Document:

EXHIBIT 10.3

                                                         April 9, 2006

Cable & Co. Worldwide, Inc.
800 Third Avenue
21st Floor
New York, New York 10022
Attention:   Martin C. Licht

Gentlemen:

         We  are  pleased  to set  forth  the  terms  of  the  retention  of the
undersigned  individuals  (collectively,  the  "CONSULTANTS")  by  Cable  &  Co.
Worldwide, Inc. (collectively with its affiliates the "COMPANY").

         1.  The  Company  hereby  retains  the  Consultants  as  the  Company's
non-exclusive  consultants  relating  to the  proposed  operations,  sales,  and
marketing of the Company's products in Europe (the "CONSULTING Relationship").

         2. In connection with the Consulting Relationship, the Consultants will
be required to familiarize themselves with the business, operations, properties,
financial  condition,  and prospects of the Company. In connection with its role
as the Company's advisor, the Consultants would expect their services to include
such  additional  financial  advisory  and  related  services as may be mutually
agreed upon by the  Consultants  and the Company.  The  Consulting  Relationship
shall be for a period of six months.

         3. In connection  with the  Consulting  Relationship,  the Company will
cooperate  with  the  Consultants  and will  furnish  the  Consultants  with all
information  and data  concerning  the Company  (the  "INFORMATION"),  which the
Consultants deem appropriate and will provide the Consultants with access to the
Company's officers,  directors,  employees,  independent accountants,  and legal
counsel.  The Company  represents  and warrants that all  Information to be made
available to the  Consultants  by the Company will, at all times during the term
hereof,  be complete and correct in all  material  respects and will not contain
any  untrue  statement  of a  material  fact or omit to  state a  material  fact
required  to be stated  therein  or  necessary  in order to make the  statements
therein  not  misleading  in the light of the  circumstances  under  which  such
statements  are made.  The Company  further  represents  and  warrants  that any
projections provided by it to the Consultants will be prepared in good faith and
will be based upon assumptions which, in light of the circumstances  under which
they are made,  are  reasonable.  The Company  acknowledges  and agrees that, in
rendering its services under this Agreement,  the Consultants  will be using and
relying  on the  Information  without  independent  verification  thereof by any
Consultant or  independent  appraisal by any  Consultant of any of the Company's
assets.  The Consultants shall not be required to assume  responsibility for any
information  regarding the Company.  Any advice to be rendered by any Consultant
pursuant hereto may not be disclosed  publicly without the prior written consent
of the Consultants.

         4. (a) In consideration of the Consulting Relationship, the Consultants
shall be entitled to receive an aggregate cash payment in the amount of $49,000,
allocated as set forth in

                                      -14-
<PAGE>

Annex A hereto.  The  Consultants  acknowledge  and agree that such sum shall be
payable  solely from the positive  operating cash flow generated by the sales of
the Company's products in Italy.

                  (b) The parties hereto expressly agree that any  consideration
payable pursuant hereto for the services described therein shall be as set forth
therein.

         5. In addition to the fees described in Paragraph 4 above,  the Company
agrees to promptly reimburse the Consultants for expenses incurred in connection
with the Consulting Relation when incurred or promptly thereafter, provided that
such expenses have been approved in advance by the Company.

         6. Either party hereto may terminate this Agreement at any time upon 30
days' prior written notice, without liability or continuing  obligation,  except
as set forth in the following sentence.  The termination of this Agreement shall
not affect: (i) any compensation earned by the Consultants hereunder,  including
the  entirety  of  the  fees   referenced  in  Paragraph  3  hereof;   (ii)  the
reimbursement  of  expenses  incurred  by  the  Consultants  up to the  date  of
termination  or  completion,  as the case may be;  and (iii) the  provisions  of
Paragraphs 3 through 7 of this Agreement.

         7. The validity and  interpretation of this Agreement shall be governed
by the laws of the State of New York  applicable  to  agreements  made and to be
fully performed therein.  The Company irrevocably submits to the jurisdiction of
any court of the State of New York or the United States  District  Court for the
Southern District of the State of New York for the purpose of any suit,  action,
or other proceeding  arising out of this Agreement,  or any of the agreements or
transactions contemplated hereby, which is brought by or against the Company and
(i)  hereby  irrevocably  agrees  that all  claims in  respect of any such suit,
action,  or proceeding may be heard and determined in any such court and (ii) to
the extent that the Company has acquired, or hereafter may acquire, any immunity
from  jurisdiction  of any such  court or from any legal  process  therein,  the
Company  hereby waives,  to the fullest extent  permitted by law, such immunity.
The Company hereby waives, and agrees not to assert in any such suit, action, or
proceeding, in each case, to the fullest extent permitted by applicable law, any
claim that (a) the Company is not personally  subject to the jurisdiction of any
such court,  (b) the Company is immune from any legal process  (whether  through
service or notice, attachment prior to judgment, attachment in aid of execution,
execution,  or otherwise) with respect to the Company's property or (c) any such
suit, action, or proceeding is brought in an inconvenient forum.

         8.  The  benefits  of this  Agreement  shall  inure  to the  respective
successors  and assigns of the  parties  hereto and of the  indemnified  parties
hereunder  and  their  successors  and  assigns  and  representatives,  and  the
obligations  and  liabilities  assumed in this  Agreement by the parties  hereto
shall be binding upon their respective successors and assigns.

         9.  For  the  convenience  of  the  parties   hereto,   any  number  of
counterparts of this Agreement may be executed by the parties hereto.  Each such
counterpart shall be, and shall be deemed to be, an original instrument, but all
such  counterparts  taken together shall  constitute one and the same Agreement.
This  Agreement may not be modified or amended  except in writing  signed by the
parties hereto.

                [REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK]

<PAGE>

         If the foregoing  correctly sets forth our  Agreement,  please sign the
enclosed copy of this letter in the space provided and return it to us.

                                            Very truly yours,

                                            -----------------------------
                                            NAME: NUNZIO ALTOBELLI

                                            -----------------------------
                                            NAME: JOHN DOUGLAS ASTON

                                            -----------------------------
                                            NAME: FRANK OTTAVIANI

                                            -----------------------------
                                            NAME: ANNEMARIE HARDT

CONFIRMED AND AGREED TO:
THIS _______ DAY OF APRIL, 2006

CABLE & CO. WORLDWIDE, INC.

BY:
   ---------------------------
   NAME:
   TITLE:

<PAGE>

                                                                         ANNEX A

             NAME                        AMOUNT
             ----                        ------

             Nunzio Altobelli            $18,750
             John Douglas Aston          $16,250
             Frank Ottaviani             $ 8,750
             Annemarie Hardt             $ 6,250

                      TOTAL              $49,000exv10w24

 

Exhibit 10.24

Execution Draft February 1, 2006

Manufacturing Services Agreement

Between

Patheon Pharmaceuticals Inc.

and

Somaxon Pharmaceuticals, Inc.

February 1, 2006

CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

 

Table of Contents

	 	 	 	 	 	 	 
	ARTICLE 1. INTERPRETATION	 	 	1	 
	 
	 	 	 	 	 	 
	     1.1
	 	Definitions	 	 	 1	 
	     1.2
	 	Currency	 	 	 6	 
	     1.3
	 	Sections and Headings	 	 	 6	 
	     1.4
	 	Singular Terms	 	 	 6	 
	     1.5
	 	Schedules	 	 	 6	 
	 
	 	 	 	 	 	 
	ARTICLE 2. PATHEON’S MANUFACTURING SERVICES	 	 	7	 
	 
	 	 	 	 	 	 
	     2.1
	 	Manufacturing Services	 	 	 7	 
	     2.2
	 	Standard of Performance	 	 	 9	 
	 
	 	 	 	 	 	 
	ARTICLE 3. CLIENT’S OBLIGATIONS	 	 	9	 
	 
	 	 	 	 	 	 
	     3.1
	 	Payment	 	 	 9	 
	 
	 	 	 	 	 	 
	ARTICLE 4. CONVERSION FEES AND COMPONENT COSTS	 	 	9	 
	 
	 	 	 	 	 	 
	     4.1
	 	[***] Pricing	 	 	 9	 
	     4.2
	 	Price
Adjustments - Subsequent Years’ Pricing	 	 	 9	 
	     4.3
	 	Mid-Year Pricing	 	 	10	 
	     4.4
	 	Fee Adjustment Procedure	 	 	11	 
	     4.5
	 	Adjustments Due to Technical Changes	 	 	11	 
	     4.6
	 	Multi-Country Packaging Requirements	 	 	11	 
	 
	 	 	 	 	 	 
	ARTICLE 5. ORDERS, SHIPMENT, INVOICING, PAYMENT	 	 	12	 
	 
	 	 	 	 	 	 
	     5.1
	 	Orders and Forecasts	 	 	12	 
	     5.2
	 	Reliance by Patheon	 	 	12	 
	     5.3
	 	Minimum Orders	 	 	13	 
	     5.4
	 	Shipments	 	 	13	 
	     5.5
	 	Invoices and Payment	 	 	14	 
	 
	 	 	 	 	 	 
	ARTICLE 6. PRODUCT CLAIMS; RECALLS; ADVERSE EVENTS	 	 	15	 
	 
	 	 	 	 	 	 
	     6.1
	 	Product Claims	 	 	15	 
	     6.2
	 	Product Recalls and Returns	 	 	16	 
	     6.3
	 	Disposition of Defective or Recalled Products	 	 	17	 
	     6.4
	 	Customer Questions and Complaints	 	 	18	 
	     6.5
	 	Adverse Event Reporting	 	 	18	 
	 
	 	 	 	 	 	 
	ARTICLE 7. CO-OPERATION	 	 	18	 
	 
	 	 	 	 	 	 
	     7.1
	 	Quarterly Review	 	 	18	 
	     7.2
	 	Communication with Governmental Agencies	 	 	18	 
	     7.3
	 	Records and Accounting by Patheon	 	 	19	 

 

			
	***	 	Certain information on this page has been omitted and filed
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treatment has been requested with respect to the omitted portions.

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	     7.4
	 	Client’s Inspection of Reports and Records	 	 	19	 
	     7.5
	 	Client’s Access to Manufacturing Site	 	 	19	 
	     7.6
	 	Government Inspection	 	 	19	 
	     7.7
	 	Reports	 	 	20	 
	     7.8
	 	Validation and FDA Filings	 	 	20	 
	 
	 	 	 	 	 	 
	ARTICLE 8. TERM AND TERMINATION	 	 	22	 
	 
	 	 	 	 	 	 
	     8.1
	 	Initial Term	 	 	22	 
	     8.2
	 	Termination for Cause	 	 	22	 
	     8.3
	 	Product Partnering	 	 	22	 
	     8.4
	 	Product Discontinuation	 	 	23	 
	     8.5
	 	Obligations on Termination	 	 	23	 
	 
	 	 	 	 	 	 
	ARTICLE 9. REPRESENTATIONS, WARRANTIES AND COVENANTS	 	 	25	 
	 
	 	 	 	 	 	 
	     9.1
	 	Each Party	 	 	25	 
	     9.2
	 	Client Warranties	 	 	25	 
	     9.3
	 	Patheon Warranties	 	 	26	 
	     9.4
	 	Debarred Persons	 	 	27	 
	     9.5
	 	Permits	 	 	27	 
	     9.6
	 	Compliance with Laws	 	 	28	 
	     9.7
	 	No Other Warranty	 	 	28	 
	 
	 	 	 	 	 	 
	ARTICLE 10. REMEDIES AND INDEMNITIES	 	 	28	 
	 
	 	 	 	 	 	 
	     10.1
	 	Consequential Damages	 	 	28	 
	     10.2
	 	Limitation of Liability	 	 	28	 
	     10.3
	 	Patheon	 	 	29	 
	     10.4
	 	Client	 	 	30	 
	     10.5
	 	Indemnification Procedure	 	 	30	 
	 
	 	 	 	 	 	 
	ARTICLE 11. CONFIDENTIALITY	 	 	31	 
	 
	 	 	 	 	 	 
	     11.1
	 	Confidentiality	 	 	31	 
	     11.2
	 	Exceptions	 	 	32	 
	     11.3
	 	Authorized Disclosure	 	 	32	 
	     11.4
	 	Return of Confidential Information	 	 	33	 
	     11.5
	 	Equitable Relief	 	 	33	 
	 
	 	 	 	 	 	 
	ARTICLE 12. DISPUTE RESOLUTION	 	 	33	 
	 
	 	 	 	 	 	 
	     12.1
	 	Commercial Disputes	 	 	33	 
	     12.2
	 	Technical Dispute Resolution	 	 	34	 
	 
	 	 	 	 	 	 
	ARTICLE 13. MISCELLANEOUS	 	 	34	 
	 
	 	 	 	 	 	 
	     13.1
	 	Inventions	 	 	34	 
	     13.2
	 	Intellectual Property	 	 	35	 
	     13.3
	 	Insurance	 	 	35	 

- ii -

 

	 	 	 	 	 	 	 
	     13.4
	 	Independent Contractors	 	 	36	 
	     13.5
	 	Trademarks	 	 	36	 
	     13.6
	 	No Waiver	 	 	36	 
	     13.7
	 	Assignment	 	 	36	 
	     13.8
	 	Force Majeure	 	 	37	 
	     13.9
	 	Additional Product	 	 	37	 
	     13.10
	 	Notices	 	 	37	 
	     13.11
	 	Severability	 	 	38	 
	     13.12
	 	Entire Agreement	 	 	39	 
	     13.13
	 	Other Terms	 	 	39	 
	     13.14
	 	No Third Party Benefit or Right	 	 	39	 
	     13.15
	 	Execution in Counterparts	 	 	39	 
	     13.16
	 	Governing Law	 	 	39	 

- iii -

 

MANUFACTURING SERVICES AGREEMENT

          THIS
MANUFACTURING SERVICES AGREEMENT (the “Agreement”) made as of the 1st day of
February 2006.

B E T W E E N:

	 	 	 
	 

	 	PATHEON PHARMACEUTICALS INC.,
	 

	 	a corporation existing under the laws of Delaware,
	 
	 	 
	 

	 	(hereinafter referred to as “Patheon”),

- and -

	 	 	 
	 

	 	SOMAXON PHARMACEUTICALS, INC.,
	 

	 	a corporation existing under the laws of Delaware,
	 
	 	 
	 

	 	(hereinafter referred to as the “Client”).

          THIS AGREEMENT WITNESSES THAT in consideration of the rights conferred and the obligations
assumed herein, and for other good and valuable consideration (the receipt and sufficiency of which
are acknowledged by each party), and intending to be legally bound the parties agree as follows:

ARTICLE 1.

