Document:

exv10w25

 

Exhibit 10.25

AMENDED AND RESTATED

LOAN AGREEMENT

     THIS AMENDED AND RESTATED LOAN AGREEMENT is made as of July 29th, 2005, by
and between BIOPORT CORPORATION, a Michigan corporation, of Lansing, Michigan (“Borrower”), and
FIFTH THIRD BANK, a Michigan banking corporation, of East Lansing, Michigan (“Lender”).

     Borrower and Lender are parties to Loan Agreements dated as of July 30, 2004 and October 8,
2004, under which Bank agreed to extend to Borrower revolving credit loans of up to $10 million in
the aggregate at any time outstanding. This Amended and Restated Loan Agreement amends and
restates the Loan Agreements of June 25, 2003, July 30, 2004 and October 8, 2004, in their
entirety, to read as follows:

     Lender and Borrower agree as follows:

SECTION 1. DEFINITIONS.

     In this Agreement:

     “Affiliate” of a Person means a Person that now or in the future controls, is controlled by,
or is under common control with, the Person.

     “Agreement” means this Amended and Restated Loan Agreement as amended, including the schedules
attached to this Loan Agreement.

     “Capitalized Lease Obligation” means any obligation of Borrower to pay future rentals under a
lease that, in accordance with GAAP, is required to be shown as a liability on Borrower’s balance
sheet.

     “Collateral” means the proceeds of the Government Contracts.

     “Collateral Document” means each security agreement, mortgage, pledge agreement, assignment,
guaranty and every other agreement and document that has been or in the future is, or is required
to be, given by Borrower or any third party to secure any Lender Indebtedness.

     “Contamination” or “Contaminated” means, when used with reference to any real or personal
property, that a Hazardous Substance is present on or in the property in any amount or level that
exceeds any legal limit set forth under Environmental Law. “Contamination or “Contaminated” shall
not include latent, unexposed asbestos in any building located on any of the real property unless
and until exposure that exceeds the foregoing legal limit occurs due to renovation or otherwise.

     A Person “controls” another Person if the Person has, directly or indirectly, the power to
direct or cause the direction of the management or policies of the other Person.

 

 

     “Default” means an event, condition or circumstance that, with the lapse of time or giving of
notice (absent any permitted cure), would be an Event of Default.

     “DOD Contract” means Contract No. W9113M-04-D-0002, dated January 3, 2004, between U.S. Army
Space and Missile Defense Command and Borrower, as it has been and in the future is amended.

     “Eligible Account” means, as of the relevant date of determination, an account receivable of
Borrower arising in the ordinary course of business:

     (a) that is not more than 90 days old from the earlier of the original invoice date or
the date of shipment of the goods or performance of the services that gave rise to the
account receivable;

     (b) that arises from Borrower’s sale and shipment of goods or Borrower’s performance of
services, in the ordinary course of Borrower’s business;

     (c) that is the valid, binding and enforceable obligation of the account debtor and is
not subject to any offset, counterclaim or defense;

     (d) that is evidenced by an invoice that is dated not later than the 15th
day post the date of shipment of the goods or performance of the services and payable in
full no more than 90 days after the invoice date and that is not evidenced by an instrument
or chattel paper;

     (e) that is owned by Borrower and is not subject to any security interest, lien,
encumbrance, assignment or trust, except in favor of Lender;

     (f) in which Lender holds a valid and perfected security interest;

     (g) that is owing by the federal government under a Government Contract;

     (h) that does not arise from a sale of goods on consignment or on a sale-or-return
basis;

     (i) that is owing by an account debtor to whom Borrower does not have any maintenance
obligation with respect to the goods or services the sale of which gave rise to the account
receivable;

     (j) that is not subject to retainage; and

     (k) as to which Lender has not notified Borrower is, in Lender’s good faith judgment,
uncollectible, in whole or in part, within 60 days.

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     “Environmental Law” means at any time any applicable federal, state, local or foreign law
(including common law), ordinance, rule, regulation, permit, order or other requirement that then
(1) regulates the quality of air, water, soil or other environmental media, (2) regulates the
generation, management, transportation, treatment, storage, recycling or disposal of any waste, (3)
protects public health, occupational safety and health, natural resources or the environment or (4)
establishes liability for the investigation, removal or remediation of, or harm caused by,
Contamination.

     “ERISA” means the Employee Retirement Income Security Act of 1974, as now and in the future
amended, together with all regulations issued under it.

     “Event of Default” has the meaning specified in Section 9 of this Agreement.

     “FDA” means the U.S. Food and Drug Administration.

     “GAAP” means generally accepted accounting principles as consistently applied by Borrower.

     “Government Contracts” means the HHS Contract and the DOD Contract.

     “Guarantor” means each Person who has guaranteed or in the future guarantees payment of all or
part of the Lender Indebtedness.

     “Hazardous Substance” means at any time any substance or waste that is then regulated by or
subject to any Environmental Law.

     “HHS Contract” means Contract No, 200-2005-11811, dated May 5, 2005, between Department of
Health and Human Services (‘HHS’) and Borrower, which provides for Borrower to sell to HHS, and for
HHS to purchase from Borrower, anthrax vaccine, as that Contract is amended in the future.

     “Indebtedness” means indebtedness for borrowed money, indebtedness representing the deferred
purchase price of property (excluding indebtedness under normal trade credit for property or
services purchased in the normal course of operations), any obligation under a note payable or
draft accepted representing an extension of credit, indebtedness (whether or not assumed) secured
by a mortgage, security interest or other lien on property, and any Capitalized Lease Obligation.
By way of clarification, for the avoidance of doubt, and without limiting the foregoing,
“Indebtedness” shall not include deferred revenue, deferred tax liabilities or any indebtedness for
borrowed money or representing the deferred purchase price of property, whether or not secured,
that is Subordinated Indebtedness.

     “Intangible Collateral” means the Collateral described in Sections 5.1 and 5.2 of this
Agreement.

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     “Intellectual Property” means all patents, trademarks, service marks, trade names, copyrights,
licenses and similar rights.

     “Leader Indebtedness” means any indebtedness, obligation or liability, of whatever type or
nature, that Borrower now or in the future owes to Lender under this Agreement.

     “Loan” means any loan that Lender makes to Borrower under this Agreement.

     “Loan Document” means this Agreement, the Revolving Credit Note and every other promissory
note that Borrower has given or in the future gives to Lender under this Agreement, each renewal,
extension and replacement of the Revolving Credit Note, each Collateral Document and every other
agreement, instrument and document that has been or in the future is signed or delivered in
connection with this Agreement or in connection with any Lender indebtedness.

     “Material Adverse Effect” means any material adverse effect upon (1) the validity, performance
or enforceability of any Loan Document, (2) the Borrower’s properties taken as a whole, (3) a
Government Contract or any other material contract, (4) business operations, profits or financial
condition of Borrower, (5) the ability of Borrower or any Guarantor to fulfill any material
obligation under any Loan Document or (6) the ability of Lender to take possession of, collect or
otherwise realize upon any Collateral or other security for the Lender Indebtedness.

     “Maturity” of an indebtedness or obligation means the time when that indebtedness or
obligation has become due and payable, for whatever reason.

     “Non Disclosure Agreement” means that Nondisclosure Agreement, dated November 18, 2002,
between Borrower and Lender.

     “Note” means the Revolving Credit Note and any other promissory note that Borrower has signed
or in the future signs and that now or in the future evidences any Lender Indebtedness, including
any renewals, extensions or modifications.

     “Permitted Lien” means (1) a security interest, mortgage or other lien in favor of Lender, (2)
a lien for taxes that are not delinquent or, in a jurisdiction where payment of taxes is abated
during the period of any contest, being contested in good faith by appropriate proceedings, if
adequate reserves for it have been set aside on Borrower’s books, in accordance with GAAP, (3) a
lien or encumbrance that is described on Borrower’s balance sheet dated December 31, 2004, that
Borrower has delivered to Lender and (4) an inchoate materialmen’s, mechanics’, workmen’s,
repairmen’s or other like lien arising in the ordinary course of business, if the obligation
secured is not delinquent or is being contested in good faith by appropriate proceedings, if
adequate reserves for it have been set aside upon Borrower books in accordance with GAAP and if the
lien does not jeopardize any Collateral and does not have a Material Adverse Effect.

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     “Person” means an individual and a corporation, partnership, limited liability company, trust,
association and any other entity.

     “Plan” means an “employee pension benefit plan” with respect to which Borrower or any
Affiliate is an “employer” or “party in interest,” as ERISA defines those terms.

     “Revolving Credit Commitment” means the lesser of 75% of Borrower’s Eligible Accounts or
$10,000,000.

     “Revolving Credit Loans” has the meaning specified in Section 3.1 of this Agreement.

     “Revolving Credit Note” has the meaning specified in Section 3.3 of this Agreement.

     “Schedule” means a schedule attached to this Agreement.

     “Subordinated Indebtedness” means, at any time, all Indebtedness that Borrower owes to any
Person or Persons to the extent that its repayment is subordinated to payment of the Lender
Indebtedness in form and manner satisfactory to Lender.

     “Subsidiary” means a corporation or a limited liability company all of the capital stock,
membership interests and other equity interests of and in which are owned by Borrower.

     “Term Loan” has the meaning specified in Section 4 of this Agreement.

     “Term Loan Note” has the meaning specified in Section 4 of this Agreement.

SECTION 2. WARRANTIES AND REPRESENTATIONS.

     Borrower represents and warrants to Lender, and agrees, as follows:

     2.1 Borrower is a corporation that is duly organized, validly existing and in good standing
under the laws of the state of Michigan. Borrower is duly qualified and authorized to do business,
and is in good standing as a foreign corporation, in each jurisdiction in which the failure to be
so qualified or authorized to do business would have a Material Adverse Effect.

     2.2 Borrower has all requisite corporate power and authority and all necessary licenses and
permits to own and operate its properties and to carry on its business as it now conducts it and as
it contemplates that it will conduct it in the future. Borrower is in compliance with all laws,
rules and regulations that apply to Borrower, its operations or its properties, except where any
noncompliance could not have a Material Adverse Effect.

     2.3 The audited balance sheets of Borrower as of December 31, 2001 and December 31, 2002, and
December 31, 2003, and the unaudited balance sheets of Borrower as of December 31, 2004 and March
31, 2005, and the related statements, if applicable, of income, of retained earnings and of changes
in financial position for the periods then ended, copies of all of which

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have been delivered to Lender, have been prepared in accordance with GAAP and present fairly the
financial position of Borrower as of those dates and the results of its operations for those
periods. Since the date of the most recent of those financial statements, there has not been any
change in Borrower’s financial condition or operations that has not been disclosed to Lender in
writing and could have a Material Adverse Effect.

     2.4 Neither this Agreement nor any financial statement that Section 2.3 above refers to nor
any other written statement that Borrower has furnished to Lender in connection with the
negotiation of any Loan, contains any untrue statement of a material fact or omits a material fact
necessary to make the statements contained in this Agreement, the financial statement or other
written statement not misleading.

     2.5 Except as previously disclosed to Lender in writing, there is not any proceeding pending
or, to the knowledge of the officers and directors of Borrower, threatened, before any court,
governmental authority or arbitration board or tribunal, against Borrower, that, if determined
adversely to Borrower, could reasonably be expected to have a Material Adverse Effect. Borrower is
not in default with respect to any order, judgment or decree of any court, governmental authority
or arbitration board or tribunal.

     2.6 All of the issued and outstanding shares of capital stock of Borrower are owned by
Emergent BioSolutions Inc., a Delaware corporation. There are not any outstanding options,
warrants or rights to purchase, and there is not any agreement for the subscription, purchase or
acquisition of, any such shares of Borrower’s capital stock.

     2.7 Borrower has good and marketable title to all of the intangible assets that it purports
to own, including the intangible assets reflected in the financial statements referred to in
Section 2.3 of this Agreement, free and clear of all liens, encumbrances, security interests,
claims, charges and restrictions, except Permitted Liens.

     2.8   (a) Borrower owns, jointly owns, or has been licensed the right to use pursuant to
licenses that remain in full force and effect, Intellectual Property sufficient to operate its
business as it is presently being conducted.

          (b) Except as previously disclosed to Lender in writing, there is no action, suit or
proceeding pending against or, to the knowledge of Borrower, threatened against Borrower (1)
challenging the rights of Borrower in any Intellectual Property owned or used by Borrower or (2)
alleging that products manufactured, used, imported or sold by Borrower conflict with,
misappropriate, infringe or violate the Intellectual Property rights of any third party, except in
each case for actions, suits or proceedings the outcome of which individually or in the aggregate
would not have a Material Adverse Effect.

     2.9 Borrower has full power and authority to sign, deliver and perform the Loan Documents. The
signing, delivery and performance of the Loan Documents: (1) have been duly authorized by
appropriate corporate action of Borrower, (2) will not violate the provisions of Borrower’s
articles of incorporation or bylaws or of any law, rule, judgment, order, agreement or

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instrument to which Borrower is a party or by which it is bound and (3) do not require any approval
or consent of any public authority or other third party, except for (a) consents and approvals that
have been obtained prior to the date of this Agreement; or (b) approvals or consents the failure of
which to obtain, individually or in the aggregate, do not have a Material Adverse Effect and do not
materially impair the ability of Borrower to perform its obligations under the Loan Documents.
Borrower has properly signed and delivered the Loan Documents, and the Loan Documents are the valid
and binding obligations of Borrower and are enforceable against Borrower in accordance with their
terms, subject to laws of general application relating to bankruptcy, insolvency and the relief of
debtors and the rules of law governing specific performance, injunctive relief and other equitable
remedies.

     2.10 Borrower has filed each tax return that it is required (after taking account of any
properly-filed and valid and effective extensions) to file in any jurisdiction, and Borrower has
paid each tax, assessment, fee and other governmental charge upon it or upon its assets, income or
franchises before the time when its nonpayment could give rise to a lien that could have a Material
Adverse Effect. Borrower does not know of any proposed additional tax assessment against it.

     2.11 Borrower does not have any investments in the securities of any Person. Borrower does
not intend to carry or purchase any “margin security” within the meaning of Regulation U of the
Board of Governors of the Federal Reserve System, 12 C.F.R. Chapter II.

     2.12 Attached to this Agreement as Schedule 2.12 is a list of all Plans. No Plan has been
terminated since the effective date of ERISA. No Plan is a “multi-employer plan” within the meaning
of Section 3(37)(A) of ERISA. An “accumulated deficiency” (within the meaning of Section 412 of the
Internal Revenue Code, as amended) or a “reportable event” (as defined in Title IV of ERISA) has
not occurred with respect to any Plan. Neither Borrower nor any Affiliate has incurred any material
liability to the Pension Benefit Guaranty Corporation (“PBGC”) or otherwise under ERISA. The PBGC
has not started or, to the knowledge of Borrower, threatened to start a proceeding against Borrower
or any Affiliate under ERISA.

     2.13 Borrower is not, and no person, firm or corporation that has “control” of Borrower is, an
“executive officer,” “director” or “person who directly or indirectly, or in concert with one or
more persons owns, controls or has the power to vote more than 10 percent of any class of voting
securities” (within the meaning of 12 U.S.C. Section 375(b) and regulations issued under that
section), of Lender, Fifth Third Bancorp or any subsidiary of Fifth Third Bancorp.

     2.14 With such exceptions as do not have, individually or in the aggregate, a Material Adverse
Effect:

          (a) No written notice, demand, citation, or order has been received, no penalty has been
assessed, and no action, suit or proceeding is pending or, to the knowledge of the Borrower, is
threatened by any governmental agency pursuant to or arising out of any Environmental Laws; and

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          (b) There are no liabilities of the Borrower not recorded on the Borrower’s financial
statements in accordance with GAAP arising as a result of Borrower’s real or personal property (a)
being Contaminated; (b) being the source of any Contamination of any adjacent property or any
groundwater or surface water; or (c) being the source of any air emissions in excess of any legal
limit or standard under Environmental Laws.

     2.15 Borrower has furnished to Lender a complete and correct copy of each Government Contract,
including all amendments.

     2.16 Schedule 2.16 lists each Affiliate and describes Borrower’s relationship to it, including
ownership of capital stock.

SECTION 3. REVOLVING LINE OF CREDIT.

     3.1 Subject to satisfaction of the conditions precedent set forth in Section 10 of this
Agreement and as long as there shall not have occurred any Default or Event of Default, that in
each case has not been cured or waived, Lender shall extend to Borrower from time to time loans in
amounts (“Revolving Credit Loans”) that shall not at any time in the aggregate exceed the Revolving
Credit Commitment.

     3.2 If the aggregate principal amount of the Revolving Credit Loans outstanding at any time
exceeds the Revolving Credit Commitment, then Borrower shall immediately repay the amount of the
Revolving Credit Loans that is required to eliminate the excess.

     3.3 All Revolving Credit Loans shall be evidenced by and payable with interest in accordance
with the terms of a promissory note in the form attached to this Agreement as Schedule 3.3
(“Revolving Credit Loan Note”), which Borrower shall sign and deliver to Lender.

     3.4 Each Revolving Credit Loan shall be in the amount $1,000 or a whole multiple of that
amount and shall be made upon Borrower’s request.

     3.5 Borrower shall have the right to prepay all Revolving Credit Loans, in whole or in part,
at any time without penalty or any other premium or charge. Borrower may reborrow amounts that it
prepays, subject to the other provisions of this Agreement.

     3.6 Unless it is sooner terminated or Lender extends it in writing, Lender’s obligation to
make or to renew Revolving Credit Loans shall expire on May 1, 2006. If Lender extends it, then
Lender’s obligation to make or renew Revolving Credit Loans shall expire on the date stated in the
extension. If Lender’s obligation to make or renew Revolving Credit Loans expires, then the
aggregate unpaid principal balance of all outstanding Revolving Credit Loans, together with all
accrued interest on them, shall be due and payable in full on the expiration date.

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SECTION 4. TERM LOAN

     4.1 On August 10, 2004, Lender made a term loan to Borrower in the principal amount of
$2,400,000 (“Term Loan”).

     4.2 The Term Loan is evidenced by and payable in accordance with a Term Note dated August 10,
2004, payable to Lender, that Borrower executed and delivered to Lender (“Term Loan Note”).

     4.3 Nothing in this Agreement amends or modifies the Term Loan or the Term Loan Note.

SECTION 5. SECURITY.

     5.1 Simultaneously with the signing and delivery of this Agreement, Borrower is signing and
delivering to Lender an Amended and Restated Security Agreement granting to Lender a valid first
security interest in the Collateral, and in all proceeds to secure payment and performance of all
Lender Indebtedness.

     5.2 Simultaneously with the signing and delivery of this Agreement, Borrower is assigning to
Lender, as security, all payments that are now or in the future owing to Borrower under each
Government Contract, to secure payment and performance of all Lender Indebtedness.

     5.3 Borrower has signed and delivered to Lender two mortgages, dated July 30, 2004, that grant
to Lender valid first liens on the real property located in Ingham County, Michigan and Clinton
County, Michigan, described in them, to secure the Lender Indebtedness described in them. If at any
time after July 31, 2005, Borrower gives to Lender a written request that Lender discharge either
or both of the mortgages and if at that time (a) neither a Default nor an Event of Default shall
have occurred and be continuing, (b) Borrower is not indebted to Lender, other than in respect of
the Term Loan or one or more Revolving Credit Loans and (c) Lender is not obligated to extend any
loan or other credit facility to Borrower, then Lender shall, within 30 days after it receives the
request, comply with the request.

     5.4 Borrower shall sign and deliver to Lender all financing statements, assignments, documents
of title and other documents, agreements and instruments in connection with the perfection or
priority of the security provided for above, and shall take all further actions that Lender
reasonably requests in connection with the perfection or priority of the security provided for
above.

SECTION 6. AFFIRMATIVE COVENANTS.

     From the date of this Agreement and until all Lender Indebtedness is fully paid and Lender
does not have any obligation to extend loans or other credit facilities to Borrower hereunder,
Borrower shall:

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     6.1 Furnish to Lender, within 120 days after the end of each of Borrower’s fiscal years,
beginning with its fiscal year ending December 31, 2005, an audited financial report prepared in
accordance with GAAP by independent certified public accountants that are satisfactory to Lender
(it being understood that Borrower’s current auditors are satisfactory to Lender), containing (1)
Borrower’s balance sheet as of the end of that year, its related statements of operations for that
year and its statement of cash flows for that year, (2) any management letters that those certified
public accountants prepare in conjunction with such audits, (3) all notes and other financial
schedules that are customarily included in the audited financial statements and (4) the unqualified
opinion of the certified public accountants stating that the financial statements for the fiscal
year present fairly the financial position, results of operations and cash flows in conformity with
GAAP.

     6.2 Furnish to Lender within 20 days after the end of each month, beginning with the month of
May, 2005, an unaudited financial report, the accuracy of which is certified to by the President or
chief financial officer of Borrower, prepared in accordance with GAAP, containing Borrower’s
balance sheet as of the end of the period and its income statement showing the results of its
operations for the portion of its fiscal year then elapsed.

     6.3 Furnish to Lender within 20 days after the end of each month, beginning with the month of
May, 2005, a detailed aging of all of Borrower’s accounts receivable that are in excess of
$100,000, in form reasonably satisfactory to Lender.

     6.4 (1) Promptly inform Lender of any occurrence that is a Default or an Event of Default and
of any other occurrence that has had, could reasonably be expected to have, a Material Adverse
Effect; (2) grant to Lender or its representatives the right to examine its books and records
during normal business hours no more frequently than once per calendar quarter; (3) maintain
complete and accurate books and records of its transactions in accordance with Borrower’s current
accounting practices; and (4) furnish to Lender any information that it reasonably requests
concerning Borrower’s financial condition and results of operations within 45 days after Lender
makes the request.

     6.5 (1) Maintain insurance, including, but not limited to, fire and extended coverage
insurance, workers’ compensation insurance and commercial and general liability insurance with
responsible insurance companies on its properties and against the risks and in the amounts and in a
manner consistent with Borrower’s current practice; (2) furnish to Lender upon its request the
details with respect to that insurance and satisfactory evidence of that insurance coverage. Each
insurance policy that this Section requires shall be written or endorsed in a manner that makes
losses, if any, payable to Borrower and Lender as their respective interests appear and shall
include, where appropriate, a mortgage clause or lender’s loss payable endorsement in favor of
Lender in form and substance reasonably satisfactory to Lender.

     6.6 Pay and discharge, as often as they are due and payable, all taxes and assessments of
whatever nature that are levied or assessed against it or any of its properties, unless and to the
extent only that (1) in a jurisdiction where payment of taxes and assessments is abated during the

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period of any contest, those taxes or assessments are being contested in good faith by appropriate
proceedings and (2) Borrower shall have set aside on its books adequate reserves with respect to
those taxes and assessments.

     6.7 Maintain its existence as a corporation in good standing in the State of Michigan and its
qualification in good standing in every other jurisdiction in which the failure to be qualified or
authorized to do business could have a Material Adverse Effect; continue to conduct and operate its
business substantially as it presently conducts and operates it subject to Borrower’s right,
subject to Section 7.5, upon prior written notice to Lender, to expand its business, make
acquisitions, enter joint ventures and similar arrangements and enter into new, but related,
business lines; and comply with all governmental laws, rules, regulations and orders that apply to
it, the failure to comply with which could have a Material Adverse Effect.

     6.8 Keep in good working order and condition, ordinary wear and tear excepted, all of its
material assets and properties that are necessary to the conduct of its business, in a manner
consistent with industry practice, other than machinery and equipment that Borrower disposes of as
permitted by Section 7.2.

     6.9 Maintain its principal commercial deposit accounts with Lender.

     6.10 (1) Comply in all material respects with the applicable requirements of ERISA and the
Internal Revenue Code with respect to each Plan, including, without limitation, all provisions
regarding minimum funding requirements and requirements as to plan termination insurance; (2)
within 30 days after it is filed, furnish to Lender a copy of each annual report and annual return,
with all schedules and attachments, that ERISA requires Borrower to file with the Department of
Labor or the Internal Revenue Service pursuant to ERISA in connection with each Plan for each Plan
year; (3) notify Lender immediately of any fact or circumstance, including, but not limited to, any
“reportable event” (as defined in Title IV of ERISA), that might be grounds for termination of a
Plan by the Pension Benefit Guaranty Corporation or for the appointment by the appropriate United
States District Court of a trustee to administer the Plan, together with a statement, if Lender
requests it, as to the reason the fact or circumstance has occurred and the action, if any, that
Borrower proposes to take to avoid termination of the Plan; and furnish to Lender, upon its
request, any additional information concerning any Plan that Lender reasonably requests.

     6.11 Notify Lender in writing within 10 days after Borrower receives any notice of the
beginning of (1) any proceeding or investigation by a federal or state environmental agency against
Borrower regarding Borrower’s compliance with Environmental Laws or (2) any other judicial or
administrative proceeding or litigation by or against Borrower in each case that would result in a
Material Adverse Effect.

SECTION 7. NEGATIVE COVENANTS.

     From the date of this Agreement and until all Lender Indebtedness is fully paid and Lender
does not have any obligation to extend loans or other credit facilities to Borrower, Borrower shall
not, without the prior written consent of Lender:

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     7.1 Create or permit to exist any lien, security interest, mortgage, pledge, attachment,
garnishment, execution or other legal process or encumbrance on any Collateral, other than liens
created under the Loan Documents and Permitted Liens.

     7.2 Sell, lease or otherwise dispose of any of its assets with a value in excess of $250,000,
except for (1) the sale of inventory in the ordinary course of business (as Borrower conducts its
business on the date of this Agreement) and (2) the disposition, in the ordinary course of
business, of machinery and equipment that has become obsolete, damaged, unsuitable or unnecessary
for its business.

     7.3 Make loans or advances to any Person, except for (1) loans and advances to Affiliates or
Subsidiaries and (2) loans and advances to Persons that are not Affiliates or Subsidiaries as long
as the aggregate loans and advances outstanding to all Persons that are not Affiliates or
Subsidiaries does not at any time exceed $250,000.

     7.4 Guarantee, endorse, assume or otherwise incur or suffer to exist any contingent liability
in respect of any obligation of any other Person, other than an Affiliate or Subsidiary, except by
the endorsement of negotiable instruments for deposit or collection in the ordinary course of
business and except for guarantees under which the maximum possible liability of Borrower does not
at any time exceed $500,000 in the aggregate.

     7.5 Enter into any merger, consolidation, reorganization or recapitalization, or purchase or
otherwise acquire all, or substantially all, of the assets, obligations or capital stock of or any
other interest in any Person if either (1) a Default or an Event of Default shall have occurred and
is then continuing or (2) the merger, consolidation, reorganization, recapitalization, purchase or
acquisition would result in or cause a Default or an Event of Default.

     7.6 Subordinate any indebtedness that any Person other than an Affiliate or Subsidiary owes to
Borrower to Indebtedness that that Person owes to any other Person.

     7.7 Engage in any transaction with any Affiliate on terms that are less favorable to Borrower
than Borrower could obtain at the time in a comparable transaction in an arm’s-length dealing with
a Person other than an Affiliate; except that this Section 7.7 shall not prevent Borrower from
continuing any transaction with an Affiliate in existence on October 8, 2004.

     7.8 Issue, incur, assume or permit to remain outstanding any Indebtedness that is not
Subordinated Indebtedness, other than (1) Lender Indebtedness, (2) Indebtedness the proceeds of
which are used to pay the purchase price of real property acquired by Borrower, and (3) other
Indebtedness that does not exceed $500,000 in the aggregate at any time outstanding.

     7.9 Become a contributing employer with respect to a multi-employer employee benefit plan
within the meaning of Section 3(37)(A) of ERISA (29 U.S.C. 1002), as amended by Section 302 of the
Multi-Employer Pension Plan Amendments Act of 1980 (other than any Plans described on Schedule 2.12
as being multi-employer plans); or establish for any of its employees

- 12 -

 

any employee benefit plan that has, or may in the future incur, any unfunded past service
liability.

     7.10 Change its name, fiscal year or method of accounting, except as GAAP requires, and except
that Borrower may change its name if Borrower gives Lender 60 days’ prior written notice of the
name change and takes any action that Lender reasonably considers necessary to continue the
perfection of the security interests and liens that the Collateral Documents grant to Lender.

     7.11 Enter into any amendment to or modification of, or terminate all or any part of, any
Government Contract that in any way materially adversely affects the payments due to the Borrower
under such Government Contracts without Lender’s prior written consent, which consent shall not be
unreasonably withheld, conditioned or delayed.

SECTION 8. APPLICATION OF PROCEEDS.

     Borrower shall apply the proceeds of the Revolving Credit Loans for any proper business
purpose, including without limitation for working capital.

SECTION 9. EVENTS OF DEFAULT AND REMEDIES.

     9.1 Each of the following is an “Event of Default” under this Agreement not cured within 30
days (unless some other cure period is provided below) from written notice of default:

          A. If Borrower defaults in the payment of the principal or interest of any Lender
Indebtedness, when and as it is due and payable, whether by acceleration or otherwise and
does not cure the default within ten (10) business days after Lender gives Borrower notice
of the default.

          B. If Borrower fails to perform any of its other obligations under, or to comply with
any of the terms, conditions and covenants that are contained in, this Agreement or any
other Loan Document or other agreement, document or instrument that Borrower or any third
party has given or in the future gives to Lender to secure any Lender Indebtedness, if, in
the case of a failure that can be cured, Borrower does not cure the failure within thirty
(30) days after Lender gives Borrower notice of it.

          C. If Borrower defaults in the payment of any other Indebtedness and does not cure the
default within thirty (30) days after Lender gives Borrower notice of the default, if the
default results in a right of the holder of the Indebtedness to accelerate the maturity of
such Indebtedness in an amount in excess of $500,000.

          D. If any warranty or representation that Borrower makes in this Agreement or any
statement, warranty or representation that Borrower or any third party has made or in the
future makes in any other Loan Document, certificate, report or other document, instrument
or agreement that is delivered under this Agreement or in

- 13 -

 

connection with any Lender Indebtedness is false or inaccurate in any material respect when
made.

          E. If any guaranty that now or in the future secures payment of all or any part of the
Lender Indebtedness is, other than by its terms, terminated or limited for any reason
without the written consent of Lender.

          F. If Borrower fails to perform any of its obligations under any Government Contract
within any cure period so provided or if a Government Contract is terminated for any reason
other than by expiration in accordance with its terms.

          G. If, as a result of any order, judgment or other action of the FDA, a court or any
other governmental agency or entity, Borrower is required to stop selling all or any of the
anthrax vaccine that it has agreed to sell under a Government Contract.

          H. If Borrower (1) applies for or consents to the appointment of, or the taking of
possession by, a receiver, custodian, trustee or liquidator of itself or of all or a
substantial part of its property, (2) is generally unable to pay its debts as they become
due, (3) makes a general assignment for the benefit of its creditors, (4) starts a
voluntary case under the federal Bankruptcy Code (as now or in the future in effect), (5)
files a petition that seeks to take advantage of any other law that provides for the relief
of debtors, (6) fails to controvert in a timely or appropriate manner, or acquiesces in
writing to, any petition that is filed against Borrower in any involuntary case under the
Bankruptcy Code or (7) takes any action for the purpose of effecting any of the foregoing.

          I. If a proceeding or case is started in any court of competent jurisdiction and is
not dismissed within 60 days, seeking (1) the liquidation, reorganization, dissolution,
winding up or composition or readjustment of Borrower or its assets or the appointment of a
trustee, receiver, custodian, liquidator or the like of Borrower or of all or any
substantial part of the assets of Borrower or (2) similar relief in respect of Borrower
under any law that provides for the relief of debtors; or if an order for relief against
Borrower is entered in an involuntary case under the Bankruptcy Code.

     9.2 If an Event of Default that is described in subsections 9.1A through 9.1G above occurs,
then, at the option of Lender, Lender’s obligation to make or renew Revolving Credit Loans shall
terminate, and all or any part of the unpaid principal balance of and accrued interest on all
Lender Indebtedness shall become immediately due and payable, without presentment, demand or notice
of any kind, all of which Borrower waives.

     9.3 If an Event of Default that is described in subsection 9.1H or 9.11 above occurs, then
Lender’s obligation to make or renew Revolving Credit Loans shall immediately terminate, and the
entire unpaid principal balance of and accrued interest on all outstanding Lender Indebtedness
shall automatically become due and payable without presentment, demand or notice of any kind, all
of which Borrower waives.

- 14 -

 

SECTION 10. CONDITIONS PRECEDENT.

          The obligation of Lender to make the initial Revolving Credit Loan is subject to the following
conditions precedent:

     10.1 Lender shall have received copies of resolutions of the Board of Directors of Borrower,
certified by the Secretary of Borrower as being in full force and effect on the date of making the
loans, authorizing Borrower’s signing, delivery and performance of this Agreement and all other
Loan Documents.

     10.2 Lender shall have received a copy of Borrower’s bylaws, including all amendments to them,
certified by the Secretary of Borrower as being in full force and effect on the date of making the
Loans.

     10.3 Lender shall have received copies of the articles of incorporation of Borrower, including
all amendments to them, certified by the Michigan Department of Labor and Economic Growth not more
than 30 days before the initial extension of loans under this Agreement.

     10.4 Lender shall have received a good standing certificate with respect to Borrower from the
Michigan Department of Labor and Economic Growth dated not more than 30 days before the initial
extension of loans under this Agreement.

     10.5 Borrower shall have signed and delivered to Lender all Loan Documents.

     10.6 Borrower shall have delivered to Lender evidence satisfactory to Lender that Borrower has
obtained the insurance policies that this Agreement and any Collateral Documents require.

     10.7 There shall not have occurred and be continuing any Default or Event of Default.

     10.8 Borrower shall have paid to Lender a processing fee in the amount of $425 as required by
Section 11.2.

SECTION 11. MISCELLANEOUS.

     11.1 Borrower shall pay, or reimburse Lender for, all out-of-pocket expenses that Lender
incurs (including, but not limited to, recording and filing fees and taxes, search fees, title
insurance premiums and actual fees and expenses of legal counsel, other professional advisers,
consultants and experts) in connection with (1) the negotiation, preparation and signing of the
Loan Documents, any amendments to, or waivers of any provisions of, the Loan Documents and any
refinancing or restructuring of any Lender Indebtedness, (2) the administration of this Agreement
and the other Loan Documents, including, without limitation, making filings and recordings in
public offices to perfect or give notice of liens in favor of Lender, obtaining policies of title
insurance, title searches, financing statement searches, tax lien searches,

- 15 -

 

appraisals and environmental inspections, audits and assessments, (3) obtaining advice of counsel
or other professional advisers, consultants and experts regarding any aspect of the Loan Documents
or any Lender Indebtedness, (4) the enforcement of any of the provisions of the Loan Documents, (5)
the collection of any Lender Indebtedness and (6) the foreclosure of any security interests,
mortgages, or other liens that at any time secure any Lender Indebtedness.

     11.2 Upon signing of this Agreement, Borrower shall pay to Lender a nonrefundable processing
fee in the amount of $425.

     11.3 Borrower acknowledges that Lender has and shall have the right to set off any
indebtedness that Lender from time to time owes to Borrower, including, without limitation, any
indebtedness that is represented by any deposit account that Borrower maintains with Lender,
against any indebtedness that is at any time due and payable by Borrower to Lender.

     11.4 Each right and remedy that this Agreement or any other Loan Document grants to Lender or
that the law allows to Lender shall be cumulative, and Lender may exercise it from time to time.
Lender’s failure to exercise, and Lender’s delay in exercising, any right or remedy shall not be a
waiver of that right or remedy or a waiver of any other right or remedy. This Agreement may not be
amended and a provision of it may not be waived except by a writing that Lender signs.

     11.5 The relationship between Borrower and Lender under this Agreement and the other Loan
Documents is solely that of debtor and creditor. Lender does not have any fiduciary
responsibilities to Borrower. Lender does not and shall not have any responsibility to review, or
to inform Borrower of any matter in connection with, any aspect of Borrower’s business, operations
or properties. Borrower shall rely entirely upon its own judgment with respect to its business and
properties. Any review, appraisal, audit, survey, inspection, report or other information that
Lender obtains, whether or not Borrower pays for it or Lender furnishes it to Borrower (“Lender
Information”), is solely for the benefit of Lender. Neither Borrower nor any third party is
entitled to rely on any Lender Information. Lender does not have any duty to Borrower with respect
to any Lender Information, including, without limitation, any duty to assure that any review,
audit, survey, inspection or appraisal is performed properly or any duty to disclose to Borrower
any facts, information, opinions, conclusions or statements that any review, audit, survey,
inspection, appraisal or other Lender Information contain.

     11.6 Any and all information provided to Lender by Borrower or any of its Affiliates shall be
subject to the non-disclosure and other obligations of Lender under the terms of the Nondisclosure
Agreement. Borrower authorizes Lender to furnish to any Affiliate of Lender and to any prospective
transferee of, or participant in, any Loan or Loans any or all information about Borrower,
including, without limitation, financial statements and information regarding the operations,
assets and properties, finances, strategies, plans, activities, transactions, owners, directors,
officers, employees and customers of Borrower and its Affiliates, if, in each case, the Affiliate
or any other prospective transferee or participant acknowledges in writing that it shall be subject
to the Nondisclosure Agreement as though an original party named in it and such obligations shall
be enforceable by Borrower directly against such Person.

- 16 -

 

     11.7 This Agreement and the rights and obligations of the parties under it shall be governed
by and interpreted in accordance with the internal laws of the State of Michigan.

     11.8 Any notice or other communication that this Agreement requires or permits shall be in
writing and shall be served either personally or by certified United States mail with postage fully
prepaid, or by a nationally-recognized, overnight courier service, addressed to Borrower as:

BIOPORT CORPORATION

3500 North Martin Luther King, Jr. Blvd.

Lansing, Michigan 48906

Attention: Robert Kramer, President

With a copy to: Jose Ochoa, General Counsel

and to Lender as:

FIFTH THIRD BANK

2501 Coolidge Road

East Lansing, Michigan 48813

Attention: Michael Debri

or to any other place that either party designates by written notice to the other party.

     11.9 This Agreement shall be binding upon and shall inure to the benefit of Borrower and
Lender and their respective successors and assigns. No Person is a third party beneficiary of this
Agreement.

     11.10 This Agreement amends and restates in its entirety the Loan Agreements between the
parties dated July 25, 2003, July 30, 2004 and October 8, 2004.

[The remainder of this page is intentionally left blank.]

- 17 -

 

     LENDER AND BORROWER EACH IRREVOCABLY AND UNCONDITIONALLY WAIVES ITS RIGHT TO A TRIAL BY JURY
IN ANY ACTION, INCLUDING ANY CLAIM, COUNTERCLAIM, CROSS-CLAIM OR THIRD-PARTY CLAIM (“CLAIM”) THAT
IS BASED UPON, ARISES OUT OF OR RELATES TO THIS LOAN AGREEMENT OR THE LENDER INDEBTEDNESS,
INCLUDING, WITHOUT LIMITATION, AND CLAIM THAT IS BASED UPON, ARISES OUT OF OR RELATES TO ANY ACTION
OR INACTION OF LENDER IN CONNECTION WITH ANY ACCELERATION OF THE INDEBTEDNESS OR ANY ENFORCEMENT OF
ANY SECURITY THAT LENDER AT ANY TIME HAS FOR ANY LENDER INDEBTEDNESS.

     Borrower and Lender have signed this Agreement as of the date stated on the first page of this
Agreement.

	 	 	 	 	 	 	 	 	 	 	 
	ATTEST:	 	 	 	BIOPORT CORPORATION
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	By	 	/s/ Robert G. Kramer
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	Its
	 	President & CEO
	 

	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	And by	 	/s/ Ronald S. Huben
	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	Its
	 	Associate Director of Finance
	 

	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	FIFTH THIRD BANK
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	By	 	/s/ Michael Debri
	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	Michael Debri
	 

	 	 	 	 	 	 	 	Its
	 	Vice President
	 
	 	 	 	 	 	 	 	 	 	 

- 18 -

 

Schedule 2.12

Plans

[Unavailable]

 

 

Schedule 2.16

Affiliates

[Unavailable]

 

 

April 25, 2006

Patrick Saam, Controller

Bioport Corporation

3500 North Martin Luther King Jr. Blvd.

Lansing, MI 48906

Dear Mr. Saam,

This letter is to inform you that the bank has extended your ten million dollar line of credit for
90 days to expire August 1, 2006. All terms and conditions remain the same. If you have any
questions, please feel free to call me at (517) 351-5204.

Sincerely,

/s/ David S. Flower

David S. Flower

Vice President

Fifth Third Bank

 

 

AMENDMENT TO AMENDED AND RESTATED LOAN AGREEMENT

     THIS AMENDMENT TO AMENDED AND RESATED LOAN AGREEMENT is made as of August 1, 2006, by and
between BIOPORT CORPORATION, a Michigan corporation, of Lansing, Michigan (“Borrower”), and FIFTH
THIRD BANK, a Michigan banking corporation, which has an office in East Lansing, Michigan
(“Lender”).

     Borrower and Lender are parties to an Amended and Restated Loan Agreement dated as of July 29,
2005, under which Lender agreed to extend to Borrower revolving credit loans of up to $10 million
in the aggregate at any time outstanding (“Loan Agreement”).

     Lender and Borrower agree to amend the Loan Agreement and, among other things, add a financial
ratio provided under a prior agreement as follows:

     1. Each capitalized term that this Amendment uses but does not define has the meaning that the
Loan Agreement gives it.

     2. Borrower adopts and restates all of the warranties and representations set forth in the
Loan Agreement and the other Loan Documents, other than the warranties and representations
contained in Sections 2.5, 2.12 and 2.16 of the Loan Agreement, as fully as though Borrower had
made them on the date of this Amendment.

     3. Lender shall discharge the two mortgages referred to in Section 5.3 of the Loan Agreement.

     4. Section 1 of the Loan Agreement shall be and is amended, effective immediately, by adding
the following definitions:

     “’Liabilities’ means all liabilities that GAAP requires to be
classified as liabilities on a balance sheet of Borrower.”

     “‘Stockholders’ Equity’ means, at any time, the sum of the
following accounts set forth in a balance sheet of Borrower, prepared in
accordance with GAAP: (1) the par or stated value of all outstanding
capital stock, (2) capital surplus and (3) retained earnings.”

     “‘Tangible Net Worth’ means, at any time, Stockholders’ Equity,
less the sum of (1) goodwill, including any amounts, however designated
on a balance sheet of Borrower, representing the excess of the purchase
price that Borrower paid for assets or stock acquired over the value
assigned to the stock or assets on Borrower’s books, (2) patents,
trademarks, trade names and copyrights, (3) treasury stock, (4) loans
and advances to shareholders, directors, officers or employees, (5)
prepaid expenses and, (6) other intangible assets.”

     5. Section 3.6 of the Loan Agreement shall be and is amended, effective immediately, to read
as follows:

 

 

     “3.6 Unless it is sooner terminated or Lender extends it in
writing, Lender’s obligation to make or to renew Revolving Credit Loans
shall expire on October 1, 2006. If Lender extends it, then Lender’s
obligation to make or renew Revolving Credit Loans shall expire on the
date stated in the extension. If Lender’s obligation to make or renew
Revolving Credit Loans expires, then the aggregate unpaid principal
balance of all outstanding Revolving Credit Loans, together with all
accrued interest on them, shall be due and payable in full on the
expiration date.”

     6. Section 6.4 of the Loan Agreement shall be and is amended, effective immediately, to read
as follows:

     “6.4 Furnish to Lender within 45 days after the end of each fiscal
quarter of Borrower, beginning with the quarter ended June 30, 2006, an
unaudited financial report, the accuracy of which is certified to by the
President or chief financial officer of Borrower, prepared in accordance
with GAAP, containing Borrower’s balance sheet as of the end of the
period and its income statement showing the results of its operations
for the portion of its fiscal year then elapsed.”

     7. The Loan Agreement is amended, effective immediately, by adding a new Section
6.12 reading as follows:

     “6.12 Maintain a ratio of total Liabilities to Tangible Net Worth
of not more than 2.5 to 1.0.”

     8. Except as expressly amended by this Amendment, all of the provisions of the Loan Agreement
are ratified and confirmed.

     Borrower and Lender have executed this Amendment as of the date stated in the first paragraph.

	 	 	 	 	 	 	 	 	 
	 	 	BIOPORT CORPORATION	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	By	 	/s/   Robert G. Kramer	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	Its
	 	President and CEO	 	 
	 

	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	And by Patrick D. Saam	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	Its
	 	Controller	 	 
	 

	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	FIFTH THIRD BANK	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	By	 	/s/   Mark Conn	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	Its
	 	Vice President	 	 
	 

	 	 	 	 	 	 	 	 

2

 

AMENDMENT TO LOAN DOCUMENTS 

     AMENDMENT (this “Agreement"), dated as of August 25, 2006, by and among FIFTH THIRD BANK, a
Michigan banking corporation (“Lender") and BIOPORT CORPORATION, a Michigan corporation
(“Borrower").

RECITALS

     A. Borrower and Lender are parties to an Amended and Restated Loan Agreement, dated as of July
29, 2005, under which Lender agreed to extend to Borrower revolving credit loans of up to $10
million in the aggregate (“Revolver Loan Agreement”) and to secure Borrower’s obligations under the
Revolver Loan Agreement, Borrower and Lender entered into an Amended and Restated Security
Agreement, dated as of July 29, 2005 (the “General Security Agreement”), which security agreement
is still in effect, and two mortgages, each dated as of July 30, 2004, granting Lender first
priority liens against certain real estate owned by Borrower, which mortgages have been released by
Lender pursuant to an Amendment, dated August 1, 2006, to the Revolver Loan Agreement and the
related documents, by and between Lender and Borrower.

     B. In addition, Borrower made an unrelated $2,400,000 Term Note on August 10, 2004 for the
benefit of Lender (the “Term Note”) and Borrower and Lender entered into a Security Agreement,
dated as of August 10, 2004, securing Borrower’s payment of the Term Note (the “Term Note Security
Agreement”).

     C. HSBC Realty Credit Corporation (USA) (“HSBC”) has agreed to make certain loans to the
Borrower and in connection therewith, HSBC and Lender have agreed to enter into an Intercreditor
Agreement, to be dated as of August 25, 2006 and acknowledged and consented to by the Borrower and
Emergent BioSolutions Inc. (as Guarantor) (the “Intercreditor Agreement”), pursuant to which Lender
and HSBC agree upon their various rights and remedies with respect to the assets of the Borrower
securing their respective indebtedness.

     D. In connection with the incurrence of the HSBC Indebtedness (as such term is defined in the
Intercreditor Agreement), Borrower and Lender desire to amend certain provisions of the Revolver
Loan Agreement and the Term Note, to terminate the Term Note Security Agreement and to update
certain schedules delivered in connection with the Term Note.

     NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, the
parties hereto agree as follows:

Article I.      Revolver Loan Agreement

     Section 1.01 The following definition shall be inserted in its entirety:

“ “Intercreditor Agreement” means the Intercreditor Agreement, dated as of
August 25, 2006, by and among HSBC Credit Realty Corporation

 

 

(USA) and the Lender, and acknowledged and consented to by the Borrower and
Emergent BioSolutions Inc.”

     Section 1.02 The definition of “Collateral” shall be changed to read as follows:

“ “Collateral” means all of Borrower’s right, title and interest in, to and
under (a) all accounts (as defined in the Uniform Commercial Code in effect
as of the date hereof in the applicable state) that Borrower now owns and in
the future acquires, including, without limitation, all Government
Contracts, (b) the Enterprise Resource Planning System, together with all
documents related to the installation and operation of it and (c) all
proceeds of the foregoing and all books, records (including computer
software) and documents that at any time evidence or relate to any of the
foregoing or any proceeds of the foregoing.”

     Section 1.03 The following definition shall be inserted in its entirety:

“ “Enterprise Resource Planning System” means a software system that
integrates departments and functions across the organization and automates
tasks involved in performing business processes. The ERP system was
licensed from SAP and is supported with, and includes, specific hardware
primarily purchased from Dell.”

     Section 1.04 The definition of “Government Contracts” shall be changed to read as follows:

“ “Government Contracts” means (1) Contract No. W9113M-04-D-0002, dated
January 3, 2004, between U.S. Army Space and Missile Defense Command (“DOD”)
and Borrower, which provides for Borrower to sell to DOD, and for DOD to
purchase form Borrower, anthrax vaccine, as it has been and in the future is
amended, (2) Contract No. 200-2005-11811 (amended to be designated Contract
No. HHS0100200600019C), dated May 5, 2005, between the Department of Health
and Human Services (“HHS”) and Borrower, which provides for Borrower to sell
to HHS, and for HHS to purchase from Borrower, anthrax vaccine, as it has
been and in the future is amended, and (3) each other contract that Borrower
at any time enters into with DOD or HHS or any other state or federal
government agency or department and that provides for Borrower to sell goods
and/or services to the government agency or department.”

     Section 1.05 The definition of “Permitted Lien” is hereby deleted in its entirety and the
following language shall be inserted in its place:

“ “Permitted Lien” means (1) a security interest, mortgage or other lien in
favor of Lender, (2) a lien for taxes that are not delinquent or, in a
jurisdiction where payment of taxes is abated during the period of any

2

 

contest, being contested in good faith by appropriate proceedings, if
adequate reserves for it have been set aside on Borrower’s books, in
accordance with GAAP, (3) a lien or encumbrance that is described on
Borrower’s balance sheet dated December 31, 2004, that Borrower has
delivered to Lender, (4) an inchoate materialmen’s, mechanics’, workmen’s,
repairmen’s or other like lien arising in the ordinary course of business,
if the obligation secured is not delinquent or is being contested in good
faith by appropriate proceedings, if adequate reserves for it have been set
aside upon Borrower’s books in accordance with GAAP and if the lien does not
jeopardize any Collateral and does not have a Material Adverse Effect, and
(5) the HSBC Liens (as such term is defined in the Intercreditor
Agreement).”

     Section 1.06 Section 5.3 of the Revolver Loan Agreement is hereby deleted in its entirety and
the following language shall be inserted in its place:

“5.3 Borrower shall sign and deliver to Lender all financing statements,
assignments, and other documents, agreements and instruments in connection
with the perfection or priority of the security in the Collateral, and shall
take all further actions that Lender reasonably requests in connection with
the perfection or priority of the security in the Collateral.”

     Section 1.07 Section 6.5 of the Revolver Loan Agreement is hereby deleted in its entirety and
the following language shall be inserted in its place:

“6.5 (1) Maintain insurance, including, but not limited to, fire, and
extended coverage insurance, worker’s compensation insurance and
commercial and general liability insurance with responsible insurance
companies on its properties and against the risks and in the amounts
and in the manner consistent with Borrower’s current practice; (2)
furnish to Lender upon request the details with respect to that
insurance and satisfactory evidence of that insurance coverage. Each
insurance policy that this Section requires shall be written or
endorsed in a manner that makes losses, if any, payable to Borrower
and Lender to the extent their respective interests appear and shall
include, where appropriate, lender’s loss payable endorsement in favor
of Lender to the extent its interests shall appear, in such form and
substance reasonable satisfactory to Lender.”

     Section 1.08 Section 7.2 of the Revolver Loan Agreement is deleted in its entirety and the
following language shall be inserted in its place:

“7.2 Sell, lease or otherwise dispose of any of the Collateral.”

3

 

     Section 1.09 Section 7.8 of the Revolver Loan Agreement is hereby deleted in its entirety and
the following language shall be inserted in its place:

“7.8 Issue, incur, assume or permit to remain outstanding any Indebtedness
that is not Subordinated Indebtedness, other than (1) Lender Indebtedness,
(2) the HSBC Indebtedness (as such term is defined in the Intercreditor
Agreement), and (3) other Indebtedness that does not exceed $500,000 in the
aggregate at any time outstanding.”

     Capitalized terms used in this Article I, and not defined herein, shall have the meanings
assigned to such term in the Revolver Loan Agreement.

Article II.      Term Note

     Section 2.01 Section 5(h) of the Term Note is deleted in its entirety and the following
language shall be inserted in its place:

“(h) Subsidiaries and Partnerships. Borrower has no subsidiaries and
is not a party to any partnership agreement or joint venture agreement.”

     Section 2.02 Section 6(c) of the Term Note is hereby deleted in its entirety and the following
language shall be inserted in its place:

“(c) At its own cost, Borrower shall obtain and maintain insurance
against (a) loss, destruction or damage to its properties and
business in the kinds and amounts customarily insured against by
corporations with established reputations engaged in the same or
similar business as Borrower and, in any event, sufficient to fully
protect Lender’s interest in the Collateral and (b) insurance against
public liability and third party property damage of the kinds and in
the amounts customarily insured against by corporations with
established reputations engaged in the same or similar business as
Borrower. All such policies shall (i) be issued by financially sound
and reputable insurers, (ii) to the extent Lender’s interests shall
appear, name Lender as additional insured and, where applicable, as
loss payee under a lender loss payable endorsement satisfactory to
Lender, and (iii) shall provide for thirty (30) days written notice
to Lender before such policy is altered or cancelled. All of the
insurance policies required hereby shall be evidenced by one or more
Certificates of Insurance delivered to Lender by Borrower on the
Closing Date and at such other times as Lender may request from time
to time.”

     Section 2.03 Schedule B (Litigation), Schedule C (Permitted Liens) and Schedule
D (Subsidiaries, Partnerships and Joint Ventures) to the Term Note are each hereby deleted and

4

 

replaced in their entirety with the Revised Schedule B, Revised Schedule C and
Revised Schedule D, respectively, attached to this Agreement.

     Capitalized terms used in this Article II, and not defined herein, shall have the meanings
assigned to such term in the Term Note.

Article III.     Security Agreement

     Section 3.01 The Term Note Security Agreement is terminated in its entirety.

