STRATEGIC SUPPLY AGREEMENT
STRATEGIC
SUPPLY AGREEMENT
This
Strategic Supply Agreement (this “Agreement”)
is
entered into as of the 3rd
day of
April, 2008 (the “Effective
Date”),
by
and between Lev Pharmaceuticals, Inc., a Delaware corporation (the “Buyer”)
and
Plasma Centers of America, LLC, a Nevada limited liability company
(“Seller”).
Buyer
and Seller are referred to collectively herein as the “Parties.”
RECITALS
WHEREAS,
Seller
owns and operates plasma collection centers at various sites throughout the
United States and is willing, on the terms and conditions described herein,
to
construct and operate three additional plasma collection centers (the
“New
Centers”);
and
WHEREAS,
in
accordance with and subject to the terms and conditions of this Agreement,
including the Seller’s achievements of the operating targets for the New
Centers, Buyer desires to purchase from the Seller the New Centers and such
related assets, properties and rights described herein and the Seller desires
to
sell such assets, properties and rights, all on the terms and conditions set
forth herein.
NOW,
THEREFORE,
in
consideration of the premises and the mutual promises herein made, and in
consideration of the representations, warranties, and covenants herein
contained, the Parties agree as follows.
Section
1. Certain
Definitions.
“Affiliate”
shall
mean any subsidiary, parent company, or other legal entity that directly or
indirectly controls, is controlled by, or is under common control with or of
a
Party. For purposes of this definition, “control” means the direct or indirect
ownership of more than fifty percent (50%) of the profits or earnings of the
legal entity, or the right or power to direct the policy decisions of the legal
entity.
“Applicable
Laws”
shall
mean all applicable federal, state, local and foreign laws, requirements,
regulations, guidelines, licenses and directives, including applicable current
Good Manufacturing Practices (“cGMPS”),
including all specifications and procedures for plasma sourcing, plasma testing,
and in process testing and all regulations, specifications, and procedures
contained therein, including without limitation, all applicable U.S. FDA laws,
requirements, regulations, guidelines, licenses and directives, including
applicable cGMPs and the FD&C Act.
“Foreign
Regulatory Approvals”
shall
mean all necessary regulatory approvals and permits for the operation of a
Plasma collection facility pursuant any treaties, statues, regulations and
other
requirements applicable in the European Union or any member country of the
European Union.
“Material
Adverse Effect”
shall
mean any effect or change that would be materially adverse to the business,
assets, condition (financial or otherwise), operating results, or operations,
of
the New Centers and Seller, taken as a whole, or to the ability of any Party
to
consummate timely the transactions contemplated hereby.
“Plasma”
shall
mean “Source Plasma” as defined by the United States Food and Drug
Administration (“FDA”)
in 21
C.F.R. 640.60 that meets the definitions and specifications of Buyer set forth
in Schedule
1
(the
“Specifications”),
attached hereto and incorporated by reference herein.
“Qualified
Center”
shall
mean a New Center (defined above) that has satisfied the Operating Benchmarks
(defined below) within the required timeframes.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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1
“Regulatory
Approvals”
shall
mean all necessary regulatory approvals and permits for the operation of a
Plasma collection facility, including FDA licensure, IQPP certification, CLIA
and required state licensing.
Section
2. General
Terms and Obligations
2.1 Construction
of New Centers.
Pursuant
to the terms and conditions of this Agreement, Seller shall design, construct
and operate the three New Centers. The locations and construction schedule
for
each of the New Centers shall be as mutually agreed upon by the Parties by
action of the Management Committee; provided, however that the Parties hereby
agree that the schedule for the construction and completion of the New Centers
shall be as set forth on Exhibit
A
to this
Agreement.
2.2 Management
Committee.
(a) There
shall be a management committee (the “Management
Committee”)
comprised of a total of three (3) representatives to be appointed by Buyer
and
Seller and established within 30 days of the Effective Date. The Parties shall
notify each other in writing of its selection of persons to serve as its
representatives on the Management Committee within ten business days from the
Effective Date. The Management Committee shall be comprised at all times of
an
odd number of individuals and the Buyer shall have the right to appoint a
majority of the members of the Management Committee. If, however, the Management
Committee must be constituted with a majority of representatives of Seller,
then
Management Committee action shall require the consent of all Buyer
representatives. One of Buyer’s representatives shall act as the Chairman of the
Management Committee.
(b) The
purpose of the Management Committee shall be to oversee the site selection,
construction and operation of the New Centers prior to acquisition by Buyer,
including without limitation the establishment of an automated donor management
system to be used in the New Centers. Within ninety (90) days of the Effective
Date, the Management Committee shall identify the geographic locations of each
of the three New Centers contemplated by this Agreement and agree in writing
as
to the identity of each of the three New Centers. The maximum number of New
Centers covered by this Agreement shall be the three New Centers agreed upon
as
the New Centers by the Management Committee and absent an express written
agreement between the Parties, neither Party shall have the right to add an
additional New Center to the scope of this Agreement in order to replace a
New
Center that fails to be deemed a Qualified Center for which a Party elects
not
to require the sale or purchase of a Qualified Center. Through its
representatives on the Management Committee, Buyer shall approve, for all New
Centers, all lease terms, facility designs, construction schedules, hiring
of
management staff, and an automated donor management system to be implemented
in
each New Center. The Parties however agree that the facility design of the
New
Centers will be substantially similar to the collection centers currently owned
and operated by Seller from which Buyer has purchased Plasma from Seller
pursuant to arrangements or agreements independent of this Agreement.
Notwithstanding the foregoing, the Management Committee shall have the authority
to require particular specifications for the New Centers, in its sole
discretion. The Management Committee will have the authority to approve any
modifications to the construction schedule set forth on Exhibit
A
and
shall certify when the targets incorporated into the construction schedule
for
each New Center has been satisfied. As used herein the target dates by which
each New Center shall commence business operations may be referred to as the
“New
Center Opening Dates”.
The
Parties hereby agree that in the event that one or two of the New Centers are
not opened for business within the time periods established therefore by the
Management Committee, then unless otherwise agreed to by Buyer, the Buyer’s
obligations hereunder to (A) purchase Plasma (or Pre-Licensed Plasma) from
such
New Center(s) and (B) acquire such New Center(s) shall immediately terminate
upon Buyer’s written notice. The failure of the Seller to timely secure the
opening of all New Centers by the New Center Opening Dates specified on
Exhibit
A
shall be
grounds for termination of this Agreement pursuant to Section
9.4.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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2.3 Operation
of the New Centers.
Seller
shall operate the New Centers in accordance with industry norms, including
without limitation, those standards relative to employee/staff compensation
and
payment of donor fees. In addition, Seller shall comply with the operating
covenants for the New Centers specified in this Agreement. The New Centers
shall
be constructed and operated in a manner that is compliant with all Regulatory
Approvals, including Foreign Regulatory Approvals and qualify for approval
by
the relevant regulatory authorities in the United State and the European
Union.
2.4 Operating
Benchmarks.
As
described throughout this Agreement, certain of Buyer’s obligations are
conditioned upon the satisfaction by Seller of certain operating benchmarks.
The
Parties hereby agree that the operating benchmarks shall be defined as follows
(the “Operating
Benchmarks”):
(a)
Seller
shall secure all Regulatory Approvals for each New Center within *
* *
months
from the New Center Opening Date established by the Management Committee for
each New Center; and
(b)
Seller
shall achieve and maintain an average collection level of at least *
* *
plasma
units per *
* *
for a
period of *
* *
(the
“Minimum
Collections”)
for
each New Center during the *
* *
period
commencing on the New Center Opening Date established by the Management
Committee for each New Center.
2.5 Acquisition
of New Centers.
(a) In
the
event Seller achieves all of the Operating Benchmarks described in Section
2.4
for a
New Center, Buyer agrees to purchase or authorize a subsidiary to purchase,
each
such Qualified Center(s) from Seller upon Seller’s request, in accordance with
the terms of this Agreement and an asset purchase agreement to be negotiated
and
executed by the Seller and either Buyer or the Buyer subsidiary. Notwithstanding
the foregoing, Seller’s right and Buyer’s obligation pursuant to this
Section
2.5(a)
shall
expire in the event Seller fails to notify Buyer in writing of its request
to
proceed with the acquisition prior to the first to occur of (i) the date that
is
*
* *
from
each New Center Opening Date or (ii) the date that is *
* *
from the
close of any period of *
* *
during
which the *
* *
period
was *
* *
(the
foregoing timeframe may be referred to herein as the “Required
Acquisition Period”).
(b) Notwithstanding
the foregoing, however, in the event the Operating Benchmarks are achieved
for
one or more New Centers and Seller elects not to cause Buyer to proceed with
the
acquisition of such Qualified Center prior to the expiration of the Required
Acquisition Period (as contemplated by Section
2.5(a)),
Buyer
shall have the right, exercisable within 30 days of the expiration of the
Required Acquisition Period, to cause Seller to proceed with the transaction
to
sell any such Qualified Center to Buyer on the terms and conditions set forth
herein
(c) In
the
event the Operating Benchmarks are achieved for one or more New Centers and
neither Party exercises any of its rights hereunder to proceed with an
acquisition of a Qualified Center, each such New Center shall no longer be
subject to the terms and conditions of this Agreement and neither Party shall
have the further right to require the sale of such New Center. In such an event,
the Parties may elect to continue sales of Plasma from such New Center pursuant
to this Agreement, but shall be under no further obligation to do so absent
a
further written agreement between the Parties.
(d) In
the
event a Party exercises its rights under this Section
2.5
with
respect to one or more Qualified Centers, the Parties will act in good faith
and
use their best efforts to negotiate and execute a definitive asset purchase
agreement for such New Center(s) and to promptly satisfy any and all closing
conditions agreed upon in such asset purchase agreement within the time periods
specified in Section
5.3(a).
The
terms and conditions for the closing of such purchases shall be as defined
in
the definitive asset purchase agreement executed by the Parties. An election
by
a Party not to require the sale or purchase of a Qualified Center shall not
affect the Parties’ rights and obligations hereunder with respect to the other
New Centers covered by this Agreement.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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(e) In
the
event that the Operating Benchmarks are not achieved within the time frames
provided for in Section
2.4
for one
or more (but less than all) of the New Centers, then Buyer shall have no
obligation to purchase the New Center(s) for which the Operating Benchmarks
were
not achieved. In such an event, Buyer agrees to notify Seller of its election
not to acquire such a New Center within forty-five (45) days from the date
Buyer
determines that the New Center(s) did not satisfy the Operating Benchmarks.
The
failure, however, of Buyer to timely notify Seller of such a determination,
however, shall not be deemed an election by the Buyer to proceed with an
acquisition of any such non-qualifying New Center or a waiver by Buyer of any
of
its rights hereunder, including without limitation, the right not to purchase
any New Center that has not satisfied all Operating Benchmarks.
(f) In
addition, in the event that the Operating Benchmarks are not achieved within
the
time frames provided for in Section
2.4
for a
New Center, then (i) in addition to any other rights and remedies that Buyer
shall have pursuant to this Agreement, Buyer shall also have the right to
acquire such New Center for a total purchase price as set forth in Section
5.4(b)
and (ii)
Seller shall immediately transfer and assign to Buyer all standard operating
procedures necessary to operate such New Center for no additional cost. In
the
event Buyer elects to exercise its right to acquire a New Center for which
the
Operating Benchmarks are not achieved (such New Center being referred to herein
as a “Non-Qualified
Center”),
Buyer
shall so notify Seller within forty-five (45) days from the date Buyer
determines that the New Center(s) did not satisfy the Operating Benchmarks
and
the Parties shall act in good faith and use their best efforts to negotiate
and
execute a definitive asset purchase agreement for such Non-Qualified Center
and
to timely satisfy any and all closing conditions agreed upon in such agreement.
