RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT by and between Sangamo BioSciences, Inc. and Juvenile Diabetes Research Foundation International
Exhibit 10.19
NOTE: Portions of this Exhibit are the subject of a Confidential Treatment Request by the
Registrant to the Securities and Exchange Commission (the “Commission”). Such portions have been
redacted and are marked with a “[***]” in place of the redacted language. The redacted information
has been filed separately with the Commission.
by and between
Sangamo BioSciences, Inc.
and
Juvenile Diabetes Research Foundation International
Table of Contents
Page | ||||||
ARTICLE I |
DEFINITIONS | 2 | ||||
1.1 |
Affiliate | 2 | ||||
1.2 |
Agreement | 2 | ||||
1.3 |
Applicable Law | 2 | ||||
1.4 |
Application | 2 | ||||
1.5 |
Award | 2 | ||||
1.6 |
Award Received | 3 | ||||
1.7 |
Commercially Reasonable Efforts | 3 | ||||
1.8 |
Confidential Information | 3 | ||||
1.9 |
Controlled | 3 | ||||
1.10 |
Default | 3 | ||||
1.11 |
Diabetes | 3 | ||||
1.12 |
Dispute | 3 | ||||
1.13 |
Dollars | 3 | ||||
1.14 |
Effective Date | 4 | ||||
1.15 |
FDA | 4 | ||||
1.16 |
Field | 4 | ||||
1.17 |
First Commercial Sale | 4 | ||||
1.18 |
[***] | 4 | ||||
1.19 |
Funding Date | 4 | ||||
1.20 |
GAAP | 4 | ||||
1.21 |
Indemnitee | 4 | ||||
1.22 |
Interruption | 4 | ||||
1.23 |
Interruption License | 5 | ||||
1.24 |
Interruption Notice | 5 | ||||
1.25 |
Interruption Response | 5 | ||||
1.26 |
JDRF | 5 | ||||
1.27 |
JDRF Designees | 5 | ||||
1.28 |
JDRF Indemnitee | 5 | ||||
1.29 |
JDRF Interruption License Technology | 5 |
*** CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
-i-
Table of Contents
(CONTINUED)
(CONTINUED)
Page | ||||||
1.30 |
JDRF Patents | 5 | ||||
1.31 |
JDRF Studies | 5 | ||||
1.32 |
Joint Invention | 5 | ||||
1.33 |
Joint Research Advisory Committee | 5 | ||||
1.34 |
Major Markets | 6 | ||||
1.35 |
Matched Funds | 6 | ||||
1.36 |
Milestones | 6 | ||||
1.37 |
Net Sales | 6 | ||||
1.38 |
Owner | 7 | ||||
1.39 |
Party(ies) | 7 | ||||
1.40 |
Patents | 7 | ||||
1.41 |
Person | 7 | ||||
1.42 |
Policies | 7 | ||||
1.43 |
Primary Statistical Analysis | 7 | ||||
1.44 |
Prime Rate | 8 | ||||
1.45 |
Principal Investigator | 8 | ||||
1.46 |
Product | 8 | ||||
1.47 |
Program Material | 8 | ||||
1.48 |
Qualified Subject | 8 | ||||
1.49 |
Quarterly Report | 8 | ||||
1.50 |
Recipient | 8 | ||||
1.51 |
Recipient Notice Requirement | 8 | ||||
1.52 |
Registration | 8 | ||||
1.53 |
Regulatory Approval | 8 | ||||
1.54 |
Research Plan | 9 | ||||
1.55 |
Research Program | 9 | ||||
1.56 |
Research Termination Date | 9 | ||||
1.57 |
Sangamo | 9 | ||||
1.58 |
Sangamo Designees | 9 | ||||
1.59 |
Sangamo Indemnitee | 9 |
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Table of Contents
(CONTINUED)
(CONTINUED)
Page | ||||||
1.60 |
Sangamo Party | 9 | ||||
1.61 |
Sangamo Patents | 9 | ||||
1.62 |
Sangamo Research Program Technology | 9 | ||||
1.63 |
Surrogate Endpoint Data | 10 | ||||
1.64 |
Territory | 10 | ||||
1.65 |
Therapeutic Candidate | 10 | ||||
1.66 |
Third Party | 10 | ||||
ARTICLE II |
RESEARCH PROGRAM | 10 | ||||
2.1 |
Overview | 10 | ||||
2.2 |
Commencement of the Research Program | 10 | ||||
2.3 |
Research Diligence | 11 | ||||
2.3.1 Generally | 11 | |||||
2.3.2 Obligations of Sangamo | 11 | |||||
2.4 |
Modifications to JDRF Studies | 12 | ||||
2.5 |
Joint Research Advisory Committee | 12 | ||||
2.5.1 Composition and Purposes | 12 | |||||
2.5.2 Meetings | 13 | |||||
2.5.3 Discussions/Recommendations | 14 | |||||
2.5.4 |
Expenses | 15 | ||||
2.6 |
Delivery of Adverse Event Data to the JRAC | 15 | ||||
ARTICLE III |
RESEARCH FUNDING; RECORDS | 15 | ||||
3.1 |
Research Funding | 15 | ||||
3.1.1 Payments | 15 | |||||
3.1.2 Limitations | 15 | |||||
3.1.3 Matched Funds | 16 | |||||
3.1.4 Payments | 17 | |||||
3.1.5 Competition | 17 | |||||
3.2 |
Records; Reporting Obligations; Audits | 17 | ||||
3.2.1 Records | 17 | |||||
3.2.2 Audit | 17 |
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Table of Contents
(CONTINUED)
(CONTINUED)
Page | ||||||
3.2.3 Reports; Notices | 18 | |||||
ARTICLE IV |
DILIGENCE; COMPENSATION TO JDRF | 20 | ||||
4.1 |
Development and Commercialization of Product | 20 | ||||
4.2 |
Compensation to JDRF | 20 | ||||
4.3 |
Sales Reports | 22 | ||||
4.4 |
Royalties to Sangamo | 24 | ||||
ARTICLE V |
CONFIDENTIALITY | 24 | ||||
5.1 |
Confidentiality | 24 | ||||
5.1.1 Definition of Confidential Information | 24 | |||||
5.1.2 Xxx-Xxxxxxxxxx | 00 | |||||
5.1.3 Required Disclosure | 25 | |||||
5.1.4 No Use of Confidential Information | 26 | |||||
5.2 |
Publicity; Use of Name | 26 | ||||
ARTICLE VI |
PUBLICATION | 28 | ||||
ARTICLE VII |
INDEMNIFICATION | 30 | ||||
7.1 |
Indemnification by Sangamo | 30 | ||||
7.2 |
Indemnification by JDRF | 31 | ||||
7.3 |
Claims Procedures | 32 | ||||
7.4 |
Participation; Assuming Control of the Defense | 33 | ||||
7.5 |
Advance Payment of Expenses | 33 | ||||
7.6 |
Limitation of Liability | 33 | ||||
7.7 |
Insurance | 34 | ||||
ARTICLE VIII |
PATENTABLE INVENTIONS | 35 | ||||
8.1 |
Ownership | 35 | ||||
8.2 |
Preparation | 35 | ||||
8.3 |
Costs | 35 | ||||
8.4 |
Abandonment | 36 | ||||
ARTICLE IX |
TERM AND TERMINATION | 36 | ||||
9.1 |
Term | 36 | ||||
9.2 |
Termination by JDRF With Cause | 37 |
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Table of Contents
(CONTINUED)
(CONTINUED)
Page | ||||||
9.3 |
Termination for JDRF Breach | 38 | ||||
9.4 |
General Effect of Termination; Survival | 38 | ||||
9.5 |
Interruption License | 39 | ||||
ARTICLE X |
REPRESENTATIONS AND WARRANTIES | 43 | ||||
10.1 |
Representations, Warranties and Covenants of Sangamo | 43 | ||||
10.2 |
Representations and Warranties of JDRF | 45 | ||||
ARTICLE XI |
MISCELLANEOUS PROVISIONS | 45 | ||||
11.1 |
Governing Law | 45 | ||||
11.2 |
Dispute Resolution | 45 | ||||
11.3 |
Equitable Relief | 47 | ||||
11.4 |
Waiver | 48 | ||||
11.5 |
Force Majeure | 48 | ||||
11.6 |
Severability | 48 | ||||
11.7 |
Assignment | 49 | ||||
11.8 |
Counterparts | 49 | ||||
11.9 |
No Agency | 49 | ||||
11.10 |
Notice | 50 | ||||
11.11 |
Headings | 51 | ||||
11.12 |
Entire Agreement | 51 | ||||
Exhibit A – |
Research Plan | |||||
Exhibit B – |
Research Funding and Milestones | |||||
Exhibit C – |
JDRF Policies and Conditions Regarding Funding of Research Involving Human Clinical Trials | |||||
Exhibit D – |
Form of Press Release |
-v-
This Agreement (this “Agreement”) is made on this 24th day of October, 2006, by and
between Sangamo BioSciences, Inc., a Delaware corporation, with its principal office at 000 Xxxxx
Xxxxxxxxx, Xxxxx X000, Xxxxxxxx, XX 00000 (“Sangamo”) and Juvenile Diabetes Research
Foundation International, a Pennsylvania nonprofit corporation with its principal offices at 000
Xxxx Xxxxxx, Xxx Xxxx, XX 00000 (“JDRF”). This Agreement shall become effective on the
Effective Date (as defined below). Sangamo and JDRF are each a “Party,” and, collectively,
the “Parties.”
WHEREAS, JDRF’s principal charitable mission is the discovery and development of a cure for
diabetes and its complications, to which JDRF brings significant scientific and human resources and
financial support;
WHEREAS, Sangamo desires, among other things, to collect additional clinical endpoints during
the Phase II Repeat Dosing Clinical Trial of SB-509 for the purpose of understanding the
mechanistic basis of efficacy and reversal of neuropathy (as more fully described in the Research
Plan); and
WHEREAS, JDRF wishes to support the Research Program.