     Section 3.02 Paragraph 1. of the General Security Agreement is amended to read as follows:

“1. Grant of Security Interest. Debtor grants to Secured Party a
continuing security interest in all of Debtor’s right, title and
interest in, to and under (a) all accounts (as defined in the Uniform
Commercial Code in effect as of the date hereof in the applicable
state) that Debtor now owns and in the future acquires, including,
without limitation, all Government Contracts and all amounts at any
time owing to Debtor under a Government Contract, (b) the Enterprise
Resource Planning System, together with all documents related to the
installation and operation of it and (c) all proceeds of the
foregoing and all books, records (including computer software) and
documents that at any time evidence or relate to any of the foregoing
or any proceeds of the foregoing, (collectively called “Collateral”).
In this Agreement, “Government Contracts” means (1) Contract No.
W9113M-04-D-0002, dated January 3, 2004, between U.S. Army Space and
Missile Defense Command (“DOD”) and Borrower, which provides for
Borrower to sell to DOD, and for DOD to purchase from Borrower,
anthrax vaccine, as it has been and in the future is amended, (2)
Contract No. 200-2005-11811 (amended to be designated Contract No.
HHSO100200600019C), dated May 5, 2005, between Department of Health
and Human Services (“HHS”) and Borrower, which provides for Borrower
to sell to HHS, and for HHS to purchase from Borrower, anthrax
vaccine, as that Contract has been and is in the future amended and
(3) each other contract that Debtor at any time enters into with DOD
or HHS or any other state or federal government agency or department
and that provides for Debtor to sell goods and/or services to
government agency or department. In this agreement, “Enterprise
Resource Planning System” means a software system that integrates
departments and functions across the organization and automates tasks
involved in performing business processes. The ERP system was
licensed from SAP and is supported with, and includes, specific
hardware primarily purchased from Dell.”

5

 

Article IV.      Miscellaneous

     Section 4.01 Except as expressly provided in this Agreement, all of the provisions of the Term
Loan Agreement, the Term Note and the General Security Agreement are ratified and confirmed, and
the amendments contained herein shall only apply to the provisions specifically named herein.

     Section 4.02 This Agreement when duly executed and delivered by the parties will constitute
the valid and binding obligations of each of them.

     Section 4.03 This Agreement shall be binding upon and inure to the benefit of the parties
hereto and their respective successors and assigns.

     Section 4.04 This Agreement, the Revolver Loan Agreement, the General Security Agreement, the
Intercreditor Agreement, the Term Note, all the schedules and exhibits hereto and thereto, and all
amendments and modifications to the same entered into prior to the date hereof constitute the
entire agreement among the parties with respect to its subject matter.

     Section 4.05 This Agreement may be executed in several counterparts, each of which shall be
deemed an original, but all of which, when taken together, shall constitute one and the same
document.

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

6

 

     Borrower and Lender have executed this Agreement as of the date stated in the first paragraph.

	 	 	 	 	 	 	 	 	 
	 	 	BIOPORT CORPORATION
	 
	 	 	 	 	 	 	 	 
	 	 	By	 	/s/ R. Don Elsey	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	     Its
	 	Treasurer	 	 
	 

	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	And by	 	/s/ Daniel J. Abdun-Nabi	 	 
	 	 	 	 	 	 	 
	 

	 	 	 	Its
	 	Secretary	 	 
	 

	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	FIFTH THIRD BANK
	 
	 	 	 	 	 	 	 	 
	 	 	By	 	/s/ Mark D. Conn	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	     Its
	 	Vice President	 	 
	 

	 	 	 	 	 	 	 	 

7

 

Revised Schedule B — Litigation (as of August 14, 2006)

Anthrax Vaccine Product Liability Matters 

	1.	 	Adamus v. BioPort Corp., Emergent BioSolutions, Inc., and Antex Corp. (sic), No. 05-CV-6759
(N.D. Ill.) (filed October 14, 2005) (BioPort’s MTD/to transfer pending.)

	2.	 	Emery v. BioPort Corp., No. CV-06-0008-AAM (E.D. Wash.) (filed January 9, 2006) (BioPort’s
MTD/to transfer pending.)

	3.	 	Savage v. BioPort, Inc. (sic), No. 1:06CV00081 (D.D.C.) (filed January 17, 2006) (BioPort’s
MTD/to transfer pending.)

Thimerosal Product Liability Matters (BioPort is one of numerous defendants.)

California State Court (pending in Los Angeles)

	1.	 	Allen v. Abbott Laboratories, et al., No. 02CC00108 (filed April 26, 2002) (BioPort has not
been served.)

	2.	 	Mays v. Abbott Laboratories, et. al. No. 266529 (BioPort has not been served.)

	3.	 	Schmuck v. Abbott Laboratories, et al., No. BC 2552268 (filed August 1, 2001)

	4.	 	Werley v. Abbott Laboratories, et al., No. 787422 (filed April 25, 2002) (BioPort has not
been served.)

Illinois State Court (Reilly in Cook County; all others in Madison County)

1. Barkwell v. Abbott Laboratories, et al., No. 02-L-845 (filed June 13, 2002)

2. Choate v. Abbott Laboratories, et al., No. 02-L-844 (filed June 13, 2002)

3. Conrick v. Abbott Laboratories, et al., No. 02-L-843 (filed June 13, 2002)

4. Curia v. Abbott Laboratories, et al., No. 02-L-842 (filed June 13, 2002)

5. Curia (Christopher) v. Abbott Laboratories, et al., No. 02-L-1593 (filed December 2, 2002)

6. Delghingaro v. Abbott Laboratories et al., No. 02-L-1344 (filed September 30, 2002)

7. Fredericks v. Abbott Laboratories, et al., No. 03-L-1037 (filed July 23, 2003)

8. Gabor v. Abbott Laboratories, et al., No. 02-L-1345 (filed September 30, 2002)

9. Goodman v. Abbott Laboratories, et al., No. 02-L-641 (filed May 7, 2002)

10. Guinn v. Abbott Laboratories, et al., No. 02-L-841 (filed June 13, 2002)

11. Haderlein v. Abbott Laboratories, et al., No. 04-L-1253 (filed November 10, 2004)

12. Hornstein v. Abbott Laboratories, et al., No. 02-L-642 (filed May 7, 2002)

13. Howard v. Abbott Laboratories, et al., No. 02-L-1487 (filed November 4, 2002)

14. Kramer v. Abbott Laboratories, et al., No. 03-L-670 (filed May 22, 2002)

15. Livi v. Abbott Laboratories, et al., No. 02-L-643 (filed April 30, 2002)

16. Mahnke v. Abbott Laboratories, et al., No. 02-L-1594 (filed December 12, 2002)

17. Miller v. Abbott Laboratories, et, al., No 04-L-443 (filed May 25, 2004)

18. Miller (II) v. Abbott Laboratories, et al., No. 04-L-650 (filed June 18, 2004)

19. Owczarzak v. Abbott Laboratories, et al., No-L-840 (filed June 13, 2002)

20. Panek (Nicholas) v. Abbott Laboratories, et al., No. 05-L-624 (filed July 13, 2005)

21. Panek (Brandon) v. Abbott Laboratories, et al., No. 05-L-623 (filed July 13, 2005)

8

 

22. Peterman v. Abbott Laboratories, et al., No. 04-L-0443 (filed April 1, 2004)

23. Prohaska v. Abbott Laboratories, et al., No. 04-L-1065; (filed September 28, 2004)

24. Robinson v. Abbott Laboratories, et al., No. 02-L-1346 (filed September 30, 2002)

25. Sexton v. Abbott Laboratories, et al., No. 03-L-1971 (filed December 5, 2003)

26. Spaetzel v. Abbott Laboratories, et al., No. 03-L-1972 (filed December 5, 2003)

27. Strohbeck v. Abott Laboratories, et al., No. 03-L-93 (filed January 27, 2003)

28. Sullivan v. Abbott Laboratories, et al., No. 04-L-1393 (filed December 17, 2004)

29. Sumner v. Abbott Laboratories, et al., No. 04-L-442 (filed May 25, 2004)

30. Thomason v. Abbott Laboratories, et al., No. 02-L-896 (filed June 26, 2002)

31. Trocke v. Abbott Laboratories, et al., No. 02-L-1486 (filed November 4, 2002)

32. Vaselopulos v. Abbott Laboratories, et al., No. 03-L-1176 (filed August 25, 2003)

33. Villareal v. Abbott Laboratories, et al., No. 04-L-180 (filed February 23, 2004)

34. Weider v. Abbott Laboratories, et al., No. 03-L-1559 (filed November 19, 2003)

35. Weider (II) v. Abbott Laboratories, et al., No. 04-L-181 (filed February 23, 2004)

36. Zezulak v. Abbott Laboratories, et al., No. 03-L-1175 (filed August 25, 2003)

	37.	 	Reilly v. Laboratories, et al., No. 02-L-14697 (Cook County) (filed November 20, 2002)
(dismissed April 2006; appeal pending)

Miscellaneous Litigation

	1.	 	Pandey v. Giri, et al., United States District Court for the District of Massachusetts, Civil
Case No. HDCV2006-00529 (Emergent BioSolutions named as a defendant in action where plaintiff
alleges that employee of Emergent and his wife misled him in connection with potential
marriage of individual defendants’ niece to son of plaintiff.)

9

 

Revised Schedule C — Permitted Liens

HSBC Liens (as such term is defined in the Intercreditor Agreement) and the below:

BIOPORT CORPORATION

DEBT SUMMARY &

OPERATING LEASES

AS OF JULY 31, 2006

	 	 	 	 	 	 	 
	 	 	 	 	UNPAID PRINCIPAL &	 	 
	 	 	 	 	INTEREST	 	 
	CREDITOR	 	DESCRIPTION	 	AS OF JULY 31, 2006	 	COLLATERAL
	GMAC
	 	2002 CHEVROLET VENTURE MINIVAN	 	$6,741	 	2002 CHEVROLET VENTURE MINIVAN
	LEXUS FINANCIAL SERVICES
	 	2004 LEXUS E330	 	$24,990	 	2004 LEXUS E330
	BOBCAT FINANCIAL
	 	 	 	 	 	 
	SERVICES
	 	INGERSOL BOBCAT	 	$546	 	INGERSOL BOBCAT
	IMAGISTICS
	 	 	 	 	 	 
	(rolled up of Pitney
Bowes operating leases)
	 	COPIERS & FAX MACHINES	 	$225,500	 	COPIERS & FAX MACHINES
	 
	 	 	 	 	 	 
	 
	 	 	 	 	 
	 
	 	TOTAL DEBT	 	$257,777	 	 
	 
	 	 	 	 	 

 

 

Revised Schedule D — (Subsidiaries, Partnerships and Joint Ventures)

None.

2

 

THIRD AMENDMENT TO AMENDED

AND RESTATED LOAN AGREEMENT

     THIS THIRD AMENDMENT TO AMENDED AND RESTATED LOAN AGREEMENT is made as of October 1, 2006, by
and between BIOPORT CORPORATION, a Michigan corporation, of Lansing, Michigan (“Borrower”) and
FIFTH THIRD BANK, a Michigan banking corporation, which has an office in East Lansing, Michigan
(“Lender”).

     Borrower and Lender are parties to an Amended and Restated Loan Agreement dated as of July 29,
2005, as amended on August 1, 2006 and August 25, 2006, under which Lender agreed to extend to
Borrower revolving credit loans of up to $10 million in the aggregate at any time outstanding
(“Loan Agreement”).

     Lender and Borrower agree as follows:

     1. Each capitalized term that this Amendment uses but does not define has the meaning that the
Loan Agreement gives it.

     2. Borrower adopts and restates all of the warranties and representations set forth in the
Loan Agreement and the other Loan Documents, other than the warranties and representations
contained in Sections 2.5, 2.12 and 2.16 of the Loan Agreement, as fully as though Borrower had
made them on the date of this Agreement.

     3. Section 3.6 of the Loan Agreement shall be and is amended, effective immediately, to read
as follows:

               “3.6 Unless it is sooner terminated or Lender extends it in writing, Lender’s
obligation to make or to renew Revolving Credit Loans shall expire on November 15, 2006. If
Lender extends it, then Lender’s obligation to make or renew Revolving Credit Loans shall
expire on the date stated in the extension. If Lender’s obligation to make or renew
Revolving Credit Loans expires, then the aggregate unpaid principal balance of all
outstanding Revolving Credit Loans, together with all accrued interest on them, shall be due
and payable in full on the expiration date.”

     4. Except as expressly amended by this Amendment, all of the provisions of the Loan Agreement,
as previously amended, are ratified and confirmed.

     Borrower and Lender have executed this Amendment as of the date stated in the first paragraph.

	 	 	 	 	 	 	 	 	 	 	 	 	 
	BIOPORT CORPORATION	 	 	 	FIFTH THIRD BANK
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	By	 	/s/ Robert G. Kramer	 	 	 	By	 	/s/ Mark Conn	 	 
	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Its President & CEO	 	 	 	Its	 	 /s/ Vice President	 	 
	 

	 	 	 	 	 	 	 	 	 	 

	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	And by

	 	 	 	/s/ Patrick D. Saam
 

	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Its Controllerexv10w34

 

Exhibit 10.34

Confidential Materials omitted and filed separately with the Securities
and Exchange Commission. Asterisks denote omissions.

PRODUCT SUPPLY AGREEMENT

BETWEEN

EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.

AND

TALECRIS BIOTHERAPEUTICS, INC.

PRODUCT SUPPLY AGREEMENT

     This Product Supply Agreement is made on June 12, 2006 (the “Effective Date”) by and between

	 	(1)	 	Emergent Product Development Gaithersburg Inc., a Delaware corporation having
offices at 300 Professional Drive, Gaithersburg, MD 20879 (“Emergent”); and
	 
	 	(2)	 	Talecris Biotherapeutics, Inc., a Delaware corporation having offices at 4101
Research Commons, 79 T.W. Alexander Drive, Research Triangle Park, NC 27709
(“Talecris”)

     (hereinafter, each of Emergent and Talecris a “Party” and, collectively, the “Parties”).

W I T N E S S E T H :

     WHEREAS, Emergent is engaged in the development of certain pharmaceutical products, including,
without limitation, vaccines and therapeutic products for the prevention and treatment of anthrax
infection;

 

 

     WHEREAS, Talecris possesses certain patented processes, technology, equipment and facilities
to manufacture clinical and commercial supply of the Finished Product (as defined below) in a
manner which complies with cGMP and Product Specifications (each as defined below);

     WHEREAS, the Parties wish, therefore, that Talecris perform the manufacture of the Finished
Product and that Talecris authorize Emergent to commercialize Finished Product without restriction;
and

     WHEREAS, Emergent is a wholly owned subsidiary of Emergent BioSolutions, Inc., a Delaware
corporation (“Parent”), and Parent desires to guarantee certain indemnification and payment
obligations of Emergent pursuant to this Agreement.

     NOW THEREFORE, in consideration of the foregoing premises, which are incorporated into and
made a part of this Agreement, and of the mutual covenants which are recited herein, the Parties
agree as follows:

ARTICLE 1 — DEFINITIONS

     When used in this Agreement, the capitalized terms listed in this Article 1 shall have the
following meanings:

	1.01	 	“Adverse Events” shall mean, with respect to the Finished Product, any adverse event
associated with the use of the Finished Product in a patient or clinical investigation,
whether or not considered drug related, including the following: an adverse event occurring in
the course of the use of the Finished Product in professional practice; an adverse event
occurring from drug overdose, whether accidental or intentional; an adverse event occurring
from drug abuse; an adverse event occurring from drug withdrawal; and any significant and
consistent failure of expected pharmacological action. Adverse Events shall include, without
limitation, any unfavorable and unintended sign (including, without limitation, an abnormal
laboratory finding), exacerbation of a pre-existing condition, intercurrent illness, drug
interaction, significant worsening of a disease under investigation or treatment, significant
failure of expected pharmacological or biological action, and/or symptom or disease temporally
associated with the use of the Finished Product, whether or not considered related to the
Finished Product. Notwithstanding anything foregoing to the contrary, with respect to the
Territory in which the Finished Product is marketed, Adverse Events shall include any
experience required to be reported to a relevant authority in any such country.
	 
	1.02	 	“Affiliate” shall mean, with respect to a Party, any business entity which directly or
indirectly controls, is controlled by, or is under common control with such Party. A business
entity shall be deemed to “control” another business entity if (a) it owns, directly or
indirectly, at least fifty percent (50%) of the issued and outstanding voting securities,
capital stock, or other comparable equity or ownership interest of such business entity, or
(b) it has the de facto ability to control or direct the management of such business entity.
If the laws of the jurisdiction in which such entity operates prohibit ownership by a Party of
fifty percent (50%) or more, “control” shall be deemed to exist at the maximum level

 

 

	 	 	of ownership allowed by such jurisdiction, provided, however, that there is a de facto
ability to direct or control its management.

	1.03	 	“Agreement” shall mean this Product Supply Agreement, including any exhibits or schedules
hereto, as such may be amended from time to time, in writing, by mutual agreement of the
Parties.
	 
	1.04	 	“AIG” shall mean Anthrax Immune Globulin derived from AIG Source Plasma.
	 
	1.05	 	“AIG specific IgG Yield” shall mean the total volume of AIG contained in AIG Source Plasma or
Processed Product (as applicable) expressed in grams per liter.
	 
	1.06	 	“AIG specific IgG Target Yield” shall have the meaning set forth in Section 4.01(c)(i).
	 
	1.07	 	“AIG Source Plasma” shall mean anthrax immune human plasma, as defined under Applicable Law,
collected by or on behalf of Emergent. AIG Source Plasma shall exclude By-Products.
	 
	1.08	 	“AIG Source Plasma Specifications” shall mean the quality and other specifications for Source
Plasma, as set forth on Exhibit C attached hereto, which specifications may be amended
from time to time by mutual agreement of the Parties.
	 
	1.09	 	“Applicable Law” shall mean any statute, law, treaty, rule, code, ordinance, regulation,
permit, interpretation, certificate or order of a government authority, or any judgment,
decision, decree, injunction, writ, order, subpoena, or like action of any court, arbitrator
or other government entity (including without limitation, requirements of the FDA and cGMP) to
the extent applicable and in each case as amended from time to time.
	 
	1.10	 	“Batch Production Record” shall mean a copy of the Master Batch Record for AIG and Finished
Product, which shall include, without limitation, instructions for manufacturing, packaging,
in-process testing and release testing for the AIG and Finished Product, as well as the actual
record of the performance of such work.
	 
	1.11	 	“BLA” shall mean a Biologics License Application filed with the FDA and/or any other
application required for the purpose of marketing or selling or using a therapeutic or
prophylactic product to be filed with a governmental agency in a non-U.S. country or group of
countries, including, without limitation, a Product License Application or Marketing
Authorization in the European Union.
	 
	1.12	 	“Business Day” shall mean Monday, Tuesday, Wednesday, Thursday or Friday of any week other
than such days on which banking institutions located in Washington, D.C. and/or Raleigh, North
Carolina are permitted or required by law, executive order or governmental decree to remain
closed.
	 
	1.13	 	“By-Products” shall mean products or materials, other than the Finished Product, that are
processed from derivative materials resulting from Talecris’ Processing of the AIG Source
Plasma into Finished Product at the Facilities hereunder.

 

 

	1.14	 	“Certificate of Analysis” shall mean a document or documents provided by Talecris to Emergent
for a batch of the Finished Product, that (a) bears the results of in-process or release
analytical testing and their respective specifications, and (b) states whether such Finished
Product was Processed in accordance with cGMP.
	 
	1.15	 	“Certificate of Conformance” shall mean a document or documents provided by Talecris to
Emergent that attests that a specific Lot of Finished Product was Processed in accordance with
cGMP.
	 
	1.16	 	“cGMP” shall mean current good manufacturing practices as set forth in Title 21, Parts 210
and 211 of the C.F.R. and 21 C.F.R. Part 312 (IND), and 21 C.F.R. Part 600, 606, 610, 630 and
640 (Biologics and Blood Products), as established and amended by the FDA, and any comparable
requirement of law in a country or group of countries other than the United States.
	 
	1.17	 	“Claim” shall mean any charge, complaint, action, suit, proceeding, hearing, investigation,
claim, controversy, dispute, demand, judgment, order, decree, stipulation, injunction, or
similar matters.
	 
	1.18	 	“Commercial Product” shall mean Finished Product for commercial use or use other than for
Pre-Commercial Product.
	 
	1.19	 	“Commercial Target Yield” shall have the meaning set forth in Section 4.01(d).
	 
	1.20	 	“Commercial Term” shall have the meaning set forth in Section 10.01(b).
	 
	1.21	 	“Commercial Volume Commitment” shall have the meaning set forth in Section 4.02(a).
	 
	1.22	 	“Commercially Reasonable Efforts” shall mean that degree of skill, effort, expertise, and
resources which a Person of ordinary skill, ability, and experience, under similar
circumstances, in the matters addressed herein would reasonably utilize and otherwise apply
with respect to fulfilling the obligations assumed hereunder.
	 
	1.23	 	“Conforming AIG Source Plasma” shall have the meaning set forth in Section 11.02(a).
	 
	1.24	 	“Contract Year” shall mean each twelve (12) month period during the Commercial Term or any
Extension Period hereunder, commencing on the effective date of the Commercial Term.
	 
	1.25	 	“Dedicated Equipment” shall consist of the equipment and associated fixtures which are used
by Talecris during the Term of this Agreement for the purpose of manufacturing the Finished
Product for Emergent hereunder.
	 
	1.26	 	“Dollar” shall mean the United States dollar.
	 
	1.27	 	“Emergent Indemnitee” shall mean Emergent, its Affiliates, its Sublicensees, and their
respective directors, officers, employees and agents.

 

 

	1.28	 	“Emergent Specifications” shall mean the specifications concerning [**] Product hereunder,
established by Emergent in its sole discretion from time to time pursuant to Section 5.04.
The initial Emergent Specifications shall be completed by Emergent as soon as practicable
following the Effective Date and attached hereto as Exhibit A-1.
	 
	1.29	 	“Evaluation Lot” shall have the meaning set forth in Section 4.01(a).
	 
	1.30	 	“Exclusivity Agreement” shall mean the exclusivity agreement between the Parties dated as of
the Effective Date, in the form attached hereto as Exhibit G.
	 
	1.31	 	“Extension Period” shall have the meaning set forth in Section 10.01(c).
	 
	1.32	 	“Facilities” shall mean the Melville, New York Precision Pharma or Clayton, North Carolina
location where fractionation shall take place, and the manufacturing facility in Clayton,
North Carolina where purification shall take place, and the real property underlying such
manufacturing facilities used by Talecris to practice the Process, together with all of the
Dedicated Equipment, but not including equipment which is not used in the Process.
	 
	1.33	 	“Facility Goods” shall mean any products manufactured at the Facilities other than the
Finished Product, including without limitation Gamunex.
	 
	1.34	 	“FDA” shall mean the United States Food and Drug Administration.
	 
	1.35	 	“Field” shall mean the prevention, treatment or therapy of anthrax infection in humans.
	 
	1.36	 	“Fill/Finish Specifications” shall mean such manufacturing specifications concerning the
[**], as the Parties may mutually agree.
	 
	1.37	 	“Finished Product” shall mean any [**] as an active ingredient.
	 
	1.38	 	“Firm Commitment” shall have the meaning set forth in Section 4.02(d).
	 
	1.39	 	“Force Majeure” shall have the meaning set forth in Section 15.11.
	 
	1.40	 	“Foreign Currency Sales” shall mean Sales which are invoiced by Emergent in a currency other
than the Dollar.
	 
	1.41	 	“Gamunex” shall mean Talecris’ immunology product marketed as Gamunex®.
	 
	1.42	 	“Gamunex Specifications” shall mean the specifications for Gamunex attached hereto as
Exhibit A, as amended by Talecris from time to time in accordance with Section 5.01.
	 
	1.43	 	“Generally Accepted Accounting Principles” shall mean generally accepted accounting
principles as set forth in opinions and pronouncements of the Accounting Principles Board of
the American Institute of Certified Public Accountants and statements and pronouncements of
the Financial Accounting Standards Board as consistently applied per usual accounting
practices.

 

 

	1.44	 	“Gross Price” shall mean, with respect to a Finished Product, the unit price, without
deduction, actually invoiced by Emergent, its Affiliates and Sublicensees for the Sale of such
Finished Product.
	 
	1.45	 	“IgG Yields” shall have the meaning set forth in Section 4.01(c)(iv).
	 
	1.46	 	“INCOTERMS 2000” shall mean the specifications of the obligations for delivering goods in
international contracts, as issued by the International Chamber of Commerce.
	 
	1.47	 	“IND” shall mean an investigational new drug application filed with the FDA and/or any other
similar application to be filed with a governmental agency in a country or group of countries
other than the United States.
	 
	1.48	 	“Initial AIG Source Plasma” shall have the meaning set forth in Section 3.01(a).
	 
	1.49	 	“Insolvency Event” shall mean the commencement of any action, whether voluntarily or
involuntarily (provided, that such involuntary action is not dismissed within ninety (90) days
of commencement thereof), seeking any relief by liquidation, reorganization (other than for
corporate reorganization), dissolution or similar act under any bankruptcy, insolvency or
similar law or otherwise any action seeking any arrangement between or with its creditors or
any commencement of a proceeding or receipt of an order, judgment or decree seeking the
liquidation, reorganization or dissolution of a Party or any other relief under any
bankruptcy, insolvency or similar law or an arrangement is made with respect to such Party’s
debts or business by its creditors.
	 
	1.50	 	“Losses” shall mean losses, deficiencies, defaults, assessments, dues, penalties, fines,
amounts paid in settlement, liabilities, obligations, taxes, liens, damages, costs and actual
out-of-pocket expenses (including interest, penalties, court costs, attorneys’ fees,
accountants and other experts, or other expenses of any Claim), including all damages
awardable pursuant to statute and treble damages.
	 
	1.51	 	“Lot” shall mean a lot of between [**] liters to [**] liters of AIG Source Plasma to be
Processed by Talecris in accordance with Product Specifications and cGMP (or as otherwise may
be mutually agreed by the Parties).
	 
	1.52	 	“Major Markets” shall mean the United States and Canada.
	 
	1.53	 	“Master Batch Record” shall mean the master batch record for AIG and Finished Product, which
shall include, without limitation, instructions for manufacturing, packaging, and in-process
testing and release testing for the AIG and Finished Product.
	 
	1.54	 	“Minimum Commitment Fee” shall have the meaning set forth in Section 7.05(a).
	 
	1.55	 	“Negotiation Period” shall have the meaning set forth in Section 2.03.
	 
	1.56	 	“Net Sales” shall mean the Gross Price of Finished Products multiplied by the quantity of
Finished Products Sold in the Territory, less (a) trade and quantity discounts actually
allowed and taken, (b) sales, value added, or other excise taxes paid, absorbed or allowed,

 

 

	 	 	(c) import and export taxes and such other amounts paid by Emergent, its Affiliates or
Sublicensees to a governmental entity as a result of the importing or exporting of Finished
Product, (d) amounts repaid or credited by reason of purchase chargebacks, rebates
(including rebates in kind), rejections, defects or returns (including, without limitation,
rebates pursuant to governmental and managed care programs), and (e) charges actually
incurred for insurance, handling, distribution, freight and transportation, provided that
the aggregate amount of such charges shall not exceed two percent (2%) of the total invoiced
price. All of the items set forth in (a) through (e) above shall be calculated according to
Emergent’s standard method of accounting consistently applied in accordance with Generally
Accepted Accounting Principles, and shall not in aggregate exceed fifteen percent (15%) of
the aggregate Gross Price of any Finished Product.

	 	 	If a Finished Product is Sold in the form of a Combination Product (as defined below), Net
Sales for such Combination Product will be calculated by multiplying actual Net Sales of
such Combination Product by the fraction A/(A+B) where: A is the Gross Price of the
Finished Product contained in the Combination Product if Sold separately by Emergent, its
Affiliates or Sublicensees, and B is the Gross Price of any other active component or
components in the Combination Product if sold separately by Emergent, its Affiliates or
Sublicensees. If the Finished Product is Sold in the form of a Combination Product
containing one or more active ingredients other than the Finished Product, and one or more
active ingredients of the Combination Product are not Sold separately by Emergent, its
Affiliates or Sublicensees, then the Parties shall meet and mutually agree upon a
commercially reasonable portion of such Net Sales to allocate to the Finished Product. In
no event shall less than seventy-five percent (75%) of the Net Sales for any Combination
Product be allocated to the Gross Price of the Finished Product. “Combination Product”
shall mean any pharmaceutical product, in any formulation, which comprises two (2) or more
active ingredients, at least one (1) of which is AIG (an “active ingredient” being a
biologically active ingredient which causes one (1) or more direct clinical therapeutic
effects, and excluding diluents, vehicles, drug delivery systems, adjuvants or other
ingredients which do not by themselves have such therapeutic effects).
	 
	 	 	Upon the Sale of the Finished Product other than in a bona fide arm’s length transaction
exclusively for money or upon any use, transfer or disposal of Finished Product for purposes
which do not result in sales revenue which would be expected in an arm’s length transaction
exclusively for money in the relevant country, that Sale, use, transfer or disposal shall be
deemed to constitute a Sale at the relevant open market price in the country in which the
Sale, use, transfer or disposal occurs, or if that price is not ascertainable, a reasonable
price assessed on an arm’s length basis.
	 
	1.57	 	“Non-Conforming” or “Non-Conforming Product” shall mean Finished Product which at the time of
delivery does not (and/or could not) meet the Product Specifications and cGMP. For purposes
of Section 5.02 (Quality Assurance), Section 11.04 (Remedies for Delivery of Non-Conforming
Product or Spoiled AIG Source Plasma) and Section 12.03 (Product Liability Claims), Finished
Product shall not be deemed Non-Conforming if the non-conformance results from the use of
Non-Conforming AIG Source Plasma.

 

 

	1.58	 	“Non-Conforming AIG Source Plasma” shall mean AIG Source Plasma which does not comply with
the AIG Source Plasma Specifications as of the time of delivery of such AIG Source Plasma to
Talecris.
	 
	1.59	 	“Nonspecific IgG Target Yield” shall have the meaning set forth in Section 4.01(c)(i).
	 
	1.60	 	“Nonspecific IgG Yield” shall mean the total volume of all immune globulins present in AIG
Source Plasma or Processed Product (as applicable) expressed in grams per liter.
	 
	1.61	 	“Notice” shall have the meaning set forth in Section 15.01 of this Agreement; “Notify” or any
variation thereof shall mean to provide Notice or other corresponding meaning.
	 
	1.62	 	“Order” shall mean a written order for either Pre-Commercial Product or Commercial Product.
	 
	1.63	 	“Person” shall mean any natural person or any corporation, company, sole proprietorship,
partnership, joint venture, firm or other business entity.
	 
	1.64	 	“Pre-Commercial Product” shall mean Finished Product (a) for pre-clinical or animal studies,
(b) for clinical use or for non-clinical testing required for clinical trials in preparation
for submission, approval or maintenance of a regulatory filing, including without limitation
any INDs and/or BLAs, and/or (c) necessary for Emergent to secure the first contractual
commitment for Finished Product from a Third Party and/or to obtain government funding for
Finished Product.
	 
	1.65	 	“Pre-Commercial Target Yield” shall have the meaning set forth in Section 4.01(c)(iv).
	 
	1.66	 	“Pre-Commercial Term” shall have the meaning set forth in Section 10.01(a).
	 
	1.67	 	“Process,” “Processed,” or “Processing” shall mean the act of fractionation, purification,
sterilization, virus inactivation/removal, testing, filling, finishing and any other
pharmaceutical manufacturing procedures, or any part thereof, for manufacturing the Finished
Product hereunder, consisting of activities which are required to meet the Gamunex
Specifications and, with respect to Finished Product, such other activities required to meet
the Fill/Finish Specifications.
	 
	1.68	 	“Processing Fee” shall have the meaning set forth in Section 7.03(a).
	 
	1.69	 	“Processed Product” shall mean AIG Source Plasma that has been Processed in compliance with
Gamunex Specifications but has not yet met Fill/Finish Specifications.
	 
	1.70	 	“Product Liability Claim” shall mean, with respect to any Finished Product or By-Product, as
applicable, a Claim of a Third Party (other than a Claim arising out of use of Finished
Product in a clinical trial) that (a) arises as a result of the use of such product that
results in personal injury or death or (b) is in anticipation of or intended to prevent or
forestall personal injury or death as a result of the use of such product.

 

 

	1.71	 	“Product Specifications” shall mean the (a) Gamunex Specifications, and (b) the Fill/Finish
Specifications.
	 
	1.72	 	“Quality Agreement” shall mean the agreement attached hereto as Exhibit F.
	 
	1.73	 	“Regulatory Authority” shall mean, with respect to the United States, the FDA or, in the case
of a country in the Territory other than the United States, such other appropriate regulatory
authority with similar responsibilities.
	 
	1.74	 	“Rolling Forecast” shall have the meaning specified in Section 4.02(c).
	 
	1.75	 	“Sale(s)”, “Sold” and “Sell” shall mean the sale, transfer or disposition of the Finished
Product for commercial purposes for value to a Third Party (whether an end user, wholesaler or
otherwise), whether by Emergent, its Affiliates or Sublicensees, but excluding the sale,
transfer or disposition of any Validation Lots or Pre-Commercial Product.
	 
	1.76	 	“Sublicensee” shall mean any third party (including Affiliates) to whom a sublicense has been
granted pursuant to this Agreement.
	 
	1.77	 	“Supply Failure” shall be deemed to exist with respect to any Lot of AIG Source Plasma
Processed under this Agreement to provide Finished Product to Emergent if either of the
following has occurred:

	 	(a)	 	a Lot of AIG Source Plasma Processed hereunder has a Yield of less than [**]
percent ([**]%) of the Commercial Target Yield on [**] occasions within any given
rolling twelve (12) month period.
	 
	 	(b)	 	over any given rolling (12) month period, the Lots of AIG Source Plasma
Processed hereunder have an average Yield of less than the Commercial Target Yield,
provided that any Lot described in clause (a) shall be excluded from the computation of
average Yield.

	1.78	 	“Talecris BLA sections” shall have the meaning set forth in Section 8.01(a).
	 
	1.79	 	“Talecris Gamunex Activities” shall mean those activities as defined in Section 8.01(a), as
such activities are related to Finished Product hereunder. The list of such activities under
Section 8.01 is provided for illustrative purposes only and is not intended to be a
comprehensive list.
	 
	1.80	 	“Talecris Patent Rights” shall mean Talecris’s rights in inventions and discoveries which are
related to AIG or the Finished Product and/or the Process and covered by a patent or patent
application listed on Exhibit B, all provisionals, divisions, continuations,
continuations-in-part, reissues, reexaminations or extensions thereof, and any corresponding
foreign counterparts and equivalents thereof.
	 
	1.81	 	“Term” shall have the meaning set forth in Section 10.01(c).

 

 

	1.82	 	“Territory” shall mean each country in the world.
	 
	1.83	 	“Third Party” shall mean any Person which is not a Party, an Affiliate or a Sublicensee under
this Agreement.
	 
	1.84	 	“Third Party Customer” shall mean a Third Party that is a customer of Talecris for Facility
Goods.
	 
	1.85	 	“US CPI” shall mean the U.S. consumer price index medical care commodities index for similar
goods and services published by the United States Department of Labor, Bureau of Labor
Statistics, as reported by the Wall Street Journal (Eastern Edition), or such other index as
may be mutually agreed upon by the Parties.
	 
	1.86	 	“Validation” shall mean successful validation of the Facilities, Dedicated Equipment and
critical Process steps in compliance with cGMP, including (a) the successful completion of all
validation protocols established by the Parties for the Facility and Designated Equipment, and
(b) ensuring and providing documentary evidence that the Process used by Talecris to
manufacture Finished Product is capable of consistently producing Finished Product of the
required quality as determined by the Product Specifications.
	 
	1.87	 	“Validation Lot(s)” shall mean the consistency Lot(s) necessary to obtain Validation
hereunder and that meets the Pre-Commercial Target Yield.
	 
	1.88	 	“Yield” shall mean, with respect to any Lot of AIG Source Plasma Processed under this
Agreement to provide Finished Product to Emergent, in the case of AIG specific IgG, (i) the
quantity of AIG specific IgG from Processed Product exhibited following Processing divided by
(ii) the quantity of AIG specific IgG from Source Plasma exhibited prior to Processing (“AIG
specific IgG Yield”), and, in the case of Nonspecific IgG, (i) the quantity of Nonspecific IgG
from Processed Product exhibited following Processing divided by (ii) the quantity of
Nonspecific IgG from Source Plasma exhibited prior to Processing (“Nonspecific IgG Yield”);
provided, however, that Non-Conforming Product shall not be included in the computation of
Yield.

ARTICLE 2 — SCOPE OF SERVICES AND GENERAL ARRANGEMENT

	2.01	 	Emergent Obligations. Emergent shall provide AIG Source Plasma meeting the AIG
Source Plasma Specifications to Talecris for Processing. Emergent shall pursue all necessary
regulatory approvals with regard to Finished Products with the assistance of Talecris as each
is further described in Article 8 below.
	 
	2.02	 	Scope of Talecris Services. Talecris shall, in accordance with the terms of this
Agreement:

	 	(a)	 	perform Processing services at the Facilities in accordance with the Product
Specifications and cGMP, provided, however, that during the Pre-Commercial Term the
purification and fill and finish shall be performed at the Facility in Clayton, North
Carolina;

 

 

	 	(b)	 	perform quality assurance review of the Finished Product and of the Processing
in accordance with the Product Specifications and cGMP; and
	 
	 	(c)	 	permit Emergent to perform quality assurance review of the Finished Product and
of the Processing in accordance with the Product Specifications and cGMP.

	2.03	 	Emergent [**]. If at any time during the Term Talecris [**]
Centers for Disease
Control (“CDC”) category A, B and/or C bioterrorism agents which are listed on Exhibit
J attached hereto (the “Proposal”), then Talecris
[**] Emergent [**]. If Emergent [**] Talecris [**], the Parties shall [**] in good faith for up to [**] days (or longer, upon mutual
agreement of the Parties) (“Negotiation Period”)
[**]. If the Parties are
[**] Negotiation Period, Talecris shall be [**].
	 
	2.04	 	Exclusivity. Each Party’s noncompete and/or exclusivity obligations under this
Agreement with respect to Finished Product shall be governed by the terms of the Exclusivity
Agreement.

ARTICLE 3 — SUPPLY OF AIG SOURCE PLASMA; BY-PRODUCTS

	3.01	 	Supply and Use.

	 	(a)	 	Delivery of AIG Source Plasma; Use of AIG Source Plasma. Emergent
shall (or shall cause one of its Affiliates or a designee to) deliver to Talecris (by
or on a date mutually scheduled by Talecris and Emergent) such quantity of AIG Source
Plasma which meets the AIG Source Plasma Specifications as is reasonably necessary for
Talecris to manufacture Finished Product hereunder, including without limitation an
initial pool of [**] liters (or such other amount as the Parties may mutually agree) of
AIG Source Plasma (“Initial AIG Source Plasma”). Talecris shall not procure human
plasma from sources other than Emergent, its designee(s) or Affiliates for use in
Finished Product. Talecris shall not use AIG Source Plasma, except as set forth in
Section 2.02, Section 3.04 and 4.01(e) below, for any purpose other than to supply
Finished Product to Emergent. Except as specifically set forth in Article 4 below,
Talecris shall handle, store, use and dispose of all such AIG Source Plasma at the
Facilities in compliance with Applicable Law in the Major Markets.
	 
	 	(b)	 	Processing of AIG Source Plasma. Talecris shall Process the AIG Source
Plasma in compliance with the Product Specifications and, except as set forth in
Section 4.01(e) below (Macrobench-Scale Purification), cGMP.

 

 

	3.02	 	Delivery. Within fifteen (15) Business Days following Talecris’ receipt from
Emergent of each Order for Finished Product pursuant to Article 4, Talecris shall Notify
Emergent of the scheduled date(s) for commencement of the Processing of the Finished Product
covered by such Order. Emergent shall use Commercially Reasonable Efforts to deliver or have
delivered to Talecris a sufficient quantity of AIG Source Plasma to meet Processing of the
Finished Product covered by such Order at least [**] days prior to each of Talecris’ scheduled
run date(s) for Processing of such Finished Product. Emergent acknowledges and agrees that its
failure to provide sufficient quantity of AIG Source Plasma meeting the AIG Source Plasma
Specifications on a timely basis may negatively affect Talecris’ ability to Process and
deliver the Finished Product by the delivery dates requested by Emergent.
	 
	3.03	 	Ownership of AIG Source Plasma. Emergent shall retain ownership of all right, title
and interest in and to any AIG Source Plasma.
	 
	3.04	 	By-Products. Subject to the terms and conditions of this Agreement, Talecris shall
have the right to dispose of, further manufacture, or sell any By-Products, provided that
Talecris shall not, by itself or in collaboration with or on behalf of a Third Party, develop,
manufacture, produce, promote, market, offer to sell, sell or otherwise dispose of any
By-Product for use in the Field, and By-Products shall not be generated from any unprocessed
Lot of AIG Source Plasma or portion thereof nor from any II/III paste generated therefrom.
Furthermore, Talecris shall not undertake any changes to the Process with the purpose of
increasing the quantity of By-Products at the expense of the Finished Product.

ARTICLE 4 — PRE-COMMERCIAL AND COMMERCIAL PRODUCT; FORECASTS

AND ORDERS

	4.01	 	Pre-Commercial Product.

	 	(a)	 	Evaluation Lot.
	 
	 	 	 	During the Pre-Commercial Term, Emergent shall submit to Talecris an Order for [**]
(“Evaluation Lot”). Emergent shall pay Talecris the Processing Fee for such
Evaluation Lot.
	 
	 	(b)	 	Validation Lots.
	 
	 	 	 	For purposes of calculating the Commercial Target Yield in order to determine
whether a Supply Failure has arisen pursuant to Section 4.04(a) below, Emergent
shall order at least [**] Validation Lots. The Evaluation Lot may constitute a
Validation Lot for the purposes of this Section 4.01(b). Emergent shall pay
Talecris the Processing Fee for each Validation Lot provided by Talecris.
	 
	 	(c)	 	Pre-Commercial Target Yield.

	 	(i)	 	During the Pre-Commercial Term, Talecris shall provide a
Nonspecific IgG Yield of no less than [**] percent ([**]%) (“Nonspecific IgG
Target

 

 

	 	 	 	Yield”) and a AIG specific IgG Yield of no less than [**] percent ([**]%)
(“AIG specific IgG Target Yield”).

	 	(ii)	 	In conjunction with the Processing of each Lot of
Pre-Commercial Product, Talecris shall determine the Nonspecific IgG Yield in a
manner consistent with Talecris’ customary practices.
	 
	 	(iii)	 	In conjunction with the Processing of each Lot of
Pre-Commercial Product, Emergent shall determine the AIG specific IgG Yield,
with the use of testing procedures reviewed and approved by Talecris, which
approval shall not be unreasonably withheld, delayed or conditioned.
	 
	 	(iv)	 	The Nonspecific IgG Yield and the AIG specific IgG Yield shall
collectively be referred to as the “IgG Yields.” The Nonspecific IgG Target
Yield and the AIG specific IgG Target Yields shall collectively be referred to
as the “Pre-Commercial Target Yield.”
	 
	 	(v)	 	In the event that Talecris determines that the Nonspecific IgG
Yield is less than the Nonspecific IgG Target Yield, Talecris shall Notify
Emergent of such determination and provide reasonable documentation supporting
such determination, which shall be reflective of its usual manufacturing
process and procedures. In the event that Emergent determines that the AIG
specific IgG Yield is less than the AIG specific IgG Target Yield, Emergent
shall Notify Talecris of such determination and provide reasonable
documentation supporting such determination, which shall be reflective of its
usual process and procedures.
	 
	 	     (A)	 	If the Parties agree with the determination that either the
Nonspecific IgG Yield or the AIG specific IgG Yield is less than the
respective Pre-Commercial Target Yield, Emergent shall have the right, but
not the obligation, to utilize the services of a Third Party to process
another Evaluation Lot.
	 
	 	     (1)	 	In the event that such Third Party achieves an AIG IgG specific
Yield of at least [**] percent ([**]%) greater than Talecris’ AIG specific
IgG Yield, Emergent may terminate this Agreement pursuant to Section
10.02(i) and the Exclusivity Agreement shall terminate in accordance with
the terms set forth therein.
	 
	 	     (2)	 	In the event that such Third Party does not achieve an AIG IgG
specific Yield of at least [**] percent ([**]%) greater than Talecris’ AIG
IgG specific Yield, Emergent may not sell any pharmaceutical product
processed on its behalf that contains AIG as an active ingredient from any
Third Party in accordance with the terms of the Exclusivity Agreement, and
the terms and conditions of the Exclusivity Agreement shall remain in full
force and effect.

 

 

	 	(B)	 	If either Party disagrees with the determination of the other Party
whether or not the IgG Yield is less than the Pre-Commercial Target Yield,
such Party shall Notify the other Party of such disagreement and the Parties
shall engage a mutually selected independent laboratory to make such
determination.

	 	(d)	 	Commercial Target Yield.
	 
	 	 	 	If the Parties mutually determine that the IgG Yields are equal to or greater than
the Pre-Commercial Target Yield for the Evaluation Lot (if applicable) and each of
the [**] Validation Lots, the “Commercial Target Yield” for the Commercial Term
shall be computed and determined as follows:
	 
	 	 	 	With respect to Nonspecific IgG:

	 	(i)	 	the average final quantity of Nonspecific IgG exhibited after
Processing all of the Validation Lots ordered pursuant to Section 4.01(b),
divided by
	 
	 	(ii)	 	the average initial quantity of Nonspecific IgG from the AIG
Source Plasma exhibited prior to Processing all of the Validation Lots ordered
pursuant to Section 4.01(b); and
	 
	 	(iii)	 	the quotient of which is multiplied by [**] percent ([**]%).

	 	 	 	With respect to AIG specific IgG:

	 	(i)	 	the average final quantity of AIG specific IgG exhibited after
Processing all of the Validation Lots ordered pursuant to Section 4.01(b),
divided by
	 
	 	(ii)	 	the average initial quantity of AIG specific IgG from the AIG
Source Plasma exhibited prior to Processing all of the Validation Lots ordered
pursuant to Section 4.01(b); and
	 
	 	(iii)	 	the quotient of which is multiplied by [**] percent ([**]%).

	 	 	 	Upon the completion of the Pre-Commercial Term and at the completion of each twelve
(12) month period during the Commercial Term, the Parties shall recompute the
Commercial Target Yield to include the additional Processed Lots which were not
included in the original computation set forth above. Such computation shall be
based on Yield results provided by each respective Party to the other at the end of
each period. In the event that the recomputed Commercial Target Yield more closely
resembles the historical average yields experienced by Talecris in processing
Gamunex, the Parties agree to negotiate in good faith an adjustment to the
Commercial Target Yield to reflect the processing information provided by the
additional Lots.
	 
	 	(e)	 	Macrobench-Scale Purification. Talecris shall Process a non-cGMP
macrobench-scale purification of [**] liters (or such other amount as the Parties may
mutually

 

 

	 	 	 	agree) of the Initial AIG Source Plasma Processed by Talecris hereunder, which may
be used by Emergent for proof-of-concept studies, validation of the potency release
assay for Finished Product, development activities, pre-clinical studies, and
otherwise in support of Emergent’s development efforts in connection with Finished
Product. For purposes of clarity, such macrobench-scale purification process shall
be sterile and endotoxin-free and otherwise be the same as the purification process
used in the Process, except that Talecris shall not be required to conduct such
purification under cGMP conditions.

	 	(f)	 	Additional Lots of Pre-Commercial Product. During the Pre-Commercial
Term, Emergent shall have the right, in its sole discretion, to submit to Talecris
Orders for additional Lots of Pre-Commercial Product in excess of those Ordered
pursuant to Sections 4.01(a) through 4.01(c), including without limitation Validation
Lots. Talecris shall conduct the Processing of any Lots of Pre-Commercial Product
ordered by Emergent pursuant to Sections 4.01(a) through 4.01(c) at such times as the
Parties may mutually agree; provided, however, that Talecris shall use Commercially
Reasonable Efforts to schedule the Processing of such Lots on dates which are as close
as practicable to the dates requested by Emergent in the Order(s) for such Lots.
Emergent shall pay the Processing Fee for any additional Lots of Pre-Commercial Product
ordered pursuant to this Section 4.01(f).
	 
	 	(g)	 	Non-Binding Forecast for Pre-Commercial Product. As soon as
practicable following the Effective Date of this Agreement and from time to time
thereafter during the Pre-Commercial Term, Emergent shall submit to Talecris a
non-binding, good faith forecast that sets forth the total quantity of Pre-Commercial
Product which Emergent expects to order from Talecris within the time period set forth
in such forecast. Emergent shall update such forecast from time to time but not less
frequently than annually, unless otherwise agreed by the Parties in writing, based on
its reasonable expectations and/or need for Pre-Commercial Product.
	 
	 	(h)	 	Orders for Pre-Commercial Product. Each Order for Pre-Commercial
Product shall specify the Pre-Commercial Product ordered, the quantities of the
Pre-Commercial Product ordered, the requested manner and address of delivery, and the
requested delivery date, which shall be no earlier than [**] days from the date of the
Order (unless otherwise agreed to by Talecris in writing), all of which shall be
subject to Article 6. Emergent shall submit its initial Order for Pre-Commercial
Product on the Effective Date and may submit additional Orders for Pre-Commercial
Product at any time thereafter during the Pre-Commercial Term.

	4.02	 	Commercial Product.

	 	(a)	 	Commercial Volume Commitment. Unless otherwise mutually agreed by the
Parties, the minimum annual volume commitment by Emergent (“Commercial Volume
Commitment”) for each Contract Year shall be (a) [**] liters of AIG Source Plasma per
annum to be Processed into Finished Product during the

 

 

	 	 	 	Commercial Term, and (b) [**] liters of AIG Source Plasma per annum to be Processed
into Finished Product during any Extension Period. The Commercial Volume Commitment
shall be reduced, upon the occurrence of a Supply Failure, on a prorated basis with
respect to each month in which Emergent is able to use an alternative supplier
pursuant to Section 4.04(a) below and Emergent has elected to use such an
alternative supplier.

	 	(b)	 	Process Initiation. Subject to the provisions of Section 3.02 above,
Talecris shall use Commercially Reasonable Efforts to initiate the Processing of the
Commercial Product on the date which is as close as practicable to the initial fill
date set forth in the initial Rolling Forecast submitted by Emergent under Section
4.02(c) below, but in no event later than twelve (12) months from the date of
Emergent’s Notice of its intent to initiate the Commercial Term as set forth in Section
10.01(b).
	 
	 	(c)	 	Rolling Forecast for Commercial Product. No later than thirty (30)
days following the commencement of the Commercial Term, Emergent shall submit to
Talecris an initial twelve (12) month rolling forecast (“Rolling Forecast”) that sets
forth the total quantity of Finished Product which Emergent expects to order from
Talecris within such twelve (12) month period (“Annual Forecast Amount”), with a
breakdown of the total quantity of Finished Product by month and the delivery schedule
for such Finished Product. Without Talecris’ prior written approval, the initial
Annual Forecast Amount for the first Contract Year shall not exceed [**] liters of
Finished Product, and the Annual Forecast Amount for any other given Contract Year
shall not exceed [**] liters. The initial Annual Forecast Amount shall include an
initial delivery date for Finished Product which is not earlier than [**] days from
Emergent’s submission of the initial Rolling Forecast to Talecris. Following
Emergent’s submission of the initial Rolling Forecast, Emergent shall submit to
Talecris on a monthly basis on or before the first Business Day of each month, an
updated Rolling Forecast, provided that (i) the monthly forecast amount shall not
exceed [**] Lots for any given month without Talecris’ prior written approval, and (ii)
the Annual Forecast Amount shall be updated on an annual basis only.
	 
	 	(d)	 	Firm Commitments for Commercial Product. The Rolling Forecast shall be
binding on Emergent for the first [**] months (i.e., months [**]) (each, a “Firm
Commitment”), each of which Firm Commitment shall be the subject of an Order delivered
in accordance with Section 4.02(e).
	 
	 	(e)	 	Orders for Commercial Product. Emergent shall, together with its
monthly Rolling Forecast, deliver to Talecris an Order for each new Firm Commitment
that was only a forecasted amount in the previous month’s Rolling Forecast. Each Order
shall specify the Commercial Product ordered, the quantities of the Commercial Product
ordered, the requested manner and address of delivery, and the requested delivery date,
which shall be no earlier than [**] days from the date of the Order (unless otherwise
agreed to by Talecris), all of which shall be subject

 

 

	 	 	 	to Article 6. Emergent may submit its initial Order for Commercial Product at any
time on or after the commencement of the Commercial Term.

	 	(f)	 	Amending Forecasts for Commercial Product. Any Rolling Forecast that
is not a Firm Commitment is to be considered an estimated forecast to be used for
planning purposes, shall not be construed as a Firm Commitment by Emergent to Talecris,
and may be increased or reduced by Emergent from time to time. Notwithstanding
anything in the foregoing to the contrary, in the event of a Supply Failure as set
forth in Section 4.04(a) below, the Rolling Forecast for each month during which the
Supply Failure persists shall not be considered a Firm Commitment until such time that
Talecris is capable of resuming the Processing of Finished Products under this
Agreement.
	 
	 	(g)	 	Fulfillment of Orders for Commercial Product. Talecris shall
diligently fulfill Emergent’s Orders in accordance with their terms and the terms of
this Agreement, provided that Talecris shall not be obligated to fulfill any Orders
during any Contract Year to the extent that the quantity of Commercial Product covered
by such Orders exceeds in the aggregate [**] percent ([**]%) of the Annual Forecast
Amount for such Contract Year. Talecris shall promptly Notify Emergent if it becomes
aware or believes that it will not be able to fulfill a particular Order that was
included in a Firm Commitment on time, in full or at all, which Notice shall include an
explanation in reasonable detail of the reason for Talecris’ failure to comply with a
particular Order and its proposed course of action for remedying such failure.

	4.03	 	Bona Fide Forecasts. Emergent shall make its Rolling Forecasts under Section 4.02(c)
acting reasonably, in good faith, based on its reasonable expectations for Sales of the
Finished Product (having due regard to any sales over the previous twelve (12) months).
Emergent shall use Commercially Reasonable Efforts to give accurate Rolling Forecasts.
	 
	4.04	 	Alternative Supplier. Emergent shall be required to obtain all of its Finished
Product requirements from Talecris, provided, however, that:

	 	(a)	 	Supply Failure. In the event of a Supply Failure, Emergent shall have
the right to purchase from one or more alternative suppliers its Finished Product
requirements, to the extent necessary to replace Finished Product not provided by
Talecris due to the Supply Failure, until Talecris reasonably demonstrates that
Talecris is able to resume Processing of Finished Product, provided that Emergent shall
[**] Finished Product [**] of the Supply
Failure. In any case, Emergent shall [**] to the Supply Failure. Emergent shall purchase all other
Finished Product requirements from Talecris as soon as Emergent has fulfilled all
obligations or commitments, if any, undertaken by Emergent in connection with
Emergent’s arrangement(s) with the alternative supplier(s). 

