DISTRIBUTION AGREEMENT dated as of January 4, 2010 between Insulet Corporation and Ypsomed Distribution AG
Exhibit
10.1
dated
as of January 4, 2010
between
Insulet
Corporation
and
Ypsomed
Distribution AG
Table
of Contents
Page
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ARTICLE
I Appointment of Distributor
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1
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Section
1.1
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Appointment
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1
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Section
1.2
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Exclusivity
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2
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Section
1.3
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Limitations
on Appointment
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2
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Section
1.4
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No
Compensation
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2
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Section
1.5
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Relationship
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2
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ARTICLE
II Marketing and Promotion
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3
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Section
2.1
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Steering
Committee
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3
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Section
2.2
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Promotion,
Advertising and Marketing
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3
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Section
2.3
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Sub-Distributors
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4
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Section
2.4
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Customer
Information
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4
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Section
2.5
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Rights
and Obligations of Distributor
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4
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Section
2.6
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Competing
Products
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6
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ARTICLE
III Distribution of Products
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6
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Section
3.1
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Distributor
Covenants
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6
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Section
3.2
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Branding
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7
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Section
3.3
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Insurance
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7
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ARTICLE
IV Purchase, Sale and Delivery of Products
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7
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Section
4.1
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Supply
of Products
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7
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Section
4.2
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[***]
Minimums
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7
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Section
4.3
|
Forecasts
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8
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Section
4.4
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Transfer
Pricing
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8
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Section
4.5
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Orders
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8
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Section
4.6
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Order
of Precedence
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8
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Section
4.7
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Taxes
and Governmental Charges
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8
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Section
4.8
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Shipment,
Delivery and Title
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8
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Section
4.9
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Rejection
of Delivery
|
9
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Section
4.10
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Terms
of Payment
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9
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Section
4.11
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Late
Charges
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9
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Section
4.12
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Audits
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9
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Section
4.13
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Trade
Price
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9
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ARTICLE
V Compliance with Laws; Regulatory Matters; Recycling
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10
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Section
5.1
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Export
and Trade Regulations
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10
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Section
5.2
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Customer
Complaints and Product Safety
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10
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Section
5.3
|
Recalls
|
10
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Section
5.4
|
Regulatory
Interface
|
10
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Section
5.5
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Failure
to Maintain
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11
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Section
5.6
|
Regulatory
Requirements
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11
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Section
5.7
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Labeling
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11
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Section
5.8
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Local
Laws
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11
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Section
5.9
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Recycling
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11
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ARTICLE
VI Intellectual Property Rights
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11
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Section
6.1
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Grant
of License; Ownership of Intellectual Property Rights
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11
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Section
6.2
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Use
of Intellectual Property Rights
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12
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Section
6.3
|
Assistance
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12
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Section
6.4
|
Notice
of Claims of Infringement
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12
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Section
6.5
|
Notice
of Infringement
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12
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Section
6.6
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Reservation
of Rights
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12
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ARTICLE
VII Confidentiality
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13
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Section
7.1
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Non-Disclosure
Obligations
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13
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Section
7.2
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Ownership
of Material
|
13
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Section
7.3
|
Exceptions
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13
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ARTICLE
VIII Representations, Warranties and Liabilities
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13
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Section
8.1
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By
Insulet
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13
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Section
8.2
|
By
Distributor
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14
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Section
8.3
|
Product
Warranty and Remedies
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14
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Section
8.4
|
No
Implied Warranties
|
14
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Section
8.5
|
Limitation
of Liability
|
15
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ARTICLE
IX Indemnification
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15
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Section
9.1
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Insulet
Indemnity
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15
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Section
9.2
|
Indemnification
Procedure
|
16
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ARTICLE
X Term and Termination
|
17
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Section
10.1
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Term
and Renewal
|
17
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Section
10.2
|
Termination
for Cause
|
17
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Section
10.3
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Termination
for [***]
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17
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Section
10.4
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Termination
for Patent Challenge
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18
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Section
10.5
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Termination
or Expiration Fee
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18
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ARTICLE
XI Rights and Obligations upon Termination
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18
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Section
11.1
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Cessation
of Rights
|
18
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Section
11.2
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No
Penalties; Survival
|
18
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Section
11.3
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Return
of Products and Information
|
19
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Section
11.4
|
Obligations
of Distributor upon Termination
|
19
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ARTICLE
XII General Provisions
|
19
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Section
12.1
|
Notices
|
19
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Section
12.2
|
Definitions
|
20
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Section
12.3
|
Descriptive
Headings; Certain Interpretations
|
22
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Section
12.4
|
Waivers
|
22
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Section
12.5
|
Entire
Agreement and Amendments
|
22
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Section
12.6
|
Severability
|
22
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Section
12.7
|
Assignments
|
23
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Section
12.8
|
Force
Majeure
|
23
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Section
12.9
|
No
Third-Party Beneficiaries
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23
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Section
12.10
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Counterparts
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23
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Section
12.11
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Further
Assurance
|
24
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Section
12.12
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Governing
Law
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24
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Section
12.13
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Governing
Language
|
24
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Section
12.14
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Arbitration
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24
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Section
12.15
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Press
Releases
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25
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EXHIBITS:
Exhibit
I:
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Products
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Exhibit
II:
|
Territory
|
Exhibit
III:
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[***]
Minimums and Pricing
|
Exhibit
IV:
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[***]
|
Exhibit
V:
|
Business
Plans
|
Distribution
Agreement (this “Agreement”), dated as of
January 4, 2010 (the “Effective Date”), between
Insulet Corporation, a Delaware corporation (“Insulet”) and Ypsomed
Distribution AG, Xxxxxxxxxxxxxxxx 0, XX-0000 Xxxxxxxx, Xxxxxxxxxxx (“Distributor”). Each of
Insulet and Distributor are referred to herein as a “Party” or the “Parties.”
Introduction
Insulet
has rights to market, distribute and sell certain products set forth in Exhibit
I (as updated by Insulet from time to time in writing) (the “Products”). Insulet wishes to
distribute the Products by appointment of distributors to make sales in certain
territories.
Insulet
wishes to appoint Distributor as its exclusive distributor to promote,
advertise, market, distribute and sell the Products in the territory referred to
in Exhibit II (the “Territory”) and Distributor
wishes to act as distributor on the terms and conditions set forth in this
Agreement.
Capitalized
terms shall have the meanings ascribed to such terms in Section 12.2 or as
otherwise provided in this Agreement.
For good
and valuable consideration, and in reliance upon the covenants, promises, and
representations and warranties contained herein, the Parties, intending legally
to be bound, hereby agree as follows:
ARTICLE
I
Appointment
of Distributor
Section
1.1 Appointment.
(a) Subject
to the terms and conditions of this Agreement, Insulet hereby appoints
Distributor to act as its exclusive distributor to promote, advertise, market,
distribute and sell the Products in the Territory during the
Term. Distributor hereby accepts the appointment and agrees to use
commercially reasonable efforts to promote, advertise, market, distribute and
sell the Products in the Territory during the Term in accordance with the terms
and conditions of this Agreement.
(b) Subject
to Exhibit II, Sections III and IV, Insulet hereby retains all rights outside
the Territory with respect to the Products in all respects, including the right
to appoint other distributors.
(c) Insulet
shall forward to Distributor all inquiries, requests for information and
purchase orders from Persons in the Territory relating to the
Products.
Section
1.2 Exclusivity.
The appointment in Section 1.1(a) shall be exclusive to Distributor in the
Territory during the Term until the [***]. Subject to Section 4.2, during the
Term until the [***], Insulet shall not (directly or indirectly) appoint as its
distributor any Person to, nor shall itself, promote, advertise, market,
distribute or sell the Products, or any versions thereof, or any competitive
products in the Territory, nor shall supply any Third Party for promotion,
advertisement, marketing, distribution or sale of the Products, or any versions
thereof, or any competitive products, in the Territory.
Section
1.3 Limitations on
Appointment.
Distributor shall not, and, if permitted under applicable Laws, shall cause each
of its Sub-Distributors not to, (i) actively promote, advertise, market,
distribute or sell the Products outside the Territory; or (ii) support by its
own actions any Third Party in doing any of the foregoing (which support
includes, for example and without limitation, providing any written marketing
materials, conducting or financing any clinical trials or otherwise providing
any consideration in support of same). In addition, once Distributor learns of
any conduct by a Sub-Distributor of these prohibited activities, Distributor
shall, if permitted under applicable Laws, use commercially reasonable efforts
to end all such prohibited activities by such Sub-Distributor within a
commercially reasonable time period, which in all events shall be within 6
months of first learning of any such prohibited activities by such
Sub-Distributor, and if unable to end all such prohibited activities by such
efforts: if permitted under applicable Laws, (a) terminate the appointment of
such Sub-Distributor; and (b) stop selling (directly or indirectly through other
Sub-Distributors or otherwise) the Products to such Sub-Distributor. If Insulet
notifies Distributor in writing of any conduct by a non-Affiliated
Sub-Distributor of any such prohibited activities, Distributor shall thereafter
confirm in writing to Insulet that Distributor has complied with the immediately
preceding sentence with respect to such Sub-Distributor. The Parties agree that
if Distributor breaches its obligations under this Section 1.3, Insulet shall
have the right, in Insulet’s sole discretion, to [***].
