EXHIBIT
10.1
Strategic
Supply Agreement
This Strategic Supply
Agreement (this “ Agreement ”) is entered
into as of July 24, 2009 (the “ Effective Date
”) by and between Abbott Molecular Inc., a Delaware
corporation (“ Abbott ”), and NeoGenomics
Laboratories, Inc., a Florida corporation (“
NeoGenomics ”).
Recitals
A. NeoGenomics
operates a genetic testing laboratory that offers a variety of
diagnostic tests for cancer and other diseases, including tests
developed by NeoGenomics and tests developed by others.
B. Abbott
manufactures and sells certain ASR probes that are useful for
analyzing nucleic acids through a process commonly known as
FISH.
C. NeoGenomics
desires to develop and offer a FISH-based test for the diagnosis of
melanoma, and to potentially develop and offer diagnostic tests for
other cancers.
D. NeoGenomics
desires to purchase all of its requirements of Products from
Abbott, and Abbott desires to supply and sell all of
NeoGenomics’ requirements for such Products to NeoGenomics,
which NeoGenomics intends to incorporate into its diagnostic test,
on the terms and conditions set forth in this Agreement.
Now, Therefore , in
consideration of the promises and the mutual covenants contained
herein, the parties agree as follows:
Article
1
Definitions
“
Abbott IVD ” means an In-Vitro Diagnostic test for
melanoma developed by Abbott for aid in diagnosis of malignant
melanoma in skin biopsy specimens (excluding subtyping).
“
Act ” shall mean the United States Food, Drug and
Cosmetic Act and all regulations promulgated thereunder.
“ Affiliate ” shall mean any
entity which directly or indirectly controls, is controlled by, or
is under common control with, another entity. For purposes of this
Agreement, an entity shall be deemed to be in control of another
entity if the former owns, or the partners of the former own,
directly or indirectly, more than fifty percent (50%) of the
outstanding voting equity (or other equity or ownership interest in
the event that such entity is other than a corporation) of the
latter.
“
Agreement ” has the meaning set forth in the
introductory paragraph.
“
Annual Forecast ” has the meaning set forth in Section
3.4(a)(ii).
“
ASR ” means analyte specific reagent.
“ Base
Price ” has the meaning set forth in Section
4.1(a).
“
Calendar Quarter ” means each three (3) month period
during the term of this Agreement which ends, respectively, on
March 31, June 30, September 30 and December 31 of each Calendar
Year, except for the initial Calendar Quarter of the first Calendar
Year, which will begin on the Effective Date and end on September
30, 2009.
“
Calendar Year ” shall mean each twelve (12) month
period during the term of this Agreement which begins on January 1,
and ends on December 31, except for the first Calendar Year which
will begin on the Effective Date and end on December 31,
2009.
“
Change of Control ” means: (a) the sale of all or
substantially all of NeoGenomics’ assets that are used in
designing, developing, validating, marketing, selling, performing
or billing for the Melanoma LDT to a Third Party in a single
transaction or series of related transactions; (b) any merger,
consolidation, sale of stock or other transaction that results in
any “person” or “group” (each as defined in
the Securities Exchange Act of 1934, as amended) either becoming
the “beneficial owner” (as defined in Rule 13d-3 under
the Securities Exchange Act of 1934, as amended), directly or
indirectly, of NeoGenomics’ voting securities(or securities
converted into or exchangeable for such voting securities)
representing fifty percent (50%) or more of the combined
voting power of all of NeoGenomics’ voting securities(on a
fully diluted basis); or (c) any other event that results, by
contract or otherwise, in such person or group obtaining the
ability, directly or indirectly, to elect a majority of the board
of directors of or otherwise direct the management and policies of
NeoGenomics.
“
Change of Control Base Revenue Amount ” has the
meaning specified in Section 14.4.
“ Commencement Date ” has the
meaning set forth in Section 9.5(b).
“ Confidential Information ”
has the meaning set forth in Section 12.1.
“
Conversion Date ” has the meaning set forth in Section
3.4(d).
“ Decision Period ” has the
meaning set forth in Section 9.5.
“ Effective Date ” has the
meaning set forth in the introductory paragraph.
“
Escalated Negotiation Period ” has the meaning set
forth in Section 9.5.
“ Estimated Premium Price ”
has the meaning set forth in Exhibit E hereto.
“
Evaluation Products ” has the meaning set forth in
Section 2.1.
“
Exclusive Products ” means the ASRs, if any, described
in Section 3.2 and identified in Exhibit A as Exclusive
Products.
“
Existing Customer Election ” has the meaning set forth
in Section 3.4(d).
“ FDA ” shall mean the United
States Food and Drug Administration and any successor agency
thereto.
“
FISH ” means a fluorescent in situ hybridization
assay.
