CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
EXHIBIT 10.19
DATA TRANSFER,
CLINICAL TRIAL AND MARKET SUPPLY
AGREEMENT
THIS DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT (the
"Agreement"), is made effective as of the 27th day of January, 2000 (the
"Effective Date") by and between InterMune Pharmaceuticals, Inc. ("InterMune"),
a California corporation, having an address at 0000 Xxxx Xxxxxxxx Xxxx, Xxxx
Xxxx, Xxxxxxxxxx 00000-0000, XXX, and Boehringer Ingelheim Austria GmbH ("BI
Austria"), an Austrian corporation, having its registered office at Xx.
Xxxxxxxxxx-Xxxxx 0 - 00, X-0000 Xxxxxx, Xxxxxxxx of Austria. InterMune and BI
Austria may be referred to herein each individually as a "Party" and jointly as
the "Parties."
WHEREAS, pursuant to the terms of a Confidential Non-Disclosure Agreement dated
June 5, 1998, between InterMune and Xxxxxx+Co Ges mbH (now BI Austria) the
Parties have discussed and evaluated the feasibility of providing manufacturing
services regarding a recombinant gamma-interferon product for InterMune and
Xxxxxx (now BI Austria) has submitted a price quotation for these services; and
WHEREAS, InterMune holds an exclusive sublicense from Connetics Corporation
under Connetics' license from Genentech Inc., a company organized under the
laws of Delaware, ("Genentech") to manufacture, use and sell recombinant
human gamma-interferon ("INTERFERON GAMMA 1b", as further described herein)
products in the USA and certain other territories. INTERFERON GAMMA 1b is
approved by the FDA for the indication Chronic Granulomatous Disease, and is
sold in the USA under the trade-xxxx ACTIMMUNE-Registered Trademark- (the
"GENENTECH PRODUCT", as further described herein), and InterMune intends to
seek approval for additional indications; and
WHEREAS, Boehringer Ingelheim International GmbH (BII), an affiliate of BI
Austria and BI Pharma KG, holds an exclusive license from Genentech to
manufacture, use and sell INTERFERON GAMMA 1b in the BI Territory (as further
described herein), and is the registration-holder for an INTERFERON GAMMA 1b
product in certain countries of the BI Territory for the indication Chronic
Granulomatous
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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Disease. The trade-xxxx for INTERFERON GAMMA 1b product in Europe is
IMUKIN-Registered Trademark- (the "BI PRODUCT", as further described herein);
and
WHEREAS, BI Austria and its affiliate BI Pharma KG (as defined hereinafter) own
facilities specialized for cGMP manufacture of biopharmaceuticals and employ
personnel who have experience in the production, quality control as well as in
the registration of biopharmaceuticals; and
WHEREAS, InterMune wishes BI Austria, and BI Austria agrees, to (a) compare the
technical and analytical documentation of GENENTECH PRODUCT and BI PRODUCT, (b)
carry out conformance / qualification runs for the cGMP manufacture of a
finished INTERFERON GAMMA 1b product; (c) conduct an analytical comparison of
the GENENTECH PRODUCT and the BI PRODUCT in order to show comparability between
the GENENTECH PRODUCT and the BI PRODUCT; and (d) prepare for an FDA inspection
in order for BI Austria to be registered with the FDA as a cGMP-compliant
manufacturer for an INTERFERON GAMMA 1b product to be sold under the ACTIMMUNE
trademark for the US market and other territories controlled by InterMune; and
WHEREAS, InterMune wishes BI Austria, and BI Austria agrees, to manufacture and
supply InterMune with finished INTERFERON GAMMA 1b product for its conduct of
clinical trials and supply of market needs for a period of six (6) years in
accordance with the terms and conditions of this Agreement; and
WHEREAS, InterMune wishes BI Austria, and BI Austria agrees, to increase its
manufacturing capability for bulk and finished INTERFERON GAMMA 1b product in
accordance with a mutually agreed-upon plan and timeline as further described
herein.
NOW, THEREFORE, the Parties hereto agree as follows:
1. DEFINITIONS
The following capitalized definitions will apply throughout this Agreement:
1.1. AFFILIATE means (i) any corporation or business entity fifty percent
(50%) or more of the voting stock of which is and continues to be
owned directly or indirectly by any party hereto; (ii) any corporation
or business entity which directly or indirectly owns fifty percent
(50%) or more of the voting stock of any party hereto; or (iii) any
corporation or business entity under the direct or indirect control of
such corporation or business entity as described in (i) or (ii).
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
2 of 66
1.2. APPROVAL means a regulatory approval required from a HEALTH AUTHORITY
in order to manufacture BBS or PRODUCT for use in clinical trials or
market supply as applicable, in the applicable jurisdiction.
1.3. ATS means the Austrian Shilling.
1.4. BI AUSTRIA'S IMPROVEMENTS shall mean all INFORMATION comprising any
inventions, modifications and/or improvements to the INTERMUNE
TECHNOLOGY or to the GENENTECH TECHNOLOGY, that BI Austria or BI
Pharma KG conceive of or reduce to practice pursuant to this
Agreement, either individually or in conjunction with one or more
third parties or BI Affiliates, including all patent and patent
applications covering any of the foregoing.
1.5. BI AUSTRIA'S TECHNOLOGY means all INFORMATION in the field of
manufacturing and testing of biopharmaceuticals, including without
limitation the MANUFACTURING PROCESS but only to the extent that it
relates solely to BI PRODUCT, and including all patents and patent
applications covering any of the foregoing, that are owned or
CONTROLLED by BI Austria or BI Pharma KG during the term of this
Agreement and that are related to or useful in BI Austria's carrying
out its obligations under this Agreement, but specifically excluding
INTERMUNE'S TECHNOLOGY and BI AUSTRIA'S IMPROVEMENTS.
1.6. BI TERRITORY means the territory described in EXHIBIT 1 hereto.
1.7. BII means Boehringer Ingelheim International GmbH, an AFFILIATE of BI
Austria GmbH and BI Pharma KG.
1.8. BI PHARMA KG means BI Austria's AFFILIATE BI Pharma KG, FRG-88397
Biberach an der Riss, Xxxxxxxxxxxx Xxxxxxx 00, Xxxxxxx, owning an
FDA inspected and cGMP-certified facility.
1.9. BI PRODUCT means the liquid formulation of INTERFERON GAMMA 1b
approved in various countries of the BI Territory for the treatment of
Chronic Granulomatous Disease, and manufactured by BI Austria and BI
Pharma KG for sale. In Europe the BI PRODUCT is sold under the
trademark IMUKIN-Registered Trademark-.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
3 of 66
1.10. BLA means a Biologics License Application, as defined by the
regulations promulgated under the FD&C ACT, and any equivalent
application with respective HEALTH AUTHORITIES.
1.11. BULK BIOLOGICAL SUBSTANCE (BBS) means a bulk form of the PRODUCT. This
bulk form is the [ * ].
1.12. BULK SPECIFICATIONS mean the specifications for BBS listed in EXHIBIT
2.
1.13. cGMP means the current Good Manufacturing Practices of all applicable
HEALTH AUTHORITIES, including without limitation the FDA, and
including without limitation all applicable rules, regulations, guides
and guidance, such as 21C.F.R. parts 210 and 211 and parts 600 and
610.
1.14. CMC means the Chemistry, Manufacturing, and Controls content of a
submission to a HEALTH AUTHORITY.
1.15. COA means a Certificate of Analysis, a document listing testing
parameters, specifications and test results (in a format and detail as
listed in EXHIBIT 3).
1.16. COC means a Certificate of Compliance confirming compliance with cGMP
regulations and signed by BI Austria's authorized Qualified Person,
the Head of Production and the Head of Quality Assurance (in a format
and such detail as listed in EXHIBIT 4).
1.17. CONFIDENTIAL INFORMATION means any proprietary INFORMATION (a)
disclosed by one Party to the other (including without limitation,
such INFORMATION as was disclosed under the Confidential
Non-Disclosure Agreement dated June 5, 1998, between InterMune and
Xxxxxx+Co Ges mbH (now BI Austria), or (b) developed by either Party
pursuant to this Agreement, except for INFORMATION which (i) is
already in the public domain at the time of its disclosure to the
receiving Party; (ii) becomes part of the public domain through no
wrongful action or omission of the receiving Party after disclosure to
the receiving Party; (iii) is already known to the receiving Party at
the time of disclosure as evidenced by the receiving Party's written
records; or (iv) is independently developed by the receiving Party
without the use or application of the disclosing Party's proprietary
information.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
4 of 66
1.18. CONTROLLED means, with respect to any material, INFORMATION or
intellectual property right, possession of the ability by a Party to
grant access, a license, or a sublicense to such material, INFORMATION
or intellectual property right as provided for herein without
violating an agreement with a Third Party as of the time such Party
would be first required hereunder to grant the other Party such
access, license or sublicense.
1.19. FDA means the United States Food and Drug Administration and any
successor agency thereto.
1.20. FD&C ACT means the United States Food, Drug & Cosmetic Act as amended
from time to time and any supplements thereunder, and any equivalent
regulation of any HEALTH AUTHORITIES.
1.21. FILLING SITE CHANGE means the transfer of the filling and finishing
part of the MANUFACTURING PROCESS from BI Austria to BI Pharma KG.
1.22. FINAL RELEASE means the release of PRODUCT by InterMune or its
licensees for clinical trial use or market supply, as applicable.
1.23. GENENTECH PRODUCT means the formulation of INTERFERON GAMMA 1b
manufactured in the US by Genentech for sale under the trademark
ACTIMMUNE and approved by the FDA for the treatment of Chronic
Granulomatous Disease.
1.24. GENENTECH TECHNOLOGY means all INFORMATION relating to the
manufacture, use or sale of INTERFERON GAMMA 1b that is licensed to
either Party pursuant to an agreement with Genentech, including
without limitation the MANUFACTURING PROCESS, and all patents and
patent applications covering such INFORMATION.
1.25. HEALTH AUTHORITIES mean all regulatory authorities having jurisdiction
over the manufacture, use and/or sale of the PRODUCT in the TERRITORY,
including but not limited to the FDA.
1.26. INFORMATION means (a) techniques, data, inventions, practices,
methods, knowledge, know-how, skill, experience, test data (including
pharmacological, toxicological and clinical test data), analytical and
quality control data, regulatory submissions, correspondence and
communications, marketing, pricing, distribution, cost, sales,
manufacturing, patent and legal
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
5 of 66
data or descriptions, compositions of matter, assays and biological
materials, and (b) all intellectual property rights in and to any of
the foregoing.
1.27. INTERFERON-GAMMA 1B means the recombinant human Interferon-Gamma 1b
derived from a [ * ], and that is the active ingredient in
ACTIMMUNE-Registered Trademark-. The relevant amino acid sequence is
set forth in EXHIBIT 5.
1.28. INTERMUNE'S TECHNOLOGY means all INFORMATION that is CONTROLLED by
INTERMUNE during the term of this Agreement that is related to or
useful in BI Austria's manufacture of PRODUCT hereunder, and all
patents and patent applications covering any of the foregoing;
provided that "INTERMUNE'S TECHNOLOGY" shall not include any
INFORMATION (i) owned or CONTROLLED by BI Austria prior to the
Effective Date, (ii) conceived of, or reduced to practice or acquired
by BI Austria outside of this Agreement during the term of this
Agreement, or (iii) the GENENTECH TECHNOLOGY.
