Document:

exhibit101.htm

    
      

      

    

     

    MANUFACTURING AND SUPPLY
AGREEMENT

     

     

     

     

     

    BETWEEN

     

     

     

     

     

    FLEET
LABORATORIES

     

     

     

     

     

    AND

     

     

     

     

     

     

     

    COLUMBIA
LABORATORIES (BERMUDA), LTD.

     

    THIS MANUFACTURING AND SUPPLY
AGREEMENT (this
“Agreement”) is
made as of December 8, 2009, by and between Fleet Laboratories, a United
Kingdom company ("Fleet"),
having a place of business at 94 Rickmansworth Road, Watford Herts, WD18 7JJ,
United Kingdom and Columbia Laboratories (Bermuda), Ltd. (“Columbia”),
a Bermuda company, at Canon’s Court, 22 Victoria Street, Hamilton HM 12,
Bermuda.

     

    RECITALS

     

    A.        Columbia is engaged in,
among other things, the development, distribution and sale of drug products
including among others CRINONE® 8% (progesterone gel), PROCHIEVE® 8%
(progesterone gel), and PROCHIEVE® 4% (progesterone gel). 

     

    B.        Fleet is engaged
in the manufacture and supply of pharmaceutical formulations and bulk drug products.

     

    C.        Columbia and Fleet desire to
establish a relationship pursuant to
which Fleet will exclusively manufacture and supply, and Columbia will exclusively purchase its
requirements of, bulk progesterone gel (a “Product” as hereafter defined).

     

    In consideration of
the foregoing premises, and the mutual covenants and obligations set forth
herein, Fleet and <?xml:namespace prefix = st1 ns =
"urn:schemas-microsoft-com:office:smarttags" />Columbia hereby agree as
follows:

     

    1                   
DEFINITIONS

     

    “Adverse
Event” means any undesirable medical event that is experienced by a
legally prescribed end-user of a
finished pharmaceutical product containing a Product.  

     

    “Affiliate”
means with respect to any Person, any Person who controls, is controlled by, or
is under common control with such Person. For the purposes of this definition,
the term “control” (including, with correlative meanings, the terms
“controlling”, “controlled by” and “under common control with”) as used with
respect to any Party, shall mean the direct or indirect beneficial ownership of
more than fifty percent (50%) of the voting stock of, or more than a fifty
percent (50%) interest in the income of, such Person, or such other direct or
indirect interest or relationship as in fact constitutes actual control of a
Person.

     

    “Applicable
Law”means all applicablelaws, orders and regulations of any governmental authority with
jurisdiction over Fleet’s or Columbia’s activities in connection with this
Agreement.

     

    “Batch”
means a specific quantity of material produced in a process or series of
processes that is expected to be homogeneous within specified limits.

     

    “cGMP”
means current Good Manufacturing Practices promulgated under the United States
Federal Food and Drug Cosmetic Act and Title 21 of the Code of Federal
Regulations Part(s) 11, 210 and 211, or any analogous regulations promulgated by
any FDA-equivalent
governmental
regulatory authority in countries other than the US.

     

    “Competitive
Price” means a price for a Product that is no more than ten percent (10%)
greater than the price of the same Product available from a comparable alternate
independent third party located in North America or Europe.

     

    “Confidential
Information” means, with respect to a party, all information of any kind
whatsoever (including without limitation, data, compilations, formulae, models,
patent disclosures, procedures, processes, projections, protocols, results of
experimentation and testing, specifications, strategies and techniques), and all
tangible and intangible embodiments thereof of any kind whatsoever (including
without limitation, apparatus, compositions, documents, drawings, machinery,
patent applications, records and reports), which is disclosed by a party (the “Disclosing
Party”) to the other party (the “Receiving
Party”).  Notwithstanding the foregoing, Confidential Information of
a party shall not include information that the Receiving Party can establish by
written documentation or other competent evidence (a) to have been publicly
known prior to disclosure of such information by the Disclosing Party to the
Receiving Party, (b) to have become publicly known, without fault on the part of
the Receiving Party, subsequent to disclosure of such information by the
Disclosing Party to the Receiving Party, (c) to have been received by the
Receiving Party at any time from a source, other than the Disclosing Party,
rightfully having possession of and the right to disclose such information, (d)
to have been otherwise known by the Receiving Party prior to disclosure of such
information by the Disclosing Party to the Receiving Party, and/or (e) to have
been independently developed by employees or agents of the Receiving Party
without the use of such information disclosed by the Disclosing Party to the
Receiving Party.

     

    “Change
of Control Event” means a party is merged
or consolidated into or with another corporation or other legal person not
currently an Affiliate with such party and, as a result thereof, less than a
majority of the combined voting power of the voting securities of such party,
after such merger or consolidation is held in
the aggregate by the holders of the voting securities of such party, immediately prior to such merger or consolidation; or (b) a party sells or otherwise transfers all or substantially all of its
assets to any other corporation or other legal person not currently an Affiliate
with such party, or such party sells or otherwise transfers a majority of all of
its voting securities to any other corporation or other legal person not
currently an Affiliate with such party;

     

     “Damages”
shall have the meaning set forth in Section 10.1(a).

     

    “Debarred
Entity” shall have the meaning set forth in Section
3.3(c).

     

    “Debarred
Individual” shall have the meaning set forth in Section
3.3(c).

     

    “Defect”
or “Defective” means any instance where a Product fails to conform to the
applicable Product Specifications or fails to conform to the representations and
warranties given by Fleet herein. 

     

    “Drug
Master File” means the Drug Master File for manufacturing the Product
filed with the FDA, or its equivalent in countries other than the
US.

     

    “FDA”
means the United States Food and Drug Administration, and any successor agency
thereto, or any FDA-equivalent
governmental
regulatory authority in countries other than the US, including without
limitation the MHRA.

     

    “Force
Majeure” shall have the meaning set forth in Section 13.8.

     

    “Improvements”
means all improvements, modifications, inventions, and ideas conceived of, or
reduced to practice relating to, the Product and/or the manufacture of the
Product.

     

    “Indemnitee”
shall have the meaning set forth in Section 10.2.

     

    “Indemnitor”
shall have the meaning set forth in Section 10.2.

     

    “Initial
Term” shall have the meaning set forth in Section   12.1.

     

    “Intellectual
Property” means all of Columbia’s and its Affiliates’ Confidential
Information or proprietary information relating to trade secrets, patent rights,
technology, know-how, developments, improvements, techniques, data, methods,
processes, instructions, formulae, recipes, drawings and specifications
necessary to develop, manufacture and supply the Product and provided by
Columbia to Fleet.

     

     “MHRA”
means the United Kingdom Medicines and Healthcare products Regulatory
Agency.

     

    “Person”
means an individual, corporation, partnership, limited liability company, trust,
business trust, association, joint stock company, joint venture, pool,
syndicate, sole proprietorship, unincorporated organization, governmental
authority or any other form of entity not specifically listed
herein.

     

    “Fleet
Know-How” means any and all present and future information, any
materials, including, without limitation, formulations, processes, techniques,
formulas, biological, chemical, assay control and manufacturing data, methods,
software, equipment designs, know-how, and trade secrets, patentable or
otherwise, tangible or intangible, that are owned or controlled by
Fleet.

     

    “Fleet
Warranty” shall have the meaning defined in Section
3.3(c).

     

    “Product”
means a progesterone vaginal gel containing either 90 mg or 45 mg
progesterone w/w and polycarbophil for human use, and supplied in approved bulk
containers pursuant to the Product Specifications as they may be amended from
time to time.  

     

    “Product
Complaint” means any complaint from a Person that relates to a finished
pharmaceutical product containing the Product.

     

    “Product
Disposition” means the documented control, status and/or usage for a
Product.  Examples include, without limitation, release, rejection,
quarantine, hold, release for packaging, returns,
destruction.

     

    “Product
Quality Complaint” means any Product Complaint that may indicate a
Product quality problem.

     

    “Product
Specifications” means specifications for the Product set forth in a
 Regulatory Approval.  The Specifications shall include, without
limitation: (i) raw material specifications (including approved suppliers,
chemical, microbiological, and packaging specifications); (ii) sampling
requirements (e.g., lab, chemical, and micro); (iii) finished Product
specifications release criteria including Fleet’s Acceptable Quality Limits
(“AQL’s); (iv) stability specifications; and (v) test methods. 
Product Specifications shall be established and/or amended from time to time
upon the written agreement of both Fleet and Columbia via a Change Request
(“PCR”) in accordance with Standard Operating
Procedures.

     

    “Production
Schedule” shall have the meaning set forth in
Section 3.1(a).

     

     “Quality
Assurance” or “QA” means the group or department of either party that
performs  quality review functions.  QA reviews and approves
quality-related documents and procedures.

     

    “Quality
Control” or “QC” means the group or department of either party that
performs testing to ensure compliance to material specifications.  QC could
also perform related responsibilities including, without limitation, stability
program maintenance, sampling, and microbiology testing.

     

     “Raw
Materials” means all chemical
raw materials for a Product, including the active pharmaceutical ingredient and
excipients.

     

    “Recall
Costs” shall have the meaning defined in Section
9.2.

     

    “Recall”
shall have the meaning defined in Section 9.2.

     

    “Regulatory
Approval(s)” means any and all consents or other authorizations or
approvals required to be obtained from a governmental authority to market and
sell a finished pharmaceutical product containing a Product, but excluding any
form of pricing or reimbursement approval. 

     

    “Renewal
Term” shall have the meaning set forth in Section
12.1.

     

    “Shelf
Life and Expiration Date” means the period of acceptable use of a
finished pharmaceutical product containing the Product (when stored in
accordance with the approved labeled storage conditions).  The shelf life
shall be established using stability data generated in accordance with
Columbia’s approved stability protocol and be reflected in the Regulatory
Approvals.  

     

    “SOPs”
means Fleet’s and Columbia’s standard operating procedures applicable to
the manufacture and testing of the Product.

     

    “Term”
shall have the meaning set forth in Section 12.1.

     

     “Validation
Report” means an FDA-mandated report establishing documented evidence
which provides a high degree of assurance that a specific process will
consistently produce a product meeting its predetermined specifications and
quality attributes.  The conditions encompass upper and lower processing
limits and circumstances including those with standard operating procedures
which pose the greatest chance of process or product failure when compared to
ideal conditions.  The Validation Report will be signed by Fleet and
Columbia.

     

    2                   
MANUFACTURE
AND SUPPLY

     

    2.1             
Agreement
to Manufacture and Supply.  

     

    (a)               
Upon and
subject to the terms and conditions of this Agreement, Fleet agrees to
manufacture Product exclusively for Columbia and supply Columbia such
requirements of the Product for marketing, sale, distribution and use, as
Columbia may order from time to time, and Columbia agrees to purchase
requirements of the Product exclusively from Fleet, provided Fleet supplies
Product at a Competitive Price.  Columbia agrees and covenants not to transfer any Fleet Know-How or
Confidential Information to any alternate supplier and hereby acknowledges that
any such transfer of Fleet Know-How or Confidential Information will
competitively harm Fleet.  

