You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes included in this Quarterly Report on Form 10-Q and those in our Annual Report on Form 10-K for the year ended December 31, 2019. Some of the information contained in this discussion and analysis or set forth elsewhere in this report, including statements related to our expectations regarding the potential impacts of the COVID-19 pandemic on our business, financial condition, and results of operations, and information with respect to our products, plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties, including statements regarding our expected financial results in future periods. The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "might," "plans," "potential," "predicts," "projects," "seeks," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. You should read the "Risk Factors" section of this Quarterly Report on Form 10-Q for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. We do not assume any obligation to update any forward-looking statements.

Termination of Merger with Illumina, Inc.

On January 2, 2020, we, Illumina and Merger Subsidiary entered into the Termination Agreement. As part of the Termination Agreement, Illumina paid us a $98.0 million Reverse Termination Fee, from which we paid our financial advisor associated fees of $6 million in April 2020. In addition, Illumina paid us the final Continuation Advances of $34 million during the first quarter of 2020.

However, pursuant to the Termination Agreement, in the event that, on or prior to September 30, 2020, we entered into a definitive agreement providing for, or consummated, a Change of Control Transaction (as defined in the Termination Agreement), then we may have been required to repay the Reverse Termination Fee (without interest) to Illumina in connection with the consummation of such Change of Control Transaction. No such definitive agreement was entered into nor was a Change of Control Transaction consummated as of September 30, 2020. The $98.0 million in cash we received from Illumina for the reverse termination fee was recorded as a short-term liability as of September 30, 2020 and, on October 1, 2020, after the contingency clauses lapsed, it was subsequently recognized as a gain and will be reflected in the fourth quarter of 2020 as Other Income.

In addition, up to the $52.0 million of Continuation Advances paid to us are repayable without interest to Illumina if, within two years of March 31, 2020, we enter into a Change of Control Transaction or raise at least $100 million in a single equity or debt financing (that may have multiple closings), with the amount repayable dependent on the amount raised by us.

Senior Management

Our President and Chief Executive Officer Christian O. Henry was appointed effective September 14, 2020, succeeding Dr. Michael Hunkapiller who announced his retirement, which will be effective at the end of the year. Our Chief Financial Officer Susan G. Kim was appointed effective September 28, 2020, succeeding Susan K. Barnes who retired on August 7, 2020. Also, our Vice President and Chief Accounting Officer Eric E. Schaefer was appointed effective May 26, 2020, and our Chairman of the Board Dr. John F. Milligan was appointed effective September 14, 2020.

Business Overview

We design, develop and manufacture sequencing systems to help scientists resolve genetically complex problems. Based on our novel Single Molecule, Real-Time (SMRT®) sequencing technology, our products enable: de novo genome assembly to finish genomes in order to more fully identify, annotate and decipher genomic structures; full-length transcript analysis to improve annotations in reference genomes, characterize alternatively spliced isoforms in important gene families, and find novel genes; targeted sequencing to more comprehensively characterize genetic variations; and real-time kinetic information for epigenome characterization. Our technology provides high accuracy, ultra-long reads, uniform coverage and the ability to simultaneously detect epigenetic changes. PacBio® sequencing systems, including consumables and software, provide a simple and fast end-to-end workflow for SMRT sequencing.



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Our current products include the Sequel II instrument and SMRT Cell 8M, which together are capable of sequencing up to approximately eight million DNA molecules simultaneously, and the previous generation Sequel instrument and Sequel SMRT Cell 1M, which together are capable of sequencing up to approximately one million DNA molecules simultaneously. In October 2020, we launched the Sequel IIe System, which has increased computational capacity, and is designed to enable customers to generate PacBio HiFi reads more efficiently.

Our customers and our scientific collaborators have published numerous peer-reviewed articles in journals including Nature, Science, Cell, PNAS and The New England Journal of Medicine highlighting the power and applications of SMRT sequencing in projects such as finishing genomes, structural variation discovery, isoform transcriptome characterization, rare mutation discovery and the identification of chemical modifications of DNA related to virulence and pathogenicity. Our research and development efforts are focused on developing new products and further improving our existing products including continuing chemistry and sample preparation improvements to increase throughput and expand our supported applications. By providing access to genetic information that was previously inaccessible, we enable scientists to confidently increase their understanding of biological systems.

