Document:

Exhibit 10.3

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

EXECUTION COPY

 

ASSET PURCHASE AGREEMENT

 

between

 

TARO PHARMACEUTICALS NORTH AMERICA, INC.

 

and

 

STRONGBRIDGE BIOPHARMACEUTICALS PLC

 

Dated

 

December 12, 2016

 

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

ASSET PURCHASE AGREEMENT

 

TABLE OF CONTENTS

 

	
 
    	
 
    	
Page
    
	
Page
    	
 
    	
i
    
	
 
    	
 
    	
 
    
	
ARTICLE I —   DEFINITIONS
    	
1
    
	
1.1
    	
Definition
    	
1
    
	
1.2
    	
Interpretation
    	
7
    
	
 
    	
 
    	
 
    
	
ARTICLE II —   PURCHASE AND SALE
    	
7
    
	
2.1
    	
Purchase and Sale
    	
7
    
	
2.2
    	
Liabilities
    	
8
    
	
2.3
    	
Trademark License
    	
8
    
	
2.4
    	
License
    	
9
    
	
2.5
    	
Regulatory Approval   Transfer; Retained Rights
    	
10
    
	
2.6
    	
Non-Compete
    	
10
    
	
 
    	
 
    	
 
    
	
ARTICLE III —   PAYMENTS/REPORTS/AUDITS
    	
11
    
	
3.1
    	
Purchase Price
    	
11
    
	
3.2
    	
Sales Reports
    	
12
    
	
3.3
    	
Audits
    	
12
    
	
3.4
    	
Taxes
    	
12
    
	
3.5
    	
Interest
    	
13
    
	
3.6
    	
Indemnity
    	
13
    
	
 
    	
 
    	
 
    
	
ARTICLE IV —   COVENANTS AND AGREEMENTS
    	
13
    
	
4.1
    	
Supply of Inventory   Units
    	
13
    
	
4.2
    	
Transition for Existing   Patients
    	
14
    
	
4.3
    	
Marketing Commitment
    	
15
    
	
4.4
    	
Non-Assignability
    	
15
    
	
4.5
    	
Minimum Purchase Quantities
    	
15
    
	
4.6
    	
Reversion Conditions
    	
15
    
	
4.7
    	
Use of Names
    	
16
    
	
4.8
    	
Removal of Taro Name   from Tablet
    	
16
    
	
4.9
    	
Patient Data
    	
16
    
	
4.10
    	
Development by Taro
    	
16
    
	
4.11
    	
Provision of   Information
    	
17
    

 

i

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

	
4.12
    	
Government Reporting   and Payment
    	
17
    
	
 
    	
 
    	
 
    
	
ARTICLE V —   EXECUTION, CLOSING AND EFFECTIVENESS
    	
17
    
	
5.1
    	
Execution; Closing
    	
17
    
	
5.2
    	
Further Assurances
    	
18
    
	
5.3
    	
Broker Fees
    	
18
    
	
 
    	
 
    	
 
    
	
ARTICLE VI — REPRESENTATIONS   AND WARRANTIES
    	
18
    
	
6.1
    	
Taro’s Representations   and Warranties
    	
18
    
	
6.2
    	
Strongbridge’s   Representations and Warranties
    	
19
    
	
6.3
    	
Disclaimer of Other   Warranties
    	
20
    
	
 
    	
 
    	
 
    
	
ARTICLE VII —   INDEMNIFICATION
    	
20
    
	
7.1
    	
Indemnification by Taro
    	
20
    
	
7.2
    	
Indemnification by   Strongbridge
    	
20
    
	
7.3
    	
Indemnification; Notice   and Settlements
    	
21
    
	
 
    	
 
    	
 
    
	
ARTICLE VIII —   MISCELLANEOUS
    	
21
    
	
8.1
    	
Notices
    	
21
    
	
8.2
    	
Expenses
    	
22
    
	
8.3
    	
Termination; Survival
    	
22
    
	
8.4
    	
Section 365(n) of   the Bankruptcy Code
    	
23
    
	
8.5
    	
Bulk Sales Statutes
    	
23
    
	
8.6
    	
Successors and Assigns
    	
23
    
	
8.7
    	
Entire Agreement;   Amendment
    	
23
    
	
8.8
    	
Public Announcement
    	
23
    
	
8.9
    	
Filing Requirements
    	
23
    
	
8.10
    	
Compliance with   Applicable Law
    	
24
    
	
8.11
    	
Governing Law;   Jurisdiction
    	
24
    
	
8.12
    	
Dispute Resolution
    	
24
    
	
8.13
    	
Language
    	
25
    
	
8.14
    	
Article Headings
    	
25
    
	
8.15
    	
Further Assurances
    	
25
    
	
8.16
    	
Waiver
    	
25
    
	
8.17
    	
Modification
    	
25
    
	
8.18
    	
Severability
    	
25
    
	
8.19
    	
Counterparts
    	
26
    
	
8.20
    	
No Third Party   Beneficiaries
    	
26
    

 

ii

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

ASSET PURCHASE AGREEMENT

 

TABLE OF SCHEDULES AND EXHIBITS

 

Schedule 1(a) Marketing Materials

Schedule 1(b) Product Trademark

Schedule 2.1(a)(ii) Domain Names

Schedule 4.3 Marketing Commitment

Schedule 5.1(b) FDA NDA Letter

Schedule 5.1(b) FDA NDA Letter

Schedule 5.1(b) Orphan Designation Acceptance Letter

Schedule 5.1(b) FDA IND Letter

 

iii

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

ASSET PURCHASE AGREEMENT

 

This Asset Purchase Agreement dated December 12 2016, is by and between Taro Pharmaceuticals North America, Inc., a Cayman Islands limited company, with a place of business at Harbour Place, 103 South Church Street, Grand Cayman KY1-1202, Cayman Islands (“Taro”) and Strongbridge Biopharmaceuticals plc, a company organized under the laws of Ireland, having its Company’s registered office at Arthur Cox Building, Earlsfort Terrace, Dublin 2, Ireland and having its principal U.S. place of business at 900 Northbrook Drive, Suite 200, Trevose, PA 19053 (“Strongbridge”).

 

WHEREAS, Taro’s Affiliate acquired the rights, title and interest to the Regulatory Approval pursuant to the Merck Agreements (defined below) which Regulatory Approval was subsequently transferred to Taro;

 

WHEREAS, Strongbridge desires to purchase and Taro desires to sell to Strongbridge, the Regulatory Approval, subject to a reversionary right to Taro of the Regulatory Approval upon the occurrence of the Reversion Conditions (defined below);

 

WHEREAS, Strongbridge desires to Commercialize (defined below) the Product (defined below) and Lifecycle Product (defined below) under the Product Trademark which is registered to Taro;

 

WHEREAS, Strongbridge desires to obtain an exclusive license to the Product Trademark for Commercialization of the Product and Lifecycle Product  in the Territory, and Taro is willing to grant such exclusive license for such purpose, pursuant to the terms and conditions set forth herein; and

 

WHEREAS, Taro and Strongbridge have entered into a Supply Agreement, dated as of the Effective Date, pursuant to which Taro shall supply, and Strongbridge shall purchase, Strongbridge’s, and its Affiliates’ requirements of Product (the “Supply Agreement”), pursuant to the terms and conditions set forth therein.

 

THEREFORE, in consideration of the mutual covenants and agreements provided herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, hereby agree as follows:

 

ARTICLE I — DEFINITIONS

 

1.1          Definition.  As used in this Agreement, the following terms, whether used in the singular or plural, shall have the following meanings:

 

“AAA” has the meaning set forth in Section 8.12(b).

 

“Affiliate” means any Person that controls, is controlled by, or is under common control with a Party.  For purposes of this definition, “control” means: (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a

 

1

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

particular jurisdiction) entitled to vote for the election of directors or otherwise having the power to vote on or direct the affairs of such Party; and (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest or the power to direct the management and policies of such non-corporate entities.  With respect to Taro, Affiliate means the following entities:  Taro Pharmaceutical Industries Ltd., Taro International Ltd., Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceutical Laboratories, Inc., Taro Pharmaceuticals Inc., Taro Pharmaceuticals Canada, Ltd., Taro Pharmaceuticals North America, Inc., Taro Pharmaceuticals Europe B.V., Taro Pharmaceuticals (UK) Limited, Taro Pharmaceuticals Ireland Limited, and Taro Hungary KFT, provided that any entity that, after the Effective Date is newly under the control of Taro Pharmaceutical Industries Ltd. or any of the foregoing entities shall be an Affiliate of Taro for purposes of this definition.

 

“Agreement” means this Asset Purchase Agreement including all exhibits, schedules and appendices attached hereto.

 

“Agreement Payments” has the meaning set forth in Section 3.4(a).

 

“API” means the active pharmaceutical ingredient dichlorphenamide, USP.

 

“Applicable Law” means all applicable local, state, national, regional or international statute, law, ordinance, rule, treaty, regulation, common law or other legal requirement, including provisions of all statutes (including the Federal Food, Drug and Cosmetic Act), laws, rules, regulations, administrative codes, ordinances, decrees, orders, decisions, guidance documents (including FDA guidance documents), injunctions, awards, judgments, and permits and licenses of or from governmental authorities, and the rules of any applicable securities exchange.

 

“Arbitrators” has the meaning set forth in Section 8.12(b).

 

“Assumed Liabilities” means all claims and complaints (including, without limitation, all damages, losses, expenses and liabilities) relating to the Product (regardless of whether the Product is Labelled with Taro information and NDC number or Strongbridge information and NDC number), made or brought on or after the Closing Date, including, without limitation, all liabilities arising out of: (i) the research, development, sale or use of the Product and Lifecycle Product by Strongbridge on or after the Closing; (ii) the purchase, consumption or use of the Product and Lifecycle Product by Third Parties which Product and Lifecycle Product was provided by Strongbridge to such Third Parties on or after the Closing Date; (iii) the Regulatory Approval; (iv) any payment required to be made to any Third Party on net sales of the Product and Lifecycle Product, including any payment required to be made under the Merck Agreements.

 

“Back License” has the meaning set forth in Section 2.4(b).

 

“Calendar Year” means each successive period of twelve (12) months commencing on January 1 and ending on December 31.

 

“CDA” has the meaning set forth in Section 8.7.

 

2

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

“Commercial Launch” means the date that Product, other than the Taro Product supplied at or about Closing as set forth in Section 4.1(a), is first dispensed by or on behalf of Strongbridge to a Third Party, which date shall not be earlier than April 1, 2017.

 

“Commercialization” or “Commercialize” means the ongoing process and activities generally engaged in by a pharmaceutical company marketing human pharmaceutical therapeutic products to establish and maintain a presence for such product in a given country within the Territory, including offering for sale, selling, marketing, promoting, distributing, having distributed, importing or having imported into and within the Territory, exporting and having exported within the Territory, such product.  For clarity, any activities relating to manufacturing of the human pharmaceutical therapeutic products is specifically excluded.

 

“Commercially Reasonable Efforts” with respect to any activity means the efforts and resources that would be used in the performance of the relevant activity in compliance with applicable Law by a Person (engaged in the manufacture and supply or commercialization of pharmaceutical products, as applicable) of comparable size and resources as the applicable Party with regard to a product at a similar stage in its product life taking into account the following factors to the extent reasonable and relevant: issues of safety and efficacy, product profile, market potential, competitive market conditions, duration of exclusivity or other proprietary position of the product and the potential profitability and economic return of the product, all as measured by the facts and circumstances at the time such efforts are due.  Where this Agreement requires a Party to use Commercially Reasonable Efforts, such efforts and resources that are used by such Party’s Affiliates, agents, sublicensees and licensees, as relevant, shall also be attributed to such Party.

 

“Closing” has the meaning set forth in Section 5.1(a).

 

“Closing Date” means the date on which the “Closing” occurs as defined in Section 5.1(a).

 

“Competitive Product” means (i) any pharmaceutical product Labelled and indicated for the Indication, or (ii) any pharmaceutical product containing the API.

 

“Diplomat/Envoy” means the distributor used to distribute the Product in the Territory by Taro prior to the Closing Date and by Strongbridge on or after the Closing Date.

 

“Dispute” has the meaning set forth in Section 8.12(b).

 

“DMF” means Taro’s Drug Master File number 26664.

 

“Domain Names” has the meaning set forth in Section 2.1(a).

 

“Excluded Assets” has the meaning set forth in Section 2.1(b).  “Excluded Liabilities” means all liabilities claims and complaints (including, without limitation, all damages, losses, expenses and liabilities) arising out of: (i) the research, development, manufacture, sale or use of the Product by Taro prior to the Closing Date; (ii) the purchase, consumption or use of the

 

3

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Product by Third Parties which Product was provided by Taro to such Third Parties before the Closing Date; and (iii) any Excluded Assets.

 

“Existing Patients” has the meaning set forth in Section 4.1(a).

 

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

 

“First Tranche Upfront Payment” has the meaning set forth in Section 3.1(a).

 

“Generic Product” means a pharmaceutical product that is therapeutically equivalent to the Product where “therapeutically equivalent” means, with respect to a Product, a drug product that (a) is approved under 21 U.S.C. 355(j) or 21 U.S.C. 355(b)(2) (or any respective successor law),  (b) is rated by the FDA to be therapeutically equivalent to such Product, and (c) is legally substitutable for such Product at the pharmacy under Applicable Law.

 

“IND” means the United States Investigational New Drug Application #127873.

 

“Indemnified Party” has the meaning set forth in Section 7.3.

 

“Indemnifying Party” has the meaning set forth in Section 7.3.

 

“Indication” means the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.

 

“Intellectual Property Rights” means Patents, copyrights, trade secrets, database rights, proprietary Know-How and similar rights of any type (excluding trademarks) under any common law or statute, including all applications, registrations, extensions and renewals relating to any of the foregoing.

 

“Inventory Units” has the meaning set forth in Section 4.1(a).

 

“Know-How” means all technical information and other technical subject matter, proprietary methods, ideas, concepts, formulations, discoveries, inventions, devices, prototypes, technology, trade secrets, compositions, designs, formulae, data (including clinical, non-clinical and preclinical data), know-how, show-how, specifications, drawings, techniques, results, processes, methods, procedures and/or designs, whether or not patentable, and in all cases, including any of the foregoing that are included in the DMF.

 

“Labeled” means, with respect to finished goods Product, means all labels and other written, printed, or graphic matter (i) on the Product containers or wrappers, or (ii) accompanying the Product, provided, however, Label shall not include any embossing or other markings directly on the Product tablet.

 

“Liens and Encumbrances” means, with respect to the Regulatory Approval, any mortgage, lien, pledge, charge, security interest or encumbrance of any kind.

 

4

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

“Lifecycle Product” means a pharmaceutical product containing the API that is a natural evolution or line extension of the Product and is developed by or on behalf of Strongbridge for Commercialization in the Territory.

 

“Marketing Materials” means the documents, graphics and other materials used by Taro prior to the Closing to advertise, market and promote the Product in the Territory and identified on Schedule 1(a).

 

“Merck Agreements” means (i) the Asset Purchase and Sale Agreement effective May 12, 2008 between Taro Pharmaceuticals USA Inc. and Merck & Co, Inc., and (ii) any ancillary agreement that was a part of the transaction contemplated by the Asset Purchase and Sale Agreement.

 

“Milestone Payments” has the meaning set forth in Section 3.1(c).

 

“New York Court” has the meaning set forth in Section 8.11.

 

“NDA” means collectively: (i) that certain United States New Drug Application #01-1366, including all amendments and supplements thereto, and (ii) the Orphan Designation Request #10-3142.

 

“New Product Embossing” has the meaning set forth in Section 4.8(a).

 

“Non-Blocking License” has the meaning set forth in Section 2.4(a).

 

“Party” means Taro or Strongbridge, individually, and “Parties” mean Taro and Strongbridge, collectively.

 

“Patent” and “Patents” mean all U.S. patents and patent applications, including any and all provisionals, continuations, divisionals, continuation-in-part applications, substitutions, reissues, renewals, re-examinations, supplementary protection certificates, patent term extensions, adjustments or restoration rights, registrations, confirmations, successor protective rights or subsequently issued protective rights of similar nature of any of the above.

 

“Permitted Assignee” has the meaning set forth in Section 4.4(a).

 

“Product” means the pharmaceutical product approved for Commercialization in the U.S. under the NDA and marketed under the Product Trademark in the Territory.

 

“Product Trademark” means the trademark registration specified in Schedule 1(b), and the corresponding goodwill associated with such trademark.

 

“Purchased Assets” has the meaning set forth in Section 2.1(a).

 

“Purchase Price” means, collectively, the Upfront Payment and the Milestone Payments.

 

5

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

“Regulatory Approval” means, collectively, the NDA and the IND, along with other correspondence, documentation and files directly and solely related thereto that are maintained by or on behalf, and reasonably within the control of, Taro.

 

“Reversion Conditions” has the meaning set forth in Section 4.6

 

“Reversion Rights” has the meaning set forth in Section 4.6.

 

“Second Tranche Upfront Payment” has the meaning set forth in Section 3.1(a).

 

“Sales Report” has the meaning set forth in Section 3.2.

 

“Strongbridge” has the meaning set forth in the Preamble.

 

“Strongbridge Inventory” has the meaning set forth in Section 4.1(a).

 

“Strongbridge Product” has the meaning set forth in Section 4.1(c).

 

“Supply Agreement” has the meaning set forth in the Recitals.

 

“Tablet Change” has the meaning set forth in Section 4.8.

 

“Taro” has the meaning set forth in the Preamble.

 

“Taro Inventory” has the meaning set forth in Section 4.1(a).

 

“Taro Product” means the Product that is Labeled with Taro information and NDC number, other than Taro Inventory.

 

“Taxes” means all taxes of any kind, and all charges, fees, customs, levies, duties, imposts, required deposits or other assessments, including all federal, state, local or foreign net income, capital gains, gross income, gross receipt, property, franchise, sales, use, excise, withholding, payroll, employment, social security, workers’ compensation, unemployment, occupation, capital stock, ad valorem, value added, transfer, gains, windfall profits, net worth, asset, transaction, and other taxes, and any interest, penalties or additions to tax with respect thereto, imposed upon any individual or entity by any taxing authority or other governmental authority under the laws of the applicable country in the Territory.

 

“Territory” means the United States of America, its possession and territories, including the Commonwealth of Puerto Rico.

 

“Third Party” means an entity other than Taro or Strongbridge or an Affiliate of either Party.

 

“Trademark License” has the meaning set forth in Section 2.3(a).

 

“Units of Product” means a bottle of Product or Lifecycle Product containing 100 tablets.

 

6

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

1.2                               Interpretation.

 

(a)           Whenever any provision of this Agreement uses the term “including” (or “includes”), such term shall be deemed to mean “including without limitation” and “including but not limited to” (or “includes without limitation” and “includes but is not limited to”) regardless of whether the words “without limitation” or “but not limited to” actually follow the term “including” (or “includes”);

 

(b)           All definitions set forth herein shall be deemed applicable whether the words defined are used herein in the singular or the plural;

 

(c)           Wherever used herein, any pronoun or pronouns shall be deemed to include both the singular and plural and to cover all genders;

 

(d)           The recitals set forth at the start of this Agreement, along with the Exhibits and Schedules to this Agreement, and the terms and conditions incorporated in such recital, Exhibits and Schedules shall be deemed integral parts of this Agreement and all references in this Agreement to this Agreement shall encompass such recitals, Exhibits and Schedules and the terms and conditions incorporated in such recitals, Exhibits and Schedules, provided, that in the event of any conflict between the terms and conditions of this Agreement and any terms and conditions set forth in the Exhibits and Schedules, the terms of this Agreement shall control;

 

(e)           The Agreement shall be construed as if both Parties drafted it jointly, and shall not be construed against either Party as principal drafter;

 

(f)            Unless otherwise provided, all references to Sections and Schedules in this Agreement are to Sections and Schedules of and to this Agreement;

 

(g)           Any requirements of notice or notification by one Party to another shall be construed to mean written notice in accordance with Section 8.1; and

 

(h)           Wherever used, the word “shall” and the word “will” are each understood to be imperative or mandatory in nature and are interchangeable with one another.

 

ARTICLE II — PURCHASE AND SALE

 

2.1          Purchase and Sale.

 

(a)           On and subject to the terms and conditions set out in this Agreement, Taro hereby sells, conveys, and transfers to Strongbridge, and Strongbridge hereby purchases and accepts the sale, conveyance and transfer of all of Taro’s right, title and interest in and to (i) the Regulatory Approval, (ii) the domain names set forth on Schedule 2.1(a)(ii) (the “Domain Names”) and (iii) the Marketing Materials ((i), (ii) and (iii) collectively referred to as “Purchased Assets”), in each case on the Closing Date, subject to Taro’s reversionary right to the Regulatory Approval upon the occurrence of the Reversion Conditions.

 

(b)           Except for the Purchased Assets and the license rights set forth below, no other assets, property, rights and interests of Taro and its Affiliates are being sold, conveyed or

 

7

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

transferred to Strongbridge under this Agreement, including all patents, information and know how, trademarks, trade names, good will, intellectual property and proprietary rights, new drug applications and their equivalents (collectively, “Excluded Assets”).  For clarity, the DMF is not included as part of the Regulatory Approval.  Taro hereby grants to Strongbridge a right of reference to the DMF for the purpose of maintaining the Regulatory Approval in accordance with Applicable Law and research and development, seeking regulatory approval for and Commercialization in the Territory of Lifecycle Products.

 

(c)           The Marketing Materials shall be conveyed, transferred, assigned and provided by Taro to Strongbridge “AS IS, WHERE IS, WITH ALL FAULTS” and with no express or implied representations or warranties of any kind whatsoever, including without limitation, whether such Marketing Materials comply with Applicable Law.  If Strongbridge choose to use the Marketing Materials to Commercialize Product or Lifecycle Product in the Territory on and after the Closing Date, Strongbridge shall have sole responsibility for determining whether the Marketing Materials comply with Applicable Law or whether use of the Marketing Materials infringes upon any rights of a Third Party.

