["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
EXHIBIT 10.13
SUPPLY, MANUFACTURING, AND
DISTRIBUTION COLLABORATION AGREEMENT
This SUPPLY, MANUFACTURING AND DISTRIBUTION COLLABORATION AGREEMENT (the
"Agreement") is entered into this 15th day of December, 1997, (the "Effective
Date" ) 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").
WITNESSETH:
-----------
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 desires to enter into this 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, VITEX does not have and does not desire to establish a
distribution system for the Product; and
WHEREAS, the ANRC's distribution system is well-suited for professional
distribution of the Product; and
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
WHEREAS, in furtherance of the First Collaboration Agreement and the
parties' desire to extend their collaboration, VITEX desires that the ANRC shall
be solely 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
this Agreement; and
WHEREAS, the First Collaboration Agreement is amended and restated
contemporaneously with this Agreement (the "Amended First Collaboration
Agreement"); and
WHEREAS, the parties desire to set forth such further understandings and
agreements as set forth herein.
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.
---------
DEFINITIONS
When used in this Agreement, the terms set forth in this Section shall have
the following meanings:
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. "Base Price" shall have the meaning set forth in Section 5.1(a).
1.4. "Base Sale Price" shall have the meaning set forth in Section 5.1
(a).
1.5. "Competitive Product" shall mean human blood plasma intended for
transfusion which has been demonstrated ***************************************
********************************************************************************
********************** as compared to the Product, and has received final FDA
approval for the same indications for which the Product is then currently used.
1.6. "Confidential Information" shall have the meaning set forth in
Section 9.4
-2-
1.7. "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.
1.8. "Distribution Rights" shall have the meaning set forth in Section
2.1.
1.9. "FDA" shall mean the United States Food and Drug Administration or
any successor agency or body.
1.10. "GAAP" shall mean generally accepted accounting principles in the
United States consistently applied.
1.11. "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.
1.12. "Informational Materials" shall have the meaning set forth in
Section 3.4.
1.13. "Initial Purchase Order" shall have the meaning set forth in Section
2.2.
1.14. "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 1.14 hereto.
1.15. "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 1.15.
1.16. "Marketing Expenses" shall have the meaning set forth in Section 3.3
.
1.17. "Marketing Materials" shall have the meaning set forth in Section
3.3 .
1.18. "Marketing Committee" shall have the meaning set forth in Section
4.6.
1.19. "Minimum Purchase Requirements" shall have the meaning set forth in
Section 3.6.
1.20. "NYBC" shall mean the New York Xxxxx.Xxxxxx, Inc., a New York not-
for-profit corporation, with its headquarters at 000 Xxxx 0.0xx Xxxxxx, Xxx
Xxxx, Xxx Xxxx 00000.
1.21. "Party" or "Parties" shall mean VITEX or the ANRC or both, as the
case may be.
-3-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
1.22. "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
1.22.
1.23. "Period One" shall mean the *************************** which will
commence when the FDA releases the first lot of the Product for delivery to the
ANRC.
1.24. "Period Two" shall mean the ****************************** period
immediately following the conclusion of Period One.
1.25. "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.
1.26. "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 1, 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.
1.27. "Product" shall mean the product referenced in the S/D Plasma PLA,
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
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
1.27. The Product is manufactured by processing Input using VITEX'S Proprietary
Rights.
1.28. "Proprietary Rights" shall collectively mean Patent Rights and Know-
How.
1.29. "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
1.29 hereto.
1.30. "Quarterly Report" shall have the meaning set forth in Section 5.8.
1.31. "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.
1.32. "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.
-4-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
1.33. "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
product intended for transfusion, the processing of which includes two virus
inactivation methods, or which is further processed to remove blood type-
specific antibodies.
1.34. "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.
1.35. "Term" shall have the meaning set forth in Section 7.1.
