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MARTIN MARIETTA ENERGY SYSTEMS, INC. Subject: Human Subjects Research In response to your questions concerning human subjects research. I am writing this memorandum to summarize the regulations regarding our distribution of radioactive materials and the collaborative studies of our ORNL Nuclear Medicine Program. The requirements for ordering a radioisotope from ORNL include completion, submission and approval of the attached DOE Form ER-391 and submission of a current license verifying that the institution can receive the Since ORNL is not licensed to distribute radioactive materials for human use, radioisotopes are explicitly shipped from ORNL with the understanding that they are not approved for human use, as described on the attached label which indicates the material is "Pharmaceutically Unrefined." Approval and liability for human use are the sole responsibilities of the institution receiving the radioisotopes. since the material was purchased from ORNL as "Unrefined." The physiciansponsored protocols for human use at the collaborating institutions require institutional and regulatory approval. In terms of our interaction with our Medical Cooperative Programs where ORNL radioisotopes are used for human use, we are not considered as "Principal Investigators." Please contact me if you require any further information or clarification of these points. Human Subjects Project
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This form is authorized b y the Atomic Energy Act of 1954 (Public Law 83-703), as amended. Previous Editions May (4-84) U.S. Department of Energy Not Be Used ISOTOPE AND TECHNICAL SERVICE ORDER FORM This form is to be used by a11 porsoru o t h r than Pedmral Aguacias or W I cost-type contractors ordaring byproduct m8teri8l. technical services. stable isotopes, or cyclotron-produced radioisotopes, or related services from the U. S . Department Of Energy. Submit in duplicate. (Use continuation sheet if required.) 1. TO: (Give name and address of facility from which materials or services will be obtained.) 12. BUYER'S ORDER NUMBER Accepted for the U.S. Department of Energy C/O Martin Marietta Energy Systems, Inc. Oak Ridge National Laboratory, Post Office Box 2009 9 . FROM: Name and address of buyer: 7 . MATERIAL OR SERVICE BYPRODUCT MATERIAL OR OTHER RADIOISOTOPE: State isotope, chemical form, desired TECHNICAL SERVICE State desired service. STABLE ISOTOPE: State isotope, chemical form, quantity, isotopic concentration total activity, specific activity. (specifying desired enrichment. minimum enrichment). WHICH IS AT ACHED HERETO IS MADE A PART OF THIS Technical Service Charge (if any) Handling Charge (if any) THIS ORDER IS SUBJECT TO THE TERMS AND CONDITIONS ON REVERSE SIDE 8 7 T h e undersigned certifies that he (it) is authorized to receive the above described byproduct material by: (Check block and o g h license number and expiration date if applicable.) &(a) UNRCor 0 License No. which expires
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TERMS AND CONDITIONS The order on the face hereof is placed in accordance with and subject to the following terms and condRlons 1 The term "buyec" as used herein means the person corporation. partnership. association. firm or other organzabon placing this order The term acbng on behalf of the Departmenr' includes employees and contractors of the Department. and employees of such contractors who till or participate in the filling of this order pursuant to their employment or their contracts wth the Department The term "Byproduct Material" as used herein means any radloactive matenal (except special nuclear matenal) yielded in or made radioactive by exposure to the radiabon incident to the process of produung or utiluing special nuclear matenal The term "DOE Facilrty" means a laboratory. plant, or office operated by or on behalf of the Department 2 The buyer understands and agrees that the Department may fuffill Its obligations under this order through the operator of any of lls facilttes 3 Materials and serves are furnished at p r e s and servce fees as fixed by the Department and in effect on the date of shipment of matenal or performance of the serves Prlces in catalogs issued by the Department or the operator of any facilty are subject to change without n o t e Payment for matenals and for servces rendered shall be made promptly upon receipt of billing in accordance with instrucbons furnished therewlth Payments recewed after 30 days from date of invoice may result in the billing. at the Departments opbon. of interest charges at the per-annum rate (365day basis) established from bme to bme by the Department for general applicatton to monies due the Department and so published in the federal Regfsler for past due accounts 4 VWmn shipment of matenal pursuant to this order requires the use of returnable Government-owned containers. title to such containers shall