Section
1.4 No
Compensation. Insulet
is not obligated to pay compensation for Distributor’s performance of its
obligations hereunder, and Distributor’s sole compensation shall arise from its
resale of the Products. Insulet shall not provide Distributor with any other
compensation or benefits, and Insulet shall not be responsible for reimbursement
of any out-of-pocket expenses, except as expressly set forth
herein.
Section
1.5 Relationship. In the
exercise of their respective rights and the performance of their respective
obligations hereunder, the Parties are and shall remain independent contractors.
Nothing in this Agreement shall be construed:
(a) to
give either Party the right or power to direct or control the daily activities
of the other Party;
(b) to
create the relationship between the Parties of principal and agent, franchiser
and franchisee, partners, joint ventures, co-owners or otherwise as participants
in a joint undertaking;
2
(c) to
authorize either Party to bind the other Party to, or assume or create any
contract and obligation of any kind, express or implied, on behalf of the other
Party or to any other Person; or
(d) to
waive any right, interest and claim that one of the Parties may have against any
other Person.
ARTICLE
II
Marketing
and Promotion
Section
2.1 Steering
Committee.
(a) The
Parties shall appoint a committee (the “Steering Committee”)
comprised of one member designated by Insulet and one member designated by
Distributor. The initial members of the Steering Committee shall be the Vice
President International Operations, for Insulet and the Senior Vice President
Marketing and Sales, for Distributor. Each Party may replace its Steering
Committee member at any time upon written notice to the other
Party.
(b) The
Steering Committee shall meet at least on a [***], which meeting can be a
teleconference, and shall be responsible for reviewing and steering the
promotion, advertising and marketing activities relating to the Products and the
performance of the Agreement by the Parties.
(c) Each
Party may invite, with the approval of the other Party (which shall not be
unreasonably withheld), additional individuals to attend one or more meetings of
the Steering Committee as ad hoc guests.
Section
2.2 Promotion, Advertising and
Marketing.
(a) During
the Term, Distributor shall actively promote, advertise, market, distribute and
sell the Products only in the Territory.
(b) Distributor
shall commercialize the Products in accordance with the Business Plans attached
as Exhibit V and such additional Business Plans to be developed by Distributor
during the Term of this Agreement. Distributor shall update the
Business Plans at least annually and present them to Insulet for review no later
than October 1 of each year preceding the implementation of such plan.
Such Business Plan shall include, at a minimum: (i) Distributor’s proposed
promotion, advertising and marketing efforts; and (ii) a list of planned
promotional activities, such as training sessions for the education and training
of Customers.
(c)
Distributor shall produce promotion, advertising and marketing materials for the
Products in the Territory. In connection therewith, Distributor shall conduct
such activities, including development, translation, printing and communication
of marketing, sales, medical education or other related materials (e.g., sales
literature, advertising materials and promotional programs) as commercially
necessary for the distribution and sale of the Products in the Territory (along
with all other documents and other materials intended for public distribution
created by or on behalf of Distributor or any Sub-Distributor regarding Insulet
or any Products, collectively, “Distributor Materials”).
Insulet shall provide such support (e.g., regarding technical information
relating to the Products or printed materials such as product labels) as is
reasonably necessary to permit Distributor to fulfill any relevant regulatory
requirements with regard to the Distributor Materials. Distributor shall [***],
and shall provide all Distributor Materials that would entail public
communication regarding the Products to Insulet (translated in English, if
applicable) for its prior review and prompt approval insofar as the material
relates to the Products, which approval shall not be unreasonably withheld,
provided that any
accurate translation of any such materials previously approved by Insulet, or
any materials provided by Insulet, shall not require Insulet’s separate
approval. Unless Insulet has notified Distributor of any objections within
[***], Insulet shall be deemed to have approved the Distributor
Materials.
3
(d) To
facilitate Distributor’s performance of its obligations under this Section 2.2,
Insulet shall, [***] make available to Distributor the following materials
written in English: (i) commercial, informational and educational materials or
publications created by or on behalf of Insulet relating to the Products; and
(ii) samples of artwork created by or on behalf of Insulet, in each case which
Insulet may have in its possession or control, sufficient to allow Distributor
to translate (where necessary) and print, at Distributor’s expense, sales
literature, advertising materials, promotional programs or other materials
required to promote, advertise, market, sell and distribute the
Products.
Section
2.3 Sub-Distributors.
Distributor shall be entitled to appoint one or more Sub-Distributors to
promote, advertise, market, distribute or sell the Products in the Territory in
accordance with the terms and conditions of this Agreement; provided, however, that
Distributor shall not utilize or engage any Competitor of Insulet as a
Sub-Distributor, without the prior written consent of Insulet. Distributor shall
remain jointly and severally liable under this Agreement for the actions and
omissions of each of its Sub-Distributors, and Distributor shall be solely
responsible for any commitments, obligations or liabilities made by any of its
Sub-Distributors.
Section
2.4 Customer
Information.
(a) Within
[***] during the Term, Distributor shall provide Insulet with a [***] report,
which shall include the following information: (i) the number of new Customers
added in the [***] by country; (ii) the number of unit sales of each Product by
country; (iii) the average price paid by each Customer for each Product by
country; (iv) any information required by Law, such as Customer complaint
information; and (v) any such other information that may be reasonably requested
by Insulet. Notwithstanding anything to the contrary in this Agreement,
[***].
Section
2.5 Rights and Obligations of
Distributor.
Consistent with applicable Laws, Distributor shall actively promote the sale and
distribution of the Products in the Territory. In particular, Distributor
shall:
(a) appoint
and train appropriately qualified staff to carry out its duties under this
Agreement;
(b) undertake
debtor collection;
4
(c) check
product availability and confirm delivery dates to Customers;
(d) take
orders from Customers and place such orders with Insulet;
(e) track
Customers’ orders and respond to Customers’ inquiries on orders;
(f) undertake
key account management;
(g) provide
other customer service activities as requested by Insulet and agreed to by
Distributor;
(h) assume
no obligation or liability in Insulet’s name;
(i) refrain
from acting in such a manner as to be construed an employee or agent of
Insulet;
(j) make
no representations or claims with respect to the Products, except in accordance
with Section 3.1;
(k) maintain
sufficient inventory to fulfill its obligations under this Agreement and to
Customers;
(l) keep
Insulet informed on a reasonably regular basis on sales activity, and promptly
disclose to Insulet all material information relating to the Products obtained
concerning purchasing plans of existing and prospective Customers, provided, that
[***];
(m) within
30 days of expiration or termination of this Agreement, return to Insulet, at
Insulet’s expense, all samples, catalogs, literature, correspondence, sales
records, market data or information and other similar documents or materials on
hand relating to the Products; and
(n) submit
marketing materials relating to the Products, if any, to local Governmental
Authorities only in those countries in the Territory where such submissions are
required or necessary, or as directed by Insulet or any Governmental Authority
in the Territory, and provide reasonable assistance to Insulet in connection
with Insulet’s submission of marketing materials relating to the Products in any
country or jurisdiction in which Insulet is required by Laws to make such
submissions.
Distributor
may agree to provide other incidental services and perform other administrative
functions in connection with or incidental to its duties hereunder, consistent
with applicable Laws.