“
Initial Annual Forecast ” has the meaning set forth in
Section 3.4(a)(i).
“ Initial Negotiation Period
” has the meaning set forth in Section 9.5.
“ Intellectual Property ”
means any and all: (a) methods, techniques, trade secrets, designs,
know-how, discoveries, inventions, data, information,
documentation, regulatory submissions, formulations, methodologies,
processes, specifications, trademarks, trade dress and other
intellectual property of any kind (whether or not protected under
patent, trademark, copyright or similar law); and (b) trademark
registrations, copyrights, United States and foreign patents and
patent applications covering or claiming any of the
foregoing.
“
IVD Agreement ” has the meaning set forth in Section
9.4(c).
“
IVD Opportunity ” has the meaning set forth in Section
9.4(b).
“ LDT ” means a laboratory
developed test that is independently designed, developed and
validated by a clinical service laboratory.
“ Melanoma LDT ” means a
specific LDT that is anticipated to be independently designed,
developed and validated by NeoGenomics using the Products for use
as an aid in diagnosing malignant melanoma in skin biopsy specimens
(excluding subtyping).
“ Model Forecast ” has the
meaning set forth in Section 3.4(a)(iii).
“ Negotiation Period ” means
the Initial Negotiation Period and the Escalated Negotiation
Period.
“ Non-Conforming Product ”
shall have the meaning set forth in Section 7.6.
“ Pre-Existing Customer ” A
customer of NeoGenomics that purchases the Melanoma LDT prior to
the Conversion Date.
“ Premium Price ” has the
meaning set forth in Section 4.1(b).
“ Products ” shall mean the
analyte specific reagent probes identified by NeoGenomics and set
forth on Exhibit A , including the Exclusive
Products.
“ Purchase Price ” for each
unit of Product shall mean the sum of the Base Price and Premium
Price applicable for such unit at any given time.
“
Quality Systems and GMP Requirements ” shall mean the
current and any future quality system and good manufacturing
practices regulations under 21 C.F.R. Part 820 to the extent that
such regulations are applicable to the Product, as such regulations
are promulgated by the FDA. The applicable Quality Systems and GMP
Requirements for any lot of Product shall be those regulations in
effect when such lot is manufactured for
NeoGenomics.
“
Quarterly Forecast ” has the meaning set forth in
Exhibit E .
“
Quarterly Report ” has the meaning set forth in
Exhibit E .
“
Quarterly Unit Purchases ” shall mean the number of
units of Products ordered by NeoGenomics and shipped by Abbott
pursuant to such order in a given Calendar Quarter, where one (1)
unit of Product constitutes the amount of such Product necessary
for NeoGenomics to perform the Melanoma LDT for one (1) patient.
For purposes of this definition, “ unit ” refers
to one ASR probe at the concentration and volume to be used in the
validated Melanoma LDT, which information will be provided to
Abbott by NeoGenomics in writing promptly following validation of
the Melanoma LDT or any modification of the Melanoma LDT. For
example, if NeoGenomics uses four (4) ASR probes designated as
Products under this Agreement to perform the Melanoma LDT then such
four (4) ASR probes would represent four (4) units of
Products.
“
SEC ” shall mean the United States Securities and
Exchange Commission and any successor agency thereto.
“
Service Revenue ” means the revenue recognized by
NeoGenomics related to performing the Melanoma LDT for Third
Parties, as calculated in accordance with generally accepted
accounting principles and reported by NeoGenomics’ parent
company in its financial statements, as filed with the
SEC.
“
Specifications ” shall mean Abbott’s internal
manufacturing specifications as well as technical specifications
and test protocols relating to the characterization of the Products
identified in Exhibit A , which Specifications will be
included in Exhibit A when the Products are identified
pursuant to Section 2.2 and which may from time to time be amended
by written agreement of the parties including but not limited to
purchased standard control procedure (pscp) changes or an
equivalent document control process.
“
Subsequent Annual Forecast ” has the meaning set forth
in Section 3.4(a).
“
Subsequent Development Agreement ” has the meaning set
forth in Section 9.5(b).
“
Termination Date Revenue Amount ” has the meaning set
forth in Section 14.4(b).
“
Threshold Amount ” has the meaning set forth in
Section 3.4(a)(v).
“
Territory ” shall mean the United States and Puerto
Rico.
“
Third Party ” shall mean a party other than
Abbott or NeoGenomics, or their respective Affiliates.
“
Unaudited Report ” has the meaning set forth in
Section 3.4(a)(iv).
“
Unaudited Revenue ” has the meaning set forth in
Section 3.4(a)(iv).
