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Exhibit 10.7
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LETTER AMENDMENT TO THE OMEGA INTERFERON LICENSE AGREEMENT
BioMedicines, Inc.
1301 Marina Village Parkway
Suite 200
Alameda, CA 94501
U.S.A.
21 February 2000
Dear Sirs:
Under an Agreement dated July 17, 1998, Boehringer Ingelheim International GmbH
("BII") has granted BioMedicines, Inc. ("BMI") certain rights to formulations of
Omega Interferon (the "Agreement") and BMI is commencing clinical trials with
one such formulation. This letter Amendment is to confirm the agreement between
BII and BMI to more specifically define the rights granted in relation to new
dosage forms and indications.
Therefore, BII and BMI hereby agree as follows:
A. Definitions: All capitalised items not otherwise defined in this letter
Amendment shall have the meaning given to them in the Agreement.
B. Section 1.3 is amended to read as follows: "1.3 "FIELD" shall mean the
treatment of humans by the administration of Licensed Product for
diseases, disorders, conditions and the like except multiple
sclerosis."
C. Section 1.6 is amended to read as follows: "1.6 "LICENSED PRODUCT"
shall mean one or more pharmaceutical products initially developed by
BII and containing Omega Interferon (which is described more fully in
Appendix A), including all such products suitable for administration
[ * ] whether or not initially developed by BII, and for use in the
Field, including new formulations, if any, developed by BII or BMI
after the Effective Date."
D. A new Section 2.4 is added as follows: "2.4 BII agrees to inform BMI in
advance before BII grants rights to any [ * ] of Omega Interferon to
any third party and to discuss any possible conflict between BMI and
such third party. BII agrees to exclude the indications [ * ] from any
such rights granted to a third party. Any agreement between BII and
such third party will provide for a fair compensation to BMI in the
event such third party benefits from [ * ] at BMI's expense under the
R&D Agreement."
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E. The beginning of the first sentence of Section 5.2.3 is amended to read
as follows: "5.2.3 "RIGHTS OF FIRST REFUSAL" Within thirty (30) days
after receiving from BMI the final clinical trial report for one of the
clinical studies described in Appendix D..."
The definition of "Reversion Terms" in Section 5.2.3 is extended by
adding a new sentence as follows: "Reversion Terms" shall also apply to
development of the [ * ] referred to in Section 5.2.4 (new) and the
[ * ] referred to in Section 5.2.5 (new) as the case may be."
F. New Sections 5.24. and 5.2.5 are added:
"5.2.4 "[ * ]" If BMI develops an [ * ] of Licensed Product, than
within thirty (30) days after receiving from BMI both the final
preclinical report for a study reporting the results of [ * ] testing
in an [ * ] of Omega Interferon and the results of one of the clinical
trials pursuant to Section 5.2.3, BII shall inform BMI in writing
whether it wishes to negotiate the reversion of some or all of the
rights granted to BMI under this Agreement in the countries of the
Territory except for countries where BMI has granted a Sublicense under
Clause 5.2.2. If BII does so wish, then both BMI and BII agree to
negotiate in good faith for no more than an additional sixty (60) days
the Reversion Terms. Until the expiration of this sixty (60) day
period, BMI may not conclude a Sublicense agreement with any third
party except for countries in Asia pursuant to Section 3.2. Discussions
shall then continue as described in paragraphs 2 and 3 of Clause
5.2.3."
"5.2.5 "[ * ]" If BMI develops a [ * ] for Licensed Product, then
within thirty (30) days after receiving from BMI both the final [ * ]
report referred to in Appendix F and the results of one of the clinical
trials pursuant to Section 5.2.3, BII shall inform BMI in writing
whether it wishes to negotiate the reversion of some or all of the
rights granted to BMI under this Agreement in the countries of the
Territory except for countries where BMI has granted a Sublicense under
Clause 5.2.2. If BII does so wish, then both BMI and BII agree to
negotiate in good faith for no more than an additional sixty (60) days
the Reversion Terms. Until the expiration of this sixty (60) day
period, BMI may not conclude a Sublicense agreement with any third
party except for countries in Asia pursuant to Section 3.2. Discussions
shall then continue as described in paragraphs 2 and 3 of Clause
5.2.3.".
