Exhibit 10.7
SALES AGENCY AGREEMENT (this "Agreement"), dated as of October 18, 2004
(the "Effective Date"), between Ortec International, Inc., a Delaware
corporation ("Ortec"), and Cambrex Bio Science Walkersville, Inc., a Delaware
corporation ("Agent").
RECITALS
WHEREAS, Ortec has certain rights in the Territory (as defined below)
in and to Orcel'r', which enable Ortec to make, have made, use and, following
regulatory approval, sell Orcel'r' in the Territory;
WHEREAS, Agent manufactures Orcel'r' for Ortec pursuant to the Cell
Therapy Manufacturing Agreement, dated as of October 29, 2003, between Agent and
Ortec (as amended, the "Manufacturing Agreement");
WHEREAS, Agent has and will acquire certain expertise in the marketing
of cell therapy products to customers in the Territory;
WHEREAS, Ortec desires to engage Agent as Ortec's exclusive agent to,
following regulatory approval, market and sell Orcel'r' on behalf of Ortec in
the Territory;
NOW, THEREFORE, in consideration of the foregoing and the mutual
promises and covenants hereinafter set forth, Ortec and Agent, intending to be
legally bound, hereby agree as follows:
1. DEFINITIONS.
"Affiliate" shall mean, with respect to either party, any other
corporation or business entity that directly, or indirectly through one or more
intermediaries, controls, is controlled by or is under common control with such
party. For purposes of this definition, the term "control" means direct or
indirect ownership of more than fifty percent (50%) of the securities or other
ownership interests representing the equity voting stock or general partnership
or membership interest of such entity or the power to direct or cause the
direction of the management or policies of such entity, whether through the
ownership of voting securities, by contract, resolution or otherwise.
"Adverse Event" shall mean any untoward medical occurrence in a patient
administered the Product and which does not necessarily have a causal
relationship with the Product. In the event that the definition of "adverse
event" is modified in the Territory by the FDA or any other applicable
governmental agency, the corresponding definition set forth in this Agreement
shall be modified accordingly.
"Applicable Sales Tax" shall mean any sales or similar transactional
tax (i) that is (x) imposed by a state or local jurisdiction in the United
States or any other jurisdiction and (y) designated in a written notice by Ortec
to Agent from time to time or (ii) imposed by a jurisdiction not designated by
Ortec and for which Agent is aware that a sales tax applies.
"Change in Control" of a party shall mean any of the following: (a) the
sale, lease conveyance or other disposition of all or substantially all of its
assets as an entity or substantially as an entity in one or more transactions;
(b) the consummation of any consolidation or merger (i) in which it is not the
continuing or surviving corporation or (ii) pursuant to which its shares would
be converted into cash, securities or other property, in each case other than a
consolidation or merger in which the holders of its shares immediately prior to
the consolidation or merger have, directly or indirectly, at least a majority of
the shares of the continuing or surviving corporation immediately after such
consolidation or merger; (c) any transaction or a series of transactions (as a
result of a tender offer, merger or consolidation) that results in the direct or
indirect acquisition of beneficial ownership of 50% or more of the aggregate
voting power of its capital stock entitled to vote generally in the election of
its directors; or (d) any transaction or a series of transactions that results
in the direct or indirect acquisition by any person, entity or "group" (within
the meaning of Section 13(d)(3) or 14(d)(2) of the Securities Exchange Act of
1934 but excluding for this purpose such party or its subsidiaries or any
employee benefit plan of such party or its subsidiaries which acquires
beneficial ownership of voting securities of such party) of beneficial ownership
of 50% or more of the aggregate voting power of its capital stock entitled to
vote generally in the election of its directors.
"Competitive Product" means, at the relevant time of determination, any
product used for the treatment of dermatological chronic or acute wound healing
(other than burn wounds).
"Consent and Agreement" means the Consent and Agreement, dated as of
the date hereof, between Agent and Xxxx Royalty.
"FDA" shall mean the United States Food and Drug Administration and any
successor agency thereto.
"Fully Burdened Costs" shall mean the fully burdened costs of Agent
determined in accordance with Exhibit C hereto.
"Launch Date" shall mean the later of (i) April 1, 2005 and (ii) the
first day of the calendar month immediately following the expiration of sixty
(60) days following the VLU Approval Date.
"Lockbox Account" shall mean the lockbox account into which all
payments in respect of the sale of the Products are to be remitted pursuant to
the terms of the Consent and Agreement.
"Marketing Plan" shall mean, with respect to each therapeutic
indication, the marketing plan developed and agreed to in writing by Agent and
Ortec for such indication in the Territory, as amended by the parties from time
to time, which plan shall include the following items: (i) market and situation
analysis, (ii) Strengths, Weaknesses, Opportunities, Threats (SWOT) Analysis,
(iii) promotional message, (iv) sales force requirements (e.g., number required
for adequate coverage, background requirements and required training), (v) core
promotional materials, (vi) symposium schedule, (vii) publication strategy, and
(viii) year-by-year budget for the various marketing activities.
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"Net Sales" shall mean the invoice price billed by or on behalf of
Agent to customers in the Territory on sales of Product, less the following
items: (i) discounts or rebates actually allowed in accordance with Section
6(d), (ii) Applicable Sales Tax and (iii) the actual cost of freight, insurance,
handling and transportation charges invoiced to a customer.
"New Custom Production Suite" shall mean a fully operational Custom
Production Suite (as defined in the Manufacturing Agreement) built at Agent's
facility after the Effective Date with a production capacity capable of
producing enough inventory of Product Units allowing for sales of the applicable
Total US Forecast Amount in each Target Year.
"Other Capacity Event" shall mean the occurrence or achievement of an
event or series of events (e.g., utilization of existing production capacity at
Agent's facility or development of significant process improvements) which
collectively results in the creation of production capacity at Agent's facility
capable of producing enough inventory of Product Units allowing for sales of the
applicable Total US Forecast Amount in each Target Year.
"Xxxx Royalty" shall mean Xxxx Royalty Fund, L.P. (formerly known as
Xxxx Capital Royalty Acquisition Fund, L.P).
"Xxxx Royalty Transaction Agreements" shall mean the (i) Amended and
Restated Revenue Interests Assignment Agreement, dated as of February 26, 2003,
among Orcel LLC, Ortec and Xxxx Royalty, (ii) Amended and Restated Security
Agreement, dated as of October 18, 2004, among Orcel, Ortec and Xxxx Royalty,
and (iii) Pledge Agreement, dated as of February 26, 2003, between Ortec and
Xxxx Royalty.
"Person" shall mean any individual, partnership, firm, corporation,
limited liability company, joint venture, association, trust or other entity or
any government or any governmental authority.
"Pro Rata Manufacturing Fee" shall mean, with respect to any Product
Unit for which Agent has not collected payment within the Allowed Collection
Period (as defined in Section 3(c)(ii)), an amount equal to the quotient of: (i)
the total amount invoiced to Ortec for services provided by Agent under the
Manufacturing Agreement during the calendar month in which such Product Unit was
manufactured and (ii) the total number of Product Units manufactured by Agent
under the Manufacturing Agreement during such calendar month.
