EXHIBIT 10.17
APPENDIX A
COLLABORATIVE DISCOVERY AND LEAD OPTIMIZATION AGREEMENT
This Collaborative Discovery and Lead Optimization Agreement (the "Agreement')
is made and effective as of December 17, 1999 (the "Effective Date"), by and
between 3-Dimensional Pharmaceuticals, Inc., a corporation having its principal
place of business at Eagleview Corporate Center, 000 Xxxxxxxx Xxxxx, Xxxxx 000,
Xxxxx, XX 00000, X.X.X. ("3DP'), and Boehringer Ingelheim Pharmaceuticals, Inc.,
a corporation having its principal place of business at 000 Xxxxxxxxx Xxxx,
Xxxxxxx, XX 00000, X.X.X. ("BIPI"). 3DP and BIPI may be referred to herein as a
"Party" or, collectively, as "Parties".
WHEREAS, 3DP is engaged in discovery research for a variety of biologically
active compounds and the development of technologies to facilitate such
research, and 3DP has patented systems for generating chemical compounds having
desired pharmaceutical properties;
WHEREAS, BIPI is engaged in research and development of human therapeutic
products;
WHEREAS, 3DP and BIPI desire to enter into a research and development
collaboration to identify qualified lead compounds active against selected
targets and suitable for medicinal chemistry optimization that may be developed
and commercialized by BIPI;
NOW, THEREFORE, in consideration of the various promises and undertakings set
forth herein, the Parties agree as follows:
1. DEFINITIONS
Unless otherwise specifically provided herein, the following terms shall have
the following meanings, and may be used in the singular or plural, as indicated
by their context:
1.1 "Active Compound" means a Qualified Lead Compound or a compound
derived from a Qualified Lead Compound that has been formally selected
by BIPI after recommendation by the Research Steering Committee for
preclinical development as evidenced by initiation of a BIPI supported
range finding toxicology study to be performed by the BIPI Toxicology
Department or its designate.
1.2 "Affiliate" of a Party means: (a) any corporation owning or directly
or indirectly controlling at least fifty percent (50%) of the stock
normally entitled to vote for election of directors of a party, and
(b) any corporation owned or directly or indirectly controlled by a
party, or by a corporation defined by subparagraph (a) above, through
ownership of at least fifty percent (50%) of stock normally entitled
to vote for election of directors.
1.3 "Agreement" shall mean the present agreement including its appendices.
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1.4 "Confidential Information" means all information that has or could
have commercial value or other utility In a Party's business, or the
unauthorized disclosure of which could be detrimental to the Party's
interests, including confidential information, inventions, know-how,
data and materials relating to the Research Program or to the Licensed
Products, and shall include without limitation research, technical,
clinical development, manufacturing, marketing, financial, personnel
and other business information and plans, whether in oral, written,
graphic or electronic form.
1.5 "Custom Accessible Libraries" means any DirectedDiversity(R) Chemical
Library produced using 3DP DirectedDiversity(R) Technology and
structure activity data provided by BIPI.
1.6 "DirectedDiversity(R) Chemical Library" means a computer-generated
library of compounds containing integrated structure-activity and
synthesis data.
1.7 "Effective Date" means the effective date of this Agreement as set
forth in the first paragraph hereof.
1.8 "Field" means human therapeutic and diagnostic uses of Qualified Lead
Compounds or Active Compounds against Targets.
1.9 "Licensed Product" means any commercial product containing an Active
Compound.
1.10 "Net Sales" means the gross invoiced sales price charged to third
parties for all Licensed Products sold by BIPI and its Affiliates
after deduction of the following items: (a) customary trade, quantity
and case discounts, wholesaler-charge backs, or rebates (including
rebates to governmental agencies); provided that such discounts,
charge backs and rebates are not applied disproportionately with
respect to particular products sold; (b) customary credits or
allowances for rejection or return of previously sold Licensed
Products; (c) any direct tax or government charge (other than an
income tax) levied on the sale, transportation or delivery of a
Licensed Product and borne by the seller thereof; and (d) any charge
for freight or insurance if separately stated.
Combination Products: Where Product is sold in the form of a
combination product containing one or more active ingredients in
addition to an Active Compound, Net Sales for such Combination Product
will be calculated by multiplying actual Net Sales of such combination
Product by the fraction A/(A+B) where A is the net invoice price of
Product to an end use customer containing such Active Compound, if
sold separately, and B is the net invoice price of a product to an end
use customer containing any other component or components in the
combination, if sold separately. If, on a country-by-country basis,
the other active component or components in the combination are not
sold separately in said country, Net Sales for the purpose of
determining royalties on the Combination Product shall be calculated
by multiplying actual Net Sales of
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such Combination Product by the fraction A/C where A is the invoice
price of Product containing the Active Compound, if sold separately,
and C is the invoice price of the Combination Product. If, on a
country-by-country basis, neither the Product nor the other active
component or components of the Combination Product is sold separately
in said country, Net Sales for the purposes of determining royalties
of the combination Product shall be reasonably allocated between the
Product and the other active components based upon their relative
value as determined by the Parties hereto in good faith.