1.36. "Territory" shall mean the states of the Xxxxxx Xxxxxx xx Xxxxxxx,
xxx Xxxxxxxx xx Xxxxxxxx, Xxxxxx and Mexico.
1.37. "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.
---------
GRANT OF DISTRIBUTION RIGHTS
2.1. Grant of Distribution Rights. Subject to the terms and conditions
----------------------------
set 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 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. Initial Order. In consideration of VITEX's grant of the
-------------
Distribution Rights to the ANRC, the ANRC agrees to purchase from VITEX and has
placed with VITEX, on or prior to the Effective Date hereof, a Purchase Order
equal to ************************************** Units of the Product during
Period One for the purchase price provided for in this Agreement (the reinitial
Purchase Order"). 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 Initial Purchase Order and all future Purchase Orders during
Period Two and any Subsequent Periods. The production schedule for Period One is
attached hereto as Schedule 2.2. 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 1.14.
-5-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
2.3. Additional Takedowns. While the ANRC will not be obligated to
--------------------
purchase more than ************************************** Units during Period
One, if VITEX can process more than ************************************** Units
during Period One, it is the present intention of the ANRC to purchase all of
this excess production, and it will provide the Input for this purpose if
available.
2.4. Subsequent Takedowns. In order for the ANRC to 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 Period Two with respect to Period Two and ************** prior
to the commencement of any Subsequent Period with respect to that Subsequent
Period a minimum of ************************************ Units of the Product
during Period Two and for every 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 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, except for the royalty set forth in Section
5.1 (a) 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.
SECTION 3.
---------
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 or other 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 the Distribution Rights by purchasing the Product from VITEX for resale to
and use by its customers
-6-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
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 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 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 years 1998 and 1999, will be part of the
ANRC budget for Marketing Expenses.
3.4. International Materials.
-----------------------
(a) Availability. In exercising the Distribution Rights, the ANRC
------------
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 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
-------
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
-----------------
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
-7-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
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
1.27 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 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 1.14.
3.6. Minimum Purchase Requirements.
-----------------------------
(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 shall be ********************
****************** Units of the Product during Period One and *****************
******************* Units of Product during Period Two and for each Subsequent
Period thereafter. The ANRC agrees to provide sufficient Input on a timely basis
to VITEX to meet VITEX's production schedule for fulfilling these Purchase
Orders. These minimum purchase commitments will take the form of Purchase Orders
that will be issued as provided in Section 2.4. 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 to perform
its marketing duties and distribution objectives hereunder or Input delivery
responsibilities hereunder or **************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
**********************************************
-8-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
(b) In the event that in any Subsequent Period 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 ***************
****************** 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, *****************************
********************************************************************************
********************************************************************************
****************************************************************************
**********************
3.7. Universal Availability and Resale Prices.
----------------------------------------
(a) ***************************************************************
*******************************************************************************
*******************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
**************************
(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.
(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.
-9-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
3.8. Compliance with Law. In exercising the Distribution Rights, the ANRC
-------------------
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:
------------
(a) Develop A Market. Subject to the terms hereof, develop a
market 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
-----------
promptly form-NiITEX 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 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 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.
---------
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.
-----------------
(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 1.14.
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 1.14, 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
-10-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
VITEX's completion of inspection thereof. All rejected units are 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 while in VITEX's processing facility in
Melville, Long Island, New York, and for reimbursing the ANRC for pool testing
conducted by the ANRC in accordance with procedures agreed to by both Parties
hereto.
(c) 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 tirade 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 1.14 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 1.27.
4.3. Visits. From and after the date the ANRC commences purchasing of the
------
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, 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 supplements thereto and other
requirement of the applicable Governmental Authorities. All Registrations shall
remain the sole and exclusive property of VITEX.
-11-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
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 two million dollars ($2,000,000) 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
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 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) Base Price of Product. The sales price of the Product to the
---------------------
ANRC shall be ************************ per Unit of the Product, (the "Base
Price") plus a quarterly "royalty" of ****************************************
*********************************** per Unit of the Product (such ***** being
the "Base Sale Price") times the number of Units of the Product sold in such
quarter. Average selling price shall mean the 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.
