Development and Commercialization of the Products Sample Clauses

Development and Commercialization of the Products. During the Term, Novan shall use Commercially Reasonable Efforts to develop, obtain Regulatory Approval for and Commercialize the Products. Novan may elect to fulfill the foregoing obligations using its internal capabilities, through its Affiliates or by entering into Out-License Agreements. Promptly after entering into any Out-License Agreement, Novan shall provide to Xxxxx Creek notice and a copy of such Out-License Agreement. Novan may also utilize the services of Third Parties, including without limitation Third Party contract research organizations, contract manufacturing organizations, suppliers, partners and other service providers to develop, obtain Regulatory Approval and Commercialize the Products. Additionally, each Calendar Quarter until the First Commercial Sale of a Product and, thereafter, twice per Calendar Year with respect to such Product (or as more frequently reasonably requested by Xxxxx Creek), Novan will deliver to Xxxxx Creek a report summarizing its development and Commercialization activities during the prior relevant period. Each such report shall include (i) a summary of services provided by all Third Party contract research organizations, contract manufacturing organizations, suppliers, partners and other service providers; (ii) reports, summaries or other documents provided by or on behalf of Novan relating to the development of or clinical trial performance of a Product (including Phase III Clinical Trial results related to the determination of Clinical Trial Success); (iii) identification of any material Product Intellectual Property developed, created, reduced to practice or acquired by or on behalf of Novan; and (iv) copies of Novan’s business plans, financial plans, marketing plans and projections, as well as any filings or submissions to any Regulatory Authority. If an Affiliate and/or Contract Party meets or fulfills any or all of the obligations of Novan under this Agreement, and/or observes any of the terms or conditions hereof, then Novan will be deemed to have met or fulfilled such obligations or observed such terms or conditions, as the case may be.
Sample 1
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Development and Commercialization of the Products. Onconic shall provide technical support for the development and registration of the licensed products, including but not limited to preclinical studies, clinical studies, CMC studies and toxicity tests required by the NMPA or relevant regulatory authorities. The Company shall be the marketing authorization holder of the licensed products in the licensed territory, and is responsible for commercialization activities including preclinical research, clinical research, registration and application, manufacturing, marketing and promotion of the licensed products in the licensed territory.
Sample 1
Development and Commercialization of the Products. 3.1 Rezolute shall use its Commercially Reasonable Efforts to develop the Products so as to enable their registration and commercialization. In case Rezolute delays developments for a reasonable cause, Rezolute shall inform Handok of delays and the causes for such delays in developments. If Rezolute delays development of any Product for an extended period of time without a reasonable cause, whether or not such delay has been notified to Handok, both Parties shall discuss the considerations related to the Product. 3.2 Handok shall use its Commercially Reasonable Efforts to commercialize the Products in the Territory. Activities that may be carried out by Handok shall include but not be limited to preparing, submitting and maintaining (including submission of supplementary material) NDA for the Products in the Territory as the license holder, with cooperation from Rezolute. Handok shall carry out development activities required to register and commercialize the Products in the Territory, as determined by the JDC. Handok shall promptly notify Rezolute of all approvals granted with respect to the Products. All NDAs and other regulatory filings made or filed by Handok with respect to any Product shall be in the name of, and the owned solely by, Handok. 3.3 Handok shall advertise and promote the Products in the Territory in accordance with the terms of this Agreement. Handok shall have the sole discretion to manage its own commercial strategy to promote and sell the Product in the Territory. 3.4 Rezolute shall grant Handok full and exclusive rights to use the Patents in the Territory and shall provide all information and material reasonably deemed required for Handok under this Section 3. 3.5 Rezolute shall provide all reasonable support and marketing expertise specific to the Products necessary or useful for Handok in order to assist Handok in distributing, marketing, promoting and selling the Products in the Territory. Such assistance shall include, but not limited to, access to all Rezolute's available promotional materials and other published and unpublished background medical and marketing materials for the Products. Any marketing material developed independently by Handok and not based on the information or material provided by Rezolute shall be subject to review by Rezolute prior to its use.
Sample 1
Development and Commercialization of the Products 
Sample 1

Related to Development and Commercialization of the Products

  • 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).

  • 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.

  • 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.

  • Development Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones) B. Estimated total development time

  • Commercialization Plan At such times as the JGC will deem appropriate, the JGC will direct the Parties to mutually prepare a Worldwide Commercialization Plan, and the JGC will review and approve such initial Worldwide Commercialization Plan. Thereafter, the JGC will have one or the other Party (or both) update the Worldwide Commercialization Plan each calendar year, and the JGC will review and approve any such update or any other amendment to the Worldwide Commercialization Plan. Notwithstanding anything in this CCPS Agreement to the contrary, the Parties acknowledge and agree that (i) Bluebird may decline to perform any Commercialization activity proposed to be conducted by Bluebird in the Worldwide Commercialization Plan (other than Manufacturing of Vectors and associated Payloads), and (ii) the Worldwide Commercialization Plan will not include, and Bluebird will have no obligation to perform, any such Commercialization activity that Bluebird has declined to perform, provided that once Bluebird has agreed to perform a Commercialization activity, it will be obligated to perform, and cannot decline to perform, such activity. In addition, either Party may request at any time that the JGC consider and approve other updates to the Worldwide Commercialization Plan. Further: (a) The JGC will set the required form and contents of the Worldwide Commercialization Plan. The Worldwide Commercialization Plan will reflect a singular marketing and sales approach worldwide, and will specify, among other things, the number of sales reps in the U.S. for each Party, allocation of regions in the U.S. for each Parties’ sales force, creation of marketing materials, planning for conferences, and other marketing activities. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (b) Neither Party (itself or by or through any others, including any Affiliates or Sublicensees) will take any material action regarding the Commercialization of Licensed Product unless described in the Worldwide Commercialization Plan or approved by the JGC. (c) All Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision of the JGC and as part of the U.S. Development & Commercialization Program. (d) Celgene will have final decision making authority for all Commercialization activities worldwide, including timing of launch and pricing and the Worldwide Development Plan.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Research Program The term “

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.

  • Collaboration 31.1 If the Buyer has specified in the Order Form that it requires the Supplier to enter into a Collaboration Agreement, the Supplier must give the Buyer an executed Collaboration Agreement before the Start date. 31.2 In addition to any obligations under the Collaboration Agreement, the Supplier must: 31.2.1 work proactively and in good faith with each of the Buyer’s contractors 31.2.2 co-operate and share information with the Buyer’s contractors to enable the efficient operation of the Buyer’s ICT services and G-Cloud Services

  • 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.

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