Exhibit 10.30
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933.
PRODUCTION AGREEMENT
THIS PRODUCTION AGREEMENT ("Agreement") is entered into as of this 5th day
of December, 2002 ("Effective Date") by and between Nabi, a Delaware corporation
having its principal place of business at 0000 Xxxx xx Xxxxxxxx Xxxxxxxxx, X.X.,
Xxxx Xxxxx, Xxxxxxx 00000, XXX ("Nabi") and Inhibitex, Inc., a Delaware
corporation having its principal place of business at 0000 Xxxxxxxx Xxxxxxx,
Xxxxx 000, Xxxxxxxxxx, Xxxxxxx 00000 ("Inhibitex").
RECITALS
WHEREAS Inhibitex owns the rights to MSCRAMM(TM) protein technology and
its application for the prevention and treatment of staphylococcal infections
and requires a supply of the Product (as herein defined) which satisfies the
requirements of cGMP (as herein defined), FDA (as herein defined) regulatory
requirements and Product Specifications (as herein defined) for use in humans as
a parenteral drug; and
WHEREAS Nabi has the capability to manufacture certain intravenous immune
globulin products and intermediates of same by a proprietary process from human
plasma in compliance with cGMP and FDA regulatory requirements and Product
Specifications at its facility in Boca Raton, Florida and has agreed to
manufacture the Product for Inhibitex in accordance with the terms of this
Agreement;
NOW THEREFORE in consideration of the mutual covenants set forth herein,
the parties hereto agree as follows:
1. DEFINITIONS
In this Agreement:
1.1. "Act" means The Federal Food, Drug, and Cosmetic Act of the United
States of America as the same may be amended from time to time.
1.2. "Affiliate" means, with respect to either Party, any corporation or
other business entity controlled by, controlling, or under common
control with, such Party. For this purpose, "control" shall mean
direct or indirect beneficial ownership of at least fifty percent
(50%) of the voting stock or income interest in such corporation or
other business entity, or such other relationship as, in fact,
constitutes actual control.
1.3. "Agreement" means this agreement together with the Schedules
attached hereto and any amendments agreed to in writing by the
Parties from time to time.
1.4. "Bulk Certificate of Analysis" means the certificate of analysis,
substantially in the form attached hereto as Exhibit I, to be
delivered by Nabi prior to the delivery of each batch of Bulk
Product pursuant to Section 2.5(k).
1.5. "Bulk Product" means human Staphylococcus immune globulin isolated
by the Nabi Process from Inhibitex Staph Plasma in conformity with
the Bulk Product Specifications.
1.6. "Bulk Product Specifications" means the specifications set forth on
Schedule A with which the Bulk Product will comply.
1.7. "By-Products" means plasma fractions, such as, but not limited to,
Cryoprecipitate or Fraction V, produced as part of the Nabi Process.
1.8. "CFR 21" means Title 21 of the Code of Federal Regulations as the
same may be amended from time to time.
1.9. "cGMP" means current Good Manufacturing Practices as established by
the FDA as the same may be amended from time to time.
1.10. "Competitive Product" means any Staphylococcus immune globulin
(human) product or intermediate produced by Nabi and similar to or
competitive with the Product.
1.11. "Effective Date" means the date set forth above.
1.12. "Facility" means Nabi's manufacturing plant in Boca Raton, Florida.
1.13. "FDA" means the United States Food and Drug Administration.
1.14. "Finished Product" means filled Bulk Product, in conformity with the
Finished Product Specifications.
1.15. "Finished Product Certificate of Analysis" means the certificate of
analysis, substantially in the form attached hereto as Exhibit II,
to be delivered by Nabi prior to the delivery of each batch of
Product pursuant to Section 2.5(g).
1.16. "Finished Product Delivery Date" means, with respect to any
Production Run, the date by which the Parties have agreed that
Finished Product processed during such Production Run shall be
delivered to Inhibitex, in accordance with Section 3.2.
1.17. "Finished Product Specifications" means the specifications set forth
on Schedule B with which the Finished Product will comply.
1.18. "Inhibitex Intellectual Property" means all inventions,
improvements, discoveries or know-how solely conceived, developed or
made by or on behalf of Inhibitex or its employees or consultants
prior to the Effective Date relating to the Product, including,
without limitation, the Inhibitex Technology.
1.19. "Inhibitex Staph Plasma" means the human plasma (containing certain
Staphylococcus aureus or epidermidis antibodies ) collected in
FDA-licensed plasma collection facilities and provided by Inhibitex
to Nabi.
1.20. "Inhibitex Technology" means all patents and patent applications
related to the Product.
1.21. "Label Copy" means any text to be applied to any container, label or
box or inserted into any package in connection with the manufacture
or distribution of the Product.
1.22. "Minimal Commercial Yield" means a yield of at least [ *** ] of
Finished Product, available for sale or use, including Finished
Product contained in any necessary test samples (exclusive of any
rejected materials), for each liter of Inhibitex Staph Plasma
processed.
1.23. "Nabi Freezer Facility" means Nabi's facility for the storage of
frozen plasma.
2
1.24. "Nabi Locations" collectively means the Facility and the Nabi
Freezer Facility.
1.25. "Nabi Intellectual Property" means all inventions, improvements,
discoveries or know-how solely conceived, developed or made by or on
behalf of Nabi or its employees or consultants prior to the
Effective Date relating to the Nabi Process, including, without
limitation, the Nabi Technology.
1.26. "Nabi Process" means the production process used by Nabi to produce
the Product and all written procedures and controls required to
comply with Nabi SOPs, cGMP and FDA regulatory requirements,
together with all modifications and improvements thereto.
1.27. "Nabi SOPs" means Nabi's standard operating procedures.
1.28. "Nabi Technology" means all patents and patent applications related
to the Nabi Process.
1.29. "Party" means Nabi or Inhibitex.
1.30. "Plasma Delivery Date" means, with respect to any Production Run,
the date by which the Parties have agreed that Inhibitex Staph
Plasma to be processed during such Production Run shall be delivered
to Nabi, in accordance with Section 3.2.
1.31. "Prior Approval Supplement" means a change in the manufacture or
testing of the Product that may be applicable to either a specific
batch of Product or all Product that requires FDA approval prior to
implementation of such change or sale of the Product.
1.32. "Product" means human Staphylococcus immune globulin isolated by the
Nabi Process from Inhibitex Staph Plasma in conformity with the
Product Specifications and includes Bulk Product and Finished
Product.
1.33. "Product Specifications" means the Bulk Product Specifications and
the Finished Product Specifications.
1.34. "Production Run" means the processing into Product of any individual
batch or batches of Inhibitex Staph Plasma.
1.35. "Production Run Date" means, with respect to any Production Run, the
date on which the Parties have agreed that such Production Run is
scheduled to begin, in accordance with Section 3.2.
1.36. "Proprietary Information" means all know-how, technology, expertise
or information, whether or not presently owned or controlled by a
Party or acquired or developed by a Party during the term of this
Agreement, including any applications for licensing, patenting or
copyrighting any of the foregoing and, with respect to Nabi, all
Nabi Intellectual Property, and with respect to Inhibitex, all
Inhibitex Intellectual Property.
2. PRODUCTION OF THE PRODUCT
2.1. Nabi will utilize the Nabi Process to produce the Product from
approximately [ *** ] liters of Inhibitex Staph Plasma per batch or,
with the consent of Inhibitex, such larger batches as Nabi may
hereafter have the capacity to process. Nabi shall use commercially
3
reasonable efforts to minimize loss of Inhibitex Staph Plasma due to
the Nabi Process and otherwise to optimize the yield of Product.
