Inside M&A - Summer 2014

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“Commercially Reasonable Efforts” Diligence Obligations in Life Science M&A
by Kristian Werling, Richard B. Smith and Daniel Goldstein

More than 80 percent of all deals in the pharmaceutical, medical device and biotech industries include an earnout structure that provides some type of contingent or delayed payment of proceeds to the sellers (2012 SRS Life Sciences M&A Study).  Trends vary widely, but in many transactions, the earnout consideration can far exceed the up-front payment to the sellers.  This earnout consideration is frequently contingent on post-closing achievement of certain clinical study results, product approvals, reimbursement or sales.  As a result, sellers during transaction negotiations intensely focus on the obligations of buyers to use corresponding “diligence” to achieve the goals that will trigger the contingent payment to the seller.  This focus frequently comes to rest on the obligation of a buyer to use “commercially reasonable efforts” and the related definition of this obligation in transaction documentation.  This article reviews the common approaches to defining “commercially reasonable efforts” and analyzes several recent cases interpreting the definitions in deal documentation.

Common Approaches to Defining Commercially Reasonable Efforts

Outward Facing Definition

An outward facing definition of commercially reasonable efforts applies an industry-standard requirement or looks to other participants in the industry to define the diligence obligations of the buyer.  An example of this type of definition is:

“Commercially Reasonable Efforts” means the efforts consistent with the past practice of similarly situated pharmaceutical companies with respect to similarly situated pharmaceutical products.

This definition is generally viewed as more favorable to the seller of a technology, as it enables the seller to point to other industry standards that would have the buyer take additional steps to achieve the goal that would result in a payout on the earnout.

Inward Facing Definition

In contrast, an inward facing definition applies the buyer’s own standard for undertaking research, regulatory approvals, and sales and marketing efforts.  An example of an inward facing definition of commercially reasonable efforts is:

“Commercially Reasonable Efforts” means efforts consistent with the past practice of Buyer related to research and development, regulatory approval, commercialization, sales and marketing of similar oncology therapeutic products with similar market potential at a similar stage in its development.

This definition is more favorable to a buyer because it allows the buyer to point to its own investment thresholds and decision processes.  Buyers can typically point to a similar situation where a step or expenditure of funds would not have been taken.

No Definition

An option for buyers and sellers is to leave the term undefined.  In the event of a dispute, a judge or mediator would look to case law and the facts of the situation to determine whether the appropriate level of diligence was utilized.  It should be noted, however, that some states’ courts (most notably, Illinois) have interpreted terms such as “best efforts” and “commercially reasonable efforts” to be so vague as to be unenforceable.  (See Kraftco Corp. v. Kolbus, 274 N.E.2d 153, 156 (Ill. App. Ct. 1971).)  For an excellent discussion of courts’ varying interpretations of different due diligence standards, including commercially reasonable efforts requirements, see Kenneth A. Adams’ article.

Recent Cases

Many transaction documents incorporate mandatory arbitration provisions.  In fact, sophisticated buyers understand that there are frequently dramatic changes post-closing related to medical products and, therefore, include a variety of structures to amicably settle earnout related disputes outside the courtroom.  As a result, most disputes related to diligence obligations are handled out of court, which results in a limited number of cases that directly address the interpretation of commercially reasonable efforts obligations.  Two recent cases, however, have given insight to judges’ review of these obligations.

Volcano Corporation/CardioSpectra

In Banas v. Volcano Corp., the former owners of CardioSpectra, Inc. challenged whether Volcano Corporation used appropriate diligence to develop and sell CardioSpectra’s medical device system.  Banas v. Volcano Corp., 2014 WL 1309720 (ND Calif. 2014)  The merger agreement required Volcano to use “commercially reasonable efforts” and to “act in good faith” when working to achieve the goals that would result in additional merger consideration payable to the former shareholders of CardioSpectra.  The merger agreement defined commercially reasonable efforts as:

… the use of efforts, sales terms, expertise and resources normally used by [Volcano] for other products, which, as compared with the OCT Products; are of similar market potential at a similar stage in its development or product life, taking into account all reasonable relevant factors affecting the cost, risk and timing of development and the total potential of the applicable OCT Products, all as measured by the facts and circumstances at the time such efforts are due …

The definition used in the CardioSpectra merger agreement was inward facing and required the sellers to demonstrate that commercially reasonable efforts were not used compared with efforts made for other similarly situated Volcano products.  The court granted summary judgment to Volcano because the sellers failed to present any evidence that demonstrated Volcano’s efforts with similarly situated products.  The judge determined that without such evidence, the sellers could not make claim for breach of the merger agreement.

