The following changes have been made in the contract subsequent to your signature, incident to the addition of Article XI-Subcontracting Plan(s), to the Special Provisions. 1. The number of pages increased from 13 to 15. 2. Article XI-Subcontracting Plan(s), was added to the Table of Contents, Page 2. 3. The Manpower Reporting requirements, page 8, have been deleted; and replaced by the Federal Quarterly Individual Subcontracting Report and the Federal Quarterly Summary Subcontracting Report requirements. 4. In addition, these same reports have been added to Article IX-Additional Provisions and Other Attachments, page 12. 5. In Article VIII-Modifications to General Provisions, Clause No. 37, (Utilization of Small Business Enterprises) has been deleted; and the Clause, Utilization of Small Business Concerns and Small Business Concerns Owned and Controlled by Socially and Economically Disadvantaged Individuals, substituted therefor. 6. In Article X-Advance Understanding, an asterisk indicates which subcontracts are small business. 7. Finally, of course, Article XI-Subcontracting Plan (s), beginning page 13, has been added. I have initialled those changes which amend the provisions of the contract. Your organization is commended for having been the first, insofar as is known, to have accepted inclusion of provisions for implementation of Public Law 95507, in a research contract with a Government agency. I am personally indebted to all those at Brookdale who took part in the negotiations; but especially to Dr. Shapiro, Mr. Berkowitz, and Ms. Lawrence, for their patience, understanding, and endurance. It is apparent to me that Brookdale's acceptance of the lately imposed subcontracting provisions is motivated by more than mere acquiescence to yet another Government requirement; but rather stems from a working and humanitarian understanding of what the Government is trying to do in this regard to assist small business, and the socially and economically disadvantaged. Certainly, my attention to my other contracting responsibilities will be no less, but I look forward to the administration of this contract in the same spirit of courteousness and cooperation which typified its negotiation and award: With best wishes for the New Year, I am Sincerely yours, HARVARD GREGORY, Contracting Officer, Enclosure. 1. That it is, is not, a small business concern. If he is a small business concern and is not the manufacturer of the supplies to be furnished hereunder, he also represents that all such supplies will, will not, be manufactured or produced by a small business concern in the United States, its possessions, or Puerto Rico. (A small business concern for the purpose of Government procurement is a concern, including its affiliates, which is independently owned and operated, is not dominant in the field of operation in which it is contracting and can further qualify under the criteria concerning number of employees, average annual receipts, or other criteria, as prescribed by the Small Business Administration.) (See Code of Federal Regulations, Title 13, Part 121, as amended, which contains detailed definitions and related procedures.) 2. That it is a 3. That it is an NONPROFIT, of New York. REGULAR DEALER IN, MANUFACTURER OF, the supplies covered by this contract. INDIVIDUAL, STATE OR LOCAL AGENCY, PARTNERSHIP, JOINT VENTURE, EDUCATIONAL INSTITUTION, CORPORATION organized and existing under the laws of the state The Contractor agrees to furnish and deliver all the supplies and perform all the services set forth in the attached Special Provisions, for the consideration stated herein. The rights and obligations of the parties to this contract shall be subject to and governed by the Special Provisions and the General Provisions. To the extent of any inconsistency between the Special Provisions or the General Provisions and any specifications or other provisions which are made a part of this contract, by reference or otherwise, the Special Provisions and the General Provisions shall control. To the extent of any inconsistency between the Special Provisions and the General Provisions, the Special Provisions shall control. IN WITNESS WHEREOF, the parties hereto have executed this contract on the day and year last specified below. THE BROOKDALE HOSPITAL MEDICAL CENTER UNITED STATES OF AMERICA CONTRACT NO. NO1-AM-0-2216 SPECIAL PROVISIONS PAGE 3 OF 15 PAGES A. ARTICLE I DESCRIPTION OF WORK Independently, and not as an agent of the Government, the Contractor shall OBJECTIVES: The objective of this work is to study the safety and effectiveness of hemofiltration when the hemofiltrate is regenerated using a REDY type cartridge and reinfused into the patient (SRUF hemofiltration) STATEMENT OF WORK: IN VITRO STUDIES: The main purpose of this study phase is to determine the sodium release characteristics of the REDY D-32 cartridge after equilibration with sodium bicarbonate solution (156 mEq/1). Several solutions containing sodium, chlorine, bicarbonate and urea will be pumped in vitro through the cartridge and the outflow concentration of cations (including aluminum) and urea will be measured. ANIMAL STUDIES: The main purpose of this study phase is to study the potential toxicity clearance characteristics, and sterility of the system, and to develop safety features, set up a technique for human studies, and familarize personnel with the SRUF technique. Twenty-five uremic dogs will be treated 3 times, per week and autopsied. The animals will be treated with 0.5 M2 Amicon filters reused up to 6 times. Approximately 13 liters of hemofiltrate will be regenerated during each treatment, removing approximately 12 g of urea per treatment of approximately 3 hours each. The following outcome measurement will be performed on the first and third treatment: Hematocrit serum osmolarity, Ca, PO, uric acid glucose, electrolytes, BUN, and creatinine. Simultaneous levels of these substances will be measured in the hemofiltrate pre and post cartridge to determine clearances. During the last treatment blood levels of the following substances will be measured: PTH, GH, insulin, glucagon, renin, blood gases and pH. These levels will be also measured pre and post cartridge at 1, 2 and 3 hours. Exogenous clearances of inulin vitamin B12, and middle molecular weight peptides (500 - 1000 daltons) will be also obtained. These peptides will be obtained by Dr. Klein from dog's hemofiltrate and tagged with radioactive iodine at Gulf South Research Institute. Cardiovascular and hemotological studies will be also conducted during the animal studies. Cardiac output measurements will be conducted during nontreatment days Stevenson's bone marrow cell culture method will be used to EQUIPMENT: SRUF hemofiltration machines will be built for these studies by Extracorporeal Corporation. Two machines will be built during the first year and a third during the second year. PATIENT SELECTION AND EXCLUSION CRITERIA: Patients will be selected from the patient population undergoing hemodialysis treatment at the Brookdale Hospital Medical Center and, if necessary, at the Brooklin Kidney Center. The following criteria will be used for patient selection: (a) Renal disease as primary illness (b) Six month of prior hemodialysis, (c) Maximium of 5 ml/min of residual renal clearance, with an average of 3 (d) No severe intercurring systemic illness requiring hospitalization (f) Pretreatment BUN not varying more than 25% (g) Weight gain between treatment of 5 pounds or less (h) Vascular access free of infection, capable of providing a blood flow of 300 ml/min with a recirculation of less than 15% Patients will be excluded or may withdraw from this study for the following reasons: (a) Age greater than 60 or less than 20 years (b) Presence of malignancy, diabetes mellitus, hereditary disorders hypertension, familial hyperlipidemia, and/or symptomatic collagen-vascular (c) Avert cerebro-vascular disease (d) Bilateral nephrectomy (e) Poor compliance (f) Home dialysis (g) Any life threatening disorder other than renal failure (h) Patient preference Study Design: The following study design will be followed (including in vitro and animal studies): |