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 who 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.
1.2 “Agreement” means 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 “Application” shall mean Sangamo’s submitted Industry Discovery & Development
Partnerships Application, dated May 12, 2006 and approved by JDRF on June 29, 2006.
1.5 “Award” shall mean an amount up to, but not to exceed, Three Million Dollars
($3,000,000), which is to be paid by JDRF to Sangamo for the Research Program in accordance with
the terms, and subject to the conditions, set forth in this Agreement.
2.
1.6 “Award Received” shall mean the amount of the Award actually received by Sangamo
from JDRF pursuant to this Agreement, not including any amounts refunded to JDRF pursuant to
Section 3.2.3(b).
1.7 “Commercially Reasonable Efforts” shall mean a level of effort and application of
expertise and resources that are consistent with a continuing intention to research, develop and
commercialize the Product, including without limitation the reasonable time during which Sangamo is
engaged in active efforts to identify a potential Third Party licensee or collaborator and
negotiate a license or collaboration arrangement with such Third Party to research, develop and/or
commercialize the Product, it being acknowledged by the Parties that there may be delays for
regulatory or other reasons that are not within Sangamo’s or its licensee’s, sublicensee’s or
transferee’s control and such delays shall not constitute a cessation of Commercially Reasonable
Efforts.
1.8 “Confidential Information” shall have the meaning set forth in Section 5.1.1.
1.9 “Controlled” (except in the context of Section 1.1) shall mean the legal authority
or right of a Party to grant a license or sublicense of intellectual property rights to the other
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.
1.10 “Default” shall have the meaning set forth in Section 9.2.
1.11 “Diabetes” shall mean any one and/or all of the human diseases commonly known as
diabetes and the complications of such diseases.
1.12 “Dispute” shall have the meaning set forth in Section 11.2(a).
1.13 “Dollars” shall have the meaning set forth in Section 3.1.4.
3.
1.14 “Effective Date” shall mean the date the last Party signs this Agreement.
1.15 “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.
1.16 “Field” shall mean the diagnosis, treatment and/or prevention of Diabetes in
humans.
1.17 “First Commercial Sale” shall mean the first sale of the Product by Sangamo or an
Affiliate, licensee, sublicensee, transferee or successor of Sangamo to an independent Third Party
in a Major Market country following Regulatory Approval of the Product in that country.
1.18 “[***]” shall have the meaning set forth in Section 4.2(b).
1.19 “Funding Date” shall mean each date set forth on Exhibit B.
1.20 “GAAP” shall mean United States generally accepted accounting principles,
consistently applied.
1.21 “Indemnitee” shall mean either Sangamo Indemnitee or JDRF Indemnitee, as
applicable.
1.22 “Interruption” shall occur if, at any time before the First Commercial
Sale of the Product, Sangamo, its Affiliates, licensees, sublicensees, transferees and/or
successors, all cease to conduct, or have ceased Commercially Reasonable Efforts with respect to,
the research, development and/or commercialization of all Products for a period of [***]
consecutive days, except that no Interruption shall be deemed to have occurred, if Sangamo, its
Affiliates, licensees, sublicensees, transferees, and/or successors suspend, postpone or
discontinue the
*** CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
-4-
development or commercialization of a Product on account of (a) a serious adverse event; (b) a
clinical hold; or (c) communications with a regulatory authority.
1.23 “Interruption License” shall have the meaning set forth in Section 9.5(e).
1.24 “Interruption Notice” shall have the meaning set forth in Section 9.5(a).
1.25 “Interruption Response” shall have the meaning set forth in Section 9.5(a).
1.26 “JDRF” shall have the meaning set forth in the preamble of this Agreement.
1.27 “JDRF Designees” shall have the meaning set forth in Section 2.5.1.
1.28 “JDRF Indemnitee” shall have the meaning set forth in Section 7.1.
1.29 “JDRF Interruption License Technology” shall mean all intellectual property,
data, technical information, know-how, inventions (whether or not patented), trade secrets,
processes and methods that are (a) discovered or developed by or on behalf of JDRF or its
Affiliates, in the performance of the Research Program or exploitation of the Interruption License
under this Agreement, (b) Controlled by JDRF, and (c) necessary or useful for the research,
development and commercialization of the Product.
1.30 “JDRF Patents” shall mean any Patents Controlled by JDRF or its Affiliates that
claim an invention that relates to the Research Program but is not a Joint Invention.
1.31 “JDRF Studies” shall mean the mechanistic add-on studies for the collection of
Surrogate Endpoint Data that are described in the Application.
1.32 “Joint Invention” shall have the meaning set forth in Section 8.1.
1.33 “Joint Research Advisory Committee” or “JRAC” shall have the meaning set
forth in Section 2.5.1.
5.
1.34 “Major Markets” shall mean the United States, United Kingdom, Germany, France,
Italy and Spain.
1.35 “Matched Funds” shall have the meaning set forth in Section 3.1.3.
1.36 “Milestones” shall mean the performance milestones for the Research Program set
forth in Exhibit B.
1.37 “Net Sales” means, for any period, the gross price received for the Product sold
or otherwise disposed of (other than for use as clinical supplies or free samples) for
consideration by Sangamo or its Affiliates to Third Parties other than sublicensees, reduced by the
following amounts (calculated in accordance with GAAP consistently applied by Sangamo and its
Affiliates across its product lines), if not previously deducted from the amount invoiced: (a)
amounts actually allowed as trade, volume or quantity discounts, including early pay cash
discounts; (b) amounts repaid or credited by reason of defects, recalls, accrued or actual returns,
rebates and allowances of goods or because of retroactive price reductions specifically
identifiable to the Product; (c) rebates and administrative fees paid to medical health care
organizations in line with approved contract terms; (d) rebates resulting from government (or
agency thereof) mandated rebate programs or chargeback programs; (e) rebates paid to wholesalers
for inventory management programs or distribution management agreements, in accordance with
Sangamo’s practice reasonably consistently applied; (f) discounts pursuant to indigent patient
programs and patient discount programs to include coupons and vouchers to the extent included in
Net Sales; (g) retroactive and temporary price reductions that are actually allowed or granted; (h)
sales commissions paid to Third Party distributors or selling agents (which shall not include sales
organizations, whether contract or internal to Sangamo); (i) sales or excise taxes, custom duties,
and other governmental charges (including payments made to
6.
United Kingdom government departments under the UK Pharmaceutical Pricing Regulatory Scheme or
similar programs, and government taxes, charges or penalties, such as French Social Security
rebates, which payments need not be calculated in accordance with GAAP) imposed directly on and
actually paid by Sangamo or its Affiliates; and (j) transportation costs, including insurance and
shipping, freight, and handling charges, to the extent billed separately to customers.
1.38 “Owner” shall have the meaning set forth in Section 5.1.2.
1.39 “Party(ies)” shall have the meaning set forth in the preamble of this Agreement.
1.40 “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, any confirmation patent or registration patent or
patent of addition based on any such patent, and all foreign counterparts of any of the foregoing.
1.41 “Person” means any individual, corporation, partnership, association, joint-stock
company, trust, unincorporated organization or government or political subdivision thereof.
1.42 “Policies” shall have the meaning set forth in Section 10.1(b).
1.43 “Primary Statistical Analysis” shall mean the analysis performed of the six (6)
month follow up of all clinical endpoints of all evaluable patients participating in Sangamo’s
Phase II Repeat Dosing Clinical Trial of SB-509.
7.
1.44 “Prime Rate” shall mean the average prime rate published in the Wall Street
Journal during the relevant period (calculated by dividing (a) the sum of the prime rates for each
of the days during the relevant period, by (b) the number of days in the relevant period).
1.45 “Principal Investigator” shall mean the Chief Medical Officer of Sangamo, who
will personally conduct or supervise the Research Program.
1.46 “Product” shall mean (a) the pharmaceutical product containing the Therapeutic
Candidate or (b) any derivatives or related products that (i) encode a zinc finger DNA-binding
protein designed to activate the expression of vascular endothelial growth factor (VEGF-A) and (ii)
result from Sangamo’s research for treatment of diabetic neuropathy.
1.47 “Program Material” shall have the meaning set forth in Section 2.3.2(d).
1.48 “Qualified Subject” is a human subject who, on enrollment into the Research Plan,
has met all of the eligibility criteria and none of the exclusion criteria in the Research Plan and
has given his or her written informed consent to participate in the Research Plan.
1.49 “Quarterly Report” shall have the meaning set forth in Section 3.2.3(a).
1.50 “Recipient” shall have the meaning set forth in Section 5.1.2.
1.51 “Recipient Notice Requirement” shall have the meaning set forth in Section 5.1.3.
1.52 “Registration” shall mean, with respect to each country in the Territory,
Regulatory Approval for the Product filed in such country.
1.53 “Regulatory Approval” shall mean, with respect to any country, all authorizations
by the appropriate governmental entity or entities necessary for commercial sale of the Product in
that country including, without limitation and where applicable, approval of labeling, price,
reimbursement and manufacturing, in the United States final approval of a new drug application
8.
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, and in the European Union final approval of a Marketing
Authorization Application, or equivalent.
1.54 “Research Plan” means the written protocol for Sangamo’s Phase II Repeat Dosing
Clinical Trial of SB-509, that shall be attached to this Agreement as Exhibit A upon
approval by the FDA, which protocol was based on the Application, includes the JDRF Studies, and
has been approved by the FDA, as modified from time to time by Sangamo in consultation with the FDA
and in accordance with Section 2.4.
1.55 “Research Program” shall mean the work conducted by or on behalf of Sangamo in
furtherance of the Research Plan.
1.56 “Research Termination Date” shall mean the date of completion of all activities
specified in the Research Plan, including all follow-ups of Qualified Subjects and all analysis
included in the JDRF Studies.
1.57 “Sangamo” shall have the meaning set forth in the preamble of this Agreement.