The timing for an acquisition of a Non-Qualified Center shall be as set forth
in
Section
5.3(b).
Section
3. Financial
Matters
3.1 Obligations
of Seller. At
all
times prior to acquisition of the New Centers by Buyer, Seller shall be solely
responsible for all costs, fees and expenses associated with the cost of
construction and operation of the New Centers, subject to the payments which
Buyer may make pursuant to this Section
3
of this
Agreement.
3.2 Buyer
Milestone Payments. Buyer
hereby agrees to make the following payments to Seller upon Seller’s achievement
of the performance targets described herein (the payments set forth below may
be
referred to herein as the “Performance
Payments”):
(a) For
each
New Center, Buyer shall pay to Seller a payment of *
* *
upon the
execution of a facility lease within the time period established for such action
by the Management Committee;
(b) for
each
New Center, Buyer shall pay to Seller an amount of *
* *
upon the
issuance of all necessary construction permits for each New Center, within
the
time period established for such action by the Management Committee;
(c) for
each
New Center, Buyer shall pay to Seller a payment of *
* *
upon the
completion of construction of such New Center, as certified by Buyer, within
the
time period established for such action by the Management Committee;
and
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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(d) for
each
New Center, Buyer shall pay to Seller an amount of *
* *
upon
Buyer’s certification that such New Center has actually commenced receiving
donations of Plasma within the time period established for such action by the
Management Committee.
3.3 Purchase
Price of Plasma Sales.
(a) The
purchase price of the Plasma purchased by Buyer from each New Center pursuant
to
Section
4
of this
Agreement shall be *
* *
.
Commencing on the first to occur of (i) the date that is twelve months from
each
New Center Opening Date or (ii) the date that such New Center receives all
Regulatory Approvals, the purchase price of the Plasma from such New Center
shall be increased by the Consumer Price Index (CPI) as reported by the United
States Department of Labor, Bureau of Labor Statistics for the twelve month
period ending October 31, 2008.
(b) During
the period commencing on the New Center Opening Dates and until the date that
such New Center is issued all necessary Regulatory Approvals, the purchase
price
of the Plasma purchased hereunder, which shall be deemed Pre-licensed Plasma
(as
defined in Section
4.2),
shall
be *
* *
of the
per unit purchase price of the Plasma drawn at each New Center as specified
in
Section
3.3(a).
At such
time as Seller fulfills its requirement to obtain all Regulatory Approvals
for
the New Centers and the Pre-licensed Plasma may be released from holding in
accordance with Section
4.3,
Seller
may render invoices to Buyer relating to shipments of such Pre-licensed Plasma
in an amount equal to *
* *
of the
purchase price specified in Section
3.3(a)
for the
quantities of Pre-licensed Plasma shipped to holding. Buyer shall pay the
undisputed invoices for the amounts contemplated in this Section
3.3(b)
in
accordance with the provisions of Section
3.3(c)
of this
Agreement.
(c) Seller
shall invoice Buyer for all Pre-licensed Plasma (defined in Section
4.2
below)
on a bi-weekly basis. Buyer shall pay undisputed invoices within fifteen days
of
receipt of each invoice. Such invoice shall not be dated or submitted prior
to
delivery of the underlying Plasma. All Payments shall be made in U.S. Dollars.
Seller’s invoices shall reflect the actual quantity of the Plasma shipped and
the price thereof, as computed in accordance with this Agreement.
(d) In
the
event Seller is obligated by any regulatory body or agency or otherwise
requested or compelled by Buyer at any time during the term of this Agreement
to
perform or implement any new testing or other quality procedure not specifically
contemplated hereunder, the price then in effect under this Agreement shall
automatically and concurrently be proportionately increased to reflect all
of
Seller’s corresponding additional costs, evidence of which shall be provided to
Buyer upon request. Correspondingly, in the event that Buyer at any time during
the term of this Agreement reduces or eliminates any testing or other quality
procedure so as to result in an actual material decrease in Seller’s incurred
costs to procure, store, provide or supply the Plasma hereunder to Buyer, the
price then in effect under this Agreement shall be proportionately decreased
to
reflect all of Seller’s corresponding savings.
3.4 Termination
of Obligations Regarding a New Center.
(a) In
the
event that both Seller and/or Buyer decline to require the sale and purchase
of
a New Center (including a Qualified Center) in accordance with the terms of
this
Agreement, Buyer’s obligation to purchase, and Seller’s obligation to sell,
Plasma or Pre-Licensed Plasma (defined in Section
4.2
below)
generated from such New Center and Buyer’s obligation to acquire such New Center
shall terminate effective on the date that Buyer notifies Seller of its
determination not to acquire such New Center. Effective as of such date, the
operations of such New Center shall no longer be deemed to be subject to this
Agreement or the oversight of the Management Committee.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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(b) All
Performance Payments for a particular New Center and, to the extent applicable,
all payments for Pre-Licensed Plasma (defined in Section
4.2
below)
collected at a particular New Center made by Buyer shall be reimbursed in full
by Seller in the event that the Buyer’s obligation to acquire such New Center is
terminated due to the non-performance of Seller of any of its obligations
hereunder, in the event the Operating Benchmarks for such New Center are not
timely achieved or in the event Seller elects not to sell a Qualified Center
pursuant to Section
2.5(a)
and
thereafter Buyer elects not to require the sale of such Qualified Center
pursuant to Section
2.5(b).
Reimbursement of such amounts shall be due in full within fifteen days of
Buyer’s request for such payment. Late payments of these amounts shall accrue
interest at the rate of 16% per annum until paid in full by Seller.
Section
4. Purchase
and Sale of Plasma
4.1 Purchases.
From
time to time during the period commencing on each New Center Opening Date and
until the first to occur of (i) the twelve month anniversary of such New Center
Opening Date; (ii) the closing date of the Buyer’s acquisition of such New
Center; (iii) the date of determination by Buyer not to acquire a Non-Qualified
Center; or (iv) the election by the Parties not to sell a Qualified Center
pursuant to Section
2.5
(the
“Purchase
Period”),
Buyer
shall deliver to Seller a purchase order reflecting the aggregate volume of
Plasma to be purchased at such time in accordance with the terms of this
Agreement (a “Purchase
Order”).
Each
Purchase Order shall specify the quantity of Plasma ordered and the delivery
dates. All Plasma shall be deliverable in such increments as Seller and Buyer
may from time to time agree regarding the frequency and schedule for pick-up
and
delivery. Seller agrees to use it best efforts to timely deliver the quantities
of Plasma as agreed hereunder throughout the duration of the Purchase Period.
Subject to the terms and conditions of this Agreement, commencing on the New
Center Opening Dates and continuing through the end of the Purchase Period,
Seller shall sell, and Buyer shall purchase, all of the Plasma collected at
each
of the New Centers for the purchase price specified in Section
3.3,
above.
During such Purchase Period, the Plasma collected at each New Center shall
be
sold exclusively the Buyer.
4.2 Pre-License Purchases.
The
Parties acknowledge that the purchases of Plasma hereunder shall be deemed
“Pre-Licensed
Plasma”
until
such time as the Seller obtains all Regulatory Approvals for the New Centers.
Once Seller obtains the Regulatory Approvals the Pre-Licensed Plasma conforms
to
the Specifications, it shall be deemed to be Plasma. Buyer shall only be
obligated to purchase Pre-Licensed Plasma from Seller pursuant to this Agreement
for a period of 12 months following each New Center Opening Date. In the event
that Seller does not obtain all Regulatory Approvals for a New Center within
the
foregoing time period, Buyer shall have the right, upon written notice, to
immediately terminate its obligation to purchase Pre-Licensed Plasma from such
New Center and Seller shall reimburse Buyer for all amounts paid by Buyer for
such Pre-Licensed Plasma within fifteen days of Buyer’s notice.
4.3 Delivery.
Except
as otherwise agreed in writing by the Parties, all deliveries of Plasma shall
be
FOB New Center(s) or other facility designated by Seller reasonably acceptable
to Buyer. The shipping agent or carrier shall be selected and contracted by
Buyer. Shipments of Pre-Licensed Plasma shall be made from the New Centers
to a
“holding” location to be specified in writing by Buyer. Pre-Licensed Plasma
shipped to holding shall be stored and handled in fully compliance with all
Applicable Laws. Title to the Plasma and risk of loss shall pass from Seller
to
Buyer when the Plasma is provided to or placed with Buyer’s shipping agent or on
a transport carrier. Title to Pre-Licensed Plasma and risk of loss shall pass
from Seller to Buyer when the Pre-Licensed Plasma is deemed to be Plasma in
accordance with the terms and conditions of this Agreement. The Seller will
be
responsible for all storage charges at the holding facility until all Regulatory
Approvals have been received for the New Center and the Pre-Licensed Plasma
is
subsequently released to the Buyer’s account.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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4.4 Governing
Documents.
All
sales of Plasma hereunder shall be subject solely to the terms and provisions
of
this Agreement (including all exhibits and schedules) and shall not be subject
to other terms, conditions or provisions contained in any other purchase order,
writings, or documents except to the extent a purchase order, writing or
document sets forth or confirms quantity or schedule for delivery. Furthermore,
in the event of any inconsistency or discrepancy between the terms and
conditions of this Agreement and the schedules hereto, or any other record,
the
terms of this Agreement shall prevail.
4.5 Records
and Compliance Matters.
Seller
shall, at its expense, keep and maintain detailed records pertaining to the
amount and type of Plasma (including Pre-Licensed Plasma) sold hereunder during
the term of this Agreement and for a period of 30 years following the date
of
termination or expiration of the Agreement. Seller shall transfer such records
in connection with the consummation of the acquisition of the New Centers,
as
contemplated by this Agreement. Such records shall be made available for
inspection by Buyer during normal business hours, upon reasonable advance
notice. Inspections by Buyer pursuant to this clause shall be subject to the
other terms and conditions pertaining to inspections set forth in Section
14.1.
4.6 Permits
and Approvals.
Each
Party shall obtain all necessary licenses, permits, certificates of origin
and
other requisite documents, including approvals and registrations, and pay all
applicable fees, charges, customs duties and taxes incurred in the performance
of its obligations under this Agreement. Both Parties shall comply with all
Applicable Laws, regulations rules, and guidelines pertaining to their
performances under this Agreement, including but not limited to those set forth
in the U.S. Code of Federal Regulations, 21 C.F.R. parts 600-640 and any other
applicable local, state or federal law, regulation or ordinance within the
United States.
4.7 Storage
and Handling of Plasma. Plasma
and Pre-Licensed Plasma shall be stored, handled, packed and shipped by Seller
in such a manner as to prevent damage to the Plasma, Pre-Licensed Plasma or
containers during shipping and in compliance with all Applicable Laws and shall
be shipped (including to any holding facility designated by Buyer) subject
to
such other conditions set forth in the Specifications, and any other written
instructions provided by Buyer. No Plasma shall be released pursuant to this
Agreement unless and until such Plasma fully complies with the Specifications
and Applicable Laws and Seller shall be responsible for ensuring compliance
with
all such Specifications.
4.8 New
Center Supply.