INTERPRETATION

1.1 Definitions. The following terms shall, unless the context otherwise requires,
have the respective meanings set out below and grammatical variations of such terms shall have
corresponding meanings:

“Act” means the Federal Food, Drug, and Cosmetic Act, together with any regulation
promulgated thereunder, including without limitation cGMPs, in each case as amended from
time to time;

“Active Materials” means the materials listed on Schedule E hereto;

“Active Materials Reimbursement Value” means the value attributable to the Active Materials
for certain purposes of this Agreement, as set forth in Schedule E hereto;

“ANDA” shall have the meaning ascribed thereto in Section 7.8(d);

 

 

“Adverse Experience” shall mean any side effect, injury, toxicity, sensitivity reaction,
unexpected incidence, untoward medical occurrence or other adverse event or experience
associated with the use of the Products, including, but not limited to, a “serious adverse
event” within the meaning of 21 C.F.R. § 314.80(a), as amended from time to time;

“Affiliate” means:

	 	(a)	 	a business entity which owns, directly or
indirectly, a controlling interest in a party to this Agreement, by
stock ownership or otherwise; or
	 
	 	(b)	 	a business entity which is controlled by a
party to this Agreement, either directly or indirectly, by stock
ownership or otherwise; or
	 
	 	(c)	 	a business entity, the controlling interest of
which is directly or indirectly common to the majority ownership of a
party to this Agreement;
	 
	 	(d)	 	For the purposes of this definition, “control”
means the ownership of shares carrying at least a majority of the votes
in respect of the election of the directors of a corporation;

“Agreement” shall have the meaning ascribed thereto in the preamble;

“Applicable Laws” means all Laws to the extent applicable to the subject matter of, or the
performance by the parties of their respective obligations under, this Agreement, including,
but not limited to, (i) with respect to Patheon, the Act and any other Laws of all
jurisdictions where the Products are manufactured, and (ii) with respect to Client, the Laws
of all jurisdictions where the Products are manufactured, distributed and marketed;

“Annual Report” means the annual report as described in 21 CFR, Section 314.81(b)(2);

“Annual Product Review Report” means the annual product review report as described in 21
CFR, Section 211.180(e);

“Authority” means any governmental or regulatory authority, department, body or agency or
any court, tribunal, bureau, commission or other similar body, whether federal, state,
provincial, county or municipal, including, but not limited to, the FDA;

“Broader Intellectual Property Rights” shall have the meaning ascribed thereto in Section
13.1(c);

- 2 -

 

“Business Day” means a day other than a Saturday, Sunday or a day that is a statutory
holiday in the State of Ohio or State of California;

“cGMPs” means current good manufacturing practices as described in Parts 210 and 211 of
Title 21 of the United States’ Code of Federal Regulations, together with the latest FDA
guidance documents pertaining to manufacturing and quality control practice, all as updated,
amended and revised from time to time, including, but not limited to, the FDA’s Guidance for
Industry, Manufacturing, Processing or Holding Active Pharmaceutical Ingredients;

“CMC” shall have the meaning ascribed thereto in Section 7.8(d);

“Certificate of Analysis” means (a) the certificate of analysis confirming the identity,
strength, quality and purity of each batch of finished Product to which it pertains;

“Client” shall have the meaning ascribed thereto in the preamble;

“Commencement Date” means the first day upon which the Manufacturing Services shall
commence;

“Components” means, collectively, all packaging components, raw materials and ingredients
(including labels, product inserts and other labeling for the Products), required to be used
in order to produce the Products in accordance with the Specifications, including the Active
Materials;

“Confidential Information” shall have the meaning ascribed thereto in Section 11.1;

“Deficiency Notice” shall have the meaning ascribed thereto in Section 6.1(a);

“Disclosing Party” shall have the meaning ascribed thereto in Section 11.1;

“FCA” means free carrier, as that term is defined in INCOTERMS 2000 published by the
International Chamber of Commerce;

“FDA” means the United States government agency known as the United States Food and Drug
Administration, and any successor thereto;

“Firm Orders” has the meaning specified in Section 5.1(b);

“Force Majeure Event” shall have the meaning ascribed thereto in Section 13.8;

“Indemnitor” shall have the meaning ascribed thereto in Section 10.5(a);

- 3 -

 

“Indemnitee” shall have the meaning ascribed thereto in Section 10.5(a);

“Initial Term” shall have the meaning ascribed thereto in Section 8.1;

“Intellectual Property” includes, without limitation, rights in patents, patent
applications, formulae, trade-marks, trade-mark applications, trade-names, Inventions,
copyright and industrial designs;

“Invention” means information relating to any invention, innovation, improvement,
development, discovery, computer program, device, trade secret, method, know-how, process,
technique or the like, whether or not written or otherwise fixed in any form or medium,
regardless of the media on which it is contained and whether or not patentable or
copyrightable;

“Inventory” means all inventories of Components and work-in-process produced or held by
Patheon or its Affiliates in connection with the manufacture of the Products, including, but
not limited to, the Active Materials;

“Late Shipment” shall have the meaning ascribed thereto in Section 6.1(d);

“Laws” means all laws, statutes, ordinances, regulations, rules, by-laws, judgments, decrees
or orders of any Authority, including, but not limited to, the Act and cGMPs;

“Manufacturing Services” means the manufacturing, quality control, quality assurance and
stability testing, packaging and related activities of Patheon, as contemplated in this
Agreement, required to produce Products from Active Materials and Components;

“Manufacturing Site” means the facility owned and operated by Patheon that is located at
2110 East Galbraith Road, Cincinnati, Ohio, USA 45237;

“Minimum Run Quantity” means the minimum number of batches, bottles or blisters of a Product
to be produced during the same cycle of manufacturing as set forth in Schedule C hereto;

“NDA” shall have the meaning ascribed thereto in Section 7.8(d);

“Patheon” shall have the meaning ascribed thereto in the preamble;

“Patheon Manufacturing Responsibilities” means Patheon’s responsibilities and obligations
with respect to the provision of Manufacturing Services as set forth in Section 2.2;

- 4 -

 

“Process Specifications” means clauses (a), (b), (c) and (d) of the definition of
Specifications;

“Products” means the products listed on Schedule A hereto;

“Product Claims” shall have the meaning ascribed thereto in Section 10.2;

“Product Quality Complaint” is defined as any complaint that questions the purity, identity,
potency or quality of the Product, its packaging, or labeling, or any complaint that
concerns any incident that causes the Product or its labeling to be mistaken for, or
applied to, another article or any bacteriological contamination, or any significant
chemical, physical, or other change or deterioration in the distributed Product, or any
failure of one or more distributed batches of the Product to meet the Specifications
therefor.

“Quality Agreement” means the agreement entered into between the parties hereto setting out
the quality assurance standards to be applicable to the Manufacturing Services provided by
Patheon, attached hereto as Schedule H;

“Recall” shall have the meaning ascribed thereto in Section 6.2(a);

“Receiving Party” shall have the meaning ascribed thereto in Section 11.1;

“Short Shipment” shall have the meaning ascribed thereto in Section 6.1(d);

“Specifications” means the file, for each Product, which is approved by the Client in
accordance with the procedures listed in Schedule B hereto and which contains documents
relating to such Product, including, without limitation:

	 	(a)	 	specifications for Active Materials and Components;
	 
	 	(b)	 	manufacturing specifications, directions and processes;
	 
	 	(c)	 	storage requirements;
	 
	 	(d)	 	all environmental, health and safety information relating to the Product
including material safety data sheets;
	 
	 	(e)	 	the finished Product specifications, packaging specifications and shipping
requirements for each Product, including, but not limited to, any requirements set
forth in the applicable regulatory filings made with the FDA or other Authority (e.g.,
the NDA and/or ANDA) and provided by Client to Patheon;

- 5 -

 

all as updated, amended and revised from time to time by the Client in accordance with the
terms of this Agreement;

“Technical Dispute” has the meaning specified in Section 12.2;

“Territory” shall mean (i) [***] and (ii) any additional country(ies) and/or commonwealths,
territories and possessions which the Client may later designate in its sole discretion in
an addendum to this Agreement; provided that the Client shall bear all incremental costs,
including, but not limited to labeling costs, associated with the manufacture of the Product
for such additional country(ies) and/or commonwealths, territories and possessions in
amounts to be agreed by the parties;

“Third Party Rights” means the Intellectual Property of any third party;

“Year” means a calendar year, except that the first “Year” of this Agreement shall be deemed
to be the period from the Commencement Date up to and including December 31, 2007;

1.2 Currency. Unless otherwise indicated, all monetary amounts are expressed in this
Agreement in the lawful currency of the United States of America.

1.3 Sections and Headings. 

          The division of this Agreement into Articles, Sections, subsections and Schedules and the
insertion of headings are for convenience of reference only and shall not affect the interpretation
of this Agreement. Unless otherwise indicated, any reference in this Agreement to a Section or
Schedule refers to the specified Section or Schedule to this Agreement. In this Agreement, the
terms “this Agreement”, “hereof”, “herein”, “hereunder” and similar
expressions refer to this Agreement and not to any particular part, Section, Schedule or the
provision hereof.

1.4 Singular Terms.

          Except as otherwise expressly provided herein or unless the context otherwise requires, all
references to the singular shall include the plural and vice versa.

1.5 Schedules.

          The following Schedules are attached to, incorporated in and form part of this Agreement:

	 	 	 	 	 	 	 
	 

	 	Schedule A
	 	-
	 	Products
	 

	 	Schedule B
	 	-
	 	Procedure for Shipment & Acceptance of Product Specifications

 

			
	***	 	Certain information on this page has been omitted and filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.

- 6 -

 

	 	 	 	 	 	 	 
	 

	 	Schedule C
	 	-
	 	Minimum Run Quantity, Annual Volume & Fees
	 

	 	Schedule D
	 	-
	 	Stability Testing
	 

	 	Schedule E
	 	-
	 	Active Materials & Active Materials Reimbursement Value
	 

	 	Schedule F
	 	-
	 	Batch Numbering & Expiration Dates
	 

	 	Schedule G
	 	-
	 	Technical Dispute Resolution
	 

	 	Schedule H
	 	-
	 	Quality Agreement
	 

	 	Schedule I
	 	-
	 	Product Bill of Materials

ARTICLE 2.

PATHEON’S MANUFACTURING SERVICES

2.1 Manufacturing Services.

          During the term of this Agreement, Patheon shall manufacture and supply, in accordance with
the provisions of this Agreement, all quantities of the Products ordered by the
Client consistent with Article 5, and shall provide such Manufacturing Services for the
Territory for the fees specified in Schedules C and D. The Client shall purchase at least (i)
[***]% of its requirement of Products of between [***] tablets per Year; and (ii) [***]% of its
requirement of Products of greater than [***] tablets per Year for sale in the Territory from
Patheon pursuant to the terms of this Agreement; provided, however, that such purchase requirements
shall be prorated for the first Year to the extent the first Year is less than a complete calendar
year. In providing the Manufacturing Services, the Client and Patheon agree that:

          (a) Conversion of Active Materials and Components. Patheon shall convert Active
Materials and Components into Products.

          (b) Quality Control and Quality Assurance. Patheon shall perform the quality control
and quality assurance testing specified in the Quality Agreement. Each time Patheon ships Products
to the Client, it shall provide the Client with a Certificate of Analysis that sets out the test
results for each batch of Products, and that certifies that such batch has been evaluated by
Patheon’s Quality Control/Quality Assurance department and that the Products comply with the
Specifications.

          (c) Components. Patheon shall purchase and test all Components (with the exception of
those that are supplied by the Client) at Patheon’s expense and as specified by the Specifications.

          (d) Active Materials. [***] shall purchase the Active Materials in sufficient
quantities and at such times as may be necessary to provide the Manufacturing Services by Patheon
hereunder. [***] shall bear the risk of loss of the Active Materials while in transit from the
supplier and thereafter until incorporated into Products and deemed shipped to the Client

 

			
	***	 	Certain information on this page has been omitted and filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.

- 7 -

 

under Section 5.4. Patheon shall test the Active Materials at [***] expense and as specified by the
Specifications.

          (e) Stability Testing. Patheon shall conduct stability testing on the Products in
accordance with the protocols set out in the Specifications for the separate fees specified in
Schedule D. Patheon shall not make any changes to these testing protocols without prior
written approval from the Client. In the event that any batch of Products fails stability testing,
(i) Patheon shall investigate and confirm that all analytical methods have been properly applied
and, if applicable, corrected, and (ii) Patheon and the Client shall jointly determine the
proceedings and methods to be undertaken to investigate the causes of such failure, including which
party shall bear the cost of such investigation, provided that, subject to Section 10.2, Patheon
shall be liable for such costs if the failure is attributable to Patheon’s failure to provide the
Manufacturing Services in accordance with the Specifications or cGMPs. Patheon will provide any
and all data and results relating to the stability testing upon request by the Client.

          (f) Packaging. Patheon shall package the Products with labels, product inserts and
other packaging as set out in the Specifications. The Client shall be responsible for the cost of
artwork development. In addition, Patheon shall make arrangements for and implement the imprinting
of batch numbers and expiration dates for each Product shipped. Such batch numbers and expiration
dates shall be affixed on the Products and on the shipping carton of each Product as outlined in
the Specifications and as required by cGMPs. The system used by Patheon for batch numbering and
expiration dates is detailed in Schedule F hereto. The Client may, in its sole discretion, make
changes to labels, product inserts and other packaging for the Products, which changes shall be
submitted by the Client to all applicable Agencies and other third parties responsible for the
approval of the Products. The Client shall be responsible for the cost of labeling obsolescence
when changes occur. Patheon’s name shall not appear on the label or anywhere else on the Products
unless: (i) required by any Laws; or (ii) Patheon and the Client expressly consent to such use of
Patheon’s name in writing.

          (g) Storage. Until finished Products are shipped, Patheon shall store all such
Products identifiably distinct from any other raw material and finished or filled product stocks
and shall comply with all storage requirements set forth in the Specifications and all Applicable
Laws, including, but not limited to, cGMPs. Patheon shall assume responsibility for any loss or
damage to such finished Product while stored by Patheon.

          (h) Facility. Patheon will manufacture, test, perform quality control and package the
Product at the Manufacturing Site. Patheon shall not manufacture, test, perform quality control or
package any Product in any other facility without first obtaining the Client’s prior written
consent.

          (i) Product Rejection for Process Failure. The parties acknowledge that at the time
of execution of this Agreement the Product is in development. Prior to packaging any bulk

 
 

			
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finished Product, Patheon shall test each batch of bulk finished Product for compliance with the finished
Product Specifications (excluding packaging-related specifications). In the event any
nonconforming Product is observed in connection with such testing procedures, Patheon shall
promptly suspend the packaging of the applicable batch, notify Client in writing, and consult with
Client with respect to available alternatives.

          If Patheon manufactures Products in accordance with the Process Specifications and a batch or
portion of a batch does not meet a finished Product Specification, [***] shall [***] for its [***],
any [***], and any [***].

2.2 Standard of Performance.

          Patheon shall provide the Manufacturing Services in accordance with the Specifications, cGMPs
and Applicable Laws.

ARTICLE 3.

CLIENT’S OBLIGATIONS

3.1 Payment.

          Pursuant to the terms of this Agreement, the Client shall pay Patheon for the provision of the
Manufacturing Services according to the fees specified in Schedules C and D hereto (such fees being
subject to adjustment in accordance with the terms hereof).

ARTICLE 4.

CONVERSION FEES AND COMPONENT COSTS

4.1 [***] Pricing.

          The fees for the Manufacturing Services (including Component costs) for the [***] are listed
in Schedules C and D and the fees for the Manufacturing Services ([***]) are intended by the
parties to be [***] for the [***] of this Agreement, subject to the adjustments set forth in
Section 4.3.

4.2 Price Adjustments — Subsequent Years’ Pricing.

          The fees for the Manufacturing Services provided pursuant to the terms of this Agreement for
any Year beginning after the [***] Year under this Agreement shall be determined in accordance with
the following:

          (a) Manufacturing and Component Costs. At the [***] and [***] of this Agreement,
Patheon shall be entitled to request an adjustment to the fees (i) for Manufacturing Services in
respect of the Products to reflect inflation, which adjustment shall not exceed [***],

 

			
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unless the parties otherwise agree in writing; and (ii) for Component costs to [***] any increase or decrease
in such costs; provided, however, that in the event any proposed increase in the cost of a
Component exceeds [***]% of the cost for that Component upon which the most recent fee quote was
based, Patheon shall use its commercially reasonable efforts to locate an equivalent alternative
lower cost supplier for the applicable Component. Notwithstanding the foregoing, to the extent
costs for Components decrease in the [***] or any [***] of this Agreement, Patheon shall pass on to
the Client [***] of any decrease in such costs.

          (b) Pricing Basis. The Client acknowledges that the fee for Manufacturing Services in
respect of a Product in any Year is quoted based upon the Minimum Run Quantity per Product
specified in Schedule C and is subject to change if the specified Minimum Run Quantity is revised.
For greater certainty, if Patheon and the Client agree that the Minimum Run
Quantity in respect of a Product shall be increased or decreased and, as a result of such
increase or decrease, Patheon’s fees for services relating to such Product decrease or increase on
a per unit basis, then if such revised Minimum Run Quantity is not otherwise contemplated in
Schedule C, Patheon shall be entitled to a decrease or increase in the fee for Manufacturing
Services in respect of such Product by an amount sufficient to pass on to the Client the cost
savings or to absorb, but not exceed, such increased costs, as the case may be. When the volume
reaches the upper tiers contemplated in Schedule C, the Client will need to select which option
Patheon is to follow, i.e. small batch size and two (2) batches per campaign or one (1) large batch
per campaign. Batch sizes will not be varied on an order by order basis.

