Diligence; Development and Commercialization Clause Samples

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Diligence; Development and Commercialization. INDEVUS shall use commercially reasonable efforts to develop and commercialize Product. As used herein, "commercially reasonable efforts" shall mean efforts and resources normally used by INDEVUS for a product owned by it or to which it has exclusive rights, which is of similar market potential at a similar stage in its development or product life, taking into account issues of safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory and reimbursement structure involved, the profitability of the applicable products, and other relevant factors. The obligations set forth in this Section 3.2 are expressly conditioned upon the absence of any serious adverse conditions or event relating to the safety or efficacy of Compound or Product including the absence of any action by any regulatory authority limiting the development or commercialization of Compound or Product.
Diligence; Development and Commercialization. 3.2.1 ARCA shall use commercially reasonable efforts to develop and commercialize Product. As used herein, “commercially reasonable efforts” shall mean efforts and resources normally used by a pharmaceutical company for a product to which it has rights similar to those granted hereunder, which is of similar market potential at a similar stage in its development or product life, taking into account issues of safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory and reimbursement structure involved, the profitability of the applicable products, and other relevant factors. 3.2.2 In addition to the diligence obligations set forth in Section 3.2.1 above, ARCA shall also: (a) [ * ] within [ * ] of the Effective Date; and (b) Receive an Institutional Review Board (“IRB”) approval of the protocol for a Phase 3 clinical trial with Product (after an End of Phase 2 Meeting) in patients with congestive heart failure within [ * ] after the Effective Date and commence such Phase 3 clinical trial within [ * ] after such IRB approval, and have raised sufficient financing to complete such trial prior to its commencement. [*] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.
Diligence; Development and Commercialization. Each Party shall use reasonable efforts consistent with prudent business judgment in the development and commercialization of Products in any of its exclusive Fields.
Diligence; Development and Commercialization. Acuity shall use Commercially Reasonable Efforts to develop and commercialize the Licensed Product. The obligations set forth in this Section 2.4 are expressly conditioned upon the absence of any serious adverse conditions or event relating to the safety or efficacy of the Technology or Product including the absence of any action by any regulatory authority limiting the development or commercialization of the Technology or Product.
Diligence; Development and Commercialization. Novexel shall use commercially reasonable efforts to develop and commercialize Product. As used herein, “commercially reasonable efforts” shall mean efforts and resources normally used by Novexel for a product owned by it or to which it has exclusive rights, which is of similar market potential at a similar stage in its development or product life, taking into account issues of safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory and reimbursement structure involved, the profitability of the concerned products, and other relevant factors if any.
Diligence; Development and Commercialization. Interneuron shall use -------------------------------------------- commercially reasonable efforts to develop and commercialize Product. As used herein, "commercially
Diligence; Development and Commercialization. Interneuron shall use commercially reasonable efforts to develop and commercialize Product. As used herein, "commercially reasonable efforts" shall mean efforts and resources normally used by Interneuron for a product owned by it or to which it has exclusive rights, which is of similar market potential at a similar stage in its development or product life, taking into account issues of safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory and reimbursement structure involved, the profitability of the applicable products, and other relevant factors. Interneuron will be responsible for all remaining preclinical development, toxicology and clinical development, including regulatory filings, which are required for commercialization of Product in the Territory. Interneuron shall notify HDCI upon the receipt of regulatory approvals and of the date of First Commercial Sale. Except as specifically set forth in Schedule 3.7 hereof, Interneuron shall be responsible for all costs attributable to the development and commercialization of Compound and Product which are incurred after the Effective Date; provided that with respect to agreements entered into by HDCI relating to Compound or Product prior to the Effective Date, Interneuron shall be responsible only for the costs under those agreements referred to in Schedule 3.7 hereof.
Diligence; Development and Commercialization. Interneuron shall use -------------------------------------------- commercially reasonable efforts to develop and commercialize Product, including the preparation and filing of regulatory submissions. As used herein, "commercially reasonable efforts" shall mean efforts and resources normally used by Interneuron for a product owned by it or to which it has exclusive rights, which is of similar market potential at a similar stage in its development or product life, taking into account issues of safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory and reimbursement structure involved, the profitability of the applicable products, and other relevant factors.
Diligence; Development and Commercialization. MEDICINOVA shall use commercially reasonable efforts to develop and commercialize Product, including the preparation and filing of regulatory submissions. As used herein, “commercially reasonable efforts” shall mean efforts and resources normally used by MEDICINOVA for a product owned by it or to which it has exclusive rights, which is of similar market potential at a similar stage in its development or product life, taking into account issues of safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory and reimbursement structure involved, the profitability of the applicable products, and other relevant factors. The obligations set forth in this Section 3.2 are expressly conditioned upon the absence of any serious adverse conditions relating to the safety or efficacy of ** CERTAIN INFORMATION (INDICATED BY ASTERISKS) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. AN UNREDACTED VERSION OF THIS DOCUMENT HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. Compound or Product including the absence of any action by any regulatory authority limiting the development or commercialization of Compound or Product.
Diligence; Development and Commercialization. (A) After the Effective Date, Warner will be responsible for conducting and fully funding all Development, regulatory filings, and Commercialization of the Licensed Products. Warner shall only be obligated to develop or commercialize the Licensed Products using not less than those efforts Warner applies with respect to its other drug candidates and pharmaceutical products of a comparable stage of development and commercial potential. Warner shall not be obligated to pursue Development or Commercialization in any specific jurisdiction. Interneuron's only remedy in the event Warner fails to fulfill the obligation set forth in the second sentence of this Section 3.7 shall be to terminate this License Agreement under Section 8.3 and require Warner to provide Interneuron with all samples of the Licensed Product. Warner shall comply with all applicable laws and regulations in the Commercialization of Licensed Products. No more than twice per calendar year, Interneuron may request a meeting with Warner to discuss a summary of the progress and results of Warner's Development and Commercialization at dates and locations to be mutually agreed to. Any disclosures of such progress and results shall be deemed Confidential Information of Warner. Warner shall also notify Interneuron as soon as reasonably practicable upon the achievement of milestones listed in 4.1(a) below, the receipt of Regulatory Approvals in the United States, Japan and Europe, and the date of First Commercial Sale in the United States, Japan and Europe. (B) In addition to and not in lieu of the obligations of Warner under the second sentence of Section 3.7(a), Warner shall: 1. Either dose the first patient in a Phase III Clinical Trial for Panic Disorder by the 12 month anniversary of the date this Agreement is fully signed by authorized representatives of each Party or pay to Interneuron the amount set forth in Section 4.2(a)(1) (which payment shall be deemed to be in lieu of the obligation to make such payment under Section 4.2(a)); and 2. Either dose the first patient in a Phase II Clinical Trial for General Anxiety Disorder by the 12 month anniversary of the date this Agreement is fully signed by authorized representatives of each party, or pay to Interneuron $* dollars by such twelve month anniversary (which payment shall be credited against any milestone payments due under Section 4.2(a)(2)); and 3. Either dose the first patient in a Phase III Clinical Trial for General Anxiety Disorder by the...