Lawsuit Alleges Producer of Exosomes and Amniotic Fluid is Violating Multiple Federal Drug Administration Guidelines Including Intentionally Shipping Out Expired Products

A lawsuit (Case# CACE-20-000455) been filed by Nevada-based Age Bio Marq Lab, LLC (ABM) against Kimera Labs, a manufacturer of stem cell derived exosomes and amniotic fluid. The lawsuit alleges that Kimera Labs has engaged in several illegal practices including: theft of trade secrets, internal mislabeling of the expiration date of biologic products, circumventing distributors by creating direct relationships with distributor’s clients at significantly better pricing, intentionally manipulating accounting figures, promotion of questionable manufacturer product opinions that are not in compliance with the Federal Drug Administration’s (FDA) guidance, and attempting to collect revenues already paid.

According to the complaint filed in the Circuit Court of the 17th Judicial Circuit in and for Broward County, Florida, Age Bio Marq Lab, which operates its distribution business as Stem Excell, executed a distribution agreement with Kimera Labs, the manufacturer of the FDA-regulated biologic product commonly known as exosomes. Exosomes are derived from stem cells growing in Kimera Labs’ facilities in Miramar, FL.

ABM alleges that many of the provisions of the distribution agreement have been violated by Kimera Labs and its employee and officer Adam Koster. Per the agreement, Kimera Labs agreed to protect the Age Bio Marq Lab’s relationships that it utilizes when selling its products. The agreement further assured that products manufactured by Kimera Labs are legal and compliant with Federal Laws and all relevant statutes. ABM alleges the products sold by Kimera Labs are not in compliance. The lawsuit includes recent letters and actions by the FDA supporting that allegation.

In February 2019, ABM began sending correspondence to Kimera Labs to inform them of the problems Koster was causing, including a cease and desist letter sent in September 2019. The lawsuit alleges the manufacturer disregarded all correspondence and refused to prevent Koster from continuing to cause damages to ABM’s operation. As described in the lawsuit, that damage includes Kimera Labs hiring of Koster to target clients of their distributors to increase its profit margin by not paying the distributors for distribution of the manufactured product.

ABM also alleges that Kimera Labs intended to violate the trade secrets and other provisions of its contract with ABM and also intentionally shipped out expired products. The lawsuit details a process orchestrated by the defendent to relabel expired products and extend the product expiration date.

Source – PRWeb

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