Document:

Exhibit 10.1

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

LICENSE, SUPPLY, MARKETING, DISTRIBUTION

 

AND COLLABORATION AGREEMENT

 

By and Between

 

UPSHER-SMITH LABORATORIES, INC.

 

and

 

ORION CORPORATION

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

TABLE OF CONTENTS

 

	
1
    	
DEFINITIONS
    	
1
    
	
2
    	
GRANT AND   SCOPE OF RIGHTS
    	
9
    
	
3
    	
OVERSIGHT   COMMITTEE
    	
10
    
	
4
    	
DEVELOPMENT   OF PRODUCT
    	
10
    
	
5
    	
UP-FRONT   AND MILESTONE PAYMENTS
    	
15
    
	
6
    	
TERMS AND   CONDITIONS — PRODUCT SUPPLY, PAYMENTS AND ROYALTIES
    	
17
    
	
7
    	
USL’S   DILIGENCE OBLIGATIONS REGARDING COMMERCIALIZATION
    	
26
    
	
8
    	
REGULATORY   MATTERS
    	
27
    
	
9
    	
SAMPLES
    	
31
    
	
10
    	
MARKETING, ADVERTISING AND PROMOTIONAL EFFORTS FOR PRODUCT
    	
31
    
	
11
    	
COMPETING PRODUCT
    	
32
    
	
12
    	
TRADEMARKS
    	
33
    
	
13
    	
PATENT OWNERSHIP AND PROSECUTION
    	
35
    
	
14
    	
PATENT INFRINGEMENT MATTERS
    	
36
    
	
15
    	
LIAISON AND REPORTS - MARKETING AND SALES REPORTS, FORECASTS
    	
38
    
	
16
    	
PRODUCT SPECIFICATIONS, QUALITY, WARRANTIES, INDEMNITIES
    	
38
    
	
17
    	
CONFIDENTIALITY
    	
44
    
	
18
    	
FORCE MAJEURE
    	
45
    
	
19
    	
SEVERABILITY OF CLAUSES
    	
46
    
	
20
    	
RIGHT TO EARLIER TERMINATION
    	
46
    
	
21
    	
21 NOTICES
    	
52
    
	
22
    	
INTEGRATION CLAUSE
    	
52
    
	
23
    	
COUNTERPARTS
    	
52
    
	
24
    	
ASSIGNMENT
    	
53
    
	
25
    	
GOVERNING LAW AND DISPUTE RESOLUTION
    	
53
    
	
26
    	
TERM OF AGREEMENT
    	
55
    
	
27
    	
INDEPENDENT CONTRACTOR STATUS OF PARTIES
    	
55
    
	
28
    	
REPRESENTATIONS AND WARRANTIES - GENERAL
    	
55
    
	
29
    	
LANGUAGE
    	
57
    
	
30
    	
NON-WAIVER CLAUSE
    	
57
    
	
31
    	
HEADINGS
    	
57
    
	
32
    	
PUBLICITY
    	
57
    
	
33
    	
NO THIRD PARTY BENEFICIARIES
    	
58
    
	
SCHEDULE 1
    	
59
    
	
SCHEDULE 2
    	
60
    
	
SCHEDULE 3
    	
61
    
	
SCHEDULE 4
    	
63
    
	
SCHEDULE 5
    	
66
    

 

i

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

This License, Supply, Marketing, Distribution and Collaboration Agreement (hereinafter called the “Agreement”) is made and entered into as of November 24, 2003 (hereinafter “Date of Agreement”) by and between Orion Corporation, a company duly organized and existing under the laws of Finland and having its principal offices at Orionintie 1, (P.O. Box 65), 02200 Espoo, Finland (hereinafter “Orion”), and Upsher-Smith Laboratories, Inc., a company duly organized and existing under the laws of Minnesota and having its principal office at 6701 Evenstad Drive, Maple Grove, Minnesota, USA (hereinafter “USL”). Orion and USL may also be described individually as “Party” or collectively as “Parties”.

 

Whereas, USL desires to obtain a license from Orion, and Orion is willing to grant a license to USL, for the Product (as herein below defined) in the Territory (as herein below defined), all in accordance with and subject to the terms and conditions of this Agreement.

 

NOW THEREFORE,

 

Orion and USL hereby agree as follows:

 

1                                                            DEFINITIONS

 

Unless otherwise specified below, the following terms shall carry their respective meanings for purposes of this Agreement

 

“Act” shall mean the U.S. Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder.

 

“Affiliate” shall mean any business entity controlled by a Party, or which controls a Party, or which is under common control with a Party. For purposes of this definition, control means the direct or indirect ownership of fifty percent (50%) or more of the authorized issued voting shares or other voting interest in such entity, or such other relationship, including those under which the ownership interest is less than 50%, as in fact allows a Party to exercise effective control over the management, business and affairs of such entity or Party, as the case may be. The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management and policies of such entity.

 

“Agent” shall mean any Third Party that, subject to Section 2.2, may be utilized by USL or its Affiliate(s) in the Territory to commercialize Product therein on behalf of and for the account of USL or its Affiliate(s) in accordance with this Agreement.

 

“Applicable Consequential Damages Cap” has the meaning set forth in Section 16.13 below.

 

“Business Day” means a day on which banking institutions in Minneapolis, Minnesota and Helsinki, Finland are open for business.

 

“Clinical Supply Cost” shall mean the sum of (a) the cost of Product and placebos of Product utilized in activities in accordance with the Development Plan, as determined in accordance with Section 4.8, (b) out-of-pocket costs and expenses incurred in purchasing comparator drug and in packaging comparator drug and/or the Product and/or placebos of Product, shipping clinical supplies to centers and/or disposal of clinical supplies, and (c) actual costs of packaging comparator and Product if done by USL or Orion.

 

“Competing Product” shall mean [***]

 

1

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

“Compound” shall mean estradiol hemihydrate.

 

“Confidential Information” means all proprietary materials, know-how or other information (whether or not patentable) regarding a Party’s technology, products, business information or objectives, which is designated as confidential in writing by the disclosing Party, whether by letter or by the use of an appropriate stamp or legend, prior to or at the time any such material, know-how or other information is disclosed by the disclosing Party to the other Party or its Affiliate. Notwithstanding the foregoing to the contrary, proprietary materials, know-how or other information which is orally, electronically or visually disclosed by a Party, or is disclosed in writing without an appropriate letter, stamp or legend, shall constitute Confidential Information of the disclosing Party only if, (a) the disclosing Party, within thirty (30) days after such disclosure, delivers to the other Party a written document or documents describing the materials, know-how or other information identifying same as confidential and referencing the place and date of such oral, visual, electronic or written disclosure and the names of the persons to whom such disclosure was made, or (b) such information is of the type that is customarily considered to be and is otherwise held as confidential information by the disclosing Party. In addition, any technical or financial information of a Party disclosed at a meeting of the Oversight Committee or any subcommittee thereof or disclosed through any report provided, or audit conducted, pursuant to this Agreement shall constitute Confidential Information of the disclosing, reporting or non-auditing Party, as applicable, unless otherwise specified. The terms of this Agreement shall be considered Confidential Information of each Party.

 

“Control” or “Controlled” means with respect to any (a) material, item of information, method, data or other know-how, or (b) intellectual property right, in each case the possession of which (whether by ownership or license, or other contractual right other than pursuant to this Agreement) by a Party or its Affiliates allows a Party the ability to grant to the other Party access to and/or a license as provided herein under such item or right without violating the terms of any agreement or other arrangement with any Third Party existing before or after the Date of Agreement

 

“Development” or “Develop” shall mean, pre-clinical and clinical drug development activities, including, among other things, pharmacology, pharmaceutical development, toxicology, statistical analysis and report writing, Phase I Studies, Phase HA Studies, Phase JIB Studies, Phase HIA Studies, Phase MB Studies, FDA-required Phase IV Studies, Independent pre-clinical and clinical Quality Assurance and Audit activities, product approval and registration and regulatory affairs activities, related to the foregoing. When used as a verb, ‘Develop” means to engage in Development.

 

“Development Cost” means, for all studies or activities performed in accordance with a Development Plan for the Development of Product, (a) all out-of-pocket costs and expenses incurred (i.e., paid to Third Parties or accrued and payable to Third Parties) by USL or Orion or their Affiliates, (b) the Party Internal Development Cost of such studies or activities, and (c) the Clinical Supply Cost of such studies or activities. Notwithstanding the foregoing, Development Costs shall not include any costs or expenses incurred in connection with manufacturing process development and validation, manufacturing scale-up, stability testing, or quality assurance/quality control development for the Product. Without limiting the foregoing, among the costs excluded from the definition of “Development Costs” are the following (which shall be borne by Orion): (1) the costs for manufacture of three (3) NDA lots of each strength or dosage of the Product; and (2) the costs for validation, stability testing, and quality assurance and quality control development for the Product

 

“Development Plan” shall mean the pre-clinical, clinical and pharmaceutical development plan for Product, which sets forth the activities, timetable and budget for the Development of Product in the Field, including the Initial Development Plan attached to this Agreement, as such plan may be amended from time to time in accordance with the terms of this Agreement.

 

2

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

“FDA” shall mean the United States Food and Drug Administration or any successor agency thereof whose approval is necessary to lawfully offer for sale, sell or market Product in the United States.

 

“Field” shall mean treatment of vasomotor symptoms and vulvar and vaginal atrophy in] women.

 

“First Commercial Sale” shall mean the first shipment of commercial quantities of any Product sold on arm’s length terms to a Third Party by USL or its Affiliates or sublicensees in the Territory after Regulatory Approval has been obtained for such Product. Sales for test marketing, sampling and promotional uses, clinical trial purposes or compassionate or similar use shall not be considered to constitute a First Commercial Sale.

 

“First Year” shall mean the period extending from the First Commercial Sale in the United States through December 31 of the year of the First Commercial Sale as well as the entire following Year.

 

“Improvements” means any subsequent developments in or with respect to the Product developed (whether alone or jointly with another party), owned, possessed, Controlled or acquired by Orion, including without limitation all Inventions, ideas, know-how, information, discoveries, improvements, enhancements, modifications, progeny, new indications and concepts that relate to the Product, it being understood that the only rights with respect to “Improvements” granted under this Agreement to USL are as stated in Section 2 of this Agreement.

 

“Initial Development Plan” shall mean the initial development plan for the Product, as outlined in Schedule 2 attached hereto.

 

“Inventions” mean inventions, developments, original works of authorship, concepts, improvements, and trade secrets, whether or not patented or patentable, or registered or registerable under patent, copyright, trademark or similar laws, conceived, developed, or reduced to practice, or caused to be conceived, developed, or reduced to practice, in conjunction with, or which involve or relate to, the use, formulation, testing or manufacture, of the Product, it being understood that the only rights with respect to “Inventions” granted under this Agreement to USL are as stated in Section 2 of this Agreement.

 

“Net Sales” shall mean the gross revenues accrued or invoiced (but with any one sale being counted only once) by USL, its Affiliates or sublicensees (other than Third Party private label distributors) (determined on an accrual basis in accordance with United States generally accepted accounting principles consistently applied (“USGAAP”)) from sales of Product in the Territory to Third Parties in bona fide, arms-length transactions, less the following deductions (which shall be verifiable by other appropriate documentation relating directly or on a pro rata basis thereto):

 

(i)                                     an allowance for bona fide transportation, distribution and shipping costs, insurance costs and importation charges (including duties attributable to import and re-sale of Product by USL or its Affiliates or Agents), which shall be equivalent to USL’s standard internal charge for such costs that is applied to all of its other products;

 

(ii)                                  sales, excise, turnover, inventory, value added or similar taxes, levied against and payable by USL or its Affiliates or Agents directly on account of the Product’s import or re-sale to its customers in the Territory (including without limitation VAT taxes) and custom duties;

 

(iii)                               (a) trade, quantity or cash discounts and (b) rebates or charge-backs to the extent actually allowed, given or accrued and payable to Third Parties for

 

3

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Product, including but not limited to cash, governmental and managed care rebates and hospital or other buying group charge-backs (in each case described in (a) and (b) in the ordinary course of USL’s business, consistent with prior practice for other pharmaceuticals sold by USL);

 

(iv)                              amounts repaid or credited to customers by reason of rejections or returns of Product;

 

(v)                                 that portion of any management fees paid by USL or its Affiliates to group purchasing organizations that relate specifically to the sale of Product by USL or its Affiliates or Agents to such organizations; and

 

(vi)                              interest, service, finance or sales carrying charge paid by customers for extension of credit on sales.

 

For the purpose of this definition Third Parties shall mean the usual and customary customers for pharmaceutical products such as Product, including, without limitation, Third Party private label distributors, wholesalers, hospitals, HMOs, pharmacies, managed care organizations and other customers for pharmaceutical products in the Territory, who purchase Product from USL, its Affiliates or Agents, as applicable, for sale or dispensing to patients.

 

“Orion Patent” shall mean (a) the Patent Rights owned or controlled by Orion pending as of the Date of this Agreement, which are all of Orion’s Patent rights, and are listed in Schedule 1 attached hereto, and (b) any and all Patent Rights hereafter owned or controlled by Orion while USL has rights with respect to the Product under this Agreement.

 

“Orion Proprietary Information” shall mean (i) all Confidential Information owned or Controlled by Orion or its Affiliates, either prior to or following the Date of Agreement, and held, treated or designated as confidential or held as a trade secret by Orion or its Affiliates and not generally available to the public, whether or not patented or patentable, relating to Product, and (ii) any documentation and information generated by or for Orion or any Orion Affiliate and owned or Controlled by Orion or its Affiliate(s), or legally received from Orion’s licensor(s) and/or other sources and Controlled at any time by Orion or its Affiliate(s) relating to Product, including without limitation, all physical, chemical, pharmaceutical, pre-clinical, clinical, analytical, formulation, stability, production and performance data and information, including but not limited to (a) documentation, data, and other information concerning Product supplied or provided by Orion, directly or indirectly (by cross reference to information owned or Controlled by Orion) to Regulatory Authorities in the Territory and/or to USL on a confidential basis for purposes of or in connection with any Product NDA or other regulatory filing relating to Product, and all communications with regulatory agencies with respect to the Product (whether inside the Territory or outside the Territory), including without limitations correspondence and minutes of meetings with all such regulatory agencies, and (b) that which is Developed by Orion or for Orion’s account or benefit by any Third Party in connection with this Agreement. Notwithstanding anything contained herein to the contrary, Orion Proprietary Information shall not include any documentation, data, or information listed in the preceding sentence to the extent such was developed, paid for or reimbursed by USL in accordance with the terms of this Agreement, it being agreed that such items of documentation, data or information developed by or on behalf of USL or paid for or reimbursed by USL shall be “USL Data” and shall be Confidential Information of USL.

 

“Party Internal Development Cost” shall mean the product of (a) number of scientific, technical or managerial work on or directly related to the Development of Product of a Party or any of their Affiliates, as the case may be, utilized to perform activities in accordance with the Development Plan or otherwise

 

4

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

based on this Agreement, and (b) the Party Internal Development Rate; provided, further, that it is understood that costs associated with representation on, and participation in, any committee or project team, and travel time, under this Agreement shall not be charged as a Party Internal Development Cost.

 

“Party Internal Development Rate” shall mean with respect to either Party [***] per hour with respect to USL and [***] with respect to Orion in the calendar year 2003, increased each subsequent Year by the percentage increase, if any, between (a) with respect to USL, the Consumer Price Index — All Urban Consumers (CPI-U), as published by the United States Department of Labor at June 30 of the prior Year compared to June 30 of the second immediately preceding Year., and (b) with respect to Orion, the Consumer Price Index in Finland (published by the government’s “Center for Statistics” = Statistics Finland; “Tilastokeskus”), or any successor index thereto, at June 30 of the prior Year compared to June 30 of the second immediately preceding Year.

 

The Party Internal Development Rate in the case of both USL and Orion is inclusive of direct and indirect costs such as salary, overtime, benefits and other personnel costs; general laboratory supplies; laboratory space; office supplies; IS hardware and software; maintenance and repairs; communications; and travel and entertainment. Such normal and recurring costs included in the Party Internal Development Rate will not be separately billed as out-of-pocket costs in any cost sharing determination.

 

“Patent Rights” shall mean United States patents and patent applications, including any continuations, continuations-in-part, divisions, provisionals or any substitute applications, any patent issued with respect to any such patent application, any reissue, re-examination, renewal or extension (including any supplementary protection certificate) of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent claiming Inventions related to the Product now or hereafter owned or Controlled by either party.

 

“Product” shall mean the following pharmaceutical preparations that contain or comprise Compound as sole active ingredient. The dosage forms of the formulation agreed for both development and commercialization are as follows: [***] sachet of Product equal to [***] of Compound, and [***] sachet of Product equal to [***] of Compound each of formulation EF108; as further Developed pursuant to this Agreement. The parties also agree currently that a dosage form and strength of a to be determined sachet of Product equal to [***] of Compound will be developed and may or may not be commercialized, and that a dosage form and strength of [***] sachet of Product equal to [***] of Compound may or may not be developed and if developed may or may not be commercialized (as will be determined by USL after consultation with Orion, with the understanding that any work required under the then current Development Plan for the development and/or commercialisation of said dosage forms and strengths that requires incremental expenditures compared to the manufacturing capacity of Orion existing as of the Date of Agreement, shall be reimbursed by USL to Orion at Orion’s Party Internal Development Rate for work performed by Orion, or at Orion’s out of pocket cost for work performed by a qualified independent contractor as contemplated in, and subject to, Section 4.4.3(a)). The Product shall also include such additional dosage forms or strengths of Product that may eventually be approved by applicable Regulatory Authorities, should Regulatory Approval for any additional or other dosage form(s) or strengths of Product be sought during the Term pursuant to this Agreement.

 

“Product NDA” shall mean the New Drug Application (“NDA”) to be filed with the FDA seeking approval of the Product (or any subsequent NDA filed with the FDA for any other strength, dosage or indication for the Product not included in the first NDA for the Product) for marketing, sale and use in the Field in the United States.

 

5

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

“Quality Assurance Agreement” shall mean the agreement to be entered into by the Parties specifying certain terms and conditions relating to the manufacture of Product by Orion for USL, or USL for Orion pursuant to any exercise by USL of its back-up manufacturing rights under this Agreement.

 

“Regulatory Approval” shall mean any and all approvals (including any applicable governmental price and reimbursement approvals), licenses, registrations, or authorizations of any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity necessary for the manufacture, use, storage, import, export, transport, promotion, marketing and sale of Product in the Territory.

 

“Regulatory Authority” shall mean such governmental department, bureau, commission, agency, or other regulatory authority which has responsibility for regulating activities involving pharmaceutical products, including the review and issuance of Regulatory Approvals in the Territory.

 

“Samples” shall mean Product supplied to USL by Orion in accordance with this Agreement for distribution by USL and its Affiliates and/or Agents in the Territory to health care professionals for dispensing, in turn, to patients for “trial use” at no cost to the patient pursuant to applicable laws and regulations. Samples are not intended for re-sale and shall not be included in the calculation of Net Sales in connection with this Agreement.

 

“Specifications” shall mean and include those agreed initial specifications and parameters for Product set forth or referenced in Schedule 3 hereto, as the same shall be modified upon the mutual written agreement of the Parties in accordance with the provisions of Section 163, and as approved by the FDA.

 

“Term” means the duration that this Agreement shall remain in effect, unless earlier terminated in accordance with its terms. The “Term” shall mean the time period beginning on the Date of Agreement and ending on the date corresponding to the tenth (10th) anniversary thereof. However, if written notification of approval of the first Product NDA for the Product in the United States is received later than the date estimated for receipt of such approval in the Initial Development Plan, and the delay is due to USL’s failure to perform in accordance with the timelines set forth in the Initial Development Plan, the Term shall be extended by the number of days of such delay in receipt of the Product NDA approval (it being understood that the Term shall not be extended in this manner to the extent such delay is due to Orion’s failure to perform in accordance with the timelines set forth in the Initial Development Plan).

 

“Territory” shall mean the United States of America, its fifty states and District of Columbia, and its territories and possessions, as well as Canada.

 

“Third Party” shall mean any person or entity other than a Party or any of its Affiliates unless otherwise provided for in this Agreement.

 

“Trademark” shall mean a trademark selected, registered or registerable, and owned by Orion or USL as stipulated for under Section 14 hereof to be used for Product in the Territory.

 

“USL Data” shall have the meaning set forth in Section 4.6.

 

“Year” shall mean a period of twelve (12) consecutive months from 1st January to 31st December, except in the case of the “First Year” which is defined above.

 

The following Schedules are being simultaneously delivered with the execution of this Agreement. All such Schedules shall be deemed to form an integral part of this Agreement and are incorporated herein by reference.

 

6

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Schedule 1 Orion Patents

Schedule 2 Initial Development Plan

Schedule 3 Initial Specifications for Product

Schedule 4 Manufacturing Cost Principles

Schedule 5 Pharmacovigilance

 

Additional Definitions. Each of the following definitions is set forth in the Section of this Agreement indicated below:

 

	
Definition
    	
 
    	
Section
    
	
“Acceptance”
    	
 
    	
5.3
    
	
“Applicable Consequential Damages Cap”
    	
 
    	
16.13
    
	
“Applicable Percentage”
    	
 
    	
6.9
    
	
“Applicable Period”
    	
 
    	
14.2(a)
    
	
“Budget”
    	
 
    	
8.3
    
	
“CGMPs”
    	
 
    	
4.5
    
	
“CMC”
    	
 
    	
4.4.3(a)
    
	
“Contractual Third Party”
    	
 
    	
16.13
    
	
“Date of Agreement”
    	
 
    	
Preamble
    
	
“Dealing with a Competing Product”
    	
 
    	
11.1
    
	
“Defaulting Party”
    	
 
    	
21.2.1
    
	
“DMF”
    	
 
    	
8.6
    
	
“FAMC”
    	
 
    	
Schedule 4
    
	
“Final Study Report”
    	
 
    	
4.6.3(a)
    
	
“Finnish GAAP”
    	
 
    	
6.12(b)
    
	
“First Milestone Payment”
    	
 
    	
5.3
    
	
“GCPs”
    	
 
    	
4.5
    
	
“GLPs”
    	
 
    	
4.5
    
	
“Incoterms 2000”
    	
 
    	
6.7
    
	
“INDs”
    	
 
    	
8.3
    
	
“Initial Forecast”
    	
 
    	
6.2(a)
    
	
“Know-how Royalty”
    	
 
    	
6.9
    
	
“Licenses”
    	
 
    	
2.1
    
	
“Minimum Net Sales”
    	
 
    	
7.2
    
	
“NDA”
    	
 
    	
Definition of “Product NDA”
    
	
“Net Sales Shortfall”
    	
 
    	
7.3
    
	
“Non-Defaulting Party”
    	
 
    	
21.2.1
    

 

7

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
“Non-Prosecuting Party”
    	
 
    	
13.2
    
	
“Notice of Refusal to File”
    	
 
    	
5.3
    
	
“00S”
    	
 
    	
16.5
    
	
“Orion”
    	
 
    	
Preamble
    
	
“Orion Indemnified Persons”
    	
 
    	
16.10(a)
    
	
“Oversight Committee”
    	
 
    	
3.1
    
	
“Paragraph IV Certification Notice”
    	
 
    	
14.1(c)
    
	
“Party” or “Parties”
    	
 
    	
Preamble
    
	
“Phase IV”
    	
 
    	
4.8
    
	
“Producer Price Index for Manufactured
    	
 
    	
 
    
	
Product in Finland”
    	
 
    	
6.12(a)
    
	
“Product Manufacturing Know-How”
    	
 
    	
6.5(b)
    
	
“Projected Sales Level Statement”
    	
 
    	
7.2
    
	
“Prosecuting Party”
    	
 
    	
13.2
    
	
“Purchase Orders”
    	
 
    	
63(a)
    
	
“Quality Assurance Unit”
    	
 
    	
16.4
    
	
“Required Post Approval Studies”
    	
 
    	
4.4.3(c)
    
	
“Rolling Two Year Forecast”
    	
 
    	
6.2(c)
    
	
“Routine Forecast”
    	
 
    	
6.2(b)
    
	
“Safety Data”
    	
 
    	
4.6.4
    
	
“Sample Price”
    	
 
    	
9.1(a)
    
	
“Second Milestone Payment”
    	
 
    	
5.4
    
	
“Shortfall Royalty”
    	
 
    	
7.3
    
	
“Sublicensee Fees”
    	
 
    	
5.6
    
	
“Supply Price”
    	
 
    	
6.8
    
	
“Third Milestone Payment”
    	
 
    	
5.5
    
	
“Third Party Agreement”
    	
 
    	
21.3.2
    
	
“Up-Front Signing Fee”
    	
 
    	
5.2
    
	
“USGAAP”
    	
 
    	
Definition of
    
	
“NetSales”
    	
 
    	
 
    
	
“USL”
    	
 
    	
Preamble
    
	
“USL Data”
    	
 
    	
4.6.3
    
	
“USL Indemnified Persons”
    	
 
    	
16.11(a)
    

 

8

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

2                                                            GRANT AND SCOPE OF RIGHTS

 

2.1                                                  License. Subject to the terms and conditions of this Agreement, Orion hereby grants to USL the exclusive rights and licenses in the Field during the Term (and thereafter, subject to the terms of this Agreement) under Orion Patents and Orion’s Proprietary Information to:

 

(a)                                 undertake further Development of Product in accordance with this Agreement;

 

(b)                                 file and pursue Regulatory Approval’s for Product in the Territory;

 

(c)                                  import, offer to sell, advertise, market, promote, sell, and distribute Product in the Territory under the Trademark;

 

(d)                                 make and have made Product which Orion does not manufacture pursuant to the provisions of Sections 6.5, 6.6 and 20.

 

All such rights and licenses are collectively referred to herein as the “Licenses”.

 

USL hereby accepts the Licenses granted to it herein above and agrees to perform its obligations according and subject to all terms and conditions of this Agreement. Orion agrees to perform its obligations under this Agreement according and subject to the terms and conditions hereof.

 

2.2                                                  Sub-Licenses. USL shall have the right to grant sublicenses under the Licenses in the Territory to its Affiliate(s) and Agents, provided that (1) each such sublicense is in the form of a written agreement consistent with the terms and conditions of this Agreement and (ii) with respect to any sublicense granted to an Agent, Orion has granted its prior written consent to USL, which consent shall not be unreasonably withheld. USL warrants that its Affiliates and Agents shall comply with all of the terms and conditions of this Agreement to the extent any of USL’s rights and duties hereunder are sublicensed to any such Affiliate(s) or Agent(s). Furthermore, USL shall remain jointly and severally liable with its licensed Affiliate(s) and Agent(s) for all undertakings assumed by USL under this Agreement as they apply to the sub-licensed territory. USL shall be responsible for complying and ensuring that its Affiliates and Agents, as applicable, comply with all relevant laws, regulations and requirements relating to the importation, packaging, distribution, marketing, promotion and sale and use of Product in the Territory. The Parties acknowledge and agree that a private label distributor is not an Agent or sublicensee hereunder, but shall be a Third Party. Nonetheless, USL’s grant of private label distribution to a Third Party, will be subject to Orion’s prior written consent as to the Third Party private label distributor, which consent shall not be unreasonably withheld. In all events requiring Orion’s consent under this Section 2.2, Orion shall be deemed to have given such consent unless, within twenty one (21) days after Orion’s receipt of notice from USL of an event requiring consent hereunder, Orion gives USL written notice stating that Orion is withholding its consent under this Section 2.2 and stating with specificity its reasons for withholding such consent.

 

2.3                                                  Manufacturing License. Except as provided in Sections 6.5, 6.6 and 20 herein below, and subject to the licenses granted to USL pursuant to Section 2.1(c), it is expressly understood and agreed that the grant of rights to USL under this Agreement excludes any rights whatsoever for USL or any of its Affiliates or Agents to manufacture any Product under any of the Orion Proprietary Information or Orion Patents.

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

2.4                                                  No Implied License. Any rights not expressly granted herein by Orion are expressly reserved and, accordingly, no rights or licenses other than those specified herein shall be deemed granted by this Agreement by implication, estoppel or otherwise.

 

2.5                                                  Future Developments. Orion will disclose to USL all Improvements relating to the Product which are invented, developed or otherwise acquired and Controlled by Orion during the Term of this Agreement. Upon USL giving Orion written notice accepting such Improvement the Improvement automatically be included within the scope of the Licenses granted to USL under this Agreement, and (as applicable) the definition of Product, Field, Orion Proprietary Information and/or Orion Patents, shall be deemed amended to add and incorporate such Improvement. Without limitation, any patents or patent applications which Orion may secure or file on or in conjunction with any such Improvements shall be added to the definition of Licensed Patents.

 

3                                                            OVERSIGHT COMMITTEE

 

3.1                                                  Oversight Committee. Promptly after Date of Agreement, but in any event within thirty (30) days from Date of this Agreement, the Parties shall establish an oversight committee (“Oversight Committee”) to oversee the Development of the Product to ensure timely development and approval of the Product. The Oversight Committee shall include up to four (4) representatives of each Party.

 

3.2                                                  Meetings. The Oversight Committee shall meet at least twice annually, unless otherwise agreed. Such meetings shall alternate between USL and Orion locations and be held at such times as are mutually agreed upon by the Oversight Committee. Some or all of each party’s representatives may participate in any meeting of the Oversight Committee by means of video or conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other.

 

3.3                                                  Decision Making. All decisions of the Oversight Committee shall be made by USL, after good faith consultation with Orion.

 

4                                                            DEVELOPMENT OF PRODUCT

 

4.1                                                  Collaboration Regarding Development. Following the Date of Agreement, the Development of Product for use in the Field in the Territory shall be carried out all in the manner agreed in this Agreement.

 

Orion shall have the unrestricted right to pursue Development of Product outside the Territory for use outside the Territory. Because Product inside the Territory developed for a use outside the Field would be interchangeable with Product developed and marketed by USL in the Territory for use in the Field (and would, as a practical matter, be inconsistent with the exclusive Licenses granted to USL under this Agreement for the Product in the Territory in the Field), Orion shall not, without USL’s written consent, directly or indirectly commence Development for the Territory of Product outside the Field.

 

4.2                                                  Designation of Lead Party for Product. USL shall serve as the lead Party for Development of Product.

 

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4.3                                                  Responsibility of USL; Collaboration, Cooperation and Assistance of Orion.

 

4.3.1                                        Subject to the terms and conditions of this Agreement, USL shall be responsible for performing all pre-clinical and clinical development of the Product in the Field that are required or useful (as USL determines) in order to obtain and maintain Regulatory Approvals for the Product in the Territory. USL shall perform all such activities in accordance with the Development Plan for the Product. Without limiting the generality of the foregoing, USL shall be responsible for:

 

(a)                                 the Development strategy and plan for the Product for inclusion in the Development Plan, as contemplated in this Agreement;

 

(b)                                 developing protocols for pre-clinical and clinical studies of the Product for the Territory;

 

(c)                                  conducting any pre-clinical and clinical studies in the Territory that are included in the Development Plan;

 

(d)                                 carrying out such Phase IV or other post marketing studies as USL deems necessary or appropriate, or as required by the FDA.

 

4.3.2                                        Orion shall provide such collaboration as is contemplated in the Development Plan and such cooperation and assistance in connection with the Development of the Product as is contemplated herein or in the Development Plan, or as USL shall reasonably request, all subject to the terms and conditions of this Agreement (including without limitation, subject to the terms of Section 4.4.3(a).

 

4.4                                                  Development Plan.

 

4.4.1                                        The Development Plan shall outline the overall strategy and plan for the Development of the Product in the Territory. The Development Plan shall be designed in a manner to generate sufficient pre-clinical and clinical data to support Product NDA. The Development Plan shall identify the specific indications in the Field for which the Product will be Developed and shall, on an indication-by-indication basis:

 

(a)                                 identify all major Development tasks remaining to be accomplished prior to submission of Product NDA;

 

(b)                                 identify key development objectives, expected associated resources, risk factors, timelines, so-called go/no go decision points and relevant decision criteria and, where appropriate, decision trees;

 

(c)                                  indicate, subject to the terms and conditions of this Agreement, how resources are expected to be provided to support the Development of the Product (including, without limitation, a budget for Development of the Product in accordance with the Development Plan); and

 

(d)                                 with respect to the Development of Product in the Field in the Territory, include a reasonably detailed description for the Development activities that are expected to be performed by the respective Parties pursuant to the terms hereof.

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

4.4.2                                        All Development of Product shall be conducted in accordance with the Development Plan. The Initial Development Plan is attached hereto as Schedule 2.

 

4.4.3                                        The Development Plan shall be updated, if necessary, and at least reviewed, on a regular basis. Subject to Sections 4.4.3(a) and (b) below, USL may, following good faith consultation with Orion, modify and amend the Development Plan, from time to time, in such a manner as necessary to respond to requests or suggestions by FDA related to the Development or registration of the Product, and to otherwise enable USL to try to meet such objective. Notwithstanding anything in this Agreement to the contrary:

 

(a)                                 Responsibility for all Development Costs that are related to the Development of the Product for or in the Territory shall be borne solely by USL, provided, however that Orion shall be solely responsible for the costs arising from the CMC development for Product within the scope of the Initial Development Plan up to the maximum limit of [***]. USL shall not, without Orion’s prior written consent, amend or modify the then current Development Plan in a manner that increases any financial obligation of Orion (whether for out-of-pocket expenses or internal expenses incurred) as set forth in the then current Development Plan that will not be reimbursed by USL to Orion using Orion’s Party Internal Development Rate (for work performed by Orion, or at Orion’s out of pocket cost for work performed by a qualified independent contractor as contemplated in, and subject to, this Section 4.4.3(a)). If USL modifies the Development Plan in a manner that requires Orion to undertake additional work not contemplated in the then current Development Plan, such additional work shall be reimbursed to Orion at Orion’s Party Internal Development Rate (for work performed by Orion, or at Orion’s out of pocket cost for work performed by a qualified independent contractor as contemplated in, and subject to, this Section 4.4.3(a)) and Orion may perform the work itself or engage qualified independent contractors reasonably acceptable to USL to perform some or all of the work (it being understood that the use by Orion of independent contractors shall not increase the budget authorized by USL for the work without USL’s prior written consent).

 

(b)                                 USL shall not have any obligation to modify the then current Development Plan (or undertake activities) in a manner that would involve USL incurring financial obligations (whether for out-of-pocket expenses (including without limitation, reimbursement of Orion) or internal expenses incurred) which exceed those in the then current Development Plan by more than [***] in the aggregate. If the FDA requires a change to the Development Plan in a manner that would involve USL incurring financial obligations (whether for out-of-pocket expenses (including without limitation, reimbursement of Orion) or internal expenses incurred) which exceed those in the then current Development Plan by more than [***] in the aggregate, that USL does not desire to make, Orion may assume responsibility and the financial obligation for such additional activities. In that event, USL will furnish reasonable assistance (at USL’s expense), as requested by Orion, to enable Orion (or its designee) to perform such additional work required by the FDA-required amendment, provided that if USL’s cost in furnishing such assistance (whether out-of-pocket expenses or internal expenses incurred) will exceed [***], then, instead of furnishing such assistance, USL may terminate this Agreement upon ninety (90) days prior written notice of termination to Orion.

 

(c)                                  Should the Product NDA for the Product be approved by the FDA subject to any post NDA approval conditions or requirements, for example, but not limited to a requirement

 

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or recommendation that the FDA be provided clinical “outcomes” or additional clinical study data or information as a condition for maintenance of such NDA approval (collectively, “Required Post Approval Studies”), then the Parties shall, subject to the terms of Sections 4.4.3(a) and (b) above, seek to agree in writing upon the manner in which such work shall be performed. As provided in Section 4.4.3(a) above, USL shall be solely responsible for any Development Costs incurred in connection with the performance of any Required Post Approval Studies, subject to Section 4.4.3(b) above.

 

(d)                                 As stated in Section 4.4.3(a) above, Orion shall not be responsible for Development Costs (which are not reimbursed by USL) beyond those stated in Section 44.3(a), without its prior written consent. USL shall not be responsible for expenses or costs of Orion or any independent contractor performing work on behalf of Orion not contained in a then current budget as a part of the then current Development Plan unless pre-authorized by USL in writing.

 

4.5                                                  Development Activities. The Parties shall use commercially reasonable efforts to conduct the Development activities each Party has agreed to assume under this Agreement and the Initial Development Plan. Each Party agrees to conduct Development activities under this Agreement in compliance with all laws and regulations that are applicable to the particular stage of Development of the Product, including without limitation, GLPs, GCPs and CGMPs. Neither Party makes any warranties or representations whatsoever that any Product NDA approval will be granted regarding Product.

 

4.6                                                  Ownership and Use of Data.

 

4.6.1                                        Each Party shall own all data, results, information, developments and documentation generated by activities that were funded solely by it prior to the Date of Agreement.

 

4.6.2                                        USL shall own all data, results, information, developments and documentation generated by activities undertaken after the Date of Agreement in connection with or pursuant to the Development Plan, or otherwise undertaken or paid for by USL, provided that USL and Orion shall jointly own all data, results, information, developments and documentation generated by activities after the Date of Agreement to the extent Orion joins USL in funding such activities, and Orion’s funding exceeds the [***] amount specified in Section 4.7(a)(1). Manufacturing process development and validation, manufacturing scale-up, stability testing, or quality assurance/quality control development for the Product shall be performed by Orion, at its expense, and data, information and documentation related thereto (which is not to be reimbursed by USL) shall be Orion’s Proprietary Information owned by Orion, and USL shall have the right to use all such Orion Proprietary Information as provided in this Agreement.

 

4.6.3                                        It is understood that the terms of Sections 4.6.1 and 4.6.2 shall apply regardless of whether the activity was conducted directly by a Party or by a Third Party (e.g., a contract research organization) on behalf of such Party. Data, results, information, developments and documentation owned by USL in accordance with this Section 4.6 is referred to as “USL Data” and shall be proprietary and confidential to USL. Orion assigns to USL any right it may have in USL Data, and agrees to execute any documents as USL may reasonably request to document and confirm USL’s ownership of the USL Data.

 

(a)                                 Orion shall make available all data, results, information, development and documentation of Orion that is a part of Orion Proprietary Information for use in connection with USL’s performance of this Agreement regarding the Product in the

 

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Territory. USL agrees to share with Orion all pre-clinical and clinical research data and results involving Product which it has developed, develops, or obtains from a Third Party during the Term, as well as correspondence with the FDA and minutes of meetings with the FDA regarding the Product. Such sharing by each Party shall take place as soon as reasonably practicable after such data or results become available, but in no event shall a final study report (“Final Study Report”) for a clinical study involving Product be provided later than twelve (12) months after data base lock for such study, and provided further that any disclosure of information to be shared is not restricted by any Third Party contractual obligations preventing such disclosure by a Party to the other. Each of USL and Orion agrees that it will use commercially reasonable efforts to avoid subjecting itself to such restrictions that would prevent such disclosures to Orion. Such data and results shall be provided to Orion subject to the confidentiality and use restrictions under which each is bound under this Agreement, (it being understood, however, that, with respect to use of such data permitted under Sections 4.6.4 and 4.6.5, such confidentiality and use restrictions shall be observed to the extent permitted by applicable law, and a party shall not be liable for noncompliance with such restrictions in the use of such data under Sections 4.6.4 and 4.6.5 to the extent compliance with such use and confidentiality restrictions is not permitted by applicable law).

 

(b)                                 Each Party shall be entitled to use in the Territory for the purposes of this Agreement, and Orion shall be entitled to use outside the Territory, as it sees appropriate, free-of-charge and without any limitation in time, any and all data and results of any study or other activity, including without limitation the materials identified in Section 4.6.3 (a) above developed or obtained by USL, and any study reports and abstracts, related to Product conducted by or on behalf of either Party in accordance with the provisions of this Section 4.

 

4.6.4                                        Each Party shall be entitled to, and shall be provided with access to, all Safety Data of the other Party. “Safety Data” means pre-clinical and clinical data relating to the Product useful for or in connection with demonstrating the safety of the Product for use in humans. Each Party may use Safety Data of the other Party in connection with any regulatory filing, whether or not such filing is mandatory.

 

4.6.5                                        If Orion desires to use, or to permit a Third Party licensee to use, USL Data in seeking regulatory approval for the Product in a country outside the Territory where Orion does not yet have such regulatory approval, and the USL Data are pivotal to that application for regulatory approval, Orion shall give USL written notice and the parties shall negotiate in good faith for payment to USL of fair value for such use, considering, among other factors, the expense USL incurred or paid in developing such USL Data. If the Parties reach agreement, Orion shall have the right to use such USL Data, on a confidential basis, for such limited purpose.

 

4.6.6                                        Orion’s obligation to maintain any particular USL Data as confidential or to limit its use of such USL Data shall terminate at when USL, or its designees, publish such particular USL Data without restriction of confidentiality.

 

4.7                                                  Development Costs for Product. Unless the Parties otherwise agree in writing as a part of an amendment to the Development Plan, USL shall be solely responsible for all budgeted Development Costs that are related to the Development of the Product for or in the Territory as set forth in the then current Development Plan, provided, however, that Orion shall be solely responsible for the costs arising from the CMC development for Product within the scope of the

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Initial Development Plan up to the maximum limit of [***]. Save as for the costs arising from said CMC development up to said [***] limit, Orion shall have no responsibility for Development Costs unless Orion agrees in advance in writing. USL shall have no responsibility for any Development Costs to the extent they exceed the budgeted amount for such activities in the then current Development Plan, unless specifically authorized in writing by USL in advance.

 

4.8                                                  Clinical Materials. Orion shall be responsible for providing on a timely basis and against reimbursement of its Clinical Supply Costs all necessary quantities of Product and placebo for use in pre-clinical and clinical trials (including without limitation phase IV (“Phase IV”) and other post-marketing clinical studies) to be conducted by either Party pursuant to this Section 4.

 

4.9                                                  Use of Subcontractors. In the event a Party performs one or more of its obligations regarding the Development of Product through the use of a subcontractor, then such Party shall at all times be responsible for the performance of such subcontractor.

 

4.10                                           Certain Regulatory Costs. The costs incurred by USL in compiling and preparing Product NDAs and any and all other regulatory documents for the Product in the Territory shall be considered part of USL’s Development Costs.

 

4.11                                           Publications. Either Party may publish or present the results of the Development or Phase IV studies carried out on Product by it in accordance with this Agreement, subject to the prior review by the other Party for patentability and protection of such other Party’s Confidential Information. Each Party shall provide to the other Party the opportunity to review any proposed abstracts, manuscripts or summaries of presentations which cover the results of the Development of such Product, or Phase IV studies involving the Product. Each Party shall designate a person who shall be responsible for approving such publications. Such designated person shall respond in writing promptly and in no event later than sixty (60) days after receipt of the proposed material with either approval of the proposed material or a specific statement of concern, based upon either the need to seek patent protection or concern regarding competitive disadvantage arising from the proposal. In the event of concern, the submitting Party agrees not to submit such publication or to make such presentation that contains such information until the other Party is given a reasonable period of time (not to exceed ninety (90) days) to seek patent protection for any material in such publication or presentation which it believes is patentable or to resolve any other issues. With respect to any proposed abstracts, manuscripts or summaries of presentations by investigators or other Third Parties, such materials shall be subject to review under this Section 4.11 only to the extent that USL or Orion (as the case may be) has the right with respect to such Third Party materials to do so. The Parties may agree to accelerate the time periods set forth in this Section 4.11 under special circumstances (e.g. launch of the Product).

 

4.12                                           No Guarantee of Successful Development. For the avoidance of doubt, it is hereby expressly acknowledged and agreed that neither Party gives any representation or warranty, express or implied, nor shall any such warranty or representation be deemed given by either Party, that the Development of product contemplated under this Agreement will be successful or that Regulatory Approval for Product will be granted by the competent Regulatory Authority/ies.

 

5                                                            UP-FRONT AND MILESTONE PAYMENTS

 

5.1                                                  Consideration. As consideration and reimbursement to Orion for certain of its costs and expenses associated with previously completed research, development, and testing for the Product, USL will pay to Orion the payments set forth in Sections 5.2 through 5.5 below, in

 

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U.S. Dollars, all in accordance with the payment schedule, terms and conditions set out herein below.

 

5.2                                                  Up-Front Signing Fee. USL shall pay Orion US Dollars [***] (the “Up-Front Signing Fee”) within ten (10) days following the later of (a) the Date of Agreement and (b) USL’s receipt of Orion’s invoice for such Up-Front Signing Fee.

 

5.3                                                  First Milestone Payment for the Territory. USL shall pay to Orion a first milestone payment of US Dollars [***] (the “First Milestone Payment”) for previously completed research, formulation and clinical development, payable within thirty (30) days after the later of (a) USL’s receipt of notification of FDA Acceptance of the Product NDA, accompanied by a copy of such FDA Acceptance, if any, and (b) USL’s receipt of Orion’s invoice for such First Milestone Payment.

 

For purposes of this Section 5.3. “Acceptance” means the earlier of (i) receipt by a Party of written notice of acceptance from the FDA of the Product NDA for the Product, or (ii) sixty (60) days following the filing of such Product NDA with the FDA without the receipt by a Party during such sixty (60) day period of a “Notice of Refusal to File” from the FDA, as the case may be, with respect to such Product NDA.

 

5.4                                                  Second Milestone Payment for the Territory. USL shall pay to Orion a second milestone payment of US Dollars [***] (the “Second Milestone Payment”) for previously completed research, formulation and clinical development, payable within thirty (30) days after the later of (a) USL’s receipt of written notification of approval of the first Product NDA for the Product in the United States including final labelling accompanied by a copy of such FDA approval notice, and (b) USL’s receipt of Orion’s invoice for such Second Milestone Payment.

 

5.5                                                  Third Milestone Payment for the Territory. USL shall pay to Orion a third milestone payment of US Dollars [***] (the “Third Milestone Payment”) for previously completed research, formulation and clinical development, payable within sixty (60) days after the end of the Year, in which Net Sales for any given Year have first equaled or exceeded US Dollars [***], but in no event sooner than sixty days after the end of the second Year.

 

5.6                                                  If USL grants a sublicense of its rights hereunder for the Product in Canada and receives license signing fees or milestone payments (the “Sub licensee Fees”), USL will pay to Orion [***] of the Sublicensee Fees received by USL.

 

5.7                                                  Nature of Milestone Payments. For clarity, each of the milestone payments set forth in Sections 5.2 through 5.5 is a payment for previously completed research, formulation and clinical development shall be payable only with respect only for the first time the Product achieves the specified milestone event. All milestone payments referenced in Sections 5.2 through 5.6 shall be non-refundable, once paid.

 

5.8                                                  Taxes. Any income or other taxes which USL is required by law to pay or withhold on behalf of Orion with respect to any payments payable to Orion under this Agreement shall be deducted from the amount of such payments due, and paid or withheld, as appropriate, by USL on behalf of Orion provided, however, that, to the extent permitted by law, Orion shall be allowed reasonable opportunity to contest any such deduction with the competent authorities. Any such tax required by law to be paid or withheld shall be an expense of, and borne solely by, Orion. USL shall furnish Orion with reasonable evidence of such payment or amount withheld, in electronic or written form, as soon as practicable after such payment is made or such amount is

 

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withheld. The Parties will reasonably cooperate in completing and filing documents required under the provisions of any applicable tax laws or under any other applicable law in connection with the making of any required tax payment or withholding payment, or in connection with any claim to a refund of or credit for any such payment.

 

5.9                                                  Additional Tax Matters. Each Party shall be entitled to all tax benefits, including in particular, tax credits and/or tax deductions attributable to amounts that such Party has funded regarding the Development of Product hereunder. Each Party shall file its federal, state, and local tax returns on a basis consistent with this Agreement, and shall not take any action inconsistent with the other Party’s entitlement to such tax benefits. In the event that a Party, in its reasonable judgment, determines that it must obtain information and verification regarding the use or application of such expenditures in order to prepare its tax returns or to respond to any inquiry during a tax audit or any other inquiry relating to such treatment of its tax return, or to defend its tax position in any proceeding including litigation, the other Party shall reasonably cooperate with the requesting Party and furnish it with such information as it may reasonably require at the requesting Party’s request and expense.

 

6                                                            TERMS AND CONDITIONS — PRODUCT SUPPLY, PAYMENTS AND ROYALTIES

 

6.1                                                  Generally. Subject to the terms and conditions of this Agreement, USL and its Affiliates and Agents shall purchase from Orion all of their requirements in the Territory dining the Term for Product and any other Product Developed pursuant to this Agreement, unless otherwise agreed by the Parties in writing. Orion agrees to supply to USL and its Affiliates and Agents with such quantities of Product as are ordered in accordance with the terms and conditions of this Agreement.

 

(a)                                 Notwithstanding the provisions of Section 6.1, Orion shall not manufacture any Product which utilizes any Patent Rights or other proprietary technology owned by USL (unless Orion has a license to such Patent Rights or other proprietary technology), unless USL has granted Orion rights under such Patent Rights or other proprietary technology to manufacture and sell Product to USL in accordance with this Agreement. USL represents and warrants that it does not, as of the Date of Agreement, hold or control any Patent Rights for which Orion would be required to acquire a license for purposes of manufacturing Product or otherwise exercising Orion’s rights or performing Orion’s obligations under this Agreement. In the event that USL hereafter obtains any such Patent Rights or other proprietary technology, USL shall, and hereby does, grant to Orion the rights under such Patent Rights or other proprietary technology for the limited purpose of manufacturing Product for, and selling Product to, USL in accordance with this Agreement.

 

6.2                                                  Forecasting.

 

(a)                                 Initial Forecast. To better enable Orion to plan its Product production program for the Territory, USL shall inform Orion at least nine (9) months prior to the anticipated date of Orion’s first delivery to USL preceding the anticipated date of the First Commercial Sale of Product in the Territory of USL’s estimated requirements in Units of the Product for the first twenty four (24) calendar months after said First Commercial Sale, (such forecast being referred to herein as an “Initial Forecast”). Until a Routine Forecast is established according to Section 6.2 (b) below, USL will revise this Initial Forecast by the end of each succeeding calendar quarter and inform Orion of same in writing. It is

 

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understood that any estimates provided pursuant to this Section 6.2(a) are provided for planning purposes only and are not intended to be binding upon USL or Orion.

 

(b)                                 Routine Forecast. Prior to the first month of each calendar year, USL will deliver to Orion its nonbinding forecast (the “Routine Forecast”) for the Product on a monthly basis for that calendar year. This Routine Forecast will be updated quarterly on a rolling 12-month basis. Orion will use the Routine Forecast for planning purposes only.

 

(c)                                  Long-term Forecast. Acknowledging Orion’s reasonable need for also long term forecasts to be given by USL in order to be able to plan for and, as necessary, to invest in, additional production capacity, the Parties hereby agree that USL shall furnish Orion annually by November 1 with USL’s best good faith estimates of USL’s Product requirements for the following two (2) years (“Rolling Two Year Forecast”), consistent with its then existing long range planning cycles. It is understood that such estimates are provided for planning purposes only and shall not be binding on USL.

 

6.3                                                  Purchase Orders; Delivery; Delays.

 

(a)                                 USL will provide to Orion a written purchase order for each delivery, not later than ninety (90) days before the required delivery date. Product will be supplied by Orion only against receipt of USL’s written purchase orders (“Purchase Orders”), and only in full batches of a particular dosage form, initially envisaged to be [***] of bulk gel. The foregoing batch sizes shall not be increased without USL’s consent, such consent not to be unreasonably withheld or delayed. Unless otherwise agreed in connection with an order, Orion will fill and ship all orders of Product in accordance with the Purchase Orders. If any USL Purchase Order is not submitted at least ninety (90) days prior to the requested delivery dates, Orion will still use commercially reasonable efforts to meet USL’s requested delivery dates, and if Orion is unable to do so, the Parties agree to extend the delivery date in good faith to a date that does not interfere with other commitments of Orion on not more than a day-for-day basis. Orion may not produce (or have produced) Product more than sixty (60) days prior to the requested shipment date, provided that (1) with respect to Product produced for purchase orders in anticipation of commercial launch of the Product, the Product shall not be produced more than a number of days before shipment as shall be agreed upon by the parties in good faith, and (2) if [***] expiration dating for the Product is approved by the Regulatory Authorities, the sixty (60) day period may be increased to a period equal to a number of days not exceeding [***] of the Product’s expiration dating.

 

(b)                                 Orion’s supply undertakings are contingent upon USL’s compliance with the order and forecasts procedures specified in Sections 6.2 and 6.3(a) and subject to ordered amounts of Product having been forecasted.

 

(c)                                  Orion shall use all reasonable efforts to avoid or minimize delays in supply, including, at USL’s request, the expenditure of premium time, use of additional labor and shipping via expedited routing. Any additional cost caused by such requirements shall be borne by Orion except to the extent the delay was caused by the contributory fault or negligence of USL, the breach of this Agreement by USL or the relevant amounts of Product not having been forecasted. In addition to any other remedies USL may have under this Agreement due to failure or delay by Orion in the delivery of Product, USL shall have the right to cancel any order which is not made available for delivery to USL for more than thirty (30) days after its agreed delivery date so long as such delay has

 

18

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

not been caused due to the contributory fault or negligence of USL or breach of this Agreement by USL, and provided the Product has been forecasted and ordered in accordance with this Section 8.

 

(d)                                 Orion will reserve its production capacity for Product in quantities not more than twenty five percent (25%) in excess of USL’s most recent Routine Forecasts for a Year given pursuant to Section 6.2(b) and Orion’s supply obligations under this Section 6.3(d). Against purchase orders timely made, Orion agrees to supply USL’s requirements of Product for each month provided the order does not exceed USL’s most recent Routine Forecast, as described in Section 6.2(b) above, by more than twenty five percent (25%). Subject to its production capacity and other production scheduling needs and commitments, and the provisions of Section 6.3(e), Orion will use commercially reasonable efforts to supply ordered quantities more than twenty five percent (25%) in excess of amounts forecasted in USL’s most recent Routine Forecast, it being understood that the failure to supply ordered amounts to the extent exceeding USL’s most recent Routine Forecast by more than twenty five percent (25%) will not subject Orion to any penalties or sanctions.

 

(e)                                  Subject to the provisions of Section 6 of this Agreement, and the Quality Assurance Agreement, Orion may satisfy its Product supply obligations to USL under this Agreement either directly or through an Orion Affiliate located either in the Territory or elsewhere, at Orion’s discretion that is approved to manufacture the Product in accordance with the Product NDA; provided, however, that Orion shall at all times remain liable for the performance of any of its Affiliates.

 

6.4                                                  Location of Manufacturing. Product supplied to USL under this Agreement shall be manufactured only in a manufacturing facility that has been designated as an approved manufacturing facility in the applicable Product NDA.

 

6.5                                                  Back-Up Sources of Supply. Should Orion desire to utilize a different supplier for Product other than Orion or should Orion desire to change manufacturing site for Product to a site other than used to manufacture Product as of the Date of Agreement, Orion shall notify USL in writing and the Parties shall thereafter meet to discuss the potential consequences of such a change. In the course of that discussion, if Orion intends to use a different supplier other than an Orion Affiliate, USL may elect itself to manufacture Product, in which case, USL shall be, and hereby is, granted (subject to USL’s royalty payment obligations stipulated for under Section 6.9 or 13.4 (as applicable)) a royalty free right and license to manufacture Product on the same terms as described in Section 6.5(d) and Section 6.6. Orion shall not change manufacturing sites for Product without obtaining USL’s prior written consent, such consent not to be unreasonably withheld. In no event shall USL be obligated to pay a greater Supply Price for Product manufactured at an alternate manufacturing site than the Supply Price paid for Product produced by Orion. In the event USL provides its consent that Orion shall change suppliers or manufacturing facilities for Product, USL shall, upon Orion’s request provide reasonable assistance, at Orion’s cost, to obtain whatever regulatory approvals are required in the Territory, endeavor to have the new site and supplier of the Product approved by the FDA under any current, pending and future Product NDAs. Orion shall at all times remain liable for the supply of Product to USL (as well as all other obligations of Orion under this Agreement) regardless of whether Product is manufactured by Orion, an Orion Affiliate, or a Third Party. To provide for back-up supply capabilities, Orion will take reasonable steps to ensure an ongoing source of supply of Product to meet USL’s requirements, including without limitation reservation of

 

19

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

buffer stock of Compound as provided for herein below, and/or qualification of alternate source or site manufacturing capability for Product, bulk gel sachets, or any combination of the above.

 

(a)                                 In addition to any other remedies USL, may have under this Agreement due to for failure or delay by Orion in the delivery of Product, if Orion is unable, or if it appears reasonably likely that Orion will be unable, either directly, or through an alternative supply source or Orion’s Product reserves, to supply on a timely basis USL’s forecasted requirements for Product pursuant to Section 6.2(a) in accordance with the terms of this Agreement and such inability would continue for a period of greater than sixty (60) days, then USL shall thereafter have the continuing right to manufacture or have manufactured such Product under the terms of this Section 6.5. USL shall have the right to continue to manufacture some or all of its requirements for Product pursuant to this Section 6.5 even after Orion can reasonably demonstrate that it is able to itself resume normal Product manufacture and supply activities and meet USL’s requirements for Product on an ongoing basis.

 

(b)                                 USL shall have the right at any time to qualify, at its expense, its own manufacturing facility as a back-up site for the manufacture of Product at any time during the Term. Orion will provide USL, and shall provide USL, with the manufacturing, process and quality control procedures, documentation and other relevant know-how and information (hereinafter the “Product Manufacturing Know-How”) to the extent reasonably necessary to enable USL to exercise its back-up manufacturing rights pursuant to this Section 6.5. Orion shall assist USL in obtaining all necessary Regulatory Authority approvals for manufacture of Product, and as necessary, active ingredient for the manufacture of Product. In the event that USL exercises its back-up manufacturing rights pursuant to this Section 6.5 or Section 6.18, it shall be free to purchase, at its sole risk and responsibility, Compound from a Third Party. Following the Date of Agreement, Orion shall use commercially reasonable efforts to have USL qualified as an acceptable licensed manufacturer for Product under Orion’s standby manufacturing rights. Orion shall exercise its commercially reasonable efforts to ensure that USL shall have the right to cross reference the DME for Compound cross-referenced by Orion for Product for purposes of qualifying USL’s facility as an approved manufacturing source for Product and to otherwise enable USL to exercise its back-up manufacturing rights under this Agreement.

 

(c)                                  In the event that USL manufactures any Product pursuant to its exercise of its back-up manufacturing rights pursuant to this Section 6.5, then i7SL shall pay any royalty due under Section 6.9 or 13.4 (as applicable) on Net Sales of such Product by USL.

 

6.6                                                  Back-Up Manufacturing License. For the purposes of enabling USL to exercise its back-up manufacturing rights Orion hereby grants USL a worldwide, royalty free license under all Orion Proprietary Information and Orion Patent Rights (if any) for the purpose of enabling USL to manufacture Product solely for sale in the Field in the Territory; provided, however, that USL shall be entitled to exercise said rights solely in accordance with the provisions of Sections 6.5 and 6.18, Orion shall sign such additional documents and do such additional things as may be reasonably necessary to enable USL to exercise its back-up manufacturing rights under this Agreement.

 

6.7                                                  Payment Terms. USL shall pay for Product within thirty (30) days after the later of (a) the date of receipt of Orion’s invoice (which shall contain the relevant purchase order number, and be in agreement with the purchase order referenced), and (b) the date of USL’s receipt of the Product

 

20

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

(accompanied by all necessary documentation). Product shall be invoiced in euros and paid in United States dollars based on a conversion of the invoiced price in euros to United States dollars using the applicable foreign exchange rate listed in the Wall Street Journal on the date in the United States that USL initiates payment (as described with the paragraph immediately below) of that invoice.

 

All payments to be made under this Agreement, including without limitation those under Section 5, shall, unless otherwise agreed, be by bank transfer, e.g. “SWIFT” or comparable bank transfer method to Orion’s designated account in Finland or USL’s designated account in Minneapolis, Minnesota, U.S.A, and be deemed paid when received. The paying Party shall bear all costs in connection with effecting payments. All Product supplied under this Agreement shall be delivered Ex Works, Turku, Finland, per International Chamber of Commerce “Incoterms 2000” incorporated hereto by reference. Upon request of USL, Orion shall arrange for transportation for Product; provided however, that USL shall reimburse Orion for its actual out-of-pocket costs incurred in shipping Product delivered to USL. Title to Product shall transfer to USL upon delivery.

 

Subject to the thirty (30) day cure period applicable to USL as provided in Section 20.2 herein, payment to Orion is a material term in this Agreement.

 

6.8                                                  Supply Price for Territory. Subject to the provisions of Section 6.12, Orion’s supply price to USL for Product (packaged with the applicable number of sachets and plastic box in the final approved printed carton with the package insert) to be sold commercially in the Territory shall be as follows (“Supply Price”);

 

	
Dosage
   Strength
    	
 
    	
Number of
   Sachets per Unit
    	
 
    	
Per Unit Supply
   Price in Euros
    
	
0.25mg
    	
 
    	
30’s
    90’s
    	
 
    	
[***]
    [***]
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
0.5g
    	
 
    	
30’s
    90’s
    	
 
    	
[***]
    [***]
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
1.0g
    	
 
    	
30’s
    90’s
    	
 
    	
[***]
    [***]
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
1.5g
    	
 
    	
30’s
    90’s
    	
 
    	
[***]
    [***]
    

 

6.9                                                  Know-how Royalty. Commencing on the first commercial sale of a given strength of the Product following NDA Approval for that strength and continuing until the end of the Term, USL shall pay Orion a know-how royalty (herein after referred to a the “Know-how Royalty”) equal to “Applicable Percentage” of USL’s Net Sales for Product during the applicable time period. “Applicable Percentage” shall mean [***] for Net Sales during the first twelve (12) months following the First Commercial Sale, whereafter the Applicable Percentage shall be [***].