In addition to addressing commercially reasonable efforts, the judge examined whether Volcano failed to act in good faith in development efforts.  The merger agreement did not define act in good faith, so the court looked to case law to determine the standard.  Examining the evidence, the court found that Volcano had expended significant resources, hired sufficient personnel and had not willfully abandoned the development of the CardioSpectra system.  As such, it determined that Volcano had not breached the merger agreement by failing to act in good faith.

Sekisui/America Diagnostica, Inc.

Also in the first quarter of 2014, a judge examined counterclaims in a lawsuit brought by Sekisui America against the former shareholders of America Diagnostica, Inc. (ADI).  Sekisui America Corp. v. Hart, 2014 WL 687222 (S.D. NY 2014).  In counterclaims against Sekisui, the former shareholders of ADI alleged that Sekisui America had breached the stock purchase agreement by failing to use “commercially reasonable efforts” and omitting actions “with the intent of preventing [ADI] from meeting … revenue targets …”  The term commercially reasonable efforts was not defined in the stock purchase agreement.

The court found that the sellers had failed to prove a breach of the diligence obligations because they did not present evidence establishing the objective standard for commercially reasonable efforts in the regulatory context of the U.S. Food and Drug Administration, nor did they explain how Sekisui America deviated from that standard.  Further, the court found that there was no evidence demonstrating that Sekisui America intentionally omitted actions to prevent the revenue targets from being met.

Tips and Takeaways

Inward Facing Definitions Add Hurdles for Sellers

As demonstrated by Volcano, an inward facing definition of commercially reasonable efforts adds significant hurdles for the sellers attempting to prove that diligence requirements were breached.

Additional Requirements to Use “Good Faith” Should Be Defined

Sometimes drafters will toss in additional references or requirements to use good faith in the diligence obligation section of an M&A document.  Such terms should be cautiously used because, as seen in both Volcano and Sekisui America, this allows a seller to further attack the buyer’s effort.  If good faith is an obligation of the buyer, consider defining the requirement further.

Define the Impact of a New Technology Acquisition

Acquisition documentation frequently fails to address the impact of newly acquired technology.  If it is not specifically addressed in the document, courts will be left to discern the intent of the parties if a new acquisition is made that impacts existing diligence or milestone obligations.  Ideally, a buyer would have a clear statement that the acquisition of a new technology involving the same therapeutic area is permitted.

Business Teams Should Be Aware of Implications of “Shelving” the Acquired Technology

Although not examined in either Volcano or Sekisui America, other litigation and mediation involving diligence obligations have shown that sellers can win large damage awards if the buyer’s business team “shelves” or otherwise abandons an acquired technology where the acquisition documentation included a diligence obligation.  It is worth the additional time and effort to avoid protracted litigation to establish strong documentation as to why development, regulatory or sales efforts related to a technology were shelved.

Consider the Impact of Specific Diligence Milestones

In addition to requiring a buyer to use commercially reasonable efforts, sellers will often require a buyer to meet certain specific diligence milestones, regardless of whether buyer is using commercially reasonable efforts.  The diligence milestones are typically key product development or commercialization events, and will often trigger one or more earnout payments.  A buyer’s failure to achieve a milestone may result in breach of its obligations to a seller, even in the event that a buyer was otherwise using commercially reasonable efforts to meet such milestone.

Buyers Should Consider the Benefit of Safe Harbor Provisions

In the event that the buyer satisfies a specified milestone in a timely manner, a safe harbor provision can deem a buyer to have used commercially reasonable efforts in achieving such milestone.  This will relieve the buyer of all or part its obligation to use commercially reasonable efforts.  Such milestones may include development achievements, regulatory approvals or financial events such, as net sales achievements.  Preferably, a buyer will want to negotiate optional safe harbor events that, if met, will demonstrate the buyer’s use of commercially reasonable efforts without creating mandatory obligations.