 

2.2          Liabilities.  As of the Closing Date:

 

(a)           Strongbridge shall assume and pay, perform or otherwise be responsible for the Assumed Liabilities.

 

(b)           Taro shall retain and continue to be responsible for the Excluded Liabilities.

 

2.3                               Trademark License.

 

(a)           Subject to the terms and conditions contained herein, Taro, on behalf of its Affiliate, hereby grants to Strongbridge, and Strongbridge hereby accepts, a nontransferable (except as permitted pursuant to Section 4.4(a)), non-sublicensable (except as permitted below), sole and exclusive, royalty-free license to use the Product Trademark in connection with the Product and Lifecycle Product solely in the Territory (“Trademark License”).  For the avoidance of doubt, without such consent from Taro, Strongbridge may nonetheless sublicense its Trademark License to its Affiliates and distributors, but only as reasonably necessary to Commercialize the Product and Lifecycle Product on behalf of Strongbridge in the Territory.  Any attempted assignment or sublicense by Strongbridge not permitted under this Section 2.3(a) shall be void and of no force or effect and shall constitute a material breach of this Agreement.

 

(b)           Strongbridge shall use and shall cause its permitted sublicensees and Permitted Assignee to use the Product Trademark only in connection with the Product and Lifecycle Product for Commercialization by or on behalf of Strongbridge in the Territory.  Taro shall not itself use, or license or otherwise permit any Third Party to use the Product Trademark in the Territory unless the Trademark License had been terminated.

 

(c)           Strongbridge agrees to use the Product Trademark only in relation to the Product and Lifecycle Product in the Territory, consistent with Taro’s standard reasonably set by Taro, as communicated from time to time to Strongbridge with sufficient prior notice.  Strongbridge agrees not to intentionally use the Product Trademark in any way that would diminish, tarnish,

 

8

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

disparage, or damage the goodwill in and to the Product Trademark.  Strongbridge agrees to use the same level of due care to avoid diminishing, tarnishing, disparaging, or damaging the goodwill of the Product Trademark as Strongbridge would use in connection with trademark owned by Strongbridge.

 

(d)           Strongbridge shall ensure that Product Trademark (i) is used in a manner sufficient to constitute trademark usage under applicable law, (ii) is clearly identified as a trademark under applicable law (e.g., through the use of a “®”, “TM” or other appropriate identifier) and that such “Product Trademark is exclusively licensed to Strongbridge”, and (iii) are not used as combination marks with other marks or trademarks without the prior written consent of Taro.  Any and all use by Strongbridge, permitted sublicensees and Permitted Assignee of the Product Trademark and any goodwill arising therefrom shall inure to the sole benefit of Taro and its Affiliates.

 

(e)           Strongbridge may not and agrees that neither it nor any of its permitted sublicensees and Permitted Assignee will use the Product Trademark outside the Territory.

 

(f)            Strongbridge hereby expressly acknowledges Taro’s ownership of, and rights in, the Product Trademark.   Strongbridge agrees that it will not (and will not assist or authorize any Third Party to) attack, dispute or contest the validity of Taro’s ownership of the Product Trademark.

 

(g)           Taro shall prepare, file, prosecute and maintain trademark applications and registrations at the United States Patent and Trademark Office for the Product Trademark.  All costs and expenses (including but not limited to attorneys’ fees and expenses and official fees) of preparing, filing, prosecuting and maintaining the Product Trademark shall be borne by Taro.

 

2.4          License.

 

(a)           Taro hereby grants to Strongbridge an exclusive, fully paid-up, royalty-free, nontransferable (except as permitted pursuant to Section 4.4(a)), non-sublicenseable (except as permitted below) right to Commercialize the Product and to research, develop, seek regulatory approval for and Commercialize Lifecycle Products in the Territory, in each case under any Intellectual Property Rights owned or acquired by Taro or its Affiliates on or after the Closing Date, that would otherwise be violated by the Commercialization of the Product under the NDA as provided by Taro on the Closing Date by Strongbridge, its permitted sublicensee and Permitted Assignee (“Non-Blocking License”).  For the avoidance of doubt, without consent from Taro, Strongbridge may only sublicense the Non-Blocking License (i) to its Affiliates and distributors, but only as reasonably necessary to Commercialize the Product or Lifecycle Products in the Territory, and (ii) to Persons assisting in the research and development of Lifecycle Products solely by or on behalf of Strongbridge.  Any attempted assignment or sublicense by Strongbridge not expressly permitted under this Section 2.4(a) shall be void and of no force or effect and shall constitute a material breach of this Agreement.

 

(b)           Strongbridge hereby grants to Taro a non-exclusive, fully paid-up, royalty-free, transferable, sublicenseable (for multiple tiers) right to Commercialize the Product and to research, develop, seek regulatory approval for and Commercialize lifecycle Products in each

 

9

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

case outside the Territory, in each case under any Intellectual Property Rights created by or on behalf of Strongbridge or its Affiliates on or after the Closing Date that relies on the Intellectual Property Rights licensed by Taro to Strongbridge under Section 2.4(a), (“Back License”).

 

(c)           Taro hereby grants to Strongbridge an exclusive license under all copyrights in the Marketing Materials to reproduce, display, perform and create derivative works of the Marketing Materials for the sole purpose of marketing, advertising and promoting the Product and Lifecycle Products in the Territory, provided that all such use shall be subject to Section 4.7.

 

2.5          Regulatory Approval Transfer; Retained Rights.

 

(a)           On or promptly after the Closing Date, Taro shall deliver a complete copy of the Regulatory Approval to Strongbridge by shipping such items, at Strongbridge’s expense, to a destination in the United States specified by Strongbridge.

 

(b)           Taro retains the right for itself and its Affiliates to reference the clinical information and data contained in the Regulatory Approval.

 

(c)           Strongbridge acknowledges that Merck has retained certain rights under the Merck Agreements and hereby consents to the rights retained by Merck.

 

2.6          Non-Compete.

 

(a)           For so long as the Orphan Designation applies to the NDA, Taro and its Affiliates shall not, directly or indirectly (other than through Strongbridge), (i) Commercialize a Competitive Product in the Territory, (ii) promote any product in the Indication in the Territory, or (iii) undertake or have undertaken any clinical activities in the Territory with respect to a Competitive Product in the Territory for the Indication.

 

(b)           Following expiration of the Orphan Designation for the NDA until the sale of the first Generic Product, Taro and its Affiliates shall not, directly or indirectly (other than through Strongbridge), itself or by assisting any Third Party (including by sharing any Confidential Information related to the Product therewith), Commercialize a product in the Territory for the Indication or promote any product in the Indication in the Territory, provided that:

 

(i)            Taro may only Commercialize a product containing the API if such product would not reasonably be expected to have a material impact on the market for the Product (including by taking into account potential off-label prescribing of such product);

 

(ii)           In the event that the Parties disagree regarding a potential material impact on the market for the Product, the provisions of Section 8.12(a) other than the last sentence thereof shall apply to resolution of such disagreement, and if it remains unresolved thereafter, the Parties shall submit such disagreement for resolution by an independent third-party expert having at least fifteen (15) years of experience as a senior executive in the pharmaceutical industry with responsibility for marketing strategies for pharmaceutical products and reasonably acceptable to both Parties.  The Parties shall simultaneously submit their arguments in written form along with any supporting written evidence to the expert within ten (10) Business Days after the end of the

 

10

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

process set forth in Section 8.12(a) other than the last sentence thereof, for decision on such written arguments and evidence.  The expert shall render its decision within thirty (30) days of receipt of the written arguments and evidence.  The decision of the expert shall be final and binding on the Parties and the costs and expenses of such expert shall be borne by the Party against whom the expert’s decision is rendered.

 

(c)           Notwithstanding the foregoing, Strongbridge acknowledges in the event that Taro or any of its Affiliates acquires any business (or assets) which is Commercializing a Competitive Product at the time of such acquisition, Taro shall not be in violation of its obligations under this Section 2.6 if Taro or its applicable Affiliate ceases Commercializing such Competitive Product within twelve (12) months from the effective date of the closing of the acquisition.

 

(d)           In addition, if Taro or any of its Affiliates are acquired by or merged with a Third Party that is Commercializing a Competitive Product at the time of such acquisition or merger, such Third Party and its other Affiliates will not have any obligations under this Section 2.6; provided that the division, subsidiary or business group of the surviving party in such change of control that Commercializes such Competitive Product shall not have access to, and shall not refer to, rely upon or use in any manner, the Intellectual Property Rights owned by Taro or its Affiliates that are necessary for the Commercialization of the Product under the NDA provided to Strongbridge on the Closing Date with respect to such Competitive Product.

 

(e)           Following the first sale of a Generic Product in the Territory, the provisions of this Section 2.6 shall cease to apply.

 

ARTICLE III — PAYMENTS/REPORTS/AUDITS

 

3.1          Purchase Price.  In consideration of the sale, assignment, conveyance, and delivery of the Regulatory Approval and Domain Names and the grant of the Trademark License and Non-Blocking License, Strongbridge shall assume the Assumed Liabilities and make payment to Taro as follows:

 

(a)           On the Closing Date, Strongbridge shall pay to Taro a non-refundable, non-creditable payment in the amount of One Million Dollars ($1,000,000) (the “First Tranche Upfront Payment”), by wire transfer of immediately available funds to an account specified in writing by Taro prior to the Closing Date; and

 

(b)           One hundred (100) days after the Closing Date, Strongbridge shall pay to Taro a non-refundable, non-creditable payment in the amount of Seven Million Five Hundred Thousand Dollars ($7,500,000) (the “Second Tranche Upfront Payment”), by wire transfer of immediately available funds to an account specified in writing by Taro prior to the Closing Date; and

 

(c)           Strongbridge shall make milestone payments to Taro if the sales milestone event set forth below is achieved in any twelve month period with respect to the Product and Lifecycle Product in the Territory (“Milestone Payments”).  Strongbridge shall promptly notify Taro in writing of the achievement of such milestone event but in no event later than seven (7) days after Strongbridge’s determination that the Units of Product sold during such twelve month period have reached the threshold amount set for the applicable Milestone Payment.  Strongbridge shall

 

11

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

pay Taro within fifteen (15) days from the date of Strongbridge’s notification the applicable Milestone Payment.

 

	
Milestone
   Event
   Number
    	
 
    	
Milestone Event
    	
 
    	
Milestone
   Payment
    	
 
    
	
1.
    	
 
    	
Aggregate Units of Product dispensed by or on behalf of   Strongbridge in any 12-month period in the Territory equal or exceed [****]   Units of Product. Excludes the Inventory Units provided by Taro free of   charge.
    	
 
    	
$
    	
[****]
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2.
    	
 
    	
Aggregate Units dispensed by or on behalf of Strongbridge in   any 12-month period in the Territory equal or exceed [****]   Units of Product. Excludes the Inventory Units provided by Taro free of   charge.
    	
 
    	
$
    	
[****]
    	
 
    

 

Each of the milestone payments set forth above shall be due one time only.  For clarity, the Milestone Payments are cumulative, such that if Milestone Event #2 is reached before Strongbridge has made any milestone payments for the achievement of Milestone Event #1, then both milestone payments (i.e., Seven Million Five Hundred Thousand Dollars ($7,500,000) will be payable to Taro upon the achievement of Milestone #2.

 

3.2          Sales Reports.  For so long as Milestone Payments are still outstanding to Taro, Strongbridge shall furnish to Taro a written report on a monthly basis showing the Units of Product dispensed by or on behalf of Strongbridge, its Affiliates in the Territory (“Sales Report”).  Each Sales Report shall be due within ten (10) days of the end of each calendar month.

 

3.3          Audits.  Taro may request not later than two (2) years following receipt thereof, and Strongbridge shall provide to Taro, written documentation supporting the invoicing data in any Sales Report.

 

3.4                               Taxes.

 

(a)           Except as provided in Section 3.4(a), Taro shall be liable for all income and other Taxes (including interest) imposed upon any payments made by Strongbridge to Taro under this Agreement (“Agreement Payments”).  If applicable laws, rules or regulations require the withholding of Taxes, Strongbridge shall make such withholding payments and shall subtract the amount thereof from the Agreement Payments.  Strongbridge shall submit to Taro appropriate proof of payment of the withheld Taxes as well as the official receipts within a reasonable period of time.  Strongbridge shall provide Taro reasonable assistance in order to allow Taro to obtain the benefit of any present or future treaty against double taxation which may apply to the Agreement Payments.

 

12

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

(b)           Strongbridge shall bear and be responsible for and pay all applicable Taxes related to (i) the transfer to Strongbridge of the Regulatory Approval and the license rights granted under this Agreement and (ii) the promotion, marketing, sale and distribution by Strongbridge of the Product and Lifecycle Product in the Territory, and shall indemnify and hold Taro harmless from any liability relating to such Taxes other than any taxes based on net income and imposed on Taro resulting from such transfer.

 

(c)           Taro shall indemnify and hold Strongbridge fully harmless from any amounts owed to any taxing authority in respect of any payments made under this Agreement.  If Strongbridge is assessed tax in respect of the foregoing, Taro shall have the right (but not the obligation to assume the defense of Strongbridge and represent Strongbridge, at Taro’s cost, before the taxing authority.  Failure by Strongbridge to provide notice to Taro with fifteen (15) days of such tax assessment shall relieve Taro of any responsibility to indemnify Strongbridge under this Section 3.4(c) but solely to the extent of any prejudice to Taro arising from such failure.

 

3.5          Interest.  If any payment by Strongbridge under this Agreement is not made within thirty (30) days of when due, Strongbridge shall thereafter pay interest to Taro, on all such payments in an amount equal to the lesser of the prime rate reported in the Wall Street Journal (Eastern Edition) on the payment date plus one percentage point, or the maximum rate permitted by law, such interest to be accrued and payable daily without the necessity for any notice, demand or other action by Taro until the overdue amount has been paid in full.

 

3.6          Indemnity.  Each Party shall indemnify the other Party for all costs and expenses (including but not limited to attorneys’ fees) incurred in attempts) to collect any payments due or to enforce any remedy provided under this Agreement, provided that no such indemnification shall be required for any matter that was subject to a bona fide dispute by either Party.

 

ARTICLE IV — COVENANTS AND AGREEMENTS

 

4.1          Supply of Inventory Units.

 

(a)           Promptly following Closing, Taro shall deliver such quantities of Units of Product to Diplomat/Envoy such that Diplomat/Envoy shall have Four Hundred (400) Units of inventory of Taro Product free of charge to Strongbridge (“Taro Inventory”) and/or inventory of Product that is Labeled with Strongbridge information and NDC number free of charge to Strongbridge, to the extent available (“Strongbridge Inventory” and collectively with the Taro Inventory, the “Inventory Units”) on a consignment basis.  The Inventory Units shall be supplied to patients receiving the Product from Taro free of charge prior to the Closing Date (“Existing Patients”).  After the Closing, the Parties shall agree on the quantity of Taro Inventory and Strongbridge Inventory that will comprise the Inventory Units to be delivered and the delivery date.  The Parties agree that Strongbridge shall cause Diplomat/Envoy to exhaust all Taro Inventory to Existing Patients, prior to distributing any Strongbridge Inventory.  Strongbridge shall be responsible for all fees charged by Diplomat/Envoy for distribution of the Inventory Units, the cost of insurance and shipping associated with delivery of such Inventory Units to Diplomat/Envoy.  Risk of loss for the Inventory Units shall transfer to Strongbridge after the Inventory Units have been loaded onto the carrier at Seller’s facility in Cranbury Twp., NJ.  Taro

 

13

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

agrees to hold title to the Inventory Units until distributed to the Existing Patients by Diplomat/Envoy.  If there remains any Strongbridge Inventory at Diplomat/Envoy on March 31, 2017, title for the Strongbridge Inventory shall be transferred to Strongbridge at 11:59PM on March 31, 2017 and Strongbridge shall be permitted to dispense such Strongbridge Inventory for a charge on April 1, 2017.  If there remains any inventory of Taro Inventory at Diplomat/Envoy on March 31, 2017 and such Taro Inventory is not needed for meeting Strongbridge market demand pursuant to Section Section 4.1(c)(B), Strongbridge shall have such Taro Inventory destroyed at its cost and expense. For clarity, Strongbridge shall supply Inventory Units free of charge to Existing Patients through March 31, 2017.

 

(b)           Taro shall maintain and store the Inventory Units supplied to Diplomat/Envoy under Section 4.1(a) in accordance with the specification for the Product.

 

(c)           All Inventory Units must be provided to patients free of charge prior to April 1, 2017.  Strongbridge may not dispense any Product, including Inventory Units, for a charge unless and until: (i) April 1, 2017, (ii) the Products are Labeled with Strongbridge’s information, Strongbridge’s NDC number and contains the Tablet Change (defined below) (“Strongbridge Product”), provided that if Taro is unable to manufacture and ship Product that is not Taro Product in sufficient time prior to April 1, 2017 to enable the uninterrupted supply of Product to patients, then until such time as Product that is not Taro Product can be so supplied by Taro, and only to the extent of such inability to supply, (A) Strongbridge may supply, for a charge to patients, any Strongbridge Inventory remaining at Diplomat, (B) if available from Taro, Taro shall supply under the Supply Agreement and Strongbridge shall be permitted to transfer to patients for a charge Product that bears the Taro name on the tablet but is otherwise Labeled with Strongbridge’s information and NDC number, or (C) if the Product packaged as described  in the foregoing (B) is not available, then Taro shall supply sufficient quantities of Taro Product to Strongbridge under the Supply Agreement to enable Strongbridge to meet market demand until Strongbridge Product can be supplied by Taro.  The Taro Product supplied pursuant to this Section 4.1(c)(B) may be transferred to patients for a charge by Strongbridge.

 

4.2          Transition for Existing Patients.

 

(a)           Promptly following the Closing Date, Strongbridge agrees to establish a patient assistance program for the Product.  Strongbridge shall be responsible for all costs associated with such program, and for ensuring that such program complies with applicable law.

 

(b)           Between the Closing Date and Commercial Launch of the Product, Strongbridge shall ensure that all Existing Patients with insurance to cover the Product are transitioned for coverage of the Product to Existing Patients’ insurance and Existing Patients without insurance coverage are transitioned for coverage of the Product to the Patient Assistance Program established by Strongbridge.

 

(c)           For a period of two (2) years following Commercial Launch, to the extent that there are any Existing Patients that do not have insurance to cover the Product and do not qualify for any Patient Assistance Programs, Strongbridge agrees that will continue to provide such Existing Patients with Products free of charge which Product shall be under the Strongbridge Label and NDC number.

 

14

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

4.3          Marketing Commitment.

 

(a)           After the Closing, Strongbridge shall use Commercially Reasonable Efforts to Commercialize the Product in the Territory.  Notwithstanding the immediately preceding sentence, Strongbridge agrees to the marketing commitment set forth on Schedule 4.3.  Commencing on January 15, 2018 and on each anniversary thereafter through January 15, 2023, Strongbridge will provide reasonable documentation demonstrating its compliance under Schedule 4.3.

 

(b)           Strongbridge shall provide Taro, no later than thirty (30) days prior to April 1 of each calendar year during the Term, a marketing and sales plan, including forecasts and sales for the Product in the Territory.

 

4.4                               Non-Assignability.

 

(a)           For a period of two years after the Commercial Launch, Strongbridge may not transfer or assign its rights to the Regulatory Approval without the prior written consent of Taro, provided that Strongbridge may assign its right to the Regulatory Approval to an Affiliate or an acquirer of or all or substantially all of its assets or business (whether by merger, consolidation, stock purchase or otherwise), without the prior written consent of Taro (a “Permitted Assignee”) but with prior notice to Taro.  Permitted Assignee shall agree in writing that it agrees to assume all of Strongbridge’s obligations under this Agreement.

 

(b)           For a period of two years after the Commercial Launch, Strongbridge may not transfer or assign its rights to the Trademark License and the Non-Blocking License without the prior written consent of Taro, provided that Strongbridge may assign its rights to the Trademark License and the Non-Blocking License to an Affiliate or an acquirer of or all or substantially all of its assets or business (whether by merger, consolidation, stock purchase or otherwise), without the prior written consent of Taro.

 

(c)           Following expiration of the two-year period in the foregoing (a) and (b), Strongbridge may transfer or assign its rights to the Regulatory Approval together with the Trademark License and Non-Blocking license without the prior written consent of Taro to an acquirer of all of Strongbridge’s right title and interest hereunder, provided that such acquirer agrees in writing to assume all of Strongbridge’s obligations hereunder.

 

4.5          Minimum Purchase Quantities.  Strongbridge shall purchase the minimum Units of Products as agreed between the Parties under the Supply Agreement.

 

4.6          Reversion Conditions.  Strongbridge’s obligations under Sections 4.1, 4.2, 4.3, 4.4 and 4.5 are collectively referred to as the “Reversion Conditions”.  Any material non-compliance with any Reversion Condition shall be deemed a material breach of Strongbridge’s obligation under this Agreement.  In the event that Taro notifies Strongbridge in writing that Strongbridge is in material breach of a Reversion Condition and Strongbridge does not cure such breach within ninety (90) days following such notice or such breach cannot be cured, then, after such ninety-day period, Taro may elect to have the Purchased Assets returned to Taro and to terminate the Trademark License and the Non-Blocking License (“Reversion Right”).  In such event,

 

15

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Strongbridge shall cooperate with Taro and take, or cause to be taken, all actions, or to do, or cause to be done, all reasonable things necessary to return the Purchased Assets to Taro and termination of the license rights granted hereunder.

