UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

 

FORM 20-F/A

(Amendment No. 1)

 

 

 

¨ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934

 

OR

 

x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the fiscal year ended    December 31, 2017

 

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from                      to                  

 

OR

 

¨ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

Date of event requiring this shell company report                 

 

Commission file number:        000-29338        

 

 

 

CORREVIO PHARMA CORP.

(Exact name of Registrant as specified in its charter)

 

 

 

Not Applicable

(Translation of Registrant’s name into English)

 

Canada

(Jurisdiction of incorporation or organization)

 

1441 Creekside Drive, 6th Floor,

Vancouver, British Columbia,

Canada, V6J 4S7

(Address of principal executive offices)

 

 

 

Justin Renz, Chief Financial Officer

Tel: (604) 677-6905

1441 Creekside Drive, 6th Floor,

Vancouver, British Columbia,

Canada, V6J 4S7

(Name, Telephone, E-mail, and/or Facsimile number and Address of Company Contact Person)

 

Securities registered or to be registered pursuant to Section 12(b) of the Act:

 

Title of Each Class   Name of each exchange on which registered
Common Shares   Nasdaq Stock Market

 

Securities registered or to be registered pursuant to Section 12(g) of the Act: None

 

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None

 

 

 

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report: 

 

The Registrant had 34,637,312 Common Shares outstanding as at December 31, 2017.

 

Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act     Yes   ¨     No   x

 

If this report is an annual or transition report, indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.     Yes   ¨     No   x

 

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Sections 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes   x    No   ¨

 

Indicate by check mark whether the Registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such period that the Registrant was required to submit and post such files).     Yes   x     No   ¨

 

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated Filer  ¨ Accelerated Filer  x Non-accelerated Filer  ¨ Emerging Growth Company ¨

 

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. ¨   

 

† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

 

Indicate by check mark which basis of accounting the Registrant has used to prepare the financial statements included in this filing:

 

U.S. GAAP  x International Financial Reporting Standards as issued by the International Accounting Standards Board   ¨ Other  ¨

 

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the Registrant has elected to follow:    Item 17  ¨     Item 18  ¨

 

If this is an annual report, indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes    ¨    No    x

 

   

 

 

EXPLANATORY NOTE

 

This Amendment No. 1 on Form 20-F/A (this “Amendment”) amends the Annual Report on Form 20-F for the year ended December 31, 2017 of Correvio Pharma Corp. (the “Company”), as originally filed with the U.S. Securities and Exchange Commission on April 30, 2018 (the “Original Form 20-F”). The Company is filing this Amendment solely to file Exhibits 4.1, 4.2, 4.3, 4.4, 4.5 and 4.6.

 

Effective May 15, 2018, Cardiome Pharma Corp. (“Cardiome”) and the Company completed a court-approved statutory plan of arrangement (the “Arrangement”) under the Canada Business Corporations Act . Under the Arrangement each holder of common shares of Cardiome received one common share of the Registrant.

 

Other than as required to reflect the amendments discussed above, this Amendment does not, and does not purport to, amend, update or restate any other information in the Original Form 20-F, or reflect any events that have occurred after the filing of the Original Form 20-F. 

 

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PART III

 

ITEM 19. EXHIBITS

 

1.1 Certificate and Articles of Amalgamation of Cardiome Pharma Corp., dated March 1, 2009 and Certificate of Amendment of Cardiome Pharma Corp. dated April 9, 2013. **
   
1.2 By-Law No.1 of Cardiome Pharma Corp., as amended. **
   
4.1 Distribution Agreement between Correvio International Sarl and Basilea entered into on September 11, 2017.†
   
4.2 Amended and Restated Term Loan Agreement between Cardiome Pharma Corp. and CRG entered into on May 11, 2017.
   
4.3 License Agreement by and between Correvio International Sarl and Durata Therapeutics International B.V. (Allergan) entered into on May 5, 2016.†
   
4.4 Supply Agreement by and between Correvio International Sarl and Durata Therapeutics International B.V. (Allergan) entered into on May 5, 2016.†
   
4.5 Exclusive License and Supply Agreement by and between Cardiome Pharma Corp., Correvio International Sarl and SteadyMed entered into on June 28, 2015.†
   
4.6 Arrangement Agreement between Cipher Pharmaceuticals Inc. and Cardiome Pharma Corp. and Correvio Pharma Corp. entered into on March 19, 2018.
   
8.1 List of Subsidiaries. **
   
12.1 Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) of the Securities and Exchange Act of 1934, as amended. **
   
12.2 Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) of the Securities and Exchange Act of 1934, as amended. **
   
13.1 Certification by the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as added by Section 906 of the Sarbanes – Oxley Act of 2002. **
   
15.1 Consent of KPMG LLP. **
   
101 Interactive Data File. **

 

 

** Previously filed.

 

Confidential portions of this exhibit have been redacted and filed separately with the Securities and Exchange Commission pursuant to a  confidential treatment  request in accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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SIGNATURES

 

The Registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this Amendment No. 1 to the annual report on Form 20-F on its behalf.

 

  CORREVIO PHARMA CORP.
DATED: July 12, 2018    
     
  By: /s/ Justin Renz
    Justin Renz
    Chief Financial Officer

 

 

 

 

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EXHIBIT INDEX

 

1.1 Certificate and Articles of Amalgamation of Cardiome Pharma Corp., dated March 1, 2009 and Certificate of Amendment of Cardiome Pharma Corp. dated April 9, 2013. **
   
1.2 By-Law No.1 of Cardiome Pharma Corp., as amended. **
   
4.1 Distribution Agreement between Correvio International Sarl and Basilea entered into on September 11, 2017.†
   
4.2 Amended and Restated Term Loan Agreement between Cardiome Pharma Corp. and CRG entered into on May 11, 2017.
   
4.3 License Agreement by and between Correvio International Sarl and Durata Therapeutics International B.V. (Allergan) entered into on May 5, 2016.†
   
4.4 Supply Agreement by and between Correvio International Sarl and Durata Therapeutics International B.V. (Allergan) entered into on May 5, 2016.†
   
4.5 Exclusive License and Supply Agreement by and between Cardiome Pharma Corp., Correvio International Sarl and SteadyMed entered into on June 28, 2015.†
   
4.6 Arrangement Agreement between Cipher Pharmaceuticals Inc. and Cardiome Pharma Corp. and Correvio Pharma Corp. entered into on March 19, 2018.
   
8.1 List of Subsidiaries. **
   
12.1 Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) of the Securities and Exchange Act of 1934, as amended. **
   
12.2 Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) of the Securities and Exchange Act of 1934, as amended. **
   
13.1 Certification by the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as added by Section 906 of the Sarbanes – Oxley Act of 2002. **
   
15.1 Consent of KPMG LLP. **
   
101 Interactive Data File. **

 

 

** Previously filed.

 

Confidential portions of this exhibit have been redacted and filed separately with the Securities and Exchange Commission pursuant to a  confidential treatment  request in accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Exhibit 4.1

 

CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
[…***…] 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

 

DISTRIBUTION AGREEMENT

 

BETWEEN

 

CORREVIO INTERNATIONAL SARL

 

AND

 

BASILEA PHARMACEUTICA INTERNATIONAL LTD.

 

Dated as of September 11, 2017

 

 

CONFIDENTIAL

 

TABLE OF CONTENTS

 

ARTICLE 1 DEFINITIONS 1
ARTICLE 2 APPOINTMENT AND PARTIES’ GENERAL CONDUCT 10
ARTICLE 3 COMMERCIALIZATION 15
ARTICLE 4 REGULATORY MATTERS AND PHARMACOVIGILANCE 16
ARTICLE 5 SUPPLY OF PRODUCT 22
ARTICLE 6 MANUFACTURING STANDARDS AND QUALITY ASSURANCE 25
ARTICLE 7 ASSUMED AND ACTUAL TRANSFER PRICE; PAYMENT TERMS 29
ARTICLE 8 EXECUTION PAYMENT; REGULATORY PAYMENTS; MILESTONE PAYMENTS 32
ARTICLE 9 REPRESENTATIONS AND WARRANTIES 32
ARTICLE 10 INTELLECTUAL PROPERTY 36
ARTICLE 11 INDEMNIFICATION AND LIABILITY 38
ARTICLE 12 INSURANCE 39
ARTICLE 13 CONFIDENTIAL INFORMATION 40
ARTICLE 14 TERM; TERMINATION 42
ARTICLE 15 RECORDS AND AUDITS 44
ARTICLE 16 NOTICES 44
ARTICLE 17 MISCELLANEOUS 45
SCHEDULE 1  
SCHEDULE 2  
SCHEDULE 3  
SCHEDULE 4  
SCHEDULE 5  
SCHEDULE 6  
SCHEDULE 7  
SCHEDULE 8  
SCHEDULE 9  

 

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CONFIDENTIAL

 

DISTRIBUTION AGREEMENT

 

THIS DISTRIBUTION AGREEMENT dated as of September 11, 2017 (the “Effective Date”) is made by and between Correvio International Sàrl, a corporation organized and existing under the laws of Switzerland with offices at Rue des Alpes 21, Case postale 1674, 1201 Geneva, Switzerland (hereinafter “Cardiome”), and Basilea Pharmaceutica International Ltd., a corporation organized and existing under the laws of Switzerland, with offices at Grenzacherstrasse 487, CH-4058, Basel, Switzerland (hereinafter “Basilea”). Cardiome and Basilea may be referred to herein individually as a “Party” or collectively as the “Parties.”

 

WITNESSETH:

 

WHEREAS, Basilea owns and/or has the exclusive right to certain technology, intellectual property rights and confidential and/or proprietary information relating to the Product;

 

WHEREAS, Basilea is engaged in the research, development, manufacturing and commercialization of pharmaceutical products and has been granted Marketing Authorisation of the Product in certain countries of the Territory;

 

WHEREAS, Cardiome is engaged in the registration, promotion and commercialization of pharmaceutical products in the Territory;

 

WHEREAS, Basilea wishes to grant Cardiome an exclusive license to commercialize the Product in the Territory, and Cardiome wishes to accept such license, subject to the terms and conditions of this Agreement;

 

NOW, THEREFORE, in consideration of these premises and the covenants and agreements set forth herein, and intending to be legally bound thereby, the Parties hereby agree as follows:

 

ARTICLE 1 DEFINITIONS

 

As used in this Agreement, the following terms shall have the meanings set forth below.

 

1.1 “Actual Transfer Price” means the price in Swiss Francs payable by Cardiome for each Bulk Vial of the Product determined in accordance with Article 7.

 

1.2 “Affiliate(s)” means, with respect to each Party, any corporation, firm, partnership or other entity or Person which directly or indirectly controls or is controlled by or is under common control with that Party. For purposes of this definition, “control” (including, with correlative meaning, the terms “controlled by” and “under common control with”) shall be presumed to exist if one of the following conditions is met: (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors of such corporate entity or any direct or indirect parent of such corporate entity, and (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the power to direct the management and policies of such non-corporate entities.

 

 

CONFIDENTIAL

 

1.3 “Agreement” means this Distribution Agreement and all Schedules hereto as the same may be amended, supplemented or otherwise modified from time to time.

 

1.4 “Applicable Law” means (i) any applicable statute, statutory instrument or any other legislative instrument having the force of law; (ii) any applicable judgment of a relevant court of law which is binding precedent in any applicable jurisdiction, in each case in force at any time during the Term; and (iii) all applicable guidance, directions, codes of practice, self-regulation, determination, regulations or professional standards either issued by a Regulatory Authority or applicable to the relevant activity.

 

1.5 “Assumed Transfer Price” means the assumed transfer price in Swiss Francs for each Bulk Vial of the Product determined in accordance with Article 7.

 

1.6 “Authorisation” means all applicable licenses, registrations and governmental approvals and permits that may be necessary to permit the importation, transportation, distribution, Manufacturing and the Selling of the Product in the Territory, including the marketing authorisation and any necessary pricing, reimbursement and formulary listing applications, as such licenses, registrations, approvals or permits are granted by the applicable Regulatory Authority and other authorities in the Territory.

 

1.7 “Basilea Core Materials” shall have the meaning set forth in Section 3.6(a).

 

1.8 “Basilea Indemnitees” shall have the meaning set forth in Section 11.1.

