Tg Therapeutics, Inc 10-K for FY2024

Tg Therapeutics, Inc. (TGTX)

10-K 2025-03-03 For: 2024-12-31

Added on April 09, 2026

About this 10-K

Tg Therapeutics, Inc filed this 10-K on March 3, 2025, covering the fiscal year ended December 31, 2024 (FY2024).

Headline figures

Fiscal year ended December 31, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $329M; up 40.8% from $233.66M a year earlier
Net income: $23.38M; up 84.5% from net income of $12.67M a year earlier
Diluted EPS: $0.15; up 66.7% from $0.09 a year earlier

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Delaware	36-3898269
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)

3020 Carrington Mill Blvd, Suite 475
Morrisville, North Carolina	27560
(Address of principal executive offices)	(Zip Code)

Title of Class	Trading Symbol(s)	Exchange Name
Common Stock, par value $0.001	TGTX	Nasdaq Capital Market

Large accelerated filer ☒	Accelerated filer ☐
Non-accelerated filer ☐	Smaller reporting company ☐
	Emerging growth company ☐

		Page
SPECIAL CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS		2
SUMMARY RISK FACTORS		3

PART I		5

ITEM 1	Business	5
ITEM 1A	Risk Factors	24
ITEM 1B	Unresolved Staff Comments	74
ITEM 1C	Cybersecurity	74
ITEM 2	Properties	75
ITEM 3	Legal Proceedings	75
ITEM 4	Mine Safety Disclosures	75

PART II		76

ITEM 5	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	76
ITEM 6	Removed and Reserved	78
ITEM 7	Management’s Discussion and Analysis of Financial Condition and Results of Operations	79
ITEM 7A	Quantitative and Qualitative Disclosure About Market Risk	89
ITEM 8	Financial Statements and Supplementary Data	89
ITEM 9	Changes in and Disagreements With Accountants on Accounting and Financial Disclosures	89
ITEM 9A	Controls and Procedures	90
ITEM 9B	Other Information	91

PART III		92

ITEM 10	Directors, Executive Officers and Corporate Governance	92
ITEM 11	Executive Compensation	92
ITEM 12	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	92
ITEM 13	Certain Relationships and Related Transactions, and Director Independence	92
ITEM 14	Principal Accounting Fees and Services	92

PART IV		93

ITEM 15	Exhibits and Financial Statement Schedules	93

●	our ability to advance drug candidates into, and successfully complete, clinical trials;
●	our ability to develop, formulate, manufacture and commercialize our product candidates;

●	our financial performance and cash burn management;
●	our ability to maintain or obtain adequate product liability and other insurance coverage;

●	developments relating to our competitors and our industry;
●	the effects on our company of future regulatory developments or legislative actions, including changes in healthcare, environmental and other laws and regulations to which we are subject;
●	prevailing economic, market and business conditions;
●	our ability to retain, attract and hire key personnel;
●	our competitive position;
●	fluctuations in the trading price of our common stock;
●	our use of cash and other resources; and
●	our ability to successfully implement our strategy.

●	If we obtain U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approval for a product candidate and do not achieve broad market acceptance among physicians, patients, healthcare payors, and the medical community, the revenues that we generate from product sales will be limited.
●	We may be subject to limitations on the indicated uses or requirements to fulfill certain post-marketing requirements to the satisfaction of regulatory authorities or may be unable to maintain marketing approval for BRIUMVI or future products that we may bring to market.
●	BRIUMVI, and any of our product candidates for which we in the future obtain approval, may, after approval, be found to cause undesirable side effects that could result in significant negative consequences following commercialization.
●	The incidence and prevalence for target patient populations of BRIUMVI and our product candidates, including azer-cel in non-oncology indications, have not been established with precision. If the market opportunities for BRIUMVI and our product candidates are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability will be adversely affected.
●	We face substantial competition, which may result in others commercializing drugs before or more successfully than we do, resulting in the reduction or elimination of our commercial opportunity.
●	Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any drug candidates that we may develop.

●	While we have recently generated net income, we have incurred significant operating losses since our inception, and we may incur losses in the future.
●	While we do not expect to need to raise additional capital, we may need to do so. If we are unable to raise capital, if needed, we may be required to delay, limit, reduce or eliminate some of our drug development programs or commercialization efforts.
●	Our level of indebtedness and debt service obligations could adversely affect our financial condition and may make it more difficult for us to fund our operations.

