UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event
reported): March 10,
2005
NEUROMETRIX, INC.
(Exact name of registrant as specified in its
charter)
Delaware
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000-50856
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04-3308180
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(State or other
jurisdiction of
incorporation or organization)
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Commission file number
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(I.R.S. Employer
Identification No.)
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62 Fourth Avenue
Waltham, Massachusetts 02451
(Address of principal executive offices) (Zip
code)
Registrants telephone number, including area
code: (781) 890-9989
(Former name or former address, if changed
since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
o Written communications pursuant
to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to
Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01 Entry into a Material Definitive Agreement.
On March 10, 2005,
NeuroMetrix, Inc. (the Company) entered into an education and development
program agreement with Eli Lilly and Company, an Indiana corporation (Lilly),
pursuant to which the parties agreed to work together to conduct and present up
to eighty-four educational and development programs (the Programs) regarding
diabetic peripheral neuropathy (DPN) across the United States. Under the agreement, each Program will focus
on educating physicians regarding diabetic microvascular complications, DPN,
screening and diagnosis of DPN, nerve conduction studies, the Companys NC-stat
System and its application in DPN and the benefits to physicians and patients of
using the NC-stat System. The agreement
also provides for specific marketing rights for Lilly in relation to any
attendee of a Program that, within six months of attending a Program, purchases
an NC-stat System from the Company.
After the completion of 30 Programs, either party may elect to cancel
its respective participation in the remaining Programs.
Lilly will be responsible
for costs and expenses associated with the Programs arising from speaker
training, Lilly-executed physician recruitment vehicles and related materials. The Company will be solely responsible for costs
and expenses associated with the Programs related to specific recruiting costs
of the Company. The direct costs and
expenses arising from the conduct of the Programs will be shared equally by the
Company and Lilly and may not exceed $15,000 per Program unless mutually agreed
to by the parties. The initial term of
the agreement will be for 18 months and may be renewed for five one-year
successive terms upon agreement by the parties.
The agreement provides for early termination (i) by Lilly or the Company
in the event of a change of control of the Company, (ii) by either party if a
material breach by the other party has occurred and such breach is not cured
within ninety days of written notification of the breach to the breaching party
and (iii) by Lilly in the event its development of ruboxistaurin for, among
other things, DPN and/or its symptoms, is ended or delayed beyond the initial
term of the agreement or otherwise, in Lillys judgment, rendered impractical
due to product development issues. Depending
on how the agreement expires or is terminated, the parties specific marketing
rights and obligations for any attendee of a Program that, within six months of
attending a Program, purchases an NC-stat System from the Company may continue
in force until December 31, 2010.
The foregoing summary is
qualified in its entirety by reference to the copy of the education and
development program agreement, which is attached hereto as Exhibit 99.1
to this Current Report on Form 8-K and incorporated herein by reference.
Item 9.01 Financial
Statements and Exhibits.
(c) Exhibits
99.1 Education
and Development Program Agreement, dated as of March 2, 2005, by and
between NeuroMetrix, Inc. and Eli Lilly and Company.
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SIGNATURE
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be filed on its behalf by the undersigned hereunto duly
authorized.
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NEUROMETRIX,
INC.
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Dated: March 16, 2005
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By:
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/s/ Shai N. Gozani,
M.D., Ph.D.
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Shai N.
Gozani, M.D., Ph.D.
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President
and Chief Executive Officer
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EXHIBIT INDEX
Exhibit No. |
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Description |
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99.1
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Education and
Development Program Agreement, dated as of March 2, 2005, by and between
NeuroMetrix, Inc. and Eli Lilly and Company.
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Exhibit 99.1
EDUCATION AND DEVELOPMENT PROGRAM AGREEMENT
THIS
MARKETING PROGRAM AGREEMENT (this Agreement) made this 2nd day of
March, 2005 (Effective Date) by and between NEUROMetrix, Inc., a
Delaware corporation (NEUROMetrix), and Eli Lilly and Company, an
Indiana corporation (Lilly).
WHEREAS,
Lilly is developing a pharmaceutical product for, among other things, diabetic
peripheral neuropathy (DPN) and / or its symptoms;
WHEREAS,
NEUROMetrix has developed and is selling a neuropathy diagnostic system, and
will continue to develop and sell improvements and upgrades
thereto (collectively, the NC-stat System), as a diagnostic
for, among other things, DPN; and
WHEREAS,
the parties desire to establish and operate an education and development program
in accordance with the terms and conditions of this Agreement to achieve the
following goals: (1) increase understanding of the DPN disease state and
diagnostic testing in the DPN market; (2) establish the NC-stat System as
a leading diagnostic for DPN; (3) build the installed base of NEUROMetrix
customers as part of a data sharing arrangement; and (4) provide to Lilly
certain information regarding DPN and its diagnosis by physicians.
NOW
THEREFORE, the parties hereby agree as follows:
1. Marketing and Information Programs.
1.1. DPN Programs. Subject to the terms and conditions of this
Agreement (including Section 1.3), each of NEUROMetrix and Lilly shall
conduct by the end of the Initial Term eighty-four (84), and by mutual
agreement of the parties more, Diabetic Peripheral Neuropathy Peer-to-Peer
Programs (each such program, a DPN Program), subject to a mutual
review upon completion of thirty (30) of such programs as provided in
Section 1.4. The parties shall
define the content of the DPN Programs, with approximately fifty
percent (50%) of each DPN Program focused on diabetic microvascular
complications and DPN, and approximately fifty percent (50%) focused on
screening and diagnosis of DPN, nerve conduction studies, the NC-stat Systems
application in DPN and the benefits of using the NC-stat System. The content of
all DPN Programs shall be subject to the approval of both Lilly and
NEUROMetrix. Lilly and NEUROMetrix shall
mutually select speakers for the DPN Programs.
