This Agreement
(“Agreement”) is entered into as of the last date
executed below (the “Effective Date”) and is by and
among BioMimetic Therapeutics, Inc. having its principal
office located at 389 Nichol Mill Lane, Franklin, TN 37067 USA
(“Manufacturer”), and Joint Solutions Alliance
Corporation having its principal office located at 975 Fraser
Drive, Unit 18, Burlington, ON L7L 4X8 Canada
(“Distributor”)(each, individually a
“Party” and collectively the
“Parties”).
WHEREAS
Manufacturer is engaged in the business of manufacturing bio-active
drug-device combination products for the healing of musculoskeletal
injuries and disease, including orthopedic, spine and sports injury
applications, including the Products (as hereinafter defined);
and
WHEREAS
Distributor is engaged in the business of selling and marketing
goods manufactured by others in the Territory (as hereinafter
defined), including products similar or related to the Products;
and
WHEREAS
Distributor is desirous of being appointed an exclusive distributor
of the Products in the Territory.
NOW THEREFORE, In
consideration of the mutual covenants and agreements herein
contained, Manufacturer and Distributor do hereby agree as
follows:
1.01. Approval
Date. The term “Approval Date” shall mean the date
that Manufacturer is granted marketing authorization within the
Territory to market and sell the Products.
1.02.
Products. The term “Products” shall include the
products listed in EXHIBIT A. Manufacturer shall have the right to
modify, alter, improve, change, add to or discontinue any or all
the Products, but Manufacturer shall only discontinue a Product
upon ** days’ prior written notice to Distributor.
1.03.
Specifications. The term “Specification” as to any
Product shall refer to the specifications set forth for such
product in EXHIBIT A.
1.04.
Territory. The term “Territory” shall include the
country of Canada.
1.05.
Field. The term “Field” shall include Products for
treating indications within or below the neck in humans, and shall
expressly exclude all veterinary applications.
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REPRESENTS
MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES
ACT OF 1933, AS AMENDED.
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2. Exclusive
Distributorship.
2.01. Grant of
Distributorship. Manufacturer hereby grants to Distributor the
exclusive right to sell the Products within the Field during the
Term (as hereinafter defined) to customers located within the
Territory for delivery in the Territory all in accordance with the terms and conditions
set forth herein and subject to the Sales Restriction set forth
below. Distributor is not authorized to sell the Products for
delivery outside the Territory or outside the Field unless
Distributor has received the prior written consent of
Manufacturer.
2.02. Sales
Restriction. Distributor shall only be permitted to market and
sell Products (directly or indirectly) to customers who do not have
a valid dental or veterinary license (“Sales
Restriction”). Manufacturer may terminate this Agreement with
cause upon ** days notice if Distributor violates this Sales
Restriction, provided that Distributor fails to cure such breach
within such ** day notice period. Notwithstanding the foregoing,
Manufacturer may terminate this Agreement with cause ** if
Distributor or Distributor’s subdistributor or subdealer
violates the Sales Restriction ** times within any ** period.
Distributor shall indemnify Manufacturer for ** that they may be
required to pay as a result of Distributor’s or any of its
subdistributor’s or subdealer’s violation of the Sales
Restriction.
3. Orders
and Performance.
3.01. Rolling
Forecasts . Upon a mutually agreed upon date upon the
anticipation of the Approval Date, Distributor will provide to
Manufacturer an initial forecast of its requirements for the
Products during each of the six (6) calendar quarters
beginning with the anticipated Approval Date. On the first day of
the third month of each calendar quarter thereafter during the term
of this Agreement, Distributor shall update the forecasted
requirements for each of the calendar quarters covered by the
previous forecast and shall include forecasted requirements for an
additional calendar quarter. Each forecast provided in accordance
herewith shall specify the number of units of the Products required
by Distributor in each covered calendar quarter by month in the
form set forth in EXHIBIT B. The requirements for the first two
quarters covered by each forecast shall be binding. Distributor
shall be obligated to purchase and pay for one hundred percent
(100%) of the forecasted requirements for such binding calendar
quarters, whether or not Distributor issues purchase orders for the
forecasted amounts of the Products in accordance with
Section 3.02.
