Attached files
| file | filename |
|---|---|
| 8-K - OCCULOGIX 8-K 3-14-2010 - TearLab Corp | form8-k.htm |
| EX-5.1 - EXHIBIT 5.1 - TearLab Corp | ex5_1.htm |
| EX-99.3 - EXHIBIT 99.3 - TearLab Corp | ex99_3.htm |
| EX-99.1 - EXHIBIT 99.1 - TearLab Corp | ex99_1.htm |
| EX-99.4 - EXHIBIT 99.4 - TearLab Corp | ex99_4.htm |
DISTRIBUTION
AGREEMENT
THIS
DISTRIBUTION AGREEMENT (this “Agreement”) dated as of August
20, 2009 (the “Effective
Date”), is entered into between TearLab, Inc., a Delaware corporation
(“TearLab”), with a
place of business at 11025 Roselle Street, Suite 100, San Diego, California
92121, U.S.A., and Science with Vision, a Canadian corporation, with a place of
business at 5090 Explorer Drive, Mississauga, ON L4W4T9 (“Distributor”). The
parties hereby agree as follows:
1. APPOINTMENT AND
SCOPE
1.1 Appointment. Subject
to the terms and conditions of this Agreement, TearLab hereby appoints
Distributor, for the term of this Agreement, as the exclusive distributor of the
products described in Exhibit A (the “Products”) to customers
described in Exhibit A (the “Customers”) in the territory
described in Exhibit A (the “Territory”). Distributor
hereby accepts such appointment.
1.2 Distributorship
Restrictions.
(a) Distributor
shall resell the Products solely to Customers in the Territory.
(b) Distributor
shall not, directly or indirectly (i) make any sales of the Products
outside of the Territory, (ii) seek customers for, establish any branch
for, or maintain any distribution depot or network for the sale of the Products
outside of the Territory, or (iii) make any sales of the Products to any
third party other than to the customers in the Territory.
(c) Distributor
shall not have the right to, and shall not, appoint sub-distributors without the
prior express written consent of TearLab (which may be withheld in TearLab’s
sole discretion).
(d) Distributor
may commence distributing the Products in the Territory on ____________, 200__
(the “Launch Date”),
which is the later of receipt of medical device license from Health Canada and
(ii) the date Distributor receives the first shipment of Products from TearLab,
Inc, or as such date may be adjusted by mutual written agreement of the
parties.
1.3 Exclusivity. For
the purposes of Section 0 above, the term
“exclusive” means that, subject to the terms and conditions of this Agreement
(including, without limitation, Section 0) and
for as long as Distributor is in full compliance with its obligations hereunder,
TearLab shall not appoint any other agents, representatives or distributors in
the Territory to promote, market or sell the Products in the Territory. For
clarity, Distributor's exclusive distribution rights under this Agreement extend
solely to the Products listed in Exhibit A, and not to any other current or
future TearLab products, including without limitation any new TearLab products
having similar intended application.
1.4 Noncompetition. Unless
specifically authorized in writing by TearLab, Distributor shall not directly or
indirectly promote, market, sell, offer for sale, or act as sales agent for the
solicitation of orders in the Territory for any products used for the
measurement of osmolarity or osmolarity of the tear film.
1.5 Product Offerings by
TearLab. TearLab shall be under no obligation to Distributor
to continue its business or to continue, discontinue, change, retain,
manufacture, sell or supply any model or type of any of its
products. TearLab may, in its sole discretion, discontinue the supply
of any or all Products or make whatever changes to those Products it deems
necessary, desirable or appropriate. TearLab may, in its sole
discretion, add products to or delete products from the list of Products set
forth in Exhibit A upon thirty (30) days written notice to
Distributor.
1.6 Disposables. Distributor
acknowledges that the Products identified on Exhibit A as “disposable” (the
“Disposables”) are
perishable. Distributor shall manage its inventory such that the
Disposables are shipped throughout the Territory, to the extent reasonably
practicable, on a first-in-first-out basis. TearLab shall use
commercially reasonable efforts to provide Disposables with no more than
(a) four (4) months of the stated shelf life having elapsed on the date of
the shipment by TearLab to Distributor, for the Disposables having regulatory
allowed shelf life of less than eighteen (18) months, and (b) six (6)
months of the stated shelf life having elapsed on the date of the shipment by
TearLab to Distributor, for the Disposables having regulatory allowed shelf life
of at least eighteen (18) months. Distributor shall be responsible
for and shall bear the full risk with respect to any unsold quantities of the
Disposables remaining in Distributor’s inventory beyond the stated shelf-life
thereof. Without limiting the generality of the foregoing, and
notwithstanding anything to the contrary herein, the Disposables that remain
unsold in Distributor’s inventory beyond the stated shelf-life thereof shall not
be subject to any credits, refunds or exchanges.
