DISEASE MANAGEMENT
SERVICES AGREEMENT
ENHANCED CARE INITIATIVES, INC.
This DISEASE MANAGEMENT SERVICES AGREEMENT (this "DMSA"), is made
and entered into as of October 16, 2006, by and between ALERE MEDICAL
INCORPORATED., a California corporation ("ALERE") and ENHANCED CARE
INITIATIVES, INC., a Connecticut corporation, ("Subcontractor") (sometimes
hereinafter, ALERE and Subcontractor may each be referred to individually
as a "Party" and collectively as the "Parties"), with reference to the
following facts:
RECITALS
A. ALERE offers disease management tools, services and systems to Payors
which are designed to assist with and improve management of health care
outcomes for patients
B. ALERE provides said disease management tools, services and systems both
directly and through contracts with DM Vendors.
C. ALERE has contracted to provide disease management services to TUFTS
HEALTH PLAN, ("Tufts").
X. Xxxxx offers various Commercial and Medicare Health Plans to Members.
X. Xxxxx has engaged ALERE to provide, directly or indirectly through
subcontracts with DM Vendors, disease management services to Tuft's
Members, and ALERE desires to provide or arrange for Subcontractor to
provide ALERE with some of those disease management services on behalf of
Tufts, all in accordance with the terms and subject to the conditions of
this Agreement.
F. Capitalized terms used in this DMSA and through this Agreement shall
have the respective meanings set forth in the Schedule of Definitions
attached to this DMSA as EXHIBIT A or as otherwise defined herein.
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing recitals (which are
incorporated in full herein by this reference), the representations,
warranties, covenants and conditions exchanged by the Parties herein below,
and for other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, Subcontractor and ALERE hereby agree as
follows:
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1 SCOPE AND INTERPRETATION OF AGREEMENT.
1.1 SCOPE OF DISEASE MANAGEMENT AND MANAGEMENT SERVICES/TUFTS.
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1.1.1 DISEASE MANAGEMENT SERVICES. Subject to the terms and conditions of this
DMSA, Subcontractor, as a subcontractor of ALERE, shall provide disease
management services to Tufts and/or its Members in accordance with the
services, functions, tasks and responsibilities described in various
statements of work to be executed by Subcontractor and ALERE (each a
"Statement or Work" or "SOW") (the "Disease Management Services").
Subcontractor shall perform all Disease Management Services in accordance
with all applicable terms and conditions of this Agreement and all
then-applicable Laws and Regulations.
1.1.2 APPLICABILITY TO TUFTS AFFILIATES. At ALERE's request, Subcontractor will
provide Disease Management Services pursuant to the terms and conditions
of a SOW to any current or future Tufts Affiliate that desires to
participate in one or more programs being administered by ALERE. To the
extent that it may be required by the law of the state in which a Tufts
Affiliate is licensed, ALERE, Subcontractor and such Tufts Affiliate will
enter into a separate agreement in form and content similar to this
Agreement. However, the Parties understand that no current or future
Tufts Affiliate is required to utilize Subcontractor's Disease Management
Services or participate in programs administered by ALERE which utilize
Subcontractor's services at any time during the Term. Furthermore, ALERE
shall be free to provide the Disease Management Services to Tufts
directly, through Affiliates or through contracts with Third Party
vendors, including those vendors which may compete with Subcontractor.
1.1.3 GUARANTEES. Alere make no guarantees or representations to Subcontractor
concerning any minimum or maximum number of Tuft's Members which may be
the subject of Subcontractor's Disease Management Services, or of any
minimum or maximum amount of Service Fees or other compensation that will
be generated from Subcontractor's performance or administration of the
Disease Management Services, unless explicitly provided to the otherwise
in the applicable SOW.
1.2 STATEMENTS OF WORK. This DMSA establishes the standard terms and
conditions pursuant to which the Disease Management Services and all
other Services and Deliverables shall be furnished by Subcontractor to
ALERE. Subject to the terms and conditions of this DMSA, the Parties will
prepare one or more SOWs to identify and describe such Services and
Deliverables and the Parties' responsibilities with respect thereto,
which SOW must be dated and executed by Subcontractor and ALERE in order
to become effective. Each SOW shall set forth in detail: (i) a reference
to this DMSA, which reference will be deemed to incorporate all of the
provisions of this DMSA
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into the SOW; (ii) an effective date for the SOW and/or for the
commencement of Services to be furnished under such SOW; (iii) an
identification of the involved Tufts Affiliate and the specific programs
comprising the Disease Management Services to be furnished by
Subcontractor to ALERE; (iv) a description of the services, functions,
tasks and responsibilities of Subcontractor in furnishing such Disease
Management Services and of the Tufts Affiliates for whom such Disease
Management Services are being furnished; (v) a description of any other
specific Services or Deliverables to be furnished by Subcontractor; (vi)
Performance Targets and/or Service Level Standards to which the Services
may be subject and/or the manner in which such targets or standards will
be determined or developed on an annual basis; (vii) the Service Fees
payable to Subcontractor for any Disease Management Services or other
Services; and (viii) such other matters as the Parties shall mutually
agree upon. A SOW will be developed for each Disease Management Service
now or hereinafter furnished by Subcontractor hereunder. This DMSA shall
remain in effect for the term specified in, and subject to the Parties'
respective rights under, Section 13 hereof. Each SOW may be separately
terminated pursuant to its terms or as otherwise set forth herein without
affecting any other SOW. However, the termination of this DMSA shall
terminate all then outstanding SOWs.
1.3 PROPERTY USED TO PERFORM SERVICES. Unless any SOW expressly provides to
the contrary, (i) all tangible and intangible property required by
Subcontractor to perform any Services hereunder ("Necessary Property")
shall be the sole financial responsibility of Subcontractor, and (ii) all
such Necessary Property shall remain the sole and exclusive property of
Subcontractor. In the event a SOW provides that Alere or Tufts is
financially responsible (as defined below) for any several Necessary
Property , all such several Necessary Property shall remain the sole and
exclusive property of that entity. As used herein, "financial
responsibility" shall mean the ultimate responsibility for incurring the
costs and expenses required in order to purchase, lease, license, develop
or otherwise acquire Necessary Property that is separate and distinct
from the fees payable to Subcontractor under any SOW.
1.4 INTERPRETATION OF SOWS; ORDER OF PRECEDENCE. In the event of conflict or
inconsistency between the provisions of any SOW and the provisions of
this DMSA with respect to the provision of any particular Disease
Management service or other service, the provisions of the SOW will
govern and control with respect to the interpretation of the provision as
used in that SOW; provided, however, that the provisions of such SOW
shall be construed so as to give effect to all applicable provisions of
this DMSA to the fullest extent possible. In the event of conflict or
inconsistency between two or more SOWs that must be interpreted together,
the SOW most recently dated shall govern with respect the conflicting
provision.
2 PROVISION OF SERVICES BY SUBCONTRACTOR.
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2.1 GENERAL REQUIREMENTS. Subcontractor shall perform all Services in
accordance with (i) the general terms and conditions of this DMSA, and
(ii) the specific terms, conditions, scope, specifications, schedules,
and all other requirements set forth in each SOW applicable to such
Services (collectively, "SOW Requirements"). Any material changes to any
SOW Requirements shall be made pursuant to the Change Order Process set
forth in Section 10 below.
2.2 READINESS; IMPLEMENTATION SERVICES.
2.2.1 OPERATIONAL AND SYSTEM READINESS. Subcontractor represents, warrants and
covenants to ALERE that, prior to any SOW Effective Date, Subcontractor
shall have achieved Operational and System Readiness to provide all
Services contemplated by such SOW in accordance with the terms and
conditions of this Agreement.
2.2.2 IMPLEMENTATION SERVICES; IT DEVELOPMENT WORK FOR TUFTS. Subcontractor
agrees to perform and complete any IT Development Work, personnel
training, implementation of operating procedures and protocols and other
work as may be necessary or appropriate to achieve Operational and System
Readiness with respect to Disease Management Services or other Services
required to be furnished to Tufts under a SOW ("Implementation Services")
prior to the applicable SOW Effective Date. All Implementation Services
shall be performed at the sole cost and expense of Subcontractor unless
otherwise expressly provided in a SOW.
2.3 COMPLIANCE WITH LAWS AND REGULATIONS. As an integral part of any Services
provided pursuant to this Agreement, Subcontractor shall obtain all
licenses and permits necessary under applicable Laws and Regulations to
perform such Services and shall comply with all Laws and Regulations
applicable to performance of such Services and the operation of
Subcontractor's business. Subcontractor shall be financially responsible
for all costs and fees and taxes associated with securing and maintaining
such licenses and permits and complying with its obligations under this
Section. In addition, and without any additional cost, Subcontractor
shall assist and cooperate with ALERE as reasonably necessary for Tufts
to maintain compliance with any Laws and Regulations and any CMS
policies, guidelines and manuals pertaining to the marketing, offering or
operation of their Health Plans, including, but not limited to,
compliance with any such Laws and Regulations, policies, guidelines and
manuals applicable to Subcontractor as a contractor of Tufts and any
notice or filing requirements with CMS or any other Governmental
Authority. Without limiting the generality of the foregoing,
Subcontractor agrees to the following:
2.3.1 INCORPORATION OF LEGAL AND REGULATORY REQUIREMENTS. The performance of
the Services may be subject to the requirements of Laws and Regulations
applicable to the ALERE, the Tufts Affiliates or their Health
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Plans, the Services or Subcontractor's operations that have not been
specifically identified in this Agreement. In such case, any provisions
now or hereafter required to be included in this Agreement by applicable
Laws and Regulations or by Governmental Authorities exercising
jurisdiction over ALERE, Tufts, their Health Plans, the Services or
Subcontractor's operations, including, without limitation, Medicare Laws
and Regulations, administrative guidelines issued by CMS and requirements
relating to Federal Employees Health Benefit Programs, shall be binding
upon and enforceable against Subcontractor, ALERE or Tufts, whether or
not expressly provided in this DMSA.
2.3.2 REGULATED ACTIVITIES; DELEGATION. The Parties acknowledge and agree that
the Services shall not include the selection or credentialing of medical
professionals or providers. To the extent that any Services include other
activities that are regulated by Laws and Regulations or governed by
standards adopted by Accreditation Organizations ("Regulated
Activities"), Subcontractor shall cooperate with Tufts to facilitate its
compliance with such Laws and Regulations and such standards.
Subcontractor shall not subcontract or delegate any Services or any other
Regulated Activities (including as a result of a Change of Control) to a
Third Party without the prior written consent of ALERE. Any such
subcontract or delegation, if consented to (an "Approved Delegation"),
shall be performed by the delegate in accordance with the terms and
conditions of this Agreement and, if pertaining to the Medicare Health
Plans, Tuft's contractual obligations to CMS. Subcontractor agrees that
any agreements of Subcontractor with respect to an Approved Delegation
shall be in writing, signed by the parties to be bound thereby and in
compliance with all applicable Medicare and other Laws and Regulations.
In the event that a delegate of Subcontractor fails or is unable (for any
reason whatsoever) to perform in a satisfactory manner any services,
activities or other obligations which have been sub-delegated pursuant to
an Approved Delegation, then ALERE shall have the right to suspend,
revoke or terminate such Approved Delegation effective upon the date set
forth in a written notice furnished to Subcontractor. Any purported
delegation or subcontract in violation of this Section shall be not
binding upon or recognized.
2.3.3 MAINTENANCE OF BOOKS AND RECORDS. Subcontractor shall keep and maintain,
in accordance with prudent business practices and applicable Laws and
Regulations, accurate, complete and timely books, documents, records and
accounts of all transactions occurring as part of the Services, and
Compensation Records (collectively, "Records"). Subcontractor shall
retain all Records during the Term and for an additional period of six
(6) years (or such longer period as may be required under applicable law)
from this Agreement's termination and the expiration of any Transition
Assistance Period and for such longer period as may be required by (i)
any SOW, (ii) any on-going audit or investigation of Tufts, ALERE,
Subcontractor or any other Person being conducted by any Governmental
Authority related to this
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Agreement or (iii) applicable Laws and Regulations. Subcontractor shall,
promptly upon request by ALERE, provide ALERE with electronic copies of
any and all Records relating to the performance of any Services for them
hereunder at Subcontractor's expense. In addition, Subcontractor shall
permit originals or copies of such Records to be inspected by
Governmental Authorities at the Service Locations or elsewhere, both
before and after any termination or expiration of this DMSA. The
provisions of this Section shall survive the expiration or earlier
termination of any SOW or this DMSA for any reason whatsoever.
2.3.4 INSPECTION AND AUDIT OF RECORDS AND FACILITIES. Upon request, demand or
court order, Subcontractor shall provide timely access to ALERE, Tufts,
any Accreditation Organization or any Governmental Authority (including,
without limitation, the U.S. Department of Health and Human Services,
CMS, the Comptroller General or their designees) (each a "Requesting
Entity") for the purpose of auditing and/or inspecting the facilities,
offices, equipment and Records of Subcontractor relating to the
performance of the Services. In connection with such audits or
inspections, Subcontractor shall cooperate and comply with any lawful
requirements or directives of the Requesting Entity within the time
periods specified by such Requesting Entity. If, as a result of any audit
or inspection, or otherwise, an Accreditation Organization or
Governmental Authority requires changes to the facilities, books,
Records, processes, operations or Services of Subcontractor,
Subcontractor shall, subject to Subcontractor's right to terminate set
forth in Section 10, make such changes in a timely manner, and at
Subcontractor's sole expense. Subject to Subcontractor's right to
terminate set forth in Section 10, all changes required for Subcontractor
to be in compliance with any standards required by any Accreditation
Organization or Governmental Authority shall be made timely by
Subcontractor and at Subcontractor's sole expense, unless otherwise
agreed in writing by the Parties.
2.3.5 MEDICARE PARTICIPATION STANDARDS. Subcontractor acknowledges that some of
the Service Fees, compensation or expenses payable pursuant to this DMSA
will consist of Federal funds. In view of the foregoing, Subcontractor
agrees to comply with the following: Title VI of the Civil Rights Act of
1964, as amended (42 USC ss. 2000d et seq.); Sections 503 and 504 of the
Rehabilitation Act of 1973, as amended (29 USC xx.xx. 793 and 794); Title
IX of the Education Amendments of 1972, as amended (20 USC ss. 1681 et
seq.); Section 654 of the Omnibus Budget Reconciliation Act of 1981, as
amended (41 USC ss. 9849); the Americans with Disabilities Act (42 USC
ss. 12101 et seq); the Age Discrimination Act of 1975, as amended (42 USC
ss. 6101 et seq.); and the Vietnam Era Veterans Readjustment Assistant
Act (38 USC ss. 4212); together with all applicable implementing
regulations, rules guidelines and standards as from time to time are
promulgated thereunder by applicable Governmental Authorities.
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2.3.6 COMPLIANCE WITH MEDICARE LAW AND CMS GUIDELINES. Subcontractor shall
comply with all Medicare Laws and Regulations and administrative
guidelines issued by CMS to the extent applicable to the performance of
the Services. Subcontractor shall perform the Services in a manner that
is consistent with, and permits Tufts to comply with their contractual
obligations to CMS. Without limiting any other provision of this
Agreement, Subcontractor shall comply with all Medicare Laws and
Regulations and CMS guidelines, instructions and policies with respect to
the security and confidentiality of medical records and personal
information of Tuft's Members and Member record accuracy requirements, as
set forth in applicable Medicare Laws and Regulations. The obligations
imposed upon Subcontractor by the preceding sentence survive the
termination of the Agreement.
2.3.7 NONDISCRIMINATION. Subcontractor agrees that the Services shall be
rendered without regard to health status, race, religion, color, creed,
national origin, ancestry, religion, physical handicap, medical condition
(including HIV status), mental status, age (except as provided by law),
martial status, sex, sexual orientation or gender identity. In addition,
Subcontractor agrees that it shall not unlawfully discriminate against
any employee or applicant for employment because of race, religion,
color, creed, national origin, ancestry, religion, physical handicap,
medical condition (including HIV status), mental status, age, martial
status, sex, sexual orientation or gender identity. Subcontractor agrees
that the evaluation and treatment of its employees and applicants for
employment are, and will be, free from such unlawful discrimination.
Subcontractor agrees that it shall comply with the provisions of all Laws
and Regulations relating to equal and fair employment.
2.3.8 EQUAL OPPORTUNITY EMPLOYER/AFFIRMATIVE ACTION. The provisions of
Executive Order 11246, as amended (Equal Opportunity/Affirmative Action),
38 USC ss.4212, as amended, (Vietnam Era Veterans Readjustment Act), and
Section 503 of the Rehabilitation Act of 1973, as amended (Handicapped
Regulations), together with the implementing regulations (found at 41 CFR
xx.xx. 60-1, & 60-2, 41 CFR ss. 60-250, and 41 CFR ss. 60-741,
respectively), rules guidelines and standards as from time to time are
promulgated thereunder by applicable Governmental Authorities, are
incorporated by reference into this DMSA, and Subcontractor agrees to
abide by the foregoing provisions that, as a contractor of Tufts, are
applicable to Subcontractor.
2.3.9 FEDERAL EMPLOYEES HEALTH BENEFIT PROGRAM. To the extent Services are
provided to Members who are enrolled in the Federal Employees Health
Benefit Program, Subcontractor shall comply with all of the provisions of
the Federal Employees Health Benefit Program Standard Contract for
Community-Rated Health Maintenance Organization Carriers (the "FEHBP
Contract") set forth in EXHIBIT B to this Agreement, which provisions are
hereby incorporated into this Agreement. Subcontractor shall
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comply with each of the provisions set forth in EXHIBIT B to the same
extent that such provisions apply to Tufts as "Contractor" or "Prime
Contractor" in the applicable FEHBP Contract. ALERE may amend EXHIBIT B
by providing written notice of such amendment to Subcontractor at the
address set forth in the Notice provision of this Agreement to the extent
that amendments to the FEHBP Contract or a new or replacement contract
between Tufts and the U.S. Office of Personnel Management require that
other provisions be incorporated into their subcontracts.
2.3.10 MONITORING AND ASSESSMENTS. ALERE shall have the right to evaluate, audit
and monitor Subcontractor's performance of all Services on a periodic and
on-going basis throughout the Term. In connection therewith,
Subcontractor shall: (i) furnish ALERE's designated representatives with
such access to the Subcontractor's facilities, operations, Records,
activities and personnel as may be reasonably necessary or appropriate
for ALERE to monitor, assess and evaluate all activities associated with
the Services or this Agreement and/or as otherwise required or
recommended by, and in accordance with, applicable Laws and Regulations,
the standards of Accreditation Organizations; (ii) to the extent such
conversations are recorded, provide ALERE, promptly upon request, with an
accurate and complete CD ROM containing a recording of all calls with
Members that are handled by any or all Subcontractor representatives in
accordance with ALERE's specifications (which may include specifications
as to the call dates, the specific Members called, the Subcontractor
representative making the call, or other requirements); and (iii)
reasonably cooperate with ALERE as necessary for ALERE or Tufts to
monitor, evaluate and audit the activities of Subcontractor in connection
with the performance of the Services, including furnishing ALERE or Tufts
with reasonable and appropriate access to Subcontractor's operations and
activities. The rights granted to ALERE in this Section shall not relieve
Subcontractor from any obligations imposed upon Subcontractor under this
Agreement or any SOW.
2.3.11 BUSINESS INTEGRITY. Subcontractor agrees to be bound by the provisions
set forth at 45 C.F.R. Part 76 during the Term and so long as any SOW is
outstanding relating to any Medicare Health Plan. Subcontractor
represents, warrants and covenants to ALERE that neither Subcontractor
nor any personnel or Authorized Contractor of Subcontractor is presently
excluded by the Department of Health and Human Services Office of the
Inspector General or by the General Services Administration from
participation in federal health care programs or has any officer,
director or principal who is convicted of a felony. In the event that any
personnel or Authorized Contractors of Subcontractor become excluded from
participation in federal health care programs or convicted of a felony
during the Agreement, then Subcontractor shall immediately notify ALERE
thereof and discontinue using such personnel or Authorized Contractors in
the performance of any Services. In the event that Subcontractor has
breached its representations in this Section, becomes excluded from
participation in federal
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health care programs or has officers, directors or principals convicted
of a felony, or Subcontractor fails to take immediate actions as required
by the preceding sentence, then ALERE shall be permitted to terminate
this Agreement, in its entirety or as to any relevant part, immediately
upon the furnishing of written notice to Subcontractor and/or take such
other corrective or remedial action as warranted under the circumstances.
2.3.12 ADDITIONAL STATE REGULATORY REQUIREMENTS. In addition to the foregoing,
the Parties shall comply with any state regulatory requirements set forth
in any applicable SOW ("Additional State Requirements").
2.3.13 SUSPENSION AND TERMINATION. Subcontractor, on behalf of itself and its
Affiliates and Contractors, understands and agrees that if Subcontractor
fails to perform its obligations under this Section 2.3, then ALERE shall
have the right to suspend or terminate this Agreement or applicable SOW,
in its entirety or as to any applicable service or function included
within the Services. Any termination of this Agreement or a SOW shall be
effective immediately upon the sending of written notice to Subcontractor
unless such default or noncompliance with the obligations of this Section
2.3 are curable and, in such event, this Agreement, the SOW or
Contractor, as the case may be, shall only be terminated if Subcontractor
fails to cure such default of noncompliance within thirty (30) days after
receipt of written notice or within such lesser period of time as
directed by a Governmental Authority.
2.4 FINES AND PENALTIES. As between Subcontractor and ALERE/Tufts and,
Subcontractor shall be solely responsible for any fines or penalties
arising out of or related to any noncompliance by Subcontractor with any
Laws and Regulations applicable to Subcontractor, the performance of the
Services or noncompliance with the obligations under Section 2.3 by
Subcontractor.