"Product-Related Employee" shall mean any employee of Agent whose
business function (on a full- or part-time basis) involves the performance of
Agent's Marketing Efforts hereunder, including without limitation Product sales
representatives; provided, however, that order entry personnel shall not
constitute a Product-Related Employee.
"Product Trademark" shall mean the Orcel'r' trademark or such other
trademark as may be selected by Ortec for use on the Products and/or
accompanying logos, trade dress and/or indicia of origin owned by Ortec.
"Product Unit" shall mean a single patient dose or unit of Product.
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"Products" shall mean all existing and future bilayered cellular matrix
products (including, without limitation, Orcel'r' products), in either the fresh
or cryopreserved version, with respect to which Ortec or any Affiliate of Ortec
has the right to commercialize in the United States during the Term for the
treatment of VLU, DFU and for any other therapeutic indication for
dermatological chronic or acute wound healing or any other dermatological
application.
"Regulatory Approval" shall mean any approvals, licenses, registrations
or authorizations of the FDA, necessary for the commercialization of a Product
in the Territory.
"Target Year" shall mean each successive period of twelve (12)
consecutive months beginning on the Launch Date and each anniversary thereof
during the Term.
"Termination Fee" shall mean such payment due to Agent in the event
Ortec exercises its right to terminate this Agreement pursuant to Section
11(a)(7) hereto. The Termination Fee shall be equal to the difference between:
(A) the present value on the effective date of such termination (the
"Change in Control Termination Date") of all Commissions that Agent
shall have been entitled to throughout the remaining term of this
Agreement if this Agreement shall have expired on the Initial
Expiration Date and assuming that:
(i) the number of Product Units sold by Agent during such
period equals the greater of (1) the sum of the Total US
Forecast Amounts for each remaining year of the term of this
Agreement assuming the Agreement expires on the Initial
Expiration Date and (2) the product of (x) the number of
Product Units sold by Agent during the twelve month period
preceding the Change in Control Termination Date and (y) the
remaining term of this Agreement (in years) assuming this
Agreement expires on the Initial Expiration Date, and
(ii) the price of each Product Unit equals the lower of (x)
One Thousand One Hundred Dollars ($1100) and (y) the average
price of a Product Unit during the twelve month period
preceding the Change in Control Termination Date, and
(B) the present value on the Change in Control Termination Date of all
amounts required to have been spent by Agent hereunder in support of
Agent's Marketing Efforts between the Change in Control Termination
Date and the Initial Expiration Date (with the required expenditure
being prorated for any partial year). The discount rate to be applied
in determining present value for the purposes of this definition shall
be 10% per annum.
"Territory" shall mean the United States (including the Commonwealth of
Puerto Rico and other U.S. territories and possessions).
"Third Party" shall mean any Person other than Agent or Ortec or any of
their Affiliates.
"TRS Machine" shall mean the Thaw Rinse System machine (including any
second
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generation or improved versions thereof) developed by Ortec which is to be used
by health care professionals for the preparation of the Product Units for
clinical use.
"TRS Tray" shall mean the plastic tray (including any second generation
or improved versions thereof) developed by Ortec which is to be used by health
care professionals, in conjunction with a TRS Machine, for the preparation of
the Product Units for clinical use.
"Unrelated Products" shall mean all products sold by Agent other than
the Products.
2. REGULATORY APPROVALS. Ortec shall use all commercially reasonable
efforts to obtain Regulatory Approval of Orcel'r' for the treatment of venous
leg ulcers ("VLU") prior to January 1, 2005, and for diabetic foot ulcers
("DFU") prior to December 31, 2006. In addition, Ortec shall use best efforts to
provide Agent with a good faith estimate (and updates thereto) of the expected
Regulatory Approval date of Orcel'r' for the DFU indication (the "Expected DFU
Approval Date").
3. AGENCY; OBLIGATIONS OF AGENT AND ORTEC.
(a) Appointment of Agent. Ortec hereby appoints Agent as the exclusive
agent of Ortec in the Territory for (i) promoting the Products and (ii)
soliciting, taking and filling orders for the sale by Ortec of Products.
Accordingly, during the Term neither Ortec nor any Affiliate of Ortec will
directly solicit, take or fill orders for sales of Products in the Territory
(except through the agency established by this Agreement) or appoint any other
sales agent or representative to promote the Products in the Territory or
solicit, take or fill orders for sales by Ortec or any Affiliate of Ortec of
Products in the Territory.
(b) Agent Obligations.
(i) Agent is authorized and, during the Term will use
commercially reasonable efforts, on behalf of Ortec to solicit, take,
fill and collect payment for orders for the Products in the Territory
and to promote and market the Products in the Territory in accordance
with the applicable Marketing Plans (such activities, "Agent's
Marketing Efforts"); provided, however, that Agent shall be entitled to
allocate its efforts between sales of Products and sales of Unrelated
Products in a reasonable commercial manner consistent with maximizing
sales of Products in the Territory and with the applicable Marketing
Plan. Agent's obligations as Ortec's agent hereunder shall include
using commercially reasonable efforts to maintain appropriate Product
inventory availability levels, ship Products to fill orders, invoice
and collect from customers payments for the Products and remit such
collections to Ortec in accordance with Section 3(c). In addition,
Agent shall be responsible for developing a Marketing Plan for each new
Product indication to be marketed by Agent in the Territory under this
Agreement. Agent shall not in any manner condition sales of the
Products to any customer on such customer's purchase of Unrelated
Products sold by Agent and Agent shall not in any manner condition
sales of Unrelated Products to any customer on such customer's purchase
of the Products.
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(ii) In addition to Agent's obligations set forth in clause
(i) above, during the period (the "Initial VLU Marketing Period")
commencing on the Effective Date and ending on the sixteen month
anniversary of the date on which Orcel'r' receives Regulatory Approval
for the treatment of VLU ("VLU Approval Date"), Agent shall spend a
minimum of US$3,927,900 (representing $4,000,000 minus the aggregate
amount spent by Agent in support of Agent's Marketing Efforts for the
VLU indication prior to execution of this Agreement) (the "Initial VLU
Marketing Amount") in support of Agent's Marketing Efforts for the VLU
indication; provided, however, that, of the Initial VLU Marketing
Amount, Agent shall spend a minimum of US$927,900 (representing
$1,000,000 minus the aggregate amount spent by Agent in support of
Agent's Marketing Efforts for the VLU indication prior to execution of
this Agreement) during the period commencing on the Effective Date and
ending on the four month anniversary of the VLU Approval Date.
(iii) During the period commencing on the date that is six
months prior to the Expected DFU Approval Date and ending on the
eighteen month anniversary of the date on which Orcel'r' receives
Regulatory Approval for the treatment of DFU, Agent shall spend a
minimum of US$1,000,000 (the "Initial DFU Marketing Amount") in support
of Agent's Marketing Efforts for the DFU indication.