5
Section
2.6 Competing
Products. [***]
Distributor shall not, and, if permitted under applicable Laws, shall cause its
Sub-Distributors not to, directly or indirectly engage in the [***], other than
the Products as provided in this Agreement. In addition, once Distributor learns
of any conduct by a Sub-Distributor of such activities, Distributor shall,
unless such activities have been approved by Insulet and unless prohibited by
applicable Laws, use commercially reasonable efforts to promptly end all such
activities by such Sub-Distributor within a commercially reasonable time period,
[***] and if unable to end all such prohibited activities by such efforts: if
permitted under applicable Laws (a) terminate the appointment of such
Sub-Distributor; and (b) stop selling (directly or indirectly through other
Sub-Distributors or otherwise) the Products to such Sub-Distributor. If Insulet
notifies Distributor in writing of any conduct by a non-Affiliated
Sub-Distributor of any such prohibited activities, Distributor shall thereafter
confirm in writing to Insulet that Distributor has complied with the immediately
preceding sentence with respect to such Sub-Distributor. The Parties agree that
if Distributor breaches its obligations under this Section 2.6, Insulet shall
have the right, in Insulet’s sole discretion, to [***]
ARTICLE
III
Distribution
of Products
Section
3.1 Distributor
Covenants. Distributor
hereby covenants and agrees for the benefit of Insulet that Distributor
shall:
(a) conduct
any promotion, advertising, marketing, distribution or sale of the Products in
accordance with all applicable Laws and in material conformance with applicable
industry codes, guidelines and standards, including each as amended and in force
from time to time, and shall cultivate good relationships with Customers and
potential customers in the Territory in accordance with sound commercial
principles;
(b) observe
and comply with such storage, stock control and operational practices and
procedures with respect to the Products as may be legally required and as
Insulet may specify or approve from time to time;
(c) not
make any representation to Customers nor give any warranties other than those
printed on the Products’ packaging or labeling or included within marketing or
sales aid material or other Product information provided or agreed to by
Insulet;
(d) during
the Term of this Agreement and for 3 years following expiration or termination
of this Agreement, or such longer period as may be required by applicable Laws,
maintain complete and accurate books of account and records showing orders
placed, sales and services stock with respect to the Products;
(e) promote
the Products solely for the indications and other conditions of use approved by
the United States Food and Drug Administration (“FDA”) (or other Governmental
Authority) as described in the Products’ package inserts or FDA-approved
labeling;
(f) not
use the services of any Person debarred or suspended under section 306 of the
Federal Food, Drug, and Cosmetic Act, as amended, in performing its obligations
or exercising its rights under this Agreement. Distributor shall promptly notify
Insulet if any Person whose services Distributor is using in the performance of
its obligations or exercise of its rights under this Agreement becomes debarred
or suspended;
6
(g) submit
marketing materials relating to the Products, if any, to local Governmental
Authorities only in those countries in the Territory where such submissions are
required or necessary or as directed by Insulet or any Governmental
Authority;
(h) be
responsible for all reimbursement activity relating to the
Products;
(i) promote,
advertise, market, distribute and sell the Products in the Territory in
substantially the same manner as other of Distributor’s businesses;
and
(j) execute
trade terms, quantity discount, settlement terms, etc. in substantially the same
manner as other of Distributor’s businesses.
Section
3.2 Branding.
Distributor shall have the right to choose the trademarks, logos and/or trade
dress (the “Product
Branding”) pursuant to which the Products are marketed and sold in the
Territory, provided,
however, that Insulet’s “OMNIPOD” trademark shall be included in the
Product Branding in a manner to be mutually agreed upon by the Steering
Committee.
Section
3.3 Insurance. The
Parties shall maintain adequate insurance, in such amounts and with such
insurance companies as is customary in accordance with sound business practices
consistent with the nature of the Products. Each Party shall upon the
request of the other Party furnish certificates of such insurance.
ARTICLE
IV
Purchase,
Sale and Delivery of Products
Section
4.1 Supply of
Products.
(a) Insulet
shall use commercially reasonable efforts to manufacture and supply the Products
with the Product Branding for Distributor during the Term with such quantities
of the Products as Distributor shall order from Insulet on the terms and
conditions set forth in this Agreement.
(b) Insulet
shall have the right to satisfy its supply obligations under this Agreement
either in whole or in part through arrangements with Affiliates or Third Parties
engaged by Insulet, provided that Insulet remains
solely liable for the performance of such obligations.
(c) Insulet
shall notify Distributor as soon as commercially reasonable, taking due account
of Distributor’s need to be informed, in the event Insulet anticipates any
problems with supplying the quantities of the Products set forth in any forecast
provided pursuant to Section 4.3, and the Parties shall agree on appropriate
measures to address any such problems, including [***].
Section
4.2 [***]
Minimums. The
Parties agree to establish [***] Minimums for the Products in accordance with
the following process:
7
(a) Exhibit
III sets forth [***] Minimums [***]. [*** ] Minimums
[***]
(b) [***]
(c) If
a [***], Insulet shall give written notice thereof to Distributor, stating in
reasonable detail the basis for [***]
Section
4.3 Forecasts. Upon
execution of this Agreement, and for [***], Distributor shall provide to
Insulet, [***] a written forecast of its best estimate Order forecast for the
[***] such forecast to be broken down Product-by-Product, month-by-month and
country-by-country. [***].
Section
4.4 Transfer
Pricing.
The transfer prices to be paid by Distributor for purchases of Products from
Insulet for [***] shall be fixed as set forth in Exhibit III.
Section
4.5 Orders.
(a) All
orders from Distributor to Insulet shall be initiated by a written purchase
order specifying the quantities of the Products and requested dates of shipment
(each, an “Order”) and
shall be deemed accepted within [***] after receipt by Insulet, unless Insulet
notifies Distributor in writing within [***].
(b) Insulet
shall not refuse to accept an Order which falls [***]. Insulet shall be entitled
to reject or reschedule any Order that [***], provided, that Insulet shall
not refuse to accept an Order which [***] Minimums.
(c) Contemporaneous
with the execution of this Agreement, Distributor shall issue to Insulet [***]
Minimums [***]
Section
4.6 Order of
Precedence. Any
inconsistency in any documents relating to the purchase of the Products shall be
resolved by giving precedence in the following order: (i) the terms and
conditions of this Agreement (including the Exhibits attached hereto); (ii) the
provisions and text appearing on the face of the applicable Order insofar as
they refer to the specific Order; and (iii) other documents, exhibits and
attachments which accompany such Order.
Section
4.7 Taxes and Governmental
Charges. Prices
do not include any taxes or other governmental charges, including import or
export duties, value-added, sales, use or privileges taxes, property or excise,
or similar taxes levied by any government. Distributor shall pay all such taxes
or charges on or before the due date.
Section
4.8 Shipment, Delivery and
Title. Insulet
shall deliver the Products EXW (Incoterms 2000) at a facility designated by
Insulet in [***]on the date as specified in the Order, provided, that such dates
specified in the Orders shall allow for a delivery time of at least [***]. Title
to each of the Products shall pass to Distributor (or to the Customer, where
Insulet ships direct to a Customer) when delivery is made to the carrier at such
point of shipment. Insulet shall be entitled to change the point of shipment,
provided, however, that
[***].
8
Section
4.9 Rejection of
Delivery.
(a) Within
[***], Distributor shall notify Insulet in writing of any physical damage or
issue which is apparent from an external review of the packaged Products, and
within [***], Distributor shall notify Insulet in writing of such claims by the
Customer. In each case, Distributor shall, if possible, include with its
notice sufficient samples to permit Insulet to evaluate Distributor’s or the
Customer’s claims.
(b) Within
[***], Insulet will inform Distributor in writing whether it accepts or rejects
Distributor’s or the Customer’s claims. If the claim is accepted, then Insulet
shall [***] Distributor shall return all non-conforming Products (less
reasonable samples) in its possession at Insulet’s expense within [***], provided that such shipment
can be made in accordance with applicable Laws, including export
Laws.
(c) If
Insulet does not accept the claim, the Parties shall submit samples of the
non-conforming Products for testing to an independent expert agreed upon by both
Parties acting reasonably. If the Parties are unable to agree on the
identity of the expert, the Parties shall jointly apply to a mutually agreed
Third Party for the appointment of an expert. The expert’s determination
will be final absent of manifest error. The costs associated with such
expert determination shall be [***].
Section
4.10 Terms of
Payment.
Insulet shall issue invoices for each shipment upon delivery in accordance with
Section 4.8. Terms of payment shall be net [***] from date of the
invoice. All payments shall be in United States Dollars and shall be fully
net, without set-off, deduction or counterclaim.
Section
4.11 Late
Charges. If
Distributor fails to pay the price or any other payment due to Insulet promptly
and when due, Insulet may recover, in addition to the price or payment, interest
thereon at a rate of [***].
Section
4.12 Audits.
All records relating to regulatory issues in connection with the Products will
be available for audit by Insulet and Governmental Authorities biannually
at all reasonable times and upon reasonable notice, and for a period of three
(3) years following the expiration or termination of this Agreement; provided, however, that any
such inspection by Insulet or its designees shall be conducted in a manner that
does not unreasonably interfere with the operation of the day-to-day business
affairs of the Party being inspected. Insulet shall pay all costs and
expenses with respect to any such inspection or audit. [***]
Section
4.13 Trade
Price.
Distributor shall be free to set its own trade prices. Distributor shall
keep Insulet informed as to the trade prices so
determined.
9
ARTICLE
V
Compliance
with Laws; Regulatory Matters; Recycling
Section
5.1 Export and Trade
Regulations.
