DMF. To the extent required CMC information is not contained in any IND submitted to the FDA, Ignyta shall establish with the FDA a drug master file for the Product (“DMF”) and, if requested by Ignyta, and to the extent that Nerviano has contributed to relevant parts of the CMC section, Nerviano shall assist Ignyta in obtaining the DMF.
DMF. Alliance shall be responsible for all testing and document generation (including without limitation all facilities information and related documentation; chemistry, manufacturing, and control information; regulatory methods and controls; assays and reference standards) necessary for filing a drug master file ("DMF") with the FDA for the production of the drug substance from which each Product is formulated. Alliance shall also be responsible for filing such DMF with the FDA for the production of the drug substance from which each Product is formulated. Alliance shall use reasonable efforts to defend the DMF information as required by the FDA in order to permit Schering to maintain approval of the Drug Approval Application in which such DMF is incorporated by reference.
DMF. With respect to the DMFs for Substance and Product, Section 3.5 of the License Agreement is hereby incorporated by reference, as if stated in its entirety, herein. Schering shall keep current any such DMFs.
DMF. (a) Notwithstanding anything in this Agreement to the contrary, Alkermes will maintain, [***], the DMF and hereby grants Recro and its Sublicensees (i) the right to reference the DMF in the NDA for Finished Meloxicam and (ii) the right to access Confidential Information referenced in the DMF that Alkermes reasonably believes is not highly sensitive, until the time of the technology transfer pursuant to Section 10.4(b), after which the Technology Transfer Information will be transferred to Recro in accordance with Section 10.4(b). During the course of the FDA’s review of the NDA for BC Parenteral Meloxicam, Recro and its Sublicensees will inform Alkermes of any comments it receives from the FDA (including indication of deficiencies) regarding the Manufacture of BC Parenteral Meloxicam, and Alkermes will consult with Recro in drafting responses to any such comments, subject to Alkermes’ right to maintain confidential any proprietary information set forth in the confidential portions of the DMF.
DMF. Sutro will file the DMF with the FDA. Sutro shall own the DMF and hereby grants to Merck the right to cross-reference the DMF for the Product, but no right to access the underlying data related to the production of the Cell Free Extract. With respect to any territories where Sutro does not have a DMF or a functional equivalent, Sutro will coordinate with Merck, at Merck’s request and expense, the preparation and submission of documents and materials [*] necessary or reasonably useful to obtain and / or maintain Regulatory Approval for a Product in such territory, it being understood that wherever possible Sutro will disclose confidentially Sutro CFE Manufacturing Technology to the applicable Regulatory Authority.
DMF. The Parties acknowledge that MannKind has included certain CMC Information required to be included in an application for Marketing Approval of the Initial Product in a drug master file filed with the FDA and referred to as the DMF. MannKind agrees to file additional drug master file(s) and/or device master file(s) with other Regulatory Authority(ies) as reasonably requested by United Therapeutics, and provide the appropriate authorizations to such Regulatory Authority(ies) allowing the right to review and reference such drug master file(s) and/or device master file(s) in support of applications for Marketing Approval for Product submitted by United Therapeutics (or its permitted designee). To the extent practicable, MannKind shall file such drug master file(s) and/or device master file(s) in coordination with United Therapeutics’ efforts to file and prosecute the applicable Regulatory Filings to such Regulatory Authority and shall be responsible, at its sole expense or as otherwise specified in the Development Plan, for providing the applicable Regulatory Authorities with such additional data as they may request (provided, however, that any additional studies that must be conducted to provide such additional data shall be at United Therapeutics’ expense under Section 6.4 to the extent such studies relate solely or substantially to Product), and for correcting any deficiencies of such drug master file(s) and/or device master file(s) identified by such Regulatory Authority, in each case in a reasonably prompt and efficient manner so as to prevent any delay in obtaining Marketing Approvals based on such drug master file(s) and/or device master file(s). MannKind shall be responsible for maintaining the drug master file(s) (including without limitation the DMF) and/or device master file(s) in accordance with applicable laws and ensuring that all CMC Information and other MannKind Know-How incorporated therein is accurate and up to date as necessary to support filing and prosecuting the applicable Regulatory Filing(s) and obtaining and maintaining the applicable regulatory approval(s) (including without limitation investigational new drug applications and Marketing Approvals) hereunder. MannKind shall provide United Therapeutics with true and complete copies of such drug master file(s) and/or device master file(s) (including for clarity, copies of the “closed” portion of such file(s)).
DMF. Supplier shall provide Kala the appropriate documentation allowing Kala to reference Supplier’s DMF in its regulatory filings. Supplier shall also provide Kala and/or the applicable regulatory authority with the appropriate technical documentation for those regulatory filings where a reference to Supplier’s DMF is not sufficient or allowed; provided, however, if Supplier is not permitted to share such information with Kala directly, the information provided to Kala may be redacted. Upon request Supplier shall provide Kala yearly confirmation that it has filed with the FDA the required annual progress report to Supplier’s DMF for the year then ended. Supplier shall provide Kala with written notification of an anticipated amendment to the DMF and any equivalent regulatory filing required by any other Ministry of Health authority as soon as practical with sufficient advance notice, if possible, in order to allow Kala to make necessary changes to its own regulatory filings. The Parties agree to work together in good faith regarding any DMF or similar Filing for other countries. Where applicable, Supplier will provide Kala with a reference letter to Supplier’s Certificate of Suitability for the Product. Kala, on a yearly basis, will inform Supplier on the registration status of the Product up to its approval.
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.
DMF. APG shall maintain a DMF or like filing, suitable for APG's manufacture of Products, with the applicable regulatory agencies (including FDA) and shall ensure that its "active status" is maintained. APG shall use Commercially Reasonable Efforts to timely accomplish, and bear the costs of, preparing for regulatory inspection, approval and associated filings required for the manufacture of Connetics' Products. Connetics shall directly pay or reimburse APG for any fees and payments to such regulatory agencies required for such inspection, approval and associated filings (e.g., any FDA inspection fee); it is understood that Connetics is not responsible for any additional fees and payments related to the general operation of APG's business or facilities. APG will provide letter(s) granting Connetics and its designees the right of cross-reference to the DMF. APG reserves the right to cancel such letter(s) in case of termination of this Agreement.
DMF. Specifications for the bulk drug and finished product . A complete list of all stability protocols for the finished product [...***...] . Quantity of bulk drug available . Outstanding DEA quota issued to Abbott . When was each lot manufactured, originally tested, retested, and what were the results of the testing . All annual updates to any regulatory submissions since approval . Master Batch records for Actiq and Oralet . SOPs for OTFC manufacturing operations . Equipment development history, including functional requirement and factory acceptance testing . Validation reports - equipment and facilities qualification, process validation, cleaning validation and any related computer validation Master production plan and materials plan for Actiq and Oralet FLTS release documentationo Annual product reviews . Audit reports of approved vendors . Approved supplier list and supplier certifications . Any product out of specification or technical complaint investigation reports . Design patent for Oralet/Handle/Overcap
