EXHIBIT 10.8
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.
CONTRACT RESEARCH AND DEVELOPMENT AGREEMENT
ON
INTERFERON-OMEGA (IFN-OMEGA)
TABLE OF CONTENTS
PAGE
1. DEFINITIONS..............................................................................................1
1.1 "Affiliate".....................................................................................1
1.2 "BioMedicines"..................................................................................1
1.3 "BI Pharma KG"..................................................................................2
1.4 "BioMedicines Confidential Information".........................................................2
1.5 "Cell Line(s)"..................................................................................2
1.6 "Certificate of Analysis".......................................................................2
1.7 "Effective Date"................................................................................2
1.8 "GMP"...........................................................................................2
1.9 "License Agreement".............................................................................2
1.10 "Master Cell Bank (MCB)"........................................................................2
1.11 "Manufacturers Working Cell Bank(s) (MWCB)".....................................................2
1.12 "Phase I".......................................................................................3
1.13 "Phase II"......................................................................................3
1.14 "Process".......................................................................................3
1.15 "Product".......................................................................................3
1.16 "Project".......................................................................................3
1.17 "Project Fee"...................................................................................3
1.18 "Project Manager"...............................................................................3
1.19 "Project Team"..................................................................................3
1.20 "Start Date"....................................................................................3
1.21 "Sublicensee"...................................................................................3
1.22 "BI Pharma KG Confidential Information".........................................................3
1.23 "Specifications"................................................................................4
2. COOPERATION BETWEEN THE PARTIES IN THE COURSE OF THE PROJECT.............................................4
2.1 Designation of Project Manager..................................................................4
2.2 Cooperation.....................................................................................4
3. BIOMEDICINES RESPONSIBILITIES............................................................................4
3.1 General.........................................................................................4
[ * ] = 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.
i
TABLE OF CONTENTS
(CONTINUED)
PAGE
3.2 Specific........................................................................................4
4. BI PHARMA KG RESPONSIBILITIES............................................................................4
4.1 Master Projectplan including Project Timeline...................................................4
4.2 Documentation...................................................................................5
4.3 Additional Work.................................................................................5
5. PROJECT TO BE CONDUCTED ON FIXED-FEE BASIS...............................................................5
6. PROJECT FEE..............................................................................................5
7. PROGRESS TO PHASE II.....................................................................................6
7.1 Start of a Possible Phase II....................................................................6
8. OWNERSHIP OF/LICENSE TO PROJECT DATA.....................................................................6
8.1 Transfer of Project Data........................................................................6
8.2 Interim Reports.................................................................................6
8.3 License for the Use of Project Data.............................................................6
9. COMMERCIAL PRODUCTION AND SUPPLY.........................................................................6
9.1 BI Pharma KG's Right and Obligation to Commercial Production and Supply.........................6
9.2 Terms and Conditions............................................................................6
9.3 BI Pharma KG's Inability to Manufacture.........................................................6
9.4 BioMedicines Forecast/Capacities/Exceeding Quantities...........................................7
9.5 Pricing.........................................................................................7
10. REPRESENTATIONS, WARRANTIES AND INDEMNIFICATION..........................................................7
10.1 BioMedicines....................................................................................7
10.2 BI Pharma KG....................................................................................8
10.3 No Additional Warranty..........................................................................8
11. LIABILITY................................................................................................9
11.1 Limitation of Liability.........................................................................9
11.2 Special Limitation of Liability.................................................................9
11.3 Maximum Amount..................................................................................9
12. CONFIDENTIALITY..........................................................................................9
12.1 BI Pharma KG....................................................................................9
[ * ] = 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.
ii
TABLE OF CONTENTS
(CONTINUED)
PAGE
12.2 BioMedicines...................................................................................10
12.3 Exceptions to Confidentiality..................................................................10
12.4 Others.........................................................................................10
13. TERM AND TERMINATION....................................................................................10
13.1 Term...........................................................................................10
13.2 Right to Terminate.............................................................................11
13.3 Termination with Immediate Effect..............................................................11
13.4 Effect of Termination..........................................................................11
14. FORCE MAJEURE...........................................................................................12
15. PUBLICITY...............................................................................................12
16. NOTICES.................................................................................................12
17. APPLICABLE LAW..........................................................................................12
18. COMPLIANCE WITH LAWS....................................................................................12
19. INDEPENDENT CONTRACTORS.................................................................................13
20. WAIVER..................................................................................................13
21. SEVERABILITY............................................................................................13
22. ENTIRETY................................................................................................13
23. ASSIGNMENT..............................................................................................13
APPENDICES.......................................................................................................14
[ * ] = 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.
iii
THIS CONTRACT RESEARCH AND DEVELOPMENT AGREEMENT ("Agreement") is made
effective as of 17 July, 1998 ("Effective Date"), by and among BIOMEDICINES,
INC. ("BioMedicines), a incorporated in the state of Delaware in the United
States of America, having its principal business offices at 000 Xxxxxx Xxxxxxx
Xxxxxxx Xx. 000, Xxxxxxx, XX 00000, and BOEHRINGER INGELHEIM PHARMA KG ("BI
Pharma KG") a German corporation having a place of business at Xxxxxxxxxxxx
Xxxxxxx 00, 00000 Xxxxxxxx an der Riss, Federal Republic of Germany.
