EXHIBIT 10.13
AMENDED AND RESTATED SUPPLY, MANUFACTURING, AND
DISTRIBUTION COLLABORATION AGREEMENT
This AMENDED AND RESTATED SUPPLY, MANUFACTURING AND DISTRIBUTION
COLLABORATION AGREEMENT (this "Agreement") is entered into as of the 1st day of
October, 1998 , by and between V.I. TECHNOLOGIES, INC., a Delaware corporation,
with its headquarters at 000 Xxxxxx Xxxx, Xxxxxxxx, Xxx Xxxx 00000 ("VITEX") and
the AMERICAN NATIONAL RED CROSS, a corporation formed under the laws of the
United States, with its headquarters at 0000 Xxxxxxxxx Xxxx, Xxxxx Xxxxxx,
Xxxxxxxx 00000 (the "ANRC").
W I T N E S S E T H:
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WHEREAS, VITEX is the owner/and or licensee of certain Proprietary Rights
(as hereinafter defined) with respect to the Product (as hereinafter defined);
and
WHEREAS, the ANRC has certain expertise in the promotion, distribution,
marketing and sale of products similar to the Product; and
WHEREAS, VITEX has certain expertise in the processing and manufacturing of
products similar to the Product; and
WHEREAS, the parties have entered into a Collaboration Agreement dated
February 22, 1991 between VITEX and the ANRC as First Amended and Restated in an
agreement dated July 22, 1996 (collectively the "First Collaboration
Agreement"); and
WHEREAS, as a result of the First Collaboration Agreement, each of the
parties has invested significant funds and other resources toward development of
the Product; and
WHEREAS, the mission of the ANRC is to fulfill the needs of the American
people for the safest, most reliable and most cost-effective blood, plasma and
tissue services through voluntary donations; and
WHEREAS, the ANRC and VITEX entered into the Supply, Manufacturing and
Distribution Collaboration Agreement the 15th day of December 1997 (the "Initial
Agreement"); and
WHEREAS, the ANRC desired to enter into the Initial Agreement so as to
materially enhance the safety of the Input (as hereinafter defined) to aid and
assist in advancing the health and well-being of as many people as possible and
thereby furthering the charitable mission of the ANRC; and
WHEREAS, the ANRC's distribution system is well-suited for professional
distribution of the Product; and
WHEREAS, in furtherance of the First Collaboration Agreement and the
parties' desire to extend their collaboration, VITEX desire that the ANRC
should be principally responsible for the promotion, marketing, sale and
distribution of the Product in the Territory (as hereinafter defined) and the
ANRC is prepared to accept such responsibility, all in accordance with the terms
and conditions of the Initial Agreement; and
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WHEREAS, the First Collaboration Agreement was amended and restated
contemporaneously with the Initial Agreement (the "Amended First Collaboration
Agreement"); and
WHEREAS, after nearly a year of experience of operating under the Initial
Agreement, the ANRC and VITEX wish to amend and restate the Initial Agreement;
and
WHEREAS, VITEX and the ANRC are committed to continue the foregoing
relationship that will ensure the greatest success for the Product (as
hereinafter defined) by ensuring its broad distribution and availability; and
WHEREAS, the parties hereby amend and restate the Initial Agreement as set
forth in this Agreement and desire to amend and restate the Amended First
Collaboration Agreement at the same time, such amended and restated agreement
being referred to as the Amended Restated First Collaboration Agreement.
NOW, THEREFORE, in consideration of the promises and the mutual covenants
and agreements contained herein, VITEX and the ANRC hereby agree as follows:
SECTION 1
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DEFINITIONS
When used in this Agreement, the terms set forth in this Section shall have
the following meanings:
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["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
1.1 "Affiliate" shall mean, with respect to each Party, any entity
directly or indirectly controlled by, controlling, or under common control with
such Party. For purposes of this definition, the meaning of word "control"
(including the terms "controlled by" and "under common control with") as used
with respect to any entity, means possession, direct or indirect, of the power
to direct or cause the direction of the management and policies of a Person
whether through ownership or vesting securities, contracts or otherwise. A
Person shall be deemed to control another Person if such Person owns fifty
percent (50%) or more of the voting securities of such other Person.
1.2 "Annual Report" shall have the meaning set forth in Schedule 5.8.
1.3 "Average Selling Price" shall have the meaning set forth in Section
5.1(a).
1.4 "Base Price" shall mean *** during Period One and Period Two and
during any Subsequent Period *** as adjusted as set forth in Section 5.1(c).
1.5 "Base Sale Price" shall mean **** during Period One, *** during Period
Two and during any Subsequent Period ****, as such price during the Subsequent
Period is adjusted as provided in Section 5.1(c).
1.6 "Competitive Product" shall mean human blood plasma intended for
transfusion which has been demonstrated
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*************************************************************** as compared to
the Product, and has received final FDA approval for the same indications for
which the Product is then currently used.
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1.7 "Confidential Information" shall have the meaning set forth in Section
9.4
1.8 "CPI" shall mean the Consumer Price Index (U.S. City Average) which
became effective in January 1978 as compiled by the Bureau of Labor Statistics,
United States Department of Labor.
1.9 "Distribution Rights" shall have the meaning set forth in Section 2.1.
1.10 "Effective Date" shall mean December 15, 1997.
1.11 "Faulty Customer" shall have the meaning set forth in Section 6.6.
1.12 "Faulty Plasma" shall have the meaning set forth in Section 6.6.
1.13 "Faulty Processing" shall have the meaning set forth in Section 6.6.
1.14 "FDA" shall mean the United States Food and Drug Administration or
any successor agency or body.
1.15 "First Subsequent Period" shall have the meaning set forth in Section
2.4.
1.16 "GAAP" shall mean generally accepted accounting principles in the
United States consistently applied.
1.17 "Governmental Authorities" shall mean any office, department or
agency of the government of the Territory having jurisdiction over any aspect of
the manufacture, sale or distribution of the Product.
1.18 "Inadequate Yield" shall have the meaning set forth in Section 6.6.
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1.19 "Informational Materials" shall have the meaning set forth in Section
3.4.
1.20 "Initial Purchase Order" shall have the meaning set forth in Section
2.2.
1.21 "Input" shall mean human blood plasma provided to VITEX by the ANRC
pursuant to the terms of this Agreement which plasma meets the specifications
set forth in Schedule 1.21 hereto.
1.22 "Input Loss" shall have the meaning set forth in Section 6.6.
1.23 "Know-How" shall mean all proprietary technical information,
including processes, formulae, designs and data, owned or possessed in whole or
part by VITEX relating to the manufacture or use of the Product. Know-How
existing as of the Effective Date is specified in Schedule 1.23.
1.24 "Marketing Expenses" shall have the meaning set forth in Section 3.3.
1.25 "Marketing Materials" shall have the meaning set forth in Section
3.3.
1.26 "Marketing Committee" shall have the meaning set forth in Section
4.6.
1.27 "Minimum Purchase Requirements" shall have the meaning set forth in
Section 3.6.
1.28 "NYBC" shall mean the New York Blood Center, Inc., a New York not-
for-profit corporation, with its headquarters at 000 Xxxx 00xx Xxxxxx, Xxx Xxxx,
Xxx Xxxx 00000.
1.29 "Party" or "Parties" shall mean VITEX or the ANRC or both, as the
case may be.
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1.30 "Patent Rights" shall mean all patents and patent applications owned
and/or licensed by VITEX relating to the manufacture, use or sale of the
Product. Patent Rights existing as of the Effective Date are listed in Schedule
1.30.
1.31 "Period One" shall mean the period which commenced when the FDA
released the first lot of the Product for delivery to the ANRC and ended on
September 30, 1998.
1.32 "Period Two" shall mean the period commencing October 1, 1998 and
ending on September 30, 2000.
1.33 "Person" shall mean an individual, corporation, partnership, limited
liability company or any other entity, or any government or agency or political
subdivision of a government.
1.34 "PLA" shall mean a Product License Application submitted for approval
by the FDA. "S/D Plasma PLA" shall mean the PLA for solvent/detergent-treated
human blood plasma for transfusion submitted by the NYBC for filing with the FDA
on February 28, 1993, as revised on July 11, 1994. Pursuant to the Amended and
Restated Asset Transfer Agreement between NYBC and VITEX, dated February 7,
1995, the S/D Plasma PLA was transferred from NYBC to VITEX.
1.35 "Product" shall mean the product referenced in the S/D Plas+SD, which
product is a human blood plasma, pooled and treated to inactivate virus and
intended for transfusion as such or following minor changes in composition.
Purified plasma derivatives, such as coagulation factor concentrates,
fibrinogen, immunoglobulin, prepared from Virus-inactivated plasma are not
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covered by this Agreement. The Product is also known under the names VIPLAS/SD,
Plas Plus or S/D Plasma and conforms to the specifications set forth in Schedule
1.35. The Product is manufactured by processing Input using VITEX's Proprietary
Rights.
1. 36 "Proprietary Rights" shall collectively mean Patent Rights and Know-
How.
1. 37 "Purchase Order" shall mean a form of irrevocable take or pay
purchase order for the Product from the ANRC to VITEX in the form of Schedule
1.37 hereto.
1.38 "Quarterly Report" shall have the meaning set forth in Section 5.8.
1.39 "Registration(s)" shall mean any consent, approval or authorization
of, filing or registration with, notification to or other action with respect to
Governmental Authorities in the Territory required to be completed in order to
market and commercially distribute each Product.
1.40 "SOPs" shall mean VITEX's standard operating procedures for
inspection of the Input hereunder, as approved by the ANRC and as the same may
be amended from time-to-time by VITEX with the approval of the ANRC, which
approval will not be unreasonably withheld.
1.41 "Subsequent Generation Product(s)" shall mean a new form of virus-
inactivated human blood plasma, pooled and treated to inactivate virus and other
viruses and intended for transfusion which is the subject of a new PLA or a
supplement or amendment of the S/D Plasma PLA, such new PLA, supplement or
amendment covering a product with substantially altered quality or character,
not simply a therapeutic indication or use of an approved product. Examples of
such Subsequent Generation Product include virus-inactivated human blood plasma
8
product intended for transfusion, the processing of which includes two virus
inactivation methods, or which is further processed to remove blood type-
specific antibodies.
1.42 "Subsequent Period(s)" shall mean every twelve (12) consecutive month
period following Period Two during the Term which commences on the anniversary
of the commencement of Period Two occurring after the end of Period Two.
1.43 "Target Yield" shall have the meaning set forth in Section 6.6.
1.44 "Term" shall have the meaning set forth in Section 7.1.
1.45 "Territory" shall mean the states of the United States of America,
its Territories and Possessions of the United States of America, the District of
Columbia, Canada, Mexico and the Commonwealth of Puerto Rico.
1.46 "Unit" shall mean two hundred (200) milliliters of frozen liquid
Product, prepared within VITEX's manufacturing specifications and intended for
use in patients.
SECTION 2
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GRANT OF DISTRIBUTION RIGHTS
2.1 Grant of Distribution Rights. Subject to the terms and conditions set
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forth herein, VITEX hereby grants to the ANRC an exclusive, non-transferable
right to promote, distribute, market and sell, but not process or manufacture
the Product for commercial use in the Territory (the "Distribution Rights").
The Product shall be processed or manufactured by, or on
9
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
behalf of, VITEX. VITEX agrees that it will not grant Distribution Rights to
the Product in the Territory to any third party during the Term of this
Agreement, except as provided herein.
2.2 Purchase Orders for Period One and Period Two. In consideration
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of VITEX's grant of the Distribution Rights to the ANRC, the ANRC agreed to
purchase from VITEX and placed with VITEX, a Purchase Order equal to
************************** ************ Units of the Product during Period One
for the purchase price provided for in the Initial Agreement (the "Initial
Purchase Order"). The Initial Purchase Order is hereby amended
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***********************************************************. The ANRC places
with VITEX a Purchase Order for Period Two for
************************************* Units to be delivered by VITEX as closely
as reasonably possible at the rate of ************* **************************.
The ANRC hereby agrees to provide VITEX sufficient Input on a timely basis in
order to permit VITEX to meet its production schedule for fulfilling the
Purchase Orders during Period One, Period Two and any Subsequent Periods. The
production schedule for Period One was attached as Schedule 2.2 to the Initial
Agreement. The production schedules for Period Two and Subsequent Periods will
be provided by VITEX or the ANRC within sixty (60) days after receipt by VITEX
of the Purchase Order related to such period. All Input provided to VITEX
pursuant to this Agreement will meet the specifications set forth in Schedule
1.21.