3.02. Purchase
Orders . A minimum of ** days prior to Distributor’s
requested shipment date for any order of the Products, Distributor
shall submit a purchase order to Manufacturer specifying the number
of units of Products to which the order relates, the address to
which the order should be shipped, and the requested delivery date.
No purchase order shall be binding on Manufacturer unless such
purchase order conforms to the terms of this Agreement and is
acknowledged and accepted in writing by Manufacturer. Manufacturer
will use commercially reasonable efforts to fill any purchase order
for quantities of the Products that exceed the forecasted
requirements for the month in which delivery is requested as
promptly as
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**
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REPRESENTS
MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES
ACT OF 1933, AS AMENDED.
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practicable,
but Manufacturer cannot guarantee that it will be able to fill any
such order by the requested delivery date.
3.03. Terms of
Delivery and Shipment. The terms and conditions of sale shall
be those set forth in EXHIBIT D, as modified or supplemented by
additional terms of this Agreement. The terms set forth in this
Agreement and in EXHIBIT D shall prevail over any inconsistent
or additional terms set forth in Distributor’s purchase
order. The Products sold to Distributor by Manufacturer shall be
shipped ** from the Manufacturer’s manufacturing facility for
the Products **, to the destination in the Territory designated by
Distributor in the purchase order, unless otherwise agreed by the
Parties. Title to the Products shall transfer from the Manufacturer
to the Distributor upon delivery to ** at the **. Distributor shall
pay all ** associated with shipment, export or import of the
Products.
3.04. Annual
Sales Quota . If the Approval Date occurs within the first
three (3) quarters of the year, within ** days of the Approval
Date, Manufacturer and Distributor shall agree upon a sales quota
for the Distributor for the then current calendar year. If the
Approval Date occurs within the last quarter of the year, within **
days of the Approval Date, Manufacturer and Distributor shall agree
upon a sales quota for the Distributor that shall apply from the
Approval Date through the end of the calendar year following the
Approval Date. Thereafter, on or before ** of each year,
Manufacturer and Distributor shall agree upon a sales quota for the
Distributor for the following calendar year. If the Parties are
unable to agree upon a sales quota or **. If Distributor fails to
achieve ** of its sales quota during any given year, Manufacturer
shall have the right, at its sole discretion, to either:
(1) terminate this Agreement at anytime thereafter upon **
days notice; (2) **; or (3) **.
3.05.
Addressee of Rolling Forecasts and Firm Orders . All rolling
forecasts and purchase orders shall be sent by Distributor to the
person at the address identified on EXHIBIT B as such exhibit may
be amended from time to time by Manufacturer.
3.06.
Additional or Different Terms. Any rolling forecasts, purchase
orders, confirmations, acceptances, advices and similar documents
submitted by Distributor in conducting the activities contemplated
under this Agreement are for administrative purposes only and any
legal terms that may be included on such forms shall not add to or
modify the provisions of this Agreement. To the extent there are
any conflicts or inconsistencies between this Agreement and any
such document, the provisions of this Agreement shall control as to
a particular order unless otherwise agreed to in writing by the
Parties.
3.07.
Distributor License Responsibilities . Distributor shall be
responsible for obtaining all licenses, permits or authorizations
required for importing or exporting (returns) of
Products.
4. Prices,
Payment Terms and Security Interest.
4.01.
Prices. Attached hereto as Exhibit C is
Manufacturer’s anticipated price schedule for the Products. Manufacturer shall provide
Distributor with a final price schedule following the Approval
Date. All prices are exclusive of all **. Said prices shall be
subject to change by
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**
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REPRESENTS
MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES
ACT OF 1933, AS AMENDED.
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Manufacturer from time to time by ** days’ prior
written notice to Distributor, provided, however, that no such
price change shall affect purchase orders accepted by Manufacturer
prior to notifying Distributor of such price change or for Products
that are delivered prior to the effective date of the price change.
The prices at which the Products are resold in the Territory shall
be determined **.
4.02. Terms of
Payment. Unless otherwise agreed by the Parties in writing,
Manufacturer shall invoice Distributor upon shipping Products.
