After Regulatory Approval Sample Clauses
After Regulatory Approval. Celgene shall be solely responsible for conducting all Development activities of a Licensed Product in the Field following such Licensed Product’s receipt of Regulatory Approval in any country in the Territory.
After Regulatory Approval. Subsequent to regulatory approval to market the Product in Thailand, Trinity shall continue to issue at quarterly intervals a twelve (12) month forecast estimating its requirements of the Product during the succeeding four quarterly periods. Trinity shall be required to accept or purchase one hundred percent (100%) of the quantity of Product listed for the first quarterly period of each forecast and seventy-five percent (75%) of the quantity of Product listed for the second quarterly period of such forecast, but shall be able to increase or decrease the quantities estimated for the remaining two quarters of such forecast in subsequent forecasts. Trinity shall issue orders or purchase orders (as the case may be) for its Product requirements which shall provide dates and delivery information requirements.
After Regulatory Approval. After the receipt of Regulatory Approval in the U.S. Territory or the European Union in a particular Collaborative Field, termination under this Section 17.3 in such Collaborative Field shall be on a Region-by-Region basis in the ROW Territory and shall become effective [****] after PDL’s receipt of Roche’s written termination notice. During the period between Roche’s termination notice and the effective date of such termination (the “Termination Notice Period”), **** Certain information on this page has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portions.
After Regulatory Approval of Product(s), DMI shall be responsible for commercializing the Product(s) for the Field in at least the Major Market Countries in accordance with the Commercialization Plan for the Product(s) as adopted and amended from time to time by the Advisory Committee. DMI shall also be responsible for commercializing Product(s) for which no Regulatory Approval is required in accordance with the Commercialization Plan for the Product(s) as adopted and amended from time to time by the Advisory Committee.
After Regulatory Approval. After the receipt of Regulatory Approval in the U.S. Territory or the European Union, such termination shall be on a Region-by-Region basis in the ROW Territory and shall become effective [*] after PDL’s receipt of Roche’s written termination notice. During the period between Roche’s termination notice and the effective date of such termination (the “Termination Notice Period”), the Parties shall continue to perform all of their obligations under this Agreement, including sharing costs required to be shared under this Agreement; provided, however, that no payments shall become due or payable for any development or commercialization events first achieved during the Termination Notice Period that apply solely to terminated Regions. Termination of this Agreement pursuant to this Section 17.4(b) shall have the following effects:
(i) Roche shall, at PDL’s written request, promptly (and in any event within [*] after Roche’s receipt of such request) assign and transfer to PDL, all of Roche’s right, title, and interest in and to all regulatory filings (such as INDs and drug master files), Regulatory Approvals, clinical trial agreements (to the extent assignable and not cancelled), and data, including clinical data, materials, and information, in each case to the extent in Roche’s control and to the extent related the Licensed Products in the terminated countries. The costs of such transfers shall be borne [*];
(ii) Roche shall grant to PDL an exclusive, perpetual, irrevocable, fully paid license, under Roche Technology, Collaboration Inventions and patents claiming Collaboration Inventions, to make, have made, use, offer for sale, sell and import Licensed Products in the Asthma Field in the terminated countries;
(iii) All licenses granted to Roche under Section 2.1(b) (and Section 2.1(a) if the U.S. Territory is terminated) shall terminate with respect to the terminated Region; and
(iv) The Parties’ respective co-promotion rights and obligations in the U.S. Territory shall not be affected by any termination of this Agreement pursuant to this Section 17.4(b) with respect to only to Regions that are part of the ROW Territory.