(iv) For each full Target Year following the expiration of the
Initial VLU Marketing Period, Agent shall spend a minimum amount equal
to (x) 95% of (y) the amount equal to 10% of the Target Revenue Amount
(as set forth in Exhibit B) applicable to such Target Year (the amount
represented by clause (y), the "Ongoing Marketing Amount"), in support
of Agent's Marketing Efforts for Product, provided that any amount
spent by Agent during any such Target Year in excess of 100% of the
applicable Ongoing Marketing Amount, which excess expenditure has been
approved in advance and in writing by Ortec (such approval not to be
unreasonably withheld or delayed), shall be counted and applied towards
the calculation of the Ongoing Marketing Amount for the immediately
following Target Year. For the full calendar months (in the aggregate)
following the expiration of the Initial VLU Marketing Period but prior
to the commencement of the immediately following new Target Year, Agent
shall spend a minimum amount equal to 95% of the product of (A) the
Ongoing Marketing Amount applicable to such current Target Year and (B)
the quotient of (i) the number of full calendar months remaining in
such current Target Year divided by (ii) twelve.
(v) The Initial VLU Marketing Amount, the Initial DFU
Marketing Amount and the Ongoing Marketing Amount shall include all
internal costs (which shall be Fully Burdened Costs) and all external
costs (i.e., consisting of payments to Third Parties), actually
incurred or accrued by or on behalf of Agent in support of Agent's
Marketing Efforts, including all costs related to the development of
the Marketing Plan for an indication, and in connection with the
provision of Reimbursement Support Services (as defined in Section 10).
Within thirty (30) days after the end of each six-month period of each
Target Year of the Term, Agent shall provide Ortec with a report
setting forth in reasonably sufficient detail Agent's calculation of
the Fully Burdened Costs incurred by Agent in support of Agent's
Marketing Efforts during the prior six-month period.
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(c) Invoicing and Collections. Subject to Section 2 of the Consent and
Agreement, Agent shall comply with the following provisions in connection with
invoicing customers and collecting payments from customers on behalf of Ortec
hereunder:
(i) Prior to the eighth business day of each month, Agent
shall pay to Ortec into the Lockbox Account the following amount in
respect of invoices issued to customers for Products:
(A) any amounts collected during the immediately preceding
calendar month from such customers (other than amounts already
paid to Ortec into the Lockbox Account pursuant to clause (ii)
below) on behalf of Ortec pursuant to such invoices (less
Commissions and Transaction Fees payable to Agent as provided
in Section 4 and which are attributable to such invoices),
minus
(B) any amounts invoiced, due and payable by Ortec to Agent
pursuant to the Manufacturing Agreement during the immediately
preceding calendar month for services and deliverables
provided by Agent thereunder, minus
(C) any amounts previously paid by Agent to Ortec pursuant to
this Section 3(c)(i) which are attributable to invoiced
Products subsequently returned by customers due to Product
being damaged as a result of a defect in or malfunction of a
TRS Machine or TRS Tray, minus
(D) any amounts previously paid by Agent to Ortec pursuant to
this Section 3(c)(i) which are attributable to invoiced
Products manufactured by a Person other than Agent and which
are subsequently returned by customers due to Product being
defective, minus
(E) Transaction Fees attributable to a shipment of Product to
a customer in replacement of Product returned by such customer
for the reasons described in clause (C) or (D) above, minus
(F) shipment fees reimbursed to, or paid for by Agent on
behalf of, a customer in connection with a return shipment of
Product to Agent for the reasons described in clause (C) or
(D) above;
provided, however, that clauses (C) and (D) shall only apply in cases
where a refund of the applicable invoiced amount is actually paid by
Agent to a customer. Agent shall use commercially reasonable efforts to
collect from customers payments of all invoices. Each such payment to
Ortec shall be accompanied by a statement reasonably detailing the
calculation of the Commissions and Transaction Fees deducted from such
payment.
(ii) Other than with respect to returned Products for the
reasons described in Section 3(c)(i)(C) or 3(c)(i)(D) above, Agent
shall retain the risk of collectibility of accounts receivable relating
to all Products sold under this Agreement. As such, with
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respect to any accounts receivable not collected by Agent within ninety
(90) days (the "Allowed Collection Period") after the applicable
invoice issuance date (excluding any Applicable Sales Tax portion of an
uncollected invoice, each, an "Overdue Invoice Amount"), Agent shall
pay to Ortec into the Lockbox Account, on or prior to the last business
day of the calendar month within which one hundred (100) days (the
"Overdue Payment Period") after the invoice issuance date falls, the
following amount (the "Section 3(c)(ii) Amount"): (A) the Overdue
Invoice Amount less (B) (x) any Commissions and Transaction Fees
payable to Agent as provided in Section 4 and which are attributable to
such Overdue Invoice Amount and (y) any Pro Rata Manufacturing Fees
attributable to such Overdue Invoice Amount, but only to the extent of
any overdue invoiced amounts payable by Ortec to Agent under the
Manufacturing Agreement, in which event the amount of such Pro Rata
Manufacturing Fees not paid into the Lockbox Account shall be deducted
from and applied to such overdue invoiced amounts payable by Ortec to
Agent. Prior to the end of the 1st Target Year, the parties shall
reconsider whether the duration of the Allowed Collection Period should
be increased, taking into consideration the average period of time (the
"Average Reimbursement Period") it takes for customers of Products in
the Territory to obtain reimbursement of the cost of Product from
third-party payors (e.g., Medicare). If the Average Reimbursement
Period, which shall be reasonably determined in good faith by Agent
based on a survey of customers in the Territory, exceeds seventy-five
(75) days, each of the Allowed Collection Period and the Overdue
Payment Period shall be increased by such excess number of days;
provided, however, that the Allowed Collection Period and the Overdue
Payment Period shall not exceed one hundred twenty (120) days and one
hundred fifty (130) days, respectively. In the event of the foregoing,
Agent shall provide Ortec with the results of such survey.
(iii) For purposes of this Agreement, Agent shall use the
following procedures in matching payments received from customers to
invoices relating to sales of Products hereunder: with respect to any
payment received from a customer, if more than one invoice is
outstanding with respect to such customer's account, Agent shall use
commercially reasonable efforts to match invoices to applicable
customer payments. If after such efforts Agent is unable to match any
payment to a particular invoice, Agent shall apply the "first-in,
first-out" principle in determining the invoice to which such payment
applies. One or more invoices issued on the same date shall be
aggregated and treated as a single invoice for purposes of this
paragraph.
(d) Reports. Within fifteen (15) days after the end of each month
during the Term, Agent shall provide Ortec with monthly reports relating to
Agent's Marketing Efforts and Product sales, invoices outstanding, collections,
inventories and other matters relevant to this Agreement in respect of such
month as Ortec shall reasonably request from time to time.
