RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT by and between EPIX Pharmaceuticals, Inc. and Cystic Fibrosis Foundation Therapeutics, Inc.
Exhibit 10.1
Execution Copy
by and between
and
Cystic Fibrosis Foundation Therapeutics, Inc.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
Execution Copy
TABLE OF CONTENTS
Page
ARTICLE I — DEFINITIONS |
2 | |||
ARTICLE II — RESEARCH PROJECT |
14 | |||
2.1 Objective |
14 | |||
2.2 Background |
15 | |||
2.3 Duration of the Research Project |
15 | |||
2.4 Research Diligence |
15 | |||
2.4.1 Generally |
15 | |||
2.4.2 Obligations of EPIX |
16 | |||
2.5 Research Plan |
16 | |||
2.6 Joint Research Committee |
17 | |||
2.6.1 Composition and Purposes |
17 | |||
2.6.2 Meetings |
18 | |||
2.6.3 Discussions/Recommendations. |
19 | |||
2.6.4 Expenses |
19 | |||
2.7 JSC |
19 | |||
2.7.1 Composition and Purposes |
19 | |||
2.7.2 Voting and Deadlocks |
21 | |||
2.8 Development Committee |
22 | |||
2.9 Data and Material Transfer |
22 | |||
ARTICLE III
— RESEARCH FUNDING; RECORDS |
23 | |||
3.1 Research Funding |
23 | |||
3.1.1 Payments |
23 | |||
3.1.2 Limitations; Acknowledgement of Carry-Over Funding |
23 | |||
3.1.3 Budget |
24 | |||
3.1.4 Purchase of Dedicated Equipment |
26 | |||
3.1.5 Milestones |
27 | |||
3.1.6 Matched Funds |
27 | |||
3.1.7 Payments |
27 | |||
3.1.8 Competition |
27 | |||
3.2 Invoices, Records; Reporting Obligations; Audits |
29 | |||
3.2.1 Invoices |
29 | |||
3.2.2 Records |
30 | |||
3.2.3 Inspection |
30 | |||
3.2.4 Audit |
31 | |||
3.2.5 Reports; Notices |
31 |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
i
Execution Copy
Page | ||||
ARTICLE IV
— COMMERCIALIZATION; ROYALTIES |
33 | |||
4.1 Development and Commercialization of a Product |
33 | |||
4.2 Due Diligence |
33 | |||
4.3 Royalties |
33 | |||
4.4 Royalties to EPIX |
36 | |||
4.5 Royalty Stacking |
36 | |||
4.6 Sales Reports |
36 | |||
4.7 Royalty Calculations |
38 | |||
ARTICLE V — CONFIDENTIALITY — PUBLICITY |
38 | |||
5.1 Confidentiality |
38 | |||
5.1.1 Definition of Confidential Information |
38 | |||
5.1.2 Xxx-Xxxxxxxxxx |
00 | |||
5.1.3 Required Disclosure |
39 | |||
5.1.4 No Use of Confidential Information |
39 | |||
5.2 Publicity; Use of Name |
39 | |||
ARTICLE VI
— PUBLICATION |
41 | |||
ARTICLE VII
— INDEMNIFICATION |
43 | |||
7.1 Indemnification by EPIX |
43 | |||
7.2 Indemnification by CFFT |
44 | |||
7.3 Claims Procedures |
46 | |||
7.4 Participation; Assuming Control of the Defense |
46 | |||
7.5 Advance Payment of Expenses |
47 | |||
7.6 Warranty Disclaimer |
47 | |||
7.7 No Warranty of Success |
48 | |||
7.8 Limited Liability |
48 | |||
7.9 Insurance |
48 | |||
ARTICLE VIII
— PATENTABLE INVENTIONS |
49 | |||
8.1 Ownership |
49 | |||
8.2 Preparation |
50 | |||
8.3 Costs |
50 | |||
8.4 Abandonment |
50 | |||
8.5 Transfer of Alternative Compounds |
51 | |||
ARTICLE IX
— TERM AND TERMINATION |
51 | |||
9.1 Term |
51 | |||
9.2 Termination by CFFT Without Cause |
51 | |||
9.3 Termination by CFFT With Cause |
52 |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
ii
Execution Copy
Page | ||||
9.4 Termination for CFFT Breach |
52 | |||
9.5 General Effect of Termination; Survival |
53 | |||
9.6 Interruption License |
53 | |||
ARTICLE X — REPRESENTATIONS AND WARRANTIES |
55 | |||
10.1 Representations, Warranties and Covenants of EPIX |
55 | |||
10.2 Mutual Representations and Warranties |
56 | |||
ARTICLE XI
— MISCELLANEOUS PROVISIONS |
57 | |||
11.1 Governing Law |
57 | |||
11.2 Dispute Resolution |
57 | |||
11.3 Equitable Relief |
59 | |||
11.4 Waiver |
59 | |||
11.5 Force Majeure |
60 | |||
11.6 Severability |
60 | |||
11.7 Assignment |
60 | |||
11.8 Counterparts |
61 | |||
11.9 No Agency |
61 | |||
11.10 Notice |
62 | |||
11.11 Headings |
63 | |||
11.12 Entire Agreement |
63 | |||
11.13 Notice of Pharmaceutical Side-Effects |
63 | |||
11.14 Anti-Terrorist Protections. |
64 |
Exhibits
Exhibit A — Budget
|
||
Exhibit B — EDC Criteria |
||
Exhibit C — Milestone Awards |
||
Exhibit D — Research Plan |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
iii
This Agreement (as defined below) is made as of this 1st day of April, 2008 (the
“Effective Date”) by and between EPIX Pharmaceuticals, Inc. (“EPIX”), a Delaware
corporation with its principal office at 0 Xxxxxxx Xxxx, Xxxxxxxxx, XX 00000, and Cystic Fibrosis
Foundation Therapeutics, Inc., a Maryland corporation with its principal offices at 0000 Xxxxxxxxx
Xxxx, Xxxxxxxx, XX 00000 (“CFFT”), and shall become effective on the Effective Date (as
defined below). EPIX and CFFT are each a “Party,” and, collectively, the
“Parties.”
WHEREAS, CFFT’s principal charitable mission is the discovery and development of a cure for
cystic fibrosis and its complications, to which CFFT brings significant scientific and human
resources and financial support;
WHEREAS, EPIX and CFFT entered into the Agreement of March 7, 2005 (which Agreement was
subsequently amended by three subsequent amendments), which provided for Research Program I and
Research Program II. Research Program I is continued in accordance with this Agreement and,
without limitation, the Parties intend that EPIX obligation under the March 7, 2005 Agreement, as
amended, to publish the 3D structure of CFTR including its coordinates shall continue. Research
Program II has been terminated for CF, except that certain options, rights and obligations in the
March 7, 2005 Agreement and subsequent amendments survive such termination, as provided in such
agreement and subsequent amendments, including without limitation CFFT’s right to receive royalties
with respect to a P2Y2 product and certain funding obligations of CFFT as further described in
Section 3.1.2(b) below.
WHEREAS, EPIX desires to conduct the scientific research more fully described in Section 2.1
of this Agreement (the “Research Project”); and
WHEREAS, CFFT wishes to support the Research Project;
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
Execution Copy
NOW, THEREFORE, in consideration of the mutual covenants set forth in this Agreement, and for
other good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties agree as follows:
ARTICLE I — DEFINITIONS
For purposes of this Agreement, the terms defined in this Article 1 shall have the following
meanings whether used in their singular or plural forms. Use of the singular shall include the
plural and vice versa, unless the context requires otherwise:
1.1 “Affiliate” shall mean, with respect to any Person, any other Person which directly or
indirectly, by itself or through one or more intermediaries, controls, or is controlled by, or is
under direct or indirect common control with, such Person. The term “control” means the
possession, direct or indirect, of the power to direct or cause the direction of the management and
policies of a Person, whether through the ownership of voting securities, by contract or otherwise.
Control will be presumed if one Person owns, either of record or beneficially, more than fifty
percent (50%) of the voting stock of any other Person. For purposes of clarity, CFFT is an
Affiliate of the Cystic Fibrosis Foundation for purposes of this Agreement.
1.2 “Agreement” shall mean this agreement, together with all appendices, exhibits and
schedules hereto, and as the same may be amended or supplemented from time to time hereafter by a
written agreement duly executed by authorized representatives of each Party hereto.
1.3 “Applicable Law” shall have the meaning set forth in Section 10.1(b).
1.4 “Award” shall mean the amount specified in the Budget which is to be funded by CFFT.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
2
Execution Copy
1.5 “Back-Up Compound” shall mean an EDC that may replace the initial EDC in case such
replacement is necessary.
1.6 “Budget” shall mean the total budget for the costs and expenses of the Research Project
agreed upon by the Parties, which budget (a) may be amended from time to time solely upon the
mutual written agreement of the Parties, and (b) shall detail the (i) portion of such costs and
expenses to be funded by each Party; and (ii) the projected allocation and use of (A) the funds to
be paid by CFFT to EPIX for the Award; and (B) the Matched Funds. The initial Budget is attached
hereto as Exhibit A. The Budget shall include, without limitation, any Third Party costs relating
to the Research Project paid directly by CFFT at EPIX’s request.
1.7 “CFFT” shall have the meaning set forth in the preamble of this Agreement.
1.8 “CFFT Background Intellectual Property” shall have the meaning set forth in Section 8.6.
1.9 “CFFT Designee” shall have the meaning set forth in Section 2.6.1.
1.10 “CFFT Indemnitee” shall have the meaning set forth in Section 7.1.
1.11 “CFFT Patents” shall mean any Patents Controlled by CFFT or its Affiliates relating to
the Research Project.
1.12 “CFTR” shall mean a CF transmembrane conductance regulator protein which has the
biological effect of transporting molecules across human cellular membranes.
1.13 “CFTR Product” shall have the meaning set forth in Section 3.1.8.
1.14 “Change of Control Transaction” with respect to EPIX shall mean the consummation of a
transaction, whether in a single transaction or in a series of related and substantially
contemporaneous transactions, pursuant to which a Third Party[ies] none of which are stockholders
of EPIX as of the date hereof (a) acquires (whether by merger, consolidation, or
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
3
Execution Copy
transfer or issuance of capital stock or otherwise) capital stock or other equity interest of
EPIX possessing the voting power to elect a majority of the board of directors or other governing
body of EPIX (or such surviving or resulting Person) or (b) acquires assets constituting all or
substantially all of the assets of EPIX and its subsidiaries (as determined on a consolidated
basis).
1.15 “Clinical Candidate” shall mean any chemical compound that possesses the properties set
forth in Exhibit B attached hereto.
1.16 “Commercial Party” shall mean the Party under this Agreement that has the right and
license to develop and commercialize Products hereunder. As of the Effective Date and until the
grant of any Interruption License, the Commercial Party shall be EPIX and, upon the grant of an
Interruption License, if applicable, and thereafter, it shall be CFFT.
1.17 “Commercially Reasonable Efforts” shall mean the level of effort, expertise and resources
used, in the exercise of prudent business judgment, to research, develop and commercialize a
Product, where such research, development and commercialization is technically feasible, and
reasonably consistent with industry standards for similar products (for example, products that are
at a comparable stage in development), with the objective of launching such Product in North
America and the European Union as soon as commercially practicable.
1.18 “Confidential Information” shall have the meaning set forth in Section 5.1.1.
1.19 “Controlled” (except in the context of Section 1.2) shall mean the legal authority or
right of a Party hereto to grant a license or sublicense of intellectual property rights to another
Party hereto, or to otherwise disclose proprietary or trade secret information to such other Party,
without breaching the terms of any agreement with a Third Party.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
4
Execution Copy
1.20 “Cystic Fibrosis” or “CF” shall mean the human disease commonly known as cystic fibrosis.
1.21 “Dedicated Equipment” means any and all pieces of equipment, instruments or machinery,
each having an original purchase price of [********], purchased by EPIX with Award funds and used
by EPIX exclusively in the conduct of the Research Project.
1.22 “Default” shall have the meaning set forth in Section 9.3.
1.23 “Dispute” shall have the meaning set forth in Section 11.2(a).
1.24 “Dollars” shall have the meaning set forth in Section 3.1.7.
1.25 “Early Development Candidate” or “EDC” shall mean a compound that meets the criteria
defined as EDC Criteria specified in Exhibit B or which is nominated as an EDC by the JSC.
1.26 “EDC Criteria” shall mean criteria used to identify an EDC. EDC Criteria will be agreed
upon by the JSC no later than March 31, 2008 and set forth in Exhibit B and may be modified by the
JSC at any time prior to the identification of an EDC. The EDC Criteria for a Back-Up Compound may
be different than the EDC Criteria for the first EDC. The EDC Criteria for a Back-Up Compound or
for the first EDC may be modified by the JSC at any time prior to the identification of an EDC or a
Back-Up Compound.
1.27 “Effective Date” shall mean the date specified on the first page of this Agreement.
1.28 “EPIX” shall have the meaning set forth in the preamble of this Agreement.
1.29 “EPIX Background Technology” shall mean any Technology that is (a) used by EPIX, or
provided by EPIX for use in the performance of the Research Project, the development of EDCs and/or
the commercialization of Products that is Controlled by EPIX as of the Effective Date, or (b)
conceived or reduced to practice outside of the performance of the Research Project.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
5
Execution Copy
For purposes of clarity, EPIX Background Technology: (i) shall not include any technology or
rights licensed to EPIX by Tel Aviv University, including pursuant to that certain Amended and
Restated License Agreement by and between EPIX and RAMOT at Tel Aviv University dated as of May 20,
2004 (the “Tel Aviv License”), and (ii) does not include EPIX Research Project
Technology.
