Exhibit 10.13
PLASMA SUPPLY AGREEMENT
THIS PLASMA SUPPLY AGREEMENT (this "Agreement"), effective January 3, 2006
is made by Omrix Biopharmaceutical, Ltd., an Israeli company, with its
principal place of business located at MDA Blood Center, Tel Xxxxxxxx Xxxxxxxx,
Xxx Xxxx 00000 Xxxxxx ("BUYER") and the DCI Management Group, LLC, a limited
liability company affiliated with Xxxxxx Medical Services, LLC, having its
principal office at 0000 Xxxx Xxxxxxx Xxxx, Xxxxx 000, Xxxxxxxxx, XX 00000
("SUPPLIER") (collectively the "parties").
SUPPLIER agrees to sell and BUYER agrees to purchase Recovered Plasma for
Fractionation and Frozen Recovered Plasma for Fractionation from SUPPLIER as
described in Exhibit B, which is attached hereto and, incorporated herein by
reference.
For purposes of this Agreement, "Frozen Recovered Plasma for Fractionation"
means recovered human plasma that has been frozen within 24 hours after
phlebotomy, and "Recovered Plasma for Fractionation" means recovered human
plasma that has been frozen within 72 hours after phlebotomy (collectively,
"Recovered Plasma"). During the Term (defined below) of this Agreement and for a
period of two years thereafter, BUYER shall not directly or indirectly purchase
any Recovered Plasma from any of the community blood banks, and/or hospitals
(collectively, "CBBs") set forth in Exhibit A attached hereto and made a part
hereof. This purchase restriction will cover any additional CBBs that, upon
agreement of the parties, are added to Exhibit A. This purchase restriction
shall not apply if SUPPLIER provides less than 50% of the Committed Volume, and
BUYER terminates this Agreement due to such material breach of SUPPLIER.
1. PRICES AND VOLUMES - 2006
SUPPLIER agrees to supply BUYER a minimum of *** liters of Recovered
Plasma from December 1, 2005 through December 31, 2006 and in each of the
four calendar years thereafter, ending December 31, 2010. However, SUPPLIER
will make its best efforts to maximize the supply up to *** liters of
Recovered Plasma per calendar year during the Term.
The following is the agreed to price level for 2006. This would include
Recovered Plasma that is collected from September 1, 2005 and stored until
December 2005. This Recovered Plasma will be billed in the year 2005 and
applied against the 2006 volumes, and will be delivered to BUYER no later
than March 31, 2006.
The price for DECEMBER 1, 2005 - DECEMBER 31, 2006 will be as follows:
The first *** liters will be priced as follows:
Frozen Recovered Plasma for Fractionation *** per liter
Recovered Plasma for Fractionation *** per liter
PORTIONS OF THIS EXHIBIT MARKED BY AN *** HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
2
For all volumes over the initial *** liters will be priced as follows:
Frozen Recovered Plasma for Fractionation *** per liter
Recovered Plasma for Fractionation *** per liter
All prices are FOB CBB locations.
SUPPLIER will notify BUYER in writing by no later than January 31, 2006 of
the volume of Recovered Plasma (with a deviation of +/- 10%) that SUPPLIER
commits to provide BUYER during 2006 (including December 2005). For each
subsequent calendar year during the Term, SUPPLIER will notify BUYER in
writing no later than November 15 of the prior year of the committed volume
for such subsequent calendar year. The volumes referred in this paragraph
are referred to as the "Committed Volumes."
BUYER shall not be obligated to purchase more than *** liters per year.
If an annual Committed Volume is less than *** liters, SUPPLIER shall
continue during such year to make best efforts to provide *** liters,
and BUYER shall be obligated upon written notice from SUPPLIER to purchase
such additional volume, unless prior to receipt of any such notice BUYER
notifies SUPPLIER in writing that BUYER does not, during such year, want to
be obligated to purchase more than the Committed Volume, which notice shall
be provided by BUYER no later than 90 days from SUPPLIER's notice setting
forth the Committed Volume. Notwithstanding the foregoing, BUYER shall not
be required to purchase more than the Committed Volume of the prior
calendar year plus *** (not to exceed *** liters), provided, BUYER
notifies SUPPLIER in writing 90 days before the American Association of
Blood Banks (AABB) annual meeting that BUYER only intends to purchase a
Committed Volume equal to that of the prior calendar year plus ***.
In order to assist BUYER to qualify the Recovered Plasma for Thrombin,
SUPPLIER will, within 30 days of the date of this Agreement, provide BUYER
from each CBB with (i) 10 Recovered Plasma units which were separated and
frozen after exactly 24 hours (i.e., Frozen Recovered Plasma for
Fractionation) and (ii) 10 Recovered Plasma units which were separated and
frozen after exactly 72 hours (i.e., Recovered Plasma for Fractionation).
BUYER will pay for such units in accordance with the above pricing.
Pricing for 2007 THROUGH 2010
SUPPLIER will notify BUYER in writing (the "Price Notice") of the prices
for Recovered Plasma applicable to the subsequent calendar year by no later
than November 15th of each year preceding the applicable calendar year.
