Milestone Indication definition

Milestone Indication means any Indication as to which a separate Drug Approval Application is required for approval in a jurisdiction. By way of example, (i) for ophthalmology Indications, macular degeneration and diabetic retinopathy are two separate Milestone Indications, (ii) with respect to autoimmune disease indications, Crohn’s disease and ulcerative colitis are two separate Milestone Indications and (iii) with respect to cancer Indications, “Milestone Indication” means a cancer of a particular organ or any metastatic progression thereof, including as distinct Milestone Indications, breast cancer, prostate cancer, colon cancer, rectal cancer, ovarian cancer, uterine cancer, gastric cancer, bladder cancer, brain cancer, bile duct cancer, pancreatic cancer, kidney cancer, stomach cancer, head-and-neck cancer, esophageal cancer, liver cancer, and lung cancer.
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Milestone Indication means a cancer of a particular organ or any metastatic progression thereof, including as distinct Milestone Indications, breast cancer, prostate cancer, colon cancer, rectal cancer, ovarian cancer, uterine cancer, gastric cancer, bladder cancer, brain cancer, bile duct cancer, pancreatic cancer, kidney cancer, stomach cancer, head-and-neck cancer, esophageal cancer, liver cancer, and lung cancer.
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Milestone Indication has the meaning set forth in Section 3.1(d).
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Examples of Milestone Indication in a sentence

  • In connection therewith, Terumo shall enter into a reasonable and customary lock-up agreement which shall provide that Terumo shall not sell any shares of OBIO until at least twelve (12) months after OBIO obtains the PMA from FDA for the Product for the Milestone Indication.

  • For further clarity, if Medarex exercises its Co-Promotion Option with respect to an Additional Product for a Cancer Indication, such Additional Product shall be a Co-Promotion Product only with respect to all Cancer Indications, and not with respect to any Secondary Milestone Indication or [*****] Indication unless and until Medarex exercises its Co-Promotion Option with respect thereto pursuant to the preceding sentence.

  • For further clarity, if Medarex exercises its Co-Promotion Option with respect to the Lead Product for a Cancer Indication, such Product shall be a Co-Promotion Product only with respect to all Cancer Indications, and not with respect to any Secondary Milestone Indication or [*****] Indication unless and until Medarex exercises its Co-Promotion Option with respect thereto pursuant to the preceding sentence.


More Definitions of Milestone Indication

Milestone Indication means, with respect to a Product, any separately defined, well categorized class of human disease, syndrome, disorder or medical condition for which a separate Regulatory Approval is filed for such Product with the applicable Regulatory Authority in a given country. Notwithstanding the foregoing, each of [***]. 1.49 “Net Sales” means the gross price billed or invoiced on sales of a Product by SynBio, its Affiliates, or sublicensees (each if applicable, the “Selling Party”) for sale of such Product to a Third Party in the SynBio Territory, less following deductions actually incurred and borne by the Selling Party and not recovered by or refunded to the Selling Party: [***] Each of the amounts set forth above shall be determined from the books and records of the Selling Party in accordance with the Accounting Standards consistently applied. For the avoidance of doubt, if a single item falls into more than one of the categories set forth in clauses (a)-(g) above, such item may not be deducted more than once. With respect to any sale of a Product in a given country or jurisdiction for less than fair market value or for any substantive consideration other than monetary consideration on arm’s length terms (which has the effect of reducing the invoiced amount below what it would have been in the absence of such non-monetary consideration), for purposes of calculating the Net Sales under this Agreement, such Product shall be deemed to be sold exclusively for cash at the average Net Sales price charged to Third Parties for cash sales in such country or jurisdiction during the applicable reporting period (or if there were only de minimis cash sales in such country or
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Related to Milestone Indication

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • Development Milestone is defined in Section 5.3.

  • Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.

  • Milestone 2 means achievement of annual Net Sales of at least $35,000,000 during any Calendar Year ending on or before December 31, 2024.

  • Milestone Event has the meaning set forth in Section 8.2.1.

  • Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

  • Additional Indication means any indication other than the Initial Indication.

  • Milestone Events has the meaning set forth in Section 7.2.

  • Milestone Payment has the meaning set forth in Section 4.2.

  • Sales Milestone Payment shall have the meaning set forth in Section 8.4.

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

  • Second Indication means [***].

  • Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.

  • Milestones means control points in the project that help to chart progress. Milestones may correspond to the completion of a key deliverable, allowing the next phase of the work to begin. They may also be needed at intermediary points so that, if problems have arisen, corrective measures can be taken. A milestone may be a critical decision point in the project where, for example, the consortium must decide which of several technologies to adopt for further development.

  • Project Milestone means the project milestone set forth in Schedule-J;

  • 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.

  • geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.

  • 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.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Milestone Payments means payments made in connection with any Permitted Acquisition or other acquisition (including any license or the acquisition of any license) of any rights in respect of any drug or other pharmaceutical product (and any related property or assets) to sellers (or licensors) of the assets or Equity Interests acquired (or licensed) therein based on the achievement of specified revenue, profit or other performance targets (financial or otherwise).

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

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.