1
1.7 Independent Purchaser
Status. Distributor is an independent purchaser and seller of
the Products. Distributor shall not act as an agent or legal
representative of TearLab. Distributor shall be responsible for all
of its own expenses and employees. Distributor shall incur no expense
chargeable to TearLab, except, as may be specifically authorized in advance in
writing in each case by TearLab, nor shall Distributor have any right or power
to act for or bind TearLab in any respect or to pledge its
credit. Distributor shall be free to resell the Products in the
Territory on such terms as it may, in its sole discretion, determine, including,
without limitation, price, returns, credits and discounts. The
detailed operations of Distributor under this Agreement are subject to the sole
control and management of Distributor.
|
2.
|
COVENANTS AND
WARRANTIES OF DISTRIBUTOR.
|
2.1 Minimum
Quantity. Distributor shall purchase from TearLab each
calendar year during the term of this Agreement commencing with the year of the
Launch Date (each such calendar year referred to herein as a “Contract Year”), and shall use
commercially reasonable efforts to resell, not less than the minimum purchase
quantity of the Products for such Contract Year as set forth in Exhibit A
(the “Minimum
Quantity”). If Distributor fails to purchase from TearLab and
to resell (a) the Minimum Quantity for any Contract Year, or (b) at
least twenty five percent (25%) of the Minimum Quantity for any Contract Year
during the first five (5) months of such Contract Year, TearLab shall have the
right, at TearLab’s sole option and discretion upon thirty (30) days written
notice to Distributor (i) to convert the distributorship grant under
Section 0 to non-exclusive, or (ii) to
terminate this Agreement. Notwithstanding the foregoing, if the
Launch Date occurs in the last calendar quarter of a year, then the first
Contract Year shall comprise the remainder of such year following the Launch
Date and the next calendar year.
2.2 Sales
Promotion. Distributor shall use commercially reasonable
efforts to promote, market and sell the Products in the Territory, to meet the
market demand for the Products for use in osmolarity testing in the
Territory. Distributor shall refrain from misrepresenting the origin
of the Products in such a way that would cause one to believe that the Products
are manufactured or developed by anyone other than
TearLab. Distributor shall distribute the Products in the Territory
so as to include all warnings and instructions necessary for the proper use of
the Products and shall not make any warranty, express or implied, relating to
the Products other than the warranty as described in Section 0.
2.3 Promotional
Materials. Distributor shall ensure that all advertising,
promotional literature and packaging for the Products comply with all applicable
laws and regulations. Distributor shall prepare necessary
translations of TearLab’s sales literature, package inserts and labeling for
TearLab’s review validation and editing as necessary before release to the
market. Distributor shall provide TearLab with all advertising,
promotional literature and materials in both the native language and with
English translations and shall not use any advertising or promotional materials
to promote the Products or any packaging that have not been approved by TearLab
in advance such consent not to be unreasonably withheld. Distributor
shall incorporate all reasonable comments by TearLab in the advertising or
promotional materials to promote the Products or any packaging or package
inserts therefor.
2.4 Registrations.
(a) Distributor
will notify TearLab promptly upon becoming aware of any governmental approval
requirements with respect to the Products in the Territory (other than the
requirement to obtain the European Union CE Mark approval for the
Products). If any such additional governmental registrations,
licenses, permits or approvals (collectively, “Registrations”) are required
in the Territory, then Distributor shall, at its own expense, obtain the
Registration that are necessary to permit the purchase, distribution and resale
by Distributor of the Products in each country in the
Territory. TearLab shall reasonably cooperate with the Distributor in
connection with obtaining the Registrations.
2
(b) All
Registrations shall be owned by and made in the name of
TearLab. Distributor shall provide TearLab with all tangible
documents, records, and other property relating to the
Registrations. Distributor shall have the right to maintain copies of
all Registrations, as necessary for Distributor’s activities authorized
hereunder. Distributor shall, at no cost to TearLab, execute such
documents and instruments and take such further actions as necessary or
appropriate to evidence TearLab’s ownership of the Registrations.
2.5 Conduct of
Business. Distributor shall conduct its business in a manner
that reflects favorably at all times on the Products and the good name, goodwill
and reputation of TearLab. Without limiting the generality of the
foregoing, Distributor shall (a) avoid deception, misleading or
unethical practices that are or might be detrimental to TearLab or the public,
including but not limited to disparagement of TearLab or the Products;
(b) not publish or employ, or cooperate in the publication or employment of
any misleading or deceptive advertising material; (c) make no
representations, warranties or guarantees to third parties with respect to the
specifications, features or capabilities of the Products that are inconsistent
with any representations, warranties or guaranties regarding the Products that
are expressly authorized by TearLab; (d) use marketing and advertising
efforts of high quality and good taste, and preserve the professional image and
reputation of TearLab and the Products; and (e) use professional and
properly trained sales force to promote, market and sell the
Products.
In
addition, and notwithstanding anything to the contrary herein or anything to the
contrary in any "Power of Attorney" document executed by TearLab to comply with
the regulations in the Territory, Distributor hereby agrees and acknowledges
that Distributor and its employees are not agents of TearLab, and except as
expressly authorized by TearLab under this Agreement they (i) shall have no
power or authority, whether apparent, actual, ostensible or otherwise, to bind
or commit TearLab in any way not expressly authorized in this Agreement, (ii)
shall not enter into any agreement, contract or arrangement with any government
or government representative or with any other person, firm, corporation, entity
or enterprise imposing any legal obligation or liability of any kind on TearLab,
and (iii) shall not sign TearLab's name to any commercial paper, contract or
other instrument and shall not contract any debt or enter into any agreement,
either express or implied, binding TearLab to the payment of money and/or in any
other regard. All agreements binding or committing TearLab in any manner
must be written agreements signed in advance by TearLab. Distributor and
its employees are not and shall not act as employees of TearLab for any purpose.
