Exhibit 10.15

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

CONTRACT MANUFACTURING AGREEMENT

 

This Contract Manufacturing Agreement (“Agreement”) is entered into and made
effective as of the 29th day of August, 2012 (“Effective Date”) by and between
Onyx Pharmaceuticals International GmbH, a wholly-owned subsidiary of Onyx
Pharmaceuticals, Inc. (“Onyx”), and Senn Chemicals AG, a Swiss corporation
(referred to herein as “SENN”). Onyx and SENN are each sometimes referred to
herein individually as a “Party” and collectively as the “Parties”. Capitalized
terms not otherwise defined herein shall have their respective meanings as
defined in this Agreement.

 

WHEREAS, Onyx is in the business of discovering, developing and
commercializating pharmaceutical products including the Pharmaceutical
Product(s) (as defined below);

 

WHEREAS, SENN is in the business of providing pharmaceutical development and
manufacturing services;

 

WHEREAS, the Parties have entered into that certain MSA (as defined below),
pursuant to which SENN has provided services relating to development, scale-up,
manfacture and supply of the Product(s) (as defined below) to Onyx;

 

WHEREAS, the Parties now wish to enter into this Agreement, pursuant to which
SENN shall manufacture and supply the Product(s) at commercial scale under the
direction and oversight of Onyx and sell such Product(s) to Onyx, and Onyx shall
purchase such Product(s) from SENN, all on the terms and conditions set forth in
this Agreement.

 

NOW, THEREFORE, in consideration of the mutual promises contained herein, the
Parties agree as follows:

 

1.0          DEFINITIONS

 

In addition to the terms defined elsewhere in this Agreement, the following
terms shall have the following meanings, provided that terms defined in the
singular shall have the same meaning when used in the plural, and vice versa,
unless stated otherwise.

 

1.1          “Affiliate” of any Party means any corporation, firm, limited
liability company, partnership or other entity which directly or indirectly
controls or is controlled by or is under common control with any Party to this
Agreement. For purposes hereof, “control” means (a) in the case of a corporate
entity, ownership, directly or indirectly through one or more Affiliates, of
fifty percent (50%) or more of the shares of stock entitled to vote for the
election of directors, and (b) in the case of a non-corporate entity, ownership,
directly or indirectly through one or more Affiliates, of fifty percent (50%) or
more of the equity interests with the power to direct the management and
policies of such non-corporate entity.

 

1.2          “Agreement” means this Contract Manufacturing Agreement, including
any exhibits, schedules, statements of work or other attachments hereto, as the
same may be validly amended by the Parties from time to time.

 

1

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1.3          “Agreement Technology” means any invention, whether patentable or
unpatentable, discovery, know-how, process, procedure, method, protocol,
formula, technique, software, design, drawing, data, materials or other
technical information arising from performance by SENN or any of it
subcontractors (if any) under this Agreement, and shall include any and all of
the foregoing that relates to the Product(s) or the Pharmaceutical
Product(s) and/or their respective methods of synthesis, preparation, processes,
purification, formulation, analysis, development and/or methods of bulk
manufacture that is developed by either or both Parties under this Agreement.
For the avoidance of doubt, Agreement Technology includes Work Product, but does
not include any Background Technology.

 

1.4          “Agreement Technology Patent Rights” means any patent, patent
application and/or worldwide letters patent relating to Agreement Technology,
including any division, continuation, continuation-in-part, provisional, reissue
or reexamination, or extension thereof, or substitute application therefore.

 

1.5          “Approval Application” means any new drug application filed with
the FDA seeking approval to sell any Pharmaceutical Product(s) in the United
States, or any marketing approval application filed with EMA seeking approval to
sell any Pharmaceutical Product(s) within the EU, or any other application filed
with any other Regulatory Authority seeking approval to sell any Pharmaceutical
Product(s) in any other jurisdiction, or any successor application(s) thereto.

 

1.6          “Background Technology” means any invention, whether patentable or
unpatentable, discovery, know-how, process, procedure, method, protocol,
formula, technique, software, design, drawing, data, materials or other
technical information (a) that is in existence as of the Effective Date or
(b) that arises after the Effective Date but (i) is not Work Product or other
Agreement Technology and (ii) is generated or derived by SENN or any of its
subcontractors (if any) in the course of performing this Agreement and has
general application to manufacturing processes or formulation development for
drug products or drug delivery systems.

 

1.7          “Background Technology Patent Rights” means any patent, patent
application and/or worldwide letters patent relating to Background Technology,
including any division, continuation, continuation-in-part, provisional, reissue
or reexamination, or extension thereof, or substitute application therefore.

 

1.8          “Calendar Quarter” means each calendar quarter during the Term of
this Agreement, beginning on January 1, April 1, July 1 or October 1 during the
Term, as the case may be, with the first Calendar Quarter commencing on
January 1, 2013.

 

1.9          “Calendar Year” means each twelve (12) month period during the Term
of this Agreement, commencing with the first January 1st following the Effective
Date, and each January 1st thereafter during the Term, provided that Calendar
year 2012 shall include the period from the Effective Date through December 31,
2011.

 

1.10        “Certificate of Anaylsis” or “C of A” means a written document from
SENN listing the items tested, Specifications and test resutls and certifying
that the specific lot or batch of Product(s) listed therein conforms to the
Specifications.

 

1.11        “Certificate of Compliance” or “C of C” means a written document
from SENN certifying that the specific lot or batch of Product(s) listed therein
has been manufactured in accordance with all of the provisions of Section 7.2 of
this Agreement and consistent with the batch record and analytically tested in
compliance with all cGMPs.

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

2

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1.12        “cGMPs” or “cGMP Requirements” means those practices in the
manufacture of pharmaceutical products that are recognized as the current good
manufacturing practices, including, without limitation, each of the following as
in effect on the Effective Date of this Agreement and as amended or revised from
time to time thereafter: (a) the FDA Act, including 21 C.F.R. parts 11, 210 and
211, and other FDA regulations, policies and guidelines governing the
manufacturing, testing, storage and/or quality control of active pharmaceutical
ingredients for use in human drug pharmaceutical products; and (a) all ICH
guidance documents as appropriate, including EU Directives 2003/94IEC code of
GMP and 2001/83IEC as amended by 2004/27/EC code of practice for the QP, and ICH
Tripartite Guidance Q7A entitled “ICH Good Manufacturing Practice Guidance for
Active Pharmaceutical Ingredients”, as applied to active pharmaceutical
ingredients for use in human drug pharmaceutical products.

 

1.13        “Change Order” has the meaning set forth in Section 3.3 (c).

 

1.14        “CMC” means any chemistry manufacturing and control information
required by any Regulatory Authority for the filing of any IND or any Approval
Application.

 

1.15        “Confidential Information” means, subject to Section 9.2 and the
other terms and conditions of this Agreement, all information, in any form or
format (including tangible, oral or electronic), (a) provided by either Party or
its Affiliates hereunder to the other Party pursuant to this Agreement, or
(b) generated by SENN or any of its subcontractors (if any) in the performance
of this Agreement (including all Work Product), and/or (c) or which a Party
becomes aware as part of the activities contemplated pursuant to this Agreement,
including but not limited to: any information about manufacturing,
testing/analysis methods or processes; any Product(s) or other raw materials,
starting materials or intermediates; any Pharmaceutical Product(s) or other
pharmaceutical products (investigational or not); any samples, specimens and
other materials or compounds or retention samples; analyses and the result of
such analyses; information on research and development compounds; technical
know-how; formulas; studies; regulatory submissions (including any INDs and any
Approval Applications); regulatory records; research data and information;
financial information; sales and marketing information (including services
proposals, price quotations and customer lists); inventions; patent applications
and other trade secrets; information relating to potential new transactions and
business between the Parties; and all information developed or prepared by
either Party pursuant to this Agreement.

 

1.16        “Cure Period” has the meaning set forth in Section 10.3.

 

1.17        “Debarment Act” means the Generic Drug Enforcement Act of 1992, and
the regulations promulgated thereunder, each as amended from time to time.

 

1.18        “Effective Date” has the meaning set forth in the introductory
paragraph of this Agreement.

 

1.19        “EMA” means the European Medicines Agency, or any successor agency
thereto.

 

1.20        “EU” means the European Union or any successor thereto, and includes
all countries and jurisdictions as may be added to the European Union from time
to time during the Term.

 

1.21        “FDA” means the United States Food and Drug Administration, or any
successor agency thereto.

 

1.22        “FDA Act” means the Food, Drug and Cosmetic Act, and the regulations
promulgated thereunder, each as amended from time to time.

 

1.23        “Force Majeure” has the meaning set forth in Section 12.5.

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

3

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

 

1.24        “GAAP” means United States generally accepted accounting principles
consistently applied by a Party.

 

1.25        “Governmental Authority” means any federal, national, state,
provincial or local government, or political subdivision thereof, or any
multinational organization or any authority, agency or commission entitled to
exercise any administrative, executive, judicial, legislative, police,
regulatory or taxing authority or power, any court or tribunal (or any
department, bureau or division thereof, or any governmental arbitrator or
arbitral body).

 

1.26        “IMPD” means any investigational medicinal product dossier filed
with the EU pursuant to EudraLex, Volume 10, Chapter I to begin clinical studies
of any Pharmaceutical Product(s) in humans, or any successor
application(s) thereto.

