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Exhibit
10.33
MANUFACTURING SERVICES
AGREEMENT
Among
NABI
BIOPHARMACEUTICALS,
BIOTEST PHARMACEUTICALS
CORPORATION
And
BIOTEST AG
TABLE OF
CONTENTS
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Page |
| 1.
DEFINITIONS |
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1 |
| 2. SCOPE
OF WORK; ORDERS FOR PRODUCTS |
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5 |
| 3.
PROGRAM PERFORMANCE |
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8 |
| 4.
PROGRAM MATERIALS |
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9 |
| 5. USE OF
SUBCONTRACTORS |
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9 |
| 6.
COMPLIANCE WITH GOVERNMENT REGULATIONS |
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10 |
| 7.
RESIDUAL ACTIVITIES |
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11 |
| 8.
COMPENSATION |
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11 |
| 9. CHANGE
ORDERS |
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12 |
| 10.
CONFIDENTIAL INFORMATION/LEGAL PROCEEDINGS |
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12 |
| 11.
TRANSFER TO SUCCESSOR MANUFACTURER |
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14 |
| 12.
INVENTIONS AND PATENTS; TECHNOLOGY TRANSFER |
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14 |
| 13.
INDEPENDENT CONTRACTOR |
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15 |
| 14.
INSURANCE |
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15 |
| 15.
SHIPPING; RISK OF LOSS; INSPECTION |
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16 |
| 16.
DEFAULT |
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17 |
| 17.
DISPUTE RESOLUTION |
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17 |
| 18.
INDEMNIFICATION; LIMITATION OF LIABILITY |
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18 |
| 19.
REPRESENTATIONS, WARRANTIES AND COVENANTS |
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22 |
| 20. FORCE
MAJEURE |
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23 |
| 21. USE
OF NAMES |
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24 |
| 22. TERM;
TERMINATION |
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24 |
| 23.
MISCELLANEOUS |
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25 |
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| Exhibit A |
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Products |
| Exhibit B |
|
Manufacturing Cost Classification |
| Appendix 1-1 |
|
Initial Scope |
| Appendix 2 |
|
Pre-Approved Subcontractors |
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MANUFACTURING SERVICES
AGREEMENT
This MANUFACTURING SERVICES
AGREEMENT, effective as of December 4, 2007 (the “
Effective Date ”), is entered into by and among NABI
BIOPHARMACEUTICALS, a Delaware corporation (“ Nabi
”), having its principal place of business at 12276 Wilkins
Avenue, Rockville, MD 20852, BIOTEST PHARMACEUTICALS CORPORATION, a
Delaware corporation (“ Biotest ”), having its
principal place of business at 5800 Park of Commerce Boulevard,
Boca Raton, Florida 33487, and solely for purposes of
Section 23(k), BIOTEST AG, a company organized under the laws
of Germany (“ Biotest AG ”, and with Nabi and
Biotest, each a “ Party ”, and collectively the
“ Parties ”).
WHEREAS, on
September 11, 2007, Nabi, Biotest and Biotest AG, entered into
that certain Asset Purchase Agreement (the “ Asset
Purchase Agreement ”), pursuant to which, simultaneously
herewith, Biotest is purchasing assets used in, necessary for or
related to Nabi’s biologics strategic business unit,
including Nabi’s vaccine manufacturing facility located in
Boca Raton, Florida (the “ Facility ”), as and
to the extent set forth in the Asset Purchase Agreement;
WHEREAS, Nabi now desires
Biotest to perform certain manufacturing services previously
performed by Nabi at the Facility and to perform additional
manufacturing services at the Facility in accordance with the terms
of this Agreement and any executed Scope (as hereinafter defined),
and Biotest desires to perform such services on behalf of
Nabi;
WHEREAS, Nabi also desires
that, upon the request of Nabi, Biotest transfer to Nabi, a Nabi
Affiliate or a to-be-identified Third Party manufacturer certain
materials and information related to the Products, Program and
Process to enable Nabi or such third-party manufacturer to perform
the manufacturing services performed hereunder by
Biotest;
NOW, THEREFORE, in
consideration of the above statements and other good and valuable
consideration, the sufficiency and receipt of which are hereby
acknowledged, the Parties hereto agree as follows:
1. DEFINITIONS.
Terms defined elsewhere in
this Agreement shall have the meanings set forth therein for all
purposes of this Agreement unless otherwise specified to the
contrary. The following terms shall have the meanings set forth
below in this Section 1 :
“ Action ”
means any claim, action, suit, arbitration, inquiry, audit,
proceeding or investigation by or before any Governmental
Authority, arbitrator or arbitral panel.
