Item 5.02 Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain
Officers.
On October 18, 2021, we filed a Current Report on Form 8-K with the Securities
and Exchange Commission disclosing that Neil A. Goldman, our Executive Vice
President and Chief Financial Officer, had notified us that he would be
terminating his employment with our company. We have initiated a search process
to identify and retain a successor chief financial officer. In the interim,
effective as of November 8, 2021 Richard L. Eberly, our Chief Executive Officer
and President, began serving as our principal financial officer and Atif Rizvi,
our Vice President, Finance, began serving as our principal accounting officer.
Biographical information about Mr. Eberly can be found in our definitive proxy
statement filed with the Securities and Exchange Commission on May 13, 2021.
Mr. Rizvi has served as our Vice President, Finance since November 2021 after
having acted as our Controller from June 2019 to November 2021. Mr. Rizvi
previously was employed by L3 Technologies, Inc. (now L3Harris Technologies,
Inc.), a provider of a broad range of communication, electronic and sensor
systems used on military, homeland security and commercial platforms, where he
served as Assistant Segment Controller from July 2017 to June 2019, as a
Financial Planning and Analyst Manager from August 2016 to June 2017, and in
various other accounting and corporate finance roles from 2007 through 2017. Mr.
Rizvi was a Premium Auditor at American International Group, Inc., a
multinational finance and insurance corporation, from 2006 to 2007. Mr. Rizvi is
a Certified Public Accountant and received a Bachelor of Science degree in
Accounting from York College of The City University of New York. He is 42 years
old.
There are no family relationships between Mr. Rizvi and any of our existing
directors or our executive officers, and Mr. Rizvi has not had any direct or
indirect material interest in any transaction required to be disclosed pursuant
to Item 404(a) of Regulation S-K under the Securities Exchange Act of 1934.
Item 8.01 Other Events.
Extension of Delivery Schedule for Bio-Manguinhos Purchase Order
On July 20, 2021, we received a $28.3 million purchase order from
Bio-Manguinhos, or the Bio-Manguinhos Purchase Order, for the purchase of DPP
SARS-CoV-2 Antigen tests for delivery during 2021 to support the needs of
Brazil's Ministry of Health in addressing the COVID-19 pandemic. Bio-Manguinhos,
a subsidiary of the Oswaldo Cruz Foundation (known as Fiocruz), is responsible
for the development and production of vaccines, diagnostics, and
biopharmaceuticals, primarily to meet demands of Brazil's national public health
system. For additional information, please see the information contained in our
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021
filed with the Securities and Exchange Commission, which we refer to as the
Third Quarter 10-Q, including without limitation the information set forth in
the Third Quarter 10-Q under the headings "Part 1. Financial Information-Item 2.
Management's Discussion and Analysis of Financial Condition and Results of
Operations-Recent Events-July Purchase Orders" and "Part II. Other
Information-Item 1A. Risk Factors-Because of our liquidity and operational
limitations, including the availability of staffing and supply chain resources
that are necessary but outside of our control, we will not be able to timely
fulfill all of the requirements of the July Purchase Order from BioManguinhos
and it is difficult to reliably estimate the extent to which we will be able to
timely meet those requirements."
As described in the Third Quarter 10-Q, our delivery of the full number of tests
covered by the Bio-Manguinhos Purchase Order has been, and is expected to
continue to be, negatively affected by limitations of our supply chain, staffing
and liquidity, including matters that are outside our control. Because of those
limitations, at the time of the filing of the Third Quarter 10-Q we expected
that, as set forth in the Third Quarter 10-Q, we would be unable to deliver at
least $11.5 million of the Bio-Manguinhos Purchase Order by December 31, 2021,
the end of the shipment schedule under the order.
On November 12, 2021 Bio-Manguinhos notified us that it was extending the
delivery schedule for shipments under the BioManguinhos Purchase Order to allow
for a portion of the shipments into March 2022. We believe this extension
provides us with an opportunity to timely deliver all of the shipments
contemplated by the BioManguinhos Purchase Order, including the $11.5 million
of shipments that, prior to the extension, we anticipated we would be unable to
deliver by December 31, 2021. We expect, however, that our ability to
manufacture tests covered by the July Purchase Order from Bio-Manguinhos will
continue to be limited in the first quarter of 2021, and the number of
uncertainties related to third parties-including the availability of required
personnel, raw materials and other resources-continue to preclude us from
reliably estimating the extent to which we will be able to fulfill the
BioManguinhos Purchase Order on time and at an acceptable cost, or at all.
Submission of EUA Application for New DPP SARS-CoV-2 Antigen Test System
On November 15, 2021 we submitted an application for an emergency use
authorization, or EUA, to the U.S. Food and Drug Administration for the new DPP
SARS-CoV-2 Antigen test system.
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