 

1.27        “IND” means any investigational new drug application filed with the
FDA pursuant to 21 C.F.R. 312 et seq. (or similar application filed with another
Regulatory Authority outside the United States) to begin clinical studies of any
Pharmaceutical Product(s) in humans, or any successor application(s) thereto.

 

1.28        “Indemnitee” and “Indemnitor” have the meanings set forth in
Section 11.4.

 

1.29        “Law” means a federal, state or local or foreign or multinational
law, statute, standard, ordinance, code, rule, regulation, resolution or
promulgation, or any government order, or any license, franchise, permit or
similar right granted under any of the foregoing, or any similar provision
having the force or effect of law.

 

1.30        “Manufacture and Release Requirements” means all methodologies,
analytical tests, process parameteres and cGMP requirements necessary to
manufacture and release Product(s) to Onyx in conformity with the
Specifications. All Manufacture and Release Requirements not included as
exhibits to this Agreement shall be as set forth in the Quality Agreement.

 

1.31        “Master Batch Record” has the meaning set forth in Section 2.1(a).

 

1.32        “MSA” means that certain Master Services Agreement, dated as of
June 1, 2007, entered into by the Parties, including all statements of work and
other attachments thereto, as may be validly amended by the Parties from time to
time.

 

1.33        “Order” has the meaning set forth in Section 3.2.

 

1.34        “Onyx” has the meaning set forth in the introductory paragraph of
this Agreement.

 

1.35        “Onyx Forecast” has the meaning set forth in Section 3.1.

 

1.36        “Onyx Materials” means any and all raw materials, in-process
materials or other materials that are supplied or purchased by Onyx and provided
to SENN, or for which SENN was reimbursed by Onyx, in connection with this
Agreement, and includes, without limitation, the Onyx Materials listed on
Exhibit C attached hereto and incorporated into this Agreement, as such
Exhibit C may be validly modified by the Parties from time to time during the
Term upon mutual written agreement.

 

1.37        “Onyx Equipment” means any and all equipment supplied or purchased
by Onyx and provided to SENN, or for which SENN was reimbursed by Onyx, in
connection with this Agreement, and includes,

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

4

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

 

without limitation, the Onyx Equipment listed on Exhibit C, as such Exhibit C
may be validly modified by the Parties from time to time during the Term upon
mutual written agreement.

 

1.38        “PAI” means any pre-approval inspection by any Governmental
Authority relating to the Product(s) or the Pharmaceutical Product(s).

 

1.39        “Party” means either Onyx or SENN, and “Parties” means Onyx and
SENN.

 

1.40        “Pharmaceutical Product(s)” means any and all pharmaceutical
products for human use, in any delivery method, dosage form or formulation,
containing carfilzomib as an active pharmaceutical ingredient, whether as a sole
active pharmaceutical ingredient or in combination with any other active
pharmaceutical ingredient or ingredients.

 

1.41        “Price” means the price to be paid by Onyx to SENN for each Product
as set forth in Exhibit B attached hereto and incorporated into this Agreement,
as such Exhibit B may be validly modified by the Parties from time to time
during the Term upon mutual written agreement..

 

1.42        “Prime Rate” has the meaning set forth in Section 6.3.

 

1.43        “Product(s)” means, collectively, those products and materials set
forth in Exhibit A attached hereto and incorporate into this Agreement,
including the applicable Specifications set forth in Exhibit A, as such
Exhibit A may be validly modified by the Parties from time to time during the
Term upon mutual written agreement.

 

1.44        “Quality Agreement” means that certain Master Quality Agreement
entered into by Onyx Pharmaceuticals, Inc. and SENN CHEMICALS AG effective on
May 9, 2011, that sets forth the regulatory and compliance roles and
responsibilities of both Parties, applicable to any Order for any Product
sourced or manufactured by SENN pursuant to this Agreement. This Agreement
incorporates by reference all of the terms and conditions of the Quality
Agreement and such Quality Agreement is made a part hereof as though fully set
forth herein. In the event the Quality Agreement contains provisions which are
not inconsistent with, but are in addition to, the terms set forth in this
Agreement, the Quality Agreement shall be supplemental to the terms and
conditions set forth in this Agreement. Notwithstanding the foregoing or
anything in this Agreement or the Quality Agreement to the contrary, however, in
the event of any conflict or inconsistency between the provisions of this
Agreement and the provisions of the Quality Agreement, the provisions of this
Agreement shall govern, except for matters pertaining to the quality of the
Product(s) or Pharmaceutical Product(s), as to which the provisions of the
Quality Agreement shall govern.

 

1.45        “Regulatory Authority” means any federal, national, multinational,
state, provincial or local regulatory agency, department, bureau or other
Governmental Authority with authority over the marketing and sale of a
pharmaceutical product in any country in the Territory, including without
limitation, the FDA in the United States and the EMA in the EU.

 

1.46        “Release” means SENN’s formal approval indicating suitability of the
Product(s) as evidenced by a Certificate of Analysis and a Certificate of
Compliance provided by SENN to Onyx, all as provided under this Agreement and
the Quality Agreement.

 

1.47        “Release Documentation” has the meaning set forth in Section 4.3.

 

1.48        “SENN” has the meaning set forth in the introductory paragraph of
this Agreement.

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

5

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

 

1.49        “SENN Facility” means the SENN facility located at Dielsdorf,
Switzerland, and/or such other SENN facility as Onyx may approve for purposes of
this Agreement in advance and in writing.

 

1.50        “Specifications” means the specifications for each Product to be
sourced or manufactured by SENN for Onyx pursuant to this Agreement as set forth
on Exhibit A attached hereto and hereby incorporated into this Agreement, as
such Specifications may be validly amended by the Parties from time to time
during the Term upon mutual written agreement.

 

1.51        “Term” has the meaning set forth in Section 10.1.

 

1.52        “Territory” means the world.

 

1.53        “Third Party” shall mean any party other than Onyx or SENN or any
Affiliate of a Party.

 

1.54        “Third Party Technology” means any invention, discovery, technology,
know-how and/or other intellectual property that is not Agreement Technology or
Background Technology.

 

1.55        “Work Product” means all results of performance by SENN or any of
its subcontractors (if any) under this Agreement, including but not limited to
the Product(s) (or any work-in-progress, derivatives or other compounds provided
under this Agreement), and all data, results, information, documentation
resulting from performance by SENN or its subcontractors (if any) under this
Agreement, including but not limited to reports, batch records (including the
Master Batch Record), C of As, C of Cs, all other Release Documentation,
laboratory notebooks and any other deliverables of SENN under this Agreement.
For the avoidance of doubt, Work Product is Confidential Information and
property of Onyx for purposes of this Agreement, provided that SENN retains
ownership of the underlying records.

 

2.0          PURPOSE

 

SENN agrees to manufacture, under the direction and oversight of Onyx and sell
the Product(s) to Onyx, and Onyx agrees to purchase and receive such
Product(s) from SENN, pursuant to the terms and conditions of this Agreement
(including each Order, as defined below), including as set forth in this
Article 2.0.

 

2.1          SENN Manufacture and Supply. During the Term of this Agreement,
SENN shall:

 

(a)                                 prepare the Product(s) in compliance with
(i) all applicable Laws including cGMP Requirements, (ii) a detailed protocol
which shall be reviewed and approved by Onyx in writing prior to SENN initiating
such preparation (the “Master Batch Record”), (iii) the covenants,
representations and warranties of SENN hereunder, (iv) the Specifications for
such Product(s), (v) the terms and conditions of this Agreement, and (vi) the
terms and conditions of the Quality Agreement; and

 

(b)                                 deliver the Product(s) to Onyx or a third
party designated by Onyx in writing in accordance with the applicable Order and
the other terms and conditions of this Agreement.

 

2.2          Additional SENN Responsibilities. In connection with such
manufacture and supply as provided in Section 2.1, SENN’s responsibilities
pursuant to this Agreement include the following (without limitation), all to be
performed in accordance with the terms and conditions of this Agreement
(including any applicable Order):

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

6

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

 

(a)                                 unloading, handling and storing raw
materials, any Onyx Materials, all materials provided by SENN, and process
products and all packaging materials at the SENN Facility, and proper use,
operation, maintenance and storage of any Onyx Equipment;

 

(b)                                 employing its existing manufacturing
processes and logistics, adopting Onyx’s manufacturing processes and logistics,
or establishing new production methods and logistics, in each case approved by
Onyx, as the Parties may agree will enable SENN to manufacture and sell the
Product(s) to Onyx;

 

(c)                                  collecting and retaining samples of the
Product(s) as provided in the Quality Agreement;

 

(d)                                 conducting on-going stability testing of the
Product(s) and of raw materials and process products as provided in the Quality
Agreement;

 

(e)                                  packaging the Product(s);

 

(f)                                   safe handling and secure storing of the
bulk and packaged Product(s) at the SENN Facility after the transfer of title of
ownership of such Product(s) to Onyx;

 

(g)                                  preparing the Product(s) for shipment;

 

(h)                                 making the Product(s) available to a common
carrier;

 

(i)                                     cooperating with Onyx as requested by
Onyx from time to time in the preparation and submission of CMC information for
any IND and for any Approval Application;

 

(j)                                    cooperating with Onyx in the preparation
for any PAI as provided in the Quality Agreement or otherwise agreed to in
writing by the Parties;

 

(k)                                 keeping records and reporting to Onyx and to
applicable Governmental Authorities as required by this Agreement, the Quality
Agreement and/or applicable Law; and

 

(1)                                 handling, storing, treating and disposing of
wastes generated by SENN in conection with SENN’S performance under this
Agreement as required by applicable Law.