 

4.7          Use of Names.  Subject to Section 4.1(c) and except as Required by Applicable Law:, (a) Taro will mark clearly all Product and Lifecycle Product manufactured or distributed following Commercial Launch to indicate Strongbridge’s ownership of the Product and Lifecycle Product and (b) Strongbridge, except for the Taro Product, will not use the trade name  Taro in connection with the Product or Lifecycle Product and shall not otherwise  use the tradename of Taro, including as part of the name of Strongbridge or any Affiliate of the Strongbridge.  Subject to the immediately preceding sentence, after the Closing Date, Strongbridge shall not give the impression to the public, to physicians or the pharmaceutical marketplace that the Product or Lifecycle Product is a product of Taro or in any way connected to Taro except as specifically agreed to by Taro under this Agreement with respect to the Product Trademark.

 

4.8          Removal of Taro Name from Tablet.  Promptly following the Closing,

 

(a)           The Parties shall confer and decide on a new embossing design for the Product tablets that is reasonably acceptable to both Parties and does not include the Taro name (the “New Product Embossing”);

 

(b)           Taro shall provide to Strongbridge a plan for the changeover in the manufacturing of the Product to produce Product having the New Product Embossing;

 

(c)           Promptly thereafter Strongbridge shall file changes to the NDA with the FDA for notification of the New Product embossing as required by the FDA to enable dispensing of the Product therewith; and

 

(d)           The Parties shall reasonably cooperate to implement Taro’s changeover plan.

 

(the foregoing process in this Section 4.8, the “Tablet Change”).

 

4.9          Patient Data.  Strongbridge shall comply with all applicable laws, rules and regulations, as amended from time to time, with respect to the use and disclosure of individually identifiable health information contained in the Regulatory Approval, and ensure that: (a) such information is used and/or disclosed only in accordance with applicable law or regulation; and (b) all appropriate technical and organizational measures are taken to protect such information against accidental, unauthorized or unlawful destruction, loss, alteration, access or disclosure.

 

4.10        Development by Taro.  To the extent that Taro undertakes any clinical trials for the further development of the Product outside the Territory, Taro shall keep Strongbridge reasonably informed with respect to such activities by providing to Strongbridge a draft copy of any such clinical trial protocol at least sixty (60) days prior to the date anticipated for its submission to a regulatory authority to permit Strongbridge to provide comments which comments Taro shall consider in good faith.

 

16

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

4.11        Provision of Information.  In the event that Strongbridge receives any inquiries or requests from any regulatory authority outside the Territory to provide Product for compassionate use or otherwise, Strongbridge shall promptly provide such information to Taro at:  Taro customer service 1-888-827-6872 (TAR-OUSA).  .  Strongbridge hereby authorizes Taro to ship Product to such regulatory authority directly from the facility where the Product is manufactured, at Taro’s costs and expense.

 

4.12        Government Reporting and Payment.

 

(a)           Strongbridge shall be responsible for payment of all rebates, chargebacks and any other similar payments for all Product dispensed after the Closing Date, regardless of whether the Product is Labelled with Taro information and NDC number or Strongbridge information and NDC number.

 

(b)           Taro shall be responsible for all governmental reporting and processing of all rebates, chargebacks and the processing of any other similar payments for all Product dispensed in the Territory Labeled with Taro information and Taro NDC number.  Strongbridge shall provide all necessary information to Taro with respect to Product dispensed in the Territory with Taro information and Taro NDC number after the Closing Date so that Taro may comply with such reporting obligation.  Strongbridge shall reimburse Taro for any payment made by Taro for rebates, chargebacks and any other similar payments with respect to such Product.

 

(c)           Strongbridge shall be responsible for all governmental reporting and processing of all rebates, chargebacks and any processing of other similar payments for all Product dispensed in the Territory Labeled with Strongbridge information and Strongbridge NDC number.

 

(d)           Strongbridge shall be responsible for responding to all complaints (in accordance with the Quality Agreement and/or Pharmacovigiliance Agreement) and processing and payment of returns for Product dispensed after the Closing Date, regardless of whether the Product is Labelled with Taro information and NDC number or Strongbridge information and NDC number.

 

ARTICLE V — EXECUTION, CLOSING AND EFFECTIVENESS

 

5.1                               Execution; Closing.

 

(a)           The transactions contemplated by this Agreement shall be consummated at a closing (the “Closing”) to occur by electronic transmission of signature pages on such date as may be mutually agreed by Strongbridge and Taro (the “Closing Date”).  The Closing shall be deemed to occur at 12:01 a.m. ET on the Closing Date.

 

(b)           Taro and Strongbridge will file or cause to be filed with the FDA, as soon as practicable after the Closing Date, the notices (substantially in the form of Schedule 5.1(b) attached hereto), required to be filed by it in connection with its transfer of the NDA and acceptance of the NDA, IND and Orphan Designation.

 

17

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

5.2          Further Assurances.  Taro and Strongbridge agree that at any time or from time to time after the Closing, each Party, at the request and expense of the other, shall execute and deliver to the other all such instruments and documents or further assurances as the other Party may reasonably request in order to transfer to Strongbridge all of Taro’s right, title and interest in and to the Regulatory Approval and the grant of the Trademark License and Non-Blocking License, as contemplated hereby; provided, however, that after the Closing, apart from such customary further assurances, the Taro and Strongbridge shall have no other obligations except as specifically set forth and described herein.

 

5.3          Broker Fees.  Each Party agrees that should any claim be made against the other Party for any broker’s commission or finder’s fee by reason of the acts of such Party, the Party upon whose acts such claim is adjudicated shall hold the other Party harmless from and against all liability and expense in connection therewith.

 

ARTICLE VI — REPRESENTATIONS AND WARRANTIES

 

6.1          Taro’s Representations and Warranties.  Taro represents and warrants to Strongbridge as of the Closing Date that:

 

(a)           Corporate Existence; Authorization; Non-contravention.

 

(i)            Taro is a corporation duly organized, validly existing and in good standing under the laws of the Cayman Islands.

 

(ii)           The execution, delivery and performance by Taro of this Agreement and each of the documents contemplated hereby to which the Taro is a party are within Taro’s corporate power, have been duly authorized by all necessary corporate action and do not contravene or constitute a default under any of the constitutive documents of Taro or of applicable law or regulation or of any agreement, judgment, injunction, order, decree or other instrument binding upon Taro or to which the Regulatory Approval or Product Trademark is subject.  This Agreement and each of the documents contemplated hereby to which the Taro is a party is a legal, valid and binding agreement of Taro enforceable against Taro in accordance with its terms.

 

(iii)          Except for the requirement that both Strongbridge and Taro provide written notice to the FDA, in the forms attached hereto as Schedule 5.1(b) of the transfer of the NDA from Taro to Strongbridge, the execution, delivery and performance by Taro of this Agreement, and the consummation by Taro of the transactions contemplated hereby, require no action by or in respect of, or filing with, any governmental body, agency or official or any other consent of any person, firm or other entity.

 

(b)           Product Rights, the NDA and License Grants.

 

(i)            The NDA has been approved by the FDA with respect to the marketing of the Product in the United States, and as of the Closing Date, remains in full force and effect.  Taro is the applicant of the NDA.  Taro owns all right, title and interest in and to the NDA and

 

18

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

the NDA is free and clear of all Liens and Encumbrances.  Taro has the right to transfer the NDA to Strongbridge in accordance with the terms of this Agreement.

 

(ii)           Taro has provided Strongbridge with a complete copy of the Regulatory Approval or will do so promptly after Closing.

 

(iii)          Taro has the right to grant to Strongbridge the rights granted under the Trademark License, and Taro has not granted prior to the Closing Date any options or licenses with respect to the Product Trademark that are inconsistent with the grants Taro has made to Strongbridge in this Agreement.

 

(iv)          To Taro’s knowledge, Taro and its Affiliates and licensees have maintained, and retained the NDA and related documentation that is required to be maintained or retained pursuant to and in accordance with Applicable Law in the Territory.

 

(c)           Litigation.  There are no pending, and to Taro’s knowledge upon reasonable investigation, threatened, private or governmental proceedings, claims, or actions in the Territory against the Taro involving the NDA, the Product or the Product Trademark.

 

(d)           Merck Agreements.  To Taro’s knowledge, Taro has not committed any breach of, and no counterparty has committed any breach of, any Merck Agreement.

 

(e)           No Consents.  Neither the execution, delivery nor performance by Taro of this Agreement and the Supply Agreement, nor the consummation by Taro of the transactions contemplated hereby or thereby, will require Taro to (i) obtain any consent or authorization of, or (ii) give any notice to, or make any filing or registration with, any Person.

 

(f)            Disclosure.  No representation or warranty by Taro in this Agreement contains any untrue statement of material fact.

 

6.2          Strongbridge’s Representations and Warranties.  Strongbridge represents and warrants as of the Execution Date and the Closing Date that:

 

(a)           Corporate Existence; Authorization; Non-contravention.

 

(i)            Strongbridge is a corporation duly organized and validly existing under the laws of Ireland.

 

(ii)           The execution, delivery and performance by Strongbridge of this Agreement and each of the documents contemplated hereby to which the Strongbridge is a party are within Strongbridge’s corporate power, have been duly approved and authorized by all necessary corporate action and do not contravene or constitute a default under the constitutive documents of Strongbridge or of applicable law or regulation or of any agreement, judgment, injunction, order, decree or other instrument binding upon Strongbridge.  This Agreement is a legal, valid and binding agreement of Strongbridge enforceable against Strongbridge in accordance with its terms.

 

19

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

(iii)          Except for the requirement that both Strongbridge and Taro provide written notice to the FDA, in the forms attached hereto as Schedule 5.1(b) of the transfer of the NDA from Taro to Strongbridge, the execution, delivery and performance by Strongbridge of this Agreement, and the consummation by Strongbridge of the transactions contemplated hereby, require no action by or in respect of, or filing with, any governmental body, agency or official or any other consent of any person, firm or other entity.

 

(b)           Disclosure.  No representation or warranty by Strongbridge in this Agreement contains any untrue statement of material fact.

 

6.3          Disclaimer of Other Warranties.  EXCEPT FOR THE EXPRESS WARRANTIES AND REPRESENTATIONS AND COVENANTS CONTAINED IN THIS AGREEMENT, OR THE EXHIBITS AND SCHEDULES ATTACHED HERETO OR THERETO, NEITHER TARO NOR STRONGBRIDGE MAKES, AND EACH HEREBY EXPRESSLY DISCLAIMS, ANY WARRANTIES OR REPRESENTATIONS, EITHER EXPRESS OR IMPLIED, WHETHER IN FACT OR IN LAW, INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.

 

ARTICLE VII— INDEMNIFICATION

 

7.1          Indemnification by Taro.  Taro shall indemnify and defend Strongbridge, its Affiliates, and their respective officers, directors and employees, against any and all damage, loss, liability and expense (including, without limitation, reasonable attorneys’ fees in connection with any action, claim, suit or proceeding brought by third parties) and the cost of remedial action under applicable laws and regulations (collectively “Claims”) arising out of: (a) any Excluded Liabilities, (b) any misrepresentation or breach of covenant, agreement, representation or warranty of Taro contained in this Agreement (collectively, the “Taro Rep Claim”), and (c) any and all acts and omissions of Taro and its Affiliates, sublicensees or assignees, and their respective officers, directors, employees and agents after the Closing Date, whether or not such acts are negligent, unlawful or otherwise wrongful in any manner, in connection with Taro’s or its assignees’ or sublicensees’ Commercialization of the Product outside the Territory, provided, however, that Strongbridge shall not be entitled to any indemnification for any Taro Rep Claim unless and until the amount of claims for which Strongbridge is entitled to be indemnified exceeds in the aggregate $75,000.  Except with respect to the representations and warranties set forth in Sections 6.1(b)(i) and 6.1(b)(iii) (for which Taro’s indemnification obligations shall extend indefinitely), the indemnification obligation for any Taro Rep Claim shall expire on the first anniversary of the Closing Date.

 

7.2          Indemnification by Strongbridge.  Strongbridge shall indemnify and defend Taro and its Affiliates, and their respective officers, directors and employees, against any Claims arising out of: (a) any and all acts and omissions of Strongbridge and its Affiliates and their respective officers, directors, employees and agents after the Closing Date, whether or not such acts are negligent, unlawful or otherwise wrongful in any manner, in connection with Strongbridge’s or its Permitted Assignee’s and permitted sublicensees’ Commercialization of the Product or a Lifecycle Product, (b) use of the Marketing Materials by Strongbridge, its Permitted Assignee and permitted sublicensees, (c) Assumed Liabilities, and (d) any misrepresentation or breach of

 

20

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

covenant, agreement, representation or warranty of Strongbridge contained in this Agreement (collectively, the “Strongbridge Rep Claim”), provided, however, that Taro shall not be entitled to any indemnification for any Strongbridge Rep Claim unless and until the amount of claims for which Taro is entitled to be indemnified exceeds in the aggregate $75,000.  The indemnification obligation for any Strongbridge Rep Claim shall expire on the first anniversary of the Closing Date.

 

7.3          Indemnification; Notice and Settlements.  A Party seeking indemnification pursuant to Section 7.1 or 7.2 (an “Indemnified Party”) shall give prompt notice to the Party from whom such indemnification is sought (the “Indemnifying Party”) of the assertion of any claim, or the commencement of any action or proceeding, in respect of which indemnity may be sought hereunder.  The Indemnifying Party shall have the right to, and shall at the request of the Indemnified Party, assume the defense, with counsel reasonably satisfactory to the Indemnified Party, of any such suit, action or proceeding at its own expense; provided that the Indemnifying Party shall not have the right to assume control of such defense and shall pay the fees and expenses of counsel retained by the Indemnified Party, if the claim which the Indemnifying Party seeks to assume control (i) seeks non-monetary relief (except where non-monetary relief is merely incidental to a primary claim or claims for monetary damages), (ii) constitutes criminal allegations against the Indemnified Party, (iii) is one in which the Indemnifying Party is also a party and joint representation would be inappropriate or there may be legal defenses available to the Indemnified Party which are different from or additional to those available to the Indemnifying Party, or (iv) involves a claim which, upon petition by the Indemnified Party, the appropriate court rules that the Indemnifying Party failed or is failing to vigorously prosecute or defend.  If the Indemnifying Party assumes the defense of such Third Party Claim, the Indemnified Party shall have the right to employ separate counsel and to participate in the defense thereof, but the fees and expenses of such counsel shall be at the expense of the Indemnified Party unless the employment thereof has been specifically authorized by the Indemnifying Party in writing.  If the Indemnifying Party shall control the defense of any claim, the Indemnifying Party shall obtain the prior written consent of the Indemnified Party (which shall not be unreasonably withheld) before entering into any settlement of a claim or ceasing to defend such claim, if pursuant to or as a result of such settlement or cessation, injunction, or other equitable relief will be imposed against the Indemnified Party, if such settlement or cessation does not expressly unconditionally release the Indemnified Party from all liabilities and obligations with respect to such claim, or if such settlement or cessation requires a payment by the Indemnified Party.  In addition, an Indemnifying Party shall not be liable under Section 7.1 or 7.2 for any settlement effected without its consent of any claim, litigation or proceeding in respect of which indemnity may be sought hereunder, which consent shall not be unreasonably withheld.]

 

ARTICLE VIII — MISCELLANEOUS

 

8.1          Notices.  Notices required or permitted under this Agreement shall be in writing and sent by prepaid registered or certified air mail or by overnight express mail (e.g., FedEx), or by electronic mail confirmed by electronic mail (including an electronic “read receipt” notice), or by tele-facsimile confirmed by a written act of the receiving Party (e.g., a telefacsimile from the receiving Party submitting its receipt of such notice) and shall be deemed to have been properly

 

21

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

served to the addressee (A) upon delivery in the case of prepaid registered or certified air mail or by overnight express mail, or (B) upon receipt of written confirmation in the case of electronic mail or telefacsimile, to the following addresses of the Parties or such other address(es) as such Party may hereafter specify by written notice to the other Party in accordance herewith:

 

If to Strongbridge:

 

Strongbridge Biopharma plc (registered office)

Arthur Cox Building

Earlsfort Terrace

Dublin 2, Ireland

 

With a copy to:

 

Strongbridge Biopharma plc (registered office)

900 Northbrook Drive

Suite 200

Trevose, Pennsylvania 19053

 

If to Taro:

 

Taro Pharmaceuticals North America, Inc.

Harbour Place

103 South Church Street

Grand Cayman KY1-1202

Cayman Islands

Attention:  General Manager

 

With a copy to:

 

Taro Pharmaceuticals USA, Inc.

3 Skyline Drive

Hawthorne, NY 10532

Attention:  General Counsel

 

8.2          Expenses.  All legal and other costs and expenses incurred in connection herewith and the transactions contemplated hereby, whether or not the transactions contemplated are consummated, shall (except as otherwise provided herein) be paid by the Party incurring such expenses; provided that all transfer taxes in connection with the purchase of the Regulatory Approval and the grant of the Trademark License and Non-Blocking License shall be borne by Strongbridge.

 

8.3          Termination; Survival.

 

(a)           This Agreement shall terminate upon: (i) the termination of the Supply Agreement or (ii) Taro’s exercise of its Reversion Right in accordance with Section 4.6.  In either case, if Strongbridge is not continuing to Commercialize the Product or Lifecycle Product

 

22

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

after the termination date, Strongbridge shall promptly assign and transfer the Purchased Assets back to Taro; the Trademark License and Product Trademark shall terminate; and Strongbridge, its Permitted Assignee and permitted sublicensees shall immediately cease all Commercialization of the Product and Lifecycle Product in the Territory.  If Strongbridge is continuing to Commercialize the Product after termination, Sections 2.3, 2.4, 3.1(c), 4.7 shall survive.

 

(b)           Sections 3.4, 7.1, 7.2, and 7.3 shall survive termination of this Agreement.

 

8.4          Section 365(n) of the Bankruptcy Code.  All rights and licenses granted under or pursuant to this Agreement by Taro to Strongbridge are, for all purposes of 11 U.S.C. Section 365(n), licenses of rights to intellectual property as defined in Title 11.  Strongbridge may elect to retain and may fully exercise all of its rights and elections under 11 U.S.C. Section 365(n).

 

8.5          Bulk Sales Statutes.  Strongbridge hereby waives compliance by Taro with any applicable bulk sales statutes in any jurisdiction in connection with the transactions under this Agreement.

 

8.6          Successors and Assigns.  Except as provided in Section 4.4, this Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the consent of the other Party; provided, however, that (a) Taro may, without such consent, assign this Agreement and its rights and obligations hereunder to an Affiliate or in connection with the transfer or sale of all or substantially all of its assets related to the subject matter of this Agreement, or in the event of its merger or consolidation or change in control or similar transaction.  Any attempted assignment not in accordance with this Sections 4.4 and 8.6 shall be void.  Any Permitted Assignee shall assume all assigned obligations of its assignor under this Agreement.

 

8.7          Entire Agreement; Amendment.

 

(a)           Taro and Strongbridge are parties to that certain Confidentiality Agreement (“CDA”) dated July 13, 2016, the terms of which are hereby incorporated into this Agreement and made an integral part hereof.  This Agreement, including, without limitation, the CDA and the Schedules hereto, embodies the entire agreement of the Parties with respect to the sale of Regulatory Approval and Domain Names and the grant of rights of the Trademark License and the Non-Blocking License and supersedes any and all prior agreements with respect thereto.

 

(b)           No waiver, amendment or modification of any provision hereof or of any right or remedy hereunder shall be effective unless in writing and signed by an authorized representative of the Party against whom such waiver, amendment or modification is sought to be enforced.

 

8.8          Public Announcement.  Subject to Section 8.9, the Seller and Buyer shall agree on the content of any press release(s), public announcement(s) or other information publicly released by the Parties relating to this Agreement and the Supply Agreement.

 

8.9          Filing Requirements.  If the execution of or the activities or obligations under this Agreement were to trigger or otherwise instigate a reporting, filing or other disclosure obligation on a Party (or any of its Affiliates) pursuant to Applicable Law, such Party shall notify the other

 

23

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Party as promptly as practicable of such obligation, and provide whatever reasonable opportunity may be available for the other Party to comment on a draft version of any such disclosure. Subject to the foregoing sentence, such Party shall have the right to make any such filing or obligated disclosure.

 

8.10        Compliance with Applicable Law.  Nothing in this Agreement shall be construed as preventing or in any way inhibiting either Party from complying with Applicable Law governing activities and obligations undertaken pursuant to this Agreement, in any manner which it reasonably deems appropriate, including, for example, by disclosing to Regulatory Authorities confidential or other information received from the other Party, subject to limitations on disclosures required by Applicable Law under the terms of the CDA.

 

8.11        Governing Law; Jurisdiction.  This Agreement shall be governed by and construed in accordance with the laws of the State of New York, United States without regard to its conflicts of laws principles.  The Parties consent to the exclusive jurisdiction of the Federal courts and the State courts of the State of New York, in each case, located in the borough of Manhattan, City of New York (the “New York Courts”) for any action in aid of arbitration, for provisional relief of the status quo or to prevent irreparable harm prior to the appointment of the Arbitrators in Section 8.12(b), and to the non-exclusive jurisdiction of the New York Courts for any action to enter or enforce any arbitral award entered in connection with this Agreement.  THE PARTIES HEREBY IRREVOCABLY WAIVE, AND AGREE TO CAUSE THEIR RESPECTIVE AFFILIATES TO WAIVE, THE RIGHT TO TRIAL BY JURY IN SUCH ACTIONS.