●	If we are unable to maintain or obtain regulatory approval for our product and product candidates and ultimately cannot successfully commercialize our product or product candidates, or experience significant delays in doing so, our business will be materially harmed.
●	Because results of preclinical studies and early clinical trials are not necessarily predictive of future results, any product candidate we advance may not have favorable results in later clinical trials or receive regulatory approval. Moreover, interim, “top-line,” and preliminary data from our clinical trials that we announce or publish may change, or the perceived product profile may be negatively impacted, as more patient data or additional endpoints (including efficacy and safety) are analyzed.
●	Our product or product candidates may cause undesirable side effects that could delay or prevent their regulatory approval or impact their availability and commercial potential after approval.
●	Any products or product candidates we may advance through clinical development are subject to extensive regulation, which can be costly and time consuming, cause unanticipated delays or prevent the receipt of the required approvals.

●	We are subject to new legislation, regulatory proposals and third-party payor initiatives that may increase our costs of compliance and adversely affect our ability to market our products, obtain collaborators and raise capital.
●	If we fail to comply with various healthcare laws and regulations, we may incur losses or be subject to liability.
●	Inadequate funding for the FDA, the SEC or other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
●	If we fail to adequately understand and comply with the local laws and customs as we expand into new international markets, these operations may incur losses or otherwise adversely affect our business and results of operations.
●	Any product for which we obtain marketing approval, including BRIUMVI, could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with products.
●	The U.S. political and economic environment could materially impact our business operations and financial performance, and uncertainty surrounding the potential legal, regulatory and policy changes by a new U.S. presidential administration may directly affect us and the global economy.

●	We rely on third parties to generate clinical, preclinical and other data necessary to support the regulatory applications needed to conduct clinical trials and submit for marketing approval. We rely on third parties to help conduct our planned clinical trials. If these third parties do not perform their services as required, we may not be able to obtain regulatory approval for or commercialize our product or product candidates when expected or at all.
●	We contract with third parties for the manufacture and testing of BRIUMVI for commercial supply, as well as all of our clinical product supply, and we expect to continue to do so. This reliance on third parties increases the risk that we will not have sufficient quantities of our products or product candidates or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.
●	The third parties upon whom we rely for the supply of starting materials, intermediates, active pharmaceutical ingredient (API)/drug substance, drug product, and other materials used in our drug candidates are our sole source of supply, and the loss or disruption of any of these suppliers could significantly harm our business.
●	Because we have in-licensed BRIUMVI and our product candidates from third parties, any dispute with or non-performance by our licensors will adversely affect our ability to develop and commercialize the applicable product or product candidate.
●	We are dependent upon our relationships with collaboration and commercialization partners to further develop, fund, manufacture and commercialize our drug products and our product candidates. If such relationships are unsuccessful, or if a collaboration or commercialization partner terminates its collaboration or commercialization agreement with us, it could negatively impact our ability to conduct our business and generate net product revenue. Failure by a collaboration or commercialization partner to perform its duties under its collaboration or commercialization agreement with us (e.g. financial reporting or internal control compliance) may negatively affect us.

●	Our success depends upon our ability to obtain and protect our intellectual property and proprietary technologies. If the scope of our patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and drugs similar or identical to ours, and our ability to successfully commercialize our technology and drugs may be impaired. At the same time, if the scope of our patent protection is too broad, our competitors may challenge the validity and enforceability of our patents.
●	Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
●	We may not be able to enforce our intellectual property rights throughout the world.
●	If we or our partners are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.
●	We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
●	If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed.

●	If we fail to attract and keep key management, commercial, and clinical development personnel, we may be unable to successfully develop or commercialize our product and product candidates.
●	We will need to develop and expand our business, and we may encounter difficulties in managing this development and expansion, which could disrupt our operations.
●	Certain of our executive officers, directors, principal stockholders and their affiliates maintain the ability to exercise significant influence over our company and all matters submitted to stockholders for approval.
●	Our internal information technology systems, or those of our third-party CROs, CMOs, or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our drug candidates’ development programs and our commercialization of any products for which we receive regulatory approval.
●	Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.

●	Our stock price is, and we expect it to remain, volatile, which could limit investors’ ability to sell our stock at a profit.
●	We incur significant increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives.
●	We have identified a material weakness in our internal control over financial reporting related to non-routine share-based payment awards, which has been remediated. If we fail to develop and maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable laws and regulations could be impaired.