“ Affiliate(s)
” means, with respect to any Person, any other Person
directly or indirectly controlling or controlled by, or under
direct or indirect common control with, such Person. For purposes
of this definition, a Person shall be deemed, in any event, to
“control” another Person if it owns or controls,
directly or indirectly, more than twenty-five percent (25%) of
the voting equity securities of the other Person.
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“ Agreement
” means this document as signed by the Parties including the
Scope and any referenced attachments and any amendments to this
document.
“ Batch ”
means a Lot of Drug Substance.
“ Batch Record
” means a complete manufacturing record for a Batch generated
by Biotest in the same manner as generated by Nabi prior to the
Effective Date or approved by Nabi and made concurrently with the
performance of each step of the production process for the Drug
Substance, Drug Substance testing, and Lot release data, such that
successive steps in such processes may be traced.
“Binding
Portion” has the meaning set forth in Sections 2(b)(i),
2(b)(ii) and 2(c)(i).
“ Biotest
Confidential Information ” means any information,
business, technical or financial data related to a Program that is
provided by Biotest to Nabi.
“ Biotest
Indemnitees ” has the meaning set forth in
Section 18(b) .
“ Biotest IP
” has the meaning set forth in Section 12(a)
.
“ Biotest Program
Manufacturing Know-How ” has the meaning set forth in
Section 12(a) .
“ Biotest SOP
” means the written standard operating procedures (SOPs) and
methods of Biotest, as the same may be amended, in Biotest’s
sole discretion, from time to time with reasonable prior notice to
Nabi, but in any event, such SOPs will comply with all applicable
laws in the United States.
“ Business Day
” means any day other than a Saturday, Sunday or a legal
holiday under the laws of the State of New York.
“ Certificate of
Analysis ” means a document signed by an authorized
representative of Biotest, describing the Specifications for, and
testing methods applied to, any Drug Substance, samples or other
Materials, and the results thereof.
“ cGMP ”
means current good manufacturing practices, as specified in
regulations promulgated from time to time by the FDA for the
manufacture and testing of pharmaceutical products.
“ Claim ”
means any claim, complaint, charge, action, proceeding, dispute,
investigation, lawsuit, demand or assessment.
“ Debarred
Entity ” means an entity that has been debarred by the
FDA pursuant to 21 U.S.C. § 335(a) or (b).
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“ Debarred
Individual ” means an individual that has been debarred
by the FDA pursuant to 21 U.S.C. § 335(a) or (b).
“ Drug Product
” means the final dosage form pharmaceutical product
containing Drug Substance that Nabi or its Affiliates will use for
clinical trials or for commercial supply, as applicable.
“ Drug Substance
” is any bulk purified Product produced using the Materials
and the Process.
“ Facility
” has the meaning provided in the Recitals.
“ FDA ”
means the United States Food and Drug Administration, or any
successor agency thereto.
“ GAAP ”
means United States generally accepted accounting principles as in
effect as of the Effective Date.
“ Losses ”
means, with respect to any Claim, all losses, expenses, obligations
and other liabilities or other damages (whether absolute, accrued,
contingent, fixed or otherwise, or whether known or unknown, or due
or to become due or otherwise), diminution in value, monetary
damages, fines, fees, penalties, interest obligations,
deficiencies, losses and expenses (including amounts paid in
settlement, interest, court costs, costs of investigators, fees and
expenses of attorneys, accountants, financial advisors and other
experts, and other expenses of litigation).
