U.S. Commercialization Budget Sample Clauses

U.S. Commercialization Budget. At such times as the JGC will deem appropriate, and concurrently with the preparation of the initial Worldwide Commercialization Plan, Celgene will prepare an initial U.S. Commercialization Budget, and the JGC will review and approve such initial U.S. Commercialization Budget. [***]
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U.S. Commercialization Budget. At such times as the JCC will deem appropriate, and concurrently with the preparation of the initial U.S. Commercialization Plan, Celgene (after good faith consultation with Jounce) will prepare an initial U.S. Commercialization Budget, and the JCC will review and approve such initial U.S. Commercialization Budget. Thereafter, Celgene (after good faith consultation with Jounce) will update the U.S. Commercialization Budget at least once in each Calendar Year, (but in any event no later than November 30 of each Calendar Year during the Co-Co Term) and the JCC will review and approve any such update or any other amendment to the U.S. Commercialization Budget. In addition, either Party may request at any time that the JCC consider and approve other updates to the U.S. Commercialization Budget.
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U.S. Commercialization Budget. At such times as the JCC will deem appropriate, and concurrently with the preparation of the initial U.S. Commercialization Plan, Jounce (after good faith consultation with Celgene) will prepare an initial U.S. Commercialization Budget, and the JCC will review and approve such initial U.S. Commercialization Budget. Thereafter, Jounce (after good faith consultation with Celgene) will update the U.S. Commercialization Budget at least once in each Calendar Year, (but in any event no later than November 30 of each Calendar Year during the Co-Co Term) and the JCC will 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. review and approve any such update or any other amendment to the U.S. Commercialization Budget. In addition, either Party may request at any time that the JCC consider and approve other updates to the U.S. Commercialization Budget.
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U.S. Commercialization Budget. The U.S. Commercialization Budget included in the U.S. Commercialization Plan shall be a rolling [***] [***] budget setting forth the budgeted amounts for costs with respect to activities allocated to the Parties under the U.S. Commercialization Plan during the then-current Calendar Year and the successive [***] Calendar Years thereafter, and shall include for both Parties a budget for FTE Costs and Out-of-Pocket Costs, broken down by Calendar Quarter for the then-current Calendar Year. The U.S. Commercialization Budget shall also include [***] as determined by the JCC in conjunction with the Finance Working Group. Concurrently with the annual preparation of the U.S. Commercialization Plan in accordance with Section 5.3.5(b), the JCC shall also prepare, and the JSC shall review to approve, an updated U.S. Commercialization Budget covering the next Calendar Year and the succeeding [***] [***].
Sample 1
U.S. Commercialization Budget. The Commercialization budget for the Product in the United States shall be (a) set forth in and comprise part of the U.S. Commercialization Plan and (b) divided as between the Marketing Plan and the Medical Affairs Plan. Unless otherwise agreed by the Parties without resort to the dispute resolution procedures of Section 16.2 [***]
Sample 1
U.S. Commercialization Budget. The US Commercialization Budget shall set forth the budgeted amounts for costs with respect to activities allocated to the Parties under such US Commercialization Plan [**] thereafter, and shall include for both Parties a budget for applicable Commercialization FTE Costs and Out-of-Pocket Costs for such period, broken down by Calendar Quarter for the then-current Calendar Year. The US Commercialization Budget shall also include a breakout of costs by functional area or category as determined by the JCC with input and support from the Finance Working Group. Concurrently with the annual update of the US Commercialization Plan in accordance with Section 5.3.1, the JCC will prepare, and the JSC will review and approve an updated US Commercialization Budget for the US Commercialization Plan. The US Commercialization Budget shall be binding unless and until amended in accordance with Section 5.3.1.
Sample 1
U.S. Commercialization Budget. The U.S. Commercialization Budget associated with a U.S. Commercialization Plan shall set forth the budgeted amounts for costs with respect to activities allocated to the Parties under such U.S. Commercialization Plan, and shall include for both Parties a budget for applicable Commercial FTE Costs and Out-of-Pocket Costs, broken down by Calendar Quarter for the then-current Calendar Year. The Commercialization Budget shall also include a breakout of costs by functional area or category as determined by the JCC.
Sample 1
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U.S. Commercialization Budget. The U.S. Commercialization Plan shall include a [***] rolling budget for Allowable Expenses to be incurred by the Parties in conducting Commercialization activities for the Profit Share Product in the U.S. pursuant to the U.S. Commercialization Plan during [***] the “U.S. Commercialization Budget”). The U.S. Commercialization Budget shall include budgeted amounts for Commercial FTE Costs and Out-of-Pocket Expenses, broken down by Calendar Quarter for [***], for Commercialization activities in the U.S. and a breakout of costs by functional area or category, as determined by the USJCC in conjunction with the JFC. The [***] of the U.S. Commercialization Budget [***] to the extent provided in the Financial Exhibit, and the [***] shall serve as [***] (subject to any other applicable restrictions in this Exhibit). Each U.S. Commercialization Budget shall also include an annual amount for strategic commercial efforts that will be undertaken by Xxxxxxx and its Affiliates at the global team level in accordance with the global commercialization strategy described in Section 5.1.2(e), of which [***] percent ([***]%) shall be allocable to the U.S. (the “Allocable Global Costs”).
Sample 1
U.S. Commercialization Budget. At such times as the JCC will deem appropriate, and concurrently with the preparation of the initial U.S. Commercialization Plan, [***] will prepare an initial U.S. Commercialization Budget, and the JCC will review and approve such initial U.S. Commercialization Budget. Thereafter, [***] will update the U.S. Commercialization Budget at least once in each Calendar Year, (but in any event no later than [*** ]of each Calendar Year during the Co-Co Term) and the JCC will review and approve any such update or any other amendment to the U.S. Commercialization Budget. In addition, either Party may request at any time that the JCC consider and approve other updates to the U.S. Commercialization Budget. Notwithstanding the foregoing, the terms of Section 6.4 shall apply.
Sample 1

