Launch at Risk definition

Launch at Risk has the meaning given in Section 7.6(iv)(B).
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Launch at Risk means commercial Marketing of a Generic Product by a Third Party that is (i) prior to the earlier of (a) the Entry Date (as defined below) or (b) a Final Court Decision that such Third Party’s Generic Product does not infringe any valid unexpired claim of the ’218 Patent and the ’222 Patent; and (ii) not licensed or otherwise authorized by the Cadence Parties prior to the date of such Marketing commencement.
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Launch at Risk means the Commercial Marketing of a Generic Product by a Third Party that is (i) prior to the earlier of (a) the License Effective Date (as defined below) or (b) a Final Court Decision that such Third Party’s Generic Product does not infringe any valid unexpired claim of the Licensed Patents; and (ii) is not licensed or otherwise authorized by Xxxxxx prior to the date of such sales. “Licensed Patents” means, [*].“Orange Book” means FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (or any successor or equivalent publication thereof).“Orphan Drug Date” means the date that the Adamas NDA’s orphan drug exclusivity period expires, currently August 24, 2024. “Person” means any individual, firm, corporation, partnership, limited liability company, trust, joint venture, governmental authority, or other entity or organization. “Sandoz ANDA” means ANDA No. 211493 filed by Sandoz Inc. with the FDA [*].
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More Definitions of Launch at Risk

Launch at Risk means a Launch prior to the expiration of all relevant (as determined by the Joint Patent Committee) Patents (or extensions) or revocation of all relevant (as determined by the Joint Patent Committee) Patent applications of a Third Party covering the applicable Product in the Territory, including all Patents listed in any list provided under 351(l)(3)(A) or of the PHS Act with respect to the applicable Product, and [***].
Sample 1
Launch at Risk means the Commercial Marketing of a Generic Product by a Third Party that is (i) prior to the earlier of (a) the License Effective Date (as defined below) or (b) a Final Court Decision that such Third Party’s Generic Product does not infringe any valid unexpired claim of the Licensed Patents; and (ii) is not licensed or otherwise authorized by Adamas prior to the date of such sales.
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Related to Launch at Risk

  • Launch Vehicle means an object, or any part thereof, intended for launch, launched from Earth, or returning to Earth which carries Payloads or persons, or both.

  • At risk means a student who has the potential for academic failure, including, but not

  • Spacecraft (9) means active and passive satellites and space probes.

  • Insured Risks means fire lightning explosion earthquake storm tempest flood subsidence landslip heave impact terrorism bursting or overflowing of water tanks and pipes earthquake damage by aircraft and other aerial devices or articles dropped there from riot and civil commotion labour disturbance and malicious damage and such other risks as the Academy Trust insures against from time to time subject in all cases to any exclusions or limitations as may from time to time be imposed by the insurers or underwriters;

  • Country Risk means all factors reasonably related to the systemic risk of holding Foreign Assets in a particular country including, but not limited to, such country’s political environment, economic and financial infrastructure (including any Eligible Securities Depository operating in the country), prevailing or developing custody and settlement practices, and laws and regulations applicable to the safekeeping and recovery of Foreign Assets held in custody in that country.

  • Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

  • Sustainability Risk means an environmental, social or governance event or condition that, if it occurs, could cause an actual or a potential material negative impact on the value of the investment;

  • Low risk means normal, uncomplicated prenatal course as determined by adequate prenatal care and prospects for a normal, uncomplicated birth as defined by reasonable and generally accepted criteria of maternal and fetal health.

  • market risk means the risk of loss for the individual portfolio resulting from a fluctuation in the market value of positions in the portfolio attributable to changes in market variables, such as interest rates, foreign exchange rates, equity and commodity prices, or an issuer's creditworthiness;

  • Payload means all property to be flown or used on or in a Launch Vehicle.

  • Switched Access Detail Usage Data means a category 1101xx record as defined in the EMI Telecordia Practice BR 000-000-000.

  • operational risk means the risk of loss resulting from inadequate or failed internal processes, people and systems or from external events, and includes legal risk;

  • Excused Downtime means the number of minutes in the Charging Period that the LSP is unavailable due to:

  • Sound level meter means an instrument which includes a microphone, amplifier, RMS detector, integrator or time averager, output meter, and weighting networks used to measure sound pressure levels.

  • Transponder means an access device used to gain entry to the parking facility;

  • Scheduled Downtime has the meaning set forth in Section 5.2.

  • Satellite Manufacturer means, with respect to any Satellite, the prime contractor and manufacturer of such Satellite.

  • fall risk means any potential exposure to falling either from, off or into;

  • ro-ro passenger ship means a passenger ship with ro-ro spaces or special category spaces as defined in regulation II-2/3.

  • Launch means the intentional ignition of the first-stage motor(s) of the Launch Vehicle intended to place or try to place a Launch Vehicle (which may or may not include any Transfer Vehicle, Payload or crew) from Earth:

  • high risk breach means that the threshold for notifying the individual is higher than that for notifying the relevant supervisory authority.

  • Second Level Domain means that portion of a domain name to the left of the right-most period, up to the second period from the right, if any, plus the Top Level Domain. (In the example, “XXXXXXXXX.XXX”.) “Third Level Domain” means that portion of a domain name to the left of the second period from the right, if any, up to the third period from the right, if any, plus the Second Level Domain. (In the example, “XXXXXXXXX.XXXXXXXXX.XXX”.).

  • Planned Downtime means planned downtime for upgrades and maintenance to the Services scheduled in advance of such upgrades and maintenance.

  • systemic risk means a risk of disruption in the financial system with the potential to have serious negative consequences for the financial system and the real economy;

  • Network Upgrades means modifications or additions to transmission-related facilities that are integrated with and support the Transmission Provider’s overall Transmission System for the general benefit of all users of such Transmission System. Network Upgrades shall include:

  • Country Risks means with respect to any Foreign Depository: (a) the financial infrastructure of the country in which it is organized, (b) such country's prevailing custody and settlement practices, (c) nationalization, expropriation or other governmental actions, (d) such country's regulation of the banking or securities industry, (e) currency controls, restrictions, devaluations or fluctuations, and (f) market conditions which affect the order execution of securities transactions or affect the value of securities.