2.2. During the term of the Agreement, Inhibitex estimates that it will
purchase all Product resulting from Nabi's processing of
approximately the following volumes of Inhibitex Staph Plasma per
year:
[ *** ]
Nabi shall use commercially reasonable efforts to process additional
volumes of Inhibitex Staph Plasma to meet all of Inhibitex's
reasonable requirements for the Product.
2.3. The volumes of Product estimated in Section 2.2 shall be binding on
both Parties through and including the year 2005. The cancellation
by either Party of each or any binding Production Run shall be
subject to the cancellation fees set forth on Schedule D. Starting
on January 10, 2004, and on each anniversary of that date, Inhibitex
will supply Nabi with a forecast of the volume of Inhibitex Staph
Plasma to be processed in the then current calendar year and the
following two (2) calendar years (i.e. the years 2004, 2005 & 2006).
The forecast for the last year of the three-year forecast period
will become binding on both Parties and subject to the cancellation
fees set forth on Schedule D if, and only if, accepted by Nabi. Nabi
shall notify Inhibitex of its acceptance or rejection of each
forecast no later than on March 10 of the year such forecast is
delivered. Nabi shall not reject any forecast except in good faith.
An example of this revolving forecast can be found in Exhibit III.
In the event that the forecast for the last year of the three-year
forecast period is materially below or above the volume estimates
included in Section 2.2, Inhibitex will supply Nabi with a revised
non-binding forecast of needs for the remaining term of the
Agreement, in order to permit Nabi to plan future production.
2.4. No later than one hundred twenty (120) days prior to any intended
Production Run Date, Inhibitex shall deliver to Nabi an order (an
"Order") setting forth with respect to the intended Production Run
(i) the volume of Inhibitex Staph Plasma to be processed by Nabi and
(ii) the Finished Product Delivery Date. Within ten (10) days of
delivery of an Order to Nabi, Nabi shall notify Inhibitex whether it
accepts the Order and provide the Plasma Delivery Date and
Production Run Date with respect to the intended Production Run.
With respect to each Production Run, if Inhibitex, through no fault
of Nabi, fails to deliver the ordered volume of Inhibitex Staph
Plasma within one hundred twenty (120) days after the Plasma
Delivery Date, unless the Parties agree otherwise, Inhibitex shall
be deemed to have cancelled such Production Run subject to the
cancellation fees set forth on Schedule D.
4
2.5. Nabi shall:
(a) perform or arrange for the performance of all testing
(including bulk-testing but excluding viral marker and potency
testing) of Inhibitex Staph Plasma required to comply with
Nabi SOPs, Product Specifications, cGMP and FDA regulatory
requirements; provided, however, that Inhibitex will reimburse
Nabi for any PCR/NAT testing in the amounts set forth on
Schedule E;
(b) produce, test (including all required in process, bulk and
stability testing) and ship Product of at least Minimal
Commercial Yield in compliance with Nabi SOPs, Product
Specifications, cGMP and FDA regulatory requirements;
(c) prepare and maintain the production, control, distribution and
other records required to comply with cGMP and FDA regulatory
requirements;
(d) perform quality control testing and review of raw materials,
in-process materials, and Product according to Nabi SOPs, and
Finished Product Specifications, prior to the release of
Finished Product to Inhibitex;
(e) provide, from vendors qualified by Nabi, in accordance with
Nabi SOPs, cGMP and FDA regulatory requirements, all inactive
ingredients and other manufacturing and test materials (such
items to be in accordance with cGMP and FDA regulatory
requirements) necessary in order to manufacture Product in
accordance with Nabi SOPs, Product Specifications, cGMP and
FDA regulatory requirements;
(f) prepare, review and maintain all records and documents
required for the production of the Product in accordance with
the batch record including batch manufacturing/finishing
records and supporting documents, Nabi SOPs, certificates of
release and in-process controls;
(g) prepare and provide to Inhibitex, within fifteen (15) days
after final testing, a copy of the Finished Product
Certificate of Analysis and batch and test records for each
batch of Finished Product manufactured;
(h) retain and provide appropriate personnel, facilities,
validated equipment and support documents to carry out the
production of Product as required by this Agreement;
(i) be responsible for all actions and activities at the Facility
required for compliance with the Nabi Process, including cGMP;
(j) arrange for the filling of the Bulk Product in accordance with
cGMP and FDA regulatory requirements by a filling contractor
acceptable to Inhibitex;
(k) prior to delivering any Bulk Product to a filling contractor,
provide to Inhibitex a Bulk Certificate of Analysis;
(l) dispatch all Product and other deliverables related to the
Product to Inhibitex or its authorized agent according to
Inhibitex's instructions;
5
(m) notify Inhibitex of and provide Inhibitex, promptly, but in
any event within two (2) business days of receipt by Nabi's
Project Manager or his or her designee, with copies of all
communications received from the FDA respecting or that may
respect the Product. Nabi shall also promptly provide
Inhibitex with copies of Nabi's responses to all such
communications;
(n) permit representatives authorized by Inhibitex to inspect the
Nabi Locations and documents of Nabi which relate to the Nabi
Process and the Product and permit unrestricted access to
authorized representatives of Inhibitex to all activities
related to the manufacture of Product, including access to
operations, equipment, materials and documents and all aspects
of the Nabi Locations and any related premises and operations,
to observe and audit compliance with the Nabi Process, cGMP
and FDA requirements, subject to reasonable notice during
normal working hours;
(o) conduct activities identified as its responsibility in the
"Matrix of Responsibilities" attached as Schedule C;
(p) inform Inhibitex within two business days of official
notification of all regulatory inspections related to the
Product. Authorized Inhibitex representatives will be allowed,
but not required, to attend such inspections. The Inhibitex
representatives may contribute in matters related to the
Product;
(q) store, and maintain a system to ensure appropriate segregation
of, Inhibitex Staph Plasma and the Product in accordance with
cGMP and FDA regulatory requirements. Each month, Nabi shall
deliver to Inhibitex a temperature chart with respect to the
Nabi Freezer Facility;
(r) notify Inhibitex thirty (30) days in advance of the
implementation of any process, material, equipment or
facilities modification that could reasonably be expected to
affect the Product;
(s) notify Inhibitex of, and seek the approval of Inhibitex for,
any process or production deviation or test (including quality
control testing) or process failure within two (2) business
days of discovery;
(t) provide Inhibitex's approved Label Copy to the filling
contractor;
(u) obtain, and maintain throughout the term of this Agreement
property, product liability, general commercial and
professional liability insurance covering Nabi's obligations
hereunder in each case in amounts and with carriers acceptable
to Inhibitex and naming Inhibitex as an additional insured ,
and require Nabi subcontractors to obtain similar such
insurance coverage;
(v) use good faith efforts to obtain a sublicense from the New
York Blood Center permitting Nabi to use applicable patents in
connection with the services to be performed under this
Agreement; provided, however, that Inhibitex shall pay any
fees necessary to obtain such sublicense; provided, further,
however, that if Nabi is unable to obtain such sublicense
despite its good faith efforts, Inhibitex shall obtain a
license from New York Blood Center, on terms and conditions
acceptable to Inhibitex;
6
(w) implement current FDA regulatory requirements and industry
standards for product manufacture and viral inactivation;
(x) make a good faith effort to comply with European standards;
and
(y) cooperate with Inhibitex to use batch history to improve the
Product Specifications throughout the term of this Agreement.
2.6. Inhibitex shall at Inhibitex's expense:
(a) provide to Nabi Inhibitex Staph Plasma having a sufficient
potency for production of Product.
