Process Development Budget Sample Clauses

Process Development Budget. The CMC Development Collaboration will be subject to a rolling budget covering Process Development Costs associated with the anticipated Process Development Activities to be performed during the [***] (such [***] period, the “[***] Process Development Budget Period”), in each case broken down by Calendar Quarter and broken out on a line item basis to show Out-of-Pocket Costs and FTE Costs of FTEs directly engaged to perform each such Process Development Activity and further broken down by Party (the “Process Development Budget”). [***] following the Effective Date, the Process Development Budget will be developed by the JMC, and recommended and proposed to the JSC for review and approval, and upon approval by the JSC, each such Process Development Budget will be automatically incorporated into this Agreement by reference and form a part of this Agreement. The Process Development Budget will be reviewed by the JMC and approved by the JSC (i) at least [***] (and [***] for the first Calendar Year of the applicable [***] Process Development Budget Period) based on: (A) the Parties’ good faith estimation of the anticipated Process Development Activities to be conducted during the relevant [***] Process Development Budget Period; and (B) information prepared by the Parties in good faith for their own internal planning processes relating to anticipated Process Development Activities; or (ii) whenever the total Process Development Costs for any given Calendar Quarter are reasonably expected to be at least [***] percent ([***]%) higher than the Process Development Budget for such Calendar Quarter, whether as a result of any amendments to the CMC Development Plan or increases in costs for the Process Development Activities already planned for such Calendar Quarter (provided, however, that following the beginning of a Calendar Year, the JSC may not increase the Process Development Budget for such Calendar Year by more than [***] percent ([***]%) without the Parties’ prior written approval). Each such amended or updated Process Development Budget will automatically replace the respective Process Development Budget previously in effect, and will be automatically incorporated into this Agreement by reference and form a part of this Agreement. With respect to any Calendar Quarter, in no event will a Party be responsible for any Process Development Costs that exceed the respective portion of the then-current Process Development Budget recommended and proposed by the JMC a...
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Related to Process Development Budget

  • Development Budget Attached hereto as Exhibit "B" and incorporated herein by this reference is the Development Budget in an amount equal to $_____________. Owner acknowledges and represents that the attached Development Budget includes the total costs and expenses to acquire, develop, renovate and construct the Real Property and the Apartment Housing.

  • Initial Development Plan Not later than the Effective Date, Licensee shall have provided Merck with an initial Development plan for the Licensed Product in the Field in the Territory, which shall be incorporated as part of this Agreement as Attachment 3.02(a) (as may be amended in accordance with this Agreement, the “Development Plan”). **CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  • Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.

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

  • Business Development Provide advice and assistance in business growth and development of Party B. 业务发展。对乙方的业务发展提供建议和协助。

  • Business Plan and Budget To the extent requested by any Initial Lender, as soon as available, but in any event within thirty (30) days after the end of each fiscal year of the Borrower, an annual business plan and budget of the Borrower and its Subsidiaries on a Consolidated basis, including forecasts prepared by management of the Borrower, in form satisfactory to such Lender, of Consolidated balance sheets and statements of income or operations and cash flows of the Borrower and its Subsidiaries on a monthly basis for the immediately following fiscal year. As to any information contained in materials filed with the SEC or furnished pursuant to Section 6.2(f), the Borrower shall not be separately required to furnish such information under Section 6.1(a) or (b) above, but the foregoing shall not be in derogation of the obligation of the Borrower to furnish the information and materials described in Sections 6.1(a) and (b) above at the times specified therein.

  • 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.

  • Budget Borrower shall submit to Lender for Lender’s written approval (provided that such approval shall only be required in the event that Borrower or any Affiliate of Borrower has the right to approve any such budget pursuant to the terms of the Management Agreement) not to be unreasonably withheld, an annual budget (the “Annual Budget”) within ten (10) Business Days after receipt thereof from Manager, in form satisfactory to Lender setting forth in reasonable detail budgeted monthly operating income and monthly operating capital and other expenses for the Premises. In the event Lender shall have the right to approve such Annual Budget and Lender objects to the proposed Annual Budget submitted by Borrower, Lender shall advise Borrower of such objections within fifteen (15) days after receipt thereof (and deliver to Borrower a reasonably detailed description of such objections) and Borrower shall, within three (3) days after receipt of notice of any such objections, revise such Annual Budget and resubmit the same to Lender. Lender shall advise Borrower of any objections to such revised Annual Budget within ten (10) days after receipt thereof (and deliver to Borrower a reasonably detailed description of such objections) and Borrower shall revise the same in accordance with the process described herein until Lender approves an Annual Budget, provided, however, that if Lender shall not advise Borrower of its objections to any proposed Annual Budget within the applicable time period set forth in this Section, then such proposed Annual Budget shall be deemed approved by Lender. If Lender has the right to approve the Annual Budget pursuant to the terms of the Management Agreement, until such time that Lender approves a proposed Annual Budget, the most recently Approved Annual Budget shall, except as otherwise provided in the Management Agreement, apply; provided that, such Approved Annual Budget shall be adjusted to reflect actual increases in Basic Carrying Costs and utilities expenses. In the event that Owner must incur an Extraordinary Expense, then Borrower shall promptly deliver to Lender a reasonably detailed explanation of such proposed Extraordinary Expense which, if Borrower has the right to approve such expenditures pursuant to the terms of the Management Agreement, shall be subject to Lender’s approval, which approval may be granted or denied in Lender’s reasonable discretion.

  • 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.

  • Annual Business Plan and Budget As soon as practicable and in any event not later than thirty (30) days after the end of each Fiscal Year, a business plan and operating and capital budget of the Borrower and its Subsidiaries for the ensuing four (4) fiscal quarters, such plan to be prepared in accordance with GAAP and to include, on a quarterly basis, the following: a quarterly operating and capital budget, a projected income statement, statement of cash flows and balance sheet, calculations demonstrating projected compliance with the financial covenants set forth in Section 9.15 and a report containing management’s discussion and analysis of such budget with a reasonable disclosure of the key assumptions and drivers with respect to such budget, accompanied by a certificate from a Responsible Officer of the Borrower to the effect that such budget contains good faith estimates (utilizing assumptions believed to be reasonable at the time of delivery of such budget) of the financial condition and operations of the Borrower and its Subsidiaries for such period.

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