Exhibit 10.1

 

 

 

 

     [****]SUPPLY AGREEMENT [****]

(GE Healthcare [****] Products – [****])

 

1. GEHC

 

GE HEALTHCARE BIO-SCIENCES CORP.

100 Results Way

Marlborough, MA  01752

 

(“GEHC”)

 

2. PURCHASER

 

T2 BIOSYSTEMS, INC.

101 Hartwell Ave.

Lexington, MA 02421

 

(“Purchaser”)

3.   PRODUCTS

 

PRODUCTCODEPACK SIZE[****][****][****]

 

4. COMBINATION PRODUCTS

 

Combination Products shall mean:  

Kits sold under the Purchaser’s own label that incorporates the Product that is
described in Box 3.  

 

Combination Products specifically exclude the Products sold on a stand-alone
basis whether under the Purchaser’s own label or not and whether or not the pack
size has been modified by the Purchaser.

 

 

 

5. MINIMUM PURCHASE REQUIREMENT

 

Annual Minimum Purchase Requirement the greater of [****] packs or [****]% of
previous calendar year and renewing at the start of each calendar year
throughout the Term.

 

6. FIELD

 

Clinical diagnostics and life sciences research market

 

7. LICENSED TRADEMARKS

 

None

 

8. TERRITORY

 

Worldwide

9.  EFFECTIVE DATE AND TERM

 

Effective Date: ____March 1, 2019________

 

Term: 3 years, with successive two year auto-renewal periods thereafter up to 8
years.

 

 

 

In witness whereof, the parties hereto have caused their respective duly
authorized representatives to execute this Agreement the day and year first
above written.

 

 

For and on behalf ofFor and on behalf of

 

GE HEALTHCARE [****].T2 BIOSYSTEMS, INC.

 

 

Signature________________________Signature__________________________

 

Name (capitals) ___________________Name (capitals) ___________________________

 

Title ____________________________ Title________________________________

 

[****] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

 

--------------------------------------------------------------------------------

 

 

Date ____________________________ Date________________________________

 

 

 

[****] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

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[****] SUPPLY AGREEMENT [****]

(GE Healthcare [****])

 

1.

Definitions

 

"Affiliate" means any entity that directly or indirectly controls, is controlled
by or is under common control with a party, for so long as such control
continues. For the purposes of this definition, "control" means the possession,
directly or indirectly, of the power to direct or cause the direction of the
management and policies of the controlled entity, whether through the ownership
of voting securities, partnership, other ownership interests, by contract or
otherwise.

 

“Combination Products” means the apparatus, instrument, device or product listed
on Box 4, Page 1 that conforms to quality and workmanship standards and
incorporates one or more Products.

 

"Confidential Information" means, with respect to a party, subject to the
exceptions set forth herein, any information of a confidential, proprietary or
secret nature, in whatever form or media, relating to such party or any of its
Affiliates or their respective businesses or operations, whether or not
technical in nature and whether or not the information has been provided or
disclosed prior to or after the date of this Agreement (together with any notes,
summaries, reports, analyses or other material derived by Recipient of such
information or its Representatives that contain or otherwise reflect such
information). Such information shall include, without limitation: (i) the
existence and terms of this Agreement; (ii) information of technical or
scientific nature relating to or concerning know-how, technical data, computer
programs and systems, designs, data bases, inventions, manufacturing or
engineering techniques and procedures, equipment, materials, product designs and
specifications, test and quality assurance procedures, research and research
projects, and plans for future development; (iii) information of business
nature, including trade secrets, prices of the Products and any other pricing
information, sales data, customer lists and other information related to
customers, customer purchase history, marketing or sales plans, distribution
details, product plans, business strategies, costs, profits, formulae, markets,
information related to suppliers, customers, agents and/or consultants and
information relating to employees, training methods; (iv) all information that
is designated as "confidential" or "proprietary" by the Disclosing Party at the
time of disclosure; and (v) information entrusted to a party or any of its
Affiliates by any other person on a confidential basis.

 

“End User” means an individual or entity that purchases a Combination Product
solely for its internal use and not for resale.

 

"Field" means the field of use set for th Box 6, Page 1.

 

“Intellectual Property Rights” means all worldwide (i) inventions, whether or
not patentable; (ii) patents and patent applications; (iii) trademarks, service
marks, trade dress, logos, internet domain names and trade names, whether or not
registered, and all goodwill associated therewith, (including the Trademarks);
(iv) copyrights and related rights, whether or not registered; (v) computer
software, data, databases, files and documentation and other materials related
thereto; (vi) trade secrets and confidential, technical and business
information; (vii) all rights therein provided by bilateral or international
treaties or conventions; and (viii) all rights to sue or recover and retain
damages and costs and attorney’s fees for past, present and future infringement
or misappropriation of any of the foregoing.

 

”Licensed Trademarks” means those Trademarks listed in Schedule 3 that GEHC has
granted Purchaser the right to use.

 

“Minimum Purchase Requirement” means Purchaser’s minimum purchase obligation in
each calendar year as set forth in Box 5, Page 1

.

“Permitted Affiliate” means an Affiliate of Purchaser that is permitted to sell
Products solely in connection with Combination Products under the terms and
conditions of this Agreement; provided that Purchaser shall ensure that, (i)
each such Affiliate complies with the terms of this Agreement and all applicable
law, including all export, anti-money laundering and restricted country
treaties, statutes, or other relevant laws or regulations and (ii) subject to
GEHC’s right to stop Purchaser from selling Products under this Agreement, upon
notice thereof, Purchaser shall also cause such Affiliate to immediately stop
selling Products upon written notice from GEHC.  

 

“Permitted Distributor” means the third parties that have a valid and existing
agreement with Purchaser permitted such parties to sell Combination Products;
provided that Purchaser shall ensure that , (i) each such third party complies
with

the terms of this Agreement and all applicable law, including all export,
anti-money laundering and restricted country treaties, statutes, or other
relevant laws or regulations and (ii)subject to GEHC’s right to stop Purchaser
from selling Products under this Agreement, upon notice thereof, Purchaser shall
also cause such third parties to immediately stop selling Products upon written
notice from GEHC.

 

”Permitted Manufacturer” means a third party manufacturer that Purchaser engages
to manufacture Combination Products and incorporate the Products into
Combination Products under the terms and conditions of this Agreement; provided
that Purchaser shall ensure that (i) each such third party manufacturer complies
with the terms of this Agreement and all applicable law, including all export,
anti-money laundering and restricted country treaties, statutes, or other
relevant laws or regulations and (ii) subject to GEHC’s right to stop Purchaser
from selling Products under this Agreement, upon notice thereof, Purchaser shall
also cause such third parties to immediately stop manufacturing Products upon
written notice from GEHC.  