     

    (b)              
Columbia
hereby grants to Fleet a non-exclusive, royalty-free license to use and practice
the Intellectual Property solely and exclusively in connection with the
manufacture and supply of Product to Columbia, as Columbia may order from time
to time, in accordance with the provisions of this Agreement. Fleet acknowledges
that it has no ownership or other rights in Columbia’s Intellectual Property
and/or the Product.  Fleet
hereby grants to Columbia all right, title and interest to all Improvements
conceived of, or reduced to practice by, Fleet, its Affiliates or third parties
under contract with Fleet and, in connection therewith, shall (i) promptly
disclose the same to Columbia, and (ii) take all acts, at Columbia’s sole cost
and expense, as may be reasonably requested by Columbia to transfer or instill
ownership of the same in Columbia; provided however, the rights of the parties
with respect to any Improvements and the terms and conditions under which such
Improvements shall be developed, including without limitation rights to
financial compensation for any work performed by Fleet outside the scope of this
Agreement shall be subject to the reasonable agreement of Columbia and Fleet. In
addition, to the extent any Improvements have application to both the Product
and to other products or processes owned, developed or utilized by Fleet, such
Improvements shall be the property of Fleet and Fleet shall grant to Columbia a
perpetual, exclusive, royalty-free license to
use such Improvements in connection with the Product and any Improvements
thereto.  

     

    (c)                Fleet
shall use its commercially reasonable efforts to, at
its sole cost and expense, obtain all necessary authorizations under Applicable
Law to manufacture the Product at the site at which the manufacture of Product
shall occur and provide Columbia with a copy of any authorizations or
applications filed therefor.  During the term of this Agreement, Fleet
shall not, without the prior written consent of Columbia which shall not be
unreasonably withheld or delayed, assign
or transfer any authorizations obtained in connection with the manufacture of
the Product or applications filed therefor. Fleet shall provide Columbia with
reasonable advance notice of all meetings or calls with any governmental
authorities relating to the manufacture of the Product.  Columbia may
attend such meetings or calls, at its own cost and expense.

     

    2.2             
Regulatory
Requirements.

     

    (a)               
Annual
Reports and Post-Approval Supplements.

     

    (i)                
Columbia or
its designee shall be, at its sole cost and expense, responsible for the filing
and maintenance of any Regulatory Approvals and/or to supplement such Regulatory
Approvals; provided, however, that Fleet shall, at Fleet’s sole cost and
expense, take all steps necessary to obtain any authorizations under Applicable
Law necessary to manufacture the Product at the site at which the manufacture of
Product shall occur.  Columbia or its designee shall be responsible for
completing such submissions of Regulatory Approvals and for payment of
associated fees and Columbia shall be responsible for its pro rata share of any
fee assessed on Fleet’s facility by the FDA or other governmental authority with
respect to any Regulatory Approval, including, without limitation, prescription
drug-user fees.

     

    (ii)              
Subject to
Columbia’s confidentiality obligations set forth in Section 11, Fleet shall (A)
communicate and deliver to Columbia, for Columbia’s sole use, all information
presently in possession of Fleet, or that may hereafter come into the possession
of Fleet, that is reasonably necessary for the registration and maintenance of
Regulatory Approvals; (B) provide reasonable technical assistance, as may
be reasonably requested by Columbia from time to time, including without
limitation relating to test methods, specifications, and impurity/degradation
product identification, and (C) execute and/or deliver such documents, reports
and certificates and take such other action, as Columbia may reasonably request,
to assist Columbia to procure the amendment to any Regulatory Approvals. 
If additional development or validation work is required or requested by
Columbia subsequent to receiving any Regulatory Approval, the terms under which
such additional development or validation work shall be performed will be
mutually agreed upon by both Fleet and Columbia.  

     

    2.3             
Quality
Requirements and Manufacturing Practices.

     

    (a)               
Validation.
Fleet is responsible for providing Columbia with a validation package that is in
accordance with the requirements of Applicable Law, including, without
limitation, those relating to cGMP, and including, without limitation (1) the
validation protocol for process, method, and cleaning validation, (2) full document packages, (3) all validation
data and (4) a Validation Report.  Columbia must approve the validation
protocol and Validation Report, which approval shall not be unreasonably
withheld. Fleet and Columbia will agree in writing on the activities and
associated costs. 

     

    (b)              
Product
Specifications. Fleet shall manufacture and warehouse the Product in
conformity with the Product Specifications and in accordance with the
requirements of Applicable Law,
including, without limitation, those relating to cGMP.

     

    (c)               
Raw
Materials. Fleet shall order those Raw Materials  that Columbia does
not supply from vendors as required to support Fleet’s obligations under this
Agreement.  Fleet shall maintain sufficient stocks of Raw Materials to meet
its manufacturing and supply obligations to, and as scheduled by, Columbia;
provided, however, that Fleet shall have a retest date in accordance with its
SOPs (which Fleet shall provide to Columbia upon request) for Raw Materials. Raw
Materials shall not be used beyond their expiration date as provided by the Raw
Material supplier without the written consent of Columbia. 

     

    (i)                
Testing and
retesting costs of Raw
Materials shall be included in the sales price.  Fleet shall be responsible
for all Raw Material costs, freight, insurance charges, taxes, import and export
duties, inspection fees and other charges applicable to the sale and transport
of Raw Materials hereunder which Fleet
supplies.  Fleet
shall not use any Raw Materials purchased directly by Columbia except for the
manufacture of Product hereunder.  Columbia will be responsible for all
retesting costs associated with the Raw Materials  supplied by
Columbia.

     

    (ii)              
Fleet shall
notify Columbia of any Raw Materials that do not meet Raw Material
specifications, and shall provide Columbia full details within 24 hours of
completion of the investigation, but not more than twenty (20) business days
from identification of the out of specification result. 

     

    (d)              
In-Process
Testing. Fleet is responsible for ensuring, and shall ensure, that all
required in-process testing of Product is carried out and documented, and is in
accordance with the requirements of Applicable Law, including, without
limitation, those relating to cGMP.

     

    (e)               
Product
Testing. Columbia is responsible for ensuring finished Product testing is
performed on all Batches. All such testing shall be in accordance with Product
Specifications and in accordance with the requirements of Applicable Law,
including, without limitation, those relating to cGMP. 

     

    (f)               
Stability
Testing. Columbia is responsible for ensuring performance of stability
testing of finished pharmaceutical products containing a Product.  

     

    (g)              
Retained
Samples. Fleet will be responsible for, and retain and store both Raw
Material and final Product samples in accordance with SOPs and in accordance
with Applicable Law, including, without limitation, those relating to
cGMP.  Columbia may require that a duplicate set of Product samples be
supplied to Columbia for retention and storage.  Such duplicate set of
Product samples shall be supplied promptly. 

     

    (h)              
Product
Disposition. The Columbia Qualified Person (“QP”)  is responsible
for, and shall conduct, the final disposition of all Product lots for commercial
use according to Columbia’s procedures.  For each Product lot, Fleet is
responsible for providing, and shall provide, Columbia QA with 1) a full
production documentation package and 2) a copy of any deviations and
investigations.  

     

    (i)                
Change
Control. Fleet will not undertake any changes to the manufacturing
process, including, without limitation, equipment, critical facilities
utilities, methods, and cleaning procedures (together, “Product
Changes”), without Columbia’s prior written authorization.  Columbia
will not unreasonably withhold its consent to any requested Product Changes,
provided, that such Product Changes would not affect Columbia’s Regulatory
Approvals under current regulatory guidelines nor adversely affect Fleet’s
ability to timely deliver Product in connection with this Agreement. 
Columbia will notify Fleet, in writing and in advance, of any Product Changes to
ensure that Fleet is capable of making the change.  Fleet shall comply with
any reasonable request by Columbia for changes in the Product Specifications,
manufacturing process and materials, and any change in analytical testing
methods requested by Columbia, the FDA or any other applicable regulatory
agency.  Any Product Changes (and work to be performed subsequent to such
Product Change that is outside the scope of this Agreement) shall be governed by
and subject to the reasonable agreement of Columbia and
Fleet.

     

    (j)                
Rework.
Rework of
Product is not permitted without the prior written consent of
Columbia.

     

    (k)              
Reprocessing.  
Reprocessing of Product or of work-in-progress is not permitted without the
prior written consent of Columbia.

     

    (l)                
Obsolete
Inventory.   Any Columbia specific inventory including, but not
limited to, raw materials and work-in-process rendered obsolete as a result of
formula, artwork, packaging changes or Product Changes requested by Columbia or
by changes required by a Regulatory  Approval shall be reimbursed to Fleet
by Columbia at Fleet’s standard cost.  Any Columbia specific inventory
including, but not limited to, raw materials and work-in-process rendered
obsolete as a result of an act, or failure to act, of Fleet or Product Changes
requested by Fleet shall be at the sole expense of Fleet. Fleet shall be
responsible for the disposition of the obsolete inventory, and the party
responsible for the obsolescence (either Columbia or Fleet, as the case may be)
shall bear one hundred percent (100%) of all destruction costs related to said
obsolete inventory.  The destruction or disposition shall be in accordance
with Applicable Law.  Fleet shall provide Columbia with all manifests and
other applicable evidence of proper destruction of materials purchased by or on
the account of Columbia or required by Applicable Law.

     

    (m)            
Nonconforming
Batches.  Fleet will pay for all disposal costs related to
nonconforming Batches.

     

    3                   
PRODUCTION
SCHEDULES AND ORDERS

     

    3.1             
Production
Schedules. 

     

    (a)               
Production
Schedule.  Each month during the Term Columbia shall prepare and provide Fleet with
a written Production Schedule of its requirements for Product (each, a “Production
Schedule”). The amounts set forth for the first three full months in each
Production Schedule shall constitute a firm purchase order and shall be binding
upon Columbia(each
a “Purchase
Order”).  The amounts
set forth in the following months shall constitute Columbia’s non-binding, good
faith estimate of the Product requirements of Columbia for such
periods.

     

    (b)              
Supply
Obligation.  Fleet shall manufacture, supply and deliver to Columbia
all quantities of Product as Columbia orders pursuant to Section 3.1(d)
below.

     

    (c)               
Columbia
agrees to purchase from Fleet all Product manufactured for Columbia by Fleet in
accordance with Columbia’s Purchase Orders so long as such Products meet the
Specifications or exceptions approved by Columbia.

     

    (d)              
Orders. 
Each Purchase Order shall specify
in writing the description of the Product ordered, the quantity ordered, the
price therefor, delivery in accordance with Section 3.3 below, and the required
delivery date.  In the event of a conflict between the terms and conditions
of any Purchase
Order and this
Agreement, the terms and conditions of this Agreement shall
prevail. 

     

    3.2             
Reports by
Fleet.
Fleet shall provide to Columbia a monthly report setting forth the inventory of
Columbia purchased Raw Materials in its possession and used in its production of
Product during such period. Such reports shall be received by Columbia not later
than the fifth (5th) business day after the close of every calendar
month.

     

    3.3             
Delivery
and Acceptance.

     

    (a)               
Delivery. 
All Product supplied under this Agreement shall be delivered EXW Fleet’s
Watford, UK facility.   Title and risk of loss shall pass to Columbia
upon receipt of the Product at Fleet’s facility by the carrier
designated by Columbia.  The
weights, tariffs and tests affixed by Fleet’s invoice shall govern unless
established to be incorrect.  Claims relating to quantity, weight and loss
or damage to any Product sold under this Agreement shall be waived by Columbia
unless made within ninety (90) days of receipt of Product by
Columbia.

     

    (b)              
Rejection
and Cure.   If a shipment of Product or any portion thereof
contains a Defect, Columbia shall have the right to reject such Defective
shipment of Product or the portion thereof, upon written notice to Fleet of its
rejection hereunder, to be given within thirty (30) days after Columbia’s
discovery of such Defect, specifying the grounds for such rejection.  After
receipt of such notice from Columbia, Fleet shall be permitted to analyze any
Product rejected by Columbia regarding such Defect, at Fleet’s sole cost and
expense, and to present its findings with respect to such Product to
Columbia.  If the parties cannot agree on whether the Product in question
contains a Defect, an independent FDA and/or MHRA qualified laboratory,
reasonably acceptable to both parties and at a cost equally shared by both
parties, shall analyze both Columbia’s and Fleet’s samples of Product in
question, and the definitive results of such laboratory shall be binding. 
If the shipment of Product in question is determined to contain a Defect, such
Product shall be held for Product Disposition, or shall be returned to Fleet, in
each case at Fleet’s expense, as directed by Columbia.  Fleet shall replace
each Defective shipment of Product, or the portion thereof, with conforming
Product within thirty (30) days of the later of receipt of notice of rejection
or expedited receipt of out of stock raw materials, if any.