Both Parties shall endeavor to at all times carry out the transactions
contemplated by this Agreement in conformity with all applicable Laws (including
the United States Export Administration Acts), and shall obtain all necessary
permits and licenses required in connection with the purchase, installation,
sale, shipment, service or use of the Products. Shipments by Insulet are
or may be subject to restrictions and limitations imposed by United States
export controls and other trade sanctions. Each Party shall at all times
use commercially reasonable efforts to keep the other Party informed of, and
both Parties shall at all times use commercially reasonable efforts to comply
with, such sanctions, controls and regulations, as well as the United States
Foreign Corrupt Practices Act, in its respective use and disposition of the
Products. If Insulet learns, or has reasonable cause to believe, or if any
branch or agency of the government of the United States claims that a violation
of any applicable export regulation or other trade sanction, export control or
trade regulation by Distributor has occurred or is likely to occur because of
any shipment by Insulet to Distributor, Insulet shall promptly notify
Distributor and may, in addition to any other remedy it may have, suspend all
shipments to Distributor until Insulet is satisfied that such violation did not
occur or has ceased to occur, or such claim is withdrawn or otherwise resolved
in favor of Insulet.
Section
5.2 Customer Complaints and
Product Safety.
The Parties will cooperate in and each Party is responsible for full compliance
with its requirements regarding Vigilance, Product complaint, Field Safety
Notices, Product Recall requirements set forth in MEDDEV 2.12-1 rev. 5 and/
any future revisions as well as corresponding regulatory requirements in all
countries of the Territory listed in Section II of Exhibit II and internal
corporate procedures and policies. Distributor shall promptly notify Insulet of
any customer complaints of which it may become aware in relation to the Products
or any component thereof. Distributor will provide such Products to
Insulet for evaluation. Insulet will perform evaluations of such customer
complaints and supply the results of such evaluations to Distributor, including,
but not limited to, corrective action(s) and investigations. Distributor
will respond directly to the Customer regarding the results of these
evaluations. Insulet will be responsible for creating and implementing any
corrective or preventive action that concerns the Products [***] Insulet
is responsible to file all necessary filings with Governmental
Authorities.
Section
5.3 Recalls. In
the event any component of the Products is subject to a recall in the Territory,
the Parties will cooperate, under overall Insulet oversight, to manage the
process in a commercially reasonable manner. In the event of a recall or
potential recall of any component of the Products, Insulet will notify and
consult with Distributor with regard to the measures to be taken consistent with
good business practices. Insulet shall be responsible for implementing any
recall that concerns the Products, and [***]
Section
5.4 Regulatory
Interface. Insulet shall exercise
commercially reasonable efforts to obtain and Maintain any Product Registrations
in the countries of the Territory as set forth in Section II of Exhibit II
during the Term. As used in this Section 5.4, the term “Maintain” means that:
(a) Insulet shall exercise commercially reasonable efforts to maintain the
Product Registrations as valid and in force with the appropriate Governmental
Authorities, (b) Insulet shall use commercially reasonable efforts to the
extent possible to minimize the number and extent of any changes to the Product
Registrations, and (c) Insulet shall notify Distributor of any change to
any of the Product Registrations during the Term and any such change requested
or required by appropriate Governmental Authorities in the Territory. As
between the Parties hereto, it is agreed that the Product Registrations shall be
held in the name of Insulet, who shall be the beneficial owner of all Product
Registrations and Distributor may not use the Product Registrations, or any of
them, on or in respect of any product other than the Products or use any
authorization other than one or more of the Product Registrations on or in
respect of the Products, except as may be approved in writing by Insulet.
Distributor agrees to use its commercially reasonable efforts to assist Insulet,
[***] in obtaining and Maintaining the Product Registrations. [***]
If any Governmental Authority gives notice to Insulet that its Product
Registration may be invalid or may be revoked, limited, or conditioned, Insulet
shall promptly inform Distributor, but in any case
[***]
10
Section
5.5 Failure to
Maintain. At
any time during the Term, if Insulet fails to Maintain an existing Product
Registration or any of the Product Registrations becomes invalid or not in full
force and effect with the appropriate authorities in any country in the
Territory, then [***], provided that
[***].
Section
5.6 Regulatory
Requirements. Distributor shall at
all times promote, advertise, market distribute and sell the Products in
accordance with all applicable Laws. Distributor shall also follow (a) all
relevant current written regulatory, quality assurance instructions and
guidelines agreed by the Parties.
Section
5.7 Labeling. Subject to Section 3.2
hereof, all labeling and package inserts used in any way in connection with the
Products shall comply with the Product labeling supplied or approved in writing
by Insulet and with all applicable Laws. Distributor shall promptly inform
Insulet of any local requirements affecting the labeling and package inserts of
the Products; provided,
however, that Insulet
remains independently obligated to be aware of regulatory requirements in all
jurisdictions where it has obtained and Maintains a Product
Registration.
Section
5.8 Local
Laws. Distributor shall keep
Insulet informed of any Laws of the Territory which might be applicable to, or
affect the use or sale of, the Products in the Territory. Distributor
shall inform Insulet of any instructions or requests inconsistent with these
Laws, provided, however, that Insulet remains
independently obligated to be aware of regulatory requirements in all
jurisdictions where it has obtained and Maintains a Product
Registration.
Section
5.9 Recycling.
The Parties shall collaborate and agree upon an acceptable recycling program for
the Products. The costs associated with such program shall be
[***]
ARTICLE
VI
Intellectual
Property Rights
Section
6.1 Grant of License; Ownership
of Intellectual Property Rights.
Insulet hereby grants Distributor a non-exclusive, royalty-free, limited license
during the Term and under the Intellectual Property Rights of Insulet relating
to the Products solely to purchase Products from Insulet and to promote,
advertise, market, distribute and sell Products to Customers in the Territory in
accordance with the terms and conditions of this Agreement. Distributor
hereby grants Insulet a non-exclusive, royalty-free, limited license during the
Term and under the Intellectual Property Rights of Distributor to use the
Product Branding solely for labeling of the Products pursuant to this Agreement
and for no other purpose whatsoever.
11
Section
6.2 Use of Intellectual Property
Rights.
Distributor shall not alter, deface, remove, cover, mutilate, or add to, in any
manner whatsoever, any patent notice, copyright notice, trademark, trade name,
serial number, model number or legend that Insulet may attach or affix to the
Products. Distributor also agrees that during the Term, it will not
otherwise register or use any of Insulet’s Intellectual Property Rights or any
word, symbol or design confusingly similar thereto, unless agreed by
Insulet.
Section
6.3 Assistance. Distributor
shall, at the expense of Insulet, take such steps as Insulet may reasonably
require to assist Insulet in maintaining the validity and enforceability of the
Intellectual Property Rights of Insulet, and Distributor will not do, or allow
or authorize any Person to do, any act which could invalidate or be inconsistent
with the Intellectual Property Rights of Insulet and shall not omit, or allow or
authorize any Person to omit, to do any act which, by its omission, could
invalidate or be inconsistent with the Intellectual Property
Rights.
Section
6.4 Notice of Claims of
Infringement.
Distributor shall promptly notify Insulet of (a) any claims or objections that
its use of the Intellectual Property Rights in connection with the promotion,
advertising, marketing, distribution or sale of the Products may or will
infringe the copyrights, patents, trademarks or other proprietary rights of
another Person, and (b) any and all infringements, imitations, illegal use, or
misuse, by any Person, of the Intellectual Property Rights of Insulet which come
to its attention; provided, however, that Distributor
will not take any legal action relating to the protection of any Intellectual
Property Rights of Insulet without the prior written approval of Insulet; and
provided further, that Distributor
shall render Insulet, [***], all reasonable assistance in connection with any
matter pertaining to the protection of the Intellectual Property Rights, whether
in courts, administrative agencies, or otherwise.
Section
6.5 Notice of
Infringement.
Distributor shall promptly notify Insulet of any infringement, violation, claim
or objection in the Territory of or relating to the Intellectual Property
Rights, Confidential Information or Product Registrations (including trademarks,
patents, know-how, government licenses and health registrations) of Insulet
which come to Distributor’s attention, and shall, [***], cooperate in taking
such action as Insulet may reasonably deem necessary in connection with any such
infringement, violation, claim or objection.
Section
6.6 Reservation of
Rights.
Except as otherwise expressly set forth herein, either Party reserves all right,
title and interest in the Intellectual Property Rights of it or any of its
Affiliates, and the other Party shall not acquire, or be deemed to have
acquired, any right, title or interest whatsoever as a result of this Agreement
in the Intellectual Property Rights of either Party or any of its
Affiliates. Subject to Section 11.3, upon expiration or termination of
this Agreement for any reason, the Parties agree to immediately discontinue any
further use of the Intellectual Property Rights of the other Party granted under
this Agreement.
12
ARTICLE
VII
Confidentiality
Section
7.1 Non-Disclosure
Obligations.