The Base Price and the Base Sale Price shall be adjusted by *******************
************************ each year Commencing with the first anniversary of the
date of commencement of Period One and on each
-12-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
anniversary thereafter during the Term. The ANRC agrees to negotiate in good
faith an additional adjustment to the Base Price and the Base Sale Price of up
to ******************************************** commencing with the first
anniversary of the date of commencement of Period One arid on each anniversary
thereafter during the Term.
(b) 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.
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. The ANRC shall 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. 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 shipments of the Product shall be f.o.b. at VITEX's
manufacturing facility or other place designated by VITEX from time to time.
All storage costs of Input at VITEX's location and storage costs of the Product
at VITEX's location prior to delivery to 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.
-13-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
5.4. Payment Terms. 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 ****************************************************
********************************************************************************
*******************************************************************************
********************************************************** The royalty set
forth in Section 5.1 (a) shall be paid **************** after the close of each
calendar quarter based on the average price per Unit that the ANRC receives for
sales of the Product during such calendar quarter.
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. *********************************************************************
*********************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
*************************************************** 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
-14-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
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 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.
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 ("Indemnities") 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 Indemnities
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 8 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 Indemnities") 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 ANRC Indemnities
-15-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
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 VTTEX; 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 Representation 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. 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 terns, 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, upon request from the other Party, each Party
shah provide to the other Party notice of insurance coverage maintained by it to
satisfy its obligations under this Section 6.3.
-16-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
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. Recalls and Returns. 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 the Faulty Plasma lot(s), to pay the logistical and other direct costs of
the recall procedure and to supply VITEX with sufficient Input to produce and
manufacture replacement Units. *************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
************************************************************************* which
constituted such Input Loss 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 Faulty Processing case. To the extent
that the actual yield of the Product from Input falls below the ***************
***** minimum 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 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.
-17-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
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
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
-18-
"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.
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 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;
-19-
(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 (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 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
-20-
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 AMRC 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.
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 6.9, 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
priority 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 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.
-21-
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 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.
-22-
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 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 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
-23-
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.
(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.
(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 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.
-24-
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 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 and Restated Collaboration Agreement among the ANRC, VITEX
and the New York Blood Center, Inc. dated the date hereof.
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 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
Facsimile: (000)000-0000
-25-
with a copy to:
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:
Office of General Counsel
0000 Xxxx Xxxxx Xxxxx, 00xx Xxxxx
Xxxxxxx, Xxxxxxxx 00000-0000
Facsimile: (7D3) 312-5728
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.
10.5. Modification of First Collaboration Agreement. To the extent the
----------------------------------------------
provisions in this Agreement are inconsistent with the provisions of the 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
-26-
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 Agreement. The ANRC does not believe on the date hereof
that any provisions of this Agreement are an Invalid Provision.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed by their duly authorized representatives as of the 15th day of
December, 1997.
V.I. TECHNOLOGIES, INC.
By: /s/ Xxxx X. Xxxx
----------------------------
Name: Xxxx X. Xxxx
Title: President
AMERICAN NATIONAL RED CROSS
By:____________________________
Name:
Title:
-27-
SCHEDULES
Schedule 1.14 - Specifications of the Input
Schedule 1.15 - Know-How
Schedule 1.22 - Patent Rights
Schedule 1.27 - Specifications of the Product
Schedule 1.29 - Form of Purchase Order
Schedule 2.2 - Production Schedule
Schedule 3.11 - Testing
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
-28-
SCHEDULE 1.14
SPECIFICATIONS OF THE INPUT
---------------------------
51
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Exchange Commission Pursuant to a request for confidential treatment.]
Page 1 of 12
PLASMA FOR SOLVENT/DETERGENT (sp)
---------------------------------
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.
52
Page 2 of 12
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.
