Exhibit 10.1

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.

 

 

 

 

 

DEVELOPMENT AGREEMENT

 

 

by and between

 

 

 

SOPHIRIS BIO CORP.

 

and

 

VETTER PHARMA INTERNATIONAL GMBH 

 

 

 

 

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— ii —

 

TABLE OF CONTENTS

 

1:

DEFINITIONS

  1

     

2:

SERVICES

  4

     

3:

REPRESENTATIONS AND WARRANTIES BY CUSTOMER

  5

     

4:

CONFIDENTIALITY

5

     

5:

MATERIALS

  6

     

6:

CUSTOMER INSPECTIONS

7

     

7:

DEFECTS AND RECALLS

  7

     

8:

PURCHASE ORDERS AND DELIVERY

  8

     

9:

PRICES AND PAYMENTS

  9

     

10:

APPROVALS, AUDITS AND CHANGES

  9

     

11:

INTELLECTUAL PROPERTY

10

     

12:

INDEMNIFICATION, INSURANCE AND LIABILITY

11

     

13:

WARRANTIES

13

     

14:

TERM AND TERMINATION

13

     

15:

MISCELLANEOUS

14

       

SIGNATURE PAGE

19

 

 

 

 

ANNEXES

 

ANNEX 1: STATEMENT(S) OF WORK     ANNEX 2:   DEVELOPMENT QUALITY AGREEMENT    
ANNEX 3: CONFIDENTIALITY AGREEMENT

          

 

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THIS DEVELOPMENT AGREEMENT (the “Agreement”) is made and entered into as of the
23rd day of January, 2018 (“Effective Date”), by and between Sophiris Bio Corp.,
a company duly organized and existing under the laws of Delaware and having its
principal place of business at 1258 Prospect Street, La Jolla, California 92037
(“Customer”), and Vetter Pharma International GmbH, a company duly organized and
existing under the laws of Germany, having its principal place of business at
Eywiesenstraße 5, 88212 Ravensburg, Germany (“Vetter International”), Customer
and Vetter International also being referred to herein individually as a “Party”
and collectively as the “Parties”.

 

W I T N E S S E T H:

 

WHEREAS, Vetter International is a specialist in providing services for aseptic
filling and the packaging of compounds into syringes, vials, and cartridges; and

 

WHEREAS, Customer desires Vetter International to perform certain services for
the development of its compounds for use in its clinical trials and other
non-commercial uses within the applicable Territory;

 

NOW, THEREFORE, in consideration of the premises and of the mutual covenants and
agreements hereinafter set forth, and subject to the provisions of this
Agreement, Customer and Vetter International agree as follows:

 

1.

Definitions. For all purposes of this Agreement, and all amendments thereto, the
following capitalized terms, whether used in singular or plural, will have the
definitions set forth below, unless otherwise stated:

 

 

1.1.

“Affiliate” shall mean, with respect to Customer, any person, firm, company, or
entity which is directly or indirectly controlled by Customer, and with respect
to Vetter International, any person, firm, company, or entity which is under
common control of the trustees/executors of the estate of Helmut Vetter. For all
purposes hereof, “control” shall mean owning more than fifty percent (50%) of
the voting stock or interests.

 

 

1.2.

“Agreement” shall have the meaning in the preamble.

 

 

1.3.

“API” shall mean the active pharmaceutical ingredient that is identified in the
applicable Statement of Work.

 

 

1.4.

“API Invention” shall have the meaning set forth in Section 11.2.

 

 

1.5.

“Applicable Law” shall mean any law, statute, ordinance, rule, regulation, order
or determination of any governmental agency or authority in the applicable
jurisdiction.

 

 

1.6.

“Business Day” shall mean any calendar day other than a Saturday, a Sunday or a
calendar day on which commercial banks located in either Baden-Wuttemberg,
Germany or Skokie, Illinois, USA, are closed.

 

 

1.7.

“Change” shall have the meaning set forth in Section 10.4.

      

 

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1.8.

“Confidential Information” shall have the meaning set forth in that certain
Confidentiality Agreement.

 

 

1.9.

“Confidentiality Agreement” shall mean that certain confidentiality agreement
between Customer and Vetter International, or any of its Affiliates, dated 15
February 2017 and incorporated and attached hereto as Annex 3.

 

 

1.10.

“Customer Indemnitees” shall have the meaning set forth in Section 12.1.

 

 

1.11.

“Customer Material” shall mean any materials (including API) listed as customer
materials in any Specifications or Statement of Work, and any other materials or
items supplied under this Agreement by or on behalf of Customer, including
information and documentation pertaining to manufacturing and handling
specifications and requirements, testing procedures, GMP requirements and other
technical information concerning the Manufacture of Product, as provided by, on
behalf of, or directed by, Customer.

 

 

1.12.

“Deliverables” shall have the meaning set forth in Section 11.4.

 

 

1.13.

“Development Quality Agreement” shall mean the mutually agreed Development
Quality Agreement, including all of its appendices, separately executed by the
Parties and effective as of January 23, 2019.

 

 

1.14.

“Development Schedule” shall mean the mutually agreed upon plan for the
Manufacture of the Product, attached as an annex to the applicable Statement of
Work and incorporated herein by reference.

 

 

1.15.

“Effective Date” shall have the meaning in the preamble.

 

 

1.16.

“EMA” shall mean the European Medicines Agency, or any successor agency.

 

 

1.17.

“Equipment” shall mean the dedicated equipment listed and attached as an annex
to the applicable Statement of Work or Budgetary Quotation, and incorporated
herein by reference, for the Manufacture of the Product.

 

 

1.18.

“Facility” shall mean any of the facilities and non-dedicated equipment therein
utilized by Vetter International for the Manufacture of the Product, either
located in or near Ravensburg, Germany, Langenargen, Germany, or Skokie,
Illinois, USA .

 

 

1.19.

“FDA” shall mean the United States Food and Drug Administration, or any
successor agency.

 

 

1.20.

“Force Majeure” shall have the meaning set forth in Section 15.2.

 

 

1.21.

“GMP” means good manufacturing practices as applicable for the Services in each
jurisdiction in the Territory.

 

 

1.22.

“Information” shall have the meaning set forth in the Confidentiality Agreement.

 

 

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1.23.

“Information of Customer” means all information provided by or on behalf of
Customer, including information pertaining to the manufacturing, handling,
testing procedures and other technical information regarding the Manufacture of
the Product.

 

 

1.24.

“Losses” shall have the meaning set forth in Section 12.1.

 

 

1.25.

“Manufacture” means the manufacturing activities performed by Vetter
International and its Affiliates and in accordance with the Specifications.

 

 

1.26.

