Commercialization Year definition

Commercialization Year means with respect to each Selected Compound, the twelve (12) month periods beginning the first day of the calendar quarter immediately following commencement of the applicable Commercialization Period and each twelve (12) month period thereafter.
Commercialization Year shall have the meaning given in Section 3.1.4.
Commercialization Year means the one year period from the First Commercial Sale, and each annual period thereafter. 1.3 “Dosage Strength” means the 0xx, 0.0xx, 10mg, 12.5 mg, 15mg, 17.5mg, and 20mg dosage strengths of the Product. 1.4 “Field” means the treatment of prolonged or acute, convulsive seizures in all ages, or such other definition that is consistent with the foregoing and agreed upon in good faith by the Parties in writing). 1.5 “Product” means diazepam buccal film. 1.6 “Manufacturing Facility” means, as of the Effective Date, Aquestive’s manufacturing site located at 0000 Xxxxxxxxx Xxxxx, Xxxxxxx, Xxxxxxx (XX) 00000, Xxxxxx Xxxxxx (XXX), FDA Establishment Number 0000000000. 1.7 “Territory” means: (i) the countries of the European Union (as of the Effective Date), Sweden, Switzerland and Norway; (ii) the United Kingdom (England, Scotland, Wales and Northern Ireland); and (iii) the Middle East and North Africa (Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Qatar, Saudi Arabia, Syria, Tunisia, United Arab Emirates and Yemen).

Examples of Commercialization Year in a sentence

  • The Parties shall, after the 5th Commercialization Year, negotiate in good faith to adjust the Base Minimum Purchase Levels as set out in this Section 6, with effect from the 6th Commercialization Year until 2014, provided that such adjustment is reasonable taking into account major developments in the macro-economic environment since the signing of this Agreement.

  • Consistent with prior research, we expect that the effect of Commercialization Year on the probability of take-off is positive.World War 2.

  • Provided that PRONOVA is not in breach of its supply obligations under Section 5, this Agreement will be subject to RELIANT making at least the following purchases of API for Trade Product (the “Base Minimum Purchase Levels”) during the first twelve month period following the First Commercial Sale and every 12-month period thereafter (each a “Commercialization Year”): • 1st Commercialization Year: USD 6,000,000.

  • DISTRIBUTOR shall not sell any Agreement Products beyond their stated expiration date; provided, however, EVOLUS shall only deliver Agreement Products to DISTRIBUTOR that have: (a) during Commercialization Year 1 at least [***] months of their useful life remaining and (b) after Commercialization Year 1 at least [***] years of their useful life remaining.

  • During Commercialization Year 1, DISTRIBUTOR may expressly enter into Bundle Agreements with a maximum term of three years and EVOLUS shall have the obligations to deliver the Agreement Products at the Transfer Price set forth on Exhibit C regardless of whether the Term of this Agreement has ended.

  • The Minimum Purchase Level may be reached by RELIANT by purchasing API for Sample Product at the price for Trade Product, or by paying the difference between actual Trade Product bought during the respective Commercialization Year and the Minimum Purchase Level in that year.

  • Notwithstanding the foregoing, after the first Commercialization Year which includes a full calendar year, Xxxxxxx'x minimum royalty obligation shall be calculated on Forecast Net Sales in an amount not less than * of Xxxxxxx actual Net Sales in the previous Commercialization Year.

  • Xxxxxxx shall deliver to DTI, not later than forty-five (45) days prior to launch of the Initial Product in such country, and thereafter on or before November 15 of each calendar year its projected Net Sales of Licensed Products in the Territory for the relevant Commercialization Year.

  • Notwithstanding Section 9.3 above, after the completion of Commercialization Year 1 and at any time Evolus may determine thereafter, Evolus, at its sole discretion, may allow DISTRIBUTOR to enter into multi-year “bundling” agreements (“Bundle Agreements”) with customers of the Agreement Products in the Territory whereby customers would purchase a bundle of products that include the Agreement Products.

  • Provided that PRONOVA is not in breach of its supply obligations under Section 5, this Agreement will be subject to RELIANT making at least the following purchases of API for Trade Product during the first twelve month period following the First Commercial Sale and every 12-month period thereafter (each a “Commercialization Year”) prior to Full Regulatory Approval (the “Reduced Base Minimum Purchase Levels”): • 1st Commercialization Year: USD 3,000,000.


More Definitions of Commercialization Year

Commercialization Year means the one-year period from the First Commercial Sale, and each annual period thereafter. 1.3 “Dosage Strength” means the 5mg, 7.5mg, 10mg, 12.5 mg, 15mg, 17.5mg, and 20mg dosage strengths of the Product. 1.4 “Field” means the treatment of (i) prolonged or acute, convulsive seizures in all ages, or such other definition that is consistent with the foregoing and agreed upon in good faith by the Parties in writing, and (ii) the medical indications set forth in Pharmanovia’s present approved label for Valium™(diazepam) in all territories, including those where there is currently not a Valium approved product. 1.5 “Product” means diazepam buccal film. 1.6 “Manufacturing Facility” means, as of the Effective Date, Aquestive’s manufacturing site located at 0000 Xxxxxxxxx Xxxxx, Xxxxxxx, Xxxxxxx (XX) 00000, Xxxxxx Xxxxxx (XXX), FDA Establishment Number 3004395604. 1.7 “Territory” means all of: 1.
Commercialization Year means a period of twelve (12) consecutive months which, for the first Commercialization Year of this Agreement, shall commence on the first day of the month after the month of MediciNova’s first bona fide commercial sale (“Product Launch”) of Products to a non-Affiliate customer after the Products have received an approved NDA from the FDA or [***] and each Commercialization Year thereafter shall consist of twelve (12) consecutive months following the end of the preceding Commercialization Year.

Related to Commercialization Year

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Commercialization Costs means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

  • Development Plan has the meaning set forth in Section 3.2.

  • Development Period means the period from the date of this Agreement until the Appointed Date;

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

  • Research Period means the research period as described in the Commissioned Research Plan. In accordance with the provisions of this Agreement, in the event that the Agreement ended prior to the completion date of the research originally set, the date the Agreement ends shall be read as the research period.

  • Research Budget has the meaning set forth in Section 2.2.

  • Sales Year means the calendar year during which the Company sold Cigarettes in a Beneficiary State requiring the deposit of QEF Principal.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Calendar Year means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.

  • Annual Net Sales means, with respect to any Calendar Year, the aggregate amount of the Net Sales for such Calendar Year.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • Collaboration Term has the meaning set forth in Section 2.1(h).

  • Promotion Period means the period the Promotion is open, as specified in clause 5.1.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Development Program means the implementation of the development plan.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Research Program Term has the meaning set forth in Section 2.2.

  • Research Program has the meaning set forth in Section 3.1.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Annual Work Plan and Budget means the work plan and budget approved by the Bank and adopted by the Borrower in accordance with the provisions of Section I.C of Schedule 2 of this Agreement, as said work plan and budget may be modified from time to time with the written agreement of the Bank.