Distributor shall seek permission from TearLab prior to undertaking or
performing any material act on behalf of TearLab.
2.6 Compliance with
Laws. Distributor shall comply with all governmental laws,
regulations, and orders that may be applicable to Distributor by reason of its
execution of this Agreement, including, without limitation, any requirement to
be registered as TearLab’s independent distributor with any governmental
authority, and including any and all laws, regulations, or orders that govern or
affect the ordering, export, shipment, import, sale (including government
procurement), delivery, or redelivery of the Products in the
Territory.
2.7 Directive 2002/96/EC and
Directive 94/62/EC. If the Distributor’s Territory includes
any country in the European Union, then Distributor shall be responsible for
compliance with the Directive 2002/96/EC on waste electrical and electronic
equipment (WEEE) disposal, including Article 9 of the directive specifying
responsibility for the costs of collection, treatment, recovery and
environmentally sound disposal of WEEE from users other than private households
from products put on the market after 13 August 2005, and Distributor shall also
be responsible for compliance with Directive 94/62/EC on packaging and packaging
waste including the recovery and recycling of packaging waste.
2.8 U.S. Foreign Corrupt
Practices Act. Distributor warrants that in the performance of
its obligations under this Agreement, Distributor shall not act in any fashion
or take any action which will render TearLab liable for a violation of the U.S.
Foreign Corrupt Practices Act (“FCPA”), which prohibits the
offering, giving or promising to offer or give, directly or indirectly, money or
anything of value to any official of a government, political party or
instrumentality thereof in order to assist Distributor or TearLab in obtaining
or retaining business. TearLab shall have the right to terminate this Agreement
immediately if Distributor takes any action in violation of the U.S.
FCPA. Distributor shall indemnify and hold TearLab harmless from and
against all losses, liabilities, damages and expenses (including reasonable
attorneys’ fees and costs) relating to Distributor’s breach of this
Section 0.
3
2.9 Customer
Support. Distributor shall be solely responsible for
providing, and shall provide its customers and sub-distributors in the Territory
with all customer support, product training, new product in-service, repair and
servicing of out-of-warranty defective product, complaint handling and
post-market surveillance of adverse events with respect to the Products that is
necessary to support the normal use of the Products by customers. If
the Distributor’s Territory includes any country in the European Union,
Distributor shall ensure that the complaint handling procedures of Distributor
and any sub-distributors comply with vigilance and post-market surveillance
procedures of Directive 98/79/EC on in vitro diagnostic medical devices and that
these records are available to TearLab as per Section 2.14. With
respect to any country within the Territory that is not a part of the European
Union, Distributor shall comply with TearLab Quality System, ISO
13485.
2.10 Training. Distributor
shall cause all of its sales force personnel and sub-distributors to
become fully knowledgeable and achieve a high degree of competency with respect
to the Products, sufficient to meet Distributor’s customer support obligations
under Section 0 and to ensure compliance with
TearLab’s quality system including maintaining appropriate documentation of the
required training. Distributor shall be responsible for all costs and
expenses associated with training of its sales force, except that TearLab shall
provide a trainer at no cost to Distributor, and shall pay for the trainer’s
travel costs and expenses. Parties shall coordinate in good faith to
arrange for the training of Distributor’s sales force.
2.11
Inventory
Management. Distributor shall use commercially reasonable
efforts (a) to maintain its inventory of Products at a level sufficient to
meet the demand for Products in the Territory, and (b) to maintain an
inventory of replacement parts for the Products sufficient to meet its customer
support obligations for the Products under Section 0. Without limiting the generality of the
foregoing, at all times during the term of this Agreement, Distributor shall
maintain inventory levels of the Products and the replacement parts therefor to
ensure at least sixty (60) days of uninterrupted supply thereof in the
Territory. All terms and conditions set forth in Section 0 applicable to purchases of Products shall be
applicable to purchases of replacement parts therefor.
2.12 Records and
Reports. Distributor shall (a) maintain complete and
accurate books and records regarding this Agreement and the Products for a
period of time no less than seven (7) years from sale to the end user customer
and in the manner sufficient to ensure traceability of Products to the end user
customer to ensure compliance with vigilance and post-market surveillance
procedures of Directive 98/79/EC on in vitro diagnostic medical devices (for all
countries in the Territory within the European Union) or in compliance with
TearLab Quality System, ISO 13485 (for all countries in the Territory outside of
the European Union), including, but not limited to, records containing the
information supplied in the reports provided by Distributor to TearLab as
required below, (b) provide TearLab within thirty (30) days after the end
of each quarter with a report specifying in relation to such quarter the sales
results in the Territory, progress and development of the market for the
Products in the Territory and all regulations affecting their distribution, sale
and use, (c) provide TearLab within thirty (30) days after the end of each
quarter a written report detailing the number and nature of requests for support
received during the prior quarter, and such other information concerning
Distributor’s support obligations under Section 0 as TearLab may reasonably request, (d) provide
TearLab, at TearLab’s request, such other reports as are customarily provided by
Distributor to suppliers similarly situated with TearLab, and (e) permit
TearLab to have access to the accounts and records of the Distributor so far as
may be necessary to confirm Distributor’s compliance with vigilance and
post-market surveillance procedures of Directive 98/79/EC on in vitro diagnostic
medical devices.