 

6.10                                           Payment Process. Know-how Royalties will be paid quarterly within sixty (60) days after the end of each USL quarter for which any Know-how Royalties may be due. At the same time, USL shall submit a report of quarterly Net Sales in the Territory listing the Net Sales of USL during that USL quarter on which Know-how Royalties are due in accordance with Section 6.9.

 

21

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

6.10.1                                 Orion’s Audit Rights. USL shall maintain, and require its Affiliates (and Agents, if applicable) to maintain, accurate records of all Net Sales and Sample distribution in the Territory as well as relevant invoicing or other documentation relating thereto. Upon reasonable prior written notice from Orion, USL shall allow such records to be made open to audit on Orion’s behalf by an independent certified public accountant of Orion’s selection, except one who is currently engaged by USL or one to whom USL may have a reasonable objection, to verify that the Know-how Royalties have been accurately computed on Net Sales. Such accountant shall be first made subject to confidentiality obligations not less strict than those to which Orion and USL are subject to under this Agreement. The accountants shall be allowed to report to Orion only whether the Net Sales are accurate and correct and made in accordance with this Agreement, and if not, what the correct calculations should have been and the basis for same in said accountant’s professional opinion. For these purposes Orion’s accountant may examine and make abstracts of the records to be kept pursuant to this Agreement. Such audit shall occur during normal business hours and no more often than once per Year. The audit may be requested for up to two (2) of the most recent Years prior to the Year of the request. Accordingly, the USL records which are the object of this audit clause shall be maintained and be made available for audit for a period of at least two (2) years from the end of each then current Year. USL shall be provided a copy of any report or other documentation prepared by Orion’s accountant regarding the results of its audit. Once an audit has been conducted for a particular Year, the reports provided by USL for such Year regarding Net Sales and Sample distribution calculations, as adjusted by the results of any audit, shall be deemed to be conclusive and binding upon the Parties. Furthermore, following the expiration of any period in which Orion may audit USL’s records for a particular Year in accordance with the provisions of this Section 6.10.1, the reports provided by USL for such Year regarding Net Sales and Sample distribution shall be deemed to be conclusive and binding upon the Parties.

 

Once an audit has been conducted for a particular period, the calculation of Know-how Royalties for such period, as adjusted by the results of any audit, shall be deemed to be conclusive and binding upon the Parties. Furthermore, following the expiration of any period in which Orion may audit USL’s records for a particular period in accordance with the provisions of this Section 6.10.1, the Know-how Royalties due by USL for such period as stated in USL’s quarterly reports shall be deemed to be conclusive and binding upon the Parties.

 

6.10.2                                 Correction of Underpayment or Overpayment. In the event that Orion’s accountant finds any errors that have resulted in an underpayment of Know-how Royalties to Orion, then upon Orion’s request, and subject to the provisions of Section 6.10.4, USL shall promptly refund or credit to Orion’s account any amount owed to Orion in accordance with the findings of such accountant. In the event that such independent certified public accountant finds any error to the detriment of USL, Orion shall promptly refund or credit to USL any amount owed to USL in accordance with the findings of such accountant.

 

6.10.3                                 Responsibility for Costs of Audit. The accountant’s fees and expenses associated with any such audit shall be borne by Orion, provided that USL shall reimburse Orion for same in the event the audit reveals an underpayment of Know-how Royalties by USL to Orion for a given Year of more than [***] as a result of USL’s errors in Net Sales or Sample distribution calculations.

 

6.10.4                                 Disputes Regarding Audit Findings. In the event that USL in good faith disputes any conclusion of the accounting firm under Section 6.10.1, including that USL owes additional amounts, then USL shall inform Orion by written notice within thirty (30) days of receipt of a copy of the audit in question, specifying in detail such dispute. The Parties shall promptly thereafter meet and negotiate in good faith a resolution to such dispute. In the event that the Parties are unable to

 

22

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

resolve such dispute within sixty (60) days after notice by USL, the matter shall be resolved in a manner consistent with the procedures set forth in Section 26.

 

6.10.5                                 Single Royalty Payment. The obligation to pay Know-how Royalties to Orion under Section 6.9 (or any royalty due under Section 13.4) is imposed only once with respect to the same unit of the Product, regardless of the number of Orion Patent Rights or the non-patented Orion Proprietary Information covering the same. There shall be no obligation to pay Orion an Know-how Royalty on the sale of the Product between USL and its Affiliates, or a sublicensee (other than a private label distributor of USL, it being understood that USL shall pay Know-how royalties on its Net Sales to a private label distributor of USL, and no royalty shall be due hereunder on the subsequent sale by the Third Party private label distributor).

 

6.10.6                                 Know-how Royalties on Sublicenses. If USL grants a sublicense (which for purposes of this Section 6.10.6 does not include a Third Party private label distributor of USL), any such sublicense shall contain appropriate provisions to obligate the sublicensee to pay Orion the same Know-how Royalty on Net Sales that USL would have to pay on its own Net Sales of the Product, and any such Know-How Royalties in the amount specified in Section 6.9 owed on Net Sales by a sublicense shall be collected by USL and paid to Orion.

 

6.11                                           Currency Conversion. All royalties will be paid in U.S. dollars. Royalties due on Net Sales in the currency of countries foreign to the United States will be calculated and paid in U.S. dollars after the amount of the Net Sales in foreign currency have been converted into U.S. dollars using the applicable foreign exchange rate listed in the Wall Street Journal for the last day of the calendar quarter in which the particular revenues included in the Net Sales were accrued or if there is an applicable forward exchange contract, at the forward exchange rate.

 

For example, if revenues included in Net Sales are earned in Canadian dollars in December of a given year and there is not forward exchange contract in effect, then the Net Sales in Canadian dollars will be converted into U.S. dollars based on the exchange rate between the Canadian dollars and U.S. dollars as listed in the Wall Street Journal for the last day of that December. If a foreign exchange contract is in effect for such period, then the Net Sales in Canadian dollars will be converted into U.S. dollars at forward exchange rate in such contract.

 

6.12                                           Supply Price Adjustment. Orion shall have the right to adjust the Supply Price to USL for Product once per Year, pursuant to the provisions of Section 6.12 (c), provided that (a) Orion gives written notice to USL, at least ninety (90) days prior to the beginning of the Year in which said adjustment shall take effect, of the amount of the adjustment, and (b) in no event shall the Supply Price stated in this Agreement change before the end of the first Year. In the event that an adjustment of the Supply Price calculated in accordance with this Section 6.12 would result in a reduction of the Supply Price, Orion shall also adjust the Supply Price accordingly.

 

(a)                                 Any adjustment of the Supply Price after the Date of Agreement shall be based only on bona fide increases or decreases in Orion’s FAMC as of the Date of Agreement, and thereafter from the date of the last notice of price change, all as recorded and consistently applied by Orion’s internal accounting system and in compliance with Finnish generally accepted accounting principles. Any notice of a change in the Supplied Price given by Orion to USL in accordance with Section 6.12 shall be accompanied by supporting documentation evidencing increases or decreases in Orion’s FAMC. However, any increase shall not exceed (as a percentage) at any one time [***] of the Producer Price Index for Manufactured Product in Finland (published by the government’s “Center for Statistics” = Statistics Finland; “Tilastokeskus”).

 

23

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

(b)                                 Orion agrees to maintain complete and accurate records in accordance with “Finnish GAAP” for the purposes of evidencing Orion’s FAMC. Upon reasonable prior written notice from USL, Orion will make such records available during normal business hours, but not more frequently than once per Year, to enable an independent certified public accountant of USL’s selection, except one who is currently engaged by Orion or one to whom Orion may have a reasonable objection, to verify that the Supply Price does not exceed the FAMC and that the adjustments to Supply Price have been accurately made and are in accordance with this Agreement. Such accountant shall first be bound by confidentiality obligations no less strict than those to which Orion and USL are bound under this Agreement. The accountant shall be allowed to report to USL only whether Orion’s Supply Price does not exceed the FAMC and that adjustments and calculations of increases or decreases in the Supply Price are correct or incorrect and, if incorrect, what the correct amount should have been and, on what basis, in the accountant’s professional opinion. For these purposes Orion’s accountant may examine and make abstracts of the records to be kept pursuant to this Agreement.

 

The accountant’s fees and expenses associated with any such verification shall be borne by USL, provided that Orion shall reimburse USL for same in the event the audit reveals that an increase in the Supply Price requested by Orion represented an overpayment by USL of more than [***] of the amount that such increase should have been as a result of Orion’s error in calculations involving the Supply Price. Orion shall promptly refund or credit to USL any amount owed to USL in accordance with the findings of such independent certified public accountant, unless such findings are disputed.

 

In the event that Orion in good faith disputes any conclusion of the accounting firm under this Section 6.12(b), then Orion shall inform USL by written notice within thirty (30) days of receipt of a copy of the audit in question, specifying in detail such dispute. The Parties shall promptly thereafter meet and negotiate in good faith a resolution to such dispute. In the event that the Parties are unable to resolve such dispute within sixty (60) days after notice by Orion, the matter shall be resolved in a manner consistent with the procedures set forth in Section 25.

 

The audit may be requested for up to two (2) of the most recent Years prior to the Year of the request. Accordingly, the Orion records which are the object of this audit clause shall be maintained and be made available for audit for the period covering at least the two (2) prior Years from the end of each then current Year.

 

Once an audit has been conducted for a particular Year, the Supply Price for such Year, as adjusted by the results of any audit, shall be deemed to be conclusive and binding upon the Parties. Furthermore, following the expiration of any period in which USL may audit USL’s records for a particular Year in accordance with the provisions of this Section 6.12(b), the Supply Price charged by Orion for such Year shall be deemed to be conclusive and binding upon the Parties.

 

(c)                                  The principles for determining a Party’s FAMC are set forth in Schedule 4.

 

6.13                                           Responsibility for Customs Duties and Taxes on Re-sale of Product. USL shall bear and pay all taxes, duties, levies and other charges imposed on it by reason of its purchase, import or resale of Product (excluding any taxes which are due or based upon Orion’s income). For clarity, Orion shall be solely responsible for and shall bear all taxes, duties, levies and other charges imposed by reason of its manufacture of Product and sale of same to USL. Orion will package and ship

 

24

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Product to USL in accordance with obligations placed on the seller under the applicable “Incoterms” provisions relating to a delivery. Orion will also comply with such other reasonable shipping or packaging requirements of USL, including special shipping configurations or bar coding, as Orion and USL shall beforehand expressly agree in writing regarding a particular order or shipment of Product.

 

6.14                                           Interest Upon Overdue Amounts. Each Party reserves the right to charge and the other Party hereby agrees to pay interest on any overdue amounts owed to a Party in connection with this Agreement which still remain unpaid after notice of delinquency and time for cure has expired in accordance with Section 22.2 herein below, at a rate of [***] per annum.

 

6.15                                           USL’s Right to Establish Re-sale Price. USL and its Affiliate(s) and Agent(s), as applicable, dealing with Product in the Territory shall establish their own terms of resale, including resale price, for Product.

 

6.16                                           Right to Withhold Supply of Product. Without limiting Orion’s rights pursuant to Section 20.2 or any other rights or remedies Orion may have under this Agreement, Orion reserves the right to withhold delivery of Product, whether based on an accepted order or not, in the event USL fails to cure any breach of its payment obligations hereunder within thirty (30) days after written notice and demand for cure of such breach.

 

6.17                                           Conflict in Forms. All sales of Product by Orion to USL will be subject to the provisions of this Agreement and will not be subject to the terms and conditions contained in any purchase order of USL or confirmation of Orion, except insofar as any such purchase order or confirmation establishes (a) the quantity of Product to be sold, (b) the shipment dates for the Product, and (c) the destinations to which those Product are to be shipped.

 

6.18                                           Potential Extension of Supply Arrangements. To the extent that USL has the continued right to sell Product in the Territory after the expiration of the Term in accordance with Section 20.9 of this Agreement, Orion shall continue to supply USL its requirements for Product in accordance with the terms of this Agreement, provided that Orion may give USL written notice that it desires not to continue to supply and sell Product to USL, in which event USL shall have, and Orion hereby grants to USL, the right and license (and agrees to furnish USL, at USL’s expense, the reasonable assistance) to manufacture or have manufactured Product in accordance with the terms of Sections 6.5 and 6.6 above. Orion shall, in all events continue to supply Product to USL in accordance with the terms of this Agreement through the later of the expiration date of the Term of this Agreement, or [***] months after Orion’s notice to USL that it does not desire to continue to supply and sell Product to USL under this Agreement. If USL, despite its good faith efforts and not due to any negligence or misconduct on the part of USL, is unable to obtain USL approval to manufacture or have product manufactured at another facility and to commence production of commercial quantities of the Product before the end of such [***] month period, then Orion shall continue to supply USL for a period of [***] months after the date of Orion’s notice.

 

6.19                                           Responsibility for Manufacturing-Related Expenses. The Party who is responsible for manufacturing Product under this Section 6 shall be responsible for any costs and expenses incurred in connection with manufacturing process development and validation, formulation development, manufacturing scale-up, stability testing, and quality assurance/quality control development.

 

25

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

7                                                            USL’S DILIGENCE OBLIGATIONS REGARDING COMMERCIALIZATION

 

7.1                                                  Diligence Obligations. USL shall use commercially reasonable efforts to market and promote Product in the Territory, consistent with the same level of efforts that it would apply to a product of its own that it is of comparable market potential.

 

7.2                                                  Projected Sales Level Statements and Minimum Sales Obligation. No later than November 1 of each Year commencing in the fifth Year, USL shall provide Orion with a good faith forecast of its projected Net Sales of the Product in the Territory for the next Year (“Projected Sales Level Statement”), taking into account, among other things, uncertainties regarding the entrance of competitive products into the marketplace, the commercialization strategies pursued by competitive products and the impact of such products upon the market for the Product, the timing of any Regulatory Approvals for new indications in the Field for the Product, changes in prescribing behaviors for physicians, and acceptance of the Product and competitive products on managed care formularies. Each such Projected Sales Level Statement shall be based upon USL’s own internal budgets applicable for the relevant Year, and shall be approved USL’s Vice President of Sales and. Marketing.

 

USL shall achieve the minimum Net Sales (the “Minimum Net Sales”) of the Product listed below (it being understood that Net Sales of USL Affiliates and sublicensees will be included for purposes of USL satisfying the Minimum Net Sales requirement):

 

	
Year
    	
 
    	
Minimum Net Sales
    
	
First   Year
    	
 
    	
[***]
    
	
2nd Year
    	
 
    	
[***]
    
	
3rd Year
    	
 
    	
[***]
    
	
4th Year
    	
 
    	
[***]
    
	
5th Year
    	
 
    	
[***]
    
	
thereafter
    	
 
    	
[***] of the Projected Sales Level for such Year
    

 

If during the applicable Year supply or sale of the Product is impaired or impracticable due to Force Majeure, action by competent government authorities, or a claim by a Third Party that sale of the Product infringes the intellectual property rights of the Third Party, the Minimum Net Sales for that Year shall be prorated and the Minimum Net Sales thereafter for any of the Years 2 through 5 (as applicable) will be renegotiated by the Parties in good faith. Further, in the event a third party obtains regulatory approval in the Territory for any other product that is AB rated or AT rated to the Product, the obligation for Minimum Net Sales shall thereafter be null and void, and the Minimum Net Sales for that Year in which such event occurs shall be prorated.

 

7.3                                                  Failure to Achieve Minimum Net Sales. In the event that the actual Net Sales of the Product in the Territory for a given Year are less than the applicable Minimum Net Sales for that Year (for reasons other than those described in the last paragraph of Section 7.2 above) (such shortfall referred to as a “Net Sales Shortfall”), then ninety (90) days after the end of the applicable Year, USL shall pay to Orion a “Shortfall Royalty” equal to Applicable Percentage (as defined in Section 6.9) multiplied by the Net Sales Shortfall.

 

7.4                                                  Certain USL Rights. If there has been a Net Sales Shortfall in any Year due to reasons beyond the control of USL, including without limitation, changes in the prescribing practices, regulatory considerations, or acceptance of the product class in the Territory to which Product belongs,

 

26

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

then provided USL has paid the applicable Net Sales Shortfall, USL may give written notice, within ninety (90) days after the end of the applicable Year, of its desire to renegotiate in good faith the Minimum Net Sales for subsequent Years commencing with the Year following the one in which the Net Sales Shortfall occurred that triggered USL’s notice to renegotiate. Upon such notice from USL, Orion shall (within thirty (30) days) give USL written notice indicating either that it is willing to renegotiate the Minimum Net Sales, or that it does not wish to do so. If Orion does not give timely written notice that Orion wishes to renegotiate, USL may at any time after expiration of the thirty-day notice period, give Orion written notice of termination which will be effective ninety (90) days following the date of the notice of termination. If Orion gives timely written notice that it is willing to renegotiate, USL and Orion shall enter into good faith negotiations for a period of ninety (90) days (commencing with the date of Orion’s written notice). If they are unable to reach agreement to adjust the Minimum Net Sales during that time period, then USL may at any time within ninety (90) days after expiration of the ninety-day negotiation period give Orion written notice of termination which will be effective ninety (90) days following the date of the notice of termination. If the parties reach agreement to adjust the Minimum Net Sales, such adjustment shall be effective as of the first day of the Year in which USL gave notice to renegotiate under this Section. If this Agreement terminates pursuant to this Section, USL shall have no Shortfall Royalty obligation for any period after the end of the Year in which the Shortfall occurred that triggered USL’s notice to renegotiate under this Section.

 

7.5                                                  Certain Orion Rights. In the event that a Net Sales Shortfall occurs under Section 7.2 in any two (2) Years of a three (3) Year period commencing after the first two Years (it being understood that a Net Sales Shortfall in either of two first Years shall not be considered for purposes of Orion’s right of termination under this Section 7.5), Orion, at its option, may terminate this Agreement, provided Orion gives notice of termination specifically referencing this Section 7.5 and stating the basis for such termination within thirty (30) days following Orion’s receipt from USL of the report described in Section 6.10 following the end of the second such Year in such three-Year period. Such termination shall be effective ninety (90) days following USL’s receipt of such notice of termination. In the event Orion terminates USL pursuant to this Section 7.5, USL shall have no obligation to pay the accrued Shortfall Royalty for the Year that triggered Orion’s right to terminate under this Section 7.5.

 

7.6                                                  USL Efforts to Launch. USL shall use commercially reasonable efforts to launch the Product in the Territory within three (3) months following receipt of the NDA Approval for the Product in the Territory. In no event shall USL have any liability if USL is unable to launch within such three-month period due to Orion’s failure to supply required ordered amounts of Product sufficient to satisfy Product launch needs.

 

8                                                            REGULATORY MATTERS

 

8.1                                                  Ownership of Regulatory Filings in the Territory. All INDs and NDAs for the Product(s) in the Territory shall be owned by and held in USL’s name as sponsor of record. Following the Date of Agreement, Orion shall license, transfer, provide a letter of reference with respect to, or take such other action necessary to make available all possible liNDs, if any, in the Territory held in Orion’s name at any time during the Term in order to permit USL to exercise its rights under this Agreement.

 

8.2                                                  USL’s Diligence Obligations Regarding Development of Product and Preparation of Product NDA. USL shall be responsible for diligently compiling the Product NDA in accordance with the Development Plan, and for having it filed with the FDA within five (5) months after USL’s receipt of all data, information and documents (including without limitation, all analyses and

 

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re-analyses) necessary or beneficial to prepare such filing, and for obtaining FDA Acceptance of the Product NDA. Such filing shall include all data and documentation reasonably required for such Product NDA filing and be made in accordance with the then prevailing FDA requirements for form and content for such a filing.

 

8.3                                                  Regulatory Submissions for the Territory. USL shall be responsible for diligently compiling and preparing all Product NDAs for the Territory and seeking, obtaining and maintaining Regulatory Approval for the Product in the Territory in accordance with the terms and conditions of this Agreement. USL will be responsible for all costs and expenses associated therewith. If the FDA requires, or USL otherwise determines that it would be beneficial to obtain, additional clinical or pre-clinical data, in connection with obtaining or maintaining Regulatory Approval for the Product in the Territory, USL shall be responsible for the associated costs; provided that, if such costs exceed the budget in the then current Development Plan (“Budget”), USL agrees to undertake such additional studies and does not terminate the Agreement in accordance with Section 4.4.3(b). Orion shall furnish such assistance as USL may reasonably request, or as specified in the Development Plan, and. USL shall reimburse Orion for its costs for so assisting in accordance with the Budget in the then current Development Plan, or as pre-approved by USL to the extent such costs exceed or are not included in the Budget. Without limitation, Orion shall prepare and submit to USL on a timely basis as specified by USL any and all data or other information available to Orion or developed by or on behalf of Orion pursuant to this Agreement related to the manufacture and analytical testing (including without limitation stability testing and all associated protocols and procedures) of the Product, the manufacturing process for the Product, including without limitation any quality control procedures, or any facility used to manufacture the Product to be included in any regulatory filings for Product. Following the Date of Agreement, USL shall oversee, monitor, control and coordinate all regulatory actions, communications and filings with and submissions, including filings and submissions to INDs and Product NDAs for Product, and any supplements and amendments thereto, to the FDA and other Regulatory Authorities in the Territory with respect to all Product. USL shall keep Orion reasonably informed of its efforts and activities in seeking, obtaining and maintaining Regulatory Approval for the Product in the Territory. Orion shall defer to USL’s strategy, recommendations and guidance with respect to matters involving preparation of such Product NDA and dealings with the FDA and other Regulatory Authorities on all such Product NDA and other regulatory related matters relating to Product within ethical and legal limits; provided that Orion shall have the right to comment on the proposed labeling as well as on matters concerning safety and efficacy in the Product NDA, provided further that any such comments are submitted to USL in accordance with such timelines as USL applies internally. Orion will provide all documentation required to compile the chemistry, manufacturing, controls and the pre-clinical pharmacology and toxicology sections of the IND and NDA in accordance with the Development Plan. Orion will be responsible for obtaining for USL all (a) authorizations permitting USL to reference their suppliers’ DMFs for Compound, excipients and packaging supplies (as applicable) as required to support USL’s regulatory filings in the Territory, (b) certifications of CGMP compliance on the part of each Supplier, and (c) certifications on nondebarment under Section 306(a) and (b) of the Generic Drug Enforcement Act of 1992 in form reasonably satisfactory to USL for each supplier. Orion shall promptly furnish to USL copies of all such authorizations and certifications. In addition, Orion will provide, as applicable, USL with all available clinical study reports, electronic data sets and copies of case report forms (and any such reports, data sets and forms as are developed by or on behalf of Orion pursuant to this Agreement) for USL to complete the clinical and safety sections of the IND and NDA in accordance with the Development Plan. All documents, including without limitation, any master batch records (and any subsequent modifications thereof), to be furnished

 

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by Orion under this Agreement for use in filings with the FDA shall be provided by Orion in English, except as the parties may otherwise agree in writing.

 

8.4                                                  Regulatory Liaison. USL shall be responsible for interfacing, corresponding and meeting with the FDA and other Regulatory Authorities in the Territory with respect to the Product. Without limiting the generality of the foregoing, USL will act as the Sponsor upon whom service of all processes, notices, orders, decisions, requirements, and other FDA communications shall be made with regard to all INDs and Product NDAs for the Product in the Territory. Orion shall have the right to participate and cooperate in such meetings (and planning therefor), as may be appropriate and reasonable.

 

8.5                                                  Regulatory Fees. All fees payable during the Term to the Regulatory Authority in the Territory, including without limitation any so called “annual user fee” or Regulatory Approval maintenance fees for the Product, as well as annual prescription drug product fees shall be borne and paid solely by [***]. Further, any fees payable to FDA or other Regulatory Authority in the Territory in connection with the filing or Regulatory Approval of Product shall be borne and paid solely by [***]. Any fees payable to FDA or other Regulatory Authorities related to any facilities used to manufacture the Product shall be the sole responsibility of [***]; provided, however, the foregoing shall not apply with respect to Product in the case where Orion elects not to, or is not entitled to, supply such Product pursuant to the provisions of Section 6.1.

 

8.6                                                  Manufacturer’s Documentation for Regulatory Purposes (“DMF”). Notwithstanding anything contained in this Agreement to the contrary, Orion shall at its expense have secured as of the Date of Agreement and shall maintain for so long as USL has the right to sell Product in the Territory under this Agreement, an authorization permitting USL to cross-refer to the DMF related to Compound used by Orion for manufacture of Product for reference by the Product NDAs. Such DMF shall contain all information related to the manufacture of Compound and the manufacturing facility used to produce Compound that is reasonably necessary to facilitate obtaining Regulatory Approvals for the Product in the Territory. Such authorization shall include the right of reference to such DMFs by all of the INDs and Product NDAs submitted under this Section 8.

 

8.7                                                  Manufacturing Regulatory Matters. Notwithstanding the provisions of Section 8.3, Orion will be responsible for any reporting of matters regarding the manufacturing of Product to USL, and USL will notify the FDA in accordance with pertinent laws and regulations. Orion shall immediately notify USL of any such matter if significant or serious and promptly furnish to USL complete copies of such reports submitted by Orion to the FDA. Orion shall also advise USL of any occurrence or information which arise out of Orion’s manufacturing activities, which have or could reasonably be expected to have adverse regulatory compliance and/or reporting consequences or adverse impact on the Development or commercialization of Product. Orion shall be responsible for handling and responding to any appropriate governmental agency inspections with respect to manufacturing of Product, and shall provide information related thereto to USL in accordance with the provisions of Section 8.10. In addition, Orion must immediately communicate to USL any quality issues or failures of audits of the FDA that affect USL’s ability to obtain, promote or sell Product in the Territory. Orion will furnish USL with copies of all investigation reports directly relating to or impacting the Product. Without limiting the generality of the foregoing, Orion shall supply USL with the following information in a timely manner for USL’s annual regulatory filing: copies of all exception reports; copies of all complaint reports; analytical results for all lots manufactured; an inspection report of all house samples; stability data for all lots for which stability testing is ongoing; reports regarding any formulation changes, manufacturing or packaging process changes and production batch record

 

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alterations (including a complete description and rationale for all such changes); and any data involving recalls or field corrections. No changes shall be made without following the change control process as described in the Quality Assurance Agreement.

 

8.8                                                  Pharmacovigilance. As soon as reasonably possible, the drug safety departments of both Parties shall meet and determine the approach to be taken for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product, which approach shall be documented in a Schedule 5 to this Agreement to be finalized and attached to, and incorporated in, this Agreement not later than one hundred eighty days (180) days after the Date of Agreement. Schedule 5 will, without limitation, cover current pre-marketing situation in the Territory. Prior to approval in any country of the Territory both Parties will meet to discuss and agree on amendments to be made to the Schedule 5. Also without limitation, Schedule 5 shall provide that Orion and USL shall each notify the other Party within fifteen (15) days after any labeling changes related to safety or adverse events associated with the Product submitted by them to, or required of them by, local Regulatory Authorities. Moreover, Schedule 5 shall provide that Orion shall forward to USL within fifteen (15) days after Orion receives, or learns of, any similar labeling changes submitted by other licensees of Orion to local regulatory authorities.

 

USL shall be responsible for collection, review, assessment and tracking of information related to adverse events associated with the Product in the Territory, and filing with applicable Regulatory Authorities in the Territory any reports, individual and/or periodic, regarding any adverse events related to the Product as required by local Regulatory Authorities in the Territory, including without limitation any information regarding such adverse events which is received from Orion or from a Third Party. Orion shall be responsible for collection, review, assessment and tracking of information related to adverse events associated with the Product (a) in countries where Orion itself markets the Product, and (b) elsewhere outside the Territory to the extent Orion receives, or learns of, learns of such information. Orion and USL shall co-operate closely for purposes of having safety data exchanged between the drug safety departments of both companies in as timely fashion as possible.

 

8.9                                                  Quality Assurance Agreement. Orion and USL will agree upon a Quality Assurance Agreement for the Product. Such Agreement shall be finalized and executed on the Date of Agreement and not be inconsistent with Orion’s and USL’s current quality assurance programs or require material investments by Orion to implement, except to the extent such investments are required to enable the Parties to comply with applicable laws.

 

8.10                                           Assistance. In addition to any obligations of the Parties under other subsections of this Section 8, each Party shall promptly inform the other Party of any notification of any action by, or notification or other information which it receives from the FDA or any other Regulatory Authority, which (a) raises any material concerns regarding the safety or efficacy of any Product, or (b) which indicates a reasonable potential for a recall or market withdrawal of any Product, provided that neither Party shall be obliged to disclose information which would violate or cause a waiver of its attorney/client privilege or similar right. Information that shall be disclosed pursuant to this Section 8.10 shall include, but not be limited to:

 

(i)                                     inquiries by governmental or Regulatory Authorities concerning clinical investigation activities (including inquiries of investigators, clinical monitoring organizations and other related parties) relating to Product, and any responses related thereto;

 

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(ii)                                  any material communication from governmental or Regulatory Authorities pertaining to the manufacture, sale, promotion or distribution of Product, and any responses related thereto;

 

(iii)                               receipt of a warning letter relating to any of the Product, and any responses related thereto; and

 

(iv)                              an initiation of any governmental or regulatory authority investigation, detention, seizure or injunction concerning any Product.

 

9                                                            SAMPLES

 

9.1                                                  In order to support USL’s marketing and promotion efforts for Product in the Territory, Orion will supply Samples to USL for use in the Territory all on the terms and conditions set forth in this Section 9.

 

(a)                                 Orion will supply USL with Samples of the Product for distribution in the Territory at a price equal to Orion’s FAMC (the “Sample Price”).

 

(b)                                 The Forecasts that USL provides in accordance with Section 6.2 above shall include USL’s forecast for Samples, and the Purchase Orders that USL provides in accordance with Section 6.3 above shall include USL’s Purchase Orders for Samples. The payment terms for Samples shall be the same as for other units of Product as set forth in Section 6.7.

 

It is agreed that the supply of Samples by Orion to USL shall not exceed the following maximum Sample volumes for each such Year:

 

	
Maximum Volume of Samples of Product
    
	
Year 1
    	
 
    	
Year 2
    	
 
    	
Year 3 and each Year thereafter
    
	
[***] units
    	
 
    	
[***] units
    	
 
    	
[***] units
    

 

10                                                     MARKETING, ADVERTISING AND PROMOTIONAL EFFORTS FOR PRODUCT

 

10.1                                           Marketing and Sales Personnel. USL agrees that during the Term of this Agreement it will maintain, and ensure that its Affiliate(s) and Agents dealing with Product in the Territory maintain (it being understood that USL’s obligation for marketing, advertising and promotion) shall be satisfied with respect to Canada if USL uses reasonable commercial efforts to secure a sublicense with respect to Canada, in which event, the sublicense shall perform marketing, advertising and promotional efforts in Canada as contemplated by this Agreement), active and efficient sales, marketing and customer service organizations with adequately trained personnel for marketing, pre-marketing and selling Product throughout the Territory.

 

10.2                                           Inventory Requirements. Subject to receiving sufficient quantities of Product from Orion pursuant to Section 6, USL will maintain an adequate stock of the Product in the Territory consistent with USL’s projected Net Sales estimates for each Year to meet normal market demand.

 

10.3                                           Potential Marketing and Promotional Activities. Without limiting its undertakings in Section 10.1 above, USL will conduct marketing, advertising and promotional activities throughout the Territory, which may include advertising of Product by mail to health care professionals,

 

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advertisements in major professional periodicals and journals, promotion of Product at major events in the trade within the Territory and personal calls by USL representatives on prescribers of Product in the Territory, consistent with USL’s own products of similar nature, value and status.

 

10.4                                           Responsibility for Content of Promotional Materials and other Marketing Collaboration. USL shall bear all responsibility with regard to the nature, content and use of all advertising, promotional materials, packaging and the like for the Product which it and/or its Affiliates or Agents use in connection with the marketing, promotion and sale of the Product in the Territory. It shall be USL’s responsibility to ensure that all of said materials it uses conform to the legal requirements in the Territory including approved labeling, directions, and inserts for Product under the approved Product NDA or Regulatory Approval as applicable. Upon request, USL shall, without undue delay, provide Orion with current copies of advertising and promotional materials related to Product, which it utilizes in the Territory. It is agreed that Orion’s review of such materials shall not be deemed a qualification of or otherwise release USL of its sole and exclusive responsibility relating to any use of same, nor shall any Orion prior review be a prerequisite for USL’s use of such materials.

 

10.5                                           Inclusion of Orion’s Name on Packaging, Labeling and other Materials. USL agrees that, to the extent consistent with and subject to regulatory requirements in the Territory and subject to availability of sufficient space, appropriate language shall be included on the labeling and packaging for the Product, consistent with regulatory requirements in the Territory, identifying the Product as being manufactured by Orion and marketed or distributed by USL.

 

10.6                                           Supplies for Phase IV Studies. Orion shall (a) provide, on a timely basis, necessary quantities of Product and placebo for use in Phase IV studies required by the FDA, and (b) use reasonable efforts to provide, on a timely basis, reasonable quantities of Product and placebo for use in investigator initiated studies, pharmaco-economic studies, outcomes studies and other studies that are designed to support marketing of Product in the Territory. In the case of Product to be used in such studies, USL shall pay the Sample Price for such materials.

 

10.7                                           Responsibility for Packaging. Orion will furnish to USL copies of Orion’s existing labeling and packaging. USL will revise that labeling and packaging to include USL’s logos, trademarks and other modifications, whether required by the Regulatory Approval or proposed by USL. USL will prepare and submit to Orion specifications and all artwork and copy, in camera ready form, for all packaging and labeling. Orion will furnish USL a reasonable opportunity (but in no event exceeding 10 days) to review and approve all specifications (including art proofs) for Product packaging and labeling before their submission to the printer. Product delivered by Orion shall be complete with appropriate packaging, labeling and assembly as approved by USL. For the avoidance of doubt, it is hereby acknowledged and agreed that USL shall, as the Regulatory Approval owner and holder of record for Product in the Territory, be responsible for the label content and design, and for proof of the labeling for the Product for the Territory.

 

11                                                     COMPETING PRODUCT

 

11.1                                           Potential Termination for Dealing with a Competing Product. Should USL commence Dealing with a Competing Product at any time after the Date of Agreement, Orion shall have the right to terminate this Agreement on thirty (30) days written notice, provided that, if an event described in Section 11.2 occurs and the Competing Product is not divested in the Territory within eighteen (18) months following the event described in Section 11.2, such notice of termination must be provided to USL within thirty (30) days after the expiration of such eighteen

 

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(18) month period. Should Orion commence Dealing with a Competing Product at any time after the Date of Agreement, USL shall have the right to terminate this Agreement on thirty (30) days written notice, provided that, if an event described in Section 11.2 occurs and the Competing Product is not divested in the Territory within eighteen (18) months following the event described in Section 11.2, such notice of termination must be provided to Orion within thirty (30) days after the expiration of such eighteen (18) month period. Such termination by Orion or USL (as applicable) shall be deemed, for purposes of Section 20, to be a termination due to an uncured material breach under Section 20.2.

 

“Dealing with a Competing Product” for purposes of this Agreement shall mean, directly or indirectly, developing, selling, marketing or manufacturing for sale in the Territory any Competing Product.

 

11.2                                           Acquisition of Competing Product. In the event that either Party acquires a Competing Product in the Territory as a result of a merger with, or acquisition of control over the business or assets of a Third Party, or is acquired by a Third Party who controls such a Competing Product, that party (a) must give prompt written notice of the date of closing of such transaction, and (b) shall have a period of eighteen (18) months following the closing of such merger, consolidation or acquisition to divest, or have divested, the Competing Product in the Territory before the other Party may exercise its termination rights stipulated for in Section 11.1 of this Agreement.

 

12                                                     TRADEMARKS

 

12.1                                           Ownership and Maintenance of Trademark and Internet Domain Names Incorporating the Trademark. The Product shall be marketed and distributed under either (a) the Divigel® trademark, which is owned by Orion (and, if used by USL in connection with the Product in the Territory, shall be registered (if not yet registered) in Canada, and maintained in the Territory by USL at its expense), or (b) another trademark that USL would develop and own, in either case subject to FDA approval for use of such trademark with the Product in the Territory. Orion hereby grants to USL an exclusive, non-transferable license to use the Divigel® Trademark in the Territory solely in connection with the marketing and distribution of Product under this Agreement. All rights not expressly granted in the Divigel® Trademark are reserved by Orion, and USL acknowledges that nothing in this Agreement shall give it any right, title or interest in or to any Orion trademarks other than the license to the Divigel® Trademark granted herein. Alternatively, USL, at its cost and expense, may develop, own and maintain a different trademark for use with the Product in the Territory.

 

If, during the Term, the Divigel® Trademark is used in connection with the Product, then upon expiration of the Term, USL shall have a fully-paid-up, irrevocable, perpetual and transferable license to use the Divigel® Trademark in the Territory. Such post-Term use shall be at the sole risk and expense of USL.

 

USL shall have the right, at its discretion, to seek registration for, and to register in its own name and for its own account with any interne domain name register any available domain name incorporating the Trademark for use within the Territory. Such use of an internet domain name shall be at the sole risk and expense of USL.

 

12.2                                           Registration of Other Marks. Each Party hereby agrees that at no time during the Term will it or any of its Affiliates attempt to use or register any trademarks, domain names or trade names confusingly similar to the Trademark or any domain names containing the same, or take any other action with a view to damaging the rights or goodwill in the Trademark, in the Territory.

 

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12.3                                           12.3 Third Party Infringers. Each Party agrees to promptly inform the other Party in writing of any of the following acts or claims which come to such Party’s notice:

 

(a)                                 any actual or perceived acts of unfair competition by any Third Party with respect to the Trademark;

 

(b)                                 any actual or apparent infringement of Trademark by any Third Party. 12.4 Prosecution of Infringers.

 

Should any Third Party infringe, or reasonably appear to be infringing the Trademark, USL may pursue Third Party, including (if necessary) bringing and directing in its own name, any legal or other action concerning the Trademark, including any settlement negotiation or proceeding with respect to such acts or infringements, at its own expense. Orion agrees, at USL’s expense, to render such reasonable assistance as may be requested by USL with respect to such actions and to consult with USL prior to any action being taken by Orion in that regard. Orion may be represented by counsel of its own selection at its own expense in any suit or proceeding brought to restrain or otherwise deal with such infringement by any Third Party, but may not independently initiate any such legal or other action without USL’s prior written consent. In the event that USL institutes any action against an infringer of any Trademark pursuant to this Section 12.4, it shall promptly notify Orion and keep Orion reasonably informed as to the developments of such suit.

 

12.4                                           Allocation of Recovery Against Third Party Infringer. All amounts recovered from a Third Party pursuant to this Section shall be used:

 

(a)                                 first to reimburse the reasonable costs and expenses (including reasonable attorney’s fees and costs) of the Parties in such action; and

 

(b)                                 second the balance shall belong to USL, provided that such balance shall be deemed Net Sales of USL in the quarter in which such balance is received, and USL shall pay Orion a Know-how Royalty on such Net Sales in accordance with the terms of Section 6.9 above.

 

Where the amounts recovered do not fully reimburse the costs and expenses described in (a) above, such amounts shall be paid to the Parties pro-rata to the costs and expenses incurred by the Parties.

 

12.5                                           No Rights to Other Trademarks. Each party hereby acknowledges that it does not have, and shall not acquire, any right or interest in any of the other party’s trademarks or trade names unless otherwise expressly provided in this Agreement. Each party agrees not to use any trade names or trademarks of the other party, except as provided in this Agreement or as otherwise specifically authorized by the other party in writing both as to the names or marks which may be used and as to the manner and prominence of use. USL hereby grants to Orion a non¬exclusive license to use USL’s trade names and/or trademarks, including without limitation the Trademark, as specified by USL in writing strictly for the purpose of such Product labeling and packaging and to use the USL logo and trademark to manufacture (or have manufactured) and supply the Product hereunder and, for the avoidance of doubt, no other license to, or right in, any of USL’s trade names, trademarks or other intellectual property rights is hereby granted to Orion. Each use of any trademark, trade name, logo or other intellectual property rights belonging to particular Party that is used on or in conjunction with the Product will inure to the benefit of that Party, and if any such use vests in the other Party any rights in the owning Party’s

 

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trademark, trade name, logo or other intellectual property rights, the other Party hereby transfers such right to the owning party or its designee upon request of the owing Party.

 

13                                                     PATENT OWNERSHIP AND PROSECUTION

 

13.1                                           Disclosure of Inventions. Each Party shall promptly disclose to the other Party the making, conception or reduction to practice of any inventions relating to the Product, whether or not patentable, by employees or others acting on behalf of such Party in the course of the Development of Product. All disclosures under this Section 13.1 shall be made at least sixty (60) days prior to any public disclosure of such invention or any required submission to government agencies in compliance with the requirements of government supported research.

 

13.2                                           USL and Orion shall consult with one another in good faith regarding a patent strategy for the Product in the Territory. Orion shall have the right, but no obligation, at its sole risk and at its expense, to pursue the initial filing of a potential Orion Patent, or support the continued prosecution of an Orion Patent. If Orion elects not to pursue the initial filing of a potential Orion Patent, or support the continued prosecution of an Orion Patent, Orion shall notify USL in writing promptly before the date required for the deadline date by which an action must be taken to establish or preserve an Orion Patent right. USL shall then have the right, but no obligation, at its sole risk and at its expense, to pursue the filing or support the continued prosecution of such Orion Patent. If USL elects to pursue such filing or continue such support, then it shall notify Orion of such election, and Orion shall promptly assign to USL, for a nominal consideration (the receipt and sufficiency of which is hereby acknowledged), all of its right, title and interest in such Orion Patent; provided however, Orion and its Affiliates shall have a perpetual, royalty-free, non-exclusive, non-sublicensable right under such assigned Orion Patent for use in the Territory which, during the Term shall be for the limited purpose of Orion’s performance under this Agreement. In the event patent applications are filed covering the Product, its formulation or manufacture, in the Territory the Parties will consult with one another as to the desired scope of coverage of claims in the patent applications. The Party that is not prosecuting the patent application (the “Non-Prosecuting Party”) shall have reasonable opportunities to offer the party prosecuting the patent application (the “Prosecuting Party”) comments with respect to patent applications under the Patent Rights in the Territory. The Prosecuting Party shall keep the Non-Prosecuting Party fully advised of the status of patent applications and the patents in the Patent Rights by giving the Non-Prosecuting complete information with respect thereto, including but not limited to, copies of all patent applications, office actions, amendments, copies of issued patents and copies of notices from the United States Patent and Trademark Office. The Prosecuting Party shall give the Non-Prosecuting Party reasonable written notice before the issuance of an allowed patent application on a Patent Right of Prosecuting Party’s intentions regarding the filing of continuations and/or divisionals.

 

13.3                                           Cooperation. Each of Orion and USL shall make available to the other Party (or to the other Party’s authorized attorneys, agents or representatives) at the other Party’s request and expense, its employees, agents or consultants to the extent reasonably necessary to enable the appropriate Party to exercise its rights hereunder in relation to Patent Rights for periods of time sufficient for such Party to obtain the necessary assistance from such personnel. Where appropriate, each of the Party shall sign or cause to have signed all documents necessary for such purposes.

 

13.4                                           Post-term Royalties. Following the expiration of the Term, USL shall pay Orion, in consideration for USL’s having obtained a license under Orion Patent Rights (if any), Proprietary Information and the Divigel® Trademark (if the Divigel® Trademark is used for the Product in the Territory) for purposes of this Agreement, a running residual know-how and

 

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Trademark use royalty of [***] of Net Sales of Product in the Territory hereunder for as long as such Products are sold under the Divigel® Trademark, and [***] of Net Sales of Product in the Territory hereunder not under the Divigel® Trademark. Any successor to USL by reason of merger acquisition or otherwise shall expressly be bound by the royalty obligations of USL under this Agreement. Notwithstanding anything contained herein to the contrary, no royalty shall be payable pursuant to this Section 13.4 in any circumstance whatsoever if, after expiration of the Term, Orion commences sale of a generic Product in the Territory (it being understood that Orion may, after expiration of the Term, develop and sell a generic Product in the Territory, under its own label and own Regulatory Approval (without reference rights to USL’s Product NDA)).

 

13.5                                           Payment of Post-Term Royalties. The royalties payable pursuant to Section 13.4 shall be calculated and reported to Orion in accordance with Section 6.10, and paid by USL in accordance with Section 6.10.

 

14                                                     PATENT INFRINGEMENT MATTERS

 

14.1                                           Notice of Infringement. Each Party agrees to promptly inform the other Party in writing of any of the following acts or claims which come to such Party’s notice:

 

(a)                                 any actual or apparent infringement in the Territory of any Orion Patent Rights by any Third Party as well as any Third Party claims or threatened claims of invalidity with respect to any Orion Patent Rights; and

 

(b)                                 any lawsuits, claims or threatened claims of alleged infringement of a Third Party’s intellectual property rights made by any Third Party in the Territory involving Product, or its manufacture, use or sale.

 

(c)                                  Any “Paragraph N Certification Notice” with respect to the Product (it being understood that either Party receiving a Paragraph N Notice shall immediately notify the other Party).

 

14.2                                           Prosecution of Infringers.

 

(a)                                 Upon giving or receiving notice of any alleged Third Party infringer, USL shall promptly, but in any event within the Applicable Period, advise Orion if it intends to initiate action with respect to the alleged infringer. If USL advises Orion that it does not desire to initiate such action, Orion may, but has no obligation to, do so. The “Applicable Period” shall, in the context of a Paragraph IV Certification by a Third Party, mean (a) a period of twenty-one (21) days after USL receives notice of the Third Party Paragraph IV certification, and (b) shall otherwise mean a period of thirty (30) days after giving or receiving notice under Section 14.1 of this Agreement of the alleged Third Party infringement.

 

(b)                                 The party initiating the action will bear its expense, and the other party will cooperate, at the expense (with respect to out-of-pocket expenses only) of the party initiating the action.

 

14.3                                           Allocation of Recovery Against Third Party Infringer. Any recovery in such action against the third party infringer shall first be distributed to reimburse the reasonable out of pocket expenses of the Party that bore the enforcement action. The balance of any recovery shall belong to USL,

 

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as the party of commercial interest in the Territory, whose damages will be the basis of any recovery in the enforcement action. The amount of that balance will, however, be deemed Net Sales of USL, and Know-how Royalties shall be paid to Orion thereon in accordance with Sections 6.9 or 13.4 (as applicable) above.

 

14.4                                           Potential Violations of Court Orders. In the event of patent infringement litigation in the United States or Canada (as the case may be) involving a claim that the Product infringes the patent rights of a third party, then USL and/or its Affiliates or sublicensees may be requested by Orion to consider suspension of the import, distribution, marketing, sale, use or other activities in connection with the Product in that country to the extent this may be necessary based upon advice of Orion’s outside legal counsel in order to (i) comply with any court ordered injunction, or an arbitrator(s) award or order whether interim or final or (ii) prevent or limit a material level of damages or liability to Orion with respect to such third party. Such request by Orion and compliance by USL and its Affiliates (and/or its sublicensees), if agreed, (1) shall be deemed a temporary suspension of USL’s and/or its Affiliates’ or sublicensees’ obligations to market and sell the Product in the Territory, including any obligation under Section 9 of this Agreement, but (2) shall not excuse Orion’s obligations to deliver for sale in the Territory by USL, its Affiliates and/or any sublicensees, Product that does not infringe the patent rights of any Third Party, and (3) shall be a material breach of this Agreement by Orion; and USL, its Affiliates and sublicensees shall be deemed not to have waived such breach (or release Orion from any liability with respect to such breach) even if USL, its Affiliates and/or sublicensees comply with Orion’s request.

 

14.5                                           Potential Termination for Infringement. Should Orion or USL or any of its or their Affiliates be prevented by reason of an adverse, non-appealable or unappealed court judgment or arbitral award against it from selling or supplying the Product in a particular country in the Territory due to infringement liability which would arise as a result of such decision(s), then (a) USL may (in addition to other remedies) terminate this Agreement (effective as of such time as stated in USL’s written notice of termination) in whole or with respect only to the country in the Territory in which the judgment or award applies and such termination shall be deemed a termination for uncured breach by Orion under Section 20.2.1 of this Agreement; and (b) Orion may also terminate this Agreement upon thirty (30) days prior written notice, provided that (1) such termination shall be with respect only to the country in the Territory in which the judgment or award applies (unless USL has given its prior written consent to permit the termination to be effective with respect to this Agreement in whole); and (2) any such termination by Orion shall be deemed a material breach by Orion and shall be treated the same as termination by USL for uncured breach by Orion under Section 20.2.1 of this Agreement, and Orion shall have all responsibility and liability, and USL all rights and remedies, subject to Section 16.13, as arise in the case of Orion’s material breach of its obligations to deliver for sale in the Territory by USL, its Affiliates and/or any sublicensees, Product that does not infringe the patent rights of any Third Party.

 

14.6                                           Indemnification for Infringement of Third Party Intellectual Property Rights.

 

14.6.1                                 USL shall defend, indemnify and hold Orion Indemnified Persons (as defined in Section 16.10(a) below) harmless from and against any and all liabilities, damages, claims, costs or expenses (including reasonable attorneys’ fees) arising out of any Third Party claim, suit, demand or action for any economic or property loss or damage, personal injury or death to the proportionate extent due to any claim that the use of a Trademark in connection with the Product violates the intellectual property rights of any Third Party. USL’s obligations under this Section 14.6.1 are conditioned upon the terms set forth in Section 16.10(b).

 

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14.6.2                                 Orion shall defend, indemnify and hold the USL Indemnified Persons (as defined in Section 16.11(a) below) harmless from and against any and all liabilities, damages, claims, costs, or expenses (including reasonable attorneys’ fees) arising out of any Third Party claim, demand, suit or action for any economic or property loss or damage or personal injury or death to the proportionate extent due to any claim that the Product violates the intellectual property rights of any Third Party except to the proportionate extent that any such claimed infringement arises the use of a Trademark used in connection with the Product. Orion’s obligations under this Section 14.6.2 are conditioned upon the terms set forth in Section 16.11(b). If Orion asserts a counterclaim against any such Third Party and obtains a recovery on such counterclaim against such Third Party, such recovery in such action shall first be distributed to reimburse the reasonable out of pocket expenses of Orion in such action. The balance of any recovery shall belong to USL, as the party of commercial interest in the Territory, whose damages will be the basis of any recovery in such counterclaim. The amount of that balance will, however, be deemed Net Sales of USL, and Know-how Royalties shall be paid to Orion thereon in accordance with Sections 6.9 or 13.4 (as applicable) above.

 

15                                                     LIAISON AND REPORTS - MARKETING AND SALES REPORTS, FORECASTS

 

15.1                                           Marketing Plans. USL shall furnish to Orion, on a confidential basis, a draft launch plan for the Product timely in advance of the First Commercial Sale. The parties shall meet annually at USL (unless otherwise agreed upon by the Parties), on or about the anniversary of the First Commercial Sale, to discuss, on a confidential basis, USL’s annual marketing and sales plan for Product, including USL’s marketing strategy for the Product, including key promotional messages, as well as anticipated Net Sales for the upcoming Year. At such meeting, the Parties shall also review USL’s main marketing activities for the prior year, as well as the market share and sales performance of Product, including internally developed information and reports (to the extent existing in the ordinary course of USL’s business) regarding (a) market share development of Product in the Territory during the prior Year, as compared to the prior Year, (b) actual Net Sales during the prior Year as compared to anticipated/budgeted Net Sales in the Territory for that Year, (c) the market share and sales performance of Product compared with competing products in the Territory, market performance and trends for the class of products in which Product competes in the Territory, as well as a listing of potential competing products in the Territory of which USL is aware, and (d) a summary of prescription data regarding total and new prescriptions for Product in the Territory during the prior Year. It is understood that nothing in this Section 15.1 shall require USL to provide Orion with any information that USL has not already generated for its own internal reporting purposes or to provide any information in a format other than that used for its own purposes.

 

16                                                     PRODUCT SPECIFICATIONS, QUALITY, WARRANTIES, INDEMNITIES

 

16.1                                           The Parties agree on the following with respect to issues related to each Product’s specifications and quality assurance, subject to any future, mutually agreed amendment(s) hereto that may be made.

 

16.2                                           Product Warranties.

 

16.2.1                                 Orion represents and warrants to USL that any Product supplied to USL under this Agreement:

 

(a)                                 was manufactured, labeled (to the extent of Orion’s responsibility as described in Section 10.7 above) packaged, tested and shipped in accordance with all laws and regulations applicable to manufacture of Product in the country of manufacture and in

 

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accordance with CGMP, the Product NDA and the Act. Orion further warrants that, to the extent applicable, the Product supplied to USL shall be manufactured in a facility approved in the NDA, and (to the extent applicable) as of the date of shipment are not adulterated or misbranded (within the meaning of the Act), and are not an article which may not, under the provisions of Section 404, 505 or 513 of the Act, be introduced in interstate commerce; and

 

(b)                                 conforms to the Specifications from the time of delivery to USL until the end of the specified Product shelf life, provided that it is handled and stored properly and in accordance with the pertaining instructions.

 

NO OTHER WARRANTIES OR REPRESENTATIONS, EXPRESS OR IMPLIED, INCLUDING FITNESS FOR A PARTICULAR PURPOSE AND MERCHANTABILITY, ARE MADE OR WILL BE DEEMED TO HAVE BEEN MADE BY ORION REGARDING THE PRODUCT.

 

16.2.2                                 Each of Orion and USL represents and warrants that neither it nor any of its Affiliates have been debarred or is subject to debarment and will not use in any capacity, in connection with the services to be performed under this Agreement, any person who has been debarred pursuant to Section 306 of the Act, and that (in the case of Orion) its manufacturing facilities conform, and shall continue to conform throughout the term of this Agreement, in all respects to applicable law and regulations governing such facilities.

 

16.3                                           Changes to Specifications. Orion will not modify any of the Specifications, specifications for any of the raw materials used in producing the Product (including without limitation the Compound), or any process or procedure used to manufacture the same, or change the equipment used in the manufacture of Product (except for repair or replacement of existing equipment), or change any of its suppliers of any raw materials used in producing Product, in each case without obtaining the prior written consent of USL, such consent not to be unreasonably withheld, and any approvals required for purposes of obtaining or maintaining any Regulatory Approval of the Product affected by such modification. Any such change shall be implemented only after all necessary consents and approvals of, and notifications to, the FDA have been obtained or made, and shall be implemented in a manner that does not impact Orion’s ability to supply Product to USL in accordance with the provisions of Section 6. Orion shall be solely responsible for all costs and expenses incurred in making any such changes or modifications, except to the extent such changes or modifications have been requested by USL, in which case such costs shall be borne by USL; provided further that should such changes result in economic benefit for Orion the allocation of such costs and expenses between the Parties shall be separately agreed, as reasonable.

 

The Parties acknowledge that the Specifications for Product attached hereto as Schedule 4 are preliminary and the Parties shall work in good faith to finalize such Specifications at the appropriate time; provided, however, for clarity, such final Specifications shall be subject to FDA approval.

 

16.4                                           Certificate of Analysis. Orion shall deliver with each shipment of Product a certificate of analysis, accompanied by a statement that the batch was manufactured according to the Quality Assurance Agreement, together with any other batch related records specified in the Quality Assurance Agreement. Without limitation, the certificate of analysis shall set forth the items tested, specifications and test results for each lot delivered, all in a manner which complies with the NDA, the Act and other applicable laws and regulatory requirements. Batch records for that

 

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shipment (including all deviation reports and investigations) will, within seven (7) working days after release of the Product, be shipped to USL’s Quality Assurance Unit for review.

 

16.5                                           Analytical Methods and Stability Studies. Prior to Orion’s first delivery of Product, Orion will provide USL with the relevant analytical test methods information for Product to enable USL to exercise its inspection rights under Section 16.6 below and/or to qualify- as a back-up manufacturer of bulk gel/gel sachets of Product, which test methods shall be deemed Confidential Information of Orion. Orion shall be responsible for conducting, at its expense, all required stability studies for Product (except for studies relating to Product that is not manufactured by Orion). Without limitation, Orion must perform its standard stability test program as committed to in the Product NDA and as defined in Orion’s SOPs, the applicable FDA guidelines and ICH. Orion will provide USL with a copy of its stability reports, as they become available, for each Product. Orion will within, three working (3) days, after a confirmed Out Of Specification (“OOS”) result in the stability testing for a Product, and prior to re-testing for stability, notify USL of those results. In addition, to the extent applicable, Orion will undertake all validation work as may be required by the NDA, CGMP, the Act or other applicable law, Orion’s standard operating procedures, or as otherwise agreed upon by the parties.

 

16.6                                           Inspection of Batches.

 

(a)                                 USL shall inspect and analyze each batch of Product delivered after receipt. If USL reasonably believes the delivered Product does not meet Specifications, or has any other defect, USL shall notify Orion in writing of any such claims within forty-five (45) days after USL’s receipt of Product and all documentation as provided in this Agreement or the Quality Assurance Agreement. In the event USL does not notify Orion of any such defect within the applicable forty-five (45) day period, USL shall be deemed to have accepted the shipment, except for latent defects that could not have been reasonably discovered upon said inspection. Acceptance will not affect USL’s rights if any certification provided by Orion is false or inaccurate.

 

Any claims regarding delivered Product shall specify in reasonable detail the nature and basis for the claim and cite relevant Orion control numbers or other information to enable specific identification of Product involved. All claims made by USL regarding quantity or quality of Product shall be handled on a case by case basis during which time Orion shall have the right to first inspect any delivery of Product involved before being required to take any action with respect thereto. USL shall not be required to accept Product which has an actual shelf life after delivery from Orion of less than [***] of the shelf-life approved in the Regulatory Approval for the Product or [***], whichever is longer.

 

(b)                                 Orion shall promptly review any such claim of Product non-conformity timely made by USL within seven (7) days of being notified of same, or more expediently if the FDA requires a more prompt response from Orion or USL.

 

If such review and testing by Orion confirms that a delivery of Product being objected to by USL does not meet the required Specifications, or was otherwise defective, then USL shall dispose of or return such delivery as Orion shall direct in writing, at Orion’s expense, and Orion shall use all reasonable efforts to replace, at Orion’s expense, that rejected Product with conforming Product as soon as possible, but not later than sixty (60) days after USL’s notice of rejection.

 

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Orion shall grant USL full credit for the original invoiced amount (plus interest thereon from the date paid through the date credited at a rate of [***] annually) for any rejected Product paid, plus any additional reasonable out-of-pocket expenses incurred by USL in the transportation and importation, inspection, and disposal of such defective or non-conforming Product. If the Parties fail to agree as to whether a delivered quantity meets its required Specifications, or was otherwise defective, then the Parties agree to have the batch in dispute tested and further analyzed by a recognized independent testing laboratory located in the Territory selected by agreement of the Parties. Should said laboratory’s testing determine that the required Specifications were not met, or the Product was otherwise defective, then their decision shall be deemed final and in such case Orion will bear the costs of said independent laboratory’s testing. If said quantity of Product is determined by said independent laboratory to have met its Specifications, and to have not otherwise been defective, then USL shall bear all costs of the independent laboratory testing.

 

Orion shall deliver a replacement quantity of Product to USL meeting required Specifications even while a dispute as described the preceding paragraph is awaiting resolution by such testing laboratory (it being understood that such delivery of replacement Product will not impair any claims or defenses relating to said dispute).

 

16.7                                           Storage Conditions. USL, its Affiliates and Agents dealing with Product shall ensure that Product under it or their control is at all times properly stored under conditions that will not adversely affect its quality or Specifications or actual shelf life required under an applicable Regulatory Approval.

 

16.8                                           Inspection Rights. Upon reasonable prior notice, Orion shall permit USL to review periodically Orion’s quality control procedures and records, during normal business hours and not more than once per Year (absent unusual circumstances when more frequent access is reasonable), in order to assure satisfaction with Orion’s compliance with the requirements of this Agreement, and the Quality Assurance Agreement. To the extent reasonably required in order for USL to comply with applicable laws and regulations or verify compliance with this Agreement, USL’s personnel may visit Orion’s production facilities used to manufacture or store Product upon reasonable prior notice. Such visits shall be conducted in a reasonable manner and shall be limited to the equipment, records, production facilities and laboratories pertinent to the manufacture, testing, and storage of the Product.                Orion shall, reasonably cooperate with USL representatives who may visit Orion’s production facility as provided in this Section 16.8. In addition, USL shall be given reasonable opportunity, to assist Orion, at USL’s expense, Orion in preparation for a pre-approval inspection by the FDA.

