Drug Master Files. Santaris shall have the right to cross-reference Enzon’s drug master file for the manufacture of LNA Monomers and Products for the sole purpose of enabling Santaris to manufacture and supply Product for Commercialization in the Santaris Territory pursuant to Section 6.3(b)(ii). Enzon shall have the right to cross-reference Santaris’s drug master file for the manufacture of LNA Monomers for the manufacture of Selected LNA Compounds and Products for the sole purpose of enabling Enzon to manufacture and supply LNA Monomers for the manufacture of Selected LNA Compounds and Products for Commercialization in the Enzon Territory pursuant to Section 6.3(a)(ii).
Drug Master Files. GMN shall grant PDL a right of reference to their applicable Drug Master Files to the extent necessary to enable PDL to apply for, obtain and maintain Regulatory Approvals for any of the Products. Such Drug Master Files shall be maintained by GMN with the FDA and any other applicable Regulatory Authorities during the Term consistent with applicable Law.
Drug Master Files. Mallinckrodt shall be responsible for maintaining the DMFs for the API, and all licensing, registrations and permits relating thereto or relating to the operation of the Facility or otherwise required to fulfill its obligations under this Agreement, and shall pay all fees (including Facility fees) relating thereto. Mallinckrodt shall provide, or cooperate with Osm Kft to provide, the appropriate authorizations to each applicable Regulatory Authority allowing Osm Kft and/or its designees the right to reference all DMFs for the API to support any regulatory filing for any Finished Products. Mallinckrodt shall use commercially reasonable efforts to assist Osm Kft in connection with Osm Kft’s use of any such DMFs, provided that Osm Kft shall reimburse Mallinckrodt for any reasonable out-of-pocket expenditure by Mallinckrodt incurred at the request of Osm Kft for filing any DMFs outside of the United States. Mallinckrodt shall be responsible for maintaining any such DMF(s) in accordance with Applicable Laws and ensuring all data and information incorporated therein is accurate and current as necessary. Mallinckrodt will notify Osm Kft at least twelve (12) months in advance (unless a lesser time to implement any change is dictated by law) of any and all material changes in its production, testing or packaging procedures in the DMF documented process for any API as required by FDA’s “Guidance for Industry to an approved NDA or ANDA.” The Parties acknowledge the purpose of the immediately preceding sentence is to allow Osm Kft a reasonable amount of time to receive appropriate regulatory approval prior to Mallinckrodt implementing a significant change to its DMF.
Drug Master Files. In the case of drug master files containing proprietary company information, Manufacturer will provide Anterios with the necessary information on its Facility and/or its Equipment for regulatory submissions and will grant Anterios approval to reference such information as Anterios deems necessary.
Drug Master Files. Supplier will routinely update and keep current all information pertinent to maintain the Drug Master Files relating to the Manufacture of the Product at the production site of Supplier. Supplier will fully support and reasonably assist Customer with its filing of any application with respect to the Product with any Applicable Regulatory Authority at Customer’s expense.
Drug Master Files. CAMBREX shall provide, or cooperate with RAPTOR to provide, the appropriate authorizations to each applicable Regulatory Authority allowing RAPTOR (and/or its designee) the right to reference all Drug Master Files to support any regulatory filing for any Product developed, manufactured and/or commercialized by RAPTOR, its Affiliates and/or licensees. If the [***] filed with the FDA as of the Effective Date is not sufficient to support the applicable regulatory filing for a Product, CAMBREX shall supplement such Drug Master File or file a separate Drug Master File(s) with the applicable Regulatory Authority(ies) (including, if applicable, the EMEA,) as necessary to support such regulatory filing(s); provided that [***]. Any such new DMF filing will also require process validation and pilot work, and [***]. In addition, RAPTOR agrees to purchase [***] of API manufactured for the purposes of performing such validation/pilot work. CAMBREX shall use commercially reasonable efforts to correct any deficiencies of such Drug Master File(s) identified by any Regulatory Authority in a prompt and efficient manner so as to prevent any delay in RAPTOR (or any of its Affiliates or licensees) obtaining regulatory approval for a Product based on such Drug Master File(s). In addition, CAMBREX shall be responsible for maintaining such Drug Master File(s) in accordance with Applicable Laws and ensuring that all data and information incorporated therein is accurate and current as necessary to support obtaining and maintaining the applicable regulatory filing(s) and regulatory approval(s) by RAPTOR (and/or its designees) provided that [***].
Drug Master Files. Producer shall, if requested by Purchaser and at Purchaser’s cost with respect to any Supplied Product, prepare, file and maintain, as applicable, with the FDA, and such other Governmental Authorities as the Parties may agree in writing, a drug master file (a “DMF”) with respect to the manufacturing process for the Supplied Product. Producer shall and does hereby grant Purchaser and its Affiliates and licensees, as applicable, the right to reference each such DMF in or for any filings, reports, registrations or other communications that Purchaser or its Affiliates or licensees, as applicable may make or have made with any Governmental Authority in order to obtain or maintain regulatory approvals of the Supplied Product in any applicable territory.
Drug Master Files. If either Party or its Affiliates, licensees or Sublicensees has, during the Term, a Drug Master File with the FDA or equivalent that contains information necessary or useful to support or maintain an IND or application for Regulatory Approval or Pricing Approval (including as relating to any Licensee Technology arising after the Effective Date, in the case of Licensee, or Mersana Technology arising after the Effective Date, in the case of Mersana): such Party (x) shall notify the other Party of such Drug Master File and any subsequent amendments or changes made to such Drug Master File; (y) keep, or cause its Affiliate, licensee or Sublicensee, as applicable, to keep, each such Drug Master File properly maintained and up-to-date; and (z) in accordance with Section 2.5, shall have, and shall have the further right to grant Affiliates and Third Parties, the rights set forth in Section 2.5.
Drug Master Files. At the ***, ***shall be responsible for:
Drug Master Files. Lundbeck and Centaur will in parallel and in close ----------------- cooperation prepare and regularly update (i) drug master files regarding manufacturing processes (known as "DMF 2") and regarding facilities (known as "DMF 1") for Bulk Substance for development purposes to be filed with and to comply with both standards directed by FDA and regulatory authorities in the Territory (the "DMF's"), and (ii) chemical manufacturing control (known as "CMC")-documentation, including but not limited to documentation on formulation of tablets being Licensed Products, to be filed with and to comply with the standards of the regulatory authorities in the Territory (the "CMC-documentation"). The DMF's and the CMC-documentation shall be made available to the other party within a reasonable time after such is available and upon the reasonable request by the other part. The DMF's and the CMC-documentation shall be regarded as part of Synthesis Data and shall be made available at no additional charge to the other party other than that the costs for preparing these files shall be included by the parties in the costs recoverable in accordance with Section 6.5.