 

“Products” means, collectively, the products listed on Box 3, Page 1, and which,
pursuant to the terms of this Agreement, will be incorporated into and sold as a
part of the Combination Products.

 

”Territory” means those jurisdictions sert forth in Box 7, Page 1.

 

“Trademarks” means all trademarks, service marks, logos, internet domain names
and trade names, whether or not registered, and all goodwill associated
therewith, associated or used in connection with the Products (including without
limitation “GE,” “GEHC,” “General Electric”, “Amersham”, [****] and “Whatman”)
together with all other trade dress, labels, designs, markings, notices or other
means of identification which are part of or applied to any Product or its
packaging.

 

For purposes of this Agreement, except as otherwise expressly provided herein or
unless the context otherwise requires: (a) the use herein of the plural shall
include the single and vice versa and the use of the masculine shall include the
feminine; (b) the use of the term “including” or “includes” means “including
[includes] but [is] not limited to”; (c) the words “herein,” “hereof,”
“hereunder,” and other words of similar import refer to this Agreement as a
whole and not to any particular provision.  Additional terms may be defined
throughout this Agreement.

 

2.

Supply of Products; Limitations

 

2.1Subject to the terms and conditions of this Agreement, GEHC hereby appoints
Purchaser, and Purchaser hereby accepts the appointment, as a non-exclusive
re-seller of the Products, without modification, solely as part of the
Combination Products to End Users within the Field in the Territory.  

 

2.2Pursuant to Section 2.1, Purchaser may sell Combination Products
incorporating Products through its Permitted Affiliates or Permitted
Distributors and Purchaser may engage Permitted Manufacturers to
manufacture  Combination Products on behalf of Purchaser; provided that (i)
Purchaser shall be fully responsible and liable for the acts and/or omissions of
any Permitted Affiliate, Permitted Distributor or Permitted Manufacturer and
(ii) Purchaser shall cause each Permitted Affiliate, Permitted Distributor and
Permitted Manufacturer to fully comply with the terms and conditions of this
Agreement.

 

2.3 Intentionally Omitted.

 

2.4Subject to Section 4, Purchaser acknowledges that in the performance of this
Agreement one or more Affiliates of GEHC may manufacture, sell and/or deliver
the Products purchased hereunder; provided that such Affiliate shall comply with
the terms and conditions of this Agreement and GEHC shall remain liable for the
performance of any obligations hereunder by its Affiliate.

 

3.

Rights  and Limitations

 

3.1   No right or license under the Patent Rights, or otherwise, is granted to
Purchaser, any Permitted Affiliates or Permitted Manufacturers to use the
Products for any purpose other than as expressly provided herein.  In no event
shall Purchaser, its Permitted Affiliates, Permitted Distributors or any
Permitted Manufacturer (i) sell, offer for sale or otherwise distribute Products
as a stand-alone product or in connection with any product other than the
Combination Products; (ii) sell, offer for sale or otherwise distribute Products
for use outside the Field; or (iii) alter, modify, reverse engineer, decompile,
disassemble, deconstruct, improve or otherwise the Products or create any
derivative works based upon Products.

 

[****] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

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3.2Unless otherwise agreed to by the parties in writing, Purchaser will ensure
that all sales of Products shall be to End Users and under terms that prohibit
such End User’s from making, have made, modifying, selling, re-selling or
otherwise transfering or distributing Products in any manner or by any means, on
a stand-alone basis or as part of an assembly or system. For the avoidance of
doubt, Purchaser shall be free to sell Combination Products through Permitted
Distributors.

 

3.3All rights not expressly granted by GEHC hereunder are reserved to GEHC.
Without limiting the generality of the foregoing, GEHC and Purchaser expressly
acknowledge that nothing contained herein shall be construed or interpreted as a
grant, by implication or otherwise, of any rights other than the limited right
expressly granted in Section 2 and 3, either expressly, by implication or by
estoppel.

 

3.4Notwithstanding anything herein to the contrary, GEHC reserves the right to:
(i) make, use and sell Products for itself, and to grant licenses to others in
respect thereof, for any purpose whatsoever; and (ii) sell, offer for sale
and/or have sold, either by itself, its Affiliates or any other person or
entity, the Products on a stand-alone basis or in combination with other
products, instruments or devices.  

 

3.5 Intentionally Omitted.

 

4.

Change Control

 

4.1 Notwithstanding anything to the contrary contained in this Agreement, GEHC
reserves the right,  in its sole discretion, without incurring any liability to
Purchaser, its Permitted Affiliates or Permitted Distributors, exercisable upon
written notice to Purchaser to  in accordance with Exhibit 1 (i) alter the
specifications for any Product; (ii) discontinue the manufacture, purchase or
sale of any Product; (iii) commence the manufacture and/or sale of new products
having features that make any Product wholly or partially obsolete. The receipt
by Purchaser of notice from GEHC discontinuing the manufacture or sale of any
Product shall be deemed an amendment to the product specifications included in
[****].  Sufficient notice shall include via GEHC’s website, electronic mail,
fax or letter.

 

4.2In addition to the Last Time Purchase, GEHC shall use reasonable efforts to
fill all pending orders (if any) from Purchaser (and its Permitted Affiliates)
for any such altered or discontinued Product that has been accepted by GEHC, but
not yet shipped, on the date GEHC gives notice pursuant to this Section 4.1.

 

5.

Ordering; Delivery; Forecasts

 

5.1Purchaser (directly or through a Permitted Affiliate) will order Products
from GEHC under the terms and conditions of sale contained in this Agreement.
Only Purchaser and its Permitted Affiliates may submit a purchase order to GEHC
for Products. When used in this Section 5, “Purchaser” shall mean Purchaser,its
Permitted Affiliates.

 

5.1.1 GEHC shall not have any obligation to sell or provide Products to any
Permitted Affiliate that is or becomes a competitor of GEHC, either directly or
indirectly.

 

5.1.2Purchaser acknowledges that this Agreement covers the purchase of Product
by Purchaser,its Affiliates within the Territory only.

 

 

5.2Each time Purchaser wishes to purchase Products from GEHC, it shall submit a
purchase order to GEHC.  Such purchase orders shall be submitted in writing by
means and in a form as specified from time to time by GEHC.  Each purchase order
shall specify (i) the purchase order number; (ii) the [****] number of Products;
(iii) the quantities of Products ordered; and (iv) the shipping address.

