REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) or (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Title of each class |
Trading Symbol |
Name of each exchange on which registered | ||
“ |
||||
|
* | |
☒ | Accelerated filer | ☐ | ||||
Non-accelerated file | ☐ | Emerging Growth Company |
U.S. GAAP ☐ |
by the International Accounting Standards Board ☒ |
Other ☐ |
PAGE |
||||||
2 |
||||||
3 |
||||||
Item 1. |
5 |
|||||
Item 2. |
5 |
|||||
Item 3. |
5 |
|||||
Item 4. |
58 |
|||||
Item 4A. |
112 |
|||||
Item 5. |
113 |
|||||
Item 6. |
139 |
|||||
Item 7. |
154 |
|||||
Item 8. |
162 |
|||||
Item 9. |
163 |
|||||
Item 10. |
163 |
|||||
Item 11. |
181 |
|||||
Item 12. |
182 |
|||||
Item 13. |
184 |
|||||
Item 14. |
184 |
|||||
Item 15. |
185 |
|||||
Item 16. |
185 |
|||||
Item 16A. |
185 |
|||||
Item 16B. |
185 |
|||||
Item 16C. |
186 |
|||||
Item 16D. |
186 |
|||||
Item 16E. |
186 |
|||||
Item 16F. |
187 |
|||||
Item 16G. |
187 |
|||||
Item 16H. |
187 |
|||||
Item 16I |
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections |
|||||
Item 17. |
188 |
|||||
Item 18. |
188 |
|||||
Item 19. |
188 |
• | the initiation, timing, progress and results of our pre-clinical and clinical studies, and our research and development programs; |
• | our ability to advance product candidates into, and successfully complete, clinical studies; |
• | the timing of regulatory filings and the likelihood of favorable regulatory outcomes and approvals; |
• | regulatory developments in the United States and the European Union and its member countries, and other countries; |
• | the commercialization of our product candidates, if approved; |
• | the pricing and reimbursement of our product candidates, if approved; |
• | the regulatory qualification and certification of our in-house manufacturing facilities and their manufacturing capabilities and operations; |
• | our ability to contract on commercially reasonable terms with CROs, third-party suppliers of biological raw or starting materials and manufacturers; |
• | the implementation of our business model, strategic plans for our business, product candidates and technology; |
• | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; |
• | the ability of third parties with whom we contract to successfully conduct, supervise and monitor clinical studies for our therapeutic product candidates; |
• | estimates of our expenses, future revenues, capital requirements and our needs for additional financing; |
• | our ability to obtain additional funding for operations; |
• | the potential benefits of our strategic licensing agreements with strategic licensees and our ability to enter into future strategic arrangements; |
• | the ability and willingness of strategic licensees pursuant to our strategic licensing agreements with strategic licensees to actively pursue development activities under our collaboration agreements; |
• | our receipt of milestone or royalty payments pursuant to our strategic licensing agreements with Allogene Therapeutics, Inc. (“Allogene”) and Les Laboratoires Servier (“Servier”); |
• | our ability to maintain and establish collaborations or obtain additional grant funding; |
• | the rate and degree of market acceptance of, and demand for, our product candidates; |
• | our status as a passive foreign investment company for U.S. federal income tax purposes; |
• | the financial performance and cash runway for our Therapeutics business; |
• | our ability to attract and retain key scientific and management personnel; |
• | our expectations regarding the period during which we qualify as a foreign private issuer; |
• | developments relating to our competitors and our industry, including competing therapies and technologies; |
• | Calyxt’s future financial performance, including its cash runway, and statements about Calyxt’s ability to continue as a going concern and Calyxt’s management’s plans to address Calyxt’s liquidity and capital resource needs; |
• | Calyxt’s product pipeline and development; Calyxt’s business model and strategies for the development, commercialization and sales of its commercial products; commercial demand for Calyxt’s synthetic biology solutions; the development and deployment of Calyxt’s PlantSpring technology platform; Calyxt’s ability to deploy and leverage its artificial intelligence and |
machine learning (AIML) capabilities; the ability to scale production capability for Calyxt’s BioFactory production system; potential development agreements, partnerships, customer relationships, and licensing arrangements and their contribution to Calyxt’s financial results, cash usage, and growth strategies; and |
• | the potential impact of the COVID-19 pandemic on our business and operating results; and anticipated trends in our business. |
ITEM 1. |
IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS |
ITEM 2. |
OFFER STATISTICS AND EXPECTED TIMETABLE |
ITEM 3. |
KEY INFORMATION |
A. |
[Reserved] |
B. |
Capitalization and Indebtedness |
C. |
Reasons for the Offer and Use of Proceeds |
D. |
Risk Factors |
• | Our operating history, which has focused primarily on research and development and advancing immunotherapy gene-editing clinical trials, makes it difficult to assess our future prospects. |
• | We have not generated significant revenues and have incurred significant operating losses since our inception. While the amount of our future net losses will depend, in part, on the amount of our future operating expenses and our ability to obtain funding, realize payments under our strategic licensing arrangements, and obtain reimbursements of research tax credit claims, we anticipate that we will continue to incur significant losses for the foreseeable future. |