“Manufacture Invention” shall have the meaning set forth in Section 11.3.

 

 

1.27.

“Parties” shall mean Customer and Vetter International, and “Party” shall mean
either thereof.

 

 

1.28.

“Product” means the various application systems, pre-filled with the API and the
result of the Manufacture Services.

 

 

1.29

“Regulatory Approvals” means any and all approvals, consents, permissions, and
the like, required by law or under the terms of this Agreement to be obtained
and maintained by Customer in order to Manufacture, use (including use in
clinical trials), import, export, distribute, market, promote or sell the
Product within the Territory.

 

 

1.30

“Representatives” shall mean any Affiliate and/or any employee, officer,
director and trustee/executor of a Party and/or an Affiliate.

 

  1.31  “Rules” shall have the meaning set forth in Section 15.11.

 

  1.32  “Services” shall have the meaning in Section 2.1, including
Manufacturing of Product.

 

 

1.33

“SOPs” shall mean Vetter International’s or its Affiliates’ standard operating
procedures as applicable to the Manufacture of the Product.

 

 

1.34

“Specifications” shall mean the process development specifications, as agreed
upon between the Parties and set forth in the DQA, for the Manufacture of the
Product by Vetter International.

 

 

1.35

“Statement of Work” shall have the meaning set forth in Section 2.1

 

 

1.36

“Territory” shall mean worldwide except Japan.

 

 

1.37

“Vetter International” shall have the meaning set forth first above.

 

 

1.38

“Vetter International Indemnitees” shall have the meaning set forth in Section
12.2.

 

  1.39  “Vetter International Property” shall have the meaning set forth in
Section 11.4.

 

 

1.40

“Vetter Materials” shall mean the materials, equipment and other resources
utilized by Vetter International for the performance of the Services.

 

 

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1.41

“Vetter Pharma” shall mean Vetter Pharma-Fertigung GmbH & Co. KG, a company duly
organized and existing under the laws of Germany, having its principal place of
business at Schützenstraße 87, 88212 Ravensburg, Germany, an Affiliate of Vetter
International.

 

 

1.42

“Warehouse” shall mean the warehousing facilities of Vetter Pharma located at
Helmut-Vetter-Straße 10, 88213 Ravensburg, Germany, as directed by Vetter
International in writing.

 

2.

Services.

 

 

2.1.

From time to time, Customer may engage Vetter International to provide certain
development and manufacturing related services (“Services”). This Agreement
contains general terms and conditions under which Customer will engage Vetter
International. Vetter International and Customer will complete and execute a
statement of work (each, a “Statement of Work”) before any Services are
rendered. Each Statement of Work will, at a minimum, detail the API, a
description of the Services provided, and the payment schedule. If applicable,
the Parties will execute a Development Quality Agreement in connection to the
API and the Services provided prior to the commencement of any Services. Once a
Statement of Work is executed, a Statement of Work becomes part of, and subject
to, this Agreement. A Statement of Work may not change any term in this
Agreement. Statements of Work will be attached to this Agreement as Annex 1.

 

 

2.2.

Performance. Vetter International agrees to use best commercial efforts to
provide all Services identified in any Statement of Work: (a) within the time
period specified in the applicable Statement of Work, (b) in accordance with all
Applicable Laws, rules and regulations and (c) in accordance with the highest
prevailing industry standards and practices for the performance of similar
services at the Facility. However, it is understood and agreed that Vetter
International makes no guaranty and no warranty (i) that the dates and timelines
referenced in any document or agreed upon by the Parties will be met and (ii) as
to the outcome of the Services or success in achieving Customer's objectives,
any anticipated results and/or any target, whether set forth in this Agreement,
any Statement of Work, the Specifications or any other document.

 

 

2.3.

Subcontracting. Vetter International will supply the Product to Customer in
accordance with the terms of this Agreement. Customer acknowledges that Vetter
International may subcontract any and all portions of the Services to Vetter
Pharma. Further, Vetter International may subcontract internal logistic and
warehousing operations to […***…]. Vetter International will remain liable for
any performance of or failure to perform by Vetter Pharma, and […***…]. Other
than these named sub-contractors, Vetter shall not sub-contract with any other
entities without a prior written agreement from Customer consenting to such
sub-contractor.

 

 

2.4.

Equipment. Vetter International will procure, either directly or by its
Affiliates, Equipment for the performance of the Services as provided in the
applicable Statement of Work. The Equipment will be dedicated to and paid for by
Customer and Vetter agrees that the Equipment will only be used for the
manufacture of Customer’s Product. The title of the Equipment will belong to and
be insured by Vetter Pharma and Vetter Pharma will maintain and operate the
Equipment in accordance with its SOPs at Vetter International’s expense,
provided, however, that any costs related to the repair or replacement of any
Equipment will be borne by Customer. Any costs for the procurement, repair or
replacement of any Equipment will be invoiced by Vetter Pharma.

 

 

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2.5.

Statement of Work Amendments. If the scope of work under a Statement of Work
materially changes, then the applicable Statement of Work may be amended as
provided in this Section 2.5. If Vetter International or Customer identifies
that a modification to the Statement of Work is necessary, the identifying Party
will notify the other Party as soon as reasonably possible. The Parties will
agree on an amendment to the Statement of Work, which will not be effective
unless and until it has been signed by an authorized representative of each
Party. If practical, Vetter International will continue to provide Services
under the existing Statement of Work while an amendment to the Statement of Work
is finalized and executed.

 

3.

Representations and Warranties.

 

3.1      Customer makes the following representations and warranties, and agrees
to notify Vetter International in writing immediately upon learning of any
future breach of these representations and warranties:

 

3.1.1 Organization of Customer. Customer is and will remain a corporation duly
organized, validly existing and in good standing under the laws of its
jurisdiction of organization.

 

3.1.2     Enforceability of this Agreement. The execution and delivery of this
Agreement has been authorized by all requisite corporate action. This Agreement
is and will remain a valid and binding obligation of Customer, enforceable in
accordance with its terms, subject to laws of general application relating to
bankruptcy, insolvency and the relief of debtors.

 

3.1.3     Absence of Other Contractual Restrictions. Customer is under no
contractual or other obligation or restriction that is inconsistent with
Customer’s execution or performance of this Agreement. Customer will not enter
into any agreement, either written or oral, that would conflict with Customer’s
responsibilities under this Agreement.

 

3.1.4     Conflicts with Rights of Third Parties. To the best of Customer’s
knowledge, the use of Customer Materials under this Agreement will not violate
any patent, trade secret, or other proprietary or intellectual property of any
third party.

