Common use of Post Validation Clause in Contracts

Post Validation. This phase begins after the completion of process validation through completion and approval of Corium’s process validation report for AG200-15 (for all, steps of the commercial manufacturing process except for the [*] validation on CL-4). During this initial commercial production phase Agile agrees to purchase at a minimum annual rate of [*] AG200-15 patches. As used herein, patch quantity includes all patch production from a production lot, including salable and non-salable (e.g. sample, demonstrator) patches. In the event that Agile orders fewer patches than the minimum [*], Agile will pay “Idle Facility Charges” (IFC) based on Building 51 “Facility Costs” (FC) incurred during such calendar quarter (see calculation below). Facilities costs will be pro-rated against the calculation below for any partial calendar quarter. As used herein, Facility Costs are defined as fully allocated Building 51 facility and operations costs related to preparing for and manufacturing of the AG200-15 product (including [*]). At the end of each quarter, Corium will invoice Agile for IFC and provide a detailed breakdown of the Facility Costs for the period in question. Agile shall pay IFC amounts within [*] after receipt of such notice from Corium. Idle Facility Charges will be calculated as follows: Quarterly orders >[*]patches per quarter, no IFC Quarterly orders > [*] patches per quarter to < [*] patches per quarter, IFC calculated as follows: [*] Quarterly orders < [*]M patches per quarter, payment of full IFC as defined in 3a.

Post Validation. This phase begins after the completion of process validation through completion and approval of Corium’s process validation report for AG200-15 (for all, steps of the commercial manufacturing process except for the [*] validation on CL-4). During this initial commercial production phase Agile agrees to purchase at a minimum annual rate of [*] AG200-15 patches. As used herein, patch quantity includes all patch production from a production lot, including salable and non-salable (e.g. sample, demonstrator) patches. In the event that Agile orders fewer patches than the minimum [*], Agile will pay “Idle Facility Charges” (IFC) based on Building 51 “Facility Costs” (FC) incurred during such calendar quarter (see calculation below). Facilities costs will be pro-rated against the calculation below for any partial calendar quarter. As used herein, Facility Costs are defined as fully allocated Building 51 facility and operations costs related to preparing for and manufacturing of the AG200-15 product (including [*]). At the end of each quarter, Corium will invoice Agile for IFC and provide a detailed breakdown of the Facility Costs for the period in question. Agile shall pay IFC amounts within [*] after receipt of such notice from Corium. Idle Facility Charges will be calculated as follows: Quarterly orders >[*]] patches per quarter, no IFC Quarterly orders > [*] patches per quarter to < [*] patches per quarter, IFC calculated as follows: [*] Quarterly orders < [*]M ] patches per quarter, payment of full IFC as defined in 3a.