2.3 Additional Takedowns. While the ANRC will not be obligated to purchase
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more than *************************************** Units during Period Two, if
VITEX can process more than ***************************************** Units
during
10
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
Period Two, it is the present intention of the ANRC to purchase all of this
excess production subject to market demand, and it will provide the Input for
this purpose, if available.
2.4 Subsequent Takedowns After Period Two. In order for the ANRC to
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maintain the Distribution Rights hereunder, (i) the ANRC will be required to
purchase pursuant to Purchase Orders delivered to VITEX ************** prior to
the commencement of the Subsequent Period immediately following Period Two (the
"First Subsequent Period") with respect to the First Subsequent Period and
************** prior to the commencement of any other Subsequent Period with
respect to that Subsequent Period a minimum of ****************
******************* Units of the Product during such First Subsequent Period and
for every other Subsequent Period during the Term, and (ii) the ANRC must supply
Input to VITEX in accordance with the terms of this Agreement.
2.5 Obligation to Make Payments. Once a Purchase Order is delivered to and
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accepted by VITEX in accordance with the terms hereof, the ANRC will be required
to pay VITEX the amounts payable under the Purchase Order, even if the ANRC
fails to deliver, or delivers insufficient, Input or the ANRC fails to accept
delivery of the Product when available. In circumstances where VITEX is unable
to produce the Product as a result of a breach of this Agreement by the ANRC,
the ANRC will be required to pay VITEX the amounts as provided for in Section
5.1(a) and Section 5.4 when the Product would otherwise be available to the ANRC
if adequate Input has been delivered by the ANRC on a timely basis as provided
in this Agreement. In circumstances where VITEX is unable to deliver the Product
as a result of a breach of this Agreement by VITEX, the ANRC will not be
required to pay the amounts as provided in Section 5.1 and Section 5.4.
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SECTION 3
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OBLIGATIONS OF ANRC
3.1 Agreement to Purchase/Exclusivity. In exercising the Distribution
---------------------------------
Rights, the ANRC agrees that it shall purchase all of its requirements for the
Product from VITEX. Except as provided in this Section 3.1, the ANRC shall not
at any time during the Term, directly or indirectly through an Affiliate or any
other party, promote, distribute, market, sell or otherwise deliver the Product
or any similar product for use within the Territory, or provide Input to produce
such other product for use within the Territory, unless such product has been
processed and manufactured by, or on behalf of, VITEX. Notwithstanding the
foregoing, the ANRC may promote, distribute, market, sell or otherwise deliver a
Competitive Product. The ANRC will promptly notify VITEX if the ANRC has
determined to promote, distribute, market, sell or otherwise deliver a
Competitive Product.
3.2 Sales Activities. The ANRC shall conduct sales activities pursuant to
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the Distribution Rights by purchasing the Product from VITEX for resale to and
use by its customers in the Territory. The ANRC shall conduct all sales
activities hereunder in a manner consistent with the highest standards of fair
trade, fair competition and business ethics and shall cause all of its
Affiliates, agents and employees to do the same. The ANRC agrees to conduct all
of its activities under this Agreement in accordance with applicable laws, rules
and regulations.
3.3 Marketing Strategies. In exercising the Distribution Rights, the ANRC will
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develop reasonable and appropriate marketing strategies for the Product in the
Territory and will promote actively the features and benefits of the Product in
the Territory. To this end, the ANRC
12
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
will produce labeling, package inserts, patient instructions, promotional
materials, plans for distribution and other related materials as reviewed by the
Parties (collectively the "Marketing Materials"). The ANRC shall submit
Marketing Materials to VITEX for its review before such Marketing Materials are
used by the ANRC. The ANRC agrees to budget and spend at least
********************************** in cumulative expenses during calendar years
1998 and 1999 which include expenses for all direct marketing, direct selling,
promotional, educational, advertising and similar activities previously reviewed
by VITEX (collectively "Marketing Expenses"). These Marketing Expenses are
designed to exclusively benefit the Product or Subsequent Generation Product(s)
produced by or for VITEX based on VITEX's Proprietary Rights and the budget for
Marketing Expenses will be determined and mutually agreed upon by the Parties in
advance. Schedule 3.3 represents the ANRC's initial Marketing Expenses
Proposal. Some allocation for direct sales force selling time expense, not to
exceed********************************* over the calendar years 1998 and 1999,
will be part of the ANRC budget for Marketing Expenses.
3.4 Informational Materials.
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(a) Availability. In exercising the Distribution Rights, the ANRC
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shall establish and follow appropriate and reasonable standards and procedures
regarding the promotion, distribution, marketing and sale of the Product as
required by applicable Governmental Authorities, and in accordance therewith the
ANRC shall make all informational materials required by Governmental
Authorities, including but not limited to patient instructions and package
inserts (collectively "Informational Materials"), available to each physician,
customer or other user to whom a Unit of Product is distributed or delivered.
The ANRC shall
13
not exercise its Distribution Rights with respect to any Unit of Product without
including appropriate portions of the Informational Materials applicable to the
Product. The ANRC shall submit any Informational Materials to VITEX for its
review and approval before any such Informational Materials are used by the
ANRC.
(b) Changes. The ANRC shall make changes in any Informational
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Materials subject to VITEX's prior approval (i) immediately upon receipt or
development of new information with respect to the Product or otherwise, to the
extent necessary to keep the Informational Materials fully accurate at all times
and (ii) as required by applicable Governmental Authorities.
3.5 Quality Assurance. In exercising the Distribution Rights and its
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obligations hereunder to form pools of Input and ship Input to and Product from
VITEX's processing facility, the ANRC shall establish and maintain appropriate
quality control review procedures in accordance with the requirements of all
Governmental Authorities and shall promote, market, distribute and sell the
Product in the Territory in accordance with the requirements of all applicable
Governmental Authorities, the highest standards of quality and medical ethics
prevailing in the blood plasma industry , and in compliance in all material
respects with all applicable laws and regulations. The ANRC shall immediately
notify VITEX if the quality of any Unit of the Product does not meet mutually
accepted quality levels as determined by the Parties from time to time and as
reflected in the specifications in Schedule 1.35 or any finding by the FDA with
respect thereto. The ANRC shall promptly notify VITEX if the quality of any
human blood plasma used to create Input does not meet the specifications for the
Input or a finding by the FDA of which the ANRC becomes aware with respect to
such human blood
14
plasma used to create the Input or with respect to the formation of pools or
shipping or storage of Input or the Product which is the responsibility of the
ANRC hereunder. From time to time, and upon reasonable notice to the ANRC of no
less ten (10) days, VITEX shall have the right to audit the ANRC's compliance
with the requirements of the FDA with respect to this Agreement. In the event
of a finding by VITEX that the ANRC is not in compliance, VITEX shall provide
notice of its findings to the ANRC. In response to such notice, the ANRC shall
respond to VITEX regarding such notice and shall include in such response steps
(if any) which the ANRC will undertake to address such findings. The ANRC
agrees to take all reasonable and appropriate steps to insure compliance with
the requirements of the FDA, relevant to SOPs and specifications set forth in
Schedule 1.21.
3.6 Minimum Purchase Requirements.
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(a) The ANRC agrees that it shall be subject to certain minimum purchase
requirements (the "Minimum Purchase Requirements") with respect to its purchase
of the Product from VITEX during the Term of this Agreement. The Minimum
Purchase Requirements for the Territory are set forth in Section 2.2 for Period
One and Period Two and Section 2.4 for any Subsequent Period. If the ANRC fails
to undertake these minimum purchase commitments in the form of Purchase Orders
timely delivered to VITEX as provided herein and pay for the same or fails to
supply the necessary amount of Input which after processing will provide the
requisite amount of the Product on a timely basis all as provided in this
Agreement, then VITEX shall have the right in its sole and absolute discretion
to (1) terminate this Agreement if VITEX determines in its reasonable judgment
that the ANRC has not exercised its reasonable best efforts to achieve
significant market penetration and/or the ANRC is not using its reasonable best
efforts
15
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
to perform its marketing duties and distribution objectives hereunder or Input
delivery responsibilities hereunder;
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(b) In the event that after September 30, 2000 VITEX shall have capacity in
excess of that needed to meet the Minimum Purchase Requirements, VITEX shall
have the right to notify the ANRC of this situation in writing and may request
that the ANRC increase its Purchase Orders and delivery of Input and accept such
increased supply of the Product. The ANRC shall have ************************
days from the date of such notice to provide VITEX with amended Purchase Orders
reflecting the increased capacity and a commitment to provide Input. Should the
ANRC not provide VITEX with such amended Purchase Orders and a commitment to
provide Input in the requisite time, *********************************
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***********
16
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
3.7 Universal Availability and Resale Prices.
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(a) *************************************************************
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***************************
(b) In exercising its Distribution Rights in the Territory, the ANRC
agrees as follows:
(i ) The Product shall be made available to every hospital, blood center
or other customer in the Territory on commercially reasonable terms;
(ii) In the event that availability of the Product is insufficient to meet
the demand, supplying the Product to blood centers pursuant to preexisting
contractual commitments shall take preference over supplying the Product to
other blood centers, hospitals or customers outside of preexisting contractual
commitments; and
(iii) In the event that it becomes necessary to allocate supply of the
Product due to inadequate availability of the Input, the Product shall be
supplied pro rata on the basis of preexisting contractual commitments without
preference among blood centers, hospitals or other customers.
17
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
(c) If the ANRC elects to terminate a contractual commitment to supply the
Product to a blood center, the ANRC shall provide such blood center, with a
written notice thereof at least ************** in advance of the ANRC's intent
to terminate. Notwithstanding the foregoing, the ANRC may terminate such
contractual commitment in the event of a material breach of the contractual
commitment by the blood center, effective immediately upon written notice to the
breaching party by the ANRC.
3.8 Compliance with Law. In exercising the Distribution Rights, the ANRC
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agrees to comply with all laws and regulations applicable to the ANRC in the
conduct of its activities hereunder or otherwise applicable to the ANRC's
business.
3.9 Distribution. In exercising the Distribution Rights, the ANRC shall:
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(a) Develop A Market. Subject to the terms hereof, develop a market
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for the Product within the Territory. Such efforts shall include, without
limitation, development of educational and training programs for blood centers,
blood banks, hospitals and other health care providers and distribution of
patient information packages.
(b) Monitor Use. Monitor the distribution and dispensation of the
-----------
Product in the Territory to ensure that such distribution and dispensation is
accomplished in accordance with this Agreement.
3.10 Information. In exercising the Distribution Rights, the ANRC shall
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promptly inform VITEX of any new development which relates to the Product of
which the ANRC may become aware which may have any adverse affect on either
Party's ability to perform its
18
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
obligations hereunder or which concerns any serious health risk or unexpected
reaction believed to be associated with or attributed to the use of the Product.
3.11 Reimbursement. The ANRC shall reimburse VITEX as provided in Section
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4.2. The ANRC shall provide VITEX with replacement Input as promptly as
possible if such Input is rejected by VITEX as provided in Section 4.2.
SECTION 4
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OBLIGATIONS OF VITEX
4.1 Agreement to Manufacture. Subject to the conditions set forth in this
------------------------
Agreement, VITEX agrees to manufacture and process Input and deliver the Product
required by the ANRC to exercise its Distribution Rights hereunder.
4.2 Quality Assurance.
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(a) Following receipt of each shipment of Input at VITEX's processing facility
in Melville, Long Island, New York, VITEX shall inspect, or otherwise
ascertain, the conformity of the Input with the requirements of the FDA,
the relevant VITEX SOPs and the specifications set forth in Schedule 1.21.
Prior to release for processing hereunder, each unit of Input shall be
visually examined and verified against accompanying documentation (i.e.
100% inspected). VITEX shall have the right to reject any units which do
not meet SOPs, FDA standards or the specifications of Schedule 1.21, or
which are otherwise damaged, possibly contaminated, improperly packaged,
labeled or stored, which are the subject of a lookback or which are not
properly documented. VITEX must notify the ANRC of any such rejected units
within ********************** of VITEX's completion of inspection thereof.
All rejected units are
19
["****" indicates material omitted and filed separately with the Securities
and Exchange Commission Pursuant to a request for confidential treatment.]
to be destroyed when VITEX is notified to do so by the ANRC, or if notification
is not promptly received by VITEX, VITEX may hold the rejected units at the
expense and risk of the ANRC for a period of thirty (30) days, after which VITEX
may dispose of them in accordance with its SOPs. VITEX shall provide to the
ANRC documentation of any destruction of such units. The costs of destruction
and disposition of the rejected units will be for the account of the ANRC.
