First Addendum to Product Supply Agreement
Exhibit
10.22
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CONFIDENTIAL MATERIALS OMITTED
AND FILED SEPERATLY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISK DENOTE
OMISSIONS.
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Talecris
BIOTHERAPEUTICS
First
Addendum to
This
First Addendum (this "Addendum") to that certain
Product Supply Agreement dated June 12, 2006, as previously amended on December
19, 2006, June 25, 2007, and August 29, 2007, and as hereinafter amended from
time to time (the "Agreement"), is entered into
as of August 15, 2009, and effective as of September
1,
2009
(the "Addendum Effective
Date"), by and between Talecris Biotherapeutics, Inc., ("Talecris") headquartered at 79
X.X. Xxxxxxxxx Drive, 4101 Research Commons, P.O. Box 110526, Research Xxxxxxxx
Xxxx, Xxxxx Xxxxxxxx 00000 and Emergent Product Development Gaithersburg Inc.
("Emergent"), a Delaware
corporation having offices at 000 Xxxxxxxxxxxx Xxxxx, Xxxxxxxxxxxx, XX 00000.
For the purposes of this Addendum, Emergent and Talecris shall each be deemed a
"Party" and together the
"Parties." All terms not
defined herein shall have the meaning set forth in the Agreement.
WHEREAS,
the Parties entered into the Agreement in order to, among other things, allow
for Talecris to receive, process, and manufacture human plasma, plasma
intermediates, final container products (such as Finished Product) and other
materials (collectively, the "Materials") on behalf of
Emergent or its agents; and
WHEREAS,
the Parties have determined that, in addition to the rights and obligations set
forth in the Agreement, Talecris has in the past and will continue to store,
warehouse, and hold Materials on behalf of Emergent or its agents as more fully
described herein.
NOW,
THEREFORE, in consideration of the foregoing and the mutual covenants herein
contained, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties agree as
follows:
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1)
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Business
Terms.
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a.
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Services. Upon
the terms and conditions set forth below or as otherwise required by the
Agreement or the applicable Material Storage Schedule, Emergent hereby
engages Talecris to store Materials as specified in a Material Storage
Schedule executed hereunder (the "Services"). Talecris
reserves the right, upon reasonable advance notice to Emergent, to refuse
to accept or accumulate Materials on behalf of Emergent that are in
addition to those Materials specified in any executed Material Storage
Schedule; provided, however, that the foregoing right of refusal shall not
apply to any Materials set forth in any mutually-agreed rolling forecast
of Materials to be manufactured by
Talecris.
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b.
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Standards and
Conditions.
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i.
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General. Unless
otherwise specified in the applicable Material Storage Schedule or
required by applicable law, cGMP (if applicable) or good practices for the
industry, Talecris shall use Commercially Reasonable Efforts in the
performance of Services.
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ii.
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Storage
Conditions. Unless otherwise agreed in writing, Talecris will
store, otherwise handle and maintain the Materials using the same degree
of care, under the same conditions, and in the same facilities as Talecris
does for its own products and materials of a similar nature. Talecris
shall perform the Services in accordance with its then-current standard
operating procedures, plans, protocols, and business judgment. Talecris
reserves the right to transfer Materials to other Talecris-owned or
controlled locations or facilities as reasonably necessary to ensure the
continued proper storage and handling of such Materials; provided,
however, that Talecris shall not make any transfer to any location or
facility not owned or controlled by Talecris without providing Emergent
with at least thirty (30) days' written notice and allowing Emergent a
reasonable opportunity to inspect or otherwise obtain relevant information
regarding the suitability of such alternate facility. Talecris shall be
solely responsible for any breaches of this Addendum or the Agreement by a
third party storage agent or transporter, except in the event that such
third party is engaged under emergency circumstances in an attempt to
prevent or limit loss of, or damage to, the Materials pursuant to section
1(b)(iv) below.
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iii.
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Location.
Talecris will store Materials at any of its facilities in Clayton, NC
and/or Benson, NC (the "Facilities"), unless
otherwise agreed between the Parties. Regardless of location, Talecris
shall monitor and record temperature as required by applicable laws and
regulations, and in any event, shall do so in the same manner it addresses
such data concerning its own products and materials in the same
Facilities.
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iv.
