Life Sciences

Representative Experience

  • Leading representation of indemnitor contract manufacturer in federal class action litigation brought against national drug store chain for alleged false and deceptive claims involving health supplement products.
  • Assisted practice physician practice group with an investigation related to the reuse of single-use devices.
  • Represented a manufacturer and packager of pharmaceuticals, over-the-counter drugs and dietary supplements in the negotiation of a supply agreement valued in excess of $100 million with a large, independent provider of over-the-counter products
  • Developed the cross-border distribution platform for a U.S health pharmaceutical company by crafting client’s international distribution, quality, and pharmacovigilance agreements as well as agreements for obtaining marketing authorization approvals in foreign jurisdictions
  • Counseled Canadian cosmetics company on ‘Made in USA’ designation under U.S. Customs regulations and Federal Trade Commission regulations
  • Counseled Canadian specialty pharmaceutical company in connection with U.S. Customs importer of record issues
  • Counseled U.S. precision immunotherapy company on clinical trial agreements for sites in the U.S. and in Europe, as well as on quality and pharmacovigilance agreements related to product testing
  • Represented U.S. affiliate of Israeli biopharmaceutical company in connection with successful release from U.S. Customs hold of active pharmaceutical ingredient imported to the U.S. for finishing and export purposes
  • Advised U.S. clinical stage biopharmaceutical company on cross-border distribution, quality, and pharmacovigilance agreements
  • Represented U.S. health pharmaceutical company in negotiation and execution of global supply agreement with medical device manufacturer and related global safety data exchange agreement
  • Advised U.S. life sciences company on agreements with third-party logistics providers for transport and storage of biopharmaceuticals across United States
  • Advised U.S. manufacturer of private brand OTC drugs and nutritionals on U.S. Customs rules of origin for active pharmaceutical ingredients sourced from around the world
  • Advised U.S. medical device company on drafting of contract manufacturing agreements with suppliers in the U.S., European Union, and South Korea, and provided guidance on own brand labeling requirements related to supply arrangements
  • Represented U.S. biopharmaceutical company in connection with supply and distribution agreements with specialty pharmacies
  • Represented U.S. specialty pharmaceutical company with the formation of its distribution platform in Mexico and Central America, including drafting of related distribution, quality, and pharmacovigilance agreements
  • Advised U.S. specialty pharmaceutical company with restructuring of its international operations through a Luxembourg holding company and drafted related interservices agreement between U.S. parent and Luxembourg affiliate
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  • Assisted a European manufacturer of skin care products with manufacturing and quality systems agreements for OTC drug sunscreen products, proper labeling for the products, and  quality control testing.
  • Represented CryoLife, Inc. in federal litigation in Georgia regarding alleged breaches of an international distribution agreement for a medical device.
  • Successfully represented biomedical company in connection with a contentious, multimillion dispute arising from an exclusive distribution agreement, which included claims for breach of contract, breach of implied duty of good faith and fair dealing, fraud, RICO, misappropriation of trade secrets, libel, tortious interference, and the Georgia deceptive trade practices act.
  • Successfully represented biomedical company in connection with a contentious, multi-million dispute arising from an exclusive distribution agreement, which included claims for breach of contract, breach of the implied duty of good faith and fair dealing, fraud, RICO, misappropriation of trade secrets, libel, tortious interference with business relations, and the Georgia deceptive trade practices act.
  • Represented the lead investor in a $30 million Series B round investment in an early stage medical products company.
  • Assisted clients with preparation of regulatory opinion for IPO filings.
  • Represented five highly distressed affiliated Debtors comprising the largest dairy farm in the Southeastern United States with operations in Georgia, Florida, Mississippi, and Texas. A plan was confirmed in January 2012.
  • Represented an interventional radiology practice in a sale to New York Stock Exchange listed company.
  • Advised a European pharmaceutical company on potential regulatory approval pathways, including 505(b)(2) new drug applications, that competitor products might use for U.S. market entry. Provided ongoing research on legal strategies to maintain market share against competitor products.
  • Successfully represented a Georgia home health provider in a request for reconsideration of a CMS contractor’s decision to terminate the provider’s Medicare enrollment.
  • Worked with the FDA’s Office of the Ombudsman to help facilitate meetings or discussions between a pharmaceutical company sponsor and the FDA on a stalled clinical development program and when communications broke down.
