Andres Liivak is the Co-Chair of Kaye Scholer’s Life Sciences Industry Group and a Partner in the firm’s Corporate Department. Working together with the firm’s highly regarded, collaborative, multidisciplinary life sciences team, Andres helps life sciences healthcare industry clients develop comprehensive solutions and manage risk to achieve their business objectives. In his practice, Andres focuses on putting in place new deals as well as counseling with respect to and renegotiating existing transactions, including:
- Priority, high value deals – examples include in-licenses of blockbuster drugs; acquisitions of target companies and products, including with sales force; divestures of approved products together with supply chain transition; collaborative development and commercialization license arrangements; contentious renegotiation of major commercial contracts relating to key products; and settlement of major IP and contract litigation with business deals.
- Deals outside a client's comfort zone or recent experience – examples include co-promotion arrangements and companion diagnostic deals.
- Unusually complex, novel deals – some recent examples include multi-party, multi-product collaborations involving co-development, co-commercialization and exclusive supply arrangements.
Andres draws on his thorough knowledge of pharmaceutical, biotech and medical device operations and business practices to help clients shape deals, including applying his detailed knowledge of:
- Discovery and other pre-clinical activities, including involvement of universities and disease focused non-profits;
- Manufacturing technical operations, including formulation, process development, scale-up, site transfers, second sources, quality and regulatory demands placed on transactions;
- Clinical development operations and post-approval requirements;
- Commercial launch, marketing, promotion, distribution and sales;
- Intellectual property licensing;
- Evolving de-risking/risk sharing business strategies; and
- Coping with deal-related risks identified in non-public litigation.
Andres' practice is characterized by measured sensitivity to the many varied legal, regulatory and business risks relating to the activities contemplated by such deals, including substantive antitrust and healthcare regulatory hurdles and requirements, and navigating evolving HSR requirements, patent and other IP issues, as well as bankruptcy considerations. He flexibly partners with clients in a user-friendly manner, efficiently collaborating with each client’s internal resources and other external counsel to deliver a service that is not only conscious of the client’s internal processes and requirements, but also takes on the role that is desired by the client. While many times Andres serves as lead counsel on deals, he also provides advice behind the scenes and brings resources to help navigate clients through unfamiliar waters in deals they are executing.
Andres is recognized by Legal 500 US in the “healthcare and life sciences” category and as a “Life Science Star” in Euromoney’s LMG Life Sciences Guide. He has also been recognized in Who’s Who Legal’s The International Who’s Who of Life Sciences 2014, and he is recommended by PLC Which Lawyer as beiing among the leading lawyers throughout the US for Life Sciences: Commercial and Partnering.
Collaborations and Strategic Alliances
- Represented a Japanese pharmaceutical company in its multi-product co-development, co-commercialization arrangements with a major U.S. biotechnology company.
- Represented a German pharmaceutical company in its development, license and manufacturing arrangements with a U.S. biotechnology/medical device company for the commercialization of a drug-device combination.
- Represented a major pharmaceutical company in its in-license, development, manufacturing and commercialization arrangements with a Japanese pharmaceutical company.
- Represented a major pharmaceutical company in exclusive manufacturing and supply arrangements with a life sciences technology company.
- Represented a major pharmaceutical company in a licensing agreement with a publicly held research-focused biopharmaceutical company for its spinal muscular atrophy (SMA) program.
- Represented a major European pharmaceutical company in a $650M+ drug discovery partnership with a US biotechnology company.
- Represented a major pharmaceutical company in its multi-billion dollar multiproduct technology platform development collaboration and commercialization option arrangements with a biotechnology company.
- Represented a major European pharmaceutical company in a $500M+ development collaboration and commercialization option arrangement with a US biotechnology company.
- Represented a major India-based device and drug manufacturer in a series of development, license, manufacture and commercialization transactions with major healthcare device companies.
- Represented a leading private equity backed biotechnology company in several major deals with pharmaceutical partner companies.
- Represented a leading biotechnology company in the structuring of its novel complex commercial arrangements implicating difficult regulatory challenges.
- Represented a leading wound care company in its development, manufacturing and commercialization collaboration and license arrangements with a device manufacturer.
- Represented a major pharmaceutical company in a separate $250M+, $700M and $200M+ multiproduct development collaboration and commercialization option arrangements with biotechnology company partners.
- Represented a major branded India pharmaceutical company in several of its multiproduct complex strategic alliances on branded drug development with different major US pharmaceutical companies.
- Represented a specialty pharmaceutical company in its multiproduct development and commercialization collaboration with a technology platform biotechnology company.
- Represented a major China-based pharmaceutical company in its renegotiation of a collaboration with a US biotechnology company.
- Represented a biopharma medical device company in its strategic alliance for the development, manufacturing, supply and marketing collaboration with another biopharma medical device company.
- Represented a major pharmaceutical company in its multi-hundred million dollar “Rx-to-OTC switch” in-license transaction for a major drug going over-the-counter.
- Represented a major India-based pharmaceutical company in its collaboration with a European biotechnology company.
- Represented a European specialty pharmaceutical company in its collaboration with a major India-based pharmaceutical company.
- Represented a major biotech company in a series of challenging transactions to settle bet-the-company intellectual property litigations, clearing the way for the $6B+ M&A sale of the biotech company.
- Represented a major pharmaceutical company in its worldwide cross-license and settlement of interface actions with another major pharmaceutical company regarding their respective blockbuster products.
- Represented a major pharmaceutical company in several deal-related risk assessment analyses and successfully concluded resulting negotiations for the termination or renegotiation of complex contract arrangements, including in co-promotion arrangements, development collaborations and in-license deals.
- Represented a major pharmaceutical company in a challenging three-party contentious contract dispute matter, ensuing major litigation and three-way litigation settlement involving complex licensing and transfer of assets.
Life Sciences Mergers & Acquisitions
- Represented a major pharmaceutical company in its strategic divestment of two products, including negotiating the transition of the supply chains to the buyer.
- Represented a leading private equity backed specialty pharma company in its winning 363 stalking horse bid for the acquisition of two marketed pharmaceutical products out of the bankruptcy sale of another pharmaceutical company.
- Represented a specialty pharmaceutical company in its $400M+ acquisition of a therapeutic pharmaceutical product business and related assets.
- Represented a major pharmaceutical company in its strategic acquisition of a dermatology company.
- Represented a European vaccine company in its acquisition of vaccine assets.
- Represented a major biotechnology company in its $6B+ sale and merger with regard to life sciences and healthcare regulatory related matters.
- Represented a major pharmaceutical company in a $14B+ merger acquisition with regard to product liability, indemnification and insurance matters.
- Represented a major pharmaceutical company in its strategic divestitures of major consumer products.
- Represented a specialty pharmaceutical company in its $25M+ acquisition of Canadian rights to a biopharma medical device and related assets.
- Represented potential acquirers in numerous life sciences healthcare due diligence projects.
Operational, Marketing, Promotion and Sales Arrangements
- Represented major pharmaceutical and biotech companies in their companion diagnostic development deals.
- Represented a major pharmaceutical company in its complex marketing and promotion arrangements with a specialty pharmaceutical company.
- Represented a major pharmaceutical company with several complex manufacturing arrangements.
- Represented a specialty pharmaceutical company in its contract sales force arrangements with a biotechnology company.
- Represented a specialty pharmaceutical company in its promotional arrangements with its independently contracted sales force personnel.
- Represented pharmaceutical companies, medical device companies and biotechnology companies in hundreds of operational transactions supporting discovery, development, commercialization, distribution and marketing of life sciences products and technologies.