<PAGE>
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 29, 1997
-----------------
SERACARE, INC.
- -------------------------------------------------------------------------------
(Exact name of registrant as specified in its charter)
Delaware 0-21781 95-4343492
- -------------------------------------------------------------------------------
(State or other (Commission (I.R.S. Employer
jurisdiction of File Number) Identification
incorporation) Number)
1925 Century Park East, Suite 1970, Los Angeles, California 90067
- -------------------------------------------------------------------------------
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (310) 772-7777
--------------
Not Applicable
- -------------------------------------------------------------------------------
(Former name or former address, if changed since last report)
Total sequentially numbered pages in this document: 13.
<PAGE>
ITEM 2. ACQUISITION OR DISPOSITION OF ASSETS.
On November 29, 1997 (the "Closing Date") SeraCare Acquisitions, Inc. (SeraCare)
a Nevada corporation and a wholly-owned subsidiary of SeraCare, Inc. (the
"Company") acquired substantially all of the operating assets of American Plasma
Management, Inc., American Plasma Systems, Inc., and American Plasma Reno, Inc.
(collectively referred to as "Seller") consisting primarily of five operating
plasma collection centers located in Salt Lake City, Utah; Reno, Nevada;
Kalamazoo, Michigan; South Bend, Indiana; and Boise, Idaho, including inventory
on hand as of the Closing Date.
Under terms of the Asset Purchase Agreement dated November 29, 1997, the total
purchase price paid by SeraCare was $1,850,000, of which $1,250,000 was paid in
cash and $600,000 of which was in the form of a promissory note in favor of
Seller bearing interest at 8% per annum and due in one balloon payment no later
than October 31, 1998.
The operating assets acquired by SeraCare included furniture and equipment,
leasehold improvements, FDA licenses, and Donor Bases, medical supplies and
softgoods, and plasma inventories.
The purchase price was determined through arms length negotiations between the
Company and the Seller. In order to finance the acquisition and provide working
capital for the subsequent operation thereof, the Company interred into private
placement agreements for the sale of 329,896 shares of the Company's common
shares for $1,500,000. The private placement was made pursuant to a Regulation
D Offering in accordance with the exemption from registration under Section 4(2)
of the Securities Act of 1933, as amended (the "Act"), and Rule 506 of
Regulation D promulgated under the Act. In addition, the Company issued the
$600,000 promissory note in favor of the Seller bearing interest at 8% per annum
and due in one balloon payment no later than October 31, 1998.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(a) FINANCIAL STATEMENTS OF BUSINESS ACQUIRED
Audited financial statements of American Plasma Management, Inc.,
American Plasma Systems, Inc., and American Plasma Reno, Inc. for
the fiscal year ended October 31, 1997.
At this time, it is impractical to file the required financial
statements referenced above. Such financial statements will be
filed as soon as practical, but no later than 60 days after the
date on which this Report on Form 8-K is filed.
2
<PAGE>
(b) PRO FORMA FINANCIAL INFORMATION
At this time, it is impractical to file the required pro
forma financial information. Such data will be filed as
soon as practical, but no later than 60 days after the date
on which this Report on Form 8-K is filed.
(c) EXHIBITS
(2.1) Asset Purchase Agreement dated November 29, 1997 by and between
SeraCare Acquisitions, Inc. (as Buyer), and American Plasma
Management, Inc., American Plasma Reno Inc. and American Plasma
Systems, Inc., (as Seller)
3
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
SERACARE, INC.
Date: December 11, 1997 By: /s/ BARRY D. PLOST
---------------------- --------------------------------
Barry D. Plost
Chairman of the Board, President
and Chief Executive Officer
By: /s/ JERRY L. BURDICK
--------------------------------
Jerry L. Burdick
Executive Vice President and
Chief Financial Officer
4
<PAGE>
EXHIBIT 2.1
Asset Purchase Agreement dated November 29, 1997 by and between SeraCare
Acquisitions, Inc. (as Buyer), and American Plasma Management, Inc., American
Plasma Reno Inc. and American Plasma Systems, Inc., (as Seller)
5
<PAGE>
ASSET PURCHASE AGREEMENT
dated
November 29, 1997
by and between
SeraCare Acquisitions, Inc.
(as Buyer),
and
American Plasma Management, Inc.,
American Plasma Reno Inc. and
American Plasma Systems, Inc.,
(as Seller)
<PAGE>
TABLE OF CONTENTS
Page
----
ARTICLE I DEFINITIONS. . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Definitions. . . . . . . . . . . . . . . . . . . . . . . . 1
ARTICLE II SALE OF ASSETS, ASSUMPTION OF CERTAIN
LIABILITIES AND RELATED TRANSACTIONS . . . . . . . . . . . 1
2.1 Purchase and Sale of Assets. . . . . . . . . . . . . . . . 1
2.2 Assumption of Certain Liabilities. . . . . . . . . . . . . 2
2.3 Purchase Price . . . . . . . . . . . . . . . . . . . . . . 2
2.4 Continued Plasma Collection. . . . . . . . . . . . . . . . 2
2.5 Closing Cutoff Procedures. . . . . . . . . . . . . . . . . 2
ARTICLE III CLOSING. . . . . . . . . . . . . . . . . . . . . . . . . . 3
3.1 Closing Date . . . . . . . . . . . . . . . . . . . . . . . 3
3.2 Items to be Delivered at the Closing By
Seller . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3.3 Items to be Delivered at the Closing by
Buyer. . . . . . . . . . . . . . . . . . . . . . . . . . . 4
ARTICLE IV REPRESENTATIONS AND WARRANTIES OF
SELLER . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.1 Organization and Related Matters . . . . . . . . . . . . . 4
4.2 Authorization; No Conflicts. . . . . . . . . . . . . . . . 4
4.3 Financial Statements; Changes; Contingencies . . . . . . . 5
4.4 Tax and other Returns and Reports. . . . . . . . . . . . . 5
4.5 Assumed Contracts. . . . . . . . . . . . . . . . . . . . . 6
4.6 Title to and Condition of Purchased Assets . . . . . . . . 6
4.7 Leases; Real Property. . . . . . . . . . . . . . . . . . . 6
4.8 Legal Proceedings. . . . . . . . . . . . . . . . . . . . . 7
4.9 Insurance. . . . . . . . . . . . . . . . . . . . . . . . . 7
4.10 Permits. . . . . . . . . . . . . . . . . . . . . . . . . . 7
4.11 No Brokers or Finders. . . . . . . . . . . . . . . . . . . 7
4.12 Inventory. . . . . . . . . . . . . . . . . . . . . . . . . 8
4.13 Intellectual Property. . . . . . . . . . . . . . . . . . . 8
4.14 HBsAG Donors . . . . . . . . . . . . . . . . . . . . . . . 8
4.15 Operating Centers. . . . . . . . . . . . . . . . . . . . . 8
4.16 Owned Properties . . . . . . . . . . . . . . . . . . . . . 8
ARTICLE V PERMITS AND APPROVALS. . . . . . . . . . . . . . . . . . . 9
5.1 Permits and Approvals. . . . . . . . . . . . . . . . . . . 9
ARTICLE VI EMPLOYEES. . . . . . . . . . . . . . . . . . . . . . . . . 9
6.1 Employment Matters . . . . . . . . . . . . . . . . . . . . 9
ARTICLE VII POST CLOSING FURTHER ASSURANCES . . .. . . . . .. . . . . 10
7.1 Real Property Transfer Documentation . . . . . .. . . . . 10
7.2 Further Assurances . . . . . .. . . . . . . . . . . . . . 11
i
<PAGE>
Page
----
ARTICLE VIII TRANSACTION COVENANTS. . . . . . . . . . . . . . . . . . .11
8.1 Expenses and Taxes . . . . . . . . . . . . . . . . . . . .11
8.2 Allocation of Purchase Price . . . . . . . . . . . . . . .11
8.3 Bulk Sales . . . . . . . . . . . . . . . . . . . . . . . .11
8.4 Regulatory Inspections . . . . . . . . . . . . . . . . . .11
8.5 Leases and Amendments. . . . . . . . . . . . . . . . . . .12
8.6 Responsible Heads. . . . . . . . . . . . . . . . . . . . .12
ARTICLE IX INDEMNIFICATION. . . . . . . . . . . . . . . . . . . . . .12
9.1 Obligations of Seller. . . . . . . . . . . . . . . . . . .12
9.2 Obligations of Buyer . . . . . . . . . . . . . . . . . . .12
9.3 Procedure. . . . . . . . . . . . . . . . . . . . . . . . .12
9.4 Not Exclusive Remedy . . . . . . . . . . . . . . . . . . .13
ARTICLE X GENERAL. . . . . . . . . . . . . . . . . . . . . . . . . .13
10.1 Amendments; Waivers; Remedies. . . . . . . . . . . . . . .13
10.2 Entire Agreement; Construction . . . . . . . . . . . . . .13
10.3 Governing Law. . . . . . . . . . . . . . . . . . . . . . .14
10.4 Counterparts . . . . . . . . . . . . . . . . . . . . . . .14
10.5 Parties in Interest. . . . . . . . . . . . . . . . . . . .14
10.6 Notices. . . . . . . . . . . . . . . . . . . . . . . . . .14
10.7 Attorneys' Fees. . . . . . . . . . . . . . . . . . . . . .15
10.8 Severability . . . . . . . . . . . . . . . . . . . . . . .15
10.9 Arbitration. . . . . . . . . . . . . . . . . . . . . . . .15, 16
ii
<PAGE>
APPENDICES, EXHIBITS AND SCHEDULES
APPENDICES
- ----------
APPENDIX I - Definitions
EXHIBITS
- --------
EXHIBIT A - Purchased Assets
EXHIBIT B - Promissory Note
EXHIBIT C - Bill of Sale
EXHIBIT D - Assignment and Assumption Agreement
EXHIBIT E - Assignment and Assumption of Leases
EXHIBIT F - Letter Executed October 20, 1997 by and
Between Daniel Idema and Joseph Rosen
SCHEDULES
- ---------
Schedule 2.2 Assumed Liabilities
Schedule 4.2 - Permits and Approvals
Schedule 4.3 - Financial Statements
Schedule 4.5 - Assumed Contracts
Schedule 4.6 - Title to and Condition of Purchased Assets
Schedule 4.7 - Leases; Real Property; Title Policy
Schedule 4.13 - Intellectual Property
Schedule 6.1 - Excluded Employees
iii
<PAGE>
ASSET PURCHASE AGREEMENT
THIS ASSET PURCHASE AGREEMENT (this "AGREEMENT") is entered into this
29th day of November 1997, by and between SeraCare Acquisitions, Inc., ("BUYER")
on the one hand, and American Plasma Management, Inc., American Plasma Reno,
Inc. and American Plasma Systems, Inc., (collectively the "SELLER") on the other
hand. Seller is engaged in the business of collecting, analyzing, processing and
selling human blood plasma and other human biological products or components and
the operation of plasma collection facilities for the conduct of such business
(the "BUSINESS") located at 705 North Park Street in Kalamazoo, Michigan; 515
Lincoln Way West in South Bend, Indiana; 606 West North Temple in Salt Lake
City, Utah; 785 East 2nd Street in Reno, Nevada; 1021 Broadway Avenue in Boise,
Idaho (collectively, the "CENTERS"), and desires to sell certain related assets
and cause Buyer to assume certain liabilities. Buyer desires to purchase certain
assets and assume certain liabilities of Seller on the terms and conditions set
forth in this agreement. In consideration of the mutual promises contained
herein and intending to be legally bound, the parties agree as follows:
ARTICLE I
DEFINITIONS
1.1 DEFINITIONS. For all purposes of this Agreement, except as
otherwise expressly provided or unless the context otherwise requires, the
capitalized terms in this Agreement shall have the meanings assigned to them in
Appendix I attached hereto which is incorporated herein by reference.
ARTICLE II
SALE OF ASSETS, ASSUMPTION OF CERTAIN LIABILITIES
AND RELATED TRANSACTIONS
2.1 PURCHASE AND SALE OF ASSETS. Subject to the terms and conditions
of this Agreement, on the Closing Date, Seller shall sell, convey, assign,
transfer and deliver to Buyer (or its designee), and Buyer (or its designee)
shall purchase, acquire and accept from Seller, all of the assets, properties,
rights, privileges, claims and rights of every kind and nature, tangible and
intangible, absolute or contingent, used by Seller in connection with the
Centers (the "PURCHASED ASSETS"), which Purchased Assets shall include, but not
be limited to, the items set forth on Exhibit A attached hereto; provided,
however, notwithstanding anything to the contrary contained in this Agreement,
title to the Owned Properties shall only transfer to Buyer in accordance with
the provisions of Section 7.1 hereof.
<PAGE>
2.2 ASSUMPTION OF CERTAIN LIABILITIES.
Upon the terms and subject to the conditions contained herein, on the
Closing Date Purchaser shall assume only those liabilities listed on Schedule
2.2 and liabilities for supplies explicitly approved in writing by Buyer (the
"ASSUMED LIABILITIES"). Except for the Assumed Liabilities, Buyer shall not
assume, shall not take subject to and shall not be liable for, any liabilities
or obligations of any kind or nature, whether absolute, contingent, accrued,
known or unknown, of Seller or any affiliate of Seller, including, but not
limited to, any liabilities or obligations with respect to (i) Seller's Business
prior to the Closing Date, (ii) employees of the Business and (iii) under any
employee benefit plans (the "EXCLUDED LIABILITIES").
2.3 PURCHASE PRICE AND PAYMENT OF PURCHASE PRICE. The total purchase
price (the "PURCHASE PRICE") to be paid to Seller by Buyer shall be $1,850,000,
$500,000 of which has already been paid to Seller and $1,350,000 of which is due
at Closing. Of the $1,350,000 due at Closing, $750,000 shall be paid in the form
of a certified check or wired funds upon Closing or on December 1, 1997,
whichever comes later, and $600,000 shall be paid in the form of a promissory
note of Buyer's parent company, SeraCare, Inc., in the form of Exhibit B hereto
in favor of Seller bearing interest at a rate of 8% per annum and due in one
balloon payment no later than October 31, 1998.
2.4 CONTINUED PLASMA COLLECTION. Buyer and Seller agree to continue
cooperating on a best efforts basis to minimize the cost to Seller of collecting
plasma at the Centers from November 14, 1997 to the Closing Date. Seller agrees
to implement whatever operational measures Buyer instructs it to take in this
regard; and in return, Buyer agrees to reimburse Seller at a rate of $50 per
unit of plasma that is collected and tested. The provisions in this Section
shall have effect from November 15, 1997 until the Closing Date. Buyer may, at
its sole option, elect to delay the testing of plasma units collected by Seller
during this period. If Buyer makes this election, Buyer and Seller agree the
reimbursement rate for such untested plasma will be $37 per unit instead of $50
per unit. The value of reimbursements shall be in addition to the Purchase Price
as set forth in Section 2.3. Buyer shall reimburse Seller for the cost of
softgoods purchased at the request of Buyer but not used in the collection of
plasma on behalf of Buyer. Amounts payable under this Section 2.4 shall be paid
within five business days of the Closing Date. Title to the additional plasma
will transfer to Buyer upon payment.
2.5 CLOSING CUTOFF PROCEDURES. Buyer agrees to reimburse Seller on
December 1, 1997, for the cash balances in the bank accounts relating to the
Centers minus the amount of any checks or other drafts written against such cash
balances or any
2
<PAGE>
other withdrawals or reductions of such cash which have not yet cleared the
accounts or otherwise been reflected therein. Buyer and Seller agree to
cooperate with respect to the payment of accounts payable and trade payables
after the Closing Date. Buyer and Seller agree that payables relating to periods
prior to December l, 1997 shall be borne by Seller and payables relating to
periods after November 30, 1997 shall be borne by Buyer. Payables that relate to
periods both before December 1, 1997 and after November 30, 1997 shall be
prorated between Seller and Buyer as appropriate to account for the number of
days to which the payables relate that are before December 1, 1997 and the
number of days that are after November 30, 1997, respectively. If either party
pays a payable (the "PAYING PARTY") that is required to be borne by the other
party (the "REIMBURSING PARTY") pursuant to this Section 2.5, then the
Reimbursing Party, within five business days of a written request therefor from
the Paying Party, shall send a check to fully reimburse the Paying Party for the
amount paid with respect to such payable.
ARTICLE III
CLOSING
3.1 CLOSING DATE. Subject to the satisfaction or waiver by the
appropriate party of all the conditions precedent to closing specified in
Article VIII hereof, the Closing shall take place at the offices of O'Melveny &
Myers LLP, 610 Newport Center Drive, Suite 1700, Newport Beach, California, at
6:00 p.m. Pacific Standard Time on November 29, 1997, or at such later date or
at such other location as the parties hereto may mutually designate in writing
(the "CLOSING DATE") . Either party may elect to effect the Closing via the
exchange of executed documents and certificates by telecopier or overnight mail.
Promptly after the Closing, Seller shall prepare a consolidated balance sheet
and related notes of the Centers as of the close of business on the Closing
Date. Buyer shall give representatives of Seller access to the books and records
of the Business for purposes of preparing such balance sheet.
3.2 ITEMS TO BE DELIVERED AT THE CLOSING BY SELLER. At the Closing,
Seller shall deliver or cause to be delivered to Buyer (a) a Bill of Sale and an
Assignment and Assumption Agreement in the form of Exhibit C and Exhibit D,
respectively, (b) Assignment and Assumption of Leases in the form of Exhibit E
(and related estoppel certificates from lessors) with respect to the Leases,
together with any necessary consents of the lessors, (c) such other instruments
of transfer necessary or appropriate to transfer to and vest in Buyer all of
Seller's right, title and interest in and to the Purchased Assets and (d) the
keys/combinations to all locks located on or in the Purchased Assets (and any
and all cards, devices or things necessary to access any of the Purchased
Assets) shall be surrendered on request to Buyer's representatives at the
facilities where such
3
<PAGE>
assets are located. Simultaneously with the deliveries referred to in this
Section, Seller shall take or cause to be taken all such actions as may
reasonably be required to put Buyer in actual possession and operating control
of the Purchased Assets.
3.3 ITEMS TO BE DELIVERED AT THE CLOSING BY BUYER. At the Closing,
Buyer shall deliver or cause to be delivered to Seller (a) payment of the
Purchase Price, (b) the Assignment and Assumption Agreement, (c) the Assignment
and Assumption of Leases, and (d) the certificates, consents and other documents
referred to herein as then deliverable to Seller.
ARTICLE IV
REPRESENTATIONS AND WARRANTIES OF SELLER
Seller represents, warrants and agrees as of the date hereof and as of
the Closing Date (except as otherwise indicated) as follows:
4.1 ORGANIZATION AND RELATED MATTERS. Each Seller is a corporation
duly organized, validly existing and in good standing under the laws of its
jurisdiction of incorporation. Each Seller has all necessary corporate power and
authority to (i) execute, deliver and perform this Agreement and any related
agreements to which it is a party, (ii) own its properties and assets and (iii)
carry on the Business as now conducted. Each Seller is not required, by reason
of its operation of the Business, to be qualified or licensed to do business as
a foreign corporation in any jurisdiction in which it is not so qualified or
licensed.
4.2 AUTHORIZATION; NO CONFLICTS. The execution, delivery and
performance of this Agreement by each Seller has been duly and validly
authorized by the Board of Directors of such Seller and by all other necessary
corporate action on the part of such Seller. This Agreement constitutes the
legally valid and binding obligation of each Seller, enforceable against such
Seller in accordance with its terms except as such enforceability may be limited
by bankruptcy, insolvency, reorganization, moratorium and other similar laws and
equitable principles relating to or limiting creditors rights generally. Subject
to obtaining all Approvals, the execution, delivery and performance of this
Agreement, any related agreements or contemplated transactions by each Seller
will not (with the passage of time, notice or both) violate, or constitute a
breach or default under, the charter documents or bylaws of such Seller, any
Assumed Contract of such Seller, result in the imposition of any Encumbrance
against any of the Purchased Assets or violate any law applicable to such Seller
or the Business. SCHEDULE 4.2 lists all Permits and Approvals required to be
obtained by each Seller to consummate the transactions contemplated by this
Agreement. Except for matters identified on SCHEDULE 4.2 as
4
<PAGE>
requiring that certain actions be taken by or with respect to a third party or a
governmental entity, the execution and delivery of this Agreement by each Seller
and the performance of this Agreement and any related or contemplated
transactions by such Seller will not require filing or registration with, or the
issuance of any Permit by, any other third party or governmental entity under
the terms of any applicable laws or contracts to which such Seller is a party.
4.3 FINANCIAL STATEMENTS; CHANGES; CONTINGENCIES
4.3.1 FINANCIAL STATEMENTS. The unaudited balance sheets provided
to Buyer and identified on SCHEDULE 4.3 (the "FINANCIAL STATEMENTS"), have been
derived from the books and records of Seller, which are maintained on a
consistent basis from period to period, have been prepared in accordance with
GAAP applied on a consistent basis and fairly present the financial condition
and results of operations of the Business as of and for the periods indicated.
The Financial Statements reflect all adjustments necessary for a fair
presentation of the information contained therein, except as specified therein.
Since September 30, 1997, there has been no change in any of the significant
accounting policies, practices or procedures of Seller with respect to the
Business.
4.3.2 NO MATERIAL ADVERSE CHANGES. Except as set forth on SCHEDULE
4.3, since September 30, 1997, there has not been, occurred or arisen:
(a) To the best of Seller's knowledge, any change in or event
affecting the Business, the Purchased Assets, the Assumed Contracts or the
Assumed Liabilities that has had a material adverse effect on the Business or
the Purchased Assets, the Assumed Contracts or the Assumed Liabilities; or
(b) Any transaction entered into or carried out other than in the
usual and ordinary course of the Business.
