CMC Services Sample Clauses

The CMC Services clause defines the scope and nature of services provided by a Contract Manufacturing Company (CMC) under the agreement. It typically outlines the specific manufacturing, packaging, quality control, and related support activities the CMC will perform for the client, often including timelines, deliverables, and compliance requirements. By clearly delineating the responsibilities and expectations for both parties, this clause ensures that the manufacturing process meets agreed standards and helps prevent misunderstandings or disputes regarding service obligations.
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CMC Services. In accordance with the plan and budget set forth in Appendix 2, AbbVie shall (i) prepare comparability reports, suitable for filing with the FDA and EMA as applicable, relating to changes in the processes for manufacture of Drug Substance and Drug Product as supplied hereunder in comparison with processes employed by AbbVie under the existing IND for ABT-308 for Phase 1 and Phase 2 clinical supply prior to the Development Agreement Effective Date; and (ii) in the event that ***; and (iii) subject to mutual written agreement of the Parties ***, AbbVie shall perform formulation development services and related services in support of chemistry, manufacturing and controls all in preparation for a first Phase 3 trial ((i)-(iii) collectively, “CMC Services”). The JDC shall oversee the performance of the CMC Services.
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CMC Services. Following completion of the Development Plan Study, AbbVie shall continue to perform the CMC Services with respect to chemistry, manufacturing and controls with respect to Drug Substance and Drug Product and in support of any associated filings with applicable Regulatory Authorities until the expiration or termination of its obligations to perform the Additional Phase III Supply Services.
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CMC Services. Upon AstraZeneca’s reasonable request, Nektar shall use commercially reasonable efforts to provide any CMC services requested by AstraZeneca at Nektar’s [***], to the extent Nektar has the required expertise and experience, and provided that the Parties shall reasonably cooperate to minimize interference with Nektar’s other business commitments.
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CMC Services. ACEA shall use Commercially Reasonable Efforts to provide to Sorrento with Chemistry, Manufacturing and Controls (CMC) services, including CMC maintenance, CMC improvement and any other CMC-related services, sufficient to facilitate successful achievement of Regulatory Approval in the Territories, including but not limited to U.S., Europe and Japan, for the Licensed Products, including satisfaction of any and all applicable FDA and European Union registration requirements (collectively, the “CMC Services”). Without limiting the foregoing, the Parties will discuss in good faith and agree on a list of CMC Services, to include descriptions of the scope and details of such CMC Services, within a reasonable period of time after the Effective Date, which list will be attached hereto as Exhibit C and shall not be deemed to limit the foregoing obligations set forth in this Section 3.1(c). From time to time, the Parties may update Exhibit C by mutual written agreement. In consideration of the CMC Services and unless ACEA is in breach of its obligations under this Section 3.1(c), Sorrento will pay to ACEA a monthly fee of [...***...] (the “CMC Services Fee”) up to a total, aggregate amount of [...***...] (the “CMC Services Fee Cap”) during the term of this Agreement. For clarity, in the event that Sorrento has paid CMC Service Fees totalling the CMC Services Fee Cap in the aggregate, ACEA shall continue to provide and perform the CMC Services at no additional cost until Sorrento has successfully achieved Regulatory Approval in the U.S. and Europe for the Licensed Products, including satisfaction of any and all applicable FDA and European Union registration requirements
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Related to CMC Services

  • Pharmacy Services The Contractor agrees to comply with the requirements regarding covered pharmacy and over-the- counter (OTC) benefits. The Contractor will comply with the EOHHS Pharmacy Home Program and the Generics First Initiative, including the maintenance of the drug formulary in accordance with the direction of the EOHHS Pharmacy Committee.

  • Specific Services Contractor shall provide the services described in Exhibit “A” attached hereto. No additional services shall be performed by Contractor unless approved in advance in writing by the County stating the dollar value of the services, the method of payment, and any adjustment in contract time or other contract terms. All such services are to be coordinated with County and the results of the work shall be monitored by the Director of Health and Human Services Agency or his or her designee.

  • Diagnostic Services Procedures ordered by a recognized Provider because of specific symptoms to diagnose a specific condition or disease. Some examples include, but are not limited to:

  • Telemedicine Services This plan covers clinically appropriate telemedicine services when the service is provided via remote access through an on-line service or other interactive audio and video telecommunications system in accordance with R.I. General Law § 27-81-1. Clinically appropriate telemedicine services may be obtained from a network provider, and from our designated telemedicine service provider. When you seek telemedicine services from our designated telemedicine service provider, the amount you pay is listed in the Summary of Medical Benefits. When you receive a covered healthcare service from a network provider via remote access, the amount you pay depends on the covered healthcare service you receive, as indicated in the Summary of Medical Benefits. For information about telemedicine services, our designated telemedicine service provider, and how to access telemedicine services, please visit our website or contact our Customer Service Department.

  • Program Services a) Personalized Care Practice agrees to provide to Program Member certain enhancements and amenities to professional medical services to be rendered by Personalized Care Practice to Program Member, as further described in Schedule 1 to these Terms. Upon prior written notice to Program Member, Personalized Care Practice may add or modify the Program Services set forth in Schedule 1, as reasonably necessary, and subject to such additional fees and/or terms and conditions as may be reasonably necessary. b) Program Member acknowledges that the Program Services are services that are not covered services under any insurance contract to which Program Member may be a party, including, without limitation, Medicare, and are not reimbursable by Program Member’s insurer, health plan or any governmental entity, including Medicare. Program Member agrees to bear sole financial responsibility for the Member Amenities Fee and agrees not to submit to Program Member’s insurer, health plan or governmental entity any ▇▇▇▇, invoice or claim for payment or reimbursement of such Member Amenities Fee. c) Personalized Care Practice or its designated affiliate will separately charge Program Member or Program Member’s insurer, health plan or governmental entity for medical, clinical, diagnostic or therapeutic services rendered by Personalized Care Practice or its designated affiliate to Program Member, and Program Member may seek payment or reimbursement from Program Member’s insurer or health plan for any such service to the extent covered by Program Member’s insurer, health plan or governmental entity. d) Program Member understands, agrees and covenants that this Agreement is a service contract, and not a contract for insurance.