1.30 “EPIX Designee” shall have the meaning set forth in Section 2.6.1.
1.31 “EPIX Indemnitee” shall have the meaning set forth in Section 7.2.
1.32 “EPIX Party” shall have the meaning set forth in Section 7.1(a).
1.33 “EPIX Patents” shall mean any Patents Controlled by EPIX or its Affiliates claiming EPIX
Research Project Technology.
1.34 “EPIX Research Project Technology” shall mean all Technology conceived or reduced to
practice by EPIX or its Affiliates, in the performance of the Research Project and that is
necessary or desirable to practice the Technology utilized by EPIX in the performance of the
Research Project.
1.35 “FDA” shall mean the United States Food and Drug Administration, or any successor agency
having regulatory jurisdiction over the manufacture, distribution and sale of drugs in the United
States, and its territories and possessions.
1.36 “Field” shall mean the diagnosis, treatment and/or prevention of CF and pulmonary
diseases.
1.37 “First Commercial Sale” shall mean the first sale of a Product by EPIX or an Affiliate,
licensee, sublicensee, transferee or successor of EPIX in a country in the Territory following
Regulatory Approval of the Product in that country or, if no such Regulatory Approval
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
6
Execution Copy
or similar marketing approval is required, the date upon which a Product is first commercially
launched in that country.
1.38 “Force Majeure Event” shall have the meaning set forth in Section 11.5.
1.39 “FTE” shall mean the equivalent of the work of one EPIX scientist or other project
managerial professional, full time for one year, on or directly related to the Research Project.
Activities included in calculating FTE’s shall not include negotiation of this Agreement,
modifications or extensions thereof or administration activities such as accounting, invoicing,
personnel related activities or the like, or marketing analysis and market research.
1.40 “GAAP” shall mean U.S. generally accepted accounting principles, consistently applied.
1.41 “Hit Characterization” shall mean characterization of Hit Corrector Compound(s), Hit
Potentiator Compound(s), or Hit Dual Potentiator-Corrector Compounds, as well as related chemical
analogs that can be purchased or synthesized, to assess additional biological, ADME, and other
drug-like characteristics for such compound(s), to generate initial structure-activity
relationship(s) and for evaluation as a Lead Series or a Lead Compound. Such activities may include
biological assays, ADME assays, PK assessment, intellectual property assessment, chemical synthesis
and development of a scaffold-dependent computational model, and evaluation of other drug-like
properties as determined by EPIX. One of the goals of the Hit Characterization is the
identification of Lead Compounds along with an understanding of their properties that will need to
be optimized during lead optimization.
1.42 “Hit Corrector Compound” shall mean a compound that has an [********] or a compound that
exhibits [********] in a Corrector biological assay accepted as valid by the JSC, or such other
criteria adopted by the JSC from time to time.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
7
Execution Copy
1.43 “Hit Dual Potentiator-Corrector” shall mean a compound that can be characterized as both
a Hit Corrector Compound and as a Hit Potentiator Compound.
1.44 “Hit Potentiator Compound” shall mean a compound that has an [********] or a compound
that exhibits [********] in a Potentiator biological assay accepted as valid by the JSC, or such
other criteria adopted by the JSC from time to time.
1.45 “Interruption” shall occur if before [********], all of EPIX, its Affiliates, licensees,
sublicensees, transferees and successors, cease to use Commercially Reasonable Efforts to research,
develop and/or commercialize all EDC’s and Products in the Field for a period of [********] and
such cessation of efforts is not occasioned by a Force Majeure Event.
1.46 “Interruption License” shall have the meaning set forth in Section 9.6.
1.47 “Joint Invention” shall have the meaning set forth in Section 8.1.
1.48 “Joint Research Committee” or “JRC” shall have the meaning set forth in Section 2.6.1.
1.49 “Joint Steering Committee” or “JSC” shall have the meaning set forth in Section 2.7.1.
1.50 “Lead Compound(s)” or “Lead Series” shall mean a compound or group of compounds based on
a common scaffold of which at least one compound: (i) may be characterized as a Hit Corrector
Compound or Hit Dual Potentiator-Corrector Compound; or (ii) was characterized via Hit
Characterization activities and which has a set of drug-like properties that may be optimized
through lead optimization to an EDC or (iii) was designated as a “Lead Compound” by the JSC.
1.51 “Lead Optimization Sub-Project” shall mean a lead optimization project focused on
identification of at least one compound that meets EDC Criteria.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
8
Execution Copy
1.52 “License Income” shall mean, with respect to a Product, all consideration received by
EPIX or its Affiliates as consideration for the grant of a license to such Product(s) pursuant to
Section 4.3(c), excluding (i) payments with respect to Net Sales of a Product; (ii) payments made
by a Third Party in consideration for the issuance of equity or debt, and (iii) payments made by a
Third Party to support or fund research or development activities taken by EPIX or EPIX’
subcontractors. For purposes of clarity, if EPIX enters into such licenses for more than one
Product, the foregoing definition of Licensed Income will continue to apply to any consideration
received with respect to the license for the second and subsequent Product notwithstanding the
occurrence of the First Commercial Sale of the first Product. Amounts received after the First
Commercial Sales of a Product shall not constitute License Income if they are conditioned on events
(other than the payment date) occurring on or after the First Commercial Sale.
1.53 “Matched Funds” shall have the meaning set forth in Section 3.1.6.
1.54 “Milestone Awards” shall mean the milestone payments specified in Exhibit C.
1.55 “Milestones” shall mean the performance milestones for the Research Project established
by the Parties, as set forth in Exhibit C.
1.56 “Net Sales” with respect to any Product shall mean the gross amount invoiced by the
selling party and its Affiliates, licensees, sublicensees, transferees and/or successors for
Products sold in bona fide, arms-length transactions to Third Parties for use in the Field, less
(a) quantity and/or cash discounts from the gross invoice price which are actually allowed or
taken; (b) freight, postage and insurance included in the invoice price; (c) amounts repaid or
credited by reasons of rejections or return of goods or because of retroactive price reductions
specifically identifiable to such Product; (d) amounts payable resulting from government (or agency
thereof)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
9
Execution Copy
mandated rebate programs; (e) Third Party rebates or charge-backs to the extent actually
allowed; (f) invoiced customs duties and sales taxes (excluding income, value-added and similar
taxes), if any, actually paid and directly related to the sale that are not reimbursed by the
buyer; and (g) any other specifically identifiable amounts included in the Product’s gross invoice
price that should be credited for reasons substantially equivalent to those listed above; all as
determined in accordance with the selling Party’s usual and customary accounting methods, which are
in accordance with GAAP.
In the case of any sale or other disposal of a Product between or among the selling Party and
its Affiliates, licensees, sublicensees, transferees and/or successors, for resale, Net Sales shall
be calculated as above only on the value charged or invoiced on the first arm’s-length sale
thereafter to a Third Party.
In the case of any sale which is not invoiced or is delivered before invoice, Net Sales shall
be calculated at the time of shipment or when the Product is paid for, if paid for before shipment
or invoice.
In the case of any sale or other disposal for value, such as barter or counter-trade, of any
Product, or part thereof, other than in an arm’s length transaction exclusively for money, Net
Sales shall be calculated as above on the fair market value of the consideration received.
In the event the Product is sold (whether in a finished dosage form, in a form suitable for
cellular based therapy, or otherwise) containing the Product in combination with one or more other
active ingredients (a “Combination Product”), the Net Sales of the Product, for the
purposes of determining royalty payments, shall be determined by multiplying the Net Sales (as
defined above in this Section) of the Combination Product by the fraction, A/(A+B) where A is the
weighted (by sales volume) average sale price of the Product when sold separately in finished
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
10
Execution Copy
form and B is the weighted average sale price of the other product(s) sold separately in
finished form, provided that the formula set forth above shall not apply if the Product is only
sold in combination form and if each of the active ingredients in a Combination Product results
from the Research Project and in each such event the following sentence shall apply: In the event
that such average sale price cannot be determined for both the Product and the other product(s) in
combination, Net Sales for purposes of determining royalty payments shall be mutually agreed upon
in good faith by the Parties based on relative value contributed by each component, which such
agreement shall not be unreasonably withheld, conditioned or delayed.
1.57 “Owner” shall have the meaning set forth in Section 5.1.2.
1.58 “Party(ies)” shall have the meaning set forth in the preamble of this Agreement.
1.59 “Patents” means all existing patents and patent applications and all patent applications
hereafter filed, including any continuation, continuation-in-part, division, provisional or any
substitute applications, any patent issued with respect to any such patent applications, any
reissue, reexamination, renewal or extension (including any supplementary protection certificate)
of any such patent, and any confirmation patent or registration patent or patent of addition based
on any such patent, and all foreign counterparts of any of the foregoing.
1.60 “Person” means any individual, corporation, partnership, association, joint-stock
corporation, trust, unincorporated organization or government or political subdivision thereof.
1.61 “Phase IIa Clinical Trial” shall mean a human clinical trial intended to evaluate safety
and dosing requirements as well as the effectiveness of a product for a particular indication or
indications in patients with the disease or indication under study, as further defined in 21 CFR
§312.21(b) or any successor regulation thereto.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
11
Execution Copy
1.62 “Phase IIb Clinical Trial” shall mean a human clinical trial intended to evaluate the
effectiveness (and not only designed to assess safety or dosing requirements) of a product for a
particular indication or indications in patients with the disease or indication under study, as
further defined in 21 CFR §312.21(b) or any successor regulation thereto.
1.63 “Product” shall mean any product(s) resulting from the Research Project that contains or
is derived from an EDC or Back-Up Compound. For avoidance of doubt, “Product” shall include any
Products developed and commercialized hereunder by EPIX (directly or with or through its
sublicensees and their Affiliates) and Products developed and commercialized by CFFT (directly or
with or through its sublicensees and their Affiliates) pursuant to an Interruption License.
1.64 “Recipient” shall have the meaning set forth in Section 5.1.2.
1.65 “Recipient Notice Requirement” shall have the meaning set forth in Section 5.1.3.
1.66 “Registration” shall mean, with respect to each Product and each country in the
Territory, the Regulatory Approval for such Product filed in such country.
1.67 “Regulatory Approval” shall mean, with respect to any country, all authorizations by the
appropriate governmental entity or entities necessary for commercial sale of a Product in that
country including, without limitation and where applicable, approval of labeling, price,
reimbursement and manufacturing. “Regulatory Approval” in the United States shall mean final
approval of a new drug application or biologic license application, as the case may be, pursuant to
the then-applicable provisions of the Code of Federal Regulations permitting marketing of the
Product in interstate commerce in the United States. “Regulatory Approval” in the European Union
shall mean final approval of a Marketing Authorization Application, or equivalent, together with
price and reimbursement approval.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
12
Execution Copy
1.68 “Research Plan” shall have the meaning set forth in Section 2.5 hereof.
1.69 “Research Project” shall have the meaning set forth in Section 2.1.
1.70 “Research Termination Date” shall mean the ninth (9th) anniversary of the
Effective Date; provided that, this date may be extended by agreement of the Parties and, if EPIX
is conducting a clinical trial of an EDC of Back-Up Compound on the ninth(9th)
anniversary of the Effective Date, then the Research Termination Date shall be automatically
extended until such clinical trial is completed, except that such extension shall not be beyond the
twelfth (12th) anniversary of the Effective Date unless agreed upon by the Parties.
1.71 “Sub-Project” shall have the meaning set forth in Section 2.3.
1.72 “TDN” shall mean the Therapeutic Development Network established by CFFT.
1.73 “Technology” shall mean, collectively, inventions, discoveries, improvements, trade
secrets, know-how and proprietary methods and processes, whether or not patentable, including
without limitation: (a) methods of production or use of, and structural and functional information
pertaining to, chemical compounds and (b) compositions of matter, data, formulations, processes,
techniques, know-how and results (including without limitation any negative results).
1.74 “Tel Aviv License” shall have the meaning provided in Section 1.28.
1.75 “Territory” shall mean worldwide.
1.76 “Third Party” shall mean any Person which is not a Party or an Affiliate of any Party to
this Agreement.
1.77 “Total Anticipated Award” shall mean twenty nine million six hundred and eighty two
thousand five hundred and fifty five dollars ($29,682,555), which amount shall not include the
Milestone Awards.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
13
Execution Copy
1.78 “Valid Patent” shall mean a claim in an issued, unexpired patent within the CFFT Patents
or the EPIX Patents that (a) has not been finally cancelled, withdrawn, abandoned or rejected by
any administrative agency or other body of competent jurisdiction, (b) has not been revoked, held
invalid, or declared unpatentable or unenforceable in a decision of a court or other body of
competent jurisdiction that is unappealable or unappealed within the time allowed for appeal, (c)
has not been rendered unenforceable through disclaimer or otherwise, and (d) is not lost through an
interference proceeding.
ARTICLE II — RESEARCH PROJECT
2.1 Objective. EPIX and CFFT hereby agree to collaborate as set forth herein in the
performance of research activities aimed at identifying Early Development Candidates, and
identifying Back-Up Compounds, that are potentiators or correctors of delta508 CFTR, and developing
an EDC Compound through to completion of a Phase IIb Clinical Trial, as set forth herein (the
“Research Project”). Except as otherwise set forth herein, EPIX shall be solely
responsible for the conduct of the Research Project. CFFT shall provide the financial support
hereinafter specified, and consultation and advice as provided herein through its participation on
the JRC as provided below and shall participate in certain decision making through the JSC.