Lilly and NEUROMetrix shall use commercially reasonable efforts to
promote the DPN Programs by among other things employing a number of physician
recruitment vehicles. Either party may
subcontract its work obligations concerning the DPN Programs hereunder with the
written consent of the other party, which approval shall not to be unreasonably
withheld.
1.2. Compliance with Law. Each party shall conduct all its activities
hereunder in accordance with all applicable law and regulations, including
those of the United States Food and Drug Administration (FDA), those
issued by the Office of Inspector General of the United States Department of
Health and Human Services, the Health Insurance Portability and Accountability
Act, the PhRMA Code on Interactions with Healthcare Professionals and the AMA
Ethical Guidelines. In addition, all
Lilly activities shall be within Lilly corporate guidelines, including good
promotional practices and consumer privacy requirements. No party shall be obligated to conduct any
activities by the terms of this Agreement that are in violation of the
foregoing, and in no event shall Lilly obtain from NEUROMetrix, or shall
NEUROMetrix be obligated to provide, any patient-identifiable data.
1.3. Allocation of DPN Program Costs and Expenses. Lilly shall be responsible for costs and
expenses associated with the DPN Programs that include the following areas: all
those arising from speaker training, Lilly-executed physician recruitment
vehicles, and materials (the Lilly Sole Costs). NEUROMetrix shall be solely responsible for
NEUROMetrixs costs and expenses associated with the
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DPN
Programs that include NEUROMetrix specific recruiting costs. All direct costs
and expenses arising from the conduct of the DPN Programs shall be shared
equally by NEUROMetrix and Lilly, which costs shall include site costs, costs
for reproducing attendee binders and honorariums paid; provided that
NEUROMetrix shall be solely responsible for all costs and expenses of
NEUROMetrix-only materials distributed at the DPN Programs, and Lilly shall be
solely responsible for all costs and expenses of Lilly-only materials
distributed at the DPN Programs; and provided further, that the aggregate
direct costs to be shared equally by Lilly and NEUROMetrix for each DPN Program
as provided by this sentence shall not exceed $15,000 and as a result neither
party shall seek reimbursement from the other in excess of $7500 for any
particular DPN Program absent a mutually signed agreement prior to initiating
the development or execution of the program.
Each party shall reimburse the other party for all costs and expenses as
required by the terms hereof within sixty (60) days of receipt of a
reasonably detailed invoice therefor without any set-off or other deduction
thereto, save for any good faith disputes concerning amounts owed.
1.4. 30-DPN Program Termination. The parties shall complete thirty (30)
DPN Programs by February 28, 2006. After
the date on which thirty (30) DPN Programs have been completed, the parties
shall meet and review the success of the DPN Programs based on, among other
factors, their business impact, attendance, and the number of NEUROMetrix DPN
Accounts (as defined below). Either
party may, by written notice to the other within sixty (60) days of such
date, elect to cancel the remaining DPN Programs (a 30-DPN Program
Termination). As part of such
review, the parties may mutually agree in writing during such 60-day period to
modify the format and quantity of the future DPN Programs. This Agreement, including but not limited to
the DPN Data Rights, shall remain in effect with respect to the DPN Programs
already completed, subject to the terms described in Sections 2 and 6.
1.5. Project Managers and Operating Plan. Each party shall designate a project manager,
who initially for NEUROMetrix shall be Gary Gregory and for Lilly, Matt
Hedrick. The parties shall meet in
person at least once each calendar quarter during the Term (as defined below),
which meetings shall alternate between Boston and Indianapolis. At the first meeting, the parties shall
author and approve an Operating Plan, which shall define clear,
quantifiable deliverables and obligations for each party regarding the DPN
Programs, and thereafter the Operating Plan shall be revised, updated and
extended as the parties may mutually agree.
If the Initial Term (as defined below) is extended by the parties
pursuant to Section 6.1, then the parties shall extend and update the Operating
Plan for each subsequent year of the Term within sixty (60) days of the
end of the prior Term.
2. NEUROMetrix DPN Accounts.
2.1. New Accounts.
NEUROMetrix may contact the attendees of the DPN Programs using
information collected from them to market and sell the NC-stat System. Subject to the terms and conditions of this
Agreement, a physician who purchases a NC-stat System within six (6)
months of attending a DPN Program shall be treated as a NEUROMetrix DPN
Account hereunder. Any physician who is
a NEUROMetrix DPN Account hereunder may elect to opt-out at any time, whereupon
such physician will no longer be treated as a NEUROMetrix DPN Account
hereunder.
2.2. DPN Data Rights. For the NEUROMetrix DPN Accounts (but no
other customers of NEUROMetrix), from the Effective Date until December 31,
2010, Lilly shall have the following rights (collectively, the DPN
Data Rights) unless terminated as provided in Section 6.5(b):
(a) Market
Faxes. NEUROMetrix shall
send no less than two (2) promotional-educational faxes/emails (Market
Faxes) each year to each NEUROMetrix DPN Account. These communications can
occur pre-launch, day 1 of launch or post-launch of ruboxistaurin in the U.S.