2.5 ACCURACY OF DATA. Subcontractor shall be responsible for ensuring that
all data and information submitted by Subcontractor to ALERE or Tufts, or
generated or created by Subcontractor during the performance of its
obligations under this Agreement is accurate, complete, provided in a
timely manner and free from any errors when used or transmitted in
connection with performance of the Services; provided, however that
Subcontractor shall not be responsible for the use or re-transmission of
data that was inaccurate when originally transmitted to Subcontractor by
ALERE or Tufts. Subcontractor shall be responsible for correcting any
errors or inaccuracies in any such data or information within the
possession or control of Subcontractor promptly (but in no event more
than two (2) business days) after learning of such errors or
inaccuracies. Subcontractor's failure to comply with this Section shall
constitute a material breach of this DMSA.
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2.6 REPORTING REQUIREMENTS. Subcontractor shall be responsible for providing
ALERE, Tufts, any Governmental Authorities or other Third Parties with
all such standard and customized reports as may be required by each SOW,
in accordance with the time requirements specified in such SOW. All such
reports shall be accurate and complete when furnished and provided at
Subcontractor's sole cost and expense unless otherwise expressly provided
in the applicable SOW.
2.7 SUBCONTRACTOR ACCOUNT EXECUTIVE. During the Term and for so long as any
SOW remains outstanding, Subcontractor shall designate and make available
to ALERE an individual approved by ALERE (the "Subcontractor Account
Executive") who will serve as primary liaison between Subcontractor and
ALERE. The Subcontractor Account Executive shall (i) be the primary
Subcontractor contact for ALERE with respect to all matters related to
this Agreement, except as otherwise provided in any SOW, (ii) have
overall responsibility for managing and coordinating the performance of
the Services, and (iii) meet regularly (and as frequently as is needed)
with the ALERE Representative. The Subcontractor Account Executive may
designate in writing another individual to be the point of contact for
ALERE with respect to the Services to be performed under a particular SOW
so long as such individual is acceptable to ALERE.
2.8 ALERE REPRESENTATIVE. During the Term and for so long as any SOW remains
outstanding, ALERE will designate an individual who will serve as primary
liaison between Subcontractor and ALERE (the "ALERE Representative"). The
ALERE Representative shall (i) be the primary ALERE contact for
Subcontractor with respect to all matters related to this Agreement,
except as otherwise provided in any SOW, (ii) have overall responsibility
for managing and coordinating the performance of the Services, and (iii)
meet regularly (and as frequently as is needed) with the Subcontractor
Representative, and (iv) will have the necessary authority to make
routine decisions with respect to actions to be taken by ALERE under this
DMSA. The ALERE Representative may designate in writing (i) another
individual to be the point of contact for Subcontractor with respect to
the Services to be performed under a particular SOW, and (ii) a
reasonable number of additional employees of ALERE to be points of
contact for Subcontractor with respect to particular matters of expertise
relating to one or more SOWs or particular geographic regions.
2.9 COMPENSATION RECORDS; AUDITS. Subcontractor shall maintain complete and
accurate accounting records in accordance with GAAP as shall be necessary
to substantiate all Service Fees, expense reimbursements or other
Compensation paid under each SOW, (ii) each invoice submitted to or paid
by ALERE(collectively, "Compensation Records"). Subcontractor shall
provide the ALERE with access to all Compensation Records for purposes of
audit or review, either through its own representatives or through an
accounting firm selected and paid for by ALERE; provided, however, that
in the event any
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audit demonstrates that Subcontractor owes ALERE, then such funds and the
costs of the audit, should the amount owed ALERE be greater than
$10,000,shall be subtracted from the next Subcontractor invoice/payment.
Any such audit or review of Compensation Records shall be conducted at
reasonable times during normal business hours and upon reasonable advance
notice.
2.10 NO CONFLICT WITH PERFORMANCE. Under no circumstances shall Subcontractor
engage in any work or undertaking that prevents Subcontractor from fully
performing the Services in accordance with all requirements of this
Agreement and each SOW.
2.11 COOPERATION. Subcontractor shall reasonably cooperate with ALERE, Tufts
and any other vendor (including other disease management vendors) that
any of them may use in connection with this DMSA or the operations of
their Health Plans or other businesses without any additional charge,
unless otherwise agreed by the Parties in writing; provided, however,
that in so cooperating, Subcontractor shall not be required to take or
forebear from taking any action that, absent appropriate safeguards and
contractual protections, adversely affects the confidentiality or
proprietary nature of r any Confidential Information of Subcontractor.
3 PERSONNEL REQUIREMENTS.
3.1 USE OF ACCEPTABLE PERSONNEL. Subcontractor shall make available
appropriate staffing to perform the Services and to monitor and supervise
such performance in accordance with all requirements of each SOW and this
Agreement. Subcontractor shall employ or otherwise contract with
sufficient numbers of trained, competent and qualified individuals as
shall be necessary to perform the Services in accordance with the
requirements of this Agreement and shall assign to the performance of the
Services only personnel who are adequately and appropriately trained,
competent and otherwise qualified to perform the Services. Each
individual performing or supervising Services shall be legally qualified
to be employed and to perform the Services in compliance with all
applicable Laws and Regulations, including, without limitation, United
States immigration laws.
3.2 STAFFING. In the event that ALERE is at any time dissatisfied for any
reason with any of Subcontractor's personnel providing any of the
Services (including the Subcontractor Account Executive), ALERE may give
written notice to Subcontractor, setting forth in reasonable detail the
reason(s) for such dissatisfaction. Upon receipt of ALERE's notice,
Subcontractor will promptly meet with ALERE to determine by mutual
agreement the appropriate course of action to take with respect to such
personnel, which may include, without limitation, discontinuing the use
of such objectionable personnel for the performance of any Services
hereunder. ALERE's rights under this Agreement to object to certain
Subcontractor personnel shall not
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relieve Subcontractor from its obligations to staff, supervise and
monitor all Services in accordance with the requirements of each SOW and
this Agreement.
3.3 TRAINING. Subcontractor, at its sole cost and expense, shall provide
initial and on-going training to its personnel and Contractors who are
engaged in the performance of Services hereunder. Subcontractor promptly
shall incorporate into its training program any training materials
furnished by ALERE, Tufts that may contain information regarding the
Tuft's Health Plans or customer service policies.
3.4 USE OF CONTRACTORS. Except as otherwise provided herein, the consent of
ALERE to any subcontracting of the Services to a Contractor shall not
relieve Subcontractor from its responsibility for the performance of the
Services required to be furnished to ALERE under this Agreement and the
other obligations imposed upon Subcontractor hereunder. If the use of any
other Contractors is approved, Subcontractor shall actively monitor,
review and manage the performance of such Contractors and their
subcontracts on a regular basis.
3.5 OBSERVANCE OF EMPLOYMENT RELATED LAWS. During any period in which
Subcontractor is performing Services for ALERE, Subcontractor shall, and
shall contractually require all Contractors to, comply with all labor and
employment Laws and Regulations in respect of personnel, including,
without limitation, Laws and Regulations relating to wages and hours,
mandatory employee benefits, collective bargaining, unemployment
insurance, workers' compensation, equal employment opportunity,
occupational health and safety, severance and withholding and payment of
social security contributions and employment taxes.
3.6 TRANSLATION. In the event translation services are necessary or
appropriate to communicate with Members in connection with the
performance of the Disease Management Services under this Agreement,
Subcontractor shall be responsible for obtaining all such translation
services so that Subcontractor may properly communicate with such
Members. Subcontractor shall be solely responsible for all costs of such
translation services.
4 LOCATIONS OF SERVICES.
SERVICE LOCATIONS. Subcontractor shall perform the Services at the
locations established in the applicable SOWs (the "Service Locations").
In the event that Subcontractor or a Contractor relocates to another
location or migrates all or any portion of the Services to another
location, (i) Subcontractor shall be responsible for all costs associated
with such relocation or migration, (ii) to the extent ALERE must incur
any costs associated with the relocation or migration, Subcontractor
shall reimburse ALERE for the amount of such costs
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within thirty (30) days after receipt of written demand therefore, (iii)
Subcontractor shall continue to perform all Services, directly or through
arrangements with Authorized Contractors, in accordance with the
requirements of applicable SOWs and this Agreement without reduction of
any service level standard, and (iv) such relocation or migration shall
not disrupt or interfere with the operation of the ALERE's business, the
Health Plans or Tuft's business.
SAFETY AND SECURITY PROCEDURES. Subcontractor shall maintain and enforce
at the Service Locations reasonable and appropriate safety and security
procedures, with respect to the Subcontractor Systems and the storage and
transmission of Tufts Data. Subcontractor shall adopt current industry
standards and practices to safeguard the security, confidentiality and
integrity of Tufts Data (including PHI) located on or transmitted through
the Subcontractor Systems. The safety and security procedures for
telecommunications operations used in the transmission of any Tufts Data
by Subcontractor or its Contractors shall protect the Tufts Data and
other information of Tufts, and the Members from unauthorized access.
4.1 -COMPLIANCE WITH PRIVACY, CONFIDENTIALITY AND SECURITY LAWS. Without
limiting the generality of any other provision of this Agreement,
Subcontractor, at its sole cost and expense, shall comply with, shall
cause its Contractors comply with, and shall cause the Subcontractor
Systems and all electronic or other transactions processed in connection
with the Services (whether by Subcontractor or a Contractor) comply with
all applicable provisions of: (i) HIPAA and the HIPAA Regulations; (ii)
the GLB, if applicable; (iii) the HCFA Internet Security Policy; (iv) any
other current or, when applicable, future Laws and Regulations relating
to the privacy, confidentiality, security, integrity, transmission or
exchange of Tufts Data, PHI or medical, personal, consumer or financial
information of Members, including, but not limited to, Laws and
Regulations relating to the maintenance, use, transmission (by any
means), exchange or other activity concerning patient records,
confidentiality of medical data, the security and protection of PHI; (v)
any other applicable privacy, security or electronic data transmission
standards included within HIPAA and the HIPAA Regulations, and (vi) any
business associate agreement or trading partner agreement entered into
between Subcontractor and ALERE or with any Authorized Contractor in
connection with this Agreement or otherwise. Subcontractor shall comply
at all times (during and after the Term) with all requirements of the
Business Associate Agreement, in the form attached to this DMSA as
EXHIBIT C, and shall cause any Contractor to execute a business associate
agreement in the same form if such Contractor may have access to or may
be exposed to PHI or if directed by ALERE. Upon ALERE's request,
Subcontractor shall enter into, and shall cause any Contractor to enter
into, such updated, amended or modified form of Business Associate
Agreement as ALERE may require or adopt for use with its vendors and
business associates.
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0 XXXXXXXXXXX XXXXXXX; SERVICE LEVEL STANDARDS; MEMBER GRIEVANCES.
5.1 SERVICE LEVEL STANDARDS AND PERFORMANCE TARGETS. Subcontractor agrees
that the Disease Management Services shall be performed, by Subcontractor
in a manner that meets or exceeds the Service Level Standards and
Performance Targets, if any, established in each applicable SOW and
Annual Plan. Subcontractor acknowledges and agrees that Service Level
Standards and Performance Targets may be specific to and different for
each SOW, each Health Plan, and each different Disease Management Service
to be performed, directly or indirectly, by Subcontractor hereunder.
Subcontractor acknowledges and agrees that, unless otherwise specified in
a SOW, meeting all Service Level Standards and Performance Targets is a
material obligation under this Agreement and that the failure to satisfy
Service Level Standards or failure to reach Performance Targets, by
Subcontractor or any Contractor, may result in the termination by ALERE
of all or part of this Agreement or any applicable SOW as specifically
permitted in this Agreement or applicable SOW.
5.2 ANNUAL PLAN. The Parties shall establish a mutually acceptable annual
plan establishing the goals and Performance Targets applicable to the
performance of Disease Management Services under each SOW (the "Annual
Plan"). The Parties shall work cooperatively and in good faith to
establish an Annual Plan no later than thirty (30) days prior to the
commencement of each annual period under any outstanding SOW commencing
on the anniversary date of the SOW Effective Date.
5.3 MEMBER AND PROVIDER GRIEVANCE PROCEDURES. Subcontractor shall use
reasonable business efforts to assist ALERE and/or Tufts in the handling
of Member complaints, grievances and appeals, consistent with the
involved Member Appeal and Grievance Procedures, to the extent they arise
out of this Agreement or any Services. In the event that an oral or
written complaint, grievance or appeal is presented to Subcontractor,
Subcontractor will immediately deliver such complaint, grievance or
appeal to ALERE for handling. Subcontractor shall comply with all final
determinations made by Tufts through the involved Member Appeal and
Grievance Procedures. Member claims against Subcontractor, other than
claims for benefits under the Health Plans, are not subject to the Member
Appeals and Grievances Procedures and are not governed by this DMSA.
6 QUALITY STANDARDS AND CONTINUOUS IMPROVEMENT. Subcontractor, in
cooperation with ALERE and subject to ALERE's reasonable satisfaction,
shall as part of the Services as defined under the SOW or any future
mutually agreeable standards, develop and implement quality improvement
standards, monitoring programs and protocols with respect to the Disease
Management Services.
7 COMPENSATION FOR SERVICES.
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7.1 SERVICE FEES. All provisions for billing and payment of Service Fees and
expense reimbursement for the Services to be furnished to ALERE under
this Agreement will be set forth in the SOW (including any fee schedule
attached thereto) applicable to the Services and Tufts Affiliate for
which such compensation and reimbursement is made; provided, however,
that, in all cases, payment of the Service Fees and expense reimbursement
is conditioned upon timely and satisfactory delivery of the Services in
accordance with the SOW to which such Service Fees relate and the other
requirements of this Agreement.
7.2 DISPUTED AMOUNTS. ALERE shall be permitted to withhold payment of any
amounts, invoiced to or otherwise payable by ALERE pursuant to this
Agreement that ALERE, in good faith, disputes or contests ("Disputed
Amounts"), either by deducting the Disputed Amount from ALERE's payment
on such invoice or payment due or by recouping the Disputed Amount
against future Service Fees or other amounts owing for Services furnished
or arranged by Subcontractor pursuant to this Agreement. However, Dispute
Amounts may only be withheld and deducted by ALERE to the extent that the
aggregate amounts so withheld do not at any time exceed twenty-five
percent (25%) of the total annual aggregate compensation payable to
Subcontractor pursuant to this Agreement (if ALERE wishes to dispute a
greater amount, it shall pay the disputed invoices and refer the matter
to arbitration hereunder) and ALERE has delivered to Subcontractor
written notice (a "Payment Dispute Notice") setting forth a detailed
explanation of the factual basis for the dispute. To contest any such
withheld, offset or recouped amounts, Subcontractor shall, within ten
(10) business days following receipt of the Payment Dispute Notice,
provide the ALERE Representative with a detailed written explanation of
the factual basis upon which Subcontractor, in good faith, contests the
Payment Dispute Notice. Thereafter, the Parties shall negotiate in good
faith to resolve all issues raised by the Payment Dispute Notice. In the
event that ALERE and Subcontractor are unable to resolve the dispute
within ten (10) business days following from the date of Subcontractor's
response, either Party may proceed to arbitration as provided herein.
Subcontractor acknowledges that all recoupment, withhold and offset
rights authorized by this Agreement shall be deemed to be and to
constitute rights of recoupment authorized in state or federal law or in
equity to the maximum extent possible under law or in equity and that
such rights shall not be subject to any requirement or prior or other
approval from any court or other Government Authority that may now or
hereafter have jurisdiction over ALERE or Subcontractor.
7.3 ADEQUATE COMPENSATION. Subcontractor hereby agrees that its execution of
any SOW or commencement of any Services contemplated therein shall
constitute Subcontractor's agreement that any Service Fees or other
compensation, expense reimbursements or other amounts owing to
Subcontractor in respect of the Services or Deliverables described in
such SOW (i) are adequate and appropriate for such Services or
Deliverables, (ii)
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will be accepted by Subcontractor in full and complete satisfaction and
discharge of any and all monetary or non-monetary obligations owed to
Subcontractor by ALERE in respect of such Services and Deliverables and
(iii) represent the reasonable and fair market value for the Services and
Deliverables being furnished by Subcontractor pursuant to such SOW.
Nothing contained in this Agreement or in any SOW shall confer upon
Subcontractor any right, in consideration or in respect of any Services
or Deliverables, to receive additional amounts, benefits, profits or
other economic consideration derived from ALERE's present or prospective
operations or from any present or prospective venture, enterprise or
business in which ALERE now or hereafter may engage.
7.4 PASS-THROUGH EXPENSES. Any pass-through expenses of Subcontractor that
will be the financial responsibility of ALERE must be expressly
identified in a SOW, shall remain subject to the prior written approval
of ALERE, and shall be reimbursed by ALERE at the actual cost thereof to
Subcontractor without any markup.
7.5 TAXES. Each Party shall be responsible for all Taxes and other charges
levied on its business or product(s). Subcontractor shall pay, or
reimburse and indemnify ALERE, for all Taxes imposed in connection with
Subcontractor's provision of the Services, excluding Taxes based upon
ALERE's gross or net income.
8 REPRESENTATIONS, WARRANTIES AND COVENANTS.
Subcontractor represents, warrants and covenants to ALERE as follows:
8.1 AUTHORITY. Subcontractor has the full power and authority to enter into
this DMSA and will have the full power and authority to enter into every
SOW executed by Subcontractor and to perform all Services and comply with
all terms and satisfy all conditions set forth in this DMSA. This DMSA
and each current and future SOW will be executed by a duly authorized
representative of Subcontractor and, when so executed, shall constitute
the valid and binding obligation of Subcontractor, enforceable against
Subcontractor in accordance with its terms, subject to applicable
bankruptcy, insolvency, reorganization and other laws of general
applicability relating to or affecting creditors' rights and to general
equity principles.
8.2 LICENSURE. Subcontractor will maintain throughout the Term all licenses,
permits, certificates, approvals, authorizations, registrations,
accreditations and qualifications (collectively, "Authorizations")
necessary for Subcontractor to provide the Services and Deliverables
pursuant to this DMSA, and all such Authorizations shall be and remain
valid, subsisting and in good standing during the Term. In addition to
the Authorizations required by the preceding sentence, Subcontractor is
and shall remain during the Term duly and validly licensed, approved,
authorized, registered, accredited and qualified to do
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business and in good standing in every jurisdiction in which any
Authorization is required for the ownership or leasing of its assets and
the transaction of business of the character transacted by it, including,
without limitation, the performance of the Services and furnishing of the
Deliverables as required hereunder. No approval, authorization or consent
of any Governmental Authority is or shall be required for Subcontractor
to enter into and perform its obligations under this Agreement that has
not been obtained prior to the Effective Date or the applicable SOW
Effective Date.
8.3 PERFORMANCE OF SERVICES. Subcontractor possesses and shall maintain
staffing and administrative capacity, and financial, operational and
information technology resources (collectively, "Capacity and Resources")
necessary to perform all Services under this Agreement in accordance with
the terms and conditions hereof. All Services shall be performed or
delivered (i) in a good, professional and workmanlike manner by personnel
who are fully qualified and competent to perform or deliver such
Services, without the advice, control or supervision of ALERE, (ii) in
accordance with generally accepted professional and technical standards
applicable to such Service; and (iii) in accordance with all Laws and
Regulations and requirements of Governmental Authorities applicable to
them. No Services or Deliverables shall infringe upon or violate any
Intellectual Property Rights of a Third Party.
8.4 RIGHTS IN PRE-EXISTING INTELLECTUAL PROPERTY. To the extent that the
performance of any Service or delivery of any Deliverable under this
Agreement involves Subcontractor's license or assignment to ALERE of
Pre-Existing Intellectual Property, (i) Subcontractor owns or has
sufficient legal rights in and to the Pre-Existing Intellectual Property
to perform all such Services and deliver all such Deliverables; (ii)
Subcontractor has all requisite power, authority and legal rights to
license or assign such Pre-Existing Intellectual Property to ALERE as
shall be necessary for ALERE to use the Services or Deliverables
furnished by Subcontractor without limitation or restriction and without
infringing upon or violating the Intellectual Property Rights of any
Third Party; and (iii) ALERE's or Tuft's use of any IT Development Work
or other Deliverable will not result in any additional fees, charges,
licenses or penalties payable by ALERE or Tufts.
8.5 VIRUSES; DISABLING CODES. To the best of its ability (which shall include
no less than commercially reasonable efforts), Subcontractor will ensure
that no software (including any Subcontractor interfaces facilitating
transmission of data between Subcontractor, Tufts, and/or ALERE)
furnished or developed by Subcontractor in respect of any IT Development
Work or licensed, assigned or used in connection with any Services or
Deliverables will contain any "virus" or other computer software routine
or hardware components which are designed to (i) permit any unintended
Third Party access to or use of any software or systems developed for
ALERE or Tufts to their systems, (ii) disable or damage hardware or
damage, erase or delay access to software or data or (iii) perform any
other similar destructive or malicious actions.
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With respect to the development or use of any software (including any
Subcontractor interfaces facilitating transmission of data between
Subcontractor, Tufts, and/or ALERE) or software systems in connection
with Subcontractor's performance and delivery of any Services or
Deliverables (including, without limitation, in connection with the
Subcontractor Systems), Subcontractor will not, nor permit any employee
or Contractor to, insert into such software or systems any code or other
device which would have the effect of disabling, damaging, erasing,
delaying or otherwise shutting down all or any hardware, software,
systems or data belonging to, claimed by or in the possession of Tufts or
Alere. Subcontractor will not invoke, and will use all commercially
reasonable efforts to prevent any employee or Contractor from invoking,
any such code or other device.