BACKGROUND
BioMedicines has a license to certain proprietary rights in
INTERFERON-OMEGA ("IFN-OMEGA") from Boehringer Ingelheim International GmbH
("BII"), a German corporation, under a separate agreement dated 17 July, 1998
and which is referenced in toto hereby.
BI Pharma KG owns all of the appropriate and specialized cell culture,
processing, protein purification aseptic filling and lyophilisation equipment,
as well as suitable packaging and labeling facilities that are necessary and
sufficient for the production of IFN-OMEGA, and, furthermore, employs personnel
who have the requisite experience, knowledge, and expertise in production of
proteins by cell culture and purification processes, as well as in the
development and registration of biopharmaceutical products.
BioMedicines desires to have BI Pharma KG personnel evaluate the
performance of the IFN-OMEGA production processes and sterile liquid filling of
the resulting product in BI Pharma KG's facilities and according to the
provisions of this Agreement hereinafter to manufacture IFN-OMEGA for clinical
trial and commercial purposes.
AGREEMENT
IN CONSIDERATION OF the mutual covenants set forth in this Agreement,
BI Pharma KG and BioMedicines hereby agree as follows:
1. DEFINITIONS
1.1 "AFFILIATE" shall mean any corporation or business entity controlled
by, controlling or under common control with either BI or B/M, as the
case may be. For this purpose, control shall mean any of the
following:
(a) direct or indirect beneficial ownership of more than fifty percent
(50%) of the voting stock of such entity;
(b) a fifty percent (50%) or greater interest in the income of such
entity;
(c) a fifty percent (50%) or greater management control over a joint
venture; or
(d) any other relationship that, in fact, constitutes actual control.
1.2 "BIOMEDICINES" shall mean BioMedicines Inc. as laid down first above.
[ * ] = 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.
1.
1.3 "BI PHARMA KG" shall mean Boehringer Ingelheim Pharma KG as laid down first
above.
1.4 "BIOMEDICINES CONFIDENTIAL INFORMATION" shall mean all technical and other
information relating to the Product that is disclosed or supplied to BI
Pharma KG by BioMedicines pursuant to this Agreement whether patented or
unpatented, including, without limitation, trade secrets, know-how,
processes, concepts, experimental methods and results and business,
scientific plans and financial information or data and shall retroactively
include similar such BioMedicines confidential information previously
provided to BII under confidentiality obligation that BII subsequently
disclosed verbally or in writing to BI Pharma KG.
1.5 "CELL LINE(S)" shall mean a CHO DX B11-SS cell line currently designated
2-1C4 (or any similar cell line designated differently) and any other cell
line(s) developed pursuant to this Agreement.
1.6 "CERTIFICATE OF ANALYSIS" shall mean a document describing testing methods
and results, the accuracy of which has been certified by a party, to be
agreed upon between the parties in due time.
1.7 "EFFECTIVE DATE" shall mean the date first above written, which shall be
the effective date of this Agreement.
1.8 "GMP" shall mean the regulatory requirements for good manufacturing
practices promulgated by the United States Food and Drug Administration
(FDA) under the Federal Food, Drug and Cosmetic Act, as amended, 21 C.F.R,
Section 210 et seq. and 21 C.F.R. Section 600-610, as applicable, or any
manufacturing standards set now or in the future by the FDA or by the
currently applicable regulations, directives, or decisions of the European
Union (as now published in the OFFICIAL JOURNAL OF THE EUROPEAN COMMUNITY
(EC) or its successor publication or directed specifically to BI Pharma KG
by the appropriate regulatory authorities. Moreover, GMP shall be
understood to be the higher or more stringent of the FDA or EC standards as
mutually agreed by BI Pharma KG and BioMedicines.
1.9 "LICENSE AGREEMENT" Shall mean the License Agreement concluded between
BioMedicines and BII regarding IFN- OMEGA.
1.10 "MASTER CELL BANK (MCB)" shall mean reference deposit or collection of
ampoules of the Cell Line 2-1C4 (or other cell lines as described above in
Section 1.5) and that has currently been designated MCB 054 Th, and any
successor or substantially similar but differently designated cell line and
cell lines created pursuant to the Agreement.
