Indemnified parties with a lot of bargaining power can claim damages for their own negligence and insist that the exception only applies to gross negligence. Although this is not contrary to public order, it is unusual for commercial contracts and is usually limited to certain sectors such as construction. Use our standard university compensation. See section 2.1. 11. Compensation – Two standard clauses: 1) for use in “off-label” clinical trial agreements (use of drugs NOT authorized by the FDA); 2) for use in “off-label” clinical trial agreements (FDA-approved use) of clinical trials. [This is mutual compensation for the negligence of each party and further provides that the Sponsor shall indemnify the University for claims arising from the use of the study results. It can only be used if the protocol or procedure used belongs to that of the university. The second paragraph (Sponsor`s compensation) may be used independently if the Sponsor does not ask us for compensation. If the sponsor provides drugs, equipment, etc., product liability may be more appropriate. With some minor changes, the first paragraph can be “mirrored” to create inter-agency (e.B. component-to-component) or mutual compensation from one state university to another.] A typical indemnification clause consists of two distinct obligations: an indemnification obligation and a defence obligation.
13.4 Under the System, the University is an agency of the State of Texas and is self-insured under the Professional Medical Malpractice Self-Insurance Plan under section 59.01 of the Texas Code of Education. The University will order and maintain adequate insurance during the term of this Agreement to cover its indemnification obligations under this Agreement. In the event that the representation of the indemnifiers and the sponsor by the same lawyer would constitute a conflict of interest for that lawyer, the indemnifiers may choose an independent lawyer without releasing the sponsor from his or her indemnification and defence obligations set out above. [This is a standard mutual compensation in which the university compensates the sponsor based on its negligence; The Sponsor shall indemnify the University for the University`s performance of the Protocol and the Sponsor`s use of the study results. It should be offered as the first position in terms of compensation if the unilateral compensation of the promoter to the institution has already been rejected by the promoter.] Covered events are certain types of events listed in the clearing clause. They may vary depending on the details of the transaction and are subject to negotiation. The most commonly covered events are: In each of the above cases, the indemnification clause protects the non-infringing party and makes it complete by requiring the injured party to cover the financial losses caused by it. Liability for claims for compensation should normally be unlimited, as it depends on the extent of the damage suffered by a third party. In the context of a contractual negotiation, however, you will try to limit or extend the scope of liability depending on the position.
NOTE: In certain unusual circumstances, it may be appropriate not to seek compensation from the proponent. Always consult the OGC on this conclusion and never offer this position; We should only accept this position in appropriate circumstances and only after any form of compensation by the sponsor, such as . B the above compensation for negligence was refused. Given (i) a protocol owned by us, (ii) a study drug used for an FDA-approved use, (iii) that almost every conceivable negligence would be on our part, and (iv) that injuries resulting from the drug itself would most likely result in liability claims for products against which the institution would be immune (the state would probably not waive sovereign immunity to it), minimal risk would not justify seeking compensation from the proponent. [13.1: This paragraph adds obligations to report and defend claims and cooperate. It may be added to any compensation at the request of the proponent or at the discretion of the component.] Most indemnification provisions require the indemnifying party to “indemnify and hold harmless” the indemnified party for certain liabilities. In practice, these terms are usually matched and interpreted as a unit to mean “remuneration”. 8. Indemnification – For use in patent and technology licensing agreements. Refundable damages are certain types of damages listed in the indemnification clause. These may vary and are negotiated by the parties. The main categories of recoverable damages are as follows: even a lengthy indemnification provision should only deal with certain issues: identification of the parties, determination of the extent of coverage, indication of conditions and exclusions, as well as discussion of the notification and defense of claims, etc.
An example of an unusual object in the context of a clinical trial would be a clause requiring us to compensate the sponsor for any damages they may suffer if it turns out that the intellectual property we give to the sponsor (which we are required to do under the intellectual property clause) infringes a patent. 10. Indemnification – This is a detailed and strictly negotiated remuneration that includes terms that should only be accepted if the sponsor firmly requests it. These conditions should be seen as examples of what is acceptable; however, every effort should be made to limit the number of conditions imposed. The development and negotiation of an effective indemnification provision benefits both the indemnified and the exempt party. A indemnification clause may allow for the following: For example, in a contract for the sale of goods, the risk that a product will harm a third party is borne more effectively by the seller than by the buyer. The seller has more control over the goods than the buyer, whose main obligation is payment. The seller is therefore in a better position than the buyer to mitigate losses and liabilities related to the goods. Subjects: legal provisions, contractual damages, contract negotiation, indemnification clause, indemnification 7. Indemnification – For use in material transfer agreements – University reception. Please refer to our Materiel Transfer Agreement Checklist for information on compensation and other issues that arise in this context.
[13.3: This paragraph on the promoter`s insurance coverage may be added to any indemnification.] 6. Indemnification – For use in material transfer agreements, academic transfer. 13.1 Obligations to notify and defend claims and to cooperate (may be added to any compensation at the request of sponsor or at the discretion of the Component). 13.2 Limited sponsorship compensation if the study drug is to be used in very dangerous procedures such as bone marrow transplantation. 13.3 Sponsor`s Insurance Coverage (may be added to any indemnification). 13.4 Self-insurance (may be added to any compensation). 13.5 If the Sponsor insists on a delay in its indemnification obligations. The full remuneration shall contain wording which is sufficiently broad to cover all other possible or explicitly covered lower types of compensation; Similarly, product liability and compensation for negligence expressly cover the lower use of compensation for results. The three aspects of this checklist are: There are four types of compensation that we regularly encounter in health-related sponsored research agreements. They are listed below, in order, from the least complete (most comprehensive coverage) to the most comprehensive (most comprehensive coverage): 5. Indemnification – A standard indemnity except that the sponsor limits its liability to claims for personal injury or death and imposes several conditions on its indemnification obligation: (1) proper conduct of the study, (2) notification and (3) right to control the defense. The exemption also gives the university the right to choose its own lawyer.
A indemnification clause is essentially an “I will protect your back” clause that makes the indemnification giver financially liable to the other party in the contract for amounts it may owe to a third party as a result of a breach of contract by the indemnitor. [This compensation applies to “off-label” use (use of drugs NOT approved by the FDA) for clinical trial agreements.] 1. What kind of compensation do you need? (What is the scope of coverage?) Set-off clauses can be found in almost all trade agreements. They are an essential tool for the allocation of risk between the parties and, as such, one of the most common and negotiated provisions of a contract. Given the level of potential third-party claims, it is important that customers play an active role in negotiating indemnification clauses. Take the time to consider the known business risks and think about “what could go wrong?” as part of the agreement….