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.
Sample 1Sample 2Sample 3See All (12)
AutoNDA by SimpleDocs
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.
Sample 1Sample 2Sample 3See All (5)
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.
Sample 1Sample 2Sample 3See All (4)
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 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 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
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
AutoNDA by SimpleDocs
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

Related to Dose Requirements

  • SUBLEASE REQUIREMENTS The following terms and conditions shall apply to any subletting by Tenant of all or any part of the Premises and shall be deemed included in each sublease:

  • Service Requirements Grantee shall:

  • Release Requirement Notwithstanding any provision herein to the contrary, except as otherwise determined by the Company, in order for the Grantee to receive Shares pursuant to the settlement of Vested RSUs under Section 6(a), (b), (c), (d) or (e) above, the Grantee (or the representative of his or her estate) must execute and deliver to the Company a general release and waiver of claims against the Company, its Subsidiaries and their directors, officers, employees, shareholders and other affiliates in a form that is satisfactory to the Company (the “Release”). The Release must become effective and irrevocable under applicable law no later than 60 days following the date of the Grantee’s death, termination of employment or transfer of position, as applicable.

  • Sublicense Requirements Any Sublicense:

  • Service Requirement Except as otherwise provided in Section 6(e) of the Plan or Section 2 of this Agreement, this Option may be exercised only while you continue to provide Service to the Company or any Affiliate, and only if you have continuously provided such Service since the Grant Date of this Option.

  • ERISA Requirements (a) Borrower will not engage in any transaction which would cause an obligation, or action taken or to be taken under this Loan Agreement (or the exercise by Lender of any of its rights under the Note, this Loan Agreement or any of the other Loan Documents) to be a non-exempt prohibited transaction under ERISA or Section 4975 of the Tax Code.

  • Minimum Purchase Requirements Distributor shall make the minimum annual purchase of Products established in Exhibit B, unless the Agreement has become coexclusive. In the period within the fixed term and extension, if applicable, of the Agreement under Section 10(a) subsequent to [ * ], the parties shall meet in San Francisco at least [ * ] prior to the beginning of each of respective year to discuss market conditions and appropriate minimum purchases for such year. In the event that the parties fail to agree on an appropriate minimum any year subsequent to [ * ], the minimum annual purchase requirement for such year shall be calculated increasing or decreasing (as the case may be) the minimum purchase requirement for the preceding year in proportion to the increase or decrease in the [ * ] (based on data from mutually acceptable data provider) of the applicable product in the Territory. In the event Supplier is unable to deliver Products ordered by Distributor in an amount consistent with the most recent forecast, then the minimum annual purchase requirement shall be reduced by the quantity of Products that Supplier is unable to deliver when requested. In the event Distributor fails in any year (a “Shortfall Year”) to make the annual minimum purchase of Agreement Products required by Exhibit B, Supplier shall have the right to give Distributor written notice of default, and if such failure to make the minimum purchase is not cured (through the purchase of an amount of Agreement Product equal to the entire shortfall in the Shortfall Year, which amount shall not be counted towards any minimum purchase requirements for the year of purchase) within [ * ] of receipt of the notice, then Supplier shall have the right, in Supplier’s sole discretion and as Supplier’s sole remedy for Distributor’s failure to meet the minimum purchase requirements hereunder, either to convert the appointment of Distributor from exclusive to non-exclusive or to terminate this Agreement. In the event of either conversion to non-exclusive or termination of this Agreement pursuant to this Section 3(e), the Supplier shall pay Distributor a conversion fee equal to [ * ], and Distributor shall transfer all Regulatory Approvals relating to BMS or DES in the Territory to Supplier.

  • Notice Requirements All notices required or permitted by this Lease shall be in writing and may be delivered in person (by hand or by messenger or courier service) or may be sent by regular, certified or registered mail or U.S. Postal Service Express Mail, with postage prepaid, or by facsimile transmission during normal business hours, and shall be deemed sufficiently given if served in a manner specified in this Paragraph 23. The addresses noted adjacent to a Party's signature on this Lease shall be that Party's address for delivery or mailing of notice purposes. Either Party may by written notice to the other specify a different address for notice purposes, except that upon Lessee's taking possession of the Premises, the Premises shall constitute Lessee's address for the purpose of mailing or delivering notices to Lessee. A copy of all notices required or permitted to be given to Lessor hereunder shall be concurrently transmitted to such party or parties at such addresses as Lessor may from time to time hereafter designate by written notice to Lessee.

  • Performance Requirements 1. Neither Party may impose or enforce any of the following requirements, or enforce any commitment or undertaking, in connection with the establishment, acquisition, expansion, management, conduct or operation of an investment of an investor of a Party or of a non-Party in its territory:

  • Compliance with Requirements Any investment program furnished, and any activities performed, by the Manager or by a Sub-Adviser under this Section shall at all times conform to, and be in accordance with, any requirements imposed by: (1) the Act and any rules or regulations in force thereunder; (2) any other applicable laws, rules and regulations; (3) the Declaration of Trust and By-Laws of the Fund as amended from time to time; (4) any policies and determinations of the Board of Trustees of the Fund; and (5) the fundamental policies of the Fund, as reflected in its Registration Statement under the Act or as amended by the shareholders of the Fund.

Time is Money Join Law Insider Premium to draft better contracts faster.