1.11 "MANUFACTURERS WORKING CELL BANK(S) (MWCB)" shall mean BI Pharma KG's
collection of [ * ] serially subcultivated cells that will be derived from
the MCB. The MWCB'(s) will be used to establish seed cultures of the Cell
Line to initiate the 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.
2.
1.12 "PHASE I" shall mean all activities and work to be performed as laid down
in the Master Projectplan attached hereto as Appendix 1 ("Master Project
Plan Interferon Omega; Proposed Development Plan") which shall include
manufacturing for purposes of commercialisation.
1.13 "PHASE II" shall mean the future research and development activities and
work to be performed according to a future agreement of the parties hereto,
but excluding manufacturing for purposes of commercialisation.
1.14 "PROCESS" shall refer to a BI Pharma KG developed and owned process for
using the Cell Line, including defined procedures, equipment and analytical
methodologies for in-process control, release testing and Product
characterization, that has been used by BI Pharma KG to produce the Product
at the [*] fermentation scale, or, if and when applicable, the modified
process after adaptation to serum-free production by BI Pharma KG.
1.15 "PRODUCT" shall mean drug substance or final product of IFN-OMEGA produced
by the Cell Line(s) in accordance with the Process.
1.16 "PROJECT" shall mean the Phase I program described herein, in which BI
Pharma KG will establish, implement, upscale and evaluate the serum-free
Process at the respective fermentation scale in BI Pharma KG's facility and
equipment. The primary objectives of the Project will be to perform
registration runs at commercial scale in the BI Pharma KG facility,
successfully demonstrate that equivalent Product (i.e. Product meeting the
Specifications) can be reproducibly manufactured in BI Pharma KG's
facilities, and prepare the CMC part of a BLA registration dossier with all
relevant data generated in the Project. A proposed timeline for the Project
is included in Appendix 1.
1.17 "PROJECT FEE" shall have the meaning specified in Section 6 hereof.
1.18 "PROJECT MANAGER" shall have the meaning specified in Section 2.1 hereof.
1.19 "PROJECT TEAM" shall have the meaning specified in Section 2.2 hereof.
1.20 "START DATE" shall mean the date mutually agreed by BI Pharma KG and
BioMedicines, which is anticipated to be on or about 1 August 1998.
1.21 "SUBLICENSEE" shall mean a person or legal entity to which BioMedicines
grants a sublicense of some or all of the rights granted to BioMedicines
according to the License Agreement.
1.22 "BI PHARMA KG CONFIDENTIAL INFORMATION" shall mean all technical and other
information relating to the Cell Line, Process, Product and BI Pharma KG's
facilities and associated technologies that is disclosed or supplied to, or
used on behalf of, BioMedicines by BI Pharma KG pursuant to this Agreement,
whether patented or unpatented, including, without limitation, trade
secrets, know-how, processes, concepts, experimental methods and results
and business and scientific plans.
[ * ] = 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.
1.23 "SPECIFICATIONS" shall mean the specifications for the Product and the
respective test methods for release of drug substance and drug product as
mutually agreed by the Project Team, as such specifications may be amended
from time to time by mutual agreement of BioMedicines and BI Pharma KG
according to the further development of the Process and Product.
2. COOPERATION BETWEEN THE PARTIES IN THE COURSE OF THE PROJECT
2.1 DESIGNATION OF PROJECT MANAGER. BI Pharma KG and BioMedicines shall each
identify a Project Manager who will be responsible for communicating all
instructions and information concerning the Project to the other party.
Each Project Manager will be available on an agreed upon regular basis for
consultation at pre-arranged times during the course of the Project. In the
absence of the Project Manager, a substitute shall be appointed. Additional
modes or methods of communication and decision making may be implemented
with the mutual consent of each party.
2.2 COOPERATION. In the course of the Project, BI Pharma KG will at all times
take into consideration and implement the recommendations of BioMedicines
as long as they do not unreasonably and adversely influence other BI Pharma
KG biotech operations; in the absence of explicit instructions from
BioMedicines, BI Pharma KG shall be entitled to employ its reasonable
judgment in carrying out the Project. BI Pharma KG shall be entitled to
rely upon any instructions or directives provided by any BioMedicines
representative and BI Pharma KG shall not be responsible for the failure to
achieve any objective or the inability to adhere to any guideline if such
failure or inability is caused by events beyond the reasonable control of
BI Pharma KG or by instructions or directives provided by BioMedicines, if
any.
BI Pharma KG shall permit BioMedicines, from time to time upon at least
thirty (30) days' prior notice to BI Pharma KG to conduct audits at BI
Pharma KG's facilities used for the Project during BI Pharma KG's normal
business hours and at a reasonable frequency. While at any BI Pharma KG
facility, BioMedicines personnel shall comply with all applicable BI Pharma
KG security and safety policies and procedures.