(b) within three (3) days of receipt of each Bulk Certificate of
Analysis, notify Nabi as to whether Nabi is authorized to
release the Bulk Product covered by such certificate to the
filling contractor;
(c) conduct activities identified as its responsibility in the
"Matrix of Responsibilities" attached as Schedule C;
(d) provide with each shipment of Inhibitex Staph Plasma a
certificate attesting that material has been collected in QPP
Certified and FDA-licensed facilities located in the U.S.,
under cGMP and in accordance with CFR 21. A unit listing,
including the results of all testing required by CFR 21, shall
also accompany each shipment;
(e) obtain and maintain throughout the term of this Agreement
general commercial insurance covering Inhibitex's obligations
hereunder, in each case in amounts and with carriers
acceptable to Nabi and naming Nabi as an additional insured.
(f) after receipt of a Biologics License Application ("BLA") for
the Product, obtain FDA lot release for each batch after
acceptance of the Product by Inhibitex; and
(g) after receipt of a BLA for the Product, provide to Nabi Label
Copy that has been approved by the FDA.
2.7. Investigational New Drug Application; BLA.
(a) Nabi will provide all necessary information to the FDA and
otherwise cooperate as reasonably requested by Inhibitex in
support of Inhibitex's Investigational New Drug Application
("IND") and a BLA related to the Product. Inhibitex shall have
all right, title and interest in and to any IND or BLA related
to the Product.
(b) Nabi will file the required amendments to its BLA to allow
manufacturing of Product in the Facility.
2.8. Acceptance of Finished Product by Inhibitex. Inhibitex shall
dispatch written notice of acceptance or rejection of any Finished
Product batch to Nabi within four (4) weeks of receipt of the
Finished Product Certificate of Analysis regarding such batch and
appropriate batch records and batch and test records from Nabi.
Notice of rejection shall specify the reasons for the rejection in
reasonable detail. Notice of acceptance shall state
7
that the acceptance is absolute or subject to conditions specified
in the notice, which may include FDA lot release in situations where
a Prior Approval Supplement is required by the FDA. If no notice of
acceptance or rejection is received from Inhibitex within four (4)
weeks of receipt of such certificate, the Product will be deemed to
be acceptable for release by Inhibitex. Within ten (10) business
days of receipt of notice of acceptance of Product or the date on
which the period for giving such notice expires (as the case may
be), Inhibitex shall provide written instructions to Nabi for the
delivery of Product to Inhibitex or its authorized agent.
3. SHIPPING, TITLE, RISK OF LOSS, RECORD RETENTION
3.1. Shipping/Title/Risk of Loss for Inhibitex Staph Plasma.
Inhibitex will be responsible for the shipping of Inhibitex Staph
Plasma in accordance with cGMP and FDA regulatory requirements to
the Nabi Freezer Facility. The Inhibitex Staph Plasma will be kept
in the Nabi Freezer Facility in accordance with Nabi SOPs, cGMP and
FDA regulatory requirements until ready to be sent to the Facility
for processing into the Product.
Inhibitex shall at all times retain sole title to the Inhibitex
Staph Plasma and all proteins contained therein.
Risk of loss for the Inhibitex Staph Plasma shall remain the
responsibility of Inhibitex until the Inhibitex Staph Plasma is
delivered to the Nabi Freezer Facility.
3.2. Shipping/Title/Risk of Loss for Finished Product.
Shipment of Finished Product shall be F.O.B. origin (Nabi's Facility
or warehouse) to the destination designated by Inhibitex. The
shipping agent and/or carrier shall be selected by Inhibitex.
Shipping schedules shall be selected by Inhibitex and shall be
agreed to by both Inhibitex and Nabi. All freight, insurance,
handling and forwarding agent's fees, taxes, storage and all other
charges applicable to Finished Product, if any, shall be the
responsibility of Inhibitex.
Inhibitex shall at all times retain sole title to the Bulk Product,
Finished Product and any By-Products.
Risk of loss for the Product shall remain the responsibility of Nabi
until the Product is delivered to Inhibitex's shipping agent from
Nabi's warehouse or Facility.
3.3. Production Records.
Nabi agrees to maintain records in accordance with the applicable
FDA rules and regulations relative to the materials used in the
Product and processing thereof in accordance FDA regulatory
requirements. Upon Inhibitex's request with a ten (10) business day
notice and at Inhibitex's expense, Nabi shall permit Inhibitex
and/or an independent auditor selected by Inhibitex to have access
to such records from time to time during ordinary business hours to
verify compliance by Nabi with such rules and regulations. Nabi
shall notify Inhibitex of any intention to dispose of such records
and Inhibitex may thereafter remove such records at it own expense.
8
4. SUPERIORITY
No provision on Inhibitex's purchase order form or on Nabi's general
conditions of sale or invoice which may purport to impose different
conditions upon Inhibitex or Nabi shall modify or otherwise alter
the terms of this Agreement.
5. DISCLAIMER/LIMITED LIABILITY
NOTWITHSTANDING ANYTHING ELSE IN THIS AGREEMENT, IN NO EVENT WILL
EITHER PARTY HAVE ANY LIABILITY FOR ANY LOSS OF INCOME, PROFIT,
INTEREST OR SAVINGS BY THE OTHER PARTY OR FOR ANY INDIRECT,
INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR SPECIAL DAMAGES SUFFERED BY
THE OTHER OR BY ANY THIRD PARTY, ARISING FROM OR RELATED TO THIS
AGREEMENT, REGARDLESS OF THE FORM OF ACTION, AND WHETHER IN
CONTRACT, INDEMNITY, WARRANTY, STRICT LIABILITY OR TORT (INCLUDING,
WITHOUT LIMITATION, NEGLIGENCE), OR ANY OTHER LEGAL OR EQUITABLE
GROUNDS, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF
SUCH LOSSES OR DAMAGES.
The foregoing limitation shall not apply to the costs incurred by
Inhibitex to obtain and audit a new replacement manufacturer and to
conduct new clinical trials if Nabi, in order to pursue a
potentially more economically advantageous alternative, fails or
refuses to perform in good faith any of its material obligations
under this Agreement.
6. PRICE AND PAYMENT
6.1. Processing Fees. Subject to Section 6.2, Inhibitex shall pay to Nabi
the processing fees set forth on Schedule D in consideration of the
services provided by Nabi pursuant to this Agreement.
6.2. Non-Payment.
(a) Inhibitex shall not be required to make any payment for any
Product that (i) does not meet the Product Specifications or
comply with cGMP or FDA regulatory requirements, (ii) is not
manufactured as required by the Nabi Process, unless the prior
written consent of Inhibitex to such deviation from the Nabi
Process has been obtained or such deviation does not, in the
judgment of Inhibitex, adversely affect the Product, (iii) is
not delivered, through no fault of Inhibitex, within one
hundred twenty (120) days after the Finished Product Delivery
Date applicable to the Production Run in which such Product
was processed, unless the Parties agree otherwise, or (iv)
beginning January 1, 2004, does not meet the Minimal
Commercial Yield. Any dispute regarding whether Product meets
the Product Specifications, cGMP, FDA regulatory requirements
or Minimal Commercial Yield shall be resolved by an
independent third-party laboratory to be selected by mutual
agreement of the Parties. The determination of such laboratory
shall be final and binding upon the Parties.
