Daniel Mateo

Daniel Mateo is a litigation and business disputes attorney who has significant and broad-based experience helping domestic and international pharmaceutical and other life sciences companies manage their contract risk and resolve their business disputes. Mr. Mateo handles a variety of business disputes that arise during a pharmaceutical product's life cycle, including during pre-clinical and clinical development, regulatory submission and approval, product launch, promotion, supply, commercialization and distribution. He has been the lead lawyer on a number of significant litigations, trials and arbitrations involving pharmaceutical companies.

Mr. Mateo is particularly adept at pre-dispute counseling and investigations. In addition, Mr. Mateo has a significant background in counseling clients faced with pharmaceutical product recalls and defense of related consumer product liability and class actions.

As a native Spanish speaker of Puerto Rican descent, an active and engaged member of the Hispanic National Bar Association, and a past president of the Hispanic Bar Association of New Jersey, Mr. Mateo regularly mentors young lawyers and strongly supports bar association diversity and inclusion initiatives.

Mr. Mateo has substantial experience practicing in New Jersey state and federal courts. He has been an active member of the New Jersey State Bar Association and has served on a number of committees focused on increasing diversity within the State Bar.

Admitted in Florida and New Jersey only.

Representative Pharmaceutical Experience

Pharmaceutical Commercial Litigations

• Representing a foreign active pharmaceutical ingredient (API) manufacturer and its U.S. subsidiary in a breach of contract action resulting from the unconsummated sale of an API manufacturing facility located in China; obtained precedential dismissal of foreign parent for lack of personal jurisdiction
• Representing a U.S. pharmaceutical distributor against its foreign manufacturing and profit share partner for failure to supply and breach of co-development agreement
• Second-chaired a 10-day jury trial in New Jersey federal court for the consumer products division of a major pharmaceutical company facing claims of trademark infringement
• Second-chaired a Paragraph IV patent infringement action in the U.S. District Court for the District of Delaware brought against an Indian pharmaceutical company and its U.S. subsidiary under the Hatch-Waxman Act
• Successfully represented and obtained a multimillion-dollar settlement on behalf of a leading pharmaceutical company that brought suit in New Jersey state court against its contract manufacturer for wrongful termination of the parties' development and supply agreement for over-the-counter (OTC) cold and allergy medications
• Served as lead defense counsel for a pharmaceutical company facing a claim for $50 million in alleged profit-sharing, royalty and other damages resulting from a breach-of-contract action brought in the U.S. District Court for the Eastern District of Virginia
• Successfully defeated a temporary restraining order and preliminary injunction action commenced against a pharmaceutical company in the U.S. District Court for the Eastern District of Virginia seeking mandatory injunctive relief in the form of continued supply of finished-dose pharmaceutical products
• Defended a pharmaceutical company in a breach-of-contract action brought in federal court in Pennsylvania under a development, manufacturing and supply agreement seeking profit-sharing and royalty payments
• Defended a distributor of an OTC nutraceutical product against a collection action brought in New Jersey federal court and asserted counterclaims based on fraudulent inducement and product adulteration, and coordinated response to related inquiry commenced by the Federal Trade Commission (FTC) against the plaintiff for misrepresenting product safety and efficacy
• Defended the consumer products division of a branded pharmaceutical company against an action brought in New Jersey by a competitor that sought to prevent the client from hiring a senior research scientist for its oral healthcare department based on claims of "inevitable disclosure" of confidential information and/or trade secrets

Pharmaceutical Arbitrations

• Representing a specialty pharmaceutical company in an International Centre for Dispute Resolution (ICDR) administered arbitration alleging breach of a purchase and sale agreement for failure to pay milestones and use commercially reasonable efforts to market the acquired pharmaceutical products
• Represented a foreign pharmaceutical company in an International Chamber of Commerce (ICC) administered arbitration and related injunction proceedings in the Southern District of New York challenging the unilateral termination of an exclusive license and distribution agreement as a result of alleged diversion of the product outside of the licensed territory
• Represented a drug discovery biotech company in a Judicial Arbitration and Mediation Services (JAMS) arbitration alleging breach of a research, license and collaboration agreement based on collaboration partner's failure to use commercially reasonable efforts to develop therapeutics for patients with genetically defined cancers
• Served as lead defense counsel for a New Jersey-based pharmaceutical company faced with five separate American Arbitration Association (AAA) arbitration hearings in Chicago involving an $8 million dispute with a business partner under a product development and supply agreement
• Commenced an AAA arbitration proceeding in Washington, D.C., against a pharmaceutical client's exclusive marketing partner as a result of that partner's failure to use commercially reasonable efforts to plan and prepare for the launch of an U.S. Food and Drug Administration (FDA)-approved pharmaceutical product
• Defended a pharmaceutical company in an AAA arbitration proceeding in Chicago that sought damages in excess of $2 million as a result of the termination of a license and transition license agreement for a topical psoriasis product

Pharmaceutical Counseling and Advice

• Counseled a pharmaceutical company that was party to a collaboration, supply and distribution agreement in a pre-litigation dispute with its manufacturing partner over a price increase implemented after the issuance and acceptance of a number of purchase orders
• Advised a client on liability and risk-mitigation issues arising from voluntary recall of allegedly mispackaged birth control pills
• Retained and supervised local counsel in Mumbai, India, on behalf of a New Jersey-based pharmaceutical company, and successfully obtained a stay of arbitration in Chennai, India under the Indian Arbitration and Conciliation Act of 1996
• Negotiated and drafted an amended supply agreement and release for a U.S.-based pharmaceutical company involved in a dispute with its Spanish active pharmaceutical ingredient (API) supplier
• Retained and supervised local counsel in Argentina in connection with a pending litigation and other corporate governance issues inherited by a U.S. pharmaceutical company that purchased a manufacturing facility in Buenos Aires
• Collaborated with counsel in the Dominican Republic to assist a pharmaceutical client with the termination of its Santo Domingo-based distributor
• Assisted a pharmaceutical client with identifying API and finished-dose manufacturing facilities in Puerto Rico, oversaw initial due diligence, retained local counsel in Puerto Rico, helped with initial negotiations and term sheets between the client and sellers and assisted with the negotiations with the Puerto Rico Industrial Development Company

Pharmaceutical Products Liability

• Serving as national products liability counsel to New Jersey-based pharmaceutical company faced with several individual failure to warn claims
• Served as national counsel to pharmaceutical company after it faced dozens of individual wrongful pregnancy claims and two class actions for reimbursement damages resulting from a recall of mispackaged birth control pills
• Defended a branded pharmaceutical company in a putative national class action filed in New Jersey state court, which included claims for personal injury, off-label marketing, consumer fraud and medical monitoring arising from the antiarrhythmic product amiodarone
• Counseled and defended a pharmaceutical sales and marketing company named in more than 100 mass tort actions involving the pharmaceutical product Baycol, including the development of litigation strategy, retention and management of local counsel, overseeing the review and production of more than 1 million documents and the successful negotiation of a defense/indemnity agreement with the branded drug company