Common use of Program Definition Clause in Contracts

Program Definition. Hollister-Stier shall, in compliance with All Applicable Laws and Re▇▇▇▇▇▇▇▇▇, ▇▇▇▇y out the manufacturing program outlined in Exhibit 1 of this Agreement hereto including any modifications and additions thereto agreed upon by the Parties (" CTM Program") and in accordance with the Schedule as set forth in Exhibit 3 of this Agreement shall (i) confirm the Manufacturing Process, including the confirmation, qualification and validation activities as specified in Exhibit 1 and Exhibit 3 of this Agreement, (ii) confirm the Specifications for manufacturing the Intermediate and Product, (iii) manufacture Batches in accordance with the requirements set forth in Exhibit 1 of this Agreement, and (iv) confirm the analytical methodology used to test the Intermediate and Product for compliance with the Specifications in accordance with the acceptance criteria defined in analytical testing method transfer protocols developed in conjunction with the Client. Hollister-Stier agrees to work with Client to attempt to minimize th▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇elopment (Simulation) Batches required prior to the manufacturing of aseptic process validation and manufacturing of CTM Batches. The CTM Program shall identify all documentation (including regulatory documentation) and other deliverables to be provided by Hollister-Stier to Client pursuant to this Agreement and appended he▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇ 4 ("the Documentation") of this Agreement. Hollister-Stier shall use its commercially reasonable best efforts t▇ ▇▇▇▇▇▇▇▇ ▇▇▇ CTM Program in a timely fashion in accordance with the Schedule agreed upon by the Parties and set forth in Exhibit 3 of this Agreement. If Hollister-Stier is unable to complete any stage of the CTM Program i▇ ▇▇▇ ▇▇▇▇▇▇ ▇▇mes, it shall immediately notify Client, in writing, of the delay, and the reason therefor. Hollister-Stier shall negotiate with Client a mutually acceptable da▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇n for the respective stage of the CTM Program, and Hollister-Stier shall use its commercially reasonable best efforts t▇ ▇▇▇▇▇▇▇▇ ▇▇▇ CTM Program within such newly agreed upon time.

Program Definition. Hollister-Stier shall, in compliance with All Applicable Laws and Re▇▇▇▇▇▇▇▇▇, ▇▇▇▇y out the manufacturing program outlined in Exhibit 1 of this Agreement hereto including any modifications and additions thereto agreed upon by the Parties (" "CTM Program") and in accordance with the Schedule as set forth in Exhibit 3 of this Agreement shall (i) confirm the Manufacturing Process, including the confirmation, qualification and validation activities as specified in Exhibit 1 and Exhibit 3 of this Agreement, (ii) confirm the Specifications for manufacturing the Intermediate and Product, (iii) manufacture Batches in accordance with the requirements set forth in Exhibit 1 of this Agreement, and (iv) confirm the analytical methodology used to test the Intermediate and Product for compliance with the Specifications in accordance with the acceptance criteria defined in analytical testing method transfer protocols developed in conjunction with the Client. Hollister-Stier agrees to work with Client to attempt to minimize th▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇elopment (Simulation) Batches required prior to the manufacturing of aseptic process validation and manufacturing of CTM Batches. The CTM Program shall identify all documentation (including regulatory documentation) and other deliverables to be provided by Hollister-Stier to Client pursuant to this Agreement and appended he▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇ 4 ("the Documentation") of this Agreement. Hollister-Stier shall use its commercially reasonable best efforts t▇ ▇▇▇▇▇▇▇▇ ▇▇▇ CTM Program in a timely fashion in accordance with the Schedule agreed upon by the Parties and set forth in Exhibit 3 of this Agreement. If Hollister-Stier is unable to complete any stage of the CTM Program i▇ ▇▇▇ ▇▇▇▇▇▇ ▇▇mes, it shall immediately notify Client, in writing, of the delay, and the reason therefor. Hollister-Stier shall negotiate with Client a mutually acceptable da▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇n for the respective stage of the CTM Program, and Hollister-Stier shall use its commercially reasonable best efforts t▇ ▇▇▇▇▇▇▇▇ ▇▇▇ CTM Program within such newly agreed upon time.