Seller
will supply and Buyer shall accept Plasma or Pre-Licensed Plasma from New
Centers only. In the event that a New Center is found by Buyer to be materially
deficient in its compliance with the applicable procedures or Regulatory
Approvals (including Foreign Regulatory Approvals), Seller shall have fifteen
(15) days to provide, in writing, a corrective action plan acceptable to Buyer
in Buyer’s reasonable discretion. If the action plan is unacceptable or if the
subject plasma New Center cannot cure the deficiency to Buyer’s satisfaction and
lawfully provide Plasma within sixty (60) days of any such event, then, at
Buyer’s option said New Center may be eliminated from this Agreement in all
respects.
4.9 Buyer
Approved Testing Center.
Buyer
and Seller shall agree (within 30 days of the execution of this Agreement)
upon
the identity of the vendors to perform viral marker and NAT testing of Plasma
and Pre-Licensed Plasma (each an “Approved
Testing Center”),
and
Seller agrees to send any Plasma and Pre-Licensed Plasma provided to Buyer
pursuant to this Agreement only to Approved Testing Centers.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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4.10 Quality.
Seller
shall manufacture, process, store, distribute, test, transport, dispose and
otherwise handle Plasma (and Pre-Licensed Plasma) at all times in compliance
with all Applicable Laws and the Specifications set forth in Schedule
1.
Any and
all changes sought by Buyer to the initial Specifications set forth in
Schedule
1
to this
Agreement shall be sent to Seller for review and approval. Buyer shall advise
Seller of any and all anticipated changes to specifications as soon as
practicable so as to provide Seller with as much advance notice as possible.
Seller shall have fifteen (15) business days to agree to implement such changes.
Process cost increases resulting from Specification changes requested by Buyer
or necessitated or advisable in response to regulatory action (or threat
thereof) shall be borne by Buyer (other than any such changes requested to
respond to any action or threat thereof by any regulatory agency related to
the
operation of a New Center in a manner consistent with the procedures that Seller
operates other Plasma collection centers, which costs shall be borne by Seller).
If any New Center is closed as a result of regulatory sanctions placed on Seller
by the FDA or equivalent foreign regulatory body, or if Seller or any New Center
receives a warning letter or consent decree from the FDA or equivalent
regulatory body or any accrediting body, or is otherwise subject to similar
quality concerns, Seller must notify Buyer immediately and in any event not
later that five (5) business after the earlier of Seller’s receipt of the
relevant communication or the date it learns of such quality concern. Seller
shall not make changes to the key process parameters that require prior approval
from the FDA or the specifications without prior reasonable notice to Buyer,
which prior notice shall be at least six (6) months unless otherwise required
by
a regulatory body.
4.11 Testing
and Approval.
With
respect to each shipment of Plasma (and Pre-Licensed Plasma) to be shipped
to
Buyer, Seller shall test such Plasma (and Pre-Licensed Plasma) to ensure
compliance with the Specifications. Seller shall include a certificate of
analysis (“COA”)
as
well as all other documentation described in the Specifications with each
shipment of Plasma disclosing the results of such testing and showing
conformance with the specifications. Subject to the existence of any latent
defects, Buyer shall have a period of thirty (30) days from date of its receipt
of a shipment of Plasma to inspect the delivered Plasma and the accompanying
COA
and reject all or part of the corresponding shipment of Plasma for nonconformity
with the specifications. If Buyer rejects all or part of such shipment, it
shall
promptly notify Seller and the provisions of Section
4.12
below
shall apply. If after accepting a shipment of Plasma, Buyer subsequently
discovers latent material defects (including without limitation, nonconformance
to the specifications) not reasonably discoverable during the acceptance period
set forth above, Buyer may revoke its acceptance of such shipment of Plasma
by
giving written notice and disclosing the nature of any defects to Seller as
soon
as practicable after discovering such defects. In such event, such Plasma shall
be considered to be nonconforming to the extent latent material defects in
fact
are present and the provisions of Section
4.12
below
shall apply.
4.12 Remedies.
If a
shipment of any Plasma (and Pre-Licensed Plasma) or any portion thereof fails
to
conform to the Specifications or Applicable Laws or is otherwise not as
warranted or contains latent defects, or that has not been manufactured,
processed, stored, distributed, tested, transported, disposed of or otherwise
handled in accordance with Applicable Laws or the specifications, then Buyer
shall have the right to reject such non-conforming shipment or portion thereof.
Buyer shall give written notice to Seller of its rejection hereunder, setting
forth in detail the basis of the rejection, within forty-five (45) days after
receipt, specifying the grounds for such rejection. The nonconforming shipment
or portion thereof shall be held for Seller’s disposition, or shall be returned
to Seller, or destroyed if required by Applicable Law, in each case at Seller’s
expense, as directed by Seller. Buyer shall not be obligated to buy or pay
for
any shipment which does not comply with the specifications or Applicable Laws,
or is otherwise not as warranted. Buyer shall receive a full credit for any
rejected shipment, which shall include Buyer’s shipping costs. At Buyer’s
option, Seller shall at no cost to Buyer, cause within thirty (30) days of
Buyer’s notice, an equivalent amount of conforming Plasma to be delivered to
Buyer.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
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Section
5. Purchase
of New Centers
5.1 Acquisition.
In the
event Seller achieves all of the Operating Benchmarks described in Section
2.4
for each
New Center and either Seller or Buyer exercise their rights under Section
2.5
to
require a sale and purchase of such Qualified Center(s) in accordance with
the
terms of this Agreement and an asset purchase agreement (the “New
Center Purchase Agreement”)
to be
negotiated and executed by the appropriate parties, then with respect to each
Qualified Center, the Parties will act in good faith and use their best efforts
to negotiate and execute the New Center Purchase Agreement for such Qualified
Center(s) and to promptly satisfy any and all closing conditions agreed upon
in
such New Center Purchase Agreement. The terms and conditions for the closing
of
such transactions shall be as defined in the New Center Purchase Agreement
executed by the appropriate parties. In the event that all of the Operating
Benchmarks are not achieved within the time frames provided for in Section
2.4
for a
New Center, Buyer shall have no obligation to purchase any Non-Qualified Center.
Buyer, however, may exercise its right under Section
2.5(f)
to
acquire such a Non-Qualified Center. In such event, the obligations of the
Parties described in this Section
5.1
shall be
applicable to an acquisition of a Non-Qualified Center.
5.2 New
Center Purchase Agreement.
The
obligation of Buyer to acquire any New Center (whether a Qualified or a
Non-Qualified Center) is subject in all respect to the terms of the definitive
New Center Purchase Agreement to be negotiated, drafted, executed and exchanged.
The New Center Purchase Agreement will describe the specific assets to be
purchased and/or assigned and the liabilities to be assumed and any other rights
and obligations of the parties arising out of such transactions. The Parties
agree to commence negotiations toward the definitive New Center Purchase
Agreements during the construction phase under this Agreement and to act in
good
faith to agree upon the final form of New Center Purchase Agreement in a timely
manner. The mere failure of the Parties to have agreed upon the final form
of
New Center Purchase Agreement prior to any particular target date, absent a
written agreement to the contrary, shall not be deemed a breach of this
Agreement absent the bad faith of a Party.
5.3 Timing
of Acquisitions.
(a) Acquisitions
of Qualified Centers. For
each
New Center that is deemed to be a Qualified Center, the Parties will act in
good
faith and use their best efforts to consummate the acquisition of such Qualified
Center(s) within *
* *
from the
date that Seller or Buyer, as the case may be, exercises its right under
Section
2.5,
to
require a sale and purchase of a Qualified Center. In the event that the Parties
are not able to consummate an acquisition of a Qualified Center during the
foregoing time period, either Party may notify the other Party that it considers
such other Party to be in default of its obligations under this Agreement and
provide such Party with a period of 30 days within which to cure such default.
In the event the Parties are not able to consummate such transaction within
such
additional 30 day period, such failure may be deemed grounds for termination
of
this Agreement and in such an event, the provisions of Sections
9.4 and 9.5
shall
apply. Furthermore, in the event the Parties fail to consummate a timely sale
of
a Qualified Center, thereafter, the Parties may, but shall have no obligation
to, agree that Seller shall no longer be subject to the exclusivity conditions
of this Agreement solely with respect to the Qualified Center for which an
acquisition was not consummated and the obligations of the Parties with respect
to purchases and sales of Plasma from such Qualified Center shall be as set
forth in Section
2.5(c).
(b) Acquisitions
of Non-Qualified Centers. For
any
New Center that Buyer that is a Non-Qualified Center which Buyer elects to
acquire in accordance with Section
2.5(f),
the
Parties will act in good faith and use their best efforts to consummate the
acquisition of such Non-Qualified Center(s) within *
* *
from the
date that Buyer exercises its right under Section
2.5(f),
to
require a sale and purchase of a Non-Qualified Center. In the event that the
Parties are not able to consummate an acquisition of a Non-Qualified Center
during the foregoing time period, Buyer may notify the Seller that it considers
Seller to be in default of its obligations under this Agreement and provide
Seller with a period of 30 days within which to cure such default. In the event
the Parties are not able to consummate such transaction within such additional
30 day period, such failure may be deemed grounds for termination of this
Agreement and in such an event, the provisions of Sections
9.4 and 9.5
shall
apply. Furthermore, in the event the Parties fail to consummate a timely sale
of
a Non-Qualified Center, thereafter, the Parties may, but shall have no
obligation to, agree that Seller shall no longer be subject to the exclusivity
conditions of this Agreement solely with respect to the Non-Qualified Center
for
which an acquisition was not consummated and the obligations of the Parties
with
respect to purchases and sales of Plasma from such Non-Qualified Center shall
be
as set forth in Section
2.5(c).
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
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5.4 Acquisition
Cost of New Centers.
(a) Qualified
Centers. The
purchase price for each Qualified Center to be purchased shall be equal to
the
most recent *
* *
for such
Qualified Center, *
* *
and
multiplied by *
* *
per
liter, less all *
* *
made by
Buyer. However, in addition to this acquisition cost, Buyer agrees that that
its
cost to acquire (i) cash on hand and current inventory of medical supplies
will
be equal to *
* *
,
subject to a maximum amount of *
* *
and (ii)
Seller’s current inventory of Plasma at such Qualified Center shall be upon the
*
* *
set
forth in this Agreement.
(b) Non-Qualified
Centers. The
purchase price for any Non-Qualified Center to be purchased shall be equal
to
*
* *
of the
purchase price that Buyer would pay pursuant to Section
5.4(a)
of this
Agreement if the Non-Qualified Center was a Qualified Center. However, in
addition to this acquisition cost, Buyer agrees that that its cost to acquire
Seller’s current inventory of Plasma at such Non-Qualified Center shall be upon
the *
* *
set
forth in this Agreement.
5.5 New
Center Assets.
(a)
Pursuant
to the New Center Purchase Agreement, Seller shall sell, assign, transfer,
convey and deliver to the Buyer (or Buyer’s subsidiary), and the Buyer (or the
Buyer subsidiary) shall purchase, acquire and accept from the Seller, all of
the
Seller’s right, title and interest in and to the New Centers and the following
assets related to the New Centers, as shall be more specifically expressed
in
the definitive New Center Purchase Agreement (collectively, the “New
Center Assets”):
(i)
those certain parcels of real property (including all buildings, improvements
and structures located thereon and all appurtenances thereto) owned or leased
by
on which the New Centers are situated; (ii) all of the leasehold interests
and
rights of the Seller, including such subleases under the tenant space leases,
ground leases and other leases of real property; (iii) all fixed assets,
fixtures, furnishings, furniture, office supplies, tools, machinery and
equipment owned or leased by the Seller used in the operation of the New
Centers; (iv) all the plasma inventories and related supplies and all
inventories of general production supplies used in the operation of the New
Centers; (v) those approved standard operating procedures, licenses, permits,
contracts, agreements, arrangements and/or commitments listed in the New Center
Purchase Agreement; (vi) all business and financial records and personnel and
donor records relating exclusively to the New Centers; (vii) the Seller’s
proprietary data bases, donor lists and records, donor center technical guides,
quality control and training manuals, specialty guides and standard operating
procedures with respect to the operations of the New Centers; and (viii) all
good will of the Seller related to the New Centers.