 

1.9 “Basilea Information” means information owned or Controlled by Basilea, in whatever format recorded, including the Dossier and the Know-how, which relates to the Product, including but not limited to (i) information relating to the manufacture of the Product including information relating to contract manufacturers and the manufacturing supply chain of the Product, including API (active pharmaceutical ingredient), fill finish, packaging; (ii) information relating to the pricing and reimbursement of the Product outside the Territory; (iii) information relating to the Commercialization of the Product outside the Territory, including advertising and promotional strategies; (iv) information relating to the competitive positioning of the Product, including market research reports; (v) information relating to the Intellectual Property protecting the Product, including Patents, Trade Marks and inventions on which patent applications have not been filed; (vi) distribution information (including storage recommendations); (vii) pharmacovigilance data, and any other information relating to the Commercialization of the Product which is not generally ascertainable.

 

1.10 “Basilea IP” means the Know-How, the Trademarks, the Domains, and the Patents.

 

1.11 “Bulk Vial” means Finished Product excluding secondary packaging.

 

1.12 “Business Day” means any day other than Saturday, Sunday or any day on which banks located in Switzerland are authorized or obligated to be closed.

 

1.13 “Cardiome Core Materials” shall have the meaning set forth in Section 3.6(b).

 

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CONFIDENTIAL

 

1.14 “Cardiome Indemnitees” shall have the meaning set forth in Section 11.1(b).

 

1.15 “Claim or Proceeding” means any claim, action, suit, proceeding or arbitration including any Governmental Authority action, notification, investigation or audit.

 

1.16 “Clawback/Payback” has the following meanings: (a) Clawback means a mandatory reimbursement system unilaterally imposed on Cardiome by a competent Regulatory Authority allowing a Third Party to recoup from Cardiome all or part of the discounts/rebates granted on sales of Products; (b) Payback means a mandatory financial mechanism unilaterally imposed on Cardiome by a competent Regulatory Authority that requires Cardiome to refund revenues if Cardiome’s sales of Product exceed a previously determined or agreed target-budget.

 

1.17 “Clawback/Payback/Managed Entry Requirements Report” has the meaning set forth in Section 7.7(a).

 

1.18 “Commercialization” or “Commercialize” means all activities directed to importing, transporting, distributing, warehousing, advertising, marketing, promoting, selling or otherwise using the Product in the Territory.

 

1.19 “Commercialization Plan(s)” means the commercialization plan(s) to be prepared by Cardiome pursuant to Section 3.1 and the template provided in Schedule 1.

 

1.20 “Commercial Launch Plan” means the plan providing the estimated timeline for the registration of the Product (in countries in the Territory where the Product is not yet registered) and for the First Commercial Sale Date by Cardiome of the Product, the template for which is set out in Schedule 4.

 

1.21 “Commercially Reasonable Endeavours” means efforts that are comparable to those used by the pharmaceutical industry, and are financially reasonable in the relevant region or in the Territory for products that have a similar commercial potential and are at similar stages in the product life cycle measured by the facts and circumstances including present and future market potential, medical and clinical considerations, present and future regulatory environment and competitive market conditions.

 

1.22 “Confidential Information” has the meaning defined in Article 13.

 

1.23 “Control” means, with respect to any information, patent, know-how, trade mark or other intellectual property right, possession by a Party of the ability to grant the right to access or use, or to grant a license or a sublicense to, such information, patent, know-how, trade mark or other intellectual property right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party and “Controlled” shall have a correlative meaning.

 

1.24 “Core European Territory” means Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Switzerland, the United Kingdom of Great Britain, and Northern Ireland.

 

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CONFIDENTIAL

 

1.25 “Current Good Manufacturing Practices” or “cGMP” mean all applicable standards and Applicable Law relating to manufacturing practices for products (including ingredients, testing, storage, handling, intermediates, bulk and finished products) promulgated by the United States Food and Drug Administration or any other Governmental Authority (including, without limitation, EU or member state level) , including but not limited to standards in the form of laws, guidelines, advisory opinions and compliance policy guides and current interpretations of the applicable authority or agency thereof (as applicable to pharmaceuticals, biologicals and over the counter products and ingredients), as the same may be updated, supplemented or amended from time to time.

 

1.26 “Customer(s)” means any Third Party administering or prescribing the Product.

 

1.27 “Deduction Cap” shall have the meaning provided in Section 1.57.

 

1.28 “Delivery” has the meaning provided in Section 5.2, and “Deliveries”, “Delivers” or “Delivered” have the corresponding meaning.

 

1.29 “Details” means the communication by a sales representative during a personal visit to a member of the target prescriber audience (a) involving face-to-face contact at the target prescriber’s place of work, (b) describing in a fair and balanced manner the relevant characteristics of the Product, and (c) using the Basilea Core Materials and/or the Cardiome Core Materials in an effort to increase the prescribing preferences of the Product.

 

1.30 “Domains” mean the domains set out in Schedule 3 and any other domains dedicated for the Product owned or Controlled by Basilea, which may be used in Commercialization of the Product in the Territory.

 

1.31 “Dossier” means the harmonized registration files relating to the Product in electronic common technical document (eCTD) format prepared by or on behalf of Basilea or its Affiliates in the form used for the decentralized registration procedure in the European Union and subsequent Mutual Recognition Processes/Repeat-Use Procedures related to the Product, as such harmonized registration files may be amended from time to time.

 

1.32 “Drug Substance” means the active pharmaceutical ingredient of the Product ceftobiprole medocaril (BAL 5788)

 

1.33 “Effective Date” shall have the meaning set forth in the preamble above.

 

1.34 “European Union PIP” means activities and studies relating to the paediatric investigation plan for the Product required by the Regulatory Authority(ies) in the European Territory, together with any amendments and updates required by such Regulatory Authority(ies) from time to time.

 

1.35 “Execution Payment” shall have the meaning set forth in Section 8.1.

 

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CONFIDENTIAL

 

1.36 “Facility” means the facility or facilities owned and operated by Contract Manufacturing Organizations (CMOs) specified in the Dossier (as amended from time to time) and used by Basilea to manufacture, store, or package the Product hereunder.

 

1.37 “Field” means the treatment, prevention, diagnosis, control and maintenance of all diseases and disorders in humans.

 

1.38 “Finished Product” means Qualified Person Released Product in its final market form (vials) after packaging and labeling in accordance with the Specifications to be distributed in the Territory.

 

1.39 “First Commercial Sale Date” means each date of the first commercial sale of Finished Product to Customer by or on behalf of Cardiome in each country of the Territory.

 

1.40 “First Commercial Supply Date” means the first date on which Basilea first supplies Finished Product to Cardiome (with the exception of the Inventory).

 

1.41 “Force Majeure Event” shall have the meaning set forth in Section 17.5.

 

1.42 “Forms” shall mean a purchase order acknowledgment form or similar routine document as specified in Section 17.9.

 

1.43 “GDP” means the Good Distribution Practice as specified in Articles 76 to 85 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 and the guidelines for Good Distribution Practice as promulgated in “Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use” (2013/C 343/01), as amended from time to time.

 

1.44 “Government” means all levels and subdivisions of any relevant government (i.e., local, regional, or national and administrative, legislative, or executive).

 

1.45 “Governmental Authority” means any duly authorized court, tribunal, arbitrator, agency, commission, official or other instrumentality of any federal, state, province, county, city or other political subdivision, domestic or foreign.

 

1.46 “Insolvent Party” shall have the meaning set forth in Section 14.3.

 

1.47 “Intellectual Property” means (a) any processes, trade secrets, inventions, industrial models, designs, methodologies, drawings, formulae, procedures, techniques, clinical data or technical or other information or data, manufacturing, engineering and technical drawings necessary or useful in the registration, packaging, manufacture, use or sale of the Product, and (b) registered trade marks, trade mark applications, unregistered trade marks, trade dress, copyrights, know-how, Patents covering the Product or any components thereof or improvements thereof, in both (a) and (b) as owned or Controlled by Basilea.

 

1.48 “Inventory” shall have the meaning set forth in Section 2.10.

 

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CONFIDENTIAL

 

1.49 “Know-how” means all existing or future proprietary unpatented information, owned or Controlled by Basilea relating to the Product including but not limited to ideas, processes, trade secrets, inventions, industrial models, designs, methodologies, drawings, formulae, procedures, techniques, records, clinical data or technical or other information or data, manufacturing, engineering and technical drawings and other information which is necessary for obtaining and maintaining the Marketing Authorisation or which is useful in the research, development, registration, packaging, manufacture, use or sale of the Product and all data contained in the Dossier and other relevant pharmacological, toxicological, metabolic, non-clinical and clinical data.

 

1.50 “Latent Defect” means a defect to the Product already present at the time of Delivery of the Product to Cardiome but not detected despite inspection by Cardiome or any of its Affiliates in accordance with this Agreement.

 

1.51 “Losses” means any and all losses, damages, liabilities, costs and expenses (including legal fees and expenses).

 

1.52 “Minimum Order Quantities” shall be the minimum amounts of Product which may be ordered in each Purchase Order as listed in Schedule 6.

 

1.53 “Minimum Transfer Price” shall be [...***...] per Bulk Vial of Product.

 

1.54 “Marketing Authorisation” means such formal approval from a Regulatory Authority as is necessary for the commercial marketing, sale, and use of pharmaceutical products within a country of the Territory (but excluding Pricing and Reimbursement Approval).

 

1.55 “Marketing Authorisation Application” means an application to the appropriate Regulatory Authority for Marketing Authorisation for the Product in any particular jurisdiction and all amendments and supplements thereto.

 

1.56 “National Marketing Authorisation” means the approval from a Regulatory Authority in the EU on a national level for the Product based upon a Mutual Recognition Processes/Repeat-Use Procedure under the Dossier.

 

1.57 “Net Sales” shall mean the gross amounts (excluding VAT or other similar taxes) invoiced by or on behalf of Cardiome, its Affiliates and/or Sublicensees (the “Selling Party”) for sales of the Product to Third Parties (other than Sublicensees), less the following deductions, paid and specifically related to the Product by Cardiome, its Affiliates and/or Sublicensees using U.S. GAAP applied on a consistent basis:

 

(a) […***…];

 

(b) […***…];

 

(c) […***…]; and

 

(d) […***…].

 

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CONFIDENTIAL

 

In no event shall any particular amount identified above be deducted more than once in calculating Net Sales (i.e., no “double counting” of reductions). Sales of the Product between Cardiome and its Affiliates and/or Third Party Sublicensees and/or Third Party Distributors for resale shall be excluded from the computation of Net Sales, but the subsequent resale of the Product by an Affiliate or Sublicensee, as applicable, to a Third Party shall be included within the computation of Net Sales.

 

Notwithstanding anything to the contrary herein, Cardiome’s disposal or use of the Product for regulatory, Development or charitable purposes when such disposal or use is not a sale (meaning that Cardiome receives no benefit either in cash or in kind for such disposal or use and issues no invoice related to such disposal or use), such as clinical trials, preclinical trials, compassionate use, named patient use, or indigent patient programs, without consideration, shall not be deemed a sale for the purposes of computation of the Net Sales clause. All supply for such purposes shall be purchased by Cardiome from Basilea at the Minimum Purchase Price pursuant to Section 7.3.

 

In no event shall the deductions provided in paragraph d) exceed a total of [...***...] of the gross revenues (the “Deduction Cap”).

 

For the avoidance of doubt, Clawback/Payback/ Managed Entry Requirements shall follow the terms set forth in Section 7.7(a) and are not permissible deductions from Net Sales.

 

For all deductions listed above, to the extent that Cardiome sells a grouped set of products in which the Product is included, the applicable discount, allowance, rebates and other deductions for the Product in such arrangement for purposes of calculating Net Sales shall be the average discount, allowance, rebate or other deductions for the group set of products (as compared to the non-discounted prices of the respective products when sold separately) multiplied by the fraction X/(X + Y), where X = the average discount, allowance, rebate or other deductions of the Product when sold separately (in percentage) and Y = the average discount, allowance, rebate or other deductions of other products in the group when sold separately (in percentage). An example of such calculation is attached to this Agreement in Schedule 7.

 

1.58 “Non-EU Eastern European Territory” means Albania, Bosnia and Herzegovina, Israel, Macedonia, Montenegro, San Marino, and Serbia.

 

1.59 “Patents” means the patents and patent applications, including patent extensions, provisional applications, divisions, continuations, continuations in part, substitutions, renewals, registrations, revalidations, reissues or additions, supplementary protection certificates, and applications and all foreign counterparts thereof, or any future patents or patent applications, owned and/or Controlled by Basilea or its Affiliates covering the Product, its manufacture or use, including the patents as listed in Schedule 2.

 

1.60 “Person” means any natural person, entity, corporation, general partnership, limited partnership, proprietorship, other business organization, trust, union, association or Governmental Authority.

