Product Development and Commercialization Activities definition

Product Development and Commercialization Activities means, with respect to any Product, any combination of research, development, manufacture, import, use, sale, importation, storage, labeling, marketing, promotion, supply, distribution, testing, packaging, purchasing or other commercialization activities, receipt of payment in respect of any of the foregoing, or like activities the purpose of which is to commercially exploit such Product.
Product Development and Commercialization Activities means, with respect to the Product, any combination of research, development, manufacture, import, use, sale, go-to market plans, the development of customer and revenue projections, financing plans pricing strategy, product positioning, board-approved operating budgets, Product Authorizations, supply, distribution, testing, packaging, purchasing or other commercialization activities, receipt of payment or financing in respect of any of the foregoing, or like activities and plan (each in form and substance satisfactory the Administrative Agents and the Lenders), the purpose of which is to commercially exploit such Product.
Product Development and Commercialization Activities means, with respect to the Product, any combination of research, development, manufacture, import, use, sale, go-to market plans, the development of customer and revenue projections, financing plans pricing strategy, product positioning, board-approved operating budgets, Product Authorizations, supply, distribution, testing, packaging, purchasing or other commercialization activities, receipt of payment or financing in respect of any of the foregoing, or like activities and plan (each in form and substance satisfactory to the Collateral Agent and the Required Holders), the purpose of which is to commercially exploit such Product.

Examples of Product Development and Commercialization Activities in a sentence

  • All required notices, registrations and listings, supplemental applications or notifications, reports (including reports of adverse experiences) and other required filings with respect to all material Products have been filed with the FDA, the DEA, and all other applicable Regulatory Agencies when due, except where the failure to do so could not reasonably be expected to result in a material adverse effect on any Product Development and Commercialization Activities.

  • All required and material notices, registrations and listings, supplemental applications or notifications, reports (including annual reports, field alerts, Device reports or other reports of adverse experiences) and all other required and material filings with respect to the Products or any related Product Development and Commercialization Activities have been filed with the FDA, WHO, XX-Xxxx EMA, HPRA, Health Canada, ANVISA and all other applicable Governmental Authorities.

  • Each Obligor adheres in all material respects to all applicable regulations of all Regulatory Authorities with respect to its Products and all Product Development and Commercialization Activities related thereto.

  • All required and material notices, registrations and listings, supplemental applications or notifications, reports (including annual reports, field alerts, Device reports or other reports of adverse experiences) and all other required and material filings with respect to the Products or any related Product Development and Commercialization Activities by such Obligor have been filed with the FDA and all other applicable Governmental Authorities.

  • Financial assetsPerusahaan dan entitas anak mengklasifikasikan aset keuangannya ke dalam salah satu kategori yang dijelaskan di bawah ini, tergantung pada tujuan pengakuisisian aset.The Group classifies its financial assets into one of the categories discussed below, depending on the purpose for which the asset was acquired.

  • Each Obligor adheres in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities by such Obligor related thereto.

  • To the Loan Parties’ knowledge, neither the Borrower nor any of the Subsidiaries has taken any action that would permit any other Person party to any such license agreement to have, and no such Person otherwise has, any defenses, counterclaims or rights of setoff thereunder (1) as of the Closing Date and (2) after the Closing Date, that could reasonably be expected to result in a material adverse effect on any Product Development and Commercialization Activities.

  • Comply with each Material Contract of such Person, except where the failure to so comply could not reasonably be expected, either individually or in the aggregate, to have a material adverse effect on any Product Development and Commercialization Activities.

  • E.P.S. is responsible for providing any labor, materials and supplies above what SCCPSS is committing to provide in this Agreement.

  • None of the Borrower nor any of its Subsidiaries has taken or failed to take any action that would permit any other Person party to any Material Contract to have, and, to the knowledge of any Loan Party, no such Person otherwise has, any defenses, counterclaims or rights of setoff thereunder (1) as of the Closing Date and (2) after the Closing Date that could reasonably be expected to result in a material adverse effect on any Product Development and Commercialization Activities.