During the Term, a Party may, at its sole discretion, disclose certain
Confidential Information to the other Party. This information will be used
solely to permit the receiving Party to exercise its rights and perform its
obligations under this Agreement. The receiving Party shall not disclose
any Confidential Information to a Third Party and shall refrain from using or
exploiting any and all Confidential Information for any purpose or activities
other than those specifically authorized in this Agreement. The receiving
Party shall keep such Confidential Information secret during the Term of this
Agreement and for [***] after the expiration or termination hereof.
Section
7.2 Ownership of
Material. Except as otherwise
expressly provided for herein, all files, lists, records, documents, drawings
and specifications which incorporate or refer to all or a portion of the
Confidential Information shall remain the sole property of the disclosing
Party. Such materials shall be promptly returned upon the earlier of (a)
the disclosing Party’s reasonable request, or (b) expiration or termination of
this Agreement.
Section
7.3 Exceptions. The provisions of this
Article VII shall not apply, or shall cease to apply, to data and information
supplied by a Party if such data or information (a) was already known to the
receiving Party, (b) becomes part of the public domain without a breach of
confidence by the receiving Party or any other Person, (c) was received by the
receiving Party from a Third Party without restrictions on such Third Party’s
use in favor of the disclosing Party, or (d) was required to be disclosed
pursuant to any statutory or regulatory provision or court order (in which case
only such portion of Confidential Information shall be disclosed as is required,
and the provisions of this Article VII shall not apply for disclosure in
accordance with the respective statutory or regulatory provision or court order
only), provided that
the receiving Party shall have the burden of establishing any of the foregoing
exceptions.
ARTICLE
VIII
Representations,
Warranties and Liabilities
Section
8.1 By
Insulet.
Insulet represents and warrants to Distributor that (i) Insulet has the full
right and authority to enter into this Agreement and grant the rights granted
herein; (ii) Insulet has not previously granted and will not grant any right in
conflict with any of the rights granted herein; and (iii) to Insulet’s knowledge
on the Effective Date, there is no existing or threatened action, suit or claim
pending against it with respect to its right to enter into and perform any of
its obligations under this Agreement.
(a) Insulet
represents and warrants to Distributor that all applicable Laws and the
scientific and technical state of the art are observed and
fulfilled.
(b) Insulet
represents and warrants to Distributor that no Products delivered are encumbered
in any form by Third Party rights (pledge, ownership, co-ownership, joint
ownership and the like).
13
(c) Insulet
represents and warrants to Distributor that the Products, the manufacture of
Products and all documentation related to the manufacture and the Products will
conform to any regulatory requirements in the countries of the Territory listed
in Section II of Exhibit II.
(d) Insulet
represents and warrants to Distributor that to the best of Insulet’s knowledge
no intellectual property rights of Third Parties bar the use of the Products in
the Territory as contemplated by this Agreement.
Section
8.2 By
Distributor.
Distributor represents and warrants to Insulet that (i) Distributor has the full
right and authority to enter into this Agreement and grant the rights granted
herein; (ii) Distributor has not previously granted and will not grant any right
in conflict with any of the rights granted herein; and (iii) to Distributor’s
knowledge on the Effective Date, there is no existing or threatened action, suit
or claim pending against it with respect to its right to enter into and perform
its obligations under this Agreement.
Section
8.3 Product Warranty and
Remedies.
(a) Subject
to Section 8.3(b), Insulet hereby (i) warrants that [***]; (ii) warrants that
[***]; and (iii) undertakes to use commercially reasonable efforts to deliver
[***].
(b) Distributor
shall maintain inventory of Products on a first in, first out (FIFO)
basis. For Products with expiration date, Distributor shall
distribute such Products by lowest expiration date first.
(c) Subject
to Section 4.9, the obligation of Insulet under the warranties set forth in this
Section 8.3 is limited to [***]. The foregoing notwithstanding, Insulet
shall not be responsible for damage to any Product resulting from misuse,
negligence or accident, or resulting from repairs or alterations made by any
Person not duly authorized by Insulet in writing.
Section
8.4 No Implied
Warranties.
THE EXPRESS REPRESENTATIONS AND WARRANTIES GIVEN IN THIS AGREEMENT ARE THE ONLY
REPRESENTATIONS OR WARRANTIES GIVEN BY INSULET WITH RESPECT TO THE PRODUCTS AND
ARE GIVEN IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING THOSE OF NONINFRINGEMENT, TITLE, MERCHANTABILITY, COURSE OF
DEALING, USAGE OF TRADE, AND FITNESS FOR A PARTICULAR PURPOSE.
DISTRIBUTOR’S EXCLUSIVE REMEDIES AND INSULET’S SOLE LIABILITY FOR ANY
NONCONFORMITY OR DEFECT IN ANY PRODUCT SHALL BE THOSE EXPRESSED IN THIS
AGREEMENT.
14
Section
8.5 Limitation of
Liability. An
essential purpose of the limited exclusive liabilities and remedies in this
Agreement is allocation of risk between Insulet and Distributor, which
allocation of risks is reflected in the purchase price for the Products.
EXCEPT FOR INSULET’S INDEMNIFICATION OBLIGATIONS SET FORTH IN SECTION 9 AND/OR
INSULET’S LIABILITY ARISING OUT OF TERMINATION OF THIS AGREEMENT BY DISTRIBUTOR
PURSUANT TO SECTION 10.2, OR AS A RESULT OF A BREACH OF SECTION 7, UNDER NO
CIRCUMSTANCES SHALL INSULET’S LIABILITY ARISING OUT OF OR IN CONNECTION WITH
THIS AGREEMENT OR INSULET’S PERFORMANCE OR ASSERTED FAILURE TO PERFORM
HEREUNDER, IN CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, EXCEED
[***]. EXCEPT FOR LIABILITY ARISING AS A RESULT OF A PARTY’S
INDEMNIFICATION OBLIGATIONS SET FORTH IN SECTION 9 OR AS A RESULT OF A BREACH OF
SECTIONS 6.1 AND/OR 7, IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR SPECIAL,
INCIDENTAL, PUNITIVE, CONSEQUENTIAL, TORT OR ANALOGOUS DAMAGES, INCLUDING
DAMAGES RESULTING FROM LOSS OF USE, PROFITS, REVENUES, BUSINESS OR GOODWILL,
WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY
THEREOF.
ARTICLE
IX
Indemnification
Section
9.1 Insulet
Indemnity.
(a) Insulet
will indemnify, defend, and hold harmless Distributor, and each of its officers,
directors, agents, employees, representatives, successors, and assigns
(collectively, “Distributor
Indemnitees”), from and against any and all liabilities, losses, damages,
and expenses , including without limitation reasonable attorney’s fees and
expenses (the “Losses”)
relating to any demand, claim, suit or proceeding brought by a Third Party to
the extent arising from or occurring as a result of: (i) Insulet’s material
breach of this Agreement, (ii) any negligent or willful act or omission by or on
behalf of Insulet, (iii) violation of any applicable Law by Insulet, (iv) the
actual or alleged infringement of a claim of a patent or the actual or alleged
infringement or misappropriation of a Third Party Intellectual Property Right by
the Products, (v) physical injury (including death) and/or property damage
actually or allegedly caused by the Products, or (vi) any other representation,
act or omission by or on behalf of Insulet, including Insulet’s performance of
or failure to perform any term or condition of this
Agreement. Insulet shall not be liable for any Losses resulting from
the negligent or willful misconduct of any Distributor Indemnitee.
(b) Distributor
Indemnity. Insulet shall not be liable for any Losses to the
extent incurred by Distributor or any other person or entity, and Distributor
shall indemnify, defend, and hold harmless Insulet and its Affiliates and their
officers, directors, agents, employees, representatives, successors, and assigns
(collectively, “Insulet
Indemnitees”) from and against any and all Losses relating to any demand,
claim, suit or proceeding brought by a Third Party to the extent arising from or
occurring as a result of (i) Distributor’s material breach of this
Agreement, (ii) any negligent or willful act or omission by or on behalf of
Distributor; (iii) violation of any applicable Law by Distributor, (iv) the use
of any Product or part thereof furnished in combination with products, software
or data not supplied by Insulet, (v) any modification made to the Products
without Insulet’s prior written consent, (vi) any termination or expiration of
any Sub-Distributor (to the extent not attributable to any direct relationship,
including any relationship preceding this Agreement, entered into between
Insulet and such Sub-Distributor independently from this Agreement), or (vii)
any other representation, act or omission by or on behalf of Distributor,
including Distributor’s performance of or failure to perform any term or
condition of this Agreement. Distributor shall not be liable for any
Losses resulting from the negligent or willful misconduct of any Insulet
Indemnitee.
15
Section
9.2 Indemnification
Procedure.
