipated commercial scale of, at least, [ * ] liters (“Commercial Scale Production”) and [ * ] stability studies of a new formulation of the Licensed Products produced at a lab scale under research (non-GMP) conditions (“New Formulation Stability Study”). (c) A new Section 4.2(i) shall be added to the Agreement as follows: (i) The milestone fees for CMC activities shall be as follows: U.S. $[ * ] First successful completion of the Commercial Scale Production. A Commercial Scale Production will be considered successful if it meets the success criteria outlined in the attached Exhibit J. U.S. $[ * ] First successful completion of New Formulation Stability Study. A New Formulation Stability Study will be considered successful if it meets the success criteria outlined in the attached Exhibit K. U.S. $[ * ] Due on [ * ] (not subject to Section 4.2(e)(iv)) For the avoidance of doubt, the Time Milestone in the table in Section 4.2(i) shall terminate if NN terminate the License Agreement for Recombinant Factor XIII. (d) A new Exhibit J shall be added to the Agreement in the form attached as Schedule 1. (e) A new Exhibit K shall be added to the Agreement in the form attached as Schedule 2.
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Related to CMC Activities

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection ▇▇▇▇▇; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Specific Activities Please give detailed information about the specific activities of the Project promoter and the Partner(s), with budget allocations 7.1 The main tasks of [name of the Project Promoter], referred to as the ‘Project Promoter’, are summarized as follows: Name Project activities Project budget 1 .... [mention the budget allocated to Project Promoter for the respective activity] EUR.... Activity 2 .... EUR... 7.2 The main input/responsibilities of [name of the Project Partner(s)], referred to as Partner 1, 2, etc., are summarized as follows: Name Project activities Project budget Partner 1... [briefly present the project activity implemented by Partner]. Activity 1 .... [mention the budget allocated to Partner 1 for the respective activity] EUR.... Activity 2 .... EUR... Name Project activities Project budget

  • Collaboration activities 4.1 The Collaboration Suppliers will perform the Collaboration Activities and all other obligations of this Agreement in accordance with the Detailed Collaboration Plan. 4.2 The Collaboration Suppliers will provide all additional cooperation and assistance as is reasonably required by the Buyer to ensure the continuous delivery of the services under the Call-Off Contract. 4.3 The Collaboration Suppliers will ensure that their respective subcontractors provide all cooperation and assistance as set out in the Detailed Collaboration Plan.

  • Regulatory Activities a) As between the Parties, Xynomic shall have the sole responsibility and discretion for preparing, obtaining, and maintaining Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions, and for conducting communications with the Regulatory Authorities, for Licensed Compounds or Licensed Products in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities). All Regulatory Approvals relating to the Licensed Compounds or Licensed Products with respect to the Territory shall be owned by, and shall be the sole property and held in the name of, Xynomic or its designated Affiliate. Pharmacyclics hereby assigns to Xynomic all of Pharmacyclics’ (or its Affiliates’) right, title, and interest in and to all Regulatory Documentation owned by Pharmacyclics (or its Affiliates) and held in Pharmacyclics’ name (or its Affiliates) as of the Effective Date or generated in the “winding up” activities after the Effective Date and shall deliver all Regulatory Documentation as well as embodiments of all Regulatory Documentation to Xynomic within sixty (60) days after the Effective Date. b) Xynomic shall notify the Pharmacyclics Alliance Manager promptly (but in no event later than forty-eight (48) hours) following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Licensed Compound or Licensed Product in the Territory, and shall include in such notice the reasoning behind such determination, and any supporting facts. Xynomic (or its Sublicensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Territory; provided that prior to any implementation of such a recall, market suspension, or market withdrawal, Xynomic shall consult with Pharmacyclics and shall consider Pharmacyclics’ comments in good faith. If a recall, market suspension, or market withdrawal is mandated by a Regulatory Authority in the Territory, Xynomic (or its Sublicensee) shall initiate such a recall, market suspension, or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions, or market withdrawals undertaken pursuant to this Section 2.2.1.b), Xynomic (or its Sublicensee) shall be solely responsible for the execution and all costs thereof.

  • PROJECT ACTIVITIES This Grant Agreement is for the Foundational Year only. Subsection 1. Continuous SIA Plan Implementation (a) Increasing instructional time, which may include: (A) More hours or days of instructional time; (B) Summer programs; (C) Before-school or after-school programs; or (D) Technological investments that minimize class time used for assessments administered to students. (b) Addressing students’ health or safety needs, which may include: (A) Social-emotional learning and development; (B) Student mental and behavioral health; (C) Improvements to teaching and learning practices or organizational structures that lead to better interpersonal relationships at the school; (D) Student health and wellness; (E) Trauma-informed practices; (F) School health professionals and assistants; or (G) Facility improvements directly related to improving student health or safety. (c) Reducing class sizes, which may include increasing the use of instructional assistants, by using evidence-based criteria to ensure appropriate student-teacher ratios or staff caseloads. (d) Expanding availability of and student participation in well-rounded learning experiences, which may include: (A) Developmentally appropriate and culturally responsive early literacy practices and programs in prekindergarten through third grade; (B) Culturally responsive practices and programs in grades six through eight, including learning, counseling and student support that is connected to colleges and careers; (C) Broadened curricular options at all grade levels, including access to: (i) Art, music and physical education classes; (ii) Science, technology, engineering and mathematics education;