 

16.9                                           Records. USL and Regulatory Authorities shall have the right to audit Orion’s records relating to its manufacture of Product under this Agreement. Orion shall maintain reserve samples, all batch and other manufacturing and analytical records, all records of shipments of the Product, and all validation data relating to the Product and other applicable records, to the extent and for the time periods required by applicable laws and regulations, and shall make such data available to USL and Regulatory Authorities upon USL’s reasonable request or if required by law. Orion shall have the corresponding rights as USL under this Section and USL the corresponding obligations as Orion under this Section with respect to such matters in the event USL exercises its back-up manufacturing rights for Product under this Agreement.

 

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16.10                                    Orion Indemnification.

 

(a)                                 USL shall defend, indemnify and hold Orion, its Affiliates, and the officers, directors and employees of each (collectively, the “Orion Indemnified Persons”) harmless from and against any and all liabilities, damages, claims, costs or expenses (including reasonable attorneys fees) arising out of any Third Party claim, suit, demand or action for any economic or property loss or damage, personal injury or death to the proportionate extent due to (1) any breach by USL of its warranties or representations under or related to this Agreement; (ii) any breach by USL of any of the other terms of this Agreement; (iii) any breach of or noncompliance, by USL, its agents, representatives, consultants or contractors, in any respect, with applicable laws or regulations; or (iv) any negligent act or omission, or intentional act or omission of misconduct, on the part of USL, its agents or representatives.

 

(b)                                 Conditions to be met for the above indemnification obligation to become applicable are that (1) Orion shall notify USL promptly in writing of any claim, suit, demand or action, including reasonable details thereof as are available to Orion which may give rise to an indemnification obligation on the part of USL hereunder, (2) USL is allowed to timely undertake sole control of the defense of any such claim, suit or action against it, including all negotiations for the settlement or compromise of such claim, suit or action at its sole expense, and, (3) Orion renders such reasonable assistance, information, cooperation and authority to permit USL to defend such claim, suit or action, it being agreed that any reasonable out-of-pocket expenses incurred by Orion in rendering the same shall be borne or reimbursed promptly by USL. USL shall not be liable for any litigation costs or expenses incurred by the Orion Indemnified Persons without USL’s prior written authorization. In addition, USL shall not be responsible for the indemnification or defense of any claims compromised or settled without its prior written consent.

 

16.11                                    USL Indemnification.

 

(a)                                 Orion shall defend, indemnify and hold USL, its Affiliates and the officers, directors, and employees of each (collectively, the “USL Indemnified Persons”), harmless from and against any and all liabilities, damages, claims, costs, or expenses (including reasonable attorneys fees) arising out of any Third Party claim, demand, suit or action for any economic or property loss or damage or personal injury or death the proportionate extent due to (i) any breach by Orion of its warranties or representations under or related to this Agreement; (ii) any breach by Orion of any of the other terms of this Agreement; (iii) any breach of or noncompliance, by Orion, its agents, representatives, consultants or contractors, in any respect, with applicable laws or regulations; or (iv) any negligent act or omission, or intentional act or omission of misconduct, on the part of Orion, its agents or representatives.

 

(b)                                 Conditions to be met for the above indemnification obligation to become applicable are that (1) USL shall notify Orion promptly in writing of any claim, suit, demand or action, including reasonable details thereof available to USL, which may give rise to an obligation on the part of Orion hereunder, (2) Orion is allowed to timely undertake the sole control of the defense of any such claim, suit or action made against it, including all negotiations for the settlement or compromise of such claim, suit or action at its sole expense, and (3) USL renders such reasonable assistance, information, cooperation and authority to permit Orion to defend such action, it being agreed that any reasonable out-

 

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of-pocket expenses incurred by USL in rendering the same shall be borne or reimbursed promptly by Orion. Orion shall not be liable for any litigation costs or expenses incurred by the USL Indemnified Persons without Orion’s prior written authorization. In addition, Orion shall not be responsible for the indemnification or defense of any claims compromised or settled without its prior written consent.

 

16.12                                    Insurance. Each Party shall obtain and maintain reasonable product liability insurance with respect to Product and appropriate comprehensive general liability insurance, which may be self-insurance. Each party shall maintain product liability insurance in an amount not less than [***] United States dollars (US$[***]); in the aggregate. At the inception of this Agreement and thereafter periodically upon request, each Party shall furnish the other with a certificate of insurance evidencing that such insurance coverage is in force. Each Party shall diligently pursue recovery of insurance proceeds from a Third Party when a claim arises.

 

16.13                                    Limitation of Liability. Except as otherwise and expressly provided for in this Agreement, in no event shall either Party be held liable to the other Party, its Affiliate(s), or any “Contractual Third Party” (except for a Contractual Third Party claim for damage that may be indemnifiable (i) under Section 14.6.2, or (ii) under Section 16.10(a) or 16.11(a) (as applicable) for personal injury or death), for lost profits or, without limitation, any other indirect, incidental, consequential or punitive damages incurred by the other Party or its Affiliates, or any Contractual Third Party (except as stated above in this Section 16.13), and arising out of or in connection with this Agreement, or any breach thereof in excess (in the aggregate) of the “Applicable Consequential Damages Cap.” For purposes of this Agreement “Applicable Consequential Damages Cap” shall mean with respect to such indirect, incidental, consequential or punitive damages owed by either Party to the other, an amount equal to [***] of the aggregate Minimum Net Sales for Years 1 through 5 as stated in Section 7.2, except with respect to such indirect, incidental, consequential or punitive damages owed by Orion to USL arising from or related to any failure to deliver or suspension of delivery of Product by Orion in connection with a claim that the Product infringes a Third Party’s intellectual property rights, in which case the “Applicable Consequential Damages Cap” shall equal [***] of the aggregate Minimum Net Sales for Years I through 5 as stated in Section 7.2. In addition, any claim by Orion for Shortfall Royalties shall be deemed a claim for consequential damages (rather than direct damages). Other than as stated above in this Section 16.13, nothing in this Agreement is intended to, nor shall it, limit or restrict the obligation of either party to indemnify the other in connection with Third Party claims as provided in this Agreement. A “Contractual Third Party” means a Third Party that, with respect to a Party, (A) is such Party’s Agent, sublicensee, Third Party private label distributor, or (B) otherwise has a contractual relationship with such Party, its Agent, sublicensee or Third Party private label distributor related to the manufacture, testing, development, or sale, distribution, supply or purchase in the Territory, of the Product.

 

16.14                                    Product Recalls. In the event (i) the FDA issues a request, directive or order that any Product be recalled, or (ii) a court of competent jurisdiction orders such a recall, or (iii) Orion reasonably determines, after consultation with USL, that any Product should be recalled because the Product does not conform to Specifications, or (iv) USL, after consultation with Orion, reasonably determines that any Product should be recalled for any reason, the parties will take all appropriate corrective actions reasonably requested by the other party or by the FDA. In the event that any such recall results from the breach of Orion’ warranties or obligations under this Agreement, or Orion is otherwise responsible for the recall, Orion will be responsible for all of the reasonable expenses of the recall. In the event that any such recall results from the breach of USL’s warranties or obligations under this Agreement, or USL is otherwise responsible for the recall, USL will be responsible for all of the reasonable expenses of the recall. For the

 

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purposes of this Agreement, the reasonable expenses of the recall include, without limitation, all expenses for notification of customers and the destruction or return of the recalled Product, as well as all reasonable out-of-pocket costs incurred by Orion and USL in connection with any corrective action taken by Orion and USL. USL will conduct the recall process in accordance with applicable law and regulation, as well as USL’s standard operating procedures. USL and Orion will fully cooperate with the other party to assist in the recall process as reasonably necessary to complete the process.

 

16.15                                    Complaints. Each Party agrees to provide the other Party with such patient experience data as are available, consistent with applicable law, to each Party to assist the other Party in responding to “complaints” pertaining to Product characteristics; i.e. patient complaints of sub-potency, unpleasant taste and the like. Orion will be responsible for conducting investigations for all complaints related to Product manufacture, primary packaging or nonconformance to the Specifications. Orion will report the results of such investigation within thirty (30) days after notification of the complaint. All other complaints such as those relating to secondary packaging features or other Product related matters will be the responsibility of USL to address.

 

17                                                     CONFIDENTIALITY

 

17.1                                           USL Acknowledgement. USL hereby acknowledges that certain Orion Proprietary Information which may include confidential information of Orion’s principals and/or licensors, relating without limitation to the Product, other Orion products, and the plans, activities and business of Orion may be provided to USL, its Affiliates and/or its Agents under this Agreement.

 

17.2                                           Orion Acknowledgement. Orion hereby acknowledges that USL, its Affiliates and/or Agents either have or may develop certain confidential proprietary information relating to their sales and marketing plans and activities for the Product in the Territory or relating, without limitation, to USL’s other business and activities that may be provided to Orion in connection with the Parties’ collaboration and activities under this Agreement.

 

17.3                                           Confidentiality Obligations. A Party shall not disclose Confidential Information of the other Party to any Third Parties or otherwise use such Confidential Information, except to the extent such use or disclosure is expressly permitted by the terms of this Agreement, or required or reasonably necessary for proper performance of this Agreement, or the exercise of its rights under this Agreement. By way of example, USL or its Affiliates may disclose Orion’s Confidential Information to health or Regulatory Authorities in the Territory to the extent necessary to comply with any laws applicable to it as distributor of Product therein or in order to obtain Regulatory Approval for Product

 

17.4                                           Limitation on Disclosures. USL and Orion and their respective Affiliates may divulge each other’s Confidential Information to only those of their, and their Affiliates’ employees and such permitted independent contractors, agents or other Third Parties who have a bona fide “need to know” to permit USL or Orion to properly perform their obligations or exercise their rights under this Agreement, provided such persons are first bound by confidentiality undertakings that are materially no less stringent and consistent with the receiving Party’s confidentiality obligations hereunder.

 

17.5                                           Exceptions to Confidentiality Obligations. Each Party’s confidentiality undertakings pursuant to this Agreement shall not apply to any information of the other Party:

 

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(a)                                 which at the time of disclosure is or later has come into the public domain by publication or otherwise through no fault of the receiving Party; or

 

(b)                                 which the receiving Party’s documentation demonstrates to have been in the receiving Party’s possession prior to disclosure of it from the disclosing Party; or

 

(c)                                  which is received by the receiving Party from a Third Party in possession of same and not bound by any confidentiality undertaking with respect to said information to the disclosing Party, or to any Affiliate, licensor, licensee, distributor or agent of the disclosing Party; or

 

(d)                                 which is independently developed by the receiving Party without access to the disclosing Party’s Confidential Information; or

 

(e)                                  which a Party is required by law to disclose provided that, prior to such disclosure, the receiving Party promptly notifies the disclosing Party in writing of any such obligation and affords the disclosing Party the opportunity to oppose such order; or

 

(f)                                   which a Party is required to disclose or to use to reasonably defend its position under trial or judicial or arbitration proceedings or to disclose to its attorneys of record or retained experts in connection with same, provided such disclosure is on a confidential basis, where possible, and restricted to the minimum extent required and to such persons solely for such purposes.

 

17.6                                           Duration of Confidentiality Obligations. The confidentiality obligations of both Parties under this Section 17 shall remain in effect with respect to any particular item of Confidential Information until [***] from the expiry or earlier termination of this Agreement.

 

17.7                                           Terms of Agreement. Except as permitted by the foregoing provisions or as otherwise required by law or the rules of any relevant stock exchange, the Parties shall not disclose any terms or conditions of this Agreement to any Third Party without the prior consent of the other Party; provided that each Party shall be entitled to disclose the terms of this Agreement without such consent to its advisors and financing sources on the condition that such entities or persons agree to keep such terms confidential for the same time periods and to the same extent as such Party is required to keep such terms confidential. Each Party shall give the other Party a reasonable opportunity to review all filings with any stock exchange describing the terms of this Agreement prior to submission of such filings, and shall give due consideration to any reasonable comments by the non-filing Party relating to such filing, including without limitation the provisions of this Agreement for which confidential treatment should be sought.

 

17.8                                           Termination of Prior Agreement. The Parties agree that as of the Date of Agreement the Confidentiality Agreement dated as of January 7, 2003, between USL and Orion is hereby terminated and superseded by the provisions of this Agreement, and any disclosures made under the terms of that confidentiality agreement shall be deemed to have been made under the terms of this Agreement, notwithstanding that the information was disclosed prior to the Date of Agreement.

 

18                                                     FORCE MAJEURE

 

18.1                                           No Liability for Force Majeure. Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

fulfilling or performing any term of this Agreement to the extent such failure or delay is caused by or results from causes that are beyond the reasonable control of the affected Party and that could not have been avoided by the exercise of reasonable diligence, provided, however, that the Party so affected shall use commercially reasonable and diligent efforts to avoid or remove or mitigate such causes of non-performance, and shall continue performance with reasonable dispatch wherever such causes are removed. In the event of a force majeure effecting either party’s performance, that party will allocate materials, personnel and resources equitably among all of Orion, USL and Orion’s other customers and commitments.

 

18.2                                           Notification of Force Majeure. The Party so affected shall give prompt written notice to the other Party of the nature and date of commencement of the force majeure and expected duration.

 

19                                                     SEVERABILITY OF CLAUSES

 

In case one or more of the provisions contained in this Agreement shall, for any reason, be held invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision of this Agreement, but this Agreement shall be construed by limiting such invalid, illegal or unenforceable provision, or if such is not possible, by deleting such invalid, illegal or unenforceable provision from this Agreement; provided that should this Agreement as a result of any such deleting not any more reasonably correspond to the good faith intent of the Parties, either Party may propose to the other Party amendments also to the other provisions of this Agreement in order to have the Agreement correspond to such good faith intent and negotiate in good faith on such amendment(s).

 

20                                                     RIGHT TO EARLIER TERMINATION

 

20.1                                           Insolvency. Either of the Parties shall have the right, without prejudice to any other rights or remedies or other relief available to it under the governing law and this Agreement, to terminate this Agreement forthwith if the other Party becomes insolvent, is adjudged bankrupt, applies for judicial or extra-judicial settlement with its creditors, makes an assignment for the benefit of its creditors, voluntarily files for bankruptcy or has a receiver or trustee or the like in bankruptcy appointed by reason of its insolvency, or in the event an involuntary bankruptcy action is filed against the other Party and not dismissed within ninety (90) days, or if the other Party becomes the subject of liquidation or dissolution proceedings or otherwise discontinues business.

 

20.2                                           Material Breach.

 

20.2.1                                 In the event a Party materially breaches any of the terms or conditions of this Agreement (the “Defaulting Party”) the other Party (the “Non-Defaulting Party”) may give written notice of such breach to the Defaulting Party, specifying the nature of the material breach and requesting a cure (the “Default Notice”). If the Defaulting Party fails to fully cure or to take appropriate action to cure such breach within thirty (30) days of receipt of the Default Notice from the Non-Defaulting Party, then the Non-Defaulting Party may terminate this Agreement effective immediately upon written notice of termination to the Defaulting Party provided such termination notice must be given within thirty (30) days after the expiration of the applicable cure period. Termination under this Section 20.2.1 shall be automatically stayed for the duration of any proceedings initiated under Section 25. Notwithstanding anything contained in this Agreement to the contrary, in the event of an uncured material breach by USI, with respect to its performance under this Agreement only in Canada, Orion may terminate this Agreement only with respect to Canada, and thereafter (1) the term “Territory” shall exclude Canada, and

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

(2) the Agreement shall remain in force and effect with respect to the United States, its Territories and possessions.

 

20.2.2                                 In the event of termination by USL under Section 20.2.1, USL shall have an ongoing license for the Product in the Territory, including the right to manufacture, as further contemplated in Section 20.9 below.

 

20.2.3                                 In the event of termination by Orion under Section 20.2.1, USL shall, upon Orion’s request, promptly, and without charge to Orion, execute assignments (in form reasonably acceptable to Orion) transferring to Orion the following: (i) all development data and other information arising out of or in connection with the development work conducted in accordance with the Development Plan by or on behalf of USL pursuant to this Agreement, including without limitation, copies of its correspondence with Regulatory Authorities regarding the same, a copy of all information in its possession or under its control that is contained in its regulatory and/or safety databases relating to the Product, including all materials prepared by USL relating to the Product NDA for the Product for the Territory, all in the format then currently maintained by USL; (ii) all Regulatory Approvals for the Product, including but not limited to the NDA, and any applications therefor, in Territory; and (iii) at the request of Orion any ongoing development work in relation to the Product and the management of any studies forming part of the Development Plan being carried out by or on behalf of USL at the date of termination. In addition, USL will grant Orion a royalty-free, nonexclusive license under the USL Patent Rights in the Territory, if any, to the extent they relate specifically to the Product, for the purpose of enabling Orion to make, have made, use, import, sell, offer to sell and import Product in the Field in the Territory.

 

Moreover, USL shall use commercially reasonable efforts to provide, at Orion’s expense, all cooperation and assistance reasonably requested by Orion to enable Orion (or its nominee) to assume with as little disruption as possible, the Development and commercialization of Product in the Field in the Territory. Such cooperation and assistance shall be provided as promptly as possible (having regard to the nature of the cooperation or assistance requested) and shall include without limitation the following, for a period of eighteen (18) months following termination, USL shall in response to requests from Orion or its nominee, continue to use commercially reasonable efforts to provide such information, advice and assistance relating to the Product as may be reasonably required from time to time.

 

The Parties shall use commercially reasonable efforts to complete the transition of the Development and commercialization of the Product from USL to Orion pursuant to this Section 20.2.3 as soon as is reasonably possible.

 

20.3                                           Termination Due to Shortfall.

 

20.3.1                                 Orion may terminate this Agreement in accordance with and subject to Section 7.5 and USL may terminate this Agreement in accordance with and subject to Section 7.4. In the event that this Agreement is terminated pursuant to Section 7.5 or Section 7.4, Section 20.2.3 shall apply subject to Section 20.3.2.

 

20.3.2                                 If USL terminates this Agreement pursuant to Section 7.4, or Orion terminates this Agreement pursuant to Section 7.5, and within two years after the date of termination enters into an agreement granting a Third Party rights to distribute the Product in the Territory, Orion must give USL’s independent accountants a copy of such agreement (the “Third Party Agreement”). The independent accountant shall not disclose the terms of the Third Party Agreement to USL

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

unless (a) the terms of the Third Party Agreement are more favorable than the terms of this Agreement, including, without limitation, with respect to royalty rate, supply price, minimum obligations requirements, or other material terms, or (b) in the case of termination under Section 7.4, if the parties entered into good faith negotiations to adjust the Minimum Net Sales in accordance with Section 7.4, the terms of the Third Party Agreement are more favorable than those set forth in the last proposal of Orion to adjust the Minimum Net Sales during those negotiations. If the Third Party Agreement is more favorable, then Orion shall owe USL fair value for the assignment and grant of license made in accordance with Section 20.3.1 above. Upon USL’ s request, Orion shall (within 30 days) meet with to negotiate in good faith the amount and payment terms to be paid by Orion. If the parties are unable to reach a written agreement within sixty (60) days after the date of USL’ s request, either party may initiate arbitration in accordance with Sections 25.3 and 25.4, and the arbitrators shall have authority to determine the amount to be paid by Orion to USL pursuant to this Section based upon fair value of the assets assigned and license granted taking into account, among other reasonable commercial factors, the amounts incurred or paid by USL in connection with the Regulatory Approvals, and development data, including payments to Orion for milestones hereunder and to reimburse Orion its expenses. In the event of arbitration, the Parties agree that the arbitrators must, and hereby direct the arbitrators to, (1) assign a value ranging from a minimum of [***] to a maximum of [***] of USL’s total investment and out-of-pocket expenses incurred in connection with the Development and Regulatory Approval for the Product in the Territory, including any license fee and milestone payments to Orion, amounts otherwise reimbursed and paid to Orion, and any and all other out of pocket expenses of USL in connection with the Development and Regulatory Approval for the Product in the Territory, and (2) provide for payment of said fair value in three (3) equal installments payable one-third at the time the arbitral award is issued, one-third six (6) months thereafter, and one-third twelve (12) months thereafter.

 

20.4                                           Termination in Case of Lack of Efficacy. USL may terminate the Agreement upon sixty (60) days written notice of termination if any of the clinical studies are not completed successfully (success in the case of each such clinical study being the successful achievement of the study’s protocol criteria). However, if any of the clinical studies are not completed successfully and USL does not give notice of termination of this Agreement prior to filing the Product NDA, USL may not terminate this Agreement under this Section for Product efficacy reasons pursuant to this Section while the Product NDA is filed and pending at the FDA, until an official non-approvable FDA decision has been issued, or the FDA has otherwise officially notified Orion or USL in writing that the Product is considered non-approvable for efficacy reasons.

 

20.5                                           Termination by USL under Section 4.4.3(b).

 

20.5.1                                 USL may terminate this Agreement in accordance with, and subject to, Section 4.4.3(b).

 

20.5.2                                 If USL terminates this Agreement pursuant to Section 20.5.1 Orion may give notice within sixty (60) days following Orion’s receipt of USL’s written notice of termination that Orion desires to obtain an assignment from USL of USL’s right and interest in: (i) all development data and other information arising out of or in connection with the development work conducted in accordance with the Development Plan by or on behalf of USL pursuant to this Agreement; (ii) all submission and materials prepared by or on behalf of USL in connection with Regulatory Approvals sought by USL for the Product, including but not limited to the NDA or any IND, and any applications therefor including without limitation, copies of its correspondence with Regulatory Authorities regarding the same, a copy of all information in its possession or under its control that is contained in its regulatory and/or safety databases relating to the Product,

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

including all materials prepared by USL relating to the Product NDA for the Product for the Territory, all in the format then currently maintained by USL; and (iii) at the request of Orion any ongoing development work in relation to the Product and the management of any studies forming part of the Development Plan being carried out by or on behalf of USL at the date of termination. In addition, USL will grant Orion a royalty-free, nonexclusive license under the USL Patent Rights in the Territory, if any, to the extent they relate specifically to the Product, for the purpose of enabling Orion to make, have mad; use, import, sell, offer to sell and import Product in the Field in the Territory. Moreover, USL shall use commercially reasonable efforts to provide, at Orion’s expense, all cooperation and assistance reasonably requested by Orion to enable Orion (or its nominee) to assume with as little disruption as possible, the Development and commercialization of Product in the Field in the Territory. Such cooperation and assistance shall be provided as promptly as possible (having regard to the nature of the cooperation or assistance requested) and shall include without limitation the following, for a period of eighteen (18) months following termination, USL shall in response to requests from Orion or its nominee, continue to use commercially reasonable efforts to provide such information, advice and assistance relating to the Product as may be reasonably required from time to time. The Parties shall use commercially reasonable efforts to complete the transition of the Development and commercialization of the Product from USL to Orion pursuant to this Section as soon as is reasonably possible.

 

20.5.3                                 USL’s assignment and grant of license in accordance with Section 20.5.2 above, Orion shall owe USL fair value for the assignment and grant of license made in accordance with Section 20.5.2 above. Determination of the amount to be paid by Orion to USL shall not delay USL’s assignment and grant as provided in Section 20.5.2. Upon Orion’s request for an assignment and license under Section 20.5.3, Orion and USL shall (within 30 days) meet with to negotiate in good faith the amount and payment terms to be paid by Orion, it being agreed that the amount to be paid shall (a) not be less than [***] nor more than [***] of USL’s total investment and out-of-pocket expenses incurred in connection with the Development and Regulatory Approval for the Product in the Territory, including any license fee and milestone payments to Orion, amounts otherwise reimbursed and paid to Orion, and any and all other out of pocket expenses of USL in connection with the Development and Regulatory Approval for the Product in the Territory, and (b) shall be payable in three (3) equal installments, one-third at the time the parties reach written agreement as to the amount to be paid, USL’s assignment and license grant under Section 20.5.2, and one-third twelve (12) months after USL’s assignment and license grant under Section 20.5.2. If the parties are unable to reach a written agreement within ninety (90) days after the date of USL’s request, either party may initiate arbitration in accordance Sections 25.3 and 25.4, and the arbitrators shall have authority to determine the amount to be paid by Orion to USL pursuant to this Section based upon fair value of the assets assigned and license granted taking into account, among other reasonable commercial factors, the amounts incurred or paid by USL in connection with the Regulatory Approvals, and development data, including payments to Orion for milestones hereunder and to reimburse Orion its expenses. In the event of arbitration, the Parties agree that the arbitrators must, and hereby direct the arbitrators to, (1) assign a value ranging from a minimum of [***] to a maximum of [***] of USL’s total investment and out-of-pocket expenses incurred in connection with the Development and Regulatory Approval for the Product in the Territory, including any license fee and milestone payments to Orion, amounts otherwise reimbursed and paid to Orion, and any and all other out of pocket expenses of USL in connection with the Development and Regulatory Approval for the Product in the Territory, and (2) provide for payment of said fair value in three (3) equal installments payable one-third at the time the arbitral award is issued, one-third six (6) months after USL’s assignment and license grant under Section 20.5.2, and one-third twelve (12) months after USL’s assignment and license grant under Section 20.5.2.

 

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20.6                                           Termination by Either Party Upon Safety Concerns, or FDA Ordered Discontinuance. Either Party may terminate this Agreement effective upon thirty (30) days written notice of termination to the other upon the occurrence of any of the following events:

 

(i)                                     Prior to the filing of the Product NDA, the FDA requires that Development of the Product be discontinued; or

 

(ii)                                  Safety considerations arise or become known, which are of such nature as to make it unsafe, or commercially unreasonable due to safety concerns, to market and sell the Product in the Field in the Territory.

 

Prior to such election, the Parties shall review such situation and intended decision and give good faith consideration to the other Party’s views regarding the seriousness of such safety issue. If a party has not given notice of termination of this Agreement before the product NDA is filed, neither Party may give notice of termination of this Agreement for Product safety reasons pursuant to this Section while the Product NDA is filed and pending at the FDA, until an official non¬approvable FDA decision has been issued, or the FDA has otherwise officially notified Orion or USL in writing that the Product is considered non-approvable for safety reasons. The non-terminating Party may elect (by written notice to the terminating Party given within sixty (60) days of the terminating Party’s notice of termination under this Section 20.6), in the case of Orion, to obtain the rights specified in Section 20.2.3 on the terms stated in that Section, and in the case of USL, to obtain the rights specified in Section 20.2.2 on the terms stated in that Section.

 

20.7                                           Post-Termination Continued Purchase and Supply under Current Purchase Orders; Continued Sale of Product in the Territory and Disposal of Inventory.

 

20.7.1                                 Upon termination of this Agreement for any reason, other than by Orion under Section 20.2 (due to USL’s uncured material breach) or under Section 20.6: (a) USL shall, for a period of twelve months (12) months following .USL’s last receipt of Product by USL in accordance with 20.7.3 (or if USL is manufacturing Product, upon USL’s last production of Product utilizing raw materials ordered in the ordinary course prior to termination), be free to sell its remaining and then existing inventory as of the termination date, as well as Product purchased pursuant to Section 20.7.3, and (b) Orion shall continue, at USL’s request, to supply USL Product under purchase orders submitted through the termination date of this Agreement, all in accordance with the terms of this Agreement.

 

20.7.2                                 Upon termination of this Agreement by Orion under Section 20.2 (due to USL’s uncured material breach) USL shall dispose of its inventory of Product, at its expense.

 

20.7.3                                 Upon termination of this Agreement, other than by USL under Section 20.2 (due to Orion’s uncured material breach) or under Section 20.6, USL shall purchase from Orion, and Orion shall supply to USL, all Product subject to the then current Purchase Orders.

 

20.7.4                                 Upon termination of this Agreement by USL under Section 20.2 (due to Orion’s uncured material breach), upon USL’s request, Orion shall repurchase any remaining inventory of Product under USL’s ownership and control, at the supply price originally paid by USL to Orion for same. Orion will pay for such Product within a forty-five (45) day period after receiving USL’s request, and USL shall deliver such repurchased quantity of Product to Orion or its designee within forty-five (45) after receiving such payment.

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

20.8                                           Certain Rights and Obligations Upon Termination. Neither termination of this Agreement under Section 20, nor expiration of the Term, shall relieve either party of obligations under this Agreement or for liability for any breach of this Agreement incurred prior to or in connection with its termination or expiration. Any liability for either Party to the other Party for any post termination compensation for consequential damages, including without limitation, loss of business, sales, or profits, resulting from or incident to such termination, shall be subject to the limitation on consequential damages set forth in Section 16.13. Rights and remedies specified in Section 20 upon termination by either Party due to the other Party’s uncured material breach shall be in addition to any and all other rights and remedies available in the event of breach under this Agreement or applicable law. The provisions of Sections 6.10, 6.11, 6.12, 12.5, 13.4, 13.5, 14.3, 14.6, 16.2, 16.10, 16.11, 16.12, 16.13, 16.14, 16.15, 17, 20, and 25; and any other provision which by its terms is intended to survive the termination of this Agreement will survive the termination or expiration or non-renewal of this Agreement and remain in full force and effect thereafter in accordance with their terms.

 

20.9                                           License Upon Expiration of Term or Certain Events of Termination. Upon expiration of the Term, or upon termination of this Agreement by USL under Section 20.1 (due to Orion’s insolvency) or under Section 20.2 (due to Orion’s uncured material breach), USL shall have an irrevocable, license under the Orion Patent Rights (if any) and Orion Proprietary Information existing as of the date of the expiration of the Agreement (excluding, however, the right to utilize Orion’s manufacturing identifier code in connection with Product acquired by USL from manufacturer(s) other than Orion) to develop, make, have made, use, sell, offer to sell and import such Product. Such license shall be non-exclusive in the event of expiration of the Term, but shall be exclusive in the event of termination by USL under Section 20.1 (due to Orion’s insolvency) or under Section 20.2 (due to Orion’s uncured material breach). USL shall pay royalties in accordance with Section 13.4 in the event of expiration of the Term, but shall have no obligation for payment of any royalty under Section 13.4 or otherwise in the event termination by USL under Section 20.1 (due to Orion’s insolvency) or under Section 20.2 (due to Orion’s uncured material breach). Orion shall furnish all technical assistance reasonably requested, and do such other things as contemplated in this Agreement upon USL’s commencing manufacture, to enable USL promptly and with as little interruption as possible conclude Development, obtain and maintain Regulatory Approval, and to manufacture or have manufactured its requirements for the Product for the Territory. Without limitation, Orion shall use commercially reasonable efforts to provide, at USL’ s expense, all cooperation and assistance reasonably requested by USL to enable USL (or its nominee) to assume with as little disruption as possible, the Development and manufacture of Product in the Field in the Territory. Such cooperation and assistance shall be provided as promptly as possible (having regard to the nature of the cooperation or assistance requested) and shall include without limitation the following, for a period of eighteen (18) months following termination, Orion shall in response to requests from USL or its nominee, continue to use commercially reasonable efforts to provide such information, advice and assistance relating to the Product as may be reasonably required from time to time.

 

The Parties shall use commercially reasonable efforts to complete the transition of the Development and manufacture of the Product from Orion to USL pursuant to this Section 20.9.

 

20.10                                    Upon any termination of this Agreement, USL and its Affiliates shall thereafter not, except as contemplated in Section 6.18 and Section 20.7.1, hold themselves out as Orion’s distributor of Product in the Territory.

 

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21                                                     21 NOTICES

 

21.1                                           Any notice or other communication hereunder shall be in writing and shall be deemed given when so delivered in person, by overnight courier (with receipt confirmed), by facsimile transmission (with receipt confirmed by telephone or by automatic transmission report) or upon receipt if sent by certified mail, return receipt requested, as follows (or to such other persons and/or addresses as may be specified in writing to the other party hereto):

 

21.2                                           Notices to Orion shall be to:

 

Orion Corporation Orion Pharma
 Orionintie 1 (P.O. Box 65) FIN-02200 ESPOO,
 Finland

 

Facsimile No. +358-10-429 3815

 

Attention: President with a separate copy to Vice President Legal Affairs at same address.

 

Notices to USL shall be to:

 

Upsher-Smith Laboratories, Inc.
 6701 Evenstad Drive
 Maple Grove, MN United States 55369

 

Facsimile: (763) 315-2370

 

Attention: President and Chief Operating Officer

 

With a separate copy to:

 

Attention: Vice President, Legal Affairs, at the same address
 Facsimile: (763) 258-5578

 

22                                                     INTEGRATION CLAUSE

 

22.1                                           This Agreement, together with the attached Schedules, represents the entire agreement between the Parties relating to the subject matter hereof and supersedes all prior arrangements, understandings, correspondence, notes, minutes and agreements between the Parties with respect to the subject matter of this Agreement, whether written or oral. In case of an inconsistency between this Agreement and its Schedule(s) this Agreement shall take precedence over its Schedule(s).

 

No supplement, modification or amendment of this Agreement shall be binding unless executed by the Parties in writing and signed by the duly authorized representatives of both Parties hereto.

 

23                                                     COUNTERPARTS

 

23.1                                           No waiver of any of the provisions of this Agreement shall be deemed binding unless executed in writing by the Party to be bound by it.

 

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23.2                                           This Agreement is executed in duplicate originals, one being retained by each Party and either original of which shall be deemed sufficient to evidence the existence of and terms of this Agreement.

 

24                                                     ASSIGNMENT

 

24.1                                           This Agreement is deemed personal to USL and Orion. Therefore, neither Party shall, without the prior written consent of the other, assign this Agreement or any of its rights hereunder, nor delegate any of its duties or obligations hereunder without the prior written consent of the other, except as expressly provided for otherwise by this Agreement.

 

24.2                                           Notwithstanding the foregoing, a Party may assign this Agreement to an Affiliate; provided, however, the assigning Party shall remain liable for the performance of its Affiliate under the terms of this Agreement. Furthermore, either Party shall be entitled to assign this Agreement (a) in connection with a merger, consolidation or sale of substantially all of such Party’s business or assets that are the subject of this Agreement to an unrelated Third Party of good financial standing; provided, however, that such Party’s rights and obligations under this Agreement shall be assumed by its successor in interest in any such transaction and shall not be transferred separate from all or substantially all of its other business assets that are the subject of this Agreement, or (b) if a Party or its Affiliates is required to divest Product or a competing product in order to comply with applicable laws or regulations or any governmental agency or authority as a result of merger or acquisition; provided, however, that (1) the assignee shall be of good financial standing and the assigning Party has given the other Party at least thirty (30) days prior written notice or the proposed assignment, accompanied by information as may reasonably permit the other Party to evaluate the financial standing of the proposed assignee (it being understood that if the other party gives written notice reasonably requesting additional information regarding the proposed assignee’s financial standing or otherwise gives written notice reasonably objecting to the financial standing of the proposed assignee, the assignment shall not occur unless either (i) the other Party consents to such assignment, which consent shall not be unreasonably withheld, or (ii) the assigning Party agrees that the assignment shall not release the assigning party from its duties and obligations under this Agreement) and (2) the non-assigning Party receives reasonable written assurances from the assignee of its adherence to its obligations under this Agreement. Any assignment or delegation in derogation of this provision shall be deemed null and void. Any assignment to an Affiliate shall not release the original party hereto from its duties and obligations under this Agreement.

 

25                                                     GOVERNING LAW AND DISPUTE RESOLUTION

 

25.1                                           Governing Law. This Agreement is acknowledged to have been made in and shall be construed, governed, interpreted and applied in accordance with the laws of [***] without giving effect to its conflict of laws provisions.

 

25.2                                           Efforts to Resolve Disputes. In the event of any controversy or claim arising out of, relating to or in connection with any provision of this Agreement, or the rights or obligations of the Parties hereunder, the Parties shall try to settle their differences amicably between themselves. Either Party may initiate such informal dispute resolution by sending written notice of the dispute to the other Party, and within thirty (30) business days after such notice appropriate representatives of the Parties shall meet for attempted resolution by good faith negotiations. If such representatives are unable to resolve promptly such disputed matter within the said thirty (30) business days, either party may refer the matter by written notice to the other to the President of Orion Pharma for Orion and either the Vice Chairman or Chief Operating Officer of USL (or

 

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their designees) for discussion and resolution. If such Officers are unable to resolve such dispute within thirty (30) Business Days of such written notice, either Party may initiate arbitration proceedings in accordance with the provisions of Section 25.4.

 

25.3                                           Arbitration. Should the Parties fail to settle any controversy, claim, or dispute arising out of or relating to any provision of this Agreement after following the procedures set forth in Section 25.2, then the matter in dispute shall be finally and exclusively settled by binding international arbitration.

 

25.4                                           Conduct of Arbitration.

 

(a)                                 The Parties hereto hereby agree that all disputes arising out of or in connection with this Agreement shall be finally and exclusively settled by arbitration by a panel of three (3) arbitrators. The arbitrators must be knowledgeable or experienced in the pharmaceutical industry. The arbitration proceeding shall be conducted under the Rules of Arbitration and Conciliation of the International Chamber of Commerce with such proceedings to be held in [***] in English language. Judgment upon the award rendered by arbitration may be issued and enforced by any court having competent jurisdiction.

 

(b)                                 If a Party intends to begin an arbitration to resolve a dispute, such Party shall provide written notice to the other Party, informing the other Party of such intention and the issues to be resolved. Within twenty (20) business days after its receipt of such notice, the other Party shall, by written notice to the Party initiating arbitration, add any additional issues to be resolved which would be considered mandatory counterclaims under [***] law. For clarity, the resolution of any disputes regarding such counterclaims shall be conducted in the same proceedings as the initial claims, and the applicable law governing any such disputes shall be the same law that is applicable to the initial claims made by the other Party.

 

(c)                                  Within forty-five (45) days following the receipt of the notice of arbitration, the Party referring the matter to arbitration shall appoint an arbitrator and promptly notifying the other Party of such appointment. The other Party shall, upon receiving such notice, appoint a second arbitrator within twenty one (21) days, and the two (2) arbitrators shall, within fifteen (15) days of the appointment of the second arbitrator, agree on the appointment of a third arbitrator who will act with them and be chairperson of the arbitration panel. In the event that either Party shall fail to appoint an arbitrator within thirty (30) days after the commencement of the arbitration proceeding, the arbitrator shall be appointed by the International Chamber of Commerce. In the event of the failure of the two (2) arbitrators to agree within sixty (60) days after the commencement of the arbitration proceeding to appoint the chairperson, the chairperson shall also be appointed by the International Chamber of Commerce. The arbitrators shall not be employees, directors or shareholders of either Party or any of their Affiliates.

 

(d)                                 Each Party shall have the right to be represented by counsel.

 

(e)                                  To the extent possible, the arbitration hearings and award will be maintained in confidence.

 

(f)                                   In any arbitration pursuant to this Agreement, the award or decision shall be rendered by a majority of the members of the panel provided for herein, with each member having one (1) vote. The arbitrators shall render a written decision with their resolution of the

 

54

 

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dispute. The decision of the arbitrators shall be final and non-appealable and binding on the Parties. Any determination as to the arbitrability of an issue or dispute shall be made by the arbitrators.

 

(g)                                  Each party has the right before or during the arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, preliminary injunction, replevin, etc. to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration.

 

25.5                                           It is the specific intent and agreement of the Parties that the United Nations Convention on the International Sale of Goods shall not apply to this Agreement.

 

26                                                     TERM OF AGREEMENT

 

26.1                                           This Agreement shall become effective as of the Date of Agreement and, unless earlier terminated in accordance with the provisions of Section 20 or another provision of this Agreement, shall remain in effect for the Term. Following the expiration of such period, the Parties may agree to extend this Agreement for the Product upon mutual written agreement. Absent extension or renewal of the Term, after the expiration of the Term, the Parties shall have such rights and obligations under this Agreement as are described in this Agreement

 

26.2                                           This Agreement may also be earlier terminated or modified according to other provisions as set out herein.

 

27                                                     INDEPENDENT CONTRACTOR STATUS OF PARTIES

 

The status of Orion and USL under the business arrangement established by this Agreement is that of independent contractors. It is expressly agreed that for tax, legal or other purposes (i) this Agreement or any portion of this Agreement shall not be considered to be a partnership agreement, and (ii) the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Party has any authority whatsoever to act as an agent or representative of the other, nor has either any authority or power to contract for, or create or assume any obligation or liability in the other’s name or on behalf of the other or otherwise bind the other in any way for any purpose, nor shall either Party hereto represent to any Third Parties it possesses any such authority to bind the other Party. USL shall purchase the Product from Orion for resale to USL’s customers in USL’s own name and for USL’s own account.

 

28                                                     REPRESENTATIONS AND WARRANTIES - GENERAL

 

28.1                                           Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party as follows:

 

(a)                                 It is a corporation duly organized and validly existing under the laws of the state or other jurisdiction of incorporation or formation;

 

(b)                                 It has the power and authority to execute and deliver this Agreement, and to perform its obligations hereunder;

 

(c)                                  Except for regulatory filings and approvals for the Product referenced herein, no authorization, consent or approval of any governmental authority or Third Party is required for the execution, delivery and performance by it of this Agreement, and the

 

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execution, delivery and performance of this Agreement will not violate any Jaw, rule or regulation applicable to such Party.

 

(d)                                 There is no claim, investigation, suit, action or proceeding pending or, to the knowledge of such Party’s management, expressly threatened, against such Party before or by any Third Party governmental entity or arbitrator that, individually or in the aggregate, could reasonably be expected to (i) materially impair the ability of such Party to perform any obligation under this Agreement, or (ii) prevent or materially delay or alter the consummation of any or all of the transactions contemplated hereby.

 

(e)                                  Notwithstanding anything to the contrary in this Agreement, the execution and delivery of this Agreement and the performance of such Party’s obligations hereunder (i) do not conflict with or violate such Party’s corporate charter and bylaws or any requirement of applicable laws of regulations, and (ii) do not and shall not conflict with, violate or breach or constitute a default or require any consent under, any contractual obligation of such Party.

 

28.2                                           Additional Representations and Warranties of Orion. Orion represents and warrants to USL as follows:

 

(a)                                 It owns and/or Controls the Orion Proprietary Information existing at the Date of Agreement and has the rights and authority to grant the rights and licenses under Orion Proprietary Information to USL. No third party has been granted any rights or license (including any lien or security interest in any Orion Proprietary Information or Orion Patent Rights in the Territory).

 

(b)                                 To the best of its management’s knowledge (after diligent inquiry) as of the Date of Agreement: (1) Orion is not aware of any existing valid Third Party Patent Rights in the Territory that might be infringed by the manufacture, import, marketing, sale or use of Product or Compound in accordance with this Agreement; however, Orion makes no warranty or representation that such Third Party Patent Rights might not in fact prove to exist in the Territory; (2) no claim has been made against it challenging its right to use or ownership of any of the Orion Proprietary Information or making any adverse claim of ownership thereof; and (3) the inception, development, and reduction to practice of the Orion Proprietary Information has not constituted or involved, the misappropriation of trade secrets, or infringement of any other intellectual property rights, of any third party. Nothing in this Section 28.2(b) is intended to, nor shall it, limit Orion’s obligations and liability and this Agreement in the event the Product infringes Third Party Patent Rights.

 

(c)                                  To the best of its management’s knowledge after diligent inquiry, Orion has disclosed to USL all material information available and known to Orion and/or its Affiliates with respect to the safety or efficacy of the Compound and any human risk factors related thereto, as well as to the extent free to be disclosed by Orion all material pre-clinical and non-clinical data relating to the Compound. Without limitation, Orion has no knowledge of any adverse test results regarding the Product indicating that the Product is unsuitable or unsafe for the purposes contemplated by this Agreement;

 

(d)                                 To the best of its management’s knowledge after reasonable inquiry Orion has not received any notification of, and has no knowledge that there is now pending or that

 

56

 

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there have been any U.S. governmental regulatory orders to restrict or limit the use of the Product in the Territory.

 

(e)                                  To the best of Orion’s management’s knowledge, no Third Party is using the Orion Proprietary Information in the Territory.

 

(f)                                   To the best of Orion’s management’s knowledge, no part of Orion’s Proprietary Information has been disclosed except in patent applications filed prior to public disclosure, in submissions to regulatory authorities or pursuant to suitable confidentiality agreements.

 

28.3                                           Additional Representations and Warranties of USL. USL represents and warrants to Orion as follows:

 

(a)                                 USL has disclosed to Orion all material information available and known to USL and/or its Affiliates with respect to the safety or efficacy of the Compound and any human risk factors related thereto, as well as all material pre-clinical and non-clinical data relating to the Compound.

 

29                                                     LANGUAGE

 

The meaning of all words and phrases in this Agreement shall be defined, construed and interpreted in English, and the Parties acknowledge that the terms and provisions of this Agreement, as stated in English, accurately reflect their intent and understanding. USL shall not be responsible in any manner for any interpretation or translation of this Agreement that Orion may obtain.

 

30                                                     NON-WAIVER CLAUSE

 

No waiver by either Party of any nonperformance or violation by the other Party of any of the covenants, obligations or agreements of such other Party hereunder shall be deemed to be a waiver of any subsequent violation or non-performance of the same or any other covenant, agreement or obligation, nor shall forbearance by either Party be deemed to be a waiver by such Party of its rights or remedies with respect to such violation or nonperformance.

 

31                                                     HEADINGS

 

The headings in this Agreement are inserted for the convenience of the Parties only and may not be used in the interpretation of any provisions hereof.

 

32                                                     PUBLICITY

 

Unless agreed upon in writing beforehand by the Parties, neither Party shall discuss with Third Parties or originate any publicity, news release or other public announcement, written or oral, whether to the public press, stockholders or otherwise, regarding any matters relating to the content or terms of this Agreement, or any amendment hereto, or the performance by either of the Parties hereunder, except for such announcement as in the opinion of legal counsel to the Party making such announcement is required under applicable law or stock exchange regulations, in which event such Party shall give the other Party an opportunity reasonable under the circumstances (i.e. and save as for applicable legal, regulatory or stock exchange

 

57

 

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requirements requiring a shorter period, a period of no less than fourteen (14) days) to review the form and content of the announcement before such legally required disclosure is made.

 

The Parties acknowledge their mutual desire to issue a public announcement concerning the execution of this Agreement generally describing the nature of the Agreement, the extent of the rights granted to USL. The Parties shall mutually agree in writing on the contents and timing of such announcement(s) prior to their issuance.

 

33                                                     NO THIRD PARTY BENEFICIARIES

 

No person or entity other than USL, Orion and their respective Affiliates and permitted assignees hereunder shall be deemed an intended beneficiary hereunder or have any right to enforce any obligation of this Agreement.

 

IN WITNESS WHEREOF, the Parties’ duly authorized representatives hereto have executed this Agreement as of the day and year first above written.

 

SIGNATURES

 

	
Signed
    	
 
    	
Signed
    
	
ORION   CORPORATION
   ORION PHARMACEUTICALS
    	
 
    	
UPSHER-SMITH
   LABORATORIES, INC.
    
	
 
    	
 
    	
 
    
	
By
    	
 
    	
By
    
	
 
    	
 
    	
 
    
	
/s/   Risto Hämäläinen
    	
/s/   Timo Lappalainen
    	
 
    	
/s/   Mark Evenstad
    
	
Signature
    	
Signature
    	
 
    	
Signature
    
	
 
    	
 
    	
 
    
	
Risto   Hämäläinen
    	
Timo   Lappalainen
    	
 
    	
Mark   Evenstad
    
	
Name
    	
Name
    	
 
    	
Name
    
	
 
    	
 
    	
 
    
	
President
    	
Senior   Vice President
    	
 
    	
Vice   Chairman and President
    
	
Title
    	
Title
    	
 
    	
Title
    
	
(Authorized   Officer)
    	
(Authorized   Officer)
    	
 
    	
(Authorized   Officer)
    

 

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SCHEDULE 1

 

Orion Patents

 

US Application 60/498,611 titled “Transderrnal Compositions” (Kiesvaara et al.); filing date 29 August, 2003

 

59

 

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SCHEDULE 2

 

Initial Development Plan

 

The Initial Development Plan is attached in its entirety after Schedule 5.

 

60

 

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SCHEDULE 3

 

Initial Specifications for Product

 

	
Item
    	
 
    	
Method
   reference
    	
 
    	
At release
    	
 
    	
During stability
    
	
Appearance   of content
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Appearance   of dose package
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Average   mass:
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
0.25g   dose package
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
[***]
    
	
0.5g dose   package
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
[***]
    
	
1.0 g dose-package
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Minimum   fill
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
—
    
	
Content   uniformity
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
—
    
	
pH
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Viscosity
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Identification,   HPLC
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
—
    
	
Identification,   TLC
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
—
    
	
Assay
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
In-vitro   Release Test
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Related   substances:
    	
 
    	
[***]
    	
 
    	
 
    	
 
    	
 
    
	
Specified   Identified
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Specified   Unidentified
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Any   Unspecified
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Total
    	
 
    	
 
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Ethanol   content
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Total   viable aerobic count
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Enterobacteria   and other gram-negative bacteria
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Staphylococcus   aureus
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Pseudomonas   aeruginosa
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

Microbiological requirements tested as per FDA requirements

Eventual skip testing to be applied only after FDA approval

 

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Specifications for the Drug Substance **

 

	
Item
    	
 
    	
Method Reference
    	
 
    	
for DS from Schering
    	
 
    	
for DS from Dlosynth
    	
 
    	
Comments
    
	
Appearance
    	
 
    	
[***]
    	
 
    	
—
    	
 
    	
—
    	
 
    	
 
    
	
Identification A
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Identification B
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Melling Range
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Specific Rotation
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Water
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Assay
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Related Substances
    	
 
    	
[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    
	
Specified Identified:
    	
 
    	
[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    
	
17alpha-estradiol
    	
 
    	
[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    
	
Estrone
    	
 
    	
[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    
	
4-mehtyl   estradiol
    	
 
    	
[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    
	
6-keto   estradiol
    	
 
    	
[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    
	
delta   9(11) estradiol
    	
 
    	
[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    
	
other   named peaks
    	
 
    	
[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    
	
Specified   Unidentified:

list each separately by retention   time relative to estradiol
    	
 
    	
[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    
	
Any unspecified
    	
 
    	
[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    
	
Total
    	
 
    	
[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    
	
Residual solvents (ethanol)
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
OVI
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

Based on due diligence discussions between USL and Orion, Orion will replace the current, single incoming drug substance specification with separate specifications for the two suppliers. Orion specification will reflect tests and limits as presented by each supplier on their respective Certificate of Analysis.

 

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SCHEDULE 4

 

Manufacturing Cost Principles

 

DEFINITION OF FULLY ABSORBED MANUFACTURING COST (“FAMC”)

 

I.                                  FAMC includes the costs of all direct material, direct labor and manufacturing overhead consumed, provided or procured by a manufacturing facility in the manufacture of Product.

 

A.                                    Direct Material costs include:

 

1.                                      The cost of raw materials, process consumables (i.e., resins, membranes, etc.), containers, container components, packaging, labels and other printed materials used in production.

 

2.                                      Scrap of raw materials, work in progress and finished goods (excluding losses in excess of a reasonable allowance for normal wastage limits, and also excluding losses due to failure of Product to meet specifications).

 

B.                                    Direct Labor costs include:

 

1.                                      Salaries and fringe and other benefits and employer’s contributions for personnel directly involved in the manufacturing process. (engineering & development moved to overhead section)

 

C.                                    Direct Service costs include:

 

Costs of services provided by third parties for the manufacture of Product or any component thereof (e.g., sterilization and specialized testing, manufacturing of raw materials).

 

D.                                    Manufacturing Overhead includes all direct and indirect manufacturing costs that cannot be identified in a practical manner with specific units of production and, therefore, cannot be included in specific FAMC as direct material or direct labor. Such overhead costs include:

 

1.                                      Department specific manufacturing overhead allocations, including, but not limited to, utilities (e.g., oil, electric, steam, water), indirect manufacturing materials and supplies, consumables (e.g., production supply materials, tools, spare parts), supervision, production management, plant management and support, engineering and development support, maintenance and repair of the production plant and production equipment, taxes (excluding income taxes) and insurance.

 

2.                                      Depreciation, which reflects on a pro rata basis, the use of assets used for manufacturing the Product, including depreciation on investments in new equipment required for production of the Product under this Agreement.

 

3.                                      Overhead allocations from involved service areas, including human resources, IT, quality assurance analysis of raw materials in production including analysis of semi-finished and finished goods produced, materials management (including wages and salaries relating to materials administration, purchasing and

 

63

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

warehousing), regulatory affairs, validation, outside services (security, laundry, testing, etc.), cost accounting, inventory storage related to raw materials and semi-finished goods, process documentation, and other services required to be performed in connection with the manufacturing of the Product.

 

4.                                      Overhead allocations for general services used at the production facility including telephones and fax, library, postal services (internal and external), copying and office services/equipment, cleaning, health services, energy maintenance, security, and cafeterias.

 

5.                                      Freight, warehousing costs, taxes and import duties, and forwarding costs on raw materials payable by Orion.

 

6.                                      Rent and other costs allocable to the lease of facilities, equipment or materials used to manufacture the Product.

 

7.                                      Actual cost incurred for engineering services, permitting, equipment or otherwise in connection with compliance with environmental laws (including waste disposal) as a result of the manufacture of the Product.

 

II.                             FAMC does not include:

 

A.                                    Plant costs incurred due to product rework, except the reasonable allowance included under item A.2.

 

B.                                    The value of product discarded in the manufacturing operation (other than process related scrap as stated above).

 

C.                                    Allocations of (i) overhead incurred outside of the manufacturing plant such as support, business development, accounting, taxes and legal, and (ii) overhead for any portion of Orion’s production facility not fully utilized for production in Orion’s customary manner.

 

D.                                    Freight, property and sales taxes on finished good shipment and warehousing related to finished goods.

 

E.                                     Inventory carrying costs

 

F.                                      Development Costs or other research and development costs.

 

G.                                    Costs associated with the change of site of manufacture and the change of container, including without limitation the costs of satisfying all registration and other requirements of Regulatory Authorities.

 

H.                                   Any intercompany margins/markups on intercompany transfers between or among manufacturing plants or any of its affiliates.

 

I.                                        Insurance related to product liability.

 

J.                                        Costs related to pharmaceutical development, manufacturing process development or validation, or process scale-up

 

K.                                    General and administrative expenses.

 

64

 

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III.                        FAMC will be calculated in accordance with generally accepted accounting principles (GAAP) applied on a consistent basis in the country of manufacture. The procedures shall ensure that Product are allocated a fair and reasonable portion of costs on a basis that is consistent with all products produced or to be produced at the manufacturing facility. The “cost” for purchased materials or services will include the actual amount paid including the benefit of any price reductions, payment or terms discounts, or other reimbursements, such as volume discounts, that may be applicable to such purchases.

 

65

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

SCHEDULE 5

 

Pharmacovigilance

 

66

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
1
    	
 
    	
 
    	
 
    	
Divigel Development
    	
 
    	
843 days
    	
 
    	
10/13/03
    	
 
    	
1/16/07
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
2
    	
 
    	
 
    	
 
    	
Project   Initiation
    	
 
    	
15 days
    	
 
    	
11/3/03
    	
 
    	
11/21/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
3
    	
 
    	
ü
    	
 
    	
Start   Project
    	
 
    	
0 days
    	
 
    	
11/3/03
    	
 
    	
11/3/03
    	
 
    	
100
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
4
    	
 
    	

    	
 
    	
Identify   USL Team
    	
 
    	
2 wks
    	
 
    	
11/3/03
    	
 
    	
11/14/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
5
    	
 
    	

    	
 
    	
Identify   Orion Team
    	
 
    	
2 wks
    	
 
    	
11/3/03
    	
 
    	
11/14/03
    	
 
    	
0
    	
%
    	
4FF
    	
 
    	
Orion
    	
 
    
	
6
    	
 
    	

    	
 
    	
Identify   Steering Committee
    	
 
    	
3 wks
    	
 
    	
11/3/03
    	
 
    	
11/21/03
    	
 
    	
0
    	
%
    	
4SS
    	
 
    	
USL,Orion
    	
 
    
	
7
    	
 
    	

    	
 
    	
Create   Project Tracking Tools
    	
 
    	
3 wks
    	
 
    	
11/3/03
    	
 
    	
11/21/03
    	
 
    	
0
    	
%
    	
4SS
    	
 
    	
USL,Orion
    	
 
    
	
8
    	
 
    	

    	
 
    	
Establish   Project Update Schedule
    	
 
    	
3 wks
    	
 
    	
11/3/03
    	
 
    	
11/21/03
    	
 
    	
0
    	
%
    	
4SS
    	
 
    	
USL,Orion
    	
 
    
	
9
    	
 
    	
 
    	
 
    	
IND   Preparation and Review
    	
 
    	
125 days
    	
 
    	
11/10/03
    	
 
    	
5/13/04
    	
 
    	
0
    	
%
    	
3FS+5 days
    	
 
    	
 
    	
 
    
	
10
    	
 
    	
 
    	
 
    	
CMC   Tasks
    	
 
    	
75 days
    	
 
    	
11/10/03
    	
 
    	
3/4/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
11
    	
 
    	
 
    	
 
    	
API   Drug Substance
    	
 
    	
45 days
    	
 
    	
11/10/03
    	
 
    	
1/22/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
12
    	
 
    	
 
    	
 
    	
Specification   and method development
    	
 
    	
6 wks
    	
 
    	
11/10/03
    	
 
    	
12/19/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
13
    	
 
    	
 
    	
 
    	
Write   report of justification of DS specifications
    	
 
    	
6 wks
    	
 
    	
11/10/03
    	
 
    	
12/19/03
    	
 
    	
0
    	
%
    	
12FF
    	
 
    	
Orion
    	
 
    
	
14
    	
 
    	

    	
 
    	
Provide   confirmation that full USP testing will be done for each lot of estradiol   drug substance used in drug product for manufacture and include HPLC potency   and appropriate impurity assays
    	
 
    	
6 wks
    	
 
    	
11/17/03
    	
 
    	
1/8/04
    	
 
    	
0
    	
%
    	
12FF
    	
 
    	
Orion
    	
 
    
	
15
    	
 
    	

    	
 
    	
File   specifications for each DS supplier
    	
 
    	
40 days
    	
 
    	
11/17/03
    	
 
    	
1/22/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
16
    	
 
    	
 
    	
 
    	
Review of Orion raw data   (chromatograms) for impurity levels present in DS - compile data including 2 batches per year from both suppliers   since product launch in Europe
    	
 
    	
8 wks
    	
 
    	
11/17/03
    	
 
    	
1/22/04
    	
 
    	
0
    	
%
    	
14SS
    	
 
    	
Orion
    	
 
    
	
17
    	
 
    	

    	
 
    	
Provide the   potential synthesis impurities for API. Provide the degradation   pathway(s) for API including name/chemical structures for potential   degradants
    	
 
    	
6 wks
    	
 
    	
11/17/03
    	
 
    	
1/8/04
    	
 
    	
0
    	
%
    	
14FF
    	
 
    	
Orion
    	
 
    
	
18
    	
 
    	
 
    	
 
    	
DS - Identify   impurities, if needed
    	
 
    	
40 days
    	
 
    	
11/10/03
    	
 
    	
1/15/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion Lead/USL Support
    	
 
    
	
19
    	
 
    	
 
    	
 
    	
Identify unknown   impurities > 0.1%
    	
 
    	
4 wks
    	
 
    	
11/10/03
    	
 
    	
12/5/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion Lead/USL Support
    	
 
    
	
20
    	
 
    	
 
    	
 
    	
Write identification   report, if needed, and provide name/chemical structure for each impurity   >0.1%
    	
 
    	
2 wks
    	
 
    	
12/8/03
    	
 
    	
12/19/03
    	
 
    	
0
    	
%
    	
19
    	
 
    	
Orion Lead/USL Support
    	
 
    
	
21
    	
 
    	
 
    	
 
    	
Review and approve   identification report
    	
 
    	
2 wks
    	
 
    	
12/29/03
    	
 
    	
1/15/04
    	
 
    	
0
    	
%
    	
20
    	
 
    	
Orion Lead/USL Support
    	
 
    
	
22
    	
 
    	
 
    	
 
    	
Batch Analysis
    	
 
    	
40 days
    	
 
    	
11/17/03
    	
 
    	
1/22/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
23
    	
 
    	
 
    	
 
    	
Tabulate release data   from tox, stability, and clinical batches using US guidelines
    	
 
    	
40 days
    	
 
    	
11/17/03
    	
 
    	
1/22/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
24
    	
 
    	

    	
 
    	
Provide   list of relevant batches
    	
 
    	
8 wks
    	
 
    	
11/17/03
    	
 
    	
1/22/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
25
    	
 
    	
 
    	
 
    	
Method   Numbers
    	
 
    	
8 wks
    	
 
    	
11/17/03
    	
 
    	
1/22/04
    	
 
    	
0
    	
%
    	
24FF
    	
 
    	
Orion
    	
 
    
	
26
    	
 
    	
 
    	
 
    	
Specification   limits
    	
 
    	
8 wks
    	
 
    	
11/17/03
    	
 
    	
1/22/04
    	
 
    	
0
    	
%
    	
25FF
    	
 
    	
Orion
    	
 
    
	
27
    	
 
    	
 
    	
 
    	
Date(s))   assayed
    	
 
    	
8 wks
    	
 
    	
11/17/03
    	
 
    	
1/22/04
    	
 
    	
0
    	
%
    	
25FF
    	
 
    	
Orion
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

67

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
28
    	
 
    	

    	
 
    	
List   location where DS lots were used. For a given lot of DP which lots of DS were   used. (reference to DP lots made from DS batches.)
    	
