SHIRATORI definition
Examples of SHIRATORI in a sentence
Upon receipt of any such claim or suit by any such DSP Indemnitee, such DSP Indemnitee shall promptly notify SHIRATORI in writing of such claim or suit and shall permit SHIRATORI to defend against and control the defense of such claim or suit, provided that SHIRATORI shall not compromise or settle such claim or suit without the written approval of such DSP Indemnitee, and such DSP Indemnitee shall have the right to participate in the defense of such claim or suit at its own expense.
Commencing three (3) months after the date of this Supply Agreement and every three (3) months thereafter, SHIRATORI shall furnish BIOMARIN and DSP with reports, in English, on the manufacturing portion of the development plan related to the Drug Substance, including scale up, process validation, and etc.
SHIRATORI shall furnish to BIOMARIN and DSP the report by such agency of such visit, to the extent that such report relates to Drug Substance, within ten (10) business days of SHIRATORI’s receipt of such report, and BIOMARIN shall have the right to comment on any response by SHIRATORI to such inspecting agency.
The relationship between DSP, BIOMARIN and SHIRATORI is that of independent contractors.
DSP acknowledges that quantity actually manufactured by SHIRATORI in order to fulfill each delivery of Drug Substance under a purchase order may be between one hundred percent (100%) to one hundred and ten percent (110%) of the amount indicated in the purchase order and that DSP agrees to purchase the quantity actually manufactured by SHIRATORI, within the foregoing limitations, regardless of the quantity specified in DSP’s firm purchase order.
SHIRATORI shall provide BIOMARIN with confirmation of its acceptance, or partial acceptance, of the DSP purchase order at the same time it accepts the DSP purchase order.
The Drug Substance manufactured by SHIRATORI shall be in compliance with the specifications as set forth in the Annex A of this Supply Agreement (hereinafter referred to as “Specifications”) and in compliance with the quality agreement to be entered into between BIOMARIN, SHIRATORI and DSP within ninety (90) days after the Effective Date as such Specification and quality agreement may be modified from time to time by the written agreement of BIOMARIN, SHIRATORI and DSP.
Within forty-five (45) days after the Effective Date, DSP shall also disclose to BIOMARIN the DSP Drug Substance Manufacturing Know-How that DSP possesses (and shall cause SHIRATORI to disclose such DSP Drug Substance Manufacturing Know-How that SHIRATORI possesses) at the time of such disclosure.
Within [****] after receipt of a purchase order from BIOMARIN, DSP shall accept the same such portion of the BIOMARIN purchase order as SHIRATORI accepted of the DSP purchase order issued in connection with the BIOMARIN purchase order.
SHIRATORI shall perform quality assurance and control tests on each lot of Drug Substance, as required by the Specifications, before delivery and shall prepare a written report of the results of such tests.