COVID-19 Update

The COVID-19 pandemic and efforts to control its spread have significantly curtailed the movement of people, goods, and services worldwide, including in the regions in which we sell our products and services and conduct our business operations. The financial results for the three and nine months ended September 30, 2020 were impacted negatively as many of our customers in multiple regions around the world shut down operations for various periods of time in efforts to curb the spread of the COVID-19 pandemic. This resulted in lower product revenues for the three and nine months ended September 30, 2020 as compared to the same periods of 2019. A significant number of our customer sites that had shut down due to COVID-19 have re-opened. In addition, a significant number of customers have delayed purchases or difficulties obtaining funding for capital expenditures due to the negative impact of the pandemic on their businesses. This dynamic continues to negatively impact the recognition of revenue related to the sale of our Sequel and Sequel II instruments. The negative impacts of COVID-19 on our customers will likely continue to adversely impact our revenues during the fourth quarter of 2020. Due to the uncertain scope and duration of the pandemic, we cannot reasonably estimate the future impact to our operations and financial results.

In response to local stay-at-home orders and in alignment with CDC recommendations, we have limited our manufacturing and commercial operations based in Menlo Park, California. We will, however, continue to provide consumables, instruments and support to scientists at government, academic, and commercial labs that remain open. To aid in containing the spread of COVID-19, we have implemented remote-work options and are limiting employee travel as much as possible. We are monitoring this rapidly evolving situation.

Even after the COVID-19 pandemic has subsided, we may continue to experience an adverse impact to our business as a result of its global economic impact, including any recession that has occurred or may occur in the future. Specifically, difficult macroeconomic conditions, decreases in discretionary capital spending, increased and prolonged unemployment or a decline in consumer confidence as a result of the COVID-19 pandemic could have a continuing adverse effect on the demand for some of our products. Such economic disruption could have a material adverse effect on our business, results of operations and liquidity. The degree of impact of COVID-19 on our business will depend on several factors, such as the duration and the extent of the pandemic, as well as actions taken by governments, businesses and consumers in response to the pandemic, all of which continue to evolve and remain uncertain at this time. See the Risk Factors section for further discussion of the possible impact of the COVID-19 pandemic on our business.

Critical Accounting Policies and Estimates

The discussion and analysis of our financial condition and results of operations are based upon our unaudited Financial Statements, which have been prepared in accordance with the rules and regulations of the SEC. The preparation of these Financial Statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate our critical accounting policies and estimates. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

We adopted ASU 2016-13 Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments on January 1, 2020, using the modified retrospective method. Please see "Recently Adopted Accounting Standards" in the Note 3. Summary of Significant Accounting Policies of Item 1. Financial Statements.

Except as noted above, there have been no other material changes to our significant accounting policies as discussed in our Annual Report on Form 10-K for the year ended December 31, 2019.



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Results of Operations

Comparison of the three months ended September 30, 2020 and 2019



                                     Three Months Ended September 30,    $ Change    % Change
(in thousands, except percentages)          2020              2019
                                                 (unaudited)
Revenue:
Product revenue                      $           15,749    $    18,484   $ (2,735)       (15%)
Service and other revenue                         3,333          3,431        (98)        (3%)
Total revenue                                    19,082         21,915     (2,833)       (13%)
Cost of Revenue:
Cost of product revenue                           9,228         12,188     (2,960)       (24%)
Cost of service and other revenue                 2,790          2,813        (23)        (1%)
Total cost of revenue                            12,018         15,001     (2,983)       (20%)
Gross profit                                      7,064          6,914         150          2%
Operating Expense:
Research and development                         16,467         14,962       1,505         10%
Sales, general and administrative                14,772         20,066     (5,294)       (26%)
Total operating expense                          31,239         35,028     (3,789)       (11%)

Operating loss                                 (24,175)       (28,114)       3,939         14%
Interest expense                                      -          (664)         664        100%
Other income, net                                   467          (345)         812        235%
Net loss                             $         (23,708)    $  (29,123)   $   5,415         19%


Revenue

Total revenue for the three months ended September 30, 2020 was $19.1 million compared to $21.9 million for the same period during 2019.