 
    	
8 wks
    	
 
    	
11/17/03
    	
 
    	
1/22/04
    	
 
    	
0
    	
%
    	
27SF
    	
 
    	
Orion
    	
 
    
	
29
    	
 
    	
 
    	
 
    	
Methods
    	
 
    	
70 days
    	
 
    	
11/10/03
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
30
    	
 
    	
 
    	
 
    	
Provide   specification and methods that are ready to use
    	
 
    	
4 wks
    	
 
    	
12/29/03
    	
 
    	
1/29/04
    	
 
    	
0
    	
%
    	
12
    	
 
    	
Orion
    	
 
    
	
31
    	
 
    	
 
    	
 
    	
Impurity/Degradation   Method
    	
 
    	
55 days
    	
 
    	
12/1/03
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
32
    	
 
    	

    	
 
    	
Evaluate   USP method for impurities/degradants if not supplied by vendor
    	
 
    	
4 wks
    	
 
    	
1/23/04
    	
 
    	
2/19/04
    	
 
    	
0
    	
%
    	
33
    	
 
    	
Orion
    	
 
    
	
33
    	
 
    	

    	
 
    	
DS   Stress study to identify degradants to show what impurites are in API
    	
 
    	
6 wks
    	
 
    	
12/1/03
    	
 
    	
1/22/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
34
    	
 
    	
 
    	
 
    	
Validate   method for impurities/degradants if not supplied by vendor
    	
 
    	
1 wk
    	
 
    	
2/20/04
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
32
    	
 
    	
Orion
    	
 
    
	
35
    	
 
    	
 
    	
 
    	
Residual   Solvents Method
    	
 
    	
17 days
    	
 
    	
11/10/03
    	
 
    	
12/2/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion   Lead/USL Support
    	
 
    
	
36
    	
 
    	

    	
 
    	
Verify   residual solvents method validated by vendor, request copy if available
    	
 
    	
2 days
    	
 
    	
11/10/03
    	
 
    	
11/11/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
37
    	
 
    	
 
    	
 
    	
Write   method transfer protocol (if method is supplied by DS vendor)
    	
 
    	
1 wk
    	
 
    	
11/12/03
    	
 
    	
11/18/03
    	
 
    	
0
    	
%
    	
36
    	
 
    	
Orion
    	
 
    
	
38
    	
 
    	
 
    	
 
    	
Perform   method transfer (Verification of results, 3 batches both suppliers and   reporting/results)(Vendor qualification for OVI)
    	
 
    	
2 wks
    	
 
    	
11/19/03
    	
 
    	
12/2/03
    	
 
    	
0
    	
%
    	
37
    	
 
    	
Orion   Lead/USL Support
    	
 
    
	
39
    	
 
    	
 
    	
 
    	
Drug   Product Excipients
    	
 
    	
40 days
    	
 
    	
11/10/03
    	
 
    	
1/15/04
    	
 
    	
0
    	
%
    	
3FS+5   days
    	
 
    	
 
    	
 
    
	
40
    	
 
    	
 
    	
 
    	
Confirm   specifications and test methods conform to USP
    	
 
    	
6 wks
    	
 
    	
11/10/03
    	
 
    	
12/19/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
41
    	
 
    	

    	
 
    	
DMFs,   Debarments and cGMP documents from suppliers
    	
 
    	
8 wks
    	
 
    	
11/10/03
    	
 
    	
1/15/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
42
    	
 
    	
 
    	
 
    	
specification   and methods ready to use
    	
 
    	
2 days
    	
 
    	
12/29/03
    	
 
    	
1/5/04
    	
 
    	
0
    	
%
    	
40
    	
 
    	
Orion
    	
 
    
	
43
    	
 
    	
 
    	
 
    	
Drug   Product Studies
    	
 
    	
55 days
    	
 
    	
11/10/03
    	
 
    	
2/5/04
    	
 
    	
0
    	
%
    	
3FS+5   days
    	
 
    	
 
    	
 
    
	
44
    	
 
    	

    	
 
    	
Tabulate   release data from the DP lots used for tox, stability and clinical, including   formulation number, packaging material, DS lot numbers used, release   limits, etc. Provide C of A’s see notes
    	
 
    	
8 wks
    	
 
    	
11/17/03
    	
 
    	
1/22/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
45
    	
 
    	

    	
 
    	
DP   stress study to ID degradants if found under ICH conditions to be above 0.1%   ; 0.5% specification and 0.1% reporting requirement
    	
 
    	
8 wks
    	
 
    	
11/10/03
    	
 
    	
1/15/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
46
    	
 
    	
 
    	
 
    	
Provide   or conduct studies to show conclusively that DP prepared from the two API   sources provide identical degradation/impurity profiles and that the EF-108   formulation does not have a different impurity/degradation profile from the   original formulation.
    	
 
    	
8 wks
    	
 
    	
11/10/03
    	
 
    	
1/15/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
47
    	
 
    	
 
    	
 
    	
Provide   the name/chemical structure for drug product degradants.
    	
 
    	
8 wks
    	
 
    	
11/10/03
    	
 
    	
1/15/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
48
    	
 
    	
 
    	
 
    	
Use   Test
    	
 
    	
55 days
    	
 
    	
11/10/03
    	
 
    	
2/5/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
49
    	
 
    	

    	
 
    	
Write   protocol for patient use test (IC laminate)
    	
 
    	
4 wks
    	
 
    	
11/10/03
    	
 
    	
12/5/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
50
    	
 
    	

    	
 
    	
Review   of protocol by USL
    	
 
    	
1 wk
    	
 
    	
12/8/03
    	
 
    	
12/12/03
    	
 
    	
0
    	
%
    	
49
    	
 
    	
USL
    	
 
    
	
51
    	
 
    	
 
    	
 
    	
Finalize   protocol
    	
 
    	
1 wk
    	
 
    	
12/15/03
    	
 
    	
12/19/03
    	
 
    	
0
    	
%
    	
50
    	
 
    	
Orion
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

68

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
52
    	
 
    	
 
    	
 
    	
Perform   use test 0.25, 0.5, 1.0 and [***] dose packages
    	
 
    	
3 wks
    	
 
    	
12/29/03
    	
 
    	
1/22/04
    	
 
    	
0
    	
%
    	
51
    	
 
    	
Orion
    	
 
    
	
53
    	
 
    	
 
    	
 
    	
Finalize   report that defines and justifies fill volume
    	
 
    	
2 wks
    	
 
    	
1/23/04
    	
 
    	
2/5/04
    	
 
    	
0
    	
%
    	
52
    	
 
    	
Orion
    	
 
    
	
54
    	
 
    	
 
    	
 
    	
DP   Analytical Methods/Validation
    	
 
    	
60 days
    	
 
    	
11/10/03
    	
 
    	
2/12/04
    	
 
    	
0
    	
%
    	
3FS+5   days
    	
 
    	
Orion
    	
 
    
	
55
    	
 
    	

    	
 
    	
Present   data to support standard solution stability conclusion given on page 200206
    	
 
    	
1 wk
    	
 
    	
1/30/04
    	
 
    	
2/5/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
56
    	
 
    	

    	
 
    	
Validation   of HPLC Assay - Provide or perform specificity validation for EF-108   formulation with new ingredients. (Forced Degradation)
    	
 
    	
8 wks
    	
 
    	
12/1/03
    	
 
    	
2/5/04
    	
 
    	
0
    	
%
    	
33SS
    	
 
    	
Orion
    	
 
    
	
57
    	
 
    	

    	
 
    	
Provide   the viscosity test sample size for release method and validation -11g
    	
 
    	
1 wk
    	
 
    	
11/10/03
    	
 
    	
11/14/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
58
    	
 
    	
 
    	
 
    	
Provide   copy of all final analytical method validation documents,
    	
 
    	
1 wk
    	
 
    	
2/6/04
    	
 
    	
2/12/04
    	
 
    	
0
    	
%
    	
56
    	
 
    	
Orion
    	
 
    
	
59
    	
 
    	
 
    	
 
    	
DP   Specifications
    	
 
    	
75 days
    	
 
    	
11/10/03
    	
 
    	
3/4/04
    	
 
    	
0
    	
%
    	
3FS+5   days
    	
 
    	
Orion
    	
 
    
	
60
    	
 
    	

    	
 
    	
Will   Be Outsourced -Develop in vitro release test and specification limits per SUPAC   Guidance, May 1997, page 19 (which means a Franz cell method) and qualify   pivotal clinical studThis in-vitro method will also be used for future formulation   changes.
    	
 
    	
15 wks
    	
 
    	
11/10/03
    	
 
    	
3/4/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
61
    	
 
    	

    	
 
    	
Perform   Microbial Challenge Test USP<51>(Antimicrobial Effectiveness Testing)   or other relevant studies and provide report, see notes
    	
 
    	
9 wks
    	
 
    	
11/10/03
    	
 
    	
1/22/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
62
    	
 
    	

    	
 
    	
Statement   from Orion that there have been no microbial limit testing failures over X   Years and Y Batches
    	
 
    	
10 wks
    	
 
    	
11/10/03
    	
 
    	
1/29/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
63
    	
 
    	
 
    	
 
    	
US   specifications and methods, 0.5g, 1g and [***]
    	
 
    	
25 days
    	
 
    	
1/30/04
    	
 
    	
3/4/04
    	
 
    	
0
    	
%
    	
30
    	
 
    	
Orion
    	
 
    
	
64
    	
 
    	
 
    	
 
    	
Development   of specification and methods
    	
 
    	
4 wks
    	
 
    	
1/30/04
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
65
    	
 
    	
 
    	
 
    	
Write   report justifying DP specifications
    	
 
    	
1 wk
    	
 
    	
2/27/04
    	
 
    	
3/4/04
    	
 
    	
0
    	
%
    	
67,68,69,70,71
    	
 
    	
 
    	
 
    
	
66
    	
 
    	

    	
 
    	
Perform   the content uniformity per USP weight variation on each batch release. If   required by FDA perform individual assays and provide copy of method. Note   Sept 12 update
    	
 
    	
4 wks
    	
 
    	
1/30/04
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
64FF
    	
 
    	
Orion
    	
 
    
	
67
    	
 
    	

    	
 
    	
Change   Uniformity of Mass to USP “Minimum Fill”, Follow USP limits, see notes (Sent   to Orion via Email)
    	
 
    	
4 wks
    	
 
    	
1/30/04
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
64FF
    	
 
    	
Orion
    	
 
    
	
68
    	
 
    	
 
    	
 
    	
Change   specifications such that content uniformity, related substance assay, and   viscosity measurements are performed for every drug product batch. (Testing   of only every 10th batch is not acceptable.)
    	
 
    	
4 wks
    	
 
    	
1/30/04
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
64FF
    	
 
    	
Orion
    	
 
    
	
69
    	
 
    	
 
    	
 
    	
Add   Ethanol assay test and acceptance criteria per FDA. Provide copy of test   method and validation document
    	
 
    	
4 wks
    	
 
    	
1/30/04
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
64FF
    	
 
    	
Orion
    	
 
    
	
70
    	
 
    	
 
    	
 
    	
Modify   pH limits probably from 4.0 — 6.0 to 4.5 — 5.5 since minimum seen to date is   4.8 and maximum is 5.1
    	
 
    	
4 whs
    	
 
    	
1/30/04
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
64FF
    	
 
    	
Orion
    	
 
    
	
71
    	
 
    	
 
    	
 
    	
DP   -Change single related substance from Max 1.0% to 0.5% (per ICH Guidance Q3BR   5 February 2003), e.g., for 1 mg/day maximum dose for doses >1 mg/day   i.e. 1.0 and [***] strengths
    	
 
    	
4 wks
    	
 
    	
1/30/04
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
54FF
    	
 
    	
Orion
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

69

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
72
    	
 
    	
 
    	
 
    	
US   specifications and methods, 0.5g, 1g and [***] ready to use in systems
    	
 
    	
4 wks
    	
 
    	
1/30/04
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
64FF
    	
 
    	
 
    	
 
    
	
73
    	
 
    	

    	
 
    	
Provide   details of reference standards used for estradiol assay — purchased from USP,   EP, or characterized in-house? (Should use USP reference standard or show   equivalence to USP RS). See notes
    	
 
    	
4 wks
    	
 
    	
1/30/04
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
64FF
    	
 
    	
Orion
    	
 
    
	
74
    	
 
    	
 
    	
 
    	
DP   Container/Closure
    	
 
    	
40 days
    	
 
    	
11/10/03
    	
 
    	
1/15/04
    	
 
    	
0
    	
%
    	
3FS+5   days
    	
 
    	
Orion
    	
 
    
	
75
    	
 
    	

    	
 
    	
Obtain   DMF,cGMP certificate and debarment for the IC container/closure system for   components and fabrication See Notes
    	
 
    	
8 wks
    	
 
    	
11/10/03
    	
 
    	
1/15/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
76
    	
 
    	
 
    	
 
    	
Provide   history of laminates: current versus those used in stability batches, ELI,   ELIIA. ELIIB, etc. Short History of one paragraph to be included in the Product   development summary for IND submission
    	
 
    	
8 wks
    	
 
    	
11/10/03
    	
 
    	
1/15/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
77
    	
 
    	
 
    	
 
    	
IR   test development for Laminate IC — Internal test
    	
 
    	
3 wks
    	
 
    	
11/10/03
    	
 
    	
11/28/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
78
    	
 
    	
 
    	
 
    	
Updated   specification and method ready to use
    	
 
    	
3 wks
    	
 
    	
12/1/03
    	
 
    	
12/19/03
    	
 
    	
0
    	
%
    	
77
    	
 
    	
Orion
    	
 
    
	
79
    	
 
    	

    	
 
    	
Provide   existing Leachible/Extractable report
    	
 
    	
8 wks
    	
 
    	
11/10/03
    	
 
    	
1/15/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
80
    	
 
    	

    	
 
    	
DP   Stability - see notes
    	
 
    	
75 days
    	
 
    	
11/10/03
    	
 
    	
3/4/04
    	
 
    	
0
    	
%
    	
3FS+5   days
    	
 
    	
Orion
    	
 
    
	
81
    	
 
    	

    	
 
    	
For   newest DP stability studies in 1C laminate (started May 2003), provide details,   e.g., number of batches, package sizes stored, drug substance suppliers,   protocols including pull dates. It is suggested that the 30’C/60%RH samples   be stored but not les
    	
 
    	
4 wks
    	
 
    	
11/10/03
    	
 
    	
12/5/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
82
    	
 
    	
 
    	
 
    	
Provide   Stability protocols
    	
 
    	
1 wk
    	
 
    	
2/27/04
    	
 
    	
3/4/04
    	
 
    	
0
    	
%
    	
64
    	
 
    	
 
    	
 
    
	
83
    	
 
    	
 
    	
 
    	
Provide   formulation EF-108 in IB stability data in ICH format as supportive 
    	
 
    	
1 wk 
    	
 
    	
2/27/04
    	
 
    	
3/4/04
    	
 
    	
0
    	
%
    	
82FF
    	
 
    	
 
    	
 
    
	
84
    	
 
    	
 
    	
 
    	
Provide   EF-108 formulation in IC stability data as primary 
    	
 
    	
1 wk
    	
 
    	
2/27/04
    	
 
    	
3/4/04
    	
 
    	
0
    	
%
    	
82FF
    	
 
    	
 
    	
 
    
	
85
    	
 
    	
 
    	
 
    	
Perform   ICH Light Stability study for DP in sealed sachets. Since ethanol will evaporate   from open dish, expose solution (gel) in sealed quartz bottles for one lot of   drug product.
    	
 
    	
4 wks
    	
 
    	
2/6/04
    	
 
    	
3/4/04
    	
 
    	
0
    	
%
    	
82FF
    	
 
    	
Orion
    	
 
    
	
86
    	
 
    	
 
    	
 
    	
Perform   a freeze-thaw stability study on the DP
    	
 
    	
4 wks
    	
 
    	
2/6/04
    	
 
    	
3/4/04
    	
 
    	
0
    	
%
    	
82FF
    	
 
    	
Orion
    	
 
    
	
87
    	
 
    	
 
    	
 
    	
CMC   Tasks -Not linked to IND-EXCEPT 94,95,108,115
    	
 
    	
125 days
    	
 
    	
11/10/03
    	
 
    	
5/13/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
88
    	
 
    	
 
    	
 
    	
Stability   batch 
    	
 
    	
1 day
    	
 
    	
4/30/04
    	
 
    	
4/30/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
89
    	
 
    	
 
    	
 
    	
3rd   stability batch (=clinical batch) to stability studies .5, 1.0, [***] dosages
    	
 
    	
1 day
    	
 
    	
4/30/04
    	
 
    	
4/30/04
    	
 
    	
0
    	
%
    	
113,82
    	
 
    	
Orion
    	
 
    
	
90
    	
 
    	
 
    	
 
    	
Manufacture   small 0.25 batches for stability study
    	
 
    	
125 days
    	
 
    	
11/10/03
    	
 
    	
5/13/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
91
    	
 
    	

    	
 
    	
Manufacture
    	
 
    	
1 wk
    	
 
    	
12/1/03
    	
 
    	
12/5/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
92
    	
 
    	

    	
 
    	
Packages
    	
 
    	
1 wk
    	
 
    	
12/1/03
    	
 
    	
12/5/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
93
    	
 
    	
 
    	
 
    	
Analysis
    	
 
    	
2 wks
    	
 
    	
12/8/03
    	
 
    	
12/19/03
    	
 
    	
0
    	
%
    	
92
    	
 
    	
Orion
    	
 
    
	
94
    	
 
    	

    	
 
    	
0.25g   stability study initiation
    	
 
    	
2 days
    	
 
    	
1/7/04
    	
 
    	
1/8/04
    	
 
    	
0
    	
%
    	
93
    	
 
    	
Orion
    	
 
    
	
95
    	
 
    	
 
    	
 
    	
1   month stability data available for 0.25g
    	
 
    	
6 wks
    	
 
    	
1/9/04
    	
 
    	
2/19/04
    	
 
    	
0
    	
%
    	
94
    	
 
    	
Orion
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

70

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
96
    	
 
    	
 
    	
 
    	
Drug   Product Manufacture
    	
 
    	
65 days
    	
 
    	
11/10/03
    	
 
    	
2/19/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
97
    	
 
    	
 
    	
 
    	
Material   master USA bulk gel ready to use in systems
    	
 
    	
2 wks
    	
 
    	
11/10/03
    	
 
    	
11/21/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
98
    	
 
    	
 
    	
 
    	
Material   masters USA packaging 0.5g 1g and [***] ready to use in systems
    	
 
    	
2 wks
    	
 
    	
2/6/04
    	
 
    	
2/19/04
    	
 
    	
0
    	
%
    	
78,53,108
    	
 
    	
Orion
    	
 
    
	
99
    	
 
    	
 
    	
 
    	
Development   of 0.25 mg dose
    	
 
    	
70 days
    	
 
    	
11/10/03
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
3FS+5   days
    	
 
    	
Orion
    	
 
    
	
100
    	
 
    	
 
    	
 
    	
0.1%   gel in 0.25g dose package
    	
 
    	
70 days
    	
 
    	
11/10/03
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
101
    	
 
    	
 
    	
 
    	
Finalize   report that defines and justifies fill volume
    	
 
    	
2 wks
    	
 
    	
1/23/04
    	
 
    	
2/5/04
    	
 
    	
0
    	
%
    	
52
    	
 
    	
Orion
    	
 
    
	
102
    	
 
    	
 
    	
 
    	
method   development
    	
 
    	
1 wk
    	
 
    	
11/10/03
    	
 
    	
11/14/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
103
    	
 
    	
 
    	
 
    	
specification   and methods ok in systems
    	
 
    	
3 wks
    	
 
    	
2/6/04
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
102,101
    	
 
    	
Orion
    	
 
    
	
104
    	
 
    	
 
    	
 
    	
method   validation
    	
 
    	
3 wks
    	
 
    	
11/17/03
    	
 
    	
12/5/03
    	
 
    	
0
    	
%
    	
102
    	
 
    	
Orion
    	
 
    
	
105
    	
 
    	
 
    	
 
    	
master   documents for packaging
    	
 
    	
2 wks
    	
 
    	
2/6/04
    	
 
    	
2/19/04
    	
 
    	
0
    	
%
    	
101
    	
 
    	
Orion
    	
 
    
	
106
    	
 
    	
 
    	
 
    	
Manufacturing   of clinical batches (all sizes)
    	
 
    	
125 days
    	
 
    	
11/10/03
    	
 
    	
5/13/04
    	
 
    	
0
    	
%
    	
3FS+5   days
    	
 
    	
 
    	
 
    
	
107
    	
 
    	

    	
 
    	
Drug order USL
    	
 
    	
1 day
    	
 
    	
12/1/03
    	
 
    	
12/1/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
108
    	
 
    	

    	
 
    	
Sachet   printing information from USL Printed online during production.
    	
 
    	
4.8 wks
    	
 
    	
11/10/03
    	
 
    	
12/11/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
109
    	
 
    	
 
    	
 
    	
Raw   material analyses
    	
 
    	
3 wks
    	
 
    	
1/30/04
    	
 
    	
2/19/04
    	
 
    	
0
    	
%
    	
42,30
    	
 
    	
Orion
    	
 
    
	
110
    	
 
    	
 
    	
 
    	
Manufacturing   of (EF108) bulk gels (placebo and actives)
    	
 
    	
1 wk
    	
 
    	
2/27/04
    	
 
    	
3/4/04
    	
 
    	
0
    	
%
    	
109,97,103
    	
 
    	
Orion
    	
 
    
	
111
    	
 
    	
 
    	
 
    	
Packaging   of clinical samples (filling into sachets)
    	
 
    	
2 wks
    	
 
    	
3/5/04
    	
 
    	
3/18/04
    	
 
    	
0
    	
%
    	
110,123,117,98
    	
 
    	
Orion
    	
 
    
	
112
    	
 
    	
 
    	
 
    	
Analyses
    	
 
    	
4 wks
    	
 
    	
3/19/04
    	
 
    	
4/15/04
    	
 
    	
0
    	
%
    	
111,121,118,72
    	
 
    	
Orion
    	
 
    
	
113
    	
 
    	
 
    	
 
    	
Release
    	
 
    	
2 wks
    	
 
    	
4/16/04
    	
 
    	
4/29/04
    	
 
    	
0
    	
%
    	
112
    	
 
    	
Orion
    	
 
    
	
114
    	
 
    	
 
    	
 
    	
Shipment   to USL (if clinical packaging not at Orion)
    	
 
    	
2 wks
    	
 
    	
4/30/04
    	
 
    	
5/13/04
    	
 
    	
0
    	
%
    	
113
    	
 
    	
Orion
    	
 
    
	
115
    	
 
    	

    	
 
    	
Provide   to USL copy of current master manufacturing directions and in-process   controls for bulk and filling
    	
 
    	
77 days
    	
 
    	
11/10/03
    	
 
    	
3/8/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
116
    	
 
    	
 
    	
 
    	
Development   of placebo for 0.25g dose package
    	
 
    	
65 days
    	
 
    	
11/10/03
    	
 
    	
2/19/04
    	
 
    	
0
    	
%
    	
3FS+5   days
    	
 
    	
Orion
    	
 
    
	
117
    	
 
    	
 
    	
 
    	
Master   document for packaging
    	
 
    	
2 wks
    	
 
    	
2/6/04
    	
 
    	
2/19/04
    	
 
    	
0
    	
%
    	
101
    	
 
    	
Orion
    	
 
    
	
118
    	
 
    	
 
    	
 
    	
Specification   and methods ok in systems
    	
 
    	
6 wks
    	
 
    	
11/10/03
    	
 
    	
12/19/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
119
    	
 
    	
 
    	
 
    	
Development   of placebo for 0.5g 1.0g and [***]
    	
 
    	
65 days
    	
 
    	
11/10/03
    	
 
    	
2/19/04
    	
 
    	
0
    	
%
    	
3FS+5   days
    	
 
    	
Orion
    	
 
    
	
120
    	
 
    	
 
    	
 
    	
Method   development
    	
 
    	
2 wks
    	
 
    	
11/10/03
    	
 
    	
11/21/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
121
    	
 
    	
 
    	
 
    	
Specifications   and methods ok in systems
    	
 
    	
4 wks
    	
 
    	
11/24/03
    	
 
    	
12/19/03
    	
 
    	
0
    	
%
    	
120
    	
 
    	
Orion
    	
 
    
	
122
    	
 
    	
 
    	
 
    	
Master   documents for bulk gel manufacturing
    	
 
    	
2 wks
    	
 
    	
1/6/04
    	
 
    	
1/19/04
    	
 
    	
0
    	
%
    	
42
    	
 
    	
Orion
    	
 
    
	
123
    	
 
    	
 
    	
 
    	
Master   documents for packaging
    	
 
    	
2 wks
    	
 
    	
2/6/04
    	
 
    	
2/19/04
    	
 
    	
0
    	
%
    	
53
    	
 
    	
Orion
    	
 
    
	
124
    	
 
    	
 
    	
 
    	
Clinical   Tasks
    	
 
    	
94 days
    	
 
    	
11/10/03
    	
 
    	
3/31/04
    	
 
    	
0
    	
%
    	
3FS+5   days
    	
 
    	
 
    	
 
    
	
125
    	
 
    	
 
    	
 
    	
Pharmacokinetics   - (Phase I)
    	
 
    	
62 days
    	
 
    	
11/10/03
    	
 
    	
2/16/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
126
    	
 
    	
 
    	
 
    	
Pharmacokinetics   Summary
    	
 
    	
22 days
    	
 
    	
11/10/03
    	
 
    	
12/9/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
127
    	
 
    	
 
    	
 
    	
Create   summary of existing PK studies for IND submission
    	
 
    	
4 wks
    	
 
    	
11/10/03
    	
 
    	
12/5/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   Lead/Orion Support
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

71

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith   Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development   Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
128
    	
 
    	
 
    	
 
    	
Submit summary to FDA   with IND submission
    	
 
    	
2 days
    	
 
    	
12/8/03
    	
 
    	
12/9/03
    	
 
    	
0
    	
%
    	
127
    	
 
    	
 
    	
 
    
	
129
    	
 
    	
 
    	
 
    	
PK Study
    	
 
    	
36 days
    	
 
    	
12/16/03
    	
 
    	
2/16/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
130
    	
 
    	
 
    	
 
    	
Draft Phase I Protocol
    	
 
    	
4 wks
    	
 
    	
12/16/03
    	
 
    	
1/23/04
    	
 
    	
0
    	
%
    	
256
    	
 
    	
CRO
    	
 
    
	
131
    	
 
    	
 
    	
 
    	
Review Protocol
    	
 
    	
2 wks
    	
 
    	
1/26/04
    	
 
    	
2/6/04
    	
 
    	
0
    	
%
    	
130
    	
 
    	
USL
    	
 
    
	
132
    	
 
    	
 
    	
 
    	
Finalize Protocol
    	
 
    	
1 wk
    	
 
    	
2/9/04
    	
 
    	
2/13/04
    	
 
    	
0
    	
%
    	
131
    	
 
    	
USL/CRO
    	
 
    
	
133
    	
 
    	
 
    	
 
    	
Submit Protocol to FDA   with IND submission
    	
 
    	
1 day
    	
 
    	
2/16/04
    	
 
    	
2/16/04
    	
 
    	
0
    	
%
    	
132
    	
 
    	
USL
    	
 
    
	
134
    	
 
    	
 
    	
 
    	
Transferability Study
    	
 
    	
36 days
    	
 
    	
11/10/03
    	
 
    	
1/9/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
135
    	
 
    	
 
    	
 
    	
Draft Phase I Protocol
    	
 
    	
4 wks
    	
 
    	
11/10/03
    	
 
    	
12/5/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
CRO
    	
 
    
	
136
    	
 
    	
 
    	
 
    	
Review Protocol
    	
 
    	
2 wks
    	
 
    	
12/8/03
    	
 
    	
12/19/03
    	
 
    	
0
    	
%
    	
135
    	
 
    	
USL
    	
 
    
	
137
    	
 
    	
 
    	
 
    	
Finalize Protocol
    	
 
    	
1 wk
    	
 
    	
12/29/03
    	
 
    	
1/8/04
    	
 
    	
0
    	
%
    	
136
    	
 
    	
USL/CRO
    	
 
    
	
138
    	
 
    	
 
    	
 
    	
Submit Protocol to FDA   with IND submission
    	
 
    	
1 day
    	
 
    	
1/9/04
    	
 
    	
1/9/04
    	
 
    	
0
    	
%
    	
137
    	
 
    	
USL
    	
 
    
	
139
    	
 
    	
 
    	
 
    	
Washability Study
    	
 
    	
36 days
    	
 
    	
11/10/03
    	
 
    	
1/9/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
140
    	
 
    	
 
    	
 
    	
Draft Phase I Protocol
    	
 
    	
4 wks
    	
 
    	
11/10/03
    	
 
    	
12/5/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
CRO
    	
 
    
	
141
    	
 
    	
 
    	
 
    	
Review Protocol
    	
 
    	
2 wks
    	
 
    	
12/8/03
    	
 
    	
12/19/03
    	
 
    	
0
    	
%
    	
140
    	
 
    	
USL
    	
 
    
	
142
    	
 
    	
 
    	
 
    	
Finalize Protocol
    	
 
    	
1 wk
    	
 
    	
12/29/03
    	
 
    	
1/8/04
    	
 
    	
0
    	
%
    	
141
    	
 
    	
USL/CRO
    	
 
    
	
143
    	
 
    	
 
    	
 
    	
Submit Protocol to FDA   with IND submission
    	
 
    	
1 day
    	
 
    	
1/9/04
    	
 
    	
1/9/04
    	
 
    	
0
    	
%
    	
142
    	
 
    	
USL
    	
 
    
	
144
    	
 
    	
 
    	
 
    	
Non-Clinical   Pharmacology
    	
 
    	
22 days
    	
 
    	
11/10/03
    	
 
    	
12/9/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
145
    	
 
    	
 
    	
 
    	
Create summary of   existing non- clinical Pharm studies for IND submission
    	
 
    	
4 wks
    	
 
    	
11/10/03
    	
 
    	
12/5/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL Lead/Orion Support
    	
 
    
	
146
    	
 
    	
 
    	
 
    	
Submit summary to FDA   with IND submission
    	
 
    	
2 days
    	
 
    	
12/8/03
    	
 
    	
12/9/03
    	
 
    	
0
    	
%
    	
145
    	
 
    	
 
    	
 
    
	
147
    	
 
    	
 
    	
 
    	
Pharmacology
    	
 
    	
22 days
    	
 
    	
11/10/03
    	
 
    	
12/9/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
148
    	
 
    	
 
    	
 
    	
Create summary of   existing Pharm studies for IND submission
    	
 
    	
4 wks
    	
 
    	
11/10/03
    	
 
    	
12/5/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL Lead/Orion Support
    	
 
    
	
149
    	
 
    	
 
    	
 
    	
Submit summary to FDA   with IND submission
    	
 
    	
2 days
    	
 
    	
12/8/03
    	
 
    	
12/9/03
    	
 
    	
0
    	
%
    	
148
    	
 
    	
 
    	
 
    
	
150
    	
 
    	
 
    	
 
    	
Toxicology
    	
 
    	
22 days
    	
 
    	
11/10/03
    	
 
    	
12/9/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
151
    	
 
    	
 
    	
 
    	
Create summary of   existing Tox studies for IND submission
    	
 
    	
4 wks
    	
 
    	
11/10/03
    	
 
    	
12/5/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL Lead/Orion Support
    	
 
    
	
152
    	
 
    	
 
    	
 
    	
Submit summary to FDA   with IND submission
    	
 
    	
2 days
    	
 
    	
12/8/03
    	
 
    	
12/9/03
    	
 
    	
0
    	
%
    	
151
    	
 
    	
 
    	
 
    
	
153
    	
 
    	
 
    	
 
    	
Clinical Studies
    	
 
    	
94 days
    	
 
    	
11/10/03
    	
 
    	
3/31/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
154
    	
 
    	
 
    	
 
    	
Clinical Development   Plan (CDP)
    	
 
    	
48 days
    	
 
    	
1/26/04
    	
 
    	
3/31/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
155
    	
 
    	
 
    	
 
    	
Planning meeting with   CRO
    	
 
    	
2 wks
    	
 
    	
1/26/04
    	
 
    	
2/6/04
    	
 
    	
0
    	
%
    	
296
    	
 
    	
USL
    	
 
    
	
156
    	
 
    	
 
    	
 
    	
Draft CDP
    	
 
    	
2 wks
    	
 
    	
2/9/04
    	
 
    	
2/20/04
    	
 
    	
0
    	
%
    	
155
    	
 
    	
USL Lead/Orion Support
    	
 
    
	
157
    	
 
    	
 
    	
 
    	
Review CDP
    	
 
    	
2 wks
    	
 
    	
2/23/04
    	
 
    	
3/5/04
    	
 
    	
0
    	
%
    	
156
    	
 
    	
USL Lead/Orion Support
    	
 
    
	
158
    	
 
    	
 
    	
 
    	
Final Draft of CDP
    	
 
    	
2 wks
    	
 
    	
3/8/04
    	
 
    	
3/19/04
    	
 
    	
0
    	
%
    	
157
    	
 
    	
USL Lead/Orion Support
    	
 
    
	
159
    	
 
    	
 
    	
 
    	
Review Final Draft Of   CDP
    	
 
    	
1 wk
    	
 
    	
3/29/04
    	
 
    	
3/26/04
    	
 
    	
0
    	
%
    	
158
    	
 
    	
USL Lead/Orion Support
    	
 
    
	
160
    	
 
    	
 
    	
 
    	
Sign off CDP
    	
 
    	
3 days
    	
 
    	
3/29/04
    	
 
    	
3/31/04
    	
 
    	
0
    	
%
    	
159
    	
 
    	
USL Lead/Orion Support
    	
 
    
	
161
    	
 
    	
 
    	
 
    	
Phase III
    	
 
    	
45 days
    	
 
    	
1/26/04
    	
 
    	
3/26/04
    	
 
    	
0
    	
%
    	
3FS+5 days
    	
 
    	
 
    	
 
    
	
162
    	
 
    	

    	
 
    	
Draft protocol
    	
 
    	
6 wks
    	
 
    	
1/26/04
    	
 
    	
3/5/04
    	
 
    	
0
    	
%
    	
296
    	
 
    	
CRO
    	
 
    

 

	
11/24/03 12:19 PM
    	
 
    	
Kingfisher Final   Development Timeline.mpp
    
	
 
    	
Approved   Timeline
    	
 
    

 

72

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
163
    	
 
    	
 
    	
 
    	
Review   protocol
    	
 
    	
2 wks
    	
 
    	
3/8/04
    	
 
    	
3/19/04
    	
 
    	
0
    	
%
    	
162
    	
 
    	
USL
    	
 
    
	
164
    	
 
    	
 
    	
 
    	
Review   protocol by expert panel
    	
 
    	
2 wks
    	
 
    	
3/8/04
    	
 
    	
3/19/04
    	
 
    	
0
    	
%
    	
162
    	
 
    	
USL
    	
 
    
	
165
    	
 
    	
 
    	
 
    	
Finalize   protocol
    	
 
    	
2 wks
    	
 
    	
3/8/04
    	
 
    	
3/19/04
    	
 
    	
0
    	
%
    	
164FF
    	
 
    	
USL   CRO
    	
 
    
	
166
    	
 
    	
 
    	
 
    	
Submit   protocol to FDA with IND
    	
 
    	
1 wk
    	
 
    	
3/22/04
    	
 
    	
3/26/04
    	
 
    	
0
    	
%
    	
165
    	
 
    	
USL
    	
 
    
	
167
    	
 
    	
 
    	
 
    	
Investigator   Drug Brochure (IDB)
    	
 
    	
35 days
    	
 
    	
1/26/04
    	
 
    	
3/12/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion   Lead/USL Support
    	
 
    
	
168
    	
 
    	
 
    	
 
    	
CRO   Draft Investigator Brochure
    	
 
    	
4 wks
    	
 
    	
1/26/04
    	
 
    	
2/20/04
    	
 
    	
0
    	
%
    	
296
    	
 
    	
Orion   Lead/USL Support
    	
 
    
	
169
    	
 
    	
 
    	
 
    	
USL   Review of Investigator Brochure
    	
 
    	
2wks
    	
 
    	
2/23/04
    	
 
    	
3/5/04
    	
 
    	
0
    	
%
    	
168
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
170
    	
 
    	
 
    	
 
    	
Finalize   IDB
    	
 
    	
1 wk
    	
 
    	
3/8/04
    	
 
    	
3/12/04
    	
 
    	
0
    	
%
    	
169
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
171
    	
 
    	
 
    	
 
    	
Previous   Human Experience
    	
 
    	
30 days
    	
 
    	
11/10/03
    	
 
    	
12/19/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion   Lead/USL Support
    	
 
    
	
172
    	
 
    	
 
    	
 
    	
Summary   of existing studies
    	
 
    	
6wks
    	
 
    	
11/10/03
    	
 
    	
12/19/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion   Lead/USL Support
    	
 
    
	
173
    	
 
    	
 
    	
 
    	
General   Tasks For IND Submission
    	
 
    	
15 days
    	
 
    	
1/26/04
    	
 
    	
2/13/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
174
    	
 
    	
 
    	
 
    	
Clinical   Tasks
    	
 
    	
15 days
    	
 
    	
1/26/04
    	
 
    	
2/13/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
175
    	
 
    	
 
    	
 
    	
Prepare   clinical and toxicology reports
    	
 
    	
3 wks
    	
 
    	
1/26/04
    	
 
    	
2/13/04
    	
 
    	
0
    	
%
    	
296
    	
 
    	
USL   and Orion
    	
 
    
	
176
    	
 
    	
 
    	
 
    	
IND   Submission Tasks
    	
 
    	
119 days
    	
 
    	
10/13/03
    	
 
    	
4/7/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
177
    	
 
    	
 
    	
 
    	
Milestone   Task - All CMC tasks ready for IND documentation
    	
 
    	
0 days
    	
 
    	
3/4/04
    	
 
    	
3/4/04
    	
 
    	
0
    	
%
    	
10
    	
 
    	
 
    	
 
    
	
178
    	
 
    	
 
    	
 
    	
Milestone   Task - All Clinical tasks ready for IND documentation
    	
 
    	
0 days
    	
 
    	
3/31/04
    	
 
    	
3/31/04
    	
 
    	
0
    	
%
    	
173,124
    	
 
    	
 
    	
 
    
	
179
    	
 
    	
 
    	
 
    	
Send   “most current/complete” registration document for marketed dosage forms (both   electronically [as available] and in hard copy)
    	
 
    	
1 wk
    	
 
    	
10/13/03
    	
 
    	
10/17/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
180
    	
 
    	
 
    	
 
    	
Prepare   draft of CMC documents from registration document
    	
 
    	
6 wks
    	
 
    	
10/20/03
    	
 
    	
11/28/03
    	
 
    	
0
    	
%
    	
179
    	
 
    	
USL   DR
    	
 
    
	
181
    	
 
    	
 
    	
 
    	
Request   additional details of existing studies
    	
 
    	
2 wks
    	
 
    	
11/17/03
    	
 
    	
11/28/03
    	
 
    	
0
    	
%
    	
180FF
    	
 
    	
USL   DR
    	
 
    
	
182
    	
 
    	
 
    	
 
    	
Provide   additional details of existing studies
    	
 
    	
2 wks
    	
 
    	
12/1/03
    	
 
    	
12/12/03
    	
 
    	
0
    	
%
    	
181
    	
 
    	
Orion
    	
 
    
	
183
    	
 
    	
 
    	
 
    	
Send   comparable documents for 0.25 g fill volume
    	
 
    	
2 wks
    	
 
    	
12/1/03
    	
 
    	
12/12/03
    	
 
    	
0
    	
%
    	
182FF
    	
 
    	
Orion
    	
 
    
	
184
    	
 
    	
 
    	
 
    	
Update   to include 0.25 g dosage form
    	
 
    	
2 wks
    	
 
    	
12/15/03
    	
 
    	
1/8/04
    	
 
    	
0
    	
%
    	
183
    	
 
    	
USL   DR
    	
 
    
	
185
    	
 
    	
 
    	
 
    	
Request   additional details for 0.25 g fill volume
    	
 
    	
2 wks
    	
 
    	
12/15/03
    	
 
    	
1/8/04
    	
 
    	
0
    	
%
    	
184FF
    	
 
    	
USL   DR
    	
 
    
	
186
    	
 
    	
 
    	
 
    	
Provide   additional details for 0.25 g fill volume
    	
 
    	
2 wks
    	
 
    	
12/15/03
    	
 
    	
1/8/04
    	
 
    	
0
    	
%
    	
184FF
    	
 
    	
Orion
    	
 
    
	
187
    	
 
    	
 
    	
 
    	
Provide   data from new CMC studies
    	
 
    	
4 wks
    	
 
    	
12/1/03
    	
 
    	
1/8/04
    	
 
    	
0
    	
%
    	
184FF
    	
 
    	
Orion
    	
 
    
	
188
    	
 
    	
 
    	
 
    	
Incorporate   data from new CMC/Clinical
    	
 
    	
2 wks
    	
 
    	
1/9/04
    	
 
    	
1/22/04
    	
 
    	
0
    	
%
    	
187
    	
 
    	
USL   DR
    	
 
    
	
189
    	
 
    	
 
    	
 
    	
Request   additional details from new CMC studies
    	
 
    	
1 wk
    	
 
    	
1/16/04
    	
 
    	
1/22/04
    	
 
    	
0
    	
%
    	
188FF
    	
 
    	
USL   DR
    	
 
    
	
190
    	
 
    	
 
    	
 
    	
Provide   additional details including COAs for all clinical batches
    	
 
    	
2 wks
    	
 
    	
1/23/04
    	
 
    	
2/5/04
    	
 
    	
0
    	
%
    	
189
    	
 
    	
Orion
    	
 
    
	
191
    	
 
    	
 
    	
 
    	
Provide   1st draft CMC for review
    	
 
    	
0 wks
    	
 
    	
1/30/04
    	
 
    	
1/30/04
    	
 
    	
0
    	
%
    	
190FS-1   wk
    	
 
    	
USL   DR
    	
 
    
	
192
    	
 
    	
 
    	
 
    	
Review   CMC 1st draft
    	
 
    	
2 wks
    	
 
    	
2/20/04
    	
 
    	
3/4/04
    	
 
    	
0
    	
%
    	
191,105
    	
 
    	
Orion/USL
    	
 
    
	
193
    	
 
    	
 
    	
 
    	
Make   revisions to 1st draft CMC
    	
 
    	
2 wks
    	
 
    	
3/5/04
    	
 
    	
3/18/04
    	
 
    	
0
    	
%
    	
192
    	
 
    	
USL   DR
    	
 
    
	
194
    	
 
    	
 
    	
 
    	
Provide   2nd draft CMC for review
    	
 
    	
0 wks
    	
 
    	
3/18/04
    	
 
    	
3/18/04
    	
 
    	
0
    	
%
    	
193
    	
 
    	
USL   DR
    	
 
    
	
195
    	
 
    	
 
    	
 
    	
Review   CMC 2nd draft
    	
 
    	
1 wk
    	
 
    	
3/19/04
    	
 
    	
3/25/04
    	
 
    	
0
    	
%
    	
194
    	
 
    	
Orion   USL
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

73

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
196
    	
 
    	
 
    	
 
    	
Make revisions to 2nd draft CMC (Deadline for all CMC & Clinical   Materials)
    	
 
    	
1 wk
    	
 
    	
4/1/04
    	
 
    	
4/7/04
    	
 
    	
0
    	
%
    	
177.178
    	
 
    	
USL   DR
    	
 
    
	
197
    	
 
    	
 
    	
 
    	
Provide final CMC
    	
 
    	
0 days
    	
 
    	
4/7/04
    	
 
    	
4/7/04
    	
 
    	
0
    	
%
    	
196
    	
 
    	
USL   DR
    	
 
    
	
198
    	
 
    	
 
    	
 
    	
IND Final Prep
    	
 
    	
13 days
    	
 
    	
4/8/04
    	
 
    	
4/26/04
    	
 
    	
0
    	
%
    	
197
    	
 
    	
USL   DR
    	
 
    
	
199
    	
 
    	
 
    	
 
    	
IND Review
    	
 
    	
3 days
    	
 
    	
4/8/04
    	
 
    	
4/12/04
    	
 
    	
0
    	
%
    	
166
    	
 
    	
USL   ORION
    	
 
    
	
200
    	
 
    	
 
    	
 
    	
IND Revisions
    	
 
    	
3 days
    	
 
    	
4/13/04
    	
 
    	
4/15/04
    	
 
    	
0
    	
%
    	
199
    	
 
    	
USL   DR
    	
 
    
	
201
    	
 
    	
 
    	
 
    	
Paginate
    	
 
    	
2 days
    	
 
    	
4/16/04
    	
 
    	
4/19/04
    	
 
    	
0
    	
%
    	
200
    	
 
    	
USL
    	
 
    
	
202
    	
 
    	
 
    	
 
    	
Table of Contents
    	
 
    	
1 day
    	
 
    	
4/20/04
    	
 
    	
4/20/04
    	
 
    	
0
    	
%
    	
201
    	
 
    	
USL
    	
 
    
	
203
    	
 
    	
 
    	
 
    	
Copying
    	
 
    	
1 day
    	
 
    	
4/21/04
    	
 
    	
4/21/04
    	
 
    	
0
    	
%
    	
202
    	
 
    	
USL
    	
 
    
	
204
    	
 
    	
 
    	
 
    	
Color Code & Compile
    	
 
    	
2 days
    	
 
    	
4/22/04
    	
 
    	
4/23/04
    	
 
    	
0
    	
%
    	
203
    	
 
    	
USL
    	
 
    
	
205
    	
 
    	
 
    	
 
    	
Final On-site Review
    	
 
    	
1 day
    	
 
    	
4/26/04
    	
 
    	
4/26/04
    	
 
    	
0
    	
%
    	
204
    	
 
    	
USL
    	
 
    
	
206
    	
 
    	
 
    	
 
    	
Package for Shipment
    	
 
    	
1 day
    	
 
    	
4/26/04
    	
 
    	
4/26/04
    	
 
    	
0
    	
%
    	
204
    	
 
    	
USL
    	
 
    
	
207
    	
 
    	
 
    	
 
    	
Submit IND
    	
 
    	
26 days
    	
 
    	
4/27/04
    	
 
    	
6/1/04
    	
 
    	
0
    	
%
    	
206
    	
 
    	
USL
    	
 
    
	
208
    	
 
    	
 
    	
 
    	
Ship submission
    	
 
    	
1 day
    	
 
    	
4/27/04
    	
 
    	
4/27/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
209
    	
 
    	
 
    	
 
    	
30 Day Wait Trigger
    	
 
    	
25 days
    	
 
    	
4/28/04
    	
 
    	
6/1/04
    	
 
    	
0
    	
%
    	
208
    	
 
    	
 
    	
 
    
	
210
    	
 
    	

    	
 
    	
FDA Informational Meeting
    	
 
    	
41 days
    	
 
    	
4/28/04
    	
 
    	
6/23/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
211
    	
 
    	
 
    	
 
    	
Request Meeting
    	
 
    	
1 day
    	
 
    	
4/28/04
    	
 
    	
4/28/04
    	
 
    	
0
    	
%
    	
208
    	
 
    	
USL
    	
 
    
	
212
    	
 
    	
 
    	
 
    	
Conduct Meeting
    	
 
    	
2 mons
    	
 
    	
4/29/04
    	
 
    	
6/23/04
    	
 
    	
0
    	
%
    	
211
    	
 
    	
USL
    	
 
    
	
213
    	
 
    	
 
    	
 
    	
Post IND CMC Activities
    	
 
    	
290 days
    	
 
    	
5/3/04
    	
 
    	
6/10/05
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
214
    	
 
    	
 
    	
 
    	
CMC Tasks
    	
 
    	
290 days
    	
 
    	
5/3/04
    	
 
    	
6/10/05
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
215
    	
 
    	
 
    	
 
    	
Stability
    	
 
    	
290 days
    	
 
    	
5/3/04
    	
 
    	
6/10/05
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
216
    	
 
    	
 
    	
 
    	
Manufacture two additional 0.25 batches for stability study (2   different suppliers of DS)
    	
 
    	
27 days
    	
 
    	
5/3/04
    	
 
    	
6/8/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
217
    	
 
    	

    	
 
    	
Manufacture
    	
 
    	
2 wks
    	
 
    	
5/3/04
    	
 
    	
5/14/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
218
    	
 
    	
 
    	
 
    	
Packages
    	
 
    	
1 wk
    	
 
    	
5/17/04
    	
 
    	
5/21/04
    	
 
    	
0
    	
%
    	
217
    	
 
    	
Orion
    	
 
    
	
219
    	
 
    	
 
    	
 
    	
Analysis
    	
 
    	
2 wks
    	
 
    	
5/24/04
    	
 
    	
6/4/04
    	
 
    	
0
    	
%
    	
218
    	
 
    	
Orion
    	
 
    
	
220
    	
 
    	
 
    	
 
    	
Stability storage
    	
 
    	
2 days
    	
 
    	
6/7/04
    	
 
    	
6/8/04
    	
 
    	
0
    	
%
    	
219
    	
 
    	
Orion
    	
 
    
	
221
    	
 
    	
 
    	
 
    	
Stability Phase III Lot
    	
 
    	
290 days
    	
 
    	
5/3/04
    	
 
    	
6/10/05
    	
 
    	
0
    	
%
    	
89
    	
 
    	
USL
    	
 
    
	
222
    	
 
    	
 
    	
 
    	
Write & Approve Stability Protocols
    	
 
    	
4 wks
    	
 
    	
5/3/04
    	
 
    	
5/28/04
    	
 
    	
0
    	
%
    	
113FF
    	
 
    	
USL
    	
 
    
	
223
    	
 
    	
 
    	
 
    	
Accelerated stability 40/75
    	
 
    	
7 mons
    	
 
    	
5/31/04
    	
 
    	
12/10/04
    	
 
    	
0
    	
%
    	
222
    	
 
    	
USL
    	
 
    
	
224
    	
 
    	
 
    	
 
    	
QA Audit Accelerated Stability
    	
 
    	
2 wks
    	
 
    	
12/13/04
    	
 
    	
12/24/04
    	
 
    	
0
    	
%
    	
223
    	
 
    	
USL
    	
 
    
	
225
    	
 
    	
 
    	
 
    	
Long term stability on going
    	
 
    	
12 mons
    	
 
    	
5/31/04
    	
 
    	
4/29/05
    	
 
    	
0
    	
%
    	
222
    	
 
    	
USL
    	
 
    
	
226
    	
 
    	
 
    	
 
    	
12month stability complete
    	
 
    	
13 mons
    	
 
    	
5/31/04
    	
 
    	
5/27/05
    	
 
    	
0
    	
%
    	
222
    	
 
    	
USL
    	
 
    
	
227
    	
 
    	
 
    	
 
    	
Audit Stability Data
    	
 
    	
2 wks
    	
 
    	
5/30/05
    	
 
    	
6/10/05
    	
 
    	
0
    	
%
    	
226
    	
 
    	
USL
    	
 
    
	
228
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
229
    	
 
    	
 
    	
 
    	
DP Container/Closure
    	
 
    	
70 days
    	
 
    	
6/2/04
    	
 
    	
9/7/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

74

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
230
    	
 
    	
 
    	
 
    	
Determine   if new Leachables/extractables study must be performed based on FDA   directive.
    	
 
    	
2 wks
    	
 
    	
6/2/04
    	
 
    	
6/15/04
    	
 
    	
0
    	
%
    	
209
    	
 
    	
Orion
    	
 
    
	
231
    	
 
    	
 
    	
 
    	
Perfrom   new leachables/extractables test, if required
    	
 
    	
3 mons
    	
 
    	
6/16/04
    	
 
    	
9/7/04
    	
 
    	
0
    	
%
    	
230
    	
 
    	
 
    	
 
    
	
232
    	
 
    	
 
    	
 
    	
Clinical   Studies
    	
 
    	
564 days
    	
 
    	
10/13/03
    	
 
    	
12/21/05
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
233
    	
 
    	
 
    	
 
    	
Packaging   Selection
    	
 
    	
101 days
    	
 
    	
10/13/03
    	
 
    	
3/12/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
234
    	
 
    	
 
    	
 
    	
USL   to provide number of units and coding/labeling
    	
 
    	
1 wk
    	
 
    	
10/13/03
    	
 
    	
10/17/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
235
    	
 
    	

    	
 
    	
Identify   Packaging
    	
 
    	
4 wks
    	
 
    	
2/2/04
    	
 
    	
2/27/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion   Lead/USL Support
    	
 
    
	
236
    	
 
    	
 
    	
 
    	
Packaging   Samples
    	
 
    	
1 wk
    	
 
    	
3/1/04
    	
 
    	
3/5/04
    	
 
    	
0
    	
%
    	
235
    	
 
    	
Orion   Lead/USL Support
    	
 
    
	
237
    	
 
    	
 
    	
 
    	
Finalize   Packaging selection
    	
 
    	
1 wk
    	
 
    	
3/8/04
    	
 
    	
3/12/04
    	
 
    	
0
    	
%
    	
236
    	
 
    	
Orion   Lead/USL Support
    	
 
    
	
238
    	
 
    	
 
    	
 
    	
Clinical   Study Material Packaging
    	
 
    	
119 days
    	
 
    	
2/2/04
    	
 
    	
7/15/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion   Lead/USL Support
    	
 
    
	
239
    	
 
    	

    	
 
    	
Package   PK, Transferability, Washability study material if in Orion
    	
 
    	
6 wks
    	
 
    	
4/30/04
    	
 
    	
6/10/04
    	
 
    	
0
    	
%
    	
113
    	
 
    	
Orion
    	
 
    
	
240
    	
 
    	

    	
 
    	
Create   Blind Study Packaging
    	
 
    	
2 wks
    	
 
    	
2/2/04
    	
 
    	
2/13/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
241
    	
 
    	

    	
 
    	
Package   Phase III Material if packaging in Orion
    	
 
    	
6 wks
    	
 
    	
4/30/04
    	
 
    	
6/10/04
    	
 
    	
0
    	
%
    	
240,113
    	
 
    	
Orion
    	
 
    
	
242
    	
 
    	
 
    	
 
    	
Package   Sample Packets
    	
 
    	
2 wks
    	
 
    	
4/30/04
    	
 
    	
5/13/04
    	
 
    	
0
    	
%
    	
240,113
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
243
    	
 
    	
 
    	
 
    	
Label/Blind   Phase III Material
    	
 
    	
3 wks
    	
 
    	
6/11/04
    	
 
    	
7/1/04
    	
 
    	
0
    	
%
    	
241
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
244
    	
 
    	
 
    	
 
    	
Ship   Phase III Material to USL
    	
 
    	
1 wk
    	
 
    	
7/2/04
    	
 
    	
7/8/04
    	
 
    	
0
    	
%
    	
243
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
245
    	
 
    	
 
    	
 
    	
Release   of Clinical Material to CRO
    	
 
    	
1 wk
    	
 
    	
7/9/04
    	
 
    	
7/15/04
    	
 
    	
0
    	
%
    	
244
    	
 
    	
USL
    	
 
    
	
246
    	
 
    	
 
    	
 
    	
CRO   Selection
    	
 
    	
66 days
    	
 
    	
10/13/03
    	
 
    	
1/23/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
247
    	
 
    	
 
    	
 
    	
CRO   Selection for PK
    	
 
    	
46 days
    	
 
    	
10/13/03
    	
 
    	
12/15/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
248
    	
 
    	

    	
 
    	
Identify   potential CROs
    	
 
    	
1 day
    	
 
    	
10/13/03
    	
 
    	
10/13/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
249
    	
 
    	
 
    	
 
    	
Put   CDAs in place
    	
 
    	
1 wk
    	
 
    	
10/14/03
    	
 
    	
10/20/03
    	
 
    	
0
    	
%
    	
248
    	
 
    	
USL
    	
 
    
	
250
    	
 
    	
 
    	
 
    	
Develop   questionnaire/RFP
    	
 
    	
1 wk
    	
 
    	
10/21/03
    	
 
    	
10/27/03
    	
 
    	
0
    	
%
    	
249
    	
 
    	
USL
    	
 
    
	
251
    	
 
    	
 
    	
 
    	
Review   Questionnaire/RFP
    	
 
    	
1 wk
    	
 
    	
10/28/03
    	
 
    	
11/3/03
    	
 
    	
0
    	
%
    	
250
    	
 
    	
USL
    	
 
    
	
252
    	
 
    	
 
    	
 
    	
Send   out Questionnaire/RFP
    	
 
    	
1 wk
    	
 
    	
11/4/03
    	
 
    	
11/10/03
    	
 
    	
0
    	
%
    	
251
    	
 
    	
USL
    	
 
    
	
253
    	
 
    	
 
    	
 
    	
CRO   Responses
    	
 
    	
2 wks
    	
 
    	
11/11/03
    	
 
    	
11/24/03
    	
 
    	
0
    	
%
    	
252
    	
 
    	
USL
    	
 
    
	
254
    	
 
    	
 
    	
 
    	
Review   CRO responses
    	
 
    	
2 wks
    	
 
    	
11/25/03
    	
 
    	
12/8/03
    	
 
    	
0
    	
%
    	
253
    	
 
    	
USL
    	
 
    
	
255
    	
 
    	

    	
 
    	
Audit   CRO
    	
 
    	
1 wk
    	
 
    	
12/9/03
    	
 
    	
12/15/03
    	
 
    	
0
    	
%
    	
254FF
    	
 
    	
USL
    	
 
    
	
256
    	
 
    	
 
    	
 
    	
Select   CRO
    	
 
    	
1 day
    	
 
    	
12/15/03
    	
 
    	
12/15/03
    	
 
    	
0
    	
%
    	
255FF
    	
 
    	
USL
    	
 
    
	
257
    	
 
    	
 
    	
 
    	
CRO   Selection for Transferability
    	
 
    	
46 days
    	
 
    	
10/13/03
    	
 
    	
12/15/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
258
    	
 
    	

    	
 
    	
Identify   potential CROs
    	
 
    	
1 day
    	
 
    	
10/13/03
    	
 
    	
10/13/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
259
    	
 
    	
 
    	
 
    	
Put   CDAs in place
    	
 
    	
1 wk
    	
 
    	
10/14/03
    	
 
    	
10/20/03
    	
 
    	
0
    	
%
    	
258
    	
 
    	
USL
    	
 
    
	
260
    	
 
    	
 
    	
 
    	
Develop   questionnaire/RFP
    	
 
    	
1 wk
    	
 
    	
10/21/03
    	
 
    	
10/27/03
    	
 
    	
0
    	
%
    	
259
    	
 
    	
USL
    	
 
    
	
261
    	
 
    	
 
    	
 
    	
Review   Questionnaire/RFP
    	
 
    	
1 wk
    	
 
    	
10/28/03
    	
 
    	
11/3/03
    	
 
    	
0
    	
%
    	
260
    	
 
    	
USL
    	
 
    
	
262
    	
 
    	
 
    	
 
    	
Send   out Questionnaire/RFP
    	
 
    	
1 wk
    	
 
    	
11/4/03
    	
 
    	
11/10/03
    	
 
    	
0
    	
%
    	
261
    	
 
    	
USL
    	
 
    
	
263
    	
 
    	
 
    	
 
    	
CRO   Responses
    	
 
    	
2 wks
    	
 
    	
11/11/03
    	
 
    	
11/24/03
    	
 
    	
0
    	
%
    	
262
    	
 
    	
USL
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

75

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
264
    	
 
    	
 
    	
 
    	
Review   CRO responses
    	
 
    	
2 wks
    	
 
    	
11/25/03
    	
 
    	
12/8/03
    	
 
    	
0
    	
%
    	
263
    	
 
    	
USL
    	
 
    
	
255
    	
 
    	

    	
 
    	
Audit   CRO
    	
 
    	
1 wk
    	
 
    	
12/9/03
    	
 
    	
12/15/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
266
    	
 
    	
 
    	
 
    	
Select   CRO
    	
 
    	
1 day
    	
 
    	
12/15/03
    	
 
    	
12/15/03
    	
 
    	
0
    	
%
    	
265FF
    	
 
    	
USL
    	
 
    
	
267
    	
 
    	
 
    	
 
    	
CRO   Selection for Washability
    	
 
    	
46 days
    	
 
    	
10/13/03
    	
 
    	
12/15/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
268
    	
 
    	

    	
 
    	
Identify   potential CROs
    	
 
    	
1 day
    	
 
    	
10/13/03
    	
 
    	
10/13/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
269
    	
 
    	
 
    	
 
    	
Put   CDAs in place
    	
 
    	
1 wk
    	
 
    	
10/14/03
    	
 
    	
10/20/03
    	
 
    	
0
    	
%
    	
268
    	
 
    	
USL
    	
 
    
	
270
    	
 
    	
 
    	
 
    	
Develop   questionnaire/RFP
    	
 
    	
1 wk
    	
 
    	
10/21/03
    	
 
    	
10/27/03
    	
 
    	
0
    	
%
    	
269
    	
 
    	
USL
    	
 
    
	
271
    	
 
    	
 
    	
 
    	
Review   Questionnaire/RFP
    	
 
    	