• | We face substantial competition in our discovery, development and commercialization activities from competitors who may have significantly greater resources than we do. |
• | Because our product candidates all apply novel gene-editing technology, we are heavily dependent on the successful development of this technology. |
• | The extent to which the COVID-19 pandemic and resulting deterioration of worldwide economic conditions adversely impacts our business, financial condition, and operating results will depend on future developments, which are difficult to predict. |
• | We may need to raise additional funding, which may not be available on acceptable terms or at all, and our ability to raise additional share capital is limited by French corporate law. |
• | Our product candidates must undergo clinical trials that are time-consuming and expensive, the outcomes of which are unpredictable, and for which there is a high risk of failure, and which are susceptible under a variety of circumstances to additional costs, delays, suspensions and terminations. |
• | Initial, interim and preliminary data from our clinical trials may change as more data becomes available, and subsequent data may not bear out promising early results. |
• | Because we anticipate that our product candidates will initially receive regulatory approval as treatments for advanced disease or rare diseases, the size of the initial market for our product candidates may be limited. |
• | Our manufacturing process, which is highly complex and heavily regulated, may be difficult to efficiently and effectively operate and scale to the level required for advanced clinical trials or commercialization. |
• | Our manufacturing facilities may not obtain or maintain the required regulatory authorizations to supply commercial products. |
• | Acceptance and adoption of gene-editing and enrollment in our trials may be adversely affected by undesirable side effects, negative perceptions among the public or the medical community, or the inadequacy of payor coverage. |
• | Our future profitability depends, in part, on our ability to penetrate global markets, where we would be subject to additional regulatory burdens and other risks and uncertainties. |
• | We rely on third parties for certain aspects of our discovery, development, manufacturing and commercialization, if any, of our product candidates and issues relating to such third parties, or their activities, which could result in additional costs and delays and hinder our research, development and commercialization prospects. |
• | Strategic license relationships may not be successful, including as a result of failures by our strategic licensees to perform satisfactorily or to devote resources to advance product candidates under our arrangements with them. |
• | We may encounter difficulties in managing our development and expansion, including challenges associated with recruiting additional employees, managing our internal development efforts and improving our operational, financial and management controls. |
• | The risk of product liability claims is inherent in the development and commercialization of therapeutic products, and product liability or other lawsuits could divert management and financial resources, result in substantial liabilities and reduce the commercial potential of our product candidates. |
• | The buy-out mechanism in our collaboration agreement with Servier may prevent or delay a takeover attempt. |
• | Our business is governed by a rigorous, complex and evolving regulatory framework, including premarketing regulatory requirements, pricing, reimbursement and cost-containment regulations, and rigorous ongoing regulation of approved products. This regulatory framework results in significant compliance costs, makes the development and approval of our product candidates time intensive and unpredictable, and may reduce the ultimate economic value and prospects for our product candidates. |
• | A Fast Track, Breakthrough Therapy or Regenerative Medicine Advanced Therapy designation by the U.S. Food and Drug Administration, or FDA, or a Priority Medicines designation by the European Medicines Agency, or EMA, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive regulatory approval. |
• | Any regulatory compliance failures could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings. |
• | Because our commercial success depends, in part, on obtaining and maintaining proprietary rights to our and our licensors’ intellectual property, our ability to compete may decline if we fail to obtain protection for our products, product candidates, processes and technologies or do not adequately protect our intellectual property. |
• | Our competitive position may be adversely impacted as a result of a variety of factors, including potentially adverse determinations of complex legal and factual questions involved in patents and patent applications or insufficiently long patent lifespans in one or more jurisdictions where we obtain intellectual property protection. |
• | Because it is cost prohibitive to seek intellectual property protection on a global basis, our intellectual property protection in certain jurisdictions many not be as robust as in the United States, which may adversely impact our competitive position. |
• | Third parties may assert rights to inventions we develop or otherwise regard as our own. |
• | A dispute concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could harm our business. |
• | Our business could be harmed if we lose key management personnel or cannot attract and retain other qualified personnel. |
• | The rights of shareholders in companies subject to French corporate law differ in material respects from the rights of shareholders of corporations incorporated in the United States. |