More Definitions of Product Development and Commercialization Activities

Product Development and Commercialization Activities means, with respect to any Product, any (i) research, development, manufacture, compliance, importation, exportation shipping, use, sale, storage, design, labeling, marketing, promotion, supply, distribution, testing, packaging, licensing, purchasing or other commercialization activities, (ii) receipt of payment or other remuneration in respect of any of the foregoing (including, without limitation, in respect of any licensing, royalty or similar payments), or (iii) any like or other activities the purpose of which is to commercially exploit any such Product.
Product Development and Commercialization Activities means, with respect to any Product, one or any combination of research, development, manufacture, import, use, sale, importation, storage, labeling, marketing, promotion, supply, distribution, testing, packaging, purchasing or other commercialization activities, receipt of payment in respect of any of the foregoing, or like activities the purpose of which is to develop or commercially exploit such Product. “Product Rights” means any and all rights in Intellectual Property owned or licensed by any Credit Party or Subsidiary related to Daxi or Product Development and Commercialization Activities related to Daxi. “Public Issuer Materials” has the meaning set forth in Section 7.02. “Purchasers” means each of the Persons identified as a “Purchaser” on the signature pages hereto and their successors and assigns. “Purchasers Fee Letter” means that certain amended and restated letter agreement dated as of the First Amendment Effective Date among the Issuer, on the one hand, and the Purchasers and/or one or more of their respective Affiliates, on the other hand. “Purchasing Office” means, as to any Purchaser, the office address of such Purchaser and, as appropriate, account of such Purchaser set forth on Schedule 11.02 or such other address or account as such Purchaser may from time to time notify the Issuer and the Administrative Agent. “Qualified Capital Stock” of any Person means any Equity Interests of such Person that are not Disqualified Capital Stock. “Qualified Equity Issuance (Litigation)” means, with respect to any Specified Litigation, any issuance of the Issuer’s Qualified Capital Stock occurring on or after the date that is six (6) months prior to the final settlement, final non-appealable judgment or other final resolution of such Specified Litigation. “Qualified Equity Issuance (Acquisition) Proceeds” means the net cash proceeds received by the Issuer from any issuance of the Issuer’s Qualified Capital Stock; provided, that, such net cash proceeds are Not Otherwise Applied. “Qualified Equity Issuance (Litigation) Proceeds” means, with respect to any Specified Litigation, the net cash proceeds received by the Issuer from any Qualified Equity Issuance (Litigation) in connection therewith; provided, that, a Responsible Financial Officer of the Issuer shall have delivered a certificate to the Administrative Agent (in form and substance reasonably satisfactory to the Required Purchasers) certifying that (a) such net cash proceeds are Not Otherwise Applied...
Product Development and Commercialization Activities means, with respect to any existing or future Product that the Borrower or any of its Subsidiaries is selling, distributing, marketing, promoting or otherwise commercializing (or intends to sell, distribute, market, promote or otherwise commercialize), any combination of (i) research, development, manufacture, quality compliance, importation, use, sale, storage, design, labeling, marketing, promotion, supply, distribution, testing, packaging, licensing, purchasing or other commercialization activities, (ii) receipt of payment or other remuneration in respect of any of the foregoing (including, without limitation, in respect of any licensing, royalty or similar payments), or (iii) any like or other activities the purpose of which is to commercially exploit any such Product.
Product Development and Commercialization Activities. MEANS, WITH RESPECT TO ANY PRODUCT, AND TO THE EXTENT APPLICABLE TO THE OBLIGORS,COMBINATION OF RESEARCH, DEVELOPMENT, MANUFACTURE, USE, SALE, LICENSING, IMPORTATION, STORAGE, DESIGN, LABELING, MARKETING, PROMOTION, SUPPLY, DISTRIBUTION, TESTIN PACKAGING, PURCHASING OR OTHER COMMERCIALIZATION ACTIVITIES, RECEIPT OF PAYMENT IN RESPECT OF ANY OF THE FOREGOING (INCLUDING, WITHOUT LIMITATION, IN RESPECTlicensing, royalty or similar payments), or any similar or other activities the purpose of which is to commercially exploit such Product.

Related to Product Development and Commercialization Activities

  • 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.

  • Development Activities means those Development activities undertaken by or on behalf of a Party or its Affiliates with respect to the Product in the Field.

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

  • Development Program means the implementation of the development plan.

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

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

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

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

  • 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.

  • 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.

  • Collaboration has the meaning set forth in Section 2.1.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

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

  • Development Work means all work and services necessary or desirable in connection

  • Research means a methodical investigation into a subject.

  • 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;

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 2.1(a).

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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.

  • licensed activities means things authorised to be done by the licence

  • 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)).

  • Research Program Term means the duration of the Research Program as it may be extended or terminated as described more fully in Section 2.10 and Article 8.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • 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.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.