1.29. MCB means the original Master Cell Bank derived from the [ * ] and
established by Genentech.
1.30. MANUFACTURING PROCESS means the process for fermentation,
purification, filling, labeling and packaging of BBS and PRODUCT, as
described in EXHIBIT 6.
1.31. MATERIAL SUPPLY BREACH means a failure of BI Austria: (a) to supply to
InterMune at least [ * ] of InterMune's binding forecasted
requirements of PRODUCT (or actual orders, if less) that are due for
delivery by the designated delivery date during the then-current
calendar quarter; or (b) to repeatedly [ * ] materially violate
against cGMP, as described in Sections 5.6 and 5.7.
1.32. PRODUCT shall mean a finished product consisting of formulated
INTERFERON GAMMA 1b filled into the designated containers for clinical
supply and for market supply, as described in EXHIBIT 7, or shall mean
a finished product of formulation buffer filled into the designated
containers for clinical supply (placebo).
1.33. PROJECT MANAGER means the responsible person designated by each Party
to be responsible for the communication of all information concerning
this Agreement. As of the Effective Date, the person designated as
InterMune's PROJECT MANAGER and the person designated as BI Austria's
PROJECT MANAGER are listed in EXHIBIT 8. Either Party may
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
6 of 66
change its own designated PROJECT MANAGER by providing written notice
thereof to the other Party.
1.34. PRODUCT SPECIFICATIONS mean the specifications for the PRODUCT as set
forth in EXHIBIT 9, or as otherwise agreed by the Parties in writing.
1.35. PROJECT TEAM means the team as listed in EXHIBIT 8 and described in
Section 6.1.
1.36. QUALITY ASSURANCE REQUIREMENTS mean InterMune's quality assurance
requirements as set forth in EXHIBIT 10, as may be amended from time
to time by written agreement of the Parties.
1.37. RELEASE means the release of the PRODUCT by BI Austria to InterMune or
its designee.
1.38. SERVICES mean the services to be performed by BI Austria and BI Pharma
KG in connection with establishing comparability between the GENENTECH
PRODUCT and the BI PRODUCT for cGMP purposes, and preparing BI Austria
to be approved by the FDA as a cGMP manufacturer of the PRODUCT, as
further described in EXHIBIT 11. EXHIBIT 11 also includes the costs
for the SERVICES. The timeline within which BI Austria and BI Pharma
KG intend to perform the SERVICES is described in EXHIBIT 12.
1.39. STEERING COMMITTEE means the committee as listed in EXHIBIT 13 and as
further described in Section 6.2.
1.40. TERRITORY means the US, Japan and all additional territories,
including but not limited to Canada, as to which InterMune has or may
acquire the right to manufacture, use or sell INTERFERON GAMMA 1b
products during the term of this Agreement.
1.41. US means the United States of America.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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2. DATA TRANSFER AND PRODUCT COMPARISON
2.1. INTERMUNE'S TASKS AND RESPONSIBILITIES
2.1.1. DOCUMENTATION
InterMune shall provide BI Austria with the relevant
documentation that is reasonably available to InterMune
concerning the GENENTECH PRODUCT and its manufacture by
Genentech, including amendments and currently used batch
records and testing procedures and all material correspondence
with the HEALTH AUTHORITIES in the US as listed in EXHIBIT 14.
The Parties acknowledge that BI Austria is already in receipt
of most of the relevant documentation.
2.1.2. MATERIAL
InterMune shall provide BI Austria with original [ * ]
vials from Genentech and samples of BBS manufactured by
Genentech, as well as of the final labeled product
ACTIMMUNE-Registered Trademark-, in such reasonable amounts
and at such times as agreed by the Project Team. InterMune
shall also supply BI Austria, as reasonably requested and
in reasonable amounts, with reference material, antibodies
and reagents for analytical testing, and all other material
reasonably available to InterMune and reasonably requested
by BI Austria that may be suitable as a basis for
comparison between the GENENTECH PRODUCT and the BI PRODUCT.
2.1.3. DATA
InterMune shall also provide to BI Austria, as reasonably
requested, all technical data and equipment specifications
reasonably available to InterMune that are used in the
manufacture of the GENENTECH PRODUCT in the US.
2.1.4. SUPPORT
InterMune shall timely send all documentation, and otherwise
timely provide all information and other assistance,
reasonably requested by BI Austria for use under this
Agreement. InterMune shall provide such reasonable technical
support at its own
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
8 of 66
expense, which support shall include access to InterMune's
expert personnel upon reasonable notice and at such reasonable
times as the Parties may agree.
2.1.5. CONTACT WITH HEALTH AUTHORITIES
2.1.5.1. InterMune, as the license holder for the
GENENTECH PRODUCT in the US, shall have the
overall responsibility regarding all contacts
with the HEALTH AUTHORITIES and shall be solely
responsible for filing all regulatory documents
required by any HEALTH AUTHORITIES, such as any
amendments to the BLA for the GENENTECH PRODUCT.
BI Austria shall support InterMune in all
matters regarding the manufacturing and quality
control of PRODUCT as reasonably requested by
InterMune, but InterMune shall be the leading
Party, responsible for co-ordination of all
regulatory matters.
2.1.5.2. InterMune will notify BI Austria in due time,
but in no event later than five (5) business
days in advance of any meeting with any HEALTH
AUTHORITIES with regard to manufacture, supply
and quality control of the PRODUCT manufactured
by BI Austria or BI Pharma KG under this
Agreement. BI Austria shall have the right to
participate in such meetings with such HEALTH
AUTHORITIES during the portion of such meetings
relating to BI Austria's or BI Pharma KG's
manufacture, supply and quality control of the
PRODUCT.
2.1.5.3. BI Austria will be responsible for drawing up
the annual report required by the HEALTH
AUTHORITIES reasonably in advance of the due
date, and will be responsible of matters
regarding the manufacture of PRODUCT. InterMune
shall submit such report to the HEALTH
AUTHORITIES and shall provide BI Austria with a
copy of the finally submitted report.
2.1.6. SHIPMENT OF MATERIAL BY INTERMUNE
All material, e.g. samples, sent by InterMune to BI Austria
shall be made by shipment from InterMune's or Genentech's
facility to BI Austria's facility in Vienna. Shipping costs
including insurance will be borne by InterMune, and risk of
loss in transit shall lie with InterMune.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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2.2. BI AUSTRIA'S TASKS AND RESPONSIBILITIES
2.2.1. COMPARISON OF DOCUMENTATION AND MATERIALS
2.2.1.1. BI Austria shall evaluate and compare all
documentation and other materials relating to
the manufacture and testing of the GENENTECH
PRODUCT with all relevant documentation and
other materials relating to the manufacture and
testing of the BI PRODUCT that is necessary to
demonstrate comparability between such Genentech
documentation, as listed in EXHIBIT 14, and such
BI Austria documentation.
2.2.1.2. BI Austria shall also carry out an analytical
comparison of BBS and GENENTECH PRODUCT
manufactured by Genentech and of BBS and BI
PRODUCT manufactured by BI Austria and BI Pharma
KG based on a mutually agreed protocol as listed
in EXHIBIT 15.
2.2.2. PRODUCTION RUNS
Subject to Section 2.2.3, BI Austria shall carry out three (3)
production runs of PRODUCT in order to obtain APPROVAL in the
US as a cGMP manufacturer of BBS, and to have BI Pharma KG
obtain APPROVAL in the US as a cGMP manufacturer of PRODUCT.
BBS and PRODUCT derived from these runs shall be used for
evidencing comparability between the GENENTECH PRODUCT and the
BI PRODUCT. The costs of these runs are listed in EXHIBIT 11
and shall be borne by InterMune.
2.2.3. ADDITIONAL RUNS
If any HEALTH AUTHORITIES request further analytical testing
and/or production runs in addition to those described in
EXHIBIT 11, BI Austria shall perform such testing and/or
production runs as requested by InterMune. The cost of such
additional testing and/or production runs will be borne by
InterMune, subject to InterMune's prior written approval of
such costs, unless the additional analytical testing and/or
production runs are due to negligence on BI Austria's or BI
Pharma KG's part.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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2.2.4. ADDITIONAL DOCUMENTATION
If any HEALTH AUTHORITIES request that InterMune or BI Austria
provide, in connection with BI Austria's and/or BI Pharma KG's
receipt of approval as a manufacturer of PRODUCT hereunder,
further documentation regarding the manufacture of PRODUCT in
addition to the documentation as foreseen under the SERVICES
(e.g. certain reports), BI Austria will provide such
documentation to InterMune for provision to such HEALTH
AUTHORITIES as soon as reasonably possible. Such additional
documentation may be either (a) product and/or process-related
or (b) facility-related (e.g. infrastructure, utilities,
personnel, training etc.). The cost of such additional product
and/or process-related documentation shall be borne by
InterMune unless such additional documentation is due to
negligence on BI Austria's or BI Pharma KG's part. The cost of
such additional facility-related documentation shall be borne
by BI Austria.
2.2.5. REGULATORY SUPPORT
2.2.5.1. BI Austria shall provide all site-relevant
documentation (both from itself and from BI
Pharma KG) and all data relevant for compiling
the CMC section necessary for InterMune's
drafting of the BLA supplement required by the
FDA due to the change of manufacturer for the
GENENTECH PRODUCT. BI Austria agrees to
co-operate with InterMune in obtaining and
maintaining all US governmental approvals and
registrations relevant to the CMC section of the
registration dossier (and their foreign
equivalents) as requested by InterMune.
2.2.5.2. The Parties shall consult with each other
concerning the scope and content of all
regulatory filings, and shall jointly define the
requirements for the necessary PRODUCT
registration with the FDA so that BI Austria
shall be able to fulfill its obligations under
this Agreement with respect to the CMC portion
of such PRODUCT registration.
2.2.6. FORMAT AND CONTENT OF DOCUMENTS
BI Austria's Quality Management System demands a special
format for certain documents (i.e. batch records, testing
procedures, technical reports) which is binding.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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For those documents where a binding format is not obligatory
the Parties shall agree in writing on a master format. With
respect to the dates contained in these documents, and in
particular in all reports and when dates occur in connection
with signatures, the European writing style shall apply. The
order shall be as follows: dd / mm / yy (day/month/year).
2.2.7. STANDARD OF PERFORMANCE
BI Austria shall diligently perform the SERVICES, and shall
ensure that BI Pharma KG diligently performs the SERVICES, in
a manner consistent with good scientific / regulatory /
business practices. InterMune acknowledges that the SERVICES
are of biological nature and therefore neither success nor
commercial exploitability can be guaranteed by BI Austria.
3. MANUFACTURE AND SUPPLY
3.1. GENERAL
3.1.1. [ * ] for use and sale in the TERRITORY, BBS or PRODUCT for
use in the treatment or prevention of any human disease or
condition except for the treatment or prevention of any
type of cardiac or cardiovascular disease or condition.
[ * ] BBS or PRODUCT for use in the treatment of any human
disease or condition, except for the treatment or
prevention of any type of cardiac or cardiovascular
condition, [ * ]for use and/or sale in the TERRITORY [ * ]
InterMune's clinical trial supply, and from the time BI
Austria and BI Pharma KG are approved by the HEALTH
AUTHORITIES also [ * ] for PRODUCT in the TERRITORY for the
term of this Agreement, subject to Section 3.7.