 

8.12        Dispute Resolution.  In the event the Parties have a dispute under the terms of this Agreement or any agreement ancillary to this Agreement, the Parties will follow the following procedure, subject to the rights of either Party to pursue equitable remedies:

 

(a)           The Parties will attempt in good faith to resolve any dispute arising out of or relating to this Agreement promptly by negotiation between a representative appointed by Taro, and for Strongbridge, the President and CEO of Strongbridge Biopharmaceuticals plc or his/her designee.  Any person may give the other Party written notice of any dispute not resolved in the normal course of business.  Within fifteen (15) days after delivery of the notice, the receiving Party will submit to the other a written response.  The notice and response will include (i) a statement of that Party’s position and summary of arguments supporting that position, and (ii) the name and title of the executive who will represent that Party and of any other person who will accompany the executive.  After delivery of the initial notice, the executives of both Parties will meet at a mutually acceptable time and place, and thereafter as often as they reasonably deem necessary, to attempt to resolve the dispute.  All reasonable requests for information made by one Party to the other will be honored.  All negotiations pursuant to this clause are confidential and will be treated as compromise and settlement negotiations for purposes of applicable rules of evidence.  In the event the negotiation between the executives is not successful in resolving the dispute within thirty (30) days after the delivery of the initial notice, the dispute will be referred to arbitration as described below.

 

(b)           Except as expressly otherwise provided in this Agreement, in the event of any dispute arising out of or relating to the interpretation of any provisions of this Agreement or the failure of either Party to perform or comply with any obligation of such Party pursuant to this

 

24

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Agreement or the breach, termination or validity hereof (a “Dispute”), such Dispute shall be finally settled by arbitration in accordance with the commercial arbitration rules of the American Arbitration Association (“AAA”), then in force and the Federal Arbitration Act, 9 U.S.C. § 1 et seq., by three (3) arbitrators (the “Arbitrators”) appointed in accordance with said rules, provided that the appointed arbitrators shall have appropriate experience in the pharmaceutical industry.  The place of arbitration shall be New York, New York, and the Arbitrators shall decide the dispute in accordance with the substantive law of the State of New York.  The Arbitrators, by accepting their appointment, undertake to conduct the process such that the award shall be rendered within six (6) months of their appointment and shall be final and binding upon all parties participating in such arbitration.  The judgment rendered by the Arbitrators may, at the arbitrator’s discretion, include costs of arbitration, reasonable attorneys’ fees and reasonable costs for any expert and other witnesses.  Judgment upon the award may be entered in any court having jurisdiction, or application may be made to such court for judicial acceptance of the award and/or an order of enforcement as the case may be.  Notwithstanding the foregoing, any Disputes regarding the scope, validity, enforceability or inventorship of any patents or patent applications shall be submitted for final resolution by a court of competent jurisdiction.  Any period of limitations or Survival Period that would otherwise expire between the initiation of the procedures described in this Section 8.12(b) and the conclusion of such procedures shall be extended until twenty (20) days following the conclusion of such procedures.  This Section 8.12(b) shall not prohibit a Party from seeking preliminary injunctive relief in aid of arbitration from a court of competent jurisdiction.

 

8.13        Language.  This Agreement, and any amendments or modifications thereto, shall be executed in the English language.  No translation, if any, of this Agreement into any other language shall be of any force or effect in the interpretation of this Agreement or in determination of the intent of either of the Parties hereto.

 

8.14        Article Headings.  The Article headings are placed herein merely as a matter of convenience and shall not affect the construction or interpretation of any of the provisions of this Agreement.

 

8.15        Further Assurances.  Each Party hereto agrees to execute, acknowledge and deliver such further instruments and do all such further acts as may be necessary or appropriate to carry out the purposes and intent of this Agreement.

 

8.16        Waiver.  The waiver by either Party of a breach or a default of any provision of this Agreement by the other Party shall not be construed as a waiver of any succeeding breach of the same or any other provision, nor shall any delay or omission on the part of either Party to exercise or avail itself of any right, power or privilege that it has or may have hereunder operate as a waiver of any right, power or privilege by such Party.

 

8.17        Modification.  No waiver, alteration or modification of any of the provisions hereof shall be binding unless made in writing and signed by the Parties by their respective officers thereunto duly authorized.

 

8.18        Severability.  If any part of this Agreement is declared invalid by any legally governing authority having jurisdiction over either Party, then such declaration shall not affect the

 

25

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

remainder of the Agreement and the Parties shall revise the invalidated part in a manner that will render such provision valid without impairing the Parties’ original intent.

 

8.19        Counterparts.  This Agreement may be executed in any number of counterparts, each of which shall be deemed to be an original, but all of which together shall constitute but one and the same instrument.

 

8.20        No Third Party Beneficiaries.  None of the provisions of this Agreement shall be for the benefit of or enforceable by any Third Party.

 

26

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

IN WITNESS WHEREOF, the Parties hereto have caused this Asset Purchase Agreement to be executed as of the Closing Date by their duly authorized representatives.

 

	
 
    	
TARO PHARMACEUTICALS NORTH   AMERICA, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/ Paul Woodhouse
    
	
 
    	
 
    	
 
    
	
 
    	
Name:
    	
Paul Woodhouse
    
	
 
    	
 
    	
 
    
	
 
    	
Title:
    	
Vice President, General   Manager
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
STRONGBRIDGE BIOPHARMA PLC
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/ Matthew Pauls
    
	
 
    	
 
    	
 
    
	
 
    	
Name:
    	
Matthew Pauls
    
	
 
    	
 
    	
 
    
	
 
    	
Title:
    	
President and CEO
    

 

27

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

Schedule 1(a)

 

MARKETING MATERIALS

 

Taro Project List

 

	
Job #
    	
 
    	
Name
    
	
2015
    	
 
    	
 
    
	
TRO-N15-002
    	
 
    	
Clinical Digital Landscape
    
	
TRO-N15-004
    	
 
    	
Keveyis Positioning
    
	
TRO-N15-005
    	
 
    	
Keveyis Logo & Branding
    
	
TRO-N15-006
    	
 
    	
Keveyis Support Services Logo & Branding
    
	
TRO-N15-008
    	
 
    	
Keveyis Day 1 Messages
    
	
TRO-N15-009
    	
 
    	
Support Services Messages
    
	
TRO-N15-010
    	
 
    	
Disease Branding
    
	
TRO-N15-013
    	
 
    	
Disease Messaging
    
	
TRO-N15-014
    	
 
    	
Day 1 Website
    
	
TRO-N15-015
    	
 
    	
Day 1 Support Services Brochure
    
	
TRO-N15-016
    	
 
    	
Day 1 HCP Product Sell Sheet
    
	
TRO-N15-017
    	
 
    	
Now Available HCP Email
    
	
TRO-N15-018
    	
 
    	
Now Available Patient Email
    
	
TRO-N15-024
    	
 
    	
Day 1 Support Services Enrollment Form
    
	
TRO-N15-026
    	
 
    	
Keveyis PPT Template
    
	
TRO-N15-028
    	
 
    	
Keveyis Now Available Site
    
	
TRO-N15-029
    	
 
    	
AANEM Conference
    
	
TRO-N15-030
    	
 
    	
PP Infographic
    
	
TRO-N15-032
    	
 
    	
HCP Swipey iPad Sell Sheet
    
	
TRO-N15-033
    	
 
    	
Patient Letters
    
	
TRO-N15-034
    	
 
    	
Keveyis Patient Stories
    
	
TRO-N15-035
    	
 
    	
AANEM Conference Email
    
	
TRO-N15-036
    	
 
    	
Tawil Reprint
    

 

28

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

	
Job #
    	
 
    	
Name
    
	
TRO-N15-038
    	
 
    	
Keveyis PAP Application Form
    
	
TRO-N15-039
    	
 
    	
Patient K2C Communications
    
	
TRO-N15-040
    	
 
    	
Disease Positioning
    
	
TRO-N15-041
    	
 
    	
Taro SEM
    
	
TRO-N15-042
    	
 
    	
AANEM Infographic
    
	
TRO-N15-043
    	
 
    	
PPA Conference Tabletop Display
    
	
TRO-N15-044
    	
 
    	
PPA Conference Keveyis FAQ Sheet
    
	
TRO-N15-045
    	
 
    	
Keveyis Creative Concept
    
	
TRO-N15-046
    	
 
    	
Brand Planning
    
	
TRO-N15-047
    	
 
    	
Taro Disease Website
    
	
TRO-N15-048
    	
 
    	
Keveyis Patient Email #3
    
	
TRO-N15-049
    	
 
    	
Keveyis HCP Email #3
    
	
TRO-N15-051
    	
 
    	
Keveyis Quick Hit Sales Aid
    
	
TRO-N15-053
    	
 
    	
Taro Rep Buisness Card Holder Leave Behind
    
	
TRO-N15-054
    	
 
    	
Digital Detail Aid
    
	
2016
    	
 
    	
 
    
	
TRO-N16-003
    	
 
    	
AAN Conference Booth
    
	
TRO-N16-005
    	
 
    	
Taro RM Campaign
    
	
TRO-N16-006
    	
 
    	
Periodic Paralysis Patient Disease Concept
    
	
TRO-N16-007
    	
 
    	
Periodic Paralysis Champions Campaign
    
	
TRO-N16-008
    	
 
    	
Doctor Discussion Guide
    
	
TRO-N16-010
    	
 
    	
Disease Booth Handout
    
	
TRO-N16-012
    	
 
    	
Driver Strategy
    
	
TRO-N16-013
    	
 
    	
AAN Pre & Post Show Emails
    
	
TRO-N16-014
    	
 
    	
Keveyis.com 1.5 Planning
    
	
TRO-N16-015
    	
 
    	
Keveyis RX PAF Insert
    
	
TRO-N16-016
    	
 
    	
Unbranded Patient Emails
    
	
TRO-N16-017
    	
 
    	
Patient Product Brochure
    
	
TRO-N16-018
    	
 
    	
PP Disease UX Expansion
    

 

29

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

Schedule 1(b)

 

PRODUCT TRADEMARK

 

	
Country
    	
 
    	
Name
    	
 
    	
Status
    	
 
    	
Application
   Number
    	
 
    	
Filing Date
    	
 
    	
Registration
   Number
    	
 
    	
Registration
   Date
    	
 
    	
Expiration
   Date
    	
 
    
	
US
    	
 
    	
KEVEYIS
    	
 
    	
Active
    	
 
    	
86/724,075
    	
 
    	
Aug 13, 2015
    	
 
    	
5,034,655
    	
 
    	
Sept 6, 2016
    	
 
    	
Sept 6, 2026
    	
 
    

 

Owner: Taro Pharmaceuticals U.S.A., Inc.

 

30

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

Schedule 2.1(a)(ii)

 

Domain Names

 

	
 
    	
keveyis.com
    
	
 
    	
keveyis.net
    
	
 
    	
keveyis.us
    
	
 
    	
keveyiskeys2care.com
    

 

31

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

Schedule 4.3

 

MARKETING COMMITMENT

 

	
 
    	
 
    	
2017
    	
 
    	
2018
    	
 
    	
2019
    	
 
    	
2020
    	
 
    	
2021
    	
 
    	
2022
    	
 
    
	
Strongbridge   SG&A Target*
    	
 
    	
$
    	
[****]
    	
 
    	
$
    	
[****]
    	
 
    	
$
    	
[****]
    	
 
    	
$
    	
[****]
    	
 
    	
$
    	
[****]
    	
 
    	
$
    	
[****]
    	
 
    
																				

 

* in millions of US dollars and as measured by GAAP accounting on Strongbridge’s Financial statements

 

32

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

Schedule 5.1(b)

 

FDA NDA LETTER

 

December   , 2016

 

Attention: Cathleen Michaloski, BSN, MPH, RAC

Sr. Regulatory Project Manager

Division of Neurology Products,

ODE I/ OND/CDER

Central Document Room

5901-B Ammendale Rd.

Beltsville, MD 20705-1266

 

	
Re:
    	
NDA #011366 Keveyis ® (dichlorphenamide tablets USP) 50 mg
    
	
 
    	
GENERAL CORRESPONDENCE-Transfer   of NDA Ownership
    

 

Dear Sir/Madam

 

Reference is made to the NDA 011366 Keveyis® (dichlorphenamide tablets USP) 50 mg.  Taro Pharmaceuticals North America (“Taro”) hereby submits a General Correspondence-Transfer of NDA ownership to notify that we have transferred ownership of this application from Taro to a new sponsor:

 

Strongbridge US Inc.

900 Northbrook Drive, Suite 200, Trevose, PA 19053

Attn: Susan Thornton

e-mail: s.thornton@strongbridgebio.com

Phone: 484-589-0395

 

Effective December XX, 2016, all rights and responsibilities regarding NDA 011366 are transferred to Strongbridge US Inc. (“Strongbridge”). Strongbridge will concurrently notify the Agency of its acceptance of ownership of the designation under separate cover. A complete copy of the NDA 011366, including IND (#127873), has been provided to Strongbridge for their files.

 

If there are any questions, or if additional information is required, please contact me at XXX-XXX-XXXX.

 

Sincerely,

 

33

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

Schedule 5.1(b)

 

FDA NDA LETTER

 

December   , 2016

 

Billy Dunn, M.D.

Division of Neurology Products,

ODE I/ OND/CDER

Central Document Room

5901-B Ammendale Rd.

Beltsville, MD 20705-1266

 

	
Re:
    	
NDA #011366 Keveyis ® (dichlorphenamide tablets USP) 50 mg
    
	
 
    	
Transfer of NDA Ownership
    

 

Dear Dr. Dunn,

 

Pursuant to 21 CFR §314.72 Strongbridge US Inc., hereby notifies the FDA of a change in ownership of NDA 011366 Keveyis®.  As indicated in correspondence dated XXXX, from Taro Pharmaceuticals North America (“Taro”) (copy enclosed), all rights to NDA 011366 Keveyis® (dichlorphenamide tablets USP) 50 mg have been transferred from Taro to Strongbridge, effective December   , 2016 with the following associated address:

 

Strongbridge US Inc.

900 Northbrook Drive, Suite 200

Trevose, PA 19053 USA

Office: 610-254-9200

Fax: 215-355-7389

 

Strongbridge has made arrangements with Taro to obtain a complete copy of the NDA 011366, including supplements, and records that are required to be kept under 21 CFR 314.81. In addition, Strongbridge reserves the right to request a copy of the application from FDA’s files under the fee schedule in 20.45 of FDA’s public information regulations.Strongbridge hereby commits to the agreements, promises, and conditions made by the former owner and contained in the application.

 

Provided herein is a new form FDA 356h signed by the Strongbridge agent of record.

 

With the next NDA annual report, Strongbridge will provide any changes in the drug product’s label or labeling and file the appropriate drug listing for any change in the product NDC.

 

34

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

If there are any questions, or if additional information is required, please contact me at 484-589-0395.

 

Sincerely,

 

Susan Thornton

Vice President, Regulatory Affairs and Acting Head of Quality

Strongbridge US Inc.

900 Northbrook Drive, Suite 200

Trevose, PA 19053 USA

Office: 484-589-0395/Mobile: 215-518-2620

s.thornton@strongbridgebio.com

 

CC: Cathleen Michaloski, BSN, MPH, RAC, Sr. Regulatory Project Manager

 

35

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

Schedule 5.1(b)

 

ORPHAN DESIGNATION ACCEPTANCE LETTER

 

December    , 2016

 

Gayatri R. Rao, MD., JD.

Director, Office of Orphan Products Development

Food and Drug Administration

WO32-5271

10903 New Hampshire Avenue

Silver Spring, MD 200993-002

 

	
RE:
    	
Designation #10-3142
    
	
 
    	
Acceptance of   Ownership
    

 

Dear Dr. Rao,

 

Reference is made to Orphan Designation #10-3142 for the treatment of Treatment of primary hyperkalemic periodic paralysis, primary hypokalemic period paralysis, and related variants  granted by the Office of Orphan Products Development on September 2, 2010 and the supplemental New Drug Application (sNDA) approved by the Division of Neurology Products of  on August 7, 2015. Further reference is made to the subsequent transfer of ownership from Taro Pharmaceuticals, see attached letter dated, to Strongbridge US Inc.

 

Effective today, December   , 2016, Strongbridge US Inc. is hereby officially accepting ownership of Orphan Designation #10-3142. All rights to develop and commercialize Orphan Designation #10-3142 are now the responsibility of, Strongbridge US Inc. with the following associated address:

 

Strongbridge US Inc.

900 Northbrook Drive, Suite 200

Trevose, PA 19053 USA

Office: 610-254-9200

Fax: 215-355-7389

 

Strongbridge has made arrangements with Taro to obtain a complete copy of the Orphan Designation #10-3142.

 

If you have any questions or comments, please feel free to contact me by e-mail at s.thornton@strongbridgebio.com or by phone at (484) 589-0395 [office] or (215)518-2620 [mobile].

 

Sincerely,

 

36

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

Susan Thornton

Vice President, Regulatory Affairs

Strongbridge US Inc.

900 Northbrook Drive, Suite 200

Trevose, PA 19053 USA

Office: 484-589-0395/Mobile: 215-518-2620

s.thornton@strongbridgebio.com

 

37

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

Schedule 5.1(b)

 

FDA IND LETTER

 

December   , 2016

 

Billy Dunn, M.D.

Division of Neurology Products,

ODE I/ OND/CDER

Central Document Room

5901-B Ammendale Rd.

Beltsville, MD 20705-1266

 

	
Re:
    	
IND #127,873 Keveyis ® (dichlorphenamide tablets USP)   50 mg
    
	
 
    	
Transfer of IND Ownership
    

 

Dear Dr. Dunn,

 

Reference is made to Administrative IND #127,873 originally submitted on September 29, 2015 for Keveyis® (dichlorphenamide tablets USP) 50 mg, for the purposes of submitting the  Required Postmarketing Protocol Under 505(o).

 

Pursuant to 21 CFR §312 Strongbridge US Inc., hereby notifies the FDA of a change in ownership of IND #127,873 Keveyis ®.  As indicated in correspondence dated XXXX, from Taro Pharmaceuticals North America (“Taro”) (copy enclosed), all rights to IND127,873 Keveyis® (dichlorphenamide tablets USP) 50 mg have been transferred from Taro to Strongbridge, effective December   , 2016 with the following associated address:

 

Strongbridge US Inc.

900 Northbrook Drive, Suite 200

Trevose, PA 19053 USA

Office: 610-254-9200

Fax: 215-355-7389

 

Provided herein is a new form FDA 1571 signed by the Strongbridge agent of record.

 

Strongbridge has made arrangements with Taro to obtain a complete copy of the IND #127,873, including amendments, and records. Strongbridge hereby commits to the agreements, promises, and conditions made by the former owner and contained in the application.

 

If there are any questions, or if additional information is required, please contact me at 484-589-0395

 

Sincerely,

 

38

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

Susan Thornton

Vice President, Regulatory Affairs and Acting Head of Quality

Strongbridge US Inc.

900 Northbrook Drive, Suite 200

Trevose, PA 19053 USA

Office: 484-589-0395

Mobile: 215-518-2620

s.thornton@strongbridgebio.com

 

CC: Cathleen Michaloski, BSN, MPH, RAC, Sr. Regulatory Project Manager

 

39Exhibit 10.4

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

EXECUTION COPY

 

SUPPLY AGREEMENT

 

between

 

TARO PHARMACEUTICALS NORTH AMERICA, INC.