Clinical Drug Candidate: (molecular target)	Initial Target Disease	Stage of Development
Ublituximab IV (anti-CD20 mAb)	RMS	APPROVED
Ublituximab Subcutaneous (anti-CD20 mAb)	RMS	Phase 1 trial
Azer-cel	Auto-immune disorders	Phase 1

	●	the timing of our receipt of marketing approvals, the terms of such approvals, and the countries in which such approvals are obtained;
	●	the efficacy, safety and tolerability as demonstrated in clinical trials and as compared to alternative treatments;
	●	the timing of market introduction of BRIUMVI and any of our product candidates, as well as competitive products;
	●	the indications for which our products are approved, and other aspects of the approved labeling for such products;
	●	acceptance by physicians, advanced practitioners, major operators of neurology clinics, and patients of our products as safe, tolerable and effective treatments;
	●	the potential and perceived advantages or disadvantages of our products compared to alternative treatments;
	●	our ability to offer our products for sale at competitive prices;
	●	the availability of adequate reimbursement by third-party payors and government authorities;
	●	the extent of patient cost-sharing obligations, including copays and deductibles;
	●	changes in regulatory requirements by government authorities for our products;
	●	relative convenience and ease of administration;
	●	the prevalence and severity of side effects and adverse events;
	●	the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
	●	the effectiveness of our sales and marketing efforts, as well as those of any current or future partners;
	●	protecting our rights in our intellectual property portfolio;
	●	our ability to maintain a reliable supply of our products that meets market demand; and
	●	favorable or unfavorable publicity relating to our products or relating to the Company.

	●	regulatory authorities may withdraw approval or limit the approved indications for use of such products;
	●	regulatory authorities may require the addition of new or different labeling statements, including warnings or boxed warnings, precautions, or contraindications that could diminish the usage of the product or otherwise limit the commercial success of the affected product;
	●	we may be required to change the way such drug candidates are distributed or administered, or to conduct additional clinical trials;
	●	regulatory authorities may require a Risk Evaluation and Mitigation Strategy (REMS), a plan to mitigate risks, which could include a Medication Guide, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools;
	●	we may be subject to regulatory investigations and government enforcement actions;
	●	we may decide to remove such drug candidates from the marketplace;
	●	we may not be able to enter into collaboration agreements on acceptable terms and execute on our business model;
	●	we could be sued and held liable for injury caused to individuals exposed to or taking our products; and
	●	our reputation may suffer.

	●	research and development resources, including personnel and technology;
	●	regulatory experience;
	●	pharmaceutical development, clinical trial and pharmaceutical commercialization experience;
	●	experience and expertise in exploitation of intellectual property rights; and
	●	capital resources.

	●	the costs and time associated with the initial and ongoing training of commercialization personnel on the applicable disease states, products, competitors, and legal and regulatory compliance matters;
	●	the inability of commercialization personnel to obtain access to physicians or to effectively promote or provide education about BRIUMVI and any future approved products;
	●	the lack of complementary drugs to be offered by the Company, which may put us at a competitive disadvantage relative to companies with more extensive product lines;
	●	decisions by third-party payors to deny reimbursement of or delay coverage decisions regarding BRIUMVI or following approval of any product candidates;
	●	our inability to maintain a healthcare compliance program including effective mechanisms for compliance monitoring;
	●	our inability to establish and maintain commercial partnerships outside the U.S.;
	●	our inability, or the inability of a third party with whom we have partnered, to maintain the necessary regulatory approvals required to operate in markets outside of the U.S.;
	●	the timing of product availability for commercial sale following approval and continued product supply; and
	●	unforeseen costs and expenses associated with creating a commercialization organization.

	●	decreased demand for any products that we may commercialize;
	●	injury to our reputation and significant negative media attention;
	●	withdrawal of clinical trial participants;
	●	significant costs to defend the related litigation, including the risk that any individuals who may face such related litigation may in turn seek to recover from us;
	●	substantial monetary awards to trial participants or patients;
	●	loss of revenue; and
	●	the inability to commercialize any products or product candidates that we may develop.

	●	successfully complete clinical trials that meet their clinical endpoints;
	●	initiate and successfully complete all safety, pharmacokinetic, biodistribution, and non-clinical studies required to obtain U.S. and foreign marketing approval for our product and product candidates;
	●	obtain approval from the FDA and foreign equivalents to market and sell our product and product candidates, and maintain FDA, MHRA and EMA approvals of BRIUMVI for RMS;
	●	establish and maintain commercial manufacturing capabilities with third parties that are satisfactory to the regulatory authorities, cost effective, and that are capable of providing commercial supply of our product and product candidates;
	●	expand on our commercialization infrastructure to commercialize BRIUMVI, and/or entering into collaborations with third parties;
	●	obtain, develop, maintain, protect, and defend our intellectual property portfolio; and
	●	achieve market acceptance of BRIUMVI and any other products for which we may receive regulatory approval in the medical community and with third-party payors.

