Common use of Program Materials Clause in Contracts

Program Materials. (a) Customer will provide Gallus with sufficient amounts of the Customer Provided Materials with which to perform the Services as specified in the Work Statement. Unless the Work Statement includes the development of a manufacturing process by Gallus, Customer also will provide Gallus with all necessary information to effect the reliable transfer of the Process from Customer to Gallus. (b) Gallus shall procure Process Consumables for use in the Program and each manufacturing run as set forth in the Work Statement. (c) Gallus shall procure Product-Dedicated Equipment, provided the equipment is set forth in a Work Statement and pass through the costs to the Customer as set forth in Section 8 without upcharge. For the avoidance of doubt, purchase of any Product-Dedicated Equipment regardless of whether that equipment is set forth in a Work Statement shall require Customer’s approval in advance of the purchase. Customer may procure certain Product-Dedicated Equipment for use in the Program at its own expense, provided that Customer first provides written notice to Gallus and provides Gallus with an opportunity to confirm that such Product-Dedicated Equipment conforms to the requirements of the Work Statement and is otherwise suitable for use in the performance of the Services. All Product-Dedicated Equipment will be subject to charges from Gallus for activities such as evaluation, installation, qualification, calibration and maintenance. (d) Upon completion of the Program, (i) the Product-Dedicated Equipment will be returned to the Customer, at the Customer’s expense, unless the Parties agree that such Product-Dedicated Equipment will be used in connection with additional services to be provided to Customer in the foreseeable future, and (ii) any remaining Materials will be, at Customer’s election (such election to be made by Customer to Gallus in writing no later than sixty (60) days after Gallus’ issuance of a Certificate of Analysis for the applicable Product), returned to the Customer or destroyed/disposed of by Gallus, in either case at the Customer’s expense. If Customer does not provide such notice to Gallus within such 60-day period, Gallus shall, at Gallus’ election and at Customer’s expense, return to the Customer or destroy/dispose of the applicable Materials. Notwithstanding anything to the contrary contained in this Agreement, (i) Gallus may retain Materials as required by Applicable Law, and (ii) in no event shall Gallus be required to store Materials, Product-Dedicated Equipment or any other materials for more than ninety (90) days after termination or expiration of an applicable Work Statement or this Agreement unless the Parties have entered into an appropriate storage agreement covering such items.

Appears in 2 contracts

Sources: Development and Manufacturing Services Agreement (Mabvax Therapeutics Holdings, Inc.), Development and Manufacturing Services Agreement (Mabvax Therapeutics Holdings, Inc.)

Program Materials. (a) Customer will provide Gallus with sufficient amounts of the Customer Provided Materials with which to perform the Services as specified in the Work Statement. Unless the Work Statement includes the development of a manufacturing process by Gallus, Customer also will provide Gallus with all necessary information to effect the reliable transfer of the Process from Customer to Gallus. (b) Gallus shall procure Process Consumables for use in the Program and each manufacturing run as set forth in the Work Statement. (c) Gallus shall procure Product-Dedicated Equipment, provided the equipment is Equipment as may be set forth in a Work Statement and pass through the costs to the Customer as set forth in Section 8 without upcharge. For the avoidance of doubt, purchase of any Product-Dedicated Equipment regardless of whether that equipment is set forth in a Work Statement shall require Customer’s approval in advance of the purchase8. Customer may procure certain Product-Dedicated Equipment for use in the Program at its own expense, provided that Customer first provides written notice to Gallus and provides Gallus with an opportunity to confirm that such Product-Dedicated Equipment conforms to the requirements of the Work Statement and is otherwise suitable for use in the performance of the Services. All Any such Customer-procured Product-Dedicated Equipment will be subject to charges from Gallus for activities such as evaluation, installation, installation and qualification, calibration . Development and maintenance.Manufacturing Services Agreement CONFIDENTIAL (d) Upon completion of the Program, (i) the Product-Dedicated Equipment will be returned to the Customer, at the Customer’s expense, unless the Parties agree that such Product-Dedicated Equipment will be used in connection with additional services to be provided to Customer in the foreseeable future, and (ii) any remaining Materials will be, at Customer’s election (such election to be made by Customer to Gallus in writing no later than sixty (60) days after Gallus’ issuance of a Certificate of Analysis for the applicable Product), returned to the Customer or destroyed/disposed of by Gallus, in either case at the Customer’s expense. If Customer does not provide such notice to Gallus within such 60-day period, Gallus shall, at Gallus’ election and at Customer’s expense, return to the Customer or destroy/dispose of the applicable Materials. Notwithstanding anything to the contrary contained in this Agreement, (i) Gallus may retain Materials as required by Applicable Law, and (ii) in no event shall Gallus be required to store Materials, Product-Dedicated Equipment or any other materials for more than ninety (90) days after termination or expiration of an applicable Work Statement or this Agreement unless the Parties have entered into an appropriate storage agreement covering such items.

Appears in 1 contract

Sources: Development and Manufacturing Services Agreement (Omni Bio Pharmaceutical, Inc.)