4
2.13 Product
Recalls. Distributor shall promptly implement any Product
recall issued by TearLab, at TearLab’s expense. Distributor shall
maintain an accurate and up-to date Product and customer database which shall be
sufficient to enable Distributor, if TearLab so instructs, promptly to recall
all units of any specific lot number of any Product. If the
Distributor implements a voluntary recall, all costs and expenses associated
with any such recall shall be borne by the Distributor, provided that TearLab
shall reimburse Distributor for any reasonable out-of-pocket costs of
Distributor pertaining to such recall if the Distributor demonstrates by
reasonable evidence that the Distributor’s voluntary recall was reasonable and
justifiable.
|
3.
|
TERMS AND CONDITIONS
OF SALE.
|
3.1 Terms. During
the term of this agreement, commencing with the Launch date, DISTRIBUTOR shall
submit to TearLab, in writing, before the sixtieth (60th) day of each calendar
quarter a report of DISTRIBUTOR’s sales and inventory of the Product, including
the level of inventory of the Product by article. DISTRIBUTOR also shall
submit to TearLab, upon request from time to time, information in its possession
with respect to general market information, relevant economic, political and
business conditions in the Territory, and texts and summaries of governmental
statutes, rules and regulations established or revised from time to time,
affecting the marketing or sale of the Product in the Territory.
3.2 Marketing
Plan. As a part of this agreement, DISTRIBUTOR shall submit to
TearLab, in writing, prior to the completion of this agreement, a marketing plan
utilizing the TearLab Marketing Plan template. At a minimum, the
marketing plan shall include customer forecasts, reimbursement plans, education
summaries, sales cycle forecasts and reader and test card sales
forecasts.
3.3 Rolling
Forecasts. DISTRIBUTOR shall submit to TearLab a calendar
twelve (12) month rolling order forecast. Not less than ten (10) days prior
to each quarter during the term of this Agreement commencing with the Launch
Date, Distributor shall prepare and provide OcuSense with a twelve (12) month
rolling forecast of its estimated purchase requirements for each of the Products
(the “Rolling
Forecast”). The Rolling Forecast shall be non-binding and for
planning purposes only. The initial Rolling Forecast is attached
hereto as Exhibit C.
3.4 Purchase
Orders.
(a) Distributor
shall make all purchases of Products hereunder by submitting firm written
purchase orders to TearLab. No purchase order shall be binding upon
TearLab unless and until a written acknowledgement thereof is dispatched by
TearLab to Distributor. TearLab reserves the right to specify a
reasonable minimum Product quantity per purchase order. All purchase
orders must clearly indicate the bill to address, ship to address, shipping
method, Products ordered and quantity. Distributor may use its
standard purchase order form; provided, however, that the terms and conditions
of this Agreement shall supersede any different, conflicting, or additional
terms on Distributor’s purchase orders, and TearLab hereby expressly rejects any
terms in any purchase order that are different from, in conflict with or in
addition to the terms and conditions hereof. TearLab will notify
Distributor if TearLab does not accept any purchase order.
(b) The
first purchase order for the Products is attached hereto as
Exhibit D. Within thirty (30) days after the Effective Date,
Distributor shall deliver to TearLab a payment in full for the Products ordered
by Distributor in such first purchase order. If Distributor does not
specify the requested delivery dates for all Products ordered via such first
purchase order, Distributor may do so in writing after the Launch
Date.
3.5 Shipping. Unless
TearLab otherwise expressly agrees in writing, the lead time for shipping shall
be not more than 45 working days after acknowledgement of Distributor’s purchase
order by TearLab. TearLab may defer shipment of the Products if and
while Distributor is in default of any of its obligations owing to TearLab under
this Agreement, including Distributor’s obligations to pay any amounts when
due. The Products shall be delivered FCA TearLab facility at an
TearLab Distribution facility in the United States (Incoterms 2000). Risk
of loss shall pass to Distributor upon delivery by TearLab to Distributor’s
designated carrier. Distributor shall be responsible to pay all
carrier costs, shipping and handling charges, insurance charges, and all customs
duties, taxes and any other charges levied by any governmental body in
connection with shipping of the Products to Distributor.
5
|
4.
|
PRICE AND
PAYMENT.
|
4.1 Price. Prices
payable by Distributor for the Products shall be the transfer prices set forth
in Exhibit A. All prices and payments under this Agreement shall
be in U.S. Dollars.
4.2 Payment
Terms. Distributor shall make all payments in United States
dollars, in immediately available funds, by wire transfer to such account as
TearLab designates for such purpose. Distributor shall pay for each shipment of
the Products within thirty (30) days of receipt.
4.3 Taxes. Distributor
shall pay all sales, use and transfer taxes and other charges arising out of the
purchase and sale of the Products, including any state and local personal
property taxes and all inspection fees and duties, applicable to the sale and
transport of the Products by Distributor in the Territory which are applicable
thereto. TearLab shall not be responsible for any business,
occupation, withholding or similar tax, or any taxes of any kind, relating to
the purchase and sale of the Products.
|
5.
|
WARRANTIES AND
DISCLAIMERS.
|
5.1 Warranty. TearLab
warrants and represents solely to the customers purchasing the Products from
Distributor, that the Products shall be of good quality and free from defects,
whether patent or latent, in design, materials or workmanship, as further
described in the manual or insert accompanying the Products. The
warranty term for each Disposable expires upon the expiration date for such
Disposable. The warranty term for all other Products is as stated in
the manual or insert accompanying the Products.
