Project III: CGMP Production Run Sample Clauses

Project III: CGMP Production Run. Molecular Medicine will perform one (1) 10L GMP Production run using the Sponsor’s MVB to yield clinical grade bulk drug product (BDP) and verify the technical transfer process. All GMP runs will be performed in accordance with the process confirmed and resulting from the technical transfer process and analysis of data from the Technical Transfer Run(s). All work performed for this production will occur in the MOLECULAR MEDICINE cGMP multi-product facility (Carlsbad, CA) with approved Batch Production Records (BPRs). Batch Production Records must be reviewed and approved by a Quality and Technical representative of Sponsor prior to use. Costs per cGMP Production Runs do not include fill/finish. Table 3: Costs for Technical Transfer Run(s) and cGMP Run(s) Scale Location Cost Duration Report Documentation Fees 10L Bioreactor, First Technical Transfer Run PD Lab $ 265,000 (a.) Final Report $ 10,000 10L Bioreactor, Subsequent Runs cGMP $ 345,000 (a.) Certificate of Compliance $ 10,000 (a.) As per Exhibit C timeline. MMB DMB 1/18/06 CARDIUM TD 1/19/06 EXHIBIT ASCOPE OF WORK
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Related to Project III: CGMP Production Run

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

  • Production Work Except as agreed to in writing by the Parties pursuant to the "Production Work" section of the Standard Online Commerce Terms & Conditions attached hereto as Exhibit F, MP will be responsible for all production work associated with the Affiliated MP Site, including all related costs and expenses.

  • Project Plan Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s “A multi-center, randomized, double-blind, double-dummy, vehicle-controlled sequential cohort study to determine the safety of PEP005 0.025% and 0.05% topical gel in patients with actinic keratoses” (hereinafter “the Project”) and associated costs. Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to the Project costs.

  • 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").

  • 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 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 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

  • Project Scope This section should contain SOW summary information including: o Project definition and expected duration o Project goals, objectives, o Priorities & expectations o Project approach & responsibilities o Overall coordination and assumptions

  • 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).

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