(e) Access to Information; Audit. Agent shall furnish or cause to be
furnished to a mutually agreeable independent certified public accountant
access, during normal business hours and upon reasonable prior notice, to such
information (including all relevant books and records of Agent) as reasonably
requested by Ortec to the extent such information relates to Agent's activities
under this Agreement. Furthermore, Ortec shall have the right (through such
accountant) to review and audit such information (including all relevant books
and records of
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Agent) to its satisfaction for purposes of determining Agent's compliance with
the terms of this Agreement. Such accountant shall be bound in confidence to
disclose only noncompliance with the terms of this Agreement. If Agent has
underpaid any amount due, or spent less than any minimum marketing expenditures
required to be spent, under this Agreement resulting in a cumulative discrepancy
of more than seven and one-half percent (7.5%), Agent shall reimburse Ortec for
the costs of such audit (with the cost of the audit to be paid by Ortec in all
other cases). If any examination or audit of the records described above
discloses an under- or over-payment of amounts due hereunder, the party owing
any money hereunder shall pay the same to the party entitled thereto within
thirty (30) days after receipt of the written results of such audit pursuant to
this clause (e). Ortec's right to audit under this clause (e) shall be
exercisable no more than once per calendar year during the Term and the one year
period following the end of the Term, in each case in respect of the current or
immediately preceding calendar year.
(f) Sales Tax. Agent shall comply with the following provisions in
connection with any Applicable Sales Tax that arises in connection with the sale
of Products pursuant to this Agreement. Subject to Section 2 of the Consent and
Agreement, on behalf of Ortec, Agent shall (i) collect Applicable Sales Tax on
behalf of Ortec from customers of Products; (ii) separately set forth any
Applicable Sales Tax on invoices issued to customers of Products; and (iii)
separately designate as "Sales Tax" any Applicable Sales Tax amounts remitted to
Ortec pursuant to Section 3(c). Ortec shall indemnify, hold harmless, and defend
Agent from any and all Losses (as defined below), including any interest or
penalties, with respect to sales taxes that arise in connection with the sale of
Products pursuant to this Agreement; provided, however, that Agent shall not be
entitled to any such indemnification or other action by Ortec with respect to
any portion of such Losses that arise as a result of the failure by Agent to
comply with the provisions of this Agreement or the Consent and Agreement. Ortec
shall be responsible for the timely payment of such sales taxes to the
appropriate governmental authorities and shall provide to Agent evidence that
such sales taxes were timely paid within five (5) days after the earlier of (x)
the date of each such payment and (y) the last date on which each such payment
shall be due and payable without interest or penalty.
4. COMMISSIONS; TRANSACTION FEE.
(a) Agent will be entitled to a commission on the Net Sales of each
separate order for Products (the "Commission"). The applicable Commission rate
shall be based on the cumulative aggregate amount of Product Units sold under
this Agreement, as follows:
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Cumulative Aggregate Product Units Sold Commission Rate (of Net Sales)
--------------------------------------------------------------------------------------
0 - 2000 Units 40%
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2001 - 14,500 Units 35%
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14,501 - 42,000 Units 30%
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Over 42,000 Units 27%
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Agent will be entitled to withhold the applicable Commission from amounts paid
by Agent to Ortec with respect to related customer invoices pursuant to Section
3(c).
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(b) In addition to Commissions, Agent will be entitled to a Transaction
Fee (as set forth in Exhibit D) per each separate order shipped by Agent for
Products under this Agreement in order to cover Agent's expenses in connection
with order processing, distribution, accounts receivable collection and
accounting. Agent will be entitled to withhold the applicable Transaction Fees
from amounts paid by Agent to Ortec with respect to related customer invoices
pursuant to Section 3(c).
5. TERM OF AGREEMENT. The term of this Agreement shall commence on the
Effective Date and shall continue until the date that is six (6) years after the
Launch Date (the "Initial Expiration Date"), unless terminated earlier pursuant
to Section 11 below (the "Term"). The Term shall be automatically extended
beyond the Initial Expiration Date for successive periods of one (1) year each
unless and until either Ortec or Agent gives the other written notice, at least
six (6) months prior to the Initial Expiration Date or any anniversary thereof
to which the Term has then been extended, that the notifying party has elected
not to extend the Term beyond the Initial Expiration Date or such anniversary
thereof to which the Term has then been extended, as the case may be.
6. PROMOTION; PRODUCT SUPPLY; THAW RINSE SYSTEM; PRICE.
(a) Promotion. Agent will use commercially reasonable efforts to market
and promote the Products in the Territory in accordance with the applicable
Marketing Plan.
(b) Source. During the Term, pursuant to, but except as provided in,
the Manufacturing Agreement, Agent shall be the exclusive source of Products for
all orders for Products solicited or received by Agent under this Agreement. At
any time during the Term in which Agent is not the exclusive source of Products
for the Territory, Ortec shall use its commercially reasonable efforts to timely
supply Agent with, or cause to have supplied to Agent, its requirements of
Products in connection with this Agreement consistent with maximizing sales of
Products in the Territory.
(c) TRS Machines; TRS Trays.
(i) Prior to November 30, 2004, Ortec shall ensure that a
minimum of forty (40) TRS Machines are available and ready for prompt
shipment to Agent. Ortec shall deliver to Agent that number of such TRS
Machines requested by Agent within seven (7) days of a delivery request
by Agent. Such TRS Machines shall be distributed by Agent for use by
customers of Products in the Territory. Prior to December 31, 2005, the
parties shall agree upon a commercially reasonable plan of distribution
with respect to the provision of additional TRS Machines to customers
in the Territory ("TRS Distribution Plan"), taking into consideration
the number of Product Units purchased by a customer and the cost of the
TRS Machines at such time. Ortec shall be responsible for manufacturing
and delivering to Agent TRS Machines pursuant to the TRS Distribution
Plan. In addition, Ortec shall provide to Agent the operating
instructions for the TRS Machines. Agent shall be responsible for
distributing the TRS Machines to customers in the Territory pursuant to
the TRS Distribution Plan. Ortec shall use all commercially
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reasonable efforts to manufacture (or cause to be manufactured), make
available and deliver to Agent enough TRS Machines in order to satisfy
customer demand and use of the Products in the Territory.
(ii) Prior to November 30, 2004, Ortec shall ensure that a
minimum of five hundred (500) TRS Trays are available and ready for
prompt shipment to Agent. Ortec shall deliver to Agent that number of
such TRS Trays requested by Agent within seven (7) days of a delivery
request by Agent. Such TRS Trays shall be distributed by Agent for use
by customers of Products in the Territory. Within sixty (60) days prior
to each calendar quarter, Agent shall place an order for the quantity
of TRS Trays Agent will need for distribution to customers during such
calendar quarter. Ortec shall ensure that the TRS Trays ordered by
Agent are available and ready for shipment to Agent within thirty (30)
days after such order is placed. Ortec shall deliver to Agent that
number of TRS Trays requested by Agent within seven (7) days of each
such delivery request (but, in no event, sooner than 30 days after the
original order for such TRS Trays is placed by Agent). Ortec shall use
all commercially reasonable efforts to manufacture (or cause to be
manufactured) and deliver to Agent enough TRS Trays in order to satisfy
customer demand and use of the Products in the Territory, taking into
the account the fact that the total number of TRS Tray units ordered by
Agent for distribution during any calendar quarter will likely exceed
the total number of Product Units sold in the Territory during such
calendar quarter by approximately ten percent of Product Unit sales.