4.3 Mid-Year Pricing

          During any Year of this Agreement, Patheon shall be entitled to request an adjustment to the
fees for Component costs (i) to pass on the actual amount of any increase or decrease in such
costs; and (ii) if at any time market conditions result in Patheon’s cost of Components being
materially greater than normal forecasted increases, then Patheon shall be entitled to request an
adjustment to the fee for Manufacturing Services in respect of any affected Product to compensate
it for such increased Component costs; provided, however, that in the event any proposed increase
in the cost of a Component exceeds [***]% of the cost for that Component upon which the most recent
fee quote was based, Patheon shall use its commercially reasonable efforts to locate an equivalent
alternative lower cost supplier for the applicable Component. For the purposes of this Section
4.3, changes materially greater than normal forecasted increases shall be considered to have
occurred if: (i) the cost of a Component increases by [***]% of the cost for that Component upon
which the most recent fee quote was based; or (ii) the aggregate cost for all Components required
to manufacture a Product increases by [***]% of the total Component costs for such Product upon
which the most recent fee quote was based. To the extent that Component costs have been previously
adjusted pursuant to clause (a) of Section 4.2 or this Section 4.3 to reflect an increase in the
cost of one or more Components, the adjustments provided for in (i) and (ii) above shall operate
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attributed to such Component (or Components) at the time the last of such adjustments were
made.

4.4 Fee Adjustment Procedure

          In connection with all fee adjustment requests pursuant to this Article 4, Patheon shall
deliver to the Client by not later than November 1st of each Year a revised Schedule C
in draft form and such budgetary pricing information or other documentation (including the [***] in
the case of any adjustment request pertaining to fees for Manufacturing Services and, the adjusted
Component costs) reasonably sufficient to demonstrate that a fee adjustment is justified. Upon
delivery of such a request, each of the Client and Patheon shall forthwith use all reasonable
efforts to agree on a revised fee for the Manufacturing Services in respect of each affected
Product and Schedule C shall be amended accordingly. Such revised fee shall be effective with
respect to any Product delivered after the end of the then current Year.

4.5 Adjustments Due to Technical Changes.

          Amendments to the Specifications or the Quality Agreement requested by the Client will only be
implemented following a technical and cost review by Patheon and are subject to the Client and
Patheon reaching agreement as to revisions, if any, to the fees specified in Schedules C or D
necessitated by any such amendment. If the Client accepts a proposed fee change, the proposed
change in the Specifications shall be implemented, and the fee change shall become effective only
with respect to those orders of Products that are manufactured in accordance with the revised
Specifications. In addition, the Client agrees to purchase, at Patheon’s cost therefor (including
all costs incurred by Patheon in connection with the purchase and handling of such Inventory), all
Inventory utilized under the “old” Specifications and purchased or maintained by Patheon in order
to fill Firm Orders or in accordance with Section 5.2, to the extent that such Inventory can no
longer be utilized under the revised Specifications. Open purchase orders for Components no longer
required under any revised Specifications that were placed by Patheon with suppliers in order to
fill Firm Orders or in accordance with Section 5.2 shall be
cancelled where possible, and where such orders are not subject to cancellation
without penalty, shall be assigned to and satisfied by the Client.

4.6 Multi-Country Packaging Requirements. 

          If and when the Client decides that it wishes to have Patheon manufacture the Product for
countries in the Territory in addition to [***], then the Client shall inform Patheon of the
packaging requirements for each new country and Patheon shall prepare a quotation for consideration
by the Client of the additional Component costs, if any, and the change over fees for the Product
destined for such new country. The agreed additional packaging requirements and related packaging
costs and change over fees shall be set out in a written amendment to this Agreement.

 

			
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ARTICLE 5.

ORDERS, SHIPMENT, INVOICING, PAYMENT

5.1 Orders and Forecasts. 

          (a) Rolling Forecasts. Concurrent with the execution of this Agreement, the Client
shall provide Patheon with a written non-binding 12 month forecast of the volume of each Product
that the Client then anticipates will be required to be produced and delivered to the Client during
each month of the 12 month period thereafter. Such forecast will be updated by the Client monthly
on or before the 10th day of the month on a rolling 12 month basis and updated promptly
after such time as the Client determines that the volumes contemplated in the most recent of such
forecasts has changed by more than [***]%. The most recent 12 month forecast shall supersede all
previous forecasts.

          (b) Firm Orders. On or before the 20th day of each calendar month, the Client shall
issue firm written orders (“Firm Orders”) for the Products to be produced and delivered to the
Client on a date not less than 90 days from the first day of the calendar month immediately
following the date that the Firm Order is submitted. Such Firm Orders submitted to Patheon
shall specify the Client’s purchase order number, quantities by Product type, monthly delivery
schedule and any other elements necessary to ensure the timely production and shipment of the
Products. The quantities of Products ordered in such Firm Orders shall be firm and binding on the
Client and shall not be subject to reduction by the Client. Firm Orders submitted by the Client
pursuant to this Section 5.1 must be accepted by Patheon and shall be automatically firm and
binding on Patheon if they are not more than [***]% of the amount most recently forecast for the
delivery period specified in the Firm Order. Patheon will use commercially reasonable efforts to
manufacture Product in excess of [***]% of the amount most recently forecast for the delivery
period specified in the Firm Order. Firm Orders not rejected by Patheon within three Business Days
of receipt by Patheon shall be deemed to have been accepted by Patheon.

          (c) Three Year Forecast. On or before the 1st day of November of each
Year commencing not later than six months prior to the anticipated Commencement Date (as estimated
in the Client’s reasonable judgment based on clinical development timelines and regulatory
activities), the Client shall provide Patheon with a written non-binding three-year forecast
(broken down by quarters for the second and third years of the forecast) of the volume of each
Product the Client then anticipates will be required to be produced and delivered to the Client
during the three-year period, and updated on or before the 1st day of May in each Year.

5.2 Reliance by Patheon.

     The Client understands and acknowledges that Patheon will rely on the first [***] months
contemplated in the most recent forecast provided by the Client pursuant to Section 5.1(a) and the
Firm Orders submitted pursuant to Section 5.1(b) in ordering the Components

 

			
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required to meet such Firm Orders. In addition, the Client understands that to ensure an orderly supply of such
Components, it may be desirable for Patheon to purchase such Components in sufficient volumes to
meet the production requirements for Products during part or all of the forecasted periods referred
to in Section 5.1(a) or to meet the production requirements of any longer period agreed to by
Patheon and the Client. Accordingly, the Client authorizes Patheon to purchase Components in order
to satisfy the production requirements for Products for the first [***] months contemplated in the
most recent forecast provided by the Client pursuant to Section
5.1(a) and agrees that Patheon may make such other purchases of Components to meet production
requirements during such longer periods as may be agreed to in writing from time to time by the
Client at the request of Patheon or the Client. The Client shall provide Patheon with its written
authorization to order Components in respect of any launch quantities of Product requested by the
Client, which upon acceptance by Patheon shall constitute a Firm Order. If Components ordered by
Patheon pursuant to Firm Orders or in order to satisfy the production requirements for Products for
the first [***] months contemplated in the most recent forecast provided by the Client pursuant to
Section 5.1(a) are not included in finished Products purchased by the Client within [***] months
after the forecasted month in respect of which such purchases have been made (or such longer period
as the parties may agree), then Patheon shall promptly notify Client and the Client shall pay to
Patheon [***]; provided, however, that (i) the Client shall have the option but not the obligation
to take title to and possession of all or any portion of such Components by written notice to
Patheon, in which case Patheon shall cooperate with the Client in the surrender, delivery and
transfer of such Components as promptly as is commercially reasonable, with any shipping and
related expenses to be borne by the Client, or (ii) in the event such Components are incorporated
into Products subsequently purchased by the Client or into third party products manufactured by
Patheon and subsequently purchased by a third party, the Client will receive credit for any costs
of such Components previously paid to Patheon by the Client. Patheon shall not be obligated to
provide information regarding any Component which is subject to confidentiality obligations between
Patheon and its supplier.

5.3 Minimum Orders.

          The Client may only order Products in multiples of the Minimum Run Quantities set out in
Schedule C.

5.4 Shipments.

          Shipments of Products shall be made FCA the Manufacturing Site unless otherwise mutually
agreed in writing and Patheon shall make every reasonable effort to ship finished goods within
[***] months of the start of manufacture of the Products unless otherwise
agreed upon in writing by both parties. Failure to ship within [***] months is not a cause
for refusal of Product. Notwithstanding the foregoing, if FDA approves the Products for [***]
months of shelf life, the Products must carry at least [***] months of shelf life when shipped.

 

			
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Risk of loss or of damage to Products shall remain with Patheon until Products are loaded onto the
carrier’s vehicle by Patheon for shipment at the shipping point at which time risk of loss or
damage shall transfer to the Client. Patheon shall, in accordance with the Client’s instructions
and as agent for the Client, (i) arrange for shipping, including preparing and executing a packing
list, so that the Product will be delivered to the delivery address on the delivery date set forth
in the applicable Firm Order, with such shipping to be paid by the Client and (ii) at the Client’s
risk and expense, obtain any export license or other official authorization necessary to export the
Products, including all customs formalities. The Client shall arrange for insurance and shall
select the freight carrier used by Patheon to ship Products and may monitor Patheon’s shipping and
freight practices as they pertain to this Agreement. Patheon shall notify Client in writing at the
time of shipment as to the quantity of Product shipped, the anticipated delivery date and
confirmation of the carrier. If any order is delayed and is not likely to be delivered to the
carrier on time, Patheon shall immediately notify Client and Client may reasonably direct Patheon
to ship such order by expedited means of transportation as designated by Client, at [***] expense.
If the delay of any order results in substantial back orders to the Client and Patheon caused the
delay, [***] shall pay the reasonable additional cost for the expedited transport. In all cases,
Products shall be transported in accordance with the Specifications and Applicable Laws, including,
but not limited to, cGMPs.

5.5 Invoices and Payment.

          (a) Invoices. Invoices for Products that are shipped to Client shall be sent by fax
or email to such fax number or email address as may be provided by the Client in writing from time
to time, but not earlier than the date of shipment of the corresponding Products. Patheon shall
also submit to the Client, with each shipment of Products, a duplicate copy of the invoice covering
such shipment. Patheon shall also provide the Client with an invoice covering any Inventory or
Components which are to be purchased by Patheon pursuant to Section 5.2
hereof. Each such invoice shall, to the extent applicable, identify the Client purchase order
number, Product numbers, names and quantities, unit price, freight charges and the total amount to
be remitted by the Client.

          (b) Payment. The Client shall pay undisputed amounts of all invoices within [***]
days of the date of postmark or confirmed facsimile or email transmission of the invoice.

          (c) Disputed Amounts. In the event that the Client disputes any amounts under any
invoice for Products, such dispute shall be resolved in accordance with Section 6.1 (with respect
to non-conformance of Products) or otherwise under Article 12. Pending resolution of such dispute,
the Client shall be obligated to pay any amounts under such invoice that are not in dispute. Upon
resolution of any such dispute in favor of Patheon, the Client shall pay all remaining amounts
owing under such invoice within the later of (i) [***] Business days after such resolution or (ii)
[***] days after the date of such invoice.

 

			
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ARTICLE 6.

PRODUCT CLAIMS; RECALLS; ADVERSE EVENTS

6.1 Product Claims.

          (a) Product Claims. The Client has the right to reject and return, at the expense of
Patheon, all or any portion of any shipment of Products that deviates from the Specifications or
cGMPs, without invalidating any remainder of such shipment. The Client or its designated agent
shall inspect the Products manufactured by Patheon upon receipt of such Products and related
Certificate(s) of Analysis and shall give Patheon written notice (a “Deficiency Notice”) of all
claims for Products that deviate from the Specifications or cGMPs within 30 days after the Client’s
receipt of such Products and related Certificate(s) of Analysis (or, in the case of any defects not
reasonably susceptible to discovery upon receipt of the Product, within 30 days after discovery
thereof by the Client, but in no event after the expiration date of the Product). Should the
Client fail to provide Patheon with the Deficiency Notice within the applicable 30-day period, then
the delivery shall be deemed to have been accepted by the
Client on the 30th day after delivery or discovery, as applicable. Except as set
out in Section 6.2, Patheon shall have no liability for any deviations for which Client has failed
to provide notice within the applicable 30-day period.

          (b) Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall
have 10 days to advise the Client by notice in writing that it disagrees with the contents of such
Deficiency Notice. If the Client and Patheon fail to agree within 10 days after Patheon’s notice
to the Client as to whether any Products identified in the Deficiency Notice deviate from the
Specifications or cGMPs, then the parties shall mutually select an independent laboratory within
five days from the parties’ failure to agree, which independent laboratory shall evaluate if the
Products deviate from the Specifications or cGMPs. The parties shall cause the independent
laboratory to conduct its evaluation as promptly as practicable, and in any event within 30 days
from the date of selection of the laboratory. Such evaluation shall be binding on the parties, and
if such evaluation certifies that any Products deviate from the Specifications or cGMPs, the Client
may reject those Products in the manner contemplated in this Section 6.1. If such evaluation does
not so certify in respect of any such Products, then the Client shall be deemed to have accepted
delivery of such Products on the date the evaluation is delivered by the independent laboratory to
the parties. The expenses of such testing shall be borne by Patheon if the non-conformity with the
Specifications or cGMPs is confirmed by the independent laboratory, and otherwise by the Client.

          (c) Patheon Responsibility. In the event the Client rejects Products in accordance
with this Section 6.1 and the deviation is determined to arise from Patheon’s failure to provide
the Manufacturing Services in accordance with the Specifications or cGMPs, Patheon will, at the
Client’s election, either: (i) credit the Client’s account for Patheon’s invoice price to

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the Client for such defective Products or (ii) use its commercially reasonable efforts to replace such
Products with conforming Products within [***] days’ of the Client’s rejection of the
non-conforming Products; provided, however, that Patheon shall [***]. If the Client shall have
previously paid for such defective Products, Patheon shall, at the Client’s election, either: (i)
refund the invoice price for such defective Products within [***] days’ of the Client’s rejection
of the non-conforming Products; (ii) offset such amount against other amounts due to Patheon
hereunder; or (iii) use its commercially reasonable efforts to replace such Products with
conforming Products within [***] days’ of the Client’s rejection of the non-conforming Products
without the Client being liable for payment therefor under Section 3.1. In connection with the
production of any replacement Products under this Section 6.1(c), Patheon’s cost for the
procurement of any additional [***] required for the manufacture of such replacement Products shall
be limited to the [***]. Nothing in this Section 6.1 shall be construed to limit the rights and
remedies available to the Client at law or in equity.

          (d) Shortages. Claims for shortages in the amount of Products shipped by Patheon
shall be dealt with as may reasonably be agreed to by the parties. If a shipment of Products,
however, contains less than [***] % of the minimum yield performance (as defined in the final
Specifications and mutually agreed to by the parties) of the quantity specified in the
corresponding Firm Order (the “Shortage Amount”), the Client shall notify Patheon promptly upon
such discovery and, in any event, not later than 10 days after receipt of the shipment. Upon
receipt of Client’s written request, Patheon shall use commercially reasonable efforts, subject to
the availability of Active Materials and Components, to manufacture and ship the Shortage Amount
within [***] days provided, however, that Patheon shall [***]. In the event that the Shortage
Amount is less than a validated batch size as set forth in Schedule C, then Patheon shall
manufacture the next highest validated batch size of the Product (“Shortage Batch”) and package the
Shortage Batch, including the Shortage Amount, in accord with the Client’s written instructions.
Nothing in this Section 6.1 shall be construed to limit the rights and remedies available to the
Client at law or in equity.