remain in the Government The buyer will keep the containers in good condibon, will not use them for any matenals other than the matenals shipped therein and will delwer them to a camer for return to the point of shipment. transportabon prepaid. wlthin 30 days from the date of receipt by fhe buyer of the shipment The buyer agrees lo pay to the Department a demumge charge on each returnable Govemment-owned container for that pew of retentm which IS in excess of fhe sard 3 M a y penod 5 Except as provlded in paragraph 7 as to matenal loaned or rented under this order. matenal covered by this order will be shipped f o b the DOE faulity from whlch the order is filled, provded. that in case of shipment by rail. f o b shall mean delwery to the nearest railhead of the transpomng Carner 6 Title to matenal sold under this order shall pass to the buyer when such materral IS delwered to the carrier 7 As to any matenal loaned or rented under this order (a) Title to any matenal procured on a rental or loan basis under this order shall remain in the Department. (b) Upon expiration or earlier termination of the loan or rental penod. as PrOVlded on the face of this order, the buyer shall return such matenal to the Department or deslgnated DOE facility. together w t h a statement describing use made of the matenal (c) Unless otherwise expressiy provlded for. on the face of this order, the buyer shall not expend. alter, destroy, contaminate. or dilute such matenal The buyer shall be responsible and shall reimburse the Department for any loss. contaminabon. dilmn. consumpbon of. or damage to. the matenal loaned or rented hereunder from the time of delwery of such matenal to the buyer until the material has been returned to the Department or designated DOE facilrty. or to a carner for such 8. Nelther the Government. the Department, nor persons acting on behalf of the Department makes any warranty or other representation. express or unplied, that (a) matenals accepted for a technical Service will not be destroyed. damaged, lost or otherwise altered in physical or Chemical properties in the process of performing the requested technical service, or that (b) matenals furnished under this order (1) will not result in injury or damage when used for purposes authorzed by the Department or for any other purpose or use, or (2) will accomplish the results for which they are requested or intended. 9. If the quanttty. quality, or physical or chemical properties. or form of material delwered under this order do not conform to the specifications set forth in item 7 on the face of this order the responsibility and liability of the Government, the Department, and of persons acting on behalf of the Department shall be limited solety to making reasonable efforts to correct such discrepancies by delivery Of matenal whch does conform to said specfications. The buyer agrees to report promptly any discrepancies between the materials supplied and that ordered SO that replacement or other appropriate adjustment may be made. The Department will reimburse the buyer for reasonable costs of packaging and transportabon incurred by the buyer in returning to the Deparbnant any material which does not conform to such speufications. 10. The Department will make reasonable efforts to perform services, or deliver material. at the time or times provided on the face of this order. but neither the Government. the Department. nor persons actrng on behalf of the Department shall be subject to any liability for failure to do so. 1 1 , Prior to delivery of matenal covered by this order, and upon timety request by the buyer, the Department will permit the buyer to cause said material to be tested or measured for conformty to specifications. 12. Unless otherwise expressly provided for in this order, materials supplied by the buyer for technical service. and analysis by the Department may be disposed of in accordance wlth the usual Department or DOE facili disposal procedures for radioactive matenals and the buyer shall have no claim for the value or replacement of materials thus disposed of, provided, when the materials supplied by the buyer are held or stored by the Department in accordance with instructrons of the buyer, or in order to protect health or to minimize other hazards to l i or property. the buyer will pay all storage charges connected therewlth. The buyer shall arrange for and bear the expenses of all other storage of such materials and the transportation of matenals which are not to be disposed of by the Department. 