	●	the timing and success of the ongoing commercialization of BRIUMVI and any other products for which we receive regulatory approval;
	●	the costs and timing of clinical and commercial manufacturing supply arrangements for each product and product candidate;
	●	the costs of expanding our sales, distribution, and other commercialization capabilities;
	●	the costs and timing of regulatory approvals;
	●	the progress of our clinical trials, including expenses to support the trials and milestone payments that may become payable under our license agreements;
	●	our ability to establish and maintain strategic collaborations, including licensing and other arrangements;
	●	the costs involved in enforcing or defending patent claims or other intellectual property rights; and
	●	the extent to which we in-license or invest in other indications or product candidates.

	●	we will need to repay the indebtedness by making payments of interest and principal, which will reduce the amount of money available to finance our operations, our research and development efforts and other general corporate activities; and
	●	our failure to comply with the restrictive covenants in the Financing Agreement could result in an event of default that, if not cured or waived, would accelerate our obligation to repay this indebtedness, and the creditors under the Financing Agreement could seek to enforce its security interest in the assets securing such indebtedness.

	●	dispose of certain assets;
	●	change its lines of business;
	●	engage in mergers, acquisitions, joint ventures or consolidations;
	●	incur additional indebtedness;
	●	create liens on assets;
	●	pay dividends and make contributions or repurchase our capital stock; and
	●	engage in certain transactions with affiliates.

	●	successful completion of our clinical programs with positive results that support a finding of effectiveness and an acceptable safety profile of our product candidates in the intended populations within the timeframes we have projected;
	●	Investigational New Drug Applications (INDs) and clinical trial applications (CTAs), being cleared/issued/approved such that our product candidates can commence clinical trials;
	●	successful initiation and completion of preclinical studies and successful initiation of, enrollment in, and completion of clinical trials;
	●	sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials;
	●	receipt of regulatory approvals from applicable regulatory authorities for our product candidates;
	●	establishing commercially viable arrangements with third-party manufacturers for clinical supply and commercial manufacturing; and
	●	obtaining and maintaining patent and trade secret protection or regulatory exclusivity for our product candidates.

	●	the FDA or other regulatory authorities may require us to submit additional data or impose other requirements before permitting us to initiate a clinical trial;
	●	the FDA or other regulatory authorities or institutional review boards (IRBs) or Data Safety Monitoring Boards (DSMBs) or ethics committees (ECs) may not authorize us or our investigators to commence or continue a clinical trial or conduct a clinical trial at a prospective trial site or in a country; we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective clinical research organizations (CROs), the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
	●	clinical trials of our drug candidates may produce negative or inconclusive results, and we may decide, or regulatory authorities may require us, to conduct additional preclinical studies or clinical trials or we may decide to abandon drug development programs;
	●	the number of patients required for clinical trials of our drug candidates may be larger than we anticipate, and enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate;
	●	our third-party contractors, including our clinical trial sites, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial sites or investigators;
	●	we may elect to or regulatory authorities or IRBs, DSMBs or ECs may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;
	●	the cost of clinical trials of our product candidates may be greater than we anticipate;
	●	any shifts in the regulatory focus of the U.S. government as a reflection of changing administrations;
	●	the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate, including, without limitation, as a result of disruptions to our supply chains caused by global health crises, international conflicts in Russia and Ukraine and the Middle East, economic instability, or natural disasters;
	●	regulatory authorities may revise the requirements applicable to our product candidates, or such requirements may not be as we anticipate; and
	●	our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulatory authorities, IRBs, DSMBs or ECs to suspend or terminate the trials, or reports may arise from preclinical or clinical testing of other therapies in the same or a similar class that raise safety or efficacy concerns about our product candidates.

	●	be delayed in obtaining marketing approval for our product candidates;
	●	not obtain marketing approval at all;
	●	obtain marketing approval in some countries and not others;
	●	obtain marketing approval for indications or patient populations that are not as broad as intended or desired;
	●	be subject to post-marketing requirements or post-marketing commitments;
	●	be subject to increased pricing pressure; or
	●	have the drug removed from the market after obtaining marketing approval.