 

 

	 	(b)	 	Redundant Supply. Emergent shall have the right to purchase from one
or more alternative suppliers such portion of its Finished Product requirements as
Emergent may reasonably establish, if, and for so long as, any Regulatory Authority,
governmental agency or Applicable Law (relevant to the Major Markets) requires Emergent
to obtain and/or maintain a redundant supply of Finished Product from one or more
alternative suppliers. In such event, to the extent not otherwise prohibited by any
Regulatory Authority, governmental agency or Applicable Law (in the Major Markets),
Emergent shall give priority to selling Finished Product provided by Talecris and
Emergent shall not sell products supplied by a Third Party until the inventory of
Finished Product Processed by Talecris has been exhausted. Emergent shall notify the
appropriate Regulatory Authority or governmental agency in the United States that
Talecris shall act as Emergent’s sole commercial supplier with respect to Finished
Product pursuant to the terms of this Agreement. Emergent shall promptly Notify
Talecris in the event that any Regulatory Authority, governmental agency or Applicable
Law (relevant to the Major Markets) requires Emergent to obtain and/or maintain a
redundant supply of Finished Product from one or more alternative suppliers. Emergent
shall not advocate to any Regulatory Authority that a redundant supply from alternate
suppliers should be required with respect to the Finished Product.

ARTICLE 5 — PROCESS CHANGES; QUALITY ASSURANCE; PRODUCT

SPECIFICATIONS; PROCESSING

	5.01	 	Process Changes.

	 	(a)	 	Prior Approval of Emergent Required. Talecris shall have the right to
make any change to the manufacturing process for Gamunex or other Facility Goods, or to
the Facilities, as such change applies to Gamunex or other Facility Goods, provided,
however, that Talecris shall not make any change to the Process or any Facility (other
than routine maintenance, reconditioning and/or replacement of the equipment) that
would reasonably be expected to have a material negative impact on the AIG or the
Finished Product or require submissions to or approvals from any Regulatory Authority
specific to the Finished Product, except by prior written approval of Emergent for such
change, which approval shall not be unreasonably conditioned, withheld or delayed, and,
in any event, which costs shall be borne by Talecris.
	 
	 	(b)	 	Process Changes Based on cGMP. Talecris shall make such changes to the
Process or any Facility as may be required pursuant to cGMP, provided that (i) changes
to the Process or any Facility which affect the Finished Product, but do not affect
Gamunex or another Facility Good, shall be at Emergent’s cost, and (ii) the cost of any
changes to the Process or any Facility which affect both the Finished Product and
Gamunex or another Facility Good shall be shared between the Parties, taking into
consideration various factors, including without limitation, improvements in Yields for
Finished Product, historical volumes, and other measures mutually agreed upon by the
Parties. If the Parties are not able to reach

 

 

	 	 	 	consensus on the allocation of such costs, such allocation shall be determined in
accordance with the dispute resolution mechanism set forth in Article 14.

	 	(c)	 	Changes Made at the Request of Emergent. From time to time, Emergent
may request that Talecris make certain changes (other than those required pursuant to
Section 5.01(b) above) to the Process; provided, however, that (i) Emergent shall seek
to minimize such changes, (ii) Talecris shall not be required to make any changes which
may have a negative impact on any Facility Good, on Talecris’ ability to manufacture
such Facility Good at the Facilities, or on Talecris’ business, including without
limitation the production of Gamunex, or which require submissions to or approvals from
any Regulatory Authority specific to Gamunex or any other Facility Goods, (iii)
Emergent and Talecris shall enter into good faith negotiations with each other
regarding the assessment of the implications and costs arising from a change to the
Process, and (iv) after the Parties have agreed upon the implications and costs related
to a change to the Process, Talecris may, at its sole discretion, implement such
change. Costs incurred by Talecris in connection with such changes shall be fully
reimbursed by Emergent.

	5.02	 	Quality Assurance.

	 	(a)	 	Testing by Talecris. Talecris shall perform quality testing using
assays proposed by Emergent and acceptable to Talecris (which acceptance shall not be
unreasonably withheld, conditioned or delayed), in order to assure that the Finished
Product complies with the Product Specifications and cGMP, and shall retain samples of
the Finished Product produced and records of the tests made on each such batch of
Finished Product. In addition, no Finished Product shall be delivered until such
Finished Product has been released in accordance with the tests, inspections and
controls required under the Product Specifications and cGMP, and such other tests as
the Parties may mutually agree upon; provided, however, that the foregoing shall not
relieve Talecris of its obligations under Section 4.02(g). Talecris shall maintain
records with respect to the quality testing and shall make such records available to
Emergent during normal business hours, upon prior written request. Without limiting
Talecris’ obligations under Sections 4.01 and 4.02, Talecris shall run, complete and
record such number of qualification batches of the Finished Product as are required by
Regulatory Authorities in the Major Markets pursuant to the BLA submission and ordered
by Emergent pursuant to Sections 4.01(a)-(b), at Emergent’s expense.
	 
	 	(b)	 	Notice of Non-Conforming Products. Talecris shall promptly Notify
Emergent of any Non-Conforming Product of which it becomes aware, specifying the
Finished Product’s release testing and Batch Production Record for the completed Lot.
	 
	 	(c)	 	Testing by Emergent. At Emergent’s election, the Finished Product may
be subjected to testing by Emergent at Emergent’s facilities in order to verify
conformance of the Finished Product with the Product Specifications, Emergent
Specifications and Applicable Law in the Major Markets. Such testing

 

 

	 	 	 	procedures shall be reviewed by Talecris in advance of their implementation.
Emergent shall maintain records with respect to the scope and nature of any such
testing and shall disclose such records to Talecris in a timely fashion.

	 	(d)	 	Notice of Delivery of Non-Conforming Products. Emergent shall Notify
Talecris of any Non-Conforming Product within (i) [**] days of Emergent’s receipt of
such Non-Conforming Product if a defect is discovered by Emergent through the use of
reasonable testing methods and procedures or (ii) in the event of a defect (hidden or
otherwise) which was not discovered through the use of such testing methods and
procedures, the earlier of (A) [**] Business Days following Emergent’s confirmation of
the Non-Conforming status of the Finished Product, and (B) [**] months after delivery
of the Non-Conforming Product. Talecris shall have the right to examine and test any
Finished Product in Emergent’s possession that Emergent claims is Non-Conforming,
provided that such re-testing is conducted in accordance with applicable regulatory
guidelines and other Applicable Law in the Major Markets. The Parties shall cooperate
to determine the point at which the Finished Product became Non-Conforming. In the
event that the Parties cannot agree as to whether any Finished Product is
Non-Conforming, the Parties shall engage a mutually selected independent laboratory to
make such determination in accordance with applicable regulatory guidelines and other
Applicable Law in the Major Markets. If the dispute between the Parties relates to
Talecris’s ability to manufacture and deliver Finished Product that is not
Non-Conforming, which is not attributable to any negligence or willful misconduct of
Emergent, the Parties shall resolve their dispute in accordance with the procedures in
Article 14. This Section shall not relieve Talecris of its obligations to deliver
Finished Products in accordance with Sections 4.02(g) and 6.01.
	 
	 	(e)	 	Responsibilities of the Quality Units. A summary of the
responsibilities of the quality units of each Party related to the Process shall be set
forth on Exhibit E, which responsibilities shall be further described in
Exhibit F. Such responsibilities shall include, without limitation, (i) the
specific content of the Certificate of Analysis, (ii) the specific content of the
Certificate of Conformance, (iii) the nature of the Batch Production Record and/or
Master Batch Record review process, including notification of deviations associated
with the Process, and (iv) a table of key contacts associated with the manufacturing,
regulatory, quality control and quality assurance functions; (v) establishing the
process by which it can be determined whether a particular Lot of Finished Product is
Non-Conforming.
	 
	 	(f)	 	Quality Assurance Audits by Emergent. During the Term, Emergent shall
have the right, at Emergent’s sole cost and expense, during normal business hours and
upon reasonable Notice, to (i) have an Emergent employee present at the Facility(ies)
during Processing and (ii) inspect the Facility(ies) in order to ensure that the
Processing complies with the Product Specifications and cGMP. Such inspections shall
not interfere with Talecris’s operations and shall not exceed one (1) occurrence in any
year; provided, however, that if any such inspection reveals

 

 

	 	 	 	any noncompliance with the Product Specifications or cGMP, Emergent shall have the
right to conduct a reasonable number of follow-on inspections as necessary in order
to confirm that compliance with such Product Specifications and cGMP has been
re-established.

	 	(g)	 	Recalls and Voluntary Withdrawals. If either Party becomes aware of
information about [**] indicating that they may be
Non-Conforming or that there is potential adulteration, misbranding and/or any
potential issues regarding safety or effectiveness, it shall promptly serve Notice to
that effect on the other Party. The Party initiating an investigation and assessment
of such circumstances shall promptly Notify the other Party of its findings and any
proposed course of action. The Parties shall meet to discuss such circumstances and to
consider appropriate courses of action; provided, however, that if Emergent determines
that a recall or withdrawal of the [**] is necessary or advisable, Emergent
shall have final decision-making authority concerning the course of action to be taken
with respect to the affected [**]. Emergent shall bear all costs
associated with such a recall or withdrawal of the [**], unless such recall
or withdrawal is caused by Talecris’ gross negligence or willful misconduct.

	5.03	 	Labeling and Packaging. Talecris shall be responsible for labeling and packaging the
Finished Product for shipment to Emergent or to its designee(s), in accordance with Emergent’s
directions, provided that Emergent shall be responsible for developing the design and content
for the final label and package inserts. Upon Emergent’s request, Talecris shall assist
Emergent in developing the design and content for such final label and package inserts at
Emergent’s cost and Talecris’ standard consulting rates set forth in Exhibit D, and
shall provide regulatory support pursuant to Section 8.09.
	 
	5.04	 	Emergent Specifications; Fill/Finish Specifications. Emergent shall have the right,
from time to time, at its cost, to amend the (a) Emergent Specifications, but only to the
extent such revisions do not affect the Product Specifications, and (b) the Fill/Finish
Specifications, but only to the extent that such revisions are agreed to in writing by
Talecris, provided, that Emergent shall use Commercially Reasonable Efforts to minimize the
frequency of such changes and shall provide Talecris with reasonable advance Notice of any
changes to such portions of the Fill/Finish Specifications. Without limiting the foregoing,
any modifications to the Fill/Finish Specifications required by any Regulatory Authority with
jurisdiction to require such modifications shall be made in accordance therewith. Emergent
shall reimburse Talecris for any additional charges incurred by Talecris as a result of
changes made by Emergent to the Emergent Specifications or the Fill/Finish Specifications.

ARTICLE 6 — DELIVERY

	6.01	 	Delivery. Subject to the provisions of Sections 3.01 and 3.02, Talecris shall use
Commercially Reasonable Efforts to deliver Finished Product in accordance with the delivery
dates specified in the Orders. All shipments shall be made by Talecris (FCA) in accordance
with INCOTERMS 2000 at a Talecris Facility (NY or NC as Talecris may

 

 

	 	 	designate during the Commercial Term from time to time). The delivery of any Finished
Product to Emergent hereunder shall be deemed to occur when such Finished Product is
delivered into the custody of Emergent’s carrier at such designated location. Talecris
shall bear all expense and risk of shipping the AIG, Finished Product, AIG Source Plasma
and/or other materials between its Facilities.

	6.02	 	Certificates of Analysis. Each Finished Product batch delivered to Emergent shall be
accompanied by an appropriate Certificate of Analysis and Certificate of Conformance.
Talecris shall, for customs purposes, upon delivery of Finished Product, provide Emergent with
a valid declaration of origin, in a form reasonably acceptable to Emergent, in respect of all
Finished Products supplied to Emergent under this Agreement, together with such other
supporting documents relating to the origin of such Finished Product as Emergent may
reasonably require.

ARTICLE 7 — FEES; ROYALTY; PAYMENT TERMS

	7.01	 	Deposit. Within thirty (30) days following the Effective Date, Emergent shall pay
Talecris a deposit of [**] Dollars (US$[**]), which shall be fully creditable against the cost
of Lot(s) of Finished Product manufactured by Talecris hereunder and any other amounts payable
by Emergent to Talecris hereunder, including without limitation, the amount payable by
Emergent under Section 7.02 for Start-Up Preparations (as defined below).
	 
	7.02	 	Fees Associated With Certain Pre-Commercial Activities.

	 	(a)	 	Start-Up Preparations. Within thirty (30) days following the Effective
Date, Emergent shall pay Talecris a one-time fee of [**] Dollars (US$[**]) for
Talecris’ performance of reasonable start-up preparations related to the Processing of
Finished Product hereunder, including without limitation preparation of SOP’s, Master
Batch Production Records, assay transfers, equipment validation, and product-specific
cleaning validation (“Start-Up Preparations”). Talecris shall provide Emergent with
documentation of such Start-Up Preparations in form and substance reasonably
satisfactory to Emergent within thirty (30) days following the Effective Date (or such
other time as may be mutually agreed by the Parties) and upon completion thereof. If,
within one-hundred eighty (180) days of the Effective Date, Talecris has failed to
complete the preparation of SOP’s, Batch Production Records and assay transfers and/or
to use Commercially Reasonable Efforts to conduct equipment validation and
product-specific cleaning validation, and such failure can not be attributed in any way
to the acts or omissions of Emergent, and Talecris has not provided to Emergent a
reasonable plan of action for completing such Start-Up Preparations in a reasonable
time period, Emergent shall have the right to terminate this Agreement pursuant to
Section 10.02(i).
	 
	 	(b)	 	Stability Testing. Emergent shall pay Talecris a one-time fee of [**]
Dollars (US$[**]) following Talecris’ performance of the stability testing and related
activities set forth in Section 9.07 hereof.

 

 

	 	(c)	 	Container Closure Study. [**], Talecris shall conduct a container
closure study, as further described on Exhibit K attached hereto.
	 
	 	(d)	 	Process Validation Study. Emergent shall pay Talecris a one-time fee
not to exceed [**] Dollars (US$[**]) for Talecris’ conduct of the process validation
study, as further described on Exhibit K attached hereto.

	7.03	 	Processing Fee.

	 	(a)	 	Processing Fee. Subject to any price adjustments set forth in this
Article 7 and the method of payment set forth in Section 7.07, the Parties agree that
the price of the Finished Product to be charged to Emergent (the “Processing Fee”)
shall be at a rate equal to [**] Dollars ($[**]) per liter. Such Processing Fee shall
include final fill and finish, but shall not include the cost of labels or packaging.
	 
	 	(b)	 	Annual Price Adjustments. During the Commercial Term, upon
commencement of each Contract Year following the first Contract Year, the Processing
Fee and any relevant hourly billable rates of Talecris personnel shall be adjusted
prospectively by a percentage equal to the percentage increase in the US CPI reported
from the commencement of the prior Contract Year, beginning with the calendar quarter
following the publication of the US CPI. For clarity, such adjustment shall take place
only once per Contract Year on a calendar-year basis.

	7.04	 	Royalty.

	 	(a)	 	Commercialization License. Talecris hereby grants to Emergent, under
the Talecris Patent Rights, the rights, which shall be exclusive within the Field, to
commercialize Finished Product, including to use, have used, offer for sale, sell, have
sold, import, and have imported the Finished Product in the Territory .
	 
	 	(b)	 	Royalty Rate. In addition to the Processing Fee set forth in Section
7.03(a), Emergent shall pay Talecris a royalty equal to [**] percent ([**]%) of Net
Sales on a country-by-country basis for Commercial Product manufactured by Talecris
hereunder.
	 
	 	(c)	 	Royalty Term. The royalty payable under Section 7.04(b) shall be paid
on a country-by-country basis on Finished Product Processed by Talecris hereunder (the
“Royalty Term”).
	 
	 	(d)	 	Obligation to Pay. The obligation to pay royalties hereunder is
imposed only once with respect to the same unit of Finished Product.
	 
	 	(e)	 	Royalty Report. Emergent shall deliver to Talecris, within sixty (60)
days after the end of each calendar quarter during the Royalty Term reasonably detailed
written accountings of Net Sales of Finished Product that are subject to royalty
payments due to Talecris for such calendar quarter. When Emergent delivers such
accountings to Talecris, Emergent shall also deliver any royalty payments due under
this Section 7.04 to Talecris for the calendar quarter.

 

 

	7.05	 	Minimum Commitment Fee.

	 	(a)	 	Minimum Commitment Fee. If, during the Commercial Term or any
Extension Period, Emergent fails to submit Orders (other than as a result of any Supply
Failure) for the greater of (i) the total quantity of the [**] or (ii) the total quantity of [**],
Emergent shall be responsible for an amount which is equal to the
difference between the [**] and [**], as applicable (“Minimum Commitment
Fee”). Emergent shall make a payment in cash of the Minimum Commitment Fee within
[**] days of the end of the Contract Year or month, as applicable, during which
the failure occurs.
	 
	 	(b)	 	Exclusive Remedy. Emergent’s payment of fees or submission of Orders,
as applicable, as set forth under this Section 7.05, shall be Talecris’ exclusive
remedy and Emergent’s sole liability, solely with respect to any failure to submit
Orders as set forth herein.

	7.06	 	Method of Invoicing for Orders. All Orders under this Agreement shall be invoiced at
the time of Finished Product release by Talecris.
	 
	7.07	 	Remittance of Payments. Payments due by Emergent under this Article 7 shall be
payable by Emergent no later than thirty (30) days after the invoice date; provided, however,
that the Finished Product associated with such payment was actually delivered in compliance
with Section 6.01. Emergent shall make payment by wire transfer of Dollars to a bank account
designated by Talecris or by such other payment method as the Parties may agree upon from time
to time.
	 
	7.08	 	Foreign Currency. Payments made under this Agreement shall be payable in United
States Dollars. With respect to foreign exchange rate conversion, Net Sales calculated under
this Agreement shall be computed for each quarter with Foreign Currency Sales converted into
United States Dollars using the average exchange rate for such period, which average exchange
rate shall be the actual rate as utilized by Emergent for its standard financial reporting,
provided that such rate shall be consistent with other generally available, publicly reported
exchange rates.
	 
	7.09	 	Talecris’ Right to Audit. Emergent shall maintain and keep (and shall cause its
Affiliates and Sublicensees to maintain and keep) for three (3) years after payment is made or
should have been made by Emergent under this Agreement complete and accurate books and records
in sufficient detail to calculate all sums falling due or which should fall due for payment by
Emergent under this Agreement. No more than once during each calendar year during the Term,
Emergent shall permit Talecris’ independent auditors, to

 

 

	 	 	whom Emergent has no reasonable objection and with reasonable Notice at any time during
Emergent’s normal business hours, to inspect, audit and copy relevant accounts and records
of Emergent, its Affiliates and Sublicensees, for the sole purpose of verifying the accuracy
of the calculation of payments to Talecris based on Net Sales and the reports which
accompanied them. Talecris’ independent auditors shall not disclose to Talecris any
information other than information relating solely to the accuracy of the accounting and
payments made by Emergent. If such audit determines that payments are due to Talecris,
Emergent shall pay to Talecris any such additional amounts within thirty (30) days of the
date on which such auditor’s written report is delivered to Emergent, unless such audit
report is disputed, in which case the dispute shall be resolved in accordance with Article
14. If the auditor determines that Emergent’s payments are in excess of those required
under this Agreement, Talecris shall credit the amount of such overpayment towards any
amounts payable by Emergent to Talecris under this Agreement within ninety (90) days
following the date of the auditor’s determination of such overpayment, and shall promptly
remit to Emergent any portion of such overpayment which has not been credited within such
ninety (90) day period, unless such audit report is disputed, in which case the dispute
shall be resolved in accordance with Article 14. Any such inspection of records shall be at
Talecris’s expense unless such audit discloses a deficiency in the payments made by Emergent
of more than five percent (5%), in which case Emergent shall bear the cost of such audit.

	7.10	 	Deductions from Payments. Any income or other taxes which Emergent is required by
Applicable Law to pay or withhold on behalf of Talecris with respect to payments and any other
monies payable to Talecris under this Agreement shall be deducted from the amount of such
payments and other monies due and paid to the relevant competent taxing authority. Emergent
shall furnish Talecris with proof of such payments. Any such tax required to be paid or
withheld shall be an expense of and borne solely by Talecris. Emergent shall promptly provide
Talecris with a certificate or other documentary evidence and provide reasonable assistance to
enable Talecris to support a claim for a refund or a foreign tax credit with respect to any
such tax so withheld or deducted by Emergent. Emergent and Talecris will reasonably cooperate
in completing and filing documents required under the provisions of any applicable tax treaty
or under any other Applicable Law, in order to enable Emergent to make such payments to
Talecris without any deduction or withholding, if possible.

ARTICLE 8 — IND/BLA; REGULATORY MATTERS

	8.01	 	Preparation of INDs and BLAs.

	 	(a)	 	Drafting. Emergent shall prepare and submit all necessary regulatory
approvals for the AIG and/or Finished Product other than the Talecris BLA sections (as
defined below), including without limitation INDs and the BLAs in the United States for
the production of Initial AIG Source Plasma and for the Processing of Finished Product
(including, without limitation, the filling and finishing of Finished Product, but
excluding those activities set forth on Exhibit I attached hereto (“Talecris
Gamunex Activities”), including any amendments or supplements thereto (“Emergent
BLAs”). Emergent shall reasonably determine,

 

 

	 	 	 	upon consultation with Talecris and taking into account in good faith Talecris’
concerns and proposed timetable for submission of the Talecris BLA sections, the
timing of the submission of the Emergent BLAs to the Regulatory Authorities.
Talecris shall, at Talecris’ expense, diligently and timely prepare and submit in
compliance with Applicable Law in the Major Markets the portions of the BLA that
cover the Talecris Gamunex Activities, including any amendments or supplements
thereto (“Talecris BLA sections”), in the United States and in any other country or
group of countries where such separate submission by Talecris is required, in
accordance with the submission date(s) established by Emergent, which shall take
into account in good faith Talecris’s concerns and proposed timetable for submission
of the Talecris BLA sections.

	 	(b)	 	Assistance by Talecris. Talecris hereby agrees to provide (i) to
Emergent all information and regulatory support which is reasonably necessary in the
preparation of comprehensive and complete INDs for Finished Product and the Emergent
BLAs, and any amendments and supplements thereto, including, without limitation, the
Talecris BLA sections (including without limitation the Chemistry Manufacturing and
Controls (CMC) section), and (ii) access to the Facilities and pertinent information to
Emergent and to FDA inspectors conducting the pre-approval inspection. Talecris shall
provide such regulatory support pursuant to the provisions of Section 8.09.
	 
	 	(c)	 	Changes. Subject to Section 5.01 and Section 8.06, each Party shall be
responsible for timely notifying the applicable Regulatory Authority regarding proposed
changes to the portion of the Process or Product Specifications or Emergent
Specifications, as the case may be, covered by such Party’s relevant sections of the
Emergent BLAs in accordance with Applicable Law in the Major Markets.

	8.02	 	Ownership. The Parties agree that all INDs arising under this Agreement related to
AIG and/or Finished Product will be owned solely by Emergent, that Emergent BLAs arising under
this Agreement, except for the Talecris BLA sections, will be owned solely by Emergent and
held in the name of Emergent, in compliance with Applicable Law in the Major Markets.
	 
	8.03	 	Right of Cross-Reference. Emergent shall have the right to cross-reference all
Talecris regulatory documents related to the Finished Product and/or the Process which are on
file with applicable Regulatory Authorities as necessary in order to obtain all applicable
regulatory approvals for Finished Product. During the term of the Agreement (excluding any
suspensions of performance thereunder), Talecris shall have the right to cross-reference all
Emergent regulatory documents related to the Finished Product and/or the Process which are on
file with applicable Regulatory Authorities, solely as necessary for Talecris to Process
Finished Product for Emergent under this Agreement or to exercise the rights granted to
Talecris with respect to By-Products pursuant to Section 3.04 above. Talecris shall provide
Emergent with regulatory support as reasonably necessary for each Party to obtain and maintain
all necessary regulatory approvals for Finished Product

 

 

	 	 	hereunder. Talecris shall provide such regulatory support pursuant to the provisions of
Section 8.09.

	8.04	 	Subsequent Filings or Applications. Talecris hereby agrees to provide to Emergent,
regulatory support, data and other information which is reasonably necessary for the
preparation of IND annual reports and/or any subsequent filings or applications Emergent may
submit to the FDA pursuant to the provisions of Section 8.09.
	 
	8.05	 	Record and Files. Talecris shall maintain those documents required by applicable
cGMP regulations. Emergent shall have the right to audit such Talecris documents and records
related to the Processing of Finished Product upon reasonable advance Notice to Talecris and
at reasonable intervals during the Term (but not more frequently than once every twelve (12)
month period) to verify Talecris’ compliance with such requirements.
	 
	8.06	 	Communications with Regulatory Authorities. Talecris shall not, without the consent
of Emergent or unless so required by Applicable Law in the Major Markets, correspond or
communicate with any Regulatory Authority specifically regarding the Finished Product.
Furthermore, Talecris shall, as soon as practicable after any contact with or receipt of any
communication from any Regulatory Authority relating to the Finished Product, forward a copy
or description of the same to Emergent and respond to all inquiries by Emergent relating
thereto. If Talecris is advised by its counsel that it must communicate with any Regulatory
Authority specifically regarding the Finished Product, then Talecris shall so advise Emergent
as soon as practicable and, unless prohibited by Applicable Law in the Major Markets, provide
Emergent in advance with a copy of any proposed written communication with any Regulatory
Authority and comply with any and all reasonable direction of Emergent concerning any meeting
or written or oral communication with any Regulatory Authority. To the extent permitted by
the Regulatory Authority, Emergent shall have the right to participate in any planned oral
communications or meetings between Talecris and any Regulatory Authority relating to Finished
Product, including without limitation periodic reporting sessions. For purposes of
clarification, the obligations imposed on Talecris pursuant to this Section 8.06 shall not
apply with respect to communications with Regulatory Authorities that are focused primarily on
Gamunex and not on the Finished Product.
	 
	8.07	 	Governmental Inspections. Talecris shall immediately Notify Emergent in the event
that any Regulatory Authority carries out or gives notice of its intention to carry out any
inspection or investigation in connection with the Finished Product. To the extent permitted
by the Regulatory Authority, Emergent shall have the right to be present at and observe any
such inspection.
	 
	8.08	 	Post-Approval Obligations. Unless otherwise set forth in this Agreement, Emergent
shall be responsible, at its own cost, for post-approval regulatory obligations associated
with the Finished Product, including without limitation post-marketing clinical trials,
additional product stability studies, drug safety monitoring, complaint handling, recalls,
error and accident reporting, and adverse experience reporting, as each may be further
described in Article 9. Emergent may procure regulatory support services from Talecris
pursuant to the provisions of Section 8.09.

 

 

	8.09	 	Regulatory Support; Investigations; Reports; Data. Talecris shall provide regulatory
support, investigative support and reports or data to Emergent in support of filings to the
Regulatory Authorities of the Major Markets only up to a maximum of [**] hours at no cost to
Emergent, and, subject to Talecris’ agreement, at Talecris’ standard consulting rates set
forth on Exhibit D for Talecris’ personnel time in excess of the cap set forth herein.
For other markets, Talecris shall use Commercially Reasonable Efforts to support Emergent at
the consulting rates set forth on Exhibit D. Talecris shall use diligent efforts to
provide the regulatory, advisory and related services under this Agreement in a professional
manner; provided, however, that in no event does Talecris guarantee the outcome of such
services.

ARTICLE 9 — REPORTING OF EVENTS

	9.01	 	Exchange of Drug Safety Information. Each Party shall, and shall require that its
Affiliates, (a) adhere to all Applicable Laws in the Major Markets which relate to the
reporting and investigation of Adverse Events and biological product deviations as defined in
21 C.F.R. Part 600.14, and (b) keep the other Party informed of such experiences related to
the Finished Product.
	 
	9.02	 	Adverse Events and Biological Product Deviations.

	 	(a)	 	Regulatory Reporting. Emergent shall have sole and exclusive
responsibility for worldwide regulatory reporting of all Adverse Events and biological
product deviations with respect to the Finished Product. In order that Emergent may be
fully informed, Talecris shall, and shall require that its Affiliates and Sublicensees,
provide Notice to Emergent of all Adverse Events and biological product deviations with
respect to the Finished Product anywhere in the world in accordance with the timelines
specified herein. Notwithstanding the foregoing, all Adverse Events and biological
product deviations with respect to the Finished Product shall be reported by Talecris
to Emergent promptly enough to allow Emergent sufficient time to evaluate, process and
comply with worldwide regulatory reporting. Talecris shall have sole and exclusive
responsibility for worldwide regulatory reporting of all Adverse Events and biological
product deviations with respect to Gamunex, activities required to meet the Gamunex
Specifications, or By-Products. In order that Talecris may be fully informed, Emergent
shall, and shall require that its Affiliates, provide Notice to Talecris of all Adverse
Events and biological product deviations with respect to the Finished Product anywhere
in the world that may affect Gamunex, activities required to meet the Gamunex
Specifications or By-Products, in accordance with the timelines specified herein.
Notwithstanding the foregoing, to the extent practicable, all such Adverse Events and
biological product deviations with respect to the Finished Product shall be reported by
Emergent to Talecris promptly enough to allow Talecris sufficient time to evaluate,
process and comply with worldwide regulatory reporting.
	 
	 	(b)	 	Complaints. [**] all complaints, as defined in 21 C.F.R. Part 211.198 or any
analogous

 

 

	 	 	 	regulations or requirements in jurisdictions outside the United States, regarding
the Finished Product. [**] shall Notify [**] within [**] hours of becoming
aware of a complaint, including [**]. Talecris shall timely
cooperate in [**], including providing information applicable to each, and shall timely
initiate and complete corrective and preventive actions related to such
investigations and identified product and quality system nonconformities that are
the responsibility of Talecris under this Agreement. Talecris shall make [**] accessible to Emergent for purposes of FDA
inspection in accordance with FDA regulations or pursuant to applicable regulations
and requirements in jurisdictions outside the United States. [**] shall Notify
[**] within [**] hours of becoming aware of a complaint pertaining to the
[**] which may affect Gamunex or the Process, and shall timely share
information pertaining to the investigation of such complaint with Talecris.

	 	(c)	 	Reports. Talecris shall provide to Emergent, within [**] hours of
becoming aware thereof, information from any source that suggests an Adverse Event
related to the [**] occurred. Emergent shall provide to Talecris, within
[**] hours of becoming aware thereof, information from any source that suggests an
Adverse Event related to the [**] occurred. This information shall include
any adverse drug experience or reaction reports or any other reports or information,
from whatever source derived, indicating that the [**] has any toxicity,
sensitivity reactions, or is otherwise alleged to cause illness or injury of any kind
due to a possible product quality problem, or is adulterated or misbranded.
	 
	 	(d)	 	Investigations and Inquiries. With respect to information received
regarding [**] complaints, Adverse Events and biological product
deviations, Talecris shall thereafter reasonably cooperate with Emergent and the
Regulatory Authority regarding an investigation or inquiry directed at the [**]
that may be initiated by a Regulatory Authority or otherwise required in
response to a [**] with respect thereto (which
investigation or inquiry [**] shall have the right to direct and control) and shall
further provide Emergent with all data or other information related solely to the
[**] and excluding data or other information related to Gamunex that
Emergent may reasonably require in connection with any reports or correspondence that
Emergent provides to the Regulatory Authority, the [**]
relative to any such adverse drug reaction [**]
complaint.

	9.03	 	Exchange of Drug Safety Requests. The Parties shall immediately provide each other
with copies of all drug safety requests from all governmental agencies and Regulatory
Authorities directed solely toward the Finished Product. Proposed answers materially
affecting the Finished Product will be exchanged between the Parties before submission and the
Parties shall cooperate with respect to such answers; provided, however, that

 

 

	 	 	Emergent shall have ultimate decision-making authority with respect to answers relating
solely to the Finished Product, unless Applicable Law in the Major Markets requires
otherwise. The Parties shall exchange decisions from applicable health authorities
immediately.

	9.04	 	Regulatory Actions. Each Party shall advise the other Party of any regulatory action
of which it is aware, which would affect the Finished Product in any country in the Major
Markets.
	 
	9.05	 	Events Affecting Integrity or Reputation. During the Term, the Parties shall Notify
each other immediately of any circumstances of which they are aware which arise whereby the
integrity and reputation of the Finished Product or of the Parties are threatened by the
unlawful activity of any Third Party in relation to the Finished Product.
	 
	9.06	 	Retention of Product Samples. Talecris shall, or shall cause one of its Affiliates
to, retain all records and samples with respect to the Finished Product supplied by Talecris
in accordance with Applicable Law in the Major Markets.
	 
	9.07	 	Stability. Talecris will perform stability testing, data interpretation, reporting
and updating of stability information to regulatory documents for the Finished Product.
Talecris shall perform such stability testing and related activities in accordance with the
stability protocols, Talecris procedures, timing and other terms as set forth on Exhibit
H, from the date of commencement of Processing of Finished Product from each Lot.
	 
	9.08	 	Annual Product Reviews. On a calendar-year basis, Talecris will prepare summary data
for Finished Product Processed within the prior calendar year. Such data will be prepared and
sent to Emergent within one calendar month (unless otherwise agreed by Talecris and Emergent)
of the end of the applicable calendar year during which the Finished Product was Processed
hereunder. This data will include [**]. Such
data shall be prepared pursuant to the provisions of Section 8.09.
	 
	9.09	 	Quality Assurance Investigations. Upon Notice to Talecris that Emergent has received
an Adverse Event, product complaint or inquiry regarding Finished Product supplied by Talecris
to Emergent hereunder, Talecris shall (or shall cause one of its Affiliates to) within a
reasonable period, conduct a quality assurance investigation to determine if any process or
testing deviations or events may have contributed to such Adverse Event, complaint or inquiry.
Quality assurance investigations may include a review of Batch Production Records and the
evaluation of returned or retained samples of Finished Product. Talecris shall, or shall
cause one of its Affiliates to, supply Emergent with the outcome of the investigation within
thirty (30) days of Emergent’s notice. In cases where a more comprehensive investigation
might be required, the Parties will jointly develop an investigational plan. Talecris shall
conduct such quality assurance investigations pursuant to the provisions of Section 8.09.

 

 

ARTICLE 10 — TERM AND TERMINATION

	10.01	 	Pre-Commercial Term; Commercial Term; Term.

	 	(a)	 	Pre-Commercial Term. “Pre-Commercial Term” shall mean the period
commencing on the Effective Date and ending on the earlier of (i) January 1, 2009, or
January 1, 2010 if Emergent gives Notice to Talecris by at least December 31, 2008 that
it desires to extend the Pre-Commercial Term until January 1, 2010 and (A) the
aggregate amount paid by Emergent to Talecris under this Agreement prior to December
31, 2008 plus the aggregate amount committed to be paid by Emergent during the first
six (6) months of 2009 for (1) Pre-Commercial Product based on the forecasts and orders
for such period and (2) other services to be provided hereunder during such period,
equals or exceeds [**] Dollars (US$[**]), or (B) Emergent pays Talecris on or before
December 31, 2008 a non-refundable deposit of [**] Dollars (US$[**]) less all amounts
already paid or committed to be paid as described in the immediately preceding clause
(i) (the “Extension Deposit”); and (ii) such date that is twelve (12) months following
the date on which Emergent provides Notice to Talecris of its desire to commence the
Commercial Term. The Extension Deposit, if any, shall be fully creditable against any
amounts payable thereafter by Emergent to Talecris hereunder.
	 
	 	(b)	 	Commercial Term. “Commercial Term” shall mean a five (5) year period
commencing on the earlier of (i) either January 1, 2009 or, if the Pre-Commercial Term
was extended pursuant to the terms of Section 10.01(a) above, January 1, 2010, or (ii)
such earlier date that is twelve (12) months following the date on which Emergent
provides Notice to Talecris of its desire to commence the Commercial Term.
	 
	 	(c)	 	Term. Unless earlier terminated as set forth below, this Agreement
shall be in effect from the Effective Date until the end of the Commercial Term (the
“Initial Term”), which Commercial Term may be extended by Emergent for an additional
five (5) year period (“Extension Period”) upon Notice to Talecris at least twelve (12)
months prior the expiration of such Initial Term; provided, however, that Emergent
shall have no right to extend the Commercial Term if Talecris has provided to Emergent
a Notice of termination pursuant to Section 10.02(b) (Elective Termination by
Talecris). The “Term” shall consist of the Initial Term and any Extension Period.

	10.02	 	Termination. This Agreement may be terminated in accordance with the following
sections.

	 	(a)	 	Elective Termination by Emergent. Emergent may terminate this
Agreement by giving at least two (2) years’ advance Notice (“Emergent Elective
Termination Notice”) to Talecris, which Emergent Elective Termination Notice may not be
given prior to the completion of the third (3rd) Contract Year during the
Commercial Term but may be given at any time thereafter (including without

 

 

	 	 	 	limitation during any Extension Period). Upon the second (2nd)
anniversary of the Emergent Elective Termination Notice, this Agreement shall
terminate.
	 	(b)	 	Elective Termination by Talecris. Talecris may terminate this
Agreement by giving at least two (2) years’ advance Notice (“Talecris Elective
Termination Notice”) to Emergent, which Talecris Elective Termination Notice may not be
given prior to the completion of the third (3rd) Contract Year during the
Commercial Term but may be given at any time thereafter (including without limitation
during any Extension Period). If, despite good faith efforts, Emergent is unable to
obtain regulatory approval for the manufacture and sale of any alternative Finished
Product during the two (2) year notice period commencing upon the date of the Talecris
Elective Termination Notice (“Termination Notice Period”), Emergent may Notify Talecris
that Emergent desires for Talecris to continue to Process Finished Product for
Emergent. Upon receipt of such Notice, Talecris shall continue to Process Finished
Product for Emergent at a price per liter equal to [**] percent ([**]%) of the
then-current Processing Fee until such time as Emergent obtains regulatory approval for
such alternative Finished Product, provided that (a) Emergent shall continue to use
good faith efforts to obtain such regulatory approval during such period of extension
of the Termination Notice Period (“Termination Extension Period”), and (b) the
Termination Extension Period shall be no longer than an additional twelve (12) months
following the end of the Termination Notice Period. This Agreement shall terminate
upon the later of the end of the Termination Notice Period or any Termination Extension
Period.
	 
	 	(c)	 	Mutual Agreement. This Agreement may be terminated by mutual written
agreement of the Parties.
	 
	 	(d)	 	Force Majeure. In the event a Party (“Affected Party”) continues to
experience a Force Majeure condition for a period of at least twelve (12) consecutive
months after Notice of the Force Majeure was given pursuant to Section 15.11, the other
Party shall be entitled to terminate this Agreement by giving a Notice of termination
to the Affected Party at any time while such Force Majeure persists thereafter.
	 
	 	(e)	 	Supply Failure. Upon the occurrence of a Supply Failure that has not
been corrected within [**] from the triggering of the Supply Failure, Emergent shall
have the right to terminate this Agreement by giving a Notice of termination to
Talecris, such termination to take effect upon delivery of the Notice of termination.
	 
	 	(f)	 	Material Breach by Emergent. In the event Emergent commits a material
breach of this Agreement, Talecris shall be entitled to terminate this Agreement if
such breach is not cured within sixty (60) days of Notice from Talecris, in which case
the termination shall be effective sixty (60) days after receipt of the Notice;
provided, however, that if such breach is incapable of cure within such sixty (60)

 

 

	 	 	 	day period, the termination shall be effective upon delivery of the Notice of
material breach.
	 
	 	(g)	 	Material Breach by Talecris. In the event Talecris commits a material
breach of this Agreement, Emergent shall be entitled to terminate this Agreement if
such breach is not cured within sixty (60) days of Notice from Emergent, in which case
the termination shall be effective sixty (60) days after receipt of the Notice;
provided, however, that if such breach is incapable of cure within such sixty (60) day
period, the termination shall be effective upon delivery of the Notice of material
breach.
	 
	 	(h)	 	Insolvency. Either Party shall be entitled to terminate this
Agreement, by giving Notice to the other Party (“Insolvent Party”), in the event of an
Insolvency Event occurring in relation to the Insolvent Party, such termination to take
effect upon delivery of the Notice of termination to the Insolvent Party.
	 
	 	(i)	 	Pre-Commercial Failure. During the Pre-Commercial Term, Emergent shall
have the right to terminate this Agreement by Notice to Talecris if Talecris has failed
to meet its obligations (i) to perform Start-Up Preparations as set forth in Section
7.02 above; or, (ii) pursuant to Pre-Commercial Target Yield provisions as set forth in
Section 4.01(c). Such Notice of termination shall take effect upon delivery of such
Notice to Talecris.
	 
	 	(j)	 	Termination of AIG Program. Emergent shall have the right to terminate
this Agreement by Notice to Talecris if (i) Emergent’s production of AIG Source Plasma
or development of AIG or Finished Product is discontinued or terminated for any reason
other than for safety concerns, or (ii) Emergent determines in good faith not to file
an IND for Finished Product, or the FDA rejects an IND or BLA for Finished Product.
Such Notice of termination shall take effect upon delivery of such Notice to Talecris.
	 
	 	(k)	 	Safety Concerns. Emergent shall have the right to terminate this
Agreement by Notice to Talecris if Emergent determines in good faith that the
development or commercialization of AIG or Finished Product should be discontinued for
safety reasons and the safety problem cannot be resolved by modification of the Product
Specifications. Such Notice of termination shall be accompanied by a written statement
explaining in reasonable detail such safety concerns, and the basis thereof, and shall
take effect upon delivery of such Notice to Talecris.

	10.03	 	[Section Intentionally Left Blank]
	 
	10.04	 	Talecris’ Rights Upon Termination of AIG Program.

	 	(a)	 	Termination During Pre-Commercial Term. In the event Emergent
terminates this Agreement pursuant to Section 10.02(j) (Termination of AIG Program) or
Section 10.02(k) (Safety Concerns) during the Pre-Commercial Term, within thirty (30)
days following such termination, Emergent shall pay Talecris the aggregate Processing
Fees which would have been payable to Talecris for the

 

 

	 	 	 	total amount of Finished Product covered by all Orders that are submitted to
Talecris prior to such termination had such termination not occurred.
	 	(b)	 	Termination During Commercial Term. In the event Emergent terminates
this Agreement pursuant to Section 10.02(j) (Termination of AIG Program) or Section
10.02(k) (Safety Concerns) during the Commercial Term, within thirty (30) days
following such termination, Emergent shall pay Talecris twice (X2) the aggregate
Processing Fees for the Commercial Volume Commitment in effect for the current Contract
Year.

	10.05	 	Effect of Termination. Except as specifically set forth in this Agreement, all
rights and obligations of the Parties shall terminate upon the expiration or termination of
this Agreement, provided that such expiration or termination is without prejudice to any
accrued rights of the Parties and shall not be construed to release either Party of any
obligation matured prior to the effective date of such termination or expiration.
	 
	10.06	 	Survival. Sections 2.04, 3.03, 3.04, 7.09 (and the remainder of Article 7 to the
extent any amounts are owed but unpaid), 8.02 and 10.04-10.06, and Articles 1, 11, 12, 13, 14,
and 15 shall survive the expiration or termination of this Agreement in accordance with their
terms.

ARTICLE 11 — REPRESENTATIONS AND WARRANTIES

	11.01	 	Warranty by Talecris. Talecris hereby represents and warrants to Emergent the
following:

	 	(a)	 	Compliance with Product Specifications. The Finished Product shall
have been Processed in accordance with the Product Specifications and cGMP, shall
comply with the Product Specifications and cGMP, and shall not be adulterated or
misbranded within the meaning of any applicable food and/or drug law or regulation in
the Major Markets, all at time of delivery.
	 
	 	(b)	 	Rights. Talecris has all rights necessary to undertake the activities
contemplated under this Agreement.
	 
	 	(c)	 	Ownership of Talecris Patent Rights. Talecris holds good title to and
is the legal and beneficial owner of the Talecris Patent Rights, free and clear of all
liens, security interests and other recorded encumbrances of any kind.
	 
	 	(d)	 	Validity and Enforceability; Non-Infringement. To Talecris’ knowledge,
(i) the Talecris Patent Rights are valid and enforceable, (ii) the Processing of
Gamunex to the extent that such Processing is applicable to the Finished Product would
not infringe the patent rights or misappropriate the trade secrets of any Third Party,
and (iii) no Third Party is infringing any Talecris Patent Rights.
	 
	 	(e)	 	Investigations. There are no inquiries, actions, investigations or
other proceedings pending before or, to the best of Talecris’ knowledge, threatened by
any Regulatory Authority or other governmental agency with respect to any

 

 

	 	 	 	Facility or with respect to Gamunex, and Talecris has not received written notice
threatening any such inquiry, action or other proceeding.

	11.02	 	Warranty by Emergent. Emergent hereby represents and warrants to Talecris the
following:

	 	(a)	 	AIG Source Plasma. As of the time of delivery of AIG Source Plasma to
Talecris hereunder, such AIG Source Plasma shall comply with the AIG Source Plasma
Specifications and Applicable Laws (“Conforming AIG Source Plasma”) and shall not be
adulterated or misbranded within the meaning of any applicable food and/or drug law or
regulation. If any Non-Conforming AIG Source Plasma is delivered to Talecris
hereunder, Emergent shall replace or have replaced such Non-Conforming AIG Source
Plasma with Conforming AIG Source Plasma, as reasonably necessary for Talecris to
manufacture Finished Product hereunder. For the avoidance of doubt, if any
Non-Conforming AIG Source Plasma is delivered to Talecris hereunder and Talecris
Processes or has Processed such Non-Conforming AIG Source Plasma in accordance with the
terms of this Agreement prior to Talecris becoming aware of such non-conformity,
Emergent shall pay for the Processing of such Lot(s) of Non-Conforming AIG Source
Plasma. Talecris shall, at Emergent’s option and cost, either destroy or return to
Emergent any unprocessed Non-Conforming AIG Source Plasma.
	 
	 	(b)	 	Rights. Emergent has all rights to undertake the activities
contemplated under this Agreement.
	 
	 	(c)	 	Investigations. There are no inquiries, actions, investigations or
other proceedings pending before or, to the best of Emergent’s knowledge, threatened by
any Regulatory Authority or other governmental agency with respect to Finished Product,
and Emergent has not received written notice threatening any such inquiry, action or
other proceeding.

	11.03	 	Disclaimer of Warranties. The warranties set forth in Sections 11.01 and 11.02 are
exclusive and are in lieu of all other warranties, whether written or oral express, implied or
statutory. EXCEPT WITH RESPECT TO THE FOREGOING WARRANTY, THERE IS NO WARRANTY OF
MERCHANTABILITY, SATISFACTORY QUALITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE
GIVEN BY TALECRIS WITH RESPECT TO THE FINISHED PRODUCT OR BY EMERGENT WITH RESPECT TO THE AIG
SOURCE PLASMA.
	 
	11.04	 	Remedies for Delivery of Non-Conforming Products or Spoiled AIG Source Plasma.

	 	(a)	 	General. In the event that Talecris Processes Non-Conforming Products
it shall refund or credit any Processing Fees associated with such Non-Conforming
Product resulting from the failure to follow the Process, negligence or willful
misconduct in Processing the AIG Source Plasma. For the purpose of this Agreement,
failure to follow the Process shall deemed to be negligence. In addition, Emergent
shall, at Talecris’s option and cost, either return or destroy any

 

 

	 	 	 	Non-Conforming Products. Any Non-Conforming Products returned by Emergent pursuant
to this Section shall be delivered to Talecris at its Facility.
	 	(b)	 	Damages for Spoiled AIG Source Plasma. Talecris shall pay Emergent an
amount equal to (i) [**] Dollars ($[**]) for each liter of Spoiled AIG Source Plasma
resulting from the [**] of Talecris, and (ii) [**] Dollars ($[**]) for each liter of
Spoiled AIG Source Plasma resulting from the [**] of Talecris. “Spoiled AIG Source
Plasma” shall mean Conforming AIG Source Plasma which (i) has been Processed but
results in Non-Conforming Product, (ii) cannot reasonably be Processed in accordance
with Product Specifications and cGMP to produce Finished Product which conforms to the
Product Specifications and cGMP, or (iii) is otherwise lost or destroyed.
	 
	 	(c)	 	Non-Conformance with Emergent Specifications. Notwithstanding anything
in the foregoing to the contrary, if Finished Product does not meet the Emergent
Specifications, upon receipt of Notification by Emergent of such variance or
non-conformance, Talecris shall use Commercially Reasonable Efforts (i) to assist
Emergent in investigating the cause of any such variance or non-conformance and (ii) to
cure such variance or non-conformance, pursuant to the provisions of Section 8.09.
For the avoidance of doubt, in no event shall Talecris be obligated to effect, or
undertake efforts to effect a cure under this Section 11.04(c) that would adversely
affect the Gamunex Specifications or require the implementation of any changes to
Talecris’ production of Gamunex.
	 
	 	(d)	 	Remedies Exclusive. Except for Product Liability claims for Finished
Product governed by Section 12.03(a), the payments provided for under this Section
11.04 shall be Emergent’s exclusive remedy, and Talecris’ sole liability, in connection
with Talecris’ delivery of Non-Conforming Products.

ARTICLE 12 — INDEMNIFICATION

	12.01	 	Indemnification In Favor of Emergent. Subject to Section 12.02, Talecris shall
defend, indemnify and hold harmless each Emergent Indemnitee from and against any and all
Losses for (a) any Claims of Third Parties that arise as a result of a material breach of any
covenant, agreement, warranty or representation made by Talecris or any of its Affiliates
under this Agreement which causes the Finished Product to not be Processed in accordance with
Product Specifications, (b) any Third Party Claims of patent infringement or trade secret
misappropriation involving the Processing of the Finished Product, but only to the extent such
Third Party Claim is specifically directed to the activities required to meet the Gamunex
Specifications, (c) any Claims of Third Parties (including, without limitation, any Product
Liability Claims) that arise as a result of the development, manufacture, marketing,
promotion, sale, disposition, distribution or other use of By-Products, (d) any Product
Liability Claims, or such portion of Product Liability Claims, with respect to Finished
Product as are allocated to Talecris pursuant to Section 12.03(a), and (e) any Claims arising
from the regulatory, advisory and related services provided by Talecris in connection with
this Agreement. Talecris shall not be obligated under this Section 12.01 to the extent it is
shown that the Loss was the direct result of a

 

 

	 	 	material breach of any covenant, warranty or representation made by Emergent under this
Agreement. Except with respect to the indemnification of any Claim covered by clause (b) or
(c) above, the indemnity in this Section 12.01 shall be limited to the greater of the (i)
Processing Fees paid by Emergent during the twelve (12) months prior to the date the Claim
arose, (ii) the Commercial Volume Commitment for the Contract Year during which such Claim
arose, or (iii) the Firm Commitment for the Contract Year during which such Claim arose.
	12.02	 	Indemnification In Favor of Talecris. Emergent shall defend, indemnify and hold
harmless each Talecris Indemnitee from and against any and all Losses for (a) any Claims of
Third Parties that arise as a result of a material breach of any covenant, agreement, warranty
or representation made by Emergent under this Agreement, (b) any Claims of Third Parties of
patent infringement or trade secret misappropriation involving the Processing or Sale of the
Finished Product and which is not specifically directed to the activities required to meet the
Gamunex Specifications, and (c) any Product Liability Claims, or such portion of Product
Liability Claims, with respect to Finished Product as are allocated to Emergent pursuant to
Section 12.03(b). Emergent shall not be obligated under this Section 12.02 to the extent it
is shown that the Loss was the direct result of a material breach of any covenant, warranty or
representation made by Talecris under this Agreement.
	 
	12.03	 	Product Liability Claims. Notwithstanding the foregoing Sections 12.01 and 12.02,
the Parties’ responsibilities with respect to Product Liability Claims for Finished Product
shall be governed by this Section 12.03.

	 	(a)	 	Talecris’ Liability. Talecris shall be solely responsible for all
Product Liability Claims that arise out of Non-Conforming Product where such
nonconformance (i) arose from Talecris’ failure to Process Finished Product in
accordance with Product Specifications or cGMP, and (ii) existed at the time the
Finished Product was delivered by Talecris; provided, however, that Talecris’ liability
for such Product Liability Claims shall be limited to the greater of the (A) Processing
Fees paid by Emergent during the twelve (12) months prior to the date the Claim arose,
(B) the Commercial Volume Commitment for the Contract Year during which such Claim
arose, or (C) the Firm Commitment for the Contract Year during which such Claim arose.
	 
	 	(b)	 	Emergent’s Liability. Emergent shall be solely responsible for all
Product Liability Claims other than those for which responsibility was allocated to
Talecris pursuant to Section 12.03(a).
	 
	 	(c)	 	Responsibility for Settlement and Defense. The Parties shall jointly
defend and settle any Product Liability Claim with respect to the Finished Product.
Notwithstanding the foregoing, at such time that Talecris reasonably determines in good
faith that there is a reasonable likelihood that a Product Liability Claim could have a
material negative affect on Gamunex, then Talecris, shall have the right, but not the
obligation, to assume the sole defense of such Product Liability Claim.

 

 

	 	(d)	 	Procedure. Each Party shall consult with the other Party on all
material aspects of the defense, including without limitation settlement, of such
Product Liability Claim, and the Parties shall cooperate fully with each other in
connection therewith. To facilitate the defense of any Product Liability Claim, the
Parties shall mutually select a law firm to represent them in the joint defense of such
claim as soon as practicable following the Effective Date of this Agreement. In
furtherance of the Parties’ cooperation, the Parties will consult with each other
regarding strategic decisions, including without limitation the changing of counsel and
defense of each Product Liability Claim. Any settlement of a Product Liability Claim
that would admit liability on the part of any Party or its Affiliates or Agents, or
that would involve any relief other than the payment of money damages, shall be subject
to the prior written approval of both Parties, such approval not to be unreasonably
conditioned, withheld or delayed. All damages and expenses (including attorney’s fees)
incurred in connection with the defense of a Product Liability Claim shall be allocated
between the Parties in accordance with Sections 12.03(a) and 12.03(b).