1.11 "Patents" means all U.S. patent applications or issued patents,
including provisionals, divisionals, continuations, continuations-in-
part, reissues and extensions derived therefrom, such as patent term
restorations, supplementary protection certificates, etc., as well as
all foreign patents and foreign patent counterparts to the foregoing.
1.12 "Qualified Lead Compound" means a chemical compound produced in the
course of the Program that satisfies criteria established by the
Research Steering Committee. A "3DP Qualified Lead Compound" means a
Qualified Lead Compound that is generated from a 3DP Accessible
Library. A "BIPI Qualified Lead Compound" means a Qualified Lead
Compound that is generated from a Custom Accessible Library.
1.13 "Research Program" means the collaborative discovery and optimization
activities of the Parties, as described in Article 2, that are
intended to lead to the discovery of Active Compounds that have an
agreed upon level of activity against a Target and are suitable for
pre-clinical and commercial development by BIPI.
1.14 "Research Program Patents" shall mean those Patents that claim
discoveries or inventions made as a result of the Research Program and
for a time period starting at the Effective Date through a period of
one year following the termination of the Research Program, regardless
of their ownership.
1.15 "Research Steering Committee" or "RSC" means the committee to be
formed pursuant to Article 3 of this Agreement.
1.16 "Target" means a protein, to be selected by the Senior Vice President
of R&D at BIPI, against which Qualified Lead Compounds and Active
Compounds are to be developed. Notwithstanding the above, 3DP may
reject a Target proposed by the Senior Vice President of R&D under the
following circumstances: (a) 3DP has entered into a contractual
relationship with a third party regarding the proposed Target or a
substantially similar Target; (b) other reasonable legal grounds; or
(c) 3DP has already selected the proposed Target or a substantially
similar Target for its internal research and development program as
may reasonably be demonstrated by 3DP.
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1.17 "Territory" means the entire world."3DP Accessible Libraries" means
any DirectedDiversity(R) Chemical Library that is generated by 3DP
outside of the Research Program.
1.18 "3DP DirectedDiversity(R) Technology" means 3DP Patents and know-how
in effect at the time of the Effective Date of this Agreement that
relate to generating and utilizing a DirectedDiversity(R) Chemical
Library, including but not limited to U.S. Patent Nos. 5,463,564,
5,574,656, 5,684,711 and 5,901,069. This term also includes any
discoveries, improvements, inventions and modifications made during
the Research Program to the extent that they relate to 3DP
DirectedDiversity(R) Technology. This term does not include the SAR
models as described in Article 2 of this Agreement.
1.19 "3DP Patents" means any Patents owned or controlled by 3DP other than
Research Program Patents.
1.20 "Valid Claim" means a claim of a Patent that has not lapsed or become
abandoned or been declared invalid or unenforceable by a court or
agency of competent jurisdiction from which no appeal can be or has
been taken.
2. RESEARCH PROGRAM
2.1 General Project Description. The Parties contemplate that the Research
Program will include the following steps and activities:
(a) BIPI will furnish to 3DP the structure and activity data on
chemical compounds screened against a Target that BIPI feels are
necessary for analysis of a Structure Activity Relationship
("SAR").
(b) 3DP will use its DirectedDiversity(R) Technology to compute a
chemical descriptor matrix to describe and map the compounds for
which BIPI provides data. 3DP also will develop an SAR model
based on this descriptor matrix for hits.
(c) 3DP will compare the SAR model with compounds in 3DP Accessible
Libraries, 3DP will identify [**] compounds to be synthesized by
3DP and supplied to BIPI for testing. 3DP will supply between
[**] milligrams of each such compound in 96 deep well plates
(about 80 compounds per plate). These compounds will meet a
minimum purity of 80% (resolved LCMSA/NMR) for 80% of the
compounds provided. Upon request of BIPI, 3DP will provide
additional quality control for individual compounds.
(d) 3DP will provide BIPI with a secure internet based communication
channel to provide activity or other compound related data to
3DP.
**Certain portions of this Exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
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(e) 3DP will develop an improved SAR model based on the testing data
provided by BIPI. This improved SAR will be used to perform
iterative rounds of selection and synthesis of compounds from 3DP
Accessible Libraries, and/or to develop Custom Libraries from
which compounds will be selected and synthesized, and/or to
perform medicinal chemistry optimization and synthesis. Such
compounds will be supplied to BIPI for additional testing in
furtherance of the Research Program.
2.2 Development of Active Compounds. BIPI will conduct the preclinical and
clinical tests as it deems appropriate for the commercial development
in the Field of Active Compounds.
2.3 Initial Term and Extension of Research Program. The initial term of
the Research Program shall be two (2) years. BIPI may extend this
Agreement on an annual basis by notifying 3DP in writing at least
sixty (60) days prior to the end of the initial two (2) year term or
any extended one-year term then in effect.
2.4 Additional and Alternative Targets. BIPI, through the Research
Steering Committee, shall have the option to bring forward a total of
up to five (5) Targets at any one time or to change Targets upon
thirty (30) days advance written notice to 3DP.
