Examples of HIV Product in a sentence
Selfcare agrees that it will not sell or distribute the HIV Product or clinical data relating to the HIV Product without complying with all applicable regulations.
To the extent required under applicable European Union regulations, Selfcare shall charge the same price for HIV Product in countries in the Territory that are members of the European Union.
Selfcare hereby acknowledges that the ChemTrak Technology, particularly ChemTrak's proprietary Software and the data and regulatory strategy reflected in ChemTrak's filings with the U.S. FDA regarding the HIV Product, has been maintained by ChemTrak as highly confidential and constitutes ChemTrak's proprietary and extremely valuable trade secret information.
All reports, forecasts and plans generated by or for Selfcare with respect to the HIV Product and provided to ChemTrak under this Article 6 (collectively, the "Marketing Data") shall constitute Confidential Information of Selfcare, as defined under Article 8 hereof.
Selfcare shall have sole responsibility for diligently pursuing Regulatory Approval of the HIV Product throughout the Territory as soon as practicable, and for bearing all costs associated therewith.
Selfcare represents that it is familiar with and agrees to comply with all such regulations, including any future modifications thereof, in connection with the distribution of the HIV Product.
The Parties intend that this Agreement set forth all of the terms and conditions applicable to the sale of the HIV Product and accordingly agree that all provisions, terms and conditions of any purchase order, sales or order acknowledgment, invoice or other business form or document (a "Form"), unless an amendment to this Agreement in accordance with Section 13.5 hereof, shall be superseded hereby and therefore shall be disregarded and have no force and effect.
ChemTrak will provide Selfcare with a copy of all documentation required by the U.S. FDA in connection with its review of the HIV Product, including a right to reference all applications, registrations, and supporting documents submitted and received by ChemTrak, and will provide assistance in connection with the pursuit of Regulatory Approvals in the Territory according to a plan to be mutually agreed upon.
Within thirty (30) days after the receipt of the first Regulatory Approval for HIV Product in a country in the Territory, Selfcare shall submit to ChemTrak an initial purchase order for a mutually agreed upon number of Sample Collection Kits based on the predicted number necessary to launch the product.
ChemTrak shall have the right to review and comment on such plan before Selfcare makes any contact with any regulatory agency pertaining to the HIV Product in the Territory.