	12.04	 	Notice. Should any claim arise which could reasonably be expected to lead to a
claim for indemnification, the Party seeking indemnification (the “Indemnified Party”) shall
promptly Notify the other Party (the “Indemnifying Party”) of the claim and the facts
constituting the basis for such claim. The omission of such Notice shall not relieve either
Party from its indemnification obligations under this Article 12, except to the extent the
other Party can establish actual prejudice and direct damages as a result thereof.
	 
	12.05	 	Indemnification Not Sole Remedy. Each Party hereby acknowledges that the
indemnification provided for under this Article 12 shall in no manner limit, restrict or
prohibit (unless liability is otherwise expressly limited by the terms of this Agreement)
either Party from seeking any recovery or remedy provided at law or in equity from the other
Party in connection with any breach or default by such other Party of any representation,
warranty or covenant hereunder.
	 
	12.06	 	Guarantor. Parent agrees to act as a third party guarantor (“Guarantor”) of
Emergent for the indemnities provided by Emergent to Talecris under this Article 12 and the
payment obligations of Emergent set forth in Section 7.05(a). Upon Emergent’s default of its
indemnity obligations hereunder or its payment obligations set forth in Section 7.05(a),
Guarantor agrees to guarantee such obligation as its own. Guarantor agrees that no amendment,
termination or other release, other than Talecris expressly releasing Guarantor in writing,
shall in any way alleviate its obligations under this Section 12.06 and Guarantor hereby
waives any notice of any such amendment, termination or other release. Guarantor hereby
agrees to give written notice to Talecris within ten (10) days of: (i) any notice received or
action filed alleging the insolvency or bankruptcy of Guarantor; (ii) any notice received or
action filed alleging the insolvency or bankruptcy of Emergent; or (iii) any other event which
would otherwise reasonably prevent Guarantor from fulfilling its obligations under this
Section 12.06.

 

 

ARTICLE 13 — CONFIDENTIALITY

     Confidentiality. From the Effective Date through the seventh (7th) anniversary of the
termination or expiration of this Agreement, each Party shall keep confidential and use solely for
purposes of performing its obligations under this Agreement, and shall cause its respective
Affiliates, Sublicensees and their respective officers, directors, employees and agents to keep
confidential and to so use, all information proprietary or confidential to the other Party that has
been acquired by it through its participation in the negotiation and performance of this Agreement.
The foregoing restriction shall not apply to information that (a) is or hereafter becomes
generally available to the public other than by reason of any default with respect to
confidentiality under this Agreement, (b) is hereafter disclosed to such Party by a Third Party who
is not in default of any confidentiality obligation to the other Party, (c) is hereafter developed
by or on behalf of such Party, without reliance on confidential information acquired prior to the
date hereof, (d) is required to be disclosed in compliance with Applicable Law or order by a court
or other governmental or Regulatory Authority or body having competent jurisdiction, provided that
reasonable measures shall be taken to assure confidential treatment of such information, or (e) is
provided by such Party under appropriate terms and conditions, including confidentiality provisions
equivalent to those in this Agreement, to Third Parties for consulting, accounting, legal and
similar purposes, or to any permitted assignee of this Agreement, to the extent considered
reasonably necessary to facilitate the assignment. For purposes of clarity, any information
related to the composition and/or utility of Finished Product, the Emergent Specifications, and
Fill/Finish Specifications shall be deemed confidential information of Emergent hereunder. The
content of the Talecris BLA sections and the Gamunex Specifications shall be deemed confidential
information of Talecris hereunder. Each Party recognizes that any violation of this
confidentiality provision may cause the other Party irreparable harm and agrees that the other
Party may be entitled, in addition to any other right or remedy it may have, at law or in equity,
to an injunction without the posting of any bond or other security, enjoining the disclosing Party,
its Affiliates, Sublicensees and their respective officers, directors, employees and agents from
any violation or potential violation of this Article.

ARTICLE 14 — DISPUTE RESOLUTION AND LITIGATION

	14.01	 	Dispute Resolution Procedures. Except for matters to be resolved pursuant to
Sections 4.01(c)(v)(B), 5.02(d) or 9.03, any dispute arising out of, relating to, or having
any connection with this Agreement (including any question relating to its existence,
validity, interpretation, performance, or termination) (“Dispute”) shall be resolved pursuant
to the procedures set forth in this Article. If either Party fails to observe the procedures
of this Article, as may be modified by the written agreement of the Parties, the other Party
may bring an action for specific performance.

	 	(a)	 	Negotiation. In the event of a Dispute, the affected Party shall
notify the other Party of the Dispute in writing, and the Parties shall negotiate in
good faith, for a period of thirty (30) days (or such longer period as may be agreed by
the Parties) from the issuance of the Notice (the “Notice Date”), to resolve the
Dispute without the intervention of a neutral party or a court.

 

 

	 	(b)	 	Mediation. If the Dispute remains unresolved within sixty (60) days
after the Notice Date, either Party may request that the Parties submit the Dispute to
non-binding mediation before a mutually acceptable neutral mediator by sending written
Notice to the other Party. If the other Party agrees to mediate, the Parties shall
attempt to resolve the Dispute through mediation until one of the following occurs: (i)
the Parties reach a written settlement; (ii) the mediator notifies the Parties in
writing that they have reached an impasse; (iii) the Parties agree in writing that they
have reached an impasse; or (iv) the Parties have not reached a settlement within one
hundred twenty (120) days after the Notice Date.
	 
	 	(c)	 	Litigation. If the Parties fail to resolve the Dispute through
mediation, or if the Dispute is, in any event, not resolved within one hundred eighty
(180) days after the Notice Date, each Party shall have the right to pursue any other
remedies legally available to resolve the Dispute.
	 
	 	(d)	 	Statute of Limitations. The Parties agree that all applicable statutes
of limitation and time-based defenses (such as estoppel and laches) shall be tolled
while the procedures set forth in Sections 14.01(a) and 14.01(b) are pending. The
Parties shall take any actions necessary to effectuate this result.

	14.02	 	Other Rights.

	 	(a)	 	Exception for Additional Disputes. In the event that the Parties are
involved in ongoing litigation of one or more Disputes that already have been through
the dispute resolution process set forth in Sections 14.01(a)—(c), the Parties are not
required to submit additional Disputes to negotiations pursuant to Section 14.01(b), as
long as that litigation remains pending.
	 
	 	(b)	 	Provisional Remedies. Notwithstanding the dispute resolution
procedures described above, either Party may seek a preliminary injunction or other
provisional equitable relief if, in its reasonable judgment, such action is necessary
to avoid irreparable harm.
	 
	 	(c)	 	Termination. For the avoidance of doubt, nothing in this Article shall
preclude, interfere with or modify either Party’s rights under Article 10 with respect
to the termination of this Agreement.

	14.03	 	Governing Law. This Agreement and any and all 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.

ARTICLE 15 — GENERAL PROVISIONS

	15.01	 	Notice. Notices and other communications (each, a “Notice”) provided herein shall
be in writing and shall be delivered by hand or overnight courier service, mailed or sent by
facsimile (with receipt confirmed) as follows:

 

 

	 	 	 
	 

	 	If to Emergent, to:
	 
	 	 
	 

	 	Emergent Product Development Gaithersburg Inc.
	 

	 	300 Professional Drive
	 

	 	Gaithersburg, MD 20879
	 
	 	 
	 

	 	Attn: General Counsel
	 

	 	or
	 

	 	Attn: Accounts Payable (for invoices only)
	 
	 	 
	 

	 	with copies (except as to invoices), which shall not constitute notice hereunder, sent to:
	 
	 	 
	 

	 	Wilmer Cutler Pickering Hale and Dorr LLP
	 

	 	1899 Pennsylvania Avenue, NW
	 

	 	Washington, DC 20006
	 

	 	Facsimile: (202) 663-6363
	 
	 	 
	 

	 	Attn: Van W. Ellis
	 
	 	 
	 

	 	If to Talecris, to:
	 
	 	 
	 

	 	Talecris BioTherapeutics, Inc.
	 

	 	79 T.W. Alexander Drive
	 

	 	4101 Research Commons
	 

	 	PO Box 13887
	 

	 	Research Triangle Park
	 

	 	North Carolina 27709
	 
	 	 
	 

	 	Attn: VP of Law, General Counsel

	 	 	All Notices and other communications given to any Party in accordance with the provisions of
this Agreement shall be deemed to have been given on the date of receipt if delivered by
hand or overnight courier services or sent by facsimile (with receipt confirmed by telephone
or by facsimile machine), or on the date five (5) Business Days after dispatch by certified
or registered mail (postage prepaid) if mailed, in each case delivered, sent or mailed
(property addressed) to such Party at its address as set forth in this Section 15.01, or to
such other address that such Party may have Notified to the other Party from time to time.
	 
	15.02	 	Entire Agreement. This Agreement and the Exclusivity Agreement (including all
attachments hereto and thereto) constitute the entire agreement among the Parties with respect
to the matters set forth herein, and supersede all prior agreements and understandings, both
written and oral, among the Parties with respect thereto, including without limitation the
Letter of Intent, dated as of April 5, 2006 (as amended), between the Parties. In the event
of any conflict or discrepancy between the terms of the Quality Agreement or the Exclusivity
Agreement and this Agreement, the terms of this Agreement shall control.

 

 

	15.03	 	Covenant of Further Assurances. The Parties covenant and agree that, subsequent to
the execution and delivery of this Agreement and without any additional consideration, each of
the Parties shall execute and deliver any further legal instruments and perform such acts
which are or may become reasonably necessary to effectuate the purposes of this Agreement.
	 
	15.04	 	Waivers; Amendment. The failure of either Party to insist, in any one or more
instances, upon the performance of any of the terms, covenants or conditions of this Agreement
or to exercise any right hereunder, shall not be construed as a waiver or relinquishment of
the future performance of any such term, covenant or conditions or the future exercise of such
right, and the obligation of the other Party with respect to such future performance shall
continue in full force and effect. No item or provision of this Agreement may be altered,
amended or waived except by a writing signed by both Parties.
	 
	15.05	 	Relationship. Talecris is an independent contractor engaged by Emergent for the
provision of the Finished Product. Nothing in this Agreement shall constitute Talecris as an
employee, agent or general representative of Emergent. This Agreement shall not constitute
either Party as the legal representative or agent of the other, nor shall either Party have
the right or authority to assume, create or incur any liability or any obligation of any kind,
express or implied, against, or in the name of or on behalf of, the other Party. This
Agreement shall not constitute, create or in any way be interpreted as a joint venture,
partnership or formal business organization of any kind.
	 
	15.06	 	Publicity. Except as otherwise required by Applicable Law, neither Party shall use
the other’s name or refer to it directly or indirectly in an advertisement, news release or
release to any professional or trade publication or issue any news release relating to this
Agreement, without the prior written approval from such Party for such use or release, which
approval shall not be unreasonably withheld, conditioned or delayed. The Parties agree that a
news release with respect to the consummation of this transaction and the details thereof will
be made, the content, form and timing of which shall be reasonably agreed between the Parties.
	 
	15.07	 	Severability. If, under Applicable Law, any provision of this Agreement is invalid
or unenforceable, or otherwise directly or indirectly affects the validity of any other
material provision(s) of this Agreement (such invalid or unenforceable provision, a “Severed
Clause”), this Agreement shall endure except for the Severed Clause. The Parties shall
consult one another and use Commercially Reasonable Efforts to agree upon a valid and
enforceable provision that is a reasonable substitute for the Severed Clause in view of the
intent of this Agreement.
	 
	15.08	 	Assignment. This Agreement may not be assigned by either Party without the prior
written consent of the other Party; provided, however, that either Party may assign its right
to receive payment hereunder without prior consent of the other Party, but provided it
Notifies such other Party of such assignment within three (3) Business Days. In addition,
either Party may assign this Agreement, without the other Party’s prior written consent, to
any Affiliate or in connection with an acquisition, merger or sale of all or substantially all
of the stock, assets or business to which this Agreement pertains.

 

 

	15.09	 	Subcontracting. Talecris shall not subcontract or otherwise delegate any of its
obligations under this Agreement, either to an Affiliate or a Third Party, if such
subcontracting or delegation would require the manufacturing of additional Validation Lots for
Finished Product. If such subcontracting or delegation would not require the manufacturing of
additional Validation Lots of Finished Product, Talecris may subcontract or delegate any of
its obligations hereunder to an Affiliate or Third Party, provided, that (a) Talecris Notifies
Emergent of such proposed subcontracting arrangement, including without limitation the
identity of the proposed subcontractor, the location of such proposed subcontractor’s
facilities, and a reasonably detailed description of the terms of such proposed subcontracting
arrangement as it relates to the Finished Product, (b) Talecris procures for Emergent a
reasonable opportunity to conduct a quality audit of the facilities proposed to be used by
such proposed subcontractor in performing its obligations with respect to Finished Product, at
a time reasonably satisfactory to Emergent, (c) Talecris guarantees to Emergent the
performance of any of its obligations which it fulfills through such subcontracting and
remains primarily liable for the performance of such obligations, and (d) Talecris obtains
Emergent’s prior written consent, which shall not be unreasonably withheld, conditioned or
delayed. Talecris shall bear all costs associated with or arising as a result of any such
permitted subcontracting by Talecris (including, without limitation, costs associated with any
regulatory filings which may be required to be submitted to any Regulatory Authorities with
respect to Finished Product), and shall reimburse Emergent for such costs to the extent
incurred by Emergent.
	 
	15.10	 	Headings. The headings used in this Agreement are included for convenience only and
are not to be used in construing or interpreting this Agreement.
	 
	15.11	 	Force Majeure. Subject to Section 10.02(d), if either Party is impeded in
fulfilling its undertakings in accordance with this Agreement by circumstances beyond its
reasonable control, such as, but not limited to, labor conflict, lightening striking, acts of
God, fire, war, mobilization or unforeseen military call-up of a large magnitude, requisition,
confiscation, commandeering, public decrees, riots, insurrections, terrorism, general shortage
of transport, goods or energy, and faults or delays in deliveries from subcontractor or
suppliers caused by any circumstances referred to in this Section 15.11, the impediment shall
be considered a “Force Majeure” condition and the Party shall be exempted from liability for
delays due to such reasons; provided, however, that it Notifies the other Party thereof
without undue delay after such a circumstance has occurred. Upon such Notice, the Parties
shall agree upon a reasonable extension of the time for performance, not to exceed an
extension equal to the period the Force Majeure condition continues to exist.
	 
	15.12	 	Counterparts. This Agreement may be executed in any number of counterparts, each of
which will be deemed an original, but all of which together will constitute one and same
instrument.
	 
	15.13	 	LIMITATION OF DAMAGES. EXCEPT WITH RESPECT TO A PARTY’S INDEMNIFICATION OBLIGATIONS
UNDER ARTICLE 12 HEREUNDER OR A BREACH OF A PARTY’S CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE

 

 

	 	 	13, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY, AND EACH PARTY SHALL
PROCURE THAT NONE OF ITS AFFILIATES SHALL MAKE ANY CLAIM AGAINST THE OTHER PARTY (OR ITS
AFFILIATES) FOR ANY LOST PROFITS, LOSS OF BUSINESS, LOSS OF CONTRACTS, DIMINISHED GOODWILL,
DIMINISHED REPUTATION, OR CONSEQUENTIAL, INCIDENTAL, SPECIAL, PUNITIVE OR OTHER INDIRECT
DAMAGES ARISING UNDER OR IN CONNECTION WITH THIS AGREEMENT, THE AIG, THE FINISHED PRODUCT
AND/OR THE PROCESSING OF FINISHED PRODUCT.
	15.14	 	Talecris Limitation on Liability. To the fullest extent permitted by law, and except
as otherwise expressly provided in this Agreement in Section 12.01 (b) and (c) and Third Party
Claims relating to Gamunex® Products, Talecris’ aggregate liability for any and all
Claims, losses, costs or damages whatsoever arising out of or resulting from or in any way
related to the Processing or this Agreement from any cause or causes, including but not
limited to the negligence, strict liability, breach of contract or warranty (express or
implied) of Talecris or Talecris’ officers, directors, employees, agents or consultants shall
be limited to the greater of the (i) Processing Fees paid by Emergent during the twelve (12)
months prior to the date the Claim, loss, cost, or damage arose, (ii) the Commercial Volume
Commitment for the Contract Year during which such Claim, loss, cost or damage arose, or (iii)
the Firm Commitment for the Contract Year during which such Claim, loss, cost or damage arose.
	 
	15.15	 	Exhibits. In the event that an Exhibit referenced herein is not completed by the
Effective Date, such Exhibit shall be completed as soon as practicable following the Effective
Date, but no later than forty-five (45) days thereafter, and upon approval in writing by both
Parties, shall be attached hereto.

     IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their respective
officers hereunto duly authorized as of the Effective Date.

EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.

	 	 	 	 	 
	 
	 	 	 	 
	By:

	 	     /s/ R. Don Elsey
 

	 	 
	 

	 	     Name: R. Don Elsey	 	 
	 

	 	     Title: Treasurer	 	 

TALECRIS BIOTHERAPEUTICS, INC.

 

 

	 	 	 	 	 
	 
	 	 	 	 
	By:

	 	     /s/ Alberto Martinez
 

	 	 
	 

	 	     Name: Alberto Martinez	 	 
	 

	 	     Title: President and CEO	 	 

With respect to the Guarantor obligations set forth in Section 12.06 only, with the consent of the
other Parties as evidenced by their signatures above, the following party joins as a signatory to
this Agreement.

EMERGENT BIOSOLUTIONS INC.

	 	 	 	 	 
	 
	 	 	 	 
	By:

	 	     /s/ Daniel J. Abdun-Nabi
 

	 	 
	 

	 	     Name: Daniel J. Abdun-Nabi	 	 
	 

	 	     Title: Sr. V.P. and General Counsel	 	 

 

 

EXHIBIT A

Gamunex Specifications

	 	 	 
	Test	 	Specification
	Protein concentration

	 	[**]
	Appearance: color

	 	[**]
	Appearance: clarity

	 	[**]
	Caprylate concentration

	 	[**]
	Anticomplement Activity

	 	[**]
	Anti-A

	 	[**]
	Anti-B

	 	[**]
	pH (1% protein solution)

	 	[**]
	Glycine concentration

	 	[**]
	Protein composition (CZE)

	 	[**]
	MW Distribution: Aggregate

	 	[**]
	MW Distribution: Monomer + Dimer

	 	[**]
	MW Distribution: Fragment

	 	[**]
	Prekallikrein activator

	 	[**]
	Sterility USP

	 	[**]
	Pyrogen USP

	 	[**]
	General Safety Testing

	 	[**]

[**]

 

 

EXHIBIT A-1

Emergent Specifications

	 	 	 
	Test	 	Specification
	Post Packaging Identity: [**]

	 	[**]
	Potency: [**]

	 	[**]

 

 

EXHIBIT B

Talecris Patent Rights

1. United States Patent No. 6,955,917, issued on October 18, 2005, entitled “Chromatographic method
for high-yield purification and viral inactivation of antibodies”.

	 	 	 
	Inventors:

	 	 Alred; Patricia (Fredrick, MD); Cook; Scott A.
	 

	 	 (Apex, NC); Lebing; Wytold R. (Clayton, NC); Lee;
	 

	 	 Douglas C. (Raleigh, NC); Paul; Hanns-Ingolf
	 

	 	 (Leverkusen, DE); Radtke; Klaus-Peter (Apex, NC)
	Assignee:

	 	 Bayer Healthcare LLC (Tarrytown, NY)
	Appl. No.:

	 	 270918
	Filed:

	 	 October 15, 2002

2. United States Patent No. 6,307,028, issued on October 23, 2001, entitled “Chromatographic method
for high-yield purification and viral inactivation of antibodies”.

	 	 	 
	Inventors:

	 	 Lebing; Wytold (Clayton, NC); Alred; Patricia (New Market, MD);
	 

	 	 Lee; Douglas C. (Apex, NC); Paul; Hanns-Ingolf (Cary, NC)
	Assignee:

	 	 Bayer Corporation Incorporated (Indiana, PA)
	Appl. No.:

	 	 270724
	Filed:

	 	 March 17, 1999

3. United States Patent No. 5,886,154, issued on March 23, 1999, entitled “Chromatographic method
for high-yield purification and viral inactivation of antibodies”.

	 	 	 
	Inventors:

	 	 Lebing; Wytold R. (1304 Pine Trail, Clayton, NC 27520-9324);
	 

	 	 Alred; Patricia (9890 Washington Blvd. Apt. 404, Gaithersberg,
	 

	 	 MD 20878); Lee; Doug C. (116 Altair Cir., Apex, NC 27502); Paul;
	 

	 	 Hanns-Ingolf (1107 Queenferry Rd., Cary, NC 27511)
	Assignee:

	 	 [                                        ]
	Appl. No.:

	 	 879362
	Filed:

	 	 June 20, 1997

 

 

Exhibit C

Talecris

          BIOTHERAPEUTICS

	 	 	 
	 

	 	8368 U.S. 70 West
	 

	 	Clayton, NC 27520
	 
	 	 
	 

	 	David Sorrell
	 

	 	Senior Contract Manager
	 

	 	Tel: 919.359.7094
	 

	 	Fax: 919.359.7174
	 

	 	david.sorrell@talecris.com

June 14, 2006

Emergent BioSolutions

Nili Leffers

300 Professional Dr, Suite 250

Gaithersburg, MD 20879

Dear Nili,

The purpose of this data packet is to provide three documents that govern the receipt of AIG
Anthrax Plasma. The documents are:

	 	1.	 	Purchase Specification — Source Plasma — Anthrax (AX), Revision New, SAP # 08937351,
Effective Date: 6/14/2006
	 
	 	2.	 	SOP — Plasma Supplier Supplemental Directions, Revision 12, SOP # CS-000-BE-053,
Effective Date: 03/31/2006
	 
	 	3.	 	Purchase Specification — General Specification — Source Plasma, Revision 23, Effective
Date: 03/31/2006

These are the documents that govern the shipment of AIG plasma to the Clayton Talecris facility.

Please distribute as needed.

Sincerely,

	 	 	 
	/s/ David M. Sorrell
	 	 
	 
	 

David SorrelI,          6/14/06

	 	 
	Contract Manager
	 	 

www.talecris.com

 

 

	 	 	 	 	 
	Talecris

	 	PURCHASE SPECIFICATION
	 	SAP MATERIAL #: 08937351
	BIOTHERAPEUTICS

	 	 	 	REVISION: NEW
	 

	 	TITLE: SOURCE PLASMA — ANTHRAX (AX)
	 	PAGE 1 of 2

	 	 	 	 	 	 	 
	/s/ Amy W. Durham
	 	6-12-06
	 	/s/ John W. Parrish
	 	6-12-2006
	 
	 	 
	 	 
	 	 
	Document Owner
	 	Date
	 	Quality Approver
	 	Date

	 	 	 	 	 	 	 
	Supercedes:

	 	N/A
	 	Date Effective:
	 	JUN 14 2006
	 

	 	 
	 	 	 	 

	1.	 	PURPOSE

	 	1.1.	 	To describe specific requirements, in addition to those described in the Source
Plasma, General Specification, for Source Plasma – Anthrax.

	2.	 	REFERENCE(S)

	 	2.1.	 	Source Plasma – General Specification
	 
	 	2.2.	 	CS-000-BE-053, Plasma Supplier Supplemental Directions
	 
	 	2.3.	 	CS-000-BH-010, Supplier Quality – Notification, Evaluation and Approval of
Plasma Suppliers and Service Providers

	3.	 	DEFINITIONS

	 	3.1.	 	Source Plasma Type – Anthrax (AX) - Refers to plasma collected by approved
plasmapheresis method from donors with naturally occurring or artificially stimulated
antibody levels for Anthrax.
	 
	 	3.2.	 	SQID – Supplier Quality Information Database - Database maintained by Talecris
Supplier Quality that contains pertinent information and current status of each
collection facility, test laboratory, and plasma transportation carriers.

	4.	 	GENERAL REQUIREMENTS

	 	4.1.	 	Plasma collection must be in approved bottles only.
	 
	 	4.2.	 	Plasma collection is non-EU approved only.

	5.	 	SPECIAL REQUIREMENTS

	 	5.1.	 	Emergent BioSolutions is the purchaser of the [**] Anthrax (AX) plasma.
Emergent is responsible for contracts with the individual plasma suppliers of the AX
plasma and ensuring that these plasma centers and product meet the requirements listed
in this specification and in the Source Plasma, General Specification for Source
Plasma. Moreover, Emergent is responsible for the transport of the plasma to Talecris
receiving dock.
	 
	 	5.2.	 	The plasma donor centers supplying the AX plasma must also be on the Talecris
approved centers listing in the SQID, as well as the testing labs associated with the
plasma testing.
	 
	 	5.3.	 	The AX plasma under this material number will be processed together to form a
manufacturing pool, as modeled by Talecris. Only [**] will be further processed from an
AX pool. The [**] will be further manufactured into IGIV-C product.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in

connection with matters authorized by Talecris and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

	 	PURCHASE SPECIFICATION
	 	SAP MATERIAL #: 08937351
	BIOTHERAPEUTICS

	 	 	 	REVISION: NEW
	 

	 	TITLE: SOURCE PLASMA — ANTHRAX (AX)
	 	PAGE 2 of 2

	 	5.4.	 	Plasma from donors identified with [**] Anthrax or AX antibodies (as judged by
Emergent) may be designated as AX plasma.

	6.	 	NAT TESTING REQUIREMENTS

	 	6.1.	 	The following chart lists the required NAT testing and the material numbers for
Anthrax high titer plasma. Note: Only plasma tested for HCV, HIV-1, HBV and Parvo B19
by NAT is acceptable to ship to Talecris.

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SAP (Required)	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Material	 	EU	 	HCV by	 	HIV-1 by	 	 	 	 	 	Parvo B-19 by	 	 
	Numbers	 	ELIGIBLE	 	NAT	 	NAT	 	HBV by NAT	 	NAT	 	Bottles
	08937351
	 	 	 	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	Bottles

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in

connection with matters authorized by Talecris and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

	 	STANDARD OPERATING PROCEDURE
	 	SOP #: CS-000-BE-053
	BIOTHERAPEUTICS

	 	 	 	REVISION: 12
	 

	 	TITLE: Plasma Supplier Supplemental Directions
	 	PAGE 1 of 13

	 	 	 	 	 	 	 
	/s/ Amy W. Durham
	 	2-28-06
	 	/s/ John W. Parrish
	 	2-28-2006
	 
	 	 
	 	 
	 	 
	Document Owner
	 	Date
	 	Quality Approver
	 	Date

	 	 	 	 	 	 	 
	Supercedes:

	 	CS-000-AR-107
	 	Effective Date:
	 	MAR 31 2006
	 

	 	 
	 	 	 	 

	1.	 	PURPOSE

	 	1.1.	 	This document outlines specific directions that supplement the minimum
requirements listed in the Talecris General Specification — Source Plasma.

	2.	 	SCOPE

	 	2.1.	 	These directions are applicable to all plasma that is procured and designated
for shipment to Talecris.
	 
	 	2.2.	 	This document is to be used by plasma suppliers that sell plasma to Talecris.
	 
	 	2.3.	 	This SOP is distributed by Clayton QO-Plasma to all Talecris Plasma Operations
Account Managers.
	 
	 	2.4.	 	This SOP contains Talecris-required NDP and Packing List Summary forms that are
completed by plasma centers for shipments to Talecris. Changes to these forms must be
documented through a revision of this SOP.

	3.	 	RESPONSIBILITY

	 	3.1.	 	Talecris QO-Plasma:

	 	3.1.1.	 	Communicates to plasma suppliers and appropriate Talecris departments (e.g.,
Plasma Ops, QO Compliance) any quality issues (discrepancies) with received
product.

	 	3.2.	 	Talecris Plasma Operations Account Manager monitors plasma suppliers’
compliance and adherence to regulatory agency requirements and to the Talecris General
Specification — Source Plasma.

	 	3.2.1.	 	Provides supplier with most current revisions of this document, associated
forms, and other SOPs/specifications.
	 
	 	3.2.2.	 	May initiate changes to this SOP and other plasma supplier documents and
participates in the review process of revisions.

	 	3.3.	 	Plasma Supplier assures that all conditions of the General Specification -
Source Plasma and supply contract are met.
	 
	 	3.4.	 	Talecris Plasma Operations Technical Services Manager approves the use of
specific plasma collection materials and supplies, all packaging and shipping
materials, samples tubes, labels and bar code systems used by suppliers. Successful
completion of materials clearance testing is required prior to approval for all
specific plasma collection and supply materials. These functions may be performed by
the Talecris Plasma Operations Account Managers in the absence of the Technical
Services Manager.

 

 

	 	 	 	 	 
	Talecris

	 	STANDARD OPERATING PROCEDURE
	 	SOP #: CS-000-BE-053
	BIOTHERAPEUTICS

	 	 	 	REVISION: 12
	 

	 	TITLE: Plasma Supplier Supplemental Directions
	 	PAGE 2 of 13

	 	3.5.	 	Talecris QO Manager, Supplier Quality determines and communicates all changes in
plasma supplier status and/or services to Talecris, and maintains the appropriate
documentation files for status of suppliers, collection and testing facilities.
	 
	 	3.6.	 	Talecris, Regulatory Affairs coordinates implementation of any new regulatory
requirements.
	 
	 	3.7.	 	Talecris Plasma Receiving receives all incoming plasma shipments and handles
all correspondence related to inventory control.
	 
	 	3.8.	 	QO Document Management, Clayton, maintains and revises the NDP and PLS forms as
requested.

	4.	 	REFERENCES

	 	4.1.	 	CS-000-BE-057 — Supplier Quality — Method For Evaluating The Suitability Of
Source Plasma Collection Facilities And Test Laboratories
	 
	 	4.2.	 	Talecris General Specification — Source Plasma

	5.	 	DEFINITIONS

	 	5.1.	 	ITS: Incident Tracking System. Used by Talecris to track discrepancy reports
for plasma not yet processed (RMRs) and only impacting processed material (ITS).
	 
	 	5.2.	 	NDP: Notification for Destruction of Plasma form. Submitted to Talecris in the
event plasma unit removal or disposition is required.
	 
	 	5.3.	 	NDDR: National Donor Deferral Registry
	 
	 	5.4.	 	QO-Plasma: Quality Operations Plasma Business Unit
	 
	 	5.5.	 	PPL: Plasma Packing List for individual plasma cases
	 
	 	5.6.	 	PLS: Packing List Summary form. Separate PLS forms are submitted for each
vendor batch number.
	 
	 	5.7.	 	RMR: Raw Material Report. A report used to document discrepancies against
plasma not yet processed (pooled).
	 
	 	5.8.	 	RTL: Talecris Raleigh Test Lab
	 
	 	5.9.	 	SAP Material Number: The SAP material number replaces the plasma item number.
The SAP material number (referred to as plasma material number) identifies the plasma
type, collection in bottles, level of testing, and whether or not the plasma is EU
eligible.
	 
	 	5.10.	 	Vendor Batch Number: Identifies the shipment, to Talecris. The vendor batch
number is a unique identifier that is NEVER duplicated at the same center. Whenever a
shipment comprises more than one plasma type, a unique vendor batch number must be
assigned to each plasma type within the shipment. The first four (4) characters of the
Vendor Batch Number must be the donor center’s NDDR number.
	 
	 	5.11.	 	Working Day: Any scheduled workday.

 

 

	 	 	 	 	 
	Talecris

	 	STANDARD OPERATING PROCEDURE
	 	SOP #: CS-000-BE-053
	BIOTHERAPEUTICS

	 	 	 	REVISION: 12
	 

	 	TITLE: Plasma Supplier Supplemental Directions
	 	PAGE 3 of 13

	6.	 	REQUIREMENTS

	 	6.1.	 	Materials/Reagents — Refer to Talecris General Specification
	 
	 	6.2.	 	Equipment — Refer to Talecris General Specification
	 
	 	6.3.	 	Frequency

	 	6.3.1.	 	This procedure is to be used to verify each shipment of plasma sent to
Talecris complies with all applicable regulatory requirements, Talecris General
Specification — Source Plasma, and any plasma material-number-specific Talecris
plasma specifications.
	 
	 	6.3.2.	 	Copies of this SOP are sent to Plasma Operations Account Managers each time
this SOP is revised. From the date this SOP is approved, the effective date will
be stamped one month in advance and sent to plasma suppliers to conduct
training.
	 
	 	6.3.3.	 	Master copies of NDP and PLS forms are sent to Plasma Operations Account
Managers each time the forms are modified.

	7.	 	PROCEDURE

	 	7.1.	 	Vendor Approval

	 	7.1.1.	 	Talecris must approve each plasma collection, testing, storage and transport
establishment prior to shipment of plasma. This approval is documented
internally at Talecris in accordance with CS-000-BE-057 and externally in
written correspondence to the plasma supplier.

	 	7.2.	 	Plasma Identification

	 	7.2.1.	 	A Talecris-approved bar code labeling system must be used to generate all
labels used for plasma donor, unit, sample, and case identification. Talecris
provides appropriate scan sheets for use with the Sigma Bar Code Printer System.
Alternate bar-coding systems are acceptable for use if approved, in writing, by
Talecris Plasma Operations Technical Services Manager.
	 
	 	7.2.2.	 	Correct plasma material number assignment is critical to Talecris receipt and
manufacturing operations. Usage decisions and traceability of plasma is
dependent on plasma material numbers. The plasma material number identifies the
plasma type, that the plasma is collected in bottles, the testing level of the
plasma, and EU approval status. Refer to Talecris’ General Specification -
Source Plasma for required plasma material number legend.
	 
	 	7.2.3.	 	A unique vendor batch number must be assigned to each plasma type within the
shipment.

	 	a.	 	The unique vendor batch number for the shipment
must be for only one center (combining plasma units from different
centers in one case is unacceptable).

 

 

	 	 	 	 	 
	Talecris

	 	STANDARD OPERATING PROCEDURE
	 	SOP #: CS-000-BE-053
	BIOTHERAPEUTICS

	 	 	 	REVISION: 12
	 

	 	TITLE: Plasma Supplier Supplemental Directions
	 	PAGE 4 of 13

	 	7.3.	 	Plasma Unit Documentation and Error Correction of PPL

	 	7.3.1.	 	Record Keeping
	 
	 	 	 	Adhere to the following instructions when making entries or correcting
errors on packing lists and other records that are sent to Talecris:

	 	a.	 	Make all entries on all documents in
permanent, indelible black or blue ink.
	 
	 	b.	 	It is unacceptable to use felt-tipped or gel
pens on documents sent to Talecris.
	 
	 	c.	 	All entries on all documents and photocopies
must be legible.
	 
	 	d.	 	If a space is inappropriate for a given step,
enter N/A (Not Applicable). If a space becomes inappropriate due to
special circumstances, enter N/A and a brief explanation. A diagonal
line may be used across unused spaces. All entries must be initialed
and dated.
	 
	 	e.	 	When a copy is sent as documentation, it must
bear the statement, “This is a true and accurate copy of the
original.” The statement must be initialed and dated by center
management.

			
	NOTE:	 	If the entire packing list is a copy, one stamp on the PLS is adequate. If
subsequent changes are made on plasma units or cases, the affected pages must be stamped,
initialed, and dated.

	 	f.	 	Use of liquid paper, white out, or any
similar material that obliterates errors is unacceptable.
	 
	 	g.	 	Application of one plasma unit control number
label over another is unacceptable.

	 	7.3.2.	 	Removal of a Plasma Unit

	 	a.	 	When a plasma unit is removed from a case,
two initials and the date of action are required on the PPL to
verify that the unit has been removed. Talecris QO Plasma may
approve, in writing, an alternate documentation method for unit
removal.

	 	7.3.3.	 	Error Correction

	 	a.	 	Draw a single line through the error so that
the words (or figures, etc.) can still be read. Initial and date
line out. Rewrite correct information.
	 
	 	b.	 	If a plasma unit is lined out in error, it is
not acceptable to Talecris. For Talecris to accept such a plasma
unit, all correct unit information must be re-entered on the PPL
with a detailed explanation of why the line out occurred. Comment
must also be initialed and dated.

 

 

	 	 	 	 	 
	Talecris

	 	STANDARD OPERATING PROCEDURE
	 	SOP #: CS-000-BE-053
	BIOTHERAPEUTICS

	 	 	 	REVISION: 12
	 

	 	TITLE: Plasma Supplier Supplemental Directions
	 	PAGE 5 of 13

	 	7.4.	 	Unacceptable Plasma Units

	 	7.4.1.	 	Plasma units that test positive, reactive, or elevated for any of the
required tests must not be shipped to Talecris. Actions to be taken and
lookback requirements must be followed as outlined in Talecris General
Specification — Source Plasma, Appendix A, Table of Actions.
	 
	 	7.4.2.	 	If in error, a viral marker reactive or NAT reactive unit is shipped to
Talecris or unit from a donor diagnosed with CJD/vCJD is shipped to Talecris,
immediately forward the NDP by fax to 919-359-4428. Additionally, phone the
Talecris QO Plasma Supervisor at 919-359-4581 to initiate unit trace.
	 
	 	7.4.3.	 	Plasma units with unacceptably high hemoglobin concentrations must not be
shipped to Talecris. Evaluate hemoglobin concentration at time of collection
using the Talecris Hemoglobin Comparator by following the instructions for use
printed on the card. Note that the color comparison must be performed against
the well-mixed, liquid contents of the plasma collection bottle prior to
freezing.

	 	7.5.	 	Notification for Destruction of Plasma (NDP)

	 	7.5.1.	 	As detailed in the Talecris General Specification- Source Plasma, Appendix A
 — Table of Actions, following receipt of a repeat reactive test result or valid
post-donation information, complete the plasma center entries on the NDP form
for notification to Talecris of needed unit destruction. It is critical for
unit traceability at Talecris that all Plasma Item or SAP material numbers
reported on the NDP form reflect the actual Plasma Item or SAP material numbers
under which the plasma was shipped. Due to added NAT level testing, Plasma Item
and SAP material numbers have changed over time.
	 
	 	7.5.2.	 	Concerning instances of owner transfer of plasma centers, the NDDR and
Talecris center code reported on the NDP sent to Talecris must reflect the
NDDR/center code at the time of unit collection (not at time of reporting).
	 
	 	7.5.3.	 	The NDP must be faxed to Clayton Plasma Receiving within 3 working days upon
receipt of a reactive or positive test result for a donor from whom prior or
subsequent units have been shipped to Talecris (lookbacks). Reference the
Talecris fax number on the NDP form.
	 
	 	7.5.4.	 	The NDP must be faxed to Clayton Plasma Receiving within 1 working day of
notification of Post Donation Information resulting in product recalls or
seizure concerning units shipped to Talecris. Reference the Talecris fax number
on the NDP form.
	 
	 	7.5.5.	 	The NDP must be faxed to Clayton Plasma Receiving within a timely manner for
Post Donation Information (PDI) not resulting in a seizure or recall (example:
tattoo, body piercing, high risk). Reference the Talecris fax number on the NDP
form.

 

 

	 	 	 	 	 
	Talecris

	 	STANDARD OPERATING PROCEDURE
	 	SOP #: CS-000-BE-053
	BIOTHERAPEUTICS

	 	 	 	REVISION: 12
	 

	 	TITLE: Plasma Supplier Supplemental Directions
	 	PAGE 6 of 13

	 	7.5.6.	 	For any reason other than viral marker lookback, record reason as
“Other” status in Section 3 of the NDP form and provide a detailed
explanation. An example of “Other” unacceptable plasma is plasma from donors
with valid post-donation information that would make them unacceptable
donors; Public Health Notifications; plasma involved in plasma shipping
errors, etc. Complete information is needed by Talecris to evaluate the
status of plasma pools that contain units with any post-donation information
except lookback plasma units. If necessary, use an additional sheet of paper
identified by Center Code/NDDR and Donor Number.
	 
	 	7.5.7.	 	Enter date the reactive test result, or other information, was received by the
plasma center in Section 4 of the NDP form.
	 
	 	7.5.8.	 	Complete only one NDP per donor, even if the donor is reactive for more than
one test. Use the longest lookback period as defined in the Table of Actions.
	 
	 	7.5.9.	 	Within one working day of receipt of a NDP, Clayton will fax a partially
completed copy of the NDP, confirming receipt of NDP, to the fax number (plasma
center or corporate office) entered in Step 6 of the form. If the fax is not
received, contact Plasma Receiving, Talecris, Clayton (919-359-4444).
	 
	 	 	 	Clayton will only fax a completed dispositioned copy of the NDP for
notifications marked “Recall.” It may take several months for plasma
suppliers to receive the completed, dispositioned copy of the NDP from
Talecris due to the plasma inventory hold periods.
	 
	 	7.5.10.	 	In the event that a change has to be made to an original NDP that has already
been sent to Clayton Lookback, the plasma supplier must stamp or write Revision
and clearly indicate by circling the change(s) and/or addition(s) made that
differ from the data reported on the original NDP before re-sending to Clayton
Lookback. A date and initials must accompany these changes, additions, and/or
comments. Any alternative method for error correction to original NDP’s must be
pre-approved by Talecris (example: brackets).

	 	7.6.	 	Plasma Packaging

	 	7.6.1.	 	Talecris requires all U.S. source plasma to be collected and shipped in
approved bottles for receipt.

	 	a.	 	Remove all rubber bands or tape prior to placing
unfrozen plasma units in freezer.
	 
	 	b.	 	Store filled cases in a freezer operating at
-20°C or colder until time of shipment.
	 
	 	c.	 	The plasma case must be pre-approved, in writing,
by Talecris Manager of Technical Services or designated Talecris Plasma
Operations Account Managers with input from Talecris QO and Supply Chain
groups.
	 
	 	d.	 	The plasma case must have any softgoods labeling
information either crossed out or only the plasma case label visible.

 

 

	 	 	 	 	 
	Talecris

	 	STANDARD OPERATING PROCEDURE
	 	SOP #: CS-000-BE-053
	BIOTHERAPEUTICS

	 	 	 	REVISION: 12
	 

	 	TITLE: Plasma Supplier Supplemental Directions
	 	PAGE 7 of 13

	 	e.	 	Line the case with a polyethylene liner of at least 1.3 mil thickness
that has been inspected for tears prior to placing into the case. The
liner selected must permit closure of the filled case without bulging or
tearing. Do not use twist ties to close the liner.
	 
	 	f.	 	The maximum acceptable volume of Normal plasma to
be shipped to Talecris in a vendor batch number is 3,700 Liters.
	 
	 	g.	 	Targeted volume of plasma to be shipped to
Talecris in a vendor batch number is 1,840 Liters.
	 
	 	h.	 	Targeted minimum volume of plasma to be shipped
to Talecris in a vendor batch number is 90 liters. Talecris Plasma
Operations Account Manager must be notified for any vendor batch number
less than 90 liters prior to shipment.
	 
	 	i.	 	Plasma units with less than 200 mL are
unacceptable to Talecris.
	 
	 	j.	 	Plasma units from individual donors must not be
shipped to Talecris out of collection sequence.

	 	7.6.2.	 	Two plasma supplier employees must participate in packing plasma units into
the case, one employee performing the task and the other verifying the correct
units are being packed and the correct labels have been applied. Each
participating employee’s initials are required on the Plasma Packing List.

	 	a.	 	Alternatively, automated electronic verification
may be used; in which case
one person’s initials must appear on the Plasma Packing List verifying
correct packing and labeling.
	 
	 	b.	 	Only if a Plasma Center has one employee can
packing and manual
verification be performed and initialed by one person.

	 	7.6.3.	 	When using the Sigma Bar Code Printer System apply a vendor batch number
sticker and a SAP case number sticker on the plasma shipper label, in spaces
adjacent to each hand-written entry.
	 
	 	7.6.4.	 	Prior to use each day, verify the Sigma label printer/scanner against the
Daily Start up Label Set. Create all three donation labels from the Daily Start
up Label Set
scan menu, and compare to the sample labels provided on the menu. Document
results on a Daily Start up Scanner/Printer Test Record or equivalent. Deface
and discard test labels.

	 	a.	 	Alignment of the label stock should be monitored
throughout the day to ensure that the white spaces (quiet zones) on each
side of the barcode are no less
than 1/8.”

 

 

	 	 	 	 	 
	Talecris

	 	STANDARD OPERATING PROCEDURE
	 	SOP #: CS-000-BE-053
	BIOTHERAPEUTICS

	 	 	 	REVISION: 12
	 

	 	TITLE: Plasma Supplier Supplemental Directions
	 	PAGE 8 of 13

	 	7.7.	 	Storage Temperature Certification

	 	7.7.1.	 	Using the Packing List Summary (PLS) form, the plasma supplier will record the
temperature status of the plasma shipment while it has been in storage.
	 
	 	7.7.2.	 	There are three options for plasma temperature storage disposition:

	 	a.	 	The first option for temperature storage
certification is applicable if all storage temperature recordings for
associated plasma have been -20°C or colder.
	 
	 	b.	 	The second option for temperature storage
certification is applicable if only one temperature storage excursion
has occurred for associated plasma and it still meets the maximum
temperature requirements for Source Plasma in 21 CFR 640.76. Option 2
requires copies of all applicable temperature records (freezer graph(s),
freezer logs and any associated investigation and/or CAPA documents) to
be attached to Page 2 of the PLS forms.
	 
	 	c.	 	The third option for temperature storage
certification is applicable if all storage temperature recordings for
associated plasma meet the requirements for Source Plasma, Salvaged as
defined in 21 CFR 640.76. Option 3 also requires copies of all
applicable temperature records to be attached to Page 2 of the PLS
forms. Additionally, since pre-approval from Talecris is required for
shipment, the Request/Approval Form for Source Plasma, Salvaged must be
initiated and forwarded to the Talecris Account Manager. Full
instructions for shipment of Source Plasma, Salvaged is listed in
Section 7.8.

	 	7.8.	 	Source Plasma, Salvaged

	 	7.8.1.	 	Because Talecris is limited in the timeframe in which plasma must be processed
(greater than 60 days but less than 3 years from date of collection) and because
of the limited markets that will accept product manufactured from source plasma,
salvaged, receipt of this material is not desirable.
	 
	 	7.8.2.	 	Source Plasma, Salvaged is defined in 21 CFR 640.76.
	 
	 	7.8.3.	 	Prior to shipment of any Source Plasma, Salvaged, written approval must be
received from Talecris Plasma Operations Account Manager with Clayton QO Plasma
concurrence.

	 	a.	 	Complete Talecris Shipment Request/Approval Form
for Salvaged Plasma.
	 
	 	b.	 	Submit completed form with required documentation
to Talecris Account Manager for approval.

	 	7.8.4.	 	Each case of plasma, the Packing List Summary Sheet and Bill of Lading must be
clearly marked: “Source Plasma — Salvaged.”
	 
	 	7.8.5.	 	Source plasma, salvaged, is not used for products going to EU and, therefore,
cannot be labeled with German/EU plasma material numbers.

 

 

	 	 	 	 	 
	Talecris

	 	STANDARD OPERATING PROCEDURE
	 	SOP #: CS-000-BE-053
	BIOTHERAPEUTICS

	 	 	 	REVISION: 12
	 

	 	TITLE: Plasma Supplier Supplemental Directions
	 	PAGE 9 of 13

	 	7.8.6.	 	Talecris will not accept any salvaged hyperimmune plasma. If
hyperimmune plasma, other than Anti-D plasma, is re-classified as Source
Plasma Salvaged, it must be relabeled as Normal X plasma. Anti-D plasma may
not be re-labeled as Normal X plasma nor shipped as salvaged.
	 
	 	7.8.7.	 	A copy of the freezer temperature chart(s) and a report containing the
following information must accompany any shipment of source plasma, salvaged:

	 	a.	 	The vendor batch number
	 
	 	b.	 	Prior written Talecris approval to ship source
plasma, salvaged
	 
	 	c.	 	The maximum temperature reached by the freezer
	 
	 	d.	 	The time span during which the temperature was
warmer than -20°C
	 
	 	e.	 	The number of times the plasma was exposed to
temperatures warmer than -20°C during the entire freezing and storage
period of the product.
	 
	 	f.	 	The cause of the incident and corrective action
taken

	 	7.9.	 	Shipment Documentation Requirements

	 	7.9.1.	 	A documentation packet must accompany each shipment of plasma, and must
include the plasma packing list(s), the Packing List Summary Sheet(s), and the
Bill of Lading(s). This packet must be given to the driver of the Talecris
designated-carrier when plasma is shipped.

	 	a.	 	The plasma center address provided on the plasma
packing list(s), the Packing List Summary Sheet(s), and the Bill of
Lading(s) must match the address listed on the Form FDA 2830, Blood
Establishment Registration and Product Listing. The Form FDA 2830 is
updated annually and validated by FDA. Any and all changes in plasma
center address regardless of reason must be noted in the annual update
of the Form FDA 2830. The most current Form 2830 must be provided
immediately to the Talecris Plasma Operations Account Manager following
validation by FDA and receipt by plasma supplier. This applies to the
initial registration and each annual registration for every plasma
center.

	 	1.)	 	A letter from the corporate office of the plasma
supplier on company letterhead must be provided to the
appropriate Plasma Operations Account Manager immediately for
each address change. The letter must include the following
information:

	 	 	 	1.a) The reason for the address changes (e.g., Zip
code change, street extension, correction, etc.)
	 
	 	 	 	1.b) Verification that the plasma center has not
relocated.

 

 

	 	 	 	 	 
	Talecris

	 	STANDARD OPERATING PROCEDURE
	 	SOP #: CS-000-BE-053
	BIOTHERAPEUTICS

	 	 	 	REVISION: 12
	 

	 	TITLE: Plasma Supplier Supplemental Directions
	 	PAGE 10 of 13

	 	1.c)	 	 Commitment to include the change in the Form
FDA 2830 annual registration to FDA and provide the
validated form to the Talecris Plasma Operations
Account Manager immediately after receipt.

	 	b.	 	Any address changes which have not been
previously communicated to Talecris that are discovered by upon receipt
of plasma at the Clayton facility will be addressed with the plasma
supplier corporate office by the Plasma Operations Account Manager.
	 
	 	c.	 	The volume entries must be carried out to three
decimal places for all manual entries. It is permissible to carry out to
two decimal places when a document is system generated and the ending
zero is dropped.
	 
	 	d.	 	The plasma packing lists must be the original
documents or, if copies, stamped with “This is a true and accurate copy
of the original” or similar verbiage. Any copies must be signed and
dated by the responsible individual at the collection facility. If the
entire packing list is a copy, one stamp, initialed and dated is
adequate with total number of pages of PPL indicated at stamp site.

NOTE: If the entire packing list is a copy, one stamp, initialed and dated is adequate.

	 	7.9.2.	 	The plasma packing list and Packing List Summary Sheet information may be
alternatively sent to Talecris via electronic data interchange (EDI) with prior
written approval by Talecris. The same information is required.
	 
	 	7.9.3.	 	The plasma packing list must contain the following information:

	 	a.	 	Name, address, and Talecris assigned center code
of the collection facility or, minimally, the corporate office address
of the plasma supplier
	 
	 	b.	 	Name and address of each testing facility used
for all required tests
	 
	 	c.	 	Individual test results per plasma unit. Only
with prior written approval by Talecris QO Plasma may the supplier
certify that all Source Plasma units are negative by approved tests for
all required tests as detailed in the Talecris General Specification.
	 
	 	d.	 	A statement that all donors have tested negative
for syphilis as required by the Code of Federal Regulations. This
statement may be documented on the Packing List Summary form.
	 
	 	e.	 	Plasma material number
	 
	 	f.	 	Case numbers
	 
	 	g.	 	Unique bleed number/control number for each unit
	 
	 	h.	 	Unique donor number for each unit or unique
traceability system of units to donors

 

 

	 	 	 	 	 
	Talecris

	 	STANDARD OPERATING PROCEDURE
	 	SOP #: CS-000-BE-053
	BIOTHERAPEUTICS

	 	 	 	REVISION: 12
	 

	 	TITLE: Plasma Supplier Supplemental Directions
	 	PAGE 11 of 13

	 	i.	 	Plasma volume (mL) for each unit
	 
	 	j.	 	Total number of units in each case
	 
	 	k.	 	Total volume of plasma in each case
	 
	 	l.	 	Vendor batch number
	 
	 	m.	 	Initials and dates as required

	 	7.9.4.	 	The Packing List Summary must contain the following identifying information:

	 	a.	 	Plasma center name and address
	 
	 	b.	 	Talecris-assigned center code
	 
	 	c.	 	NDDR number
	 
	 	d.	 	Vendor batch number
	 
	 	e.	 	Talecris P.O. number
	 
	 	f.	 	Talecris plasma material number
	 
	 	g.	 	Number of shippers
	 
	 	h.	 	List of case numbers
	 
	 	i.	 	Liters
	 
	 	j.	 	Earliest bleed date
	 
	 	k.	 	Latest bleed date
	 
	 	l.	 	Certifications as appropriate

	 	7.9.5.	 	The Bill of Lading must contain the following information:

	 	a.	 	Carrier’s Name
	 
	 	b.	 	Center name and address
	 
	 	c.	 	Addressed to:
	 
	 	 	 	Talecris Biotherapeutics

c/o Nordic Warehouse

2400 Hodges Chapel Road

Benson, NC 27504
	 
	 	d.	 	Number of cases of plasma per vendor batch
	 
	 	e.	 	Plasma type
	 
	 	f.	 	Plasma material number
	 
	 	g.	 	Vendor batch number

NOTE: Each vendor batch must be on a separate line with required heading information.

 

 

	 	 	 	 	 
	Talecris

	 	STANDARD OPERATING PROCEDURE
	 	SOP #: CS-000-BE-053
	BIOTHERAPEUTICS

	 	 	 	REVISION: 12
	 

	 	TITLE: Plasma Supplier Supplemental Directions
	 	PAGE 12 of 13

	 	h.	 	Total cases shipped
	 
	 	i.	 	The statement “Maintain -20°C or colder in
transit”
	 
	 	j.	 	The statement “Load at -25°C or colder”
	 
	 	k.	 	Truck loading temperature
	 
	 	l.	 	Shipper’s signature
	 
	 	m.	 	Date and time (military or AM/PM designation).
Indicate time zone.
	 
	 	n.	 	Driver’s signature and date
	 
	 	o.	 	Trailer Number

	 	7.9.6.	 	Plasma cases to be shipped should not be removed from the freezer until the
transport truck is at the center and the trailer temperature has been checked
and found to be at -25°C or colder.
	 
