Common use of Development Stage Clause in Contracts

Development Stage. 4.1 Preparation of Third Party Manufacturer for the Joint Development Stage 3.7.1 The Parties agree that [ * ] shall be approached first as the potential major third party manufacturer for the purpose of manufacturing Products and Drug Products meeting the cGMP standards required by the U.S FDA and supplying Products in suitable quantities for use in each Party’s individual development program and (if applicable) in the Joint Development Program. As QBI will be the first Party requiring such cGMP quality of Products, QBI will negotiate and enter into a Manufacturing and Supply Agreements securing, however, that Atugen is fully embedded into the flow of information by receiving copies of reports, changes of the program and project, quantities produced and delivered and that Atugen shall have the right and option to be supplied byQBI’s selected manufacturers. on Atugen’s expense Atugen shall prepare and provide to such common third-party manufacturers and to QBI an up-to-date dossier, which atugen has developed with its partner and which has proven to be suitable for a production of specific 801-siRNA molecules at such partners’ manufacturing facilities. It is understood and agreed that the manufacturers will have to adapt such Manufacturing Process File (the “Manufacturing Process File “) to its own conditions. The Manufacturing Process File intends to describe the Product manufacturing process in sufficient detail (and in any event, at least that level of detail indicated in Schedule D) to (i) enable the preparation of a Drug Master File (DMF) for submission in the IND application and (ii) to enable the selected third party manufacturer (or manufacturers) to practice the Product manufacturing process. For the removal of doubt it is clarified that Atugen’s obligations to prepare, deliver, and update the Manufacturing Process File pursuant to this Section 4.1 shall remain in effect even if Atugen does not participate in the Joint Development Program or its participation in the Collaboration is terminated pursuant to Section 11; however, if Atugen terminates this Agreement in its entirety pursuant to Section 11.2 (ii), Atugen has no longer such obligation pursuant to this Section 4.1. For the removal of doubt Atugen has no further obligation to prepare and provide additional information other than given in the Manufacturing Process File, even if this information may not be sufficient for the preparation of a DMF.