2.2 Background. Since March 2005, EPIX and CFFT have been collaborating on a project to
develop in silico models that guide the identification of CFTR corrector or potentiator compounds
for therapeutic intervention. EPIX and CFFT are interested in initiating additional discovery
activities as set forth in this Agreement. A Research Plan describing the research activities to
be conducted hereunder will be developed as provided in Section 2.5. The Research Plan will be
organized so as to progress in the following steps: (i) screening, (ii) Hit
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
14
Execution Copy
Characterization, (iii) initiation and conduct of separate Lead Optimization Sub-Projects
based on different Lead Compounds and/or Lead Series, (iv) identification of an EDC and Back-Up
Compound and (v) preclinical development and clinical development through to the completion of a
Phase IIb Clinical Trial for such EDC. These Sub-Projects shall be independent of each other, and
success/failure in one such Sub-Project may have no bearing on the success potential of the other
Lead Optimization Sub-Project. Upon discovery of an EDC and a Back-Up Compound, such compounds
will progress to preclinical development and then at least one of the EDC shall proceed to clinical
development pursuant to the Research Plan.
2.3 Duration of the Research Project. The Research Project shall commence on April 1, 2008
and shall conclude on the Research Termination Date, unless extended by mutual agreement of the
Parties, or unless earlier terminated in accordance with the provisions of Article IX hereof.
2.4 Research Diligence.
2.4.1 Generally. EPIX shall use Commercially Reasonable Efforts to: (a) conduct the Research
Project in accordance with the Research Plan and (b) satisfy and achieve the Milestones, as set
forth in Section 3.1.5 and (c) develop a Product for use in the Field. In furtherance of the
foregoing, and in accordance with the terms and conditions of this Agreement (including, without
limitation, Section 2.4.2 below), EPIX shall commit to the Research Project (directly and with and
through subcontractors): (i) an adequate number of staff, whom EPIX reasonably believes have the
necessary experience, training and scientific expertise, to enable EPIX to fulfill its obligations
hereunder, and (ii) the infrastructure (e.g., laboratories, offices, equipment and facilities)
required by the Research Plan. For avoidance of doubt, with respect to the clinical development of
a Back-Up Compound, such development may be delayed if and to
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
15
Execution Copy
the extent the JSC determines that such delay is commercially reasonable, for example if such
development would slow the development of the EDC, if no issues have arisen in the development of
the EDC that would indicate that immediate clinical development of the Back-Up Compound would be
prudent or if no evidence of meaningful differentiation between the EDC and the Back-Up Compound
emerges through development.
2.4.2 Obligations of EPIX. Subject to the terms and conditions of this Agreement, and without
limiting the generality of Section 2.4.1 above, EPIX shall be solely responsible for the conduct
and oversight of the Research Project. EPIX shall respond in a reasonably prompt and thorough
manner to all reasonable requests and inquiries from CFFT for information regarding the Research
Project during the term of this Agreement.
2.5 Research Plan. Within sixty (60) days following the Effective Date, the Parties shall
complete the Research Plan for the Research Project (the “Research Plan”). Upon
completion, the Research Plan will be attached to this Agreement as Exhibit D. The Research Plan
shall be updated each year on or before June 1st by the JRC. Each such updated Research Plan shall
be promptly provided to the JSC for approval on or before June 30th. The approved
Research Plan shall be used by the JSC, in addition to other purposes, as the basis for devising
the annual Budget for the next calendar year as described in Section 3.1.3 below. The JRC may from
time-to-time consider, review, reevaluate and discuss the Research Plan, taking into consideration
ongoing research outcomes and other scientific and commercial developments. Modifications to the
Research Plan may be proposed by any Party and shall be discussed by the JRC and recommendations
made in accordance with Section 2.6.
2.6 Joint Research Committee.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
16
Execution Copy
2.6.1 Composition and Purposes. During the term of the Research Project, a Joint Research
Committee (“JRC”) shall facilitate communication between the Parties, and make
recommendations, with respect to the Research Project. The JRC shall consist of four (4) members,
two (2) of whom shall be designated by EPIX (the “EPIX Designees”), and two (2) of whom
shall be designated by CFFT (the “CFFT Designees”). Each Party shall select a Project
Coordinator from among its designees to the JRC or may designate a Project Coordinator as an
additional non-voting member of the JRC who shall be allowed to participate in JRC meetings. Each
Party may change any such designees to the JRC at any time or from time-to-time by written notice
to the other Party. EPIX shall nominate the Chairperson of the JRC. In addition to JRC members,
CFFT and EPIX shall be entitled to bring to JRC meetings employees or advisors, provided such
advisors have executed appropriate confidential agreements. The JRC shall terminate upon the
earliest of (i) completion of the Research Project, (ii) on the Research Termination Date and
(iii) the termination of this Agreement. The JRC’s authority shall devolve from, and be
subordinate to, the authority of the JSC, and as such, shall be subject to the limitations on the
JSC’s authority as set forth in Section 2.7.1.
Without limiting the generality of the foregoing, the JRC shall:
(i) Annually review and prepare updated Research Plans and, during the year, consider, review,
and reevaluate the Research Plan, evaluate any proposed revisions to the Research Plan, and make
recommendations to the JSC regarding same, provided that amendments that would increase the Budget
must be approved by the Parties;
(ii) review reports prepared by EPIX and otherwise monitor the progress of the Research
Project and make recommendations to EPIX’ research team as needed on next steps to implement the
Research Project;
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
17
Execution Copy
(iii) gives its recommendation to the JSC on the choice of EDCs and Back-Up Compounds;
(iv) give its recommendations to the JSC on whether the Milestones have been satisfied and
achieved; and
(v) recommend to the JSC any revisions to the EDC and Clinical Development criteria set forth
in Exhibit B.
2.6.2 Meetings. The JRC shall meet no less frequently than once in each three (3) month
period during the Research Project; provided, however, that the JRC shall meet more
frequently if requested by either Project Coordinator. The first meeting of the JRC shall be held
within ninety (90) days of the Effective Date. Meetings of the JRC shall be held at such times and
locations as may be mutually agreed upon by the Project Coordinators, which times and locations
shall be communicated in writing (including, without limitation, by email) to the other members of
the JRC with reasonable advance notice of the meeting. At least one (1) EPIX Designee and one (1)
CFFT Designee shall be required to participate in a meeting for such meeting to be deemed a quorum.
So long as a quorum is present at a meeting, the JRC may take such actions as are within the scope
of the JRC’s authority hereunder. Members of the JRC may attend each meeting either in person or
by means of telephone or other telecommunications device that allows all participants to hear and
speak at such meeting simultaneously. At least ten (10) business days prior to each meeting, EPIX
shall deliver (including by email) to CFFT a written report detailing the progress made on the
Research Project since the last meeting of the JRC. Within twenty (20) days after the date of each
meeting, the EPIX Designees shall prepare and deliver (including by email) to the CFFT Designees
written minutes of such meeting setting forth in detail all discussions and/or recommendations of
the JRC made at such meeting, which
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
18
Execution Copy
minutes shall be subject to the approval and/or comment of CFFT’s Project Coordinator to be
given before the next scheduled meeting.
2.6.3 Discussions/Recommendations. The JRC shall discuss the items set forth in Section 2.6.1,
make unanimous, non-binding recommendations to the JSC as a result of such discussions, or document
any disagreements among them, and facilitate communication between the Parties with respect to the
Research Project.
2.6.4 Expenses. Each Party shall pay its own expenses (including travel and lodging expenses)
incurred in connection with the participation of its advisors on the JRC and its representatives.
2.7 JSC.
2.7.1 Composition and Purposes. EPIX and CFFT will establish a Joint Steering
Committee(“JSC”) which shall consist of an equal number of senior management personnel from
each Party with the requisite experience and seniority to enable them to make decisions on behalf
of the Parties with respect to the initiation, planning and performance of the activities of the
Research Project, as may be agreed by the Parties from time to time. The JSC shall initially have
a total of four (4) members, two (2) of whom shall be designated by EPIX and two (2) of whom shall
be designated by CFFT. The Chair of the JSC will be appointed from among the members of the JSC
designated by EPIX. The JSC shall terminate upon the earliest to occur of (i) completion of the
Research Project, (ii) on the Research Termination Date and (iii) the termination of this
Agreement. The JSC shall meet, in person or by conference telephone, semi-annually, or with such
other frequency, and at such time and location or by such means, as may be established by the JSC,
for the following purposes:
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
19
Execution Copy
(a) To provide general oversight of the Research Project and to resolve any issue referred by
the JRC as to the progress of the Research Project;
(b) To agree upon EDC Criteria, including without limitation, as relates to any Back-Up
Compound, and any subsequent revision thereof;
(c) To periodically review and agree upon the overall goals and strategy of the Research
Project;
(d) To determine whether any revision to the EDC Criteria set forth in Exhibit B and the
definition in Sections 1.42, 1.43 and 1.44 should be made;
(e) To agree on any proposed license, sublicense or transfer of EPIX Research Project
Technology provided that EPIX shall be permitted to enter into any such license or sublicense with
a Third Party that has at least the same financial and scientific resources as EPIX and that
commits to at least the same level of diligence as is required of EPIX under Section 2.4 and 4.2
hereof;
(f) To approve the clinical development plan and the Budget, and to consider and approve
revisions thereto, with the goal of devising as thorough and robust a clinical development plan as
is reasonably possible, subject to the funding obligations set forth herein;
(g) To agree upon an EDC and Back-Up Compound;
(h) To determine whether the Milestones specified in Exhibit C have been met;
(i) To determine that the Award funds and the Matched Funds were used solely for the Research
Project in accordance with the Budget;
(j) To determine whether clinical trials should be connected in association with the TDN;
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
20
Execution Copy
(k) To license from a Third Party a compound which could constitute a Hit Corrector Compound,
a Hit Potentiator Compound, or a Hit Dual Potentiator Corrector Compound; and
(l) To discuss and attempt to resolve any deadlocked issues submitted to it by the JRC.
The JSC shall have no authority to revise the terms of this Agreement or to take actions that are
inconsistent with the terms of this Agreement. The JSC shall have no authority to act on behalf of
either Party in connection with Third Parties. Without limiting the foregoing, the JSC shall have
no authority to, and shall not purport to or attempt to: (i) negotiate agreements on behalf of
either Party, (ii) make representations or warranties on behalf of either Party, (iii) waive rights
of either Party, (iv) extend credit on behalf of either Party, or (v) take or grant licenses of
intellectual property on behalf of either Party.
2.7.2 Voting and Deadlocks. EPIX members shall, collectively, have one (1) vote on the JSC,
and the CFFT members shall, collectively, have one (1) vote on the JSC. Decisions of the JSC shall
be made by unanimous vote. In the event a deadlock occurs, the JSC shall attempt to resolve such
deadlock for a period of twenty (20) days by engaging in good faith discussions. If such deadlock
is not resolved after such twenty (20) day period, then such deadlock shall be resolved in
accordance with the dispute resolution process set forth in Section 11.2, except that any dispute
requiring the amendment of this Agreement, including the Exhibits hereto shall require the
agreement of both Parties without regard to Section 11.2.
2.8 Development Committee. After the Research Termination Date, EPIX shall maintain a
development committee appropriate to the stage of development of a Product. Such
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
21
Execution Copy
committee shall meet at least semi-annually. CFFT shall be entitled to designate one member to
such committee.
2.9 Data and Material Transfer. After the completion of clinical studies of EDC’s, EPIX shall
use reasonable efforts to make available data from such studies in CF patients to the Therapeutics
Development Network (“TDN”) data bank. CFFT will remove from such data all patient
identifiers that have not been removed by EPIX in advance of allowing such access to the TDN, will
ensure the integrity and confidentiality of such information and
shall [********] the [********], in accordance with the process set forth in Article VII for any
[********] incurred by any [********] in connection with the activities described in [********] or in connection
with [********], or [********], including without limitation, for any [********]. The
TDN data bank is a central repository for data from completed TDN studies to serve as a resource of
data from CF clinical trials. EPIX shall use reasonable efforts to collect two (2) milliliters of
plasma from each CF patient enrolled in clinical trials during each blood draw and to transfer it
to the CFFT specimen bank, as and to the extent permitted by the applicable IRB, ethical
requirements and patient consents and provided that the Parties agree that such collection would
not seriously impair EPIX’ ability to successfully initiate and complete any such clinical trial.
Unless otherwise agreed by the parties, CFFT shall not perform, nor permit any Third Party to
perform, any analysis, investigation or research activities on the plasma samples provided by EPIX,
or any subgroup thereof, [********]. [********] for any incremental costs EPIX
incurs in collecting the data and materials and for making clinical data available to the TDN [********].
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
22
Execution Copy
ARTICLE III — RESEARCH FUNDING; RECORDS
3.1 Research Funding.
3.1.1 Payments. In accordance with the terms, and subject to the conditions, set forth in
this Agreement, CFFT shall make payments of the Award and the Milestone Awards, to EPIX in
accordance with Exhibits A and C attached hereto.