3. BIOMEDICINES RESPONSIBILITIES.
3.1 GENERAL. BioMedicines will periodically and appropriately keep BI Pharma KG
informed of the status of its activities around the Product as long as the
same facilitate the development and manufacture of the Product according to
this Agreement.
3.2 SPECIFIC. As far as not specified herein the responsibilities of
BioMedicines are defined in the License Agreement and possibly other
separate agreements between BioMedicines and Boehringer Ingelheim
International GmbH (BII), BI Pharma KG, or other BII Affiliates as
appropriate.
4. BI PHARMA KG RESPONSIBILITIES
[ * ] = 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.
4.1 MASTER PROJECTPLAN INCLUDING PROJECT TIMELINE. In the course of this
Agreement BI Pharma KG shall perform the work and tasks as laid down and
detailed in the Master Projectplan including Project Timeline, attached as
Appendix 1 hereto. Any third party contractors that BI Pharma KG intends to
hire for the Project need the approval of BioMedicines, except for single
quality control tasks. Such quality control tasks and vendors will be
identified to BioMedicines.
4.2 DOCUMENTATION. As soon as the data and documents are available to BI Pharma
KG and needed for registration, as mutually agreed upon in the project
plan, BI Pharma KG shall provide BioMedicines with all CMC-parts of a
United States FDA Biologics License Application (BLA) or similar
document(s) for European Registration as may be required to enable and
facilitate regulatory approval(s) to market IFN-OMEGA: Such CMC-documents
shall be provided to BioMedicines in English, shall be complete and
accurate, and shall contain all data required to enable and facilitate
regulatory approval(s). The format(s) for such documents will be
appropriate for the regulatory agency in question and mutually agreed.
4.3 ADDITIONAL WORK. On request of BioMedicines BI Pharma KG shall perform
additional work to sustain the progress of the Project on conditions in
terms of money, time and scope to be subject to mutual agreement of the
parties hereto.
5. PROJECT TO BE CONDUCTED ON FIXED-FEE BASIS
The Project shall be conducted by BI Pharma KG for BioMedicines on fixed
fee basis, in consideration of payment by BioMedicines of the Project Fee
according to the Master Projectplan as laid down in Appendix 1.
BioMedicines acknowledges that the Project is experimental in nature and
that no favorable or useful result can be assured by BI Pharma KG.
Accordingly, BI Pharma KG shall not be responsible to BioMedicines for any
failure of fermentations except for
contamination of (a) batch(es) due to BI Pharma KG's mishandling or
inability to obtain useful yields (Definition) of Product
and the Project Fee shall be payable in full regardless of result unless
the Project is terminated prior to its scheduled completion pursuant to
Section 13 hereof.
6. PROJECT FEE
Subject to Section 5 above, BioMedicines shall pay BI Pharma KG a Project
Fee of [ * ] for the services provided in carrying out the Project. This
fee includes all fees for BI Pharma KG's work according to Article 4
hereof.
Disposal of organic and hazardous waste is included in the Project Fee. The
Project Fee shall be payable in installments, each non-refundable when
paid, as provided for in the Master Projectplan (Appendix 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.
5.
Each invoice shall be payable within 30 days following receipt thereof.
7. PROGRESS TO PHASE II
7.1 START OF A POSSIBLE PHASE II. If BioMedicines decides to conduct a Phase II
the parties will have to agree on the conditions thereof (in terms of time
and commercial conditions) in due time depending on the then prevailing
capacity of BI Pharma KG.
8. OWNERSHIP OF/LICENSE TO PROJECT DATA
8.1 TRANSFER OF PROJECT DATA. In consideration of the Project Fee, BI Pharma KG
shall execute the Project in a timely manner (as further detailed in the
Appendices) and shall make available to BioMedicines in a timely manner all
information, data, or materials obtained or developed in the course of the
Project necessary to evaluate, test, develop, register, market, or sell the
Product.
8.2 INTERIM REPORTS. BI Pharma KG agrees to provide interim reports to
BioMedicines on a reasonable basis (max. quarterly basis).
8.3 LICENSE FOR THE USE OF PROJECT DATA. BioMedicines, its Affiliates or
Sublicensees shall have a worldwide, royalty-free, exclusive license, with
the right to sublicense, to Product-specific information and a
non-exclusive license to otherwise non-Product-specific information (i.e.,
information that may also apply to other projects/products) to use BI
Pharma KG Confidential Information that is used in carrying out the Process
to evaluate, test, develop, register, market, and sell the Product. These
licenses, and sublicenses if any, shall expire automatically at the same
time when the License Agreement expires.