(b) In the event (1) the ANRC notifies VITEX of any non-conformity or
unsuitability if any unit of Input after the same has been accepted and pooled,
or (2) VITEX notifies the ANRC of any non-conformity or unsuitability of a pool
as provided in Section 4.2(a), and the pool is thereby deemed unsuitable,
**********************************************
***************************************************** VITEX shall cooperate
with the ANRC in any reasonable efforts requested by the ANRC to correct the
deficiencies including any retesting, reprocessing, or additional processing and
testing of the unsuitable pool, such activity of VITEX shall be at the sole cost
and expense of the ANRC. VITEX shall be responsible for the storage and
handling of Input once it is delivered to VITEX by the ANRC unless provided
otherwise in this Agreement.
(c) Effective January 1, 1999, VITEX will assume responsibility for (i)
the transportation of Input from locations designated by the ANRC and agreed to
by VITEX (ii) pooling of Input at a location or locations prior to transfer to
VITEX's processing facility in Melville, Long Island, New York, and (iii) for
transportation of Input from the pooling facility to VITEX's processing facility
in Melville, Long Island, New York.
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(d) VITEX shall promptly notify the ANRC if the quality of the Product does
not meet the specifications for the Product or a finding by the FDA of which
VITEX becomes aware with respect to the Product or with respect to shipping or
storage of the Input or the Product which is the responsibility of VITEX
hereunder. From time to time and upon reasonable notice to VITEX of no less
than ten (10) days, the ANRC shall have the right to audit VITEX's compliance in
inspecting the Input, with the requirements of the FDA, the relevant VITEX SOPs,
the specifications set forth in Schedule 1.21 and this Agreement. In the event
of a finding by the ANRC that VITEX is not in compliance, the ANRC shall provide
notice of its findings to VITEX. In response to such notice, VITEX shall
respond to the ANRC regarding such notice and shall include in such response the
steps (if any) which VITEX will undertake to address such findings. VITEX will
promptly advise the ANRC of the finding of any inspection or examination by the
FDA of VITEX's activities as it relates to this Agreement of which VITEX is
aware. VITEX agrees to take all reasonable and appropriate steps to ensure
compliance with the requirements of the FDA, relevant SOPs and specifications
set forth in Schedule 1.35.
4.3 Visits. From and after the date the ANRC commences purchasing of the
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Product from VITEX, VITEX may at its sole discretion make representatives of
VITEX available to the ANRC in the Territory for the purpose of aiding in
introduction and penetration of the Product in the Territory.
4.4 Maintaining Registrations. VITEX shall be responsible at its sole expense,
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for obtaining and maintaining any required Registrations in the Territory,
including, but not limited to, all reporting and updating and the preparation
and submission of all amendments and
21
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
supplements thereto and other requirement of the applicable Governmental
Authorities. All Registrations shall remain the sole and exclusive property of
VITEX.
4.5 Marketing Support. VITEX agrees to make every reasonable effort to
------------------
respond to a request by the ANRC for specific marketing support with respect to
the promotion of the features and benefits of the Product in the Territory.
VITEX agrees to budget and spend
******************************************************** in cumulative Marketing
Expenses during calendar years 1998 and 1999. Schedule 4.5 represents VITEX's
initial Marketing Expenses proposal in this regard.
4.6 Right of First Refusal. VITEX hereby agrees to provide the ANRC with a
----------------------
right of first refusal ("ROFR") for exclusive distribution rights in the
Territory for the Subsequent Generation Product(s). Pursuant to this ROFR, if
the Subsequent Generation Product(s) become available during the Term, the
Parties agree to negotiate in good faith the terms and conditions of the
distribution rights with respect to such Subsequent Generation Product(s). This
ROFR shall not be available to the ANRC if VITEX has the right to terminate this
Agreement because of a material breach by the ANRC of this Agreement or
otherwise as provided in Section 7.2(a) and the period to cure such breach has
expired. A Subsequent Generation Product shall be deemed to become available
for this purpose no later than the receipt of a Registration from the FDA with
respect to such Subsequent Generation Product. Should the Parties not be able
to reach a mutually binding contract within a ninety (90) day period from the
date VITEX advises the ANRC of the prospective availability of the Subsequent
Generation Product(s), then VITEX shall have the right to negotiate with any
other Person for the distribution rights in the Territory for the Subsequent
Generation Product(s). Prior to entering into the initial contract with a third
22
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
party with respect to the distribution rights in the Territory for a Subsequent
Generation Product, VITEX shall disclose to the ANRC the key terms of any such
alternative proposal. The ANRC shall have thirty (30) days therefrom to enter
into a binding contract with VITEX on terms and conditions matching in all
material respects the key terms of the alternative proposal. VITEX will be
required to accept the ANRC proposal. If the ANRC does not enter into a binding
contract with VITEX within such thirty (30) day period, VITEX may for a period
of ninety (90) days be free to enter into a binding agreement with respect to
the alternative proposal. In the event VITEX enters into such a binding
agreement with a third party, VITEX shall thereafter not be required to offer
the ANRC a ROFR with respect to such Subsequent Generation Product.
SECTION 5
---------
SALES PROCEDURES
5.1 Price.
-----
(a) Compensation Payable by the ANRC to VITEX for the Product - Period One and
--------------------------------------------------------------------------
Subsequent Periods. The sales price of the Product to the ANRC for Period
------------------
One and Subsequent Periods shall be the Base Price per Unit of the Product,
plus a quarterly "royalty" of
**************************************************************** per Unit
of the Product (such **** as adjusted as provided in Section 5.1(c) being
the "Base Sale Price") times the number of Units of the Product sold in
such quarter. The "Average Selling Price" shall mean the weighted average
selling price of a Unit of Product by the ANRC to an end user or a Person
which is not an Affiliate of the ANRC net of commissions or fees paid to
third parties which are
23
["****" indicates material omitted and filed separately with the Securities
and Exchange Commission Pursuant to a request for confidential treatment.]
not Affiliates of the ANRC and which commissions and fees have been reviewed and
approved by the Marketing Committee as commercially reasonable.
(b) Compensation Payable by the ANRC to VITEX for the Product - Period
------------------------------------------------------------------
Two. The sale price of the Product to the ANRC for Period Two shall be the Base
---
Price plus a royalty determined as provided in this Section 5.1(b). If the
number of Units produced by VITEX during a month is less than ****** for such
month, the royalty for the month would be ***** times the number of Units
produced by VITEX in such month. If the number of Units produced by VITEX
during a month is ****** or more Units but not more than ******* Units, the
royalty shall be ***** per Unit plus an additional royalty of
**************************
************************************************************* (but such
additional royalty shall not exceed ***** per Unit) times the number of Units
produced by VITEX in such month. If the number of Units produced by VITEX
during a month is greater than ******* Units, the royalty shall be
**************************************************
********************************* times the number of Units produced by VITEX in
such month.
(c) Adjustments to Base Price, and Base Sale Price. The Base Price and the
----------------------------------------------
Base Sale Price shall each be adjusted prospectively by
*************************** ***************for the period October 1, 1998
through October 1, 2000 commencing October 1, 2000 for the period October
1, 2000 to October 1, 2001, and thereafter on each anniversary of such date
during the Term, each of the Base Price and the Base Sale Price will be
adjusted prospectively by ************************************ for the
immediate previous twelve month period ended on such anniversary date. The
ANRC agrees to negotiate in good faith an
24
["****" indicates material omitted and filed separately with the Securities
and Exchange Commission Pursuant to a request for confidential treatment.]
additional prospective adjustment to each of the Base Price and the Base Sale
Price of up to an additional
******************************************************* for the period October
1, 1998 through October 1, 2000 commencing October 1, 2000 for the period
October 1, 2000 to October 1, 2001, and thereafter on each anniversary of such
date during the Term the ANRC agrees to negotiate in good faith, an additional
prospective adjustment of each of the Base Price and the Base Sale Price of up
to an additional ********************************** ********** for the immediate
previous twelve month period ended on such anniversary date.
(d) Additional Payments by the ANRC.
-------------------------------
(i) In the event any additional labor, material or packaging,
including relabeling is required in meeting the packaging specifications or any
special delivery conditions of the ANRC (including, without limitation, any
effort VITEX is requested to take relating to any Informational Materials), the
ANRC will reimburse VITEX for VITEX's actual additional costs, provided (a) such
costs have been approved in advance by the ANRC and (b) to the extent such
additional costs arise from packaging materials, the ANRC shall have been given
the opportunity to supply such materials directly to VITEX. In the event the
ANRC orders Units of the Product which may entitle VITEX to such additional
payments, and the ANRC fails to approve such additional payments, any ensuing
dispute shall be resolved in accordance with the provisions of Section 8.2.
(ii) Any and all taxes, including customs duties (other than income taxes)
assessed to VITEX by federal, state, or local governments on sales of the
Product to the ANRC shall be paid by the ANRC.
25
["****" indicates material omitted and filed separately with the Securities
and Exchange Commission Pursuant to a request for confidential treatment.]
5.2 Ordering Procedures ******************************************
--------------------
*************after the Effective Date, the ANRC shall provide VITEX with sales
forecasts in a form (rolling twelve months) agreed to by the Parties setting
forth the expected number of Units which the ANRC reasonably expects to purchase
from time to time. The Purchase Orders shall be placed by the ANRC and filled
by VITEX in accordance with this Agreement and upon such other additional
procedures and upon such other terms and conditions as the Parties may agree
from time to time.
5.3 Shipment Terms and Storage. Prior to January 1, 1999 the ANRC will be
--------------------------
responsible for the collection and pooling of Input and for all shipment and
delivery of pooled Input to VITEX's processing and manufacturing facility or
other location designated by VITEX, and VITEX agrees to reimburse the ANRC for
reasonable costs incurred in pool formation by the ANRC of the Input and
reasonable costs including insurance costs incurred in shipping the pooled Input
to VITEX's processing and manufacturing facility or other location designated by
VITEX and from VITEX's facility to the ANRC central facility for distribution of
the Product in the Territory which central facility must be in the continental
United States. All such shipments of the Product shall be f.o.b. at VITEX's
manufacturing facility or other place designated by VITEX from time to time. On
and after January 1, 1999, the ANRC shall be responsible for the collection and
storage of Input prior to delivery to VITEX. VITEX shall be responsible for the
pick up and transportation of Input from the ANRC's blood centers or other
locations agreed by the Parties hereto, the transportation thereof from such
locations to a central pooling facility, the pooling of the Input and the
transportation of the Input to VITEX's processing facility for the manufacture
of the Product. All storage and transportation costs of Input once delivered to
26
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
VITEX by the ANRC shall be at the sole expense of VITEX; provided, however
that all storage costs of the Product shall be at the sole expense of the ANRC,
if the ANRC fails to take delivery of the Product substantially in accordance
with the delivery schedule provided by VITEX to the ANRC.
5.4 Payment Terms. (a) Period One and Subsequent Periods - For Product
------------- ---------------------------------
produced prior to October 1, 1998 and after September 30, 2000, payments
respecting the Product shall be paid to VITEX by the ANRC as follows: The ANRC
shall pay VITEX ********************
********************************************************************************
********************************************************************************
******************************************************** The royalty set forth
in Section 5.1(a) for the Product produced before October 1, 1998 and after
September 30, 2000 shall be paid by the ANRC to VITEX **************** after the
close of each calendar quarter during which the Product was produced.
(b) Period Two. For Product produced on and after October 1, 1998 and before
----------
September 30, 2000; payment shall be made by the ANRC for the Product promoted,
marketed, distributed and sold by the ANRC and its Affiliates as follows. The
ANRC will pay VITEX
********************************************************************************
********************************************************************************
*************. For Product produced on and after October 1, 1998 and before
September 30, 2000, the royalty due VITEX for a calendar quarter shall be paid
****************
********************************************************************************
****************************************************************************
27
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
********************************************************************************
********************************************************
(c) *************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
**************************************
5.5 Unanticipated Cost Escalation. The Base Price for the Product is
------------------------------
based in part on VITEX's estimate of its full scale production costs. VITEX is
not aware of any imminent substantial increase in its manufacturing costs.
Nevertheless, should VITEX's full scale production costs suffer unanticipated
increases in the future (including but not limited to the regulatory imposition
of new environmental or product testing costs), the ANRC will agree to negotiate
in good faith an increase in the Base Price which reflects VITEX's increased
full sale production costs.
5.6 ****************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************
28
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************. This price rebate
will be adjusted pro rata as the Base Price is adjusted as provided in Section
5.1(a).
5.7 Marketing Committee.
---------------------
(a) Subject to Section 10.6, the activities of VITEX under Section 4.5 and
of the ANRC under Section 3.3 shall be coordinated by a Marketing Committee
consisting of the Vice President Marketing and Sales for VITEX, and a
counterpart from the ANRC and whatever other members the Parties jointly
determine. The Marketing Committee shall meet at least monthly for the first
six (6) months during calendar year 1998 and at least quarterly thereafter.
