Dose Requirements Clause Samples
The Dose Requirements clause defines the specific quantities and administration schedules of a drug or treatment that must be provided or adhered to under an agreement. It typically outlines the minimum and maximum allowable doses, frequency of administration, and any conditions under which dose adjustments may be made. This clause ensures that both parties are clear on the expectations for dosing, helping to maintain patient safety, regulatory compliance, and consistent treatment outcomes.
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.
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.
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.
Dose Requirements. All Product used or sold by Licensee shall consist of single dose concentrations of Lenacapavir that are the same as the dose concentration for Lenacapavir that has been approved by the FDA or EMA for the equivalent Gilead Lenacapavir Product. Licensee agrees that it shall manufacture and/or sell Product produced according to the standards as set forth in Section 6.2(a) and only as approved by the FDA or EMA 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.
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.
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.
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.
Dose Requirements. All Product used or sold by Licensee shall consist of a single dose concentrations of NTX and M▇▇▇ 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.