(iii) Title to all TRS Machines shall remain with Ortec and
shall never vest in Agent or customer. Title to all TRS Trays shall
remain with Ortec until transferred to the ultimate customer and will
never vest in Agent. Risk of loss with respect to TRS Machines and TRS
Trays shall only vest and remain with Agent during those times in which
Agent has actual physical custody of such items. Ortec shall be solely
responsible for all costs and expenses in connection with the
manufacture and delivery (including shipping costs) of TRS Machines and
TRS Trays under this Section 6(c).
(d) Price; Price Changes. Ortec shall retain final decision-making
authority with respect to establishing prices for the Products; provided,
however, that Ortec shall consult with Agent in the establishment of such prices
in the Territory and prior to (but not less than ten business days) making any
changes thereto. Agent shall quote and offer prices for the Products to
customers on Ortec's behalf in accordance with the prices established by Ortec,
provided that Agent may offer commercially reasonable discounts or rebates to
customers in the Territory in accordance with such guidelines as may be
negotiated, in good faith, and agreed upon (in writing) from time to time by
Ortec and Agent during the Term (it being understood and agreed that, other than
negotiating such discount guidelines in good faith with Agent, Ortec shall have
no obligation to consent to the allowance of discounts or rebates).
7. TITLE. In accordance with the Manufacturing Agreement, after
delivery by Agent to the carrier for shipment, title and risk of loss with
respect to Products shall pass to and remain with Ortec until transferred to the
ultimate customer and will never vest in Agent thereafter.
11
8. ADVERSE EVENT REPORTING.
(a) Agent shall establish and maintain a system for the receipt,
recording and maintenance of Adverse Event information with respect to the
Products during regular business hours, which shall comply with all applicable
FDA regulations. Agent shall promptly notify the pharmacovigilance
representative of Ortec designated pursuant to Section 8(c) of all Adverse
Events concerning a Product reported to its personnel. Ortec and Agent shall
prepare an Adverse Event reporting form that may be used by the Agent as a basis
for such reports. Agent shall promptly notify Ortec of any complaint received by
Agent in sufficient detail and in sufficient time to allow Ortec to comply with
Adverse Event regulatory requirements imposed upon Ortec with respect to the
Products in the Territory. Ortec shall promptly advise Agent of any regulatory
developments (e.g., proposed recalls, labeling and other registrational dossier
changes, etc.) affecting the Products in the Territory.
(b) Ortec shall have sole responsibility for notifying the FDA of any
Adverse Events relating to a Product. Agent shall assist Ortec by promptly
obtaining such follow-up information to the initial report from the reporter as
Ortec may reasonably request. Ortec shall hold the master safety database for a
Product.
(c) All Adverse Event information to be reported to Ortec under this
Section 8 shall be reported as follows:
Ortec International, Inc.
0000 Xxxxxxxx
Xxx Xxxx, XX 00000
Attention: Xxxxxx Xxxxxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
E-Mail: xxxxx.xxxxxxx@xxxxxxxxxxxxxxxxxx.xxx
or to such other address, contact person, telephone number, facsimile number or
e-mail address as may be specified by Ortec in writing to Agent.
(d) Ortec shall be responsible for making all determinations as to how
Adverse Events concerning a Product will be reported to the FDA.
9. PRODUCT TRADEMARK; PROMOTIONAL MATERIALS. The Products shall be
promoted and sold in the Territory under the Product Trademark. During the Term,
Ortec hereby grants to Agent a royalty-free license to use the Product Trademark
for the purposes of Agent's promotional activities pursuant to this Agreement
and subject to the terms and conditions of this Agreement. Agent shall utilize
the Product Trademark only in the format(s) approved by Ortec. The parties agree
that Agent shall own all right, title and interest in and to all trade dress,
logos and promotional materials created by, for or under Agent's direction in
connection with this Agreement, including all intellectual property rights
associated therewith (in each case, other than the Product Trademark)
(collectively, the "Promotional Materials"). In the event that Ortec notifies
Agent of its desire to license or acquire all or a portion of such Promotional
Materials from Agent, Ortec and Agent shall negotiate the terms and conditions
of such license or acquisition, as applicable, in good faith; provided, however,
that if the parties
12
cannot agree upon a royalty rate or purchase price, as applicable, within a
reasonable amount of time (but no sooner than sixty days after commencement of
negotiations), such royalty rate or purchase price shall be determined by an
independent third party investment bank, or accounting or consulting firm,
mutually agreed upon by the parties, which entity shall have experience in
valuing intellectual property rights.
10. REIMBURSEMENT SUPPORT. During the Term, Agent shall provide
reasonable reimbursement (i.e., third-party payment for medical products)
support services to customers of Products in the Territory ("Reimbursement
Support Services"), including reasonable monitoring of customers' claims for
reimbursement.
11. TERMINATION.
(a) This Agreement may be terminated as follows:
(1) In the event of a material breach of this
Agreement by either party, the other party shall have the
right to deliver a written notice of default to the defaulting
party (a "Default Notice"). In the event any such breach is
not cured within 90 days after service of the Default Notice,
this Agreement shall terminate if the non-defaulting party
delivers a written notice of termination to the defaulting
party within 180 days after the expiration of such 90-day cure
period. The parties agree that the failure of Agent to meet
the minimum spending amounts in accordance with clause (ii),
(iii) or (iv) of Section 3(b) shall be deemed a material
breach of this Agreement, provided that Agent shall have the
opportunity to cure any such breach in accordance with this
Section 11(a)(1). If the Manufacturing Agreement is terminated
for any reason and Agent is no longer the supplier of the
Products for the Territory, in no event shall Agent be deemed
to be in breach of this Agreement nor shall Ortec have the
right to terminate under Section 11(a)(2), if such breach or
failure of Agent to meet certain performance obligations
(including, without limitation, Agent's obligations to meet
certain Minimum Sales Target Amounts under Section 11(a)(2))
is primarily the result of or otherwise attributable to
Agent's inability to timely obtain its requirements of Product
from any subsequent supplier of Product and/or Ortec in
connection with its performance under this Agreement.