5.2 Products
Returns.
(a) If
a Product fails to conform to the warranty as described in Section 0, Distributor may authorize the return of such
nonconforming Product by customer and may return such Product to TearLab during
the one (1) year warranty period, at TearLab’s expense; accompanied by
(a) a copy of a sales receipt of such Product to customer (for the purposes
of evidencing the applicable warranty period), and (b) a Return Material
Authorization (“RMA”)
number for the defective Product obtained from TearLab prior to initiating the
shipment of the defective Product to TearLab. Products returned
without such sales receipt and a valid RMA number shall be returned to
Distributor at Distributor’s expense, with no further obligation by TearLab to
Distributor regarding such Product. If Distributor returns a Product
in compliance with the foregoing requirements, TearLab shall replace or repair
the returned Product as soon as reasonably practicable. The
replacement Product may be new or refurbished, at TearLab’s discretion, provided
that any such replacement or repaired Product shall fully comply with the
warranty terms, as described in Section 0. Such replacement or repaired Product
shall be at no additional cost to Distributor if Distributor had previously paid
TearLab for the returned Product.
(b) If
Distributor discovers that Products contained in a shipment by TearLab fail to
conform to the applicable acceptance criteria therefore as set forth on
Exhibit E, Distributor may return such nonconforming Products to TearLab
within fifteen (15) business days after delivery to Distributor, at TearLab’
expense; provided, however that Distributor shall first give prompt written
notice to TearLab of any Products defects (no later than within ten (10)
business days after delivery of the Product to Distributor), at which time
TearLab shall issue an RMA number for the defective Products. If
Distributor fails timely to give such notice and to receive the RMA number,
Distributor shall be deemed to have accepted the Products. Products
returned without a valid RMA number shall be returned to Distributor at
Distributor’s expense. If Distributor returns a Product in compliance
with the foregoing requirements, TearLab shall replace the returned Product as
soon as reasonably practicable. Such replacement Product shall be at
no additional cost to Distributor if Distributor had previously paid TearLab for
the returned Product. Notwithstanding the foregoing, TearLab shall
not be responsible for any Products that fails to pass Distributor’s quality
control as a result of improper storage and handling during or after shipment to
Distributor. Distributor may not reject a Product unless the Product was damaged
at the time of shipment.
(c) NOTWITHSTANDING
ANYTHING TO THE CONTRARY IN THIS AGREEMENT, THE REPLACEMENT OF THE NONCONFORMING
PRODUCTS BY TEARLAB AS PROVIDED UNDER THIS SECTION 0 SHALL BE DISTRIBUTOR’S SOLE AND EXCLUSIVE REMEDY FOR
TEARLAB’S DELIVERY OF NONCONFORMING PRODUCTS.
6
5.3 WARRANTY
DISCLAIMERS. OTHER THAN AS WARRANTED UNDER SECTION 0, THE PRODUCTS ARE PROVIDED “AS
IS.” TEARLAB PROVIDES NO WARRANTY OF ANY KIND TO
DISTRIBUTOR. WITH THE EXCEPTION OF THE LIMITED WARRANTY THAT TEARLAB
PROVIDES SOLELY TO THE CUSTOMERS, AS SET FORTH IN SECTION 0, TEARLAB MAKES NO OTHER WARRANTIES RELATING TO THE
PRODUCTS, EXPRESS OR IMPLIED, AND EXPRESSLY DISCLAIMS ANY AND IMPLIED
WARRANTIES, INCLUDING WITHOUT LIMITATION WARRANTIES OF NON-INFRINGEMENT, FITNESS
FOR A PARTICULAR PURPOSE OR MERCHANTABILITY. DISTRIBUTOR SHALL
DISTRIBUTE THE PRODUCTS IN THE TERRITORY SO AS TO INCLUDE ALL WARNINGS AND
INSTRUCTIONS NECESSARY FOR THE PROPER USE OF THE
PRODUCTS. DISTRIBUTOR SHALL NOT MAKE ANY WARRANTY, EXPRESS OR
IMPLIED, RELATING TO THE PRODUCTS OTHER THAN THE WARRANTY SET FORTH IN
SECTION 0.