9. COMMERCIAL PRODUCTION AND SUPPLY
9.1 BI PHARMA KG'S RIGHT AND OBLIGATION TO COMMERCIAL PRODUCTION AND SUPPLY.
The parties acknowledge and agree that, in case BioMedicines decides to
commercialize the Product, BI Pharma KG has an exclusive right and
obligation to produce and supply commercial quantities of Product (in bulk
drug, final product and/or finished product form) for BioMedicines within
the respective capacity of BI Pharma KG and the parties shall negotiate in
good faith and consummate a supply agreement at the earliest reasonable
opportunity for the supply by BI Pharma KG of commercial quantities of the
respective Product for the term of the License Agreement.
9.2 TERMS AND CONDITIONS. Such supply agreement shall contain terms and
conditions customary for such a supply agreement and shall be concluded
between BioMedicines and BI Pharma KG or, at the sole discretion of BI
PHARMA KG, with BII or any other Affiliate of BI Pharma KG as the case may
be, provided however, that the main production activities shall remain at
BI Pharma KG.
9.3 BI PHARMA KG'S INABILITY TO MANUFACTURE. Should BI Pharma KG be unable for
any reason to manufacture sufficient quantities of Product, BI Pharma KG
will take all
[ * ] = 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.
necessary or desirable steps to facilitate the manufacture of Product by
BioMedicines or by a third party.
9.4 BIOMEDICINES FORECAST/CAPACITIES/EXCEEDING QUANTITIES. In Appendix 2
BioMedicines has laid down its present forecast estimation of its, its
Affiliates and Sublicensees total requirements of Product. This forecast is
non-binding; however, BI Pharma KG's capacity planning for commercial
supply is based on and limited by BioMedicines's forecast.
If, for good reason, BI Pharma KG cannot produce and supply all requested
commercial quantities of Product as outlined in BioMedicines forecast
referenced above for whatever reason, BioMedicines will have the right to
have the missing quantities, as long as BI Pharma KG is not able to produce
and supply the respective quantities, produced elsewhere.
Moreover, the supply agreement shall provide for minimum quantities as
follows:
per order for commercial supplies: [ * ] of Product and
Per calendar year: ________ [ * ] of Product (to be agreed upon
between the parties at a later stage of
the cooperation at the earliest
reasonable opportunity and depending on
BioMedicines's forecast for commercial
supply and BI Pharma KG's capacity
planning resulting therefrom.
BI Pharma KG's will provide a reserved capacity for BioMedicines for a
certain amount of Product per calendar year based on the product
assumptions. This capacity may be increased by mutual agreement between the
parties with a lead time of no more than [ * ].
9.5 PRICING. The pricing for the Product manufactured and supplied under the
supply agreement to be concluded (see Section 9.1 above) shall take place
in accordance with the License Agreement.
10. REPRESENTATIONS, WARRANTIES AND INDEMNIFICATION.
10.1 BIOMEDICINES. BioMedicines hereby represents, warrants and agrees that:
(a) BioMedicines has full corporate authority to enter into this Agreement
and this Agreement is binding upon BioMedicines in accordance with its
terms; and
(b) BioMedicines shall indemnify, defend and hold BI Pharma KG, its
affiliates, and their respective officers, employees and agents
harmless from and against all losses, damages, costs and expenses
(including, without limitation, reasonable attorneys' fees), including
injury to persons or damage to property resulting from any breach of
the representations and warranties made by BioMedicines under this
Section, or as a result of any claim, except for willful or knowing
violation of
[ * ] = 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.
7.
third party intellectual property rights by BI Pharma KG, of
infringement of the intellectual property rights of a third party
based upon BI Pharma KG's activities in implementing the Process or
producing the Product in accordance with the instructions and
documentation provided by BioMedicines or developed in the course of
the Project.
10.2 BI PHARMA KG. BI Pharma KG hereby represents, warrants and agrees that:
(a) BI Pharma KG is the owner of the facilities and BI Pharma KG
Confidential Information to be used for purposes set forth in this
Agreement;
(b) BI Pharma KG is not aware of any special or unusual hazards that would
arise as a result of its carrying out of the Project as planned;
(c) BI Pharma KG has full corporate authority to enter into this Agreement
and this Agreement is binding upon BI Pharma KG in accordance with its
terms; and
(d) BI Pharma KG shall indemnify, defend and hold BioMedicines and its
officers, employees and agents harmless from and against all losses,
damages, costs and expenses (including, without limitation, reasonable
attorneys' fees), including injury to persons or damage to property,
resulting from any breach of the representations and warranties made
by BI Pharma KG under this Section, or as a result of any claim that
BI Pharma KG has violated any local law, ordinance, or guideline in
carrying out its biotechnical manufacturing responsibilities under
this Agreement or as a result deliberate misconduct or gross
negligence in the duties of BI Pharma KG under the terms of the
Agreement.