The format and layout of the Lilly portion of the Market Faxes shall generally
reflect first page disease or product content and second page package insert
content as necessary. The content of the Market Faxes shall be mutually
developed by the parties, subject to NEUROMetrixs and Lillys approval, which
approval shall not be unreasonably withheld.
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(b) Account
Faxes. After the date on
which the FDA approves the New Drug Application for marketing approval of
ruboxistaurin with an indication relevant to symptoms of DPN or DPN in the
United States (the Approval Date), Lilly shall have the right to
include two (2) pages of content in all faxes sent to DPN NEUROMetrix Accounts
by NEUROMetrix in response to a patient test for DPN using the NC-stat System
(the Account Faxes). The format and layout of the Lilly portion
of the Account Faxes shall generally reflect first page disease or product
content and second page package insert content as necessary. Such pages shall
be developed by Lilly and shall be subject to NEUROMetrixs and Lillys
approval, which approval shall not be unreasonably withheld.
(c) Market
Information. NEUROMetrix
shall provide to Lilly to the extent available the following information
regarding each NEUROMetrix DPN Account: (1) the name, address and
telephone number of the account physician (Demographic Information),
and (2) certain diagnostic data generated by the use of the NC-stat System
by such physician (Diagnostic Information and together with the
Demographic Information, Market Information), which Diagnostic
Information shall be solely owned by NEUROMetrix and aggregated at the
physician practice level for disclosure to Lilly. The parties shall mutually define and
mutually agree on the Diagnostic Information to be provided to Lilly quarterly
hereunder and the permitted uses by Lilly of the Diagnostic Information.
2.3. Early Termination of DPN Data Rights. NEUROMetrixs obligation to provide to Lilly
the DPN Data Rights under Section 2.2 shall immediately terminate in full
at NEUROMetrixs option, effective upon written notice from NEUROMetrix to
Lilly, if (i) as of the 30-DPN Program Termination, there was
(1) less than an average of at least 10.0 physician attendees for all
completed DPN Programs, or (2) fewer than sixty (60) NEUROMetrix DPN
Accounts, or (ii) upon the end of the Initial Term, there was either
(1) less than an average of at least 10.0 physician attendees for all
completed DPN Programs, or (2) fewer than one hundred and
twenty-five (125) NEUROMetrix DPN Accounts.
2.4. Performance Criteria. If at any time during which Lilly has the DPN
Data Rights hereunder, either (1) less than twenty-five percent (25%)
of the accounts who would otherwise be NEUROMetrix DPN Accounts hereunder are
treated as such, or (2) more than twenty-five percent (25%) of the NEUROMetrix
DPN Accounts do not permit delivery to them of the Account Faxes, then:
(a) if at such time at least thirty (30) DPN
Programs but less than eighty-four (84) DPN Programs have been completed,
NEUROMetrix shall reimburse Lilly for fifty percent (50%) of the Lilly
Sole Costs attributable to such completed DPN Programs upon receipt from Lilly
of a reasonably detailed invoice therefor, which reimbursement amount by
NEUROMetrix shall not exceed One Hundred and Fifty Thousand Dollars ($150,000),
or, without duplication,
(b) if at such time at least eighty-four (84)
or more DPN Programs have been completed, NEUROMetrix shall reimburse Lilly for
seventy percent (70%) of the Lilly Sole Costs attributable to such completed
DPN Programs upon receipt from Lilly of a reasonably detailed invoice therefor,
which reimbursement amount by NEUROMetrix shall not exceed Two Hundred Thousand
Dollars ($200,000);
provided that the total amount reimbursed by NEUROMetrix to Lilly
pursuant to this Section 2.4 at such time shall be reduced by thirty-three
percent (33%) for each 12-month period that has elapsed since the Approval
Date, such that three (3) years after the Approval Date NEUROMetrix shall
not thereafter have any reimbursement obligations under this Section 2.4.
2.5. Lilly Audit Rights. For as long as Lilly shall have the right to
receive the DPN Data Rights hereunder, Lilly shall have the right directly or
indirectly via by an independent auditor reasonably acceptable to NEUROMetrix,
to access NEUROMetrixs records upon reasonable notice and at reasonable times
to verify the number of NEUROMetrix customer accounts deemed NEUROMetrix DPN
Accounts by NEUROMetrix during the preceding 12-month period, but this right
may not be exercised by Lilly more than once in any 12-month period and any
such auditor shall agree in writing to be subject to the confidentiality
restrictions contained herein to the same extent as Lilly. If such auditor concludes in
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good
faith, or if Lilly concludes after consultation with and the reasonable
agreement of NEUROMetrix, that such number is incorrect, all affected customer
accounts shall thereafter be correctly designated as a NEUROMetrix DPN Account
or not. Lillys expenses incurred for
such audit shall be paid by Lilly unless the audit discloses that the
difference in the reported number of NEUROMetrix DPN Accounts and the actual
NEUROMetrix DPN Accounts over the audited 12-month period is the greater of
either (i) ten (10), or (ii) five percent (5%) of the
latter number, in which case NEUROMetrix shall pay Lillys reasonable
out-of-pocket expenses for such audit not in excess of $15,000.