4.3.3 NO OTHER LIABILITIES OR CONTINGENCIES. There are no material
liabilities of any nature, whether accrued, absolute, contingent or otherwise,
and whether due or to become due, probable of assertion or not, relating to the
Business, except liabilities that (a) are reflected or disclosed in the
Financial Statements, (b) were incurred after September 30, 1997 in the ordinary
course of the Business or (c) are set forth in the Schedules.
4.4 TAX AND OTHER RETURNS AND REPORTS. Seller has timely filed or will
file all required tax returns and has paid or will have paid all Taxes due with
respect to the Business and the Purchased Assets for all periods ending on or
before the Closing Date. There are no Encumbrances with respect to Taxes upon
any of the Purchased Assets or the Business, except
5
<PAGE>
Encumbrances for current Taxes (including tangible personal property taxes) not
yet due. All required tax returns relating to the Business, including amendments
to date, have been prepared in good faith without negligence or willful
misrepresentation and are complete and accurate in all material respects.
4.5 ASSUMED CONTRACTS. SCHEDULE 4.5 identifies each Assumed Contract
(other than the Leases) by date, parties signatory thereto and subject matter.
The Assumed Contracts include each contract upon which the Business is
substantially dependent and each contract which is otherwise material to the
Business or the Purchased Assets. True, correct and complete copies of the
Assumed Contracts, including all amendments and supplements, have been delivered
to Buyer. Each Assumed Contract is valid and subsisting and, upon assignment
pursuant to this Agreement, will be enforceable by Buyer, except as
enforceability may be limited by bankruptcy, insolvency, reorganization,
moratorium and other similar laws and equitable principles relating to or
limiting creditors' rights generally; there is no litigation pending or, to
Seller's knowledge, threatened by any party with respect to any Assumed
Contract; Seller has duly performed all its material obligations thereunder to
the extent that such obligations to perform have accrued; and no breach or
default, alleged breach or default, or event which would (with the passage of
time, notice or both) constitute a breach or default thereunder by Seller has
occurred or as a result of this Agreement or its performance will occur
(assuming receipt of all required Approvals). Except as set forth on SCHEDULE
4.5, consummation of the transaction contemplated by this Agreement will not
(and will not give any person a right to) terminate or modify any rights of, or
accelerate or augment any obligation of, Seller under any of the Assumed
Contracts.
4.6 TITLE TO AND CONDITION OF PURCHASED ASSETS. Except as set forth
on SCHEDULE 4.6, Seller has good and marketable title to each of the
Purchased Assets, free and clear of any Encumbrances. Seller has all right,
power and authority to sell, convey, assign, transfer and deliver the
Purchased Assets to Buyer in accordance with the terms of this Agreement. The
equipment included in the Purchased Assets is in good condition and repair.
4.7 LEASES; REAL PROPERTY. SCHEDULE 4.7 identifies each Lease by date,
parties signatory thereto and property description or address. The Leases are
valid, binding and enforceable, except as may be limited by bankruptcy,
insolvency, reorganization, moratorium and other similar laws and equitable
principles relating to or limiting creditors' rights generally. Each of the
Leases constitutes the entire agreement to which Seller is a party with respect
to the subject property which is demised pursuant thereto. All conditions
precedent to the enforceability of the Leases have been satisfied and there
exists no breach or default, nor state of facts which, with the passage
6
<PAGE>
of time, notice, or both, would result in a breach or default on the part of
either Seller or the lessor thereunder. All space and improvements leased by
seller have been fully and satisfactorily completed and furnished in accordance
with the provisions of the Leases. SCHEDULE 4.7 identifies the Real Property by
property description and address. Seller has good and marketable fee simple
title to all Real Property subject to the state of facts set forth in SCHEDULE
4.7, including the title commitment attached as a part of SCHEDULE 4.7. Seller
has received no written notice of noncompliance with any restriction encumbering
any Real Property, nor has Seller received written notice of any zoning
violations affecting any Real Property. To the best of Seller's knowledge, there
is no pending or threatened Action that would materially interfere with the
quiet enjoyment of any such Real Property by Seller or, after the Closing, by
Buyer. Except as otherwise set forth in SCHEDULE 4.7, there are no leases,
subleases, licenses, occupancy agreements, options, rights, concessions or other
agreements or arrangements, written or oral, granting to any person the right to
purchase, use or occupy any of the Real Property, any of the facilities located
on the Real Property or any portion thereof or interest therein.
4.8 LEGAL PROCEEDINGS. There is no Order or Action pending, or, to
the best knowledge of Seller, threatened, against or affecting Seller or any
aspect of the Business that individually or when aggregated with one or more
other Orders or Actions has, or if determined adversely might reasonably be
expected to have, a material adverse effect on the Business, the Purchased
Assets (or the use, operation or value thereof), the Assumed Contracts, the
Assumed Liabilities, Seller's ability to perform this Agreement, or any aspect
of the transaction contemplated by this Agreement.
4.9 INSURANCE. Seller is, and at all times during the past five
years has been, insured with reputable insurers against all risks involving the
Business normally insured against by companies in similar lines of business. All
of the insurance policies and bonds maintained by Seller with respect to the
Business are in full force and effect and Seller is not in default under any
such policy or bond.
4.10 PERMITS. Seller holds all material Permits that are required
by any governmental entity to permit it to conduct the Business as now conducted
and operate the Purchased Assets as they are now operated, and all such Permits
are valid and in full force and effect and will remain in full force and effect
upon consummation of the transactions contemplated by this Agreement. All such
Permits will be included with the Purchased Assets.
4.11 NO BROKERS OR FINDERS. No agent, broker, finder, or investment
or commercial banker, or other person or firm engaged by or acting on behalf of
Seller or any affiliate in connection with the negotiation, execution or
performance of this
7
<PAGE>
Agreement or the transaction contemplated by this Agreement, is or will be
entitled to any brokerage or finder's or similar fee or other commission as a
result of this Agreement or such transaction.
4.12 INVENTORY. The value at which Inventories are carried reflects
the customary inventory valuation policy of Seller (which fairly reflects the
value of obsolete, spoiled or excess inventory) for stating inventory, in
accordance with GAAP consistently applied. As of November 14, 1997 Seller has
been inventorying approximately 12,600 liters of source plasma in the Centers,
and acknowledges that these are specifically included in the Purchased Assets
and accounted for in the Purchase Price.
4.13 INTELLECTUAL PROPERTY. SCHEDULE 4.13 lists all intellectual
Property relating to the Business in which Seller has an interest and the nature
of such interest. Seller has complete rights to and ownership of all
Intellectual Property required for use in connection with the Business. The
Intellectual Property of Seller is fully assignable free and clear of any
Encumbrances.
4.14 HBsAg DONORS. Seller's present program with respect to drawing
plasma from two specific human donors reactive for HBsAG is a material component
of the transaction. Its value is accounted for in the Purchase Price.
4.15 OPERATING CENTERS. All Centers are presently operating and have
not shut down, ceased operating, or lost their prospective ability to operate
for any reason, including loss of license or regulatory approvals.
4.16 OWNED PROPERTIES. Seller is the sole owner of the Owned
Properties and has good, valid and marketable title to the Owned Properties free
and clear of all liens, encumbrances, rights, reservations, easements and other
exceptions of record. Without limiting the foregoing, there are no federal,
state or local tax liens encumbering Seller's interest in any of the Owned
Properties. There are no violations of any covenants, conditions or restrictions
applicable to the Owned Properties, and Seller has received no notice or
complaint with respect to any violation of any covenants, conditions or
restrictions applicable to any of the Owned Properties. The use, operation and
sale of the Owned Properties is in compliance with applicable building codes,
environmental, zoning, subdivision, and land use laws, and other applicable
local, state and federal laws and regulations. Seller has no knowledge of any
condemnation, environmental, zoning or other land-use regulation proceeding,
either instituted or planned to be instituted, which would affect the Owned
Properties nor has Seller any knowledge of any assessments affecting the
Owned Properties.
8
<PAGE>
ARTICLE V
PERMITS AND APPROVALS
5.1 PERMITS AND APPROVALS. Seller and Buyer each agree to cooperate
and use their best efforts to obtain, and will promptly prepare all
registrations, filings and applications, requests and notices preliminary to,
all Approvals and Permits that may be necessary or which may be reasonably
requested by Buyer to consummate the transactions contemplated herein. Seller
and Buyer shall use reasonable efforts to obtain such consents to the assignment
of the Assumed Contracts as may be required. Notwithstanding anything herein to
the contrary, the parties hereto acknowledge and agree that at the Closing,
Seller will not assign to Buyer any Assumed Contract that by its terms requires,
prior to such assignment, the consent of any other contracting party thereto
unless such consent has been obtained prior to the Closing Date. With respect to
each such Assumed Contract not assigned on the Closing Date, after the Closing
Date Seller shall continue to deal with the other contracting party(ies) to such
Assumed Contract as the prime contracting party, and Buyer and Seller shall use
their best efforts to obtain the consent of all required parties to the
assignment of such Assumed Contract. Such Assumed Contract shall be promptly
assigned by Seller to Buyer after receipt of such consent after the Closing
Date. Notwithstanding the absence of any such consent, Buyer shall be entitled
to the benefits of such Assumed Contract accruing after the Closing Date; Buyer
agrees to perform all of the obligations of Seller to be performed under such
Assumed Contract after the Closing Date.
ARTICLE VI
EMPLOYEES
6.1 EMPLOYMENT MATTERS. Seller shall be solely responsible for and
shall promptly pay all accrued vacation, sick pay and COBRA coverage and all
severance and related obligations to employees of Seller, including any
obligations or liabilities of Seller under any of its employee benefit plans,
arising on or prior to the Closing or as a result of the transactions
contemplated by this Agreement. Buyer does not assume, and shall not be deemed
to assume, any liability or obligation of Seller relating to employment matters
involving current or former employees of Seller. Buyer contemplates making
offers of employment to all employees of the Business, except those persons
identified on SCHEDULE 6.1. The persons who accept Buyer's offer of employment
shall be referred to as "TRANSFERRED EMPLOYEES." Buyer will not be obligated to
retain the Transferred Employees for any definite period of time. The terms,
conditions, benefits and obligations of employment offered to the Transferred
Employees shall be established by Buyer, and shall not be linked to the previous
arrangements between Seller and the Transferred Employees.
9
<PAGE>
ARTICLE VII
POST CLOSING FURTHER ASSURANCES
7.1 REAL PROPERTY TRANSFER DOCUMENTATION. Seller shall, concurrently
with the Closing, grant to Buyer a thirty day rent and royalty free license
to occupy and use the real property (together with all improvements and
fixtures thereon, and all rights, privileges, licenses, tenements,
hereditaments and appurtenances relating thereto) owned by Seller at 515
Lincoln Way West, South Bend, Indiana 46601, 705 North Park Street, Kalamazoo,
Michigan 49007, and 606 West North Temple, Salt Lake City, Utah 84119
(collectively, the "Owned Properties") in the manner in which the Owned
Properties were used prior to the Closing. Within ten days after the Closing
Date, Seller, at its sole expense, shall provide Buyer with a preliminary
title report for an owner's policy of title insurance for each of the Owned
Properties. On or before the thirtieth day after the Closing Date, Buyer
shall provide notice to Seller of any of the Owned Properties which Buyer
has, for any valid reason stemming from any title, Encumbrance or
environmental issue, elected to reject (the "Rejected Property"). For any
Rejected Property, Buyer and Seller shall enter into a twelve month lease
(which lease shall commence upon the receipt by Seller from Buyer of notice
of any Rejected Property) with rent payable at a rate equal to rents of
comparable properties by Buyer during the term thereof to allow Buyer to
relocate the operations conducted at the respective location of the Rejected
Property. Upon the earlier to occur of the thirtieth day after the Closing
Date or Seller's receipt of notice from Buyer requesting conveyance of the
Owned Properties, Seller shall convey to Buyer by grant deed, or other
necessary or desirable conveyance document, fee simple title to all of the
Owned Properties which are not Rejected Properties, subject only to such
liens, encumbrances, easements and rights of others as may be of record as of
the Closing Date. The transfer of such Owned Properties shall be affected
through an escrow service, title company or as otherwise may be the custom
and practice for the transfer of similar properties in the applicable
jurisdiction. Other than as indicated above, Buyer shall pay all expenses
related to the transfer and conveyance to Buyer of such Owned Properties,
including, but not limited to, recording fees, documentary, transfer,
mortgage and intangible taxes, escrow and title insurance fees and costs and
all other similar fees and expenses. Seller shall use its best efforts to
cause the existing mortgage on the property located at 606 West North Temple,
Salt Lake City, Utah 64116 (the "Mortgage") to be assigned to Buyer. If such
mortgage is not assignable, and if such property is conveyed to Buyer, Buyer
shall satisfy such Mortgage in full at the time such property is conveyed to
Buyer. Any disputes arising under this Section 7.1 shall be resolved by
binding arbitration pursuant to Section 10.9 of this Agreement.
10
<PAGE>
7.2 FURTHER ASSURANCES. Seller will execute and deliver all such other
and additional instruments, notices, releases, undertakings, consents and other
documents, and will do all such other acts and things, as may be reasonably
requested by Buyer as necessary to assure to Buyer all the rights and interests
granted or intended to be granted under this Agreement. Seller shall take or
shall cause to be taken such other reasonable actions as Buyer may require more
effectively to transfer, convey and assign to, and vest in, Buyer, and put Buyer
in possession of, the Purchased Assets as contemplated by this Agreement. In the
event that any Purchased Asset cannot be fully and effectively transferred to
Buyer without the consent of a third party or parties, Seller shall thereafter
be obligated to use its best efforts to assure Buyer the benefits of such asset,
contract, commitment, other arrangement or other Purchased Asset.
ARTICLE VIII
TRANSACTION COVENANTS
8.1 EXPENSES AND TAXES. All costs and expenses incurred in connection
with this Agreement and the transactions contemplated hereby shall be paid by
the party incurring such expense. Any sales, use or other transfer taxes
applicable to the conveyance and transfer from Seller to Buyer of the Purchased
Assets and any other transfer or documentary taxes or any filing or recording
fees applicable to such conveyance and transfer shall be paid by Seller.
8.2 ALLOCATION OF PURCHASE PRICE. The parties agree within 60 days
after the Closing to complete duplicate IRS Form 8594 (Asset Acquisition
Statement) as required by Section 1060 of the Internal Revenue Code in
accordance with the allocation of purchase price adopted by the Buyer in its
sole discretion. The parties further agree to make no change or alteration of
the Form 8594 and to file no Supplemental Statement Form 8594 without at least
15 days' prior written notice to the other party of the nature and extent of the
changes, which notice shall include the revised or Supplemental Statement Form
8594.
8.3 BULK SALES. Buyer waives compliance with any laws and regulations
relating to bulk transfers in connection with the transactions contemplated by
this Agreement, subject to the indemnities of Seller contained in this
Agreement. Nothing in this Section 8.3 will estop or prevent Buyer or Seller
from asserting as a bar or defense in any Action or proceeding brought under any
bulk transfer law that such law does not apply to the transactions contemplated
by this Agreement.
8.4 REGULATORY INSPECTIONS. Seller shall provide to Buyer all FDA and
other regulatory agency reports, inspections, permits, and all correspondence
related thereto relating to the Centers or the Business.
11
<PAGE>
8.5 LEASES AND AMENDMENTS. Seller shall provide to Buyer copies of all
leases related to the Centers and copies of all amendments thereto.
8.6 RESPONSIBLE HEADS. Seller shall provide to Buyer satisfactory
resumes of all responsible heads of Centers.
ARTICLE IX
INDEMNIFICATION
9.1 OBLIGATIONS OF SELLER. Seller agrees to indemnify and hold Buyer
harmless from and against any and all Losses of Buyer and its directors,
officers, employees, affiliates, agents and assigns (the "BUYER INDEMNITEES"),
directly or indirectly, as a result of, or based upon or arising from, (a) any
inaccuracy in or breach or nonperformance of any of the representations,
warranties, covenants or agreements made by Seller in or pursuant to this
Agreement, (b) any other matter as to which Seller in other provisions of this
Agreement has agreed to indemnify Buyer, (c) any Excluded Liability, including
any liability or obligation of Seller or any of its affiliates not expressly
assumed by Buyer pursuant to Section 2.1 hereof, (d) any third party claims in
respect of the Centers, the Business or the Purchased Assets or regarding the
conduct of the Centers or the Business or the use of the Purchased Assets
arising prior to the Closing that are asserted prior to, on or after the
Closing, (e) any noncompliance with any laws relating to bulk transfers in
connection with the transactions contemplated by this Agreement, and/or (f) the
letter, or breach of any agreement made in the letter agreement executed October
20, 1997, by and between Daniel Idema of American Plasma Management, Inc., and
Joseph Rosen of Sera-Tec Biologicals Limited Partnership, a copy of which is
included as Exhibit F, or any Losses incurred by Buyer and/or the Buyer
Indemnitees as a result thereof, based thereon or arising therefrom.
9.2 OBLIGATIONS OF BUYER. Buyer agrees to indemnify and hold Seller
harmless from and against any Losses of Seller and its directors, officers,
employees, affiliates, agents and assigns, directly or indirectly, as a result
of, or based upon or arising from, (a) any of the Assumed Liabilities and/or (b)
any third party claims in respect of the Centers or the Business or Purchased
Assets or regarding the conduct of the Centers or the Business or the use of the
Purchased Assets based upon facts or events occurring after the Closing.
9.3 PROCEDURE.
9.3.1 NOTICE OF LOSS. The Indemnified Party with respect to any
Loss shall give prompt notice thereof to the Indemnifying Party. Notwithstanding
the foregoing, (a) no Indemnified Party shall have any obligation to give any
notice of any
12
<PAGE>
asserted liability by a third party unless such assertion is in writing, and (b)
the rights of any Indemnified Party to be indemnified in respect of any Loss
resulting from the asserted liability shall not be adversely affected by the
Indemnified Party's failure to give or delay in giving notice unless (and then
only to the extent that) the Indemnifying Party is materially prejudiced
thereby.
9.3.2 DEFENSE. If any claim, demand or liability is asserted by
any third party against any Indemnified Party, the Indemnifying Party shall upon
the written request of the Indemnified Party, defend any action or proceeding
brought against the Indemnified Party in respect of matters embraced by the
indemnity, with counsel reasonably acceptable to the Indemnified Party. If,
after a request to defend any action or proceeding, the Indemnifying Party
neglects or refuses to defend the Indemnified Party, a recovery against the
latter suffered by it in good faith is conclusive in its favor against the
Indemnifying Party. The parties shall cooperate in the defense of all third
party claims which may give rise to Indemnifiable Claims hereunder. In
connection with the defense of any claim, each party shall make available to the
party controlling such defense, any books, records or other documents within its
control that are reasonably requested in the course of, or are necessary or
appropriate for such defense.
9.4 NOT EXCLUSIVE REMEDY. This Article IX shall not be deemed to
preclude or otherwise limit in any way the exercise by Buyer or Seller of their
respective other rights or pursuit of other remedies specified in this
Agreement.
ARTICLE X
GENERAL
10.1 AMENDMENTS; WAIVERS; REMEDIES. This Agreement and any Schedule or
Exhibit may be amended only by agreement in writing of both parties. No waiver
of any provision nor consent to any exception to the terms of this Agreement
shall be effective unless in writing and signed by the party to be bound and
then only to the specific purpose, extent and instance so provided. All rights
and remedies existing under this Agreement are cumulative to, and not exclusive
of, any rights or remedies otherwise available under applicable law. No failure
on the part of either party to exercise or delay in exercising any right
hereunder shall be deemed a waiver thereof, nor shall any single or partial
exercise preclude any further or other exercise of such or any other right.
10.2 ENTIRE AGREEMENT; CONSTRUCTION. This Agreement is the entire
agreement between the parties hereto with respect to the subject matter hereof
and supersedes all prior communication, representations, agreements and
understandings between the
13
<PAGE>
parties hereto, whether oral or written, including, without limitation, the
letter of intent, dated November 14, 1997, by and between Buyer and Seller. The
representations and warranties contained in or made pursuant to this Agreement
shall survive the Closing and shall expire only upon expiration of the
applicable statute of limitations, if any. The descriptive headings of the
Articles, Sections and Subsections of this Agreement are for convenience only
and do not constitute a part of this Agreement.
10.3 GOVERNING LAW. This Agreement and the legal relations between the
parties shall be governed by and construed in accordance with the laws of the
State of California applicable to contracts made and performed in such State and
without regard to conflicts of law doctrines.
10.4 COUNTERPARTS. This Agreement and any amendment hereto or any
other agreement (or document) delivered pursuant hereto may be executed in one
or more counterparts and by different parties in separate counterparts. All of
such counterparts shall constitute one and the same agreement (or other
document) and shall become effective (unless otherwise therein provided) when
one or more counterparts have been signed by each party and delivered to the
other party. Fax signatures shall constitute original signatures for all
purposes of this Agreement.
10.5 PARTIES IN INTEREST. This Agreement will be binding upon and
inure to the benefit of each party, and nothing in this Agreement, express or
implied, is intended to confer upon any other person any rights or remedies of
any nature whatsoever under or by reason of this Agreement. Nothing in this
Agreement is intended to relieve or discharge the obligation of any third person
to either party to this Agreement.
10.6 NOTICES. Any notice or other communication hereunder must be
given in writing and either (a) delivered in person, or (b) delivered by a
reputable courier service, or (c) transmitted by facsimile, provided that any
notice so given is also mailed as provided in clause (d), or (d) mailed, postage
prepaid, as follows:
IF TO BUYER, ADDRESSED TO:
SeraCare Acquisitions, Inc.