5.4 LIMITATION OF
LIABILITY. IN NO EVENT SHALL TEARLAB OR THE DISTRIBUTOR BE
LIABLE TO EACH OTHER, ANY CUSTOMER OR ANY OTHER THIRD PARTY IN ANY MANNER FOR
ANY SPECIAL, NON-COMPENSATORY, CONSEQUENTIAL, INDIRECT, INCIDENTAL, STATUTORY OR
PUNITIVE DAMAGES OF ANY KIND, INCLUDING, WITHOUT LIMITATION, FOR LOST PROFITS,
LOST SALES, LOST REVENUE OR LOSS OF USE, REGARDLESS OF THE FORM OF ACTION,
WHETHER IN CONTRACT, TORT, NEGLIGENCE, STRICT PRODUCTS LIABILITY, OR OTHERWISE,
EVEN IF THE DISTRIBUTOR OR TEARLAB HAS BEEN INFORMED OF OR IS AWARE OF THE
POSSIBILITY OF ANY SUCH DAMAGES IN ADVANCE. THE DISTRIBUTOR OR
TEARLAB’S TOTAL AGGREGATE LIABILITY IN CONNECTION WITH THIS AGREEMENT OR THE
PRODUCTS SHALL BE LIMITED TO THE SUM OF THE AMOUNTS PAID BY DISTRIBUTOR TO
TEARLAB DURING THE SIX (6) MONTHS IMMEDIATELY PRECEDING THE DATE OF THE EVENT
GIVING RISE TO A CLAIM . DISTRIBUTOR AND TEARLAB HAVE ACCEPTED THIS
LIMITATION OF LIABILITY. NOTWITHSTANDING THE FOREGOING, TEARLAB’S OR
THE DISTRIBUTOR’S LIABILITY (A) FOR DEATH OR PERSONAL INJURY CAUSED BY
TEARLAB’S OR THE DISTRIBUTOR’S NEGLIGENCE OR CAUSED BY THE NEGLIGENCE OF
TEARLAB’S OR THE DISTRIBUTOR’S EMPLOYEES OR AGENTS; AND (B) FOR ANY
FRAUDULENT MISREPRESENTATION BY TEARLAB OR THE DISTRIBUTOR IS NOT EXCLUDED OR
LIMITED BY THIS AGREEMENT, EVEN IF ANY OTHER TERM OF THIS AGREEMENT WOULD
PROVIDE OR SUGGEST OTHERWISE.
|
6.
|
CONFIDENTIALITY. [UNDER
CONSIDERATION]
|
6.1 Confidentiality
Obligations. During the term of this Agreement, and for a
period of five (5) years following the expiration or earlier termination hereof,
Distributor and TearLab shall maintain in confidence all information relating to
the Products or otherwise relating to TearLab’s or the Distributor’s business,
and received directly or indirectly from TearLab or the Distributor
(collectively, the “Confidential Information”),
and shall not use, disclose or grant the use of the Confidential Information
except on a need-to-know basis to those of its directors, officers and employees
to the extent such disclosure is reasonably necessary in connection with
Distributor’s or TearLab’s activities as expressly authorized by this
Agreement. To the extent that disclosure is authorized by this
Agreement, prior to disclosure, Distributor and TearLab shall obtain agreement
of any such person or entity to hold in confidence and not make use of the
Confidential Information for any purpose other than those permitted by this
Agreement. Distributor and TearLab shall notify each other promptly
upon discovery of any unauthorized use or disclosure of the Confidential
Information.
6.2 Confidentiality
Exceptions. The obligations of Distributor and TearLab under
Section 0 shall not apply to any information
with respect to which Distributor or TearLab is able demonstrate by written
evidence that such information (a) was publicly known prior to the
disclosure of such information to Distributor or TearLab; (b) became
publicly known, without fault on the part of Distributor or TearLab, subsequent
to disclosure by TearLab or Distributor of such information to the other party;
(c) was otherwise known by Distributor or TearLab prior to
communication by TearLab or Distributor to the other party of such information;
or (d) was received by Distributor or TearLab at any time from a source
other than TearLab or Distributor lawfully having the right to disclose such
information.
7
6.3 Permitted
Disclosures. The confidentiality obligations contained in
Section 0 above shall not apply to the extent
that Distributor or TearLab is required to disclose information by law,
regulation or order of a governmental agency or a court of competent
jurisdiction, provided that Distributor or TearLab shall provide written notice
thereof to each other and sufficient opportunity to object to any such
disclosure or to request confidential treatment thereof.
|
7.
|
INDEMNIFICATION AND
INSURANCE.
|
7.1 Indemnity. Each
party (the “Indemnitor”)
shall defend, indemnify and hold the other party (the “Indemnitee”) harmless from all
losses, liabilities, damages and expenses (including reasonable attorneys’ fees
and costs) resulting from any claims, demands, actions and other proceedings by
any third party to the extent resulting from (a) any breach of this
Agreement by the Indemnitor, (b) any recklessness or intentional act or
omission by or on behalf of the Indemnitor in the performance of its activities
contemplate by this Agreement, (c) any misrepresentations by the
Indemnitor, or (d) any violation by the Indemnitor (or any of its employees
or agents) of, or failure to adhere to, any applicable law, regulation or order
in any country, in each case other than those certain losses, liabilities,
damages and expenses arising out of the gross negligence or willful misconduct
of the Indemnitee. The obligations of the parties under this
Section 0 shall survive expiration or
termination of this Agreement.
7.2 Indemnity
Procedure. The Indemnitee shall promptly notify the Indemnitor
of any event in respect of which the Indemnitee intends to claim
indemnification, and the Indemnitor shall have the right to participate in, and,
to the extent the Indemnitor so desires, to assume the defense thereof with
counsel selected by the Indemnitor; provided, however, that the Indemnitee shall
have the right to retain its own counsel, with the fees and expenses to be paid
by the Indemnitor, if representation of the Indemnitee by the counsel retained
by the Indemnitor would be inappropriate due to actual or potential differing
interests between the Indemnitee and any other party represented by such counsel
in such proceedings. The indemnity obligations under Section 0 shall not apply to amounts paid in settlement of any
loss, claim, damage, liability or action if such settlement is effected without
the consent of the Indemnitor, which consent shall not be withheld
unreasonably. The failure to deliver notice to the Indemnitor within
a reasonable time after the commencement of any such action, if prejudicial to
its ability to defend such action, shall relieve such Indemnitor of any
liability to the Indemnitee under Section 0,
but the omission so to deliver notice to the Indemnitor will not relieve it of
any liability that it may have to any Indemnitee otherwise than under
Section 0. The Indemnitor may not
settle the action or otherwise consent to an adverse judgment in such action
that diminishes the rights or interests of the Indemnitee without the express
written consent of the Indemnitee. The Indemnitee, its employees and
agents, shall cooperate fully with the Indemnitor and its legal representatives
in the investigation of any action, claim or liability covered by this
indemnification.
