3 unchanged sentences
37-2019-00066358-CU-PO-CTL.
−Removed: The lawsuit alleges sexual assault by an acquaintance of one of our employees and seeks to hold the Company liable on a number of causes of action.
−Removed: On January 17, 2020, a second amended complaint (“SAC”) was filed seeking $30.0 million in damages, including punitive damages and damages for emotional distress.
+Added: The lawsuit alleges sexual assault by
+Added: an acquaintance of one of our employees and seeks to hold the Company liable on a number of causes of action.
+Added: On January 17, 2020, a second amended complaint (“SAC”) was filed seeking $30.0 million in damages, including punitive damages and damages for
+Added: emotional distress.
The plaintiff has agreed to stipulate to arbitration for the claims being alleged against the Company.
−Removed: The Company believes the allegations of Ms.
−Removed: Munoz against the Company in her complaint are without merit, and intends to vigorously defend itself in the foregoing action.
+Added: believes the allegations of Ms.
+Added: Munoz against the Company in her complaint are without merit, and intends to vigorously defend itself
+Added: in the foregoing action.
However, in light of the preliminary stage of the litigation, the Company is unable to estimate a potential loss or range of losses relating to this matter.
−Removed: Risk Factors.
−Removed: Our business is subject to various risks, including those described in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which we strongly encourage you to review.
−Removed: Other than as set forth below, there have been no material changes to the risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 16, 2020.
−Removed: Our pursuit of a COVID-19 vaccine candidate is at an early stage.
−Removed: We may be unable to produce a vaccine that successfully prevents infection from the virus in a timely manner, if at all, and preliminary data may not be indicative of future success.
−Removed: In response to the global outbreak of coronavirus, in March 2020, we entered into a partnership with Duke-NUS Medical School in Singapore to develop a novel coronavirus (COVID-19) vaccine for Singapore.
−Removed: Our development of the vaccine is in early stages, and we may be unable to produce a vaccine that successfully prevents infection from the virus in a timely manner, if at all.
−Removed: We are also committing financial resources and personnel to the development of a COVID-19 vaccine which may cause delays in or otherwise negatively impact our other development programs, despite uncertainties surrounding the longevity and extent of coronavirus as a global health concern.
−Removed: Our business could be negatively impacted by our allocation of significant resources to a global health threat that is unpredictable and could rapidly dissipate or against which our vaccine, if developed, may not be partially or fully effective.
−Removed: In addition, a substantial number of companies, individuals and institutions are working to develop a vaccine, many of which have substantially greater financial, scientific and other resources than us, and another party may be successful in producing a more efficacious vaccine or other treatment for COVID-19 which may also lead to the diversion of governmental and quasi-governmental funding away from us and toward other companies, and lead to demand being driven away from our product, even if developed.
−Removed: Finally, even though we may report preliminary pre-clinical or other data that could appear to be positive, no assurance can be given that any product candidate will be safe in humans or prove to be effective once trials commence.
−Removed: We will not be able to commercialize or market the product candidate unless and until we are able to demonstrate that our vaccine candidate is safe and effective in humans.
−Removed: It is possible that one or more government entities may take actions that directly or indirectly have a negative effect on our opportunities.
−Removed: If we were to develop a COVID-19 vaccine, the economic value of such a vaccine to us could be limited.
−Removed: Various government entities, including the U.S.
−Removed: government, are offering incentives, grants and contracts to encourage additional investment by commercial organizations into preventative and therapeutic agents against coronavirus, which may have the effect of increasing the number of competitors and/or providing advantages to known competitors.
−Removed: Accordingly, there can be no assurance that we will be able to successfully establish a competitive market share for our COVID-19 vaccine, if any.
−Removed: The recent coronavirus outbreak has caused interruptions or delays of our business plan and may have a significant adverse effect on our business.
−Removed: In December 2019, a strain of coronavirus, COVID-19, was reported to have surfaced in Wuhan, China, and on March 12, 2020, the World Health Organization declared COVID-19 to be a pandemic.
−Removed: In an effort to contain and mitigate the spread of COVID-19, many countries, including the United States, Canada and China, have imposed unprecedented restrictions on travel, quarantines, and other public health safety measures.
−Removed: The extent to which the pandemic may impact our business will depend on future developments, which are highly uncertain and cannot be predicted, but the development of clinical supply materials could be delayed and enrollment of patients in our study for LUNAR-OTC and LUNAR-COV19 may be delayed or suspended, as hospitals and clinics in areas where we are conducting trials shift resources to cope with the COVID-19 pandemic and may limit access or close clinical facilities due to the COVID-19 pandemic.
−Removed: Additionally, if our trial participants are unable to travel to our clinical study sites as a result of quarantines or other restrictions resulting from the COVID-19 pandemic, we may experience higher drop-out rates or delays in our clinical studies.
−Removed: Government-imposed quarantines and restri ctions may also require us to temporarily terminate our clinical sites.
−Removed: Furthermore, if we determine that our trial participants may suffer from exposure to COVID-19 as a result of their participation in our clinical trials, we may voluntarily terminate ce rtain clinical sites as a safety measure until we reasonably believe that the likelihood of exposure has subsided.
−Removed: As a result, our expected development timelines for our product candidates may be negatively impacted.
−Removed: We cannot predict the ultimate impact of the COVID-19 pandemic as consequences of such an event are highly uncertain and subject to change.
−Removed: We do not yet know the full extent of potential delays or impacts on our business, our clinical studies or as a whole;
−Removed: however, the COVID-19 outbreak may materially disrupt or delay our business operations, further divert the attention and efforts of the medical community to coping with COVID-19, disrupt the marketplace in which we operate, and/or have a material adverse effect on our operations.
−Removed: Moreover, the various precautionary measures taken by many governmental authorities around the world in order to limit the spread of the coronavirus has had and may continue to have an adverse effect on the global markets and global economy generally, including on the availability and pricing of employees, resources, materials, manufacturing and delivery efforts and other aspects of the global economy.
−Removed: There have been business closures and a substantial reduction in economic activity in countries that have had significant outbreaks of COVID-19.
−Removed: Significant uncertainty remains as to the potential impact of the COVID-19 pandemic on the global economy as a whole.
−Removed: It is currently not possible to predict how long the pandemic will last or the time that it will take for economic activity to return to prior levels.
−Removed: The COVID-19 pandemic could materially disrupt our business and operations, interrupt our sources of supply, hamper our ability to raise additional funds or sell or securities, continue to slow down the overall economy or curtail consumer spending.
−Removed: We intend to conduct foreign clinical trials (FCT) only for our pending COVID-19 vaccine.
−Removed: While costs of FCTs are significantly lower than the costs of an equivalent trial in the United States, there are risks associated with FCTs which may ultimately inhibit FDA approval.
−Removed: Costs associated with FCTs are significantly lower than the costs of equivalent trials in the United States.
−Removed: However, any clinical data from the FCT may not be adequate to support FDA approval without further preclinical studies, clinical trials, or both.
−Removed: Other companies have in the past encountered various problems with FCTs.
−Removed: The occurrence of any of these could have a material adverse effect on the ultimate path to FDA approval of any COVID-19 vaccine we may develop, which may negatively impact our financial condition and our business.
−Removed: Unregistered Sales of Equity Securities and Use of Proceeds.
−Removed: Defaults Upon Senior Securities.
−Removed: Mine Safety Disclosures.
−Removed: Not applicable.
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.