SUPPLIER will keep BUYER updated on a regular basis on the status of price
the negotiations between SUPPLIER and the CBBs. SUPPLIER will not raise
prices to BUYER above the CPI (i.e., U.S. Consumer Price Index-All Urban
Consumers, U.S. City Average, as published by the Bureau of Labor
Statistics,
3
U.S. Department of Labor) without BUYER's written consent. The prices set
forth in a Price Notice for a calendar year will be based on current market
conditions. If the current market price is above the CPI adjusted price,
then the parties will mutually agree on the price to be charged. If there
is a disagreement about the price determined by SUPPLIER based upon current
market conditions, the parties will follow Section 14, Disputes, and the
price determined under Section 14, Disputes, will apply retroactively to
all purchases made by BUYER of the Committed Volume for such year. If at
anytime, a requirement of a regulatory agency (e.g., IGIV specification for
Omrigam) results in BUYER not being able to use a certain variety of
Recovered Plasma (i.e., Frozen Recovered Plasma for Fractionation or
Recovered Plasma for Fractionation) to produce and distribute BUYER's
products, then, upon written notice to SUPPLIER, BUYER shall no longer be
required to purchase such Recovered Plasma from SUPPLIER.
Orders for Recovered Plasma may be submitted by BUYER or BUYER's
affiliates.
2. TERM
The term of this Agreement will be begin on December 1, 2005 and end
December 31, 2010, unless terminated sooner as provided under this
Agreement (the "Term"). At the end of the Term, the contract can be
extended with the mutual agreement of the parties for 3 years.
3. PAYMENT
Net 30 days from date of invoice, which may be issued any time after
shipment. All payments will be wire transferred to a mutually agreed
account. Late payment would be charged interest at 12% per annum or 1% per
month.
SUPPLIER shall invoice BUYER and BUYER shall remit payment via wire
transfer to:
DCI Management Group, LLC
Wachovia Bank - NA
000 Xxxxxxxxxx Xxx.,
Xxxxx Xxxxxx, Xxx Xxxx, 00000
ABA #000000000,
Account #2000011693161.
Wherever there is provision in this Agreement for a credit to BUYER, if
such credit cannot be fully applied to invoices within 60 days of when the
credit arises, then such credit, or remaining balance, shall be paid by
SUPPLIER to BUYER at the end of such 60-day period.
4
4. SPECIFICATIONS
The CBBs will follow specifications as per attached Omrix specifications
(see Exhibit B attached) and all Applicable Laws (collectively,
"Specifications").
Any exceptions to the Specifications must be mutually agreed to in advance
and in writing. Unless otherwise agreed in writing by the parties, CBBs
will follow all F.D.A. 'lookback' (lookback) and post-donation
requirements. BUYER will supply exact address to send lookback
notifications and the parties will mutually agree to procedures covering
all lookback events, which procedures will include a full credit to BUYER
for any Recovered Plasma (i) that did not meet Specifications at the time
of collection; (ii) where there was a subsequently identified testing issue
after collection; or (iii) the unit was recalled by the CBB. All CBBs have
received all necessary regulatory approvals and permits under "Applicable
Law," including, but not limited to, F.D.A. approval, required state
licensing, and Clinical Laboratory Inspection Act (CLIA) licensure and
approval. SUPPLIER agrees to work with the CBBs to make reasonable efforts
to assist BUYER to comply with requirements of the Israeli Ministry of
Health relating to the import of the Recovered Plasma into Israel. CBBs
will be required to sign the BUYER's Short Supply Agreement, attached
hereto as Exhibit C, which form may be changed by BUYER from time to time.
The CCBs can collect Recovered Plasma before the actual Short Supply
Agreement date (but not earlier than September 1, 2005) as long as they
certify that the Specifications were being followed on the date of the
earliest bleed. As used herein, "Applicable Law" shall mean all applicable
federal, state and local laws, rules, regulations and requirements of
governmental and regulatory authorities, including, but not limited to, the
FDA investigational new drug (IND) guidelines, Title 21 of the U.S. Code of
Federal Regulations Part 640, as amended, cGMP (defined in Exhibit B), the
Clinical Laboratory Inspection Act (CLIA) and such other applicable laws,
regulations, requirements, and guidelines.
5. TRANSPORTATION
BUYER will supply shipping boxes for Recovered Plasma and will be
responsible for their distribution to the CBBs. Desired size would allow
16-20 units per box. If required, SUPPLIER can purchase these boxes and
charge BUYER the cost of purchasing and transporting the boxes to the CBBs.
Unless otherwise agreed in writing, shipments will be accompanied by
documentation as required by the FDA, Specifications and Applicable Law,
and as may otherwise be specified by BUYER. The shipping boxes shall bear
external labeling which correlate to the donation list. Each bag of
Recovered Plasma in a shipping box shall bear, in addition to other
required labels, a bar code label of the donation number.
The parties will agree on a shipping schedule that will allow all CBBs to
ship every 2-4 weeks depending on size of the CBB and freezer capacity at
the CBB.
5
SUPPLIER will provide BUYER each month with a rolling three month forecast
of the anticipated shipping schedule (total by month and type)).
BUYER assumes title to the Recovered Plasma when it is accepted on BUYER's
behalf by BUYER's designated carrier. All transportation charges are for
BUYER's account.