3. RESEARCH PROGRAM GOVERNANCE
3.1 Research Steering Committee. 3DP and BIPI agree to establish a
Research Steering Committee of seven (7) people. BIPI shall designate
four (4) members and 3DP shall designate three (3) members, each
selected by their respective R&D management to form this Research
Steering Committee. The Research Steering Committee shall be
responsible for:
(a) Adopting, reviewing and amending the research plan to implement
the Research Program, subject to the approval of the Vice
President of Research at BIPI.
(b) Monitoring the progress of research in the Research Program.
(c) Reviewing initial Target and any subsequent Target selection.
(d) Recommending to the Vice President of Research at BIPI
designation of a compound as an Active Compound.
(e) Reviewing and approving publications and other public disclosures
related to the subject matter of the Research Program subject to
the approval of the Vice President of Research at BIPI.
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3.2 Management of Matters Outside the Jurisdiction of the Research
Steering Committee. Matters outside the scope of the Research Program
and internal to each Party are not under the purview of the Research
Steering Committee. Such matters include, but are not limited to the
following: internal personnel policies and programs, budgeting,
finance, commercial and marketing strategies, and business decisions.
However, the Parties agree to communicate with each other promptly on
those matters which, while outside the scope of the Research Program,
nevertheless may reasonably be expected to influence the conduct or
term of the Research Program or the intended commercialization of
Active Compounds. Furthermore the RSC does not have responsibility for
or the authorization to choose the number of FTEs assigned to the
Research Program as set forth in Section 4.1 (b).
4. FINANCIAL TERMS
4.1 Technology Access and FTE Reimbursement Fees.
(a) BIPI agrees to pay a nonrefundable technology access fee of [**]
due within thirty (30) days of the Effective Date of this
Agreement.
(b) BIPI agrees to pay 3DP in advance, on a calendar quarterly
basis, for the staff allocated by 3DP for the services to be
provided under this Agreement. These services will be
compensated by BIPI at a rate equivalent to the support for [**]
Full Time Equivalents ("FTEs"). The quarterly payment for the
initial term of the Research Program shall be [**]. Depending on
the total number of Targets designated and the number of 3DP
FTEs reasonably necessary to meet the objectives of this
Agreement, BIPI and 3DP shall negotiate in good faith to provide
additional compensation to 3DP in a form to be agreed upon by
the Parties, such as a lump sum payment or support by BIPI for
additional FTEs.
4.2 Extended Term Fees. The level of reimbursement for FTEs in an extended
term shall be negotiated in good faith by the Parties, and shall at
least reflect an increase to the FTE support level of Section 4.1 (b)
based on increases in the cost of living.
4.3 Early Termination Fees. If BIPI terminates this Agreement prior to the
end of the initial term or any extended term pursuant to Section 9.2,
it agrees to pay the lesser of a termination fee of [**] or the
remaining FTE reimbursement obligation for that term. No termination
fee is due if BIPI terminates the Agreement as set forth in any of
Sections 9.3 (a), 9.4 (a) or 9.6.
4.4 Milestone Payments for Designation of Qualified Lead Compounds. BIPI
agrees to make milestone payments as set forth below:
(a) [**] upon the selection by BIPI, pursuant to Section 1.1, of
each Active Compound against a designated Target. This milestone
payment will be paid for [**].
(b) [**] upon the filing of the [**] Investigational New Drug
Application (or its non-U.S. counterpart) for each Active
Compound against a designated Target. This milestone payment
will be paid for [**].
(c) [**] upon the initiation of the [**] Phase II clinical trial (or
its equivalent or non-U.S. counterpart) for each Active Compound
against a designated Target. This milestone payment will be paid
for [**].
(d) [**] upon the initiation of the [**] Phase III clinical trial
(or its equivalent or non-U.S. counterpart) for each Active
Compound against a designated Target. This milestone payment
will be paid for [**].
(e) [**] upon the filing of the [**] New Drug Application (or its
equivalent or non-U.S. counterpart) for each Active Compound
against a designated Target. This milestone payment will be paid
for [**].
(f) [**] upon the [**] approval of a New Drug Application (or its
equivalent or non-U.S. counterpart) for each Active Compound
against a designated Target. This milestone payment will be paid
for [**].
**Certain portions of this Exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
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4.5 Royalty on Net Sales of 3DP-Identified Active Compounds. BIPI agrees
to pay a royalty based on Net Sales of any BIPI Qualified Lead
Compounds and 3DP Qualified Lead Compounds that qualify as an Active
Compound and that are developed by BIPI. The royalty rate on Net Sales
of such compounds that are developed by BIPI without additional
chemical optimization by BIPI shall be negotiated by the parties in
good faith within ninety (90) days of the filing of a New Drug
Application (or its equivalent or non-U.S. counterpart) and shall be
between [**]. The royalty rate on Net Sales of such compounds that are
developed by BIPI with additional chemical optimization by BIPI shall
be negotiated by the parties in good faith within ninety (90) days of
the filing of a New Drug Application (or its equivalent or non-U.S.
counterpart) and shall be between [**].
