CMC Development Sample Clauses

CMC Development. The responsibility to perform CMC Development for each Licensed Product shall be allocated to Kite, except with respect to the Existing Product, Arcellx and Kite shall both have responsibility for CMC Development until completion of the Manufacturing Transfer to Kite of the Existing Product. Each Party shall participate, through its representatives on the MWG, in decision-making with regard to CMC Development activities for each Licensed Product and of associated Manufacturing processes, which activities shall be conducted in accordance with the approved GDP for such Licensed Product.
Sample 1
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CMC Development. Company shall have the sole responsibility for and sole authority with respect to CMC Development of all Fixed Dose Combination Products at its own cost.
Sample 1
CMC Development. Allocation of responsibility to perform CMC Development for the Licensed Products shall be set out in the GDP. Each Party shall participate, through its representatives on the JDC, JCMCS and JFS, in decision-making with regard to CMC Development activities related to e.g. new formulations or dosage forms for the Licensed Products and of associated Manufacturing processes, which activities shall be conducted in accordance with the Development Manufacturing and Supply Plans or Commercial Manufacturing and Supply Plans incorporated into the GDP or GCP (as applicable).
Sample 1
CMC Development. All Development relating to CMC (other than activities related to the active pharmaceutical ingredient (API) of the Licensed Products) required to be conducted to support obtaining and maintaining Regulatory Approval in the Licensee Territory for any Licensed Product in the Initial Indications that is the subject of the Initial Indications Development Plan, including all CMC activities related to all phases of Manufacturing the Licensed Product through and including the packaging of Licensed Product in the format determined by the JSC to be preferable for the Japanese market (such as aluminum blister packs) for Commercialization in the Licensee Territory (the “CMC Activities”) will be conducted by Cxxxxx in accordance with the Harmonization Principle and the CMC Work Plan. Any and all costs and expenses incurred in connection with the CMC Activities will be borne solely by Licensee, except for such costs and expenses incurred for CMC Activities the completion of which is a condition to issuance of Regulatory Approval by the MHLW for a Licensed Product in an Initial Indication in the Licensee Territory, which costs and expenses will be borne by Cxxxxx; provided, that with respect to any such costs and expenses borne by Licensee, [*].
Sample 1
CMC Development. Responsibility for performing CMC Development for each Licensed Antibody and Licensed Product (and each formulation and dosage form thereof) shall be allocated under the GDP, provided that until the Manufacturing Transfer to GSK for an Existing Antibody and Existing Product, CMC Development shall be allocated to Alector and, to the extent any ongoing CMC Development activities as of such Manufacturing Transfer are to be transferred to GSK the Manufacturing Technology Transfer Plan shall provide for a plan for the transfer of such CMC Development activities. Each Party shall participate, through its representatives on the JMC, in decision-making with regard to CMC Development activities related to new formulations or dosage forms for Licensed Products and of associated Manufacturing processes, which activities shall be conducted in accordance with the approved GDP.
Sample 1
CMC Development. Xxxxxxx shall have responsibility for managing all Collaboration Activities relating to the development of chemistry, manufacturing, and controls technology and associated Know-How for the Manufacture of Licensed Products, which activities for clarity do not include actual production and testing of clinical supplies, which Manufacturing activities are governed by Section 7.1
Sample 1
CMC Development. All Development relating to CMC required to be conducted to support obtaining and maintaining Regulatory Approval in the Kaken Territory for any Licensed Product in the Initial Indication that is the subject of the Initial Indication Development Plan, including all CMC activities related to all phases of Manufacturing the Licensed Product through and including the packaging of Licensed Product in the format determined by the JSC to be preferable for the Japanese market [***] for Commercialization in the Kaken Territory (the “CMC Activities”), will be conducted by CymaBay [***] in accordance with the Harmonization Principle and the CMC Work Plan. Any and all costs and expenses incurred in connection with the CMC Activities [***] that are specific to the Japan regulatory activities or Japan market will be borne solely by Xxxxx (and reimbursed to CymaBay by Kaken based on invoices submitted); provided, however, that [***]. With respect to any such costs and expenses borne by Kaken, if any of the data and related CMC information, that are generated by the CMC Activities paid for by Kaken, are later utilized by CymaBay or any of its licensees in the CymaBay Territory or outside the Field of Use in the Kaken Territory, then CymaBay will promptly notify Kaken of such utilization [***]. Costs and expenses payable to CymaBay by Kaken under this Section 3.6 shall be paid in Dollars pursuant to invoices provided to Kaken by CymaBay after the end of each Kaken Fiscal Quarter, due and payable by Kaken to CymaBay within [***] of Kaken’s receipt of such invoice.
Sample 1
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CMC Development. Allocation of responsibility to perform CMC Development for each Licensed Compound and Product (and each formulation and dosage form thereof) shall be allocated as determined by the JDC. Until Second Chain
Sample 1
CMC Development 
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Related to CMC Development