Related to U.S. Commercialization Budget

  • 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 Concession Area, including its abandonment.

  • 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.

  • Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

  • 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 Plans Shipper has provided Gatherer with a report attached hereto as Exhibit D (the “Current Development Plan”) describing in detail, as of January 1, 2017, the planned development, drilling, and production activities to take place with respect to Dedicated Production for the applicable Development Period. The information contained in the TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THE REDACTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION, AND THE TERMS HAVE BEEN MARKED AT THE APPROPRIATE PLACE WITH TWO ASTERISKS (**). Current Development Plan is broken out on a Subsystem-by-Subsystem basis and, with respect to the first three Years covered by the Current Development Plan, on a Quarter-by-Quarter basis, and with respect to the remaining Years covered by the Current Development Plan, on a Year-by-Year basis. The Current Development Plan attached hereto has been approved by the Parties. (a) From time to time during each Year of the Term, the Parties shall meet to discuss the planned development, drilling, and production activities that Shipper expects to take place with respect to Dedicated Production for the then-applicable Development Period. Shipper and Gatherer shall each make their respective representatives available to participate in such meetings and discussions. No later than August 1 of each such Year, Shipper shall provide (or cause to be provided) to Gatherer a proposed update of the then-currently agreed Development Plan, prepared on the same basis as the Current Development Plan and describing in detail the planned development, drilling, and production activities to take place with respect to Dedicated Production for the then-applicable Development Period (any such update, an “Updated Development Plan” and, together with the Current Development Plan, each, a “Development Plan”). Notwithstanding anything herein to the contrary, in no event shall Gatherer be required to agree to any Updated Development Plan and corresponding updated Gathering System Plan that contains a Committed Build-Out that (i) has a corresponding Target Completion Date that occurs after the end of the Initial Term, and (ii) Gatherer, in its sole discretion, does not wish to approve. (b) Each proposed Development Plan shall include information as to the following, in each case, broken out on a Subsystem-by-Subsystem basis and, with respect to the first three Years covered by such Development Plan, on a Quarter-by-Quarter basis, and, with respect to the remaining Years covered by such Development Plan, on a Year-by-Year basis: (i) all Xxxxx that, as of the date such Development Plan was delivered, are currently in existence and (A) the production therefrom is being delivered into the Gathering System, or (B) are awaiting connection to the Gathering System; (ii) the Xxxxx that are expected to be drilled during the time period covered by such Development Plan (each such Well reflected in such Development Plan, a “Planned Well”), and the estimated timing of the drilling of such Planned Xxxxx; (iii) forward-looking production estimates for the applicable time period covered by such Development Plan for all Shipper Gas (A) that Shipper reasonably and in good faith believes will become owned or Controlled by Shipper during the time period covered by such Development Plan, and/or (B) that will be produced from (I) in the aggregate, all Xxxxx then-existing and (II) in the aggregate, any Planned Xxxxx included in such Development Plan (such collective estimates described in subsections (A) and (B), both with respect to a particular Quarter and an entire Year, the “Dedicated Production Estimates”); TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THE REDACTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION, AND THE TERMS HAVE BEEN MARKED AT THE APPROPRIATE PLACE WITH TWO ASTERISKS (**). (iv) forward-looking estimates for the applicable time period covered by such Development Plan of the aggregate volumes of those Shipper