13 The Department reserves the right to cancel this order (a) in the event the buyers license (where applicable) is suspended, canceled, or revoked. or (b) when cancellatan of this order is determined to be necessary to the nabonal defense and secunty of the Unlted States 14 The Department shall have the nght to publish and use any informabon or data developed or produced by the Department or persons acbng on behalf Of the Department in Me course of or in connecton with the technical Servm. tesbng, or analysis of matenals or other services performed hereunder for the buyer. whether such matenals are furnished by the buyer or the Department 15 The buyer agrees to indemndy the Government. the Department and persons acbng on behalf of the Department against IiabiMy. including costs and expenses incurred. for infnngement of any Letters Patent occurnng in the course of the performance of any service. anatysis. or test perbonnad for me buyer as a result of following specfic instrucbons of the buyer in connecton therewlth. or occurnng in the ubluabon by the buyer of any matenal procured hereunder. pmvrded, that insofar as such matermls are prepared or used or services ut~lued in the performance of a Government contract, this indemnty agreement shall not appty unless such Government contract contains provisions mdemnffying the Government against patent infnngement 16 Data suppled on this form will be held confidenttal only to the extent that is determined to be wlthin the exemption for trade secrets and confidenttal commercml informabon as specfied in the Freedom of Inforrnabon Act 15 U S
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MARTIN MARIETTA ENERGY SYSTEMS, INC. WITH THE U.S. DEPARTMENT OF ENERGY) INTEREST, ADMINISTRATIVE CHARGES, AND PENALTIES ON PAST DUE INVOICES Martin Marietta Energy Systems, Inc., (Energy Systems) is a U. S. Department of Energy (DOE1 Management and Operating Contractor, as defined in the Federal Acquisitions Regulations, Subpart 1 7.6 - Management and Operating Contracts. As such, Energy Systems is a dedicated business unit established exclusively for the purpose of managing and operating certain production, fabrication and research facilities for the DOE. In this capacity, Energy Systems is required t o invoice and collect for any services, fabrication or research performed at the Government-owned, contractor-operated facilities, including work for other Federal agencies. All collections are deposited directly t o the U. S . Treasury. Any indebtedness is money due the United States Government. The collection of debt, including the assessment of interest, penalties and administrative charges, is governed by the provisions of the Federal Claims Collection Act of 1966 (31 U.S.C. 3701-37191, the Debt Collection Act of 1982 (Public Law 97-365), as amended, the revised Federal Claims Collection Standards (4 CFR 101-1051, and OMB Circular A-1 29. Energy Systems is the DOE'S agent in collecting amounts due the DOE for the following DOE facilities: Oak Ridge National Laboratory, Y-12 Plant, Oak Ridge Gaseous Diffusion Plant and Paducah Gaseous Diffusion Plant. Pursuant to the above laws and standards, payments not received within 30 days of the invoice date will be assessed interest on the amount due from the invoice date through the date of payment. A late payment handling charge shall be imposed on delinquent invoices for each 30-day period of delinquency or portion thereof. A penalty on any principal amount not paid within 90 days of the due date will be assessed from the date the debt becomes delinquent through the date of payment. Credit will be suspended and shipments will be stopped or services interrupted when an invoice is over 30 days past due. Interest and other late payment charges duly assessed are not waived by payment of principal. The collection actions, including the use of credit bureaus, administrative offset, holdup lists, suspension of eligibility, liquidation of collateral, collection agencies, or litigation, made available under the laws and standards cited above will be used as necessary to ensure the collection of the amount due. Interest rates, administrative charges and penalties are subject t o change. The current Interest Rate: 4 % per annum Administrative Charge per Delinquent Invoice per 30-day Period: $13.75" Penalty Rate: 6% per annum Interest and late charges do not apply to other Federal agencies and other management and operating contractors of the DOE, nor t o State and local governments and their agencies. Amounts received as partial payments will be applied first t o accrued penalties, then t o accrued administrative charges, then t o accrued interest, and finally t o the principal, pursuant t o 4 CFR 102.1 3(f). Address for Correspondence Regarding Invoices: Martin Marietta Energy Systems, Inc. Attention: Central Accounting Post Office Box 2003 Oak Ridge, Tennessee 37831-7057 By wire: By mail: MARTIN MARIETTA ENERGY SYSTEMS, INC. w FOR CREDIT FTB-KNOX Atlanta, Georgia 30384-0259 FOR FURTHER CREDIT MARTIN MARIETTA ENERGY SYSTEMS, INC. For amounts over $10,000, please use wire payments t o assure timely receipt. *Minimum charge. This amount does not include such charges as credit reports, court costs, attorney's fees and fees for outside collection agencies. These additional administrative costs will be assessed as incurred.