Xxxxxxx API Supply. Pfizer will manufacture the Product for Xxxxxxx from API that Xxxxxxx shall supply to Pfizer [*]. Xxxxxxx will supply API to Pfizer in quantities sufficient to satisfy Pfizer’s gross manufacturing requirements of the Product, as specified in [*] purchase orders submitted by Pfizer and on lead times discussed and agreed by the Project Managers, but in no event later than [*] days prior to the scheduled start of manufacture. Pfizer will use the API received from Xxxxxxx only for the development activities contemplated by this Agreement and the manufacture of Product for Xxxxxxx and for no other purpose. Pfizer agrees that it will not acquire any right, title or interest in or to the API and will not distribute, sell or otherwise transfer the API to any Third Party or generic manufacturer or otherwise use the API for the manufacture of any generic version of the Product unless otherwise directed by Xxxxxxx in writing. Xxxxxxx will deliver the API, [*], the Facility pursuant to [*] purchase orders that Pfizer issues to Xxxxxxx. Pfizer shall be solely responsible, at its own cost and expense, for the proper storage and handling of all API once it has been accepted into the Facility, including separate storage as a Controlled Substance if and as required by the DEA. In accordance with DEA regulations, Pfizer will produce and maintain complete and accurate records regarding the receipt, storage and use of the API under this Agreement and will provide to Xxxxxxx a copy of its year-end Controlled Substance reconciliation report pertaining to the API. Any API, which is not used as provided in this Agreement shall be returned to Xxxxxxx or otherwise disposed as directed by Xxxxxxx in writing in accordance with Section 10.6(b).
Xxxxxxx API Supply. Pfizer will manufacture the Product for Xxxxxxx from API that Xxxxxxx shall supply to Pfizer [*]. Xxxxxxx will supply API to Pfizer in quantities sufficient to satisfy Pfizer’s gross manufacturing requirements of the Product, as specified in [*] purchase orders submitted by Pfizer and on lead times discussed and agreed by the Project Managers, but in no event later than [*] days prior to the scheduled start of manufacture. Pfizer will use the API received from Xxxxxxx only for the development activities contemplated by this [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Agreement and the manufacture of Product for Xxxxxxx and for no other purpose. Pfizer agrees that it will not acquire any right, title or interest in or to the API and will not distribute, sell or otherwise transfer the API to any Third Party or generic manufacturer or otherwise use the API for the manufacture of any generic version of the Product unless otherwise directed by Xxxxxxx in writing. Xxxxxxx will deliver the API, [*], the Facility pursuant to [*] purchase orders that Pfizer issues to Xxxxxxx. Pfizer shall be solely responsible, at its own cost and expense, for the proper storage and handling of all API once it has been accepted into the Facility, including separate storage as a Controlled Substance if and as required by the DEA. In accordance with DEA regulations, Pfizer will produce and maintain complete and accurate records regarding the receipt, storage and use of the API under this Agreement and will provide to Xxxxxxx a copy of its year-end Controlled Substance reconciliation report pertaining to the API. Any API, which is not used as provided in this Agreement shall be returned to Xxxxxxx or otherwise disposed as directed by Xxxxxxx in writing in accordance with Section 10.6(b).
