Commercialization Responsibility and Diligence Sample Clauses

Commercialization Responsibility and Diligence. Subject to the terms and conditions of this Agreement, and except for Assembly’s Co-Promotion rights (if exercised), Gilead will have the sole right to Commercialize (and will solely control, at its discretion, the Commercialization of), itself or with or through its Affiliates, Sublicensees, licensees or other Third Parties, the applicable Optioned Products in the Field in the Gilead Territory. For each Optioned Program for which there is an Optioned Product that has achieved Regulatory Approval, Gilead shall [***].
Sample 1
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Commercialization Responsibility and Diligence. Subject to the terms and conditions of this Agreement, Assembly will have the sole right to Commercialize (and will solely control, at its discretion, the Commercialization of), itself or with or through its Affiliates, Sublicensees, licensees or other Third Parties, the applicable Non-Optioned Gilead Products in the Field in the Territory. Except as set forth in the Gilead Third Party Obligations Schedule, for each Non-Optioned Gilead Program for which a Non-Optioned Gilead Product has obtained Regulatory Approval, Assembly shall [***]. For clarity, Assembly will comply with the applicable Commercialization diligence obligations set forth in the Gilead Third Party Obligations Schedule with respect to applicable Non-Optioned Gilead Programs. 9.4 [***].
Sample 1
Commercialization Responsibility and Diligence. (a) Each Party shall be solely responsible for all Commercialization activities and costs for Optioned Products in its Respective Territory, except as otherwise set forth in the Global Commercialization Plan and Budget and subject to the oversight of the JCC. For each Optioned Program for which there is an approved Optioned Product, Gilead shall use Commercially Reasonable Efforts to […***…]. If Gilead determines not to launch an approved Optioned Product, fails to launch an approved Optioned Product within […***…] after receipt of approval, including any required pricing approvals, or withdraws the Optioned Product, in each case for reasons other than (a) manufacturing or CMC-related issues, (b) regulatory issues or (c) other activities outside of its control, in each case in […***…] (and there are no other Optioned Products in […***…]) or […***…] (and there are no other Optioned Products in […***…]) it shall provide prompt written notice to Galapagos and Galapagos shall have a right to […***…] with respect to the applicable Optioned Program […***…], as applicable, by […***…] days’ written notice to Gilead. (b) If, during such notice period, Gilead provides Galapagos with written notice […***…] or claiming that it has launched or relaunched, as applicable, the applicable Optioned Product in […***…], as applicable, and invokes and continues to pursue in good faith the dispute resolution procedures set forth in Section 15.1(b), […***…]. During the pendency of any such dispute, all of the terms and conditions of this Agreement shall remain in effect. (c) With respect to each Optioned Program, if Gilead decides, in its sole discretion, not to Commercialize any Optioned Product for such Optioned Program in […***…], then Gilead shall notify Galapagos, and upon Galapagos’ written request, the Parties shall enter into a separate agreement that sets forth the terms pursuant to which […***…] shall become part of the Galapagos Territory for such Optioned Program (and, for clarity, […***…] shall no longer be part of the Gilead Territory for such Optioned Program) and […***…] shall be deemed a Terminated Region; provided that, such separate agreement […***…]. If the Parties do not reach agreement on the terms of any such agreement, such terms shall be determined pursuant to Section 15.1(b) and Section 15.2(a).
Sample 1
Commercialization Responsibility and Diligence. Except for Arcus’s Co-Promotion rights, if exercised, with respect to Joint Products in the Shared Territory, Gilead shall have the sole right and sole responsibility for all Commercialization activities for Optioned Products in the Gilead Territory. For each Optioned Program for which there is an approved Optioned Product, Gilead shall [***].
Sample 1
Commercialization Responsibility and Diligence 
Sample 1Sample 2

Related to Commercialization Responsibility and Diligence

  • Development Responsibilities From and after the Effective Date, BMS shall assume sole responsibility for the Development of Compounds and Products in the Field in the Territory during the Term at its own cost and expense (including responsibility for all funding, resourcing and decision-making, subject to Sections 3.3 and 3.4), except with respect to the performance by Ambrx of the Research Program activities assigned to Ambrx pursuant to the Research Plan and as otherwise may be agreed upon by the Parties in writing. BMS, by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to Develop a Compound or Product in the Field in accordance with the Development Plan for the purpose of obtaining a Regulatory Approval in each Major Market. For clarity, it is understood and acknowledged that Diligent Efforts in the Development of Compounds and Products may include sequential implementation of Clinical Trials and/or intervals between Clinical Trials for data interpretation and clinical program planning and approval.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Development Diligence Pfizer will use its Commercially Reasonable Efforts to Develop and seek Regulatory Approval for [ * ] Product [ * ] in the Field [ * ]. Pfizer will [ * ] with respect to the Development or Regulatory Approval of Products under this Agreement.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Licensee’s Responsibilities Licensee will be responsible for any and all damage to or relocation of existing facilities. Further, Licensee shall reimburse the City for all costs of replacing or repairing any property of the City, or of others, that is damaged by or on behalf of Licensee as a result of activities under this Agreement.

  • Licensee Responsibilities Licensee is responsible for Licensee’s Users’ compliance with this Agreement. Licensee is responsible for all of Licensee’s uses and accounts. Licensee will be responsible for maintaining the security of Licensee’s accounts, passwords and files. Licensee and Users cannot share Licensee’s accounts or passwords or allow any third party to use Licensee’s accounts or passwords. Licensee will exercise reasonable precautions to prevent unauthorized use of the Software.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Technical Cooperation In order to facilitate the implementation of this Agreement, developed country Members shall provide, on request and on mutually agreed terms and conditions, technical and financial cooperation in favour of developing and least-developed country Members. Such cooperation shall include assistance in the preparation of laws and regulations on the protection and enforcement of intellectual property rights as well as on the prevention of their abuse, and shall include support regarding the establishment or reinforcement of domestic offices and agencies relevant to these matters, including the training of personnel.

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