Legal Clearance definition
Examples of Legal Clearance in a sentence
Upon deciding to proceed with Pre Final Legal Clearance Launch, Sandoz shall promptly notify Momenta of such decision and shall use Commercially Reasonable Efforts to Commercialize the Product.
For example, if Final Legal Clearance occurs midway between the [**] and [**] anniversary of U.S. Launch, the first two (2) Commercial Milestone Payments shall be due 45 days after the end of the Post-Launch Quarter in which Final Legal Clearance occurs.
For the avoidance of doubt, if Final Legal Clearance does not occur during the Term, no Commercial Milestone Payment(s) shall be due to Momenta.
Sandoz and Momenta, and, to the extent appropriate, BCWI, shall jointly collaborate in the Development and Commercialization of the Product and the Legal Activities, using Commercially Reasonable Efforts to Develop the Product, to achieve Legal Clearance, to bring the Product to the market in the U.S. Territory within a commercially reasonable time period (subject to the provisions of Section 6.2.1) and to Commercialize the Product in the U.S. Territory.
Prior to the Product obtaining Final Legal Clearance in any country, Mylan may[***] Launch such Product in such country without obtaining Momenta’s prior consent solely by following the process described in subsections (ii) — (v) of this Section 2.4(f).
Each Commercial Milestone Payment shall be made within forty-five (45) days after the end of the applicable Post-Launch Quarter in which the Milestone Event referenced in the above table occurs; PROVIDED, HOWEVER, that if any Milestone Event occurs prior to Final Legal Clearance, the applicable Commercial Milestone Payment for such Milestone Event shall be made within forty-five (45) days after the end of the Post-Launch Quarter in which Final Legal Clearance occurs.
Sandoz shall have sole responsibility to make decisions with respect to Legal Clearance (except with respect to the determination of whether Legal Clearance has occurred, which shall be determined in accordance with the definitions herein of Final ROW Legal Clearance and Final U.S. Legal Clearance, as applicable); provided, that such decisions are generally consistent with the strategy set therefor by the JOC.
Except with respect to its decision to proceed with Pre Final Legal Clearance Launch with respect to a Product in a country, which may be made in Sandoz’s sole discretion, Sandoz shall exercise its final decision-making authority in good faith and in a Commercially Reasonable manner.
Legal Expenses that are Legal Clearance Costs shall be incurred by the Parties according to the relevant Annual Collaboration Plan.
Sandoz shall have sole responsibility to make decisions with respect to Legal Clearance (except with respect to the determination of whether Legal Clearance has occurred, which shall be determined in accordance with the definitions herein of District Court Legal Clearance and Final Legal Clearance); PROVIDED THAT such decisions are generally consistent with the strategy set therefor by the JSC, and subject to the provisions of Section 13.2.