1 wk
    	
 
    	
10/28/03
    	
 
    	
11/3/03
    	
 
    	
0
    	
%
    	
270
    	
 
    	
USL
    	
 
    
	
272
    	
 
    	
 
    	
 
    	
Send   out Questionnaire/RFP
    	
 
    	
1 wk
    	
 
    	
11/4/03
    	
 
    	
11/10/03
    	
 
    	
0
    	
%
    	
271
    	
 
    	
USL
    	
 
    
	
273
    	
 
    	
 
    	
 
    	
CRO   Responses
    	
 
    	
2 wks
    	
 
    	
11/11/03
    	
 
    	
11/24/03
    	
 
    	
0
    	
%
    	
272
    	
 
    	
USL
    	
 
    
	
274
    	
 
    	
 
    	
 
    	
Review   CRO responses
    	
 
    	
2 wks
    	
 
    	
11/25/03
    	
 
    	
12/8/03
    	
 
    	
0
    	
%
    	
273
    	
 
    	
USL
    	
 
    
	
275
    	
 
    	

    	
 
    	
Audit   CRO
    	
 
    	
1 wk
    	
 
    	
12/9/03
    	
 
    	
12/15/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
276
    	
 
    	
 
    	
 
    	
Select   CRO
    	
 
    	
1 day
    	
 
    	
12/15/03
    	
 
    	
12/15/03
    	
 
    	
0
    	
%
    	
275FF
    	
 
    	
USL
    	
 
    
	
277
    	
 
    	
 
    	
 
    	
Contract   Bioanalvtical Lab Selection (Phase I)
    	
 
    	
60 days
    	
 
    	
10/13/03
    	
 
    	
1/15/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
278
    	
 
    	
 
    	
 
    	
Identify   Contract Bioanalytical Laboratories
    	
 
    	
2 wks
    	
 
    	
10/13/03
    	
 
    	
10/24/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
279
    	
 
    	
 
    	
 
    	
Develop   RFP
    	
 
    	
2 wks
    	
 
    	
10/27/03
    	
 
    	
11/7/03
    	
 
    	
0
    	
%
    	
278
    	
 
    	
USL
    	
 
    
	
280
    	
 
    	
 
    	
 
    	
Send   out RFP
    	
 
    	
2 wks
    	
 
    	
11/10/03
    	
 
    	
11/21/03
    	
 
    	
0
    	
%
    	
279
    	
 
    	
USL
    	
 
    
	
281
    	
 
    	
 
    	
 
    	
Review   Proposals
    	
 
    	
3 wks
    	
 
    	
11/24/03
    	
 
    	
12/12/03
    	
 
    	
0
    	
%
    	
280
    	
 
    	
USL
    	
 
    
	
282
    	
 
    	

    	
 
    	
Audit   CRO
    	
 
    	
1 wk
    	
 
    	
12/15/03
    	
 
    	
12/22/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
283
    	
 
    	
 
    	
 
    	
Select   CRO
    	
 
    	
1 day
    	
 
    	
12/19/03
    	
 
    	
12/22/03
    	
 
    	
0
    	
%
    	
282FF
    	
 
    	
USL
    	
 
    
	
284
    	
 
    	
 
    	
 
    	
Letter   of Intent/Contract Negotiations
    	
 
    	
2 wks
    	
 
    	
12/29/03
    	
 
    	
1/15/04
    	
 
    	
0
    	
%
    	
283
    	
 
    	
USL
    	
 
    
	
285
    	
 
    	
 
    	
 
    	
CRO   Selection Clinical Phase III Study
    	
 
    	
66 days
    	
 
    	
10/13/03
    	
 
    	
1/23/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
286
    	
 
    	
 
    	
 
    	
Identify   potential CROs
    	
 
    	
1 day
    	
 
    	
10/13/03
    	
 
    	
10/13/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
287
    	
 
    	
 
    	
 
    	
Put   CDAs In place
    	
 
    	
1 wk
    	
 
    	
10/13/03
    	
 
    	
10/17/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
288
    	
 
    	
 
    	
 
    	
Select   CROs for Web Demonstrations
    	
 
    	
1 wk
    	
 
    	
10/20/03
    	
 
    	
10/24/03
    	
 
    	
0
    	
%
    	
287
    	
 
    	
USL
    	
 
    
	
289
    	
 
    	
 
    	
 
    	
Web   Demonstrations
    	
 
    	
1 wk
    	
 
    	
10/27/03
    	
 
    	
10/31/03
    	
 
    	
0
    	
%
    	
288.287
    	
 
    	
USL
    	
 
    
	
290
    	
 
    	
 
    	
 
    	
Prepare   RFPs
    	
 
    	
2 wks
    	
 
    	
11/3/03
    	
 
    	
11/14/03
    	
 
    	
0
    	
%
    	
289
    	
 
    	
USL
    	
 
    
	
291
    	
 
    	
 
    	
 
    	
Send   out RFPs to 3-4 CROs
    	
 
    	
1 wk
    	
 
    	
11/17/03
    	
 
    	
11/21/03
    	
 
    	
0
    	
%
    	
290
    	
 
    	
USL
    	
 
    
	
292
    	
 
    	

    	
 
    	
CRO   Responses
    	
 
    	
3 wks
    	
 
    	
11/25/03
    	
 
    	
12/15/03
    	
 
    	
0
    	
%
    	
291FF
    	
 
    	
 
    	
 
    
	
293
    	
 
    	

    	
 
    	
Review   Proposals
    	
 
    	
1 wk
    	
 
    	
12/16/03
    	
 
    	
12/29/03
    	
 
    	
0
    	
%
    	
292
    	
 
    	
USL
    	
 
    
	
294
    	
 
    	
 
    	
 
    	
Inhouse   Presentations
    	
 
    	
2 wks
    	
 
    	
1/5/04
    	
 
    	
1/16/04
    	
 
    	
0
    	
%
    	
293
    	
 
    	
USL
    	
 
    
	
295
    	
 
    	
 
    	
 
    	
Audit   CRO
    	
 
    	
1 wk
    	
 
    	
1/19/04
    	
 
    	
1/23/04
    	
 
    	
0
    	
%
    	
294
    	
 
    	
USL
    	
 
    
	
296
    	
 
    	
 
    	
 
    	
Select   CRO
    	
 
    	
1 day
    	
 
    	
1/23/04
    	
 
    	
1/23/04
    	
 
    	
0
    	
%
    	
295FF
    	
 
    	
USL
    	
 
    
	
297
    	
 
    	
 
    	
 
    	
Conduct   Studies
    	
 
    	
564 days
    	
 
    	
10/13/03
    	
 
    	
12/21/05
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
298
    	
 
    	
 
    	
 
    	
PK   Studies (Phase I)
    	
 
    	
239 days
    	
 
    	
12/16/03
    	
 
    	
11/25/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   Lead/Orion Support
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

76

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
299
    	
 
    	
 
    	
 
    	
Protocol   Revisions from FDA
    	
 
    	
3 wks
    	
 
    	
6/2/04
    	
 
    	
6/22/04
    	
 
    	
0
    	
%
    	
209
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
300
    	
 
    	
 
    	
 
    	
Draft   CRFs
    	
 
    	
2 wks
    	
 
    	
1/26/04
    	
 
    	
2/6/04
    	
 
    	
0
    	
%
    	
130
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
301
    	
 
    	
 
    	
 
    	
Review   CRFs
    	
 
    	
2 wks
    	
 
    	
2/9/04
    	
 
    	
2/20/04
    	
 
    	
0
    	
%
    	
300
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
302
    	
 
    	
 
    	
 
    	
Finalize   CRFs
    	
 
    	
1 wk
    	
 
    	
6/23/04
    	
 
    	
6/29/04
    	
 
    	
0
    	
%
    	
299,301
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
303
    	
 
    	
 
    	
 
    	
Pre-study   Site Visit
    	
 
    	
3 wks
    	
 
    	
12/16/03
    	
 
    	
1/16/04
    	
 
    	
0
    	
%
    	
256
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
304
    	
 
    	
 
    	
 
    	
Draft   Informed Consent Document
    	
 
    	
1 wk
    	
 
    	
6/23/04
    	
 
    	
6/29/04
    	
 
    	
0
    	
%
    	
299
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
305
    	
 
    	
 
    	
 
    	
IRB   Submission
    	
 
    	
2 wks
    	
 
    	
6/30/04
    	
 
    	
7/13/04
    	
 
    	
0
    	
%
    	
304
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
306
    	
 
    	
 
    	
 
    	
IRB   Approval
    	
 
    	
2 wks
    	
 
    	
7/14/04
    	
 
    	
7/27/04
    	
 
    	
0
    	
%
    	
305
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
307
    	
 
    	
 
    	
 
    	
Ship   Study Material
    	
 
    	
2 wks
    	
 
    	
7/16/04
    	
 
    	
7/29/04
    	
 
    	
0
    	
%
    	
245,209
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
308
    	
 
    	
 
    	
 
    	
Study   Conduction
    	
 
    	
3 wks
    	
 
    	
7/30/04
    	
 
    	
8/19/04
    	
 
    	
0
    	
%
    	
302,304,306,30
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
309
    	
 
    	
 
    	
 
    	
Ship   Samples to Lab
    	
 
    	
1 wk
    	
 
    	
8/20/04
    	
 
    	
8/26/04
    	
 
    	
0
    	
%
    	
308
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
310
    	
 
    	
 
    	
 
    	
Sample   Analysis
    	
 
    	
4 wks
    	
 
    	
8/27/04
    	
 
    	
9/23/04
    	
 
    	
0
    	
%
    	
309
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
311
    	
 
    	
 
    	
 
    	
Preliminary   Statistical Results
    	
 
    	
1 wk
    	
 
    	
9/24/04
    	
 
    	
9/30/04
    	
 
    	
0
    	
%
    	
310
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
312
    	
 
    	
 
    	
 
    	
Draft   Report
    	
 
    	
4 wks
    	
 
    	
10/1/04
    	
 
    	
10/28/04
    	
 
    	
0
    	
%
    	
311
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
313
    	
 
    	
 
    	
 
    	
USL   review of Draft Report
    	
 
    	
2 wks
    	
 
    	
10/29/04
    	
 
    	
11/11/04
    	
 
    	
0
    	
%
    	
312
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
314
    	
 
    	
 
    	
 
    	
Final   Report
    	
 
    	
2 wks
    	
 
    	
11/12/04
    	
 
    	
11/25/04
    	
 
    	
0
    	
%
    	
313
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
315
    	
 
    	
 
    	
 
    	
Transferability   Studies (Phase I)
    	
 
    	
300 days
    	
 
    	
10/13/03
    	
 
    	
12/16/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
316
    	
 
    	
 
    	
 
    	
Protocol   Revisions from FDA
    	
 
    	
3 wks
    	
 
    	
6/2/04
    	
 
    	
6/22/04
    	
 
    	
0
    	
%
    	
209
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
317
    	
 
    	
 
    	
 
    	
Draft   CRFs
    	
 
    	
2 wks
    	
 
    	
12/8/03
    	
 
    	
12/19/03
    	
 
    	
0
    	
%
    	
135
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
318
    	
 
    	
 
    	
 
    	
Review   CRFs
    	
 
    	
2 wks
    	
 
    	
12/29/03
    	
 
    	
1/15/04
    	
 
    	
0
    	
%
    	
317
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
319
    	
 
    	
 
    	
 
    	
Finalize   CRFs
    	
 
    	
1 wk
    	
 
    	
6/23/04
    	
 
    	
6/29/04
    	
 
    	
0
    	
%
    	
316,318
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
320
    	
 
    	
 
    	
 
    	
Pre-study   Site Visit
    	
 
    	
3 wks
    	
 
    	
10/13/03
    	
 
    	
10/31/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
321
    	
 
    	
 
    	
 
    	
Draft   Informed Consent Document
    	
 
    	
1 wk
    	
 
    	
6/23/04
    	
 
    	
6/29/04
    	
 
    	
0
    	
%
    	
316
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
322
    	
 
    	
 
    	
 
    	
IRB   Submission
    	
 
    	
2 wks
    	
 
    	
6/30/04
    	
 
    	
7/13/04
    	
 
    	
0
    	
%
    	
321
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
323
    	
 
    	
 
    	
 
    	
IRB   Approval
    	
 
    	
2 wks
    	
 
    	
7/14/04
    	
 
    	
7/27/04
    	
 
    	
0
    	
%
    	
322
    	
 
    	
USL   Load/Orion Support
    	
 
    
	
324
    	
 
    	
 
    	
 
    	
Ship   Study Material
    	
 
    	
2 wks
    	
 
    	
7/16/04
    	
 
    	
7/29/04
    	
 
    	
0
    	
%
    	
245,209
    	
 
    	
USL   Load/Orion Support
    	
 
    
	
325
    	
 
    	
 
    	
 
    	
Study   Conduction
    	
 
    	
6 wks
    	
 
    	
7/30/04
    	
 
    	
9/9/04
    	
 
    	
0
    	
%
    	
319,321,323,32
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
326
    	
 
    	
 
    	
 
    	
Ship   Samples to Lab
    	
 
    	
1 wk
    	
 
    	
9/10/04
    	
 
    	
9/16/04
    	
 
    	
0
    	
%
    	
325
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
327
    	
 
    	
 
    	
 
    	
Sample   Analysis
    	
 
    	
4 wks
    	
 
    	
9/17/04
    	
 
    	
10/14/04
    	
 
    	
0
    	
%
    	
326
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
328
    	
 
    	
 
    	
 
    	
Preliminary   Statistical Results
    	
 
    	
1 wk
    	
 
    	
10/15/04
    	
 
    	
10/21/04
    	
 
    	
0
    	
%
    	
327
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
329
    	
 
    	
 
    	
 
    	
Draft   Report
    	
 
    	
4 wks
    	
 
    	
10/22/04
    	
 
    	
11/18/04
    	
 
    	
0
    	
%
    	
328
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
330
    	
 
    	
 
    	
 
    	
USL   review of Draft Report
    	
 
    	
2 wks
    	
 
    	
11/19/04
    	
 
    	
12/2/04
    	
 
    	
0
    	
%
    	
329
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
331
    	
 
    	
 
    	
 
    	
Final   Report
    	
 
    	
2 wks
    	
 
    	
12/3/04
    	
 
    	
12/16/04
    	
 
    	
0
    	
%
    	
330
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
332
    	
 
    	
 
    	
 
    	
Washability   studies (Phase I)
    	
 
    	
285 days
    	
 
    	
10/13/03
    	
 
    	
11/25/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
333
    	
 
    	
 
    	
 
    	
Protocol   Revisions from FDA
    	
 
    	
3 wks
    	
 
    	
6/2/04
    	
 
    	
6/22/04
    	
 
    	
0
    	
%
    	
209
    	
 
    	
USL   Lead/Orion Support
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

77

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
334
    	
 
    	
 
    	
 
    	
Draft   CRFs
    	
 
    	
2 wks
    	
 
    	
12/8/03
    	
 
    	
12/19/03
    	
 
    	
0
    	
%
    	
140
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
335
    	
 
    	
 
    	
 
    	
Review   CRFs
    	
 
    	
2 wks
    	
 
    	
12/29/03
    	
 
    	
1/15/04
    	
 
    	
0
    	
%
    	
334
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
336
    	
 
    	
 
    	
 
    	
Finalize   CRFs
    	
 
    	
1 wk
    	
 
    	
6/23/04
    	
 
    	
6/29/04
    	
 
    	
0
    	
%
    	
333,335
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
337
    	
 
    	
 
    	
 
    	
Pre-study   Site Visit
    	
 
    	
3 wks
    	
 
    	
10/13/03
    	
 
    	
10/31/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
338
    	
 
    	
 
    	
 
    	
Draft   Informed Consent Document
    	
 
    	
1 wk
    	
 
    	
6/23/04
    	
 
    	
6/29/04
    	
 
    	
0
    	
%
    	
333
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
339
    	
 
    	
 
    	
 
    	
IRB   Submission
    	
 
    	
2 wks
    	
 
    	
6/30/04
    	
 
    	
7/13/04
    	
 
    	
0
    	
%
    	
338
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
340
    	
 
    	
 
    	
 
    	
IRB   Approval
    	
 
    	
2 wks
    	
 
    	
7/14/04
    	
 
    	
7/27/04
    	
 
    	
0
    	
%
    	
339
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
341
    	
 
    	
 
    	
 
    	
Ship   Study Material
    	
 
    	
2 wks
    	
 
    	
7/16/04
    	
 
    	
7/29/04
    	
 
    	
0
    	
%
    	
245,209
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
342
    	
 
    	
 
    	
 
    	
Study   Conduction
    	
 
    	
3 wks
    	
 
    	
7/30/04
    	
 
    	
8/19/04
    	
 
    	
0
    	
%
    	
336,338,340,34
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
343
    	
 
    	
 
    	
 
    	
Ship   Samples to Lab
    	
 
    	
1 wk
    	
 
    	
8/20/04
    	
 
    	
8/26/04
    	
 
    	
0
    	
%
    	
342
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
344
    	
 
    	
 
    	
 
    	
Sample   Analysis
    	
 
    	
4 wks
    	
 
    	
8/27/04
    	
 
    	
9/23/04
    	
 
    	
0
    	
%
    	
343
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
345
    	
 
    	
 
    	
 
    	
Preliminary   Statistical Results
    	
 
    	
1 wk
    	
 
    	
9/24/04
    	
 
    	
9/30/04
    	
 
    	
0
    	
%
    	
344
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
346
    	
 
    	
 
    	
 
    	
Draft   Report
    	
 
    	
4 wks
    	
 
    	
10/1/04
    	
 
    	
10/28/04
    	
 
    	
0
    	
%
    	
345
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
347
    	
 
    	
 
    	
 
    	
USL   review of Draft Report
    	
 
    	
2 wks
    	
 
    	
10/29/04
    	
 
    	
11/11/04
    	
 
    	
0
    	
%
    	
346
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
348
    	
 
    	
 
    	
 
    	
Final   Report
    	
 
    	
2 wks
    	
 
    	
11/12/04
    	
 
    	
11/25/04
    	
 
    	
0
    	
%
    	
347
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
349
    	
 
    	
 
    	
 
    	
Conduct   Clinical Phase III Study
    	
 
    	
498 days
    	
 
    	
1/26/04
    	
 
    	
12/21/05
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
350
    	
 
    	
 
    	
 
    	
Protocol   Revisions from FDA
    	
 
    	
4 wks
    	
 
    	
6/24/04
    	
 
    	
7/21/04
    	
 
    	
0
    	
%
    	
209,212
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
351
    	
 
    	
 
    	
 
    	
Revise   CRFs per FDA changes
    	
 
    	
4 wks
    	
 
    	
7/8/04
    	
 
    	
8/4/04
    	
 
    	
0
    	
%
    	
350FS-2   wks
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
352
    	
 
    	
 
    	
 
    	
Review   CRFs
    	
 
    	
2 wks
    	
 
    	
8/5/04
    	
 
    	
8/18/04
    	
 
    	
0
    	
%
    	
351
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
353
    	
 
    	
 
    	
 
    	
Finalize   CRFs
    	
 
    	
1 wk
    	
 
    	
8/19/04
    	
 
    	
8/25/04
    	
 
    	
0
    	
%
    	
352
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
354
    	
 
    	
 
    	
 
    	
Print   CRFs
    	
 
    	
4 wks
    	
 
    	
8/26/04
    	
 
    	
9/22/04
    	
 
    	
0
    	
%
    	
353
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
355
    	
 
    	
 
    	
 
    	
Identify   Investigators
    	
 
    	
4 wks
    	
 
    	
1/26/04
    	
 
    	
2/20/04
    	
 
    	
0
    	
%
    	
296
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
356
    	
 
    	
 
    	
 
    	
Pre-study   Site Visit
    	
 
    	
4 wks
    	
 
    	
2/23/04
    	
 
    	
3/19/04
    	
 
    	
0
    	
%
    	
355
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
357
    	
 
    	
 
    	
 
    	
Select   Investigators
    	
 
    	
2 wks
    	
 
    	
3/22/04
    	
 
    	
4/2/04
    	
 
    	
0
    	
%
    	
356
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
358
    	
 
    	
 
    	
 
    	
Investigators   Meeting
    	
 
    	
2 wks
    	
 
    	
4/5/04
    	
 
    	
4/16/04
    	
 
    	
0
    	
%
    	
357
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
359
    	
 
    	
 
    	
 
    	
Arrange   Lab Kits
    	
 
    	
4 wks
    	
 
    	
7/22/04
    	
 
    	
8/18/04
    	
 
    	
0
    	
%
    	
350
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
360
    	
 
    	
 
    	
 
    	
Send   Lab Kits to Sites
    	
 
    	
3 wks
    	
 
    	
8/19/04
    	
 
    	
9/8/04
    	
 
    	
0
    	
%
    	
359
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
361
    	
 
    	
 
    	
 
    	
Draft   Informed Consent Document
    	
 
    	
1 wk
    	
 
    	
7/22/04
    	
 
    	
7/28/04
    	
 
    	
0
    	
%
    	
350,357
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
362
    	
 
    	
 
    	
 
    	
IRB   Submissions
    	
 
    	
2 wks
    	
 
    	
7/29/04
    	
 
    	
8/11/04
    	
 
    	
0
    	
%
    	
357,361
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
363
    	
 
    	
 
    	
 
    	
IRB   Approvals
    	
 
    	
4 wks
    	
 
    	
8/12/04
    	
 
    	
9/8/04
    	
 
    	
0
    	
%
    	
362
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
364
    	
 
    	
 
    	
 
    	
Ship   Study Materials
    	
 
    	
2 wks
    	
 
    	
9/23/04
    	
 
    	
10/6/04
    	
 
    	
0
    	
%
    	
363FS-2   wks,35
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
365
    	
 
    	
 
    	
 
    	
Study   Initiation Visits
    	
 
    	
4 wks
    	
 
    	
10/7/04
    	
 
    	
11/3/04
    	
 
    	
0
    	
%
    	
364
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
366
    	
 
    	
 
    	
 
    	
Enroll   First Study Subjects
    	
 
    	
2 wks
    	
 
    	
10/7/04
    	
 
    	
10/20/04
    	
 
    	
0
    	
%
    	
365SSS
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
367
    	
 
    	
 
    	
 
    	
Monitor   Study
    	
 
    	
6 mons
    	
 
    	
11/4/04
    	
 
    	
4/20/05
    	
 
    	
0
    	
%
    	
366SS+4   wks
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
368
    	
 
    	
 
    	
 
    	
Last   Study Patient enrolled
    	
 
    	
1 day
    	
 
    	
4/21/05
    	
 
    	
4/21/05
    	
 
    	
0
    	
%
    	
367
    	
 
    	
USL   Lead/Orion Support
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

78

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
369
    	
 
    	
 
    	
 
    	
Last Patient Complete Study
    	
 
    	
12 wks
    	
 
    	
4/22/05
    	
 
    	
7/14/05
    	
 
    	
0
    	
%
    	
368
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
370
    	
 
    	

    	
 
    	
Data Entry
    	
 
    	
4 wks
    	
 
    	
7/15/05
    	
 
    	
8/11/05
    	
 
    	
0
    	
%
    	
369
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
371
    	
 
    	
 
    	
 
    	
Database Lock
    	
 
    	
4 wks
    	
 
    	
8/12/05
    	
 
    	
9/8/05
    	
 
    	
0
    	
%
    	
370
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
372
    	
 
    	
 
    	
 
    	
Preliminary Statistical Results
    	
 
    	
4 wks
    	
 
    	
9/9/05
    	
 
    	
10/6/05
    	
 
    	
0
    	
%
    	
371
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
373
    	
 
    	
 
    	
 
    	
Draft Report
    	
 
    	
4 wks
    	
 
    	
10/7/05
    	
 
    	
11/3/05
    	
 
    	
0
    	
%
    	
372
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
374
    	
 
    	
 
    	
 
    	
USL review of Draft Report
    	
 
    	
4 wks
    	
 
    	
11/4/05
    	
 
    	
12/1/05
    	
 
    	
0
    	
%
    	
373
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
375
    	
 
    	
 
    	
 
    	
Final Report
    	
 
    	
2 wks
    	
 
    	
12/2/05
    	
 
    	
12/15/05
    	
 
    	
0
    	
%
    	
374
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
376
    	
 
    	
 
    	
 
    	
Phase III Reports to USL
    	
 
    	
3 days
    	
 
    	
12/16/05
    	
 
    	
12/20/05
    	
 
    	
0
    	
%
    	
375
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
377
    	
 
    	
 
    	
 
    	
Reports to RA
    	
 
    	
1 day
    	
 
    	
12/21/05
    	
 
    	
12/21/05
    	
 
    	
0
    	
%
    	
376
    	
 
    	
USL   Lead/Orion Support
    	
 
    
	
378
    	
 
    	
 
    	
 
    	
FDA Pre-NDA Meeting
    	
 
    	
61 days
    	
 
    	
7/15/05
    	
 
    	
10/7/05
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
379
    	
 
    	
 
    	
 
    	
Request Meeting
    	
 
    	
1 day
    	
 
    	
7/15/05
    	
 
    	
7/15/05
    	
 
    	
0
    	
%
    	
369
    	
 
    	
USL
    	
 
    
	
380
    	
 
    	
 
    	
 
    	
Conduct Meeting
    	
 
    	
60 days
    	
 
    	
7/18/05
    	
 
    	
10/7/05
    	
 
    	
0
    	
%
    	
379
    	
 
    	
USL
    	
 
    
	
381
    	
 
    	
 
    	
 
    	
NDA Preparation and Review
    	
 
    	
539 days
    	
 
    	
6/2/04
    	
 
    	
6/26/06
    	
 
    	
0
    	
%
    	
209
    	
 
    	
 
    	
 
    
	
382
    	
 
    	
 
    	
 
    	
CMC Tasks - Prep
    	
 
    	
288 days
    	
 
    	
6/2/04
    	
 
    	
7/8/05
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
383
    	
 
    	
 
    	
 
    	
FDA API specifications
    	
 
    	
15 days
    	
 
    	
6/2/04
    	
 
    	
6/22/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
384
    	
 
    	
 
    	
 
    	
Address FDA directive relative to API specifications see note 14
    	
 
    	
3 wks
    	
 
    	
6/2/04
    	
 
    	
6/22/04
    	
 
    	
0
    	
%
    	
209
    	
 
    	
USL
    	
 
    
	
385
    	
 
    	
 
    	
 
    	
Update release data from stability, tox, and clinical DS lots using   US guidelines
    	
 
    	
10 days
    	
 
    	
6/2/04
    	
 
    	
6/15/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
386
    	
 
    	
 
    	
 
    	
Method   Numbers, Specifications limits, Dates assayed, Location where DS lots were   used for a given lot of DP which lots of DS were used, (reference to DP lots   made from DS batches)
    	
 
    	
2 wks
    	
 
    	
6/2/04
    	
 
    	
6/15/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
387
    	
 
    	
 
    	
 
    	
Drug Product Manufacturing
    	
 
    	
20 days
    	
 
    	
6/2/04
    	
 
    	
6/29/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
388
    	
 
    	
 
    	
 
    	
Confirm studies performed to evaluate sealing temperature ranges
    	
 
    	
4 wks
    	
 
    	
6/2/04
    	
 
    	
6/29/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
389
    	
 
    	
 
    	
 
    	
Address   cleaning validation: ensure analytical method validation is complete; perform   validation for manufacturing equipment cleaning process
    	
 
    	
2 days
    	
 
    	
6/2/04
    	
 
    	
6/3/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
390
    	
 
    	
 
    	
 
    	
Drug Product Specifications
    	
 
    	
40 days
    	
 
    	
6/2/04
    	
 
    	
7/27/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
391
    	
 
    	
 
    	
 
    	
Transfer ID test method to USL
    	
 
    	
8 wks
    	
 
    	
6/2/04
    	
 
    	
7/27/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   ORION
    	
 
    
	
392
    	
 
    	
 
    	
 
    	
Establish USL specifications for receipt of incoming labeled finished   product
    	
 
    	
4 wks
    	
 
    	
6/2/04
    	
 
    	
6/29/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
393
    	
 
    	
 
    	
 
    	
DP Container/Closure
    	
 
    	
113 days
    	
 
    	
6/2/04
    	
 
    	
11/5/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
394
    	
 
    	

    	
 
    	
Perform   and provide report on new leachables/extractables study if given directive by   FDA
    	
 
    	
8 wks
    	
 
    	
9/13/04
    	
 
    	
11/5/04
    	
 
    	
0
    	
%
    	
230
    	
 
    	
Orion
    	
 
    
	
395
    	
 
    	
 
    	
 
    	
Provide   history of laminates: current versus those used in stability batches, ELI,   ELIIA, ELIIB, etc, Short History of one paragraph to be Included in the   Product development summary for IND submission
    	
 
    	
8 wks
    	
 
    	
6/2/04
    	
 
    	
7/27/04
    	
 
    	
0
    	
%
    	
209
    	
 
    	
Orion
    	
 
    
	
396
    	
 
    	
 
    	
 
    	
DP Stability
    	
 
    	
20 days
    	
 
    	
6/13/05
    	
 
    	
7/8/05
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

79

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
397
    	
 
    	
 
    	
 
    	
Update   stability reports - need data requirements
    	
 
    	
4 wks
    	
 
    	
6/13/05
    	
 
    	
7/8/05
    	
 
    	
0
    	
%
    	
215,221
    	
 
    	
Orion
    	
 
    
	
398
    	
 
    	
 
    	
 
    	
Process   validation
    	
 
    	
50 days
    	
 
    	
6/2/04
    	
 
    	
8/10/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
399
    	
 
    	

    	
 
    	
Review   available EF-108 ValidationData in IIB laminate
    	
 
    	
2 wks
    	
 
    	
6/2/04
    	
 
    	
6/15/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   GR
    	
 
    
	
400
    	
 
    	

    	
 
    	
Two   development batches need to be made to support EF-108 formulation as follows:   See Notes May need to include 0.25 dosage
    	
 
    	
10 wks
    	
 
    	
6/2/04
    	
 
    	
8/10/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion
    	
 
    
	
401
    	
 
    	
 
    	
 
    	
Weight   checker system (sachet weigher) validated, including 0.25 g fill volume
    	
 
    	
1 wk
    	
 
    	
6/2/04
    	
 
    	
6/8/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
402
    	
 
    	
 
    	
 
    	
Environmental   Exclusive Assessment
    	
 
    	
120 days
    	
 
    	
6/2/04
    	
 
    	
11/16/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
Orion?
    	
 
    
	
403
    	
 
    	
 
    	
 
    	
Conduct   Assessment
    	
 
    	
6 mons
    	
 
    	
6/2/04
    	
 
    	
11/16/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
404
    	
 
    	
 
    	
 
    	
NDA   Document Prep
    	
 
    	
539 days
    	
 
    	
6/2/04
    	
 
    	
6/26/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
405
    	
 
    	
 
    	
 
    	
Overall   CTD Table of Contents (2.1)
    	
 
    	
3 days
    	
 
    	
6/2/04
    	
 
    	
6/4/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
406
    	
 
    	
 
    	
 
    	
Introduction   to the Summary documents (one page) (2.2)
    	
 
    	
1 wk
    	
 
    	
6/2/04
    	
 
    	
6/8/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
407
    	
 
    	
 
    	
 
    	
Quality   Overall Summary 2.3
    	
 
    	
10 days
    	
 
    	
12/12/05
    	
 
    	
12/23/05
    	
 
    	
0
    	
%
    	
214,472
    	
 
    	
USL
    	
 
    
	
408
    	
 
    	
 
    	
 
    	
Drug   Substance
    	
 
    	
2 wks
    	
 
    	
12/12/05
    	
 
    	
12/23/05
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
409
    	
 
    	
 
    	
 
    	
Drug   Product
    	
 
    	
2 wks
    	
 
    	
12/12/05
    	
 
    	
12/23/05
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
410
    	
 
    	
 
    	
 
    	
Nonclinical   Overview (2.4)
    	
 
    	
2 days
    	
 
    	
6/2/04
    	
 
    	
6/3/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
411
    	
 
    	
 
    	
 
    	
Pharmacology
    	
 
    	
2 days
    	
 
    	
6/2/04
    	
 
    	
6/3/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
412
    	
 
    	
 
    	
 
    	
Pharmacokinetics
    	
 
    	
2 days
    	
 
    	
6/2/04
    	
 
    	
6/3/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
413
    	
 
    	
 
    	
 
    	
Toxicology
    	
 
    	
2 days
    	
 
    	
6/2/04
    	
 
    	
6/3/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
414
    	
 
    	
 
    	
 
    	
Integrated   Overview and Conclusions
    	
 
    	
2 days
    	
 
    	
6/2/04
    	
 
    	
6/3/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
415
    	
 
    	
 
    	
 
    	
List   of Literature Citations
    	
 
    	
2 days
    	
 
    	
6/2/04
    	
 
    	
6/3/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
416
    	
 
    	
 
    	
 
    	
Clinical   Overview (2.5)
    	
 
    	
56 days
    	
 
    	
12/7/05
    	
 
    	
2/22/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
417
    	
 
    	
 
    	
 
    	
Product   Development Rationale
    	
 
    	
2 wks
    	
 
    	
12/7/05
    	
 
    	
12/20/05
    	
 
    	
0
    	
%
    	
490FF-2   mons
    	
 
    	
USL
    	
 
    
	
418
    	
 
    	
 
    	
 
    	
Overview   of Biopharmaceutics
    	
 
    	
2 wks
    	
 
    	
12/7/05
    	
 
    	
12/20/05
    	
 
    	
0
    	
%
    	
490FF-2   mons
    	
 
    	
USL
    	
 
    
	
419
    	
 
    	
 
    	
 
    	
Overview   of Clinical Pharmacology
    	
 
    	
1 day
    	
 
    	
12/20/05
    	
 
    	
12/20/05
    	
 
    	
0
    	
%
    	
490FF-2   mons
    	
 
    	
USL
    	
 
    
	
420
    	
 
    	
 
    	
 
    	
Pharmacokinetics
    	
 
    	
2 wks
    	
 
    	
1/25/06
    	
 
    	
2/7/06
    	
 
    	
0
    	
%
    	
445
    	
 
    	
USL
    	
 
    
	
421
    	
 
    	
 
    	
 
    	
Pharmacodynamics
    	
 
    	
2 wks
    	
 
    	
1/25/06
    	
 
    	
2/7/06
    	
 
    	
0
    	
%
    	
445
    	
 
    	
USL
    	
 
    
	
422
    	
 
    	
 
    	
 
    	
Overview   of Efficacy
    	
 
    	
2 wks
    	
 
    	
1/26/06
    	
 
    	
2/8/06
    	
 
    	
0
    	
%
    	
437
    	
 
    	
USL
    	
 
    
	
423
    	
 
    	
 
    	
 
    	
Overview   of Safety
    	
 
    	
2 wks
    	
 
    	
1/26/06
    	
 
    	
2/8/06
    	
 
    	
0
    	
%
    	
438
    	
 
    	
USL
    	
 
    
	
424
    	
 
    	
 
    	
 
    	
Benefits   and Risk Conclusions
    	
 
    	
2 wks
    	
 
    	
2/9/06
    	
 
    	
2/22/06
    	
 
    	
0
    	
%
    	
422,423
    	
 
    	
USL
    	
 
    
	
425
    	
 
    	
 
    	
 
    	
References
    	
 
    	
2 wks
    	
 
    	
12/7/05
    	
 
    	
12/20/05
    	
 
    	
0
    	
%
    	
490FF-2   mons
    	
 
    	
USL
    	
 
    
	
426
    	
 
    	
 
    	
 
    	
Nonclinical   Written and Tabulated Summaries (2.6)
    	
 
    	
40 days
    	
 
    	
11/23/05
    	
 
    	
1/17/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
427
    	
 
    	
 
    	
 
    	
Introduction
    	
 
    	
8 wks
    	
 
    	
11/23/05
    	
 
    	
1/17/06
    	
 
    	
0
    	
%
    	
490FF-1   mon
    	
 
    	
USL
    	
 
    
	
428
    	
 
    	
 
    	
 
    	
Pharmacology   Written Summary
    	
 
    	
8 wks
    	
 
    	
11/23/05
    	
 
    	
1/17/06
    	
 
    	
0
    	
%
    	
490FF-1   mon
    	
 
    	
USL
    	
 
    
	
429
    	
 
    	
 
    	
 
    	
Pharmacology   Tabulated Summary
    	
 
    	
8 wks
    	
 
    	
11/23/05
    	
 
    	
1/17/06
    	
 
    	
0
    	
%
    	
490FF-1   mon
    	
 
    	
USL
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

80

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline -Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
430
    	
 
    	
 
    	
 
    	
Pharmacokinetics   Written Summary
    	
 
    	
8   wks
    	
 
    	
11/23/05
    	
 
    	
1/17/06
    	
 
    	
0
    	
%
    	
490FF-1 mon
    	
 
    	
USL
    	
 
    
	
431
    	
 
    	
 
    	
 
    	
Pharmacokinetics   Tabulated Summary
    	
 
    	
8   wks
    	
 
    	
11/23/05
    	
 
    	
1/17/06
    	
 
    	
0
    	
%
    	
490FF-1 mon
    	
 
    	
USL
    	
 
    
	
432
    	
 
    	
 
    	
 
    	
Toxicology   Written Summary
    	
 
    	
8   wks
    	
 
    	
11/23/05
    	
 
    	
1/17/06
    	
 
    	
0
    	
%
    	
490FF-1 mon
    	
 
    	
USL
    	
 
    
	
433
    	
 
    	
 
    	
 
    	
Toxicology   Tabulated Summary
    	
 
    	
8   wks
    	
 
    	
11/23/05
    	
 
    	
1/17/06
    	
 
    	
0
    	
%
    	
490FF-1 mon
    	
 
    	
USL
    	
 
    
	
434
    	
 
    	
 
    	
 
    	
Clinical   Summary (2.7)
    	
 
    	
25   days
    	
 
    	
12/22/05
    	
 
    	
1/25/06
    	
 
    	
0
    	
%
    	
298,315,332,345
    	
 
    	
USL
    	
 
    
	
435
    	
 
    	
 
    	
 
    	
Summary   of Biopharmaceutic Studies and Associated Analytical Methods
    	
 
    	
5   wks
    	
 
    	
12/22/05
    	
 
    	
1/25/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
436
    	
 
    	
 
    	
 
    	
Clinical   Pharmacology Studies
    	
 
    	
5   wks
    	
 
    	
12/22/05
    	
 
    	
1/25/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
437
    	
 
    	
 
    	
 
    	
Summary   of Clinical Efficacy
    	
 
    	
5   wks
    	
 
    	
12/22/05
    	
 
    	
1/25/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
438
    	
 
    	
 
    	
 
    	
Summary   of Clinical Safety
    	
 
    	
5   wks
    	
 
    	
12/22/05
    	
 
    	
1/25/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
439
    	
 
    	
 
    	
 
    	
References
    	
 
    	
5   wks
    	
 
    	
12/22/05
    	
 
    	
1/25/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
440
    	
 
    	
 
    	
 
    	
Synopsis   of Individual Studies
    	
 
    	
5   wks
    	
 
    	
12/22/05
    	
 
    	
1/25/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
441
    	
 
    	
 
    	
 
    	
Non Clinical Study Reports (Module 4)
    	
 
    	
20   days
    	
 
    	
1/18/06
    	
 
    	
2/14/06
    	
 
    	
0
    	
%
    	
426
    	
 
    	
USL
    	
 
    
	
442
    	
 
    	
 
    	
 
    	
Table   of Contents
    	
 
    	
2   days
    	
 
    	
1/18/06
    	
 
    	
1/19/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
443
    	
 
    	
 
    	
 
    	
Study   Reports
    	
 
    	
5   days
    	
 
    	
1/18/06
    	
 
    	
1/24/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
444
    	
 
    	
 
    	
 
    	
Pharmacology
    	
 
    	
1   wk
    	
 
    	
1/18/06
    	
 
    	
1/24/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
445
    	
 
    	
 
    	
 
    	
Pharmacokinetics
    	
 
    	
1   wk
    	
 
    	
1/18/06
    	
 
    	
1/24/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
446
    	
 
    	
 
    	
 
    	
Toxicology
    	
 
    	
1   wk
    	
 
    	
1/18/06
    	
 
    	
1/24/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
447
    	
 
    	
 
    	
 
    	
Literature   References
    	
 
    	
4   wks
    	
 
    	
1/18/06
    	
 
    	
2/14/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
448
    	
 
    	
 
    	
 
    	
Clinical Study Reports (Module 5)
    	
 
    	
120   days
    	
 
    	
8/3/05
    	
 
    	
1/17/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
449
    	
 
    	
 
    	
 
    	
Table   of Contents
    	
 
    	
6   mons
    	
 
    	
8/3/05
    	
 
    	
1/17/06
    	
 
    	
0
    	
%
    	
377SS-5 mons
    	
 
    	
USL
    	
 
    
	
450
    	
 
    	
 
    	
 
    	
Tabular   Listing of all Clinical Studies
    	
 
    	
6   mons
    	
 
    	
8/3/05
    	
 
    	
1/17/06
    	
 
    	
0
    	
%
    	
449FF
    	
 
    	
USL
    	
 
    
	
451
    	
 
    	
 
    	
 
    	
Study   Reports and Related Information
    	
 
    	
6   mons
    	
 
    	
8/3/05
    	
 
    	
1/17/06
    	
 
    	
0
    	
%
    	
449FF
    	
 
    	
USL
    	
 
    
	
452
    	
 
    	
 
    	
 
    	
Literature   References
    	
 
    	
6   mons
    	
 
    	
8/3/05
    	
 
    	
1/17/06
    	
 
    	
0
    	
%
    	
449FF
    	
 
    	
USL
    	
 
    
	
453
    	
 
    	
 
    	
 
    	
Labeling
    	
 
    	
397   days
    	
 
    	
12/17/04
    	
 
    	
6/26/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL Lead/Orion Support
    	
 
    
	
454
    	
 
    	
 
    	
 
    	
Draft   PI
    	
 
    	
16   wks
    	
 
    	
12/17/04
    	
 
    	
4/7/05
    	
 
    	
0
    	
%
    	
314,331,348
    	
 
    	
 
    	
 
    
	
455
    	
 
    	
 
    	
 
    	
Revise   PI Labeling with Clinical Data
    	
 
    	
4   wks
    	
 
    	
2/14/06
    	
 
    	
3/13/06
    	
 
    	
0
    	
%
    	
480
    	
 
    	
USL Lead/Orion Support
    	
 
    
	
456
    	
 
    	
 
    	
 
    	
Finalize   PI on Disk
    	
 
    	
4   wks
    	
 
    	
3/14/06
    	
 
    	
4/10/06
    	
 
    	
0
    	
%
    	
455
    	
 
    	
USL Lead/Orion Support
    	
 
    
	
457
    	
 
    	
 
    	
 
    	
Dev.   Final Draft Labeling PI and labels/cartons
    	
 
    	
8   wks
    	
 
    	
3/14/06
    	
 
    	
5/8/06
    	
 
    	
0
    	
%
    	
455
    	
 
    	
USL Lead/Orion Support
    	
 
    
	
458
    	
 
    	
 
    	
 
    	
Approve   Labeling
    	
 
    	
3   wks
    	
 
    	
5/9/06
    	
 
    	
5/29/06
    	
 
    	
0
    	
%
    	
457
    	
 
    	
USL Lead/Orion Support
    	
 
    
	
459
    	
 
    	
 
    	
 
    	
Label   Specifications
    	
 
    	
2   wks
    	
 
    	
5/30/06
    	
 
    	
6/12/06
    	
 
    	
0
    	
%
    	
458
    	
 
    	
USL Lead/Orion Support
    	
 
    
	
460
    	
 
    	
 
    	
 
    	
Order   Final Draft Labeling (printer’s proofs)
    	
 
    	
2   wks
    	
 
    	
6/13/06
    	
 
    	
6/26/06
    	
 
    	
0
    	
%
    	
457,458,459
    	
 
    	
USL Lead/Orion Support
    	
 
    
	
461
    	
 
    	
 
    	
 
    	
NDA   CMC Document Prep
    	
 
    	
135   days
    	
 
    	
7/11/05
    	
 
    	
1/13/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
462
    	
 
    	
 
    	
 
    	
Provide   new/additional data per project plan (in hard copy and electronically, where   possible)
    	
 
    	
3   wks
    	
 
    	
7/11/05
    	
 
    	
7/29/05
    	
 
    	
0
    	
%
    	
382
    	
 
    	
Orion
    	
 
    
	
463
    	
 
    	
 
    	
 
    	
Update   CMC with additional data and detail
    	
 
    	
6   wks
    	
 
    	
8/1/05
    	
 
    	
9/9/05
    	
 
    	
0
    	
%
    	
462
    	
 
    	
USL DR
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

81

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
464
    	
 
    	
 
    	
 
    	
Request   additional details
    	
 
    	
6 wks
    	
 
    	
8/1/05
    	
 
    	
9/9/05
    	
 
    	
0
    	
%
    	
463FF
    	
 
    	
USL   DR
    	
 
    
	
465
    	
 
    	
 
    	
 
    	
Provide   additional details
    	
 
    	
3 wks
    	
 
    	
9/12/05
    	
 
    	
9/30/05
    	
 
    	
0
    	
%
    	
463
    	
 
    	
Orion
    	
 
    
	
466
    	
 
    	
 
    	
 
    	
Provide   1st draft CMC for review
    	
 
    	
0 wks
    	
 
    	
9/30/05
    	
 
    	
9/30/05
    	
 
    	
0
    	
%
    	
465
    	
 
    	
USL   DR
    	
 
    
	
467
    	
 
    	
 
    	
 
    	
Review   CMC 1st draft
    	
 
    	
2 wks
    	
 
    	
10/3/05
    	
 
    	
10/14/05
    	
 
    	
0
    	
%
    	
466
    	
 
    	
Orion   USL
    	
 
    
	
468
    	
 
    	
 
    	
 
    	
Make   revisions to CMC 1st draft
    	
 
    	
2 wks
    	
 
    	
10/17/05
    	
 
    	
10/28/05
    	
 
    	
0
    	
%
    	
467
    	
 
    	
USL   DR
    	
 
    
	
469
    	
 
    	
 
    	
 
    	
Provide   2nd draft CMC for review
    	
 
    	
0 wks
    	
 
    	
10/28/05
    	
 
    	
10/28/05
    	
 
    	
0
    	
%
    	
468
    	
 
    	
USL   DR
    	
 
    
	
470
    	
 
    	
 
    	
 
    	
Review   CMC 2nd draft
    	
 
    	
6 wks
    	
 
    	
10/31/05
    	
 
    	
12/9/05
    	
 
    	
0
    	
%
    	
469
    	
 
    	
Orion   USL
    	
 
    
	
471
    	
 
    	
 
    	
 
    	
Make   revisions to 2nd draft CMC
    	
 
    	
6 wks
    	
 
    	
10/31/05
    	
 
    	
12/9/05
    	
 
    	
0
    	
%
    	
470FF
    	
 
    	
USL   DR
    	
 
    
	
472
    	
 
    	
 
    	
 
    	
Provide   Final CMC
    	
 
    	
0 wks
    	
 
    	
12/9/05
    	
 
    	
12/9/05
    	
 
    	
0
    	
%
    	
471
    	
 
    	
USL   DR
    	
 
    
	
473
    	
 
    	
 
    	
 
    	
Prepare   1st draft CMC Application Summary
    	
 
    	
2 wks
    	
 
    	
12/12/05
    	
 
    	
12/23/05
    	
 
    	
0
    	
%
    	
472
    	
 
    	
USL   DR
    	
 
    
	
474
    	
 
    	
 
    	
 
    	
Review   1st draft CMC Application Summary
    	
 
    	
1 wk
    	
 
    	
12/26/05
    	
 
    	
12/30/05
    	
 
    	
0
    	
%
    	
473
    	
 
    	
Orion   USL
    	
 
    
	
475
    	
 
    	
 
    	
 
    	
Make   revisions to 1st draft CMC Application Summary
    	
 
    	
1 wk
    	
 
    	
12/26/05
    	
 
    	
12/30/05
    	
 
    	
0
    	
%
    	
474FF
    	
 
    	
USL   DR
    	
 
    
	
476
    	
 
    	
 
    	
 
    	
Provide   2nd draft CMC Application Summary
    	
 
    	
0 wks
    	
 
    	
12/30/05
    	
 
    	
12/30/05
    	
 
    	
0
    	
%
    	
475
    	
 
    	
USL   DR
    	
 
    
	
477
    	
 
    	
 
    	
 
    	
Review   2nd draft CMC Application Summary
    	
 
    	
1 wk
    	
 
    	
1/2/06
    	
 
    	
1/6/06
    	
 
    	
0
    	
%
    	
476
    	
 
    	
Orion   USL
    	
 
    
	
478
    	
 
    	
 
    	
 
    	
Make   revisions to 2nd draft CMC Application Summary
    	
 
    	
1 wk
    	
 
    	
1/9/06
    	
 
    	
1/13/06
    	
 
    	
0
    	
%
    	
477
    	
 
    	
USL   DR
    	
 
    
	
479
    	
 
    	
 
    	
 
    	
Provide   final CMC Application Summary
    	
 
    	
0 wks
    	
 
    	
1/13/06
    	
 
    	
1/13/06
    	
 
    	
0
    	
%
    	
478
    	
 
    	
USL   DR
    	
 
    
	
480
    	
 
    	
 
    	
 
    	
NDA   Document Preparation Final Submission Package
    	
 
    	
21 days
    	
 
    	
1/16/06
    	
 
    	
2/13/06
    	
 
    	
0
    	
%
    	
461,297
    	
 
    	
USL
    	
 
    
	
481
    	
 
    	
 
    	
 
    	
NDA   Final Prep
    	
 
    	
1 wk
    	
 
    	
1/16/06
    	
 
    	
1/20/06
    	
 
    	
0
    	
%
    	
479
    	
 
    	
USL   DR
    	
 
    
	
482
    	
 
    	
 
    	
 
    	
NDA   Review
    	
 
    	
1 wk
    	
 
    	
1/23/06
    	
 
    	
1/27/06
    	
 
    	
0
    	
%
    	
481
    	
 
    	
USL   ORION
    	
 
    
	
483
    	
 
    	
 
    	
 
    	
NDA   Revisions
    	
 
    	
3 days
    	
 
    	
1/30/06
    	
 
    	
2/1/06
    	
 
    	
0
    	
%
    	
482
    	
 
    	
USL   DR
    	
 
    
	
484
    	
 
    	
 
    	
 
    	
Paginate
    	
 
    	
2 days
    	
 
    	
2/2/06
    	
 
    	
2/3/06
    	
 
    	
0
    	
%
    	
483
    	
 
    	
USL
    	
 
    
	
485
    	
 
    	
 
    	
 
    	
Table   of Contents
    	
 
    	
2 days
    	
 
    	
2/6/06
    	
 
    	
2/7/06
    	
 
    	
0
    	
%
    	
484
    	
 
    	
USL
    	
 
    
	
486
    	
 
    	
 
    	
 
    	
Copying
    	
 
    	
1 day
    	
 
    	
2/8/06
    	
 
    	
2/8/06
    	
 
    	
0
    	
%
    	
485
    	
 
    	
USL
    	
 
    
	
487
    	
 
    	
 
    	
 
    	
Color   Code & Compile
    	
 
    	
2 days
    	
 
    	
2/9/06
    	
 
    	
2/10/06
    	
 
    	
0
    	
%
    	
486
    	
 
    	
USL
    	
 
    
	
488
    	
 
    	
 
    	
 
    	
Final   On-site Review
    	
 
    	
1 day
    	
 
    	
2/13/06
    	
 
    	
2/13/06
    	
 
    	
0
    	
%
    	
487
    	
 
    	
USL
    	
 
    
	
489
    	
 
    	
 
    	
 
    	
Package   for Shipment
    	
 
    	
1 day
    	
 
    	
2/13/06
    	
 
    	
2/13/06
    	
 
    	
0
    	
%
    	
487
    	
 
    	
USL
    	
 
    
	
490
    	
 
    	
 
    	
 
    	
Submit   NDA
    	
 
    	
1 day
    	
 
    	
2/14/06
    	
 
    	
2/14/06
    	
 
    	
0
    	
%
    	
489
    	
 
    	
USL
    	
 
    
	
491
    	
 
    	
 
    	
 
    	
Ship   submission
    	
 
    	
1 day
    	
 
    	
2/14/06
    	
 
    	
2/14/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
492
    	
 
    	
 
    	
 
    	
FDA   REVIEW
    	
 
    	
240 days
    	
 
    	
2/15/06
    	
 
    	
1/16/07
    	
 
    	
0
    	
%
    	
490
    	
 
    	
USL
    	
 
    
	
493
    	
 
    	
 
    	
 
    	
FDA   Review
    	
 
    	
12 mons
    	
 
    	
2/15/06
    	
 
    	
1/16/07
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
494
    	
 
    	
 
    	
 
    	
Six   Mo. Point
    	
 
    	
6 mons
    	
 
    	
2/15/06
    	
 
    	
8/1/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
495
    	
 
    	
 
    	
 
    	
Target   Approval
    	
 
    	
0 mons
    	
 
    	
1/16/07
    	
 
    	
1/16/07
    	
 
    	
0
    	
%
    	
493
    	
 
    	
USL
    	
 
    
	
496
    	
 
    	
 
    	
 
    	
Process   validation
    	
 
    	
240 days
    	
 
    	
1/18/06
    	
 
    	
12/19/06
    	
 
    	
0
    	
%
    	
555FS-34   wks
    	
 
    	
Orion
    	
 
    
	
497
    	
 
    	
 
    	
 
    	
USL   reccomendations for commercial process validation (PV) protocol
    	
 
    	
12 wks
    	
 
    	
1/18/06
    	
 
    	
4/11/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
498
    	
 
    	
 
    	
 
    	
USL   recommendations In-Process Delays (IPD) protocol
    	
 
    	
12 wks
    	
 
    	
1/18/06
    	
 
    	
4/11/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

82

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
499
    	
 
    	
 
    	
 
    	
USL   recommendations for Packaging Validation (PackV) protocol
    	
 
    	
12 wks
    	
 
    	
1/18/06
    	
 
    	
4/11/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
500
    	
 
    	
 
    	
 
    	
Orion   prepares PV protocol
    	
 
    	
3 wks
    	
 
    	
4/12/06
    	
 
    	
5/2/06
    	
 
    	
0
    	
%
    	
499
    	
 
    	
Orion
    	
 
    
	
501
    	
 
    	
 
    	
 
    	
Orion   prepares In-Process delays (IPD) protocol
    	
 
    	
3wks
    	
 
    	
4/12/06
    	
 
    	
5/2/06
    	
 
    	
0
    	
%
    	
498
    	
 
    	
Orion
    	
 
    
	
502
    	
 
    	
 
    	
 
    	
Orion   prepares PackV protocol
    	
 
    	
3 wks
    	
 
    	
5/3/06
    	
 
    	
5/23/06
    	
 
    	
0
    	
%
    	
500
    	
 
    	
Orion
    	
 
    
	
503
    	
 
    	
 
    	
 
    	
Orion   approves PV protocol
    	
 
    	
1 wk
    	
 
    	
5/24/06
    	
 
    	
5/30/06
    	
 
    	
0
    	
%
    	
502
    	
 
    	
Orion
    	
 
    
	
504
    	
 
    	
 
    	
 
    	
USL   approves PV protocol
    	
 
    	
2 wks
    	
 
    	
5/31/06
    	
 
    	
6/13/06
    	
 
    	
0
    	
%
    	
503
    	
 
    	
USL
    	
 
    
	
505
    	
 
    	
 
    	
 
    	
Orion   approves IPD protocol
    	
 
    	
1 wk
    	
 
    	
5/3/06
    	
 
    	
5/9/06
    	
 
    	
0
    	
%
    	
501
    	
 
    	
Orion
    	
 
    
	
506
    	
 
    	
 
    	
 
    	
USL   approves IPD protocol
    	
 
    	
1 wk
    	
 
    	
5/10/06
    	
 
    	
5/16/06
    	
 
    	
0
    	
%
    	
505
    	
 
    	
USL
    	
 
    
	
507
    	
 
    	
 
    	
 
    	
Orion   approves PackV protocol
    	
 
    	
1 wk
    	
 
    	
5/24/06
    	
 
    	
5/30/06
    	
 
    	
0
    	
%
    	
502
    	
 
    	
Orion
    	
 
    
	
508
    	
 
    	
 
    	
 
    	
USL   approves PackV protocol
    	
 
    	
2 wks
    	
 
    	
5/31/06
    	
 
    	
6/13/06
    	
 
    	
0
    	
%
    	
507
    	
 
    	
Orion
    	
 
    
	
509
    	
 
    	
 
    	
 
    	
Start   PV protocol execution
    	
 
    	
1 day
    	
 
    	
6/14/06
    	
 
    	
6/14/06
    	
 
    	
0
    	
%
    	
504,512SS
    	
 
    	
Orion
    	
 
    
	
510
    	
 
    	
 
    	
 
    	
Start   IPD protocol execution
    	
 
    	
1 day
    	
 
    	
5/17/06
    	
 
    	
5/17/06
    	
 
    	
0
    	
%
    	
506,514SS-12   wks
    	
 
    	
Orion
    	
 
    
	
511
    	
 
    	
 
    	
 
    	
Start   PackV protocol execution
    	
 
    	
1 day
    	
 
    	
4/12/06
    	
 
    	
4/12/06
    	
 
    	
0
    	
%
    	
499.515SF-12   wks
    	
 
    	
Orion
    	
 
    
	
512
    	
 
    	
 
    	
 
    	
Manufacture   first (of three) commercial batches
    	
 
    	
1 day
    	
 
    	
6/14/06
    	
 
    	
6/14/06
    	
 
    	
0
    	
%
    	
504
    	
 
    	
Orion
    	
 
    
	
513
    	
 
    	
 
    	
 
    	
Manufacture   second (of three) commercial batches
    	
 
    	
1 day
    	
 
    	
6/15/06
    	
 
    	
6/15/06
    	
 
    	
0
    	
%
    	
512
    	
 
    	
Orion
    	
 
    
	
514
    	
 
    	
 
    	
 
    	
Manufacture   third (of three) commercial batches (Portion used for IPD)
    	
 
    	
1 day
    	
 
    	
6/16/06
    	
 
    	
6/16/06
    	
 
    	
0
    	
%
    	
513
    	
 
    	
Orion
    	
 
    
	
515
    	
 
    	
 
    	
 
    	
Package   first (of three) commercial batches
    	
 
    	
2 days
    	
 
    	
6/14/06
    	
 
    	
6/15/06
    	
 
    	
0
    	
%
    	
508
    	
 
    	
Orion
    	
 
    
	
516
    	
 
    	
 
    	
 
    	
Package   second (of three) commercial batches
    	
 
    	
2 days
    	
 
    	
6/16/06
    	
 
    	
6/19/06
    	
 
    	
0
    	
%
    	
515
    	
 
    	
Orion
    	
 
    
	
517
    	
 
    	
 
    	
 
    	
Package   third (of three) commercial batches
    	
 
    	
2 days
    	
 
    	
6/20/06
    	
 
    	
6/21/06
    	
 
    	
0
    	
%
    	
516
    	
 
    	
Orion
    	
 
    
	
518
    	
 
    	
 
    	
 
    	
Perform   PV testing
    	
 
    	
6 wks
    	
 
    	
6/15/06
    	
 
    	
7/26/06
    	
 
    	
0
    	
%
    	
512
    	
 
    	
Orion
    	
 
    
	
519
    	
 
    	
 
    	
 
    	
Perform   IPD testing
    	
 
    	
6 wks
    	
 
    	
7/27/06
    	
 
    	
9/6/06
    	
 
    	
0
    	
%
    	
514,518
    	
 
    	
Orion
    	
 
    
	
520
    	
 
    	
 
    	
 
    	
Perform   PackV testing
    	
 
    	
75 days
    	
 
    	
6/20/06
    	
 
    	
10/2/06
    	
 
    	
0
    	
%
    	
517SS
    	
 
    	
Orion
    	
 
    
	
521
    	
 
    	
 
    	
 
    	
Prepare   PV Summary Report
    	
 
    	
3 wks
    	
 
    	
7/27/06
    	
 
    	
8/16/06
    	
 
    	
0
    	
%
    	
518
    	
 
    	
Orion
    	
 
    
	
522
    	
 
    	
 
    	
 
    	
Prepare   IPD Summary Report
    	
 
    	
3 wks
    	
 
    	
9/7/06
    	
 
    	
9/27/06
    	
 
    	
0
    	
%
    	
519
    	
 
    	
Orion
    	
 
    
	
523
    	
 
    	
 
    	
 
    	
Prepare   PackV Summary Report
    	
 
    	
3 wks
    	
 
    	
10/3/06
    	
 
    	
10/23/06
    	
 
    	
0
    	
%
    	
520
    	
 
    	
Orion
    	
 
    
	
524
    	
 
    	
 
    	
 
    	
Audit   PV, IPD, PackV data
    	
 
    	
5 wks
    	
 
    	
10/24/06
    	
 
    	
11/27/06
    	
 
    	
0
    	
%
    	
521,522,523
    	
 
    	
Orion
    	
 
    
	
525
    	
 
    	
 
    	
 
    	
Orion   approves PV Summary Report
    	
 
    	
1 wk
    	
 
    	
11/28/06
    	
 
    	
12/4/06
    	
 
    	
0
    	
%
    	
524
    	
 
    	
Orion
    	
 
    
	
526
    	
 
    	
 
    	
 
    	
USL   approves PV summary report
    	
 
    	
2 wks
    	
 
    	
12/5/06
    	
 
    	
12/18/06
    	
 
    	
0
    	
%
    	
525
    	
 
    	
USL
    	
 
    
	
527
    	
 
    	
 
    	
 
    	
Orion   approves IPD Summary report
    	
 
    	
1 wk
    	
 
    	
11/28/06
    	
 
    	
12/4/06
    	
 
    	
0
    	
%
    	
524
    	
 
    	
Orion
    	
 
    
	
528
    	
 
    	
 
    	
 
    	
USL   Approves IPD summary report
    	
 
    	
2 wks
    	
 
    	
12/5/06
    	
 
    	
12/18/06
    	
 
    	
0
    	
%
    	
527
    	
 
    	
USL
    	
 
    
	
529
    	
 
    	
 
    	
 
    	
Orion   approves PackV Summary Report
    	
 
    	
1 wk
    	
 
    	
11/28/06
    	
 
    	
12/4/06
    	
 
    	
0
    	
%
    	
524
    	
 
    	
Orion
    	
 
    
	
530
    	
 
    	
 
    	
 
    	
USL   approves PackV summary report
    	
 
    	
2 wks
    	
 
    	
12/5/06
    	
 
    	
12/18/06
    	
 
    	
0
    	
%
    	
529
    	
 
    	
USL
    	
 
    
	
531
    	
 
    	
 
    	
 
    	
Product   available to ship
    	
 
    	
1 day
    	
 
    	
12/19/06
    	
 
    	
12/19/06
    	
 
    	
0
    	
%
    	
526,530
    	
 
    	
USL
    	
 
    
	
532
    	
 
    	
 
    	
 
    	
PAI   Preparation and FDA Inspection
    	
 
    	
120 days
    	
 
    	
2/15/06
    	
 
    	
8/1/06
    	
 
    	
0
    	
%
    	
490
    	
 
    	
Orion
    	
 
    
	
533
    	
 
    	
 
    	
 
    	
Strategy   for Formulary
    	
 
    	
2 wks
    	
 
    	
2/15/06
    	
 
    	
2/28/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   and Orion
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

83

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
534
    	
 
    	
 
    	
 
    	
Formulary   Submissions
    	
 
    	
4 wks
    	
 
    	
3/1/06
    	
 
    	
3/28/06
    	
 
    	
0
    	
%
    	
533
    	
 
    	
USL   and Orion
    	
 
    
	
535
    	
 
    	

    	
 
    	
Development   Report
    	
 
    	
6 wks
    	
 
    	
2/15/06
    	
 
    	
3/28/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   and Orion
    	
 
    
	
536
    	
 
    	
 
    	
 
    	
Audit   DR
    	
 
    	
3 wks
    	
 
    	
3/29/06
    	
 
    	
4/18/06
    	
 
    	
0
    	
%
    	
535
    	
 
    	
USL   and Orion
    	
 
    
	
537
    	
 
    	
 
    	
 
    	
Review/Approve   DR
    	
 
    	
3 wks
    	
 
    	
4/19/06
    	
 
    	
5/9/06
    	
 
    	
0
    	
%
    	
536
    	
 
    	
USL   and Orion
    	
 
    
	
538
    	
 
    	
 
    	
 
    	
Prep   Contract Mfr for PAI
    	
 
    	
120 days
    	
 
    	
2/15/06
    	
 
    	
8/1/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   and Orion
    	
 
    
	
539
    	
 
    	
 
    	
 
    	
Visit   Contract Mfr
    	
 
    	
2 days
    	
 
    	
2/15/06
    	
 
    	
2/16/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   and Orion
    	
 
    
	
540
    	
 
    	
 
    	
 
    	
CM   Audit Report
    	
 
    	
2 wks
    	
 
    	
2/17/06
    	
 
    	
3/2/06
    	
 
    	
0
    	
%
    	
539
    	
 
    	
USL   and Orion
    	
 
    
	
541
    	
 
    	
 
    	
 
    	
CM   Follow-up
    	
 
    	
6 mons
    	
 
    	
2/15/06
    	
 
    	
8/1/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   and Orion
    	
 
    
	
542
    	
 
    	
 
    	
 
    	
Prep   API Mfr for PAI
    	
 
    	
120 days
    	
 
    	
2/15/06
    	
 
    	
8/1/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   and Orion
    	
 
    
	
543
    	
 
    	
 
    	
 
    	
Visit   API Mfr
    	
 
    	
2 days
    	
 
    	
2/15/06
    	
 
    	
2/16/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   and Orion
    	
 
    
	
544
    	
 
    	
 
    	
 
    	
API   Mfr Audit Report
    	
 
    	
2 wks
    	
 
    	
2/17/06
    	
 
    	
3/2/06
    	
 
    	
0
    	
%
    	
543
    	
 
    	
USL   and Orion
    	
 
    
	
545
    	
 
    	
 
    	
 
    	
API   Mfr Follow-up
    	
 
    	
6 mons
    	
 
    	
2/15/06
    	
 
    	
8/1/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   and Orion
    	
 
    
	
546
    	
 
    	
 
    	
 
    	
Prep   Clinical Supply Mfr for PAI
    	
 
    	
120 days
    	
 
    	
2/15/06
    	
 
    	
8/1/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   and Orion
    	
 
    
	
547
    	
 
    	
 
    	
 
    	
Visit   Clinical Supply Mfr
    	
 
    	
2 days
    	
 
    	
2/15/06
    	
 
    	
2/16/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   and Orion
    	
 
    
	
548
    	
 
    	
 
    	
 
    	
Clinical   Supply Mfr Audit Report
    	
 
    	
2 wks
    	
 
    	
2/17/06
    	
 
    	
3/2/06
    	
 
    	
0
    	
%
    	
547
    	
 
    	
USL   and Orion
    	
 
    
	
549
    	
 
    	
 
    	
 
    	
Clinical   Supply Mfr Follow-up
    	
 
    	
6 mons
    	
 
    	
2/15/06
    	
 
    	
8/1/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL   and Orion
    	
 
    
	
550
    	
 
    	
 
    	
 
    	
Prep   Clinical Sites for PAI
    	
 
    	
120 days
    	
 
    	
2/15/06
    	
 
    	
8/1/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
551
    	
 
    	
 
    	
 
    	
Visit   Clinical Sites
    	
 
    	
6 wks
    	
 
    	
2/15/06
    	
 
    	
3/28/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
552
    	
 
    	
 
    	
 
    	
Clinical   Site Audit Report
    	
 
    	
4 wks
    	
 
    	
3/29/06
    	
 
    	
4/25/06
    	
 
    	
0
    	
%
    	
551
    	
 
    	
USL
    	
 
    
	
554
    	
 
    	
 
    	
 
    	
Clinical   Site Follow-up
    	
 
    	
6 mons
    	
 
    	
2/15/06
    	
 
    	
8/1/06
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
554
    	
 
    	
 
    	
 
    	
FDA   PAI - Address and Respond to PAI Observations and/or 483 Items
    	
 
    	
60 days
    	
 
    	
8/2/06
    	
 
    	
10/24/06
    	
 
    	
0
    	
%
    	
490
    	
 
    	
USL
    	
 
    
	
555
    	
 
    	
 
    	
 
    	
Receive   results
    	
 
    	
6 wks
    	
 
    	
8/2/06
    	
 
    	
9/12/06
    	
 
    	
0
    	
%
    	
538.542,546,551
    	
 
    	
USL
    	
 
    
	
556
    	
 
    	
 
    	
 
    	
Respond   to 483. if needed
    	
 
    	
6 wks
    	
 
    	
9/13/06
    	
 
    	
10/24/06
    	
 
    	
0
    	
%
    	
555
    	
 
    	
USL
    	
 
    
	
557
    	
 
    	
 
    	
 
    	
Marketing   Prep.
    	