7.3 Insurance. Each
party shall maintain commercial general liability insurance, including
contractual liability insurance and products liability insurance against claims
regarding its activities contemplated by this Agreement, in such amounts as it
customarily maintains for similar products and activities. Each party
shall maintain such insurance during the term of this Agreement and thereafter
for so long as it maintains insurance for itself covering such
activities.
|
8.
|
TRADEMARK
MATTERS.
|
8.1 Trademarks and Trade
Names. Distributor shall not use any of TearLab’s trademarks,
or any mark or name confusingly similar thereto, as part of its corporate or
business name or in any other manner, except that:
(a) Distributor
may identify itself as an authorized Distributor of TearLab; and
(b) Distributor
may use any of TearLab’s trademarks set out in Exhibit F (the “Trademarks”) for display
purpose in connection with the solicitation of orders for the
Products. Use of the Trademarks shall be subject to written prior
approval from TearLab, such approval not to be unreasonably
withheld. Distributor agrees that TearLab’s approval shall not be
considered to be unreasonably withheld if Distributor’s use (or intended use) of
such Trademarks in TearLab’s opinion misrepresents (or would misrepresent) the
Products or could confuse as to the ownership of trademarks or of origin or
quality of the Products.
8
(c) Distributor
shall not register any trade mark or trade name (including any company name)
which is identical to or confusingly similar to or incorporates any trade mark
or trade name which TearLab or any associated company owns or claims rights in,
including but not limited to the Trademarks.
8.2 Goodwill. Any
goodwill associated with any trade marks affixed or applied or used in relation
to the Products shall accrue to the sole benefit of TearLab or such associated
company of TearLab as owns such trade marks.
8.3 Products
Markings. Distributor shall not alter, remove or modify any
TearLab trademarks, labels or markings, nor affix any other trademarks, labels,
instructions, warnings or markings to or on the Products or the packages or
boxes used for the Products without TearLab’s written consent not to be
unreasonably withheld; provided that Distributor may affix labels or other
indices on the Products it distributes to identify Distributor as the
distributor of the Products so long as such labels do not cover and are not
inconsistent with TearLab’s trademarks, labels or markings. No other
Distributor labels, package inserts or other material shall accompany the
Products without the approval of TearLab not to be unreasonably
withheld. Nothing in this Agreement shall create an obligation on
TearLab to register or otherwise maintain in force any
trademarks. This clause 8.3 will not apply to markings or documents
the Distributor is required by law to attach to or insert in the packaging of
the Products, provided that Distributor shall notify TearLab of any such
requirement in advance.
8.4 Intellectual Property
Infringement. Distributor shall inform TearLab immediately
upon becoming aware of: (a) any infringements or risk of infringements by a
third party of TearLab’s intellectual property (including but not limited to
brands, trademarks, copyrights, and patents), (b) any infringements or risk of
infringements by TearLab’s products of a third party’s intellectual property or
claims of such by a third party. In the event of any such
infringement, TearLab shall have the sole right to conduct (at TearLab’s sole
expense) the defense or settlement of any claim of intellectual property right
infringement by or against a third party in relation to any of TearLab’s
intellectual property. At TearLab’s expense (as to reasonable
out-of-pocket expenses only), Distributor cooperate with TearLab in connection
with any such infringement defense or prosecution.
|
9.
|
TERM AND
TERMINATION.
|
9.1 Term. Unless
terminated as provided in Section 0 below or by
mutual written consent, this Agreement shall continue in full force and effect
for an initial term expiring at the conclusion of the third Contract Year (the
“Initial
Term”). Thereafter, solely if Distributor has maintained
compliance with this Agreement, including without limitation meeting its Minimum
Quantity obligations, during each preceding Contract Year during the term of
this Agreement, this Agreement shall automatically renew for an additional
renewal terms comprising one Contract Year each (each, a “Renewal Term”). The
parties shall agree in writing on a Minimum Quantity for each Renewal Tem at
least ninety (90) days prior to the commencement thereof.
9.2 Termination. This
Agreement may be terminated as follows:
(a) By
either party, if the other party commits a material breach of this Agreement and
fails to cure such material breach within thirty (30) calendar days after
receiving written notice thereof;
(b) By
TearLab, immediately upon written notice to Distributor if Distributor breaches
any provision of Sections 0, 0, 0, 0 or 0.
9.3 Rights of Parties on
Expiration or Termination. The following provisions shall
apply on the expiration or termination of this Agreement.
(a) Distributor
shall deliver to TearLab a list of Products in Distributor’s inventory, and
TearLab shall have the right (but not the obligation) to buy any or all of the
Products in Distributor’s inventory at the then-current transfer price, as
determined in accordance with Section 0, or,
in TearLab’s sole discretion, TearLab may authorize Distributor to have a
non-exclusive right, for a period of such length as shall be determined by
TearLab, based upon inventory numbers, in its sole discretion (the
“Sell-Off Period”), to
sell the Products in Distributor’s inventory in accordance with the terms and
conditions set forth in this Agreement. At no time shall the Sell-Off Period
exceed six (6) months.