6.2 Product Recalls and Returns.

          (a) Records and Notice. Patheon and the Client shall each maintain such records as
may be necessary to permit a Recall of any Products delivered to the Client or customers of the
Client. Each party shall promptly notify the other by telephone (to be confirmed in writing) of
any information which might affect the marketability, safety or effectiveness of the Products
and/or which might result in the Recall or seizure of the Products.
Upon receiving any such notice or upon any such discovery, each party shall cease and desist
from further shipments of such Products in its possession or control until a decision has been made
whether a Recall or some other corrective action is necessary. The decision to initiate a Recall
or to take some other corrective action, if any, shall be made and implemented by the Client.
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quantities of the Products sold or shipped to third parties (including, without limitation, the voluntary
withdrawal of Products from the market); or (ii) by any regulatory authorities to detain or destroy
any of the Products. Recall shall also include any action by either party to refrain from selling
or shipping quantities of the Products to third parties which would have been subject to a Recall
if sold or shipped.

          (b) Recalls. In the event (i) any Authority issues a directive, order or, following
the issuance of a safety warning or alert with respect to a Product, a written request that any
Product be Recalled, (ii) a court of competent jurisdiction orders such a Recall, or (iii) the
Client determines that any Product should be Recalled or that a “dear doctor” letter is required
relating the restrictions on the use of any Product, Patheon will co-operate as reasonably
requested by the Client, having regard to all Applicable Laws.

          (c) Product Returns. The Client shall have the responsibility for handling customer
returns of the Products. Patheon shall provide the Client with such assistance as the Client may
reasonably request to handle such returns.

          (d) Patheon’s Responsibility. To the extent that a Recall or return results from, or
arises out of, a failure by Patheon to provide the Manufacturing Services in accordance with the
Specifications or cGMPs, Patheon shall be responsible for the documented out-of-pocket expenses of
such Recall or return and shall promptly, at the Client’s election, either: (i) refund the invoice
price for such Recalled or returned Products; (ii) offset such amount against other amounts due to
Patheon hereunder; or (iii) use its commercially reasonable efforts to replace such Recalled or
returned Products with conforming Products within [***] days’ of the Client’s election under this
clause (d) without the Client being liable for payment therefor under Section 3.1; provided,
however, that Patheon shall [***]. In all other circumstances, Recalls,
returns or other corrective actions shall be made at the Client’s direction and cost and
expense. In connection with the production of any replacement Products under this clause (d),
Patheon’s cost for the procurement of any additional [***] required for the manufacture of such
replacement Products shall be limited to the [***].

6.3 Disposition of Defective or Recalled Products.

          The Client shall not dispose of any damaged, defective, returned or Recalled Products in
relation to which it intends to assert a claim against Patheon unless it has given Patheon 60 days’
notice of its intention to do so, and Patheon has not, in turn, instructed the Client to return
such Products to Patheon. Patheon shall bear the cost of shipping, storage and disposition with
respect to any damaged, defective, returned or Recalled Products in relation to which it bears
responsibility under Section 6.1 or 6.2 hereof, and shall promptly reimburse Client for any such
costs which may be incurred directly by the Client. In all other circumstances, the Client shall
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Recalled Products. Notwithstanding the foregoing, the Client shall have the right at all times to retain a reasonable
sample of such Products for its own archival purposes.

6.4 Customer Questions and Complaints.

          The Client shall have the sole responsibility for responding to Product Quality Complaints,
subject to Patheon’s obligation of cooperation and expense reimbursement set forth below. Product
Quality Complaints received by Patheon from the Client’s customers shall be referred to the Client
within two Business Days from the receipt thereof by Patheon.

6.5 Adverse Event Reporting.

          Patheon shall notify the Client promptly and not later than 24 hours after it becomes aware of
any Adverse Experience associated with the use of the Products, whether or not determined to be
attributable to the Products, and whether or not deemed to be serious or non-serious. Such
information shall be sent to the Client as set forth in the Quality Agreement.

          If the cause of any Adverse Experience results from a failure by Patheon to provide the
Manufacturing Services in accordance with the Specifications or cGMPs, Patheon shall bear all costs
incurred in respect of this Section 6.5. In all other circumstances, such costs shall be borne by
the Client.

ARTICLE 7.

CO-OPERATION

7.1 Quarterly Review.

          Each party shall forthwith upon execution of this Agreement appoint one of its employees to be
a relationship manager responsible for liaison between the parties. The relationship managers
shall meet not less than quarterly to review the current status of the business relationship and
manage any issues that have arisen.

7.2 Communication with Governmental Agencies.

          The Client shall be primarily responsible for communicating with any Authority regarding such
Products, including, but not limited to, the FDA and any other Authority responsible for granting
regulatory approval for the Products; provided, however, that if in the opinion of Patheon’s
counsel, Patheon must communicate with an Authority to comply with the terms of this Agreement or
the requirements of any Applicable Laws, it may do so. Unless, in the reasonable opinion of its
counsel, there is a legal prohibition against doing so, each party shall permit the other party to
accompany and take part in any communications with any Authority, and to receive copies of all such
communications from any Authority.

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7.3 Records and Accounting by Patheon.

          Patheon shall keep records of the manufacture, testing and shipping of the Products, Active
Materials and Components and retain samples of such Products, Active Materials and Components as
are necessary to comply with all Applicable Laws, including, but
not limited to, cGMPs and other manufacturing regulatory requirements applicable to Patheon,
the Manufacturing Site, the Products, the Active Materials and/or the Components, as well as to
assist with resolving Product complaints and other similar investigations. Copies of such records
and samples shall be retained for a period of one year following the date of Product expiry, or
longer if required by Applicable Laws after which Patheon may destroy such records or samples;
provided that Patheon has first given the Client 60 days notice of its intention to do so and the
Client has not, in turn, instructed Patheon to ship such records or samples to the Client at the
Client’s expense.

7.4 Client’s Inspection of Reports and Records.

          The Client may inspect Patheon reports and records relating to this Agreement during normal
business hours and with reasonable advance notice, provided a Patheon representative is present
during any such inspection.

7.5 Client’s Access to Manufacturing Site.

          Patheon shall provide the Client with reasonable access at mutually agreeable times to its
Manufacturing Site or any other facilities in which the Products are manufactured, stored, handled
or shipped in order to permit the Client’s verification of Patheon’s compliance with the Patheon
Manufacturing Responsibilities and with all Applicable Laws. For greater certainty, the right of
access provided in this Section 7.5 shall not include a right to access or inspect Patheon’s
financial records.

7.6 Government Inspection.

          Patheon shall make its internal practices, books and records relating to the manufacture of
the Products available and allow access to all facilities used for manufacturing the Products to
the FDA and any other Authority having jurisdiction over the manufacture of the Products for the
purposes of determining Patheon’s compliance with Applicable Laws, including, but not limited to,
cGMPs. Patheon shall advise the Client by telephone and facsimile
within one Business Day of any proposed or announced visit, audit or inspection, and as soon
as possible (but in any case within two Business Days) after any unannounced visit, audit or
inspection, by the FDA or any other Authority relating to the Products. Patheon shall provide the
Client with a reasonable description in writing of each such visit or inspection promptly (but in
no event later than five calendar days) thereafter, and with copies of any Authority-issued
inspection observation reports (including, without limitation, FDA Form 483s and equivalent

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forms from other regulatory bodies) and Authority correspondence, purged only of confidential information
that is unrelated to the Products. Patheon and the Client will cooperate in resolving any concerns
with any Authority, and the Client may review Patheon’s responses to any such reports and
communications, and Patheon shall in its reasonable discretion incorporate into such responses any
comments received from the Client. Patheon will also inform the Client of any action taken by any
Authority against Patheon or any of its officers or employees which may be reasonably expected to
adversely affect the Products or Patheon’s ability to supply the Products hereunder within two
Business Days after the action is taken.

7.7 Reports.

          Patheon will supply on an annual basis all Product data in its control, including release test
results, complaint test results and all investigations (in manufacturing, testing and storage),
that the Client reasonably requires in order to complete any filing under any applicable regulatory
regime, including any Annual Report that the Client is required to file with the FDA. At the
Client’s request Patheon shall provide a copy of the Annual Product Review Report to the Client
[***]. Any additional report requested by Client beyond the scope of cGMPs and customary FDA
requirements shall [***].

7.8 Validation and FDA Filings

          (a) Validation. Patheon will validate all applicable processes, methods, equipment,
utilities, facilities and computers used in the manufacture, packaging, storage, testing and
release of Products in conformance with all Applicable Laws, including, but not limited to,
cGMPs. Upon request, Patheon shall provide to Client a copy of the results of Product specific
validation when such results are available.

          (b) FDA Filings. The Client shall have the sole responsibility for filing all
documents with the FDA and taking any other actions that may be required for the receipt of FDA
Approval for the commercial manufacture of all of the Products. Patheon shall assist the Client,
to the extent consistent with Patheon’s obligations under this Agreement, including, but not
limited to, the obligations under clause (a) of this Section 7.8 above, to obtain FDA Approval for
the commercial manufacture of all Products as quickly as reasonably possible. Copies of all
relevant CMC (as hereinafter defined) submissions and any related FDA correspondence are to be
provided to Patheon by the Client.

          (c) Verification of Data. At least 14 days prior to filing any documents with the FDA
that incorporate data generated by Patheon, the Client shall provide Patheon with a copy of the
documents incorporating such data so as to give Patheon the opportunity to verify the accuracy and
regulatory validity of such documents as they relate to the Patheon generated data.

 

			
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          (d) Verification of CMC. At least 14 days prior to filing with the FDA the Chemistry
and Manufacturing Controls (“CMC”) of the New Drug Application (“NDA”) or the Abbreviated New Drug
Application (“ANDA”) filing, as the case may be, the Client shall provide Patheon with a copy of
the CMC portion as well as any supporting documents which have been relied upon to prepare the CMC
portion so as to permit Patheon to verify that the CMC portion accurately describes the work that
Patheon has performed and the manufacturing processes that Patheon will perform pursuant to this
Agreement. Notwithstanding the foregoing, the Client may omit from the materials provided to
Patheon any CMC portion and supporting documents which have been previously provided by Patheon to
the Client and which have not been modified or edited by the Client.

          (e) Pre-Approval Inspection. If Client does not provide Patheon with the
documentation requested under paragraphs (c) and (d) above within the time stipulated in these
paragraphs and if Patheon reasonably believes that Patheon’s standing with the FDA may be
jeopardized, [***].

          (f) Comments. Within 10 days of Patheon’s receipt from the Client of any documents
under paragraphs (c) and (d) above, Patheon shall provide any comments it may have on such
documents in writing to the Client, including any alleged inaccuracies or deficiencies, and
representatives of the parties shall cooperate in good faith with one another over the following
four-day period to address the comments and revise the materials accordingly.

          (g) Deficiencies. In the event the representatives of the parties fail to agree upon
the resolution of any alleged inaccuracies or deficiencies within such four-day period, the program
directors or equivalent executives of each of Patheon and the Client shall meet as promptly as
possible to discuss and attempt to resolve the dispute. If the program directors or equivalent
executive are unable to resolve the dispute (or otherwise fail to meet) within the following 10-day
period, then the parties will submit the dispute to an independent scientific mediator mutually
selected by the parties. None of such mediator candidates may have been previously employed or
otherwise received compensation from either the Client or Patheon except pursuant to any earlier
dispute between Client and Patheon. The selected mediator shall hold any proceedings deemed
necessary and make his or her findings within 30 days of his or her selection. The findings of the
mediator shall be conclusive and binding upon the parties for purposes of any subsequent
submissions to the Regulatory Authority and the parties shall thereafter cooperate with one another
in connection with any pre-approval inspection by the FDA that may follow. All out-of-pocket costs
relating to the dispute resolution process, including the mediator’s fees and expenses, shall be
borne solely by the unsuccessful party or as otherwise determined by the mediator.

          (h) Client Responsibility. For clarity, the parties agree that in reviewing the
documents referred to in paragraphs (c) and (d) above, Patheon’s role will be limited to verifying

 

			
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the accuracy of the description and documentation of the work undertaken or to be undertaken by
Patheon. As such, Patheon shall not assume any responsibility for the accuracy of the NDA or
the ANDA, as the case may be. The sole responsibility of the preparation and filing of the
NDA shall be borne by the Client.

ARTICLE 8.

TERM AND TERMINATION

8.1 Initial Term.

          This Agreement shall become effective as of the date of execution hereof by both parties and
shall continue until the date that is five Years from the Commencement Date (the “Initial Term”),
unless terminated earlier by one of the parties in accordance herewith. This Agreement shall
automatically continue after the Initial Term for successive terms of 12 months each unless either
party gives written notice to the other party of its intention to terminate this Agreement at least
18 months prior to the end of the then current term.

8.2 Termination for Cause.

          (a) Either party at its sole option may terminate this Agreement upon written notice in
circumstances where the other party has failed to remedy a material breach of any of its
representations, warranties or other obligations under this Agreement within 60 days following
receipt of a written notice of said breach that expressly states that it is a notice under this
Section 8.2(a).

          (b) Either party at its sole option may immediately terminate this Agreement upon written
notice, but without prior advance notice, to the other party in the event that: (i) the other party
is declared insolvent or bankrupt by a court of competent jurisdiction; (ii) a voluntary petition
of bankruptcy is filed in any court of competent jurisdiction by such other party; or (iii) this
Agreement is assigned by such other party for the benefit of creditors.

          (c) The Client may terminate this Agreement as to any Product upon 30 days’ prior written
notice in the event that any Authority takes any action, or raises any objection, that prevents the
Client from importing, exporting, purchasing or selling such Product.

8.3 Product Partnering.

          The Client may, at its sole option, terminate this Agreement upon 12 months’ prior written
notice to Patheon in connection with the Client’s partnering, collaboration, licensing,
sublicensing, co-promotion, sale or divestiture of rights to any Product; provided, however, that
no such termination shall be effective prior to the 36th month anniversary of the
Commencement Date of this Agreement.

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8.4 Product Discontinuation.

          The Client shall provide at least [***] months’ advance notice if it intends to no longer
order a Product due to that Product’s discontinuance in the market.

