Common use of TESTING FACILITIES; COUNSELING SERVICE Clause in Contracts

TESTING FACILITIES; COUNSELING SERVICE. Prior to obtaining the first Regulatory Approval in the Territory, Selfcare shall establish or contract for a single central laboratory (or more as Selfcare determines is reasonable or necessary) to conduct HIV testing in accordance with the protocols and procedures described in ChemTrak's submissions to the U.S. FDA or amended, as required by a country's regulatory authorities, (a "TESTING FACILITY"). ChemTrak shall provide Selfcare with a copy of the Software for use at each such facility for the processing of HIV Tests during the term of this Agreement. At such time Selfcare shall also establish a counseling service to report results to customers and provide appropriate counseling regarding the results, again as provided in ChemTrak's submissions to FDA or amended, as required by a country's regulatory authorities, (the "COUNSELING SERVICE"). Selfcare shall bear all costs associated with establishing the Testing Facilities and the Counseling Service, including any additional requirements of the countries in the Territory. ChemTrak shall have the right to inspect the Testing Facilities and Counseling Service during normal business hours (after giving reasonable notice) in order to ensure that each is operating in the manner described in ChemTrak's FDA documentation or amended, as required by a country's regulatory authorities, and in accordance with all applicable regulatory standards.

TESTING FACILITIES; COUNSELING SERVICE. Prior to obtaining the first Regulatory Approval in the Territory, Selfcare shall establish or contract for a single central laboratory (or more as Selfcare determines is reasonable or necessary) to conduct HIV testing in accordance with the protocols and procedures described in ChemTrak's submissions to the U.S. FDA or amended, as required by a country's regulatory authorities, (a "TESTING FACILITY"). ChemTrak shall provide Selfcare with a copy of the Software for use at each such facility for the processing of HIV Tests during the term of this Agreement. At such time Selfcare shall also establish a counseling service to report results to customers and provide appropriate counseling regarding the results, again as provided in ChemTrak's submissions to FDA or amended, as required by a country's regulatory authorities, (the "COUNSELING SERVICE"). Selfcare shall bear all costs associated with establishing the Testing Facilities and the Counseling Service, including any additional requirements of the countries in the Territory. ChemTrak shall have the right to inspect the Testing Facilities and Counseling Service during normal business hours (after giving reasonable notice) in order to ensure that each is operating in the manner described in ChemTrak's FDA documentation or amended, as required by a country's regulatory authorities, and in accordance with all applicable regulatory standards.. 3.3