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
Trademark registration with pharmaceutical agencies, (FDA, EMA, etc.)
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
Application for government grants
7. Litigation and dispute management:
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
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.