definiens: ) or within the meaning ofany other Applicable Law in which the definitions of adulteration and misbranding are substantially the same as thosecontained in the Act, as the Act and such laws are constituted and effective at the time of delivery and will not be an articlewhich may not under the provisions of Sections 404 and 505 of the Act be introduced into interstate commerce ; provided, however, that the foregoing shall not apply to any API delivered to [COMPANY] prior to Durata ’s receipt of approval of theProduct from the relevant Regulatory Authority, to the extent such delivery is in accordance with Applicable Law ; Page 18 of 51(b ) the API supplied to [COMPANY] hereunder shall have been manufactured in accordance with all applicable cGMP(including ICH Q7A ) and meets the API Specifications set forth on Exhibit 1.2;(c ) all specifications, including API Specifications and Product Specifications, Durata provides to [COMPANY] shallconform in all material respects to the appropriate regulatory filing that Durata files with the relevant Regulatory Authorities;provided, that [COMPANY] has approved of any changes to such specifications;(d ) to the best of its knowledge, the Manufacturing Process does not infringe any patents or know - how of a ThirdParty;(e ) neither it, nor any of its officers, directors or employees has been debarred or convicted of a crime which couldlead to debarment under 21 U.S.C. Section 335a and 335b and that it will not in the performance of its obligations under thisAgreement use the services of any person debarred or suspended under 21 U.S.C. § 335(a ) or ( b);(f ) Durata ’s performance of its obligations under this Agreement will not result in a material violation or breach ofany agreement, contract, commitment or obligation to which Durata is a party or by which it is bound and will not conflictwith or constitute a default under its corporate charter or bylaws ; and(g ) it will not sell Product into any regulatory jurisdiction unless and until it receives any necessary RegulatoryAuthority approvals for such activities