Pharmaceutical & Medical
Nctm assists Italian and international pharmaceutical and medical companies in ordinary and extraordinary transactions in all legal areas that converge into this sector (commercial and corporate advice, administrative and regulatory profiles, specialist contracts, compliance), both before the courts and out of court.
The practice areas of the team, which operates as part of the Commercial and Corporate Law Department, include:
- Joint ventures and extraordinary transactions with pharmaceutical companies;
- Project financing for hospital authorities;
- Investment in the national healthcare system, accreditation of healthcare facilities and medical centers, homecare services, indirect support, fees and reimbursements;
- Medical devices (pursuant to Italian Legislative Decree 46/1997);
- Drug marketing permits (autorizzazioni all’immissione in commercio di farmaci or AIC pursuant to Italian Legislative Decree 219/2006);
- OTC drug regulations (pursuant to Italian Legislative Decree 223/2006);
- Advertising and remote sales of drugs and medical devices;
- Factoring and securitizations relating to drug supplies;
- Pharma-related congresses and conferences;
- Sector-related organizational models and codes of ethics in application of Italian Legislative Decree 231/2001;
- Medical staff (remuneration of doctors in conflict of interest cases, authorizations, etc.) and nursing staff;
- Pharmaceutical representatives;
- Clinical trials and investigations regarding drug management, drug safety and health data processing.
Nctm Studio Legale has advised ALS Global Ltd (hereinafter “ALS”), an Australian multinational leader in the certification of products and services, in the acquisition of the entire corporate capital of Leochimica S.r.l. (hereinafter “Leochimica”), an Italian company engaged in the field of food and environmental safety.
By this transaction ALS has expended in the Life Science sector, extending its offer in the field of food and environmental certification.
ALS Global Ltd was advised by Nctm Studio Legale with a team led by Alice Bucolo and by Studio Havel, Holásek & Partners s.r.o. with a team led by Koval and Silvie Király.
Studio Bigattin Stefanuto e Associati has advised Leochimica S.r.l. with a team led by Tiziano Bigattin.
NCTM assisted Uriach, Spanish company leader in the pharmaceutical field, in the purchase of the majority stake in Laborest Italia S.r.l.
NCTM Team which has assisted Uriach in the transaction has been leaded by partners Lorena Possagno and Giuliano Lanzavecchia.
Italian port law prohibits a terminal operator from managing multiple areas for the performance of the same activities in one single port. We will first analyse how this prohibition could be amended following the recent 2016 reform.
Then we will look at a recent ruling of the Regional Administrative Court of Tuscany which clarified the obligations imposed on the Public Administration in the event of an expropriation of private areas in Italian ports.
The recent extension of the scope of the General Block Exemption Regulation (2014) to the granting of State aid to EU ports and airports reminds us of two recent judgments of the Court of Justice on State aid in the maritime sector and – in particular – the compensation of public service obligations to undertakings entrusted with the operation of services of general economic interest.
Next, we analyse two judgments from the United Kingdom and Spain concerning the application of two major international conventions in the field of international transport, the Hague-Visby Rules and CMR. The English verdict confirms that the failure to issue a bill of lading is not relevant in excluding the applicability of uniform legislation, whereas the Spanish ruling provides us with a definition of “default equivalent to wilful misconduct” for the purpose of excluding the limitation of carrier’s liability.
Moreover, the Italian Court of Cassation has issued two interesting decisions on transport matters. The Italian Supreme Court denied the holder of the bill of lading the right to act against a carrier for damage to the goods due to the lack of endorsement of the bill of lading by the receiver to the order of the holder, and considered an “exchange of containers” as a case of gross negligence of a road carrier.
Finally, let us analyse a decision of the Tax Court of Rome on IRESA, the noise emission tax in Italian airports. This ruling, in view of the fact that the Lazio Region disregarded the principles and aims set out in the national and European regulations concerning the use of the tax revenue, concluded for the disapplication of the IRESA as provided by the current regional legislation.
There’s a fair European wind blowing
Probably the most important outcome of the French election is not so much the actual electoral defeat of the National Front but the decision of that party to remove from its policy programme the idea of withdrawing from the Euro and promoting a referendum on Frexit. In other words, those parties which have based their political offer to the electorate on the negative impact of globalization and the hard impact of immigration, no longer see the solution as the break-up of the EU.
The same in happening in the Netherlands and even in the UK where the May government is promoting the need to address the negative aspects of globalization and migration in a substantive manner and not long saying that Brexit itself is the answer.
This is a window of opportunity that the EU must embrace. The underlying issues of migration and globalization must be addressed. But if they are addressed in a satisfactory manner the EU itself is not being challenged. There is a recognition in France and in the Netherlands, and even in Germany given the results in the recent Lander elections among the vast majority of the electorate that the EU remains a valid project and that the solutions are best found within its remit.
If Macron and Merkel can get together with the Italy and Spain, much can be done. From an insider’s point of view the only possible hiccup in catching this favourable wind is the capacity of the Commission to recognize it.
Alitalia insolvency: second round
By a decree of the Italian Ministry of Economic Development (MISE) on 2 May 2017 the extraordinary administration procedure set forth by legislative decree No. 347/2003 (“Legge Marzano”) was started for Alitalia Società Aerea Italiana S.p.A., which has also been declared insolvent by the Court of Civitavecchia on 11 May 2017.
