Dose Requirements Sample Clauses

Dose Requirements. All TDF Product and TDF Combination Product manufactured, used or sold by Licensee shall consist of a single dose concentration of 300 milligrams of TDF per dose. All TAF Product, TAF Combination Product, EVG Product, COBI Product, EVG Combination Product, COBI Combination Product, and Quad Product manufactured, used or sold by Licensee shall consist of dose concentrations of TAF, EVG and/or COBI that have been approved by the FDA. Licensee agrees that it shall not manufacture or sell Products (including Combination Products) with any API formulated at a single dose concentration other than a dose concentration approved by the FDA (each an “Alternate Dosage”), without prior written consent from Gilead, provided, however, that in the case of TDF, TAF and COBI, Licensee may manufacture or sell TDF Product, TDF Combination Product, TAF Product, TAF Combination Product, COBI Product, or COBI Combination Product consisting of an Alternate Dosage if such Alternate Dosage has been approved for use in the Field by the appropriate regulatory authority having jurisdiction over such Product. By means of example, dosage concentrations of TDF lower than 300 milligrams in tablet form will be allowed for pediatric administrations only if such lower dosage has been approved by the FDA or the appropriate foreign regulatory authority for such administration.
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Dose Requirements. All BIC Product and BIC Combination Products manufactured, used or sold by Licensee shall consist of dose concentrations of BIC that have been approved by the FDA. In the case of Products containing BIC, Licensee may manufacture or sell BIC Product, or BIC Combination Product consisting of an Alternate Dosage if such Alternate Dosage has been approved for use in the Field by the appropriate regulatory authority having jurisdiction over such Product.
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Dose Requirements. All Product used or sold by Licensee shall consist of a single dose concentrations of Sof and LDV that are the same as the dose concentration for such agent that has been approved by (i) the FDA or (ii) by (y) DCGI and (z) the appropriate regulatory authority having jurisdiction over such Product in the country of sale. Licensee agrees that it shall manufacture or sell Products only as approved by the FDA for the Field or as approved for use in the Field by the appropriate regulatory authority having jurisdiction over such Product in the country of sale.
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Dose Requirements. All Product manufactured, used or sold by Licensee shall consist of a single dose concentration of 300 milligrams of TDF per dose. Licensee agrees that it shall not manufacture or sell Products formulated at a single dose concentration other than 300 milligrams of TDF per dose (each an “Alternate Dosage”), provided, however, that Licensee may manufacture or sell Products consisting of an Alternate Dosage if such Alternate Dosage has been approved for use in the Field by the appropriate regulatory authority having jurisdiction over such Product. By means of example, dosage concentrations of TDF lower than 300 milligrams will be allowed for pediatric administrations only if such lower dosage has been approved by the FDA or the appropriate foreign regulatory authority for such administration.
Sample 1
Dose Requirements. All TAF Product, TAF Combination Product, EVG Product, COBI Product, EVG Combination Product, COBI Combination Product, BIC Product, BIC Combination Product, and TAF Quad manufactured, used or sold by Licensee shall consist of single dose concentrations of TAF, EVG, COBI, and/or BIC, that are the same as the dose concentration for such agent that has been approved by the FDA. Licensee agrees that it shall not manufacture or sell Products (including Combination Products) formulated at a single dose concentration other than those dose concentrations [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. approved by the FDA for such agents (each an “Alternate Dosage”), without prior written consent from Gilead, provided, however, that in the case of TAF, COBI, and BIC, Licensee may manufacture or sell TAF Product, TAF Combination Product, COBI Product, COBI Combination Product, BIC Product, or BIC Combination Product consisting of an Alternate Dosage if such Alternate Dosage has been approved for use in the Field by the appropriate regulatory authority having jurisdiction over such Product.
Sample 1
Dose Requirements. All Product used or sold by Licensee shall consist of a single dose concentrations of NTX and MXXX that are the same as the dose concentration for such agent that has been approved by (i) the FDA or (ii) by (y) DCGI and (z) the appropriate regulatory authority having jurisdiction over such Product in the country of sale. Licensee agrees that it shall manufacture or sell Products only as approved by the FDA for the Field or as approved for use in the Field by the appropriate regulatory authority having jurisdiction over such Product in the country of sale.
Sample 1
Dose Requirements. All Product used or sold by Licensee shall consist of single dose concentrations of RDV that are the same as the dose concentration for RDV that has been approved by the FDA for Gilead RDV Product. Licensee agrees that it shall manufacture and/or sell Product only as approved by the FDA for the Field and as approved for use in the Field by the appropriate regulatory authority having jurisdiction over Product in the country of sale.
Sample 1
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Dose Requirements. All TAF Product, TAF Combination Product, EVG Product, COBI Product, EVG Combination Product, COBI Combination Product, BIC Product, BIC Combination Product, and TAF Quad manufactured, used or sold by Licensee shall consist of single dose concentrations of TAF, EVG, COBI, and/or BIC, that are the same as the dose concentration for such agent that has been approved by the FDA. Licensee agrees that it shall not manufacture or sell Products (including Combination Products) formulated at a single dose concentration other than those dose concentrations approved by the FDA for such agents (each an “Alternate Dosage”), without prior written consent from Gilead, provided, however, that in the case of TAF, COBI, and BIC, Licensee may manufacture or sell TAF Product, TAF Combination Product, COBI Product, COBI Combination Product, BIC Product, or BIC Combination Product consisting of an Alternate Dosage if such Alternate Dosage has been approved for use in the Field by the appropriate regulatory authority having jurisdiction over such Product.
Sample 1