  • Worked with the FDA’s Office of the Ombudsman to help facilitate meetings or discussions between a pharmaceutical company sponsor and the FDA on a stalled clinical development program and when communications broke down.
  • Successfully represented former Chairman and CEO of public healthcare company in a civil lawsuit brought by the SEC alleging the client disclosed material inside information to someone outside the company who then traded securities based on that information. SEC dismissed case with prejudice after losing multiple pre-trial motions.
  • Represented Georgia-based biological medical device company in complex contract-based litigation concerning global distribution agreement.  Successfully resolved case favorably to client prior to trial.
  • Successfully defended medical device manufacturer in federal court bench trial against a claim for more than $10 million based on an alleged breach of license. Unlike a typical breach of contract claim, the issues in this case required proving patent non-infringement and tendering expert testimony in a niche area of x-ray technology. Mr. Desai also handled and successfully defeated an appeal of the judgment before the Eleventh Circuit and Florida Supreme Court.
  • Advised a client regarding developing an online privacy policy and related content for a website designed for consumers from several European Union member states. In addition to advising the client regarding the content of the online privacy policy, we also advised the client regarding obtaining the consent of individuals providing information through the site for the transfer of health information to the United States.
  • Assisted with due diligence for the acquisition of a pharmaceutical company.
  • Represented the lead investor in both a $10 million Series B round and $10 million Series C round investment in an early stage medical products company.
  • Supported successful settlement of claims of trade dress infringement and unfair competition under the Lanham Act brought against a pharmaceutical company by a competitor. This case involved the unique and rarely litigated issue of whether the appearance of pharmaceutical pills and capsules are protectable as trade dress.
  • Represented  CryoLife, Inc., a public biotech and life sciences company, in closing a $20 million secured financing facility from GE Capital Corporation.
  • Counseled a European pharmaceutical client on market exclusivity strategies under U.S. law and FDA regulations.
  • Successfully represented CryoLife, Inc. (CRY:NYSE), a leading medical device and tissue processing company focused on cardiac and vascular surgery, in its tender offer to acquire Cardiogenesis Corporation, a leader in the treatment of severe angina, for approximately $22 million.
  • Represented a shipping manager at peanut plant in an investigation by the U.S. Attorney’s Office and FDA related to salmonella outbreak. Client was not charged.
  • Facilitated process for an Israeli client to obtain a deferred payment plan for U.S. FDA prescription drug user fees.
  • Worked with an Israeli combination product manufacturer to determine the appropriate regulatory approval pathway for the product and assisted with developing supporting rationale for the FDA to review the product under the client’s preferred approval pathway.
  • Counseled American Breast Care LP, a worldwide manufacturer of post-mastectomy breast care products,  on the international protection of its intellectual property. The representation included the prosecution of applications to register trademarks in twelve foreign countries, as well as the creation and execution of monitoring and enforcement programs for the protection of intellectual property domestically and abroad.
  • Successfully defended a medical device manufacturer in federal court bench trial against claims for breach of a license agreement and assertion of over $10 million in damages. Unlike a typical breach of contract claim, the issues in this case required proving patent non-infringement and tendering expert testimony in a highly niche area of x-ray technology.
  • Successfully obtained a sanctions award and order rejecting a private company’s efforts to curtail shareholder rights by refusing shareholder inspection requests.
  • Represented a cigarette broker in an investigation by the U.S. Attorney’s Office and ATF alleging diversion of millions of dollars of cigarettes to avoid various federal and state taxes. Client was not charged.
  • Served as counsel to a specialty pharmaceutical company in connection with the formation of a strategic alliance with a medical device development company to develop, market and sell obstetric products.
  • Served as lead counsel in Regulation D offerings for innovative technology and life sciences company in the area of food safety.
  • Represented executive of small public company in criminal investigation related to alleged diversion of infusion drugs. Investigation closed with no charges filed.
  • Served as counsel to a public company in a sale by closed auction resulting in a $300 million cash merger transaction with Ecolab, Inc.
  • Served as counsel to Glades Pharmaceuticals, LLC, the generic products subsidiary of Stiefel Laboratories, in the sale of substantially all of its assets to Perrigo Company for approximately $60 million in cash.