Attn: Mr. Jerry Burdick
1925 Century Park East, Suite 1970
Los Angeles, California 90067
FAX: (310) 772-7770
14
<PAGE>
IF TO SELLER, ADDRESSED TO:
American Plasma Management, Inc.
Attn: Mr. Daniel Idema
4764 South 9th East
Salt Lake City, Utah 84117
FAX: (800) 525-3178
or to such other address or to such other person as either party shall have last
designated by such notice to the other party. Each such notice or other
communication shall be effective (A) if given by facsimile, when transmitted to
the applicable number so specified in (or pursuant to) this Section 10.7
provided that appropriate confirmation of receipt is generated by the facsimile
and a duplicate copy is mailed, postage prepaid, (B) if given by mail, three
days after such communication is deposited in the mails with first class postage
prepaid, addressed as aforesaid or (C) if given by any other means, when
actually delivered at such address.
10.7 ATTORNEYS' FEES. In the event of any Action for breach of this
Agreement or misrepresentation by either party, the prevailing party shall be
entitled to reasonable attorneys' fees, costs and expenses incurred in such
Action. Attorneys fees' incurred in enforcing any judgment in respect of
this Agreement are recoverable as a separate item. The preceding sentence is
intended to be severable from the other provisions of this Agreement and to
survive any judgment and, to the maximum extent permitted by law, shall not be
deemed merged into any such judgment.
10.8 SEVERABILITY. If any provision of this Agreement is determined to
be invalid, illegal or unenforceable by any court or governmental entity, the
remaining provisions of this Agreement to the extent permitted by law shall
remain in full force and effect provided that the economic and legal substance
of the transaction contemplated is not affected in any manner materially adverse
to either party. In the event of any such determination, the parties agree to
negotiate in good faith to modify this Agreement to fulfill as closely as
possible the original intents and purposes hereof. To the extent permitted by
law, the parties hereby to the same extent waive any provision of law that
renders any provision hereof prohibited or unenforceable in any respect.
10.9 ARBITRATION. Any controversy or claim arising out of or relating
to this Agreement or the breach hereof shall be settled by arbitration in Los
Angeles, California. The arbitration shall be administered by Judicial
Arbitration and Mediation Services, the Company ("JAMS") in its Los Angeles
office. The arbitrator shall be a retired superior court judge of the State of
California affiliated with JAMS. Each of the
15
<PAGE>
parties reserves the right to file with a court of competent jurisdiction an
application for temporary or preliminary injunctive relief, writ of attachment,
writ of possession, temporary protective order and/or appointment of a receiver
on the grounds that the arbitration award to which the applicant may be entitled
may be rendered ineffectual in the absence of such relief. Judgment upon the
award rendered by the arbitrator may be entered in any court having jurisdiction
thereof. The parties may obtain discovery in aid of the arbitration to the
fullest extent permitted under law. All discovery disputes shall be resolved by
the arbitrator. Any arbitration hereunder may be consolidated by JAMS with the
arbitration of any other dispute arising out of or relating to the same subject
matter when the arbitrator determines that there is a common issue of law or
fact creating the possibility of conflicting rulings by more than one
arbitrator. Any disputes over which arbitrator shall hear any consolidated
matter shall be resolved by JAMS. The arbitrator shall not have any power to
alter, amend, modify or change any of the terms of this Agreement nor to grant
any remedy which is either prohibited by the terms of this Agreement or not
available in a court of law. All questions in respect of procedure to be
followed in conducting the arbitration as well as the enforceability of this
agreement to arbitrate which may be resolved by state law shall be resolved
according to the law of the State of California. The costs of the arbitration,
including any JAMS administration fee, and arbitrator's fee, and costs of the
use of facilities during the hearings, shall be borne equally by the parties.
Costs and attorneys' fees shall be awarded to the prevailing party as
contemplated by Section 10.7.
16
<PAGE>
IN WITNESS WHEREOF, each of the parties hereto has caused this
Agreement to be executed by a duly authorized officer as of the day and year
first above written.
"BUYER"
SeraCare Acquisitions, Inc.
By: /s/ Jerry L. Burdick
---------------------------------
Name: Jerry L. Burdick
------------------------------
Title: Executive Vice President
------------------------------
"SELLER"
American Plasma Management, Inc.,
By: /s/ Daniel L. Idema
---------------------------------
Name: Daniel L. Idema
------------------------------
Title: President
------------------------------
American Plasma Reno, Inc.
By: /s/ Daniel L. Idema
---------------------------------
Name: Daniel L. Idema
------------------------------
Title: President
------------------------------
American Plasma Systems, Inc.
By: /s/ Daniel L. Idema
---------------------------------
Name: Daniel L. Idema
------------------------------
Title: President
------------------------------
S-1
<PAGE>
APPENDIX I
The defined terms used in that certain Asset Purchase Agreement, dated
November 29, 1997 (the "AGREEMENT") , by and between SeraCare Acquisitions,
Inc., ("BUYER") on the one hand, and American Plasma Management, Inc., American
Plasma Reno, Inc., and American Plasma Systems, Inc., (collectively, the
"SELLER") on the other hand, of which this Appendix forms a part, have the
meanings assigned to them in this Appendix I and include the plural as well as
the singular. All accounting terms used in the Agreement not otherwise defined
herein have the meanings assigned under generally accepted accounting
principles. All references in the Agreement to designated "Articles,"
"Sections" and other subdivisions are to the designated Articles, Sections and
other subdivisions of the body of the Agreement. Pronouns of either gender or
neuter shall include, as appropriate, the other pronoun forms. The words
"herein," "hereof" and "hereunder" and other words of similar import refer to
the Agreement as a whole and not to any particular Article, Section or other
subdivision.
As used in the Agreement and the Exhibits and Schedules, the following
definitions shall apply:
"ACTION" means any action, complaint, charge, investigation, petition,
suit or other proceeding, whether civil or criminal, in law or in equity, or
before any arbitrator or federal, state or local administrative body.
"APPROVAL" means any approval, authorization or consent, or any waiver
of any of the foregoing, required to be obtained from, or any notice, statement
or other communication required to be filed with or delivered to, any person or
entity, the receipt of which is necessary to the continued operation of the
Business as it has been operated prior to the Closing Date.
"ASSUMED CONTRACT" means the Leases and each contract specifically
identified on SCHEDULE 4.5.
"ASSUMED LIABILITIES" means those liabilities and obligations of
Seller relating to the Business that are specifically identified in Section 2.1.
"CLOSING" shall mean the consummation of the purchase and sale
transaction described in the Agreement which shall occur on the Closing Date.
"CLOSING DATE" has the meaning specified in Section 3.1.
"ENCUMBRANCE" means any claim, charge, covenant, easement,
encumbrance, security interest, lien, option, pledge, rights of others, or
restriction (whether on sale, transfer,
Appendix I-1
<PAGE>
disposition or otherwise), whether imposed by agreement, understanding, law,
equity or otherwise.
"ERISA" means the U.S. Employee Retirement Income Security Act of
1974, as amended, and the related regulations and published interpretations.
"EXCLUDED LIABILITIES" has the meaning specified in Section 2.2.
"FINANCIAL STATEMENTS" has the meaning specified in Section 4.3.1.
"GAAP" means generally accepted accounting principles in the United
States as in effect from time to time.
"INDEMNIFIABLE CLAIM" means any Loss for or against which any party is
entitled to indemnification under the Agreement; "INDEMNIFIED PARTY" means the
party entitled to indemnity under the Agreement; and "INDEMNIFYING PARTY" means
the party obligated to provide indemnification under the Agreement.
"INTELLECTUAL PROPERTY" means all Marks, together with the goodwill
and the business appurtenant thereto and any rights, claims or choses in action
relating to or deriving from any of the foregoing used as of the date of the
Agreement or prior to the date of the Agreement in the Business.
"INVENTORY" means merchandise and other assets existing on the Closing
Date that are held or intended for sale.
"LEASES" means those certain lease agreements listed on SCHEDULE 4.7
covering a real property leasehold interest used by Seller in connection with
its operation of the Business at 785 East 2nd Street, Reno, Nevada and 1021
Broadway Avenue, Boise, Idaho, together with all amendments, modifications,
alterations and other changes thereto.
"LOSS" means any action, cost, damage, disbursement, expense,
liability, loss, deficiency, diminution in value, obligation, penalty, fine,
assessment or settlement of any kind or nature, whether foreseeable or
unforeseeable, including but not limited to, interest or other carrying costs,
penalties, reasonable legal, accounting and other professional fees and expenses
incurred in the investigation, collection, prosecution and defense of claims,
inquiries, hearings or other legal or administrative proceedings, and amounts
paid in settlement, that may be imposed on or otherwise incurred or suffered by
the specified person.
"MARK" means any brand name, copyright, patent service mark,
trademark, tradename and all registration or applications for registration of
any of the foregoing.
Appendix I-2
<PAGE>
"ORDER" means any decree, injunction, judgment, order, ruling,
assessment or writ.
"OWNED PROPERTIES" has the meaning specified in Section 7.1
"PERMIT" means any license, permit, franchise, certificate of
authority, or order, or any waiver of the foregoing, required to be issued by
any governmental entity in connection with, and necessary to the operation of,
the Business.
"PREPAID EXPENSES" means all advance payments, security deposits, rent
deposits and utility deposits paid by Seller to third parties in connection with
the Purchased Assets that remain outstanding as credit balances in favor of
Seller on the Closing Date.
"PURCHASE PRICE" has the meaning specified in Section 2.3.
"PURCHASED ASSETS" has the meaning specified in Section 2.1
"REAL PROPERTY" means all land, including the real property at 515
Lincoln Way West, South Bend, Indiana, 705 North Park Street, Kalamazoo,
Michigan and 606 West North Temple, Salt Lake City, Utah, including all
buildings, fixtures and improvements attached thereto, and all rights
appurtenant thereto, identified on SCHEDULE 4.7, used by Seller in connection
with its operation of the Centers and/or the Business, and including the
leasehold interests under the Leases.
"TAX" means any foreign, federal, state, county or local income, use,
excise, franchise, real and personal property, transfer, gross receipt, capital
stock, production, business and occupation, disability, employment, payroll,
severance or withholding tax or charge imposed by any governmental entity, any
interest and penalties (civil or criminal) related thereto or to the nonpayment
thereof, and any Loss in connection with the determination, settlement or
litigation of any Tax liability.
"TRANSFERRED EMPLOYEES" has the meaning specified in Section 6.1.
Appendix I-3
<PAGE>
EXHIBIT A
PURCHASED ASSETS
The Purchased Assets shall include but not be limited to the
following:
(a) the Real Property, including the real property at 515 Lincoln Way
West, South Bend, Indiana, 705 North Park Street, Kalamazoo, Michigan and 606
West North Temple, Salt Lake City, Utah (collectively, the "OWNED PROPERTIES"),
and including the Leasehold interests in real property covered by the Leases,
and all leasehold improvements located on such real property; provided, however,
notwithstanding anything to the contrary contained in that certain Asset
Purchase Agreement, dated as of November 29, 1997 (the "ASSET PURCHASE
AGREEMENT"), by and between SeraCare Acquisitions, Inc., on the one hand, and
American Plasma Management, Inc., American Plasma Reno, Inc. and American Plasma
Systems, Inc., on the other hand, or in the related Bill of Sale, title to the
Owned Properties shall only transfer to Buyer in accordance with the provisions
of Section 7.1 of the Asset Purchase Agreement;
(b) All of the assets relating to the Centers, including all
machinery, vehicles, tools, apparatus, equipment, computer hardware and
equipment, furniture, fixtures, supplies and other equipment of every type owned
or leased by Seller and used in connection with the Business;
(c) All Inventory, including source plasma inventories, reactive
HBsAg plasma inventories, plasma softgoods inventories, miscellaneous medical
and office supplies;
(d) All of Seller's rights and interests arising under or in
connection with the Assumed Contracts;
(e) All Intellectual Property, including standard operating
procedures and product labeling;
(f) All transferable Permits, including FDA establishment licenses,
FDA issued specialty product licenses, QPP and CLIA and any other regulatory
approvals pertaining to the Centers;
(g) The FDA plasma license presently related to a plasma facility in
Lansing, Michigan which has ceased operations;
(h) All books and records and all files, documents, papers and
agreements (including those contained in computerized media) pertaining to the
Purchased Assets or the Assumed Liabilities (excluding the minute and stock
record books of Seller);
A-1
<PAGE>
(i) Customer and vendor records, donor record files, donor scheduling
information, market information, donation cost information, mailing lists, sales
materials, advertising materials and related documentation; and
(j) the goodwill incident to the Business.
A-2
<PAGE>
EXHIBIT B
PROMISSORY NOTE
November 29, 1997
Amount: $600,000
FOR VALUE RECEIVED, the undersigned SeraCare, Inc. ("Maker"), promises
to pay to American Plasma Management, Inc., American Plasma Reno, Inc., and
American Plasma Systems, Inc. (collectively, the "Lenders"), the principal sum
of $600,000, in the aggregate, together with interest on the unpaid principal
balance on October 31, 1998 (the "MATURITY DATE"). American Plasma Reno, Inc.
and American Plasma Systems agree payment shall be tendered to American Plasma
Management, Inc.
1. INTEREST RATE. The unpaid principal under this Promissory Note
shall bear interest at a rate of eight percent (8%) per annum simple interest.
Interest is payable on the Maturity Date or earlier upon any prepayment of this
Promissory Note.
2. PAYMENTS. The unpaid principal under this Promissory Note plus
all accrued but unpaid interest thereon shall be payable not later than October
31, 1998. Maker may prepay the amount due at any time.
3. AMENDMENTS IN WRITING. This Promissory Note may be changed,
modified or amended only in writing.
4. CHOICE OF LAW. This Promissory Note and all transactions
hereunder and/or evidenced hereby shall be governed by, construed under, and
enforced in accordance with the laws of the State of California without regard
to the conflicts of laws principles thereof.
5. ENTIRE AGREEMENT. This Promissory Note contains the entire
understanding among the parties hereto with respect to the subject matter hereof
and supersedes all prior written and oral agreements, understandings,
commitments and practices between the parties; provided, however, amounts owed
under this Promissory Note are subject to set off against amounts owed to
SeraCare Acquisitions, Inc. by the Lenders for any breach of any representation,
warrant or covenant in the Asset Purchase Agreement, dated of even date
herewith, between SeraCare Acquisitions, Inc. and the Lenders and/or against
amounts owed to SeraCare Acquisitions, Inc. as a result of the indemnification
obligations of the Lenders under such agreement.
B-1
<PAGE>
6. TRANSFERABILITY. The right to principal and interest under this
Promissory Note may be transferred only through a book entry system maintained
by Maker. Any other means of transfer, including, without limitation, transfers
by endorsement, shall be null and void. Ownership of the obligation must be
reflected in a book entry. A book entry is a record of ownership that identifies
the owner of an interest in this Promissory Note.
Made and Executed at
Los Angeles, California SeraCare, Inc.
By:
------------------------------
Name:
---------------------------
Title:
---------------------------
Acknowledged and Agreed:
American Plasma Management, Inc.
By:
------------------------------
Name:
---------------------------
Title:
---------------------------
American Plasma Reno, Inc.
By:
------------------------------
Name:
---------------------------
Title:
---------------------------
American Plasma Systems, Inc.
By:
------------------------------
Name:
---------------------------
Title:
---------------------------
B-2
<PAGE>
EXHIBIT C
BILL OF SALE
For good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, and pursuant to the Asset Purchase Agreement,
dated as of November 29, 1997 (the "Agreement"), between SeraCare Acquisitions,
Inc. ("Buyer"), and American Plasma Management, Inc., American Plasma Reno,
Inc. and American Plasma Systems, Inc., (collectively, the "Seller"), and
intending to be legally bound hereby, Seller hereby unconditionally and
irrevocably sells, conveys, grants, assigns and transfers to Buyer and its
successors and assigns all of Seller's legal, beneficial, and other right,
title, and interest in and to the business and assets, properties, rights,
interests, privileges, claims and contracts of every kind and nature, tangible
and intangible, described as "Purchased Assets" in Section 2.1 of the Agreement,
including, without limitation, those assets set forth on Exhibit A attached
hereto.
This Bill of Sale shall be binding upon and inure to the benefit of
Buyer and Seller and their respective successors and assigns.
IN WITNESS WHEREOF, Seller has caused this Bill of Sale to be executed
as of this 29th day of November, 1997.
AMERICAN PLASMA MANAGEMENT, INC.
By:
------------------------------
Name:
---------------------------
Title:
---------------------------
AMERICAN PLASMA RENO, INC.
By:
------------------------------
Name:
---------------------------
Title:
---------------------------
AMERICAN PLASMA SYSTEMS, INC.
By:
------------------------------
Name:
---------------------------
Title:
---------------------------
C-1
<PAGE>
EXHIBIT A
PURCHASED ASSETS
The Purchased Assets shall include but not be limited to the
following:
(a) the Real Property, including the real property at 515 Lincoln Way
West, South Bend, Indiana, 705 North Park Street, Kalamazoo, Michigan and 606
West North Temple, Salt Lake City, Utah (collectively, the "OWNED PROPERTIES"),
and including the Leasehold interests in real property covered by the Leases,
and all leasehold improvements located on such real property; provided, however,
notwithstanding anything to the contrary contained in that certain Asset
Purchase Agreement, dated as of November 29, 1997 (the "ASSET PURCHASE
AGREEMENT"), by and between SeraCare Acquisitions, Inc., on the one hand, and
American Plasma Management, Inc., American Plasma Reno, Inc. and American Plasma
Systems, Inc., on the other hand, or in the related Bill of Sale, title to the
Owned Properties shall only transfer to Buyer in accordance with the provisions
of Section 7.1 of the Asset Purchase Agreement;
(b) All of the assets relating to the Centers, including all
machinery, vehicles, tools, apparatus, equipment, computer hardware and
equipment, furniture, fixtures, supplies and other equipment of every type owned
or leased by Seller and used in connection with the Business;
(c) All Inventory, including source plasma inventories, reactive
HBsAg plasma inventories, plasma softgoods inventories, miscellaneous medical
and office supplies;
(d) All of Seller's rights and interests arising under or in
connection with the Assumed Contracts;
(e) All Intellectual Property, including standard operating
procedures and product labeling;
(f) All transferable Permits, including FDA establishment licenses,
FDA issued specialty product licenses, QPP and CLIA and any other regulatory
approvals pertaining to the Centers;
(g) The FDA plasma license presently related to a plasma facility in
Lansing, Michigan which has ceased operations;
(h) All books and records and all files, documents, papers and
agreements (including those contained in computerized media) pertaining to the
Purchased Assets or the Assumed Liabilities (excluding the minute and stock
record books of Seller);
C-2
<PAGE>
(i) Customer and vendor records, donor record files, donor scheduling
information, market information, donation cost information, mailing lists, sales
materials, advertising materials and related documentation; and
(j) the goodwill incident to the Business.
C-3
<PAGE>
EXHIBIT D
ASSIGNMENT AND ASSUMPTION AGREEMENT
For good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, and pursuant to the Asset Purchase Agreement,
dated as of November 29, 1997 (the "Agreement") between SeraCare Acquisitions,
Inc., ("Buyer"), and American Plasma Management, Inc., American Plasma Reno,
Inc. and American Plasma Systems, Inc., (collectively, the "Seller") and
intending to be legally bound hereby, Seller hereby assigns and Buyer hereby
assumes and agrees to perform the obligations of Seller listed on Exhibit A,
attached hereto.
The Assumed Liabilities do not include, and Buyer does not hereby
assume, agree to pay or otherwise perform any other liabilities or obligations
of Seller.
This Assignment and Assumption Agreement shall be binding upon and
inure to the benefit of Buyer and Seller and their respective successors and
assigns.
IN WITNESS WHEREOF, the paries hereto have caused this Assignment and
Assumption Agreement to be executed as of this 29th day of November, 1997.
SeraCare Acquisitions, Inc.
By:
----------------------------------
Name:
--------------------------------
Title:
-------------------------------
American Plasma Management, Inc.
By:
----------------------------------
Name:
--------------------------------
Title:
-------------------------------
American Plasma Reno, Inc.
By:
----------------------------------
Name:
--------------------------------
Title:
-------------------------------
D-1
<PAGE>
American Plasma Systems, Inc.
By:
----------------------------------
Name:
--------------------------------
Title:
-------------------------------
D-2
<PAGE>
EXHIBIT A
LIST OF ASSIGNMENTS AND ASSUMPTIONS
1. Obligations under the Leases (as defined in the Agreement).
D-3
<PAGE>
EXHIBIT E
ASSIGNMENT AND ASSUMPTION OF LEASES
THIS ASSIGNMENT AND ASSUMPTION OF LEASES (this "ASSIGNMENT") is made
as of the 29th day of November, 1997 by American Plasma Management, Inc.,
American Plasma Reno, Inc. and American Plasma Systems, Inc., to SeraCare
Acquisitions, Inc. In connection with such conveyance, Assignor desires to
assign to Assignee, and Assignee desires to accept such assignment from
Assignor, all the right, title and interest of Assignor in and to any and all
leases in connection with the subject property (the "Leases"), all as more
completely described on SCHEDULE 1 attached hereto and by this reference
incorporated herein.
AGREEMENT
For good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, and pursuant to the Asset Purchase Agreement,
dated November 29, 1997, by and between SeraCare Acquisitions, Inc. and American
Plasma Management, Inc., American Plasma Reno, Inc. and American Plasma Systems,
Inc., Assignor and Assignee hereby agree as follows:
1. ASSIGNMENT. Effective as of the date hereof (the "EFFECTIVE DATE"),
Assignor hereby grants, assigns, transfers and conveys to Assignee, and
Assignee hereby accepts from Assignor such grant, assignment, transfer and
conveyance, all right, title and interest of Assignor in and to the Leases.