3.1.2 Limitations; Acknowledgement of Carry-Over Funding.
(a) Notwithstanding Section 3.1.1 above or any contrary provision contained herein, CFFT shall
not be required to make any additional payment in respect of the Award:
(i) in excess of the total amount of the then-current approved Budget; and
(ii) upon the occurrence and/or during the continuance of any Default (as defined in Section
9.3 below), including, without limitation, a Default relating to EPIX obligations under Section
3.1.6 below; provided that, amounts deferred during such Default shall become due and payable if
such Default is cured in accordance with Section 9.3; and/or
(iii) if this Agreement is terminated by any Party in accordance with Article IX; provided
that amounts that were payable as of the effective date of such termination shall remain payable.
(b) The Parties entered into that certain Research, Development and Commercialization
Agreement dated March 7, 2005 (as amended, the “2005 Agreement”), as amended by three subsequent
amendments, including the Second Amendment dated August 2, 2006 (the “Second Amendment”) and the
Third Amendment dated November 1, 2007 (the “Third Amendment”). Pursuant to the Second Amendment,
CFFT agreed to provide certain FTE
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
23
Execution Copy
funding and pursuant to the Third Amendment CFFT agreed to provide funding for specified items
of equipment. The Parties hereby acknowledge that such funding obligations shall continue in full
force and effect, in accordance with the terms of the 2005 Agreement, to enable EPIX to perform
certain activities, and to obtain certain equipment, that would be useful in enabling EPIX to
perform the Research Project hereunder. CFFT shall reimburse EPIX for such activities at the FTE
rates as provided in the 2005 Agreement for the period ending on March 31, 2008 and to purchase
equipment listed on an exhibit to the Third Amendment, all in accordance with the terms of the 2005
Agreement.
3.1.3 Budget. A quarterly Budget for the first two years of the Research Program is attached
hereto as Exhibit A. The attached Budget is agreed to and approved by the Parties. The Budget is
the Parties’ good faith estimate of the actual costs of completing the activities described in the
Research Plan, as the Research Plan is amended and updated each year. The JRC shall prepare a
draft Budget, reflecting the JRC’s good faith estimate of the actual costs of completing the
activities described in then-current Research Plan, on or before July 31st of each year,
for the next calendar year. If necessary, the JSC may extend such deadline until September
30th. The draft Budget shall then be approved by the JSC provided that the budgeted
amount, when combined with all funding previously provided hereunder by CFFT, does not exceed the
Total Anticipated Award. EPIX may at its own discretion use any budgeted amount to fund actual
Third Party costs and FTE’s related to the Research Project while shifting from one budget item to
the other, or while shifting from activities conducted in-house by internal FTE’s to outsourced
activities (except computational chemistry), provided that the total costs on a cumulative basis do
not exceed the total Budget.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
24
Execution Copy
(a) Budget Surplus. Budget surplus in any one calendar year may be used to fund any
activities within the Research Project during the following calendar year. Any such surplus
amounts shall be used to fund the first activities to be performed in the succeeding calendar year,
in accordance with the Budget, before any new amounts provided by CFFT are applied to such funding.
In addition, if, upon conclusion of the Research Project or the termination of this Agreement,
EPIX is in possession of Award funds that, when combined with previous Award amounts, exceed the
total amount of reimbursable costs and expenses hereunder as of conclusion of the Research Project,
or the effective date of termination, as applicable, then EPIX shall, within sixty (60) days
following conclusion of the Research Project, or the effective date of termination of this
Agreement, as applicable, refund such excess Award amounts to CFFT in such manner as CFFT shall
reasonably instruct EPIX.
(b) Budget Shortfall. If the total cost of performing the activities in the Research
Program exceeds the Budget for any calendar year, any Budget surplus in subsequent calendar years
shall be used to reimburse EPIX for the amount of such shortfall.
(c) Refusal to Approve Budget. Subject to the terms and conditions set forth in this
Agreement, including that the current Budget and prospective future Budgets will not exceed the
Total Anticipated Award, EPIX’ compliance with Section 3.1.3(e) below, and CFFT’s right to
terminate this Agreement without cause under Section 9.2, CFFT shall fund any Budget it approves in
accordance with this Agreement. However, CFFT may refuse to approve any Budget approved by the
JSC. In the event of such a refusal, CFFT shall be deemed to have terminated this Agreement
pursuant to Section 9.2.
(d) Excess Funding Participation Right. If neither the EDC nor a Back-Up Compound
completes a first Phase IIb Clinical Trial prior to CFFT completing funding of the
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
25
Execution Copy
Total Anticipated Award, then CFFT may, in its sole discretion, elect, by notice to EPIX no
later than one hundred and eighty (180) prior to the date on which the Parties anticipate the Total
Anticipated Award will be expended, to provide [********] of the future funding of research and
clinical development for the EDC or Back-Up Compound through to completion of the first Phase IIb
Clinical Trial and, if CFFT does provide such funding, then CFFT shall be entitled to receive
royalties on sales of Products resulting from such research and clinical development efforts at the
rates provided in Section 4.3(a) below.
(e) EPIX Covenant. EPIX hereby covenants and agrees to use the Award funds provided
by CFFT to EPIX hereunder solely to fund the Research Project in accordance with this Agreement
(including, without limitation, making applicable payments to subcontractors, vendors, consultants
and other third parties). EPIX shall repay to CFFT, within sixty (60) days of a demand by CFFT,
any Award funds that are used by EPIX to fund activities outside of the Research Project or that
are otherwise used in manner that constitutes a breach of the terms of this Agreement.
3.1.4 Purchase of Dedicated Equipment. If any portion of the Budget is used by EPIX to
purchase Dedicated Equipment and the Agreement is terminated by CFFT at any time pursuant to
Section 9.3, then, without limitation to any other damages due or owing to CFFT, within thirty (30)
days after a written request by CFFT (an “Equipment Request”), EPIX shall, at its option, either:
(a) transfer such Dedicated Equipment to any person designated by CFFT, or (b) EPIX shall purchase
such Dedicated Equipment from CFFT for an amount equal to the depreciated book value of such
equipment at the time of such Equipment Request as reflected in EPIX financial statements.
Dedicated Equipment shall be separately identified by EPIX, from time-to-time upon request of CFFT
and upon termination of the Research Project.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
26
Execution Copy
3.1.5 Milestones. CFFT shall pay to EPIX the Milestone Awards as set forth in Exhibit C upon
achievement of each such Milestone, which payments shall be non-refundable and non-creditable.
3.1.6 Matched Funds. EPIX agrees to assume responsibility for [********] of the costs of
performing certain activities in the Research Project, as specified in the Budget (EPIX share is
referred to hereinafter as “Matched Funds”).
3.1.7 Payments. All payments to be made hereunder (including, without limitation, pursuant to
Article IV) shall be made in United States dollars (“Dollars”) and, at the option and
direction of the receiving party, shall be made by check or by wire transfer of immediately
available funds. All payments shall be made without deduction for withholding or other similar
taxes to the credit of such bank account as may be designated by the receiving Party.
3.1.8 Competition. EPIX hereby agrees and acknowledges that CFFT shall be permitted to
provide funding to, or take any other action with respect to, any Person that competes with a
Product, the business, operations, and/or research of EPIX, subject to CFFT’s obligations under
Article V. Subject to the remaining terms and conditions set forth in this Section 3.1.8,
commencing on the Effective Date and until the earlier of the commercialization of a Product, or
five (5) years after the Effective Date of the Interruption License, EPIX shall not enter into any
research, development or commercialization agreement with a Third Party directed toward the
eventual commercialization (including the acquisition and sale of a marketed product) in the Field
of a pharmaceutical product that has as its principal mode of action the modulation of CFTR
(“CFTR Product”).
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
27
Execution Copy
(a) In the event of a breach of the foregoing obligation by EPIX, which breach is not cured
within the ninety (90) day cure period described in Section 9.4, CFFT shall have the right, within
thirty (30) days, either to institute an action as provided under Section 11.2 and 11.3, or to
terminate this Agreement, and to demand and receive from EPIX an Interruption License, as if EPIX
had committed an Interruption.
(b) If EPIX acquires rights to a CFTR Product, for example, by license of rights or by
acquisition of a Third Party that controls such rights, EPIX shall have a period of ninety (90)
days after such acquisition to negotiate with CFFT towards an agreement pursuant to which EPIX
would be permitted to retain both its rights hereunder and its rights to the CFTR Product, or EPIX
shall divest itself of such rights within six (6) months following the expiration of such ninety
(90) day period. EPIX shall not work on such CFTR Product during the negotiation and divestiture
process. The failure to complete such divestiture or otherwise to comply with the foregoing shall
constitute a breach by EPIX. In the event of a breach by EPIX of this Section 3.1.8, CFFT shall
have the remedies described in Section 3.1.8(a).
(c) If all or substantially all of the stock or assets (including EPIX’ rights under this
Agreement) of EPIX are acquired, directly or indirectly, by a Third Party that also controls rights
to a CFTR Product, then such acquisition shall be deemed to be a breach of this Section 3.1.8 and
the following shall apply: (i) the Third Party shall have a period of ninety (90) days after such
acquisition to negotiate with CFFT towards an agreement pursuant to which such Third Party would be
permitted to retain both its rights hereunder and its rights to the CFTR Product, or to choose
determine whether to retain or divest its rights to such CFTR Product, (ii) if such Third Party
divests itself of such rights, such divestiture shall be undertaken promptly, such Third Party
shall not continue work on such CFTR Product during the divestiture process,
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
28
Execution Copy
this Agreement shall continue in full force and effect, and the breach of this Section 3.1.8.
shall be deemed to be cured; (iii) if such Third Party retains its rights to such CFTR Product,
then CFFT shall be permitted to elect to pursue the breach damages or elect an Interruption
License, and this Agreement shall terminate; provided however, that if such breach occurs prior to
EPIX completing the [********] screen as described in the Research Plan, then, in addition to the
rights and remedies described above in Section 3.1.8(a), CFFT shall also have the right to require
that such Third Party acquirer of EPIX complete such [********] screen as described in the Research
Plan, subject to the same standards as are applicable to EPIX performance hereunder, provided that
CFFT provides the funding for such activities as provided in the then-current Research Plan and
Budget.
3.2 Invoices, Records; Reporting Obligations; Audits.
3.2.1 Invoices. EPIX shall submit invoices to CFFT within thirty (30) days after the
Effective Date and within thirty (30) days after the end of each subsequent calendar quarter.
FTE’s shall be invoiced [********] in advance of the upcoming [********] at the FTE Rate specified
in Exhibit A. External costs shall be invoiced in arrears. Such invoices shall specify amounts
in the Budget covered by the invoice. Invoices for external costs shall be accompanied by
documentation evidencing actual expenditures from the previous [********], including the identity
of FTE’s. Upon the request of CFFT, EPIX shall provide copies of interim and final reports
provided by contractors engaged in the performance of the Research Project. Each [********]
invoice for external costs shall also include a “true-up” between the actual number of FTE’s and
the number of FTE’s invoiced in advance. The invoice for [********] costs submitted by EPIX shall
be submitted not later than [********]. All invoices shall be due and payable within thirty (30)
days of receipt.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
29
Execution Copy
3.2.2 Records. EPIX shall prepare and maintain complete and accurate books and records in
connection with the Research Project (including financial records of expenditures under the Award
and the Matched Funds) and the development and commercialization of any Product, and shall keep all
such books and records for no less than a period of six (6) years from the date of such expenditure
3.2.3 Inspection. The Commercial Party shall permit the authorized representatives and agents
of the other Party, upon reasonable prior notice and at mutually agreed times, to confer with the
Commercial Party’s personnel for the purpose of verifying the Commercial Party’s compliance with
the terms and conditions of this Agreement and, in the case of CFFT, for the purpose of discussing
with EPIX personnel the progress and results of the Research Project. In addition, the Commercial
Party’s personnel shall be available to discuss (whether in person or via telephone) with the
other Party the books and records and/or reports delivered by the Commercial Party to the other
Party at such time or times as the other Party may reasonably request. At the request of the other
Party, the Commercial Party shall use reasonable efforts to facilitate a meeting or correspondence
between the other Party and any licensees, sublicensees and subcontractors of the Commercial Party.
3.2.4 Audit. At the request of the other Party, from time to time, the Commercial Party shall
permit the other Party internal accounting personnel or representatives and agents of an
independent, certified public accounting firm appointed by the other Party, upon reasonable notice
and at mutually agreed times, but not more often than once a year, to audit and examine such books
and records of the Commercial Party and any sublicensees of any of the rights granted to the
Commercial Party hereunder as may be necessary for verifying the Commercial Party’s payment of
amounts due hereunder and, in the case of CFFT, to verify that
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
30
Execution Copy
expenditures of the Award and the Matched Funds have been in conformity with this Agreement.
The records from any given period shall be subject to audit only one time. Any and all records
audited and examined by the other Party personnel or such representatives and agents of such
accounting firm shall be deemed the Commercial Party’s Confidential Information. The other Party
shall pay the reasonable costs of such audit and examination of the books and records of the
Commercial Party, provided however, that if such audit and examination reveals a
discrepancy of more than [********] of the expenditures between the amounts reported by the
Commercial Party to the other Party hereunder and the amounts actually due and payable hereunder
for the period under audit, or in the case of CFFT, between the amount of the Award or Matched
Funds actually due hereunder for the period under audit, then the Commercial Party shall reimburse
the other Party for all costs and expenses incurred by the other Party in connection with such
audit and examination.
