Commercialization Reports. Each Party will keep the JCC fully informed regarding the progress and results of Commercialization activities for Products in the Shared Territory, including an annual review of results versus goals (as such goals are set forth in the Joint Commercialization Plan(s)). SGI will provide on a quarterly basis a rolling annual forecast of projected sales for Products in the Licensed Territory. The Parties will work together to provide such forecast for Products in the Shared Territory. With respect to any Reversion Product, the Continuing Party will update the Opt-Out Party, through the JCC, regarding the progress of Commercialization of such Reversion Product, on no less than an annual basis.
Commercialization. By of each calendar year during the Term, the Continuing Party will provide to the other Party a report on the Commercialization of the applicable Reversion Product. Such report will describe in reasonable detail the Commercialization efforts for the preceding calendar year for such Reversion Product (including the past calendar year and projected budgets for such Commercialization). Further, the Continuing Party will provide such additional information regarding the Commercialization of such Reversion Product as the other Party may reasonably request, and further will meet (in person at the Continuing Partys site) with such other Party after providing such report upon such other Partys request to discuss same. Subject to Applicable Law, all Pricing Matters for Reversion Products will be determined by the Continuing Party, except to the extent they constitute an ACTR Matter, in which event such Pricing Matter will be determined by mutual agreement of the JSC, subject to the dispute resolution process set forth in [Section 4.5(c)]. The Parties will comply with [Section 7.3] for each Reversion Product, with the Continuing Party being responsible for the global safety database for such Reversion Product.
Commercialization. In connection with this Agreement and the rights granted hereunder,
Commercialization. Licensee shall promptly give Merck written notice that it has filed an NDA for the Licensed Product and at that time shall further provide Merck with the anticipated date of First Commercial Sale for the Licensed Product in the country of filing. Licensee shall promptly provide Merck with notice of any Marketing Authorization of Licensed Product.
The Parties will share the Joint Commercialization Costs fifty percent/fifty percent, provided that if any information or data generated by any Voluntary Phase 4 Clinical Trial approved by the JSC and included in the Joint Commercialization Plan is used in the Licensed Territory, Unum will be responsible for and SGI will be responsible for of all Joint Commercialization Costs associated with such Voluntary Phase 4 Clinical Trial and, for clarity, as between the Parties, SGI may freely use such information or data in the Licensed Territory. Notwithstanding the amounts allocated to Commercialization activities in the Shared Territory in the applicable Joint Commercialization Budget, for any calendar year, each Party will only be permitted to recover Joint Commercialization Costs with respect to Commercialization activities that have been allocated to such Party under the Joint Commercialization Plan and
Exclusive Commercialization. Subject to the terms and conditions of this Agreement, and effective as of the completion of the Closing as set forth in the Strategic Alliance Agreement, TLC grants TLC Hong Kong the exclusive and fully paid right to Commercialize the TLC Products in the China Territory. TLC hereby confirms that if any counterparty to a drug commercialization agreement or similar contract with TLC Group engages in the Commercialization of any TLC Products in the China Territory, or any sales of TLC Products into the China Territory, such engagement will be deemed a violation of its contract with TLC Group and TLC will (and will procure other members of the TLC Group to) enforce its contractual rights against such counterparty.
On an annual basis, ACADIA shall prepare a Commercialization plan with respect to the Commercialization of each Product in the Field in the Territory pursuant to this Agreement (as may be amended by ACADIA, the “Commercialization Plan”). The Commercialization Plan for the first full year following commercial launch of the first Product for which an NDA is filed with the FDA will be provided to Neuren by ACADIA as soon as it is available but, in any event, no later than [……] days after the filing of the NDA for such Product with the FDA. Such initial Commercialization Plan shall provide a reasonably detailed plan for ACADIA’s (or its Affiliate’s or Sub-Licensee’s) Commercialization activities with respect to such Product, including pre-launch plans and launch plans, pricing, label expansion and market positioning (which information may be preliminary). ACADIA may amend the Commercialization Plan from time to time in its discretion.
Without limiting any other provision of this Agreement ACADIA (or its Affiliate or Sub-Licensee, as applicable) shall be solely responsible for:
Annual Reports; Etc. Promptly after the same are required to be delivered or may be available, as the context requires, copies of each annual report, proxy or financial statement or other report or communication sent to the stockholders of the , and copies of all annual, regular, periodic and special reports and registration statements which the may file or be required to file with the SEC under Section 13 or 15(d) of the Securities Exchange Act of 1934, or with any national securities exchange, and in any case not otherwise required to be delivered to the pursuant hereto.
Reporting. Spero shall provide to Northern a written report for each calendar quarter, which shall adequately describe the status of the development and commercialization of the Licensed Compounds and Licensed Products (including for the avoidance of doubt any Combination Product), including at a minimum: results and data of any clinical or non-clinical studies and . All such reports and their contents shall constitute Confidential Information of Spero.