3.1.2. All BBS manufactured by BI Austria hereunder, and all
PRODUCT manufactured and supplied to InterMune by BI
Austria hereunder, shall be manufactured and supplied in
accordance with the BBS SPECIFICATIONS and PRODUCT
SPECIFICATIONS, the cGMP requirements, the QUALITY
ASSURANCE REQUIREMENTS as listed in EXHIBIT 10 and all
applicable laws, regulations and ordinances of the
jurisdiction in which such manufacture occurs.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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3.1.3. BI Austria shall manufacture BBS according to the BULK
SPECIFICATIONS. Until the FILLING SITE CHANGE is complete,
BI Austria shall manufacture PRODUCT according to PRODUCT
SPECIFICATIONS for clinical supply only. Upon completion of
the FILLING SITE CHANGE and upon receipt of FDA APPROVAL of
BI Austria's facility as well as BI Pharma KG's facility,
BI Austria shall also manufacture PRODUCT for market
supply. BBS for clinical and market supply shall be
manufactured at BI Austria and transferred to BI Pharma KG
for vialing, labeling (but only for market supply) and
packaging. Manufacturing and filling of vials, labeling
(but only for market supply) as well as the packaging and
storing of PRODUCT shall be in accordance with the PRODUCT
SPECIFICATIONS, the cGMP requirements, the QUALITY
ASSURANCE REQUIREMENTS as listed in EXHIBIT 10 and all
applicable laws, regulations and ordinances of the
jurisdiction in which such manufacturing and/or filling
occurs. Notwithstanding the fact that BI Austria takes BI
Pharma KG as a toll manufacturer for filling, labeling (for
market supply) and packaging of PRODUCT, BI Austria takes
responsibility for the manufacture and supply of PRODUCT to
InterMune in accordance with the terms and conditions of
this Agreement.
3.2. FORECASTS
3.2.1. [ * ] prior to the first delivery date of PRODUCT for
market supply and [ * ] prior to the first delivery date of
PRODUCT for clinical supply, unless otherwise agreed,
InterMune shall provide a rolling forecast for the next
[ * ]. The first [ * ] of such forecast shall be firm
(EXHIBIT 16, [ * ]). For [ * ] InterMune can reduce its
forecast by [ * ], and may increase its forecast [ * ] will
constitute a non-binding forecast [ * ]. After the first
forecast has been submitted by InterMune to BI Austria,
successive forecasts shall be submitted on a quarterly
basis at the latest on every first day of every new
calendar quarter. InterMune agrees to order the PRODUCT in
filling lot quantities or multiples thereof (available lot
sizes are [ * ], or any other then available lot sizes).
Following BI Austria's and BI Pharma KG's FDA approval to manufacture
PRODUCT for market supply, InterMune shall order the requested amounts
of PRODUCT. In any case the [ * ].
3.2.2. If InterMune requires more PRODUCT than is set forth in the
current firm forecast, BI Austria shall use commercially
reasonable efforts in good faith to supply InterMune with
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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PRODUCT as requested; PROVIDED THAT for the amounts of
PRODUCT in excess of such forecast which BI Austria is
unable to supply, despite such commercially reasonable
efforts, InterMune may use a secondary source manufacturer
in accordance with the procedures set forth in Section 3.7.
3.2.3. If InterMune reduces the forecast for [ * ]by an amount in
excess of [ * ] percent (net of any increases in actual
orders for these [ * ]), then InterMune shall be [ * ]
which was [ * ] of the [ * ] at the [ * ] of the [ * ] of
the [ * ].
3.2.4. Notwithstanding the provisions stated in 3.2.1. for
planning purposes at BI Pharma KG InterMune shall provide
BI Austria [ * ]prior to the first delivery date of PRODUCT
as not agreed otherwise a rolling forecast for the next
[ * ] upon completion of the FILLING SITE CHANGE. InterMune
will be immediately informed by BI Austria of date of
completed FILLING SITE CHANGE. For all further requirements
all terms and conditions as stated in 3.2.1. shall apply.
3.2.5. In the event that the FDA approval process for the PRODUCT
is unexpectedly delayed, and/or the PRODUCT fails to pass
clinical trials, InterMune shall have no further ordering
and purchase obligations under Sections 3.2.1. and 3.2.3.
Only in this event even firm forecasts can be canceled,
provided that InterMune shall remain responsible for those
reasonable, documented, financial obligations which BI
Austria and/or BI Pharma KG have incurred due to (a) the
timely allocation of resources for the manufacture of BBS
and PRODUCT, (b) equipment for manufacture of BBS / PRODUCT
already ordered and not otherwise cancelable, or (c) other
non-refundable amounts already expended by BI Austria
and/or BI Pharma KG in good faith reliance on the cancelled
forecast.
3.3. PURCHASE ORDERS
3.3.1. All purchases of PRODUCT hereunder shall be made pursuant
to written purchase orders provided to BI Austria by
InterMune. To the extent that the terms of a purchase order
or of BI Austria's or BI Pharma KG's "GENERAL CONDITIONS OF
SALE" are inconsistent with the terms of this Agreement,
this Agreement shall prevail.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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3.3.2. BI Austria shall guarantee that at the date of FINAL
RELEASE all PRODUCT supplied to InterMune shall have a
minimum residual shelf life of not less than [ * ] of
PRODUCT shelf life, provided that InterMune shall strictly
fulfill its contractual timelines regarding FINAL RELEASE
as set forth in Sections 3.5 and 5.3.
3.3.3. BI Austria shall ship all PRODUCT as set forth in Section
3.4 by the date and in the quantities specified in the
applicable purchase order. BI Austria shall be obligated to
accept any purchase order within the range of permitted
variation in the forecasted quantities as set forth in
Section 3.2.1. and 3.2.2. Any other purchase order shall be
binding on BI Austria only if it is accepted by BI Austria,
which acceptance shall not be unreasonably withheld. If BI
Austria does not accept such a purchase order, then
InterMune may use a secondary source manufacturer for such
purchase order in accordance with the procedures set forth
in Section 3.7.
3.3.4. InterMune shall be obligated to buy and BI Austria shall be
obligated to sell only the quantities of PRODUCT which are
subject to a purchase order accepted by BI Austria. Any
purchase order (or portion thereof) for which InterMune has
not received a written rejection from BI Austria within
fifteen (15) business days of BI Austria's receipt of such
purchase order shall be deemed accepted by BI Austria.
3.4. SHIPMENT OF PRODUCT AND MATERIAL BY BI AUSTRIA
3.4.1. The PRODUCT and all material (e.g. samples) shall be
shipped [ * ] either BI Pharma KG, FRG-88397 Biberach an
der Riss, Germany or BI Austria's facility in Vienna,
Austria, as the case may be, to InterMune or as directed by
InterMune, in accordance with Incoterms 1990 as published
by the International Chamber of Commerce. InterMune's
designated carrier shall be used to ship PRODUCT to the
site designated by InterMune. Risk of loss in transit by
InterMune's designated contract carrier shall lie with
InterMune, except where such loss is caused by BI Austria's
or BI Pharma KG's negligence.
3.4.2. BI Austria will provide or will have provided assistance to
InterMune regarding necessary procedures for exportation
and/or importation of PRODUCT.
3.5. TESTING AND REJECTION
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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3.5.1. Within [ * ] business days of its receipt of PRODUCT at
such destination as may be designated by InterMune,
InterMune may perform such tests and samplings as are
appropriate to determine whether such PRODUCT meets the
applicable PRODUCT SPECIFICATIONS. If InterMune refuses
acceptance of PRODUCT, then InterMune shall inform BI
Austria in writing within [ * ]further business days of any
aspect in which such PRODUCT fails to conform to the
PRODUCT SPECIFICATIONS. If BI Austria does not receive such
a notice within [ * ] business days of InterMune's receipt
of such PRODUCT, then InterMune shall be deemed to have
accepted the PRODUCT; provided that InterMune shall have
the right to revoke its acceptance of such goods if it
later discovers latent defects not reasonably discoverable
at the time of receipt.
3.5.2. If BI Austria receives a notice from InterMune pursuant to
Section 3.5.1 that InterMune does not accept any PRODUCT
supplied hereunder, then BI Austria shall immediately start
re-testing the PRODUCT using the retained samples in order
to evaluate process issues and other reasons for such
non-compliance.
3.5.3. Regardless of whether BI Austria agrees with InterMune's
rejection of such PRODUCT, if requested in writing by
InterMune, BI Austria shall use reasonable efforts to
promptly replace such allegedly defective PRODUCT, the
costs of which shall be borne as set forth in Section 3.5.4.
3.5.4. In the event that BI Austria's re-testing does not verify
InterMune's reasons for rejecting such PRODUCT, the Parties
shall mutually agree on an independent laboratory that
shall determine by applying validated product-specific
analytical methods whether such PRODUCT meets the PRODUCT
SPECIFICATIONS. The conclusions of this independent
laboratory shall be binding upon both Parties. If such
laboratory determines that such PRODUCT does meet the
PRODUCT SPECIFICATIONS, then InterMune shall bear the costs
for such independent laboratory and for any replacement
PRODUCT manufactured and supplied to InterMune by BI
Austria pursuant to Section 3.5.3. If such laboratory
determines that such PRODUCT does not meet the PRODUCT
SPECIFICATIONS, then BI Austria shall bear the costs for
such independent laboratory and for any such replacement of
PRODUCT.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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3.5.5. Neither Party may destroy any PRODUCT alleged not to meet
the PRODUCT Specifications until the independent laboratory
determines whether such PRODUCT meets the applicable
PRODUCT SPECIFICATIONS and provides written notification to
the Parties with respect to such determination, unless BI
Austria accepts InterMune's basis for such rejection.
Thereafter, BI Austria shall have the obligation to destroy
or have destroyed, at its cost, all such rejected PRODUCT.
Upon BI Austria's written request and at BI Austria's cost,
InterMune shall either destroy or return to BI Austria any
rejected PRODUCT. The Parties agree that in the event of
destruction of PRODUCT, the method of such destruction
shall be in compliance with all applicable laws, rules and
regulations.
3.5.6. Claims on account of quantity, loss or damages to PRODUCT
(other than claims that such PRODUCT does not meet the
PRODUCT SPECIFICATIONS and latent defects not reasonably
detectable upon inspection) will be dispatched by InterMune
in writing within [ * ] business days following receipt
thereof. BI Austria shall use reasonable efforts to replace
the quantity of goods which such claims apply, which
replacement shall be at InterMune's expense unless such
claims are due to the negligence of BI Austria.
3.6. INCREASE OF MANUFACTURING CAPACITY
3.6.1. At BI Austria's facility an additional production line is
currently under construction. Validation of this separated
cGMP fermentation production lines within a completely
separated containment is intended to be completed by [ * ]
for any reason including but not limited to the amount of
BBS to be manufactured, when to have the [ * ].
3.6.2. BI Austria guarantees to have manufactured at BI Pharma KG
a minimum of [ * ] vials per year. InterMune presumes that
the amount of vials requested per year might exceed [ * ]
vials. Should it become at any time apparent that a higher
PRODUCT demand is necessary InterMune will notify BI
Austria thereof. BI Austria shall inform as soon as
reasonably possible InterMune of the respective costs for
guaranteeing the appropriate reserved capacity for
manufacturing the amount exceeding [ * ] vials. Upon
agreement on the costs BI Austria shall reserve the
capacity needed for the increased demand of PRODUCT.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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Should it become at any time apparent that manufacturing
capacity at BI Austria for cell paste and BBS equivalent to
at least [ * ] vials per year would not be feasible, BI
Austria will notify InterMune thereof.