8.6 PASS-THROUGH WARRANTIES AND INDEMNITIES. In connection with the Services
performed under any SOW or this Agreement, Subcontractor hereby assigns
and passes through to ALERE, and Tufts any representations, warranties,
indemnities or other rights or protections (collectively, "Warranties")
which from time to time may inure to Subcontractor from owners, vendors
or licensors of any Pre-Existing Intellectual Property, from owners,
vendors or lessors of equipment or from Contractors, to the full extent
of such Warranties. All such Warranties that relate to any products or
services that comprise part of any Services or Deliverables shall be
reasonably acceptable to ALERE. To the extent that any such Warranties
cannot be assigned or passed through as provided, Subcontractor shall
take all commercially reasonable steps to enforce such rights and seek
appropriate remedies in Subcontractor's own name for the benefit of the
other parties.
ALERE represents, warrants and covenants to Subcontractor as follows:
8.7 AUTHORITY. ALERE has the full power and authority to enter into this DMSA
and will have the full power and authority to enter into every SOW
(unless ALERE determines that any particular SOW or SOWs must be executed
separately by a particular Tufts Affiliate) and comply with all terms and
satisfy all conditions set forth in this Agreement. This DMSA and each
current and future SOW will be executed by a duly authorized
representative of ALERE and, when so executed, shall constitute the valid
and binding obligations of ALERE, enforceable in accordance with their
terms, subject to applicable bankruptcy, insolvency, reorganization and
other laws of general applicability relating to or affecting creditors'
rights and to general equity principles.
8.9 COOPERATION. ALERE shall use reasonable business efforts to facilitate
the performance by Subcontractor of the Services under this DMSA and any
SOW, and ALERE, through its arrangements with Tufts, shall cause Tufts to
provide all information and take all actions necessary for Subcontractor
to provide its Services hereunder.
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9 INFORMATION AND TELECOMMUNICATIONS TECHNOLOGY AND EQUIPMENT. Except as
expressly provided to the contrary in any SOW, Subcontractor shall, at
its sole cost and expense, provide, obtain and maintain all
telecommunications service, equipment, hardware, lines and line usage
necessary or appropriate for provision of the Services. In the event that
ALERE is responsible for paying for any telecommunications services or
equipment in connection with the Services, ALERE shall have the right to
pre-approve the telecommunications service provider and the rates payable
by ALERE, which rates shall be set forth in a SOW executed by ALERE. Any
hardware or other fixed assets provided or paid for by ALERE for
installation at Subcontractor's premises shall remain the sole property
of ALERE and shall be returned to ALERE at its request or upon the
expiration or earlier termination of this DMSA or applicable SOW.
Subcontractor shall not make any changes or modifications to, or
substitutions for, such ALERE purchased or provided hardware or fixed
assets without the prior consent of ALERE, which consent may be given or
withheld in ALERE's sole discretion.
10 CHANGE ORDER PROCESS. ALERE may request that Subcontractor make material
changes to a SOW by giving written notice to Subcontractor setting forth
in reasonable detail all requested changes (a "Change Order Request").
Within seven (7) business days (or such longer period as the Parties may
agree in writing) after Subcontractor's receipt of a Change Order
Request, Subcontractor shall provide ALERE with a written proposal (a
"Change Order Proposal") setting forth in reasonable detail all changes
necessary to effect or that may result from the Change Order Request,
including, without limitation, modifications to Services, Service Level
Standards or Performance Targets, the additional cost for or cost savings
from effecting the requested changes (if any), the time required to
effect the Change Order Request, and any reasonably foreseeable
consequences to Members, Services or the Parties resulting from effecting
the Change Order Request. Subcontractor shall not initiate any change
pursuant to a Change Order Request until the Parties memorialize all
agreed-upon portions of the Change Order Proposal in a written amendment
to the applicable SOW or in a new SOW, at which time such amendment or
new SOW shall become a part and subject to all of the terms and
conditions of this DMSA. Notwithstanding the foregoing, the following
changes requested by ALERE shall not be subject to the change order
requirements of this Section, and shall be effected by Subcontractor as
expeditiously as possible (but no later than thirty (30) days) following
request by ALERE: (i) immaterial changes to the Services, Service Level
Standards or Performance Targets mutually agreed to by the Parties; and
(ii) changes necessary to bring the Services in compliance with
applicable Laws and Regulations (including, without limitation, Privacy
Laws), standards of Accreditation Organizations; provided that
Subcontractor may, in lieu of making the changes set forth in (ii) above,
Subcontractor may elect to terminate the Agreement by giving Alere not
less than thirty (30) days prior written notice of termination.
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11 PROTECTION OF INFORMATION; NONSOLICITATION. The Parties agree as follows:
11.1 CONFIDENTIALITY OBLIGATIONS OF THE PARTIES. Each of Subcontractor and
ALERE (each, a "Receiving Party") receiving or having access to
Confidential Information of the other Party (or in Subcontractor's case,
the Confidential Information of Tufts) (the "Disclosing Party") shall use
commercially reasonable efforts to protect and maintain the
confidentiality and, to the extent applicable, proprietary character, of
such Disclosing Party's Confidential Information by, among other things:
(i) treating such information with at least the same standard of care and
protection that the Receiving Party accords its own Confidential
Information, which shall be no less than a commercially reasonable
standard; (ii) using great care in the assignment of personnel and
contractors who have access to Confidential Information and obtaining the
written agreement of all such personnel and contractors to take all
reasonable precautions to prevent unauthorized use or disclosure thereof;
(iii) not using, disclosing or exploiting such Confidential Information
except as reasonably necessary to perform its duties and obligations
under a SOW or this Agreement; and (iv) complying with any Laws and
Regulations applicable to the Confidential Information, including
following directives or recommendations from Governmental Authorities
exercising jurisdiction over, or Accreditation Organizations adopting
standards for ALERE, Tufts, the Health Plans, the Services or the Service
Location(s). Furthermore, no Receiving Party shall disclose, publish,
release, transfer or otherwise make available Confidential Information of
the Disclosing Party in any form whatsoever to, or for the use or benefit
of, the Receiving Party or a Third Party without the Disclosing Party's
prior written consent; provided, however, that a Receiving Party may
disclose relevant aspects of the Disclosing Party's Confidential
Information to the Receiving Party's officers, agents, subcontractors and
employees and to the officers, agents, subcontractors and employees of
its Affiliates to the extent that such disclosure is reasonably necessary
for the performance of the Receiving Party's duties and obligations under
this Agreement; provided, further, that the Receiving Party shall take
all reasonable measures to ensure that Confidential Information of the
Disclosing Party is not disclosed or duplicated in contravention of the
provisions of this DMSA by such Persons; and provided, further, that the
Receiving Party shall be responsible for any breach of the provisions of
this Section by such Persons. The obligations imposed on the Parties in
this Section shall not restrict disclosures made by the Receiving Party
that are compelled by applicable Laws and Regulations (including
disclosures required by CMS or other Governmental Authorities in
connection with an audit, investigation or otherwise), court order or the
order of a Governmental Authority with competent jurisdiction over the
Receiving Party; provided that the Receiving Party being compelled to
disclose any such information shall give prompt notice thereof after
learning of the need therefore to the Disclosing Party (if allowed by
law) and shall disclose only that portion of the Disclosing Party's
Confidential Information which the
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Receiving Party's outside legal counsel advises is necessary to comply
with such Laws and Regulations, court order or Governmental Authority
order.
11.2 DETERMINATION OF CONFIDENTIAL INFORMATION. As used in this DMSA, the term
"Confidential Information" shall mean: (i) the existence and terms
(including, but not limited to, the pricing terms) of this DMSA and all
SOWs, which shall be confidential to both Parties; (ii) all material,
non-public information, materials or data in any form (whether disclosed
before or after the Effective Date or whether oral, written, graphic,
electronic, visual or fixed in any other tangible medium of expression)
which the Receiving Party knows or has reason to know is confidential or
proprietary to the Disclosing Party or its Related Party; (iii) any other
information which is clearly marked or designated as "Confidential,"
"Proprietary" or "Secret" by the Disclosing Party or a Related Party
thereof; (iv) the trade secrets, know how, technology, inventions
(whether or not patented), software programs, source or object codes,
algorithms, technical drawings, schematics, formulae and technology plans
and specifications (whether, in the case of any of the foregoing, they
are owned, licensed or used by the Disclosing Party); and (v) current and
future business plans, marketing plans and strategies, business methods
and practices, business workflows and rules, matrices, customer or
prospect data, records, information and profiles, supplier or vendor
information and data, historical or prospective financial information,
budgets, cost and expense data and employment records and contracts and
personnel information of the Disclosing Party or of its Related Parties.
Notwithstanding the foregoing provisions of this Section, "Confidential
Information" shall not include any information (1) after it has become
generally available to the public through no fault of the Receiving Party
and without a breach of this Agreement, or (2) which can be demonstrated
by the Receiving Party was developed independently or in its possession
prior to entering into this DMSA so long as, in either case, the
Receiving Party did not acquire such information from a source which had
a fiduciary, confidential or contractual duty to the Disclosing Party to
maintain such information as confidential.
11.3 CONFIDENTIALITY OF PATIENT RECORDS AND PHI. Subcontractor acknowledges
that, in the performance of the Services, Subcontractor will have access
to Member-identifiable information and PHI which is transmitted via or
obtained through Subcontractor's performance of the Services, or stored
on, or accessible via, the Subcontractor Systems. Subcontractor
understands that such identifiable information and PHI are protected by
various state and Federal Laws and Regulations, including, but not
limited to, the HCFA Internet Security Policy, HIPAA and the HIPAA
Regulations (collectively, all such state and Federal Laws and
Regulations, "Privacy Laws"). Subcontractor understands and agrees that
any medical information or PHI accessed by or disclosed to it or its
Contractors during the course of performing any Services or otherwise
must be maintained in strictest confidence. Accordingly, except as
absolutely necessary to provide the Services and permitted by the
Business Associate Agreement, Subcontractor
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shall not disclose (except to ALERE and Tufts), divulge, use or
commercially or otherwise exploit any such medical information or PHI for
any purpose or under any circumstance, and shall comply with all state
and Federal Laws and Regulations applicable to Subcontractor regarding
the security, confidentiality and transmission of such information
including, but not limited to, the Privacy Laws (including those rules,
regulations and standards that Tufts , as a Covered Entity (as defined in
HIPAA), must impose upon ALERE and/or Subcontractor, as a Business
Associate (as defined in HIPAA)). Subcontractor shall require all of its
personnel and to contractually require all of its Contractors to fully
abide by the provisions of this Section and Subcontractor shall be
responsible for any breach by its personnel or Contractors of this
Section. In the event of a breach of the provisions of this Section,
ALERE may terminate this DMSA and any and all SOWs as provided in Section
13.2.4.
11.4 RETURN OF CONFIDENTIAL INFORMATION. Upon termination of this DMSA for any
reason whatsoever or at any time upon the Disclosing Party's request, the
Receiving Party immediately shall return all Confidential Information of
the Disclosing Party within the possession or control of the Receiving
Party or its personnel, Related Parties or Contractors. In the event that
any Confidential Information is contained in analyses, compilations,
studies or other documents prepared by the Receiving Party, its
personnel, its Related Parties or its Contractors, the Receiving Party
agrees to promptly destroy, and to instruct its personnel, Related
Parties and Contractors to destroy, all such items where feasible, and
certify in writing to the Disclosing Party that such destruction has
occurred. To the extent that the Receiving Party is required to retain
the Confidential Information to comply with any record retention
requirement set forth herein or to comply with (i) any standard of an
Accreditation Organization applicable to ALERE, Subcontractor or Tufts,
or (ii) any Laws and Regulations, the Receiving Party shall so notify the
Disclosing Party; in such event, the Receiving Party may retain the
Confidential Information solely for such purposes and the Confidential
Information shall remain subject to the restrictions on use and
disclosure set forth herein until returned to the Disclosing Party or
destroyed.
11.5 SURVIVAL. The provisions of this Section shall survive the expiration or
termination of any SOW and this DMSA.
12 INTELLECTUAL PROPERTY RIGHTS. The Parties agree as follows:
12.1 ALERE MARKS AND CONTENT. Alere owns and shall remain the sole and
exclusive owner of all right, title and interest in and to the Alere
Marks and Alere Content, and of all Intellectual Property Rights in and
derivative works of the Alere Marks and the Alere Content. Subcontractor
is not granted any right or license to, and shall not use, the Alere
Marks or Alere Content in any manner or for any purpose except as may be
agreed in writing in advance by Alere (including in any SOW).
Subcontractor agrees not to assert any rights
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in or to any Alere Marks or Alere Content except as granted to
Subcontractor pursuant to this Agreement or as otherwise may be granted
in writing by Alere to Subcontractor. Without express prior written
authorization from ALERE, Subcontractor shall not use any Alere Marks or
other words or phrases identifying Alere or any Alere Affiliate in any
promotional or other materials of Subcontractor nor otherwise publicly
identify ALERE or refer to the existence or terms of this Agreement in
any public announcement, press release, promotional or other material.
12.2 SUBCONTRACTOR MARKS AND CONTENT. Subcontractor owns and shall remain the
sole and exclusive owner of all right, title and interest in and to the
Subcontractor Marks and Subcontractor Content, and of all Intellectual
Property Rights in and derivative works of the Subcontractor Marks and
the Subcontractor Content. Alere is not granted any right or license to,
and shall not use, the Subcontractor Marks or Subcontractor Content in
any manner or for any purpose except as may be agreed in writing in
advance by Subcontractor (including in any SOW). Alere agrees not to
assert any rights in or to any Subcontractor Marks or Subcontractor
Content except as granted to Alere pursuant to this Agreement or as
otherwise may be granted in writing by Subcontractor. Without express
prior written authorization from Subcontractor, ALERE shall not use any
Subcontractor Marks or other words or phrases identifying Subcontractor
in any promotional or other materials of Subcontractor nor otherwise
publicly identify Subcontractor or refer to the existence or terms of
this Agreement in any public announcement, press release, promotional or
other material for any other purpose.
12.3 TUFTS MARKS AND CONTENT. Tufts owns and shall remain the sole and
exclusive owner of all right, title and interest in and to the Tufts
Marks and Tufts Content, and of all Intellectual Property Rights in and
derivative works of the Tufts Marks and the Tufts Content. Subcontractor
is not granted any right or license to, and shall not use, the Tufts
Marks or Tufts Content in any manner or for any purpose except (i) as
necessary to perform the Services and to communicate with third parties
on Tuft's behalf as directed by Tufts or Alere, and (ii) as may be agreed
in writing (including in any SOW) in advance by Tufts. Except as granted
to Subcontractor in this Agreement, Subcontractor shall not assert any
rights in or to any Tufts Marks or Tufts Content. Any and all uses of the
Tufts Marks and Tufts Content by Subcontractor in connection with the
Services or otherwise shall inure to the sole benefit of Tufts. Without
express prior written authorization from Tufts, Subcontractor shall not
use any Tufts Marks or other words or phrases identifying Tufts or any
Tufts Affiliate in any promotional or other materials of Subcontractor
nor otherwise publicly identify Tufts or refer to the existence or terms
of this Agreement in any public announcement, press release, promotional
or other material.
12.4 ALERE DEVELOPED MATERIALS. Alere shall be the sole and exclusive owner of
all rights in and to any of the Alere Developed Materials. In the event
that
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Subcontractor participates in the making, creation, authorship,
conception or development of any Alere Developed Materials, such Alere
Developed Materials shall be considered a "work made for hire" to the
fullest extent permitted by the U.S. Copyright Act. However, without
further consideration, upon execution of this Agreement, Subcontractor,
on behalf of itself and its personnel and agents, hereby fully and
irrevocably assigns, transfers and conveys to Alere all of the right,
title and interest of Subcontractor in and to the Alere Developed
Materials (whether or not a work made for hire) effective automatically
upon the development, creation, authorship or inception of any Alere
Developed Materials, together with all Intellectual Property Rights in or
to such Alere Developed Materials and derivative works thereof.
Subcontractor shall cause any of its personnel involved in any Alere
Developed Materials to execute any assignments, conveyances, documents of
transfer or releases to give full legal effect to such assignment and
conveyance of their respective rights or interests (if any) in any Alere
Developed Materials or to otherwise fully effectuate Alere's exclusive
ownership rights in and to the Alere Developed Materials and any
derivative works thereof. Subcontractor agrees not to assert any rights
in or to any Alere Developed Materials or their Intellectual Property
Rights except as may be expressly granted by this Agreement.
Subcontractor, on behalf of itself and its Affiliates, shareholders,
predecessors, successors, successors-in-interest, assigns, directors,
employees, contractors and agents, hereby forever and fully releases and
discharges Alere from any known or unknown, foreseeable or unforeseeable
claims, demands, lawsuits, causes of action or payments arising from any
rights or ownership which they now or hereafter may allege in or to any
of the Alere Developed Materials or the Intellectual Property Rights
therein. It is expressly understood that Section 1542 of the Civil Code
of California provides as follows:
"A general release does not extend to claims which the creditor does not
know or suspect to exist in his favor at the time of executing the
release, which if known by him must have materially affected his
settlement with the debtor."
The provisions of said Section 1542 of the Civil Code of California, as
well as the provisions of all comparable, equivalent or similar statutes
and principles of common law of California and of other states of the
United States, are hereby waived by Subcontractor.
Notwithstanding the foregoing, the Parties expressly agree that
Subcontractor shall be entitled to use and reproduce, on a royalty-free
basis, any of the Alere Developed Materials in connection with
Subcontractor's performance of its duties, obligations and
responsibilities under this Agreement.
12.5 SUBCONTRACTOR DEVELOPED MATERIALS. Subcontractor shall be the sole and
exclusive owner of all rights in and to any of the Subcontractor
Developed Materials. In the event that Alere participates in the making,
creation, authorship, conception or development of any Subcontractor
Developed Materials, such Subcontractor Developed Materials shall be
considered a
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"work made for hire" to the fullest extent permitted by the U.S.
Copyright Act. However, without further consideration, upon execution of
this Agreement, Alere, on behalf of itself and its personnel and agents,
hereby fully and irrevocably assigns, transfers and conveys to
Subcontractor all of the right, title and interest of Alere in and to the
Subcontractor Developed Materials (whether or not a work made for hire)
effective automatically upon the development, creation, authorship or
inception of any Subcontractor Developed Materials, together with all
Intellectual Property Rights in or to such Subcontractor Developed
Materials and derivative works thereof. Alere shall cause any of its
personnel involved in any Subcontractor Developed Materials to execute
any assignments, conveyances, documents of transfer or releases to give
full legal effect to such assignment and conveyance of their respective
rights or interests (if any) in any Subcontractor Developed Materials or
to otherwise fully effectuate Subcontractor's exclusive ownership rights
in and to the Subcontractor Developed Materials and any derivative works
thereof. Alere agrees not to assert any rights in or to any Subcontractor
Developed Materials or their Intellectual Property Rights except as may
be expressly granted by this Agreement. Alere, on behalf of itself and
its Affiliates, shareholders, predecessors, successors,
successors-in-interest, assigns, directors, employees, contractors and
agents, hereby forever and fully release and discharge Subcontractor from
any known or unknown, foreseeable or unforeseeable claims, demands,
lawsuits, causes of action or payments arising from any rights or
ownership which it now or hereafter may allege in or to any of the
Subcontractor Developed Materials or the Intellectual Property Rights
therein. It is expressly understood that Section 1542 of the Civil Code
of California provides as follows:
"A general release does not extend to claims which the creditor does not
know or suspect to exist in his favor at the time of executing the
release, which if known by him must have materially affected his
settlement with the debtor."
The provisions of said Section 1542 of the Civil Code of California, as
well as the provisions of all comparable, equivalent or similar statutes
and principles of common law of California and of other states of the
United States, are hereby waived by Alere.
Notwithstanding the foregoing, it is expressly agreed that Alere shall be
entitled to use and reproduce, on a royalty-free basis, any of the
Subcontractor Developed Materials in connection with Alere's performance
of its duties, obligations and responsibilities under this Agreement.
12.6 SURVIVAL. The provisions of this Section 12 shall survive the expiration
or termination of any SOW and this DMSA.
13 TERMINATION OF AGREEMENT.
13.1 TERM AND DURATION. The initial term of this DMSA shall commence on the
Effective Date and continue for a period of one (1) year thereafter until
12:00
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midnight on the last day of such period (the "Initial Term") unless
terminated earlier pursuant to the provisions of this Section or as
permitted elsewhere in this DMSA. Any termination or nonrenewal of this
DMSA shall terminate the entire Agreement, including all then-outstanding
SOWs; provided, however, that any provisions contained in this DMSA
(including, without limitation any SOW) that expressly survive
termination of this DMSA shall survive any such termination or
nonrenewal.
13.2 TERMINATION OF DMSA OR SOW.
13.2.1 FOR CAUSE. In the event that either ALERE or Subcontractor (i) fails or
is unable to perform the obligations, duties or responsibilities required
of it under any SOW or this Agreement, (ii) otherwise violates a material
term of this Agreement, or (iii) engages in conduct in connection with
this Agreement or any Services that is grossly negligent or amounts to
willful misconduct (each a "Default"), the non-Defaulting Party, at its
election, may terminate either this DMSA (in its entirety) or the
applicable SOW, by giving thirty (30) days prior written notice to the
Defaulting Party (a "Default Notice"). Any Default Notice provided
hereunder shall specify in reasonable detail the nature of the Default,
the actions required to cure the Default if it is curable, and whether
the non-Defaulting Party is seeking to terminate the entire DMSA or only
the applicable SOW(s). If the Defaulting Party fails or is unable to cure
the Default to the reasonable satisfaction of the non-Defaulting Party
within thirty (30) days following the date of the Default Notice, then
this DMSA or the applicable SOW, as the case may be, shall be terminated
upon the expiration of said 30-day period, or at such later date as may
be specified in the Default Notice.