 

5.3Upon receipt of a purchase order in accordance with this Agreement, GEHC
shall send an order acknowledgement within 24-hours after entering the order.
GEHC shall fulfill purchase orders to the extent the volume is equal to the
volumes contained in a binding forecast delivered by Purchaser and shall use
reasonable efforts fo fulfill any orders for Product placed by Purchaser that
are not covered by the binding forceast out of GEHC’s available inventory at
such time .All purchase orders are subject to (i) GEHC’s on-going credit review
and approval and (ii) GEHC’s on-going determination that Purchaser and the
proposed purchase order comply with all applicable laws and regulations. In the

event that GEHC rejects a purchase order hereunder, the parties shall promptly
discuss the reasons for such rejection and use reasonable good faith efforts to
resolve the reason for rejection.  In addition, in the event that Purchaser
delivers a request to amend an accepted purchase order, GEHC agrees to use good
faith efforts to amend the purchase order.

 

5.4Purchase orders from Purchaser to GEHC shall be placed through GEHC’s
customer service in the region for which the purchase order has been placed
(i.e. Purchaser’s orders for the United States shall be through GEHC’s US
customer service, Purchaser’s orders for the United Kingdom shall be through
GEHC’s customer service covering the United Kingdom, etc.). GEHC shall have no
obligation to fulfill orders placed in the wrong region.

 

5.5In the event that any terms or conditions in a purchase order conflict with,
or are in addition to, the terms and conditions of this Agreement, the terms and
conditions of this Agreement shall control and such conflicting or additional
terms in purchase order shall have no force or effect. No modification or waiver
of the terms of this Agreement will be effective unless in writing explicitly
amending this Agreement and signed by both parties.  Orders will be deemed
accepted by GEHC upon Purchaser’s receipt of GEHC’s order confirmation with any
modifications to requested quantities or delivery dates on Purchaser’s purchase
order made by GEHC on the front of the order confirmation as the final agreement
between GEHC and Purchaser.

 

5.6GEHC will select the method of shipment and the carrier to be used for
shipment of Products ordered hereunder All Products shipped hereunder shall be
delivered [****] in the United States, Puerto Rico and Canada, and [****] in any
other country. It is hereby agreed that [****] delivery terms are not supported
by GEHC. Partial deliveries of Product hereunder shall be permitted.

 

5.7Risk of loss and full legal and equitable interest and title in and to
Products, shall pass to Purchaser upon delivery [****]. GEHC will not be
responsible for any loss or damage to Products following delivery [****].

 

5.8Products cannot be returned without prior written authorization by
GEHC.  Except for Products returned pursuant to Sections 5.10 and 12.4, a fee
may be applied to shipments returned for exchange or credit.

 

5.9GEHC will use all reasonable endeavors to deliver Products on the agreed
delivery date and will use all reasonable endeavors to avoid delay in delivery
on the notified delivery dates. Failure to deliver by the specified date will
not be a sufficient cause for cancellation, nor will GEHC be liable for any
direct, indirect, consequential or economic loss due to delay in delivery.

 

5.10Purchaser shall notify GEHC within [****] business days in writing of any
short delivery or defects reasonably discoverable on careful
examination.  GEHC’s sole obligation shall be, at its option, (i) in the case of
defective Products, to replace, repair or provide Purchaser with a refund for
such Products, in accordance with Section 12.4 or (ii) in the case of short
delivery, at Purchaser’s option, refund the purchase price actually paid for any
undelivered Products or promptly deliver the remaining Products.

 

5.11 If Purchaser fails to accept delivery of any Products within [****]
business days after receiving notice from GEHC that Products are ready for
delivery, GEHC may dispose of or store such Products at Purchaser's reasonable
expense.

 

5.12Where delivery of any Product requires an export license or other
authorization before shipment, GEHC shall not be responsible for such license or
authorization, or any loss, liability, fee or expense in any way connected
theretoprovided that GEHC agrees to reasonably cooperate with Purchaser as
necessary to provide relevant Product information .

 

5.13Each year during the term of this Agreement, Purchaser shall have the
obligation to purchase the greater of the Minimum Purchase Requirement or the
binding forecasted amount. If Purchaser fails to purchase the greater of the
Minimum Purchase Requirement for the binding forecasted amount in any applicable
year set forth, then following the conclusion of such period, [****].

 

5.14Purchaser agrees that, each quarter during the term of the Agreement, it
will provide GEHC with its forecast of the quantity and required delivery date
of the Products that Purchaser will require to purchase from GEHC during the
[****] following months. Prior to the beginning of each calendar quarter,
Purchaser shall deliver a purchase order for the quantity of Product required by
Purchaser in the first three months of the forecaset and the first [****] months
of each such forecast shall be binding on Purchaser and the [****] following
months shall be

 

[****] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

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non-binding. For clarification, no Products will be shipped to Purchaser until a
relevant purchase order is received and processed by GEHC as set forth herein.
If Purchaser's actual needs for Products exceeds the binding forecast, GEHC
shall use commercially reasonable efforts to supply Purchaser with the excess
Product, but shall bear no liability to Purchaser if GEHC cannot supply such
excess quantity.

 

5.15    Each year during the term of this Agreement, Purchaser shall have the
option to place an annual blanket order covering Purchaser’s requirements for
Products during such year.

 

6.

Pricing; Payments

 

6.1The price of Products will be in accordance with GEHC’s current list price
minus any discount in accordance with Schedule 1. A quotation stating the exact
purchase price to be paid by Purchaser to GEHC will be provided separately by
GEHC.  The quote will be reissued annually by GEHC no later than December
1.  The prices are based on use of the Products solely in accordance with the
requirements of this Agreement.  GEHC will deliver an invoice to Purchaser in
connection with each delivery of Products hereunder.  Purchaser will timely pay
the purchase price in accordance with the terms set forth herein.

 

6.2All payments hereunder shall be due and payable to GEHC [****] days from the
date of invoice issued by GEHC.  In the event of late payment GEHC, after notice
to Purchaser, reserves the right to (i) suspend deliveries and/or cancel any of
its outstanding obligations; and/or (ii) charge interest at the higher of (A)
[****] per annum or (B) the highest rate per annum permitted under applicable
law, in each case calculated on a daily basis from the date such amount first
becomes due until such amounts are paid in full. Purchaser shall reimburse GEHC
for reasonable costs (including attorney’s fees) relating to collection of any
unpaid amounts. GEHC may set-off any outstanding amounts due to GEHC by
Purchaser against any and all payments due by GEHC to Purchaser hereunder.  