If any batch of Product (i) fails to meet Product
Specifications, (ii) fails to comply with cGMP or FDA
regulatory requirements, (iii) is not manufactured as required
by the Nabi Process or (iv) beginning January 1, 2004, does
not meet the
9
Minimal Commercial Yield, in any case, due solely to Nabi's
negligence in processing such batch, Inhibitex shall not be
responsible for the costs associated with the processing of
such batch and Nabi shall reimburse Inhibitex for the actual
cost of replacing the Inhibitex Staph Plasma from which such
batch was processed. If a batch of Product fails to meet
Product Specifications due solely to Inhibitex's error or
negligence, Inhibitex will be responsible for the costs
associated with the processing of such batch. If a batch of
Product fails to meet Product Specifications for any other
reasons, the parties shall split the cost of processing such
batch and the actual cost of replacing the Inhibitex Staph
Plasma from which such batch was processed in proportion to
their relative fault as they mutually agree. If the Parties
are unable to agree on their relative fault with respect to
such failure within twenty (20) days after such failure is
finally determined, their respective fault shall be determined
in accordance with Section 20.11 below.
6.3. Payments. Inhibitex shall pay all amounts required to be paid to
Nabi pursuant to this Agreement no later than thirty days from the
date of invoice in accordance with the instructions set forth on
Schedule D. Interest at a rate equal to prime commercial lending
rate of the Bank of America from time to time plus 1% shall be paid
on any payments received after thirty (30) days from the date of the
applicable invoice.
6.4. Additional Costs.
(a) Inhibitex shall pay Nabi [ *** ] on the Effective Date to
compensate Nabi for the costs it incurs for specifications,
dedicated equipment, process development, support data and
regulatory affairs support.
(b) Inhibitex shall reimburse Nabi for one half of the reasonable
costs incurred by Nabi in the construction of a cold thaw room
in the Facility (up to a maximum of [ *** ]) upon completion
of such construction; provided, however, that such
construction shall be completed no later than such one year
after the Effective Date.
(c) Inhibitex shall reimburse Nabi for any material costs incurred
as a result of viral inactivation, process, or facility
modifications resulting from mandatory changes in industry
standards, FDA regulatory requirements and/or cGMP or, if
applicable to the Product, European regulatory requirements.
The amount that Inhibitex shall pay to Nabi under this 6.4(c)
will be based on whether the mandatory modifications are
applicable to products manufactured in the Nabi facility other
than the Product, to the Facility in general, or to the
Product only. If the modifications relate to products
manufactured in the Nabi facility other than the Product or to
the Facility in general, the costs will be divided among all
affected parties in proportion to the ratio of the volumes of
material processed by Nabi on behalf of each such party in the
year the modifications are implemented to Nabi's processing
capacity in such year. For purposes of calculating costs,
expenditures that relate to capital improvements which are
reasonably expected to be capitalized according to GAAP shall
be the depreciated and/or amortized over their estimated
lives. The annual depreciation and or amortization charges
shall be used to calculate the cost of these expenditures in
each year. If the mandatory modifications are for the Product
only, and Inhibitex agrees to such modifications, Inhibitex
will bear the total cost in the year the costs are incurred
10
by Nabi. If the mandatory modifications do not relate to the
Product at all, Inhibitex shall bear no cost for such
modifications.
(d) Inhibitex may, from time to time, request Nabi to make other
changes in the Nabi Process or to the Product Specifications,
etc., including additional testing, which are not the result
of changes in industry or regulatory standards. Inhibitex must
submit requests for such changes in writing to Nabi. Nabi
shall not unreasonably withhold its consent to any such
changes. Any such Inhibitex requested change(s) which result
in increased costs to Nabi shall be reflected in adjusted
pricing, to be mutually agreed upon in good faith.
6.5. Travel Costs. Inhibitex shall be responsible for all travel and
accommodation expenses and other costs incurred by or payable in
respect of employees of Nabi who provide services or expertise to
the production and/or approval of the Product, provided that Nabi
obtains Inhibitex's prior written approval before such costs are
incurred.
6.6. Storage of Inhibitex Staph Plasma. Nabi will store Inhibitex Staph
Plasma at the Nabi Freezer Facility until required for processing.
Nabi will be compensated for the storage of such Inhibitex Staph
Plasma and associated activities as follows:
(a) Handling and Storage [ *** ]
(b) Driver and Equipment [ *** ]
(c) Labor [ *** ]
(d) Grade A Pallets [ *** ]
(e) Shrink Wrap [ *** ]
Note: Hourly rates for Driver and Equipment/Labor will be billed for
pulling samples and picking pools as well as normal processing in
and out of the Facility.
7. PROJECT MANAGERS
7.1. Appointment. Inhibitex and Nabi designate the following employees to
act as Project Managers:
Appointed By Name Title
------------ ---- -----
Nabi Xxxxxx Xxxxx Sr. Dir., Contract Manufacturing Operations
Inhibitex Xxxxx Xxxxxx Project Manager
Inhibitex and Nabi shall be entitled to replace any Project Manager
by giving written notice to the other Party within thirty (30) days
prior to replacement.
7.2. Duties.
The Project Managers designated by Inhibitex and Nabi shall
communicate and coordinate all Product related activities; but shall
not be able to change, amend or waive any terms of this Agreement
without a written instrument signed by authorized officers of
11
Inhibitex and Nabi.
8. INTELLECTUAL PROPERTY
8.1. Representations of Nabi. Nabi represents to Inhibitex that:
(a) Nabi is the sole owner of all rights, title and interest in
the Nabi Intellectual Property and the Nabi Process or has
secured the right to use the Nabi Intellectual Property from
any third parties, if necessary;
(b) To the best of Nabi's knowledge, the Nabi Intellectual
Property and the Nabi Process do not infringe upon any patents
issued worldwide.
8.2. Representations of Inhibitex. Inhibitex represents to Nabi that:
(a) Inhibitex is the sole owner of all rights title and interest
in the Inhibitex Intellectual Property, or has secured the
right to use the Inhibitex Intellectual Property from any
third parties, if necessary;
(b) Inhibitex has not granted, and during the term of this
Agreement Inhibitex will not grant, any right, license or
privilege relating to the production of the Product to any
third party; and
(c) To the best of Inhibitex's knowledge, the Inhibitex
Intellectual Property does not infringe upon any patents
issued worldwide.
8.3. Inhibitex Intellectual Property. All Inhibitex Intellectual Property
shall remain the sole property of Inhibitex. Inhibitex hereby grants
to Nabi a non-exclusive and non-transferable royalty-free license to
use the Inhibitex Intellectual Property solely to produce the
Product pursuant to the terms of this Agreement. Nabi shall not be
entitled to use the Inhibitex Intellectual Property for any purpose
or in any manner other than as set forth in this Agreement. Nabi
hereby disclaims any right or interest in the Inhibitex Intellectual
Property, except for the rights to the license specifically granted
in this Agreement.
8.4. Nabi Intellectual Property. All Nabi Intellectual Property shall
remain the sole property of Nabi. Inhibitex shall not be entitled to
use the Nabi Intellectual Property for any purpose or in any manner
other than as set forth in this Agreement. Inhibitex hereby
disclaims any right or interest in the Nabi Intellectual Property.
8.5. Improvements to Intellectual Property. All improvements or
modifications to the Inhibitex Intellectual Property developed or
discovered during the term of this Agreement shall be the sole
property of Inhibitex. Nabi shall have no right, title or interest
in such improvements or modifications. All improvements or
modifications to the Nabi Intellectual Property and the Nabi Process
developed or discovered during the term of this Agreement shall be
the sole property of Nabi. Inhibitex shall have no right, title or
interest in such improvements or modifications. Each Party shall
promptly deliver to the other Party copies of all tangible
embodiments of such improvements or modifications to the other
Party's Intellectual Property.