No later than prior to the projected NDA filing date for a Product in the Shared Territory, the JCC will prepare and recommend to the JSC for approval an initial Joint Commercialization Plan for each Product (including the initial Joint Commercialization Budget). Subject to [Section 8.3(c)], each Joint Commercialization Plan will allocate the Co-Promotion responsibilities of the Parties in an equitable fashion taking into account the Parties respective capabilities. For clarity, SGI will be responsible for all Commercialization activities in the Licensed Territory, and such activities will not be included in the Joint Commercialization Plan. All Joint Commercialization Plans, including the corresponding Joint Commercialization Budgets, with respect to each Product in the Shared Territory and subsequent revisions thereto will contain such information as the JCC believes necessary for the successful Commercialization of such Product in the Shared Territory, both pre- and post-launch, and will generally conform to the level of detail utilized by the Lead Commercializing Party in preparation of its own product Commercialization plans. On an annual basis, or more often as the Parties deem appropriate, the JCC will prepare amendments to the then-current Joint Commercialization Plan(s), including the corresponding Joint Commercialization Budgets. In the event of any inconsistency between a Joint Commercialization Plan and this Agreement, the terms of this Agreement will prevail. Each Party will conduct its activities under the Joint Commercialization Plan(s) in compliance in all material respects with Applicable Law.
Segregate means, with respect to an Alternative Product, to use diligent efforts to segregate the research, development, manufacture and commercialization activities relating to such Alternative Product from Research, Development, Manufacture and Commercialization with respect to any Research Candidates, Development Candidates or Products under this Agreement, including using diligent efforts to ensure that: # no personnel involved in performing the research, development, manufacture or commercialization of such Alternative Product have relating to the Research, Development, Manufacture or Commercialization of any Research Candidates, Development Candidates or Products (provided that may regarding the Research, Development, Manufacture and Commercialization of any Research Candidates, Development Candidates or Products in connection with ); and # no personnel involved in performing the Research, Development, Manufacture or Commercialization of any Research Candidates, Development Candidates or Products have access to relating to the research, development, manufacture or commercialization of such Alternative Product (provided that may regarding the research, development, manufacture and commercialization of such Alternative Product in connection with ).
Commercialization [ ]. When used as a verb, to Commercialize and Commercializing means to engage in Commercialization, and Commercialized has a corresponding meaning.
Record Keeping and Reports. Zai Lab will prepare and maintain, and will cause each of its Affiliates and any licensees or sublicensees to prepare and maintain, appropriate records (in accordance with its standard policies and procedures) regarding the Development and Commercialization of Compounds and/or Products. During the Term hereof, Zai Lab will provide GSK with annual reports setting forth # a summary of updated development progress and achievements of such Development and Commercialization tasks as set forth in the Development Plan and a listing of any Regulatory Approvals achieved for Products in the Territory, (ii), information relating to any Zai Labs sublicensing under or assignment of this Agreement. Upon GSKs request at any time during the Term hereof, Zai Lab shall provide to GSK a complete list of its licensees and sublicensees of Transferred Know-How and Licensed Patents, as well as a true and complete copy of each license agreement and sublicense agreement (as the case may be) and each amendments thereto within three (3) days after the notification. Any and all such reports (and all data and information set forth therein), lists and agreements shall be considered Zai Labs Confidential Information and shall be subject to the confidentiality and use restrictions under this Agreement.
As soon as reasonably practicable but in no case later than [……] days of the Commencement Date, the parties shall enter into a global pharmacovigilance agreement (“PVA”) setting forth details with respect to the management of safety information including adverse events reports related to the Development and the Commercialization of the Products as well as a Safety Governance Structure and provisions ensuring Neuren has full rights of access to all such information and data.
Commercialization shall mean, with respect to Licensed Product, any and all activities directed to the marketing, promotion, distribution, offering for sale and selling such product, importing and exporting such product for sale, and interacting with Regulatory Authorities regarding the foregoing. Commercialization shall also include Commercialization Studies. Commercialize has a correlative meaning.
Environmental Reports; Clean-Up. If any written report, including any report containing results of any Environmental Assessment (an "Environmental Report") shall indicate # the presence of any Hazardous Materials as to which Tenant has a removal or remediation obligation under this [Section 5.3], and # that as a result of same, the investigation, characterization, monitoring, assessment, repair, closure, remediation, removal, or other clean-up (the "Clean-up") of any Hazardous Materials is required, Tenant shall immediately prepare and submit to Landlord within thirty (30) days after receipt of the Environmental Report a comprehensive plan, subject to Landlord’s written approval, specifying the actions to be taken by Tenant to perform the Clean-up so that the Premises are restored to the conditions required by this Lease. Upon Landlord’s approval of the Clean-up plan, Tenant shall, at Tenant’s sole cost and expense, without limitation on any rights and remedies of Landlord under this Lease, immediately implement such plan with a consultant reasonably acceptable to Landlord and proceed to Clean-Up Hazardous Materials in accordance with all applicable laws. If, within thirty (30) days after receiving a copy of such Environmental Report, Tenant fails either # to complete such Clean-up, or # with respect to any Clean-up that cannot be completed within such thirty-day period, fails to proceed with diligence to prepare the Clean-up plan and complete the Clean-up as promptly as practicable, then Landlord shall have the right, but not the obligation, and without waiving any other rights under this Lease, to carry out any Clean-up recommended by the Environmental Report or required by any governmental authority having jurisdiction over the Premises, and recover all of the costs and expenses thereof from Tenant as Additional Rent, payable within ten (10) days after receipt of written demand therefor.
Copies of Environmental Reports. Within thirty (30) days of receipt thereof, Tenant shall provide Landlord with a copy of any and all environmental assessments, audits, studies and reports regarding Tenant’s activities with respect to the Premises, or ground water beneath the Land, or the environmental condition or Clean-up thereof. Tenant shall be obligated to provide Landlord with a copy of such materials without regard to whether such materials are generated by Tenant or prepared for Tenant, or how Tenant comes into possession of such materials.
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