Distinct Product definition

Distinct Product has the meaning given in Section 2.6(a)(ii).
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Distinct Product means, solely with respect to any [***], following Regulatory Approval in the United States for the first (1st) Program Product in such Program (the “Initially-Approved Product”), any other Program Product in such Program (i.e., other than the Initially-Approved Product) that receives Regulatory Approval in the United States with a product label with an entirely separate and non-overlapping Indication from the Indication contained in the then-existing product label for the Initially-Approved Product (based upon distinct substantiating evidence obtained from Functional Phenotypic Assay Similarity Criteria results for the Compound(s) included in each such Program Product demonstrating utility in distinct Indications where the later-approved Program Product could not be substituted for the Initially-Approved Product for the same Indication) (each such later-approved Product, an “Other Distinct Product”); it being understood and agreed that, for clarity, if the foregoing conditions are met, each Initially-Approved Product and Other Distinct Product in the same Program shall be deemed to be “Distinct Products” for purposes of this Agreement and any Development & Commercialization Agreement, as applicable.
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Distinct Product is a Licensed Product for which a separate and distinct Investigational New Drug (IND) application or Biologics License Application (BLA), or their non-US equivalents, is required by a regulatory authority to be filed with respect thereto to clinically develop in humans and obtain approval to market such product. For the avoidance of doubt, any combination product comprising a Licensed Product on the one hand, and another active agent (whether or not another Licensed Product), on the other hand, shall be deemed to be a Distinct Product separate from any such Licensed Product, if the combination product is subject to a separate and distinct IND or BLA, or their non-US equivalents. For further avoidance of doubt, a Licensed Product which is administered as a concurrent therapy (and not a combination product) along with another product which contains a different active agent, wherein each product is subject to a separate IND or BLA (or their non-US equivalents), shall not be considered a different Distinct Product from the Licensed Product when administered alone.
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Examples of Distinct Product in a sentence

  • In case SPV is not available in the cluster, the scheme may be availed through another legal entity i.e. concerned association by grouping the MSMEs in the form of Distinct Product Groups (DPGs) or Sub Groups.

  • In Mongolia, there is no independent body which has a legal status similar to a National Committee on Human Rights and tackles gender-based discrimination.

  • A Comparison with the Distinct Product Test in U.S. Antitrust Law In U.S. antitrust law, the tying and tied products are separate if “the tying item is commonly sold separately from the tied item in a well functioning market.”167 The test is whether there is sufficient consumer demand in the marketplace to support independent markets despite any efficiencies tying may bring.

  • The Distinct Product Test and the Boundaries of the Bundling Antitrust Category This is not the only function of the distinct product inquiry.

  • For the avoidance of doubt, a separate Milestone Payment and separate Royalties shall be owed for a different Distinct Product even if such Distinct Product and one or more other Distinct Products utilize, or are covered by the same Technology Rights.

  • If any goods or services being provided by a retailer in connection with the sale and/or installation of a manufactured home, the retailer must disclose, in writing, the goods and/or services to be provided and a good faith estimate as to when they will be provided.

  • Notwithstanding anything contained herein to the contrary, each Milestone Payment shall only (A) apply to the first Distinct Product to achieve (if any) each Milestone Event specified in the Milestone Chart, and (B) be payable once regardless of the number of Distinct Products to achieve such Milestone Event.

  • Celgene will make any Distinct Product Catch-Up Payments within [***] days after such Distinct Product receives Regulatory Approval in the United States; provided, however, that, Milestone 4 above shall instead only be payable [***] days after such Distinct Product receives Regulatory Approval in the European Union.

  • Fourth, if the condition is not the equivalent to a listed impairment, the claimant must show that he cannot perform his past work, and the ALJ must assess the claimant’s residual functional capacity (“RFC”).

  • If Kuur conducts phase I clinical trial activities with respect to a Distinct Product, Baylor will be (unless Baylor notifies Kuur that it does not want to be) the lead clinical center, select the chief (lead) investigator and will be entitled to first and last authorship academic credit with respect to such Early R&D Activities, subject to the terms and conditions of this Agreement and the License and Option Agreement (including Section 17.5 therein).


More Definitions of Distinct Product

Distinct Product is defined in Section 1.23 (Collaboration Product).
Sample 1
Distinct Product means a Product for which a separate and distinct IND application or BLA, or their non-US equivalents, is required by a Regulatory Authority to be filed with respect thereto to clinically develop in humans and obtain approval to market such product. If a Product covers more than one Indication, each Product shall be treated as a Distinct Product for each Indication. For the avoidance of doubt, any combination product comprising a Product on the one hand, and another active agent (whether or not another Product), on the other hand, shall be deemed to be a Distinct Product separate from any such Product, if the combination product is subject to a separate and distinct IND or BLA, or their non-US equivalents. For further avoidance of doubt, a Product which is administered as a concurrent therapy (and not a combination product) along with another product which contains a different active agent, wherein each product is subject to a separate IND or BLA (or their non-US equivalents), shall not be considered a different Distinct Product from the Product when administered alone;
Sample 1
Distinct Product means, with respect to a first Product, a second (or subsequent) Product (a) that is directed to the same Target as the first Product, (b) that contains a different therapeutically active chemical entity or composition of matter from the first Product (e.g., for a small molecule, is a different “new chemical entity” which is not a salt form or stereoisomer variant of a Compound contained in the first Product, and for an antibody, is based on a different polypeptide sequence), and (c) that is or is intended to be the subject of an application for Regulatory Approval (which may include a label expansion) for a different indication from the first Product.
Sample 1

Related to Distinct Product

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Bundled Product means Product sold together with any other product(s) or service(s) at a single unit price, whether packaged together or separately, and which other product(s) or service(s) have material independent value from Product itself.

  • Combination Product means any product that comprises a Licensed Compound or Licensed Product sold in conjunction with another active component so as to be a combination product (whether packaged together or in the same therapeutic formulation).

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Combination Products means any product containing both a pharmaceutically active agent or ingredient which constitutes a Licensed Product and one or more other pharmaceutically active agents or ingredients which do not constitute Licensed Products.

  • Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Hemp products means all products made from industrial hemp,

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Generic Product means any pharmaceutical product that (i) is sold by a Third Party that is not an Affiliate or licensee of Buyer and (ii) (a) contains the same active pharmaceutical ingredient as the Product or (b) is categorized by the applicable Governmental Entity in a country to be therapeutically equivalent to, or interchangeable with, the Product, such that the pharmaceutical product may be substituted for the Product at the point of dispensing without any intervention by the prescribing physician in such country.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Other Product means Product which an End User acquired from sources other than Integrator.

  • Licensed producer means a person or entity licensed to produce medical cannabis.

  • Recycled product means a product containing recovered material, or post-consumer recovered material, or both.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • 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.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Licensed System means, collectively:

  • Cannabis products means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.