If a shipment of any Recovered Plasma or any portion thereof fails to
conform to the Specifications or is otherwise not as warranted, then BUYER
shall have the right to reject such non-conforming shipment or portion
thereof. BUYER shall give written notice to SUPPLIER of its rejection
hereunder, setting forth in detail the basis of the rejection, within
forty-five (45) days after receipt at BUYER's facility, specifying the
grounds for such rejection. The nonconforming shipment or portion thereof
shall be held for SUPPLIER's disposition, or shall be returned to SUPPLIER,
or destroyed if required by Applicable Law, in each case at SUPPLIER's
expense, as directed by SUPPLIER. BUYER shall not be obligated to buy or
pay for any shipment which does not comply with the Specifications, or is
otherwise not as warranted. BUYER shall receive a full credit for any
rejected shipment, which shall include BUYER's shipping costs to BUYER's
facility. Upon a request from BUYER, any CBB that is the source of a
non-conforming shipments shall be removed from Exhibit A.
6. PRODUCT
As used herein, "Recovered Plasma" shall mean "Plasma for Further
Manufacturing" (Frozen Recovered Plasma and Recovered Plasma for further
manufacturing) as defined by the regulations of the Food and Drug
Administration (Title 21 Code of Federal Regulation 606.3 et. seq.), the
American Association of Blood Banks manual, and the Specifications set
forth in Exhibit B, now or hereafter in effect, and shall have been
collected from volunteer homologous donors and processed pursuant to the
Applicable Laws.
All Recovered Plasma shall be certified by the CBBs to be in compliance
with the Specifications, including, without limitation, having been tested
for viral markers/NAT-PCR, as listed in Exhibit B. This Agreement is
subject to CBB compliance with any and all test requirements currently and
hereafter mandated by Applicable Law.
SUPPLIER warrants and covenants that all Recovered Plasma delivered under
this Agreement meets the Specifications contained in Exhibit B. BUYER
assumes full responsibility for the storage, handling, processing,
manufacturing, sale and use of the Recovered Plasma upon SUPPLIER's
delivery to BUYER.
BUYER shall only be responsible for any loss, destruction or damage to the
Recovered Plasma at all times that such Recovered Plasma is in the care,
custody and control of BUYER (including its agents and contractors).
6
Notwithstanding any other agreements, each party agrees to hold harmless
and indemnify the other party (including its affiliates, and each of their
respective directors, officers, agents, and employees) against, and
reimburse the indemnitees for, any and all claims, demands, actions, causes
of action, losses, judgments, damages, costs and expenses (including
reasonable attorney's fees) arising out of any claim against an indemnitee
(i) in respect to bodily injury, death, and property damage to the extent
arising from the acts or omissions of the indemnifying party, (ii) a
party's violation of any Applicable Law; or (iii) any breach by a party of
any of its representations, warranties, covenants or agreements in this
Agreement. At the indemnified party's option, the indemnifying party shall
also defend the indemnified party, and in such case, shall have sole
control of the defense and settlement, provided that any settlement must be
agreed to by the indemnified party.
This obligation to indemnify is conditional upon the party seeking to be
indemnified providing the other party with prompt written notice of any
claim or action for which the first party seeks to be indemnified. Each
party agrees to cooperate in providing information necessary to defend
against any such legal liability.
Each party agrees to maintain general and professional liability insurance,
each in the amount of at least One Million dollars ($1,000,000) combined
single limit, and to provide copies to the other party of certificates of
such insurance upon request.
BUYER and SUPPLIER, on their own behalf, acknowledge and agree that each
shall inform the other of any third party claim related to this Agreement
and involving the other party as soon as it becomes aware of such claim.
7. OTHER
All notices, communications, demands, and payments required or permitted to
be given or made hereunder or pursuant hereto shall conclusively be
presumed for all purposes of this Agreement to be given or made by
certified mail or overnight courier service, addressed as follows:
BUYER: Omrix Biopharmaceuticals, Ltd
MDA Xxxxx Xxxxxx, Xxx Xxxxxxxx
Xxxxxxxx, Xxx Xxxx 00000 Israel
Attn: Xxxxxx Xxxx
President and CEO
SUPPLIER: DCI Management Group, LLC
0000 Xx. Xxxxxxx Xxxx
0
Xxxxx 000
Xxxxxxxxx, XX 00000
Attn: Ira London
Vice President of Marketing
Each party will appoint a contact person to handle all logistics and quality
issues.
8. GOVERNING LAW
Without giving effect to the conflict of law provisions, this Agreement
will be governed and construed in accordance with the laws of the State of
New York.
9. TERMINATION FOR DEFAULT
Either party may terminate this Agreement by written notice to the other
party if such other party materially fails to perform or materially
defaults in any manner in the performance of this Agreement in accordance
with its terms, and fails to cure any such breach after receiving a "Show
Cause Notice" identifying the failure, and providing thirty (30) days to
cure the failure or nonperformance. However, if the claimed failure to
perform or other default is the subject of a bona fide dispute between the
parties, then the parties agree to refer the dispute to the informal
dispute escalation process under Section 14 of this Agreement and that the
30-day cure period shall be waived pending the outcome of that process.
BUYER may terminate this Agreement upon written notice if a regulatory
action or decree prevents BUYER from performing the manufacture and/or
distribution of the end products (i.e., Omrigam NF) derived from the
Recovered Plasma. In the event of a termination, the parties agree to cease
all further purchases. The BUYER's liability to SUPPLIER in the event of
termination will continue only with respect to goods and/or services
received and accepted within thirty (30) days after the effective date of
termination.
Neither party will be liable for failure to perform due to unforeseeable
causes beyond such party's control and without such party's fault or
negligence, such as acts or omissions by the other party, fires, floods,
epidemics, quarantine restrictions, strikes, freight embargoes, war, an act
of governmental or quasi-governmental authorities, restrictions of law or
of a court of competent jurisdiction.