 

and

 

STRONGBRIDGE BIOPHARMACEUTICALS PLC

 

Effective as of

 

December 12, 2016

 

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

SUPPLY AGREEMENT

 

TABLE OF CONTENTS

 

	
 
    	
 
    	
Page
    
	
 
    	
 
    	
 
    
	
SUPPLY AGREEMENT
    	
1
    
	
 
    	
 
    	
 
    
	
ARTICLE I.   DEFINITIONS
    	
1
    
	
1.1
    	
Definition
    	
1
    
	
1.2
    	
Interpretation
    	
6
    
	
 
    	
 
    	
 
    
	
ARTICLE II.   PAYMENTS & REPORTING
    	
7
    
	
2.1
    	
Payments
    	
7
    
	
 
    	
 
    	
 
    
	
ARTICLE III.   MANUFACTURE AND SUPPLY
    	
8
    
	
3.1
    	
Manufacture and Supply
    	
8
    
	
3.2
    	
Ordering/Forecasting/Inventory
    	
9
    
	
3.3
    	
Minimum Ordering;   Economic Non-Viability
    	
10
    
	
3.4
    	
Materials and Components
    	
10
    
	
3.5
    	
Use of Forms
    	
10
    
	
3.6
    	
Labeling
    	
10
    
	
3.7
    	
Delivery
    	
11
    
	
3.8
    	
Rejection and No   Returns to Seller
    	
11
    
	
3.9
    	
Buyer Inspection
    	
12
    
	
3.10
    	
Inability to Supply
    	
13
    
	
 
    	
 
    	
 
    
	
ARTICLE IV.   REGULATORY AND QUALITY RESPONSIBILITIES
    	
14
    
	
4.1
    	
Regulatory Matters
    	
14
    
	
4.2
    	
Quality Agreement
    	
14
    
	
4.3
    	
Changes in   Specifications and Process
    	
15
    
	
4.4
    	
Product Complaints
    	
15
    
	
4.5
    	
Pharmacovigilance   Agreement
    	
16
    
	
4.6
    	
Recalls, Withdrawals,   Field Alerts and Other Field Corrections
    	
16
    
	
4.7
    	
Regulatory Inspections
    	
17
    
	
4.8
    	
PDUFA
    	
17
    
	
4.9
    	
Stability
    	
17
    
	
 
    	
 
    	
 
    
	
ARTICLE V.   REPRESENTATIONS, WARRANTIES AND COVENANTS
    	
17
    
	
5.1
    	
Mutual Representations   and Warranties
    	
17
    
	
5.2
    	
Product Warranty
    	
18
    
	
5.3
    	
No Other   Representations and Warranties
    	
18
    
	
5.4
    	
No Reliance by Third   Parties
    	
18
    
	
 
    	
 
    	
 
    
	
ARTICLE VI. INTELLECTUAL   PROPERTY AND CONFIDENTIAL INFORMATION
    	
18
    
	
6.1
    	
Ownership of   Pre-Existing Intellectual Property Rights
    	
18
    

 

i

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

	
6.2
    	
Confidential   Information, Publicity and Publication
    	
19
    
	
6.3
    	
Publicity
    	
20
    
	
6.4
    	
Filing Requirements
    	
20
    
	
6.5
    	
Compliance with   Applicable Law
    	
21
    
	
 
    	
 
    	
 
    
	
ARTICLE VII. TERM   AND TERMINATION
    	
21
    
	
7.1
    	
Term
    	
21
    
	
7.2
    	
Termination
    	
21
    
	
7.3
    	
Effect of Termination
    	
22
    
	
 
    	
 
    	
 
    
	
ARTICLE VIII.   INDEMNIFICATION, INSURANCE AND DISPUTE RESOLUTION
    	
23
    
	
8.1
    	
Indemnification
    	
23
    
	
8.2
    	
Dispute Resolution
    	
26
    
	
8.3
    	
Limitation of Liability
    	
27
    
	
8.4
    	
Insurance
    	
27
    
	
 
    	
 
    	
 
    
	
ARTICLE IX.   MISCELLANEOUS
    	
28
    
	
9.1
    	
Assignment
    	
28
    
	
9.2
    	
Counterparts
    	
28
    
	
9.3
    	
Force Majeure
    	
28
    
	
9.4
    	
Further Assurances
    	
28
    
	
9.5
    	
Modification
    	
28
    
	
9.6
    	
Independent Contractors
    	
28
    
	
9.7
    	
Governing Law;   Jurisdiction
    	
28
    
	
9.8
    	
Language
    	
29
    
	
9.9
    	
Article Headings
    	
29
    
	
9.10
    	
Notices
    	
29
    
	
9.11
    	
Third Parties
    	
30
    
	
9.12
    	
Waiver
    	
30
    
	
9.13
    	
Severability
    	
30
    
	
9.14
    	
Entire Agreement
    	
30
    
	
9.15
    	
Conflict
    	
30
    
	
9.16
    	
Drafting Ambiguities
    	
30
    
	
9.17
    	
International Sale of   Goods Act
    	
31
    

 

ii

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

SUPPLY AGREEMENT

 

TABLE OF SCHEDULES AND EXHIBITS

 

	
SCHEDULE 2.1(a)
    	
 
    	
TRANSFER PRICE
    
	
 
    	
 
    	
 
    
	
SCHEDULE 3.1
    	
 
    	
PRODUCT SUPPLY DETAILS
    
	
 
    	
 
    	
 
    
	
SCHEDULE 3.3
    	
 
    	
DELIVERY SCHEDULE FOR MINIMUM ORDER QUANTITIES
    
	
 
    	
 
    	
 
    
	
SCHEDULE 3.6
    	
 
    	
PROCEDURE FOR LABELING CHANGE
    
	
 
    	
 
    	
 
    
	
EXHIBIT A
    	
 
    	
QUALITY AGREEMENT
    
	
 
    	
 
    	
 
    
	
EXHIBIT B
    	
 
    	
PHARMACOVIGILANCE AGREEMENT
    

 

iii

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

SUPPLY AGREEMENT

 

This Supply Agreement dated as of December 12, 2016 (the “Effective Date”), is by and between Taro Pharmaceuticals North America, Inc. a company organized under the laws of the country of Cayman Islands with a place of business at Harbour Place, 103 South Church Street, Grand Cayman KY1-1202, Cayman Islands (“Seller”) and Strongbridge Biopharmaceuticals plc, a company organized under the laws of Ireland, having its Company’s registered office at Arthur Cox Building, Earlsfort Terrace, Dublin 2, Ireland and having its principal U.S. place of business at 900 Northbrook Drive, Suite 200, Trevose, PA 19053 (“Buyer”).  Buyer and Seller are sometimes collectively referred to herein as the “Parties” and separately as a “Party.”

 

WHEREAS, Seller has developed the Product (defined below);

 

WHEREAS, Seller has secured the Regulatory Approval required in order to promote, market and sell the Product in the United States as a treatment for patients suffering from periodic paralysis;

 

WHEREAS, Seller and Buyer are parties to that certain Asset Purchase Agreement, dated December 12, 2016 (the “APA”) pursuant to which Buyer acquired the Product NDA and obtained the exclusive right to market, distribute and sell the Product in the Territory (defined below) under the Trademark (as defined in the APA);  and

 

WHEREAS, the Parties agree to enter into this Supply Agreement to govern the purchase and sale of the Product from Seller (or its Affiliate) to Buyer (or its Affiliate) for marketing, distribution and sale in the Territory.

 

NOW, THEREFORE, in consideration of the mutual covenants, agreements and stipulations set forth herein, the receipt and legal sufficiency of which are hereby mutually acknowledged, the Parties hereby agree as follows.

 

ARTICLE I.
  DEFINITIONS

 

1.1          Definition.  As used in this Agreement, the following terms, whether used in the singular or plural, shall have the following meanings:

 

“AAA” has the meaning set forth in Section 8.2(b).

 

“Adverse Finding” has the meaning set forth in Section 4.1(c).

 

“Affiliate” means any Person that controls, is controlled by, or is under common control with a Party.  For purposes of this definition, “control” means: (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) entitled to vote for the election of directors or otherwise having the power to vote on or direct the affairs of such Party; and (b) in the case of non-corporate entities,

 

1

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

direct or indirect ownership of at least fifty percent (50%) of the equity interest or the power to direct the management and policies of such non-corporate entities.  With respect to Taro, Affiliate means the following entities:  Taro Pharmaceutical Industries Ltd., Taro International Ltd., Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceutical Laboratories, Inc., Taro Pharmaceuticals Inc., Taro Pharmaceuticals Canada, Ltd., Taro Pharmaceuticals North America, Inc., Taro Pharmaceuticals Europe B.V., Taro Pharmaceuticals (UK) Limited, Taro Pharmaceuticals Ireland Limited, and Taro Hungary KFT, provided that any entity that, after the Effective Date is newly under the control of Taro Pharmaceutical Industries Ltd. or any of the foregoing entities shall be an Affiliate of Taro for purposes of this definition.

 

“Agreement” means this Supply Agreement including all exhibits, schedules and appendices attached hereto.

 

“APA” has the meaning set forth in the Preamble.

 

“API” means the active pharmaceutical ingredient dichlorphenamide, USP.

 

“Applicable Law” means all applicable local, state, national, regional or international statute, law, ordinance, rule, treaty, regulation, common law or other legal requirement, including provisions of all statutes (including the Federal Food, Drug and Cosmetic Act), laws, rules, regulations, administrative codes, ordinances, decrees, orders, decisions, guidance documents (including FDA guidance documents), injunctions, awards, judgments, and permits and licenses of or from governmental authorities, and the rules of any applicable securities exchange.

 

“Arbitrators” has the meaning set forth in Section 8.2(b).

 

“Business Day” means any day other than a day which is a Saturday, a Sunday or federal bank or federal government holiday in the United States.

 

“Buyer” has the meaning set forth in the Preamble.

 

“Buyer Claim” has the meaning set forth in Section 8.1(a).

 

“Buyer Losses” has the meaning set forth in Section 8.1(a).

 

“Buyer Party” has the meaning set forth in Section 8.1(a).

 

“Buyer Specification Change” has the meaning set forth in Section 4.3(a)(i).

 

“cGMP” means the then-current good manufacturing practices of the FDA, as set forth in 21 C.F.R. Parts 210 and 211 and all applicable rules, regulations, guides and guidances.

 

“Claim” has the meaning set forth in Section 8.1(d)(i).

 

“Commercially Reasonable Efforts” with respect to any activity means the efforts and resources that would be used in the performance of the relevant activity in compliance with applicable Law by a Person (engaged in the manufacture and supply or commercialization of

 

2

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

pharmaceutical products, as applicable) of comparable size and resources as the applicable Party with regard to a product at a similar stage in its product life taking into account the following factors to the extent reasonable and relevant: issues of safety and efficacy, product profile, market potential, competitive market conditions, duration of exclusivity or other proprietary position of the product and the potential profitability and economic return of the product, all as measured by the facts and circumstances at the time such efforts are due.  Where this Agreement requires a Party to use Commercially Reasonable Efforts, such efforts and resources that are used by such Party’s Affiliates, agents, sublicensees and licensees, as relevant, shall also be attributed to such Party.

 

“Confidential Information” means (a) any and all information or material that, at any time before or after the date hereof, has been or is provided or communicated to the Recipient by or on behalf of the Disclosing Party pursuant to this Agreement or in connection with the transactions contemplated hereby or any discussions or negotiations with respect to this Agreement; (b) any and all confidential information regarding, related to, or associated with the Product that is disclosed by the Disclosing Party to the Recipient.  Provided, however, that Confidential Information shall not include information which: (i) at the time of disclosure is in the public domain, (ii) after disclosure becomes part of the public domain, except through breach of this Agreement by the Receiving Party, (iii) the Recipient can demonstrate by reasonable proof was in its possession prior to the time of disclosure by the Disclosing Party hereunder, and was not acquired directly or indirectly from the Disclosing Party, (iv) becomes available to Recipient on a non-confidential basis from a Third Party who did not acquire such information directly or indirectly from the Disclosing Party and who is not otherwise prohibited from disclosing such information, or (v) is independently developed by the Recipient without reference to Confidential Information disclosed by the Disclosing Party.

 

“Contract Year” means each successive period of twelve (12) months commencing on April 1 and ending on March 31, provided that the portion of the Term that is prior to April 1, 2017 shall be included in Contract Year 2017 for purposes of Minimum Order Quantities.

 

“Disclosing Party” has the meaning set forth in Section 6.2(b).

 

“Dispute” has the meaning set forth in Section 8.2(b).

 

“DMF” means Taro’s Drug Master File number 26664.

 

“Effective Date” has the meaning set forth in the Preamble.

 

“Extension Term” has the meaning set forth in Section 7.1

 

“Facility” means Seller’s Affiliate’s manufacturing facility located at 14 Hakitor Street, Haifa Bay 2624761, Israel.

 

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

 

“FDC Act” means the United States Federal Food, Drug, and Cosmetic Act, enacted in 1938 as Public Law 75-717, as such may have been amended, and which is contained in Title

 

3

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

21 of the U.S. Code, Section 301 et seq., as amended, and the regulations promulgated thereunder from time to time.

 

“Firm Zone” has the meaning set forth in Section 3.2(b).

 

“Force Majeure” has the meaning set forth in Section 9.3.

 

“Forecast” has the meaning set forth in Section 3.2(a)

 

“Generic Product” means a pharmaceutical product that is therapeutically equivalent to the Product where “therapeutically equivalent” means, with respect to a Product, a drug product that (a) is approved under 21 U.S.C. 355(j) or 21 U.S.C. 355(b)(2) (or any respective successor law),  (b) is rated by the FDA to be therapeutically equivalent to such Product, and (c) is legally substitutable for such Product at the pharmacy under Applicable Law.

 

“Initial Term” has the meaning set forth in Section 7.1.

 

“Label or Labeling” means, with respect to finished goods Product, means all labels and other written, printed, or graphic matter (i) on the Product containers or wrappers, or (ii) accompanying the Product, provided, however, Label shall not include any embossing or other markings directly on the Product tablet.

 

“Latent Defect” means any failure of a Product to meet Specifications or otherwise comply with cGMP that either (i) existed at the time of acceptance but was not discovered at such time or (ii) arose as a result of any condition existing before the expiration of the shelf life of the Product, by no fault of Buyer or its Affiliates, sublicensees, distributors, wholesalers or its or their customers.

 

“Lifecycle Product” means a pharmaceutical product containing the API that is a natural evolution or line extension of the Product and is developed by or on behalf of Strongbridge for commercialization in the Territory.

 

“Losses” means any costs, losses, liabilities, damages, lawsuits, deficiencies, claims, fines, penalties, interest and expenses (including reasonable fees and disbursements of attorneys), in all cases subject to any applicable exclusions of damages and limitations on liability hereunder.

 

“Manufacture” or “Manufacturing” means the activities ordinarily undertaken by a manufacturer of an active pharmaceutical ingredient or finished good pharmaceutical product to manufacture such active pharmaceutical ingredient or finished good product, including the planning, purchasing, manufacture, processing, compounding, storage, filling, testing, sample retention, stability testing, labelling, packaging and release of the Products.

 

“Minimum Order Quantities” has the meaning set forth in Section 3.3.

 

“NDA” means a New Drug Application as defined in the U.S. Federal Food, Drug, and Cosmetic Act and all applicable regulations promulgated thereunder.

 

4

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

“NDC” means the National Drug Code, which is the ten digit code, including the labeler code, product code and package code, with respect to a pharmaceutical product registered by a company with the FDA in accordance with Applicable Law.

 

“New York Courts” has the meaning set forth in Section 9.7.

 

“Orange Book” means the then-current edition of FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations” and any then current supplement to such publication, as referred to in 21 C.F.R. §314.3.

 

“Party” or “Parties” has the meaning set forth in the Preamble.

 

“Person” means any natural person, corporation, unincorporated organization, partnership, association, joint stock company, joint venture, limited liability company, trust or government, or any agency or political subdivision of any government, or any other entity.

 

“Pharmacovigilance Agreement” has the meaning set forth in Section 4.5.

 

“Prime Rate” means the rate of interest that Citibank N.A. lists as its prime lending rate in effect on the due date of the applicable payment, or if such rate is not available, the prime lending rate listed in the New York City, United States version of The Wall Street Journal in effect on the due date of the applicable payment.

 

“Product” means the following finished products Manufactured for sale in the Territory: KEVEYIS® (dichlorophenamide) 50 mg tablets in labeled final packaging in accordance with the Specifications.

 

“Product Action” has the meaning set forth in Section 4.6.

 

“Product Claims” means Third Parties’ actual or threatened demands or causes of action related to Product that seek monetary or equitable relief for injuries or deaths to the extent caused by the failure of Seller to deliver Products under this Agreement that meet Specifications.

 

“Product NDA” means New Drug Application No. 011366, including all amendments and supplements thereto for Keveyis® (dichlorphenamide) 50 mg tablets.

 

“Purchase Order” has the meaning set forth in Section 3.2(c).

 

“Quality Agreement” has the meaning set forth in Section 4.2.

 

“Recipient” has the meaning set forth in Section 6.2(b).

 

“Regulatory Approval” means, with respect to the Product, all approvals, product and/or establishment licenses, registrations or authorizations of any Regulatory Authority including, without limitation, approval of any NDA, necessary for the manufacturing, use, storage, import, transport and sale of the Product.

 

5

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

“Regulatory Audit Materials” has the meaning set forth in Section 4.7.

 

“Regulatory Authority” means any federal, national, state or local regulatory agency, department, bureau or other governmental entity, including the FDA, with authority over the Manufacture or commercialization (including approval of Regulatory Approvals) of the Product in the Territory.

 

“Remediation Plan” ha the meaning set forth in Section 3.10(b).

 

“Seller” has the meaning set forth in the Preamble.

 

“Seller Claim” has the meaning set forth in Section 8.1(b).

 

“Seller Losses” has the meaning set forth in Section 8.1(b).

 

“Seller Party” has the meaning set forth in Section 8.1(b).

 

“SKU” means particular form and package size of Product unless the Parties agree otherwise in writing.

 

“Specifications” means the specifications with respect to the Product as set forth in the NDA.

 

“Supply Price” has the meaning set forth in Section 2.1(a).

 

“Term” means collectively, the Initial Term and the Extension Term(s) (if any).

 

“Territory” means the United States of America and its territories and possessions.

 

“Third Party” means any Person other than Buyer or Seller, or an Affiliate of either of them.

 

“Third Party Complaints” has the meaning set forth in Section 4.4.

 

“Units of Product” means a bottle of Product containing one hundred (100) tablets.

 

1.2          Interpretation.

 

(a)           Whenever any provision of this Agreement uses the term “including” (or “includes”), such term shall be deemed to mean “including without limitation” and “including but not limited to” (or “includes without limitation” and “includes but is not limited to”) regardless of whether the words “without limitation” or “but not limited to” actually follow the term “including” (or “includes”);

 

(b)           Capitalized terms used but not otherwise defined in this Agreement shall be governed by the meaning set forth in the APA;

 

(c)           All definitions set forth herein shall be deemed applicable whether the words defined are used herein in the singular or the plural;

 

6

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

(d)           Wherever used herein, any pronoun or pronouns shall be deemed to include both the singular and plural and to cover all genders;

 

(e)           The recitals set forth at the start of this Agreement, along with the Exhibits and Schedules to this Agreement, and the terms and conditions incorporated in such recital, Exhibits and Schedules shall be deemed integral parts of this Agreement and all references in this Agreement to this Agreement shall encompass such recitals, Exhibits and Schedules and the terms and conditions incorporated in such recitals, Exhibits and Schedules, provided, that in the event of any conflict between the terms and conditions of this Agreement and any terms and conditions set forth in the Exhibits and Schedules, the terms of this Agreement shall control;

 

(f)            The Agreement shall be construed as if both Parties drafted it jointly, and shall not be construed against either Party as principal drafter;

 

(g)           Unless otherwise provided, all references to Sections and Schedules in this Agreement are to Sections and Schedules of and to this Agreement;

 

(h)           Any requirements of notice or notification by one Party to another shall be construed to mean written notice in accordance with Section 9.10; and

 

(i)            Wherever used, the word “shall” and the word “will” are each understood to be imperative or mandatory in nature and are interchangeable with one another.

 

ARTICLE II.
  PAYMENTS & REPORTING

 

2.1          Payments.

 

(a)           Supply Price.  The per unit supply price for the Product to be purchased by Buyer from Seller pursuant to the terms of this Agreement is set forth on Schedule 2.1(a) (as such price may be adjusted in accordance with Schedule 2.1(a).  Upon the first sale in the Territory of a Generic Product, the supply price as set forth on Schedule 2.1(a) shall be reduced to fifty percent (50%) of the amount set forth on such Schedule.

 

(b)           Late Payments.  Any payment due Seller from Buyer that is past due under this Agreement shall bear interest at a rate equal to the lesser of (i) Prime Rate plus two percent (2%) per year, or (ii) the maximum rate permitted by Applicable Law, calculated based on the number of days that the payment is delinquent.

 

(c)           Method of Payment.  Buyer shall make payments to Seller of all undisputed amounts owed to Buyer not later than forty-five (45) days after Seller’s receipt of an invoice therefor, in lawful money of the United States by electronic transfer to an account designated by Seller, or by such other means as may be agreed in advance by both Parties.

 

7

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

(d)           Taxes.

 

(i)            Seller shall be responsible for and shall pay all taxes payable on any Seller income or any payments by Buyer to Seller.  Buyer shall be responsible for and shall pay all taxes payable on any Buyer income.  Buyer and Seller shall bear sole responsibility for payment of compensation to their respective personnel, employees or subcontractors and for all employment taxes and withholding with respect to such compensation pursuant to Applicable Law.

 

(ii)           Buyer shall have the right to withhold taxes in the event that the income tax law in any country requires the withholding of taxes on amounts paid hereunder to Seller.  Any tax, duty or other levy paid or required to be withheld by Buyer on account of Supply Price or other payments payable to Seller under this Agreement shall be deducted from the amount of Supply Price or other payments due Seller.  Buyer shall secure and promptly send to Seller proof of such taxes, duties or other levies withheld and paid by Buyer or its Affiliates for the benefit of Seller.  Each Party agrees to cooperate with the other Party in claiming exemptions from such deductions or withholdings under any agreement or treaty from time to time in effect.

 

(iii)          Seller shall indemnify and hold Buyer fully harmless from any amounts conclusively determined to be owed to any taxing or other governmental authority as a result of any finding that the payments under this Agreement are not properly treated as a supply or transfer price for the Product sold hereunder.  If Buyer is assessed tax in respect of the foregoing, Seller shall have the right (but not the obligation to assume the defense of Buyer and represent Buyer, at Seller’s cost, before the taxing authority.  Failure by Buyer to provide notice to Seller with fifteen (15) days of such tax assessment shall relieve Seller of any responsibility to indemnify Buyer under this Section 2.1(d)(iii) but solely to the extent of any prejudice to Taro arising from such failure.

 

ARTICLE III.
  MANUFACTURE AND SUPPLY

 

3.1          Manufacture and Supply.

 

(a)           During the Term and subject to the terms and conditions of this Agreement, Seller agrees to manufacture and supply (or have manufactured and supplied) to Buyer the Minimum Order Quantities (defined below) and the quantities ordered by Buyer pursuant to Purchase Orders accepted by Seller in accordance with Section 3.2.  Buyer agrees to exclusively purchase from Seller, the Product for sale in the Territory.  Seller shall not move the Manufacturing operations of the API or Product finished goods from the Facility without twelve (12) months’ prior written notice to Buyer.

 

(b)           The Product shall be manufactured and supplied in accordance with the terms of this Agreement, the Quality Agreement and Applicable Law.

 

(c)           In the event that Buyer obtains Regulatory Approval for any Lifecycle Product, Buyer agrees to offer Seller the first right to negotiate the terms for the manufacture and supply of such Lifecycle Product.

 

8

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

3.2          Ordering/Forecasting/Inventory.

 

(a)           During the Term, Buyer shall provide to Seller a rolling good faith projection for the next succeeding twenty-four (24) month (or such shorter period remaining under the term of this Agreement) (the “Forecast”) of the monthly quantities of the Product that Buyer intends to purchase during such 24-month period.  Buyer shall provide such projections to Seller on or before the first day of each month during the Term.  Such projections shall be consistent with the Minimum Order Quantities set forth in Section 3.3(a).