(b) The ANRC shall use its best efforts in realizing the market goal of
maximum market penetration in the Territory. Irrespective of the magnitude of
the ANRC's purchases from VITEX, if the VITEX senior representative on the
Marketing Committee reasonably determines that the ANRC is not exercising its
best efforts towards full market penetration, VITEX will have the right to
request greater resources and/or programs to remedy the deficiencies. If the
ANRC
29
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
does not comply with this request, VITEX and the ANRC will negotiate in good
faith to find some resolution to the situation. If the Parties cannot identify
a mutually satisfactory resolution, VITEX may terminate this Agreement.
(c) Each Party agrees to notify the Marketing Committee of consumer
complaints regarding the Product. The Marketing Committee shall be responsible
for formulating responses to such complaints.
5.8 Records and Reports
-------------------
(a) Sales Records. The ANRC shall maintain, and cause its Affiliates to
-------------
maintain, in accordance with GAAP, complete and accurate records of all sales of
the Product.
(b) Reports. Each Party agrees to provide the other Party with the reports
-------
which are its responsibility as set forth in Schedule 5.8. Reports shall be
produced on a prompt and timely basis.
5.9 ******************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
***************
30
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
SECTION 6
---------
ALLOCATION OF RISKS; DEFENSE OF PATENT RIGHTS
6.1 Indemnity .
----------
(a) Except as provided in Section 6.1(b), the ANRC shall indemnify and hold
harmless VITEX, its officers, directors, agents, employees and Affiliates (the
"VITEX Indemnitees") from any claim or suit (based on any injury, illness,
disease, allergy, allergic reaction, side effect, death or other adverse
experience) and from all , losses and expenses, including without limitation
reasonable attorney fees, costs and expenses the VITEX Indemnitees may incur as
a result of ******************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
*****************************, provided however, that upon learning of the
filing of any such claim or suit, VITEX shall promptly notify the ANRC and
permit the ANRC, at the ANRC's cost, to handle and control such claim or suit
and shall cooperate in the defense thereof.
(b) Except as provided in Section 6.1(a), VITEX shall indemnify and hold
harmless the ANRC, its officers, directors, agents, employees and
Affiliates (the "ANRC Indemnitees") from any claim or suit (based on any
injury, illness, disease, allergy, allergic reaction, side effect, death or
other adverse experience) and from all losses and expenses, including
without limitation
31
["****" indicates material omitted and filed separately with the Securities
and Exchange Commission Pursuant to a request for confidential treatment.]
reasonable attorney fees, costs and expenses the ANRC Indemnitees may incur as a
result of ***
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
****************************************provided however, that upon learning of
the filing of any such claim or suit, the ANRC shall promptly notify VITEX and
permit VITEX, at VITEX's cost, to handle and control such claim or suit and
shall cooperate in the defense thereof.
6.2 Exclusion of Warranty.
---------------------
(a) VITEX MAKES NO REPRESENTATIONS OR WARRANTIES WHATSOEVER AS TO THE
PRODUCT OR ITS DESIGN, VALUE, EFFICACY OR FREEDOM FROM DEFECTS IN DESIGN OR
MANUFACTURE OR OTHERWISE EXCEPT AS SPECIFICALLY PROVIDED HEREIN. ALL WARRANTIES
OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND OTHERWISE ARE EXPRESSLY
EXCLUDED.
(b) The ANRC MAKES NO REPRESENTATIONS OR WARRANTIES WHATSOEVER AS TO THE
INPUT OR ITS DESIGN, VALUE, EFFICACY OR FREEDOM FROM DEFECTS IN DESIGN OR
MANUFACTURE OR OTHERWISE EXCEPT AS SPECIFICALLY PROVIDED HEREIN. ALL WARRANTIES
OF MERCHANTABILITY,
32
FITNESS FOR A PARTICULAR PURPOSE AND OTHERWISE ARE EXPRESSLY EXCLUDED.
6.3 Insurance or Equivalent. Each Party shall maintain, at its sole expense,
-----------------------
at all times, during the term of this Agreement, the insurance coverage set
forth in Schedule 6.3, with respect to its activities relating to the Product in
the Territory. Such insurance coverage shall be maintained in an amount not
less than the amount required by this Agreement and with carriers with an A.M.
Best rating of not less than A. Such insurance policy shall be written as
primary policy coverage and not contributing with, or in excess of any insurance
which the other Party shall carry with respect to the obligations of each Party
under this Agreement. Each insurance policy shall provide that at least thirty
(30) days' prior written notice of cancellation of, or material change which
reduces the terms, amounts and conditions below that which are required herein,
shall be given to the other Party. Each Party shall furnish certificates of
insurance to the other on or before the date the Distribution Rights are
initially granted hereunder thereafter upon request by the other Party. VITEX
shall supply evidence of its property insurance on an XXXXX "Evidence Property
Insurance" Form 27. In the event each Party shall cease selling the Product as
a result of the termination of the Distribution Rights or otherwise, VITEX may
satisfy its obligations under this Section 6.3 by purchasing discontinued
product liability insurance for such period as the ANRC may reasonably approve
and providing coverage comparable to the ANRC's general liability insurance in
effect at that time. During the Term of this Agreement, each Party shall have
the right to obtain certificates of insurance from the other Party that
insurance coverage is maintained by the other Party. From time to time but at
least annually,
33
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
upon request from the other Party, each Party shall provide to the other Party
notice of insurance coverage maintained by it to satisfy its obligations under
this Section 6.3.
6.4 No Warranty Against Infringement. Neither VITEX nor the ANRC makes
--------------------------------
any representation or warranty to the other that the Product will not infringe
the patents, trademarks, trade names, or other intellectual property rights in
the Territory of any other Person. VITEX is not aware, on the Effective Date,
of any claim of such infringement by any other Person.
6.5 No Consequential Damages. NOTWITHSTANDING ANYTHING HEREIN TO THE
------------------------
CONTRARY, UNDER NO CIRCUMSTANCES SHALL VITEX OR THE ANRC BE LIABLE TO EACH OTHER
OR ANY OTHER PERSON FOR ANY INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL
DAMAGES, INCLUDING BUT NOT LIMITED TO LOST GOODWILL OR LOST PROFITS.
6.6 Risk Allocation. Liability and risk associated with returns and recalls of
----------------
the Product shall be allocated as follows.
******************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
**************************************** The ANRC will bear the out-of-pocket
costs of ************************************************. The ANRC will be
required to pay VITEX's full processing costs (but not any profit) for
************* to pay the logistical and other direct costs of the recall
procedure and to supply VITEX with sufficient Input
34
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
to produce and manufacture replacement Units.
**************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
**********which constituted such Input Loss plus any pooling cost associated
with that Input already paid to VITEX by the ANRC plus interest at the
applicable federal rate if such payment is not made by VITEX within six months
after the date it is due. Payments referred to in the immediately preceding
sentence shall be due 30 days after the occurrence of the event giving rise to
the payment. In addition, VITEX will bear the out-of-pocket costs of a
**********************. To the extent the actual yield of Units of the Product
from donor units of the Input fall below the Target Yield,
***************************************** ************************************
In the case of a Faulty Processing or an Input Loss,
********************************************************************************
********************************************************************************
*********************************************************. In all other
instances of recalls or Product returns that do not fall into one of the three
prior categories, the Marketing Committee will review the matter. If the
Marketing Committee cannot reach a mutually satisfactory resolution, VITEX and
the ANRC will negotiate in good faith to find some resolution to the situation.
If the two Parties hereto cannot identify a mutually satisfactory
35
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
resolution, the matter will be submitted to arbitration pursuant to Section 8.2.
In no event shall either Party be liable to the other for special, incidental or
consequential damages, punitive damages, lost profits and other losses. For
purposes of this Agreement, ********************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
****************************************************************
36
6.7 Patent Enforcement.
-------------------
(a) The ANRC shall promptly provide written notification to VITEX, in the
event the ANRC becomes aware of any third party infringement or possible
infringement of the Patent Rights. Upon receipt of such notice and subject to
VITEX's rights under the Exclusive License Agreement (#3) For Virally
Inactivated Transfusion Plasma Products between VITEX and the New York Blood
Center, Inc., VITEX shall have the right, but not the obligation, to take
appropriate legal action in connection therewith. In the event that VITEX
elects to take such action, the conduct of the action shall be entirely directed
by VITEX, and VITEX shall pay all costs and expenses associated therewith and
retain all recoveries of any such action. However, in the event that VITEX
elects not to take such action, then VITEX shall elect to grant in writing to
the ANRC the right to xxx in its own name, at its own expense and for its own
benefit, any such infringement under the Patent Rights. In such event, VITEX
agrees that it will cooperate with the ANRC. Further, if the ANRC prevails in
such action, the ANRC shall retain any recoveries up to and including an amount
equal to the ANRC's reasonable costs and expenses incurred in bringing the
action. Any recoveries in excess of such amounts shall be divided equally
between VITEX and the ANRC.
(b) The ANRC agrees to report to VITEX, promptly and in written detail, each
claim of patent infringement of which the ANRC becomes aware based solely
on ANRC's exercise of the Distribution Rights. In the event of litigation
against the ANRC on account of any such claim, and upon the ANRC's
providing notice of same to VITEX, within ten (10) days after service
thereof upon the ANRC, VITEX shall undertake the defense of any such
litigation at its own cost and expense. Alternatively, at VITEX's option,
VITEX may permit the ANRC to
37
["****" indicates material omitted and filed separately with the Securities
and Exchange Commission Pursuant to a request for confidential treatment.]
defend, and in such event, the ANRC shall have the right to reimburse itself
fully from up to ******************* of each future payment to VITEX becoming
due hereunder, following the filing of each such suit, for all its expenses
arising out of, or in connection with, the defense of such suit. In either
event, each Party shall cooperate with the other, including providing witnesses,
documents or other evidence in its possession relating to the defense of such
litigation. In the event that VITEX, having undertaken the defense of such
suit, discovers that the claim against the ANRC is not based solely upon the
ANRC's exercise of the rights granted herein, then to the extent such claim is
based on actions taken by the ANRC outside of the scope of the Distribution
Rights hereunder, the ANRC shall reimburse VITEX for VITEX's costs and expenses
to such extent, as well as any amounts paid in settlement or to satisfy
judgments to such extent.
SECTION 7
---------
TERM, TERMINATION AND RENEWAL
7.1 Term. Unless sooner terminated by a Party hereto, this Agreement
----
shall remain in effect for four (4) years and nine (9) months from the
commencement of Period One (the "Term"). The expiration or termination of this
Agreement or any part hereof shall not release the ANRC or VITEX from any
liability which at the time of expiration or termination has already accrued, or
which thereafter may accrue.
38
7.2 Termination Prior to Term.
-------------------------
(a) By VITEX. Subject to the right of the ANRC to have any dispute
--------
hereunder resolved in accordance with the provisions of Section 8.2, this
Agreement may be terminated immediately by VITEX whenever any of the following
events occur:
(i) the ANRC's failure to pay all sums due VITEX hereunder as and when
due, which failure is not cured within fifteen (15) days after receipt of notice
that such payment has not been paid when due;
(ii) the ANRC's failure to maintain insurance as required by Section
6.3, which failure is not cured within fifteen (15) days after receipt of notice
from VITEX that the ANRC is in breach of its obligations under this Agreement to
maintain insurance;
(iii) any other material breach of this Agreement or a Purchase Order
by the ANRC not cured within ninety (90) days after receipt written of notice
thereof from VITEX;
(iv) a court of competent jurisdiction enters a decree or order of
relief (1) with respect to the ANRC in any voluntary or involuntary case or
proceeding under any bankruptcy, insolvency or similar law or (2) appointing a
receiver, liquidator, assignee, trustee or similar official of the ANRC or any
substantial part of its assets, and such decree or order is consented to by the
ANRC or continues unstayed and in effect for a period of sixty (60) days;
(v) the ANRC files a voluntary petition or acquiesces in or fails to
contest an involuntary petition, or an involuntary petition is filed against the
ANRC and is not
39
dismissed within sixty (60) days, in any case or proceeding under any
bankruptcy, insolvency or similar law;
(vi) the ANRC makes a general assignment for the benefit of
creditors;
(vii) the ANRC is dissolved or liquidated;
(viii) the ANRC is prevented from performing its obligations
hereunder by any law, governmental or other action (other than laws of general
application) and has not resumed such performance, in compliance with all
applicable laws, within one hundred twenty (120) days following the date as of
which performance was prevented;
(ix) the ANRC fails to provide VITEX with Input as required in
this Agreement;
(x) the ANRC fails to timely deliver to VITEX a Purchase Order as
provided in this Agreement;
(xi) VITEX exercises its rights under Section 3.6(a) or Section
5.7; or
(xii) in the event the conditions for termination arise as
provided in Section 10.7.
