Manufacture by Hutchmed Sample Clauses

Manufacture by Hutchmed. Following Manufacturing Technology Transfer Completion, Hutchmed shall be responsible for producing, at its sole expense, Drug Substance and Drug Product, including labeling and packaging activities, for Development and Commercial use in the Field and in the Territory. Hutchmed shall only be permitted to Manufacture Drug Substance itself or through a Permitted Subcontractor CMO or Drug Product itself. Hutchmed shall conduct such Manufacturing in compliance with GMP and all Applicable Laws. Following Manufacturing Technology Transfer Completion, the Clinical Supply Agreement and Commercial Supply Agreement, if any, shall terminate, and Epizyme shall have no further obligation to supply Drug Substance or Drug Product for Development or Commercial use by Hutchmed. Epizyme shall have the right, at Epizyme’s sole cost and expense, no more than [**] or more frequently if Epizyme has reason to believe (as demonstrated by reasonable evidence and provided to Hutchmed) that Hutchmed is in material breach of its obligations under this Agreement relating to Manufacturing, at any time upon reasonable advance notice of no less than [**], to inspect Hutchmed’s or the applicable Permitted Subcontractor CMO’s facilities in which Drug Substance or Drug Product are Manufactured.
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Related to Manufacture by Hutchmed

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  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

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