Contract amendments

Prepare a contract amendment procedure covering incoming and outgoing amendments. 

Do issue contract amendments on the same distribution list as the original contract. 

Don t imply acceptance of a change to contract in any communication other than a formal contract amendment. 

Pre-amendment To establish capacity to perform substantially changed tasks, sometimes needed if the contract, as discussed in Chapter 3, Mutual Agreements, Obligations, and Contract Considerations is undergoing revision. 

Are tenders, contracts, and subsequent amendments reviewed in accordance with documented procedures prior to submission or acceptance as appropriate ... 

The standard requires suppliers to identify how an amendment to a contract is made and correctly transferred to the functions concerned. 

Should the customer change the requirement, a new transaction will commence. (This new transaction is the method by which amendments to contract are made.)... 

Timely review means days, not weeks or months - therefore immediately a new customer document is received, it should be routed to a person authorized through procedures to carry out a review. It would be advantageous to set up an interface with your customers so that their documents are always routed to the same position in your company. The review should establish the applicability of the document and its impact on the contract. Any changed documents should be treated as an amendment to the contract and processed accordingly. 

In contract law, the acceptance of an offer must be unequivocal. Where a bid is accepted subject to an amendment on, say, program, the client is making a counteroffer, and the bidder then makes acceptance. 

The Study Director/Principal Investigator should ideally discuss all multi-site studies with QA personnel prior to study initiation (or prior to the issue of the protocol amendment if work is not detailed in the protocol). When acting as Study Director, a copy of the current GLP certificates should be requested from sub-contracted facilities and should be retained in QA. 

The Gouy-Chapman theory for metal-solution interfaces predicts interfacial capacities which are too high for more concentrated electrolyte solutions. It has therefore been amended by introducing an ion-free layer, the so-called Helmholtz layer, in contract with the metal surface. Although the resulting model has been somewhat discredited [30], it has been transferred to liquid-liquid interfaces [31] by postulating a double layer of solvent molecules into which the ions cannot penetrate (see Fig. 17) this is known as the modified Verwey-Niessen model. Since the interfacial capacity of liquid-liquid interfaces is... 

LBST (Ludwig-Bolkow-Systemtechnik GmbH) (1998). Identification of Hydrogen By-product Sources in the European Union, ed. Zittel, W. and Niebauer, P. (LBST), study funded by the European Commission under Contract No. 5076-92 11 EO ISP D Amendment No. 1. 

The products already on the market on 1 September 1971, the date for implementation of the Medicines Act, were given the Product Licences of Right (PLR) that were subject to a review process at a later date. This proposal for review of PLRs is reminiscent of the FDA contract with the National Academy of Sciences/National Research Council (NAS/NRC) in 1966, to evaluate the effectiveness of some 4000 different drug formulations approved on the basis of safety alone between 1938 and 1962 - the year of the Kefauver-Harris Amendment. 

Inquiries, contracts, or order handling, including amendments... 

Water Pollution Control Act of 1972, as Amended by Clean Water Act of 1977 , Environment Reporter, Fed Laws 71 (Dec 8,1978), 5101 ff 41) D.H.W. Liu et al, Toxicity of TNT Waste-waters to Aquatic Organisms. Vol I. Acute Toxicity of LAP Wastewater and 2,4,6-Trinitrotoluene , Final Rept, Contract DAMD 17-75-C-5056, SRI International, Menlo Park, Ca (1978) 42) H.V. Ellis et al, Mammalian... 

Abandoned or inactive sites in the USA are regulated through the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) or the Superfund, first signed in 1980 and reauthorized in 1986 in the Superfund Amendment and Reauthorization Act (SARA). Superfund Contract Laboratory Program (CLP) is a national network of EPA representatives, EPA contractors, and commercial environmental laboratories that support EPA s Superfund projects under... 

The final report and any amendments, all raw data, documentation, protocols and any amendments, and specimens (with the exception of specimens subject to degradation) generated as a result of a nonclinical laboratory study shall be retained in an archive. The archive facility needs to be set up for orderly storage and expedient retrieval. Conditions of storage shall minimize deterioration of the documents or specimens. The archives do not necessarily have to be an in-house facility the laboratory may contract with commercial archives to store materials in a GLP fashion. 

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