What changed in this filing

/stocks — the workspaceLOADING

Item 1. Legal Proceedings

2023-05-10 compared with 2022-11-08 · 23 added, 15 removed, 4 unchanged (90% of the section changed)

LEGAL PROCEEDINGS

From time to time, we are involved in certain legal actions arising in the ordinary course of business.

In management’s opinion, based upon the advice of counsel, the outcomes of such actions are not expected, individually or in the aggregate, to have a material adverse effect on our future financial position or results of operations.

From time to time, the Company is involved in certain legal actions arising in the ordinary course of business.

In management’s opinion, based upon the advice of counsel, the outcomes of such actions are not expected, individually or in the aggregate, to have a material adverse effect on the Company's future financial position or results of operations.

Spectrum Patent Litigation

In March 2021, we filed a complaint against Spectrum Solutions, LLC ("Spectrum") in the United States District Court for the Southern District of California alleging that certain saliva collection devices manufactured and sold by Spectrum infringe a patent held by DNAG.

Spectrum has filed an answer to the initial complaint, asserting that its device does not infringe our patent and that our patent is invalid.

In August 2021, we amended our complaint to add a second patent to this litigation.

Spectrum responded to our amended complaint and asserted counterclaims for inequitable conduct and antitrust violations with respect to one of the patents in the litigation and subsequently filed a request for review of the second patent at the Patent and Trademark Office.

DNAG filed a motion to dismiss Spectrum’s counterclaims in October 2021, which was denied by the Court on March 30, 2022.

Fact discovery is ongoing.

The final pretrial conference is set for September 7, 2023

In March 2021, the Company filed a complaint against Spectrum Solutions, LLC ("Spectrum") in the United States District Court for the Southern District of California alleging that certain saliva collection devices manufactured and sold by Spectrum infringe a patent held by DNAG.

Spectrum has filed an answer to the initial complaint, asserting that its device does not infringe the Company's patent and that the Company's patent is invalid.

In August 2021, the Company amended its complaint to add a second patent to this litigation.

Spectrum responded to the Company's amended complaint and asserted counterclaims for inequitable conduct and antitrust violations with respect to one of the patents in the litigation and subsequently filed a request for review of the second patent at the Patent and Trademark Office ("PTO"), which was granted by the PTO.

On May 2, 2023, the District Court issued two orders.

First, the District Court granted Spectrum’s motion for summary judgment of noninfringement, holding that Spectrum’s saliva collection devices are not “kits for collecting and preserving a biological sample,”

among other rulings.

The Company intends to appeal the Court’s grant of summary judgment.

Second, the Court denied Spectrum’s motion to supplement its allegations of alleged antitrust violations.

A separate motion by Spectrum to amend its counterclaims remains pending.

An inter partes review is currently pending before the PTO regarding the second asserted patent.

The final pretrial conference in the District Court is set for October 26, 2023.

RI SK FACTORS

There have been no material changes to the risk factors disclosed in Item 1A, entitled “Risk Factors,”

in our Annual Report on Form 10-K for the year ended December 31, 2021, other than as set forth below.

Customer Concentration Creates Risk for Our Business.

One non-commercial customer accounted for 69% and 53% of net consolidated revenues for the three and nine months ended September 30, 2022.

We expect that sales to the large non-commercial customer will continue to be a significant contributor to our net consolidated revenue.

Certain parts of our business may continue to have a high customer concentration and depend disproportionately on a few large customers.

To the extent that such a large customers fail to meet their purchase commitments, change their ordering patterns or business strategies, or otherwise reduce their purchases or stop purchasing our products, or if we experience difficulty in meeting the high demand by these larger customers for our products, our revenues and results of operations could be adversely affected.

in the Company's Annual Report on Form 10-K for the year ended December 31, 2022, other than as set forth below.

Conditions in the banking system and financial markets, including the failure of banks and financial institutions, could have an adverse effect on our operations and financial results.

Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems.

For example, on March 10 and March 12, 2023, the Federal Deposit Insurance Corporation took control and was appointed receiver of Silicon Valley Bank, and Signature Bank and Silvergate Capital Corp, respectively, after each bank was unable to continue their operations.

Since then, additional financial institutions have experienced similar failures and have been placed into receivership.

It is possible that other banks will face similar difficulty in the future.

Although we do not maintain any deposit accounts, credit agreements or letters of credit with any financial institution currently in receivership, we are unable to predict the extent or nature of the impacts of these evolving circumstances at this time.

If, for example, other banks and financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting the banking system and financial markets, our ability to access our existing cash, cash equivalents and investments may be threatened.

While it is not possible at this time to predict the extent of the impact that the failure of these financial institutions or the high market volatility and instability of the banking sector could have on economic activity and our business in particular, the failure of other banks and financial institutions and the measures taken by governments, businesses and other organizations in response to these events could adversely impact our business, financial condition and results of operations.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Legal Proceedings