Payment shall be made by Distributor separately for each purchase
order accepted by Manufacturer, and Distributor shall remit payment
for Products in US Dollars within ** days of the invoice date. In
the event such remittance is not made in full within said period,
interest shall accrue on moneys outstanding from the due date to
the date of payment at the rate of ** (or the maximum legal rate
allowed, whichever is less).
4.03. Security
Interest. Manufacturer shall retain title to and a security
interest in the Products until all moneys payable hereunder are
paid in full. At Manufacturer’s request, Distributor will
execute such documents deemed necessary or desirable by
Manufacturer to perfect its security interest.
5. Marketing
and Advertising.
5.01.
Distributor’s Undertaking. Distributor shall exert its
best efforts to promote the sale of the Products in the Territory
and to develop a market demand for the same in the Territory.
Distributor will market the Products in a professional and ethical
manner. Distributor will not sell or market any Products in any
part of the Territory where proper regulatory approval has not been
obtained, unless approval is not required. Distributor shall
advertise the Products throughout the Territory in appropriate
advertising media and in a manner insuring proper and adequate
publicity for the Products. Distributor shall maintain a sales
organization which can be best utilized for the promotion of the
sales of the Products, which shall include at least 5 sales
representatives assigned to promote the Products.
5.02. Right to
Appoint Subdealers. Distributor shall have the right, at its
own discretion, to appoint a subdealer or subdealers to exploit the
Products in the Territory in accordance with the grant of the
distributorship pursuant to Section 2.01 above; provided that
(1) any subdealer shall only sell the Products to end-user
customers, and not to any third party for the purpose of resale by
such third party; (2) Distributor provides Manufacturer with
notice thereof prior to any such appointment that includes
(i) the identity of the subdealer; (ii) a description of
the products, and the rights being granted to the subdealer; and
(iii) the Territory in which the products will be sold by
subdealer and (iv) a copy of the subdealer agreement;
(3) the subdealer agreement shall be consistent with all the
terms and conditions of this Agreement, and shall include Field,
Territory and Sales Restrictions consistent with this Agreement;
and (4) Distributor shall remain responsible to Manufacturer
for the compliance of each such subdealer with the financial and
other obligations under this Agreement. Distributor shall not, nor
cause or permit any subdealer to, directly or indirectly, sell,
solicit orders for or otherwise deal in products which, in the
reasonable discretion of Manufacturer, are competitive with the
Products.
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**
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REPRESENTS
MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES
ACT OF 1933, AS AMENDED.
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5.03. Sales
Materials. Manufacturer agrees to provide Distributor, at no
cost to Distributor, such sales materials with respect to Products
as Manufacturer generally makes available to its distributors,
including technical specifications, drawings, advertisements and
samples, and Distributor may reproduce such materials as reasonably
required, provided that all copyright, trademark and other property
markings are reproduced. Such materials remain the property of
Manufacturer and, except insofar as they are distributed by
Distributor in the course of its performance of its duties under
this Agreement, must be promptly returned to Manufacturer upon the
expiration or termination of this Agreement.
5.04. Trade
Fairs and Exhibitions. Distributor agrees to participate in
trade fairs and exhibitions to market the Products in the
Territory, including, but not limited to, those designated by
Manufacturer in its sole discretion. The cost of the fairs or
exhibitions and displays, and the responsibility therefor, shall be
determined by the Parties in writing prior to each trade fair or
exhibition.
5.05. Sales
Force and Customer Service. Beginning upon the Approval Date,
Distributor will maintain a sales force of full-time sales
representatives in Canada, who are trained on the Product as well
as enough customer service representatives reasonably necessary to
support the Product sales in the Territory.
5.06 Product
Specialist. Manufacturer shall be permitted to provide Product
Specialists (at Manufacture’s expense) who are trained
specialist in the technical aspects of the Products, including the
Product design and methods of use. The Product Specialist shall be
permitted to work with the Distributor’s sales
representatives in promoting the Product, and shall be permitted to
attend and participate in sales calls, sales meetings, and sales
training sessions.
