Other Licensed Products. 3.3.1 Xcel will have the right, but not the obligation, to perform development studies with Licensed Products beyond the activities contemplated by Sections 3.1 and 3.2 (each such study, a “Development Study”), including: (a) development of Licensed Products in injectable formulations and dosage strengths other than those of the Initial Licensed Product; and (b) development of Licensed Products for indications other than the indication for which POZEN has filed the POZEN NDA. Any Development Study [CONFIDENTIAL TREATMENT REQUESTED], including study designs or protocols for such Development Study, will be subject to review and approval by the CMC.
3.3.2 Xcel will give POZEN written notice of any Xcel Post-Approval Study that is not contemplated by a Marketing Plan previously reviewed by POZEN prior to initiating such Xcel Post-Approval Study, and POZEN will have the right to review and [CONFIDENTIAL TREATMENT REQUESTED] such Xcel Post-Approval Study.
3.3.3 If Xcel desires that a Development Study [CONFIDENTIAL TREATMENT REQUESTED] be conducted, then Xcel will notify POZEN of such desire and will accompany such notice with a description of the objectives for the Development Study. Promptly thereafter, the Parties will prepare a development plan and budget for such Development Study for review and approval by the CMC (each such plan a “Study Plan”). If POZEN desires to perform such Study Plan, (a) it will notify Xcel in writing prior to the meeting at which the Study Plan is submitted to the CMC for review and approval and (b) the Parties will negotiate an agreement with customary terms and conditions for the conduct of the Study Plan, including that Xcel will reimburse POZEN monthly on a net 30 days from invoice date payment basis for POZEN’s Development Fees incurred in connection with such Study Plan. During such time as POZEN holds the IND for the Initial Licensed Product, POZEN agrees to make, on Xcel’s behalf, any required filings to such IND as may be required for performance of any Study Plan.
3.3.4 Xcel will, at its own expense, file any NDAs or other regulatory filings for Licensed Products developed in a Development Study under the terms of this Agreement, and upon approval thereof will (a) obtain and maintain such other Regulatory Approvals as are necessary for the Commercialization of the applicable Licensed Product in the Territory, and (b) exercise Commercially Reasonable Efforts to cause any manufacturers of such Licensed Product (or any compo...
Other Licensed Products. AstraZeneca’s obligation, if any, to pay royalties under Section 6.6.1(a)(3) with respect to each Other Licensed Product shall commence, on a country-by-country basis, with respect to each separate Other Licensed Product, on the date of the First Commercial Sale of such Other Licensed Product by AstraZeneca, its Affiliates or Sublicensees in such country. The obligation shall expire, on a country-by-country basis, with respect to each separate Other Licensed Product, when such Other Licensed Product becomes a Terminated Compound with respect to such country or, if earlier, on the expiration date in such country of the last to expire of any Targacept Patent Right that includes at least one Valid Claim covering the composition of matter of the applicable Other Licensed Compound(s) contained in such Other Licensed Product, a pharmaceutical preparation comprising such Other Licensed Compound(s) or a method of use of such Other Licensed Compound(s) for the indication for which Commercialization Regulatory Approval is obtained with respect to such Other Licensed Product in such country (each, an “Other Licensed Product Royalty-Bearing Claim”). Upon termination of the royalty obligations of AstraZeneca under this Section 6.6.1(b)(2) in a country with respect to an Other Licensed Product, the license grants to AstraZeneca in Section 8.1 shall become fully paid-up and AZ Net Sales of such Other Licensed Product in such country shall be excluded from the royalty calculations set forth in Section 6.6.1(a)(2).
Other Licensed Products. For each Licensed Product being developed by ARES, its Affiliates or sublicensees for which no license fee has yet been paid and that is not subject to Subsection 3.03.01 above, ARES shall pay, or cause to be paid, to SIGNAL the following nonrefundable license fees:
(i) [***]
(ii) [***]
(iii) [***] ***Confidential Treatment Requested 22 ARES shall promptly notify SIGNAL of the occurrence of any event described above.
Other Licensed Products. Catalyst shall have sole responsibility for Manufacturing all Licensed Products (other than Firdapse) for Development and Commercialization in the Territory, and Catalyst shall bear all associated costs and expenses.
Other Licensed Products. With respect to the Licensed Products, other than the Initial Products, Licensee shall have the sole right, but not the obligation, to Develop, seek Marketing Approval, Manufacture and Commercialize such Licensed Products in the Territory during the Term. Notwithstanding the foregoing, POZEN and its licensees (other than Licensee) may, solely for purposes of Commercialization outside the Territory, (i) engage in Development of Licensed Products in the Territory, but may not [* * *] and (ii) Manufacture Licensed Products in the Territory.
Other Licensed Products. The milestone payments for each non- diagnostic Licensed Product shall be as follows: * CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
(i) upon submission of the first IND or equivalent to the FDA or equivalent regulatory agency in any jurisdiction with respect to the applicable non-diagnostic Licensed Product;
(ii) upon submission of the first NDA or equivalent to the FDA or equivalent regulatory agency in any jurisdiction with respect to the applicable non-diagnostic Licensed Product; and
(iii) upon the First Commercial Sale of the applicable non- diagnostic Licensed Product.
Other Licensed Products. Upon the addition of a new Licensed Product, the Parties shall negotiate in good faith such amendments to the terms of this Agreement as may be required to implement the production of or in respect of other terms directly affected by such new Licensed Product, including the applicable Specifications, forecasting, and ordering lead times and quantities, shelf-life and, as provided in Section 3.3, the applicable Purchase Price.
Other Licensed Products. If either party desires to seek and obtain Marketing Authorization for any Other Licensed Product in the Territory, the parties will consult. If both parties agree to seek Marketing Authorizations for such Other Licensed Product, * * *. The parties agree that the terms of this Agreement shall apply to such jointly developed Other Licensed Product except the parties will meet and negotiate in good faith to amend those sections of this Agreement which the parties deem appropriate, in order to establish the relationship between the parties with respect to such Other Licensed Product development and commercialization. Any regulatory filings on such Other Licensed Products will be made only if agreed to by both parties in writing. * INDICATES THAT MATERIAL HAS BEEN OMITTED AND CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2.
Other Licensed Products. All other IDE’s, PMA Applications and other Regulatory Approvals for the sale of Licensed Products during the Term of this Agreement submitted or amended after the Effective Date shall be prepared and submitted by QMS in its name.
Other Licensed Products. [****] the Parties have finalized the PRC Submission Estimated Timeline [****], in each case, such PRC Submission Estimated Timeline is included in the initial Global Development Plan. In addition, the JPT will develop a PRC Submission Estimated Timeline for any additional Licensed Products at the appropriate time. The JPT will submit each such PRC Submission Estimated Timeline to the JSC to review, discuss, and determine whether to approve.