3. DPN Program Materials and Exclusivity.
3.1. DPN Program Materials. With respect to all Program Materials (as
defined below) created specifically for the development and performance of the
DPN Programs (collectively, the DPN Program Materials), each
party shall be the sole owner of all DPN Program Materials that relate solely
to such partys products and business, and the parties shall each own a joint
and undivided share of all other DPN Program Materials;
provided that notwithstanding anything contained herein to the contrary, all
DPN Program Materials that constitute any improvement, addition or modification
to the NC-stat System or its use shall be solely owned by NEUROMetrix and all
DPN Program Materials that constitute any improvement, addition or modification
to any Lilly product or program shall be solely owned by Lilly. Materials developed for
application to other promotional programs or uses by Lilly or NEUROMetrix are
not considered Program Materials, yet may be used in the DPN Programs as
mutually agreed upon by both Lilly and NEUROMetrix prior to their inclusion in
the DPN Programs. Program Materials shall mean all writings,
inventions, ideas and other technology, and all proprietary rights arising
therefrom. Each party shall have the
right during the Term (but not thereafter) to use DPN Program Materials, and
other materials provided to such party by the other party hereunder, for the
development, promotion and performance of the DPN Programs and as otherwise
expressly permitted by this Agreement (collectively, the Permitted
Purposes). Neither party shall use
any materials provided by the other party or DPN Program Materials except for
the Permitted Purposes, provided that either party may use during and after the
Term any of its solely owned DPN Program Materials without restriction.
3.2. Trademarks.
Neither party shall use the other partys trademarks except as approved
by the other party in connection with the DPN Program Materials. Specifications for use of a partys
trademarks may be provided by such party to the other party from time to
time. All rights in the trademarks,
their registrations, applications for such registrations, and all goodwill
associated therewith, shall remain at all times the sole property of the owning
entity, and all use of such trademarks shall inure solely to the benefit of the
owning entity.
3.3. No Royalty Obligations. Neither party shall have any obligation to
pay the other party any royalties on its sales of products or services.
3.4. Exclusivity. During the Term (but not thereafter),
NEUROMetrix agrees not to enter into any agreement with a pharmaceutical company
other than Lilly to market to physicians (i) in the Primary Target Market
or (ii) in the Secondary Target Market in the Field; provided that the
foregoing shall not
preclude NEUROMetrix from:
(a) directly or indirectly marketing or
selling products or services to any physician or other person or entity in any
field or market not in connection with an agreement with a pharmaceutical
company;
(b) directly or indirectly marketing or selling products or
services as part of an agreement with a pharmaceutical company to a physician
not part of the Primary Target Market or Secondary Target Market, but who is
part of practice group that includes one or more physicians who are in either
of those target markets; or
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(c) entering into an agreement with a
pharmaceutical company providing for or effecting a Change of Control (as
defined below), no matter the nature or purpose of that event, with the
consequence set forth in Section 6.3.
For purposes of this Section 3.4, Field shall mean pharmacologic/pharmaceutical treatment
of diabetes and DPN, including painful diabetic neuropathy, Primary Target
Market shall mean physicians who define themselves as primarily
endocrinologists or diabetologists, and Secondary Target Market shall
mean all physicians other than those within the Primary Target Market.
4. Confidentiality.
4.1. Defined.
Confidential Information of a party shall mean all information
and any tangible embodiments thereof provided by or on behalf of such party to
the other party either in connection with the negotiations pertaining to this
Agreement or in the course of performing this Agreement, including: solely
owned DPN Program Materials; marketing and business plans; customers lists; and
financial and personnel matters relating to the disclosing party or to its
present or future devices, products, sales, suppliers, customers, employees,
agents, investors or business but excluding the actual terms of this Agreement. Market Information, with the exception of the
Demographic Information, shall be treated as NEUROMetrix Confidential
Information hereunder. Demographic Information shall be Confidential
Information of both parties and usable by them without restriction.
4.2. General Obligations. During the Term of this Agreement and
thereafter, the parties agree that each party shall hold in confidence and
shall not disclose, directly or indirectly, to any third party (other than
their directors, employees, legal counsel, consultants, subcontractors, auditors
and advisors who are bound by confidentiality obligations no less restrictive
than those set forth herein) any Confidential Information of the other party,
except to the extent it is reasonably necessary or appropriate for a party to
perform a Permitted Purpose or otherwise to fulfill its obligations or exercise
its rights hereunder. During the Term
and thereafter, each party shall not use for any purpose, directly or
indirectly, Confidential Information of the other party, except for a Permitted
Purpose or otherwise to fulfill its obligations or exercise its rights
hereunder.
4.3. Exceptions.
Notwithstanding any provisions contained herein concerning
non-disclosure and non-use of the Confidential Information, the obligations of
Section 4.2 shall not apply to any portion of the Confidential Information
that the receiving party can demonstrate by legally sufficient evidence:
(i) now or hereafter, through no act or failure to act on the part of the
receiving party, becomes generally known; (ii) is known to the receiving
party at the time of receiving such Confidential Information without an
obligation of confidentiality; (iii) is hereafter furnished to the
receiving party by a third party as a matter of right without restriction on
disclosure; (iv) is independently developed by the receiving party without
use of any Confidential Information of the other party and without breach of
any provision of this Agreement; (v) is disclosed by a party to government
or other regulatory authorities to the extent that such disclosure is necessary
to protect and enforce DPN Program Materials; (vi) is disclosed in
response to a valid order of a court or other governmental body or any
political subdivision thereof; or (vii) to prosecute or defend litigation
or to comply with applicable law
and regulations, provided that with respect to clauses (vi) and (vii)
the disclosing party shall limit the scope of any disclosure as much as
reasonably possible and, except where impracticable for
necessary disclosures, request
that the Confidential Information so disclosed be held confidential by the
receiving authority to the greatest extent possible.
