Global Coordination Sample Clauses

Global Coordination. Alexza agrees and acknowledges that it is in the Parties’ mutual interests to coordinate on a global basis the development, regulation, manufacturing, publication and commercialization of the Product. To facilitate such coordination, at least once each [ * ] during the Term, representatives from Teva, Alexza and Alexza’s Affiliates the Field and/or outside the U.S. shall meet to discuss matters related to the development, regulation, manufacturing, publication and commercialization of the Product on a global basis. Alexza’s licensees shall also be invited by Alexza to any such meetings in an effort to facilitate the coordination of such activities among Teva, Alexza and Alexza’s Affiliates and licensees. The location of such meetings shall rotate among locations designated by Teva and Alexza. In addition to these [ * ] meetings, Alexza shall keep Teva informed, through the JSC, as to the efforts of Alexza or its Affiliates or licensees in developing and commercializing the Product for use outside the Field and/or the U.S., and Alexza shall use reasonable efforts to share and discuss information regarding such efforts prior to Alexza or its Affiliates or licensees taking any actions related thereto. Any such disclosures shall be subject to Alexza’s obligations with its Third Party licensee(s) to maintain the confidentiality of such information, provided that any such information shall be deemed Alexza’s Confidential Information hereunder.

Global Coordination. LICENSEE will reasonably cooperate with Council and Council’s other licensees of Nestorone®-containing products other than the Licensed Product with respect to safety, and pharmacovigilance, and will enter into one or more safety and pharmacovigilance agreements as may be necessary or useful to effect such cooperation, and Council will require its other licensees of Nestorone®-containing products other than the Licensed Product to cooperate with LICENSEE, or its permitted sublicensees, as the case may be, with respect to safety and pharmacovigilance, including safety data.

Global Coordination. 12.1 Ardana will have consultative rights in relation to the global strategy for regulatory affairs, Product development, clinical development and for the manufacturing and marketing of the Product throughout the world. Each Party will, and Senetek will ensure that each of its licensees, agents and distributors for the Product: 12.1.1 keep the other Party fully informed and consult with the other Party on an ongoing basis in relation to the actions they propose to take in relation to regulatory affairs, Product development (including, but not limited to, proposed studies and clinical trials in relation to the Product and the Delivery System) and the manufacturing and marketing, of the Product; and 12.1.2 take account of the other Party’s comments in relation to regulatory affairs, Product development and the manufacturing and marketing, of the Product. For the avoidance of doubt, the Parties will not share information in relation to the commercial terms of sale of the Product and/or the Delivery System including, but not limited to, sale price (whether by a Party or its sub-licensees). 12.2 The parties shall establish a joint coordinating committee (“JCC”) which shall be responsible for coordination of a global strategy for regulatory affairs, clinical development, Product Development and the manufacturing and marketing of the Product (whether in conjunction with the Delivery System or otherwise) throughout the world. 12.3 The JCC shall be comprised of five (5) appropriately qualified representatives of the parties, three (3) of whom shall be appointed by Ardana and two (2) of whom shall be appointed by Senetek. Ardana’s appointees shall be ▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇ ▇▇▇▇▇▇ and ▇▇▇ ▇▇▇▇▇▇▇▇, or such other persons as Ardana may nominate from time to time. Senetek’s appointees shall be ▇▇▇▇▇ ▇▇▇▇▇▇▇ and ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, or such other persons as Senetek may nominate from time to time. The chairperson of the JCC shall be ▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇,

Global Coordination. 10.1 Plethora acknowledges that pursuant to the Ardana Licence Agreement Senetek and Ardana have formed a joint coordinating committee (“JCC”) responsible for coordination of a global strategy for regulatory affairs, clinical development, Product Development and the manufacturing and marketing of the Product (whether in conjunction with the Delivery System or otherwise) throughout the world. Plethora agrees to join the JCC, which thereupon (until such time, if any, as a third party licensee may join the JCC) will be comprised of up to seven (7) appropriately qualified representatives of the parties, three (3) of whom shall be appointed by Ardana, two (2) of whom shall be appointed by Plethora and two (2) of whom shall be appointed by Senetek. The chairperson of the JCC will be ▇▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, or if ▇▇ ▇▇▇▇▇▇▇ is not available to attend any meeting of the JCC, such of the JCC’s other nominated members as a majority of the members in attendance may appoint. The JCC is entitled to invite to each of its meetings such additional representatives or external advisers as may be necessary or desirable to fulfil the responsibilities of the JCC. The JCC is to convene not less than twice each Calendar Year on dates and at times, and in locations or by teleconferencing, to be agreed between the members of the JCC. Each party is to bear its own costs in relation to participation of its members at meetings of the JCC. 10.1.1 keep the other Party fully informed and consult with the other Party on an ongoing basis in relation to the actions they propose to take in relation to regulatory affairs, Product development (including, but not limited to, proposed studies and clinical trials in relation to the Product and the Delivery System) and the manufacturing and marketing, of the Product; and 10.1.2 take account of the other Party’s comments in relation to regulatory affairs, Product development and the manufacturing and marketing, of the Product. For the avoidance of doubt, the Parties will not share information in relation to the commercial terms of sale of the Product and/or the Delivery System including, but not limited to, sale price (whether by a Party or its sub-licensees).

Global Coordination. In addition to meetings of the JDC, representatives of the Parties will meet periodically to ensure that the clinical and regulatory activities and strategy are consistent on a global basis. Both Parties will provide input into the global regulatory strategy, will review all significant Regulatory Filings prior to submission to Regulatory Authorities, will receive copies of all correspondence from Regulatory Authorities in a timely manner, and will have the right to attend all Regulatory Authority meetings/interactions in the U.S. Territory or with the EMEA or the Regulatory Authorities in any European Country or in Japan. The Party that is the Responsible Party may schedule meetings with such Regulatory Authorities and shall give the other Party as much notice as is practicable of such meetings.

Global Coordination. Each Party will use Commercially Reasonable Efforts to include in any Third Party Collaboration Agreement a good faith obligation on such Third Party Partner to participate in discussions with AVEO and CANbridge at least annually to facilitate information sharing and the global coordination of the Development, Manufacture and Commercialization of Products.

Global Coordination