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Re: Screech691 post# 375

Tuesday, 11/22/2016 11:59:32 AM

Tuesday, November 22, 2016 11:59:32 AM

Post# of 628
In exchange for the above milestone and royalty payments Jenex will commit to obtaining all regulatory approvals with the FDA and other regulatory requirements in jurisdictions outside of the U.S. deemed necessary to market the product. Jenex will use its current FDA license for its former thermal therapy insect device and intends to apply for a Class II medical device that is indicated for the relief of the pain, itch, and inflammation from over 20,000 different insect stings and bites including bees, wasps, hornets, mosquitoes, black flies, and jelly fish. Jenex received approval for the above claims from the FDA (United States) in 1997. Jenex will utilize its ISO 13485 Quality Management System in any market that Luminar intends to market.