1. A contract is a legally enforceable agreement between two or more parties with mutual obligations. The remedy at law for breach of contract is "damages" or monetary compensation. In equity, the remedy can be specific performance of the contract or an injunction. Both remedies award the damaged party the "benefit of the bargain" or expectation damages, which are greater than mere reliance damages, as in promissory estoppels. We have the fact that when Robins & Robins contracted with Casings, Inc., they made sure to state in the section 14 B 2a that "The remedy for defects in supplies shall be limited to the cost of the parts supplied."
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The FDA shall be made a party to the proceeding; provided, that the court shall not have jurisdiction to hear any such petition for declaratory judgment, and no declaratory judgment may be rendered, unless the petitioner has first requested in writing that the sponsoring department pass upon the validity of the rule in question. Upon its receipt of any such petition the sponsoring department may elect to take no action other than to immediately refer the matter to the appropriate administrative appellate body with jurisdiction over the matter in question and request that such administrative appellate body respond to the petition on the department's behalf. In such a case, the administrative appellate body shall first determine whether it has jurisdiction over the referred matter and if so finding the administrative appellate body shall then pass upon the validity of the rule in question.
Robins can also argument the invalidity and have the regulation declared invalid and overturned would be if additional research were performed that presented a challenge or proved that there were flaws in the original research and results.
1/-The first ground on which to challenge an agency rule is that it is arbitrary, capricious, and abuse of discretion, or in violation of some other laws. This standard is generally applied to informal rulemaking and simply requires the agency to show evidence to support the proposed rule. Without such evidence, the rule can be held arbitrary and capricious.
2/-A second theory for challenging an agency`s regulation is that the regulation is unsupported by substantial evidence. This substantial evidence test is applied in the review of formal and hybrid rulemaking. Where the arbitrary and capricious standard simply requires some proof or basis for the regulation, substantial evidence requires that more convincing evidence exist in support of the regulation than against it.
3/- A third ground on which to challenge an agency`s regulation involves the rule that a regulation can be set aside if the agency did not apply with the APA requirements of notice, publication, and public comment or input. The procedures for rule making must be followed in order for the regulatory process and resulting rules to be valid. An agency that seeks public comment for the purpose of drafting legislation cannot then turn the legislation into rules after the comment period.
4/-Another basis for challenging a regulation is that the regulation is unconstitutional. Many challenges based on constitutional grounds deal with regulations that give an agency to search records or that impose discriminatory requirements for licensed professionals.
5/-Another theory for the challenging a regulation in court is ultra vires, a Latin meaning" Beyond it`s powers" An ultra vires regulation is one that goes beyond the authority given to the agency in its enabling act. Although most agencies stay clearly within their authority, if an agency tries to change the...