Contracts indemnities

Indemnity by the CRO or investigator in favour of the sponsor in respect of negligence, malpractice or breach of contract by the CRO or investigator. 

For the purpose of the indemnity provided in clause 5.2 above, the expression agents shall include, but shall not be limited to, any person providing services to the NHS Trust under a contract for services or otherwise. 

Setting up clinical studies is a lengthy process, as there are many documents to prepare [e.g. protocols and case report forms (CRFs)], study facilities to be assessed (e.g. study sites, CROs, clinical laboratories, phase I units), regulatory review to be considered and negotiations and agreements with study sites (e.g. contracts, finances, confidentiality, indemnity, insurance) to be undertaken. In addition, as will be dealt with in subsequent sections, ethical aspects of the study must be considered (e.g. ethics committee and IRB review and informed consent requirements), and study medications/devices must be organized. 

Many contracts or agreements must be prepared, understood and authorized before clinical studies begin. The most common contracts include the protocol and CRF agreements for finances, confidentiality, insurance and indemnity and contracts between the sponsor and the CRO. A separate investigator agreement, specifying all responsibilities, is usually necessary in addition to the protocol to emphasize certain aspects of the protocol. 

Generally, there is no contract between the pharmaceutical company and the patient who is prescribed the product by a doctor. In the United Kingdom, it has been held that where a product is prescribed under a National Health Service scheme, it is not prescribed as a result of a contract between the pharmaceutical company and the patient because legislation exists that requires a pharmacist to supply the product on the production of a valid prescription. For nonprescription, over-the-counter (OTC) products, there is a contract between the retailer and the consumer who purchases the pharmaceutical product, but there is still usually no direct link in contractual terms to the manufacturer of the product. It may be, however, that the contract between the manufacturer and the retailer contains an indemnity provision. Then, in the event of a successful claim for breach of contract made against the retailer by the customer, the manufacturer would effectively be required to reimburse the retailer for the amount ordered to be paid in compensation to the customer. 

The contract The contractual basis should be outlined in a letter of agreement . In addition to the undertakings relating to the particular trial, some standard provisions should be included either in the contract, in the protocol or in both. These include an indemnity statement, a study subject compensation statement, an inspection/audit understanding, and a publication statement. The investigators responsibilities under ICH GCP guidelines and related procedures should... 

Where consultants are involved in providing contracting services as well as consulting services, they must ensure that they have an adequate degree of insurance to cover both aspects of their work. Although not common, it is possible to obtain tailor-made policies that encompass the indemnification provisions of both a professional indemnity policy and a public liability policy providing the necessary degree of cover for pollution related claims. 

Compensation or indemnity which may be recovered in a judicial or quasi-judicial forum by a party who has suffered loss, damage, or injury, whether to person or property, through the unlawful act, breach of contract, omission, or negligence of another. Damages, Compensatory... 

A clause or provision in a life insurance or accident policy whereby the company agrees to pay the stated multiple (i.e., double, even triple indemnity is available) of the face amount in the contract in cases of accidental death. An accidental death is considered a death that is neither intentionally caused by a human being, such as murder or suicide, nor from natural causes, such as cancer or heart disease. In 2004, 4.67 percent of all deaths in the United States were declared accidental by the Centers for Disease Control and Prevention (CDC). Double-indemnity clauses are therefore usually relatively economical and often highly marketed, especially to people over 45 and under 60. Children and people in dangerous jobs, such as heavy construction, are the exceptions. 

In the contract for the Stanford study, the hidden cost multiplier was defined to account for all costs other than the direct compensation of the victim(s) —that is, other than for the indemnities paid to injured workers and the attendant medical costs. Hidden costs are ... 

The practical scope for a manufacturer or suppUer to exclude or restrict their liability under the Consumer Protection Act is very limited. According to Falla (1997), the only practical step which a manufacturer or supplier can take is to pass the buck by seeking an indemnity through contract from the person who supplied them. The person who is likely to end up with the liability is, therefore, the person at the beginning of the supply chain. 

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