“ Lot ”
means the Drug Substance produced in a single Production Run of the
size specified in the applicable Scope with respect to the
particular Drug Substance, which may be contained in one or more
containers thereof.
“ Materials
” means any item necessary to produce Drug Substance using
the Process other than the technical information and intellectual
property provided by Nabi pursuant to Sections 4(a) and
4(b) .
“ Modification
” has the meaning set forth in Section 9
.
“ Nabi Confidential
Information ” means any information, business, technical
or financial data related to a Program that is provided by Nabi to
Biotest.
“ Person ”
means an individual, partnership, corporation, limited liability
company, joint stock company, unincorporated organization or
association, trust or joint venture, or a governmental agency or
political subdivision thereof.
“ Process
” means (i) the production methods, purification
processes and other know-how as provided by Nabi for use by Biotest
in the manufacture of Drug Substance, and (ii) any
modifications, enhancements or improvements to such methods or
processes that may be made by Biotest, its employees, agents,
consultants or contractors, solely or jointly with Nabi, from
time-to-time that are
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generated by Biotest as a result of
performing the activities described in this Agreement (though
Biotest will promptly notify Nabi of, and obtain consent of Nabi
for, any material modifications, enhancements or
improvements).
“ Process
Consumables ” means raw materials, filters, membranes,
disposable analytical test kits, tubing, filling needles,
disposable bags, disposable glass/plasticware, cleaning supplies
and other changeover parts consumed during the manufacture of Drug
Substance.
“ Product
” means any of the biopharmaceutical products described on
Exhibit A .
“ Product-Dedicated
Equipment ” means equipment, if any, that is acquired by
Biotest after the Effective Date with Nabi’s approval and at
Nabi’s sole expense, in accordance with this Agreement, to be
used by Biotest solely for the manufacture of Drug Substance
pursuant to a Scope under this Agreement.
“ Product
Invention ” means any improvement or invention relating
to a Product that is discovered by Biotest, its employees, agents,
consultants or contractors, solely or jointly with Nabi, solely in
connection with the activities described in this
Agreement.
“ Production Run
” means a full production of a Product pursuant to a Program,
from fermentation through Drug Substance.
“ Program
” means the services to be performed by Biotest for Nabi as
described in a particular Scope.
“ Quality
Agreement ” has the meaning set forth in
Section 3(c) .
“
Representatives ” means, with respect to any Person,
the directors, officers, managers, employees, independent
contractors, agents or consultants of such Person.
“ Scope ”
means a detailed scope-of-work document entered into by the Parties
for the performance by Biotest of certain services on behalf of
Nabi relating to Drug Substance, which shall be governed by, made
part of, and be subject to this Agreement as an appendix
hereof.
“ Specification
” means the requirements for tests, analysis, test procedures
and acceptable test results to which Drug Substance, raw materials
and excipients shall conform as set forth in a Scope, as amended
from time-to-time by mutual consent of the Parties, which consent
shall not be unreasonably withheld.
“ Third Party
” means any Person other than Nabi, Biotest and their
respective Affiliates.
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2. SCOPE OF WORK; ORDERS FOR
PRODUCTS.
(a) Scopes . From time
to time, the Parties will prepare and enter into detailed Scopes
for a Program. The Scopes shall be prepared by Nabi with
Biotest’s cooperation and shall be subject to the final
approval of Biotest, which shall not be unreasonably withheld, and
shall be attached as an Appendix 1 to this Agreement. The
first Scope document (“ Scope #1 ”) shall be
delivered to Biotest within thirty (30) days following the
Effective Date and shall be attached hereto as Appendix 1-1
. Each additional Scope, if any, shall be sequentially numbered
(i.e., Scope #2, Scope #3, etc.) and shall be attached as an
additional appendix and numbered as follows: Appendix 1-2 ,
Appendix 1-3 , etc.; provided , however , that
no additional Scopes shall be executed within the first twelve
(12) calendar months following the Effective Date. Biotest
will perform the services for Nabi in accordance with each executed
Scope. Each Scope will specify the relevant Products, Program
design, estimated duration of a Program and Production Runs, and
all other matters pertinent to completion of such Program, and will
be deemed to be a part of this Agreement and incorporated herein by
reference. Any Scope may be amended from time-to-time with the
mutual agreement of the Parties as described in
Section 9 . To the extent that any provision of this
Agreement conflicts with a Scope, the terms and provisions of the
applicable Scope will apply with respect to the subject matter
contained within such Scope.