(b) The
New
Center Purchase Agreement shall also provide that the Buyer (or Buyer
subsidiary) shall assume and shall thereafter pay, discharge and perform in
the
ordinary course solely those obligations as identified therein as “Assumed
Obligations”. The Buyer (or Buyer subsidiary) shall not assume and shall not be
liable for any liabilities or obligations of the Seller other than as expressly
identified in the New Center Purchase Agreement as an Assumed Obligation. The
Seller shall remain responsible for all liabilities and obligations related
to
the New Centers arising or accrued prior to the closing date of the transactions
contemplated by this Section.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
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COMMISSION.]
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5.6 Exclusivity;
Required Sale of New Centers.
(a)
From
the
Effective date and until the first to occur of (1) the closing of the purchase
of the New Centers or (2) the determination by the Buyer not to proceed with
the
acquisition of the New Centers, Seller will not (i) solicit, initiate, or
encourage the submission of any proposal or offer from any person or entity
relating to the acquisition of any capital stock, membership interests or other
voting securities of Seller, or any assets of Seller directly or indirectly
used
in the New Centers (including any acquisition structured as a merger,
consolidation, exchange or purchase of a controlling interest), or (ii)
participate in any discussions or negotiations regarding, furnish any
information with respect to, assist or participate in, or facilitate in any
other manner any effort or attempt by any person or entity to do or seek any
of
the foregoing without first complying with the provisions of this Section.
This
Section, however, shall not prohibit Seller from engaging in transactions to
sell assets that are not used, directly or indirectly, in the New Centers or
that are not otherwise important to the operations of the New Centers. The
sale
or transfer of an asset other than an asset used in a New Center shall be deemed
to be used in or important to the operations of a New Center if, upon the
consummation of the transaction for the sale or transfer of such assets (or
a
series of such transactions occurring within a period of six consecutive
months), Seller’s operation of any New Center shall be materially and adversely
impacted.
(b) If
during
the period of exclusivity contemplate by Section
5.6(a),
Seller
wishes to enter into any transaction which would result in a change in control
of Seller (a “Proposed
Transaction”),
Buyer
shall have the right (but not the obligation) to acquire the New Centers prior
to the Seller entering into any such agreement relating to a Proposed
Transaction at an acquisition cost based on the price specified in Section
5.4(a)
above,
at the run rate of Plasma collections for the three consecutive months
immediately prior to the date that Seller became aware of such Proposed
Transaction, unless the New Center that is the subject of such a transaction
is
a Non-Qualified Center, in which case the acquisition cost shall be as specified
in Section
5.4(b).
In the
event Buyer declines to exercise the right provided for herein, Seller shall
be
permitted to proceed with the Proposed Transaction, subject in all respects
to
its obligations hereunder and the counterparty to such transaction agreeing
to
perform Seller’s obligations under this Agreement and otherwise abide by the
terms and conditions hereof, inclusive of this Section
5.6.
(c) In
the
event Seller becomes aware of a Proposed Transaction, Seller shall immediately
provide the Buyer with written notice of such potential transaction and in
no
event shall Seller proceed with such Proposed Transaction prior to the
expiration of the time periods described in this Section
5.6.
The
notice contemplated in this Section
5.6(c)
shall
provide at a minimum, (i) the timeframe of the Proposed Transaction; (ii) the
terms of the Proposed Transaction, including the identity of the counterparty
to
such Proposed Transaction; and (iii) the rate of Plasma sales from each New
Center during the three month period ending immediately prior to the date the
notice is sent.
(d)
Buyer
shall have a period of thirty (30) from the date of its receipt of such notice
to notify Seller if it wishes to acquire one or more of the New Centers
(regardless if any New Center is a Qualified Center as of such date) for a
acquisition cost based
on
the price specified in Section
5.6(b).
In the
event Buyer elects to require the sale of one or more New Centers, Buyer and
Seller shall proceed with the transaction in good faith and use their
commercially reasonable efforts to consummate such transaction within sixty
(60)
days from the date Buyer notifies Seller of its election. The terms and
conditions of this Section
5
shall
apply to any transaction subject to this Section
5.6.
In the
event the Parties are unable to consummate such a transaction, such New Centers
will continue to be subject to this Agreement unless otherwise provided for
in
this Agreement.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
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COMMISSION.]
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(e)
In the
event Buyer declines to purchase all New Centers pursuant to this Section
5.6,
Seller
shall be permitted to proceed with the Proposed Transaction. In the event Buyer
elects to purchase one or more, but less than all New Centers, Seller may
proceed with the Proposed Transaction only after consummating the sale of the
New Centers to Buyer. In the event Seller is permitted to proceed with a
Proposed Transaction and is unable to consummate such transaction within sixty
(60) days of the date that Buyer has declined to purchase a New Center, Seller
shall again be subject to the provisions of this Section
5.6
for any
subsequent Proposed Transaction. This Section
5.6
will
survive the closing of any particular Proposed Transaction and remain applicable
to any subsequent Proposed Transaction during the period of exclusivity
specified in Section
5.6(a).
Section
6. Construction
of New Centers
6.1 Description
of Services.
Seller
shall perform or subcontract for all engineering and construction services
(hereinafter referred to as the “Construction
Services”)
for
each of the New Centers. Such Construction Services may include those
specifically set forth and described in a project plan to be negotiated, drafted
and agreed upon by the Parties (the “Project
Plan”).
It is
understood that all Construction Services shall be in accordance with the final
Project Plan as shall be approved by both Parties. The Project Plan shall
include detailed specifications as to the construction and operation of the
New
Centers, including without limitation a detailed budget for the project and
a
timeline for the construction and certification of all New Centers. Commencing
on the Effective Date, the Parties shall use their commercially reasonable
efforts and cooperate in the development of the Project Plan for the
construction of the New Centers and shall jointly agree the final Project Plan
prior to commencement of construction.
6.2 Seller
Responsibilities.
As
required for the Construction Services, Seller shall (unless otherwise provided
herein) subject to the terms and provisions of this Agreement and Project
Plan:
(a)
Furnish supervisors, engineers, designers, draftsmen, and other personnel
necessary for the preparation of drawings and specifications;
(b)
Furnish buyers, inspectors, expediters, and other personnel necessary to procure
specified equipment per the Project Plan;
(c)
Furnish supervisors, foremen, skilled and unskilled labor, and all other
personnel;
(d)
Procure or supply machinery, equipment, materials, expendable construction
items
and supplies, related services and contracts;
(e)
Obtain all Regulatory Approvals;
(f)
Supply the major construction tools and equipment, and where not available,
procure third party construction tools and equipment, and supply small tools;
and
(g)
Allow access to the work areas for personnel of the Buyer and its agents. All
Buyer personnel, agents, contractors and subcontractors shall be required to
follow all Seller safety requirements and training.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
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COMMISSION.]
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(a) Seller
is
and shall operate as an independent contractor in regards to this Agreement
and
not as an agent or employee of Buyer. All Seller’s subcontracts, supply
agreements, and lease and rental agreements entered into pursuant to this
Agreement shall contain a provision expressly stating that no contractual
relationship exists between Buyer and any person, or entity with which Seller
has entered into a purchasing or contracting relationship. To the extent that
Seller places purchase orders with vendors, such purchase orders shall only
be
placed within the parameters previously approved by the Management Committee
or
otherwise with the express written approval of the Management
Committee.
(b) Subject
to the Project Plan and the oversight of the Management Committee, at all times,
Seller shall be solely responsible for the means, methods, sequences, and
procedures for the performance of its work under this Agreement. Seller shall
accept responsibility for its agents, contractors, subcontractors, suppliers,
and all others it hires or engages to perform or assist in performing the work,
whether on or off the project site.
(c) Either
Party may, through its authorized representative, without invalidating this
Agreement, request changes within the general Project Plan required by this
Agreement, by altering, adding to, or deducting from the Services to be
performed (a “Change
Order”).
A
Change Order shall not be binding unless agreed to by both Parties.
(d) Seller
shall commence the Services as agreed after the date of this Agreement and
shall
prosecute the services on a best efforts basis continuously and with due
diligence in accordance with the schedule agreed upon in the Project Plan.
(e) As
soon
as each New Center is in the opinion of Seller mechanically complete and ready
for initial start-up operation, Seller shall so notify the Buyer by means of
a
Construction Completion Report. This report shall state which New Center Seller
proposes to demonstrate (meaning to prove or make evident by reasoning or
adducing evidence) have been mechanically completed in accordance with the
Project Plan and have passed such tests as may have been required of Seller
under the Agreement or the Project Plan. Seller shall propose a program for
such
demonstrations commencing within a reasonably prompt timeframe after the date
of
the notice. Mechanical Completion and the term “mechanically complete” shall
mean that all components of the New Centers have been properly installed in
accordance with applicable drawings and specifications, and the New Centers
are
demonstrated to be ready for reasonable initial startup.
(f) Upon
the
reasonably satisfactory completion of such demonstration, Seller and the Buyer
shall sign the Construction Completion Report, stating that Seller has
demonstrated to the Buyer that the New Center is mechanically complete and
in a
condition such that any procedures needed before the New Center is put into
operation may safely be carried out. Such Construction Completion Report may
include a reasonable punchlist of items requiring completion before the
completion of the Construction Services. Mechanical Completion shall not be
achieved if the punchlist includes substantial items which would hinder the
Buyer from operating in the space or which would be difficult to correct due
to
environmental or other requirements.
Section
7. Operational
Matters Regarding New Centers
7.1
Affirmative
Covenants. With
respect to the operations of the New Centers, the Seller and its subsidiaries
will:
(a)
at
all
times, operate the New Centers in a reasonable and prudent manner in compliance
with all Applicable Laws, its FDA-approved Standard Operating Procedures and
all
other standards generally practiced in the industry and construct and operate
the New Centers in a manner that is compliant with all Regulatory Approvals,
including Foreign Regulatory Approvals, and qualify for approval by the relevant
regulatory authorities in the United State and the European Union. Consistent
with the foregoing, the Seller shall use its reasonable efforts consistent
with
good business practice to preserve the goodwill of the suppliers, contractors,
licensors, employees, customers, distributors and others having business
relations with the Seller.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
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COMMISSION.]
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(b) Pay
and
discharge all lawful taxes, assessments and governmental charges or levies
imposed upon it, upon its income and profits or upon any of its assets, before
the same shall become in default, as well as all lawful claims for labor,
materials and supplies which, if unpaid, might become a lien or charge upon
such
properties or any part thereof, provided, however, that the Seller will not
be
required to pay and discharge any such tax, assessment, charge, levy or claim
so
long as (i) the validity, applicability and/or the amount thereof shall be
contested in good faith by appropriate proceedings, (ii) the Seller, shall
have
set aside on its books adequate reserves in accordance with GAAP with respect
to
any such tax, assessment, charge, levy or claim so contested, and (iii)
enforcement of any lien on any assets of the Seller associated with any such
taxes, assessments, charges, levies or claims shall have been effectively stayed
or fully bonded pending the final determination of any such
proceedings.