3.2.5 Reports; Notices. The Commercial Party shall (a) maintain a system of accounting in
accordance with GAAP, (b) keep full and complete financial records and maintain an effective system
of internal controls, and (c) furnish to the other Party reports and/or notices as follows:
(a) Within a reasonable period of time after the Research Termination Date, EPIX shall provide
to CFFT a closing report reasonably satisfactory to CFFT and which shall (i) be prepared by EPIX or
an EPIX-approved Third Party, and (ii) shall set forth EPIX’ final analysis, summary tables, data
listings, results and conclusions from the Research Project and such other information and
materials as CFFT may reasonably request.
(b) EPIX, and in the case an Interruption License is granted, CFFT, shall, within [********]
after such Party’s annual audit report is finalized, provide to the other Party
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
31
Execution Copy
audited financial statements as of the end of such year (including without limitation, a copy
of the consolidated balance sheet of such Party as of the end of such year, together with
consolidated statements of income, operations, cash flow and retained earnings of such Party for
such year), prepared in accordance with GAAP, along with comparative financial statements of the
prior year; provided that if such Party makes such records generally available, for example by
posting on its website or filing with the Securities and Exchange Commission, the requirements of
this Section 3.2.5(b) shall be satisfied thereby.
(c) The Commercial Party shall provide to the other Party, as soon as practicable, but in any
case no less than [********] in advance, written notice of any proposed license, sublicense or
transfer of the right to develop or commercialize a Product.
(d) As soon as practicable, and in any event promptly after the commencement thereof, notice
of all material actions, suits, claims, proceedings, investigations or any other event that could
materially impact the Party’s ability to perform its obligations hereunder.
(e) As soon as practicable, and in any event within [********] after January 1 and June 1 of
each calendar year following the Research Termination Date, progress reports and status updates on
the Commercial Party’s activities with respect to the Research Project, including, without
limitation, the continuing development and/or commercialization of any Products, the Commercial
Party’s compliance with the terms of this Agreement, and any other information that the other Party
reasonably requests.
ARTICLE IV — COMMERCIALIZATION; ROYALTIES
4.1 Development and Commercialization of a Product. Following the completion of the work set
forth in the Research Plan relating to the Research Project, EPIX shall, at its own
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
32
Execution Copy
expense, use Commercially Reasonable Efforts to develop, commercialize and bring at least one
(1) Product in the Field identified in the Research Project to market. In connection therewith,
EPIX shall use Commercially Reasonable Efforts: (i) to conduct all additional clinical trials
required for Regulatory Approval, (ii) to file all required Registrations, (iii) to conduct any
required post-marketing clinical studies, and (iii) to take all necessary or advisable actions in
connection with the manufacturing, marketing, promotion, sales and distribution of a Product in the
Field.
4.2 Due Diligence. EPIX shall use Commercially Reasonable Efforts to effect introduction of
Products in North America and the European Union.
4.3 Royalties.
(a) In consideration of CFFT’s payments to EPIX and CFFT’s licenses to EPIX hereunder (and
except as provided in subparagraph (b) of this Section 4.3), EPIX shall pay to CFFT the following
royalties on the following segments of aggregate [********] Net Sales of Product[s]:
(i) [********] Net Sales up to [********];
(ii) [********] Net Sales in excess of [********]; and
(iii) [********] Net Sales in excess of [********].
(b) In the event that CFFT terminates its financial support of the Research Project pursuant
to Section 9.2 prior to funding the Total Anticipated Award, or EPIX terminates the Research
Project pursuant to Section 9.4, the royalties specified in subparagraph (a) of this Section 4.3
shall not be applicable and instead EPIX shall pay CFFT the following royalty on [********] Net
Sales of each Product:
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
33
Execution Copy
(i) If termination is prior to the [********] anniversary of the Effective Date: [********];
and
(ii) If termination occurs after the [********] anniversary of the Effective Date and prior to
the [********] anniversary of the Effective Date, [********]; and
(iii) If termination occurs after the [********] anniversary of the Effective Date and prior
to the [********], [********].
(c) In the event that CFFT terminates its financial support of the Research Project pursuant
to Section 9.2 after having funded the Total Anticipated Award, but prior to the completion of the
first Phase IIa Clinical Trial with the first EDC or Back-Up Compound, then the royalties specified
in subparagraphs (a) and (b) of this Section 4.3 shall not be applicable and instead EPIX shall pay
CFFT a royalty of [********] Net Sales of each Product.
(d) In the event that CFFT terminates its financial support of the Research Project pursuant
to Section 9.2 after having funded the Total Anticipated Award, and after the completion of the
first Phase IIa Clinical Trial with the lead Product under development at the time of such
termination, then the royalties specified in subparagraphs (a), (b) and (c) of this Section 4.3
shall not be applicable and instead EPIX shall pay CFFT the following royalties on the following
segments of aggregate [********] Net Sales of Product[s]:
(i) [********] Net Sales up to [********];
(ii) [********] Net Sales in excess of [********]; and
(iii) [********] Net Sales in excess of [********].
(e) In addition to the royalties specified in subparagraphs (a), (b), (c) and (d) of this
Section 4.3, EPIX shall pay CFFT (i) [********] of any License Income for which EPIX or its
Affiliates have the right unconditionally prior to the first dosing of CF patients; and (ii)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
34
Execution Copy
[********] of any License Income as to which EPIX’s rights remain subject to conditions that
are not satisfied until after such first dosing.
(f) In the event that CFFT terminates its financial support of the Research Project pursuant
to Section 9.2 or EPIX terminates the Research Project pursuant to Section 9.4, the License Income
specified in subparagraph (c) of this Section 4.3 shall not be applicable and instead EPIX shall
pay CFFT the following percentage of License Income:
(i) If termination is prior to the end of [********] after the Effective Date: [********]; and
(ii) If termination occurs after the end of [********] after the Effective Date but prior to
[********] then EPIX shall pay CFFT (i) [********] of any License Income EPIX or its Affiliates
receive prior to the first dosing of CF patients; and (ii) [********] of any License Income EPIX or
its Affiliates receive after such first dosing.
4.4 Royalties to EPIX. Pursuant to Section 9.6, in the event that the Interruption License
becomes effective, in lieu of any other royalties pursuant to this Agreement (other than royalties
or payments under Section 4.3 previously paid or due by EPIX to CFFT in accordance with this
Agreement), CFFT shall pay to EPIX [********] of any amount CFFT receives with respect to EPIX
Research Project Technology (including Product sales), including without limitation, amounts CFFT
receives in connection with sublicenses of an Interruption License; provided however, that no
amount shall be due and payable by CFFT to EPIX pursuant to this Section 4.4 until CFFT has
recovered the aggregate amount of the Award funded by CFFT plus Milestone Awards, provided that, if
CFFT’s Interruption License is activated prior to the [********] anniversary of the Effective Date
as a result of EPIX’s breach of this Agreement, the [********] royalty specified above shall be
[********].
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Exchange Act; [*] denotes omissions.
35
Execution Copy
4.5 Royalty Stacking. In the event that either Party is at any time required to make payments
to one or more Third Parties in order to make, use or sell Products, such Party may deduct
[********] of any such Third Party payments made by such Party from any payments thereafter payable
to the other Party, provided that in no event shall the amounts otherwise payable to such Party be
reduced by more than [********].
4.6 Sales Reports.
4.6.1 Within [********] following Regulatory Approval of a Product and each [********] period
thereafter, the Commercial Party shall furnish or cause to be furnished to the other Party a
written report or reports covering the relevant period setting forth in detail the Net Sales during
such period. With respect to sales of Products invoiced in Dollars, the Net Sales amounts and the
amounts due to the other Party hereunder shall be expressed in Dollars. With respect to sales of
Products invoiced in a currency other than Dollars, the Net Sales and amounts due to the other
Party hereunder shall be expressed in the domestic currency of the party making the sale, together
with the Dollar equivalent of the amount payable to the other Party, calculated by translating
foreign currency sales into Dollars at the exchange rates for the [********] as reported in The
Wall Street Journal, Eastern US Edition. If any licensee or sublicensee makes any sales invoiced
in a currency other than its domestic currency, the Net Sales shall be converted to its domestic
currency in accordance with the licensee’s or sublicensee’s normal accounting principles. The
Commercial Party shall also promptly report the receipt of any other income received by it during
such period attributable to Products, including proceeds received in connection with the grant or
performance of a sublicense of any rights granted hereunder. The Commercial Party shall keep
accurate records in sufficient detail to enable the amounts due
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
36
Execution Copy
hereunder to be determined and to be verified by the other Party in accordance with Section
3.2.4.
4.6.2 In case of any delay in payment by the Commercial Party to the other Party not
occasioned by a Force Majeure Event in accordance with Section 11.5, interest shall accrue at the
[********] from the due date until paid in full; provided that, in no event shall said annual rate
exceed the maximum interest rate permitted by law in regard to such payments. Any such overdue
royalty payment shall, when made, be accompanied by, and credited first to, all interest so
accrued.
4.7 Royalty Calculations. Royalties shall be payable hereunder only on Products, the
manufacture, use, sale or importation of which in or into a specified country is covered by a Valid
Claim. Royalties shall be determined on a [********] basis.
ARTICLE V — CONFIDENTIALITY — PUBLICITY
5.1 Confidentiality.
5.1.1 Definition of Confidential Information. For purposes of this Agreement,
“Confidential Information” shall mean: (a) the material business terms of this Agreement;
and (b) any trade secrets, confidential or proprietary information, or any other knowledge,
information, documents or materials, owned, developed or possessed by Owner (as defined below),
whether in tangible or intangible form, the confidentiality of which Owner takes reasonable
measures to protect. “Confidential Information” shall not, however, include any
information of Owner specified in subparagraph (b) above that: (i) is already known to Recipient
(as defined below) at the time of its disclosure as evidenced by Recipient’s written records; (ii)
becomes publicly known through no wrongful act of Recipient; (iii) is received from a Third
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
37
Execution Copy
Party whom Recipient reasonably believes is free to disclose it to Recipient and without any
obligations to Owner to keep such information confidential; or (iv) is independently developed by
Recipient without using any Confidential Information of the Owner as evidenced by Recipient’s
written records.
5.1.2 Non-Disclosure. Commencing with the date on which the Confidential Information is
disclosed and for a period of five (5) years thereafter, each Party (“Recipient”) shall
hold all Confidential Information it receives or received from the other Party (“Owner”) in
strict confidence and, without first obtaining the prior written consent of Owner, shall not
disclose any Confidential Information to any Person, except to directors, officers, employees,
consultants, committee members, volunteers, contractors, subcontractors, licensees, sublicensees,
accountants or counsel of Recipient who have (a) a need to know such Confidential Information, (b)
agreed in writing to be bound by Recipient’s obligations under this Agreement and (c) been informed
of the confidential nature of the Confidential Information. Recipient shall use the same degree of
care to avoid the disclosure of such Confidential Information as it uses with respect to its own
confidential information.
5.1.3 Required Disclosure. Notwithstanding Section 5.1.2 above, Recipient’s disclosure of
Confidential Information shall not be prohibited if such disclosure is required by a legally
binding requirement; provided, however, that, Recipient shall have first given
prompt notice to Owner of any possible requirement and Owner shall have been afforded a reasonable
opportunity to prevent or limit such disclosure (the “Recipient Notice Requirement”);
provided, further, that the Recipient Notice Requirement shall not apply to
proceedings which, by Applicable Law, are of a nature that the existence of such proceedings may
not be disclosed or made public. In the event that Recipient discloses any Confidential
Information pursuant to the
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
38
Execution Copy
immediately preceding sentence, Recipient shall cooperate with Owner, at Owner’s sole cost and
expense, in the prosecution of any appeal that Owner decides to pursue.
5.1.4 No Use of Confidential Information. Unless otherwise agreed to in writing by the Owner,
Recipient shall only use the Owner’s Confidential Information in accordance with the terms of this
Agreement.
5.2 Publicity; Use of Name.
5.2.1 The Parties shall mutually agree upon the timing and content of any initial press
release or other public announcement relating to this Agreement and the transactions contemplated
herein.
5.2.2 Except to the extent already disclosed in the initial press release or other public
announcement referenced in Section 5.2.1 above, and except as may be otherwise provided herein,
neither Party shall issue any press release or make any public announcement concerning the terms of
this Agreement or the transactions described herein without the prior written consent of the other
Party, which such consent shall not be unreasonably withheld, conditioned or delayed;
provided, however, that it shall not be unreasonable for any Party to withhold
consent with respect to any press release or public announcement containing any of such Party’s
Confidential Information; and, provided, further, that this Article V shall not
preclude any Party from issuing any such press release or making any such public announcement if
such Party reasonably believes that any such release or announcement is (a) legally required by
Applicable Law, or (b) required by the rules of any stock exchange on which such Party’s securities
are listed. Notwithstanding the foregoing, EPIX shall be permitted to disclose the existence and
terms of this Agreement to investment bankers, investors, and potential investors,
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
39
Execution Copy
licensees and potential licensees, acquirers or merger partners, lenders and potential lenders
and potential acquirers or merger partners who have executed a confidentiality agreement with EPIX.
5.2.3 In each instance, the Party desiring to issue any press release or to make any public
announcement shall provide the other Party with a written copy of the proposed release or
announcement in sufficient time prior to public release to allow such other Party to comment upon
such release or announcement prior to its public release. In addition, each press release and/or
public announcement issued or made pursuant to this Section 5.2 shall include CFFT-approved
language acknowledging CFFT’s contribution to the funding of the Research Project.