 

2.3        Facilities, Materials and Equipment. SENN shall be responsible for
the procurement, proper quality and documentation of the quality of all
materials, equipment and facilities (including the SENN Facility) used in
connection with SENN’s performance under this Agreement, except for any Onyx
Materials and Onyx Equipment provided by Onyx pursuant to this Agreement or as
otherwise expressly agreed to in writing by the Parties. At the option of Onyx,
Onyx may require SENN to purchase, in its own name and on its own behalf, from
Onyx, Affiliates, or Third Parties that have been pre-approved by Onyx as a
vendor any ingredients, materials, components, or consumables necessary to
manufacture the Product(s) ordered by Onyx hereunder.

 

2.4        Subcontracting. With Onyx’s prior written consent, SENN may
subcontract the performance of certain of its obligations under this Agreement
to qualified third parties; provided that (a) SENN notifies Onyx of the proposed
subcontractor and identifies the specific services proposed to be performed by
such subcontractor, (b) Onyx agrees in advance and in writing to the use of such
subcontractor, and (c) such subcontractor performs all services in compliance
with the terms and conditions of this Agreement (including, without limitation,
Section 2.1). SENN shall remain liable to Onyx for the performance of any

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

7

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

 

such subcontractor. For the avoidance of doubt, Third Parties from which SENN
procures commercially-available raw materials (including solvents and reagents)
are not subcontractors.

 

2.5        Onyx Responsibilities. In connection with such manufacture and supply
as provided in Section 2.1, Onyx’s responsibilities pursuant to this Agreement
include the following (without limitation), all to be performed in accordance
with the terms and conditions of this Agreement (including any applicable
Order):

 

(a)                                 transferring any necessary Background
Technology (to the extent not already transferred pursuant to the MSA) to SENN;

 

(b)                                 providing supply and operations planning
including forecasts and orders as provided in Section 3.0;

 

(c)                                  providing on-site support in connection
with Product(s) as set forth in the Quality Agreement or as otherwise agreed
upon by the Parties in writing from time to time;

 

(d)                                 completing any and all regulatory reports or
filings and obtaining any and all approvals required of the sponsor of the
Pharmaceutical Product in all appropriate jurisdictions; and

 

(e)                                  providing advance review copies of any CMC
information to be included in any IND, IMPD or the equivalent for any Approval
Application.

 

2.6          Onyx Materials and Onyx Equipment. With regard to any Onyx
Materials and Onyx Equipment provided by Onyx to SENN pursuant to this
Agreement, Onyx shall provide SENN with all data and information as may be
necessary to apprise SENN of the stability, proper storage, use, maintenance,
safety and other characteristics and requirements of such Onyx Materials and
Onyx Equipment as applicable, prior to their delivery to SENN, and Onyx shall
supply any such Onyx Materials and Onyx Equipment in a manner that complies with
applicable Law (including any permits necessary to ship such Onyx Materials and
Onyx Equipment). SENN shall utilize Onyx Materials and Onyx Equipment solely for
purposes of manufacturing pursuant to this Agreement, and shall use all such
Onyx Materials and Onyx Equipment strictly in accordance with the terms and
conditions of this Agreement (including compliance with cGMP Requirements). SENN
shall not transfer any Onyx Materials and Onyx Equipment to any Third Party
except pursuant to permitted subcontracting pursuant to Section 2.4 or with
Onyx’s prior written consent in its sole discretion. SENN shall clearly mark all
relevant containers or boxes containing the Onyx Materials as being owned by
Onyx. Further, at Onyx’s request, SENN shall account to Onyx for all Onyx
Materials and Onyx Equipment provided to SENN hereunder. SENN shall be
responsible for replacing any Onyx Materials and Onyx Equipment, at SENN’s cost,
in the event of any storage, use or transfer of any Onyx Materials or Onyx
Equipment that does not comply with the terms and conditions of this Agreement
or that damages any Onyx Materials or Onyx Equipment. All Onyx Materials and
Onyx Equipment shall be and remain the property of Onyx.

 

3.0          FORECASTING, ORDERING AND CAPACITY

 

3.1          Forecasts; Firm Purchase Order Requirement. Commencing on
January 1, 2013, in order to facilitate production planning by the Parties
before the start of each Calendar Quarter during the Term, Onyx shall deliver to
SENN a written, rolling four (4)-Calendar Quarter forecast of the amount(s) of
each of the Product(s) that Onyx is requesting SENN to manufacture (or
requesting SENN to source, in the case of specified raw materials or starting
materials within the scope of Products, as defined in Section 1.40 of this
Agreement), for SENN to manufacture under this Agreement during the next four
(4) Calendar Quarters (collectively, the “Onyx Forecast”). On a rolling [*]
basis, this Onyx Forecast shall

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

8

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

 

become a firm, committed Order, meaning that Onyx shall be required to purchase
from SENN [*] of the forecasted amount(s) of each of the Product(s) set forth in
the [*] of each such Onyx Forecast delivered hereunder (e.g., [*] period).

 

3.2          Orders. Together with each Onyx Forecast delivered by Onyx to SENN
under Section 3.1, Onyx shall provide SENN with one (1) or more firm purchase
orders (each, including the additional information set forth below, an “Order”
and collectively, “Orders”), unless such Orders shall have been previously
provided by Onyx to SENN, such that the Orders submitted with the current Onyx
Forecast, combined with all previously submitted Orders, shall constitute an
aggregate firm purchase order for the amount of Product(s) set forth in the [*]
of the accompanying current Onyx Forecast, in order to satisfy the firm purchase
order requirement under Section 3.1. Each Order shall specify the quantity(ies)
of Product(s) to be manufactured, the price (consistent with the terms of this
Agreement), schedule of payment, date(s) of Release and delivery by SENN and
other relevant matters. Each such Order that is applicable to and consistent
with the firm purchase order requirement under Section 3.1 shall, upon issuance
by Onyx, automatically be deemed to be accepted by SENN, and shall be
incorporated into and made a part of this Agreement without any further action
by the Parties.

 

3.3          Excess Quantities; Additional Orders; Modifications to Orders;
Complications; Coordination.

 

(a)                                 In the event quantities of the
Product(s) are prepared by SENN in excess of the quantities specified in an
Order, SENN shall immediately notify Onyx in writing of the existence and
quantity of such extra Product(s) and Onyx shall have the right (but not the
obligation) to purchase such excess quantities of the Product(s), in whole or in
part, on the terms (including the applicable price) set forth in this Agreement,
provided that SENN shall destroy any and all remaining quantities of the
Product(s) in excess of that extra amount (if any) delivered to Onyx hereunder.

 

(b)                                 Onyx may elect (but shall not be obligated
to) submit to SENN one (1) or more additional Orders for Product(s) from time to
time during the Term of this Agreement, that are in addition to the
then-applicable firm purchase order requirement under Section 3.1 as ordered
pursuant to Section 3.2. Each such additional Order, if any, shall specify the
information provided in Section 3.2 including the applicable Product(s) and
pricing (consistent with the terms of this Agreement), and the date(s) by which
Onyx requested such extra Order(s) to be Released and delivered by SENN. Within
[*] after the date of SENN’s receipt of any such Order hereunder, SENN shall
notify Onyx in writing whether or not SENN accepts or rejects such additional
Order in whole or in part ([*]). SENN shall use all commercially reasonable
efforts to supply all amounts of Product(s) ordered by Onyx under this
Section 3.3(b) on a timely basis. Onyx shall be entitled to cancel any such
additional Order hereunder, on written notice to SENN, provided that at the time
of such cancellation SENN has not commenced manufacture pursuant to such Order.

 

(c)                                  During the Term of this Agreement, Onyx may
from time to time request to modify one (1) or more Orders in writing, provided
that such changes are mutually agreed upon in writing by the Parties. Such
modification request shall be submitted in writing (a “Change Order”) pertaining
to any existing Order subject to the terms and conditions set forth in this
Section. If Onyx requests a Change Order, SENN has the right to (i) revise
previously quoted pricing for any such modified Order to which the Change Order
pertains; (ii) revise the project to reflect the modification contained in the
Change Order including without limitation delivery dates and deliverables;
(iii) modify specifications and undocumented requirements where needed;
(iv) conduct needed out of specification

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

9

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investigations associated with stability programs; (v) change raw material
pricing as necessary; and (vi) identify any unforeseen difficulty in executing
the project and provide estimated increased costs due to such difficulties. Any
of the revisions or modifications listed in subsections (i) through (vi) of this
Section 3.3 (c) are to be mutually agreed upon prior to the Parties executing
any such Change Order.

 

(d)                                 Material rework to Product or generation of
additional Product will require a revision to quoted pricing under the following
conditions: (a) where the Product does not conform to the approved specification
that was produced in accordance with Onyx pre-approved process, and where
applicable, Onyx authorized deviations to the process; (b) for Product that
conformed to Onyx approved specifications that was later determined not to have
adequate stability; and (c) where lower than expected Product yield is
determined not to be the result of operator error, machine error or breach of
manufacturing environmental conditions on the part of SENN.