  • Represented distributor of specialized medical device computer cables in sale to private equity fund.
  • Successfully defended an international retailer against charges of misappropriation of trade secrets and alleged Lanham Act violations on Motion for Summary Judgment in the United States District Court for the Northern District of Georgia; Affirmed in the 11th Circuit Court of Appeals.
  • Represented a private investor in connection with an investment in and the subsequent $236 million sale of a medical products company to a public company. Even though our client did not control management of the company, it did have a veto over a sale. As a result of this veto, and our client’s experience in negotiating transactions, our firm played a major role in negotiating and documenting the sale.
  • Served as lead counsel for CryoLife Inc., a medical devices company, in an $18.2 million sale of preferred stock in a registered direct offering.
  • Served as lead counsel in a $21.5 million sale of common stock in a “PIPE” transaction for a leading medical devices company.
  • Coordinated the nationwide defense for a major medical device manufacturer, in a series of product liability lawsuits.
  • Advised on takeover response strategies, including adoption of poison pills and employment agreements with parachutes for Microtek Medical Holdings, Inc., First Horizon Pharmaceutical Corporation and Profit Recovery Group International, Inc.
  • Served as counsel for First Horizon Pharmaceutical Corporation, a specialty pharmaceutical company, in its initial and follow on public offerings totaling approximately $245 million.
  • Served as counsel to seller in a $32 million divestiture by sale of assets of MedSurg Industries, a custom procedure tray division of Microtek Medical, to Allegiance Healthcare.
  • Represented CryoLife Inc., a leading medical devices company, by underwriting multiple public offerings of common stock.
  • Successful in aiding a public company in responding to informal SEC inquiries without a formal order of investigation issuing.
  • Successful in defense of putative 10b-5 class action litigation, prevailing by dismissal with prejudice on motion for failure to state a claim.
  • Served as counsel for acquirer in a stock-for-stock acquisition by merger of publicly traded healthcare company.
  • Served as counsel in initial public and follow on public offerings for Microtek Medical Holdings, Inc. totaling approximately $130 million.
  • Serving as general counsel to an innovation public company in the area of technology and life sciences, specializing in electrolyzed water production.
  • Reviewed product labeling and product claims for a pharmaceutical company manufacturing and distributing dietary supplements and over-the-counter drug products.
  • Advised start-up company in the area of hair restoration research regarding most advantageous regulatory pathway for development and marketing of biological-device combination product.
  • Advised both sponsors and principal investigators of human clinical trials regarding compliance issues and related responses to the FDA.
  • Advised multinational manufacturer of human biological and device products regarding approval strategies, advertising and promotional activities, and compliance issues.
  • Advised a research pharmaceutical company regarding compliance issues and related responses to the FDA.
  • Advised a urological physician regarding compliance issues and related responses to the FDA.
  • Serving as general counsel to the National Frozen & Refrigerated Foods Association.
  • Advised numerous medical device manufacturers concerning product recalls and market withdrawals to minimize business disruption, cost and damage to brand.
  • Helped prepare a Citizen Petition, submitted by King Pharmaceuticals, a publicly traded company subsequently acquired by Pfizer, defending a challenge to the company’s sale of an approved drug product; the product remains on the market to date.
  • Represented a number of pharmaceutical clients before local FDA district offices and the FDA’s Office of Compliance to develop proactively a phase-out program of Drug Efficacy Study Implementation (DESI) products before the FDA took enforcement action against the companies.
  • Represented the president of an herbal supplement/nutraceuticals company in U.S. Attorney’s Office criminal investigation regarding potentially adulterated and misbranded nutraceuticals. Investigation closed with no charges filed.
  • Advised a pharmaceutical company on product listing and registration with the Medicaid Drug Database.
  • Submitted amicus curiae brief to the Supreme Court of the United States on behalf of a biotechnology partnership in Bilski v. Doll, a case involving the proper test for determining patent-eligible subject matter.
  • Represented a specialty chemical products company in (i) a secured lending transaction focused on security of owned multi-state commercial real estate assets and related documentation and negotiation in relation to a $320 million credit facility and (ii) the negotiation of a sale and drafting of a Purchase and Sale Agreement for owned property valued at more than $3 million located in Brockton, Mass.