5.2.4 Except as may be otherwise provided herein, no Party shall have any right, express or
implied, to use in any manner the name or other designation of the other Party or any other trade
name, trademark or logos of the other Party for any purpose.
5.2.5 Notwithstanding the foregoing or any contrary provision contained herein, in connection
with: (a) any description by either Party of its research portfolio and of its industry discovery
and development program, and/or (b) such Party’s fundraising activities, marketing materials and/or
reporting requirements, such Party shall be entitled to use and/or disclose, and the other Party
hereby pre-approves such Party’s use and/or disclosure of: (i) the names of the other Party, the
other Party’s logo and a general description of the other Party, (ii) the existence and a general
description of the nature of this Agreement, and (iii) a general description of the nature of the
Research Project.
ARTICLE VI — PUBLICATION
6.1 Publication. Each of EPIX and CFFT reserves the right to publish or publicly present the
data generated during the performance of, or as a result of, the Research Project (the
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
40
Execution Copy
“Results”), subject to the following terms and conditions. The Party proposing to
publish or publicly present the Results (the “publishing party”) will submit a draft of any
proposed manuscript or speech to the other Party (the “non-publishing party”) for comments
at least sixty (60) days prior to submission for publication or oral presentation. The
non-publishing party shall notify the publishing party in writing within thirty (30) days of
receipt of such draft whether such draft contains (a) information of the non-publishing party which
it considers to be Confidential Information under the provisions of Article V hereof, (b)
information that if published would have an adverse effect on a patent application which the
non-publishing party intends to file, or (c) information which the non-publishing party reasonably
believes would be likely to have a material adverse impact on the development or commercialization
of a Product. In any such notification, the non-publishing party shall indicate with specificity
its suggestions regarding the manner and degree to which the publishing party may disclose such
information. In the case of item (a) above, no Party shall publish the Confidential Information of
the other Party without the prior written consent of such other Party in violation of Article V of
this Agreement. In the case of item (b) above, the non-publishing party may request a delay and
the publishing party shall delay such publication, for a period not exceeding an additional ninety
(90) days, to permit the timely preparation and filing of a patent application or an application
for a certificate of invention on the information involved. In the case of item (c) above, if the
publishing party shall disagree with the non-publishing party’s assessment of the impact of the
publication, then the issue shall be referred to the JSC. In no event, however, shall any
publication be made by CFFT without EPIX’ consent. The Parties agree that authorship of any
publication will be determined based on the customary standards then being applied in the relevant
scientific journal and that
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
41
Execution Copy
JRC members and consultants may be designated as authors if it is appropriate under the
circumstances.
Notwithstanding the foregoing, (a) EPIX intends to advance the body of general scientific
knowledge of cystic fibrosis and its potential therapies and cures, all in a manner consistent with
its general scientific and commercial objectives in entering into the collaboration with CFFT to
which this Agreement relates, (b) EPIX shall after the Effective Date publish the 3D structure of
in accordance with the March 7, 2005 agreement between the Parties, and (c) EPIX intends to publish
the results of the Research Project in a major scientific peer-reviewed. EPIX shall acknowledge
the financial support of CFFT in all publications referencing the Research Project.
In furtherance of the foregoing, EPIX may, in its sole discretion, make available to academic
Third Parties for non-commercial research purposes tangible research materials or resources
developed during the Research Project, excluding, without limitation, EDCs, Back Up Compounds, and
Clinical Candidates. Such materials and resources shall be provided, if at all, on an “at cost”
basis, that may be waived at EPIX discretion, pursuant to the terms of material transfer agreements
between EPIX and the academic Third Parties, which agreements shall contain customary terms and
conditions.
ARTICLE VII — INDEMNIFICATION
7.1 Indemnification by EPIX. EPIX shall indemnify, defend and hold harmless CFFT, its
Affiliates, and their respective directors, officers, employees, consultants, committee members,
volunteers, agents and representatives and their respective successors, heirs and assigns
(including, without limitation, the CFFT Designees) (each, a “CFFT Indemnitee”), from and
against any and all claims, suits and demands of Third Parties and losses, liabilities, damages for
personal injury, property damage or otherwise, costs, penalties, fines and expenses (including
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
42
Execution Copy
court costs and the reasonable fees of attorneys and other professionals) of any Third Party
to the extent arising out of, resulting from and relating to:
(a) the conduct of: (i) the Research Project by EPIX or its Affiliates or their respective
directors, officers, employees, consultants, agents, representatives, licensees, sublicensees,
subcontractors and/or investigators, but excluding all CFFT Indemnitees (each, an “EPIX
Party”) under this Agreement, or any actual or alleged violation of law resulting therefrom; or
(ii) EPIX and its Affiliates business or operations outside of the Research Project;
(b) an EDC or Product developed and/or commercialized by EPIX, its Affiliates or their
sublicensees as a result of the Research Project (but excluding any EDC or Product developed or
commercialized by CFFT, its Affiliates or their sublicensees under an Interruption License
regardless of EPIX prior participation in any such development or commercialization activities);
(c) any claim of infringement or misappropriation of intellectual property with respect to the
performance by EPIX or any EPIX Party of the Research Project or any Product developed in whole or
in part as a result of the Research Project (but excluding any such claims as relating to: (i) a
Product developed or commercialized by CFFT, its Affiliates or their sublicensees under an
Interruption License regardless of EPIX prior participation in any such development or
commercialization activities or (ii) the practice of any CFFT Background Technology);
(d) EPIX’ breach of any of its representations, warranties, covenants and/or material
obligations under this Agreement, or the negligence or willful misconduct of any EPIX Party in
connection with EPIX’ performance of its obligations under this Agreement; or
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
43
Execution Copy
(e) any tort claims of personal injury (including death) relating to or arising out of any
such injury sustained as the result of, or in connection with, the Research Project or any Product
developed in whole or in part as a result of the Research Project (but excluding any such claims as
relating to an EDC or Product developed or commercialized by CFFT, its Affiliates or their
sublicensees under an Interruption License regardless of EPIX prior participation in any such
development or commercialization activities).
7.2 Indemnification by CFFT. CFFT shall indemnify, defend and hold harmless EPIX, its
Affiliates, and their respective directors, officers, employees, consultants, committee members,
volunteers, agents and representatives and their respective successors, heirs and assigns (each, a
“EPIX Indemnitee”), from and against any and all claims, suits and demands of Third Parties
and losses, liabilities, damages for personal injury, property damage or otherwise, costs,
penalties, fines and expenses (including court costs and the reasonable fees of attorneys and other
professionals) of any Third Party to the extent arising out of, resulting from and relating to:
(a) the conduct of: (i) research, development and commercialization activities by CFFT or its
Affiliates or their respective directors, officers, employees, consultants, agents,
representatives, licensees, sublicensees, subcontractors and/or investigators, but excluding all
EPIX Indemnitees (each, a “CFFT Party”) of a Product under an Interruption License and/or
pursuant to one or more agreements between CFFT and any CFFT Party, or any actual or alleged
violation of law resulting therefrom; or (ii) CFFT and its Affiliates’ business or operations
outside of this Agreement;
(b) an EDC or Product developed and/or commercialized by CFFT, or its Affiliates or their
representatives, agents, authorized licensees, sublicensees or subcontractors, in
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
44
Execution Copy
whole or in part under an Interruption License (regardless of EPIX prior participation in any
such development or commercialization activities with respect to such EDC or Product);
(c) CFFT’s breach of any of its representations, warranties, covenants and/or material
obligations under this Agreement, or the negligence or willful misconduct of any CFFT Party in
connection with CFFT’s performance of its obligations under this Agreement.
(d) any claim of infringement or misappropriation of intellectual property with respect to the
development or commercialization of any EDC or Product under an Interruption License; or
(e) any tort claims of personal injury (including death) relating to or arising out of any
such injury sustained as the result of, or in connection with, the development or commercialization
of any EDC or Product under an Interruption License (regardless of EPIX prior participation in any
such development or commercialization activities).
7.3 Claims Procedures. Promptly after receipt by a person seeking recovery under Sections 7.1
or 7.2 (an “Indemnified Party”) of notice of the commencement of any action, suit or
proceeding, such Indemnified Party shall, if a claim for indemnification in respect thereof is to
be made against the Party from which indemnification is sought (the “Indemnifying Party”),
deliver to the Indemnifying Party written notice of the commencement thereof, and, subject to
Section 7.4, Indemnifying Party shall have the right to assume and manage the defense thereof (with
counsel reasonably satisfactory to Indemnifying Party and such Indemnified Party), including the
right to settle, compromise and/or litigate with respect to any such claim (but only after
obtaining Indemnified Party’s prior written consent with respect to any proposed settlement,
compromise or litigation; provided, however, that Indemnifying Party shall not be required to
obtain Indemnified Party’s prior written consent in connection with any proposed
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
45
Execution Copy
settlement, compromise or litigation if, in connection with and following any such settlement,
compromise or litigation, Indemnified Party (a) has no liability (monetary or otherwise), (b) has
not waived any of its rights and has not admitted to any wrongdoing or guilt, (c) is not subject to
any injunction or other equitable or non-monetary relief, and (d) receives a full and unconditional
release of all applicable claims and liability.
7.4 Participation; Assuming Control of the Defense. Notwithstanding Section 7.3 above, the
Indemnified Party may participate in the defense of any claim at such Indemnified Party’s sole
expense, with counsel reasonably acceptable to the Indemnifying Party; provided,
however, if (a) there is a conflict of interest that would prevent the Indemnifying Party,
on the one hand, and the Indemnified Party, on the other hand, from being represented by a single
law firm in the defense of such action; in each such instance, or (b) there shall be one or more
additional or other defenses available to the Indemnified Party that are not available to the
Indemnifying Party, then in each such instance Indemnifying Party shall pay the reasonable fees and
expenses of one law firm serving as counsel for the Indemnified Party, as applicable, which law
firm shall be subject to the prior consent of the Indemnifying Party, which consent shall not be
unreasonably withheld, conditioned or delayed.
7.5 Advance Payment of Expenses. The expenses of an Indemnitee incurred in defending a civil
or criminal action, suit or proceeding under Sections 7.1 or 7.2 above shall be paid by the
Indemnifying Party as they are incurred and in advance of the final disposition of the action, suit
or proceeding, upon receipt of an undertaking by or on behalf of the Indemnitee to repay the amount
if it is ultimately determined by a court of competent jurisdiction that such Indemnitee is not
entitled to be indemnified by the Indemnifying Party. All costs and expenses
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
46
Execution Copy
incurred by an Indemnitee in connection with enforcement of this Article VII also shall be
reimbursed by the Indemnifying Party.
7.6 Warranty Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER
PARTY MAKES ANY WARRANTY WITH RESPECT TO ANY TECHNOLOGY, GOODS, SERVICES, RIGHTS OR OTHER SUBJECT
MATTER OF THIS AGREEMENT, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY OR OF
FITNESS FOR A PARTICULAR PURPOSE OR NON-VIOLATION OF THIRD PARTY PROPRIETARY RIGHTS. IN ADDITION,
NEITHER PARTY MAKES ANY WARRANTIES AS TO THE VALIDITY OR ENFORCEABILITY OF THE PATENT RIGHTS
LICENSED BY SUCH PARTY TO THE OTHER PARTY.
7.7 No Warranty of Success. Nothing contained in this Agreement shall be construed as a
warranty on the part of either Party that (a) the Research Project will yield any Product or
otherwise be successful or (b) the outcome of the Research Project or any subsequent development
program will be commercially exploitable in any respect.
7.8 Limited Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR ANY OF ITS
AFFILIATES UNDER OR IN CONNECTION WITH THIS AGREEMENT FOR ANY SPECIAL, PUNITIVE, INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION LOST PROFITS OR LOST REVENUES,
WHETHER UNDER ANY CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE
THEORY. This Section 7.8 is not intended to limit either Party’s obligations or rights under
Sections 7.1 or 7.2.
7.9 Insurance. At such time as a Party becomes the Commercial Party with respect to a
Product, such Party shall maintain at its own expense, with a reputable insurance carrier
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
47
Execution Copy
reasonably acceptable to the other Party, coverage for such Party, its Affiliates, and their
respective employees written on a per occurrence basis commensurate with a reasonable assessment of
the risks associated with the research efforts being conducted by the Commercial Party, which
insurance will name the other Party as an additional insured, including, without limitation, errors
and omissions insurance encompassing claims relating to the performance and lack of performance of
the Commercial Party’s obligations under this Agreement and comprehensive general liability
insurance for claims relating to the performance and lack of performance of the Commercial Party’s
obligations under this Agreement and comprehensive general liability insurance for claims for
damages arising from bodily injury (including death) and property damages arising out of acts or
omissions of the Commercial Party, and its Affiliates or their respective directors, officers,
employees, consultants, agents, representatives, licensees, sublicensees, subcontractors and/or
investigators. Maintenance of such insurance coverage will not relieve the Commercial Party of any
responsibility under this Agreement for damage in excess of insurance limits or otherwise. On or
prior to the time when a Party becomes the Commercial Party with respect to a Product, such Party
shall provide the other Party with an insurance certificate from the insurer(s) evidencing each
insurance coverage and the insurer’s agreement to notify such other Party at least sixty (60) days
in advance of any cancellation or modification of such insurance coverage. At its request, such
other Party may review the Commercial Party’s insurance coverage with relevant officials of the
Commercial Party from time to time.