Product revenue of $15.7 million for the three months ended September 30, 2020 consisted primarily of $7.7 million from instrument revenue and $8.0 million from consumables revenue, compared to total product revenue of $18.5 million for the same period during 2019, consisting of $11.6 million from instrument revenue and $6.9 million of consumables revenue. The decrease in instrument sales was primarily attributable to a lower number of instrument shipments and installations due to COVID-19 as discussed above. The increase in consumable sales was primarily attributable to higher Sequel II consumables sales. The negative impact of COVID-19 on our customers will likely continue to adversely impact our revenues during the fourth quarter of 2020.

Service and other revenue of $3.3 million and $3.4 million for the three months ended September 30, 2020 and 2019, respectively, was primarily derived from product maintenance agreements sold on our installed instruments.

Gross Profit

Gross profit for the three months ended September 30, 2020 was $7.1 million, resulting in a gross margin of 37.0%, compared to gross profit of $6.9 million, resulting in a gross margin of 31.5% for the same period during 2019.

Cost of product revenue was $9.2 million for the three months ended September 30, 2020, compared to cost of product revenue of $12.2 million for the same period during 2019. The decrease of $3.0 million in cost of product revenue was primarily attributable to our incurring $2.8 million of product transition costs including inventory reserves taken in connection with the transition from Sequel to Sequel II during the three months ended September 30, 2019, partially offset by lower factory production in the three months ended September 30, 2020 resulting in under-absorbed overhead.

Cost of service and other revenue for the three months ended September 30, 2020 was $2.8 million, compared to $2.8 million for the same period during 2019.

Research and Development Expense

During the three months ended September 30, 2020, research and development expense increased by $1.5 million, or 10%, compared to the same period during 2019. The increase in research and development expense was primarily driven by higher chip development costs. Research and development expense included stock-based compensation expense of $2.1 million and $1.9 million during the three months ended September 30, 2020 and 2019, respectively.



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Sales, General and Administrative Expense

During the three months ended September 30, 2020, sales, general and administrative expense decreased by $5.3 million, or 26%, compared to the same period during 2019. The decrease in sales, general and administrative expense was primarily attributable to $3.6 million in merger related expenses during the three months ended September 30, 2019, which did not recur during the three months ended September 30, 2020, and a decrease of $1.4 million in patent litigation expenses incurred during the three months ended September 30, 2020 as compared to the same period in 2019. Sales, general and administrative expense included stock-based compensation expense of $2.2 million and $1.7 million during the three months ended September 30, 2020 and 2019, respectively.

Interest Expense

Interest expense for the three months ended September 30, 2020 decreased $0.7 million compared to the same period in 2019, as the debt agreement with Deerfield entered into in February 2013 (the "Facility Agreement") matured in February 2020.

Other Income

The $98.0 million in cash we received from Illumina for the Reverse Termination Fee was recorded as a short-term liability as of September 30, 2020. On October 1, 2020, the contingency clauses lapsed and, as a result, we expect to recognize a gain of $98 million in our fourth quarter of 2020 financial results.

Comparison of the nine months ended September 30, 2020 and 2019



                                 Nine Months Ended September 30,       $ Change    % Change
(in thousands, except                2020               2019
percentages)
                                            (unaudited)
Revenue:
Product revenue                $          41,798   $        53,191    $ (11,393)      (21%)
Service and other revenue                  9,959             9,770           189         2%
Total revenue                             51,757            62,961      (11,204)      (18%)
Cost of Revenue:
Cost of product revenue                   22,874            32,786       (9,912)      (30%)
Cost of service and other
revenue                                    7,718             8,531         (813)      (10%)
Total cost of revenue                     30,592            41,317      (10,725)      (26%)
Gross profit                              21,165            21,644         (479)       (2%)
Operating Expense:
Research and development                  46,727            45,357         1,370         3%
Sales, general and
administrative                            54,846            58,915       (4,069)       (7%)
Total operating expense                  101,573           104,272       (2,699)       (3%)