 

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CONFIDENTIAL

 

1.61 “Product” means any formulations and pharmaceutical dosage forms of ceftobiprole medocaril.

 

1.62 “Purchase Order” means a written or electronic order form submitted by Cardiome to Basilea for the purchase and supply of Product in accordance with the terms of this Agreement.

 

1.63 “Qualified Person” has the meaning provided in the Quality Agreement.

 

1.64 “Qualified Person Release” has the meaning provided in Section 5.2 and further specified in the Quality Agreement and “Qualified Person Released” has the correlative meaning.

 

1.65 “Quality Agreements” means those supplemental quality provisions set forth in agreements between Basilea and Cardiome relating to the Product which will be agreed after the Effective Date in accordance with Section 6.1.

 

1.66 “Recall” means a recall, correction or market withdrawal and shall include any post-sale warning or mailing of information.

 

1.67 “Records” means any books, documents, accounting procedures and practices and other data, regardless of type or form, of all matters relating each Party’s performance of its obligations under this Agreement that enable that Party to demonstrate compliance with such obligations, including, without limitation, its compliance with Applicable Law.

 

1.68 “Regulatory Authority” means anybody having regulatory authority over any part of Basilea’s or Cardiome’s business or the activities contemplated under this Agreement, in whatever jurisdiction.

 

1.69 “Repeat-use Procedure” means the process for submission of an application for a National Marketing Authorisation in an EU member state based upon a granted Marketing Authorization in another EU member state.

 

1.70 “Safety Data Exchange Agreement” shall have the meaning set forth in Section 4.4.

 

1.71 “Selling Party” shall have the meaning set forth in Section 1.57.

 

1.72 “Specifications” means the specifications for the manufacture, processing, packaging, labeling, testing and testing procedures, shipping, storage and supply of the Product, including all formulae, know-how, raw materials requirements, analytical procedures and standards of quality control, quality assurance and sanitation, attached to the Quality Agreement.

 

1.73 “Submission” means a submission by or on behalf of either Party or its Affiliates to a Regulatory Authority with respect to the Product, which may include, but shall not be limited to, submissions with respect to the Product for variations, notifications, renewals, PSUR, labeling and artwork.

 

1.74 “Term” shall have the meaning set forth in Section 14.1.

 

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1.75 “Territory” means the Core European Territory and the Non-EU Eastern European Territory.

 

1.76 “Tests” means any quantitative structure activity relationship (QSAR) analysis and any in vitro and in vivo testing of impurities and degradants in the Product, Product substance, Product substance intermediates and raw materials for the purpose of structural identification and/or toxicological categorization and/or toxicological qualification in accordance with ICH M7. For the avoidance of doubt, Tests does not mean any standard analytical quality controls related to supplied Product.

 

1.77 “Third Party” means any Person other than Cardiome, Basilea and their respective Affiliates.

 

1.78 “Third Party Distributor” means any Third Party supporting Cardiome or any of its Affiliates with the provision of local Product distribution services or Commercialization of the Product in any country of the Territory. For the avoidance of doubt, Wholesalers and logistic service providers are not Third Party Distributors.

 

1.79 “Third Party Licensee” means any Third Party which is granted a sublicense by Cardiome in accordance with Section 2.1(b).

 

1.80 “Trade Marks” shall mean the trade marks set out in Schedule 3 and any other trademarks and/or logos and/or trade dress of the Product owned or Controlled by Basilea, which will be used in Commercialization the Product in the Territory.

 

1.81 “Transition Period” and “Initial Transition Period” have the meaning given to them in the Transitional Services Agreement.

 

1.82 “Transitional Services Agreement” is that agreement attached as Schedule 9 to this Agreement.

 

1.83 1.83 “VAT” means any value added tax or similar payment.

 

1.84 “Wholesaler” means any Third Party which purchases Product from Cardiome or any of its Affiliates and resells Product on its own account to Customers. For the avoidance of doubt, Wholesalers are not Third Party Distributors.

 

The definitions in this Article 1 shall apply equally to both the singular and plural forms of the terms defined. As used in this Agreement, (i) the words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation”; (ii) the words “hereof”, “herein”, “hereby” and derivatives or similar words refer to this entire Agreement; (iii) all references to Articles and Sections shall be deemed references to Articles and Sections of this Agreement and all references to Schedules shall be deemed references to Schedules to this Agreement, unless the context shall otherwise require; (iv) whenever this Agreement refers to a number of days, such number shall refer to calendar days unless otherwise specified; and (v) references to “Basilea” or to “Cardiome” shall be deemed to include each one’s Affiliates, unless expressly stated to the contrary.

 

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ARTICLE 2 APPOINTMENT AND PARTIES’ GENERAL CONDUCT

 

2.1 License Grant and Sublicenses .

 

(a) License Grant . With effect from the Effective Date, Basilea grants to Cardiome an exclusive, non-assignable license in the Territory in the Field under the Basilea IP to register and Commercialize the Product in the Territory and a co-exclusive (along with Basilea), non-assignable license under the Basilea IP to develop the Product in the Territory for Commercialization in the Territory. For the avoidance of doubt, the license does not include the right for Cardiome to manufacture the Product.

 

(b) Sublicenses .

 

(i) Cardiome has the right to grant a sublicense to the license granted under Section 2.1(a) to any of its Affiliates.

 

(ii) Cardiome shall notify Basilea in advance of the identity and planned role of any Third Party Licensees, Third Party Distributors and any other Third Party (with the exception of Wholesalers) which Cardiome or its Affiliates intend to use in Commercialization of the Product in order to enable Basilea adequate time to perform due diligence on such Third Parties. Cardiome will not grant a sublicense to any such Third Party without Basilea’s prior written consent (such consent not to be unreasonably withheld).

 

(iii) All permitted sublicenses under 2.1 (b) shall be consistent with the terms of this Agreement.

 

(iv) Notwithstanding any permitted sublicense, all obligations under this Agreement, including but not limited to reporting, planning, and financial obligations, remain with Cardiome.

 

2.2 Basilea Obligations . Basilea shall, in each case as Cardiome reasonably requires in the performance of its obligations under this Agreement:

 

(a) supply the Product to Cardiome;

 

(b) maintain the harmonized Dossier for the Product, submit any amendments to the Dossier, and manage the Mutual Recognition Process/Repeat-Use Procedures for the Product in the Territory;

 

(c) provide Cardiome on an ongoing basis with such Basilea Information (including but not limited to the Dossier) reasonably requested by Cardiome to fulfill its obligations under this Agreement;

 

(d) comply with and complete the requirements of the European Union PIP; and

 

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(e) at its sole cost and expense retain full and exclusive rights, title and interest to, and maintain the registrations (as applicable) for all Basilea IP that Basilea or its Affiliates own or Control during the Term.

 

2.3 Cardiome Obligations . Cardiome shall:

 

(a) register and Commercialize the Product in the Territory in line with the Commercial Launch Plan and thereafter in line with subsequent Commercialization Plans and actively promote the use and sale of the Product in order to maximize sales of the Product in the Territory;

 

(b) undertake all national regulatory activities in the Territory, maintain the National Marketing Authorisations in the Territory, and provide regulatory support to Basilea during any Mutual Recognition Process/Repeat-Use Procedures concerning countries in their Territory pursuant to Sections 4.1 and 4.2;

 

(c) purchase the Product exclusively from Basilea and for Commercialization in the Territory; and

 

(d) fulfill any and all of its obligations hereunder in accordance with all Applicable Law related to, including but not limited to, the registration, approval, marketing, promotion, distribution and sale of the Product, including GDP and all applicable local pharmaceutical industry codes and guidelines.

 

2.4 Restriction . Cardiome shall, and shall procure that its Affiliates and any Third Party Distributors and Third Party Licensees and Wholesalers shall, refrain from actively Commercializing the Product to Third Parties outside the Territory. Commercializing outside the Territory shall mean approaching or soliciting Third Parties outside the Territory, including, but not limited to, the following actions: (i) visits; (ii) sending unsolicited mail (including email); (iii) advertising in media, on the internet or other promotions, where such advertising or promotion is specifically targeted at Customers outside the Territory; (iv) online advertisements addressed to Customers outside the Territory and other efforts to be found specifically by users outside the Territory, including the use of territory based banners on Third Party websites and paying a search engine or online advertisement provider to have advertisements or higher search rankings displayed specifically to users outside the Territory; and (v) advertising or promotion in any form, or translation of Product-related website/s into a language other than an official language of the Territory, that would not reasonably have been carried out but for the likelihood that it will reach Customers outside the Territory.

 

2.5 Commercially Reasonable Endeavours . Both Parties shall use their Commercially Reasonable Endeavours in performance of their obligations under this Agreement.

 

2.6 Non-compete . To the extent permitted by Applicable Law, during the Term (on a country-by-country basis), Cardiome shall not, directly or indirectly market, sell or promote within the Territory any [...***...] In case of a breach by Cardiome of this Section 2.6, Basilea may terminate the Agreement in accordance with Section 14.4(b).

 

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2.7 No Material Adverse Impact . Cardiome shall not carry out any activity in the implementation of this Agreement in its Territory that has or is reasonably likely to have any material adverse impact on the Product outside the Territory, meaning a materially negative impact on the development, regulatory status, manufacturing or commercialization of the Product (a “Material Adverse Impact”), without Basilea’s prior consent (such consent not to be unreasonably withheld or delayed). The following shall not trigger this Section 2.7: (i) pricing reductions unilaterally imposed by a Regulatory Authority in the Territory; (ii) mandatory recalls required by a Regulatory Authority in the Territory; iii) actions imposed by Regulatory Authorities in the Territory for safety reasons such as: clinical trial suspension, change in labelling or market restrictions, or distribution of Dear Health Care Professional (DHCP) letters; and iv) any case where Cardiome as marketing authorization holder in the Territory or its responsible person for distribution; or the Qualified Person responsible for batch certification determines that Product that has been distributed in the Territory must be recalled.

 

2.8 Joint Steering Committee .

 

(a) The Parties will, upon execution of the Agreement, set up a joint committee (“Joint Steering Committee” or “JSC”) which shall consist of three (3) representatives from each Party (or such other number as may be agreed by the Parties). The JSC will facilitate communications between the Parties with respect to the obligations and responsibilities set out in this Agreement, including but not limited to reviewing, sharing and discussing the implementation of the Commercial Launch Plan, the Commercialization Plan, as well as commercialization strategies, such as brand strategies and Product positioning and life cycle management, and any other topics the Parties consider useful for the optimisation of this Agreement.

 

(b) General Committee Membership and Procedures.

 

(i) Membership : The Parties shall appoint representatives to the JSC who have appropriate expertise. The JSC shall have co-chairpersons; each Party may select from their representatives a co-chairperson for the JSC. Each Party may change its representatives or designated co-chairperson by written notice to the other Party. The co-chairpersons of the JSC shall be jointly responsible for calling meetings and preparing and circulating an agenda and any materials in advance of each meeting. The Party who hosted or requested the JSC meeting shall prepare the minutes of the meeting within thirty (30) days.

 

(ii) Meetings : Meetings of the JSC will be held at least every six (6) months, including by audio or video teleconference with the consent of each Party; provided that at least one (1) meeting per year of the JSC shall be held in person. The JSC shall meet alternately at each Party’s location. Each Party shall be responsible for all of its own expenses of participating in the JSC. Ad hoc meetings shall be held for urgent or important matters upon the request of a Party.

 

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(iii) Working Groups : The Parties may establish one or more working groups of the JSC from time to time as and when it deems appropriate to discuss specific aspects of the commercialization of the Product.

 

2.9 Operational Transfer of Activities and Transitional Services Agreement .

 

(a) Operational Transfer of Activities .

 

(i) Starting from the Effective Date, the Parties shall cooperate together through the JSC and through such other meetings and communication as needed, in order to plan and effectuate the transfer of operational activities from Basilea to Cardiome. The Parties shall cooperate to enable Basilea to transfer such information and activities and provide support, and Cardiome to undertake the activities and responsibilities, as specified in this Agreement including but not limited to the following sections: Section 3.6 (transfer of Basilea Core Materials), Article 4 (transfer of regulatory information and responsibility), Section 4.4 (negotiation of SDEA), Section 4.7 (transfer of market access information and responsibility), Section 5.6 (discussion of Artwork proposed by Cardiome), Section 6.1 (negotiation of Quality Agreements), and Section 6.7 (Basilea instructions regarding transport, storage and distribution of Product). Such activities shall be without charge on the part of either Party (unless such charge is specified in the relevant provision of the Agreement).

