DEVELOPMENT STAGE PRODUCT Sample Clauses

DEVELOPMENT STAGE PRODUCT. Notwithstanding any other provision of this AGREEMENT, the DEVELOPMENT STAGE PRODUCT shall not be an HMR NEWLY DEVELOPED PRODUCT for purposes of this AGREEMENT, and is not subject to the MEDICIS RIGHT OF FIRST OFFER. The parties have agreed to certain matters, rights and obligations pertaining to the DEVELOPMENT STAGE PRODUCT as set forth on Schedule 5.1 hereto, the terms of which are incorporated herein by reference.
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DEVELOPMENT STAGE PRODUCT. Notwithstanding any other provision of this AGREEMENT or any provision of the other TRANSACTION DOCUMENTS, and except to the extent that rights or information are lawfully available to a third party (which is not HMR or their AFFILIATES, or their successors, assigns, licensees or sublicensees), for such purposes as are utilized by MEDICIS, its AFFILIATES, their successors and assigns and their licensees and sublicensees, under applicable U.S. Federal statutes or the regulations or rules promulgated thereunder (including those rights that any such third party would have under the U.S. Federal Food, Drug and Cosmetic Act, the U.S. Freedom of Information Act or any other U.S. Federal statute, but excluding (A) rights triggered or provided by any contractual or license rights granted to any such third party by HMR or their AFFILIATES or their successors and assigns or their licensees and sublicensees or (B) information which enters the public domain due to, by or pursuant to the action or inaction, directly or indirectly, of MEDICIS, its AFFILIATES, their successors and assigns and their licensees and sublicensees), MEDICIS, its AFFILIATES, their successors and assigns and their licensees and sublicensees shall not directly or indirectly access, review, disclose, reference or utilize the Drug Master Files, the NDAs or the INTELLECTUAL PROPERTY (including but not limited to New Drug Applications for the MEDICIS NEWLY DEVELOPED PRODUCTS, any IMPROVEMENTS, the HMR NEWLY DEVELOPED PRODUCTS, the DEVELOPMENT STAGE PRODUCT, or the additional Loprox PRODUCT discussed in Schedule 13 hereto, or any other regulatory approval based upon, arising out of or related to the Drug Master Files, the NDAs, such New Drug Applications or the INTELLECTUAL PROPERTY (other than the TRADEMARKS) or any information contained therein) (i) for the development, regulatory approval and/or commercialization of a COMPETING NAIL TOPICAL PRODUCT, or (ii) that relate to the ACTIVE INGREDIENTS; provided, however, that in no event or circumstance whatsoever shall the existence of such information in the public domain be deemed a release, modification or waiver of the restrictions

Related to DEVELOPMENT STAGE PRODUCT

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

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Development Work Do, or cause to be done, such development and other work as may be reasonably necessary to protect from diminution and production capacity of the Mortgaged Property and each producing well thereon.

  • 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).

  • 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.

  • 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.

  • Development Efforts Genentech will use commercially reasonable and diligent efforts to develop C2B8, including pursuing preclinical development and clinical development of C2B8 and obtaining Regulatory Approvals therefor in all countries in the Licensed Territory, taking into account the scientific and commercial potential of C2B8, including, without limitation, each of the potential indications in the Field for C2B8. Within ninety (90) days of the Original Effective Date, Genentech agrees to provide IDEC with a written development strategy for C2B8 in the Licensed Territory indicating (i) whether Genentech will develop C2B8 alone or with a partner in Europe, (ii) the identity of its European partner (if any), and (iii) a list of clinical trials which Genentech would conduct for C2B8 approval in Europe assuming adequate quantities of C2B8 are available.

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

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