(e) BI Pharma KG will not knowingly infringe upon the intellectual
property rights of BioMedicines or any third party.
(f) BI Pharma KG will conduct all manufacture of Product for clinical
phase III trials according to manufacturing standards set by the
currently applicable regulations, directives or decisions of the
European Union (as now published in the Official Journal of the
European Community or its successor publication).
(g) BI Pharma KG has conducted the positive preliminary work with regard
to the serum-free process.
(h) BI Pharma KG will conduct the Project as described to BioMedicines and
that any documentation of Project results or procedures provided to
BioMedicines by BI Pharma KG shall be accurate in all material
respects.
10.3 NO ADDITIONAL WARRANTY. BI Pharma KG shall provide the results of the
Project to BioMedicines without any additional warranty of any kind,
express or implied, including, without limitation, any warranties of
merchantability or fitness for a particular purpose.
[ * ] = 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.
11. LIABILITY
11.1 LIMITATION OF LIABILITY. Other than BI Pharma KG generally knowing that
BioMedicines will be using the Product in clinical trials, BI Pharma KG has
no knowledge or awareness of or control over the manner in which
BioMedicines intends to use any Product or results obtained in the Project.
BI Pharma KG shall not be liable to BioMedicines for any losses, damages,
costs or expenses of any nature incurred or suffered by BioMedicines or by
a third party, arising out of any dispute or other claims or proceedings
made by or brought against BioMedicines in respect of the results of the
Project, or the use of any Product by BioMedicines or by a third party
(including, without limitation, product liability claims and claims by a
third party alleging infringement of its intellectual property rights), nor
shall BI Pharma KG be responsible in any way for dealing with any such
disputes, claims or proceedings except insofar as such losses, damages,
costs, expenses, claims or dealings shall be the result of actions by BI
Pharma KG, its personnel, or its agents that represent deliberate
misconduct or constitute gross negligence.
Notwithstanding the foregoing, BI Pharma KG shall remain liable for its
actions and the consequences thereof in the event that BI Pharma KG
knowingly infringes upon the intellectual property rights of BioMedicines
or any third party.
BioMedicines shall indemnify, defend and hold BI Pharma KG, its Affiliates
and their respective officers, employees and agents harmless from and
against all such losses, damages, costs and expenses (including, without
limitation, reasonable attorneys' fees) except insofar as such losses,
damages, costs, expenses, claims or dealings shall be the result of actions
by BI Pharma KG, its personnel, or its agents that represent deliberate
misconduct or constitute gross negligence.
11.2 SPECIAL LIMITATION OF LIABILITY. Notwithstanding Art. 10.2/10.3 above, BI
Pharma KG shall in no way be liable for the correctness, usefulness and
operatability of material and data (such as cellbanks, reagents etc.)
received from BioMedicines, if any.
11.3 MAXIMUM AMOUNT. BI Pharma KG undertakes to use its best efforts to perform
the Project under the Master Projectplan and to meet the target dates set
forth in Appendix 1 hereto. However, due to the biological nature of the
work to be performed hereunder BI Pharma KG's liability under this
Agreement shall in no event amount to more than [*] of the Project Fee due
for the entire Project according to Articles 5 and 6 above. The maximum of
[*] shall not apply to liabilities resulting from deliberate misconduct by
BI Pharma KG.
12. CONFIDENTIALITY
12.1 BI PHARMA KG. BI Pharma KG shall not disclose BioMedicines Confidential
Information to any person other than its employees or employees of its
Affiliates who have a need to know such information in order to perform
their duties in carrying out the Project hereunder. All other disclosures
need the prior approval of BioMedicines.
[ * ] = 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.
9.
12.2 BIOMEDICINES. BioMedicines shall not disclose any BI Pharma KG Confidential
Information to any person other than its employees, directors, or
consultants who are bound by similar obligations of confidentiality and who
have a need to know such information in order to provide direction to BI
Pharma KG or evaluate the results of the Project.
12.3 EXCEPTIONS TO CONFIDENTIALITY. The obligations of confidentiality
applicable to BioMedicines Confidential Information and BI Pharma KG
Confidential Information shall not apply to any information that is:
(a) known publicly or becomes known publicly through no fault of the
recipient;
(b) learned by the recipient from a third party entitled to disclose it;
(c) developed by the recipient independently of information obtained from
the disclosing party;
(d) already known to the recipient before receipt from the disclosing
party, as shown by its prior written records;
(e) required to be disclosed by law, regulation or the order of a judicial
or administrative authority (E.G. regulatory authorities, for example,
the FDA, that require such information in order to review an IND or
other regulatory filing); or
(f) released with the prior written consent of the disclosing party.