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4.4. Publicity and Terms of this Agreement. The parties agree that the
public announcement of the execution of this Agreement shall be in the form of
a NEUROMetrix press release similar to the press release attached, as Exhibit
A. NEUROMetrix shall distribute this NEUROMetrix press release publicly within
four (4) business days of the Effective Date. Lilly understands and agrees that NEUROMetrix shall submit a
copy of this Agreement to the United States Securities and Exchange Commission.
4.5. Termination.
Each party shall, upon the termination or expiration of this Agreement,
immediately discontinue use of the others Confidential Information, and within
ninety (90) days thereafter, all materials containing such Confidential
Information shall be returned by the receiving party or destroyed with the
disclosing partys consent.
5. Indemnification; DISCLAIMERS.
5.1. Indemnification.
(a) Indemnification
by NEUROMetrix.
NEUROMetrix shall indemnify and hold Lilly and its employees, officers,
directors and agents (collectively, Lilly Indemnitees) harmless
against any loss, damages, action, suit, claim, demand, liability, expense,
bodily injury, death or property damage (a Loss), but only to the
extent based on or arising from a claim made by a third party not affiliated
with Lilly, to the extent such Loss is based on or arises out of (i) the
breach by NEUROMetrix of any of its covenants, representations or warranties
set forth in this Agreement, or (ii) the use of any Market Information by
or on behalf of NEUROMetrix, or any actual or alleged violation of any law or
regulation resulting therefrom, or (iii) the gross negligence or
willful misconduct of NEUROMetrix or any of the other NEUROMetrix Indemnitees,
or (iv) a NEUROMetrix product or service, except in each of the foregoing
clauses (i) to (iv) for those Losses for which Lilly has an
obligation to indemnify NEUROMetrix Indemnitees pursuant to
Section 5.1(b), as to which Losses each party shall indemnify the others
Indemnitees to the extent of their respective liability for the Losses.
(b) Indemnification
by Lilly. Lilly shall indemnify
and hold NEUROMetrix and its employees, officers, directors and agents
(collectively, NEUROMetrix Indemnitees), harmless against any Loss,
but only to the extent based on or arising from a claim made by a third party
not affiliated with NEUROMetrix, to the extent such Loss is based on or arises
out of (i) the breach by Lilly of any of its covenants, representations or
warranties set forth in this Agreement, (ii) the use of any Market
Information by or on behalf of Lilly, or any actual or alleged violation of any
law or regulation resulting therefrom, or (iii) a Lilly product or
service, or (iv) the gross negligence or willful misconduct of Lilly or any of
the other Lilly Indemnitees, except in each of the foregoing clauses (i)
to (iv) for those Losses for which NEUROMetrix has an obligation to
indemnify Lilly Indemnitees pursuant to Section 5.1(a), as to which Losses
each party shall indemnify the others Indemnitees to the extent of their
respective liability for the Losses.
(c) Claims
Procedures. Each party
(the Indemnified Party), on behalf of itself and its respective
co-Indemnitees, shall give notice to the other party (an Indemnifying Party)
promptly after such Indemnified Party has actual knowledge of any threatened or
asserted claim as to which indemnity may be sought under Section 5.1(a) or
5.1(b), and shall permit the Indemnifying Party to assume the defense of any
such claim, provided: (i) that counsel for the Indemnifying Party who
shall conduct the defense of such claim shall be approved by the Indemnified
Party (which approval shall not be unreasonably withheld) and the Indemnified
Party may participate in such defense at such Indemnified Partys expense; and
(ii) the failure of any Indemnified Party to give notice as provided herein
shall not relieve the Indemnifying Party of its obligations under this
Agreement to the extent that the failure to give notice did not result in harm
to the Indemnifying Party. No
Indemnifying Party, in the defense of any such claim shall consent to entry of
any judgment or enter into any settlement which (1) would result in
injunctive or other non-monetary relief of any kind being imposed against the
Indemnified Party or its co-Indemnitees, or (2) does not include as an
unconditional term thereof the giving by the claimant or plaintiff to the
Indemnified Party and its co-Indemnitees of a release from all liability in
respect to such
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claim. Each Indemnified Party shall furnish such
information regarding itself, its co-Indemnitees and the claim in question as
an Indemnifying Party may reasonably request in writing.
5.2. DISCLAIMERS.
EXCEPT
AS EXPRESSLY PROVIDED HEREIN, NEITHER OF THE PARTIES MAKES ANY REPRESENTATIONS
OR WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, AND EXPRESSLY DISCLAIMS
ANY AND ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING ALL WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NONINFRINGEMENT.