8.5 Obligations on Termination.

          If this Agreement expires or is terminated in whole or in part for any reason, then (in
addition to any other remedies either party may have in the event of default by the other party):

          (a) Patheon shall cease the manufacture of Products and shall terminate any unfilled orders
with third parties that Patheon may have previously submitted with respect to Active Materials and
Components to the extent such orders may be terminated or revoked;

          (b) the Client shall take delivery of and pay for all undelivered Products that are
manufactured and/or packaged pursuant to a Firm Order, at the price in effect at the time the Firm
Order was placed; provided that no such payment shall be due from the Client if this Agreement is
terminated by Client pursuant to Section 8.2(a), including, but not limited to,
termination for Patheon’s failure to provide Manufacturing Services in respect of such
undelivered Products in accordance with the Specifications and cGMPs;

          (c) the Client shall purchase, at Patheon’s [***] costs ([***] in connection with the purchase
and handling of such Inventory), the Inventory applicable to the Products which was purchased,
produced or maintained by Patheon in contemplation of filling Firm Orders or in accordance with
Section 5.2 prior to notice of termination being given; provided that no such payment shall be due
from the Client if this Agreement is terminated by Client pursuant to Section 8.2(a), including,
but not limited to, termination for Patheon’s failure to provide Manufacturing Services in
accordance with the Specifications and cGMPs;

          (d) the Client shall satisfy the purchase price payable pursuant to Patheon’s orders with
suppliers of Components, provided such orders were made by Patheon in reliance on Firm Orders or in
accordance with Section 5.2; provided that no such payment shall be due from the Client if this
Agreement is terminated by Client pursuant to Section 8.2(a), including, but not limited to,
termination for Patheon’s failure to provide Manufacturing Services in accordance with the
Specifications and cGMPs;

          (e) if this Agreement is terminated by Client pursuant to Section 8.2(a), including, but not
limited to, termination for Patheon’s failure to provide Manufacturing Services in accordance with
the Specifications and cGMPs, the Client shall have the option but not the obligation to take title
to, possession of, all of any (i) undelivered Products and (ii) Inventory, including, but not
limited to Active Materials and/or Components, in each case only after the

 

			
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Client has made any payment(s) which may be required under this Section 8.5 above, and Patheon shall cooperate with the
Client in the surrender, delivery and transfer of such items as promptly as is commercially
reasonable, with any shipping and related expenses to be borne by [***];

          (f) if this Agreement is terminated for any reason other than pursuant to Section 8.2(a), the
Client shall have the obligation to take title to, possession of, all of any (i) undelivered
Products and (ii) Inventory, including, but not limited to Active Materials and/or
Components, in each case only after the Client has made any payment(s) which may be required
under this Section 8.5 above, and Patheon shall cooperate with the Client in the surrender,
delivery and transfer of such items as promptly as is commercially reasonable, with any shipping
and related expenses to be borne by [***];

          (g) upon the request of the Client, and at the Client’s expense, Patheon shall provide such
assistance as is reasonably necessary to assist the Client in transferring the manufacture of the
Product to another facility; provided, however, no competitor of Patheon shall be permitted to have
access to the Manufacturing Site; and

          (h) upon the request of the Client, Patheon shall cooperate in the technology transfer of the
manufacture of the Products to a third-party supplier/manufacturer selected by the Client in its
sole discretion. In furtherance of the technology transfer, Patheon shall make its employees and
other internal resources reasonably available to the Client and the designated third-party
supplier/manufacturer and provide copies of all technology, documents, data and other information
constituting manufacturing know-how or otherwise necessary for regulatory qualification of the
successor manufacturing process. Any such third-party supplier/ manufacturer that the Client may
designate to manufacture the Products shall be required to sign a customary and appropriate
confidentiality agreement with Patheon with respect to the nondisclosure and use of any such
manufacturing know-how or other confidential information transferred. With respect to all
documents, data and other information provided in connection with the technology transfer, (i)
Patheon shall be responsible for the cost of providing a single copy only; and (ii) in addition to
paper and other tangible copies, Patheon shall, upon the Client’s request, also provide to the
Client and/or the third-party supplier/manufacturer electronic copies of such documents, data and
other information, provided, that, Patheon or its affiliates have electronic copies thereof, and
provided, further, that Patheon shall have no obligation to reformat or otherwise alter or modify
any such electronic materials. Notwithstanding the foregoing, no competitor of Patheon shall be
permitted to have access to the Manufacturing Site without Patheon’s written consent. In order to
facilitate the technology transfer contemplated hereby, Patheon shall provide to the Client the
services of at least the equivalent of [***] full-time
equivalent (“FTE”) [***]. In addition to the foregoing FTE, the Client shall reimburse
Patheon for its costs associated with the transfer of technology contemplated by this subsection
(h) unless the transfer is in connection with the termination of this Agreement by the Client
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Section 8.2(a), including, but not limited to, termination for Patheon’s failure to
provide Manufacturing Services in accordance with the Specifications and cGMPs.

Any termination or expiration of this Agreement shall not affect any outstanding obligations or
payments due hereunder prior to such termination or expiration, nor shall it prejudice any other
remedies that the parties may have under this Agreement. For greater certainty, termination of
this Agreement for any reason shall not affect the obligations and responsibilities of the parties
pursuant to Sections 6.2, 6.3, 6.4, 6.5, 7.2, 7.3, 7.4, 7.6, 7.7, 8.5, Articles 10, 11 and 12 and
Sections 13.1, 13.2, 13.3, 13.4, 13.5, 13.6, 13.7, 13.11 and 13.16, all of which survive any
termination.

ARTICLE 9.

REPRESENTATIONS, WARRANTIES AND COVENANTS

9.1 Each Party.

          Each party covenants, represents and warrants that:

          (a) it has the full right and authority to enter into this Agreement, and that it is not aware
of any impediment that would inhibit its ability to perform its obligations hereunder;

          (b) this Agreement has been duly executed and delivered by, and is a legal and valid
obligation binding upon such party, subject to the effects of bankruptcy, insolvency, or other laws
of general application affecting the enforcement of creditor rights and judicial principles
affecting the availability of specific performance and general principles of equity, whether
enforceability is considered a proceeding at law or equity; and

          (c) the entry into, the execution and delivery of, and the carrying out and other performance
of its obligations under this Agreement by such party (i) does not conflict with, or contravene or
constitute any default under, any agreement, instrument or understanding, oral or written, to which
it is a party, including, but not limited to, its certificate of incorporation or by-laws, and (b)
does not violate Applicable Laws or any judgment, injunction, order or decree of any Authority
having jurisdiction over it.

9.2 Client Warranties.

          The Client covenants, represents and warrants that:

          (a) the Specifications for each of the Products are its or its Affiliate’s property and that
the Client may lawfully disclose the Specifications to Patheon;

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          (b) any Intellectual Property included in the Specifications or otherwise provided to Patheon
by the Client to be utilized by Patheon and in connection with the provision of the Manufacturing
Services, other than Patheon Intellectual Property, (i) is the Client’s or its Affiliate’s
unencumbered property, (ii) may be lawfully used as directed by the Client, and (iii) such use does
not infringe and will not infringe any Third Party Rights;

          (c) to the knowledge of the Client, the provision of the Manufacturing Services by Patheon in
respect of any Product pursuant to this Agreement or use or other disposition of any Product by
Patheon as may be required to perform its obligations under this Agreement does not and will not
infringe any Third Party Rights;

          (d) the Client is not aware of any pending or threatened claims against the Client, the
subject of which is the infringement of Third Party Rights related to any of the Specifications, or
any of the Active Materials and the Components, or the sale, use or other disposition of any
Product made in accordance with the Specifications;

          (e) following approval by the applicable Authority, the Specifications for all Products will
conform to all Applicable Laws, including, without limitation, cGMPs; and

          (f) the Products, if labeled and manufactured in accordance with the Specifications and in
compliance with Applicable Laws, including, without limitation cGMPs, (i) may be lawfully sold and
distributed in every jurisdiction in which the Client markets such Products, (ii) will be fit for
the purpose intended, and (iii) will be safe for human consumption.

9.3 Patheon Warranties.

          Patheon covenants, represents and warrants that:

          (a) it shall perform the Manufacturing Services in accordance with the Specifications and
cGMPs;

          (b) it has and will maintain throughout the term of this Agreement, the expertise, with
respect to personnel and equipment, to fulfill the obligations established hereunder, and has
obtained all requisite material licenses, authorizations and approvals required by all Authorities
to manufacture the Products;

          (c) the Manufacturing Site, all other facilities, all equipment and all personnel to be
employed by Patheon in rendering the Manufacturing Services are currently, and will be at the time
each batch of Products is produced, qualified in accordance with all Applicable Laws, including,
but not limited to, cGMPs;

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          (d) there are no pending or uncorrected citations or adverse conditions noted in any
inspection of the Manufacturing Site or any other facilities to be employed by Patheon in rendering
the Manufacturing Services which would cause the Products to be misbranded or adulterated within
the meaning of the Act, including, but not limited to, all cGMPs;

          (e) to the knowledge of Patheon, the Manufacturing Services and the contributions of Patheon
to the manufacture of the finished Product in accordance with this Agreement do not and will not
infringe any Third Party Rights provided, however, that Patheon does not warrant against
infringement attributable to the finished Product which, when used together with Patheon’s
manufacturing processes, results in a claim for infringement;

          (f) Patheon is not aware of any pending or threatened claims against Patheon asserting that
any of the activities of Patheon relating to the manufacture, import, use, or sale of
pharmaceutical products, or the conduct of the activities contemplated herein by the Client,
infringe, misappropriate, or violate the rights of any Third Party Rights; and

          (g) all employees, consultants, subcontractors and agents performing services for Patheon
hereunder have assigned, or will assign, in writing to Patheon all of their right, title and
interest in, to and under any and all Inventions directly relating to the Product.

          (h) all Product manufactured and supplied to the Client under this Agreement shall not be
adulterated or misbranded within the meaning of the Act or other Applicable Laws as of the time
that the finished Product is transferred to the carrier at Patheon’s shipping point.

          (i) all Product manufactured and supplied to the Client under this Agreement shall have the
minimum shelf life specified for such Product in the Specifications and, in any event, shall be
shipped to the Client promptly (and in any event not more than three (3) months) after the date of
its manufacture.

9.4 Debarred Persons.

          Patheon covenants that it will not in the performance of its obligations under this Agreement
use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b).
Patheon represents that it does not currently have, and covenants that it will not hire, as an
officer or an employee any person who has been convicted of a felony under the laws of the United
States for conduct relating to the regulation of any drug product under the Act.

9.5 Permits.

     (a) The Client shall be solely responsible for obtaining or maintaining, on a timely basis,
any permits or other regulatory approvals in respect of the Products or the Specifications,
including, without limitation, all marketing and post-marketing approvals.

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          (b) Patheon shall be solely responsible for obtaining and maintaining all permits, site
licenses or other regulatory approvals for the manufacture of Products. In carrying out its
obligations under this Agreement, Patheon shall comply with all applicable environmental and health
and safety Laws (current or as amended or added), and shall be solely responsible for determining
how to comply with same in carrying out these obligations. Notwithstanding the foregoing, nothing
provided to Patheon by the Client, by way of materials, specifications, processing information or
otherwise, is meant to diminish Patheon’s responsibility for such compliance. Patheon shall
promptly notify the Client of any circumstances, including the receipt of any notice, warning,
citation, finding, report or service of process or the occurrence of any release, spill, upset, or
discharge of hazardous substances (as may be defined under Applicable Laws) relating to Patheon’s
compliance with this Section 9.5(b) and which relates to the manufacture of the Products.

9.6 Compliance with Laws.

          Each party, in connection with its performance under this Agreement, shall comply with all
Applicable Laws.

9.7 No Other Warranty.

          NEITHER PARTY MAKES ANY WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW,
OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT. PATHEON MAKES NO WARRANTY OF
FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY OF MERCHANTABILITY WITH RESPECT TO THE PRODUCTS.

ARTICLE 10.

REMEDIES AND INDEMNITIES

10.1 Consequential Damages.

          Under no circumstances whatsoever shall either party be liable to the other in contract, tort,
negligence, breach of statutory duty or otherwise for any (direct or indirect) loss of profits, of
production, of anticipated savings, of business or goodwill or for any liability, damage, costs or
expense of any kind incurred by the other party of an indirect or consequential nature.

10.2 Limitation of Liability.

          (a) Active Materials. Under no circumstances whatsoever shall [***] be responsible
for any loss or damage to the Active Materials unless the Active Materials are lost or

 

			
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damaged
through the negligence or willful misconduct of [***]. [***] for such Active Materials shall be
limited to the [***].

          (b) Products. Except to the extent that Patheon has failed to provide the
Manufacturing Services in accordance with the Specifications, cGMPs, Applicable Laws or Section 9.3
of this Agreement, Patheon shall not be liable nor have any responsibility for any deficiencies in,
or other liabilities associated with, any Product manufactured by it, including, without
limitation, the costs and expenses of any Recall (collectively, “Product Claims”). For greater
certainty, Patheon shall have no obligation for any Product Claims to the extent such Product Claim
(i) is caused by deficiencies with respect to the Specifications, the safety, efficacy or
marketability of the Products or any distribution thereof, (ii) results from a defect in the Active
Materials or Components that is not reasonably discoverable by Patheon using the test methods set
forth in the Specifications, (iii) is caused by actions of third parties occurring after such
Product is shipped by Patheon pursuant to Section 5.4, (iv) is due to packaging or labeling
defects or omissions for which Patheon has no responsibility, or (d) is due to any other
breach by the Client of its obligations under this Agreement.

           (c) Maximum Liability. Except as set forth in Sections 10.2(a) and 10.3, and
excluding Patheon’s liability for replacement Product under Article 6, Patheon’s maximum liability
under this Agreement for any reason whatsoever, shall not exceed in a Year, in the aggregate, the
greater of $[***] or [***]% of the purchase price for Product arising from Firm Orders submitted in
such Year up to a cap of $[***].

10.3 Patheon.

          Subject to Sections 10.1 and 10.2, Patheon agrees to defend, indemnify and hold the Client,
its officers, employees and agents harmless against any and all losses, damages, costs, claims,
demands, judgments and liability to, from and in favor of third parties (other than Affiliates)
resulting from, or relating to any claim of personal injury or property damage to the extent that
such injury or damage is the result of (a) a failure by Patheon to provide the Manufacturing
Services in accordance with the Specifications, cGMPs, or Applicable Laws, or (b) any other breach
of this Agreement by Patheon, including, without limitation, any representation, warranty or
covenant contained herein, except to the extent that any such losses, damages, costs, claims,
demands, judgments and liability are due to the negligence or wrongful act(s) of the Client, its
officers, employees or agents or Affiliates. Patheon’s obligations under this Section 10.3 shall
not be subject to the maximum liability limitation set forth in Section 10.2(c).

          In the event of a claim, the Client shall: (i) promptly notify Patheon of any such claim; (ii)
use commercially reasonable efforts to mitigate the effects of such claim; (iii) reasonably
cooperate with Patheon in the defense of such claim; (iv) permit Patheon to control the defense and
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10.4 Client.

          Subject to Sections 10.1 and 10.2, the Client agrees to defend, indemnify and hold Patheon,
its officers, employees and agents harmless against any and all losses, damages, costs,
claims, demands, judgments and liability to, from and in favor of third parties (other than
Affiliates) resulting from, or relating to (a) any claim of infringement or alleged infringement of
any Third Party Rights in respect of the Products, or (b) any claim of personal injury or property
damage to the extent that such injury or damage is the result of a breach of this Agreement by the
Client, including, without limitation, any representation or warranty contained herein, except to
the extent that any such losses, damages, costs, claims, demands, judgments and liability are due
to the negligence or wrongful act(s) of Patheon, its officers, employees or agents or Affiliates.

          In the event of a claim, Patheon shall: (i) promptly notify the Client of any such claims;
(ii) use commercially reasonable efforts to mitigate the effects of such claim; (iii) reasonably
cooperate with the Client in the defense of such claim; (iv) permit the Client to control the
defense and settlement of such claim, all at the Client’s cost and expense.

10.5 Indemnification Procedure.

          (a) Each indemnified party (the “Indemnitee”) agrees to give the indemnifying party (the
“Indemnitor”) prompt written notice of any Claims or discovery of fact upon which the Indemnitee
intends to base a request for indemnification. Notwithstanding the foregoing, the failure to give
timely notice to the Indemnitor shall not release the Indemnitor from any liability to the
Indemnitee to the extent the Indemnitor is not materially prejudiced thereby.

          (b) The Indemnitee shall furnish promptly to the Indemnitor copies of all papers and official
documents in the Indemnitee’s possession or control which relate to any Claims; provided, however,
that if the Indemnitee defends or participates in the defense of any Claims, then the Indemnitor
shall also provide such papers and documents to the Indemnitee. The Indemnitee shall reasonably
cooperate with the Indemnitor in defending against any Claims.

          (c) The Indemnitor shall have the right, by prompt written notice to the Indemnitee, to assume
direction and control of the defense of any Claim, with counsel reasonably satisfactory to the
Indemnitee and at the sole cost of the Indemnitor, so long as (i) the Indemnitor shall promptly
notify the Indemnitee in writing (but in no event more than thirty (30) days after the Indemnitor’s
receipt of notice of the Claim) that the Indemnitor intends to
indemnify the Indemnitee pursuant to this Article absent the development of facts that give
the Indemnitor the right to claim indemnification from the Indemnitee, and (ii) the Indemnitor
diligently pursues the defense of the Claim.