Consider Third Party Diligence Obligations

Buyer should be aware that, to the extent that it acquires intellectual property through a sublicense issued by a seller (i.e., seller has in-licensed intellectual property from a third-party licensor), the seller may have its own diligence obligations it owes to its third-party licensor that will need to be satisfied to retain its in-license.  It is also likely that, with respect to the technology sublicensed to the buyer, the seller will rely on the buyer’s diligence to satisfy the seller’s obligations to its licensor.  Therefore, the seller’s hands may be tied when it comes to negotiating a buyer’s diligence obligations and remedies.  If such diligence obligations and remedies are unacceptable to the buyer, the only acceptable alternative may be for the seller to renegotiate its diligence obligations with the third-party licensor.

Define Specific Circumstances Under Which Buyer Will Be Excused

Despite good faith intentions, events can occur that make unreasonable the continued use of commercially reasonable efforts.  In addition to force majeure, such events can include failure to obtain regulatory approval as expected, unexpected safety concerns, unexpected market shifts or unfavorable commercial circumstances that adversely affect product viability, and inability to obtain commercially viable reimbursement levels.  It is best to anticipate the possibly of such events and provide reasonable tolling and other remedial provisions.

Consider Disclaimers

If a buyer and seller agree that no specific diligence standard will be required (i.e., the buyer will not be required to use commercially reasonable efforts, or any other level of efforts for that matter), the agreement should include a disclaimer on point.  It is otherwise too easy for a court to imply at least some level of good faith efforts into the agreement that were never intended or agreed to by the parties.

Contingent Payment Installment Sales—A Seller’s Dilemma
by Jeffrey K. Ekeberg and Jeffrey Wagner

Parties have increasingly looked to earnouts or contingent payments to bridge any gap in value between the buyer and seller and to incentivize target owners who continue to work in the business post-closing.  Subject to certain exceptions, if these earnouts or contingent payments are to be received in a taxable year after the sale year, they are viewed as a form of deferred consideration, which may be eligible to be reported for U.S. federal income tax purposes on the “installment method.”  We address how the tax rules treat contingent payment sales that are reported on the installment method and highlight a few important considerations for sellers as they analyze whether to elect out of the installment method or otherwise take affirmative actions to structure the deal to avoid application of the installment method.

The Installment Method

The installment method is an option for certain sellers to defer reporting taxable gain until payments are received in connection with the sale of certain types of property.  A seller may elect out of the installment method and recognize gain in the year of the sale in an amount equal to the excess of (i) the total consideration received, including the full fair market value of any installment obligation received (including the fair market value of the right to receive any contingent payments), over (ii) the seller’s basis in the property sold.  If a seller elects out of the installment method and does not receive the full amount estimated as the fair market value of the installment obligation (including any right to receive contingent payments), the seller is not permitted to recompute the amount of income recognized in the year of sale.  Instead, the seller may only take a loss (generally, a capital loss) when it is ultimately determined that the installment obligation is worthless.

The installment method generally provides that each payment received by the seller in a taxable year subsequent to the sale year is comprised of three parts:  a partial return of the seller’s basis in the property sold, a portion of the gain recognized on the sale and interest.  When a seller reports a transaction on the installment method, the timing of the basis recovery is dependent upon the terms of the deferred consideration.  When either the selling price of the property or the time period over which the deferred payments are to be received is fixed, the seller generally recovers its basis in the property sold ratably and reports the associated income in the year in which the payments are received.  The rules are significantly more complex, however, when both the timing and the amount of any deferred payments is not known.

Contingent Payment Installment Sales

If a seller can compute the maximum possible amount that could be received in an installment sale (e.g., when an earnout is capped at a fixed dollar amount), the seller is required to compute the taxable gain when a payment is received based upon an assumption that the seller will actually receive the maximum possible amount under the agreement.  If less than the stated maximum selling price is received, this method defers the seller’s recovery of basis, as compared to a scenario where the full payment schedule is known.

If there is no stated maximum selling price but the time period during which payments will be received is fixed (e.g., when an uncapped earnout is scheduled to be paid following each of the three fiscal years following closing), a seller may only recover the basis in the property sold in equal annual increments during the scheduled time period of payments.  In a typical situation where the payments received by the seller are front loaded, this method can result in a significant acceleration of taxable gain.