12
8.6. Notice. Nabi shall promptly notify Inhibitex of any improvements or
modifications to the Inhibitex Intellectual Property discovered or
developed during the term of this Agreement by delivering paper or
electronic copies of documents and material embodying the
improvements or modifications to the Inhibitex Intellectual Property
and, if necessary, by demonstration. If Inhibitex deems it
necessary, Inhibitex shall prepare and file applications for patents
for its products with respect to the improvements or modifications,
in its own name. Inhibitex shall give Nabi proper notice of all
patent applications for such improvements or modifications. Nabi
shall provide such information and assistance reasonably requested
by Inhibitex in connection with the preparing and filing of any
patent applications and in connection with the prosecution thereof.
Inhibitex shall compensate Nabi for all expenses incurred by Nabi in
providing such information and assistance.
8.7. Publication. Inhibitex shall be entitled to publish any improvements
or modifications to the Inhibitex Intellectual Property discovered
or developed during the term of this Agreement. Inhibitex may invite
Nabi or its employees to co-author such publications.
9. ADDITIONAL REPRESENTATIONS, WARRANTIES AND COVENANTS
9.1. Representations of Nabi. Nabi represents and warrants to Inhibitex
that, as of the Effective Date:
(a) the execution, delivery and performance by Nabi of this
Agreement (a) have been duly authorized by all requisite
corporate action, (b) do not and will not contravene or
violate the terms of the certificate of incorporation or
by-laws of Nabi or any requirement of law applicable to Nabi
or its assets, business or properties; (c) do not and will not
(with or without the giving of notice or the lapse of time or
both), conflict with, contravene, result in any violation or
breach of or default under any agreement under which Nabi is
obligated; and
(b) no approval, consent, compliance, exemption, authorization or
other action by, or notice to, or filing with or in respect
of, any Regulatory Authority or any other person is necessary
or required in connection with the execution, delivery or
performance by Nabi of this Agreement except consents,
authorizations, filings and notices which have been obtained
or made and are in full force and effect as of the Effective
Date.
9.2. Covenants of Nabi. Nabi hereby covenants that, throughout the term
of this Agreement, it will maintain all licenses and approvals
necessary to produce the Product in accordance with cGMP and FDA
regulatory requirements.
9.3. Representations of Inhibitex. Inhibitex represents and warrants to
Nabi that, as of the Effective Date:
(a) the execution, delivery and performance by Inhibitex of this
Agreement (a) have been duly authorized by all requisite
corporate action, (b) do not and will not contravene or
violate the terms of the certificate of incorporation or
by-laws of Inhibitex or any requirement of law applicable to
Inhibitex or its assets, business or properties; (c) do not
and will not (with or without the giving of notice or the
lapse of time or both), conflict with, contravene, result in
any violation or breach of or default under any agreement
under which Inhibitex is obligated; and
13
(b) no approval, consent, compliance, exemption, authorization or
other action by, or notice to, or filing with or in respect
of, any Regulatory Authority or any other person is necessary
or required in connection with the execution, delivery or
performance by Inhibitex of this Agreement except consents,
authorizations, filings and notices which have been obtained
or made and are in full force and effect as of the Effective
Date.
10. BY PRODUCTS
All By-Products resulting from Production Runs shall be the property of
Inhibitex. The Parties agree to negotiate in good faith the terms of any
sale of By-Products. If the Parties agree to the terms of any sale of
By-Products, Nabi shall have the exclusive right to sell the By-Products
on behalf of Inhibitex in accordance with such agreement.
11. THIRD PARTY CONTRACTORS
Inhibitex, in conjunction with Nabi, shall have the right to audit and
inspect all third party contractors, including all vendors and testing and
filling contractors, that Nabi may enter into agreements with in the
performance of its obligations under this Agreement. All such third party
contractors shall be subject to the continuing approval of both Nabi and
Inhibitex, which approval shall not, in either case, be unreasonably
withheld. Inhibitex reserves the right to reasonably withhold approval if
a third party contractor fails to materially comply with any FDA
regulatory requirement or is found to be materially deficient by an audit.
Nabi will use its best efforts to ensure that all agreements with such
third party contractors include provisions to maintain the confidentiality
of Inhibitex's Proprietary Information and provide Inhibitex rights with
respect to such contractors substantially similar to the rights with
respect to Nabi granted to Inhibitex under Section 2.5(n).
12. NO UNAUTHORIZED USE
During the term of this Agreement, Nabi shall not use any materials
supplied by Inhibitex pursuant to this Agreement for any purpose other
than performing its obligations under this Agreement.
13. NO DEBARMENT
Nabi represents and warrants that neither it nor any of its employees
involved in connection with this Agreement, is on the debarment list
prepared by the FDA Office of Regulatory Affairs, Compliance References:
Debarment List under Section 306(a) or Section 306(b) of the Act. Nabi
hereby covenants and agrees that if at hire or otherwise it learns of a
conviction of any of its employees performing hereunder of a crime that
could reasonably lead to debarment of such employee under Section 306(a)
or Section 306(b) of the Act it will make due inquiry as to whether such
conviction would, in fact, lead to a debarment under Section 306(a) or
Section 306(b) and promptly notify Inhibitex thereof. Furthermore, Nabi
agrees to notify Inhibitex upon the notice to it of conviction or
debarment under Section 306(a) or Section 306(b) of the Act of any of its
employees performing hereunder.
14. TERM
This Agreement shall commence as of the Effective Date and shall terminate
ten (10) years from the Effective Date. The pricing for the second five
(5) years of the term of this
14
Agreement shall be subject to adjustment as agreed to in good faith by the
Parties at least one hundred eighty (180) days prior to the fifth (5th)
anniversary of the Effective Date; provided, however, that Nabi shall be
entitled to a one-time 10% processing fee increase in addition to the
Consumer Price Index in effect in the sixth year of the Agreement.
15. TERMINATION
15.1. Rights of Both Parties. Either Party shall be entitled to terminate
this Agreement by written notice having immediate effect if:
(a) the other Party fails to make an undisputed payment of money,
within ninety (90) days of due date;
(b) the other Party defaults in any material respect in the
performance of any of its obligations or any of its
representations or warranties under this Agreement or
otherwise commits any material breach of this Agreement
(excluding a failure to make a payment of money when due) and
such default is not cured within twenty (20) days after
written notice specifying in reasonable detail the nature of
such default;
(c) the other Party becomes bankrupt, insolvent, makes an
assignment for the benefit of creditors or proposes or makes
any arrangements for the liquidation of its debts or a
receiver is appointed with respect to all or any part of the
assets of the other Party, or the other Party ceases or
threatens to cease to carry on business or to wind-up its
business, and such Party fails to provide within sixty (60)
business days after notice by the other Party such specified
assurances of performance as are reasonably requested in
writing by the other Party; or
(d) the other Party fails to promptly secure or renew any license,
registration, permit, authorization or approval necessary for
the conduct of its business in the manner contemplated by this
Agreement in any significant country, or if any such license,
registration, permit, authorization or approval is revoked or
suspended and not reinstated within sixty (60) days or
diligent efforts are being made to effect such reinstatement.
15.2. Right of Inhibitex. Inhibitex shall be entitled to terminate this
Agreement by written notice having immediate effect if:
(a) Nabi produces Finished Product of less than Minimal Commercial
Yield for the first two (2) consecutive Production Runs; or
(b) Inhibitex does not receive FDA approval for the Product or it
becomes apparent, in the sole determination of Inhibitex, that
the Product will not be approved and Inhibitex decides to
cancel substantially all further activity toward Product
approval.