 

6.3All payments due and payable by Purchaser to GEHC under this Agreement are
exclusive of any Value Added Tax (“VAT”), sales and use tax, goods and services
tax and similar indirect taxes. In the event that any VAT, sales and use tax,
goods and services tax and similar indirect taxes are properly due under any
applicable law, regulation or otherwise, this shall be charged by GEHC in
addition to any other payments due hereunder and shall be payable by Purchaser
on receipt of a valid invoice issued by GEHC, unless Purchaser provides GEHC
with valid exemption documentation allowing GEHC not to charge the relevant
indirect taxes. In addition and in the case of US domestic transactions only (i)
in the event GEHC is assessed taxes, interest and penalty by any taxing
authority, Purchaser agrees to reimburse GEHC for any such taxes, including any
interest or penalty assessed thereon; and (ii) each party is responsible for any
personal property or real estate taxes on property that the party owns or
leases, for franchise and privilege taxes on its business, and for taxes based
on its net income or gross receipts..

 

6.4The price payable by Purchaser for Product hereunder does not include the
cost of handling, freight, shipping, packaging of Products for shipment,
charges, levies, duties, assessments and other fees of any kind imposed by any
governmental authority, or the cost of insurance from the time the Product
leaves GEHC’s premises. Such costs shall be invoiced to Purchaser who shall pay
such costs together with the prices hereunder.

 

7.

Records and Audits

 

7.1Purchaser shall at all times during the term of this Agreement, and for a
period of five (5) years thereafter, keep true and accurate records relating to
its sale of Combination Products in sufficient detail to enable GEHC to
determine Purchaser’s, Permitted Affiliates,’ Permitted Distributors’ and
Permitted Manufacturers’ compliance with this Agreement.  Such records shall
also include full-lot traceability by product serial number to enable GEHC to
identify all End Users of the Products sold by Purchaser, its Permitted
Affiliates and Permitted Distributors.  In the event that GEHC is required to,
or determines in its sole discretion to, conduct a product recall or withdrawal
of the Products, GEHC shall promptly notify Purchaser and Purchaser will
reasonably cooperate with GEHC in connection with such recall or withdrawal, as
required by  law.  GEHC agrees that, in the event of a recall, it shall
reimburse Purchaser for the cost of returning or reasonable costs for destroying
any Products and GEHC shall promptly replace the Product subject to the recall
or reimburse Purchaser for the cost thereof.

 

7.2GEHC shall have the right, at its own expense, to appoint an independent
auditor reasonably acceptable to Purchaser to review Purchaser's and/or its
Permitted Affiliates’ records that are necessary to verify compliance with this
Agreement.  For avoidance of doubt, the scope of such audit shall include all
records required to be maintained under Section 7.1. Such audits shall be
performed upon reasonable advance notice during normal business hours and may
not be called for more frequently than once in any calendar year.  The foregoing
restriction is hereby waived by if any such audit reveals that Purchaser, its
Permitted Affiliate or Permitted Distributor has failed to comply with the terms
and conditions of this Agreement.

 

7.3 GEHC shall permit an agreed upon third party, upon reasonable prior notice
and GEHC’s scheduled availability and during normal business hours, to view the
manufacturing operations for and conduct audits of GEHC’s production and quality
control procedures for the purchased Product and GEHC records as necessary to
determine conformance with the terms of this Agreement. However, GEHC shall not
be obliged to share information which constitutes proprietary Product
information or secret manufacturing know-how.  Purchaser audits that are not
based on breaches or alleged breaches of this Agreement and are not required by
law or a governmental agency in excess of one (1) per calendar year will be
mutually agreed upon by Purchaser and GEHC.  Upon the completion of any such
audit, an exit meeting will be held with representatives from GEHC and Purchaser
to discuss significant audit observations. Purchaser will provide a written
report of all observations within thirty (30) days to GEHC. Within 30 days of
the audit report receipt, Purchaser will provide written response to all
findings that describes corrective action to be implemented as appropriate. A
Non-Disclosure Agreement is required for each audit and Purchaser will assume
all costs associated with any such audits.

 

8.

Trademark

 

8.1Unless listed in Schedule 3, Purchaser shall have no right to use any
Trademarks in connection with Combination Products whatsoever.

 

8.2Purchaser acknowledges and agrees that:

 

8.2.1GEHC and/or its Affiliates own of all Trademarks;

 

8.2.2It is not contemplated that Purchaser will acquire any rights in the
Trademarks, but in all cases, any rights Purchaser may acquire in any Trademark
shall be assigned to GEHC or its designee absolutely and Purchaser agrees to
enter into any and all documents necessary to effectuate such assignment; and

 

8.2.3Except as expressly set forth herein, Purchaser does not have any rights or
any title whatsoever in or to GEHC’s technology, trade name or in or to any of
the Trademarks.

 

9.

Other Proprietary Rights; Infringement

 

9.1  Subject to Section 3.1, all right, title and interest worldwide in the
Intellectual Property Rights in or associated with the Products shall at all
times remain vested solely and exclusively in GEHC and its Affiliates.

 

9.2  GEHC represents and warrants that the Products do not infringe the
intellectual property rights of any third parties.  

 

10Compliance

 

10.1  GEHC represents and warrants that it shall comply with all applicable laws
and regulations in connection with the manufacturing, use, sale, shipment, and
otherwise, of the Products.

 

10.2Purchaser represents and warrants that it shall comply with all applicable
laws and regulations in connection with the sale and use of Combination
Products, including, without limitation all applicable laws and regulations
issued by the country of origin, the U.S. government, the United Nations or
other similar international organization regarding export and/or import of
Products as part of Combination Products.

 

10.3Purchaser shall not pay, offer or promise to pay, or authorize the payment
directly or indirectly through any person or firm, anything of value (in the
form of compensation, gift, contribution or otherwise) to:

 

10.3.1any person or firm employed by or acting for or on behalf of any customer,
whether private or governmental, for the purpose of inducing or

 

[****] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

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rewarding any favorable action by the customer in any commercial transaction or
in any governmental matter; or

 

10.3.2any governmental official, political party or official of such party, or
any candidate for political office, for the purpose of inducing or rewarding
favorable action or the exercise of influence by such official, party or
candidate in any commercial transaction or in any governmental matter.

 

11Confidentiality

 

11.1During the term of this Agreement and a period of five (5) years thereafter,
Purchaser and GEHC agree to keep confidential and not to disclose any
Confidential Information of or about the other party to a third party and not to
use such Confidential Information other than for the purpose of this Agreement.

