Contract Manufacturing Pharmaceuticals Agreement

(L) maintain in good condition all manufacturing facilities (with the exception of equipment specialised in the nanotechnology sector) and within CGMP (e.g.B. qualification, calibration, maintenance, validation). 10.6 In the event of termination or expiration of this Agreement for any reason, the Parties shall reasonably cooperate to transfer to NEW ALPHA all chemical ingredients, materials, components, stocks of finished products, restraint models, stability models and work in progress in the possession, preservation or control of GENERICO (and NEW ALPHA shall reimburse GENERICO for reasonable costs related to obtaining and obtaining and controlling this Agreement. manufacture of such articles); and GENERICO will make every move to cooperate with NEW ALPHA on technology transfer issues for product and pipeline products. 2.9 NEW ALPHA makes available, at its own expense, collaborators and collaborators of NEW ALPHA to monitor and approve in writing each step of the manufacturing process of the product and pipelines. 5.1 GENERICO makes every right of it to cooperate with NEW ALPHA and its licensees with a view to obtaining all regulatory approvals for the product and pipelines in each territory, subject to clause 2.2 (C). Without limiting the foregoing, GENERICO will endeavor to provide NEW ALPHA with assistance in data tracking and data analysis related to manufacturing issues that NEW ALPHA may reasonably request. All data and information relating to such media in relation to the product or pipeline product are the exclusive property of NEW ALPHA and may be used free of charge by NEW ALPHA for NEW ALPHA in the manner defined by NEW ALPHA. (v) GENERICO Manufacture of orders does not oblige NEW ALPHA to carry out orders when due, unless NEW ALPHA has previously given its written consent. 5.2 GENERICO will do everything in its power to assist NEW ALPHA in creating and submitting a Chemistry, Manufacturing and Control (CMC) section and an installation base file or other regulatory documents to each regulatory authority, as reasonably requested by NEW ALPHA. Notwithstanding otherwise provided in this Section 5.2, all CMC Information relating exclusively to the Product or a Pipeline Product is the exclusive property of NEW ALPHA and is the protected proprietary information of NEW ALPHA and all CMC Information that does not relate exclusively to the Product or a Pipeline, to the extent that it relates to the Product or a pipeline; are the property of NEW ALPHA and will be proprietary information of NEW ALPHA and may be used free of charge by GENERICO, subject to Section 11 of this Agreement, in connection with the requirements of a regulatory authority.

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