Assignee hereby assumes and agrees to perform and to be bound by all of the
terms, covenants, conditions and obligations of Assignor under the Leases
which arise on or after the Effective Date (the "POST EFFECTIVE DATE
OBLIGATIONS").
2. ASSIGNEE INDEMNITY. Assignee hereby agrees to protect, defend, indemnify
and save and hold harmless Assignor from and against the Post Effective
Date Obligations and any and all liability, loss, costs, damage or expense
(including attorneys' fees, charges and expenses) which Assignor may incur
under the Leases, and from any and all claims and demands whatsoever which
may be asserted against Assignor by reason of any alleged obligation or
undertaking on Assignor's part to perform or discharge any of the terms,
covenants or agreements contained in any of the Leases, which claims or
demands arise from events occurring on or after the Effective Date.
3. ASSIGNOR INDEMNITY. Assignor hereby agrees to protect, defend, indemnify
and save and hold harmless Assignee from and against any and all liability,
loss, cost, damage or
E-1
<PAGE>
expense (including attorneys' fees, charges and expenses) which Assignee
may incur under the Leases, by reason of any failure of Assignor to perform
or discharge any of the terms, covenants or agreements contained in the
Leases which arose prior to the Effective Date.
4. FURTHER ASSURANCES. Each party agrees to execute such other and further
instruments as may be necessary or proper in order to consummate the
transactions contemplated by this Assignment.
5. SUCCESSORS AND ASSIGNS. This Assignment shall be binding upon and inure to
the benefit of the respective successors and assigns of Assignor and
Assignee.
6. ATTORNEYS' FEES AND COSTS. If either party to this Assignment brings any
action or suit against the other party to this Assignment by reason of any
breach of any covenant, condition, agreement or provision on the part of
the other party set forth in this Assignment, the prevailing party shall be
entitled to recover from the other party all costs and expenses of the
action or suit, including reasonable attorneys' fees, in addition to any
other relief to which it may be entitled.
7. GOVERNING LAW. This Assignment shall be governed by and construed in
accordance with the laws of the State of California without regard to the
conflicts of laws principles thereof.
IN WITNESS WHEREOF, Assignor and Assignee have executed and delivered
this Assignment as of the day and year first above written.
ASSIGNOR
AMERICAN PLASMA MANAGEMENT, INC.
By:
----------------------------------
Name:
--------------------------------
Title:
-------------------------------
AMERICAN PLASMA RENO, INC.
By:
----------------------------------
Name:
--------------------------------
Title:
-------------------------------
E-2
<PAGE>
AMERICAN PLASMA SYSTEMS, INC.
By:
----------------------------------
Name:
--------------------------------
Title:
-------------------------------
ASSIGNEE
SERACARE ACQUISITIONS, INC.
By:
----------------------------------
Name:
--------------------------------
Title:
-------------------------------
E-3
<PAGE>
SCHEDULE 1
DESCRIPTION OF LEASES
See attached Leases.
E-4
<PAGE>
JAMESON 1991 REVOCABLE TRUST 4614 FAIRVIEW AV., BOISE, IDAHO
PH. 375-4992
November 25, 1996
AMERICAN PLASMA SYSTEMS
4764 SOUTH 900 EAST
SALT LAKE CITY, UTAH 84117
Dear Mr. Daniel Idema:
Concerning our lease with you at 1021 Broadway, Av., Boise, Idaho the annual
rent should be adjusted as follows:
Using the cost of living index (U) from October 1995 to October 1996, the
increase is 4.6 or 3%.
The monthly rent should be $1,234.09. However, in order to pick up the
increase for September, October, November and December of 1996 the month of
January 1997 (only) should be $1,377.85.
Please do check my arithmetic and notify me should you find me to be in error.
JAMESON 1991 REVOCABLE TRUST
/s/ Earl Jameson Tr.
-----------------------------------
Earl Jameson, Trustee
<PAGE>
June 1, 1993
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Earl Jameson
4614 Fairview Avenue
Boise, ID 83706
RE: Lease dated September 10, 1983
Premises located at 1021 Broadway Avenue, Boise, Idaho
Dear Mr. Jameson:
Pursuant to page 1, paragraph entitled "TERM OF LEASE" of the above captioned
lease agreement, American Plasma Systems, Inc. hereby exercises its option to
renew said lease for an additional term of five (5) years. Accordingly, this
action shall extend the lease term on the above captioned premises through
midnight September 9, 1998, under identical terms and conditions.
Your directing confirmation of the foregoing to this office would be greatly
appreciated.
Very truly yours,
James B. Riter
Treasurer
cc: Daniel L. Idema, President APSI
<PAGE>
LEASE OF BUSINESS PREMISES
THIS LEASE, made and entered into this 10th day of September, 1983, by
and between EARL JAMESON and VADA F. JAMESON, husband and wife, of Boise, Idaho,
hereinafter referred to as "Lessors," and AMERICAN PLASMA SYSTEMS, INC., 4764
South 900 East, Salt Lake City, Utah, 84117, a Utah Corporation, hereinafter
referred to as "Lessees," WITNESSETH:
PREMISES:
For and in consideration of the covenants and conditions hereinafter
contained and the rental payments as hereinafter specified Lessors do hereby
lease unto the Lessees the following described Real property and building
thereon located 1021 Broadway Avenue, Boise, Ada County, Idaho, 83706 to-wit:
Lots 10 and 11, of Block 24 of South Boise First
Subdivision in Ada County, State of Idaho.
TERM OF LEASE:
The term of this lease shall be for ten (10) years commencing
September 10, 1983, and ending midnight September 9, 1993. PROVIDED, HOWEVER,
Lessees shall have the option to renew this lease on the same terms and
conditions as set forth herein. If Lessers elect to renew for an additional
five (5) year period, written notice of such intention shall be given to Lessors
not later than July 30, 1993.
RENTAL:
Lessees agree to pay as rental for the use and occupancy of said
premises the sum of Eight Hundred ($800.00) Dollars per month on or before
the 10th of each month, for that month; that is to say the first monthly
payment of rent shall be made by September , 1983, and on or before the 10th
day of each and every month thereafter during the term of this lease or any
renewal thereof. It is understood and agreed that the base monthly rental of
Eight Hundred ($800.00) Dollars per month shall be adjusted toward or
downward to reflect any difference in the cost of living index from that
determined by the U.S. Government, Department of Labor, and shown on the "All
Commodity Index" for the previous November, or if no figure is shown for said
month, then on the basis of the index figure for the period nearest in time
to November 1, each year. The determination of increase or decrease cost of
living index made at the end of each 12-month period that is to say, on
November 1 of each year, shall be reflected in and shall determine the rental
for the next succeeding 12 months.
<PAGE>
INSURANCE:
Lessees shall carry fire insurance in an amount at least equal to
the reasonable value of all buildings or structures on the premises now or
which may hereafter be placed upon said premises during the term of this
lease or renewal thereof. Lessees shall also carry public liability insurance
providing coverage for premises and business operations, personal liability
and property damage in an amount not less than $500,000. In addition thereto,
Lessees do hereby agree to save and hold harmless the Lessors from any
claims, demands, lawsuits or legal proceedings and for all costs and
expenditures of whatsoever kind and nature arising out of or in connection
with the Lessees' use, occupancy and/or conduct of business on the above
described premises.
SUBLETTING:
Lessees shall have the right to sublet or assign all or a part of the
leased premises or buildings or improvements thereon, but notwithstanding such
assigning or subletting, the Lessees shall remain liable to Lessors for the full
performance of all the terms, covenants and conditions of this lease.
REMODELING AND UPKEEP:
It is understood and agreed that Lessees shall have the right to
remodel or change the buildings on said property or to add new structures
thereon, but all additions, changes or remodeled structures shall be and remain
the property of Lessors.
TAXES, ASSESSMENTS AND UTILITIES:
Lessees shall pay all taxes, lawful assessments and all utility
charges including water, gas, heat, electricity and power furnished to Lessees
on the demised premises and including all janitorial services, license fees and
other governmental charges; it being the intention herein that above specified
rent money shall be on a net-net basis to Lessors.
LAW, ORDINANCES AND REGULATIONS:
Lessees agree that they will not use or permit the premises to be
used for any illegal purpose whatsoever; that they will not offer for sale
any liquor or intoxicating beverages or drugs of any kind during the term of
this lease, and that they will at Lessees' own expense comply with all
municipal, state and government laws and regulations applicable to the
business operations or other use or occupancy of said premises by Lessees.
-2-
<PAGE>
FIRE DAMAGE:
If, during the term of this lease or any renewal thereof, damage
[ILLEGIBLE] fire or other casualty covered by insurance occurs and such
damage is to the extent that the premises are not usable for the purposes of
the Lessees, then the proceeds of any applicable fire or other casualty
insurance shall be used to repair [ILLEGIBLE] reconstruct said buildings, and
any additional sum necessary for construction purposes over and above said
insurance proceeds shall be paid and furnished by Lessees.
DEFAULT:
In the event of failure of Lessees to pay the rent herein specified
or in case of failure to perform any of the other covenants or agreements
herein contained, Lessors, at their election shall have the right to
terminate this lease by giving Lessees thirty (30) days written notice
specifying the nature of the [ILLEGIBLE] default, and if said default is not
corrected or cured by Lessees within thirty (30) days after the date of said
written notice, Lessees agree that they will immediately vacate said premises
and this lease shall thereupon be at an end subject only to the right of
Lessees to remove their personal property from said premises within the
following ten (10) day period and subject [ILLEGIBLE] to the right of the
Lessors to collect any unpaid rent [ILLEGIBLE] damages accrued prior to the
date of vacation of the premises by the Lessees. In the event it becomes
necessary for Lessors to take legal action to enforce the provisions of this
lease [ILLEGIBLE] regain possession of the premises either upon default of
the Lessees or upon expiration of the term of the lease, Lessees agree to pay
attorneys fees to Lessors in an amount to be fixed by the court.
BROKER'S FEES: Lessees shall hold Lessors harmless for or on
[ILLEGIBLE] of real estate broker's commissions in connection with [ILLEGIBLE]
lease agreement.
MISCELLANEOUS: Lessees reserve to themselves and to lessees'
customers the right to park on the West 75 feet of the south [ILLEGIBLE]
of the above described premises. The alley exit of the south side of the
lot shall not be obstructed by parked vehicles.
-3-
<PAGE>
IN WITNESS WHEREOF, the parties have set their hands this day and
year first above written.
/s/ Earl Jameson 7/22-83
-------------------------- --------
Earl Jameson Date
/s/ Vada F. Jameson 7/22-83
-------------------------- --------
Vada F. Jameson Date
Lessors
[ILLEGIBLE] AMERICAN PLASMA SYSTEMS, INC.
[ILLEGIBLE] by it's PRESIDENT
[ILLEGIBLE]
[ILLEGIBLE]
[ILLEGIBLE] /s/ Daniel L. Idema 7/19/83
-------------------------- --------
[ILLEGIBLE] Daniel L. Idema Date
STATE ( UTAH )ss
County( Salt Lake )
On the 19th day of July, 1983, personally appeared before me the
signer of the foregoing instrument, who duly acknowledged to me that
executed the same.
/s/ Shirley N. Riter
-----------------------------
Notary Public, residing at
Salt Lake City, Utah
-----------------------------
My commission expires
10-[ILLEGIBLE] 85
---------------------
-4-
<PAGE>
[LETTERHEAD]
June 7, 1990
American Plasma Management Inc.
4764 South 9th East
Salt Lake City, Utah 84117
ATTENTION: Mr. James B. Riter
Treasurer
Re: 769/785 East 2nd Street, Reno, Nevada
Dear Mr. Riter:
Enclosed herein please find the original and two copies of the Lease
dated the 1st day of January, 1990, by and between Dolores Mugnaini and Angelina
Capurro, as Landlord, and American Plasma Management, Inc., as Tenant. We had
to make changes regarding some of the language that was inaccurate. Please read
it, execute it and get it back to me.
If you have any questions, please do not hesitate to contact the
undersigned.
Very truly yours,
/s/ Leo P. Bergin
---------------------
Leo P. Bergin
LPB:jab
Enclosures
Riter [ILLEGIBLE]
cc: Mrs. Angelina Capurro
Mrs. Dolores Mugnaini
<PAGE>
LEASE
THIS LEASE is made and entered into this 1st day of January,
1990, by and between DOLORES MUGNAINI and ANGELINA CAPURRO, hereinafter
referred to as "Landlord", whose address is 5005 Longley Lane, Reno, Nevada
89511, and AMERICAN PLASMA MANAGEMENT INC., a Utah corporation, hereinafter
referred to as "Tenant", whose address is 4764 South 9th East, Salt Lake
City, Utah 84117, who agree as follows:
1. Landlord is the owner of the premises commonly known as 769
and 785 East 2nd Street, Reno, Washoe County, Nevada.
2. Tenant is willing to lease the premises from Landlord
pursuant to the provisions stated in this Lease.
3. Tenant has examined the premises and is fully informed of
their condition.
PREMISES:
Landlord leases to Tenant and Tenant leases from Landlord the
real property located in Reno, Washoe County, Nevada, commonly known as 769
and 785 East 2nd Street, together with the buildings and other improvements
located on the real property ("premises").
TERM:
The term of this Lease shall commence on January 1, 1990, and
continue until December 31, 1996.
-1-
<PAGE>
RENT:
Beginning January 1, 1990 through December 31, 1996, Tenant shall
pay to the Landlord the sum of Two Thousand Five Hundred Dollars
($2,500.00) per month for the use of the premises.
TAXES AND ASSESSMENTS ON PERSONAL PROPERTY OF TENANT:
1. Tenant shall pay before delinquency all taxes, assessments,
license fees, and other charges ("taxes") that are levied and assessed
against Tenant's other personal property installed or located in or on the
premises, and that become payable during the term. On demand by Landlord,
Tenant shall furnish Landlord with satisfactory evidence of these payments.
If any taxes on Tenant's personal property are levied
against Landlord or Landlord's property, or if the assessed value of the
premises is increased by the inclusion of a value placed on Tenant's
personal property, and if Landlord pays the taxes on any of these items or
the taxes based on the increased assessment of these items, Tenant, on
demand, shall immediately reimburse Landlord for the sum of the taxes
levied against Landlord, or the proportion of the taxes resulting from the
increase in Landlord's assessment. Landlord shall have the right to pay
these taxes regardless of the levy.
TAXES:
Tenant agrees to pay, in addition to the rental above provided,
all taxes and assessments against the premises.
-2-
<PAGE>
TRIPLE NET LEASE:
This Lease is to be considered a triple net lease with the Tenant
paying all costs of the property, including but not limited to, those
enumerated in this Lease.
NEW ASSESSMENTS:
If any general or special assessment is levied and assessed
against the premises, Tenant shall have the right to prepay any
assessments. If Tenant does not so elect, then Landlord can elect to either
pay the assessment in full or allow the assessment to go to bond. If
Landlord pays the assessment in full, Tenant shall pay to Landlord each
time a payment of real property taxes is made, a sum equal to that which
would have been payable (as both principal and interest) had Landlord
allowed the assessment to go to bond.
MAINTENANCE:
Tenant at its costs shall maintain the premises in good
condition. Landlord shall not have any responsibility to maintain the
premises. Tenant agrees to maintain the exterior of the premises,
including the roof and parking lot, and return the premises to Landlord in
the same condition as it was on December 31, 1989.
MECHANICS' LIENS:
Tenant shall pay all costs for construction done by it or cause
to be done by it on the premises as permitted by this Lease. Tenant shall
keep the building, other improvements, and
-3-
<PAGE>
land of which the premises are a part, free and clear of all mechanics'
liens resulting from construction done by or for Tenant.
Tenant shall have the right to contest the correctness or the
validity of any such lien if, immediately on demand by Landlord, Tenant
procures and records a lien release bond issued by a corporation authorized
to issue surety bonds in Nevada in an amount equal to one and one-half
times the amount of the claim of lien. The bond shall meet the
requirements of N.R.S. 108 and shall provide for the payment of a sum that
the claimant may recover on the claim (together with costs of suit, if it
recovers in the action).
UTILITIES AND SERVICES:
Tenant shall make all arrangements for and pay for all utilities
and services furnished to or used by it, including, without limitation,
gas, electricity, water, telephone service, and trash collection, and for
all connection charges.
EXCULPATION OF LANDLORD:
Landlord shall not be liable to Tenant for any damage to Tenant
or Tenant's property from any cause. Tenant waives all claims against
Landlord for damage to person or property arising for any reason.
INDEMNITY:
Tenant shall hold Landlord harmless from all damages arising out
of any damage to any person or property occurring in, on or about the
premises.
-4-
<PAGE>
PUBLIC LIABILITY AND PROPERTY DAMAGE INSURANCE:
Tenant at its costs shall maintain public liability and property damage
insurance, with liability limits of not less than $500,000.00 per person and
$1,000,000.00 per occurrence, and property damage limits of not less than
$500,000.00 per occurrence, with an aggregate coverage of $1,000,000.00,
insuring against all liability of Tenant and its authorized representatives
arising out of and in connection with Tenant's use or occupancy of the
premises.
All public liability insurance and property damage insurance shall insure
performance by Tenant of the indemnity provisions of this Lease. Both parties
shall be named as co-insureds, and the policy shall contain cross-liability
endorsements.
INSURANCE:
Tenant shall be responsible for maintaining all risk insurance coverage on
the existing premises and structures with a minimum replacement value of
$400,000.00 In addition thereto, Tenant shall insure any improvements that it
places on the premises.
WAIVER OF SUBROGATION
The parties release each other, and their respective authorized
representatives, from any claims for damage to any person or to the premises and
to the fixtures, personal property, tenant's improvements, and alterations of
either Landlord or Tenant in or on the premises that are caused by or result
from risks
-5-
<PAGE>
insured against under any insurance policies carried by the parties and in force
at the time of any such damage.
DESTRUCTION:
If, during the term, the premises are totally or partially destroyed from
any cause, rendering the premises totally or partially inaccessible or unusable,
Landlord shall restore the premises to substantially the same condition as they
were in immediately before destruction, if the restoration can be made under the
existing laws and can be completed within 90 working days after the date of the
destruction. Such destruction shall not terminate this Lease.
If the restoration cannot be made in the time stated in this paragraph,
then within 15 days after the parties determine that the restoration cannot be
made in the time stated in this paragraph, Tenant can terminate this Lease
immediately by giving notice to Landlord. If Tenant fails to terminate this
Lease and if restoration is permitted under the existing laws, Landlord, at
their election, can either terminate this Lease or restore the premises within a
reasonable time and this Lease shall continue in full force and effect. If the
existing laws do not permit the restoration, either party can terminate this
Lease immediately by giving notice to the other party.
ASSIGNMENT:
Tenant shall not voluntarily assign or encumber its interest in this Lease
or in the premises, or sublease all or any part of the premises, or allow any
other person or entity (except
-6-
<PAGE>
Tenant's authorized representatives) to occupy or use all or any part of the
premises, without first obtaining Landlord's consent, said consent not to be
unreasonably withheld. Any assignment, encumbrance or sublease without
Landlord's consent shall be voidable and, at Landlord's election, shall
constitute a default. No consent to any assignment, encumbrance or
sublease shall constitute further waiver of the provisions of this paragraph.
DEFAULT PROVISIONS:
It is agreed that in the event of a breach of any of the covenants
of this said Lease to be kept and performed by said Tenant, the Landlord
shall give Tenant a written notice of said default and if said default as set
out in said written notice remains uncorrected by said Tenant for fifteen
(15) days after receipt of said written notice, or if said default cannot be
corrected within a fifteen (15) day period, then Landlord may, at their
option, and in addition to any other rights or remedies either in [ILLEGIBLE]
or in equity they might have:
(a) Terminate this Lease and re-enter the said premises, with
or without the process of law, and remove all persons and property therefrom;
or
(b) Without terminating this Lease, recover the full rentals
and damages from the Tenant for said breach.
In the event that the rent is not paid within fifteen (15) days
from the date it is required to be paid, there will be a ten percent (10%)
late penalty for each and every payment received after said fifteen days.
-7-
<PAGE>
LANDLORD'S REMEDIES:
Landlord shall have the following remedies if Tenant commits a default.
These remedies are not exclusive; they are cumulative in addition to any
remedies now or later allowed by law.
1. Landlord can continue this Lease in full force and effect, and the
Lease will continue in effect as long as Landlord does not terminate Tenant's
right to possession, and Landlord shall have the right to collect rent when due.
During the period Tenant is in default, Landlord can enter the premises and
relet them, or any part of them, to third parties for Tenant's account. Tenant
shall be liable immediately to Landlord for all reasonable costs Landlord incurs
in reletting the premises, including, without limitation, broker's commissions,
expenses of remodeling the premises required by the reletting, and like costs.
Tenant shall pay to Landlord the rent due under this Lease on the dates the rent
is due, less the rent Landlord receives from any reletting. No act by Landlord
allowed by this paragraph shall terminate this Lease unless Landlord notifies
Tenant that Landlord elects to terminate this Lease. After Tenant's default and
for as long as Landlord does not terminate Tenant's right to possession of the
premises, if Tenant obtains Landlord's consent, Tenant shall have the right to
assign or sublet its interest in this Lease, but Tenant shall not be released
from liability. Landlord's consent to a proposed assignment or subletting shall
not be unreasonably withheld.