 

11.2The undertakings of non-disclosure and non-use in this Section shall not
apply to:

 

11.2.1  Information that at the time of disclosure or subsequently is published
or otherwise generally available to the public other than through any act or
omission on the part of the recipient party; or

 

11.2.2  Information that was in the possession of the recipient party at the
time of disclosure, as evidenced by the recipient party’s written records; or

 

11.2.3 Information acquired from a third party who has the lawful right to make
such disclosure as evidenced by the recipient party’s written records; or

 

11.2.4  Information that is independently developed by the recipient party
without reference to or use of the materials comprising, or reverse engineering
involving, the Confidential Information disclosed under this Agreement as
evidenced by the recipient party’s written records; or

 

11.2.5  Information that is required to be disclosed by the recipient party
pursuant to a legally enforceable order, direction or other regulation but any
such disclosure shall be only so far as necessary to give effect thereto.

 

11.3Each party shall exercise all reasonable precautions to prevent the
disclosure of Confidential Information of the other party by its employees or
representatives, and in any event shall maintain with respect to such
Confidential Information a standard of care which is no less than that standard
which Purchaser maintains to prevent the disclosure of its own confidential
information.

 

11.4Upon termination of this Agreement, each party agrees to return at once to
other party, without copying, all originals and copies of all materials (other
than this Agreement) containing any Confidential Information.

 

12Warranty; Disclaimer

 

12.1Each party warrants and represents to the other that:

 

12.1.1 The execution, delivery and performance of this Agreement by it does not
conflict with or contravene its certificate of incorporation or by-laws, nor
will the execution, delivery or performance of this Agreement by it conflict
with or result in a breach of, or entitle any party thereto to terminate, any
agreement or instrument to which it is a party, or by which any of its assets or
properties is bound.

 

12.1.2This Agreement has been duly authorized, executed and delivered by it and
constitutes a legal, valid and binding agreement of such party, enforceable
against it in accordance with its terms.

 

12.1.3It has the legal right and authority to enter into, grant the rights
hereunder, and perform its obligations under this Agreement.

 

12.2Neither party shall do any act or fail to do any act, if such act or failure
to act would materially harm the other party, including without limitation,
misrepresent, misuse or misapply the Product.  Each warranty given by GEHC in
this Section 12 is given solely to, and may only be relied upon by, Purchaser
and, subject to GEHC’s indemnity obligations, shall not extend to any End User,
subsequent purchaser, transferee or assignee of any Product.

 

12.3Subject to GEHC’s indemnity obligations, Purchaser shall be fully and
exclusively responsible for all warranties given by Purchaser to End Users,
whether or not such warranties are greater than or in addition to the express

warranties set forth in Section 12.4 of this Agreement. Purchaser agrees to
indemnify, defend and hold harmless GEHC and its Affiliates and representatives
from and against any and all claims by any person, whether or not such person is
an End User, arising from, relating to, or in connection with any warranty given
by Purchaser, whether express or implied.

 

12.4GEHC warrants that the Products provided hereunder will conform to the
specifications included in GEHC’s product [****] in all material respects during
at the time of shipment..  All warranty claims on the Products’ under this
Section 12.4 must be made within ninety (90) days of Purchaser’s and/or the
relevant Permitted Affiliate or Permitted Manufacturer  receipt of
Products.  GEHC’s sole liability and Purchaser’s exclusive remedy for a breach
of this warranty is limited to repair of, replacement of, or refund of the
purchase price actually paid by Purchaser for such Products, at the sole option
of GEHC.  Notwithstanding the expiration of the applicable product warranty set
forth above, in the event that GEHC becomes aware that any applicable lot of
Product sold to Purchaser hereunder does not conform to its Specifications, GEHC
shall promptly notify Purchaser.

 

12.5EXCEPT AS EXPRESSLY PROVIDED HEREIN, GEHC MAKES NO REPRESENTATIONS OR
WARRANTIES, EXPRESS, IMPLIED OR STATUTORY (INCLUDING WITHOUT LIMITATION, ANY AND
ALL WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE).  PURCHASER SHALL NOT HAVE THE RIGHT TO MAKE OR EXTEND, AND SHALL TAKE
REASONABLE MEASURES TO ENSURE THAT NEITHER IT, ITS EMPLOYEES NOR ANY PERMITTED
AFFILIATE MAKE ANY SUCH WARRANTY OR REPRESENTATION ON BEHALF OF GEHC TO ANY END
USER OR OTHER THIRD PARTY.

 

12.6Except for the indemnification obligations set forth herein, GEHC shall have
no liability under the warranties contained in this Section 12 arising from: (i)
the use of the Products in combination with any software, tools, hardware,
equipment, supplies, accessories or any other materials or services not
furnished by GEHC or recommended in writing by GEHC other than as a Combination
Product;  (ii) fair wear and tear or; (iii) fraud, willful damage or gross
negligence of Purchaser or any of its Permitted Affiliates, Permitted
Manufacturers or representatives; (iv) shipping, storage or working conditions
after GEHC’s delivery of the Products to the common carrier other than in
accordance with GEHC instructions;  (v) failure to follow GEHC's use
restrictions, recommendations or instructions; (vi) any alteration,
modification, repair or enhancement of the Products by Purchaser or any third
party, without GEHC's prior written consent;  (vii) any misuse of the Products
or Purchaser’s use of the Products not in accordance with specifications; (viii)
any allegation that Purchaser’s use of Products infringes the Intellectual
Property Rights of any other Person; (ix) subject to Section 15, any Products
damaged or lost as a result of a force majeure event; or (x) any Products, if
the price payable for such Product has not been paid in full in accordance with
the terms of this Agreement.

 

13Indemnity

 

13.1  Purchaser Indemnity.  Purchaser agrees to indemnify, defend and hold
harmless GEHC, its Affiliates, customers, successors and assigns, as well as
each of their respective directors, officers, shareholders, employees and
advisors (collectively, the "GEHC Indemnitees"), from and against any and all
claims, demands, losses, liabilities, expenses, or damages (including
investigative costs, court costs and attorneys’ fees) that any GEHC Indemnitee
may suffer, pay, or incur as a result of, or in connection with:

 

13.1.1any breach by Purchaser, its Permitted Affiliates, Permitted Distributors,
Permitted Manufacturers, employees or agents of any of Purchaser’s obligations
or representations and warranties set forth in this Agreement;

 

13.1.2any fraud, gross negligence or intentional misconduct  by Purchaser, its
Permitted Affiliates, Permitted Distributors, Permitted Manufacturers, employees
or agents in connection with this Agreement

 

13.1.3 any claims (including, without limitation, claims of infringement or
alleged infringement by the Combination Product which is not solely related the
infringement or alleged infringement by the Product itself, death, personal
injury, illness or property damage caused by the Combination Product not related
to the performance of the Product) arising out of the exploitation of the rights
granted under this Agreement or otherwise arising out of use, sale or
distribution of the Products or Combination Products by Purchaser, its Permitted
Affiliates, Permitted Distributors, Permitted Manufacturers, employees or agents
hereunder; or

 

[****] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

6 of 13

--------------------------------------------------------------------------------

 

 

13.1.4  representations, warranties or statements made by Purchaser, its
Permitted Affiliates, Permitted Distributors, Permitted Manufacturers employees
or agents in regard to the Products, which are not specifically authorized by
GEHC herein or otherwise in writing.