Finally, if there is no stated maximum selling price nor a fixed time period during which payments will be received (e.g., when an uncapped earnout is contingent on the achievement of certain milestones rather than payable during a fixed time period), the seller may only recover basis in the property sold in equal, annual increments over 15 years.  Once again, when the payments received by the seller are front loaded, this method of basis recovery may result in a significant acceleration of taxable gain.

If the gain recognized with respect to a particular sale pursuant to the application of these rules will distort the seller’s income over time, the seller may seek a ruling from the Internal Revenue Service (IRS) to permit an alternative means of basis recovery or apply an “income forecast” method, with respect to the sales of certain types of property (e.g., mineral property, motion picture film, television film or taped television show).

Interest Charge on Installment Obligations in Excess of $5 Million

If, at the end of a particular taxable year, a seller holds installment obligations that, in the aggregate, exceed $5 million, the seller is required to pay an additional tax akin to an interest charge on the tax liability deferred as a result of the installment method.  If an installment obligation is not contingent, interest is generally payable at the federal short-term rate (currently 0.32 percent) plus 3 percent on the product of (i) the maximum capital gains rate in effect for the seller and (ii) the amount of gain deferred with respect to the portion of the installment obligation that exceeds $5 million.  Thus, if a seller sold property with a basis $800,000 in exchange for an $8 million installment obligation, for each taxable year during which such installment obligation remained outstanding, the seller would be required to pay interest on the product of (i) maximum capital gains rate applicable to the seller, currently 20 percent for individuals and 35 percent for corporations, and (ii) $2.7 million (three-eighths of the total $7.2 million gain).  Depending on how the deferred consideration is structured, this interest charge can significantly reduce the present value of the seller’s net after-tax cash proceeds.

Interest Charge on Contingent Payment Installment Obligations

When the installment obligation does not provide for the payment of a fixed amount, the application of this interest charge is not clear.  The Internal Revenue Code directs the U.S. Secretary of the Treasury (Secretary) to prescribe regulations as may be necessary to carry out the interest charge provisions in the case of contingent payments.  However, the Secretary has not yet proposed or promulgated any such regulations in the 26 years that have passed since the provisions were enacted.

Assuming that contingent payment installment obligations are subject to the interest charge provisions (despite the fact that no regulations have been issued) a seller could assert that the formula to compute the amount of the interest charge yields zero because the face amount of a wholly contingent installment obligation is undefined.  The IRS, however, has asserted that even without any regulations, contingent payment installment sales are subject to the interest charge provisions.  In support of its position, the IRS has argued that failing to apply the interest charge provisions to contingent payment installment obligations would result in sellers who elect out of the installment method and are required to value and report contingent payments in the year of sale paying more tax than sellers who use the installment method to defer their tax liability.

Informal IRS Guidance on Contingent Payment Installment Obligations

Although the IRS has been clear in its position that the interest charge provisions should apply to contingent installment obligations, it has been much less clear in defining how the provisions should apply.  In the absence of regulations, the IRS has asserted that sellers may use any reasonable method of calculating the deferred tax and interest on the deferred tax liability with respect to contingent payment installment obligations.

In informal guidance, the IRS has indicated that sellers may report (and pay on a current basis) the interest charge based on an assumption that the maximum amount will be received under the installment obligation.  Alternatively, sellers may simply wait and use the amounts actually received to calculate the actual amount of tax deferred and use that amount as the basis upon which the interest is computed and paid (the look-back method).  Paying the interest charge on a current basis, while assuming that the full amount of any contingent consideration will be received, accelerates payments to the IRS when cash may not be available from the sale and could also result in interest being paid on amounts never received.  This could significantly reduce the present value of the after-tax proceeds to the seller; hence, the remainder of this discussion focuses upon the application of the look-back method.

Application of the look-back method should account for the benefit of the $5 million threshold amount that is excluded from the interest charge provisions.  Because the total “face amount” of a contingent payment installment obligation cannot be determined for purposes of determining the amount by which the face amount of the installment obligation exceeds $5 million, the IRS suggested that a seller treat the first $5 million of payments received after the year of sale as exempt from the interest charge provisions.  The tax liability attributable to the gain on payments received in the year(s) subsequent to the year of sale in excess of $5 million is subject to the interest charge.

