Chemical Entity definition

Chemical Entity means any active chemical compound, molecular entity or moiety that is: (a) covered by any Valid Claim of any Licensed Patent or Separately-Licensed Patent; or (b) licensed by a Party to the other Party under this Agreement and with respect to which Regulatory Exclusivity exists.
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Examples of Chemical Entity in a sentence

  • In addition, TESARO will use Commercially Reasonable Efforts to secure any data and market exclusivity, including New Chemical Entity exclusivity, for a Licensed Product for which Marketing Approval is obtained to the extent available from the applicable Regulatory Authorities.

  • The covenant set forth in this Section 14.8.2 shall not extend to activities by VI, its Affiliates, or its Licensees (i) for products not within the Field of Use, or (ii) involving the use of a Novel Chemical Entity in a product.

  • DS is typically manufactured by either chemical/enzymatic reactions (Chemical Entity) or cell culture/fermentation processes (Biological Entity) and purification step(s).

  • Orchid is the only Indian pharmaceutical company ever to have invented a New Chemical Entity (NCE, also colloquially called New Drug) which has cleared global clinical phase III trials.

  • In order to maintain the Exclusive NCE status of a particular Chemical Entity, the applicable Party must initiate (i.e., administration of the first dose to the first patient) a First in Human Clinical Trial with respect to such Chemical Entity within [***] of the date of the IND filing that caused such Chemical Entity to become an Exclusive NCE.

  • Prior to or with U.S. Marketing Approval, the FDA shall not have withdrawn orphan drug status for Pacritinib (“ODD”) and Seller shall not have been notified by the FDA of any impediment to Seller’s marketing exclusivity associated with the ODD or New Chemical Entity exclusivity.

  • Array hereby grants to Vertex a perpetual, compensation-free, non-exclusive license, without the right to sublicense, under Licensed Technology to make, have made and use Compounds to make, have made and use any Inactive Chemical Entity for Vertex's own internal research purposes (on its own or through a Third Party on behalf, or under the authority, of Vertex).

  • No chemical entity synthesized by Array directed to such De-Selected Target after the effective date of the written notice to discontinue research activities with respect to such De-Selected Target shall be deemed to be a Compound or Inactive Chemical Entity under this Agreement.

  • In addition, if a Party at any time determines to cease all efforts to develop and commercialize an Exclusive NCE of such Party, then such Party shall provide written notice to the other Party of such determination, and upon such notice the applicable Chemical Entity shall cease to be an Exclusive NCE of such Party.

  • Upon compliance by a Party with the Exclusive NCE Requirements with respect to a Chemical Entity, such Chemical Entity shall be deemed an Exclusive NCE of such Party.