Article
2
Product
Identification
2.1
Evaluation Products . Abbott will supply NeoGenomics with
Abbott’s ASRs that may be requested from time to time by
NeoGenomics for purposes of NeoGenomics’ evaluation and
determination as to which ASRs to include in its Melanoma LDT, and
for design, development and validation of the Melanoma LDT (“
Evaluation Products ”). Abbott will supply NeoGenomics
with Evaluation Products in quantities that are reasonably
sufficient for evaluating the ASRs and designing, developing and
validating the Melanoma LDT. NeoGenomics shall not use the
Evaluation Products for any other purposes. Unless otherwise
directed by Abbott, NeoGenomics will destroy any unused quantities
of Evaluation Products. NeoGenomics will not bill or seek
reimbursement from any Third Party payor for Evaluation
Products.
2.2
Product Identification . As promptly as reasonably
practicable, but within one hundred twenty (120) days after the
Effective Date, NeoGenomics will determine which ASRs it desires to
purchase under this Agreement for inclusion in its Melanoma LDT.
Once the ASRs are identified and agreed upon in writing by the
parties, Exhibit A will be modified (without necessitating
an amendment to this Agreement) to include such ASRs and their
Specifications, and such ASRs will thereafter constitute the
Products for purposes of this Agreement. Notwithstanding the
foregoing, if, during the term of this Agreement, Abbott develops
new ASRs utilizing in situ hybridization to a chromosomal target
that Abbott reasonably believes may be of interest to NeoGenomics
for use with the Melanoma LDT or a successor thereto, Abbott will
notify NeoGenomics in writing of such new products with a
description of each such product and exclusively offer to
NeoGenomics the right to evaluate such products for a period
of one hundred eighty (180) days from the date of such written
notice for possible inclusion in the Melanoma LDT or a successor
thereto. In the event that NeoGenomics decides during such
evaluation period that any such new product would be appropriate to
include in its Melanoma LDT or any successor thereto, and so
notifies Abbott in writing, then Exhibit A will be further
modified (without necessitating an amendment to this Agreement) to
include such new product and its specifications, and thereafter
such new product will be included in the definition of Exclusive
Products for the purposes of this Agreement. If NeoGenomics elects
not to use the new product in the Melanoma LDT or a successor
thereto, it shall not constitute a Product for purposes of this
Agreement and NeoGenomics shall have no rights with respect
thereto.
2.3
Non-Abbott ASRs . The parties acknowledge and agree that
NeoGenomics will be free to identify which ASRs it desires to
include in the Melanoma LDT, and that it may include ASRs that are
not currently manufactured by Abbott. If NeoGenomics elects to
include in its Melanoma LDT one or more ASRs that are not currently
manufactured by Abbott, it will so notify Abbott, and Abbott may
elect to manufacture the ASR and supply it to NeoGenomics as a
Product under this Agreement. If Abbott chooses not to manufacture
the ASR, Abbott and NeoGenomics will negotiate in good faith to
determine whether: (a) Abbott will obtain the ASR from a Third
Party and supply it to NeoGenomics as a Product under this
Agreement; or (b) NeoGenomics will obtain the ASR directly from a
Third Party that is reasonably acceptable to Abbott and that has a
valid license from Abbott to manufacture the ASR, if applicable. If
none of the ASRs selected by NeoGenomics are manufactured by Abbott
at the time of the initial selection of such ASRs for inclusion in
the Melanoma LDT by NeoGenomics, and Abbott elects not to
manufacture any of such ASRs selected by NeoGenomics so that no
ASRs have been identified as Products pursuant to Section
2.2 within the time periods permitted therein, and the parties
are unable to reach a mutually acceptable alternative arrangement,
then Abbott may terminate this Agreement upon thirty (30) days
prior written notice to NeoGenomics without further obligation or
liability. Abbott represents and warrants that, as of the Effective
Date, it currently manufactures all of the ASRs previously
disclosed to NeoGenomics or listed in any Abbott product catalog
that is current as of the Effective Date.
Article
3
Supply
Terms
3.1
Supply . During the term of this Agreement, and subject to
the terms and conditions contained herein, NeoGenomics shall
purchase all of its requirements of the Products from Abbott, and
Abbott shall supply, or shall cause its Affiliates to supply, to
NeoGenomics such quantities of the Products as may be ordered by
NeoGenomics hereunder. Except for Abbott’s failure to supply
Products as described in Section 5.5, NeoGenomics will not obtain
from any Third Party, or manufacture for itself, any Products (or
other ASRs that are substantially similar to the
Products).