     

     Fleet shall
bear one hundred percent (100%) of all costs including cost of destruction of
all rejected Product resulting from the fault or negligence of Fleet. Columbia
shall bear one hundred percent (100%) of all costs including cost of destruction
of all rejected Product resulting from the fault or negligence of
Columbia.   Fleet shall destroy rejected Product in accordance with
all Applicable Laws, and shall indemnify Columbia for any liability, costs or
expenses, including attorney’s fees and court costs, relating to a failure to
dispose of such Product in accordance with Applicable Law, and shall provide all
manifests and other applicable evidence of proper destruction as may be required
by Applicable Law.

     

    (c)               
Fleet
Warranty. 
Fleet warrants that (i) Product manufactured hereunder shall conform to the
Product Specifications; (ii) Product is manufactured in compliance with
Applicable Law,
including, without limitation, cGMPs; and (iii) Fleet does not (A) employ an
individual who has been debarred by the FDA pursuant to 21 U.S.C. § 335a(a) or
(b) (“Debarred
Individual”) to provide services in any capacity to a Person that has an
approved or pending drug product application, or an employer, employee or
partner of such a Debarred Individual or, (B) utilize a corporation, partnership
or association that has been debarred by FDA pursuant to 21 U.S.C. § 335a(a) or
21 U.S.C. § 335a(b) (“Debarred
Entity”) from submitting or assisting in the submission of a drug
application, or an employee, partner, shareholder, member, subsidiary, or
Affiliate of a Debarred Entity, and (C) to the knowledge of Fleet, no
circumstances exist that may affect the accuracy of the foregoing
representations contained in clauses (iii)(A) and (B) of this Section
3.3(c), including, without limitation, any FDA investigations of, or debarment
proceedings against, Fleet or any person or entity performing services or
rendering assistance which is in any way related to activities taken pursuant to
this Agreement, and shall immediately notify Columbia in writing if Fleet, at
any time during the Term, becomes aware of any such circumstances.  The
foregoing shall comprise the “Fleet
Warranty”. 

     

    4                   
AUDIT AND
INSPECTION

     

    4.1             
Audits. 
Columbia QA may conduct inspections and audits of Fleet’s manufacturing
facility, quality control laboratories, and other quality systems relating to
the manufacture and storage of the Product according to Columbia’s reasonable
procedures upon reasonable prior written notice, during normal business hours,
at its sole cost and expense; provided, however, that Columbia may conduct a
“For Cause” audit, during normal business hours, at Columbia’s sole cost and
expense, upon three (3) business days prior written notice to Fleet. 
Columbia shall have the right, in connection with any such audit, to inspect and
obtain copies of any records or other documents and materials associated with or
related to the manufacture of the Product. Fleet shall promptly notify Columbia
of any proposed inspections by any governmental authority of the facilities at
which Product is manufactured in sufficient time for Columbia to attend such
inspection.

     

    Columbia agrees to
provide Fleet with copies of any part of a Regulatory Approval applicable to the
Product manufactured and/or tested by Fleet, and copies of any changes in or
updates of same as they, from time to time, hereafter occur.

     

    4.2             
Person in the
Plant; Manufacturing Operations.
Columbia may, at its option and sole cost and expense, upon reasonable prior
written notice, have up to three (3) people on site during normal business
hours, to observe the manufacturing and storage activities of Fleet.  These
individuals may observe such activities and provide technical or quality
advice.  Columbia QA will be consulted concerning any quality-related
incidents that occur during manufacture.  Fleet is responsible for
documenting any event (i.e. deviation) from Fleet SOPs that may occur during
manufacture of the Product.  Columbia QA retains the final authority
regarding any action taken during manufacture of the Product that may affect the
Product quality.  Fleet QA is responsible for ensuring and shall ensure
that the Product is manufactured in accordance with Regulatory Approvals and in
accordance with Applicable Law, including without limitation, those relating to
cGMP. 
Columbia acknowledges
and agrees that its representatives visiting any Fleet facility may, at Fleet’s
discretion, be subject to reasonable and necessary confidentiality procedures to
secure other Fleet clients’ information. 

     

    5                   
PRICE AND PAYMENT
TERMS

     

    5.1
      Price. 
During the Term,
the purchase price for each Batch purchased by Columbia from Fleet shall be the
price stated on Exhibit A attached hereto. This price may be adjusted annually
on the anniversary date of the execution of this Agreement to take into account
any documented decrease or increase in the cost of Raw Materials or any other
decrease or increase in the cost of manufacturing the Product.  If Columbia
finds an alternate supplier that reduces the raw material cost and Fleet secures
such alternate supplier,
or Columbia identifies any other decrease in the cost of manufacturing, the
price per Batch shall be reduced by 50% of the amount of the reduction in cost
identified.  If Fleet finds an alternate supplier that reduces the raw
material cost, or identifies any other decrease in the cost of manufacturing,
the price per Batch shall be adjusted to reflect one-half the reduction,
provided that the cost of qualifying and obtaining any Regulatory Approval is
borne 50:50 by both parties. Upon reasonable prior written notice from Columbia,
Fleet shall provide Columbia with all books and records necessary to verify
changes to the Product manufacturing costs. 

     

    5.2             
Invoicing. 
Upon delivery of Product to Columbia, Fleet shall submit invoices therefor to
Columbia.  Columbia shall pay each invoice in full within thirty (30) days after the
date of receipt by Columbia of such invoice, which shall be issued no earlier
than the date on which the Product is delivered to the carrier by Fleet. 
All payments shall be made in pounds sterling.  

     

    6                   
FACILITY
QUALIFICATION  

     

    6.1             
Fleet shall,
promptly, take all actions to qualify (and thereafter to maintain qualification
of) the facility or facilities at which Fleet manufactures the Product
hereunder, as required under Applicable Law,
including, without limitation, cGMPs.  For the avoidance of doubt, such
qualification shall include, without limitation, (a) completion of validation by
Fleet of the Product and all processes in connection with the manufacture
thereof and (b) such other consents or Regulatory Approvals necessary for the
manufacture and sale of the Product   

     

    7                   
REPRESENTATIONS AND WARRANTIES

     

    7.1             
Each party
hereby represents and warrants to the other party as
follows:

     

    (a)               
Corporate
Existence. 
Such party is a corporation or other entity duly organized, validly existing and
in good standing under the laws of the jurisdiction in which it is
incorporated.

     

    (b)              
Authorization
and Enforcement of Obligations.  Such party (i) has the corporate
power and authority and the legal right to enter into this Agreement and to
perform its obligations hereunder, and (ii) has taken all necessary corporate
action on its part to authorize the execution and delivery of this Agreement and
the performance of its obligations hereunder.  This Agreement has been duly
executed and delivered on behalf of such party, and constitutes a legal, valid
and binding obligation, enforceable against such party in accordance with its
terms.

     

    (c)               
Consents. 
All necessary consents, approvals and authorizations of all governmental
authorities and other Persons required to be obtained by such party in
connection with its performance of this Agreement have been
obtained.

     

    (d)              
No
Conflict.  The execution and delivery of this Agreement and the
performance of such party’s obligations hereunder (i) do not conflict with or
violate any requirement of Applicable Law, and (ii) do not conflict with, or
constitute a default under, any material contractual obligation of such
party.  

     

    8                   
INSURANCE

     

    Fleet and Columbia
shall maintain comprehensive general liability insurance, including product
liability insurance against claims regarding the manufacture of Product under
this Agreement, with insurers having an AM Best rating within the top 2
categories at the time (at the date of this Agreement known as “superior” or
“excellent”) or reasonably comparable coverage, in such amounts as it
customarily maintains for similar products and activities, but in no event less
than $3,000,000 per individual claim and $3,000,000 in the aggregate.  Each
party shall maintain such insurance during the Term and thereafter for so long
as it customarily maintains insurance for itself for similar products and
activities (but in no event less than two (2) years following termination or
expiration).  Each party shall cause the other party to be named as an
additional insured under such insurance and shall provide the other party proof
of such insurance upon request.  Each party shall cause such insurance
policies to provide that the other party shall be given at least thirty (30)
days notice of any cancellation, termination or change in such insurance. 
Either party may elect to substitute a self-insurance program on notice to the
other party with information reasonably demonstrating the adequacy of such
program.

     

    9                   
ADVERSE
EVENTS; RECALL.

     

    9.1             
Product
Complaints and Adverse Events. Columbia and Fleet shall each notify the
other within twenty four (24) hours of any Product Complaints or any serious and
unexpected Adverse Events reported to Columbia or Fleet resulting from the use
of a finished pharmaceutical product containing a Product.  Both Columbia
and Fleet agree to furnish each other with any information pertaining to the
event in a timely manner.  Columbia QA will initiate an investigation of
each Product Complaint according to Columbia procedures and promptly notify
Fleet QA of any specific reasonable actions that need to be taken by
Fleet.  Columbia shall have the sole right to respond to all Product
Complaints and for reporting any unexpected Adverse Events to the relevant
regulatory authorities resulting from use of a finished pharmaceutical product
containing a Product in accordance with Applicable Law.  Fleet agrees to
cooperate with Columbia in connection with any such response or report, at
Columbia’s expense.  

     

    9.2             
Recalls. 
In the event either party believes it may be necessary to conduct a recall,
field correction, market withdrawal, stock recovery, or other similar action
with respect to any finished pharmaceutical product containing a Product that
was sold by Fleet or its Affiliates to Columbia or its Affiliates under this
Agreement (a “Recall”),
Fleet and Columbia shall consult with each other as to how best to proceed, it
being understood and agreed that the final decision as to any Recall of any
finished pharmaceutical product containing a Product shall be made by Columbia;
provided, however, that Fleet shall not be prohibited hereunder from taking any
action that it is required to take by Applicable Law.  Columbia and Fleet
shall work together to agree on the details of any Recall decision; however
Columbia is responsible for executing a Recall of Columbia distributed finished
pharmaceutical product containing a Product.  Fleet QA is responsible for
notifying Columbia QA of all quarantined Product in Fleet’s possession. If a
Recall arises from the manufacture of the Product or Fleet’s breach of its
representations, warranties  (including, without limitation, the Fleet
Warranty), covenants or obligations hereunder, the cost of goods sold,
distribution expenses and all other recall expenses (collectively, the “Recall
Costs”) shall be borne by Fleet.  If a Recall arises from Columbia’s
marketing, distribution, storage or handling of a finished pharmaceutical
product containing a Product, Recall Costs shall be borne by Columbia. 
Columbia and Fleet shall each maintain records of all sales of Product and
finished pharmaceutical product containing a Product sufficient to adequately
administer a Recall for the period required by Applicable
Law. 

     

    10               
INDEMNIFICATION; LIMITATIONS OF LIABILITY

     

    10.1          Indemnification.

     

    (a)               
Fleet’s
Indemnity Obligations.  Fleet shall defend, indemnify and hold
harmless Columbia, its Affiliates and their respective successors and permitted
assigns (and the respective officers, directors, stockholders, partners and
employees of each) from and against any and all losses, liabilities, claims,
actions, proceedings, damages and expenses (including, without limitation,
reasonable attorneys’ fees and expenses) (“Damages”)
relating to or arising from (i) any breach by Fleet or its Affiliates of its
representations, warranties, covenants, agreements or obligations under this
Agreement, including without limitation, the failure of Fleet to timely deliver
all Product ordered or the failure of the Product to meet the Fleet Warranty
and/or Product Specifications and (ii) any claims of infringement or
misappropriation with respect to the manufacture of the Product, except to the
extent such claim of infringement  relates to the use of the Intellectual
Property.