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.
53
Page 3 of 12
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 recordkeeping 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.)
54
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
Page 4 of 12
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.
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.
55
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission Pursuant to a request for confidential treatment.]
Page 5 of 12
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.
3.8.7 Recommended storage temperature, i.e., store at or below
************.
56
Page 6 of 12
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 the label (see FRAP0001G/6
for an example of a properly completed shipping carton
label):
57
Page 7 of 12
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.)
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):
58
Page 8 of 12
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.
59
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Exchange Commission pursuant to a request for confidential treatment.]
Page 9 of 12
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 - **************************************
******************************************************************
********************************************************************
*****************************************************************
********************************************************************
*******************************************************************
***********
****** ***********************************************************
******************************************************
************************************************************
*****************************************************
*******
****** ***********************************************************
***********************************************************
**************************************************
******** ***********************************************
**************************************************
******************************************
**************************************************
***********************************
60
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Exchange Commission pursuant to a request for confidential treatment.]
Page 10 of 12
***********************************************
***************************************
******** ***********************************************
*****************************************
***********
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.)
61
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Exchange Commission pursuant to a request for confidential treatment.]
Page 11 of 12
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.
62
Page 12 of 12
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
63
[Example of PSDP Label - Recovered Plasma (Frozen)]
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.
65
["****" 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
66
PLASMA NOTIFICATION
DATE:_________________________
TO: FROM:
Quality Assurance Department Blood Center Name:
V.I. Technologies, Inc. (VITEX) ---------------------
000 Xxxxxx Xxxx Xxxxxxx:
Xxxxxxxx, Xxx Xxxx 00000 -------------------------------
(P) 000-000-0000 x 000 or 127 City, State, Zip:
(F) 000-000-0000 ----------------------
FDA License Number:
--------------------
Name:
----------------------------------
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 Date Box Type of
VITEX Shipped Number 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:
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
67
[Example of PSDP Label - Source Plasma]
[Example of PSDP Shipping Carton - Label]
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
14. 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:
---------------------------
--------------------------------------------------------------------------------
70
[Example of PSDP Xxxx of Lading]
SCHEDULE 1.15
KNOW-HOW
--------
72
SCHEDULE 1.15
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.
73
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.
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
SCHEDULE 1.22
PATENT RIGHTS
-------------
************************************************************************
*****************************************************************************
*****************************************************************************
*****************************************************************************
*****************************************************************************
*******************************[3 pages omitted]*************************
*****************************************************************************
*****************************************************************************
*****************************************************************************
*************************************************************
75
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
SCHEDULE 1.27
SPECIFICATIONS OF THE PRODUCT
-----------------------------
************************************************************************
*****************************************************************************
*****************************************************************************
*****************************************************************************
*****************************************************************************
*******************************[2 pages omitted]*************************
*****************************************************************************
*****************************************************************************
*****************************************************************************
*************************************************************
79
SCHEDULE 1.29
FORM OF PURCHASE ORDER
----------------------
82
[Form of Purchase Order]
SCHEDULE 2.2
PRODUCTION SCHEDULE
-------------------
84
Date: October 15, 1997
To: DonM
Xxxx
Xxx
Xxxxxx
Xxxx
Re: Xxxx
From: DonH
Subject: Red Cross Ramp Plan
Xxxxxx English of the Red Cross requested an updated production ramp plan
today. Attached please find two rampup plans, one that assumes no FDA lot
release hold and one that assumes an FDA lot release hold. The logic on
the attachments has been reviewed with DonM in advance of sending it to the
Red Cross.
Xxxxxx, let's use these numbers in our updated financial plan.
85
CONFIDENTIAL
SENT VIA FAX
000-000-0000
Date: October 15, 1997
To: Xxxxxx English
American Red Cross
From: Xxxxxx Xxxxxxxxx
Vitex
Subject: Production Ramp Schedule
Attached please find two updated production ramp schedules. The
assumptions page highlights the major assumptions.