4.6 Mode of Payment. All payments to 3DP hereunder shall be made by wire
transfer of United States Dollars in the requisite amount to such bank
account as 3DP may from time to time designate by notice to BIPI.
Payments shall be free and clear of any taxes (other than withholding
and other taxes imposed on 3DP), fees or charges, to the extent
applicable. As to the royalty payments, the amount of net sales shall
be converted into U.S. Dollars, by applying the buying rate for the
applicable day of conversion as published by Wall Street Journal on
the last business day of applicable payment period.
4.7 Records Retention. With respect to any products for which royalties
are due pursuant to Section 4.6, BIPI and its Affiliates and any
sublicensees shall keep records, for two (2) years, of such sales in
sufficient detail to confirm the accuracy of the royalty calculations
hereunder. At the request of 3DP, BIPI shall permit an independent
certified accountant appointed by 3DP, at reasonable times and upon
reasonable notice, to examine these records solely to the extent
necessary to verify such calculations. Such investigation shall be at
the expense of 3DP unless it reveals a discrepancy in BIPI's favor of
more than ten per cent (10%), in which event it shall be at BIPI's
expense.
4.8 Taxes. The Party receiving royalties and other payments under this
Agreement shall pay any and all taxes levied on account of such
payment. If any taxes are required to be withheld by the paying Party,
it shall: (a) deduct such taxes from the remitting payment, (b) timely
pay the taxes to the proper taxing authority, and (c) send proof of
payment to the other Party and certify its receipt by the taxing
authority within sixty (60) days following such payment.
5. OWNERSHIP AND LICENSE OF RIGHTS
5.1 Ownership of 3DP Accessible Libraries and 3DP Patents. 3DP shall own
all 3DP Accessible Libraries. However, in case a Qualified Lead
Compound, Active Compound or Licensed Product resulting from the
Research Program, or a method for making or using such a Qualified
Lead Compound, Active Compound or Licensed Product is covered by a
patent or patent application of 3DP based on research outside of the
Research Program, 3DP hereby grants to BIPI a fully paid up,
worldwide, exclusive license, including the right to sublicense, in
the Field under such patent to make, have made, use, sell, have sold,
import and have imported Licensed Products, provided that 3DP is not
contractually prohibited from granting such an exclusive license.
**Certain portions of this Exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
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5.2 Ownership of Custom Accessible Library Compounds. BIPI shall own
Custom Accessible Libraries and the compounds they contain that are
produced in the course of the Research Program. However, BIPI agrees
to grant 3DP a license in order to use chemical processes developed
for the synthesis of Custom Accessible Library compounds for 3DP
discovery programs. Notwithstanding the above, 3DP is not licensed to
produce Active Compounds, nor structurally related compounds to be
tested against Targets.
5.3 License to 3DP Outside of the Field. After a period of five (5) years
following the termination of the Research Program, BIPI agrees to
negotiate in good faith to grant to 3DP a license to commercialize
Qualified Lead Compounds, Active Compounds and Licensed Products
outside of the Field under any applicable Research Program Patents
owned or controlled by BIPI.
5.4 Use of Compounds After Termination of the Research Program. After a
period of five (5) years following termination of the Research
Program, BIPI agrees to grant to 3DP a fully paid up, worldwide, non-
exclusive license, including the right to sublicense, such that 3DP
shall be able to conduct research and enter into relationships with
third parties involving all compounds synthesized during and as a
result of the Research Program that are not developed or under
development by BIPI and all chemical processes developed for the
synthesis of Custom Accessible Libraries. The license grant does not
extend to BIPI patents filed after the termination of this Agreement.
5.5 License Under All 3DP Research Program Patents. Subject to the
provisions of Section 4.5, 3DP grants to BIPI a royalty-free, non-
exclusive license in the Field under all Research Program Patents
owned by 3DP to the extent such patents cover making, using, selling,
offering for sale or importing a Qualified Lead Compound, an Active
Compound or a Licensed Product.
6. CONFIDENTIAL INFORMATION
6.1 Confidentiality Obligations. The Parties agree that, for the term of
this Agreement and for ten (10) years thereafter, the "Receiving
Party" shall keep completely confidential and shall not publish or
otherwise disclose and shall not use for any purpose (except as
expressly permitted hereunder or set forth in Section 3.1 (d)) any
Confidential Information furnished to it by the "Disclosing Party"
pursuant to this Agreement (including without limitation, know-how),
except to the extent that it can be established by the Receiving Party
that such Confidential Information:
(a) was already known to the Receiving Party, other than under an
obligation of confidentiality from the Disclosing Party at the
time of disclosure;
(b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the Receiving
Party;
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(c) became generally available to the public or otherwise part of the
public domain after its disclosure and other than through any act
or omission of the Receiving Party in breach of this Agreement;
(d) was subsequently lawfully disclosed to the Receiving Party by a
third party; or
(e) disclosure was compelled by governmental administrative agency or
judicial requirements, provided, however, that the Receiving
Party shall first have given advance notice to the Disclosing
Party so as to permit the Disclosing Party to attempt to obtain a
protective order or other appropriate remedy.