  • Staff Development ‌ The County and the Association agree that the County retains full authority to determine training needs, resources that can be made available, and the method of payment for training authorized by the County. Nothing in this subsection shall preclude the right of an employee to request specific training.

  • Joint Development If joint development is involved, the Recipient agrees to follow the latest edition of FTA Circular 7050.1, “Federal Transit Administration Guidance on Joint Development.”

  • Program Development NWESD agrees that priority in the development of new applications services by XXXXX shall be in accordance with the expressed direction of the XXXXX Board of Directors operating under their bylaws.

  • Curriculum Development This includes the analysis and coordination of textual materials; constant review of current literature in the field, some of which are selected for the college library collection, the preparation of selective, descriptive materials such as outlines and syllabi; conferring with other faculty and administration on curricular problems; and, the attendance and participation in inter and intra-college conferences and advisory committees.

  • Project Development a. Collaborate with COUNTY and project clients to identify requirements and develop a project Scope Statement. a. Develop a Work Breakdown Structure (WBS) for each project. b. Evaluate Scope Statement to develop a preliminary cost estimate and determinate whether project be vendor bid or be executed under a Job Order Contract (JOC).

  • Development Within twenty (20) Working Days after the Commencement Date and in accordance with paragraphs 3.10 to 3.12 (Amendment and Revision), the Contractor will prepare and deliver to the Authority for approval the full and final Security Plan which will be based on the draft Security Plan set out in Appendix B.

  • Career Development The City and the Union agree that employee career growth can be beneficial to both the City and the affected employee. As such, consistent with training needs identified by the City and the financial resources appropriated therefore by the City, the City shall provide educational and training opportunities for employee career growth. Each employee shall be responsible for utilizing those training and educational opportunities made available by the City or other institutions for the self- development effort needed to achieve personal career goals.

  • Research and Development (i) Advice and assistance in relation to research and development of Party B; (ii) Advice and assistance in strategic planning; and

  • Design Development An interim step in the design process. Design Development documents consist of plans, elevations, and other drawings and outline specifications. These documents will fix and illustrate the size and character of the entire project in its essentials as to kinds of materials, type of structure, grade elevations, sidewalks, utilities, roads, parking areas, mechanical and electrical systems, and such other work as may be required.

  • Skills Development The Company acknowledges the changing pace of technology in the electrical contracting industry and the need for employees to understand those changes and have the necessary skill requirements to keep the Company at the forefront of the industry. The Parties to this Agreement recognise that in order to increase the efficiency, productivity and competitiveness of the Company, a commitment to training and skill development is required. Accordingly, the parties commit themselves to: i) Developing a more highly skilled and flexible workforce. ii) Providing employees with career opportunities through appropriate training to acquire the additional skills as required by the Company. Taking into account; The current and future skill needs of the Company. The size, structure and nature of the Company. The need to develop vocational skills relevant to the Company and the Electrical Contracting Industry. Where, by agreement between the employee and employer, an employee undertakes training providing skills, which are not a company specific requirement, any time spent in the completion of this training shall be unpaid.

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