15.3. Failure to Obtain License. If, despite their good faith efforts, the
Parties fail to obtain the necessary sublicense or license from the
New York Blood Center as provided in Section 2.5(v) within sixty
(60) days of the Effective Date, then this Agreement shall be
terminated and neither Party shall have any further obligation to
the other under this Agreement except pursuant to Sections 16.1(a),
(b) and (c).
15
16. CONSEQUENCES OF TERMINATION
16.1. Immediate Consequences. Upon the termination of this Agreement
pursuant to Section 15.1 of 15.2:
(a) the non-exclusive and non-transferable royalty-free license
for the Inhibitex Intellectual Property granted by Inhibitex
to Nabi in Section 8.3 shall immediately terminate;
(b) Nabi shall cease the manufacture of the Product and dispose of
any in-process materials and raw materials and Product in its
possession in accordance with the written directions of
Inhibitex;
(c) each tangible embodiment of all Inhibitex Intellectual
Property and Nabi Intellectual Property shall be immediately
delivered to its respective owner;
(d) all accrued or unpaid monetary obligations as of the date of
termination of this Agreement shall be immediately paid; and
(e) the rights or remedies to which the terminating Party may be
entitled shall not be limited or affected by the termination
of this Agreement.
16.2. Survival of Terms. Notwithstanding the termination or expiration of
this Agreement, all obligations relating to indemnification,
confidentiality, intellectual property and storage and maintenance
of Product herein shall survive termination of this Agreement.
17. INDEMNIFICATION AND RECALLS
17.1. General Indemnification. Each Party agrees to indemnify and hold the
other Party harmless against any and all losses, liabilities,
damages, claims, judgments, demands, and expenses, reasonable
attorneys fees and all other costs resulting from a claim brought by
a third party (hereinafter collectively or individually referred to
as a "Loss") arising out of or in connection with:
(a) the breach by the other Party or any of its representations or
warranties contained in this Agreement; or
(b) the non-performance, partial or total, of any covenants of the
other Party contained in this Agreement.
17.2. Indemnification by Inhibitex. Without limiting the general indemnity
provisions of Section 17.1, Inhibitex shall indemnify Nabi for any
Loss resulting from:
(a) any claim brought by a third party arising out of or connected
with any negligence or willful misconduct of Inhibitex in
connection with the performance of its obligations under this
Agreement;
(b) any claim that the Product infringes any patent, copyright,
trade secret or other such intellectual property right of any
third party; or
16
(c) the costs of recall made against or sustained by Nabi or any
third party arising out of the use or sale of the Product, to
the extent that such recall is attributable to Inhibitex's
negligence or willful misconduct.
17.3. Indemnification by Nabi. Without limiting the general indemnity
provisions of Section 17.1, Nabi shall indemnify Inhibitex for any
Loss resulting from:
(a) any claim brought by a third party arising out of or connected
with any negligence or willful misconduct of Nabi in
connection with the performance of its obligations under this
Agreement;
(b) any claim that the Nabi Process infringes any patent,
copyright, trade secret or other such intellectual property
right of any third party; or
(c) the costs of recall made against or sustained by Inhibitex or
any third party arising out of the use or sale of the Product,
to the extent that such recall is attributable to Nabi's
negligence or willful misconduct.
17.4. Indemnification Procedure. As a condition to the indemnified Party's
right to indemnification under this Section, the indemnified Party
shall give prompt notice to the indemnifying Party of any suits,
claims or demands by third parties which may give rise to any Loss
for which indemnification may be required under this Section, but
the indemnified Party's failure to do so shall not affect the
indemnifying Party's obligation hereunder except to the extent of
its actual damages as a result of such failure. The indemnifying
Party shall be entitled to assume the defense and control of any
suit, claim or demand of any third party at its own cost and
expense. If the indemnifying Party shall assume the defense of such
action, it shall not settle such action without the prior written
consent of the indemnified Party, which consent shall not be
unreasonably withheld or delayed; provided, however, that an
indemnified Party shall not be required to consent to any settlement
that (i) does not include as an unconditional term thereof the
giving by the claimant or the plaintiff of an unconditional release
of the indemnified Party from all liability with respect to such
action or (ii) involves the imposition of equitable remedies or the
imposition of any material obligations on such indemnified Party
other than financial obligations for which such indemnified Party
will be indemnified hereunder. As long as the indemnifying Party is
contesting any such action in good faith and on a timely basis, the
indemnified Party shall not pay or settle any claims brought in such
action without the prior written consent of the indemnifying Party.
Notwithstanding the assumption by the indemnifying Party of the
defense of any action as provided in this Section 17.4, the
indemnified Party shall be permitted to participate in the defense
of such action and to employ counsel at its own expense; provided,
however, that if the defendants in any action shall include both an
indemnifying Party and any indemnified Party and such indemnified
Party shall have reasonably concluded that counsel selected by
indemnifying Party has a potential conflict of interest because of
the availability of different or additional defenses to such
indemnified Party, such indemnified Party shall have the right to
select separate counsel to participate in the defense of such action
on its behalf, at the expense of the indemnifying Party, it being
understood, however, that the indemnifying Party shall not be liable
for the reasonable fees and expenses of more than one separate firm
of attorneys at any time for all indemnified parties (in addition to
local counsel) in such action or group of related actions.
17
If the indemnifying Party shall fail to notify the indemnified Party
of its desire to assume the defense of any such action within the
prescribed period of time, or shall notify the indemnified Party
that it will not assume the defense of any such action, then the
indemnified Party may assume the defense of any such action, in
which event it may do so acting in good faith in such manner as it
may deem appropriate, and the indemnifying Party shall be bound by
any determination made in such action.
17.5. Recalls.
Inhibitex shall have the right to control the arrangement of any
recall of the Product, and the Parties will cooperate with each
other in implementing such recall. Specifically, the Parties shall
cooperate in the event of a Product recall with respect to the
reshipment, storage and disposal of recalled Product; the
preparation and maintenance of relevant reports and records; and
notification to any recipients or users. In the event that any
governmental agency or authority issues a recall or takes similar
action in connection with the Product, or in the event either Party
determines that an event, incident or circumstance has occurred
which may result in the need for a recall or market withdrawal, the
Party with such information shall, within twenty-four (24) hours,
advise the other Party of the circumstances by telephone or
facsimile. Except as otherwise provided in Section 17.2 and Section
17.3 above, each Party shall bear the costs it incurs in connection
with any recall.
18. CONFIDENTIALITY
18.1. Confidentiality. Inhibitex and Nabi shall not disclose any to any
third party any Proprietary Information of the other Party received
pursuant to this Agreement or otherwise, or use any such Proprietary
Information in any manner, or for any purpose, that is not expressly
permitted hereby, without the prior written consent of such other
Party. These obligations shall not apply to:
(a) information which is known to the receiving Party on a
non-confidential basis prior to the time of disclosure and
documented by written records;
(b) information disclosed to the receiving Party by a third party
which has a right to make such disclosure;
(c) information which is independently developed by the receiving
Party without use of the Proprietary Information of the other
Party and documented by written records;
(d) information which becomes patented, published or otherwise
part of the public domain other than as a result of a breach
by the receiving Party of its obligations hereunder; or
(e) information which is required to be disclosed by law or
regulation or in response to a valid order of a court or other
governmental body, but only to the extent of and for the
purpose of such law, regulation or order, and only if the
receiving Party first notifies the disclosing Party of the
required disclosure and permits the disclosing Party, at its
expense, to seek an appropriate legal remedy to maintain the
information in secret.