6.2 Written Assurances. Each Party shall inform its employees and
consultants who perform substantial work on the Research Program, of
the obligations of confidentiality specified in Section 6.1 and all
such persons shall be bound by the terms of confidentiality set forth
therein. All employees and consultants who are inventors on any
patents arising under work carried out under the Research Program
shall assign to such Party or Parties all inventions made by such
persons during the course of performing the Research Program. Each
Party may disclose the other's Confidential Information to the extent
such disclosure is reasonably necessary in filing or prosecuting
patent applications, prosecuting or defending litigation, complying
with applicable governmental regulations, making a permitted
sublicense of its rights hereunder or otherwise in performing its
obligations or exercising its rights hereunder, provided that if a
Party is required to make any such disclosure of another Party's
secret or Confidential Information it will give at least thirty (30)
day written, advance notice to the latter Party of such disclosure
requirement and, to the extent such disclosure is not required by law,
shall provide the Party whose information is being disclosed, an
opportunity to identify Confidential Information that shall not be
disclosed.
6.3 Permitted Disclosures for Business Development Purposes.
Notwithstanding the foregoing, or any other provision in this
Agreement to the contrary, 3DP may describe the financial terms of
this Agreement in confidence, in connection with capital raising or
due diligence activities. Furthermore, BIPI acknowledges that 3DP may
be obligated to disclose terms of this Agreement and make public a
copy of this Agreement in the event it becomes a public company as
required by applicable U.S. law.
7. PATENTS AND INTELLECTUAL PROPERTY
7.1 Title to Patents. Subject to the other provisions of this Agreement,
all Research Program Patents shall be owned by BIPI, to the extent
that they claim: (a) Custom Accessible Libraries or other small
molecules synthesized by 3DP under the Research Program; (b) Qualified
Lead Compounds; (c) Active Compounds; or (d) Licensed Products. All
Research Program Patents shall be owned by 3DP to the extent that they
claim 3DP DirectedDiversity(R) Technology. All other Research
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Program Patents shall be individually or jointly owned, depending on
the relative inventive contributions of each Party.
7.2 Filing of Patent Applications and Expenses.
(a) BIPI has the right but not the obligation to pursue and maintain
Research Program Patents that it owns, at its own cost. 3DP has
the right but not the obligation to pursue and maintain Research
Program Patents that it owns, at its own cost.
(b) Where there is co-ownership of any Research Program Patents, the
Parties will decide who is in the best position to file and
pursue patent applications, and shall regularly provide each
other with copies of all filings and other material submissions
and correspondence with the patent offices, in sufficient time to
allow for review and comment. The costs of prosecuting and
maintaining patent applications that are jointly owned shall be
shared equally by the Parties.
7.3 Enforcement of Patents.
(a) If either Party considers that a Valid Claim of any of the
Research Program Patents claiming the manufacture, use or sale of
a Licensed Product is being infringed by a third party, it shall
notify the other Party and provide it with any evidence of such
infringement which is reasonably available. BIPI shall have the
right but not the obligation, at its own expense, to attempt to
remove such infringement by commercially appropriate steps,
including a lawsuit. If required by law, 3DP shall join such suit
as a party, at BIPI's expense. In the event BIPI fails to take
commercially appropriate steps with respect to such infringement
within six (6) months following notice of such infringement, 3DP
shall have the right to do so at its expense, provided that BIPI
shall not be required to enforce such Research Program Patents
against more than one entity or in more than one country at any
one time. If 3DP enforces such Research Program Patents, BIPI
agrees to join any suit as a party if required by law.
(b) Any amounts recovered by BIPI pursuant to subsection (a), above,
whether by settlement or judgment shall be reported as Net Sales
for the purpose of calculating any applicable royalties to 3DP,
after deduction of BIPI's expenses in making such recovery. Any
amounts recovered by 3DP shall be retained by 3DP.
(c) The Parties agree to discuss whatever steps may be appropriate to
enforce Research Program Patents to the extent that they
encompass the manufacture, use or sale of Active Compounds and
Licensed Products outside of the Field.
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(d) The Party not enforcing the Research Program Patents pursuant to
subsection (a), above, shall provide reasonable assistance to the
other Party, including providing access to relevant documents and
other evidence and making its employees available, subject to the
enforcing Party's reimbursement of any out-of-pocket expenses
incurred by the other Party.
(e) If either Party considers that a Valid Claim of any of the
jointly owned Research Program Patents other than those Research
Program Patents covered by subsection (a), above, is being
infringed by a third party, it shall notify the other Party and
provide it with any evidence of such infringement which is
reasonably available. The Parties agree to discuss in good faith
the enforcement of any such jointly owned Research Program
Patents. If such Patents are enforced by either Party, the Party
not enforcing such Research Program Patents shall provide
reasonable assistance to the other Party, including providing
access to relevant documents and other evidence and making its
employees available, subject to the enforcing Party's
reimbursement of any out-of-pocket expenses incurred by the other
Party.
