Regulatory, Manufacturing and Commercialization. After the Effective Date, # Zai Lab will be solely responsible for and control (at its own expense) all regulatory matters related to the Development and Commercialization of Compounds and/or Products in the Territory, including, without limitation, taking full responsibility for preparing and filing the relevant applications with the Regulatory Authorities for pre-clinical and clinical studies and for Regulatory Approval; and # Zai Lab will be solely responsible for and control (at its own expense) all aspects of Commercialization of Products and the Manufacturing and supply of Products (including, without limitation, the Manufacture and supply of related Compounds being Developed by Zai Lab) in the Territory and will have sole responsibility for all costs arising therefrom.
Subsequent Manufacturing Technology Transfer. Without limiting the foregoing or the licenses and other rights granted by each Party to the other under this Agreement, in the event that # any Allergan RTGel Improvement is made by or on behalf of Allergan or any of its Affiliates or # any RTGel Improvement is made by or on behalf of UroGen or any of its Affiliates, in each case relating to, or that is otherwise necessary or useful for, the Manufacture of the RTGel Product during the Term (New Manufacturing Technology), such Party shall promptly disclose such New Manufacturing Technology to the other Party and shall, at the other Partys request, perform technology transfer with respect to such New Manufacturing Technology in the same manner as provided in [Section 5.2] (applied mutatis mutandis to Allergan, as applicable).
“Transactional Agreements” shall mean: # the Agreement; # the Bill of Sale and Assumption Agreement; # the IP Assignment Agreements; # the Manufacturing and Supply Agreement; and # the Transition Services Agreement.
“Permitted Facility” or “Permitted Facilities” or “Permitted Use” means a pharmaceutical services, development, and manufacturing facility, all related purposes such as ingress, egress and parking, and uses incidental thereto.
Time Estimates. Due to the unpredictable nature of the Development Services, the time schedule set down for the performance of these Services in a Work Order is an estimate only. Upon completion or near completion of early-phase program elements, the project teams will establish a more definitive time schedule estimate for Manufacturing Services.
Transition Services; Reverse Termination Services. Following the Closing Date, # Purchaser may request that any Seller or its Affiliate(s) provide transition services on customary terms and duration mutually agreed upon among the Parties and # any Seller(s) may
“cGMP” means the current Good Manufacturing Practices and General Biologics Products Standards as promulgated under the US Federal Food Drug and Cosmetic Act at 21 CFR (Chapters 210, 211, 600 and 610), the Guide to Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 91/356/EEC and ICH Guidance (Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients that are applicable to the Services. WuXi ATU’s operational quality standards are defined in internal GMP policy documents.
Consulting Services. During the "Consulting Period" (as defined below), will stand ready and will furnish to ITW such reasonable services of an advisory or consulting nature with respect to its business and affairs as ITW may reasonably call upon Service to furnish, with the parties' understanding that: # will be available for the Consulting Period upon reasonable notice and at reasonable times for periodic consultations, either in person, by videoconference, or by telephone; and # Mr. Martindale will not be an employee of ITW in performing consulting services hereunder, but he and will act in the capacity of independent contractor. The parties contemplate that the services provided by will be limited to an approximate total of four days per month. The "Consulting Period" means the period beginning and continuing until either party provides 30 days' written notice of termination of the Agreement. Either party may provide such notice at any time for any reason.
Hospital Services. Employer and Employee acknowledge that, as of the date hereof, Employer does not currently operate hospitals, hospital systems or universities. Nevertheless, the businesses of hospitals, hospital systems and universities would be the same as Employer’s Business where such hospitals, hospital systems or universities provide or contract with others to provide some or all of the medical services included in Employer’s Business. Therefore, the parties desire to clarify their intent with respect to the limitations on Employee’s ability to work for or contract with others to provide services for a hospital, hospital system or university during the Employment Period and during the Restricted Period. [Section 8.1] shall not be deemed to restrict Employee’s ability to work for a hospital, hospital system or university if the hospital, hospital system or university does not provide any of the medical services included in Employer’s Business. Furthermore, even if a hospital, hospital system or university provides medical services that are included in Employer’s Business, Employee may work for such hospital, hospital system or university if Employee has no direct supervisory responsibility for or involvement in the hospital’s, hospital system’s or university’s provision of medical services that are Employer’s Business. For the avoidance of doubt, Employer and Employee agree that if Employee becomes the Chief Operating Officer, Chief Legal Officer, Chief Compliance Officer, General Counsel or Chief Executive Officer of a hospital system or health system, or other executive officer of similar level to the foregoing, that Employee shall not be in breach of the provisions of this Agreement. Finally, Employer agrees that Employee may hold direct supervisory responsibility for or be involved in the medical services of a hospital, hospital system or university that are included in Employer’s Business so long as such hospital, hospital system or university is located at least ten (10) miles from a medical practice owned or operated by Employer or its affiliate. Subject to paragraph B below, the provisions of this paragraph shall not apply to the extent that, after the date hereof, Employer enters into the business of operating a hospital or hospital system.
Exclusive Services. Executive shall at all times faithfully, industriously and to the best of his or her ability, experience and talent perform to the satisfaction of the Chief Executive Officer or the Board all of the duties that may be assigned to Executive hereunder and shall devote substantially all of his or her productive time and efforts to the performance of such duties. Subject to the terms of the Proprietary Information and Inventions Agreement referred to in [Section 5(b)], this shall not preclude Executive from devoting time to personal and family investments or serving on community and civic boards, or participating in industry associations, provided such activities do not interfere with his or her duties to the Company, as determined in good faith by the Chief Executive Officer or the Board. Executive agrees that he or she will not join any boards, other than community and civic boards (which do not interfere with his or her duties to the Company), without the prior approval of the Chief Executive Officer or the Board.
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