1.58 “Sangamo Designees” shall have the meaning set forth in Section 2.5.1.
1.59 “Sangamo Indemnitee” shall have the meaning set forth in Section 7.2.
1.60 “Sangamo Party” shall have the meaning set forth in Section 7.1(a).
1.61 “Sangamo Patents” shall mean any Patents Controlled by Sangamo or its Affiliates
claiming Sangamo Research Program Technology.
1.62 “Sangamo Research Program Technology” shall mean all intellectual property, data,
technical information, know-how, inventions (whether or not patented), trade secrets,
9.
processes and methods that are (a) discovered or developed by or on behalf of Sangamo or its
Affiliates, in the performance of the Research Program under this Agreement, (b) Controlled by
Sangamo, and (c) necessary or useful for the research, development and commercialization of the
Product.
1.63 “Surrogate Endpoint Data” shall have the meaning set forth in Article VI.
1.64 “Territory” shall mean worldwide.
1.65 “Therapeutic Candidate” shall mean the plasmid, known as SB-509, that encodes a
zinc finger DNA-binding protein designed to upregulate the expression of vascular endothelial
growth factor (VEGF-A).
1.66 “Third Party” shall mean any Person which is not a Party or an Affiliate of any
Party to this Agreement.
ARTICLE II RESEARCH PROGRAM
2.1 Overview. Sangamo shall be responsible for the conduct of the Research Program as set
forth herein. JDRF shall provide the financial support hereinafter specified, and consultation and
advice as provided herein through its participation on the JRAC as provided below.
2.2 Commencement of the Research Program. If not commenced prior to the Effective Date, the
Research Program shall commence as soon after the Effective Date as practicable in light of the
date of the FDA’s approval of the Research Plan. If the Research Plan is approved by the FDA after
the Effective Date and substantial changes are made to the JDRF Studies as described in the
Application, then JDRF shall have the right to terminate this Agreement within ten (10) days
following such approval of the Research Plan.
10.
2.3 Research Diligence.
2.3.1 Generally. Sangamo shall use Commercially Reasonable Efforts to: (a) conduct the
Research Program in accordance with the Research Plan; and (b) satisfy and achieve the Milestones.
In furtherance of the foregoing, and in accordance with the terms and conditions of this Agreement
(including, without limitation, Section 2.3.2 below), Sangamo shall commit to the Research Program
directly or through Third Party contractors (i) the level of staffing required by the Research
Plan, with staff that possesses appropriate experience, training and scientific expertise for the
tasks to which they are assigned, and (ii) the infrastructure (e.g., laboratories, offices,
equipment and facilities) required by the Research Plan.
2.3.2 Obligations of Sangamo. Subject to the terms and conditions of this Agreement, and
without limiting the generality of Section 2.3.1 above, Sangamo directly or through its Third Party
contractors shall be responsible for conducting the sponsorship, conduct and oversight of the
Research Program, such responsibilities to include, without limitation:
(a) identifying appropriate clinical sites to conduct the Research Plan, and entering into
clinical trial agreements with such clinical sites;
(b) providing the approved clinical sites with a copy of the Research Plan;
(c) identifying, selecting, and enrolling Qualified Subjects;
(d) providing the investigators at approved clinical sites with the required quantity of the
Product or placebo (the “Program Material”), appropriately formulated in accordance with
the Research Plan;
(e) monitoring compliance of the approved clinical sites with the Research Plan;
(f) monitoring adverse events arising in the course of the Research Program;
11.
(g) providing the investigators at approved clinical sites and JDRF (the latter for
informational purposes) with a copy of the current investigator brochure;
(h) performing laboratory analyses on biopsies collected from Qualified Subjects as outlined
in the Research Plan;
(i) complying with all Applicable Law and guidelines regarding administration, transportation,
manufacture and production of the Program Material and any other drugs or fluids which are to be
supplied by Sangamo for use in connection with the Research Plan;
(j) abiding by and complying with the Policies; and
(k) promptly and thoroughly responding to all reasonable requests and inquiries of JDRF for
information regarding the Research Program.
2.4 Modifications to JDRF Studies. Sangamo shall not propose to the FDA any changes to the
Research Plan that would have a material impact on the JDRF Studies without first presenting such
changes to the JRAC and obtaining the JRAC’s recommendation of such changes.
2.5 Joint Research Advisory Committee.
2.5.1 Composition and Purposes. During the term of the Research Program, the Parties shall
establish a Joint Research Advisory Committee (“JRAC”) consisting of four (4) members, two
(2) of whom shall be designated by Sangamo (the “Sangamo Designees”), and two (2) of whom
shall be designated by JDRF (the “JDRF Designees”). Each Party (a) shall select a program
coordinator from among its designees to the JRAC (who may be changed at any time or from time to
time by such Party), and (b) may change any of its designees to the JRAC at any time or from time
to time. The program coordinator of Sangamo shall serve as the
12.
Chairperson of the JRAC. The Sangamo Designees initially shall be Xxxxx Xxx and Xxxx Xxxx, who
also initially shall serve as Sangamo’s program coordinator and the Chairperson of the JRAC, and
the JDRF Designees initially shall be Xxxxxxx Xxxxx and Xxxx Xxxx, who also initially shall serve
as JDRF’s program coordinator.
The JRAC shall have the authority to:
(i) facilitate communication between the Parties with respect to the Research Program;
(ii) receive Quarterly Reports from Sangamo with respect to the progress of the Research
Program and consider and discuss such reports;
(iii) determine whether the Milestones have been satisfied and achieved; and
(iv) decide whether to recommend any changes presented by Sangamo in accordance with Section
2.4.
2.5.2 Meetings. The JRAC shall meet once in each six (6) month period between the Effective
Date and the Research Program Termination Date; provided, however, the JRAC shall meet within
forty-five (45) days following JDRF’s receipt from Sangamo of a written certification setting forth
Sangamo’s achievement of a Milestone. Meetings of the JRAC shall be held at such times and
locations as may be mutually agreed upon by the program coordinators, which times and locations
shall be communicated in writing (including, without limitation, by email) to the other members of
the JRAC with reasonable advance notice of the meeting. At least one (1) Sangamo Designee and one
(1) JDRF Designee shall be required to participate in a meeting for such meeting to be deemed to
have a quorum of the JRAC members. So long as a quorum is present at a meeting, the JRAC may make,
or decide to make, recommendations to Sangamo, or take, or decide to take, such actions as are
within the scope of
13.
the JRAC’s authority hereunder. Members of the JRAC 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,
Sangamo shall deliver (including by email) to JDRF a written report detailing the progress made on
the Research Program since the last meeting of the JRAC. In satisfaction of such written report,
Sangamo may provide the most recent Quarterly Report supplemented by any new significant
developments since the most recent Quarterly Report. Within thirty (30) days after the date of
each meeting, the Sangamo Designees shall prepare and deliver (including by email) to the JDRF
Designees written minutes of such meeting setting forth in detail all discussions and/or
recommendations of the JRAC made at such meeting, which minutes shall be subject to revision to
take account of the comments of JDRF’s program coordinator.
2.5.3 Discussions/Recommendations.
(a) As a general matter, and except as otherwise provided for herein, recommendations of the
JRAC shall be unanimous and non-binding.
(b) Notwithstanding the foregoing, the determination as to whether or not a Milestone has been
achieved and satisfied shall be subject to the unanimous vote of the JRAC. In each such instance,
the Sangamo Designees shall, collectively, have one (1) vote, and the JDRF Designees shall,
collectively, have one (1) vote, which, in each instance, shall be cast by each Party’s program
coordinator (unless such Party’s program coordinator expressly authorizes such Party’s other JRAC
designee to cast such Party’s vote). In the event of a deadlock, the Sangamo Designees and the
JDRF Designees 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
14.
twenty (20) day period, then, such deadlock shall be resolved in accordance with the dispute
resolution process set forth in Section 11.2.
2.5.4 Expenses. Each Party shall pay its own expenses (including travel and lodging expenses)
incurred in connection with its participation on the JRAC.
2.6 Delivery of Adverse Event Data to the JRAC. In the event of a serious adverse event (as
defined by the ICH Harmonized Tripartite Guideline on Clinical Safety Data Management), directly or
indirectly attributable to the use or application of the Product, Sangamo shall deliver to each
JRAC member any information and other data related to such adverse event within a reasonable time
after Sangamo has had an opportunity to discuss such adverse event with the FDA. Any disclosure of
patient-identifiable information of any Qualified Subject in connection with the Quarterly Reports
due under Section 3.2.3(a) or any other reporting requirements hereunder shall comply with the
Health Insurance and Portability and Accountability Act of 1996 and regulations, laws and
guidelines related thereto.
ARTICLE III RESEARCH FUNDING; RECORDS
3.1 Research Funding.
3.1.1 Payments. Subject to Section 3.1.2, JDRF shall make payments to Sangamo of the Award in
accordance with Exhibit B.
3.1.2 Limitations. Notwithstanding Section 3.1.1 above, JDRF shall not be required to make
any payment or additional payment in respect of the Award:
(a) in excess of Three Million Dollars ($3,000,000);
(b) unless at the time such payment is due, the Research Program is in compliance with all
Applicable Law;
15.
(c) if Sangamo is, at the time such payment is due, in material breach of any of its covenants
or obligations under this Agreement (including, without limitation, Sangamo’s obligations under
Section 3.1.3 below) and JDRF provides Sangamo with written notification of such breach at least
thirty (30) days before such payment due date;
(d) if, at the time such payment is due, a case or proceeding (i) under the bankruptcy laws of
the United States now or hereafter in effect is filed against Sangamo or all or substantially all
of its assets and such petition or application is not dismissed within sixty (60) days after the
date of its filing or Sangamo 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 Sangamo for all or
substantially all of its assets; and/or
(e) if this Agreement previously is terminated by any Party in accordance with
Article IX, provided, however, that any payments accrued prior to such termination
shall immediately become due and payable to Sangamo upon such termination;
provided, however, that JDRF shall pay Sangamo any amount not paid on account of subsection (b),
(c) or (d) above as soon as the condition that caused such non-payment has been remedied or no
longer exists.