-8-
<PAGE>
2. No act by Landlord other than giving notice to Tenant shall
terminate this Lease.
On termination, Landlord has the right to recover from Tenant:
(a) The worth, at the time of the award of the unpaid rent that
had been earned at the time of the termination of this Lease;
(b) The worth, at the time of the award of the amount by which
the unpaid rent that would have been earned after the date of termination of
this Lease until the time of award exceeds the amount of the loss of rent that
Tenant proves could have been unreasonably avoided;
(c) The worth, at the time of the award of the amount by which
the unpaid rent for the balance of the term after the time of award exceeds the
amount of the loss of rent that Tenant proves could have been reasonably
avoided; and
(d) Any other amount, and court costs, necessary to compensate
Landlord for all detriment proximately caused by Tenant's default.
"The worth, at the time of the award", as used in (a) and (b) of this
paragraph, is to be computed by allowing interest at the rate of 12% per annum.
"The worth, at the time of the award", as referred to in (c) of this paragraph,
is to be computed by discounting the amount at the discount rate of the Federal
Reserve Bank of San Francisco at the time of the award, plus 1%.
-9-
<PAGE>
3. Landlord, at any time after Tenant commits a default, can cure the
default at Tenant's cost. If Landlord at any time, by reason of Tenant's
default, pays any sum or does any act that requires the payment of any sum, the
sum paid by Landlord shall be due immediately from Tenant to Landlord at the
time the sum is paid, and if paid at a later date, shall bear interest at the
rate of 12% per annum from the date the sum is paid by Landlord until Landlord
is reimbursed by Tenant. The sum, together with interest on it, shall be
additional rent.
4. Rent not paid when due shall bear interest at the rate of 12% per
annum from the date due until paid.
5. Landlord shall be in default of this Lease if it fails or refuses
to perform any provision of this Lease that it is obligated to perform if the
failure to perform is not cured within thirty (30) days after notice of the
default has been given by Tenant to Landlord and to Landlord's lender. If the
default cannot reasonably be cured within thirty (30) days, Landlord shall not
be in default of this Lease if Landlord commenced to cure the default within the
thirty-day period and diligently and in good faith continues to cure the
default.
Tenant, at any time after Landlord commits a default, can cure the
default at Landlord's cost. If Tenant at any time, by reason of Landlord's
default, pays any sum or does any act that requires the payment of any sum, the
sum paid by Tenant shall be due immediately from Landlord to Tenant at the time
the sum is paid, and if paid at a later date shall bear interest at the rate
-10-
<PAGE>
of 12% per annum from the date the sum is paid by Tenant until Tenant is
reimbursed by Landlord. If Landlord fails to reimburse Tenant as required by
this paragraph, Tenant shall have the right to withhold from future rent due the
sum Tenant has paid until Tenant is reimbursed in full for the sum and interest
on it.
LANDLORD'S ENTRY ON PREMISES:
Landlord and their authorized representatives shall have the right to enter
the premises at all reasonable times during working hours for any of the
following purposes:
1. To determine whether the premises are in good condition and
whether Tenant is complying with its obligations under this Lease;
2. To do any necessary maintenance and to make any restoration to the
premises that Landlord has the right or obligation to perform;
3. To serve, post or keep posted any notices required or allowed
under the provisions of this Lease.
NOTICE:
Any notice, demand, request, consent, approval or communication that
either party desires or is required to give to the other party or any other
person shall be in writing and either served personally or sent by prepaid,
first-class mail. Any notice, demand, request, consent, approval or
communication that either party desires or is required to give to the other
party shall be addressed to the other party at the address set forth in the
introductory paragraph of this Lease. Either party may change
-11-
<PAGE>
its address by notifying the other party of the change of address. Notice shall
be deemed communicated within 48 hours from the time of mailing if mailed as
provided in this paragraph.
WAIVER:
No delay or omission in the exercise of any right or remedy of Landlord
on any default by Tenant shall impair such a right or remedy or be construed
as a waiver.
The receipt and acceptance by Landlord of delinquent rent shall not
constitute a waiver of any other default; it shall constitute only a waiver
of timely payment for the particular rent payment involved.
No act or conduct of Landlord, including, without limitation, the
acceptance of the keys to the premises, shall constitute an acceptance of
the surrender of the premises by Tenant before the expiration of the term.
Only a notice from Landlord to Tenant shall constitute acceptance of the
surrender of the premises and accomplish a termination of the Lease.
Landlord's consent to or approval of any act by Tenant requiring
Landlord's consent or approval shall not be deemed to waive or render
unnecessary Landlord's consent to or approval of any subsequent act by Tenant.
Any waiver by Landlord of any default must be in writing and shall not be
a waiver of any other default concerning the same or any other provision of
the Lease.
-12-
<PAGE>
RECORDATION:
This Lease shall not be recorded, except that if either party requests
the other party to do so, the parties shall execute a Memorandum of Lease in
recordable form.
ATTORNEYS' FEES:
If either party becomes a party to any litigation concerning this Lease
or the premises, by reason of any act or omission of the other party or its
authorized representatives, and not by any act or omission of the party that
becomes a party to that litigation or any act or omission of its authorized
representatives, the party that causes the other party to become involved in
the litigation shall be liable to that party for reasonable attorneys' fees
and court costs incurred by it in the litigation.
If either party commences an action against the other party arising out of
or in connection with this Lease, the prevailing party shall be entitled to have
and recover from the losing party reasonable attorneys' fees and costs of suit.
OPTION:
Landlord shall grant to Tenant an option to lease the premises at the end
of the original term for an additional period of five (5) Years. Said Lease
shall be in the same nature as to all terms and conditions as this Lease,
save and except that the rental shall be $2,750.00 per month. Tenant shall
notify Landlord by August 1, 1996 of its intention to exercise its option.
-13-
<PAGE>
IN WITNESS WHEREOF, the parties hereto have hereunto set their hands the
day and year first above written.
/s/ Dolores Mugnaini AMERICAN PLASMA
- ------------------------------ MANAGEMENT INC.
DOLORES MUGNAINI a Utah corporation
/s/ Angelina Capurro By
- ------------------------------ -----------------------
ANGELINA CAPURRO
"Landlord" Its
-------------------
"Tenant"
-14-
<PAGE>
EXHIBIT F
LETTER EXECUTED OCTOBER 20, 1997 BY AND BETWEEN
DANIEL IDEMA AND JOSEPH ROSEN
F-1
<PAGE>
[LETTERHEAD]
October 17, 1997
Mr. Daniel Idema
President
American Plasma Management, Inc.
4764 South 9th Street East
Salt Lake City, UT 84117
Dear Mr. Idema:
This will confirm that we are very interested in pursuing with you the purchase
by Sera-Tec Biologicals of the business and assets of the six donor centers we
discussed, which are owned by American Plasma Management and its affiliates.
The centers in which we are interested are located in Salt Lake City, Utah;
Reno, Nevada; Boise, Idaho; Kalamazoo, Michigan; Lansing, Michigan; and South
Bend, Indiana.
In order to give us sufficient time to review this opportunity and the various
materials you have provided or will be providing to us and to formulate an
appropriate offer, and in view of the significant effort and expense this will
entail on our part, you have agreed that, for a period of thirty (30) days from
the date you sign and return this letter, you will not offer or agree to sell
all or any substantial portion of the business and assets of any of these six
centers to any other person or solicit or encourage any offer to purchase all or
any substantial portion of the business and assets of these six centers from any
other person. During this period, moreover, each of us will cooperate with the
other in furnishing information. Of course, we will endeavor to complete our
review IN LESS THAN THIRTY days if that is possible and make an offer to you
earlier to the extent that we can.
If this letter accurately reflects our understanding, I would appreciate your so
indicating by signing and returning a copy to me.
<PAGE>
Mr. Daniel Idema October 17, 1997
American Plasma Management, Inc. Page 2
I look forward to working with you.
Very truly yours,
SERA-TEC BIOLOGICALS
LIMITED PARTNERSHIP
/s/ Joseph Rosen
---------------------
Joseph Rosen
President
JR:cwr
ACKNOWLEDGED AND AGREED
this 20th day of October, 1997
AMERICAN PLASMA MANAGEMENT, INC.
for itself and its affiliates, including
American Reno, Inc. and
American Plasma Systems, Inc.
By: /s/ Daniel Idema
-----------------------
Daniel Idema, President
<PAGE>
SCHEDULE 2.2
ASSUMED LIABILITIES
LEASES:
1. 769 AND 785 EAST 2ND STREET
RENO, NEVADA
RENT: $2,500.00 TRIPLE NET
TERM: JANUARY 1, 1990 THROUGH DECEMBER 31, 1996.
OPTION: FIVE YEARS WITH MONTHLY RENT SPECIFIED AT $2,750.00.
STATUS: HAVE CONTINUED TO PAY $2,500.00 PER MONTH AND HAVE NOT EXERCISED
FIVE YEAR OPTION.
2. 1021 BROADWAY AVENUE
BOISE, IDAHO
RENT: BASE RENT IS $800.00 PER MONTH ADJUSTED BY "ALL COMMODITY INDEX",
WHICH CURRENTLY TOTALS $1,234.09.
TERM: SEPTEMBER 10, 1983 THROUGH SEPTEMBER 9, 1993, WITH A FIVE YEAR OPTION
WHICH WAS EXERCISED THROUGH SEPTEMBER 9, 1998.
STATUS: CURRENTLY UNDER OPTION AND PAYING $1,234.09 PER MONTH.
NO OTHER LIABILITIES ARE HEREBY BEING ASSUMED.
<PAGE>
SCHEDULE 4.2
PERMITS AND APROVALS
LOCATION FDA LICENSE # CLIA ID# CERTIFICATION ABRA OPP
- ------------------ -------------- ------------ --------------------------
Kalamazoo, Michigan 0732-001 46D0377014 12/30/92-12/30/98 (Attached)
South Bend, Indiana 0898-001 46D0357109 08/06/93-08/06/99 (Attached)
Salt Lake City, Utah 0732-004 46D0524160 03/31/92-03/31/98 (Attached)
Reno, Nevada 0839-001 29D0888240 06/29/92-06/29/98 (Attached)
Boise, Idaho 0898-002 46D0521897 09/22/92-09/22/98 (Attached)
Lansing, Michigan 0732-002 (Ceased Operation)
<PAGE>
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
WASHINGTON, D.C.
ESTABLISHMENT LICENSE
FOR THE MANUFACTURE OF
BIOLOGICAL PRODUCTS
This is to certify that Establishment License No. 839 is hereby issued to
American Plasma-Reno, Inc., the manufacturer, located at Reno, Nevada, through
the establishment identified as American Plasma-Reno, Inc., located at Reno,
Nevada, pursuant to Section 351 of the Public Health Service Act, approved July
1, 1944 (58 Stat. 702, 42 U.S.C. 262), as amended, and the regulations
hereunder. The license authorizes the manufacturer to maintain an establishment
for the propagation or manufacture and preparation for sale, barter, or exchange
in the District of Columbia, or for sending, carrying, or bringing for sale,
barter, or exchange from any State or possession into any other State or
possession or into any foreign country, or from any foreign country into any
State or possession, any virus, therapeutic serum, toxin, antitoxin, vaccine,
blood, blood component or derivative, allergenic product, or analogous product,
or arsphenamine or its derivatives, for which the manufacturer holds an
unsuspended and unrevoked product license issued by the Secretary of Health,
Education, and Welfare pursuant to said Act and regulations.
DATE AUG 13 1980 /s/ [ILLEGIBLE]
------------- ---------------------------------
for DIRECTOR, BUREAU OF BIOLOGICS
FOR FOOD AND DRUG ADMINISTRATION
[SEAL]
<PAGE>
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
WASHINGTON, D.C.
ESTABLISHMENT LICENSE
FOR THE MANUFACTURE OF
BIOLOGICAL PRODUCTS
This is to certify that Establishment License No. 732 is hereby issued to
American Plasma Management, Inc., the manufacturer, located at Salt Lake City,
Utah, through the establishment identified as American Plasma Management, Inc.,
located at Salt Lake City, Utah, with 3 locations which follow,
East Lansing, Michigan
Kalamazoo, Michigan
Salt Lake City, Utah
pursuant to Section 351 of the Public Health Service Act, approved July 1, 1944
(58 Stat. 702, 42 U.S.C. 262), as amended, and the regulations thereunder. The
license authorizes the manufacturer to maintain an establishment for the
propagation or manufacture and preparation for sale, barter, or exchange in the
District of Columbia, or for sending, carrying, or bringing for sale, barter, or
exchange from any State or possession into any other State or possession or into
any foreign country, or from any foreign country into any State or possession,
any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component
or derivative, allergenic product, or analogous product, or arsphenamine or its
derivatives, for which the manufacturer holds an unsuspended and unrevoked
product license issued by the Secretary of Health, Education, and Welfare
pursuant to said Act and regulations.
DATE MAR 28 1980 /s/ [ILLEGIBLE]
---------------- -----------------------------
for DIRECTOR, BUREAU OF BIOLOGIES
FOOD AND DRUG ADMINISTRATION
[SEAL]
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
<PAGE>
DEPARTMENT OF HEALTH AND HUMAN SERVICES
WASHINGTON, D.C.
ESTABLISHMENT LICENSE
FOR THE MANUFACTURE OF
BIOLOGICAL PRODUCTS
This is to certify that Establishment License No. 898 is hereby issued to
American Plasma Systems, Inc., the manufacturer, located at Salt Lake City,
Utah, through the establishment identified as American Plasma Systems, Inc.,
located at South Bend, Indiana and Boise, Idaho, pursuant to Section 351 of
the Public Health Service Act, approved July 1, 1944 (58 Stat. 702, 42 U.S.C.
262), as amended, and the regulations thereunder. The license authorizes the
manufacturer to maintain an establishment for the propagation or manufacture
and preparation for sale, barter, or exchange in the District of Columbia, or
for sending, carrying, or bringing for sale, barter, or exchange from any
State or possession into any other State or possession or into any foreign
country, or from any foreign country into any State or possession, any virus,
therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or
derivative, allergenic product, or analogous product, or arsphenamine or its
derivatives, for which the manufacturer holds an unsuspended and unrevoked
product license issued by the Secretary of Health and Human Services pursuant
to said Act and regulations.
DATE January 17, 1984 [SEAL] /s/ [ILLEGIBLE]
------------------------ ---------------------------------
for DIRECTOR, OFFICE OF BIOLOGICS
NATIONAL CENTER FOR DRUGS AND BIOLOGICS
FOOD AND DRUG ADMINISTRATION
<PAGE>
DEPARTMENT OF
HEALTH AND HUMAN SERVICES
Washington, D.C.
PRODUCT LICENSE
This is to certify that American Plasma Management, Inc., the
manufacturer, located at Salt Lake City, Utah, through the establishment
identified as American Plasma Management, Inc., located at Salt Lake City,
Utah, and holding Establishment License No. 732 is hereby authorized to
propagate or manufacture and prepare for sale
Source Plasma
This Department having been satisfied that the requirements of the Public
Health Service Act, approved July 1, 1944 (58 Stat. 702, 42 U.S.C. 262), as
amended, for the regulation of biological products and of the regulations
thereunder have been met with respect to the product specified above.
Date: April 2, 1986 /s/ [ILLEGIBLE]
--------------------- -----------------------------------------
for DIRECTOR, OFFICE OF BIOLOGICS
RESEARCH AND REVIEW CENTER FOR
DRUGS AND BIOLOGICS
FOOD AND DRUG ADMINISTRATION
<PAGE>
DEPARTMENT OF
HEALTH AND HUMAN SERVICES
Washington, D.C.
PRODUCT LICENSE
This is to certify that American Plasma-Reno, Inc., the
manufacturer, located at Reno, Nevada, through the establishment identified
as American Plasma-Reno, Inc., located at Reno, Nevada, and holding
Establishment License No. 839 is hereby authorized to propagate or
manufacture and prepare for sale
Source Plasma
This Department having been satisfied that the requirements of the Public
Health Service Act, approved July 1, 1944 (58 Stat. 702, 42 U.S.C. 262), as
amended, for the regulation of biological products and of the regulations
thereunder have been met with respect to the product specified above.
Date: November 21, 1985 /s/ [ILLEGIBLE]
--------------------- -----------------------------------------
for DIRECTOR, OFFICE OF BIOLOGICS
RESEARCH AND REVIEW CENTER FOR
DRUGS AND BIOLOGICS
FOOD AND DRUG ADMINISTRATION
<PAGE>
DEPARTMENT OF
HEALTH AND HUMAN SERVICES
Washington, D.C.
PRODUCT LICENSE
This is to certify that American Plasma Systems, Inc., the
manufacturer, located at Salt Lake City, Utah, through the establishment
identified as American Plasma Systems, Inc., located at Salt Lake City,
Utah, and holding Establishment License No. 898 is hereby authorized to
propagate or manufacture and prepare for sale
Source Plasma
This department having been satisfied that the requirements of the Public
Health Service Act, approved July 1, 1944 (58 Stat. 702, 42 U.S.C. 262), as
amended, for the regulation of biological products and of the regulations
thereunder have been met with respect to the product specified above.
Date: August 6, 1985 /s/ [ILLEGIBLE]
--------------------- -----------------------------------------
for DIRECTOR, OFFICE OF BIOLOGICS
RESEARCH AND REVIEW CENTER FOR
DRUGS AND BIOLOGICS
FOOD AND DRUG ADMINISTRATION
<PAGE>
[LETTERHEAD]
February 12, 1997
Reference No. QPPC97086
Daniel Idema
American Plasma Management, Inc.
4764 South 900 East
Salt Lake City, UT 84117
RE: QPP Recertification of the Kalamazoo, Michigan Facility
Dear Mr. Idema:
We are pleased to acknowledge Quality Plasma Program Recertification of the
Kalamazoo, Michigan facility.
Through evaluation and third-party inspection on December 14, 1996 and
after review of corrective actions taken in response to findings during
inspection, it has been determined that the Kalamazoo, Michigan facility
meets the facility and donor criteria for QPP Certification. The QPP
Certification period for this facility began December 30, 1992 and is
effective through December 30, 1998, at which time a recertification
inspection will be scheduled to determine continuing compliance to the QPP
Standards.
By following the QPP criteria, your facility and other QPP-certified
facilities are taking a bold and progressive approach toward providing the
highest quality Source Plasma and, ultimately, plasma products available
anywhere in the world.
Please extend our congratulations to the staff of the Kalamazoo, Michigan
facility.
Best regards,
/s/ Bonnie Sporre
Bonnie Sporre
QPP Coordinator
cc: Scott Maschke
American Biomedical Center
705 North Park Street
Kalamazoo, MI 49007-3449
<PAGE>
[LETTERHEAD]
October 3, 1997
Reference No. QPPC97451
Daniel Idema
American Plasma Management
4764 South 900 East
Salt Lake City, UT 84117
RE: QPP Recertification of the South Bend, IN facility
Dear Mr. Idema:
We are pleased to acknowledge Quality Plasma Program Recertification of the
South Bend, IN facility.
Through evaluation and third-party inspection on August 7, 1997 and after
review of corrective actions taken in response to findings during
inspection, it has been determined that the South Bend, IN facility meets
the facility and donor criteria for QPP Certification. The QPP
Certification period for this facility began August 6, 1993 and is
effective through August 6, 1999, at which time a recertification
inspection will be scheduled to determine continuing compliance to the QPP
Standards.
By following the QPP criteria, your facility and other QPP-certified
facilities are taking a bold and progressive approach toward providing the
highest quality Source Plasma and, ultimately, plasma products available
anywhere in the world.
Please extend our congratulations to the staff of the South Bend, IN
facility.
Best regards,
/s/ Richard Robinson
Richard Robinson
QPP Administrator
RSR/kgm
cc: Toni Mann
American Biomedical Center
515 Lincolnway West
South Bend, IN 46601-1117
<PAGE>
[LETTERHEAD]
May 30, 1996
Reference No. QPP96467
Daniel L. Idema
American Biomedical Center
4764 South 900
Salt Lake City, UT 84117
RE: QPP Recertification of the Salt Lake City, Utah Facility
Dear Dan:
We are pleased to acknowledge Quality Plasma Program Recertification of the Salt
Lake City, Utah facility.
Through evaluation and third-party inspection on May 20, 1996, it has been
determined that the Salt Lake City, Utah, facility meets the facility and donor
criteria for QPP Certification. The QPP Certification period for this facility
began March 31, 1992, and is effective through March 31, 1998, at which time a
recertification inspection will be scheduled to determine continuing compliance
to the QPP Standards.
By following these additional criteria, your facility and other QPP-certified
facilities are taking a bold and progressive approach toward providing the
highest quality Source Plasma and, ultimately, plasma products available
anywhere in the world.
Please extend our congratulations to the staff of the Salt Lake City, Utah
facility.
Best regards,
/s/ Bonnie Sporre
Bonnie Sporre
QPP Coordinator
cc: Christine L. Hemken
American Biomedical Center
606 W. North Temple
Salt Lake City, UT 84116-3455
<PAGE>
[LETTERHEAD]
July 24, 1996
Reference No. QPPC96581
Daniel Idema
American Plasma Reno, Inc.
4764 South 900 East
Salt Lake City, UT 84117
RE: QPP Recertification of the Reno, Nevada Facility
Dear Daniel:
We are pleased to acknowledge Quality Plasma Program Recertification of the
Reno, Nevada facility.
Through evaluation and third-party inspection on June 27, 1996 and after
review of corrective actions taken in response to findings during
inspection, it has been determined that the Reno, Nevada, facility meets
the facility and donor criteria for QPP Certification. The QPP
Certification period for this facility began June 29, 1992 and is effective
through June 29, 1998, at which time a recertification inspection will be
scheduled to determine continuing compliance to the QPP Standards.
