U.S. IND Requirements Sample Clauses

U.S. IND Requirements. Because the Multi- Centre Study is being conducted under a U.S. IND, Provider and Investigator agree to provide such information and documents as Sponsor may reasonably require for Sponsor to comply with the requirements of the U.S. Food and Drug Administration (“FDA”), including required financial disclosures (which shall be updated as necessary through the period ending one (1) year after the conclusion of the Trial) and a Statement of Investigator (Form FDA 1572) (or equivalent information and certifications).
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U.S. IND Requirements. Because the Multi- Centre Study is being conducted under a U.S. IND, Institution and Investigator agree to provide such information and documents as Sponsor may reasonably require for Sponsor to comply with the requirements of the U.S. Food and Drug Administration (“FDA”). Information will be provided via forms that the Sponsor is obliged to provide.. přípravků, ve znění pozdějších předpisů, zákona č. 89/2012 Sb., občanský zákoník, ve znění pozdějších předpisů a protože se multicentrická studie provádí na základě IND podané ve Spojených státech, jakýchkoliv jiných příslušných zákonů a předpisů, o nichž (jakož i z nich vyplývajících povinností) zadavatel písemně informoval zdravotnické zařízení. „Platné zákony“ zahrnují také všechny výše uvedené ve vztahu k etickému obchodnímu chování (včetně protikorupčních zákonů), nařízení 2016/679 o ochraně fyzických osob v souvislosti se zpracováním osobních údajů a o volném pohybu těchto údajů a o zrušení směrnice 95/46/ES („GDPR“), zákon č. 101/2000 Sb., o ochraně osobních údajů, a zahrnují rovněž požadavky a podmínky schválení příslušné nezávislé etické komise (níže vymezené) a zásady a postupy zdravotnického zařízení. Jelikož výše uvedené “Platné zákony” mohou být do budoucna změněny či nahrazeny, zahrnují “Platné zákony” také tyto budoucí právní předpisy. Všechny smluvní strany jsou povinny řídit se Platnými zákony.

Related to U.S. IND Requirements

  • Export Requirements The Program, Documentation and all related technical information or materials are subject to export controls and U.S. Government export regulations. You will comply strictly with all legal requirements established under these controls and will not, in connection with its limited evaluation rights hereunder, export, re-export, divert, transfer or disclose, directly or indirectly the Program, Documentation and any related technical information or materials without the prior approval of the U.S.

  • TITLE VI REQUIREMENTS H-GAC in accordance with the provisions of Title VI of the Civil Rights Act of 1964 (78 Xxxx. 000, 00 X.X.X. §§ 0000x to 2000d-4) and the Regulations, hereby notifies all bidders that it will affirmatively ensure that any disadvantaged business enterprises will be afforded full and fair opportunity to submit in response to this Agreement and will not be discriminated against on the grounds of race, color, or national origin in consideration for an award.

  • Limits and Requirements A. Workers’ Compensation/Employer’s Liability Insurance The minimum limits of insurance are: Part One: Statutory Part Two: Each Accident $1,000,000 Disease – Policy Limit $1,000,000 Disease – Each Employee $1,000,000

  • Basic Requirements To be eligible for PayPal’s Seller Protection program, all of the following basic requirements must be met, as well as any applicable additional requirements: • The primary address for your PayPal account must be in the United States. • The item must be a physical, tangible good that can be shipped, except for items subject to the Intangible Goods Additional Requirements. Transactions involving items that you deliver in person in connection with payment made in your physical store, may also be eligible for PayPal’s Seller Protection program so long as the buyer paid for the transaction in person by using a PayPal goods and services QR code. • You must ship the item to the shipping address on the Transaction Details page in your PayPal account for the transaction. If you originally ship the item to the recipient’s shipping address on the Transaction Details page but the item is later redirected to a different address, you will not be eligible for PayPal’s Seller Protection program. We therefore recommend not using a shipping service that is arranged by the buyer, so that you will be able to provide valid proof of shipping and delivery. • The shipping requirement does not apply to eligible transactions involving items that you deliver in person; provided, however, that you agree to provide us with alternative evidence of delivery or such additional documentation or information relating to the transaction that we may request. • You must respond to PayPal’s requests for documentation and other information in a timely manner as requested in our email correspondence with you or in our correspondence with you through the Resolution Center. If you do not respond to PayPal’s request for documentation and other information in the time requested, you may not be eligible for PayPal’s Seller Protection program. • If the sale involves pre-ordered or made-to-order goods, you must ship within the timeframe you specified in the listing. Otherwise, it is recommended that you ship all items within 7 days after receipt of payment. • You provide us with valid proof of shipment or delivery. • The payment must be marked “eligible” or “partially eligible” in the case of Unauthorized Transaction claims, or “eligible” in the case of Item Not Received claims, for PayPal’s Seller Protection program on the Transaction Details page. • In the case of an Unauthorized Transaction claim, you must provide valid proof of shipment or proof of delivery that demonstrates that the item was shipped or provided to the buyer no later than two days after PayPal notified you of the dispute or reversal. For example, if PayPal notifies you of an Unauthorized Transaction claim on September 1, the valid proof of shipment must indicate that the item was shipped to the buyer no later than September 3 to be eligible for PayPal’s Seller Protection program. PayPal determines, in its sole discretion, whether your claim is eligible for PayPal’s Seller Protection program. PayPal will make a decision, in its sole discretion, based on the eligibility requirements, any information or documentation provided during the resolution process, or any other information PayPal deems relevant and appropriate under the circumstances. Item Not Received additional requirements To be eligible for PayPal’s Seller Protection program for a buyer’s Item Not Received claim, you must meet both the basic requirements and the additional requirements listed below: • Where a buyer files a chargeback with the issuer for a card-funded transaction, the payment must be marked “eligible” for PayPal’s Seller Protection on the Transaction Details page. • You must provide proof of delivery as described below.

  • HIPAA Requirements The Parties agree that the provisions under HIPAA Rules that are required by law to be incorporated into this Amendment are hereby incorporated into this Agreement.

  • Report Requirements The Company will send to the Reinsurer the following reports electronically, by the times indicated below:

  • Bond Requirements The Contractor hereby agrees to comply with the State’s bonding requirements as identified in the Instructions to Bidders which are included in the RFP and are attached and incorporated into the Contract Documents.

  • Staff Requirements Contractor shall employ, at a minimum, the following:

  • W-9 Requirement Alongside a signed copy of this Agreement, Grantee will provide Florida Housing with a properly completed Internal Revenue Service (“IRS”) Form W-9. The purpose of the W-9 form is to document the SS# or FEIN# per the IRS. Note: W-9s submitted for any other entity name other than the Grantee’s will not be accepted.

  • Local Law Requirements Spain. With respect to Customers domiciled in Spain, in the event of any conflict between any statutory law in Spain applicable to Customer, and the terms and conditions of this Agreement, the applicable statutory law shall prevail.

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