 

(ii) As part of Basilea’s obligation to provide Cardiome on an ongoing basis with such Basilea Information reasonably requested by Cardiome to fulfill its obligations under this Agreement pursuant to Section 2.2(c), Basilea shall provide to Cardiome the following:

 

(A) within thirty (30) days of Effective Date, a complete copy of the Dossier, a copy of all National Marketing Authorisations in the Territory, a copy of all related material Submissions to Regulatory Authorities and material responses from Regulatory Authorities, and an overview of any regulatory obligations or commitments for each country;

 

(B) within ten (10) days of the Effective Date, the Basilea Core Materials;

 

(C) within ten (10) days of the Effective Date, a list of all contracted or already discussed Investigator Initiated Trials (IITs);

 

(D) within twenty (20) days of the Effective Date, an overview of Basilea’s market access and pricing and reimbursement activities in the Territory, a copy of all material communications with all market access and pricing and reimbursement authorities, and, promptly after Cardiome’s request, a copy of the data cited by Basilea in such communications; and

 

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(E) at a date to be agreed by the Parties within thirty (30) days of the Effective Date, Basilea shall provide one day of in-person tender management and product training to Cardiome at Cardiome’s Geneva office.

 

(b) Transitional Services Agreement .

 

(i) Initial Transition Period . With effect from the Effective Date and until completion of the Initial Transition Period, all commercial sales of the Product shall be for Cardiome’s benefit, at Cardiome’s cost and risk, subject to the terms of this Agreement and the Transitional Services Agreement (TSA), which is attached as Schedule 9. During the Initial Transition Period (as defined in the TSA), Basilea shall, as particularly set forth in the TSA, continue to operate the business in normal course and Cardiome shall receive the benefit of the sales of the Product from which shall be deducted Basilea’s costs of operating the business.

 

(ii) Other Transitional Services . Further, under the Transitional Services Agreement, Cardiome can request and Basilea may provide certain additional transitional services deemed an Other Transitional Services during the Term of the Transitional Services Agreement.

 

2.10 Inventory . Attached to this Agreement as Schedule 8 is an estimate of Basilea’s inventory of Finished Product on a country-by-country basis for the Territory as of the Effective Date (the “Inventory”) with associated expiry dates. Basilea shall, ten (10) days prior to the end of the Initial Transition Period (on a country-by-country basis, if the Initial Transition Period ends on different dates in different countries), confirm the expected remaining amount of the Inventory at that time. Cardiome shall purchase the actual Inventory as of the end of the Initial Transition Period at the Assumed Transfer Price (with a later true-up based upon Net Sales reports pursuant to the mechanism provided in Section 7.2, on invoice from Basilea) if said Inventory has at least […***…] of shelf-life remaining on the Finished Product. Cardiome shall have a right of return for any Inventory that it is unable to sell due to either (i) too short shelf life (despite Cardiome having used its Commercially Reasonable Endeavours to sell such Inventory) or (ii) requirement of Regulatory Authority for repackaging or overstickering which one or both Parties are unable to fulfill using its (or their) Commercially Reasonable Endeavours. Basilea shall Deliver the Inventory to Cardiome EXW (Facility) and under the Delivery terms provided in Section 5.2 and 5.3; for the avoidance of doubt, Sections 5.5 and 5.6 shall not apply to Cardiome’s purchase of the Inventory. Cardiome shall pay such invoice by wire transfer, within sixty (60) days of receipt thereof, into an account designated by Basilea.

 

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ARTICLE 3 COMMERCIALIZATION

 

3.1 Commercialization, Commercialization Plans and Sales Forecast . Cardiome shall Commercialize the Product in the Territory. Cardiome will provide Basilea with the country-specific Commercialization Plans for the Product to Basilea for its review and comment within one (1) month of the Effective Date, including the information listed in Schedule 1 and shall provide the Commercial Launch Plan in the format provided in the template set forth in Schedule 4. Updated plans will be provided as such updates are generated by Cardiome, and no less often than on an annual basis, to Basilea for its review and comment by September 30 of each calendar year.

 

3.2 Promotion . Cardiome shall actively Commercialize the Product in the Territory and provide information and support related to the Product to physicians and other persons with a professional interest in the study and prescription of the Product. The promotion of the Product shall include, but is not limited to: (i) direct selling and including regular Details by Cardiome’s marketing/sales staff to provide Product information; and (ii) other lawful steps taken to draw the interest of physicians and other prescribers such as organizing conferences, seminars, physician training sessions, lectures, mailings with announcements and product brochures, publications in professional magazines, and participation in trade exhibitions or symposia.

 

3.3 Authorised Indications Only . Cardiome shall not promote the Product for uses or indications other than those specifically defined in the Product’s Marketing Authorisations for the Territory.

 

3.4 Sales Force . Cardiome shall maintain a well-trained, effective sales force to ensure the proper fulfilment of all of its Commercialization obligations in the Territory, including training and maintaining a sales force in the Territory at least in such number and/or compilation to effectively implement the Commercialization Plan. For the first two years of commercialization of the Product, Basilea shall provide to Cardiome a total of up to three (3) days per year with Product training in English at a location of Basilea’s choosing .

 

3.5 Compliance with Law . Cardiome shall instruct its sales force and other representatives to comply with any Applicable Law (including relevant industry codes) related to Cardiome’s Commercialization and medical affairs activities.

 

3.6 Marketing Materials .

 

(a) Basilea shall provide Cardiome with copies, whether electronic or otherwise, of representative samples in English of core promotional literature and advertisements for the Product used by Basilea in the markets where Basilea commercializes the Product prior to the Effective Date (‘‘Basilea Core Materials”). Basilea shall subsequently provide to Cardiome any substantial or material updates to the messages or information included in the Basilea Core Materials within ten (10) days of any such Basilea Core Materials updates.

 

(b) Cardiome shall use the Basilea Core Materials to create similar promotional literature and advertisements for the Product to Commercialize the Product in the Territory (“Cardiome Core Materials”). Cardiome shall customize the Cardiome Core Materials as appropriate for each country where it Commercializes the Product, including by obtaining professional translations of the Cardiome Core Materials into the official language(s) of the Territory.

 

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(c) To the extent that Cardiome wishes to vary materially from the Basilea Core Materials in the messages or information included in its Cardiome Core Materials, Cardiome shall provide to Basilea copies of such changes (in English) together with an explanation (in English) of the necessity for such changes for Basilea’s review and approval. Basilea will conduct a timely review (maximum twenty (20) business days) of such Cardiome Core Materials and will either confirm that Cardiome may use such Cardiome Core Materials, or request that reasonable changes are made.

 

(d) Cardiome shall provide Basilea with a copy of all Cardiome Core Materials (in English) and of all country marketing materials based thereon (in original language) and shall permit Basilea to share the Cardiome Core Materials on a confidential basis with any Basilea Affiliate or license partner in order to allow Basilea to coordinate its global sales and promotion of the Product.

 

(e) Cardiome shall ensure that the Cardiome Core Materials, training materials, and any representations made in relation to the Product comply with all Applicable Law and accurately represent Basilea’s current view of or approach in relation to the Product, including scientific content, communication and global marketing strategy as that view or approach has been communicated to Cardiome by Basilea, for example in the JSC.

 

3.7 Exclusive License Notification . To the extent permitted by Applicable Law, Cardiome shall indicate on the Cardiome Core Materials (including any internet site) and on the packaging of the Product, that the Product is exclusively licensed by Basilea to Cardiome in the Territory.

 

ARTICLE 4 REGULATORY MATTERS AND PHARMACOVIGILANCE

 

4.1 Regulatory Responsibility in Core European Territory .

 

(a) Cardiome’s Responsibilities .

 

(i) The Product is approved in certain EU countries under a decentralized procedure and Basilea holds National Marketing Authorisations in the Territory in Austria, Belgium, France, Germany, Italy, Luxembourg, Spain, and the UK as of the Effective Date. Promptly after the Effective Date, Basilea shall transfer all National Marketing Authorisations in these countries to Cardiome.

 

(ii) Basilea has completed the Repeat-Use Procedure for Ireland, Poland, and Portugal but has not yet received National Marketing Authorisations in these countries. Once Basilea receives the National Marketing Authorisations in these countries, Basilea shall transfer them to Cardiome

 

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(iii) Basilea holds a Marketing Authorization in Switzerland. Promptly after the Effective Date, Basilea shall transfer the Marketing Authorisation for Switzerland to Cardiome.

 

(iv) For any countries in the Core European Territory in which the Product is not yet registered, Cardiome shall notify Basilea of its intent to register the Product in such countries in line with the Commercial Launch Plan. Basilea shall thereafter initiate a Repeat-Use Procedure in such country within six (6) months of receipt of Cardiome’s notice of its intent to register in such country (such six (6) month period being elongated if there is an ongoing or urgent planned regulatory process not allowing the filing of the Repeat-Use Procedure within such timeframe). Once Basilea receives the National Marketing Authorisations in such countries, Basilea shall transfer them to Cardiome or, upon Cardiome’s request, to Cardiome’s approved Third Party Sublicensees (pursuant to Section 2.1).

 

(v) After transfer of the National Marketing Authorisations from Basilea pursuant to Sections 4.1(a)(i), (ii) or (iv), or transfer of the Marketing Authorisation for Switzerland pursuant to Section 4.1(a)(iii), Cardiome shall be the National Marketing Authorisation holder of all National Marketing Authorisations in the Core European Territory. Cardiome shall undertake all national regulatory activities and procedures including preparing and filing Submission of national variations and Submission of the national phase after the end of any harmonized EU procedure in the required format, e.g. eCTD, NeeS, etc.

 

(vi) For the avoidance of doubt, Cardiome shall conduct all regulatory activities under its responsibility as specified in Sections 4.1(a)(i)-(v) at its own cost, including but not limited to any costs Cardiome incurs in maintaining the National Marketing Authorisations and any Third Party costs incurred by Basilea related to these activities including the costs for filing for Marketing Authorisation Applications in countries where the Product is not yet registered.

 

(b) Basilea’s Responsibilities. Basilea will be responsible to oversee and maintain the harmonized Dossier and submit changes to the harmonized Dossier as needed, for instance related to variations and Repeat-Use Procedures pursuant to Section 4.1(a)(iv). Cardiome shall bear the submission costs and any Third Party costs incurred by Basilea (but not Basilea’s internal costs) for any such changes to the harmonized Dossier. For the avoidance of doubt, Basilea shall bear any submission costs for changes to the harmonized Dossier which are related solely to countries outside the Territory, or which are related to Basilea’s own decisions to change manufacturing processes or the locations or identities of manufacturing parties.

 

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4.2 Regulatory Responsibility in Non-EU Eastern European Territory . Cardiome will be responsible for and bear the cost of all regulatory activities in the Non-EU Territory and will be the Marketing Authorization Holder of all Authorisations gained in the countries of such territory. Cardiome shall prepare and file all Submissions in the Non-EU Eastern European Territory. Cardiome shall undertake such activities pursuant to the regulatory timelines and plans included in the Commercial Launch Plan and in the Commercialization Plans.

 

4.3 Transfer of Regulatory Information and Cooperation.

 

(a) Within thirty (30) days of the Effective Date, Basilea will provide to Cardiome the regulatory information specified in Section 2.9(a)(i)(A).

 

(b) The Parties will cooperate as necessary to effectuate the transfer of responsibilities from Basilea to Cardiome and in particular the transfer of any Authorisations promptly after the Effective Date (in the case of Authorisations existing as of the Effective Date) and promptly after grant of the Authorisation (in the case of Authorisations not yet granted as of the Effective Date). Cardiome shall prepare any necessary documentation of transfer for Basilea’s review and signature and Basilea shall review and sign (including with any legally required notarization or other formal requirements). Each Party shall bear its own cost for such activities.

 

(c) Upon reasonable request of either Party, the other Party will provide support in responding to questions from Regulatory Authorities related to the Product.

 

(d) Cardiome shall obtain and maintain all licenses and permits required for it to Commercialize the Product in the Territory, including but not limited to a Wholesaler Dealer License which Cardiome shall hold through an Affiliate located in the EU.

 

4.4 Regulatory Submission Responsibilities .

 

(a) Both Parties shall keep each other duly informed of any contacts, communications, correspondence and meetings with Governmental and Regulatory Authorities concerning the Marketing Authorizations and/or the Product and which might affect the Parties’ collaboration under this Agreement.

 

(b) For all material Submissions which Cardiome plans to make to Regulatory Authorities for the Product in the Territory, Cardiome shall, at least twenty (20) Business Days prior to the intended date of Submission, provide a copy of such Submission, including any Type II variations or renewals (in English) to Basilea for Basilea’s review and reasonable comments which shall be incorporated.