	 	7.9.7.	 	The Sipper Label must, minimally, contain the following information:

	 	a.	 	“Ship from” and “ship to” addresses
	 
	 	b.	 	The complete vendor batch number
	 
	 	c.	 	The case number
	 
	 	d.	 	The product description
	 
	 	 	 	Reference Appendix G, Example Of Talecris Shipper Label, for preferred
format and other preferred label information.

	8.	 	DATA/INFORMATION MANAGEMENT, NOTIFICATION REQUIREMENTS

	 	8.1.	 	Detail all plasma shipment information on the accompanying plasma packing
lists, Packing List Summary (PLS) form, and Bill of Lading (BOL).
	 
	 	8.2.	 	Plasma suppliers must notify Talecris by the Notification for Destruction of
Plasma (NDP) form of any lookback, recall, or other situations in which plasma would be
deemed unacceptable to process.
	 
	 	8.3.	 	During the normal course of business operations, Talecris RTL preferred method
of test result data reporting will be an electronic method (Electronic Data Interface).
An alternate method of test result data reporting will be by printed, hard copy data
result sent by the most expedient method.
	 
	 	8.4.	 	Revision numbers or revised date listed in Section 9 to track individual
revisions to forms.

 

 

	 	 	 	 	 
	Talecris

	 	STANDARD OPERATING PROCEDURE
	 	SOP #: CS-000-BE-053
	BIOTHERAPEUTICS

	 	 	 	REVISION: 12
	 

	 	TITLE: Plasma Supplier Supplemental Directions
	 	PAGE 13 of 13

	9.	 	ATTACHMENTS

	 	9.1.	 	Appendix A, Example Of Notification For Destruction Of Plasma Form, 2 pages, Rev. 12
	 
	 	9.2.	 	Appendix B, Example Of Packing List Summary Form, 2 pages, Rev. 11
	 
	 	9.3.	 	Appendix C, Example Of Bill Of Lading, 1 page, Rev. 12
	 
	 	9.4.	 	Appendix D, Example Of Daily Startup Scanner/Printer Test Record, 1 page, Rev. 10
	 
	 	9.5.	 	Appendix E, Example Of Talecris Hemoglobin Comparator, 1 page, Revised 4/1/05, Rev. 11
	 
	 	9.6.	 	Appendix F, Example Of Talecris Shipment Request/Approval Form For Source
Plasma, Salvaged, 2 pages, Rev. 11
	 
	 	9.7.	 	Appendix G, Example Of Talecris Shipper Label, 1 page, Rev. 00

 

 

	 	 	 	 	 
	Talecris

	 	STANDARD OPERATING PROCEDURE
	 	SOP #: CS-000-BE-053
	BIOTHERAPEUTICS

	 	 	 	REVISION: 12
	 

	 	TITLE: Plasma Supplier Supplemental Directions
	 	PAGE 1 of 2
	 

	 	 	 	APPENDIX A

Example Of Notification For Destruction Of Plasma Form

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 
	 	NOTIFICATION FOR DESTRUCTION OF PLASMA	 	 	CS-000-BE-053, NDP Form; Revision 12, March 2006	 
	 	 	 	 	 	 	 	 	 	 	(Supercedes CS-000-AR-107, NDP Form; Revision 00)	 
	 	 	 	 	 	 	 	 	 	 	Page 1 of ___	 
	 	 	 	 	 	 
	 	This side to be completed by plasma supplier:	 	 	 	This side to be completed by Talecris Biotherapeutics, Clayton:	 
	 	 	 	 	 	 
	 	1.

	 	Plasma Supplier	 	 	 	 	 	 	 	 	 	 
	 	 

	 	Reference # (optional):	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	2.

	 	Center Code:
	 	NDDR #:
	 	Donor #
	 	 	 	1.	 	 	Record receipt of fax from plasma supplier and assign log number. Confirm receipt of
NDP form by completing this section and faxing back to the plasma supplier:	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	Receipt Date:                      Time:                      Log #                      Initials:                     	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	  (Next line for Talecris to be filled in only after confirmation of successful fax transmittal)	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	          Confirmation fax (within 1 working day):	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	          Date:
                    
Time:
                     Initials:                     	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 
	 	3.

	 	Center name
and address:
	 	 	 	 	 	 	 	 	Entries 2 — 5 For Talecris Use Only	 
	 	 	 	 	 	 	 	 	 	 
	 	 

	 	 	 	 	 	 	 	 	 	2.	 	 	Lookback Coordinator:	 
	 	 	 	 	 	 	 	 	 	 	 	Complete “Disposition Code” column for all units.	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 

	 	(Circle as
appropriate)
	 	 	 	 	 	 	 	 	Date: ______ Time: _______ Initials (2) ________/_____	 
	 	4.

	 	Lookback for: HBsAg anti-HCV
anti-HIV 1/2
HIV-1 Ag HCV
by NAT
HIV-1 by NAT
HBV by NAT “Other”
(explain below)	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 

	 	Date test
result or
other
information
received:	 	 	 	 	 	 	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Collection

	 	 	Control
	 	 	Plasma Item or
	 	 	Ship Doc #
	 	 	Case Number
	 	 	Disp.
	 	 	 	3.	 	 	Disposition Codes	 
	 	Date

	 	 	Number
	 	 	Material Number
	 	 	or Vendor
	 	 	 	 	 	Code
	 	 	 	 	 	 	#1 Pooled prior to notification	 
	 	 

	 	 	 	 	 	 	 	 	Batch #
	 	 	 	 	 	 	 	 	 	 	 	 	#2 Unit received; to be destroyed	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 

	 	 	 	 	 	Reactive Unit for
	 	 	N/A
	 	 	N/A
	 	 	N/A
	 	 	 	 	 	 	#3 Unit in transit/off-site storage; to be destroyed	 
	 	 

	 	 	 	 	 	Viral or by NAT
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#4 Unit shipped to contract fractionator	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#6 Unit shipped back to plasma supplier	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#7 Unit used for research purposes	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#8 Unit removed for reason other
than NDP	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Explanation for “Other”:	 	Collection date of last negative Unit:	 	 	 	4.	 	 	Contract Fractionation Section:	 	 	 
	 	 

	 	 	 	 	 	 	 	 	 	 	Contract fractionator notified by fax (Code #4):
	 	Date/Initials:                     	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	5.

	 	Information verified:
	 	 	 	 	 	 	 	 	Fractionator’s acknowledgement of fax received:
	 	Date/Initials:                     	 
	 	 	 	Date:                      Initials (2)                      /                     	 	 	 	 	 	 	Fractionator’s disposition report received:	 	Date/Initials:                     	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	Phone Clayton of intent
to fax (919) 359-4444 Initials:                     	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 
	 	6.

	 	Plasma Supplier fax:
	 	 	 	 	 	5.	 	 	Completion and Final Review of NDP:	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	Reference attached “Work Complete” print screen from the

NDP Database for the following:	 
	 	 	 	 	 	 	 	 	 	 	 	 	- Pool Number	 
	 	7.	 	Fax this form to Clayton: (919) 359-4428	 	 	 	 	 	 	- Unit Removed/Destruction Date	 
	 	 	 	 	 	 	 	 	 	 	 	 	Lookback Coordinator: Attach a “Work Complete”
Print Screen to this NDP form. Verify
each unit is reconciled and matches disposition
on Work Complete Printout.	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Date faxed:                      Initials:                     	 	 	 	 	 	 	 	 	Date:                      Time:                      Initials                     	 
	 	 	 	 	 	 	 	 	 	 	 	 	Lookback Coordinator “Work Complete” approval: Date/Initials:                     	 
	 	 	 	 	 	 	 	 	 	 	 	 	QO Plasma
‘Close’ review and approval: Date/Initials:                     	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 

 

 

	 	 	 	 	 
	Talecris

	 	STANDARD OPERATING PROCEDURE
	 	SOP #: CS-000-BE-053
	BIOTHERAPEUTICS

	 	 	 	 
	 

	 	TITLE: Plasma Supplier Supplemental Directions
	 	PAGE 2 of 2
	 

	 	 	 	APPENDIX A

Example Of Notification For Destruction Of Plasma Form

	 	 	 
	NOTIFICATION FOR DESTRUCTION OF PLASMA
	 	CS-000-BE-053, NDP Form; Revision 12, March 2006  

(Supercedes CS-000-AR-107, NDP Form; Revision 00)  

Page ___ of ___  
	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 
	This side to be
completed by plasma supplier:	 	 	This side to be completed by Talecris Biotherapeutics, Clayton:	 
	 	 	 	 	 	 	 	 	 	 	 	 	 
	Plasma Supplier Reference # (optional):  	 	 	Log #:       
             
              
              
              
               
              
          	 
	 	 	 	 	 	 	 	 	 	 	 	 	 
	Center Code:

	 	 	NDDR #:
	 	 	Donor #:	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Collection 

Date

	 	 	Control Number
	 	 	Plasma Item or

Material Number
	 	 	Ship Doc #

or Vendor Batch
#
	 	 	Case Number
	 	 	Disp. Code	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Disposition Codes
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#1 Pooled prior to notification
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#2 Unit received; to be destroyed
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#3 Unit in transit/off-site storage; to be destroyed
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#4 Unit shipped to contract fractionator
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#6 Unit shipped back to plasma supplier
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	# 7 Unit used for research purposes
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#8 Unit removed for reason other than NDP
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

 

 

	 	 	 	 	 
	Talecris
	 	STANDARD OPERATING PROCEDURE	 	SOP #: CS-000-BE-053
	          BIOTHERAPEUTICS
	 	 	 	REVISION: 11
	 
	 	TITLE:   Plasma Supplier Supplemental Directions	 	PAGE 1 of 2
	 
	 	 	 	APPENDIX B

Example Of Packing List Summary Form

CS-000-BE-053, PLS Form: Revision 11, March, 2006

(Supercedes: CS-000-AR-107, PLS Form: Revision 00)

Packing List Summary — Page 1

Center Name & Address:

	 	 	 
	Center Code:
	 	 
	 

	 	 
	 
	 	 
	NDDR #:
	 	 
	 

	 	 
	 
	 	 
	Vendor Batch #
	 	 
	 

	 	 
	 
	 	 
	Talecris P.O. #:
	 	 
	 

	 	 

	 	 	 	 	 	 	 	 	 
	Plasma Material	 	 	 	 	 	 	 	 
	Number	 	# of Units	 	# of Shippers	 	Case Numbers	 	Liters
	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 

			
	This shipment:	 	Earliest Bleed Date:                     

Latest Bleed Date:                     

This is to certify that:

	•	 	All plasma units in this shipment are negative/non-reactive for the following tests:
	 
	 	 	HBsAg, Anti-HCV, Anti-HlV-1/2, HCV / HIV-1 / HBV by NAT, and ALT values less than or equal to 2X the upper limit of normal.
	 
	•	 	Applicant Donor units in this shipment have been qualified by the receipt of acceptable test results obtained on a
second unit within six months of the first unit.
	 
	•	 	Applicant Donor units in this shipment, with the exception of Anti-D specialty plasma donors, are negative for Anti-D.
	 
	•	 	Entire Anti-D shipment has an Anti-C titer of less than or equal to 1:8.

	 	•	 	Donors participating in an Anti-D stimulation program have not contributed to this
shipment unless it is an Anti-D plasma shipment.

	•	 	All donors have tested negative for syphilis as required by the Code of Federal Regulations.
	 
	•	 	Hyperimmune Anti-D, Rabies, Tetanus, and Hepatitis plasma have been pre-qualified by the Raleigh Test Lab.
	 
	•	 	All plasma units in this shipment have been collected and stored in compliance with all regulatory requirements and
Talecris specifications.

Check one:

	o	 	The plasma in this shipment was stored at -20°C or colder, and is designated Source Plasma.
	 
	o	 	The plasma in this shipment was stored at -20°C or colder, with an allowable temperature excursion (See
PLS page 2 attached along with required temperature records), and is designated Source Plasma.
	 
	o	 	The plasma in this shipment is designated Source Plasma, Salvaged (temperature records
required).

Total number of storage temperature excursions warmer than -20oC from
earliest bleed date to shipping date:

                                        

(if answer is other than zero complete PLS page 2 and attached to this form.)

PLASMA APPROVED FOR RELEASE:

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	/
	 	 	 	 	 	 	 	/	 	 
	 

	 	 	 	 
	 	 	 	 
	 	 	 	 
	Quality

	 	 	 	Date
	 	 	 	Management
	 	 	 	Date

 

 

	 	 	 	 	 
	Talecris
	 	STANDARD OPERATING PROCEDURE	 	SOP #: CS-000-BE-053
	          BIOTHERAPEUTICS
	 	 	 	REVISION: 11
	 
	 	TITLE:   Plasma Supplier Supplemental Directions	 	PAGE 2 of 2
	 
	 	 	 	APPENDIX B

Example Of Packing List Summary Form

CS-000-BE-053, PLS Form: Page 2 Revision 11, March, 2005

Packing List Summary — Page 2

	 	 	 	 	 
	Center Code:
	 	 	 	 
	 

	 	 

	 	 
	NDDR #:
	 	 	 	 
	 

	 	 

	 	 
	Vendor Batch #:
	 	 	 	 
	 

	 	 

	 	 
	Material Number:
	 	 	 	 
	 

	 	 

	 	 

Attach copies of temperature records (freezer graph(s), freezer logs and any associated
investigation and/or
CAPA documents) related to the excursion(s) described below:

	 	 	 	 	 	 	 
	 	 	Maximum	 	Duration of	 	 
	Date of	 	Temperature	 	Temperature	 	 
	Excursion(s)	 	Reached	 	Excursion(s)	 	Reason for Excursion(s)
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 

			
	Note:	 	If temperature excursions warrant plasma to be
classified as “salvaged”, reference Talecris Plasma
Supplier Supplemental Directions 7.8, requiring
pre-approval from Talecris before shipment.

Signatures and Date

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	/
	 	 	 	 	 	 	 	/	 	 
	 

	 	 	 	 
	 	 	 	 
	 	 	 	 
	Management

	 	 	 	Date
	 	 	 	Quality
	 	 	 	Date

 

 

	 	 	 	 	 
	Talecris
	 	STANDARD OPERATING PROCEDURE	 	SOP #: CS-000-BE-053
	          BIOTHERAPEUTICS
	 	 	 	REVISION: 12
	 
	 	TITLE:   Plasma Supplier Supplemental Directions	 	PAGE 1 of 1
	 
	 	 	 	APPENDIX C

Example Of Bill Of Lading

UNIFORM BILL OF LADING

			
	           TO:	 	TALECRIS

c/o Nordic Warehouse

2400 Hodges Chapel Road

Benson, NC 27504

CARRIER NAME                                         

			
	          FROM:	 	Plasma Center

1234 Main Street

Any Where, USA 11111

	 	 	 	 	 	 	 
	 	 	 	 	Plasma Type	 	 
	Vendor Batch #	 	# Of Cases	 	(NX, TX, CX, etc)	 	SAP Material #
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 

                               Total Cases Shipped

	 	 	 	 	 
	MAINTAIN -20oC OR COLDER IN TRANSIT
	 	 	 	LOAD AT -25oC OR COLDER

SHIPPER SECTION:

	 	 	 	 	 	 	 	 	 
	 

	 	 
	 	 
	 	 
	 	 
	 

	 	Truck Temperature
	 	Shipper’s Signature
	 	Date
	 	Time (military)

E C M P

(Circle Time Zone)

TRUCK DRIVER SECTION:

	 	 	 	 	 	 	 
	 

	 	 

          Driver’s Signature
	 	 

Date
	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	 

	 	          Trailer #	 	 	 	 

 

 

	 	 	 	 	 
	Talecris
	 	STANDARD OPERATING PROCEDURE	 	SOP #: CS-000-BE-053
	          BIOTHERAPEUTICS
	 	 	 	REVISION: 10
	 
	 	TITLE:   Plasma Supplier Supplemental Directions	 	PAGE 1 of 1
	 
	 	 	 	APPENDIX D

Example Of Daily Startup Scanner/Printer Test Record

	 	 	 	 	 	 	 
	 	 	Printed Labels	 	 	 	 
	 	 	Same As Sample?	 	COMMENTS	 	 
	Date	 	Yes     No	 	(Explain any NO responses and corrective action taken)	 	Initials
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 
	 	 	 	 	 	 	 
	 
	 	 
	 	 
	 	 

 

 

	 	 	 	 	 
	Talecris
	 	STANDARD OPERATING PROCEDURE	 	SOP #: CS-000-BE-053
	          BIOTHERAPEUTICS
	 	 	 	REVISION: 11
	 
	 	TITLE:   Plasma Supplier Supplemental Directions	 	PAGE 1 of 1
	 
	 	 	 	APPENDIX E

Example Of Talecris Hemoglobin Comparator

NOTE: Example shown in black and white, color version distributed to plasma suppliers.

 

 

	 	 	 	 	 
	Talecris
	 	STANDARD OPERATING PROCEDURE	 	SOP #: CS-000-BE-053
	          BIOTHERAPEUTICS
	 	 	 	REVISION: 11
	 
	 	TITLE:   Plasma Supplier Supplemental Directions	 	PAGE 1 of 2
	 
	 	 	 	APPENDIX F

Example Of Talecris Shipment Request/Approval Form For Source Plasma, Salvaged

Revision 11

Talecris Shipment Request/Approval Form For Source Plasma, Salvaged

Center Management must complete this form and submit to Talecris Account Manager minimally
one week prior to the proposed shipping date with applicable documentation for salvaged plasma
intended for approval and subsequent shipment to Talecris 

	 	 	 	 	 	 	 
	Plasma Center Name

	 	 	 	Talecris Center Code	 	 
	 

	 	 
	 	 	 	 
	 
	 	 	 	 	 	 
	Plasma Material Number
	 	 	 	 	 	 
	 	 	 

	Bill of Lading Number(s)
	 	 	 	 	 	 
	 	 	 

	Vendor Batch Number(s)
	 	 	 	 	 	 
	 	 	 

Section 1 — To be completed and submitted for approval to Talecris Account Manager

	 	 	 	 	 
	Plasma Center Information/Action	 	Info/Action	 	Initials/Date
	Number of units of Source Plasma, Salvaged
	 	 	 	 
	 
	 	 	 	 
	Number of cases of Source Plasma, Salvaged
	 	 	 	 
	 
	 	 	 	 
	Earliest collection date of Source Plasma, Salvaged
	 	 	 	 
	 
	 	 	 	 
	Latest collection date of Source Plasma, Salvaged
	 	 	 	 
	 
	 	 	 	 
	Total time which the temperature was warmer than -20°C (recorded in hours)
	 	 	 	 
	 
	 	 	 	 
	Warmest temperature reached by freezer
	 	 	 	 
	 
	 	 	 	 
	Number of times plasma was exposed to temperatures warmer than -20°C
during the entire freezing and storage period of the product.
	 	 	 	 
	 
	 	 	 	 
	Incident Report detailing the cause of the incident and CAPA taken (circle
yes or no)

	 	Y / N	 	 
	 
	 	 	 	 
	All cases marked — “Source Plasma — Salvaged” (circle yes or no)

	 	Y / N	 	 
	 
	 	 	 	 
	BOL marked — “Source Plasma — Salvaged” (circle yes or no)

	 	Y / N	 	 
	 
	 	 	 	 
	Packing List Summary marked — “Source Plasma — Salvaged” (circle yes or no)

	 	Y / N	 	 
	 
	 	 	 	 
	Plasma re-classified/relabeled as Normal plasma if originally hyperimmune 

plasma (Anti-D plasma cannot be relabeled as Normal plasma nor shipped as 

salvaged plasma) (circle yes, no or N/A)

	 	Y / N /

N/A	 	 
	 
	 	 	 	 
	Freezer temperature charts included with submission of Talecris Shipment
Request/Approval Form of Source Plasma, Salvaged accounting for the date
plasma was placed in freezer until date of this request (include period
temperature of freezer was warmer than -20°C) (circle yes or no)

	 	Y / N	 	 

 

 

	 	 	 	 	 
	Talecris
	 	STANDARD OPERATING PROCEDURE	 	SOP #: CS-000-BE-053
	          BIOTHERAPEUTICS
	 	 	 	REVISION: 11
	 
	 	TITLE:   Plasma Supplier Supplemental Directions	 	PAGE 2 of 2
	 
	 	 	 	APPENDIX F

Example Of Talecris Shipment Request/Approval Form For Source Plasma, Salvaged

Section 2 — To be completed by Talecris Account Manager:

	 	 	 	 	 
	Talecris Account Manager reviewed supplier’s Incident Report and
found complete and acceptable

	 	Y / N
	 	 

Section 3 — To be completed at time of shipment: [ ] N/A if Section 2 is answered “NO”.

	 	 	 	 	 
	Number of times plasma was exposed to temperature warmer than
-20°C during the entire freezing and storage period
	 	 	 	 
	 
	 	 	 	 
	Freezer temperature charts included in shipping document packet 

accounting for the entire storage period (circle yes or no)

	 	Y / N
	 	 

	 	 	 	 	 
	Plasma Center Manager

	 	 	 	Signature/Date
	 

	 	 	 	 

	 	 	 	 	 
	Disposition of Request:

	 	 	 	(Circle One)

	 	 	 	 	 	 	 	 	 
	 

	 	/
	 	 	 	Approve
	 	Reject
	 

	 	 	 	 	 	 	 	 
	Talecris Account Manager

	 	 	 	/ Date	 	 	 	 

	 	 	 	 	 	 	 	 	 
	 

	 	/
	 	 	 	Approve
	 	Reject
	 

	 	 	 	 	 	 	 	 
	Talecris Clayton Quality Operations Manager

	 	 	 	/ Date	 	 	 	 

 

 

	 	 	 	 	 
	Talecris

BIOTHERAPEUTIC	 	STANDARD OPERATING PROCEDURE
	 	SOP #: CS-000-BE-053

REVISION: 00
	 

	 	TITLE: Plasma Supplier Supplemental Directions
	 	PAGE 1 of 1

APPENDIX G

Example Of Talecris Shipper Label

SHIP — TO:

TALECRIS BIOTHERAPEUTICS

C/O NORDIC WAREHOUSE 2400 HODGES CHAPEL RD

BENSON, NC 27504

RETURN — TO:

OHIO BLOOD PLASMA, INC.

1116 MAIN STREET

CINCINNATI, OH 45202

U.S. LICENSE NO. 484

MATERIAL #: [BARCODE]

                        08634958

NORMAL, EU APPROVED (BOTTLES)

VENDOR BATCH

                              [BARCODE]

                    069424006003

CASE #: [BARCODE]

                240054198

 

	 	 	 	 	 
	Talecris
	 	 	 	 
	BIOTHERAPEUTICS	FINAL CONTROLLED DOCUMENT ROUTING FORM (REV 06)	Page 1 of 1

o NEW            þ REVISED            o TEMPORARY            o ALL
LOTS            o
 LOT SPECIFIC            o AS REQUESTED

	 	 	 	 	 	 	 
	Document Type:

	 	þ SOP
	 	o BPR
	 	o Other (Specify)
	 
	 	 	 	 	 	 
	Document #

	 	CS-000-BE-053
	 	Rev # 12
	 	Prev. Doc. # N/A
	 
	 	 	 	 	 	 
	Document Title:	 	Plasma Supplier Supplemental Directions
	 
	 	 	 	 	 	 
	Authored By:

	 	Amy Durham
	 	 	 	o Author Check/Sign/Date for Training Credit
	 
	 	 	 	 	 	 
	Owner’s Dept. Name:	 	QO Plasma / Zone 1	 	Date Requested: 02/20/2006
	 
	 	 	 	 	 	 
	Document Owner:

	 	Amy Durham	 	 	 	 
	 
	 	 	 	 	 	 
	EFFECTIVE DATE

	 	MAR 31 2006
	 	 	 	FINAL DATE USED

Type of Change:    
       o D   
        o C  
         o B
          þ
A        
   Change Control #: 2006052        
    o N/A

	 	 	 	 	 	 	 	 	 	 	 
	Document processed by:	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Signature:

	 	/s/ Christy Pychinka
	 	Print Name:
	 	Christy Pychinka
	 	Date:
	 	2/21/06
	 
	 	 	 	 	 	 	 	 	 	 
	Document reviewed in
accordance with current requirements:
 o Check for Training
Credit

	 
	 	 	 	 	 	 	 	 	 	 
	Signature:

	 	/s/ Susan Dixon
	 	Print Name:
	 	Susan Dixon
	 	Date:
	 	2/21/06

WRITE A PARAGRAPH IN THE SPACE BELOW, SUMMARIZING THE PRIMARY REASON(S) FOR THIS REVISION

CCR 2006052

	1.	 	Sections 3.4. and 7.6.1.c. — Indicate that the functions usually performed by the Talecris
Plasma Operations Technical Services Manager may be performed by the Talecris Plasma
Operations Account Mangers in the absence of the Technical Services Manager. Clarification by
Plasma Operations of technical services functions performed in the absence of this position.

	2.	 	Add new Section 7.5.2. and re-number remaining sections — Add section defining lookback and
post donation information (PDI) notification requirements for listed plasma bleeds collected
under prior NDDR and center code references. Clarify what NDDR and center code is required on
the notification form for bleeds collected under prior ownership or previous NDDR number.

	3.	 	Add new Section 7.6.1.d. and re-number remaining sections — Added for clarity of shipper
information.

	4.	 	Section 7.7.2.b. and Appendix B — List specific documentation that is required for review if
there is more than 1 temperature excursion. Clarification and consistency of needed
documentation to review in cases of more than one storage temperature excursion (>20C).

	5.	 	Section 7.9.5.C. and Appendix C — Correct Benson address. It should be 2400 Hodges Chapel
Road.

6. Section 7.9.5.1. Add or AM/PM designation for clarification.

	7.	 	New Section 7.9.7. — List minimum information that is required on the plasma shipper label.
Added for clarification and consistency for shipper label information.

8. Appendix A — Change Bayer reference to Talecris and update revision number.

	9.	 	New Appendix G — Example of shipper label. As with NDP and the packing list summary form,
include an example template for suppliers to reference for consistency.

	 	 	 	 	 
	As Document Owner, I state that the proposed changes and the entire document are consistent with all systems, documents, and 

current
requirements. þ  Check for Training
Credit

	 
	 	 	 	 
	Signature:           /s/ Amy W. Durham

	 	Print Name:   Amy W. Durham
	 	Date:   2/28/06
	 
	 	 	 	 
	As Quality Approver, I have found the proposed changes and the entire document to be compliant with cGMPs and appropriate for
the intended purpose of producing safe, pure and effective products.
o  Check for Training
Credit

	 
	 	 	 	 
	Signature:           /s/ John W. Parrish

	 	Print Name:    John W. Parrish
	 	Date:   2/28/2006

 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 
	 	NOTIFICATION FOR DESTRUCTION OF PLASMA	 	 	CS-000-BE-053,
NDP Form: Revision 12 March 2006	 
	 	 	 	 	 	 	 	 	 	 	(Supercedes
CS-000-AR-107, NDP Form: Revision 00)	 
	 	 	 	 	 	 	 	 	 	 	Page 1 of
___

	 
	 	 	 	 	 	 
	 	This side to be completed by plasma supplier:	 	 	 	This side to be completed by Talecris Biotherapeutics, Clayton:	 
	 	 	 	 	 	 
	 	1.

	 	Plasma Supplier	 	 	 	 	 	 	 	 	 	 
	 	 

	 	Reference # (optional):	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	2.

	 	Center Code:
	 	NDDR #:
	 	Donor #
	 	 	 	1.	 	 	Record receipt of fax from plasma supplier and assign log number. Confirm receipt of
NDP form by completing this section and faxing back to the plasma supplier:	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	Receipt Date:                      Time:                      Log #                      Initials:        
             	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	(Next line for Talecris to be filled in only after confirmation of successful fax transmittal)	 
	 	 	 	 	 	 
	 	3.

	 	Center name
and address:
	 	 	 	 	 	 	 	 	          Confirmation fax (within 1 working day):	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	          Date:

                     Time:

                     Initials:
                    	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 
	 	 	 	 	 	 	 	 	Entries 2 — 5 For Talecris Use Only	 
	 	 	 	 	 	 	 	 	 	 
	 	 

	 	 	 	 	 	 	 	 	 	2.	 	 	Lookback Coordinator:	 
	 	 	 	 	 	 	 	 	 	 	 	Complete “Disposition Code” column for all units.	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 

	 	(Circle as
appropriate)
	 	 	 	 	 	 	 	 	Date: ______ Time: _______ Initials (2) ________/_____	 
	 	4.

	 	Lookback for: HBsAg anti-HCV
anti-HIV1/2
HIV-1Ag HCV
by NAT
HIV-1 by NAT
HBV by NAT “Other”
(explain below)	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 

	 	Date test
result or
other
information
received: ______________________	 	 	 	 	 	 	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Collection

	 	 	Control
	 	 	Plasma Item or
	 	 	Ship Doc #
	 	 	Case Number
	 	 	 	Disp.  	 	3.	Disposition Codes	 
	 	Date

	 	 	Number
	 	 	Material Number
	 	 	or Vendor Batch #
	 	 	 	 	 	 	Code  	 	 	#1 Pooled prior to notification	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#2 Unit received; to be destroyed	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 

	 	 	 	 	 	Reactive Unit for
	 	 	N/A
	 	 	N/A
	 	 	 	N/A  	 	 	#3 Unit in transit/off-site storage; to be destroyed	 
	 	 

	 	 	 	 	 	Viral or by NAT
	 	 	 	 	 	 	 	 	 	 	 	 	#4 Unit shipped to contract fractionator	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#6 Unit shipped back to plasma supplier	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#7 Unit used for research purposes	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#8 Unit removed for reason other
than NDP	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Explanation for “Other”:	 	Collection date of last negative Unit:	 	 	 	4.	 	 	Contract Fractionation Section:	 	 	 
	 	 

	 	 	 	 	 	 	 	 	 	 	Contract fractionator notified by fax (Code #4):
	 	Date/Initials:                     	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	5.

	 	Information verified:
	 	 	 	 	 	 	 	 	Fractionator’s acknowledgement of fax received:
	 	Date/Initials:                     	 
	 	 	 	Date:                      Initials (2)                      /                     	 	 	 	 	 	 	Fractionator’s disposition report received:	 	Date/Initials:                     	 
	 	 	 	Phone Clayton of intent to fax (919) 359-4444 Initials:                    	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 
	 	6.

	 	Plasma Supplier fax:
	 	 	 	 	 	5.	 	 	Completion and Final Review of NDP:	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	Reference attached
‘Work Complete’ print screen from the
NDP Database for the following:	 
	 	 	 	 	 	 	 	 	 	 	 	 	- Pool Number	 
	 	7.	 	Fax this form to Clayton: (919) 359-4428	 	 	 	 	 	 	- Unit Removed/Destruction Date	 
	 	 	 	 	 	 	 	 	 	 	 	 	Lookback Coordinator:
Attach a ‘Work Complete’
Print Screen to this NDP form. Verify
each unit is reconciled and matches disposition
on Work Complete Printout.	 
	 	Date faxed:                      Initials:                     	 	 	 	 	 	 	 	 	Date:                      Time:                      Initials                     	 
	 	 	 	 	 	 	 	 	 	 	 	 	Lookback Coordinator
‘Work Complete’ approval: Date/Initials:                     	 
	 	 	 	 	 	 	 	 	 	 	 	 	QO Plasma
‘Close’ review and approval: Date/Initials:                     	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 

 

 

			
	NOTIFICATION FOR DESTRUCTION OF PLASMA
	 	CS-000-BE-053, NDP Form: Revision 12, March 2006   

(Supercedes CS-000-AR-107, NDP Form: Revision 00)   

Page ___ of ___   
	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	This side to be completed by plasma supplier  	 	 	This side to be completed by Talecris Biotherapeutics, Clayton:
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Plasma Supplier Reference # (optional):  	 	 	 	Log #:                                                                      
           
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	  Center Code:

	 	  NDDR #:
	 	 	 	  Donor #:	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Collection

Date

	 	 	Control
Number
	 	 	Plasma Item or

Material Number
	 	 	Ship Doc #

or Vendor Batch #
	 	 	Case Number
	 	 	Disp. Code	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Disposition Codes	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#1 Pooled prior to notification	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#2 Unit received; to be destroyed	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#3 Unit in transit/off-site storage; to be destroyed	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#4 Unit shipped to contract fractionator	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#6 Unit shipped back to plasma supplier	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	# 7 Unit used for research purposes	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	#8 Unit removed for reason other than NDP	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

 

 

CS-000-BE-053, PLS Form: Revision 11, March, 2006

(Supercedes: CS-000-AR-107, PLS Form: Revision 00)

Packing List Summary — Page 1

	 	 	 	 	 	 
	 	Center Name & Address:

	 	 	Center Code:                                                             

NDDR #:                                                             

Vendor Batch:                                                             

Talecris P.O. #:                                                             	 
	 	 

	 	 	 	 	 	 	 	 	 
	Plasma Material	 	 	 	 	 	 	 	 
	Number	 	# of Units	 	# of Shippers	 	Case Numbers	 	Liters
	 

	 	 
	 	 
	 	                                        
	 	 
	 

	 	 
	 	 
	 	                                        
	 	 
	 

	 	 
	 	 
	 	                                        
	 	 
	 

	 	 
	 	 
	 	                                        
	 	 

			
	This Shipment:	 	Earliest Bleed Date:                                                             

Latest Bleed Date:                                                             

This is to certify that:

	•	 	All plasma units in this shipment are negative/non-reactive for the following tests:
HBsAg, Anti-HCV, Anti-HlV-1/2, HCV / HIV-1 / HBV by NAT, and ALT values less than or equal to 2X the upper limit of normal.
	 
	•	 	Applicant Donor units in this shipment have been qualified by the receipt of acceptable test results obtained on a
second unit within six months of the first unit.
	 
	•	 	Applicant Donor units in this shipment, with the exception of Anti-D specialty plasma donors, are negative for Anti-D.
	 
	•	 	Entire Anti-D shipment has an Anti-C titer of less than or equal to 1:8.

• Donors participating in an Anti-D stimulation program have not contributed to this
shipment unless it is an Anti-D plasma shipment.

	•	 	All donors have tested negative for syphilis as required by the Code of Federal Regulations.
	 
	•	 	Hyperimmune Anti-D, Rabies, Tetanus, and Hepatitis plasma have been pre-qualified by the Raleigh Test Lab.
	 
	•	 	All plasma units in this shipment have been collected and stored in compliance with all regulatory requirements and
Talecris specifications.

Check one:

	o	 	The plasma in this shipment was stored at -20°C or colder, and is designated Source Plasma.
	 
	o	 	The plasma in this shipment was stored at -20°C or colder, with an allowable temperature
excursion (See PLS page 2 attached along with required temperature records), and is designated Source Plasma.
	 
	o	 	The plasma in this shipment is designated Source Plasma, Salvaged (temperature records
required).

	 	 	 	 	 	 
	 	Total number of storage temperature excursions warmer than -20oC from
earliest bleed date to shipping date:

                                        

(If answer is other than zero complete PLS page 2 and attached to this form.)

	 	 	 	 
	 	 

PLASMA APPROVED FOR RELEASE:

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	/
	 	 	 	 	 	 	 	/	 	 
	 

	 	 	 	 
	 	 	 	 
	 	 	 	 
	Quality

	 	 	 	Date
	 	 	 	Management
	 	 	 	Date

 

 

CS-000-BE-053, PLS Form: Page 2 Revision 11, March, 2006

Packing List Summary — Page 2

Center Code:                                                             

NDDR#:                                                             

Vendor Batch #:                                                             

Material Number:                                                             

Attach copies of temperature records (freezer graph(s), freezer logs and any associated
investigation and/or CAPA documents) related to the excursion(s) described below:

	 	 	 	 	 	 	 
	 	 	Maximum	 	Duration of	 	 
	Date of	 	Temperature	 	Temperature	 	 
	Excursion(s)	 	Reached	 	Excursion(s)	 	Reason for Excursion(s)
	                    
	 	                    	 	                    	 	                    
	                    
	 	                    	 	                    	 	                    
	                    
	 	                    	 	                    	 	                    
	                    
	 	                    	 	                    	 	                    
	                    
	 	                    	 	                    	 	                    

			
	Note:	 	If temperature excursions warrant plasma to be
classified as “salvaged”, reference Talecris Plasma
Supplier Supplemental Directions 7.8, requiring
pre-approval from Talecris before shipment.

Signatures and Date

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	/
	 	 	 	 	 	 	 	/	 	 
	 

	 	 	 	 
	 	 	 	 
	 	 	 	 
	Management

	 	 	 	Date
	 	 	 	Quality
	 	 	 	Date

 

 

Revision 11

Talecris Shipment Request/Approval Form For Source Plasma, Salvaged

Center Management must complete this form and submit to Talecris Account Manager minimally one
week prior to the proposed shipping date with applicable documentation for salvaged plasma intended
for approval and subsequent shipment to Talecris

	 	 	 	 	 	 	 
	 

	 	 	 	Talecris Center	 	 
	Plasma Center Name

	 	 	 	Code	 	 
	 

	 	 
	 	 	 	 
	Plasma Material Number
	 	 	 	 	 	 
	 	 	 
	Bill of Lading Number(s)
	 	 	 	 	 	 
	 	 	 
	Vendor Batch Number(s)
	 	 	 	 	 	 
	 	 	 
	 
	 	 	 	 	 	 
	 	 	 

Section 1 — To be completed and submitted for approval to Talecris Account Manager

	 	 	 	 	 
	 	 	Info/Action	 	Initials/Date
	Plasma Center Information/Action
	 	 	 	 
	Number of units of Source Plasma, Salvaged
	 	 	 	 
	 
	 	 	 	 
	Number of cases of Source Plasma, Salvaged
	 	 	 	 
	 
	 	 	 	 
	Earliest collection date of Source Plasma, Salvaged
	 	 	 	 
	 
	 	 	 	 
	Latest collection date of Source Plasma, Salvaged
	 	 	 	 
	 
	 	 	 	 
	Total time which the temperature was warmer than -20°C (recorded in hours)
	 	 	 	 
	 
	 	 	 	 
	Warmest temperature reached by freezer
	 	 	 	 
	 
	 	 	 	 
	Number of times plasma was exposed to temperatures warmer than -20°C during the entire freezing
and storage period of the product.
	 	 	 	 
	 
	 	 	 	 
	Incident Report detailing the cause of the incident and CAPA taken (circle yes or no)
	 	Y  /  N	 	 
	 
	 	 	 	 
	All cases marked — “Source Plasma — Salvaged” (circle yes or no)
	 	Y   /  N	 	 
	 
	 	 	 	 
	BOL marked — “Source Plasma — Salvaged” (circle yes or no)
	 	Y   /  N	 	 
	 
	 	 	 	 
	Packing List Summary marked – “Source Plasma – Salvaged” (circle yes or no)
	 	Y   /   N	 	 
	 
	 	 	 	 
	Plasma re-classified/relabeled as Normal plasma if originally hyperimmune plasma (Anti-D plasma
cannot be relabeled as Normal plasma nor shipped as salvaged plasma) (circle yes, no or N/A)
	 	Y  /  N  /  N/A	 	 
	 
	 	 	 	 
	Freezer temperature charts included with submission of Talecris Shipment Request/Approval Form
of Source Plasma, Salvaged accounting for the date plasma was placed in freezer until date of this
request (include period temperature of freezer was warmer than –20°C) (circle yes or no)
	 	Y   /    N	 	 
	 
	 	 	 	 
	Section 2 - To be completed by Talecris Account Manager:
	 	 	 	 
	 
	 	 	 	 
	Talecris Account Manager reviewed supplier’s Incident
Report and found complete and acceptable
	 	Y  /   N	 	 
	 
	 	 	 	 
	Section 3 - To be completed at time of shipment:                       [   ] N/A if Section 2 is answered “NO”.
	 
	 	 	 	 
	Number of times plasma was exposed to temperature warmer
than -20°C during the entire freezing and storage period
	 	 	 	 
	 
	 	 	 	 
	Freezer temperature charts included in shipping document
packet accounting for the entire storage period (circle
yes or no)
	 	Y   /  N	 	 

Plasma Center Manager                                                               
                   Signature/Date

Disposition of Request:                      (Circle One)

	 	 	 	 	 
	                                                             /       
                                  

	 	Approve
	 	Reject
	Talecris Account Manager                               / Date
	 	 	 	 
	 
	 	 	 	 
	                                                             /       
                                  

	 	Approve
	 	Reject
	Talecris Clayton Quality Operations Manager / Date
	 	 	 	 

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 1 of 12

	 	 	 	 	 	 	 
	/s/ Amy W. Durham
	 	2/28/06
	 	/s/ John W. Parrish
	 	2/28/2006
	 
	 	 
	 	 
	 	 
	Document Owner
	 	Date
	 	Quality Approver
	 	Date

			
	 	 	 
	Supercedes:       19-71XX-XXX
	 	Date Effective:     MAR 31 2006

	1.	 	PURPOSE

	 	1.1.	 	To provide and describe the requirements specified by Talecris Biotherapeutics
for the procurement of Source Plasma intended for manufacture of therapeutic biological
products, both domestic and foreign. This specification is intended to assure that
incoming plasma meets all Talecris requirements, in addition to established domestic and
international regulations and standards for Source Plasma.

	2.	 	SCOPE

	 	2.1.	 	These requirements are applicable to all Source Plasma purchased by Talecris.

	3.	 	REFERENCE(S)

	 	3.1.	 	21 CFR 210 — Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General
	 
	 	3.2.	 	21 CFR 211 — Good Manufacturing Practice for Finished Pharmaceuticals
	 
	 	3.3.	 	21 CFR 606 — Current Good Manufacturing Practice for Blood and Blood Components
	 
	 	3.4.	 	21 CFR 610 — General Biological Products Standards
	 
	 	3.5.	 	21 CFR 640 — Additional Standards for Human Blood and Blood Products, Plasma and Source Plasma
	 
	 	3.6.	 	42 CFR 493 — CLIA regulations
	 
	 	3.7.	 	FDA approved Standard Operating Procedures Manuals
	 
	 	3.8.	 	EU Pharmacopoeia monograph for Human Plasma for Fractionation, Revision to Annex
14 to EU Guide to GMP: Manufacture of products derived from human blood or plasma.
	 
	 	3.9.	 	All current FDA guidance documents relating to collecting, testing, processing,
storing or transporting Source Plasma
	 
	 	3.10.	 	RS-000-AA-011 Protocol for Submission of Plasma Samples to Talecris’ RTL
	 
	 	3.11.	 	PPTA Viral Marker Standard, Revised October 26, 2004 and PPTA Viral Marker Data
Collection Form Instructions with attached samples
	 
	 	3.12.	 	PPTA Qualified Donor Standard
	 
	 	3.13.	 	PPTA NAT Testing Standard and NAT Technical Standard
	 
	 	3.14.	 	CS-000-AR-027 Auditing of Plasma Suppliers and Associated Test Laboratories

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris
and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 2 of 12

	 	3.15.	 	CS-000-BE-053 Plasma Supplier Supplemental Directions
	 
	 	3.16.	 	CS-000-BE-057 Method for Evaluating the Suitability of Source Plasma Collection Facilities and Test Laboratories
	 
	 	3.17.	 	EMEA/CHMP/BWP/3794/03 Guideline on the Scientific Data Requirements for A Plasma Master File (PMF)
	 
	 	3.18.	 	EMEA/CHMP/BWP/125/04 Guideline on Epidemiological Data on Blood Transmissible Infections

	4.	 	RESPONSIBILITIES

	 	4.1.	 	Plasma supplier

	 	4.1.1.	 	Assures that all conditions of this specification and supply contract are met.

	 	4.2.	 	Talecris Plasma Operations, Account Manager

	 	4.2.1.	 	Serves as point of contact for all communication with the Plasma Supplier and is
responsible for disseminating information to and from the Plasma Supplier and
appropriate departments within Talecris.
	 
	 	4.2.2.	 	Assists Plasma Supplier in developing and implementing training programs relevant
to new Talecris requirements.
	 
	 	4.2.3.	 	Assists Plasma Supplier in developing and implementing corrective action plans in
response to deficiencies identified in relation to Talecris specifications and
regulatory agency requirements and recommendations.
	 
	 	4.2.4.	 	Conducts periodic review of suppliers’ contractual issues, delivery schedules and
any proposed changes in center operations.
	 
	 	4.2.5.	 	Coordinates the evaluation process for all proposed plasma suppliers, collection
and/or testing facilities.
	 
	 	4.2.6.	 	Communicates to the plasma supplier any quality issues (discrepancies) with
product received.
	 
	 	4.2.7.	 	Coordinates communications between supplier and Talecris concerning
investigations, CAPA and final resolution of product quality issues.

	 	4.3.	 	Talecris Plasma Operations Technical Services Manager

	 	4.3.1.	 	Approves use of specific plasma collection materials and supplies, all packaging
and shipping materials, sample tubes, labels and bar code systems used by plasma
suppliers. These functions may be performed by the Talecris Plasma Operations
Account Managers in the absence of the Technical Services Manager.

	 	4.4.	 	QO Compliance

	 	4.4.1.	 	Maintains Supplier Information Database.
	 
	 	4.4.2.	 	Maintains current files for all plasma suppliers, collection and testing facilities, storage and transport facilities.
	 
	 	4.4.3.	 	Determines, communicates and has final approval of all changes in plasma supplier status and plasma testing facilities.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris
and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 3 of 12

	 	4.4.4.	 	Receives, evaluates and distributes viral marker data in accordance with current regulation requirements.

	 	4.5.	 	Talecris Regulatory Affairs

	 	4.5.1.	 	Maintains and updates Plasma Master File.
	 
	 	4.5.2.	 	Coordinates implementation of any new regulatory requirements.
	 
	 	4.5.3.	 	Files any necessary BPDRs.

	 	4.6.	 	Talecris Quality Operations — Plasma

	 	4.6.1.	 	Communicates to the plasma supplier and appropriate Talecris departments (e.g.
Plasma Ops, QO Compliance) any quality issues (discrepancies) with product
received.
	 
	 	4.6.2.	 	Approves final assessment and disposition of quality issues (discrepancies) arising at collection facilities.
	 
	 	4.6.3.	 	Reviews and dispositions all incoming plasma and modeled manufacturing pools.

	 	4.7.	 	Talecris Plasma Receiving

	 	4.7.1.	 	Receives all incoming plasma shipments.
	 
	 	4.7.2.	 	Receives all plasma notifications regarding the status of units shipped.
	 
	 	4.7.3.	 	Communicates to Talecris QO Plasma and Plasma Operations any discrepancies noted during plasma receipt.

	5.	 	GENERAL REQUIREMENTS

	 	5.1.	 	QO Compliance

	 	5.1.1.	 	Plasma Supplier Approval – All plasma intended for use by Talecris must be
collected by approved suppliers and collection facilities, and tested by approved
laboratories using approved test kits, and stored and transported using approved
establishments.
	 
	 	5.1.2.	 	Supplier Files – All supplier information is maintained by QO Compliance. Copies
of the following documents must be current and updates provided by the supplier,
when applicable:

	 	a.	 	FDA approved ELA, PLA or BLA
	 
	 	b.	 	CLIA registration certificate for the facility
	 
	 	c.	 	Individual state licenses, as required
	 
	 	d.	 	iQPP certification for the collection facility
	 
	 	e.	 	FDA approved SOP manual
	 
	 	f.	 	Epidemiology Data– provided no less than quarterly (compiled
monthly) using the Talecris form (Appendix C).
	 
	 	g.	 	FDA written approval to collect hyperimmune plasma, if
shipped to Talecris.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris
and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 4 of 12

	 	h.	 	The supplier must notify the Talecris Plasma Operations Account Manager of any
changes in the following, at the corporate level, or at an individual facility:

	 	1). 	 	 Facility address or location, phone and fax numbers.
	 
	 	2). 	 	 Hours of operation.
	 
	 	3). 	 	 Management or medical supervisory personnel:

	 	 	 	Lab Director

Medical Director

Physician Substitute

Center Director, Manager or Assistant Manager

Quality Assurance Specialist

Regional Manager

	 	i.	 	The supplier must notify Talecris Plasma Operations Account
Manager prior to any changes in the following:

	 	1). 	 	 Tests performed
	 
	 	2). 	 	 Methods/reagents/equipment or procedures used
	 
	 	3). 	 	 Plasma types collected
	 
	 	4). 	 	 Facility address
	 
	 	5). 	 	 Plasma collection materials

	 	j.	 	For all collection, testing, storage and transport
establishments, the following documentation is required to be provided to
Talecris as soon as it becomes available:

	 	1). 	 	 Copy of EU competent authority certificate,
inspection observations and follow-up/corrective actions.
	 
	 	2). 	 	 U.S. FDA Form 483, inspection observations and
follow-up/corrective actions.

	 	k.	 	For all testing establishments, the following documentation
is required to be provided to Talecris upon request:

	 	1). 	 	 Copies of viral marker tests and NAT validation
reports/data.
	 
	 	2). 	 	 Results of proficiency testing programs.

	 	5.1.3.	 	Compliance Audits — QO Compliance group will conduct audits of all facilities on
a periodic basis, not less than once every 24 months.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris
and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 5 of 12

	 	5.1.4.	 	Epidemiology Data – In accordance with current regulatory requirements and
with some consideration given to the PPTA Viral Marker Standard, epidemiology
data (viral marker serological and NAT), compiled monthly, must be provided
for each facility collecting Source Plasma. The data is required to be
reported to Talecris monthly for the entire year (Jan. 1 through Dec. 31) for
each collection center supplying plasma to Talecris at any point in a given
year regardless of duration of supply during the year. This is necessary to
meet regulatory requirements for an epidemiological profile to be established
and reported for each individual center supplying plasma to the manufacturing
facility.

	 	a.	 	Failure on the part of any collection facility to meet PPTA
(iQPP) Standards will result in the removal of the collection facility from
the approved supplier list.
	 
	 	b.	 	Data must be submitted using the attached form, Appendix C,
by the end of the month following the close of each quarter (i.e.- Q1 due by
4/30, Q2 due by 7/31, Q3 due by 10/31 and Q4 due by 1/31). An alternate format
may be used if requested in writing by the collection organization stating
that the definitions as listed in Appendix C would be adhered to and the
request is subsequently approved in writing by Plasma Operations, Quality
Operations and Regulatory Affairs.
	 
	 	c.	 	Complete the form for each month and follow the instructions
as indicated on the form, Appendix C. Definitions are provided below:

	 	1). 	 	 “First time tested donor” – person whose
blood/plasma is tested for the first time for viral markers without
evidence of prior testing. The first time tested donor population
represents a subset of applicant donors (“applicant donors” that are
tested for the first time in the given system).
	 
	 	2). 	 	 “Repeat tested donor” – person whose blood/plasma
has been tested previously for viral markers in the given system. This
includes “applicant donors” tested for the second time, “applicant
donors” re-qualifying after 6 months or more, and “qualified donors”.
	 
	 	3). 	 	 “Qualified donor” – an individual who has
provided a plasma sample at a specified plasma center, at least twice in
a six month period, and all screening requirements have been met for
both a) questions and tests and for b) the donor and the plasma sample,
according to the iQPP Qualified Donor Standard.
	 
	 	4). 	 	 Total number “First time tested donors” the total
number of unique/individual donors presenting at a center at any time
during the entire reporting calendar year (January 1 to December 31) who
are tested for the first time for viral markers without evidence of
prior testing. Do not count the same donor as identified by the unique
donor ID more than once in a given year. These data should be provided
when the December epidemiology data are reported and is to be a

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris
and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 6 of 12

	 	 	 	comprehensive annual count. When reporting Jan. through Nov.
epidemiology data, simply N/A this box for each center.
	 
	 	5). 	 	 Total number “Repeat tested donors” — the total
number of unique/individual donors presenting at a center at any time
during the entire reporting calendar year (January 1 to December 31) who
have been tested previously for viral markers in the given system. Do
not count the same donor as identified by the unique donor ID more than
once in a given year. These data should be provided when the December
epidemiology data are reported and is to be a comprehensive annual
count. When reporting Jan. through Nov. epidemiology data, simply N/A
this box for each center.
	 
	 	6). 	 	 Total number donations from “Repeat tested
Donors” — the total number of donations collected from Repeat tested
Donors during the entire reporting calendar year (January 1 to December
31). These data should be provided when the December epidemiology data
are reported and is to be a comprehensive annual count. When reporting
Jan. through Nov. epidemiology data, simply N/A this box for each
center.
	 
	 	7). 	 	 Donation frequency — applies only to the “Repeat
tested donors”. This should be calculated as the total number of
donations from “Repeat tested donors” divided by the total number of
“Repeat tested donors” for the entire reporting calendar year (January 1
through December 31) for each center. These data should be provided
when the December epidemiology data are reported. When reporting January
through November epidemiology data, simply N/A this box for each center.
	 
	 	8). 	 	 Confirmed seropositive: donors testing repeat
reactive with a serological screening test (HBsAg, anti-HIV-1/2,
anti-HCV)and who are subsequently confirmed positive by a supplementary
method (Western Blot, RIBA, etc.). Do not count the same donor more
than once in a given year.
	 
	 	9). 	 	 NAT only positive: confirmed positive in a NAT
assay for a specific virus (HIV-1, HCV or HBV), and not found repeat
reactive for that virus in serological screening i.e., window period
cases. NAT only positives may or may not be subsequently confirmed by
serological testing. Do not count the same donor more than once in a
given year.

	 	5.1.5.	 	All plasma suppliers must have a QA program in place, which is consistent with
the current CBER document entitled “Guideline for Quality Assurance in Blood
Establishments”.
	 
	 	5.1.6.	 	Deviations from Talecris Specifications

	 	a.	 	Any proposed deviation to Talecris specification must be
submitted in writing to the Talecris Plasma Operations Account Manager prior
to implementation. Plasma Operations will initiate any required change
control, on which QO disposition will

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris
and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 7 of 12

	 	 	 	be documented.

	 	5.2.	 	Regulatory Affairs

	 	5.2.1.	 	The supplier must notify the Talecris Plasma Operations Account Manager, no
longer than 72 hours/3 working days from discovery, in the event that any of the
following occur, at the corporate level, or at an individual facility:

	 	a.	 	Any fatal donor reaction, as defined in 21 CFR 640.73.
	 
	 	b.	 	Any FDA or other regulatory inspection results that may
affect the approval status of any facility.
	 
	 	c.	 	Any regulatory action (i.e., warning letter, injunction,
suspension) that would adversely affect, or bring into question, the quality
of product produced for Talecris.