By following these additional criteria, your facility and other
QPP-certified facilities are taking a bold and progressive approach toward
providing the highest quality Source Plasma and, ultimately, plasma
products available anywhere in the world.
Please extend our congratulations to the staff of the Reno, Nevada,
facility.
Best regards,
/s/ Bonnie Sporre
Bonnie Sporre
QPP Coordinator
cc: Margaret G. Elkey
American Biomedical Center
785 East 2nd Street
Reno, NV 89502-1018
<PAGE>
[LETTERHEAD]
December 3, 1996
Reference No. QPPC96765
Daniel L. Idema
American Plasma Systems, Inc.
4764 South 900 East
Salt Lake City, UT 84117
RE: QPP Recertification of the Boise, Idaho Facility
Dear Mr. Idema:
We are pleased to acknowledge Quality Plasma Program Recertification of
the Boise, Idaho facility.
Through evaluation and third-party inspection on September 4, 1996 and
after review of corrective actions taken in response to findings during
inspection, it has been determined that the Boise, Idaho facility meets the
facility and donor criteria for QPP Certification. The QPP Certification
period for this facility began September 22, 1992 and is effective through
September 22, 1998, at which time a recertification inspection will be
scheduled to determine continuing compliance to the QPP Standards.
By following these additional criteria, your facility and other
QPP-certified facilities are taking a bold and progressive approach toward
providing the highest quality Source Plasma and, ultimately, plasma
products available anywhere in the world.
Please extend our congratulations to the staff of the Boise, Idaho
facility.
Best regards,
/s/ Bonnie Sporre
Bonnie Sporre
QPP Coordinator
cc: Anne Bryant
American Biomedical Center
1021 Broadway Avenue
Boise, ID 83706-3624
<PAGE>
Schedule 4.3
Financial Statements
Schedules of fixed assets, depreciation schedules, and a schedule of plasma
inventory by location will be provided within seven days of the closing.
<PAGE>
Schedule 4.5
Assumed Contracts
None
<PAGE>
Schedule 4.6
Title to and Condition of Purchased Assets
None.
<PAGE>
Schedule 4.7
Assumed Leases
Leases:
1. 769 and 785 East 2nd Street
Reno, Nevada
Rent: $2,500.00 Triple Net
Term: January 1, 1990 through December 31, 1996.
Option: Five Years with monthly rent specified at
$2,750.00.
Status: Have continued to pay $2,500.00 per month and
have not exercised five year option.
2. 1021 Broadway Avenue
Boise, Idaho
Rent: Base Rent is $800.00 per month adjusted by "All
Commodity Index", which currently totals $1,234.09.
Term: September 10, 1983 through September 9, 1993,
with a five year option which was exercised through
September 9, 1998.
Status: Currently under option and paying $1,234.09 per
month.
3. 515 Lincoln Way West
South Bend, Indiana
Owned Property
4. 705 North Park Street
Kalamazoo, Michigan
Owned Property
5. 606 West North Temple
Salt Lake City, Utah
Owned Property
<PAGE>
SCHEDULE 4.13
INTELLECTUAL PROPERTY
Standard Operating Procedures for the Procurement of Source Plasma, Reactive for
Hepatitis B Surface Antigen (Attached)
All software resident to computer hardware purchased herein
<PAGE>
STANDARD OPERATING PROCEDURES
FOR THE PROCUREMENT OF SOURCE PLASMA,
REACTIVE FOR HEPATITIS B SURFACE ANTIGEN
for
AMERICAN PLASMA MANAGEMENT, INC. AND
AMERICAN PLASMA-RENO, INC.
REVISED 2/93
<PAGE>
TABLE OF CONTENTS
I. Donor Suitability - page 1
Exhibit A - AIDS - pages 2,3
Exhibit B - Informed Consent - page 4
II. Donor Frequency - page 5
III. Donor Precautions - page 5
IV. Staff Precautions - page 6
Exhibit- C - Training Staff - pages 7,8,9
AIDS Information Sheet - page 10
Hepatitis Information Sheet - page 11
Exhibit D - Injury Protocol - page 12
Employee Incident Report - page 13
Precautions to Limit Exposure - page 14
Exhibit E - Cleaning Protocol - page 15
Attachment I - page 16
V. Materials Precautions - page 17
VI. Testing Facility - page 17
Exhibit F - Letter from Testing Lab - page 18
VII. Product Labeling - page 19
Biohazard Label - page 20
VIII. Storage - page 21
IX. Shipping - page 21
X. Records - page 21
XI. Informed Consent - page 22
XII. S.O.P. - page 22
XIII. Donor Processing - page 22
Donor Form FN-404 - page 23
Addenda - pages 24,25,26,27
i
<PAGE>
I. DONOR SUITABILITY
Donors must qualify medically as Source Plasma donors with the exception of
a history of hepatitis and/or a reactive HBsAg test. Donors will be free of
signs and symptoms of acute hepatitis the day of plasmapheresis. Intravenous
drug users (past or present) will not be accepted into the program. Prior to the
initial donation, and monthly thereafter, a medical evaluation will be performed
including a physical examination and review of laboratory reports, the donor's
ALT level will be determined and deviation in excess of twice the predetermined
baseline value, as established by the testing laboratory, will immediately
disqualify the donor. These donors may be reinstated only after evaluation by,
and at the discretion of, the center Medical Director.
The ALT level of an HBsAg-positive donor must not exceed twice the upper
limit of the NORMAL population range, as established by the testing laboratory.
Donors shall receive and document understanding of AIDS educational
materials at each donation. An informed consent for each donation will include
this additional phrase, "I have read, reviewed and understand the information
provided to me regarding the spread of the AIDS virus by donated blood and
plasma, and if I consider myself to be a person at risk for spreading the virus
known to cause AIDS, I agree not to donate blood or plasma for transfusion to
another person or for further manufacture EXCEPT FOR (SPECIFICALLY APPROVED
INDICATIONS)."
An HBsAg-positive donor must be HIV negative. AIDS educational material
specific for serial HBsAg-positive donors must be made available to the donor
at each donation. A signature and date must be received from the donor at each
donation indicating that the donor has received and read the AIDS educational
information (See Exhibit A.)
See Exhibit B. - Revised Consent and Release Form for HBsAg-positive
donors.
Donors will present written approval from their personal physician or the
plasma center's Medical Director if he/she is the donor's personal physician of
record, with regard to volume and schedule of products to be collected.
1
<PAGE>
EXHIBIT A
AIDS EDUCATION FORM SPECIFIC FOR HBsAg-POSITIVE DONORS Age Sex
---- ----
A very serious disease known as AIDS (Acquired Immunodeficiency Syndrome) has
been discovered by the medical community. AIDS is a disease caused by the HIV-1
virus which attacks the body's immune system and makes it unable to fight
disease and infection. There is no known cure for AIDS at this time. People
with this disease carry the HIV-1 virus in their blood and, therefore, may
transmit the disease to anyone who receives blood or plasma that they have
donated.
It is also possible that a person may be infected with the virus but not know
it. They may have a negative HIV test, but the infection can still be present
and transmitted to others. For this reason, we must give you as much
information as is possible so that you can find out if you are at risk for
being infected with HIV-1 virus. If you find that you are a member of one of
the risk groups, or that you have one of the symptoms of AIDS, you MUST NOT
donate plasma. It could be very harmful for someone who may come into
contact with your blood or plasma.
I. RISK GROUPS FOR AIDS
Review with donor, rephrasing or using synonyms appropriate to the local
donor population. Upon concluding review, ask donor whether they are a
member of any group listed.
1. Persons with clinical or laboratory evidence of HIV (AIDS virus) infection
2. Men who have had sex with another man, even one time since 1977
3. Past or present intravenous drug users
4. Persons with hemophilia or related clotting disorders who have received
clotting factor concentrates
5. Men and women who have engaged in sex for money or drugs since 1977
WITHIN THE PAST 12 MONTHS:
6. Persons who have had sex with any person meeting the above descriptions
7. Persons who have had, or have been treated for syphilis or gonorrhea, or
who have had a reactive screening test for syphilis in the absence of a
negative confirmatory test. NOTE: 12 Month deferral must be calculated
from date of diagnosis. Documentation of treatment must be obtained and
STS test must subsequently be negative.
8. Persons who have received a transfusion of whole blood, a blood component
(e.g., cryoprecipitated AMF, platelets) or a clotting factor concentrate
(e.g., Factor IX). NOTE: Receipt of any other FDA-licensed plasma
derivative other than clotting factor (e.g., Albumin) does not require
exclusion.
DONOR RESPONSE: YES NO Reviewer Initials:
----- ------ -------
II. SIGNS AND SYMPTOMS OF AIDS
Review with donor. Upon conclusion of review, ask donor whether they have
experienced any of the symptoms listed.
1. Unexplained weight loss 5. Persistent white spots or
2. Night sweats unusual blemishes in the mouth
3. Blue or purple spots (typical 6. Temperature greater than 100.5
of Kaposi's Sarcoma) on or under degrees Fahrenheit for more
the skin, or on mucous membranes than 10 days
4. Swollen lymph nodes lasting more 7. Persistent cough and shortness
than one month of breath
8. Persistent diarrhea
DONOR RESPONSE: YES NO Reviewer Initials:
------ ------ ------
III. PRE-DONATION AIDS QUESTIONS
Refer to Side 2 of this form.
DONOR RESPONSE: YES NO Reviewer Initials:
------ ------ ------
IV. UNDERSTANDING AIDS FEEDBACK
Obtain verbal feedback for each of the following questions to assess the
donor's understanding of AIDS.
1. What is meant by a "Risk Group" and what are three (3) risk groups for
AIDS?
2. What are four (4) symptoms of AIDS?
3. What is one of the ways a person can get AIDS?
V. DONOR CERTIFICATION STATEMENT
Prior to having donor read and sign below, again provide them with the
opportunity to self-exclude, asking them whether they are a member of any
of the risk groups or have experienced any of the signs and symptoms of
AIDS outlined on this form.
DONOR STATEMENT:
I certify that I UNDERSTAND the information given to me about the spread of AIDS
outlined on this form.
I certify that I AM NOT A MEMBER OF ANY AIDS RISK GROUP.
I certify that I HAVE NOT EXPERIENCED ANY SYMPTOMS OF AIDS.
I understand that the blood or plasma I donate will be used in products FOR
INJECTION TO OTHERS.
IF I THINK I AM AT RISK for transmitting the AIDS virus to others, I WILL NOT
SIGN THIS FORM.
Date Signature of Donor
------------ -----------------------------------
I have reviewed the AIDS questions and feel the donor understands the AIDS
information contained on this form.
Date Signature of Witness
------------ ----------------------------------
(Physician, Physician Substitute, or
Health Professional)
2
<PAGE>
EXHIBIT A - CON'T
PRE-DONATION AIDS QUESTIONS FOR HBsAg-POSITIVE DONORS
(NEW DONORS ONLY)
Obtain a verbal response from the donor for each question asked.
1. Do you have AIDS, or have you ever had a positive test for the AIDS virus,
also known as HIV?
2. Have you ever taken illegal drugs with a needle, even one time?
3. Have you ever taken clotting factor concentrates for a bleeding disorder,
such as hemophilia?
4. At any time since 1977, have you taken money or drugs for sex?
5. MALE DONORS ONLY: Have you had sex with another man, even one time since
1977?
6. Have you had sex in the last 12 months with anyone who HAS HAD AIDS or has
had a positive test for the AIDS (HIV) virus?
7. FEMALE DONORS ONLY: In the last 12 months, have you had sex with a man
who has had sex with another man, even only one time since 1977?
8. Have you had sex in the last 12 months with anyone who has taken illegal
drugs with a needle?
9. At any time in the last 12 months, have you GIVEN money or drugs to someone
to have sex with you?
10. At any time in the last 12 months, have you had sex with anyone who has
TAKEN money or drugs for sex?
11. Have you had sex within the last 12 months with anyone who has taken
clotting factor concentrates for a bleeding disorder, such as hemophilia?
12. In the last 12 months, have you HAD or been TREATED for syphilis or
gonorrhea?
3
<PAGE>
EXHIBIT B
INFORMED CONSENT FOR HBsAg-POSITIVE DONORS
AUTOMATED PLASMAPHERESIS
Plasmapheresis is a procedure by which the plasma, or liquid portion of your
whole blood is separated from the cellular elements of the blood: red blood
cells, white blood cells and platelets. The plasmapheresis process described
in this consent is automated, meaning that the separation is performed
totally by an instrument which is designed for this process. The entire
procedure can be accomplished through only a single needle as follows:
a. Small amounts of your blood will be drawn from your arm and the
HBsAg-positive plasma separated by centrifugation (fast spinning
motion) and possibly also filtration, depending upon the type of
instrument being used.
b. The HBsAg-positive plasma (liquid) portion of your blood will then be
removed into a separate collection or pooling container.
c. The instrument will automatically return the red cells portion of your
blood back to you.
d. Steps a, b and c will then be repeated until the correct amounts of
HBsAg-positive plasma is collected, based on your [ILLEGIBLE]
(% of red cells) and/or body weight.
The purpose of plasmapheresis is to obtain only the HBsAg-positive plasma
portion of your blood without depriving you of your red blood cells. It takes a
longer time for your body to regenerate red blood cells to replace those lost.
Plasma, however, is replaced much faster. You can donate HBsAg-positive plasma
two times in any 7 day period. There must be at least 2 days between these two
donations.
Some of your blood or plasma will be used at each donation for the performance
of blood tests. Once your plasma has been tested for hepatitis and found to be
positive, it will no longer be tested for this disease; however, in addition to
tests for syphilis, plasma protein and other infectious agents as required, we
will be performing a test for the antibody to HIV. Researchers have found these
antibodies in individuals who have been exposed to the AIDS virus. A reactive
HIV test is a preliminary finding and does not confirm infection with AIDS.
Should we obtain a reactive result for your HIV test, you will be notified in a
confidential manner and referred to your personal physician or appropriate
public health agencies. Unsuitable test results for the HIV test will result in
your name being entered into our donor rejection files, meaning you will not be
able to donate blood or plasma at ours or other facilities. You will be advised
not to donate blood or plasma in the future for protection of the recipients of
these blood products. We will also advise you to inform your sexual partner(s)
of your test status. If your partner is a donor of this center, we will be
required to defer him/her from further donation also. Unsuitable results for
any of the tests we perform may be required to be reported to public health
agencies. A sample of your plasma will also be used for drug testing. A
positive drug serum will result in permanent rejection from further donations at
this center. Your plasma will be used for non-injectable purposes. It will
also be used in diagnostic kits.
Anytime you draw blood from the human body and reinfuse blood into the human
body, there is always risk involved. The risks include:
1. Dizziness, nausea and fainting during the procedure and upon standing or
walking afterwards.
2. Inability to return red cells to you will stop your plasmapheresis
donation. This may lower your hemoglobin so that it may be necessary to
wait eight weeks until you will be permitted to donate plasma again. It
must be understood that this might be due to equipment failure,
infiltrations or clotting of the blood within our bleeding system.
Monetary reimbursement will not be made for donations missed during this
time.
3. A blood clot may form under the skin on your arm at the venipuncture site.
This may become swollen and tight until it is absorbed and carried away by
the fluids in your body tissues. There is also a small chance that a blood
clot could be carried to other organs in your body and damage them. If
your arm or hand should become cold and/or discolored, see a doctor
immediately and notify or come into our plasmapheresis center during
business hours.
4. An infection may develop at the venipuncture site and may possibly spread
to other places, even after thorough preparation of the skin.
5. It may be necessary to insert a needle into a second vein if a problem does
develop during our procedure.
6. There is a possibility that the equipment and materials which we are using
(although supplied by FDA-approved manufacturers) may be contaminated
and cause serious illness to you.
7. There is a possibility of you having an adverse reaction, either to the
anticoagulant that is reinfused with your blood, or to the reinfusion of
your own red cells. Reactions due to any anticoagulant that is reinfused
may be reduced by advising the phlebotomists assigned to you, who then may
be able to reduce pump speed.
Prior to your donation, the phlebotomist will inform you about the indicator
lights and/or alarm on the automated instrument and how you can assist in
monitoring the flow of your blood.
A physical examination you must take prior to donation will determine whether
you are physically able to donate your plasma on a regular basis. Anytime
your health or physical status changes, such as [ILLEGIBLE], /hematocrit
and/or hemoglobin, weight or any other physical change that does not meet our
standard as defined in our SOP manual, your deferral or removal from the
program may become necessary. If difficulties develop in the plasmapheresis
process, the center's physician, physician substitute or a physician at a
local hospital will be treating you.
HBsAg-Positive Donors must never donate blood or blood products for further
manufacture or for transfusion.
YOU ARE FREE TO DISCONTINUE PARTICIPATION IN THE PLASMAPHERESIS PROGRAM AT ANY
TIME! THE LONG-TERM EFFECTS OF DONATING HBsAg-POSITIVE PLASMA ON HBsAg-POSITIVE
INDIVIDUALS IS UNKNOWN.
DONOR'S STATEMENT OF CONSENT AND UNDERSTANDING
I have read, or have had read to me, this informed consent. This procedure is
perfectly clear to me, and the risks involved were explained to me by the
Center's Physician, Physician Substitute or Health Professional. I agree that
the Center Physician or Physician Substitute is authorized to give me any
treatment necessary to respond to any difficulties or adverse reactions I may
experience in the process.
Information about the disease AIDS has been explained to me by the Physician,
Physician Substitute or Health Professional; and I understand that I should not
donate if I am a member of any risk group or have any symptoms of this disease,
as was discussed with me.
Should the results of any of the tests performed on my blood or plasma be
returned as unsuitable, I prefer to be contacted as indicated below. I
understand that I will be asked to make a personal appearance at this center to
receive information concerning the identity of test results.
Please check preference: Notify me by Phone Letter
----- -----
I want to participate in the plasmapheresis program at this American Plasma
affiliate center. I have been provided with a clear opportunity to ask
questions and to refuse participation and further understand that I may
discontinue my participation at any time.
DATE Signature of Donor
--------------- -------------------------
Signature of Witness
-------------------------
(Physician, Physician Substitute
or Health Professional)
4
<PAGE>
II. DONOR FREQUENCY (MAXIMUM)
Two donations per week, not to exceed twice in seven days nor within 2 days
of each other, with the donor's personal physician's approval or the medical
director's approval if he/she is the donor's physician of record.
III. DONOR PRECAUTIONS
HBsAg reactive donors will be isolated in time and/or distance from all
other donors. HBsAg reactive donors will be assigned charts, bleed numbers and
donor numbers easily identifiable as exclusive to this program. Normal blood
will not be centrifugated in the same centrifuge at the same time as HBsAg
reactive blood. HBsAg-positive blood will be double wrapped in absorbent packing
material when centrifugated.
American Plasma's donor floor is divided into sections by four (4) foot
walls. During the donation of an HBsAg-positive donor, that donor will be the
only donor in that section. HBsAg-positive donors must try to be scheduled at
times other than regular posted operational hours. During an HBsAg-positive
donation, the floor supervisor will be assigned specifically to deal with this
donor. This will be the supervisor's only responsibility while the HBsAg-
positive donor is donating. This supervisor will have nothing to do with any
other section should it occur that normal donors are on the donor floor at the
same time as an HBsAg-positive donor. The phlebotomist will wear a disposable
gown, face mask, goggles and gloves while working with an HBsAg-positive donor.
5
<PAGE>
IV. STAFF PRECAUTIONS
Only a trained floor supervisor, specifically trained to deal with
an HBsAg-positive donor, will be involved with that donor. Training
shall occur prior to any involvement with the processing of an
HBsAg-positive donor. Retraining shall occur prior to any involvement
with an HBsAg-positive donor if more than thirty (30) days has lapsed
between donations of an HBsAg-positive donor.
Detailed safety instructions are documented and signed by staff members
involved in this program. Each of these staff members has available any and all
medical treatments as well as applicable immunizations when dealing with donors
in this program.
Staff handling HBsAg reactive donors, blood or blood-contaminated materials
will wear gloves, gowns, goggles and masks. After finishing the procedure, all
involved personnel will immediately wash their hands with an FDA-approved
germicidal soap. All CDC and state OSHA standards will be adhered to.
The training program is updated by the Responsible Head in conjunction with
the Medical Director, who is a board-certified Hematologist and Pathologist.
Updates are done when there is a change in procedure required by the FDA, or the
purchaser of the HBsAg-positive units or if there is a change in any legal
shipping requirement. Each of these updates will be submitted to the F.D.A.
for approval. Once approved, each staff member involved in dealing with an
HBsAg-positive donor will be schooled in these new procedures. In that drawing
HBsAg-positive donors is not a continuous ongoing program, the procedures are
reviewed at the out set of the program and then reviewed every 60 days for
changes and/or consistency. (See Exhibit C.)
See Exhibit D. regarding the safety program for dealing with inadvertent
injury.
See Exhibit E. for cleaning protocol.
CONTROL AND THE DEPARTMENT OF TRANSPORTATION
No sample or unit will be shipped without the appropriate label, packaging
container and documentation.
6
<PAGE>
EXHIBIT C
HBsAg-Positive
Training Schedule for Prep. Tech.
The signatures of the trainee and supervisor indicate that the procedures
of the section have been clearly explained and the trainee has been observed and
evaluated in the performance of those procedures. This signifies that in those
sections signed, the trainee can perform the procedures with competence and
without the need for direct supervision. The trainee also understands that this
is a high-risk training procedure for processing HBsAg-positive donors.
