definiens: as that term is defined in 21 C.F.R. § 314.3(b ), and any foreign equivalents, to any and a ll regulatory filings, data and information within the Faes Know - How relating to the Compound or Subject P roducts, including without limitation that related to pharmacology, toxicology, preclinical testing, 16 * [ NOTE : CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT CONFIDENTIAL INFORMATION HAS BEEN OMITTED . CON FIDENTIAL TREATMENT HAS BEEN REQUESTED FOR THIS CONFIDENTIAL INFORMATIO N. THE CONFIDENTIAL PORTIONS HAVE BEEN PROVIDED SEPARATELY TO THE SECUR ITIES AND EXCHANGE COMMISSION . ] clinical testing, chemistry, manufacturing and cont rols data, batch records, trials and studies, safet y and efficacy, manufacturing information, analytical and quality control, and agrees to sign, and cause its Affiliates to sign, any instruments reasonably requ ested by Inspire in order to effect such grant, sol ely for the purposes of developing and seeking regulatory a pproval in the Inspire Principal Territory of Inspi re Principal Products and in the Inspire Ophthalmic Te rritory of Inspire Ophthalmic Products and conducti ng such other activities as are contemplated by this A greement . In addition, Faes hereby grants to Inspir e the full right to use and refer to any Drug Master File for the Compound and will provide a copy thereof t o Inspire upon Inspire ’s request solely for the purpo ses of developing and seeking regulatory approval i n the Inspire Principal Territory of Inspire Principal Pr oducts and in the Inspire Ophthalmic Territory of I nspire Ophthalmic Products and conducting such other activ ities as are contemplated by this Agreement