     

    (b)              
Columbia’s
Indemnity Obligations.  Columbia shall defend, indemnify and hold
harmless Fleet and its Affiliates, and their respective successors and permitted
assigns (and the respective officers, directors, stockholders, partners and
employees of each) from and against any and all Damages arising out of (i) the
handling, possession, use, marketing, distribution or sale of any Product and
finished pharmaceutical product containing a Product by Columbia or any of its
distributors or agents after Fleet’s delivery of the Product to Columbia; (ii)
product liability claims, including, wrongful death, resulting from the use of
the a finished pharmaceutical product containing a Product (except to the extent
such claims arise out of the circumstances described in Section 10.1(a);
(iii)  any breach by Columbia of its representations, warranties,
covenants, agreements or obligations under this Agreement; and (iv) any claims
of infringement or misappropriation relating to the Intellectual
Property.

     

    10.2          Indemnification
Procedure.  A party (the “Indemnitee”)
that intends to claim indemnification under this Section 10 shall notify the
other party (the “Indemnitor”)
promptly in writing of any action, claim or liability in respect of which the
Indemnitee believes it is entitled to claim indemnification, provided that the
failure to give timely notice to the Indemnitor shall not release the Indemnitor
from any liability to the Indemnitee except to the extent the Indemnitor is
prejudiced thereby.  The Indemnitor shall have the right, by notice to the
Indemnitee, to assume the defense of any such action or claim within a
reasonable period after the Indemnitor’s receipt of notice of any action or
claim with counsel of the Indemnitor’s choice and at the sole cost of the
Indemnitor.  If the Indemnitor so assumes such defense, the Indemnitee may
participate therein through counsel of its choice, but at the sole cost of the
Indemnitee.  The party not assuming the defense of any such claim shall
render all reasonable assistance to the party assuming such defense, and all
reasonable out‐of‐pocket costs of such assistance shall be for the account of
the Indemnitor.  No such claim shall be settled other than by the party
defending the same, and then only with the consent of the other party which
shall not be unreasonably withheld; provided that the Indemnitee shall have no
obligation to consent to any settlement of any such action or claim which
imposes on the Indemnitee any liability or obligation which cannot be assumed
and performed in full by the Indemnitor, and the Indemnitee shall have no right
to withhold its consent to any settlement of any such action or claim if the
settlement involves only the payment of money by the Indemnitor or its
insurer.

     

    10.3          Limitations
of Liability. 
Notwithstanding any contrary provision herein no party shall be entitled to
indemnification with respect to any claim or suit to the extent such claim or
suit results from (i) its own negligence or willful misconduct, or (ii) breach
of such party’s representations, warranties, covenants, agreements or
obligations under this Agreement, or (iii) any action to which it has consented
in writing. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY PUNITIVE,
CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES, INCLUDING DAMAGES FOR LOST
PROFITS, LOSS OF OPPORTUNITY OR USE OF ANY KIND, SUFFERED BY THE OTHER PARTY,
WHETHER IN CONTRACT, TORT OR OTHERWISE, AND REGARDLESS OF WHETHER SUCH PARTY WAS
ADVISED OF, KNEW OF OR SHOULD HAVE KNOWN ABOUT THE POSSIBILITY OF SUCH
LOSS.

     

    11               
CONFIDENTIALITY AND PUBLIC DISCLOSURE

     

    11.1          Confidentiality. 
Except for literature and information intended for disclosure to customers, each
party will treat as confidential the Confidential Information, and will take all
necessary precautions to assure the confidentiality of such Confidential
Information.  Each party agrees to return to the other party upon the
expiration or termination of this Agreement all Confidential Information
acquired from such other party, except as to such information it may be required
to retain under Applicable Law, and except for one copy of such information to
be retained by such party’s legal counsel.  Neither party shall, during the
period of this Agreement nor for five (5) years thereafter, without the other
party’s express prior written consent use or disclose any such Confidential
Information for any purpose other than to carry out its obligations
hereunder.  Each party, prior to disclosure of such Confidential
Information to any employee, consultant or advisor shall ensure that such person
is bound in writing to observe the confidentiality provisions at least as strict
as those of this Agreement.  The obligations of confidentiality shall not
apply to information that the Receiving Party is required by Applicable Law to
disclose, provided however that the Receiving Party shall so notify the
Disclosing Party of its intent and cooperate with the Disclosing Party on
reasonable measures to protect the confidentiality of the
information.

     

    11.2          Required
Disclosures. If either Columbia or Fleet is required by Applicable Law
to disclose all or any
part of any Confidential Information disclosed to it by the other party, it will
(i) immediately notify the other party hereto of the existence, terms and
circumstances surrounding such a request, (ii) consult with the other party
on the advisability of taking legally available steps to resist or narrow such
request, and (iii) exercise its commercially reasonable efforts to obtain an
order or other reliable assurance that confidential treatment will be accorded
to such portion of the Confidential Information required to be disclosed.

     

    11.3          Public
Announcements.   Except for such disclosure as is deemed
necessary, in the reasonable judgment of a party, to comply with Applicable Law,
no announcement, news release, public statement, publication, or presentation
relating to the existence of this Agreement, the subject matter hereof, or
either party’s performance hereunder will be made without the other party’s
prior written approval.  

     

    12               
TERM AND
TERMINATION

     

    12.1          Term. 
Unless terminated earlier pursuant to Section 12.2 below, the initial term
of this Agreement shall expire on the date which is five (5) years from the date
of the execution of this agreement (“Initial
Term”) and shall be automatically extended for additional periods of two
(2) years (each a “Renewal
Term”) and together with the Initial Term, the “Term”,
unless either party gives to the other party, not less than six (6) months 
prior to expiration of the Initial Term or any Renewal Term, written notice of
its intention not to extend this Agreement; provided, however, that upon
termination of this Agreement Fleet agrees to perform its obligations under this
Agreement for the earlier of one year or Columbia’s engagement and qualification
of an alternative manufacturer of the Product.

     

    12.2          Termination. 

     

    (a)               
Either party
shall have the right to terminate this Agreement immediately, upon or
after:

     

        (i)                
the breach of
any material provision of this Agreement by the other party if the other party
has not cured such breach within sixty (60) days after receipt of written notice
thereof from the non‐breaching party;

     

        (ii)              
in the event
that the other party is or becomes insolvent, files or has filed against it a
petition in bankruptcy (provided that in the case of such petition being filed
against it, such petition is not dismissed within thirty (30) days from the date
of such petition), makes any assignment for the benefit of creditors, has
appointed a receiver of its property or a substantial portion thereof, or takes
advantage of any other law or procedure for the protection of creditors,
including, proceedings under United States bankruptcy
laws.

     

    (b)              
Columbia
shall have the right to terminate this Agreement upon thirty (30) days notice to
Fleet in the event:

     

        (i)   Fleet fails to
maintain its authorizations under Applicable Law to manufacture the Product,
including without limitation those from FDA and MHRA; 

     

        (ii)   a Change of Control Event with respect to Fleet
occurs, or 

     

        (iii)        Fleet cannot supply
product at a Competitive Price.

     

    (c)               
Fleet shall
have the right to terminate this Agreement upon six (6) months notice to
Columbia in the event that Columbia purchases less than £70,000 of Product over
the immediately preceding 12 calendar months. 

     

    (d)              
Expiration or
termination of this Agreement shall be without prejudice to any rights of either
party against the other that may have accrued prior to the date of such
termination.

     

    12.3          Effect
of Expiration and Termination. 

     

    (a)               
Upon the
expiration or earlier termination of this Agreement, each party shall immediately deliver to the other (and cause each of
its employees, agents or representatives to so deliver), at such party’s
expense, all Confidential Information of the other party, including without
limitation any and all copies, duplications, summaries and/or notes thereof or
derived there from, regardless of the format.  

     

    (b)              
Expiration or
termination of this Agreement shall not relieve the parties of any obligation
accruing prior to such expiration or termination.  The provisions of
Sections 1 (Definitions), 7 (Representations and Warranties), 8 (Insurance), 9
(Adverse Events; Recalls), 10 (Indemnification; Limitation of Liability), 11.1
(Confidentiality and Public Disclosure), 12 (Term and Termination), and 13
(General Provisions) shall survive any expiration or termination of this
Agreement.

     

    (c)               
If Columbia
terminates this Agreement under Section 12.2 (b)(ii) or (iii), it shall
reimburse Fleet for the cost of Fleet’s inventory of raw materials that are
unique to the Products   

     

    13               
GENERAL
PROVISIONS

     

    13.1          Notices. 
All notices or other communications given pursuant hereto by one party hereto to
the other party shall be in writing and deemed given (a) when delivered by
messenger, (b) when sent by telecopy (with receipt confirmed), (c) when received
by the addressee, if sent by Express Mail, Federal Express or other express
delivery service (receipt requested), or (d) five (5) days after being mailed in
the U.S., first-class postage prepaid, registered or certified, in each case to
the appropriate addresses and telecopier numbers set forth below (or to such
other addresses and telecopier numbers as a party may designate as to itself by
notice to the other party):

     

    If to Fleet:

    Fleet
Laboratories Limited 

    94
Rickmansworth Road  

    Watford
Herts

    WD18
7JJ, UK

    Tel:
01923 229251

    Fax:
01923 220728 

    Attention: Managing
Director                                                           
                       
                     

     

     

     

    If to
Columbia:

    Columbia
Laboratories (Bermuda), Ltd.

    Canon’s
Court

    22
Victoria Street

    P O Box
HM 1179

    Hamilton
HM EX

    Bermuda

    TEL: 441
298 3529

    FAX: 441
298 3467

    Attention:
President

     

     

    With Copy to:

    Columbia
Laboratories, Inc.

    354
Eisenhower Parkway

    Livingston, New Jersey 07039

    Tel:      973-994-3999

    Fax:     973-994-3001

    Attention: General Counsel

     

     

     

    13.2          Assignment. 
Neither party shall, without the prior written consent (not to be unreasonably
withheld or delayed) of the other party having been obtained, assign or transfer
this Agreement to any person or entity, in whole or in part (and any attempt to
do so shall be void), provided that, each party may assign or transfer this
Agreement to any Affiliate or to any successor by merger of such party, or upon
a sale of all or substantially all of such party’s assets, provided that such
assigning party shall remain liable for its obligations hereunder. 
Notwithstanding the foregoing, Columbia shall not be required to consent, and it
shall not be deemed unreasonable for Columbia to withhold consent, to any
proposed or attempted assignment (including by merger or sale) by Fleet to a
party which is not an Affiliate, if Columbia is not reasonably satisfied that
the assignee possesses the management, finances, personnel, capabilities and
facilities to perform fully the obligations of Fleet hereunder.  All of the
terms and provisions of this Agreement shall be binding upon and inure to the
benefit of and be enforceable by the parties hereto and their respective
successors and permitted assigns.

     

    13.3          Independent
Contractor.  The relationship between Fleet and Columbia is solely
that of buyer and seller, it being understood that each party is acting as an
independent contractor for its own account and this Agreement does not establish
a joint venture, agency, partnership or employer/employee relationship between
the parties.  Neither party shall have authority to conclude contracts or
otherwise to act for or bind the other party in any manner, whatsoever, as agent
or otherwise.  Any and all contracts and agreements entered into by either
party shall be for that party’s sole account and risk and shall not bind the
other party in any respect.