(a) A
Party that intends to claim indemnification under this Section 9 shall promptly
notify the indemnifying Party of any such claims in respect of which such Party
intends to claim such indemnification, and if applicable such indemnifying Party
shall assume the defense thereof with counsel mutually satisfactory to the
Parties; provided that
such Party shall have the right to retain its own counsel and, in case
compensation for fees and expenses are not otherwise awarded, compensation for
such reasonable costs shall be paid by such indemnifying Party provided such indemnifying
Party is responsible for the defense thereof, if representation of such Party by
the counsel retained by such indemnifying Party would be inappropriate due to
actual or potential conflicting interests between such Party and any other Party
represented by such counsel. The indemnification provided for by this
Section 9 shall not apply to amounts paid in settlement of any such claim if
such settlement is effected without the consent of the indemnifying Party, which
consent shall not be unreasonably withheld. The failure to deliver notice
to the indemnifying Party within a reasonable time after the commencement of any
such action, if materially prejudicial to its ability to defend such action,
shall relieve the indemnifying Party of any liability to the other Party under
this Section 9.3 to the extent so prejudiced, but the omission so to deliver
notice to such indemnifying Party shall not otherwise relieve it of any
liability that it may have to such other Party. The indemnified Party
shall cooperate fully with the other Party in the investigation of any such
claim covered by this indemnification.
(b) If
Distributor receives a demand, claim, suit or proceeding subject to Insulet
indemnification under Section 9.1(a)(iv), Distributor shall notify Insulet
promptly in writing and give Insulet information, assistance and exclusive
authority to evaluate, defend and settle such claim. Insulet shall then at
its own expense and option, (i) settle the claim (which settlement shall include
for Distributor the right to sell and use the Products pursuant to this
Agreement); (ii) procure for Distributor the right to sell and use the Product
pursuant to this Agreement; (iii) replace or modify the Product to avoid
infringement; (iv) defend against such claim; or (v) remove the Product and
indemnify and hold harmless Distributor. Should any court of competent
jurisdiction hold in a final decision that the sale, manufacture, or use of such
Product constitutes infringement, Insulet shall pay any costs and damages
finally awarded against Distributor on the account of such infringement, and if
the use of such Product is enjoined, Insulet shall take one more of the actions
under clauses (ii), (iii) or (v) above. Insulet reserves the right, at its
sole option, to notify Distributor in writing that as a result of a claim, suit
or proceeding or threat of same in any given country, Distributor may not market
or sell the Products in such country, effective as of such written notice,
subject to full indemnification of Distributor. The foregoing states the
entire and complete liability of Insulet for any patent infringement or claimed
infringement by reason of the sale, manufacture or use of the Products or any
part thereof. This Section 9.3(b) shall also apply in the event Insulet receives
a claim, suit or proceeding relating to an actual or alleged infringement of a
claim of a patent or an actual or alleged infringement or misappropriation of a
Third Party Intellectual Property Right by the
Products.
16
ARTICLE
X
Term
and Termination
Section
10.1 Term and
Renewal.
(a) The
initial term of this Agreement shall be for a period of 5 years [***] unless
earlier terminated under the provisions of this Agreement (the “Term”).
(b) Fifteen
months prior to the end of the Term, the Parties shall negotiate in good faith
to enter into an amendment of this Agreement to include a renewal term for this
Agreement.
Section
10.2 Termination for
Cause. This
Agreement may be terminated by Insulet or Distributor in the event of any of the
following:
(a) immediately
upon written notice to the other, if the other Party becomes insolvent or seeks
protection under any bankruptcy, receivership, trust deed, creditors
arrangement, composition or comparable proceeding, or if any such proceeding is
instituted against the other Party which proceeding remains undismissed for a
period of 30 days; or
(b) in
the event that the other Party fails to perform or otherwise materially breaches
any of its obligations hereunder, and does not cure such failure or breach
within 60 days of receipt of written notice from the non-breaching Party of such
failure or breach. In no event, however, shall such notice of
intention to terminate be deemed to waive any rights to damages or any other
remedy which the Party giving notice of breach may have as a consequence of such
failure or breach.
For
clarity, the date of any notice of termination for cause under this Section 10.2
shall also be [***]
Notwithstanding
the foregoing, Insulet shall have the right, in its sole discretion to in lieu
of terminating the Agreement in full pursuant to Section 10.2, to [***] Minimums
[***] Minimums [***]
If
Insulet terminates this Agreement pursuant to this Section 10.2 due to
Distributor’s breach of Section 2.6 hereof, Insulet shall have, the right to
[***] For clarification [***]
Section
10.3 Termination for
[***].
(a) Insulet
may terminate this Agreement upon [***] written notice if [***], provided, that [***] and
provided further, that
[***].
(b) Insulet
may terminate this Agreement upon [***] written notice if [***].
For
clarity, the date of any notice of termination under this Section 10.3 shall
also be [***]
17
Notwithstanding
the foregoing in this Section 10.3, [***]
Section
10.4 Termination for Patent
Challenge. If
Distributor directly or indirectly initiates any challenges of Insulet’s patent
rights, [***] and [***]
Section
10.5 Termination or Expiration
Fee.
(a) In
the event of any termination of this Agreement by Insulet or Distributor or upon
the expiration of this Agreement, [***]:
[***]
[***]
(b) In
the event of termination of this Agreement by Insulet or Distributor with regard
to a Product in any individual country(ies), [***]
[***]
[***]
The
Parties agree that [***] In the event that [***]
ARTICLE
XI
Rights
and Obligations upon Termination
Section
11.1 Cessation of
Rights. Upon expiration,
non-renewal or termination (collectively, “Termination”) of this
Agreement for any reason whatsoever, no Party and none of its directors,
officers, stockholders or Affiliates shall have any further liability or
obligation to the other Party under this Agreement, except with respect to
Sections 2.5(m), 3.1(d), 4.6, 4.7, 4.9, 4.10, 4.11, 4.12, 5.2, 5.3, 6.2,
6.6, 8.3, 8.4, 8.5, 10.2, 10.4 and 10.5, Articles 7, 9, 11 and 12 and the
definitions in Exhibit I (which shall survive Termination of this Agreement),
except that nothing in this Section 11.1 shall prejudice any rights,
claims, or causes of action that may have accrued hereunder or with respect
hereto prior to the date of such Termination, including for breach of this
Agreement (whether based upon the Termination or otherwise).
Section
11.2 No Penalties;
Survival. Without prejudice
to any rights or right of action which may have accrued during the Term, and
subject to Sections 10.2, 10.4 and 10.5, neither Party shall be entitled to any
compensation or other penalty arising out of Termination, provided this Agreement has
expired or been terminated in accordance with its terms. Any claim, the cause of
which has arisen during the Term of this Agreement, and which is not submitted
and properly substantiated [***] shall be deemed waived and shall be
conclusively barred from assertion by the claimant unless the delay in
submission or substantiation is due to circumstances beyond the claimant’s
control.
18
Section
11.3 Return of Products and
Information. Upon Termination of this
Agreement, Distributor shall promptly and [***] return to Insulet or a Third
Party designated by Insulet, all Products samples, Confidential Information and
all other information supplied by Insulet; provided that [***]; and
provided further, that
Distributor may maintain a copy of Insulet’s Confidential Information for as
long as reasonably necessary to comply with applicable Laws. Upon
Termination of this Agreement, [***]
Section
11.4 Obligations of Distributor
upon Termination. Upon Termination of this Agreement and subject to
Section 11.3, Distributor shall immediately cease any and all use of the Product
Registrations and transfer to Insulet or its designee any Product Registration
not already in the name of Insulet or an Affiliate of Insulet with any rights
thereto that Distributor may then hold. To the extent not already owned by
Insulet, Distributor shall use commercially reasonable efforts to transfer such
Product Registration and rights without interruption or disruption to the
distribution, marketing or sales of the Products in the Territory.
ARTICLE
XII
General
Provisions
Section
12.1 Notices All notices,
requests, claims, demands, waivers and other communications under this Agreement
shall be in writing and shall be by facsimile, courier services or personal
delivery to the following addresses, or to such other addresses as shall be
designated from time to time by a Party in accordance with this Section
12.1:
if to
Distributor:
Ypsomed
Distribution AG
Xxxxxxxxxxxxxxxx
0
XX-0000
Xxxxxxxx
Xxxxxxxxxxx
Attention:
General Counsel
Facsimile:
++41/ 34 424 41 55
with a
copy (which shall not constitute notice) to:
Ypsomed
Distribution AG
Xxxxxxxxxxxxxxxx
0
XX-0000
Xxxxxxxx
Xxxxxxxxxxx
Attention:
Product Manager Infusion Systems
Facsimile:
++41/ 34 424 32 92”
if to
Insulet:
Insulet
Corporation
0 Xxx
Xxxx Xxxxx
Xxxxxxx,
XX 00000
Attention:
General Counsel
Facsimile:
000-000-0000
19
with a
copy (which shall not constitute notice) to:
Xxxxxxx
Procter LLP
Exchange
Place
Boston,
MA 02109
Attention:
Xxx Xxxxxx
Facsimile:
000-000-0000
All
notices and communications under this Agreement shall be deemed to have been
duly given (x) when delivered by hand, if personally delivered, (y) 1 Business
Day after when delivered to a courier, if delivered by commercial one-day
overnight courier service or (z) when sent, if sent by facsimile, with an
acknowledgment of sending being produced by the sending facsimile
machine.
