EXHIBIT A
AGREEMENT FOR THE PURCHASE OF PLASMA
This Purchase and Sale Agreement is made on November 1, 1996, between SeraCare,
Inc., having an address at 0000 Xxxxxxx Xxxx Xxxx, Xxxxx 0000, Xxx Xxxxxxx,
Xxxxxxxxxx 00000 ("SELLER") and NABI, having an address at 0000 Xxxx xx
Xxxxxxxx Xxxxxxxxx, X.X., Xxxx Xxxxx, Xxxxxxx 00000 ("NABI").
ARTICLE 1. RECITALS
This Agreement is made on the basis of the following facts:
1.1 The term "Plasma" as used in this Agreement shall refer to citrated
human blood plasma to be delivered from plasmapheresis bleedings
conducted at SELLER's Plasma Donor Center locations, all of which
Plasma shall comply with the specifications and testing requirements
attached hereto as Exhibit A (the "Specifications"). NABI may amend
the Specifications at any time or from time to time on ten (10) days'
prior written notice to SELLER.
ARTICLE 2. TERMS OF SALE
2.1 Agreement to Purchase and Sell
Subject to the terms and conditions of this Agreement, NABI agrees to
purchase and SELLER agrees to sell Plasma collected by SELLER at the
following Plasma Donor Center location (hereinafter referred to as the
("Center"):
Clearfield, Utah
Raleigh, North Carolina
Macon, Georgia
2.2 Quantity of Plasma Purchased
During the term of this Agreement, SELLER agrees to sell to NABI
SELLER's entire production of Plasma from the Center, and NABI agrees
to purchase SELLER's entire production of Plasma from the Center.
2.3 Price
The price for the Plasma to be purchased from SELLER by NABI shall be:
(a) SOURCE PLASMA. For the period February 1, 1997 through
December 31, 1997, the price for Source Plasma shall be $50.00 per
liter. For the period January 1, 1998 through December 31, 1998, the
price for Source Plasma shall be $50.00 per liter increased or
decreased by a percentage exactly equal to the percentage by which the
weighted average sales price (exclusive of transportation charges,
additional testing fees, charges to comply with governmental or
industry requirements and taxes, duties or other governmental charges)
("Weighted Average Sales Price") charged by NABI to its contract
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customers for Source Plasma for the period ended December 31, 1997 has
increased or decreased over the Weighted Average Sales Price charged
by NABI to its contract customers for Source Plasma for the twelve
months ended December 31, 1996. For each twelve-month period
thereafter, the price for Source Plasma shall be the price for the
immediately prior twelve-month increased or decreased by a percentage
exactly equal to the percentage by which the Weighted Average Sales
Price charged by NABI to its contract customers for Source Plasma for
the immediately prior twelve-month period has increased or decreased
over the Weighted Average Sales Price charged by NABI for Source
Plasma for the second prior twelve month period.
For the period January 1, 1999 through January 31, 2000, the price for
Source Plasma shall be the contract price per liter on December 31,
1998, increased or decreased by a percentage exactly equal to the
percentage by which the weighted average sales price (exclusive of
transportation charges, additional testing fees, charges to comply
with governmental or industry requirements and taxes, duties or other
governmental charges) ("Weighted Average Sales Price") charged by NABI
to its contract customers for Source Plasma for the period ended
December 31, 1998 has increased or decreased over the Weighted Average
Sales Price charged by NABI to its contract customers for Source
Plasma for the twelve months ended December 31, 1997. For each
twelve-month period thereafter, the price for Source Plasma shall be
the price for the immediately prior twelve-month increased or
decreased by a percentage exactly equal to the percentage by which the
Weighted Average Sales Price charged by NABI to its contract customers
for Source Plasma for the immediately prior twelve-month period has
increased or decreased over the Weighted Average Sales Price charged
by NABI for Source Plasma for the second prior twelve month period.
(b) SPECIALTY PLASMA. NABI may, at its sole option and
discretion, require that SELLER collect Specialty Plasma at the Center
and sell such Specialty Plasma to NABI, at a price mutually agreed
upon for each Specialty Plasma. The price shall be no less than the
price paid for Tetanus Plasma. The Tetanus price shall be $54.00 per
liter. The CMV price shall be $54.00 per liter. The prices for
Specialty Plasma including Tetanus and CMV will be adjusted for the
period January 1, 1998 through December 31, 1998 and the period
January 1, 1999 through January 31, 2000 utilizing the same basis for
adjustment as reflected in (a) above.
