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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 Omitted
 
 
 

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