MPC Product definition

MPC Product means a pharmaceutical product containing a population of MPCs in a final packaged form and labeled for use in clinical trials or for commercial purposes in accordance with the applicable Specifications and legal requirements in the Territory.

Split View

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Get StartedSchedule a Demo

MPC Product means a pharmaceutical or medicinal product containing MPCs as the intended therapeutic agent, including without limitation such a product in a final packaged form and labeled for use in clinical trials or for commercial sale to end users. 1.64 “MSC Product” means CLIENT’s remestemcel-L product (Ryoncil) for treatment of steroid-refractory acute graft versus host disease in pediatric patients. 1.65 “Non-binding Portion” has the meaning set forth in Section 7.2. 1.66 “Permitted Recipients” has the meaning set forth in Section 10.4. 1.67 [***]. 1.68 “Process” has the meaning set forth in Section 4.1. 1.69 “Product” means, individually, as applicable (a) MSC Product, (b) MPC Product in the event of the execution of a respective SOW for MPC Product, or (c) a cell bank for either the MPC Product or MSC Product upon execution of a respective SOW for manufacturing of a cell bank for either the MPC Product or MSC Product, as specified from time to time. For the avoidance of doubt, certain provisions of this Agreement do not apply to cell banks and such provisions will also be set forth in an SOW, including but not limited to portions of Sections 5.4, 5.5, and 6.2.2. 1.70 “Production Schedule” has the meaning set forth in Section 7.3. 1.71 “Product Warranties” has the meaning set forth in Section 6.1. 1.72 “Project Documentation” means the compilation of documentation generated by LONZA in preparation of and during the performance of a given SOW and any documentation to be provided to CLIENT pursuant to an SOW. 1.73 “Purchase Order” has the meaning set forth in Section 7.4. 1.74 “Quality Agreement” has the meaning set forth in Section 5.7. 1.75 “Reasonable Commercial Efforts” means, with respect to a Party, [***] As appropriate consistent with the foregoing, Reasonable Commercial Efforts shall require the applicable Party to: [***]. 1.76 “Regulatory Approval” means, with respect to a Product and any jurisdiction in the Territory, receipt of all approvals, licenses, registrations or authorizations from applicable Regulatory Authorities necessary to market and sell such Product in the particular jurisdiction in the Territory, as applicable. 1.77 “Regulatory Authority” means any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the development, manufacture or commercialization (including approval of

Examples of MPC Product in a sentence

• Angioblast and its Affiliates and licensees shall promptly notify Cephalon in the event it or its Affiliate or licensee has reason to believe that any such MPC Product sold or otherwise distributed has been or will be used in the Field.

• The costs of the independent third party expert shall be borne by the Party whose assessment of whether the proposed product is a STRO-1 MPC Product is incorrect.

• For clarification, the exception described in this clause (C) includes line extensions, modifications and changes to products where such product is a STRO-1 MPC Product as of the the Agreement Date, but does not extend to a modification or change after the Agreement Date that causes a product to become a STRO-1 MPC Product if such product is not a STRO-1 MPC Product as of the Agreement Date.

• The Parties, coordinating through the JSC, shall maintain and update a list of products that are STRO-1 MPC Products (the “STRO-1 MPC Product List”) and shall regularly discuss products that may be STRO-1 MPC Products for inclusion on such list.

• If the Parties agree (or both Parties’ representatives on the JSC agree) that such proposed product is a STRO-1 MPC Product, then such product shall then be added to ▇▇▇ ▇▇▇▇-1 MPC Product List.

• At the first JSC meeting, the JSC shall discuss products for inclusion on ▇▇▇ ▇▇▇▇-1 MPC Product List, and shall prepare at such meeting an initial STRO-1 MPC Product List that contains all products that have been mutually agreed by the Parties to be STRO-1 MPC Products.

• Either Party may propose, at a JSC meeting or by written notice, that a product, which the proposing Party believes is a STRO-1 MPC Product, be added to ▇▇▇ ▇▇▇▇-1 MPC Product List.

• At the first JSC meeting, the JSC shall discuss products for inclusion on t▇▇ ▇▇▇▇-1 MPC Product List, and shall prepare at such meeting an initial STRO-1 MPC Product List that contains all products that have been mutually agreed by the Parties to be STRO-1 MPC Products.

• Either Party may propose, at a JSC meeting or by written notice, that a product, which the proposing Party believes is a STRO-1 MPC Product, be added to t▇▇ ▇▇▇▇-1 MPC Product List.

• If the Parties agree (or both Parties’ representatives on the JSC agree) that such proposed product is a STRO-1 MPC Product, then such product shall then be added to t▇▇ ▇▇▇▇-1 MPC Product List.