Operating loss                          (80,408)          (82,628)         2,220         3%
Gain from Continuation
Advances from Illumina                    34,000                 -
Interest expense                           (267)           (1,933)         1,666        86%
Other income, net                          1,143               518           625       121%
Net loss                       $        (45,532)   $      (84,043)    $   38,511        46%


Revenue

Total revenue for the nine months ended September 30, 2020 was $51.8 million, compared to $63.0 million for the same period during 2019.

Product revenue of $41.8 million for the nine months ended September 30, 2020 consisted of $20.7 million from sales of Sequel and Sequel II instruments and $21.1 million from sales of consumables, compared to total product revenue of $53.2 million for the same period during 2019, consisting of $29.9 million from sales of Sequel and Sequel II instruments and $23.3 million from sales of consumables. The decrease in instrument sales was primarily attributable to a lower number of instrument shipments and installations due to COVID-19 as discussed above. The decrease in consumable sales was primarily attributable to lower utilization of the installed base of instruments due to COVID-19 as discussed above. The negative impact of COVID-19 on our customers will likely continue to adversely impact our revenues during the fourth quarter of 2020.



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Service and other revenue of $10.0 million and $9.8 million for the nine months ended September 30, 2020 and 2019, respectively, was primarily derived from product maintenance agreements sold on our installed instruments.

Gross Profit

Gross profit for the nine months ended September 30, 2020 was $21.2 million, resulting in a gross margin of 41.9%, compared to gross profit of $21.6 million, resulting in a gross margin of 34.4% for the same period during 2019. Gross margin for the nine months ended September 30, 2019 was negatively impacted by product transition costs, including inventory reserves taken in connection with the transition from Sequel to Sequel II.

Cost of product revenue was $22.9 million for the nine months ended September 30, 2020, compared to cost of product revenue of $32.8 million for the same period during 2019. Cost of product revenue decreased by $10.0 million for the nine months ended September 30, 2020 compared to the same period in 2019 primarily resulting from lower product shipments. In addition, during the nine months ended September 30, 2019, we incurred product transition costs including an inventory reserve taken in connection with the transition from Sequel to Sequel II.

Cost of service and other revenue for the nine months ended September 30, 2020 was $7.7 million, compared to $8.5 million for the same period during 2019.

Research and Development Expense

During the nine months ended September 30, 2020, research and development expense increased by $1.4 million, or 3%, compared to the same period during 2019. The increase in research and development expense was primarily driven by higher chip development costs. Research and development expense included stock-based compensation expense of $5.3 million and $5.8 million during the nine months ended September 30, 2020 and 2019, respectively.

Sales, General and Administrative Expense

During the nine months ended September 30, 2020, sales, general and administrative expense decreased by $4.1 million, or 7%, compared to the same period during 2019. The decrease in sales, general and administrative expense was primarily attributable to the acquisition-related legal fees of $12.8 million incurred for the nine months ended September 30, 2019, partially offset by $6.0 million merger advisory fee incurred in the first quarter of 2020; an increase of $1.2 million in salary and bonus expenses for the nine months ended September 30, 2020, an increase of $1.2 million in litigation expenses for the nine months ended September 30, 2020. Sales, general and administrative expense included stock-based compensation expense of $5.2 million and $5.3 million during the nine months ended September 30, 2020 and 2019, respectively.

Interest Expense

Interest expense for the nine months ended September 30, 2020 decreased $1.7 million compared to the same period in 2019, as the Facility Agreement matured in February 2020.