(c) Do
or
cause to be done all things necessary to preserve and keep in full force and
affect its corporate existence, rights and franchises and to comply in all
material respects with all laws, regulations and orders of each governmental
authority having jurisdiction over it and the New Centers.
(d) Maintain
executive and management personnel with substantially the same qualifications
and experience as the present executive and management personnel.
(e)
Maintain,
preserve, protect and keep its property, including all New Center Assets, in
good repair, working order and condition and will, from time to time, make
all
necessary and proper repairs, renewals, replacements, betterments and
improvements thereto.
(f) Keep
adequately insured, by financially sound reputable insurers, all New Center
Assets and other property of a character usually insured by similar corporations
and carry such other insurance as is usually carried by similar
corporations.
7.1
Negative
Covenants. The
Seller and its subsidiaries shall not with respect to the New Center and New
Center Assets:
(a) make
any
material change in its operations, except such changes as may be required to
comply with any applicable requirements of law;
(b)
make
any
contract or commitment concerning the New Centers, including with respect to
any
liability or obligation, in excess of $25,000 in the aggregate, except with
the
consent of the Management Committee;
(c)
sell,
lease (as lessor), transfer or otherwise dispose of, or mortgage or pledge,
or
impose or suffer to be imposed any encumbrance on, any of the New Center
Assets;
(d)
institute
any material increase in any profit-sharing, bonus, incentive, deferred
compensation, insurance, pension, retirement, medical, hospital, disability,
welfare or other employee benefit plan with respect to the employees of the
New
Centers, other than in the ordinary course or as required by any such plan
or
requirements of law;
(e)
make
any
general change in the compensation of the employees of the New Centers, other
than changes made in accordance with normal compensation practices;
(f)
sell
or
otherwise transfer any Plasma inventory for the New Centers other than with
the
consent of the Buyer;
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
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COMMISSION.]
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(g)
sell,
transfer or encumber in any manner any New Center or New Center Assets or store
any New Center Assets with any warehouseman or other third party; or
(h) engage
in
any practice, take any action, or enter into any transaction outside the
ordinary course of business. Without limiting the generality of the foregoing,
Seller with respect to the New Centers will not otherwise engage in any
practice, take any action, or enter into any transaction which would cause
a
Material Adverse Change in the New Centers.
Section
8. Warranties
(a) Engineering
and Design Warranty.
Seller
warrants it will perform its engineering and design services (“Engineering
Services”)
in
accordance with the current standards of care and diligence normally practiced
by recognized engineering firms in performing services of a similar nature.
If
during the one (1) year period following acceptance of the Services pursuant
to
Section 8.2
it is
shown that there is an error or omission in the Engineering Services as a result
of Seller failure to meet those standards and Buyer has notified Seller in
writing of any such error within that period, Seller shall reperform such
Engineering Services within the original scope of Services as may be necessary
to remedy such error. All costs incurred by Seller in performing such corrective
engineering and design services shall be to the account of Seller. It is
understood and agreed that time is of the essence with respect to the correction
of any such error or omission. Nothing herein shall remove or limit the Buyer’s
right to make a claim for damages as otherwise provided in the terms and
conditions of this document.
(b) Construction
Warranty.
Seller
warrants it will perform its construction services (“Construction
Services”)
in
accordance with the current standards of care and diligence normally practiced
by recognized construction management firms in performing services of a similar
nature and that such Construction Services shall be free from material defects
in workmanship. If during the one (1) year period following acceptance of the
Services pursuant to Section 8.2
it is
shown that there is an error in the Construction Services as a result of Seller
failure to meet those standards and Buyer has notified Seller in writing of
any
such error within that period, Seller shall re-perform such Construction
Services within the original scope of Services as may be necessary to remedy
such error. All fees and expenses incurred by Seller in performing such
corrective services shall not be paid on such corrective services. It is
understood and agreed that time is of the essence with respect to any such
corrective service. Nothing herein shall remove or limit the Buyer’s right to
make a claim for damages as otherwise provided in the terms and conditions
of
this document.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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8.2 Warranties
of Seller Regarding Operation of New Centers and the Sale of
Plasma
(a) Seller
warrants that the Plasma delivered hereunder shall conform to the Plasma
Specifications set forth in this Agreement and shall be manufactured, collected,
processed, tested, stored, handled and delivered to or placed with Buyer’s
designated agent/carrier in accordance with the Specifications and all
Applicable Laws, rules, regulations and current Good Manufacturing Practices
(cGMP) regulations as published and/or amended from time to time by the FDA.
Seller further warrants and represents that the Plasma delivered hereunder
shall
be free from defects in materials and workmanship and shall not, as of the
date
of delivery to or placement with Buyer’s agent/carrier, be adulterated or
misbranded with the meaning of the Federal Food, Drug and Cosmetic Act, shall
be
in full compliance with the Biological Products section of the Public Health
Service Act and applicable regulations, and shall be in full compliance with
any
applicable international, federal, state or local laws or
regulations.
(b) Seller
warrants and represents that clear and unrestricted title for all Plasma
purchased under this Agreement will pass to the Buyer upon acceptance by Buyer
as defined in Section 4.
(c) Seller
represents and warrants that Seller has all applicable Regulatory Approvals,
permits and licenses required in the performance of its obligations under this
Agreement, including without limitation the US FDA. Seller certifies it will
not
use in any capacity the services of any person, including any firm or individual
that has been debarred or is subject to debarment under the Generic Drug
Enforcement Act of 1992, amending the Food, Drug, and Cosmetic Act of 21 U.S.C.
335a (a) or (b). Seller agrees to notify Buyer promptly in the event any person
providing services to Seller under the scope of this Agreement is debarred
or
becomes subject to debarment.
(d) Seller
represents and warrants that the manufacture, processing, testing, distribution,
transport, storage, disposal and other handling of Plasma does not infringe
the
intellectual property rights of any third party and that Seller validly
possesses all licenses to third party intellectual property necessary or
appropriate for the manufacture, processing, testing, distribution, transport,
storage, disposal and other handling of Plasma.
8.3
General
Representations and Warranties
8.3.1 Seller’s
Representations and Warranties.
(a) The
Seller is a limited liability company duly organized, validly existing and
in
good standing under the laws of the State of Nevada. The Seller has all
requisite corporate power and authority to execute, deliver and perform this
Agreement and all other agreements entered into or delivered in connection
with
the transactions contemplated hereby. The Seller is qualified to do business
as
a foreign corporation in each jurisdiction in which the failure to so qualify
would have a Material Adverse Effect. The Seller has all authorizations,
approvals, orders, licenses, certificates and permits of and from all
governmental or regulatory bodies necessary to own and/or lease the properties
and assets employed by the Seller in the conduct of operating a plasma
collection center at the New Centers and to conduct its business and operations
as currently conducted.
(b) The
execution, delivery and performance of this Agreement and all other agreements
entered into in connection with the transactions contemplated hereby have been
duly and validly authorized by all necessary corporate action on the part of
the
Seller. This Agreement has been duly executed and delivered by the Seller,
constitutes the valid and binding obligation of the Seller, and is enforceable
in accordance with its terms. All other agreements to be entered into pursuant
to this Agreement by the Seller in connection with the transactions contemplated
hereby will be duly executed and delivered by the Seller, will constitute the
valid and binding obligations of the Seller, and will be enforceable in
accordance with their respective terms. The execution, delivery and performance
of this Agreement does not, and all other agreements entered into in connection
with the transactions contemplated hereby by the Seller will not, violate,
conflict with, result in a breach of or constitute a default under (or an event
which with due notice or lapse of time, or both, would constitute a breach
of or
default under) or result in the acceleration of, create in any party the right
to accelerate, terminate, modify or cancel, creation of any lien, security
interest or other encumbrance under (a) the Certificate of Incorporation or
By-laws of the Seller, as amended to date, (b) any note, agreement, contract,
license, instrument, lease or other obligation to which the Seller is a party
or
by which it is bound or to which any of its assets are subject, (c) any
judgment, order, decree, ruling or injunction or (d) any statute, law,
regulation or rule of any governmental agency or authority.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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(c) There
is
no action, lawsuit, proceeding, claim, controversy, arbitration or investigation
pending or, to the Seller’s knowledge, threatened against, or directly
involving, the Seller’s plasma collection business, inclusive of the New Center
Assets. There is no unsatisfied or outstanding order, writ, judgment, injunction
or decree affecting the Seller’s plasma collection business or the New Center
Assets. The Seller has complied and is complying with all laws, ordinances,
and
governmental rules and regulations applicable to it and its properties, assets
and business, the non-compliance with which would have a Material Adverse
Effect, and has obtained all Regulatory Approvals necessary for the ownership
of
its properties and the conduct of its business as currently
conducted.
(d) Except
for obtaining the Regulatory Approvals, no consent or approval of any third
party or governmental body is required for the consummation by the Seller of
the
transactions contemplated by this Agreement.
8.3.2 Buyer’s
Representations and Warranties.
(a) The
Buyer
is a corporation duly organized, validly existing and in good standing under
the
laws of the State of Delaware. The Buyer has all requisite power and authority
to execute, deliver and perform this Agreement and all other agreements entered
into or delivered in connection with the transactions contemplated
hereby.
(b) The
execution, delivery, and performance of this Agreement and all other agreements
entered into in connection with the transactions contemplated hereby have been
duly and validly authorized by all necessary corporate action on the party
of
the Buyer. This Agreement has been duly executed and delivered by the Buyer,
constitutes the valid and binding obligation of the Buyer and is enforceable
against it in accordance with its terms. All other agreements to be entered
into
pursuant to this Agreement by the Buyer in connection with the transactions
contemplated hereby will be duly executed and delivered by the Buyer, will
constitute the valid and binding obligations of the Buyer, and will be
enforceable in accordance with their respective terms. The execution, delivery
and performance of this Agreement does not, and all other agreements to be
entered into in connection with the transactions contemplated hereby by the
Buyer will not, violate, conflict with, result in a breach of or constitute
a
default under (or an event which with due notice or lapse of time or both,
would
constitute a breach of or default under) or result in the creation of any lien,
security interest or other encumbrance under (a) its charter or By-laws, (b)
any
note, agreement, contract, license, instrument, lease or other obligation to
which the Buyer is a party or by which it is bound, (c) any judgment, order,
decree, ruling or injunction or (d) any statute, law, regulation or rule of
any
governmental agency or authority.
Section
9. Term
and Termination
9.1 Term
of Agreement.
The term
of this Agreement shall commence on the Effective Date and shall continue in
full force and until the first to occur of (a) the failure of Seller to achieve
all Operating Benchmarks specified in this Agreement or (b) December 31, 2010
(the “Term”)
unless
terminated earlier in accordance with this Agreement.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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9.2 Termination
for Cause.
Either
Party shall have the right to immediately terminate this Agreement in the event
the other Party fails to perform any of its material obligations under this
Agreement and such failure to perform is not cured within 30 days of written
notice of such failure. The right of any Party to terminate this Agreement
pursuant to this Section shall not be affected in any way by its waiver or
failure to take action with respect to any prior default. The Party not in
default shall be entitled to terminate this Agreement without prejudice to
any
other rights conferred on it by this Agreement or under law or equity. A
termination shall not relieve a Party from any obligations that survive
termination or expiration of this Agreement.
9.3 Other
Termination Provisions.