3.2
Exclusivity . If, pursuant to Section 2.2, NeoGenomics
identifies for inclusion in the Melanoma LDT one or more ASRs that
are not currently marketed or sold commercially by Abbott as
individual stand-alone products, each such ASR will be designated
as an “ Exclusive Product ” and will be so
identified on Exhibit A . Abbott will supply the Exclusive
Product(s) to NeoGenomics exclusively in the Territory and, subject
to Section 3.3(b) below, Abbott will not sell the Exclusive
Products to any Third Party in the Territory. Any Products that are
not expressly designated in Exhibit A as Exclusive Products
shall be supplied to NeoGenomics on a non-exclusive basis. Abbott
will use commercially reasonable efforts to ensure that any
Products that are sold by Abbott to customers outside the Territory
will be subject to restrictions prohibiting the further resale or
distribution of such Products in the Territory. For the
avoidance of doubt, once an ASR has been identified as an
“Exclusive Product” on Exhibit A it shall not
cease to be an Exclusive Product due to the marketing or sale of
such ASR by Abbott outside the Territory.
3.3
Exclusivity Exceptions .
(a) Abbott
may sell Exclusive Products to Third Parties outside the Territory;
provided, that Abbott will use commercially reasonable
efforts to ensure that such Exclusive Products are not resold or
distributed in the Territory.
(b) Abbott
may supply Exclusive Products to the academic collaborators
identified in Exhibit B in quantities sufficient for the
collaborators’ research and development purposes. In
addition, Abbott may supply the identified academic collaborators,
in the aggregate, with quantities of Exclusive Products sufficient
to perform no more than one thousand two hundred (1,200) patient
tests per Calendar Year (increasing six percent (6%) per Calendar
Year).
3.4
Maintenance of Exclusivity .
(a)
Annual Forecast and Review .
(i) At
least ninety (90) days prior to the end of the 2010 Calendar Year,
NeoGenomics will provide to Abbott a written reasonable good faith
forecast of the Service Revenue it expects to realize in each of
the following two (2) Calendar Years from sales of the Melanoma LDT
(the “ Initial Annual Forecast ”). If Abbott
does not object to the Initial Annual Forecast within forty-five
(45) days of its receipt of the Initial Annual Forecast, it shall
be deemed accepted by Abbott. If Abbott objects to the Initial
Annual Forecast within such forty-five (45) day period, the parties
will negotiate in good faith to develop an Initial Annual Forecast
that is mutually acceptable to both parties, subject to
subparagraph (iii) below. If the parties are unable to agree
upon a mutually acceptable Initial Annual Forecast within
fifteen (15) days after beginning negotiations, the matter will be
escalated to the President of NeoGenomics (currently Robert
Gasparini) and the President of Abbott (currently Stafford
O’Kelly) for resolution, and if such individuals are unable
to agree upon a mutually acceptable Initial Annual
Forecast within an additional fifteen (15) days, the matter
will be resolved in accordance with Section 15.11.
(ii) At
least ninety (90) days prior to the end of the 2012 Calendar Year
and at least ninety (90) days prior to the end of each third
Calendar Year thereafter during the term of this Agreement (
i.e. , 2015, 2018, etc.), NeoGenomics will provide to Abbott
a written reasonable good faith forecast of the Service Revenue it
expects to realize in each of the following three (3) Calendar
Years from sales of the Melanoma LDT (each, a “ Subsequent
Annual Forecast ” and together with the Initial Annual
Forecast, the “ Annual Forecast ”). If Abbott
does not object to a Subsequent Annual Forecast within forty-five
(45) days of its receipt of such Subsequent Annual Forecast, it
shall be deemed accepted by Abbott. If Abbott objects to a
Subsequent Annual Forecast within such forty-five (45) day period,
the parties will negotiate in good faith to develop a Subsequent
Annual Forecast that is mutually acceptable to both parties,
subject to subparagraph (iii) below; provided however , that
unless otherwise mutually agreed by the parties:
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if
NeoGenomics’ maintains exclusivity pursuant to Section
3.4(b), then the Service Revenue projected in each Calendar Year
forecast included within the applicable Subsequent Annual Forecast
shall not be lower than the actual Service Revenue realized by
NeoGenomics in the last Calendar Year of the immediately preceding
forecast period; or
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if NeoGenomics
does not maintain exclusivity pursuant to Section 3.4(b) and Abbott
does not convert this Agreement to a non-exclusive agreement
pursuant to Section 3.4(c), then the Service Revenue projected in
each Calendar Year forecast included within the applicable
Subsequent Annual Forecast shall not be lower than the actual
Service Revenue realized by NeoGenomics in the last Calendar Year
of the immediately preceding forecast period, divided by
seventy-five one hundredths (0.75).
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If the parties
are unable to agree upon a mutually acceptable Subsequent Annual
Forecast within fifteen (15) days after beginning negotiations, the
matter will be escalated to the President of NeoGenomics (currently
Robert Gasparini) and the President of Abbott (currently Stafford
O’Kelly) for resolution, and if such individuals are unable
to agree upon a mutually acceptable Subsequent Annual
Forecast within an additional fifteen (15) days, the matter
will be resolved in accordance with Section 15.11.
