Common use of DMF Clause in Contracts

DMF. ABX shall be responsible for the preparation, filing, prosecution and maintenance of, and shall own, the DMF specific for each Candidate Drug and Licensed Product (“Drug DMF”) that ABX manufactures or has manufactured until such time, after ABX or its subcontractor is no longer manufacturing such Candidate Drug or Licensed Product, as AZ requests that such Drug DMF be assigned and transferred to AZ or its designee. ABX shall provide AZ with sufficient opportunity to review and comment on such Drug DMF prior to any filing with any regulatory authority, and ABX shall incorporate the reasonable requests of AZ regarding the filing, prosecution and maintenance of the Drug DMF for each such Candidate Drug and Licensed Product. ABX shall (a) notify AZ as early as reasonably practicable in advance of all meetings and significant communications with any regulatory or governmental authority concerning any such Drug DMF and shall permit AZ to participate in such meetings, (b) promptly prepare and deliver to AZ complete and accurate minutes of any such meeting or communications, and (c) promptly forward to AZ copies of all written communications received from any regulatory or governmental authorities with respect to any such Drug DMF upon receipt therefrom. AZ and its employees shall otherwise assist ABX, upon the request of ABX, and to the extent commercially reasonable, in preparing, filing or maintaining such registrations and such Drug DMF. At AZ’s request, as permitted above, ABX shall assign and transfer all of its right, title and interest in and to such Drug DMF to AZ or its designee. Notwithstanding the ownership of a Drug DMF, ABX shall grant to AZ and its sublicensees the right and license to use and reference each Drug DMF with respect to a Candidate Drug and Licensed Product, and the data included or referenced therein, for purposes of exercising its rights under this Agreement. ABX shall file and maintain, and shall solely own, its Plant V DMF, and shall permit AZ to cross reference the same for Candidate Drugs and Licensed Products.