 

(b)           The volume requirements for the Product for each of the first six (6) months of each Forecast will be a binding commitment to purchase the specified quantities of Products (such six-month period shall be referred to herein as the “Firm Zone”).  In the event Buyer does not provide an updated monthly Forecast by the first day of each month, Seller may at its discretion include the first month of the previous non-binding Forecast as part of next Firm Zone.  The Product quantities specified for months seven (7) through twenty-four (24) of each Forecast shall be non-binding estimates of Product requirements.

 

(c)           Buyer shall deliver to Seller a purchase order not less than one hundred twenty (120) days prior to the requested delivery date for the Product (“Purchase Order”).  Each Purchase Order shall specify the quantities of Product requested, the delivery date and the destination for delivery of the Product.  The Purchase Order may be delivered electronically or by other means to such Person or location as Seller shall designate.  Seller shall accept all Purchase Orders that comply with the provisions of this Agreement and shall confirm each Purchase Order in writing within ten (10) Business Days of receipt and after such confirmation. Seller shall meet Buyer’s requirements and deliver the Product according to such Purchase Order, provided that it shall not be considered a breach of this Agreement if Seller delivers the Product up to fifteen (15) days following the delivery date specified on the relevant Purchase Order so long as Seller uses Commercially Reasonable Efforts to deliver the Product by the relevant delivery date specified in the Purchase Order.  Seller may at its discretion accept changes to any Purchase Order submitted by Buyer.  Purchase Order quantities delivered by Seller may vary by plus or minus (±) ten percent (10%) from the quantities ordered.  Such variances shall not constitute a breach of contract by Seller, provided that Buyer shall only be obligated to pay for the amount of invoiced Product actually received.  The last Purchase Order issued must be received no later than one hundred twenty (120) days prior to the expiration or termination of the Term.

 

(d)           Should a Purchase Order call for quantities of Product in excess of one hundred and twenty percent (120%) of the immediately preceding estimated requirements previously provided to Seller in the Forecast, Seller will use its Commercially Reasonable Efforts, but shall not be obligated, to supply any portion of the excess quantities requested by Buyer.

 

(e)           Buyer shall promptly reimburse Seller for its direct costs and associated expenses, which costs and expenses shall be evidenced by written documentation, that arise from any cancelled or materially modified Purchase Order that has been consented to by Seller.  Seller shall use Commercially Reasonable Efforts to mitigate such costs and expenses upon learning of a cancelled or modified Purchase Order.

 

9

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

3.3          Minimum Ordering; Economic Non-Viability.

 

(a)           Buyer agrees to purchase the minimum Units of Product per Contract Year, according to the following schedule (the “Minimum Order Quantities”):

 

(i)            Contract Year 2017:  [****] Units of Product

 

(ii)           Contract Year 2018:  [****] Units of Product

 

(iii)          Contract Year 2019:  [****] Units of Product

 

(iv)          Contract Year 2020:  [****] Units of Product

 

(v)           Contract Year 2021:  [****] Units of Product

 

(vi)          Contract Year 2022:  [****] Units of Product

 

(b)           Upon the first sale in the Territory of a Generic Product, the Minimum Order Quantities set forth above shall be reduced to fifty percent (50%) of the amounts set forth above.

 

(c)           If, in accordance with the time periods set forth in Section 7.2(b), the gross profit less the cost of goods for the Units of Product that is difference between the Minimum Order Quantities and the actual quantities of Units of Product dispensed by Buyer is less than [****] Dollars ($[****]), Buyer shall promptly notify Seller.  The Parties shall promptly meet and discuss in good faith the projection made by Buyer; provided however, that Seller shall not be obligated to modify the Minimum Order Quantities.  In the event that the Parties are unable to reach a decision within twenty (20) Business Days of its meeting to discuss the projection made by Buyer, either Party may terminate this Agreement pursuant to Section 7.2(b).

 

3.4          Materials and Components.  Buyer shall reimburse Seller for its reasonable out of pocket costs for materials or components if Seller is unable to use the materials or components ordered to meet Buyer’s Firm Zone requirements due to Buyer’s (i) cancelled Purchase Orders; or (ii) failure to meet Firm Zone purchase requirements or (iii) changes in packaging or Labeling requested by Buyer, in each case where Seller is unable to use such materials and components in supplying a future Purchase Order.

 

3.5          Use of Forms.  In ordering and delivering Product, as the case may be, Seller and Buyer may use their respective standard forms and documents in ordering and delivering the Product, provided that nothing in those forms or documents shall be construed to modify or amend the terms and conditions of this Agreement, and, in the case of any conflict herewith, the terms and conditions of this Agreement shall control.

 

3.6          Labeling.  The process for determining the initial Product labelling and the process for changing Product labelling (including any artwork changes) is set forth on Schedule 3.6.

 

10

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

3.7          Delivery.

 

(a)           Subject to Section 3.2(c), Seller shall deliver to Buyer the Product ordered under a Purchase Order by the delivery date specified in the Purchase Order.  The Minimum Order Quantities shall be delivered in accordance to the schedule set forth on Schedule 3.3.  Nothing herein shall be construed as limiting the Parties’ ability to mutually agree in writing to any adjustment to a delivery date without any modification to a then outstanding Purchase Order or Forecast.  Seller (or its Affiliate) shall provide an invoice, batch record, certificate of analysis and certificate of conformance to Buyer for each lot of Product shipped in accordance with the Quality Agreement to Buyer.

 

(b)           Delivery of Product ordered hereunder from Seller (or its Affiliate) to Buyer shall be FCA Seller’s facility in Cranbury Twp., NJ (Incoterms 2010), whereby Seller will load Product onto the transport vehicle of Buyer’s designated carrier and Buyer shall bear all risk of loss or damage, and costs of insurance and shipping associated with the Product once such Product is loaded and tendered to Buyer’s designated carrier (or its agents or representatives) at such Seller facility.

 

(c)           Title to and risk of loss of Product shall automatically transfer to Buyer when Seller loads the shipment onto Buyer’s designated carrier’s transport vehicle and Buyer shall bear all risk of loss associated with the Product thereafter.  Seller will store Product in accordance with the Quality Agreement in one of its facilities.  Seller will send Buyer electronic copies of the batch records, certificates of analysis and certificate of conformance relating to the Product on or before the date of delivery.

 

3.8          Rejection and No Returns to Seller.

 

(a)           Within thirty (30) days of receipt of any Product supplied under this Agreement, Buyer may perform a visual inspection with reasonable care to determine whether the Product meets the Specifications and in accordance with the Quality Agreement and the requirements of this Agreement or is otherwise obviously damaged.  Buyer shall either refuse acceptance of any portion of the Product that fails to meet Specifications or is otherwise obviously damaged within thirty (30) days of receipt or, with respect to a Latent Defect that is not discoverable upon a reasonable visual inspection, revoke acceptance within thirty (30) days of discovery of the Latent Defect using Commercially Reasonable Efforts or otherwise.  Otherwise, the shipment will be deemed accepted by Buyer.

 

(b)           If Buyer wishes to refuse or revoke acceptance, Buyer shall within such applicable thirty (30) day time period, inform Seller in writing of its refusal to accept or revocation of acceptance of the shipment, and the reasons therefore.  Such report shall be provided as a noncompliance report (NCR) to the Seller that includes the quality inspection report upon receipt and reasons for refusal based upon scientific evidence.  In the event that Buyer refuses or revokes acceptance, Seller, upon confirmation of the reasons for refusal or revocation of the Product shall replace the defective Product.  Provided that Seller is able to do so, Seller’s replacement of the defective Product shall be Buyer’s sole and exclusive remedy against Seller for delivery of non-conforming Product, except that Buyer shall also retain its rights of reimbursement for recall expenses as provided for under and subject to the terms of

 

11

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

Section 4.6(c).  In the event that four consecutive batches of Product manufactured hereunder fail to meet Specifications, Seller shall promptly notify Buyer of such failure, and either Party shall have a right to notify the other Party so as to require the Parties to engage in the process set forth in Section 3.10, and such notice shall constitute the notice required under Section 3.10(a).  Following completion of the process set forth in Section 3.10, provided that Seller is able to replace the defective Product in compliance with a Remediation Plan as may be agreed between the Parties in accordance therewith, Seller shall not be deemed to be in material breach of this Agreement.

 

(c)           If the Parties do not agree on the refusal or rejection of Product, then either Party may refer the matter for final review to an independent Third Party of national reputation, reasonably acceptable to both Parties, for the sole purpose of determining whether or not the Product conforms to Specifications and was properly rejected or refused.  Any determination by such Third Party shall be binding upon both Parties.  The cost of any such review and evaluation by an independent Third Party shall be borne by Buyer if it is determined that the Product conforms to the requirements of this Agreement, and by Seller if it is determined that it does not.  Seller shall, as promptly as is reasonably possible, either make replacement delivery of conforming Product, with the Party responsible for the defect bearing the reasonable expenses associated therewith.  Buyer shall return to Seller any non-conforming Product and reasonable destruction costs shall be borne by the Party responsible for the defect.  The procedure set forth in this subsection (c) shall be the sole and exclusive procedure by which replacement shall be made of non-conforming Product.

 

(d)           Except as set forth in this Section 3.8 with respect to initial inspection of Product and with respect to latent defects, all sales of Products from Seller to Buyer shall be deemed final and non-returnable to Seller, and Buyer shall be responsible for and shall process any and all aspects of its customer returns of Product to Buyer.  For the avoidance of doubt, if Buyer elects to have Seller replace any revoked or rejected Product, then the Parties acknowledge and agree that Seller shall have a commercially reasonable period of time in which to cure the defect resulting in the revocation or rejection; provided, however, that such cure period shall not exceed one hundred and twenty (120) days unless otherwise agreed by the Parties prior to the expiration of such 120-day cure period.

 

3.9          Buyer Inspection.  Buyer shall have the right, not more than once biennially (or more than once biennially if Buyer has a commercially reasonable basis to believe there is cause, which cause shall be specifically related to, or would reasonably be expected to have a material adverse impact on, the Product delivered pursuant to this Agreement), and upon providing Seller with thirty (30) days advance written notice, to inspect Seller’s Facility (provided that Seller shall permit such inspection as promptly as practicable, and in no event later than five (5) days following written notice from Buyer, in the event that such inspection is for cause), on a confidential basis and during normal business hours, for the sole purposes of ensuring such Facility is in compliance with applicable cGMP and Applicable Law, solely relating to the manufacture and storage of the Product.  Buyer’s inspection rights under this Section shall not extend to any portions of the Facility, documents, records or other information which do not directly relate to the manufacture and supply of the Product under this Agreement.  Further, Buyer’s inspection rights under this Section shall be limited in duration to no more than one (1) Business Days for API-related inspections and independently two (2) Business Days for

 

12

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

finished-goods-related inspections, and shall be limited to no more than two (2) Buyer inspectors at any one time.  Inspection by Buyer or documentation provided to Buyer related to any of Seller’s suppliers or subcontractors related to the manufacturing and storage of Product is subject to consent of such Seller supplier or subcontractor.  Seller will use Commercially Reasonable Efforts to obtain such consent.

 

3.10        Inability to Supply.

 

(a)           Seller shall notify Buyer promptly upon becoming aware of an event of Force Majeure or any other event that would render Seller unable to supply the quantity of conforming Product to Buyer that Seller is required to supply pursuant to a confirmed Purchase Order or the Minimum Order Quantities.  Promptly following such notice, Seller shall prepare a plan to address any deficiencies or cause(s) of such inability to supply (including timelines therefor) and provide a draft of the plan to Buyer.

 

(b)           Promptly following receipt thereof, Buyer shall review such plan and provide comments thereto, or shall notify Seller that it has no such comments (in which case the plan shall be deemed to have been agreed between the Parties for purposes of the immediately following sentence).  The Parties promptly thereafter shall discuss Buyer’s comments, if any, and negotiate, acting reasonably, to attempt to agree on a remediation plan (any such plan agreed between the Parties, a “Remediation Plan”).

 

(c)           If the Parties are unable to agree on a Remediation Plan, either Party may, upon twenty (20) days’ written notice to the other Party, submit the disagreement to a Third Party expert mutually agreeable to the Parties and having at least fifteen (15) years’ experience as a senior executive in the pharmaceutical industry with oversight responsibility for manufacturing operations for oral dosage pharmaceutical products.  On the last day of the foregoing twenty (20) day notice period, each Party shall submit a version of a plan (or if such Party believes no plan would reasonably solve the inability to supply, a detailed explanation of the reasons for such belief) to such expert along with explanation as a to why it rejects the other Party’s proposal.  Not later than thirty (30) days following submission of proposals by the Parties, the expert shall adopt one of the two proposals submitted by the Parties or determine that neither proposal is reasonably likely to resolve the inability to supply issue, and shall have no ability to alter either proposal.  If one Party’s proposal prevails (either as a plan chosen by the expert or if such proposal is that no plan would reasonably resolve the inability to supply and the expert does not adopt the other Party’s plan), then the non-prevailing Party shall pay the fees and expenses of the expert (and otherwise such fees shall be shared equally by the Parties).  If the expert adopts a remediation plan submitted by a Party, such plan shall become the Remediation Plan and be deemed agreed by the Parties.  The expert’s determination shall be final and binding on the Parties.

 

(d)           Provided that a Remediation Plan is agreed by the Parties, the Seller is able to remedy a supply failure materially in compliance such Remediation Plan (including the timelines therein), Seller shall not be deemed to be in material breach of this Agreement.  If despite Seller’s effort, Seller determines that it is unable to remedy the supply failure, Seller shall notify Buyer and either Party may terminate this Agreement pursuant to Section 7.2(f).

 

13

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION. 

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

ARTICLE IV.
  REGULATORY AND QUALITY RESPONSIBILITIES

 

4.1          Regulatory Matters.

 

(a)           Seller shall obtain and maintain all Regulatory Approvals and other permits and licenses that are necessary for Seller to Manufacture the Product for sale to Buyer in accordance with the terms of this Agreement and Applicable Law.

 

(b)           Buyer shall be responsible during the Term to obtain and maintain all Regulatory Approval necessary to market, distribute and sell the Product in the Territory in accordance with Applicable Law.  Buyer agrees to distribute and sell any Product Manufactured and supplied pursuant to a Purchase Order under this Agreement using only a Buyer (or its Affiliate’s) NDC number.  As appropriate, Seller or Seller’s designated supplier shall be listed as the manufacturer on the Label for the Product.  Buyer shall be solely responsible for communications and filings with and submissions to any regulatory agency concerning sales of Product, prices, discounts, rebates, fees, charge-backs, and other payments associated with Buyer’s distribution and sale of the Product.

 

(c)           During the Term, Seller shall within five (5) Business Days after Seller’s receipt thereof (or within two (2) Business Days in the case of a notice that would reasonably result in an obligation of Buyer to report a significant safety issue to the FDA), inform Buyer of any adverse manufacturing notice to Seller that has a negative impact on the manufacture of the Product, including any FDA Form 483 Warning Letter, consent decree, or other regulatory action that directly impacts the Product (each, an “Adverse Finding”).  So long as Seller is taking all reasonable measures to correct and address an Adverse Finding, it shall not be deemed to be in material breach of this Agreement.  Buyer shall be responsible for any required reporting of matters regarding the manufacture, integrity, and conformance to specifications of Product to the FDA in accordance with Applicable Law.

 

(d)           Seller shall be responsible for handling and responding to any FDA or other governmental agency inspections relating to the Facility and Buyer shall be responsible for handling and responding to any FDA or other governmental agency inspection with respect to the Product supplied to Buyer pursuant to this Agreement.  Seller shall, within two (2) Business Days, provide to Buyer any information reasonably requested by Buyer and all information requested by any governmental agency in connection with any governmental inspection, redacted as needed, related to the Product supplied to Buyer hereunder (subject to any confidentiality or privilege restrictions or obligations to which Seller is subject).

 

4.2          Quality Agreement.  The Parties agree to enter into a quality agreement within ninety (90) days of the Effective Date (but in any event, prior to delivery of the Product to Buyer under Buyer’s NDC number) which sets forth (a) the roles and responsibilities of Buyer and Seller with respect to quality system regulations for the Product as required under Applicable Laws, and (b) how the Parties shall interact with each other in connection with same (the “Quality Agreement”), a copy of which shall be attached hereto as Exhibit A when executed by the Parties.

 

14

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION. 

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

4.3          Changes in Specifications and Process.

 

(a)           A change in the Specifications shall only be made in accordance with this Section 4.3 and the Quality Agreement unless otherwise required by Applicable Law.

 

(i)            In the event Buyer desires any change to the Specification, Buyer shall deliver a written request (a “Buyer Specification Change”) to Seller specifying such requested change.  Seller shall evaluate such Buyer Specification Change promptly after Seller’s receipt thereof.  Seller shall have the obligation to accept and implement any Buyer Specification Change unless in its reasonable judgment, after reasonable consultation with Buyer, Seller determines that such Buyer Specification Change is not technically feasible.  If any such proposed change to the Specification requires additional capital expenditure or other expenditures by Seller, Seller shall notify Buyer in writing of the applicable additional capital expenditures, and the Buyer Specification Change shall not be deemed accepted until Buyer has consented in writing to reimburse Seller for the same.  Prior to shipment of any Product Manufactured under the new Specifications, Buyer shall be obligated to purchase any inventory of in-process and Product Manufactured under the unmodified Specifications held by Seller on behalf of Buyer as a result of the binding portions of any Forecast which in-process inventory and Product have been rendered obsolete by such new Specifications.

 

(ii)           In the event that Seller desires any change to the Specification that is not required by Applicable Law or Regulatory Authority, Seller shall deliver a written request (a “Seller Specification Change”) to Buyer specifying such requested change.  Buyer shall evaluate such Seller Specification Change promptly after Buyer’s receipt thereof.  Buyer may accept or deny any Seller Specification Change in its reasonable discretion, including with respect to any allocation of costs therefor, which shall be agreed between the Parties prior to any such acceptance.  If Buyer agrees to the Seller Specification Change and the Specifications are changed based on it, Buyer shall, in reasonable consultation with Seller, determine the date upon which to Manufacture the Product under the new Specifications, taking into account technical and other applicable factors.

 

(b)           Notwithstanding Section 4.3(a), if either Party becomes aware of any Applicable Law or Regulatory Authority that requires a change in the Specifications, that Party shall promptly notify the other Party, and the Parties shall cooperate in a timely manner in connection with any modifications of the Specifications required to meet those requirements.  Any costs associated with a change in Specifications required by Applicable Law or any Regulatory Authority or due to a Third Party supplier’s inability to provide a given material shall be borne by Buyer pro-rata to the unit proportion of Products or components thereof Manufactured for Buyer during the prior twelve (12) month period relative to the units of any other components or products manufactured for Seller or any other licensee or customer of Seller during such period and to which such modifications apply.

 

4.4          Product Complaints.  Each Party shall, within two (2) Business Days after receipt, or in the case of a complaint that would not reasonably result in an obligation of a Party to report a significant safety issue to the FDA, not longer than five (5) Business Days after receipt, provide the other Party with written notice via facsimile or email of all Third Party complaints it receives that relate to, or arise from, the Product (“Third Party Complaints”).

 

15

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION. 

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

Notwithstanding the foregoing, each Party shall use its Commercially Reasonable Efforts to within one (1) Business Day after receipt of notice of a Third Party Complaint provide the other Party with written notice via facsimile or email of all reports of complaints of tampering or contamination that relate to, or arise from, Product.  Seller will investigate all Third Party Complaints associated with the Manufacture of the Product and provide a written summary to Buyer.  Buyer will investigate all other Third Party Complaints associated with the transportation, storage, distribution, sale and use of Product and provide a written summary to Seller.  The Parties will reasonably cooperate with each other concerning the investigation of the Third Party Complaints, including testing of Product and review of documents, and will provide such information as reasonably requested by the other Party in connection with such investigations; provided however, that neither Party shall have any obligation to provide its Confidential Information to the other Party unless required by Applicable Law.  The Parties shall collaborate in developing procedures for providing information on the Third Party Complaints and inquiries and such procedures will be outlined in the Quality Agreement and/or Pharmacoviligance Agreement.  Nothing in this Section 4.4 shall affect the Parties’ obligations with respect to pharmacovigilance reporting, as detailed in the Pharmacoviligance Agreement.

 

4.5          Pharmacovigilance Agreement.  The Parties agree to enter into a pharmacovigilance agreement within forty-five (45) days of the Effective Date which sets forth the pharmacovigilance responsibilities of each Party (the “Pharmacovigilance Agreement”) a copy of which shall be attached hereto as Exhibit B when executed by the Parties.  These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange of adverse experience reports, pregnancy reports, and any other information concerning the safety of the Product.  Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill their obligations under, Applicable Law and reporting obligations to the Regulatory Authorities.

 

4.6          Recalls, Withdrawals, Field Alerts and Other Field Corrections.

 

(a)           Each Party shall promptly, within two (2) Business Days, provide to the other Party any information obtained by it suggesting that a recall, field alert, product withdrawal, or other field action relating to the Product in the Territory (“Product Action”) is or may be necessary.  Further, the Parties shall cooperate with each other in obtaining any additional information that may bear upon whether to initiate a Product Action.  The final decision regarding whether to initiate a Product Action shall rest with Buyer.

 

(b)           Buyer shall provide Seller with prompt notice of any determination by Buyer to initiate a Product Action (provided, Buyer will use its Commercially Reasonable Efforts to provide Seller with such determination within twenty-four (24) hours after such determination is made).  Seller shall provide reasonable cooperation to Buyer in implementing such Product Action.

 

(c)           The reasonable costs of any Product Action (including the reasonable costs of notifying customers, the reasonable costs associated with shipment of the Product from Buyer’s customers, reasonable credits extended to Buyer’s (and its Affiliates) customers as a result of the Product Action, and other reasonable costs incurred) shall be borne by Buyer;

 

16

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION. 