The only difference between the two production ramp schedules is the
requirement for an FDA lot release. We have been told recently, on an
informal basis, that the FDA will not require a formal lot release
procedure from the agency. However, we have enclosed two schedules since
the outcome is not yet a certainty. The assumptions are largely similar to
an earlier model shared with the Red Cross.
The "Incoming Liters" column represents the Vitex plasma requirements from
the Red Cross.
Please call me at 000-000-0000, extension 212 if you have any questions.
Best regards.
/s/ Don
86
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
CONFIDENTIAL
Major Production Ramp Assumptions
---------------------------------
The FDA ELA letter is received in the **********************
The Red Cross is the exclusive distributor of the Vitex product.
The Red Cross will begin providing plasma on a regular basis to Vitex during the
week of ***********
The initial production new hire headcount will begin work between **************
Vitex will begin producing *********** at the start of ******** with the
following exceptions:
The FDA inspection, originally assumed for ************, now appears to be
a ******** event. As a result, ********** can be produced the week of the
inspection.
********** can be produced during the week of *************
The FDA inspection outcome is satisfactory.
*********** will be produced in the ******************************
The next group of production new hire head count will begin work on ************
These people will be trained during the weeks of ********* and ********* (i.e.,
the weeks of *********** ************, during which time no lots will be
produced.
FDA license is issued at year end *****
The ramp schedule will begin at *****************************************
increasing at the rate specified on the attachment.
One ramp schedule attachment assumes the normal ****** Vitex lot release period
plus a ****** FDA lot release period. A second ramp schedule attachment assumes
the normal ****** Vitex lot release with no FDA lot release requirement. The
FDA has told Vitex informally that the latter scenario is more likely.
Goods are released to the Red Cross once approximately ************ are produced
and released by Vitex and/or the FDA. This begins the initial ***************
during which time Vitex will produce at least **************
*** production yield. **** units per pool at *** ml/unit. ***************
*************************
87
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
Production Schedule
Number Incoming Saleable Units Cumulative
Week Week of of Fills Liters Units Released Released
--------------------------------------------------------------------------------
03-Nov-97 **** ******** ********
10-Nov-97 **** ******** ********
17-Nov-97 **** ******** ******** ********
24-Nov-97 **** ******** ******** ********
01-Dec-97 **** ******** ******** ********
08-Dec-97 **** ******** ******** ********
15-Dec-97 **** ******** ******** ********
Training 22-Dec-97 **** ******** ******** ********
Training 29-Dec-97 **** ******** ******** ********
05-Jan-98 **** ******** ******** ********
12-Jan-98 **** ******** ******** ********
19-Jan-98 **** ******** ******** ********
26-Jan-98 **** ******** ******** ********
1 02-Feb-98 **** ******** ******** ******** ********
2 09-Feb-98 **** ******** ******** ******** ********
3 16-Feb-98 **** ******** ******** ******** ********
4 23-Feb-98 **** ******** ******** ******** ********
5 02-Mar-98 **** ******** ******** ******** ********
6 09-Mar-98 **** ******** ******** ******** ********
7 16-Mar-98 **** ******** ******** ******** ********
8 23-Mar-98 **** ******** ******** ******** ********
9 30-Mar-98 **** ******** ******** ******** ********
10 06-Apr-98 **** ******** ******** ******** ********
11 13-Apr-98 **** ******** ******** ******** ********
12 20-Apr-98 **** ******** ******** ******** ********
13 27-Apr-98 **** ******** ******** ******** ********
14 04-May-98 **** ******** ******** ******** ********
15 11-May-98 **** ******** ******** ******** ********
16 18-May-98 **** ******** ******** ******** ********