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          (d) If the Indemnitor assumes the defense of the Claim as provided in this Section 10.5, the
Indemnitee may participate in such defense with the Indemnitee’s own counsel who shall be retained,
at the Indemnitee’s sole cost and expense; provided, however, that neither the Indemnitee nor the
Indemnitor shall consent to the entry of any judgment or enter into any settlement with respect to
the Claim without the prior written consent of the other party, which consent shall not be
unreasonably withheld or delayed. If the Indemnitee withholds consent in respect of a judgment or
settlement involving only the payment of money by the Indemnitor and which would not involve any
stipulation or admission of liability or result in the Indemnitee becoming subject to injunctive
relief or other relief, the Indemnitor shall have the right, upon written notice to the Indemnitee
within five days after receipt of the Indemnitee’s written denial of consent, to pay to the
Indemnitee, or to a trust for its or the applicable third party’s benefit, such amount established
by such judgment or settlement in addition to all interest, costs or other charges relating
thereto, together with all attorneys’ fees and expenses incurred to such date for which the
Indemnitor is obligated under this Agreement, if any, at which time the Indemnitor’s rights and
obligations with respect to such Claim shall cease.

          (e) The Indemnitor shall not be liable for any settlement or other disposition of a Claim by
the Indemnitee which is reached without the written consent of the Indemnitor.

ARTICLE 11.

CONFIDENTIALITY

11.1 Confidentiality.

          The parties agree that, for the term of this Agreement and for seven years thereafter (other
than for trade secrets, for which the confidentiality obligations set forth herein shall last as
long as trade secret law shall allow), all non-public, proprietary or “confidential” disclosures,
know-how, data, and technical, financial and other information of any nature whatsoever
(collectively, “Confidential Information”), disclosed or submitted, either orally or in
writing (including, without limitation, by electronic means) or through observation, by one
party (the “Disclosing Party”) to the other party (the “Receiving Party”) hereunder, including,
without limitation, the terms of this Agreement, shall be received and maintained by the Receiving
Party in strict confidence, shall not be used for any purpose other than the purposes expressly
contemplated by this Agreement, and shall not be disclosed to any third party (including, without
limitation, in connection with any publications, presentations or other disclosures).
Notwithstanding the foregoing, (a) either party may disclose on a need-to-know basis the existence
of this Agreement and the terms hereof to any bona fide potential acquirers, corporate partners,
investors or financial advisors; (b) the Client may disclose that Patheon is a supplier to the
Client with respect to the Product; (c) Patheon may disclose the fact that the Client is a client
of Patheon but shall not disclose any other information relating to any product for which Patheon
provides services to the Client. The Receiving Party will promptly notify the Disclosing Party

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upon discovery of any unauthorized use or disclosure of the Disclosing Party’s Confidential
Information. Confidential Information belongs to and shall remain the property of the Disclosing
Party.

11.2 Exceptions.

          The provisions of Section 11.1 shall not apply to any information of the Disclosing Party
which can be shown by competent evidence by the Receiving Party:

          (a) to have been known to or in the possession of the Receiving Party prior to the date of its
actual receipt from the Disclosing Party as evidenced by the Receiving Party’s written records;

          (b) to be or to have become readily available to the public other than through any act or
omission of any party in breach of any confidentiality obligations owed to the Disclosing Party;

          (c) to have been disclosed to the Receiving Party, other than under an obligation of
confidentiality, by a third party which had no obligation to the Disclosing Party not to disclose
such information to others; or

          (d) to have been subsequently independently developed by the Receiving Party without use of or
reference or access to the Disclosing Party’s Confidential Information as evidenced by the
Receiving Party’s written records.

11.3 Authorized Disclosure.

          The Receiving Party may disclose the Disclosing Party’s Confidential Information hereunder
solely to the extent (a) approved by the Disclosing Party; or (b) the Receiving Party is legally
required to disclose such Confidential Information; provided, however, that prior to any such
required disclosure, the Receiving Party will, except where impracticable, give reasonable advance
written notice to the Disclosing Party of such disclosure (so that the Disclosing Party may seek a
protective order and or other appropriate remedy or waive compliance with the confidentiality
provisions of this Article 11) and will use good faith efforts to secure confidential treatment of
such Confidential Information required to be disclosed. In the event that a party makes a
disclosure of Confidential Information deemed necessary under applicable federal or state
securities laws or any rule or regulation of a nationally recognized securities exchange, the party
shall use good faith efforts to obtain confidential treatment for the disclosure to the extent
available. The party making such a disclosure shall provide the other party with reasonable
advance written notice of its intent to make such a disclosure and shall provide the other party
the opportunity to comment on any confidential treatment requested prior to the submission.

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11.4 Return of Confidential Information.

          The Receiving Party shall keep the Disclosing Party’s Confidential Information in
appropriately secure locations. Upon the expiration or termination of this Agreement or at any
time upon the Disclosing Party’s request, the Receiving Party shall destroy or return to the
Disclosing Party, at the Disclosing Party’s written request, all Confidential Information belonging
to the Disclosing Party possessed by the Receiving Party, or its officers, directors, employees,
agents and consultants; provided, however, that a Receiving Party may retain one (1) copy of the
Disclosing Party’s Confidential Information in an appropriately secure location, which by
Applicable Laws it must retain, for so long as such Applicable Laws require such
retention but thereafter shall dispose of such retained Confidential Information in accordance
with Applicable Laws or this Section 11.4.

11.5 Equitable Relief.

          The Receiving Party agrees that, due to the unique nature of the Confidential Information, the
unauthorized disclosure or use of the Confidential Information of the Disclosing Party may cause
irreparable harm and significant injury to the Disclosing Party, the extent of which may be
difficult to ascertain and for which there may be no adequate remedy at law. Accordingly, the
Receiving Party agrees that the Disclosing Party, in addition to any other available remedies,
shall have the right to seek an immediate injunction and other equitable relief enjoining any
breach or threatened breach of this Agreement. The Receiving Party shall notify the Disclosing
Party in writing immediately upon the Receiving Party’s becoming aware of any such breach or
threatened breach.

ARTICLE 12.

DISPUTE RESOLUTION

12.1 Commercial Disputes.

          In the event of any dispute arising out of or in connection with this Agreement (other than a
dispute determined in accordance with Section 6.1(b) or a Technical Dispute), the parties shall
first try to solve it amicably. In this regard, any party may send a notice of dispute to the
other, and each party shall appoint, within 10 Business Days from receipt of such notice of
dispute, a single representative having full power and authority to solve the dispute. The
representatives so designated shall meet as necessary in order to solve such dispute. If these
representatives fail to solve the matter within one month from their appointment, or if a party
fails to appoint a representative within the 10 Business Day period set forth above, such dispute
shall immediately be referred to the Chief Operating Officer or Executive Vice President,
Operations (or such other officer of comparable or greater authority as they may designate) of each
party who will meet and discuss as necessary in order to try to solve the dispute amicably.

- 33 -

 

Should
the parties fail to reach a resolution under this Section 12.1, their dispute will be referred to a
court of competent jurisdiction in accordance with Section 13.16.

12.2 Technical Dispute Resolution.

          In the event of a dispute (other than disputes in relation to the matters set out in Sections
6.1(b) and 12.1) between the parties that is exclusively related to technical aspects of the
manufacturing, packaging, labeling, quality control testing, handling, storage or other activities
under this Agreement (a “Technical Dispute”), the parties shall make all reasonable efforts to
resolve the dispute by amicable negotiations. In this regard, senior representatives of each party
shall, as soon as practicable and in any event no later than 10 Business Days after a written
request from either party to the other, meet in good faith to resolve any Technical Dispute. If,
despite such meeting, the parties are unable to resolve a Technical Dispute within a reasonable
time, and in any event within 30 Business Days of such written request, the Technical Dispute
shall, at the request of either party, be referred for determination to an expert in accordance
with the provisions of Schedule G. In the event that the parties cannot agree whether a dispute is
a Technical Dispute, Section 12.1 shall prevail. For greater certainty, the parties agree that the
release of the Products for sale or distribution pursuant to the applicable marketing approval for
such Products shall not by itself indicate compliance by Patheon with its obligations in respect of
the Manufacturing Services and further that nothing in this Agreement (including Schedule G) shall
remove or limit the authority of the relevant qualified person (as specified by the Quality
Agreement) to determine whether the Products are to be released for sale or distribution.

ARTICLE 13.

MISCELLANEOUS

13.1 Inventions.

          (a) For the term of this Agreement, Client hereby grants to Patheon a non-exclusive,
royalty-free, non-transferable, non-sublicensable license of Client’s Intellectual Property that
relates to the Product solely to perform the Manufacturing Services.

          (b) All Inventions and other Intellectual Property generated or derived by Patheon in the
course of performing the Manufacturing Services, to the extent it is specific to the development,
manufacture, use and sale of the Client’s Products that is the subject of the
Manufacturing Services (including, but not limited to, any new use, new formulation or any
change in the method of producing, testing or storing any Product), shall be the exclusive property
of Client. Patheon shall execute such instruments as shall be required to evidence or effectuate
the Client’s ownership of any such Inventions or other Intellectual Property, and shall cooperate
upon reasonable request in the prosecution of patents and other Intellectual Property rights
related thereto.

- 34 -

 

          (c) All Intellectual Property generated or derived by Patheon in the course of performing the
Manufacturing Services which are not specific, or dependent upon, Client’s Product and which have
general application to manufacturing processes or formulation development of drug products or drug
delivery systems shall be the exclusive property of Patheon (the “Broader Intellectual Property
Rights”). Patheon hereby grants to Client, a worldwide, perpetual, irrevocable, non-exclusive,
paid-up, royalty-free, transferable and sublicensable license of Patheon’s Broader Intellectual
Property Rights to manufacture and have manufactured the Products and to use, import, export, offer
to sell, and sell the same, with full right to sublicense to any third party in connection with the
manufacture, sale or distribution of the Product.

          (d) Each party shall be solely responsible for the costs of filing, prosecution and
maintenance of patents and patent applications on its own Inventions.

          (e) Either party shall give the other party written notice, as promptly as practicable, of all
Inventions which can reasonably be deemed to constitute improvements or other modifications of the
Products or the processes for developing or manufacturing the Products owned or otherwise
controlled by such party in respect of the Products.

13.2 Intellectual Property.

          Subject to Section 13.1, all Intellectual Property of the Client shall be owned by the Client
and all Intellectual Property of Patheon shall be owned by Patheon. The Client and Patheon hereby
acknowledge that neither party has, nor shall it acquire, any interest in any of the other party’s
Intellectual Property unless otherwise expressly agreed to in writing. Each party
agrees not to use any Intellectual Property of the other party, except as specifically
authorized by the other party or as required for the performance of its obligations under this
Agreement.

13.3 Insurance.

          Each party shall maintain commercial general liability insurance, including blanket
contractual liability insurance covering the obligations of that party under this Agreement through
the term of this Agreement and for a period of three years thereafter, which insurance, at the time
of FDA approval for the Product, shall afford limits of not less than (i) $[***] for each
occurrence for personal injury or property damage liability; and (ii) $[***] in the aggregate per
annum with respect to product and completed operations liability. If requested each party will
provide the other with a certificate of insurance evidencing the above and showing the name of the
issuing company, the policy number, the effective date, the expiration date and the limits of
liability. The insurance certificate shall further provide for a minimum of 30 days’ written
notice to the insured of a cancellation of, or material change in, the insurance. If a party is
unable to maintain the insurance policies required under this Agreement through no fault on the
part of such party, then such party shall forthwith notify the other party in writing

 

			
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- 35 -

 

and the
parties shall in good faith negotiate appropriate amendments to the insurance provision of this
Agreement in order to provide adequate assurances.

13.4 Independent Contractors.

          The parties are independent contractors and this Agreement shall not be construed to create
between Patheon and the Client any other relationship such as, by way of example only, that of
employer-employee, principal agent, joint-venturer, co-partners or any similar relationship, the
existence of which is expressly denied by the parties hereto, and nothing in this Agreement shall
be construed to give either party the power or authority to act for, bind, or commit the other
party.

13.5 Trademarks.

          The Client and Patheon hereby acknowledge that neither party has, nor shall it acquire, any
interest in any of the other party’s trademarks or trade names unless otherwise
expressly agreed to in writing. Each party agrees not to use any trademark or trade name of
the other party, except as specifically authorized by the other party or as required for the
performance of its obligations under this Agreement.

13.6 No Waiver.

          Either party’s failure to require the other party to comply with any provision of this
Agreement shall not be deemed a waiver of such provision or any other provision of this Agreement.
No waiver shall be effective unless made in writing and signed by the waiving party.

13.7 Assignment.

          (a) Patheon may not assign this Agreement or any of its rights or obligations hereunder except
with the written consent of the Client, such consent not to be unreasonably withheld; provided,
however, that Patheon may arrange for subcontractors to perform specific testing services arising
under this Agreement without the consent of the Client; provided, further, that Patheon shall
provide advance notice of the name and function of any such subcontractor and shall ensure such
subcontractor’s adherence to the terms of this Agreement, including, but not limited to, the
obligations of confidentiality set forth in Article 11.

          (b) The Client may assign this Agreement or any of its rights or obligations hereunder[***]
without approval from Patheon; provided, however, that the Client shall give prior written notice
of any assignment to Patheon, any assignee shall covenant in writing with Patheon to be bound by
the terms of this Agreement and the Client shall remain liable hereunder. [***].

 

			
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- 36 -

 

          (c) Notwithstanding the foregoing provisions of this Section 13.7, either party may assign
this Agreement to any of its Affiliates or to a successor to, purchaser or licensee of all or
substantially all of its business, provided that such assignee agrees in writing to be bound
hereunder. For purposes of the foregoing, the phrase “all or substantially all of its business”
shall mean, with respect to the Client, the business of the Client relating to the Product and not
necessarily any other products to which the Client may have rights.

13.8 Force Majeure.

          Neither party shall be liable for the failure to perform its obligations under this Agreement
if such failure is occasioned by a cause or contingency beyond such party’s reasonable control,
including, but not limited to, the following if such cause or contingency beyond such party’s
reasonable control: strikes or other labor disturbances, lockouts, riots, quarantines,
communicable disease outbreaks, wars, acts of terrorism, fires, floods, storms, interruption of or
delay in transportation, defective equipment, lack of or inability to obtain fuel, power or
components, or compliance with any order or regulation of any Authority acting within color of
right (a “Force Majeure Event”). A party claiming a right to excused performance under this
Section 13.8 shall immediately notify the other party in writing of the extent of its inability to
perform, which notice shall specify the occurrence beyond its reasonable control that prevents such
performance. Notwithstanding the foregoing, if a Force Majeure Event prevents a party’s
performance under this Agreement for an aggregate of 120 days, the other party may terminate this
Agreement upon written notice to the non-performing party.

13.9 Additional Product.

          Additional products may be added to this Agreement and such additional products shall be
governed by the general conditions hereof with any special terms (including, without limitation,
price) governed by an addendum signed by each of the parties hereto.

13.10 Notices.

          Any notice, approval, instruction or other written communication required or permitted
hereunder shall be sufficient if made or given to the other party by personal delivery, by
telecopier or facsimile communication or by sending the same by first class mail, postage prepaid
to the mailing address, or telecopier or facsimile number set forth below:

If to the Client:

Somaxon Pharmaceuticals, Inc.

12750 High Bluff Drive, Suite 310

- 37 -

 

San Diego, CA 92130

Attention: President and Chief Executive Officer

Telecopier No.: 858-509-1589

with a copy to:

Latham & Watkins LLP

12636 High Bluff Drive, Suite 400

San Diego, CA 92130

Attention: Scott N. Wolfe / Cheston J. Larson

Telecopier No.: 858-523-5450

If to Patheon:

Patheon Inc.

7070 Mississauga Road, Suite 350

Mississauga, Ontario L5N 7J8

Canada

Attention: President, Patheon USA

Telecopier No.: 905.812.6705

with a copy to:

Patheon Pharmaceuticals Inc.

