Extension to the European Market Sample Clauses

Extension to the European Market. The 180-day exclusivity is explicit in the US but not in the EU. Nonetheless, in the EU there are other barriers to entry, such as delays in market autho- rization by the medical agencies that create de facto duopoly periods for the first successful generic challenger, making it perhaps similar to the American case. These delays which are sometimes caused by too many applications being filed with the EMA may be strategic and were noted in the Pharmaceutical Sector Inquiry by DG Comp (EC, 2009). The outcomes in that respect should be similar to the ones shown in the main document for the American case. An alternative however is to model the European case as when all the remaining generics enter the market as soon as one generic invalidates the patent. In that case, the European case would mimic the No Exclusivity option modeled above and for which results are shown in the main text.
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Related to Extension to the European Market

  • Notice to European Union Users StatesideBPO, LLC's operations are located primarily in the United States. If you provide information to us, the information will be transferred out of the European Union (EU) and sent to the United States. (The adequacy decision on the EU-US Privacy became operational on August 1, 2016. This framework protects the fundamental rights of anyone in the EU whose personal data is transferred to the United States for commercial purposes. It allows the free transfer of data to companies that are certified in the US under the Privacy Shield.) By providing personal information to us, you are consenting to its storage and use as described in this Policy. Under the regulations of the General Data Protection Regulation ("GDPR") of the EU you have certain rights as a Data Subject. These rights are as follows: · The right to be informed: this means we must inform you of how we intend to use your personal data and we do this through the terms of this Policy. · The right of access: this means you have the right to request access to the data we hold about you and we must respond to those requests within one month. You can do this by sending an email to xxxx@xxxxxxxxxxxx.xxx. · The right to rectification: this means that if you believe some of the date, we hold is incorrect, you have the right to have it corrected. You can do this by logging into your account with us, or by sending us an email with your request. · The right to erasure: this means you can request that the information we hold be deleted, and we will comply unless we have a compelling reason not to, in which case you will be informed of same. You can do this by sending an email to xxxx@xxxxxxxxxxxx.xxx. · The right to restrict processing: this means you can change your communication preferences or opt-out of certain communications. You can do this by sending an email to xxxx@xxxxxxxxxxxx.xxx. · The right of data portability: this means you can obtain and use the data we hold for your own purposes without explanation. If you wish to request a copy of your information, contact us at xxxx@xxxxxxxxxxxx.xxx. · The right to object: this means you can file a formal objection with us regarding our use of your information with regard to third parties, or its processing where our legal basis is our legitimate interest in it. To do this, please send an email to xxxx@xxxxxxxxxxxx.xxx. In addition to the rights above, please rest assured that we will always aim to encrypt and anonymize your personal information whenever possible. We also have protocols in place in the unlikely event that we suffer a data breach and we will contact you if your personal information is ever at risk. For more details regarding our security protections see the section below or visit our website at xxx.xxxxxxxxxxxx.xxx.

  • Xxxxx-Xxxxx Act Xxxxx-Xxxxx Act, as amended (40 U.S.C. 3141-3148). When required by Federal program legislation, all prime construction contracts in excess of $2,000 awarded by non- Federal entities must include a provision for compliance with the Xxxxx-Xxxxx Act (40 U.S.C. 3141- 3144, and 3146-3148) as supplemented by Department of Labor regulations (29 CFR Part 5, “Labor Standards Provisions Applicable to Contracts Covering Federally Financed and Assisted Construction”). In accordance with the statute, contractors must be required to pay wages to laborers and mechanics at a rate not less than the prevailing wages specified in a wage determination made by the Secretary of Labor. In addition, contractors must be required to pay wages not less than once a week. The non-Federal entity must place a copy of the current prevailing wage determination issued by the Department of Labor in each solicitation. The decision to award a contract or subcontract must be conditioned upon the acceptance of the wage determination. The non-Federal entity must report all suspected or reported violations to the Federal awarding agency. The contracts must also include a provision for compliance with the Xxxxxxxx “Anti-Kickback” Act (40 U.S.C. 3145), as supplemented by Department of Labor regulations (29 CFR Part 3, “Contractors and Subcontractors on Public Building or Public Work Financed in Whole or in Part by Loans or Grants from the United States”). The Act provides that each contractor or Subrecipient must be prohibited from inducing, by any means, any person employed in the construction, completion, or repair of public work, to give up any part of the compensation to which he or she is otherwise entitled. The non-Federal entity must report all suspected or reported violations to the Federal awarding agency.