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Emergency
Situations. In the event of an emergency or other urgent situation
that Talecris, in its best judgment, believes may lead to damage or risk
to the Materials, Talecris reserves the right to transfer some or all
Materials to an alternative location or storage facility. To the extent
reasonably possible and prudent, Talecris will transfer the Materials in
the same manner and with the same frequency that Talecris transfers its
own products and materials of a similar nature that are being stored at
the same Facility and in proximity to the Materials. In the event that
Talecris utilizes the facilities of any third party in connection with
such transfer or eventual storage, Talecris shall use commercially
reasonable efforts to require such third party to be bound to Talecris by
obligations with respect to the storage and handling of Materials that are
substantially similar to those contained in this Addendum. Talecris shall
notify Emergent promptly of any transfer made pursuant to this subsection,
and use its best commercial efforts to notify Emergent in advance. In the
event that Emergent requires or prohibits moving, modifying or storing the
Materials in a manner against the recommendations or instructions of
Talecris, Emergent shall, except for the gross negligence or intentional
misconduct of Talecris or its agents, be solely responsible for any harm
or damage to the Materials incurred thereafter with respect to the
Materials stored or moved against the recommendations or instructions or
Talecris. In the event that Emergent determines, in its sole discretion,
to re-transfer or otherwise assume control of or responsibility for such
transferred Materials, Talecris shall reasonably cooperate with and assist
Emergent in completing such
activities.
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v.
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Performance.
With respect to certain Materials which may be specified above, the
Parties agree as follows:
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1.
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Final
Product: Storage of Final Product by Talecris will not be deemed
"Services" under this Addendum until such Final Product is released by
Talecris to Emergent pursuant to the terms of the Agreement and Talecris
issues the corresponding invoice to Emergent for the product Processing
Fee.
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2.
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Plasma
and Paste: Storage of plasma and paste by Talecris will not be deemed
"Services" until after Talecris has held such Materials for three (3)
months.
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vi.
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Removal of
Materials. Talecris may, upon six (6) months' prior written notice
to Emergent, require removal of Materials from the Facility; provided,
however, that Talecris shall not require such removal as a result of any
agreement to store a third party's products or materials of a similar
nature at the Facility. Notwithstanding the foregoing, in the event that
Emergent reasonably determines that it cannot locate a suitable storage
facility for the Materials or otherwise arrange for alternate storage
within such six-month period, Talecris shall use commercially reasonable
efforts to cooperate with Emergent and will extend the storage period at
the Facility until such time as Emergent secures alternate storage for the
Materials. In no event shall the foregoing storage period extend beyond
twelve (12) months from the original removal notice date. Emergent may,
upon ten (10) business days' prior written notice, require delivery (in
accordance with the terms of the Agreement) of all or any part of the
Materials from the Facility; provided, however, that the Parties
acknowledge and agree that Talecris shall be allowed additional time to
prepare Materials for delivery if reasonably necessary and upon notice to
Emergent of the reasons for any such delay. Upon request by either Party
to deliver Materials to Emergent, Talecris shall cooperate with Emergent
with respect to removal of Materials and, at Emergent's expense, follow
Emergent's reasonable written instructions for such removal. Talecris
reserves the right to withhold such cooperation until all amounts due and
payable by Emergent to Talecris (except to the extent disputed in good
faith) in connection with this Addendum are paid to
Talecris.
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c.
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Delivery
Conditions. Delivery of Materials will be made to Emergent or such
other Persons approved by Emergent in writing at such time(s) as
reasonably determined by Emergent.
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d.
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Compensation / Payment
Terms
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i.
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Subject
to the terms of any Material Storage Schedule, Emergent agrees to pay, and
Talecris agrees to accept payment, for all Services properly rendered
during the term of this Addendum. Payment and prices shall be as set forth
on the applicable Material Storage Schedule. Talecris shall be solely
responsible for its expenses related to this Addendum unless otherwise
expressly agreed by Emergent in writing. Such expenses are not to exceed
$175 per pallet per month without the express written preapproval of
Emergent, which will not be unreasonably withheld. Notwithstanding the
foregoing, Emergent shall be responsible for any reasonable expenses
necessarily incurred by Talecris in connection with preservation,
relocation or transfer of Materials as described in Paragraph 1) b) iv)
above.
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ii.
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Emergent
shall pay all undisputed amounts to Talecris net-thirty (30) days from the
date of an invoice showing in reasonable detail the basis for such
invoice, and the amount currently due, as set forth herein. All invoices
shall be submitted in writing to Emergent as
follows:
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Manner and Location for
Payments: U.S. first-class mail to primary business address
Accounting
Codes (Must be noted on all invoices
for. payment to be
processed):
G/L
No.: Cost
Center:
Project Code (if
applicable):
Address for Invoices to
Emergent: Emergent
BioSolutions Inc.
