United States NDA or European Dossier Sample Clauses

United States NDA or European Dossier. Within [*] years after the completion of a positive Phase III Clinical Study, at SALUS’ expense SALUS will use commercially reasonable efforts to: (a) file an NDA with the FDA for the Drug Product in accordance with the Development Plan; or (b) file a European Dossier for the Drug Product in accordance with the Development Plan. At SALUS’ request and expense, PARI will cooperate with SALUS by providing SALUS with the Inhaler Data as reasonably necessary for the NDA or European Dossier or otherwise reasonably desirable by SALUS for its preparation of the NDA or European Dossier. Such cooperation shall be considered Post-Phase II Services or Non-Scientific Services, as the case may be, chargeable to SALUS pursuant to Section 6.0 of this Agreement; however payment for such services shall not count towards any Services fee caps in Section 6.0. SALUS’ possession and use of the Inhaler Data shall be subject to the confidentiality restrictions and other limitations provided in Section 5.5 of this Agreement.
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Related to United States NDA or European Dossier

  • United States If you acquired the software in the United States, Washington state law governs the interpretation of this agreement and applies to claims for breach of it, regardless of conflict of laws principles. The laws of the state where you live govern all other claims, including claims under state consumer protection laws, unfair competition laws, and in tort.

  • United States and Canada For warranty service or information about how to obtain a refund for software acquired in the United States and Canada, contact Microsoft at

  • United States Law The determination of whether Information and Inventions are conceived, discovered, developed or otherwise made by a Party for the purpose of allocating proprietary rights (including Patent, copyright or other intellectual property rights) therein, shall, for purposes of this Agreement, be made in accordance with applicable United States law.

  • UNITED ARAB EMIRATES Notifications

  • European Union The academic use restriction in Section 12.d(i) below does not apply in the jurisdictions listed on this site: (xxx.xx/xxxxxxxxxxx).

  • Alcohol and Drugs Service Provider agrees that the presence of alcohol and drugs are prohibited on the Work Site and while performing their Services. If the Service Provider or any of their agents, employees, or subcontractors are determined to be present or with alcohol or drugs in their possession, this Agreement shall terminate immediately.

  • 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.

  • Outside the United States If you acquired the software in any other country, the laws of that country apply.

  • Alcohol and Drug-Free Workplace City reserves the right to deny access to, or require Contractor to remove from, City facilities personnel of any Contractor or subcontractor who City has reasonable grounds to believe has engaged in alcohol abuse or illegal drug activity which in any way impairs City's ability to maintain safe work facilities or to protect the health and well-being of City employees and the general public. City shall have the right of final approval for the entry or re-entry of any such person previously denied access to, or removed from, City facilities. Illegal drug activity means possessing, furnishing, selling, offering, purchasing, using or being under the influence of illegal drugs or other controlled substances for which the individual lacks a valid prescription. Alcohol abuse means possessing, furnishing, selling, offering, or using alcoholic beverages, or being under the influence of alcohol.

  • 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.

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