 

13.2 Exceptions to Purchaser Indemnity.  Notwithstanding anything to the
contrary contained herein, Purchaser shall not be obligated to indemnify, defend
or hold harmless GEHC Indemnitees if such claim arises out of, or results from,
in whole or part, (i) the fraud, gross negligence or intentional misconduct, or
(ii) violation of applicable laws by any GEHC Indemnitees.

 

13.3GEHC Indemnity.  GEHC agrees to indemnify, defend and hold harmless
Purchaser, its Affiliates, customers, successors and assigns, as well as each of
their respective directors, officers, shareholders, employees and advisors
(collectively, the "Purchaser Indemnitees"), from and against any and all
claims, demands, losses, liabilities, expenses, or damages (including
investigative costs, court costs and attorneys’ fees) that any Purchaser
Indemnitee may suffer, pay, or incur as a result of, or in connection with:

 

13.3.1any breach by GEHC, its Affiliates, employees or agents of any of GEHC’s
obligations or representations and warranties set forth in this Agreement;

 

13.3.2any fraud, gross negligence or intentional misconduct  by GEHC, its
Permitted Affiliates, Permitted Distributors, employees or agents in connection
with this Agreement; or

 

13.3.3any claims (including, without limitation, claims of infringement or
alleged infringement related to the Product itself and not related to the
Combination Product , death, personal injury, illness or property damage)
arising out of the sale or distribution of the Products by GEHC under this
Agreement.

 

13.4 The indemnified party shall promptly notify the indemnifying party of any
and all such claims for which it seeks indemnification hereunder.

 

14Term and Termination

 

14.1Unless otherwise terminated as provided for in this Agreement, this
Agreement shall become effective as of the Effective Date and remain in effect
for a period of three (3) years and shall automatically renew for additional
successive two (2) year periods thereafter (each, a “Renewal Term” and together
with the Initial Term, the “Term”) up to eight (8) years unless terminated in
accordance with the terms of this Agreement.

 

14.2If either GEHC or Purchaser (a) fails to materially perform any of its
obligations under this Agreement, or (b) materially breaches any representation
or warranty made by it herein, then the non-defaulting party shall have the
right to terminate this Agreement if such default or breach shall not have been
cured within [****] days after the non-defaulting party has given written notice
to the defaulting party specifying the nature of such default or
breach.  Notwithstanding the foregoing, in the event that Purchaser fails to
make payment for any amount due and payable hereunder when due, GEHC shall have
the right to terminate this Agreement [****] days after written notice from GEHC
of its intent to terminate for non-payment if such payment is not made within
such [****] day period or if such occurance of late payment occurs [****] times
within a rolling [****] months period.    

 

14.3 This Agreement may be terminated immediately by either party in the event
of (i) the other party’s insolvency, receivership, or voluntary or involuntary
bankruptcy, (ii) an assignment by the other party for the benefit of creditors;
or (iii) any substantial part of the other party’s property being or becoming
subject to any levy, seizure, assignment or sale for or by any creditor or
governmental agency without being released or satisfied within thirty (30) days
thereafter.

 

14.4. This Agreement may be terminated by GEHC upon written notice to Purchaser
upon Change of Control of Purchaser if (i) the proposed acquirer, assignee or
transferee is verified to be on U.S. government embargo lists, lists of known
parties and other watch lists and would cause GEHC to be in violation of its
compliance program; (ii) if the proposed acquirer, signee or transferee is a
direct competitor of GEHC in producing or selling the Product on a standalone
basis (and not solely as part of a test or kit) as also referenced in Section
5.1.1 and  GEHC has a commercially reasonable concern with the Change of Control
resulting from concerns with compliance with local, state or federal laws and

regulations, or indication of any state or federal investigation or any other
financial or legal viability concern relating to the proposed acquirer, signee
or transferee, provided that the fact that the acquirer, assignee or transferee
may compete in certain markets outside the manufacture or sale of the Product on
a standalone basis is not a reason for termination under this Agreement.

 

14.5This Agreement may be terminated by either party without cause upon not less
than [****] months’ prior written notice. In the event of such termination,
Purchaser acknowledges that it has full financial responsibility for any
undisputed costs of Products that are included in the binding portion of the
forecast and that are held in GEHC’s inventory, work in progress (WIP) and any
unique raw material used to manufacture Products and that payment shall be
rendered by Purchaser within [****] days of the delivery by GEHC to Purchaser of
a detailed invoice setting forth in detail the costs of each such item.

 

14.6  Last Time Purchase.  Upon delivery of notice of termination for any
reason, except for cause under Sections 14.2, 14.3 or 14.4, GEHC shall fill all
pending orders (if any) from Purchaser (and its Permitted Affiliates and
Permitted Manufacturers) on the date either party gives notice of termination
and GEHC shall accept a final order from Purchaser for Product with the
specifications applicable to the last version of the Product acceptable to
Purchaser, so long as the order is made within [****] days following receipt of
notice of termination for a quantity of Product sufficient to meet Purchaser’s
requirements for the [****] month period following the date of termination;
provided, however, that such order shall not exceed [****] times the amount of
the most recent [****] months of purchases delivered by GEHC to Purchaser
hereunder (the ”Last Time Purchase”).  Such Last Time Purchase may include one
or more than one lot of the Product.  

 

14.7  Upon the termination of this Agreement:

 

14.7.1In the event that this Agreement is terminated by GEHC for cause under
Sections 14.2, 14.3 or 14.4, Purchaser shall remain responsible to make any
shortfall payment due and that any undisputed payment therefor shall be rendered
by Purchaser within [****] days of the date of invoice to Purchaser detailing
such shortfall.