Injected Liquids that Shipper intends to Tender to the Injection Points hereunder to receive the System Services (such estimates, both with respect to a particular Quarter and an entire Year, the “System Liquids Estimates” and, together with the Dedicated Production Estimates, the “System Production Estimates”); (v) (A) each new receipt point (including the location thereof) proposed by Shipper with respect to the System Production Estimate reflected in such Development Plan (each such receipt point, including those located at the site of a Planned Well, a “Planned Receipt Point”), (B) each Receipt Point at which Shipper expects to Tender Shipper Gas and/or Shipper Injected Liquids reflected in such Development Plan into the Gathering System, and (C) the estimated portion of the System Production Estimate contained in such Development Plan that Shipper expects to Tender at each such Receipt Point and Planned Receipt Point; (vi) the earliest date on which each Planned Well included in the Development Plan is estimated to be completed and producing, which date shall not be earlier than three Months after the January 1st that is immediately subsequent to the date that the Development Plan that initially reflected such Planned Well was delivered to Gatherer hereunder; (vii) the anticipated characteristics of the production from the Xxxxx and Planned Xxxxx reflected in such Development Plan (including liquids content and gas and liquids composition) and the projected production volumes and production pressures applicable thereto; provided that Shipper may utilize the existing and historical production information from similarly situated Xxxxx; (viii) (A) each new delivery point (including the location thereof) proposed by Shipper with respect to the System Production Estimate reflected in such Development Plan (each such delivery point, a “Planned Delivery Point”), (B) each Delivery Point at which Shipper expects Shipper Gas produced from the Xxxxx and Planned Xxxxx reflected in such Development Plan to be redelivered to Shipper, (C) each Delivery Point at which Shipper expects any Drip Liquids allocated to Shipper in accordance with this Agreement and/or Shipper Injected Liquids to be redelivered to Shipper, and (D) the estimated portion of the System Production Estimate contained in such Development Plan that Shipper expects to be redelivered to Shipper at each such Delivery Point and Planned Delivery Point; (ix) any (A) proposed revision to the then-existing Dedicated Area and/or any then-existing Dedicated Contract and/or (B) any new contract that Shipper proposes to be a Dedicated Contract; and (x) other information reasonably requested by Gatherer that is relevant to the design, construction, and operation of the Gathering System, including (A) any Subsystem Extension proposed by Shipper, (B) the relevant Receipt Point, Planned Receipt Point, Delivery Point and Planned Delivery Point facilities applicable to such TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THE REDACTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION, AND THE TERMS HAVE BEEN MARKED AT THE APPROPRIATE PLACE WITH TWO ASTERISKS (**). Development Plan, and (C) any treating, processing, or liquids handling facilities proposed by Shipper that may be required for any Shipper Gas and/or Shipper Injected Liquids to meet applicable Downstream Facility specifications at the Delivery Points.

  • 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.

  • Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

  • 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.

  • Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular: (a) review and recommend the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory; (b) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Territory and the Exelixis Territory; (c) on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization; (e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any; (f) review and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product; (g) discuss Product list price and status of reimbursement in the Collaborator Territory; and (h) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JEC.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

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