3.7. SECOND SOURCE MANUFACTURER
3.7.1. BI Austria acknowledges that it is critical that InterMune
be ensured continuity of supply of PRODUCT for use in
clinical trials and market supply. BI Austria shall ensure
continuity of supply of PRODUCT for use in clinical trials
and market supply. Nevertheless, due to the potentially
growing market demand of PRODUCT, BI Austria's ability to
manufacture and supply PRODUCT shall be carefully observed.
Should at any time BI Austria have any indication that
continuity of supply can not be ensured, BI Austria shall
immediately inform InterMune thereof in writing. In this
event the matter would be immediately forwarded to the
STEERING COMMITTEE to discuss second source manufacture of
PRODUCT reasonably and in good faith.
3.7.2. In the event the STEERING COMMITTEE decides that it is
appropriate for InterMune to establish a second source
manufacturer, InterMune agrees to provide the first
opportunity to qualify as a second source manufacturer for
PRODUCT to a BI Austria AFFILIATE. If such an AFFILIATE is
- as foreseeable - unable to supply InterMune's PRODUCT
requirements then InterMune shall be free to choose an
alternate supplier. In this case BI Austria shall assist
InterMune in transferring the MANUFACTURING PROCESS to a
third party supplier by providing reasonable technical
assistance and documentation as necessary for a transfer to
a party well skilled in the manufacture of such biotech
products at InterMune's cost.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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3.8. MATERIAL SUPPLY BREACH
3.8.1. In the event of a MATERIAL SUPPLY BREACH, InterMune shall
provide BI Austria written notification of such MATERIAL
SUPPLY BREACH. Upon BI Austria's receipt of such notice and
failure to cure such MATERIAL SUPPLY BREACH within the
timetable and activity plan agreed upon the Parties to cure
such MATERIAL SUPPLY BREACH, InterMune shall have the right
to purchase from a second source manufacturer, to be agreed
upon within the STEERING COMMITTEE in accordance with
Section 3.7, such amounts of PRODUCT as necessary to offset
BI Austria's shortfall in fulfilling InterMune's purchase
orders for such PRODUCT (or the anticipated shortfall, in
the event of repeated [ * ]material violation against cGMP).
In the event, that
i) a BI Austria AFFILIATE can not qualify as a
second source manufacturer for PRODUCT or
ii) in the event such a BI Austria AFFILIATE is - as
foreseeable -unable to supply InterMune's
PRODUCT requirements and
iii) provided that PRODUCT supply as requested by
InterMune by a different second source
manufacturer, a company experienced in
manufacturing of biopharmaceuticals derived from
[ * ], and selected by InterMune could
demonstrably take place earlier than a MATERIAL
SUPPLY BREACH by BI Austria could be remedied,
BI Austria shall assist InterMune as requested
in transferring the MANUFACTURING PROCESS to
such a second source supplier, to be selected by
InterMune by providing reasonable technical
assistance and documentation relating to the
manufacture, testing and supply of BBS and the
PRODUCT as necessary at BI Austria's cost. Such
second source manufacturer would bear
responsibility for putting the MANUFACTURING
PROCESS in place. The [ * ]reasonable technical
assistance shall [ * ].
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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3.8.2. In the event that BI Austria reasonably anticipates that
there is a substantial likelihood that a MATERIAL SUPPLY
BREACH will occur, BI Austria shall promptly notify
InterMune in writing thereof. Upon receipt of such notice,
the Parties shall promptly confer to discuss the
circumstances and magnitude of such potential MATERIAL
SUPPLY BREACH, and to determine in good faith whether there
are any reasonable steps that BI Austria could take to
avoid such MATERIAL SUPPLY BREACH. If InterMune is not
reasonably satisfied that BI Austria will be able to avoid
such MATERIAL SUPPLY BREACH, then InterMune shall forward
this issue to the STEERING COMMITTEE to determine whether
it is necessary or desirable to establish a second source
manufacturer in accordance with Section 3.7.
4. PRICES AND PAYMENT
4.1. The prices to be paid by InterMune for the SERVICES and PRODUCT
provided hereunder have been agreed to by the Parties and are listed
in EXHIBIT 11 and EXHIBIT 17, respectively. The price for the
SERVICES and PRODUCT will be adjusted year by year in accordance
with the [ * ]. (By way of example, the [ * ].) All payments
hereunder shall be made in Austrian Shilling or in Euro. If the
Austrian Shilling is replaced by the Euro and therefore no longer
available, payments becoming due thereafter shall be made in Euro
calculated at the official exchange rate.
4.2. [ * ] will be [ * ] which are [ * ] at the time such [ * ] to have
any such [ * ] selected by [ * ] which [ * ] shall [ * ]on
verification concerning the [ * ] shall provide [ * ] with [ * ]
days' notice of any [ * ].
4.3. The price for the SERVICES and purchase price for PRODUCT shall be
paid to BI Austria no later than [ * ] days after the date that BI
Austria's invoice is received by InterMune.
4.3.1. Payment of the invoice amounts shall be made in Austria,
[ * ], into an account with such Austrian credit
institution as shall be notified by BI Austria to InterMune
from time to time.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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4.3.2. All payments owed to BI Austria by InterMune on the basis of
accounts rendered shall be made in such a way that [ * ] shall
be [ * ] that are [ * ] on such [ * ]. In the event of a
default in payment for whatever reason, default interest at a
rate of [ * ] p.a. shall be payable on the outstanding amount
due. BI Austria reserves the right to claim any damage
exceeding such amount that shall have been caused by such
delay, subject to Section 11.1.
4.4. As [ * ] for [ * ] for the [ * ] shall [ * ] within [ * ]business
days of the Effective Date an [ * ] by a [ * ] with a [ * ] in the
[ * ] which is in accordance with a [ * ] of the [ * ] for the [ * ]
as listed in [ * ] shall provide such [ * ] at its [ * ] shall be
entitled to [ * ] arising with respect to the [ * ].
5. QUALITY ASSURANCE AND COMPLIANCE WITH LAW
5.1. RELEASE OF PRODUCT
5.1.1. BI Austria shall be responsible for the RELEASE of PRODUCT
according to the PRODUCT SPECIFICATIONS, the cGMP
requirements, the QUALITY ASSURANCE REQUIREMENTS as listed in
EXHIBIT 10 and all applicable Austrian and German laws. BI
Austria shall certify in writing that each shipment lot of
PRODUCT was produced and tested in compliance with (i) the
SPECIFICATIONS, (ii) the cGMP requirements (iii) QUALITY
ASSURANCE REQUIREMENTS and (iv) all applicable laws,
regulations and ordinances of the jurisdiction in which such
manufacture occurs.
5.1.2. BI Austria shall provide to InterMune, through BI Pharma KG,
QUALITY ASSURANCE REQUIREMENTS as listed in EXHIBIT 10
including but not limited to a COA and COC signed by the
appropriate personnel as defined in BI Austria's Quality
Management System for each shipment lot of PRODUCT from BI
Pharma KG's manufacture site in Biberach, Germany, in order to
prove BI Austria's compliance with the Article 5.1.1.
5.2. STORAGE OF RECORDS AND BATCH SAMPLES
5.2.1. BI Austria shall maintain in compliance with cGMP standards
all batch samples and all records required by law or as
otherwise mutually agreed in writing by the Parties (i.e.
batch records, analytical raw data) necessary to evidence
compliance with all its
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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obligations under this Agreement and relating to the
manufacture of the BBS and of PRODUCT. The documentation
concerning manufacture of BBS shall be stored at BI Austria
and concerning manufacture of PRODUCT shall be stored in
Biberach upon completion of FILLING SITE CHANGE. Storage of
retained samples of BBS as well as PRODUCT shall be at BI
Austria.
5.2.2. Copies of all documentation and information relating to the
manufacture, processing, packaging and shipping of PRODUCT
and/or required to support InterMune's BLA or other regulatory
submissions, including but not limited to information relating
to batch records, methods, equipment and the facility, will be
provided by BI Austria to InterMune for review and inclusion
as necessary in InterMune's regulatory submissions.
5.2.3. All such samples and records shall be maintained for a period
not less than five (5) years from the date of expiration of
each batch of PRODUCT to which such samples and records
pertain, or such longer period as may be required by local law
and the rules or regulations of the FDA or other applicable
HEALTH AUTHORITIES. Following the expiration of such required
retention period, prior to the destruction of any such sample
or record, BI Austria shall give written notice thereof to
InterMune, and InterMune shall have the right to request,
receive and retain such samples and records with no further
compensation to BI Austria.
5.3. FINAL RELEASE
FINAL RELEASE of PRODUCT supplied by BI Austria and/or BI Pharma KG
hereunder for use in humans shall solely be made by and under the
responsibility of InterMune.
5.4. THIRD PARTY SERVICES
Except as specifically provided for herein, BI Austria will not
contract out to any third party any part of the SERVICES or the
manufacture and testing of BBS or PRODUCT, without prior written
approval from InterMune, which shall not be unreasonably withheld.
5.5. CONSENT TO CHANGES
BI Austria will not make any changes to BI Austria's, and shall ensure
that BI Pharma KG shall not make any changes to BI Pharma KG's,
respective manufacturing facilities, equipment,
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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testing procedures, validation, suppliers of raw materials and
components or documentation systems that are solely related to
the PRODUCT and having a non-trivial impact on the PRODUCT,
without the prior written consent of InterMune and solely as
is permitted by cGMP. In the event that a supplier of raw
material is unable to deliver the respective raw material in
time for scheduled manufacturing BI Austria is free to choose
another supplier, provided that such supplier supplies such
raw material that fully meets the respective raw material
specification, and subject to BI Austria's providing InterMune
prior written notice thereof.
5.6. INSPECTIONS BY HEALTH AUTHORITIES
5.6.1. BI Austria shall secure that during APPROVAL inspections at BI
Austria's and/or BI Pharma KG's facilities by any applicable
HEALTH AUTHORITIES, BI Austria shall give InterMune prior
written notice thereof promptly following BI Austria's receipt
of notice of such inspection, so that representatives of
InterMune may attend and participate in such inspections, for
example, to answer PRODUCT and clinical trial related
questions.
5.6.2. BI Austria shall advise, and shall ensure that BI Pharma KG
shall advise, InterMune in writing immediately of any requests
by any applicable HEALTH AUTHORITIES for inspections at either
of BI Austria's or BI Pharma KG's facilities, but in any
event, no later than ten (10) business days prior to the
scheduled date of such inspection. Upon reasonable notice,
InterMune or its representatives may attend only such portions
of such inspections or audits that deal with PRODUCT related
issues, due to BI Austria's other secrecy obligations. Access
to such facilities may be subject to reasonable restrictions
customarily placed upon visitors to the site.