 

14.7.2In the event of termination for any reason other than for cause by GEHC
pursuant to Sections 14.2, 14.3 or 14.4,  Purchaser, its Permitted Affiliates
and Permitted Distributors may continue to sell or offer for sale Combination
Products which (i) are in Purchaser’s inventory on the termination or (ii) which
are supplied on or after the termination date (the “Sell Off Period”).  For
avoidance of doubt, Purchaser’s, its Permitted Affiliates’ and Permitted
Distributors’ sale of Combination Products during the Sell Off Period shall be
made in compliance with the terms and conditions of this Agreement.  .  In the
event that this Agreement is terminated by GEHC pursuant to Sections 14.2, 14.3
or 14.4, Purchaser, its Permitted Affiliates and Permitted Distributors shall
immediately destroy all remaining inventory of Products and such destruction
shall be certified to GEHC in writing by a member of Purchaser’s senior
management or other executive officer within five (5) business days following
such destruction.

 

14.7.3Subject to Section 6.2, any purchase order placed by Purchaser and
accepted by GEHC prior to the effective date of termination of this Agreement
may only be cancelled by Purchaser with the prior written consent of GEHC.

 

14.7.4Immediately upon termination for any reason, Purchaser shall, and shall
cause all of its Permitted Affiliates, Permitted Distributors and Permitted
Manufacturers to, (i) cease using the Trademarks (except as necessary during an
applicable Sell Off Period) and (ii) return all Confidential Information to GEHC
and GEHC shall return all Confidential Information to Purchaser.  

 

14.7.5Termination or expiration of this Agreement shall not relieve either party
of its obligations hereunder that are intended to survive termination and each
party shall retain all legal and equitable remedies after such termination or
expiration.  The rights and obligations in the following clauses shall survive
any termination of this Agreement to the degree necessary to permit their
complete fulfillment or discharge: 6, 10, 11, 12, 13.6, 13.7, 15, 17.4 and 17.5.

 

14.8For the avoidance of doubt, the acceptance of any purchase order from, or
the sale of any Products to, Purchaser after the expiration or termination of
this Agreement shall not be construed as a renewal or extension, nor as a waiver
of expiration or termination, of this Agreement.  In the absence of a written

 

[****] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

7 of 13

--------------------------------------------------------------------------------

 

agreement between the parties relating to the purchase of such Products, all
such transactions shall be individually governed by GEHC’s standard terms and
conditions governing such products in place from time to time which can be found
at the following website https://www.gelifesciences.com/en/us/legal

 

15Force Majeure

 

The obligations of either party hereunder shall be excused or suspended to the
extent performance is prevented or delayed by any future condition, which (i) is
beyond the reasonable control, and without the fault or negligence, of the party
affected thereby, (ii) was not foreseeable by such party at the time this
Agreement was entered into, and (iii) could not have been prevented by such
party taking reasonable steps. Such conditions shall include but not be limited
to war, terrorism, mobilization, riots, fire, explosion, flood, insurrection,
embargo, currency restriction, shortage of transport, general shortage of
material and acts or omissions of governments in their sovereign capacity.

 

The party invoking Section 15.1 hereof shall, within seven (7) days after
commencement of the condition there mentioned, give written notice thereof, and
of the anticipated consequences thereof, to the other party. Within seven (7)
days after termination or cessation of such condition, the affected party shall
give further written notice to the other party detailing the actual results of
such condition.

 

In the event of any such condition, the party affected thereby shall take all
reasonable measures to mitigate and minimize the effect of the condition, and to
resume as promptly as possible the diligent performance of its obligations under
this Agreement. Nothing in this section shall, however, obligate either party to
settle strikes or other labor disputes except on terms and conditions, which it,
in the exercise of its sole discretion, deems appropriate.

 

16Governing Law and Disputes

 

This Agreement shall be governed by, and construed and enforced in accordance
with, the laws of the State of New York, without regard to conflict of law
principles; except that, any matter touching or concerning intellectual property
rights shall be governed by the laws of the jurisdiction in which such rights
were granted. In no event shall this Agreement be governed by the UN Convention
on Contracts for the International Sale of Goods

 

Any dispute, controversy, or claim relating to this Agreement ("Dispute") shall
be resolved first through good faith negotiations between the parties. If the
Dispute cannot be resolved through good faith negotiation, then the parties
agree to submit the Dispute to mediation. The requirement of mediation and
negotiation may be waived upon mutual written consent of Purchaser and GEHC.

 

If the Dispute is not otherwise resolved through negotiation or non-binding
mediation within a reasonable time period (such time period not to exceed [****]
days from the date the Dispute was first notified by either party to the other),
either party may submit the Dispute exclusively to the courts of the State of
New York.

 

THE PARTIES EXPRESSLY WAIVE AND FOREGO ANY RIGHT TO A TRIAL BY JURY.

 

17Notices

 

All notices and other communications hereunder shall be in writing.  All notices
hereunder shall be delivered personally, or sent by national overnight delivery
service or postage pre-paid registered or certified U.S. mail, and shall be
deemed given:  when delivered, if by personal delivery or overnight delivery
service; or if so sent by U.S. mail, [****] business days after deposit in the
mail, and shall be addresse or to such other place as either party may designate
by written notice to the other in accordance with the terms hereof.

 

18Licenses, Permits and Export Control

 

18.1Each party shall apply and obtain from any appropriate governmental
authorities all relevant licenses, permits and approvals necessary for the
performance of this Agreement and shall bear all related costs arising
therefrom. Neither party shall be responsible for the adverse consequences
caused by the other party's failure in obtaining (in a timely manner) the
aforementioned licenses/permits, and the non-defaulting Party shall be entitled
to claim its losses (if any) from the defaulting party.

 

18.2Purchaser and GEHC hereby agree that they shall not, except as

expressly permitted by applicable laws, make any disposition by way of
transshipment, re-export, diversion or otherwise, of U.S. origin goods and
technical data, or the direct product thereof, supplied by the GEHC hereunder.
Purchaser hereby certifies that Products, information or assistance furnished by
GEHC or its Affiliates under this Agreement shall not be used in the design,
development, production, stockpiling or use of chemical, biological, or other
weapons either by the Purchaser or by any entity acting on the Purchaser's
behalf.

 

18.3Purchaser shall not export the Products or any information or documents
provided hereunder within or outside of the Territory without the requisite
export license from the relevant body of the United Nations or other similar
international organization, the United States Government, the European Union,
the country of origin or the original country of export. The requirement to
obtain a license may vary depending on the country of destination, the end user,
the end use and other factors. Upon request from GEHC, Purchaser shall furnish
GEHC with copies of all documents relating to such export.

 

18.4The obligations of the parties to comply with all applicable export control
laws and regulations shall survive any termination, or discharge of any other
contract obligations.