(b) Forecasts and Purchase
Orders . During the Term the parties will undertake the
following procedures with respect to submitting forecasts and
purchase orders for Production Runs under a Scope:
(i) Scope #1 Forecast and
Related Purchase Orders . Nabi will include as part of Scope #1
Nabi’s proposed forecast for the first twelve
(12) calendar months of Drug Substance to be manufactured
under Scope #1 (the “ Scope #1 Forecast ”),
which Scope #1 Forecast shall include all Production Runs scheduled
to take place in the first twelve (12) calendar months
following the Effective Date. Within ten (10) calendar days
after delivery of Scope #1, (A) Biotest shall provide to Nabi
a written price quote for Scope #1 setting forth Service Fees
calculated as provided in Section 8 (“ Fee
Quote ”) and (B) Nabi and Biotest will work together
to establish a mutually agreeable Scope #1 Forecast, based on the
quoted Service Fees, for the first twelve (12) calendar months
following delivery of Scope #1. Within ten (10) calendar days
of issuance of the agreed upon Scope #1 Forecast, Nabi will submit
to Biotest a binding purchase order for all Production Runs
scheduled to take place during the first three (3) calendar
months of the Scope #1 Forecast. Nabi and Biotest will meet once
per month to discuss the schedule and agree upon any necessary
changes. No later than the fifteenth (15 th ) day of each calendar month, an
additional forecast month will be agreed upon and added in order to
provide a rolling twelve (12) month forecast. Each Party
agrees to use reasonable efforts to agree upon each additional
forecast month and, upon a failure to agree, Nabi will determine
such additional month’s forecast. In the event of a failure
of the parties to meet and agree on an additional forecast month,
the then fourth (4 th ) month of the current forecast will not become a Binding
Portion (as defined below) until ten (10) calendar days after
Nabi receives written notice from Biotest that such month’s
forecast will become a Binding Portion at such time, in order to
provide Nabi with an opportunity to alter such forecast month,
subject to Section 2(c) below. Biotest shall
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notify Nabi in writing Nabi
will submit to Biotest additional binding purchase orders, on a
monthly basis no later than the fifteenth (15 th ) day of the calendar month, for
Production Runs scheduled to occur on the current forecast within
the next three (3) calendar months, provided the purchase
orders covering such Production Runs have not been canceled as
permitted by Section 22 of this Agreement. Each
subsequently submitted purchase order shall include Production Runs
scheduled to take place during the three (3) calendar months
following the month in which it is submitted. Such three
(3) calendar month period of any Forecast following the month
in which a purchase order is submitted is referred to hereinafter
as a “ Binding Portion ” of each
Forecast.
(ii) Forecasts and
Purchase Orders for Subsequent Scopes . Included in each
subsequent Scope will be Nabi’s written forecast for the
first twelve (12) calendar months of Drug Substance to be
manufactured under such Scope (a “ Scope Forecast
”). No subsequent Scope will be executed within the first
twelve (12) months following the Effective Date. Within ten
(10) calendar days of the date of agreement by the Parties on
such Scope, (A) Biotest shall provide to Nabi a Fee Quote for
such Scope and (B) Nabi and Biotest will work together to
establish a mutually agreeable Scope Forecast based on the quoted
Service Fees for the first twelve (12) calendar months
following delivery of such Scope. Within ten calendar
(10) days of issuance of the agreed upon Scope Forecast, Nabi
will submit to Biotest a binding purchase order for all Production
Runs scheduled to take place during the first three
(3) calendar months of such Scope Forecast. Nabi and Biotest
will meet once per month to discuss the schedule and agree upon any
necessary changes. No later than the fifteenth (15
th
) day of each calendar
month, an additional forecast month will be added in order to
provide a rolling twelve (12) month forecast. Each Party
agrees to use reasonable efforts to agree upon each additional
forecast month and, upon a failure to agree, Nabi will determine
such additional month’s forecast. In the event of a failure
of the parties to meet and agree on an additional forecast month,
the then fourth (4 th ) month of the current forecast will not become a Binding
Portion (as defined below) until ten (10) calendar days after
Nabi receives written notice from Biotest that such month’s
forecast will become a Binding Portion at such time, in order to
provide Nabi with an opportunity to alter such forecast month,
subject to Section 2(c) below. Nabi will submit to
Biotest additional binding purchase orders, on a monthly basis, no
later than the fifteenth (15 th ) day of the calendar month, for additional Production
Runs scheduled to occur on the current forecast within the next
three (3) calendar months, provided the purchase orders
covering such Production Runs have not been canceled as permitted
by Section 22 of this Agreement. Each subsequently
submitted purchase order shall include Production Runs scheduled to
take place during the three (3) calendar months following the
month in which it is submitted. Such three (3) calendar month
period of any Forecast following the month in which a purchase
order is submitted is referred to hereinafter as a “
Binding Portion ” of each Forecast.
