Development and Commercialization Responsibilities. (a) Sublicensee shall be solely responsible for, and shall bear the entire cost of performing or having performed, all Development of Licensed Compounds and Licensed Products in the Sublicensed Field in the Territory, and all Commercialization of Licensed Products in the Sublicensed Field in the Territory, and the satisfaction of all regulatory requirements with respect thereto. As between the Parties, and subject to the provisions of Article IV. Sublicensee shall assume responsibility for fulfilling the obligations set forth in Article 3 of the Head License for the Sublicensed Field in the Territory. (b) Notwithstanding the provisions of Section 2.2(a), neither Party shall file for Regulatory Approval or apply for or seek to obtain any designation, priority, exclusivity, accelerated approval, priority review voucher or similar right (including any orphan drug, rare disease, pediatric disease, tropical disease or breakthrough therapy or similar designations) with respect to any Licensed Compounds and Licensed Products in any country or jurisdiction in the Territory (the Party first seeking Regulatory Approval, the “Filing Party”), without providing prior written notice to the non-Filing Party. If requested in writing by the non-Filing Party within seven (7) Business Days of receipt of such notice from the Filing Party, the Parties shall discuss the regulatory pathway for the Licensed Compounds and Licensed Products in the Territory, and the Parties shall agree whether or not the Filing Party will file for Regulatory Approval and which Party shall be responsible for listings in the FDA’s Orange Book, and under similar or equivalent laws in other countries or jurisdictions in the Territory, seeking to obtain any designation, priority, exclusivity, accelerated approval, priority review voucher or similar right (including any orphan drug, rare disease, pediatric disease, tropical disease or breakthrough therapy or similar designations), and for which Patents the Parties will file patent term extensions; provided, however, that in the event the Parties are not able to agree to any of the foregoing within a period of thirty (30) days following the date of receipt of the initial notice provided to the non-Filing Party, Sublicensor shall make the final determination in respect thereto; provided, such determination must be reasonable under the then-existing circumstances. Without limiting the foregoing, neither Party shall be required to provide legally privileged or commercially sensitive information in connection with the foregoing items unless and until procedures reasonably acceptable to the Party making such disclosure are in place to protect such privilege or information exchange.
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Development and Commercialization Responsibilities. (a) Sublicensee shall be solely responsible for, and shall bear the entire cost of performing or having performed, all Development of Licensed Compounds Proprietary Drugs and Licensed Products in the Sublicensed Field in the Territory, and all Commercialization of Licensed Products in the Sublicensed Field in the Territory, and the satisfaction of all regulatory requirements with respect thereto. As between the Parties, and subject to the provisions of Article IV. , Sublicensee shall assume responsibility for fulfilling the obligations set forth in Article 3 4, Article 5, Article 6, and Article 7 of the Head License for the Sublicensed Field in the Territory.
(b) Notwithstanding the provisions of Section 2.2(a), neither Party shall file for Regulatory Approval or apply for or seek to obtain any designation, priority, exclusivity, accelerated approval, priority review voucher or similar right (including any orphan drug, rare disease, pediatric disease, tropical disease or breakthrough therapy or similar designations) with respect to any Licensed Compounds Proprietary Drugs and Licensed Products in any country or jurisdiction in the Territory (the Party first seeking Regulatory Approval, the “Filing Party”), without providing prior written notice to the non-Filing Party. If requested in writing by the non-Filing Party within seven (7) Business Days of receipt of such notice from the Filing Party, the Parties shall discuss the regulatory pathway for the Licensed Compounds Proprietary Drugs and Licensed Products in the Territory, and the Parties shall agree whether or not the Filing Party will file for Regulatory Approval and which Party shall be responsible for listings in the FDA’s Orange Book, and under similar or equivalent laws in other countries or jurisdictions in the Territory, seeking to obtain any designation, priority, exclusivity, accelerated approval, priority review voucher or similar right (including any orphan drug, rare disease, pediatric disease, tropical disease or breakthrough therapy or similar designations), and for which Patents the Parties will file patent term extensions; provided, however, that in the event the Parties are not able to agree to any of the foregoing within a period of thirty (30) days following the date of receipt of the initial notice provided to the non-Filing Party, Sublicensor shall make the final determination in respect thereto; provided, such determination must be reasonable under the then-existing circumstances. Without limiting the foregoing, neither Party shall be required to provide legally privileged or commercially sensitive information in connection with the foregoing items unless and until procedures reasonably acceptable to the Party making such disclosure are in place to protect such privilege or information exchange.
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