 

(c) For all Submissions which Basilea plans to make to Regulatory Authorities for the Product in the Territory, Basilea shall, at least twenty (20) Business Days prior to the intended date of Submission, provide a copy of such Submission (in English) to Cardiome for its review and comment, with reasonable comments to be incorporated.

  

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(d) Cardiome shall also (i) promptly inform Basilea of (A) the acceptance by any Regulatory Authority in the Territory of any Submission by Cardiome (or by any Affiliate or Third Party on its behalf), (B) the approval by any Regulatory Authority in the Territory of any Submission by Cardiome (or on its behalf) (including the grant of an Authorisation) or (C) any other change in the regulatory status of any Authorisation, in no event later than ten (10) Business Days after receipt by Cardiome of notice of the applicable event described in the foregoing (A), (B) and (C), and (ii) provide Basilea with a copy of all (A) Submissions by Cardiome (or on its behalf) to a Regulatory Authority in the Territory, in English and in editable electronic CTD format, or another editable format, where CTD format is unavailable and (B) any approvals by any Regulatory Authority in the Territory of any Submission by Cardiome (or on its behalf) (including the grant of an Authorisation), within ten (10) Business Days after making such Submission or receiving such approval.

 

(e) Basilea shall use Commercially Reasonable Endeavours to inform Cardiome about material changes to the Dossier (such as a change in manufacturer) which will require Submissions to Regulatory Authorities pursuant to Section 4.1(b), and Cardiome shall have the obligation to make corresponding Submissions in Non-EU Eastern European Territory and Switzerland.

 

4.5 Safety Data Exchange Agreement and Master Global Safety Database .

 

(a) Within twenty (20) days of the Effective Date, the Parties shall enter into a safety data exchange agreement (“Safety Data Exchange Agreement”) describing the procedures which Basilea and Cardiome shall implement and the responsibilities that both Parties will assume in order to ensure that: (i) the relevant safety information relating to the Product is exchanged in a timely manner; and (ii) that both Parties can fulfil their respective pharmacovigilance obligations under Applicable Law.

 

(b) Basilea shall have the responsibility of creating and maintaining the master global safety database for the Product.

 

(c) Prior to execution of the Safety Data Exchange Agreement and during the Initial Transition Period, Pharmacovigilance in the Territory shall be the responsibility of Basilea.

 

(d) After execution of the Safety Data Exchange Agreement and after completion of the Initial Transition Period, Pharmacovigilance in the Territory shall be the responsibility of Cardiome.

 

4.6 Cardiome’s Obligations Related to Studies and Tests . Subject to Section 4.7, Cardiome shall have the obligation to conduct all development activities for the Territory, as follows:

 

(a) Cardiome shall perform any activities required to fulfill post-approval commitments in the Territory and shall implement the risk management plan by performing the surveillance studies described therein. As of the Effective Date, three surveillance studies have been contracted and are a part of the risk management plan which has been approved by the Regulatory Authority. Cardiome shall not require Basilea’s prior approval to conduct such activities, but shall keep Basilea informed of its performance of such activities through regular reports, such as in the JSC.

 

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(b) In its discretion, Cardiome may support investigator initiated trials (“IITs”) related to the Product. Prior to providing such support, Cardiome shall inform Basilea of the planned IIT protocol and shall allow Basilea an opportunity to comment thereon.

 

(c) With the prior written approval of Basilea (in its sole discretion, not to be unreasonably withheld), Cardiome may (i) conduct any non-clinical or clinical study involving the Product and/or (ii) perform any Tests related to the Product.

 

(d) Cardiome shall be responsible for conducting all activities specified in Sections 4.6(a)-(c) and shall bear all related costs. Pharmacovigilance requirements related to such activities shall be described in the Safety Data Exchange Agreement. Cardiome shall conduct all clinical studies in compliance with the current Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, as well as according to ICH guideline (E6) for good clinical practice (cGCP). All data and reports from such activities conducted by Cardiome shall be maintained in compliance with Applicable Law and cGCP by Cardiome and shall be made available in timely fashion to Basilea in a standard industry format and media allowing reproducibility and independent analysis. Cardiome shall own all such data and reports and hereby grants to Basilea full use free of charge of all such data and reports in perpetuity, for any purpose related to the development, manufacturing, Regulatory Approval and commercialization of the Product, including the right to provide such data and reports to Basilea’s Affiliates and license partners.

 

4.7 Basilea’s Obligations Related to Studies and Tests . Subject to Section 4.6, Basilea will be responsible for, and bear the cost of conducting and supporting the European Union PIP and any Investigator Initiated Trial (IIT) and/or any other non-clinical or clinical study that was contracted prior to the Effective Date. Basilea will conduct the European Union PIP in compliance with Applicable Law.

 

4.8 Basilea’s Ongoing Phase 3 Program . As of the Effective Date, Basilea is planning a Phase 3 clinical program in SAB and ABSSSI, and potentially at a later date in CAP with the goal of a registration in the United States. Such studies could, if successful, enable an application for a label extension in the Territory for SAB and/or ABSSSI. The following shall apply with respect to this Phase 3 clinical program:

 

(a) Basilea shall be solely responsible to conduct and bear the costs for this phase 3 clinical program, and shall conduct such program in its sole discretion, including making any decision to cease conducting such program;

 

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(b) All data and knowledge produced from the Phase 3 clinical program shall be considered Know-How under this Distribution Agreement and therefore is licensed to Cardiome with no further compensation other than as specified in this Distribution Agreement. For the avoidance of doubt, the milestone in Section 8.2(b) shall be due in the event that the Product is approved with an indication for SAB in the countries specified in such Section;

 

(c) Basilea will inform Cardiome of the identity of the hospitals and investigators in the Territory with whom it plans to conduct any such clinical studies;

 

(d) Basilea will discuss with Cardiome through the JSC the outcome of the Phase 3 program and its plan to update the core harmonized Dossier for the Product as soon as reasonably possible upon completion of the studies, and Cardiome shall thereafter update the Commercial Launch Plan and/or the Commercialization Plan. The Parties shall thereafter cooperate to make such Submissions (pursuant to Section 4.4) as necessary to update the Dossier, in accordance with Article 4.1(b) and 4.2.

 

4.9 Market Access .

 

(a) Basilea will, to the extent allowed by Applicable Law, transfer all market access and pricing and reimbursement activities for the Product in the Territory to Cardiome promptly after the Effective Date. Thereafter, Cardiome will be responsible for gaining and maintaining national market access (including pricing, reimbursement and health technology assessments) and for market access on a regional, local and hospital level in the Territory. Upon Cardiome’s reasonable request, Basilea will at its own cost provide support and consultation in regard to compilation and negotiation of health technology assessments dossiers and other related documents relevant for the respective Regulatory Authorities. Cardiome shall keep Basilea informed and share with Basilea documents related to Cardiome’s market access and pricing and reimbursement activities with the Regulatory Authorities.

 

(b) If a Governmental or Regulatory Authority in the Territory provides significant incentives relating to the Commercialization in order to secure access to new anti-infective medicines, the Parties shall discuss in good faith the appropriate distribution between the Parties of such incentives.

 

4.10 Cessation of Regulatory or Commercialization Activities. If Cardiome plans to cease regulatory or Commercialization activities in a country or countries in the Territory, Cardiome shall inform Basilea through the JSC and there shall be a JSC discussion of such plan to ensure compliance with law and all regulatory requirements in such country or countries. For the avoidance of doubt, Cardiome’s obligation with respect to regulatory and Commercial activities in the Territory is to use its Commercially Reasonable Endeavours.

 

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ARTICLE 5 SUPPLY OF PRODUCT

 

5.1 Exclusive Supply. Cardiome shall purchase all of its requirements of the Product exclusively from Basilea.

 

5.2 Delivery. “Deliver,” “Delivered” and/or “Delivery” shall mean the delivery of Product by Basilea to Cardiome in the form of Finished Product (vials) EX-WORKS manufacturer (Incoterms 2010), which means Basilea delivers the Product when it places the Product at the disposal of Cardiome at a Facility chosen by Basilea, not loaded on any collecting vehicles and not cleared for export. Delivery location as of the Effective Date is at the premises [...***...] Basilea shall provide Qualified Person Release (meaning the certification by a Qualified Person that Product is manufactured in accordance with the requirements of the relevant authorizations pursuant to Annex 16 to the EU Guide to Good Manufacturing Practice) and certificates of compliance and certificates of analysis with each batch of Product at Delivery.

 

5.3 Stock. Cardiome shall maintain an appropriate stock of the Product for the Territory to ensure timely delivery to Wholesalers, Third Party Distributors, Third Party Licensees or Customers.

 

5.4 Minimum Purchase Quantities.

 

(a) A five-year plan (starting with the first full calendar year after the Effective Date) for the annual minimum quantities of Product to be purchased by Cardiome in Germany, France, UK, and Italy is attached as Schedule 5 and a five-year plan for the annual minimum quantities of Product to be purchased by Cardiome in other countries in the Territory shall be agreed by the Parties within three (3) months of the Effective Date (the quantities included in such attached plan and the quantities in the plan that will be agreed are “Minimum Purchase Quantities”). By the end of the fourth calendar year included in this five-year plan Cardiome shall propose Basilea the Minimum Purchase Quantities for the following five calendar years, which shall then be mutually agreed. Subsequent five year periods shall be planned in the same manner.

 

(b) Cardiome shall purchase not less than the Minimum Purchase Quantities listed in the five-year plans.

 

(c) As the Minimum Order Quantity may be in excess of the Minimum Purchase Quantity for a certain country in a certain year, if Cardiome in fact orders an amount of Product which is equivalent to or greater than the Minimum Order Quantity and is in excess of the Minimum Purchase Quantity for that country for the relevant year, then such excess amount (calculated as the difference between the amount ordered and the Minimum Purchase Quantity in a country) shall be credited against the next year’s Minimum Purchase Quantity for such country. Such credit shall carry forward only one year and shall not be applied to any subsequent years.

 

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(d) If Cardiome fails to purchase the Minimum Purchase Quantities (on a country-by-country basis) in any calendar year, the Parties shall discuss in good faith the reasons underlying Cardiome’s failure to meet such requirement, any corrective measures that Cardiome could take to potentially meet such requirement in future years, and whether the Minimum Purchase Quantities should be adjusted for a certain country or countries or for a certain time period. If Cardiome fails to purchase the Minimum Purchase Quantities for two consecutive calendar years in a certain country, Basilea may terminate the Distribution Agreement for that country in accordance with Section 14.4(f).

 

(e) If upon launch of a generic version of the Product or upon any other significant market change within the Territory, Cardiome reasonably determines that such generic competition or significant market change requires an adjustment of the Minimum Purchase Quantities or Minimum Transfer Price, the Parties shall discuss in good faith an adjustment of the respective Minimum Purchase Quantities and/or Minimum Transfer Price for the relevant country.

 

5.5 Order Forecasts, Purchase Orders and Shelf Life .

 

(a) Cardiome shall provide Basilea with the following order forecasts:

 

(i) within forty-five (45) days of the Effective Date a non-binding eighteen (18) month forecast of Cardiome’s estimated orders including the Delivery dates of such orders (number of packs of Finished Product per stock keeping unit) of the Product for each country in the Territory (“Initial Order Forecast”);

 

(ii) no later than six (6) months prior to the First Commercial Supply Date, and in each calendar month thereafter, a rolling forecast of Cardiome’s estimated orders including the Delivery dates of such orders (number of packs of Finished Product per stock keeping unit) of the Product for each country in the Territory for the eighteen (18) month period commencing with the month in which such forecast is provided (“Rolling Order Forecast”).

 

(b) The quantities of Product included in the first six (6) months of each Rolling Order Forecast shall be binding (“Binding Quantities”). For the avoidance of doubt, in each monthly update of the Rolling Forecast, the remaining five (5) months of the preceding Binding Quantities remain binding in each Rolling Order Forecast.

 

(c) Cardiome shall issue written Purchase Orders no later than six (6) months prior to the proposed Delivery date for Product and for amounts no less than provided in the Minimum Order Quantities.

 

(d) The Purchase Orders shall include quantities of Product within a range of ninety percent (90%) to one hundred and ten percent (110%) of the Binding Quantities. If Cardiome wishes to issue a Purchase Order in excess of such limits, Cardiome shall inform Basilea in due advance and Basilea shall have the right to respond to such request in its sole discretion. For the avoidance of doubt, the total quantities of Product purchased in any calendar year shall not fall short of the Minimum Purchase Quantities.