13.2.2 AUTOMATIC TERMINATION. To the fullest extent permitted by applicable Laws
and Regulations, this DMSA shall automatically terminate, without the
need for any further act, deed or notice by either Party upon the
occurrence of a Bankruptcy Event or Business Cessation Event affecting
Subcontractor or ALERE.
13.2.3 IMMEDIATE TERMINATION. Notwithstanding the provisions of Section 13.2.1
above, either party may terminate this DMSA immediately by giving written
notice to the other in the event that the other party fails or is unable
to fully comply with its obligations under Section 11 or 12 of this DMSA
provided, however, termination as a result of violation of the Business
Associate Agreement shall be governed by the termination provisions
therein.
13.2.4 ADVERSE LEGAL DETERMINATION. Subject to the provisions of Section 27 of
this DMSA and the Parties' obligations thereunder, either Subcontractor
or ALERE may terminate this DMSA or the affected SOW immediately upon the
giving of written notice to the other Party following a
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Judgment, an order of a court or Governmental Authority or a change in
any Laws or Regulations (including a change in the interpretation or
enforcement of existing Laws or Regulations) that would make (based upon
a reasonably, good faith legal determination) such Party's continued
performance of its obligations under this DMSA or such SOW unlawful,
illegal or commercially impracticable.
13.3 EFFECTS OF TERMINATION. The termination of this DMSA shall not affect the
continued enforceability of the provisions of this DMSA that survive such
termination and any other provisions necessary to interpret or construe
such provisions. The termination of any SOW (without termination of this
DMSA) shall not in and of itself, alter, effect or terminate this DMSA or
any other SOW unless expressly provided in this DMSA or such other SOW.
13.4 TRANSITION ASSISTANCE FOLLOWING TERMINATION. Upon the expiration or
earlier termination of any SOW or this DMSA for any reason whatsoever
other than default by ALERE, (a "Transition Event"), ALERE, at its option
exercised by written notice to Subcontractor (a "Transition Notice"), may
require (i) Subcontractor to continue providing Disease Management
Services ("Continuing Services") for up to one hundred eighty (180) days
following the Transition Event (the "Transition Assistance Period"), and
(ii) Subcontractor to provide such transition assistance, as ALERE may
reasonable require, to transition and transfer the Disease Management
Services under any SOW to ALERE or to another vendor ("Transition
Assistance Services"), the nature and extent of which assistance shall be
as reasonably determined by ALERE, provided, however, that in so
providing such Continuing Services and Transition Assistance Services
following a Transition Event, Subcontractor shall not be required to take
or forebear from taking any action that, absent appropriate safeguards
and contractual protections, adversely affects the confidentiality or
proprietary nature of the Subcontractor Proprietary System or any
Confidential Information of Subcontractor.
13.4.1 Subcontractor shall provide Continuing Services and Transition Assistance
Services in accordance with all applicable Service Level Standards and
Performance Targets and any other applicable provisions of this DMSA.
ALERE shall pay Subcontractor for (i) Continuing Services at the Service
Fees in effect under the applicable SOW(s) at the time of the Transition
Event, and (ii) Transitions Services (other than those required under
13.6) at the applicable Service Fees in effect or, if none, at
Subcontractor's cost. As part of the Transition Assistance Services,
Subcontractor shall cooperate with ALERE and take all actions reasonably
requested by ALERE in order to transition the Services to another vendor
or ALERE, provided, however, that in so cooperating, Subcontractor shall
not be required to take or forebear from taking any action that, absent
appropriate safeguards and contractual protections, adversely affects the
confidentiality or proprietary nature of the Subcontractor Proprietary
System or any Confidential Information of Subcontractor.
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13.4.2 Following the Continuing Services Period, Subcontractor, at no additional
cost, shall continue to answer questions regarding the Services on an "as
needed" basis for up to one hundred (100) days.
13.5 TERMINATION AND BANKRUPTCY. Any rights or licenses granted by
Subcontractor in respect of the Subcontractor Independent Materials or
Pre-Existing Intellectual Property Rights under or pursuant to this DMSA
are and shall otherwise by deemed to be licenses and rights to
"intellectual property" (as defined under Section 101 of the Bankruptcy
Code) for the purposes of Section 365(n) of the Bankruptcy Code. The
Parties agree that the licensee of such rights shall retain and may fully
exercise all of its rights and elections under the Bankruptcy Code during
the Term and following any termination of a SOW or this DMSA. The Parties
further agree that the occurrence of any Bankruptcy Event and the grant
of rights and license provided for in this Section shall not, and shall
not be deemed or construed to, in any way restrict or impair the
termination of this DMSA by ALERE.
CHANGE OF CONTROL. SUBCONTRACTOR SHALL PROVIDE ALERE WITH AT LEAST THIRTY (30)
DAYS PRIOR WRITTEN NOTICE OF A CHANGE OF CONTROL OF SUBCONTRACTOR.
Indemnification and Reimbursement Rights and Obligations.
13.6 MUTUAL COVENANTS. Each Party hereby acknowledges, represents and warrants
to the other that (i) it is a sophisticated business Person that was
represented by legal counsel during the negotiations with respect to this
Agreement, including, without limitation, the negotiations of this
Section 14, (ii) it is fully informed regarding all of the provisions of
this Agreement and all matters addressed herein and (iii) the provisions
of this Section 14 fairly allocate the risks with respect to matters for
which indemnification or reimbursement may be sought under this
Agreement. The provisions of this Section 14 shall survive the expiration
or earlier termination of any SOW or this DMSA.
13.7 ALERE'S INDEMNIFICATION OBLIGATIONS. ALERE shall indemnify, defend and
hold harmless Subcontractor, its Affiliates and their respective owners,
subsidiaries, directors, officers, employees, representatives, agents,
independent contractors, successors, successors-in-interest and assigns
(collectively, the "Subcontractor Indemnitees") from and against, any and
all Claims made by a Third Party against any Subcontractor Indemnitee
arising out of or attributable to (i) any breach or inaccuracy in ALERE's
representations or warranties in this Agreement (including any SOW); (ii)
any failure or inability of ALERE or its personnel or Contractors to
comply with any applicable requirement of this Agreement (including any
SOW), including, without limitation, obligations of ALERE (or such
personnel or Contractors) arising under the Business Associate Agreement;
(iii) any actions or omissions of ALERE or its personnel or Contractors
occurring during or in connection with the performance of any Services,
including, without
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limitation, any harm, injury or death to Persons or damage to property;
(iv) the violation by ALERE or by its personnel or Contractors of any
Laws and Regulations, including any fines, penalties or assessments
imposed upon Subcontractor as a result thereof; (v) the infringement,
misappropriation or violation of the Intellectual Property Rights,
contract rights or tort rights (including the right of publicity or right
of privacy) of any Person arising out of the performance or
non-performance of this Agreement by ALERE or its personnel or
Contractors; or (vi) any compensation, fees, salary, bonuses, mandatory
or fringe employee benefits, social security, employment taxes or other
withholdings that are alleged to be owed in respect of any personnel or
Contractors of ALERE. ALERE shall promptly pay and fully satisfy any and
all Losses, Judgments or Expenses incurred or sustained by Subcontractor
or any Subcontractor Indemnitee as a result of any Claims of the types
described in this Section 14.2.
13.8 SUBCONTRACTOR'S INDEMNIFICATION OBLIGATIONS. Subcontractor shall
indemnify, defend and hold harmless ALERE, its Affiliates and their
respective owners, subsidiaries, directors, officers, employees,
representatives, agents, independent contractors, successors,
successors-in-interest and assigns (collectively, the "ALERE
Indemnitees") from and against, any and all Claims made by a Third Party
against any ALERE Indemnitee arising out of or attributable to (i) any
breach or inaccuracy in Subcontractor's representations or warranties in
this Agreement (including any SOW); (ii) any failure or inability of
Subcontractor or its personnel or Contractors to comply with any
applicable requirement of this Agreement (including any SOW), including,
without limitation, obligations of Subcontractor (or such personnel or
Contractors) arising under the Business Associate Agreement; (iii) any
actions or omissions of Subcontractor or its personnel or Contractors
occurring during or in connection with the performance of any Services,
including, without limitation, any harm, injury or death to Persons or
damage to property; (iv) the violation by Subcontractor or by its
personnel or Contractors engaged by Subcontractor of any Laws and
Regulations, including any fines, penalties or assessments imposed upon
Subcontractor as a result thereof; (v) the infringement, misappropriation
or violation of the Intellectual Property Rights, contract rights or tort
rights (including the right of publicity or right of privacy) of any
Person arising out of the performance or non-performance of this
Agreement by Subcontractor or its personnel or Subcontractor's
Contractors; or (vi) any compensation, fees, salary, bonuses, mandatory
or fringe employee benefits, social security, employment taxes or other
withholdings that are alleged to be owed in respect of any personnel or
Contractors of Subcontractor. Subcontractor shall promptly pay and fully
satisfy any and all Losses, Judgments or Expenses incurred or sustained
by ALERE or any ALERE Indemnitee as a result of any Claims of the types
described in this Section 14.3.
13.9 PROCEDURE FOR HANDLING CLAIMS.
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13.9.1 THIRD PARTY CLAIMS. Promptly after the receipt by either Party of a
notice of a Claim made by a Third Party that is the subject of
indemnification pursuant to this Section 15 (collectively, "Third Party
Claim"), such Party (the "Indemnified Party") shall deliver to the Party
from which indemnification is sought (the "Indemnifying Party") a written
notice that specifies in reasonable detail the basis of the claim for
indemnification hereunder ("Notice of Indemnity Claim"). Subject to any
applicable statute of limitation periods, the failure of the Indemnified
Party to give a Notice of Indemnity Claim shall not relieve the
Indemnifying Party of its indemnification obligations hereunder except to
the extent that such failure shall result in material prejudice to the
Indemnifying Party. The Indemnifying Party shall, at its sole expense and
liability, assume the defense of any Third Party Claim within ten (10)
business days after receipt of a Notice of Indemnity Claim with respect
thereto. Should the Indemnifying Party, within ten (10) business days
after receipt of the Notice of Indemnity Claim, fail to (i) notify the
Indemnified Party in writing of the Indemnifying Party's intention to
assume the defense thereof, or (ii) retain legal counsel reasonably
satisfactory to the Indemnified Party to conduct the defense of such
Third Party Claim, then the Indemnified Party shall be entitled, at the
sole expense and liability of the Indemnifying Party, to exercise full
control of the defense, compromise or settlement of such Third Party
Claim.
Provided that the Indemnifying Party assumes the defense of any Third
Party Claim, the Indemnifying Party shall have the right to exercise full
control of the defense, compromise or settlement of such Third Party
Claim. The Indemnified Party shall have the right to engage separate
legal counsel and to participate in the defense, compromise or settlement
thereof; provided, however, that the expenses of such legal counsel shall
be paid by the Indemnified Party unless (i) the Indemnifying Party has
agreed in writing to pay such expenses, (ii) any relief other than the
payment of money damages is sought against the Indemnified Party or (iii)
the Indemnified Party shall have one or more legal defenses available to
it which are in conflict with those available to the Indemnifying Party,
in any of which cases identified in clause (i), (ii) or (iii), the
expenses of such separate legal counsel shall be borne by the
Indemnifying Party. The Party not assuming the defense of any Third Party
Claim shall cooperate with the Party assuming such defense in any manner
that the Party assuming such defense reasonably may request, except to
the extent such cooperation may result in liability or damages to the
cooperating Party not indemnified against by the other Party hereunder.
The Indemnified Party shall not settle or compromise any Third Party
Claim for which it is entitled to indemnification hereunder without the
prior written consent of the Indemnifying Party unless the Indemnifying
Party shall have failed to undertake the defense and control of such
Third Party Claim in the manner hereinabove required. For any Third Party
Claim in which the relief sought is other than monetary damages, the
Indemnifying Party shall not settle
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or compromise the non-damage component of such Third Party Claim unless
the Indemnified Party consents in writing to such compromise or
settlement.
The respective rights and remedies of the Parties in this Section 14.4
shall survive the expiration or termination of this Agreement until
ninety (90) days following the expiration of the statute of limitations
applicable to the Third Party Claim for which indemnification may be
sought hereunder; provided, that if a Notice of Claim respecting a Third
Party Claim has been timely given, the limitations period shall be
extended until the final, binding and nonappealable resolution of such
Third Party Claim and the Indemnified Party's right to indemnification
hereunder, but for only so long as the Indemnified Party continues to
pursue its indemnification rights with reasonable diligence under the
circumstances.
13.10 PROCEDURE FOR HANDLING DIRECT CLAIMS PRIOR TO ARBITRATION. In the event
that Subcontractor or ALERE makes a Claim against the other Party under
or by virtue of this Agreement which is not a Third Party Claim (a
"Direct Claim"), the Party making the claim (the "Aggrieved Party") shall
deliver to the Party from whom recovery or reimbursement of the Claim is
sought (the "Responsible Party") a notice specifying in reasonable detail
the basis of the Claim for which recovery or reimbursement is sought,
together with the estimated amount of such Claim, as determined by the
Aggrieved Party (a "Notice of Direct Claim"). Without limiting either
Party's termination rights under this Agreement, neither Party may
institute arbitration or, when permitted, litigation under this Agreement
with respect to a Direct Claim unless the Aggrieved Party has furnished
the Responsible Party with the Notice of Direct Claim and the Direct
Claim remains unpaid or unresolved to the mutual satisfaction of the
Parties for at least forty-five (45) days following receipt of the Notice
of Direct Claim. Subject to any applicable limitations periods, the
failure of the Aggrieved Party to give a Notice of Direct Claim shall not
relieve the Responsible Party of its obligations under this Agreement
except to the extent that such failure shall result in material prejudice
to the Responsible Party. The rights of the Parties to make a Direct
Claim shall survive the termination of this Agreement until the
expiration of the statute of limitations applicable to such Direct Claim;
provided, that if a Notice of Direct Claim has been timely given prior to
the expiration of the limitations period, the limitations period shall be
extended until the final, binding, and nonappealable resolution of such
Claim and the Aggrieved Party's right to recovery, but only for so long
as the Aggrieved Party continues to pursue its rights with reasonable
diligence under the circumstances. Notwithstanding the foregoing
provisions of this Section 14.5 or any other provisions of this
Agreement, either Party shall have the right to seek immediate injunctive
or other equitable relief in a court of competent jurisdiction without
notice (except as required by applicable Laws and Regulations) or delay.
14 LIABILITY AND REMEDIES.
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14.1 EQUITABLE RELIEF. Each Party acknowledges and agrees (i) that it would be
difficult or impossible to measure the damage to the other Party or such
other Party's Related Parties from any breach of a Party's obligations
under Sections 11 or 12 of this DMSA, (ii) that injury to the other Party
or such other Party's Related Parties arising from any such breach would
be impossible to calculate, and (iii) that money damages therefor would
be an inadequate remedy for any such breach. Therefore, each Party
acknowledges and agrees that either Party, in addition to any of their
other rights or remedies, shall be entitled to seek injunctive and other
equitable relief without bond or other security in the event of an actual
or threatened breach of the provisions of Sections 11 or 12 of this DMSA
by the other Party. The obligations of each Party and the rights and
remedies of each Party under Sections 11 and 12 of this DMSA are
cumulative and in addition to, and not in lieu of, any obligations,
rights or remedies created by laws protecting or enforcing Intellectual
Property Rights, including the statutory and common laws governing unfair
competition or misappropriation or theft of trade secrets, proprietary
rights or confidential information.
14.2 SUSPECTED INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS. In the event that
Tuft's or ALERE's use of any Services or Deliverables is reasonably
likely to become, or becomes, the subject of a Claim of infringement of
the Intellectual Property Rights of one or more Third Parties, then, in
addition to any other license fees, penalties or other Losses, Expenses
or Judgments against which ALERE or any Alere Indemnitees is indemnified
pursuant to Section 14 above, Subcontractor shall, at its option and
expense, either (i) procure for the effected person the right to continue
using such Services or Deliverables with the infringing component(s)
thereof, or (ii) modify the Services or Deliverables or substitute
components or parts therein so that they will no longer infringe or
violate the Intellectual Property Rights of Third Parties; provided,
however, that no such modification or substitution shall relieve
Subcontractor from its obligations to perform in accordance with the
Service Level Standards, Performance Targets and all other requirements
of this Agreement and all applicable SOWs.
14.3 BREACH BY PERSONNEL OR CONTRACTOR. Each Party shall indemnify, defend and
hold harmless the other Party, its Affiliates and Related Parties
against, and be responsible, financially and otherwise for, any breach or
violation of any provision of this Agreement made by any personnel or
Contractor of ALERE or Subcontractor, including, but not limited to, the
provisions of Sections 11 and 12 hereof. In addition to all other
remedies specified in this Agreement or available at law or in equity,
ALERE and Subcontractor shall be entitled to seek damages or other
appropriate remedies against the other Party in all cases where the
conduct or omission of any of Party's personnel or Contractor breaches or
violates, or threatens to breach or violate, the terms of any SOW or this
Agreement.
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14.4 CONSEQUENTIAL AND SPECIAL DAMAGES. Neither Party shall be liable to the
other Party for any incidental, consequential, special, punitive or other
indirect damages, including, but not limited to, damages for economic
loss, lost profits, loss of reputation or lost opportunities, even if the
Party had been advised of the possibility of any such loss and/or such
damages resulting from the breach, except in the case of Losses,
Judgments or Expenses arising or resulting from, or attributable to, any
of the following circumstances: (i) any breach or violation of the
Parties' respective obligations under Section 11 (Protection of
Information; Nonsolicitation) or Section 12 (Intellectual Property
Rights) of this DMSA; (ii) any violation by Subcontractor or its
personnel or Contractors of Laws and Regulations applicable to the
Services; (iii) personal injury, death or damage to tangible property;
(iv) the Parties' respective indemnification obligations for Third Party
Claims under Section 14 (Indemnification and Reimbursement Rights of the
Parties) of this DMSA; or (v) the gross negligence, willful misconduct or
fraud of either Party.
14.5 SURVIVAL. The following provisions of this DMSA shall survive the
expiration or earlier termination of any SOW or this DMSA for any reason
whatsoever: (i) representations, warranties and covenants furnished by
Alere and Subcontractor in Section 8 of this DMSA; (ii) the Parties'
respective obligations under Sections 11, 12, 13.4, 14, 15 and 16 of this
DMSA; (iii) the remedies to which either Party may be entitled under
Sections 7, 8, 11, 14, 15 and 16 of this DMSA; (iv) or any other
provision of this Agreement (including any SOW) which expressly survives
such termination; and (v) any other provisions of this DMSA (including
any SOW) that is necessary to interpret or enforce any of the foregoing
provisions.
15 INSURANCE. Except as otherwise noted, Subcontractor shall at all times
during the Term carry and maintain in full force and effect the following
insurance, at its sole cost and expense, to insure against risks or
liability for which Subcontractor is responsible during the Initial Term
and any Renewal Term and for such additional period of time as may be
required to complete the Services to be performed or furnished under any
SOW:
15.1 COMMERCIAL GENERAL LIABILITY INSURANCE. Subcontractor shall maintain
commercial general liability insurance, including premises liability,
products liability (if products are being provided), completed operations
coverage (if services are being provided), and contractual liability
insurance, with limits of not less than One Million Dollars ($1,000,000)
per occurrence and Two Million Dollars ($2,000,000) annual aggregate, for
bodily injury (including death) and property damage, covering all of
Subcontractor's operations in connection with this DMSA. Said insurance
shall be on an "occurrence" form.
15.2 WORKERS' COMPENSATION AND EMPLOYER'S LIABILITY. Subcontractor shall
maintain workers' compensation and employer's liability coverage with
minimum limits as follows:
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15.2.1 WORKERS COMPENSATION:Statutory limits as required by law
15.2.2 EMPLOYERS LIABILITY:
Bodily Injury by accident: $1,000,000 each accident
Bodily Injury by disease: $1,000,000 each employee
Bodily Injury by disease: $1,000,000 policy limit
15.3 PROFESSIONAL (ERRORS AND OMISSIONS) LIABILITY. Subcontractor shall
maintain professional liability coverage with minimum limits of Five
Million Dollars ($5,000,000) per occurrence and Five Million Dollars
($5,000,000) annual aggregate. Each of such insurance coverages shall be
maintained for a period of not less than three (3) years after the
expiration or termination of this DMSA. In addition, Subcontractor shall
maintain Internet errors and omission insurance liability coverage with
minimum LIMITS OF FIVE MILLION DOLLARS ($5,000,000) PER OCCURRENCE AND
FIVE Million Dollars ($5,000,000) annual aggregate.
If, in any of the foregoing cases, if Subcontractor has procured a
claims-made based policy (or policies) and such policy (or policies) are
cancelled or not renewed, Subcontractor agrees to exercise any option
contained in said policy (or policies) to extend the reporting period to
the maximum period permitted; provided, however, that Subcontractor need
not exercise such option if the superseding insurer will accept all prior
claims.
15.4 TYPES OF INSURANCE CARRIERS. Each of Subcontractor's insurance policies
shall: (i) be issued by companies that have an A. M. Best rating of not
less than "A-", and are in a size category which is not lower than
"VIII"; (ii) be primary and noncontributory with any of the ALERE's
insurance; (iii) name ALERE as an additional insured (except workers'
compensation and employer's liability); and (iv) provide ALERE with
written notice of cancellation, non-renewal or material change in the
form or limits of coverage. Subcontractor shall cause its insurance
carriers, brokers or agents to issue to ALERE certificates of insurance
evidencing all insurance coverages required by this Section 16.