With respect to these subsequent payments, the deferred tax liability is determined by multiplying the portion of the payments received that represents gain (the total amount of the payments received less any imputed interest and the amount of the basis in the property sold that is allocable to the taxable year) by the maximum capital gains rate applicable to the seller.  This deferred tax liability is then multiplied by the relevant rate in effect for the month with or within which the taxable year ends to obtain the amount of interest due.  Additional interest on the interest is calculated for the period beginning on the due date of the seller's return for the taxable year in which the sale occurred and ending on the due date for the seller's return for the taxable year immediately preceding the taxable year in which the relevant principal payment was received (the interest period).

Although arguably this method for applying the interest charge provisions to contingent payment installment obligations is reasonable, it has only been discussed by the IRS in informal non-precedential guidance.  As a result, sellers should be wary as they consider applying it to their own circumstances because there is nothing that binds the IRS to this method.

Takeaway—Choosing a Method

A seller who accepts contingent consideration should carefully consider the manner in which the seller intends to report the transaction for tax purposes.  If the seller elects out of the installment method and takes into income any deferred consideration in the year of sale, the seller must be prepared to report as income the fair market value of any right to receive contingent payments.  By electing out of the installment method, however, the seller will not be subject to the interest charge provisions.  If the amount reported as income with respect to the contingent consideration is not ultimately received, the seller should understand that the only recourse may be to report a capital loss when the installment obligation is ultimately determined to be worthless.

If, on the other hand, the seller decides to report the transaction on the installment method, the fair market value of the right to receive the contingent payments does not need to be determined.  The seller must instead evaluate the application of the interest charge provisions.  If the seller does not apply an interest charge with respect to the contingent consideration, the IRS could challenge that position.  If the seller takes a more conservative approach and uses the look-back method to apply the interest charge provisions, the IRS should be less likely to challenge the approach because it has acknowledged the reasonableness of the look-back method in informal guidance.  Nevertheless, the seller should be aware that there is no precedential guidance authorizing the look-back method.

As sellers agree to accept contingent consideration, they should be aware of the options available to report any income associated with the sale and ensure that, regardless of the manner in which they intend to report the transaction for income tax purposes, the structure does not give rise to any unanticipated tax risk.  There may be alternative structures for the transaction that result in greater certainty as to the present value of the seller’s after-tax proceeds.

Identifying and Mitigating Liabilities in Medical Device M&A
by Glenn Engelmann, Jake Townsend and Kristian Werling

Medical device mergers and acquisition (M&A) transactions are accelerating as greater regulatory clarity develops and review times shorten in the U.S. Food and Drug Administration (FDA) regulatory process and the capital markets react positively to consolidation and new public offerings.  Additionally, private equity funds are participating in an increasing number of transactions involving firms with later stage or “mature” medical products.  While the medical device industry offers great opportunities, understanding and mitigating potential liabilities presented by device transactions is essential to manage investment losses.

Unique Liabilities Presented by Medical Device Companies

Adverse Events and Recall Liabilities

Medical device companies are highly regulated by the FDA and other similar global regulators.  Manufacturers, distributors and health care facilities are required to report adverse events, which are collected and posted publicly.  Medical device companies also may undertake voluntary or involuntary recalls or field corrections.  Investigating and responding to adverse event reports, other product performance issues and addressing recalls and field corrections can impact profit margins and corporate reputation.  Given the long life of some medical devices, adverse event response, product performance and recall issues can be triggered by legacy products from which a buyer is no longer profiting but came as part of an acquisition.

Products Liability

Particularly in the U.S. market, medical device companies are faced with a potentially large number of lawsuits—and, as a result, potential liabilities—related to patient injuries and death from past sales of a device.  State product liability laws vary widely, but most states have statutes of limitations that run for two to three years from the time of the injury or discovery of the injury, creating potential liability for years following an acquisition.  Product liability due diligence should focus on adverse event reporting and product quality databases, as well as a robust insurance coverage assessment.

Intellectual Property Liabilities

Intellectual property (IP) is clearly a valuable asset for device companies, but it also presents potential liabilities due to risk of infringement.  Strong freedom-to-operate diligence is critical to identifying potential IP infringement liabilities.  Although IP infringement actions generally carry a relatively short three-year statute of limitations, the clock starts running from the date of discovery of the infringement.  As a result, IP infringement liabilities can have lengthy tails and may not present within any certain time frame after the closing of an acquisition.