6.01. Training
for Distributor Personnel. At a mutually agreed upon time
following the Effective Date and in advance of an anticipated
Approval Date, Manufacturer shall provide Distributor, a technical
sales training session for qualified personnel designated by
Distributor, provided that Distributor shall be responsible for all
expenses for its personnel attending such training session. After
the completion of such training, Manufacturer shall provide, at a
time mutually convenient for the Parties, without charging any
consultation fees to Distributor, one (1) qualified employee of
Manufacturer to conduct annual technical sales training at
Distributor’s facility in Burlington, Ontario.
7. Product
Notifications and Recall.
7.01.
Notification by Distributor. Distributor will: (a) notify
Manufacturer in writing of any claim or proceeding involving the
Products within five (5) calendar days after Distributor
learns of such claim or proceeding; and (b) report promptly to
Manufacturer all claimed or suspected defects in the Products.
Distributor will notify Manufacturer of all potential adverse
experiences and/or injuries, serious and non-serious, no later than
five (5) calendar days from the date that Distributor learns
of the event. It will be Manufacturer’s sole responsibility
to report all
adverse
experience reports and other pharmacovigilance information to
regulatory bodies, worldwide.
7.02.
Recalls. If a product investigation by a party or government
office or agency results in a potential product recall or
correction of the Products, Manufacturer shall retain full
authority and responsibility for decisions on such recall or
correction. If Manufacturer decides to conduct a recall or
correction, Manufacturer will provide written notice to Distributor
that includes a summary of the reason for and implementation of
such action. Manufacturer shall provide such information as
Distributor may reasonably require to prepare any customer
notification of such recall or correction, which notification shall
be issued by Distributor.
7.03.
Procedure. Any recall, correction or notification shall be
handled in accordance with the recall, correction and customer
notification policy and procedures maintained by Manufacturer.
Manufacturer shall retain full authority and responsibility for
communication with regulatory bodies, worldwide, as it relates to
any recall or product notification.
7.04. Quality
Agreement. Prior to the Approval Date, the Parties shall enter
into a Quality Agreement which shall set forth each Party’s
responsibilities regarding quality matters relating to the
Products, and shall include the terms set forth in the attached
Exhibit E which describes Distributor’s responsibilities
relating to the Canadian Medical Device Regulations (CMDR) and
the Global Harmonization Task Force (GHTF) guidance document
on Device Adverse Reporting Systems for Canada. Manufacturer shall
have the right to perform a pre-qualification audit and subsequent
annual audits of Distributor’s facilities to ensure
compliance with the above regulations and Manufacturer’s SOPs
for storage and handling of the Products. Manufacturer shall
provide Distributor with at least two (2) weeks notice in
advance of such audit.
8.01.
Definition. As used in this Agreement, “Confidential
Information” means any proprietary or confidential
information, technical data, trade secrets or know-how of a Party
(the “Disclosing Party”), including, without
limitation, product formulations, research, product plans,
products, manufacturing techniques, service plans, services,
business plans, customer lists and customers, markets, software,
developments, inventions, processes, formulas, technology, designs,
drawings, engineering, marketing, distribution and sales methods
and systems and profit figures, finances and other business
information disclosed to the other Party hereto (the
“Receiving Party”) by or on behalf of the Disclosing
Party, either directly or indirectly, in writing, orally or by
drawings or inspection of documents or other tangible property;
provided that (a) any Confidential Information disclosed in
tangible form will be marked as confidential and/or proprietary
information by the Disclosing Party and (b) any Confidential
Information disclosed in intangible form will be identified as
confidential and/or proprietary information of the Disclosing Party
at the time of disclosure and summarized in writing to the
Receiving Party within thirty (30) days of its disclosure. The
Parties agree that the provisions of this Agreement shall be
considered the Confidential Information of both Parties and shall
not be disclosed by either Party except as set forth in this
Section 8.01.
8.02. Duties
of Confidentiality and Non-Use. During the Term, and for a
period of ten (10) years thereafter, the Receiving Party will
maintain in confidence all Confidential Information disclosed to it
by the Disclosing Party. The Receiving Party shall not use,
disclose or grant use of the Disclosing Party’s Confidential
Information except as required under this Agreement. To the extent
that disclosure is authorized by this Agreement, the Disclosing
Party shall obtain prior agreement from its employees, agents,
consultants, Affiliates, subcontractors and sublicensees
(collectively, the “Representatives”) to whom
disclosure is to be made to hold in confidence and not make use of
such information for any purpose other than those permitted by this
Agreement. Each Receiving Party shall use at least the same
standard of care as it uses to protect its own Confidential
Information to ensure that its Representatives do not disclose or
make any unauthorized use of such Confidential Information. Each
Receiving Party shall promptly notify the other upon discovery of
any unauthorized use or disclosure of Confidential
Information.
