Restrictions on Targacept’s Development and Commercialization of Option Compounds Sample Clauses

Restrictions on Targacept’s Development and Commercialization of Option Compounds. Notwithstanding anything to the contrary in this Section 5.10.2, AstraZeneca shall not be required to consider or take any further action with respect to, and Targacept shall have no right to develop, commercialize or otherwise Exploit (other than as expressly permitted under Section 8.6), with respect to any Option Compound in the event that: (1) the IND-Ready Notice for such Option Compound specifies a Primary Indication (other than ADHD or any type of Dementia) or Schizophrenia and there is an Option Compound (i) for which an IND-Ready Notice has been served previously that specifies the same indication and in respect of which AstraZeneca has served the Option Maintenance Notice but it has not yet been determined whether such Option Compound shall be an Option Compound Candidate Drug, a Terminated Compound or an Unexercised Option Compound, or (ii) for which AstraZeneca exercised an IND-Ready Option or POC Option and for which the resulting Option Compound Candidate Drug is being Developed or the Option Compound Product is being (or has been) Commercialized, in each case, by AstraZeneca or any of its Affiliates or Sublicensees for a Principal Indication that is the same as such specified Option Indication, unless the second Option Compound [********] is [********] to that first Option Compound; provided that Targacept shall not provide the IND-Ready Notice for [********] to [********] Option Compound for that same indication until the earlier of (A) [********] of (1) AstraZeneca’s exercise of the IND-Ready Option for such first Option Compound pursuant to Section 5.10.2(b)(1), (2) AstraZeneca’s payment of the Option Maintenance Fee for such first Option Compound pursuant to Section 5.10.2(b)(3) or (3) in the event the Parties are unable to agree on an Option Compound Development Plan, Targacept’s delivery to AstraZeneca of a Targacept Option Compound Development Plan, whichever is applicable, and (B) completion of [********] for such first Option Compound; and provided further that in the event of a dispute as to whether an Option Compound is [********], such dispute shall be resolved by an Expert in accordance with Section 14.3 (accelerated arbitration); (2) the IND-Ready Notice for such Option Compound specifies a Primary Indication and there are at that time [********] Option Compounds in respect of which (i) IND-Ready Notices have been served previously, the Principal Indication for each of which is a Primary Indication and in respect of which Astra...

Related to Restrictions on Targacept’s Development and Commercialization of Option Compounds

  • 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).

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  • 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 Rights The Employee agrees and declares that all proprietary information including but not limited to trade secrets, know-how, patents and other rights in connection therewith developed by or with the contribution of Employee's efforts during his employment with the Company shall be the sole property of the Company. Upon the Company's request (whenever made), Employee shall execute and assign to the Company all the rights in the proprietary information.

  • 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.