Market Launch Sample Clauses

Market Launch. For each CoSeal Unit under this Distribution and License Agreement that has not received Regulatory Approval in a country within the Territory as of the Effective Date, and wherein the corresponding Commercialization Plan sets forth Xxxxxx’x intent to commercialize such CoSeal Unit in such country, Xxxxxx shall use Commercially Reasonable Efforts to effect the first commercial sale of each such CoSeal Unit in such country as soon as reasonably practicable, but with the goal of making such sale no later than six (6) months after receiving Regulatory Approval for such CoSeal Unit in such country. Notwithstanding the foregoing, if Xxxxxx reasonably determines that there exists a reason(s) (for example, poor market conditions, regulatory change, safety concerns, or other events affecting commercial feasibility) to delay the market launch of such CoSeal Unit(s), Xxxxxx shall submit such reason(s) to AAC for its consent to the delay, which consent shall not be unreasonably withheld or delayed. Should AAC disagree with Xxxxxx’x determination and reason(s), AAC shall submit its and Xxxxxx’x findings to the Program Directors, who shall resolve the issue in compliance with Section 3.1. Notwithstanding the foregoing, in the event that Xxxxxx’x delay in making the first commercial sale is due to an event that would serve as a basis for a recall or field corrective action pursuant to Section 5.4 of the Manufacturing Agreement, then Xxxxxx may unilaterally delay such market launch, and in such event only notice to AAC, and not AAC’s consent, shall be required. The obligations under this Section 8.3(a) shall apply on a country-by-country basis as and when such country is specifically set forth in a Commercialization Plan. Nothing in this Section 8.3(a) shall impose upon Xxxxxx the obligation to conduct a market launch in any country where it has received Regulatory Approval on a regional basis (for example, a European CE xxxx approval).
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Market Launch. The Commercializing Party shall use Reasonable Commercial Efforts to seek marketing authorizations in Major Market Countries and effect the introduction of Product into Major Market Countries within [*] of such Product completing the Regulatory Approval process..
Sample 1
Market Launch. During the term of their respective licenses granted under Section 2.1, each of BSC and Cook agrees to commit a minimum of $1,000,000 in direct marketing and xxxes expenses for Eligible Products that incorporate Angiotech Technology (subject to reduction pursuant to Sections 5.1 and 5.2).
Sample 1
Market Launch. Distributor shall use best efforts to distribute the Product in the Territory in accordance with the Marketing Plan. In accordance with the Marketing Plan, Distributor shall collaborate with Osiris with respect to its market launch activities with surgeons and shall allow Osiris to offer input regarding these activities. Notwithstanding the foregoing, Distributor shall submit or arrange to be submitted to Osiris, for Osiris’ written approval prior to release, any advertising, public relations material, technical descriptions or Product claims, whether oral, written or electronic, prepared by or for Distributor or any customers which THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH A “*” AND BRACKETS AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. discuss, mention or make reference to the Product or use or bear an Osiris trade name, logo or trademarks, including, without limitation, Osteocel and Osiris (collectively, the “Xxxxxx Xxxxx”). If Osiris provides Distributor with any update, enhancement, or modification to an Osiris Xxxx, Distributor shall use commercially reasonable efforts to incorporate the updated, enhanced, or modified Osiris Xxxx in all subsequent materials that are produced by or for Distributor.
Sample 1
Market Launch. 8 2.4 Delay of Market Launch...................................................................... 8 2.5 Market Launch [**].......................................................................... 8
Sample 1
Market Launch. CPC shall use commercially reasonable efforts to consummate a First Commercial Sale of the Initial Device within the launch schedules set out on Schedule 2.3 (the "Launch Deadline").
Sample 1
Market Launch. In connection with the introduction of the Products into new markets, Distributor shall collaborate with Company with respect to its market launch activities with physicians and shall allow Company to offer input regarding these activities. Notwithstanding the foregoing, Distributor shall submit or arrange to be submitted to Company, for its written approval prior to release, any advertising, public relations material, technical descriptions, or Product claims, whether oral, written, or electronic, prepared by or for Distributor or any customers which discuss, mention, or make reference to the Product or use or bear a Company Xxxx. If Company provides Distributor with any update, enhancement, or modification to a Company Xxxx, Distributor shall use commercially reasonable efforts to incorporate the updated, enhanced, or modified Company Xxxx in all subsequent materials that are produced by or for Distributor.
Sample 1
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Related to Market Launch

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • REGULATORY EVENT If a Regulatory Event occurs, the Parties shall use their best efforts to reform this ESA to give effect to the original intent of the Parties. If a Regulatory Event affects Competitive Supplier and Competitive Supplier incurs excess costs as a result thereof, such amount shall be allocated to and collected from Participating Consumers on a per kWh basis through applicable monthly invoice(s).

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • Market Activities The Company will not, directly or indirectly, (i) take any action designed to cause or result in, or that constitutes or would reasonably be expected to constitute, the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of Common Stock or (ii) sell, bid for, or purchase Common Stock in violation of Regulation M, or pay anyone any compensation for soliciting purchases of the Placement Shares other than the Agent.

  • 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.

  • Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.

  • 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.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • 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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