 

19Miscellaneous

 

19.1Amendments and Modifications. No provision of this Agreement may be amended,
modified or otherwise changed, other than by an instrument in writing duly
executed on behalf of the parties of this Agreement.

 

19.2Successors and Assignment. This Agreement and the rights granted herein
shall inure to the benefit of the parties hereto and their respective successors
and permitted assigns.

 

19.2.1Neither party hereto shall assign or transfer any of its rights,
privileges or obligations hereunder without the prior written consent of the
other party hereto, except that, subject to Section14.4, m either party may
assign this Agreement without consent (i) to one or more of its Affiliates or
(ii) to any acquirer of or successor to that portion of its business to which
this Agreement relates.

 

19.3Entire Agreement; Counterparts. This Agreement, together with any and all
Schedules attached hereto, constitute the full understanding and the entire
agreement between the parties as to its subject matter and supersedes any and
all prior agreements, understandings and representations (whether oral or
written) between the Parties with respect to the subject matter of this
Agreement. 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.  

 

19.4Limitation of Liability.  

 

19.4.1IN NO EVENT WILL EITHER PARTY BE LIABLE UNDER THIS AGREEMENT FOR ANY
INCIDENTAL, INDIRECT, SPECIAL, CONSEQUENTIAL (INCLUDING BUT NOT LIMITED TO LOST
PROFITS, LOST DATA, LOST BUSINESS OPPORTUNITY, LOSS OF GOODWILL OR LOST USE) OR
PUNITIVE DAMAGES REGARDLESS OF THE FORM OF ACTION, WHETHER CONTRACT, TORT
(INCLUDING NEGLIGENCE), STRICT PRODUCT LIABILITY OR OTHERWISE, EVEN IF SUCH
PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

 

19.4.2The total liability of GEHC for any damages incurred under or in
connection with this Agreement whether in contract, tort (including negligence),
statute or otherwise will, to the extent permissible by law, not exceed an
aggregate dollar amount equal to the sales of the applicable Products to
Purchaser under this Agreement during the immediately preceding [****] month
period.

 

19.5Insurance. Purchaser shall obtain and maintain appropriate coverage of
general liability, product liability, and public liability insurance in the
amount of no less than [****] Dollars (US$[****]) to protect GEHC and its
respective trustees, officers, employees, attorneys and agents under the
indemnification provided hereunder.  GEHC shall be provided appropriate
certificates of insurance there under upon request to Purchaser

 

19.6Equitable Remedies.  The parties hereto agree that irreparable harm would
occur in the event of a breach of any of the provisions of this Agreement and
that monetary damages alone may be an inadequate remedy for any such breach
because of the difficulty of ascertaining and quantifying the amount of

 

[****] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

8 of 13

--------------------------------------------------------------------------------

 

damage that may be suffered in any such event.  Accordingly, the parties hereby
agree that each party shall be entitled to specific performance and injunctive
or other equitable relief as a remedy for such breach or threatened breach and
each party hereby waives any requirement for the security or posting of any bond
in connection with such remedy.  Such remedy shall be in addition to, and not in
lieu of, any other rights and remedies available at law or equity.

 

19.7Relationship. GEHC and Purchaser each acknowledge that they shall be
independent contractors and that the relationship between the two parties shall
not constitute a partnership, joint venture or agency. Except as expressly
provided herein, 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 written consent of such other
party.  

 

19.8Severability. The invalidity or unenforceability of one or more provisions

of this Agreement shall not affect the validity or enforceability of any of the
other provisions hereof, and this Agreement shall be construed in all respects
as if such invalid or unenforceable provisions were omitted.

 

19.9 Waiver. The failure of either party to insist upon the performance of any
of the terms of this Agreement or to exercise any right hereunder shall not be
construed as a waiver or relinquishment of the future performance of any such
term or the future exercise of such term by reason of such future events or
events not previously insisted upon.

 

19.10Publicity.  Except to the extent required by applicable law, any
press-release or other public announcement or statement regarding the existence
of this Agreement, or any of its terms or conditions, shall be subject to the
other party’s written prior approval.

 

 

[****] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

9 of 13

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Schedule 1

PRICING

 

[****]

[****]

[****]

[****]

[****]

[****]

[****]

[****]

[****]

[****]

[****]

[****]

 

 

 

 

 

[****] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

10 of 13

--------------------------------------------------------------------------------

 

Schedule 2

 

SPECIFICATIONS

 

 

 

[****]

 

[****]

[****]

[****]

 

 

 

[****]

[****]

[****]

 

 

 

[****]

[****]

[****]

 

 

 

[****]

[****]

[****]

 

 

 

[****]

[****]

[****]

 

 

 

[****]

[****]

[****]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[****] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

11 of 13

--------------------------------------------------------------------------------

 

 

 

Schedule 3

 

LICENSED TRADEMARKS

 

NONE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[****] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

12 of 13

--------------------------------------------------------------------------------

 

Exhibit 1

 

CHANGE CONTROL PROCESS

 

As a supplier of products to the biopharmaceutical industry and products often
used in a GMP environment, Supplier acknowledges that Change Control is a
critical process in the quality management system and necessary to fulfill the
obligations to supply products with a consistent quality to its customers.

 

The purpose of this Exhibit is to provide an overview of the change control
process for the Product(s) identified on Page 1 Box 3 herein.

 

 

1.

Changes for which notification is given prior to implementation:

 

 

•

Change in label and/or primary packaging material

 

•

Change of company name

 

 

2.

Changes for which notification is given a minimum of 30 days prior to
implementation:

 

 

•

Change to shelf life or storage conditions

 

•

Change to [****] number

 

•

Change of analytical specification limit within current limits

 

•

Changes to Certificate of Analysis (not related to specifications)

 

 

3.

Changes for which notification is given a minimum of 3 months prior to
implementation:

 

 

•

Change of critical raw material

 

•

Change regarding animal origin of raw material

 

•

Change to a different test method (related to existing release specification)

 

•

Elimination of test method

 

•

Change of analytical specification - outside of current limits

 

 

4.

Changes for which notification is given a minimum of 6 months prior to
implementation:

 

 

•

Change of manufacturing site

 

•

Change of critical Subcontractor

 

o

Discontinuation of Products

 

 

5.

At Purchaser’s request, samples from 3 separate lots will be provided for the
following changes listed below:

 

 

•

Change to storage conditions

 

•

Change of critical raw material

 

•

Change of analytical specification – outside of current limits

 

•

Change of manufacturing site

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[****] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

13 of 13