     

    13.4          Severability. 
If any portion of this Agreement is held invalid by a court of competent
jurisdiction, such portion shall be deemed to be of no force and effect and the
Agreement shall be construed as if such portion had not been included herein,
provided however, if the deletion of such provision materially impairs the
commercial value of this Agreement to either party, the parties shall attempt to
renegotiate such provision in good faith.

     

    13.5          Entire
Agreement.  This Agreement and all Exhibits attached hereto contain
the sole and entire agreement and understanding of the parties hereto and their
respective Affiliates and representatives related to the subject matter hereof
and supersede all oral or written agreements concerning the subject matter made
prior to the date of this Agreement.  

     

    13.6          Amendment;
Waiver.  This Agreement cannot be amended, changed, modified or
supplemented orally, and no amendment, change, modification or supplement of
this Agreement shall be recognized nor have any effect, unless the writing in
which it is set forth is signed by Fleet and Columbia, nor shall any waiver of
any of the provisions of this Agreement be effective unless in writing and
signed by the party to be charged therewith.  The failure of either party
to enforce, at any time, or for any period of time, any provision hereof or the
failure of either party to exercise any option herein shall not be construed as
a waiver of such provision or option and shall in no way affect that party’s
right to enforce such provision or exercise such option.  No waiver of any
provision hereof shall be deemed to be, or shall constitute, a waiver of any
other provision, or with respect to any succeeding breach of the same
provision.

     

    13.7          Governing
Law, Dispute Resolution. 

     

    (a)               
This
Agreement shall be governed by, and construed in accordance with, the laws of
England.  The parties agree to resolve any dispute solely and exclusively
in the English courts.

     

    13.8          Force
Majeure.  

     

    (a)               
The
obligations of either party hereunder, other than payment obligations, shall be
suspended during the time and to the extent that such party is prevented from
performing under this Agreement due to any event or circumstances beyond the
control and without the fault or negligence of such non-performing party (which
circumstance is hereinafter referred to as “Force
Majeure”).

     

    (b)              
As soon as
possible after being affected by a Force Majeure circumstance, the party so
affected shall furnish to the other party all particulars of the Force Majeure
and the manner in which its performance is thereby prevented or delayed. The
party whose obligations hereunder have been suspended shall promptly and
diligently pursue appropriate action to enable it to lift the Force Majeure
situation, except that a party shall not be obligated to settle any strike,
lockout or other labor difficulty on terms contrary to its
wishes.

     

    (c)               
In the event
that a party prevented from performing due to a Force Majeure circumstance
cannot remove or overcome such circumstance within ninety (90) days from the
date first prevented from performing, the other party may, at the expiration of
such period by notice to the non-performing party, terminate the Term of this
Agreement and neither Fleet nor Columbia shall be liable to the other for
damages for such termination. 

     

    13.9          Singular
and Plural Forms.  The use herein of the singular form shall also
denote the plural form, and the use herein of the plural form shall denote the
singular form, as in each case the context may require.

     

    13.10      Headings. 
The headings contained in this Agreement are for convenience of reference only
and shall not constitute a part hereof or define, limit or otherwise affect the
meaning of any of the terms or provisions hereof.

     

    13.11      Counterparts. 
This Agreement may be executed in one or more counterparts, each of which shall
be deemed an original, but all of which, when taken together, shall constitute
one and the same instrument.

     

    13.12      Technical
Agreement. 
Columbia and Fleet are parties to that certain Technical Agreement dated
December 7, 2009, the terms of which outline the responsibilities of Columbia
and Fleet with respect to assuring the quality of the Product.  Columbia
and Fleet acknowledge and agree that in the event the terms of this Agreement
and the Technical Agreement conflict or are inconsistent, the terms of this
Agreement shall prevail over the terms of the Technical Agreement; provided
however, that to the extent possible, the terms of both the Technical Agreement
and this Agreement shall be read and considered to effect the intent of the
parties.

     

    IN WITNESS WHEREOF,
the parties have caused this Agreement to be executed by their respective duly
authorized officers as of the date first above written.

     

    FLEET LABORATORIES
LIMITED                     
COLUMBIA LABORATORIES (BERMUDA), LTD.

     

     

     

     

     

     

     

    
      	
              By:

               

            	
              /S/ Tom
      Homer

               

            	
               

               

            	
              By:

               

            	
              /S/ Robert S.
      Mills

               

            
	
               

               

            	
               

               

            	
               

               

            	
               

               

            	
               

               

            
	
              Name:

               

            	
              Tom
      Homer

               

            	
               

               

            	
              Name:

               

            	
              Robert S
      Mills

               

            
	
               

               

            	
               

               

            	
               

               

            	
               

               

            	
               

               

            
	
              Title:

               

            	
              Managing
      Director

               

            	
               

               

            	
              Title:

               

            	
              President

               

            
	
               

               

            	
               

               

            	
               

               

            	
               

               

            	
               

               

            
	
               

               

            	
               

               

            	
               

               

            	
               

               

            	
               

               

            

    

     

     

     

     

     

     

    Exhibit A
Intentionally OmittedExhibit 10.1

 

CHANGE OF CONTROL EMPLOYMENT AGREEMENT

 

CHANGE OF CONTROL EMPLOYMENT AGREEMENT by and between Medtronic, Inc., a Minnesota corporation (the “Company”), and ________________________ (the “Executive”), dated as of the ______ day of ____________________.

 

The Board of Directors of the Company (the “Board”) has determined that it is in the best interests of the Company and its shareholders to assure that the Company will have the continued dedication of the Executive, notwithstanding the possibility, threat or occurrence of a Change of Control (as defined in Section 2) of the Company. The Board believes it is imperative to diminish the inevitable distraction of the Executive by virtue of the personal uncertainties and risks created by a pending or threatened Change of Control and to encourage the Executive’s full attention and dedication to the Company currently and in the event of any threatened or pending Change of Control, and to provide the Executive with compensation and benefits arrangements upon a Change of Control which are competitive with those of other corporations and which ensure that the compensation and benefits
expectations of the Executive will be satisfied. Therefore, in order to accomplish these objectives, the Board has caused the Company to enter into this Agreement.

 

NOW, THEREFORE, IT IS HEREBY AGREED AS FOLLOWS:

 

1.         Certain Definitions.

 

(a)        The “Effective Date” shall mean the first date during the Change of Control Period (as defined in Section l(b)) on which a Change of Control) occurs. Anything in this Agreement to the contrary notwithstanding, if (i) the Executive’s employment with the Company is terminated by the Company or the Executive terminates employment because the Executive ceases to be an officer of the Company, (ii) the Date of Termination occurs prior to the date on which a Change of Control occurs, and (iii) it is reasonably demonstrated by the Executive that such termination of employment or cessation of status as an officer (A) was at the request of a third party who has taken steps reasonably calculated to effect the Change of Control or (B) otherwise arose in connection with or anticipation of the Change of Control, then for all purposes of this
Agreement the “Effective Date” shall mean the date immediately prior to such Date of Termination.

 

(b)        The “Change of Control Period” shall mean the period commencing on the date hereof and ending on the third anniversary of such date; provided, however, that commencing on the date one year after the date hereof, and on each annual anniversary of such date (such date and each annual anniversary thereof shall be hereinafter referred to as the “Renewal Date”), unless previously terminated, the Change of Control Period shall be automatically extended so as to terminate three years from such Renewal Date, unless at least 60 days prior to the Renewal Date the Company shall give written notice to the Executive that the Change of Control Period shall not be so extended.

 

2.         Change of Control. For the purpose of this Agreement, a “Change of Control” shall mean:

 

(a)        Any individual, entity or group (within the meaning of Section 13(d)(3) or 14(d)(2) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) (a “Person) becomes the beneficial owner (within the meaning of Rule 13d-3 promulgated under the Exchange Act) of 30% or more of either (i) the then-outstanding shares of common stock of the Company (the “Outstanding Company Common Stock”) or (ii) the combined voting power of the then-outstanding voting securities of the Company entitled to vote generally in the election of directors (the “Outstanding Company Voting Securities”); provided, however, that, for purposes of this Section 2(a), the following acquisitions shall not constitute a
Change of Control:  (1) any acquisition directly from the Company, (2) any acquisition by the Company or any of its subsidiaries, (3) any acquisition by any employee benefit plan (or related trust) sponsored or maintained by the Company or any of its subsidiaries, (4) any acquisition by an underwriter temporarily holding securities pursuant to an offering of such securities or (5) any acquisition pursuant to a transaction that complies with clauses (i), (ii) and (iii) of Section 2(c); or

 

(b)        Individuals who, as of the date hereof, constitute the Board (the “Incumbent Directors”) cease for any reason to constitute at least a majority of the Board; provided, however, that any individual becoming a director subsequent to the date hereof whose election, or nomination for election by the Company’s shareholders, was approved by a vote of at least a majority of the Incumbent Directors then on the Board shall be considered as though such individual was an Incumbent Director, but excluding, for this purpose, any such individual whose initial assumption of office occurs as a result of either an actual or threatened election contest or other actual or threatened solicitation of proxies or consents by or on behalf
of a Person other than the Board; or

 

(c)        Consummation of a reorganization, merger, statutory share exchange or consolidation (or similar corporate transaction) involving the Company or any of its subsidiaries, a sale or other disposition of all or substantially all of the assets of the Company, or the acquisition of assets or stock of another entity by the Company or any of its subsidiaries (each, a “Business Combination”), in each case, unless, immediately following such Business Combination, (i) substantially all of the individuals and entities who were the beneficial owners, respectively, of the Outstanding Company Common Stock and the Outstanding Company Voting Securities immediately prior to such Business Combination beneficially own, directly or indirectly, more than 50% of, respectively, the then-outstanding shares of common stock (or, for a
non-corporate entity, equivalent securities) and the then-outstanding voting securities entitled to vote generally in the election of directors (or, for a non-corporate entity, equivalent governing body), as the case may be, of (A) the entity resulting from such Business Combination (the “Surviving Corporation”) or (B) if applicable, the ultimate parent entity that directly or indirectly has beneficial ownership of 80% or more of the voting securities eligible to elect directors of the Surviving Corporation (the “Parent Corporation”), in substantially the same proportion as their ownership, immediately prior to the Business Combination, of the Outstanding Company Common Stock and the Outstanding Company Voting Securities, as the case may be, (ii) no person (other than any employee benefit plan (or related trust) sponsored or maintained by the Surviving Corporation or the Parent Corporation), is or becomes the beneficial owner, directly or indirectly, of 30% or more
of the outstanding shares of common stock and the total voting power of the outstanding voting securities eligible to elect directors of the Parent Corporation (or, if there is no Parent Corporation, the Surviving Corporation) and (iii) at least a majority of the members of the board of directors of the Parent Corporation (or, if there is no Parent Corporation, the Surviving Corporation) following the consummation of the Business Combination were Incumbent Directors at the time of the Board’s approval of the execution of the initial agreement providing for such Business Combination; or

 

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(d)        Approval by the shareholders of the Company of a complete liquidation or dissolution of the Company.

 

3.         Employment Period. The Company hereby agrees to continue the Executive in its employ, and the Executive hereby agrees to remain in the employ of the Company, for the period commencing on the Effective Date and ending on the third anniversary of such date (the “Employment Period”), provided, that nothing stated in this Agreement shall restrict the right of the Company or the Executive at any time to terminate the Executive’s employment with the Company, subject to the obligations of the Company provided for in this Agreement in the event of such terminations. The Employment Period shall terminate upon the Executive’s termination of employment for any reason.

 

4.         Terms of Employment.

 

(a)        Position and Duties.