SECTION 1 (crit. station) Date Started_____ Date Completed_____
prime directive, crit. position, Trainee Sig.___________________________
finger stain check, collecting Supervisor Sig.________________________
crit. sample, bloodtyping,
reading crits., FDA limits,
resticks, pulling charts,
writing labels, annual phys.
stamp, review and evaluate
SECTION 2 (vitals) Date Started_____ Date Completed_____
taking BP, pulse, temp. and FDA Trainee Sig.__________________________
limits, code stamp, T.T. stamp, Supervisor Sig._______________________
phys. sheet, review and evaluate
SECTION 3 (new donors) Date Started_____ Date Completed_____
prior to vital, following Trainee Sig.__________________________
physical, review and evaluate Supervisor Sig. ______________________
SECTION 4 (questions) Date Started_____ Date Completed_____
keeping D.R.F. current, Trainee Sig.__________________________
questions, weigh-in, arm Supervisor Sig. ______________________
check, review and evaluate
SECTION 5 (bags) Date Started_____ Date Completed_____
making up bags, flow to floor, Trainee Sig.__________________________
changing lot numbers, review Supervisor Sig._______________________
and evaluate
SECTION 6 (money box) Date Started_____ Date Completed_____
paying donors Trainee Sig.__________________________
Supervisor Sig._______________________
SECTION 7 Date Started_____ Date Completed_____
opening and closing Trainee Sig.__________________________
procedures, keeping logs, Supervisor Sig._______________________
review and evaluate
Retraining shall occur if an HBsAg-positive donor is not processed for 30
days. Review of training shall occur every 60 days for updates and to maintain
consistency. Retraining and reviews will use this same form and will be kept in
the trainee's personnel file.
7
<PAGE>
EXHIBIT C
HBsAg-Positive
Training Schedule for Phlebotomist
The signatures of the trainee and supervisor indicate that the procedures of
the section have been clearly explained and the trainee has been observed and
evaluated in the performance of those procedures. This signifies that in those
sections signed, the trainee can perform the procedures with competence and
without the need for direct supervision. The trainee also understands that this
is a high-risk training procedure for processing HBsAg-positive donors.
SECTION 1 Date Started_________Date Completed__________
prime directive, sterile- Trainee Sig._________________________________
aseptic awareness, spiking Supervisor Sig.______________________________
bottles, rinsing bags,
donor D.C., log, review and
evaluate.
SECTION 2 Date Started_________Date Completed__________
pulling bags, switching over, Trainee Sig._________________________________
bag wt. and scale function, Supervisor Sig.______________________________
test tubes, review and evaluate
SECTION 3 Date Started_________Date Completed__________
HIR and DTH, blood bag ID, bag Trainee Sig._________________________________
return, infiltrations, review Supervisor Sig.______________________________
and evaluate
SECTION 4 Date Started_________Date Completed__________
vital signs and prep data, Trainee Sig._________________________________
setups and arm prep, arm Supervisor Sig.______________________________
positioning, priorities,
review and evaluate
SECTION 5 Date Started_________Date Completed__________
venipuncture, vacutainers, new Trainee Sig._________________________________
donor explanation, needle Supervisor Sig.______________________________
positioning, review and evaluate
SECTION 6 Date Started_________Date Completed__________
dealing with donors, efficiency Trainee Sig._________________________________
and organization, advanced Supervisor Sig.______________________________
electives, review and evaluate
Retraining shall occur if an HBsAg-positive donor is not processed for 30
days. Review of training shall occur every 60 days for updates and to maintain
consistency. Retraining and reviews will use this same form and will be kept in
the trainee's personnel file.
8
<PAGE>
EXHIBIT C
HBsAg-Positive
Training Schedule for Lab Tech.
The signatures of the trainee and supervisor indicate that the procedures of
the section have been clearly explained and the trainee has been observed and
evaluated in the performance of those procedures. This signifies that in those
sections signed, the trainee can perform the procedures with competence and
without the need for direct supervision. The trainee also understands that this
is a high-risk training procedure for HBsAg-Positive donors.
SECTION 1 (window) Date Started_________Date Completed__________
transfer of info. from blood Trainee Sig._________________________________
bags to pooling bags, FDA Supervisor Sig.______________________________
limits, use of scale &
conversion charts, weighing
whole blood and recording in
log, overdraws, balancing &
loading centrifuge, legibility,
correction procedures, weighing
& converting plasma to ml. &
logging, placing plasma in
freezer, window priorities,
window logs (scale log, etc.),
review and evaluate
SECTION 2 (expressors) Date Started_________Date Completed__________
removing bags from centrifuge & Trainee Sig._________________________________
placing inexpressors, sterile & Supervisor Sig.______________________________
aseptic procedures, expressing
plasma & collecting RIA samples,
crosspools, use of sealer,
priorities, review and evaluate
SECTION 3 Date Started_________Date Completed__________
RIA samples and sheets, serum Trainee Sig._________________________________
samples & SPE-RPR sheets, HbsAg Supervisor Sig.______________________________
isolation & destruction, logs,
opening and closing procedures,
review and evaluate
SECTION 4 Date Started_________Date Completed__________
packing preparation, logs, Trainee Sig._________________________________
packing, FDA regulation review, Supervisor Sig.______________________________
inventory, slow time duties
SECTION 5 (optional) Date Started_________Date Completed__________
RVR's mailing Trainee Sig._________________________________
Supervisor Sig.______________________________
Retraining shall occur if an HBsAg-positive donor is not processed for 30
days. Review of training shall occur every 60 days for updates and to maintain
consistency. Retraining and reviews will use this same form and will be kept in
the trainee's personnel file.
9
<PAGE>
AIDS INFORMATION SHEET
FOR EMPLOYEES WORKING WITH HBsAg-POSITIVE DONORS
With the growing fear of AIDS infecting the healthcare industry, our best
defense is knowledge. You have just accepted a job in the plasma industry; and
it is your responsibility to be informed and cautious, as it is our
responsibility to provide you with a safe working environment. In order to
maintain these safety standards, you will be required to follow all safety
procedures as outlined in the NABI Standard Operating Procedure Manual (SOP).
These procedures have been designed to comply with the most current federal
regulations. Additionally, you will be required to follow all safety procedures
as outlined in American Plasma's HBsAg-Positive Donor SOP.
First, let's define what AIDS is:
AIDS (Acquired Immune Deficiency Syndrome) is a blood-borne, sexually
transmitted disease in which a virus (HIV-1/HIV-2) invades the body and
damages the immune system rendering the victim susceptible to many other
infectious agents eventually causing death. Symptoms include night sweats,
unexplained weight loss of 10 pounds or more within a 2 month period,
enlarged lymph nodes lasting more than one month, fatigue or shortness of
breath, diarrhea, purplish or blue spots under the skin or on the mucous
membranes (Kaposi's Sarcoma), fever greater than 100.5F for more than 10
days, a persistent cough, persistent white spots or unusual blemishes in the
mouth and persistent diarrhea. No cure or vaccine exists for AIDS at this
time.
1. Persons who have been victims of rape during the preceding 12 months will
be deferred as donors.
2. Persons who have had contact with blood or other body fluids through a
needle stick, open wound, non-intact skin or mucous membranes during the
preceding 12 months will be deferred.
3. Persons with clinical or laboratory evidence of HIV infection will be
deferred.
4. Men who have had sex with other men, even one time since 1977, will be
deferred.
5. Past or present intravenous drug users will be deferred.
6. Persons with hemophilia or related clotting disorders who have received
clotting factor concentrates will be deferred.
7. Men and women who have engaged in sex for money or drugs since 1977 and
persons who have engaged in sex with such people during the preceding 12
months will be deferred.
8. Persons who have had or have been treated for syphilis or gonorrhea during
the preceding 12 months will be deferred.
9. Persons who have received a transfusion of whole blood or blood components
within the past 12 months will be deferred.
10. Persons who have engaged in sex with any individual who is included in any
one of the high risk categories 1-9 above within the preceding 12 months
will be deferred.
There is an interval during early infection during which test results for HIV
may be negative although an infection may be transmitted. Each donor's blood
will be tested for HIV-1 and HIV-2 and if found to be positive will be deferred.
Names of repeatedly reactive donors will be made part of a donor deferral
registry.
AIDS has created great concern in the healthcare industry due to the fact that
AIDS is transmitted through semen and blood products, and healthcare workers
have a greater chance of being exposed. Being part of the plasma industry, our
concern is two-fold. We have a responsibility for the safety of the PRODUCTS we
collect, and also to our EMPLOYEES. The primary way we accomplish this is
through extensive donor screening and testing. Accepting only healthy
individuals as donors helps protect the products and you, the employee, from
risk. All donors are carefully screened by a staff physician (or medical
personnel) prior to being accepted for plasmapheresis. This screening procedure
includes a medical questionnaire as well as a physical examination to determine
whether a donor is a member of any high risk group for AIDS. Any donor who
appears to be at risk for infection will not be accepted. Once accepted, a
donor is screened prior to each donation to detect any change in their health
status. In addition, a sample of plasma or serum is collected from the donor at
each donation and tested so that any sign of infection can be detected at the
earliest possible stage.
As part of your orientation, you will be required to read portions of the NABI
SOP and the American Plasma HBsAg-Positive Donor SOP. There are sections which
outline precautionary measures you must follow whenever there is a chance that
you might be exposed to blood and body fluids. American Plasma provides all the
protective equipment you will need while on the job. Lab coats are to be worn
in the work areas. Gloves, gowns, goggles and masks must be worn if direct
contact with blood or other body fluids is possible. Frequent handwashing
during the work shift as well as prior to leaving the work area is essential.
Needles and syringes must be disposed of carefully and in the proper containers;
and all infectious waste must be incinerated or autoclaved to destroy any
potential pathogens. Federal and state regulations mandate proper disposal
procedures for infectious waste; and we at American Plasma are conscientious in
our efforts to comply with these guidelines insuring both employee and community
health and safety.
We acknowledge and share the concerns of all our employees concerning the AIDS
virus and hope we have provided you with some valuable information about your
new workplace. We want to assure you that we will do all in our power to
maintain our centers as safe working environments.
Please sign below to indicate you have read and understand the above
information.
Signature:
Date:
REV. 2/93
10
<PAGE>
HEPATITIS INFORMATION SHEET
FOR EMPLOYEES WORKING WITH HBsAg-POSITIVE DONORS
Hepatitis, a viral infection of the liver, has been a great concern of the
healthcare industry for quite some time. It is present in various forms: A, B,
C and Non-A/Non-B. However, Hepatitis B presents the greatest risk to workers
in the healthcare industry. The hepatitis virus very often does not present any
symptoms in an infected person. If symptoms are present, the usual ones that
occur include fatigue, mild fever, muscle and joint aches, nausea, vomiting,
loss of appetite, vague abdominal pain, occasional diarrhea and jaundice.
Hepatitis B can be a serious disease due to its potential for life-threatening
complications, including massive hepatic necrosis, cirrhosis of the liver,
chronic active hepatitis and hepatocellular carcinoma. Of those affected with
Hepatitis B, most (approximately 88%) recover, some become chronic carriers of
the virus (approximately 10%) with the potential to spread the infection to
others for an indefinite period of time, and a few die (approximately 2%).
Due to the mode of transmission of Hepatitis B, employees in the health care
industry have been at a higher risk for infection. Hepatitis B is usually
spread through contact with infected blood or blood products. It may also be
spread through illicit injectable drug use, tattooing and ear piercing.
Hepatitis B is also potentially present in other body fluids such as urine,
tears, semen, vaginal secretions and breast milk. Therefore, transmission of
the disease may also occur through sexual contact.
Since similarities in transmission do exist between hepatitis and AIDS, the same
precautions must be taken by American Plasma and all its employees to maintain a
safe working environment for all employees. Normally, all donors are subject to
a very selective process including a medical questionnaire, as well as a
physical examination prior to approval for the plasmapheresis program to
eliminate possible carriers. In addition, a sample of plasma or serum is
collected from the donor at each donation to test for Hepatitis B Surface
Antigen (HBsAg) so that any sign of infection can be detected at the earliest
possible stage. In the case of an HBsAg-positive donor, this test is not
necessary in that the donor is known to be HBsAg-positive. Consequently,
extreme caution and strict attention to precautionary procedures when working
with such a donor is mandatory.
As part of your orientation, you may be required to read portions of the NABI
Standard Operating Procedures as well as the American Plasma HBsAg-Positive
Donor SOP. There are sections which outline precautionary measures you must
follow whenever there is a chance that you might be exposed to blood or body
fluids. American Plasma provides all the protective equipment you will need
while on the job. Lab coats are to be worn in the work areas. Gloves must be
worn as well as face protection. Frequent hand-washing during the work shift as
well as prior to leaving the work area is essential.
Needles and syringes must be disposed of carefully and in the proper containers,
and all infectious waste must be incinerated or autoclaved to destroy any
potential pathogens prior to disposal. Federal and state regulations mandate
proper disposal procedures for infectious waste; and we at American Plasma are
conscientious in our efforts to comply with these guidelines to ensure both
employee and community health and safety.
There are two forms of vaccine for Hepatitis B that will provide your body with
the necessary elements to combat the virus in the event you are exposed. Both
of these vaccines are very effective, providing greater than 90% protection
against Hepatitis B for at least 7 years.
The first type of Hepatitis B vaccine is made from surface antigen of the virus
which has been collected and purified from the plasma of human carriers of
Hepatitis B virus, but who have no symptoms. This vaccine will not transmit any
active viral components of any type. The other choice of vaccine is a synthetic
antigen identical to the Hepatitis B surface antigen. Either vaccine would
cause your body to produce Hepatitis B antibodies which would combat the
invasion of the Hepatitis B virus.
American Plasma is committed to ensuring the safety and health of our employees
to the best of our ability. Therefore, American Plasma will provide the
Hepatitis B vaccine at no expense to our employees. While in some positions
(ie., corporate office administrative positions), the risk of exposure to any
blood products may be minimal or non-existent, there are some job positions that
we have determined to be at significant risk of being exposed to blood products
while performing their job duties. We strongly recommend employees working with
HBsAg-positive donors to consider receiving Hepatitis B vaccine.
Please sign below to indicate you have read and understand the above
information.
Signature:
Date:
11
<PAGE>
EXHIBIT D
Inadvertent Injury Protocol for Staff
Involved With HbsAg-Positive Donor
1. Any trained staff member working with an HBsAg-Positive Donor must wear a
gown, gloves, goggles and mask during all procedures. At the completion of
a donation all disposable materials must be discarded into a hazardous
waste container. This waste container will then be incinerated. Be
careful in disposing of materials so no injury or contamination occur.
(See Attachment I for documenting disposal of materials.)
2. If an inadvertent injury of any kind is incurred during the donation, the
manager must be notified immediately. The employee will then be evaluated
by the Medical Director for any possible treatment. Employee will either
be treated at the center or sent to the hospital. Workman's Compensation
forms must be completed as soon as reasonably possible. The employee will
be seen weekly by the Medical Director unless advised otherwise by same.
3. Immunization with Hepatitis B vaccine will be made available to any trained
staff member working with an HBsAg-Positive Donor. Upon request by the
employee the Medical Director will arrange for immunization to occur.
4. Documentation will be updated as the circumstances change with regard to the
he condition of the employee. The updated information will be kept in the
employee's personnel file.
5. Procedural training and safety training of staff members working with
HBsAg-Positive Donors will occur as stated in the Safety and Training Form.
12
<PAGE>
EMPLOYEE INCIDENT REPORT
FOR EMPLOYEES WORKING WITH HBsAg-POSITIVE DONORS
EMPLOYEE NAME:_________________________________________________________________
Take action and complete information appropriate for type of exposure.
I. EXPOSURE TO BLOOD OR BLOOD PRODUCTS OF A DONOR WITH NEGATIVE TEST RESULTS
WITHIN THE LAST 45 DAYS.
ACTION A: If exposure is a "needle stick" clean wound. With recent
negative results no further action should be necessary.
ACTION B: If exposure is a "needle stick" dirty wound, i.e. a donor with
known positive HBsAg test results, notify manager immediately.
Employee is to be sent to Medical Director for exam and follow-up
according to Medical Director's recommendations.
Date of last negative results:_______________ Bleed number:____________________
Exposure Date:____________ Bleed number:_____________ Test results:____________
II. EXPOSURE TO BLOOD OR BLOOD PRODUCTS OF A DONOR WITHOUT TEST RESULTS WITHIN
THE LAST 45 DAYS.
ACTION: Send donor's back-up sample to a local lab NOW and have it tested
for core and surface antigen for Hepatitis B. If negative, take
no further action. If possible, send employee for H-Big A.S.A.P.
Exposure Date:_____________ Bleed Number:________________
Test result for core antigen:________________ Surface antigen:_________________
If possible: Date employee was treated:___________________ .
III. EXPOSURE TO BLOOD OR BLOOD PRODUCTS OF AN UNKNOWN DONOR
ACTION: Send employee for a Gamma Globulin shot immediately.
Send employee to see Medical Director or P.A. for
evaluation and follow-up according to Medical Director's
recommendations.
I have received treatment as indicated above.
Employee sig.
------------------------------------
Date: Director's sig.
------------------ ---------------------------------------
I have refused treatment as indicated above.
Employee sig. Date:
--------------------------------------- -------------------
Director's sig.
-------------------------------------------
13
<PAGE>
PRECAUTIONS TO LIMIT EXPOSURE TO
BLOOD AND BLOOD PRODUCTS
In our business, we work with a healthy pool of donors who are regularly
screened for Hepatitis B and HIV. Donors with reactive test results are
suspended from continued donations. As a result, the pool of donors is probably
more free of these diseases than an equivalent pool of the general population.
Nonetheless, ANY exposure to blood products is potentially infectious and is to
be avoided. The following is a list of steps you can take to reduce the chances
of an exposure.
1. WASH HANDS FREQUENTLY. Immediately after contact with blood or blood
products and prior to eating or using restrooms. Avoid rubbing eyes until hands
are washed. Never put your pen in your mouth.
2. KEEP YOUR LAB COAT CLEAN. Blood from tools or spray can result in an
exposure from your lab coat. Remove it and then wash your hands prior to
eating. Don't put gum, cigarettes, etc. in a pocket you've used for tools.
3. AVOID OPEN TOED SHOES. If you do wear them, you must wear socks.
4. USE OF GLOVES IS MANDATORY IN ANY CIRCUMSTANCE IN WHICH CONTACT WITH BLOOD
OR BLOOD PRODUCTS IS POSSIBLE. This includes drawing hct. samples, reading
hct.s and total proteins, urinalysis, expressing, phlebotomy and cleaning up
blood or plasma spills. Gloves are available at anytime should you desire to
wear them.
5. USE CORRECT PROCEDURE TO DISPOSE OF BIOHAZARDOUS MATERIAL. Take care with
needles, following good technique eliminates "sticks". Put all waste materials
in biohazard bags so that they can be incinerated properly (See Attachment I for
disposal documentation).
6. REPORT ANY EXPOSURE TO THE CENTER DIRECTOR IMMEDIATELY; MUCOSAL, SPLASH OR
PUNCTURE. If possible, report the name and bleed number of the donor whose
blood or plasma you were exposed to.
7. HIV AND HEPATITIS B TESTING ARE AVAILABLE. Should you desire to be tested
yourself, all you have to do is donate. Results will be handled with the same
degree of confidentiality as any donor.
SIGN BELOW TO INDICATE THAT YOU HAVE READ AND UNDERSTAND THESE PRECAUTIONS.
SIGNATURE;
DATE:
14
<PAGE>
EXHIBIT E
Cleaning Protocol for Employees Working with HBsAg-Positive Donors
NOTE: ALWAYS WEAR GLOVES, MASK AND DISPOSABLE GOWN WHEN CLEANING ANY
MATERIALS USED ON AN HBsAg-POSITIVE DONOR.
1. Disposable Materials
All disposable materials used in processing or plasmapheresing an
HBsAg-Positive Donor must be disposed of in a biohazardous container.
This container must then be incinerated (See Attachment 1 for disposal
documentation).
Disposable materials will include but are not limited to: empliary
tubes, gloves, gowns, masks, arm prep materials, tape and soft goods.
Hands must be washed thoroughly with a germicidal soap after disposing
of gown, gloves and mask in a biohazardous container. Do not touch
anything prior to washing your hands.
2. Non-disposable Materials
All non-disposable materials used on an HBsAg-Positive Donor which can
be autoclaved will first be cleaned with a 1:10 bleach/water sodium
hypochlorite solution and then be autoclaved. (1:10 sodium
hypochlorite solution #1 household clorox bleach/10 water - ask
manager for it).