 

 

3.2

Vetter makes the following representations and warranties, and agrees to notify
Customer in writing immediately upon learning of any future breach of these
representations and warranties:

 

3.2.1     Organization of Vetter International. Vetter International is and will
remain a corporation duly organized, validly existing and in good standing under
the laws of its jurisdiction of organization.

 

3.2.2     Enforceability of this Agreement. The execution and delivery of this
Agreement has been authorized by all requisite corporate action. This Agreement
is and will remain a valid and binding obligation of Vetter Internationnal,
enforceable in accordance with its terms, subject to laws of general application
relating to bankruptcy, insolvency and the relief of debtors.

 

 

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3.2.3     Absence of other Contractual Restrictions. Vetter International is
under no contractual obligation or restriction that is inconsistent with
Vetter’s execution or performance of this Agreement. Vetter will not enter into
any agreement, either written or oral, that would conflict with Vetter’s
responsibilities under this Agreement.

 

3.2.4     Conflicts with Rights of Third Parties. To the best of Vetter
International’s knowledge, the use of Vetter Materials under this Agreement will
not violate any patent, trade secret, or other proprietary or intellectual
property of any third party.

 

3.2.5     Warranty of Vetter Supplied Materials. Vetter International warrants,
on behalf of itself and its Affiliates, that all Vetter Materials utilized
hereunder for human use are in compliance with GMP, Agreed Specifications and
the agreed manufacturing process.

 

4.

Confidentiality. The provisions of that certain Confidentiality Agreement will
govern this Agreement in every respect (and the term Purpose (as therein
defined) will be deemed to include the matters set forth or contemplated in this
Agreement), except that the confidentiality obligations in the Confidentiality
Agreement contained shall survive the expiration or early termination of this
Agreement and shall remain in full force and effect for a period of ten (10)
years from the effective date of termination or expiration of the Agreement.

 

5.

Materials.

 

 

5.1.

Materials. Customer will timely deliver, or have delivered, to the Facility as
directed by Vetter International, free of any charge to Vetter International and
at the sole risk to Customer, Customer Materials in sufficient quantities to
enable Vetter International to perform the Services. If applicable, Customer
Materials will be accompanied with certificates as reasonably requested by
Vetter International or any of its Affiliates. All associated intellectual
property rights of the Customer Materials will remain the exclusive property of
Customer. Customer will provide information with respect to the Customer
Materials, specifically the API, as Vetter International or its Affiliates may
request. Customer will be responsible for obtaining any adequate insurance for
the Customer Materials.

 

 

5.2.

Delay. In the event the Customer Materials are not timely delivered as directed
by Vetter International for any reason, Vetter International may reasonably
determine, in its sole discretion and after consulting with Customer, a new
delivery date for the Product.

 

 

5.3.

Testing. All Vetter Materials and all Customer Materials will be tested in
accordance with the Development Quality Agreement or Vetter International’s
SOPs.

 

 

5.4.

Use. Vetter International and its Affiliates will use the Customer Materials
solely for the Services and for no other purpose. Vetter International will
notify Customer in writing of any surplus Customer Materials at the completion
of the Services and, at Customer’s option and expense, will be either (i)
disposed of, (ii) returned to the Customer, or (iii) handled in accordance with
Customer’s written directions. At Customer’s written request, Vetter
International will provide Customer copies of an inventory of Customer Materials
stored at the Facility.

 

 

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5.5.

Liability for Materials. Neither Vetter International nor any of its Affiliates
will be liable for any Customer Materials supplied to the Facility by or on
behalf of Customer, including any testing or other services performed by any
third party; provided however, that Vetter International will transfer, or cause
to transfer, to Customer any warranties received in respect of any of the
foregoing.

 

6.

Customer Inspections.

 

 

6.1.

Inspection. Customer will inspect the Product and review the accompanying batch
documentation without delay, but in no event later than […***…] calendar days
upon Customer’s receipt of either the Product or the batch documentation,
whichever is received by Customer first. If either the Product or the batch
documentation does not pass inspection by Customer, Customer will promptly
notify Vetter International in writing. Customer will, as instructed by Vetter
International, either return the rejected Product to the assigned Facility or
dispose of the Product.

 

 

6.2.

Acceptance. Any Product or batch documentation not rejected as set forth in
Section 6.1 above will be deemed accepted by Customer, to the extent that either
the Product or batch documentation may contain any non-latent defect. Any
Product or batch documentation that contains any latent defect will be deemed to
be accepted by Customer unless Customer gives prompt written notice to Vetter
International within a period no later than […***…] months after delivery of the
batch documentation and Product.

 

 

6.3

Standard. With the exception of any deviations, of which Customer will be
notified in writing as set forth in the Development Quality Agreement, all
Product made available to Customer under this Agreement will have been
Manufactured in accordance with the Specifications, Vetter’s SOP’s, under GMP
conditions (if applicable), the Development Quality Agreement and the approved
master batch records. Customer acknowledges that Vetter International and its
Affiliates will not be found to be negligent so long as it can be shown by
written documentation that the Product was Manufactured in accordance with the
Specifications, Vetter’s SOP’s, GMP (if applicable), the Development Quality
Agreement and the approved master batch records.

 

7.

Defects and Recalls.

 

 

7.1.

Defects. If Product has been rejected pursuant to Section 6.1, Vetter
International will supply Customer with replacement Product and provide the
corresponding batch documentation. If required, Customer will supply, or have
supplied, sufficient quantities of Customer Materials for the replacement
Product. Vetter International will not be responsible for the disposal of
defective Product or to supply replacement Product, unless the defect is due to
Vetter International’s (a) gross negligence to supply the Product or provide the
batch documentation as required in this Agreement, (b) material breach of this
Agreement, or (c) willful misconduct or violation of Applicable Laws, in which
case, following Customer’s provision of additional API, Vetter International
agrees to replace the Product without additional cost to Customer for the
replacement Product. The obligations of this Section shall survive expiration or
termination of this Agreement. Apart from supplying replacement Product as
above, there will be no further payment or reimbursement by Vetter International
or any of its Affiliates in connection to the defective Product and the
replacement Product.

 

 

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7.2.

Recall. If a recall or return of the Product results from the Products’
non-conformity with the Specifications, the Development Quality Agreement, this
Agreement, GMP, or Applicable Laws, or is initiated by a regulatory authority,
and such non-conformity arose due to Vetter International’s or its
Affiliates’gross negligence, Vetter International will, upon Customer’s written
request, use commercially reasonable efforts to replace the recalled or returned
Product with new Product, contingent upon receipt of API and other necessary
Customer Materials required for the Manufacture of the replacement Products;
provided, however, that Vetter International’s liability under this Section 7.2
will not exceed the limitations set forth in Section 12.

 

8.