2.3.1 Until such time as SELLER is registered as a drug manufacturer under
Section 510 of the Federal Food, Drug and Cosmetic Act and has a valid
establishment license and a valid product license for source plasma
issued under Section 351 of the U.S. Public Health Service Act ("FDA
Licensure"), or for a period of 12 months from the effective date of
this Agreement, whichever occurs first, NABI shall pay to SELLER as an
advance against purchase price for Plasma to be purchased by NABI
hereunder the sum of $50.00 for each liter of Source Plasma collected
by SELLER during the period. Such advance payments shall be credited
against the purchase price for the first liters of Plasma shipped by
SELLER to NABI following FDA Licensure and, to the extent not so
credited,
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shall become immediately due and payable upon termination of this
Agreement for any reason whatsoever or to the extent otherwise
provided in this Agreement. SELLER's obligation to repay such advance
payments shall be secured pursuant to the Security Agreement of even
date herewith between SELLER and NABI (the "Security Agreement").
2.4 Payments
NABI shall pay all amounts due SELLER with respect to Plasma shipped
by SELLER to NABI within 10 days of shipment. SELLER shall not
invoice NABI for Plasma prior to shipment of such Plasma. Payments for
plasma prior to FDA Licensure shall be made within ten days of draw.
NABI shall designate the carrier for shipment of Plasma. NABI agrees
to bear all costs of shipment, freight, insurance and all governmental
taxes and duties incurred during shipping from the Center to the
receiving terminal designated by NABI.
Title to Plasma shall transfer to NABI upon delivery of the Plasma to
the carrier designated by NABI.
2.5 Production
During the term hereof, SELLER agrees to provide NABI each month in
writing rolling twelve-month forecasts of its projected production of
Plasma from the Center and agrees to send NABI prompt written notice
of anticipated production variations from such forecasts.
2.6 Term of Agreement
This Agreement shall commence on February 1, 1997 and shall continue
until January 31, 2000. By written notice given to SELLER no later
than September 30, 1999, NABI may extend the term of the Agreement for
a period of three additional years, in which event all of the
provisions of this Agreement shall continue in effect including the
pricing adjustment provisions which shall be calculated each January 1
and shall utilize the approach specified in 2.3 above with the
comparative periods rolling forward as appropriate.
ARTICLE 3. GENERAL PROVISIONS
3.1 Representations and Warranties
SELLER represents and warrants that:
3.1.1 All Plasma shipped to NABI hereunder shall comply with the
Specifications.
3.1.2 All Plasma sold to NABI hereunder, as of the date of shipment, shall
not be adulterated or misbranded within the meaning of the Federal
Food, Drug and Cosmetic Act, shall be in full compliance with the
Biological Products Section of
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the Pubic Health Service Act and applicable regulations thereunder,
and shall be in full compliance with any other applicable federal,
state, or local laws, ordinances or regulations and all requirements
to be QPP certified. In the event that SELLER shall ship to NABI any
Plasma which is not in compliance with said laws, regulations or the
Specifications, SELLER shall be responsible for all reasonable losses
or damages to NABI.
3.1.3 SELLER shall use its best efforts to obtain FDA Licensure and QPP
certification as soon as practicable.
3.1.4 Once obtained, SELLER shall maintain FDA Licensure for the term of
this Agreement. No Plasma shall be shipped hereunder until such
license is obtained or if said FDA Licensure for any reason becomes
invalid, suspended or revoked.
3.1.5 SELLER shall, within thirty (30) days of its receipt of any of the
following, provide NABI a copy of any list or Observations (Form
FD483), Notice of Adverse Findings, Information Letter, Regulatory
Letter, or the like issued to SELLER by the U.S. Food and Drug
Administration ("FDA") or other similar federal, state or local
regulatory authority. SELLER shall also provide NABI a copy of its
written response to the issuing agency.
3.1.6 SELLER shall notify NABI in writing, of any change or replacement of
the Responsible Head or Manager at any Center. Said notification
shall, with respect to replacements, include the qualification of such
individual(s). Failure to so notify NABI will subject this Agreement
to immediate cancellation.
3.2 Defective Plasma
All Plasma furnished by SELLER which does not conform to the
Specifications and conditions set forth herein or is otherwise
defective shall be subject to rejection notwithstanding prior payment
by NABI. SELLER shall reimburse any and all reasonable costs and
expenses, including but not limited to, transportation, storage,
handling and pooling costs incurred by NABI with respect to any such
defective Plasma. SELLER shall bear any and all costs and expenses of
returning or disposing of any such defective Plasma. SELLER shall have
the right to instruct NABI to destroy such defective Plasma in lieu of
returning it to SELLER. In the event SELLER does not give directions
regarding the disposition of such rejected Plasma within fifteen (15)
business days after the giving of written notice of rejection by NABI
to SELLER, NABI shall have the right to destroy or otherwise dispose
of all such rejected Plasma at SELLER's expense without any liability
whatsoever to SELLER and without any obligation to compensate SELLER
for any part of said rejected Plasma.