• | Our By-laws and French corporate law contain provisions that may delay or discourage a takeover attempt. |
• | Our international operations may be exposed to foreign exchange risks, U.S. federal income tax risks, and additional risks, which may adversely affect our financial condition, results of operations and cash flows. |
• | If we are classified as a PFIC for 2022 or any future taxable year, there may be adverse U.S. federal income tax consequences to U.S. holders. |
• | As a foreign private issuer, we are exempt from a number of rules under the U.S. securities laws and the Nasdaq’s corporate governance standards. We expect to follow certain home country practices in relation to certain corporate governance matters, which may afford less protection than would be provided if we complied fully with the Nasdaq requirements. |
• | Holders of our ADSs do not directly hold our ordinary shares and may be subject to limitations on the transfer of their ADSs and certain voting and withdrawal rights of the underlying ordinary shares as well as limitations on their ability to exercise preferential subscription rights or receive share dividends. |
• | Share ownership is concentrated in the hands of our principal shareholders and management, who will continue to be able to exercise substantial influence. |
• | Calyxt’s ability to continue as a going concern will depend on its ability to obtain additional financing, which may not be available on acceptable terms or at all, and failure to obtain such financing may force Calyxt to delay, limit or terminate its operations. If financing is obtained through future equity offerings by Calyxt, we may experience substantial additional dilution and, in connection with our ownership level falling below 50%, we will lose certain rights under our stockholders agreement with Calyxt. |
• | Calyxt’s success depends on its ability to successfully deliver synthetic biology solutions, which will require significant resources in a highly competitive industry. Calyxt has limited operating history in this industry, and will faces challenges associated with allocating limited resources, raising capital. gaining customers and competing with companies with greater resources. |
• | For Calyxt to be successful, it must secure customer collaborations, efficiently price its offerings, and demonstrate its technical capabilities and ability for commercial scale production, which involves risks of failure inherent in the deployment of innovative and complex emerging technologies. |
• | As a result of our ownership level in Calyxt, we are exposed to the various other risks to which Calyxt is subject, including (i) additional business and operational risks associated with developing an emerging technology, Calyxt’s reliance on third parties for production and services, reliance on customers and licensees for development and commercialization efforts, and risks associated with outdoor agriculture; (ii) regulatory risks, including the navigation of ethical, legal and social concerns relating to genetically modified or edited plant cells, the complex and evolving regulatory framework, including uncertainty regarding foreign regulation, increasing regulation of hemp development activities, regulatory and compliance burdens under environmental, health and safety laws, (iii) intellectual property risks, including the corresponding risks described with respect to our intellectual property, and (iv) risk associated with attracting and maintaining key management personnel and protecting its data from cybersecurity attacks. |
• | Disruptions to, and delays in, the clinical trials for the product candidates that we are developing resulting from suspensions or delays in enrollment or difficulties in enrolling patients; increased patient withdrawals from, or restrictions imposed on, patients participating in, the clinical trials; diversion of healthcare resources away from the conduct of the clinical trials; or interruptions in data collection, monitoring and/or processing due to governmental restrictions imposed in response to the COVID-19 pandemic. |
• | Disruptions and delays to our research and development programs resulting from a shutdown of our laboratory facilities due to expanded governmental restrictions or illness among laboratory personnel as a result of COVID-19, increased absenteeism among scientific or laboratory employees, or delays with respect to raw material or starting material necessary for research and development activities. |
• | Delays with respect to operations at our manufacturing facilities resulting from increased, expanded or additional government restrictions in Paris, France or Raleigh, North Carolina, or as a result of supply chain disruptions affecting raw materials required for our manufacturing processes. |
• | Overall reduced operational productivity resulting from challenges associated with remote work arrangements, limited resources to employees, and increased cybersecurity risks as a result of remote access to our information systems. |
• | Constraints on financing opportunities resulting from dislocations in the capital markets, which may make it too costly or difficult for us to pursue public or private equity or debt financings on acceptable terms. |
• | conditions imposed by the FDA or any foreign regulatory authority regarding the scope or design of clinical trials; |
• | inability to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support initiation of clinical studies; |
• | delays in obtaining, or the inability to obtain, regulatory agency approval for the conduct of the clinical trials or required approvals from institutional review boards, or IRBs, or other reviewing entities at clinical sites selected for participation in our clinical trials; |