3.1.3 Matched Funds. The Parties agree, acknowledge and recognize that the Award represents
only partial financial support for the Research Program, and Sangamo agrees to provide the balance
of the funds necessary to conduct and complete the Research Program. In furtherance of, but
without limiting the generality of the foregoing, Sangamo shall contribute to the Research Program,
in the aggregate, an amount that is at least equal to the Award Received
16.
(the “Matched Funds”). Sangamo hereby covenants and agrees to solely use the Award
Received and the Matched Funds to fund the Research Program.
3.1.4 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 cashier’s or certified check or by wire transfer
of immediately available funds.
3.1.5 Competition. Sangamo hereby agrees and acknowledges that nothing contained herein shall
restrict or prevent JDRF’s ability to provide funding to, or take any other action with respect to,
any Person that competes with the business, operations and/or research of Sangamo,
provided, however, that in no event shall JDRF disclose to such Persons any
non-public information concerning the Research Program, including the results thereof.
3.2 Records; Reporting Obligations; Audits.
3.2.1 Records. Sangamo shall prepare and maintain complete and accurate books
and records in accordance with GAAP documenting its expenditure of funds in connection with the
Research Program (including financial records of expenditures of the Award Received and the Matched
Funds), and shall keep all such books and records for no less than a period of three (3) years
following the Research Termination Date.
3.2.2 Audit. At the request of JDRF not more often than once in each twelve (12) month
period, Sangamo shall permit JDRF internal accounting personnel or representatives and agents of an
independent, certified public accounting firm appointed by JDRF and reasonably acceptable to
Sangamo, to audit and examine, during normal business hours, the financial records of Sangamo
covering the previous twelve (12) month period as may be
17.
necessary to verify Sangamo’s expenditures of funds in connection with performance of the
Research Program in general and the JDRF Studies in particular. Any and all records audited and
examined by JDRF personnel or such representatives and agents of such accounting firm shall be
deemed Sangamo’s Confidential Information. JDRF shall pay the costs of such audit and examination
of such financial records, provided, however, that, if such audit and examination
reveals an over-reporting by Sangamo to JDRF of Matched Funds or expenditures attributed to the
JDRF Studies of more than [***], then the reasonable costs of such audit and examination shall be
borne by Sangamo and Sangamo shall reimburse JDRF for all of the reasonable costs and expenses
incurred by JDRF in connection with such audit and examination.
3.2.3 Reports; Notices. Sangamo shall (y) maintain a system of accounting in accordance with
GAAP; and (z) furnish to JDRF the following reports and notices under the confidentiality
provisions of Article V:
(a) As soon as practicable, and in any event within ninety (90) days after the end of each
calendar quarter (including the calendar quarter ending December 31) prior to the Research
Termination Date, a report describing (i) the actual costs of the Research Program during such
quarter and how the Award Received and Matched Funds have been allocated and in fact used in
respect of the Research Program, (ii) the Research Program work performed during such quarter,
including, without limitation, Milestones achieved, (iii) a summary of all Research Program
clinical data collected and analyzed during such quarter, (iv) a summary of all regulatory filings
made during such calendar that materially alter the Research Plan, and (v) any other information
that JDRF reasonably requests (each a “Quarterly Report”).
(a)(b) As soon as practicable, and in any event within ninety (90) days after the end
of the calendar quarter in which the Research Termination Date occurs or the
*** CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
18.
termination of the Agreement becomes effective, whichever is earlier, a closing report which
(i) sets forth Sangamo’s final analysis, summary tables, data listings, results and conclusions
from the Research Program and such other information and materials as JDRF may reasonably request
and (ii) provides an accounting of the out-of-pocket expenses incurred by Sangamo since the
Effective Date with respect to performance of the JDRF Studies. If the total amount of such
expenses is less than the total Award Received, then, Sangamo shall, within thirty (30) days after
delivery of the closing report, refund the difference between such total expenses and the total
Award Received in such manner as JDRF shall reasonably instruct Sangamo. Such closing report shall
be in lieu of a Quarterly Report covering the last calendar quarter of the Research Program.
(c) Within sixty (60) days after the end of each fiscal year, audited financial
statements as of the end of such year (including, without limitation, a copy of the consolidated
balance sheet of Sangamo as of the end of such year, together with consolidated statements of
income, operations, cash flow and retained earnings of Sangamo for such year), prepared in
accordance with GAAP, along with a comparison of such financial statements with the corresponding
periods of the prior year. Notwithstanding the foregoing, the scope of the information to be
included in the report due under this Section 3.2.3(c) shall be no more extensive or detailed than
the scope of financial disclosures that Sangamo is required to make by the Securities and Exchange
Act of 1934, as amended.
(d) As soon as practicable, and in any event within thirty (30) days after the end of each
calendar year following the Research Termination Date, a report summarizing the Product development
and commercialization activities performed by or on behalf of Sangamo or its Affiliates,
collaborators, licensees or sublicensees during such year.
19.
(e) As soon as practicable, and in any event promptly after the consummation thereof, any
proposed license, sublicense, transfer, or subcontract by Sangamo of rights related to the
research, development, and/or commercialization of the Product, any permitted assignment by Sangamo
of this Agreement or its rights and/or obligations hereunder, or of any merger, acquisition,
consolidation or similar transaction involving Sangamo and materially affecting JDRF’s rights
and/or obligations hereunder.
ARTICLE IV DILIGENCE; COMPENSATION TO JDRF
4.1 Development and Commercialization of Product. Following the Research Termination Date,
Sangamo shall use Commercially Reasonable Efforts to develop, commercialize and bring one Product
in the Field to market in the Major Markets. The activities of Sangamo’s Affiliates, licensees,
sublicensees, subcontractors, collaborators, transferees and successors shall be attributed to
Sangamo for the purposes of determining Sangamo’s satisfaction of the foregoing diligence
obligation.
4.2 Compensation to JDRF.
(a) In consideration of JDRF’s payments to Sangamo and JDRF’s licenses to Sangamo hereunder,
Sangamo shall pay JDRF an amount equal to three (3) times the Award Received less all payments made
pursuant to Section 4.2(b) (such amount, the “JDRF ROI”) as follows: within ninety (90) days of the
first, second, third and fourth anniversaries of the First Commercial Sale, Sangamo shall pay JDRF
an amount equal to: (i) [***] of the JDRF ROI, (ii) [***] of Net Sales during the 12-month period
between such anniversary and the previous anniversary of the First Commercial Sale, as applicable
(such period, the “Relevant Period”), or (iii) [***] of the royalties received by Sangamo
during the Relevant Period from its licensees and sublicensees on account of the sale of the
Product, whichever is less, provided that such amounts
*** CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
20.
shall be reduced as necessary to ensure that the total amount paid, when this Section 4.2(a)
is combined with all payments made pursuant to Section 4.2(b), shall not exceed three (3) times the
Award Received. If the amount paid to JDRF in any year is less than [***] of the JDRF ROI plus any
deficit from a preceding year of JDRF ROI (in each case after crediting all payments made in such
year pursuant to Section 4.2(b)), any such deficit shall be carried forward and added to the amount
applicable under Section 4.2(a)(i) for the following year. If the total amount paid by Sangamo to
JDRF pursuant to this Section 4.2 by the date that is [***] days after the fourth anniversary of
the First Commercial Sale is less than the [***], then Sangamo shall continue to make payments in
accordance with this Section 4.2 in the following years equal [***], or the lesser of [***] to JDRF
within ninety (90) days of each subsequent such anniversary until such time as the total amount
paid by Sangamo equals the [***].
(b) If Sangamo is commercializing the Product in connection with any license,
transfer, or sale of the Sangamo Research Program Technology, any Sangamo Patents, or any Product,
to a Third Party, then Sangamo shall pay to JDRF in cash [***] of the gross proceeds that are
received by Sangamo on or after [***] and prior to the time of Regulatory Approval of the Product
in connection with any such license, transfer, or sale, whether such payments are upfront license
fees, milestone payments, or other fees, but excluding FTE payments or purchases of equity at or
below fair market value (the “[***]”), up to an aggregate amount equal to [***] times the amount of
the Award Received. Such payments to JDRF will be made within ninety (90) days of receipt of such
gross proceeds from any licensee, transferee or purchaser of Sangamo Research Program Technology.
Thereafter, Sangamo shall pay any remaining JDRF ROI to JDRF in accordance with Section 4.2(a).
For clarity, Sangamo shall not
*** CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
21.
be obligated to pay JDRF, in the aggregate, an amount more than three (3) times the Award
Received when the amounts paid under this Section 4.2(b) and Section 4.2(a) are combined.
(c) If aggregate Net Sales of the Product exceed [***] Dollars on or before the
fifth (5th) anniversary of the First Commercial Sale, Sangamo shall pay to JDRF within
ninety (90) days after such Net Sales are achieved an additional royalty equal to the amount of the
Award Received.
(d) If aggregate Net Sales of the Product exceed [***] Dollars on or before the fifth
(5th) anniversary of the First Commercial Sale, Sangamo shall pay to JDRF within ninety
(90) days after such Net Sales are achieved, an additional royalty equal to the amount of the Award
Received.