17 25-May-98 **** ******** ******** ******** ********
18 01-Jun-98 **** ******** ******** ******** ********
19 08-Jun-98 **** ******** ******** ******** ********
20 15-Jun-98 **** ******** ******** ******** ********
21 22-Jun-98 **** ******** ******** ******** ********
22 29-Jun-98 **** ******** ******** ******** ********
23 06-Jul-98 **** ******** ******** ******** ********
24 13-Jul-98 **** ******** ******** ******** ********
25 20-Jul-98 **** ******** ******** ******** ********
26 27-Jul-98 **** ******** ******** ******** ********
27 03-Aug-98 **** ******** ******** ******** ********
10/15/97 ******* 1 of 2
88
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
Production Schedule
28 10-Aug-98 **** ******** ******** ******** ********
29 17-Aug-98 **** ******** ******** ******** ********
30 24-Aug-98 **** ******** ******** ******** ********
31 31-Aug-98 **** ******** ******** ******** ********
32 07-Aug-98 **** ******** ******** ******** ********
33 14-Sep-98 **** ******** ******** ******** ********
34 21-Sep-98 **** ******** ******** ******** ********
35 25-Sep-98 **** ******** ******** ******** ********
36 05-Oct-98 **** ******** ******** ******** ********
37 12-Oct-98 **** ******** ******** ******** ********
38 19-Oct-98 **** ******** ******** ******** ********
39 26-Oct-98 **** ******** ******** ******** ********
Assumption: ******** for VITEX QA release
10/15/97 ******** 2 of 2
89
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
Production Schedule
Week Week of Number Incoming Saleable Units Cumulative
of Fills Liters Units Released Released
03-Nov-97 **** ******** ********
10-Nov-97 **** ******** ********
17-Nov-97 **** ******** ********
24-Nov-97 **** ******** ********
01-Dec-97 **** ******** ********
08-Dec-97 **** ******** ********
15-Dec-97 **** ******** ********
Training 22-Dec-97 **** ******** ********
Training 29-Dec-97 **** ******** ******** ********
05-Jan-98 **** ******** ******** ********
12-Jan-98 **** ******** ******** ********
19-Jan-98 **** ******** ******** ********
26-Jan-98 **** ******** ******** ********
02-Feb-98 **** ******** ******** ********
09-Feb-98 **** ******** ******** ********
16-Feb-98 **** ******** ******** ********
23-Feb-98 **** ******** ******** ********
02-Mar-98 **** ******** ******** ********
09-Mar-98 **** ******** ******** ********
1 16-Mar-98 **** ******** ******** ******** ********
2 23-Mar-98 **** ******** ******** ******** ********
3 30-Mar-98 **** ******** ******** ******** ********
4 06-Apr-98 **** ******** ******** ******** ********
5 13-Apr-98 **** ******** ******** ******** ********
6 20-Apr-98 **** ******** ******** ******** ********
7 27-Apr-98 **** ******** ******** ******** ********
8 04-May-98 **** ******** ******** ******** ********
9 11-May-98 **** ******** ******** ******** ********
10 18-May-98 **** ******** ******** ******** ********
11 25-May-98 **** ******** ******** ******** ********
12 01-Jun-98 **** ******** ******** ******** ********
13 08-Jun-98 **** ******** ******** ******** ********
14 15-Jun-98 **** ******** ******** ******** ********
15 22-Jun-98 **** ******** ******** ******** ********
16 29-Jun-98 **** ******** ******** ******** ********
17 06-Jul-98 **** ******** ******** ******** ********
18 13-Jul-98 **** ******** ******** ******** ********
19 20-Jul-98 **** ******** ******** ******** ********
10/15/97 ******** ******** 1 of 2
90
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
Production Schedule
20 27-Jul-98 **** ******** ******** ******** ********
21 03-Aug-98 **** ******** ******** ******** ********
22 10-Aug-98 **** ******** ******** ******** ********
23 17-Aug-98 **** ******** ******** ******** ********
24 24-Aug-98 **** ******** ******** ******** ********
25 31-Aug-98 **** ******** ******** ******** ********
26 07-Aug-98 **** ******** ******** ******** ********
27 14-Sep-98 **** ******** ******** ******** ********
28 21-Sep-98 **** ******** ******** ******** ********
29 25-Sep-98 **** ******** ******** ******** ********
30 05-Oct-98 **** ******** ******** ******** ********
31 12-Oct-98 **** ******** ******** ******** ********
32 19-Oct-98 **** ******** ******** ******** ********