2110 East Galbraith Road

Cincinnati, Ohio 45237

Attention: Director of Legal Services

Telecopier No.: 513-948-6927

or to such other addresses or telecopier or facsimile numbers provided to the other party in
accordance with the terms of this Section 13.10. Notices or written communications made or given
by personal delivery or by telecopier or facsimile shall be deemed to have been sufficiently
made or given when sent (receipt acknowledged), or if mailed, five days after being deposited in
the United States or Canadian mail, postage prepaid or upon receipt, whichever is sooner.

13.11 Severability.

          If any provision of this Agreement is determined by a court of competent jurisdiction to be
invalid, illegal or unenforceable in any respect, such determination shall not impair or affect the
validity, legality or enforceability of the remaining provisions hereof, and each provision is
hereby declared to be separate, severable and distinct.

- 38 -

 

13.12 Entire Agreement.

          This Agreement, together with the Quality Agreement constitutes the full, complete, final and
integrated agreement between the parties hereto relating to the subject matter hereof and
supersedes all previous written or oral negotiations, commitments, agreements, transactions or
understandings with respect to the subject matter hereof. Any modification, amendment or
supplement to this Agreement must be in writing and signed by authorized representatives of both
parties. In case of conflict, the prevailing order of documents shall be this Agreement and the
Quality Agreement.

13.13 Other Terms.

          The parties agree that no terms, provisions or conditions of any purchase order or other
business form or written authorization used by the Client or Patheon will have any effect on the
rights, duties or obligations of the parties under or otherwise modify this Agreement, regardless
of any failure of the Client or Patheon to object to such terms, provisions, or conditions unless
such document specifically refers to this Agreement and is signed by both parties.

13.14 No Third Party Benefit or Right.

          For greater certainty, nothing in this Agreement shall confer or be construed as conferring on
any third party any benefit or the right to enforce any express or implied term of this Agreement.

13.15 Execution in Counterparts.

          This Agreement may be executed in two counterparts, by original or facsimile signature, each
of which shall be deemed an original, but all of which together shall constitute one and the same
instrument.

13.16 Governing Law.

          This Agreement shall be construed and enforced under the laws of the State of New York,
without regard to the United Nations Convention on Contracts for the International Sale of Goods
and without giving effect to any choice of laws rule that would cause the application of the laws
of any jurisdiction other than the internal laws of the State of New York, to the rights and duties
of the parties.

[Remainder of Page Left Blank Intentionally]

- 39 -

 

          IN WITNESS WHEREOF, the duly authorized representatives of the parties have executed this
Agreement as of the date first written above.

	 	 	 	 	 
	 	 	PATHEON PHARMACEUTICALS INC.
	 
	 	 	 	 
	 

	 	by	 	/s/ Bradley J. Mitchell
	 

	 	 	 	 
	 
	 	 	 	 
	 

	 	•	 	Treasurer
	 
	 	 	 	 
	 

	 	by	 	Bradley J. Mitchell
	 

	 	 	 	 
	 
	 	 	 	 
	 	 	SOMAXON PHARMACEUTICALS, INC.
	 
	 	 	 	 
	 

	 	by	 	/s/ Kenneth M. Cohen
	 

	 	 	 	 
	 
	 	 	 	 
	 

	 	•	 	President & CEO
	 
	 	 	 	 
	 

	 	by	 	Kenneth M. Cohen
	 

	 	 	 	 
	 
	 	 	 	 
	 

	 	•	 	 

- 40 -

 

SCHEDULE A

PRODUCTS

Doxepin 1, 3, and 6 mg tablets supplied in [***] as shown in Schedule C.

 

			
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SCHEDULE B

PROCEDURE FOR SHIPMENT AND 

ACCEPTANCE OF PRODUCT SPECIFICATIONS

Prior to the commencement of commercial manufacturing of Product under this Agreement the Client
shall provide Patheon with originally executed copies of the FDA approved Specifications. If the
Specifications provided are subsequently amended, then the Client shall provide Patheon with
revised and originally executed copies of such revised Specifications. Upon acceptance of the
revised Specifications, Patheon shall provide the Client with a signed and dated receipt evidencing
such acceptance of the revised Specifications by Patheon.

 

 

SCHEDULE C

MINIMUM RUN QUANTITY, ANNUAL VOLUME AND FEES

	 	 	 	 	 	 	 	 	 	 	 	 	 
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- 8 -

 

SCHEDULE D

STABILITY TESTING

Patheon shall conduct stability studies on the finished Products according to the Specifications
therefor, as required by the FDA or foreign Agencies as advised by the Client or as requested by
the Client, and in any case on:

	•	 	at least the first [***] of finished Product from the Manufacturing Site after the Commencement Date;
	 
	•	 	at least [***] of finished Product [***] per calendar Year thereafter; or
	 
	•	 	The cost of such stability studies shall be as follows or as may otherwise be agreed to between the parties in writing:

	 	 	$[***] per stability time point (multiple samples may tested if they are due at the same time)

Patheon shall provide to the Client a report of all results and data obtained from such stability
studies periodically as may be specified in the stability protocol for the Product and/or the
Quality Agreement.

Patheon and the Client shall agree in writing on any further stability testing to be performed by
Patheon in connection with the Products. Such agreement shall specify the commercial and Product
stability protocols applicable to the stability testing and the fees payable by the Client in
connection with such additional testing.

 

			
	***	 	Certain information on this page has been omitted and filed
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SCHEDULE E

ACTIVE MATERIALS & ACTIVE MATERIALS REIMBURSEMENT VALUE

	 	 	 	 	 
	 	 	 	 	Active Materials
	Active Material	 	Supplier	 	Reimbursement Value
	Doxepin HCI
	 	[***]l	 	$[***] per kg. up to a
	 
	 	 	 	maximum amount of
	 
	 	 	 	$[***] per annum

 

			
	***	 	Certain information on this page has been omitted and filed
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SCHEDULE F

BATCH NUMBERING AND EXPIRATION DATES

Each batch of Product manufactured by Patheon will bear a unique packaging lot number using the
Patheon batch numbering system. This number will appear on the Product label and on the batch
documentation.

Patheon will calculate the expiration date for each batch of Product by adding the expiration
period, supplied by the Client to the date of manufacture of each batch. The expiration date will
appear on the Product label.

 

 

SCHEDULE G

TECHNICAL DISPUTE RESOLUTION

          Technical Disputes which cannot be resolved by negotiation as provided in Section 12.2 shall
be resolved in the following matter:

1. Appointment of Expert. Within 10 Business Days after a party requests pursuant to
Section 12.2 that an expert be appointed to resolve a Technical Dispute, the parties shall jointly
appoint a mutually acceptable expert with experience and expertise in the subject matter of the
dispute. If the parties are unable to so agree within such 10 Business Day period, or in the event
of disclosure of a conflict by an expert pursuant to paragraph 2 hereof which results in the
parties not confirming the appointment of such expert, then an expert (willing to act in that
capacity hereunder) shall be appointed by an experienced arbitrator on the roster of the [American
Arbitration Association].

2. Conflicts of Interest. Any person appointed as an expert shall be entitled to act and
continue to act as such notwithstanding that at the time of his appointment or at any time before
he gives his determination, he has or may have some interest or duty which conflicts or may
conflict with his appointment provided that before accepting such appointment (or as soon as
practicable after he becomes aware of the conflict or potential conflict) he fully discloses any
such interest or duty and the parties shall after such disclosure have confirmed his appointment.

3. Procedure. Where an expert is appointed:

          (a) Timing. The expert shall be so appointed on condition that (i) he promptly fixes
a reasonable time and place for receiving representations, submissions or information from the
parties and that he issues such authorizations to the parties and any relevant third party for the
proper conduct of his determination and any hearing and (ii) he renders his decision (with full
reasons) within 15 Business Days (or such other date as the parties and the expert may agree) after
receipt of all information requested by him pursuant to paragraph 3(b) hereof.

          (b) Disclosure of Evidence. The parties undertake one to the other to provide to any
expert all such evidence and information within their respective possession or control as the
expert may reasonably consider necessary for determining the matter before him which they shall
disclose promptly and in any event within five Business Days of a written request from the relevant
expert to do so.

          (c) Advisors. Each party may appoint such counsel, consultants and advisors as it
feels appropriate to assist the expert in his determination and so as to present their respective
cases so that at all times the parties shall co-operate and seek to narrow and limit the issues to
be determined.

          (d) Appointment of New Expert. If within the time specified in paragraph 3(a) above
the expert shall not have rendered a decision in accordance with his appointment, a new expert may
(at the request of either party) be appointed and the appointment of the existing expert shall
thereupon cease for the purposes of determining the matter at issue between the

 

 

parties save that
if the existing expert renders his decision with full reasons prior to the appointment of the new
expert, then such a decision shall have effect and the proposed appointment of the new expert shall
be withdrawn.

          (e) Final and Binding. The determination of the expert shall, save in the event of
fraud or manifest error, be final and binding upon the parties.

          (f) Costs. Each party shall bear its own costs in connection with any matter referred
to an expert hereunder and, in the absence of express provision in the Agreement to the contrary,
the costs and expenses of the expert shall be borne by the losing party.

For greater certainty, the parties agree that the release of the Products for sale or distribution
pursuant to the applicable marketing approval for such Products shall not by itself indicate
compliance by Patheon with its obligations in respect of the Manufacturing Services and further
that nothing in this Agreement (including this Schedule G) shall remove or limit the authority of
the relevant qualified person (as specified by the Quality Agreement) to determine whether the
Products are to be released for sale or distribution.

- 2 -

 

Quality Agreement: February 1, 2006

SCHEDULE H

QUALITY AGREEMENT

THIS AGREEMENT made as of the 1st day of February 2006

BETWEEN:

SOMAXON
PHARMACEUTICALS, INC.

a corporation existing under the laws of the State of
Delaware,

(the “Client”)

- and-

PATHEON
PHARMACEUTICALS INC.,

a corporation existing under the laws of the State of
Delaware,

Specific
sites covered by this Agreement:

Patheon Pharmaceuticals Inc., 2110 East
Galbraith Drive, Cincinnati, OH 45237-1625

(“Patheon”)

BACKGROUND: Patheon and the Client entered into a manufacturing services agreement dated February
1, 2006 (the “MSA”) under which Patheon agreed to provide pharmaceutical manufacturing services
involving the Products described in Schedule A hereto. Under the MSA Client must provide certain
information to Patheon for Patheon to perform the services (the “Specifications”) and Patheon must
operate within the Specifications. The parties want to allocate responsibility for procedures and
specifications that impact the identity, strength, quality, and purity of the Products.

AGREEMENT: In consideration of the rights conferred and the obligations assumed under the MSA and
herein, and for other good and valuable consideration (the receipt and sufficiency of which are
acknowledged by each party), the parties agree to be legally bound as follows:

 

 

Quality Agreement: February 1, 2006

ARTICLE 1

RESPONSIBILITIES

	1.1	 	Patheon is responsible for all the operations that are marked with “X” in the column
titled “Patheon” and the Client is responsible for all the operations that are marked with “X”
in the column titled “Client”. If marked with “(X)”, the designated party will cooperate.

	 	(a)	 	General

	 	 	 	 	 	 	 
	 	 	 	 	Client	 	Patheon
	1.

	 	Provide Specifications.
	 	X
	 	(X)
	 
	 	 	 	 	 	 
	2.

	 	Manufacture and package
Product(s) according to the
Specifications.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.

	 	Permit GMP audits of all
relevant premises, procedures and
documentation by Client, and
permit inspection by regulatory
authorities.
	 	 	 	X
	 
	 	 	 	 	 	 
	4.

	 	Will not subcontract any of
the work to a third party without
prior written consent of
Client.
	 	 	 	X
	 
	 	 	 	 	 	 
	5.

	 	Provide copies of Annual
Product Review reports when
requested by Client.
	 	 	 	X
	 
	 	 	 	 	 	 
	6.

	 	Provide copies of
information and correspondence
necessary to support the Annual
Report when requested by
Client.
	 	 	 	X
	 
	 	 	 	 	 	 
	7.

	 	Notify and obtain written
approval from the Client before
initiating any proposed changes to
the process, materials, testing,
equipment or premises that may
affect the Product(s). Client
approval will not be unreasonably
withheld.
	 	(X)
	 	X
	 
	 	 	 	 	 	 
	8.

	 	Notify the Client within
one business day of receipt of any
FDA Form 483’s, warning letters or
the like from regulatory agencies
relating to: (i) the Product(s);
(ii) the supply of Product(s) or
(iii) the facilities used to
produce, test or package the
Product(s). Client will review and
approve in writing responses that
relate directly to the Product(s)
before submitting to the
regulatory agency. Patheon
	 	(X)
	 	X

- 2-

 

Quality Agreement: February 1, 2006

	 	 	 	 	 	 	 
	 	 	 	 	Client	 	Patheon
	 

	 	reserves the right to respond to such
regulatory agencies without approval, if, in
the reasonable opinion of Patheon’s counsel,
it is required to do so.	 	 	 	 
	 
	 	 	 	 	 	 
	9.

	 	Notify the Client within one business
day of any regulatory authority requests for
samples, batch documentation, or other
information related to the Product(s).
	 	 	 	X
	 
	 	 	 	 	 	 
	10.

	 	Conduct operations in compliance with
applicable federal, state and local
environmental, occupational health and safety
laws, and cGMP regulations.
	 	 	 	X
	 
	 	 	 	 	 	 
	11.

	 	Investigate all medical and non-medical
product complaints related to the
manufacturing of the Product(s).
	 	X
	 	(X)
	 
	 	 	 	 	 	 
	12.

	 	Investigate all manufacturing Product
complaints provided by Client.
	 	(X)
	 	X
	 
	 	 	 	 	 	 
	13.

	 	Notify other party within one business
day of receipt of information meeting NDA
Field Alert criteria as defined in 21
CFR 314.81(b)(l).
	 	X
	 	X
	 
	 	 	 	 	 	 
	14.

	 	Initiate NDA Field Alert reports.
	 	X	 	 
	 
	 	 	 	 	 	 
	15.

	 	Initiate and manage Product recalls.
	 	X
	 	(X)
	 
	 	 	 	 	 	 
	16.

	 	Timely liaise with Regulatory
Authorities for approval, maintenance and
updating of marketing approval.
	 	X	 	 

	 	(b)	 	Validation and Process Testing Activities

	 	 	 	 	 	 	 
	 	 	 	 	Client	 	Patheon
	1.

	 	Establish applicable
master validation plans and
maintain a validation program
for the Product(s).
	 	X
	 	X
	 
	 	 	 	 	 	 
	2.

	 	Qualify (IQ/OQ)
facilities, utilities,
laboratory equipment and
process equipment.
	 	 	 	X

- 3-

 

Quality Agreement: February 1, 2006

	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Client	 	Patheon
	3.

	 	Calibrate instrumentation and qualify computer systems used
in the manufacture and testing of the Product(s).
	 	 	 	 	 	X
	 
	 	 	 	 	 	 	 	 
	4.

	 	Prepare all validation protocols and reports, for
manufacturing, and packaging operations.
	 	 	 	(X)
	 	X
	 
	 	 	 	 	 	 	 	 
	5.

	 	Review and approve master validation plan, and validation
protocols and reports for manufacturing and packaging of the
Product(s).
	 	 	 	X
	 	X
	 
	 	 	 	 	 	 	 	 
	6.

	 	Maintain appropriate equipment cleaning procedures and
cleaning validation program.
	 	 	 	 	 	X
	 
	 	 	 	 	 	 	 	 
	7.

	 	Provide toxicological information to be used in the
development of a cleaning program.
	 	 	 	X	 	 
	 
	 	 	 	 	 	 	 	 
	8.

	 	Validate analytical test methods for finished Product(s).
	 	 	 	 	 	X

	 	(c)	 	Raw Materials

	 	 	 	 	 	 	 
	 	 	 	 	Client	 	Patheon
	1.

	 	Provide the master formula including Bill of Materials.
	 	X
	 	(X)
	 
	 	 	 	 	 	 
	2.

	 	Provide approved supplier list. Client to audit and approve
API suppliers and ensure cGMP compliance where Client stipulates
the supplier. Client stipulated suppliers will be included on
Client’s approved supplier list (attached hereto as Schedule
D).
	 	X	 	 
	 
	 	 	 	 	 	 
	3.