7.4 Third Party Patent Rights. If any warning letter or other notice of
infringement is received by a Party, or action, suit or proceeding is
brought against a Party alleging infringement of a patent of any third
party in the manufacture, use or sale of an Active Compound or
Licensed Product or in the conduct of the Research Program, the
Parties shall promptly discuss and decide the best way to respond.
8. INDEMNIFICATION
8.1 Indemnification by BIPI. BIPI shall indemnify, defend and hold 3DP and
its agents, employees and directors (the "3DP Indemnitees") harmless
from and against any and all liability, damage, loss, cost or expense
(including reasonable attorneys' fees) arising out of third party
claims or suits related to (a) BIPI's performance of its obligations
under this Agreement; or (b) the manufacture, use or sale of Licensed
Products by BIPI and its Affiliates, sublicensees, distributors and
agents, except to the extent such claims or suits result from the
breach of any of the provisions of this Agreement, negligence or
willful misconduct of the 3DP Indemnitees. Upon the assertion of any
such claim or suit, the 3DP Indemnitees shall promptly notify BIPI
thereof and BIPI shall appoint counsel reasonably acceptable to the
3DP Indemnitees to represent the 3DP Indemnitees with respect to any
claim or suit for which indemnification is sought. The 3DP Indemnities
shall not settle any such claim or suit without the prior written
consent of BIPI, unless they shall have first waived their rights to
indemnification hereunder.
8.2 Indemnification By 3DP. 3DP shall indemnify, defend and hold BIPI and
its agents, employees and directors (the "BIPI Indemnitees") harmless
from and
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against any and all liability, damage, loss, cost or expense
(including reasonable attorneys' fees) arising out of third party
claims or suits related to (a) 3DP's performance to its obligations
under this Agreement or (b) the manufacture, use, or sale of Licensed
Products by 3DP and its Affiliates sublicensees, distributors and
agents except to the extent that such claims or suits result from the
breach of any of the provisions of this Agreement, negligence or
willful misconduct of the BIPI Indemnitees. Upon the assertion of any
such claim or suit, the BIPI Indemnitees shall promptly notify 3DP
thereof and 3DP shall appoint counsel reasonably acceptable to the 3DP
Indemnitees to represent the BIPI Indemnitees with respect to any
claim or suit for which indemnification is sought. The BIPI
Indemnitees shall not settle any such claim or suit without the prior
written consent of 3DP, unless they shall have first waived their
rights to indemnification hereunder.
9. TERM AND TERMINATION
9.1 Term. This Agreement shall commence upon the Effective Date. The term
of the Research Program shall be two (2) years and may be extended as
provided herein. This Agreement otherwise shall terminate upon
expiration of the last Research Program Patent owned by BIPI that
encompasses Active Compounds or Licensed Products.
9.2 Termination. BIP1 may terminate the Research Program upon thirty (30)
days advance written notice during the initial or any extended term.
However, termination fees may be due as provided in Section 4.3.
9.3 Breach
(a) Failure by a Party to comply with any of the material obligations
contained herein shall entitle the Party not in default to give
notice to have the default cured. If such default is not cured
within sixty (60) days after the receipt of such notice, or
diligent steps not taken to cure if by its nature such default
could not be cured within sixty (60) days, the Party not in
default shall be entitled, without prejudice to any of its other
rights conferred on it by this Agreement, and in addition to any
other remedies available to it by law or in equity, to terminate
this Agreement, provided, however, that such right to terminate
shall be stayed in the event that during such sixty (60) day
period, the Party alleged to have been in default shall have: (i)
initiated arbitration in accordance with Section 12.9, below,
with respect to the alleged default, and (ii) diligently and in
good faith cooperated in the prompt resolution of such
arbitration proceedings.
(b) The right of a Party to terminate this Agreement, as hereinabove
provided, shall not be affected in any way by its waiver or
failure to take action with respect to any prior default.
9.4 Insolvency or Bankruptcy.
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(a) Either Party may, in addition to any other remedies available by
law or in equity, terminate this Agreement by written notice to
the other Party in the event the latter Party shall have become
insolvent or bankrupt, or shall have an assignment for the
benefit of its creditors, or there shall have been appointed a
trustee or receiver of the other Party or for all or a
substantial part of its property or any case or proceeding shall
have been commenced or other action taken by or against the other
Party in bankruptcy or seeking reorganization, liquidation,
dissolution, winding-up, arrangement or readjustment of its debts
or any other relief under any bankruptcy, insolvency,
reorganization or other similar act or law of any jurisdiction
now or hereafter in effect, or there shall have been issued a
warrant of attachment, execution, distraint or similar process
against any substantial part of the property of the other Party,
and any such event shall have continued for ninety (90) days
undismissed, unbonded and undischarged.
