Anticipated First Commercial Sale definition

Anticipated First Commercial Sale means, with respect to a Licensed Product in the Field, the date agreed upon by the JSC in advance as the expected date of First Commercial Sale of such Licensed Product in the Field in a country in the Territory.
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Anticipated First Commercial Sale means, with respect to a VEGF Product, the date agreed upon by the Parties in advance as the expected date of First Commercial Sale of such VEGF Product in any Therapeutic Area in a country.
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Anticipated First Commercial Sale means, with respect to a Co-Funding Product, the date agreed upon in advance by the JSC as the expected date of First Commercial Sale of such Co-Funding Product in such country or Region (as applicable) of the world if specified or, otherwise, any country in the world. The JSC shall attempt to agree upon such date [***] in advance of its expected occurrence. In the event that Development timelines are accelerated such that the JSC is unable to agree on the expected date of First Commercial Sale [***] in advance of its expected occurrence, the JSC shall attempt to agree upon the Anticipated First Commercial Sale as soon as practicable after the [***].
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Examples of Anticipated First Commercial Sale in a sentence

  • The JMC shall use all reasonable efforts to make such determination no later than three (3) years prior to the Anticipated First Commercial Sale of each Licensed Product.

  • The JSC shall use good faith efforts to approve the Commercial Plan at least [***] prior to the Anticipated First Commercial Sale for a Product in such Major Market Country.

  • The initial Country Co-Commercialization Plan and Country Co-Commercialization Budget for each VEGF Product in each Co-Commercialization Country will be prepared by the applicable Joint Country Commercialization Sub-Committee at least [**********] before the Anticipated First Commercial Sale of such VEGF Product in such Co-Commercialization Country.

  • Each Country/Region Commercialization Plan with respect to each Licensed Product shall include (with sufficient detail, relative to time remaining to Anticipated First Commercial Sale, to enable the JCC to conduct a meaningful review of such Plan) information and formatting as will be agreed upon by the JCC, including the overall strategy for Commercializing such Licensed Product, ***********, market and sales forecasts, and estimated FTE and Shared Commercial Expenses.

  • Each Country/Region Commercialization Plan with respect to each Licensed Product shall include (with sufficient detail, relative to time remaining to Anticipated First Commercial Sale, to enable the JCC to conduct a meaningful review of such Plan) information and formatting as will be agreed upon by the JCC, including the overall strategy for Commercializing such Licensed Product, **************, market and sales forecasts, and estimated FTE and Shared Commercial Expenses.

  • The initial Country Commercialization Plan for each Major Market Country will be prepared by Company, with Regeneron’s participation and input, and approved by the JCC at least [**********] before the Anticipated First Commercial Sale in the applicable Major Market Country.

  • Once approved by the JCC, the Territory Commercialization Plan will be presented to the JSC for review and approval at least [***********] before the Anticipated First Commercial Sale in the Territory.

  • At least [*************] prior to the Anticipated First Commercial Sale, the Parties shall enter into separate commercial supply agreements with respect to the quality assurance/quality control, forecasting, ordering and delivery of Clinical Supply Requirements and Commercial Supply Requirements after the First Commercial Sale, which shall contain terms consistent with this Agreement.

  • The Parties shall establish a JDCC to (i) direct and facilitate a [***] and a [***] suitable to produce a global registration package and (ii) beginning no later than twenty-four (24) months prior to the Anticipated First Commercial Sale of a Product and assuming InterMune has not exercised its Opt-Out, consider and discuss strategic options related to Commercialization and facilitate the development of a Co-Commercialization Plan.

  • Each Country/Region Commercialization Plan with respect to each Licensed Product shall include (with sufficient detail, relative to time remaining to Anticipated First Commercial Sale, to enable the JCC to conduct a meaningful review of such Plan) information and formatting as will be agreed upon by the JCC, including the overall strategy for Commercializing such Licensed Product, ***************, market and sales forecasts, and estimated FTE and Shared Commercial Expenses.


More Definitions of Anticipated First Commercial Sale

Anticipated First Commercial Sale means, with respect to a Product in the Kiniksa Field in a particular country in the Territory, the expected date of First Commercial Sale of such Product in the Kiniksa Field in such country.
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Anticipated First Commercial Sale means, with respect to a Licensed Product in the Field, the date agreed upon by the JSC in advance as the expected date of First Commercial Sale of such Licensed Product in the Field in a country in the Territory. 1.6 "Approval" shall mean, with respect to each Licensed Product, any approval (including Marketing Approvals and Pricing Approvals), registration, license or authorization from any Regulatory Authority required for the Development, Manufacture or Commercialization of such Licensed Product in the Field in a regulatory jurisdiction anywhere in the world, and shall include, without limitation, an approval, registration, license or authorization granted in connection with any Registration Filing. 1.7 "Aventis LLC" shall mean sanofi-aventis US LLC (successor in interest under the Aventis Collaboration Agreement to Aventis Pharmaceuticals Inc.). 1.8 "Aventis Collaboration Agreement" shall mean the Collaboration Agreement, dated as of September 5, 2003, by and between Aventis LLC and Regeneron, as amended by the First Amendment, dated as of December 31, 2004, the Second Amendment, dated as of January 7, 2005, the Third Amendment, dated as of December 21, 2005, the Fourth Amendment, dated as of January 31, 2006, and Section 11.2 of the Sanofi Stock Purchase Agreement, as the same may be further amended from time to time. 1.9 "Aventis Stock Purchase Agreement" shall mean the Stock Purchase Agreement dated as of September 5, 2003 by and between Aventis Pharmaceuticals Inc. and Regeneron, as amended by Sections 4.2(b) and 4.4 of the Investor Agreement, and as may be further amended from time to time. 1.10 "BLA" shall mean, with respect to each Licensed Product, a biologics license application filed with respect to such Licensed Product, as described in the FDA regulations, including all amendments and supplements to the application, and any equivalent filing with any Regulatory Authority. 1.11 "Business Day" shall mean any day other than a Saturday, a Sunday or a day on which commercial banks in New York, New York, the United States or Paris, France are authorized or required by Law to remain closed. 1.12 "Clinical Supply Cost" shall mean (a) the Out-of-Pocket Cost for purchasing and/or the Manufacturing Cost to Manufacture Formulated Bulk Product for Clinical Supply Requirements under the applicable Global Development Plan, (b) the Out-of-Pocket Cost for purchasing and/or the Manufacturing Cost to Manufacture, comparator agent or placebo requirements for ...
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Anticipated First Commercial Sale means, with respect to a Licensed Product in the Field, on a
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Anticipated First Commercial Sale means, with respect to a Co-Funding Product, the date agreed upon in advance by the JSC as the expected date of First Commercial Sale of such Co-Funding Product in such country or Region (as applicable) of the world if specified or, otherwise, any country in the world. [***].
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Anticipated First Commercial Sale means, with respect to a Product, the date projected by Roche as the expected date of First Commercial Sale of such Product in a country.
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Anticipated First Commercial Sale means, with respect to a Licensed Product in the Field, on a country- by-country basis in the Territory, the date agreed upon by the JSC in advance as the expected date of First Commercial Sale of such Licensed Product in the Field in such country in the Territory.
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Related to Anticipated First Commercial Sale

