Territory Development Activities Sample Clauses

Territory Development Activities. (a) The Parties shall share equally all the Development Costs (whether incurred by Auxilium or Pfizer or their respective Affiliates) set forth in the applicable Development Budget with respect to any Territory Exclusive Development Activities (subject to Section 3.6.2); provided, however, that Pfizer may, on an indication-by-indication basis, recoup its fifty percent (50%) share of such Development Costs, to the extent relating to Development Activities prior to Product Approval, by means of an off-set against the milestone payment due upon First Commercial Sale of the Product for such indication.
Sample 1Sample 2
AutoNDA by SimpleDocs
Territory Development Activities. Subject to Section 4.4.3, Ono shall be solely responsible for [*] of all Development Costs incurred with respect to any Territory Development Activities, performed by or on behalf of Ono, including any Territory Clinical Arm (Multinational Studies).
Sample 1
Territory Development Activities. Actelion shall be solely responsible for one hundred percent (100%) of all Development Costs incurred by Actelion or Auxilium with respect to any Territory Development Activities (including, for clarity, any given General Development Activities which are deemed Territory Development Activities in accordance with Section 1.72). Auxilium shall invoice Actelion for Development Costs it incurs in connection with performing any Territory Development Activities, which invoices Actelion shall pay within thirty (30) days of receipt thereof.
Sample 1
Territory Development Activities. Asahi shall be solely responsible for one hundred percent (100%) of all Development Costs incurred by Asahi or Auxilium (to the extent as described in the next sentence) with respect to any Territory Development Activities (including, for clarity, any given Development Activities which are deemed Territory Development Activities in accordance with Section 1.83). For clarity, Asahi shall be responsible EXECUTION VERSION for Auxilium’s Development Costs incurred in performing Territory Development Activities to the extent that implementation of such Territory Development Activities by Auxilium is requested by Asahi or required by the terms and conditions of this Agreement (provided that, for clarity, Asahi shall not be responsible for any costs associated with materials or data which are already in the possession of Auxilium), and Auxilium shall invoice Asahi for Development Costs it incurs in connection with performing such Territory Development Activities, which invoices Asahi shall pay within thirty (30) days of receipt thereof.
Sample 1
Territory Development Activities. Sobi shall be solely responsible for one hundred percent (100%) of all Development Costs incurred by Sobi or Auxilium with respect to any Territory Development Activities (including, for clarity, any given General Development Activities which are deemed Territory Development Activities in accordance with Section 1.74). Auxilium shall invoice Sobi for Development Costs it incurs in connection with performing any Territory Development Activities, which invoices Sobi shall pay within thirty (30) days of receipt thereof.
Sample 1
Territory Development Activities. Licensee shall be solely responsible for one hundred percent (100%) of all Development Costs incurred by: (i) Licensee; or (ii) to the extent approved by the JDC or included in a Development Plan and Development Budget, Amarin (except to the extent as described in the next sentence), with respect to any Territory Development Activities (including, for clarity, any given Development Activities which are deemed Territory Development Activities in accordance with Section 1.83). To the extent reasonably requested by Licensee, Amarin shall provide assistance [***] in connection with the preparation and filing of the CTA application for the VHTG indication. In addition, in each Calendar Year, to the extent reasonably requested by Licensee, Amarin shall provide [***] for the performance or implementation of Territory Development Activities necessary for Regulatory Approval of the Product in the Territory. However, any Out-of-Pocket Costs incurred by Amarin in performing or implementing such assistance, or the internal costs for any assistance by Amarin in excess of [***], shall be borne by Licensee, and Amarin shall invoice Licensee for such Development Costs it incurs in connection with performing such Territory Development Activities, which invoices Licensee shall pay within [***] of receipt thereof. Notwithstanding the foregoing, Product and placebo required for the purpose of performing one or more clinical trials (i.e., clinical trial material) for the VHTG indication in the Territory will be provided by Amarin [***] to Licensee [***] in the aggregate (and Product or placebo required in excess of such number of subjects or for other Territory Development Activities shall be supplied to Licensee at Licensee’s sole cost and expense in accordance with Article 7). For clarity, Licensee shall be responsible for all freight, shipping, handling, imported tax and duties, clinical packaging and labeling, distribution and returns associated with any such Product.
Sample 1
Territory Development Activities. Unless otherwise agreed by the Parties or by any applicable Committee, Licensee shall be [***] of all Development Costs incurred by: (i) Licensee; or (ii) to the extent approved by the JMC or JCC or included in a Development Plan and Development Budget, VBL (except to the extent as described in the next sentence), with respect to any Territory Development Activities (including, for clarity, any given Development Activities which are deemed Territory Development Activities in accordance with Section 1). To the extent reasonably requested by Licensee, VBL shall cooperate and assist Licensee in the performance or implementation of Territory Development Activities necessary for Regulatory Approval of the Product in the Territory. However, Licensee shall bear any reasonable, documented and pre-approved (i) Out-of-Pocket Costs incurred by VBL in performing or implementing such assistance and (ii) internal labor costs for any assistance by VBL requiring VBL personnel to travel to Japan in excess of [***] (with the hourly rate per full-time equivalent being [***]), and VBL shall invoice Licensee for such costs, which invoices Licensee shall pay within thirty (30) days of receipt thereof. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,AS AMENDED.
Sample 1
AutoNDA by SimpleDocs
Territory Development Activities 
Sample 1

Related to Territory Development Activities

  • 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.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • 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 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:

  • 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.

  • 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 Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

  • Commercialization Diligence Upon receipt of the Marketing Authorization for a Licensed Product in the Field in a given Region in the Territory, Lian (directly, or through its Affiliates, Sublicensees or contractors) will use Commercially Reasonable Efforts to Commercialize such Licensed Product in the Field in such Region in the Territory. Lian will have sole decision-making authority and discretion with respect to Commercializing the Licensed Product in the Field in the Territory. [***].

  • Development Plan As defined in Section 3.2(a).

Time is Money Join Law Insider Premium to draft better contracts faster.