 

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(e) Upon receipt of a Purchase Order, Basilea shall confirm receipt and issue an acceptance form, confirming quantities and the target Delivery date, which shall be within forty-five (45) days of the proposed Delivery date indicated on the Purchase Order.

 

(f) In the event that Basilea anticipates any delay in Delivery of Product, Basilea shall inform Cardiome in writing of such delay and provide Cardiome with the updated Delivery date as soon as practicable.

 

(g) In the event of any conflict between the provisions of this Agreement, any Purchase Order, Basilea’s acceptance form or related invoice form, the provisions of this Agreement shall govern and control.

 

(h) […***…]

 

5.6 Artwork .

 

(a) No later than at the time of issuing the first Purchase Order for each country, Cardiome shall provide Basilea with all relevant information to perform secondary packaging for such country, including but not limited to art work, blister imprints, label, patient information leaflet and folding box or carton (together “Artwork”). Cardiome shall be responsible for confirming that Artwork complies with Applicable Law. Notwithstanding the above, for as long as it is permitted by the applicable Regulatory Authorities for Cardiome to sell Product using the currently approved Basilea Artwork, Cardiome may issue Purchase Orders for Product which bears the currently approved Basilea Artwork.

 

(b) Basilea shall within thirty (30) days of receipt of the Artwork from Cardiome send to Cardiome a proof-for-print Artwork for Cardiome’s final approval which Cardiome shall provide within ten (10) days of receipt of the proof-for-print. Basilea shall thereafter procure that Finished Product for the relevant country is produced using the Cardiome-approved Artwork.

 

(c) For all Purchase Orders following the first order of Product for each country, Cardiome shall inform Basilea if there shall be any change to the Cardiome-approved Artwork. Cardiome shall notify Basilea of any changes to the Artwork in line with the timelines set out in Sections 5.6(a) and (b).

 

(d) To the extent that any errors in Artwork in the Finished Product were present in the proof-of-print Artwork approved by Cardiome, Cardiome shall bear all costs of replacement or correction. In case errors occur which were not present in the proof-of-print Artwork approved by Cardiome, Basilea shall bear all costs of replacement or correction.

 

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(e) Basilea shall provide Cardiome with the estimated Third Party costs for the secondary packaging and related required quality activities no later than one hundred (100) days prior to the Delivery date. Cardiome shall confirm acceptance of the estimated secondary packaging costs. If no confirmation is provided by Cardiome within five (5) days, the secondary packaging costs are considered to be approved. Basilea shall charge Cardiome on a pass-through basis for the costs of preparation of Finished Product. If in any calendar year the pass through cost of secondary packaging, including labelling, for all of the countries combined, exceeds [...***...] of net sales for the relevant period, then the Parties shall discuss in good faith if any adjustment can be made to production planning or otherwise to reduce costs.

 

ARTICLE 6 MANUFACTURING STANDARDS AND QUALITY ASSURANCE

 

6.1 Quality Agreements. The Parties shall discuss in good faith and agree a Quality Agreement within thirty (30) days of the Effective Date or prior to the first Purchase Order, whichever occurs first, such Quality Agreement to cover the period of time during which Basilea supplies Cardiome and Basilea continues to hold the Marketing Authorisation in any country or countries in the Territory (the “First Quality Agreement”). The Parties shall subsequently discuss in good faith and agree a second Quality Agreement no later than the transfer date of the first Marketing Authorization to cover the period of time during which Basilea supplies Cardiome and Cardiome holds the Marketing Authorisation in any country or countries in the Territory (the “Second Quality Agreement”). Together the First Quality Agreement and the Second Quality Agreement shall be deemed the “Quality Agreements.” In the event of a conflict between the terms of the Quality Agreements and the terms of this Agreement with respect to quality issues, the terms of the Quality Agreements shall prevail. In the event of a conflict between the terms of the Quality Agreements and the terms of this Agreement with respect to non-quality issues, the terms of the Agreement shall prevail.

 

6.2 Manufacturing Standards. Basilea shall have manufactured and supply the Product strictly in accordance with the Specifications, Applicable Law, the requirements of the Dossier, and the Quality Agreement.

 

6.3 Maintenance and Retention of Records. Both Parties shall maintain detailed Records with respect to the Product in accordance with the Quality Agreement and Applicable Law.

 

6.4 Audits. Upon reasonable prior notice and the pre-agreement of the affected Facility, Cardiome may request that it or its approved Third Party Licensees be able to physically audit all Facilities (in which case Basilea may decide in its sole discretion to join such audit), or to join routine visits of Basilea to its Facilities. Cardiome shall bear all of its own and any Third Party costs of audits that it solely requests, and shall bear all of its own costs to join any routine visit of Basilea to a Facility. Conduct of periodic quality audits will be described in the Quality Agreement. In the event of Product Recall or an emergency, each Party shall provide necessary access as soon as practicably possible upon the other Party’s request.

 

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6.5 Inspections. If inspections are requested by a Regulatory Authority, each Party shall grant to the other Party reasonable access on reasonable prior notice during normal business hours to its sites or (as feasible) to the sites of its Third Party Licensees and Third Party Distributors to allow that Party to prepare for such Regulatory Authority inspection or to allow that representatives of any Regulatory Authority inspect and take copies of all material documentation as may be required by the Regulatory Authority. Cardiome shall bear all of its own and Third Party costs of pre-inspection visits that it requests.

 

6.6 Quality Tests and Checks. Basilea shall provide Product in accordance with the Specifications and shall conduct and document tests and test results (including but not limited to all bulk holding stability, manufacturing trials, validation (including, but not limited to, method, process and equipment cleaning validation), raw material, in-process, bulk finished product and stability (chemical and/or microbial) tests or checks required to assure the quality of the Product) in compliance with the Specifications, the approved Dossier, the Quality Agreement and Applicable Law.

 

6.7 Transportation, Storage and Distribution of Product. Cardiome shall transport, store and distribute the Product in accordance with: (i) applicable good distribution practice (GDP) principles and/or good manufacturing practice (GMP); (ii) associated guidelines; (iii) the approved Specifications in the Territory; and (iv) all Applicable Law.

 

6.8 Compliance with Basilea Instructions. Cardiome shall adhere to Basilea’s express instructions regarding storage and transport conditions for the Product (including but not limited to the temperature, humidity and safety data sheet) of which Basilea shall provide notice from time to time. If an excursion from the storage and transport conditions specified by Basilea occurs during Cardiome’s transport or storage of the Product, then Cardiome may request from Basilea, and Basilea shall provide, such data and information as is necessary for Cardiome to evaluate such excursion.

 

6.9 Inspection. Cardiome shall, within ten (10) business days following Delivery of Product, carry out an inspection and shall promptly notify Basilea in writing in sufficient detail of any visible nonconformity or nonconformity identified related to the certificate of conformance together with reasonable supporting documentation to evidence such nonconformity. If Cardiome does not notify Basilea in writing of rejection of such Delivery within such five (5) business days, the Delivery of Product shall be deemed to have been accepted by Cardiome.

 

6.10 Latent Defects. In case of an alleged Latent Defect found within the Product’s shelf life, Cardiome shall promptly upon discovery notify Basilea in writing in sufficient detail of the alleged Latent Defect together with reasonable supporting documentation to evidence such alleged Latent Defect.

 

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6.11 Return Authorisation .

 

(a) Within ten (10) days of receipt by Basilea of a notice of nonconformity from Cardiome in accordance with Section 6.9 or a notice of alleged Latent Defect in accordance with Section 6.10, Basilea shall indicate in writing to Cardiome whether Basilea will issue a return authorisation. In the event that Basilea issues a return authorisation, Cardiome shall return to Basilea the allegedly nonconforming or defective Product within ten (10) days of such notice at Basilea’s cost and Basilea shall free of charge replace such Product by conforming or non-defective Product as soon as reasonably practicable thereafter and shall bear the associated shipping costs.

 

(b) After receipt of a nonconformity notice from Cardiome pursuant to Section 6.9 or a notice of alleged Latent Defect in accordance with Section 6.10, if Basilea does not issue a return authorisation under Section 6.11(a), Basilea shall analyse any batch of Product rejected by Cardiome for alleged nonconformity or Latent Defect within sixty (60) days of receipt of such notice, and present its findings with respect to such Product to Cardiome.

 

(i) If such tests confirm nonconformity or a Latent Defect, Basilea shall supply to Cardiome conforming or non-defective Product in the same quantity as the rejected Product free of charge within a time: a) not exceeding ninety (90) days in the case of non-conforming Product; or b) in case of a Latent Defect, within a reasonable time for Basilea to address the Latent Defect and supply non-defective Product.

 

(ii) If such tests do not confirm nonconformity or a Latent Defect (meaning if Basilea’s tests confirm conformity and no Latent Defect), but if Cardiome does not accept Basilea’s findings and the Parties cannot agree on whether the Product in question is non-conforming or has a Latent Defect, an independent qualified laboratory shall analyse both Cardiome’s and Basilea’s samples of Product in question. The definitive results of such laboratory analysis shall be binding on the Parties as follows:

 

(A) the Party who is found to be responsible for nonconformity or Latent Defect by the laboratory shall bear the cost of the laboratory and the testing;

 

(B) if the Product in question is determined to be non-conforming or having a Latent Defect, it shall be held for Basilea’s disposition, or shall be returned to Basilea at Basilea’s cost and expense, as directed by Basilea and Basilea shall replace each non-conforming Product, or the portion of non-conforming Product, with conforming Product free of charge and bear the costs and expenses of shipment, as soon as reasonably practical after receipt of notice thereof; and

 

(C) if the Product in question is determined to be conforming or not having a Latent Defect, such Product shall remain with Cardiome or be returned to Cardiome at Cardiome’s cost and expense.

 

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6.12 Product Recall. The Parties shall comply with the Quality Agreement, particularly regarding Product Recalls, as amended from time to time. Cardiome shall prepare and implement standard operating procedures for the Recall of Product in the Territory that complies with the requirements of this Agreement and the Quality Agreement.

 

6.13 Decisions on Product Recall.

 

(a) Decisions to globally recall Product shall be made by Basilea at its discretion, to the extent permitted under Applicable Law.

 

(b) Decisions to recall Product in the Territory where Cardiome is marketing authorization holder shall be made by Cardiome at its discretion. To the extent permitted under Applicable Law; however, Cardiome shall provide Basilea with as much advance notice of such decisions as possible and shall discuss any planned or ongoing recall with Basilea and accept Basilea’s reasonable input regarding such recall.

 

(c) Both Parties shall cooperate with the other party with regard to any recall and shall comply with the procedures set forth in the Quality Agreement.

 

(d) Basilea shall reimburse Cardiome’s reasonable costs of complying with this Section 6.13 (including expenses related to communications and meetings with all required Regulatory Authorities, reimbursement of the Assumed Transfer Price or Actual Transfer Price actually paid by Cardiome to Basilea for any recalled Product, expenses relating to the replacement of the recalled Product, the cost of notifying Customers and shipping costs associated with the Recall), provided that the Recall was: (i) the result of a Recall outside the Territory or a global recall; or (ii) the result of out of Specification Product; or (iii) was not caused directly or indirectly as a result of the breach of this Agreement, the Safety Data Exchange Agreement or the Quality Agreement by, or any negligence or willful act or omission on the part of Cardiome, its Affiliates, Third Party Distributors, Third Party Licensees, Wholesalers or subcontractors. If the Recall occurs directly or indirectly as a result of the breach of this Agreement, the Safety Data Exchange Agreement or the Quality Agreement by, or any negligence or willful act or omission on the part of, Cardiome, its Affiliates, Third Party Distributors, Third Party Licensees, Wholesalers or subcontractors, then Cardiome shall bear its own costs of the Recall and a fair portion of Basilea’s costs associated with the Recall.

 

6.14 Customer Inquiries. Cardiome shall handle all Customer inquiries in the Territory relating to the Product. Each Party shall promptly report in writing to the other Party all suspected Product defects or other problems relating to the use of the Product in the Territory and the Parties shall keep each other reasonably informed of Customer complaints concerning such defects or problems as further defined in Quality Agreements. If Cardiome receives any request or inquiry related to sales of the Product outside of the Territory, Cardiome shall inform Basilea of such requests or inquiries within five (5) business days.