In the event NABI makes prior payment for Plasma which is later
rejected, the purchase price of such rejected Plasma, and any other
costs and expenses incurred by NABI in connection with such rejected
Plasma, may be set off or deducted from any other payments due to
SELLER from NABI. In addition, NABI shall have the right, at its sole
election, to demand reimbursement, in cash, for
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the purchase price and any other sums paid in connection with any such
rejected Plasma.
3.3 Inspections
SELLER agrees to permit NABI and any authorized representative of the
Public Health Service, the FDA and any state and local governmental
agencies to conduct periodic inspections of the Center and to review
all records kept by SELLER regarding the collection, storage,
processing and shipping of Plasma. SELLER further agrees to permit
NABI, industry certification groups and any customer of NABI
authorized by NABI to conduct similar periodic inspections of the
Center. NABI, at its sole option and expense, shall have the right to
make and retain copies of all such records kept by SELLER. In
addition, SELLER shall provide NABI with copies of all correspondence
between SELLER and any governmental entity regarding any such
inspections or records.
3.4 Donor Testing Results
NABI agrees at its sole cost and expense to arrange testing for each
donor as required by Title 21 of the Code of Federal Regulations and
furnish test results of all such tests to SELLER. SELLER agrees at its
sole cost and expense to deliver and/or mail samples on a daily basis
to a laboratory to be designated by NABI.
3.5 Unsatisfactory Report
In the event any Center receives an unsatisfactory inspection report
or rating from NABI, the FDA or any other federal or local regulatory
agency or industry certification group, NABI may, at its sole option,
refuse to accept Plasma from such Center until the unsatisfactory
condition is corrected.
ARTICLE 4. MATERIALS FURNISHED TO SELLER
4.1 NABI agrees to provide at no cost to SELLER pheresis machines
sufficient in order for SELLER to meet its requirements hereunder.
SELLER shall provide at its expense all maintenance and service to
maintain such machines in good working order, reasonable wear and tear
excepted. SELLER agrees to utilize the pheresis machines at the rate
required by the pheresis machine manufacturer and further agrees to
compensate NABI for any penalties incurred by NABI as a result of
under utilization by SELLER of the pheresis machines.
4.2 NABI agrees to provide at no cost to SELLER with the following items
in quantities sufficient to maintain an inventory adequate to meet the
normal operating requirements of the Center. Inventory replenishment
will be based on one soft goods set-up per donor plasmapheresed.
Additionally, NABI agrees that in the event it exercises its option to
require SELLER to collect Specialty Plasma at the Center, NABI shall
supply to SELLER at no cost to SELLER such soft goods as are set forth
in Subsection 4.2.1(a) through (e) below in such quantities as may be
necessary for the collection of
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such Plasma. In addition, NABI shall supply at no cost to SELLER
other supplies as necessary in such quantities as are necessary for
SELLER to collect Specialty Plasma for sale to NABI.
4.2.1 Soft goods and other materials needed for plasmapheresis:
(a) Plastic disposables for plasma collection.
(b) Fistula needle.
(c) Anticoagulant.
(d) Final pooling container, bag or bottle.
(e) Normal saline solution (if requested by NABI).
4.2.2 Final pooling container labels with bleed numbers.
4.2.3 Product packaging and test report forms.
4.2.4 Shipping labels.
4.2.5 Plasma shipping forms.
4.2.6 All tests required by the Specifications.
4.2.7 Copy of NABI's S.O.P. and letter of authorization from NABI to the FDA
permitting the use of said S.O.P. at each Center.
4.3 Inventories
Within five (5) days after SELLER's receipt of any of the materials
and supplies listed above, SELLER agrees to provide NABI with signed
receipts, packing slips and such other documentation as NABI may
reasonably request as proof of delivery to and receipt by SELLER of
such materials and supplies.
In addition, SELLER agrees to submit to NABI on a monthly basis a
written inventory of all materials and supplies provided to SELLER by
NABI, including detailed information regarding the exact location,
disposition and use of said materials and supplies. NABI shall have
the right, but not the obligation, to inspect this inventory of
materials and supplies, without notice, throughout the term and at the
end of this Agreement.