Section
12.2 Definitions. For the
purposes of this Agreement, the following terms have the following
meanings:
“Affiliate” means, with respect to
any Person, any other Person controlling, controlled by or under direct or
indirect common control with such first Person. For purposes of this
definition, a Person shall be deemed to control another Person if it owns or
controls 50% or more of the voting equity of the other Person (or other
comparable ownership if the Person is not a corporation), or otherwise possesses
the power to direct the management or policies of the other Person, whether
through ownership of voting securities or by contract or otherwise; provided that solely for
purposes of this Agreement, no Party shall be deemed to be an “Affiliate” of any
other Party (or any of its Affiliates).
“Business Day” means any day
other than a Saturday or Sunday or a day on which banking institutions at the
domicile of Insulet or Distributor are permitted or required by Law, executive
order or decree of a Governmental Authority to remain closed.
“Business Plan” means a
description of the plan for marketing the Products in one or more countries of
the Territory (or proposed Territory) during the Term, including at least: (1)
the projected minimum sales quantities per quarter during the Term; (2) the
distribution route (direct or indirect), (3) the projected reimbursement
for the Products, (4) and any other information reasonably necessary for the
Parties to assess the commercialization of the Products in the specified
portions of the Territory or proposed Territory.
“Calendar Year” means the
period of 12 consecutive months starting on January 1, 2010, and each twelve
(12) months period thereafter.
“Calendar Quarter” means the
respective periods of 3 consecutive calendar months commencing on the first day
of the first Calendar Year.
[***]
20
“Competitor” means
[***]
“Confidential Information”
means all data and information of a confidential or proprietary nature,
including know-how and trade secrets relating to the business, the affairs and
the products of a Party. Confidential Information may be communicated
orally, in writing or in any other recorded or tangible form. Data and
information shall be considered to be Confidential Information, (a) if a Party
has advised the receiving Party of such confidential nature, or (b) if, due to
such character or nature, a reasonable person in a like position and under like
circumstances as the receiving Party would treat such as secret and
confidential.
[***]
“Customer” means a Person an
individual who (a) is resident in the Territory; and (b) has entered into an
agreement (oral or written, including purchase orders) for the purchase of
Products with Distributor.
“Force Majeure” has the
meaning as set forth in Section 12.8.
“Governmental Authority” means
any nation, state, province, county, city or political subdivision and any
official, agency, arbitrator, authority, court, department, commission, board,
bureau, instrumentality or other governmental entity of any thereof, whether
domestic or foreign.
“Intellectual Property Rights”
means, collectively, all rights in, to and under patents, trade secret rights,
copyrights, mask works, trademarks, service marks, trade dress and similar
rights of any type under the laws of any Governmental Authority, including,
without limitation, all applications and registrations relating to the
foregoing, which either Party may at any time own, control, license, adopt, use
or register with respect to the Products.
“Laws” shall mean any law,
statute, rule, regulation, guideline, ordinance or other pronouncement of any
Governmental Authority having the effect of law or guidances of any Governmental
Authority in the United States and in the countries of the Territory, or any
province, county, city or other political sub-division thereof.
“Person” means and includes
any individual, corporation, trust, estate, partnership, limited liability
company, joint venture company, association, league, governmental bureau or
agency, or any other entity regardless of the type or nature
thereof.
“Product Registrations” means
existing and future marketing and regulatory authorizations relating to the
Products in the Territory including such authorizations relating to any and all
existing and future uses for the Products, necessary for import, advertisement,
marketing, distribution and sale of the Products.
“Products” means certain
products as set forth in Exhibit I.
“Specifications” shall mean
the specifications for the Products that are included in the User Manual for
such Products.
21
“Sub-Distributor” means any
Third Party or any Affiliate of Distributor that has entered into a written
agreement with Distributor for the distribution of Products anywhere in the
Territory.
“Third Party” means any Person
other than Insulet, Distributor or their respective Affiliates.
Section
12.3 Descriptive Headings;
Certain Interpretations. The table of contents and headings contained in
this Agreement are for reference purposes only and shall not control or affect
the meaning or construction of this Agreement. Except where expressly
stated otherwise in this Agreement, the following rules of interpretation apply
to this Agreement: (a) ”or” is not exclusive and “include,”
“includes” and “including” are not limiting; (b) ”hereof,” “hereto,”
“hereby,” “herein” and “hereunder” and words of similar import when used in this
Agreement refer to this Agreement as a whole and not to any particular provision
of this Agreement; (c) “date hereof” refers to the date of this Agreement; (d)
“extent” in the phrase “to the extent” means the degree to which a subject or
other thing extends, and such phrase does not mean simply “if”; (e) definitions
contained in this Agreement are applicable to the singular as well as the plural
forms of such terms; (f) references to an agreement or instrument mean such
agreement or instrument as from time to time amended, modified or supplemented,
and all exhibits, appendices, schedules or other attachments thereto; (g)
references to a Person are also to its permitted successors and assigns; (h)
references to an “Article,” “Section,” “Clause,” “Exhibit” or “Schedule” refer
to an Article, Section or Clause of, or an Exhibit or Schedule to, this
Agreement; (i) words importing the masculine gender include the feminine or
neuter and, in each case, vice versa; (j) references to a Law include any
amendment or modification to such Law and any rules or regulations issued
thereunder, whether such amendment or modification is made, or issuance of such
rules or regulations occurs, before or after the date of this Agreement; and (k)
references to monetary amounts shall be denominated in United States
Dollars.
Section
12.4 Waivers. The waiver by either
Party of a breach or default in any of the provisions of this Agreement by the
other Party shall not be construed as a waiver of any succeeding breach of the
same of either Party to exercise or avail itself of any right, power or
privilege that it has or may have hereunder nor operates as a waiver of any
breach or default by the other Party.
Section
12.5 Entire Agreement and
Amendments. This Agreement
constitutes the entire agreement between the Parties with respect to the subject
matter hereof and supersedes all prior agreements between the Parties, whether
written or oral, relating to the same subject matter. No modification,
amendment or supplements to this Agreement shall be effective for any purpose
unless in writing, signed by each Party. Approvals or consents hereunder
of a Party shall also be in writing.
Section
12.6 Severability.
In the event that any provision herein shall be determined to be void or unenforceable in whole or in
part for any reason whatsoever, such unenforceability or invalidity shall not
affect the enforceability or validity of the remaining provisions or part
thereof contained in this Agreement and such void or unenforceable provisions
shall be deemed to be severable from any other provisions or part thereof herein
contained. In the event that any of the provisions herein contained are
held to be unreasonable by reason of the duration or type or scope of services
covered by the said provision then the said provision shall be given effect only
to the extent as may be enforceable or deemed enforceable by any court of
competent jurisdiction.
22
Section
12.7 Assignments. Neither Party shall
transfer or assign the Agreement or delegate the performance of its obligations
hereunder without the express written consent of the other Party.
Notwithstanding the foregoing, either Party may assign this Agreement (a) to any
of its Affiliates; or (b) to any Third Party in connection with the sale or
transfer, by merger, reorganization, consolidation or otherwise, of all or
substantially all of the Party’s business or assets to which this Agreement
relates. This Agreement and the provisions hereof shall be binding upon
and inure to the benefit of the Parties hereto and their respective successors
and permitted assigns.
Section
12.8 Force Majeure.
(a) Neither
Party shall be liable to the other Party for any delay or omission in the
performance of any obligation hereunder, where the delay or omission is due to
any cause or conditions beyond the reasonable control of the Party obligated to
perform, including strike or other labor difficulties, acts of God, acts of
government, war (declared or undeclared), acts of terrorism, fire, epidemic of
disease, riots, civil commotion, embargoes, government requisition or
impoundment or other acts of any Governmental Authority or inability to obtain
supplies (“Force
Majeure”). For clarification, failure to obtain or Maintain a Product
Registration shall not be considered a Force Majeure event. If Force Majeure
prevents or delays the performance by a Party of any obligation under this
Agreement, then the Party claiming Force Majeure shall notify the other Party
thereof in writing within 15 days of the occurrence of such Force
Majeure.
(b) If
the performance of this Agreement shall be prevented for a period exceeding six
months from the date of notice given pursuant to Section 12.8(a) due to an event
of Force Majeure, the Party receiving notice of an event of Force Majeure shall
be entitled to immediately terminate all obligations regarding the supply,
purchase or distribution of Products for the affected period by giving written
notice to the other. Distributor, if it is the Party receiving notice of
an event of Force Majeure, (instead of exercising its rights in the preceding
sentence) may elect to extend the Term of this Agreement for one additional
year. As regards the supply of Product for the remainder of the Term,
absent termination by the Party receiving notice of an event of Force Majeure,
this Agreement shall continue in full force and effect in accordance with its
terms.
