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The stronger version, the letter of comfort, indicates the parent organization's intention to support the subsidiary. [5] In the United States, there is a general presumption against the enforceability of letters of comfort. However, depending on the wording of the document, there may be legal liability under the rule of reliance. [6]
A comfort letter is a document prepared by an accounting firm assuring the financial soundness or backing of a company. [1] The comfort letter can be issued by a Certified Public Accountant declaring no indication of false or misleading information in the financial statements and that the company's prospectus follows the prevailing accounting standards.
The term pro forma (Latin for "as a matter of form" or "for the sake of form") is most often used to describe a practice or document that is provided as a courtesy or satisfies minimum requirements, conforms to a norm or doctrine, tends to be performed perfunctorily or is considered a formality.
For drug Warning Letters, the information in the above sections 1.6-1.8 and 1.10 is in closing paragraphs as follows (bold type indicates optional/alternative language to be used as appropriate): [3] The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist [ at your facility/in connection ...
Law portal; A side letter or side agreement or side letter arrangement is an agreement that is not part of the underlying or primary contract or agreement, and which some or all parties to the contract use to reach agreement on issues the primary contract does not cover or for which they require clarification, or to amend the primary contract.
Although a typical purchase order may not be worded as a contract (in fact most contain little more than a list of the goods or services the buyer desires to purchase, along with price, payment terms, and shipping instructions), the purchase order is a specially regarded instrument regulated by the Uniform Commercial Code or other similar law which establishes a purchase order as a contract by ...
The representations letter covers all periods encompassed by the audit report, and is dated the same date of audit work completion. It is used to let the client's management declare in writing that everything is MRL and is sufficient and appropriate and without omission of material facts to the financial statements, to the best of the ...
In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. [1]