Liquidity and Capital Resources

Liquidity

Cash, cash equivalents and investments at September 30, 2020 totaled $208.6 million, compared to $49.1 million at December 31, 2019. The increase was attributable to the proceeds from our public offering of common stock completed in August 2020, as well as the Reverse Termination Fee and Continuation Advances we received from Illumina, partially offset by cash used in operations and a $16.0 million repayment of debt in the first quarter of 2020. We believe that our existing cash, cash equivalents and investments will be sufficient to fund our projected operating requirements for at least the next 12 months from the date of filing of this Quarterly Report on Form 10-Q for the quarter ended September 30, 2020. However, the potential economic or other disruptions caused by the COVID-19 pandemic could have a material adverse effect on our business, results of operations and liquidity. We will continue to monitor our operating expenses and cash flows in response to the evolving market conditions.

On January 2, 2020, we and Illumina mutually agreed to terminate the Merger Agreement. As part of the Termination Agreement, up to $52.0 million of the Continuation Advances that we received from Illumina are repayable without interest to Illumina if, within two years of March 31, 2020, we enter into, or consummate a Change of Control Transaction or raise at least $100 million in a single equity or debt financing (may have multiple closings), with the amount repayable dependent on the amount raised by us.



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Factors that may affect our capital needs include, but are not limited to, whether we will have to repay the Continuation Advances; the pace of adoption of our products which affects the sales of our products and services; our ability to obtain new collaboration and customer arrangements; the progress of our research and development programs; initiation or expansion of research programs and collaborations; the purchase of patent licenses; future acquisitions; manufacturing costs, service costs, the impact of product quality, litigation costs, including the costs involved in preparing, filing, prosecuting, defending and enforcing intellectual property rights; costs of developing new and enhanced products; and other factors.

We expect to raise additional capital in the future. To the extent that we raise additional funds through the sale of equity or convertible debt, the issuance of such securities will result in dilution to our stockholders. There can be no assurance that such funds will be available on favorable terms, or at all, particularly in light of restrictions under the Termination Agreement. If adequate funds are not available, we may be required to obtain funds by entering into collaboration, licensing or debt agreements on unfavorable terms. If we are unable to raise funds on favorable terms, or at all, we may have to reduce our cash burn rate and may not be able to support our commercialization efforts, or to increase or maintain the level of our research and development activities. If we are unable to generate sufficient cash flows or to raise adequate funds to finance our forecasted expenditures, we may have to make significant changes to our operations, including delaying or reducing the scope of, or eliminating some or all of, our development programs. We also may have to reduce sales, marketing, engineering, customer support or other resources devoted to our existing or new products or cease operations. If our cash, cash equivalents and investments are insufficient to fund our projected operating requirements, and we are unable to raise capital, it would have a material adverse effect on our business, financial condition and results of operations.

Operating Activities

Our primary uses of cash in operating activities are for the development of ongoing product enhancements and future products, manufacturing, and support functions related to our sales, general and administrative activities.

We had $33.8 million of cash provided from operating activities for the nine months ended September 30, 2020, compared to cash usage of $60.1 million from operating activities for the same period in 2019.

Cash provided by operating activities for the nine months ended September 30, 2020 was due to the $98.0 million Reverse Termination Fee received from Illumina, non-cash items such as stock-based compensation of $12.3 million and depreciation of $4.8 million, partially offset by a net loss of $45.5 million and a gain from Continuation Advances from Illumina of $34.0 million, which is considered to be a financing activity. The change in net operating assets and liabilities was primarily attributed to a decrease of $3.4 million in accounts receivable, partially offset by an increase of $3.0 million in inventory.

Cash used in operating activities for the nine months ended September 30, 2019 was due primarily to a net loss of $84.0 million, offset by non-cash items such as stock-based compensation of $12.5 million and depreciation of $5.5 million. The change in net operating assets and liabilities was primarily attributed to an increase of $1.4 million in accounts receivable, partially offset by an increase of $4.9 million in accrued expenses and a decrease of $2.3 million in inventory.

Investing Activities

Our investing activities consist primarily of capital expenditures and investment purchases, sales and maturities. We used $120.8 million of cash for investing activities for the nine months ended September 30, 2020, compared to receiving cash of $65.5 million from investing activities for the same period in 2019.

Cash used in investing activities for the nine months ended September 30, 2020 was due primarily to net purchases of investments of $119.9 million and purchases of property and equipment of $1.0 million.