Related to Dose Requirements

  • License Requirements The Hotel’s alcoholic beverage license requires that the Hotel shall: (i) request proper identification (photo ID) of any person of questionable age and refuse alcoholic beverage service if the person is either under age or proper identification cannot be produced, and (ii) refuse alcoholic beverage service to any person who, in the Hotel’s judgment, appears to be intoxicated; and (iii) instruct its personnel to avoid encouraging patrons to consume alcoholic beverages (commonly referred to as “over-pouring”).

  • Time Requirements The Independent Contractor will not be required to follow or establish a regular or daily work schedule, but shall devote during the term of this Agreement the time, energy and skill as necessary to perform the services of this engagement and shall, periodically or at any time upon the request of the Company, submit information as to the amount of time worked and scope of work performed.

  • Testing Requirements 12.1. Workplaces -

  • Specific Requirements 7.4.1 Workers’ compensation insurance with statutory limits required by South Dakota law. Coverage B-Employer’s Liability coverage of not less than $500,000 each accident, $500,000 disease-policy limit, and $500,000 disease-each employee.

  • Check Requirements Any image of a check that I transmit to you must accurately and legibly provide all the information on the front and back of the check at the time presented to me by the drawer. Prior to capturing the original check, I will indorse the back of the original check. My endorsement will include "For Directions E- Deposit Only" in addition to my signature. The image of the check transmitted to you must accurately and legibly provide, among other things, the following information: (1) the information identifying the drawer and the paying bank that is preprinted on the check, including complete and accurate MICR information and the signature(s); and (2) other information placed on the check prior to the time an image of the check is captured, such as any required identification written on the front of the check and any endorsements applied to the back of the check. The image quality for the check will meet the standards for image quality established by the American National Standards Institute ("ANSI"), the Board of Governors of the Federal Reserve, and any other regulatory agency, clearing house or association. Rejection of Deposit. You are not liable for any service or late charges levied against me due to your rejection of any item. In all cases, I am responsible for any loss or overdraft plus any applicable fees to my Account due to an item being returned. Items Returned Unpaid. A written notice will be sent to me of transactions you are unable to process because of returned items. With respect to any item that I transmit to you for remote deposit that you credit to my Account, in the event such item is dishonored, I authorize you to debit the amount of such item from the Account. Email Address. I agree to notify you immediately if I change my email address, as this is the email address where you will send me notification of receipt of remote deposit items.

  • 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.

  • System Requirements Apple Software is supported only on Apple-branded hardware that meets specified system requirements as indicated by Apple.

  • Interface Requirements 9.3.1 BellSouth shall offer LIDB in accordance with the requirements of this subsection.

  • 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.

  • Age Requirement The employee must have reached the age of fifty-five (55) before reduction in workload.

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