 

(i)         During the Employment Period, (A) the Executive’s position (including status, offices, titles and reporting requirements), authority, duties and responsibilities shall be at least commensurate in all material respects with the most significant of those held, exercised and assigned at any time during the 90-day period immediately preceding the Effective Date; and (B) the Executive’s services shall be performed at the location where the Executive was employed immediately preceding the Effective Date or any office or location less than 50 miles from such location.

 

(ii)        Except as otherwise expressly provided in this Agreement, during the Employment Period, and excluding any periods of vacation and sick leave to which the Executive is entitled, the Executive agrees to devote reasonable attention and time during normal business hours to the business and affairs of the Company and, to the extent necessary to discharge the responsibilities assigned to the Executive hereunder, to use the Executive’s reasonable best efforts to perform faithfully and efficiently such responsibilities. During the Employment Period, it shall not be a violation of this Agreement for the Executive to (A) serve on corporate, civic or charitable boards or committees, (B) deliver lectures, fulfill speaking engagements or teach at educational institutions and (C) manage personal investments, so long as such activities do not
significantly interfere with the performance of the Executive’s responsibilities as an employee of the Company in accordance with this Agreement. It is expressly understood and agreed that to the extent that any such activities have been conducted by the Executive prior to the Effective Date, the continued conduct of such activities (or the conduct of activities similar in nature and scope thereto) subsequent to the Effective Date shall not thereafter be deemed to interfere with the performance of the Executive’s responsibilities to the Company.

 

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(b)         Compensation.

 

(i)         Base Salary. During the Employment Period, the Executive shall receive an annual base salary (“Annual Base Salary”) at an annual rate at least equal to 12 times the highest monthly base salary paid or payable, including any base salary that has been earned but deferred, to the Executive by the Company and the affiliated companies in respect of the 12-month period immediately preceding the month in which the Effective Date occurs. The Annual Base Salary shall be paid at such intervals as the Company pays executive salaries generally. During the Employment Period, the Annual Base Salary shall be reviewed at least annually and shall be increased at any time and from time to time as shall be substantially consistent with increases in base salary generally awarded in the ordinary
course of business to other peer executives of the Company and its affiliated companies. Any increase in Annual Base Salary shall not serve to limit or reduce any other obligation to the Executive under this Agreement. Annual Base Salary shall not be reduced after any such increase and the term “Annual Base Salary” as utilized in this Agreement shall refer to Annual Base Salary as so increased. As used in this Agreement, the term “affiliated companies” shall include any company controlled by, controlling or under common control with the Company.

 

(ii)        Annual Incentive Payments. In addition to Annual Base Salary, the Executive shall be paid, for each fiscal year ending during the Employment Period, an annual bonus (“Annual Bonus”) in cash at least equal to the Executive’s average annual or annualized (for any fiscal year consisting of less than 12 full months or with respect to which the Executive has been employed by the Company for less than 12 full months) award earned by the Executive, including any award earned but deferred, under the Company’s Executive Incentive Plan, as amended from time to time prior to the Effective Date (or under any successor or replacement annual incentive plan of the Company or any of the affiliated companies), for the last three fiscal years immediately preceding the fiscal year in which the
Effective Date occurs (the “Three-Year Average Bonus”).  If the Executive has not been eligible to earn, or has not been employed, for each of the last three fiscal years immediately preceding the fiscal year during which the Effective Date occurs but has earned a bonus for at least one fiscal year during the last three fiscal years immediately preceding the fiscal year during which the Effective Date occurs, the “Three-Year Average Bonus” shall mean the average of any annual or annualized bonus actually earned over any such years. If the Executive has not been eligible to earn, or has not received, such a bonus for any fiscal year prior to the Effective Date, the “Three-Year Average  Bonus” shall mean the Executive’s Target Annual Bonus for the year during which the Effective Date occurs. Each such Annual Bonus shall be paid no later than two and a half months after the end of the fiscal year for which the Annual Bonus is awarded, unless the
Executive shall elect to defer the receipt of such Annual Bonus pursuant to an arrangement that meets the requirements of Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”).

 

(iii)       Long-Term Cash and Equity Incentives, Savings Plans and Retirement Plans. During the Employment Period, the Executive shall be entitled to participate in all long-term cash incentive, equity incentive, savings and retirement plans, practices, policies and programs (any such arrangement a “Plan” for purposes of this Agreement) applicable generally to other peer executives of the Company and the affiliated companies, but in no event shall such Plans provide the Executive with incentive opportunities (measured with respect to both regular and special incentive opportunities, to the extent, if any, that such distinction is applicable), savings opportunities and retirement benefit opportunities, in each case, less favorable, in the aggregate, than the most favorable of those provided by the
Company and the affiliated companies for the Executive under such Plans as in effect at any time during the 90-day period immediately preceding the Effective Date or, if more favorable to the Executive, those provided generally at any time after the Effective Date to other peer executives of the Company and the affiliated companies.

 

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(iv)       Welfare Benefit Plans. During the Employment Period, the Executive and/or the Executive’s family, as the case may be, shall be eligible for participation in and shall receive all benefits under welfare benefit Plans provided by the Company and the affiliated companies (including, without limitation, medical, prescription, dental, disability, salary continuance, employee life, group life, accidental death and travel accident insurance Plans) to the extent applicable generally to other peer executives of the Company and the affiliated companies, but in no event shall such Plans provide the Executive with benefits which are less favorable, in the aggregate, than the most favorable of such Plans in effect for the Executive at any time during the 90-day
period immediately preceding the Effective Date or, if more favorable to the Executive, those provided generally at any time after the Effective Date to other peer executives of the Company and the affiliated companies.

 

(v)        Expenses. During the Employment Period, the Executive shall be entitled to receive prompt reimbursement for all reasonable expenses incurred by the Executive in accordance with the most favorable policies, practices and procedures of the Company and the affiliated companies in effect for the Executive at any time during the 90-day period immediately preceding the Effective Date or, if more favorable to the Executive, as in effect generally at any time thereafter with respect to other peer executives of the Company and the affiliated companies.

 

(vi)       Business Allowance. During the Employment Period, the Executive shall be entitled to a business allowance in accordance with the most favorable Plans of the Company and the affiliated companies in effect for the Executive at any time during the 90-day period immediately preceding the Effective Date or, if more favorable to the Executive, as in effect generally at any time thereafter with respect to other peer executives of the Company and the affiliated companies.

 

(vii)      Office and Support Staff. During the Employment Period, the Executive shall be entitled to an office or offices of a size and with furnishings and other appointments, and to exclusive personal secretarial and other assistance, at least equal to the most favorable of the foregoing provided to the Executive by the Company and the affiliated companies at any time during the 90-day period immediately preceding the Effective Date or, if more favorable to the Executive, as provided generally at any time thereafter with respect to other peer executives of the Company and the affiliated companies.

 

(viii)      Vacation. During the Employment Period, the Executive shall be entitled to paid vacations in accordance with the most favorable Plans of the Company and the affiliated companies as in effect for the Executive at any time during the 90-day period immediately preceding the Effective Date or, if more favorable to the Executive, as in effect generally at any time thereafter with respect to other peer executives of the Company and the affiliated companies.

 

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5.         Termination of Employment.

 

(a)        Death or Disability. The Executive’s employment shall terminate automatically upon the Executive’s death during the Employment Period. If the Company determines in good faith that the Disability of the Executive has occurred during the Employment Period (pursuant to the definition of Disability set forth below), it may give to the Executive written notice in accordance with Section 12(b) of this Agreement of its intention to terminate the Executive’s employment. In such event, the Executive’s employment with the Company shall terminate on the 30th day after receipt of such notice by the Executive (the “Disability Effective Date”), provided, that, within the 30 days after such
receipt, the Executive shall not have returned to full-time performance of the Executive’s duties. For purposes of this Agreement, “Disability” shall mean the absence of the Executive from the Executive’s duties with the Company on a full-time basis for 180 consecutive days as a result of incapacity due to mental or physical illness which is determined to be total and permanent by a physician selected by the Company or its insurers and acceptable to the Executive or the Executive’s legal representative (such agreement as to acceptability not to be unreasonably withheld).

 

(b)        Cause. (i)  The Company may terminate the Executive’s employment during the Employment Period with or without Cause. For purposes of this Agreement, “Cause” shall mean (A) repeated violations by the Executive of the Executive’s obligations under Section 4(a) of this Agreement (other than as a result of incapacity due to physical or mental illness) which are demonstrably willful and deliberate on the Executive’s part, which are not remedied in a reasonable period of time after receipt of written notice from the Company specifying such violations or (B) the conviction of the Executive of a felony involving moral turpitude.

 

(ii)        For purposes of Section 5(b)(i)(A) of this Agreement, no act, or failure to act, on the part of the Executive shall be considered “willful” unless it is done, or omitted to be done, by the Executive in bad faith and without reasonable belief that the Executive’s action or omission was in the best interests of the Company. Any act, or failure to act, based upon (A) authority given pursuant to a resolution duly adopted by the Board, or if the Company is not the ultimate parent corporation of the affiliated companies and is not publicly traded, the board of directors of the Parent Corporation (the “Applicable Board”), (B) the instructions of the Chief Executive Officer of the Company or the Parent Corporation or a senior officer of the Company or the Parent Corporation or (C) the advice of counsel for the Company or
the Parent Corporation shall be conclusively presumed to be done, or omitted to be done, by the Executive in good faith and in the best interests of the Company. The cessation of employment of the Executive shall not be deemed to be for Cause unless and until there shall have been delivered to the Executive a copy of a resolution duly adopted by the affirmative vote of not less than three-quarters of the entire membership of the Applicable Board (excluding the Executive, if the Executive is a member of the Applicable Board) at a meeting of the Applicable Board called and held for such purpose (after reasonable notice is provided to the Executive and the Executive is given an opportunity, together with counsel for the Executive, to be heard before the Applicable Board), finding that, in the good faith opinion of the Applicable Board, the Executive is guilty of the conduct described in Section 5(b)(i)(A) of this Agreement, and specifying the particulars thereof in detail.

 

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(c)        Good Reason. The Executive’s employment may be terminated by the Executive for Good Reason or by the Executive voluntarily without Good Reason. For purposes of this Agreement, “Good Reason” shall mean:

 

(i)         the assignment to the Executive of any duties inconsistent in any respect with the Executive’s position (including status, offices, titles and reporting requirements), authority, duties or responsibilities as contemplated by Section 4(a) of this Agreement, or any diminution in such position, authority, duties or responsibilities (whether or not occurring solely as a result of the Company ceasing to be a publicly traded entity or becoming a subsidiary), excluding for this purpose an isolated, insubstantial and inadvertent action not taken in bad faith and that is remedied by the Company promptly after receipt of notice thereof given by the Executive;

 

(ii)        any failure by the Company to comply with any of the provisions of Section 4(b) of this Agreement, other than an isolated, insubstantial and inadvertent failure not occurring in bad faith and that is remedied by the Company promptly after receipt of notice thereof given by the Executive;

 

(iii)       the Company’s requiring the Executive to be based at any office or location other than that described in Section 4(a)(i)(B) of this Agreement or the Company’s requiring the Executive to be based at a location other than the principal executive offices of the Company (if the Executive were employed at such location immediately preceding the Effective Date) or the Company’s requiring the Executive to travel on Company business to a substantially greater extent than required immediately prior to the Effective Date; 

 

(iv)       any purported termination by the Company of the Executive’s employment otherwise than as expressly permitted by this Agreement; or

 

(v)        any failure by the Company to comply with and satisfy Section 11(c) of this Agreement.

 

For purposes of this Section 5(c) of this Agreement, any good faith determination of “Good Reason” made by the Executive shall be conclusive. The Executive’s mental or physical incapacity following the occurrence of an event described above in clauses (i) through (v) shall not affect the Executive’s ability to terminate employment for Good Reason.