Notwithstanding any other provision of this DMSA, failure to provide the
coverages provided for herein, or the certificates of insurance, shall be
grounds for immediate termination of this DMSA upon receipt written
notice thereof.
15.5 NO LIMITATION ON LIABILITY. None of the foregoing requirements as to the
type and limits of insurance to be maintained by Subcontractor are
intended to and shall not in any manner limit or qualify the liabilities
and obligations for which Subcontractor is responsible under any SOW, any
other provision of this DMSA or by law.
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15.6 SURVIVAl. The obligations under this Section 16 shall survive the
termination of this DMSA or any SOW.
16 FORCE MAJEURE. Neither Party shall be liable to the other for any breach
of a SOW or other provision of this Agreement resulting from any failure
to perform if such performance is delayed, impaired or prevented by any
event of force majeure such as fire or explosion, act of terror, flood,
earthquake, severe weather or other act of God, strike, lockout, boycott,
picketing, labor dispute or disturbance, order or act of any Governmental
Authority, or any cause beyond the reasonable control of the
non-performing Party (the "Affected Party"), including, but not limited
to, failures, fluctuations or interruptions in electrical power, heat,
light, telecommunication lines or telephones (any such cause, a "Force
Majeure Event"); provided that such non-performance (i) was not caused by
the fault or negligence of the Affected Party, (ii) could not have been
prevented by reasonable precautions taken by the Affected Party and (iii)
cannot reasonably be circumvented by the Affected Party through the use
of alternate resources, work-around plans or other means; and provided,
further, that the occurrence of a Force Majeure Event in respect of
another customer of Subcontractor shall not, by itself, constitute a
Force Majeure Event with respect to ALERE. Upon the occurrence of a Force
Majeure Event, the Affected Party shall immediately notify the other
Party of the occurrence thereof, and describe in reasonable detail the
nature and effect on the Affected Party's operations of the Force Majeure
Event. The Affected Party shall be excused from the performance of those
obligations under this Agreement that are adversely affected by the Force
Majeure Event for as long as (a) such Force Majeure Event continues, and
(b) such Affected Party continues to use best efforts to resume
performance of the Services whenever and to whatever extent possible. If
any Force Majeure Event delays, impairs or prevents Subcontractor's
performance or arrangement of the Services for more than seventy-two (72)
hours, ALERE may immediately terminate this DMSA or any affected SOW,
without, in either case, providing any opportunity to cure pursuant to
Section 13.2.1 or otherwise, by giving written notice of such termination
to Subcontractor.
17 NOTICES. Any and all notices, requests, consents, demands or other
communications required or permitted to be given under this Agreement
shall be in writing and shall be deemed to have been duly given (i) when
delivered, if sent by United States registered or certified mail (return
receipt requested), (ii) when delivered, if delivered personally by
commercial courier, (iii) on the second following business day, if sent
by United States Express Mail, Federal Express or other commercial
overnight courier or (iv) upon the date reflected on a facsimile
confirmation from the transmitting facsimile machine, if sent by
facsimile transmission and delivery of the facsimile transmission is
subsequently confirmed telephonically within one (1) business day, in
each case to the Parties at the following addresses or facsimile numbers
(or at such other addresses or facsimile numbers as shall be specified by
like notice) with applicable postage or delivery charges prepaid:
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If to Subcontractor:
Enhanced Care Initiatives, Inc.
Six Xxxxxxxxx Xxxxx
Xxxxx 000
Xxxxxxx, XX 00000
Facsimile No. 000-000-0000
Attn: Xxxxx Chess, MD
Chief Executive Officer
If to ALERE:
ALERE Medical Incorporated
000 Xxxxxx Xxxxx Xxxxx, Xxxxx 0000
Xxxx, XX 00000
Facsimile No.:000-000-0000
Attention: Xxx Xxxxxx, M.D.
Chief Executive Officer
18 ASSIGNMENT. Except as provided otherwise herein, neither party shall
assign its rights or, except as permitted by this Agreement, delegate its
duties under any SOW or this DMSA, without the prior written consent of
the other party, which consent shall not be unreasonably withheld,
conditioned or delayed, and any attempt to do so shall be void and of no
force or effect for any purpose whatsoever and shall constitute a
material breach of this DMSA that shall allow the aggrieved Party to
immediately terminate this DMSA. Not withstanding a party's consent to
any assignment or delegation by the other party, the assigning Party
shall remain primarily liable for the performance of the assignee or
delegate of the assigning Party's obligations under this Agreement,
unless otherwise agreed by the other party in writing. Subject to the
forgoing limitations, this Agreement shall be binding upon the Parties
hereto and to the permitted successors, successors-in-interest and
assigns of the Parties.
19 GOVERNING LAW; JURISDICTION. This Agreement shall be construed and
enforced in accordance with the laws of the State of Nevada without
regard to its conflicts of laws provisions and, when applicable, the
Parties' obligations under this Agreement shall be governed by the laws
of the United States and any other state's Laws and Regulations that must
be applied. Any legal action, suit or proceeding arising out of or
relating to this Agreement may be instituted in any state or Federal
court located within the County of Washoe, State of Nevada, and each
Party agrees not to assert, by way of motion, as a defense, or otherwise,
in any such action, suit or proceeding, any claim that such Party is not
subject personally to the jurisdiction of such court in an inconvenient
forum, that the venue of the action, suit or proceeding is improper or
that this DMSA or the subject matter hereof may not be enforced in or by
such court. Each Party further irrevocably submits to the jurisdiction
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of any such court in any such action, suit or proceeding. Any and all
service of process shall be effective against a Party if given personally
or by registered or certified mail, return receipt requested, or by any
other means of mail that requires a signed receipt, postage prepaid,
mailed to such Party as herein provided. Nothing herein contained shall
be deemed to affect the right of any Party to serve process in any manner
permitted by law or to commence legal proceedings or otherwise proceed
against any other Party in any other jurisdiction.
20 BINDING ARBITRATION. Any claim, controversy dispute or disagreement of
whatsoever nature between the Parties hereto or involving this Agreement,
including the disposition of a Direct Claim, shall, except as expressly
provided below or elsewhere in this Agreement, be resolved by binding
arbitration by a single arbitrator in accordance with the American
Arbitration Association ("AAA"), and administration of the arbitration
shall be performed by AAA or such other arbitration service as the
Parties may agree in writing. The Parties will endeavor to mutually agree
to the appointment of the arbitrator, but if such agreement cannot be
reached within thirty (30) days following the date demand for arbitration
is made, the arbitrator appointment procedures in the AAA Rules will be
utilized. Arbitration hearings shall be held in Washoe County, Nevada or
at such other location as the parties may agree in writing. Civil
discovery may be taken in such arbitration as provided by federal law and
civil procedure. The arbitrator selected shall have the power to control
the timing, scope and manner of the taking of discovery and shall further
have the same powers to enforce the parties' respective duties concerning
discovery as would a federal district court including, but not limited
to, the imposition of sanctions. The arbitrator shall have the power to
grant all remedies provided by Nevada law. The Parties shall divide
equally the expenses of AAA and the arbitrator; provided, however, that
the arbitrator shall have the power to assess all such costs and expenses
to the non-prevailing Party in the arbitrator's award. The arbitrator
shall prepare in writing an award that includes the legal and factual
reasons for the decision. The arbitrator shall not have the power to
commit errors of law or legal reasoning and the award may be vacated or
corrected pursuant to Nevada law. The arbitrator shall be bound by and
required to apply to the disputed matters subject to arbitration the
internal laws of the State of Nevada, without regard to principles of
conflicts of law, and by federal law where Nevada law is preempted. The
Federal Arbitration Act, 9 U.S.C. xx.xx. 1-16, shall apply to the
arbitration. Each Party knowingly acknowledges and agrees that the
foregoing constitutes a waiver of its right to a jury trial. The entire
arbitration procedure shall be confidential and neither any party to the
arbitration nor the arbitrator may disclose the content or results of any
arbitration hereunder without the written consent of the other parties,
except to the extent disclosure is required to enforce any applicable
arbitration award or as may be otherwise required by law or upon the
request of a Governmental Authority and except that any party may make
such disclosures to its auditors, accountants, attorneys, insurers,
actual and prospective investors, and actual and potential
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lenders. Notwithstanding anything to the contrary in this Section or
elsewhere in this Agreement: (i) if a Governmental Authority with
jurisdiction over either Party determines that a Party is not in
compliance with applicable Laws and Regulations pertinent to this
Agreement, then such finding or determination need not be subject to
arbitration; and (b) a Party shall be permitted to seek a temporary
restraining order, preliminary injunction, order to compel arbitration or
in support of arbitration or other provisional remedies from a court of
competent jurisdiction, including, but not limited to, seeking such
remedies in connection with any claim, controversy, dispute or
disagreement contemplated by Section.
21 INDEPENDENT CONTRACTORS. The Parties and their respective personnel are
and shall continue to be independent contractors with respect to each
other. Subcontractor and its personnel and Contractors shall not, by
virtue of any SOW or any provision of this Agreement become, and under no
circumstances shall any of them be construed as being, an employee,
agent, joint venturer, partner or Affiliate of ALERE or standing in any
relationship with respect to ALERE that would impose liability on ALERE
for the actions or omissions of Subcontractor, its personnel or its
Contractors. Without limiting the generality of the foregoing, nothing in
this Agreement, including in any SOW, shall be construed as establishing
the relationship of employer and employee between ALERE and
Subcontractor, its employees or Contractors for any purposes, including
state or Federal tax purposes. Subcontractor and its employees and
Contractors are not entitled to any mandatory or fringe employee benefits
from ALERE, including, without limitation, workers' compensation,
unemployment compensation, health or disability insurance or vacation or
sick pay.
22 ENTIRE AGREEMENT. This Agreement shall constitute the final written
integrated expression of all of the understandings and agreements between
Subcontractor and ALERE with respect to the performance of any Services
and delivery of any Deliverables contemplated under this Agreement and
the other subjects addressed in this DMSA and any SOW entered into by
Subcontractor and ALERE. This Agreement supersedes all prior or
contemporaneous, written or oral, memoranda, arrangements, contracts or
understandings between the Parties relating to the subjects addressed
therein. Any representations, promises warranties or statements made by
any Party which differ in any way from the terms of this Agreement shall
be given no force or effect.
23 AMENDMENTS; WAIVERS. Except as otherwise expressly provided in this
Agreement, changes or modifications to this Agreement or to any SOW may
not be made orally, but only by a dated, written instrument executed by
Subcontractor and ALERE; provided, however, that Subcontractor agrees
that ALERE shall be permitted to amend this Agreement or any SOW
effective upon thirty (30) days written notice to Subcontractor if the
substance of such amendment is required by any Laws or Regulations
applicable to ALERE or
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Tufts or any directives from a Governmental Authority or Accreditation
Organization regulatory or certifying a ALERE, Tufts, or its Health Plans
or other operations. Any terms or conditions varying from this Agreement
or any SOW on any order, invoice or other notification from either Party
shall not be binding upon the Parties unless specifically accepted in
writing by the Party against whom enforcement is sought. Unless otherwise
expressly provided in this Agreement, including in any SOW, a delay or
omission by either Party to exercise any right or power under this
Agreement shall not be construed to be a waiver thereof. No waiver of any
breach of any provision of any SOW or this Agreement shall be effective
unless evidenced by a dated written instrument executed by the Party
against whom enforcement of such waiver is sought. No waiver of any
breach of any provision of any SOW or this Agreement will constitute a
waiver of any prior, concurrent or subsequent breach of the same or any
other provision hereof or thereof.
24 SEVERABILITY. In the event that any provision in this Agreement shall be
found by a Governmental Authority, court or arbitrator of competent
jurisdiction to be invalid, illegal or unenforceable, such provision
shall be construed and enforced as if it had been narrowly drawn so as
not to be invalid, illegal or unenforceable, and the validity, legality
and enforceability of the remaining provisions of this DMSA shall not in
any way be affected or impaired thereby. In the event, however, that the
remaining unaffected provisions of this Agreement are inadequate to
permit each Party to realize the material benefits for which such Party
has bargained hereunder, then, before this Agreement may be terminated as
provided herein, the Parties shall, in good faith, attempt to negotiate
mutually acceptable substitute provisions (which negotiations need not
exceed thirty (30) calendar days) that are valid, legal and enforceable
and that most nearly provide for the realization of the material benefits
sought to be accomplished by the provision or provisions held to have
been illegal, invalid or unenforceable.
25 CONSTRUCTION OF AGREEMENT. The Parties agree that:
25.1 JOINT PARTICIPATION. This DMSA has been drafted with the joint
participation of each of the Parties hereto and shall be construed to be
neither against nor in favor of either Party, but rather in accordance
with the fair meaning hereof.
25.2 NO THIRD PARTY BENEFICIARIES. This Agreement does not create, and shall
not be construed as creating, any rights enforceable by any Person who is
not a Party to this Agreement.
25.3 USE OF DEFINED TERMS. Any defined term used in this Agreement in the
plural shall refer to all members of the relevant class and any defined
term used in the singular shall refer to any one or more of the members
of the relevant class.
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25.4 DAY OR DAYS. Use of the terms "day" or "days" in this DMSA shall mean and
refer to calendar days unless either term is expressly modified by a
reference to "business" day(s).
25.5 ARTICLES, SECTIONS, EXHIBITS AND SCHEDULES. References in this DMSA to
articles, sections, exhibits and schedules are to articles, sections,
exhibits and schedules of and to this DMSA. All exhibits and schedules to
this DMSA, either as originally existing or as the same from time to time
may be supplemented, modified or amended, are hereby incorporated in full
into this DMSA by this reference.
26 COUNTERPARTS. This DMSA, the SOWs or any other instrument to be entered
into by the Parties in connection with this DMSA may be executed in any
number of counterparts, all of which taken together shall constitute one
single agreement between the Parties.
IN WITNESS WHEREOF, each Party has caused this DMSA to be signed by its
duly authorized representative on _________________, 2006 to be effective
as of the Effective Date.
ALERE MEDICAL
INCORPORATED SUBCONTRACTOR
By: /s/_______________________ By: /s/ ____________________
Title: Title:
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EXHIBIT A
SCHEDULE OF DEFINITIONS
"Accreditation Organization" means any organization, including, without
limitation, the National Committee for Quality Assurance (NCQA), engaged in
accrediting or certifying Tufts, the Medicare Health Plans and/or Tuft's
providers of health care services, products or devices, including
Subcontractor.
"Affiliate," with respect to any Person, means another Person that directly
or indirectly controls, is controlled by or is under common control with
that Person. For purposes of this definition, the term `control' (including
the terms `controlling', `controlled by' and `under common control with')
of a Person means possession of the power, directly or indirectly, to
direct or cause the direction of the management and policies of such
Person, whether through the ownership of voting securities, membership
interests, by contract, or otherwise.
"Aggrieved Party" has the meaning ascribed to it in Section 14.5.
"Agreement" shall mean the foregoing provisions of this DMSA, together with
all Exhibits, Schedules, SOWs or other attachments attached to or
incorporated by reference into the DMSA, and all exhibits, schedules and
attachments to such SOWs, and any amendment, modification, revision,
supplement or deletions to any of the foregoing made in accordance with the
requirements of the this Agreement and any applicable SOW.
"ALERE" means ALERE Medical Incorporated, a California corporation.
"ALERE Content" means any text, graphics, photographs, video, audio and/or
other data or information, including any advertisements, which display any
of the ALERE Marks (and none of the Subcontractor Marks) or which is used
by ALERE or any Related Party of ALERE, including, without limitation, any
marketing, promotional or descriptive materials of ALERE's products,
devices or services. The content of any ALERE Developed Materials also
shall constitute ALERE Content.
"ALERE Data" means and includes (i) all data, records, reports and
information generated, created or developed by ALERE or its contractors
(other than Subcontractor) in the performance or arrangement of disease
management services for clients other than Tufts; (ii) all data, records
and information generated from ALERE's respective businesses and operations
other than the performance of this Agreement, including, without
limitation, contact, personal and other information pertaining to ALERE's
past, present
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or prospective customers, employees and representatives, (iii) all
information pertaining to the programs, services or products marketed or
offered by ALERE in general, including, without limitation, information
pertaining to staffing, policies and procedures, internal methods and
systems operational protocols of ALERE, and information pertaining to
amounts paid to ALERE by its customers, (iv) any documentation describing,
evidencing, marketing or promoting the products, services or programs of
ALERE generally, (v) any trade secrets or secret business processes or
methods of ALERE, (vi) ALERE's software and any tangible or readable
embodiments of such software, (vii) any toll free inbound telephone numbers
used or established to provide Services under this DMSA or other telephone
numbers controlled by ALERE, and (viii) in the case of any of the matters
referenced in any of the foregoing clauses (i) through (vii), data, records
or information occurring in any form whatsoever, including, but not limited
to, written, graphic, electronic, visual or fixed in any tangible medium of
expression.
"ALERE Developed Materials" mean and include any Development which is made,
created, authored, conceived or developed by ALERE, alone or jointly with
others for or in connection with ALERE's business, services or operations.
"ALERE Indemnitees" has the meaning ascribed to it in Section 14.3.
"ALERE Marks" means any service marks, trademarks, trade names, domain
names, URLs, logos, icons, slogans, words or phrases and advertising
(including text, graphic or audiovisual features of icons, banners or
frames) which bear the name or identification of ALERE or of any Related
Party of ALERE.
"ALERE Systems" means any computer, software, hardware, telecommunications,
telephone, voice or data systems utilized by ALERE or one of its
Contractors in the performance of the Services, exclusive of the Tufts
Systems.
"Annual Plan" has the meaning ascribed to it in Section 5.2.
"Authorizations" has the meaning ascribed to it in Section 8.2.
"Authorized Contractor" means any vendor engaged by the Subcontractor whose
subcontract with Subcontractor satisfies all applicable obligations of this
DMSA.
"Bankruptcy Code" means Title 11 of the United States Code.
"Bankruptcy Event" with respect to a Person means: (i) a proceeding or case
has been commenced against a Person, without the application or consent of
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such Person, in any court of competent jurisdiction, seeking (a) such
Person's liquidation, reorganization, dissolution or winding-up, or the
composition or readjustment of its debts, (b) a petition commencing a case
under the Bankruptcy Code (as now or hereafter in effect), (c) the
appointment of a trustee, receiver, custodian, liquidator or the like of
such Person or of all or any substantial part of any of its assets or (d)
similar relief in respect of the bankruptcy, insolvency, reorganization,
winding-up or composition or adjustment of debts, and such proceeding or
case shall continue undismissed, or an order, Judgment, or decree approving
or ordering any of the foregoing; (ii) an order for relief against a Person
shall be entered in an involuntary case under the Bankruptcy Code; (iii) a
Person shall (a) apply for or consent to the appointment of, or the taking
of possession by, a receiver, custodian, trustee or liquidator of itself or
of all or a substantial part of its property, (b) make a general assignment
for the benefit of its creditors, (c) commence a voluntary case under the
Bankruptcy Code (as now or hereafter in effect), (d) file a petition
seeking to take advantage of any other law relating to bankruptcy,
insolvency, reorganization, winding-up or composition or readjustment of
debts, (e) fail to controvert in a timely and appropriate manner, or
acquiesce in writing to, any petition filed against it in an involuntary
case under the Bankruptcy Code (as now or hereafter in effect); or (f) a
Person taking any corporate, partnership or other entity action for the
purpose of effecting any of the foregoing.
"Business Associate Agreement" means the Business Associate Addendum
entered into between Subcontractor and ALERE, which is attached to this
DMSA as EXHIBIT C and any subsequent versions of the Business Associate
Addendum as ALERE shall adopt for use.
"Business Cessation Event" with respect to either a Person means that (i)
such Person dissolves its corporate, partnership or other entity structure,
winds up its business affairs or ceases to do business for any other
reason, except pursuant to a (i) sale and acquisition of all or
substantially all of such Person's business or assets, or (ii)
reorganization, merger or similar transaction in which its business is
continued by another Person that is competent to carry on such business, or
(ii) such Person has taken any official corporate, partnership or other
entity action for the purpose of effecting any of the foregoing.
"Change of Control" with respect to Subcontractor means either (i) a sale
or disposition of all or substantially all of the assets of the
Subcontractor, (ii) a sale of 50% or more of the voting capital stock of
the Subcontractor, or (iii) any transaction (or series of related
transactions involving a person or entity, or a group of affiliated persons
or entities) in which excess of 50% of the Subcontractor's outstanding
voting power is transferred.
"Change Order Proposal" has the meaning ascribed to it in Section 10.
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"Claim" means any claim, legal or equitable cause of action, suit,
litigation, proceeding (including a regulatory or administrative
proceeding), grievance, complaint, demand, charge, investigation, audit,
arbitration (or demand therefore), mediation or other process for settling
disputes or disagreements, including, without limitation, any of the
foregoing processes or procedures in which injunctive or equitable relief
is sought.
"CMS" means the United States Centers for Medicare and Medicaid Services,
formerly known as the Health Care Financing Administration ("HCFA").
"Commercial Plan" means a commercial prepaid Health Plan.
"Compensation Records" has the meaning ascribed to it in Section 2.10.
"Confidential Information" has the meaning ascribed to it in Section 11.2.
"Contractor" means any individual or other Person who or which performs, on
behalf of Subcontractor or ALERE, any Services contemplated by this DMSA
(including a leased employee) other than an individual who is an employee.