4.3 Sales Reports.
4.3.1 In connection with each payment made to JDRF pursuant to Section 4.2 above with respect
to which the amount of Net Sales is relevant, Sangamo shall furnish or cause to be furnished to
JDRF a written sales report setting forth in reasonable detail amounts received with respect to
which Net Sales during such period were calculated. With respect to sales of the Product invoiced
in Dollars, the Net Sales amounts and the amounts due to JDRF hereunder shall be expressed in
Dollars. With respect to sales of the Product invoiced in a currency other than Dollars, the Net
Sales and amounts due to JDRF hereunder shall be expressed in the domestic currency of the country
in which the sale was made, together with the Dollar equivalent of the amount payable to JDRF,
calculated by translating foreign currency sales into Dollars in a manner that is consistent with
the then-current foreign currency calculations that Sangamo employs for purposes of its reporting
obligations under the Securities and Exchange Act of 1934, as amended. If any licensee or
sublicensee makes any sales invoiced in a currency other than its
*** CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
22.
domestic currency, the Net Sales shall be converted to its domestic currency in accordance
with the licensee’s or sublicensee’s normal accounting principles. Sangamo shall keep accurate
records in sufficient detail to enable the amounts due hereunder to be determined and to be
verified by JDRF.
4.3.2 Upon the written request of JDRF, at JDRF’s expense and not more often than once a year,
Sangamo shall permit an independent accountant selected by JDRF and reasonably acceptable to
Sangamo to have access during normal business hours to the records of Sangamo from the previous
twenty-four month period (“Audit Period”) as may be reasonably necessary to verify the
accuracy of the report furnished by Sangamo pursuant to Section 4.3.1. Such independent accountant
may examine and audit the records from each Audit Period only once. Such independent accountants
may be required by Sangamo to enter into a reasonably acceptable confidentiality agreement, and in
no event shall such accountants disclose to JDRF any information, other than the accuracy of
reports and payments made or due hereunder.
4.3.3 In case of any delay in payment by Sangamo to JDRF or by JDRF to Sangamo not
occasioned by force majeure in accordance with Section 11.5, interest shall be calculated at the
lesser of (i) the Prime Rate plus five (5) percentage points or (ii) the maximum rate allowed by
law, calculated from the tenth (10th) day after the date upon which the applicable
payment first becomes due from Sangamo.
4.4 Royalties to Sangamo. In the event that, pursuant to Section 9.5, the Interruption
License becomes effective and thereafter is maintained by JDRF, in lieu of any other royalties
pursuant to this Agreement (other than royalties or payments under Section 4.2 previously paid by
Sangamo to JDRF in accordance with this Agreement), the Parties shall [***], subject to this
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23.
Section 4.4, any amount JDRF receives with respect to the Product (including amounts received
in connection with sublicenses of the Interruption License). [***]
ARTICLE V CONFIDENTIALITY
5.1 Confidentiality.
5.1.1 Definition of Confidential Information. For purposes of this Agreement,
“Confidential Information” shall mean any trade secrets, know-how, confidential or
proprietary information, data and test results relating to the Research Program and 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 or has
taken reasonable measures to protect; provided, however, that “Confidential
Information” shall not include any information of Owner that: (a) is already independently
known to Recipient (as defined below) at the time of its disclosure without any obligations of
confidentiality; (b) becomes publicly known through no wrongful act of Recipient; (c) is received
from a Third Party free to disclose it to Recipient without any obligations of confidentiality with
respect thereto; or (d) is independently developed by Recipient without use of any Confidential
Information of the Owner; provided, that, in each such instance, Recipient shall bear the
burden of proving that any such information of Owner is not Confidential Information. Confidential
Information of Sangamo shall include without limitation, investigator brochures, any reports,
notices, data, results, case report forms and regulatory filings generated pursuant to the Research
Program. The terms and conditions of this Agreement shall be the Confidential Information of both
Parties.
*** CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
24.
5.1.2 Non-Disclosure. During the term of this Agreement 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, other than as expressly
provided herein or without first obtaining the prior written consent of Owner, shall not disclose
any Confidential Information to any Person, except to officers, directors, employees, consultants,
committee members, volunteers, contractors, subcontractors, licensees, sublicensees, accountants or
counsel of Recipient who have a need to know and who are bound to confidentiality obligations at
least as restrictive as Recipient’s obligations under this Agreement. Recipient shall use not less
than the same degree of care it uses to avoid disclosure of 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 valid and
existing order of a court of competent jurisdiction or other governmental body or agency;
provided, however, that, Recipient shall have first given prompt notice to Owner of
any possible or prospective order 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
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.
25.
5.1.4 No Use of Confidential Information. Recipient hereby agrees and acknowledges that,
other than as provided herein or without first obtaining Owner’s prior written consent, Recipient
shall not use any of Owner’s Confidential Information.
5.2 Publicity; Use of Name.
5.2.1 As soon as practicable after the Effective Date and not later than the deadline for any
required disclosure of the execution of this Agreement, the Parties shall issue a joint press
release announcing the execution of this Agreement in substantially the same form as the press
release attached as Exhibit D.
5.2.2 Except to the extent already disclosed in the initial press release 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 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. This Section 5.2.2
shall not preclude any Party from issuing press releases or making public announcements if such
Party reasonably believes that any such release or announcement is (a) legally required by
Applicable Laws or (b) required by the rules of any stock exchange on which such Party’s securities
are listed. Sangamo shall accord JDRF the opportunity to review and comment on any submission of
this Agreement and redaction thereof required to be submitted to the Securities and Exchange
Commission by Sangamo. For clarity, Sangamo shall have the right to issue press releases without
obtaining the consent of JDRF so long as such press releases
26.
contain substantially the same information as contained in Sangamo’s Form 8-K filings made
pursuant to the Securities and Exchange Act of 1934, as amended.
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 where practicable 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, where practicable,
shall include JDRF-approved language acknowledging JDRF’s funding of a portion of the Research
Program.
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 JDRF of its research portfolio and of its industry discovery and
development program, and/or (b) JDRF’s fundraising activities, marketing materials and/or reporting
requirements, JDRF shall be entitled to use and/or disclose, and Sangamo hereby pre-approves JDRF’s
use and/or disclosure of: (i) the names “Sangamo,” “Sangamo BioSciences, Inc.”, Sangamo’s logo and
a general description of Sangamo, (ii) the existence and a general description of the nature of
this Agreement in a form previously agreed upon by the Parties, and (iii) a general description of
the nature of the Research Program in a form previously agreed upon by the Parties. In connection
with: (w) any description of Sangamo’s intellectual property rights and drug pipeline; (x)
Sangamo’s reporting requirements under the Securities and Exchange Act of 1934, as amended, and the
Securities Act of 1933, as
27.
amended; (y) Sangamo’s fundraising activities or marketing materials; and (z) any description
or acknowledgment of JDRF or JDRF funding as required hereunder, Sangamo shall be entitled to use
and/or disclose, and JDRF hereby pre-approves Sangamo’s use and/or disclosure of: (i) the names
“JDRF,” “Juvenile Diabetes Research Foundation International”, JDRF’s logo and a general
description of JDRF in the context of describing the funding provided by JDRF, (ii) the existence
and a general description of the nature of this Agreement in a form previously agreed upon by the
Parties, and (iii) a general description of the nature of the Research Program in a form previously
agreed upon by the Parties.
ARTICLE VI PUBLICATION
Sangamo shall have the first right to publish, publicly present, or otherwise make available
the results of the Research Plan, including any data necessary for Third Parties to utilize any new
discoveries and information regarding the surrogate clinical endpoints related to the JDRF Studies
and identified by Sangamo during the Research Program (the “Surrogate Endpoint Data”). In
the event that Sangamo does not exercise its publication rights by submitting within twelve (12)
months after the Research Termination Date a manuscript for publication, JDRF shall have the right
to publish, publicly present, or otherwise make available the Surrogate Endpoint Data, but only to
the extent that such publication, presentation or availability of the data would not have an
adverse impact on any ongoing or planned development and/or commercialization of the Product. If
JDRF is the publishing party, JDRF will submit a draft of any proposed manuscript or speech to
Sangamo for comments at least sixty (60) days prior to submission for publication or oral
presentation. Sangamo shall notify JDRF in writing within thirty (30) days of receipt of such
draft whether such draft contains (a) information which Sangamo considers to be Confidential
Information under the provisions of
28.
Article V hereof , (b) information that if published would have an adverse effect on a patent
application which Sangamo intends to file, or (c) information which Sangamo reasonably believes
would be likely to have an adverse impact on the development or commercialization of the Product.
In any such notification, Sangamo shall indicate with specificity its suggestions regarding the
manner and degree to which JDRF may disclose such information. In the case of item (a) above, JDRF
shall not publish the Confidential Information of Sangamo in violation of Article V of this
Agreement. In the case of item (b) above, Sangamo may request a delay and JDRF 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 JDRF disagrees with Sangamo’s
assessment of the impact of the publication, then the program coordinator of each Party shall
attempt in good faith to reach a fair and equitable resolution of such disagreement. If the
disagreement is not resolved in this manner within fourteen (14) days of referral to the respective
program coordinators, then the decision of Sangamo as to publication of any information generated
by it, subject always to the confidentiality provisions of Article V hereof shall be final,
provided that such decision shall be exercised with reasonable regard for the interests and
rights of JDRF. The Parties agree that authorship of any publication will be determined based on
the customary standards then being applied in the relevant scientific journal. JDRF shall comply
with the foregoing publication requirements in the event that pursuant to Section 9.5, the
Interruption License becomes effective.
Notwithstanding the foregoing, (a) Sangamo intends to advance the body of general scientific
knowledge of Diabetes and its potential therapies and cures, all in a manner consistent with its
general scientific and commercial objectives in entering into this Agreement with JDRF,
29.
and (b) the Parties acknowledge that Sangamo intends to publish the results of the placebo
data from the Research Program in a major scientific peer reviewed publication as soon as
practicable, following the completion of the Research Program; provided that Sangamo shall
not be obligated to publish any information which Sangamo reasonably believes would be likely to
have an adverse impact on the development or commercialization of the Product. Sangamo shall
acknowledge the financial support of JDRF in all Research Program publications. In addition,
Sangamo agrees to make available to requesting Third Parties the Surrogate Endpoint Data without
charge but only after twelve (12) months have passed since the Research Termination Date.