If any of these events should occur, then and in addition to the other
rights and remedies which VITEX may have at law or in equity, VITEX may, at its
option, upon written notice to the ANRC and subject to the rights of the ANRC
under the provisions of Section 8.2: (1) immediately terminate this Agreement
and all Distribution Rights hereunder in their entirety; or
40
(2) convert any rights granted herein with respect to the Product and/or any
country or territory within the Territory to non-exclusive rights and in which
event the ROFR rights of the ANRC will terminate. In the event VITEX converts
the rights pursuant to items (2) above, VITEX reserves the right at any time
thereafter to terminate this Agreement or the Distribution Rights in their
entirety. Any action by VITEX shall be effective as of the date specified in
the notice.
(b) By the ANRC. Subject to the right of VITEX to have any dispute
-----------
hereunder resolved in accordance with the provisions of Section 8.2, this
Agreement may be terminated by the ANRC whenever any of the following events
occur:
(i) any material breach of this Agreement by VITEX not cured within
ninety (90) days after written receipt of notice thereof from the ANRC;
(ii) VITEX's failure to maintain insurance as required by Section 6.3,
which failure is not cured within fifteen (15) days after receipt of notice from
the ANRC that VITEX is in breach of its obligations under this Agreement to
maintain insurance;
(iii) a court of competent jurisdiction enters a decree or order of
relief (1) with respect to VITEX in any voluntary or involuntary case or
proceeding under any bankruptcy, insolvency or similar law or (2) appointing a
receiver, liquidator, assignee, trustee or similar official of VITEX or any
substantial part of its assets, and such decree or order is consented to by
VITEX or continues unstayed and in effect for a period of sixty (60) days;
(iv) VITEX files a voluntary petition or acquiesces in or fails to
contest an involuntary petition, or an involuntary petition is filed against
VITEX and is not dismissed
41
within sixty (60) days, in any case or proceeding under any bankruptcy,
insolvency or similar law;
(v) VITEX makes a general assignment for the benefit of
creditors;
(vi) VITEX is dissolved or liquidated;
(vii) VITEX is prevented from performing its obligations
hereunder by any law, governmental or other action (other than laws of general
application) and has not resumed such performance, in compliance with all
applicable laws, within one hundred twenty (120) days following the date as of
which performance was prevented; or
(viii) in the event the conditions for termination arise as
provided in Section 10.7.
If any of these events should occur, then and in addition to the other
rights and remedies which the ANRC may have at law or in equity, the ANRC may,
subject to the rights of VITEX under the provisions of Section 8.2, immediately
terminate this Agreement by written notice, which shall set forth the event or
events of default that have occurred. The termination shall be effective as of
the date specified in the notice.
(c) By Either Party. Subject to the right of any Party to have any
---------------
dispute hereunder resolved in accordance with the provisions of Section 8.2.,
this Agreement may be terminated upon thirty (30) days prior written notice from
the terminating Party to the non-terminating Party in the following
circumstances:
42
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
***************************************************************************
***********************
***************************************************************************
*********************************************
Notwithstanding the foregoing, (i) a Party giving the above notice
must give it within thirty (30) days of the event giving rise to the right of
termination and (ii) no Party who is then in material breach of this Agreement
shall have the right to exercise the right of termination provided for in this
subsection (c) during the pendency of such material breach or if such Party's
breach resulted in the failure to meet such sales levels.
7.3 Obligations Upon Termination or Expiration. Upon termination or
------------------------------------------
expiration of this Agreement the mutual rights and obligations of the Parties
shall forthwith terminate to the extent of such termination; provided that no
---------
such expiration or termination shall terminate or otherwise affect (i) the
Parties' respective obligations under Section 5. 4 (to the extent payments are
due on the date of termination), 6.6, Section 8.2, and Section 9.4, as
applicable, (ii) any right or obligation accruing hereunder prior to such
expiration or termination, or accruing thereafter in respect of any event
occurring prior thereto and (iii) unless VITEX shall notify the ANRC of its
objection to further sale of the Product, the ANRC shall have the right to
dispose of its existing inventory of the Product (including the Product ordered
prior to termination but delivered after termination) in the ordinary course of
business during the six (6) month period following the date of termination.
After such termination or expiration, (a) VITEX shall not be required to accept
any new Purchase Orders from the ANRC or fulfill Purchase Orders that have not
been delivered
43
as of the date of termination and (b) except as expressly set forth above, the
ANRC shall immediately discontinue selling, marketing and distributing the
Product. In the event of any termination pursuant to Section 7.2(a) above, the
ANRC shall immediately (a) assign and transfer to VITEX any and all rights the
ANRC may have with respect to any Registrations relating to the Product to the
extent permissible under applicable law and (b) make available, transfer and
assign to VITEX any other information available to the ANRC with respect to any
Registrations and the Product. In the event of any termination pursuant to
Section 7.2(b) above, VITEX shall provide the ANRC with such assistance as may
be reasonably requested by the ANRC in order to enable the ANRC to arrange for
an alternative processing source for the Product, provided, however such
alternative processing source must enter into a license agreement with VITEX in
form and substance reasonably satisfactory to VITEX for the utilization of
Patent Rights to process Input to manufacture the Product. Upon termination or
expiration of this Agreement, except as provided in Section 6.6(4), VITEX shall
return all unprocessed Input to the ANRC and complete the processing of all
pooled Input to the extent reasonably possible.
7.4 Termination By the ANRC. The ANRC may terminate this Agreement
-----------------------
without liability if within thirty days after the Effective Date, (i) the ANRC
receives a written opinion of its legal counsel addressed to the ANRC that the
Product cannot be manufactured, used or sold in the Territory based upon the
valid, United States patent rights of persons other than VITEX and the NYBC and
(ii) the ANRC notifies VITEX of such termination and its receipt of such opinion
and the ANRC provides a copy of such opinion to VITEX.
44
SECTION 8
---------
INTERPRETATION AND ENFORCEMENT
8.1 Rules of Interpretation.
-----------------------
(a) Waiver. The waiver by either Party hereto of a breach or default
------
in any of the provisions of this Agreement by the other Party shall not be
construed as a waiver of any succeeding breach of the same or other provisions;
nor shall any delay or omission on the part of either Party to exercise or avail
itself of any right, power, or privilege that it has or may have hereunder
operate as a waiver of any breach or default by the other Party.
(b) Headings. The headings of the articles and sections of this
--------
Agreement are inserted for convenience only and shall not be deemed to
constitute a part hereof.
(c) Separability. If any provision of this Agreement is found by any
------------
panel of arbitrators referred to in Section 8.2 below or by any court of
competent jurisdiction to be invalid or unenforceable, the invalidity of such
provision shall not affect the other provisions of this Agreement and all
provisions not affected by such invalidity or unenforceability shall remain in
full force and effect.
8.2 Resolution of Disputes. Any dispute arising out of or relating to any
----------------------
provision of this Agreement or to the Parties' performance of any of their
respective obligations hereunder, whether or not any such dispute involves a
cause of action or claim for relief within the jurisdiction of a court of law or
equity, shall be resolved in the following manner: such dispute shall be set
forth in writing by representatives of both VITEX and the ANRC and shall
promptly
45
be presented to the duly appointed representatives of VITEX and the ANRC. Such
duly appointed representatives shall forthwith negotiate in good faith in order
to resolve such dispute as soon as possible. If, within ten (10) days after the
submission of any such dispute to them, such representatives are unable to work
out a mutually agreeable solution, or to agree to continue such good faith
negotiations for an additional period of time, such dispute shall be settled by
arbitration before a panel of three (3) arbitrators chosen by such
representatives within ten (10) days after they determine that they cannot
resolve any dispute by their good faith negotiations. If such representatives
cannot agree upon the selection of the arbitrators, the arbitrators shall be
selected according to the Rules of the American Arbitration Association as at
the time in effect. Such arbitration shall take place in New York City, New
York in accordance with such Rules. Any decision of the arbitrators shall be
final and binding upon the Parties, and the Parties expressly agree to abide by
any equitable relief granted in such arbitration. The Parties shall bear the
costs, including attorneys' fees, in connection with any such arbitration in
accordance with the arbitrators' determination thereof. Judgment upon any award
of the arbitrators may be entered in any court of competent jurisdiction.
Except in cases of purported fraud, no Party to the arbitration shall have any
right to bring any action to challenge any such arbitration award hereunder, nor
shall it be permitted to oppose any petition to confirm such an award hereunder.
Notwithstanding the foregoing, either Party hereto may seek equitable relief in
a court of competent jurisdiction.
8.3 Governing Law. This Agreement is made and executed in the State of
-------------
New York and shall be governed by the laws of the State of New York in all
respects, without regard to
46
principles of conflicts of law, including matters of validity, construction,
performance and remedy.
SECTION 9
---------
PARTIES' RELATIONS
9.1 No Assignment. This Agreement shall not be assignable by either party
-------------
without the prior written consent of the other Party, which consent shall not be
unreasonably withheld. Notwithstanding the foregoing, either Party may, without
the consent of the other Party, assign this Agreement to a transferee or
successor in interest of all or substantially all of the business to which this
Agreement relates, whereupon this Agreement shall bind and inure to the benefit
of any such transferee, successor or assignee; provided however that any such
transferee, successor or assignee shall expressly assume in writing the
performance of all of the terms and conditions of this Agreement to be performed
by it.
9.2 Distributors and Agents. The ANRC may, with the prior written
-----------------------
approval of VITEX, which approval shall not be unreasonably withheld, appoint as
distributors or agents entities which are not FDA licensed blood centers for the
sale, distribution and promotion of the Product in the Territory or any part
thereof, provided that the appointment thereof shall not relieve the ANRC of any
of its responsibilities hereunder.
9.3 Relationship Between Parties. The ANRC and VITEX agree that in all
----------------------------
matters relating to this Agreement they are and shall be acting as independent
contractors and shall bear all of their expenses in connection with this
Agreement. Neither the ANRC nor VITEX is, and
47
shall not hold itself out as, an agent, partner or joint venturer of the other.
Neither the ANRC nor VITEX shall have any authority to assume or create any
obligation, express or implied, on behalf of the other. Neither the ANRC nor
VITEX shall make quotations or write letters in the name of the other but in
every instance shall use its own name.
9.4 Confidential Information.
------------------------
(a) Disclosure to Third Parties. During the term of this Agreement
---------------------------
and after termination of this Agreement for any reason neither Party shall, nor
shall it permit its respective directors, trustees, officers, employees,
independent contractors, consultants, agents, or Affiliates to use or disclose
to any third party, except as may be required by the FDA or other Governmental
Authorities, any proprietary information received from or related to the other
Party hereto, including, without limitation, any information relating to the
Proprietary Rights and the Product or otherwise relating to any technology,
know-how, trade secrets, designs, methods, customer information, practices,
ideas, discoveries, processes and other information relating to the business of
the other Party (all information set forth above referred to collectively as the
"Confidential Information") except as permitted in writing by the other party,
and except as specifically permitted hereunder. Each party shall be permitted
to disclose to any of its directors, trustees, officers, employees, independent
contractors, consultants and agents with a need to know, such portion of such
Confidential Information as is necessary to permit such party to exercise any
right or perform any obligation hereunder, provided that each such party
acknowledges and agrees to be bound by the terms of this Section.
48
(b) Exceptions. Confidential Information shall not include information
----------
which (i) was at the time of disclosure generally known to the public through no
fault of the receiving party of the Confidential Information, (ii) subsequently
becomes generally known to the public other than by breach of this Agreement,
(iii) the receiving party, by documentary evidence, can demonstrate was known to
or in the possession of the receiving party prior to disclosure by the
disclosing party, or (iv) the receiving party, by documentary evidence, can
demonstrate became known to the receiving party subsequent to disclosure by the
disclosing party through a third party having no obligation of confidentiality
to the disclosing party.
(c) Disclosure of Confidential Information. If either Party hereto
--------------------------------------
becomes legally compelled to disclose any Confidential Information of the other
Party, that Party will promptly notify the other Party so that the other Party
may seek a protective order or other appropriate remedy and/or waive compliance
with the provisions of this Agreement. If a protective order or other remedy is
not obtained, or if the other Party waives compliance with the provisions of
this Agreement, the disclosing Party or such other person shall furnish only
that portion of the Confidential Information which such Party is legally
required to disclose and such Party will not oppose any action by the other
Party to obtain other reliable assurance that confidential treatment will be
accorded such Confidential Information.