Can the Court amend the concordato preventivo proposal upon confirmation?
The Court of Cassation with the decision of 3 April 2017, No. 8632 ruled that the confirmation order of the Bankruptcy Court can be appealed, even when there were no oppositions to confirmation, if the Court unilaterally amended the proposal approved by the creditors.
Is the bank liable for damages suffered by the insolvent company following directors’ reckless resort to credit lines ?
The decision of the Supreme Court of 20 April 2017, No. 9983 confirms that the bank can be held jointly liable with the directors towards the company, on different grounds from those making the bank accountable to individual creditors.
Grounds for ineligibility or forfeiture of statutory auditors who are members of an association of professionals
Pursuant to Article 2399, letter c), of the Italian Civil Code, statutory auditors whose patrimonial relationships with the company or its subsidiaries may affect their independence cannot be appointed and, if appointed, cease from their office. It has been questioned whether the case whereby a statutory auditor is a member of an association of professionals providing consultancy services to the same company reflects the case provided for by the law. Although the answer to the question was generally affirmative, doubts still remain as to the criteria adopted by the Supreme Court in order to determine the cases in which the independence of a statutory auditor can be actually considered as compromised.
The scope of the delegation of management in limited liability companies (s.r.l.): content and limits
By decision no. 25085 of 7 December 2016, the Supreme Court established the legitimacy of a general delegation of management, by the board of directors to individual managing directors with the power to act separately, to the extent that it is not aimed at excluding the exercise of a concurrent managing power by the managing body.
Data processing for marketing purposes: the protection of legal entities
By order No. 4 of 12 January 2017, the Italian Data Protection Authority set out the discipline on personal data processing for marketing purposes, finding the unlawfulness of both the processing of data collected through forms available on websites and the processing of data (namely, telephone numbers) autonomously collected on the Web.
Administrative liability of entities under Legislative Decree No. 231/2001 within groups of companies
Liability can be found, under Legislative Decree No. 31 of 2001, on the part of a holding company for offences committed in connection with the activities of its subsidiaries, provided that a) the person acting on behalf of the holding company acts in concert with the person committing the offence on behalf of the controlled entity; and b) the holding company appears to have obtained a concrete advantage from, or pursued an actual interest by way of, the offence committed in the context of the subsidiary’s activity.
The liability of non-executive directors and the duty to act in an informed way
According to decision no. 17441, of 31 August 2016, of the First Division of the Supreme Civil Court, the liability of directors without management power cannot originate from a general failure to supervise – that would be identified in the facts as a strict liability – but must be attributed to the breach of the duty to act in an informed way, on the basis of both information to be released by executive directors and information that non-executive directors can gather on their own initiative. Therefore, the determination of the prerequisites for the liability of delegating directors fits in a context accentuating the distinction between the duties imposed on managing directors and those typical of non-executive directors.
Considerations regarding the possibility to waive the termination effect of a notice to perform
Judgment No. 4205 of 3 March 2016 of the Supreme Court, Second Division, gives us the opportunity to provide a brief overview of the different opinions expressed by courts and legal commentators regarding the possibility to waive the termination effect of a notice to perform.
Validity of the shareolders’ agreements which provide a preventive waiver of the liability action against the directors when taken at the conclusion of the mandate
With the decision of 28th September 2015, No. 19193, the Court of Rome stated the validity of the shareholders’ agreement clauses which provide that the “incoming” shareholders undertake not to bring the liability action against the “outgoing” directors or not to vote for it in the general meeting.
The Supreme Court’s overruling: the banking and finance agreement signed exclusively by the client is null and void
The Supreme Court decides again the issue of the validity of the so called “single signature” agreements, i.e. the copy of banking and finance agreements, kept in the bank’s archives, bearing the client’s signature and not the bank’s one. The Supreme Court holds that these agreements are null and void, thus unenforceable vis à vis the account holder.
Purchase of shares of a general partnership: can the mistake on the value of the share be legitimately qualified as an essential mistake?
The Tribunal of Milan has stated that, as a rule – also with reference to the purchase of shares of a general partnership – the contract can be avoided, upon application of a party, for an essential mistake, only if the contract contains an explicit guarantee on the value of the assets and on the quality of the goods of the company (a guarantee that, according to the Tribunal, the contract at hand lacked).
The new rules regarding the proceedings before the Supreme Court (Decree Law n. 168/2016, converted into Law n. 197/2016)
With another “late summer intervention”, the legislator intervened once more as a matter of urgency to modify the code of civil procedure, with particular reference to the rules regarding the proceedings before the Supreme court: on August 31, 2016, Decree Law n. 168/2016 was published, entitled “Urgent measures for the resolution of disputes before the Supreme Court and for the efficiency of the judicial offices” (“D.L. 168/2016”).
The joined chambers of the court of cassation on the qualification and challenge of the non-final award and of the partial award
“An award that partially decides on the merits of a dispute, immediately challengeable pursuant to art. 827, paragraph 3 of the code of civil procedure, is both that of a generic condemnation pursuant to art. 278 of the code of civil procedure, and the award that decides one or some of the questions of the case, without defining the entire proceedings; instead, the awards that decide preliminary issues are not immediately challengeable.”