(2) By Ortec after the twelve (12) month anniversary
of the Effective Date and anytime thereafter, upon six (6)
month's prior written notice to Agent (which notice may not be
sent prior to such twelve month anniversary), if the aggregate
sales of Product Units under this Agreement attributable to
each of the 1st, 2nd, 3rd, 4th, 5th and 6th Target Years (and,
if applicable, each New Target Year (as defined in Exhibit A))
do not exceed the Minimum Sales Target Amount set forth in
Exhibit A with respect to each such Target Year or New Target
Year; provided, however, that (i) in the event that Agent
fails to meet the applicable Minimum Sales Target Amount for
such a Target Year or New Target Year, Ortec may only exercise
its right to terminate this Agreement under this clause (2)
prior to the expiration of the sixty (60) day period following
end of the applicable
13
Target Year or New Target Year (e.g., if the 2nd Target Year
expires on March 31, 2007 and Agent fails to meet the Minimum
Sales Target Amount for such Target Year, Ortec must exercise
its termination right, if at all, prior to or on May 30,
2007), except that, if Ortec does not timely receive the sales
report described in Section 3(d) in respect of sales for the
last month of such Target Year or any other monthly sales
report due hereunder by the end of such Target Year, such
60-day period shall be extended by one day for each day that
such sales report is late, and (ii) Ortec shall have no right
to terminate this Agreement under this clause (2) if Agent's
failure to meet the applicable Minimum Sales Target Amount is
primarily due to (x) the unavailability of enough Product
Units to Agent, either from Agent's own production under the
Manufacturing Agreement or from third party manufacturing
sources arranged by Ortec, provided that this clause (x) shall
have no effect (i.e., Ortec shall once again have the right to
terminate this Agreement under and in accordance with this
clause (2)) in respect of the first full Target Year following
the expiration of the six-month period after the completion of
a New Custom Production Suite or the occurrence of an Other
Capacity Event, whichever is earlier, and each Target Year
thereafter, (y) a Force Majeure on the part of Agent or the
suspension of Ortec's license or authority to commercialize
Orcel'r' for the VLU or DFU indication in the Territory, or
(z) Ortec's failure to make available to Agent enough TRS
Machines in accordance with the TRS Distribution Plan and/or
TRS Trays for the TRS Machines already delivered in order to
satisfy customer demand and use of the Products in the
Territory, except when such failure on the part of Ortec is
due primarily to the failure of Agent to accurately and timely
forecast such demand.
(3) By Agent, upon six (6) month's prior written
notice to Ortec, if the average of the monthly sales of
Product Units under this Agreement attributable to any
consecutive six-month period during the Term, commencing with
the period starting on January 1, 2007, does not equal or
exceed 1500 Product Units (such an event, a "Section 11(a)(3)
Termination Event"). For the avoidance of doubt, the average
of monthly sales for any six-month period shall be calculated
by dividing the sum of all Product Units sold by Agent during
the applicable six-month period by six; provided, however,
that in the event a Section 11(a)(3) Termination Event occurs,
Agent may only exercise its right to terminate this Agreement
under this clause (3) within 45 days following the expiration
of the applicable six-month period.
(4) By either party, by written notice to the other
party, if the other party shall (i) voluntarily commence any
proceeding or file any petition seeking relief under Title 11
of the United States Code or any other Federal, state
bankruptcy, insolvency, liquidation, receivership or similar
law (a "Bankruptcy Law"), (ii) consent to the institution of,
or fail to contravene in a timely and appropriate manner, any
such proceeding or the filing of any such petition, (iii)
apply for or consent to the appointment of a receiver,
trustee, custodian, sequestrator or similar official for such
party or for a substantial part of its property or assets,
(iv) file an answer admitting the material allegations of a
petition filed against it in any such
14
proceeding, (v) make a general assignment for the benefit of
creditors, (vi) take corporate action for the purpose of
effecting any of the foregoing or (vii) be subject to the
commencement of any involuntary proceeding or the filing of
any involuntary petition in a court of competent jurisdiction
seeking (A) relief in respect of such party or of a
substantial part of its property or assets under any
Bankruptcy Law, (B) the appointment of a receiver, trustee,
custodian, sequestrator or similar official for such party or
for a substantial part of its property or assets or (C) the
winding-up or liquidation of such party; and in the case of
this clause (vii) such proceeding or petition shall continue
undismissed for 120 days or an order or decree approving or
ordering any of the foregoing shall continue unstayed and in
effect for 60 days.
(5) By Agent, by written notice to Ortec, if Ortec
has not received Regulatory Approval for Orcel'r' for the VLU
indication prior to or on April 1, 2005.
(6) By Agent, by written notice to Ortec, if Ortec's
license or authority to commercialize Orcel'r' in the
Territory is (i) suspended by the FDA for a period in excess
of ninety (90) consecutive days or (ii) rescinded by the FDA,
in each case other than due to a cause for which Agent is
solely responsible and at fault.
(7) By either party, upon the occurrence of a Change
in Control of Ortec; provided, however, that (i) the
terminating party shall provide the other party with at least
six month's prior written notice of termination pursuant to
this provision, (ii) if Ortec terminates this Agreement
pursuant to this provision, Ortec shall pay to Agent the
Termination Fee by wire transfer to an account designated by
Agent prior to the effective date of such termination, and
(iii) Agent may only terminate this Agreement pursuant to this
provision if Agent reasonably determines that (x) the
acquiring entity or successor to Ortec, as the case may be, is
a direct or indirect competitor of Agent or any of its
Affiliates or (y) such Change of Control of Ortec has or may
otherwise have an adverse financial impact on Agent's and/or
its Affiliates' business or operations.
(b) Upon the termination of this Agreement for any reason, the parties
shall cooperate to effect the transfer to Ortec or Ortec's designee of the
responsibilities of Agent hereunder (including, without limitation, the transfer
by Agent to Ortec or Ortec's designee of inventories of Products and accounts
receivable).
(c) Upon termination of this Agreement for any reason, Agent shall
promptly provide Ortec with originals or copies of all account and business
information, including, without limitation, (i) customer lists, (ii) account
records, (iii) account balances, (iv) current inventory levels and (v) other
records or information, in each case to the extent relating to the business
conducted under this Agreement, that Ortec may reasonably request.
(d) Remedies for breach, obligations to make payments (for Products
shipped prior to termination) and Sections 13 through 25 shall survive
termination.
15
12. ASSIGNMENT. This Agreement and the rights and obligations hereunder
shall not be assignable or transferable, directly or indirectly, by Ortec or
Agent without the prior written consent of the other party (which may not be
unreasonably withheld or delayed), except (i) to an Affiliate of a party so long
as such Affiliate agrees in writing to be bound by the terms of this Agreement
or (ii) in connection with a Change in Control. The assigning party shall remain
primarily liable hereunder notwithstanding any such assignment. Any attempted
assignment in violation hereof shall be void.
13. NOTICES. All notices and other communications hereunder shall be in
writing and shall be deemed given when delivered personally or sent by prepaid
telex, cable or telecopy, or sent, postage prepaid, by registered, certified or
express mail (return receipt requested) or reputable overnight courier service
and shall be deemed given when so delivered by hand, telexed, cabled or
telecopied, or if mailed, three days after mailing (two business days in the
case of express mail or overnight courier service) to the parties at the
following addresses (or at such other address for a party as shall be specified
by like notice):
(i) if to Agent,
Cambrex Bio Science Walkersville, Inc.
0000 Xxxxx Xxxx Xxxx
Xxxxxxxxxxxx, Xxxxxxxx 00000
Fax: (000) 000-0000
Attention: N. Xxxxx Xxxxxx, President of BioProducts
Strategic Business Unit
with a copy to:
Cambrex Corporation
Xxx Xxxxxxxxxxx Xxxxx
Xxxx Xxxxxxxxxx, Xxx Xxxxxx 00000
Fax: (000) 000-0000
Attention: Xxxxx X. Xxxxxx, General Counsel
(ii) if to Ortec,
Ortec International, Inc.
0000 Xxxxxxxx
Xxx Xxxx, XX 00000
Fax: (000) 000-0000
Attention: Xxx Xxxxxxxx, Vice Chairman & CEO
with a copy to:
Xxxxx Xxxxxxxxx Xxxxxxxx Xxxxx Xxxxx Bass & Rhine, LLP
000 Xxxxxxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
16
Fax: (000) 000-0000
Attention: Xxxxxxx Xxxxxxxxx, Esq.
