Common use of Drug Approval Applications Clause in Contracts

Drug Approval Applications. Consistent with the Development Plan and Development Budget and as directed by the JDC, the Parties will file applications for regulatory approval required before commercial sale or use of a Product as a drug in a country within the Territory ("Drug Approval Applications") and attempt to obtain regulatory approvals in each country in the Territory in which the Parties either individually or jointly intend to commercialize Products. JT will be responsible for filing in its name and shall own all regulatory submissions relating to Products including, without limitation, all INDs and NDAs, in each country in the JT Territory, in which Products will be commercialized. Tularik will be responsible for filing in its name and shall own all regulatory submissions, including, without limitation, all INDs and NDAs in each country in the Tularik Territory in which Products will be commercialized by Tularik. The JDC will be responsible for designating a Party to be responsible for filing all regulatory submissions in each country in the Co-Promotion Territory in which Products will be commercialized. The Party not responsible for filing regulatory submissions for Products in a country pursuant to this Agreement shall have a right to cross-reference to all such filings made by the other Party in any country. The Parties will cooperate in the preparation of all such regulatory filings and in obtaining Regulatory Approvals under this Section 3(i).

Drug Approval Applications. Consistent with the Development Plan and Development Budget and as directed by the JDC, the Parties (or their Affiliates) will file applications for regulatory approval required before commercial sale or use of a Product as a drug in a country within the Territory ("Drug Approval Applications") and attempt to obtain regulatory approvals Regulatory Approvals in each country in the Territory in which the Parties Parties, either individually or jointly jointly, intend to commercialize Products. JT will be responsible for filing in its name and shall own all regulatory submissions relating to Products including, without limitation, all INDs and NDAs, in each country in the JT Territory, Territory in which Products will be commercialized. Tularik will be responsible for filing in its name and shall own all regulatory submissions, including, without limitation, all INDs and NDAs NDAs, in each country in the Tularik Territory in which Products will be commercialized by Tularikcommercialized. The JDC will be responsible for designating a Party to be responsible for filing all regulatory submissions in each country in the Co-Co- Promotion Territory in which Products will be commercialized. The Party not responsible for filing regulatory submissions for Products a Product in a country pursuant to this Agreement shall have a right to cross-reference to all such filings made by the other Party for such Product in any country. The Parties will cooperate in the preparation of all such regulatory filings and in obtaining Regulatory Approvals under this Section 3(i)4.11, including without limitation providing access to each Party's data and information obtained under the Program to the extent necessary for obtaining Regulatory Approvals of Products.