Purchase Orders and Delivery.

 

 

8.1.

Purchase Orders. Customer will issue purchase orders to Vetter International
pursuant to the applicable Statement of Work. The Product will be released on
the Business Day specified by Customer and approved by Vetter International;
however, if a Business Day is not specified or approved, then Vetter
International will, in good faith, determine the month for release of the
Product. The date of release requested by Customer will be no earlier than
[…***…] calendar days after receipt of the purchase order by Vetter
International. Vetter International will confirm receipt of the purchase order
within […***…] Business days of its receipt of the purchase order; provided,
however, that Vetter International may reject the purchase order if the Services
have not progressed to ensure timely Manufacture of the Product. This Agreement
will supersede any terms and conditions contained in the purchase order.

 

 

8.2.

Cancellation or Rescheduling. In the event Customer cancels a purchase order, or
reschedules any Services set forth in the applicable Statement of Work, the
following fees will apply:

 

Cancellation or delay within […***…] calendar days of a scheduled batch run

Customer pays […***…] percent ([…***…] %) of the quoted batch price.

Cancellation or delay between […***…]  and […***…] calendar days of a scheduled
batch run

Customer pays […***…] percent ([…***…] %) of the quoted batch price.

Cancellation or delay between […***…] and […***…] calendar days of a scheduled
batch run

Customer pays […***…] percent ([…***…] %) of the quoted batch price.

 

 

 

8.3. 

Delivery. All Product released by Vetter International will be delivered Ex
Works Warehouse (EXW Incoterms® 2010). Product will be deemed to be delivered
and ready for collection by Customer upon written notification to Customer.
Customer will collect the Product released by Vetter International or its
Affiliates no later than […***…] calendar days upon receipt of written
notification (“Collection Period”), until which time Vetter International will
maintain the Product in storage at no cost to Customer but at Customer’s risk.

 

 

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8.4.

Warehousing. Unless otherwise agreed between the Parties, if the Product is not
collected by Customer within the Collection Period, Vetter International will
store the Product at the Facility at Customer’s risk and in accordance with
Vetter International’s SOPs until a revised collection date is agreed upon by
the Parties. Following the Collection Period and until Product is collected by
Customer, Customer will pay storage fees at a rate of […***…] Euros (€[…***…] )
per pallet per month of 2-8°C refrigerated storage, or […***…] Euros (€[…***…] )
per pallet per month of controlled ambient storage.

 

 

8.5.

Delivery Assistance. In addition to Section 8.3 above, Vetter International and
its Affiliates may, at its option and at Customer’s request with Customer
bearing the cost and risk, provide assistance with (i) addressing special
shipping requirements; (ii) obtaining licenses, official authorizations,
clearances, customs, any other documents or information, including security
related information that Customer may require for export, import, or transport
of the Product to its final destination; (iii) making a contract for transport
or insurance; or (iv) loading the packed Product in any container, collecting
vehicle or other means of transport. At Vetter International’s request, Customer
will provide information for taxation or reporting purposes with respect to the
export of Product.

 

 

8.6.

Quarantine Shipments. Product may be shipped under quarantine upon prior written
request by Customer and such written request will serve as conclusive notice by
Customer that (i) Product is delivered and ready for collection by Customer,
notwithstanding Section 8.3; and (ii) Customer assumes all risks and liabilities
associated with the quarantine shipment.

 

9.

Prices and Payments.

 

 

9.1.

Price. Customer will pay Vetter International in the amounts set forth in the
applicable Statement of Work, plus any applicable taxes, VAT, customs, fees and
other duties. In the event of any change to the Services contained in a
Statement of Work, both Parties will enter into good faith negotiations for any
price adjustments. Vetter International reserves the right to reasonably change
its prices due to any change in circumstances, such as, for instance, due to a
revision of regulatory requirements or a change to the prices for Vetter
Materials; provided, however, that in the event of a price increase in excess of
[…***…] percent, Customer shall have the right to terminate this Agreement
and/or any Statement of Work according to the terms of Section 14.2, below, and
without a termination penalty payment, so long as such increase does not result
from a change in project scope made by Customer.

 

 

9.2.

Payment. Vetter International will issue an invoice upon delivery of Product as
set forth in Section 8. Payments will be made in the currency set forth in the
invoice and due […***…] calendar days from the date of receipt of the invoice.
If Customer does not pay the invoice within […***…] calendar days from the date
of receipt of the invoice, Vetter International will have the right to add
interest to the invoiced amount at a rate of […***…] percent ([…***…]%) per
annum, unless Customer has given notice of a dispute of the invoiced amount in
good faith.

 

10.

Approvals, Audits and Changes.

 

 

10.1.

          Regulatory Contact. Customer will be responsible for obtaining and
maintaining, at its cost and risk, all Regulatory Approvals for the Services.
Customer will not distribute or otherwise use the Product, either for clinical
or commercial purposes, without first obtaining Regulatory Approval, as legally
required. Vetter International and its Affiliates will reasonably cooperate, at
Customer’s expense, to provide information and other documentation with respect
to Regulatory Approvals.

 

 

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10.2.

          Facility. Vetter International will ensure that all Affiliates or
subcontractors pre-approved by Customer in writing, including but not limited to
Vetter Pharma, shall obtain and maintain the necessary manufacturing
authorization with respect to the Facility or the authorized facility, by the
applicable German health authority in accordance with the German Medical Act
(Arzneimittelgesetz) and, upon written request by Customer, Vetter International
will make available a copy of such authorization. Customer acknowledges that
certain regulatory authorities may have to approve the Manufacture of the
Product, at Customer’s expense.

 

 

10.3.

          Audits. Vetter International will promptly, as legally permitted,
notify Customer of any audit by a regulatory authority that relate directly to
the Product and, if legally permitted, arrange for a representative of Customer
onsite for all Product specific or pre-approval inspections. For audits
performed by a regulatory agency, such as the FDA, EMA, or Germany health
authorities, and the audit relates directly to the Product, the audit will be
performed at Customer’s expense; provided, however, that in the event an audit
takes place by a regulatory authority and the audit is not directly related to
the Product, Customer will not be responsible for the associated costs.

 

 

10.4.

          Change Control. All changes to the Development Quality Agreement (each
a “Change”) will be processed in accordance with the change control procedures
set forth in the applicable Development Quality Agreement, subject to this
Section 10.4 and Section 10.5. The Parties agree that the cost of any Change
which does not result from Vetter International’s discretionary decision will be
the responsibility of the Customer unless such Change is not specific to
Customer’s Product, in which case the cost of such Change will be borne by the
Customer only in proportion to the Product’s utilization of total Facility
capacity.

 

 

10.5.