(iii) Notwithstanding
anything in this Agreement to the contrary, unless otherwise
expressly agreed by both parties, neither the Initial Annual
Forecast nor any Subsequent Annual Forecast will be (A) higher than
the model forecast for the corresponding Calendar Year(s) as shown
in the model forecast attached hereto as Exhibit C (the
“ Model Forecast ”) or (B) so long as Abbott
has not exercised its rights pursuant to Section 3.4(c)
hereof to convert NeoGenomics to a non-exclusive arrangement, lower
than thirty-five percent (35%) of the model forecast for the
corresponding Calendar Year as shown in the Model
Forecast.
(iv) NeoGenomics
hereby agrees that it will hire the number of sales people, make
the marketing expenditures and otherwise make the commercial
investments that NeoGenomics reasonably believes are necessary to
achieve each Annual Forecast. NeoGenomics and Abbott agree to meet
periodically to review and discuss NeoGenomics’ sales and
marketing activities with respect to the Melanoma LDT.
(v) On
or before February 15, 2012, and thereafter as soon as figures are
available, but in no event more than forty-five (45) days, after
the end of each Calendar Year during the term of this Agreement,
NeoGenomics will provide Abbott with a written report showing
NeoGenomics’ revenue related to performing the Melanoma LDT
for Third Parties, as calculated in accordance with generally
accepted accounting principles (the “ Unaudited
Revenue ”), during the previous Calendar Year, which the
parties acknowledge shall be based on unaudited financial
information for such Calendar Year (the “ Unaudited
Report ”). Within ninety (90) days after the end of such
Calendar Year during the term of this Agreement, NeoGenomics will
provide Abbott with a written report showing its Service Revenue
during the previous Calendar Year (the “ Audited
Report ”), but only if the Service Revenue in the Audited
Report would differ from NeoGenomics’ Unaudited Revenue as
reported in the Unaudited Report. If the Unaudited Report shows
that NeoGenomics’ Unaudited Revenue during the previous
Calendar Year was less than ninety percent (90%) of the applicable
Threshold Amount (as defined below), then the Unaudited Revenue
will constitute the Service Revenue for such Calendar Year for
purposes of determining whether Abbott may exercise its rights
under Section 3.4(c) or Section 3.4(d), as applicable. If the
Unaudited Report shows that NeoGenomics’ Unaudited Revenue
during the previous Calendar Year is equal to or greater than 90%
of the applicable Threshold Amount, then the parties will wait
until the Audited Report is issued and the actual Service Revenue,
as reported in the Audited Report, will be used for purposes of
determining whether Abbott may exercise its rights under Section
3.4(c) or Section 3.4(d), as applicable. As used in this paragraph:
(A) If Abbott has not exercised its rights pursuant to
Section 3.4(c) or Section 3.4(d), the “ Threshold
Amount ” is the amount of Service Revenue that
NeoGenomics must realize in a given Calendar Year in order to
maintain exclusivity pursuant to Section 3.4(b); or (B) if Abbott
has exercised its rights pursuant to Section 3.4(c), the
“ Threshold Amount ” means the amount of Service
Revenue that NeoGenomics must realize in a given Calendar Year in
order to avoid Abbott having the right to make the Existing
Customer Election pursuant to Section 3.4(d).
(b)
Maintenance of Exclusivity . Beginning with Calendar Year
2011, if NeoGenomics’ Service Revenue in a Calendar Year
equals or exceeds seventy-five percent (75%) of the Service Revenue
forecasted in the Annual Forecast for such Calendar Year, then
NeoGenomics will retain the right to purchase the Exclusive
Products from Abbott on an exclusive basis pursuant to Section
3.2.
(c)
Conversion to Non-Exclusivity . Beginning with Calendar Year
2011, if NeoGenomics’ Service Revenue in a Calendar Year is
less than seventy-five percent (75%) but at least thirty-five
percent (35%) of the Service Revenue forecasted in the Annual
Forecast for such Calendar Year, then Abbott may, in its
discretion, upon written notice to NeoGenomics within ninety (90)
days following NeoGenomics’ submission of a written report
showing the previous year’s Service Revenue to Abbott,
irrevocably discontinue selling the Exclusive Products to
NeoGenomics on an exclusive basis and begin selling them to
NeoGenomics on a non-exclusive basis. In such event, the Exclusive
Products will cease being Exclusive Products for purposes of this
Agreement and Abbott will be free to sell any Products, including
the Exclusive Products, to one or more of its Affiliates or Third
Parties for any purpose; provided, however , that before
exercising its right to convert NeoGenomics to a non-exclusive
arrangement, Abbott will first consult with NeoGenomics regarding
the reasons for the Service Revenue shortfall and will consider in
good faith a reasonable modification to the Annual Forecast to
permit NeoGenomics to maintain exclusivity; provided,
further , that Abbott will have no obligation to agree to such
a modification. Abbott agrees that to the extent it does not
exercise its rights under this Section 3.4(c) within ninety (90)
days of being notified of NeoGenomics’ Service Revenue for
the previous Calendar Year, then Abbott will be deemed to have
waived its right to convert this Agreement to a non-exclusive
agreement as a result of any shortfalls in Service Revenue for such
Calendar Year.