EXCEPT
FOR THE PARTIES INDEMNIFICATION OBLIGATIONS CONTAINED IN SECTION 5.1,
UNDER NO CIRCUMSTANCES SHALL EITHER OF THE PARTIES BE ENTITLED TO RECOVER FROM
THE OTHER ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL, EXEMPLARY OR
PUNITIVE DAMAGES (INCLUDING DAMAGES FOR LOSS OF BUSINESS), WHETHER BASED ON CONTRACT,
TORT (INCLUDING NEGLIGENCE) OR ANY OTHER CAUSE OF ACTION, RELATING TO OR
ARISING OUT OF THE DPN PROGRAMS, THE DPN DATA RIGHTS, THE DPN PROGRAM MATERIALS
OR OTHERWISE RELATING TO OR ARISING OUT OF THIS AGREEMENT, EVEN IF A PARTY HAS
BEEN INFORMED OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES.
6. Term and Termination.
6.1. Term of this Agreement. This Agreement shall become effective as of
the Effective Date, may be terminated as set forth in this Section 6 or
elsewhere in this Agreement, and otherwise shall remain in full force and
effect for eighteen (18) months after the Effective Date (the Initial
Term), and thereafter may be extended for up to five (5) successive
one year periods upon the mutual written agreement of the parties at least
sixty (60) days before the end of the then-effective term
(the Initial Term, plus all of the successive one-year extensions,
together the Term).
6.2. Termination for Material Breach. If either party materially breaches this
Agreement at any time, which breach is not cured within ninety (90) days
of written notice thereof from the non-breaching party, the non-breaching party
may terminate this Agreement effective as the end of the cure period upon
written notice to the other party.
6.3. Termination Upon Change of Control. In the event of a Change of Control (as
defined below), NEUROMetrix or Lilly may elect both to terminate this Agreement
and to terminate all of Lillys rights to the DPN Data Rights, by notifying the
other party in writing within six (6) months of the occurrence of such
Change of Control. Further, in the event
NEUROMetrix (but not Lilly) terminates this Agreement and the DPN Rights
pursuant to this Section 6.3, then:
(a) if at the time of such notice at least
thirty (30) but less than eighty-four (84) DPN Programs have been completed,
NEUROMetrix shall reimburse Lilly for fifty percent (50%) of the Lilly
Sole Costs attributable to such completed DPN Programs within ninety (90)
days of receipt from Lilly of a reasonably detailed invoice therefor, which
reimbursement amount by NEUROMetrix shall not exceed One Hundred and Fifty
Thousand Dollars ($150,000), or, without duplication,
(b) if at the time of such notice at least
eighty-four (84) or more DPN Programs have been completed, NEUROMetrix shall
reimburse Lilly for seventy percent (70%) of the Lilly Sole Costs attributable
to such completed DPN Programs within ninety (90) days of receipt from
Lilly of a reasonably detailed invoice therefor, which reimbursement amount by
NEUROMetrix shall not exceed Two Hundred Thousand Dollars ($200,000);
provided that the total amount reimbursed by NEUROMetrix to Lilly
pursuant to this Section 6.3 at such time shall be reduced by thirty-three
percent (33%) for each 12-month period that has elapsed since the Approval
Date, such that three (3) years after the Approval Date NEUROMetrix shall
not be required to
7
pay Lilly any amounts to terminate this Agreement and Lillys rights to
the DPN Data Rights pursuant to this Section 6.3 upon a Change of
Control. The termination of this
Agreement and Lillys rights to the DPN Data Rights shall be effective upon the
earlier of (i) sixty (60) days after the terminating party sends
written notice of termination or (ii) NEUROMetrixs payment in full of the
applicable amount (if any) from above.
For purposes of this Agreement, Change of Control shall mean
the occurrence of any of the following events: (i) any person (as such
term is used in Sections 13(d) and 14(d)(2) of the Securities Exchange Act of
1934, as amended) becomes a beneficial owner (as such term is defined in Rule
13d-3 promulgated under such Act) (other than NEUROMetrix), directly or
indirectly, of securities of NEUROMetrix representing fifty percent (50%)
or more of the combined voting power of the NEUROMetrixs then outstanding
securities; (ii) the stockholders of NEUROMetrix approve a merger or
consolidation of NEUROMetrix with any other entity, other than a merger or
consolidation which would result in the voting securities of NEUROMetrix
outstanding immediately prior thereto continuing to represent (either by
remaining outstanding or by being converted into voting securities of the
surviving entity) more than fifty percent (50%) of the combined voting
power of the voting securities of NEUROMetrix or such surviving entity
outstanding immediately after such merger or consolidation; or (iii) the
stockholders of NEUROMetrix approve an agreement for the sale or disposition by
NEUROMetrix of all or substantially all of NEUROMetrixs assets or all of
NEUROMetrixs assets to which this Agreement relates.
6.4. Termination Related to Product Development. Lilly may, in its sole discretion, elect to
terminate this Agreement in the event its development of ruboxistaurin for,
among other things, diabetic peripheral neuropathy and/or its symptoms, is
ended or delayed beyond the Initial Term or otherwise, in Lillys judgment,
rendered impractical due to product development issues. Lilly can effect such a termination by
notifying NEUROMetrix in writing of the decision and the reasons therefor to
terminate no sooner than July 31st, 2005 and no later than December
31st, 2005, which December 31st date may be extended by
mutual agreement of the parties in writing.
6.5. Effects of Expiration and Termination.
(a) Termination
and Accrued Rights. All
rights, obligations and provisions of this Agreement that do not expressly
survive termination or expiration of this Agreement as provided in this
Section 6.5 shall terminate in full upon such event. Termination of this Agreement for any reason
or expiration of this Agreement shall not affect any accrued rights or
obligations of the parties as of the date of such termination or expiration.