8.03.
Exceptions. The obligations regarding “Confidential
Information” set forth in this Section 8.03 shall not
apply to:
(a) information
that, at the time of disclosure, was published, known publicly, or
otherwise in the public domain;
(b) information
that after disclosure, is published, becomes known publicly, or
otherwise becomes part of the public domain through no fault of the
Receiving Party;
(c) information
that, prior to the time of disclosure, is known to the Receiving
Party, as evidenced by its written records, and is not then subject
to an obligation of confidentiality to any third party;
(d) information
that, after disclosure, is made available to the Receiving Party by
a third party under no obligation of confidentiality and without
restriction on its further disclosure by the Receiving Party;
and
(e) information
that is required to be disclosed pursuant to the order of any court
or governmental agency with competent jurisdiction or where
disclosure is otherwise required by law (provided, however, that
(i) any such disclosure shall not otherwise relieve the
Receiving Party of its continuing confidentiality and non-use
obligations hereunder with respect to all of the Confidential
Information, including the information disclosed by it to the court
or agency under this clause, and (ii) the Receiving Party
shall give the Disclosing Party reasonable advance notice of any
such disclosure and cooperate reasonably with the Disclosing Party
in the Disclosing Party’s efforts to object to such
disclosure and to obtain the recipient’s agreement to
maintain the confidentiality of the Confidential Information
disclosed under this clause).
8.04.
Permitted Disclosure. Each Party and its Representatives may
disclose Confidential Information to the extent such disclosure is
reasonably necessary for the purpose of the implementation of this
Agreement to individuals or entities bound by the same terms of
this Section 8.04. Each Party may also disclose Confidential
Information for purposes of complying with any applicable statute
or governmental regulation, and any required disclosure to Health
Canada or any other governmental regulatory authority, provided
however that such disclosing
Party gives
reasonable notice thereof to the nondisclosing Party so that the
nondisclosing Party may to appear, object and obtain a protective
order or other appropriate relief regarding such
disclosure.
9. Representations and Warranties,
Limitation of Liability .
9.01.
Authority. Each Party represents and warrants to the other that
(a) such Party is a corporation duly organized and validly
existing under the laws of the state or other jurisdiction of
incorporation or formation; (b) the execution and performance
of this Agreement by such Party has been duly authorized by all
requisite corporate action; and (c) the execution and
performance by such Party of this Agreement and its compliance with
the terms and provisions hereof does not and, to its knowledge,
will not violate any law, rule or regulation applicable to such
Party.
9.02. Limited
Warranty. Manufacturer grants to Distributor the warranty with
respect to the Products set forth in Article 6 of the
Statement of Terms and Conditions attached hereto as EXHIBIT
D.
9.03.
Exclusive Remedy. In the event of any failure by a shipment of
the Products to conform, in any material respect, to the warranty
set forth in Article 6 of EXHIBIT D, the only liability of
Manufacturer to Distributor, and Distributor’s sole and
exclusive remedy, shall be Manufacturer’s use of commercially
reasonable efforts to replace the shipment. Only in the event that
the Products received by Distributor do not conform to the Warranty
and after the use of commercially reasonable efforts to replace the
shipment is unsuccessful, Manufacturer shall refund payment to
Distributor.
9.04.
Disclaimer of Warranties. EXCEPT AS OTHERWISE SET FORTH HEREIN,
MANUFACTURER DISCLAIMS ANY WARRANTIES, EXPRESS OR IMPLIED, WITH
RESPECT TO THE PRODUCTS, INCLUDING, WITHOUT LIMITATION, ANY
WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT OR FITNESS FOR A
PARTICULAR PURPOSE.
10.01.
Indemnification by Manufacturer. Manufacturer shall defend
Distributor and its directors, officers and employees and any
Affiliate from and against any and all claims and suits
broug
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