5.6.3. BI Austria also agrees to notify InterMune within four (4)
business days of any written or oral inquiries, notifications,
or inspection activity by any HEALTH AUTHORITIES (or any third
party authorized by the HEALTH AUTHORITIES) in regard to
PRODUCT. BI Austria shall provide a reasonable description to
InterMune of any such inquiries, notifications or inspections
promptly (but in no event later than ten (10) business days)
after such visit or inquiry. BI Austria shall furnish to
InterMune (a) within four (4) business days after receipt, any
report or correspondence issued by the HEALTH AUTHORITIES (or
a third party authorized by a HEALTH AUTHORITIES)
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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in connection with such visit or inquiry, including but not
limited to, any FDA Form 483 (List of Inspectional
Observations) or warning letter, and (b) not later than five
(5) business days prior to the time it provides to a HEALTH
AUTHORITY, copies of any and all proposed written responses or
explanations relating to items set forth above (each, a
"Proposed Response"), in each case purged only of trade
secrets or other confidential or proprietary information of BI
Austria that are unrelated to its obligations under this
Agreement or are unrelated to PRODUCT. BI Austria shall
discuss with InterMune any comments provided by InterMune on
the Proposed Response; provided that InterMune shall have the
final decision with respect to those portions of the final
written response or explanation to be provided to the HEALTH
AUTHORITIES that relate to PRODUCT manufactured hereunder.
After the filing of a response with the appropriate HEALTH
AUTHORITIES, BI Austria will notify InterMune of any further
contacts with the HEALTH AUTHORITIES relating to BI Austria's
manufacture of PRODUCT hereunder.
5.6.4. BI Austria shall promptly correct, and shall ensure that BI
Pharma KG shall promptly correct, any facility-related
violations or deficiencies promptly at its own expense.
Equipment, system and process-related violations or
deficiencies that are solely PRODUCT-related shall be
corrected promptly by BI Austria or BI Pharma KG,
respectively, at InterMune's cost.
In the event such corrections will not only be necessary for
PRODUCT but as well for BI PRODUCT the appropriate allocation
of the related costs between the Parties shall be determined
by the PROJECT TEAM.
5.7. AUDITS BY INTERMUNE
5.7.1. InterMune shall have the right to inspect and audit both of BI
Austria's and BI Pharma KG's manufacturing facilities and
records for regulatory compliance. These audits shall occur
annually upon reasonable notice, and more frequently for good
and reasonable cause. BI Austria shall respond in writing to
InterMune regarding any items of non-compliance with cGMP
identified by InterMune during such audits, whether with
respect to the BI Austria or the BI Pharma KG facility, within
[ * ] business days of InterMune's
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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notice thereof, and without delay remedy any such agreed upon
items of non-compliance with cGMP.
5.7.2. If BI Austria can not remedy such non-compliance, whether with
respect to the BI Austria or the BI Pharma KG facility, within
[ * ] business days of notice thereof BI Austria's response
shall include a written plan and timetable including
reasonable timelines. Considering the fact that BI Austria is
dependent on certain third parties to supply services to it,
BI Austria shall use best efforts to assign such timelines to
these third parties accordingly in order to meet all timelines
for such remedy. Such plan and timetable shall be subject to
InterMune's approval, which shall not unreasonably be
withheld. In the event that BI Austria does not respond with a
plan and timetable as described above within such [ * ] day
period, or InterMune does not approve such proposed plan and
timetable for good reason, the issue shall be forwarded to the
STEERING COMMITTEE for resolution. In the event InterMune
approves such plan and timetable, but BI Austria fails to
remedy such non-compliance in accordance with such plan and
timetable, then InterMune shall have the right to terminate
this Agreement pursuant to Section 13.2.1.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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5.8. MANUFACTURING FACILITIES
BI Austria represents and warrants that it and BI Pharma KG shall
obtain all relevant APPROVALS required by the relevant HEALTH
AUTHORITIES for each of their respective manufacturing facilities and
that each of their respective manufacturing facilities conform, and
will during the term of this Agreement conform, to the cGMP.
5.9. COMPLIANCE WITH LAW
5.9.1. BI Austria shall comply, and shall ensure that its
subcontractor BI Pharma KG shall comply with, all local
applicable rules, laws and regulations (including without
limitation cGMP) in performing its obligations under this
Agreement. InterMune shall comply with all applicable rules,
laws and regulations in performing its obligations under this
Agreement.
5.9.2. All costs in connection with maintaining BI Austria's and BI
Pharma KG's compliance with all applicable local regulatory
requirements and cGMP in performing under this Agreement,
including but not limited to the maintenance and upgrading of
all technical facilities and infrastructure and the training
of personnel, shall be borne by BI Austria. BI Austria shall
obtain and maintain, and shall ensure that BI Pharma KG
obtains and maintains, all permits and licenses necessary to
its performance under this Agreement at their own expense. All
costs resulting out of the SERVICES carried out at BI Austria
or BI Pharma KG, respectively, related to compliance with
regulatory requirements that were not in effect as of the
Effective Date concerning equipment and systems solely
PRODUCT-related shall be at InterMune's expense.
5.10. ENVIRONMENTAL
BI Austria shall, and shall ensure that BI Pharma KG shall, properly
dispose of any and all hazardous waste materials involved with the
manufacture of BBS and PRODUCT that are generated or resulting from the
activities performed hereunder, if any, in full compliance with all
applicable local laws and regulations at BI Austria's sole liability
and expense.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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6. CO-OPERATION AND CO-ORDINATION BETWEEN THE PARTIES
6.1. PROJECT TEAM
6.1.1. The day-to-day responsibilities of the Parties with respect to
the SERVICES shall be overseen by the PROJECT TEAM, which
shall be responsible for deciding operational and scientific
issues arising out of the SERVICES and unanimously agreeing in
good faith with respect to the monitoring of the SERVICES.
6.1.2. The PROJECT TEAM shall consist of a team consisting of equal
numbers of people, if feasible, each appointed by InterMune
and BI Austria and notified to the other, which appointees may
be changed from time to time by the appointing Party on
written notice to the other Party. Each member of the PROJECT
TEAM shall be a person of appropriate skill and experience.
Either Party may change its own designated PROJECT TEAM
members provided, however that the total number of members of
the PROJECT TEAM may not be changed if feasible, nor the
number of members representing InterMune decreased, without
the Parties' prior written agreement. InterMune's and BI
Austria's respective members of the PROJECT TEAM as of the
Effective Date are listed in EXHIBIT 8.
6.1.3. During the term of this Agreement, the PROJECT TEAM shall meet
regularly to communicate updates and provide a forum for
decision-making and rapid resolution of issues arising under
this Agreement. Meetings of the PROJECT TEAM may be conducted
by telephone conference, videoconference or face-to-face
meetings as agreed by the PROJECT TEAM, provided that the
PROJECT TEAM shall meet at least once a year in a face-to-face
meeting at a mutually agreed location.
6.1.4. Decisions of the PROJECT TEAM shall be reflected in the
approved minutes. Meeting minutes shall be prepared jointly by
the PROJECT MANAGERS to record all issues discussed and
decisions. Minutes that have not been objected to in writing
by a Party within six (6) business days of receipt thereof
shall be deemed approved by such Party and followed by
issuance of two (2) copies of the minutes duly executed by the
Parties' PROJECT MANAGER.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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6.1.5. In the event that the PROJECT TEAM is unable to reach
agreement on any issue and is unable to make decisions arising
out of operational and scientific issues within ten (10)
business days, each Party may call in an expert of its own
choice to render advice to the PROJECT TEAM. Based on the
advice of such expert(s) and the team members' know-how, the
PROJECT TEAM will try to resolve such issue. In the event that
the PROJECT TEAM fails to reach agreement on an issue within
thirty (30) business days of first undertaking resolution of
such issue, such issue shall then be referred to the STEERING
COMMITTEE for immediate resolution.
6.2. STEERING COMMITTEE
6.2.1. The Parties shall create a STEERING COMMITTEE consisting of
the PROJECT MANAGER of each Party and authorized
representatives who shall be appointed by InterMune and by BI
Austria in equal numbers, if feasible, and notified to the
other Party. The STEERING COMMITTEE shall be responsible for
unanimously agreeing in good faith all issues on which the
PROJECT TEAM has been unable to reach agreement and, where
possible, make decisions arising out of such issues as well as
carry out the specific functions, including but not limited to
decisions with an impact on costs and timelines of the
SERVICES to be carried out under this Agreement. Each Party
may change its own designated STEERING COMMITTEE members by
providing written notice thereof to the other Party; provided,
however that the total number of members of the STEERING
COMMITTEE may not be changed, if feasible, nor the number of
members representing InterMune decreased, without the Parties'
prior written agreement. The members of the STEERING COMMITTEE
are listed in EXHIBIT 13.
6.2.2. The STEERING COMMITTEE shall attempt in good faith to
expeditiously and fairly resolve all issues before it. In the
event that the STEERING COMMITTEE is unable to resolve any
issue before it within fifteen (15) business days from the
date that such issue is referred to it, such issue shall be
referred to the Chief Executive Officer of InterMune and the
Chief Executive Officer of BI Austria for prompt, good faith
resolution. If such individuals do not reach agreement on such
issue within fifteen (15) days of such referral, then each
Party shall be free to pursue all available legal and/or
equitable remedies.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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6.3. LIMITATION OF POWERS
The powers of the PROJECT TEAM and the STEERING COMMITTEE are limited
to those expressly set forth in this Agreement. Without limiting the
generality of the foregoing, neither the PROJECT TEAM nor the STEERING
COMMITTEE shall have the right to amend this Agreement. The actions of
the PROJECT TEAM and/or the STEERING COMMITTEE shall not substitute for
either Party's ability to exercise any right, nor excuse the
performance of any obligation, set forth herein.
7. INTELLECTUAL PROPERTY AND LICENSES
7.1. The ownership of INTERMUNE'S TECHNOLOGY shall remain with InterMune
and shall not vest in BI Austria.
7.2. The ownership of BI AUSTRIA'S TECHNOLOGY shall remain with BI Austria
and shall not vest in InterMune.
7.3. BI Austria shall retain ownership of BI AUSTRIA'S IMPROVEMENTS. BI
Austria hereby grants to InterMune a non-exclusive, perpetual,
sublicenseable, royalty-free license under BI AUSTRIA'S IMPROVEMENTS to
develop, use, make, have made, import, offer for sale and sell products
containing INTERFERON GAMMA 1b in the TERRITORY, whereby InterMune
shall assume the costs to be paid by BI Austria for awards to inventors
of BI AUSTRIA'S IMPROVEMENTS, as such awards are set forth in written
agreements between BI Austria and such inventor or in an applicable
industry labor contract.
7.4. The Parties shall each have an undivided one-half ownership interest in
any INFORMATION jointly conceived of or reduced to practice by the
Parties pursuant to this Agreement ("JOINT INFORMATION"). InterMune
shall [ * ] of any JOINT INFORMATION that comprises (a) any regulatory
filing (or documentation and raw data relating thereto) relating to
PRODUCT manufactured hereunder, or (b) any manufacturing documentation
(including without limitation batch records) relating to PRODUCT
manufactured hereunder ("PRODUCT INFORMATION"). Upon request by
InterMune, without additional consideration, BI Austria agrees to
promptly execute documents, testify and take other acts at InterMune's
expense as
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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InterMune may deem necessary or desirable to procure, maintain,
perfect, and enforce the full benefits, enjoyment, rights, title and
interest of the PRODUCT INFORMATION, on a worldwide basis. In the event
InterMune is unable for any reason, after reasonable effort, to secure
BI Austria's signature on any document needed in connection with the
actions specified in this Section 7.4, BI Austria hereby irrevocably
designates and appoints InterMune and its duly authorized officers and
agents as its agent and attorney in fact, which appointment is coupled
with an interest, to act for and in its behalf to execute, verify and
file any such documents and to do all other lawfully permitted acts to
further the purposes of this Section 7.4 with the same legal force and
effect as if executed by BI Austria.