The rights and remedies of either party provided in this paragraph are not
exclusive and are in addition to any other rights and remedies provided by
law or under this Agreement.
8
10. INDEPENDENT CONTRACTOR
SUPPLIER is furnishing its services hereunder as an independent contractor,
and nothing herein will create any association, partnership or joint
venture between the parties hereto, or any employer-employee relationship.
11. CONFIDENTIALITY
Each party may designate any or all information, data, written and/or
verbal communications developed, accessed, provided, or referenced during
the performance of this Agreement as Confidential.
The BUYER and SUPPLIER acknowledge and agree that if during the Term of
this Agreement such information is designated confidential and is disclosed
by one party to the other, each party will hold all such confidential
information in the strictest confidence as a fiduciary and will not
voluntarily sell, transfer, publish, disclose, display or otherwise make
available to any third persons such confidential information or any portion
thereof without the express written consent of the other party or use such
information except in the performance of this Agreement. The BUYER and
SUPPLIER will each use their best efforts to protect the confidentiality of
all such information consistent with the manner in which they protect their
most confidential business information.
For the purposes of the Agreement, confidential information includes all
Agreement terms and conditions, and such other information identified as
Confidential prior to disclosure. Notwithstanding the foregoing, (i) a
party may disclose the terms of this Agreement to securities and other
regulatory agencies as may be advised by legal counsel, (ii) to affiliates,
attorneys, accountants and consultants, or to any potential investor or
acquirer, provided all are bound by confidentiality obligations, and (iii)
BUYER may disclose this Agreement to a purchaser of the products produced
by BUYER from the Recovered Plasma.
12. TITLE TO GOODS
SUPPLIER warrants and represents that clear and unrestricted title for all
goods or products under this Agreement will pass to the BUYER upon
acceptance by BUYER as defined in Section 5; however, BUYER's
responsibilities for all goods and products provided hereunder arise with
BUYER's taking possession of such goods and products.
13. SOLE AGREEMENT/AMENDMENTS
This Agreement constitutes the entire agreement between the parties hereto
concerning the subject matter contained in it, and no amendment,
modification or
9
waiver of any of the terms and conditions hereof will be valid unless in
writing and executed by both parties. Any prior verbal or written
agreements are not considered a part of this Agreement.
14. DISPUTES
To the extent that there are disputes with respect to performance,
including payments, under this Agreement, such disputes are not cause for
the SUPPLIER to stop work or BUYER to stop payment under the Agreement, but
will be resolved in due course to the extent possible in accordance with
this section.
The parties to this Agreement will attempt to resolve any problem or
dispute arising out of, or related to, this Agreement through good faith
consultation in the ordinary course of business. In the event that any
problem or dispute is not so resolved, either party may upon written notice
("Notice") to the other request that the matter be referred to senior
management officers within each respective organization with express
authority to resolve the problem or issue but who are not immediately
responsible for the matters contemplated by this Agreement. Within ten days
of the Notice of the dispute, such representatives will meet or confer at
least once in good faith to negotiate a resolution.
If the representatives are unable to resolve the problem or dispute within
thirty (30) days of the Notice, either party may take the matter to the
Dispute Resolution Procedure set forth below.
Dispute Resolution Procedure: If any problem or dispute arising out of or
related to this Agreement is not resolved by the parties in the above
described manner, at the request of either party, the matter will be
submitted to binding arbitration conducted in New York City, by a sole
arbitrator in the English language, and in accordance with the rules and
procedures set forth by American Arbitration Association. The sole
arbitrator shall be appointed by agreement of the parties. In the event the
parties fail to agree upon the appointment of the sole arbitrator within
thirty (30) days after a notice of arbitration is given by either party to
the other, then the arbitrator shall be selected and appointed by the
American Arbitration Association. The arbitration award and/or
determination shall be final and binding and judgment may be entered
thereon in any court of competent jurisdiction.
15. ORDER OF PRECEDENCE
In the event of a conflict between the terms of this Agreement, or any
amendments hereto executed in accordance with Section 13, the terms of the
amendment govern.
10
16. SEVERABILITY
Each paragraph and provision of this Agreement is severable from the entire
Agreement, and if any provision is declared invalid, the remaining
provisions will remain in effect.
17. WARRANTIES
Each party hereby represents, warrants and covenants that:
(a) All services performed and products supplied under this Agreement will
conform to the requirements of this Agreement, the Specification, and all
Applicable Laws.
(b) It is duly organized, validly existing and in good standing under the
laws of the jurisdiction in which it was organized, (b) this Agreement,
when executed and delivered by it, will be the legal, valid and binding
obligation of it, enforceable against it in accordance with its terms, (c)
the execution, delivery and performance of this Agreement by it do not and
will not (i) conflict with, or constitute a breach or default under, its
charter documents or any material agreement, contract, commitment, or
instrument to which it is a party or (ii) require the consent, approval or
authorization of, or notice, declaration, filing or registration with, any
third party or any governmental or regulatory authority, and (d) it has not
previously granted and will not grant any rights to any third party which
are, nor contract with any third party in any manner which is, inconsistent
with the rights granted herein.