Either
Party may immediately terminate this agreement if the other Party: (i) admits
in
writing that it is unable to pay its debts as they become due; (ii) starts
a
proceeding, or indicates its acquiescence to a proceeding started by another,
relating to it under any bankruptcy, reorganization, rearrangement, insolvency,
readjustment or debt, dissolution, liquidation or similar law; (iii) makes
an
assignment for the benefit of creditors; (iv) consents to the appointment of
a
receiver, trustee or liquidator for a substantial part of its property; (v)
files, or has filed against it, a petition in bankruptcy, reorganization,
rearrangement or insolvency which, if filed against it, is not dissolved or
dismissed within ninety (90) days after filing; or (vi) had entered against
it
an order by a court of competent jurisdiction appointing a receiver, trustee
or
liquidator for it or a substantial part of its property, or approving its
dissolution or termination, and if not consented to or acquiesced in by such
Party, such order in not vacated or set aside or stayed within ninety (90)
days.
9.4 Additional
Buyer Termination Rights. In
addition to the foregoing, Buyer shall have the right to immediately terminate
this Agreement at any time upon written notice and without further liability
or
obligation to Seller in the event that (a) Buyer is unable to obtain any
Regulatory Approvals necessary for it to take title to any of the New Centers;
(b) the FDA does not approve Buyer’s biologics license application for its lead
product candidate for the treatment of hereditary angioedema prior to
*
* *
; (c)
Seller is unable to obtain all Regulatory Approvals for the New Centers within
the timeframes contemplated for such event in this Agreement; (d) Seller is
unable to obtain the Minimum Commitments at the New Centers within the
timeframes contemplated for such event in this Agreement; (e) the Parties are
unable to consummate an acquisition of a New Center within the time period
specified in Section
5.3
or (f)
Seller is unable to comply with the construction timeframes agreed to by the
Parties in the Project Plan or is unable to commence operations of the New
Centers on or before the New Center Opening Dates established by the Management
Committee. In the event Buyer terminates this Agreement pursuant to Section
9.2
or subsections
(c) –
(f)
of this
Section
9.4,
Seller
shall reimburse Buyer for all amounts paid by Buyer pursuant to this Agreement
within fifteen days of Buyer’s request for such payment. In the event Buyer
terminates this Agreement pursuant to subsections
(a) and (b)
of this
Section
9.4,
Buyer
may exercise all rights and remedies available to it under this Agreement or
applicable law, except that Seller shall not be obligated to reimburse Buyer
for
any Performance Payments made by Buyer pursuant to Section
3.2
of this
Agreement prior to the date of such termination. Late payments of these amounts
shall accrue interest at the rate of 16% per annum until paid in full by Seller.
The rights and remedies of the Buyer set forth herein are in addition to all
other rights and remedies of the Buyer set forth elsewhere in this Agreement,
including without limitation Section
3.4,
and
under applicable law.
9.5 Effect
of Termination. In
the
event of any termination or expiration of this Agreement, all obligations by
the
Parties with respect to the construction, operation and sale of the New Centers
shall immediately expire, the Management Committee shall be dissolved and the
Parties shall have no further obligation to proceed with any transactions with
respect to such matters. The rights and remedies available to Buyer or the
Seller under this agreement or any other agreement among the parties are
cumulative and the exercise of any right or remedy shall not preclude or dismiss
Buyer’s or the Seller’s right to pursue any other or additional right or remedy,
including, without limitation, any claim for damages. The failure to exercise
any right or remedy in the event of any breach or default shall not constitute
a
waiver or adversely affect Buyer’s or the Seller’s right to exercise any right
or remedy in the future for the same or any other breach or default in the
future.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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9.6 Provisions
Surviving Termination.
The
provisions of this Agreement which by their nature would continue beyond any
termination or expiration of this Agreement, including without limitation
Sections
8, 9, 10, 11, 12, 13, 14 and 15
shall
survive any termination or expiration of this Agreement to the degree necessary
to permit their complete fulfillment or discharge.
9.7 Termination
of Prior Agreements. The
Parties hereby agree that upon the execution of this Agreement all prior
agreements for the purchase and sale of Plasma between Buyer and Seller or
any
affiliate of Seller are hereby terminated in all respects, other than any
provisions of any such agreement whose terms specifically survive termination.
Seller represents that it has all necessary right and authority to consent
to
the termination of such prior agreements on behalf of its affiliates, including
without limitation that certain agreement for the sale of Plasma entered into
by
Buyer and Biomedics, Inc. dated as of April 12, 2007, as modified to date.
Section
10. Indemnity
10.1.
Indemnification
by the Seller. The
Seller agrees to indemnify and hold harmless the Buyer, its Affiliates and
their
officers, agents and employees from and against any and all damages, losses,
obligations, liabilities, claims, actions or causes of actions (“Losses”)
incurred by the Buyer (or its Affiliates or their officers, agents and
employees) in connection with or arising from (i) any breach of any warranty
or
the inaccuracy of any representation of the Seller contained or referred to
in
this Agreement or any certificate delivered by or on behalf of the Seller
pursuant hereto, (ii) any breach by the Seller of, or failure by the Seller to
perform, any of its covenants or obligations contained in this Agreement, (iii)
the operations of the New Centers, or (iv) any negligent act or omission or
willful or unlawful misconduct of the Seller, its Affiliates or their officers,
or employees, agents or representatives, resulting in any loss of or damage
to
any property or injury or death of any person as a result of the Seller’s
provision of the Engineering Services or Construction Services or the operation
of the New Centers.
10.2 Indemnification
by the Buyer. The
Buyer
agrees to indemnify and hold harmless the Seller, its Affiliates and their
officers, agents and employees from and against any and all Losses incurred
by
the Seller (or its Affiliates or their officers, agents and employees) in
connection with or arising from (i) any breach of any warranty or the inaccuracy
of any representation of the Buyer contained or referred to in this Agreement
or
in any certificate delivered by or on behalf of the Buyer pursuant hereto,
(ii)
any breach by the Buyer of, or failure by the Buyer to perform, any of its
covenants and obligations contained in this Agreement.
10.3 Procedural
Matters.
Any
Party (the “Indemnified
Party”)
seeking indemnification hereunder shall give promptly to the party obligated
to
provide indemnification to such Indemnified Party (the “Indemnitor”)
a
written notice (a “Notice”)
describing in reasonable detail the facts giving rise to the claim for
indemnification hereunder. The failure of any Indemnified Party to give the
Notice promptly as required by this Section
10.3
shall
not affect such Indemnified Party’s rights hereunder this except to the extent
such failure is actually prejudicial to the rights and obligations of the
Indemnitor.
10.4 Defense
and Settlement.
In the
event of the initiation of any legal proceeding against the Indemnified Party
by
a third party, the Indemnitor shall have the sole and absolute right after
the
receipt of notice, at its option and at its own expense, to be represented
by
counsel of its choice and to control, defend against, negotiate, settle or
otherwise deal with any proceeding, claim, or demand which relates to any loss,
liability or damage indemnified against hereunder; provided, however, that
the
Indemnified Party may participate in any such proceeding with counsel of its
choice and at its expense. The parties hereto agree to cooperate fully with
each
other in connection with the defense, negotiation or settlement of any such
legal proceeding, claim or demand. To the extent the Indemnitor elects not
to
defend such proceeding, claim or demand, and the Indemnified Party defends
against or otherwise deals with any such proceeding, claim or demand, the
Indemnified Party may retain counsel, at the expense of the Indemnitor, and
control the defense of such proceeding. Without the consent of the other party,
such consent not to be unreasonably withheld if the settlement only requires
the
payment of money, neither the Party may settle any such proceeding which
settlement obligates the other party to pay money, to perform obligations or
to
admit liability, unless such settlement includes as an unconditional term
thereof, the giving by the claimant of an unconditional and complete release
of
claims in favor of the other Party.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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Section
11. Limitation
of Liability
11.1 EXCEPT
AS
PROVIDED IN THIS SECTION, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY
OR
ANY OTHER PERSON OR ENTITY FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, INDIRECT,
PUNITIVE OR EXEMPLARY DAMAGES HOWEVER CAUSED (INCLUDING ARISING OUT OF OR
RELATED TO THIS AGREEMENT, THE PERFORMANCE OF THE SERVICES), REGARDLESS
OF THE FORM OF ACTION, WHETHER FOR BREACH OF CONTRACT, BREACH OF WARRANTY,
TORT,
NEGLIGENCE, STRICT PRODUCT LIABILITY, OR OTHERWISE (INCLUDING, WITHOUT
LIMITATION, DAMAGES BASED ON WILLFULNESS, LOSS OF PROFITS, LOST REVENUES, OR
LOSS OF BUSINESS OPPORTUNITY), AND WHETHER
OR NOT SUCH PARTY HAS BEEN ADVISED OR KNEW OF THE POSSIBILITY OF SUCH DAMAGES.
11.2 The
foregoing limitation of liability shall not apply to (a) a material breach
by a
Party of its confidentiality obligations pursuant to this Agreement, or (b)
damages, losses and claims arising out of a Party’s gross negligence, willful
misconduct or fraud, or (c) a Party’s indemnification obligations under this
Agreement. The Parties acknowledge that this limitation of liability provision
has been separately negotiated, is a material inducement to the Parties entering
into this Agreement on the terms provided herein and shall be enforceable
regardless of whether any remedy provided for fails of its essential
purpose.
11.3 IN
NO
EVENT SHALL BUYER’S AGGREGATE LIABILITY ARISING OUT OF OR IN CONNECTION WITH
THIS AGREEMENT, FROM ANY AND ALL CAUSES, WHETHER BASED ON CONTRACT, TORT
(INCLUDING NEGLIGENCE), OR ANY OTHER CAUSE OF ACTION EXCEED *
* *
.
Section
12. Confidentiality
12.1 During
the Term and for a period of three (3) years thereafter, each Party shall (i)
hold the other Party’s Confidential Information in strict trust and confidence
and avoid the disclosure or release thereof to any other person or entity by
using at least the same degree of care as it uses to avoid unauthorized use,
disclosure, or dissemination of its own Confidential Information of a similar
nature, but not less than reasonable care, (ii) not use the other Party’s
Confidential Information for any purpose whatsoever except as expressly
contemplated under this Agreement, and (iii) not directly or indirectly, copy,
reproduce, use, publish, misappropriate, assign, or otherwise transfer or
disclose to any person the other Party’s Confidential Information, other than as
permitted pursuant to the terms of this Agreement, regardless of whether such
information was actually delivered to the receiving Party prior to the effective
date of this Agreement. “Confidential
Information,”
as
used herein, shall mean all information, trade secrets, inventions, data,
processes, or other records relating to a Party’s business, financial affairs or
operations, including but not limited to information related to business plans,
technology, source code, product or service requirements, customers, pricing,
techniques and methods, which is either marked or identified as confidential
or
which the receiving party knew or reasonably should have known, under the
circumstances, was confidential, whether disclosed in any tangible, electronic,
visual or other medium. Confidential Information shall also include all
information, know-how, trade secrets, data (technical or non-technical) or
other
confidential information concerning the operations, projects, organization,
business or finances of a Party or any third party to which a Party owes a
duty
of confidentiality, in whatever form, that a receiving Party learns, generates
or acquires in conjunction with the performance of the services pursuant to
this
Agreement. All files, records, documents, notes, or other items relating to
or
embodying Confidential Information that may be delivered to a receiving Party
or
to which a receiving Party may be granted access, shall remain the exclusive
property of the Party disclosing such Confidential Information. Neither Party
shall disclose to any third parties, including a customer of the other Party,
the existence or terms of this Agreement.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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12.2 A
receiving Party shall not disclose any Confidential Information except to its
officers, directors and employees (and those of its affiliates upon the prior
written approval by the disclosing Party) (collectively “Representatives”)
who
need to know such information for the purpose of performing the consulting
services contemplated by this Agreement and which persons shall be similarly
bound in writing (it being understood that each such Representatives shall
be
informed by the receiving Party of the confidential nature of such material
and
shall be directed to treat such material confidentially in accordance with
the
terms of this Agreement). A receiving Party agrees to be responsible for any
breach of this Agreement by any of its Representatives. Notwithstanding the
foregoing, a receiving Party shall not be required to maintain confidentiality
with respect to information (i) which is or becomes part of the public domain
not due to any act or omission by the receiving Party; (ii) of which it had
independent knowledge without confidentiality restriction prior to disclosure
by
the disclosing Party; (iii) which comes into the possession of the receiving
Party (without confidentiality restriction) in the normal and routine course
of
its own business from and through independent, non-confidential sources; or
(iv)
which is required to be disclosed by receiving Party governmental requirements.