 
    	
120 days
    	
 
    	
10/13/03
    	
 
    	
4/8/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
558
    	
 
    	
 
    	
 
    	
Market   Research
    	
 
    	
1 mon
    	
 
    	
10/13/03
    	
 
    	
11/7/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
559
    	
 
    	
 
    	
 
    	
Preliminary   Sales Forecast
    	
 
    	
2 wks
    	
 
    	
10/13/03
    	
 
    	
10/24/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
560
    	
 
    	
 
    	
 
    	
Secondary   Sales Forecast
    	
 
    	
3 days
    	
 
    	
10/27/03
    	
 
    	
10/29/03
    	
 
    	
0
    	
%
    	
559
    	
 
    	
 
    	
 
    
	
561
    	
 
    	
 
    	
 
    	
Select   Marketing Packaging
    	
 
    	
4 wks
    	
 
    	
10/13/03
    	
 
    	
11/7/03
    	
 
    	
0
    	
%
    	
558SS
    	
 
    	
USL
    	
 
    
	
562
    	
 
    	
 
    	
 
    	
Select   NDC #
    	
 
    	
1 day
    	
 
    	
10/13/03
    	
 
    	
10/13/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
563
    	
 
    	
 
    	
 
    	
Finalize   Secondary Packaging for Commercial
    	
 
    	
2 wks
    	
 
    	
10/13/03
    	
 
    	
10/24/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
564
    	
 
    	
 
    	
 
    	
Develop   Target Package Insert
    	
 
    	
2 mons
    	
 
    	
10/13/03
    	
 
    	
12/5/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
565
    	
 
    	
 
    	
 
    	
Order   Competitor products- Mkt./RA
    	
 
    	
4 wks
    	
 
    	
10/13/03
    	
 
    	
11/7/03
    	
 
    	
0
    	
%
    	
558SS
    	
 
    	
USL
    	
 
    
	
566
    	
 
    	
 
    	
 
    	
Dev.   Prelim. Labels (Request for Labeling)
    	
 
    	
4 wks
    	
 
    	
10/13/03
    	
 
    	
11/7/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
567
    	
 
    	
 
    	
 
    	
Market   Surveillance
    	
 
    	
6 mons
    	
 
    	
10/13/03
    	
 
    	
4/8/04
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    
	
568
    	
 
    	
 
    	
 
    	
Market   Research/Focus Groups
    	
 
    	
8 wks
    	
 
    	
10/13/03
    	
 
    	
12/5/03
    	
 
    	
0
    	
%
    	
 
    	
 
    	
USL
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

84

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

	
ID
    	
 
    	

    	
 
    	
Task Name
    	
 
    	
Duration
    	
 
    	
Start
    	
 
    	
Finish
    	
 
    	
% Complete
    	
 
    	
Predecessors
    	
 
    	
Resource Names
    	
 
    
	
569
    	
 
    	
 
    	
 
    	
Identify/Register   Trade Name
    	
 
    	
10 wks
    	
 
    	
12/8/03
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
568
    	
 
    	
USL
    	
 
    
	
570
    	
 
    	
 
    	
 
    	
Concept   Development/Initial Marketing Plan
    	
 
    	
10 wks
    	
 
    	
12/8/03
    	
 
    	
2/26/04
    	
 
    	
0
    	
%
    	
568
    	
 
    	
USL
    	
 
    
	
571
    	
 
    	
ü
    	
 
    	
Budget
    	
 
    	
1 day
    	
 
    	
10/13/03
    	
 
    	
10/13/03
    	
 
    	
100
    	
%
    	
 
    	
 
    	
 
    	
 
    
	
572
    	
 
    	
ü
    	
 
    	
USL   Project Budget
    	
 
    	
1 day
    	
 
    	
10/13/03
    	
 
    	
10/13/03
    	
 
    	
100
    	
%
    	
 
    	
 
    	
USL
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

85

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith   Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development   Timeline - Divigel
    	
 
    

 

15                  File specifications for each DS supplier

Note Addition 9/22/03:

Current plan is to submit IND with two sets of specifications (Rather than a single unified set) and wait for FDA directive on this item. (Sec if FDA requests a single specification)

 

17                  Provide the potential synthesis Impurities for API. Provide the degradation pathway(s) for API Including name/chemical structures for potential degradants

Note Addition 9/22/03-USL would like impurity data compiled from the start of European commercialization (19967)

 

41                  DMFs, Debarments and cGMP documents from suppliers

Information needed from all suppliers (API, ethanol, excipients and laminate.)

 

44                  Tabulate release data from the DP lots used for tox, stability and clinical, including formulation number, packaging material, DS lot numbers used, release limits, etc. Provide C of A’s see notes

Provide C of A s for each DP lot used in the toxicology program (3 studies) clinical and stability program to include the lot number of the drug substance used in the DP lot reporting all impurities quantitatively.

 

45                  DP stress study to ID degradants if found under ICH conditions to be above 0.1%; 0.5% specification and 0.1% reporting requirement

DP forced degradation and ICH photostability studies to be performed using matenats from both API suppliers.

 

56                  Validation of HPLC Assay - Provide or perform specificity validation for EF-108 formulation with new ingredients. (Forced Degradation)

(Original validation referenced without providing the data.) Also, provide information to show that there is no interference with assay from placebo.

 

57                  Provide the viscosity test sample size for release method and validation -11g

Current procedure to be clarified to USL, and if needed number of sachets to be included instead of 11g sample size

 

60                  Will Be Outsourced -Develop in vitro release test and specification limits per SUPAC Guidance, May 1997, page 19 (which means a Franz cell method) and qualify pivotal clinical studThis in-vitro method will also be [ILLEGIBLE]

This item must be submitted with IND. Test method and test results are required; however, the IND specification can be to “report results.”

 

61                  Perform Microbial Challenge Test USP<51>(Antimicrobial Effectiveness Testing) or other relevant studies and provide report, see notes

·                  Information must be sufficient to support elimination of annual microbial testing for lot release or stability or,

·                  Change frequency to include microbial testing for every batch if above task is unable to be completed.

·                  According to our opinion, the relevant method to demonstrate the possibility to eliminate the microbiological release testing for Divigel is described in USP <51> Microbial Limit Test (Preparatory testing). The sample is inoculated with a low number of separate viable cultures of Staphylococcus aureus. Escherichia coll. Pseudomonas aeruginosa and Salmonella. The failure to isolate the inoculated microbes serves to indicate that the product is not likely to be contaminated with this microbe. This item needs to be discussed further.

 

62                  Statement from Orion that there have been no microbial limit testing failures over X Years and Y Batches

To aid in justification to delete Mcirobial Limits test statement is required that Orion has tested “X Lots” on skip basis over “Y Years” since product European registration and no failures have been observed. (See Q6B, Decision tree 8)

 

66                  Perform the content uniformity par USP weight variation on each batch release. If required by FDA perform individual assays and provide copy of method. Note Sept 12 update

Sept 12 weight variations vs estradiol assay of individual sachet

1. file IND based on weight variation with scientific justification

2. Address FDA directives in NDA

Orion may need to perfrom estradiol assay based CU per USP, since USP criteria isn’t explicit for this dosage form.

 

67                  Change Uniformity of Mass to USP “Minimum Fill”. Follow USP limits. - see notes (Sent to Orion via Email)

Minimum Fill vs. Uniformity of Mass

 

Orion Definition of Uniformity or Mass as Defined in DP Specification

Number of units tested: 20

Specification: Minimum of 90% within mean mass ± 0.075 x mean mass

100% within mean mass ±0.15 x mean mass

 

Uniformity of Mass (worded another way)

Number of units tested: 20

Specification: Two outside 92.5 – 107.5% label claim

None outside 85-115% label claim

 

Minimum Fill (USP <755>) Applies to gels

Number tested 10 or 30 depending upon results

Specification:

First 10 units: 10/10 NLT 90% claim

If 1 is outside this limit, test an additional 20 units

 

Additional 20 units: A average of 30 is NLT 90% of label claim.

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

86

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith   Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development   Timeline - Divigel
    	
 
    

 

73                  Provide details of reference standards used for estradiol assay - purchased from USP, EP, or characterized in-house? (Should use USP reference standard or show equivalence to USP RS). See notes

Also provide reference standards information for related substances and show equivalency or traceability to USP.

 

75                  Obtain DMF,cGMP certificate and debarment for the IC container/closure system for components and fabrication See Notes

Verify the following:

 

A DMF,cGMP and debarment authorization exists for the IC container/closure system. Clarify whether it covers the components of the laminate or just the fabrication of the laminate. Clarify the source and composition of each component used in the laminate and provide appropriate DMF authorizations. May also need information on all other suppliers for other laminate components

 

79                  Provide existing Leachible/Extractable report

File current study in IND

Address FDA direction in NDA

 

May need to conduct additional study- The revision may involve leachible isolation and identification, or tox study of the leachibles.

 

80                  DP Stability - see notes

Orion stability studies need to be representative of proposed market package Including all ink sources. Note is from 8/2003

USL DD Results - 9/11/03

Provide a justification as to why the [***] stability samples are out of specifications (high) for fill volume in the first set of stability data presented, e.g., Lot CAC21F1, CAC22F1.

Investigate the average weight exceeding the upper [***] limit for the [***] lots on stability.

 

·                  Answer: These two lots of  [***] sachets were filled with a 100 mg overage (i.e., [***] acceptable weight range) instead of the current 75 mg overage (i.e., [***]  acceptable weight range). The [***] sachet overage was reduced from 100 mg to 75 mg based on the Sachet Emptying Study results.

 

·                  Clarify whether stability studies were conducted with printed sachets (leachables).

Answer: The sachets are printed.

 

·                  Add ethanol testing to ongoing stability protocols

Answer: Ethanol testing has been added to the new stability studies mounted for the USA in the IC laminate.

 

·                  Orion stability studies need to be representative of proposed market package including all ink sources.

Answer:  Stability studies mounted to date are with printed sachets.

 

81                  For newest DP stability studies in 1C laminate (started May 2003), provide details, e.g., number of batches, package sizes stored, drug substance suppliers, protocols including pull dates. It is suggested that the 30 [ILLEGIBLE]

Also for all clinical lots and two additional lots of 0.25g

 

210           FDA Informational Meeting

Informational meeting not a formal end of Phase II meeting.

 

239           Package PK, Transferability, Washability study material if in Orion

Packaging for PK studies at Orion takes about 2 weeks/study + shipping

 

241           Package Phase III Material if packaging in Orion

for a phase III study, packaging at Orion takes approximately 6 weeks + shipping

 

370           Data Entry

Duration represents six months of enrollment and final patient treatment of 12 weeks for a total of 9 months of study conduct

 

399           Review available EF-108 ValidationData in IIB laminate

EF-108 Reformulation Validation Batches are as follows (200 kg batch):

 

	
API Supplier
    	
Diosynth
    	
Diosynth
    	
Schering
    
	
Lot Number
    	
CFC21
    	
DDC21
    	
CLC16
    
	
Laminate
    	
IIB
    	
IIB
    	
IIB
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

87

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
Upsher-Smith Laboratories & Orion Pharma
    	
 
    
	
 
    	
Development Timeline - Divigel
    	
 
    

 

400           Two development batches need to be made to support EF-108 formulation as follows: See Notes May need to Include 0.25 dosage

 

#1 - slower speeds, shorter time;

#2 - faster speeds, longer time

 

	
Development Batch
    	
 
    	
#1
    	
 
    	
#2
    	
 
    
	
Carbomer   Addition
    	
 
    	
10 Minutes
    	
 
    	
20 Minutes
    	
 
    
	
Mixer
    	
 
    	
II
    	
 
    	
II
    	
 
    
	
Homgenizer after   each addition
    	
 
    	
Minimum (300)
    	
 
    	
Minimum (300)
    	
 
    
	
Homgenizer low   speed
    	
 
    	
8 minutes minimum (300)
    	
 
    	
12 minutes minimum (300)
    	
 
    
	
Homogenizer high   speed
    	
 
    	
I8 minutes 1000 rpm
    	
 
    	
22 minutes 1100 rpm
    	
 
    
	
H20 and   TEA Addition
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Additional time   (min)
    	
 
    	
5
    	
 
    	
10
    	
 
    
	
Homogenizer   speed
    	
 
    	
1000
    	
 
    	
1100
    	
 
    
	
Propylene   Glycol Addition
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Additional time   (min)
    	
 
    	
2
    	
 
    	
3
    	
 
    
	
Homogenizer   speed
    	
 
    	
1000
    	
 
    	
1100
    	
 
    
	
API and   Ethanol Addition
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Additional time   (min)
    	
 
    	
5
    	
 
    	
10
    	
 
    
	
Homogenizer   speed
    	
 
    	
1000
    	
 
    	
1100
    	
 
    
	
De-aeration
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Time
    	
 
    	
8
    	
 
    	
12
    	
 
    
	
Homogenizer
    	
 
    	
1000
    	
 
    	
1100
    	
 
    
	
Possible   Extra
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Time
    	
 
    	
NA
    	
 
    	
5
    	
 
    
	
Homogenizer
    	
 
    	
NA
    	
 
    	
1100
    	
 
    

 

535           Development Report

 

Some version of this will be submitted in the NDA

 

572           USL Project Budget

 

	
Cost
    	
 
    	
Orion*
    	
 
    	
Upsher-Smith
    	
 
    
	
Internal Labor
    	
 
    	
2,100,000
    	
 
    	
0
    	
 
    
	
Clinical   Expenses
    	
 
    	
0
    	
 
    	
11,588,000
    	
 
    
	
Regulatory   Expenses
    	
 
    	
0
    	
 
    	
1,920,000
    	
 
    
	
Regulatory   Internal Labor
    	
 
    	
0
    	
 
    	
200,000
    	
 
    
	
Analytical Expenses
    	
 
    	
0
    	
 
    	
418,000
    	
 
    
	
Analytical   Internal Labor
    	
 
    	
0
    	
 
    	
222,000
    	
 
    
	
R&D   Materials and Outside Expenses
    	
 
    	
0
    	
 
    	
283,000
    	
 
    
	
Milestone   Payments
    	
 
    	
0
    	
 
    	
1,750,000
    	
 
    
	
Franz Cell Test   - Outsourcing
    	
 
    	
45000
    	
 
    	
0
    	
 
    
	
Total
    	
 
    	
2,145,000
    	
 
    	
I6,381,000
    	
 
    
	
Total budget
    	
 
    	
18,526,000
    	
 
    	
 
    	
 
    

 

	
11/24/03   12:19 PM
    	
 
    	
Kingfisher Final Development Timeline.mpp
    
	
 
    	
Approved Timeline
    	
 
    

 

88

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

QUALITY ASSURANCE AGREEMENT

 

Overview

 

This Quality Assurance Agreement is between Orion Corporation (hereinafter referred to as “Orion” or “Supplier”), a corporation organized and existing under the laws of Finland, with its principal offices at Orionintie 1 (P.O. Box 65) FIN-02200 Espoo, Finland and Upsher-Smith Laboratories Inc. (hereinafter referred to as “USL” or “Purchaser”), a corporation organized and existing under the laws of the United States, with its principal offices at 6701 Evenstad Drive, Maple Grove, MN, 55369.

 

This Quality Assurance Agreement sets out the responsibilities of the parties relating to the manufacturing, packaging and supply of the products described in the License, Supply, Marketing, Distribution and Collaboration Agreement between the parties.  Manufacturing, packaging, analytical testing, storage, release and stability testing by Supplier will comply with CGMP standards defined in 21US Code of Federal Regulations parts 210/211.  Supplier is responsible for operating within the agreed upon requirements provided by Purchaser, which will be based on the approved marketing authorization application held by Purchaser, for providing Purchaser with Product that meets all agreed upon quality criteria.

 

Confidentiality

 

Without limiting the generality of any confidentiality agreement(s) in effect between the parties, each party agrees to hold all information furnished, disclosed or made known to either of them or their respective representatives by the other party or by the examination of the records of the other or otherwise obtained from the other party, whether such information is furnished, disclosed or made known orally, in writing or by any other means whatsoever, confidential and shall not disclose, or permit disclosure of such information.  Each party agrees that it has no right, title or interest whatsoever in or to the confidential information of the other and that no right or license in such confidential information is implied or granted.

 

Duration of Agreement; Language

 

This agreement shall commence upon the execution and delivery hereof by the parties and may be terminated at any time by either party in a timeframe that is consistent with the License, Supply, Marketing, Distribution and Collaboration Agreement entered into between the parties on even date herewith (the “License Agreement”).  This Agreement is an exhibit to and a part of the License Agreement, and incorporated therein by reference.  In the event of any inconsistency between this Agreement and the License Agreement, the License Agreement shall govern, and this Agreement must promptly be amended to conform with the License Agreement.  The meaning of all words and phrases in this Agreement shall be defined, construed and interpreted in English, and the Parties acknowledge that the terms and provisions of this Agreement, as stated in English, accurately reflect their intent and understanding.  USL shall not be responsible in any manner for any interpretation or translation of this Agreement that Orion may obtain.

 

89

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Revisions to Agreement

 

No amendment to the terms of this Agreement shall be binding on the parties hereto unless made in writing and signed by authorized representative(s) of each of the parties.

 

Communication

 

The parties have identified and listed in Appendix I a list of personnel responsible for the administration of this agreement.  Personnel may be added to or deleted from Appendix I upon written notice to the other party.

 

Responsibilities

 

	
AREA OF RESPONSIBILITY
    	
 
    	
ORION
    	
 
    	
USL
    
	
Raw materials
    	
 
    	
 
    	
 
    	
 
    
	
·       Establish   specifications (grade, testing parameters, acceptance criteria)
    	
 
    	
X
    	
 
    	
X
    
	
·       Approve   specifications (grade, testing parameters, acceptance criteria)
    	
 
    	
X
    	
 
    	
X
    
	
·       Test   method validation
    	
 
    	
X
    	
 
    	
 
    
	
·       Vendor   selection
    	
 
    	
X
    	
 
    	
 
    
	
·       Vendor   approval
    	
 
    	
X
    	
 
    	
 
    
	
·       Raw   material procurement
    	
 
    	
X
    	
 
    	
 
    
	
·       Inspection,   testing documents, testing and release/rejection
    	
 
    	
X
    	
 
    	
 
    
	
·       Retention   of raw materials samples
    	
 
    	
X
    	
 
    	
 
    
	
Contract laboratory testing
    	
 
    	
X
    	
 
    	
 
    
	
·       Selection   of lab for testing of raw materials, bulk product, and finished product
    	
 
    	
X
    	
 
    	
 
    
	
·       Approval   of lab
    	
 
    	
X
    	
 
    	
 
    
	
Packaging materials
    	
 
    	
 
    	
 
    	
 
    
	
·       Artwork   development, review and approval
    	
 
    	
 
    	
 
    	
X
    
	
·       Establish   specifications (testing parameters, acceptance criteria)
    	
 
    	
X
    	
 
    	
X
    
	
·       Approve   specifications (testing parameters, acceptance criteria)
    	
 
    	
X
    	
 
    	
X
    
	
·       Vendor   selection
    	
 
    	
X
    	
 
    	
 
    
	
·       Vendor   approval
    	
 
    	
X
    	
 
    	
 
    
	
·       Packaging   materials procurement
    	
 
    	
X
    	
 
    	
 
    
	
·       Inspection,   inspection documents, testing and release/rejection
    	
 
    	
X
    	
 
    	
 
    
	
Master formula
    	
 
    	
X
    	
 
    	
 
    
	
Master manufacturing batch record preparation
    	
 
    	
X
    	
 
    	
 
    
	
Master manufacturing batch record approval
    	
 
    	
X
    	
 
    	
X
    
	
Master packaging batch record preparation
    	
 
    	
X
    	
 
    	
 
    
	
Master packaging batch record approval
    	
 
    	
X
    	
 
    	
X
    
	
Facility validation
    	
 
    	
X
    	
 
    	
 
    
	
Equipment qualification/validation
    	
 
    	
X
    	
 
    	
 
    
	
Cleaning validation
    	
 
    	
X
    	
 
    	
 
    
	
Manufacturing process validation
    	
 
    	
X
    	
 
    	
 
    
	
Packaging process validation
    	
 
    	
X
    	
 
    	
 
    
	
Computerized system validation
    	
 
    	
X
    	
 
    	
 
    
	
Allocation method of lot number and expiry date of the products
    	
 
    	
X
    	
 
    	
X
    
	
Preparation and approval of cleaning procedures
    	
 
    	
X
    	
 
    	
 
    

 

90

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
AREA OF RESPONSIBILITY
    	
 
    	
ORION
    	
 
    	
USL
    
	
Manufacturing of bulk products per approved product master   formulae and procedures
    	
 
    	
X
    	
 
    	
 
    
	
Establish Bulk product specifications (testing parameters,   acceptance criteria)
    	
 
    	
X
    	
 
    	
X
    
	
Approve Bulk product specifications (testing parameters,   acceptance criteria)
    	
 
    	
X
    	
 
    	
X
    
	
Bulk product test method validation
    	
 
    	
X
    	
 
    	
 
    
	
Bulk product sampling
    	
 
    	
X
    	
 
    	
 
    
	
Bulk product testing
    	
 
    	
X
    	
 
    	
 
    
	
Review of manufacturing batch documents
    	
 
    	
X
    	
 
    	
 
    
	
Release/rejection of bulk product for filling and packaging
    	
 
    	
X
    	
 
    	
 
    
	
Filling and packaging of released bulk products per approved   packaging work orders
    	
 
    	
X
    	
 
    	
 
    
	
Packaging in-process line inspection and sampling
    	
 
    	
X
    	
 
    	
 
    
	
Establish Finished product specifications (testing parameters,   acceptance criteria)
    	
 
    	
X
    	
 
    	
X
    
	
Approve Finished product specifications (testing parameters,   acceptance criteria)
    	
 
    	
X
    	
 
    	
X
    
	
Finished product test method validation
    	
 
    	
X
    	
 
    	
 
    
	
Finished product testing
    	
 
    	
X
    	
 
    	
 
    
	
Review of packaging batch documents
    	
 
    	
X
    	
 
    	
 
    
	
Release/rejection of finished goods for shipping to Upsher-Smith
    	
 
    	
X
    	
 
    	
 
    
	
Selection of carrier for shipping and shipping conditions
    	
 
    	
 
    	
 
    	
X
    
	
Preparation of shipping documents
    	
 
    	
X
    	
 
    	
 
    
	
Arrangement of shipping details (e.g., pick up)
    	
 
    	
X
    	
 
    	
 
    
	
Transmittal of complete production batch documents in accordance   with Section 18.4 of the License Agreement) (which (1) may be in   the Finnish language if USL previously was provided, and is in possession of   a current Master Batch Record, including any modifications to the Master   Batch Record, in English, and (2) if the batch documents for the first   ten (10) batches are all acceptable to USL, USL may waive the   requirement for future batch records accompanying shipments of Product as   provided in Section 18.4 of the License Agreement)
    	
 
    	
X
    	
 
    	
 
    
	
Out of specification investigation
    	
 
    	
X
    	
 
    	
 
    
	
Out of specification approval / rejection
    	
 
    	
X
    	
 
    	
X
    
	
Release of finished product for commercial distribution
    	
 
    	
 
    	
 
    	
X
    
	
Stability Testing (according to ICH and FDA requirements)
    	
 
    	
X
    	
 
    	
 
    
	
Retention of legal retain finished product samples
    	
 
    	
 
    	
 
    	
X
    
	
Retention of finished product samples for investigational   purposes
    	
 
    	
X
    	
 
    	
 
    
	
Retention of batch documents for at least 12 months after the   expiry date
    	
 
    	
X
    	
 
    	
 
    
	
Investigation of customer complaints with respect to the   following:
    	
 
    	
 
    	
 
    	
 
    
	
·       Manufacturing
    	
 
    	
X
    	
 
    	
 
    
	
·       Packaging
    	
 
    	
X
    	
 
    	
 
    
	
·       Testing   (including stability)
    	
 
    	
X
    	
 
    	
X
    
	
·       Effectiveness   of product
    	
 
    	
X
    	
 
    	
X
    
	
·       Adverse   effects
    	
 
    	
 
    	
 
    	
X
    
	
·       Reply   to complainant
    	
 
    	
 
    	
 
    	
X
    
	
Product recall
    	
 
    	
 
    	
 
    	
X
    

 

91

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
AREA OF RESPONSIBILITY
    	
 
    	
ORION
    	
 
    	
USL
    
	
Notification, in advance,   of all proposed changes to product & processes (e.g. changes in   raw/packaging materials, manufacturing processes, equipment, test   methods, etc.)
    	
 
    	
X
    	
 
    	
X
    
	
Update of relevant documents affected by changes
    	
 
    	
X
    	
 
    	
X
    
	
Audit of Orion facilities
    	
 
    	
X
    	
 
    	
X
    

 

92

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Approval Signatures

 

On behalf of Orion Corporation and Upsher-Smith Laboratories Inc., we agree to the conditions and relative responsibilities as set out in the above document.

 

	
/s/ Esko   Taskila 
    	
Risto   Hämäläinen
    	
 
    	
December 9,   2003
    
	
ORION CORPORATION
    	
Date
    
	
 
    	
 
    
	
Esko   Taskila 
    	
Risto   Hämäläinen
    	
 
    
	
Director,   Quality Assurance 
    	
Plant   Manager
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
/s/ Mark   Evenstad
    	
 
    	
November 24,   2003
    
	
UPSHER-SMITH   LABORATORIES INC.
    	
Date
    

 

93

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Appendix I

 

CONTACT LIST

 

94Exhibit 10.7

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Execution Copy

 

CIPHER PHARMACEUTICALS INC.

 

AND

 

VERTICAL PHARMACEUTICALS INC.

 

 

DISTRIBUTION AND SUPPLY AGREEMENT

 

 

AS OF JUNE 28, 2011

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

TABLE OF CONTENTS

 

	
 
    	
 
    	
 
    	
Page
    
	
1.
    	
DEFINITIONS
    	
1
    
	
 
    	
1.1
    	
“Act”
    	
1
    
	
 
    	
1.2
    	
“Active Ingredient”
    	
1
    
	
 
    	
1.3
    	
“Additional Amount”
    	
1
    
	
 
    	
1.4
    	
“Adverse Drug Event or   ADE”
    	
1
    
	
 
    	
1.5
    	
“Affiliate”
    	
2
    
	
 
    	
1.6
    	
“AG Royalty Payment”
    	
2
    
	
 
    	
1.7
    	
“Agreement”
    	
2
    
	
 
    	
1.8
    	
“Approvals”
    	
2
    
	
 
    	
1.9
    	
“Approved Manufacturer”
    	
2
    
	
 
    	
1.10
    	
“Approved Manufacturing   Site”
    	
2
    
	
 
    	
1.11
    	
“Authorities”
    	
2
    
	
 
    	
1.12
    	
“Approved Transaction”
    	
2
    
	
 
    	
1.13
    	
“Authorized Generic”
    	
2
    
	
 
    	
1.14
    	
“Business Day”
    	
2
    
	
 
    	
1.15
    	
“Cipher Indemnified   Infringement Claims”
    	
2
    
	
 
    	
1.16
    	
“Cipher Indemnitees”
    	
2
    
	
 
    	
1.17
    	
“Cipher Intellectual   Property”
    	
2
    
	
 
    	
1.18
    	
“Cipher Trademarks”
    	
2
    
	
 
    	
1.19
    	
“Commercially   Reasonable Efforts”
    	
2
    
	
 
    	
1.20
    	
“Competing Product”
    	
2
    
	
 
    	
1.21
    	
“Confidential   Information”
    	
2
    
	
 
    	
1.22
    	
“Contract Finisher”
    	
3
    
	
 
    	
1.23
    	
“Cost of Goods Sold”
    	
3
    
	
 
    	
1.24
    	
“Customer”
    	
3
    
	
 
    	
1.25
    	
“Deadline Date”
    	
3
    
	
 
    	
1.26
    	
“Dispute”
    	
3
    
	
 
    	
1.27
    	
“Distributor”
    	
3
    
	
 
    	
1.28
    	
“Distributor   Indemnified Infringement Claims”
    	
3
    
	
 
    	
1.29
    	
“Distributor   Indemnitees”
    	
3
    
	
 
    	
1.30
    	
“Effective Date”
    	
3
    
	
 
    	
1.31
    	
“FDA”
    	
3
    
	
 
    	
1.32
    	
“Firm Order”
    	
3
    
	
 
    	
1.33
    	
“First Commercial Sale”
    	
3
    
	
 
    	
1.34
    	
“Fiscal Year”
    	
3
    
	
 
    	
1.35
    	
“Force Majeure”
    	
4
    
	
 
    	
1.36
    	
“Forecast”
    	
4
    
	
 
    	
1.37
    	
“Foreign Corrupt   Practices Act”
    	
4
    
	
 
    	
1.38
    	
“Galephar”
    	
4
    
	
 
    	
1.39
    	
“Galephar License   Agreement”
    	
4
    
	
 
    	
1.40
    	
“Generic Equivalent”
    	
4
    
	
 
    	
1.41
    	
“GMP”
    	
4
    
	
 
    	
1.42
    	
“Gross Sales”
    	
4
    
	
 
    	
1.43
    	
“Healthcare Providers”
    	
4
    
	
 
    	
1.44
    	
“Indemnified Party”
    	
4
    
	
 
    	
1.45
    	
“Indemnifying Party”
    	
4
    
	
 
    	
1.46
    	
“Initial Term”
    	
4
    

 

i

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
 
    	
 
    	
Page
    
	
 
    	
1.47
    	
“Intellectual Property”
    	
4
    
	
 
    	
1.48
    	
“Law”
    	
5
    
	
 
    	
1.49
    	
“Losses”
    	
5
    
	
 
    	
1.50
    	
“Manufacture”
    	
5
    
	
 
    	
1.51
    	
“Market”
    	
5
    
	
 
    	
1.52
    	
“Marketing Plan”
    	
5
    
	
 
    	
1.53
    	
“Minimum Net Sales   Requirement”
    	
5
    
	
 
    	
1.54
    	
“Minimum Safety Stock   Level”
    	
5
    
	
 
    	
1.55
    	
“NDA”
    	
5
    
	
 
    	
1.56
    	
“Net-to-Gross Floors”
    	
5
    
	
 
    	
1.57
    	
“Net Profit”
    	
5
    
	
 
    	
1.58
    	
“Net Sales”
    	
5
    
	
 
    	
1.59
    	
“New Product”
    	
5
    
	
 
    	
1.60
    	
“Official Body”
    	
5
    
	
 
    	
1.61
    	
“Other Approvals”
    	
6
    
	
 
    	
1.62
    	
“Other Authorities”
    	
6
    
	
 
    	
1.63
    	
“P1”
    	
6
    
	
 
    	
1.64
    	
“Package”
    	
6
    
	
 
    	
1.65
    	
“Parties”
    	
6
    
	
 
    	
1.66
    	
“Person”
    	
6
    
	
 
    	
1.67
    	
“Pricing Approval”
    	
6
    
	
 
    	
1.68
    	
“Prior Forecast”
    	
6
    
	
 
    	
1.69
    	
“Product”
    	
6
    
	
 
    	
1.70
    	
“Product detail(s)”
    	
6
    
	
 
    	
1.71
    	
“Product Information”
    	
6
    
	
 
    	
1.72
    	
“Product Know-How”
    	
6
    
	
 
    	
1.73
    	
“Product Patents”
    	
7
    
	
 
    	
1.74
    	
“Product Technology”
    	
7
    
	
 
    	
1.75
    	
“Prohibitive Sales”
    	
7
    
	
 
    	
1.76
    	
“PSUR”
    	
7
    
	
 
    	
1.77
    	
“Purchase Price”
    	
7
    
	
 
    	
1.78
    	
“Recall”
    	
7
    
	
 
    	
1.79
    	
“Regulatory Approval”
    	
7
    
	
 
    	
1.80
    	
“Regulatory Authority”
    	
7
    
	
 
    	
1.81
    	
“Regulatory   Requirements”
    	
7
    
	
 
    	
1.82
    	
“Reimbursement   Approval”
    	
8
    
	
 
    	
1.83
    	
“Rejection Notice”
    	
8
    
	
 
    	
1.84
    	
“Renewal Term”
    	
8
    
	
 
    	
1.85
    	
“Responsible Person”
    	
8
    
	
 
    	
1.86
    	
“Revised Schedule”
    	
8
    
	
 
    	
1.87
    	
“Royalty Payment”
    	
8
    
	
 
    	
1.88
    	
“Rules”
    	
8
    
	
 
    	
1.89
    	
“Sales Commitment   Period”
    	
8
    
	
 
    	
1.90
    	
“Sales Milestone   Payments”
    	
8
    
	
 
    	
1.91
    	
“Scheduled Delivery   Date”
    	
8
    
	
 
    	
1.92
    	
“Schedules”
    	
8
    
	
 
    	
1.93
    	
“Second Prior Forecast”
    	
8
    
	
 
    	
1.94
    	
“Serious ADEs”
    	
8
    
	
 
    	
1.95
    	
“Specifications”
    	
8
    
	
 
    	
1.96
    	
“Stock-Out”
    	
8
    

 

ii

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
 
    	
 
    	
Page
    
	
 
    	
1.97
    	
“SubDistributors”
    	
8
    
	
 
    	
1.98
    	
“Supply Interruption”
    	
8
    
	
 
    	
1.99
    	
“Supply Interruption   End Date”
    	
9
    
	
 
    	
1.100
    	
“Tax(es)”
    	
9
    
	
 
    	
1.101
    	
“Technical Agreement”
    	
9
    
	
 
    	
1.102
    	
“Term”
    	
9
    
	
 
    	
1.103
    	
“Territory”
    	
9
    
	
 
    	
1.104
    	
“Test”
    	
9
    
	
 
    	
1.105
    	
“Third Party”
    	
9
    
	
 
    	
1.106
    	
“Trademark”
    	
9
    
	
 
    	
1.107
    	
“Unexpected ADEs”
    	
9
    
	
 
    	
1.108
    	
“Unit”
    	
9
    
	
 
    	
1.109
    	
“Up-Front Payment”
    	
9
    
	
 
    	
1.110
    	
“Wholesalers”
    	
9
    
	
 
    	
 
    	
 
    
	
2.
    	
DISTRIBUTION RIGHTS
    	
9
    
	
 
    	
2.1
    	
Exclusive   Distributorship
    	
9
    
	
 
    	
2.2
    	
Restrictions on   Marketing of Products
    	
10
    
	
 
    	
2.3
    	
Covenant Not to Market   Competing Products
    	
10
    
	
 
    	
2.4
    	
Right of First   Negotiation
    	
10
    
	
 
    	
 
    	
 
    
	
3.
    	
MARKETING
    	
10
    
	
 
    	
3.1
    	
Marketing Obligations
    	
10
    
	
 
    	
3.2
    	
Marketing Plan
    	
11
    
	
 
    	
3.3
    	
Advertising and   Promotion
    	
11
    
	
 
    	
3.4
    	
Pricing
    	
11
    
	
 
    	
3.5
    	
Information Sharing
    	
12
    
	
 
    	
3.6
    	
Reports
    	
12
    
	
 
    	
 
    	
 
    
	
4.
    	
REGULATORY MATTERS AND   PRODUCT DEVELOPMENT
    	
12
    
	
 
    	
4.1
    	
Regulatory Matters
    	
12
    
	
 
    	
4.2
    	
Technical Agreement
    	
13
    
	
 
    	
4.3
    	
Cooperation
    	
13
    
	
 
    	
4.4
    	
Finished Product
    	
13
    
	
 
    	
4.5
    	
Pediatric Clinical   Trials
    	
14
    
	
 
    	
4.6
    	
Post-Effective Date   Clinical Programs and Supplemental Approval
    	
14
    
	
 
    	
 
    	
 
    
	
5.
    	
ADES, PRODUCT QUALITY   AND PRODUCT RECALLS
    	
14
    
	
 
    	
5.1
    	
ADEs
    	
14
    
	
 
    	
5.2
    	
Product Quality   inquiries other than ADEs
    	
15
    
	
 
    	
5.3
    	
Product Recall
    	
15
    
	
 
    	
 
    	
 
    
	
6.
    	
PURCHASE PRICE AND   SUPPLY OF PRODUCTS
    	
16
    
	
 
    	
6.1
    	
Supply of Products
    	
16
    
	
 
    	
6.2
    	
Forecasts, Orders
    	
17
    
	
 
    	
 
    	
(a)
    	
Forecasts; Firm Orders
    	
17
    
	
 
    	
 
    	
(b)
    	
Purchase Orders
    	
18
    
	
 
    	
 
    	
(c)
    	
Batch Sizes
    	
18
    
	
 
    	
 
    	
(d)
    	
Satisfaction by Cipher   Affiliates and Approved Manufacturers
    	
19
    
	
 
    	
 
    	
(e)
    	
Alternative Delivery of   Forecasts and Payments
    	
19
    

 

iii

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
 
    	
 
    	
Page
    
	
 
    	
 
    	
(f)
    	
Form of Purchase   Orders
    	
19
    
	
 
    	
6.3
    	
Safety Stock
    	
19
    
	
 
    	
6.4
    	
Method of Delivery of   Product
    	
19
    
	
 
    	
6.5
    	
Title Transfer
    	
19
    
	
 
    	
6.6
    	
Continuity of Supply
    	
19
    
	
 
    	
6.7
    	
Acceptance, Rejection   and Revocation of Acceptance
    	
20
    
	
 
    	
6.8
    	
Rejection Procedures
    	
21
    
	
 
    	
6.9
    	
Prices and Payments
    	
22
    
	
 
    	
6.10
    	
Audit
    	
23
    
	
 
    	
6.11
    	
Facility Audits
    	
23
    
	
 
    	
 
    	
 
    
	
7.
    	
INTELLECTUAL PROPERTY
    	
23
    
	
 
    	
7.1
    	
Ownership of Cipher   Intellectual Property
    	
23
    
	
 
    	
7.2
    	
Ownership of   Distributor Intellectual Property
    	
24
    
	
 
    	
7.3
    	
Maintenance and   Prosecution of Product Patents
    	
24
    
	
 
    	
7.4
    	
Notice of Patent   Infringement
    	
24
    
	
 
    	
 
    	
(a)
    	
Information Concerning   Infringement
    	
24
    
	
 
    	
 
    	
(b)
    	
Potential Infringement
    	
24
    
	
 
    	
 
    	
(c)
    	
Third Party Claims;   Defense by Cipher
    	
24
    
	
 
    	
 
    	
(d)
    	
Defense by Distributor
    	
25
    
	
 
    	
 
    	
(e)
    	
Injunction
    	
25
    
	
 
    	
7.5
    	
Cipher Trademarks   Indemnified Infringement Claims
    	
25
    
	
 
    	
7.6
    	
Distributor Trademarks   Indemnified Infringement Claims
    	
25
    
	
 
    	
7.7
    	
Infringement of Product   Technology by a Third Party
    	
26
    
	
 
    	
 
    	
(a)
    	
Action by Cipher
    	
26
    
	
 
    	
 
    	
(b)
    	
Action by Distributor
    	
26
    
	
 
    	
 
    	
(c)
    	
Action by Galephar
    	
26
    
	
 
    	
7.8
    	
Trademarks
    	
26
    
	
 
    	
 
    	
(a)
    	
License
    	
26
    
	
 
    	
 
    	
(b)
    	
No Obligation to Use   Trademarks
    	
26
    
	
 
    	
 
    	
(c)
    	
Cipher Ownership
    	
27
    
	
 
    	
 
    	
(d)
    	
Distributor Ownership
    	
27
    
	
 
    	
 
    	
(e)
    	
Cipher Goodwill
    	
27
    
	
 
    	
 
    	
(f)
    	
Distributor Goodwill
    	
27
    
	
 
    	
 
    	
(g)
    	
Infringement
    	
27
    
	
 
    	
 
    	
(h)
    	
No Confusion
    	
27
    
	
 
    	
7.9
    	
Galephar’s   Acknowledgement; Distributor’s Ability to Cure
    	
28
    
	
 
    	
 
    	
 
    
	
8.
    	
CONFIDENTIALITY
    	
28
    
	
 
    	
8.1
    	
Cipher’s Information
    	
28
    
	
 
    	
8.2
    	
Distributor’s   Information
    	
28
    
	
 
    	
8.3
    	
Exceptions
    	
28
    
	
 
    	
8.4
    	
Publications
    	
28
    
	
 
    	
 
    	
 
    
	
9.
    	
TERM AND TERMINATION OF   AGREEMENT
    	
29
    
	
 
    	
9.1
    	
Term
    	
29
    
	
 
    	
9.2
    	
Termination
    	
29
    
	
 
    	
 
    	
(a)
    	
Material Breach
    	
29
    
	
 
    	
 
    	
(b)
    	
Bankruptcy and   Insolvency
    	
29
    
	
 
    	
 
    	
(c)
    	
Assignment to   Competitor
    	
29
    

 

iv

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
 
    	
 
    	
Page
    
	
 
    	
9.3
    	
Interest Payments
    	
29
    
	
 
    	
9.4
    	
Accrued Rights,   Surviving Obligations
    	
30
    
	
 
    	
9.5
    	
Transitional Matters
    	
30
    
	
 
    	
9.6
    	
Transfer of Approvals
    	
30
    
	
 
    	
9.7
    	
Effect of Termination
    	
30
    
	
 
    	
9.8
    	
Notice of Non-Renewal
    	
31
    
	
 
    	
 
    	
 
    
	
10.
    	
INDEMNITY
    	
31
    
	
 
    	
10.1
    	
Indemnification by   Cipher
    	
31
    
	
 
    	
10.2
    	
Indemnification by   Distributor
    	
31
    
	
 
    	
10.3
    	
Procedure
    	
31
    
	
 
    	
10.4
    	
Claims Related to   Active Ingredient Side Effects
    	
32
    
	
 
    	
10.5
    	
Indemnification Not   Sole Remedy
    	
32
    
	
 
    	
10.6
    	
Insurance
    	
32
    
	
 
    	
 
    	
 
    
	
11.
    	
REPRESENTATIONS,   WARRANTIES AND COVENANTS; LIMITATIONS OF LIABILITY
    	
32
    
	
 
    	
11.1
    	
Representations,   Warranties and Covenants of Both Parties
    	
32
    
	
 
    	
 
    	
(a)
    	
Organization and   Authority
    	
32
    
	
 
    	
 
    	
(b)
    	
Due Authorization and   Enforceability
    	
33
    
	
 
    	
 
    	
(c)
    	
Import and Product   Handling
    	
33
    
	
 
    	
 
    	
(d)
    	
Rights to Grant
    	
33
    
	
 
    	
 
    	
(e)
    	
Maintenance of Galephar   Licenses and Rights
    	
33
    
	
 
    	
 
    	
(f)
    	
Trademarks
    	
33
    
	
 
    	
 
    	
(g)
    	
Intellectual Property
    	
33
    
	
 
    	
 
    	
(h)
    	
No Claims
    	
34
    
	
 
    	
 
    	
(i)
    	
Notice of Default and   Amendments
    	
34
    
	
 
    	
11.2
    	
No Other Warranties
    	
34
    
	
 
    	
11.3
    	
Quality Assurance   Representations, Warranties and Covenants
    	
34
    
	
 
    	
11.4
    	
Limitation of Liability
    	
35
    
	
 
    	
 
    	
 
    
	
12.
    	
MISCELLANEOUS
    	
35
    
	
 
    	
12.1
    	
Governing Law
    	
35
    
	
 
    	
12.2
    	
Dispute Resolution
    	
35
    
	
 
    	
12.3
    	
Entire Agreement;   Amendments
    	
36
    
	
 
    	
12.4
    	
Notices
    	
36
    
	
 
    	
12.5
    	
Assignment
    	
37
    
	
 
    	
12.6
    	
Public Announcements
    	
37
    
	
 
    	
12.7
    	
Severance
    	
38
    
	
 
    	
12.8
    	
Non-Waiver
    	
38
    
	
 
    	
12.9
    	
Further Documents
    	
38
    
	
 
    	
12.10
    	
Force Majeure
    	
38
    
	
 
    	
12.11
    	
Foreign Corrupt   Practices Act
    	
38
    
	
 
    	
12.12
    	
Disclaimer of Agency
    	
38
    
	
 
    	
12.13
    	
Construction
    	
38
    
	
 
    	
12.14
    	
Counterparts
    	
39
    
	
 
    	
12.15
    	
TriGen   Laboratories, Inc.
    	
39
    

 

v

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
SCHEDULE A CIPHER TRADEMARKS
    	
 
    
	
 
    	
 
    
	
SCHEDULE B PRODUCT INFORMATION
    	
 
    
	
 
    	
 
    
	
SCHEDULE C PAYMENTS TO CIPHER
    	
 
    
	
 
    	
 
    
	
SCHEDULE D DISTRIBUTOR’S   MINIMUM NET SALES REQUIREMENT
    	
 
    
	
 
    	
 
    
	
SCHEDULE E TECHNICAL AGREEMENT
    	
 
    
	
 
    	
 
    
	
SCHEDULE F COST OF GOODS SOLD
    	
 
    
	
 
    	
 
    
	
SCHEDULE G GALEPHAR LICENSING   AGREEMENT
    	
 
    
	
 
    	
 
    
	
SCHEDULE 11.1(h) CLAIMS
    	
 
    

 

vi

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

DISTRIBUTION AND SUPPLY AGREEMENT

 

between

 

CIPHER PHARMACEUTICALS INC.

 

and

 

VERTICAL PHARMACEUTICALS INC.

 

This Distribution and Supply Agreement (the “Agreement”) is entered into as of June 28, 2011 (the “Effective Date”) by and between Cipher Pharmaceuticals Inc. (“Cipher”), an Ontario corporation located at 5650 Tomken Road Unit 16, Mississauga Ontario L4W 4P1, and Vertical Pharmaceuticals Inc. (“Distributor”), a corporation organized under the laws of the state of New Jersey with an address at 2400 Main Street, Suite 6, Sayreville, New Jersey 08872. Unless otherwise specified, all capitalized terms shall have the meaning specified in Article 1 herein.

 

RECITALS

 

1                                         Cipher has in-licensed certain know-how and intellectual property rights and obtained marketing exclusivity relating to the Product;

 

2.                                      Cipher will cause the Product to be manufactured and packaged for Distributor in the Territory;

 

3.                                      Distributor has experience in the distribution, marketing and sale of pharmaceutical products in the United States; and

 

4.                                      Cipher desires to grant Distributor and Distributor desires to accept, the right and obligation to distribute and sell Product in the Territory subject to the terms and conditions of this Agreement.

 

NOW THEREFORE THIS AGREEMENT WITNESSES THAT in consideration of the foregoing and the covenants and promises contained in this Agreement, the Parties agree as follows:

 

1.                                      DEFINITIONS

 

As used herein, the following terms shall have the following meanings:

 

1.1          “Act” means the United States Federal Food, Drug and Cosmetics Act of 1938, as amended from time to time, and all regulations, rules, guidelines and procedures promulgated thereunder.

 

1.2          “Active Ingredient” means a pharmaceutical compound which is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or function of the body.

 

1.3          “Additional Amount” shall have the meaning set forth in Section 6.2(b)(iii).

 

1.4          “Adverse Drug Event or ADE” means any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: an adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose, whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal and any failure of expected pharmacological action.

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1.5          “Affiliate” means, with respect to any Party, any other Person directly or indirectly controlling or controlled by, or under direct or indirect common control with, such Party. For purposes of this definition, a Person shall be deemed to “control” any other Person if it owns or controls a sufficient interest in the voting equity (or other comparable ownership if the other Person is not a corporation) such that it can direct, order or control the actions of such other Person. Notwithstanding this definition, Galephar shall not be considered to be an Affiliate of Cipher.

 

1.6          “AG Royalty Payment” shall have the meaning set forth in Section 6.9(e).

 

1.7          “Agreement” shall have the meaning set forth in the Preamble of this Agreement.

 

1.8          “Approvals” means collectively the Regulatory Approval and the Other Approvals.

 

1.9          “Approved Manufacturer” means Galephar, and/or a Third Party approved in advance in writing by Cipher, for the purpose of operating an Approved Manufacturing Site to Manufacture the Product.

 

1.10        “Approved Manufacturing Site” means a manufacturing site at which the Product may be Manufactured, Packaged or Tested in full compliance with the applicable Approvals and all applicable Laws and approved in advance in writing by Cipher.

 

1.11        “Authorities” means collectively the Regulatory Authority and the Other Authorities.

 

1.12        “Approved Transaction” shall have the meaning set forth in Section 8.3.

 

1.13        “Authorized Generic” shall have the meaning set forth in Section 6.9(e).

 

1.14        “Business Day” means any day other than a Saturday, a Sunday, or a day on which banks in the State of New York are required or authorized to close.

 

1.15        “Cipher Indemnified Infringement Claims” shall have the meaning set forth in Section 7.5.

 

1.16        “Cipher Indemnitees” means any of Cipher and Cipher’s Approved Manufacturers and their respective Affiliates, subsidiaries, equity holders, directors, managers, officers, employees, trustees, representatives, consultants, sublicensees, agents, successors and permitted assigns.

 

1.17        “Cipher Intellectual Property” means Intellectual Property which Cipher owns or licenses in on an exclusive basis solely in respect of the Product.

 

1.18        “Cipher Trademarks” means any trademark, whether registered or unregistered, trade name, trade dress, logo, design or associated artwork owned by or licensed to Cipher pertaining to the Product, including those listed in Schedule A.

 

1.19        “Commercially Reasonable Efforts” means exercising diligent and focused efforts in accordance with the efforts and resources that a competitive business would use for a pharmaceutical product which is of similar market potential in the Territory at a similar stage of its product life.

 

1.20        “Competing Product” means [***].

 

1.21        “Confidential Information” means all Intellectual Property and confidential facts relating to the business and affairs of a Party or any of its Affiliates, including financial information, business

 

2

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

opportunities, information relating to pharmaceutical products of any nature whatsoever, know-how, and compilations of information in any form whatsoever; provided, however, that “Confidential Information” shall not include any information that (a) was already in the public domain at the time of disclosure; (b) becomes part of the public domain through no action or omission of the receiving Party after disclosure to the receiving Party; (c) was already known to the receiving Party, other than under an obligation of confidentiality to the disclosing Party, at the time of the disclosure by the receiving Party; (d) was independently discovered or developed by the receiving Party without the use of Confidential Information belonging to the disclosing Party as shown by pre-existing proof, or (e) was disclosed to the receiving Party, other than under an obligation of confidentiality to which a Third Party was subject, by a Third Party who had no obligation to the disclosing Party not to disclose such information to others, as shown by independent proof.

 

1.22        “Contract Finisher” means a Person engaged by any of Cipher, an Approved Manufacturer or Distributor to be responsible for Packaging and/or Testing the Product in the Territory.

 

1.23        “Cost of Goods Sold” or “COGS” shall be established for each Unit, for each dosage level, according to Schedule F, and shall be adjusted on January 1 of each calendar year during the Term, commencing January I, 2012, in accordance with Schedule F.

 

1.24        “Customer” means a Person who purchases Product from Distributor and is not a SubDistributor or an Affiliate of Distributor.

 

1.25        “Deadline Date” shall have the meaning set forth in Section 6.2(b)(ii).

 

1.26        “Dispute” shall have the meaning set forth in Section 6.2(b)(ii).

 

1.27        “Distributor” shall have the meaning set forth in the first paragraph of this Agreement.

 

1.28        “Distributor Indemnified Infringement Claims” shall have the meaning set forth in Section 7.6.

 

1.29        “Distributor Indemnitees” means any of Distributor and Distributor’s SubDistributors and each of their respective Affiliates, subsidiaries, equity holders, directors, managers, officers, employees, trustees, representatives, consultants, sublicensees, agents, successors and permitted assigns.

 

1.30        “Effective Date” shall have the meaning set forth in the first paragraph of this Agreement.

 

1.31        “FDA” means the United States Food and Drug Administration or any successor agency which issues a Regulatory Approval for the Marketing of the Product in the United States.

 

1.32        “Firm Order” shall have the meaning set forth in Section 6.2(a)(i).

 

1.33        “First Commercial Sale” means the earlier of (i) first arm’s length sale of Product by Distributor, its Affiliates or SubDistributors to a Third Party in the Territory, as evidenced by delivery of the Product to the Third Party, or (ii) thirty (30) days after the transfer of title set forth in Section 6.5 of this Agreement..

 

1.34        “Fiscal Year” means the twelve (12) months ending after the First Commercial Sale. “Fiscal Year 2”, “Fiscal Year 3”, and “Fiscal Year 4” shall have the meanings as set forth in Schedule D.

 

3

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1.35        “Force Majeure” means an event or circumstances beyond the reasonable control of a Party or Approved Manufacturer or Contract Finisher and without the fault or negligence of the affected Party or their Approved Manufacturer or Contract Finisher, including acts of God, acts of the public enemy, fire, explosion, flood, draught, terrorism, sabotage, embargo, government restrictions, wars, insurrections, failure of suppliers, subcontractors and carriers, strikcs, labour disputes, failures of electricity supply and inability to obtain essential ingredients or supplies (for the avoidance of doubt, the Parties agree that the failure of any Approved Manufacturer or a Contract Finisher to supply Cipher shall not be deemed a Force Majeure with respect to Cipher except to the extent such failure to supply is the direct result of a Force Majeure applicable to such Approved Manufacturer or such Contract Finisher).

 

1.36        “Forecast” shall have the meaning set forth in Section 6.2(a)(i).

