Lead Development Party; Lead Regulatory Party Sample Clauses

Lead Development Party; Lead Regulatory Party. The Participating Phase IIb Party for particular Unilateral Phase IIb Development shall be the Lead Development Party and the Lead Regulatory Party for such Unilateral Phase IIb Development.
Sample 1Sample 2Sample 3See All (6)
AutoNDA by SimpleDocs
Lead Development Party; Lead Regulatory Party. With respect to a Unilateral Phase III Plan for a Unilateral Product in an Indication for a Royalty Region, the applicable Participating Phase III Party shall be the Lead Development Party and Lead Regulatory Party with respect to the Development activities under such Unilateral Phase III Plan (including with respect to the preparation and filing of all Drug Approval Applications for such Unilateral Product in such Indication in such Royalty Region).
Sample 1Sample 2Sample 3
Lead Development Party; Lead Regulatory Party. Reata shall have the option to be the Lead Development Party and Lead Regulatory Party for Joint Exploratory Development involving a Development Candidate that (i) is a FirstGen Targeted AIM or (ii) is a NextGen Targeted AIM for which Joint Exploratory Development commences during the Initial Studies Period. For Joint Exploratory Development involving a Development Candidate that is a NextGen Targeted AIM that commences after the Initial Studies Period, the JRDI shall appoint the Party that will be the Lead Development Party and Lead Regulatory Party. If the JRDI cannot agree on the Party that will be the Lead Development Party and Lead Regulatory Party, [***] shall have the option to be the Lead Development Party and Lead Regulatory Party for the first Development Candidate that is a NextGen Targeted AIM to be Developed after the Initial Studies Period, and the Parties thereafter shall alternate as to which Party shall have the option to be the Lead Development Party and Lead Regulatory Party for each Development Candidate that is a NextGen Targeted AIM to be Developed after the Initial Studies Period. For any Joint Exploratory Development, the LDP shall have the primary responsibility for developing a work plan including the details of or protocols for any of the Non-Clinical Studies or Clinical Studies listed in the then-current Joint Exploratory Development Plan; provided that such work plans (including protocols) shall be subject to approval by the JRDI. In the event the JRDI cannot agree on the work plan for a particular Non-Clinical Study or Clinical Study (or the protocol thereof) within a [***]-day period, then such matter shall be referred to the JEC for resolution. If the JEC cannot resolve such matter within a [***]-day period, then such matter shall be referred to the Parties’ Senior Officers for resolution. If such Senior Officers cannot resolve such matter within a [***])-day period [***]. In the event the JRDI cannot agree on any amendment of a particular work plan or protocol within a [***]-day period, then such matter shall be referred to the JEC for resolution. If the JEC cannot resolve such matter within a [***]-day period, then such matter shall be referred to the Parties’ Senior Officers for resolution. If such Senior Officers cannot resolve such matter within a [***]-day period, then, [***].
Sample 1
Lead Development Party; Lead Regulatory Party. With respect to a Joint Phase III Plan for a Joint Product in an Indication for a Profit Share Region, (A) the Party that was the Lead Development Party for Phase IIb Development for such Joint Product in such Indication shall remain the Lead Development Party for such Joint Product in such Indication in such Profit Share Region; and (B) the Party that was the Lead Regulatory Party for Phase IIb Development for such Joint Product in such Indication in such Region shall remain the Lead Regulatory Party with respect to the Development activities for such Joint Product in such Indication in such Profit Share Region up to and including the preparation, filing and approval of all Drug Approval Applications for such Joint Product in each Commercialization Territory, and thereafter the Lead Commercialization Party for such Joint Product in each Commercialization Territory (as determined in accordance with Section 5.6(e)(vi) or Section 7.3) shall be Lead Regulatory Party with respect to all other regulatory Development, Manufacturing and Commercialization activities with respect to such Joint Product in such Commercialization Territory thereafter.
Sample 1Sample 2
Lead Development Party; Lead Regulatory Party. If Pre-Phase IIb Development activities were conducted for a Product Candidate (either jointly or unilaterally), the Party that was the LDP and LRP for such Pre-Phase IIb Development activities shall be the LDP and LRP for Joint Phase IIb Development activities for such Product Candidate unless otherwise agreed by the Parties. If no Pre-Phase IIb Development activities were conducted for a Product Candidate, the Party that was the LDP and LRP for Exploratory Development Activities for such Product Candidate shall be the LDP and LRP for Joint Phase IIb Development activities for such Product Candidate unless otherwise agreed by the Parties. Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission.
Sample 1
Lead Development Party; Lead Regulatory Party. If Pre-Phase IIb Development activities were conducted for a Product Candidate (either jointly or unilaterally), the Party that was the LDP and LRP for such Pre-Phase IIb Development activities shall be the LDP and LRP for Joint Phase IIb Development activities for such Product Candidate unless otherwise agreed by the Parties. If no Pre-Phase IIb Development activities were conducted for a Product Candidate, the Party that was the LDP and LRP for Exploratory Development Activities for such Product Candidate shall be the LDP and LRP for Joint Phase IIb Development activities for such Product Candidate unless otherwise agreed by the Parties.
Sample 1

Related to Lead Development Party; Lead Regulatory Party

  • Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • 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 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 Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:

  • Joint Manufacturing Committee A joint manufacturing committee (the “Joint Manufacturing Committee” or “JMC”) will be established pursuant to the Supply Agreement. The roles and responsibilities of the JMC shall be as specified in the Supply Agreement.

  • Collaboration Management Promptly after the Effective Date, each Party will appoint a person who will oversee day-to-day contact between the Parties for all matters related to the management of the Collaboration Activities in between meetings of the JSC and will have such other responsibilities as the Parties may agree in writing after the Effective Date. One person will be designated by Merck (the “Merck Program Director”) and one person will be designated by Moderna (the “Moderna Program Director,”) together will be the “Program Directors”. Each Party may replace its Program Director at any time by notice in writing to the other Party. Any Program Director may designate a substitute to temporarily perform the functions of that Program Director by written notice to the other Party. The initial Program Directors will be: For Moderna: [***] For Merck: [***]

  • 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 NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!