U.S. Federal Health Care Program Liabilities

Selling medical products in the United States is governed by a complex range of statutes and regulations.  There are potential compliance issues under “fraud and abuse” laws, including the Anti-Kickback Statute and False Claims Act.  For medical device manufacturers, the fraud and abuse laws focus in large part on the marketing and promotion of products, with a particular emphasis on financial relationships with referral sources and off-label promotion.  The potential liability extends for a significant period after the closing of an acquisition, since most federal health program fraud and abuse laws carry a lengthy seven-year statute of limitations.  In addition, the “Sunshine” provisions of the Affordable Care Act apply to medical device companies; this new fraud and abuse requirement mandates the disclosure of most financial relationships with physicians and teaching hospitals.  There are stiff penalties associated with failing to comply with these requirements.

FDA and Global Regulatory Requirements

The FDA and other global regulators enforce compliance requirements associated with geographic-specific regulatory schemes, such as Current Good Manufacturing Practice requirements.  Historical warning letters, regulatory inspections and audit observations can have an impact on future operations and products in the marketplace if not corrected.  In addition to the cost of correcting open regulatory issues, investors need to consider the implications of a history or pattern of regulatory issues and the impact on the quality and value of the management team and business.

Anti-Corruption

The U.S. Foreign Corrupt Practices Act (FCPA), the UK Bribery Act and other global anti-corruption laws apply in a unique way to manufacturers and distributors of medical products.  In many countries, physicians and hospital administrators are employees of government health care programs, leading to their treatment as a “foreign official” under the FCPA.  As such, the FCPA’s restrictions on bribery apply to nearly all purchasers of a medical device manufacturer’s products, whether directly from the manufacturer or through a distributor.  The FCPA statute of limitations is five years.  The global focus on life sciences companies, including medical device firms, casts a wide net of potential liability.  Device manufacturers and distributors should have or establish strong anti-corruption controls.  Potential buyers of a medical device firm should conduct thorough diligence on the scope of any non-U.S. business and the corresponding relationships with international health officials.

Structures to Mitigate and Limit Liabilities of Buyers in M&A

Deal Structure

While corporate structures and tax issues typically dictate the M&A deal structure, in the medical device industry, the deal structure may be used to isolate or mitigate historical liabilities.  Careful consideration should be given in initial stages of the deal’s negotiation as to how its structure can be used to isolate and mitigate historical medical device and potential regulatory liabilities.  In device deals, the corporate and other tax objectives must be understood in the context of and evaluated against the universe of potential medical device liabilities.

In contrast to health services transactions, in which Medicare and Medicaid liabilities transfer to a buyer when it assumes the historical billing numbers (regardless of whether the deal is structured as an asset purchase, merger or stock purchase), medical device manufacturers may have more flexibility with deal structures.  For example, most medical device manufacturers do not bill Medicare or Medicaid, and a buyer may not need to assume a target company’s historical billing numbers.  As a result, a buyer may mitigate some historical exposure to the Anti-Kickback Statute and False Claims Act by purchasing assets into a new entity instead of acquiring the business by a merger or stock purchase.  Asset acquisition deal structures can also help to isolate historical products liability, global corruption issues and other historical operational liabilities.

Indemnification Package

With limited exceptions, indemnification packages for medical device deals do not materially differ from other health industry indemnification structures.  Under a typical indemnification scheme in a purchase agreement, the seller would be liable for damages only if the buyer can prove that the liability resulted from a breach of a representation or covenant set forth in the purchase agreement.  However, buyers in medical device deals negotiate “line item” or “specific” indemnities for the specific liabilities or risk areas that are identified during due diligence.  A line item or specific indemnity requires a seller to compensate the buyer for a liability without having to prove that the liability resulted from a breached representation or covenant.

For example, a specific indemnity might be considered if, during due diligence, an abnormal level of FDA adverse event reports are identified with respect to one of the target’s medical devices that has since been discontinued.  To mitigate this potential liability, the buyer would request that the seller provide a specific indemnity for this liability.  It is important for the buyer to request coverage for not only recall and regulatory liabilities related to the product, but also product liability issues.  Additionally, if a specific indemnity covers the costs of a recall, it is important that the buyer have coverage for not only recalls that are required by the FDA or other regulatory authority, but also for voluntary recalls (which are far more common in the medical device industry).  Similarly, given the lag time between the development of a situation and action taken by a regulatory body, an indemnity of unlimited or longer duration for any regulatory actions arising from pre-closing activities should be considered.