• | the identification of flaws in the design of a clinical trial; |
• | changes in regulatory requirements and guidance that necessitate amendments to clinical trial protocols; |
• | delays in sufficiently developing, characterizing or controlling manufacturing processes suitable for clinical trials; |
• | insufficient supply or deficient quality of the product candidates or other materials necessary to conduct the clinical trials, including as a result of manufacturing issues at our in-house manufacturing facilities; ; |
• | difficulty in sourcing healthy donor material of sufficient quality and in sufficient quantity to meet our development needs; |
• | lower-than-anticipated enrollment and retention rate of subjects in clinical trials for a variety of reasons, including size of patient population, sites selection, nature of trial protocol, the availability of approved effective treatments for the relevant disease and competition from other clinical trial programs for similar indications and competition from approved products; |
• | delays in reaching agreement on acceptable terms with prospective contract research organizations (CROs) and clinical study sites and obtaining required institutional review board (IRB) approval at each clinical study site; |
• | the placing of a clinical hold on our strategic licensees’ clinical trials—for example, clinical holds were placed on our AMELI-01 Study in September 2018 and on our MELANI-01 Study in July 2020 and on all of our strategic licensee Allogene’s AlloCAR T clinical trials in October 2021 and remained in place until the FDA permitted these trials to restart in November 2018, November 2020 and January 2022, respectively; |
• | unfavorable interpretations by FDA or similar foreign regulatory authorities of interim data; |
• | determinations by the FDA or similar foreign regulatory authorities that a clinical trial protocol is deficient in design to meet its stated objectives; |
• | failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols; |
• | serious and unexpected safety issues, including drug-related side effects experienced by patients in clinical trials; |
• | failure of our or our strategic licensees’ third-party contractors to meet their contractual obligations in a timely manner; or |
• | lack of, or failure to, demonstrate efficacy of our products candidate. |
• | severity of the disease under investigation; |
• | incidence and prevalence of the disease under investigation; |
• | design of the clinical trial protocol; |
• | size and nature of the patient population; |
• | eligibility criteria for the trial in question; |
• | perceived risks and benefits of the product candidate under trial, including relative to other available therapies; |
• | proximity and availability of clinical trial sites for prospective patients; |
• | availability of competing therapies and clinical trials; |
• | patient referral practices of physicians; |
• | our ability to monitor patients adequately during and after treatment, and |
• | ability of the clinical sites to have sufficient resources and avoid any backlogs. |
• | failing to receive regulatory approvals required to market them as drugs; |
• | being subject to proprietary rights held by others; |
• | failing to comply with GMP requirements; |
• | being difficult or expensive to manufacture on a commercial scale; |
• | having adverse side effects that make their use less desirable; |
• | being inferior to existing approved drugs or therapies; |
• | failing to compete effectively with existing or new products or treatments commercialized by competitors; or |
• | failing to show long-term benefits sufficient to offset associated risks. |
• | the clinical indications for which product candidates are approved; |
• | the potential and perceived advantages and risks of our product candidates relative to alternative treatments; |
• | the prevalence and severity of side effects; |
• | the demonstration of the clinical efficacy and safety of the product; |
• | the approved labeling for the product and any required limitations or warnings; |
• | the timing of market introduction of the product candidate as well as of competing products; |
• | the effectiveness of educational outreach to the medical community about the product; |
• | the coverage and reimbursement policies of government and commercial third-party payors pertaining to the product; and |
• | the market price of the product relative to competing treatments. |
• | a covered benefit under applicable policies or plans; |
• | safe, effective and medically necessary; |
• | appropriate for the specific patient; |
• | cost-effective; and |
• | neither experimental nor investigational. |
• | obtaining, on a country-by-country |
• | the burden of complying with complex and changing regulatory, tax, accounting and legal requirements in each jurisdiction that we pursue; |
• | differing medical practices and customs affecting acceptance in the marketplace; |
• | import or export licensing requirements; |
• | country specific requirements related to the cells used as starting material for manufacturing; |
• | language barriers for technical training, healthcare professionals and patients documents; |
• | reduced protection of intellectual property rights in some foreign countries; |
• | foreign currency exchange rate fluctuations; |
• | potential imposition of governmental controls; and |
• | patients’ ability to obtain reimbursement for products in various markets. |
• | that we may be unable to negotiate agreements with third parties under reasonable terms or that termination or non-renewal of an agreement occurs in a manner or time that is costly or damaging to us; |