G. Section 5.3 is revised as follows: "5.3 "ONE-TIME RIGHTS" Both BII and
BMI agree that the reversion rights described in Section 5.2.3, 5.2.4
and 5.2.5 shall be "one-time" rights only and shall expire following
the earliest of the following independent and mutually exclusive
events:
a. the decision by BII to decline to review the
report regarding one of the clinical studies of
Appendix D or the preclinical reports of
Sections 5.2.4 or 5.2.5 as the case may be; or
b. the end of the thirty (30)-day period referred
to in Section 5.2.3, 5.2.4 or 5.2.5 as the case
may be but then if, and only if, BII has not
yet
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informed BMI in writing of BII's wish to
negotiate Reversion Terms; or
c. the end of the sixty (60)-day negotiation
period referred to in Section 5.2.3, 5.2.4 or
5.2.5 as the case may be but then if, and only
if, BII and BMI have not yet agreed on said
Reversion Terms."
H. A new sentence is added at the end of Section 6.2: "The obligation to
provide such written reports shall also apply to [ * ] of Omega
Interferon developed by BMI during the term of this Agreement."
I. Wherever the word "trial" appears in Section 7.1., 7.2 and 7.3 it is
replaced by the word "trials."
J. The second sentence of Section 7.4 is amended to read as follows: "BII
through its Affiliate BI Austria (formerly Bender and Co. GmbH) or BI
Pharma KG, agrees to supply BMI at mutually agreed intervals, to be
laid down in the R&D Agreement, additional [ * ] of Licensed Product or
matching Placebo subject for each batch of [ * ] to the stability and
release for clinical trials of the Omega Interferon drug substance
batches which were available at BI Austria on the Effective Date."
K. New Sections 7.6 and 7.7 are added:
"7.6 "BULK DRUG SUBSTANCE." BII shall supply to BMI [ * ] of Omega
Interferon bulk substance. BMI agrees to use such bulk substance
exclusively for [ * ] as described in Appendix E and a [ * ] as
described in Appendix F. BMI acknowledges that this bulk drug substance
has not been released for use in humans."
7.7 "ADDITIONAL SUPPLIES OF BULK DRUG SUBSTANCE." One completion of
the [ * ] studies described in Appendices E and F and the clinical
trials in Appendix D, BMI will inform BII in each case of its
interest in proceeding with the development of each [ * ] BMI shall
inform BII on the proposed changes with respect to bulk drug
substance and final [ * ] supply requirements, based on the results
from such studies. Within sixty days upon receiving such information
BII or BI Pharma KG shall prepare a proposal on further drug supply
for the support of clinical trials. If appropriate, BMI shall
negotiate with BII or BI Pharma KG in good faith the terms for BII
or BI Pharma KG to supply BMI with committed quantities of bulk drug
substance and drug product for further development. BMI and BI
Pharma KG will also agree on a new project plan and on the
conditions of supply in terms of feasibility, time, costs and
workscope to be laid down as an Amendment to the R&D Agreement.
Notwithstanding the second paragraph of Section L, BMI and BI Pharma
KG will also agree to the terms for the transfer of BI Pharma KG's
rights and obligations to manufacture sustained release injectable
drug product to BMI and/or a third party.
L. A new Section 7.8 is added as follows: "7.8 "[ * ]." Within sixty (60)
days after BMI has provided BII with all relevant information regarding
its plans for development of a [ * ] including product requirements,
expected market size and manufacturing technology, the
[ * ]CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
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Parties will negotiate in good faith the basic terms of a supply
agreement including prices for commercial supplies, minimum orders,
reserved capacity at BII and commitments to purchase by BMI. A detailed
supply agreement will be concluded at the latest [ * ] prior to the
launch of each Licensed Product.