 

(e)                                  If any Order is placed on-hold by Onyx
after SENN initiates activities associated with the deliverables that are part
of such Order, Onyx may either (i) pay a monthly stand-by fee (“Stand-By Fee”)
to SENN or (ii) authorize SENN to re-deploy those resources dedicated to the
Order. To place an Order on hold, Onyx must submit a Change Order request to
SENN. In the Change Order, Onyx will request either that SENN place the Order on
hold and set forth an estimated hold time or authorize SENN to re-deploy
resources. The Stand-By Fee shall be calculated by SENN based on the Change
Order request. SENN shall advise Onyx of the Stand-By Fee as soon as reasonably
practicable after receiving the Change Order request relating to placing the
Order on hold. If Onyx does not choose the stand-by option and releases
resources, SENN will resume the Order as soon as commercially reasonable upon
receipt of Onyx’s written request to resume the Order.

 

(f)                                   In the unlikely event that at any time
during the manufacturing process there is a Product failure where SENN has
followed all protocols and instructions from Onyx and such failure is not the
result of any action or inaction by SENN, Onyx shall be responsible for and
shall reimburse SENN for all costs associated with the reprocessing or
remanufacture of such Product. Such reimbursement shall be paid to SENN in
accordance with the invoicing procedure set forth in this Agreement.

 

(g)                                  SENN will periodically consult with Onyx at
mutually acceptable, prearranged times to keep Onyx fully informed of the
progress of all Orders pursuant to this Agreement. SENN shall consult with Onyx
regarding all methods, reagents, protocols and the like and Onyx shall have
final approval authority over all aspects of all Orders.

 

3.4          Planning and Coordination. The Parties recognize that detailed and
continuing exchanges of information are needed to optimize the administration of
this Agreement. To that end, each Party shall notify the other Party in writing
of the individual representative of such Party responsible for exchanging
information and resolving issues that may arise under this Agreement (including,
without limitation, managing manufacturing costs or capacities, managing the
risk of loss, cost reduction or efficiency initiatives associated with the
manufacturing process, demand planning, production scheduling, or hedging raw
material costs). The designated representatives (and additional personnel as
desired) of each Party shall conduct a planning meeting at least once per
Calendar Year during the Term intended to address any and all issues that may
arise under this Agreement. In addition, the Parties agree that:

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

10

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

 

 

(a)                                 Starting no later than six (6) months after
the Effective Date on a date that is mutually acceptable to the Parties, and
continuing annually thereafter during the Term of this Agreement on the
anniversary of such date (or other date mutually acceptable to the Parties),
unless waived by the Parties, the Parties shall hold an annual meeting, either
in person or by telephone. The agenda for such meeting may include a review of
the manufacture and reports and records for the preceding twelve (12)-month
period and discussions and decision-making (in accordance with the terms and
conditions of this Agreement) regarding implementation of any proposed changes,
if any.

 

(b)                                 SENN shall provide Onyx with information
reasonably required to satisfy Onyx’s financial reporting requirements under
GAAP, as well as all information reasonably required for Onyx to satisfy
applicable Law (including, without limitation, internal control testing and
other requirements under the Sarbanes-Oxley Act, as well as any applicable
provisions of the California Transparency in Supply Chains Act of 2010),
including by providing the monthly inventory and transaction summaries provided
in Section 3.4(c). Onyx and/or its designee(s) shall be entitled to audit SENN
as to all such information reasonable required to satisfy Onyx’s requirements
under applicable Law or in connection with Onyx’s financial reporting
requirements under GAAP.

 

(c)                                  The Parties will identify and implement
appropriate communication tools under their respective information management
systems such that SENN shall provide Onyx with appropriate inventory and
transaction information on a monthly basis, including an adequate inventory of
Product(s) inventory (including work-in-progress, completed but not yet
Released, and Released Product(s) that is not yet shipped) as well as an
Product(s) shipment transaction summary from the previous month.

 

3.5          Annual Campaigns. SENN may elect to perform one (1) or more
campaigns under this Agreement on an annual basis to supply Product(s) to Onyx
in accordance with this Agreement, provided that Onyx agrees in advance in
writing and that the Parties cooperate in the planning of such campaign(s) such
that Onyx can maintain inventory of Released Product(s) that has reasonable
stability shelf-life in its chain of manufacture and supply of the
Pharmaceutical Product for the commercial market and other uses, as determined
by Onyx in its sole discretion.

 

4.0          RELEASE, DELIVERY AND STORAGE

 

4.1          Shipment. Onyx (or its designee) will provide written instructions
to SENN for shipment and method(s) of shipment of all Product(s), in the Order
or otherwise. SENN shall use all commercially reasonable best efforts to deliver
to Onyx (or third party designated by Onyx in writing) the Product(s)s for each
Order under Section 3.2 as specified by Onyx (or its designee) by the delivery
date specified in the Order utilizing the specified shipment method(s). All
Product(s) generated hereunder shall be packaged and delivered to Onyx Free
Carrier Dielsdorf, Switzerland (FCA Dielsdorf, Incoterms 2010). Delays solely
caused by matters under the control of Onyx or by a Force Majeure Event shall
extend SENN’s deadlines by a period equal to the length of such delay. Emergency
response for any incident during transit shall be the responsibility of Onyx.

 

4.2          Release and Other Documentation by SENN. Along with each amount of
Product(s) delivered hereunder to Onyx (or a third party designated by Onyx in
writing), SENN shall present to Onyx each of the following (collectively, the
“Release Documentation”): , batch identification, Certificate of Analysis and
Certificate of Compliance for the Product(s), a copy of the corresponding batch
records and analytical data agreed to by the Parties in writing, and any other
information required by the applicable agreed-upon

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

11

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

 

Order or by the Quality Agreement. The Parties shall confer prior to any such
delivery of Product(s) regarding the container and shipping details, the
analytical results and other related data and information and any other details
relating to the Release Documentation or other pertinent details. Onyx may audit
and make copies of any such Release Documentation, and any underlying data or
information, during SENN’s normal business hours for purposes of due diligence
and verification of compliance with cGMP Requirements, the Specifications, this
Agreement, the Quality Agreement, the applicable Order and all applicable Laws.

 

4.3          Packaging. All Product(s) shall be shipped by SENN in mutually
agreed upon types and sizes of packaging or other shipping containers. Onyx (or
its designee) shall provide reasonable written specifications for packaging
materials for all Product(s).

 

4.4          Title and Risk of Loss of Product(s). Title to Product(s) that has
been manufactured hereunder shall pass to Onyx on the manufacturing date.
Notwithstanding the foregoing, Onyx shall have the ability to accept or reject
Released Product in accordance with Article 5.0 below. . Risk of loss or damage
for such Product(s) shall pass from SENN to Onyx upon SENN’s delivery of the
Product(s) to a common carrier at the shipment point, or if applicable at the
time SENN begins to warehouse the Released Product(s) for Onyx upon Onyx’s
written request (and pricing terms mutually acceptable to the Parties for such
storage, if any). Title and risk of loss to such Product(s) shall remain with
SENN until the Product(s) have been shipped to Onyx; sales terms are [*].

 

4.5          Storage of Product(s). Upon Onyx’s written request, SENN shall
store the Released Product(s) for Onyx. SENN shall clearly mark all relevant
containers or boxes containing the Product(s) as being owned by Onyx. Title to
the Released Product(s) stored by SENN shall remain with Onyx.

 

5.0          ACCEPTANCE OR REJECTION OF PRODUCTS

 

5.1          Evaluation Period for Released Product(s). Upon receipt of any and
all Product(s) Released by SENN in accordance with Section 4.3 and delivered in
accordance with the terms of this Agreement, Onyx will have [*] from the date
any such Released and delivered Product(s) is/are delivered to its designated
destination to evaluate such Product(s) and to reject, in whole or in part, such
Product(s); provided that, Onyx may reject any Product(s) only if (a) SENN fails
to deliver the Release Documentation or such Release Documentation does not
comply with the terms and conditions of this Agreement; (b) the Product(s) were
not processed according to the Release Documentation (including cGMP
Requirements); or (c) the Product(s) do not meet the Specifications or do not
comply with any of SENN’s other representations, warranties or covenants to Onyx
under Section 7.2. Any such rejection of the Product(s) will be given by written
notice from Onyx to SENN specifying the basis for Onyx’s rejection. In the event
that SENN failed to meet the “best effort criteria” set out in Article 7.0
below, SENN shall use all commercially reasonable best efforts to bring the
rejected Product(s) and applicable Release Documentation into full conformity
with the terms and conditions of this Agreement, and Onyx shall have the right
to withhold payment for the applicable Product(s) until SENN delivers to Onyx
Product(s) and Release Documentation that are fully compliant with the terms and
conditions of this Agreement. The covenants and warranties given by SENN
hereunder shall survive any failure to reject by Onyx under this Article 5.0.
Onyx shall return all rejected Product(s) to SENN, provided that Onyx may retain
sample(s) of such reject Product(s) for laboratory testing and archival purposes
pursuant to this Article 5.0, but Onyx may not use any such sample(s) for any
human clinical testing or trials or for commercial sale.

 

5.2          Testing of Rejected Product(s). If Onyx rejects any of the
Product(s) pursuant to Section 5.1, SENN shall have an opportunity to conduct
its own tests to confirm such basis of rejection, which test

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

12

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SENN must conduct (if at all) within [*] of receipt of Onyx’s notice of
rejection pursuant to Section 5.1. SENN shall provide Onyx with all data and
results from any such testing by SENN hereunder.