(b) All rights and licenses granted under or pursuant to this
Agreement by BIPI or 3DP are, and shall otherwise be deemed to
be, for purposes of Section 365(n) of the U.S. Bankruptcy Code,
licenses of right to "Intellectual property" as defined under
Section 101 of the U.S. Bankruptcy Code. The Parties agree that
the Parties as licensees of such rights under this Agreement,
shall retain and may fully exercise all of their rights and
elections under the U.S. Bankruptcy Code. The Parties further
agree that, in the event of the commencement of a bankruptcy
proceeding by or against either Parties under the U.S. Bankruptcy
Code, the Parties hereto which is not a party to such proceeding
shall be entitled to a complete duplicate of (or complete access
to, as appropriate) any such intellectual property and all
embodiments of such intellectual property, and same, if not
already in their possession, shall be promptly delivered to them
(i) upon any such commencement of a bankruptcy proceeding upon
their written request therefor, unless the Party subject to such
proceedings elects to continue to perform all of their
obligations under this Agreement or (ii) if not delivered under
(i) above, upon the rejection of this Agreement by or on behalf
of the Party subject to such proceeding upon written request
therefor by a nonsubject Party.
9.5 Consequences of Termination. Upon termination or expiration of the
Research Program portion of this Agreement, each Party shall promptly
return all relevant records and materials in its possession or control
containing the other Party's Confidential Information and to which the
former Party does not retain rights hereunder.
9.6 Change of Control or Ownership. BIPI shall have the right to terminate
this Agreement if 3DP is acquired, merges with or otherwise combines
with a company not a party to this Agreement. Termination under this
clause does not require termination fee payments as set forth in
Section 4.3. However, before
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terminating the Agreement pursuant to this Section, BIPI shall
reasonably consider alternative steps as provided in Section 12.12.
10. REGULATORY RESPONSIBILITIES
10.1 Regulatory Approvals. BIPI shall be responsible for all regulatory
filings and related submissions that are made in connection with the
commercialization of Licensed Products and shall do at BIPI's sole
discretion and expense.
11. REPRESENTATIONS AND WARRANTIES
11.1 Authority. Each Party represents and warrants that it has the full
right, power and authority to execute, deliver and perform this
Agreement.
11.2 No Conflicts. Each Party represents and warrants that the execution,
delivery and performance of this Agreement does not conflict with, or
constitute a breach or default under any of its charter or
organizational documents, any law, order, judgment or governmental
rule or regulation applicable to it, or any material agreement,
contract, commitment or instrument to which it is a party.
11.3 No Existing Third Party Rights. The Parties represent and warrant that
their obligations under this Agreement are not encumbered by any
rights granted by either Party to any third parties.
11.4 Continuing Representations. The representations and warranties of each
Party contained in this Article 11 shall survive the execution and
delivery of this Agreement and shall remain true and correct at all
times during the term of this Agreement with the same effect as if
made on and as of such later date.
11.5 No Warranty as to Commercial Success. 3DP offers no warranty that use
of the 3DP DirectedDiversity(R) Technology under this Agreement will
result in the discovery or the successful commercialization of a
Licensed Product for use against the Target in the Field.
12. MISCELLANEOUS PROVISIONS
12.1 Accrued Rights; Surviving Obligations.
(a) Termination, relinquishment or expiration of this Agreement for
any reason shall be without prejudice to any rights which shall
have accrued to the benefit of a Party prior to such termination,
or expiration. Such termination, relinquishment or expiration
shall not relieve a Party from obligations which are expressly
indicated to survive termination or expiration of this Agreement.
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(b) Without limiting the foregoing, Sections 4.3 to 4.8 and Articles
5, 6, 7, 8 and 12 of this Agreement shall survive the expiration
or termination of this Agreement.
12.2 Further Actions. Each Party agrees to execute, acknowledge and deliver
such further instruments and to do all such other acts as may be
necessary or appropriate in order to carry out the purposes and intent
of this Agreement.
12.3 Force Majeure. The failure of a Party to perform any obligation under
this Agreement by reason of acts of God, acts of governments, riots,
wars, strikes, accidents or deficiencies in materials or
transportation or other causes of a similar magnitude beyond its
control shall not be deemed to be a breach of this Agreement.
12.4 No Trademark Rights. No right, expressed or implied, is granted by
this Agreement to a Party to use in any manner the name or any other
trade name or trademark of a Party in connection with the performance
of this Agreement.
12.5 Public Announcements. The Parties shall consult with each other and
reach mutual written agreement before making any public announcement
concerning this Agreement or the subject matter hereof. The Parties
agree to coordinate the dissemination of a joint press release to
announce the signing of this Agreement. Notwithstanding the foregoing,
the Parties may disclose the existence and general nature of this
Agreement. However, neither Party shall use the name of the other
Party for promotional purposes. BIPI shall have the right to review
all filings, to the extent that they describe the terms of this
Agreement or the arrangements with BIPI reflected herein, prior to
their submittal by 3DP to the SEC, including all proposed redacted
copies of this Agreement. 3DP shall give due respect to any reasonable
and timely request by BIPI with respect thereto, including
confidential treatment of selected portions of this Agreement.