7.5. InterMune hereby grants to BI Austria (with the right to sublicense
solely to BI Pharma KG) a non-exclusive, nontransferable license to use
INTERMUNE'S TECHNOLOGY solely for the purpose of (a) comparison of
PRODUCT documentation and comparison of BBS and PRODUCT and (b)
manufacturing PRODUCT for InterMune, as provided in this Agreement. The
license granted under this Section shall automatically terminate upon
the expiration or termination of this Agreement.
7.6. NEW INDICATIONS
7.6.1. In the event that InterMune receives approval in the TERRITORY
to commercially sell PRODUCT for indications other than
Chronic Granulomatous Disease, and provided that InterMune has
the right to grant a license to BII in the BI TERRITORY to
make, use and sell PRODUCT for such additional indications (a
"NEW INDICATIONS LICENSE"), InterMune shall provide BII
written notice thereof.
7.6.2. BII shall notify InterMune in writing within thirty (30) days
of InterMune's notice (the "NOTIFICATION PERIOD") whether BII
desires to obtain a NEW INDICATIONS LICENSE. If InterMune does
not receive written notice from BII during the NOTIFICATION
PERIOD that BII desires to obtain a NEW INDICATIONS LICENSE,
then InterMune shall have no further obligations under this
Section 7.6. If InterMune does receive written notice from BII
that BII desires to obtain a NEW INDICATIONS LICENSE, then BII
and InterMune shall engage in good faith negotiations for
sixty (60) business days thereafter regarding the reasonable
commercial terms upon which InterMune would be willing to
grant such a license. If at the end of such sixty (60)
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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business day period, BII and InterMune have not entered into a
written agreement under which InterMune grants a NEW
INDICATIONS LICENSE to BII, then InterMune shall have no
further obligation under this Section 7.6.
8. COMPLAINTS; ADVERSE EVENTS; RECALLS
8.1. InterMune shall inform BI Austria of any complaints, adverse
reaction reports, safety issues or toxicity issues relating to any
PRODUCT of which it becomes aware, regardless of the origin of such
information, within the time frame required by cGMP but in no event
later than two (2) days from the initial complaint or report.
8.1.1. InterMune shall retain and manage complaints in accordance
with cGMP. The Parties hereby agree to cooperate with one
another and with any HEALTH AUTHORITY in the evaluation and
investigation of any complaint, claim or adverse reaction
report related to the manufacture of such PRODUCT with the
intention of complying with cGMP.
8.1.2. If any such event occurs, BI Austria shall retain any unused
supplies of such PRODUCT and its associated components, and
all associated batch and other production records in such
manner as InterMune may reasonably direct, and at InterMune's
expense, except to the extent such event is caused by BI
Austria's wrongful act or omission. BI Austria agrees to
respond to InterMune in respect to such complaint
investigations involving BI Austria's manufacturing of a
PRODUCT or SERVICES rendered hereunder as soon as reasonably
possible but in any case within thirty (30) days from receipt
by BI Austria of the report of such complaint and sample (if
available), or in the case of a serious adverse event, within
ten (10) days from receipt of the report of such complaint and
sample (if available). InterMune and/or its designee shall
serve as the sole point of contact with the FDA or other
applicable HEALTH AUTHORITY concerning any complaints, adverse
reaction reports, safety issues or toxicity issues with
respect to PRODUCT.
8.2. If either Party becomes aware at any time of any defect or the
possibility of any defect associated with any PRODUCT manufactured by
BI Austria hereunder, such Party will notify the other Party
immediately and confirm the notification as soon as possible in
writing.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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8.3. InterMune shall notify BI Austria promptly if any PRODUCT manufactured
by BI Austria hereunder is the subject of a recall, market withdrawal
or correction, and InterMune and/or its designee shall have the sole
responsibility for the handling and disposition of such recall, market
withdrawal or correction. In the event that a recall is required in
connection with BI Austria's breach of any of its warranties set forth
in Section 10.2 hereof, BI Austria shall reimburse InterMune for the
purchase price of such PRODUCT and all other reasonable costs and
expenses associated with such PRODUCT recall, market withdrawal or
correction, but only to the extent that the foregoing costs and
expenses are attributable to BI Austria's breach of its warranties
hereunder. In all other events of a recall, all costs and expenses
incurred in connection with such PRODUCT recall shall be borne by
InterMune. InterMune and/or its designee shall serve as the sole point
of contact with the FDA or other applicable HEALTH AUTHORITY concerning
any recall, market withdrawal or correction with respect to the
PRODUCT.
8.4. INSURANCE
During the term of this Agreement, the Parties shall maintain product
liability insurance in such amounts and with such scope of coverage as
are adequate to cover the Parties' obligations under this Agreement
and as appropriate for companies of like size, taking into account the
scope of activities contemplated herein. Notwithstanding the foregoing
the Parties shall maintain minimum limits of liability of [ * ] US$
per occurrence and in the aggregate annually. The Parties shall
provide to each other within ten (10) business days of execution of
this Agreement and thereafter, once a year upon the other Party's
request, a certificate of insurance evidencing the respective Party's
product liability insurance. In addition to the foregoing coverage,
the Parties shall maintain Comprehensive General Liability Insurance
for limits of not less than [ * ] US$ combined single limit for bodily
injury and broad form property damage.
9. REPRESENTATIONS AND WARRANTIES
9.1. Each Party hereby represents and warrants to the other Party that: (a)
the person executing this Agreement is authorized to execute this
Agreement; (b) this Agreement is legal and valid and the obligations
binding upon such Party are enforceable by their terms; and (c) the
execution, delivery and performance of this Agreement does not
conflict with any agreement, instrument
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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or understanding, oral or written, to which such Party may be bound,
nor violate any law or regulation of any court, governmental body or
administrative or other agency having jurisdiction over it.
9.2. BI Austria represents and warrants that:
9.2.1. All BBS manufactured hereunder shall conform to BULK
SPECIFICATIONS;
9.2.2. All PRODUCT manufactured and supplied hereunder shall - at the
date of shipment - conform to the PRODUCT SPECIFICATIONS;
9.2.3. All BBS and PRODUCT manufactured and supplied hereunder shall
be manufactured in accordance with the MANUFACTURING PROCESS;
9.2.4. All BBS and PRODUCT manufactured hereunder shall be
manufactured, handled, stored, labeled, packaged and
transported (from BI Austria to BI Pharma KG) in accordance
with the cGMP requirements, the QUALITY ASSURANCE REQUIREMENTS
as listed in EXHIBIT 10 and all applicable laws, regulations
and ordinances of the jurisdiction in which such manufacture
occurs.
9.2.5. No PRODUCT manufactured and supplied to InterMune hereunder
shall be (i) adulterated or misbranded by BI Austria within
the meaning of the FD&C Act, or (ii) an article that may not
be introduced into interstate commerce under the provisions of
Sections 404 or 505 of the FD&C Act; and
9.2.6. BI Austria shall not use and shall secure that BI Pharma KG
shall not use in any capacity the services of any persons
debarred under 21 U.S.C. sections 335 (a) and 335 (b) in
connection with the manufacture of the PRODUCT under this
Agreement.
9.3. BI Austria represents and warrants that it has in place, and that BI
Pharma KG has in place, a program designed to ensure that each will be
Year 2000 Compliant (as defined below) or that its failure to be Year
2000 Compliant will not materially affect its performance under this
Agreement. For purposes of this Section, "Year 2000 Compliant" means
that the computer systems used in connection with the performance of
work under this Agreement shall operate and function without (i) any
failure of such computer systems properly to record, store, process,
calculate or present calendar dates falling after (and if applicable,
spans of time including)
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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January 1, 2000 as a result of the occurrence, or use of data
consisting of, such dates; (ii) any failure of such computer systems to
calculate any information dependent on or relating to dates after
January 1, 2000 in the same manner, and with the same functionality,
data integrity and performance, as such computer system records,
stores, processes, calculates and presents calendar dates on or before
December 31, 1999, or information dependent on or relating to such
dates; or (iii) any loss of functionality or performance with respect
to the introduction of records or processing of data containing dates
falling after January 1, 2000. Upon Effective Date of this Agreement BI
Austria and BI Pharma KG have not observed any Year 2000 incompliance.
9.4. Except as expressly provided for herein, BI Austria makes no further
warranties of the merchantability or fitness of the PRODUCT or any
warranties of any other nature, express or implied.
10. INDEMNIFICATION
10.1. Subject to Section 10.3., BI Austria shall indemnify, defend and hold
harmless InterMune and its officers, directors, employees and agents
from and against all third party costs, claims, (including death and
bodily injury) suits, expenses (including reasonable attorneys' fees),
liabilities and damages (collectively, "LIABILITIES") arising out of
or resulting from any willful or negligent act or omission by BI
Austria or BI Pharma KG relating to the subject matter of this
Agreement, or any defect in the manufacture or any failure to deliver
PRODUCT in accordance with BI Austria's warranties (except to the
extent such LIABILITIES arose or resulted from any negligent act or
omission by InterMune).
10.2. Subject to Section 10.3, InterMune shall indemnify, defend and hold
harmless BI Austria and its officers, directors, employees and agents
from and against all LIABILITIES arising out of or resulting from any
willful or negligent act or omission by InterMune relating to the
subject matter of this Agreement, or the use by or administration to
any person of a PRODUCT that arises out of this Agreement (except to
the extent such LIABILITIES arose or resulted from any negligent act
or omission by BI Austria or BI Pharma KG or any defect in the
manufacture of PRODUCT or any failure to deliver PRODUCT in accordance
with BI Austria's warranties).
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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10.3. A Party and its directors, officers, employees and agents which intends
to claim indemnification under this Article 10 (each, an "INDEMNITEE")
shall promptly notify the other Party (the "INDEMNITOR") in writing of
any action, claim or other matter in respect of which the INDEMNITEE
intend to claim such indemnification; PROVIDED, HOWEVER, that the
failure to provide such notice within a reasonable period of time shall
not relieve the INDEMNITOR of any of its obligations hereunder except
to the extent that the INDEMNITOR is prejudiced by such failure. The
INDEMNITEE shall permit the INDEMNITOR at its discretion to settle any
such action, claim or other matter, and the INDEMNITEE agrees to the
complete control of such defense or settlement by the INDEMNITOR.
Notwithstanding the foregoing, the INDEMNITOR shall not enter into any
settlement that would adversely affect the INDEMNITEE's rights
hereunder, or impose any obligations on the INDEMNITEE in addition to
those set forth herein in order for it to exercise such rights, without
INDEMNITEE's prior written consent, which shall not be unreasonably
withheld or delayed. No such action, claim or other matter shall be
settled without the prior written consent of the INDEMNITOR, which
shall not be unreasonably withheld or delayed. The INDEMNITOR shall not
be responsible for any attorneys' fees or other costs incurred other
than as provided herein. The INDEMNITEE shall cooperate fully with the
INDEMNITOR and its legal representatives in the investigation and
defense of any action, claim or other matter covered by the
indemnification obligations of this Article 10. The INDEMNITEE shall
have the right, but not the obligation, to be represented in such
defense by counsel of its own selection and at its own expense.
11. LIMITATIONS ON LIABILITY
11.1. Except with respect to each Party's indemnification obligations under
Article 10, in no event shall either Party be liable to the other
Party for any consequential, incidental, special or indirect damages
arising in connection with this Agreement.