If receiving Party is requested or required (by oral questions, interrogatories,
requests for information or document subpoenas, civil investigative demands,
or
similar process) to disclose any confidential information supplied to it by
the
disclosing Party, the receiving Party shall promptly notify the disclosing
Party
of such request(s) prior to any disclosure so that the disclosing Party may
seek
an appropriate protective order. Seller acknowledges that Buyer may be required
to disclose the terms of this Agreement pursuant to its reporting obligations
under the Securities Exchange Act of 1934, as amended, and to file a copy of
this Agreement as an exhibit to a periodic report required to be filed by Buyer
thereunder.
12.3 Failure
on the part of the receiving Party to abide by this Section
12
may
cause the disclosing Party irreparable harm for which damages will not be an
adequate remedy at law. Accordingly, the non-breaching Party has the right
to
seek injunctive to prevent any threatened or actual violations of this section
in addition to whatever remedies it may have at law. In such a proceeding,
the
Party allegedly breaching this Agreement expressly
waives the defense that a remedy in damages will be adequate and any requirement
in an action for specific performance or injunction for the posting of a bond
by
the non-breaching Party.
Section
13. Force
Majeure.
A
Party’s failure to perform its obligations under this Agreement due to “acts of
God,” acts of governments (other than the specific requirements expressed
elsewhere in this Agreement), riots, wars, accidents, deficiencies in supplies,
materials or transportation or other causes of any nature beyond such Party’s
control, including with limitation acts of terrorism, civil commotion, national
emergency, epidemics, hurricane, embargo, flood, fire or any law, proclamation,
regulation, or ordinance or other act to order of any court, government or
governmental agency (other than the specific requirements expressed elsewhere
in
this Agreement), shall not be deemed to be a breach of this Agreement, provided
that the non-conforming Party (i) provides the other Party timely written notice
of the existence and nature of any reason for nonperformance, and (ii) resumes
performance immediately upon the elimination of the impeding force majeure.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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Section
14. Additional
Agreements between the Parties
14.1 Recordkeeping
and Audits.
In
addition to its obligation to maintain certain records pursuant to Section
4.5,
Seller
shall, in accordance with standard accounting practices maintain complete and
accurate accounting records with respect to all of its activities under this
Agreement and shall retain such records for a period not less than three (3)
years the date of termination or the closing of the acquisition by Buyer of
the
New Centers. The Seller shall afford to the officers, employees and authorized
representatives of the Buyer (including, without limitation, independent public
accountants, financial advisors and attorneys) reasonable access during normal
business hours, upon reasonable advance notice, to the offices, properties,
employees and business and financial records (including computer files,
retrieval programs and similar documentation) of the New Centers and Seller’s
books and records pertaining to the New Centers regardless of where such
documents may be located, to the extent the Buyer shall reasonably deem
necessary or desirable and shall furnish to the Buyer or its authorized
representatives such additional information concerning the New Centers as shall
be reasonably requested. The Buyer agrees that such investigation shall be
conducted in such a manner as not to interfere unreasonably with the operations
of the New Centers. If in the course of any investigation pursuant to this
Section, the Buyer's officers, employees or authorized representatives discover
any breach of any representation or warranty contained in this Agreement, or
any
circumstance or condition that upon the lapse of time would constitute such
a
breach, the Buyer covenants that it will promptly so inform the Seller. The
investigation will be conducted at Buyer’s expense, unless it reveals material
instances on non-compliance by Seller, in which case Seller will reimburse
Seller for all reasonable costs and expenses incurred in connection with such
audit. Any confidential or proprietary information disclosed in the course
of
the audit will be subject to the confidentiality provisions under this
Agreement.
14.2 Non-Competition.
During
the term of this Agreement and for a period of five years after any termination
or expiration of this Agreement, except for a termination based on the breach
of
this Agreement by Buyer, Seller agrees that it will not, directly or indirectly
enter into or become associated with or otherwise operate any plasma collection
centers within a radius of *
* * from
the
location of any New Center.
14.3 Non-Solicitation.
Neither
party shall, during the Term, and for two years thereafter, directly or
indirectly hire or attempt to hire any employee of the other party who performed
substantial work on any project covered by this Agreement without such other
party’s prior written consent; provided that the foregoing shall not prohibit
either party from issuing advertisements of a general nature not specifically
directed at any such employee and hiring any such employee so long as such
party
is in compliance with this Section
14.3.
For
purposes of clarity, this restriction shall not be applicable to the employment
by Buyer of any employees of Seller who worked at a New Center in connection
with the Buyer’s acquisition of a New Center.
14.4 Acknowledgement.
The
Parties acknowledge and agree that the covenants contained in this Section
14
are fair
and reasonable and of a special unique character which gives them peculiar
value
and exist in order to protect the Parties and that the Parties would not have
entered into this Agreement without such covenants being made to it. If any
court shall hold that the duration or geographic scope of the non-competition
clause, or any other restriction contained in this Section
14
is
unenforceable, it is our intention that same shall not thereby be terminated
but
shall be deemed amended to delete therefrom such provision or portion
adjudicated to be invalid or unenforceable or in the alternative such judicially
substituted term may be substituted therefor. The Parties further acknowledge
that damages alone will not be an adequate remedy for any breach by any Party
of
the covenants contained in this Section
14,
and
accordingly, each expressly agrees that, in addition to any other remedies
which
each may have, each shall be entitled to injunctive relief in a court of
competent jurisdiction. The Parties acknowledge that the covenants contained
in
this Section
14
are
separate and distinct from, and shall not be merged with, any similar covenants
made by a Party in any other agreement, document or understanding. The
provisions of this Section
14
shall
survive the termination of this Agreement.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
Page
22
14.5 Notifications.
The
Buyer, on the one hand, and the Seller, on the other hand, shall promptly notify
the other of any action, suit or proceeding that shall be instituted or
threatened against such party to restrain, prohibit or otherwise challenge
the
legality of any transaction contemplated by this Agreement. Each Party will
give
prompt written notice to the other Party of any material adverse development
causing a breach of any of its own representations and warranties in this
Agreement. No disclosure by any Party pursuant to this Section, however, shall
be deemed to prevent or cure any misrepresentation, breach of warranty, or
breach of covenant.
14.6
Obtaining
Permits and Licenses.
The
Seller shall be responsible for obtaining all Regulatory Approvals required
by
any governmental agency with respect to the construction and operation of the
New Centers and the New Center Assets. The Buyer will cooperate reasonably
with
the Buyer in obtaining such permits and licenses. The Seller will use its best
efforts and act diligently to secure, any consents and approvals, including
the
Regulatory Approvals, required to effect the transactions contemplated by this
Agreement.
14.7 Insurance.
Seller
shall provide and maintain in full force and effect, at no cost to the other
Party, usual and customary insurance coverage for all obligations relating
to or
arising under this Agreement, including, without limitations, errors and
omissions, products liability, general liability and related insurance coverage
with policy limits in the following minimums:
(a)
|
Commercial
General Liability coverage of $1,000,000.00 per incident and $2,000,000.00
in aggregate.
|
(b)
|
Products
and Completed Operations Liability coverage of $5,000,000.00 per
incident
and $5,000,000.00 in the aggregate.
|
(c)
|
Workers
compensation as required by federal, state and local
law.
|
(d)
|
Employers
Liability limits of $1,000,000.00 per
incidents.
|
Section
15. General
(a)
Press
Releases and Public Announcements.
Neither
the Buyer, on the one hand, nor the Seller, on the other hand, shall, without
the approval of the other, make any press release or other public announcement
concerning the transactions contemplated by this Agreement, except as and to
the
extent that any such party shall be so obligated by law, in which case the
other
party shall be advised and the parties shall use their best efforts to cause
a
mutually agreeable release or announcement to be issued; provided, however,
that
the foregoing shall not preclude communications or disclosures necessary to
implement the provisions of this Agreement or to comply with the accounting
and
disclosure obligations of the Securities and Exchange Commission or the rules
of
any stock exchange or Nasdaq or to enable the Buyer to obtain debt or equity
financing.
(b) No
Third-Party Beneficiaries.
This
Agreement shall not confer any rights or remedies upon any Person other than
the
Parties and their respective successors and permitted assigns.
(c)
Entire
Agreement.
This
Agreement (including the Exhibits and Schedules hereto and the documents
referred to herein) constitutes the entire agreement between the Parties and
supersedes any prior understandings, agreements, or representations by or
between the Parties, written or oral, to the extent they relate in any way
to
the subject matter hereof, including any prior agreements between the
Parties.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
Page
23
(d)
Succession
and Assignment.
This
Agreement shall be binding upon and inure to the benefit of the Parties named
herein and their respective successors and permitted assigns. No Party may
assign either this Agreement or any of its rights, interests, or obligations
hereunder without the prior written approval of the other Party, not to be
unreasonably withheld; provided,
however,
that
Buyer may, without the consent of Seller, but upon written notice (i) assign
any
or all of its rights and interests hereunder to one or more of its Affiliates;
(ii) designate one or more of its Affiliates to perform its obligations
hereunder (in any or all of which cases Buyer nonetheless shall remain
responsible for the performance of all of its obligations hereunder); or (iii)
assign this Agreement as part of the sale or transfer of those of its assets
to
which this Agreement pertains or in connection with a merger, consolidation
or
acquisition.
(e)
Counterparts.
This
Agreement may be executed in one or more counterparts (including by means of
facsimile), each of which shall be deemed an original but all of which together
will constitute one and the same instrument.
(f)
Notices.
All
notices, requests, demands, claims, and other communications hereunder shall
be
in writing. Any notice, request, demand, claim, or other communication hereunder
shall be deemed duly given (i) when delivered personally to the recipient,
(ii)
1 business day after being sent to the recipient by reputable overnight courier
service (charges prepaid), (iii) 1 business day after being sent to the
recipient by facsimile transmission or electronic mail, or (iv) 4 business
days
after being mailed to the recipient by certified or registered mail, return
receipt requested and postage prepaid, and addressed to the intended recipient
as set forth below:
If
to Buyer:
Xxxxxx
Xxxxxx Ph. D.,
Chief
Executive Officer
Lev
Pharmaceuticals, Inc.
000
Xxxxx Xxxxxx, Xxxxx 0000
Xxx
Xxxx, Xxx Xxxx 00000
Fax:
|
If
to Seller:
Plasma
Centers of America, LLC
0000
Xxxxxx Xxxxxx
Xxxxxx,
Xxxxxxxxxx 00000
Attention:
Fax:
|
Any
Party
may change the address to which notices, requests, demands, claims, and other
communications hereunder are to be delivered by giving the other Party notice
in
the manner herein set forth.