• | that such third-parties may have limited experience with our or comparable products and may require significant support from us in order to implement and maintain the infrastructure and processes required to manufacture, test or distribute our product candidates; |
• | that such third parties may not perform as agreed or in compliance with applicable laws and requirements, or may not devote sufficient resources to our products; |
• | that we may not have sufficient rights or access to the intellectual property or know how relating to improvements or developments made by our third-party service providers in the course of their providing services to us; |
• | that regulators object to or disallow the performance of specific tasks by certain third parties or disallow data provided by such third parties; |
• | that such third parties may experience business disruptions, such as bankruptcy or acquisition, or failures or deficiencies in their supply chains, that disrupt their ability to perform their obligations to us. |
• | strategic licensees may not perform or prioritize their obligations as expected; |
• | clinical trials conducted pursuant to strategic licensing agreements may not be successful; |
• | strategic licensees may not pursue development and commercialization of product candidates that achieve regulatory approval or may elect not to pursue development or commercialization of product candidates based on clinical trial results, changes in the partners’ focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities; |
• | strategic licensees may delay clinical trials, provide insufficient funding for clinical trials, stop a clinical trial, or abandon a product candidate; |
• | strategic licensees could develop, independently or with third parties, products that compete directly or indirectly with our product candidates; |
• | product candidates developed pursuant to strategic licensing agreements may be viewed by our partners as competitive with their independently developed product candidates or products, which may cause them to devote limited resources to the product candidate’s development or commercialization; |
• | a collaborator may not commit sufficient resources to the commercialization, marketing and distribution of any product candidate; |
• | disagreements with strategic licensees, including over proprietary rights, contract interpretation, or the preferred course of development, may cause delays or termination of the development or commercialization of such product candidates, or may result in time- consuming and expensive legal proceedings; |
• | strategic licensees may not properly obtain, maintain, protect, defend or enforce intellectual property rights or may improperly use proprietary information; |
• | disputes may arise with respect to the ownership of intellectual property developed pursuant to our strategic licensing agreements; |
• | strategic licensees may infringe, misappropriate or otherwise violate third-party intellectual property rights, which may expose us to litigation and potential liability; |
• | strategic licensing agreements may be terminated for convenience by the collaborator and, if terminated, the development of product candidates may be delayed or stopped; |
• | the negotiation of strategic licensing agreements may require substantial attention from our management team; and |
• | we could face significant competition in seeking appropriate strategic licensees, and the negotiation process is time-consuming and complex. |
• | our inability to exercise direct control over sales, distribution and marketing activities and personnel; |
• | potential failure or inability of contracted sales personnel to successfully market our products to physicians; |
• | potential disputes with third parties concerning distribution, sales and marketing expenses, calculation of royalties, and sales and marketing strategies. |
• | identifying, recruiting, integrating, maintaining and motivating additional employees; |
• | effectively managing our internal development efforts, including the clinical and regulatory review process for our product candidates; and |
• | improving our operational, financial and management controls, reporting systems and procedures. |
• | issue a warning letter asserting a violation of the law; |
• | seek an injunction or impose civil or criminal penalties or monetary fines; |
• | suspend or withdraw regulatory approval; |
• | suspend or terminate any ongoing clinical trials; |
• | refuse to approve a pending BLA or comparable foreign marketing application (or any supplements thereto) submitted by us or our strategic licensees; |
• | restrict the marketing, distribution or manufacturing of the product; |
• | seize or detain product or otherwise require the withdrawal or recall of product from the market; |
• | destroy or require destruction of products; |
• | refuse to permit the import or export of products; or |
• | refuse to allow us to enter into supply contracts, including government contracts. |
• | their biological medicine is highly similar to the reference medicine, notwithstanding natural variability inherent to all biological medicines; and |
• | there are no clinically meaningful differences between the biosimilar and the reference medicine in terms of safety, quality and efficacy. |
• | the second applicant can establish that its product, although similar to the orphan medicinal product already authorized, is safer, more effective or otherwise clinically superior; |
• | the holder of the marketing authorization of the orphan medicinal product consents to a second orphan medicinal product application; or |