18
Upon request by the Party providing the Proprietary Information, at
the expiration or earlier termination of this Agreement, the other
Party shall return all Proprietary Information and all copies
thereof that are in its possession. Each Party, if it so desires,
may retain in the files of its legal counsel, for archival purposes
only, one copy of all materials returned so as to provide a record
of such disclosure and return.
18.2. Remedies. Because of the unique nature of the Proprietary
Information, each Party acknowledges and agrees that the other Party
would suffer irreparable injury if such Party fails to comply with
the obligations in this Section 18 and that monetary damages would
be inadequate to compensate such Party for such breach. Accordingly,
each Party agrees that the other Party will, in addition to any
other remedies available to it at law, in equity or, without
limitation, otherwise, be entitled to injunctive relief and/or
specific performance to enforce the terms, or prevent or remedy the
violation, of this Section 18. This provision shall not constitute a
waiver by either Party of any rights to damages or other remedies
which it may have pursuant to this Agreement or otherwise.
19. COMPETITIVE PRODUCT
Permitted Activities. It is acknowledged and understood by the
Parties that Nabi may have developed or may be in the process of
developing a Competitive Product. Subject to Sections 8 and 18 of
this Agreement, nothing in this Agreement shall prohibit or restrict
Nabi from using the Nabi Intellectual Property and the Nabi Process
to develop and manufacture a Competitive Product for its own use or
another third party during the term of this Agreement.
20. MISCELLANEOUS PROVISIONS
20.1. Notice. Any notice permitted or required by this Agreement shall be
in writing and shall be delivered, mailed postage prepaid or sent by
e-mail, facsimile or express courier service to the following
addresses:
Inhibitex:
Inhibitex, Inc.
0000 Xxxxxxxx Xxxxxxx, Xxxxx 000
Xxxxxxxxxx, XX 00000
Attention: Xxxxx Xxxxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
email: xxxxxxx@xxxxxxxxx.xxx
with a copy to:
Xxxxxxx Berlin Shereff Xxxxxxxx, LLP
000 Xxxxxxxxx Xxxxxx
Xxx Xxxx, XX 00000
Attn: Xxxxx X. Xxxxxxxxx
Telephone: 000-000-0000
Facsimile: 000-000-0000
email: xxxxxxxxxxx@xxxxxxx.xxx
19
Nabi:
Nabi
0000 Xxxx xx Xxxxxxxx Xxxxxxxxx, X.X.
Xxxx Xxxxx, Xxxxxxx 00000
Attention: Xxxxxx Xxxxx, Sr. Dir. Contract
Manufacturing Operations
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
email: xxxxxx@xxxx.xxx
with a copy to:
Nabi
0000 Xxxx xx Xxxxxxxx Xxxxxxxxx, X.X.
Xxxx Xxxxx, Xxxxxxx 00000
Attention: General Counsel
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
email: xxxxx@xxxx.xxx
All such notices shall:
(i) if delivered, be deemed to have been given on receipt;
(ii) if transmitted by e-mail or facsimile, be deemed to have been
given on the day they were sent; and
(iii) if express courier, be deemed to have been given on the first
day following the date of sending.
20.2. Entire Agreement. This Agreement, including all attached Schedules
and Exhibits which are hereby incorporated by reference into this
Agreement, is the entire agreement between the parties with respect
to its subject matter and supersedes all other agreements, oral or
written, relating to its subject matter. There are no other
representations, understandings or agreements between the Parties
relative to such subject matter.
20.3. Modifications. No modifications or amendments to this Agreement
shall be valid unless in writing and signed by an authorized officer
of Inhibitex and Nabi.
20.4. Waiver. No waiver by either Party or any default shall operate as a
waiver of any other default or of the same default on a future
occasion.
20.5. Public Announcements. No public announcement relating to the Product
or this Agreement shall be made by either Party without the prior
written consent of the other Party, and neither Party shall use the
name of the other Party to this Agreement, any trademark or trade
name, or the name of any employee of the other Party in any
advertising or news release without the prior consent of the other
Party. Notwithstanding the foregoing, either Party may at any time
make any announcement which is required by applicable law, agency
regulation or administrative order.
20
20.6. Assignment. Neither Party shall assign this Agreement or any of its
rights or obligations hereunder without the express written consent
of the other Party, except as hereinafter provided. With prior
written notice to the other Party, either Party, without the other
Party's consent, may assign this Agreement to (i) an Affiliate, or
(ii) a successor of substantially its entire assets relating to the
products to be sold or the services to be performed hereunder, who
shall expressly assume in writing the performance of all of the
terms and conditions of this Agreement then to be performed by such
successor as if it were named herein as a party; provided, however,
that prior to the consummation of any such assignment by Nabi, Nabi
shall use good faith efforts to produce and deliver to Inhibitex
Product sufficient to satisfy Inhibitex's reasonable requirements
for eighteen (18) months. Any such assignment by Nabi shall not have
an adverse regulatory effect on Inhibitex or the Product. Any
purported assignment of this Agreement other than as provided in
this Section 20.6 shall be void. This Agreement shall be binding on
and enure to the benefit of each Party's successors and permitted
assigns.
20.7. Relationship. Inhibitex and Nabi are independent contractors and
nothing herein shall be deemed to establish a relationship of
principal and agent between Inhibitex and Nabi, nor any of their
agents or employees for any purpose whatsoever. This Agreement shall
not be construed as constituting Inhibitex and Nabi as partners, or
creating any other form of legal association or arrangement which
would impose liability upon one Party for the act or failure to act
of the other Party.
20.8. Currency. All payments required to be made under this Agreement
shall be made in legal currency of the United States of America. All
dollar amounts set forth in this Agreement are in United States
dollars.
20.9. Force Majeure. Failure of either Party to perform its obligations
under this Agreement shall not subject such Party to any liability
to the other Party if such failure is caused by any event and/or
circumstances beyond the reasonable control of such non-performing
Party, including, but not limited to, acts of God, fire, explosion,
flood, drought, war, terrorism, riot, sabotage, embargo, strikes or
other labor trouble, failure in whole or in part of suppliers to
deliver on schedule materials, equipment or machinery, interruption
of or delay in transportation, or national health emergency or
material regulatory change (an "Event of Force Majeure"). The Party
suffering an Event of Force Majeure shall use reasonable efforts to
perform its obligations hereunder as soon as practicable. If such
Party is not able to perform its obligations hereunder within ninety
(90) days of the Event of Force Majeure, the other Party may
terminate this agreement without liability.
20.10. Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of New York, USA without
regard to the choice of law provisions thereof.
20.11. Dispute Resolution. All disputes arising between the Parties under
this Agreement shall be settled by arbitration conducted in
accordance with the procedures of the commercial international
Arbitration Rules of the American Arbitration Association. In
addition, each Party shall have the right to take discovery of the
other Party by any or all methods provided in the United States
Federal Rules of Civil Procedure. The arbitrator(s) may upon request
exclude any evidence not made available to the other Party pursuant
to a proper discovery request from being used in the arbitration
proceeding. Any arbitration proceeding will be held in New York
City, New York, USA.
21
20.12. Severance. If any provision of this Agreement should be or become
fully or partly invalid or unenforceable for any reason whatsoever
or violate any applicable law, this Agreement is to be considered
divisible as to such provision and such provision is to be deleted
from this Agreement and the remainder of this Agreement shall be
deemed valid and binding as if such provision were not included. A
suitable provision which, as far as legally possible, comes nearest
to what the Parties desired according to the sense and purpose of
this Agreement, had this point been considered when concluding this
Agreement, shall be substituted for any such provision deemed to be
deleted.