SELLER agrees to pay for, and NABI shall not be obligated to provide,
any materials or supplies which are used by SELLER in amounts
exceeding two and one-half percent (2-1/2%) over one (1) set-up per
donor for the production of the Plasma actually shipped to NABI during
any consecutive three (3) month period throughout the term of this
Agreement. In the event SELLER fails to account, to NABI's
satisfaction, for the disposition and use of the above-listed
materials and supplies furnished by NABI, NABI shall have the right,
in addition to any other rights and remedies it may have hereunder or
at law or in equity, to either
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demand cash reimbursement or to set off or deduct from any payments
owed to SELLER from NABI the amount of Thirteen Dollars ($13.00) per
soft goods set-up not properly accounted for. This amount may be
adjusted from time to time based on increased costs due to changes in
the composition and/or pricing per soft goods set-up.
4.4 Ownership
SELLER agrees that all machines, material and supplies furnished to
SELLER by NABI in connection with this Agreement shall remain the sole
property of NABI during the term of this Agreement and shall be
returned to NABI at SELLER's sole cost and expense at the conclusion
of the term of this Agreement or within twenty (20) days after receipt
of notice of termination of this Agreement by NABI. SELLER shall
maintain at its expense such insurance on such equipment, machines and
supplies as NABI shall request.
ARTICLE 5. MISCELLANEOUS PROVISIONS
5.1 Relationship of the Parties
The relationship between NABI and SELLER is, and during the term
hereof shall be, that of buyer and seller. SELLER is in no way a
partner, legal representative or agent of NABI for any purpose
whatsoever and has no right or authority to incur, assume or create,
in writing or otherwise, any warranty, liability or obligation of any
kind, expressed or implied, in the name of, or on behalf of NABI.
5.2 Right of First Refusal.
If during the term of this Agreement or within three months thereafter
SELLER decides to sell one or more Center, or any portion of one or
more Center, to a non affiliated third party, whether such sale shall
be by merger, consolidation, sale of assets or stock, or otherwise,
and including a sale of Center by reason of a sale of SELLER, NABI
shall have the right of first refusal to purchase such Center or
portions thereof. SELLER shall notify NABI in writing of the terms of
any bona fide offer which it has received (including the name of the
prospective purchaser and its affiliates), and NABI shall have a
period of 45 days from the date of such notice to terminate to notify
SELLER of NABI's intention to purchase under the same (or economically
equivalent) terms and conditions.
If NABI declines to purchase any or all of the Center or any portion
thereof under its right of first refusal, SELLER may not sell such
Center or portion hereof unless prior to consummation of such sale,
the purchaser delivers to NABI its unconditional agreement to assume
this Agreement and to fully, faithfully and punctually discharge
SELLER's obligations hereunder.
In the event a Center or any portion thereof is sold, whether to NABI
or to a third party, all advance payments for plasma not previously
credited to NABI shall become immediately due and payable.
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5.3 Insurance and Indemnification
SELLER hereby agrees to indemnify and hold NABI and its affiliates,
agents, employees and directors harmless from any and all claims,
losses, liabilities, damages, adverse publicity, attorneys' fees,
costs and expenses which may be sustained by and/or claimed against
NABI by virtue of the negligent or intentionally harmful performance
of services rendered by SELLER, by breach by SELLER of any terms and
conditions of this Agreement, by virtue of the defective or negligent
preparation of Plasma or Plasma products sold by SELLER to NABI, or by
virtue of any accident, event, condition or occurrences which may take
place or originate at any Center.
During the term of this Agreement and for a period of one year
thereafter, Seller shall maintain product liability insurance with
respect to all plasma sold hereunder in an amount not less than five
hundred thousand dollars ($500,000). Such insurance shall name NABI
as an additional insured and shall provide that such insurance shall
not be canceled except upon ten (10) days prior written notice to
NABI.
5.4 Termination and Breach
Upon the occurrence of any of the following events, either party shall
be entitled: (i) to receive immediate written notice of the occurrence
of such event by the other party; and (ii) to terminate this Agreement
immediately by giving written notice of termination to the other
party;
5.4.1 In the event of insolvency of the other party or in the event that an
involuntary or voluntary petition in bankruptcy is filed by, against,
or on behalf of the other party; or
5.4.2 In the event the other party makes a general assignment for the
benefit of its creditors, or a receiver or trustee is appointed for
its business or property; or
5.4.3 In the event of an unscheduled closure of the Center for any purpose
for any period of time exceeding thirty (30) days.
5.4.4 In the event FDA Licensure and QPP certification is not obtained
within eighteen (18) months from the date hereof or, once obtained,
ceases or is suspended.