(c) Binding Purchase
Orders .
(i) If, in any rolling twelve
(12) month forecast provided under Scope #1 or any subsequent
Scope, no Drug Substance is forecast to be manufactured in any of
the fourth (4 th ),
fifth (5 th ) and sixth (6 th ) months of such rolling twelve (12) month forecast,
then such forecast of Drug Substance for such fourth (4
th
), fifth (5
th
) and sixth (6
th
) months shall be firm
and binding on Biotest and Nabi,
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and constitute a Binding Portion of such
Forecast. Each rolling twelve (12) month forecast. Each
subsequent rolling twelve (12) month forecast delivered under
Scope #1 and any subsequent Scope shall continue to reflect,
without alteration, any Binding Portions of any forecast amounts of
Drug Substance.
(ii) During the term of this
Agreement, if the aggregate number of Production Runs for any three
(3) calendar month period in any rolling twelve
(12) month forecast increases the forecast number of
Production Runs for such three (3) calendar month period from
any prior rolling twelve (12) month forecast by more than two
(2) Production Runs over such three (3) calendar month
period; Biotest shall not be obligated to complete such excess
Production Runs beyond such two (2) additional Production
Runs, but may complete such excess Production Runs beyond such two
(2) additional Production Runs in Biotest’s sole
discretion.
(iii) Nabi may notify Biotest
at any time in writing of an increase or decrease in any forecast
other than any Binding Portion of any forecast and such increase or
decrease shall be binding on the parties subject to, in the case of
an increase, the limitation in Section 2(c)(ii) above,
and in the case of a decrease, that for any three (3) calendar
month period in any rolling twelve (12) month forecast, other
than a termination pursuant to Section 22 , Nabi may
only decrease the forecast number of Production Runs for any three
(3) calendar month period from any prior rolling twelve
(12) month forecast by no more than two (2) Production
Runs over such three (3) calendar month period.
(iv) The forecast number of
Production Runs for any Binding Portion in any rolling twelve
(12) month forecast shall not deviate whatsoever from the
forecast number of Production Runs set forth for such Binding
Portion in the immediately preceding rolling twelve (12) month
forecast. If Nabi fails to order at least the number of Production
Runs forecast in any Binding Portion, then Nabi shall be obligated
to compensate Biotest for such shortfall in accordance with the
Service Fees set forth in the applicable Scope.
(iv) The Service Fees for any
purchase order for Production Runs shall be determined in
accordance with, and shall be payable at the times set forth in,
Section 8 of this Agreement.
(d) Program Development. The
Parties shall consult in developing a Program design in a manner
consistent with United States regulatory guidelines, including
cGMP. Biotest does not represent or warrant that any Program and/or
any Program results will result in obtaining marketing approval for
the Drug Substance or Drug Product at the time of submission of a
Program’s results to such agencies.