(d)
Existing Customer Election
. If (i) NeoGenomics’ Service
Revenue in a Calendar Year is less than thirty-five percent (35%)
of the Service Revenue forecasted in the Annual Forecast for such
Calendar Year (if Abbott has not converted this Agreement to
a non-exclusive agreement pursuant to Section 3.4(c)); or (ii)
NeoGenomics’ Service Revenue in a Calendar Year is less than
forty-five percent (45%) of the Service Revenue forecasted in the
Annual Forecast for such Calendar Year (if Abbott has
converted this Agreement to a non-exclusive agreement pursuant to
Section 3.4(c)); then, in either such event, Abbott may, in its
discretion, upon written notice to NeoGenomics within nine (9)
months following NeoGenomics submission of a written report showing
the previous Calendar Year’s Service Revenue to Abbott (the
date which is thirty (30 days after NeoGenomics’ receipt of
such notice being the “ Conversion Date ”),
elect to sell the Exclusive Products to NeoGenomics only to the
extent necessary for NeoGenomics to service its Pre-Existing
Customers (the “ Existing Customer Election ”);
provided, however , that before making such election, Abbott
will first consult with NeoGenomics regarding the reasons for the
Service Revenue shortfall and will consider in good faith a
reasonable modification to the Annual Forecast to permit
NeoGenomics to continue to purchase the Exclusive Products on the
non-excusive basis set forth under Section 3.4(c); provided,
further , that Abbott will have no obligation to agree to such
a modification. From and after the Conversion Date, NeoGenomics
will have no right to purchase, and Abbott will have no obligation
to sell, Products in excess of the quantities necessary for
NeoGenomics to provide the Melanoma LDT to its Pre-Existing
Customers (including increases in volume requested by Pre-Existing
Customers). Upon reasonable prior written notice, Abbott’s
independent third party accounting firm, at Abbott’s expense,
will have the right to audit NeoGenomics’ books and records
(but no more than once every twelve (12) months and only at
reasonable times and under reasonable conditions) to verify that
Products sold to NeoGenomics are being used solely to service
Pre-Existing Customers. Prior to any such audit, Abbott’s
independent third party accounting firm shall be required to
execute a separate confidentiality agreement with
NeoGenomics, in form and substance reasonably acceptable to
NeoGenomics, that, among other things, shall prohibit such accounting firm from disclosing
the identities of any of NeoGenomics’ customers to Abbott,
any Affiliate of Abbott or any Third Party. If NeoGenomics
intentionally and materially exceeds its rights under this Section
3.4(d), Abbott shall have the right to terminate this Agreement
pursuant to Section 14.2. Abbott agrees that if it does not make
the Existing Customer Election within nine (9) months of being
notified of NeoGenomics’ Service Revenue for the previous
Calendar Year, then Abbott will be deemed to have waived its right
to make the Existing Customer Election for such Calendar
Year.
(i) If
Abbott converts this Agreement to a non-exclusive agreement
pursuant to Section 3.4(c), Abbott will continue to sell the
Products to NeoGenomics on the terms and conditions set forth in
this Agreement, except for terms related to exclusivity;
provided, however , that if, following such conversion,
Abbott sells Products to any Third Party (other than academic
collaborators) for a price that is lower than the Purchase Price
payable by NeoGenomics hereunder, then NeoGenomics will be entitled
to such lower price for all quantities of such Products delivered
to it for as long as such lower price is effective for any other
buyer; provided, further, that, if the lower price payable
by a Third Party is based on tiered pricing or other volume
discount, NeoGenomics will be required to commit to at least the
same purchase volume as the Third Party in order to be entitled to
the lower price.