Section
12.9 No Third-Party
Beneficiaries. This Agreement is for the sole benefit of the
Parties hereto and their permitted successors and assigns and nothing herein
express or implied shall give or be construed to give to any Person, other than
the Parties hereto and such successors and assigns, any legal or equitable
rights or remedies.
Section
12.10 Counterparts. This
Agreement may be executed in counterparts, each of
which shall be deemed an original but all of which shall constitute one and the
same instrument. Delivery of an executed counterpart of this
Agreement by facsimile or other electronic transmission shall be as effective as
delivery of a manually executed counterpart of this
Agreement.
23
Section
12.11 Further
Assurance. Each Party undertakes, at the request and cost and expense of
the other Party, to sign all documents and to do all other acts, which may be
necessary to give full effect to this Agreement.
Section
12.12 Governing Law. This
Agreement shall be governed by, and construed in accordance with, the
substantive Laws of Switzerland, excluding its conflicts of laws principles. The
UN Convention on Contracts for the International Sale of Goods is not applicable
to this Agreement nor to purchase orders and deliveries based hereon. General
terms of sale of Insulet and general order terms or purchase terms of
Distributor are not applicable to this Agreement nor to Orders based
hereon
Section
12.13 Governing Language.
The official text of this Agreement shall be the English language, and any
interpretation or construction of this Agreement shall be based thereon.
If this Agreement or any documents or notices relating to it are translated into
another language the English version shall be controlling in the event of
discrepancy between the two.
Section
12.14 Arbitration.
(a) In
the event of a dispute between the Parties, the Parties shall first attempt in
good faith to resolve such dispute by negotiation and consultation between
themselves. In the event that such dispute is not resolved on an
informal basis within 30 days for attempted resolution by good faith
negotiations within 30 days after such notice is received.
(b) All
disputes arising out of or in connection with this Agreement shall be finally
settled under the Rules of Arbitration of the International Chamber of Commerce
by one or more arbitrators appointed in accordance with the said Rules.
Such arbitration shall take place in Zurich, Switzerland. The language of
the arbitration shall be English. The arbitration award so given shall be
a final and binding determination of the dispute and shall not include any
damages expressly prohibited by Section 8.5. Except in a proceeding to
enforce the results of the arbitration or as otherwise required by Law, neither
Party nor any arbitrator may disclose the existence, content or results of any
arbitration hereunder without the prior written consent of both
Parties.
(c) Notwithstanding
the foregoing dispute resolution procedure, in the event of an actual or
threatened breach hereunder, the aggrieved Party may seek equitable relief
(including restraining orders, specific performance or other injunctive relief)
without submitting to such dispute resolution procedure if there is a reasonable
likelihood of the occurrence of irreparable harm during the period of the
dispute resolution procedure.
24
Section
12.15 Press
Releases.
(a) Subject
to Section 12.15(b), press releases or other similar public communications by a
Party relating to this Agreement shall be subject to a right of reasonable prior
review and approval by the other Party, which approval shall not be unreasonably
withheld or delayed, provided that such right of
approval shall not apply to communications required by applicable Law,
disclosures of information for which consent has previously been obtained, or
information that has been previously disclosed publicly, and provided, further, that any
draft press release or other public communication submitted to a Party for its
approval shall be deemed approved if such Party fails to notify the submitting
Party within [***] as to whether or not it has been approved.
(b) Distributor
understands and agrees that Insulet may submit a copy of this Agreement to the
United States Securities and Exchange Commission.
[Signature
Page Follows]
25
The
Parties have caused this Agreement to be executed by their respective duly
authorized officers as of the date first above written.
Insulet
Corporation
|
|
By:
|
/s/ Xxxxx XxXxxxx
|
Name:
Xxxxx XxXxxxx
|
|
Title:
Chief Executive Officer
|
|
Ypsomed
Distribution AG
|
|
By:
|
/s/ Xxxxxxx Xxxxxxxx
|
Name:
Xxxxxxx Xxxxxxxx
|
|
Title:
Chief Executive Officer
|
|
By:
|
/s/ Xxxxx Xxxxxx
|
Name:
Xxxxx Xxxxxx
|
|
Title:
Senior Vice President Marketing &
Sales
|
[Signature
Page to Distribution Agreement]
Exhibit
I
Products
1.
|
Insulet’s
OmniPod System, an insulin delivery system designed and manufactured by
Insulet and, pursuant to this Agreement, supplied to and distributed by
Distributor, each OmniPod System comprising a PDM (as defined hereafter)
and PODs (as defined hereafter). The term “Product(s)” includes
improvements, enhancements, new versions of and accessories to the
Products. Insulet shall use reasonable commercial efforts to make any
improved, enhanced or new versions of Products available to Distributor
for distribution in the Territory. The OmniPod System
includes:
|
|
a.
|
Personal
Diabetes Manager or PDM, the handheld portion of the OmniPod System,
containing the user interface for controlling the POD portion of the
OmniPod System, optionally including an integrated blood glucose
meter.
|
|
b.
|
POD,
the wearable, disposable insulin pump portion of the OmniPod System
(including filling system), controlled by the
PDM.
|
2.
|
“YM
OmniPod System” means a version of the OmniPod System, designed and
manufactured by Insulet and, pursuant to this Agreement, supplied to and
distributed by Distributor, each YM OmniPod System comprising a YM PDM (as
defined hereafter) and YM PODs (as defined hereafter). Insulet shall use
reasonable commercial efforts to make the YM OmniPod System ready for
supply to Distributor and ready for distribution in the Territory by the
dates set forth in Exhibit II.
|
“YM PDM” means versions of
Insulet’s PDM adapted and labeled for sale in the countries of the Territory
listed in Section II of Exhibit II.
“YM POD” ” means versions of
Insulet’s POD adapted and labeled for sale in the countries of the Territory
listed in Section I of Exhibit II.
“YM
Integrated BGM” means a blood glucose meter that uses blood glucose strips
manufactured by [***] and is integrated into the YM PDM.
The terms
“PDM” and “POD” include the terms “YM PDM” and “YM POD” where
appropriate.
Exhibit
II
Territory
I.
|
TERRITORY
|
Those
countries listed below in Section II of this Exhibit II.
II.
|
LIST OF
COUNTRIES
|
The
following countries shall be ready for distribution of Products by Distributor
on the dates specified below, i.e. Insulet shall have obtained and maintain
Product Registrations in these countries and shall have the country specific
version of Products ready for supply and ready for distribution by Distributor
as of the date specified below.
|
-
|
Germany:
[***] 0000
|
|
-
|
Xxxxxxxxxxx:
[***] 0000
|
|
-
|
Xxxxxx:
[***] 2010
|
|
-
|
Australia:
[***] 2010
|
|
-
|
Belgium:
[***] 2010
|
|
-
|
China:
[***] 2011
|
|
-
|
UK:
[***] 0000
|
|
-
|
Xxxxxx:
[***] 0000
|
|
-
|
Xxxxxx:
[***] 0000
|
|
-
|
Xxxxxxx:
[***] 0000
|
|
-
|
Xxxxxxxxxxx:
[***] 2010
|
III.
|
INCLUSION OF
ADDITIONAL COUNTRIES FOR
DISTRIBUTION
|
1.
|
At
any time during the term, Distributor may request Insulet in writing to
add further countries to the list of countries in the Territory in Section
II of Exhibit II. Distributor shall present a Business Plan for the
distribution of the Products in each such additional country(ies).
Insulet and Distributor shall negotiate in good faith to enter into an
amendment of this Exhibit II relating to the addition of each such
country(ies) to the Territory and [***] Minimums [***] If the
Parties agree to add any such country(ies) to the list of countries in the
Territory in Section II of Exhibit II, the Parties shall
[***]
|
IV.
|
[***]
|
1.
|
[***]
|
2.
|
[***]
|
V.
|
COUNTRIES EXCLUDED
FROM THE TERRITORY
|
1.
|
The
Parties agree the countries listed below shall not be part of the
Territory and Distributor waives its right to (a) add such countries to
the Territory under Section III of this Exhibit II, and (b) negotiate and
have a right of first refusal with respect to such countries under Section
IV of this Exhibit II.
|
|
-
|
USA
|
|
-
|
Israel
|
|
-
|
Canada
|
Exhibit
III
[***] Minimums And
Pricing
I.
|
[***] MINIMUMS AND
PRICING
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
[***]
[***]
|
[***]
|
II.
|
[***]
|
[***]
III.
|
[***]
|
[***]
[***]
[***]
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
EXHIBIT
IV
[***]
[***]
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
EXHIBIT
V
Business
Plans