14. REPRESENTATIONS AND WARRANTIES; COVENANTS.
(a) Due Organization, Valid Existence and Due Authorization. Each party
hereby represents and warrants to the other party, as of the date hereof, as
follows: (a) Such party (i) is duly organized and validly existing under the
laws of its place of incorporation or organization; (ii) has full corporate
power and authority and has taken all corporate action necessary to enter into
and perform this Agreement; (b) the execution and performance by such party of
its obligations under this Agreement does not constitute a breach of, or
conflict with, its organizational documents or any material agreement or
arrangement, whether written or oral, by which it is bound; and (c) this
Agreement is its legal, valid and binding obligation, enforceable in accordance
with the terms and conditions hereof (subject to bankruptcy, insolvency,
reorganization, moratorium, fraudulent transfer or other laws (whether
statutory, regulatory or decisional), now or hereafter in effect, relating to or
affecting the rights of creditors generally or by equitable principles
(regardless of whether considered in a proceeding at law or in equity)).
(b) Consents. Each party hereby represents and warrants to the other
party, as of the date hereof, that all necessary consents, approvals and
authorizations of all governmental authorities and other third parties required
to be obtained by such party in connection with the execution, delivery and
performance of this Agreement have been obtained.
(c) Compliance with Law. Each party shall comply with all applicable
laws and regulations (including FDA regulations) in the discharge of its
obligations as set forth in this Agreement.
(d) Product Claims. Neither party shall make any medical or promotional
claim for the Product beyond the scope of the relevant Regulatory Approval(s)
then in effect for the Product.
(e) Intellectual Property. Ortec hereby represents and warrants that
(i) the use of the Product Trademark in the Territory will not infringe a
trademark of a Third Party, and (ii) subject only to Xxxx Royalty's rights under
the Xxxx Royalty Transaction Agreements as such agreements exist on the date
hereof, Ortec has, and will have throughout the remainder of the Term, all
right, power and authority to commercialize the Products in the Territory, and
neither Ortec nor any of its Affiliates is aware of any rights of any Person
that have been or will or may be infringed by the commercialization of the
Products in the Territory. Neither Ortec nor any of its Affiliates has notice
that any Person has claimed that the use or sale in the Territory of the
Products infringes rights of any Person.
15. INDEMNIFICATION.
(a) Ortec shall indemnify, hold harmless, and defend Agent from any and
all liability, loss, claims, lawsuits, damages, injury, settlements, costs and
expenses whatsoever (as incurred), including but not limited to court costs and
reasonable attorneys' fees (collectively, the
17
"Losses"), arising out of or related to (i) the Products or the use thereof or
(to the extent relevant to infringement, product liability or similar claims)
distribution thereof, except to the extent such Losses result from a breach by
Agent of the Product Warranties (as defined in Manufacturing Agreement), (ii)
the TRS Machines and TRS Trays, or the use thereof, (iii) any breach by Ortec of
any representation, term, covenant or condition contained in this Agreement or
(iv) any gross negligence or willful misconduct by Ortec in the performance of
its obligations under this Agreement.
(b) Agent shall indemnify, hold harmless, and defend Ortec from any and
all Losses arising out of or related to (i) any breach by Agent of any
representation, term, covenant or condition contained in this Agreement or (ii)
any gross negligence or willful misconduct by Agent in the performance of its
obligations under this Agreement.
16. LIMITATION OF DAMAGES. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR
SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT
LIMITATION, LOSS OF PROFITS) SUFFERED BY ANY OTHER PARTY, EXCEPT TO THE EXTENT
OF ANY SUCH DAMAGES PAID TO A THIRD PARTY AS PART OF A THIRD-PARTY CLAIM.
17. NON-COMPETITION. During the Term, Agent shall not sell or
distribute, on behalf of itself or any Third Party, any Competitive Product.
18. NON-SOLICITATION. Each party agrees not to employ or solicit for
employment (or for use as an independent contractor), any employee of the other
party or its Affiliates during the Term and for a period of two years
thereafter, except with such other party's prior written consent; provided,
however, that, during the six-month period following the termination of this
Agreement, Ortec shall have the right to offer employment to those sales
representatives/agents employed by Agent who are responsible for marketing the
Product and who are not involved in the marketing of any other product on behalf
of Agent.
19. NO THIRD PARTY BENEFICIARY. None of the provisions herein contained
are intended by the parties, nor shall they be deemed, to confer any benefit on
any Person not a party to this Agreement.
20. GOVERNING LAW. This Agreement shall be construed and governed by
the laws of the State of New York without regard to the conflicts provisions
thereof.
21. NO PARTNERSHIP RELATION. The parties hereto intend that no
partnership, joint venture or similar relationship be created pursuant to this
Agreement.
22. NONWAIVER. Waiver by a party of a breach hereunder by the other
party shall not be construed as a waiver of any succeeding breach of the same or
any other provision. No delay or omission by a party in exercising or availing
itself of any right, power or privilege hereunder shall preclude the later
exercise of any such right, power or privilege by such party. No waiver shall be
effective unless made in writing with specific reference to the relevant
provision(s) of this Agreement and signed by a duly authorized representative of
the party
18
granting the waiver.
23. ADDITIONAL DOCUMENTS. Each of the parties hereto agrees to execute
any document or documents that may be reasonably requested from time to time by
the other party to implement or complete such party's rights or obligations
pursuant to this Agreement.
24. ENTIRE AGREEMENT; MODIFICATION; SEVERABILITY. Other than the
Manufacturing Agreement and the Consent and Agreement, there are no other
agreements or understandings, written or oral, between the parties, regarding
this Agreement. This Agreement shall not be modified or amended except by a
written document executed by both parties to this Agreement, and such written
modifications shall be attached to this Agreement. If any term or other
provision of this Agreement is invalid, illegal or incapable of being enforced
by any law or public policy, all other terms and provisions of this Agreement
shall nevertheless remain in full force and effect so long as the economic or
legal substance of the transactions hereby is not affected in any manner
materially adverse to either party. The parties shall endeavor in good-faith
negotiations to replace the invalid, illegal or unenforceable provisions with
valid provisions the economic effect of which between the parties comes as close
as possible to that of the invalid, illegal or unenforceable provisions.
25. AUTHORIZATION. The persons executing this Agreement have due power
and authority to so execute this Agreement.
26. SECTION HEADINGS. The section headings set forth herein are for
purposes of convenience only, and shall have no bearing whatsoever on the actual
content of this Agreement.
27. COUNTERPARTS. This Agreement may be executed in counterparts, each
of which shall be deemed to be an original, and all of such counterparts shall
together constitute one and the same agreement.