(e) Nabi Technical
Information . Biotest’s performance of a Program will be
based on Biotest SOP and technical information provided by or for
Nabi. This information will be incorporated into Program documents
(Batch Records, Specifications, etc.) that will be approved by Nabi
prior to use by Biotest. The Parties agree that these Program
documents will form the sole basis upon which manufacturing runs
will be performed.
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(f) Ongoing Meetings .
In addition to routine Program meetings, senior representatives of
the Parties shall meet on an occasional basis or as necessary, the
first meeting being no later than one (1) month from the
effective date of a particular Scope, to review progress of a
Program relative to the Scope and to agree on any necessary changes
to the Scope. Any disagreement between the Parties concerning a
Scope (including, without limitation, the failure of the Parties to
agree upon any necessary changes to the Scope) shall be resolved in
accordance with the dispute-resolution procedures set forth in
Section 17 hereof.
(g) Allocation of
Manufacturing Capacity . Biotest will allocate fifty percent
(50%) of its vaccine manufacturing capacity in the Facility,
calculated on an average monthly basis, to the production of the
Products, provided that the specific elements (e.g., scheduling of
specific manufacturing functions and processes) of such allocation
will be set forth in the Scopes.
3. PROGRAM
PERFORMANCE.
(a) Subject to
Section 2(f), Biotest shall provide the Facility, Materials
and staff necessary to complete a Program as provided in a
particular Scope, as it may be modified as provided herein, in
accordance with the terms of this Agreement.
(b) Biotest will appoint a
Biotest representative (the “ Program Manager ”)
to be responsible for oversight of a Program pursuant to a Scope by
Biotest. The Program Manager will coordinate performance of a
Program with a representative designated by Nabi (the “
Nabi Representative ”), which representative shall
have responsibility over all matters relating to performance of a
Program on behalf of Nabi. Unless otherwise agreed in a Scope, or
mutually agreed to by the Parties, all communications between
Biotest and Nabi regarding the conduct of a Program pursuant to a
Scope shall be addressed to or routed through the Program Manager
and Nabi Representative. Biotest may, at its option, substitute the
Program Manager during the course of a Program, on the condition
that the substitute Program Manager is reasonably acceptable to
Nabi, which acceptance will not be unreasonably withheld, delayed
or conditioned. Nabi may, at its option, substitute the Nabi
Representative during the course of a Program.
(c) The parties have prepared
and executed a detailed document (“ Quality Agreement
”) specifying the quality and regulatory procedures and
responsibilities of the parties hereunder with respect to the
manufacture of Drug Substance.
(d) Biotest shall produce
Drug Substance in accordance with the applicable Scope and use
commercially reasonable efforts to cooperate with Nabi or its
contractor in connection with filling and finishing of the
Product.
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4. PROGRAM MATERIALS.
(a) Under any Scope, Nabi is
responsible for providing Biotest with reference standards as
necessary to perform the Program as specified in a particular
Scope, as well as all documentation and such other data (including
any necessary Process documentation) as may be necessary for
Biotest to perform a Program as specified in a particular Scope and
to apprise Biotest of the stability of the Process characteristics,
proper storage, and manufacturing and safety requirements
including, without limitation, the Certificate of Analysis and/or
Material Safety Data Sheet, if applicable, relating to a Drug
Substance and reference standards as specified in a relevant
Scope.
(b) Nabi hereby grants to
Biotest a non-exclusive, royalty-free license, with no right to
grant sublicenses other than to permitted subcontractors, of any
intellectual property of Nabi or its Affiliates necessary for the
manufacture of Drug Substance under this Agreement, including but
not limited to the Process, and the provision of any other products
or services required under this Agreement. Such license is limited
and is exclusively for the purpose of the manufacturing of Drug
Substance hereunder at the Facility and the provision of any other
products or services required under this Agreement, and shall
terminate automatically and without further action by the Parties
on the termination of this Agreement.