"Default(ing)" has the meaning ascribed to it in Section 13.2.1.
"Deliverables" mean and include (i) any tangible materials, products or
reports to be furnished or delivered by Subcontractor to ALERE or any other
Person as a result of or as an embodiment of any of the Services to be
furnished pursuant to this Agreement or any SOW, and (ii) any severable
part of any of the items referenced in the foregoing clause (i).
"Developments" means and includes all developments, inventions, concepts,
plans, techniques, designs, models, literary works, works of authorship
(including, but not limited to, training materials, curricula scripts,
reports and computer screens), processes, methodologies, discoveries,
formulae, contributions, findings or improvements, technology, computer
software applications, programs, interfaces, systems and databases
(including with respect to any of the foregoing any source codes or object
codes relating thereto) and voice or data recordings which are made,
created, authored, conceived, developed, prepared, irrespective of whether
new, useful, patentable or protectable under statutory or common law.
"Disclosing Party" has the meaning in Section 11.1.
"Disease Management Services" has the meaning in Section 1.1.1.
"Effective Date" means _________________.
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"Expenses" mean any and all costs, expenses and fees, including costs of
settlement, attorneys' fees, accounting fees, expert costs and fees and
witness fees incurred in connection with Claims which are the subject of
indemnification or reimbursement under this DMSA or Losses or Judgments
arising from such Claims.
"Force Majeure Event" has the meaning ascribed to it in Section 17.
"GLB" means the U.S. Xxxxx-Xxxxx-Xxxxxx Act and the rules and regulations
from time to time promulgated thereunder.
"Governmental Authority" means the Federal government, any state, county,
municipal, local or foreign government or any governmental department,
political subdivision, agency, bureau, commission, authority, body or
instrumentality or court, including, but not limited to, CMS and any
department, division, agency or insurance commissioner that regulates the
activities or operations of the Parties, Tufts or the Medicare Health
Plans.
"HCFA Internet Security Policy" means the HCFA Internet Security Policy
issued by CMS (then the Health Care Financing Administration) on November
24, 1998, as the same from time to time may be amended, replaced or
codified.
"Health Plan(s)" mean and include one or more of the Commercial or Medicare
Health Plans underwritten, offered, sold, administered, arranged or managed
by a Tufts Affiliate.
"HIPAA" means the Health Insurance Portability and Accountability Act of
1996, as may be amended, modified, revised or replaced or interpreted by
any Governmental Authority or court.
"HIPAA Regulations" means the rules and regulations adopted by the U.S.
Department of Health and Human Services pursuant to HIPAA, including
without limitation (i) the Standards for Privacy of Individually
Identifiable Health Information set forth at 45 C.F.R. Parts 160 and 164
(subparts A and E), (ii) the Security Standards for the Protection of
Electronic Protected Health Information, 45 C.F.R. parts 160 and 164
(subparts A and C), (iii) the Standards for Electronic Transactions and
Code Sets, 45 C.F.R. parts 160 and 162 and (iv) any amendments,
modifications, revisions or replacements or interpretations of the
regulations identified in the foregoing clauses (i), (ii) or (iii) by any
Governmental Authority or court.
"Implementation Services" has the meaning ascribed to it in Section 2.2.2.
"Indemnified Party" has the meaning ascribed to it in Section 14.4.1.
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"Indemnifying Party" has the meaning ascribed to it in Section 14.4.1.
"Initial Term" has the meaning ascribed to it in Section 13.1.
"Intellectual Property" or "Intellectual Property Rights" means any patent,
invention, discovery, know-how, moral, technology, software, copyright,
trade secret, trademark, confidentiality, proprietary, privacy,
intellectual property or similar rights (including rights in applications,
registrations, filings and renewals thereof) which are now or hereafter
protected or legally enforceable under state or Federal common laws or
statutory laws of the United States or under laws of foreign jurisdictions.
"IT Development Work" means any software programming and any software
development, design, configuration, adaptation, integration or installation
of computer hardware, software (including, applications, programs,
interfaces, operating systems, databases and the source codes and object
codes relating to the foregoing), telecommunications or data communications
infrastructure or systems and other technology products or systems which,
in the case of any of the foregoing, is developed, created or performed by
a Party, alone or jointly with its Contractors, whether (i) as any part of
any Implementation Services or other Services to performed pursuant to a
SOW or (ii) on or for the Party's systems.
"Judgments" mean any judgments, writs, orders, injunctions or other orders
for equitable relief, awards or decrees of or by any court, judge, justice
or magistrate, including any bankruptcy court or judge, and any binding
arbitration award and any order of or by any Governmental Authority.
"Laws and Regulations" means any and all common law and any and all state,
Federal or local statutes, ordinances, codes, rules, regulations,
restrictions, orders, procedures, standards, directives, guidelines,
policies or requirements enacted, adopted, promulgated, applied, followed
or imposed by any Governmental Authority or court, including, but not
limited to, HIPAA and the HIPAA Regulations and policies, guidelines and
manuals adopted by CMS.
"Losses" mean and include any losses, damages of any kind or nature,
assessments, fines, penalties, deficiencies, interest, payments, expenses,
costs, debts, obligations, liabilities, liens or Judgments that are
sustained, incurred or accrued.
"Medicare Advantage Plan" shall mean a Medicare managed care plan
authorized by current or future Federal laws and/or administered by CMS or
any successor Governmental Authority, formerly known as Medicare+Choice
plans.
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"Medicare Health Plan(s)" mean and include one or more of the Medicare
Advantage Plans, exclusive of, for the purposes of this Agreement, a
stand-alone prescription drug only plan offered under Medicare Part D.
"Member" means an individual subscriber or dependent of such subscriber who
is enrolled in a Commercial or Medicare Health Plan offered, arranged,
administered, underwritten or provided by Tufts.
"Notice of Direct Claim" has the meaning ascribed to it in Section 14.5.
"Notice of Indemnity Claim" has the meaning ascribed to it in Section
14.4.1.
"Operational and System Readiness" with respect to the provision of
Services under any SOW means that Subcontractor, at a minimum (i) possesses
IT, voice and data systems and operational processes and protocols that are
adequate, appropriate and necessary to perform the Services in an orderly,
efficient and professional manner and otherwise in accordance with this
DMSA and such SOW; (ii) has developed the necessary software interfaces or
procedures to communicate securely with the ALERE Systems and Tufts Systems
and to support the exchange of data (including Tufts Data) between Tufts,
ALERE and Subcontractor in accordance with HIPAA and the HIPAA Regulations,
the HCFA Internet Security Policy, other applicable Laws and Regulations
and any other applicable provisions of this DMSA; and (iii) has completed
training of adequate and appropriate professional personnel to provide all
Services contemplated by such SOW in accordance with the requirements of
this DMSA.
"Tufts" means Tufts Health Plan and its subsidiaries, parents and other
Affiliates.
"Tufts Affiliate" means any current or future Affiliate of Tufts.
"Tufts Data" means and includes (i) all data and information submitted or
transmitted to Subcontractor by Tufts, Members, intermediaries or other
Third Parties in respect of Members (including, without limitation,
patient-identifiable information, other medical data and PHI), (ii) all
data, records, reports and information generated, created or developed by
Subcontractor or its contractors in course of performing the Services,
(iii) all data, records and information generated from Tuft's respective
businesses and operations, including, without limitation, contact, personal
and other information pertaining to Tuft's past, present or prospective
Members, customers, providers, employees and representatives, (iv) all
information pertaining to the Health Plans or any other health care or
consumer programs, services or products marketed, offered or underwritten
by Tufts, including, without limitation, information pertaining to
staffing, policies and procedures, internal methods and systems,
operational protocols, benefit plan or program designs,
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reimbursement amounts paid to Tufts by or on behalf of Members, rates and
compensation paid by Tufts to providers or suppliers of health care or
consumer services, products or devices, any other historical or prospective
cost and expense data pertaining to Tufts, (v) any documentation
describing, evidencing, marketing or promoting the health plan or consumer
products, services or programs of Tufts, including, but not limited to,
subscriber materials, enrollment forms, evidences of coverage, evidences of
benefits, handbooks, identification cards and benefit materials or program
descriptions of any kind, and any other Tufts Content, (vi) any data,
information, records or documentation generated by Subcontractor or its
personnel or Contractors during the course of performing any Services or
pursuant to any SOW or this DMSA or pursuant to any other arrangement with
ALERE on behalf of Tufts, (vii) any trade secrets or secret business
processes or methods of Tufts, (viii) Tuft's software and any tangible or
readable embodiments of such software, (ix) any and all toll free inbound
telephone numbers used or established to provide Services under this DMSA
or other telephone numbers controlled by Tufts and (x) in the case of any
of the matters referenced in any of the foregoing clauses (i) through (ix),
data, records or information occurring in any form whatsoever, including,
but not limited to, written, graphic, electronic, visual or fixed in any
tangible medium of expression.
"Tufts Marks" means any service marks, trademarks, trade names, domain
names, URLs, logos, icons, slogans, words or phrases and advertising
(including text, graphic or audiovisual features of icons, banners or
frames) which bear the name or identification of Tufts, any Related Party
of Tufts other than ALERE, Subcontractor or any Medicare Health Plans,
other health plans, products, devices or services offered, sold or marketed
by Tufts or its Related Parties other than ALERE or Subcontractor,
including, but not limited to, Tufts(R), Secure Horizons(R), Secure
Horizons(R) Secure Gold and Secure Touch.
"Party" or "Parties" means one or both of Subcontractor and ALERE.
"Payment Default" has the meaning in Section 13.2.2.
"Person" means any individual, trustee, corporation, general or limited
partnership, limited liability company or partnership, joint venture, joint
stock company, bank, firm, Governmental Authority, trust, association,
organization or unincorporated entity of any kind.
"PHI" or "Protected Health Information," means, as defined at 45 C.F.R.
Section 164.501, information which (i) relates to the past, present or
future physical or mental health or condition of an individual, the
provision of health care to an individual, or the past, present of future
payment for the provision of health care to an individual, and (ii) with
respect to which there is a reasonable basis to believe the information can
be used to identify the
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individual; and will have the meaning under 45 C.F.R. Section 164.501 as
such section from time to time may be amended, modified, revised or
replaced or interpreted by any Governmental Authority or court.
"Performance Targets" means the utilization rates in medical expense
including as appropriate inpatient hospital stays, outpatient hospital
services, professional services and/or other healthcare services as set
forth in the applicable SOW to be achieved as a result of the Disease
Management Services being performed under a particular SOW, in accordance
with such SOW or an Annual Plan established with respect thereto.
"Pre-Existing Intellectual Property Right" means any software, software
systems, Inventions, discoveries, technology or other Intellectual Property
Rights owned or claimed to be owned by Subcontractor or ALERE any Third
Party or any Subcontractor or ALERE Independent Materials owned or claimed
to be owned by Subcontractor, ALERE or any Third Party.
"Privacy Laws" has the meaning ascribed to it in Section 11.3.
"Receiving Party" has the meaning in Section 11.1.
"Regulated Activities" has the meaning ascribed to it in Section 2.3.2.
"Related Party" means a customer (including a Member) strategic partner,
vendor, supplier, health care provider, service provider, investor,
Affiliate, business partner or other contractor of Subcontractor or ALERE,
as the case may be. For the purposes of this Agreement, ALERE shall not be
considered a Related Party of Subcontractor and Subcontractor shall not be
considered a Related Party of ALERE.
"Renewal Term" has the meaning ascribed to it in Section 13.1.
"Responsible Party" has the meaning ascribed to it in Section 14.5.
"Service Fees" or "Fees" means the baseline service fees or other
compensation payable to Subcontractor by ALERE under a SOW for the
provision of Disease Management Services to Tufts or its Members. On the
Effective Date, the Services Fees under applicable SOWs are typically
determined on a per Member per month (PMPM) basis, a per enrolled Member
per month basis (PEMPM) or a case rate basis
"Service Level Standards" shall mean all requirements set forth in this
Agreement and/or any SOW relating to the quality, timing, personnel,
procedures, practices, methodologies and other aspects of Subcontractor's
provision of the Services under this Agreement and/or such SOW.
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"Service Locations" has the meaning ascribed to it in Section 4.1.
"Services" means those Disease Management Services to be furnished or
arranged by Subcontractor pursuant to this Agreement and any other disease
management, staffing, resources, support, services, responsibilities, tasks
or Deliverables that are required to be furnished or performed by
Subcontractor to ALERE on behalf of, Tufts under this DMSA or one or more
SOWs issued under this DMSA.
"Statement of Work" or "SOW" has the meaning ascribed to it in Section
1.1.1.
"SOW Effective Date" shall mean the date set forth in each SOW on which
such SOW shall be effective.
"Subcontractor Account Executive" has the meaning ascribed to it in Section
2.8.
"Subcontractor Content" means any text, graphics, photographs, video, audio
and/or other data or information, including any advertisements, which
display any of the Subcontractor Marks (and none of the Subcontractor
Marks) or which is used by Subcontractor or any Related Party of
Subcontractor, including, without limitation, any marketing, promotional or
descriptive materials of Subcontractor's products, devices or services. The
content of any Subcontractor Developed Materials also shall constitute
Subcontractor Content.
"Subcontractor Data" means and includes (i) all data, records, reports and
information generated, created or developed by Subcontractor or its
contractors in the performance or arrangement of Disease Management
Services for clients other than Tufts; (ii) all data, records and
information generated from Subcontractor's respective businesses and
operations other than the performance of this Agreement, including, without
limitation, contact, personal and other information pertaining to
Subcontractor's past, present or prospective customers (other than Tufts),
employees and representatives, (iii) all information pertaining to the
programs, services or products marketed or offered by Subcontractor in
general (but exclusive of particular Disease Management Services designed
or tailored for Tufts), including, without limitation, information
pertaining to staffing, policies and procedures, internal methods and
systems operational protocols of Subcontractor that have not been developed
for Tufts or exclusively or primarily for use in connection with the
Services being furnished to Tufts, and information pertaining to amounts
paid to Subcontractor by its customers other than Tufts, , (iv) any
documentation describing, evidencing, marketing or promoting the products,
services or programs of Subcontractor generally, exclusive of any such
documentation for Disease Management Services
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designed exclusively or primarily for Tufts, (v) any trade secrets or
secret business processes or methods of Subcontractor, (vi) Subcontractor's
software and any tangible or readable embodiments of such software, (vii)
any toll free inbound telephone numbers used or established to provide
Services under this DMSA or other telephone numbers controlled by
Subcontractor, and (viii) in the case of any of the matters referenced in
any of the foregoing clauses (i) through (vii), data, records or
information occurring in any form whatsoever, including, but not limited
to, written, graphic, electronic, visual or fixed in any tangible medium of
expression. Notwithstanding the foregoing, Subcontractor Data shall not
include any Tufts Data or ALERE Data.
"Subcontractor Developed Materials" mean and include any Development which
is made, created, authored, conceived or developed by Subcontractor alone
or jointly with others for or in connection with Subcontractor's business,
services or operations.
"Subcontractor Indemnitees" has the meaning ascribed to it in Section 14.3.
"Subcontractor Marks" means any service marks, trademarks, trade names,
domain names, URLs, logos, icons, slogans, words or phrases and advertising
(including text, graphic or audiovisual features of icons, banners or
frames) which bear the name or identification of Subcontractor or of any
Related Party of Subcontractor.
"Subcontractor Systems" means any computer, software, hardware,
telecommunications, telephone, voice or data systems utilized by
Subcontractor or one of its Contractors in the performance of the Services.
"Taxes" means all sales, use, transfer, ad valorem, gross receipts, or
excise taxes and any other similar taxes, fees, duties or imposts plus any
interest and penalties imposed thereon and all expenses (including
attorney, accountant and expert fees) incurred by a Party in connection
with the payment or settlement of or defense against any claim for such
taxes.
"Term" means the Initial Term of this DMSA and/or any Renewal Term hereof.
"Third Party" means any Person other than Subcontractor or ALERE.
"Third Party Claim" has the meaning ascribed to it in Section 14.4.1.
"Transition Assistance Period" has the meaning ascribed to it in Section
13.4.
"Transition Assistance Services" has the meaning ascribed to it in Section
13.4.
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EXHIBIT B
OPM AGREEMENT
The following provisions are incorporated by reference into the Agreement.
Any capitalized terms used in this Exhibit B shall have the meaning
ascribed to such term in the Federal Employees Health Benefit Program
Standard Contract for Community-Rated Health Maintenance Organization
Carriers for contract year 2002 (the "FEHBP Contract").
1. FEHBP Contract Section 1.10:
NOTICE OF SIGNIFICANT EVENTS
(a) The Carrier agrees to notify the Contracting Officer of any Significant
Event within ten (10) working days after Carrier becomes aware of it. As
used in this section, Significant Event is any occurrence that might
reasonably be expected to have a material effect upon Carrier's ability to
meet its obligations under this contract, including, but not limited to,
any of the following:
(1) Disposal of major assets;
(2) Loss of 15% or more of Carrier's overall membership;
(3) Termination or modification of any contract or subcontract if such
termination or modification might have a material effect on Carrier's
obligations under this contract;
(4) Addition or termination of provider agreements;
(5) Any changes in underwriters, reinsurers or participating plans;
(6) The imposition of, or notice of the intent to impose, a receivership,
conservatorship, or special regulatory monitoring;
(7) The withdrawal of, or notice of intent to withdraw State licensing, HHS
qualification, or any other status under Federal or State law;
(8) Default on a loan or other financial obligation;
(9) Any actual or potential labor dispute that delays or threatens to delay
timely performance or substantially impairs the functioning of the
Carrier's facilities or facilities used by the Carrier in the performance
of the contract;
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(10) Any change in its charter, constitution, or by-laws which affects any
provision of this contract or the Carrier's participation in the Federal
Employees Health Benefits Program;
(11) Any significant changes in policies and procedures or interpretations of
the contract or brochure which would affect the benefits available under
the contract or the costs charged to the contract;
(12) Any fraud, embezzlement or misappropriation of FEHB funds; or
(13) Any written exceptions, reservations or qualifications expressed by the
independent accounting firm (which ascribes to the standards of the
American Institute of Certified Public Accountants) contracted with by the
Carrier to provide an opinion on its annual financial statements.
(b) Upon learning of a Significant Event OPM may institute action, in
proportion to the seriousness of the event, to protect the interest of
Members, including, but not limited to--
(1) Directing The Carrier to take corrective action;
(2) Suspending new enrollments under this contract;
(3) Advising Enrollees of the Significant Event and providing them an
opportunity to transfer to another plan;
(4) Withholding payment of subscription income or restricting access to The
Carrier's Letter of Credit account;
(5) Terminating the enrollment of those Enrollees who, in the judgment of OPM,
would be adversely affected by the Significant Event; or
(6) Terminating this contract pursuant to Section 1.15 of the contract between
Tufts and OPM, RENEWAL AND WITHDRAWAL OF APPROVAL.
(c) Prior to taking action as described in paragraph (b) of this clause, the
OPM will notify The Carrier and offer an opportunity to respond.
(d) The Carrier shall insert this clause in any subcontract or subcontract
modification if both the amount of the subcontract (or in the case of a
community-rated carrier, applicable to the FEHBP) exceeds $100,000 and the
amount of the subcontract or modification to be charged to the FEHBP (or in
the case of a community-rated carrier, applicable to the FEHBP) exceeds 25
percent of the total cost of the subcontract or modification. If The
Carrier is an HMO, it shall also insert this clause in all provider
agreements over $25,000. If The Carrier is not an HMO, it shall also insert
this clause in the
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contract with its underwriter, if any. The Carrier shall substitute an
appropriate reference for the term "Carrier".
2. FEHBP Contract Section 1.11
FEHB INSPECTION
(a) The Government or its agent has the right to inspect and evaluate the work
performed or being performed under the contract, and the premises where the
work is being performed, at all reasonable times and in a manner that will
not unduly delay the work. If the Government or its agent performs
inspection or evaluation on the premises of the Carrier or a subcontractor,
The Carrier shall furnish and require the subcontractor to furnish all
reasonable facilities and assistance for the same and convenient
performance of these duties.
(b) The Carrier shall insert this clause in all subcontracts for underwriting
and administrative services and shall substitute an appropriate reference
for the term "Carrier".
3. FEHBP Contract Section 1.14
MISLEADING, DECEPTIVE OR UNFAIR ADVERTISING
(a) The Carrier agrees that any advertising material, including that labeled
promotional material, marketing material, or supplemental literature, shall
be truthful and not misleading.
(b) Criteria to assess compliance with paragraph (a) of this clause are
available in the FEHB Supplemental Literature Guidelines which are
developed by OPM and should be used, along with the additional guidelines
set forth in FEHBAR 1603.702, as the primary guide in preparing material;
further guidance is provided in the NAIC ADVERTISEMENTS OF ACCIDENT AND
SICKNESS INSURANCE MODEL REGULATION. The guidelines contained in this
document are available at XXX.XXXX.XXX under "Model Laws, Regulations, and
White Papers".
(c) Failure to conform to paragraph (a) of this clause may result in a
reduction in the service charge, if appropriate, and corrective action to
protect the interest of Federal Members. Corrective action will be
appropriate to the circumstances and may include, but is not limited to the
following actions by OPM:
(1) Directing the Carrier to cease and desist distribution, publication, or
broadcast of the material;
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(2) Directing the Carrier to issue corrections at the Carrier's expense and in
the same manner and media as the original material was made; and
(3) Directing the Carrier to provide, at the Carrier's expense, the correction
in writing by certified mail to all enrollees of the Plan(s) that had been
the subject of the original material.
