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 (b) a Final Court Decision that such Third Party’s Generic Product does not infringe any valid claim of the ’218 Patent and the ’222 Patent; and (ii) not licensed or otherwise authorized by Cadence prior to the date of such Marketing commencement.
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.
Sample 1

More Definitions of Launch at Risk

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 [*].
Sample 1
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 [***].
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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 there is reason to believe injury, hazard, damage, or loss may occur.

  • Spacecraft (7 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;

  • Smart Meter means a meter which tells us how much Energy you are using without us having to visit your home and which enables you to see how much Energy you are using;

  • 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 iconectiv Practice BR 010-200-010.

  • operational risk means the risk of loss for the individual portfolio resulting from inadequate internal processes and failures in relation to people and systems of the investment service provider or from external events, and includes legal and documentation risk and risk resulting from the trading, settlement and valuation procedures operated on behalf of the individual portfolio;

  • Excused Downtime means the number of minutes in the Charging Period, rounded to the nearest minute that the link state of Customer’s Port is ‘down’ 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.

  • Supply chain risk means the risk that an adversary may sabotage, maliciously introduce unwanted function, or otherwise subvert the design, integrity, manufacturing, production, distribution, installation, operation, or maintenance of a covered system so as to surveil, deny, disrupt, or otherwise degrade the function, use, or operation of such system (see 10 U.S.C. 2339a).

  • 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 any period of time during which the Service is unavailable due to Conga’s planned maintenance and support of the Service or Conga System. Planned Downtime shall not exceed 5 hours per month. Conga will endeavor to give at least 24 hours’ notice before Planned Downtime except for urgent circumstances (e.g., a system failure or security threat). Planned Downtime occurs from 10:00 p.m. Friday through 1:00 p.m. Sunday, Mountain Time.

  • Licensed Level means a) when referenced in the context of a Named User, the quantity of Metric for which each individual Named User category and type is licensed -and- b) when referenced in the context of a Package, the quantity of Metric for which each individual Package is licensed; and