(c) Nabi shall supply to
Biotest, in a timely manner and at no charge to Biotest, sufficient
quantities of hapten for use in and completion of a Program and
each manufacturing run. Biotest shall procure, subject to
Section 8(c) and expect as otherwise set forth herein,
all Materials, including Process Consumables, necessary for use in
and completion of a Program and each manufacturing run all of which
will comply with the Specifications; provided however, that until a
Drug Substance has been through at least three (3) at scale
Production Runs , the resulting Batch is required to comply with
the Batch Records, Process, and Biotest SOPs only and shall not be
required to comply with the Specifications applicable thereto. Only
after a Drug Substance has completed three (3) at scale
Production Runs must the resulting Batch comply with the applicable
Specifications.
(d) Upon completion of each
Program and/or termination of this Agreement, (i) unless
otherwise agreed in writing by the Parties, the applicable
Product-Dedicated Equipment will be returned to Nabi or its
designee, at Nabi’s expense and (ii) any remaining
samples, Materials, Drug Product or Drug Substance, or other
substances, documentation or data provided to Biotest or produced
by Biotest under this Agreement and solely related to the
applicable Drug Product or Drug Substance will be delivered, at
Nabi’s request, to Nabi or its designee, or, if not so
requested by Nabi, either retained by Biotest in compliance with
applicable regulatory requirements or destroyed/disposed of by
Biotest, in Biotest’s discretion.
5. USE OF
SUBCONTRACTORS.
(a) Biotest reserves the
right to employ subcontractors from time-to-time to undertake
certain activities related to a Program. All such subcontractors
will be pre-approved by Nabi, such approval not to be unreasonably
withheld or delayed. All approved
- 9 -
subcontractors for a Program will
perform services under a separate written agreement. A list of the
pre-approved subcontractors as of the Effective Date is attached
hereto as Appendix 2 . Biotest will ensure that each written
agreement with a subcontractor for a Program contains
(i) obligations of confidentiality and non-use consistent with
Section 10 of the Agreement, (ii) obligations
regarding compliance with laws consistent with Sections
19(h) , 19(i) and any Scope-specific terms which are
mutually agreed to by the Parties in writing, and
(iii) assignments, licenses or similar transfers of
intellectual property rights to the extent any intellectual
property rights are vested in the subcontractor as a result of
performing services for Nabi, in each case for the benefit of Nabi
(or for the benefit of Biotest, subject to Section 12
). If Biotest’s written agreements with its subcontractors do
not contain these provisions or Biotest is not able to obtain
written agreements, then Biotest will notify Nabi prior to
commencing work with that subcontractor and Biotest will not
commence work with that subcontractor for a Program until Nabi
provides its consent. Nabi will be responsible for delays to the
performance of a Program resulting from Nabi unreasonably delaying,
conditioning or hindering this consent. No subcontracting
arrangement will relieve Biotest of its obligations under this
Agreement, and Biotest shall remain primarily liable for the
performance of all obligations delegated to any subcontractor,
provided, however, that if a subcontractor agrees in writing that
Nabi is and shall be a Third Party beneficiary of the applicable
service agreement(s) between Biotest and such subcontractor, with
full right of enforcement, then Biotest shall not be liable for any
breach of this Agreement caused by subcontractor.
(b) Biotest will not be held
responsible or liable for the performance of any Third Party
retained directly by Nabi or its Affiliates to perform services
related to a Program, including, without limitation, any
distributors, consultants and testing entities.
6. COMPLIANCE WITH GOVERNMENT
REGULATIONS.
(a) Biotest will perform each
Program in accordance with each applicable Scope. Biotest will
comply with applicable government regulatory requirements
concerning cGMP appropriate to a particular Program.
(b) Should such government
regulatory requirements concerning cGMP applicable to a Program be
changed or Nabi require Biotest to comply with regulatory
requirements other than those of the United States or states in the
European Union, Biotest will comply with the new requirements or
foreign requirements, as applicable, subject to the remaining terms
of this Section 6(b) . In the event that compliance
with such new or foreign regulatory requirements necessitates, in
the reasonable discretion of Biotest, a change in the Scope or a
Program or the cost of the products or services provided by
Biotest, Biotest will submit to Nabi a revised technical and cost
estimate proposal for Nabi’s acceptance. Unless the parties
agree to a revised Scope or Program or cost estimate, as the case
may be, Biotest will not be obligated to continue to perform the
Scope or a Program or provide such products or services as Nabi has
requested that it be revised.
