Development of Additional Indications Sample Clauses

Development of Additional Indications. Orion may continue to Develop Dexmedetomidine in Licensed Dosage Forms (a) for uses and indications other than the Field, and (b) for use in Licensed Dosage Form combination products in the Field THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. (“Additional Products”), at Orion’s sole expense and anywhere in the world. Notwithstanding the above, Orion shall not undertake Development activities in the United States, Australia or South Africa (provided such countries remain part of the Recro Territory) with respect to products for use in Licensed Dosage Form in the Field until four (4) years have lapsed since the grant of Regulatory Approval in the United States for the first Recro Product. Licensee shall have a right of first refusal to Commercialize each Additional Product in the Recro Territory in accordance with and subject to the terms of this Section 8.4. Licensee shall have ninety (90) days to consider any proposal of commercial terms by Orion. Licensee shall notify Orion in writing if it is interested in pursuing such proposal for any or all of the Additional Products described in such proposal. In such event, the Parties shall negotiate in good faith with a view to reaching a mutually acceptable agreement (if any) for such Additional Products, which negotiations shall include without limitation, meetings by phone at least twice monthly and in person at least monthly and meeting of senior management in person at least twice during the negotiation period. If the Parties, despite conducting good faith negotiations, do not finalize and execute a mutually acceptable binding agreement for such Additional Products within one hundred eighty (180) days after the date of Licensee’s notification of interest, Orion shall be free to enter into an agreement with a Third Party with respect to such Additional Products provided such agreement does not conflict with the rights granted to Licensee under this Agreement. For the avoidance of doubt it is expressly stated that nothing herein shall be deemed as to grant Licensee any negotiation or other rights in respect of any Dexmedetomidine Product in formulation(s) other than Licensed Dosage Forms, or to any Dexmedetomidine Product in a Licensed Dosage Form outside Recro Territory.
Sample 1
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Development of Additional Indications. At any time during the Term, Aradigm may submit to Grifols, or Grifols may request that Aradigm submit (in which case Aradigm shall so submit, promptly) proposed Development plans (each, an “Additional Development Plan”) for the Development of Aradigm Products for Additional Indications, with such proposed Additional Development Plan detailing proposed Development costs for such proposed Development activities. Upon receipt (or agreement by the Parties on a form, it being agreed and understood that each Party shall in good faith take into consideration the comments of the other Party) of any such Additional Development Plan, Grifols may, in its sole discretion, elect whether to pursue the Development of such Additional Indication.
Sample 1
Development of Additional Indications. If Isis decides to request Bayer to Develop and Commercialize an Additional Indication for ISIS-FXIRx that Bayer is not then currently Developing or Commercializing, Isis and Bayer shall discuss such request in good faith and either Party shall have the opportunity to conduct the commercially reasonable analysis to decide if the Development and Commercialization of such Additional Indication shall be pursued. If, after the end of such discussions and analysis, Isis and Bayer do not mutually agree that Bayer shall Develop and Commercialize such Additional Indication, Isis may formally request Bayer in writing to Develop and Commercialize such an Additional Indication for ISIS-FXIRx. If Bayer does not confirm to Isis in writing that Bayer will initiate the Clinical Study required for the Development of such Additional Indication for ISIS-FXIRx within [***] Business Days following Bayer’s receipt of Isis’ request under this Section 1.4, then Isis shall have the right to conduct the Development of such Additional Indication for ISIS-FXIRx, unless Bayer reasonably believes in good faith and delivers a written objection to Isis detailing that [***], provided however, that Bayer has provided Isis with reasonable evidence documenting such issue or concern. If the prerequisites under this Section 1.4 are fulfilled and in the event the Clinical Study regarding such Additional Indication for ISIS-FXIRx [***], then Bayer shall exert Commercially Reasonable Efforts to Commercialize ISIS-FXIRx in such Additional Indication in the same countries Bayer is Commercializing ISIS-FXIRx, and shall [***]. Nothing in this Section 1.4 limits or otherwise relieves Bayer of its obligations under Section 1.1 or Section 1.6, provided however, that Isis [***].
Sample 1
Development of Additional Indications. Orion may continue to Develop Dexmedetomidine in Licensed Dosage Forms (a) for uses and indications other than the Field, and (b) for use in Licensed Dosage Form combination products in the Field CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***] HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. (“Additional Products”), at Orion’s sole expense and anywhere in the world. Notwithstanding the above, Orion shall not undertake Development activities in the United States, Australia or South Africa (provided such countries remain part of the Recro Territory) with respect to products for use in Licensed Dosage Form in the Field until four (4) years have lapsed since the grant of Regulatory Approval in the United States for the first Recro Product. Licensee shall have a right of first refusal to Commercialize each Additional Product in the Recro Territory in accordance with and subject to the terms of this Section 8.4. Licensee shall have ninety (90) days to consider any proposal of commercial terms by Orion. Licensee shall notify Orion in writing if it is interested in pursuing such proposal for any or all of the Additional Products described in such proposal. In such event, the Parties shall negotiate in good faith with a view to reaching a mutually acceptable agreement (if any) for such Additional Products, which negotiations shall include without limitation, meetings by phone at least twice monthly and in person at least monthly and meeting of senior management in person at least twice during the negotiation period. If the Parties, despite conducting good faith negotiations, do not finalize and execute a mutually acceptable binding agreement for such Additional Products within one hundred eighty (180) days after the date of Licensee’s notification of interest, Orion shall be free to enter into an agreement with a Third Party with respect to such Additional Products provided such agreement does not conflict with the rights granted to Licensee under this Agreement. For the avoidance of doubt it is expressly stated that nothing herein shall be deemed as to grant Licensee any negotiation or other rights in respect of any Dexmedetomidine Product in formulation(s) other than Licensed Dosage Forms, or to any Dexmedetomidine Product in a Licensed Dosage Form outside Recro Territory.
Sample 1

Related to Development of Additional Indications

  • 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 Contract Area, including its abandonment.

  • 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).

  • Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

  • 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.

  • Development Schedule The Project shall substantially comply with the specific timetables and triggers for action set forth in Article 5 of this Agreement. The parties acknowledge that, as provided in G.S. 160A-400.25(b), the failure to meet a commencement or completion date shall not, in and of itself, constitute a material breach of this Agreement pursuant to G.S. 160A-400.27 but must be judged based upon the totality of the circumstances.

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK Firms and/or individuals that assisted in the development or drafting of the specifications, requirements, statements of work, or solicitation documents contained herein are excluded from competing for this solicitation. This shall not be applicable to firms and/or individuals providing responses to a publicly posted Request for Information (RFI) associated with a solicitation.

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

  • 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 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.

  • 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.

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