CMC Documentation Sample Clauses
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CMC Documentation. Within [***] days of Hovione’s receipt of Customer’s written request, Hovione shall supply, at Customer’s sole expense, all information required by Customer in support of the Chemistry, Manufacturing & Control (“CMC”) section of any NDA or other filings to be submitted by Customer or its Affiliates in the Territory with the Regulatory Authorities for any product containing Product Manufactured by Hovione under this Agreement. Hovione shall co-operate with, and provide support and assistance to, at Customer’s expense, any consultant that Customer or its Affiliates selects to write the documentation in the CMC section.
CMC Documentation. Heraeus shall supply all information required by PONIARD in support of the Chemistry, Manufacturing & Control (“CMC”) section of PONIARD’s regulatory filings for Picoplatin API. Heraeus shall cooperate with, and provide timely support and assistance to, any consultant that PONIARD selects to write the documentation described in this Section 2.5.
CMC Documentation. Upon ACHAOGEN’s written request, HOVIONE shall supply, [***], all information required by ACHAOGEN in support of the Chemistry, Manufacturing & Control (“CMC”) Section of any NDA or other filings to be filed by ACHAOGEN or its Affiliates in the Territory with the Regulatory Authorities for any product, containing Product Manufactured by HOVIONE, under this Agreement. HOVIONE shall co-operate with, and provide support and assistance to, [***], any consultant that ACHAOGEN or its Affiliates selects to write the documentation in the CMC section.
CMC Documentation. Upon COMPANY’s written request, HOVIONE shall supply [*****] all information required by COMPANY in support of the Chemistry, Manufacturing & Control (“CMC”) section of any NDA or other filings to be filed by COMPANY, its Affiliates, its Licensees or other designee in the Territory with the Regulatory Authorities for the Product containing API Manufactured by HOVIONE under this Agreement. HOVIONE shall co-operate with, and provide support and assistance to [*****] any consultant that COMPANY, its Affiliates or its Licensees selects to write the documentation in the CMC section; provided that, any such consultant is (i) subject to written obligations of confidentiality and non-use protecting HOVIONE’s Confidential Information that are at least as restrictive as those in this Agreement, and (ii) not a competitor of HOVIONE.