• | the holder of the marketing authorization of the orphan medicinal product cannot supply sufficient quantities of the orphan medicinal product. |
• | The federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase or lease, order or recommendation of, any item, good, facility or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid. |
• | The federal civil and criminal false claims laws and civil monetary penalties laws, which impose criminal and civil penalties, including those from civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, claims for payment that are false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government. |
• | The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program or knowingly and willingly falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters. |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which impose certain requirements on covered entities and their business associates, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. |
• | The federal transparency requirements under the Physician Payments Sunshine Act, enacted as part of the ACA, that require applicable manufacturers of covered drugs, devices, biologics and medical supplies to track and annually report to CMS payments and other transfers of value provided to physicians and teaching hospitals and certain ownership and investment interests held by physicians or their immediate family members. |
• | Analogous laws and regulations in various U.S. states, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers, state marketing and/or transparency laws applicable to manufacturers that may be broader in scope than U.S. federal requirements, state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. government, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect as HIPAA. |
• | the right to nominate a number of designees for Calyxt’s board of directors representing a majority of the directors, to designate the Chairman of the board of directors and to have at least one designated director serve on each board committee; |
• | information rights with respect to Calyxt; |
• | approval of certain changes to Calyxt’s constitutive documents; |
• | approval of Calyxt’s making of any regular or special dividends; |
• | approval of Calyxt’s commencement of any voluntary bankruptcy proceeding or any consent to any bankruptcy proceeding; |
• | approval of any appointment to or removal from the Calyxt board of directors; and |
• | approval of the consummation of any public or private offering, merger, amalgamation or consolidation of Calyxt, the spinoff of a business of Calyxt, or any sale, conveyance, transfer or other disposition of Calyxt’s assets. |
• | Adverse weather conditions, natural disasters, crop disease, pests and other natural conditions; |
• | Climate change that may cause changes in weather patterns and conditions, including changes in rainfall and storm patterns and intensities, water shortages, changes in sea levels, and changes in temperature levels; |
• | Licensee field trials may be unsuccessful; |
• | Licensee products, and food containing those products, may fail to meet standards established by third-party non-GMO verification organizations; |
• | The unintended presence of Calyxt’s traits in other products or plants may have a negative effect on the licensee’s operations. |
• | a failure to achieve commercial traction with Calyxt’s target customers; |
• | loss of customer contracts or delays in fulfilling Calyxt’s contractual obligations; |
• | damage to Calyxt’s brand reputation; |
• | product recalls or replacements; |
• | inability to attract new customers and collaboration opportunities; |
• | diversion of resources from Calyxt’s R&D and sales activities; and |
• | legal and regulatory claims against Calyxt, including product liability claims, which could be costly, time consuming to defend, result in substantial damages and result in reputational damage. |
• | we or our licensors may not have been the first to invent the technology covered by our or their pending patent applications or issued patents; |
• | we cannot be certain that we or our licensors were the first to file patent applications covering our product candidates, including their compositions or methods of use, as patent applications in the United States and most other countries are confidential for a period of time after filing; |
• | others may independently develop identical, similar or alternative products or compositions or methods of use thereof; |
• | the disclosures in our or our licensors’ patent applications may not be sufficient to meet the statutory requirements for patentability and the plausibility case law requirements that may exist in certain jurisdictions; |
• | any or all of our or our licensors’ pending patent applications may not result in issued patents; |
• | we or our licensors may not seek or obtain patent protection in countries or jurisdictions that may eventually provide us a significant business opportunity; |
• | any patents issued to us or our licensors may not provide a basis for commercially viable products, may not provide any competitive advantages, or may be successfully challenged by third parties, which may result in our or our licensors’ patent claims being narrowed, invalidated or held unenforceable; |
• | our compositions and methods may not be patentable; |
• | others may design around our or our licensors’ patent claims to produce competitive products that fall outside of the scope of our or our licensors’ patents; and |
• | others may identify prior art or other bases upon which to challenge and ultimately invalidate our or our licensors’ patents or otherwise render them unenforceable. |