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7. RESIDUAL
ACTIVITIES.
Biotest will complete
scheduled residual activities as requested by Nabi relating to two
(2) NicVAX Drug Substance Batches. Such activities shall be
performed by Biotest without charge and in a manner consistent with
Nabi’s SOPs and practices prevailing prior to the Effective
Date.
8. COMPENSATION.
(a) Biotest shall be paid
service fees (the “ Service Fees ”) to perform
the services set forth in each Scope, in an amount equal to
Biotest’s cost to manufacture the Drug Substance as described
in such Scope, calculated in accordance with GAAP in substantially
the same manner as calculated by Nabi prior the Effective Date, in
accordance with the manufacturing cost classification as outlined
in Exhibit B , which exhibit shall be prepared by the
Parties within thirty (30) days of the Effective Date, but
specifically excluding depreciation, amortization and other
non-cash items. The parties shall refer to the manufacturing cost
classification, set forth in Exhibit B , for an example of
the manner in which the manufacturing costs are to be calculated
hereunder.
(b) The Parties shall agree
on estimated Service Fees for each Production Run in each Scope,
provided that any estimate of Service Fees, to the extent made in
good faith, will not be binding for any purpose, and Biotest shall
be relieved of its obligations hereunder with respect to such
Production Run in the event of failure of the Parties to agree
thereon.
(c) In the event that the
Parties agree that the existing equipment is insufficient to
produce the Products without further investment and efforts in
process development, Biotest will acquire, at Nabi’s sole
cost and expense and after Nabi’s prior written approval, any
additional equipment necessary to produce the Products in
accordance with a Program. In the event that Nabi does not approve
of such acquisition of additional equipment, Biotest shall have no
obligation to produce Products with the existing equipment that the
Parties agree is insufficient. Any portion of the cost of any
Product-Dedicated Equipment purchased for such Program will be
included in the Service Fee.
(d) Payments shall be made to
an account designated by Biotest and are due thirty (30) days
from the date of receipt of invoice, except that the Service
Fees’ payments are due at the times indicated in the relevant
Scope. Late payments are subject to an interest charge of one
percent (1%) per month.
(e) No more than once every
twelve (12) months and no later than sixteen (16) months
after receipt by Nabi of the relevant invoice, Biotest shall permit
an independent auditor appointed by Nabi, and reasonably acceptable
to Biotest, to conduct an audit of Biotest’s applicable books
and records relating to costs to manufacture Drug Substance for the
sole purpose of determining whether the correct Service Fees have
been charged to or paid by Nabi hereunder. The audits must be
conducted upon reasonable advance notice during the regular
business hours and in a manner not to interfere unduly with
Biotest’s operations. If any audit of
Biotest’s
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invoices or other records reveals any
variance from any invoice to Nabi, Biotest shall immediately refund
any excess payment received from Nabi. In addition, if any audit
reveals that Nabi has been overcharged by more than three percent
(3%) for the period audited, Biotest shall bear the
reasonable-costs and expenses of the independent auditor incurred
in conducting the audit. Otherwise, Nabi shall bear all costs and
expenses of such audit.
9. CHANGE ORDERS.
(a) In the event that the
Parties’ expectations regarding Scope and Program design and
objectives, timing, capital expenditure requirements, if any, and
other matters relating to the completion of a Program as set forth
in a Scope change in any material respect due to events outside the
reasonable control of the Parties, including, without limitation,
the events described in Section 20 or changes to any
applicable laws, rules or regulations, such that such
Program’s objectives cannot be achieved based on such
expectations (each being, a “ Modification ”),
then the Scope may be amended as provided in subsection (b) of
this Section 9 .
(b) In the event a
Modification is identified by Nabi or by Biotest, the identifying
Party shall notify the other Party as soon as is reasonably
possible. The identifying Party shall provide the other Party with
a change order containing the Modifications and an estimate of the
required adjustments to the estimated Service Fees within ten
(10) business days of receiving or delivering such notice (the
“ Change Order ”). The consent of the other
Par
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