(b) Survival
of DPN Data Rights. The
survival and continuation of the DPN Data Rights until December 31, 2010 shall
depend on various circumstances as provided below:
(i) Subject to the following clause (ii), upon expiration of this
Agreement, or upon termination of this Agreement as a result of a 30-DPN
Program Termination or by Lilly pursuant to Section 6.2 because of
NEUROMetrixs material, uncured breach, Lilly shall continue to receive the DPN
Data Rights, and thereafter Sections 2.1, 2.2 and 2.5 shall continue in
full force and effect in accordance with their respective terms until
December 31, 2010 (but not thereafter); and
(ii) NEUROMetrixs obligation to provide, and Lillys right to receive,
the DPN Data Rights shall terminate in full (1) in accordance with
Section 2.3, 6.3 or 6.4, (2) if NEUROMetrix terminates this
Agreement pursuant to Section 6.2 for Lillys material, uncured breach, or
(3) after the expiration or termination of this Agreement, if Lilly fails
to cure a material breach of any surviving provision as provided by
Section 6.2, whereupon in each case all of Sections 2.1, 2.2 and 2.5
shall terminate in full, with the exception that Demographic Information
already collected as of the termination date shall remain the Confidential
Information of both parties and shall be usable by them without restriction.
8
(c) Survival
of Other Provisions. In
addition to the provisions identified in Section 6.5(b) (if any), upon
expiration or any termination of this Agreement, the provisions of
Sections 1.2, 1.3, 3 (other than Section 3.4) and 4 to 7
shall survive and shall continue in full force and effect.
7. Miscellaneous.
7.1. Entire Agreement. This Agreement (including the Exhibits)
constitutes the entire agreement between the parties relating to the subject
matter hereof and supersedes all previous agreements, practices or courses of
dealings between the parties, whether written or oral, relating to the subject
matter hereof. In the event that there
is a conflict between the terms contained in body of this Agreement and any of
the Exhibits or the Operating Plan, the terms contained in this body shall
control.
7.2. Independent Contractors. The parties are independent contractors and
are not, and shall not represent themselves as, principal and agent, partners
or joint venturers. Neither party shall
attempt to act, or represent itself as having the power, to bind or create any
obligation on behalf of the other.
7.3. Assignment.
Subject to Section 6.3 and except as otherwise expressly provided
above, this Agreement, and the rights and obligations of the parties hereunder,
shall not be assigned or transferred, in whole or in part, by operation of law
or otherwise, by either party hereto without the prior written consent of the
other party, provided that either party shall have the right to assign this
Agreement as a whole to an affiliate, to a successor of such party to its
entire business or that part of its business to which this Agreement relates,
or to the surviving entity in a Change of Control or other merger,
recapitalization, share exchange or consolidation with such party (whether by
operation or law or otherwise), without such prior written consent, which in
the event of a Change of Control, shall give rise to the termination right set
forth in Section 6.3. Any
assignment, delegation or other transfer in violation of the foregoing shall be
null and void. This Agreement shall be
binding upon, and inure to the benefit of, the legal representatives,
successors and permitted assigns of the parties.
7.4. Severability. If any provision of this
Agreement is found invalid or unenforceable by a court of competent
jurisdiction, such provision shall be enforced to the maximum extent
permissible by law and the other provisions of this Agreement shall remain in
full force and effect.
7.5. Waivers; Amendments. No waiver by either party of a breach of any
covenant or condition of this Agreement by the other party shall be construed
to be a waiver of any succeeding breach of the same or any other covenant or
condition. This Agreement or any Exhibit
hereunder may not be modified or amended except by a writing expressly
referring to this Agreement signed by both parties.
7.6. Governing Law. This Agreement shall be governed by, and
construed and enforced in accordance with, the substantive laws of the state of
Indiana, without regard to its principles of conflicts of laws.
7.7. Notices.
All notices, demands, requests, approvals, consents or other
communications to be given or delivered under this Agreement shall be in
writing and shall be deemed to have been given (i) when delivered in
person or by courier or confirmed facsimile, or (ii) upon receipt when
sent by reputable private international courier with established tracking
capability (such as DHL, FedEx, or UPS), postage pre-paid, and addressed to the
noticed party at the address set forth below, or such other address as a party
may specify by written notice to the other.
Notices shall be sent to NEUROMetrix at:
NEUROMetrix, Inc.
|
62 Fourth Avenue
|
Waltham, MA 02451
|
Attention:
|
Shai N. Gozani, President and CEO
|
Facsimile:
|
(781) 890-1556
|
9
with a required copy to:
Goodwin Procter LLP
|
Exchange Place
|
Boston, MA 02109
|
Attention:
|
H. David Henken, P.C.
|
|
Kingsley L. Taft, Esq.
|
Facsimile:
|
(617) 523-1231
|
and to Lilly at:
Nat Osborne
|
Director, Marketing PKC ß Inhibitor Global Brand Development Team
|
Eli Lilly and Company
|
Lilly Corporate Center
|
Indianapolis, IN 46285
|
With a copy to:
Colin Ewing, Esq.
|
Associate General Counsel
|
Eli Lilly and Company
|
Lilly Corporate Center
|
Indianapolis, IN 46285
|
7.8. Captions, Section Headings. As used in this Agreement, including means including
but not limited to, and herein, hereof, and hereunder refer to this
Agreement as a whole. The Section
headings used hereof are for reference and convenience only, and shall not
enter into the interpretation of this Agreement.