  • Please see the current Washtenaw Community College catalog for up-to-date program requirements Conditions & Requirements

  • Xxxx-Xxxxx-Xxxxxx Act The waiting period (and any extension thereof) applicable to the consummation of the transactions contemplated hereby under the HSR Act shall have expired or been terminated.

  • Sxxxxxxx-Xxxxx Act There is and has been no failure on the part of the Company or any of the Company’s directors or officers, in their capacities as such, to comply with any provision of the Sxxxxxxx-Xxxxx Act of 2002 and the rules and regulations promulgated in connection therewith (the “Sxxxxxxx-Xxxxx Act”), including Section 402 related to loans and Sections 302 and 906 related to certifications.

  • European Monetary Union If, as a result of the implementation of European monetary union, (a) any currency ceases to be lawful currency of the nation issuing the same and is replaced by a European common currency, then any amount payable hereunder by any party hereto in such currency shall instead be payable in the European common currency and the amount so payable shall be determined by translating the amount payable in such currency to such European common currency at the exchange rate recognized by the European Central Bank for the purpose of implementing European monetary union, or (b) any currency and a European common currency are at the same time recognized by the central bank or comparable authority of the nation issuing such currency as lawful currency of such nation, then (i) any Loan made at such time shall be made in such European common currency and (ii) any other amount payable by any party hereto in such currency shall be payable in such currency or in such European common currency (in an amount determined as set forth in clause (a)), at the election of the obligor. Prior to the occurrence of the event or events described in clause (a) or (b) of the preceding sentence, each amount payable hereunder in any currency will continue to be payable only in that currency. The Borrowers agree, at the request of the Required Lenders, at the time of or at any time following the implementation of European monetary union, to enter into an agreement amending this Agreement in such manner as the Required Lenders shall reasonably request in order to avoid any unfair burden or disadvantage resulting from the implementation of such monetary union and to place the parties hereto in the position they would have been in had such monetary union not been implemented, the intent being that neither party will be adversely affected economically as a result of such implementation and that reasonable provisions may be adopted to govern the borrowing, maintenance and repayment of Loans denominated in any Alternative Currency or a European common currency after the occurrence of the event or events described in clause (a) or (b) of the preceding sentence.

  • Xxxxxxxx-Xxxxx Act There is and has been no failure on the part of the Company or any of the Company’s directors or officers, in their capacities as such, to comply with any provision of the Xxxxxxxx-Xxxxx Act of 2002 and the rules and regulations promulgated in connection therewith (the “Xxxxxxxx-Xxxxx Act”), including Section 402 related to loans and Sections 302 and 906 related to certifications.

  • Sxxxxxxx-Xxxxx Compliance As soon as it is legally required to do so, the Company shall take all actions necessary to obtain and thereafter maintain material compliance with each applicable provision of the Sxxxxxxx-Xxxxx Act of 2002 and the rules and regulations promulgated thereunder and related or similar rules and regulations promulgated by any other governmental or self-regulatory entity or agency with jurisdiction over the Company.

  • National Day of Mourning The Company agrees to allow employees one (1) minute silence at 11:00 a.m. on April 28th of each year in observance of those workers killed on the job.

  • CFR PART 200 Procurement of Recovered Materials A non-Federal entity that is a state agency or agency of a political subdivision of a state and its contractors must comply with section 6002 of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act. The requirements of Section 6002 include procuring only items designated in guidelines of the Environmental Protection Agency (EPA) at 40 CFR part 247 that contain the highest percentage of recovered materials practicable, consistent with maintaining a satisfactory level of competition, where the purchase price of the item exceeds $10,000 or the value of the quantity acquired during the preceding fiscal year exceeded $10,000; procuring solid waste management services in a manner that maximizes energy and resource recovery; and establishing an affirmative procurement program for procurement of recovered materials identified in the EPA guidelines. Does vendor certify that it is in compliance with the Solid Waste Disposal Act as described above? Yes

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