Development Supply for the Development Program Sample Clauses

Development Supply for the Development Program. Company shall have the right to Manufacture Collaboration Compounds and/or finished Products in the Company Territory or the Reserved Territory as necessary for the conduct of the Development Program in the Company Territory other than Initial Phase I Clinical Trials. In an effort to establish efficient Manufacturing for Collaboration Compounds and/or finished Products, the Parties agree to use Commercially Reasonable Efforts to coordinate the Manufacturing activities in their respective territories, provided that each Party shall retain the right to Manufacture Collaboration Compounds and/or finished Products in quantities necessary for the Development Program in their respective territories. In the event that one Party agrees to supply the other Party with its requirements of Collaboration Compounds and/or finished Products in quantities necessary for the Development Program in their respective territories, then the transfer price for such Collaboration Compounds and/or Products for the conduct of the Development Program will be (i) [...***...] if the Collaboration Compounds and/or Products are Manufactured by a Party or its *Confidential Information, indicated by [...***...], has been omitted from this filing and filed separately with the Securities Exchange Commission. Affiliates in its or their own facility, or (ii) [...***...] if the Collaboration Compounds and/or Products are Manufactured by a contract manufacturer. Notwithstanding the foregoing, Licensor has the right to Manufacture Collaboration Compounds and/or finished Products as necessary for the Development Program or for the Commercialization of Products in the Reserved Territory and for the Initial Phase I Clinical Trials. In the event that, before expiry of the Option Date, Company has not exercised the option to continue the Agreement under Section 4.1(b) above, and Licensor in good faith concludes that Phase II Clinical Trial supplies of Collaboration Compound and/or finished Product and/or supplies of Collaboration Compound and/or finished Product for use in a 3-month tox study to enable a Phase III Clinical Trial need to be Manufactured to be able to meet the timelines set forth in the Development Plan, then Licensor shall notify Company and bring such need to Manufacture to the JAC for discussion and review, and the Parties shall negotiate in good faith whether or not, within which timeframe and under which terms and conditions such Manufacture is required to be assured (the “Phase II...
Sample 1See All (4)
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Development Supply for the Development Program. Company shall have the right to Manufacture XX-000, XX-000 and AR-301 and/or finished Products in or outside the Territory necessary for the conduct of the Development Program in the Territory. In an effort to establish efficient Manufacturing for XX-000, XX-000 xxx XX-000 and/or finished Products, the Parties agree to use Commercially Reasonable Efforts to coordinate the Manufacturing activities through the JAC in their respective territories, provided that each Party shall retain the right to Manufacture XX-000, XX-000 and AR-301 and/or finished Products in quantities necessary for the Development Program in their respective territories. In the event that one Party agrees to supply the other Party with its requirements of XX-000, XX-000 xxx XX-000 and/or finished Products in quantities necessary for the Development Program in their respective territories, then the transfer price for such XX-000, XX-000 xxx XX-000 and/or Products for the conduct of the Development Program shall be negotiated in good faith by the Parties on an arm’s-length basis.
Sample 1
Development Supply for the Development Program. Company shall have the right to Manufacture AR-101 and AR-301 and/or finished Products in or outside the Territory necessary for the conduct of the Development Program in the Territory. In an effort to establish efficient Manufacturing for AR-101 and AR-301 and/or finished Products, the Parties agree to use Commercially Reasonable Efforts to coordinate the Manufacturing activities through the JAC in their respective territories, provided that each Party shall retain the right to Manufacture AR-101 and AR-301 and/or finished Products in quantities necessary for the Development Program in their respective territories. In the event that one Party agrees to supply the other Party with its requirements of AR-101 and AR-301 and/or finished Products in quantities necessary for the Development Program in their respective territories, then the transfer price for such AR-101 and AR-301 and/or Products for the conduct of the Development Program shall be negotiated in good faith by the Parties on an arm’s-length basis.
Sample 1

Related to Development Supply for the Development Program

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

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. 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 COMPANY IF PUBLICLY DISCLOSED.

  • Development of Products (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.

  • 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 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 As defined in Section 3.2(a).

  • Development Schedule The schedule for design and development of the "BASE BUILDING WORK" (as defined below) and the "TENANT IMPROVEMENTS" (as defined below), including, without limitation, the time periods for preparation, delivery, review, and approval of construction documents and performance pursuant to such documents, shall be in accordance with the Development Schedule attached hereto as Schedule A, subject to adjustment as mutually agreed by the parties in writing or as provided in this Work Letter (the "DEVELOPMENT SCHEDULE").

  • Product Supply 5.2.1 HEMISPHERX undertakes and agrees to supply to IMPATIENTS on an exclusive basis, IMPATIENTS’ requirements of Product ordered in accordance with the terms of this Agreement, for distribution and sale in the Territory, limited to EAP use of Product in accordance with Early Access Approvals.

  • 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.

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