Existing Licensed Product definition

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 is defined in Section 12.3(d).
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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

  • 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.

  • 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.

  • As of the Execution Date, Licensor is conducting certain Phase IIIA Clinical Studies described in the Development Plan for the Existing Licensed Product for BPH in the Territory.

  • Promptly after the Original Effective Date, the Parties shall discuss in good faith the Manufacture and supply plan for the Licensed Compound and the Existing Licensed Product for Commercialization in the Licensee Territory, which shall take into account the Manufacturing Process transfer as set forth in Section 3.5.2 and as well as timing of approval of additional permitted Manufacturing sites that Licensee may designate.

  • The Parties anticipate that any Licensed Product required for sale by or for CSL in the Territory, beyond the Existing Licensed Product Inventory, shall be manufactured by or on behalf of CSL.

  • In the event that the FDA shall require any Post-Approval Commitment in connection with the Initial Approval of the Existing Licensed Product, the Parties shall mutually agree which Party shall conduct such Post-Approval Commitment.

  • In the event that Licensee elects to Develop any Licensed Product other than the Existing Licensed Product in the Field in the Territory or the Existing Licensed Product for an indication in the Field other than BPH in connection with life cycle management, the JCC shall form a subcommittee to review and approve a strategy throughout the Territory for such Development of and Regulatory Approvals for such Licensed Product in the Field in the Territory.

  • Net Sales in the Royalty Territory of Existing Licensed Products for any additional indication shall [*] Existing Licensed Product for CABG, PABG and AVG for purposes of [*], and worldwide Net Sales of Existing Licensed Products for any additional indication shall be [*] Existing Licensed Product for CABG, PABG and AVG for purposes of [*].

  • Net Sales in the Royalty Territory of Existing Licensed Products for any additional indication shall be added to the sales of the Existing Licensed Product for CABG, PABG and AVG for purposes of calculating the royalty due Corgentech under Section 6.6, and worldwide Net Sales of Existing Licensed Products for any additional indication shall be added to the sales of the Existing Licensed Product for CABG, PABG and AVG for purposes of calculating the milestone payments due under Section 6.3(c).

  • 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.


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 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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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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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 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.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • Licensed Territory means worldwide.

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

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

  • Licensed Field means all fields of use.

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

  • Licensed Fields of Use means the fields of use identified in Appendix B.

  • Competing Product means [***].

  • Licensed Compound means [***].

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Licensed Field of Use means all fields.

  • 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.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • End product means those articles, materials, and supplies to be acquired under the contract for public use.

  • Hemp products means all products made from industrial hemp,