At its sole discretion, BI Pharma KG may decide to exercise its rights
to manufacture [ * ] under Section 9 of the R&D Agreement by describing
the CMC information for regulatory submissions in the form of a master
file. BMI agrees to ensure that such BI Pharma KG rights are
acknowledged in any BMI agreements with third parties on the
development of new dosage forms."
M. Appendix D is updated and consists of the 3 BMI protocols dated
19.04.1999, 15.09.1999 and 18.09.1999.
N. Two new Appendices are added:
"E. Development of [ * ]
F. Development of [ * ]"
Best regards
Boehringer Ingelheim
International GmbH
pps.
/s/ Dr. D. Mitchard
Dr. C. Hauke Dr. D. Mitchard
Please acknowledge your agreement to the above letter Amendment by signing below
where indicated.
BioMedicines, Inc.
By: /s/ S M Moran
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Name: SM Moran, M.D.
--------------
Title: Chief Executive Officer
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24 FEBRUARY 2000
[ * ]CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
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APPENDIX E
[ * ] RESEARCH PLAN
BioMedicines, Inc. (BMI) and [ * ] have executed an agreement to explore the
feasibility of developing an [ * ] of omega interferon. [ * ] will utilize
patented technology to [ * ] to produce [ * ]:
[ * ]
After generating up to [ * ] representative [ * ] will be examined with the
BM8233 commercial assay for quantitating omega interferon. BMI will supply the
assay and methodology. [ * ] will establish the assay in its facilities.
In addition, these [ * ] will be assayed for bioactivity. Currently, the two
companies intend to develop the A549-EMCV bioassay utilizing cells and virus
obtained from the U.S. ATCC and methods to be developed by the two companies. It
is anticipated, however, that the assay system will be established in a
Biohazard 3 capable laboratory extrinsic to both companies. The most probable
sites are [ * ]. Final selection of a bioassay laboratory will be made at a
later date.
If a suitable [ * ] can be identified which is both [ * ], the molecule will be
[ * ] to permit testing of [ * ]. Currently, [ * ] is utilizing a rodent model
developed collaboratively with [ * ]. In addition, BMI is now negotiating with [
* ].
The overview described above is necessarily brief and will be expanded during
the course of detailed planning and execution. Subsequent, more detailed plans
can be made available as they are developed. Currently, [ * ] and BMI expect to
pursue the activity-timetable shown on the following page.
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[ * ] ACTIVITY TIMETABLE
[ * ]
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APPENDIX F
[ * ] RESEARCH PLAN
Bio-Medicines, Inc. (BMI) and [ * ] have a non-binding agreement to explore the
[ * ] of omega interferon. [ * ] will utilize patented technology to produce
both a [ * ].
[ * ] has certain rights under license from the Alza Corporation. Currently the
[ * ] to develop a [ * ] will need to be obtained from [ * ]. BMI and [ * ] have
agreed upon a structure for the [ * ] and subsequent commercialization duties
and rewards, if any, for the [ * ].
The two companies have agreed in principle that a formal proposal will be made
to [ * ] once it is established that the [ * ] can be executed. BMI will provide
[ * ] and conduct the appropriate [ * ]. [ * ] will be responsible for
developing a [ * ] that is compatible with [ * ], will be responsible for [ * ]
will be conducted [ * ] to include a maximum of [ * ] will be the responsibility
of BMI. The principal goal will be to determine if omega [ * ].
The overview described above is necessarily brief and will be expanded during
the course of detailed planning and execution. Subsequent, more detailed plans
can be made available as they are developed. Currently, [ * ] and BMI expect to
pursue the activity-timetable shown on the following page.
[ * ]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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[ * ] ACTIVITY TIMETABLE
[ * ]
[ * ]CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
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