ARTICLE VII INDEMNIFICATION
7.1 Indemnification by Sangamo. Sangamo shall indemnify, defend and hold harmless JDRF, its
Affiliates, and each of their respective directors, officers, committee members, volunteers,
employees, consultants, agents and representatives and their respective successors, heirs and
assigns (including, without limitation, the JDRF Designees) (each, a “JDRF 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) arising
therefrom (collectively “Losses”), to the extent that such Losses arise from:
(a) the conduct of the Research Program by Sangamo or its Affiliates or their respective
directors, officers, employees, consultants, agents, representatives, licensees, sublicensees,
subcontractors and/or investigators (each, a “Sangamo Party”) under this
30.
Agreement and/or pursuant to one or more agreements between Sangamo and any Sangamo Party, or
any actual or alleged violation of law resulting therefrom;
(b) the Product (not including any Product developed, manufactured or sold pursuant to the
Interruption License) and/or any claim of infringement or misappropriation of intellectual property
with respect thereto;
(c) Sangamo’s breach of any of its representations, warranties, covenants and/or obligations
under this Agreement, or the negligence or willful misconduct of any Sangamo Party in connection
with Sangamo’s performance of its obligations under this Agreement; or
(d) Any tort claims of personal injury (including death) arising out of, or in connection
with, Sangamo’s performance of the Research Program.
The above indemnification shall not apply to the extent that any Losses are due to the gross
negligence or willful misconduct of JDRF or the practice of the Interruption License.
7.2 Indemnification by JDRF. In the event that, pursuant to Section 9.5, the Interruption
License becomes effective, JDRF shall indemnify, defend and hold harmless Sangamo, its Affiliates,
and their respective directors, officers, employees, consultants, agents and representatives and
their respective successors, heirs and assigns (including, without limitation, the Sangamo
Designees), (each a “Sangamo Indemnitee”), from and against any and all Losses that arise
as a result of (a) practice of the Interruption License or (b) JDRF’s activities after the
Interruption License Effective Date and before the Reversion License Effective Date to the extent
that such Losses arise from JDRF’s breach of any of its obligations under this Agreement, or the
negligence or willful misconduct of JDRF in connection with JDRF’s performance of its obligations
under this Agreement.
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The above indemnification shall not apply to the extent that any Losses are due to the gross
negligence or willful misconduct of Sangamo or a Sangamo Party.
7.3 Claims Procedures. The Party claiming indemnity under this Article VII (the
“Indemnified Party”) shall give written notice to the Party from whom indemnity is being
sought (the “Indemnifying Party”) promptly after learning of the commencement of the
relevant Third Party action, suit or proceeding (the “Claim”). Subject to this Section
7.3, the Indemnifying Party shall have the right to assume and manage the defense thereof (with
counsel selected by the Indemnifying Party and reasonably satisfactory to the Indemnified Party),
including the right to settle, compromise and/or litigate with respect to any such Claim (but only
after obtaining the Indemnified Party’s prior written consent with respect to any proposed
settlement, compromise or litigation; provided, however, that the Indemnifying
Party shall not be required to obtain the Indemnified Party’s prior written consent in connection
with any proposed settlement, compromise or litigation if, in connection with and following any
such settlement, compromise or litigation, the 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 the Indemnified Party’s sole
expense, provided that, (a) the employment of counsel by the Indemnified Party has been authorized
by the Indemnified Party; or (b) there is a conflict of interest that would prevent an Indemnitee
from being represented by a single law firm in the defense of such action; in each such instance,
the Indemnifying Party shall pay the reasonable fees and expenses of one law firm
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serving as counsel for the Indemnified Party, which law firm shall be subject to the prior
consent of the Indemnifying Party, which such consent shall not be unreasonably withheld,
conditioned or delayed.
7.5 Advance Payment of Expenses. The expenses of an Indemnified Party incurred in defending a
Claim 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 Indemnified Party to repay the amount if it is ultimately determined by a court of competent
jurisdiction that such Indemnified Party is not entitled to be indemnified by the Indemnifying
Party. All costs and expenses incurred by an Indemnified Party in connection with enforcement of
this Article VII also shall be reimbursed by the Indemnifying Party.
7.6 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY
SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR EXEMPLARY DAMAGES, INCLUDING, BUT NOT
LIMITED TO, LOST PROFITS, IN CONNECTION WITH SUCH PARTY’S PERFORMANCE OR BREACH OF THIS AGREEMENT.
NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 7.6 IS INTENDED TO OR SHALL LIMIT OR
RESTRICT THE INDEMNIFICATION RIGHTS OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF CONFIDENTIALITY
OBLIGATIONS IN ARTICLE V.
7.7 Insurance. Sangamo shall maintain at its own expense, with a reputable insurance carrier
reasonably acceptable to JDRF, full coverage for Sangamo, its Affiliates, and their respective
employees that is commensurate with a reasonable estimate of the liability exposure associated with
the Research Program, written on a per occurrence basis, which will name JDRF as an additional
insured, including, without limitation, errors and omissions
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insurance encompassing claims relating to the performance and lack of performance of Sangamo’s
obligations under this Agreement and comprehensive general liability insurance for claims relating
to the performance and lack of performance of Sangamo’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 a Sangamo Party which
will be specifically endorsed to cover Sangamo’s indemnification obligations under this Article
VII. Maintenance of such insurance coverage will not relieve Sangamo of any responsibility under
this Agreement for damage in excess of insurance limits or otherwise. On or prior to the Effective
Date, Sangamo shall provide JDRF with an insurance certificate from insurer(s) evidencing each
insurance coverage and the insurer’s agreement to notify JDRF at least sixty (60) days in advance
of any cancellation or modification of such insurance coverage.
In the event that the Interruption License becomes effective pursuant to Section 9.5, JDRF
shall comply with the foregoing insurance requirements and shall maintain such insurance for as
long as necessary to cover any claims that may arise from JDRF’s activities during the
effectiveness of the Interruption License.
ARTICLE VIII PATENTABLE INVENTIONS
8.1 Ownership. All inventions made and all data and know-how generated solely by either Party
or its Affiliates (directly or through others acting on its behalf), as determined in accordance
with United States laws of inventorship, prior to and during the term of this Agreement that
relates to the Research Program shall be solely owned by the Party making the invention or
generating the data or know-how, and all Patents claiming such inventions shall be
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solely owned by such Party. All inventions made and all data and know-how generated by both
Parties jointly, as determined in accordance with United States laws of inventorship, prior to and
during the term of this Agreement that relate to the Research Program (a “Joint
Invention”), shall be owned jointly, with each Party having an undivided one-half interest in
each Joint Invention and each Patent claiming a Joint Invention.
8.2 Preparation. Sangamo shall take initial responsibility for the preparation, filing,
prosecution and maintenance of all Sangamo Patents, JDRF Patents, and any patents and patent
applications claiming Joint Inventions. JDRF shall have the right to review, and Sangamo shall
deliver to JDRF, all patent applications for JDRF Patents or claiming Joint Inventions prior to
their filing. With respect to such patent applications, Sangamo shall include in the Quarterly
Reports delivered to JDRF pursuant to Section 3.2.3(a) the name of each patent application filed by
Sangamo in the United States and other jurisdictions for such Joint Inventions and/or JDRF Patents,
along with a general summary of the claims made and the jurisdictions of filing.
8.3 Costs. Subject to Section 8.4, Sangamo shall be responsible for all costs incurred in
the preparation, prosecution and maintenance of Sangamo Patents, JDRF Patents, and Joint
Inventions.
8.4 Abandonment.
(a) Notwithstanding any contrary provision contained herein, prior to the Interruption License
Effective Date, before Sangamo (or any Affiliate, licensee, sublicensee, transferee or successor of
Sangamo) abandons any patent or patent application for any JDRF Patents or claiming any Joint
Inventions (including abandonment for failure to pay any required fees), Sangamo shall promptly
notify JDRF, or cause JDRF to be notified, of such pending abandonment, whereupon JDRF shall have
the right and opportunity to take title to such patent
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and/or patent application by agreeing to maintain the issued patent or continue prosecution of the
patent application at JDRF’s own expense.
(b) Following the Interruption License Effective Date, before Sangamo (or any Affiliate,
licensee, sublicensee, transferee or successor of Sangamo) abandons any patent or patent
application for any JDRF Patents, claiming any Joint Inventions, or for any Sangamo Patents
(including abandonment for failure to pay any required fees), Sangamo shall promptly notify JDRF,
or cause JDRF to be notified, of such pending abandonment, whereupon JDRF shall have the right and
opportunity to take title to such patent and/or patent application by agreeing to maintain the
issued patent or continue prosecution of the patent application at JDRF’s own expense. Sangamo
shall reasonably cooperate with JDRF to obtain such consents, on JDRF’s behalf, as may be
necessary, advisable and/or appropriate for JDRF to exercise its rights under this Section 8.4.
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 such time as
when there are no longer any payment obligations owing from either Party to the other Party under
Article IV hereto.
9.2 Termination by JDRF With Cause. Notwithstanding any provision contained herein, JDRF may,
without prejudice to any other remedies available to it at law or in equity, terminate this
Agreement if, after the occurrence of a Default (as defined herein) and Sangamo’s receipt of a
written notice from JDRF identifying such Default, Sangamo fails to cure such
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Default within sixty (60) days after Sangamo’s receipt of such notice. The following events
shall constitute a “Default” hereunder:
(a) Any material breach by Sangamo of any applicable foreign, federal, state or local laws,
statutes, rules or regulations in the course of its performance of the Research Program;
(b) Any material breach or default by Sangamo in the performance of any of its material
covenants or obligations hereunder;
(c) Any representation or warranty made by Sangamo in this Agreement is not true in any
material respects as of the Effective Date; and/or
(d) A case or proceeding (i) under the bankruptcy laws of the United States now or hereafter
in effect is filed against Sangamo or all or substantially all of its assets and such petition or
application is not dismissed within sixty (60) days after the date of its filing or Sangamo 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 is filed by Sangamo for all or substantially all of
its assets.
