General Analytic Considerations Sample Clauses

General Analytic Considerations. The full analysis dataset will include all patients randomized to either levosimendan or placebo. All analyses will be based on the intent-to-treat (ITT) principle using the full analysis dataset and SAS version 9 or higher software. The full details of the analysis will be described in a statistical analysis plan.
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Related to General Analytic Considerations

  • General Background Ecuador is part of the United Nations Convention of 1951 relating to the Status of Refugees and its 1967 Protocol, as well as major international and regional human rights instruments that recognize the right to asylum. It is also part of the United Nations Convention of 1954 relating to the Status of Stateless Persons and the United Nations Convention of 1961 on the Reduction of Statelessness. The asylum procedure in Ecuador is regulated by the Organic Law of Human Mobility, effective February 6, 2017. Ecuador is a country of transit and destination for people who need international protection. In the last two decades, Ecuador hosted more than 68,708 recognized refugees (mainly Colombian) and has become one of the leading countries of transit and destination for Venezuelan refugees and migrants. Ecuador receives the third highest number of Venezuelans after Colombia and Peru. Since 2016, more than 4.7 million Venezuelans have left their country, making it the biggest exodus in the history of Latin America. Of these, 2.2 million have entered Ecuador, of which estimated 500,000 have been established in the country according to the R4V. In 2019, approximately 2,100 Venezuelans per day entered Ecuador (with peaks of 6,000) until 26 August, when Ecuador began requiring visas for Venezuelans. Since 2018, the number of Venezuelan asylum seekers exceeded the number of asylum seekers from Colombia. The Office of the United Nations High Commissioner for Refugees works in Ecuador supporting the Ecuadorian government to protect refugees and looking for durable solutions. UNHCR's operation in Ecuador began in 2000 as part of the strategy of the organization to protect and provide assistance, particularly to the victims of the Colombian conflict. The Ecuadorian 2023-2025 Multiyear Strategy aims to support the Government of Ecuador to: (i) the development of protection mechanisms, (ii) strengthening national asylum system, (iii) and identification of durable solutions, including alternative pathways. The operation is coordinated at the national level by the country office in Quito. In addition, UNHCR has Sub- Offices in Quito (Solanda), Xxxxxx and Guayaquil; Field Offices in Esmeraldas, Huaquillas, Tulcán, Lago Agrio, and Field Units in Manta, Cuenca and Ambato.

  • Check and complete if Transferee will take delivery of a beneficial interest in the IAI Global Note or a Restricted Definitive Note pursuant to any provision of the Securities Act other than Rule 144A or Regulation S. The Transfer is being effected in compliance with the transfer restrictions applicable to beneficial interests in Restricted Global Notes and Restricted Definitive Notes and pursuant to and in accordance with the Securities Act and any applicable blue sky securities laws of any state of the United States, and accordingly the Transferor hereby further certifies that (check one):

  • Background and Narrative of Budget Reductions 2. Assumptions Used in the Deficit Reduction Plan: - EBF and Estimated New Tier Funding: - Equal Assessed Valuation and Tax Rates: - Employee Salaries and Benefits: - Short and Long Term Borrowing: - Educational Impact: - Other Assumptions: - Has the district considered shared services or outsourcing (Ex: Transportation, Insurance) If yes please explain: ESTIMATED LIMITATION OF ADMINISTRATIVE COSTS (School Districts Only) (For Local Use Only)

  • Milestones Subject to the provisions of the SGIP, the Parties shall agree on milestones for which each Party is responsible and list them in Attachment 4 of this Agreement. A Party’s obligations under this provision may be extended by agreement. If a Party anticipates that it will be unable to meet a milestone for any reason other than a Force Majeure event, it shall immediately notify the other Parties of the reason(s) for not meeting the milestone and (1) propose the earliest reasonable alternate date by which it can attain this and future milestones, and (2) requesting appropriate amendments to Attachment 4. The Party affected by the failure to meet a milestone shall not unreasonably withhold agreement to such an amendment unless it will suffer significant uncompensated economic or operational harm from the delay, (1) attainment of the same milestone has previously been delayed, or (2) it has reason to believe that the delay in meeting the milestone is intentional or unwarranted notwithstanding the circumstances explained by the Party proposing the amendment.

  • Paid Claims without Supporting Documentation Any Paid Claim for which Xxxxxxx cannot produce documentation shall be considered an error and the total reimbursement received by Xxxxxxx for such Paid Claim shall be deemed an Overpayment. Replacement sampling for Paid Claims with missing documentation is not permitted.

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK Firms and/or individuals that assisted in the development or drafting of the specifications, requirements, statements of work, or solicitation documents contained herein are excluded from competing for this solicitation. This shall not be applicable to firms and/or individuals providing responses to a publicly posted Request for Information (RFI) associated with a solicitation.