	 	5.2.2.	 	The supplier must notify the Talecris Plasma Operations Account Manager and
Clayton Plasma Receiving, and QO within [**] of notification for product seizure or
recall.
	 
	 	5.2.3.	 	The supplier must notify Talecris Plasma Receiving within 72 hours/3 working days
of any lookback notification as detailed in the Table of Actions. Reference section
5.2.2 for product seizure or recall.
	 
	 	5.2.4.	 	The supplier must notify Talecris Plasma Receiving in a timely manner (e.g. as
soon as investigation and unit trace are completed) of any Post Donation
Information notifications (examples, but not limited to, are tattoos, body
piercings, high risk, etc.) as detailed in the Table of Actions. Reference section
5.2.2 for product seizure or recall.
	 
	 	5.2.5.	 	Regulatory actions may result in the removal of a facility from Talecris’ approved supplier list.

	 	5.3.	 	Plasma Operations

	 	5.3.1.	 	Supplier agreements – Each supplier group will sign a written statement agreeing to meet the Talecris specifications.
	 
	 	5.3.2.	 	The Supplier will communicate directly all concerns, questions and changes to the
Talecris Plasma Operations Account Manager assigned to the supplier group, and in
turn, the Account Manager will disseminate, within Talecris, all communications to
and from the Supplier.

	 	5.4.	 	Documents and Records, requirements as defined in 21 CFR 640.72, and in
addition:

	 	5.4.1.	 	Copies of this specification are sent to Plasma Operations Account Managers with
each revision. From the date the specification is approved, the effectivity date
will be stamped one month in advance and sent to plasma suppliers to conduct
training.
	 
	 	5.4.2.	 	All facility documents and records pertaining to the collection, processing,
QA/QC, storage, shipment and testing of plasma intended for manufacture by Talecris
must be available for review for a minimum of 33 years.
	 
	 	5.4.3.	 	Each facility collecting or testing Source Plasma will be assigned a unique
four-digit facility identification code. All documentation and records
accompanying plasma units shipped to Talecris must be clearly identified with the
facility identification code.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris
and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 8 of 12

	 	5.4.4.	 	If original documents are required, but are unavailable, a copy may be substituted
as long as it is stamped with the statement “This is a true and accurate copy of
the original.” Verification must be provided to assure that all copies are
accurate, legible and accounted for.

	 	5.5.	 	European Product

	 	5.5.1.	 	Product intended for shipment to Europe must be collected and tested by EU approved facilities.
	 
	 	5.5.2.	 	EU Requirements are as follows:

	 	a.	 	Inspection and approval by a European Competent Authority.
	 
	 	b.	 	Listed on the Talecris GMP certificate.

	6.	 	DONOR SUITABILITY

	 	6.1.	 	Requirements as defined in 21 CFR 640.61, 640.62, 640.63, 640.65(b), and 640.71 must be met, and in addition:

	 	6.1.1.	 	Applicant donor procedures and policies must be in effect in accordance with the iQPP Qualified Donor Standard.
	 
	 	6.1.2.	 	Donors must be at least 18 years old. Donors older than 65 may donate if an
acceptable physical examination and medical history is acquired annually.
	 
	 	6.1.3.	 	Normal Source Plasma, collected from donors who have been re-entered through FDA
approved re-entry programs, is not acceptable for delivery to or use by Talecris
(except Anti-D plasma, refer to Talecris Anti-D plasma specification for
requirements. No other plasma type, including NX, may be shipped to Talecris from
re-entered donors).
	 
	 	6.1.4.	 	Donors participating in an Anti-D stimulation program are not allowed to
contribute to any other plasma type (NX, TX, HX, CX, RX) shipped to Talecris. Only
Anti-D plasma may be shipped from donors participating in an Anti-D stimulation
program.

	7.	 	PLASMA COLLECTION

	 	7.1.	 	Requirements defined in 21 CFR 640.62, 640.64, 640.65, 640.66, and 640.71 must
be met, and in addition:

	 	7.1.1.	 	Plasma identification systems and labels, plasma collection containers,
anticoagulant, supplies and equipment, sample tubes, and all packaging and shipping
materials used must be approved in writing, prior to use, by Talecris Plasma
Operations, Technical Services (Appendix D).
	 
	 	7.1.2.	 	Only plasma collected in approved bottles using approved anticoagulant solutions
(ref. Appendix D) are allowed to ship to Talecris.
	 
	 	7.1.3.	 	Each collection facility must adhere to PPTA (iQPP) and PPTA voluntary standards.
	 
	 	7.1.4.	 	A FDA approved nomogram must be used.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris
and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 9 of 12

	 	7.1.5.	 	Plasma Identification:

	 	a.	 	A unique Control Number/Bleed Number must be assigned to one
specific unit of plasma and all associated samples, which must be traceable to
an individual donor and donation.
	 
	 	b.	 	The Source Plasma Label applied to the unit of plasma must
also contain the facility identification code, name, address and US license
number of the collection facility, or minimally, the address of the plasma
supplier corporate office.
	 
	 	c.	 	Material Numbers:

	 	1). 	 	 Talecris will determine and provide the
appropriate material number(s) for use by the collection facility.
	 
	 	2). 	 	 In the event that it is ever necessary to change
a material number on plasma already received or in transit to Talecris,
the plasma supplier will communicate this change to the Talecris Plasma
Operations Account Manager.
	 
	 	3). 	 	 In the event that it is necessary to change a
material number on plasma that is in storage at a supplier’s facility,
the supplier will be notified by the Talecris Plasma Operations Account
Manager and requested to correct the shipping documents for the affected
plasma, prior to shipment.

	 	d.	 	The case shipper label must minimally contain the “ship from”
and “ship to” address, the complete vendor batch number, the case number, and
the product description. Reference the example label in CS-000-BE-053, Plasma
Supplier Supplemental Directions, for preferred format and other preferred
label information.

	8.	 	PLASMA PROCESSING

	 	8.1.	 	Requirements defined in 21 CFR 640.68, 640.69(d), 640.70, 640.71 and 640.72 must be met, and in addition:

	 	8.1.1.	 	All plasma units must be placed in the freezer within one hour of collection and maintained at -20°C or colder.
	 
	 	8.1.2.	 	All plasma units must be evaluated for unacceptably high hemoglobin concentration
using the Talecris Hemoglobin Comparator (reference CS-000-BE-053), following the
instructions for use printed on the card. Plasma units with unacceptably high
hemoglobin concentrations must not be shipped to Talecris.

	9.	 	PLASMA PACKING

	 	9.1.	 	Plasma must remain frozen during packing procedures.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris
and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 10 of 12

	10.	 	PLASMA STORAGE

	 	10.1.	 	Requirements defined in 21 CFR 640.71, 640.76 and the EP Monograph for Human
Plasma for Fractionation must be met, and in addition:

	 	10.1.1.	 	Hyperimmune plasma, designated as Salvaged Plasma, must be relabeled as Normal X
plasma. Talecris will not accept salvaged hyperimmune plasma.

	 	 	 	Note: Anti-D plasma cannot be relabeled as Normal X plasma nor shipped as salvaged.

	11.	 	PLASMA SHIPPING

	 	11.1.	 	Requirements defined in 21 CFR 640.71 and 640.76, and in addition:

	 	11.1.1.	 	Maximum volume of normal plasma to be shipped in a vendor batch is 3700 liters.
	 
	 	11.1.2.	 	Plasma Aging — Plasma must not be older than 24 months when shipped to Talecris.
	 
	 	11.1.3.	 	Plasma that falls into one of the following categories is unacceptable for shipment to Talecris:

	 	a.	 	units with reactive or positive test results – refer to
Appendix A-Table of Actions
	 
	 	b.	 	prior and/or subsequent units from TMR or PMR donors – refer
to Appendix A- Table of Actions
	 
	 	c.	 	hemolyzed units, units with red spots in or on the plasma
containers
	 
	 	d.	 	lipemic units
	 
	 	e.	 	units with frozen plasma on the outside of the container
	 
	 	f.	 	broken, cracked or contaminated units
	 
	 	g.	 	untested, or units with incomplete testing
	 
	 	h.	 	orphan units
	 
	 	i.	 	units collected from donors re-entered through a FDA approved
donor re-entry program (except Anti-D plasma, refer to Talecris Anti-D plasma
specification for requirements).
	 
	 	j.	 	recovered plasma
	 
	 	k.	 	unlabeled or mislabeled units, or units with torn or
unreadable labels
	 
	 	l.	 	units tested by a non-approved laboratory, or by non-approved
test methods, reagents or equipment
	 
	 	m.	 	units collected at non-approved facilities or by non approved
owner groups
	 
	 	n.	 	units having errors that breech traceability, such as units
that cannot be traced back to an individual donor
	 
	 	o.	 	 parvo elevated units
	 
	 	p.	 	units with ALT greater than 2 times the upper limit of normal
	 
	 	q.	 	units with < 200 mL / bottle
	 
	 	r.	 	plasma shipped to Talecris out of collection sequence

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris
and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 11 of 12

	 	s.	 	unit(s) with prior notification to supplier of unacceptable status by Talecris

	 	11.1.4.	 	Quarantine Plasma Shipments

	 	a.	 	Quarantined plasma shipments must be pre-approved by CBER.
	 
	 	b.	 	Quarantined plasma shipments must be pre-approved by
Talecris. Notification, in writing, including documentation of CBER approval,
must be provided to the Talecris Plasma Operations Account Manager and written
approval received from Talecris prior to shipment.

	 	11.1.5.	 	Source Plasma — Salvaged

	 	a.	 	Salvaged Plasma shipments must be pre-approved by Talecris.
Notification, in writing, must be provided to the Talecris Plasma Operations
Account Manager and written approval received from Talecris prior to shipment.

	 	11.1.6.	 	A documentation packet must accompany each shipment of plasma and must be QA
approved.
	 
	 	11.1.7.	 	Transport/Carriers and Off-Site Storage

	 	a.	 	All carriers used to transport Source Plasma and off-site
storage facilities must be pre-approved by Talecris.
	 
	 	b.	 	The temperature of the transport trailer must be -25°C or
colder prior to loading the plasma shipment.

	12.	 	TESTING REQUIREMENTS

	 	12.1.	 	Testing requirements as described in 21 CFR 640.67 and 640.71 must be met, and
in addition all plasma units intended for use by Talecris must meet the following
criteria prior to shipment:

	 	 	 
	Test Type	 	Test Requirements
	HBsAG1, 4

	 	Non-reactive3
	Anti-HIV-1/21, 4

	 	Non-reactive3
	Anti-HCV1, 4

	 	Non-reactive3
	ALT4

	 	Less than or equal to 2X the upper limit of normal
	Syphilis4, 7

	 	Negative or Non-reactive3 for donor
	Atypical Antibody2,4,5,6

	 	Negative or Non-detectable (<1:1)
	HCV NAT1,4

	 	Negative3
	HIV NAT1,4

	 	Negative3
	HBV NAT1,4

	 	Negative3
	Parvo, B-19 NAT8

	 	Non-Elevated

 

			
	Notes:
	 
	1.	 	Most current version or generation available of a FDA approved test method must be
used.
	 
	2.	 	Test reagents for atypical antibody screening tests must include specific anti-D antibody.
Detection of other atypical antibodies is not required, except anti-C for Rho-D plasma.
	 
	3.	 	Some manufacturer’s package inserts use the terms “negative” and “non-reactive”
interchangeably.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris
and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 12 of 12

			
	4.	 	Prior to use, the test kit manufacturer, test kit methodology and testing
facility must be approved by Talecris.
	 
	5.	 	Test not performed on anti-D specialty plasma.
	 
	6.	 	Test applicant or qualified donors. Testing must be performed and
acceptable prior to sending units from donor.
	 
	7.	 	Donor test performed every 4 months.
	 
	8.	 	Parvo elevated units are unacceptable to ship to Talecris.

	 	12.2.	 	Testing must be performed by a testing facility that meets all regulatory and
licensing requirements and has been pre-approved by Talecris . The Talecris Director of
Plasma Operations will approve one of the Talecris eligible viral marker testing labs for
each plasma supplier. The Talecris Director will also approve any switch of viral marker
testing laboratories prior to change.
	 
	 	12.3.	 	Notification for Destruction of Plasma

	 	12.3.1.	 	Notification to Talecris Plasma Receiving must be made

	 	a.	 	within three working days/72 hours upon receipt of a reactive
or positive test result for a donor from whom prior or subsequent units have
been shipped to Talecris (lookbacks).
	 
	 	b.	 	within one working day/24 hours of notification of Post
Donation Information resulting in product recalls or seizure concerning units
shipped to Talecris.
	 
	 	c.	 	within a timely manner for Post Donation Information not
resulting in a seizure or recall (example: tattoo, body piercing, high risk).

	 	12.3.2.	 	Concerning instances of owner transfer of plasma centers, the NDDR and Talecris
center code reported on the NDP sent to Talecris must reflect the NDDR / center
code at the time of unit collection (not at time of reporting).

	13.	 	ATTACHMENTS

	 	13.1.	 	Appendix A –Table of Actions – Unacceptable Plasma and Donors
	 
	 	13.2.	 	Appendix B – Glossary of Terms
	 
	 	13.3.	 	Appendix C – Epidemiology Data Form
	 
	 	13.4.	 	Appendix D – List of Approved Materials, Supplies and Vendors

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris
and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS
	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 1 of 12

APPENDIX A — TABLE OF ACTIONS — UNACCEPTABLE PLASMA AND DONORS

	 	 	 	 	 	 	 	 	 
	 	 	 	 	Action on	 	 	 	 
	 	 	Action on This	 	Subsequent	 	Action on Prior	 	Action on
	Test Results or Behavior or Circumstances	 	Donation	 	Donations	 	Donations	 	Donor
	ALT Elevated (greater than 2 x the upper
limit of normal)

	 	Destroy (1)
	 	No Action
	 	No Action
	 	No Action
	 
	 	 	 	 	 	 	 	 
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action
	 
	 	 	 	 	 	 	 	 
	ATYA Positive (Atypical Antibody)

	 	Destroy (1)
	 	Destroy (1)
	 	No Action, unless
the positive unit
was the second
donation from an
applicant donor.
In this case, the
first donation is
also unacceptable
for Talecris.
	 	Not acceptable for

Talecris
	 
	 	 	 	 	 	 	 	 
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action
	 
	 	 	 	 	 	 	 	 
	Parvo, B-19 by NAT Elevated

	 	Destroy (1)
	 	No Action
	 	No Action
	 	No Action

 

			
	Footnotes:	 	(1) — The option to divert plasma units from Talecris is allowed at those plasma
centers that have approved SOPs to do so.

NOTE:

Exceptions to this Table of Actions are to be managed according to directions in section 5.1.6 in the General Specification — Source Plasma .

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris  and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 2 of 12

APPENDIX A — TABLE OF ACTIONS — UNACCEPTABLE PLASMA AND DONORS

	 	 	 	 	 	 	 	 	 
	 	 	 	 	Action on	 	 	 	 
	 	 	Action on This	 	Subsequent	 	Action on Prior	 	 
	Test Results or Behavior or circumstances	 	Donation	 	Donations	 	Donations	 	Action on Donor
	vCJD:

Information or Post Donation Information (PDI) from
a donor who has been diagnosed with vCJD, suspected
vCJD, or CJD diagnosis and Age < 55 years.

	 	Destroy (1)
	 	Destroy (1)
	 	Destroy (1)
LB to
include all in-date
Source Plasma units
	 	PMR
	 
	 	 	 	 	 	 	 	 
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action
	 
	 	 	 	 	 	 	 	 
	CJD:

Information or Post Donation Information (PDI) from a
donor who has been diagnosed with CJD and
Age 3

 55 years

	 	Destroy (1)
	 	Destroy (1)
	 	Destroy (1)
LB not to exceed
3 years from date of center
notification
	 	PMR
	 
	 	 	 	 	 	 	 	 
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action
	 
	 	 	 	 	 	 	 	 
	CJD/vCJD Increased Risk:

Information or Post Donation Information (PDI) from a
donor who has received a dura mater graft, or human
pituitary growth hormone (HPGH).

	 	Destroy (1)
	 	Destroy (1)
	 	Destroy (1)
LB to date of event
	 	PMR
	 
	 	 	 	 	 	 	 	 
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action

 

	Footnotes:

	 	(1)   —
	 	The option to divert plasma units from Talecris is allowed at those plasma
centers that have approved SOPs to do so.
	 
	 

	 	(2)   —
	 	UK Countries include: England, Scotland, Wales, Northern Ireland, Isle of Man, the
Channel Islands, Gilbraltar or the Falkland Islands.

NOTE:

Exceptions to this Table of Actions are to be managed according to directions in section 5.1.6 in the General Specification — Source Plasma.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris  and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 3 of 12

APPENDIX A — TABLE OF ACTIONS — UNACCEPTABLE PLASMA AND DONORS

	 	 	 	 	 	 	 	 	 
	 	 	Action on	 	Action on	 	 	 	 
	 	 	This	 	Subsequent	 	Action on Prior	 	 
	Test Results or Behavior or Circumstances	 	Donation	 	Donations	 	Donations	 	Action on Donor
	CJD/vCJD Potential Risk: 

Donor with a family history of one or more blood
relatives diagnosed with CJD/vCJD, recipient
of bovine-derived insulin since 1980, or who has
accumulated travel or residence in the UK of 3 months
or more between 1980 and 1996,* (2) This information
may be received as PDI.

	 	Destroy (1)
	 	Destroy (1)
	 	Destroy (1)
LB not to exceed 3
years from date of
center notification
for familial risk
	 	PMR for

familial risk
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	Destroy (1)
LB not to exceed 3
years from date of
center notification
	 	Indefinite deferral for
travel risk and bovine
insulin

	 

	 	 	 	 	 	for travel risk and
bovine insulin.	 	 
	 
	 	 	 	 	 	 	 	 
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action

 

	Footnotes:

	 	(1)   —
	 	The option to divert plasma units from Talecris is allowed at those plasma
centers that have approved SOPs to do so.
	 
	 

	 	(2)   —
	 	UK Countries include: England, Scotland, Wales, Northern Ireland, Isle of Man, the
Channel Islands, Gilbraltar or the Falkland Islands.

NOTE:

Exceptions to this Table of Actions are to be managed according to directions in section 5.1.6 in the General Specification — Source Plasma.

*Who has spent 5 years or more cumulatively in France from 1980 to the present or who has received
a transfusion of blood or blood components in the U.K. between 1980 and the present. Additionally,
donors who are former or current U.S. military personnel, civilian military personnel or their
dependents who resided at U.S. military bases in Northern Europe (Germany, United Kingdom, Belgium
and the Netherlands) for 6 months or more, from 1980 through 1990 or, who resided at U.S. military
bases elsewhere in Europe (Greece, Turkey, Spain, Portugal and Italy) for 6 months or more, from
1980 through 1996.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris  and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 4 of 12

APPENDIX A — TABLE OF ACTIONS — UNACCEPTABLE PLASMA AND DONORS

	 	 	 	 	 	 	 	 	 
	Test Results or Behavior	 	Action on This	 	Action on Subsequent	 	 	 	 
	     or Circumstances	 	Donation	 	Donations	 	Action on Prior Donations	 	Action on Donor
	Diagnosed Acute West 

Nile Virus Illness or 

Infection (3)

	 	Destroy (1)
	 	Destroy (1)
Time period to
cover 14 days prior
to the onset of
symptoms and 28
days subsequent to
the onset of
illness.
	 	Destroy (1)
Time period to cover 14
days prior to the onset
of symptoms and 120 days
subsequent to the onset
of illness.
	 	TMR 120 days
following diagnosis
or onset of
illness, whichever
is the later date
	 
	 	 	 	 	 	 	 	 
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action
	 
	 	 	 	 	 	 	 	 
	Suspected Acute West Nile 

Virus Illness or Infection

(2)

	 	Destroy (1)
(if quarantine and
retrieval is
decided by the
center Medical
Director)
	 	N/A
	 	Destroy (1)
(if quarantine and
retrieval is decided by
the center Medical
Director)
LB to 14 days prior to
and 120 days subsequent
to the onset of
symptoms.
	 	TMR 120 days
following diagnosis
or onset of
illness, whichever
is the later date
	 
	 	 	 	 	 	 	 	 
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action

 

	 	 	 	 	 
	Footnotes:

	 	(1)   —
	 	The option to divert plasma units from Talecris is allowed at those plasma
centers that have FDA approval to do so.
	 
	 

	 	(2)   —
	 	According to CBER guidance, the minimum time frame to ask questions regarding
suspected acute WNV infection is from May 1st to November 30th each year. If the plasma
center medical directors suspects a case of acute WNV infection, at any time of year,
the plasma units and plasma donor should be managed as stated in the table of actions.
	 
	 

	 	(3)   —
	 	In the absence of current or recent symptoms, an IgM positive antibody test
result alone should not be grounds for deferral.

NOTE:

Exceptions to this Table of Actions are to be managed according to directions in section 5.1.6 in the General Specification — Source Plasma.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris  and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

\

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 5 of 12

APPENDIX A — TABLE OF ACTIONS — UNACCEPTABLE PLASMA AND DONORS

	 	 	 	 	 	 	 	 	 
	 	 	 	 	Action on	 	 	 	 
	 	 	Action on This	 	Subsequent	 	 	 	 
	Test Results or Behavior or Circumstances	 	Donation	 	Donations	 	Action on Prior Donations	 	Action on Donor
	HBsAg (EIA repeat reactive) or HBV by NAT

	 	Destroy (1)
	 	Destroy (1)
	 	Destroy (1)
LB units 12 months from
last negative donation,
not to exceed 3 years
	 	PMR

(NDDR)
	 
	 	 	 	 	 	 	 	 
	Household Contact or Sexual Partner

	 	Destroy (1)
	 	Destroy (1)
	 	Destroy (1)
LB units 12 months from
date of center
notification
	 	TMR 12 months from
date of last household or
sexual contact.
	 
	 	 	 	 	 	 	 	 
	Anti-HCV (EIA repeat reactive) or HCV by NAT

	 	Destroy (1)
	 	Destroy (1)
	 	Destroy (1)
LB units 12 months from
last negative donation,
not to exceed 3 years
	 	PMR

(NDDR)
	 
	 	 	 	 	 	 	 	 
	Household Contact or Sexual Partner

	 	Destroy (1)
	 	Destroy (1)
	 	Destroy (1)
LB units 12 months from
date of center
notification
	 	TMR 12 months from
date of last household or
sexual contact.
	 
	 	 	 	 	 	 	 	 
	Hepatitis Risk/Behavior: Pre-donation 

History, Clinical Signs or Symptoms

	 	Destroy (1)
	 	Destroy (1)
	 	Destroy (1)
LB units 12 months from
date of center
notification, not to
exceed 3 years
	 	PMR
	 
	 	 	 	 	 	 	 	 
	Household Contact or Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action
	 
	 	 	 	 	 	 	 	 
	IV Drug User: Past or present

	 	Destroy (1)
	 	Destroy (1)
	 	Destroy (1)
LB units 12 months from
date of center
notification
	 	PMR
	 
	 	 	 	 	 	 	 	 
	Sexual Partner

	 	Destroy (1)
	 	Destroy (1)
	 	Destroy (1)
LB units 12 months from
date of center
notification
	 	TMR 12 months from
date of last sexual
contact

 

			
	Footnotes:	 	(1) — The option to divert plasma units from Talecris is allowed at those plasma centers that have FDA approval to do so.

NOTE:

Exceptions to this Table of Actions are to be managed according to directions in section 5.1.6 in the General Specification — Source Plasma.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris  and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 6 of 12

APPENDIX
A — TABLE OF ACTIONS — UNACCEPTABLE PLASMA AND DONORS

	 	 	 	 	 	 	 	 	 
	 	 	 	 	Action on	 	 	 	 
	 	 	Action on This	 	Subsequent	 	 	 	 
	Test Results or Behavior or Circumstances	 	Donation	 	Donations	 	Action on Prior Donations	 	Action on Donor
	PDI-Post Donation Information received
describing possible exposure to Hepatitis or
HIV

	 	Destroy (1)
	 	Destroy (1)
	 	Destroy (1)
LB units 12 months to
date of exposure, not to
exceed 12 months
	 	TMR for 12 months
from date of
exposure
	 
	 	 	 	 	 	 	 	 
	Household Contact (2) or Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action
	 
	 	 	 	 	 	 	 	 
	Anti-HCV-1/2 (EIA repeat reactive), AIDS or HIV 

risk

	 	Destroy (1)
	 	Destroy (1)
	 	Destroy (1)
LB units 6 months from
last negative donation,
not to exceed 3 years
	 	PMR

(NDDR) (3)
	 
	 	 	 	 	 	 	 	 
	Sexual Partner

	 	Destroy (1)
	 	Destroy (1)
	 	Destroy (1)
LB units 6 months from
date of center
notification
	 	TMR 12 months from
date of last sexual
contact
	 
	 	 	 	 	 	 	 	 
	HIV-1 NAT

	 	Destroy (1)
	 	Destroy (1)
	 	Destroy (1)
LB units 3 months from
last negative donation,
not to exceed 3 years
	 	PMR

(NDDR)
	 
	 	 	 	 	 	 	 	 
	Sexual Partner

	 	Destroy (1)
	 	Destroy (1)
	 	Destroy (1)
LB units 3 months from
date of center
notification
	 	TMR 12 months from
date of last sexual
contact

 

					
	Footnotes:

	 	(1)    —
	 	The option to divert plasma units from Talecris is allowed at those plasma
centers that have FDA approval to do so.
	 
	 

	 	(2)    —
	 	Applies to exposure to Hepatitis only.
	 
	 

	 	(3)    —
	 	NDDR notification is for reactive results only; not for high risk.

NOTE:

Exceptions to this Table of Actions are to be managed according to directions in section 5.1.6 in the General Specification — Source Plasma.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris  and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 7 of 12

APPENDIX A — TABLE OF ACTIONS — UNACCEPTABLE PLASMA AND DONORS

	 	 	 	 	 	 	 	 	 
	 	 	Action on	 	Action on	 	 	 	 
	 	 	This	 	Subsequent	 	 	 	 
	Test Results or Behavior or Circumstances	 	Donation	 	Donations	 	Action on Prior Donations	 	Action on Donor
	Syphilis, confirmatory positive or confirmatory not performed

	 	Destroy (1)
	 	Destroy (1)
	 	No Action
	 	Not acceptable for

Talecris
	 
	 	 	 	 	 	 	 	 
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	TMR 12 months from
date of last sexual
contact
	 
	 	 	 	 	 	 	 	 
	Syphilis positive, confirmatory negative

	 	No Action
	 	No Action
	 	No Action
	 	No action if

approved for

further donations

by the Medical

Supervisor (2)
	 
	 	 	 	 	 	 	 	 
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action

 

	 	 	 	 	 
	Footnotes:

	 	(1)    —
	 	The option to divert plasma units from Talecris is allowed at those plasma
centers that have FDA approval to do so.
	 
	 

	 	(2)    —
	 	FDA requires a licensed physician to approve donor for further donations.

NOTE:

Exceptions to this Table of Actions are to be managed according to directions in section 5.1.6 in the General Specification — Source Plasma.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris  and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 	 	 
	Talecris

	 	 	 	PURCHASE SPECIFICATION
	 	SAP MATERIAL #: N/A
	     BIOTHERAPEUTICS

	 	 	 	 	 	REVISION: 023
	 

	 	TITLE:
	 	GENERAL SPECIFICATION – SOURCE PLASMA
	 	PAGE 8 of 12

APPENDIX A — TABLE OF ACTIONS – UNACCEPTABLE PLASMA AND DONORS

	 	 	 	 	 	 	 	 	 
	Test Results or	 	 	 	 	 	 	 	 
	Behavior	 	Action on this	 	Action on subsequent	 	Action on prior	 	 
	or Circumstances	 	donation	 	donations	 	donations	 	Action on the Donor
	Donors reporting a
history of SARS or
suspected SARS

	 	Destroy (1)
	 	Destroy (1)

Time period to
cover 28 days after
complete symptom
resolution AND the
cessation of any
treatment
	 	Destroy (1)

LB to date of
exposure
	 	TMR until 28 days after
complete symptom resolution
AND the cessation of any
treatment
	Close Contact (2)

          OR

Travel / Residence 

Exposure

	 	Destroy (1)(3)
	 	Destroy (1)(3)

Time period to
cover NLT 14 days
after last exposure
OR 14 days after
arrival in the US
if travel/residence
exposure
	 	Destroy (1)(3)

LB to date of
exposure
	 	TMR for NLT 14 days after last
exposure OR for
14 days after arrival in the US
if travel/residence
exposure

 

	 	 	 	 	 	 	 	 	 
	Footnotes:

	 	 	(1	)	 	–
	 	The option to divert plasma units from Talecris is allowed at those plasma
centers that have FDA approval to do so.
	 	 	 	 	 	 	 	 	 
	 

	 	 	(2	)	 	–
	 	Close contact is defined as having cared for, having lived with, or having had
direct contact with respiratory secretions and/or body fluids of a patient known to be a
suspect. SARS case.
	 	 	 	 	 	 	 	 	 
	 

	 	 	(3	)	 	–
	 	If the donor is symptom-free more than 14 days post-exposure, product retrieval
and quarantine are not necessary.

NOTE:

Exceptions to this Table of Actions are to be managed according to directions in section 5.1.6 in the General Specification – Source Plasma.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with
 matters authorized by Talecris and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 	 	 
	Talecris

	 	 	 	PURCHASE SPECIFICATION
	 	SAP MATERIAL #: N/A
	     BIOTHERAPEUTICS

	 	 	 	 	 	REVISION: 023
	 

	 	TITLE:
	 	GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 9 of 12

APPENDIX A — TABLE OF ACTIONS — UNACCEPTABLE PLASMA AND DONORS

	 	 	 	 	 	 	 	 	 
	Test Results or	 	Action on	 	 	 	 	 	 
	Behavior	 	this	 	Action on subsequent	 	 	 	 
	or Circumstances	 	donation	 	donations	 	Action on prior donations	 	Action on the Donor
	Recipient of
Smallpox
Vaccine –
WITHOUT
Vaccine
Complications

	 	Destroy (1)
	 	A) Destroy — Time Period to
Cover Date of Smallpox
Vaccination and date the scab
spontaneously separated or 21 days
whichever is longer.

B) Destroy — Time Period to
Cover Date of Smallpox
Vaccination and 2 months after
Vaccination.
	 	A) Destroy — Time Period to Cover Date
of Smallpox Vaccination and date the
scab spontaneously separated or 21 days
whichever is longer. 

B) Destroy — Time Period to Cover Date
of Smallpox Vaccination and 2 months after
vaccination.
	 	A) TMR until the vaccination
scab has separated
spontaneously, or for 21 days
post-vaccination, whichever is
the later date. 

B) If scab was removed prior
to separating spontaneously,
TMR for 2 months after
vaccination.
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action
	 
	 	 	 	 	 	 	 	 
	Recipient of
Smallpox
Vaccine – With
Vaccine
Complications

	 	Destroy (1)
	 	Destroy — Time Period to Cover
Date of Smallpox Vaccination and
14 days after all vaccine
complications have completely
resolved.
	 	Destroy — Time Period to Cover Date of
Smallpox Vaccination and 14 days after
all vaccine complications have completely
resolved.
	 	TMR until 14 days after all
vaccine complications have
completely resolved.
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action
	 
	 	 	 	 	 	 	 	 
	Recipient of
Antrax
Vaccine

	 	No Action
	 	No Action
	 	No Action
	 	TMR 48 hours from time of
vaccination.

 

	 	 	 	 	 	 	 	 	 
	Footnotes:

	 	 	(1	)	 	–
	 	The option to divert plasma units from Talecris is allowed at those plasma
centers that have FDA approval to do so.

NOTE:

Exceptions to this Table of Actions are to be managed according to directions in section 5.1.6 in the General Specification — Source Plasma.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with
 matters authorized by Talecris and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 	 	 
	Talecris

	 	 	 	PURCHASE SPECIFICATION
	 	SAP MATERIAL #: N/A
	     BIOTHERAPEUTICS

	 	 	 	 	 	REVISION: 023
	 

	 	TITLE:
	 	GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 10 of 12

APPENDIX A — TABLE OF ACTIONS — UNACCEPTABLE PLASMA AND DONORS

	 	 	 	 	 	 	 	 	 
	Test Results or	 	Action on	 	 	 	 	 	 
	Behavior	 	this	 	Action on subsequent	 	 	 	 
	or Circumstances	 	donation	 	donations	 	Action on prior donations	 	Action on the Donor
	Symptomatic 

Contacts (of 

Smallpox 

Vaccinees) 

Exhibiting 

Localized Skin 

Lesions with No 

Other 

Complications

	 	Destroy (1)
	 	A) Destroy – Time Period to
Cover Date of Contact with
Smallpox Vaccinee (if known) and
date the scab spontaneously
separated.

B) Destroy – Time Period to
Cover Date of Contact with
Smallpox Vaccinee (if known) and
3 months from the date of
vaccination of the vaccine
recipient with whom contact
occurred or for 2 months from the
present if the vaccination date is
not known.
	 	A) Destroy – Time Period to Cover Date
of Contact with Smallpox Vaccinee (if
known) and date the scab spontaneously
separated. 

B) Destroy – Time Period to Cover Date
of Contact with Smallpox Vaccinee (if
known) and 3 months from the date of
vaccination of the vaccine recipient with
whom contact occurred or for 2 months
from the present if the vaccination date is
not known.
	 	A) If the scab separated
spontaneously, no action
is taken.

B) If the scab was removed
prior to separating spontaneously, TMR for 3
months from the date or
vaccination of the vaccine
recipient with whom
contact occurred or for 2
months from the present if
the vaccination date is
not known.
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action
	 
	 	 	 	 	 	 	 	 
	Symptomatic 

Contacts (of 

Smallpox Vaccinees) 

Exhibiting 

Vaccine 

Complications

	 	Destroy (1)
	 	Destroy – Time Period to Cover
Date of Contact with Smallpox
Vaccinee (if known) and 14 days
after all vaccine complications
have completely resolved.
	 	Destroy – Time Period to Cover Date of
Contact with Smallpox Vaccinee (if
known) and 14 days after all vaccine
complications have completely resolved.
	 	TMR until 14 days after all
vaccine complications have
completely resolved.
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action

 

	 	 	 	 	 	 	 	 	 
	Footnotes:

	 	 	(1	)	 	–
	 	The option to divert plasma units from Talecris is allowed at those plasma
centers that have FDA approval to do so.

NOTE:

Exceptions to this Table of Actions are to be managed according to directions in section 5.1.6 in the General Specification – Source
Plasma.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with
 matters authorized by Talecris and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 	 	 
	Talecris

	 	 	 	PURCHASE SPECIFICATION
	 	SAP MATERIAL #: N/A
	     BIOTHERAPEUTICS

	 	 	 	 	 	REVISION: 023
	 

	 	TITLE:
	 	GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 11 of 12

APPENDIX A — TABLE OF ACTIONS – UNACCEPTABLE PLASMA AND DONORS

	 	 	 	 	 	 	 	 	 
	Test Results or	 	Action on	 	 	 	 	 	 
	Behavior or	 	this	 	Action on subsequent	 	 	 	 
	Circumstances	 	donation	 	donations	 	Action on prior donations	 	Action on the Donor
	Vaccines with 

killed /inactivated 

viruses or 

bacteria 

recombinant, 

OR 

Toxoids

	 	No Action
	 	No Action
	 	No Action
	 	No Action
if donor is acceptable
according to the center
medical director or supervisor.
	 
	 	 	 	 	 	 	 	 
	Vaccines with 

attenuated 

bacteria or 

viruses

	 	No Action
	 	No Action
	 	No Action
	 	TMR for 4 weeks
from vaccination date.
	 
	 	 	 	 	 	 	 	 
	Other Vaccines: 

Rabies, tick-

borne 

encephalitis

	 	No Action
	 	No Action
	 	No Action
	 	No Action
if donor is acceptable
according to the center
medical director or supervisor.

OR 

TMR for 1 year if vaccine
was administered post-exposure.
Deferral period is from last
exposure to rabies.

 

NOTE:

Exceptions to this Table of Actions are to be managed according to directions in section 5.1.6 in the General Specification –
Source Plasma.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with
 matters authorized by Talecris and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 	 	 
	Talecris

	 	 	 	PURCHASE SPECIFICATION
	 	SAP MATERIAL #: N/A
	     BIOTHERAPEUTICS

	 	 	 	 	 	REVISION: 023
	 

	 	TITLE:
	 	GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 12 of 12

APPENDIX A — TABLE OF ACTIONS – UNACCEPTABLE PLASMA AND DONORS

	 	 	 	 	 	 	 	 	 
	Test Results or	 	 	 	 	 	 	 	 
	Behavior or	 	Action on this	 	Action on subsequent	 	 	 	 
	Circumstances	 	donation	 	donations	 	Action on prior donations	 	Action on the Donor
	Confirmed
Medical Diagnosis
of Anthrax of Any
Form

	 	Destroy (1)

	 	Destroy (1)

Time period to
cover known date of
exposure to Anthrax
or 60 days prior to
the onset of
illness until the
condition is
considered resolved
	 	Destroy (1)

Time period to cover
known date of exposure
to Anthrax or 60 days
prior to the onset of
illness, whichever is
the shorter period
	 	TMR until donor
completes a full
course of
appropriate
treatment and
condition is
considered
resolved.
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action
	 
	 	 	 	 	 	 	 	 
	Proven Anthrax 

Bacterial 

Colonization

	 	No Action
	 	No Action
	 	No Action
	 	TMR until donor
completes a full
course of
prophylaxis with an
appropriate
antibiotic.
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action
	 
	 	 	 	 	 	 	 	 
	Undiagnosed
Skin Lesions
Expected to be
Anthrax

	 	No Action
	 	No Action
	 	No Action
	 	TMR until either
donor lesion is
proven not to be
Anthrax or donor
completes full
course of
appropriate
treatment and
condition is
considered
resolved.
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action
	 
	 	 	 	 	 	 	 	 
	Undiagnosed
Post-Donation
Illness in
Individuals
Potentially Exposed
to Anthrax

	 	Destroy (1)

(if quarantine and
retrieval is
decided by the
center Medical
Director)
	 	N/A
	 	Destroy (1)

(if quarantine and
retrieval is decided by
the center Medical
Director) Time period to
cover known date of
exposure to Anthrax or
60 days prior to the
onset of illness,
whichever is the shorter
period
	 	TMR until condition
is considered
resolved.
	Sexual Partner

	 	No Action
	 	No Action
	 	No Action
	 	No Action

 

	 	 	 	 	 	 	 	 	 
	Footnotes:

	 	 	(1	)	 	–
	 	The option to divert plasma units from Talecris is allowed at those plasma
centers that have FDA approval to do so.

NOTE:

Exceptions to this Table of Actions are to be managed according to directions in section 5.1.6 in
the General Specification – Source Plasma.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with
 matters authorized by Talecris and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 1 of 3

APPENDIX B – GLOSSARY OF TERMS

Applicant Donor – A donor who has not acquired Qualified Donor Status or has had a lapse of six
months or more between donations.

BPDR – Biological Product Deviation Report

SAP Case Number – Identifies the individual case of plasma within the vendor batch. The SAP
case number cannot be duplicated within a given vendor batch.

CAPA – Corrective Action(s) and/or preventive action(s).

Catalog Number - see Plasma Material Numbers.

Control Number / Bleed Number - A unique plasma unit identification number.

CTR - Confidential Test Report – a form generated by RTL which serves as notification that a
sample tested is reactive or positive for one of the required NAT tests.

Donor Number – A unique number assigned to each individual donor at the first donation, which
is used to identify that individual donor throughout their donation history at a particular
collection facility.

Facility Identification Code — A unique four character (usually alpha) code assigned by
Talecris to identify plasma center and test facility locations.

Household Contact – Persons who have been in close contact with a case of hepatitis infection
(acute or chronic).

ITS – Incident Tracking System captures the investigations and documents related to discrepant
plasma reports that have been shipped and found at check-in by Talecris (RMR) or already
processed by Talecris (ITS).

Last Negative Donation – For the purposes of evaluating lookback reporting timeframes, the last
negative donation is applicable to both NAT and viral marker testing.

LB – Lookback. Plasma unit with acceptable viral marker testing associated with a donor who
has either subsequently seroconverted, is initially reactive or is otherwise determined to be
unacceptable.

NAT – Nucleic Acid Amplification Technology.

NDDR – National Donor Deferral Registry.

NDP – Notification for Destruction of Plasma form to be submitted to Talecris in the event
plasma unit removal or disposition is required.

Orphan Unit - The first unit of plasma donated by an Applicant Donor, for which a second unit
is not collected or successfully tested within six months of the first unit. An orphan unit is
unacceptable for shipment to Talecris.

Plasma Material Numbers – Plasma types are assigned 8-digit Material Numbers that numerically
code for the type antibody present in the plasma, as well as other important characteristics,
such as EU product eligibility and level of NAT testing.

Note: Plasma material numbers were formerly referred to as plasma item numbers. The
correspondence between the current material numbers and the legacy item numbers is
detailed in the table below:

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with
matters authorized by Talecris and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 2 of 3

APPENDIX B

	 	 	 	 	 	 	 	 	 
	PLASMA DESCRIPTION	 	PLASMA MATERIAL #	 	LEGACY ITEM #
	Normal, EU approved, bottles
	 	 	08634958	 	 	 	19-7100-110	 
	Normal, non-EU approved, bottles
	 	 	08634966	 	 	 	19-7100-111	 
	Normal, EU “Flash Frozen” approved, all products, bottles
	 	 	08754430	 	 	 	N/A	 
	Normal, EU approved from Configured Pools (ZLB)
	 	 	08936601	 	 	 	N/A	 
	CMV, EU approved, bottles
	 	 	08635318	 	 	 	19-7122-110	 
	CMV, non-EU approved, bottles
	 	 	08635326	 	 	 	19-7122-111	 
	Tetanus, non-EU approved, bottles
	 	 	08635024	 	 	 	19-7103-111	 
	Rabies, non-EU approved, bottles
	 	 	08635083	 	 	 	19-7106-111	 
	Anti-D, non-EU approved, bottles
	 	 	08635156	 	 	 	19-7108-111	 
	Hepatitis, non-EU approved, bottles
	 	 	08635458	 	 	 	19-7145-111	 

PLS – Packing List Summary – the form to be completed for each individual Vendor Batch Number.

PMR - Permanent Medical Reject - The status of a donor who has been permanently deferred from
donating Source Plasma due to an unacceptable medical condition, unacceptable test results or
post donation information.

PPL – Plasma Packing List – The form used to document plasma units in individual cases and test
results for each plasma unit (or certification of negative test results).

PPTR – Plasma Packing & Test Report – A form generated by Raleigh Test Lab (RTL), listing test
results for samples tested by NAT.

Qualified Donor - An individual who has provided a plasma sample at a specified plasma center,
at least twice in a six month period, and all screening requirements have been met for both a)
questions and tests and for b) the donor and the plasma sample, according to the iQPP Qualified
Donor Standard.

QO – Talecris Quality Operations Department, comprising of both Quality Assurance and Quality
Control functions.

RA – Regulatory Affairs

RMR – Raw Material Report. A report used to document discrepancies against plasma not yet
processed (pooled).

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The
information is confidential and is to be used only in connection with
matters authorized by Talecris and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 3 of 3

APPENDIX B

Shipment –

	 	a.	 	Single Shipment: refers to a shipment from a single plasma center that meets
all requirements stated in the general specification.
	 
	 	b.	 	Combined Shipment or “Master Ship Documents”: expands the definition of
shipment to include hyperimmune plasma shipped from multiple locations, all belonging
to the same owner group. All centers are to be listed on Talecris’ approved
suppliers list. Combined shipments must not exceed 500 liters and must be pooled
together.

Source Plasma - The fluid portion of human blood collected by plasmapheresis which meets the
requirements of US CFR Title 21, Part 640, Subpart G – Source Plasma and is intended for further
manufacture into therapeutic biological products.

Source Plasma, Salvaged – Source Plasma that is exposed to a temperature fluctuation that falls
between -5°C, but colder than +10°C, or that is exposed to more than one temperature excursion
warmer than -20°C during storage.

Supplier – A supplier of plasma units, or of testing services provided for samples from plasma
units intended for shipment to and manufacture by Talecris.

TMR - Temporary Medical Reject - the status of a donor who has been temporarily deferred from
donating Source Plasma due to a transient medical condition.

Vendor Batch Number – Identifies the shipment to Talecris. The vendor batch number is a unique
identifier that is NEVER duplicated at the same center. Whenever a shipment comprises more than
one plasma type, a unique vendor batch number must be assigned to each plasma type within the
shipment. The first four (4) characters of the vendor Batch number must be the donor centers
NDDR number.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with
matters authorized by Talecris and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 1 of 1

Appendix C

Epidemiology Data1

Monthly Data Collection Form

	 	 	 	 	 
	 

	 	To:
	 	QO Compliance/Audits & Systems – Epidemiology Data
	 

	 	 	 	Fax: (919) 359-7195

	 	 	 	 	 	 	 	 	 	 	 
	Month (1 only):
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	Owner Group:
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	Submitted By:

	 	 	 	Phone:
	 	 	 	Date:	 	 
	 

	 	 
	 	 	 	 
	 	 	 	 
	Signature:
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Total #	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Total #	 	 	 	 	 	 	Donations	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	“First	 	 	Total #	 	 	from	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Time	 	 	“Repeat	 	 	“Repeat	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Center	 	 	 	 	 	tested	 	 	tested	 	 	tested	 	 	Donation	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Code	 	NDDR #	 	 	Donors”	 	 	Donors”	 	 	Donors”	 	 	Frequency4	 	 	Anti-HIV-1/2	 	 	Anti-HCV	 	 	HBsAg	 	 	HIV-1 NAT	 	 	HCV NAT	 	 	HBV NAT	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	FTD2	 	 	RD3	 	 	QD5	 	 	FTD2	 	 	RD3	 	 	QD5	 	 	FTD2	 	 	RD3	 	 	QD5	 	 	FTD2	 	 	RD3	 	 	QD5	 	 	FTD2	 	 	RD3	 	 	QD5	 	 	FTD2	 	 	RD3	 	 	QD5	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

 

Note: Viral Marker and NAT results are confirmed positive.

 

			
	1	 	Follow the definitions provided in section 5.1.4 of the General Specification – Source Plasma.
	 
	2	 	In all cases, FTD is to be representative of the number of confirmed positive “First time tested donors” (not donations).
	 
	3	 	In all cases, RD is to be representative of the number of confirmed positive “Repeat tested donors” (not donations).
	 
	4	 	In all cases, NAT refers to NAT only positives (donors testing NAT positive but not repeat reactive by EIA).
	 
	5	 	In all cases, QD is to be representative of the number of confirmed positive “Qualified donors” for the entire calendar year.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with
matters authorized by Talecris and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 1 of 2

APPENDIX D – PLASMA COLLECTION EQUIPMENT AND SUPPLIES

	 	 	 	 	 	 	 
	Product	 	Part Number/Description	 	Purpose	 	Acceptable Materials
	 

	 	 	 	 	 	Both Medisystems and JMS are included in the Talecris Plasma Master File
	Apheresis Needle Set:
	 	 	 	 	 	 
	15g

	 	Medisystems/P9-9115MGLB (Medisystems code)	 	 	 	 
	16g

	 	Medisystems/P9-9116MGLB (Medisystems code)/Baxter number 4R2440
	 	Access donor’s vein	 	 
	175

	 	Medisystems/P9-9117MGLB (Medisystems code)/Baxter number 4R2441	 	 	 	 
	15g

	 	JMS/820-1504	 	 	 	 
	16g

	 	JMS/820-1609	 	 	 	 
	17g

	 	JMS/820-1702	 	 	 	 
	 

	 	 	 	 	 	Two automated systems are licensed in the U.S. for collecting Source
Plasma: Haemonetics PCS/PCS2 and Baxter Autopheresis-C (Plasmacell-C
disposable)
	 
	 	 	 	 	 	 
	Plasma Separation Device:

	 	 	 	Separate plasma from whole blood	 	 
	Apheresis bowl

	 	Haemonetics/L/N: 625B	 	 	 	 
	PCS2 harness

	 	Haemonetics/L/N: 620	 	 	 	 
	or Plasmacell-C kit

	 	Baxter/Fenwal/4R2256	 	 	 	 
	 

	 	 	 	 	 	Baxter and Haemonetics both make
comparable FDA- licensed USP
solutions, which are listed in the PMF.
	 
	 	 	 	 	 	 
	Anticoagulant:

	 	 	 	 	 	 
	 

	 	 	 	Prevent plasma from clotting	 	 
	4% Citrate, USP, 250 mL

	 	Haemonetics/L/N: 420A (US)	 	 	 	 
	4% Citrate, USP, 250 mL

	 	Baxter/Fenwal/4B7867Q	 	 	 	 
	4% Citrate, USP, 500 mL

	 	Baxter/Fenwal/4B7889Q	 	 	 	 
	 

	 	 	 	Plasma Collection/Storage Container
	 	- Baxter plasma bottles
	 
	 	 	 	 	 	 
	Plasma Container:

	 	 	 	 
	 	- Haemonetics plasma bottles
	Plasma Bottle (PlasmaLink)

	 	Baxter/Fenwal/4R2067, 4R2068	 	 	 	 
	Plasma Bottle

	 	Haemonetics 694, 694S, 694D	 	 	 	 

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The information is confidential and is to be used only in connection with matters authorized by Talecris and
no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

	 	 	 	 	 
	Talecris

     BIOTHERAPEUTICS

	 	PURCHASE SPECIFICATION

	 	SAP MATERIAL #: N/A

REVISION: 023
	 

	 	TITLE: GENERAL SPECIFICATION — SOURCE PLASMA
	 	PAGE 2 of 2

APPENDIX D – PLASMA COLLECTION EQUIPMENT AND SUPPLIES

	 	 	 	 	 	 	 
	Product	 	Part Number/Description	 	Purpose	 	Acceptable Materials
	NAT Sample tray:

	 	All-Pak/HMS-Zero
	 	NAT Sample Submission to RTL
	 	MUST be manufacturer and P/N specified
	NAT Sample Shipper:

	 	All-Pak/HMS-69100
	 	NAT Sample Submission to RTL
	 	MUST be manufacturer and P/N specified
	Gel Packs:

	 	Tech Pak/ Frigid 15, All-Pak/SturdeeSeal
	 	NAT Sample Submission to RTL
	 	MUST be manufacturer and P/N specified
	Sigma Printing System:

	 	Allegro printer, BLS memory module, media kits
	 	labeling documents for NAT samples and plasma cases
	 	All centers NAT tested by Talecris RTL (Raleigh Test Lab) are furnished this equipment by Talecris
	Plasma Shipper:

	 	Corrugated plasma shipping carton
	 	Plasma Shipments to Clayton
	 	Prior approval by Manager of Technical Services of Plasma Operations.
	Shipper Label:

	 	various Talecris catalog #’s/(81-9999 series) Teslin material
	 	Plasma Shipments to Clayton
	 	Printed by Universal Graphics. Alternates acceptable if pre-approved by Manager of Technical
Service, Plasma Operations.

CONFIDENTIAL

This material is the property of Talecris Biotherapeutics, Inc. The
information is confidential and is to be used only in connection with
matters authorized by Talecris and no part of it is to be disclosed to others without prior written permission from Talecris.

 

 

Exhibit D

MONTH            Jun-2006

Emergent — Anthrax Hyperimmune

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Month
	 	Date	 	 	Talecris Employee	 	 	Hours	 	 	 	 	 	 	Task/Subproject	 	 	Description	 	 	Dept	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	0	 	 	 	 	 	 	Total Hours	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	$[**] per hour	 	 	 	 	 	Rate	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Invoice	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

Timesheets represent billable hours to Emergent and are required backup for invoicing. Externals are billed as passthru costs.

An average rate of $[**] per hour, plus any relevant travel expenses, for billing purposes regarding supplemental Talecris support regardless of functional area.

