Product under Development definition

Product under Development means any product (other than Trial Products):
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Product under Development means a given Product within the Field that is the subject of a Development Program prior to the Transition Effective Date but excludes in reference to any country any indications for which Marketing Approval has been obtained in any such country;
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Examples of Product under Development in a sentence

  • For each Product under Development, prior to the submission of the first BLA to the first Regulatory Authority in the Territory, Green Cross shall submit to the JSC a written summary plan for the Commercialization for each such Product under Development.

  • For illustration purposes only, if Genmab then had one Product under Development, and CureVac and its licensees had five products under research or development and four available product slots (license options), the proportionate amount would be [*****] Genmab shall make such [*****] within [*****] after receipt of an invoice therefor from CureVac.

  • The Parties acknowledge that it is in the Collaboration’s interest that, for each Collaboration Product under Development, the clinical trial materials for Development be made with the same process under the JMC’s oversight.

  • NVS will provide to the JSC, on an annual basis for its review and discussion, a high level report summarizing: (i) any material Development and regulatory activities for each Selected Research Compound and/or Research Product under Development by or on behalf of NVS over the prior Calendar Year; and (ii) any planned future Development and regulatory activities, including those activities it anticipates to initiate or have initiated for the following Calendar Year.

  • SYNTA shall have the right to attend and observe (but not participate actively in) any such material meeting or material conference call with the FDA regarding any Licensed Compound or Licensed Product under Development by ROCHE (or by its Affiliates or Sublicensees).

  • For each Product under Development, prior to the submission of the first BLA to the first Regulatory Authority in the Territory, Zai shall submit to the JCC for review and submission to the JSC for review and approval, a written summary plan for the Commercialization in the Territory for each such Product under Development, as well as updates and amendments thereto.