Katherine A. Gruner Counsel

Kae is a food and drug lawyer with a focus on advising pharmaceutical, medical device, cannabis, dietary supplement, food and beverage, and healthcare technology companies. She counsels clients on a range of intellectual property, regulatory, data privacy, corporate, and transactional matters.

Kae has substantial experience in developing intellectual property and commercialization strategies from bench-to-bedside, as well as in negotiating commercial agreements for life sciences companies. In addition, she counsels clients on compliance and interactions with FDA, DEA, HHS OIG, and FTC as it pertains to manufacture, marketing, and distribution of products regulated under the Federal Food, Drug, and Cosmetics Act.

In her most recent role as associate counsel for a pharmaceutical company and its subsidiaries, Kae served as the point person for all patent and trademark matters and held significant responsibility for drafting, reviewing, and negotiating contracts for all company affiliates, as well as policies relating to data privacy, licensing, and FDA regulatory compliance. Her experience gives her a unique insight into understanding both life science company compliance as well as transactions. As an in-house counsel she was actively involved in mergers, acquisitions, and capital acquisition with respect to her company’s growth and success.

Kae is a deal focused transactional lawyer with an in-depth understanding of funding and acquisitions in life sciences. She brings a skillset of understanding the transaction and the dual regulatory and intellectual property considerations for products in an acquisition.

Kae frequently speaks and writes about emerging healthcare, business, and technology topics. In addition to her current practice, Kae handles pro bono cases for artists, arts organizations, and early stage small business owners.

"I focus on understanding from the onset my life science client’s visions and alignment. By identifying and effecting practical and directed strategies that align with big picture vision, I achieve solutions that work from both a legal and a business perspective.”

Experience

Drafted legal opinions relating to patent validity and infringement positions with respect to prospective ANDA filings for a large generic pharmaceutical company.

Lead the regular legal review for all patent matters for a mid-sized pharmaceutical company and its affiliates, including patent freedom-to-operate reviews for prospective products (e.g. ANDA’s), as well as patentability, competitive patenting strategies, trademark eligibility, and copyright best practices.

Performed regulatory and IP due diligence reviews for high-stakes commercial transactions relating to corporate transactions, asset purchases, and IP licenses, including exclusive license and development agreements for a patent-protected peptide product for treating lupus (currently in Phase III clinical trial) and a patent-protected small molecule product for treating gout (FDA-approved).

Provided strategic advising and negotiation in royalty-bearing intellectual property licenses and asset purchase agreements for a mid-sized pharmaceutical company and its affiliates.

Oversaw label and labelling compliance for a pharmaceutical company and its active subsidiaries. Led the legal analysis and review for prescription and OTC drug products, cosmetics, and dietary supplements.

Negotiated pharmaceutical wholesale drug sale agreements, distribution agreements, and pharmaceutical supply agreements enabling sales teams to reach $300+ million sales targets.

Directed and lead FDA and intellectual property diligence team and review for the acquisition of all of company’s pharmaceutical targets. Experience handling both sell side and buyer transactions in life sciences.

Designed compliance program and effectuated the oversight and renewals of multiple pharmaceutical companies’ licensure submissions and renewals of licenses with state and federal governmental bodies.

Effectuated and supervised best practices and industry compliance for pharmaceutical company. Oversaw the completion of policies and procedures for alignments with Office of Inspector General (OIG) compliance.

Drafted letters of justification to DEA to support manufacturer’s procurement quota of the scheduled drug substance psuedoephedrine.

  • The University of Akron, Akron Law, LLM, Intellectual Property, 2013
  • The University of Akron, Akron Law, JD, cum laude, 2013
  • Hiram College, BA, Biology (with Honors) and Spanish, cum laude, Phi Beta Kappa, 2010

Member, Advisory Board, Georgia Lawyers for the Arts

Board Member, Metro Atlanta Association, Phi Beta Kappa

  • Speaker, "Surviving and Thriving in IP Due Diligence in Life Science Transactions," Surviving and Thriving in IP Due Diligence in Life Science Transactions, September 2021
  • Speaker, "Selecting Quality Outside Counsel for Patent Matters," IPWatchdog.com, February 2020
  • Speaker, "Legal Questions for Entrepreneurs," Break into Business Summer Camp, July 2017
  • Speaker, "Patents 101: Introduction to Patent Law," Georgia Lawyers for the Arts, August 2016
  • Speaker, "Trademarks for New & Emerging Businesses," Georgia Lawyers for the Arts, February 2016
  • Speaker, "Intellectual Property Law: 101," Phi Beta Kappa Society of Cleveland, February 2015
  • Guest Lecturer, "Patent Law & Engineering," Cleveland State University, College of Engineering, April 2014
  • Georgia
  • Spanish
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