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.
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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 Adamas prior to the date of such sales.
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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 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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Related to Launch at Risk

  • At risk means there is reason to believe injury, hazard, damage, or loss may occur.

  • 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;

  • 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.

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

  • 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;

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

  • Second Level Domain “Second Level Domain” has the meaning given to it in this paragraph. “URL” means a web address, including the “http://” and any material appearing after a slash in the address. “Domain Name” means a URL, less the “http://” and any material appearing to the right of the next slash (‘/’) in the address. (So for example, in the URL “Xxxx://xxxxxxxxx.xxxxxxxxx.xxx/homepage.html”, the Domain Name is “XXXXXXXXX.XXXXXXXXX.XXX”.) “Top Level Domain” means the portion of the Domain Name to the right of the right-most period. (In the example, “COM”.) “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.

  • 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

  • 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.

  • Insured Loss means damage or destruction to the Premises, other than Lessee-Owned Alterations and Utility Installations and Trade Fixtures, which was caused by an event required to be covered by the insurance described in Paragraph 8.3(a) irrespective of any deductible amounts or coverage limits involved.

  • Check Meter means the Buyer revenue-quality meter section or meter(s), which Buyer may require at its discretion, as set forth in Section 3.08(b) and will include those devices normally supplied by Buyer or Seller under the applicable utility Electric Service Requirements.

  • Risk Period means the period that the Landlord [in its absolute discretion]21 decides, being a minimum of [three] years and a maximum of [five]22 years, starting on the date of the relevant damage or destruction;

  • Yearly (1/Year) sampling frequency means the sampling shall be done in the month of September, unless specifically identified otherwise in the effluent limitations and monitoring requirements table.

  • Loss Absorbing Instrument means, at any time, any Additional Tier 1 Capital instrument (other than the Notes) issued directly or indirectly by the Issuer which contains provisions pursuant to which all or part of its principal amount may be written-down (whether on a permanent or temporary basis) or may otherwise absorb losses (in each case in accordance with its terms) on the occurrence, or as a result, of a trigger event set by reference to the Group CET1 Ratio;