0000
Xxxxxxxx Xxxx., Xxxxx 000
Xxxxxxxxx,
XX 00000
Attn:
Accounts Payable
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e.
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Risk of Loss /
Insurance.
Risk of loss for Materials stored by Talecris pursuant to this
Addendum shall be governed by the terms of the Agreement. Notwithstanding
the foregoing, the parties acknowledge and agree that except to the extent
caused by Talecris' gross negligence, intentional misconduct or material
breach of this Addendum, upon the release of Finished Product to Emergent,
all risk of loss for such Finished Product shall be borne by Emergent,
even if such Finished Product is stored by Talecris pursuant to this
Addendum.
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f.
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Warranty &
Disclaimer. TALECRIS IS NOT A COMMERCIAL STORAGE FACILITY OR
STORAGE SERVICES PROVIDER. ACCORDINGLY, WITH RESPECT TO THE SERVICES
COVERED BY THIS ADDENDUM, TALECRIS MAKES NO WARRANTY OF MERCHANTABILITY,
SATISFACTORY QUALITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR
OTHERWISE.
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g.
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Limitation of
Liability; Damages. Talecris shall have no liability hereunder to
the extent arising from negligent acts or omissions. Except to the extent
caused by Talecris' gross negligence,
intentional misconduct or material breach of this Addendum, Talecris'
aggregate liability for any losses, injury or damages to persons,
Materials, or properties arising out of or in connection with this
Addendum or for any other claims, losses, costs or damages whatsoever
arising out of or resulting from or in any way related to the Services or
this Addendum from any causes or causes, arising under any theory of law,
shall be limited to the total amount of compensation actually received by
Talecris from Emergent under this Addendum during the preceding eighteen
(18) months. NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY IN CONTRACT
OR IN TORT FOR INCIDENTAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES OR FOR LOST
PROFITS ARISING HEREUNDER, EXCEPT TO THE EXTENT OF GROSS NEGLIGENCE OR
WILLFUL MISCONDUCT ON THE PART OF SUCH PARTY, ITS EMPLOYEES, AGENTS,
REPRESENTATIVES, OR SUBCONTRACTORS. The liability of each of Talecris and
Purchaser to the other for any damages arising under this Agreement shall
not exceed five million U.S. Dollars
($5,000,000).
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h.
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Insurance.
Emergent, at its own expense, shall submit to Talecris prior to
commencement of the Services under this Addendum, certificates of
insurance evidencing that such insurance was obtained. Deductible amounts
under the foregoing policies shall be paid by Emergent. Without limiting
the insurance requirements under the Agreement, Emergent shall maintain at
least $2,000,000 in transit insurance and $15,000,000 in property
insurance, covering Materials (including finished products) stored at
Talecris' facility, pursuant to this Addendum. For the duration of this
contract and for three years thereafter, Emergent and Talecris shall
maintain General Liability and Products Liability insurance or
self-insurance with minimum limits of $5,000,000 per occurrence.
Certificates of insurance providing evidence of such coverage shall be
provided to each respective Party when the contract is signed. Talecris
shall reasonably cooperate with Emergent for the scheduling and completion
of any reasonable or necessary insurance-related loss-control inspections
of the Facility, which inspections shall not occur more frequently than
once per year during the Term of this Addendum. The findings of any such
inspections shall be used solely to establish Emergent's insurance rates
and terms, and shall not be understood or used to obligate Talecris to
modify its conduct or policies, or otherwise to take or refrain from
taking any specific action.
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i.
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Nonexclusive.
Notwithstanding the terms of the Agreement (including Section 2.04
(Exclusivity)), and notwithstanding the terms of the Exclusivity Agreement
referenced in such Section, the parties agree that except with respect to
removal of Materials as specified in Paragraph 1) b) vi) above and storage
commitments described in Paragraph 1) a), the Services governed by this
Addendum shall be nonexclusive with respect to each Party. Nothing shall
prohibit Talecris from providing similar or identical services to other
entities, and nothing shall prohibit Emergent from obtaining similar or
identical services from other
entities.
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2)
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Confidentiality.
This Addendum, and the rights and obligations arising hereunder, shall be
deemed confidential information subject to Article 13 (Confidentiality) of
the Agreement.
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3)
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Applicable Law.
This Addendum and any matters arising directly or indirectly herefrom
shall be governed by and construed and enforced in accordance with the
laws of the United States and the internal laws of the State of New York,
without regard to conflicts of law
principles.