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

provided, however, Seller shall be responsible for all such reasonable costs associated with a Product Action to the extent resulting from any Seller’s failure to deliver Product that meets the Specifications.

 

4.7          Regulatory Inspections.  Seller shall inform Buyer of any FDA or other Regulatory Authority inspection of the Facility within the same Business Day that an authorized agent of any Regulatory Authority notifies Seller that it intends to or does visit the Facility.  Seller shall, within twenty-four (24) hours after receipt by Seller, provide copies to Buyer of all inspection observation reports and other regulatory communications directly related to, or that would have a material adverse effect on the Product, including any Adverse Findings.  Seller shall also provide copies of Seller’s proposed responses to such inspection observation reports and other regulatory communications within three (3) Business Days of their completion (the inspection observation reports, other regulatory communications and Seller’s response are referred to collectively as “Regulatory Audit Materials”).  Buyer will be allowed to review and comment on the Regulatory Audit Materials which directly relate to Product or its manufacture.  For clarity, Seller reserves the right to redact information in such Regulatory Audit Materials that are not directly related to the Manufacture of the Product supplied hereunder.

 

4.8          PDUFA.  Buyer shall be responsible for the Facility fees associated with the Manufacture of the Product supplied hereunder on a pro rata basis, taking into account other products to which such fees are attributed and any part of a year that is not part of the Term.  Such fees for FDA fiscal year 2017 are as follows:  (a) four hundred twenty six thousand eight hundred thirty three dollars and thirty three cents ($426,833.33) for 2017 Establishment Fee; and (b) eighty-one thousand four hundred fifty eight dollars and thirty three cents ($81,458.33) for 2017 Product Fee.

 

4.9          Stability. Seller agrees to continue stability testing for the Product in accordance with the protocol in place as of the Effective Date and shall provide to Strongbridge the data and reports from this stability testing necessary to support filing of extensions for the retest period for API and shelf life for drug product as promptly as practicable following finalization thereof.

 

ARTICLE V.
  REPRESENTATIONS, WARRANTIES AND COVENANTS

 

5.1          Mutual Representations and Warranties.  Each of the Parties hereby represents, warrants and covenants to the other Party as of the Effective Date as follows:

 

(a)           It is an entity duly organized, validly existing and is in good standing under the laws of its jurisdictions of formation, and has all requisite power and authority, corporate or otherwise, to execute, deliver and perform this Agreement.

 

(b)           The execution, delivery and performance of this Agreement have been duly authorized by all necessary corporate action and do not and will not (i) require any consent or approval of its stockholders, (ii) violate any provision of any Applicable Law or any provision of its certificate of incorporation, by-laws or other founding document, or (iii) result in a breach of or constitute a default under any material agreement, mortgage, lease, license,

 

17

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION. 

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

permit or other instrument or obligation to which it is a party or by which it or its properties may be bound or affected.

 

(c)           It (and its Affiliates) are not currently debarred, suspended or otherwise excluded by any government agency from receiving government contracts in the Territory, nor is it, or its Affiliates or any of its employees debarred under the applicable provisions of the Food, Drug, and Cosmetic Act.

 

(d)           It is not under any obligation to any Third Party, or entity, contractual or otherwise, that is conflicting or inconsistent in any respect with the terms of this Agreement or that would impede the diligent and complete fulfillment of its obligations hereunder.

 

(e)           This Agreement is a legal, valid and binding obligation of such Party, enforceable against it in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, moratorium, reorganization or similar laws, from time to time in effect, affecting creditor’s rights generally.

 

5.2          Product Warranty.  Seller represents, warrants and covenants to Buyer the Product supplied pursuant to this Agreement at the time of delivery shall: (a) not be misbranded, mislabeled or adulterated within the meaning of the FDC Act, (b) meet the Specifications, (c) has the minimum product dating set forth on Schedule 3.1; and (d) be free from any lawful security, interest, lien or encumbrances.

 

5.3          No Other Representations and Warranties.  EXCEPT FOR THE EXPRESS WARRANTIES AND REPRESENTATIONS AND COVENANTS CONTAINED IN THIS AGREEMENT OR THE EXHIBITS AND SCHEDULES ATTACHED THERETO, NEITHER BUYER NOR SELLER MAKES, AND EACH HEREBY EXPRESSLY DISCLAIMS, ANY WARRANTIES OR REPRESENTATIONS, EITHER EXPRESS OR IMPLIED, WHETHER IN FACT OR IN LAW, INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.

 

5.4          No Reliance by Third Parties.  The representations and warranties of a Party set forth in this Agreement are intended for the sole and exclusive benefit of the other Parties hereto, and may not be relied upon by any Third Party.

 

ARTICLE VI.
  INTELLECTUAL PROPERTY AND CONFIDENTIAL INFORMATION

 

6.1          Ownership of Pre-Existing Intellectual Property Rights.  Except as expressly provided in this Agreement or the APA:

 

(a)           As between the Parties, any intellectual property rights (including patents, patent applications, know-how, trade secrets, copyrights, trade dress, housemarks and trademarks) owned by either Party and their respective Affiliates on the Effective Date shall remain solely owned by such Party (or their respective Affiliates, as applicable); and

 

18

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION. 

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

(b)           neither Party shall represent or assert that it is the owner of any such intellectual property rights of the other Party (or their respective Affiliates), whether or not such rights are registered.

 

For the avoidance of doubt, the Parties agree that each of the Parties shall have no rights to use any trademark, housemark, copyright, or trade dress, of the other, except expressly provided for under this Agreement or the APA.

 

6.2          Confidential Information, Publicity and Publication.  Buyer and Seller each hereby recognize and acknowledge that the other Party’s Confidential Information constitutes valuable and confidential information.  Subject to other express provisions of this Agreement, the Parties each agree that during the Term, and for a period of five (5) years after the Term:

 

(a)           Any information owned by Buyer as a result of the operation of the APA that remains in the possession or control of Seller on or after the Effective Date shall be deemed to be Confidential Information of Buyer and to have been disclosed by Buyer as Disclosing Party to Seller as Receiving Party for purposes of this ARTICLE VI.

 

(b)           The Parties shall not disclose, directly or indirectly, in any manner whatsoever to any Third Parties any Confidential Information received from the other Party (or its Affiliates, as applicable) (the “Disclosing Party”) without first obtaining the written consent of the Disclosing Party, and the other Party (“Recipient”) shall keep confidential, all of the Disclosing Party’s Confidential Information that is disclosed to Recipient.  Recipient agrees to use the same level of care in safeguarding the Disclosing Party’s Confidential Information that Recipient uses with its own confidential information of a similar nature, but in no event less than reasonable care.  Recipient shall restrict disclosure of the Disclosing Party’s Confidential Information solely to those of its (or its Affiliate’s) employees or representatives having a need to know such Confidential Information in order to accomplish the purposes of this Agreement.  Each Party represents that its respective employees and representatives who receive the Confidential Information of the Disclosing Party are advised by such Party of the confidentiality obligations of this Agreement and shall maintain such Confidential Information in accordance with the confidentiality obligations set forth in this ARTICLE VI.

 

(c)           Recipient shall not use the Disclosing Party’s Confidential Information in any manner whatsoever other than solely in connection with the exercise of its rights and the performance of its obligations under this Agreement or the APA.

 

(d)           In the event Recipient is requested pursuant to, or required by, Applicable Law to disclose any of the Disclosing Party’s Confidential Information, it will, to the extent reasonably practicable and permitted by Applicable Law, notify the Disclosing Party promptly so that the Disclosing Party may seek a protective order or other appropriate remedy or, in the Disclosing Party’s sole discretion, waive compliance with the confidentiality provisions of this Agreement.  At the Disclosing Party’s expense, Recipient will co-operate in all reasonable respects, in connection with any reasonable actions to be taken for the foregoing purpose.  In any event, Recipient may furnish such Confidential Information as requested or required pursuant to Applicable Law (subject to any such protective order or other appropriate remedy) without liability hereunder, provided that the Recipient furnishes only that portion of the

 

19

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION. 

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

Confidential Information which Recipient is advised by its counsel is legally required, and Recipient exercises reasonable efforts to obtain reliable assurances that confidential treatment will be accorded the Disclosing Party’s Confidential Information.

 

(e)           Upon the date of the expiration or termination of this Agreement for any reason, either Party may request in writing, and the other Party shall either: (i) promptly destroy all copies of the requesting Party’s Confidential Information in the possession of the other Party and confirm such destruction in writing to the requesting Party; or (ii) promptly deliver to the requesting Party, at the other Party’s expense, all copies of such Confidential Information in the possession of the other Party, provided, however, the other Party shall be permitted to retain one (1) copy of the requesting Party’s Confidential Information for the sole purpose of determining any continuing obligations hereunder.  Additionally, both Parties shall immediately cease all use of the other Party’s Confidential Information including, without limitation, removing all references to such Confidential Information from its analyses, compilations, studies or other documents unless maintenance of such documentation is required by Applicable Law.  All Confidential Information shall continue to be subject to the terms of this Agreement for the period set forth in this Section 6.2.

 

(f)            Each Party represents and warrants to the other Party that it (or its respective Affiliates, as applicable) has, and shall have, all right, title, and ownership interest in and to its Confidential Information or it has, and shall have, the right to disclose its Confidential Information to the other Party.  Each Party may seek to enforce all rights and legal remedies available under this ARTICLE VI or by law, including, without limitation, injunctive relief, specific performance and other equitable remedies in the event of a breach of the provisions of this ARTICLE VI by the other Party.

 

(g)           Recipient shall cause its Affiliates to observe the terms of this ARTICLE VI hereof, and shall be responsible for any breach of its provisions by any of its Affiliates.

 

(h)           Notwithstanding the provisions of this ARTICLE VI, the Parties agree that nothing contained in this ARTICLE VI shall prevent Recipient in any way whatsoever from disclosing any of the Disclosing Party’s Confidential Information, without obtaining Disclosing Party’s prior consent, to any Affiliate of Recipient or to any Third Party for the purposes of conducting their respective rights and obligations under this Agreement, provided such Third Party has undertaken an obligation of confidentiality similar to such obligations contained in ARTICLE VI herein with respect to the Disclosing Party’s Confidential Information.

 

6.3          Publicity.  Subject to Section 6.4, the Seller and Buyer shall agree on the content of any press release(s), public announcement(s) or other information publicly released by the Parties relating to this Agreement and the APA.

 

6.4          Filing Requirements.  If the execution of or the activities or obligations under this Agreement were to trigger or otherwise instigate a reporting, filing or other disclosure obligation on a Party (or any of its Affiliates) pursuant to Applicable Law, such Party shall notify the other Party as promptly as practicable of such obligation, and provide whatever reasonable opportunity may be available for the other Party to comment on a draft version of

 

20

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION. 

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

any such disclosure. Subject to the foregoing sentence, such Party shall have the right to make any such filing or obligated disclosure.

 

6.5          Compliance with Applicable Law.  Nothing in this Agreement shall be construed as preventing or in any way inhibiting either Party from complying with Applicable Law governing activities and obligations undertaken pursuant to this Agreement, in any manner which it reasonably deems appropriate, including, for example, by disclosing to Regulatory Authorities confidential or other information received from the other Party, subject to Section 6.2(d).

 

ARTICLE VII.
  TERM AND TERMINATION

 

7.1          Term.  This Agreement shall become effective as of the Effective Date and, unless sooner terminated pursuant to Section 7.2 below, shall continue in full force and effect thereafter until the termination of the Orphan Exclusivity Designation granted by the FDA under the NDA (the “Initial Term”) and, thereafter, shall automatically renew for additional two (2) year periods (“Extension Term”) on the same terms unless at least four (4) months prior to the expiration of the then current Term:  (a) a Party makes a written request to the other Party to discuss in good faith new terms for the Agreement for the Extension Term; or (b) a Party notifies the other Party in writing that it desires to terminate the Agreement.  If the Parties agree on the new terms of the Agreement for the Extension Term, this Agreement shall be amended in writing to reflect the new terms.  If the Parties do not agree on the new terms of the Agreement for the Extension Term, either Party may terminate this Agreement under this Section 7.1.

 

7.2          Termination.

 

(a)           Reversion Rights.  This Agreement shall automatically terminate upon the reversion of rights under the APA.

 

(b)           Termination for Economic Non-Viability.  Either Party shall have the right to terminate this Agreement for economic non-viability pursuant to Section 3.3(c) by providing one (1) year prior written notice to the other Party, provided that (i) in no event shall notice of such termination for economic non-viability be given prior to the first (1st) anniversary of the Commercial Launch (as defined in the APA).

 

(c)           Termination for Breach.  Each Party shall be entitled to terminate this Agreement by written notice to the other Party in the event that the other Party shall be in material default or breach of any of its obligations hereunder in any material respect, and shall fail to remedy any such default or breach within sixty (60) days after written notice thereof by the non-defaulting/non-breaching Party.  If such default or breach is not corrected within the foregoing sixty (60) day period, the non-breaching Party shall have the right to terminate this Agreement by giving written notice to the Party in default, provided the notice of termination is given within six (6) months of the default and prior to correction of the default.

 

(d)           Termination upon Bankruptcy.  Either Party may terminate this Agreement if, at any time, the other Party shall file in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for

 

21

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 

[****] INDICATES OMITTED MATERIAL THAT IS 

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 

FILED SEPARATELY WITH THE COMMISSION. 

THE OMITTED MATERIAL HAS BEEN FILED 

SEPARATELY WITH THE COMMISSION.

 

reorganization or for an arrangement or for the appointment of a receiver or trustee of the Party or of its assets, or if the other Party proposes a written agreement of composition or extension of its debts, or if the other Party shall be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed with sixty (60) days after the filing thereof, or if the other Party shall propose or be a Party to any dissolution or liquidation, or if the other Party shall make an assignment for the benefit of creditors.

 

(e)           Termination Due to Safety or Efficacy.  This Agreement will automatically terminate upon written notice by Buyer to Seller in the event that, after  consultation with Seller to the extent practicable under the circumstances, Buyer reasonably determines that there is a safety or efficacy issue with the Product that warrants cessation of sales and marketing of the Product, including in the event that the FDA withdraws its approval of the NDA for the Product for reason of safety or efficacy, and Buyer determines to permanently withdraw the Product from the market throughout the Territory.  Any dispute with respect to any such Buyer determination shall be handled pursuant to Section 8.2.

 

(f)            Termination for Failure to Supply.  Either Party may terminate this Agreement in the event that Seller advises Buyer, pursuant to Section 3.10, that it is unable to remedy the failure to supply situation.

 

7.3          Effect of Termination.

 

(a)           If Seller chooses not to extend this Agreement pursuant to Section 7.1, Seller shall provide two (2) years of Product to Buyer based in the latest Forecast.  In addition, at Buyer’s option, Buyer may acquire the DMF from Seller for five hundred thousand dollars ($500,000) and have Seller provide technology transfer assistance to Buyer or Buyer’s designee with respect to the manufacturing process for the Product at an hourly rate to be agreed between the Parties, provided that in no event shall the number of hours for such technology transfer exceed one hundred (100) hours.  If Buyer chooses to acquire the DMF and have Seller assist with the technology transfer of the manufacturing process, Seller shall transfer such DMF to Buyer as soon as reasonably practicable and provide technology transfer assistance as reasonably requested by Buyer.

 

(b)           If this Agreement is terminated pursuant to Section 7.2(a), 7.2(b), 7.2(e) or by Seller pursuant to Section 7.2(c) or 7.2(d) or if Buyer chooses not to extend this Agreement pursuant to Section 7.1:

 

(i)            the Trademark License and Non-Blocking License shall terminate immediately and Buyer shall cooperate with Seller and take, or cause to be taken, all actions, or to do, or cause to be done, all reasonable things necessary to transfer the Regulatory Approval and Domain Names back to Seller;

 

(ii)           Buyer shall take delivery of and pay for all undelivered Product that is Manufactured pursuant to a Purchase Order, at the Price in effect at the time the Purchase Order was placed provided that Buyer shall be permitted to continue to sell such Product until inventories thereof are exhausted or three months from the date of termination, whichever is earlier; and

 

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CONFIDENTIAL TREATMENT REQUESTED UNDER 
 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 
 [****] INDICATES OMITTED MATERIAL THAT IS 
 THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 
 FILED SEPARATELY WITH THE COMMISSION. 
 THE OMITTED MATERIAL HAS BEEN FILED 
 SEPARATELY WITH THE COMMISSION.

 

(iii)          Buyer shall purchase, at Seller’s book value (as reflected in Seller’s then-current books and records), the materials which were purchased, produced or maintained by Seller in contemplation of filling Purchase Orders within the binding portion of the Forecast prior to notice of termination being given to the extent the same are obsolete or cannot reasonably be used for other products being manufactured by Seller.  Seller shall deliver all such materials to Buyer promptly upon receipt or other control thereof by Seller.

 

(c)           If this Agreement is terminated by Buyer pursuant to Section 7.2(c), 7.2(d) or 7.2(f):

 

(i)            Seller shall grant Buyer a license to its manufacturing know-how for the purpose of manufacturing the Product for sale in the Territory and a right to reference the DMF for such purpose;

 

(ii)           Buyer shall take delivery of and pay for all undelivered Product that is Manufactured pursuant to a Purchase Order, at the Price in effect at the time the Purchase Order was placed provided that Buyer shall be permitted to continue to sell such Product until inventories thereof are exhausted; and

 

(iii)          Buyer shall purchase, at Seller’s book value (as reflected in Seller’s then-current books and records), the materials which were purchased, produced or maintained by Seller in contemplation of filling Purchase Orders within the binding portion of the Forecast prior to notice of termination being given to the extent the same are obsolete or cannot reasonably be used for other products being manufactured by Seller.  Seller shall deliver all such materials to Buyer promptly upon receipt or other control thereof by Seller.

 

(d)           Upon termination of this Agreement for any reason:

 

(i)            Seller will continue to fulfill its remaining obligations pursuant to Sections 4.2 and 4.5; and

 

(ii)           All relevant records and materials in a Receiving Party’s possession or control containing Disclosing Party’s Confidential Information shall be promptly returned to the Disclosing Party.

 

(iii)          The following provisions will survive termination of this Agreement:  Section 2.1(d), Section 7.3, Article VI, Article VIII and Article IX.

 

ARTICLE VIII.
  INDEMNIFICATION, INSURANCE AND DISPUTE RESOLUTION

 

8.1          Indemnification.

 

(a)           Seller Indemnification Obligations.  Seller shall indemnify, defend and hold Buyer, its Affiliates, and its and their officers, directors, agents and employees (individually and/or collectively referred to herein as a “Buyer Party”) harmless from and against any and all losses, liabilities, damages, fees (including reasonable attorneys’ fees), and expenses paid or payable by Buyer or a Buyer Party to a Third Party (collectively, “Buyer

 

23

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 
 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 
 [****] INDICATES OMITTED MATERIAL THAT IS 
 THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 
 FILED SEPARATELY WITH THE COMMISSION. 
 THE OMITTED MATERIAL HAS BEEN FILED 
 SEPARATELY WITH THE COMMISSION.

 

Losses”) to the extent that such Buyer Losses result or arise from a claim, suit or other proceeding made or brought by a Third Party against Buyer or a Buyer Party (a “Buyer Claim”) based on, resulting from, or arising in connection with:

 

(i)            the breach of any material obligation, covenant, agreement, representation or warranty of Seller contained in this Agreement;

 

(ii)           any act or omission by Seller that constitutes recklessness, gross negligence, or willful misconduct on the part of Seller in connection with the performance of its obligations under this Agreement;

 

(iii)          any violation of Applicable Law by Seller in connection with the performance of Seller’s obligations under this Agreement; or

 

(iv)          any infringement or alleged infringement of any Third Party intellectual property right to the extent the claim is based on or arises out of the manufacturing process used by Seller to Manufacture the Product;

 

provided, however, that Seller shall not be obligated to indemnify or hold harmless Buyer or any Buyer Party for any Buyer Claim or Buyer Losses to the extent that such Buyer Claim or Buyer Losses fall within the scope of Buyer’s indemnification obligations in Section 8.1(b), or arise out of or are attributable to any act or omission by Buyer or any Buyer Party which constitutes recklessness, gross negligence or willful misconduct on the part of Buyer or Buyer Party.

 

(b)           Buyer Indemnification Obligations.  Buyer shall indemnify, defend and hold Seller, and its Affiliates, and its and their employees, agents, officers, and directors (individually and/or collectively referred to hereinafter as a “Seller Party”) harmless from and against any and all losses, liabilities, damages, fees (including reasonable attorneys’ fees) and expenses paid or payable by Seller or a Seller Party to a Third Party (collectively, “Seller Losses”) to the extent that such Seller Losses result or arise from a claim, suit or other proceeding made or brought by a Third Party against Seller or a Seller Party (a “Seller Claim”) based on, resulting from, or arising in connection with:

 

(i)            marketing, distribution and sale of the Product;

 

(ii)           the breach of any material obligation, covenant, agreement, representation or warranty of Buyer, or a Buyer Party, contained in this Agreement;

 

(iii)          any act or omission by Buyer that constitutes recklessness, gross negligence, or willful misconduct on the part of Buyer or results from any Buyer’s failure to perform its obligations under this Agreement;

 

(iv)          any violation of Applicable Law by Buyer in connection with the performance of Buyer’s obligations under this Agreement;

 

provided, however, that Buyer shall not be obligated to indemnify or hold harmless Seller or any Seller Party for any Seller Claim or Seller Losses to the extent that such Seller Claim or

 

24

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 
 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 
 [****] INDICATES OMITTED MATERIAL THAT IS 
 THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 
 FILED SEPARATELY WITH THE COMMISSION. 
 THE OMITTED MATERIAL HAS BEEN FILED 
 SEPARATELY WITH THE COMMISSION.

