CMC Development Clause Samples

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 C▇▇▇▇▇ 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 C▇▇▇▇▇; provided, that with respect to any such costs and expenses borne by Licensee, [*].

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.

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 ▇▇▇▇▇ (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.

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

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).

CMC Development. ▇▇▇▇▇▇▇ 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

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.

CMC Development