18. BANKRUPTCY
This Agreement may be terminated by either party upon serving notice in the
event that the other party shall be or become insolvent, shall cease doing
business as a going concern, make an assignment for the benefit of its
creditors, admit in writing its inability to pay its debts as and when they
fall due or in the event that there are any proceedings instituted by or
against it in bankruptcy or under the insolvency laws or for receivership
or dissolution which are not frivolous or vexatious proceedings or not
dismissed within thirty (30) days from commencement of such proceedings.
19. ASSIGNMENT
This Agreement shall not be assignable by any party without the prior
written consent of the other party, except that (i) either party shall be
permitted to assign this Agreement, without the other party's consent, to
an affiliate or a company acquiring all or substantially all of the first
party's assets, voting stock or business to which this Agreement relates,
and (ii) BUYER shall be permitted to assign this
11
Agreement, all upon written notice to the other party. Such assignment
shall be subject to the assignee agreeing in writing to assume the benefits
and obligations of this Agreement. Any assignment made without prior
written consent, if such consent is required, shall be wholly void and
invalid.
20. RECORDS
SUPPLIER shall maintain complete and accurate records of and supporting
documentation for supply of the Recovered Plasma to BUYER, for a period of
two (2) years following termination of this Agreement, or other longer
period required under this Agreement or Applicable Laws. SUPPLIER agrees to
provide BUYER with documentation and other information as may be reasonably
requested by BUYER to verify accuracy and compliance with the provisions of
this Agreement.
21. SURVIVAL
Any provisions of this Agreement that, in order to fulfill the purposes of
such provisions, need to survive the termination or expiration of this
Agreement, shall be deemed to survive for as long as necessary to fulfill
such purposes.
IN WITNESS WHEREOF, the parties hereto caused this Agreement to be executed
by their representatives duly authorized as of the day and year first above
written.
DCI MANAGEMENT GROUP, LLC OMRIX BIOPHARMACEUTICALS, LTD
/s/ Xxx London /s/ Xxxxxx Xxxx
------------------------------------- ----------------------------------------
Xxx London Xxxxxx Xxxx
Vice President of Marketing President and CEO
Date: Date:
------------------------------- ----------------------------------
12
EXHIBIT A - COMMUNITY BLOOD BANKS SUPPLYING PLASMA TO BUYER
EXHIBIT A
COMMUNITY BLOOD BANKS SUPPLYING PLASMA TO BUYER
1. LIFESOUTH, GAINESVILLE, FL
2. BLOODNET, LAKELAND, FL
3. MEDIC, KNOXVILLE, TN
4. ANMED, ANDERSON, SC
5. DAK-MINN, GRAND FORKS, ND
6. SIOUX VALLEY, SIOUX FALLS, SD
7. LANE, EUGENE, OR
8. NWFL, PENSACOLA, FL
9. XXXXXXXX, XXXXXXX, GA
10. PIEDMONT, SPARTANBURG, SC
11. SOUTH TEXAS BLOOD AND TISSUE CENTER, SAN ANTONIO, TX
12. CHAMPLAIN, PLATTSBURGH, NY
13. USBB, MIAMI, FL
14. BLOOD ASSURANCE, CHATTANOOGA, TN
15. BC NC WISCONSIN, WAUSAU, WI
16. SUNCOAST COMMUNITIES BLOOD BANK, SARASOTA, FL
17. BLOOD BANK OF SAN BERNARDINO AND RIVERSIDE COUNTIES, SAN BERNARDINO, CA
18. COMMUNITY BLOOD BANK, RANCHO MIRAGE, CA
19. UNIVERSITY OF TEXAS MD XXXXXXXX CANCER CENTER, HOUSTON, TX
This is a preliminary listing of CBBs. Additional CBBs will be added as
necessary to increase yearly volumes, upon the mutual written agreement of the
parties. Such additions, upon mutual written agreement, may be made by SUPPLIER
at any time during the Term of this Agreement.
13
SUPPLIER shall provide BUYER access to all documents relating to its and the
CBBs' performance under this Agreement to the extent required by Applicable Law
or for BUYER to comply with Applicable Law. SUPPLIER shall allow and arrange
access by BUYER during normal business hours to all such documents and to its
and the CBBs' facilities for purposes of inspections or other requests for
access by BUYER in accordance with Applicable Law, and to confirm compliance
with the terms of this Agreement. Inspections by BUYER will be made upon
reasonable prior notice. The inspection rights in this Exhibit shall be
authorized in SUPPLIER's agreements with the CBBs. Any CBB that is found not to
conform to Applicable Law or the Specifications shall be removed from this
Exhibit A.
If any CBB is closed as a result of regulatory sanctions or receives a warning
letter or consent decree from the FDA or any other governing entity or if
SUPPLIER or such CBB is found to have compliance problems that might affect the
quality of the Recovered Plasma (each a "Triggering Event"), SUPPLIER must
notify BUYER immediately, and in any event not later than 5 business days after
SUPPLIER learns of such Triggering Event, consent decree or problem. Following
any such Triggering Event, based on the substance of the Triggering Event
(related to the quality of the plasma) SUPPLIER will recall all stocks of
Recovered Plasma held by BUYER at such time and issue a credit to buyer.
Additionally, if any CBB is found by BUYER to be deficient in its compliance
with the Specifications or Applicable Law, SUPPLIER will have thirty (30)
business days to provide, in writing, a corrective action plan ("CAP")
acceptable to BUYER. No Recovered Plasma will be shipped to BUYER from such CBB
until the CAP was successfully implemented and such CBB was approved by BUYER to
be clear of the deficiency declared as provided above. If the CAP is
unacceptable to BUYER or if a CAP cannot be implemented for any CBB within
ninety (90) days after the announcement of such a deficiency, then, at BUYER's
option, this Agreement, including the Recovered Plasma volumes, can be modified
to eliminate such CBB.