  • Milestone Payments From and after the Closing Date but prior to the expiration of the Put Option Period (the “Post-Closing Milestone Period”), in addition to the consideration set forth in Section 1.6(c) above, in the event that (x) the Acquired Company has achieved the Base Milestones and the Sellers’ Representative has delivered a Milestone Completion Notice, but the Acquired Company has not achieved an Additional Milestone on the Closing Date, and (y) the Acquired Company achieves the Additional Milestone during the Post-Closing Milestone Period, Purchaser shall pay to Sellers the additional amount payable in respect of such Additional Milestone in cash or, at Purchaser’s sole election, in shares of Purchaser Common *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission. Stock, as set forth in Section 1.6(b)(iii) (each, a “Milestone Payment,” and collectively, the “Milestone Payments”). The Milestone Payments and the Initial Purchase Price shall be referred to herein together as the “Aggregate Purchase Price.” Upon achieving an Additional Milestone, Purchaser shall promptly provide written notice to Sellers’ Representative specifying the Additional Milestone achieved, and Purchaser shall pay the applicable Milestone Payment to Sellers within ten (10) Business Days thereof to the bank accounts or brokerage accounts indicated by the Sellers in accordance with the Proceeds Allocation, subject in each case, to the dispute resolution procedures set forth in Section 1.11. In the event of a Change of Control of Purchaser, Purchaser agrees to either (a) cause the acquirer to assume, whether in writing or by operation of law, all remaining Milestone Payments subject to the terms and conditions set forth herein or (b) accelerate the remaining Milestone Payments such that the Milestone Payments become payable immediately prior to the closing of the Change of Control transaction.

  • PROGRESS AND ROYALTY REPORTS 8.1 For the period beginning [date] LICENSEE will submit to REGENTS a semi-annual progress report covering LICENSEE's activities related to the development and testing of all LICENSED PRODUCTS, LICENSED SERVICES and LICENSED METHOD and the obtaining of necessary governmental approvals, if any, for marketing in the United States. These progress reports will be made for all development activities until the first SALE occurs in the United States.

  • Reporting Obligations and Regulatory Approvals Applicable laws and regulations may require holders and beneficial owners of Shares, including the Holders and Beneficial Owners of ADSs, to satisfy reporting requirements and obtain regulatory approvals in certain circumstances. Holders and Beneficial Owners of ADSs are solely responsible for determining and complying with such reporting requirements and obtaining such approvals. Each Holder and each Beneficial Owner hereby agrees to make such determination, file such reports, and obtain such approvals to the extent and in the form required by applicable laws and regulations as in effect from time to time. Neither the Depositary, the Custodian, the Company or any of their respective agents or affiliates shall be required to take any actions whatsoever on behalf of Holders or Beneficial Owners to determine or satisfy such reporting requirements or obtain such regulatory approvals under applicable laws and regulations.

  • Development Milestone Payments In partial consideration for the rights and licenses granted to Coya hereunder, within ten days after the first achievement of each milestone event in a given Indication set forth in this Section 5.2 (Development Milestone Payments) with respect to a Product (each, a “Development Milestone Event”) by or on behalf of Coya or any of its Affiliates or Sublicensees, Coya shall provide ARScience Bio written notice to ARScience Bio identifying the Development Milestone Event achieved. Upon receipt of any such notice of first achievement of a Development Milestone Event by Coya or its Affiliates or Sublicensees, ARScience Bio will promptly invoice Coya for the applicable Development Milestone Event and Coya will make a milestone payment to ARScience Bio in the amount set forth in this Section 5.2 (Development Milestone Payments) corresponding to such Development Milestone Event (each, a “Development Milestone Payment”) within 45 days of receipt of such invoice. On an Indication-by-Indication basis, each Development Milestone Payment shall be payable only upon the first achievement of the corresponding Development Milestone Event by a Product, in any given Indication for which the Development Milestone Events have not been previously achieved (each such Indication, a “New Indication”). No amounts shall be due for subsequent or repeated achievements of such Development Milestone Event with respect to the same or different Mono Product or Combination Product, as applicable, in such Indication. Accordingly and for clarity, the Development Milestone Payment shall be paid only once, when first achieved by Coya, an Affiliate or a Sublicensee, but no payment shall be due if the same milestone is subsequently achieved by one of Coya, an Affiliate or a Sublicensee. For clarity, the amounts owed in Column (a) below shall be due for the first Combination Product to achieve the Development Milestone Events in a New Indication and the amounts owned in Column (c) below shall be due for the first Mono Product to achieve the Development Milestone Events in a New Indication. Any Combination Product or Mono Product to achieve the Development Milestone Events in a New Indication after the first achievement of the Development Milestone Events as described in the foregoing sentence will cause the amounts in Column (b) with respect to a Combination Product and Column (d) with respect to a Mono Product to be due and payable by Coya upon each such occurrence. If the first Product to achieve a Development Milestone Event in any Indication is a Combination Product, the amounts in Column (a) below shall be due and payable by Coya. If the next Product to achieve a Development Milestone Event in a New Indication is a Mono Product, the amounts in Column (c) below would be due and payable by Coya; provided, that if such next Product to achieve a Development Milestone Event in a New Indication is a Combination Product, the amounts in Column (b) would be due and payable by Coya. By way of example, if a Combination Product achieves IND Acceptance in ALS, and is the first Product to achieve a Development Milestone Event under this Agreement, [***] will be due and payable by Coya. If subsequently a Mono Product achieves IND Acceptance in ALS, no Development Milestone Payments will be due and payable by Coya under this Agreement. However, if subsequently any Combination Product achieves IND Acceptance in Alzheimer’s disease, [***] would be due and payable by Coya.

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