 

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ARTICLE 7 ASSUMED AND ACTUAL TRANSFER PRICE; PAYMENT TERMS

 

7.1 Cardiome shall pay the price for each Bulk Vial of Product purchased from Basilea in accordance with this Article 7.

 

7.2 The Assumed Transfer Price (in Swiss Francs) for Bulk Vials of the Product in each country of the Territory until the completion of the first four (4) calendar quarters following the Effective Date is provided in Schedule 8. The Assumed Transfer Price will be agreed upon between the Parties on an annual basis at least thirty (30) days prior to the beginning of each relevant period, provided that if the Parties are unable to agree, the Assumed Transfer Price for a subsequent period shall be equivalent to the Actual Transfer Price in the previous four calendar quarters.

 

7.3 Actual Transfer Price and Minimum Transfer Price

 

(a) The Actual Transfer Price for Bulk Vials of the Product in the Territory shall be calculated as follows:

 

(i) [...***...] of Net Sales until completion of the first four (4) full calendar years following the Effective Date;

 

(ii) [...***...] of Net Sales starting from the fifth (5th) calendar year until the end of the eighth (8th) year;

 

(iii) [...***...] of Net Sales starting from the ninth (9th) calendar year until the end of the Term.

 

(b) Notwithstanding the above, in no event shall the Actual Transfer Price paid by Cardiome to Basilea be less than the Minimum Transfer Price, however the following (i) and (ii) apply:

 

(i) [...***...]

 

(ii) [...***...]

 

(c) If the situation in (b)(ii)(a) has occurred in two sequential calendar quarters, then the Parties shall hold good faith discussions of the situation to try to find solutions.

 

7.4 Basilea shall invoice Cardiome for each Delivery of Product contained in such Delivery, based on the Assumed Transfer Price in Swiss Francs. Such invoice will include value added taxes, if applicable. Cardiome shall pay by bank transfer the relevant invoice within forty-five (45) days of receipt of such invoice. If Cardiome is overdue with any payment hereunder, then without prejudice to Basilea’s other rights or remedies, Cardiome shall be liable to pay interest on the overdue amount at the annual rate of three percent above the three (3) month London Interbank Rate, which interest shall accrue on a daily basis from the date payment becomes overdue until Basilea has received full payment of the overdue amount together with all interest that has accrued, and shall be payable within ten (10) calendar days of the date of Basilea’s invoice in respect of the same.

 

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7.5 Within fifteen (15) days following (i) the end of each calendar quarter and (ii) the expiration or earlier termination of this Agreement, Cardiome shall provide Basilea with a Net Sales report including detailed itemized (in accordance with Section 1.57) calculations of the Net Sales on a country-by-country level (in local currency and in Swiss Francs) and including the number of vials of Product sold in the Territory during such calendar quarter. All amounts which require conversion from local currencies into Swiss Francs shall be converted based on the quarterly average rates published on http://www.oanda.com/currency/average for the respective currency and for the respective calendar quarter. Cardiome shall include such currency rates used to convert local currencies to Swiss Francs in the Net Sales report.

 

7.6 Basilea shall promptly calculate the Actual Transfer Price per vial of Product on a country by country basis in Swiss Francs based on the reported Net Sales and compare the Assumed Transfer Price per vial invoiced to Cardiome during such calendar quarter against the Actual Transfer Price per vial calculated for that calendar quarter. If the result of such comparison is that the Actual Transfer Price per vial is greater than the Assumed Transfer Price per vial, Basilea shall invoice Cardiome for the difference (calculated by multiplying the difference between the Actual Transfer Price per vial and the Assumed Transfer Price per vial by the number of vials sold to Cardiome during such calendar quarter), such invoice being payable by Cardiome within thirty (30) days of its date. If the result of such comparison is that the Assumed Transfer Price is greater than the Actual Transfer Price, Basilea shall at Cardiome’s sole option either refund back to Cardiome the calculated amount within thirty (30) days or credit to Cardiome in subsequent invoices such calculated difference until all such credits are finally settled. In no circumstances shall the Actual Transfer Price be less than the respective Minimum Transfer Price, unless otherwise agreed by Basilea in writing.

 

7.7 Clawback/Payback/ Managed Entry Requirements Report .

 

(a) No later than thirty (30) days after the end of each calendar year on a country-by-country basis, Cardiome shall provide Basilea with a report (“Clawback/Payback/ Managed Entry Requirements Report”) showing a detailed calculation of any Paybacks, Clawbacks or Managed Entry Requirements imposed on Cardiome by a competent Regulatory Authority based on Applicable Law during the preceding calendar year.

 

(b) Based on each Clawback/Payback Managed Entry Requirements Report, Basilea shall promptly, and on a cumulative yearly basis of the preceding calendar year, calculate any changes to the Actual Transfer Price per vial of Product previously calculated by Basilea (the “Adjusted Actual Transfer Price”).

 

(c) If the calculation in (b) shows that the Actual Transfer Price for the total preceding calendar year is greater than the yearly cumulated total Adjusted Actual Transfer Price for the preceding calendar year, Basilea shall inform Cardiome of such, and thereafter, if the Adjusted Actual Transfer Price per vial is higher than the Minimum Purchase Price, shall refund to Cardiome the difference between the Adjusted Actual Transfer Price and the Actual Transfer Price, such refund to be paid by Basilea within thirty (30) days from Basilea’s receipt of Cardiome’s request for such refund.

 

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(d) If the calculation in (b) shows that the Adjusted Actual Transfer Price per vial is lower than the Minimum Transfer Price, the applicable Minimum Purchase Price for the relevant period and country will be reduced by [...***...] of the difference between the Actual Transfer Price and the Adjusted Actual Transfer Price (“Adjusted Minimum Transfer Price”), and Basilea shall refund to Cardiome the difference between the Adjusted Actual Transfer Price and the Actual Transfer Price, such refund to be paid by Basilea within thirty (30) days from Basilea’s receipt of Cardiome’s request for such refund. For the avoidance of doubt, in no event shall the payment made by Cardiome to Basilea be less than the Adjusted Minimum Purchase Price per Bulk Vial of Product for the relevant period and country.

 

(e) As an example, [...***...]

 

(f) The conversion of the difference between the Adjusted Actual Transfer Price and the Actual Transfer Price from local currency into Swiss Francs for each SKU will be done on a country-by-country basis using the average yearly rates published on http://www.oanda.com/currency/average for the respective currency.

 

(g) For the avoidance of doubt, Basilea will be responsible for any and all Clawback/Payback payments, (including payments due to AIFA) that have been incurred prior to the Effective Date. Any Clawback/Payback payments which relate to a time period before prior to and after the Effective Date shall be borne by each Party on a prorated basis and Cardiome will be responsible for any portion that is related to the time period starting on and continuing after the Effective Date.

 

7.8 Any and all expenses, costs and charges incurred by Cardiome in the performance of its obligations under this Agreement shall be paid by Cardiome, unless otherwise agreed in writing with Basilea.

 

7.9 Each Party shall pay all sums payable by it under this Agreement free and clear of all deductions or withholdings unless the Applicable Law require a deduction or withholding to be made.

 

7.10 Cardiome and Basilea will cooperate with respect to all documentation required by any tax authority, or reasonably requested by Cardiome or Basilea related to any payment or other obligations under this Agreement to ensure that Cardiome and Basilea can submit any tax filings in line with local regulations and requirements.

 

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ARTICLE 8 EXECUTION PAYMENT; REGULATORY PAYMENTS; MILESTONE PAYMENTS

 

8.1 Execution Payment. Upon execution of this Agreement, Cardiome will pay to Basilea an execution payment of CHF 5,000,000 (five million Swiss Francs) (“Execution Payment”).

 

8.2 Milestone Payments.

 

(a) Sales Milestone Payments . When aggregate annual Net Sales in the Territory in any calendar year reach the following thresholds for the first time, Cardiome will make the following one-time milestone payments to Basilea within thirty (30) days of the respective thresholds being reached:

 

Threshold in EUROs (aggregate annual
Net Sales in the Territory in any calendar
year)
  Milestone payments in EUROs
[...***...]   [...***...]
[...***...]   [...***...]
[...***...]   [...***...]
[...***...]   [...***...]
[...***...]   [...***...]
[...***...]   [...***...]
[...***...]   [...***...]
[...***...]   [...***...]
[...***...]   [...***...]
[...***...]   [...***...]

 

For the avoidance of doubt, in the event more than one threshold as listed above is reached in any calendar year for the first time, Cardiome shall make all one-time milestone payments achieved to Basilea (no matter whether more than one is achieved during a single calendar year).

 

(b) Regulatory Milestone Payment. When the Product is approved with an indication for bacteremia in all five (5) of the countries, Germany, France, Italy, Spain, and the UK, Cardiome will make a one-time milestone payment [...***...] to Basilea within thirty (30) days of the milestone being met.

 

ARTICLE 9 REPRESENTATIONS AND WARRANTIES

 

9.1 Mutual Warranties. Each Party represents, warrants and covenants to the other Party that:

 

(a) it has full corporate power and authority to enter into the Agreement and to carry out its obligations hereunder;

 

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(b) it is duly authorised to execute and deliver the Agreement and to perform its obligations under the Agreement. The person executing the Agreement on the Party’s behalf has been duly authorised to do so by the Party’s articles of association or requisite corporate action;

 

(c) this Agreement is legally binding and enforceable in accordance with its terms. The execution, delivery and performance of the Agreement by a Party will not be prevented or impaired by any agreement, instrument or understanding, oral or written, to which that Party is a Party or by which that Party may be bound, nor violate any Applicable Law; and

 

(d) it is aware of no action, legal proceedings or inquiry or investigation instituted by any governmental or regulatory agency or by any other person or company that might question or threaten the validity of the Agreement.

 

9.2 Warranties of Basilea. Basilea represents warrants and undertakes to Cardiome that:

 

(a) Basilea or one of its Affiliates Controls or is the legal and beneficial owner or applicant for registration of each of the Trade Marks, Domains and Patents;

 

(b) the details of the Trade Marks, Domains and Patents are correct in all material respects;

 

(c) with respect to its activities related to the Product in the Territory under this Agreement, it shall not, and shall procure that each of its employees, directors, officers, Affiliates, Third Party Distributors, Third Party Licensees, Wholesalers, subcontractors, agents, representatives and other involved Third Parties shall not (i) offer, promise or give an advantage to another person, or (ii) request, agree to receive or accept a financial or other advantage in violation of any anti-corruption laws, rules, regulations and decrees applicable to the respective Party (collectively, “Anti-Corruption Legislation”), including but not limited to the United States Foreign Corrupt Practices Act, as amended (the “FCPA”), the United Kingdom Bribery Act 2010 (the “Bribery Act”) and any implementing legislation under the OECD Convention Against the Bribery of Foreign Government Officials in International Business Transactions (“OECD Convention”). It is Basilea’s responsibility to be familiar with, and comply with, the provisions of the applicable Anti-Corruption Legislation;

 

(d) all actions required to be taken to prosecute and maintain the Trade Marks, Domains and Patents (including payment of all applicable annuities due and payable) have been and will be taken or paid during the Term;

 

(e) all documents provided in the dataroom for Cardiome’s review are owned or under the Control of Basilea and can be provided to Cardiome as needed for it to undertake its obligations under this Agreement, and Basilea and its Affiliates have not, to its best knowledge, withheld from Cardiome any material information in the possession of Basilea or its Affiliates related to the safety, toxicity, quality or efficacy of the Product that a biopharmaceutical company would reasonably consider to be material for a Regulatory Authority’s evaluation of the safety, toxicity, quality and/or efficacy of the Product;

 

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(f) Basilea has not received any material written communications alleging that the conduct of the Parties’ responsibilities as currently proposed under this Agreement would violate any of the intellectual property rights of a Third Party, and Basilea is not aware of any fact that is likely to give rise to such allegation from any Third Party;

 

(g) with respect to its activities related to the Product in the Territory under this Agreement, it shall ensure compliance with any applicable sanctions, prohibitions or restrictions under United Nations resolutions or the trade or economic sanctions, laws or regulations of the European Union, United Kingdom or United States of America;

 

(h) Basilea and its Affiliates have not, to its best knowledge, withheld from any Regulatory Authority any material information in the possession of Basilea or its Affiliates related to the safety, toxicity, quality or efficacy of the Product that a biopharmaceutical company would reasonably consider to be material for a Regulatory Authority’s evaluation of the safety, toxicity, quality and/or efficacy of the Product;

 

(i) none of Basilea or its Affiliates is engaged in any proceedings in any court, arbitration, administrative or other tribunal anywhere in the world which affects or relates to the Product (including but not limited to claims relating to product liability);

 

(j) Basilea is not aware of any Patents of any Third Party that covers the composition of matter of Drug Substance, or the use of Drug Substance or Product for the Subject Indication and that would be infringed by the manufacture, Development or Commercialization or the use of the Drug Substance or Product in the Territory;

 

(k) there are no pending proceedings in any court, arbitration, patent office, or administrative or other tribunal which are concerned with the ownership of any of the Basilea IP and to the best knowledge of Basilea and its Affiliates, as of the Effective Date, there are no pending proceedings in any court, arbitration, patent office, administrative or other tribunal which are concerned with the validity of any of the Basilea IP (other than any pending Trade Mark, Domain or the Patent applications or registration proceedings);

 

(l) Basilea will Deliver the Product to Cardiome which has been manufactured in compliance with the manufacturing standards in Section 6.2, and Basilea will comply with all Applicable Laws and good manufacturing practice (cGMP) and good distribution practice (GDP) relating to the manufacturing and supply of the Product under this Agreement; and

 

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(m) Basilea confirms that it is not aware of any Product recalls or Product defect notices that may impact patient safety, quality or efficacy of the Product, and that it is not aware of any Regulatory Authority inspection findings or proceedings that will impact Basilea’s ability to supply Product in accordance with this Agreement.