  • First Commercial Sale means the first sale for use or consumption of any Licensed Product in a country after all required Regulatory Approvals for commercial sale of such Licensed Product have been obtained in such country.

  • Commercial Sale means the sale of Product (as indicated by shipment of Product) to an unaffiliated third-party of the Licensee, or of its sublicensee or distribution partner, such as a wholesaler, managed care organization, hospital or pharmacy and shall exclude (i) any transfer of Product by Licensee to its sublicensee, distribution partner or Affiliate and (ii) any distribution of Product for use in research, development, pre-clinical and clinical trials.

  • Commercial cannabis activity means the production, cultivation,

  • Commercial Launch means the initial First Commercial Sale of a Product in the Territory.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Distribution Commencement Date means the Issue Date or such other date as may be specified as the Distribution Commencement Date on the face of such Perpetual Security;

  • ESBD means the Electronic State Business Daily, the electronic marketplace where State of Texas bid opportunities over $25,000 are posted. The ESBD may currently be accessed at http://www.txsmartbuy.com/esbd.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • designated sporting event generally means any association football match, whether national or international. The full legal definition of the different classes of designated sporting events may be found in the Sports Grounds and Sporting Events (Designation) (Amendment) Order 2011, under Article 2(1) and 2(2) of Schedule 2.

  • Commencement of Commercial Production means: (i) if a mill is located on the Property, the last day of a period of 40 consecutive days in which, for not less than 30 days, the mill processed ore from the Property at 60% of its rated concentrating capacity; or (ii) if a mill is not located on the Property, the last day of a period of 30 consecutive days during which ore has been shipped from the Property on a reasonably regular basis for the purpose of earning revenues, but any period of time during which ore or concentrate is shipped from the Property for testing purposes, or during which milling operations are undertaken as initial tune-up, shall not be taken into account in determining the date of Commencement of Commercial Production;

  • Commercial or marketing purpose means the sale of student data; or its use or disclosure for purposes of receiving remuneration, whether directly or indirectly; the use of student data for advertising purposes, or to develop, improve, or market products or services to students.

  • Development means any man-made change to improved or unimproved real estate, including, but not limited to, buildings or other structures, mining, dredging, filling, grading, paving, excavation or drilling operations, or storage of equipment or materials.

  • Offering Commencement Date means the first day of each Offering Period.

  • Expected week of childbirth means the week, starting on a Sunday, during which the mother's doctor or midwife expects her to give birth.

  • Commercial sexual activity means any sex act or sexually explicit performance for which anything of value is given, promised to, or received by any person and includes, but is not limited to, prostitution, participation in the production of pornography, and performance in strip clubs.

  • Anticipated Closing Date means the anticipated closing date of any proposed Qualified Sale Transaction, as determined in good faith by the Board of Directors on the Applicable Date.

  • Investment Start Date : means 19 November 2021 or if such day is not a Scheduled Trading Day, the following day which is a Scheduled Trading Day.

  • Commercial Operation Date means the date on which a Material Project is substantially complete and commercially operable.

  • Cannabis production establishment agent means a cannabis cultivation facility

  • Commercial Operations Date or "COD": The date on which Facility first achieves Commercial Operations.

  • Roll coating means the application of a coating material to a substrate by means of hard rubber or steel rolls.

  • Total trihalomethanes (TTHM) means the sum of the concentration in milligrams per liter of the trihalomethane compounds: trichloromethane (chloroform), dibromochloromethane, bromodichloromethane, tribromomethane (bromoform), rounded to two significant figures after addition.

  • Medical cannabis card means the same as that term is defined in Section 26-61a-102.

  • Participating Home Infusion Therapy Provider means a Home Infusion Therapy Provider who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • commercial fishing means to take, harvest, hold, transport, or off-load marine species for sale or intended sale (R.I. Gen. Laws § 20-1-3).

  • Benchmark Transition Start Date means, in the case of a Benchmark Transition Event, the earlier of (a) the applicable Benchmark Replacement Date and (b) if such Benchmark Transition Event is a public statement or publication of information of a prospective event, the 90th day prior to the expected date of such event as of such public statement or publication of information (or if the expected date of such prospective event is fewer than 90 days after such statement or publication, the date of such statement or publication).