Manufacturing Transition Costs Sample Clauses

Manufacturing Transition Costs. All Manufacturing Costs associated with Manufacturing Shared Products and Companion Diagnostics (including Manufacturing Transition Costs) for U.S. Administration, excluding Manufacture of Shared Products and Companion Diagnostics for sale for U.S. Administration that are included as “Cost of Goods Sold” in the Profit & Loss Share, will be included in the calculation of Worldwide Development Costs, and shared by the Parties in accordance with the Development Cost Share. For clarity, any Manufacturing Costs associated with Manufacturing Shared Products and Companion Diagnostics (and associated CMC activities) that are not included in the Profit & Loss Share (as provided in the immediately preceding sentence), will be included in the calculation of Worldwide Development Costs (unless such costs are solely for ROW Administration). Article V
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Manufacturing Transition Costs. All Manufacturing Costs associated with Manufacturing Shared Products (including Manufacturing Transition Costs) shall be shared by the Parties in accordance with the Profit & Loss Share.
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Manufacturing Transition Costs. Any costs associated with Manufacturing (including Manufacturing Transition Costs), excluding Manufacture of Co-Co Products and Co-Co Diagnostic Products for sale for which such costs are included as “cost of goods sold” in the Profit & Loss Share, will be included in the calculation of Worldwide Development Costs, and shared by the Parties in accordance with the Development Cost Share. For clarity, any costs associated with Manufacturing (and CMC Activities) that are not Manufacturing Transition Costs, including any costs associated with the transition of Manufacturing activities from one Manufacturing site to another Manufacturing site, will be included in the calculation of Worldwide Development Costs.
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Manufacturing Transition Costs. Any costs associated with Manufacturing (including Manufacturing Transition Costs), excluding Manufacture of Co-Co Products and Co-Co Diagnostic Products for sale for which such costs are included as “Cost of Goods Sold” in the Profit & Loss Share, will be included in the calculation of Worldwide Development Costs, and shared by the Parties in accordance with the Development Cost Share. For clarity, any costs associated with Manufacturing (and CMC Activities) that are not Manufacturing Transition Costs, including any costs associated with the transition of CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Manufacturing activities from one Manufacturing site to another Manufacturing site, will be included in the calculation of Worldwide Development Costs.
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Manufacturing Transition Costs. Until any Co-Development Opt-Out Date all Manufacturing Costs associated with Manufacturing the Candidates and the Products (including Manufacturing Transition Costs) for Clinical Trials prior to the first Regulatory Approval in the Territory shall be shared by the Parties in accordance with their respective Co-Development Percentages. Article V
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Manufacturing Transition Costs. With respect to Licensed Products, [***] shall be responsible for all Manufacturing Transition Costs. For clarity, any costs associated with Manufacturing (and CMC Activities) that are not Manufacturing Transition Costs, including [***], will be solely borne by Celgene.
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Manufacturing Transition Costs. With respect to Co-Co Products, [***] shall be responsible for all Manufacturing Transition Costs. For clarity, any costs associated with Manufacturing (and CMC Activities) that are not Manufacturing Transition Costs, including [***], will be included in the calculation of Worldwide Development Costs, and shared by the Parties in accordance with Schedule 2.2.3(c)(ii), or, if incurred following Regulatory Approval of the Co-Co Product in the U.S., included in Operating Profits or Losses.
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Related to Manufacturing Transition Costs

  • Manufacturing Costs In the event of termination by Merck pursuant to Section 6.2, 6.3 or 6.6 above, Merck shall be entitled to [*****] (as defined herein) incurred by Merck for its Compound Delivered for the Study. [*****]

  • 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.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

  • Development Expenses Bionics will reimburse the Company for all reasonable expenses directly associated with the development of the Lead for Bionics (including, without limitation, costs associated with animal studies and human trials), when the Company submits a request to Bionics for approval prior to incurring such expenses and such expenses are incurred with Bionics’ written approval, provided receipts for such expenses are submitted to Bionics within 30 days after such expenses are incurred. Upon receiving a request for expense authorization from the Company, Bionics will indicate to the Company whether the requested expense is authorized within 15 days for expenses up to $1,000 and within 30 days for expenses over $1,000. Bionics will reimburse the Company within 30 days of receiving reasonably detailed invoices describing the Company’s authorized expenses under this Agreement. The Company will provide those invoices to Bionics within 15 days after the end of each month in which the Company incurs any authorized expense.

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.

  • 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.

  • Development Costs With respect to activities prior to the Amendment Effective Date, each Party was to pay [*] of the total Direct Development Costs of a Product incurred in accordance with the Development Budget (as defined in the Original Agreement). Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement to the contrary, with respect to activities on and after the Amendment Effective Date, subject to Sections 3.1.2, Alimera will be solely responsible for, and shall pay one hundred percent (100%) of, all development costs of a Product, including Direct Development Costs. Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement to the contrary, (i) all payments owing by CDS hereunder with respect to development activities prior to the Amendment Effective Date are hereby deemed fully paid by CDS (or waived, to the extent such waiver may be required), including any Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined in the Original Agreement), further including any penalties and interest which might have accrued with respect thereto, and further including all CDS payments deferred pursuant to that February 11, 2008 letter agreement sent by CDS and executed by CDS and Alimera regarding deferral of payments under the Original Agreement as of such date; (ii) all payments owing by Alimera hereunder with respect to development activities prior to the Amendment Effective Date are hereby deemed fully paid by Alimera (or waived, to the extent such waiver may be required), including any Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined in the Original Agreement), and further including any penalties and interest which might have accrued with respect thereto; and (iii) subject to Sections 3.1.1 and 3.1.2, from and after the Amendment Effective Date, CDS will have no liability whatsoever hereunder for any past, present or future development costs, including Direct Development Costs (which includes those incurred before, on and after the Amendment Effective Date), and instead Alimera shall have sole liability therefor.

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

  • 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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