 

1.37        “Foreign Corrupt Practices Act” shall have the meaning set forth in Section 12.11.

 

1.38        “Galephar” means Galephar Pharmaceutical Research Inc. and its successors and assigns.

 

1.39        “Galephar License Agreement” means the Master Licensing and Clinical Supply Agreement effective February, 2002 between Cipher and Galephar, as amended, a redacted copy of which is attached hereto as Schedule G.

 

1.40        “Generic Equivalent” means a product approved by the FDA as a therapeutically equivalent and substitutable product (AB rated product) to the Product pursuant to the FDA’s ANDA process.

 

1.41        “GMP” means at any time the quality systems and good manufacturing practices as set forth in 21 C.F.R. (Parts 210 and 211) and any other applicable Laws, directives, rules, regulations, guides and guidance in existence in the Territory at that time.

 

1.42        “Gross Sales” means the aggregate gross amounts invoiced by Distributor, its Affiliates or SubDistributors in connection with sales of the Product to Customers in bona fide, arm’s length transactions, (excluding sales of Distributor to its SubDistributors or Affiliates) in the Territory for use in the Territory.

 

1.43        “Healthcare Providers” means physicians, nurse practitioners and physician assistants, but only to the extent such persons have sole authority to prescribe the Product.

 

1.44        “Indemnified Party” shall have the meaning set forth in Section 10.3.

 

1.45        “Indemnifying Party” shall have the meaning set forth in Section 10.3.

 

1.46        “Initial Term” shall have the meaning set forth in Section 9.1.

 

1.47        “Intellectual Property” means all patents (including the Product Patents), copyrights, trademarks, service marks, service names, trade names, internet domain names, e-mail addresses, applications or registrations for any of the foregoing, or extensions, renewals, continuations or re-issues thereof, or amendments or modifications thereto, brandmarks, brand names, trade dress, labels, logos, know-how (including the Product Know-How), show-how, technical and non-technical information, trade secrets, formulae, techniques, sketches, drawings, models, inventions, designs, specifications, processes, apparatus, equipment, databases, research, experimental work, development, pharmacology and clinical data, software programs and applications, software source documents, Third-Party licenses, and any similar type of proprietary intellectual property right vesting in the owner and/or licensee thereof pursuant to the

 

4

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

applicable Laws of any relevant jurisdiction or under any applicable license or contract, whether now existing or hereafter created, together with all modifications, enhancements and improvements thereto.

 

1.48        “Law” means all laws, statutes, ordinances, decrees, judgments, codes, standards, acts, orders, by-laws, rules, regulations, permits, legally binding policies and guidelines and legally binding requirements of all Authorities including the Act and the Federal Controlled Substances Act, including all amendments thereto, and all regulations, rules, guidelines and procedures promulgated thereunder, as well as analogous legislation in the remainder of the Territory.

 

1.49        “Losses” shall have the meaning set forth in Section 10.1.

 

1.50        “Manufacture” means to make the Product in compliance with GMP, including to process, prepare, make and Test the raw materials used in the preparation of the Product and to Test the Product prior to release for Packaging, in each case in a finished dosage form ready for administration to humans or animals and “Manufactured” and “Manufacturing” have a corresponding meaning.

 

1.51        “Market” means to promote, advertise, distribute, market, and/or sell for purposes of a commercial sale, and “Marketing” has a corresponding meaning.

 

1.52        “Marketing Plan” shall have the meaning set forth in Section 3.2.

 

1.53        “Minimum Net Sales Requirement” means the minimum annual net sales as outlined in Schedule D.

 

1.54        “Minimum Safety Stock Level” shall have the meaning set forth in Section 6.3.

 

1.55        “NDA” means the Regulatory Approval held by Cipher to Market the Product (FDA NDA 22-370) and shall include all accompanying data and information including supplements and amendments submitted by Cipher to a Regulatory Authority in connection with such NDA.

 

1.56        “Net-to-Gross Floors” shall have the meaning set forth in Schedule C.

 

1.57        “Net Profit” means Net Sales minus the Cost of Goods Sold.

 

1.58        “Net Sales” means, for any period, Gross Sales less any and all (a) credits or allowances actually granted for damaged Product, returns or rejections of Product, chargebacks, price adjustments and billing errors; (b) governmental and other rebates, patient vouchers or coupons (or equivalents thereof) granted to managed health care organizations; pharmacy benefit managers (or equivalents thereof); federal, state/provincial, local and other governments, their agencies and purchasers and reimbursers; or to Customers; (c) normal and customary trade, cash and quantity discounts, allowances and credits; (d) distribution services agreement fees allowed or paid to third party distributors; (e) sales taxes, VAT and other taxes applied to the sale of Product to the extent included in the gross amount invoiced; and (f) any other mutually agreed items that reduce Gross Sales amounts as required by generally accepted accounting principles in the United States applied on a consistent basis.

 

1.59        “New Product” shall have a meaning as set forth in Section 2.4.

 

1.60        “Official Body” means any national, federal, state, provincial or local government or government of any subdivision thereof, or any parliament, legislature, council, agency, authority, board, commission, department, bureau or instrumentality thereof, or any court, tribunal, grand jury, mediator or arbitrator, whether foreign or domestic, in each case having jurisdiction in the relevant circumstances.

 

5

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1.61        “Other Approvals” means, for the Product, the approval or authorization granted by the Other Authorities for the Marketing of the Product in the Territory, including the Pricing Approval and the Reimbursement Approval, as applicable.

 

1.62        “Other Authorities” means Official Bodies (other than the Regulatory Authority) whose approval is required by applicable Law to Market and/or obtain reimbursement for the Product in a jurisdiction in the Territory.

 

1.63        “P1” means a first position Product detail (primary emphasis, which constitutes a majority of the time expended on a call); and “P2” means a second position Product detail (secondary emphasis, which constitutes less time than a P1 detail but more time than any other product promoted during a call other than a PI product).

 

1.64        “Package” means to package and label the Product for Marketing and “Packaging” has a corresponding meaning.

 

1.65        “Parties” means Cipher and Distributor, and “Party” shall mean either of Cipher or Distributor, as the context requires.

 

1.66        “Person” means any individual, partnership, limited partnership, joint venture, syndicate, sole proprietorship, company or corporation with or without share capital, unincorporated association, trust, trustee, executor, administrator or other legal personal representative or other entity or Official Body.

 

1.67        “Pricing Approval” means any approval or authorization of any Official Body establishing prices for the Product in a jurisdiction in the Territory.

 

1.68        “Prior Forecast” shall have the meaning set forth in Section 6.2(a)(i).

 

1.69        “Product” means a pharmaceutical product in final finished Packaged form for use in humans, composed of a capsule containing tramadol as the only Active Ingredient and meeting the Specifications as described in further detail within the NDA as the same may be amended or supplemented. “Product” includes the following dosage strengths: 100 mg; 200 mg; 300 mg and also includes any additional dosage strengths of the formulation approved by FDA under the NDA.

 

1.70        “Product detail(s)” means a face-to-face meeting, between a professional sales representative of Distributor and a health care professional with prescribing authority, during which a presentation of the Product’s attributes is orally presented in a manner consistent with the quality of such presentations made by Distributor’s professional representatives for such Distributor’s other products.

 

1.71        “Product Information” means all in-vivo or clinical, pharmacology, toxicology, safety and efficacy data, stability data, formulary submissions, pharmaco-economic data, and other such information now or hereafter known and available to Distributor or Cipher or their respective Affiliates, SubDistributors or Approved Manufacturer(s) or their Affiliates, whether generally known to others or not.

 

1.72        “Product Know-How” means the data, information, expertise, trade secrets, manufacturing, mixing and production procedures, technical assistance, and shop rights, known to or in the possession of Cipher, its Affiliates or any Approved Manufacturer(s) or its Affiliates, whether generally known to others or not, and relating to the Manufacturing, Packaging, Marketing and/or Testing of the Product, including:

 

6

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

(a)           characteristics, selection of properties and data relating to materials, such as excipients, used or useful in the Manufacturing, Packaging and/or Testing of the Product;

 

(b)           techniques, equipment and methods used or useful in the Manufacturing, Packaging or Testing of the Product;

 

(c)           equipment and data relating to the Manufacturing, Packaging or Testing of the Product; and

 

(d)           all in vivo or clinical, pharmacology, toxicology, safety and efficacy data, formulary submissions, pharmaco-economic data, and other such information useful or required in preparing applications for or obtaining or maintaining Regulatory Approval and/or for the Manufacturing, Packaging, Marketing and/or Testing of the Product.

 

1.73        “Product Patents” means all patents owned by or licensed to Galephar, and for which Cipher or any of its Affiliates has a license from Galephar, (i) which have issued as of the Effective Date or (ii) which issue at any time from applications pending as of the Effective Date, or from applications subsequently filed during the Term of this Agreement, which (in the case of both (i) and (ii)) claim inventions necessary or useful for the Manufacture, use, import or Marketing of the Product, including any continuation, division, continuation-in-part, and any provisional applications, and which patents have not expired or been held invalid or unenforceable by a court of competent jurisdiction in a final, non-appealable decision, including all substitutions, extensions, registrations, confirmations, re-examinations, reissues or renewals of such patents. Schedule B lists, as of the Effective Date, all such Patents that have issued and pending applications and Schedule B shall be amended from time to time to include patents or applications owned by or licensed to Galephar and licensed to Cipher or one or more of its Affiliates to the extent they claim inventions necessary or useful for Manufacturing, use, import, or Marketing of the Product within the Territory or an amendment to any Product Patents.

 

1.74        “Product Technology” means collectively Product Know-flow and Product Patents.

 

1.75        “Prohibitive Sales” shall have the meaning set forth in Section 2.1(a).

 

1.76        “PSUR” shall have the meaning set forth in Section 4.1(a).

 

1.77        “Purchase Price” at any time means an amount equal to the Product Cost of Goods Sold.

 

1.78        “Recall” shall have the meaning set forth in Section 5.3(a) and “Recalled” has a corresponding meaning.

 

1.79        “Regulatory Approval” means the approval or authorization granted by a Regulatory Authority for the Marketing of the Product in the Territory.

 

1.80        “Regulatory Authority” means the FDA, and/or any equivalent, similar or successor Official Body, whose approval is required by applicable Law to Market, Manufacture, Test and/or Package the Product in any jurisdiction which forms part of the Territory.

 

1.81        “Regulatory Requirements” means all applicable Regulatory Approvals, licenses, registrations, GMPs, and authorizations and all other requirements of any applicable Regulatory Authorities in relation to the Product, including each of the foregoing which is necessary for, or otherwise governs, the Manufacture, Marketing, Packaging and Testing of Product in the Territory.

 

7

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1.82        “Reimbursement Approval” means any approval or authorization of any Official Body establishing a health insurance or drug reimbursement scheme for the Product in a jurisdiction in the Territory.

 

1.83        “Rejection Notice” shall have the meaning set forth in Section 6.7(b).

 

1.84        “Renewal Term” shall have the meaning set forth in Section 9.1.

 

1.85        “Responsible Person” shall have the meaning set forth in Section 12.2.

 

1.86        “Revised Schedule” shall have the meaning set forth in Section 6.2(b)(iii).

 

1.87        “Royalty Payment” means the royalty payment, as set forth in Schedule C.

 

1.88        “Rules” shall have the meaning set forth in Section 12.2.

 

1.89        “Sales Commitment Period” means the [***] following the quarter in which the First Commercial Sale occurs.

 

1.90        “Sales Milestone Payments” means the sales milestone payments as set forth in Schedule C.

 

1.91        “Scheduled Delivery Date” shall have the meaning set forth in Section 6.6(c).

 

1.92        “Schedules” means the following Schedules to this Agreement (as the same may be amended from time to time in accordance with this Agreement):

 

Schedule A — Cipher Trademarks

Schedule B — Product Information

Schedule C — Payments to Cipher

Schedule D — Distributor’s Minimum Net Sales Requirement

Schedule E — Technical Agreement

Schedule F — Cost of Goods Sold

Schedule G — Galephar Licensing Agreement (redacted)

Schedule 1 1.1(h) — Claims

 

1.93        “Second Prior Forecast” shall have the meaning set forth in Section 6.2(a)(i).

 

1.94        “Serious ADEs” shall have the meaning set forth in Section 5.1.

 

1.95        “Specifications” means the specifications of the Product as set forth as part of the Technical Agreement attached in Schedule F, and the quality assurance provisions of Section 11.3 hereto.

 

1.96        “Stock-Out” shall have the meaning set forth in Section 6.6(c).

 

1.97        “SubDistributors” means Third Parties retained by Distributor pursuant to Section 2.1(d) to Market the Product in the Territory as a contract sales force, and shall exclude, without limitation, wholesalers, retailers, hospitals, government purchasers, managed care organizations and permitted sublicensees.

 

1.98        “Supply Interruption” shall have the meaning set forth in Section 6.6(c).

 

8

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1.99        “Supply Interruption End Date” shall have the meaning set forth in Section 6.6(c).

 

1.100      “Tax(es)” means, with respect to Distributor, all federal, state, local, county, foreign and other taxes or government charges constituting sales, use, transfer, value added, customs, duty or excise taxes payable by Distributor in connection with the importation or sale of Product.

 

1.101      “Technical Agreement” shall have the meaning specified in Section 4.2.

 

1.102      “Term” shall have the meaning set forth in Section 9.1.

 

1.103      “Territory” shall mean the U.S. and all of its territories and possessions, excluding Puerto Rico and the U.S. Virgin Islands.

 

1.104      “Test” means to test a product or its ingredients prior to release for further processing or for shipping and Marketing in compliance with applicable Law and “Tested” and “Testing” has the corresponding meaning.

 

1.105      “Third Party” means any Person other than Cipher, Distributor or their respective Affiliates.

 

1.106      “Trademark” means any trademark, trade name, trade dress, logo, design or associated artwork selected, owned and/or used by Distributor or its Affiliates pertaining to the Product, other than the Cipher Trademarks.

 

1.107      “Unexpected ADEs” shall have the meaning set forth in Section 5.1.

 

1.108      “Unit” means a single capsule of the Product, regardless of dosage strength.

 

1.109      “Up-Front Payment” means the up-front payment, as set forth in Schedule C.

 

1.110      “Wholesalers” when capitalized means McKesson Corp., Cardinal Health Inc. and Americansourcebergen Corp. or their Affiliates.

 

2.                                      DISTRIBUTION RIGHTS

 

2.1          Exclusive Distributorship.

 

(a)           Upon and subject to the terms and conditions of this Agreement, Cipher hereby appoints Distributor as its exclusive distributor of the Product in the Territory throughout the Term with the exclusive right and obligation to Market the Product in the Territory and the right to conduct post-regulatory approval clinical program development for the Product pursuant to Section 4.6, and Distributor hereby accepts such appointment. Cipher represents and warrants to Distributor that except for the exclusive license granted in this Section 2.1, Cipher has not granted any other license to use, market and/or import, the Product in the Territory. Cipher shall take all reasonable and prudent actions to ensure that Product does not enter the Territory as black market goods, and shall include in any contracts with distributors outside the Territory terms and conditions (i) that prohibit the export of Product into the Territory, and (ii) that (A) prohibit the sale of Product to Third Parties known to participate in the export in the Territory of Product or of a product with the same formulation and range of strengths as the Product, as approved by the Regulatory Authorities from time to time (“Prohibited Sales”) or/and (B) permit Cipher to terminate the contract if Distributor does not cure Prohibited Sales.

 

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(b)           To the extent required by Distributor to Market the Product in accordance with this Agreement, Cipher hereby grants to Distributor a non-exclusive license to use all Product Technology necessary in order to Market the Product in the Territory.

 

(c)           Distributor shall obtain exclusively from Cipher all Product for Marketing in the Territory, except as otherwise permitted by the terms of this Agreement. Cipher shall supply the Product to Distributor for Marketing by Distributor in the Territory in accordance with the terms of this Agreement.

 

(d)           Distributor shall have the right to retain SubDistributors to Market the Product for use solely within the Territory, and Distributor shall cause such SubDistributors to perform the applicable obligations of Distributor under this Agreement, or otherwise ensure that such obligations are performed by Distributor, provided that nothing herein shall imply a right of Distributor to grant a sublicense to a SubDistributor other than pursuant to Section 2.1(e) below. Distributor shall remain fully responsible and liable to Cipher for the performance of all of the terms of this Agreement by its SubDistributors. Distributor shall not he entitled to retain as a SubDistributor any Person which is engaged in, directly or indirectly, developing or Marketing any Competing Product in the Territory.

 

(e)           Except as otherwise expressly provided herein, Distributor shall have no right to sublicense any rights granted under this Agreement, without prior written consent of Cipher.

 

2.2          Restrictions on Marketing of Products. From and after the Effective Date, Distributor shall not, and shall cause its Affiliates and SubDistributors to not, Market the Product outside the Territory, or Market the Product to any Person who, to the knowledge of any of Distributor, its SubDistributors, or its Affiliates, intends to Market such Product outside the Territory.

 

2.3          Covenant Not to Market Competing Products. From and after the Effective Date until the earlier of (i) the termination of this Agreement, or (ii) a Generic Equivalent becomes available for sale in the Territory, Distributor shall not, and shall cause its Affiliates and SubDistributors to not, Market a Competing Product, other than a Cipher-supplied Authorized Generic, in the Territory.

 

2.4          Right of First Negotiation. In the event Cipher develops and obtains Regulatory Approvals for any improvement or reformulation of the Product, or any new product containing Tramadol as an Active Ingredient that competes with the Product (in either case, a “New Product”), assuming the Agreement has not been terminated or Distributor is not in material breach of the Agreement, Cipher shall offer Distributor the first right to negotiate for the exclusive right to sell, market and distribute such New Product in the Territory. Cipher shall negotiate in good faith exclusively with Distributor for a period of 120 days to reach a definitive agreement with respect to such distribution rights.

 

3.                                      MARKETING

 

3.1          Marketing Obligations. Distributor will, at its sole cost and using Commercially Reasonable Efforts, Market the Product in the Territory throughout the Term of the Agreement. Without limiting the foregoing, Distributor shall (i) deliver a minimum of [***] sales force Product details per quarter during the Sales Commitment Period, (ii) promote the Product in a P1 detail position during the first [***] of the Sales Commitment Period, (iii) promote the Product in a P1 or P2 detail position during the remaining [***] of the Sales Commitment Period, (iv) employ a minimum of [***] salespersons to detail the Product on a full-time basis throughout the Sales Commitment Period of the Agreement, provided, however, that if one or two vacancies occur, Distributor will use good faith efforts to fill such vacancy or vacancies in a timely manner, provided that in no event shall there be less than [***] salespersons that detail the Product on a full-time basis at any time, and (v) use good faith efforts to ensure that its salespersons incentive compensation plan corresponds to and reflects the detailing position of the Product, including ensuring that

 

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the Product shall represent the highest percent targeted payout of any product or group of products (including the multivitamin group) in Distributor’s incentive compensation plan for the first [***] of the Sales Commitment Period and not less than any other product or group of products (including the multivitamin group) in Distributor’s incentive compensation plan during the remaining [***] of the Sales Commitment Period, provided, however, that in no event shall such quarterly incentive compensation payments for the Product as a percentage of total compensation payments to the sales force be less than [***] during the first [***] of the Sales Commitment Period or less than [***] thereafter until the end of the Sales Commitment Period. Distributor shall also be subject to the Minimum Net Sales Requirements set forth in Schedule D. The obligations under this Section 3.1 shall terminate if a Generic Equivalent of a Third Party becomes available in the Territory.

 

3.2          Marketing Plan. Distributor will be responsible for assessing the market opportunities for the Product in the Territory and preparing and providing to Cipher, by August 10 2011, a marketing plan for the Product (“Marketing Plan”) which Marketing Plan shall set forth Distributor’s plan, strategy and proposed activities consistent with efforts appropriate for pharmaceuticals products of similar market potential to market the Product in the Territory. The Marketing Plan will include as appropriate without limitation, the following elements,

 

(i)            a description of Distributor’s general strategy with respect to pre¬launch and post-launch marketing, reimbursement strategies, sales aids, advertising and promotion activities including sampling and detailing of the Product in the Territory;

 

(ii)           an estimated time schedule for the performance of the Marketing Activities;

 

(iii)          a description of the personnel resources of Distributor that will perform the Marketing Activities, including the number of sales representatives and physician calls; and

 

(iv)          a description of Distributor’s pricing strategy in the Territory.

 

Thereafter, Distributor shall, on or before November 1st in each year of the Term provide Cipher with a copy of Distributor’s Marketing Plan for the next calendar year. Cipher may communicate comments to Distributor in respect of such Marketing Plans. Distributor agrees to consider such comments and shall provide a response to Cipher in respect of such comments, which response may include revisions to the Marketing Plan. Notwithstanding the foregoing, Distributor shall determine the Marketing Plan and will be responsible for its implementation and shall use best efforts to achieve the objectives specified therein.

 

3.3          Advertising and Promotion. Distributor shall provide to Cipher copies of the materials relating to the Marketing of the Product including print advertising, brochures, leaflets and similar materials at the same time(s) that Distributor files the foregoing with Regulatory Authorities in the Territory. All such materials shall comply in all material respects with applicable Laws and requirements of any applicable Regulatory Authority. Distributor shall not, in its Marketing materials, make any therapeutic claims or statements relating to the Product other than those supplied by Cipher and authorized by the applicable Regulatory Authorities, and Distributor shall remain solely liable for all Marketing materials prepared by it.

 

3.4          Pricing. Distributor shall have final decision for Product pricing and other Marketing terms. Notwithstanding the foregoing, in the event that Distributor sells or offers for sale any dosage strength of the Product with other products of Distributor, its Affiliates, or SubDistributors at a price that is reduced or discounted from the normal selling price for that dosage strength of the Product by a percentage that is greater than that offered on such other products, and if that discount is only available with or is

 

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conditioned upon the purchase of such other products, Distributor shall calculate the Net Selling Price of the Product and adjust the Net Sales as if the discount or reduction had been applied equally to all of the products sold or offered for sale in combination.

 

3.5          Information Sharing. Cipher shall provide to Distributor such Product Information that may be useful or that Distributor requires in preparing applications for or obtaining any Other Approvals and/or in the Marketing of the Product within the Territory, or in obtaining formulary listings or acceptance or approval of the Product by customers, potential customers, or buying agents or groups within the Territory. Distributor shall, and shall require its Affiliates and SubDistributors to, promptly provide to Cipher all Product Information that comes into its possession and all information relating to the Marketing or use of the Product.

 

3.6          Reports.

 

(a)           Each Party shall promptly keep the other fully informed of all governmental and regulatory requirements, activities and plans of any Regulatory Authority including any changes thereto of which such Party becomes aware which materially affect, or are reasonably likely to materially affect, sales of the Product in the Territory.

 

(b)           Prior to the First Commercial Sale of the Product, Distributor shall at the reasonable request of Cipher, report to Cipher regarding Distributor’s pre-launch Marketing activities with respect to the Product as set forth in the Marketing Plan prepared pursuant to Section 3.2.

 

(c)           After the First Commercial Sale of the Product, Distributor shall, throughout the Term, provide to Cipher the quarterly statements accompanying each Royalty Payment as provided in Part D of Schedule C hereto.

 

(d)           After the First Commercial Sale of the Product, Distributor shall provide to Cipher (i) on a calendar quarter basis on or before the last business day of the succeeding month, a report detailing (A) the number of calls to Healthcare Providers, including a breakout of PI and/or P2 calls, (B) the number of salespersons detailing the Product, and (C) the budget and spend on marketing, advertising and promotion activities compared to the Marketing Plan and (ii) within sixty (60) days of the end of each calendar quarter, a report as to Product bonus payments to salespersons on an aggregate basis as a percentage of total bonus or incentive payments, in each case prepared in a manner consistent with Distributor’s internal reporting methods.

 

(e)           After the First Commercial Sale of the Product, Distributor shall on a calendar quarter basis provide on or before the last business day of the succeeding month, a report summarizing the status of Other Approvals and filings in terms of formulary listings and Reimbursement Approvals, if any, for each listing if applicable.

 

4.                                      REGULATORY MATTERS AND PRODUCT DEVELOPMENT

 

4.1          Regulatory Matters.

 

(a)           Cipher shall be responsible for (i)matters relating to the maintenance of the Regulatory Approvals for the Product, including compliance with all Regulatory Requirements and otherwise keeping the Product NDA in force, and (ii) all communications with the Regulatory Authorities associated with the Product NDA including all ADE reporting and periodic safety update reporting (“PSUR”). Distributor shall be responsible for providing on a timely basis all necessary documentation needed for all regulatory filings relating to the Marketing of the Product in the Territory with the Regulatory

 

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Authority, including all pharmacovigilance data needed for PSUR. Notwithstanding the foregoing, Distributor will be responsible for pharmacovigilance spontaneous reporting to the Regulatory Authority with a copy to Cipher and Distributor will provide information necessary for submission by Cipher to the Regulatory Authorities.

 

(b)           Distributor shall he responsible for all remaining pharmacovigilance activities in the Territory, including receiving, monitoring, responding promptly to, tracking, or as may otherwise be required by applicable Law and Regulatory Authority, all Product-related inquiries, Product quality complaints, and ADE reports received by Distributor, its Affiliates or SubDistributors or by Cipher (and which Cipher shall have forwarded to Distributor) from individuals and/or health care professionals from within the Territory.

 

(c)           All communications by either Party with the Regulatory Authority in each jurisdiction in the Territory relating to the Product as Marketed in the Territory shall on a timely basis be provided in writing to the other Party, and each Party shall provide on a timely basis to the other Party (i) copies of all documents sent to or received from the Regulatory Authority regarding the Product and the NDA and (ii) notice of any proposed calls or meetings with a Regulatory Authority relating to the Product or NDA. Cipher shall provide an opportunity to discuss with Distributor topics relevant to such calls and meetings and consider in good faith Distributor’s interest with regard to such matters.

 

(d)           [***] shall be responsible for Prescription Drug User Fees for the Product (excluding establishment fees) associated with the maintenance of Regulatory Approval of the Product during the Term, commencing with the 2011 fiscal year (October 1st 2010 through September 30, 2011) and, if applicable, shall reimburse [***] for any such Prescription Drug User Fees for the Product paid by [***] with respect to any fiscal year within [***] days of receiving an invoice from [***]. Notwithstanding the foregoing, provided the [***] is made to [***] by no later than June 30, 2011, [***] may postpone reimbursement of the Prescription Drug User Fees for the 2011 fiscal year until the earlier of thirty (30) after the First Commercial Sale, or September 30, 2011. [***] shall be responsible for Prescription Drug User Fees for the Product, if any, for fiscal years prior to the 2011 fiscal year. [***] shall also be solely responsible for establishment fees related to the manufacture of the Product to the extent it is responsible for manufacturing the Product.

 

(e)           Distributor shall be responsible for all matters relating to the Other Approvals for the Product including filing the Product with, maintaining the Product on and dealing with, any federal, state, or private formularies. Distributor will apply for and will hold the Other Approvals in Distributor’s name at all times for the benefit of Cipher. Distributor shall be responsible for all regulatory filings relating to the Product with the Other Authorities.

 

4.2          Technical Agreement. Concurrently with the execution of this Agreement, the Parties shall execute a technical and quality agreement that appropriately addresses each Party’s responsibilities as they relate to Manufacturing, storage, distribution, regulatory, operational, Testing and quality issues regarding the Product in the form attached hereto as Schedule E (as such technical and quality agreement may be amended from time to time during the Term by mutual agreement of the Parties or to conform to requirements of applicable Law) (the “Technical Agreement”).

 

4.3          Cooperation. Each of Cipher and Distributor shall provide to the other or if applicable, directly to the Authorities, any assistance and all documents reasonably necessary to enable the other to carry out its obligations under this Article 4, at its own cost and expense.

 

4.4          Finished Product. Cipher shall Manufacture, Test and release finished Product in accordance with the Regulatory Requirements at Cipher’s sole cost and expense, any additional Tests that

 

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Distributor may require to ensure the quality of the incoming goods shall be conducted by Distributor at Distributor’s sole cost and expense. Distributor shall be responsible for contracting for and providing ongoing, appropriate oversight as to compliance with Regulatory Approvals and applicable Law of finished Product and Product sample Packaging.

 

4.5          Pediatric Clinical Trials. In the event that the Regulatory Authorities require a pediatric clinical trial to be conducted with respect to the Product, subject to the input by Distributor, Cipher shall he responsible for conducting such pediatric clinical trial, and submitting appropriate filings with the Regulatory Authorities. All Third Party out-of-pocket costs incurred by Cipher in the conduct of such pediatric clinical trial shall be [***] between the Parties (it being understood that Cipher shall pay such out-of-pocket costs and thereafter be reimbursed by Distributor for [***] thereof on a monthly basis within ten (10) business days of receiving an invoice and supporting details for such out-of-pocket costs. Notwithstanding the foregoing, if the requirement for a pediatric clinical trial can be achieved through alternative means approved by the Parties, including funding an existing Third Party tramadol ER pediatric study, all fees and costs paid to such Third Party by Cipher in connection therewith shall be [***] between the Parties (it being understood that Cipher shall pay such fees and costs and thereafter be reimbursed by Distributor for [***] thereof on a monthly basis with ten (10) business days after receiving an invoice with supporting details for such out-of-pocket costs.

 

4.6          Post-Effective Date Clinical Programs and Supplemental Approval. Except as otherwise provided in Section 4.5, after the Effective Date, Distributor shall be responsible at its sole cost and expense for conducting any clinical Testing that Distributor chooses to conduct, if any, at its sole choice and discretion, for the continued and successful Marketing of the Product in the Territory as well as the associated regulatory costs. Distributor shall provide any clinical protocols at least forty-five (45) days before such clinical work begins for Cipher’s review and approval, which shall not be unreasonably withheld, conditioned or delayed. Cipher shall provide any comments or approval within fifteen (15) days so that Distributor can implement an approved clinical protocol without undue delay. To the extent Cipher, in its sole discretion, believes it would be beneficial to conduct certain post-regulatory approval clinical Testing, and Distributor does not wish to undertake such Testing, Cipher shall be free to undertake such Testing at its own cost and expense; provided, however, that prior to Cipher undertaking such Tests, the Parties will negotiate in good faith additional consideration to be paid to Cipher in the event such Testing results in successful outcomes.

 

5.                                      ADES, PRODUCT QUALITY AND PRODUCT RECALLS

 

5.1          ADEs. Each of Cipher and Distributor and their respective Affiliates, SubDistributors, Approved Manufacturers, agents or other relevant parties shall inform the other of all known or suspected ADE’s associated with the Product in the Territory, of which it is notified, or otherwise becomes aware, as soon as reasonably possible but in any event quarterly for ADE’s and within seven (7) days for Serious ADEs and Unexpected ADE’s or within any time limits required by applicable Law, whichever is shorter. “Serious ADEs” means, any adverse drug event occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse. “Unexpected ADEs” means, any adverse drug event that is not listed in the current labeling for the Product. This includes events that may be symptomatically and pathophysiologically related to an event listed in the labelling, but differ

 

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from the event because of greater severity or specificity. The roles and responsibilities of each Party in respect of ADE’s shall be specified in the Technical Agreement attached as Schedule E.

 

5.2          Product Quality inquiries other than ADEs.

 

(a)           Each Party shall submit to the other Party, within three (3) Business Days of receipt any complaints regarding Product quality (other than ADEs) received by that Party or any of its Affiliates or, in the case of Distributor, its SubDistributors, to which that Party must respond, together with all evidence then available and all other information relating thereto subsequently obtained or produced by either Party.

 

(b)           Cipher shall respond, in writing (including by facsimile or email) or by telephone, to inquiries made by Distributor relating to the Manufacturing or if applicable Packaging of the Product within fourteen (14) Business Days of receipt of the inquiry and shall provide Distributor with such information as Distributor may reasonably require addressing the inquiry.

 

(c)           Each of Distributor and Cipher shall promptly notify the other of any notice of non-compliance with any Laws applicable to the Product or the Packaging of the Product, received from any Regulatory Authority having jurisdiction in the Territory, and of any request for or initiation of any inspection of any facility of either Cipher or Distributor, or any Affiliate of Cipher or Distributor, or any Approved Manufacturer, or Contract Finisher that Manufactures, Packages, Tests or stores any Product.

 

(d)           Each of Cipher and Distributor shall provide to each other in a timely manner all information which the other Party reasonably requests regarding the Product in order to enable the other Party to comply with all Laws applicable to the Product in the Territory and in order to enable Cipher to comply with all Laws applicable to the Product outside the Territory.

 

5.3          Product Recall.

 

(a)           Distributor will maintain or cause to be maintained such traceability records as are necessary to permit a recall, market withdrawal or field correction of the Product, including inventory withdrawal in connection with any of the foregoing (each a “Recall”).

 

(b)           Each Party shall promptly (but in any case, not later than twenty-four (24) hours of receipt) notify the other Party in writing of any information which indicates a Recall of any Product may be necessary, any safety or regulatory concerns, or any order, request or directive of a court or other Regulatory Authority requesting or requiring a Recall.

 

(c)           To the extent permitted by circumstances, the Parties will confer before initiating any Recall. If the Parties do not agree on the need for or the extent of such a Recall, either Party may authorize the Recall.

 

(d)           Each Party will cooperate fully with the other Party in connection with any Recall efforts.

 

(e)           Distributor shall be responsible for the carrying out of any and all Recalls in accordance with applicable Laws.

 

(f)            If any Recall is required (I) due to the failure of the Product to conform to the Specifications at the time title is transferred to Distributor, as subsequently confirmed by a mutually acceptable Third Party laboratory, or (II) due to the fact that Product samples (both retention and stability)

 

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stored under controlled conditions at the time of title transfer to Distributor no longer conform to the Specifications at any time tested thereafter until the Product expiration date is reached as confirmed by Cipher or its Approved Manufacturer (for stability samples) or a mutually acceptable Third Party laboratory (for retention samples), Cipher will be responsible for the direct costs of such Recall, will reimburse Distributor, its Affiliates, and SubDistributors within ten (10) Business Days after receipt of an invoice with supporting detail for all of their direct out-of-pocket costs and direct expenses related to such Recall. Any Minimum Net Sales Requirements set forth in Schedule D and promotional commitments in Section 3.1 shall be held in abeyance during such time as said Recall materially interferes with the Wholesalers’ ability to fulfill its customers’ orders, provided that such interruption shall not be deemed to occur so long as Distributor holds one week or more of saleable inventory. The Parties shall promptly discuss whether to credit or refund the Purchase Price of any Product subject to the Recall and, if the Parties are unable to agree, then Cipher shall supply to Distributor replacement Product that conforms to the Specifications and Distributor will distribute the replacement Product.

 

(g)           If any Recall is required in circumstances other than provided for in Section 5.3(f) and (h), Distributor will be responsible for the direct costs of such Recall and will reimburse Cipher and its Affiliates within ten (10) Business Days after receipt of an invoice with supporting detail for all of their direct out-of-pocket costs and direct expenses related to such Recall.

 

(h)           If any Recall is required due to Active Ingredient side effects referred to in Section 10.4, the Parties shall be equally responsible for any direct out-of-pocket costs of such Recall that either Party or its Affiliates incur and will reimburse the other Party and its Affiliates within ten (10) Business Days after receipt of an invoice with supporting detail.

 

6.                                      PURCHASE PRICE AND SUPPLY OF PRODUCTS

 

6.1          Supply of Products.

 

(a)           Cipher shall cause its Approved Manufacturer and Contract Finisher to Package the Product for Distributor. Distributor shall purchase from Cipher all of Distributor’s requirements for the Product in the Territory during the Term, pursuant to purchase orders submitted by Distributor or its affiliates to Cipher from time to time in accordance with Section 6.2.

 

(b)           Cipher shall supply all Product under this Agreement to Distributor in the agreed upon dosage strengths, labelled package sizes and minimum batch requirements in accordance with the terms and conditions of this Agreement (including Schedule B and Schedule E). Cipher shall exercise Commercially Reasonable Efforts to deliver Product to Distributor that has a shelf life and expiration date of at least [***] (but in no event less than [***]) at the date of shipment (it being understood that the failure to have [***] shelf life is not a reason for a Rejection Notice pursuant to Section 6.7).

 

(c)           Cipher and its Approved Manufacturer and its Contract Finisher shall be responsible for the purchase of adequate supplies of all materials, including raw materials, in accordance with the NDA and other filings with Regulatory Authorities for the Product as necessary to supply finished Product to Distributor in accordance to the Specifications and applicable Law.

 

(d)           The Product shall be manufactured with Packaging as specified by Distributor acting reasonably, including (i) identifying Cipher’s Approved Manufacturer as the manufacturer of the Products and Distributor as the distributor thereof, (ii) bearing Distributor’s National Drug Code number, and (iii) including appropriate trademark notices. Within five (5) business days after the Effective Date, Distributor shall, at its sole cost and expense, provide Cipher with final specifications for such Packaging for the Products, including all necessary photo-ready artwork (or its substantial equivalent). Distributor,

 

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from time to time but not more than one (1) time per year, may update the Packaging specifications. Such updates shall be subject to the prior written approval of Cipher. Distributor shall, at Distributor’s expense, use Commercially Reasonable Efforts to secure any approvals required by the FDA or any other applicable Regulatory Authority to effect such revisions to the Packaging.

 

(e)           All costs associated with initial packaging setup incurred by the Contract Finisher will be paid by Cipher and, promptly upon Cipher’s invoice with supporting detail, Distributor shall reimburse Cipher for [***] of such costs, provided that such [***] shall in no event exceed [***].

 

(f)            The terms and conditions of this Agreement shall control the Manufacture and supply of Product by Cipher to Distributor, and no terms or conditions contained in any purchase order, acknowledgment, invoice, bill of lading, acceptance or other pre-printed form issued by any Party shall have any force or effect to the extent they are inconsistent with or modify the terms and conditions of this Agreement including those set forth in this Section 6.1, unless mutually agreed in writing by the Parties.

 

(g)           Out-of-pocket costs associated with regulatory changes requested by (i) the Regulatory Authority which cause finished product, raw materials, labelling and other materials to be discarded will be borne [***] by Distributor and [***] by Cipher, and (ii) Distributor which cause product, raw materials, labelling and other materials to be discarded will be borne one hundred percent (100%) by Distributor.

 

(h)           The costs of implementing chemistry, manufacturing and control changes or ancillary additional Testing not included in the original NDA that is either requested by Distributor or a Regulatory Authority after the First Commercial Sale shall be borne one hundred percent (100%) by Distributor if requested by Distributor and [***] by Distributor and [***] by Cipher if requested by a Regulatory Authority.

 

6.2          Forecasts, Orders.

 

(a)           Forecasts; Firm Orders.

 

(i)            The Parties agree to work together to establish mechanisms to ensure timely, efficient, fair, equitable and cost effective supply logistics and materials management. The intent of both Parties is to have finished Product supplied to Distributor for launch purposes as promptly as possible. Distributor shall submit to Cipher prior to the Effective Date a written forecast for twelve (12) months of the quantity of Product including package configuration, including a breakdown by SKU (a “Forecast”). The Forecast shall include the initial Firm Order, which for purposes of determining the Commercialization Milestone shall be deemed to represent Distributor’s launch quantities of the Product. Thereafter, on or before the tenth (10) calendar day of each month during the Term, Distributor shall provide (i) a written, updated twelve (12) month Forecast per packaged dosage strength of the Product including the expected shipping dates for each order during the following twelve (12) consecutive calendar month period beginning on the first day of the following calendar month and (ii) a statement of amount of inventory of the Product held by Distributor and a statement of inventory of the Product held by any Wholesaler as of the approximate end of the previous month. Such Forecasts shall be in multiples of the individual dosage strength batch sizes set out in Schedule B (it being understood Distributor may omit the 150 mg dosage strength from any or all Forecasts) Each such Forecast provided by Distributor shall designate the portion of such Forecast that constitutes Product samples, Each successive Forecast shall update the Forecast previously given. Cipher acknowledges that such Forecasts are only estimates of Distributor’s delivery requirements of the Product (and Product samples) and that Distributor shall not be bound by any such estimate, except that (A) the first [***] within each twelve (12) calendar month Forecast so provided, shall represent a binding commitment of Distributor to require such forecasted quantity of Product (including

 

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Product samples), subject to adjustments for increased quantities within the limits set forth in Section 6.2(b). The portion of the Forecast commencing on the first day of the Forecast period and ending on the last day of the [***] full calendar month after the first day of the Forecast period shall be deemed a firm order period for which Distributor is obligated to order and take ownership of the forecasted Product requirements (each a “Firm Order”) and (B) the first [***] months of each Forecast will repeat the balance of the Firm Order period of the prior Forecast, and the first [***] months of the Forecast shall constitute the new Firm Order period for which Distributor is obligated to purchase and take delivery of the forecasted Product and (C) the [***] month of the Firm Order period may vary one (1) total batch from that set forth in the [***] month of the prior Forecast (the “Prior Forecast”).

 

(ii)           Cipher shall have no liability to Distributor for any failure or inability to supply Distributor with quantities of Product in excess of amounts permitted to he included in Firm Orders as set forth in Section 6.2(a)(i)(C).

 

(iii)          Cipher shall notify Distributor if Cipher determines that it will be unable to meet the quantities of Product in excess of Cipher’s obligations as contemplated in Section 6.2 a ii as soon as practicable but in any event within ten (10) days after receiving the applicable Forecast from Distributor.

 

(iv)          Distributor shall use Commercially Reasonable Efforts to ensure that the Forecasts constitute reasonably accurate predictions (tied to its sales budgets) of the amounts of Product, by Units of’ dosage strength, that Distributor will actually order for the period to which the Forecast relates.

 

(b)           Purchase Orders.

 

(i)            Distributor shall deliver to Cipher its initial purchase order for the Product no later than seventy five (75) days prior to the shipping date required by Distributor. The initial purchase order for the Product shall be for sufficient quantities of the Product to satisfy sales requirements of Distributor for no less than the first three (3) months of sales of that Product. The purchase order shall specify the location to which the Product is to be shipped and the date by which the Product must be shipped to such location.

 

(ii)           During the Term, Distributor shall submit to Cipher, purchase orders for the last month of each Firm Order period no later than one hundred and fifty (150) days (the “Deadline Date”) prior to the required shipping date, identifying the quantities of Product required by dosage strength, type (Authorized Generic or Product) and package size and specifying the required shipping date and ship to location. Such purchase orders shall comply with the Firm Order period provisions set out in Section 6.2(a)(i). If a purchase order for any month is not submitted by the Deadline Date, Distributor shall be deemed to have submitted a purchase order for such month for the amount of Product set forth in Distributor’s most recent Forecast for such month.

 

(iii)          In the event that a purchase order requires an amount higher than the amount set forth in the Forecast for such month (the “Additional Amount”), Cipher shall either (i) confirm to Distributor its acceptance of such purchase order with respect to the Additional Amount within ten (10) calendar days of receipt of such purchase order or (ii) in the event that Cipher cannot supply the Additional Amount indicated in such purchase order, Cipher shall provide Distributor within such ten (10) day period with a delivery schedule for such Additional Amount which Cipher will commit to meet (the “Revised Schedule”).

 

(c)           Batch Sizes. Once the validation batch inventories have been depleted, Forecasts and purchase orders shall be in minimum batch sizes as set forth in Schedule B. Since Cipher may supply

 

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the Product in multiple dosage strengths, the composite of each forecasted dosage strength must equate to the minimum batch sizes and a multiple of the minimum package size as set forth in Schedule B.

 

(d)           Satisfaction by Cipher Affiliates and Approved Manufacturers. Cipher may cause any Affiliate or Approved Manufacturer to satisfy any of the obligations of Cipher under this Article 6. Notwithstanding the previous sentence, Cipher shall remain fully responsible and liable to Distributor for the performance of all terms of this Article 6 by its Affiliates or Approved Manufacturers.

 

(e)           Alternative Delivery of Forecasts and Payments. Cipher may direct Distributor, in writing, to deliver its Forecasts, purchase orders and payments to an Affiliate of Cipher or an Approved Manufacturer, with a copy to Cipher, and to receive shipments of Product from that Affiliate or Approved Manufacturer.

 

(f)            Form of Purchase Orders. All purchase orders placed by Distributor hereunder shall be in a form approved by Cipher, and Distributor shall send such purchase orders by facsimile or by courier to such address(es) as Cipher may direct in writing. Except for terms relating only to quantities, shipping dates and delivery destinations, none of the terms and conditions contained in any purchase order, invoice or similar documents shall have any effect upon or change the provisions of this Agreement unless signed by both Parties and specifically stating that the Parties intend to vary the terms hereof.

 

6.3          Safety Stock. At all times during the Term, Distributor shall use Commercially Reasonable Efforts to maintain not less than [***] days of inventory of Product based upon the Forecasts set forth in Section 6.2(a)(i) (such [***] days of inventory of Product being the “Minimum Safety Stock Level”). If Cipher is unable to meet its obligations to supply Product, Distributor shall draw upon its Minimum Safety Stock Level in an amount equal to Cipher’s failure to supply Product and upon Distributor’s drawing upon its Minimum Safety Stock Level, Distributor’s obligation to maintain the Minimum Safety Stock Level shall be reduced by the amount of Product drawn down until Cipher has replenished the Minimum Safety Stock Level to the agreed amount set forth above. At such time as Cipher is able to resume supply of Product pursuant to the purchase orders, the Parties shall enter into good faith discussions to determine the timetable in which Cipher will replenish the Minimum Safety Stock Level and Distributor shall place purchase orders pursuant to such schedule until Cipher has replenished such Minimum Safety Stock Level.

 

6.4          Method of Delivery of Product. Cipher shall notify Distributor of the location of the Approved Manufacturer or Contract Finisher, if applicable, and of any change thereto. At least fifteen (15) days in advance of the shipping date, Distributor shall advise Cipher in writing of the carrier to be used to ship the Product to Distributor. Any carrier designated by Distributor will require approval by Cipher. Distributor will cause such carrier to comply with all applicable Laws for the shipment of Product. Cipher shall determine the appropriate carrier if Cipher receives no direction from Distributor at least 15 days in advance of the shipping date as to Distributor’s choice of carrier. Distributor shall bear all risk of loss, delay or damage in transit of the Product upon loading of the Product onto the carrier selected by Distributor or Cipher pursuant to this Section 6.4.

 

6.5          Title Transfer. Title to the Product shall pass to Distributor immediately upon loading of the Product onto the carrier selected pursuant to Section 6.4, or fifteen (15) days following notice to Distributor, that the Product is ready for pick-up by the designated carrier.

 

6.6          Continuity of Supply.

 

(a)           Cipher shall use Commercially Reasonable Efforts to satisfy Distributor’s Firm Orders for Product.

 

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(b)           In the event that Cipher is unable to fill any of Distributor’s Firm Orders for the Product, duly issued under Section 6.2 and in compliance therewith, Distributor shall be relieved of any obligation to meet its Minimum Net Sales Requirements set forth in Schedule D during such period as such supply disruption materially interferes with Wholesalers’ ability to fulfill its customers’ orders, provided that such interruption shall not be deemed to occur so long as Distributor holds one week or more of saleable inventory.

 

(c)           For the purposes herein a “Supply Interruption” shall be deemed to have occurred if Distributor has not received ordered Product for at least one-hundred and twenty (120) days past the scheduled and agreed upon delivery date (the “Scheduled Delivery Date”) and Distributor holds no saleable stock of the Product after attempting to maintain at least three (3) months of saleable stock through previous binding orders (subject to Cipher’s delivery thereof) (a “Stock-out”), unless such Supply Interruption is caused by (A) a delay due to shortage in supply of useable Active Ingredient or any other manufacturing material supplied by a Third Party through no fault of Cipher, (B) a material breach of this Agreement by Distributor for which Cipher has provided written notice thereof to Distributor, or (C) a Force Majeure. Notwithstanding anything contained here, if a Supply Interruption lasts for more than six (6) months, Distributor, at its discretion, shall have the option to either: (I) terminate this Agreement upon thirty (30) days’ notice to Cipher, or (II) on written notice to Cipher, require Cipher to seek, on Distributor’s behalf, from Galephar: (i) a non-exclusive, royalty-free Manufacturing license and, if applicable, Packaging license for the Product, including a license under applicable Product Patents (ii) access to all Product Technology to enable Distributor to Manufacture the Product and (iii) the right to observe Cipher’s or the Approved Manufacturer’s Manufacture of the Product, subject to reasonable confidentiality undertakings on behalf of such observers, and to receive reasonable cooperation by Cipher, its Approved Manufacturer and their Affiliates prior to and following the effectiveness of the license and transfer contemplated hereby. Notwithstanding subpart ()I) above, Cipher shall have no obligation to seek such a license from Galephar on behalf of Distributor if Cipher has obtained or is seeking to obtain from Galephar its own Manufacturing license and, if applicable, Packaging license for the Product. If granted to Distributor, Distributor acknowledges that the foregoing license shall be limited to the use of such Product Technology only for the Manufacture of the Product for Marketing in the Territory pursuant to this Agreement and for no other purpose. If Galephar grants such license, Distributor shall be responsible for all costs associated with obtaining any necessary Approvals to Manufacture the Product. In addition, Distributor shall undertake all normal responsibilities for ensuring (1) the purity, identity, potency, and quality of the Product, (2) its appropriate packaging and labelling, (3) its compliance with all applicable Laws, including the Act and GMP, (4) that its labelling is applied only to packaging containing the Product, (5) there is no significant chemical, physical, or other change or deterioration in the Product, and (6) that each batch of the Product meets the Specifications thereof in the NDA. Notwithstanding the granting of the foregoing license, Cipher and its Approved Manufacturer(s) shall retain the right at all times to supply Distributor with at least [***] of its Product requirements. Distributor agrees that it will not seek directly or indirectly from Galephar a license to Manufacture except pursuant to this Section 6.6(c) and only if Cipher does not seek a license as contemplated above or is refused a license. In the event Cipher is unable to obtain such a license from Galephar within thirty (30) days of receipt of Distributor’s written notice in subpart (II) above, Distributor shall have the right terminate this Agreement upon written notice to Cipher immediately upon the expiration of such thirty (30) day period.

 

6.7          Acceptance, Rejection and Revocation of Acceptance.

 

(a)           Cipher shall provide a certificate of analysis and other documents as defined in the Technical Agreement, in such forms as the Parties shall agree upon, for any Product batch delivered to Distributor hereunder certifying that such Products have been Manufactured and Packaged in compliance with the Specifications, GMPs and all other applicable Regulatory Requirements and with an expiry date

 

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of not less than [***] months from the date of shipment. Such certificate of analysis shall be included with each shipment of Product to Distributor.

 

(b)           Distributor shall inspect or shall cause to be inspected all shipments of Product promptly upon receipt. Distributor may reject any Product which does not conform to the Specifications or the expiry requirements at the time of receipt at Distributor’s location. Distributor shall make any such rejection in writing, promptly to Cipher, and shall indicate the reasons for such rejection (the “Rejection Notice”).

 

(c)           If Distributor has not delivered a Rejection Notice within thirty (30) days after receipt of the shipment of Product at the facility designated by Distributor in the purchase order, Distributor shall be deemed to have accepted that shipment of Product. Once Distributor has accepted or has been deemed to have accepted a shipment of Product, Distributor shall have no claim or recourse against Cipher relating to such Product under this Section 6.7 with respect to any non-conformance to the Specifications which should have been detected by Distributor through an examination of the Product in accordance with the GMP obligations of a Distributor of the Product, and Distributor may not exercise any rights to subsequently reject such shipment under this Section 6.7; provided, however, that in the event the non-conformance with the Specifications is of a nature that would prevent it from being detected by Distributor through examination as described above, Distributor may reject such Product promptly upon discovery of such non-conformity, notwithstanding Distributor’s prior acceptance of the shipment or the expiration of such thirty (30) day period, provided that the Rejection Notice shall not be delivered later than two (2) Business Days following such discovery.

 

6.8          Rejection Procedures.

 

(a)           After Cipher receives the Rejection Notice, it will evaluate process issues and the reasons given by Distributor for the Rejection. Cipher shall use good faith efforts to promptly notify Distributor whether it agrees with the basis for Distributor’s rejection, but in no event shall such notice be given later than thirty (30) days of Cipher’s receipt of a Rejection Notice, provided that if Cipher wishes to Test the Product, notice shall be given not later than ninety (90) days of Cipher’s receipt of a Rejection Notice. If Cipher does not so notify Distributor within thirty (30) or ninety (90) days, as applicable, of receipt of the Rejection Notice as to whether it agrees with the basis of Distributor’s rejection, Cipher shall be deemed to be in agreement therewith.

 

(b)           If Cipher agrees with or is deemed to agree with the basis for Distributor’s rejection, Cipher shall promptly replace, at no cost to Distributor, such rejected Product.

 

(c)           If Cipher disagrees with the basis for Distributor’s rejection specified in the Rejection Notice, Cipher shall promptly replace such rejected Product. No payment shall be due with respect to the replacement Product until it is determined which Party shall bear the burden of such cost hereunder. The Parties shall submit samples of the rejected Product to a mutually acceptable Third Party laboratory, which shall determine whether such Product meets the Specifications and, as part of this process, may also carry out a full investigation of the Manufacturing process including, as necessary, the Approved Manufacturing Site) for such Product if it reasonably believes such an investigation is necessary to resolve the disagreement. The Parties agree that the determination of the Third Party laboratory, after it has assessed the retention samples and following any full investigation of the Manufacturing process it conducts, shall be final and determinative. If the Third Party laboratory determines that the retained samples meet the Specifications, the rejection by Distributor is deemed to be unjustified, and Distributor shall reimburse Cipher for any Product-related costs or testing undertaken by Ciphcr internally and shall promptly pay Cipher for any replacement Product. If the Third Party laboratory determines that the relevant shipment of Product does not meet the Specifications, Cipher shall not invoice Distributor for the replacement Product.

 

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The Party against whom the Third Party laboratory rules shall also bear the fees charged by the Third Party laboratory in connection with resolution of the disagreement, including all costs of investigating the Manufacturing process.

 

(d)           At Cipher’s election and upon authorization from Cipher, Distributor shall destroy the rejected Product promptly and provide Cipher with certification of such destruction unless Cipher elects to have the Product returned, in which event Distributor shall cooperate in arranging such return. If Cipher agrees with the basis for Distributor’s rejection or if the Third Party laboratory rules against Cipher, Cipher shall pay the cost of destroying or returning the Product. In all other cases, Distributor shall bear such costs.

 

(e)           Notwithstanding any of the other provisions in this Agreement, Distributor agrees that the remedies set forth in this Section 6.8 are Distributor’s sole and exclusive remedies with respect to claims relating to Product that Distributor has rejected.

 

6.9          Prices and Payments.

 

(a)           Distributor shall pay to Cipher the following:

 

(i)            The Up-Front Payment in the amount and at the time as set out in Part A of Schedule C;

 

(ii)           The Sales Milestone Payments in the amounts and at the time as set out in Part B of Schedule C;

 

(iii)          The Purchase Price for Product supplied by Cipher in the amounts calculated in accordance with the provisions of Part C of Schedule C;

 

(iv)          The Royalty Payments in the amounts and at the time as set out in Part D of Schedule C;

 

(b)           Distributor shall make all payments contemplated by this Agreement in the lawful currency of the United States of America and Distributor shall make such payments to such address as Cipher may from time to time direct in writing to Distributor.

 

(c)           Cipher shall pay all insurance and shipping costs and any Taxes imposed on shipment of Product from the Approved Manufacturer to the Contract Finisher. Distributor shall pay all insurance and shipping costs and any Taxes imposed on shipment of Product from the Contract Finisher to the location specified by Distributor.

 

(d)           Distributor shall be responsible for the payment of any duties, levies or Taxes applied to the sale of the Product in the Territory by any relevant Tax authority.

 

(e)           At such time as a Generic Equivalent is available for sale in the Territory by a Third Party, Cipher hereby authorizes Distributor, at Distributor’s option, to Market a Generic Equivalent supplied by Cipher (an “Authorized Generic”) in the Territory under Distributor’s trademarks subject to the following conditions: (i) Cipher shall manufacture and supply to Distributor, its Affiliates and any of its sublicenses, all of Distributor’s requirements of the Authorized Generic, in finished Product form; (ii) Distributor shall pay Cipher, within thirty (30) days following the end of each calendar quarter, the then current finished Product capsule price, as applicable, as set forth in Schedule F hereto; and (iii) a royalty based on Net Sales of the Authorized Generic at a rate equal to the same royalty rate set out in Part D of Schedule C provided in the event that a second Generic Equivalent (other than the Authorized Generic) is

 

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launched in the Territory, then the royalty payment is modified such that the same royalty rate is applied to the Authorized Generic’s Net Profit and the Net-to-Gross Floor shall not apply (“AG Royalty Payments”).

 

6.10        Audit. Distributor shall keep and retain complete and accurate records pertaining to the disposition of Product and amounts payable under this Agreement for each Fiscal Year or part thereof during the Term in sufficient detail to permit Cipher to confirm the accuracy of all payments made or due hereunder for a period of seven (7) years following the applicable Fiscal Year or part thereof. Cipher shall have the right to appoint an independent internationally recognized audit firm to audit the books of account of Distributor in order to determine whether Distributor has properly reported and accounted for any fees or payments due to Cipher pursuant to this Agreement. The appointed audit firm may perform audits during regular business hours, not more than once in any calendar year during the Term and upon reasonable prior notice to Distributor. Cipher shall bear the audit fees unless such Third Party auditor determines that the amount actually due Cipher, in the aggregate, exceeds the amounts paid or deemed paid by Distributor hereunder by [***] or more, in which case Distributor shall bear the audit fees. Distributor shall forthwith pay any amounts discovered to be due pursuant to an audit together with interest (calculated according to Section 9.3) from the date such amounts were originally due and owing to Cipher. The results of the audit shall be final and binding upon the Parties.

 

6.11        Facility Audits.

 

(a)           Distributor and/or its nominee shall have the right to conduct an audit of any Approved Manufacturing Site(s) at which the Product is being Manufactured, of Manufacturing records (including batch records) relating to the production of such Product, if applicable, of the Contract Finisher(s)’ facility where Product is Packaged and of any correspondence between Cipher and the Regulatory Authority related to such Product or such facilities, in each case during business hours upon ten (10) Business Days prior written notice to Cipher but not more than once per calendar year during the Term of this Agreement, unless either Party, any Authority or any Third Party raises any questions about the quality of the Product which could have a material detrimental effect on the sales or use of the Product, in which case Distributor’s audit right shall not be subject to the foregoing annual limitation until the specific issue in question has been resolved, and Cipher shall promptly supply or cause its Approved Manufacturer to supply to Distributor all data and results relating to all Testing performed in connection with the issue in question.

 

(b)           Cipher and/or its nominee shall have the right to conduct an audit of the facilities and records of Distributor, and/or its SubDistributors relating to the Marketing, Testing, and storage of the Product and of any correspondence between Distributor, its SubDistributors and the Regulatory Authority related to the Product or such facilities, during business hours upon ten (10) Business Days prior written notice to Distributor not more than once per calendar year during the Term of this Agreement, unless any Authority or any Third Party raises any questions about the quality of the Product or the Testing, Marketing or storage thereof which could have a material detrimental effect on the sales or use of the Product, in which case Cipher’s audit right shall not be subject to the foregoing annual limitation until the specific issue or question has been resolved, and Distributor shall promptly supply to Cipher all data and results relating to all Testing performed by Distributor on the Product.

 

7.                                      INTELLECTUAL PROPERTY

 

7.1          Ownership of Cipher Intellectual Property. Cipher shall retain all of its rights, title and interest in and to all Product Technology, Cipher Trademarks, copyrights, and all other industrial and Intellectual Property embodied in or which covers the Product, in each case which is owned, held, or licensed by it as of the Effective Date or thereafter or developed, created or discovered by it or on its behalf during the Term. Except as otherwise expressly provided in this Agreement, Distributor has and shall have

 

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no right, title or interest in any Intellectual Property owned by or licensed to Cipher relating to the Product including the Product Technology and Cipher Trademarks or other Distributor Intellectual Property.

 

7.2          Ownership of Distributor Intellectual Property. Subject to the last sentence of Section 7.1, Distributor shall retain all of its right, title and interest in and to all copyrights and all other Intellectual Property owned, held, or licensed by it as of the Effective Date or thereafter developed, created or discovered by it or on its behalf during the Term, including the Trademarks. For clarification purposes, the Parties agree that nothing herein grants, or constitutes an agreement or obligation to grant, to Cipher, any Approved Manufacturer or any of their Affiliates or other Third Party any right, title or interest in, to or under any of the Trademarks.

 

7.3          Maintenance and Prosecution of Product Patents. The Parties acknowledge Distributor has been advised that, as between Cipher and Galephar: (i) Cipher is a licensee of Galephar and (ii) Galephar shall remain responsible for maintenance of Product Patents and shall bear all expenses associated therewith including prosecution, renewal and other fees necessary to obtain and maintain the Product Patents in full force and effect until the earlier of their expiration or the termination or expiration of this Agreement.

