Drug Product Services Clause Samples
The 'Drug Product Services' clause defines the scope and nature of services related to the development, manufacture, or handling of pharmaceutical drug products under an agreement. Typically, this clause outlines the specific responsibilities of the service provider, such as formulation, testing, packaging, or regulatory support, and may detail timelines, quality standards, and deliverables. Its core function is to clearly allocate duties and expectations regarding drug product-related tasks, ensuring both parties understand their roles and reducing the risk of misunderstandings or disputes.
Drug Product Services. If Client requests or causes the cancellation or rescheduling of the manufacturing of any cGMP batch in any project that is to be performed as part of the Drug Product Services (whether in isolation or through termination of this Contract or the Project Proposal or as a result of any delay in supplying any approvals or other information or other breach of this Contract or the Project Proposal):
(i) between [***] and [***] days before the date that any API is scheduled for introduction into the manufacturing process pursuant to the Project Proposal (the “Start Date”) (for Sterile Lyophilisate or Sterile Liquid projects only), Client will pay to PSG [***]% of the fees quoted for the affected manufacturing Drug Product Services and the associated analytical support;
(ii) between [***] and [***] days before the Start Date, Client will pay to PSG [***]% of the fees quoted for the affected manufacturing Drug Product Services and the associated analytical support;
(iii) between [***] and [***] days before the Start Date, Client will pay to PSG [***]% of the fees quoted for the affected manufacturing Drug Product Services and the associated analytical support;
(iv) between [***] and [***] days before the Start Date, Client will pay to PSG [***]% of the fees quoted for the affected manufacturing Drug Product Services and the associated analytical support; or on or after the Start Date, Client will pay to PSG [***]% of the fees quoted for those manufacturing Drug Product Services performed by PSG and [***]% of the fees quoted for the manufacturing Drug Product Services which were not performed due to the cancellation or rescheduling and the associated analytical support.
Drug Product Services. PSG’s liability for any and all obligations as set out in Section 13 in relation to Drug Product Services (as defined in Schedule C) will not in the aggregate exceed [***]% of the fee payable for that part of the Drug Product Services that are being repeated or reimbursed as such part is set out in the Drug Product part of the Budget Summary of the Project Proposal, comprised of [***]