11.2. Except with respect to [ * ] under this Agreement shall [ * ] under
this Agreement.
12. CONFIDENTIALITY
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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12.1. Each Party shall treat confidentially all CONFIDENTIAL INFORMATION of
the other Party, and shall not use or disclose such CONFIDENTIAL
INFORMATION other than it is expressly permitted under this Agreement.
Each Party will take steps to protect the other Party's CONFIDENTIAL
INFORMATION that are at least as stringent as the steps such Party
uses to protect its own CONFIDENTIAL INFORMATION, but in no event
shall be less than reasonable. Each Party may disclose the other
Party's CONFIDENTIAL INFORMATION to employees, contractors and agents
who are bound by written obligations of confidentiality and non-use
consistent with those set forth in this Agreement.
12.2. Each Party may disclose Confidential Information of the other Party
hereunder to the extent that such disclosure is reasonably necessary
for prosecuting or defending litigation, complying with applicable
government regulations, conducting preclinical or clinical trials or
obtaining marketing approval for the PRODUCT, provided that if a Party
is required by law or regulation to make any such disclosure of the
other Party's CONFIDENTIAL INFORMATION it will, except where
impracticable for necessary disclosures, for example in the event of
medical emergency, give reasonable advance notice to the other Party of
such disclosure requirement and will use its best efforts assist such
other Party to secure a protective order or confidential treatment of
such CONFIDENTIAL INFORMATION required to be disclosed.
12.3. Neither Party shall disclose CONFIDENTIAL INFORMATION of the other
Party in any patent filings without the prior written consent of such
other Party.
12.4. The Parties agree that, except as may otherwise be required by
applicable laws, regulations, rules, or orders, including without
limitation the rules and regulations promulgated by the US Securities
and Exchange Commission, and except as may be authorized in Section
12.2, no material information concerning this Agreement and the
transactions contemplated herein shall be made public by either Party
without the prior written consent of the other. The Parties agree that
the public announcement of the execution of this Agreement shall be by
one or more press releases mutually agreed to by the Parties. A failure
of a Party to return a draft of a press release with its proposed
amendments or modifications to such press release to the other Party
within five (5) business days of such Party's receipt of such press
release shall be deemed as such Party's approval of such press release
as received by such Party. Each Party agrees that it shall cooperate
fully and in a timely manner with the other with respect to all
disclosures to the Securities and Exchange Commission and any other
governmental and regulatory agencies,
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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including requests for confidential treatment of CONFIDENTIAL
INFORMATION of either Party included in any such disclosure.
12.5. This confidentiality obligations of this Article 12 shall survive the
termination or expiration of this Agreement for a period of five (5)
years.
13. DURATION AND TERMINATION
13.1. DURATION
This Agreement shall be effective as of the Effective Date and shall
continue in force until December 31, 2006. This Agreement shall
automatically renew for successive [ * ] periods, provided, however,
that either Party may elect not to renew this Agreement by providing
the other Party written notice of such election at least [ * ] prior to
the date of expiration of the then-current term.
13.2. EARLY TERMINATION
13.2.1. In the event that a Party materially breaches its obligations
under this Agreement (including without limitation a MATERIAL
SUPPLY BREACH), the non-breaching Party may terminate this
Agreement upon thirty (30) days prior written notice to the
breaching Party, unless the breaching Party cures such breach
to the non-breaching Party's reasonable satisfaction during
such thirty day period. Notwithstanding the preceding
sentence, in the event that a Party materially breaches its
obligations under this Agreement more than two (2) times in
any consecutive twenty-four (24) month period, the
non-breaching Party may terminate this Agreement immediately
without providing the breaching Party an opportunity to cure
such breach, by giving the breaching Party written notice
thereof.
13.2.2. Each Party may terminate this Agreement by notice in writing
to the other Party, for cause, if such other Party is
adjudicated to be insolvent or files a petition in bankruptcy.
13.2.3. InterMune may immediately terminate this Agreement by notice
in writing if InterMune should be prevented by the HEALTH
AUTHORITIES from using PRODUCT in clinical
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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trials or from distributing PRODUCT on the market. In such
event, InterMune shall be liable to BI Austria for the
reasonable, non-cancelable costs which BI Austria has already
incurred in fulfilling any firm order from InterMune (e.g.
costs in connection with manufacture of intermediate products
like inactivated cell paste, BBS and PRODUCT) that are not
otherwise recoverable by BI Austria through the manufacture of
INTERFERON GAMMA 1b for its own use; provided that InterMune
shall have no liability to BI Austria under this Section
13.2.3 in the event that such HEALTH AUTHORITY action is
solely due to any breach of BI Austria's warranties under this
Agreement or any negligence or willful misconduct by BI
Austria or BI Pharma KG.
13.2.4. Either Party may terminate this Agreement upon twelve (12)
months written notice in the event that the other Party
assigns this Agreement pursuant to Section 14.3.
13.2.5. All payments in connection with early termination shall be
due within thirty (30) days after receipt by BI Austria of
the notice of early termination from InterMune and receipt
by InterMune of the respective invoice from BI Austria.
13.3. EFFECT OF TERMINATION
13.3.1. In the event of any termination of this Agreement (other than
for BI Austria's material breach):
13.3.1.1. InterMune agrees to purchase, and BI Austria agrees
to sell, any PRODUCT manufactured by BI Austria and
held by BI Austria against the requirements of a
binding purchase order on the effective date of
termination at the applicable purchase price, subject
to InterMune's acceptance of such PRODUCT pursuant to
Section 3.5.
13.3.1.2. At the request of InterMune, BI Austria shall
fulfill any outstanding binding purchase orders for
PRODUCT using, at BI Austria's option, materials on
hand or on order by BI Austria for such purchase
order, in accordance with the terms of this
Agreement. In such event, such PRODUCT shall be
purchased by InterMune at the applicable purchase
price, subject to InterMune's acceptance of such
PRODUCT pursuant to Section 3.5. Alternatively,
InterMune agrees to purchase any raw materials and
components which have been ordered by BI
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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Austria pursuant to a non-cancelable purchase order
and unutilized for such purchase order, at cost only
if they can not be used by BI Austria otherwise.
13.3.2. In the event of any termination or expiration of this
Agreement, at the request of InterMune, BI Austria shall
either (i) destroy all material, including but not limited to
samples and all documentation received from InterMune under
this Agreement, or (ii) deliver the same to InterMune or a
party nominated by InterMune, at InterMune's cost (except in
the case of termination by InterMune for BI Austria's material
breach, in which case such destruction or delivery shall be at
BI Austria's expense).
13.3.3. BI Austria shall promptly return all of InterMune's
CONFIDENTIAL INFORMATION to InterMune, except for a single
copy and/or sample of each item for documentation purposes
only. BI Austria's responsibility to keep and store all other
materials provided by InterMune in the course of this
Agreement shall terminate six (6) months after expiration or
termination of this Agreement (except as otherwise provided in
Section 5.2).
13.3.4. InterMune shall promptly return all of BI Austria's
CONFIDENTIAL INFORMATION to BI Austria, except for a single
copy and/or sample for documentation purposes only.
13.3.5. The following provisions shall survive termination of this
Agreement: Sections 3.8.1, 5.2.3, 7.1, 7.2, 7.3, 7.4, 7.5, 8,
10, 11, 12, 13.2.3, 13.2.5, 13.3 and 14. Termination of this
Agreement shall not relieve either Party of any liability
which accrued hereunder prior to the effective date of such
termination, nor preclude either Party from pursuing all
rights and remedies it may have hereunder or at law or in
equity with respect to any breach of this Agreement, nor
prejudice either Party's right to obtain performance of any
obligation.
14. MISCELLANEOUS
14.1. PERFORMANCE BY AFFILIATES
`
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
39 of 66
The Parties recognize that each Party may perform some or all of its
obligations under this Agreement through one or more of its AFFILIATES,
provided, however, that each Party shall remain responsible for such
performance by its AFFILIATES and shall cause its AFFILIATES to comply
with the provisions of this Agreement in connection with such
performance. Each Party hereby expressly waives any requirement that
the other Party exhaust any right, power or remedy, or proceed against
an AFFILIATE, for any obligation or performance hereunder prior to
proceeding directly against such Party.
14.2. FORCE MAJEURE
Neither Party shall be liable for any failure or delay in performance
or non-performance caused by circumstances beyond the reasonable
control of such Party, including but not limited to acts of God,
explosion, fire, flood, labor strike or labor disturbances, sabotage,
order or decree of any court or action of any governmental authority
(except where such order, decree or action is a direct result of BI
Austria's breach of its obligations hereunder), or other causes,
whether similar or dissimilar to those specified which cannot
reasonably be controlled by the Party who failed to perform (each such
event, a "FORCE MAJEURE EVENT"). A Party affected by a FORCE MAJEURE
EVENT shall give notice of such to the other Party as soon as is
reasonably possible, and shall resume performance hereunder as soon as
is reasonably possible. Each Party shall have the right to terminate
this Agreement in the event that a FORCE MAJEURE EVENT continues for
more than thirty (30) business days upon written notice thereof.
14.3. ASSIGNMENT
14.3.1. Except as expressly provided for herein neither this Agreement
nor any rights or obligations hereunder may be assigned by
either Party except to an AFFILIATE of either one of the
Parties without the prior written consent of the other Party
which shall not be unreasonably withheld or delayed. Any
subsequent assignee or transferee shall be bound by the terms
of this Agreement. Any assignment of this Agreement that is
not in conformance with this Section 14.3 shall be null, void
and of no legal effect.
14.3.2. Notwithstanding the foregoing, InterMune shall have the right
to assign this Agreement in case of a merger, acquisition or
sale of substantially all of its assets that relate to this
Agreement after due written notification of BI Austria.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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14.3.3. In the event that either Party assigns this Agreement as
permitted under this Section, the other Party shall have the
right to terminate this Agreement upon twelve (12) months
written notice.
14.4. NOTICES
Any notice required or permitted to be given hereunder by either Party
shall be in writing and shall be (i) delivered personally, (ii) sent by
registered mail, return receipt requested, postage prepaid or (iii)
delivered by facsimile and confirmed by certified or registered mail to
the addresses or facsimile numbers set forth below:
If to InterMune: InterMune Pharmaceuticals, Inc.
0000 Xxxx Xxxxxxxx Xxxx
Xxxx Xxxx, XX 00000 XXX
Facsimile: +1 - 650 - 858 - 2937
Attention: Xxxxx Van Vlasselaer
If to BI Austria: Boehringer Ingelheim Austria GmbH
Xx. Xxxxxxxxxx-Xxxxx 0 - 00
X-0000 Xxxxxx, Xxxxxxxx of Austria
Facsimile: +43 - 1 - 801 05 - 2440
Attention: Xxxxxx Xxxxxxxxx
Business Support Biotech
with a copy to: Boehringer Ingelheim GmbH
Xxxxxx Xxxxxxx 000
X-00 216 Ingelheim am Rhein
Facsimile: +49 - 61 32 77 - 98 287
Attention: Xxxx X. Xxxxxx
Head of Industrial Biopharmaceuticals
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
41 of 66
14.5. DISPUTE RESOLUTION; GOVERNING LAW
14.5.1. In the event of any controversy or claim arising out of,
relating to or in connection with any provision of this
Agreement, or the rights or obligations of the Parties
hereunder, the Parties first shall try to settle their
differences amicably between themselves by referring the
disputed matter to the Chief Executive Officer of InterMune
and the Chief Executive Officer of BI Austria for discussion
and resolution. Either Party may initiate such informal
dispute resolution by sending written notice of the dispute to
the other Party, and within ten (10) days of such notice the
Chief Executive Officer of InterMune and the Chief Executive
Officer of BI Austria shall meet for attempted resolution by
good faith negotiations. If such personnel are unable to
resolve such dispute within thirty (30) days of initiating
such negotiations, each Party may thereafter pursue any and
all rights and remedies it may have at law or equity. If
mutually agreeable, the Parties may explore alternative forms
of dispute resolution, such as mediation.
