Novartis is required to produce the vaccine and to respect the agreement with the Ministry of Health. But only until it is deemed "reasonable." And again, if the serum vaccine is harmful to health "the Ministry is obliged to indemnify Novartis for any loss that the company is obliged to pay as a result of damage to persons or property caused by the product." In other words, if the vaccine is bad for those who assume the state pays. The corporation is liable only for manufacturing defects. Finally, if the product is not offered for failure to obtain authorization to trade and positive clinical trials, the Ministry is yet to pay. The lump sum is € 24 million net.
The contract between the pharmaceutical company and the Italian Government to deal with the possible pandemic of the H1N1 virus is no longer a secret. The site publishes the monthly Altreconomia, now that Ferruccio Fazio, Health Minister in question has announced that it has canceled half of the doses that should have received from Sanofi, which is 24 million.
far not had a clear idea on the number of doses of vaccine serum purchased from Novartis, delivery times, prices. The only thing of note with the multinational was that the ECA had 'rap' because the government guilty of agreeing terms too favorable to the company. Among these is the absence of penalties, the acquisition by the Ministry of risks and damages to the corporation for any losses.
The contract was signed August 21, 2009 between the Director General of the Ministry, Fabrizio Oleari, and CEO of Novartis Vaccines, Francesco Gulli. The text regulates the direct purchase of 24 million doses of vaccine. Cost: 184 million euro, VAT included. Of these were produced and consegante ten million doses. While those used are almost 900 000. The contract you can read and download, although there is the presence of deletions.
Article 1 states that Novartis is obliged to produce and to respect the contract, but only until it is 'reasonable'. Where to 'commercially reasonable efforts' is meant that the company is committed to fulfill the assignment, but when intervening 'factors are outside the full control of Novartis' agreement void, and the State pays the same (Article 3.1).
Among them: "The availability of eggs and other materials and the success of clinical trials necessary to support the features of safety and immunogenicity of the product."
The Box? Decide the company. Still, the ministry is not authorized to make any changes to the packaging or to obscure marks on it. Alter, obscure, remove or tamper with the trademark.
delivery and shipping. The multinational corporation - says in Article 3 - is committed to deliver within an agreed date the vaccine, but if it is unable to deliver the product simply a communication to the Ministry of seven days before the deadline to get a referral arrangement between the parties . And if the ministry had been unable to withdraw the product Novartis will sell it to another customer or bill the Department and not withdrawn, with the possibility however, after 90 days of selling.
Article 4: Guarantees and compensation. And if the vaccine is derived from the assumption of harm to health? The company is not responsible. Article 4.6 reads: "The Ministry shall indemnify, hold harmless and indemnify Novartis for any loss that the company is obliged to pay as a result of damage to persons or property caused by the product." In other words, if the vaccine is damaging the state pays. The corporation is liable only for manufacturing defects.
Price. The price for each dose of vaccine is 7 €. Total: 168 million euro plus vat. The Ministry must pay within 60 days from the issuance of bill, a current account of the Monte dei Paschi di Siena (Article 5).
Force Majeure. Ministry and company are not responsible for the one against the other if there are acts of God. Those that limit the liability of Novartis are extended to situations that should be guaranteed by Novartis, as epidemics and pandemics, "" acts of any governmental authority, "" acts of supranational institutions, such as the WHO (art. 8.3).
Term and Termination (9.3). In the event that the vaccine can not be delivered for failure to obtain authorization to trade and positive clinical trials, the Ministry is charged with Novartis a lump sum: 24 million euro net. And to close, in ten, the parties undertake to maintain absolute confidentiality of confidential information ..
Source: kataweb.it
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