(ii) If
Abbot makes the Existing Customer Election pursuant to Section
3.4(d), Abbott will continue to sell the Products to NeoGenomics on
the terms and conditions set forth in this Agreement, except for
terms related to exclusivity and subject to the limitations set
forth in Section 3.4(d); provided, however , that if,
following such election, Abbott sells Products to any Third Party
(other than academic collaborators) for a price that is lower than
the Purchase Price payable by NeoGenomics hereunder, then
NeoGenomics will be entitled to purchase the Products for a price
that is one hundred ten percent (110%) of such lower price for all
quantities of such Products delivered to it for so long as such
lower price is effective for any other buyer; provided,
further, that, if the lower price payable by a Third Party is
based on tiered pricing or other volume discount, NeoGenomics will
be required to commit to at least the same purchase volume as the
Third Party in order to be entitled to the lower price.
(f)
Changes to Annual Forecast . If (i) Abbott converts this
Agreement to a non-exclusive agreement pursuant to Section 3.4(c);
(ii) the average national reimbursement rate for automated FISH
testing using CPT Code 88367 declines by greater than five percent
(5.0%) from one Calendar Year to the next; (iii) a Third Party
begins marketing an LDT incorporating any of the Products that is
reasonably anticipated to compete in a material way with the
Melanoma LDT; or (iv) Abbott is successful in developing and
obtaining FDA approval or clearance for the Abbott IVD; then Abbott
and NeoGenomics will negotiate in good faith to revise the Annual
Forecast currently in effect pursuant to Section 3.4(a) and/or the
performance thresholds set forth in Sections 3.4(b), 3.4(c) and
3.4(d) to reflect the anticipated impact of such event on
NeoGenomics’ Service Revenue. If Abbott makes the Existing
Customer Election, then NeoGenomics will no longer be required to
provide Annual Forecasts pursuant to this Section 3.4, but will
still comply with the forecasting and ordering procedures set forth
in Article 5.
(g)
Examples . Examples illustrating the potential application
of the provisions set forth in this Section 3.4 under various
scenarios are attached hereto as Exhibit D . Such examples
are provided for illustrative purposes only and are not binding on
either party.
3.5
Sole Remedies . The rights to convert this Agreement to a
non-exclusive agreement, or to make the Existing Customer Election,
pursuant to Sections 3.4(c) and 3.4(d) above shall constitute
Abbott’s sole and exclusive remedies with respect to
NeoGenomics’ failure to meet the Service Revenue levels
forecasted in the Annual Forecast, except to the extent such
failure is due to NeoGenomics’ fraud or willful
misconduct.
3.6
Compliance. Products manufactured by Abbott for NeoGenomics
under this Agreement shall be manufactured and tested by Abbott in
accordance with the Specifications, Quality System and GMP
Requirements, and all applicable national, state and local laws,
regulations and guidelines.
3.7
Specifications. The Specifications for the Products will be
included in Exhibit A when the Products are identified
pursuant to Section 2.2. The parties may from time to time amend
said Specifications for any Product by mutual written
agreement; provided , that if Abbott is required by
applicable law, rule or regulation to modify the Products or the
Specifications, it will be free to do so, but will provide
NeoGenomics with as much advance notice of such modification as
practicable under the circumstances. In the event that an amendment
to the Specifications for a Product affects the price for such
Product, the parties shall, prior to amending the Specifications,
agree in writing upon any price adjustments and ordering and
delivery schedules for such Product.
3.8
Use of Products . NeoGenomics will not: (a) resell or
distribute any Evaluation Products or Products obtained from Abbott
under this Agreement to any Third Party; (b) use any Evaluation
Products or Products past their stated expiration date; (c) use any
Evaluation Products in any manner inconsistent with their intended
use; or (d) use any Evaluation Products or Products outside the
Territory.
3.9
Books and Records; Audit Rights . NeoGenomics will keep
books and records that accurately show the Service
Revenue. Such books and records shall be preserved
for three (3) years from the last day of each Calendar Year in
which such Service Revenue was realized and shall be open to audit
by an independent accounting firm reasonably acceptable to
NeoGenomics and Abbott, no more frequently than once in any twelve
(12) month period, at reasonable times and under reasonable
conditions and upon at least thirty (30) days prior written notice
to NeoGenomics. All information contained in NeoGenomics’
books and records shall constitute Confidential Information for
purposes of Article 12 of this Agreement and the independent
accounting firm will be required to execute a separate
confidentiality agreement reasonably acceptable to NeoGenomics
that, among other things, shall prohibit such accounting firm from
disclosing the identities of any of NeoGenomics’ customers to
Abbott, any Affiliate of Abbott or any Third Party. Abbott will use
the reports of the independent accounting firm only for the purpose
of verifying NeoGenomics’ Service Revenue for the applicable
period. Once audited, the books and record shall be closed for the
applicable Calendar Year(s) and may not be audited again pursuant
to this Section 3.9. The costs of such an audit shall be borne by
Abbott; provided, however , that, if such audit
determines that the Service Revenue reported by NeoGenomics for the
audited Calendar Year(s) is at least ten percent (10%) more than
the Service Revenue determined by the auditor for such Calendar
Year(s), then NeoGenomics will promptly reimburse Abbott for the
costs of such audit. Abbott’s right to audit a specific
Calendar Year will terminate three (3) years after the last day of
such Calendar Year.