ARTICLE VIII — PATENTABLE INVENTIONS
8.1 Ownership. All Technology conceived or reduced to practice and all data and know-how
generated exclusively by either Party or its Affiliates (directly or through others
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
48
Execution Copy
acting on its behalf) prior to and during the term of this Agreement relating to the Research
Project shall be owned by the Party making the invention or generating the data or know how
claimed, or if such invention is made jointly by the Parties (a “Joint Invention”), shall
be owned jointly, all as determined in accordance with United States laws of inventorship;
provided, however, that CFFT hereby grants to EPIX [********] and [********] made by any CFFT employee
resulting from the Research Project [********].
8.2 Preparation. EPIX shall take responsibility at its own expense for the preparation,
filing, prosecution and maintenance of all EPIX Patents, and any Patents with respect Joint
Inventions, and CFFT take responsibility for the preparation, filing, prosecution and maintenance
of all CFFT Patents, if any. Each Party shall have the right to review all such patent
applications prior to their filing and the filing party shall make copies of such patent
applications available for such review. Each Party shall provide the JSC with periodic reports
listing, by name, Patents filed by such Party in the United States and other jurisdictions relating
to the Research Project, along with a general summary of the claims made and the jurisdictions of
filing.
8.3 Costs. Each Party shall bear its own internal costs in regard to the activities described
in the above Section 8.2, provided that [********] of the filing fees, counsel fees, translation
costs and the like shall be included in the Budget until such time as the first EDC or Back-Up
Compound enters clinical testing and [********] of such amounts shall be included in the Budget
thereafter, provided that in each case, CFFT’s contribution to funding such amounts shall be capped
at [********] and further provided that CFFT shall not have to fund the portion
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
49
Execution Copy
any such efforts to the extent that costs incurred for such efforts are fairly allocable under
GAAP to activities outside of the Field.
8.4 Abandonment. Notwithstanding any contrary provision contained herein, prior to either
Party (or any Affiliate, licensee, sublicensee, transferee or successor) abandoning any Patent
related to the Research Project (including abandonment for failure to pay any required fees), such
Party shall promptly notify the other Party, or cause the other Party to be notified, of such
pending abandonment, whereupon such other Party shall have the right and opportunity to assume
responsibility for the prosecution of the applicable Patent and to maintain the issued Patent or
continue the prosecution of the patent application at such other Party’s own expense. Each Party
hereby agrees to exercise its good faith efforts to obtain such consents, on the other Party’s
behalf, as may be necessary, advisable and/or appropriate for the other Party to exercise its
rights under this Section 8.4.
8.5 Transfer of Alternative Compounds. EPIX may, in its sole discretion, transfer to CFFT any
Hit Corrector Compound, Hit Potentiator Compound and Hit Dual Potentiator Corrector after an EDC
has been designated and the JSC has determined pursuant to this Agreement that such prior hit
compounds are not to be appropriate for Back Up Compounds. Such transfer shall occur, if at all,
within ninety (90) days after such determination has been made. In the event of an Interruption,
if such compounds have not been previously transferred to CFFT pursuant to the preceding sentence,
they shall be included in the materials and data transferred to CFFT pursuant to Section 9.6(c).
ARTICLE IX — TERM AND TERMINATION
9.1 Term. This Agreement shall become effective as of the Effective Date and, unless earlier
terminated pursuant to the other provisions of this Article IX, shall terminate at
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
50
Execution Copy
such time as when there are no longer any payment obligations owing from one Party to the
other under Article IV hereto.
9.2 Termination by CFFT Without Cause. CFFT may terminate this Agreement within [********]
after each anniversary of the Effective Date by providing to EPIX at least [********] prior notice.
In the event of any such termination, CFFT shall pay to EPIX any amounts accrued and unpaid under
this Agreement as of the effective date of termination and any Milestone Award for any Milestone
Event achieved within [********] after the effective date of such termination.
9.3 Termination by CFFT With Cause. Notwithstanding any provision contained herein or in any
other document to the contrary, CFFT may, without prejudice to any other remedies available to it
at law or in equity, terminate this Agreement upon the occurrence of any of the following events
(each, a “Default”) (provided, however, that, in each instance (other than pursuant to
Section 9.3(d)), EPIX shall have [********] following EPIX’ receipt of written notice from CFFT to
EPIX of the occurrence of a Default to cure such Default and further provided that if such Default
is reasonably susceptible to cure, and EPIX is diligently pursuing a cure, then such cure period
shall be extended by an additional [********]):
(a) any material violation by EPIX of any Applicable Law in the performance of the Research
Program;
(b) any material breach or material default by EPIX in the performance of any of its material
covenants or obligations hereunder,
(c) any representation or warranty made by EPIX in this Agreement is not true in any material
respects as of the date made; and/or
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
51
Execution Copy
(d) a case or proceeding (i) under the bankruptcy laws of the United States now or hereafter
in effect is filed against EPIX or all or substantially all of its assets and such petition or
application is not dismissed within [********] after the date of its filing or EPIX shall file any
answer admitting and not contesting such petition, or (ii) under the bankruptcy laws of the United
States now or hereafter in effect or under any insolvency, reorganization, receivership,
dissolution or liquidation law or statute of any jurisdiction now or hereafter in effect (whether
at law or equity) is filed by EPIX for all or substantially all of its assets.
9.4 Termination for CFFT Breach. EPIX may, without prejudice to any other remedies available
to it at law or in equity, terminate this Agreement in the event CFFT shall have materially
breached or defaulted in the performance of any of its covenants or obligations hereunder, and such
breach or default shall have continued for [********] after written notice thereof was provided to
CFFT by EPIX and further provided that if such Default is reasonably susceptible to cure, and CFFT
is diligently pursuing a cure, then such cure period shall be extended by an additional [********].
9.5 General Effect of Termination; Survival.
(a) Termination or expiration of this Agreement for any reason shall be without prejudice to
any rights that shall have accrued to the benefit of any Party prior to such termination or
expiration. Such termination or expiration shall not relieve any Party from obligations which
accrued prior to the effective date of such termination or which are expressly indicated to survive
termination of this Agreement.
(b) If this Agreement is terminated for any reason, all of the Parties’ rights and obligations
under, and/or the provisions contained in, Sections 2.9, 3.1.2(a)(ii), 3.1.2(a)(iii),
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
52
Execution Copy
3.1.2(b), 3.1.3(a) (third sentence), 3.1.4, 3.1.8, 3.2, 9.5 and 9.6 and Articles IV, V, VI,
VII, VIII, X and XI shall survive termination or expiration of this Agreement.
(c) Subject to the grant of an Interruption License under Section 9.6(a) upon termination or
expiration of this Agreement, EPIX will retain ownership of the EPIX Research Project Technology
and the license granted under Section 8.1 shall become irrevocable and perpetual.
9.6 Interruption License. In the event of an Interruption that is not cured as provided in
Section 9.3, CFFT shall elect within thirty (30) days, to either terminate this Agreement and
pursue such remedies as may be available to it under law, or to elect to accept an Interruption
License (as defined in this Section 9.6). Subject to CFFT’s election to accept an Interruption
License, EPIX hereby grants to CFFT with respect to the Research Project the following license (the
“Interruption License”), which shall become effective solely upon written notice given by
CFFT in the event of an Interruption:
(a) an exclusive (even as to EPIX) worldwide license, with the right to sublicense, under the
EPIX Research Project Technology and the EPIX Background Technology necessary to develop,
manufacture, have manufactured, use, sell, offer to sell and import Products in the Field; provided
that: (i) to the extent any rights licensed hereunder are in-licensed by EPIX from Third Parties,
such Interruption License shall in all respects be governed by and subject to such Third Party
rights, including, for example, that such Interruption License may not be exclusive with respect to
such Third Party rights and that CFFT shall be responsible for making all payments due under such
agreements (other than payments under the Tel Aviv License, which shall remain EPIX’
responsibility) that are required in connection with the grant or the exercise of rights under the
Interruption License and (ii) the Interruption License shall not
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
53
Execution Copy
permit or allow CFFT, its Affiliates or their sublicensees to make any use of, or have any
access to, the Technology licensed by EPIX under the Tel Aviv License nor any screening,
optimization or other in silico technologies Controlled by EPIX.
(b) In the event that EPIX transfers all of or certain of its rights and obligations to
develop and commercialize a Product in the Field at any time, the Third Party to which EPIX
transfers all or certain rights and obligations to develop and commercialize the Product in the
Field shall be subject to the obligations of the Interruption License. The Interruption License
shall be deemed to constitute intellectual property as defined in Section 365(n) of the U.S.
Bankruptcy Code. EPIX agrees that CFFT, as a licensee of such rights, shall retain and may
exercise all of its rights and elections under the U.S. Bankruptcy Code; provided,
however, that nothing in this Agreement shall be deemed to constitute a present exercise of
such rights and elections.
(c) In connection with this Section 9.6, without limitation, EPIX shall deliver to CFFT,
within thirty (30) days of the occurrence of an Interruption, all materials and data generated by
EPIX in the performance of the Research Project that are necessary to the practice the license
described in Section 9.6(a) above.
(d) EPIX shall promptly report to CFFT upon the occurrence of an Interruption explaining the
circumstances of the Interruption and its future intent regarding the continuation of the Research
Project. CFFT may determine in its sole discretion to defer the written notice of effectiveness of
the Interruption License based on such report.
(e) Upon the grant of the Interruption License, the licenses granted hereunder shall terminate
(other than the Interruption License), all of EPIX obligations hereunder shall terminate, except
for those that expressly survive the termination of this Agreement and CFFT
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
54
Execution Copy
shall no longer be required to provide any amounts remaining under the Award other than
payments that were due and owing as of the Effective Date of the grant of the Interruption license.
(f) Except as provided in Section 3.1.8(c), the acceptance by CFFT of an Interruption License
shall be lieu of any and all other claims, rights or remedies that might be available to CFFT
hereunder or at law in connection with such breach or Interruption.
ARTICLE X — REPRESENTATIONS AND WARRANTIES
10.1 Representations, Warranties and Covenants of EPIX. EPIX represents, warrants and
covenants to CFFT that (i) it believes that it has the knowledge, skills, expertise and experience
to perform the Research Project; (ii) it shall use Commercially Reasonable Effort to obtain and/or
maintain all licenses, permits and other approvals and authorizations required to conduct the
Research Project consistent with its obligations pursuant to this Agreement; (iii) with respect to
any Third Party to whom EPIX subcontracts the performance of any aspect of the Research Project,
and subject to Section 11.7, EPIX shall: (A) subcontract only with research entities that it
reasonably believes possess the knowledge, skills, expertise, and experience necessary to perform
such services; (B) use Commercially Reasonable Efforts to ensure that each such subcontractor
possesses and shall maintain all necessary licenses, permits, approvals or authorizations necessary
to conduct work under the Research Project; and (C) use Commercially Reasonable Efforts to ensure
that each such subcontractor conducts all work under the Research Project in conformity with
Applicable Law; and (iv) it has no knowledge that any of the EPIX Background Technology infringes
the intellectual property of a Third Party in the Field.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
55
Execution Copy
10.2 Mutual Representations and Warranties. Each Party hereby represents and warrants to the
other Party that: (a) this Agreement has been duly executed and delivered by such Party and
constitutes the valid and binding obligation of such party, enforceable against such Party in
accordance with its terms, except as enforceability may be limited by bankruptcy, fraudulent
conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting
creditors’ rights generally and by general equitable principles; (b) the execution, delivery and
performance of this Agreement have been duly authorized by all necessary action on the part of such
Party and its directors; (c) the individual executing this Agreement on behalf of such Party is
duly authorized to do so; (d) no provision contained in this Agreement violates any other agreement
to which such Party is bound or otherwise subject; (e) such Party shall perform its obligations
hereunder in substantial conformity with all applicable foreign, federal, state or local laws,
statutes, rules and regulations (collectively, “Applicable Law”), and without limitation,
the Parties certify that they are in compliance with all laws, statutes, and regulations
restricting U.S. persons from dealing with any individuals, entities, or groups subject to Office
of Foreign Assets Control (“OFAC”) sanctions; and (f) such Party shall not enter into any
arrangement, understanding or agreement that conflicts in any manner with this Agreement and such
Party’s obligations and responsibilities hereunder.
ARTICLE XI — MISCELLANEOUS PROVISIONS
11.1 Governing Law. This Agreement shall be governed by and construed in accordance with the
internal laws of the State of Maryland.
11.2 Dispute Resolution.
(a) In the event of any dispute, claim or controversy arising out of, relating to or in any
way connected to the interpretation of any provision of this Agreement, the
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
56
Execution Copy
performance of either Party under this Agreement or any other matter under this Agreement,
including any action in tort, contract or otherwise, at equity or law (a “Dispute”), either
Party may at any time provide the other Party written notice specifying the terms of such Dispute
in reasonable detail. As soon as practicable after receipt of such notice, the Chief Executive
Officers of both CFFT and EPIX shall meet at a mutually agreed upon time and location for the
purpose of resolving such Dispute. The Chief Executive Officers shall engage in good faith
discussions and/or negotiations for a period of up to thirty (30) days to resolve the Dispute or
negotiate an interpretation or revision of the applicable portion of this Agreement which is
mutually agreeable to both Parties without the necessity of formal dispute resolution procedures
relating thereto. During the course of such discussion and/or negotiation, the Parties shall
reasonably cooperate in order so that each of the Chief Executive Officers may be fully informed
with respect to the issues in the Dispute.