21. LIST OF EXHIBITS AND SCHEDULES
The Exhibits and Schedules listed in this provision and attached
herewith are fully a part of this Agreement and cannot be modified
unless mutually agreed between the Parties:
Schedule A Bulk Product Specifications
Schedule B Finished Product Specifications
Schedule C Matrix of Responsibilities
Schedule D Terms of Payment
Schedule E PCR/NAT Testing
Exhibit I Bulk Certificate of Analysis
Exhibit II Finished Product Certificate of Analysis
Exhibit III Binding Volume Estimate Flow Chart
22
IN WITNESS WHEREOF, the proper officers of the parties hereto have
executed this Agreement.
INHIBITEX, INC. NABI
By: /s/ Xxxxxxx X. Xxxxxxxx By: /s/ Xxxxxx X. XxXxxx
------------------------- ----------------------
Name: Xxxxxxx X. Xxxxxxxx Name: Xxxxxx X. XxXxxx
Title: President and CEO Title: Executive Vice President and COO
23
SCHEDULE A
BULK PRODUCT SPECIFICATIONS
[ *** ]
24
SCHEDULE B
FINISHED PRODUCT SPECIFICATIONS
[ *** ]
25
Schedule C
MATRIX OF RESPONSIBILITIES
Man - manufacturing I - informed
QA - quality assurance C - contributes
QC - quality control R - responsible
FA - final approval A - audits
TASK NABI INHIBITEX
MAN QC QA
Procure components R C C A
Procure chemicals R C C A
Select Equipment R I C I
Procure plasma I I I R
Test & release components I R A A*
Test & release Chemicals I R A I
Generate in process Q.C. specifications R C C I
Sub-Contractor Activities I I R A
Perform IQ (equipment) R I A I
Manufacture Products R C A A
Perform environmental monitoring I R A A
Record Issuance/Review X X X X/R
Lot Release I C R FA
Regulatory Inspections I I R I
Document Control I I R A
Change Control C C R I
Product Recall I I C R
Variance Approval I I R C
Complaint Investigation I I C R
Non-conforming material review C C R FA
Calibration Program R I A I
Preventative Maintenance Program R I A I
--------------
* results of nucleic acid testing will be sent to Inhibitex for notification of
suppliers of Inhibitex Staph Plasma.
26
SCHEDULE D
TERMS OF PAYMENT
1. Processing Fees
Nabi will invoice Inhibitex for processing of each liter of Inhibitex Staph
Plasma processed in the manufacture of the Product as per the following
schedule.
For [ *** ] batches, [ *** ] per batch. For [ *** ] batches, the processing fee
shall depend on the yield as follows:
batches that yield [ *** ];
batches that yield [ *** ];
batches that yield [ *** ]; and
batches that yield [ *** ].
Processing fees are inclusive of all costs except the cost of plasma, any
solvent/detergent royalty, PCR/NAT testing, non-routine quality control testing,
shipping to and from Nabi and shipping to and from the filling contractor.
Beginning in 2003, processing fees will be adjusted annually based on the
increase in the Consumer Price Index for the preceding year.
The yields above [ *** ] can be pro-rated but the yields below [ *** ] cannot.
All yields are commercial yields.
Nabi will invoice Inhibitex for the Finished Product upon shipment.
2. Cancellation Fees.
If either Party cancels any binding Production Run, then it shall pay to the
other Party the following cancellation fees per batch for the calendar year
affected by the cancellation:
Date of Notice of Cancellation Cancellation Fees
------------------------------ -----------------
Less than or equal to 3 [ *** ]
months before the
Production Run Date
More than 3 months and [ *** ]
less than or equal to 6
months before the
Production Run Date
More than 6 months and [ *** ]
less than or equal to 9
months before the
Production Run Date
More than 9 months and [ *** ]
less than or equal to 12
months before the
Production Run Date
More than 12 months [ *** ]
before the Production
Run Date
27
3. Payment Instructions.
Payment terms are net 30 days from invoice date, payable by wire transfer to the
following account:
If to Nabi, to:
Bank of America
000 Xxx Xxxxxx, 0xx Xxxxx
Xxxxxx, XX 00000-0000
Acct. No.: 375-016-8862
ABA No.: 0000-0000-0
Swift code: NABKUS 44 DAL
If to Inhibitex, to:
Bank of America
000 Xxxxxxxxx Xx., XX, Xxxxx 0000
Xxxxxxx, XX 00000
ABA: 000000000
Name of Account: INHIBITEX, INC.
Account #: 000 000 0000
28
SCHEDULE E
PCR/NAT TESTING
Nabi or its agent will test pooled plasma and individual donations for
infectious diseases according to the following price schedule and according to
Nabi SOPs:
Master pools standard prices
Two reactions per primer set Qualitative
HIV RNA PCR [ *** ]
HCV RNA PCR [ *** ]
HBV DNA PCR [ *** ]
HAV RNA PCR [ *** ]
Parvo DNA PCR [ *** ]
Primary pools/Individual donor/Standard prices
One reaction per primer set Qualitative
HIV RNA PCR [ *** ]
HCV RNA PCR [ *** ]
HBV DNA PCR [ *** ]
HAV RNA PCR [ *** ]
Parvo DNA PCR [ *** ]
Nabi or its agent will pool Inhibitex donations at a charge of $1.50 per
donation.
Nabi will review test results. Nabi will notify Inhibitex in writing within five
(5) business days of discovery of a reactive unit(s). Inhibitex will be
responsible for notification of reactive donors to the applicable Plasma
Collection Center and notification of Nabi to pull and destroy units found
reactive. Upon such notification, Nabi shall pull and destroy such units in
accordance with Nabi SOPs.
29
EXHIBIT I
BULK CERTIFICATE OF ANALYSIS
QUALITY ASSURANCE BATCH RELEASE
PRODUCT NAME:
---------------------------------------------------
----------------------------------------------------------------
LOT NUMBER:
-----------------------------------------------------
MANUFACTURER:
NAME:
-----------------------------------------------------
ADDRESS:
--------------------------------------------------
-----------------------------------------------------
-----------------------------------------------------
FDA LICENSE #:
--------------------------------------------------
QUANTITY RELEASED:
----------------------------------------------
SIZE OF PACKAGE:
------------------------------------------------
EXPIRATION DATE:
------------------------------------------------
[ ] FULL RELEASE [ ] LIMITED RELEASE
COMMENTS:
-------------------------------------------------------
-----------------------------------------------------
-----------------------------------------------------
QA Batch Review and Released By Date
30
EXHIBIT II
FINISHED PRODUCT CERTIFICATE OF ANALYSIS
QUALITY ASSURANCE BATCH RELEASE
PRODUCT NAME:
---------------------------------------------------
---------------------------------------------------
LOT NUMBER:
-----------------------------------------------------
MANUFACTURER:
NAME:
-----------------------------------------------------
ADDRESS:
--------------------------------------------------
--------------------------------------------------
--------------------------------------------------
FDA LICENSE #:
--------------------------------------------------
QUANTITY RELEASED:
----------------------------------------------
SIZE OF PACKAGE:
------------------------------------------------
EXPIRATION DATE:
------------------------------------------------
[ ] FULL RELEASE [ ] LIMITED RELEASE
COMMENTS:
-------------------------------------------------------
-------------------------------------------------------
-------------------------------------------------------
QA Batch Review and Released By Date
31
EXHIBIT III
BINDING VOLUME ESTIMATE FLOW CHART
[ *** ]
32