14
EXHIBIT B - OMRIX PRODUCT SPECIFICATIONS
HUMAN PLASMA FOR FRACTIONATION
RECOVERED PLASMA SPECIFICATIONS AND REQUIREMENTS
DEFINITION:
As used herein, "Plasma" shall mean "Plasma for Further Manufacturing" (Frozen
Recovered Plasma and Recovered Plasma for further manufacturing) as defined by
the regulations of the Food and Drug Administration (Title 21 Code of Federal
Regulation 606.3 et. seq.), the American Association of Blood Banks manual, and
the applicable items set forth in this Exhibit B now or hereafter in effect, and
shall have been collected from volunteer homologous donors and processed
pursuant to the regulations applicable thereto.
Frozen Recovered Plasma for Fractionation; i.e. separated from the cellular
elements and frozen by cooling rapidly to minus 20 degrees C (-20 degrees C)
within 24h or Recovered Plasma for Fractionation separated from the cellular
elements and frozen by cooling rapidly to minus 20 degrees C (-20 degrees C)
within 72h.
The plasma may contain cryoprecipitate fraction or be cryo-depleted.
The plasma meeting these definitions will comply with all requirements as they
may be updated from time to time by the FDA regulations.
All blood donations are collected by FDA licensed blood donor centers or blood
banks.
Anticoagulant solutions, plasma containers and labels must comply with the CFR
regulations.
DONOR SELECTION, BLOOD COLLECTION AND RECORD MAINTENANCE
Authorizations of the blood donor centers/ blood banks as well as procedures of
selection of donors and blood collections are according to the regulations and
guidelines of the FDA/CFR.
STORAGE AND SHIPMENT
The plasma is maintained at or below -20 degrees C during storage and
transportation according to CFR regulations. Documentation of temperature
monitoring is required during shipping.
The Plasma received by Omrix must be less than 12 months from the date of
donation.
15
VIRAL MARKER & NAT-PCR TESTS
Each donation must be individually tested and found non-reactive/ negative for:
HBsAg
antibodies to HCV and HIV 1/2.
HTLV I/II
All donors are tested for indirect Antiglobulin and have been found negative.
All units are tested and found negative for Syphilis.
PCR/NAT tests for HCV and HIV will be performed by FDA approved mini pool
testing (pools of 16 or 24 according to manufacturers approved methodology) and
found negative. Units found to be positive shall be removed from the shipment.
Additional PCR/NAT (e.g. Parvao B19) testing will be performed if required by
FDA--if FDA requires additional PCR/NAT testing CBB will take necessary action
to meet FDA standards.
All the tests must be performed in FDA approved laboratories.
Supplier shall provide Buyer with a copy of the directional insert for each type
of test kit used in testing and a notification of changes of test kit types.
The kit details should be provided including Name, Manufacturer, Generation and
License Number.
All testing kits used for plasma donation testing must be licensed by the US
FDA. Each test kit must be validated in the testing lab and a report provided.
This shall be interpreted to mean, the Blood Centers supplying Recovered Plasma
Products to Omrix will use licensed FDA test kits and will follow test kit
manufacturers directional insert for testing procedure, including use of
controls. The Blood Center testing lab will employ the use of external controls
and participate in proficiency testing programs for those related viral markers
as available. The testing lab has not validated the test kit, the FDA licenses
the test kit and to our understanding releases each lot from licensed
manufacturer, (i.e. Xxxxxx/ Ortho) prior to release of lot numbers for Blood
Bank usage. Any changes to the testing laboratory and test kits used for the
plasma testing must be notified in writing to Buyer at least 60 days prior to
the shipment of any plasma using such changed test kits. Documentation on the
test kits validation must be provided.
GENERAL QA AND RA REQUIREMENTS
- Short Supply Agreement must be signed between each blood center
(Exhibit D) and Buyer.
16
- Plasma Master File should be submitted once and then when versions are
updated or new versions are issued.
- Supplier must receive written approval prior to shipment to Buyer
after execution of the Short Supply Agreement.
- Description of the separation process after phlebotomy until storage.
- Traceability to the individual plasma units will be kept on file for
not less than 15 years. This information will be made available to
Buyer upon request.
- Buyer will have the right to inspect/audit relevant areas of the CBB
facilities and the relevant documentation associated with the supply
of plasma once a year. This rate may be adjusted whenever considered
necessary.
- Look back procedures according to the current FDA guidelines is
established and followed and Buyer's QA will be notified of any Look
back action as required in the regulations.
- All preventive measures are taken to reduce the possible risk of
transmission of Creutzfeldt - Jacob disease (CJD) and variant
Creutzfeldt - Jacob disease (vCJD) in blood and blood products.
- All preventive measures are taken to reduce the possible risk of West
Nile virus transmission and SARS in blood.
- Implementation of additional viral marker tests in the future if
required by FDA authorities.
- Supplier will give Buyer the required regulatory support for
submission to regulatory authorities for so long as this Agreement is
in effect.