(b) In the event that any non-business type Dispute (including whether a Milestone has been
achieved) is not resolved by the Chief Executive Officers pursuant to Section 11.2(a) then the
Dispute shall be referred to an independent scientific expert in the Field appointed by agreement
of the Parties. The independent expert’s decision shall be final and binding and its costs shall
be borne as directed by the independent expert. Each Party shall cooperate in good faith with the
expert. In the event that the Parties are unable to agree as to whether a particular dispute is
governed by this Section 11.2(b), then this Section 11.2(b) shall be utilized to resolve such
dispute.
(c) In the event any business-related Dispute is not resolved by the Chief Executive Officers
pursuant to Section 11.2(a), then the Parties shall resolve such Dispute by final and binding
arbitration. Whenever a Party decides to institute arbitration proceedings, it
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
57
Execution Copy
shall give written notice to that effect to the other party. Arbitration shall be held in the
District of Columbia, according to the then-current commercial arbitration rules of the Center for
Public Resources (“CPR”), except to the extent such rules are inconsistent with this
Section 11.2. The arbitration will be conducted by one (1) arbitrator who shall be reasonably
acceptable to the Parties and who shall be appointed in accordance with CPR rules. If the Parties
are unable to select an arbitrator, then the arbitrator shall be appointed in accordance with CPR
rules. Any arbitrator chosen hereunder shall have educational training and industry experience
sufficient to demonstrate a reasonable level of relevant scientific, financial, medical and
industry knowledge. Within twenty (20) days of the selection of the arbitrator, each Party shall
submit to the arbitrator a proposed resolution of the Dispute that is the subject of the
arbitration (the “Proposals”). The arbitrator shall thereafter select the Proposal so
submitted as the resolution of the Dispute that the Arbitrator determines to be appropriate, but
may not alter the terms of either Proposal and may not resolve the Dispute in a manner other than
by selection of one of the submitted Proposals. If a Party fails to submit a Proposal in
accordance with the terms of this Section 11.2(c), the arbitrator shall select the Proposal of the
other Party as the resolution of the Dispute. The arbitrator shall agree to render its opinion
within thirty (30) days of the final arbitration hearing. No arbitrator shall have the power to
award punitive damages under this Agreement regardless of whether any such damages are contained in
a Proposal, and such award is expressly prohibited. The proceedings and decisions of the
arbitrator shall be confidential, final and binding on all of the Parties. Judgment on the award so
rendered may be entered in a court having jurisdiction thereof. The Parties shall share the costs
of arbitration according to the decision of the arbitrator. Nothing in this Section 11.2(c) will
preclude either Party from seeking equitable relief in accordance with Section 11.3 or interim or
provisional relief from a court of competent
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
58
Execution Copy
jurisdiction, including a temporary restraining order, preliminary injunction or other interim
equitable relief, concerning a dispute either prior to or during any arbitration if necessary to
protect the interests of such Party or to preserve the status quo pending the arbitration
proceeding.
11.3 Equitable Relief. The Parties acknowledge and agree that, in the event of a breach or a
threatened breach by either Party of this Agreement for which it may have no adequate remedy at
law, the other Party may suffer irreparable damage and accordingly, shall be entitled to seek
injunctive and other equitable remedies to prevent or restrain such breach or threatened breach,
without the necessity of posting a bond, in addition to any other remedy they might have at law or
at equity.
11.4 Waiver. No provision of this Agreement may be waived except in writing by both Parties
hereto. No failure or delay by either Party hereto in exercising any right or remedy hereunder or
under Applicable Law will operate as a waiver thereof, or a waiver of any right or remedy on any
subsequent occasion.
11.5 Force Majeure. Neither Party will be in breach hereof by reason of its delay in the
performance of or failure to perform any of its obligations hereunder, if that delay or failure is
caused by strikes, acts of God or the public enemy, riots, incendiaries, interference by civil or
military authorities, compliance with governmental priorities for materials, or any fault beyond
its reasonable control (a “Force Majeure Event”). In such event EPIX or CFFT, as the case
may be, shall immediately notify the other Party of such inability and of the period for which such
inability is expected to continue. The Party giving such notice shall thereupon be excused from
its obligations under this Agreement until the Force Majeure Event ceases. To the extent
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
59
Execution Copy
possible, each Party shall use reasonable efforts to minimize the duration of any Force
Majeure Event.
11.6 Severability. Should one or more provisions of this Agreement be or become invalid, then
the Parties hereto shall attempt to agree upon valid provisions in substitution for the invalid
provisions, which in their economic effect come so close to the invalid provisions that it can be
reasonably assumed that the Parties would have accepted this Agreement with those new provisions.
If the Parties are unable to agree on such valid provisions, the invalidity of such one or more
provisions of this Agreement shall nevertheless not affect the validity of the Agreement as a
whole, unless the invalid provisions are of such essential importance for this Agreement that it
may be reasonably presumed that the Parties would not have entered into this Agreement without the
invalid provisions.
11.7 Assignment. This Agreement may not be assigned or otherwise transferred by either Party,
without the prior written consent of the other Party, except in the event of a Change of Control
Transaction. Except as provided in the previous sentence, in the event of a proposed assignment to
a development partner which EPIX reasonably determines can better advance the commercialization of
the Product[s], EPIX shall notify CFFT at least sixty (60) days prior to the anticipated closing of
such transaction and present with such notice the details of such transaction and the reasons EPIX
believes that such a transaction would not be injurious to the goals of the Research Project.
Thereafter, a meeting of the JSC shall be promptly scheduled to consider whether or not the
proposed transaction is in the best interests of the Research Project. If the JSC determines that
such transaction is in the best interests of the Research Project, the successor, surviving entity,
purchaser of assets, transferee, or other similar party, as applicable, must expressly assumes in
full in writing the transferee’s obligations under this Agreement. Any
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
60
Execution Copy
purported assignment in contravention of this Section 11.8 shall be null and void and of no
effect. No assignment shall release either Party from responsibility for the performance of any
accrued obligation of such Party hereunder. This Agreement shall be binding upon and enforceable
against the successor to or any permitted assignees from either of the Parties hereto.
11.8 Counterparts. This Agreement may be executed in duplicate, each of which shall be deemed
to be original and both of which shall constitute one and the same Agreement.
11.9 No Agency. Nothing herein contained shall be deemed to create an agency, joint venture,
amalgamation, partnership or similar relationship between CFFT and EPIX. Notwithstanding any of
the provisions of this Agreement, neither Party to this Agreement shall at any time enter into,
incur, or hold itself out to Third Parties as having authority to enter into or incur, on behalf of
the other Party, any commitment, expense, or liability whatsoever, and all contracts, expenses and
liabilities in connection with or relating to the obligations of each Party under this Agreement
shall be made, paid, and undertaken exclusively by such Party on its own behalf and not as an agent
or representative of the other.
11.10 Notice. All communications between the Parties with respect to any of the provisions of
this Agreement will be sent to the addresses set out below, or to such other addresses as may be
designated by one party to the other by notice pursuant hereto, by prepaid, certified air mail
(which shall be deemed received by the other Party on the seventh (7th) business day
following deposit in the mails), or by facsimile transmission, or other electronic means of
communication (which shall be deemed received when transmitted), with confirmation by first class
letter, postage pre-paid, given by the close of business on or before the next following business
day:
if to CFFT, at:
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
61
Execution Copy
Xxxxxx X. Xxxxx
President and CEO
Cystic Fibrosis Foundation
0000 Xxxxxxxxx Xxxx, Xxxxx 000
Xxxxxxxx, XX 00000
Tel: (000) 000-0000
Fax: (000) 000-0000
Email: xxx@xxx.xxx
President and CEO
Cystic Fibrosis Foundation
0000 Xxxxxxxxx Xxxx, Xxxxx 000
Xxxxxxxx, XX 00000
Tel: (000) 000-0000
Fax: (000) 000-0000
Email: xxx@xxx.xxx
with a copy to:
Xxxxxxx X. Xxxxxxx, Esq.
0000 X Xxxxxx, X.X.
Xxxxxxxxxx, X.X. 00000
Tel: (000) 000-0000
Fax: (000) 000-0000
Email: Xxx@xxxxxxxxxx.xxx
0000 X Xxxxxx, X.X.
Xxxxxxxxxx, X.X. 00000
Tel: (000) 000-0000
Fax: (000) 000-0000
Email: Xxx@xxxxxxxxxx.xxx
if to EPIX, at:
EPIX Pharmaceuticals, Inc.
0 Xxxxxxx Xxxx
Xxxxxxxxx, XX 00000
Fax: (000) 000-0000
Attn.: Chief Business Officer
0 Xxxxxxx Xxxx
Xxxxxxxxx, XX 00000
Fax: (000) 000-0000
Attn.: Chief Business Officer
with a copy to:
Xxxxxxx Procter
00 Xxxxx Xxxxxx
Xxxxxxxx Xxxxx
Xxxxxx, XX 00000
Fax: (000) 000-0000
Attn.: Xxxxxxxxxxx Xxxx
00 Xxxxx Xxxxxx
Xxxxxxxx Xxxxx
Xxxxxx, XX 00000
Fax: (000) 000-0000
Attn.: Xxxxxxxxxxx Xxxx
11.11 Headings. The paragraph headings are for convenience only and will not be deemed to
affect in any way the language of the provisions to which they refer.
11.12 Entire Agreement. This Agreement contains the entire understanding of the Parties
relating to the matters referred to herein, and may only be amended by a written document, duly
executed on behalf of the respective Parties.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
62
Execution Copy
11.13 Notice of Pharmaceutical Side-Effects. The Parties shall keep each other promptly and
fully informed of (a) any serious adverse event(s) (SAEs) (as defined by the International
Conference of Harmonisation (ICH) guideline, “Clinical Safety Data Management: Definitions and
Standards for expedited reporting E2A” dated 27 October 1994); (b) any follow-up information on an
SAE; or (c) any findings from tests in laboratory animals that suggest a significant risk for human
subjects including reports of mutagenicity, teratogenicity or carcinogenicity; that occur (i)
during the Research Project, (ii) during any further research conducted with respect to the Product
after the Research Termination Date, (iii) during clinical trials of the Product or (iv) after the
First Commercial Sale of the Product. The Parties shall inform each other in writing within a
reasonable period of time, not to exceed thirty (30) days, following receipt of such information
and will promptly notify the appropriate authorities in accordance with Applicable Law.
11.14 Anti-Terrorist Protections.. In accordance with the U.S. Department of the Treasury
Anti-Terrorist Financing Guidelines, EPIX shall take reasonable steps to ensure that the Award and
the Milestone Awards are not distributed to terrorists or their support networks or used for
activities that support terrorism or terrorist organizations. EPIX shall provide a copy of its
standard operating procedure or submit periodic reports to CFFT at CFFT’s request detailing what
steps it has taken to meet this goal.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
63
Execution Copy
IN
WITNESS WHEREOF, the undersigned have executed this Research,
Development and Commercialization Agreement as of the date first
written above.
Cystic Fibrosis Foundation Therapeutics, Inc. | ||||
By: | /s/ Xxxxxx X. Xxxxx | |||
Name: | Xxxxxx X. Xxxxx | |||
Title: | President and CEO | |||
EPIX Pharmaceuticals, Inc. | ||||
By: | /s/ Xxxxxxx X. Xxxxxxxx | |||
Name: | Xxxxxxx X. Xxxxxxxx, M.D., Ph.D. | |||
Title: | CEO |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
64
EXHIBIT A
Budget
Hit Characterization and Lead Optimization Activities
[********]
(A) | Such third party costs will include a one-time expense of approximately [********] for acquiring a hardware computational cluster to support the lead optimization projects and annual software support for computational tools of approximately [********], in both cases paid to third parties for annual licenses of software products for lead optimization. | |
(B) | Equipment amount is based upon the remaining equipment budget at January 1, 2008 from Amendment #3 | |
(C) | Estimated budget paid by the CFFT to Chantest ([********]); CFFT will not use any other budget item to pay for Chantest. |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
Execution Copy
EDC or Back-Up to Phase Iib budget
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
2
EXHIBIT B1
EDC/CLINICAL CANDIDATE CRITERIA
Early (Pre-clinical) Candidate (EDC) Criteria
i) | [********] | |
ii) | [********] | |
iii) | No significant [********] or at [********], whichever is greater | |
iv) | No significant [********] on [********] (such as [********] | |
v) | Acceptable stability in [********] | |
vi) | No significant [********], whichever is greater. | |
vii) | [********] | |
viii) | [********] | |
ix) | [********] | |
x) | [********] | |
xi) | [********] |
1 | The definitions specified in this Exhibit B may be modified by agreement of the JSC and inserted in this Exhibit B in lieu of the criteria originally specified without the need to formally amend this Agreement. Such modification shall also be evidenced in JSC minutes. |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
EXHIBIT
C
MILESTONE AWARDS
Milestone Event | Milestone Award | |
1. Completion of [********], including
[********]
|
[********] | |
2. Identification of [********]
|
[********] | |
3. JSC agreement on [********]
|
[********] | |
4. JSC agreement of [********]
|
[********] | |
5. JSC agreement of [********] that may be
[********]
|
[********] | |
6. [********]
|
[********] | |
7. Completion of [********]
|
[********] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
EXHIBIT D
RESEARCH PLAN
To be inserted after agreement by the JSC within sixty (60) days of the Effective Date.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.