(d) Further Action. Each of the Parties shall take such further
--------------
action as shall be reasonably requested by the other Party to ensure the
safeguarding and confidentiality of the other Party's Confidential Information.
49
(e) Limitation. The ANRC recognizes that VITEX may wish to sell securities
----------
which may be registered under the Securities Act of 1933, as amended or in one
or more private placements. The foregoing provisions of this Section shall not
restrain VITEX from making disclosures which its counsel recommends pursuant to
such Act, the Securities Exchange Act of 1934, as amended or to a purchaser in a
private placement.
(f) The provisions of this Section shall survive termination,
cancellation or expiration of this Agreement and of the Amended Restated First
Collaboration Agreement, as amended and restated.
9.5 Publicity. The Parties agree not to issue any press release or
---------
other public statement disclosing the existence of or relating to the terms and
conditions of this Agreement without the prior written consent of the other
Party. Notwithstanding, neither Party shall be prevented from complying with
any duty of disclosure it may have pursuant to law or from making such
disclosures as counsel recommends in connection with potential or actual legal
disputes with third parties.
9.6 Use of Tradenames and Trademarks. The Parties agree not to use
--------------------------------
directly or indirectly the other Party's tradenames or trademarks in connection
with promotions, advertising or sales activity without the prior written consent
of the other Party. All material in connection with such activities which is
submitted by one Party to the other Party for its consent shall be in compliance
with the consenting Party's written specifications for the use of its tradenames
or trademarks. Any consent granted under this Section shall not excuse any
failure to comply with such specifications. If a Party determines that the
other Party's use of its
50
tradenames and trademarks is not in compliance with such Party's written
specifications, then that Party shall be entitled to request that the other
Party refrain from using such tradenames or trademarks within three (3) days
from the receipt of written notice of such request. Notwithstanding any consent
previously given, a Party may revoke its consent as to specific uses of its
tradenames or trademarks provided however that such revocation shall not take
effect until the supply of such material in existence before such revocation
has been exhausted.
SECTION 10
----------
MISCELLANEOUS
10.1 Entire Agreement. This Agreement and the Schedules hereto, which are
----------------
an integral part hereof, embody the entire understanding between the Parties
with respect to the subject matter hereof. The Parties agree that no
representations have been made or relied upon, except as specifically stated in
this Agreement. Notwithstanding the foregoing, this Agreement shall not
supersede the Amended Restated First Collaboration Agreement.
10.2 Modifications. This Agreement may be modified only by a writing
-------------
signed by both Parties.
10.3 Notices. Unless otherwise specifically provided, all notices,
-------
demands, or requests required or permitted by this Agreement shall be in writing
and may be delivered personally or by facsimile transmission, or may be sent by
mail, addressed to the addresses set forth below or such other addresses that
the Parties may designate in writing pursuant to this Section 10.3. Any notice
delivered personally or by facsimile transmission shall be deemed received on
the date
51
thereof, and any notice given by mail shall be deemed received on the third
business days after the postmarked date thereof. Nothing contained herein shall
justify or excuse failure to give oral notice for the purpose of informing the
other Party thereof when prompt notification is appropriate, but such oral
notice shall not satisfy the requirement of written notice.
If to VITEX: V.I. Technologies, Inc.
000 Xxxxxx Xxxx
Xxxxxxxx, Xxx Xxxx 00000
Attention: President
with a copy to: Facsimile: (000) 000-0000
Xxxxxxx, Del Deo, Dolan, Griffinger & Xxxxxxxxx
Xxx Xxxxxxxxxx Xxxxx
Xxxxxx, Xxx Xxxxxx 00000
Attention: Xxxxx X. Xxxxxxxx, Xx.
Facsimile: (000) 000-0000
If to the ANRC: American National Red Cross
0000 Xxxx Xxxx Xxxxx, 00xx Xxxxx
Xxxxxxx, Xxxxxxxx 00000-0000
Attention: Xxxxx Xxxx
Facsimile: (000) 000-0000
with a copy to: American National Red Cross
Office of General Counsel
0000 Xxxx Xxxxx Xxxxx, 00xx Xxxxx
Xxxxxxx, Xxxxxxxx 00000-0000
Facsimile: (000) 000-0000
10.4 No Third-Party Benefits. Nothing in this Agreement shall be construed
-----------------------
to confer upon any Person not a Party hereto any right, remedy or claim
hereunder.
52
10.5 Modification of First Collaboration Agreement. To the extent the
---------------------------------------------
provisions in this Agreement are inconsistent with the provisions of the Amended
Restated First Collaboration Agreement, the provisions of this Agreement shall
govern.
10.6 Tax Exempt Status of the ANRC. Notwithstanding any other provision in
-----------------------------
this Agreement, the ANRC shall not be required to engage in any activity that
would jeopardize the charitable tax exempt status of the ANRC nor shall the ANRC
or VITEX be required to engage in any activity that presents a reasonable
likelihood of the imposition of intermediate sanctions under the Internal
Revenue Code of 1986, as amended, on VITEX, the ANRC or managers of the ANRC.
10.7 Severability. In the event implementation of any of the provisions
------------
of this Agreement present a material risk of loss of the ANRC's tax exempt
status or the imposition of intermediate sanctions under the Internal Revenue
Code of 1986, as amended, or if any provision of this Agreement is held invalid,
illegal or unenforceable in any jurisdiction ("Invalid Provision"), the Parties
shall promptly negotiate in good faith a lawful, valid enforceable provision
that is similar in terms to such Invalid Provision as may be possible while
giving effect to the future benefits and burdens accruing to the Parties
hereunder, and which removes the risk, if any, of loss of the ANRC's tax exempt
status and the imposition of intermediate sanctions under the Internal Revenue
Code of 1986, as amended. The remaining provisions of this Agreement shall
remain binding on the Parties hereto. In the event that the Parties cannot agree
on a provision to replace an Invalid Provision, at the ANRC's election, the
Parties shall attempt to renegotiate their relationship in good faith under
commercially reasonable terms, or this Agreement shall terminate under either
Section 7.2(a)(xii) or Section 7.2(b)(viii) of this
53
Agreement. The ANRC does not believe on the date hereof that any provisions of
this Agreement are an Invalid Provision.
54
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed by their duly authorized representatives as of the 17 day of
December, 1998.
V.I. TECHNOLOGIES, INC.
By: /s/ Xxxx X. Xxxx
--------------------------------
Name:
Title:
--------------------------------
AMERICAN NATIONAL RED CROSS
By: /s/ Xxxxxx X. Yenrich
--------------------------------
Name: Xxxxxx X. Yenrich
Title: Contracting Officer
12/17/98
55
SCHEDULES
Schedule 1.21 Specifications of the Input
Schedule 1.23 Know-How
Schedule 1.30 Patent Rights
Schedule 1.35 Specifications of the Product
Schedule 1.37 Form of Purchase Order
Schedule 3.3 ANRC Marketing Expenses Proposal
Schedule 4.5 VITEX Marketing Expenses Proposal
Schedule 5.8 Records and Reports
Schedule 6.3 Insurance Coverage
SCHEDULE 1.21
SPECIFICATIONS OF THE INPUT
---------------------------
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
PLASMA FOR SOLVENT/DETERGENT (SD)
---------------------------------
PLASMA PROCESSING SPECIFICATIONS
--------------------------------
(the "SPECIFICATIONS")
----------------------
1.0 OBJECTIVE
To establish a program for the acceptance of plasma by V.I. Technologies,
Inc. ("VITEX") for use in SD Plasma processing.
2.0 DEFINITIONS
2.1. Plasma for SD Plasma Processing (the "PSDP") - The fluid portion of
whole blood (Human) collected in the U.S. by FDA-licensed blood centers
from volunteer, non-remunerated donors and containing no additives other
than FDA approved anti-coagulant. The plasma must have been drawn from
adult humans who are in good physical condition to give blood, in so far as
can be determined by personal history and physical examination on the date
of collection.
In order for plasma to be acceptable for use in the production of SD Plasma
it needs to meet the requirements for Recovered Plasma (Frozen) or Source
Plasma from plateletpheresis or plasmapheresis as well as the additional
requirements outlined in these SPECIFICATIONS. The plasma shall be
separated from red cells and frozen solid no longer than ******** after
collection. (It is preferable for the plasma derived from a whole blood
collection to be separated from both red cells and platelets, but this is
not required.) The plasma shall be frozen flat and stored continuously at
---
************* or below. Once frozen, plasma may not be thawed.
Plasma for SD Plasma Processing must be collected, prepared (processed),
labeled and stored in accordance with these SPECIFICATIONS and in a manner
fully consistent with plasma or any blood component intended for
transfusion, e.g. FFP or Red Blood Cell Concentrate. PSDP needs to be
labeled by ABO type. As such, PSDP must undergo a blood center's normal
cGMP practices for unit release and labeling and ultimate release for
distribution (i.e. release for transport by VITEX's authorized carrier to
VITEX for SD Plasma Processing) as would be the case for any labeled blood
component intended for transfusion.
VITEX RETAINS THE RIGHT TO REJECT OR OTHERWISE NOT ACCEPT ANY UNITS OF
PLASMA FOR SD PLASMA PROCESSING WHENEVER IT BELIEVES, IN ITS SOLE
DISCRETION, THAT THE UNITS SUPPLIED ARE NOT IN FULL CONFORMANCE WITH THESE
SPECIFICATIONS.
1
2.2 Short Supply Agreement - An agreement between a plasma supplier and
VITEX, signed by the respective Responsible Heads or by their designated
individuals, in accordance with 21 CFR 601.22. By completing and signing
the Short Supply Agreement, the plasma supplier certifies that it has
received these SPECIFICATIONS and has read and understood them, and that
the plasma supplier will abide by all terms and conditions as stated in
these SPECIFICATIONS.
3.0. PROCEDURE
3.1. Within two weeks of the date of the Short Supply Agreement, and upon
any reasonable request by VITEX thereafter while a Short Supply Agreement
between the parties is in effect, the plasma supplier will provide VITEX
with a copy of its current FDA Establishment License.
3.2 The SPECIFICATIONS outlined herein are applicable to plasma used in the
production of products in short supply, as defined in 21 CFR 601.22.
3.3 The following regulations and other requirements apply specifically:
3.3.1. 21 CFR 606.3 through 606.170 - Current good manufacturing practices
for blood and blood components.
3.3.2. 21 CFR 610.40 and 610.41 - Standards for Hepatitis testing.
3.3.3. 21 CFR 610.45 - Human Immunodeficiency Virus (HIV-1/2) requirements
and recommendations).
3.3.4. 21 CFR 640.1 through 640.5 - Standards for collection and testing
of whole blood.
3.3.5. 21 CFR 640.16 and 21 CFR 640.24 - Preparation of plasma and
platelets.
3.3.6. 21 CFR 606.121 - Standards for labeling, including 21 CFR
606.121(c)(12) with respect to ABO labeling requirements.
3.3.7. Plasma for SD Plasma Processing is to be collected only from
volunteer, non-remunerated donors under the age of 59.5. Donor selection,
blood collection and record
2
keeping shall be performed according to FDA approved procedures (including
the requirements of the December 11, 1996 guideline "Interim
Recommendations for Deferral of Donors at Increased Risk for HIV-1 Group O
Infection" and "Revised Precautionary Measures to Reduce the Possible Risk
of Transmission of Creutzieldt- Jakob Disease (CJD) by Blood and Blood
Products") and the procedures defined in the current edition of the AABB
"Standards for Blood Banks and Transfusion Services".
Persons who have received treatment with extracts from human pituitary
glands, such as growth hormone, gonadotropins or thyroid-stimulating
hormone (thyrotropin), are not acceptable as donors. Persons having
received dura mater grafts are not acceptable as donors.
Autologous donors are not acceptable. Plasma that has been irradiated is
not acceptable.
The plasma pooled by VITEX must reflect the original antibody spectrum of
the donor population. It should be neither enriched nor deprived of
special antibodies, either by screening or by adsorption methods, except
for antibodies against HIV, HCV and HTLV. Anti-HBc positive donations
should not be removed. If for its own reasons a plasma supplier wishes to
remove anti-HBc positive donations from its shipments, the supplier must
inform VITEX of this in writing before the first shipment without anti-HBc
positive units is to be shipped to VITEX.
Donor documentation (donor assessment, identification, test results) is to
be kept for at least 10 years.
3.3.8 All units of PSDP must be tested by an FDA approved method and found
negative or non-reactive to the following tests: HBsAg, RCV antibody, HIV-
1/2 antibodies, HIV-1 antigen (HIV- Ag) and Syphilis. (ALT testing is not
required.)