- Supplier will provide Buyer with the regulatory support services set
forth hereto
a) In the event Buyer notifies Supplier of a recall, product
withdrawal, or field correction of any aspect of Buyer's
product, whether or not effected voluntarily or requested or
ordered by any federal or state agency or government agency,
Supplier shall fully cooperate with Buyer as necessary to
support any investigation such as recall, withdrawal or
correction.
b) In the event Supplier believes that a recall, product
withdrawal, or field correction is necessary or otherwise
appropriate, Supplier shall promptly notify and consult with
Buyer, and Supplier shall cooperate as reasonably necessary
to effectuate any such recall, withdrawal or correction.
c) Provision of regulatory documentation or letter of access to
approved files to support Buyer in obtaining new
authorizations, such as Marketing Authorizations or Clinical
Trial Authorizations for Buyer's product worldwide.
d) Preparation of Short Supply Agreement
17
e) Response to questions from regulatory authorities worldwide
in relation to Marketing Authorization Applications or
requests for Clinical Trial Authorizations for Buyer's
product worldwide.
f) Provision of regulatory information to support
variations/supplements to existing Marketing Authorizations
for Buyer's product upon reasonable request from Buyer,
fully cooperate with and provide all assistance requested by
Buyer to obtain and maintain all regulatory approvals that
are required to manufacture, distribute, use or sell Buyer's
product. Supplier shall also assist Buyer in responding to
requests and inquiries from applicable regulatory
authorities prior to, during and after regulatory review
periods, including without limitation, providing all data,
records and reports requested by Buyer relevant to such
review periods.
The documentation should state the quality of plasma; i.e. Frozen Recovered
Plasma for Fractionation (within 24h) or Recovered Plasma for Fractionation
(within 72h).
Required Documentation for approval of the donor center/blood bank:
Plasma Master File for each donor center/blood bank which should include at
least the following information:
- Establishment License
- Epidemiological data
- Donor Exclusion Criteria
- Laboratory System Information
- Maintain SOPs: (Buyer can review and audit)
- Donor Record System
- Look back procedure
- Test Results Management
- Certificate of Quality (See Shipment Cover Sheet: Annex 1 to this
Exhibit B)
- Bleeding List
Additional information might be requested by the Israeli Ministry of Health
Each time the Plasma Master File is being updated a copy is to be provided to
Buyer.
Documentation provided:
A list of the names, address, and license number and/or Establishment
Registration Number of all CBBs included in the shipment, and the period of
collection for the plasma in the shipment, indicating the earliest and latest
donation date.
18
1. A complete bleeding list indicating the name and address of the donor
center, identification number of donation to be found on the plasma unit,
collection date, confirmation of negative test results for each test
required above, and donation volume.
A signed and approved Certificate of Quality which includes the following
information:
a. Customer name
b. Plasma Type
c. Shipment date
d. Delivery Number
e. Volume
f. Number of Bleeds
g. Number of Cases
h. Tests/Test Kit Name/Manufacturer/License/Results (viral markers
and NAT-PCR) and certify that specifications were met.
i. Statements required:
Plasma was collected and separated according to supplier
approval procedures.
Plasma quality is that required for production of plasma
derivative products intended for human use in USA.
Plasma has been collected in FDA licensed facilities under
CGMP guidelines and in accordance with the code of Federal
regulations CFR 21. Bleeding lists will be signed by the QA
responsible person
Plasma was collected and separated according to Supplier
approval procedures.
Statement regarding freezing and storage conditions
2. Documentation indicating information such as name of the product, the
quantity in liters, and the number of containers in the shipment, and other
standard requirements.
3. Documentation to be provided with the shipment
a. Certificate of Quality
b. A copy of the bleeding lists in each carton for the individual
units of plasma contained in that carton and a detailed
description of the CBB from where the plasma has been collected
from the approved list of CBBs as appears in Exhibit A.
4. Electronic file: In addition, Blood Centers will establish an electronic
file packing list similar to the Exhibit D (shipped 5-50-2003.csv) within 6
days after contract signature
QUALITY CONTROL BY CUSTOMER:
Units are removed and rejected if:
19
- They cannot be identified or have improper documentation.
- They have no date or incorrect date.
- They are pink or red colored or exhibit signs of hemolysis or
signs of excessive lipemia (based on visual test).
- They are broken.
- The unit does not appear in the bleeding list (surplus
bag/container).
- They are under filled (<100ml).
- There is Lookback information on a particular unit.
- The unit is positive for a viral marker/NAT test.
- The label content of the unit is not correspondent to the data
reported on the shipping list.
- Anti-D Reclassification plasma.
If significant in quantity, these rejected units will be deducted from future
invoices of the supplier.
20
ANNEX 1 TO EXHIBIT B
SHIPMENT COVER SHEET AND LETTER OF TESTING
CERTIFICATION FOR RECOVERED PLASMA FROZEN
(FROZEN WITHIN 24HOURS) SHIPPED AT -20 degrees OR COLDER.
Blood Center Name: _____________________________________________________________
Address: _______________________________________________________________________
City, State, Zip: ______________________________________________________________
F.D.A. License #: ______________________________________________________________
Telephone: _____________________________________________________________________
Fax: ___________________________________________________________________________
TO: OMRIX BIOPHARMACEUTICALS LTD.
Tel-Hashomer XXX 000
Xxxxxx-Xxx 00000, Xxxxxx
Date of shipment: ______________________________________________________________
Xxxx of Lading #: __________________________ Reference Number: _________________
Number of Cartons: ____________ (Carton numbers: From ____________ to _________)
The shipment contains _______________ plasma units,and liters of plasma.