The detailed invoices will be submitted on a monthly basis using this form

 

Exhibit E

APPENDIX II

Summary of Responsibilities

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	RESPONSIBILITY
	 	 	 	 	 	 	Stage(s) of Manufacturing
	 	 	 	 	 	 	[**]	 	[**]
	Topic	 	Emergent	 	Talecris	 	Emergent	 	Talecris
	 
	GENERAL COMPLIANCE / REGULATORY	 	[**]	 	[**]	 	[**]	 	[**]
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	a.
	 	License holder with respect to Shared
Manufacturing License process	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Compliance with US CFR / cGMP regulations during manufacture	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	BATCH RECORDS	 	[**]	 	[**]	 	[**]	 	[**]
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	a.
	 	Write Master Production Records	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Review Master Production Records	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Approve Master Production Records	 	 	 	 	 	 	 	 
	 

	 	d.
	 	Approval of changes to Master Batch
Records that would have an effect on
product	 	 	 	 	 	 	 	 
	 

	 	e.
	 	Provide copies of approved Master
Production Records and executed Production
Batch Records	 	 	 	 	 	 	 	 
	 

	 	f.
	 	Record Retention (original documents –
Master Batch Records and executed Batch
Records)	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	MATERIAL CONTROLS	 	[**]	 	[**]	 	[**]	 	[**]
	 

	 	a.
	 	Responsibility to ensure source AIG
plasma meets established plasma
specification	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Responsibility to ensure all components
and raw materials used in the manufacturing
process meet pre-approved specifications	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	SUBCONTRACTING	 	[**]	 	[**]	 	[**]	 	[**]
	 

	 	a.
	 	Notification of intent/need to
subcontract	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Right to audit potential subcontractor
accompanied by Talecris	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Prior approval to initiate subcontracting	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	REPROCESSING / REWORK PER VALIDATED PROCEDURES 

AND LICENSE	 	[**]	 	[**]	 	[**]	 	[**]
	 

	 	a.
	 	Rework according to Talecris and
Emergent approved license and validated
procedures	 	 	 	 	 	 	 	 

 

 

Exhibit E

APPENDIX II

Summary of Responsibilities

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	RESPONSIBILITY
	 	 	 	 	 	 	Stage(s) of Manufacturing
	 	 	 	 	 	 	[**]	 	[**]
	Topic	 	Emergent	 	Talecris	 	Emergent	 	Talecris
	 
	SPECIFICATIONS	 	[**]	 	[**]	 	[**]	 	[**]
	 

	 	a.
	 	Product Specifications, [**]	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Product Specification – [**]	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Labeling and packaging components	 	 	 	 	 	 	 	 
	 

	 	d.
	 	Packaging inserts	 	 	 	 	 	 	 	 
	 

	 	e.
	 	Compatibility with equipment	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	STABILITY – Finished Product	 	[**]	 	[**]	 	[**]	 	[**]
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	a.
	 	Writing stability protocol	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Approving stability protocol	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Collection / storage of stability
samples	 	 	 	 	 	 	 	 
	 

	 	d.
	 	Testing – [**]	 	 	 	 	 	 	 	 
	 

	 	e.
	 	Stability data interpretation – [**]	 	 	 	 	 	 	 	 
	 

	 	f.
	 	Testing – [**]	 	 	 	 	 	 	 	 
	 

	 	g.
	 	Writing stability report	 	 	 	 	 	 	 	 
	 

	 	h.
	 	Approving stability report	 	 	 	 	 	 	 	 
	 

	 	i.
	 	Establish expiration date/shelf life	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	PRODUCT RETAINS	 	[**]	 	[**]	 	[**]	 	[**]
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	a.
	 	Identification of samples to be retained	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Approval of samples to be retained	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Retention / storage of samples at
appropriate storage conditions	 	 	 	 	 	 	 	 
	 

	 	d.
	 	Final disposition of retain samples	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	PRODUCT RELEASE	 	[**]	 	[**]	 	[**]	 	[**]
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	a.
	 	Initial review of completed Batch Record	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Final review / approval of completed
Batch Record	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Issuance/Approval of Certificate of
Conformance	 	 	 	 	 	 	 	 
	 

	 	d.
	 	Issuance/Approval of Certificate of
Analysis [**]	 	 	 	 	 	 	 	 
	PRODUCT RELEASE continued	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	e.
	 	Issuance of Certificate of Analysis [**]	 	 	 	 	 	 	 	 
	 

	 	f.
	 	Lot Release	 	 	 	 	 	 	 	 

 

 

Exhibit E

APPENDIX II

Summary of Responsibilities

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	RESPONSIBILITY
	 	 	 	 	 	 	Stage(s) of Manufacturing
	 	 	 	 	 	 	[**]	 	[**]
	Topic	 	Emergent	 	Talecris	 	Emergent	 	Talecris
	NON-CONFORMANCE EVENTS	 	[**]	 	[**]	 	[**]	 	[**]
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Deviations	 	 	 	 	 	 	 	 
	 

	 	a.
	 	Documentation of non-conformance event
per established SOP’s	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Notification to Emergent of
non-conforming event [**]	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Investigation of non-conforming event
and identifying appropriate CAPA’s	 	 	 	 	 	 	 	 
	 

	 	d.
	 	Approval of non-conforming event [**]	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	OOS – Assays performed by Talecris [**]	 	 	 	 	 	 	 	 
	 

	 	e.
	 	Documentation of OOS per established
SOP’s	 	 	 	 	 	 	 	 
	 

	 	f.
	 	Notification to Emergent of confirmed
OOS event with established root cause	 	 	 	 	 	 	 	 
	 

	 	g.
	 	Review of confirmed OOS and retest plan
with established root cause	 	 	 	 	 	 	 	 
	 

	 	h.
	 	Investigation of OOS event and
identification of appropriate CAPA’s
including proposed re-test plans	 	 	 	 	 	 	 	 
	 

	 	i.
	 	Review of confirmed OOS event and
re-test plan where no assignable root
cause is established	 	 	 	 	 	 	 	 
	 

	 	j.
	 	Approval of confirmed OOS event and
re-test plan where no assignable root
cause is established	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	OOS – Assays performed by Emergent [**]	 	 	 	 	 	 	 	 
	 

	 	k.
	 	Documentation of OOS per established
SOP’s	 	 	 	 	 	 	 	 
	 

	 	l.
	 	Notification to Talecris of confirmed
OOS event	 	 	 	 	 	 	 	 
	 

	 	m.
	 	Investigation of OOS event and
identification of appropriate CAPA’s
including proposed re-test plans	 	 	 	 	 	 	 	 

 

 

Exhibit E

APPENDIX II

Summary of Responsibilities

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	RESPONSIBILITY
	 	 	 	 	 	 	Stage(s) of Manufacturing
	 	 	 	 	 	 	[**]	 	[**]
	Topic	 	Emergent	 	Talecris	 	Emergent	 	Talecris
	 

	 	n.
	 	Approval of OOS event and re-test plan	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	AUDITING / MAN-IN-PLANT	 	[**]	 	 	 	[**]	 	[**]
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	a.
	 	Right to conduct scheduled routine
audits of facility and quality systems not
to exceed one (1) occurrence per year	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Right to conduct “for cause” audits of
facility and quality systems as needed in
response to specific noncompliance events
[**]	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Right to maintain “man-in-plant”
presence during process start up and
execution of validation lots	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	ADVERSE EVENTS / PRODUCT COMPLAINTS	 	[**]	 	[**]	 	[**]	 	[**]
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	a.
	 	Regulatory notification of AE’s
Complaints as required by regulations	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Lead in AE / Complaint investigations	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Assistance in conducting AE / Complaint
investigations, including manufacturing
investigation	 	 	 	 	 	 	 	 
	 

	 	d.
	 	Final written report for AE / Complaints	 	 	 	 	 	 	 	 
	 

	 	e.
	 	Approval of report	 	 	 	 	 	 	 	 

 

 

Exhibit E

APPENDIX II

Summary of Responsibilities

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	RESPONSIBILITY
	 	 	 	 	 	 	Stage(s) of Manufacturing
	 	 	 	 	 	 	[**]	 	[**]
	Topic	 	Emergent	 	Talecris	 	Emergent	 	Talecris
	PRODUCT RECALL	 	[**]	 	[**]	 	[**]	 	[**]
	 

	 	a.
	 	Final Decision – [**]	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Notification of other Company regarding
recall decision	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Notification of potential event that
may initiate recall	 	 	 	 	 	 	 	 
	 

	 	d.
	 	Impact of recall on Talecris filings	 	 	 	 	 	 	 	 
	 

	 	e.
	 	Impact of recall on Emergent filings	 	 	 	 	 	 	 	 
	 

	 	f.
	 	FDA notification of recall	 	 	 	 	 	 	 	 
	 

	 	g.
	 	Management of recall event	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	“LOOK BACK” PROCESS	 	[**]	 	[**]	 	[**]	 	[**]
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	a.
	 	Plasma collection center notification

for look backs involving units at Talecris	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Tracing of plasma units effected by
look back	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Destruction of plasma units not yet
processed and documentation of destruction	 	 	 	 	 	 	 	 
	 

	 	d.
	 	Supplying documentation of plasma unit
destruction to Emergent	 	 	 	 	 	 	 	 
	 

	 	e.
	 	Product impact assessment involving
plasma units that have been processed	 	 	 	 	 	 	 	 
	 

	 	f.
	 	Supply copies of documentation to
include plasma pool date and product lot
number(s) for processed/pooled plasma	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	REGULATORY	 	[**]	 	[**]	 	[**]	 	[**]
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	a.
	 	Single IND Submission by Emergent
for AIG Product	 	 	 	 	 	 	 	 
	 

	 	b.
	 	BLA Submission	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Notification of any regulatory action
which could affect finished product	 	 	 	 	 	 	 	 
	 

	 	d.
	 	Providing regulatory advice as needed
related to process related to Emergent
filings	 	 	 	 	 	 	 	 
	 

	 	e.
	 	Communications to Regulatory
Authorities concerning Finished Product	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 

 

 

Exhibit E

APPENDIX II

Summary of Responsibilities

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	RESPONSIBILITY
	 	 	 	 	 	 	Stage(s) of Manufacturing
	 	 	 	 	 	 	[**]	 	[**]
	Topic	 	Emergent	 	Talecris	 	Emergent	 	Talecris
	REGULATORY INSPECTIONS	 	[**]	 	[**]	 	[**]	 	[**]
	 

	 	a.
	 	Notification of regulatory inspection
by FDA, EU Regulatory agency or other
governmental agency in conjunction with
the facilities, processes or quality
systems used to manufacture or support
Emergent finished product.	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Ability to maintain site presence
during inspection [**]	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Approval of corrective actions
associated with identified deficiencies or
observations resulting from inspections
[**]	 	 	 	 	 	 	 	 
	 

	 	d.
	 	Review and approval of corrective
actions associated with identified
deficiencies or observations resulting
from inspections [**]	 	 	 	 	 	 	 	 
	 

	 	e.
	 	Submission of
corrective actions to inspecting Authority	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	BIOLOGICAL PRODUCT DEVIATIONS	 	[**]	 	[**]	 	[**]	 	[**]
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	a.
	 	Final Decision – submission of BPDR
related to distributed product	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Submission of BPDR	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Lead – investigation for BPDR	 	 	 	 	 	 	 	 
	 

	 	d.
	 	Assistance – investigation including
manufacturing investigation	 	 	 	 	 	 	 	 

 

 

Exhibit E

APPENDIX II

Summary of Responsibilities

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	RESPONSIBILITY
	 	 	 	 	 	 	Stage(s) of Manufacturing
	 	 	 	 	 	 	[**]	 	[**]
	Topic	 	Emergent	 	Talecris	 	Emergent	 	Talecris
	 
	CHANGE MANAGEMENT	 	[**]	 	[**]	 	[**]	 	[**]
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Talecris Initiated	 	 	 	 	 	 	 	 
	 

	 	a.
	 	Approval of changes to facility
or Gamunex process, including
testing and specifications , that do
not impact [**]	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Notification of non-routine
changes to facility or Gamunex
process, including testing and
specifications, that have the
potential to impact [**]	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Review and approval of
non-routine changes to facility or
Gamunex process, including testing
and specifications, that have the
potential to impact [**]	 	 	 	 	 	 	 	 
	 

	 	d.
	 	Review of changes to facility or
Gamunex process, including testing
and specifications, required to
maintain compliance to GMP during
audit(s)	 	 	 	 	 	 	 	 
	 

	 	e.
	 	Approval of changes to facility
or Gamunex process, including
testing and specifications, required
to maintain GMP	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Emergent Initiated	 	 	 	 	 	 	 	 
	 

	 	f.
	 	Approval of changes to process
including specifications that do not
impact facilities or Gamunex process	 	 	 	 	 	 	 	 
	 

	 	g.
	 	Notification of changes to
process including specifications
that have the potential to impact
facilities or Gamunex process	 	 	 	 	 	 	 	 
	 

	 	h.
	 	Approval of changes to process
including specifications that have
the potential to impact facilities
or Gamunex process	 	 	 	 	 	 	 	 

 

 

Exhibit E

APPENDIX II

Summary of Responsibilities

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	RESPONSIBILITY
	 	 	 	 	 	 	Stage(s) of Manufacturing
	 	 	 	 	 	 	[**]	 	[**]
	Topic	 	Emergent	 	Talecris	 	Emergent	 	Talecris
	 
	VALIDATION	 	[**]	 	[**]	 	[**]	 	[**]
	 

	 	a.
	 	Maintaining validated state of
facility and equipment used for
Gamunex [**]	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Writing Process Validation
Protocol	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Approval of Process Validation
Protocol	 	 	 	 	 	 	 	 
	 

	 	d.
	 	Writing Process Validation Report	 	 	 	 	 	 	 	 
	 

	 	e.
	 	Approving Process Validation
Report	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	ANNUAL PRODUCT REVIEW / ANNUAL REPORT	 	 	 	[**]	 	 [**]	 	 [**]
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	a.
	 	Preparation of summary data for
Emergent Annual Product Review
Report	 	 	 	 	 	 	 	 
	 

	 	b.
	 	Annual Product Review final report	 	 	 	 	 	 	 	 
	 

	 	c.
	 	Submission of Annual Report to FDA	 	 	 	 	 	 	 	 

 

 

EXHIBIT
F

	 	 	 
	protected by

	 	

QUALITY AGREEMENT

Emergent Product Development Gaithersburg Inc.

300 Professional Drive

Gaithersburg, MD 20879

(Hereafter called “Emergent”)

AND

Talecris Biotherapeutics, Inc.

4101 Research Commons/79 T.W. Alexander Drive

Research Triangle Park, NC 27709

(Hereafter called “Talecris”)

	 	 	 	 	 
	Approved by:

	 	 	 	Date:
	 
	 	 	 	 
	     /s/ Edward Arcuri
 

	 	 	 	7/31/06 
	Emergent BioSolutions Inc.
	 	 	 	 
	Edward Arcuri
	 	 	 	 
	Executive Vice President, Corporate Operations
	 	 	 	 
	Chief Operating Officer
	 	 	 	 
	 
	 	 	 	 
	     /s/ Barbara Sneade
 

	 	 	 	7/31/06 
	Talecris Biotherapeutics Inc.
	 	 	 	 
	Barbara Sneade
	 	 	 	 
	Senior Quality Manager, Quality Operations
	 	 	 	 

 

 

History of Revisions

	 	 	 	 	 	 	 
	Version	 	Date	 	Revised By	 	Description
	01

	 	July 27 2006
	 	D. Bland
	 	New
	 
	 	 	 	 	 	 

					
	 	 	 	 	 
	Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc. 

Quality Agreement	 	Emergent BioSolutions
	 	 	 	 	 
	CONFIDENTIAL
	 	Version 01
	 	Page 2 of 27

 

 

TABLE OF CONTENTS

	 	 	 	 	 
	 	 	Page	 
	1. DEFINITIONS
	 	 	4	 
	 
	2. SCOPE / GENERAL REGULATORY COMPLIANCE
	 	 	4	 
	 
	3. PURPOSE
	 	 	5	 
	 
	4. CONTACT INFORMATION
	 	 	5	 
	 
	5. DURATION OF AGREEMENT
	 	 	5	 
	 
	6. MANUFACTURING cGMP COMPLIANCE
	 	 	5	 
	 
	7. QUALITY CONTROL
	 	 	9	 
	 
	8. QUALITY ASSURANCE
	 	 	11	 
	 
	9. REGULATORY COMPLIANCE
	 	 	14	 
	 
	10. DISPUTE RESOLUTION
	 	 	16	 
	 
	11. CHANGE MANAGEMENT
	 	 	17	 
	 
	12. PRODUCT AND PROCESS VALIDATION
	 	 	17	 
	 
	13. NOTIFICATION OF NEW PRODUCT CLASSIFICATION
	 	 	18	 
	 
	14. ANNUAL PRODUCT REVIEW, ANNUAL REPORT AND DRUG LISTING
	 	 	18	 
	 
	APPENDIX I — List of Contacts
	 	 	19	 
	 
	APPENDIX II — Summary of Responsibilities
	 	 	21	 

					
	 	 	 	 	 
	Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc. 

Quality Agreement	 	Emergent BioSolutions
	 	 	 	 	 
	CONFIDENTIAL
	 	Version 01
	 	Page 3 of 27

 

 

1. DEFINITIONS

	 	1.1	 	The definitions set forth in the Product Supply Agreement are applicable to this Quality Agreement.

2. SCOPE / GENERAL REGULATORY COMPLIANCE

	 	2.1	 	This Quality Agreement is between Emergent and Talecris and applies to Finished
Product manufactured with the intent to support Investigational New Drug (IND)
applications, Biological License Applications (BLA) and Commercial Product as set forth
in the Product Supply Agreement.

	 	2.1.1.	 	[**].
	 
	 	2.1.2.	 	[**].

	 	2.2	 	In the event of amendments or changes to the Product Supply Agreement, or at
intervals not to exceed 1 (one) year, the Quality Agreement will be reviewed by
Emergent and Talecris to ensure that the roles and responsibilities reflect current
practice and can be modified as needed with the written approval of both parties.
	 
	 	2.3	 	For the avoidance of doubt the arrangements relating to the manufacture of
Finished Product are governed by the Product Supply Agreement and subsequent
amendments. In the event of any inconsistency between the terms and conditions of this
Quality Agreement and the terms and conditions of the Product Supply Agreement and
possible subsequent amendments between the parties, the terms and conditions of the
Product Supply Agreement and the subsequent amendments shall prevail.
	 
	 	2.4	 	Emergent and Talecris shall conduct operations in compliance with cGMP as
defined in applicable sections of 21 CFR (see definitions). Both parties agree to work
together in good faith to resolve differences in interpretation of current issues of
these regulations and guidelines.
	 
	 	2.5	 	Emergent and Talecris shall ensure that the receipt, manufacture, labeling,
packaging, testing, release, storage and shipping of the Finished Product are in
compliance with the above noted regulations and associated guidelines or equivalent
standards.

					
	 	 	 	 	 
	Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc. 

Quality Agreement	 	Emergent BioSolutions
	 	 	 	 	 
	CONFIDENTIAL
	 	Version 01
	 	Page 4 of 27

 

 

3. PURPOSE

	 	3.1	 	This Quality Agreement further defines the roles and responsibilities for the
Emergent and Talecris Quality Departments for the services defined in the Product
Supply Agreement. A summary of responsibilities is presented in Appendix II of this
Quality Agreement.
	 
	 	3.2	 	This Quality Agreement also defines how Talecris Quality Departments and
Emergent Quality Departments will interact during conduct of contracted services.
	 
	 	3.3	 	This Quality Agreement shall be considered an Exhibit to the Product Supply
Agreement. Refer to Section 2.3 in the event of discrepancies between the Quality
Agreement and Product Supply Agreement.

4. CONTACT INFORMATION

	 	4.1	 	Emergent contact names: refer to Appendix I
	 
	 	4.2	 	Talecris contact names: refer to Appendix I

5. DURATION OF AGREEMENT

	 	5.1	 	The Quality Agreement will be effective once representatives of Emergent and
Talecris approve the document as designated by the signatures and date on the cover
page of the Quality Agreement and will expire with termination or expiration of the
Product Supply Agreement and any subsequent amendments except for provisions which, by
their nature, are intended to survive.

6. MANUFACTURING cGMP COMPLIANCE

	 	6.1	 	General

	 	6.1.1.	 	The manufacturing operations for the Finished Product to be performed by
Talecris are defined in the Product Supply Agreement.

	 	6.2	 	Premises

	 	6.2.1.	 	Talecris will manufacture the Finished Product at the Clayton facility. The
floor plans of the manufacturing areas and corresponding room classifications
will be made available by Talecris for review by Emergent during annual audits
of the facility by Emergent.
	 
	 	6.2.2.	 	The premises and equipment used to manufacture Finished Product will be
maintained according to current regulatory requirements and in accordance with
the approved procedures. The production of the Finished Product will be
conducted in a suitably controlled environment and such facilities will be
regularly monitored for parameters critical to the process to demonstrate
compliance with appropriate cGMP and Regulatory Guidelines.
	 
	 	6.2.3.	 	Talecris will maintain controlled access to the premises.

					
	 	 	 	 	 
	Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc. 

Quality Agreement	 	Emergent BioSolutions
	 	 	 	 	 
	CONFIDENTIAL
	 	Version 01
	 	Page 5 of 27

 

 

6.3 cGMP

	 	6.3.1.	 	The principles detailed in the referenced documents in Section 2 of this
Quality Agreement will cover the standards of manufacture of the Finished
Product. Applicable cGMP guidelines will cover the standards of quality
assurance for the Finished Product.

6.4 Materials

	 	6.4.1.	 	For pooling of [**] plasma (source plasma), purification, and manufacture of
the [**], Talecris will use only raw materials and components listed in the
Bill of Materials or Master Production Records.
	 
	 	6.4.2.	 	For manufacture of the [**] and Finished Product, packaging, and labeling
activities, Talecris will use only packaging materials and labeling components
listed in the Bill of Materials or Master Production Records, which have been
reviewed and approved by Emergent.
	 
	 	6.4.3.	 	Materials Procured by Talecris

	 	6.4.3.1.	 	Talecris is responsible for ensuring that all materials and
components procured by Talecris for use in the manufacture of Finished
Product are in full compliance with the approved specifications.
	 
	 	6.4.3.2.	 	Talecris is responsible for ensuring that all materials are
appropriately sampled, tested, and stored upon receipt, and that only
released raw materials are used in the manufacture of Finished Product,
as well as for holding the relevant Certificates of Analysis for the
raw materials.
	 
	 	6.4.3.3.	 	Talecris is responsible for ensuring all Finished Product related
vendors and suppliers for materials procured by Talecris for the
manufacture of Finished Product are approved for use by Talecris
Quality.

	 	6.4.4.	 	Materials Provided by Emergent for Talecris – AIG Source Plasma

	 	6.4.4.1.	 	Emergent is responsible for ensuring that the AIG Source Plasma
collected on behalf of Emergent and provided to Talecris by Emergent
for use in the manufacture of Finished Product meets the requirements
of the AIG Source Plasma Specifications, Talecris General Plasma
Specification, and Plasma Supplier Supplemental Directions current
revision.
	 
	 	6.4.4.2.	 	Emergent Quality is responsible for ensuring all vendors and
suppliers related to the supply of AIG Source Plasma are approved for
use by Emergent Quality.
	 
	 	6.4.4.3.	 	Talecris Quality is responsible for ensuring that all plasma
centers supplying AIG Source Plasma are approved and are listed on the
Talecris approved sources list.

					
	 	 	 	 	 
	Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc. 

Quality Agreement	 	Emergent BioSolutions
	 	 	 	 	 
	CONFIDENTIAL
	 	Version 01
	 	Page 6 of 27

 

 

	 	6.5	 	Master Production Records

	 	6.5.1.	 	Talecris will create and maintain the manufacturing information in the form
of a Master Production Record (MPR) in accordance with their established
procedures and policies.

	 	6.5.1.1.	 	MPR’s for the manufacture of the [**] will be reviewed by Emergent
[**] prior to initiation of the first production campaign.
	 
	 	6.5.1.2.	 	MPR’s for manufacture of the [**] and Finished Product (filled,
packaged, labeled) will be reviewed and approved by Emergent [**] prior
to the first manufacture of the [**] and Finished Product.

	 	6.5.2.	 	Changes to approved MPR’s will be documented and justified according to
established [**] as outlined in the Change Management section of this
Agreement (refer to Section 11).

	 	6.6	 	Standard Operating Procedures

	 	6.6.1.	 	Talecris shall maintain the Standard Operating Procedures (SOP’s) and/or Test
Methods required to manufacture, test, and store the Finished Product [**] with
the exception of the testing of the [**].

	 	6.6.1.1.	 	Emergent will review Standard Operating Procedures and/or Test
Methods created exclusively for the manufacture of Finished Product.

	 	6.6.2.	 	Changes to approved SOP’s and/or Test Methods will be documented and
justified according to established [**] as outlined in the Change Management
section of this Agreement (see Section 11).

	 	6.7	 	Batch Numbers

	 	6.7.1.	 	Talecris will determine the manufacturing batch numbering system for raw
materials and components used in the manufacture of Finished Product in
accordance to their established procedures and policies. Each lot of Bulk Drug
Substance and Final Drug Product will have unique identifiers assigned and
recorded.
	 
	 	6.7.2.	 	Talecris will be responsible for maintaining forward and backward lot
traceability for all components and raw materials used in the manufacture of
Finished Product.

	 	6.8	 	Dates of Manufacture and Expiration

	 	6.8.1.	 	Date of Manufacture- Talecris will assign the Date of Manufacture in
accordance to their established procedures and policies. Dates of Manufacture
will be assigned to the Bulk Drug Substance and Final Drug Product. Date of
Manufacture will not be assigned to in-process hold steps.
	 
	 	6.8.2.	 	Expiration Date: Talecris will assign an Expiration Date for the Bulk Drug
Substance in accordance with established procedures and policies.

					
	 	 	 	 	 
	Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc. 

Quality Agreement	 	Emergent BioSolutions
	 	 	 	 	 
	CONFIDENTIAL
	 	Version 01
	 	Page 7 of 27

 

 

	 	 	 	Expiration dates will be assigned to in-process hold steps per Talecris.
Expiration dating and/or shelf-life period for Final Drug Product will be
established by Emergent.

	 	6.9	 	Manufacturing and Equipment Data

	 	6.9.1.	 	Talecris is responsible for keeping records of equipment usage, cleaning, and
any maintenance and calibration performed according to cGMP requirements.
	 
	 	6.9.2.	 	As applicable, Talecris is responsible for labeling all non-disposable
Finished Product dedicated equipment and storing this equipment appropriately
to prevent its use and or cross contamination with other products.
	 
	 	6.9.3.	 	Talecris is responsible for having adequate cleaning validation for all
non-disposable non-dedicated equipment used in the manufacture of Finished
Product.
	 
	 	6.9.4.	 	Talecris is responsible for having adequate room clearance procedures,
including decontamination procedures appropriate for the degree of exposure of
the Finished Product for all non-dedicated rooms in which the Finished Product
is manufactured.

	 	6.10	 	Reprocessing and Rework

	 	6.10.1.	 	Reprocessing and rework at any stage of the manufacture of Finished Product,
including re-labeling, will be according to Talecris and Emergent license and
process validation.
	 
	 	6.10.2.	 	Documentation of re-labeling or re-inspection will be included in the
production batch record documentation submitted to Emergent.

	 	6.11	 	Storage and Shipment

	 	6.11.1.	 	Talecris will store Finished Product under conditions as specified in
approved specifications and the Product Supply Agreement.
	 
	 	6.11.2.	 	Talecris will ensure that during storage of the Finished Product at Talecris
appropriate cGMP controls are in place to prevent interference, theft, product
contamination, or admixture with any other materials.

	 	6.12	 	Finished Product will be suitably packaged and labeled for transit. Emergent
shall specify the design and content of the package insert and labels in accordance
with Talecris’ equipment limitations. At the request of Emergent, Talecris shall work
with Emergent to specify the design of the labels and insert.

	 	6.12.1.	 	Emergent will authorize Talecris to ship Finished Product in writing.
Samples associated with the manufacture of Finished Product required for
testing or other purposes may be shipped prior to the Finished Product.
	 
	 	6.12.2.	 	Talecris will prepare shipments of Finished Product as directed by Emergent
using shipping containers, temperature controls and recorders as determined
appropriate by Emergent.

					
	 	 	 	 	 
	Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc. 

Quality Agreement	 	Emergent BioSolutions
	 	 	 	 	 
	CONFIDENTIAL
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7. QUALITY CONTROL

	 	7.1	 	General

	 	7.1.1.	 	The testing activities for Finished Product that are to be performed by
Talecris are to be performed in accordance with approved Test Methods and SOP’s
and according to established specifications.
	 
	 	7.1.2.	 	Talecris will notify Emergent and obtain prior approval for the sub-contract
of any analytical testing related to the manufacture of Finished Product.

	 	7.2	 	Materials supplied by Talecris

	 	7.2.1.	 	Quality control of materials supplied by Talecris will be performed by Talecris.
	 
	 	7.2.2.	 	Talecris will notify Emergent of any significant Quality Assurance
non-conformance investigations related to the testing, storage and handling of
any raw materials used to manufacture Finished Product as defined in Section
8.2.

	 	7.3	 	In-Process and Final Drug Product Testing

	 	7.3.1.	 	Talecris will perform testing on in-process samples, [**] plasma, bulk drug
substance and final drug product as agreed upon by Talecris and Emergent, using
approved specifications, SOP’s and/or Test methods.
	 
	 	7.3.2.	 	Emergent will perform product-specific testing on in-process samples, [**]
plasma, bulk drug substance and final drug product as agreed upon by Talecris
and Emergent, using approved specifications, SOP’s and/or Test methods.
	 
	 	7.3.3.	 	In-Process and [**] plasma test results generated by Talecris and Emergent
will be documented either in the executed MPR or separately on a document that
will be included with the MPR.
	 
	 	7.3.4.	 	For each lot of [**] manufactured for and Final Drug Product delivered to
Emergent, Talecris will provide to Emergent a Certificate of Conformance (CofC)
to confirm each lot has been manufactured per approved procedures and in
conformance with appropriate cGMP requirements. At a minimum, the CofC will
contain the following information:

	 	Ø    	 	Product/Lot description/name
	 
	 	Ø    	 	Lot number
	 
	 	Ø    	 	Date of Manufacture
	 
	 	Ø    	 	Expiration Date
	 
	 	Ø    	 	Quantity/Dose/Volume
	 
	 	Ø    	 	Storage conditions
	 
	 	Ø    	 	Declaration that the product was manufactured in compliance with GMP regulations
	 
	 	Ø    	 	Signature/Date of a responsible Quality representative

	 	7.3.5.	 	For each lot of [**] and Final Drug Product delivered to Emergent, Talecris
will provide a Certificate of Analysis (CofA) to confirm each lot has been

					
	 	 	 	 	 
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	 	 	 	tested in accordance with and has met the approved Specifications. At a
minimum, the CofA will contain the following information:

	 	Ø    	 	Product/Lot description/name
	 
	 	Ø    	 	Lot number
	 
	 	Ø    	 	Test method name
	 
	 	Ø    	 	Corresponding test method procedure number
	 
	 	Ø    	 	Test method acceptance criteria as applicable (e.g. specific
value(s), range of values, or pass/fail)
	 
	 	Ø    	 	Actual test result
	 
	 	Ø    	 	An indication of whether the actual test result represents a “Pass”
or “Fail” result when compared to the test method acceptance criteria.
	 
	 	Ø    	 	Attestation of lot conformance to release specifications
	 
	 	Ø    	 	Signature/Date of a responsible Quality representative

	 	7.3.6.	 	All In-Process and Release Testing results are to be reviewed and approved by
the appropriate Talecris Quality Management.

	 	7.4	 	Retain Samples

	 	7.4.1.	 	Talecris is responsible for storing retain samples of the Bulk Drug Substance
and Final Drug Product per 21 CFR Part 211.170.

	 	7.5	 	Stability Testing

	 	7.5.1.	 	Talecris is responsible for conducting stability studies on the Finished
Product, and identifying the batch number and quantity of samples for the lots
to be tested.
	 
	 	7.5.2.	 	Stability protocols will be generated by Talecris and approved by Talecris
and Emergent.
	 
	 	7.5.3.	 	Stability reports will be generated by Talecris and approved by Talecris and
Emergent. Emergent will be responsible for any required action as a result of
the stability data.

	 	7.6	 	Out-of-Specification (OOS) Investigations

	 	7.6.1.	 	Talecris is responsible for investigating any in-process or Finished Product
testing performed by Talecris that fails to meet approved specifications.
Talecris will notify a designated Emergent Quality representative per the
requirements for notification of deviations as outlined in Section 8.1.

	 	7.6.1.1.	 	Each OOS investigation will be reviewed by Talecris designated
Quality representative(s), and will follow the procedures defined in
appropriate Talecris SOPs for OOS Investigations.
	 
	 	7.6.1.2.	 	For each confirmed Finished Product OOS result in which the
investigation has not determined a root cause, Emergent will be allowed
to review the investigation and approve the proposed re-test plan prior
to any re-testing being performed.
	 
	 	7.6.1.3.	 	For each OOS result in which the investigation has determined a
root cause, Emergent reserves the right to review the

					
	 	 	 	 	 
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	 	 	 	investigation and will be notified by Talecris of the intent to
re-test prior to any re-testing being performed.

	 	7.6.2.	 	Emergent is responsible for investigating any in-process or Finished Product
testing performed by Emergent that fails to meet approved specifications.
Emergent will notify a designated Talecris Quality representative per the
requirements for notification of deviations as outlined in Section 8.1.

	 	7.6.2.1.	 	Each OOS investigation will be reviewed by Emergent designated
Quality representative(s), and will follow the procedures defined in
appropriate Emergent SOPs for OOS Investigations.

	 	7.6.3.	 	Talecris shall retain final authority for the content of investigation
reports for testing performed by Talecris and directly related to the [**]
manufacture.
	 
	 	7.6.4.	 	Emergent shall retain final authority for the content of investigation
reports for product-specific testing performed by Emergent for all stages of
manufacture.
	 
	 	7.6.5.	 	Copies of all completed investigation reports will be included in the
released, executed production batch record documentation provided to Emergent.

8. QUALITY ASSURANCE

	 	8.1	 	Deviations and Investigations

	 	8.1.1.	 	Deviation and Investigation Reports – Any deviation from the process during
manufacture, including but not limited to, batch record execution,
environmental monitoring excursions or aseptic processing procedures, must be
documented and investigated per Talecris approved procedures for conducting
non-conformance investigations.

	 	8.1.1.1.	 	All non-conformance investigations will include an explanation of
the non-conformance event, root cause analysis, impact assessment and
corrective/preventive actions.
	 
	 	8.1.1.2.	 	All non-conformance investigations directly related to the
manufacture of Finished Product must be approved by Talecris Quality
and the affected area management, and be included in the released,
executed production batch record.
	 
	 	8.1.1.3.	 	Any non-conformance event which has the potential to impact the
safety, identity, strength, purity, or quality of the Finished Product
will be communicated to Emergent Quality not more than [**] working
days after discovery.
	 
	 	8.1.1.4.	 	Emergent Quality will have the right to participate in and approve
any investigation associated with a non-conformance event which has the
potential to impact the safety, identity, strength, purity, or quality
of the Finished Product.

					
	 	 	 	 	 
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	 	8.1.2.	 	Talecris will provide notification to Emergent and investigate any adverse
trends, including review of media fills and environmental monitoring data,
which may directly impact Finished Product, either in process or that has
previously shipped to Emergent, within [**] working days of initiation of the
investigation.

	 	8.2	 	Batch Disposition Documentation

	 	8.2.1.	 	Talecris is responsible for the review and final approval of the executed
batch record(s) associated with [**].
	 
	 	8.2.2.	 	For each lot of [**] manufactured by Talecris for Emergent, Talecris will
provide Emergent with the following documentation:

	 	Ø    	 	Certificate of Conformance
	 
	 	Ø    	 	Certificate of Analysis (excluding testing performed by Emergent)
	 
	 	Ø    	 	A summary of non-conformances (i.e. deviation and/or OOS)
	 
	 	Ø    	 	Copies of any non-conformances that have been determined to have
potential impact on the safety, identity, strength, purity, or quality
of the [**]
	 
	 	Ø    	 	Lot Release Certificate signed by Talecris Quality

	 	8.2.3.	 	Prior to shipment, Talecris is responsible for the review and approval of the
executed batch production record(s) associated with each lot of Finished
Product manufactured for Emergent.
	 
	 	8.2.4.	 	For each lot of Finished Product manufactured for Emergent, Talecris will
provide Emergent with the following documentation:

	 	Ø    	 	A copy of the product-specific executed production batch record(s),
from the [**] forward, reviewed and approved by Talecris Quality
	 
	 	Ø    	 	Certificate of Conformance
	 
	 	Ø    	 	Certificate of Analysis (excluding testing performed by [**])
	 
	 	Ø    	 	A summary of non-conformances (i.e., deviation and/or OOS)
	 
	 	Ø    	 	Copies of any non-conformances which have been determined to have
potential impact on the safety, identity, strength, purity, or quality
of the Finished Product

	 	8.2.5.	 	Emergent must authorize in writing [**] any lot of Finished Product [**] by
Talecris prior to its disposition.

	 	8.3	 	Product [**]

	 	8.3.1.	 	[**] is the sole responsibility of Talecris.
	 
	 	8.3.2.	 	[**] is the sole responsibility of Emergent.
	 
	 	8.3.3.	 	Any issue(s) discovered by Emergent associated with production batch record
documentation, disposition documentation or samples provided to Emergent by
Talecris that may impact or prevent the final release of the Finished Product,
or that has the potential to cause the rejection of Finished Product by
Emergent, will be communicated to Talecris by Emergent within [**] of
discovery. Talecris is responsible for working with

					
	 	 	 	 	 
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	 	 	 	Emergent in the conduct of any additional investigations that may be
warranted to resolve the issue(s).

	 	8.4	 	Records Retention

	 	8.4.1.	 	Talecris will retain production batch records for all stages of the
manufacture of Finished Product for a minimum of at least one (1) year after
the expiration date of corresponding lot of Finished Product or for such longer
period as may be required by applicable law.
	 
	 	8.4.2.	 	Talecris will not destroy any batch production records or associated
documentation without obtaining written approval from Emergent prior to
destruction.

	 	8.5	 	Manufacturing and Quality Presence in the Manufacturing Facility

	 	8.5.1.	 	Talecris will maintain adequate, qualified Manufacturing and Quality
personnel to ensure compliance with cGMP and the consistent manufacture of
Finished Product.
	 
	 	8.5.2.	 	Talecris will permit Emergent representatives to be present at the facility
during the manufacture of Finished Product for observational purposes only.
This presence will be limited to the manufacture of the initial Validation
Lots. These visits will be pre-arranged by mutual consent.

	 	8.6	 	Product Complaints

	 	8.6.1.	 	Emergent is responsible for receiving and [**].
	 
	 	8.6.2.	 	Emergent will notify Talecris within [**] of discovery of any complaints
potentially associated with [**]. This notification may include a request for
Talecris to initiate [**].
	 
	 	8.6.3.	 	In the event [**] becomes aware of a complaint [**], including [**] will
notify [**] within [**] hours of becoming aware of the complaint.
	 
	 	8.6.4.	 	Talecris will initiate an [**] within [**] of an Emergent request, for any
complaint associated with [**] will be forwarded to Emergent Talecris within
thirty (30) calendar days of [**]. Extensions for the completion of the [**]
Talecris, along with justification for the extension and a proposed completion
date, within the initial thirty (30) calendar day period.

	 	8.7	 	Product Recalls

	 	8.7.1.	 	Emergent retains final decision making authority for product recalls associated with [**].
	 
	 	8.7.2.	 	Each party will notify the other party within [**] of (a) receipt of
notification, written or otherwise, if any lot of [**] is alleged or proven to
be the subject of a recall, market withdrawal or correction or (b) either
party’s determination that a recall may be warranted.
	 
	 	8.7.3.	 	Emergent is responsible for instituting a recall of [**]. Emergent will
notify Talecris of any recall decision within [**] of initiation if the recall
is associated with the manufacture of the [**].

					
	 	 	 	 	 
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	 	8.7.4.	 	[**] issued by Talecris associated with the [**] of the recall [**] will be
forwarded to Emergent within [**] after receipt of request. Extensions may be
requested by Talecris, with justification and a proposed completion date,
within the initial [**] period.

	 	8.8	 	Adverse Events

	 	8.8.1.	 	Emergent shall advise Talecris of any adverse medical event or adverse drug
event within [**] of Emergent receipt of notice thereof if thought to be due to
manufacture of Finished Product.
	 
	 	8.8.2.	 	Talecris will initiate an internal investigation within [**] of an Emergent
notification of any adverse medical event or adverse drug event potentially
associated with the manufacture of the Finished Product.
	 
	 	8.8.3.	 	Investigation reports will be forwarded to Emergent by Talecris within [**]
of initiation of the Talecris investigation. Extensions for the completion of
the investigation may be requested by Talecris, along with justification for
the extension and a proposed completion date, within the initial [**] period.

	 	8.9	 	Look-Back Process for AIG source plasma provided by Emergent to Talecris under
contract.

	 	8.9.1.	 	Emergent will arrange for the Plasma Collection Centers to notify Talecris
and Emergent directly in the event a look-back notification occurs.
	 
	 	8.9.2.	 	Talecris will investigate and act upon look-back notifications per approved
procedures and policies.
	 
	 	8.9.3.	 	For look back events affecting non-pooled [**], Talecris will provide
Emergent documentation of destruction of the units identified on the
notification (unit number/volume, donor number, date of destruction).
	 
	 	8.9.4.	 	For look back events affecting pooled/processed plasma, Talecris will provide
documentation to include the plasma pool date, associated product lot
number(s), and the corresponding product impact assessment.

9. REGULATORY COMPLIANCE

	 	9.1	 	Regulatory Inspections

	 	9.1.1.	 	Talecris will permit access by the Regulatory Authorities, as defined in the
Product Supply Agreement, to Talecris premises. Talecris will inform Emergent
of any announced regulatory inspections that involve the Finished Product
within [**], to permit Emergent to be present on site during the inspection.
	 
	 	9.1.2.	 	Talecris will immediately inform Emergent of any unannounced regulatory
inspections that involve the Finished Product. Talecris will permit an
Emergent representative to be present on site during the inspection involving
Finished Product.
	 
	 	9.1.3.	 	Talecris will secure the agreement of Emergent prior to making any commitment
to a Regulatory Authority specifically regarding Finished

					
	 	 	 	 	 
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	 	 	 	Product. Emergent shall be provided with draft responses to regulatory
observations that directly involve the Finished Product and may provide
comments to the responses and corrective actions within [**]. Emergent
shall retain the final authority and responsibility for the content of
responses directly related to Finished Product.
	 
	 	9.1.4.	 	Talecris will forward to Emergent any observations and associated responses
from a routine regulatory inspection directly related to Finished Product.
Talecris reserves the right to appropriately redact this documentation to
preserve client confidential information.
	 
	 	9.1.5.	 	Emergent will inform Talecris in writing of any regulatory issues that impact
Talecris’ ability to manufacture the Finished Product.

	 	9.2	 	Regulatory Actions

	 	9.2.1.	 	Talecris will notify Emergent in writing of any regulatory actions received
by Talecris related to the Finished Product or regulatory actions received by
Talecris that impact Talecris ability to manufacture the Finished Product.
	 
	 	9.2.2.	 	Emergent will notify Talecris in writing of any regulatory actions received
by Emergent related to the Finished Product or regulatory actions received by
Emergent that impact Talecris ability to manufacture the Finished Product.
	 
	 	9.2.3.	 	Talecris is responsible for supporting all investigations associated with
regulatory actions related to the manufacture of the Finished Product.

	 	9.3	 	Right to Audit

	 	9.3.1.	 	Talecris will permit Emergent to perform one standard cGMP compliance audit per year.

	 	9.3.1.1.	 	Talecris will allow representatives from Emergent to have access to
Talecris manufacturing, warehousing, laboratory premises, records,
regulatory filings and communications (i.e., FDA Form 483) directly
associated with the manufacture of Finished Product for audit purposes
provided, however, that Talecris has the obligation to protect the
confidential information of its clients.

	 	9.3.2.	 	Talecris will permit Emergent to conduct “for cause” audits to address
significant Finished Product quality or safety issues as discovered through
Finished Product failures or complaints and determined to be potentially
related to the manufacture of the Finished Product.

					
	 	 	 	 	 
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	 	9.4	 	Emergent may audit with the presence of Talecris any subcontractors that are
utilized by Talecris in the manufacture of the Finished Product. Talecris will use
reasonable efforts to cause such vendors, contractors or subcontractors to allow such
audits.
	 
	 	9.5	 	Audit Closeout

	 	9.5.1.	 	For audits of Talecris conducted by Emergent, an exit meeting will be held
with representatives from Talecris and Emergent to discuss audit observations.
	 
	 	9.5.2.	 	Emergent will provide a written report of all observations within thirty (30)
calendar days to Talecris. Within thirty (30) calendar days of the audit
report receipt, Talecris will provide a written response to all findings that
details corrective action to be implemented. Talecris will follow up to ensure
that all corrective actions are implemented.

10. DISPUTE RESOLUTION

	 	10.1	 	Non-Conformity of [**]

	 	10.1.1.	 	In the event that a dispute arises between Talecris and Emergent regarding
the conformity of a lot of [**], the resolution will proceed as follows:

	 	10.1.1.1.	 	Direct communication between the Quality units from both parties
will occur who will in good faith promptly attempt to reach an
agreement.
	 
	 	10.1.1.2.	 	If direct communication between the Quality units from both
parties does not resolve the dispute and Talecris Quality Unit
considers the disputed lot to be in conformance, Talecris Quality
retains sole authority over final disposition of the [**] lot; however
Emergent retains the right to reject the lot.

	 	10.2	 	Test Result Conflict

	 	10.2.1.	 	In the event that a dispute arises between Talecris and Emergent regarding
test results obtained during the manufacture and release of product lots, the
resolution will proceed as follows:

	 	10.2.1.1.	 	Talecris and Emergent will determine that the methods of analysis
are the same and are being executed in the same manner at both sites.
	 
	 	10.2.1.2.	 	If the investigation dictates, carefully controlled and split
samples shall be sent from one site to another in an attempt to reach
agreement.
	 
	 	10.2.1.3.	 	Analysts from both Talecris and Emergent shall be required to work
side by side through the analysis of a mutually agreeable sample.
	 
	 	10.2.1.4.	 	If resolution is not achieved after following the foregoing
procedure, the samples shall be sent to an independent,

					
	 	 	 	 	 
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	 	 	 	qualified testing laboratory agreed upon by both Talecris and
Emergent. Talecris and Emergent shall agree to be bound by the
results obtained by the independent laboratory.

11.  CHANGE MANAGEMENT

	 	11.1	 	Changes to the Process, Documents or Facility are to be processed using
Talecris approved Change Control procedures.

	 	11.1.1.	 	All proposed changes must document, at a minimum, the proposed change, the
reason/justification for the proposed change, the target date for
implementation of the proposed change, an impact assessment, and documentation
of pre- and post- validation or qualification requirements. The assessment of
impact must include an impact of the proposed change on any regulatory filings
and any required notification to regulatory authorities.

	 	11.2	 	Talecris shall not make any change to the Process, Documents or any Facility
(other than routine maintenance, reconditioning and/or replacement of the equipment)
that would reasonably be expected to have a negative impact on [**] or Finished Product
or require submissions to or approvals from any Regulatory Authority with respect to
the source plasma or Finished Product, except by prior written approval of Emergent.

	 	11.2.1.	 	Emergent will assess proposed changes requiring Emergent signature within
[**] and those changes marked urgent within [**].
	 
	 	11.2.2.	 	Completed change control documentation requiring Emergent approval shall be
included as part of the Production Batch Record documentation forwarded to
Emergent.
	 
	 	11.2.3.	 	Proposed changes initiated by Emergent must be approved by Talecris and
Emergent.

12. PRODUCT AND PROCESS VALIDATION

	 	12.1	 	Equipment and Process Validation– Talecris is responsible for ensuring that all
necessary equipment and process validations are conducted as required by cGMP and other
Regulatory Guidance Documents for the manufacture of Finished Product.
	 
	 	12.2	 	Cleaning Verification/Validation – Talecris is responsible for ensuring that
adequate cleaning of product contact parts used in the manufacture of Finished Product
is carried out between batches of different product to prevent cross contamination.
	 
	 	12.3	 	Sterilization and Depyrogenation Validation – Talecris is responsible for
ensuring that sterilization processes are validated and that adequate sterilization and
depyrogenation, as applicable, is carried out on the components and appropriate
equipment prior to the manufacture of each batch of Finished Product.
	 
	 	12.4	 	Equipment, Computer, Facility, and Utilities Qualification – Talecris is
responsible for ensuring that any equipment, computer, facility, utility and support
system used for the manufacture of Finished Product are qualified according to
applicable regulatory requirements.

					
	 	 	 	 	 
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	 	12.5	 	Assay Validation – Talecris is responsible for ensuring that all testing
performed by Talecris related to Finished Product is conducted using appropriately
validated assays. Emergent is responsible for ensuring that all testing performed by
Emergent related to Finished Product is conducted using appropriately validated assays.
	 
	 	12.6	 	For any test methods specifically for Finished Product conducted by a Third
Party laboratory contracted by Talecris, and approved by Emergent, Talecris is
responsible for ensuring the required validation work is performed.
	 
	 	12.7	 	For any test methods conducted by a Third Party laboratory contracted by
Emergent, Emergent is responsible for ensuring the required validation work is
performed. Talecris will have the right to audit such labs jointly with Emergent upon
request.
	 
	 	12.8	 	Packaging/Labeling/Shipping Qualification – Emergent is responsible for the
packaging configuration and shipping validation for Finished Product.

13. NOTIFICATION OF NEW PRODUCT CLASSIFICATION

	 	13.1	 	Talecris will notify Emergent [**] prior to introduction of a new product
classification into the production areas used for the manufacture of Finished Product.

14. ANNUAL PRODUCT REVIEW, ANNUAL REPORT AND DRUG LISTING

	 	14.1	 	Talecris will be responsible for providing reports as requested by Regulatory
Authorities under the “shared license agreement”.

	 	14.1.1.	 	Annual Product Review –On an annual calendar-year basis, Talecris will
prepare summary data for Finished Product processed within the prior calendar
year. Such data will be prepared and sent to Emergent within [**] (unless
otherwise agreed by Talecris and Emergent) of the end of the applicable
calendar year during which the Finished Product was Processed hereunder. This
data will include [**].
	 
	 	14.1.2.	 	Annual Report – Emergent is responsible for preparing any Annual Reports for
Investigational New Drugs and Licensed Product as required by applicable
regulations. At least [**] before the Annual Report due date, Emergent shall
request in writing from Talecris any information required by the regulations
that must be provided by Talecris, including but not limited to a summary of
any significant manufacturing or microbiological changes made during the past
reporting year. Talecris will provide the requested information to Emergent
within [**].

