Distinct Product definition

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 has the meaning given in Section 2.6(a)(ii).

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.

Examples of Distinct Product in a sentence

• 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.

• 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.

• Celgene will make any Distinct Product Catch-Up Payments within [***] days after such Distinct Product receives Regulatory Approval in the United States.

• Each Distinct Product shall separately be subject to the applicable payment provisions for Distinct Products set forth in each applicable Development & Commercialization Agreement.

• For each Joint Development Program (and potentially, for each Distinct Product within a given Joint Development Program), the Lead Party shall prepare a Joint Development Plan based upon the plan and budget in the Preliminary Development Package and in accordance with Section 5.4(b) and present such Joint Development Plan to the JDC within [***] of the formation of the JDC (or extension of oversight to an existing JDC).

• During the Royalty Term, iBio shall pay to RubrYc tiered royalties as calculated by multiplying the applicable royalty rate set forth in the table below by the corresponding amount of incremental, aggregated Net Sales of a Collaboration Product (including each Distinct Product) in a Program in the Territory in a Calendar Year (a “Royalty Payment”).

• 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).

• Each of the recurring milestone payments set out in the table below shall be payable only once with respect to each Distinct Product regardless of whether the corresponding milestone is achieved more than once.

• If Cell Medica conducts phase I clinical trial activities with respect to a Distinct Product, Baylor will be (unless Baylor notifies Cell Medica 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 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.

Distinct Product is defined in Section 1.23 (Collaboration Product).

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;