Item 3. Legal Proceedings
Item
3. Legal Proceedings.
As
previously disclosed, on April 14, 2017, representatives for the estate of an individual plaintiff filed a wrongful death complaint with
the Suffolk Superior Court, in the County of Suffolk, Massachusetts, against us and other defendants, including Harvard Bioscience, Inc.,
or HBIO, the former parent of the Company that spun off the Company in 2013, as well as another third party. The complaint sought payment
for an unspecified amount of damages and alleged that the plaintiff sustained terminal injuries allegedly caused by products provided
by certain of the named defendants and utilized in connection with surgeries performed by third parties in Europe in 2012 and 2013. This
lawsuit relates to our first-generation trachea scaffold technology for which we discontinued development in 2014, and not to our current
esophageal implant.
On
April 27, 2022, the Company and HBIO executed a settlement with the plaintiffs (the “Settlement”), which resolves all claims
relating to the litigation. The Settlement resulted in the dismissal with prejudice of the wrongful death claim, and neither we nor HBIO
admitted any fault or liability in connection with the claim. The Settlement also resolved any and all claims by and between the parties
and our products liability insurance carriers, which resulted in the dismissal with prejudice of all claims asserted by or against those
carriers, the Company and HBIO. However, based on review of the circumstances surrounding the Settlement, we recorded an accrual for
this matter of approximately $3.3 million in general and administrative expenses during the year ended December 31, 2021.
In
relation to the litigation, we have incurred approximately $5.9 million of aggregate costs, all of which has been paid as of
December 31, 2022. This aggregate amount includes the cost of both the accrual for contingency matter of approximately $3.3 million
and approximately $2.6 million of legal and related costs incurred by us which consist of attorney’s fees and advisor and
specialist costs as part of our defense in this matter. For the year ended December 31, 2022, we incurred legal and related costs of
approximately $1.3 million recorded in general and administrative expenses. On March 3, 2022, we received a cash payment of
approximately $0.1 million from Medmarc, our insurance carrier. This amount represented a reimbursement of previously incurred legal
costs and was recorded as a reduction to general and administrative expenses during the year ended December 31, 2022.
With
respect to such $5.9 million of costs described above, we were required to either pay such costs directly or indemnify HBIO as to such
amounts it incurs. With respect to the indemnification obligation of the Company to HBIO pertaining to such costs, we and HBIO entered into a Preferred
Issuance Agreement dated as of April 27, 2022, or the PIA. In connection with the PIA, we and HBIO agreed that once HBIO
had paid at least $4.0 million in such costs, to satisfy our indemnification obligations with respect thereto, in lieu of paying cash,
we would issue senior convertible preferred stock to HBIO that will contain terms as described in the PIA, including the term sheet attached
thereto. On June 10, 2022, following the execution of a subscription agreement and HBIO providing evidence of payment of the requisite
$4.0 million amount, we issued HBIO 4,000 shares of Series E Preferred Stock at a price of $1,000 per share to satisfy our related indemnification
obligations aggregating $4.0 million, which included the accrual for contingency of approximately $3.3 million and approximately $0.8
million of legal and related costs paid on behalf of the Company by HBIO.
From
time to time, we may be involved in various claims and legal proceedings arising in the ordinary course of business. Other than the above
matter, there are no such matters pending that we expect to be material in relation to its business, financial condition, and results
of operations or cash flows.
Item
4. Mine Safety Disclosures.
Not
Applicable.
43
PART
II
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.