					
	 	 	 	 	 
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APPENDIX I – List of Contacts *

(Name, Phone, Fax, E-mail)

	 	 	 	 	 
	AREA OF RESPONSIBILITY

	 	Emergent BioSolutions Inc.
	 	Talecris Biotherapeutics, Inc.
	Product Development

	 	James McIver
	 	Deborah Barnette
	 

	 	Ph: (301) 944-0149
	 	Ph: (919)359-4601
	 

	 	Fax: (301) 590-1251
	 	Fax: (919)359-4280
	 

	 	McIverJ@ebsi.com
	 	deborah.barnette@talecris.com
	 
	 	 	 	 
	Manufacturing

	 	James McIver
	 	Jerry Sellers
	 

	 	Ph: (301) 944-0149
	 	Ph: (919)359-4533
	 

	 	Fax: (301) 590-1251
	 	Fax: (919)359-5462
	 

	 	MciverJ@ebsi.com
	 	jerry.sellers@talecris.com
	 
	 	 	 	 
	Quality Control

	 	Edward Arcuri
	 	Wayne Zunic
	 

	 	Ph: (301) 944-0109
	 	Ph: (919)359-4601
	 

	 	Fax: (301) 944-0173
	 	Fax: ( 919)359-4431
	 

	 	ArcuriE@ebsi.com
	 	wayne.zunic@talecris.com
	 
	 	 	 	 
	Audits

	 	Joy Dumont
	 	Barbara Sneade
	 

	 	Ph: (517) 327-1655
	 	Ph: (919)359-4415
	 

	 	Fax: (517) 327-7207
	 	Fax: (919)359-4677
	 

	 	DumontJ@ebsi.com
	 	barbara.sneade@talecris.com
	 
	 	 	 	 
	Validation

	 	Edward Arcuri
	 	Frank Highsmith
	 

	 	Ph: (301) 944-0109
	 	Ph: (919)359-7251
	 

	 	Fax: (301) 944-0173
	 	Fax: (919)359-4000
	 

	 	ArcuriE@ebsi.com
	 	frank.highsmith@talecris.com
	 
	 	 	 	 
	Regulatory

	 	Virginia Johnson
	 	Joan Robertson
	 

	 	Ph: (301) 944-0139
	 	Ph: (919)359-7128
	 

	 	Fax: (301) 590-1252
	 	Fax: (919)359-7154
	 

	 	JohnsonV@ebsi.com
	 	joan.robertson@talecris.com
	 
	 	 	 	 
	Product Complaints / Adverse Events

	 	Robert Hopkins
	 	Mary Ann Lamb
	 

	 	Ph: (301) 944-0136
	 	Ph: (919)359-7143
	 

	 	Fax: (301) 944-1252
	 	Fax: (919)359-7304
	 

	 	HopkinsR@ebsi.com
	 	maryann.lamb@talecris.com
	 
	 	 	 	 
	Quality Assurance

	 	Edward Arcuri
	 	John Parrish
	 

	 	Ph: (301) 944-0109
	 	Ph: (919)359-4592
	 

	 	Fax: (301) 944-0173
	 	Fax: (919)550-4886
	 

	 	ArcuriE@ebsi.com
	 	john.parrish@talecris.com

 

			
	*	 	All correspondence should be directed to David Sorrell of Talecris and Nili Leffers of Emergent

	 	 	 	 	 
	Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc.	 	Emergent BioSolutions
	Quality Agreement
	 	 	 	 
	 
	 	 	 	 
	CONFIDENTIAL

	 	Version 01
	 	Page 19 of 27

 

 

APPENDIX II

Summary of Responsibilities

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	RESPONSIBILITY
	 	 	Stage(s) of Manufacturing
	 	 	[**]	 	[**]
	Topic	 	Emergent	 	Talecris	 	Emergent	 	Talecris
	GENERAL COMPLIANCE / REGULATORY
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	a. License holder with respect to Shared
Manufacturing License process
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Compliance with US CFR / cGMP
regulations during manufacture
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	BATCH RECORDS
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	a. Write Master Production Records
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Review Master Production Records
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Approve Master Production Records
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	d. Approval of changes to Master Batch
Records that would have an effect on
product
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	e. Provide copies of approved Master
Production Records and executed Production
Batch Records
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	f. Record Retention (original documents –
Master Batch Records and executed Batch
Records)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	MATERIAL CONTROLS
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	a. Responsibility to ensure source AIG
plasma meets established plasma
specification
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Responsibility to ensure all components
and raw materials used in the manufacturing
process meet pre-approved specifications
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SUBCONTRACTING
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	a. Notification of intent/need to
subcontract
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Right to audit potential subcontractor
accompanied by Talecris
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Prior approval to initiate subcontracting
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	REPROCESSING / REWORK PER VALIDATED PROCEDURES
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	AND LICENSE
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	a. Rework according to Talecris and
Emergent approved license and validated
procedures
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	 	 	 	 
	Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc.	 	Emergent BioSolutions
	Quality Agreement
	 	 	 	 
	 
	 	 	 	 
	CONFIDENTIAL

	 	Version 01
	 	Page 20 of 27

 

 

APPENDIX II

Summary of Responsibilities

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	RESPONSIBILITY
	 	 	Stage(s) of Manufacturing
	 	 	[**]	 	[**]
	Topic	 	Emergent	 	Talecris	 	Emergent	 	Talecris
	SPECIFICATIONS
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	a. Product Specifications, [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Product Specification – [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Labeling and packaging components
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	d. Packaging inserts
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	e. Compatibility with equipment
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	STABILITY – Finished Product
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	a. Writing stability protocol
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Approving stability protocol
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Collection / storage of stability
samples
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	d. Testing – [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	e. Stability data interpretation – [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	f. Testing – [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	g. Writing stability report
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	h. Approving stability report
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	i. Establish expiration date/shelf life
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	PRODUCT RETAINS
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	a. Identification of samples to be retained
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Approval of samples to be retained
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Retention / storage of samples at
appropriate storage conditions
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	d. Final disposition of retain samples
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	PRODUCT RELEASE
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	a. Initial review of completed Batch Record
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Final review / approval of completed
Batch Record
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Issuance/Approval of Certificate of
Conformance
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	d. Issuance/Approval of Certificate of
Analysis [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	PRODUCT RELEASE continued
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	e. Issuance of Certificate of Analysis [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	f. Lot Release
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	 	 	 	 
	Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc.	 	Emergent BioSolutions
	Quality Agreement
	 	 	 	 
	 
	 	 	 	 
	CONFIDENTIAL

	 	Version 01
	 	Page 21 of 27

 

 

APPENDIX II

Summary of Responsibilities

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	RESPONSIBILITY
	 	 	Stage(s) of Manufacturing
	 	 	[**]	 	[**]
	Topic	 	Emergent	 	Talecris	 	Emergent	 	Talecris
	NON-CONFORMANCE EVENTS
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Deviations
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	a. Documentation of non-conformance event
per established SOP’s
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Notification to Emergent of
non-conforming event [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Investigation of non-conforming event
and identifying appropriate CAPA’s
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	d. Approval of non-conforming event [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	OOS – Assays performed by Talecris [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	e. Documentation of OOS per established
SOP’s
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	f. Notification to Emergent of confirmed
OOS event with established root cause
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	g. Review of confirmed OOS and retest plan
with established root cause
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	h. Investigation of OOS event and
identification of appropriate CAPA’s
including proposed re-test plans
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	i. Review of confirmed OOS event and
re-test plan where no assignable root
cause is established
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	j. Approval of confirmed OOS event and
re-test plan where no assignable root
cause is established
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	OOS – Assays performed by Emergent [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	k. Documentation of OOS per established
SOP’s
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	l. Notification to Talecris of confirmed
OOS event
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	m. Investigation of OOS event and
identification of appropriate CAPA’s
including proposed re-
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	 	 	 	 
	Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc.	 	Emergent BioSolutions
	Quality Agreement
	 	 	 	 
	 
	 	 	 	 
	CONFIDENTIAL

	 	Version 01
	 	Page 22 of 27

 

 

APPENDIX II

Summary of Responsibilities

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	RESPONSIBILITY
	 	 	Stage(s) of Manufacturing
	 	 	[**]	 	[**]
	Topic	 	Emergent	 	Talecris	 	Emergent	 	Talecris
	test plans
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	n. Approval of OOS event and re-test plan
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	AUDITING / MAN-IN-PLANT
	 	 	[**]	 	 	 	 	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	a. Right to conduct scheduled routine
audits of facility and quality systems not
to exceed one (1) occurrence per year
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Right to conduct “for cause” audits of
facility and quality systems as needed in
response to specific noncompliance events
[**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Right to maintain “man-in-plant”
presence during process start up and
execution of validation lots
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	ADVERSE EVENTS / PRODUCT COMPLAINTS
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	a. Regulatory notification of AE’s
Complaints as required by regulations
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Lead in AE / Complaint investigations
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Assistance in conducting AE / Complaint
investigations, including manufacturing
investigation
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	d. Final written report for AE / Complaints
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	e. Approval of report
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	 	 	 	 
	Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc.	 	Emergent BioSolutions
	Quality Agreement
	 	 	 	 
	 
	 	 	 	 
	CONFIDENTIAL

	 	Version 01
	 	Page 23 of 27

 

 

APPENDIX II

Summary of Responsibilities

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	RESPONSIBILITY
	 	 	Stage(s) of Manufacturing
	 	 	[**]	 	[**]
	Topic	 	Emergent	 	Talecris	 	Emergent	 	Talecris
	PRODUCT RECALL
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	a. Final Decision – [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Notification of other Company regarding
recall decision
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Notification of potential event that
may initiate recall
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	d. Impact of recall on Talecris filings
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	e. Impact of recall on Emergent filings
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	f. FDA notification of recall
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	g. Management of recall event
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	“LOOK BACK” PROCESS
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	a. Plasma collection center notification
for look backs involving units at Talecris
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Tracing of plasma units effected by
look back
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Destruction of plasma units not yet
processed and documentation of destruction
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	d. Supplying documentation of plasma unit
destruction to Emergent
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	e. Product impact assessment involving
plasma units that have been processed
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	f. Supply copies of documentation to
include plasma pool date and product lot
number(s) for processed/pooled plasma
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	REGULATORY
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	a. Single IND Submission by Emergent for
AIG Product
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. BLA Submission
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Notification of any regulatory action
which could affect finished product
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	d. Providing regulatory advice as needed
related to process related to Emergent
filings
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	e. Communications to Regulatory
Authorities concerning Finished Product
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	REGULATORY INSPECTIONS
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	a. Notification of regulatory inspection
by FDA, EU
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	 	 	 	 
	Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc.	 	Emergent BioSolutions
	Quality Agreement
	 	 	 	 
	 
	 	 	 	 
	CONFIDENTIAL

	 	Version 01
	 	Page 24 of 27

 

 

APPENDIX II

Summary of Responsibilities

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	RESPONSIBILITY
	 	 	Stage(s) of Manufacturing
	 	 	[**]	 	[**]
	Topic	 	Emergent	 	Talecris	 	Emergent	 	Talecris
	    Regulatory agency or other
governmental agency in conjunction with
the facilities, processes or quality
systems used to manufacture or support
Emergent finished product.
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Ability to maintain site presence
during inspection [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Approval of corrective actions
associated with identified deficiencies or
observations resulting from inspections
[**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	d. Review and approval of corrective
actions associated with identified
deficiencies or observations resulting
from inspections [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	e. Submission of
corrective actions to inspecting Authority
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	BIOLOGICAL PRODUCT DEVIATIONS
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	a. Final Decision – submission of BPDR
related to distributed product
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Submission of BPDR
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Lead – investigation for BPDR
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	d. Assistance – investigation including
manufacturing investigation
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	 	 	 	 
	Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc.	 	Emergent BioSolutions
	Quality Agreement
	 	 	 	 
	 
	 	 	 	 
	CONFIDENTIAL

	 	Version 01
	 	Page 25 of 27

 

 

APPENDIX II

Summary of Responsibilities

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	RESPONSIBILITY
	 	 	Stage(s) of Manufacturing
	 	 	[**]	 	[**]
	Topic	 	Emergent	 	Talecris	 	Emergent	 	Talecris
	CHANGE MANAGEMENT
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Talecris Initiated
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	a. Approval of changes to facility
or Gamunex process, including
testing and specifications , that do
not impact [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Notification of non-routine
changes to facility or Gamunex
process, including testing and
specifications, that have the
potential to impact [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Review and approval of
non-routine changes to facility or
Gamunex process, including testing
and specifications, that have the
potential to impact [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	d. Review of changes to facility or
Gamunex process, including testing
and specifications, required to
maintain compliance to GMP during
audit(s)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	e. Approval of changes to facility
or Gamunex process, including
testing and specifications, required
to maintain GMP
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Emergent Initiated
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	f. Approval of changes to process
including specifications that do not
impact facilities or Gamunex process
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	g. Notification of changes to
process including specifications
that have the potential to impact
facilities or Gamunex process
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	h. Approval of changes to process
including specifications that have
the potential to impact facilities
or Gamunex process
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	 	 	 	 
	Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc.	 	Emergent BioSolutions
	Quality Agreement
	 	 	 	 
	 
	 	 	 	 
	CONFIDENTIAL

	 	Version 01
	 	Page 26 of 27

 

 

APPENDIX II

Summary of Responsibilities

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	RESPONSIBILITY
	 	 	Stage(s) of Manufacturing
	 	 	[**]	 	[**]
	Topic	 	Emergent	 	Talecris	 	Emergent	 	Talecris
	VALIDATION
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	a. Maintaining validated state of
facility and equipment used for
Gamunex [**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Writing Process Validation
Protocol
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Approval of Process Validation
Protocol
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	d. Writing Process Validation Report
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	e. Approving Process Validation
Report
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	ANNUAL PRODUCT REVIEW / ANNUAL REPORT
	 	 	 	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	a. Preparation of summary data for
Emergent Annual Product Review
Report
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	b. Annual Product Review final report
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	c. Submission of Annual Report to FDA
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	 	 	 	 
	Emergent Product Development Gaithersburg Inc. AND Talecris Biotherapeutics Inc.	 	Emergent BioSolutions
	Quality Agreement
	 	 	 	 
	 
	 	 	 	 
	CONFIDENTIAL

	 	Version 01
	 	Page 27 of 27

 

 

EXHIBIT G

June 12, 2006

Mr. James A. Moose

Sr. Vice President

Talecris Biotherapeutics, Inc.

P.O. Box 110526

4101 Research Commons

79 T.W. Alexander Drive

Research Triangle Park, NC 27709

     Re: Exclusivity Agreement

Dear Jim,

     Reference is hereby made to the Product Supply Agreement (“Supply Agreement”),
dated as of June 12, 2006, by and between Emergent Product Development Gaithersburg Inc.
(“Emergent”) and Talecris Biotherapeutics, Inc. (“Talecris”). This letter (“Letter
Agreement”) sets forth the understanding between Emergent, including Emergent
BioSolutions Inc., and any and all Affiliates, and Talecris and Precision Pharma Services,
and any and all Affiliates regarding each Party’s noncompete and/or exclusivity obligations
in connection with the Supply Agreement. Capitalized terms used herein but not otherwise
defined herein shall have the meanings given to them under the Supply Agreement.

     1. Talecris Restrictions.

     (a) During the Term of the Supply Agreement, Talecris shall have the right to
research, develop and obtain regulatory approval for any pharmaceutical product that
contains AIG as an active ingredient (“Competing Product”), other than the Finished Product
(as defined in the Supply Agreement), either by itself or in collaboration with or on behalf
of a Third Party. Notwithstanding the foregoing, at all times during the Term of the Supply
Agreement, Talecris shall not, and shall cause its Affiliates not to do either of the
following

(except pursuant to the Supply Agreement):

(i) detail, promote, market, offer to sell, sell or otherwise dispose of any
Competing Product in the Territory, either by itself or in collaboration with or
on behalf of a Third Party; or,

(ii) acquire directly or indirectly any rights or interest in or to any
Competing Product which is detailed, promoted, marketed, offered for sale,
sold or otherwise disposed of in the Territory.

     (b) In the event that Talecris elects to terminate the Supply Agreement pursuant
to Section 10.02(b) thereof (Elective Termination by Talecris):

(i) the restrictions set forth in paragraph 1(a) above shall terminate upon
the second (2nd) anniversary of the Talecris Elective Termination Notice;
and

 

 

(ii) the restrictions set forth in paragraphs 2(a) and 2(b) below shall
terminate on the date of delivery to Emergent of the Talecris Elective Termination
Notice.

     2. Emergent Restrictions.

     (a) Pursuant to Section 4.01(c) (Pre-Commercial Target Yield) of the Supply
Agreement, should the Parties mutually determine that the Target Yields have been met, or if
the Parties mutually determine that the IgG Yields have failed to meet the Target Yields but
Emergent’s designated Third Party fails to achieve an AIG specific IgG Yield of at least [**]
percent ([**]%) greater than Talecris’ AIG specific IgG Yield, Emergent shall not purchase
commercial supplies of Competing Product or Finished Product from a Third Party other than
Talecris, from the Effective Date until the later of the end of (i) the Term of the Supply
Agreement, or (ii) the Exclusivity Extension Period (as defined in paragraph 3 below). For
the avoidance of doubt, Emergent may research, develop and obtain regulatory approval for
any pharmaceutical product that contains AIG as an active ingredient, either by itself or in
collaboration with or on behalf of a Third Party.

     (b) Subject to Section 4.04 (Alternative Supplier) of the Supply Agreement,
Emergent shall not purchase commercial supplies of Competing Product or Finished Product,
from a Third Party other than Talecris, from the Effective Date until the later of the end of
(i)
the Term of the Supply Agreement, or (ii) the Exclusivity Extension Period. For the
avoidance of doubt, Emergent may research, develop and obtain regulatory approval for any
pharmaceutical product that contains AIG as an active ingredient, either by itself or in
collaboration with or on behalf of a Third Party.

     (c) In the event that Emergent elects to terminate the Supply Agreement pursuant
to Section 10.02(a) thereof (Elective Termination by Emergent), the restrictions set forth in
paragraph 1(a) above shall terminate on the date of delivery to Talecris of the Emergent
Elective Termination Notice and the restrictions set forth in paragraphs 2(a) and 2(b) above
shall terminate upon the second (2nd) anniversary of the Emergent Elective
Termination
Notice.

     (d) In the event that Emergent terminates the Supply Agreement pursuant to
Section 10.02(e) (Supply Failure), Section 10.02(g) (Material Breach by Talecris), Section
10.02(i) (Pre-Commercial Failure) or Section 10.02(k) thereof (Safety Concerns), the
restrictions set forth in paragraphs 2(a) and 2(b) above shall terminate upon the effective
date
of termination of the Supply Agreement as set forth therein.

     (e) In the event that Emergent terminates the Supply Agreement pursuant to
Section 10.02(j) thereof (Termination of AIG Program), the restrictions set forth in
paragraphs 2(a) and 2(b) above shall terminate upon the later of (i) the end of the Term of
the
Supply Agreement, (ii) the fifth (5th) anniversary of the Effective Date of the
Supply
Agreement, or (iii) the end of any Exclusivity Extension Period. If, following termination of
the Supply Agreement pursuant to Section 10.02(j) thereof but prior to the end of the period
set forth in the immediately preceding sentence, Emergent proposes to purchase commercial
supplies of Finished Product from Talecris, Emergent shall Notify Talecris of such proposal
and Talecris shall have thirty (30) days from the date of such Notice to reinstate the Supply
Agreement.

2

 

     3. Extension. No later than [**] months prior to the end of the
Initial Term, Emergent may Notify Talecris that Emergent accepts extension of the
exclusivity period, in which case the Exclusivity Extension Period shall be deemed to be in
effect. If no such Notice is given, the restrictions set forth in paragraph 1(a) shall
terminate
upon the conclusion of the Initial Term. The “Exclusivity Extension Period” shall mean the
period commencing upon the conclusion of the Initial Term and ending on the fifth
(5th)
anniversary thereof.

     4. No Amendment. Other than as expressly set forth in this Letter Agreement,
this Letter Agreement shall in no way limit or modify either of the Parties’ obligations under
the Supply Agreement, or any other agreement between the Parties.

     5. Governing Law. This Letter Agreement 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 laws principles.

     If Talecris is in agreement with the foregoing provisions, please acknowledge its
agreement on the enclosed copy of this letter and return the signed copy to us.

	 	 	 	 	 
	 	EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.

 	 
	 	By /s/ R. Don Elsey
 	 
	 	 
	 
	 	Name:  	R. Don Elsey 	 
	 	Title:  	Treasurer 	 
	 

Agreed and acknowledged:

TALECRIS BIOTHERAPEUTICS, INC.

	 	 	 	 	 	 	 
	By /s/ [Illegible]
	 	 	 	 
	 
	 	 	 	 
	Name:

	 	 	 	 	 	 
	Title:

	 	 

Pres-CEO
	 	 	 	 
	Date:

	 	06/16/06
	 	 	 	Agreed and accepted by:

	 	 	 	 	 
	 	EMERGENT BIOSOLUTIONS INC.

 	 
	 	By: 	/s/ Daniel J. Abdun-Nabi
 	 
	 	Name: Daniel J. Abdun-Nabi 	 
	 	Title:   SVP, Corporate Affairs, General Counsel
	 
	 	Date:   June 20, 2006	 
	 

3

 

EXHIBIT H

Summary of Stability Testing

Samples will be stored at [**] through [**] from date of manufacture (Table 1) and for accelerated
stability tests, samples will be stored at [**] for [**] (Table 2).

Table 1 Stability testing to support storage at [**]°C

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Test Interval [**]
	Test	 	Initial	 	[**]	 	[**]	 	[**]	 	[**]	 	[**]	 	[**]	 	[**]	 	[**]
	Appearance: color, clarity
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	pH (diluted)
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	Molecular Weight Distribution
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	Anticomplement Activity
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	Prekallikrein Activator (PKA)
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	[**]
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	[**]
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	[**]
	 	 	X	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	X	 

Table 2 Accelerated stability testing ([**]°C)

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Test Interval, [**]
	Test	 	Initial	 	[**]	 	[**]	 	[**]	 	[**]
	Appearance: color, clarity
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	pH (diluted)
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	Molecular Weight Distribution
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	Anticomplement Activity
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	Prekallikrein Activator (PKA)
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	[**]
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	[**]
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 

 

			
	Note:	 	Protocols, procedures, timing and other terms to be further defined and agreed upon by the
parties in advance of implementation.

 

EXHIBIT I

Talecris Gamunex Activities

[**]

 

 

EXHIBIT J

Category A, B and C Bioterrorism Agents

Category A (definition below)

	 	•	 	Anthrax (Bacillus anthracis)
	 
	 	•	 	Botulism (Clostridium botulinum toxin)
	 
	 	•	 	Plague (Yersinia pestis)
	 
	 	•	 	Smallpox (variola major)
	 
	 	•	 	Tularemia (Francisella tularensis)
	 
	 	•	 	Viral hemorrhagic fevers (filoviruses [e.g., Ebola, Marburg] and arenaviruses [e.g., Lassa, Machupo])

Category B (definition below)

	 	•	 	Brucellosis (Brucella species)
	 
	 	•	 	Epsilon toxin of Clostridium perfringens
	 
	 	•	 	Food safety threats (e.g., Salmonella species, Escherichia coli O157:H7, Shigella)
	 
	 	•	 	Glanders (Burkholderia mallei)
	 
	 	•	 	Melioidosis (Burkholderia pseudomallei)
	 
	 	•	 	Psittacosis (Chlamydia psittaci)
	 
	 	•	 	Q fever (Coxiella burnetii)
	 
	 	•	 	Ricin toxin from Ricinus communis (castor beans)
	 
	 	•	 	Staphylococcal enterotoxin B
	 
	 	•	 	Typhus fever (Rickettsia prowazekii)
	 
	 	•	 	Viral encephalitis (alphaviruses [e.g., Venezuelan equine encephalitis, eastern equine
encephalitis, western equine encephalitis])
	 
	 	•	 	Water safety threats (e.g., Vibrio cholerae, Cryptosporidium parvum)

Category C (definition below)

	 	•	 	Emerging infectious diseases such as Nipah virus and hantavirus

Category Definitions

Category A Diseases/Agents

The U.S. public health system and primary healthcare providers must be prepared to address various
biological agents, including pathogens that are rarely seen in the United States. High-priority
agents include organisms that pose a risk to national security because they

	 	•	 	can be easily disseminated or transmitted from person to person;
	 
	 	•	 	result in high mortality rates and have the potential for major public health impact;

 

 

	 	•	 	might cause public panic and social disruption; and
	 
	 	•	 	require special action for public health preparedness.

Category B Diseases/Agents

Second highest priority agents include those that

	 	•	 	are moderately easy to disseminate;
	 
	 	•	 	result in moderate morbidity rates and low mortality rates; and
	 
	 	•	 	require specific enhancements of CDC’s diagnostic capacity and enhanced disease surveillance.

Category C Diseases/Agents

Third highest priority agents include emerging pathogens that could be engineered for mass
dissemination in the future because of

	 	•	 	availability;
	 
	 	•	 	ease of production and dissemination; and
	 
	 	•	 	potential for high morbidity and mortality rates and major health impact.

Source: Center for Disease Control and Prevention (CDC)

 

 

EXHIBIT K

Studies to be Conducted for Emergent

	1.	 	The Container Closure Study is no longer applicable.
	 
	2.	 	Details of the Process Validation Study is attached.

 

	 	 	 	 	 
	

	 	Process Verification Protocol

Anthrax Immune Globulin Intravenous (AIGIV) For

Emergent Product Development Gaithersburg Inc
	 	
[**]

Page 2 of 27

PROCESS VERIFICATION

OF

ANTHRAX IMMUNE GLOBULIN INTRAVENOUS (AIGIV)

FOR EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC

Buildings [**]

PROTOCOL

[**]

7/21/2006

[**]

Document Attributes:

Building [**], Anthrax IGIV, CCF#2006395

 

 

	 	 	 	 	 
	

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Emergent Product Development Gaithersburg Inc
	 	
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PROTOCOL APPROVAL SIGNATURES

Signatures below indicate that contents related to the individual areas of responsibility have been
reviewed and found to be acceptable. Emergent approvals are included on page 3.

	 	 	 
	Author

	 	Date
	/s/ Erin Sorrell

	 	7-21-06
	Print Name and Title: Erin Sorrell, Validation Specialist
	 	 
	 
	 	 
	Reviewer:
	 	 
	 
	Regulatory Affairs

	 	Date
	/s/ Joan Robertson

	 	7/21/06
	Print Name and Title: Joan Robertson, Deputy Director, Regulatory Affairs
	 	 
	 
	 	 
	Talecris Approvers:
	 	 
	 
	Qualification and Validation Engineering

	 	Date
	/s/ Jeff Crane

	 	7/21/06
	Print Name and Title: Jeff Crane, Validation Manager
	 	 
	 
	 	 
	Technical Operations - Fractionation

	 	Date
	/s/ Joe Barbour

	 	07/24/06
	Print Name and Title: Joe Barbour, Manager Production II
	 	 
	 
	 	 
	Technical Operations - Gamunex

	 	Date
	/s/ Jonathan Kent

	 	07/24/06
	Print Name and Title: Jonathan Kent, Technical Support Manager
	 	 
	 
	 	 
	Technology

	 	Date
	/s/ Douglas B. Burns

	 	7/24/06
	Print Name and Title: Doug Burns, Sr. Process Development Engineer II
	 	 
	 
	 	 
	Quality Operations - Fractionation

	 	Date
	/s/ Amy W. Durham

	 	7-24-06
	Print Name and Title: Amy Durham, Manager Quality
	 	 
	 
	 	 
	Quality Operations - Gamunex

	 	Date
	/s/ Cherilyn Metzler for Clara Schreiner

	 	7-24-06
	Print Name and Title: Clara Schreiner, Manager Quality
	 	 

 

 

	 	 	 	 	 
	

	 	Process Verification Protocol

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Emergent Product Development Gaithersburg Inc
	 	
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Page 4 of 27

PROTOCOL APPROVAL SIGNATURES (Continued)

Signatures below indicate that contents related to the individual areas of responsibility have been
reviewed and found to be acceptable.

Emergent Product Development Gaithersburg Inc Approvers:

	 	 	 
	Representative

	 	Date
	/s/ Jim Molver

	 	24 July 2006
	Print Name and Title: Jim Molver, Project Leader
	 	 
	 
	 	 
	Representative

	 	Date
	/s/ [illegible]

	 	24 July 2006
	Print Name and Title: Mike Cowan, VP of Quality
	 	 

 

 

	 	 	 	 	 
	

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TABLE OF CONTENTS

	 	 	 	 	 	 	 
	1.
	 	PURPOSE	 	 	5	 
	 
	2.
	 	SCOPE AND RATIONALE	 	 	5	 
	 
	3.
	 	REFERENCES	 	 	6	 
	 
	4.
	 	ACRONYMS AND DEFINITIONS	 	 	8	 
	 
	5.
	 	RESPONSIBILITIES	 	 	9	 
	 
	6.
	 	EQUIPMENT FUNCTIONAL REQUIREMENTS	 	 	10	 
	 
	7.
	 	EQUIPMENT SYSTEM DESCRIPTION	 	 	10	 
	 
	8.
	 	REQUIRED DOCUMENTATION	 	 	10	 
	 
	9.
	 	TEST PROCEDURE	 	 	11	 
	 
	10.
	 	SAMPLING PLAN	 	 	12	 
	 
	11.
	 	TEST FUNCTION 1 - PLASMA TESTING	 	 	14	 
	 
	12.
	 	TEST FUNCTION 2 - PLASMA POOL TO [**]	 	 	16	 
	 
	13.
	 	TEST FUNCTION 3 - [**]	 	 	16	 
	 
	14.
	 	TEST FUNCTION 4 - PASTE SUSPENSION AND [**]	 	 	17	 
	 
	15.
	 	TEST FUNCTION 5-SODIUM CAPRYLATE TREATMENT AND [**]	 	 	18	 
	 
	16.
	 	TEST FUNCTION 6 - CHROMATOGRAPHY PROCESSING OF AIGIV	 	 	19	 
	 
	17.
	 	TEST FUNCTION 7 - [**]	 	 	19	 
	 
	18.
	 	TEST FUNCTION 8 - [**]	 	 	20	 
	 
	19.
	 	TEST FUNCTION 9 - FINAL CONTAINER	 	 	22	 
	 
	20.
	 	INCIDENT LOG	 	 	26	 
	 
	21.
	 	POST EXECUTION APPROVAL SIGNATURES	 	 	27	 

 

 

	 	 	 	 	 
	

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	1.	 	PURPOSE

	 	1.1.	 	The purpose of this Process Verification (PV) protocol is to document the ability to
manufacture Anthrax Immune Globulin (AIG) for Emergent Product Development Gaithersburg Inc
(hereafter referred to as Emergent) from Source Plasma obtained from immunized donors in
the Fractionation Facility, Building [**] and the IGIV Chromatography Facility, Building
[**], at the Talecris Biotherapeutics Division in Clayton, NC.

	2.	 	SCOPE AND RATIONALE

	 	2.1.	 	The scope of this study is to verify that the [**] are capable of [**]. Emergent will
[**] and will provide the plasma to Talecris. The source plasma must meet all FDA and
Talecris requirements. The protocol requires samples at various points throughout the
production process from plasma pool to final container. Additionally, all Batch Production
Record (BPR) requirements must be met. The rationale for this approach is based on the
following documents used to validate the existing fractionation and purification processes:

	 	2.1.1	 	[**].
	 
	 	2.1.2	 	[**].

	 	2.2.	 	Study Design

	 	2.2.1.	 	[**].
	 
	 	2.2.2.	 	[**].
	 
	 	2.2.3.	 	[**].
	 
	 	2.2.4.	 	[**].

	3.	 	REFERENCES

	 	3.1.	 	Validation Procedures and Documents
	 
	 	 	 	[**]            [**]
	 
	 	 	 	[**]            [**]
	 
	 	 	 	[**]            [**]
	 
	 	 	 	[**]            [**]
	 
	 	 	 	[**]            [**]
	 
	 	 	 	[**]            [**]

	 	3.2.	 	Standard Operating Procedures
	 
	 	 	 	[**]            [**]
	 
	 	 	 	[**]            [**]
	 
	 	 	 	[**]            [**]

 

 

	 	 	 	 	 
	

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[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

[**]            [**]

	 	3.3.	 	Manufacturing Procedures - Batch Production Records

[**]            [**]

[**]            [**]

[**]            [**]

 

 

	 	 	 	 	 
	

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Emergent Product Development Gaithersburg Inc
	 	
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Page 8 of 27

	 	 	 	 	 
	 

	 	[**]
	 	[**]
	 

	 	[**]
	 	[**]
	 

	 	[**]
	 	[**]
	 

	 	[**]
	 	[**]
	 

	 	[**]
	 	[**]
	 

	 	[**]
	 	[**]
	 

	 	[**]
	 	[**]
	 

	 	[**]
	 	[**]
	 

	 	[**]
	 	[**]
	 

	 	[**]
	 	[**]
	 

	 	[**]
	 	[**]
	 

	 	[**]
	 	[**]
	 

	 	[**]
	 	[**]

	 	4.	 	ACRONYMS AND DEFINITIONS

	 	 	 	 	 
	 

	 	Acronym
	 	Definition
	 

	 	AIG
	 	Anthrax Immune Globulin
	 

	 	AIGIV
	 	Anthrax Immune Globuiin Intravenous
	 

	 	BPR
	 	Batch Production Record
	 

	 	C
	 	Celsius
	 

	 	CV
	 	Column Volumes
	 

	 	CWFI
	 	Cold Water For Injection
	 

	 	CZE
	 	Capillary Zone Electrophoresis
	 

	 	EIA
	 	Enzyme Immunoassay
	 

	 	HPLC
	 	High Performance Liquid Chromatography
	 

	 	IGIV-C
	 	Immunoglobulin Intravenous Chromatography
	 

	 	[**]
	 	[**]
	 

	 	ITS
	 	Incident Tracking System
	 

	 	kg
	 	Kilograms
	 

	 	NLT
	 	Not Less Than
	 

	 	NMT
	 	Not More Than

 

 

	 	 	 	 	 
	

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Emergent Product Development Gaithersburg Inc
	 	
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	 	OOS
	 	Out Of Specification
	 

	 	PKA
	 	Prekallikrein Activator
	 

	 	PV
	 	Process Verification
	 

	 	QOPQM
	 	Quality Operations — Product Quality Management
	 

	 	QOSCL
	 	Quality Operations — Supply Chain Laboratory
	 

	 	QVE
	 	Qualification and Validation Engineering
	 

	 	[**]
	 	[**]
	 

	 	[**]
	 	[**]
	 

	 	SOP
	 	Standard Operating Procedure
	 

	 	[**]
	 	[**]
	 

	 	[**]
	 	[**]

	5.	 	RESPONSIBILITIES

	 	5.1.	 	Qualification and Validation Engineering.

	 	5.1.1.	 	Prepares protocol, final report and final report packet.
	 
	 	5.1.2.	 	Coordinates the execution of the protocol including non-routine sampling with
all involved groups.
	 
	 	5.1.3.	 	Reviews all data collected during the execution for completeness and compliance
with acceptance criteria.
	 
	 	5.1.4.	 	Verifies that any incidents encountered during execution are documented
and resolved in accordance with [**].
	 
	 	5.1.5.	 	Reviews and approves the verification protocol, interim reports, and final

	 	 	 	report for quality, accuracy, and completeness.
5.2. Regulatory Affairs

	 	5.2.1.	 	Reviews the process verification protocol, interim reports, and final report for
quality, accuracy, and completeness.

	 	5.3.	 	Technical Operations

	 	5.3.1.	 	Reviews and approves the process verification protocol, interim reports, and
final report for quality, accuracy, and completeness.
	 
	 	5.3.2.	 	Assists QVE in the execution of the protocol, including scheduling the lots and
collecting samples,

	 	5.4.	 	Supply Chain / Materials Management

	 	5.4.1.	 	Schedules PV runs.

	 	5.5.	 	Engineering

	 	5.5.1.	 	Maintains all associated instruments in a calibrated state during the execution
of this protocol.

 

 

	 	 	 	 	 
	

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Anthrax Immune Globulin Intravenous (AIGIV) For

Emergent Product Development Gaithersburg Inc
	 	
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Page 10 of 27

	 	5.5.2.	 	Assists QVE in obtaining documentation required for the completion of the
protocol execution.

	 	5.6.	 	Quality Operations — Product Quality Management

	 	5.6.1.	 	Approves the process verification protocol, any incidents, interim reports, and
the final report.

	 	5.7.	 	Quality Operations — Supply Chain Laboratory / Bioanalytics

	 	5.7.1.	 	Completes all laboratory testing requirements stated in the protocol.
	 
	 	5.7.2.	 	Provides a detailed report of the laboratory test results to be included in the
final process verification report packet.

	 	5.8.	 	Emergent Representatives

	 	5.8.1.	 	Approves the process verification protocol, interim reports, and final report.

	 	5.9.	 	Technology

	 	5.9.1.	 	Approves the process verification protocol and final report.

	6.	 	EQUIPMENT/PROCESS FUNCTIONAL REQUIREMENTS

	 	6.1.	 	Plasma will be pooled in volumes of approximately [**] liters and fractionated by the
Cohn- Oncley method of cold ethanol fractionation to [**] according to approved BPRs and
SOPs at Talecris Biotherapeutics in Clayton, NC. Fractions will be held in cGMP condition
at [**]°C or below until a combined paste equivalent to approximately [**] liters of plasma
is collected. At that time, purification, formulation, fill and finish of the final AIG
product will be completed by the licensed process used by Talecris to manufacture Gamunex®.

	7.	 	EQUIPMENT SYSTEM DESCRIPTION

	 	7.1.	 	The same equipment licensed for use in the fractionation ([**]), purification ([**]),
filling ([**]) and packaging ([**]) of Gamunex® will be used for AIG manufacture.

	8.	 	REQUIRED DOCUMENTATION

	 	8.1.	 	All production data will be documented in approved BPRs at the time of execution.
Talecris Quality Operations will review the BPRs to verify that all license parameters are
met.
	 
	 	8.2.	 	The original data in support of the verification lots will be maintained by the
respective departments where testing is conducted. Copies of the original data will be
included in the final report package. QOSCL data will be maintained in Quality Operations
Release in lot packets.
	 
	 	8.3.	 	Incidents will be documented on an Incident Tracking System Notification Form and
recorded on the Incident Log sheet. Incident Reports will be included in the final report
package.

 

 

	 	 	 	 	 
	

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	9.	 	TEST PROCEDURE

	 	9.1.	 	Processing will occur according to approved BPRs, Sample Tables and Standard Operating
Procedures (SOPs).
	 
	 	9.2.	 	All operators involved in this PV must be trained on the approved documentation prior
to the execution of this protocol.
	 
	 	9.3.	 	Execution

	 	9.3.1.	 	Routine samples will be collected concurrent with production according to the
processing BPRs and approved sampling tables.
	 
	 	9.3.2.	 	Non-routine samples will be collected as described in this protocol.
	 
	 	9.3.3.	 	All routine samples will be submitted to Quality Operations — Supply Chain
Laboratory or Bioanalytics for testing following sample collection. Non-routine
samples to be tested by Emergent will be collected and stored as specified in this
protocol prior to shipment.
	 
	 	9.3.4.	 	The Run Number recorded on Test Function data sheets may be recorded as number
and alphabet (1a and 1b) for pooled lots that will be combined.
	 
	 	9.3.5.	 	Any results obtained outside of the specified test conditions or acceptance
criteria will be documented on an Incident Tracking System Notification Form and
recorded on the Incident Log sheet.

 

 

	 	 	 	 	 
	

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	 	[**]

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	10.	 	SAMPLING PLAN

	 	10.1.	 	The following table outlines samples for this process verification. Samples for
“In-Process Testing Routinely Performed by Talecris” column will be pulled by the Sample
Tables specified in each test function. (Qualification samples referred to in the Sample
Tables are not required for this verification protocol.) Samples for “In-Process Testing
Routinely Performed by Emergent” will be considered non-routine samples in this protocol.
Non-routine samples will be collected according to the test functions in this protocol.

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Sampling for
	 	 	 	 	 	 	In-Process Testing	 	In-Process Testing	 	Reference
	 	 	 	 	 	 	Routinely	 	Routinely	 	Standard
	 	 	 	 	 	 	Performed by	 	Performed by	 	Preparation by
	Sampling Point / Sample Description	 	Assays	 	Talecris	 	Emergent	 	Emergent
	[**]
	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	[**]
	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	[**]	 

 

 

	 	 	 	 	 
	

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Emergent Product Development Gaithersburg Inc
	 	[**]

Page 13 of 27

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Sampling for
	 	 	 	 	 	 	In-Process Testing	 	In-Process Testing	 	Reference
	 	 	 	 	 	 	Routinely	 	Routinely	 	Standard
	 	 	 	 	 	 	Performed by	 	Performed by	 	Preparation by
	Sampling Point / Sample Description	 	Assays	 	Talecris	 	Emergent	 	Emergent
	[**]
	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	[**]
	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	[**]	 
	[**]
	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	[**]	 

 

 

	 	 	 	 	 
	

	 	Process Verification Protocol

Anthrax Immune Globulin Intravenous (AIGIV) For

Emergent Product Development Gaithersburg Inc
	 	[**]

Page 14 of 27

	 	 	 
	Run Number                     

	 	Final Container Lot Number                     

	11.	 	TEST FUNCTION 1 — PLASMA TESTING

	 	11.1.	 	Purpose

	 	11.1.1.	 	To provide test Instructions to verify that the plasma used for the AIG meets
predetermined acceptance criteria.

	 	11.2.	 	Rationale

	 	11.2.1.	 	The plasma must be acceptable to be used in this process verification.

	 	11.3.	 	Procedure

	 	11.3.1.1.	 	      [**].
	 
	 	11.3.1.2.	 	      [**].
	 
	 	11.3.1.3.	 	      [**].
	 
	 	11.3.1.4.	 	      [**].

	 	11.3.4.1	 	      [**].
	 
	 	11.3.4.2	 	      [**].
	 
	 	11.3.4.3	 	      [**].

	 	 	 	 	 
	 	 	Verified by	 
	Sample progress	 	and Date	 
	Samples collected
	 	 	 	 
	Samples stored at [**]C
	 	 	 	 
	Samples sent to Emergent
	 	 	 	 

	 	 	 
	Comments:
	 	 
	 

	 	 

      

	 	 	 	 	 	 	 
	Reviewed By: 

	 	 	 	Date:	 	 
	 

	 
	 	 	 	 

 

 

	 	 	 	 	 
	

	 	Process Verification Protocol

Anthrax Immune Globulin Intravenous (AIGIV) For

Emergent Product Development Gaithersburg Inc
	 	[**]

Page 15 of 27

	 	 	 
	Run Number                     

	 	Final Container Lot Number
                                        

TEST
FUNCTION 1 (CONT’D) - PLASMA TESTING

	 	11.4.	 	Acceptance Criteria

	 	11.4.1.	 	[**].
	 
	 	11.4.2.	 	[**].

	 	 	 	 	 	 	 	 	 
	 	 	 	 	Acceptance	 	 	 	Verified
	Critical Parameters	 	Acceptance Criteria	 	Criteria Source	 	Actual Result	 	By/Date
	[**]
	 	[**]	 	 	 	 	 	 
	[**]
	 	[**]	 	 	 	 	 	 
	[**]
	 	[**]	 	 	 	 	 	 
	[**]
	 	[**]	 	[**]	 	 	 	 
	[**]
	 	[**]	 	 	 	 	 	 
	[**]
	 	[**]	 	 	 	 	 	 
	[**]
	 	[**]	 	 	 	 	 	 
	[**]
	 	[**]	 	[**]	 	 	 	 
	[**]
	 	[**]	 	[**]	 	 	 	 

	 	 	 
	Comments:
	 	 
	 

	 	 

      

	 	 	 	 	 	 	 
	Reviewed By: 

	 	 	 	Date:	 	 
	 

	 
	 	 	 	 

 

 

	 	 	 	 	 
	

	 	Process Verification Protocol

Anthrax Immune Globulin Intravenous (AIGIV) For

Emergent Product Development Gaithersburg Inc
	 	[**]

Page 16 of 27

	 	 	 
	Run Number                     

	 	Final Container Lot Number                     

12.
TEST FUNCTION 2 - PLASMA POOL TO [**]

	 	12.1.	 	Purpose

	 	12.1.1.	 	To provide test instructions to verify non-clarified pools can be successfully
processed to [**].

	 	12.2.	 	Rationale

	 	12.2.1.	 	The [**] must meet specifications and quality attributes in accordance with
Talecris’ requirements to be used in this process verification.

	 	12.3.	 	Procedure

	 	12.3.1.	 	[**].

	 	12.4.	 	Acceptance Criteria

	 	12.4.1	 	[**].

13.
TEST FUNCTION 3 - [**] TO [**]

	 	13.1.	 	Purpose

	 	13.1.1.	 	To provide test instructions to verify [**] can be successfully processed to [**].

	 	13.2.	 	Rationale

	 	13.2.1.	 	[**] must meet specifications and quality attributes to be used in this process
verification.

	 	13.3.	 	Procedure

	 	13.3.1	 	[**].

	 	13.4.	 	Acceptance Criteria

	 	13.4.1	 	[**].

	 	 	 
	Comments:
	 	 
	 

	 	 

      

	 	 	 	 	 	 	 
	Reviewed By:

	 	 	 	Date:	 	 
	 

	 	 
	 	 	 	 

 

 

	 	 	 	 	 
	

	 	Process Verification Protocol

Anthrax Immune Globulin Intravenous (AIGIV) For

Emergent Product Development Gaithersburg Inc
	 	[**]

Page 17 of 27

	 	 	 
	Run Number                     

	 	Final Container Lot Number                     

14.
TEST FUNCTION 4 - PASTE SUSPENSION AND [**]

	 	14.1.	 	Purpose

	 	14.1.1.	 	To provide test instructions to verify [**] can be successfully processed to [**].

	 	14.2.	 	Rationale

	 	14.2.1.	 	[**] suspension and [**] must meet specifications and quality attributes to be
used in this process verification.

	 	14.3.	 	Procedure

	 	14.3.1	 	[**].

	 	14.4.	 	Acceptance Criteria

	 	14.4.1	 	[**].

	 	 	 
	Comments:
	 	 
	 

	 	 

      

	 	 	 	 	 	 	 
	Reviewed By:

	 	 	 	Date:	 	 
	 

	 	 
	 	 	 	 

 

 

	 	 	 	 	 
	

	 	Process Verification Protocol

Anthrax Immune Globulin Intravenous (AIGIV) For

Emergent Product Development Gaithersburg Inc
	 	[**]

Page 18 of 27

	 	 	 
	Run Number                     

	 	Final Container Lot Number                     

15.
TEST FUNCTION 5 - SODIUM CAPRYLATE TREATMENT AND [**]

	 	15.1.	 	Purpose

	 	15.1.1.	 	To provide test instructions to verify [**] can be successfully processed to [**].

	 	15.2.	 	Rationale

	 	15.2.1.	 	Caprylate treatment and [**] must meet specifications and quality attributes to
be used in this process verification.

	 	15.3.	 	Procedure

	 	15.3.1	 	[**].

	 	15.4.	 	Acceptance Criterion

	 	15.4.1.	 	[**].
	 
	 	15.4.2.	 	[**].

	 	 	 	 	 	 	 	 	 
	 	 	 	 	Acceptance	 	 	 	Verified
	Critical Parameters	 	Acceptance Criterion	 	Criterion Source	 	Actual Result	 	By/Date
	Caprylate Treatment 2	 	 	 	 	 	 
	Caprylate
	 	[**]	 	[**]	 	 	 	 

	 	 	 
	Comments:
	 	 
	 

	 	 

      

	 	 	 	 	 	 	 
	Reviewed By:

	 	 	 	Date:	 	 
	 

	 	 
	 	 	 	 

 

 

	 	 	 	 	 
	

	 	Process Verification Protocol

Anthrax Immune Globulin Intravenous (AIGIV) For

Emergent Product Development Gaithersburg Inc
	 	[**]

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	Run Number                     

	 	Final Container Lot Number                     

16.
TEST FUNCTION 6 - CHROMATOGRAPHY PROCESSING OF AIGIV

	 	16.1.	 	Purpose

	 	16.1.1.	 	To provide test instructions to verify [**] can be successfully processed
through the Chromatography Columns.

	 	16.2.	 	Rationale

	 	16.2.1.	 	Chromatography flow-through must meet specifications and quality attributes to
be used in this process verification.

	 	16.3.	 	Procedure

	 	16.3.1.	 	[**].

	 	16.4.	 	Acceptance Criteria

	 	16.4.1	 	[**].

17.
TEST FUNCTION 7 - [**]

	 	17.1.	 	Purpose

	 	17.1.1.	 	To provide test instructions to verify column flowthrough material can be
successfully processed by [**].

	 	17.2.	 	Rationale

	 	17.2.1.	 	The [**] and formulation process must meet specifications and quality attributes
to be used in this process verification.

	 	17.3.	 	Procedure

	 	17.3.1	 	[**].

	 	17.4.	 	Acceptance Criteria

	 	17.4.1	 	[**].

	 	 	 
	Comments:
	 	 
	 

	 	 

      

	 	 	 	 	 	 	 
	Reviewed By:

	 	 	 	Date:	 	 
	 

	 	 
	 	 	 	 

 

 

	 	 	 	 	 
	

	 	Process Verification Protocol

Anthrax Immune Globulin Intravenous (AIGIV) For

Emergent Product Development Gaithersburg Inc
	 	[**]

Page 20 of 27

	 	 	 
	Run Number                     

	 	Final Container Lot Number                     

18.
TEST FUNCTION 8 - [**]

	 	18.1.	 	Purpose

	 	18.1.1.	 	To provide test instructions to verify that the formulated bulk can be
successfully prepared and processed to [**].

	 	18.2.	 	Rationale

	 	18.2.1.	 	The [**] must meet specifications and quality attributes to be used in this
process verification.

	 	18.3.	 	Procedure

	 	18.3.1.	 	[**].
	 
	 	18.3.2.	 	Collect non-routine TNA concentration [**]sample for Emergent.

	 	18.3.2.1.	 	[**].
	 
	 	18.3.2.2.	 	[**].
	 
	 	18.3.2.3.	 	[**].

	 	 	 
	 	 	Verified by
	Sample progress	 	and Date
	Samples collected
	 	 
	Samples stored at [**]°C
	 	 
	Samples sent to Emergent
	 	 

	 	 	 
	Comments:
	 	 
	 

	 	 

      

	 	 	 	 	 	 	 
	Reviewed By:

	 	 	 	Date:	 	 
	 

	 	 
	 	 	 	 

 

 

	 	 	 	 	 
	

	 	Process Verification Protocol

Anthrax Immune Globulin Intravenous (AIGIV) For

Emergent Product Development Gaithersburg Inc
	 	[**]

Page 21 of 27

	 	 	 
	Run Number                     

	 	Final Container Lot Number                     

TEST
FUNCTION 8 (CONT’D) - [**]

	 	18.4.	 	Acceptance Criteria

	 	18.4.1.	 	[**].
	 
	 	18.4.2.	 	[**].

	 	 	 	 	 	 	 	 	 
	 	 	 	 	Acceptance	 	 	 	Verified
	Critical Parameters	 	Acceptance Criteria	 	Criteria Source	 	Actual Result	 	By/Date
	[**]
	 	 	 	 	 	 	 	 
	Total Protein

	 	[**]
	 	[**]	 	 	 	 
	pH, diluted

	 	[**]
	 	[**]	 	 	 	 
	Glycine

	 	[**]	 	 	 	 	 	 
	IgA

	 	[**]
	 	[**]	 	 	 	 
	IgM

	 	[**]	 	 	 	 	 	 
	Anti-PA IgG ELISA

	 	[**]
	 	[**]	 	 	 	 
	TNA Assay
	 	 	 	 	 	 	 	 
	(Potency)

	 	[**]
	 	[**]	 	 	 	 
	[**]
	 	 	 	 	 	 	 	 
	Sterility

	 	[**]
	 	[**]	 	 	 	 

	 	 	 
	Comments:
	 	 
	 

	 	 

      

	 	 	 	 	 	 	 
	Reviewed By:

	 	 	 	Date:	 	 
	 

	 	 
	 	 	 	 

 

 

	 	 	 	 	 
	

	 	Process Verification Protocol

Anthrax Immune Globulin Intravenous (AIGIV) For

Emergent Product Development Gaithersburg Inc
	 	[**]

Page 22 of 27

	 	 	 
	Run Number                     

	 	Final Container Lot Number                     

19.
TEST FUNCTION 9 - FINAL CONTAINER

	 	19.1.	 	Purpose

	 	19.1.1.	 	To provide test instructions to verify the [**] can be successfully processed to
final container.

	 	19.2.	 	Rationale

	 	19.2.1.	 	Final containers must meet specifications and quality attributes to be used in
this process verification.

	 	19.3.	 	Procedure

	 	19.3.1	 	Fill the [**].
	 
	 	19.3.2	 	[**].
	 
	 	19.3.3	 	[**].

	 	19.3.3.1	 	[**].
	 
	 	19.3.3.2	 	[**].
	 
	 	19.3.3.3	 	[**].

	 	 	 
	 	 	Verified by
	Sample progress	 	and Date
	Samples collected
	 	 
	Samples stored at [**]°C to [**]°C
	 	 
	Samples sent to Emergent
	 	 

	 	 	 
	Comments:
	 	 
	 

	 	 

      

	 	 	 	 	 	 	 
	Reviewed By:

	 	 	 	Date:	 	 
	 

	 	 
	 	 	 	 

 

 

	 	 	 	 	 
	

	 	Process Verification Protocol

Anthrax Immune Globulin Intravenous (AIGIV) For

Emergent Product Development Gaithersburg Inc
	 	[**]

Page 23 of 27

	 	 	 
	Run Number                     

	 	Final Container Lot Number                     

TEST
FUNCTION 9 (CONT’D) - FINAL CONTAINER

	 	 	 	 	 	 	 
	 

	 	 	19.4.	 	 	Acceptance Criteria
	 

	 	 	 	 	 	
19.4.1. [**].
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	19.4.2. [**].

	 	 	 	 	 	 	 	 	 	 	 	 	 
	Critical	 	 	 	Acceptance	 	 	 	 	 	Verified	 
	Parameters	 	Acceptance Criteria	 	Criteria Source	 	Actual Result	 	 	By/Date	 
	Final Container
	 	 	 	 	 	 	 	 	 	 	 	 
	Appearance
	 	[**]	 	[**]	 	 	 	 	 	 	 	 
	Volumetric fill
check
	 	[**]	 	[**]	 	 	 	 	 	 	 	 
	Protein
concentration
	 	[**]	 	[**]	 	 	 	 	 	 	 	 
	Protein composition
	 	[**]	 	[**]	 	 	 	 	 	 	 	 
	Glycine
	 	[**]	 	 	 	 	 	 	 	 	 	 
	Sodium Caprylate
	 	[**]	 	 	 	 	 	 	 	 	 	 
	Prekallikrein
Activator
	 	[**]	 	 	 	 	 	 	 	 	 	 
	Anticomplement Assay
	 	[**]	 	[**]	 	 	 	 	 	 	 	 
	IgA
	 	[**]	 	[**]	 	 	 	 	 	 	 	 

	 	 	 
	Comments:
	 	 
	 

	 	 

      

	 	 	 	 	 	 	 
	Reviewed By:

	 	 	 	Date:	 	 
	 

	 	 
	 	 	 	 

 

 

	 	 	 	 	 
	

	 	Process Verification Protocol

Anthrax Immune Globulin Intravenous (AIGIV) For

Emergent Product Development Gaithersburg Inc
	 	[**]

Page 24 of 27

	 	 	 
	Run Number                     

	 	Final Container Lot Number                     

TEST
FUNCTION 9 (CONT’D) - FINAL CONTAINER

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Acceptance	 	 	 	Verified	 	 	 	 	 
	Critical Parameters	 	Acceptance Criteria	 	Criteria Source	 	Actual Result	 	By/Date	 	 	 	 	 
	IgM
	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 
	Sterility, USP
	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 
	Pyrogen, USP
	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 
	Safety
	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 
	Isoagglutinin Titer
	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 
	Molecular                             [**]
	 	 	 	[**]	 	 	 	 	 	 	 	 	 	 
	Weight                                  [**]
	 	 	 	[**]	 	 	 	 	 	 	 	 	 	 
	[**]
	 	 	 	[**]	 	[**]	 	 	 	 	 	 	 	 
	pH of 1% protein solution
	 	[**]	 	 	 	 	 	 	 	 	 	 	 	 
	Turbidity
	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 
	Anti-D
	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 

	 	 	 
	Comments:
	 	 
	 

	 	 

      

	 	 	 	 	 	 	 
	Reviewed By:

	 	 	 	Date:	 	 
	 

	 	 
	 	 	 	 

 

 

	 	 	 	 	 
	

	 	Process Verification Protocol

Anthrax Immune Globulin Intravenous (AIGIV) For

Emergent Product Development Gaithersburg Inc
	 	[**]

Page 25 of 27

	 	 	 
	Run Number                     

	 	Final Container Lot Number                     

TEST
FUNCTION 9 (CONT’D) - FINAL CONTAINER

	 	 	 	 	 	 	 	 	 
	 	 	 	 	Acceptance Criteria	 	 	 	Verified
	      Critical Parameters	 	Acceptance Criteria	 	Source	 	Actual Result	 	By/Date
	Osmolatity

	 	[**]
	 	[**]	 	 	 	 
	Identity: [**]

	 	[**]
	 	[**]	 	 	 	 
	[**] (Potency)

	 	[**]
	 	[**]	 	 	 	 
	Anti-PA IgG ELISA

	 	[**]
	 	[**]	 	 	 	 

	 	 	 
	Comments:
	 	 
	 

	 	 

	 	 	 	 	 	 	 
	 
	 
	Reviewed By:

	 	 	 	Date:	 	 
	 

	 	 
	 	 	 	 

 

 

	 	 	 	 	 
	

	 	Process Verification Protocol

Anthrax Immune Globulin Intravenous (AIGIV) For

Emergent Product Development Gaithersburg Inc
	 	[**]

Page 26 of 27

	20.	 	INCIDENT LOG

	 	20.1.	 	An Incident Tracking System Notification Form shall be completed for any incident
encountered during the execution of the protocol as according to [**]. The table below
will document the Incident number and the protocol section to which it applies as well as
ensure that each Incident’s Batch Disposition record has been satisfactorily resolved
before final approval.

Incident Tracking System Log

	 	 	 	 	 	 	 
	 	 	 	 	ITS or Batch	 	 
	 	 	 	 	Disposition	 	 
	Incident Number	 	Protocol Reference Section	 	Approval Date	 	Verified By/Date
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 	 	 

	 	 	 
	Comments:
	 	 
	 

	 	 

      

	 	 	 	 	 	 	 
	Reviewed By:

	 	 	 	Date:	 	 
	 

	 	 
	 	 	 	 

 

 

	 	 	 	 	 
	

	 	Process Verification Protocol

Anthrax Immune Globulin Intravenous (AIGIV) For

Emergent Product Development Gaithersburg Inc
	 	[**]

Page 27 of 27

	 	 	 
	Run Number                     

	 	Final Container Lot Number                     

21. POST EXECUTION APPROVAL SIGNATURES

     The signatures below indicate that all items in this executed protocol have been reviewed and found
acceptable and that all incidents have been satisfactorily resolved.

	 	 	 
	Qualification and Validation Engineering

	 	Date
	 
	 	 
	Print Name and Title:
	 	 

	 	 	 
	Qualification Operations — Product Quality Management — Fractionation

	 	Date
	 
	 	 
	Print Name and Title:
	 	 

	 	 	 
	Qualification Operations — Product Quality Management — Gamunex

	 	Date
	 
	 	 
	Print Name and Title:
	 	 

	 	 	 
	Comments:
	 	 
	 

	 	 

      

	 	 	 	 	 	 	 
	Reviewed By:

	 	 	 	Date:

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00111-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00111-of-00352.parquet"}]]