5.4.5 In the event the other party shall fail to perform or fulfill any of
its obligations hereunder, or shall fail to observe the terms and
conditions hereof and such failure shall continue to exist for thirty
(30) days after written notice of such failure has been given to that
party. Sections 5.4.3 and 5.4.4 are applicable on a single center
basis.
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Failure or delay by NABI or SELLER following any breach of this
Agreement shall not constitute a waiver of NABI's or SELLER's right to
terminate this Agreement by reason of such occurrence or breach or by
reason of the subsequent occurrence of any other event or breach.
5.5 Force Majeure
Neither party shall be liable for non-performance caused by factors
beyond that party's direct control, said factors including but not
being limited to:
(a) Natural disasters or other "Acts of God";
(b) Riots, wars, or insurrections; and
(c) Actions of any governmental agency, including rules, laws,
orders, regulations and restrictions.
5.6 Purchase Orders
All sales of Plasma by SELLER to NABI hereunder shall be subject to
the provisions of this Agreement and shall not be subject to the terms
and conditions contained in any purchase order of NABI or confirmation
of SELLER except insofar as any such purchase order or confirmation
establishes the quantity or mix of Plasma ordered or sold thereunder
and the delivery date and carrier thereof.
5.7 Termination
No termination of this Agreement shall affect or impair in any respect
any right or obligation of either party arising prior to the effective
date of such termination.
5.8 Arbitration
NABI and SELLER agree that any disputes or claims arising under or in
connection with this Agreement, including the interpretation or
application of this Agreement, shall be settled by arbitration in
accordance with the rules of the American Arbitration Association then
in force. If the parties cannot agree upon a single arbitrator within
ten (10) days after demand by either of them for arbitration. then
each party shall select one arbitrator from a list of arbitrators
supplied by the American Arbitration Association. The two arbitrators
so selected shall then choose a third arbitrator in order that the
dispute may be finally resolved by a majority of the panel of three
arbitrators so selected. The decision of the arbitrator or arbitrators
shall be final and binding upon the parties both as to law and fact.
The expenses of the arbitration shall be shared equally by the
parties, unless the arbitration award stated that the expense shall be
otherwise assessed. Any such arbitration shall take place in Boca
Raton, Florida.
5.9 Miscellaneous
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This Agreement shall be binding on and inure to the benefit of the
respective parties hereto and their successors and permitted assigns.
This Agreement may not be assigned by SELLER without NABI's prior
written consent. This Agreement may be executed simultaneously in
counterparts, each of which shall be deemed an original, but all of
which together shall constitute one and the same instrument. This
Agreement and the Security Agreement represent the entire
understanding of the parties hereto with respect to the subject matter
hereof, and supersedes any and all other prior agreements between the
parties. The terms and provisions of this Agreement cannot be
terminated or modified or amended except in writing and signed by the
party against whom enforcement is sought. This Agreement shall be
construed and enforced in accordance with the laws of the State of
Florida without regard to conflicts of laws principles, and any suit,
action or proceeding arising out of or relating to this Agreement may
be commenced and maintained in any court of competent subject-matter
jurisdiction in Broward County, Florida, and each party waives
objection to such jurisdiction and venue. The provisions of this
Agreement are severable and any invalidity, unenforceability or
illegality in any provision or provisions hereof shall not affect the
remaining provisions of this Agreement. In any suit, action or
proceeding arising out of or in connection with this Agreement, the
prevailing party shall be entitled to an award of the amount of
reasonable attorney's fees and disbursements actually billed to such
party in connection therewith, including fees and disbursements on one
or more appeals. All notices required or allowed hereunder shall be in
writing and shall be deemed given upon (i) hand delivery or (ii) three
days after deposit of the same in the United States certified mail,
return receipt requested, first-class postage and registration fees
prepaid and correctly addressed to the party for whom intended at
their address written in the first paragraph hereof (Attention:
President), or such other address as is most recently noticed for such
party as aforesaid. All references to gender or number in this
Agreement shall be deemed interchangeably to have masculine, feminine,
neuter, singular or plural meaning, as the sense of the context
requires.
6.0 Authority to Execute
SELLER hereby represents and warrants that it is not a party to, nor
is it bound by any agreement which precludes or otherwise restricts
the performance of its obligations hereunder. SELLER further
represents and warrants that it has the right, legal capacity and
authority to enter into this Agreement and that the execution of the
Agreement has been duly authorized.
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement on the dates
set forth below.
NABI SERACARE, INC.
By /S/ By /S/
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Xxxx X. Xxxxxxxx Xxxxx X. Xxxxx
Executive Vice President President
Chief Operating Officer Chief Executive Officer
DATE: 1/3/97 DATE: 12/4/97
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