3
3.3.9 Donors of all units of PSDP collected as of February 15, 1998 must be
tested, and found negative, for HTLV-II by an FDA licensed donor screening
test.
3.3.10 Positive antibody screen (red cell antibodies) units are to be
excluded.
3.3.11 Only single units in FDA-approved satellite bags of a closed
multiple system are acceptable. Pooled plasma will not be accepted. The
volume per unit must be at least 160 mL.
3.3.12 The plasma supplier's manufacturing process must assure that plasma
units are free of microbial or pyrogenic contamination, essentially free of
red blood cells, and the hemoglobin content is not to exceed 100mg per
100mL. Grossly lipemic units will not be accepted. Leaking, damaged or
cracked bags are not to be shipped.
3.3.13 Only plasma which has been collected and processed under the
Establishment License number which has been defined in the mutually-agreed
Short Supply Agreement may be delivered to VITEX.
Within two weeks of the date of the Short Supply Agreement, VITEX must be
informed if the HBsAg, anti-HIV 1/2, anti-HCV, HIV-1 antigen or Syphilis
antibody tests are not performed under the same Establishment License as
the Establishment License for the collection and processing operations. In
addition, in those cases where the testing defined in the preceding
sentence is performed under a different Establishment License, the
responsibilities between the plasma supplier (i.e. the blood collection
center) and the testing laboratory must be provided in writing to VITEX.
3.3.14 If FDA requires any additional screening tests or testing
modifications, such testing shall be implemented as soon as required.
4
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
3.4 Prior to freezing, PSDP is to be stored at room temperature (not
refrigerated) whenever allowed under 21 CFR 640 regulations. Units must be
frozen solid within ******** after collection.
3.5 If Fresh Frozen Plasma (FFP) originally prepared from whole blood is to
be used as PSDP, then each unit must be relabeled as Recovered Plasma in
accordance with Section 3.8 below.
3.6 If FFP prepared by plateletpheresis or plasmapheresis is to be used as
PSDP, then each unit must be relabeled as Source Plasma in accordance with
Section 3.8 below. (A blood center will need to hold a Source Plasma
license to ship such material for SD Plasma processing.)
3.7 Prior to shipment to VITEX (or pick-up by its contract carrier),
units of PSDP may be stored at ************************************
*********************************************************
3.8 The labeling on each unit shall comply with all applicable FDA
requirements. The following information shall be displayed on the front of
the plasma bag:
3.8.1 Donor number: each plasma unit has to be labeled with a unique
donor/donation number and labeled with the bar code corresponding to this
number.
3.8.2 Collection date or expiration date.
3.8.3 Name, address, and Registration number of the blood center.
3.8.4 The name "RECOVERED PLASMA" in a prominent position if the unit is
prepared from whole blood or was prepared originally as FFP from whole
blood. The name "SOURCE PLASMA" needs to appear in a prominent position if
the unit originally was prepared as Fresh Frozen Plasma from platelpheresis
or plasmapheresis.
3.8.5 Statement of the volume of plasma and the type of anti- coagulant
used.
3.8.6 Statement to indicate that the plasma was frozen within ********
after collection.
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
3.8.7 Recommended storage temperature, i.e., store at or below
************.
3.8.8 Statement that the plasma is non-reactive for HBsAg, HIV-Ag and
negative for antibodies to HIV-1/2 and HCV by FDA approved tests.
3.8.9 The statement: "CAUTION: FOR MANUFACTURING USE ONLY".
3.8.10 The unit must indicate ABO type. (Note: Rh + or - may be included
on the label, but is not required; either is acceptable for SD Plasma
processing.)
3.8.11 Any bar code symbology used on the label must comply with current
approved FDA guidelines.
3.8.12 Examples of product labels that conform to the requirements of
this Section 3.8 are shown in FRAP0001G/4 and FRAP0001G/5, attached to
these SPECIFICATIONS.
3.9 The shipment of each ABO type represents a separate shipment for
documentation purposes. Therefore, each shipment requires its own Summary
Control Sheet (see 3.9.5 below) and Xxxx of Lading (see 3.9.6 below). Each
shipment of PSDP must be packaged, labeled and documented as outlined
below:
3.9.1 Only shipping cartons provided by VITEX may be used to ship PSDP to
VITEX.
3.9.2 All units of PSDP must be segregated by type (A, B, O, AB) into
separate shipping cartons at the blood center. Each shipping carton will
hold 20 units of PSDP processed from whole blood. The ABO type will need
to be clearly marked on the shipping carton exterior (see 3.9.3 below). No
mixing of ABO type will be allowed.
3.9.3 Each shipping carton of plasma must be labeled with the approved
label provided by VITEX. The label is to be placed in the space indicated
on the shipping carton. The following information is to be entered onto
6
the label (see FRAP0001G/6 for an example of a properly completed shipping
carton label):
3.9.3.1 The name and address of the plasma supplier.
3.9.3.2 The Xxxx of Lading Number.
3.9.3.3 The shipping carton number (e.g. Box 1 of 20) for the shipment.
3.9.3.4 The ABO type is to be designated by circling the applicable type on
the label.
3.9.4 Each shipping carton of plasma must contain a Packing Slip which
includes a list of all of the individual units in that shipping carton.
Donor number and the date of collection or the expiration date are to be
provided on the Packing Slip for each unit. The Packing Slip shall also
include the date and initials of the responsible person, the total number
of units and the total volume (in liters) of plasma in the shipping carton.
(See FRAP0001G/7 for an example of a properly completed Packing Slip.)
3.9.5 Each shipment (by ABO type) must be accompanied by a Summary
Control Sheet referencing each Packing Slip in the shipment, and a copy of
each Packing Slip is to be stapled to the Summary Control Sheet. The
Summary Control Sheet must be enclosed in a sealed plastic bag and placed
in a separate, clearly marked shipping carton. The Summary Control Sheet
must include the name, generation (if applicable) and manufacturer of the
screening tests listed on the Summary Control Sheet and a statement
certifying that all units have been tested and found negative or non-
reactive using FDA- approved tests for the following: HBsAg, HCV
antibodies, HIV- 1/2 antibodies, Syphilis antibodies, and HIV-1 antigen.
The Summary Control Sheet is to be signed and dated by an appropriate
responsible person. (The Summary Control Sheet for shipping PSDP to VITEX
is shown as FRAP0001G/8.)
7
3.9.6 Each shipment (by ABO type) must be accompanied by a properly
completed Xxxx of Lading (BOL). The BOL will include (FRAP0001G/9 provides
an example of a properly completed BOL):
3.9.6.1 The name and address of the processing establishment.
3.9.6.2 A BOL number which will consist in part of a shipper number
assigned by VITEX to each processing establishment shipping PSDP to VITEX
and a sequential shipment number (assigned by the blood center).
3.9.6.3 The date of shipment.
3.9.6.4 The consignee (i.e. VITEX) and the consignee's address (i.e.
c/o Caliber Logistics Healthcare, 000 Xxxx Xxxx Xxxxxxxxx, Xxx Xxxxxx, IN
47150).
3.9.6.5 the number of shipping cartons in the shipment and the
description of contents (i.e. Plasma for SD Plasma Processing), the total
number of units, the total weight in Kg and the total volume in liters.
3.9.6.6 The shipper's signature.
3.9.7 The processing establishment must retain a copy of the Xxxx of
Lading, the Packing Slips, and the Summary Control Sheet for each shipment
to facilitate any future tracking and recovery of a unit shipped to VITEX
for SD Plasma processing.
3.10 To optimize the packaging of plasma units, the following guidelines
are provided:
3.10.1 The bottom of the shipping carton provided by VITEX is to be taped
closed.
3.10.2 PACK ONLY ONE BLOOD TYPE PER SHIPPING CARTON.
3.10.3 Remove all tags and strings from the plasma units.
8
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
3.10.4 Remove tubing segments.
3.10.5 Stand each plasm unit on its side, alternating port direction, with
labels facing in the same direction.
3.10.6 If the shipping carton is not full, add filler material to protect
the plasma units from breakage. NO SHIPPING CARTON WITH LESS THAN TEN (10)
UNITS SHOULD BE SHIPPED TO VITEX.
3.10.7 The Packing Slip for each shipping carton should be enclosed in a
sealed plastic bag to protect it from leaks and then placed inside the
shipping carton.
3.10.8 Each shipping carton is to be sealed with tape.
3.11 Ship cartons containing PSDP (or turn over to the VITEX designated
carrier) at ************* or below.
3.12 Notification and Recall - **************************************
******************************************************************
********************************************************************
*****************************************************************
********************************************************************
*******************************************************************
***********
****** ***********************************************************
******************************************************
************************************************************
***************************************************** *******
****** ***********************************************************
***********************************************************
**************************************************
******** ***********************************************
**************************************************
******************************************
**************************************************
***********************************
9
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
***********************************************
***************************************
******** ***********************************************
***************************************** ***********
3.12.2.3 A recipient develops a post transfusion infection that can be
traced back to the donor.
******** ******************************************
***********************************************
************************************************ ******************
3.12.3 All necessary information (See FRAP0001G11, "PLASMA NOTIFICATION"
form) is to be provided to VITEX (Attention: Quality Assurance Department)
by fax at (000) 000-0000 and the original PLASMA NOTIFICATION form also
mailed to:
Quality Assurance Department V.I. Technologies, Inc. (VITEX) 000 Xxxxxx Xxxx
Xxxxxxxx, XX 00000
3.13 Each blood center shall maintain a quality assurance system that
provides confidence that all systems and elements that influence the
quality and safety of the PSDP are as expected.
3.14 Failure to comply with any of the aforementioned SPECIFICATIONS
shall be sufficient cause for VITEX to reject any PSDP delivered to VITEX.
4.0 RESPONSIBILITIES
4.1 Plasma Suppliers - It is the responsibility of each plasma supplier
to ensure that the collection, preparation, testing, labeling and storage
of all PSDP has been carried out according to all of these SPECIFICATIONS.
A written recall procedure in conformance with current FDA requirements
shall be in place. (See FRAP0001G/10 for Recall and Lookback Procedure
Guidelines.)
10
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
4.2 Transportation Contractor - It is the responsibility of the
Transportation Contractor to pick up and deliver the PSDP in acceptable
condition to the proper storage location. Storage during transit must be
shown to have been carried out at ******** or colder.
4.3 VITEX Records Retention Department - It is the responsibility of
Records Retention to maintain all records associated with shipments of
PSDP.
4.4 VITEX Quality Assurance Inspectors - It is the responsibility of the
Quality Assurance Inspectors to follow the established Warehouse - Quality
Assurance System.
5.0 ADDITIONAL INFORMATION
5.1 VITEX reserves the right to conduct on-site visits, either by the
VITEX Quality Assurance Department or by another qualified party designated
by VITEX, of Plasma Supplier's operations under 21 CFR 601.22. VITEX
reserves the right to reject incoming shipments of Plasma for SD Plasma
Processing that fail to meet these SPECIFICATIONS.
5.2 Short Supply Agreement - Under FDA Establishment License number 386,
VITEX is authorized under the Products in Short Supply regulations to
further manufacture plasma collected at licensed whole blood collection
centers. A signed Short Supply Agreement between the collection center and
the manufacturer, VITEX, shall be available for inspection by FDA
investigators.
5.3 All Packing Slips pertinent to the PSDP units received will remain on
file in the VITEX Records Retention Department.
6.0 DOCUMENTATION
6.1 FRAP0001G/4 - Example of PSDP Label - Recovered Plasma (Frozen).
6.2 FRAP0001G/5 - Example of PSDP Label - Source Plasma.
6.3 FRAP0001G/6 - Example of PSDP Shipping Carton Label.
6.4 FRAP0001G/7 - Example of PSDP Packing Slip.
6.5 FRAP0001G/8 - PSDP Summary Control Sheet.
11
6.6 FRAP0001G/9 - Example of PSDP Xxxx of Lading.
6.7 FRAP0001G/10 - Recall and Lookback Guidelines.
6.8 FRAP0001G/11 - PLASMA NOTIFICATION Form.
6.9 FRAP0010/1 - Short Supply Agreement (Fractionation)
6.10 FRAP0010/2 - Short Supply Agreement (SD Plasma)
If there are any questions with respect to these
SPECIFICATIONS, please contact VITEX, Quality Assurance
Department, by phone: (516) 752-7314 ext. 126 or 127
by fax: (000) 000-0000
12
[Example of PSDP Label - Recovered Plasma (Frozen)]
13
RECALL AND LOOKBACK PROCEDURE GUIDELINES FOR BLOOD CENTERS
------------------------------------------------------------
The plasma supplier providing Plasma for SD Plasma Processing to VITEX shall
have in place a written recall procedure that will include the following:
1. Distribution procedures that will document the production, labeling and
shipment of each plasma unit so that the disposition of the unit can be readily
determined to facilitate its recall, if necessary. Information on the date of
collection, date of shipment, xxxx of lading number, and carton, number shall be
accessible, and whether the plasma is recovered, from plasmapheresis, or from
plateletpheresis.