Any non-disposable materials used on an HBsAg-Positive Donor which
cannot be autoclaved will be cleaned with a 1:100 sodium hypochlorite
solution. Non-disposable materials will include but are not limited
to: microhematocrit centrifuge, refractometer, auxiliary scale, donor
weight scale, donor chair, plasma centrifuge, ecoles, plasma
centrifuge cups and expressors.
a. Oral mercury thermometers Place in 1:100 BLEACH/WATER
SOLUTION between each use,
(Disinfects in event sheath was not
intact.)
b. Refractometers Use DISTILLED WATER ONLY to cleanse
between each sample reading.
c. Work counters Use GERMICIDE to clean counters of
any dirt or debris. Disinfect with
1:00 BLEACH/WATER SOLUTION. Clean
throughout day as needed, and
disinfect all surfaces at end of
day.
d. IVAC Instrument, BP cuffs, Use GERMICIDE to clean equipment of
hematocrit centrifuge, any dirt or debris. Disinfect with
capillary tube reader, 1:10 BLEACH/WATER solution.
black light, shelves.
e. Bleach/Water Solutions Pour remaining solution down drain,
(1:100 and 1:10) mix new solution and place label on
each bottle or container indicating
1:100 or 1:10 and 7-day change due
date.
f. Donor beds Use GERMICIDE to clean any dirt or
debris. Disinfect arm rests or any
other area of bed that becomes
blood-contaminated with 1:100
BLEACH/WATER solution. Clean
throughout day as needed and all
surfaces at end of day.
g. Work counters, supply Use germicide to clean any dirt or
carts or stands debris. Disinfect with 1:10
BLEACH/WATER SOLUTION.
h. Scales, IV poles, shelves, Use GERMICIDE to clean equipment
hemostats of any dirt or debris. Disinfect
with 1:10 BLEACH/WATER solution.
i. Hematron & hematron shield, Use GERMICIDE to clean any dirt or
extractors, inside of debris. Use HYDROGEN PEROXIDE to
refrigerated centrifuge & foam-out any blood or plasma
serofuge, bottle racks, residue. Disinfect with 1:10
sample boards, work BLEACH/WATER solution.
counters, hemostats scissors
3. Blood spills or plasma spills will be cleaned up with a 1:10 sodium
hypochlorite solution on a disposable absorbent material such as a
Kim-Wipe while wearing protective gown, gloves and mask. These items
will be disposed of in a biohazardous container and ultimately
incinerated. (See Attachment 1 for disposal documentation).
For additional cleaning information RE: #1,2,3 above see [ILLEGIBLE]:
SOP N-106, pages 2 -13.
4. Each disposal procedure in #1, 2 and 3 above must be documented in the
disposal log book after each donation, specific for each donor. (See
Attachment 1 for disposal documentation.) Below is the procedure for
completing the disposal log:
a. The center name and address must be completed on the service
company disposal log.
b. A blood number specific for each donor must be attached to the
disposal log for any donor for which materials are going to be
incinerated. The corresponding donor number specific for each
blood number must be entered in the destruction log next to the
blood number.
c. Under "COMPONENT" on the destruction log, all materials to be
incinerated are to be entered.
d. Under "REASON" on the destruction log, the reason for destroying
the material must be entered (be specific).
e. Enter the date the components were packaged in a biohazardous
container and the individual who packaged the materials should
initial and date the disposal log under the area labeled
"PACKAGED FOR DISPOSAL".
f. When the packaged materials are ready for pick-up by the disposal
company, the center manager should review and check all
procedures and when satisfied everything is satisfactory he/she
should initial the disposal log.
g. When the packaged materials are picked up by the disposal
company, the driver should date and initial the disposal log.
h. A receipt validating the destruction date is returned
center by the incineration service company.
15
<PAGE>
SERVICE COMPANY DISPOSAL LOG
[ILLEGIBLE]_______________
INSTRUCTIONS: All blood and blood components rejected as unsuitable for
distribution that are disposed of through an incineration service
will be documented in this record. Management will initial to
verify item was packaged for disposal. The date of pick-up will
be documented on line entry of last item being picked-up. A
receipt validating destruction must be returned to center by
incineration service company.
<TABLE>
<CAPTION>
<S><C>
- ---------------------------------------------------------------------------------------------------------------------------------
PACKAGED FOR DISPOSAL SERVICE PICKUP
-------------------------------------------------------------
BLOOD NO. DONOR NO. COMPONENT REASON DATE TECH INT MGHT INT DATE NOTED BY
- ---------------------------------------------------------------------------------------------------------------------------------
- ---------------------------------------------------------------------------------------------------------------------------------
- ---------------------------------------------------------------------------------------------------------------------------------
- ---------------------------------------------------------------------------------------------------------------------------------
- ---------------------------------------------------------------------------------------------------------------------------------
- ---------------------------------------------------------------------------------------------------------------------------------
- ---------------------------------------------------------------------------------------------------------------------------------
- --------------------------------------------------------------------------------------------------------------------------------
- ---------------------------------------------------------------------------------------------------------------------------------
- ---------------------------------------------------------------------------------------------------------------------------------
- ---------------------------------------------------------------------------------------------------------------------------------
- ---------------------------------------------------------------------------------------------------------------------------------
- ---------------------------------------------------------------------------------------------------------------------------------
- ---------------------------------------------------------------------------------------------------------------------------------
- ---------------------------------------------------------------------------------------------------------------------------------
- ---------------------------------------------------------------------------------------------------------------------------------
</TABLE>
16
<PAGE>
V. MATERIALS PRECAUTIONS
Fingerstick for testing of donor suitability will be performed in the
prep area. All disposable materials contacting HBsAg-reactive blood, plasma,
saliva and venipuncture area will be placed in biohazard bags and autoclaved
prior to final disposition, with the exception of the final container.
Non-disposable equipment used such as the refractometer, expressors and
centrifuge cups will be disinfected with 10% sodium hypochloride and
thoroughly cleaned. Absorbent paper will be placed under the donor's forearm
while donating and the chair will be cleaned with disinfectant following the
donation. Blood bags will be placed in protective plastic bags during
centrifugation. Testing samples will be clearly labeled as reactive for
hepatitis. Blood contamination or spillage will be disinfected with 10%
sodium hypochloride solution for 20 minutes. Final disposition of all
materials will be incinerated.
Samples from an HBsAg-positive donor will be labeled with a biohazard
sticker attached to each segment. Each segment will also be labeled with a
control number and a sticker stating that "This sample is known to be reactive
for Hepatitis B surface antigen".
VI. TESTING FACILITY
Abbott Laboratories has agreed to be the test facility for testing blood
or plasma samples for HBsAg-positive donors. Other FDA acceptable laboratory
facilities could be used in the future. A letter of agreement will be
obtained at that time and submitted to the FDA (See Exhibit F).
Additional testing will be done at the laboratory approved under the
present regular location license and/or at local laboratories, meeting
requirements and specifications of CFR640.71. An agreement to do testing with
any lab will be kept on file at the location and submitted to the FDA when
necessary.
17
<PAGE>
EXHIBIT F
[LETTERHEAD]
October 28, 1991
James B. Riter, Treasurer
American Plasma Management, Inc.
4764 South 9th East
Salt Lake City, UT 84117
Dear Mr. Riter:
Mr. David Lester has asked me to respond to your letter of Aug. 19, 1991,
regarding testing of plasma samples for hepatitis B surface antigen.
Please be advised that Abbott Laboratories holds both product and
establishment licenses from the Center for Biologics Evaluation and
Research, FDA, license number 43. Testing is conducted using FDA licensed
kits, in Abbott quality control facilities.
Samples are tested as part of the manufacturing process for IN VITRO assay
kits. The test protocols are incorporated into the Product License
Application for the kit, and are thus approved by the FDA when the product
license is issued.
Testing facilities are inspected by the FDA on an average of three times
per year; these inspections are allowed under drug and device regulations
and per the Federal Food, Drug and Cosmetic Act.
Please contact me directly if you have further questions.
Sincerely,
ABBOTT LABORATORIES
/s/ Marijane Sidote
Marijane Sidote
Director, ADD Regulatory Affairs
Responsible Head
18
<PAGE>
VII. PRODUCT LABELING
All HBsAg-positive plasma will be drawn for non-injectable and diagnostic
purposes only.
SOURCE PLASMA
CAUTION:
FOR USE IN MANUFACTURING NON-INJECTABLE PRODUCTS ONLY
Collected from a donor AMERICAN PLASMA
known to be Reactive for RENO, INC.
HBsAg. This plasma pre- 4764 South 900 East
sumed to be INFEC- Salt Lake City, UT 84117
TIOUS for HEPATITIS
1000 ml. Container License #839
Ship at Temperatures - 5 c or Colder.
Store at - 20 c or Colder.
-----------------------------------------------------
Prepared from whole blood collected in 4% Sodium
Citrate solution anticoagulant.
_____ 100 ml. _____ 120 ml.
PLASMA COLLECTED FROM:
A KNOWN HBsAg REACTIVE DONOR
________________________________ bleed number
volume _______________________________ mls.
______________________________ expiration date
-----------------------------------------------------
Negative by a test for antibody to HIV and HCV.
Negative by an FDA licensed test for anti-HBC.
19
<PAGE>
VII. PRODUCT LABELING
All HBsAg-positive plasma will be drawn for non-injectable and diagnostic
purposes only.
SOURCE PLASMA
CAUTION:
FOR USE IN MANUFACTURING NON-INJECTABLE PRODUCTS ONLY
Collected from a donor AMERICAN PLASMA
known to be Reactive for MANAGEMENT, INC.
HBsAg. This plasma pre- 4764 South 900 East
sumed to be INFEC- Salt Lake City, UT 84117
TIOUS for HEPATITIS
1000 ml. Container License #732
Ship at Temperatures - 5 c or Colder.
Store at - 20 c or Colder.
----------------------------------------------------
Prepared from whole blood collected in 4% Sodium
Citrate Solution anticoagulant.
_____ 100 ml. _____ 120 ml.
PLASMA COLLECTED FROM:
A KNOWN HBsAg REACTIVE DONOR
_________________________________ bleed number
volume __________________________________ mls.
__________________________________ expiration date
----------------------------------------------------
Negative by a test for antibody to HIV and HCV.
Negative by an FDA licensed test for anti-HBC.
19
<PAGE>
BIOHAZARD LABEL
[LOGO]
20
<PAGE>
VIII. STORAGE
HBsAg-reactive plasma will be stored as indicated by CFR 640.69.
IX. SHIPPING
Each bottle will be wrapped in absorbent packing material. Each wrapped
bottle will be placed in a plastic bag and then into the well of a biohazard
styrofoam shipping container, total volume per container not to exceed 4000
ml. The styrofoam box will be sealed top to bottom with tape, placed in a
corrugated box, and the corrugated box sealed securely. A biohazard label
will be applied to the outside of the corrugated box. Documentation of bleed
numbers, date of donation and quantity of each unit will be included with
each shipment.
Plasma bottles and samples will be shipped in accordance with 21 CFR
600.15, 606.40 (a) (7), 606.100 and 606.165.
American Plasma will follow all criteria necessary for shipping
HBsAg-positive units as directed by the United States Postal Service,
Department of Health and Human Services, Center for Disease Control and the
Department of Transportation.
X. RECORDS
Logs will be maintained to assist in the inspection of the following
areas: autoclave sterilization, storage temperature, whole blood log and
pre-issuance visual inspection. In addition, all records normally maintained
for non-HBsAg-reactive plasma procurement will be maintained for
HBsAg-reactive plasma, if applicable (i.e. the scale calibration log, etc).
21
<PAGE>
XI. INFORMED CONSENT
See Exhibit B Page #4
XII. STANDARD OPERATING PROCEDURES
The standard operating procedure presently in use at each facility will
be followed in its entirety with the exception of those modifications listed
herein.
Additionally, the laboratory testing requirements shall include those
stated in 21 CFR 640.63 plus:
a. serum protein electrophoresis initially and every two months;
continued donation with abnormal results requires the written
approval of the donor's personal physician or the center's Medical
Director.
b. for HBsAg-reactive or anti-HB core positive donors, ALT
measurements initially and every month. If ALT levels exceed two
times the upper limit of normal values, the donor must be deferred
until acceptable levels occur and a physician reinstates the donor.
c. except for known anti-HIV-1 and HIV-2 positive donors in special
programs, anti-HIV-1 and HIV-2 testing is performed in accordance
with 21 CFR 610.45.
XIII. DONOR PROCESSING FORM
See Exhibit G - Form FN-404.
Any donor who has taken Accutane will be deferred for six months
following the last dose taken.
Any donor who has taken Tegison will be deferred for three years
following the last dose taken.
22
<PAGE>
CENTER
------------------------------------------
DONOR NAME:
LAST FIRST MI
------------------- ------------ -----
DONOR NO. BLOOD GROUP
------------- ---------------
PROGRAM
------------------------------------------
- -------------------------------------------------
AFFIX BLEED LABEL HERE
- -------------------------------------------------
INSTRUMENT # | - DONOR INITIALS
|
- -------------------------------------------------
AFFIX BLEED LABEL HERE
- -------------------------------------------------
INSTRUMENT # | - DONOR INITIALS
|
- -------------------------------------------------
AFFIX BLEED LABEL HERE
- -------------------------------------------------
INSTRUMENT # | - DONOR INITIALS
|
- -------------------------------------------------
AFFIX BLEED LABEL HERE
- -------------------------------------------------
INSTRUMENT # | - DONOR INITIALS
|
- -------------------------------------------------
AFFIX BLEED LABEL HERE
- -------------------------------------------------
INSTRUMENT # | - DONOR INITIALS
|
- -------------------------------------------------
AFFIX BLEED LABEL HERE
- -------------------------------------------------
INSTRUMENT # | - DONOR INITIALS
|
- -------------------------------------------------
AFFIX BLEED LABEL HERE
- -------------------------------------------------
INSTRUMENT # | - DONOR INITIALS
|
<TABLE>
<CAPTION>
- ----------------------------------------------------------------------------------------------------------------------------------
DATE DAY OF WEEK (M,T,W,Th,F,S,Su)
- ----------------------------------------------------------------------------------------------------------------------------------
DONOR WEIGHT | INITIALS
- ----------------------------------------------------------------------------------------------------------------------------------
MEDICAL HISTORY QUESTIONS [ILLEGIBLE]
- ----------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C> <C>
|YES|NO| |YES|NO| |YES|NO| |YES|NO| |YES|NO| |YES|NO| |YES|NO|
-------- -------- -------- -------- -------- -------- --------
Q.1 Any [ILLEGIBLE] ? |___|__| |___|__| |___|__| |___|__| |___|__| |___|__| |___|__|
- ----------------------------------------------------------------------------------------------------------------------------------
Q.2 From [ILLEGIBLE] ? |___|__| |___|__| |___|__| |___|__| |___|__| |___|__| |___|__|
- ----------------------------------------------------------------------------------------------------------------------------------
Q.3 Weight loss of 10 lbs. or more during
past 9 months? |___|__| |___|__| |___|__| |___|__| |___|__| |___|__| |___|__|
- ----------------------------------------------------------------------------------------------------------------------------------
Q.1 [ILLEGIBLE] ? |___|__| |___|__| |___|__| |___|__| |___|__| |___|__| |___|__|
- ----------------------------------------------------------------------------------------------------------------------------------
Q.2 [ILLEGIBLE] ? |___|__| |___|__| |___|__| |___|__| |___|__| |___|__| |___|__|
- ----------------------------------------------------------------------------------------------------------------------------------
Q.3 [ILLEGIBLE] ?
|___|__| |___|__| |___|__| |___|__| |___|__| |___|__| |___|__|
- ----------------------------------------------------------------------------------------------------------------------------------
Q.4 Blood or heart [ILLEGIBLE] ? |___|__| |___|__| |___|__| |___|__| |___|__| |___|__| |___|__|
- ----------------------------------------------------------------------------------------------------------------------------------
Q.5 [ILLEGIBLE] ? |___|__| |___|__| |___|__| |___|__| |___|__| |___|__| |___|__|
- ----------------------------------------------------------------------------------------------------------------------------------
Q.6 [ILLEGIBLE] ? |___|__| |___|__| |___|__| |___|__| |___|__| |___|__| |___|__|
- ----------------------------------------------------------------------------------------------------------------------------------
Q.7 [ILLEGIBLE] ? |___|__| |___|__| |___|__| |___|__| |___|__| |___|__| |___|__|
- ----------------------------------------------------------------------------------------------------------------------------------
Q.8 Using any drugs, or under the influence |___|__| |___|__| |___|__| |___|__| |___|__| |___|__| |___|__|
of drugs or alcohol now?
- ----------------------------------------------------------------------------------------------------------------------------------
Q.9 [ILLEGIBLE] ? |___|__| |___|__| |___|__| |___|__| |___|__| |___|__| |___|__|
- ----------------------------------------------------------------------------------------------------------------------------------
Q.10 Lost red blood cells or donated whole |___|__| |___|__| |___|__| |___|__| |___|__| |___|__| |___|__|
blood in the past 8 weeks?
- ----------------------------------------------------------------------------------------------------------------------------------
Q.11 [ILLEGIBLE] ? |___|__| |___|__| |___|__| |___|__| |___|__| |___|__| |___|__|
- ----------------------------------------------------------------------------------------------------------------------------------
Q.12 [ILLEGIBLE] ? | |* | | |* | | |* | | |* | | |* | | |* | | | * |
--- -- --- -- --- -- --- -- --- -- --- -- --- --
- ----------------------------------------------------------------------------------------------------------------------------------
APPROX. DATE OF LAST BLOOD OR PLASMA
DONATION AT ANOTHER CENTER? (Enter [ILLEGIBLE])
INITIALS OF
INTERVIEWER
- ----------------------------------------------------------------------------------------------------------------------------------
VITAL SIGNS
- ----------------------------------------------------------------------------------------------------------------------------------
BLOOD PRESSURE (Units:[ILLEGIBLE]) |BY| | | | | | | | | | | | | | |
- ----------------------------------------------------------------------------------------------------------------------------------
PULSE (Units:[ILLEGIBLE]) |BY| | | | | | | | | | | | | | |
- ----------------------------------------------------------------------------------------------------------------------------------
TEMPERATURE (Units:[ILLEGIBLE]) |BY| | | | | | | | | | | | | | |
- ----------------------------------------------------------------------------------------------------------------------------------
HEMATOCRIT (Units:[ILLEGIBLE]) |BY| | | | | | | | | | | | | | |
- ----------------------------------------------------------------------------------------------------------------------------------
PLASMA PROTEIN (Units:[ILLEGIBLE]) |BY| | | | | | | | | | | | | | |
- ----------------------------------------------------------------------------------------------------------------------------------
DONATION AUTHORIZED BY | DONOR FEE | | | | | | | | | | | | | |
- ----------------------------------------------------------------------------------------------------------------------------------
PHLEBOTOMY BY | ARM USED (Circle) | |L / R| |L / R| |L / R| |L / R| |L / R|
- ----------------------------------------------------------------------------------------------------------------------------------
MONOGRAM | TECH INITIALS | | | | | | | | | | | | |
- ----------------------------------------------------------------------------------------------------------------------------------
DC BY | 4 MONTH SAMPLE |
| COLLECTED BY | | | | | | | | | | | | |
- ----------------------------------------------------------------------------------------------------------------------------------
POST DONATION CHART OC CHECK | | | | | | |
- ----------------------------------------------------------------------------------------------------------------------------------
</TABLE>
REMARKS:
REMARKS:
REMARKS:
REMARKS:
REMARKS:
REMARKS:
REMARKS:
23
<PAGE>
As part of the interrogation of an HBsAg-positive donor, the following form will
be used as an addendum to Form FN-404 (see attached) which replaces Form
F149-103.
-------------------------------------------------
Are you taking or have you ever taken
human pituitary-derived growth hormone?
Yes___No___Init. of Question___Date____
(If so, donor must be permanently
deferred.)
-------------------------------------------------
24
<PAGE>
To Whom It May Concern:
I have agreed to act as personal physician for _____________________ with
regard for plasmapheresis as he does not have his own physician.
In addition to monthly physical exams to determine suitability for continued
donations, reviewing lab results and recertification, I will also determine the
collection volume and frequency of donation.
Sincerely,
Kent Hebdon, M.D.
I understand that Dr. Hebdon is acting as my personal physician ONLY as it
pertains to plasmapheresis. I will keep him informed of visits to other
physicians that should become necessary due to any non-related incidents.
Donor Signature:
Date:
25
<PAGE>
I have reviewed and understand the information provided to me regarding the
spread of the AIDS virus by donated blood or plasma; and if I consider myself to
be a person at risk for spreading the virus known to cause AIDS, I agree not to
donate blood or plasma for transfusion to another person or for further
manufacture.
DONOR'S SIGNATURE_________________________________ DATE________________
26
<PAGE>
HBsAg-POSITIVE DONOR PROCESSING CHECK LIST
<TABLE>
<CAPTION>
- ----------------------------------------------------------------------------------------------------------------------------
A. B. C. D. E. F. G. H. I. J. K. L.
Floor/
Recep Recep Recep Floor Floor Destroy/ Dest
Area Area Area Area Area Label Label Decon Log Mgmt
Date Bleed # Gear Isolate Waste Decon Spill Waste Decon Samples Unit Gear Entry review
- ----------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C> <C> <C> <C> <C> <C> <C> <C>
- ----------------------------------------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------------------------------------
</TABLE>
Description of tasks A through L:
A. Gear: Protective gear worn (i.e. disposable gown, face mask, goggles,
gloves).
B. Isolate: Isolated customer in time and/or space.
C. Recep Area Waste: Packaged capillary tube, cottonballs, thermometer
sheath and lancet for destruction.
D. Recep Area Decon: Surfaces wiped down and decontaminated with 1:10 bleach
& water, centrifuge & refractometer with 1:100 bleach & water.
E. Floor/Recep Area Spill: Immediately wiped up spill and decontaminated
affected surface or area with 1:10 bleach and water. "N/A" if no spill
occurred.
F. Floor Area Waste: Packaged prep material, used softgoods and tape for
destruction.
G. Floor Area Decon: Surfaces wiped down and decontaminated with 1:10 bleach
& water. Auto-C machine cleaned and decontaminated per manufacturer's
instructions.
H. Label Samples: Samples labeled with bleed number and biohazard stickers.
I. Label Unit: Unit labeled with bleed number and biohazard stickers.
J. Destroy/Decon Gear: Protective gown, facemask, gloves packaged for
destruction. Hemostats and strippers disinfected with 1:10 bleach &
water.
K. Dest Log Entry: Notation made in destruction log that all used disposable
items have been packaged for destruction.
L. Mgmt Review: Procedures reviewed and confirmed by facility management.
27
<PAGE>
Schedule 6.1
Excluded Employees
Mr. Daniel Idema