12.4 OTHERS. No right or license, either express or implied, under any patent or
proprietary right is granted hereunder by virtue of the disclosure of
BioMedicines Confidential Information or BI Pharma KG Confidential
Information. Either party shall be entitled to injunctive relief in the
event of a breach of this Agreement by the other party. The obligations of
both parties under this Section 11 shall survive the expiration or
termination of this Agreement. Both BioMedicines and BI Pharma KG shall use
reasonable and customary precautions to safeguard BioMedicines Confidential
Information and BI Pharma KG Confidential Information, including ensuring
that all employees, consultants, directors, agents, or the like who are
provided access to such information are informed of the confidential and
proprietary nature of such information and understand that all such
information is required to be maintained confidential.
13. TERM AND TERMINATION
13.1 TERM. This Agreement shall, unless terminated earlier, commence as of the
Effective Date and shall expire upon the date of payment of the last sum
due hereunder, or upon the date when the last services required to be
performed hereunder are performed, whichever date shall last occur.
[ * ] = 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.
10.
13.2 RIGHT TO TERMINATE. If it becomes apparent to either party at any stage of
the Project that it will not be possible to carry out the Project for
scientific or technical reasons or as a result of Force Majeure, the
parties shall permit thirty (30) days for discussion to resolve, if
possible, the scientific or technical issue giving rise to the problem. If
the parties fail to resolve the problem, either party shall have the right
to terminate this Agreement, effective upon written notice to the other. In
the event of such termination, the amount due to BI Pharma KG hereunder
shall include all expenses reasonably incurred by BI Pharma KG prior to
such termination in respect of the purchase of supplies or raw materials,
and an allocation of the balance of the Project Fee for the period prior to
receipt of such termination by BI Pharma KG and for a period of [*]
weeks thereafter. The amount to be paid per week in this case shall be
calculated separately Phase by Phase by dividing the amount to be paid by
BioMedicines for the respective entire Phase by the number of weeks of the
respective Phase. Such the amount per week may vary if the six week period
reaches into the next Phase. However, under no circumstances BioMedicines
shall be obliged to pay more than the amount that would have been due
ordinarily for the respective Phase.
13.3 TERMINATION WITH IMMEDIATE EFFECT. Either party may terminate this
Agreement effective upon written notice if either of the following events
occurs.
(a) The other party commits a breach of this Agreement and the breach is
not remedied within 30 days after the receipt of notice identifying
the breach and requiring its remedy; or
(b) The other party (I) becomes unable to pay its debts as they become
due, (II) suspends payment of its debts, (III) enters into or becomes
subject to corporate rehabilitation or bankruptcy proceedings or
liquidation or dissolution, (IV) makes an assignment for the benefit
of its creditors or (V) seeks relief under any similar laws for
debtor's relief.
(c) If the License Agreement terminates for whatsoever reason.
13.4 EFFECT OF TERMINATION. Upon the expiration or termination of this
Agreement:
(a) At the request of BioMedicines, BI Pharma KG shall promptly return all
BioMedicines Confidential Information to BioMedicines; except for a
single copy and/or sample of each material for documentation purposes
only. BI Pharma KG's responsibility to keep and store the Cell Line
and any other material shall terminate [*] months after expiration
or termination of this Agreement; and
(b) BioMedicines shall promptly return all BI Pharma KG Confidential
Information to BI Pharma KG, except for a single copy and/or sample
for documentation purposes only.
The respective rights of BI Pharma KG and BioMedicines to indemnification
as set forth in Section 9 hereof shall survive termination of this
Agreement with respect to any claims
[ * ] = 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.
11.
that relate to or derive from the Project, or any acts or failures to act,
of either BI Pharma KG or BioMedicines in connection with the Project that
occur prior to termination.
14. FORCE MAJEURE. Neither party shall be in breach of this Agreement if there
is any failure of performance under this Agreement (except for payment of
any amounts due hereunder) occasioned by any act of God, fire, act of
government or state, war, civil commotion, insurrection, embargo,
prevention from or hindrance in obtaining energy or other utilities, labor
disputes of whatever nature or any other reason beyond the control of
either party.
15. PUBLICITY. No press release or other form of publicity regarding the
Project or this Agreement shall be permitted by either party to be
published unless both parties have indicated their consent to the form of
the release in writing.
16. NOTICES. Any notice required or permitted to be given hereunder by either
party shall be in writing and shall be (a) delivered personally, (b) sent
by registered mail, return receipt requested, postage prepaid or (c)
delivered by facsimile with immediate telephonic confirmation of receipt,
to the addresses or facsimile numbers set forth below:
If to BI Pharma KG: Boehringer Ingelheim Pharma KG
Xxxxxxxxxxxx Xxxxxxx 00
88397 Biberach an der Riss
Federal Republic of Germany
Attention: Prof. Xx. Xxxx X. Xxxxxx
Fax: 0 73 51/54-51 31
Phone 0 73 51/54-48 00
If to BioMedicines: BioMedicines, Inc.