 

(a)                                 Notwithstanding the foregoing, if Onyx
rejects the Product in accordance with Section 5.1 and SENN disagrees with the
basis for such rejection and notifies Onyx in writing of SENN’s disagreement
with such rejection no later than [*] after receipt of Onyx ‘s notice of
rejection pursuant to Section 5.1, then the Parties shall resolve such
disagreement as follows and in accordance with applicable cGMP Requirements and
the Quality Agreement: (i) representatives from both Parties shall promptly meet
to confirm that the methods of analysis are the same and are being executed in
the same manner; (ii) each Party shall send samples to the other for analysis;
(iii) after such analysis, the Parties shall discuss the results and use good
faith efforts for a period of [*] to reach agreement regarding such
disagreement; and (iv) in the event the Parties cannot resolve the matter, they
shall in good faith discuss and choose an independent Third Party laboratory to
perform the same methods of analysis on the disputed Product(s). The report of
such Third Party laboratory shall be in writing, addressed to both Parties and
shall state whether the disputed Product(s) were properly rejected pursuant to
Section 5.1, and shall be binding upon the Parties. Onyx and SENN shall share
equally the costs of retaining such Third Party laboratory for such testing, but
upon the issuance to the Parties of the Third Party’s report the prevailing
Party shall be promptly reimbursed by the other Party for its share of such
costs actually paid (if any).

 

(b)                                 In the event Onyx rejects
Product(s) pursuant to Section 5.1, and (i) SENN either agrees with (or chooses
not to contest) the reasons for such rejection or (ii) the Third Party
laboratory upholds Onyx’s rejection pursuant to Section 5.1, then at Onyx’s
written election provided promptly to SENN, SENN shall refund any and all
amounts paid (if any) to SENN for such rejected Product(s) and shall use best
efforts to replace all such rejected Product(s) with equivalent amount(s) of
replacement conforming Product(s) that comply with all the terms and conditions
of this Agreement as soon as commercially reasonable, as determined by the
Parties, and Onyx shall only be obligated to pay for such conforming replacement
Product(s) in compliance with the terms and conditions of this Agreement, after
such conforming replacement Product has been Released and delivered by SENN in
accordance with this Agreement. However, if SENN cannot provide such conforming
replacement Product(s) within the timeframe agreed upon by the Parties, in such
event SENN shall provide a credit to Onyx equal to the full amount of what Onyx
would have paid for replacement conforming Product if provided, and shall also
reimburse Onyx for the cost of all Onyx Materials used in connection with the
rejected Product(s). Nothing in this Article 5.0 shall permit SENN to terminate
or otherwise cancel any of its obligations under the applicable Order or any
other Order or to terminate this Agreement.

 

6.0          PRICE AND PAYMENT

 

6.1          Price; Price Increases. As consideration for SENN manufacturing and
supplying the Product(s) as provided in this Agreement (including the applicable
Order), SENN shall be paid the price applicable to such Product(s) as mutually
agreed upon in writing and in advance by the Parties and set forth in Exhibit B.
Such price shall be all-inclusive (including, without limitation, the cost of
labor, facilities, raw materials, reagents, solvents, analysis, packaging, waste
disposal, reports and delivery of the Product(s)) unless otherwise expressly
agreed to in writing by the Parties and specified in such Order. Onyx shall have
no obligation to reimburse SENN for any costs and expenses of SENN in excess of
such price

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

13

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

 

except as agreed to in writing by Onyx in its sole discretion. The Parties agree
that agreed upon pricing pursuant to this Agreement will not be increased during
the period ending [*], but that thereafter, the Parties will review such pricing
on an annual basis, and SENN may submit to Onyx proposed revised pricing
reflecting increases or decreases in labor or material costs for the upcoming
Calendar Year at least [*] prior to the start of such Calendar Year for which
such proposed revised pricing would become effective if it is agreed to by the
Parties; provided, however, that increases in agreed upon pricing pursuant to
this Agreement may not exceed [*] as determined by [*] for such time period.
Upon any mutual agreement on revised pricing during the Term, Onyx and SENN
shall execute an amended Exhibit B to this Agreement. All prices shall be stated
in United States dollars.

 

6.2          Payments. Except as otherwise agreed to by the Parties in writing,
within [*] of receipt by Onyx of SENN’s invoice and Onyx’s receipt and
acceptance of the Product(s) Released and delivered by SENN in accordance with
the terms and conditions of this Agreement, Onyx shall make the payment(s) to
SENN as specified in the payment schedule of the corresponding Order and the
agreed upon pricing. All invoices should be sent to Onyx (attn.: Accounts
Payable department at ap@onyx.com with a copy to the appropriate Supply Chain
representative) and must reference the appropriate Onyx Order number. If for any
reason (other than as caused by SENN) the Product(s) is not shipped promptly,
SENN shall be free to invoice Product within [*] of its Release and Onyx’s
acceptance. All payments shall be in Swiss francs (CHF), and shall be made by
wire transfer in accordance with written wire instructions sent by SENN to Onyx
(attn: Accounts Payable department at ap@onyx-pharm.com). If in the reasonable
opinion of Onyx, SENN has failed to perform or complete its performance
corresponding to an invoice, upon written notice to SENN by Onyx, Onyx shall
have the right to delay or withhold payment of such invoice (or portion thereof)
until such performance is complete and accepted as reasonably determined by
Onyx.

 

6.3          Interest. Any payments past due under this Agreement shall bear
interest calculated on a per annum basis from the due date to the date of actual
payment at a fluctuating interest rate equal at all time to the prime rate of
interest announced publicly from time to time by Citibank, N.A. (the “Prime
Rate”), but in no case higher than the maximum rate permitted by applicable Law.

 

7.0          BEST EFFORTS; WARRANTIES; REGULATORY MATTERS; WITHDRAWALS

 

7.1          Best Efforts. SENN covenants to Onyx to use all commercially
reasonable best efforts, using no less than commonly accepted professional
standards of workmanship in the pharmaceutical manufacturing industry, to
prepare and deliver as soon as Released the Product(s) to Onyx or a Third Party
designated by Onyx in writing. SENN covenants that it will not utilize any
process, Product or reagent in the preparation of Product(s) which to SENN’s
knowledge may infringe any issued patent or other intellectual property rights,
including but not limited to published patent applications, of a Third Party
without first obtaining Onyx’s prior written consent in its sole discretion.

 

7.2          SENN Representations, Warranties and Covenants. SENN represents,
warrants and covenants to Onyx that: (a) the Product(s) Released and delivered
by SENN hereunder shall have been manufactured, tested, packaged, stored,
handled and shipped in conformance with (i) all applicable Laws including those
regarding slavery and human trafficking and cGMP Requirements, (ii) the Master
Batch Record, (iii) the Specifications for such Product(s), (iv) this Agreement,
and (v) the Quality Agreement; (b) the Product(s) delivered by SENN hereunder
will be conveyed with good title, free and clear from any security interest,
lien or encumbrance; (c) SENN will maintain suitable records to verify SENN’s
compliance with this Section 7.2; (d) Onyx or its designee or any Governmental
Authority may audit or inspect such records during SENN’s normal business hours;
and (e) SENN has the operational and financial wherewithal to perform all of the
obligations it has undertaken herein.

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

14

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

 

7.3          Additional Representations and Warranties.

 

(a)                                 SENN warrants and represents to Onyx that
SENN has full corporate power and authority to enter into this Agreement and to
carry out the provisions hereof, and that the execution, delivery and
performance of this Agreement by SENN does not conflict with any agreement,
instrument or understanding, oral or written, to which it is a party or by which
it may be bound, nor does it violate any Law of any court, governmental body or
administrative or other agency having jurisdiction over it. SENN covenants to
Onyx that SENN will not grant any right to any Third Party that would conflict
with the rights granted to Onyx under this Agreement.

 

(b)                                 Onyx warrants and represents to SENN that
Onyx has full corporate power and authority to enter into this Agreement and to
carry out the provisions hereof, and that the execution, delivery and
performance of this Agreement by Onyx does not conflict with any agreement,
instrument or understanding, oral or written, to which it is a party or by which
it may be bound, nor does it violate any Law of any court, governmental body or
administrative or other agency having jurisdiction over it. Onyx covenants to
SENN that Onyx will not grant any right to any Third Party that would conflict
with the rights granted to SENN under this Agreement.

 

7.4          Debarment. In accordance with the requirements of the FDA Act and
the Debarment Act, SENN certifies, warrants and represents to Onyx that SENN is
not and will not be using any person that has been debarred or is under
investigation for debarment or disqualification in any capacity in connection
with SENN’s performance under this Agreement. SENN also certifies, warrants and
represents to Onyx that SENN is not and will not be using any person or
affiliate person/firm who has been convicted of a crime for conduct related to
the production or handling of a drug product in any capacity in connection with
SENN’s performance under this Agreement. If at any time during the Term of this
Agreement, SENN becomes aware that SENN or any person employed or any affiliate
person/firm has been or is in the process of being debarred or disqualified or
would be covered by any other provision of this Section 7.3, SENN will
immediately notify Onyx thereof in writing and take corrective action as
requested by Onyx (at SENN’s expense).