IP Indemnification

One area where indemnification packages in medical device transactions deviate from other industries is the treatment of IP.  According to the 2012 SRS Life Sciences M&A Study (its most recent available data), in life science M&A, the survival period for IP indemnification in 45 percent of all deals is longer than the general survival period.  The survival period is typically longer than the general survival period by 6–18 months.  Sometimes a survival period can extend through the actual or projected commercialization of a defined product line.  These extended indemnification periods reflect the fact that a medical device company may have made pre-closing risk decisions and choices in the course of its business with respect to its IP, including new products or products under development, that a buyer should receive protection for post-closing.

Escrow Funds

According to the 2012 SRS Life Sciences M&A Study, escrow sizes in life sciences deals tend to be slightly smaller than other industries at closing.  However, 45 percent of all deals provide for the escrow fund to be replenished or increased when a milestone or other contingent payment is made, resulting in greater escrow protection for the buyer.  Furthermore, according to the SRS survey, nearly 70 percent of all life sciences deals have an escrow fund period of 18 months or more.  Longer escrow periods can provide buyers with greater comfort with respect to unidentified or unknown liabilities.

Representations and Warranty Insurance

A robust market is developing for representation and warranty insurance for medical device deals, with numerous insurers entering the market in recent years.  These insurance products are particularly attractive in markets that pose high levels of liabilities that may be difficult to fully understand and identify through due diligence.  An example is medical device companies that distribute globally through extensive distributor networks that are difficult to fully diligence.  When using representation and warranty insurance to mitigate certain deal liabilities, it is important to engage in early discussions with brokers to develop an insurance package that can cover unknown regulatory and product liability issues.  Of course, representation and warranty insurance require careful coordination with lawyers and brokers to ensure that the representations are thoughtfully drafted to cover the unknown issues that the insurance package is intended to cover and adequate timing is given for insurer review to issue the policy.

Conclusion

Medical device M&A transactions present a range of liabilities specific to medical devices.  Many liabilities relating to medical devices can be identified and evaluated through due diligence, while others remain latent and subject to years of ongoing potential liability.  Certain deal structures and indemnity provisions, though, can help a buyer of a medical device company navigate that complex network of potential liabilities.

 

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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  • Comply with our legal and regulatory responsibilities and to enforce our rights.

How is your information shared?

  • Content and other public information (such as an author profile) is shared on our Website and Services, including via email digests and social media feeds, and is accessible to the general public.
  • If you choose to use our Website and Services to communicate directly with a company or individual, such communication may be shared accordingly.
  • Readership information is provided to publishing law firms and authors of content to give them insight into their readership and to help them to improve their content.
  • Our Website may offer you the opportunity to share information through our Website, such as through Facebook's "Like" or Twitter's "Tweet" button. We offer this functionality to help generate interest in our Website and content and to permit you to recommend content to your contacts. You should be aware that sharing through such functionality may result in information being collected by the applicable social media network and possibly being made publicly available (for example, through a search engine). Any such information collection would be subject to such third party social media network's privacy policy.
  • Your information may also be shared to parties who support our business, such as professional advisors as well as web-hosting providers, analytics providers and other information technology providers.
  • Any court, governmental authority, law enforcement agency or other third party where we believe disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect our rights, the rights of any third party or individuals' personal safety, or to detect, prevent, or otherwise address fraud, security or safety issues.
  • To our affiliated entities and in connection with the sale, assignment or other transfer of our company or our business.

How We Protect Your Information

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at privacy@jdsupra.com.

Children's Information

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to privacy@jdsupra.com. We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to privacy@jdsupra.com.

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at www.jdsupra.com) (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit legal.hubspot.com/privacy-policy.
  • New Relic - For more information on New Relic cookies, please visit www.newrelic.com/privacy.
  • Google Analytics - For more information on Google Analytics cookies, visit www.google.com/policies. To opt-out of being tracked by Google Analytics across all websites visit http://tools.google.com/dlpage/gaoptout. This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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