TORONTO, July 24, 2020 /CNW/ - Roots ("Roots," "Roots Canada" or the "Company") (TSX: ROOT), a premium-outdoor lifestyle brand, today announced the results of voting at its Fiscal 2019 Annual and Special Meeting of Shareholders held earlier today (the "Meeting"). Each of the matters voted upon at the Meeting as set out below is described in greater detail in the Notice of Annual and Special Meeting of Shareholders and Management Information Circular of Roots dated June 18, 2020.
The total number of shares represented by holders by proxy at the Meeting was 21,241,989, representing approximately 50.43% of Roots outstanding shares entitled to be voted.
Election of DirectorsAll of the nominees listed in the management information circular prepared in connection with the Meeting were elected as directors by a resolution passed by a majority of the shareholders present or represented by proxy at the Meeting, to hold office until the next annual meeting following their election or until their successors are elected or appointed, without a ballot being conducted. The following represents the proxies received with regard to such matter:
% Votes For
% Votes Withheld
Mary Ann Curran
Dale H. Lastman, C.M.
Richard P. Mavrinac
Appointment of AuditorsKPMG LLP was reappointed as auditor of Roots and the directors were authorized to fix the auditor's remuneration by a resolution passed by a majority of the shareholders present or represented by proxy at the Meeting without a ballot being conducted. The following represents the proxies received with regard to such matter:
% Votes For
% Votes Withheld
Amendment to Omnibus Equity Incentive PlanThe adoption of the amendment to Roots omnibus equity incentive plan was approved by a resolution passed by a majority of the shareholders present or represented by proxy at the Meeting without a ballot being conducted. As a result, the total number of common shares available for issuance under the omnibus equity incentive plan has increased from 1,679,220 common shares to 3,679,220 common shares. The following represents the proxies received with regard to such matter:
% Votes For
% Votes Against
About RootsEstablished in 1973, Roots is a premium outdoor-lifestyle brand. We unite the best of cabin and city through unmistakable style built with uncompromising comfort and quality. We offer a broad range of products designed for life's everyday adventures, including: women's and men's apparel, leather goods, footwear, accessories, and kids, toddler and baby apparel. Starting from a little cabin in Algonquin Park, Canada, Roots has grown to become a global brand. As of May 2, 2020, we operated 114 corporate-retail stores in Canada, two corporate-retail stores in the United States, 115 partner-operated stores in Taiwan, 37 partner-operated stores in China, two partner-operated stores in Hong Kong and a global eCommerce platform, roots.com. Roots Corporation is a Canadian corporation doing business as "Roots" and "Roots Canada".
SOURCE Roots Corporation
SAN FRANCISCO, Oct. 21, 2020 /PRNewswire/ -- IIDA Northern California, the professional association for the region's commercial interior designers, is grappling with how today's monumental issues affect our work and public spaces. The COVID-19 pandemic, racial justice and climate change have major implications for how to make commercial spaces safe, functionally efficient and aesthetically rich.
"At IIDA, we believe commercial interior design plays a key role in promoting the health, safety and welfare of the public. Design has the power to heal and bring people together," said Yoko Ishihara, president of IIDA Northern California. "In respect to public health, racial equity and climate change, these are unprecedented times. As highly trained professionals, we're responsible for pushing the value of design beyond our current understanding to make a positive transformation through innovation."
Commercial interior designers are trained to identify and apply creative and technical design solutions to the interiors of commercial buildings – from offices and hospitals to restaurants and concert halls. Their goal is to understand the human experience within these spaces, and improve how people use them, all while keeping the public safe and healthy. Their work must conform to local and state codes which these professionals must understand and follow thoroughly to ensure compliance.
The advent of COVID: A new design challengeThe COVID-19 pandemic has presented new challenges to commercial interior designers. They must now address how commercial building design can help mitigate the spread of infectious diseases and balance that with the economics of managing a business. Factors being reassessed include how to move people to and through workspaces; how to keep interior surfaces clean with minimal human touchpoints; air quality, filtration and freshness; and how to balance health-driven spatial requirements with ambience and experience in hospitality spaces such as hotels, restaurants or entertainment venues.
Designing for safety and healthHealth and wellness decisions are supported by material choices, physical design and aesthetics. Considerations include lighting, ventilation, water filtration and climate control. The pandemic adds per-person space allocation, navigation patterns and shared touchable surfaces to this list. Strictly clinical considerations must be translated for the varied usages of commercial spaces.
"People visit restaurants for cultural experiences and to be part of a community," says Ishihara, who also is a principal at Wilson Ishihara in San Francisco. "The space has to feel hospitable – not hospital-like. Within the context of a pandemic, we must focus on maximizing diner experiences – how it feels to sit at every table and adjust spaces so customers feel safe while the experiences are still meaningful and delightful. This will ensure that customers return and will safeguard the long-term health of the business."
Designing for changing work patterns The pandemic has moved many to work from home and the very nature of work has shifted in likely enduring ways. According to researcher Jennifer Magnolfi Astill, "The pandemic will mark a permanent change in our perception of workspace. New ways of working together will emerge. Innovation will first appear with digital work tools and later with physical space."
With many companies delaying a return to their offices, Northern California commercial interior designers are already generating possible solutions for both short- and long-term needs of the new work dynamic. San Francisco-based design firm RMW modelled its New Office Paradigm on the assumption that shared workspace is vital for team collaboration and creativity, even while maintaining physical distancing and hygienic practices.