 

7.4          Notice of Patent Infringement.

 

(a)           Information Concerning Infringement. If either Party shall learn of (i) any claim or assertion that the Manufacture, Marketing, Testing or Packaging of the Product, or the use of the Product Technology or other Intellectual Property related to the Product infringes, misappropriates or otherwise violates the Intellectual Property rights of any Third Party, or (ii) the actual or threatened infringement, misappropriation or other violation by any Third Party of the Product Technology or other Intellectual Property related to the Product, then the Party becoming so informed shall as soon as reasonably practicable, but in all events within fifteen (15) Business Days thereof, notify the other Party of such claim or assertion, or actual or threatened infringement, misappropriation or other violation.

 

(b)           Potential Infringement. In the event either Cipher or Distributor learns of any Third Party patents which may cover the Manufacturing, Marketing or, if applicable, Testing or Packaging of the Product in the Territory, as carried out by Distributor in accordance with its rights under this Agreement, such Party will notify the other Party. The Parties agree to confer in good faith regarding such potential infringement risk and to explore reasonable alternatives for avoiding such risk and to provide such information to each other as either Party may reasonably request.

 

(c)           Third Party Claims; Defense by Cipher. If a Third Party files or threatens to file a claim, suit or action against Distributor claiming that a patent or other Intellectual Property right held by it is infringed, misappropriated or otherwise violated by the Manufacturing, Marketing or, if applicable, Testing or Packaging of the Product, and such claim, suit or action arises out of Distributor’s exercise of its rights under this Agreement, the Parties shall confer in good faith regarding such alleged infringement, misappropriation or other violation. Cipher may, but shall not be obligated to, defend any such claims, suits or actions. If Cipher elects to defend such claims, suits or actions, it shall notify Distributor that it has elected to do so. Cipher shall provide information to Distributor of the conduct of the defence of such claims, suits or actions as Distributor may reasonably request from time to time. Distributor will assist in the defence of any such claim, suit or action as reasonably requested by Cipher. The Parties shall bear [***] the cost of any payments made to Third Parties as a result of any actual or alleged infringement and all reasonable legal fees incurred by the Parties. Cipher shall not settle any such claim, suit or action if such settlement would impose on Distributor the obligation to pay any claim, without the prior express written consent of Distributor,

 

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(d)           Defense by Distributor. If Cipher elects not to defend against Third Party claims, suits or actions pursuant to Section 7.4(c), Cipher shall give notice of its decision to Distributor within reasonably sufficient time to permit Distributor to defend against such claims, suits or actions. If Distributor elects to defend such Third Party claims, suits or actions, it shall notify Cipher that it has elected to do so and shall notify Cipher in writing of its proposed legal counsel. Distributor’s choice of counsel shall be subject to Cipher’s approval, which approval shall not he unreasonably withheld. Distributor shall provide information to Cipher of the conduct of the defence of such claims, suits or actions as Cipher may reasonably request from time to time and Cipher shall assist in such defence as reasonably requested by Distributor. The Parties shall bear [***] the cost of any payments made to Third Parties as a result of any actual or alleged infringement and all reasonable legal fees incurred by the Parties. Distributor shall not settle any such claim, suit or action without the prior express written consent of Cipher.

 

(e)           Injunction. In the event Distributor is enjoined from Marketing the Product by a Third Party alleging infringement, misappropriation or other violation of its patent or other Intellectual Property right, Distributor’s obligations to pay the Minimum Net Sales Requirement and to Market the Product pursuant to Section 3.1 shall be held in abeyance until such time as said injunction is lifted and sales return to the levels in effect prior to the institution of the injunction at which point any obligations to pay the Minimum Net Sales Requirements and to Market the Product pursuant to Section 3.1 shall resume.(it being understood that the end date for the Minimum Net Sales Requirement and Marketing obligations pursuant to Section 3.1 shall be deemed extended for the amount of such eliminated period).

 

7.5          Cipher Trademarks Indemnified Infringement Claims. Cipher agrees that it shall, at its own cost and expense, defend, indemnify and hold harmless the Distributor Indemnitees from and against any and all liabilities, losses, damages, actions, claims and expenses suffered or incurred by the Distributor Indemnitees (including reasonable attorneys’ fees, court costs and expert witnesses’ fees) arising out of, resulting from or otherwise related to the Cipher Trademarks used by any Distributor Indemnitee as permitted by this Agreement (such claims the “Cipher Indemnified Infringement Claims”), provided that any such Cipher Indemnified Infringement Claim does not arise from Distributor’s breach of this Agreement, or arise from Distributor’s negligent or intentionally wrongful conduct. Cipher shall not indemnify any Distributor Indemnitees for any infringement action, other than the Cipher Indemnified Infringement Claims, that is initiated or otherwise brought by a Third Party (provided, however, that for purposes of clarification, the Parties agree that nothing in this Section 7.5 limits Cipher’s obligations to bear an equal share of any payments made to Third Parties as provided under Section 7.4(c) or Section 7.4(c) or indemnity obligations under Article 10 of this Agreement).

 

7.6          Distributor Trademarks Indemnified Infringement Claims. Distributor shall, at its own cost and expense, defend, indemnify and hold harmless the Cipher Indemnitees from and against any and all liabilities, losses, damages, actions, claims and expenses suffered or incurred by Cipher Indemnitees (including reasonable attorneys’ fees, court costs and expert witnesses’ fees) arising out of, resulting from or otherwise related to the Trademarks used by Distributor, its Affiliates, sublicenses, SubDistributors or agents as permitted by this Agreement (such claims the “Distributor Indemnified Infringement Claims”), provided that any such Distribution Indemnified Infringement Claim does not arise from Cipher’s breach of this Agreement, or arise from Cipher’s negligent or intentionally wrongful conduct (it being expressly understood that Cipher’s reasonable exercise of its rights hereunder with respect to this Agreement shall not he considered to be negligent or intentional wrongful conduct). Distributor shall not indemnify any Cipher Indemnitees for any infringement action, other than the Distributor Indemnified Infringement Claims, that is initiated or otherwise brought by a Third Party (provided, however, that for purposes of clarification, the Parties agree that nothing in this Section 7.6 limits Distributor’s obligations to bear an equal share of any payments made to Third Parties as provided under Sections 7.4(c) or Section 7.4(c) or indemnity obligations under Article 10 of this Agreement).

 

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7.7          Infringement of Product Technology by a Third Party.

 

(a)           Action by Cipher. Cipher may, but shall not be obligated to, commence, at its own expense, an infringement action against any Person infringing or allegedly infringing the Product Technology, including actions for direct or contributory infringement or misappropriation of Product Technology. Distributor shall cooperate with Cipher as reasonably requested, at Cipher’s expense. If Distributor so desires, it may join such action at its own expense, and Cipher shall not oppose any attempt by Distributor to join, or otherwise intervene in such action. Any and all amounts recovered with respect to such an action shall be applied first to reimburse the Parties for their out-of-pocket expenses (including reasonable attorney’s fees) in prosecuting such infringement or misappropriation. The remainder shall be [***] by Distributor and Cipher.

 

(b)           Action by Distributor. In the event that Cipher becomes aware of any Person infringing or potentially infringing the Product Technology, whether by direct or indirect infringement, or by misappropriation of Product Technology, it shall promptly decide whether to commence litigation against such Person. Cipher shall make such decision within fifteen (15) days of receipt or notification of a patent non-infringement or invalidity certification made under section 505(j) of the U.S. Food Drug and Cosmetic Act. In the event Cipher does not or elects not to commence an action against the Person responsible for the alleged or threatened infringement or misappropriation in the time frame specified in this Section 7.7(b), then Distributor may, but shall not be required to, prosecute the alleged infringement or threatened infringement. Distributor shall respond to any notice given to it within ten (10) days thereafter as to whether it will prosecute an alleged or threatened infringement or misappropriation, in order that Galephar has an opportunity to pursue such action if Distributor chooses not to do so. If Distributor wishes to prosecute an action, it shall act in its own name and at its own expense, unless in Distributor’s legal judgment it is necessary or advisable to join Cipher or Galephar to satisfy joinder or real party in interest rules governing litigation in Federal Courts or provisions of the Hatch Waxman Act. At Distributor’s expense, (i) Cipher shall cooperate and join with Distributor as necessary and reasonably requested, and (ii) Cipher shall require the cooperation and joinder of Galephar as necessary and reasonably requested. If Cipher so desires, it may join such action at a later date, at its own expense, and Distributor shall not oppose any attempt by Cipher to join or to have Galephar join, or otherwise intervene, in such an action. Any amounts recovered with respect to such an action shall be applied first to reimburse the Parties for their out-of-pocket expenses (including reasonable attorneys’ fees) in the prosecution of such infringement. The remainder shall be [***] by Distributor and Cipher.

 

(c)           Action by Galephar. In the event that neither Cipher nor Distributor elects to commence any action, pursuant to Section 7.7(a) or (b) above, Galephar may, but shall not be required to, prosecute the alleged infringement or threatened infringement at Galephar’s expense. At Cipher’s request, Distributor shall cooperate and join with Galephar as necessary and reasonably requested. Distributor shall not be entitled to any amounts recovered.

 

7.8          Trademarks.

 

(a)           License. Subject to the terms and conditions of this Agreement, Cipher hereby grants to Distributor an exclusive right within the Territory to use the Cipher Trademarks solely for the purposes of Marketing the Product under this Agreement. Such license shall not preclude Cipher and/or any Approved Manufacturer from using Cipher Trademarks within the Territory for: (i) other products other than the Product; or (ii) any Product that is to be Marketed or sold outside the Territory.

 

(b)           No Obligation to Use Trademarks. Distributor may use the Cipher Trademarks only as indicated on Schedule A and as designated by Cipher. Distributor may use its own Trademarks on Product Packaging, brochures and other promotional materials to identify itself as the distributor of the

 

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Product provided that Distributor has obtained the applicable Regulatory Approval. Notwithstanding any provision to the contrary, the Cipher trade name for which application has been made cannot be replaced without the prior written approval of Cipher.

 

(c)           Cipher Ownership. Distributor hereby agrees to and recognizes Cipher’s exclusive ownership or license rights of the Cipher Trademarks and the renown of the Cipher Trademarks. Distributor agrees not to take any action inconsistent with such ownership and further agrees to take any action, at Cipher’s expense, which Cipher reasonably deems necessary to establish and preserve Cipher’s exclusive rights in and to the Cipher Trademarks, including cooperating in the registration of the Cipher Trademarks on the trademark registry or other appropriate registration procedure in each jurisdiction in the Territory.

 

(d)           Distributor Ownership. Cipher hereby agrees to and recognizes Distributor’s exclusive ownership or license rights of the Trademarks and the renown of the Trademarks. Cipher agrees not to take any action inconsistent with such ownership and further agrees to take any action, at Distributor’s expense, which Distributor reasonably deems necessary to establish and preserve Distributor’s exclusive rights in and to the Trademarks including cooperating in the registration of the Trademarks on the trademark registry or other appropriate registration procedure in each jurisdiction in the Territory.

 

(e)           Cipher Goodwill. The Parties agree that all use of the Cipher Trademarks by Distributor shall be for the sole and exclusive benefit of Cipher and the goodwill and reputation accrued in connection with Distributor’s or its Affiliates’ or SubDistributors’ use of the Cipher Trademarks shall accrue solely to Cipher. In the event Distributor acquires any right, title or interest in or to or relating to the Cipher Trademarks for any reason, Distributor shall immediately assign or cause to be assigned ( in the case of Distributor’s Affiliates) at no cost to Cipher, all such right, title and interest, together with any related goodwill or reputation, to Cipher. Distributor agrees to promptly execute all documents reasonably requested by Cipher in connection with such assignment.

 

(f)            Distributor Goodwill. The Parties agree that all use of the Trademarks by Distributor and its Affiliates and SubDistributors shall be for the sole and exclusive benefit of Distributor, and the goodwill and reputation accrued in connection with Distributor’s or any Affiliate’s or SubDistributor’s use of the Trademarks shall accrue solely to Distributor. The Parties agree that Cipher and its Affiliates will have no rights to use (or to authorize the use by any Third Party) any of the Trademarks. Notwithstanding the foregoing, in the event Cipher, or any of its Affiliates acquires any right, title or interest in or to or relating to the Trademarks for any reason, Cipher shall immediately assign, or cause to be assigned (in the case of Cipher’s Affiliates), at no cost to Distributor, all such right, title and interest, together with any related goodwill or reputation, to Distributor. Cipher or its Affiliates shall promptly execute all documents reasonably requested by Distributor in connection with such assignment.

 

(g)           Infringement. Distributor agrees that only Cipher has the right to enjoin any infringement or registration by a Third Party of the Cipher Trademarks, provided, however, that Cipher may authorize Distributor to enjoin such infringement or registration. Distributor will assist in the prosecution of any such action as reasonably requested by Cipher at Cipher’s cost.

 

(h)           No Confusion. Distributor shall not adopt, use, or register any acronym, trademark, trade names, service mark or other marketing name that is confusingly similar to the Cipher Trademarks or the Cipher name, and shall not use the Cipher Trademarks or the Cipher name other than in connection with the Marketing of the Product pursuant to this Agreement. Cipher shall not adopt, use, or register any acronym, trademark, trade names, service mark or other marketing name that is confusingly similar to the Trademarks or Distributor name, and shall not use the Trademarks or Distributor name other than in connection with the Manufacturing and Testing of the Product pursuant to this Agreement or as otherwise set forth in this Agreement.

 

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7.9          Galephar’s Acknowledgement; Distributor’s Ability to Cure. Prior to or simultaneously with the execution of this Agreement, Galephar and Cipher shall execute an acknowledgement of this Agreement, acceptable to Distributor. In addition, should Galephar threaten to terminate or revoke any supply or license agreement due to Cipher’s failure to pass through payments for Product by Distributor, or otherwise make payments to Galephar, then Distributor shall have the right to pay Galephar directly for COGS and other payments which Cipher acknowledges and agrees are due to Galephar, and to reduce any monies owed Cipher by the amount paid to Galephar.

 

8.                                      CONFIDENTIALITY

 

8.1          Cipher’s Information. Except as provided in Section 8.3 or elsewhere in this Agreement, Distributor shall maintain all Confidential Information provided by Cipher to Distributor, whether in writing, electronically, orally or through access to Cipher’s premises, in strict confidence. Such information shall remain the property of Cipher, and Distributor shall not use the same for or on behalf of any Person or entity other than Cipher or make use of any such information except as permitted by this Agreement without the express prior written approval of Cipher.

 

8.2          Distributor’s Information. Except as provided in Section 8.3 or elsewhere in this Agreement, Cipher shall maintain all Confidential Information provided by Distributor to Cipher, whether in writing, electronically, orally or through access to Distributor’s premises, in strict confidence. Such information shall remain the property of Distributor, and Cipher shall not make use of any such information except as permitted by this Agreement without the express prior written approval of Distributor.

 

8.3          Exceptions. The covenants of the receiving Party contained in Section 8.1 and Section 8.2 shall not apply to Confidential Information that the receiving Party can reasonably demonstrate by competent proof is: (a) required to be disclosed by Law or a court or other Authority pursuant to (i) regulatory filings; (ii) prosecuting or defending litigation; (iii) complying with applicable Law and orders or decisions of any Official Body having jurisdiction; (iv) necessary to the limited extent only to conducting pre-clinical or clinical trials of Product and persons involved in such trials are bound by similar terms of confidentiality; or (b) disclosed to Affiliates who agree to be bound by similar terms of confidentiality. Notwithstanding any provision herein to the contrary, nothing herein shall prevent or prohibit any disclosure of any information concerning this Agreement (A) required under applicable securities Laws and the rules and regulations of any stock exchange or market system on which any Party’s securities are or may be traded, (B) by either Party in connection with an Approved Transaction (as defined below), where prospective parties or the other party or parties to such Approved Transaction have entered into confidentiality agreements with the Party concerning such Confidential Information, (C) to either Party’s financial advisors or legal advisors who have agreed to the limitations on disclosure contained herein and/or (D) to investment bankers and/or financing sources in connection with bona fide financing transactions involving either Party or an Affiliate who have agreed to the limitations on disclosure contained herein. For the purposes of this Agreement, each of the following shall constitute an “Approved Transaction”: (i) the issuance by either Party of securities in connection with any financing transaction or public offering, and/or (ii) a merger, consolidation or other similar transaction involving either Party (i.e., wherein another entity acquires all or substantially all of that Party’s equity interests or assets). If a Party is required or permitted to make a disclosure of the other Party’s Confidential Information pursuant to this Section 8.3, it will use Commercially Reasonable Efforts to (I) limit the scope of the Confidential Information disclosed and the number of persons to whom such Confidential Information is disclosed, in each case to the minimum extent required to address the reason such disclosure is permitted hereunder and (II) secure confidential treatment of such Confidential Information and comply with any applicable provisions of Section 12.6.

 

8.4          Publications. A Party primarily responsible for a proposed publication (excluding any publication required under applicable securities Laws, which shall be subject to the provisions of Sections

 

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8.3 and Section 12.6) relating to the Product in the Territory (the primary purpose of which is not advertising or promotion), whether written or oral, shall, at least thirty (30) days before presentation or submission of the proposed publication to a Third Party, submit such proposed publication to the other Party for review in connection with obtaining or preserving Intellectual Property rights and/or to determine whether such other Party’s Confidential Information is contained therein and should be modified or deleted. The receiving Party shall have thirty (30) days in which to review and consent to each proposed publication. The Parties may mutually agree to extend the review period for an additional thirty (30) days when the receiving Party provides a reasonable need for such extension, including, but not limited to, the preparation and filing of pertinent patent applications.

 

9.                                      TERM AND TERMINATION OF AGREEMENT

 

9.1          Term. The term of this Agreement shall commence on the Effective Date and continue for ten (10) years from the date of the Commercialization Milestone is achieved, unless earlier terminated pursuant to Section 9.2 (the “Initial Term”). Distributor shall have the right to renew the Agreement for two (2) additional five (5) year periods (each a “Renewal Term” and together with the Initial Term, the “Term”) by providing at least six (6) months written notice to Cipher prior to the expiry of the then current Term.

 

9.2          Termination.

 

(a)           Material Breach. A Party shall have the right to terminate this Agreement upon prior written notice to the other Party for material breach of this Agreement by the other Party (which includes any failure by Distributor to pay amounts when due to Cipher in accordance with the terms of this Agreement or failure to meet the performance obligations set forth in Section 3.1). Any notice of material breach shall specify the breach in reasonable detail. Unless otherwise provided in this Agreement (including, without limitation, Sections 5.3, 6.6 and 6.8 hereof), the termination shall be effective thirty (30) days after receipt of the written notice, unless the breaching Party cures the breach within that thirty (30) day notice period, or, if such breach is incapable of cure within such thirty (30) day period, the breaching Party has commenced good faith efforts to cure such breach within such thirty (30) day period and cures such breach within three (3) months after the receipt of the notice of material breach. Notwithstanding the foregoing, the cure period regarding any breach associated with the quarterly marketing obligations outlined in Section 3.1 will expire at the end of the following quarter, provided that the marketing obligations for such following quarter are also satisfied in such quarter.

 

(b)           Bankruptcy and Insolvency. A Party shall also have the right to terminate this Agreement in the event that a court of competent jurisdiction declares the other Party insolvent or bankrupt, or a bankruptcy proceeding is commenced against the other Party or the other Party files a proposal, assignment for the benefit of creditors, arrangement, composition or seeks similar relief under any applicable bankruptcy law or the other Party is in receivership, in which case termination shall be effective upon written notice to that effect.

 

(c)           Assignment to Competitor. Cipher may terminate this Agreement as contemplated by the last sentence of Section 12.5 hereof.

 

9.3          Interest Payments. Any payments to be made to Cipher pursuant to this Agreement and which have not been made within the timeframes set forth in this Agreement shall accrue interest from the date payment was originally due at a floating annual rate of [***] above the commercial prime rate of interest as published in The Wall Street Journal, or similar publication if The Wall Street Journal is no longer published. Additionally, Distributor shall be responsible for all reasonable attorneys’ fees, witness

 

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fees and court costs and other costs incurred by Cipher to recover amounts owing to it hereunder following termination of this Agreement.

 

9.4          Accrued Rights, Surviving Obligations. Termination or expiration of this Agreement shall not affect any accrued rights of either Party. Distributor’s obligations under Sections 3.6, 4.5, 5.1, 5.2, 5.3, 6.9, 6.11(b) and both Party’s obligations under Sections 6.10, 7.1, 7.2, 7.5, 7.6, 7.8(e), 7.8(f), 9.3, 9.4, 9.5, 9.6 and 9.7, and Articles 8, 10, 11 (solely with respect to the representations, warranties and related provisions contained therein, which shall survive to the extent necessary to give effect to the rights and remedies (and limitations thereof)), and Article 12 of this Agreement shall survive termination or expiration of this Agreement.

 

9.5          Transitional Matters.

 

(a)           Upon expiration or termination (other than pursuant to Section 9.2(a) for a material breach by Distributor) of the Agreement, Distributor may, where permitted by Law, sell the Product then in its inventory for a period of [***] thereafter (the “Sell-Off Period”), all in accordance with the terms of this Agreement. Notwithstanding the foregoing, Cipher shall, at its sole option, have the right to either provide distribution exclusivity during the Sell-Off Period or repurchase during the Sell-Off Period unsold product in inventory, with a shelf-life of at least [***], at the Purchase Price paid by Distributor for such unsold Product. Promptly after the expiration of the Sell-Off Period, Distributor will, at its cost, destroy any unsold Product remaining in its inventory and will provide appropriate evidence of such destruction to Cipher or, at Cipher’s request, will return such inventory to Cipher at Cipher’s cost. Cipher will have the right to cancel any purchase orders placed by Distributor which were accepted by Cipher prior to such termination or expiration, and which require delivery of Product after the date of termination or expiration including during the Sell-Off Period.

 

(b)           Upon termination of this Agreement, Distributor and Cipher shall at their own expense use best efforts to ensure that the continuity of patient care is not disrupted including transferring of managed care contracts, adverse event reporting, and dealing with supply chain matters. In addition, Distributor will remain responsible for returned Product sold prior to termination of this Agreement and Cipher will be responsible for returned Product sold following termination of this Agreement. For the purpose of identifying the responsible party, Product will he tracked via lot numbers.

 

9.6          Transfer of Approvals. Upon expiration or termination of the Agreement, Distributor shall to the extent permitted by applicable Law, promptly transfer or cause to be transferred to Cipher all Approvals relating to the Product that are in the name of Distributor, at Distributor’s cost (except in the case of any termination by Distributor under Sections 9.2(a) or 9.2(b), in which case Cipher shall bear such costs).

 

9.7          Effect of Termination. Termination of this Agreement shall not operate to release either Party from any obligation or liability incurred under this Agreement prior to or upon termination hereof or which, by the terms hereof, survives termination. Upon any termination of this Agreement, except to the extent required for the purposes of Section 9.5, (i) all licenses and rights granted to Distributor hereunder shall immediately terminate, (ii) all rights, properties and interests granted by Cipher to Distributor shall immediately revert to and become fully vested in Cipher and Distributor shall return to Cipher all copies of documents regarding the Product and all Confidential Information supplied by Cipher, and (iii) Distributor shall promptly assign all existing contracts, agreements, and approvals with Other Authorities to Cipher. For the avoidance of doubt, the Parties acknowledge that Cipher shall have no rights to the Trademarks following any termination of this Agreement.

 

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9.8          Notice of Non-Renewal. If Distributor does not exercise its renewal rights pursuant to Section 9.1 or upon the delivery by Cipher of any notice of termination of this Agreement or delivery by Distributor of any notice of termination of this Agreement that is accepted by Cipher, Cipher may, prior to the termination of this Agreement, enter into negotiations with any other Person to Market the Product in the Territory following termination and no notice is required to Market the Product in the Territory after the effective date of the termination.

 

10.                               INDEMNITY

 

10.1        Indemnification by Cipher. Cipher agrees to and hereby does indemnify, defend and hold the Distributor Indemnitees harmless from and against all losses, claims, damages, costs and expenses, including reasonable attorneys’ fees that directly result from Third Party claims, actions or proceedings (collectively, “Losses”) arising from: (a) the breach of any representation, warranty, covenant or obligation by Cipher hereunder (except for that relating to infringement indemnification, the provisions for which are exclusively limited to Section 7.5), (b) any negligent act or omission, or wilful misconduct of Cipher or its Affiliates or any of its Approved Manufacturers or, as applicable, any of its Contract Finishers, (e) the Marketing of the Product inside the Territory by or on behalf of Cipher or any of its Affiliates (other than by Distributor or SubDistributors), or (d) the death or injury to any person or damage to property resulting from the failure of Cipher, its Affiliates or any of its Approved Manufacturer or Contract Finisher to Manufacture, Package, store or ship the Product in accordance with cGMP, the Regulatory Approvals or other applicable Laws, except to the extent such death or injury to person or property is due to a circumstance described in Section 10.2 hereof.

 

10.2        Indemnification by Distributor. Distributor agrees to and hereby does indemnify and hold the Cipher Indemnitees harmless from and against all Losses arising from: (a) the breach of any representation, warranty, covenant or obligation by Distributor, its Affiliates or any SubDistributor hereunder, or (b) the death or injury to person or damage to property resulting from (i) sale or use of a pharmaceutical product which is not supplied by or on behalf of Cipher or any of its Approved Manufacturers or any of their respective Affiliates or agents pursuant to this Agreement and which is sold or combined by Distributor or any SubDistributor with the Product, (ii) the improper handling, storage or transport of the Product by Distributor, its Affiliates, or any SubDistributor or their respective agents, (iii) the unauthorized alteration, modification, or adulteration of the Product by Distributor, its Affiliate, or any SubDistributor, (iv) any representations or warranties made by Distributor or any of its Affiliates or SubDistributors with respect to the Product (other than the Packaging approved by the Regulatory Authority), except in any such case to the extent such death or injury to person or property is due to a circumstance described in Section 10.1(d) hereof.

 

10.3        Procedure. The Party seeking indemnification under Sections 10.1 or 10.2 (the “Indemnified Party”) shall promptly notify the other Party (the “Indemnifying Party”) in writing of all matters which may give rise to the right to indemnification hereunder; provided, however, that failure to promptly give the notice provided in this Section 10.3 shall not be a defense to the liability of the Indemnifying Party for such claim, unless the Indemnifying Party is prejudiced thereby. The Indemnified Party shall not admit any liability with respect to, or settle, compromise or discharge any such matter covered by this Article 10. The Indemnifying Party shall have the right, with the consent of the Indemnified Party to settle all indemnifiable matters under this Article 10 related to claims by Third Parties which are susceptible to being settled, provided that no such consent of the Indemnified Party is required if the Indemnified Party is not required to make any admission of liability or is not financially compromised as a result of the settlement. In connection with any claim giving rise to indemnity under this Article 10 resulting from or arising out of any claim or legal proceeding by a Person other than the Indemnified Party, the Indemnifying Party at its sole cost and expense may, upon written notice to the Indemnified Party and an acknowledgement of its indemnity obligations hereunder, assume the defense of any such claim or legal

 

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proceeding. If the Indemnifying Party assumes the defense of any such claim or legal proceeding, the Indemnifying Party shall select counsel to conduct the defense of such claims or legal proceedings and, at the Indemnifying Party’s sole cost and expense (which costs and expenses shall not be applied against any indemnity limitation herein), shall take all steps necessary in the defense or settlement thereof. The Indemnified Party shall be entitled to participate in (but not control) the defense of any such action, with its own counsel and at its own expense, and shall be entitled to any and all information and documentation relating thereto. If the Indemnifying Party does not assume (or continue to diligently and competently prosecute) the defense of any such claim or litigation resulting therefrom in accordance with the terms hereof, the Indemnified Party may, at the Indemnifying Party’s reasonable expense, defend against such claim or litigation in such manner as it may deem appropriate, but may not settle such claim or litigation without the consent of the Indemnifying Party. The Indemnified Party will cooperate reasonably with the Indemnifying Party in its efforts to conduct or resolve such matters, including by making available to the Indemnifying Party relevant documents and witnesses. The Indemnified Party and the Indemnifying Party shall keep each other informed of all settlement negotiations with Third Parties and of the progress of any litigation with Third Parties. The Indemnified Party and the Indemnifying Party shall permit each other reasonable access to books and records and shall otherwise cooperate with all reasonable requests of each other in connection with any indemnifiable matter resulting from a claim by a Third Party.

 

10.4        Claims Related to Active Ingredient Side Effects. Cipher and Distributor agree to [***] any Losses incurred by either of them or any of the Distributor Indemnitees and the Cipher Indemnitees arising from any ADEs resulting from adverse side effects of the Active Ingredient (but excluding those side effects resulting a manufacturing defect or error) and each Party shall promptly notify the other Party in writing of any such claims and the Parties shall jointly agree and decide on a defense strategy and choice of counsel and shall share all costs related thereto. No settlement to such claims shall be made without the consent of both Parties.

 

10.5        Indemnification Not Sole Remedy. Each Party hereby acknowledges that the indemnification provided for under this Article 10 shall in no manner limit, restrict or prohibit (unless liability is otherwise expressly limited by the terms of this Agreement) either Party from seeking any recovery or remedy provided at law or in equity from the other Party in connection with any breach or default by such other Party of any representation, warranty or covenant hereunder, including injunctive relief for breach of Section 2.3.

 

10.6        Insurance. Each Party shall, and shall cause their respective Affiliates, SubDistributors, licensees and sublicensees, as required, upon the Effective Date and continuing throughout the Term and for a period of not less than [***] following the termination or expiration of this Agreement, carry or be subject to coverage (as a named insured) under product liability insurance in an amount of not less than [***] combined single limit, which insurance shall be written on a “claims-made” policy basis with an insurance carrier rated at least A- by Bests Rating Service or a comparable rating by a comparable rating service. Each Party shall provide the other Party with evidence of coverage contemplated hereby, in the form of certificates of insurance as reasonably requested in writing. Each Party shall provide written notice to the other Party fifteen (15) days prior to any material change, cancellation or non-renewal of the policy.

 

11.                               REPRESENTATIONS, WARRANTIES AND COVENANTS; LIMITATIONS OF LIABILITY

 

11.1        Representations, Warranties and Covenants of Both Parties.

 

(a)           Organization and Authority. Each Party represents and warrants that it (i) is duly organized, validly existing and in good standing under the Laws of the jurisdiction of its organization, (ii) is qualified to do business in each other’s jurisdiction in which the conduct of its business requires such

 

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qualification including the Territory, (iii) is in compliance with all applicable Laws, relating to its business and assets, and (iv) is not in material default of its memorandum or articles of association, its certificate of incorporation or by-laws or all other constituent documents as the case may be, except in the case of (ii) and (iii) where such failure to qualify or he in compliance would not have a material adverse effect on the business and assets of such Party or the performance of this Agreement by such Party.

 

(b)           Due Authorization and Enforceability. Each Party represents and warrants that (i) it has full authority to execute, deliver and perform its obligations under this Agreement, (ii) that this Agreement has been duly executed and delivered by such Party, and constitutes the legal, valid and binding obligations of such Party and is enforceable against such Party in accordance with its terms, and (iii) that the execution, delivery and performance of this Agreement will not violate, be inconsistent with or result in a default under or creation of lien or encumbrance under (except as specifically contemplated by this Agreement) (A) the memorandum or articles of association, certificate of incorporation or by-laws or other constituent documents, as the case may be, of any Party and/or its Affiliates, (B) any material agreement, contract, license understanding or instrument binding upon or affecting such Party or its properties or assets, whether express, implied, written or oral, or (C) any applicable Laws affecting either Party or its properties or assets, except where such violation would not have a material adverse effect on the business and assets of such Party.

 

(c)           Import and Product Handling. Each Party covenants that it will and will cause its Affiliates and agents and, in the case of Distributor, its SubDistributors, and, in the case of Cipher, its Approved Manufacturer(s) and, if applicable, Contract Finisher(s) to, comply with all applicable Laws relating to the importation, warehousing, storage, Manufacturing, Marketing, Packaging and Testing of the Product applicable to such Laws and will ensure that all required Approvals are in effect and will maintain such Approvals in good standing

 

(d)           Rights to Grant. Cipher represents and warrants that it has the sole, exclusive and unencumbered right to grant the rights (including any license) herein granted to Distributor, and that neither Cipher, nor to Cipher’s knowledge, any other Person has granted any option, license, right or interest in or to the Product to any Third Party which could conflict with the rights granted by it under this Agreement in the Territory.

 

(e)           Maintenance of Galephar Licenses and Rights. Cipher represents and warrants that the Galephar License Agreement in the form attached hereto as Schedule G is a true and complete copy of such agreement and that such agreement has not been subsequently amended, modified or supplemented. The Galephar License Agreement and all related agreements between Cipher and Galephar that relate to the Product, the Product Technology, the Product Patents and the Product Know-How are in full force and effect, and neither Cipher nor Galephar is in default under or in breach of any provision thereof. Cipher further represents and warrants that (i) it and Galephar are the sole parties to the Galephar License Agreement as a result of the merger of Cipher Pharmaceuticals Ltd. into Cipher; and (ii) to Cipher’s knowledge, the rights granted to it by Galephar are not and will not be subject to any security interest or agreement which could cause the licenses granted to it thereunder to be terminated. Cipher will maintain its licenses and rights from Galephar in good standing throughout the Term.

 

(f)            Trademarks. Cipher represents and warrants that, to its knowledge, it has all rights to the Cipher Trademarks and that such trademarks are valid. Distributor represents and warrants that, to its knowledge, it has all rights to the Trademarks and such trademarks are valid.

 

(g)           Intellectual Property. Cipher owns or has the exclusive worldwide license to all intellectual property (including all Intellectual Property), assets, licenses and approvals necessary to make, have made, use, sell, offer for sale and import the Products on an exclusive basis and will possess all such

 

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rights during the Term as may be necessary to promote, Market, Distribute and sell the Product in the Territory itself and/or through Distributor or its Affiliates as contemplated by this Agreement. Cipher further has the right and ability to initiate patent litigation against Third Parties based upon an alleged or suspected infringement of the Product Patents, and to require the joinder of Galephar in such litigation.

 

(h)           No Claims. Except as set forth in Schedule 11.1(h), Cipher represents and warrants that there has not been any proceeding at any time since the date of the Galephar License Agreement, and none is currently pending or, to the knowledge of Cipher, threatened against, Cipher or any of its Affiliates, relating to or otherwise arising from (i) product liability claims or claims for death or bodily injury relating to the Product, or (ii) infringement, misappropriation or other conflict with any intellectual property or other rights of any Person relating to the Product or any Cipher Trademarks, or (iii) the promotion, Marketing, Manufacture, Distribution or sale of the Product. To the knowledge of Cipher, Distributor’s Marketing, sale and Distribution of the Product as contemplated by this Agreement shall not infringe or otherwise violate the Intellectual Property rights of any Third Party.

 

(i)            Notice of Default and Amendments. Cipher covenants (i) that it will give Distributor notice of any breach or default, or claimed breach or default, of the Galephar License Agreement within two (2) days of when it receives or provides a notice of breach or default, (ii) that it will not waive or amend any provision of the Galephar License Agreement (to the extent such amendment or waiver specifically impacts the Product) or terminate the Galephar License Agreement, in each case, without the prior written consent of Distributor, (iii) in the event Galephar is the subject of a case or proceeding under Title 11 of the United States Code or similar case or proceeding under foreign law, Cipher will elect to continue as licensee to Galephar’s intellectual property. To the extent Cipher defaults under the Galephar License Agreement due to Cipher’s failure to make payments to Galephar owing thereunder, Distributor shall have the right to pay Galephar directly for such amounts and to set-off any monies owed by Distributor to Cipher by such amounts paid to Galephar by Distributor.

 

11.2        No Other Warranties. The warranties of Cipher set forth in this Article 11 are in lieu of all other warranties, express or implied, and specifically, without limitation, Cipher disclaims any implied warranty of merchantability or fitness for a particular purpose.

 

11.3        Quality Assurance Representations, Warranties and Covenants.

 

(a)           Cipher, in its own name and on behalf of any of its Approved Manufacturers, Contract Finishers and Affiliates engaged in the performance of the actions contemplated hereby, including the Manufacture, sale and delivery of Product hereunder, hereby represents, warrants and covenants to Distributor that all Product or Authorized Generic that Cipher or any of Cipher’s Approved Manufacturers or Affiliates Manufactures, supplies and delivers under and pursuant to this Agreement will:

 

(i)            conform in all material respects to the Specifications at time of release;

 

(ii)           be free and clear from all material liens, encumbrances and defects of title, other than those that arise directly as a result of actions taken by Distributor; and

 

(iii)          comply with the requirements under the GMP standards, the Regulatory Approvals and the Other Approvals, as applicable, the Act and any other applicable Law in the Territory, and will not, at the time of such delivery, (i) be adulterated or misbranded within the meaning of the Act, or (ii) be an article which may not, under the provisions of the Act, be introduced into interstate commerce.

 

(iv)          shall furnish to Distributor a certificate of analysis for each lot of the Product shipped to Distributor, and a certificate that such lot meets the quality control standards set forth

 

34

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

in the relevant approved application for Regulatory Approval all well as the annual certificate of compliance.

 

(b)           Distributor shall be responsible for storing Product under appropriate conditions as specified in labelling and for Marketing, Testing, Distribution and sale in full compliance with the applicable GMP standards, the Regulatory Approvals, the Other Approvals, the Act and the applicable Law. Distributor shall have received and shall be in current compliance with all Approvals of any Authority as may be required to Market the Product pursuant to this Agreement.

 

(c)           None of Distributor, Distributor’s Affiliates or SubDistributors shall, in bad faith, disrupt or cause the disruption of the supply of the Product into the marketplace in the Territory.

 

(d)           Cipher or its Approved Manufacturer(s) shall have received, and shall be in current compliance with, all Approvals of any Regulatory Authority as may be required to Manufacture and/or to supply the Product pursuant to this Agreement, and, as of the Effective Date, Cipher or, to its knowledge, any Approved Manufacturer has not received any warning letters or similar regulatory letters from any Regulatory Authority within the last three years with respect to the Product which Cipher has not disclosed to Distributor or which prevents the Manufacture and supply of the Product. The NDA has been approved and such approval is currently in full force and effect.

 

(e)           Each Party represents and warrants to the other Party that it has not engaged in any conduct or activity which could justify a Regulatory Authority debarment action, and no disbarment proceedings are currently underway or, to its knowledge, contemplated against it or any of its employees and, to its knowledge, neither its Approved Manufacturer nor any of its Contract Finishers has engaged in conduct that would justify a Regulatory Authority disbarment action and no proceedings are currently underway or contemplated against any of its Approved Manufacturers or Contract Finishers or any of their employees.

 

11.4        Limitation of Liability. Except in the case of fraud or wilful misconduct on behalf of any Party, in no event shall either Party or its Affiliates be liable to the other Party in connection with this Agreement for any indirect, incidental, punitive or special damages, including loss of profits, goodwill or revenue, data or use, whether in contract or tort or based on a warranty, even if a Party has advised the other Party of the possibility of such damages.

 

12.                               MISCELLANEOUS

 

12.1        Governing Law. This Agreement shall be governed by laws of New York, excluding its choice of law provisions. The Parties hereby agree to exclude the application of the International Sale of Goods Act.

 

12.2        Dispute Resolution. The Parties recognize that any dispute, controversy or claim arising under or relating to this Agreement, excluding any claims relating to patent scope, validity or infringement, (collectively, a “Dispute”) may from time to time arise during the Term of this Agreement. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this Section 12.2 if and when a dispute arises under this Agreement. Each Party shall designate an individual (the “Responsible Person”) to whom disputes shall be initially referred. Such Responsible Person shall be (i) in the case of Cipher, a person having managerial responsibility in the functional area of dispute and (ii) in the case of Distributor, a person having direct reporting responsibility to the Chief Executive Officer of Distributor. Disputes under this Agreement between the Parties shall be submitted to the other Party’s Responsible Person. The Responsible

 

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Persons will meet and hear the disputed matter in as timely a manner as possible. If the Responsible Persons are unable to reach a decision within ten (10) days, such matter shall be referred for resolution to the Chief Executive Officer of Cipher and the Chief Executive Officer of Distributor (or such other officer exercising the duties of such office). Such submission shall be made with each Party submitting a statement as to the disputed matter and the Responsible Persons providing a joint statement as to which matters they were unable to agree upon. In the event that a dispute is not resolved by the foregoing procedures within thirty (30) days of first being submitted by a Party, the Responsible Persons shall select a mediator with appropriate expertise in the subject matter to which the dispute relates who will be engaged to attempt to resolve the dispute. Such mediation shall be conducted using the Commercial Mediation Procedures of the American Arbitration Association. If the Parties are unable to resolve their dispute through mediation within forty-five (45) days after selection of the mediator, the matter shall be finally settled exclusively by arbitration under the International Arbitration Rules of the American Arbitration Association (the “Rules”), provided however that nothing herein shall prevent or prohibit any Party from seeking injunctive/equitable relief in any court within appropriate jurisdiction. Either Party may, by written notice to the other, have a Dispute referred to arbitration. Unless otherwise agreed in writing, any arbitration shall be conducted in the English language and shall be held in New York City, New York, and heard by a panel of three (3) arbitrators. Each party shall nominate one arbitrator. The third arbitrator, who will be chairman of the arbitral tribunal, shall be appointed in accordance with the Rules. The decision and award of the arbitral tribunal shall be final and binding and may be entered in any court of competent jurisdiction, for which purpose, and for all other purposes under this Agreement, including matters relating to injunctive or equitable relief, each party hereto submits to the jurisdiction and venue of the U.S. District Court for the Southern District of New York. The costs of any such arbitration shall be allocated as follows: (i) if the arbitrators rule in favor of one Party on all disputed issues in the arbitration, the losing Party shall pay 100% of such fees and expenses; and (ii) if the arbitrators rule in favour of one Party on some issues and the other Party on other issues, the arbitrators shall issue with the ruling a written determination as to how such fees and expenses shall be allocated between the Parties. The arbitrators shall allocate fees and expenses in a way that bears a reasonable relationship to the outcome of the arbitration, with the Party prevailing on more issues, or on issues of greater value or gravity, recovering a relatively larger share of its legal fees and expenses. Each Party is required to continue to perform its obligations under this Agreement pending final resolution of the Dispute. In no event will a demand for arbitration hereunder be made after the date when institution of a legal or equitable proceeding based upon such Dispute would otherwise be barred by the applicable statute of limitations. Nothing herein shall preclude either Party from seeking injunctive relief against the other Party in a court of law.

 

12.3        Entire Agreement; Amendments. This Agreement, including the Schedules hereto, sets forth the entire terms of the supply and distribution arrangement between the Parties hereto and, except as otherwise set forth herein, supersedes and terminates all prior agreements and understandings between the Parties. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.

 

12.4        Notices. When a Party is required or permitted to give notice under this Agreement, the notice shall be in writing, shall specifically refer to this Agreement and shall be deemed to have been sufficiently given and received for all purposes within (i) two (2) days if the Party sent the notice by internationally recognized express delivery service, (ii) one (1) day if the Party sent the notice by facsimile transmission, with transmission confirmed, or (iii) immediately if the Party personally delivered the notice. Unless otherwise specified in writing, the mailing addresses of the Parties shall be as described below.

 

	
For Cipher:
    	
 
    	
Cipher Pharmaceuticals Inc.
    
	
 
    	
 
    	
5650 Tomken Road, Unit 16
    
	
 
    	
 
    	
Mississauga Ontario 1.4W 4P1
    

 

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Facsimile: 
    
	
 
    	
 
    	
Attention: Larry Andrews
    
	
 
    	
 
    	
 
    
	
With a copy sent
    	
 
    	
 
    
	
simultaneously to:
    	
 
    	
Torys LLP
    
	
 
    	
 
    	
79 Wellington Street W
    
	
 
    	
 
    	
Toronto, Ontario M5K 1N2
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
Facsimile: 
    
	
 
    	
 
    	
Attention: Cheryl Reicin
    
	
 
    	
 
    	
 
    
	
For Distributor:
    	
 
    	
Vertical Pharmaceuticals Inc.
    
	
 
    	
 
    	
2400 Main Street, Suite 6
    
	
 
    	
 
    	
Sayreville, New Jersey 08872, U.S.A.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
Facsimile: 
    
	
 
    	
 
    	
Attention: Greg Voyles
    
	
 
    	
 
    	
 
    
	
With copies sent
    	
 
    	
 
    
	
simultaneously to:
    	
 
    	
Waller Lansden Dortch & Davis, LLP
    
	
 
    	
 
    	
511 Union Street, Suite 2700
    
	
 
    	
 
    	
Nashville, Tennessee 37219, U.S.A
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
Attention: Hunter Rost, Esq.
    
	
 
    	
 
    	
Facsimile: 
    

 

12.5        Assignment. Neither Party shall assign or otherwise transfer this Agreement or any interest herein or right or obligation hereunder without the prior written consent of the other Party and any such purported assignment, transfer or attempt to assign or transfer any interest herein or right hereunder shall be void and of no effect; provided, however, that a Party may assign its rights and obligations hereunder to an Affiliate or to a transferee or acquirer of, or successor to, its assets or securities in the event of a merger, sale of stock, sale of assets or other transaction without the prior consent of the other Party; provided, further that (i) in the case of an assignment to an Affiliate, the assigning Party shall remain responsible for all of its obligations and agreements set forth herein, notwithstanding such assignment, and (ii) in the case of a merger, sale of stock, sale of assets or other transaction, such transferee or successor shall assume in writing the obligations of the party to which it is the transferee or successor; and (iii) either Party may have its Affiliates perform its obligations hereunder; provided that the delegating Party shall remain responsible for all of its obligations and agreements set forth herein, notwithstanding such delegation. Notwithstanding the foregoing, Cipher shall have the right to terminate this Agreement in the event that Distributor makes any assignment or transfer through merger, sale stock, sale of assets or otherwise, to any person or entity that directly or indirectly, through Affiliates, SubDistributors or otherwise, Markets a Competing Product in the Territory.

 

12.6        Public Announcements. Neither Party shall make any publicity releases, conduct interviews or otherwise disseminate Confidential Information concerning (i) the Product (the purpose of which is not advertisement or promotion), (ii) this Agreement or its terms, or (iii) either Party’s performance hereunder, to communication media, financial analysts or others, in each case, without the prior written approval of the other Party. Either Party may, upon written notice to the other, make any disclosure in filings with Authorities as required by Law or applicable court or other order; provided, however, that the other Party shall have not less than three (3) Business Days to review and comment on such disclosures and filings unless a shorter period is necessitated by securities laws.

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

12.7        Severance. If any Official Body Or Regulatory Authority having jurisdiction over either Cipher or Distributor declares any Article or part thereof invalid or any such Official Body or Regulatory Authority deems any Article or part thereof to be contrary to any Laws, then such Article or part thereof shall be deemed stricken from this Agreement in that jurisdiction. To the extent possible the Parties shall revise such invalidated Article or part thereof in a manner that will render such provision valid without impairing the Parties’ original intent.

 

12.8        Non-Waiver. The failure of a Party in any one or more instances to insist upon strict performance of any of the terms and conditions of this Agreement shall not be construed as a waiver or relinquishment, to any extent, of the right to assert or rely upon any such terms or conditions on any future occasion. Except as otherwise specified, all rights, remedies, undertakings, obligations and agreements contained in this Agreement shall be cumulative and none of them shall be a limitation of any other remedy, right, undertaking, obligation or agreement.

 

12.9        Further Documents. Each Party hereto agrees to execute such further documents and take such further steps as the other Party reasonably determines may be necessary or desirable to effectuate the purposes of this Agreement.

 

12.10      Force Majeure. No Party shall be in breach of this Agreement, or liable to the other Party, for any delay or failure of performance to the extent such delay or failure is caused by Force Majeure, provided that the Party claiming Force Majeure gives prompt written notice to the other Party of the occurrence of an event of Force Majeure and uses its Commercially Reasonable Efforts to overcome the same. In the event of Force Majeure, the Parties agree to discuss the circumstances and effects thereof, including the effects on Distributor’s obligations under this Agreement, and appropriate mechanisms to address such circumstances and effects.

 

12.11      Foreign Corrupt Practices Act. Cipher and Distributor each agrees that it shall comply with the requirements of the U.S. Foreign Corrupt Practices Act or any successor Law or Law to similar effect (the “Foreign Corrupt Practices Act”) and shall refrain from any payments to Third Parties or any other acts or omissions which would cause Cipher or Distributor to violate the Foreign Corrupt Practices Act.

 

12.12      Disclaimer of Agency. This Agreement shall not constitute either Party the legal representative or agent of the other Party, nor shall either Party have the right or authority to assume, create, or incur any Third Party liability or obligation of any kind, express or implied, against or in the name of or on behalf of another except as expressly set forth in this Agreement. None of Distributor, its directors, officers, agents or employees shall be considered employees agents or legal representatives of Cipher for any purpose.

 

12.13      Construction. The language in all parts of this Agreement shall be construed, in all cases, according to its fair meaning. The Parties acknowledge that each Party and its counsel have reviewed and revised this Agreement and that any rule of construction to the effect that any ambiguities are to be resolved against the drafting Party shall not be employed in the interpretation of this Agreement. The words “hereof’, “herein”, “hereto” and “hereunder” and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provision of this Agreement. The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa. The terms “dollars” and “S” shall mean United States dollars. Whenever used herein, the words “include”, “includes” and “including” shall mean ‘include, without limitation,” “includes, without limitation” and “including, without limitation,” respectively, even when not explicitly so stated. The masculine, feminine or neuter gender and the singular or plural number shall each be deemed to include the others whenever the context on indicates.

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Whenever in this Agreement the consent or approval of a Party is required or permitted, such consent or approval shall not be unreasonably withheld, conditioned or delayed.

 

12.14      Counterparts. This Agreement shall become binding when any one or more counterparts hereof, individually or taken together, shall bear the signatures of each of the Parties hereto. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original as against the Party whose signature appears thereon, but all which taken together shall constitute but one and the same document.

 

12.15      TriGen Laboratories, Inc. TriGen Laboratories, Inc., a New Jersey corporation under common ownership with Distributor (“TriGen”), hereby joins this Agreement for the sole purpose of this Section 12.15, and agrees that to the extent Distributor requires additional funds to perform its obligations under Articles 2, 3, 4, 5, 6, 9 and 10 of this Agreement at any time during the Sales Commitment Period, TriGen will make additional funding available to Distributor. TriGen shall not be obligated to perform or engage in any Marketing or other obligations of Distributor hereunder.

 

Signature Page Follows

 

39

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

IN WITNESS WHEREOF, the Parties hereto have duly executed this Agreement as of the date first written above.

 

	
CIPHER PHARMACEUTICALS INC.
    	
 
    	
VERTICAL PHARMACEUTICALS INC.
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Larry Andrews
    	
 
    	
By:
    	
/s/ Steven Squashic
    
	
Name:
    	
Larry Andrews
    	
 
    	
Name:
    	
Steven Squashic
    
	
Title:
    	
President and Chief   Executive Officer
    	
 
    	
Title:
    	
President
    

 

For Purposes of Section 12.15:

 

TRIGEN LABORATORIES, INC.

 

	
By:
    	
/s/ Kevin Hudy
    	
 
    	
 
    	
 
    
	
Name:
    	
Kevin Hudy
    	
 
    	
 
    	
 
    
	
Title:
    	
President
    	
 
    	
 
    	
 
    

 

[SIGNATURE PAGE TO DISTRIBUTOR AND SUPPLY AGREEMENT]

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

SCHEDULE A

 

CIPHER TRADEMARKS

 

“CONZIP” (USPTO Reg. No. 85175001)

 

Schedule A-1

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

SCHEDULE B

 

PRODUCT INFORMATION

 

PRODUCT STRENGTHS AND TRADE DRESS:

 

CONZIPTM: 100mg, 150 mg, 200mg, and 300mg strengths

 

	
Product
    	
 
    	
Strength
    	
 
    	
Description
    
	
COnZIPTM extended release capsules
    	
 
    	
100 mg
   Pack Sizes: 5 and 30
    	
 
    	
Size: 1
    Color: White Opaque Cap and Body
    Marking: “0252” on cap, “100” between   lines on body in blue ink
    
	
ConzipTM extended release capsules
    	
 
    	
150 mg
   Pack Sizes: 5 and 30
    	
 
    	
Size: 0
    Color: White Opaque Cap and Body
    Marking: “0322” on cap, ‘150” between   lines on body in golden ink
    
	
ConzipTM extended release capsules
    	
 
    	
200 mg
   Pack Sizes: 5 and 30
    	
 
    	
Size: 0
    Color: White Opaque Cap and Body
    Marking: “0253” on cap, “200” between   lines on body in violet ink
    
	
ConzipTM extended release capsules
    	
 
    	
300 mg
   Pack Sizes: 5 and 30
    	
 
    	
Size: 00
    Color: White Opaque Cap and Body
    Marking: “G254” on cap, “300” between   lines on body in red ink
    

 

PATENT:

 

The Product is supported by U.S. patent 78581 I 8B2 issued on December 28, 2010

 

MINIMUM BATCH REQUIREMENTS:

 

100 mg dosage                                      =                                         [***] capsules

150 mg dosage                                      =                                         [***] capsules

200 mg dosage                                      =                                         [***] capsules

300 mg dosages                                 =                                         [***] capsules

 

Schedule B-1

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

SCHEDULE C

 

PAYMENTS TO CIPHER

 

Part A
 Up-Front Payment

 

In consideration of the rights granted to Distributor under Section 2.1 of the Agreement, Distributor will pay to Cipher a non-refundable payment of [***] payable June 30, 2011 (the “Up-Front Payment”).

 

Part B
 Sales Milestone Payments

 

Distributor will make the following one time, non-refundable Sales Milestone Payments to Cipher:

 

(i)                                     [***] upon the First Commercial Sale of the Product.

 

(ii)                                  [***] when Net Sales exceed [***] in a single twelve (12) month period.

 

(iii)                               An additional [***] when Net Sales exceed [***] in a single twelve (12) month period.

 

(iv)                              An additional [***] when Net Sales exceed [***] in a single twelve (12) month period.

 

Sales Milestone Payments shall be doe and payable thirty (30) days following the month in which the applicable sales milestone has been achieved. The calculation of Net Sales for purposes of the Sales Milestone Payments shall be subject to the Net-to-Gross Floors set forth in Part D below.

 

Part C
 Purchase Price

 

The Purchase Price for Product supplied by Cipher shall be payable within thirty (30) days of the date title to the Product is passed in accordance with Section 6.5.

 

Part D
 Royalty Payments to Cipher

 

Within 30 days after the end of each fiscal quarter, Distributor shall (A) deliver to Cipher a statement, certified by Distributor’s Chief Financial Officer, containing, by dosage strength, the number of Units sold, the Gross Sales and the Net Sales for each dosage strength of Product during the such quarter, including details of all necessary calculations of the same, including the calculations which detail the differences between Net Sales and Gross Sales; (B) deliver to Cipher a statement of amount of inventory of the Product held by Distributor as of the last day of each quarter and all statements of inventory of the Product received by Distributor from any wholesaler as oldie end of such quarter; and (C) remit to Cipher a royalty payment equal to [***] of Distributor’s Net Sales during such fiscal quarter (the “Royalty Payment”). Notwithstanding the foregoing, for the purpose of calculating the Royalty Payments, Net Sales as a percentage of Gross Sales shall not be less than the following floor percentage (“Net-to-Gross Floors”):

 

(i)                                     [***]

 

Schedule C-1

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

SCHEDULE D

 

DISTRIBUTOR’S MINIMUM NET SALES REQUIREMENT

 

 

	
Twelve (12) month period
    	
 
    	
Minimum Net Sales Requirement
    
	
Ending on the second (2nd ) anniversary of the First   Commercial Sale having been achieved (“Fiscal Year 2”)
    	
 
    	
[***]
    
	
Ending on the third (31 anniversary of the First   Commercial Sale having been achieved (“Fiscal Year 3”)
    	
 
    	
[***]
    
	
Ending on the fourth (4) anniversary of the   First Commercial Sale having been achieved (“Fiscal Year 4”)
    	
 
    	
[***]
    

 

Distributor shall not be subject to any Minimum Net Sales Requirements either during the first (1st) year following the First Commercial Sale or any time after the fourth (0) year anniversary of the First Commercial Sale If Distributor fails to achieve the Minimum Net Sales Requirement for any of Fiscal Years Two, Three or Four, Cipher shall have the right to terminate the Agreement upon ninety (90) days notice to Distributor, which notice, if given, shall be delivered to Distributor within sixty (60) days following Cipher’s receipt from Distributor of total Net Sales results for such year.

 

In the event the Regulatory Approval necessary to Market the Product in the Territory is revoked or suspended other than by reason of a material breach of the Agreement by Distributor, Distributor’s obligations to meet Minimum Net Sales Requirements shall be held in abeyance until such Regulatory Approval is reinstated or another Regulatory Approval to Market in the Territory is obtained.

 

In the event of a supply disruption as provided in Section 6.6 of the Agreement, Distributor’s obligations to meet Minimum Net Sales Requirements shall be held in abeyance until all of Distributor’s outstanding purchase orders for Product have been supplied.

 

Distributor shall have no further obligations hereunder if a Generic Equivalent of a Third Party becomes available for sale in the Territory.

 

Schedule D-1

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

SCHEDULE F

 

COST OF GOODS SOLD

 

The following is the actual Product cost of goods sold for finished and packaged/labelled Product associated with purchase orders received prior to December 31, 2011(“Cost of Goods Sold”) and in accordance with the provisions set out in Section 6.2(a). Cost of Goods Sold increases will occur annually on January 1st in each year throughout the Term commencing on January 1st 2012, based on the year over year change in Producer Price Index for Pharmaceutical Products as produced by the Bureau of Labor Statistics for the twelve month period ending on October 31st of the prior year. If the year over year change in the index is negative then the amount of the Cost of Goods Sold will not change for the next year. Any increase in Cost of Goods Sold shall only apply for purchase orders received after the effective date of the increase. These prices are based on the minimum batch sizes for each strength outlined in Schedule B of this Agreement.

 

Product Unit Price $USD

 

	
Bottle
   Size
    	
 
    	
100 mg*
    	
 
    	
150 mg*
   TBD
    	
 
    	
200 mg*
    	
 
    	
300 mg*
    
	
5
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
7
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
30
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
90
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

Schedule F-1

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

SCHEDULE 11.1(H)

 

CLAIMS

 

CHRONOLOGY OF CIPHER TRAMADOL LITIGATION

 

·                  On or about April 14, 2008, Cipher Pharmaceuticals Inc. (“Cipher”) submitted New Drug Application No. 22-370 (the “Cipher NDA”) to the U.S. Food and Drug Administration seeking approval for Tramadol Hydrochloride Extended Release Capsules 100 mg, 200 mg and 300 mg (“Cipher’s NDA Products”),

 

·                  On or about August 14, 2009, after a full trial on the merits in litigation involving Par Pharmaceutical, Inc., Judge Kent A.  Jordan of the United States Court of Appeals for the Third Circuit, sitting by designation in the United States District Court for the District of Delaware, issued an opinion holding the asserted and adjudicated claims of U.S. Patent No. 6,254,887 (“‘887 patent”) and U.S. Patent No. 7,074,430 (“‘430 patent”) invalid for obviousness.  Purdue Pharma Prods., L.P. v. Par Phanri., Inc., 642 F. Supp. 2d 329 (D. Del. 2009) (the “Par decision”).  Purdue Pharma Products L.P. and Napp Pharmaceutical Group Ltd. (collectively, “Purdue”) immediately appealed this decision to the United States Court of Appeals for the Federal Circuit (the “Federal Circuit”).

 

·                  On or about September 15, 2009, Cipher sent the required letter (“Cipher’s P1V Notice Letter”) to, among others, Purdue notifying Purdue that Cipher had filed the Cipher NDA and that Cipher had submitted a so-called “paragraph IV certification” stating that, in Cipher’s opinion and to the best of its knowledge, the ‘887 patent was invalid, unenforceable and/or not infringed, and that Cipher sought final FDA approval to market Cipher’s NDA Products prior to expiration of the ‘887 patent.(1)

 

·                  On or about October 30, 2009, in response to Cipher’s PIV Notice Letter, Purdue filed a Complaint against Cipher in the United States District Court for the Eastern District of Virginia (the “Virginia Court”) alleging that Cipher’s NDA Products would infringe the ‘887 and ‘430 patents.  Purdue Pharma Products L.P. and Napp Pharmaceutical Group Ltd. v. Cipher Pharmaceuticals Inc., Civil Action No. No. 2:09-cv-00544-RBS-JEB (E.D.V.A.) (the “Cipher Action”).

 

·                  On or about December 2, 2009, Cipher filed a motion to dismiss the Cipher Action in its entirety, and for summary judgment in favor of Cipher, on the ground that the ‘887 and ‘430 patents have already been adjudicated invalid for obviousness (in the Par decision), thus precluding Purdue from pursuing the Cipher Action under the doctrine of collateral estoppel.

 

·                  On or about December 30, 2009, the Virginia Court entered a stipulated order and final judgment in favor of Cipher in the Cipher Action, holding that the ‘887 and ‘430 patents are invalid for obviousness under 35 U.S.C. § 103 based on collateral estoppel arising from the Par decision.  Purdue did not appeal this decision.

 

·                  On or about June 3, 2010, the Federal Circuit issued a decision affirming the Par decision and upholding the invalidity of the ‘887 and ‘430 patents.

 

(1)  Cipher was not required to submit a paragraph IV certification to the ‘430 patent.

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