Cash provided in investing activities for the nine months ended September 30, 2019 was due primarily to net maturities of investments of $68.2 million.

Financing Activities

Cash provided from financing activities was $126.0 million and $8.4 million for the nine months ended September 30, 2020 and 2019, respectively.



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Cash provided by financing activities during the nine months ended September 30, 2020 stemmed from the net proceeds of $93.8 million from our August 2020 underwritten public equity offering after deducting underwriter commissions and paid offering expenses, $34.0 million of Continuation Advances from Illumina and proceeds of $14.2 million from the issuance of common stock through our equity compensation plans, partially offset by $16.0 million we repaid for the remaining outstanding principal to Deerfield upon the maturity of the Facility Agreement.

Cash provided by financing activities during the nine months ended September 30, 2019 was due to $8.4 million from the issuance of common stock through our equity compensation plans.

Capital Resources

In June 2020, we filed a shelf registration statement on Form S-3 with the SEC pursuant to which we may, from time to time, sell up to an aggregate of $250.0 million of our common stock, preferred stock, depository shares, warrants, units or debt securities. On July 14, 2020, the registration statement was declared effective by the SEC, which allows us to access the capital markets for the three-year period following this effective date.

In August 2020 we entered into an underwriting agreement, relating to the public offering of 19,430,000 shares of our common stock, $0.001 par value per share, at a price to the public of $4.47 per share. Under the terms of the underwriting agreement, we also granted the underwriters a 30-day option to purchase up to an additional 2,914,500 shares of our common stock, which was subsequently exercised in full, and the offering including the sale of shares of common stock subject to the underwriters' option, closed in August 2020. In total, we sold 22.3 million shares of our common stock. We paid a commission equal to 6% of the gross proceeds from the sale of shares of our common stock. The total net proceeds to us from the offering after deducting the underwriting discount were approximately $93.9 million, excluding approximately $0.3 million of offering expenses, $0.2 million of which was unpaid as of September 30, 2020. As a result, $150.1 million remains available under the current shelf registration.

However, the Termination Agreement currently limits our ability to issue additional securities or incur indebtedness as up to the $52.0 million of Continuation Advances paid to us are repayable without interest to Illumina if, within two years of March 31, 2020, we enter into a Change of Control Transaction or raise at least $100 million in a single equity or debt financing (that may have multiple closings), with the amount repayable dependent on the amount raised by us.

Off-Balance Sheet Arrangements

As of September 30, 2020, we did not have any off-balance sheet arrangements.

In the ordinary course of business, we enter into standard indemnification arrangements. Pursuant to these arrangements, we indemnify, hold harmless, and agree to reimburse the indemnified parties for losses suffered or incurred by the indemnified party in connection with any trade secret, copyright, patent or other intellectual property infringement claim by any third party with respect to its technology, or from claims relating to our performance or non-performance under a contract, any defective products supplied by us, or any acts or omissions, or willful misconduct, committed by us or any of our employees, agents or representatives. The term of these indemnification agreements is generally perpetual after the execution of the agreement. The maximum potential amount of future payments we could be required to make under these agreements is not determinable because it involves claims that may be made against us in future periods but have not yet been made. To date, we have not incurred costs to defend lawsuits or settle claims related to these indemnification agreements.

We also enter and have entered into indemnification agreements with our directors and officers that may require us to indemnify them against liabilities that arise by reason of their status or service as directors or officers, except as prohibited by applicable law. In addition, we may have obligations to hold harmless and indemnify third parties involved with our fundraising efforts and their respective affiliates, directors, officers, employees, agents or other representatives against any and all losses, claims, damages and liabilities related to claims arising against such parties pursuant to the terms of agreements entered into between us and such third parties in connection with such fundraising efforts. To the extent that such indemnification obligations apply to the lawsuits described in "Note 6. Commitments and Contingencies" in Part I, Item 1 of this Form 10-Q, any associated expenses incurred are included within the related accrued litigation expense amounts. No additional liability associated with such indemnification agreements has been recorded as of September 30, 2020.

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