Designing for flexibility and sustainabilityCommercial interior designers are experts in understanding the required quality and durability of materials selected to meet the projected needs, resources and usage of the space. Flexibility is critical to address this rapid transformation of usage.
For a new shared laboratory facility that houses biotech start-ups actively researching COVID-related solutions, the design team at MBH Architects of Alameda, Calif. reworked large common spaces into seating areas that offer numerous options and are completely changeable. The designers' deep relationship with furnishings vendors yielded the "energizing" colors the client sought, while also meeting the health needs requiring non-porous, completely cleanable surfaces.
Promoting a healthy environment and mitigating the impact of climate change are growing worldwide concerns. Regulations, clients and the public are demanding that commercial buildings be built using environmentally sensitive materials and practices, and that buildings function in a sustainable way. With some of the strictest and most progressive building codes in the nation, Northern California's commercial interior designers are increasingly applying LEED certification and WELL building standards to create "healthy buildings" for all.
Designing for equitable human experienceGood interior design has the power to positively influence people. It helps both buildings and their occupants function more efficiently, sustainably and safely. This diverse population includes different ages, physical and intellectual capabilities, cultural backgrounds and preferences.
CEO of IIDA's national organization, Cheryl Durst, recently wrote, "Confronting racism, injustice and a need for equity is critical to moving forward….We know that design is but one small part of that larger equation - so why not start with the change we can most immediately affect?"
IIDA Northern California recently launched a major initiative, Dignity, Equity and Justice by Design. This program includes conversations, community outreach and mentorship programs. It is designed to galvanize action among IIDA members that can lead to the change that Durst and Ishihara envision.
About IIDAFounded in 1994, the International Interior Design Association (IIDA) of Northern California is a not-for-profit philanthropic organization that represents more than 900 commercial interior designers from Silicon Valley to Sacramento, San Francisco to Fresno. Like that of its national organization, IIDA NorCal's mission is to support and promote the profession through education, sharing knowledge and best practices, advocacy and research. The work of commercial interior designers touches the health, safety and well-being of millions of people every day. For more information, please visit www.iidanc.org.
David Cumpston, Landis Communications Inc.IIDA@landispr.com | (415) 902-4461 | www.landispr.com
View original content:https://www.prnewswire.com/news-releases/commercial-interior-designers-are-driving-innovation-for-workplace-safety-health-and-equity-during-a-time-of-pandemic-and-civil-rights-activism-301157315.html
SOURCE IIDA Northern California
The CEOs of AstraZeneca (LSE/STO/NYSE: AZN), BioNTech (NASDAQ: BNTX), GlaxoSmithKline plc (LSE/NYSE: GSK), Johnson & Johnson (NYSE: JNJ), Merck (NYSE: MRK), known as MSD outside the United States and Canada, Moderna, Inc. (Nasdaq: MRNA), Novavax, Inc. (Nasdaq: NVAX), Pfizer Inc. (NYSE: PFE), and Sanofi (NASDAQ: SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200908005282/en/
All nine CEOs signed the following pledge:We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.
The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.
Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:
Always make the safety and well-being of vaccinated individuals our top priority.
Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.
For more information, please visit https://biontech.de/.
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.
About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at Learn more at www.jnj.com. Follow us at @JNJNews.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.
Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal or www.twitter.com/JanssenUS.
For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.
Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.
For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
For further information, please visit www.sanofi.com
Forward Looking Statements of BioNTech
This press release contains "forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning BioNTech’s efforts to combat COVID-19. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: competition to create a vaccine for COVID-19; the ability to produce comparable clinical results in larger and more diverse clinical trials; the ability to effectively scale our productions capabilities; and other potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.
GSK Cautionary Statement Regarding Forward-Looking Statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK’s "Principal risks and uncertainties” section of the Q2 Results and any impacts of the COVID-19 pandemic.
Forward-Looking Statement of the Janssen Pharmaceutical Companies of Johnson & Johnson
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company”) includes "forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2019 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Forward-Looking Statement of Moderna, Inc., Cambridge, MA, USA
This news release of Moderna, Inc. ("Moderna”) contains "forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, as amended, including but not limited to: statements regarding the conduct of clinical trials for Moderna’s vaccine candidate against COVID-19 ("mRNA-1273”), the process for obtaining regulatory approval for mRNA-1273 in the United States and other jurisdictions, and the global supply of mRNA-1273. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. These risks, uncertainties, and other factors include, among others: no commercial product using mRNA technology has been approved, and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with Moderna’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; and those risks and uncertainties described under the heading "Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.
Forward-Looking Statements of Novavax
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Pfizer Disclosure Notice
The information contained in this release is as of September , 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer’s efforts to combat COVID-19 and the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary data, including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from current and future preclinical and clinical studies; whether and when any biologics license and/or emergency use authorization applications may be filed in any jurisdictions for any potential vaccine candidates; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine candidate’s benefits outweigh its known risks and determination of the vaccine candidate’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; manufacturing capabilities or capacity, including whether the estimated numbers of doses can be manufactured within the projected time periods; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors” and "Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
Forward Looking Statement of Sanofi
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects”, "anticipates”, "believes”, "intends”, "estimates”, "plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors” and "Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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