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4)
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Effect. Except
as expressly set forth herein, this Addendum shall not limit or otherwise
affect any term or provision of the Agreement, and all other terms and
conditions of the Agreement shall survive and shall remain in full force
and effect. This Addendum is hereby incorporated into and made a part of
the Agreement. Specifically, but without limitation, the following
sections of the Agreement shall, except as modified herein, apply to this
Addendum: 15.11 (Force Majeure), 15.13 (Limitation of
Damages).
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5)
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Term and
Termination.
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a.
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Term. Unless
earlier terminated as set forth below, this Addendum shall be in effect
from the Addendum Effective Date until the termination or expiration of
the Agreement, or until terminated in accordance with the terms of this
Section.
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b.
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Termination.
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i.
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This
Addendum may be terminated by mutual written agreement by the
Parties.
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ii.
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Either
Party may terminate this Addendum for a material breach hereof by the
other Party by providing thirty (30) days written notice to the other
Party, unless such breach is cured within such thirty (30) day
period.
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iii.
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Except
for removal of Materials as provided in Paragraph 1) b) vi), either Party
may terminate this Addendum without cause by providing ninety (90) days
written notice to the other Party.
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iv.
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Termination
of this Addendum shall not affect the binding nature or effectiveness of
the Agreement. Breach of this Addendum by either Party shall not be deemed
a breach of the Agreement.
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6)
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Counterparts.
This Addendum may be executed via facsimile signature and in any number of
counterparts with the same effect as if all of the Parties had signed the
same document. All fully executed counterparts shall be construed together
and shall constitute one and the same
Agreement.
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IN
WITNESS WHEREOF, the Parties have executed this Addendum as of the Addendum
Effective Date,
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TALECRIS
BIOTHERAPEUTICS, INC.
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EMERGENT
PRODUCT DEVELOPMENT
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GAITHERSBURG
INC.
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By: /s/
Xxxxx Xxxxxxxxxxx
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By: /s/
Xxxx Xxxxx
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Name: Xxxxx
Xxxxxxxxxxx
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Name: Xxxx
Xxxxx
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Title: Senior
Director Global Supply Chain
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Title:
SVP Manufacturing OPS
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SCHEDULE
A-1
MATERIAL
STORAGE SCHEDULE #1
This
Schedule 1-A is made as part of the "FIRST ADDENDUM TO PRODUCT SUPPLY AGREEMENT"
(the "Addendum"), by and
between Talecris Biotherapeutics, Inc., ("Talecris") and Emergent
Product Development Gaithersburg Inc. ("Emergent"), and made subject
to the terms and conditions of the Product Supply Agreement referenced therein
(the "Agreement").
Pricing:
Talecris shall perform the Services at the prices set forth herein, with respect
to the Materials specified in this Material Storage Schedule. Talecris reserves
the right to increase such prices after the first anniversary of this Material
Storage Schedule by a percent not to exceed the greater of (a) five percent (5%)
or (b) CP-M. "CPI-M" shall mean a percentage equal to the unadjusted percentage
change for the previous twelve-month period (ending four months prior to the
date of Talecris' price increase) published in the Consumer Price Index for
Medical Care, by the U.S. Department of Labor, Bureau of Labor
Statistics.
Terms
for Material Storage Services Already Provided through August 2009:
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Material
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AIG
Lot #
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Cost
per Pallet
per
Month
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Number
of
Pallets
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Storage
Start-Date
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Total
Charges
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Final
Container
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[**] | $ | [**] | 2 |
March
2007
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$ | [**] | ||||||||||
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Final
Container
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[**]
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$ | [**] | 2 |
June
2008
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$ | [**] | ||||||||||
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Final
Container
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[**]
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$ | [**] | 2 |
June
2009
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$ | [**] | ||||||||||
IN
WITNESS WHEREOF, the Parties have executed this Schedule as of the date of the
last signature below:
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TALECRIS
BIOTHERAPEUTICS, INC.
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EMERGENT
PRODUCT DEVELOPMENT
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GAITHERSBURG
INC.
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By:
/s/ Xxxxx Xxxxxxxxxxx
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By: /s/
Xxxx Xxxxx
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Name: Xxxxx
Xxxxxxxxxxx
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Name: Xxxx
Xxxxx
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Title: Senior
Director Global Supply Chain
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Title: SVP
Manufacturing OPS
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Date: August
27, 2009
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Date: 1
Sep 09
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