 

7.5          Governmental Licenses and Permits for SENN Facility. SENN shall
obtain and maintain all governmental licenses and permits necessary to establish
and operate the SENN Facility for performance hereunder, including but not
limited to those required by the FDA or any other Governmental Authority. SENN
shall operate the SENN Facility in compliance with all applicable Laws,
including cGMP Requirements, and SENN shall immediately notify Onyx in writing
if any Governmental Authority issues a finding that affects SENN’s ability to
perform under this Agreement.

 

7.6          Regulatory Matters. Notwithstanding anything contained in this
Agreement to the contrary, SENN shall not initiate or participate in any
communications with the FDA or any other Governmental Authority concerning the
Product(s), the Pharmaceutical Product(s) or any other matter relating to this
Agreement unless required by applicable Law or requested to do so by Onyx, and
then only upon prior consultation with Onyx. If any Governmental Authority
conducts or gives notice to SENN of its intent to conduct any audit or
inspection at the SENN Facility or take any other regulatory action that relates
to or impacts any aspect of SENN’s performance under this Agreement, SENN will
promptly give Onyx notice thereof, including all information pertinent thereto,
and shall coordinate with Onyx in connection therewith; provided, however, that
Onyx acknowledges that Onyx may not direct the manner in which SENN fulfils its
obligations to permit audit or inspection by Governmental Authorities.

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

15

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7.7          Onyx Audits.

 

(a)                                 Quality Audits. Onyx, upon prior written
notice and during normal business hours, Onyx shall have the right to audit and
inspect SENN’s records, including without limitation the Master Batch Record,
Release Documentation, other Work Product and the portions of the SENN Facility
and equipment used pursuant to this Agreement, [*] at no charge to Onyx. If Onyx
chooses to audit SENN more than [*], Onyx agrees to reimburse SENN for SENN’s
reasonable expenses incurred in hosting any such audit. Notwithstanding the
foregoing, there shall be no limit on the number of for-cause audits, and the
costs and expenses of any for-cause audit shall be borne by SENN.

 

(b)                                 Financial Audits. Onyx shall have the right
to audit pre-agreed records related to the balance sheet of SENN. SENN will keep
those records available in accordance with International Financial Standards.
Onyx shall have the right to audit the aforementioned pre-agreed books and
records, kept by or under the control of SENN, including, but not limited to
those kept by SENN, its employees, agents, assigns, successors and
subcontractors. SENN shall maintain such accurate records to permit sufficient
verification of costs incurred under this Agreement with such supporting or
underlying documents and materials, for the duration of this Agreement and for
at least [*] following the completion of this Agreement, including any and all
renewals thereof. The books and records, together with the supporting or
underlying documents and materials shall be made available, upon request, to
Onyx, through its employees, agents, representatives, contractors or other
designees, during normal business hours at SENN’s office or place of business,
or if mutually agreed to by the Parties,, such books and records, together with
the supporting or underlying documents and records, shall be made available for
audit at a time and location which is convenient for Onyx. Furthermore, Onyx
shall have the right to [*] update of SENN’s balance sheet (including all debt)
and net working capital. SENN reserves the right to limit disclosure of books
and records covered by legally binding non-disclosure agreements with clients.

 

7.8          Withdrawals or Recalls. Onyx shall have the sole discretion to
withdraw or recall any Product(s) or Pharmaceutical Product(s), and shall be
responsible for directing all administrative and regulatory actions relating
thereto. In the event that Onyx withdraws or removes any Product(s) manufactured
and supplied by SENN (or any Pharmaceutical Product(s) arising therefrom), SENN
shall cooperate with Onyx as reasonably requested in connection with any such
withdrawal or removal, including by complying with all applicable Laws. The
withdrawal or recall costs and expenses shall be included within the scope of
costs and expenses covered by Sections 11.1 and 11.2, provided that if the
withdrawal or recall arises solely from acts or omissions of SENN in its
performance under this Agreement, the withdrawal or recall costs shall be borne
by SENN.

 

8.0          TECHNOLOGY OWNERSHIP AND LICENSES

 

8.1          Background Technology of Onyx. All Background Technology of Onyx is
and shall remain the exclusive property of Onyx. Onyx hereby grants to SENN, for
the Term of this Agreement, a non-exclusive, fully-paid-up, royalty-free license
(with no right to sublicense except with Onyx’s prior written consent) in the
Territory to use such Background Technology of Onyx solely for the purpose of,
and only to the extent necessary for, SENN’s performance under this Agreement.

 

8.2          Background Technology of SENN. All Background Technology of SENN is
and shall remain the exclusive property of SENN. SENN hereby grants to Onyx and
its Affiliates a non-exclusive, fully paid-

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

16

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up, royalty-free, perpetual, irrevocable, fully transferable license (with the
right to sublicense) in the Territory to use such Background Technology of SENN
solely for the purpose of, and only to the extent necessary for, Onyx’s and its
Affiliates’ full use and enjoyment (including the development and
commercialization of Pharmaceutical Products) of the Work Product and Agreement
Technology.

 

8.3          Ownership of Work Product and Agreement Technology. Except as
expressly provided in Section 8.4, all Work Product and Agreement Technology
shall, upon creation, be owned exclusively by Onyx. SENN hereby assigns to Onyx
all rights SENN or its subcontractors (if any) or their respective directors,
officers, employees, agents or representatives may have in the Agreement
Technology, and to any and all Work Product. SENN shall neither transfer to a
Third Party nor derive any commercial benefit from any Agreement Technology or
Work Product, other than as expressly set forth in Section 8.4.

 

8.4.         Exception For General Applicability. Notwithstanding Section 8.3,
Work Product and Agreement Technology generated or derived by SENN in the course
of performing under this Agreement that has general application to manufacturing
processes or formulation development of drug products or drug delivery systems
shall, for such general purposes, be the exclusive property of SENN. SENN hereby
grants to Onyx and its Affiliates a non-exclusive, fully paid-up, royalty free,
perpetual, irrevocable, fully transferable license (with the right to
sublicense) in the Territory under such Work Product and Agreement Technology
solely for the purpose of, and only to the extent necessary for, Onyx’s and its
Affiliates full use and enjoyment (including the development and
commercialization of Pharmaceutical Products) of the Work Product and Agreement
Technology pursuant to this Agreement including Section 8.3.

 

8.5          Third Party Technology. If and to the extent SENN proposes to use
any Third Party Technology for purposes of this Agreement, SENN shall first
obtain the prior written consent of Onyx (in its sole discretion) thereto, and
in connection with any use of Third Party Technology for purposes of this
Agreement, SENN hereby automatically grants to Onyx and its Affiliates a
non-exclusive, fully paid-up, royalty-free, perpetual, irrevocable, fully
transferable license (with the right to sublicense) in the Territory under such
Third Party Technology solely for the purpose of, and only to the extent
necessary for, Onyx’s and its Affiliates full use and enjoyment (including the
development and commercialization of Pharmaceutical Product(s)) of the Work
Product and Agreement Technology pursuant to this Agreement including
Section 8.3. SENN (or its Third Party licensor) shall retain all right, title
and interest in and to the Third Party Technology, subject to the
license(s) granted pursuant to this Section 8.5.

 

8.6          Execution of Documents. If requested by a Party, the other Party
shall execute any and all documents necessary to assign or perfect the first
Party’s ownership or evidence such Party’s license rights, as the case may be,
in Agreement Technology, Agreement Technology Patent Rights, Background
Technology, Background Technology Patent Rights, Work Product and/or Third Party
Technology, at the requesting Party’s reasonable expense.

 

8.7          No Implied Licenses. Except as expressly agreed to by the Parties
in this Agreement, nothing contained herein, nor the delivery of any
Confidential Information of one Party to the other, shall be deemed to grant any
right or license under any patent or patent applications or to any intellectual
property of the one Party to the other Party.

 

9.0          CONFIDENTIALITY

 

9.1          Confidentiality. With respect to the Confidential Information of
the other Party and/or its Affiliates, each Party agrees (a) to hold such
Confidential Information in strict confidence and take reasonable precautions to
protect such Confidential Information (including, without limitation, all

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

17

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

 

precautions the receiving Party normally employs with respect to its own
confidential information), (b) to not divulge any such Confidential Information
to any Third Party (other than parties specifically permitted to receive such
Confidential Information pursuant to the terms of this Agreement), (c) to not
make any use whatsoever at any time of such Confidential Information except as
permitted under this Agreement (including Section 8.0), (d) to not derive any
commercial benefit (whether direct or indirect) from such Confidential
Information (other than pursuant to performance of this Agreement), and (e) to
not copy (except as may be necessary to accomplish the purposes of this
Agreement) or reverse engineer any such Confidential Information.

 

9.2          Exceptions. A Party’s obligation of confidentiality under this
Agreement shall not apply to information that the other party can demonstrate by
reasonable documentary evidence:

 

(a)                                 was in its possession prior to receipt from
the disclosing Party (or, in the case of Work Product, prior to its generation
under this Agreement);

 

(b)                                 was in the public domain at the time of
receipt from the disclosing Party (or, in the case of Work Product, prior to its
generation under this Agreement);

 

(c)                                  becomes part of the public domain without
breach of such Party’s obligations of confidentiality under this Agreement; or

 

(d)                                 is lawfully received by the receiving Party
from a Third Party and the receiving Party has no obligation of confidentiality
to the disclosing Party with respect to such information. Notwithstanding the
foregoing, (i) information shall not fall within an exception set forth in this
Section 9.2 merely because such information is embraced by more general
information in the public domain or in the possession of the receiving Party,
and (ii) the fact that any Work Product may fall within one or more of the
exceptions set forth in this Section 9.2 shall not relieve SENN of its
obligations under Sections 8.0 or 9.1 with respect to Work Product.