          Change Dispute. In the event of a good faith dispute regarding a
Change, Customer and Vetter International will discuss in good faith a
resolution for the dispute; provided, however, that Vetter International and its
Affiliates will not be required to commence with the Services affected by the
Change, without breaching this Agreement, until the dispute is resolved.

 

11.

Intellectual Property.

 

 

11.1.

          Existing Intellectual Property. Each Party shall continue to own all
of its intellectual property (including patents, trademarks, trade secrets,
know-how, industrial design, and other intellectual property) existing on or
before the Effective Date (“Pre-Existing IP”), and neither Party nor any third
party will acquire any right, title or interest in or to any Pre-Existing IP of
the other Party, except that Customer hereby grants to Vetter International and
its Affiliates a non-exclusive license to Customer Materials and to Customer
Pre-Existing IP solely for purposes of Vetter International and its Affiliates‘
performance of the Services.

 

 

11.2.

          API Inventions. Any inventions, improvements, discoveries or
enhancements, whether or not patentable, and all associated intellectual
property, that (a) are generated, developed, conceived, discovered, or reduced
to practice by or on behalf of Vetter International or its Affiliates and arise
from or are made in the course of performance of the Services, (b) are in
connection to the API or to Customer drug substance-specific processes, programs
or materials provided by Customer and/or are specific to the Product, and (c) do
not incorporate any of Vetter International Confidential Information (“API
Inventions”) will be owned by Customer, and Vetter International agrees to
assign and hereby assigns to Customer all rights in Germany, the United States,
and throughout the world.

 

 

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11.3.

          Manufacturing Inventions. Any inventions, improvements, discoveries or
enhancements, whether or not patentable, and all associated intellectual
property, that (a) are generated, developed, conceived, or discovered, or
reduced to practice by or on behalf of Customer and arise from or are made in
the course of performance of the Services, (b) do not contain any API
Inventions, and (c) do not incorporate any of Customer Confidential Information
(“Manufacturing Inventions”) will be owned by Vetter International, and Customer
agrees to assign and hereby assigns to Vetter International all rights in
Germany, the United States, and throughout the world, provided, however, that
Vetter International shall (i) grant to Customer a royalty-free, sublicenseable,
worldwide license for the use of such Manufacturing Invention in the manufacture
of the Product by any manufacturer and (ii) provide commercially reasonable
assistance to Customer, at Customer’s expense, in the transfer of such licensed
Manufacturing Invention to Customer’s designated manufacturer. For the avoidance
of doubt, the foregoing obligations of license grant and assistance by Vetter
International do not require the transfer to Customer of, or to grant to
Customer a license either express or implied for the use or practice of, any
Vetter International Pre-existing IP.

 

 

11.4.

          Deliverables. Vetter International and its Affiliates agree to assign,
and hereby assign, to Customer all of its right, title and interest in and to
the Product and batch documentation (collectively, “Deliverables”). Vetter
International and its Affiliates appoints Customer its attorney-in-fact to
execute and deliver any documents on behalf of Vetter International and its
Affiliates for Customer to perfect and enforce its rights to the Deliverables.
Notwithstanding the foregoing, Vetter International and its Affiliates will
retain full ownership rights in and to all templates, programs, processes, and
other materials developed or obtained or licensed from third parties by Vetter
International and its Affiliates (which for the avoidance of doubt do not
include processes, programs and materials provided by Customer to enable Vetter
International to provide the Services) prior to or independent of the
performance of its obligations under this Agreement (“Vetter International
Property”), regardless of whether such Vetter International Property is used in
connection with Vetter International’s performance of the Services.

 

12.

Indemnification, Insurance and Liability.

 

 

12.1.

          Indemnification by Vetter International. Vetter International agrees
to indemnify Customer and its directors, officers, and employees (collectively,
“Customer Indemnitees”) from and against any and all liability, loss, damage,
cost, and expense, including reasonable attorneys’ fees and costs (collectively,
“Losses”) they may suffer in connection with any claim or lawsuit brought by a
third party arising from a Vetter International Indemnitee’s (defined below)
(a) gross negligence or willful misconduct; or (b) breach of this Agreement or
Applicable Laws, rules and regulations..

 

12.2          Indemnification by Customer. Customer agrees to indemnify Vetter
International and its directors, officers and employees, and Vetter
International’s Affiliates’ directors, officers and employees (collectively, the
“Vetter International Indemnitees”) from and against any and all Losses they may
suffer in connection with any claim or lawsuit brought by a third party arising
from (a) Customer’s transport, storage, promotion, labeling, marketing,
distribution, sale, or use of the Product; (b) Customer’s gross negligence or
willful misconduct; (c) Customer’s breach of this Agreement; (d) any claim that
the use, sale, Manufacturing, marketing or distribution of Product or Customer
Materials by Vetter International or its Affiliates, excluding the use of Vetter
International’s intellectual property, violates the patent, trademark, copyright
or other intellectual property rights of any third party;

 

 

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12.3          Indemnification Procedures. Each Party agrees to notify the other
party within […***…] days of receipt of any claims made for which the other
Party might be liable under Section 12.1 or 12.2, as the case may be. The
indemnified Party will be entitled to participate in the defense of such matter
and to employ counsel at its expense to assist therein; provided, however, that
the indemnifying Party will have final decision-making authority regarding all
aspects of the defense of any claim. The Party seeking indemnification will
provide the indemnifying Party with such information and assistance as the
indemnifying Party may reasonably request, at the expense of the indemnifying
Party. Neither Party will be responsible or bound by any settlement of any claim
or suit made without its prior written consent; provided, however, that the
indemnified Party will not unreasonably withhold or delay such consent. If a
settlement contains an absolute waiver of liability for the indemnified Party,
and each Party has acted in compliance with the requirements of this Section
12.3, then the indemnified Party’s consent will be deemed given.

 

12.4          Insurance. Customer shall self-insure or maintain product
liability insurance coverage with a reputable international insurance company,
of at least […***…] US Dollars per each calendar year during the term of this
Agreement and for […***…] thereafter. Vetter International and its Affiliates
shall maintain product liability insurance coverage (to the extent commercially
reasonable), with a reputable insurance company, in the aggregate of […***…]
Euros per each calendar year during the term of this Agreement, with […***…]
Euros per personal injury and […***…] Euros per property damage, which coverage
shall include attorneys’ fees and court fees. Upon request of the other Party,
each Party shall provide a Certificate of Insurance evidencing such coverages
and providing […***…] calendar days advance written notice for any material
change or cancellation in coverage of limits.