9
(b) At
the time Distributor may no longer distribute or sell the Products in accordance
with Section 0, Distributor promptly
shall:
(i) remove
from its property and immediately discontinue all use, directly or indirectly,
of trademarks, designs, and markings owned or licensed exclusively by TearLab,
or any word, title, expression, trademark, design, or marking that is
confusingly similar thereto;
(ii) if
TearLab is repurchasing any Products in accordance with Section 0, deliver such Products to TearLab, following
TearLab’s reasonable instructions;
(iii) promptly
deliver to TearLab all records, files, data and information whatsoever relating
in any way to the sale, distribution, marketing or promotion of the Products in
the Territory, including, without limitation, all Product and customer
information maintained by Distributor under Section 0 and Section 0 to
enable TearLab to implement Product recalls; and
(iv) provide
to TearLab a final report containing all information required under
Section 0 and which has not been previously
provided to TearLab.
(c) The
following Sections shall survive any termination or expiration of this
Agreement: 0, 0, 0, 0, 0, 0, 7.3, 0, 9.3 and 0.
|
10.
|
GENERAL
PROVISIONS.
|
10.1 Governing Law; This
Agreement and all disputes and claims arising out of or in connection with its
subject matter are governed by and construed in accordance with the law of
U.S.A. and the State of California, without reference to the conflict of laws
rules thereof. In the event of any controversy or claim arising out
of or relating to any provision of this Agreement or the breach thereof, the
parties will try to settle their differences amicably by
themselves. Any such controversy or claim, which the parties are
unable to resolve, shall initially be submitted for review and resolution by the
senior management of the parties. Thereafter, any disagreements that prevail for
more than sixty (60) days shall be settled by
arbitration. Arbitration shall be held in San Diego, California,
U.S.A, in accordance with the Rules of Conciliation and Arbitration of the
International Chamber of Commerce, by three (3) arbitrators appointed in
accordance with the said Rules, and the award there under shall be final and
binding upon both parties. Language of arbitration shall be
English.
10.2 Language. The
English language version of this Agreement shall govern and control any
translations of this Agreement into any other language.
10.3 Notices. All
consents, notices or reports required or permitted to be given or made by one
party to the other under this Agreement shall be in writing and addressed to the
other party at its address indicated above, or to such other address as the
addressee shall have last furnished in writing to the addressor, and shall be
effective upon receipt by the addressee.
10.4 Assignment. Distributor
may not assign this Agreement or any of its rights, duties and obligations
hereunder without the prior written consent of TearLab. Any purported
assignment in violation of the foregoing shall be void. Any permitted
assignee shall assume all obligations of Distributor under this
Agreement. TearLab may assign this Agreement, in full or in part,
without Distributor’s consent. Should TearLab assign this agreement,
said assignee shall assume TearLab’s full obligations under this
Agreement.
10.5 Entire
Agreement. This Agreement contains the entire understanding of
the parties with respect to the subject matter hereof. All express or
implied representations, agreements and understandings with respect to the
subject matter hereof, either oral or written, heretofore made are expressly
superseded by this Agreement. This Agreement may be amended, or any
term hereof modified, only by a written instrument duly executed by both
parties.
10.6
Headings. The
captions to the several Sections hereof are not a part of this Agreement, but
are merely guides or labels to assist in locating and reading the several
Sections hereof.
10
10.7 Independent
Contractors. Each party hereby acknowledges that the parties
shall be independent contractors and that the relationship between the parties
shall not constitute a partnership, joint venture or agency. Neither
party shall have the authority to make any statements, representations or
commitments of any kind, or to take any action, that shall be binding on the
other party, without the prior consent of the other party to do so.
10.8 Waiver. Тhe failure of a
party at any time to require performance by the other party of any of the
provisions herein shall not operate as a waiver of the right of such party to
request strict performance of the same or like provisions or any other
provisions hereof, at a later time.
10.9 Force
Majeure. TearLab shall use its reasonable efforts to fill
orders, but TearLab shall not be liable for nonperformance or delays caused by a
shortage of raw materials, labor problems, acts of regulatory agencies, acts of
God or other causes beyond its reasonable control.
10.10 Counterparts. This
Agreement may be executed in two or more counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same
instrument.
10.11 Severability. In
the event that any one or more provisions contained herein shall be held by a
court of competent jurisdiction to be invalid, illegal or unenforceable in any
respect, the validity, legality and enforceability of the remaining provisions
contained herein shall not in any way be affected or impaired thereby and the
parties agree to replace such invalid, illegal or unenforceable term or
provision with an enforceable and valid arrangement that, in its economic
effect, shall be as close as possible to the invalid, illegal or unenforceable
term or provision.
IN
WITNESS WHEREOF, TearLab and Distributor have caused this Agreement to be
executed by their duly authorized representatives, as of the Effective
Date.
|
TearLab,
Inc.
|
[DISTRIBUTOR]
|
||||
|
By:
|
/s/ Robert Walder
|
By:
|
/s/ Jerry Nolfi
|
||
|
Name:
|
Robert Walder
|
Name:
|
|||
|
Title:
|
Vice President - Operations
|
Title:
|
|||
11