All donations are from bleed date ________ to bleed date ________
FDA
Screening Test Test Kit Name Generation Manufacturer License #
-------------- ------------- ---------- ------------ ---------
HBsAg
anti-HIV 1 and 2
anti-HCV
HCV by NAT
HIV by NAT
Anti-Syphilis
21
HTLV I/II
Plasma bag (type, manufacturer): _______________________________________________
Anticoagulant: _________________________________________________________________
It is certified that all units in this shipment are tested and found
non-reactive for HIV-1 RNA, HCV RNA, HBsAg, HTLV I/II and for antibodies to HIV
1/2 and HCV with FDA licensed tests above. In addition, all units have tested
negative in the serological test for syphilis (STS) listed above.
Signature of Responsible Person
------------------------------------------------
Date
----------------------
22
SHIPMENT COVER SHEET AND LETTER OF TESTING
CERTIFICATION FOR RECOVERED PLASMA FROZEN
(FROZEN WITHIN 72 HOURS) SHIPPED AT -20 degrees OR COLDER.
Blood Center Name: _____________________________________________________________
Address: _______________________________________________________________________
City, State, Zip: ______________________________________________________________
F.D.A. License #: ______________________________________________________________
Telephone: _____________________________________________________________________
Fax: ___________________________________________________________________________
TO: OMRIX BIOPHARMACEUTICALS LTD.
Tel-Hashomer XXX 000
Xxxxxx-Xxx 00000, Xxxxxx
Date of shipment: ______________________________________________________________
Xxxx of Lading #: ____________________ Reference Number: _______________________
Number of Cartons: ___________ (Carton numbers: From ___________ to ___________)
The shipment contains _________ plasma units, and liters of plasma.
All donations are from bleed date _____________ to bleed date _____________
FDA
Screening Test Test Kit Name Generation Manufacturer License #
-------------- ------------- ---------- ------------ ---------
HBsAg
anti-HIV 1 and 2
anti-HCV
HCV by NAT
HIV by NAT
Anti-Syphilis
HTLV I/II
23
Plasma bag (type, manufacturer): _______________________________________________
Anticoagulant: _________________________________________________________________
It is certified that all units in this shipment are tested and found
non-reactive for HIV-1 RNA, HCV RNA, HBsAg, HTLV I/II and for antibodies to HIV
1/2 and HCV with FDA licensed tests above. In addition, all units have tested
negative in the serological test for syphilis (STS) listed above.
Signature of Responsible Person
------------------------------------------------
Date
------------------------
24
EXHIBIT C - SHORT SUPPLY AGREEMENT
SHORT SUPPLY AGREEMENT
As a supplier of Recovered Human Plasma to OMRIX BIOPHARMACEUTICALS, LTD.,
hereinafter "OMRIX", for use in the manufacture of licensed plasma products for
injection, the undersigned agrees to:
1. Comply with all applicable laws, rules, regulations, and guidelines,
including those of the U.S. Food and Drug Administration, which are
referenced in the Short Supply provisions of 21 CFR 601.22 and latest
version of OMRIX Recovered Plasma Specifications and Requirements.
2. Permit inspection of your facility, procedures, and records by OMRIX
personnel, the Food and Drug Administration, and other applicable
regulatory bodies.
3. Establish procedures, inspections, tests, or other arrangements
necessary to assure full compliance with all applicable regulations,
including continued physical control and accountability of Recovered
Human Plasma until shipment to OMRIX. Upon request, furnish OMRIX with
a copy of such procedures, inspections, tests, or other arrangements,
and advise OMRIX of any changes which could affect the continued
safety, purity, and potency of the Recovered Human plasma collected
for OMRIX.
4. This Short Supply Agreement covers all blood bank locations which are
represented by the undersigned and have the same FDA License number.
NAME OF
ESTABLISHMENT: ____________________________________________________________
ADDRESS: ____________________________________________________________
CITY, STATE, ZIP: ____________________________________________________________
FDA LICENSE NUMBER: ____________________________________________________________
AGREED TO BY:
------------------------------------------------------------
(Signature, Authorized Official)
------------------------------------------------------------
(Printed name and position)
DATE:
------------------------------------------------------------
25
FOR OMRIX BIOPHARMACEUTICALS, LTD.:
AGREED TO BY:
------------------------------------------------------------
(Signature, Authorized Official)
------------------------------------------------------------
(Printed name and position)
DATE:
---------------------------
26
EXHIBIT D - ELECTRONIC FILE
Northwest Florida Inc.
Blood Center
0000 X. 0xx Xxxxxx Xxxxxxxxx XX 00000
Shipping Date: 5/5/2003
Product Type: Frozen Recovered Plasma
Number of Records: 720
Quantity in Liters: 186.509
(Start Data)
BOXNUMBER UNITNUM COLLECTED VOLUME
--------- ------- --------- ------
3890 4340694 4/18/2003 0.24
3890 4340697 4/18/2003 0.26
3890 4340705 4/19/2003 0.282
3890 4340708 4/19/2003 0.209
3890 4507247 4/18/2003 0.27
3890 4507258 4/18/2003 0.245
3890 4562487 4/17/2003 0.22
3890 4562488 4/17/2003 0.287
3890 4619921 4/18/2003 0.301
3890 4661220 4/18/2003 0.237