12.6 Entire Agreement of the Parties; Amendments. This Agreement and the
exhibits hereto constitute and contain the entire understanding and
agreement of the Parties respecting the subject matter hereof and
cancels and supersedes any all prior negotiations, correspondence,
understandings and agreements between the Parties, whether oral or
written, regarding such subject matter. No waiver, modification or
amendment of any provision of this Agreement shall be valid or
effective unless made in writing and signed by a duly authorized
officer of each Party. Notwithstanding the above, the "Bilateral
Confidential Disclosure Agreement" executed on February 12, 1999 shall
remain with full force and effect.
12.7 Captions. The captions to this Agreement are for convenience only, and
are to be of no force or effect in construing or interpreting any of
the provisions of this Agreement.
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12.8 Applicable Law. This Agreement shall be governed by and interpreted
in accordance with the laws of the State of Delaware without
reference to its conflicts of law provisions.
12.9 Disputes. Either Party may give the other Party written notice of a
dispute not resolved in the normal course of business. Upon such
notice, the Parties shall attempt in good faith to resolve any
dispute arising out of or relating to this Agreement promptly by
negotiation between executives who have the authority to settle the
controversy and who are at a higher level of management than the
persons with direct responsibility for administration of this
Agreement. If the matter has not been resolved by these persons
within thirty (30) days of a disputing party's notice, either Party
may initiate mediation as provided herein. If the dispute has not
been resolved by negotiation, the Parties shall endeavor to settle
the dispute by mediation under the Center for Public Resources
("CPR") Model Procedure for Mediation of Business Disputes in effect
on the Effective Date of this Agreement. Unless the Parties agree
otherwise, a neutral mediator will be selected from a CPR Panel of
Neutrals, with the assistance of CPR or, if the Parties agree, from
the American Intellectual Property Law Association (AIPLA) Panel of
Mediators.
12.10 Notices and Deliveries. Any notice, request, delivery, approval or
consent required or permitted to be given under this Agreement shall
be in writing and shall be deemed to have been sufficiently given
when it is received, whether delivered in person, transmitted by
facsimile with contemporaneous confirmation of delivery by registered
letter (or its equivalent) or delivery by certified overnight courier
service, to the Party to which it is directed at its address shown
below or such other address as such Party shall have last given by
notice to the other Parties.
If to BIPI:
Boehringer Ingelheim Pharmaceuticals, Inc.
000 Xxxxxxxxx Xxxx
X.X. Xxx 000
Xxxxxxx, XX 00000-0000
Attention: Senior Vice President, Research & Development
with a copy to:
Attention: Vice President, General Counsel
16
If to 3DP:
3-Dimensional Pharmaceuticals, Inc.
Eagleview Corporate Center
000 Xxxxxxxx Xxxxx, Xxxxx 000
Xxxxx, XX 00000
Attention: CEO
with a copy to:
Xxxxxx, Xxxxx & Xxxxxxx LLP
0000 Xxxxxx Xxxxxx
Xxxxxxxxxxxx, XX 00000-0000
Attention: Xxxxx X. Xxxx, Esq.
12.11 No Consequential Damages. IN NO EVENT SHAI.L EITHER PARTY NOR ANY OF
ITS RESPECTIVE AFFILIATES BE LIABLE TO THE OTHER PARTY OR ANY OF ITS
AFFILIATES FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL
DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT
LIABILITY OR OTHERWISE, including, but not limited to, loss of
profits or revenue, or claims of customers of any of them or other
third parties for such or other damages.
12.12 Assignment. This Agreement may be assigned by either Party in
connection with the sale or transfer of substantially all of its
assets that relate to this Agreement. If 3DP acquires, is acquired
by, merges with or otherwise combines with a company that has
substantial activities related to Targets and is a competitor of
BIPI, BIPI may require 3DP to take reasonable actions necessary to
ensure that any of BIPI's Confidential Information, trade secrets or
proprietary information is not disclosed to personnel within such
company directly involved in such competitive activities.
12.13 Independent Contractors. Both Parties are independent contractors
under this Agreement. Nothing contained in this Agreement is intended
nor is to be construed so as to constitute 3DP or BIPI as partners or
joint ventures with respect to this Agreement. Neither Party shall
have any express or implied right or authority to assume or create
any obligations on behalf of or in the name of the other Party or to
bind the other Party to any other contract, agreement, or undertaking
with any Third Party.
12.14 Advice of Counsel. BIPI and 3DP have each consulted with counsel of
their choice regarding this Agreement, and each acknowledges and
agrees that this
17
Agreement shall not be deemed to have been drafted by one party or
another and will be construed accordingly.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their respective duly authorized officers as of the day and year first above
written, each copy of which shall for all purposes be deemed to be an original.
3 DIMENSIONAL BOEHRINGER INGELHEIM
PHARMACEUTICALS, INC. PHARMACEUTICALS, INC.
By: /s/ Xxxxx X. U'Xxxxxxxx By: /s/ Prof. Dr. Xxxxx Xxxxxxx
------------------------------------ ----------------------------------
Name: Xxxxx X. U'Xxxxxxxx, Ph.D. Name: Prof. Dr. Xxxxx Xxxxxxx
Title:CEO Title:Sr. Vice President
Research & Development
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