(g) Governing
Law. This
Agreement shall be governed by and construed in accordance with the domestic
laws of the State of New
York without
giving effect to any choice or conflict of law provision or rule (whether of
the
State of New
York or
any
other jurisdiction) that would cause the application of the laws of any
jurisdiction other than the State of New
York.
(h)
Amendments
and Waivers.
No
amendment of any provision of this Agreement (inclusive of any Exhibits or
Schedules) shall be valid unless the same shall be in writing and signed by
Buyer and Seller. Seller may consent to any such amendment at any time prior
to
the Closing with the prior authorization of its board of directors. No waiver
by
any Party of any provision of the Agreement or any default, misrepresentation,
or breach of warranty or covenant hereunder, whether intentional or not, shall
be valid unless the same shall be in writing and signed by the Party making
such
waiver nor shall such waiver be deemed to extend to any prior or subsequent
default, misrepresentation, or breach of warranty or covenant hereunder or
affect in any way any rights arising by virtue of any prior or subsequent such
occurrence. The failure of any party hereto to enforce at any time any provision
of this Agreement shall not be construed to be a waiver of such provision,
nor
in any way to affect the validity of this Agreement or any part hereto or the
right of any party thereafter to enforce each and every such provision.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
Page
24
(i)
Severability.
Wherever
possible, each provision hereof shall interpreted in such manner as to be
effective and valid under applicable law, but in case any one or more of the
provisions contained herein shall, for any reason, be held to be invalid,
illegal or unenforceable in any respect, such provision shall be ineffective
to
the extent, but only to the extent, of such invalidity, illegality or
unenforceability without invalidating the remainder of such invalid, illegal
or
unenforceable provision or provisions or any other provision hereof, unless
such
a construction would be unreasonable.
(j)
Expenses.
Each of
Buyer and Seller, will bear its own costs and expenses (including legal fees
and
expenses) incurred in connection with this Agreement and the transactions
contemplated hereby, except as otherwise specified in this
Agreement.
(k)
Interpretation.
(a) Any
reference to any federal, state, local, or foreign statute or law shall be
deemed also to refer to all rules and regulations promulgated thereunder, unless
the context requires otherwise. The word including
shall
mean including without limitation. The Exhibits and Schedules identified in
this
Agreement are incorporated herein by reference and made a part hereof. Articles,
title and headings to sections herein are inserted for convenience of reference
only and are not intended to be a part of or to affect the meaning or
interpretation of this Agreement. Disclosure of any fact or item in any Schedule
hereto referenced by a particular section in this Agreement shall be deemed
to
have been disclosed with respect to every other section in this Agreement.
Neither the specification of any dollar amount in any representation or warranty
contained in this Agreement nor the inclusion of any specific item in any
Schedule hereto is intended to imply that such amount, or higher or lower
amounts, or the item so included or other items, are or are not material, and
no
party shall use the fact of the setting forth of any such amount or the
inclusion of any such item in any dispute or controversy between the parties
as
to whether any obligation, item or matter not described herein or included
in
any Schedule is or is not material for purposes of this Agreement. Unless this
Agreement specifically provides otherwise, neither the specification of any
item
or matter in any representation or warranty contained in this Agreement nor
the
inclusion of any specific item in any Schedule hereto is intended to imply
that
such item or matter, or other items or matters, are or are not in the ordinary
course of business, and no party shall use the fact of the setting forth or
the
inclusion of any such item or matter in any dispute or controversy between
the
parties as to whether any obligation, item or matter not described herein or
included in any Schedule is or is not in the ordinary course of business for
purposes of this Agreement.
(b)
The
parties acknowledge and agree that: (i) each party and its counsel reviewed
and
negotiated the terms and provisions of this Agreement and has contributed to
its
revision; (ii) the rule of construction to the effect that any ambiguities
are
resolved against the drafting party shall not be employed in the interpretation
of this Agreement; and (iii) the terms and provisions of this Agreement shall
be
construed fairly as to all parties hereto and not in favor of or against any
party, regardless of which party was generally responsible for the preparation
of this Agreement.
Remainder
of page intentionally left blank. Signature page follows.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
Page
25
IN
WITNESS WHEREOF, the duly authorized representatives of the Parties have
executed this Agreement as of the date first above written.
BUYER:
LEV
PHARMACEUTICALS, INC.
|
SELLER:
PLASMA
CENTERS OF AMERICA, LLC
|
|
/s/
Xxxxxx X. Xxxxxx
|
/s/
Xxxx Xxxxxxxx
|
|
By:
Xxxxxx X. Xxxxxx
|
By:
Xxxx Xxxxxxxx
|
|
Title:
Chairman and Executive Vice President
|
Title:
President
|
|
Dated:
04/09/08
|
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
Page
26
Schedule
1
PLASMA
SPECIFICATIONS
LEV
PHARMACEUTICALS, INC.
SOURCE
PLASMA SPECIFICATIONS:
a)
Origin of Plasma:
Human
Source Plasma collected from donors at USA-FDA licensed donor center(s). Each
donor center must adhere to PPTA (iQPP) voluntary standards. Plasma must be
collected as Source Plasma as defined by the FDA in 21 CFR Part 640 Subpart
G,
Source Plasma 640.60.
b)
Selection/Exclusion
Criteria for Donors (Donations): The
selection/exclusion criteria used for determining donor eligibility was
performed in accordance to the current SOP’s of the collecting facility at the
time of donation from donors meeting all donor screening and donor selection
criteria. Plasma must be collected from donors who fulfill all requirements
as
Qualified Donors as defined by iQPP standards and in accordance with 21 CFR
Part
640 Subpart G, Source Plasma Suitable Donors 640.63.
c)
Examination
and Interview of Donors: The
donor
examination and/or interview was performed in accordance to the current SOP’s of
the collecting facility and performed in accordance with all US requirements
at
the time of donation.
d)
Screening
Tests on Individual Donations:
Testing
requirements as described in 21 CFR 640.67 and 640.71 must be met and shall
meet
the following criteria:
TEST
|
TEST
RESULT
|
Anti
HIV ½
|
Non-reactive
|
HBsAg
|
Non-reactive
|
Anti-HCV
|
Non-reactive
|
HIV
NAT
|
Negative
|
HCV
NAT
|
Negative
|
Syphilis
|
Negative
or Non-reactive donor
|
Atypical
Antibody
|
Negative
donor
|
A
list of
all current test kits or methods shall be submitted to Lev Pharmaceuticals,
and
updated in the event a test or method is changed.
For
Lookbacks and notification for destruction of plasma, notification must be
made
to Lev Pharmaceuticals:
§
|
Within
three working days upon receipt of reactive or positive test results
from
a donor from whom prior or subsequent units have been shipped to
Lev
Pharmaceuticals
|
§
|
Within
one working day of notification of Post Donation Information resulting
in
product recalls or seizure concerning units shipped to Lev
Pharmaceuticals
|
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
Page
27
§
|
Within
three working days of receipt of Post Donation Information not resulting
in a seizure or recall (e.g. tattoo, body piercing, high risk
behavior)
|
e)
Density: The
density of plasma must be 1.026.
f)
Shelf
life:
Each
bottle must have at least a remaining shelf life of 5 years as of
delivery.
g)
System
to Trace Donations:
Supplier
shall maintain systems that all donations are traceable to the individual
donors.
h)
Plasma
Collection System:
Source
Plasma collection in bottles in accordance to current SOP’s of the collecting
facility at the time of donation. Plasma must be collected in bottles that
fulfill all requirements sited by the FDA in 21 CFR Part 640 Subpart G, Source
Plasma 640.64(b). Plasma collection must fulfill all additional requirements
as
defined by the FDA in 21 CFR Part 640 Subpart G, Source Plasma
640.64.
Plasma
units that fall into one of the following categories is unacceptable for
shipment to Lev Pharmaceuticals:
§
|
Units
with reactive or positive viral marker test results; Prior or subsequent
units from donors that have been found to be reactive/positive for
required testing
|
§
|
Hemolyzed
or lipemic units
|
§
|
Units
with frozen plasma on the outside of the
container
|
§
|
Broken
or contaminated units
|
§
|
Untested
or units with incomplete testing (except for units shipped to RxCrossroads
under “holding” )
|
§
|
Orphan
units
|
§
|
Units
having errors that breech traceability such as units that cannot
be traced
back to an individual donor
|
i)
Plasma
Storage and Transport: Source
Plasma must be frozen by cooling rapidly at -20ºC or colder, as soon as possible
and at the latest within 24h of collection. Plasma storage and transportation
has been maintained at -20ºC or colder. The Seller will provide one additional
sample for each unit shipped to Purchaser with the Shipment packaged in separate
boxes as per shipment id.
j)
Quality
Specifications – Documentation:
Each
shipment of Plasma must have the following shipment documentation and electronic
information associated with it.
·
|
Xxxx
of Lading (copy)
|
·
|
Certificate
of Quality (see Exhibit B below)
(original)
|
·
|
Shipping
Report Summary
|
·
|
Shipment
Report Detail
|
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
Page
28
·
|
Plasma Packing and Test Report Forms |
·
|
E-File
(see requirements below)
|
The
Xxxx
of Lading shall include the following information:
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
The
Shipping Report Summary shall include the following information:
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
The
Shipping Report Detail shall include the following information:
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
Page
29
The
Plasma Packing and Test Report shall include the following
information:
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
·
|
***
|
The
originals of this documentation are to be mailed to the following
address:
Lev
Pharmaceuticals
k)
Electronic
data of shipment: Every
shipment will include an electronic file that contains information about the
shipment. Included in these files is the following information:
·
|
***
|
·
|
***
|
-
|
***
|
***
-
|
***
|
***
-
|
***
|
***
|
-
|
***
|
·
|
Header-record
containing
the following information:
|
o
|
***
|
|
o
|
***
|
|
o
|
***
|
|
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
Page
30
o
|
***
|
|
o
|
***
|
|
o
|
***
|
|
-
|
A
number of detail-records
containing the following information for each plasma
unit:
|
o
|
***
|
|
o
|
***
|
|
o
|
***
|
|
o
|
***
|
|
o
|
***
|
|
o
|
***
|
|
o
|
***
|
|
o
|
***
|
|
1.
|
***
|
2.
|
***
|
3.
|
***
|
4.
|
***
|
5.
|
***
|
6.
|
***
|
7.
|
***
|
8.
|
***
|
- |
Trailer-line
containing
the following information:
|
Each
bottle will be labeled with at least the following information:
•
Supplier
name and license number
•
Plasma
Type
•
Unit Identification
will be by means of barcode unit number type CODE128
•
Volume
•
Anticoagulant
composition
•
Storage
temperature
•
Expiration
date
•
Plasma
bottle lot number (on bottle)
Each
case
will be labeled with at least the following information:
·
|
Supplier
name and license number
|
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.
EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK
[***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
Page
31
·
|
Plasma
Type
|
·
|
Shipment
Id
|
·
|
Case
number
|
Exhibit
A
Center
A
|
Center
B
|
Center
C
|
||||
Selection
of New Center Locations
|
*
* *
|
*
* *
|
*
* *
|
|||
Lease
Negotiation
|
*
* *
|
*
* *
|
*
* *
|
|||
Construction
Permitting
|
*
* *
|
*
* *
|
*
* *
|
|||
Commencement
of Construction
|
*
* *
|
*
* *
|
*
* *
|
|||
Opening
Preparation
|
*
* *
|
*
* *
|
*
* *
|
|||
New
Center Opening Dates
|
*
* *
|
*
* *
|
*
* *
|
|||
Note:
Dates
indicated above specify the date by which each specific event is to be completed
or occur.
[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
Page
32