Life sciences

 

De Gaulle Fleurance & Associés has profound expertise in all matters relating to life sciences. We are involved in both the pharmaceutical industry as well as in the cosmetic industry, chemical industry, hospitals and private health care institutions, investment funds or biotechnology companies. We address all matters, whether they are of a regulatory, contractual, corporate or litigious nature.

We are the only Parisian law firm to offer such a multitude of cross-practice skills in the interest of manufacturers, service companies or investors operating in the field of life sciences.

 

We have thus regularly worked in relation to the following issues:

  • We assist pharmaceutical laboratories in the context of the tax treatment and optimisation of pan-European medical research and the implementation of a transfer pricing policy in respect of research and development operations in different countries of the European Union.
  • We advise pharmaceutical companies with a view to determine their acquisition strategy (determining purchase price, structure definition, drafting and negotiation of the SPA, acquisition documentation).
  • We regularly create vehicles dedicated to welcome R&D, production, marketing activities among others. We provide upstream assistance with respect to corporate structure and governance rules according to our clients’ and their partners’ needs and cases’ particularities including in the event of a 100% control by the mother company of the original (public or private) structure or of a third party involvement. We also provide assistance in the follow up of these structures, especially concerning potential merges or acquisitions between groups, partnerships, and fundraising.
  • We assisted a world leader in the medical equipment sector in the setting up of a technological research institute (TRI) in partnership with industrials and other research institutes. More precisely, we advised them in choosing the best structure combining public and private actors, in drafting the application to the TRI call for projects launched by the National Research Agency in the context of the Grand Emprunt and in validating draft articles of incorporation and by-laws providing for governance principles and cross licenses to manufacture between founders and future partners concerning existing and new technologies.
  • We advised a French biotech leader in the genetic engineering sector and more particularly in the development of genetically modified animal models, in drafting and negotiating technological patent licenses with research centers or universities in France, the United States and Africa. We also assist this client in drafting and negotiating animal models development and marketing and genetic engineering servicing contracts.
  • We assist a professional union active in the medical products sector concerning regulatory matters, personal data protection and in the drafting of its code of ethics.
  • We advise and assist before the Council of State (Conseil d’Etat), a company specialized in the collection and treatment of medical data. This dispute initiated by a competitor aims at annuling the authorization delivered by the CNIL to use confidential data in order to provide studies about medical prescriptions and medicine consumption.
  • We assist a French pharmaceutical laboratory in the context of an administrative dispute relating to the cut in repayment rate for one of their products. In France, medicine prices are regulated. More precisely, the State, through an agency (Comité Economique des Produits de Santé et de l’Union Nationale des Caisses d’Assurance Maladie), sets the reimbursment rate of medicine, i.e., the part paid by the Social Security. In this matter, two proprietary drugs on the market for a while, were subject of a unilateral administrative decision aiming at lowering the said reimbursment rate. This kind of sovereign decision is extremely tough to contest before administrative judges who exercise a strict control.
  • We assist a leader in the plant protection sector in the context of a dispute initiated by a farmer complaining about various disturbances occuring in his corn crops after using several phytosanitary products distributed by our client. We had the plaintiff’s claim dismissed by the commercial court.