14.5.2. This Agreement shall be governed by and construed in
accordance with the laws of the place of domicile of the
defendant party.
14.5.3. The Parties expressly exclude the application of the United
Nations Convention on Contracts for the International Sale of
Goods to this Agreement.
14.6. INDEPENDENT CONTRACTOR
Each of the Parties hereto is an independent contractor and nothing
herein contained shall be deemed to constitute the relationship of
partners, joint venture, nor of principal and agent between the Parties
hereto. Neither Party shall have the authority to bind the other Party.
14.7. WAIVER
Any delay in enforcing a Party's rights under this Agreement or any
waiver as to a particular default or other matter shall not constitute
a waiver of such Party's rights to the future enforcement of its rights
under this Agreement, excepting only as to an express written and
signed waiver as to a particular matter for a particular period of
time.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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14.8. SEVERABILITY
If any of the provisions of this Agreement or parts thereof should be
or become invalid, the remaining provisions will not be affected. The
Parties shall undertake to replace the invalid provision or parts
thereof by a new provision which will approximate as closely as
possible the intent of the Parties.
14.9. ENTIRE AGREEMENT
This Agreement and the Exhibits set forth the entire agreement between
the Parties, and supersede all previous agreements, negotiation and
understanding, written or oral, regarding the subject matter hereof.
This Agreement may be modified or amended only by an instrument in
writing duly executed on behalf of the Parties.
14.10. HEADINGS
The section headings appearing herein are included solely for
convenience of reference and are not intended to affect the
interpretation of any provision of this Agreement.
14.11. AMBIGUITIES
Ambiguities, if any, in this Agreement shall not be strictly construed
against either Party, regardless of which Party is deemed to have
drafted the provision at issue.
14.12. COUNTERPARTS
The Agreement may be executed in two or more counterparts, each of
which shall be an original and all of which shall constitute the same
document.
14.13. ENGLISH LANGUAGE
The English language will govern any interpretation of or dispute in
connection with this Agreement.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
by their duly authorized representatives as of the Effective Date.
Vienna, Austria Palo Alto, California
BOEHRINGER INGELHEIM INTERMUNE. PHARMACEUTICALS, INC
AUSTRIA GMBH
BY: /s/ Xxxxxxxx Xxxxxxx BY: /s/ W. Xxxxx Xxxxxxxx
----------------------------------- -----------------------------------
NAME: Mag. DI Xxxxxxxx Xxxxxxx NAME: Xxxxx Xxxxxxxx, Ph.D.
TITLE: Head of Production and Engineering TITLE: Chief Executive Officer
DATE: 27 January 2000 DATE: February 3, 2000
BY: /s/ Xxxx X. Xxxxxx BY: /s/ Xxxxx Van Vlasselaer
----------------------------------- -----------------------------------
NAME: Prof. Xx. Xxxx X. Xxxxxx NAME: Xxxxx Van Vlasselaer, Ph.D.
TITLE: Head of Industrial Biopharmaceuticals TITLE: Sen. Vice President Techn. Operations
DATE: 27 January 2000 DATE: February 3, 2000
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
44 of 66
TABLE OF EXHIBITS
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT
Exhibit 1 BI Territory
Exhibit 2 BBS SPECIFICATION
Exhibit 3 COA
Exhibit 4 COC
Exhibit 5 DNA sequence of INTERFERON GAMMA 1 b
Exhibit 6 MANUFACTURING PROCESS
Exhibit 7 PRODUCT
Exhibit 8 PROJECT MANAGER and PROJECT TEAM
Exhibit 9 PRODUCT SPECIFICATION
Exhibit 10 QUALITY ASSURANCE REQUIREMENTS
Exhibit 11 SERVICES
Exhibit 12 Timeline
Exhibit 13 STEERING COMMITTEE
Exhibit 14 Documentation to be supplied from Genentech
Exhibit 15 Protocol comparing BBS and PRODUCT
Exhibit 16 Forecast model
Exhibit 17 Prices for PRODUCT and placebo
Exhibit 18 Payment Schedule
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
45 of 66
EXHIBIT 1
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
BI TERRITORY:
World-wide except USA, [ * ], Japan
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
46 of 66
EXHIBIT 2
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
BBS SPECIFICATIONS:
[ * ]
Note: Differences between the specifications are marked in blue
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
47 of 66
EXHIBIT 3
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
CERTIFICATE OF ANALYSIS (COA):
Each COA shall certify with respect to each shipment and lot (identified by
batch or lot number) that the BBS and/or PRODUCT was manufactured in accordance
with the Specifications and the Master Batch Record and in conformance with
cGMPs.
Attached is a specimen.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
48 of 66
BOEHRINGER
INGELHEIM
Boehringer Ingelheim Austria GmbH
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
49 of 66
EXHIBIT 4
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
CERTIFICATE OF COMPLIANCE (COC):
Xxxxxxx Xxxx
PT
PTS
Company
Attention to:
Address Date 2000
Address
Boehringer Ingelheim
Austria GmbH
Xx. Xxxxxxxxxx-Xxxxx 0-00
X-0000 Xxxxxx
Phone ++ 43-1-80 000-0000
Telefax ++43-1-80 105-2487
E-Mail xxxxxxx.gogg@
Xxx.xxxxxxxxxx-Xxxxxxxxx.xxx
Compliance Certificate Product Name
Boehringer Ingelheim Austria (BIA) has manufactured
Product Name
Lot No.: B XXXXXX
In a GMP facility and in accordance with BIA Standard Operating Procedures.
Appropriate cGMP Guidelines were followed and no outstanding non-conformances
or deviations remain un-resolved.
X. Xxxxxxxxx X. Xxxxxx X. Xxxx
Quality Control Production Quality Assurance
BOEHRINGER INGELHEIM
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
50 of 66
AUSTRIA GmbH
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
51 of 66
EXHIBIT 5
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
DNA SEQUENCE OF INTERFERON GAMMA 1b
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
52 of 66
EXHIBIT 6
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
MANUFACTURING PROCESS
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
53 of 66
EXHIBIT 7
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
PRODUCT:
[ * ]
LABELING AND PACKAGING:
- for CLINICAL TRIAL SUPPLY: [ * ]
[ * ]
- for MARKET SUPPLY: [ * ]
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
54 of 66
EXHIBIT 8
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
PROJECT MANAGER AND PROJECT TEAM:
BI AUSTRIA AND BI PHARMA KG
Project Manager: Xx. Xxxxxx Xxxxxxxxx, Business Support Biotech
Project Team: Anton Vollbauer, Fermentation
Xxxxx Xxxxxx, Purification
Xx. Xxxxxxx Xxxxxxxxx, QC
Xxxxxxx Xxxx, QA
Xx. Xxxxxx-Xxxx Xxxxxxx, Head of Lyophilisation
INTERMUNE
Project Manager: Xxxxx Van Vlasselaer, Ph.D., Senior VP Technical Operations
Project Team: Xxxxx Xxxxx, Regulatory
(position to be filled), QA/QC
(position to be filled, Xxx Xxxxxx), Manufacturing
(position to be filled), Administrative help
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
55 of 66
EXHIBIT 9
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
PRODUCT SPECIFICATIONS:
[ * ]
EXHIBIT 9 CONTINUING
[ * ]
Note: Differences between the specifications are marked in blue
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
56 of 66
EXHIBIT 10
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
INTERMUNE'S QUALITY ASSURANCE REQUIREMENTS FOR ACTIMMUNE:
- FOR THE FIRST THREE CONFORMANCE LOTS:
1. Client copy of manufacturing batch production record
2. Client copy of filling batch production record
3. Client copy of packaging batch production record
4. Client copies of all deviations and their investigations
5. Client copy of certificate of analysis (COA) with the pre-set product
specifications and the lot test results
6. Client copy of analytical test data (one batch only)
7. Certificate of Compliance (COC)
- AFTER THE FIRST THREE CONFORMANCE LOTS:
All documents listed above (point 1 - 7) are available for InterMune's
inspection upon prior notice or during audits of both BI production sites. The
procedure for manufacturer qualification and the scope of batch related
documentation to be finally submitted to InterMune will be discussed and defined
between the Parties during the course of this Agreement.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
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EXHIBIT 11
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
SERVICE FOR US REGISTRATION OF rIFN-GAMMA:
1. CARRIED OUT BY BI AUSTRIA
[ * ]
EXHIBIT 11 continuing
2. CARRIED OUT BY BI PHARMA KG
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
58 of 66
EXHIBIT 12
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
TIMELINE / PROJECT PLAN:
See attachment
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
59 of 66
EXHIBIT 13
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
STEERING COMMITTEE
BI Austria: Xxxx. Xxxx Xxxxxx (Head Industrial Biopharmaceuticals,
BI Headquarters)
Dr. Xxxx Konopitzky (Head of Production and Engineering)
DI. Xxxx Xxxxxx (Head of Biotech Production)
Xx. Xxxxxx Xxxxxxxxx (Project Manager / Reporter)
InterMune: Xx. Xxxxx Xxxxxxxx (President and CEO)
(position to be filled)
(position to be filled)
Dr. Xxxxx Van Vlasselaer (Project Manager / Reporter)
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
60 of 66
EXHIBIT 14
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
DOCUMENTATION, MATERIAL AND DATA:
A. DOCUMENTATION AND DATA SUPPLIED BY GENENTECH
[ * ]
Exhibit 14 continuing
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
61 of 66
EXHIBIT 15
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
PROTOCOL COMPARING BBS AND PRODUCT
Scope
This protocol is established to show equivalence of rIFN-gamma bulk biological
substance (BBS) and finished product produced by Genentech and the rIFN-gamma
BBS produced by Boehringer Ingelheim Austria, Vienna, and finished product
filled by Boehringer Ingelheim Pharma KG, Germany, Biberach.
Background and History
[ * ]
Production process and quality control
[ * ]
Stability
[ * ]
Structure of the protocol and testing scope
1. COMPARISON OF BBS PRODUCED AT GENENTECH AND BIA
[ * ]
2. COMPARISON OF FINISHED PRODUCT PRODUCED AT GENENTECH AND BI PHARMA KG
[ * ]
3. COMPARISON OF REFERENCE MATERIAL
[ * ]
REMARK:
This protocol will be up-dated in order to include the FDA recommendation given
in the meeting, Washington 7 Dec 99.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
62 of 66
EXHIBIT 16
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
FORECAST MODEL; FIRM ORDERS AND FORECAST REGULATION
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
63 of 66
EXHIBIT 17
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
Prices for PRODUCT and placebo
A) Price of PRODUCT
[ * ]
B) Price for placebo
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
64 of 66
EXHIBIT 18
TO THE DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT DATED 27 JAN
2000
Between InterMune and BI Austria
PAYMENT SCHEDULE:
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
65 of 66