	 	Client to qualify and approve product specific excipient
suppliers and ensure cGMP compliance. Client stipulated suppliers
will be included on Client’s approved supplier list (attached
hereto as Schedule D).
	 	X	 	 
	 
	 	 	 	 	 	 
	4.

	 	Patheon to qualify and approve excipient suppliers and
ensure cGMP compliance where Patheon stipulates the suppliers.
Patheon stipulated suppliers will be included on the Patheon
approved supplier list (Schedule C).
	 	 	 	X
	 
	 	 	 	 	 	 
	5.

	 	Provide API specifications.
	 	X	 	 

- 4-

 

Quality Agreement: February 1, 2006

	 	 	 	 	 	 	 
	 	 	 	 	Client	 	Patheon
	6.

	 	Procure API (including Certificates of Analysis).
	 	 	 	X
	 
	 	 	 	 	 	 
	7.

	 	Validate non-Compendial testing methods for API.
	 	(X)
	 	X
	 
	 	 	 	 	 	 
	8.

	 	Analyze and release API.
	 	 	 	X
	 
	 	 	 	 	 	 
	9.

	 	Retain reference sample of API for one year past the
expiration date of the last batch of Product(s) manufactured
with that material in the Product(s) or such longer period
required by law.
	 	 	 	X
	 
	 	 	 	 	 	 
	10.

	 	Procure inactive ingredients (including
Certificates of Analysis).
	 	 	 	X
	 
	 	 	 	 	 	 
	11.

	 	Provide test methods and method validation for
inactive ingredients (if non-Compendial).
	 	X
	 	(X)
	 
	 	 	 	 	 	 
	12.

	 	Analyze and release inactive ingredients.
	 	 	 	X
	 
	 	 	 	 	 	 
	13.

	 	Retain reference samples of inactive ingredients for
3 years or such longer period as required by law.
	 	 	 	X
	 
	 	 	 	 	 	 
	14.

	 	Maintain records and evidence on the testing of raw
materials for five years after the materials were last used
in the manufacture of the Product(s).
	 	 	 	X
	 
	 	 	 	 	 	 
	15.

	 	At Client’s request, confirm that all bovine,
caprine, or ovine derived raw materials purchased by Patheon
for the manufacture of Product(s) have a BSE/TSE certificate
of compliance from the raw material vendor.
	 	 	 	X

	 	(d)	 	Bulk Manufacture

	 	 	 	 	 	 	 
	 	 	 	 	Client	 	Patheon
	1.

	 	Create, control, issue and execute master batch record.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.

	 	Approve master batch record.
	 	X
	 	X
	 
	 	 	 	 	 	 
	3.

	 	Document, investigate and resolve deviations from approved
manufacturing instructions or specifications.
	 	(X)
	 	X

- 5-

 

Quality Agreement: February 1, 2006

	 	(e)	 	Packaging

	 	 	 	 	 	 	 
	 	 	 	 	Client	 	Patheon
	1.

	 	Provide specifications for packaging components.
	 	X
	 	(X)
	 
	 	 	 	 	 	 
	2.

	 	Review and approve labelling proofs.
	 	X	 	 
	 
	 	 	 	 	 	 
	3.

	 	Provide artwork and labelling text (blister,
carton, leaflet, label etc.) specifications.
	 	X
	 	(X)
	 
	 	 	 	 	 	 
	4.

	 	Create, control, issue and execute master packaging
record.
	 	 	 	X
	 
	 	 	 	 	 	 
	5.

	 	Approve master packaging record.
	 	X
	 	X
	 
	 	 	 	 	 	 
	6.

	 	Qualify and approve packaging component suppliers.
Client to qualify and approve packaging component suppliers
and ensure cGMP compliance where Client stipulates the
supplier. Client stipulated suppliers will be included on
its approved supplier list (attached hereto as Schedule
D).
	 	X
	 	(X)
	 
	 	 	 	 	 	 
	7.

	 	Patheon to qualify and approve packaging component
suppliers and ensure cGMP compliance where Patheon
stipulates the supplier. Patheon stipulated suppliers will
be included on its approved supplier list (Schedule
C).
	 	 	 	X
	 
	 	 	 	 	 	 
	8.

	 	Provide test methods for packaging components.
	 	(X)
	 	X
	 
	 	 	 	 	 	 
	9.

	 	Procure packaging components.
	 	 	 	X
	 
	 	 	 	 	 	 
	10.

	 	Analyze and release packaging components.
	 	 	 	X
	 
	 	 	 	 	 	 
	11.

	 	Maintain records and evidence on the testing of
packaging/labelling materials for five years after the
materials were last used in the packaging/labelling of the
Product(s).
	 	 	 	X
	 
	 	 	 	 	 	 
	12.

	 	Document, investigate and resolve any deviation from
approved packaging instructions or specifications.
	 	 	 	X

- 6 -

 

Quality Agreement: February 1, 2006

	 	(f)	 	Testing & Release of Finished Product

	 	 	 	 	 	 	 
	 	 	 	 	Client	 	Patheon
	1.

	 	Provide finished product specifications.
	 	X	 	 
	 
	 	 	 	 	 	 
	2.

	 	Supply / develop analytical test methods for finished
product.
	 	X
	 	(X)
	 
	 	 	 	 	 	 
	3.

	 	Test finished product.
	 	 	 	X
	 
	 	 	 	 	 	 
	4.

	 	Maintain all batch records for a minimum of one year past
Product(s) expiry date and supply copies of all such records to
the Client upon request.
	 	 	 	X
	 
	 	 	 	 	 	 
	5.

	 	Notify Client QA of Out-Of-Specification results within
one business day of confirmation.
	 	 	 	X
	 
	 	 	 	 	 	 
	6.

	 	Retain reference samples of finished product for one year
past expiration date.
	 	 	 	X
	 
	 	 	 	 	 	 
	7.

	 	Retain reserve sample of finished product as required by
21 CFR 211.170(b)(1).
	 	 	 	X
	 
	 	 	 	 	 	 
	8.

	 	Release finished product to Client and provide C of A.
	 	 	 	X

	 	(g)	 	Stability Testing (if required)

	 	 	 	 	 	 	 
	 	 	 	 	Client	 	Patheon
	1.

	 	Provide stability testing protocol for finished Product(s).
	 	(X)
	 	X
	 
	 	 	 	 	 	 
	2.

	 	Store stability samples.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.

	 	Develop and validate stability indicating assay.
	 	 	 	X
	 
	 	 	 	 	 	 
	4.

	 	Perform stability testing.
	 	 	 	X
	 
	 	 	 	 	 	 
	5.

	 	Notify the Client of any confirmed stability failure for
Product(s) supplied to the Client within one business day.
	 	 	 	X

- 7 -

 

Quality Agreement: February 1, 2006

ARTICLE 2

COMPLIANCE BETWEEN PRODUCT REGISTRATION AND THE

MANUFACTURING PROCESS

	2.1	 	Technical Changes

	 	(a)	 	In accordance with Patheon Standard Operating Procedures, Patheon will communicate
all proposed process changes to the Client for prior review and written approval; the
Client’s approval will not be unreasonably withheld. The Client will determine whether to
initiate registration variation procedures and will maintain adequate control over the
quality commitments of the marketing authorization for Product(s).
	 
	 	(b)	 	After validation of a process change and at Client’s request, Patheon will deliver a
copy of the validation report and the associated stability data, if applicable, to the
Client.

	2.2	 	Labelling / Packaging Material Changes
	 
	 	 	The Client may initiate changes and will review and approve any changes proposed by Patheon
to labelling or primary packaging, including a change in the supplier of any labelling or
primary packaging materials, before any such change occurs.
	 
	2.3	 	Other Changes
	 
	 	 	Patheon will communicate any proposed changes in storage or shipping to the Client for
prior review and written approval; the Client’s approval will not be unreasonably withheld.
Patheon will also inform the Client of any planned changes in facilities or equipment
directly related to the Product(s).
	 
	2.4	 	Regulatory Approvals
	 
	 	 	The Client will obtain and/or maintain all regulatory approvals for the Products and the
Specifications, including, without limitation, all marketing and post-marketing approvals.
	 
	2.5	 	Field Alerts and Recalls
	 
	 	 	The Client will notify Patheon before filing any NDA Field Alert or initiating a Recall
related to the Product(s). Patheon and the Client will work together to assure the accuracy
of any NDA Field Alert or Recall related to the Product(s). The Client will have final
authority to initiate a Product Recall or an NDA Field Alert.

- 8 -

 

Quality Agreement: February 1, 2006

ARTICLE 3

BATCH RELEASE

	3.1	 	Batch review and release to the Client will be the responsibility of Patheon who shall act
in accordance with Patheon’s standard operating procedures. The Client will have sole
responsibility for release of the Product(s) to the market.
	 
	3.2	 	For each batch released by Patheon for shipment to the Client, Patheon will deliver to the
Client a certificate of analysis (C of A)/certificate of compliance (C of C), which will
include a statement that the batch has been manufactured in accordance with cGMPs and the
Specifications.
	 
	3.3	 	Patheon will notify the Client in the event of (i) any major deviation during manufacture
which affects the quality or efficacy of the Product(s) or (ii) a
confirmed out of specification (OOS) result. Patheon will provide a copy of the deviation
investigation and/or OOS investigation report upon request.

ARTICLE 4

BATCH DOCUMENTATION

	4.1	 	Patheon will retain originals of all batch documentation for one year past the expiry date
of the Product(s), or longer if required by law, after which Patheon shall provide written
notice to the Client and offer the Client the opportunity to take possession of such
documents. If the Client does not elect to take possession within 45 days of Patheon’s notice,
Patheon may destroy such documents.
	 
	4.2	 	At the request of the Client, Patheon will provide a copy of any of the executed batch
documents relating to Product(s) to the Client within two Business Days.

ARTICLE 5

STABILITY

	5.1	 	Patheon will perform such stability testing as described in a stability protocol developed
by Patheon and agreed to in writing by the Client.
	 
	5.2	 	If a confirmed result indicates that a Product(s) failed to remain within stability
specifications, Patheon will notify the Client within one Business Day.

	5.3	 	Patheon will provide stability data to the Client on an ongoing basis as agreed to by both
parties.

- 9 -

 

Quality Agreement: February 1, 2006

	5.4	 	If the MSA is terminated, Patheon will continue to provide the Client with stability data
supporting the acceptability of the Product(s) until the Product(s) distributed by the Client
reaches the end of its shelf life or such other date as may be required by applicable law.

ARTICLE 6

VALIDATION

	6.1	 	With assistance from Patheon, Client will ensure that analytical methods and manufacturing
and packaging procedures for the Product(s) are validated.
	 
	6.2	 	Patheon is responsible for executing the approved validation protocols.

ARTICLE 7

GENERAL

	7.1	 	Any communications required under this Agreement will be directed to the person(s)
identified in Schedule B.
	 
	7.2	 	Capitalized terms not otherwise defined herein will have the meaning specified in the MSA.
	 
	7.3	 	If any the terms of this Quality Agreement and the terms of the MSA conflict, the terms of
the MSA will govern.
	 
	7.4	 	Any modification, amendment or supplement to this Quality Agreement must be in writing and
signed by authorized representatives of Patheon and the Client.

- 10 -

 

Quality Agreement: February 1, 2006

	 	 	 	 	 	 	 	 	 	 	 
	SOMAXON PHARMACEUTICALS, INC.	 	PATHEON PHARMACEUTICALS INC.
	 
	 	 	 	 	 	 	 	 	 	 
	Name:

	 	Doranne Frano
	 	Name:
	 	Jack Domet	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Signature :

	 	/s/ Doranne Frano

	 	Signature:
	 	/s/ Jack Domet
	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Title:

	 	Sr. Director, Regulatory &
	 	Title:
	 	Director, Quality Operations	 	 	 	 
	 

	 	Quality Assurance	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Date:

	 	Feb 1, 2006
	 	Date:
	 	2/2/2006	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 		 	 	 	 

- 11 -

 

Quality Agreement: February 1, 2006

SCHEDULE A

PRODUCT(S)

	 	 	 	 	 
	Product(s)	 	Dosage Form	 	Dosage (Strength)
	 
	Doxepin

	 	  [***]
	 	     [***] mg
	 
	 	 	 	 
	Doxepin

	 	  [***]
	 	     [***] mg
	 
	 	 	 	 
	Doxepin

	 	  [***]
	 	     [***] mg

 

			
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treatment has been requested with respect to the omitted portions.

- 12 -

 

Quality Agreement: February 1, 2006

SCHEDULE B

QUALITY CONTACTS

	 	 	 
	[***]
	 	 
	 
	 	 
	[***]

	 	[***]
	 
	 	 
	[***]

	 	[***]
	 
	 	 
	[***]

	 	[***]
	 
	 	 
	[***]

	 	[***]
	 
	 	 
	[***]

	 	[***]
	 
	 	 
	 
	 	 
	[***]
	 	 
	 
	 	 
	[***]

	 	[***]
	 
	 	 
	[***]

	 	[***]
	 
	 	 
	[***]

	 	[***]
	 
	 	 
	[***]

	 	[***]
	 
	 	 
	[***]

	 	[***]

[***]

 

			
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separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.

- 13 -

 

Patheon Cincinnati Quality Agreement: Last Revision January 17, 2006

SCHEDULE C

PATHEON APPROVED SUPPLIER LIST

	 	 	 	 	 	 
	Excipient	 	 	 	Supplier	 
	[***]

	 	[***]
	 	[***]	 
	 
	 	 	 	 	 
	[***]

	 	[***]
	 	[***]	 
	 
	 	 	 	 	 
	[***]

	 	[***]
	 	[***]	 
	 
	 	 	 	 	 
	 
	 	 	 	 	 
	[***]

	 	[***]
	 	[***]	 
	 
	 	 	 	 	 
	[***]

	 	[***]
	 	[***]	 
	 
	 	 	 	 	 
	[***]

	 	[***]
	 	[***]	 

 

			
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separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.

- 14 -

 

Patheon Cincinnati Quality Agreement: Last Revision January 17, 2006

SCHEDULE D

CLIENT APPROVED SUPPLIER LIST

Doxepin HC1 [***]

 

			
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treatment has been requested with respect to the omitted portions.

- 15 -

 

Patheon Cincinnati Quality Agreement: Last Revision January 17, 2006

Abbreviations and Definitions

	 	 	 
	API

	 	Active Pharmaceutical Ingredient
	 
	 	 
	BSE

	 	Bovine Spongiform Encephalopathy
	 
	 	 
	C of A

	 	Certificate of Analysis
	 
	 	 
	C of C

	 	Certificate of Compliance
	 
	 	 
	CFR

	 	Code of Federal Regulations
	 
	 	 
	CGMP/GMP

	 	Current Good Manufacturing Practice as described in
21 CFR 210 and 211.
	 
	 	 
	FDA

	 	Food & Drug Administration
	 
	 	 
	IQ

	 	Installation Qualification
	 
	 	 
	MSA

	 	Manufacturing Services Agreement
	 
	 	 
	NDA

	 	New Drug Application
	 
	 	 
	OOS

	 	Out of Specification
	 
	 	 
	OQ

	 	Operational Qualification
	 
	 	 
	Primary Packaging Materials

	 	A component that is or maybe in direct contact with
the dosage form
	 
	 	 
	TSE

	 	Transmissible Spongiform Encephalopathy

- 16 -

 

SCHEDULE I

PRODUCT BILL OF MATERIALS 

Product Name: DOXEPIN [***] MG TABLETS — [***]

Product Code: [***]

Theoretical Batch Size: [***]

Formula:

	 	 	 
	[***]	 	[***]
	[***]
	 	[***]
	[***]
	 	[***]
	[***]
	 	[***]
	[***]
	 	[***]
	[***]
	 	[***]
	[***]
	 	[***]

 

			
	***	 	Certain information on this page has been omitted and filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.

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