Access to Drug Master Files. Where applicable, Company will grant Client reference rights to all Drug Master Files (the “DMF”) and Site Master Files (the “SMF”) necessary to support Client’s regulatory filings for the API and/or Drug Product. To affect this, Company will execute certain letters of authorization, which will be delivered to the appropriate regulatory authorities to permit them to consult Company’s DMF and SMF in their review of Client’s API and/or Drug Product regulatory submissions. Company will send copies of such authorization letters to Client. Company will update its DMF and SMF annually and will inform Client prior to making any modifications thereto in order to permit Client to amend or supplement any affected regulatory submissions and filings for API and/or Drug Product.
Access to Drug Master Files. Hospira shall grant Cempra and its Affiliates sublicensable reference rights (transferable with this Agreement in the event of any assignment of this Agreement permitted under Section 12.5) to all Drug Master Files Hospira maintains for the Facility as reasonably necessary to support Cempra’s [*] regulatory filings, applications, and approvals for the Product, but only in the case where Hospira is the manufacturer of the Product for sale to Cempra[*]. [*] To effect the rights granted by Hospira above, Hospira shall execute certain letters of authorization, which shall be delivered to the appropriate Regulatory Authorities to permit them to consult Hospira’s DMFs in their review of Cempra’s [*] regulatory submissions. Hospira shall send copies of such authorization letters to Cempra [*]. Hospira shall update its DMFs subject to the rights granted above annually and shall inform Cempra prior to making any modifications thereto in order to permit Cempra to amend or supplement any affected regulatory submissions, filings, and/or approvals for the Product.
Access to Drug Master Files. CyDex hereby grants Hospira reference rights to all DMF/CEPs necessary to support Hospira’s applications for marketing authorizations of Finished Products (but not for any other purpose). To effect this, CyDex shall execute certain documentation (“Authorization Letters”) which shall be delivered to the appropriate Regulatory Authorities permitting such Regulatory Authorities to consult CyDex’s DMF/CEPs in their review of Hospira’s Finished Products marketing applications. CyDex shall send copies of such Authorization Letters to Hospira. CyDex shall provide Hospira appropriate copies of the Open/Applicant’s part of the DMF/CEP to use for Hospira’s Finished Products Regulatory Filings.
Access to Drug Master Files. Hospira shall grant Company reference rights to all Drug Master Files (“DMFs”) necessary to support Company’s applications for and/or amendments of marketing authorizations of Product. To effect this, Hospira shall execute certain documentation (“Letters of Authorization”) which shall be delivered to the appropriate Regulatory Authorities permitting such Regulatory Authorities to consult Hospira’s DMFs in their review of Company’s Product marketing authorization applications and/or amendments to existing marketing authorizations for Product. Hospira shall send copies of such Authorization Letters to Company. Hospira shall update its DMFs annually, or otherwise, as required by applicable regulations and shall inform Company prior to any modifications thereto in order to permit Company to amend or supplement any affected regulatory applications, marketing authorizations, and/or related filings for Product.
Access to Drug Master Files. Hospira shall grant OBI reference rights to all Drug Master Files (“DMFs”) necessary to support OBI’s applications for marketing authorizations of the Products. To affect this, Hospira shall promptly execute certain documentation (“Letters of Authorization”) which shall be delivered to the appropriate Regulatory Authorities permitting such Regulatory Authorities to consult Hospira’s DMFs in their review of OBI’s Product marketing applications. Hospira shall promptly Hospira – Oxygen Biotherapeutics Agreement send copies of such Authorization Letters to OBI. Hospira shall update its DMFs annually and shall inform OBI prior to any modifications thereto in order to permit OBI to amend or supplement any affected regulatory applications and filings for Product.
Access to Drug Master Files. Abbott shall manufacture Product that conforms with Product Specifications. Abbott shall xxxxx Cubist reference rights to all DMFs necessary to support Cubist's applications for marketing authorizations of Product. To effect this, Abbott shall execute Letters of Authorization to regulatory authorities permitting such regulatory authorities to consult Xxxxxx'x DMFs in their review of Cubist's Product marketing authorizations. Abbott shall send copies of such Authorization Letters to Cubist. Abbott shall update its DMFs annually and shall inform Cubist prior to any modifications in order to permit Cubist to amend or supplement any affected regulatory applications and files for Product.
Access to Drug Master Files. Where applicable, Pfizer will xxxxx Xxxxxxx reference rights to all Drug Master Files and Site Master Files necessary to support Xxxxxxx’x regulatory filings for the Product. To affect this, Pfizer will execute certain letters of authorization, which will be delivered to the appropriate Regulatory Authorities to permit them to consult Pfizer’s DMFs and SMFs in their review of Xxxxxxx’x Product regulatory submissions. Pfizer will send copies of such authorization letters to Xxxxxxx. Pfizer will update its DMFs and SMFs annually and will inform Xxxxxxx prior to making any modifications thereto in order to permit Xxxxxxx to amend or supplement any affected regulatory submissions and filings for Product.
Access to Drug Master Files. Hospira shall grant Hologic reference rights to all Drug Master Files (“DMFs”) necessary to support Hologic’s filings of Product. To effect this, Hospira shall execute certain documentation (“Letters of Authorization”) which shall be delivered to the appropriate Regulatory Authorities permitting such Regulatory Authorities to consult Hospira’s DMFs in their review of Hologic’s Product marketing applications. Hospira shall send copies of such Authorization Letters to Hologic. Hospira shall update its DMFs annually and shall inform Hologic prior to any modifications thereto in order to permit Hologic to amend or supplement any affected regulatory applications and filings for Product.
Access to Drug Master Files. If requested by Durata, Hospira shall grant Durata reference rights to all Drug Master Files (“DMFs”) necessary to support Durata’s Applications for Regulatory Approval of the Product. To affect this, Hospira shall execute certain documentation (“Letters of Authorization”) which shall be delivered to the appropriate Regulatory Authorities permitting such Regulatory Authorities to consult Hospira’s DMFs in their review of Durata’s Product regulatory submissions. Hospira shall send copies of such Authorization Letters to Durata and, at Durata’s request, to the applicable Regulatory Authorities. Hospira shall update its DMFs annually and shall inform Durata prior to any modifications thereto in order to permit Durata to amend or supplement any affected regulatory submissions and filings for Product.
Access to Drug Master Files. Hospira shall grant Genzyme reference rights to all Drug Master Files (“DMFs”) necessary to support Genzyme’s applications for marketing authorizations of Products. To affect this, Hospira shall execute Letters of Authorization which shall be delivered to the appropriate Regulatory Authorities permitting such Regulatory Authorities to consult Hospira’s DMFs in their review of Genzyme’s Product marketing applications. Hospira shall send copies of such Letters of Authorization to Genzyme. Hospira shall update its DMFs annually and shall inform Genzyme prior to any modifications thereto in order to permit Genzyme to amend or supplement any affected regulatory applications and filings for the Products.