 

(d)        Notice of Termination. Any termination by the Company for Cause, or by the Executive for Good Reason, shall be communicated by Notice of Termination to the other party hereto given in accordance with Section 12(b) of this Agreement. For purposes of this Agreement, a “Notice of Termination” means a written notice which (i) indicates the specific termination provision in this Agreement relied upon, (ii) to the extent applicable, sets forth in reasonable detail the facts and circumstances claimed to provide a basis for termination of the Executive’s employment under the provision so indicated and (iii) if the Date of Termination (as defined herein) is other than the date of receipt of such notice, specifies the Date of Termination (which Date of Termination shall be not more than 30
days after the giving of such notice). The failure by the Executive or the Company to set forth in the Notice of Termination any fact or circumstance that contributes to a showing of Good Reason or Cause, respectively, shall not waive any right of the Executive or the Company, respectively, hereunder or preclude the Executive or the Company from asserting such fact or circumstance in enforcing the Executive’s or the Company’s respective rights hereunder.

 

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(e)        Date of Termination. “Date of Termination” means (i) if the Executive’s employment is terminated by the Company for Cause, or by the Executive for Good Reason, the date of receipt of the Notice of Termination or any later date specified in the Notice of Termination, as the case may be, (ii) if the Executive’s employment is terminated by the Company other than for Cause or Disability or death, the Date of Termination shall be the date on which the Company notifies the Executive of such termination, (iii) if the Executive resigns without Good Reason, the date on which the Executive notifies the Company of such termination and (iv) if the Executive’s employment is terminated by reason of death or Disability, the Date of Termination shall be the date of death of the Executive
or the Disability Effective Date, as the case may be. Notwithstanding the foregoing, in no event shall the Date of Termination occur until the Executive experiences a “separation from service” within the meaning of Section 409A of the Code, and the date on which such separation from service takes place shall be the “Date of Termination.”

 

6.         Obligations of the Company upon Termination.

 

(a)        Good Reason; Other Than for Cause, Death or Disability. If, during the Employment Period, the Company terminates the Executive’s employment other than for Cause or Disability or the Executive terminates employment for Good Reason, in lieu of further payments pursuant to Section 4(b) of this Agreement with respect to periods following the Date of Termination:

 

(i)         the Company shall pay to the Executive in a lump sum in cash within 30 days after the Date of Termination the aggregate of the following amounts:

 

(A)       the sum of (1) the Executive’s Annual Base Salary through the Date of Termination, and (2) any accrued vacation pay, in each case, to the extent not theretofore paid (the sum of the amounts described in subclauses (1) and (2), the “Accrued Obligations”);

 

(B)       an amount equal to the product of (1) the higher of (I) the Three-Year Average Bonus and (II) the Annual Bonus paid or payable, including any portion thereof that has been earned but deferred (and annualized for any fiscal year consisting of less than 12 full months or during which the Executive has been employed for less than 12 full months), for the most recently completed fiscal year during the Employment Period, if any (such higher amount, the “Highest Annual Bonus”), and (2) a fraction, the numerator of which is the number of days in the current fiscal year through the Date of Termination, and the denominator of which is 365, in lieu of any amounts otherwise payable pursuant to the Executive Incentive Plan solely with respect to the year in which the Date of Termination occurs (the “Pro-Rata Incentive Payment”); and

 

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(C)       the amount equal to the product of (1) three, and (2) the sum of (x) the Executive’s Annual Base Salary, and (y) the Highest Annual Bonus; and

 

(ii)        the Executive’s benefits under the Company’s tax qualified retirement plan (the “Retirement Plan”) and any excess or supplemental retirement plan in which the Executive participates as of the Effective Date (or if more favorable to the Executive, as of the Date of Termination) (collectively, the “SERP”) shall be calculated assuming that the Executive’s employment continued for the remainder of the Employment Period and that during such period the Executive received service credit for all purposes under such plans and the Executive’s age increased by the number of years that the Executive is deemed to be so employed; provided, however; that in no event shall the Executive be entitled to age or service credit,
as a result of the application of this Section 6(a)(ii), beyond the maximum age or maximum number of years of service credit, as applicable, permitted under the Retirement Plan or the SERP; and

 

(iii)       for the remainder of the Employment Period, or such longer period as any plan, program, practice or policy may provide (the “Benefit Continuation Period”), the Company shall provide health care and life insurance benefits to the Executive and/or the Executive’s family at least equal to, and at the same after-tax cost to the Executive and/or the Executive’s family (taking into account any applicable required employee contributions), as those which would have been provided to them in accordance with the Plans providing health care and life insurance benefits and at the benefit level described in Section 4(b)(iv) of this Agreement if the Executive’s employment had not been terminated; provided, however, that the health care
benefits provided during the Benefit Continuation Period shall be provided in such a manner that such benefits (and the costs and premiums thereof) are excluded from the Executive’s income for federal income tax purposes and, if the Company reasonably determines that providing continued coverage under one or more of its health care benefit plans contemplated herein could be taxable to the Executive, the Company shall provide such benefits at the level required hereby through the purchase of individual insurance coverage; provided, further, that if the Executive becomes re-employed with another employer and is eligible to receive health care and life insurance benefits under another employer-provided plan, the health care and life benefits provided hereunder shall be secondary to those provided under such other plan during such applicable period of eligibility. Following the end of the
Benefit Continuation Period, the Executive shall be eligible for continued health coverage as required by Section 4980B of the Code or other applicable law (“COBRA Coverage”), as if the Executive’s employment with the Company had terminated as of the end of such period, and the Company shall take such actions as are necessary to cause such COBRA Coverage not to be offset by the provision of benefits under this Section 6(a)(iii) and to cause the period of COBRA Coverage to commence at the end of the Benefit Continuation Period. For purposes of determining eligibility (but not the time of commencement of benefits) of the Executive for retiree welfare benefits pursuant to the retiree welfare benefit Plans, the Executive shall be considered to have remained employed until the end of the Employment Period and to have retired on the last day of such period, and the Company shall cause the Executive to be eligible to commence in the applicable retiree welfare benefit Plans as
of the applicable benefit commencement date; and

 

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(iv)       except as otherwise set forth in the last sentence of Section 7, to the extent not theretofore paid or provided, the Company shall timely pay or provide to the Executive any other amounts or benefits that the Executive is otherwise entitled to receive under any other plan, program, practice, policy, contract, arrangement or agreement of the Company or the affiliated companies (such other amounts and benefits, the “Other Benefits”).

 

Notwithstanding the foregoing provisions of Section 6(a)(i), in the event that the Executive is a “specified employee” within the meaning of Section 409A of the Code (as determined in accordance with the methodology established by the Company as in effect on the Date of Termination) (a “Specified Employee”), amounts that would otherwise be payable under Section 6(a)(i) during the six-month period immediately following the Date of Termination (other than the Accrued Obligations) shall instead be paid, with interest on any delayed payment at the applicable federal rate provided for in Section 7872(f)(2)(A) of the Code (“Interest”), on the first business day after the date that is six months following the Executive’s “separation from service” within the meaning of Section 409A of the Code (the “409A Payment Date”). 

 

(b)        Death. If the Executive’s employment is terminated by reason of the Executive’s death during the Employment Period, the Company shall provide the Executive’s estate or beneficiaries with the Accrued Obligations, the Pro-Rata Incentive Payment and the timely payment or delivery of the Other Benefits, and shall have no other severance obligations under this Agreement. The Accrued Obligations shall be paid to the Executive’s estate or beneficiary, as applicable, in a lump sum in cash within 30 days of the Date of Termination. With respect to the provision of the Other Benefits, the term “Other Benefits” as used in this Section 6(b) shall include, without limitation, and the Executive’s estate and/or beneficiaries shall be entitled to receive, benefits at least equal
to the most favorable benefits provided by the Company and the affiliated companies to the estates and beneficiaries of peer executives of the Company and the affiliated companies under such Plans relating to death benefits, if any, as in effect with respect to other peer executives and their beneficiaries at any time during the 90-day period immediately preceding the Effective Date or, if more favorable to the Executive’s estate and/or the Executive’s beneficiaries, as in effect on the date of the Executive’s death with respect to other peer executives of the Company and the affiliated companies and their beneficiaries.

 

(c)        Disability. If the Executive’s employment is terminated by reason of the Executive’s Disability during the Employment Period, the Company shall provide the Executive with the Accrued Obligations and the Pro-Rata Incentive Payment the timely payment or delivery of the Other Benefits in accordance with the terms of the underlying plans or agreements, and shall have no other severance obligations under this Agreement. The Accrued Obligations and the Pro-Rata Incentive Payment shall be paid to the Executive in a lump sum in cash within 30 days of the Date of Termination, provided, that in the event that the Executive is a Specified Employee, the Pro-Rata Incentive Payment shall be paid, with Interest, to the Executive on the 409A Payment Date.
With respect to the provision of the Other Benefits, the term “Other Benefits” as used in this Section 6(c) shall include, and the Executive shall be entitled after the Disability Effective Date to receive, disability and other benefits at least equal to the most favorable of those generally provided by the Company and the affiliated companies to disabled executives and/or their families in accordance with such Plans relating to disability, if any, as in effect generally with respect to other peer executives and their families at any time during the 90-day period immediately preceding the Effective Date or, if more favorable to the Executive and/or the Executive’s family, as in effect at any time thereafter generally with respect to other disabled peer executives of the Company and the affiliated companies and their families.

 

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(d)        Cause; Other Than for Good Reason. If the Executive’s employment is terminated for Cause during the Employment Period, the Company shall provide to the Executive (i) the Accrued Obligations and (ii) the Other Benefits, in each case to the extent theretofore unpaid, and shall have no other severance obligations under this Agreement. If the Executive voluntarily terminates employment during the Employment Period, excluding a termination for Good Reason, the Company shall provide to the Executive the Accrued Obligations and the Pro-Rata Incentive Payment and the timely payment or delivery of the Other Benefits, and shall have no other severance obligations under this Agreement. In such case, the Accrued Obligations and the Pro-Rata Incentive Payment shall be paid to the Executive in a lump sum
in cash within 30 days of the Date of Termination, provided, that in the event that the Executive is a Specified Employee, the Pro-Rata Incentive Payment shall be paid, with Interest, to the Executive on the 409A Payment Date.

 

7.         Non-Exclusivity of Rights. Nothing in this Agreement shall prevent or limit the Executive’s continuing or future participation in any plan, program, policy or practice provided by the Company or any of the affiliated companies (other than participation in any severance plan upon the Executive’s termination of employment during the Employment Period) and for which the Executive may qualify, nor, subject to Section 12(f) of this Agreement, shall anything herein limit or otherwise affect such rights as the Executive may have under any contract or agreement with the Company or any of the affiliated companies. Amounts which are vested benefits or which the Executive is otherwise entitled to receive under any plan, policy, practice or program of or any contract or agreement with the
Company or any of the affiliated companies at or subsequent to the Date of Termination shall be payable in accordance with such plan, policy, practice or program or contract or agreement except as explicitly modified by this Agreement. Without limiting the generality of the foregoing, the Executive’s resignation under this Agreement with or without Good Reason, shall in no way affect the Executive’s ability to terminate employment by reason of the Executive’s “retirement” under any compensation and benefits plans, programs or arrangements of the affiliated companies, including without limitation any retirement or pension plans or arrangements or to be eligible to receive benefits under any compensation or benefit plans, programs or arrangements of the affiliated companies, including without limitation any retirement or pension plan or arrangement of the affiliated companies or substitute plans adopted by the Company or its successors, and any termination which
otherwise qualifies as Good Reason shall be treated as such even if it is also a “retirement” for purposes of any such plan. Notwithstanding the foregoing, if the Executive receives payments and benefits pursuant to Section 6(a) of this Agreement, the Executive shall not be entitled to any other severance pay or benefits under any severance plan, program or policy of the Company or the affiliated companies, unless expressly provided therein in a specific reference to this Agreement.