 

9.3          Required Disclosure. In the event a Party is required to disclose
Confidential Information of the other Party or its Affiliates pursuant to an
order of a court or other Governmental Authority with valid jurisdiction, the
receiving Party may disclose such Confidential Information, but (a) only after
providing the disclosing Party with reasonable advance notice thereof (as
feasible) to enable the disclosing Party to seek a protective order or otherwise
seek to prevent such disclosure, and (b) only to the extent of such required
disclosure. Nothing herein shall require a Party to take or refrain from taking
any action in violation of any legal process.

 

9.4.         Disclosures on Need to Know Basis. Each Party shall limit the
disclosure of Confidential Information of the other Party or its Affiliates to
the receiving Party or such receiving Party’s Affiliates or their respective
directors, officers, employees, auditors, representatives or agents (and in the
case of SENN, to its permitted subcontractors, if any), in each case who have a
legitimate “need to know” and who are bound in writing to observe the
confidentiality obligations of this Agreement or similarly stringent provisions.

 

9.5.         Return or Destruction of Confidential Information. Except as
otherwise specified in this Agreement, each Party shall, upon the written
request of the other Party, turn over to the disclosing Party all Confidential
Information of the disclosing Party in the possession or control (including any
copies or extracts thereof) of the receiving Party and its Affiliates, or
destroy such records and certify the destruction thereof in writing to the
disclosing Party, except that copies of any such Confidential

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

18

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

 

Information may be retained for archive purposes or to comply with this
Agreement and/or applicable Law.

 

9.6.         Equitable Relief. Each party acknowledges and agrees that due to
the unique nature of the disclosing Party’s Confidential Information, there can
be no adequate remedy at law for any breach of its obligations hereunder, that
any such breach may allow the receiving Party or Third Parties to unfairly
compete with the disclosing Party, and therefore, that upon any such breach or
any threat thereof, the disclosing Party shall be entitled to seek appropriate
equitable relief in addition to whatever remedies it might have at law. The
receiving Party shall notify the disclosing Party in writing immediately upon
the occurrence of any such unauthorized release or other breach of which the
receiving Party becomes aware.

 

9.7.         Survival. The obligations of each Party with respect to
Confidential Information of the other Party shall continue in effect until [*]
after the expiration or termination of this Agreement.

 

10.0        TERM AND TERMINATION

 

10.1        Term And Termination. This Agreement shall be effective on the
Effective Date and shall continue until sooner terminated or until expiration on
December 31, 2016 (the “Term”).

 

10.2        Onyx Right to Terminate Agreement Without Cause. Onyx shall have the
right at any time to terminate this Agreement, in whole or in part, without
cause, upon at least six (6) months’ advance written notice from Onyx to SENN in
order to terminate this Agreement. Upon receipt of any such Onyx notice of
termination under this Section 10.2, SENN shall discontinue performing services
except as otherwise agreed in writing by the Parties with respect to the
Agreement or any Order(s) so terminated. Such termination shall not relieve Onyx
of its obligations under this Agreement or any such Order(s). Consistent with
the other terms and conditions of this Agreement, Onyx shall own all raw
materials, in process materials, Product(s) and Release Documentation arising
under or otherwise resulting from SENN’s performance under this Agreement or for
which SENN was reimbursed by Onyx under this Section 10.2.

 

10.3        Termination for Cause. Each Party is entitled (without prejudice to
its other rights and remedies under this Agreement or at law or in equity) to
terminate this Agreement at any time if the other Party fails to perform any
material obligation, covenant, condition or term of this Agreement or the
Quality Agreement, provided such other Party shall not have remedied its failure
within [*] (the “Cure Period”) after receipt of written notice from the
terminating party setting forth the nature of such failure. If such breach has
not been remedied within the Cure Period, the other Party may terminate this
Agreement effective immediately upon written notice of termination to the
breaching Party. Either Party shall be deemed to have breached this Agreement in
the event: (a) such Party voluntarily or involuntarily enters a bankruptcy or
similar proceeding; (b) such Party passes a resolution for the winding up of its
business or a court of competent jurisdiction makes an order to that effect;
(c) a receiver is appointed in respect of substantially all of its assets; or
(d) a petition for bankruptcy, reorganization or arrangement is filed by a Third
Party and such filing is not withdrawn within [*] of the filing date. If this
Agreement is terminated by Onyx under this Section 10.3, Onyx shall have the
right to require SENN to transfer manufacturing documentation and technology as
provided herein. In the event of any such termination by Onyx, commencing
promptly upon the effective date of such termination, SENN will transfer to Onyx
or its designee the most current versions of all Work Product, Agreement
Technology and other materials, regulatory documentation and other information
at SENN necessary to undertake the manufacture and supply of the Product(s), and
shall make SENN’s personnel and other resources reasonably available as
necessary to effect an orderly transition to alternate supplier(s) designated by
Onyx. Such transfer shall be completed within three (3) months after the
effective date of such termination, and SENN shall bear all of

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

19

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

 

its costs and expenses associated with this Section 10.3. In connection
therewith, any such alternate supplier(s) shall automatically be sublicensees of
Onyx’s rights under Article 8.0.

 

10.4        Cessation of Manufacture. If this Agreement is terminated for any
reason other than termination by Onyx pursuant to Section 10.2 or termination by
SENN for cause pursuant to Section 10.3, SENN shall provide Onyx with the
opportunity to purchase up to [*] of inventory of Product(s) at the pricing then
in effect at the time of the notice of termination, with the amount of such
inventory of Product(s) for such up-to-[*] period being determined with
reference to the amount [*].

 

10.5        Other Effects of Termination or Expiration. In connection with
expiration or any termination of this Agreement, SENN shall fully cooperate with
Onyx at Onyx’s reasonable expense (except in the case of termination by Onyx
under Section 10.3, in which case SENN shall bear such costs) regarding the
disposition of all materials, Product(s) and information (including Confidential
Information). Any rights or obligations which by their nature are intended to
survive expiration or termination of this Agreement shall survive such
expiration or termination, including, but not limited to, the provisions of
Sections 7.0-9.0, 11.0, 12.0 and this Section 10.4.

 

11.0        INDEMNIFICATION AND INSURANCE

 

11.1        Onyx Indemnity. Onyx shall indemnify, defend and hold harmless, SENN
and its directors, officers, employees and agents, from and against any and all
liability, damage, loss, cost (including reasonable attorneys’ fees) and expense
resulting from claims of any kind and character by any Third Party (including,
without limitation, for purposes of this Section 11.1 employees or agents of
Onyx) with respect to the Product(s) supplied to and accepted by Onyx pursuant
to this Agreement. Notwithstanding the foregoing, SENN and its directors,
officers, employees and agents shall not be entitled to indemnification under
this Section 11.1 against any claim to the extent resulting from (a) the
negligence or wilful misconduct of SENN or its subcontractors or any of their
respective directors, officers, employees or agents, (b) any accident at SENN or
any subcontractor which may arise in the course of SENN’s or such
subcontractor’s performance under this Agreement, or (c) the breach by SENN or
its subcontractor of any of the terms or conditions of this Agreement, including
without limitation any representations, warranties or covenants of SENN under
this Agreement.

 

11.2        SENN Indemnity. SENN shall indemnify, defend and hold harmless, Onyx
and its directors, officers, employees and agents, from and against any and all
liability, damage, loss, cost (including reasonable attorneys’ fees) and expense
resulting from claims of any kind and character by any Third Party (including,
without limitation, for purposes of this Section 11.2 directors, officers,
employees or agents of SENN or its subcontractors, if any) arising out of or in
connection with SENN’s or its subcontractors performance under this Agreement,
including but not limited to (a) the negligence or wilful misconduct of SENN or
its subcontractors or their respective directors, officers, employees or agents,
(b) any accident at SENN or its subcontractors which may arise in the course of
SENN’s or such subcontractor’s performance under this Agreement, or (c) the
breach by SENN or its subcontractor of any of the terms or conditions of this
Agreement, including without limitation any representations, warranties or
covenants under this Agreement. Notwithstanding the foregoing, Onyx and its
directors, officers, employees and agents shall not be entitled to
indemnification under this Section 11.2 against any claim to the extent
resulting from (a) the negligence or wilful misconduct of Onyx or its directors,
officers, employees or agents, (b) any accident at Onyx which may arise in the
course of Onyx’s performance under this Agreement, or (c) the breach by Onyx of
any of the terms or conditions of this Agreement, including without limitation
any representations, warranties or covenants of Onyx under this Agreement.

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

20

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

 

 

11.3        Limitation of Liability. Notwithstanding anything to the contrary
herein, neither Party shall be liable to the other for indirect, incidental,
consequential, special, exemplary or punitive damages arising out this
Agreement, except for any liability as an Indemnitor.