Article
4
Purchase
Price And Terms
4.1
Purchase Price. The purchase price (“ Purchase
Price ”) for the Products shall consist of a base
component and a premium component.
(a)
Base Purchase Price . The base component of the Purchase
Price (the “ Base Price ”) shall be as set forth
on Exhibit E hereto.
(b)
Premium Purchase Price . The premium component of the
Purchase Price (the “ Premium Price ”) shall be
as set forth on Exhibit E hereto.
(c)
Books and Records; Audit Rights . NeoGenomics will keep
books and records that accurately show the Quarterly
Unit Purchases. Such books and records shall be
preserved for three (3) years from the last day of each Calendar
Quarter in which such Quarterly Unit Purchases were made and shall
be open to audit by an independent accounting firm reasonably
acceptable to NeoGenomics and Abbott, no more frequently than once
in any twelve (12) month period, at reasonable times and under
reasonable conditions and upon at least thirty (30) days prior
written notice to NeoGenomics. All information contained in
NeoGenomics’ books and records shall constitute Confidential
Information for purposes of Article 12 of this Agreement and the
independent accounting firm will be required to execute a separate
confidentiality agreement reasonably acceptable to
NeoGenomics that, among other things, shall prohibit such
accounting firm from disclosing the identities of any of
NeoGenomics’ customers to Abbott, any Affiliate of Abbott or
any Third Party. Abbott will use the reports of the independent
accounting firm only for the purpose of determining the accuracy of
the Quarterly Reports and ensuring proper payment of the Premium
Price. Once audited, the Quarterly Reports and the Premium Price
payments shall be closed for the applicable Calendar Quarter(s) and
may not be audited again. Except as provided below, within sixty
(60) days after notice from Abbott following completion of the
independent accounting firm’s audit covering a given Calendar
Quarter, NeoGenomics will pay to Abbott the amount of any Premium
Price determined by such audit to be outstanding. The costs of such
an audit shall be borne by Abbott; provided, however , that,
if such audit determines that the aggregate Premium Price paid by
NeoGenomics for the audited Calendar Quarter(s) to be at least ten
percent (10%) less than the Premium Price determined by the auditor
to be due and payable, then NeoGenomics will
promptly reimburse Abbott for the costs of such audit. If
such audit determines that NeoGenomics overpaid the amount of
Premium Price otherwise determined by the auditor to be due and
payable for the audited Calendar Quarter(s), then Abbott will
credit the amount of such overpayment to NeoGenomics against future
amounts payable by NeoGenomics under this Agreement. Abbott’s
right to audit a specific Calendar Quarter or the Premium Price
payments owed with respect thereto, will terminate three (3) years
after Abbott’s receipt of the Quarterly Report relating to
such Calendar Quarter.
4.2
Evaluation Products . Abbott shall provide NeoGenomics with
reasonable quantities of Evaluation Products at no cost to
NeoGenomics.
Article 5
Orders And
Forecasting
5.1
Forecasting and Ordering . Within thirty (30) days following
identification of the Products in Exhibit A , NeoGenomics
shall provide Abbott with a written good faith forecast for
quantities of Products required by NeoGenomics for the subsequent
twelve (12) month period. The forecast shall be a rolling annual
forecast and it shall be updated by NeoGenomics at least ten (10)
days before the end of each Calendar Quarter and shall provide
NeoGenomics’ forecasted requirements of Products for the
subsequent twelve (12) month period. The first three (3) months of
each such forecast shall constitute a firm purchase order for
Products. The last nine (9) months of each forecast shall not be
binding on either party and shall be used for planning purposes and
safety stock building. In any Calendar Year, NeoGenomics will not
issue a forecast for, or order, a greater quantity of Products than
NeoGenomics reasonably believes will be necessary to fulfill its
anticipated needs for the Melanoma LDT during such Calendar Year.
If Abbott reasonably believes that NeoGenomics has ordered Products
in excess of the foregoing limitation, Abbott reserves the right to
adjust the applicable purchase order to withhold shipment of such
excess quantities.
5.2
Purchase Orders . Firm purchase orders shall be placed at
the end of each Calendar Quarter detailing the exact quantities of
Product which NeoGenomics requires to be delivered in the following
Calendar Quarter, consistent with the forecast provided pursuant to
Section 5.1. Orders shall be placed upon NeoGenomics’
purchase order forms, specifying quantities of Products ordered and
the initial requested delivery dates, which will be no less than
three (3) days after Abbott’s receipt of