 

12.5               Liability.

 

12.5.1     Limitation. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE
CONTRARY, IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY SPECIAL, INCIDENTAL,
CONSEQUENTIAL, PUNITIVE OR INDIRECT DAMAGES INCLUDING WITHOUT LIMITATION, LOST
PROFITS, ARISING OUT OF THIS AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF
LIABILITY. THIS LIMITATION WILL APPLY EVEN IF THE OTHER PARTY HAS BEEN ADVISED
OF THE POSSIBILITY OF SUCH DAMAGE; PROVIDED, HOWEVER, THAT THIS LIMITATION WILL
NOT APPLY TO DAMAGES RESULTING FROM ANY BREACH OF THE CONFIDENTIALITY AGREEMENT
OR THE INDEMNIFICATION OBLIGATIONS HEREIN.

 

12.5.2     Active Materials. Under no circumstances will Vetter International or
its Affiliates be responsible for any loss or damage to the Customer Materials,
unless the loss of any Customer Materials occurred through the gross negligence
or willful misconduct of Vetter International or its Affiliates; provided,
however, that in such case Vetter International and its Affiliates’ liability
will not exceed the lesser of: (i) […***…] percent ([…***…] %) of the […***…] of
the respective Product affected by the loss of the Customer Materials or (ii)
[…***…] Euros (€[…***…] ).

 

 

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12.5.3     Recalls. If the Product is recalled or returned as set forth in
Section 7.2 and the recall or return results from the Products’ non-conformity
with the Specifications, the Development Quality Agreement, this Agreement, GMP,
Applicable Laws, or is initiated by a regulatory authority, and such
non-conformity arose due to Vetter International’s or its Affiliates’ gross
negligence, Vetter International’s liability for the recall or returned Product
will not exceed […***…] Euros (€[…***…] ).

 

12.5.4     Maximum Liability. Vetter International and its Affiliates’ liability
to Customer under this Agreement for any reason whatsoever will not exceed: (i)
in the case of any claims of negligence and/or breach of contract, […***…]
percent ([…***…] %) of the contractual amount paid by […***…]; (ii) in the case
of gross negligence and/or breach of contract, […***…] percent ([…***…] %) of
the contractual amount paid by […***…]; or (iii) in the case of indemnification,
[…***…] ([…***…] %) of the contractual amount paid by Customer.

 

12.5.5     No direct Liability of Representatives. Notwithstanding anything to
the contrary contained in this Agreement, it is expressly agreed by and between
the Parties that no Affiliate of Vetter International shall personally assume
any responsibility or liability , but Vetter International shall be responsible
and liable for the performance of any of its Affilites to the same extent as if
Vetter International had performed or failed to perform, all as contemplated or
required hereunder, and any claim made under this Agreement (for clarity,
specifically including the Quality Agreement) shall exclusively be made against
Vetter International.

 

13.

Warranties.

 

13.1.

          NEITHER PARTY MAKES ANY WARRANTY OR CONDITION OF ANY KIND, EITHER
EXPRESSED OR IMPLIED, BY FACT OR LAW, THAT THAN THOSE EXPRESSLY SET FORTH IN
THIS AGREEMENT. VETTER INTERNATIONAL AND ITS AFFILIATES AND CUSTOMER GIVE NO
WARRANTY OR CONDITION OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY WARRANTY OR
CONDITION OF MERCHANTABILITY FOR THE PRODUCTS.

 

14.

Term and Termination.

 

 

14.1.

          Term. This Agreement shall be in full force and effect as of the
Effective Date. This Agreement will expire on the later of (a) ten (10) years
from the Effective Date or (b) the completion of all Services under the last
Statement of Work executed by the Parties prior to the tenth anniversary of the
Effective Date. This Agreement may be extended by mutual agreement of the
Parties or earlier terminated as set forth in this Section 14.

 

 

14.2.

          Termination by Either Party. Either Party may terminate this Agreement
upon prior written notice if the other Party is in major default in the
fulfillment of any obligation under this Agreement and such major default is not
cured within the relevant notice period. The term “major default” shall include,
but not be limited to (i) insolvency, bankruptcy, liquidation, or appointment of
a receiver of any significant part of the property, of a Party or Vetter Pharma;
(ii) in the case of any other default which can be cured, the failure to
commence remedying the default during a period of […***…] calendar days after
the giving of written notice specifying such default; and (iii) with respect to
Customer, the failure to provide for or maintain product liability insurance as
required under this Agreement; or (iv) failure to establish mutual agreement in
accordance with Section 10.5 within […***…] calendar days.

 

 

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14.3.

          Termination by Customer. Customer may immediately terminate this
Agreement at any time with prior written notice to Vetter International if
Customer determines, in its sole discretion and consultation with Vetter
International, that the Product cannot be commercialized for medical,
scientific, regulatory or technical reasons.

 

 

14.4.

          Effect of Termination or Expiration. Upon termination or expiration of
this Agreement, except as stated within this Agreement, neither Party will have
any further obligations under this Agreement, or in the case of termination or
expiration of a Statement of Work, under that Statement of Work, except that:

 

14.4.1.     Customer will purchase, subject to any right of Customer for
late/short delivery and inspection and acceptance, at the agreed prices, any
Product for which purchase orders have been or are required to be placed in
accordance with the applicable Statement of Work prior to the effective date of
termination or expiration.

 

14.4.2.     Customer will be liable to Vetter International for all agreed upon
milestone payments achieved or pro-rated for partial achievement, and the
Parties cooperate to terminate all Services in an orderly manner; provided,
however, that Vetter International will mitigate any non-committed costs as
reasonably possible.

 

14.4.3.     Vetter International will arrange for, at Customer’s option and
expense, to either return any remaining Customer Materials to Customer, to
destroy the Customer Materials, or to deliver the Customer Materials to a third
party, as instructed by Customer.

 

14.4.4.     Vetter International will return to Customer all copies of Customer
Confidential Information and Customer will return to Vetter International all
copies of Vetter International Confidential Information, with the exception of
one copy of such Confidential Information that each Party may retain in a
limited access, secure location to satisfy all regulatory requirements and
compliance with the terms herein.

 

14.5.             Survival. The terms, conditions and obligations under Sections
1, 3, 4, 5, 6, 7, 11, 12, 13, 14.5 and 15 will survive any termination or
expiration.

 

15.

Miscellaneous.

 

 

15.1.

          Independent Contractor. All Services will be rendered by Vetter
International as an independent contractor and this Agreement does not create an
employment relationship, partnership or joint venture between Customer and
Vetter International. Vetter International will not in any way represent itself
to be a partner or joint venturer of or with Customer.

 

 

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15.2.