(d) Egregious or repeated offenses may result in the following action by OPM:
(1) Suspending new enrollments in Carrier's Plan(s);
(2) Providing Enrollees a opportunity to transfer to another plan; and
(3) Terminating the contract in accordance with Section 1.15 of the Tufts/OPM
contract, RENEWAL AND WITHDRAWAL OF APPROVAL.
(e) Prior to taking action as described in paragraph (c) and (d) of this
clause, the OPM will notify Carrier and offer an opportunity to respond.
(f) Carrier shall incorporate this clause in subcontracts with its underwriter,
if any, and other subcontractors directly involved in the preparation or
distribution of such advertising material and shall substitute an
appropriate reference for the term "Carrier".
4. FEBHP Contract Section 5.5
ANTI-KICKBACK PROCEDURES
(a) Definitions.
"Kickback", as used in this clause, means any money, fee, commission,
credit, gift, gratuity, thing of value, or compensation of any kind which
is provided, directly or indirectly, to Carrier, Carrier employee,
subcontractor, or subcontractor employee for the purpose of improperly
obtaining or rewarding favorable treatment in connection with a prime
contract or in connection with a subcontract relating to a prime contract.
"Person", as used in this clause, means a corporation, partnership,
business association of any kind, trust, joint-stock company, or
individual.
"Prime contract", as used in this clause, means a contract or contractual
action entered into by the United States for the purpose of obtaining
supplies, materials, equipment, or services of any kind.
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"Prime Contractor", as used in this clause, means a person who has entered
into a prime contract with the United States.
"Prime Contractor employee", as used in this clause, means any officer,
partner, employee, or agent of a prime Contractor.
"Subcontract", as used in this clause, means a contract or contractual
action entered into by a Prime Contractor or a subcontractor for the
purpose of obtaining supplies, materials, equipment, or services of any
kind under a prime contract.
"Subcontractor", as used in this clause, (1) means any person, other than
the Prime Contractor, who offers to furnish or furnishes any supplies,
materials, equipment, or services of any kind under a prime contract or a
subcontract entered into in connection with such prime contract, and (2)
includes any person who offers to furnish or furnishes general supplies to
Prime Contractor or a higher tier subcontractor.
"Subcontractor employee", as used in this clause, means any officer,
partner, employee, or agent of a subcontractor.
(b) The Anti-Kickback Act of 1986 (41 U.S.C. 51-58) (the Act), prohibits any
person from --
(1) Providing or attempting to provide or offering to provide any kickback;
(2) Soliciting, accepting, or attempting to accept any kickback; or
(3) Including, directly or indirectly, the amount of any kickback in the
contract price charged by the Prime Contractor to the United States or in
the contract price charged by a subcontractor to a Prime Contractor for
higher tier subcontractor.
(c)
(1) The Prime Contractor shall have in place and follow reasonable procedures
designed to prevent and detect possible violations described in paragraph
(b) of this clause in its own operations and direct business relationships.
(2) When the Prime Contractor has reasonable grounds to believe that a
violation described in paragraph (b) of this clause may have occurred, the
Contractor shall promptly report in writing the possible violation. Such
reports shall be made to the inspector general of the
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contracting agency; the head of the contracting agency if the agency does
not have an inspector general, or the Department of Justice.
(3) The Prime Contractor shall cooperate fully with any Federal agency
investigating a possible violation described in paragraph (b) of this
clause.
(4) The Contracting Officer may (i) offset the amount of the kickback against
any monies owed by the United States under the prime contract and/or (ii)
direct that the Prime Contractor withhold, from sums owed a subcontractor
under the prime contract, the amount of any kickback. the Contracting
Officer may order the monies withheld under subdivision (c)(4)(i) of this
clause. In either case, the Prime Contractor shall notify the Contracting
Officer when the monies are withheld.
(5) The Prime Contractor agrees to incorporate the substance of this clause,
including this subparagraph (c)(5) but excepting subparagraph (c)(1), in
all subcontracts under this contract which exceed $100,000.
5. FEHBP Contract Section 5.7
AUDIT AND RECORDS-NEGOTIATION
(a) As used in this clause, "records" includes books, documents, accounting
procedures and practices, and other data, regardless of type and regardless
of whether such items are in written form, in the form of computer data, or
in any other form.
(b) EXAMINATION OF COSTS. If this is a cost-reimbursement, incentive,
time-and-materials, labor-hour, or price redeterminable contract, or any
combination of these, Carrier shall maintain and the Contracting Officer,
or an authorized representative of the Contracting Officer, shall have the
right to examine and audit all records and other evidence sufficient to
reflect properly all costs claimed to have been incurred or anticipated to
be incurred directly or indirectly in performance of this contract. This
right of examination shall include inspection at all reasonable times of
Carrier's plants, or parts of them, engaged in performing the contract.
(c) COST OR PRICING DATA. If Carrier has been required to submit cost or
pricing data in connection with any pricing action relating to this
contract, the Contracting Officer, or an authorized representative of the
Contracting Officer, in order to evaluate the accuracy, completeness, and
currency of the cost or pricing data, shall have the right to examine and
audit all of Carrier's records, including computations and projections,
related to--
(1) The proposal for the contract, subcontract, or modification;
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(2) The discussions conducted on the proposal(s), including those related to
negotiating;
(3) Pricing of the contract, subcontract, or modification; or
(4) Performance of the contract, subcontract or modification.
(d) COMPTROLLER GENERAL - (1) The Comptroller General of the United States, or
an authorized representative, shall have access to and the right to examine
any of Carrier's directly pertinent records involving transactions related
to this contract or a subcontract hereunder.
(1) This paragraph may not be construed to require Carrier or a subcontractor
to create or maintain any record that Carrier or a subcontractor of Carrier
does not maintain in the ordinary course of business or pursuant to a
provision of law.
(e) REPORTS. If Carrier is required to furnish cost, funding, or performance
reports, the Contracting Officer or an authorized representative of the
Contracting Officer shall have the right to examine and audit the
supporting records and materials, for the purpose of evaluating (1) the
effectiveness of Carrier's policies and procedures to produce data
compatible with the objectives of these reports and (2) the data reported.
(f) AVAILABILITY. Carrier shall make available at its office at all reasonable
times the records, materials, and other evidence described in paragraph
(a), (b), (c), (d), and (e) of this clause, for examination, audit, or
reproduction, until 3 years after final payment under this contract or for
any shorter period specified in Subpart 4.7, Contractor Records Retention,
of the Federal Acquisition Regulation (FAR), or for any longer period
required by statute or by other clauses of this contract. In addition--(1)
If this contract is completely or partially terminated, Carrier shall make
available the records relating to the work terminated until 3 years after
any resulting final termination settlement; and (2) Carrier shall make
available records relating to appeals under the Disputes clause or to
litigation or the settlement of claims arising under or relating to this
contract until such appeals, litigation, or claims are finally resolved.
(g) Carrier shall insert a clause containing all the terms of this clause,
including this paragraph (g), in all subcontracts under this contract that
exceed the simplified acquisition threshold and--
(1) That are cost-reimbursement, incentive, time-and-materials, labor-hour, or
price-redeterminable type or any combination of these;
(2) For which cost or pricing data are required; or
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(3) That require the subcontractor to furnish reports as discussed in paragraph
(e) of this clause.
The clause may be altered only as necessary to identify properly the
contracting parties and the Contracting Officer under the Government prime
contract.
6. FEHBP Contract Section 5.18:
CONTRACT WORK HOURS AND SAFETY STANDARDS ACT - OVERTIME COMPENSATION
(a) OVERTIME REQUIREMENTS. No Contractor or any subcontractor employing
laborers or mechanics (see Federal Acquisition Regulation 22.300) shall
require or permit them to work over 40 hours in any workweek unless they
are paid at least 1 and 1/2 times the basic rate of pay for reach hour
worked over 40 hours.
(b) VIOLATION: LIABILITY FOR UNPAID WAGES; LIQUIDATED DAMAGES. The responsible
Contractor and subcontractor are liable for unpaid wages if they violate
the terms in paragraph (a) of this clause. In addition, the Contractor and
subcontractor are liable for unpaid wages if they violate the terms in
paragraph (a) of this clause. In addition, the Contractor and subcontractor
are liable for liquidated damages payable to the Government. The
Contracting Officer will assess liquidated damages at the rate of $10 per
affected employee for each calendar day on which the employer required or
permitted the employee to work in excess of the standard workweek of 40
hours without paying overtime wages required by the Contract Work Hours and
Safety Standards Act.
(c) WITHHOLDING FOR UNPAID WAGES AND LIQUIDATED DAMAGES. The Contracting
Officer will withhold from payments due under the contract sufficient funds
required to satisfy Contractor or subcontractor liabilities for unpaid
wages and liquidated damages. If amounts withheld under the contract are
insufficient to satisfy Contractor's or subcontractor liabilities, the
Contracting Officer will withhold payments from other Federal or Federally
assisted contracts held by the same Contractor that are subject to the
Contract Work Hours and Safety Standards Act.
(d) Payrolls and basic records. (1) The Contractor and its subcontractors shall
maintain payrolls and basic payroll records for all laborers and mechanics
working on the contract during the contract and shall make them available
to the Government until 3 years after contract completion. The records
shall contain the name and address of each employee, social security
number, labor classifications, hourly rates of wages paid, daily and weekly
number of hours worked, deductions made, and actual wages paid. The records
need not duplicate those required for construction
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work by Department of Labor regulations at 29 CFR 5.5(a)(3) implementing
the Xxxxx-Xxxxx Act.
(e) The Contractor and its subcontractors shall allow authorized
representatives of the Contracting Officer or the Department of Labor to
inspect, copy, or transcribe records maintained under paragraph (d)(1) of
this clause. The Contractor or subcontractor also shall allow authorized
representatives of the Contracting Officer or Department of Labor to
interview employees in the workplace during working hours.
(f) Subcontracts. The Contractor and its subcontractors shall insert the
provisions set forth in paragraph (a) through (d) of this clause in
subcontracts exceeding $100,000 and require subcontractors to include these
provisions in any lower-tier subcontracts. The Contractor shall be
responsible for compliance by any subcontractor or lower-tier subcontractor
with the provisions set forth in paragraph (a) through (d) of this clause.
7. FEHBP Contract Section 5.22
AFFIRMATIVE ACTON FOR DISABLED VETERANS AND VETERANS OF THE VIETNAM ERA
(a) Definitions as used in this clause-
"All employment openings" includes all positions except executive and top
management, those positions that will be filled from within the
contractor's organization, and positions lasting 3 days or less. This term
includes full-time employment, temporary employment of more than 3 days'
duration, and part-time employment.
"Appropriate office of the State employment service system", means the
local office of the Federal-State national system of public employment
offices with assigned responsibility to serve the area where the employment
opening is to be filled, including the District of Columbia, Guam, the
Commonwealth of Puerto Rico, and the Virgin Islands.
"Positions that will be filled from within the Contractor's organization"
means employment openings for which no consideration will be given to
persons outside the Contractor's organization (including any affiliates,
subsidiaries, and parent companies) and includes any openings that the
Contractor proposes to fill from regularly established "recall" lists. The
exception does not apply to a particular opening once an employer decides
to consider applicants outside of its organization.
"Veteran of the Vietnam era" means a person who-
(1) Served on active duty for a period of more than 180 days, any part of which
occurred between August 5, 1964, and May 7, 1975, and
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was discharged or released therefrom with other than a dishonorable
discharge; or
(2) Was discharged or released from active duty for a service-connected
disability if any part of such active duty was performed between August 5,
1964 and May 7, 1975.
(b) GENERAL. (1) Regarding any position for which the employee or applicant for
employment is qualified, the Contractor shall not discriminate against the
individual because the individual is a disabled veteran or a veteran of the
Vietnam Era. The Contractor agrees to take affirmative action to employ,
advance in employment, and otherwise treat qualified disabled veterans and
veterans of the Vietnam Era without discrimination based upon their
disability or veterans' status in all employment practices such as
(i) Employment;
(ii) Upgrading;
(iii) Demotion or transfer;
(iv) Recruitment;
(v) Advertising;
(vi) Layoff or termination;
(vii) Rates of pay or other forms of compensation; and
(viii) Selection for training, including apprenticeship.
(2) The Contractor agrees to comply with the rules, regulations, and relevant
orders of the Secretary of Labor (Secretary) issued under the Vietnam Era
Veterans' Readjustment Assistance Act of 1972 (the Act), as amended.
(c) LISTING OPENINGS. (1) Carrier agrees to list all employment openings
existing at contract award or occurring during contract performance, at an
appropriate office of the State employment service system in the locality
where the opening occurs. These openings include those occurring at any
Contractor facility, including one not connected with performing this
contract. An independent corporate affiliate is exempt from this
requirement.
(1) State and local government agencies holding Federal contracts of $10,000 or
more shall also list all employment openings with the appropriate office of
the State employment service.
B-10
(2) The listing of employment openings with the State employment service system
is required at least concurrently with using any other recruitment source
or effort and involves the obligations of placing a bona fide job order,
including accepting referrals of veterans and non-veterans. This listing
does not require hiring any particular job applicant or hiring from any
particular group of job applicants and is not intended to relieve
Contractor from any requirements of Executive orders or regulations
concerning nondiscrimination in employment.
(3) Whenever Contractor becomes contractually bound to the listing terms of
this clause, it shall advise the State employment service system, in each
State where it has establishments of the name and location of each hiring
location in the State. As long as Contractor is contractually bound to
these terms and has so advised the State system, it need not advise the
State system of subsequent contracts. Contractor may advise the State
system when it is no longer bound by this contract clause.
(d) APPLICABILITY. This clause does not apply to the listing of employment
openings that occur and are filled outside the 50 States, the District of
Columbia, the Commonwealth of Puerto Rico, Guam, and the Virgin Islands.
(e) POSTINGS. (1) Contractor agrees to post employment notices stating (i)
Contractor's obligation under the law to take affirmative action to employ
and advance in employment qualified disabled veterans and veterans of the
Vietnam era, and (ii) the rights of applicants and employees.
(1) These notices shall be posted in conspicuous places that are available to
employees and applicants for employment. They shall be in a form prescribed
by the Deputy Assistant Secretary for Federal Contract Compliance Programs,
Department of Labor (Deputy Assistant Secretary), and provided by or
through the Contracting Officer.
(2) Contractor shall notify each labor union or representative of workers with
which it has a collective bargaining agreement or other contract
understanding, that the Contractor is bound by the terms of the Act, and is
committed to take affirmative action to employ, and advance in employment,
qualified disabled veterans and veterans of the Vietnam era.
(f) NONCOMPLIANCE. If the Contractor does not comply with the requirements of
this clause, appropriate actions may be taken under the rules, regulations,
and relevant orders of the Secretary issued pursuant to the Act.
(g) SUBCONTRACTS. The Contractor shall include the terms of this clause in
every subcontract or purchase order of $10,000 or more unless exempted by
rules, regulations, or orders of the Secretary. The Contractor shall act as
B-11
specified by the Deputy Assistant Secretary to enforce the terms, including
action for noncompliance.
8. FEHBP Contract Section 5.23
AFFIRMATIVE ACTION FOR WORKERS WITH DISABILITIES
(a) General.
(1) Regarding any position for which the employee or applicant for employment
is qualified, the Contractor shall not discriminate against any employee or
applicant because of physical or mental disability. the Contractor agrees
to take affirmative action to employ, advance in employment, and otherwise
treat qualified individuals with disabilities without discrimination based
upon their physical or mental disabilities in all employment practices such
as -
(i) Recruitment. Advertising, and job application procedures;
(ii) Hiring, upgrading, promotion, award of tenure, demotion, transfer,
layoff, termination, right of return from layoff, and rehiring;
(iii) Rates of pay or any other form of compensation and changes in
compensation;
(iv) Job assignments, job classifications, organizational structures, position
descriptions, lines of progression, and seniority lists;
(v) Leaves of absence, sick leave, or any other leave;
(vi) Fringe benefits available by virtue of employment, whether or not
administered by the Contractor;
(vii) Selection and financial support for training, including apprenticeships,
professional meetings, conferences , and other related activities, and
selections for leaves of absence to pursue training;
(viii) Activities sponsored by the Contractor, including social or recreational
programs; and
(ix) Any other term, condition, or privilege of employment.
(2) The Contractor agrees to comply with the rules, regulations, and relevant
orders of the Secretary of Labor (Secretary) issued under the
Rehabilitation Act of 1973 (29 U.S.C. 793) (the Act), as amended.
B-12
(b) POSTING.
(1) The Contractor agrees to post employment notices stating (i) the
Contractor's obligation under the law to take affirmative action to employ
and advance in employment qualified individuals with disabilities, and (ii)
the rights of applicants and employees.
(2) These notices shall be posted in conspicuous places that are available to
employees and applicants for employment. The Contractor shall ensure that
applicants and employees with disabilities are informed of the contents of
the notice (e.g., the Contractor may have the notice read to a visually
disabled individual, or may lower the posted notice so that it might be
read by a person in a wheelchair). The notices shall be in a form
prescribed by the Deputy Assistant Secretary for Federal Contract
Compliance of the U.S. Department of Labor (Deputy Assistant Secretary),
and provided by or through the Contracting Officer.
(3) The Contractor shall notify each labor union or representative of workers
with which it has a collective bargaining agreement or other contract
understanding, that the Contractor is bound by the terms of Section 503 of
the Act and is committed to take affirmative action to employ, and advance
in employment, qualified individuals with disabilities.
(c) NONCOMPLIANCE. If the Contractor does not comply with the requirements of
this clause, appropriate actions may be taken under the rules, regulations,
and relevant orders of the Secretary issued pursuant to the Act.
(d) SUBCONTRACTS. The Contractor shall include the terms of this clause in
every subcontract or purchase order of $10,000 or more unless exempted by
rules, regulations, or orders of the Secretary. The Contractor shall act as
specified by the Deputy Assistant Secretary to enforce the terms, including
action for noncompliance.
9. FEHBP Contract Section 5.56
AUTHORIZATION AND CONSENT
(a) The Government authorizes and consents to all use and manufacture, in
performing this contract or any subcontract at any tier, of any invention
described in or covered by a United States patent (1) embodied in the
structure or composition of any article the delivery of which is accepted
by the Government under this contract or (2) used in machinery, tools or
methods whose use necessarily results from compliance by the Contractor for
a subcontractor with (i) specifications or written provisions forming a
part of this contract or (ii) specific written instructions given by the
Contracting Officer directing the manner of performance. The entire
liability to the Government for infringement of a patent of the United
States shall be
B-13
determined solely by the provisions of the indemnity clause, if any,
included in this contract or subcontract hereunder (including any
lower-tier subcontract), and the Government assumes liability for all other
infringement to the extent of the authorization and consent hereinabove
granted.
(b) Carrier agrees to include, and require inclusion of, this clause, suitably
modified to identify the parties, in all subcontracts at any tier for
supplies or services (including construction, architect-engineer services,
and materials, supplies, models, samples, and design or testing services
expected to exceed the simplified acquisition threshold); however, omission
of this clause from any subcontract, including those at or below the
simplified acquisition threshold, does not affect this authorization and
consent.
10. FEHBP Contract Section 5.57
NOTICE AND ASSISTANCE REGARDING PATENT AND COPYRIGHT INFRINGEMENT
(a) The Contractor shall report to the Contracting Officer, promptly and in
reasonable written detail, each notice or claim of patent or copyright
infringement based on the performance of this contract of which the
Contractor has knowledge.
(b) In the event of any claim or suit against the Government on account of any
alleged patent or copyright infringement arising out of the performance of
this contract or out of the use of any supplies furnished or work or
services performed under this contract, the Contractor shall furnish to the
Government, when requested by the Contracting Officer, all evidence and
information in possession of the Contractor pertaining to such suit or
claim. Such evidence and information shall be furnished at the expense of
the Government except where the Contractor has agreed to indemnify the
Government.
(c) The Contractor agrees to include, and require inclusion of, this clause, in
all subcontracts at any tier for supplies or services (including
construction and architect-engineer subcontracts and those for materials,
supplies, models, samples, or design or testing services) expected to
exceed the simplified acquisition threshold at FAR 2.101.
11. FEHBP Contract Section 5.59
PROHIBITION OF SEGREGATED FACILITIES
(a) "Segregated facilities", as used in this clause, means any waiting rooms,
work areas, rest rooms and wash rooms, restaurants and other eating areas,
time clocks, locker rooms and other storage or dressing areas, parking
lots, drinking fountains, recreation or entertainment areas,
transportation, and housing facilities provided for employees, that are
segregated by explicit
B-14
directive or are in fact segregated on the basis of race, color, religion,
sex, or national origin because of written or oral policies or employee
custom. The term does not include separate or single-user rest rooms or
necessary dressing or sleeping areas provided to assure privacy between the
sexes.
(b) The Contractor agrees that it does not and will not maintain or provide for
its employees any segregated facilities at any of its establishments, and
that it does not and will not permit its employees to perform their
services at any location under its control where segregated facilities are
maintained. The Contractor agrees that a breach of this clause is a
violation of the Equal Opportunity clause in this contract.
(c) The Contractor shall include this clause in every subcontract and purchase
order that is subject to the Equal Opportunity clause of this contract.
B-15
EXHIBIT C
BUSINESS ASSOCIATION ADDENDUM
BUSINESS ASSOCIATE ADDENDUM
This Business Associate Addendum ("Addendum") is entered into by and
between Alere Medical, Inc. ("Alere"), acting as Tuft's general contractor
for disease management services and Subcontractor ("Business Associate")
and hereby supplements, amends, and is made a part of any and all HIPAA
Related Agreements. The term "HIPAA Related Agreements" means any and all
agreements (in effect as of the date of full execution of this Addendum
("Effective Date") or entered into any time thereafter) by and between
Business Associate and Alere under which Business Associate has created or
received and/or may create or receive Protected Health Information (as
defined below) from or on behalf of Tufts either directly or indirectly
through Alere.