 

8.         Full Settlement; Legal Fees. The Company’s obligation to make the payments provided for in this Agreement and otherwise to perform its obligations hereunder shall not be affected by any set-off, counterclaim, recoupment, defense or other claim, right or action which the Company may have against the Executive or others. In no event shall the Executive be obligated to seek other employment or take any other action by way of mitigation of the amounts payable to the Executive under any of the provisions of this Agreement and such amounts shall not be reduced whether or not the Executive obtains other employment. The Company agrees to pay as incurred (within 10 days following the Company’s receipt of an invoice from the Executive) at any time from the Effective Date of this Agreement
through the Executive’s remaining lifetime (or, if longer, through the 20th anniversary of the Effective Date), to the full extent permitted by law, all legal fees and expenses which the Executive may reasonably incur as a result of any contest (regardless of the outcome thereof) by the Company, the Executive or others of the validity or enforceability of, or liability under, any provision of this Agreement or any guarantee of performance thereof (including as a result of any contest by the Executive about the amount of any payment pursuant to this Agreement), plus, in each case, Interest, provided, that the Executive shall have submitted an invoice for such fees and expenses at least 10 days before the end of the calendar year next following the calendar year in which such fees and expenses were incurred. The amount of such legal fees and expenses that the Company is obligated to pay in any given calendar year shall not affect the
legal fees and expenses that the Company is obligated to pay in any other calendar year.

 

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9.         Reduction of Payments in Certain Circumstances.

 

(a)        Anything in this Agreement to the contrary notwithstanding, in the event PricewaterhouseCoopers or such other nationally recognized certified public accounting firm as may be designated by the Company (the “Accounting Firm”) shall determine that receipt of all payments or distributions by the Company or the affiliated companies in the nature of compensation to or for the Executive’s benefit, whether paid or payable pursuant to this Agreement or otherwise (a “Payment”) would subject the Executive to the excise tax under Section 4999 of the Code, the Accounting Firm shall determine whether to reduce any of the Payments paid or payable pursuant to this Agreement (the “Agreement Payments”) to the Reduced Amount (as defined below). The Agreement Payments shall be reduced to the Reduced Amount only if the
Accounting Firm determines that the Executive would have a greater Net After-Tax Receipt (as defined below) of aggregate Payments if the Executive’s Agreement Payments were reduced to the Reduced Amount. If the Accounting Firm determines that the Executive would not have a greater Net After-Tax Receipt of aggregate Payments if the Executive’s Agreement Payments were so reduced, the Executive shall receive all Agreement Payments to which the Executive is entitled under this Agreement. For purposes of this Section 9, (i) “Reduced Amount” shall mean the greatest amount of Agreement Payments that can be paid that would not result in the imposition of the excise tax under Section 4999 of the Code if the Accounting Firm determines to reduce Agreement Payments pursuant to Section 9(a); and (ii) “Net After-Tax Receipt” shall mean the present value (as determined in accordance with Sections 280G(b)(2)(A)(ii) and 280G(d)(4) of the Code) of a Payment net of all
taxes imposed on the Executive with respect thereto under Sections 1 and 4999 of the Code and under applicable state and local laws, determined by applying the highest marginal rate under Section 1 of the Code and under state and local laws which applied to the Executive’s taxable income for the immediately preceding taxable year, or such other rate(s) as the Accounting Firm determined to be likely to apply to the Executive in the relevant tax year(s).

 

(b)        If the Accounting Firm determines that aggregate Agreement Payments should be reduced to the Reduced Amount, the Company shall promptly give the Executive notice to that effect and a copy of the detailed calculation thereof. All determinations made by the Accounting Firm under this Section 9 shall be binding upon the Company and the Executive and shall be made as soon as reasonably practicable and in no event later than fifteen (15) days following the Date of Termination. For purposes of reducing the Agreement Payments to the Reduced Amount, only amounts payable under this Agreement (and no other Payments) shall be reduced. The reduction of the amounts payable hereunder, if applicable, shall be made by reducing the payments and benefits under the following sections in the following order:   (i) Section 6(a)(1)(C), (ii) Section 6(a)(1)(B),
(iii) Section 6(a)(iii) and (iv) Section 6(a)(ii). All fees and expenses of the Accounting Firm shall be borne solely by the Company.

 

(c)        As a result of the uncertainty in the application of Section 4999 of the Code at the time of the initial determination by the Accounting Firm hereunder, it is possible that amounts will have been paid or distributed by the Company to or for the benefit of the Executive pursuant to this Agreement which should not have been so paid or distributed (“Overpayment”) or that additional amounts which will have not been paid or distributed by the Company to or for the benefit of the Executive pursuant to this Agreement could have been so paid or distributed (“Underpayment”), in each case, consistent with the calculation of the Reduced Amount hereunder. In the event that the Accounting Firm, based upon the assertion of a deficiency by the Internal Revenue Service against either the Company or the Executive which the Accounting Firm
believes has a high probability of success determines that an Overpayment has been made, the Executive shall pay any such Overpayment to the Company together with interest at the applicable federal rate provided for in Section 7872(f)(2) of the Code; provided, however, that no amount shall be payable by the Executive to the Company if and to the extent such payment would not either reduce the amount on which the Executive is subject to tax under Section 1 and Section 4999 of the Code or generate a refund of such taxes. In the event that the Accounting Firm, based upon controlling precedent or substantial authority, determines that an Underpayment has occurred, any such Underpayment shall be paid promptly (and in no event later than 60 days following the date on which the Underpayment is determined) by the Company to or for the benefit of the Executive together with interest at the applicable federal rate provided for in Section 7872(f)(2)
of the Code.

 

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10.       Confidential Information. The Executive shall comply with any and all confidentiality agreements with the Company to which the Executive is, or shall be, a party.

 

11.       Successors.

 

(a)        This Agreement is personal to the Executive and without the prior written consent of the Company shall not be assignable by the Executive other than by will or the laws of descent and distribution. This Agreement shall inure to the benefit of and be enforceable by the Executive’s legal representatives.

 

(b)        This Agreement shall inure to the benefit of and be binding upon the Company and its successors and assigns. Except as provided in Section 11(c) of this Agreement, this Agreement shall not be assignable by the Company.

 

(c)        The Company will require any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business and/or assets of the Company to assume expressly and agree to perform this Agreement in the same manner and to the same extent that the Company would be required to perform it if no such succession had taken place. As used in this Agreement, “Company” shall mean the Company as hereinbefore defined and any successor to its business and/or assets as aforesaid which assumes and agrees to perform this Agreement by operation of law or otherwise.

 

12.       Miscellaneous.

 

(a)        This Agreement shall be governed by and construed in accordance with the laws of the State of Minnesota, without reference to principles of conflict of laws. The captions of this Agreement are not part of the provisions hereof and shall have no force or effect. This Agreement may not be amended or modified otherwise than by a written agreement executed by the parties hereto or their respective successors and legal representatives.

 

(b)        All notices and other communications hereunder shall be in writing and shall be given by hand delivery to the other party or by registered or certified mail, return receipt requested, postage prepaid, addressed as follows:

 

If to the Executive:

 

At the most recent address on file at the Company.

 

If to the Company: 

 

Medtronic, Inc.

Legal Dept. LC400

710 Medtronic Parkway

Minneapolis, MN  55432-5604

Attention:  General Counsel

 

or to such other address as either party shall have furnished to the other in writing in accordance herewith. Notices and communications shall be effective when actually received by the addressee.

 

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(c)        The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement.

 

(d)        The Company may withhold from any amounts payable under this Agreement such United States federal, state, or local or foreign taxes as shall be required to be withheld pursuant to any applicable law or regulation.

 

(e)        The Executive’s or the Company’s failure to insist upon strict compliance with any provision of this Agreement or the failure to assert any right the Executive or the Company may have hereunder, including, without limitation, the right of the Executive to terminate employment for Good Reason pursuant to Sections 5(c)(i) through 5(c)(v) of this Agreement, shall not be deemed to be a waiver of such provision or right or any other provision or right of this Agreement.

 

(f)        The Executive and the Company acknowledge that, except as may otherwise be provided under any other written agreement between the Executive and the Company, the employment of the Executive by the Company may be terminated by either the Executive or the Company at any time prior to the Effective Date or, subject to the obligations of the Company provided for in this Agreement in the event of a termination after the Effective Date, at any time on or after the Effective Date. Moreover, if prior to the Effective Date, (i) the Executive’s employment with the Company terminates or (ii) the Executive ceases to be an officer of the Company, then the Executive shall have no further rights under this Agreement. From and after the Effective Date, except with respect to the agreements described in Section 10 hereof, this Agreement shall supersede any
other agreement between the parties with respect to the subject matter hereof in effect immediately prior to the execution of this Agreement.

 

(g)        The Agreement is intended to comply with the requirements of Section 409A of the Code or an exemption or exclusion therefrom and, with respect to amounts that are subject to Section 409A of the Code, shall in all respects be administered in accordance with Section 409A of the Code. Each payment under this Agreement shall be treated as a separate payment for purposes of Section 409A of the Code. In no event may the Executive, directly or indirectly, designate the calendar year of any payment to be made under this Agreement. If the Executive dies following the Date of Termination and prior to the payment of any amounts delayed on account of Section 409A of the Code, such amounts shall be paid to the personal representative of the Executive’s estate within 30 days after the date of the Executive’s death. All reimbursements and in-kind
benefits provided under this Agreement that constitute deferred compensation within the meaning of Section 409A of the Code shall be made or provided in accordance with the requirements of Section 409A of the Code, including, without limitation, that (i) in no event shall reimbursements by the Company under this Agreement be made later than the end of the calendar year next following the calendar year in which the applicable fees and expenses were incurred, provided, that the Executive shall have submitted an invoice for such fees and expenses at least 10 days before the end of the calendar year next following the calendar year in which such fees and expenses were incurred; (ii) the amount of in-kind benefits that the Company is obligated to pay or provide in any given calendar year shall not affect the in-kind benefits that the Company is obligated to pay or provide in any other calendar year; (iii) the Executive’s right to have the Company pay or provide such reimbursements and
in-kind benefits may not be liquidated or exchanged for any other benefit; and (iv) in no event shall the Company’s obligations to make such reimbursements or to provide such in-kind benefits apply later than the Executive’s remaining lifetime (or if longer, through the 20th anniversary of the Effective Date). Prior to the Effective Date but within the time period permitted by the applicable Treasury Regulations (or such later time as may be permitted under Section 409A or any IRS or Department of Treasury rules or other guidance issued thereunder), the Company may, in consultation with the Executive, modify the Agreement, in the least restrictive manner necessary and without any diminution in the value of the payments to the Executive, in order to cause the provisions of the Agreement to comply with the requirements of Section 409A of the Code, so as to avoid the imposition of taxes and penalties on the Executive pursuant to Section 409A of the Code.

 

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IN WITNESS WHEREOF, the Executive has hereunto set the Executive’s hand and, pursuant to the authorization from its Board of Directors, the Company has caused these presents to be executed in its name on its behalf, all as of the day and year first above written.

 

	
EXECUTIVE
 	
 
 	
MEDTRONIC, INC.
 
	
 
 	
 
 	
 
 
	
 
 	
 
 	
 
 
	
By:
 	
 
 	
 
 	
By:
 	
 
 
	
 
 	
[Name]

 

[Title]
 	
 
 	
 
 	
[Name]

 

[Title]
 

 

 

 

 

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