Existing Licensed Product definition

Existing Licensed Product is defined in Section 12.3(d).
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Existing Licensed Product means (a) a Licensed Product comprising or containing TSK011010 alone or in combination with one or more active ingredients, or (b) a Lyophilized Product, alone or in combination with one or more active ingredients, in each case ((a) and (b)), in any and all forms, presentations, formulations, dosages, dosage forms, and strengths, including any line extensions of any of the foregoing, but excluding any Next Generation Licensed Product.
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Existing Licensed Product means the pharmaceutical product known as E7777, containing the Licensed Compound as an active ingredient and described in IND #110489.
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Examples of Existing Licensed Product in a sentence

  • Trustee’s sole rights with respect to transferability or use of Licensed Products shall be to exclusively sublicense to Authorized User all of its Licensee’s rights under the terms and conditions of the License Agreement; provided, further, however, in the event of any termination or expiration of such sublicense by reason of payment in full, all of Trustee’s rights in such Licensed Product shall terminate immediately and Authorized User’s prior rights to such Existing Licensed Product shall be revived.

  • Trustee’s sole rights with respect to transferability or use of Licensed Products shall be to exclusively sublicense to Authorized User all of Lessor’s rights under the terms and conditions of the License Agreement; provided, further, however, in the event of any termination or expiration of such sublicense by reason of payment in full, all of Trustee’s rights in such Licensed Product shall terminate immediately and Authorized User’s prior rights to such Existing Licensed Product shall be revived.

  • Notwithstanding anything in this Agreement to the contrary, the provisions of this Section 5.7 shall not apply to regulatory submissions or Regulatory Approvals for New Licensed Product or New Indication Existing Licensed Product that a Party Develops pursuant to, and in accordance with, Section 5.11 or Section 5.12, which such regulatory submissions and Regulatory Approvals shall be the sole responsibility of and solely owned by such Party.

  • The Parties acknowledge their respective regulatory responsibilities set forth in Article 8 and elsewhere herein, and agree otherwise to work together to develop the Existing Licensed Product for the First Indication in accordance with the Development Plan and for the Second Indication in accordance with the Second Indication Development Plan.

  • As used herein, a “Reverted Licensed Product” means both such Licensed Product in the form it exists as of the effective date of termination (the “Existing Licensed Product”), as well as a modified version of such Licensed Product which contains the same Islet Cells as are in the Existing Licensed Product, but which includes a formulation of the Encapsulation Material which is a [***] included in the Existing Licensed Product, which such [***] but disclosed to Lilly in an appropriately documented manner.

  • The Development Milestone Payments set forth in TABLE 6.3.1(b) (Development Milestones for Existing Licensed Products) will be payable one-time in accordance with Section 6.3.1(f) (Notice and Payment) upon the achievement of the applicable Development Milestone Event by the first Existing Licensed Product.

  • On a region-by-region basis, CASI will make the Sales Milestone Payments to Black Belt upon the achievement by CASI or its Affiliates or Sublicensees of each of the Sales Milestone Events for the applicable region set forth in TABLE 5.3.2(a) (Existing Licensed Product Sales Milestones) below with respect to the aggregate annual Black Belt Net Sales of Existing Licensed Products in each applicable region.

  • At any time prior to the filing of a Drug Approval Application for the Exploitation of the Existing Licensed Product in the United States (the “India Option Period”), the Licensee may, upon [***] ([***]) Business Days’ written notice to Eisai elect to add India to the Licensee Territory (the “India Option”).

  • Promptly following the BLA filing, Eisai shall assign and shall cause its Affiliates to assign, to the Licensee all of Eisai’ s and its Affiliates’ rights, title and interest in and to any INDs with respect to the Existing Licensed Product in the Licensee Territory and all related Regulatory Documentation with respect thereto.

  • In accordance with the Development Plan and any Development Amendment, at its sole expense, under the oversight of the JDC, Licensor shall retain control and responsibility for all regulatory submissions for the Existing Licensed Product in the Field in the Territory with respect to obtaining the Initial Approval.


More Definitions of Existing Licensed Product

Existing Licensed Product means the pharmaceutical product containing landiolol in a [***], as further described in Exhibit 1.43.
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Existing Licensed Product means the Licensed Product being Developed by Anaptys as of the Effective Date comprising the Existing Licensed Compound. 1.44 “Existing Product” has the meaning set forth in Section 3.1.5. 1.45 “External Costs” means, with respect to a Party, all external costs and expenses actually and reasonably incurred by a Party or its Affiliate in performing the relevant activity(ies), including costs of materials (including taxes and duties thereon, but without markup) and Third Party contract costs (such as contract costs with Third Party consultants, subcontractors and vendors) to perform the relevant activity(ies), but excluding any (a) capital expenditures and financing costs, and (b) employee salaries and benefits. 1.46 “FDA” means the United States Food and Drug Administration or any successor entity thereto. 1.47 “FFDCA” means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as may be amended from time to time. 1.48 “Field” means therapeutic or diagnostic uses for the treatment or palliation of diseases in humans. 1.49 “First Commercial Sale” means, with respect to a Licensed Product and country, the first sale of such Licensed Product by or on behalf of Licensee, its Affiliates or Sublicensees to a Third Party for distribution, use or consumption in such country after all Regulatory Approvals (excluding Pricing and Reimbursement Approvals) have been obtained for such Licensed Product in such country. For clarity, the sale of a Licensed Product for promotional use (including samples), use in Clinical Trials or other Development activities, compassionate use, named patient sales, international pharmacy sales, patient assistance programs or other early access programs, in each case at or below cost, shall not constitute a First Commercial Sale. 1.50 “Force Majeure” has the meaning set forth in Section 10.6. 1.51 “FTE” means an individual employee of Anaptys or its Affiliates (for clarity, excluding Third Party consultants). 1.52 “FTE Costs” means, for any period and activities, the product obtained by multiplying (a) the total hours devoted by FTEs to the performance of such activities during such period, by (b) the FTE Rate. 1.53 “FTE Rate” means a rate of [***] per hour. As between the Parties, the Party employing such FTE will be solely responsible for the payment of all compensation to such FTE, as well as for the payment of all withholding taxes, social security, workers’ compensation,
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Existing Licensed Product means the Licensed Product(s) contemplated by IND # [REDACTED], as amended, which Licensed Product(s) are formulated, composed and administered under a dosing regimen consistent with such IND and which are undergoing Phase IIIA Clinical Studies as of the Execution Date.
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Existing Licensed Product has the meaning set forth in Section 15.5(d).
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Existing Licensed Product means each of the Licensed Products directed towards Licensed Targets having the composition described in Schedule 2.1.10. “Beam FTO Patent Rights” shall mean, subject to Section 2.4.3(c), on an Existing Licensed Product-by-Existing Licensed Product basis, any [**].
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Related to Existing Licensed Product

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • 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.

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • 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.

  • 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.