2. The possible reasons to initiate a recall, e.g. donor reconsideration,
incomplete donor history, testing deficiencies, viral marker reactivity,
positive confirmatory tests, etc. If the unit is considered unacceptable for
transfusion for any reason, VITEX should be notified within seventy- two (72)
hours of such a determination, giving the specific reason as well as all test
results.
3. Procedures for the delegation of the authority to initiate a recall.
4. Lookbacks - instructions should indicate that any FDA-recommended lookback
be performed.
5. CJD - (Creutzfaldt - Jakob Disease) - the conditions under which unit is to
be recalled for CJD of the donor or a relative, in accordance with current FDA
guidelines.
6. For any recall:
. To expedite retrieval of a plasma unit, please fax all necessary
information to VITEX at Fax number (000) 000-0000. The attached PLASMA
NOTIFICATION form (FRAP0001G/11) provides an example of the information to be
provided to VITEX and the appropriate fax and phone numbers.
Also, mail the original to:
Quality Assurance Department
V.I. Technologies, Inc. (VITEX)
000 Xxxxxx Xxxx
Xxxxxxxx Xxx Xxxx 00000
7. The unit being recalled will be destroyed by VITEX (if it is still
available); written notification will be sent confirming that the unit has been
destroyed.
14
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
VITEX PSDP SUMMARY CONTROL SHEET
AND LETTER OF TESTING CERTIFICATION
Blood Center Name: __________________________________
Address: ____________________________________________
City, State, Zip: ______________________________________
FDA License Number: _________________________________
Phone: ______________________________________________
Fax: ________________________________________________
TO: QA Department Phone # (516) 752-7314 ext. 126 or 127
V.I. Technologies, Inc. (VITEX) Fax # (000) 000-0000
000 Xxxxxx Xxxx
Xxxxxxxx, XX 00000
Please be advised that we are shipping one of the following:
_____Recovered Plasma (Frozen, within **** hours). ABO Type - A B AB O (circle
one)
_____Source Plasma. ABO Type - A B AB O (circle one)
Xxxx of Lading Number: ___________ Number of Boxes:____________
The shipment contains ___________ plasma units.
The shipment contains _____________ liters of plasma.
All donations are from bleed date__________to bleed date__________.
All units have been stored at *************** for _________ days.
and ______________at ***************
-------------------------------------------------------------------------------------------------
************** ***************** ********** ************
-------------------------------------------------------------------------------------------------
*****
-------------------------------------------------------------------------------------------------
**************** -
-------------------------------------------------------------------------------------------------
*************
-------------------------------------------------------------------------------------------------
********
-------------------------------------------------------------------------------------------------
*************
-------------------------------------------------------------------------------------------------
***************************************************************************
**********************************************************
__________________________________________________________________
Signature of Responsible Head or Designee Date
15
PLASMA NOTIFICATION
DATE:_________________________
TO: FROM:
Quality Assurance Department Blood Center Name: ___________________
V.I. Technologies, Inc. (VITEX) Address:______________________________
000 Xxxxxx Xxxx Xxxx, Xxxxx, Xxx: ___________________
Xxxxxxxx, Xxx Xxxx 00000 FDA License Number:___________________
(P) 000-000-0000 x 000 or 127 Name: ________________________________
(F) 000-000-0000 Signature:____________________________
Phone: _______________________________
Fax: _________________________________
Our records indicate that we have shipped the following plasma unit(s) to your
facility and have subsequently initiated a recall or lookback. Please destroy
the unit if it has not been further manufactured.
------------------------------------------------------------------------------------------------------
Unit Number BOL # To VITEX Date Shipped Box Number Type of Plasma
------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------
Reason for notification:
Medical History Deferral/Self Exclusion
This unit has been tested and found non-reactive/negative by FDA recommended
viral marker test procedures. Reason for request to destroy plasma unit:
- ------------------------------------------------
- ------------------------------------------------
- ------------------------------------------------
- ------------------------------------------------
- ------------------------------------------------
16
[Example of PSDP Label - Source Plasma]
17
[Example of PSDP Shipping Carton - Label]
18
EXAMPLE OF PSDP PACKING SLIP
-----------------------------
Shipment Information: -
---------------------
Ship Date: Shipment Number:
Shipped to: Shipping Region: -
--------------------------------------------------------------------------------
Carton Information: -
------------------
Carton/Control Number: Units in Carton:
Product Type: Frozen Recovered Plasma Net Weight: Kg-
----------------------------------------------------------------------
Unit Number Coll. Date Unit Number Coll. Date Unit Number Coll. Date
1. 011 017 73 01/20/97 2. 011 017472 01/20/97 3. 011FN57196 01/20/97
4. 011 596 53 01/20/97 5. 011 596061 01/20/97 6. 011FF37544 01/20/97
7. 011FZ34 36 01/20/97 8. 011FC54829 01/20/97 9. 011LX21421 01/20/97
10. 011FZ12 29 01/21/97 11. 011 596040 01/20/97 12. 011FC34836 01/20/98
13. 011FF37 45 01/20/97 14. 011 596050 01/20/97 15. 011FF37842 01/20/97
16. 011 596 57 01/20/97 17. 011 596052 01/20/97 18. 011FC3 824 01/20/97
19. 011FC34132 01/20/97 20. 011 596959 01/20/97
- -----------------------------------------------------------------------------
Carton packed by Date:
--------------------------------
Verified by Date:
-------------------------------------
- ------------------------------------------------------------------------------
19
[Example of PSDP Xxxx of Lading]
20
SCHEDULE 1.23
KNOW-HOW
SCHEDULE 1.23
Know-How
--------
The use of solvent-detergent technology has become widespread in the
preparation of blood derivatives to inactivate lipid-enveloped viruses. Because
viruses which lack lipid envelopes and/or are heat-resistant (e.g. hepatitis A
(HAV) or parvo virus (B19)) may be present the use of two methods of virus
elimination that operates by different mechanisms has been advocated. The
virucidal treatment of plasma or other protein solutions by ultraviolet
radiation and quenchers (UVC) has as its basis the higher absorption of light
energies between 250 and 260 nm by nucleic acid as compared with protein, and
orders of magnitude larger target presented by nucleic acids. The technology
will enhance existing techniques in the use of UVC irradiation by improving
compatibility with labile proteins through the addition of quenchers of reactive
oxygen species (ROS). Adoption of UVC irradiation has been limited in the past
because of the low recovery of coagulation factors when the fluence was
increased to levels required for complete viral inactivation. Current
experimental data indicates that greater than 10/5/ infectious doses of HAV or
porcine parvo virus could be eliminated at 0.1 J/cm/2/ without significant loss
of valuable coagulation factors. Later experiments have shown that a wide range
of viruses can be inactivated by UVC. The addition of NYBC's UVC treatment to
existing processes used in the manufacture of blood components and derivatives
and other therapeutic proteins will provide a substantial added margin of
safety, especially for non-enveloped viruses.
1
UVC irradiation requires a specialized piece of equipment - the irradiator.
To deal with the large volumes of material to be irradiated, a device capable of
handling biological fluids in a continuous flow manner was developed. The
current device allows for accurate exposure of the sample with UVC light without
over or underexposure. This capability is achieved by irradiating a thin film
of liquid that flows down the inside surface of a rapidly rotating cylinder set
at a desired angle. In the interior of the cylinder are positioned several UV
lamps. Since the solution is maintained as a thin film throughout transit, it
is irradiated uniformly. The device was designed to be placed in-line in a
pharmaceutical manufacturing setting and to be run for extended periods. In
order to treat larger quantities of material, multiple units can be run in
parallel and the material repooled following treatment.
The device has a complete array of sensors and fail-safes to continuously
monitor operating parameters, e.g. cylinder rotation speed, light intensity,
fluid flow rates, power, and temperature. The system is computer operated and
is intended to meet government regulations. The KNOW-HOW also includes clinical
data, toxicology data, the results of neoimunogen studies, etc., and such other
general information contained in the laboratory notebooks and reports of Xx. X.
Xxxxxxxx and of the scientific staff reporting to him.
2
SCHEDULE 1.30
PATENT RIGHTS
--------------
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
SCHEDULE 1.30
PATENT RIGHTS
--------------
************************************************************************
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*******************************[3 pages omitted]*************************
*****************************************************************************
*****************************************************************************
*****************************************************************************
*************************************************************
1
SCHEDULE 1.35
SPECIFICATIONS OF THE PRODUCT
-----------------------------
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
SCHEDULE 1.35
SPECIFICATIONS OF THE PRODUCT
-----------------------------
************************************************************************
*****************************************************************************
*****************************************************************************
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*****************************************************************************
*******************************[2 pages omitted]*************************
*****************************************************************************
*****************************************************************************
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1
SCHEDULE 1.37
FORM OF PURCHASE ORDER
----------------------
[Form of Purchase Order]
1
SCHEDULE 3.3
ANRC MARKETING EXPENSES PROPOSAL
--------------------------------
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
Schedule 3.3
ARC MARKETING EXPENSES PROPOSAL
********* (one page omitted) ****************************
1
SCHEDULE 4.5
VITEX MARKETING EXPENSES PROPOSAL
---------------------------------
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
Schedule 4.5
VITEX MARKETING EXPENSES PROPOSAL
********* (one page omitted) ****************************
1
SCHEDULE 5.8
RECORDS AND REPORTS
-------------------
SCHEDULE 5.8
RECORDS AND REPORTS
--------------------
The Reports should discriminate sales (dollars and unit of the Product and
Input) as well as marketing activities directed at customers within a region or
locality by customer class (blood center, hospital and/or other customer).
a) Sales: Nationally, be region, by account, by month and quarter, dollars
and units
b) Sales activity reporting: Nationally, by region, by account, by customer
type/class, by quarter, by representative, including provision for monitoring
targeted special activities, e.g. teleconferences, speakers, training, etc.
c) Database of contracts pending or entered into, by relevant terms:
cost/price, volume, plasma re-purchases ("buy side"), by customer type and
class, i.e. blood center, hospital, blood bank, end-user, intermediaries (BCA),
etc.
1
SCHEDULE 6.3
INSURANCE COVERAGE
------------------
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
SCHEDULE 6.3
INSURANCE COVERAGE
-------------------
Each Party shall maintain at all times during this Agreement the following
insurance policies at its sole cost and expense:
(a) (1) Commercial General Liability Insurance in an amount of at least
********* naming the other Party an additional insured as its interests may
appear;
(2) an auto liability policy with at least ********** in coverage, and;
(3) Workers' Compensation coverage covering each Party's own employees with
statutory limits for each jurisdiction where the work required under this
Agreement is performed (including monopolistic states if any work is to be
performed in one or more of them) and an employers' liability policy with at
least the following limits: ********** per accident, ********** per disease, and
********** per disease (each employee).
(b) (1) VITEX further agrees to maintain full replacement value "All Risk"
property insurance on all property and equipment of VITEX used under this
Agreement, and said property insurance shall insure at all times all the Product
and VITEX agrees to waive any right of subrogation for loss or damage to any
VITEX property at, on, or in VITEX's facilities or in transit. VITEX agrees to
obtain, if required in such property insurance, a waiver of subrogation in favor
of the ANRC. Said property insurance shall include Business Interruption and
Extra Expense coverage for such losses arising from loss or damage to the
aforementioned VITEX
1
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
property without expectation of contribution from any such insurance the ANRC
may maintain.
(2) VITEX further agrees to maintain Product Liability Insurance in an
amount not less than ********** specifically insuring claims arising from the
development, manufacture and use of the Product and the performance by VITEX of
its services to the ANRC, as defined in this Agreement and related material,
including, but not limited to, coverage for all expenses, including attorney's
fees, incurred in the investigation, negotiation, arbitration, and defense of
any suit or claim for damages including lost earnings of the ANRC. Said Product
Liability Insurance shall not exclude claims of a professional nature arising
from VITEX's development of the viral inactivation process.
(c) (1) The ANRC further agrees to maintain Professional Liability
Insurance (including medical malpractice) in an amount not less than **********
specifically insuring claims arising from performance by the ANRC of its
services to VITEX as defined in this Agreement and related material, including,
but not limited to, coverage for all expenses, including attorney's fees,
incurred in the investigation, negotiation, arbitration, and defense of any suit
or claim for damages including lost earnings of VITEX.
2
