Additional Manufacturing Facility Clause Samples
The "Additional Manufacturing Facility" clause defines the terms under which a party may establish or utilize an extra site for manufacturing goods covered by the agreement. Typically, this clause outlines the conditions that must be met before production can begin at the new facility, such as obtaining prior written consent from the other party, ensuring compliance with quality standards, or passing inspections. Its core practical function is to maintain control and oversight over the production process, ensuring that any expansion in manufacturing capacity does not compromise product quality or contractual obligations.
Additional Manufacturing Facility. On or prior to the first Launch Date of the Product in the Territory, ETHYPHARM shall establish, validate and certify an additional manufacturing facility for the Product, which facility may be owned by ETHYPHARM or a third party contract manufacturer (such facility, the “Additional Manufacturing Facility”). ETHYPHARM shall certify in writing to RELIANT that the Additional Manufacturing Facility (and, as applicable, any third party contract manufacturer): (i) has the requisite capacity to satisfy ETHYPHARM’s production, packaging and delivery obligations, and to meet RELIANT’s order requirements, hereunder with respect to the Product in accordance with the Specifications and the terms and conditions of this Agreement; (ii) complies and will comply with all Applicable Laws and holds all Applicable Permits necessary for the manufacture and packaging of the Product in compliance with cGMP; and (iii) has and will have the irrevocable right to use all Intellectual Property and Confidential Information of ETHYPHARM necessary to manufacture and package the Product in any formulation or dosage form required hereunder, in accordance with the Specifications and the terms and conditions of this Agreement.
Additional Manufacturing Facility. If prior to the termination of Modex' rights and licenses hereunder, the parties determine that CTI will be required to construct an additional facility to meet the demand for the supply of Modex Licensed Products, CTI agrees to use reasonable efforts to locate such facility in Switzerland. CTI's obligation to use reasonable efforts to construct such facility in Switzerland is subject to CTI's determination that such facility would be commercially practicable in light of the demand for CTI's other products and the agreement by the Parties on minimum purchase obligations on the part of Modex that would make such facility profitable. CTI would be permitted to utilize any such facility for the manufacture of products other than Modex Licensed Products.
Additional Manufacturing Facility. On or prior to the first Launch Date of the Product in the Territory, ETHYPHARM shall establish, validate and certify an additional manufacturing facility for the Product, which facility may be owned by ETHYPHARM or a third party contract manufacturer (such facility, the “Additional Manufacturing Facility”). ETHYPHARM shall certify in writing to RELIANT that the Additional Manufacturing Facility (and, as applicable, any third party contract manufacturer): (i) has the requisite capacity to satisfy ETHYPHARM’s production, packaging and delivery obligations, and to meet RELIANT’s order requirements, hereunder with respect to the Product in accordance with the Specifications and the terms and conditions of this Agreement; (ii) complies and will comply with all Applicable Laws and holds all Applicable Permits necessary for the manufacture and packaging of the Product in compliance with cGMP; and (iii) has and will have the irrevocable right to use all Intellectual Property and Confidential Information of ETHYPHARM necessary to manufacture and package the Product in any formulation or dosage form required [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. hereunder, in accordance with the Specifications and the terms and conditions of this Agreement.