United States District Court, E.D. Missouri, Eastern Division
OPINION, MEMORANDUM AND ORDER
EDWARD AUTREY UNITED STATES DISTRICT JUDGE.
matter is before the Court on Defendant's Motion to
Dismiss Count III, [Doc. No. 40]. The motion is fully
briefed. For the reasons set forth below, the Motion is
and Background 
brought this action seeking specific performance and
injunctive relief against Defendant. Plaintiff's First
Amended Complaint alleges breach of contract (Count I), seeks
injunctive relief against a former employee (Count II), and
alleges a breach of an implied warranty of merchantability
respect to Count III, Plaintiffs' Amended Complaint
alleges the following:
Labs manufactures an acellular product known as exosomes. An
exosome is a nano particle lipid vesicle, and the primary
communication device between cells; they transfer ribonucleic
acids, as well as other proteins, between cells for the
primary purpose of healing.
have been used to treat a variety of conditions, but Kimera
Labs' exosomes are marketed for topical applications
time-to-time from February through August 2018, Direct
Biologics purchased exosomes from Kimera Labs. Direct
Biologics sold some but not most of the exosomes it purchased
from Kimera Labs and gave away many samples to doctors for
Labs' failure to receive accreditation from the American
Association of Tissue Banks led Direct Biologics to question
Kimera Labs' manufacturing processes and the quality and
safety of its exosomes. It thus had several samples of the
exosomes in its inventory tested. The exosomes tests were
performed by a firm called RayBiotech, a laboratory known to
be used by Kimera Labs.
test results were significant in that the protein levels in
the samples widely varied where there should have been a
consistent and appreciable amount of detected proteins in
each lot. The test results confirmed Direct Biologics'
concerns regarding Kimera Labs' manufacturing processes,
and the quality of its products. Direct Biologics thus
quarantined its remaining inventory of Kimera Labs'
exosomes, as none of it can be safely sold to a doctor
without first testing its chemical composition.
Labs breached its implied warranty of merchantability in
selling Direct Biologics exosomes that cannot be sold without
first testing for their chemical composition.
Biologics has been damaged by Kimera Labs' breach in that
it paid Kimera Labs more than $100, 000 for the unsellable
exosomes in its inventory.
moves to dismiss Count III for failure to state a cause of
action under Rules 12(b)(6).