For clarity, an Interruption shall not, for the purposes of this Section 9.2, be considered a
material breach or default by Sangamo in the performance of any of its material covenants or
obligations hereunder. JDRF’s remedies in the event of an Interruption are set forth in Section
9.5 rather than in this Section 9.2.
9.3 Termination for JDRF Breach. Sangamo may, without prejudice to any other remedies
available to it at law or in equity, terminate this Agreement upon written notice to JDRF in the
event JDRF shall have materially breached or defaulted in the performance of any of
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its material covenants or obligations hereunder, and JDRF fails to cure such breach or default
within sixty (60) days after written notice thereof was provided to JDRF by Sangamo.
9.4 General Effect of Termination; Survival.
(a) Termination, relinquishment 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, relinquishment or expiration. Such termination, relinquishment or expiration shall
not relieve any Party from obligations 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 3.2.1, 3.2.2, 3.2.3(b), and 9.4, Articles V,
VI, VII, VIII, and XI shall survive expiration, termination or relinquishment of this Agreement.
If this Agreement is terminated pursuant to Section 9.2 and no Interruption License is in effect at
the time of such termination, in addition to the provisions specified in the preceding sentence,
the Parties’ rights and obligations under, and/or provisions contained in Sections 4.2, 4.3, 4.4
and 9.5 shall also survive such termination. In the event that, pursuant to Section 9.5, the
Interruption License becomes effective prior to termination of this Agreement pursuant to Sections
9.1 or 9.2, in addition to the provisions specified in the first sentence of this Section 9.4(b),
the Parties’ rights and obligations under, and/or provisions contained in Sections 4.4, 9.5(e),
9.5(g) and 9.5(h) shall survive such termination.
(c) Sangamo will retain sole ownership of the Sangamo Research Program Technology.
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9.5 Interruption License.
(a) In the event JDRF determines that an Interruption has occurred, it shall notify Sangamo in
writing of such belief, stating in reasonable detail the basis for its belief that an Interruption
has occurred (the “Interruption Notice”). If at the time of receipt of the Interruption
Notice, Sangamo (i) has not licensed or otherwise transferred rights to a Third Party to the
Sangamo Research Program Technology in the Field; or (ii) has successfully terminated the rights it
licensed or otherwise transferred to a Third Party to the Sangamo Research Program Technology in
the Field, then Sangamo shall have sixty (60) days after the receipt of the Interruption Notice to
avoid the Interruption License Effective Date by (x) responding to the Interruption Notice by
explaining why it believes an Interruption has not occurred (the “Interruption Response”);
or (y) resuming Commercially Reasonable Efforts (either itself or through an Affiliate,
collaborator, licensee, sublicensee, transferee, or successor); provided that, Sangamo may avoid
the Interruption License Effective Date by any such resumption only once.
(b) If at the time of receipt of the Interruption Notice, Sangamo has licensed or otherwise
transferred rights to a Third Party to the Sangamo Research Program Technology in the Field
pursuant to an agreement that includes a provision that gives Sangamo the right to terminate such
Third Party’s rights under the Sangamo Research Program Technology in the Field upon a final
determination that an Interruption has occurred and not been cured within the applicable time after
the relevant notice, then Sangamo shall have sixty (60) days after the receipt of the Interruption
Notice to avoid the Interruption License Effective Date by (i) providing an Interruption Response
to JDRF; or (ii) commencing and continuing thereafter commercially reasonable efforts to effect
such a termination. If Sangamo successfully effects such a termination then it shall have sixty
(60) days after the termination effective date to avoid
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the Interruption License Effective Date by resuming Commercially Reasonable Efforts (either
itself or through an Affiliate, collaborator, licensee, sublicensee, transferee, or successor);
provided that, Sangamo may avoid the Interruption License Effective Date by any such resumption
only once.
(c) If Sangamo provides an Interruption Response within the sixty (60) day period set forth in
Section 9.5(a) or 9.5(b) and JDRF disagrees with the Interruption Response, JDRF may resolve such
Dispute in accordance with Section 11.2. Sangamo shall have sixty (60) days after a final
determination pursuant to Section 11.2 that an Interruption has occurred (or if earlier a
subsequent written admission by Sangamo that an Interruption has occurred) to avoid the
Interruption License Effective Date by (i) resuming Commercially Reasonable Efforts (either itself
or through an Affiliate, collaborator, licensee, sublicensee, transferee, or successor); provided
that, Sangamo may avoid the Interruption License Effective Date by any such resumption only once;
or (ii) if Sangamo provided the Interruption Response pursuant Section 9.5(b), commencing and
continuing thereafter commercially reasonable efforts to terminate such Third Party’s rights under
the Sangamo Research Program Technology in the Field upon a final determination that an
Interruption has occurred and not been cured within the applicable time after the relevant notice.
If Sangamo successfully effects such a termination then it shall have sixty (60) days after the
termination effective date to avoid the Interruption License Effective Date by resuming
Commercially Reasonable Efforts (either itself or through an Affiliate, collaborator, licensee,
sublicensee, transferee, or successor); provided that, Sangamo may avoid the Interruption License
Effective Date by any such resumption only once.
(d) The “Interruption License Effective Date” shall be the first of the following
events to occur: (i) the expiration of the sixty (60) day period set forth in Section
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9.5(a) without Sangamo having taken any of the actions specified in Section 9.5(a), (ii)
Sangamo’s agreement in writing, following receipt of the Interruption Notice, that an Interruption
has occurred (provided, however, that none of Sangamo’s written communications pursuant to Section
9.5(b)(ii) or 9.5(c)(ii) shall be considered such an agreement), (iii) the expiration of the
applicable sixty (60) day period set forth in Section 9.5(b) without Sangamo having taken any of
the actions specified in Section 9.5(b), or (iv) the expiration of the applicable sixty (60) day
period set forth in Section 9.5(c) without Sangamo having taken any of the actions specified in
Section 9.5(c).
(e) Upon the Interruption License Effective Date, Sangamo shall be deemed to have
automatically granted to JDRF with respect to the Research Program an exclusive (even as to
Sangamo) worldwide license, with the right to sublicense, under the Sangamo Research Program
Technology, to manufacture, have manufactured, sell, offer to sell and import the Product in the
Field (the “Interruption License”). Sangamo’s obligations pursuant to Sections 3.2.3(d),
4.1 and 4.2 shall expire upon the Interruption License Effective Date.
(f) For clarity, prior to the Interruption License Effective Date, Sangamo shall be free to
license to a Third Party the Sangamo Research Program Technology (including the grant of exclusive
worldwide sublicensable rights under Sangamo Research Program Technology for such Third Party to
research, develop, or commercialize the Product). In the event that Sangamo commences negotiations
with a Third Party to transfer all of or certain of Sangamo’s rights under the Sangamo Research
Program Technology to such Third Party to develop and commercialize a Product in the Field, Sangamo
shall use best commercial efforts to include in the agreement a provision that gives Sangamo the
right to terminate such Third Party’s rights under the Sangamo Research Program Technology in the
Field upon a final determination that an
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Interruption has occurred and not been cured within the applicable time after the relevant
notice; and solely for purposes of this Section 9.5, the term “Interruption” with respect to a
Sangamo Third Party licensee or transferee shall be defined in a manner that is as close to the
definition contained in Section 1.22 as Sangamo, by the exercise of best commercial efforts, is
able to include in the executed agreement with such Third Party. In the event that Sangamo does
not successfully negotiate such a provision, then Sangamo shall so notify JDRF prior to Sangamo’s
execution of the agreement with such Third Party and, upon receipt of such notice, JDRF shall no
longer have any right to obtain the Interruption License with respect to the Sangamo Research
Program Technology licensed or transferred to such Third Party.
(g) In connection with this Section 9.5, Sangamo shall deliver to JDRF, within sixty (60) days
of the Interruption License Effective Date, all materials and data generated in the performance of
the Research Program and the Sangamo Research Program Technology and all other materials and data
that Sangamo may Control that are reasonably required by JDRF to manufacture, have manufactured,
sell, offer to sell and import the Product in the Field, provided that the foregoing obligations
shall apply only to the extent such materials or data are reasonably accessible and available to
Sangamo.
(h) Notwithstanding the foregoing or any contrary provision contained in this Section 9.5, if,
following the Interruption License Effective Date, JDRF ceases to conduct Commercially Reasonable
Efforts with respect to the research, development and commercialization of the Product in the Field
for a period of one hundred eighty (180) consecutive days then upon the expiration of such 180-day
period (the “Reversion License Effective Date”) the Interruption License shall terminate
and, in accordance with the terms and conditions of this Agreement, JDRF shall be deemed to have
automatically granted to Sangamo a
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non-exclusive, royalty-free, fully paid, irrevocable, perpetual, worldwide license (with the
right to grant sublicenses), under the JDRF Interruption License Technology to research, develop,
make, have made, use, import, offer for sale and sell the Product in the Field. In addition, JDRF
shall deliver to Sangamo within sixty (60) days of the Reversion License Effective Date all
materials and data generated by JDRF and all other materials and data that JDRF may Control that
are reasonably required by Sangamo to manufacture, have manufactured, sell, offer to sell and
import the Product in the Field, provided that the foregoing obligations shall apply only to the
extent such materials or data are reasonably accessible and available to JDRF.
ARTICLE X REPRESENTATIONS AND WARRANTIES
10.1 Representations, Warranties and Covenants of Sangamo.
(a) As of the Effective Date, Sangamo represents and warrants to JDRF that: (i) this Agreement
has been duly executed and delivered by Sangamo and constitutes the valid and binding obligation of
Sangamo, enforceable against Sangamo 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; (ii) the
execution, delivery and performance of this Agreement have been duly authorized by all necessary
action on the part of Sangamo and its directors and stockholders; (iii) the individual executing
this Agreement on behalf of Sangamo is duly authorized to do so; and (iv) no provision contained in
this Agreement violates any other agreement to which Sangamo is bound or otherwise subject.
