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.
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Commercialization Year shall have the meaning given in Section 3.1.4.
Sample 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.
Sample 1

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.

  • The Parties agree if the Minimum Volume Commitment in Commercialization Year 5 is less than in Commercialization Year 4, to discuss the Product Transfer Price in good faith.

  • The royalty fee for Products and Additional Products shall be payable to PRONOVA on a semi-annual basis, so that the fee for the first six (6) months of each Commercialization Year is payable thirty (30) days after the end of this period, and the fee for the last six (6) [***]: Certain information on this page has been omitted and filed separately with the Commission.

  • 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.

  • 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.

  • 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.

  • The amount due under this Section 8.5 for any Commercialization Year is the amount, if any, by which the MARs specified for the applicable Minimum Annual Royalty Category for that Commercialization Year period exceeds the royalties actually paid on Beverages and Beverage Bases incorporating Selected Compounds with respect to the applicable Minimum Annual Royalty Category during such Commercialization Year (“Royalty Shortfall(s)”).

  • 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.

  • 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.

  • Within [***] days of the Effective Date, DISTRIBUTOR shall provide to EVOLUS a non-binding forecast for the Initial Agreement Products for Commercialization Year 1.


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: 1.7.1 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) (the “Original Territories”); and 1.7.2 all of the countries in the world excluding the Original Territories, USA, Canada, and China (the “Extension Territories”). 2.
Sample 1
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). 2.
Sample 1

Related to Commercialization Year

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

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Commercialization Costs means the sum of the following costs and expenses incurred by the Parties or their respective Affiliates, in Commercializing the Shared Products (and related Manufacturing activities) in the Territory, in each case, to the extent incurred in accordance with the Commercialization Plan and Commercialization Budget:

  • 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 2.1(a).

  • 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 4.2.

  • 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, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Calendar Year means each successive period of twelve (12) months commencing on January 1 and ending on December 31.

  • 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 specified in Section 2.1.2 hereof.

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

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

  • 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 2.1.

  • 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.