28. FORCE MAJEURE. In the event of strikes, lock-outs or other
industrial disturbances, rebellions, mutinies, epidemics, landslides, lightning,
earthquakes, fires, hurricanes or other storms, floods, sinking, drought, civil
disturbances, explosions, acts or decisions of duly constituted municipal, state
or national governmental authorities or of courts of law, as well as
impossibility to obtain equipment, supplies, fuel or other required materials,
in spite of having acted with reasonable diligence, or by reason of any other
causes which are not under the control of the party requesting the abatement of
performance, or causes due to unexpected circumstances which are not possible to
eliminate or overcome with due diligence by such party ("Force Majeure"), the
parties agree that, if either Agent or Ortec finds itself wholly or partially
unable to fulfill its respective obligations under this Agreement by reasons of
Force Majeure, the party affected shall advise such other party in writing of
its inability to perform, giving a detailed explanation of the occurrence of the
event which excuses performance as soon as possible after the cause or event has
occurred. If such notice is given, the performance of the party giving the
notification shall be abated, and any time deadlines shall be extended for so
long as performance may be prevented by Force Majeure; provided, however, that
in the event the suspension of performance continues for more than ninety (90)
days after the date of the occurrence of such
19
Force Majeure, and such failure to perform would constitute a material breach of
this Agreement in the absence of such Force Majeure, the nonaffected party may
terminate this Agreement immediately by written notice to the other party. No
party shall be required to make up any performance that was prevented by Force
Majeure.
29. XXXXXXXX-XXXXX COMPLIANCE. During the Term, each party shall
reasonably cooperate with the other party (the "Complying Party') in order for
the Complying Party to satisfy its obligations under Sections 302 and 906 of the
Xxxxxxxx-Xxxxx Act of 2002 and any rules and regulations thereto, in each case
to the extent such cooperation is related to the transactions contemplated by
this Agreement.
20
IN WITNESS THEREOF, the parties hereto have caused this Agreement to be
executed on the day and year first written above.
CAMBREX BIO SCIENCE WALKERSVILLE, INC.
By: /s/ Xxxxx Xxxxxx
-----------------------------
Title: President, BioProducts
Name: N. Xxxxx Xxxxxx
ORTEC INTERNATIONAL, INC.
By: /s/ Xxx Xxxxxxxx
-----------------------------
Title: Chief Executive Officer/Vice Chairman
Name: Xxx Xxxxxxxx
21
EXHIBIT A
MINIMUM SALES TARGET AMOUNTS
The Minimum Sales Target Amount for each Target Year shall equal 75% of the
Total US Forecast Amount (as defined below):
"Total US Forecast Amount" with respect to each Target Year is defined
as:
1st Target Year: 10,000 Product Units
2nd Target Year: 25,000 Product Units
3rd Target Year: 40,000 Product Units
4th Target Year: 60,000 Product Units
5th Target Year: 80,000 Product Units
6th Target Year: 100,000 Product Units
Notwithstanding the foregoing, in the event that (i) Ortec does not receive
Regulatory Approval of Orcel'r' for the VLU indication prior to or on Xxxxx 00,
0000, (xx) Ortec does not receive Regulatory Approval of Orcel'r' for the DFU
indication by July 1, 2007, (iii) the FDA approved label for the Product
incorporates commercially significant restrictions that could significantly
restrict usage of the Product or the patient population, or (iv) Ortec does not
pay to Agent the Construction Fee (as defined in the Manufacturing Agreement)
when such fee becomes due and payable under the Manufacturing Agreement, the
Minimum Sales Target Amounts set forth above for the Target Years shall no
longer apply, and Ortec and Agent shall renegotiate in good faith and promptly
agree upon a new Minimum Sales Target Amount for each such Target Year.
If this Agreement has not been terminated prior to the end of the ninth month of
the 6th Target Year or of each succeeding Target Year thereafter, and is
expected to remain in effect during the Target Year following each such year
(starting with the 7th Target Year, each a "New Target Year"), the parties shall
promptly negotiate in good faith and agree upon a Minimum Sales Target Amount
for each New Target Year, taking into account the then most recent sales and
forecast information available to the parties; provided, however, that the
Minimum Sales Target Amount for each New Target Year shall not be less than
75,000 Product Units.
22
EXHIBIT B
TARGET REVENUE AMOUNT
"Target Revenue Amount" with respect to each applicable Target Year is defined
as the amount equal to 75% of the product of (i) the Total US Forecast Amount
for such Target Year and (ii) the lower of (x) One Thousand One Hundred Dollars
($1100) and (y) the average price of a Product Unit during the prior Target
Year.
EXHIBIT C
FULLY BURDENED COSTS
Fully Burdened Cost will be unique for each Product-Related Employee but may
include the following:
o Base Salary
o Bonus/Commission
o Benefits
o Charged as a Fixed Percentage of Base + Bonus/Commission
o Fixed Percentage set by Agent's ultimate parent entity and
adjusted on an annual basis
o For 2004 the Fixed Percentage is 35%
o Travel and Entertainment
o Human Resources support - $4,000 per Product-Related Employee
o Training
o Office Supplies
o Telephone
o Auto
* Fully Burdened Costs shall be prorated for any Product-Related Employee who
allocates his/her time between sales of Products and sales of Unrelated
Products.
EXHIBIT D
TRANSACTION FEE
The Transaction Fee amount applicable to an order of Products shall be
calculated based upon the (i) the size (i.e., small box or large box) and (ii)
number of boxes required for shipment of an order. A small box holds 1 to 3
Product Units. A large box holds 4 to 10 Product Units.
The Transaction Fee associated with each box type is as follows:
----------------------------------------------------------------------------------------------------
Small Box Large Box
----------------------------------------------------------------------------------------------------
Raw Materials (Box, Dry Ice, etc) $ 22.91 $ 32.34
----------------------------------------------------------------------------------------------------
Freight $ 30.25 $ 43.89
----------------------------------------------------------------------------------------------------
Labor $ 25.98 $ 25.98
----------------------------------------------------------------------------------------------------
Total $ 79.14 $ 102.21
----------------------------------------------------------------------------------------------------
Example: If a customer submits an order for 12 Product Units, the Transaction
Fee applicable to such order shall equal $181.35. The calculation is as follows:
$79.14 (Small Box containing 2 Product Units)
+ $102.21 (Large Box containing 10 Product Units)
-------------------------------------------------
$181.35 (Total Transaction Fee/Order)
* The parties acknowledge and agree that Agent has had no participation or
involvement in the design of the Product package or the shipping/stability
studies conducted with respect to such packaging. In addition, the parties
acknowledge and agree that the Transaction Fee has been determined based upon
information provided to Agent by Ortec relating to dry ice requirements and
stability. In the event that such information is incorrect, the Transaction Fee
shall be promptly adjusted in accordance with the following paragraph.
** On a quarterly basis during the first year after Regulatory Approval of the
VLU indication and on an annual basis thereafter, Agent shall evaluate the
actual costs of raw materials, freight and labor associated with order
entry/processing and distribution (including obtaining Product Units from
inventory, packaging, labeling and shipment) of Products hereunder. The
Transaction Fee shall be adjusted upwards or downwards in order to take into
account any increase or decrease, respectively, of such actual costs (in the
aggregate). Agent shall provide Ortec with written notice of any such
adjustments at least 30 days prior to implementation thereof, together with
reasonable data supporting any such increase or decrease.