          Force Majeure. No Party shall be responsible other Party, and no
default shall be deemed to have occurred, for failure or delay in performing any
obligations or for other non-performance if such failure, delay or other
non-performance is caused by or arises from any strike, stoppage of labor,
lockout or any other labor trouble, shortage of energy or raw material or any
inability to obtain any materials or shipping space, breakdown or delays of
carriers or shippers, default or delay by any supplier or sub-contractor or
other events due to internalization of operations and services typically and
customarily provided by a third party, fire, flood, lightning, fog, storm,
unusual weather conditions, explosion, accident, earthquake, volcanic ash,
epidemics, act of God, any public enemy, sabotage, invasion, war (declared or
undeclared), riot, embargo, governmental or administrative act or restraint,
prohibition on import or export of the Product or materials incorporated therein
or parts thereof, (unless arising from a failure to comply with Applicable
Laws), or any matter or cause that is unavoidable by or beyond the reasonable
control of the affected Party (each, an event of “Force Majeure”). A Party shall
be under no obligation to settle a strike, labor stoppage, lockout, or any other
labor trouble by entering into any agreement to settle any thereof and until any
such matter is settled to the satisfaction of the affected Party, such matter
shall continue to be deemed Force Majeure. Any and all of the foregoing shall
also apply to a Party to the extent that an Affiliate of such Party is
performing or providing any service or work in connection with the obligations
of a Party. A Party claiming Force Majeure shall promptly notify the other Party
specifying the cause and probable duration of the failure, delay or other
non-performance. Neither Vetter International nor any of its Affiliates will be
under any obligation to fulfill any purchase order which has been, or should
have been scheduled to be performed during a time period of Force Majeure;
provided, however, a Party so affected shall undertake every reasonable effort
to fulfill its contractual obligations to the extent reasonably possible under
the circumstances. Each Party shall have the right to terminate this Agreement
and/or any SOW under this Agreement if the Force Majeure continues for more than
[…***…] days without further liability for the termination.

 

 

15.3.

          United Nations. The United Nations Convention on Contracts for the
International Sale of Goods shall not apply with respect to the matters set
forth in this Agreement.

 

 

15.4.

          Use of Names. Neither party has the right to use the other party’s
name or the names of the other party’s employees in any advertising, sales
promotional material or press release without prior written permission of the
other party, except to the extent such disclosure is reasonably necessary for
(a) regulatory filings, including filings with the U.S. Securities Exchange
Commission, FDA, or EMA, (b) prosecuting or defending litigation, and
(c) complying with (i) applicable governmental regulations and legal
requirements and (ii) the requirements of any stock exchange or stock listing
entity.

 

 

15.5.

          Notices. All notices required or permitted under this Agreement must
be in writing and must be given by addressing the notice to the address for the
recipient set forth in this Agreement or at such other address as the recipient
may specify in writing under this procedure.

 

If to Customer:                                    Sophiris Bio Corp.

Attn: Allison Hulme, COO and Head of R&D

1258 Prospect Street

La Jolla, California 92037 USA

Fax: […***…]______

 

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If to Vetter International:      Vetter Pharma International GmbH

Attn. Managing Director

Eywiesenstraße 5, 88212 Ravensburg, Germany

Fax: […***…]

 

With copy to:

Vetter Pharma-Fertigung GmbH & Co. KG

Attn. Head of Legal Department

Schützenstraße 87, 88212 Ravensburg, Germany

Fax: […***…]

 

Notices will be deemed to have been given (a) three (3) Business Days after
deposit in the mail with proper postage for first-class registered or certified
mail prepaid, or (b) one (1) Business Day after sending by nationally recognized
overnight delivery service

 

15.6             Assignment. This Agreement may not be assigned or transferred,
in whole or in part, by either party without the prior written consent of the
other party. However, Vetter International may transfer or assign this
Agreement, in whole or in part without the prior written consent of Customer, to
an Affiliate, provided that all obligations of Vetter International are assumed
by the assignee. Notwithstanding the above, Customer may, without prior notice
or consent, assign this Agreement and its rights and obligations hereunder to a
third party in connection with the transfer or sale of all or substantially all
of its business related to the subject matter of this Agreement, or in the event
of a change in control of Customer or its merger, acquisition, consolidation or
a similar transaction, in which event Vetter International has the right to
immediately terminate the Agreement or any Statement of Work based on Vetter’s
commercially reasonable concerns regarding assignee’s ability to meet Customer’s
obligations under this Agreement within a period of ninety days after receipt of
written notification of such sale, merger, consolidation or similar transaction.

 

15.7             Entire Agreement. This Agreement, including the Confidentiality
Agreement attached hereto as Annex 3 and incorporated herein, constitutes the
entire agreement of the parties with regard to its subject matter, and
supersedes all previous written or oral representations, agreements and
understandings between Vetter International and Customer with regard to such
subject matter. In the event of any conflict, discrepancy, or inconsistency
between the terms set forth in the body of this Agreement, any Statement of Work
or any purchase order issued under this Agreement, the terms of the body of this
Agreement will control. Further, the terms of a Statement of Work will control
over the terms of any purchase order issued by Customer for the Services under
that Statement of Work.

 

15.8             Conflict. In the event of any conflict between any provision of
the Development Quality Agreement and the other provisions of this Agreement,
the provisions of the Development Quality Agreement shall control all technical,
pharmaceutical and quality related provisions of the Services, all other
provisions will be controlled by this Agreement. In the event of any conflict
between the Statement of Work and the Agreement, the provisions of the Agreement
shall control.

 

15.9             No Modification. This Agreement may be changed only by a
writing signed by an authorized representative of each Party.

 

 

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15.10

          Severability; Reformation. Any of the provisions of this Agreement
which are determined to be invalid or unenforceable in any jurisdiction will be
ineffective to the extent of such invalidity or unenforceability in such
jurisdiction, without rendering invalid or unenforceable the remaining
provisions hereof and without affecting the validity or enforceability of any of
the other terms of this Agreement in such jurisdiction, or the terms of this
Agreement in any other jurisdiction.  The Parties will substitute for the
invalid or unenforceable provision a valid and enforceable provision that
conforms as nearly as possible with the original intent of the Parties.