 

11.4        Indemnification Procedures. A Party (the “Indemnitee”) which intends
to claim indemnification under this Section 17 shall promptly notify the other
Party (the “Indemnitor”) in writing of any action, claim or other matter in
respect of which the Indemnitee or any of its directors, officers or employees
intend to claim such indemnification; provided, however, that the failure to
provide such notice within a reasonable period of time shall not relieve the
Indemnitor of any of its obligations hereunder except to the extent the
Indemnitor is prejudiced by such failure. The Indemnitee and its directors,
officers or employees and agents shall cooperate fully with the Indemnitor and
its legal representatives in the investigation, negotiation, compromise,
settlement and defense of any action, claim or other matter covered by this
indemnification, at the Indemnitor’s sole cost and expense. The Indemnitor shall
be in charge of and control of any such investigation, negotiation, compromise,
settlement and defense and shall have the right to select counsel with respect
thereto. In no event shall the Indemnitor or Indemnitee compromise or settle any
such matter which admits fault or requires any obligation on the part of
Indemnitor without the prior written consent of the other party, which shall not
be bound by any such compromise or settlement absent its prior written consent,
which consent shall not be unreasonably withheld or delayed. The Indemnitee
shall have the right, but not the obligation, to be represented by counsel of
its own selection and at its own cost and expense.

 

11.5        Insurance.

 

(a)                                 SENN and Onyx shall secure and maintain in
full force and effect throughout the Term of this Agreement and for at least [*]
thereafter policies of insurance for (i) worker’s compensation and (ii) general
liability having policy limits, deductibles and other terms appropriate to the
conduct of SENN’s and Onyx’s respective businesses, in each case as required by
applicable Law and in each Party’s reasonable judgment; provided, however, that
such coverage shall not be less than [*] per occurrence, and [*] in annual,
aggregate coverage.

 

(b)                                 The insurance set forth above shall also
cover the insured Party’s indemnification obligations under this Agreement, but
any coverage limits therein shall not operate to limit such Party’s liability
hereunder.

 

(c)                                  Each Party shall provide the other with
written evidence of insurance upon the other Party’s written request, and shall
give the other Party at least thirty (30) days’ prior, written notice of the
cancellation or non-renewal of, and/or adverse, material change in, any such
insurance.

 

12.0      MISCELLANEOUS

 

12.1      Assignment. Onyx may assign this Agreement without SENN’s consent.
SENN may not delegate, transfer, convey, assign or pledge any of its rights or
obligations under this Agreement to any Third Party without the prior written
consent of Onyx, which shall not be unreasonably withheld or delayed. Any
permitted assignee of a Party shall assume all obligations of its assignor under
this Agreement, and no assignment shall relieve either Party of responsibility
for the performance of any of its obligations that accrued prior to the
effective date of such assignment. Without limiting the foregoing, if SENN
enters into any transaction or series of transactions that would constitute a
change of “control”(as defined in Section 1.1) of SENN, SENN shall notify Onyx
in writing thereof within five (5) days of having entered

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

21

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into such agreement(s); provided, however, that if such transaction(s) have not
been publicly announced at the time of such notice to Onyx hereunder, Onyx shall
treat such notice as Confidential Information of SENN for purposes of such
Agreement, subject to the terms of Article 9.0. Upon any notice from SENN to
Onyx pursuant to this Section 12.1, SENN or its proposed assignee of this
Agreement shall provide Onyx with the opportunity to purchase up to [*] of
inventory of Product(s) at the pricing then in effect at the time of such
notice, with the amount of such inventory of Product(s) for such up-to-[*]
period being determined with reference to the amount [*].

 

12.2      Waiver. No provision of this Agreement shall be waived by any act,
omission or knowledge of a Party or its agents or employees except by an
instrument in writing expressly waiving such provision and signed by a duly
authorized officer of the waiving Party.

 

12.3      Severability. Whenever possible, each provision of this Agreement will
be interpreted in such manner as to be effective and valid under applicable Law,
but if any provision of this Agreement is held to be prohibited by or invalid
under applicable Law, such provision will be ineffective only to the extent of
such prohibition or invalidity without invalidating the remainder of this
Agreement.

 

12.4      Independent Contractors. The relationship between Onyx and SENN
created by this Agreement is one of independent contractors and neither Party
shall have the power or authority to bind or obligate the other. Each Party
shall use its own discretion and shall have complete and authoritative control
over its employees and the details of performing its obligations under this
Agreement.

 

12.5      Force Majeure. Neither Party shall be liable for its failure to
perform hereunder as a result of any event of force majeure (“Force Majeure”)
beyond the Party’s reasonable control including, but not limited to, acts of
God, fire, flood, wars, terrorism, sabotage, civil strife or demonstrations,
accidents, strikes, lockouts or other labor disputes, shortages, government
actions, or inability to obtain supplies, raw materials or transportation. If
either Party’s performance is prevented in whole or part by any such event of
Force Majeure, such Party shall be excused from performance hereunder during the
period of delay of performance resulting from such event of Force Majeure, and
the affected Party shall give prompt written notice of the same and its expected
duration to the other Party; provided, however, that the affected Party shall
take all commercially reasonable steps to remedy the impact of the event of
Force Majeure upon its performance hereunder with all reasonable dispatch.

 

12.6      Entire Agreement; Amendment; Termination of MSA. This Agreement
constitutes the full understanding of the Parties and is a final, complete and
exclusive statement of the terms and conditions of their agreement regarding the
subject matter hereof. Without limiting the foregoing, the Parties agree that
effective as of the Effective Date, the MSA is hereby terminated by mutual
written agreement solely with respect to any and all Product(s) manufactured or
sourced by SENN for Onyx pursuant to this Agreement, notwithstanding any
provisions of the MSA to the contrary; provided, however, that each Party shall
continue to be bound by any and all obligations arising under the MSA prior to
such effective date of its termination, and provided, further, that the MSA
shall remain in effect as to any materials or products developed or manufactured
(or in the process of being developed or manufactured) under a purchase order
under the MSA that are not Product(s) sourced or manufactured under this
Agreement. While purchase orders, invoices or similar routine documents may be
used to implement or administer provisions of this Agreement, any provisions of
such documents which add to, vary, modify or in conflict with the terms and
conditions of this Agreement shall be deemed inoperative and deleted, and shall
have no force or effect of either Party’s rights or obligations under this
Agreement, and this Agreement shall be deemed controlling. No amendment or
modification of this Agreement shall be effective unless made in writing and
signed by a duly authorized representative of each Party.

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

22

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

 

12.7      Governing Law. This Agreement shall be governed by the laws of [*]
(excluding the 1980 United Nations Convention on Contracts for the International
Sale of Goods) irrespective of its conflicts of laws principles.

 

12.8      Use of Names. Each Party agrees not to use the name of the other Party
(or its Affiliates, or Pharmaceutical Products) or any of their respective
personnel in any public announcements, publicity, promotional literature or
advertising without the prior written approval of the other Party.
Notwithstanding the above, Onyx shall be permitted to use the names of SENN and
any of its subcontractors (if any) in connection with regulatory filings and
communications relating to the Product(s) or the Pharmaceutical Product(s).

 

12.9      Notices. Except as otherwise expressly provided in this Agreement, any
notice to be given to a Party under or in connection with this Agreement shall
be in writing and shall be delivered (a) personally, (b) by a nationally
recognized overnight courier or by certified mail, postage prepaid, return
receipt requested, (c) via facsimile, with receipt confirmed, or (d) if actually
received, by U.S. mail, addressed to such Party as follows: (i) if to SENN: to
Senn Chemicals AG Attn: Elizabeth Hoffner and Carlo Hächler P. 0. Box 26718157
Dielsdorf I Switzerland I Phone [*] Fax [*]; (ii) if to Onyx, to Dammstrasse 19,
6300 Zug Switzerland Attn: General Manager; with a copy to Onyx Pharmaceuticals,
Inc., 249 East Grand Avenue, South San Francisco, CA 94080 USA ATTN: General
Counsel; or to such other address as the addressee shall have last furnished in 
writing to the addressor and shall be effective upon receipt by the addressee.

 

12.10    Headings. The descriptive headings of this Agreement are for
convenience only and shall be of no force or effect in construing or
interpreting any of the provisions of this Master Services Agreement.

 

12.11    Counterparts. This Agreement may be executed in one or more
counterparts, each of which will be deemed an original, and all of which
together shall constitute one and the same instrument.

 

ONYX PHARMACEUTICALS INTERNATIONAL GMBH SENN CHEMICALS AG

 

By:

/s/ [*] 30.08.2012

 

By:

/s/ Carlo Hächler

Name:

[*]

 

Name:

Carlo Hächler

Title:

[*]

 

Title:

CEO

 

 

 

 

 

 

 

 

 

 

 

/s/Elizabeth Hoffner 2 Sept 12

 

 

 

Elizabeth Hoffner

 

 

 

Director

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

23

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

 

Exhibit A

Products and Specifications

 

[*]

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

24

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

 

Exhibit B

Pricing

 

[*]

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

25

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

 

Exhibit C

Onyx Materials and Onyx Equipment

 

[*]

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

26

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

 

Acknowledgement of Receipt

 

On behalf of Senn Chemicals AG, Guido-Senn Strasse 1, Dielsdorf, Switzerland, I
hereby confirm receipt of one (1) fully executed wet ink original(s) of the
following agreement:

 

Contract Manufacturing Agreement, concluded between

 

Onyx Pharmaceuticals International GmbH and Senn Chemicals AG.

 

 

Date of receipt: 3 Sep2012

 

 

Senn Chemicals AG

 

 

 

 

 

 

 

By:

/s/ Elizabeth Hoffner, 2 Sept 12

 

 

Signature

 

 

Elizabeth Hoffner

 

Name:

 

 

 

 

 

Title:

Director

 

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

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

27

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