RECITALS
A. Alere and/or Business Associate are parties to the HIPAA Related Agreements
pursuant to which Business Associate and/or Alere provide certain services
to Tufts, and, in connection with those services, Tufts and/or Alere
discloses to Business Associate certain protected health information as
defined at 45 CFR ss. 160.103 (the "Protected Health Information") that is
subject to protection under the Health Insurance Portability and
Accountability Act of 1996 ("HIPAA," found at Public Law 104-191), and
certain regulations promulgated by the U.S. Department of Health and Human
Services to implement certain provisions of HIPAA (the "HIPAA Privacy
Rule," 45 CFR Part 160 and 45 CFR Part 164, subparts "A" and "E" and the
"HIPAA Security Rule," 45 CFR Part 160 and 45 CFR Part 164, subparts "A"
and "C," collectively, the "HIPAA Regulations").
X. Xxxxx is a "covered entity," as that term is defined in the HIPAA Privacy
Rule. Business Associate, as recipient of Protected Health Information from
Tufts under the HIPAA Related Agreements, is a "business associate" of
Tufts, as that term is defined in the HIPAA Privacy Rule.
C. Pursuant to the HIPAA Privacy Rule, all business associates of Tufts, as a
condition of doing business with Tufts, must agree in writing to certain
mandatory provisions regarding, among other things, the use and disclosure
of Protected Health Information. The parties agree that the obligations
specified herein shall commence upon the Effective Date.
D. The purpose of this Addendum is to satisfy the requirements of the HIPAA
Regulations.
D-1
IN CONSIDERATION OF THE FOREGOING, and the mutual promises and
covenants contain herein, the parties agree as follows:
AGREEMENT
1. DEFINITIONS. Unless otherwise provided in this Addendum, capitalized
terms have the same meaning as set forth in the HIPAA Privacy Rule.
2. APPLICABILITY. This Addendum shall be applicable to Protected Health
Information (i) received by Business Associate from Tufts and/or Alere
pursuant to the HIPAA Related Agreements or (ii) created or received by
Business Associate on behalf of Tufts and/or Alere pursuant to the HIPAA
Related Agreements.
3. SCOPE OF USE OF PROTECTED HEALTH INFORMATION. Business Associate shall
not use or disclose Protected Health Information for any purpose other
than:
(i) As permitted or required by the HIPAA Related Agreements (including
this Addendum);
(ii) to and/or at the direction of Tufts and Alere, as required to perform
the HIPAA related Agreements,
(iii) As otherwise required by law;
(iv) The proper management and administration of Business Associate;
(v) Business Associate may aggregate PHI with such information of other
covered entities which Business Associate has received or created in
its capacity as a business associate of such other covered entities
provided that the purpose of the aggregation is to provide each
covered entity with data analysis related to the respective covered
entities' health care operations and provided further that the PHI
disclosed hereunder for such purposes shall not be disclosed in the
data analysis provided to any other covered entity;
(vi) Business Associate may de-identify PHI provided that Business
Associate provided that Business Associate satisfied the applicable
provisions for de-identification under HIPAA. Any such de-identified
information shall not constitute PHI and shall not be subject to the
terms and conditions of this Agreement. Notwithstanding any other
provision of this Agreement, de-identified information created or
derived by Business Associate, including PHI of or provided by Tufts
or Alere, shall be Confidential Information of Business Associate,
and may be used or disclosed by Business Associate during the Term or
thereafter for any lawful purpose. Neither Tufts nor Alere shall have
any right, title or interest in or to such de-identified information.
4. SAFEGUARDS FOR THE PROTECTION OF PROTECTED HEALTH INFORMATION. Business
Associate shall implement and use appropriate safeguards, including
D-2
but not limited any and all such safeguards directed by Tufts and/or Alere,
to help ensure that Protected Health Information is not used or disclosed
by Business Associate, or by any subcontractors, affiliates, or business
associates of Business Associate, except as provided in the HIPAA Related
Agreements (including this Addendum).
5. REPORTING OF UNAUTHORIZED USES OR DISCLOSURES. Business Associate shall
promptly report to Tufts and Alere any use or disclosure of Protected
Health Information by Business Associate or its subcontractors of which
Business Associate becomes aware that is not provided for or permitted in
the HIPAA Related Agreements (including this Addendum). Business Associate
shall permit Alere and Tufts reasonable access to Business Associate's
employees and records (including electronic records) as reasonably
necessary to investigate any such report.
6. USE OF SUBCONTRACTORS. To the extent that any HIPAA Related Agreement
expressly permits Business Associate to use subcontractors and/or agents to
perform its obligations under such HIPAA Related Agreement or to otherwise
delegate performance of its obligations (if at all), Business Associate
shall cause each such subcontractor, agent or delegatee to sign and shall
ensure their compliance with an agreement with Business Associate
containing the same provisions and conditions related to the protection and
confidentiality of Protected Health Information as those that apply to
Business Associate under the applicable HIPAA Related Agreements (including
this Addendum).
7. AUTHORIZED ACCESS TO PROTECTED HEALTH INFORMATION. To the extent that
Business Associate maintains Protected Health Information in a Designated
Record Set, at the request of Tufts and/or Alere, Business Associate shall
provide Tufts and Alere (or an Individual as directed by Tufts or Alere)
access to such Protected Health Information in a Designated Record Set in
the time and manner reasonably designated by Tufts and/or Alere in order
for Tufts to meet the requirements imposed on Tufts by 45 CFR ss. 164.524.
8. AMENDMENT OF PROTECTED HEALTH INFORMATION. To the extent that Business
Associate maintains Protected Health Information in a Designated Record
Set, Business Associate shall make any amendment(s) to Protected Health
Information in a Designated Record Set that Tufts and/or Alere directs or
agrees to pursuant to 45 CFR ss. 164.526, and in the time and manner
reasonably designated by Tufts and/or Alere; provided, however, if Business
Associates believes that such amendment would render its records
inaccurate, it shall make the amendment but place a notation in the record
as to the disagreement.
9. ACCOUNTING OF DISCLOSURES OF PROTECTED HEALTH INFORMATION. Business
Associate shall keep records of all disclosures of Protected Health
Information
D-3
made by Business Associate (the "Disclosure Accounting") on an ongoing
basis for a period of at least six (6) years (or such longer period as may
be required by the HIPAA Related Agreements or by applicable law), except
for disclosures:
(i) To carry out Treatment, Payment, or Health Care Operations, as
provided in 45 CFR ss. 164.502;
(ii) To individuals of Protected Health Information about them as provided
in 45 CFR ss. 164.502;
(iii) That are otherwise excluded from the HIPAA Privacy Rule disclosure
accounting requirements by the provisions set forth at 45 CFR ss.
164.528(a)(1), subsection (iii) through (ix); or
(iii) That occurred prior to April 14, 2003.
At a minimum, the Disclosure Accounting shall contain:
(a) The date of the disclosure;
(b) The name of the entity or person to whom or which the Protected Health
Information was provided and, if known, the address of such entity or
person;
(c) A brief description of the Protected Health Information disclosed; and
(d) A brief statement of the purpose of the disclosure that reasonably informs
the Individual of the basis for the disclosure or, in lieu of such
statement, a copy of the Individual's written authorization or request for
disclosure pursuant to the HIPAA Privacy Rule.
Business Associate shall provide the Disclosure Accounting to
Tufts and Alere (or to an Individual, if so directed by Tufts or Alere)
within sixty (60) days of receiving a written request therefor from Tufts
or Alere.
10. RIGHT TO AUDIT. Upon the request of Tufts and/or the Secretary of the
Department of Health and Human Services, Business Associate shall make its
practices, books and records related to Protected Health Information
available to Tufts and/or the Secretary of the Department of Health and
Human Services for the purpose of determining Tuft's compliance with the
HIPAA Regulations and/or Business Associate's compliance with this
Addendum.
11. FUTURE CONFIDENTIALITY OF PROTECTED HEALTH INFORMATION. Upon the
expiration or earlier termination of any HIPAA Related Agreement for any
reason, Business Associate shall return to Tufts, or, at Tuft's direction,
delete, purge and destroy, all Protected Health Information (in any form,
recorded on any medium, or stored in any storage system) that was created
or obtained pursuant to that terminated HIPAA Related Agreement (and that
Business Associate does not need to maintain to perform its obligations
under any then-existing HIPAA Related Agreement) and shall retain no copies
of such information. If Business Associate destroys Protected Health
Information, an officer of Business Associate shall certify such
destruction to Tufts in writing.
D-4
If such return or destruction is not feasible, Business Associate shall
extend the protections of this Addendum to the information and shall limit
further uses and disclosures to those purposes that make the return or
destruction of the information infeasible.
12. TERMINATION IN EVENT OF BREACH. In the event that Business Associate
violates any material term of any HIPAA Related Agreement (including this
Addendum, Tufts and/or Alere may terminate the HIPAA Related Agreement(s)
immediately by providing written notice of such termination to Business
Associate.
13. INDEMNIFICATION. Business Associate agrees that it shall be financially
responsible for, and agrees that it shall defend, indemnify, and hold
harmless, Tufts and Alere (including for each, its corporate affiliates and
each of its and their shareholders, affiliates, officers, directors,
employees, agents, attorneys, successors, successors-in-interest, and
assigns) from and against any and all claims, causes of action, suits,
litigation, proceedings, complaints, demands, charges, liens, disputes,
obligations, damages, losses, debts, indebtedness, liabilities, costs
(including settlement costs and costs of investigation), expenses and fees
(including reasonable attorneys' fees) arising out of or in connection with
Business Associate's actions and omissions involving Protected Health
Information relating to enrollees, subscribers, insureds, customers, or
patients of Tufts. The provisions of this Section 13 shall survive the
expiration or earlier termination of this Addendum.
14. PROVISIONS APPLICABLE TO EPHI. Business Associate agrees that it shall:
5.1 Implement administrative, physical, and technical safeguards
that reasonably and appropriately protect the confidentiality, integrity,
and availability of the Electronic Protected Health Information that it
creates, receives, maintains, or transmits on behalf of Tufts as required
by 45 CFR, Part 164, Subpart "C."
5.2 Require that any agent, including a subcontractor, to whom
Business Associate provides Electronic Protected Health Information agrees
to implement reasonable and appropriate safeguards to protect such
Electronic Protected Health Information; provided, however, that Business
Associate shall not assign, delegate, or subcontract any obligation of
Business Associate owed to Tufts in violation of any HIPAA Related
Agreement;
5.3 Immediately report to Tufts and Alere any Security Incident of
which Business Associate becomes aware.
15. AMENDMENTS. The parties shall negotiate in good faith any amendments to
this Addendum or a replacement of this Addendum to the extent necessary in
order to maintain compliance with applicable laws and regulations.
D-5
16. EFFECT ON HIPAA RELATED AGREEMENTS. Except as amended herein, all terms
of all of the HIPAA Related Agreements shall remain in full force and
effect.
17. CONSTRUCTION. Any ambiguity in this Addendum shall be resolved in favor
of a meaning that complies with HIPAA and the HIPAA Regulations.
18. COUNTERPARTS. This Addendum may be executed in any number of
counterparts, all of which taken together shall constitute one single
agreement between the parties.
IN WITNESS WHEREOF, the parties hereto have caused this Business
Associate Addendum to be executed as of the Effective Date.
SUBCONTRACTOR
By:
------------------------------------
Title:
---------------------------------
ALERE
By:
------------------------------------
Title:
---------------------------------
D-6
STATEMENT OF WORK
FOR
CARE MANAGEMENT SERVICES
DISEASE MANAGEMENT SERVICES
This Statement of Work for Care Management Services (this "SOW") is
entered into as of October 16, 2006 (the "SOW Effective Date") between Alere
Medical, Inc. ("Alere") and Enhanced Care Initiatives, Inc. ("ECI"), and is a
part of that certain Disease Management Services Agreement dated as of October
16, 2006 between ECI and Alere (the "DMSA"). This SOW sets forth the
assumptions, expectations, Services and Deliverables to be provided by, and
compensation to be paid to, ECI in connection with ECI's provision of disease
management services to Alere. Capitalized terms used but not defined in this SOW
shall have the respective meanings set forth in the DMSA.
1. DEFINITIONS. In addition to the terms otherwise defined herein or in the
DMSA, the following terms shall have the meanings ascribed to them:
"Care Management Program" shall mean the program maintained by ECI
pursuant to which ECI provides Care Management Services.
"Care Management Services" shall mean a nurse-based program of care
managed designed to promote the health of the patient while reducing the
associated costs of treatment by focusing of active management of preventive
health measures that will result in less frequent hospitalizations.
"Program Participants" means those persons who are Enrollees and who
are identified by ECI and Alere as individuals admitted into the Care Management
Program.
" Enrollees" shall mean all individuals during the relevant period who
were enrolled in any medical care plan with which Tufts Health Plan or a Tufts
Health Plan Affiliates have contracted to provide medical services.
2. CARE MANAGEMENT SERVICES. ECI shall provide or arrange for the provision of
Care Management Services, as set forth below, to Enrollees who become Program
Participants, and in coordination with the respective primary care and/or
treating physicians of the Program Participants.
The Care Management Service provided by ECI is a nurse-based program
that supports the services provided by health care providers with individual
Care Management for chronically ill patients. The objective of the program is to
reduce the incidence of hospitalization among patients with some combination of
congestive heart failure, diabetes, respiratory disease, or other illnesses,
through individual monitoring, behavioral modification and preventive health
measures.
ECI nursing personnel receive special training in accordance with the
confidential and proprietary training materials contained in the ECI
Professional Training Manual.
D-7
ECI will staff the Care Management Program with one full-time equivalent for
each one hundred (100) Program Participants, plus a number of support staff both
within the community and at the ECI central office.
The Care Management Nurse will meet with each Program Participant on an
intermittent basis ranging from daily to bimonthly, and will record pertinent
information utilizing a confidential and proprietary Patient Information System
operating upon a hand-held computer.
The Care Management Services also include weekly physical
therapy/recreational group sessions with each Program Participant during which
the Care Management Nurse will be assisted by physical therapists, nursing
assistants and/or other staff.
Program Participants will be selected for participation in the Care
Management Program based upon criteria assessed using the confidential and
proprietary Selection Criteria developed by ECI and approved by ALERE.
Where services are delivered in the home and community centers, ECI
provides the following:
1. Care coordination to improve adherence to the plan of care.
2. Availability of on call nurse 24/7 for Program Participants.
3. Connecting care: ECI personnel visit the doctor with the patient.
4. Disease-specific exercise prescriptions: working in collaboration with
the patient's physician and physical therapist.
5. Home safety programs.
6. Close collaboration with the family and caregivers.
7. Health and Disease-specific education for patient and caregiver.
8. 24/7 Caregiver Support Program.
9. Initiating Health Monitoring systems (Medi-monitor - an electronic
medication monitoring and prompting device, scales, etc.)
10. Safe use of Medications.
11. Pharmacist medication review.
12. Geriatrician oversight.
13. Monitoring adherence to established care guidelines.
14. Communicating and coordinating care issues with providers.
15. Community patient wellness program - weekly community based meetings -
decreasing isolation and depression.
D-8
16. Advanced Directives education.
17. Care Management Functions.
a. ECI personnel function as a true and trusted patient advocacy - best
able to assist with appropriate care coordination and use of resources.
b. ECI personnel are able to advocate for the patient in the ER,
Hospital, Skilled Nursing Facility or Rehabilitation Facility.
c. ECI personnel can assist in maximizing appropriate use of community
resources and limiting unnecessary institutional care.
ECI shall provide Alere with reports as outlined in the Table 1 below:
TABLE 1
Outcomes Reporting Metrics and Schedule
====================================================================================================================
1. Outcomes METRICS DATA SOURCE REPORTING FREQUENCY
--------------------------------------------------------------------------------------------------------------------
REFERRALS Referral sources (# of patients ECI system data Monthly
referred by claims, ad-hoc, etc)
--------------------------------------------------------------------------------------------------------------------
Referral outcomes: disposition of ECI system data Monthly
referred patients
--------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------
ENROLLMENT Enrollment activity: enrolled,
disenrolled and net ECI system data Monthly
--------------------------------------------------------------------------------------------------------------------
Number of patients disenrolled and
reasons ECI system data Monthly
--------------------------------------------------------------------------------------------------------------------
Average length of enrollment ECI system data Monthly
--------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------
CENSUS Total active membership during the
period ECI system data Monthly
--------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------
UTILIZATION All-cause inpatient admissions PTMPY
for eligible patients Claims Semi-annual
--------------------------------------------------------------------------------------------------------------------
All-cause ER visits PTMPY for
eligible patients Claims Semi-annual
--------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------
FINANCIAL Total healthcare costs compared to
the baseline Claims Annually
--------------------------------------------------------------------------------------------------------------------
Annual net savings Claims Annually
--------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------
QUALITY OF LIFE Quality of Life scores (SF-12) Self-reported Semi-annual
--------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------
SATISFACTION Patient: Overall satisfaction with
the program Survey Annually
--------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------
Physician: Overall satisfaction Survey Annually
--------------------------------------------------------------------------------------------------------------------
D-9
====================================================================================================================
1. Outcomes METRICS DATA SOURCE REPORTING FREQUENCY
--------------------------------------------------------------------------------------------------------------------
Percent eligible enrolled members
with Pneumococcal Vaccine Self-reported Annually
Percent eligible enrolled members on
a B-Blocker if post MI Self-reported Quarterly
Percent eligible enrolled members
with Atrial Fibrillation on
anticoagulation Self-reported Quarterly
--------------------------------------------------------------------------------------------------------------------
3. DATA EXCHANGE AND ANALYSIS
ALERE DUTIES
a. Alere shall provide ECI with twenty-four (24) months of
medical claims history for the top ten percent (10%) of
Enrollees within each participating Tufts Health Plan
affiliate.
b. Alere will also provide similar information to ECI, a minimum
of quarterly, in order to enable ECI to identify additional
Program Participants. ECI shall meet with the Alere designee
to approve all enrollees in the program. ECI with Alere shall
timely advise such Program Participants and their primary care
and/or treating physicians of the availability of the services
described herein. Alere shall use its best efforts to support
ECI in the process of maintaining and increasing the number of
such Program Participants who may benefit from the Care
Management Programs.
c. Alere will provide ECI with monthly eligibility data for
Program Participants (assuming that data is received by Alere
from Tufts Health Plan in a timely manner)
ECI Duties
a) Assuming the claims data provided to ECI is complete and in the agreed
upon format, ECI agrees to analyze and identify potential Program
Participants and provide Alere with a list (in mutually agreed upon
format) of the identified candidates within 5 business days of receipt
of the claims data.
b) ECI will provide Alere with a weekly enrollment status report (in
mutually agreed upon format) that includes the enrollment status of all
identified Easy Care Program Participants.
4. PERFORMANCE STANDARDS.
D-10
ECI agrees to the following performance standards
o Nurse accompanies 85% of Program Participants to Physician Visits
o 25 % reduction in hospitalizations over a 1 year period of time
o 80% annual flu vacination deployment
o 80 % of Program Participants will have an advanced directive on file
85 % of Program Participants with A. Fibrilation on Anticoagulation
5. COMPENSATION. For the Care Management services delivered Alere will pay ECI a
per Program Participant per month fee of $295.00 based on the total number of
Program Participants enrolled. A Program Participant will be considered enrolled
effective upon the date that they agree to participate in the program.
During 2007 the parties anticipate enrolling a minimum of 350 participants in
the care management program provided by ECI. By November 1, 2006 a more
definitive estimated target enrollment number will be mutually established based
upon participating medical groups and Enrollees who meet the participation
criteria. Commencing January 1, 2007 ALERE shall pay ECI a monthly fee based
upon the estimated total fees payable (based upon the estimated active member
months from the estimated target enrollment established above) during the first
six months of 2007 amortized equally over the first six months. See the example
below:
AMORTIZING A PPPPM MODEL FOR START UP
PPPPM = $295.00
Jan Feb Mar Apr May Jun
New Program Participants 0 175 175 0 0 0
Total Program
Participants 0 175 350 350 350 350
Cumulative Program
Participant Months 175 525 875 1,225 1,575
"Normal" Payments $0 $51,625 $103,250 $103,250 $103,250 $103,250
Amortized Payments $77,437.50 $77,437.50 $77,437.50 $77,437.50 $77,437.50 $77,437.50
Training of staff will commence in January, 2007 with Program Participant
enrollment commencing February 1, 2007 with the objective of full enrollment of
350 members by May 31, 2007.
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By August 31, 2007 ALERE and ECI will reconcile the payments made during the
first six months against actual enrollment and active member months during those
six months. Any credits or debits required to settle the difference will be
applied to the September 2007 invoice (and any "carry-over" to any subsequent
invoices if necessary).
Commencing with September 2007, payment will be based on the actual number of
Program Participants members in the prior month as defined by the active Program
Participant enrollment census as of the 15th day of each month.
ECI will invoice ALERE at the end of each month based on this census and
payments will be due within five (5) business days from the date that ALERE
receives payment from Tufts Health Plan Health Plan for ECI's services.
A minimum of 300 Program Participants after September 2007 will be required. If
such number is not obtained and maintained, ECI may elect to terminate this
under section 13.2.1 of the DMSA.
6. INVOLVED TUFTS HEALTH PLAN AFFILIATES. ECI;s Care Management services will be
provided to Tufts Health Plan Health Plan's Medicare Advantage products.Tufts
Health Plan
ALERE
By: /s/
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Name:
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Title:
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ECI
By: /s/
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Name:
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Title:
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