Common use of Sharing of Regulatory Filings Clause in Contracts

Sharing of Regulatory Filings. Without limiting Section 4.8, each Party shall permit the other Party to access, and shall provide the other Party with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this Agreement, all of such Party’s, its Affiliates’ and, to the extent it has the right to do so, its Marketing Partners’ Regulatory Materials (including Data), with respect to the Products in the Field in the Territory.

Appears in 4 contracts

Samples: Development and Commercialization Agreement (Mesoblast LTD), Development and Commercialization Agreement (Mesoblast LTD), Development and Commercialization Agreement (Cephalon Inc)

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Sharing of Regulatory Filings. Without limiting Section 4.8, each Each Party shall permit the other Party to access, and shall provide the other Party with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this AGREEMENT, the Ex-U.S. Commercialization Agreement and the Global Supply Agreement, all of such Party’sits, its Affiliates’ andAFFILIATES' and their respective suppliers' DATA, to the extent it has the right to do so, its Marketing Partners’ Regulatory Materials (including Data), regulatory filings and regulatory communications associated with respect to the Products in the Field in the Territoryany submissions for MAA APPROVALS or other approvals for COMPOUND and/or PRODUCT.

Appears in 2 contracts

Samples: Commercialization Agreement (Genta Inc De/), Commercialization Agreement (Genta Incorporated /De/)

Sharing of Regulatory Filings. Without limiting Section 4.85.2.3 above, each Party shall shall, upon reasonable request of the other Party, permit the other Party to access, and shall provide the other Party with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this Agreement, all of such Party’s, and its Affiliates’ and, to the extent it has the right to do so, its Marketing PartnerslicenseesRegulatory Materials (including Data)and Sublicensees’ data, regulatory filings and regulatory communications associated with respect to the Products in the Field any submissions of XXXx or other approvals for Product in the Territory.

Appears in 2 contracts

Samples: Trademark License Agreement, Trademark License Agreement (Amicus Therapeutics Inc)

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Sharing of Regulatory Filings. Without limiting Section 4.8, each Each Party shall permit the other Party to access, and shall provide the other Party with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this Agreement, all of such Party’s, its Affiliates’ and, to the extent it has the right to do so, its Marketing PartnersSublicenseesKnow-How, Regulatory Materials (including Data), with respect to Filings as are necessary for the Development and Commercialization of Licensed Products in the Field in the each Parties respective Territory.

Appears in 2 contracts

Samples: License Agreement (Checkpoint Therapeutics, Inc.), License Agreement (Checkpoint Therapeutics, Inc.)

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