 

 

15.11

          Governing Law and Dispute Resolution. The Parties shall attempt to
amicably settle and in good faith resolve any dispute in connection with this
Agreement, by negotiations between designated representatives prior to the
commencement of any litigation. If no amicable settlement and good faith
resolution thereof has been achieved within […***…] Business Days from the
initiation of negotiations, such dispute may be brought by written notice to the
executive management representatives who shall use reasonable endeavors to
amicably settle and in good faith resolve such dispute within […***…] Business
Days of receipt of said notice. If no settlement or resolution is achieved
within the time period, such dispute shall be brought by written notice to the
highest management representatives who shall use reasonable endeavors to
amicably settle and in good faith resolve such dispute within further […***…]
Business Days of receipt of said further notice. If such settlement fails,
either Party may, at its sole discretion, refer any dispute, controversy or
claim arising out of or in connection with this Agreement to Arbitration under
the Rules of Arbitration of the German institution for arbitration (Deutsche
Institution für Schiedsgerichtsbarkeit e.V. (DIS); “Rules”). All disputes,
controversies or claims arising out of or in connection with the present
Agreement shall be finally settled in accordance with the Rules by three
arbitrators appointed in accordance with the Rules. The seat of arbitration
shall be Frankfurt am Main, Germany. The language to be used in the arbitral
proceedings shall be English. Annexes to any procedural document may also be
provided in the German language. This Agreement shall be governed by, construed
and interpreted and all disputes, controversies or claims arising under or in
connection with this Agreement shall be resolved in accordance with the
substantive laws of Germany without recourse to any conflict of laws rules.
Notwithstanding the foregoing, each Party shall be entitled to obtain injunctive
relief against any threatened breach of this Agreement or the continuation of
any such breach by the receiving Party by way of ordinary civil proceedings. Any
decision or arbitral award delivered in the arbitration shall be reasoned and in
writing, and shall be final and binding on the Parties and enforceable in any
competent court of law. The Parties undertake to comply promptly with any award
without delay and shall be deemed to have waived their right to any form of
recourse insofar as such waiver can validly be made.

 

 

15.12

          Waiver. No waiver of any term, provision or condition of this
Agreement in any one or more instances will be deemed to be or construed as a
further or continuing waiver of any other term, provision or condition of this
Agreement. Any such waiver must be evidenced by an instrument in writing
executed by an officer authorized to execute waivers.

 

 

15.13

          Counterparts. This Agreement may be executed in any number of
counterparts, each of which will be deemed an original and all of which together
will constitute one and the same instrument. A facsimile or scanned copy of this
Agreement that includes a party’s signature will be deemed an original.

 

 

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15.14

          Headings. This Agreement contains headings only for convenience and
such headings should not be used in the construction of this Agreement.

 

 

 

 

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IN WITNESS WHEREOF, duly authorized representatives of each Party have executed
this Agreement on the dates and at the places below written.

 

 

SOPHIRIS BIO CORP.

 

 

Signature: /s/ Allison Huhme                     

 

Name: Allison Hulme                                  

 

Title: COO & Head of Research & Development

 

Place: 1258 Prospect Street, La Jolla           

 

Date:6th March 2019                                    

 

 

 

Signature: _______________________________

 

Name:__________________________________

 

Title:___________________________________

 

Place: __________________________________

 

Date:___________________________________

 

 

 

 

VETTER PHARMA INTERNATIONAL GMBH

 

 

Signature: /s/ Hermann Piana                       

 

Name: Dr. Hermann Piana                             

 

Title: Director Key Account Management Europe

 

Place: Ravensburg                                          

 

Date: 19th March 2019                                   

 

 

Signature: /s/ Harmann Kleinle                     

 

Name:Hermann Klienle                                  

 

Title: Key Account Manager                         

 

Place: Ravensburg                                          

 

Date: 19th March 2019                                   

 

 

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ANNEX 1: STATEMENT OF WORK (SAMPLE)

 

Statement of Work No. ___

 

 

This Statement of Work No. ___ (“SOW”), is entered into by and between Vetter
Pharma International GmbH (“VPI”) and Sophiris Bio Corp. (“Sophiris”) and shall
be effective as of _____________ (the “SOW Effective Date”). Upon execution,
this SOW shall be subject to and incorporated into that certain Master Services
Agreement dated ______________________ (the “Agreement”).

NOW, THEREFORE, in reliance upon and in consideration of the following
undertakings and for other good and valuable consideration, the Parties hereby
agree to the following:

 

 

1.

Services. VPI agrees to provide, by VPI itself or via any VPI Affiliate, certain
pharmaceutical development and/or Manufacturing services for Phase I or Phase II
clinical trial projects (“Services”), which Services shall be:

 

 

a.

performed in accordance with the quotation set forth in Annex 1, attached hereto
and incorporated herein by reference;

 

 

b.

subject to the terms and provisions set forth in the Agreement; and

 

 

c.

if expressly agreed that cGMP standards shall apply to such services, subject to
the Development Quality Agreement dated ____________________ (“Quality
Agreement”).

 

 

2.

Pricing. For VPI’s performance of the Services, Sophiris shall pay to VPI the
amounts (“Prices”) set forth in detail in Annex 1, which shall be invoiced and
payable in accordance with the applicable payment schedule set forth therein.
The terms of the Agreement shall apply to the Prices due hereunder.

 

 

3.

Term and Termination. The term of this SOW shall commence as of the SOW
Effective Date and shall continue until completion of the Services described
herein, provided, however, that this SOW may be terminated in accordance with
the Agreement.

 

The terms of the Agreement shall take precedence and control over the terms of
this SOW and those of any purchase order issued by Sophiris in connection with
these Services; further, the terms of this SOW shall take precedence and control
over those of any purchase order issue by Sophiris in connection with these
Services. Any capitalized term used in this SOW but not defined herein shall
have the meaning set forth in the Agreement. A facsimile or scanned copy of this
SOW that includes a Party’s signature shall be deemed an original. This SOW may
be executed in counterparts, each of which is deemed an original, but all of
which together constitute one and the same agreement. Delivery of an executed
counterpart of this SOW electronically or by facsimile shall be effective as
delivery of an original executed counterpart of this SOW.

 

 

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IN WITNESS WHEREOF, the parties by their authorized representatives have
executed this SOW with effect as of the SOW Effective Date:

 

 

 

Sophiris Bio Corp.

 

 

By: ____________________________________

 

Name: __________________________________

 

Title: ___________________________________

 

Date: ___________________________________

 

 

 

 

vetter pharma interNational gmbh

 

 

By: ____________________________________

 

Name: __________________________________

 

Title: ___________________________________

 

Date: ___________________________________

 

 

 

By: ____________________________________

 

Name: __________________________________

 

Title: ___________________________________

 

Date: ___________________________________

 

 

 

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Annex 1 to the Statement of Work No. [#]

 

 

Quotation titled:

“ _____________________ ”

 

Quotation No: ________

 

Dated: ____________________

 

 

 

[see following pages]

 

 

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ANNEX 2: DEVELOPMENT QUALITY AGREEMENT

 

 

 

[…***…]

 

 

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ANNEX 3: CONFIDENTIALITY AGREEMENT

 

 

 

[…***…]

 

 

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