	●	we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is tolerable and effective for an indication;
	●	the FDA may not accept clinical data from trials conducted by individual investigators or in countries where the standard of care or the patient population, is potentially different from that of the United States;
	●	the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;
	●	we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
	●	the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies and/or clinical trials;
	●	the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a BLA, NDA or other marketing authorization submission to obtain regulatory approval in the United States or elsewhere;
	●	the FDA or comparable foreign regulatory authorities may identify issues related to the manufacturing processes or facilities of third-party manufacturers with which we or our collaborators currently contract for clinical supplies and plan to contract for commercial supplies; during the course of review, the FDA or foreign regulatory authorities may raise issues and request or require additional preclinical, clinical, chemistry, manufacturing, and control (CMC), or other data and information, and the development and provision of these data and information may be time consuming. We may not be able to generate the data within the time period necessary to obtain approval within the established regulatory review timelines, such as by a Prescription Drug User Fee Act (PDUFA) goal date or at all to satisfy the FDA or foreign regulatory authorities;
	●	the approval processes of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval; or
	●	interruptions or delays in the operations of the FDA and foreign regulatory authorities as a result of global health crises, inadequate government funding, political conditions or economic crises, international conflict, or natural disasters may negatively impact review, inspection, and approval timelines.

	●	our ability to generate revenues and achieve or maintain profitability;
	●	the demand for any products for which we may obtain regulatory approval;
	●	our ability to set a price that we believe is fair for our products;
	●	the level of taxes that we are required to pay; and
	●	the availability of capital.

	●	the Physician Payments Sunshine Act under section 6002 of the Affordable Care Act requires manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid or the Children’s Health Insurance Program to monitor and report certain information related to payments and other transfers of value to and the ownership and investment interests of physicians and certain other healthcare providers as well as teaching hospitals to the federal government for redisclosure to the public. CMS has the potential to impose penalties for violations of the Physician Payments Sunshine Act, depending on the circumstances, and reported payments also have the potential to draw scrutiny to our relationships with health care practitioners and academic medical institutions, which may have implications under the Anti-Kickback Statute and other healthcare laws;
	●	HIPAA, as amended by HITECH and other amendments, and its implementing regulations, which also imposes obligations on certain covered entity healthcare providers, health plans, and healthcare clearinghouses as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. HITECH created new tiers of civil monetary penalties, made civil and criminal penalties directly applicable to business associates, and gave state attorneys authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA laws and seek attorneys’ fees and costs;
	●	a wide range of federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers including those related to privacy;
	●	the FDCA and its implementing regulations, which among other things, strictly regulate drug product marketing and prohibit manufacturers from promotion and marketing of products prior to approval or for uses inconsistent with the FDA-required labeling;
	●	federal laws, including the Medicaid Drug Rebate Program, that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs;

	●	the Drug Supply Chain Security Act (DSCSA), which imposes obligations on entities in the commercial product supply chain, including manufacturers, to identify and track prescription drugs as they are distributed in the U.S.; and
	●	state law equivalents of some of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers, state transparency laws, state laws limiting interactions between pharmaceutical manufacturers and members of the healthcare industry, marketing restrictions 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 often are not preempted by federal laws, thus complicating compliance efforts.

	●	restrictions on product manufacturing, distribution or use;
	●	restrictions on the labeling or marketing of a product;
	●	requirements to conduct post-marketing studies or clinical trials;
	●	warning letters or other advisory actions;
	●	request for withdrawal of the products from the market;
	●	refusal to approve pending applications or supplements to approved applications that we or our subsidiaries submit;
	●	recalls;
	●	suspension or termination of ongoing clinical trials;
	●	fines, restitutions, or disgorgement of profits or revenues;
	●	refusal to permit the import or export of products;
	●	product seizure or detentions;
	●	injunctions or the imposition of civil or criminal penalties; and
	●	adverse publicity.

	●	have staffing difficulties;
	●	fail to comply with contractual obligations;
	●	experience regulatory compliance issues;
	●	undergo changes in priorities or become financially distressed; or
	●	form relationships with other entities, some of which may be our competitors.

	●	reliance on the third party for regulatory compliance and quality assurance;
	●	the possible breach of the manufacturing, supply or quality agreement by the third party;
	●	the possible misappropriation of our proprietary information, including our trade secrets and know-how; and
	●	the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

	●	the scope of rights granted under the license agreement and other interpretation-related issues;
	●	the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the license agreement;
	●	the sublicensing of patent and other rights under our collaborative development relationships and obligations associated with sublicensing;
	●	our diligence obligations under the license agreement and what activities satisfy those diligence obligations;
	●	the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and
	●	the priority of invention of patented technology.