Grames Cunningham




GRAMES CUNNINGHAM & ASSOCIATES LLC is a partnership of two Principals who have many years of law and business experience in over 40 countries while serving in major law-firms, as in-house counsel in Fortune 50 companies, and in trade associations.

The Principals provide a full spectrum of legal and consulting services to mid-size international companies throughout the world either directly or through an extensive network of specialists (Associates) both in the United States and outside the United States. The firm has provided counsel and negotiating expertise for US domestic, international, and transnational matters in association with other law firms throughout the US and outside the United States, as well as with consultants and general service providers in areas such as M&A, R&D, marketing and sales, tax, manufacturing, IP, HR, accounting and finance, and government agencies (FDA, Commerce, Justice, etc., and regulatory agencies outside the United States).

The firm has particular expertise with: Japanese and Latin American language projects; and with life sciences products and organizations (pharmaceuticals, OTC medications, medical devices, nutritionals, nutraceuticals, cosmetics, and cosmeceuticals).

Below is a list of representative matters with which can assist you.

1. General legal affairs – United States and outside the United States:

  • Company organization and management (planning, corporate structure—C corporations, LLCs, partnerships, joint ventures—restructuring, consolidations, boards of directors, board meetings, minutes, etc.)
  • Subsidiaries, branches, and representative offices of foreign corporations in the U.S.
  • Establish of U.S. corporations overseas and management of foreign counsel
  • Corporate governance systems (codes of conduct, policies & practices for operations, training of personnel)
  • Company audits, financial and secretarial audits
  • Confidential investigation of internal irregularities
  • United States domestic and international tax planning and review of permanent establishment concerns
  • Registration of state incorporation and registration to do business in other states
  • Incorporation of foundations and other non-profit entities

2. Contract drafting, review, and advice regarding the following:

  • Confidential disclosure agreements (CDAs)
  • Preparing and responding to requests for proposal (RFPs)
  • Clinical trial and research agreements of all types including with contract research organizations (CROs), contract manufacturing organizations (CMOs), research institutions, contract sales organizations (CSOs), work orders, investigators, consultants, institutions, etc.
  • License of patented technology and other proprietary/confidential data and information
  • Real estate purchase and lease agreements; design and build agreements
  • Manufacturing agreements
  • Licensing and distribution agreements
  • Co-promotion and co-marketing arrangements
  • Joint ventures, partnerships, limited liability companies
  • Mergers, acquisitions, business development projects
  • Restructurings
  • Termination of agreements and disengagements

3. US and non-US government and regulatory agency advice and strategies of all types. Special experience in the life science area:

  • Negotiations with the FDA, CMS, EMA, and other agencies in Europe, Japan, etc.
  • Following and advice on new developments in laws and regulations
  • Disputes and litigation with government agencies
  • Compliance with trade regulations–FCPA and other anti-corruption laws, boycotts, specially designated nationals and companies, and technology export controls
  • Advertising, promotion, direct to consumer advertising advice
  • INDs, NDAs, ANDA’s, pediatric, and orphan drug status
  • Reimbursement
  • IRB and ethics committee policies and procedure
  • Advisory panels

4. Human resources advice:

  • Recruiting, terms of employment, dealing with prior employment
  • Employee relations and disputes
  • Employment agreements
  • Crisis management, including PR support
  • Severance planning and implementation – downsizing
  • Codes of conduct, United States and worldwide
  • Employee handbooks
  • Employee benefits, 401(k) regulations, etc.
  • Contracts with executive search and recruiting companies

5. Patents and patent strategy, trademarks:

  • Licensing
  • Patents, life cycle analysis, extensions
  • Trademark selection, protection, disputes, registration – worldwide
  • Trademark registration with pharmaceutical agencies, (FDA, EMA, etc.)
  • Domain names

6. Planning and executing commercialization, re-launching, etc., of new and existing products:

  • Longitudinal product evaluation based on patents, competitor products, new therapies, pricing restraints – United States, Europe, &/or worldwide
  • Developing strategies for launching/enhancing in-market awareness of a company/ product
  • In the life sciences area:
    • Life cycle management
    • Formulary inclusion
    • Pricing, reimbursement
  • Application for government grants

7. Litigation and dispute management:

  • Patent disputes
  • Contract disputes
  • Employee disputes
  • White collar crime
  • Tort claims (negligence, accidents, etc.)
  • Arbitration and mediation cases
  • Alternate dispute proceedings
  • Crisis planning and management
  • Disputes with tax authorities
  • Advising on appropriate liability and other insurance

8. Government affairs and lobbying:

  • Advise on new legislation, regulations, policies, and trends in government relevant to company business
  • Arrange meetings with legislatures and government agencies to understand and develop legislation, regulation, and policies
  • Follow activities of key trade associations (PhRMA, BIO, JPMA, etc.)
  • Public relations, public affairs, government affairs
  • US Trade Representative matters

9. Business development:

  • Provide introductions to a large network of potential partners and investors
  • Provide public affairs and public relations assistance
  • Developing names for pharmaceutical and other products acceptable for trademark and regulatory approval in relevant languages
  • Developing strategies for launching or enhancing in-market awareness of a company or its product
  • Mergers, acquisitions, joint ventures, joint operating agreements, dispositions, spin-offs, purchase and sales of assets, etc.
  • Managing accounting, finance, insurance, and tax experts

10. Introduction and management of third party professionals:

  • Accounting and tax experts
  • Human resource experts, recruiting employees, structures and particular employee packages from the CEO to medical, clinical, and regulatory experts — salary and employee benefits
  • Executive search and recruiting companies
  • In life sciences:
    • CROs, CMOs, and independent experts to manage clinical trials
    • CMC experts

11. International, between third countries, transnational:

  • Through our network of Associates, we also have experience in all the areas listed above outside of the United States, between third countries, and among multiple countries
  • We and our Associates have many years of United States and outside the United States experience – we have worked in over 40 countries worldwide and supervised work in over 70 countries. We are knowledgeable and sensitive to different cultures, business practices, and differing management styles in the business practices of different countries and differing management styles in different countries.