 

Seller Losses fall within the scope of Seller’s indemnification obligations in Section 8.1(a), or arise out of or are attributable to any act or omission by Seller or any Seller Party which constitutes recklessness, gross negligence or willful misconduct on the part of Seller or Seller Party.

 

(c)           Apportionment.  For clarity, in the event that both Parties have indemnification obligations hereunder for a particular claim or loss, the liability for such claim or loss will be allocated proportionately between the Parties in accordance with such Party’s respective fault.

 

(d)           Indemnification Procedures.

 

(i)            Each indemnified Party shall notify the indemnifying Party in writing (and in reasonable detail) of the Claim within ten (10) Business Days after receipt by such indemnified Party of notice of the Seller Claim or Buyer Claim, as the case may be, or otherwise becoming aware of the existence or threatened existence thereof (such Seller Claim or Buyer Claim being referred to as a “Claim”).  Failure to give such notice shall not constitute a defense, in whole or in part, to any claim by an indemnified Party hereunder except to the extent the rights of the indemnifying Party are materially prejudiced by such failure to give notice.  The Indemnifying Party shall notify the indemnified Party of its intentions as to defense of the Claim or potential Claim in writing within ten (10) Business Days after receipt of notice of the Claim.  If the indemnifying Party assumes the defense of a Claim against an indemnified Party, an indemnifying Party shall have no obligation or liability under this ARTICLE VIII as to any Claim for which settlement or compromise of such Claim or an offer of settlement or compromise of such Claim is made by an indemnified Party without the prior written consent of the indemnifying Party, which consent shall not be unreasonably withheld.

 

(ii)           The indemnifying Party shall assume exclusive control of the defense and settlement (including all decisions relating to litigation, defense and appeal) of any such Claim (so long as it has confirmed its indemnification obligation responsibility to such indemnified Party under this Section 8.1(d) with respect to a given Claim); provided, however, that the indemnifying Party may not settle such Claim in any manner that would require payment by the indemnified Party, or would materially adversely affect the rights granted to the indemnified Party hereunder, or would materially conflict with the terms of this Agreement, or adversely affect the Product in or outside the Territory, without first obtaining the indemnified Party’s prior written consent, which consent shall not be unreasonably withheld.

 

(iii)          The indemnified Party shall reasonably cooperate with the indemnifying Party in its defense of the Claim (including, without limitation, making documents and records available for review and copying and making persons within its control available for pertinent testimony in accordance with the confidentiality provisions of ARTICLE VI, and neither Party shall be required to divulge privileged material to the other) at the indemnifying Party’s expense.  If the indemnifying Party assumes defense of the Claim, an indemnified Party may participate in, but not control, the defense of such Claim using attorneys of its choice and at its sole cost and expense, with such cost and expense not being covered by the indemnifying Party.  If an indemnifying Party does not agree to assume the defense of the Claim asserted against the indemnified Party (or does not give notice that it is assuming such

 

25

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 
 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 
 [****] INDICATES OMITTED MATERIAL THAT IS 
 THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 
 FILED SEPARATELY WITH THE COMMISSION. 
 THE OMITTED MATERIAL HAS BEEN FILED 
 SEPARATELY WITH THE COMMISSION.

 

defense), or if the indemnifying Party assumes the defense of the Claim in accordance with Section 8.1(d) yet fails to defend or take other reasonable, timely action, in response to such Claim asserted against the indemnified Party, or in the event that either Party determines on the advice of counsel that a conflict of interest exists between the Parties necessitating separate counsel, the indemnified Party shall have the right to defend or take other reasonable action to defend its interests in such proceedings, and shall have the right to litigate, settle or otherwise dispose of any such Claim; provided, however, that no Party shall have the right to settle a Claim in a manner that would adversely affect the rights granted to the other Party hereunder, or would materially conflict with this Agreement, or would require a payment by the Party, or adversely affect the Product in or outside the Territory, without the prior written consent of the Party entitled to control the defense of such Claim.

 

8.2          Dispute Resolution.  In the event the Parties have a dispute under the terms of this Agreement or any agreement ancillary to this Agreement, the Parties shall follow the following procedure, subject to the rights of either Party to pursue pre-arbitration equitable remedies consistent with Section 9.7:

 

(a)           The Parties will attempt in good faith to resolve any dispute arising out of or relating to this Agreement promptly by negotiation between a representative appointed by Seller, and for Buyer, the President and CEO of Strongbridge Biopharmaceuticals plc or his/her designee.  Any person may give the other Party written notice of any dispute not resolved in the normal course of business.  Within fifteen (15) days after delivery of the notice, the receiving Party will submit to the other a written response.  The notice and response will include (i) a statement of that Party’s position and summary of arguments supporting that position, and (ii) the name and title of the executive who will represent that Party and of any other person who will accompany the executive.  After delivery of the initial notice, the executives of both Parties will meet at a mutually acceptable time and place, and thereafter as often as they reasonably deem necessary, to attempt to resolve the dispute.  All reasonable requests for information made by one Party to the other will be honored.  All negotiations pursuant to this clause are confidential and will be treated as compromise and settlement negotiations for purposes of applicable rules of evidence.  In the event the negotiation between the executives is not successful in resolving the dispute within thirty (30) days after the delivery of the initial notice, the dispute shall be referred to arbitration as described below.

 

(b)           Except as expressly otherwise provided in this Agreement, all disputes arising out of or relating to the interpretation of any provisions of this Agreement or the failure of either Party to perform or comply with any obligation of such Party pursuant to this Agreement or the breach, termination or validity hereof (a “Dispute”), regardless whether such Dispute is based upon a claim or action in contract, warranty, negligence, strict liability or other tort, shall be finally settled by binding arbitration in accordance with the commercial arbitration rules of the American Arbitration Association (“AAA”), then in force and the Federal Arbitration Act, 9 U.S.C. § 1 et seq., by three (3) arbitrators (the “Arbitrators”).  Each Party, within thirty (30) days after the filing of the arbitration demand with the AAA, shall nominate an independent, conflict free arbitrator who shall be appointed in accordance with said rules, provided that the party-appointed arbitrators shall also have appropriate experience in the pharmaceutical industry and may or may not be part of the AAA’s National Roster of arbitrators.  No later than thirty (30) days after the disclosure of the party-appointed arbitrators,

 

26

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 
 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 
 [****] INDICATES OMITTED MATERIAL THAT IS 
 THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 
 FILED SEPARATELY WITH THE COMMISSION. 
 THE OMITTED MATERIAL HAS BEEN FILED 
 SEPARATELY WITH THE COMMISSION.

 

said arbitrators shall meet and select a Chair from a Party-generated list of arbitrators that shall not exceed ten (10) in number and who shall be selected from the AAA National Roster.  The place of arbitration shall be New York, New York, and the Arbitrators shall decide the dispute in accordance with the substantive law of the State of New York.  The Arbitrators, by accepting their appointment, undertake to conduct the process such that the award shall be rendered within six (6) months and in no event later than nine (9) months from the date of the Preliminary Hearing that shall be held by the full arbitral panel within thirty (30) of their final appointment.  The award shall be written and reasoned and shall be final and binding upon all parties participating in such arbitration.  The judgment rendered by the Arbitrators may, at the arbitrator’s discretion, include costs of arbitration, reasonable attorneys’ fees and reasonable costs for any expert and other witnesses.  Judgment upon the award may be entered in any court having jurisdiction, or application may be made to such court for judicial acceptance of the award and/or an order of enforcement as the case may be.  Notwithstanding the foregoing, any Disputes regarding the scope, validity, enforceability or inventorship of any patents or patent applications shall be submitted for final resolution by a court of competent jurisdiction.  Any period of limitations or Survival Period that would otherwise expire between the initiation of the procedures described in this Section 8.2(b) and the conclusion of such procedures shall be extended until twenty (20) days following the conclusion of such procedures.  This Section 8.2(b) shall not prohibit a Party from seeking preliminary injunctive relief in aid of arbitration from a court of competent jurisdiction as set forth in Section 9.7.

 

8.3          Limitation of Liability.  EXCEPT AS EXPRESSLY SET FORTH IN LIABILITY ARISING FROM ARTICLE VI, OR SUCH DAMAGES OWED TO ANY THIRD PARTY AND INDEMNIFIED HEREUNDER PURSUANT TO SECTION 8.1(a) OR SECTION 8.1(b), IN NO EVENT SHALL EITHER PARTY, ITS AFFILIATES, ITS AND THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES, OR AGENTS BE LIABLE TO THE OTHER PARTY FOR ANY LOST PROFITS OR LOST SALE DAMAGES, ANY SPECIAL, INCIDENTAL, INDIRECT, CONSEQUENTIAL OR OTHER SIMILAR DAMAGES, OR ANY PUNITIVE DAMAGES, WHETHER ARISING DIRECTLY OR INDIRECTLY OUT OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT AND REGARDLESS WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER TORT, A PRODUCT CLAIM, OR OTHERWISE ARISING OUT OF OR RELATED TO THIS AGREEMENT.

 

8.4          Insurance.  Each Party hereby represents and warrants to the other Party that during the Term and for five (5) years thereafter, it shall maintain, at its cost, adequate insurance against liability and other risks associated with its activities contemplated by this Agreement, including its indemnification obligations herein, in such amounts and on such terms as are customary for prudent practices in the pharmaceutical industry for the activities to be conducted by it under this Agreement.  Each Party shall furnish to the other Party evidence of such insurance, upon request.

 

27

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 
 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 
 [****] INDICATES OMITTED MATERIAL THAT IS 
 THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 
 FILED SEPARATELY WITH THE COMMISSION. 
 THE OMITTED MATERIAL HAS BEEN FILED 
 SEPARATELY WITH THE COMMISSION.

 

ARTICLE IX.
  MISCELLANEOUS

 

9.1          Assignment.  Neither this Agreement, nor any of the rights or obligations of a Party may be directly or indirectly assigned, sold, delegated or otherwise disposed of without the prior written consent of the other Parties. Notwithstanding the foregoing, either Party may assign this Agreement to an Affiliate, including any successor in interest by way of any reincorporation or other reorganization, and any Party may assign this Agreement to a successor by merger, acquisition, or sale of all or substantially all of such Party’s business assets in the field to which this Agreement relates without the consent of the other Parties, provided that in each case such assigning Party shall provide prompt notification of such assignment the other Party.

 

9.2          Counterparts.  This Agreement may be executed in any number of counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.

 

9.3          Force Majeure.  No liability will result from delay in performance or non-performance under this Agreement, in whole or in part, by either of the Parties to the extent that such delay or non-performance is caused by an event of Force Majeure.  “Force Majeure” means an event that is beyond a non-performing Party’s reasonable control, including an act of God, act of the other Party, strike, lock-out or other industrial/labor dispute, war, acts of war (whether war to be declared or not) riot, insolvency or cessation of operations of a third party supplier, civil commotion, terrorist act, malicious damage, epidemic, quarantine, fire, flood, storm, or natural disaster.

 

9.4          Further Assurances.  Each Party hereto agrees to execute, acknowledge and deliver such further instruments and do all such further acts as may be necessary or appropriate to carry out the purposes and intent of this Agreement.

 

9.5          Modification.  No waiver, alteration or modification of any of the provisions hereof shall be binding unless made in writing and signed by the Parties by their respective officers thereunto duly authorized.

 

9.6          Independent Contractors.  The Parties are independent contractors and this Agreement shall not constitute or give rise to an employer-employee, agency, partnership or joint venture relationship among the Parties and each Party’s performance hereunder is that of a separate, independent entity.

 

9.7          Governing Law; Jurisdiction.  This Agreement shall be governed by and construed in accordance with the laws of the State of New York, United States without regard to its conflicts of laws principles. The Parties consent to the exclusive jurisdiction of the Federal courts and the State courts of the State of New York, in each case, located in the borough of Manhattan, City of New York (the “New York Courts”) for any action in aid of arbitration, for provisional relief of the status quo or to prevent irreparable harm prior to the appointment of the Arbitrators in Section 8.2(b) above, and to the non-exclusive jurisdiction of the New York Courts for any action to enter or enforce any arbitral award entered in connection with this

 

28

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 
 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 
 [****] INDICATES OMITTED MATERIAL THAT IS 
 THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 
 FILED SEPARATELY WITH THE COMMISSION. 
 THE OMITTED MATERIAL HAS BEEN FILED 
 SEPARATELY WITH THE COMMISSION.

 

Agreement.  THE PARTIES HEREBY IRREVOCABLY WAIVE, AND AGREE TO CAUSE THEIR RESPECTIVE AFFILIATES TO WAIVE, THE RIGHT TO TRIAL BY JURY IN SUCH ACTIONS.

 

9.8          Language.  This Agreement, and any amendments or modifications thereto, shall be executed in the English language.  No translation, if any, of this Agreement into any other language shall be of any force or effect in the interpretation of this Agreement or in determination of the intent of either of the Parties hereto.

 

9.9          Article Headings.  The Article headings are placed herein merely as a matter of convenience and shall not affect the construction or interpretation of any of the provisions of this Agreement.

 

9.10        Notices.  Notices required or permitted under this Agreement shall be in writing and sent by prepaid registered or certified air mail or by overnight express mail (e.g., FedEx), or by electronic mail confirmed by electronic mail (including an electronic “read receipt” notice), or by tele-facsimile confirmed by a written act of the receiving Party (e.g., a telefacsimile from the receiving Party submitting its receipt of such notice) and shall be deemed to have been properly served to the addressee (A) upon delivery in the case of prepaid registered or certified air mail or by overnight express mail, or (B) upon receipt of written confirmation in the case of electronic mail or telefacsimile, to the following addresses of the Parties:

 

If to Buyer:

 

Strongbridge Biopharma plc (registered office)

Arthur Cox Building

Earlsfort Terrace

Dublin 2, Ireland

 

With a copy to:

 

Strongbridge Biopharma plc (registered office)

900 Northbrook Drive

Suite 200

Trevose, Pennsylvania 19053

 

If to Seller:

 

Taro Pharmaceuticals North America, Inc.

Harbour Place

103 South Church Street

Grand Cayman KY1-1202

Cayman Islands

Attention:  General Manager

 

29

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 
 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 
 [****] INDICATES OMITTED MATERIAL THAT IS 
 THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 
 FILED SEPARATELY WITH THE COMMISSION. 
 THE OMITTED MATERIAL HAS BEEN FILED 
 SEPARATELY WITH THE COMMISSION.

 

With a copy to:

 

Taro Pharmaceuticals USA, Inc.

3 Skyline Drive

Hawthorne, NY 10532

Attention:  General Counsel

 

9.11        Third Parties.  None of the provisions of this Agreement shall be for the benefit of or enforceable by any Third Party.

 

9.12        Waiver.  The waiver by either Party of a breach or a default of any provision of this Agreement by the other Party shall not be construed as a waiver of any succeeding breach of the same or any other provision, nor shall any delay or omission on the part of either Party to exercise or avail itself of any right, power or privilege that it has or may have hereunder operate as a waiver of any right, power or privilege by such Party.

 

9.13        Severability.  If any part of this Agreement is declared invalid by any legally governing authority having jurisdiction over either Party, then such declaration shall not affect the remainder of the Agreement and the Parties shall revise the invalidated part in a manner that will render such provision valid without impairing the Parties’ original intent.

 

9.14        Entire Agreement.  This Agreement and the APA (including the ancillary agreements referenced therein) constitute the entire agreement between the Parties relating to the subject matter hereof and supersedes all previous writings and understandings, whether written or oral, with respect to the subject matter hereof.

 

9.15        Conflict.  In the event of a conflict between the APA and this Agreement, the terms of the APA shall control, except that in connection with the terms relating to the manufacture of the Product by Seller, this Agreement shall control.  In the event of a conflict between this Agreement, the Quality Agreement or the Pharmacovigilance Agreement, this Agreement shall control, unless: (i) the conflict is between the Quality Agreement and this Agreement and the term at issue pertains to the quality manufacture of the Product, in such case, the Quality Agreement shall control; or (ii) the conflict is between the Pharmacovigilance Agreement and this Agreement and the term at issue pertains the exchange of safety data information relating to the Product, in such case, the Pharmacovigilance Agreement shall control.  In the event of a conflict between the Quality Agreement and the Pharmacovigilance Agreement, the Quality Agreement shall control unless the term at issue pertains to the exchange of safety data information relating to the Product, in which case, the Pharmacovigilance Agreement shall control.

 

9.16        Drafting Ambiguities.  Each Party to this Agreement and its counsel have reviewed and revised this Agreement.  The 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 or any amendment, Exhibit or Schedule to this Agreement.

 

30

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 
 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 
 [****] INDICATES OMITTED MATERIAL THAT IS 
 THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 
 FILED SEPARATELY WITH THE COMMISSION. 
 THE OMITTED MATERIAL HAS BEEN FILED 
 SEPARATELY WITH THE COMMISSION.

 

9.17        International Sale of Goods Act.  The Parties acknowledge and agree that the International Sale of Goods Act and the United Nations Convention on Contracts for the International Sale of Goods have no application to this Agreement.

 

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

 

31

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 
 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 
 [****] INDICATES OMITTED MATERIAL THAT IS 
 THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 
 FILED SEPARATELY WITH THE COMMISSION. 
 THE OMITTED MATERIAL HAS BEEN FILED 
 SEPARATELY WITH THE COMMISSION.

 

IN WITNESS WHEREOF, the Parties hereto have caused this Supply Agreement to be executed as of the Effective Date by their duly authorized representatives.

 

	
 
    	
TARO PHARMACEUTICALS NORTH   AMERICA, INC.
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/ Paul Woodhouse
    
	
 
    	
 
    	
 
    
	
 
    	
Name:
    	
Paul Woodhouse
    
	
 
    	
 
    	
 
    
	
 
    	
Title:
    	
Vice President, General   Manager
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
STRONGBRIDGE BIOPHARMA PLC
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/ Matthew Pauls
    
	
 
    	
 
    	
 
    
	
 
    	
Name:
    	
Matthew Pauls
    
	
 
    	
 
    	
 
    
	
 
    	
Title:
    	
President and CEO
    

 

Supply Agreement

Signature Page

 

32

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 
 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 
 [****] INDICATES OMITTED MATERIAL THAT IS 
 THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 
 FILED SEPARATELY WITH THE COMMISSION. 
 THE OMITTED MATERIAL HAS BEEN FILED 
 SEPARATELY WITH THE COMMISSION.

 

SCHEDULE 2.1(A)

 

TRANSFER PRICE

 

Transfer Price:  $[****] per Unit of Product.

 

The Transfer Price shall be firm for the first year of the Term. Thereafter, on an annual basis, the Transfer Price is subject to adjustment by [****] percent ([****]%).  Any such adjustment will be effective for the entire subsequent twelve (12) month period of the applicable Term.

 

33

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 
 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 
 [****] INDICATES OMITTED MATERIAL THAT IS 
 THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 
 FILED SEPARATELY WITH THE COMMISSION. 
 THE OMITTED MATERIAL HAS BEEN FILED 
 SEPARATELY WITH THE COMMISSION.

 

SCHEDULE 3.1

 

PRODUCT SUPPLY DETAILS

 

Minimum Remaining Shelf Life at the time of Delivery: not less than the current approved Product shelf life less four (4) months.

 

34

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 
 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 
 [****] INDICATES OMITTED MATERIAL THAT IS 
 THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 
 FILED SEPARATELY WITH THE COMMISSION. 
 THE OMITTED MATERIAL HAS BEEN FILED 
 SEPARATELY WITH THE COMMISSION.

 

SCHEDULE 3.3

 

DELIVERY SCHEDULE FOR 
 MINIMUM ORDER QUANTITIES

 

35

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 
 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 
 [****] INDICATES OMITTED MATERIAL THAT IS 
 THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 
 FILED SEPARATELY WITH THE COMMISSION. 
 THE OMITTED MATERIAL HAS BEEN FILED 
 SEPARATELY WITH THE COMMISSION.

 

SCHEDULE 3.6

 

PROCEDURE FOR LABELING CHANGE

 

If Strongbridge Changing:

 

1. Taro provides files to Strongbridge to review and make DRAFT revisions

2. Taro receives artwork and Regulatory Reviews

3. Taro Regulatory responds with any further correction or revision requests depending on Strongbridge alterations

4.  If no change request, routing within Taro internal artwork system is initiated within Production, Marketing and further Regulatory

5.  If change requested, than first step is visited above and process continues through each point until agreed and approved

6.  Artwork then FTP’d and routed to vendor for print

 

If Taro Changes:

 

1. Taro graphics team seeks graphics material from Strongbridge (text or branding requirements)

2. Taro graphics team makes proper DRAFT revisions

3. Taro Regulatory Reviews for any corrections or further revision needs

4. Taro sends artwork for Strongbridge to review for comment

5.  If no change request, routing within Taro internal artwork system is initiated within Production, Marketing and further Regulatory

6.  If change request from Strongbridge, than step 2 is visited above and process continues through each point until agreed and approved

7.  Artwork then FTP’d and routed to vendor for print

 

36

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 
 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 
 [****] INDICATES OMITTED MATERIAL THAT IS 
 THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 
 FILED SEPARATELY WITH THE COMMISSION. 
 THE OMITTED MATERIAL HAS BEEN FILED 
 SEPARATELY WITH THE COMMISSION.

 

EXHIBIT A

 

QUALITY AGREEMENT

 

[TO BE ATTACHED]

 

37

 

CONFIDENTIAL TREATMENT REQUESTED UNDER 
 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. 
 [****] INDICATES OMITTED MATERIAL THAT IS 
 THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST 
 FILED SEPARATELY WITH THE COMMISSION. 
 THE OMITTED MATERIAL HAS BEEN FILED 
 SEPARATELY WITH THE COMMISSION.

 

EXHIBIT B

 

PHARMACOVIGILANCE AGREEMENT

 

[TO BE ATTACHED]

 

38

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