000 Xxxxxx Xxxxxxx Xxxxxxx, Xx. 000
Xxxxxxx, XX 00000 XXX
Fax:
--------------------------------
Phone:
------------------------------
Each notice shall be deemed given (a) on the date it is received if it is
delivered personally, (b) 1 day after the date it is postmarked if it is
sent by certified United States mail, return receipt requested, postage
prepaid or by other commercial carrier such as DHL (c) on the date it is
received if it is sent by facsimile with immediate telephonic confirmation
of receipt. Notice to BioMedicines shall be deemed to constitute notice to
and for purposes of this Agreement.
17. APPLICABLE LAW
This Agreement shall be governed by and construed in accordance with the
laws of the place of domicile of BI Pharma KG and the courts of the place
of domicile of BI Pharma KG shall have exclusive jurisdiction over all
legal matters and proceedings hereunder.
[ * ] = 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.
12.
18. COMPLIANCE WITH LAWS
BI Pharma KG shall perform the work hereunder in conformance with GMP, as
applicable, and all German laws, ordinances and governmental rules or
regulations pertaining thereto.
19. INDEPENDENT CONTRACTORS
Each of the parties hereto is an independent contractor and nothing herein
contained shall be deemed to constitute the relationship of partners, joint
ventures, nor of principal and agent between the parties hereto. Neither
party shall hold itself out to third persons as purporting to act on behalf
of, or serving as the agent of, the other party.
20. WAIVER
No waiver of any term, provision or condition of this Agreement whether by
conduct or otherwise in any one or more instances shall be deemed to be or
construed as a further or continuing waiver of any such term, provision or
condition or of any other term, provision or condition of this Agreement.
21. SEVERABILITY
If any provision of this Agreement is held to be invalid or unenforceable
by a court of competent jurisdiction all other provisions shall continue in
full force and effect.
22. ENTIRETY
This Agreement, including any exhibits and appendices attached hereto and
referenced herein, constitutes the full understanding of the parties and a
complete and exclusive statement of the terms of their agreement, and no
terms, conditions, understandings or agreements purporting to modify or
vary the terms thereof shall be binding unless it is hereafter made in
writing and signed by both parties.
23. ASSIGNMENT
This Agreement shall be binding upon the successors and assigns of the
parties and the name of a party appearing herein shall be deemed to include
the names of its successors and assigns provided always that nothing herein
shall permit any assignment by either party. However, BI Pharma KG may
assign this Agreement to any suitably qualified Affiliate of BII.
[ * ] = 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.
13.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed as of
the Effective Date.
BIOMEDICINES, INC. BOEHRINGER INGELHEIM PHARMA KG
By: /s/ X. X. XXXXX ppa. ppa.
--------------------------- /s/ Xxxx Xxxxxx /s/ Michelberger
Title: X.X. Xxxxx, M.D.
Chief Executive Officer Prof. Xx. Xxxx X. Xxxxxx Xx. Xxxxxxxxxxxx
(Head of Biotechnical (Head of Legal Dept)
Manufacture)
Date 23 July 1998 Date July 17, 1998
APPENDICES:
Appendix 1 Master Projectplan including Project Timeline
Appendix 2 BioMedicines present forecast estimation of its
Affiliates and Sublicensees total requirements 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.
14.
[BOEHRINGER INGELHEIM LOGO]
APPENDIX 1
(Page I of 3)
COST ESTIMATE OF THE MASTER PROJECT PLAN INTERFERON OMEGA
[*]
[ * ] = 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.
[ * ]
[ * ] = 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.
[ * ]
[ * ] = 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.
[BOEHRINGER INGELHEIM LOGO]
APPENDIX 2
BIOMEDICINES PRESENT FORECAST ESTIMATION OF ITS, ITS AFFILIATES AND
SUBLICENSEES TOTAL REQUIREMENTS OF PRODUCT
1. [ * ] ug/[ * ]
2. [ * ] per week per [ * ]-week treatment cycle
3. [ * ] cycle per year per patient
4. year 1: [ * ] patients = [ * ] cycles = [ * ]
5. year 2: [ * ] patients = [ * ] cycles = [ * ]
6. year 3: [ * ] patients = [ * ] cycles = [ * ]
7. In year 1, an additional [ * ]
will be needed to provide
a reserve of drug in the pharmacies;
in year 2 an additional [ * ]
will be needed to provide a reserve
of drug in the pharmacies; and
in year 3 an additional [ * ]
will be needed to provide a reserve
of drug in the pharmacies
8. phase IV testing will require an additional [ * ] per year
[ * ] = 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.