(b) In addition to the foregoing, as of the Effective Date, Sangamo represents, warrants and
covenants to JDRF that (i) while guaranteeing no specific results, it has the knowledge, skills,
expertise and experience to perform the Research Program or the resources to
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engage Persons to perform the Research Program who have such knowledge, skills, expertise and
experience; (ii) it has and shall maintain all licenses, permits and other approvals and
authorizations required for Sangamo to conduct work under the Research Program consistent with its
obligations pursuant to this Agreement and shall do so in conformity with all applicable laws,
statutes, rules and regulations, and the applicable policies of any and all medical research
institutions at which Sangamo is conducting work under the Research Program (collectively,
“Applicable Law”); (iii) it shall abide by and comply with all of the applicable provisions
and conditions set forth in the “JDRF Policies and Conditions Regarding Funding of Research
Involving Human Clinical Trials,” attached hereto as Exhibit C (the “Policies”),
and Sangamo hereby acknowledges that it is a “Sponsor” within the meaning of such Policies; (iv) it
shall not enter into any arrangement, understanding or agreement that conflicts in any manner with
this Agreement and Sangamo’s obligations and responsibilities hereunder; provided that the
foregoing shall not be interpreted as prohibiting Sangamo from entering into an agreement with a
Third Party whereby such Third Party would research, develop, make, have made, use, import, offer
for sale and sell the Product or participate in the Research Program; and (v) with respect to any
Third Party to whom Sangamo subcontracts the performance of any aspect of the Research Program,
Sangamo shall: (A) subcontract only with reputable entities that 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 for such subcontractor to conduct its work under the
Research Program; and (C) use Commercially Reasonable Efforts to ensure that each such
subcontractor conducts all work under the Research Program in conformity with Applicable Law.
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10.2 Representations and Warranties of JDRF. As of the Effective Date, JDRF represents and
warrants to Sangamo that: (a) this Agreement has been duly executed and delivered by JDRF and
constitutes the valid and binding obligation of JDRF, enforceable against JDRF 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 JDRF and its directors;
(c) the individual executing this Agreement on behalf of JDRF is duly authorized to do so; and (d)
no provision contained in this Agreement violates any other agreement to which JDRF is bound or
otherwise subject.
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 Delaware without regard to any conflict of laws principles thereof
that would cause the application of the laws of a different jurisdiction.
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 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, or their respective
designees, of both JDRF and Sangamo shall meet at a mutually
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agreed upon time and location for the purpose of resolving such Dispute. The Chief Executive
Officers, or their respective designees, 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 that each of
the Chief Executive Officers, or their respective designees, may be fully informed with respect to
the issues in the Dispute.
(b) In the event any Dispute is not resolved by the Chief Executive Officers, or their
respective designees, pursuant to Section 11.2(a), then the Parties shall resolve such Dispute by
final and binding arbitration. Arbitration shall be held in New York, NY, according to the
then-current JAMS’ Commercial Rules of Arbitration (“JAMS’ Rules”), 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 JAMS’ Rules. If the Parties are unable to select an arbitrator, then the
arbitrator shall be appointed in accordance with JAMS’ Rules. Any arbitrator chosen hereunder
shall have educational training and industry experience sufficient to demonstrate a reasonable
level of relevant scientific, financial, medical and biotechnology 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 one of the Proposals so submitted as
the resolution of the Dispute, 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
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with the terms of this Section 11.2(b), 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(b) will
preclude either Party from seeking equitable relief in accordance with Section 11.3 or interim or
provisional relief from a court of competent 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 there is 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, in addition
to any other remedy such Party 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.
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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. In such event Sangamo or JDRF, 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 such of its obligations
under this Agreement as it is thereby disabled from performing for so long as it is so disabled.
To the extent possible, each Party shall use reasonable efforts to minimize the duration of any
force majeure.
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; provided, however, that
either Party may assign this Agreement, without the consent of the other Party, (i) to any of its
Affiliates, if the assigning Party guarantees the full performance of its Affiliate’s obligations
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hereunder; (ii) in connection with such Party’s merger, consolidation or transfer or sale of
all or substantially all of the assets of such Party; or (iii) to any Third Party to whom Sangamo
grants an exclusive or co-exclusive license to develop the Product in the Field, provided,
that in the case of (ii) or (iii) hereunder, the successor, surviving entity, purchaser of assets,
transferee, or Third Party, as applicable, expressly assumes in writing such Party’s obligations
under this Agreement. Any purported assignment in contravention of this Section 11.7 shall, at the
option of the non-assigning Party, 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 JDRF and Sangamo. 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,
49.
certified mail (which shall be deemed received by the other Party on the fifth (5th) business
day following deposit in the mails), or by facsimile transmission, or other electronic means of
communication (which shall be deemed received when successful transmission is confirmed), 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 JDRF, at:
Xxxxxxx Xxxxx, M.D.
Executive Vice President for Research
Juvenile Diabetes Research Foundation International
000 Xxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000-0000
Tel.: (000) 000-0000
Fax: (000) 000-0000
Email: xxxxxx@xxxx.xxx
Executive Vice President for Research
Juvenile Diabetes Research Foundation International
000 Xxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000-0000
Tel.: (000) 000-0000
Fax: (000) 000-0000
Email: xxxxxx@xxxx.xxx
with a copy to:
Xxxxxxx X. Xxxxxxx, Esq.
Xxxxxxx XxXxxxxxx LLP
0000 X Xxxxxx, X.X., Xxxxx 000
Xxxxxxxxxx, X.X. 00000
Tel: (000) 000-0000
Fax: (000) 000-0000
Email: xxxxxxx.xxxxxxx@xxxxxxx.xxx
Xxxxxxx XxXxxxxxx LLP
0000 X Xxxxxx, X.X., Xxxxx 000
Xxxxxxxxxx, X.X. 00000
Tel: (000) 000-0000
Fax: (000) 000-0000
Email: xxxxxxx.xxxxxxx@xxxxxxx.xxx
if to Sangamo, at:
Sangamo BioSciences, Inc.
000 Xxxxx Xxxxxxxxx, Xxxxx X000
Xxxxxxxx, XX 00000
Attention: Chief Executive Officer
000 Xxxxx Xxxxxxxxx, Xxxxx X000
Xxxxxxxx, XX 00000
Attention: Chief Executive Officer
with a copy to:
Xxxxx Xxxxxxx, Ph.X.
Xxxxxx Godward, LLP
5 Palo Alto Square
0000 Xx Xxxxxx Xxxx
Xxxx Xxxx, XX 00000
Xxxxxx Godward, LLP
5 Palo Alto Square
0000 Xx Xxxxxx Xxxx
Xxxx Xxxx, XX 00000
50.
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.
[Remainder of Page Intentionally Left Blank.]
51.
IN WITNESS WHEREOF, the undersigned have executed this Agreement as of the date first written
above.
Sangamo BioSciences, Inc. | ||||||
By: | /S/ Xxxxxx X. Xxxxxxxx XX | |||||
Name: | Xxxxxx X. Xxxxxxxx XX | |||||
Title: | Chief Executive Officer | |||||
Juvenile Diabetes Research Foundation International | ||||||
By: | /s/ Xxxxxxx X. Xxxxx | |||||
Name: | Xxxxxxx Xxxxx, MD | |||||
Title: | Executive Vice President for Research | |||||
52.
Exhibit A
Research Plan
53.
Exhibit B
Research Funding and Milestones
I. Payment Schedule for Research Funding: Up to an aggregate amount of Three Million Dollars
($3,000,000), payable as follows:
[***]
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[***] | |
[***]
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[***] | |
[***]
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[***] | |
[***]
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[***] | |
[***]
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[***] | |
[***]
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[***]
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[***] |
II. Payments pursuant to this Exhibit B shall be paid by JDRF to Sangamo within forty-five
(45) days following JDRF’s receipt from Sangamo of a written certification setting forth Sangamo’s
achievement of the applicable Milestone unless the JRAC determines, in a meeting held within such
forty-five (45) day period, that such Milestone was not achieved. If JRAC’s vote on such matter
during such meeting is not unanimous, then JDRF shall make the applicable payment within forty-five
(45) days following resolution of such dispute in Sangamo’s favor.
*** CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
54.
Exhibit C
JDRF Policies and Conditions Regarding
Funding of Research Involving Human Clinical Trials
Funding of Research Involving Human Clinical Trials
JDRF will fund research involving human clinical trials only if the Sponsor of the trial can assure
JDRF, with a reasonable degree of certainty, that the following conditions will be met:
• | The research will be conducted in accordance with basic ethical principles as reflected in the Nuremburg Code, the World Medical Association Declaration of Helsinki and the Belmont Report; | ||
• | The research will comply with governmental regulatory requirements and guidance, as applicable; | ||
• | The research will be reviewed and approved by an institutional review board to assure that risk is minimized and reasonable in relation to anticipated benefits, that voluntary informed consent is given, and that the rights, safety and welfare of the subjects are maintained; | ||
• | The investigators will be qualified by training, education and experience to assume responsibility for the proper conduct of the trial and to comply with good clinical practices; | ||
• | A qualified physician will be responsible for all trial-related medical decisions. During and following a subject’s participation in the trial, the investigator will arrange for adequate medical care to be provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial; | ||
• | Conflicts of interest will be disclosed and appropriate action taken; | ||
• | Safety reporting, including serious adverse event reports, will be made in a timely fashion and in accordance with applicable regulatory requirements; | ||
• | The Sponsor of the trial will implement and maintain quality assurance and quality control systems with written standard operating procedures in order to conduct the trial, generate data and document compliance with the protocol, good clinical practices and applicable regulatory requirements; | ||
• | The clinical trial will be registered in a public registry acceptable to JDRF, if applicable; and | ||
• | The investigators conducting the research, the responsible institutional review board and the Sponsor will engage in ongoing compliance and review activity to promote and assure the integrity of the research. |
55.
Exhibit D
Press Release
56.