33 26-Oct-98 **** ******** ******** ******** ********
34 02-Nov-98 **** ******** ******** ******** ********
35 09-Nov-98 **** ******** ******** ******** ********
36 16-Nov-98 **** ******** ******** ******** ********
37 23-Nov-98 **** ******** ******** ******** ********
38 30-Nov-98 **** ******** ******** ******** ********
39 07-Dec-98 **** ******** ******** ******** ********
Assumption: ******** for VITEX QA release and ********
10/15/97 ******** ******** 2 of 2
91
SCHEDULE 3.11
TESTING
-------
92
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
M E M O R A N D U M
V I T E X
---------
TO Xxxxxx Xxxxxxx
FROM: Xxxxx Xxxxxx
DATE: October 29, 1997
RE: ARC Testing of SD Plasma
--------------------------------------------------------------------------------
As per your request of 10/28: the testing we would like the ARC labs (preferably
the National Testing Laboratory in Philadelphia) to perform on each lot of SD
Plasma is for ****************************************************************
We would probably send the samples once a week by overnight express *****
************************************************** Testing should be completed
by ARC within **** calendar days of receipt, with the results to be faxed to
Vitex on or before the ****. The hard copy of the results should also be
mailed out by the ****. Fax results to the attention of Xx. Xxxxx Xxxxxx at
000-000-0000. Note: the contract should also reserve the right for Vitex to
conduct periodic GMI compliance audits of the testing laboratory (FDA requires
this).
If necessary, we could send the samples out more frequently than once per week
but this would needlessly increase our shipping costs without any concomitant
decrease in release time.
Please let me know if you have any additional questions or need any additional
information.
93
SCHEDULE 3.3
ANRC MARKETING EXPENSES PROPOSAL
--------------------------------
94
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
SCHEDULE 3.3
ANRC MARKETING EXPENSES PROPOSAL
--------------------------------
The ANRC agrees to contribute and budget expenses for direct marketing,
direct selling, promotional, educational, advertising and similar activities, as
follows and subject to conditions outlined below:
******** months) - **********
********** months) - **********
Conditions
----------
VITEX continues to meet minimum supply requirements.
The ANRC budget will not include fixed overhead (e.g. fixed personnel
expenses) travel and entertainment expends (except as part of a project or
event specific targeted to a customer audience), marketing research, or
advertising agency retainer fees.
All moneys spent for the express marketing of the Product.
VITEX contributions not allocable to the ANRC direct sales force selling
time expense.
Up to ********** of the ANRC contribution to marketing may be allocated to
sales force expense.
95
SCHEDULE 4.5
VITEX MARKETING EXPENSES PROPOSAL
---------------------------------
96
["****" 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
---------------------------------
VITEX agrees to contribute to and budget for direct marketing expenses for the
Product as follows and subject to the conditions outlined below:
**** months ****= **********
**** months ****= **********
Conditions:
----------
The ANRC continues to meet minimum purchase requirements
VITEX budget will not include fixed overheads (e.g. personnel expenses),
travel and entertainment expenses (except as part of a project or event
expense for agreed upon target audience), market research, or advertising
agency retainer fees.
All monies spent for the express benefit of the Product Proprietary
Technology.
VITEX contributions not allocable to ANRC direct sales force selling time
expense.
97
SCHEDULE 5.8
RECORDS AND REPORTS
-------------------
98
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.
99
SCHEDULE 6.3
INSURANCE COVERAGE
------------------
100
["****" 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
101
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
aforementioned VITEX 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.
102