[remainder of this page
intentionally left blank]
10
IN
WITNESS WHEREOF, the parties have caused this MARKETING PROGRAM AGREEMENT to be
executed under seal by their authorized representatives as of the date first
written above.
NEUROMETRIX, INC.
|
|
ELI LILLY AND COMPANY
|
|
|
|
Signature:
|
|
/s/ Gary L. Gregory
|
|
Signature:
|
|
/s/ Nat Osborne
|
|
Name:
|
|
Gary L. Gregory
|
|
Name:
|
|
Nat Osborne
|
Title:
|
|
Chief Operating Officer
|
|
Title:
|
|
Marketing Director
|
Date:
|
|
3/10/05
|
|
Date:
|
|
3/3/05
|
|
|
|
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|
|
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Exhibit A
Press Release
NeuroMetrix Announces Strategic Relationship
with Eli Lilly and Company to Improve Awareness and Detection of Serious
Complication of Diabetes
WALTHAM, Mass.(BUSINESS WIRE)March 15, 2005NeuroMetrix, Inc.
(Nasdaq: NURO), a medical device company focused on the development and sale of
proprietary products used to diagnose neuropathies, announced today that it has
joined Eli Lilly and Company in an Education & Development Program to
improve awareness and detection of diabetic peripheral neuropathy (DPN).
The primary goal of this strategic relationship is to increase
awareness and understanding of DPN diagnosis among endocrinologists, internal
medicine physicians and other physicians who routinely manage patients with
diabetes.
DPN is a form of nerve damage that is one of the most common chronic
complications of diabetes. It is a
condition caused by microvascular (small blood vessel) damage to nerves and can
lead to foot ulcers and amputations. DPN
is the leading cause of non-traumatic lower-limb amputations among people with
diabetes in the United States. About 60
to 70 percent of people with diabetes have some form of nerve damage and more
than 80,000 amputations are performed each year due to DPN. Sensory symptoms of DPN include numbness,
prickling, aching pain, burning pain, lancinating pain, and allodynia (a
condition in which ordinarily non-painful stimuli evoke pain, such as a bed
sheet touching a leg).
The key to providing optimal care of DPN is early detection so that
preventative measures can be undertaken to avoid progression to advanced damage
which is a cause of ulceration, joint collapse and amputation. It is also important to distinguish between
typical DPN and other common causes of neuropathy. This is not always easy on clinical grounds
alone, said Michael Bryer-Ash, MD, Medical Director of UCLAs Gonda Diabetes
Center. The goal is to increase the number of patients being assessed in their
physicians office. This increased
convenience and prompt diagnosis will make it more likely that appropriate
follow-up and treatment occur.
This strategic relationship combines the strength of two market
leaders. NeuroMetrix is a leading
provider of neuropathy diagnostics using the NeuroMetrix NC-stat®
System as a diagnostic device for DPN, and Lilly is recognized as a worldwide
leader in advancing the care and treatment of patients with diabetes. The NC-stat System allows all physicians to
diagnose neuropathies or diseases of the nerves. The system is comprised of disposable
one-time use NC-stat Biosensors, the NC-stat Monitor which performs the nerve
conduction diagnostic procedure and the NC-stat Docking Station and onCall
Information System, which provide the physician with a highly informative and
detailed report within minutes of completing the study. The NC-stat System is presently used in over
2,200 physician practices and clinics throughout the United States. By working together, both organizations look
to increase the awareness and diagnosis of patients with diabetes and DPN.
Through the agreement, NeuroMetrix and Lilly will conduct a broad
series of 84 educational and development programs across the country over the
next 18 months. The programs will focus
on diabetic
microvascular complications and the diagnosis of DPN. This will include nerve conduction studies,
the NC-stat Systems application in DPN and the benefits of using the NC-stat
System.
Shai N. Gozani, M.D., Ph.D, NeuroMetrixs President and CEO said, We
are excited and honored to partner with Lilly, which is clearly the premier
global company in the diabetes care arena.
Lillys commitment to developing interventions for neuropathies is
clear, as evidenced by the continued development and delivery of pharmaceutical
agents for the treatment of DPN. We
believe that by objectively quantifying neuropathies, the NC-stat system
significantly enhances the physicians ability to diagnose and manage
neuropathies. As such, we look forward
to working with Lilly to educate physicians on the DPN disease state and the
key role of the NC-stat System.
About NeuroMetrix
NeuroMetrix is a medical device company establishing a new standard of
care through the design, development and sale of proprietary products used to
diagnose neuropathies. Neuropathies are
diseases of the peripheral nerves and parts of the spine that frequently are
caused by or associated with diabetes, low back pain and carpal tunnel
syndrome, as well as other clinical disorders.
The NC-stat System, the Companys neuropathy diagnostic system, has been
on the market since May 1999 and is presently used in over 2,200 physicians
offices, clinics and other health care facilities in the United States. The Company holds issued utility patents
covering a number of important aspects of the NC-stat System.
Contact: NeuroMetrix, Inc.
Brad Smith, 781-890-9989
neurometrix.ir@neurometrix.com