 

9.3 Warranties of Cardiome. Cardiome represents, warrants and undertakes to Basilea that:

 

(a) it shall, and shall procure that each of its employees, directors, officers, Affiliates, Third Party Distributors, Third Party Licensees, Wholesalers, subcontractors, agents and representatives shall fulfil any and all of its obligations hereunder in accordance with all Applicable Law related to, including but not limited to, the registration, approval, marketing, promotion, storage, distribution and sale of the Product, including good manufacturing practice (cGMP), good distribution practice (GDP) and all applicable local pharmaceutical industry marketing and promotion codes and guidelines;

 

(b) it shall not, and shall procure that each of its employees, directors, officers, Affiliates, Third Party Distributors, Third Party Licensees, Wholesalers, subcontractors, agents, representatives and other involved Third Parties shall not (i) offer, promise or give an advantage to another person, or (ii) request, agree to receive or accept a financial or other advantage in violation of any anti-corruption laws, rules, regulations and decrees applicable to the respective Party (collectively, “Anti-Corruption Legislation”), including but not limited to the United States Foreign Corrupt Practices Act, as amended (the “FCPA”), the United Kingdom Bribery Act 2010 (the “Bribery Act”) and any implementing legislation under the OECD Convention Against the Bribery of Foreign Government Officials in International Business Transactions (“OECD Convention”). It is Cardiome’s responsibility to be familiar with, and comply with, the provisions of the applicable Anti-Corruption Legislation;

 

(c) it shall ensure compliance with any applicable sanctions, prohibitions or restrictions under United Nations resolutions or the trade or economic sanctions, laws or regulations of the European Union, United Kingdom or United States of America. Basilea is exempt from fulfilling its obligations under this Agreement to the extent that the fulfilment of such obligation would expose Basilea to any damages or claims under United Nations resolutions or the trade or economic sanctions, laws or regulations of the European Union, United Kingdom or United States of America; and

 

(d) from time to time, at the reasonable request of Basilea, it shall confirm in writing that it has complied with its undertakings under this Section 9.3 and shall provide any information reasonably requested by Basilea to demonstrate such compliance.

 

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ARTICLE 10 INTELLECTUAL PROPERTY

 

10.1 Ownership and Maintenance. Basilea shall at its sole cost and expense retain full and exclusive rights, title and interest to, and maintain the registration (as applicable) for all Basilea IP licensed to Cardiome in the Territory that Basilea or its Affiliates own or Control during the Term.

 

10.2 Alternative Marks. If it is not permissible or advisable for regulatory, legal or other reasons in a country in the Territory to use the Trade Marks as the brand name of the Product, an alternative trademark that is available and that can be registered will be used as the brand name of the Product in the Territory. Such alternative trademarks will be determined by Cardiome after good-faith discussion with Basilea and Basilea shall own and maintain such trademark in the Territory. To the extent permitted under Applicable Law, Basilea’s name shall be included on packaging of Product.

 

10.3 Notification of Infringements.

 

(a) If Cardiome becomes aware of any actual, threatened or suspected infringement by a Third Party of any Patents, Know-how, Basilea Information or Trade Marks relating to the Product in the Territory, it shall promptly inform Basilea in writing and vice versa. Basilea shall have the first right, but not the obligation, to bring, defend, or maintain any suit or action or to control the conduct thereof against any actual, threatened or suspected infringement and Cardiome shall upon reasonable request from Basilea assist and cooperate with Basilea in any such enforcement or defence (with Basilea to reimburse Cardiome for all its reasonable out of pocket costs and expenses, if any, relating to such enforcement or defence). If Basilea requests Cardiome to join Basilea in such suit or action, Cardiome (including any Affiliate of Cardiome) shall execute all papers and perform such other acts as may be reasonably required, in which case Basilea shall reimburse Cardiome for all its reasonable out of pocket costs and expenses, if any. If Basilea (or its designated Basilea Affiliate) lack standing to bring any such action, then Basilea may ask Cardiome to do so, in which case Basilea shall reimburse Cardiome for its reasonable out of pocket costs and expenses in connection therewith, if any, and Cardiome shall conduct such action in accordance with Basilea’s instructions. Any recoveries obtained by Basilea as a result of any proceeding against a Third Party infringer shall be allocated as follows:

 

(i) Such recovery shall first be used to reimburse each Party for all reasonable litigation costs in connection with such litigation paid by that Party (other than those already reimbursed to Cardiome under Section 10.3(a));

 

(ii) such recovery shall then be used to compensate each Party for the respective damages suffered from the infringement of the respective Patents, Know-how, Basilea Information, Domains or Trade Marks relating to the Product in the Territory, provided that in the event the remaining portion of the recovery is not sufficient to compensate each Party’s damages, such compensation shall be paid on a pro-rata share based on the respective damages suffered, provided, however, if such respective damages suffered cannot be reasonably ascertained, the recovery shall be equally shared between the Parties; and

 

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(iii) the remaining portion of such recovery, if any, shall be shared between the Parties in accordance with their respective share of payments under (ii).

 

(b) If Basilea chooses not to take any action, after the expiration of a three (3) months period after notification by Cardiome of actual infringement, to obtain a discontinuance of infringement of the respective Patents, Know-how, Basilea Information or Trade Marks relating to the Product in the Territory, nor to file a suit against any such Third Party infringer, then Cardiome shall have the right, but not the obligation, to take action or bring suit against such Third Party infringer.

 

(c) The enforcing Party has the right at any time and at its sole discretion to enter into any settlement or compromise of any Claim or Proceeding in relation to the Product.

 

10.4 No Challenge. Cardiome shall not contest or challenge the validity or ownership of, or aid or assist others to contest or challenge the validity or ownership of, any Patents, Trade Marks, regulatory applications, Know-how, Domains or other Basilea Information in or relating to the Product. Basilea may terminate this Agreement in whole or in part in accordance with Section 14.4(f) should Cardiome breach this Section 10.4.

 

10.5 No Transfer of Goodwill. To the extent necessary to conduct Commercialization, Cardiome and its Affiliates shall have an exclusive non-assignable right and license to use the Trade Marks and Domains for Commercializing the Product in the Territory during the Term in accordance with this Agreement. The use by Cardiome and its Affiliates of the Trade Marks shall not constitute or imply any assignment or transfer of the Trade Marks or any goodwill associated with it. Whatever use Cardiome makes of the Trade Marks shall inure to the sole and exclusive benefit of the Product in accordance with this Agreement.

 

10.6 Use of Corporate Name. Neither Party shall use the other Party’s corporate name, or use any trade marks (other than the Trade Marks and Domains and only in accordance with the terms and conditions of this Agreement) in connection with any publication or promotion without the other Party’s prior written consent which shall not be unreasonably withheld. The above restriction will not apply to representations that Cardiome is the exclusive licensee and exclusive distributor of Basilea for the Product in the Territory.

 

10.7 No Survival. Upon the expiration or termination of this Agreement for any reason, except with respect to any remaining stock of the Product, Cardiome agrees to immediately discontinue all use of the Trade Marks and Domains and shall immediately discontinue any and all representations, direct or implied that it is a distributor or licensee of Basilea.

 

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ARTICLE 11 INDEMNIFICATION AND LIABILITY

 

11.1 Indemnification .

 

(a) Cardiome shall defend, indemnify and hold Basilea, its Affiliates and their directors, officers, employees and agents (collectively, “Basilea Indemnitees”), harmless from and against any Losses arising out of or in relation to Third Party claims, actions, suits or other proceedings, or demands (“Third Party Claims”) based on Cardiome’s and its Affiliates (i) breach of any of the provisions of this Agreement, the Quality Agreement or the Safety Data Exchange Agreement; (ii) breach of its warranties under this Agreement; (iii) violation of Applicable Law; or Third Party Claims relating to this Agreement caused by the intent (willful act) or negligence of Cardiome and its Affiliates.

 

(b) Basilea shall defend, indemnify and hold Cardiome, its Affiliates and their directors, officers, employees and agents (collectively, “Cardiome Indemnitees”) harmless from and against any Losses arising out of or in relation to Third Party claims, actions, suits or other proceedings, or demands (“Third Party Claims”) based on (a) Basilea’s and its Affiliates (i) breach of any of the provisions of this Agreement, the Quality Agreement or the Safety Data Exchange Agreement; (ii) breach of its warranties under this Agreement; (iii) violation of Applicable Law; or Third Party Claims relating to this Agreement caused by the intent (willful act) or negligence of Basilea and its Affiliates, (b) any assertion by a Third Party that its intellectual property rights are or will be infringed or misappropriated by Commercializing of Product, except to the extent that such alleged infringement or misappropriation is attributable to (i) the use of any information or materials other than those provided by Basilea to Cardiome or (ii) the use of such marks, logos or design, other than the Trade Marks, as determined by Cardiome in its sole judgement in Commercializing of Product, (c) for death, personal injury or property damage arising out of, or in connection with, any defective Product which was Delivered by Basilea to Cardiome, except to the extent that the defect is attributable to the acts or omissions of Cardiome Indemnitees.

 

(c) The indemnity obligations of each Party under this Article 11 shall be conditioned upon the following:

 

(i) the indemnified Party giving a prompt notice of a Third Party Claim no later than thirty (30) days of the indemnified Party’s receipt of such Third Party Claim;

 

(ii) the indemnified Party providing reasonable cooperation with the indemnifying Party in the defence of such Third Party Claim: and

 

(iii) the indemnified Party’s agreement not to settle such Third Party Claims without the indemnifying Party’s prior written consent, such consent not to be unreasonably withheld or delayed.

 

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(d) Nothing in this Agreement shall be deemed to exclude or limit the liability of either Party for any form of liability that may not be excluded or limited by Applicable Law.

 

11.2 Limit on Liability . Neither Party, its Affiliates or their respective officers, directors, employees, agents and representatives shall be liable to the other, its Affiliates or their respective officers, directors, employees, agents and representatives whether in contract, tort (including negligence) or for breach of statutory duty or misrepresentation, or otherwise, for any:

 

(i) loss of profits;

 

(ii) loss of contracts or opportunity; or

 

(iii) indirect, special, incidental or consequential damages suffered by any person under or in connection with this Agreement.

 

ARTICLE 12 INSURANCE

 

12.1 During the Term of this Agreement and for a period of three (3) years thereafter, Basilea, its Affiliates and subcontractors shall procure and maintain a minimum of general liability insurance (which shall include product liability) under ordinary terms and conditions standard in the pharmaceutical industry, with limits of not less than the equivalent of USD […***…] per occurrence and in aggregate with insurers who are reputable and financially sound.

 

12.2 During the Term of this Agreement and for a period of three (3) years thereafter, Cardiome, its Affiliates and subcontractors shall procure and maintain a minimum of general liability insurance for all countries in the Territory (which shall include product liability) under ordinary terms and conditions standard in the pharmaceutical industry, with limits of not less than the equivalent of USD […***…] per occurrence and in aggregate with insurers who are reputable and financially sound.

 

12.3 In addition, upon request, both Parties will provide the other with written evidence of such cover with insurers who are reputable and financially sound.

 

12.4 Each Party shall bear the costs for any deductibles/retentions for its insurance policy.

 

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ARTICLE 13 CONFIDENTIAL INFORMATION

 

13.1 For the purpose of this Article 13 only, any reference to a Party shall also be understood to include all of its Affiliates which either receive or provide Confidential Information. Each Party shall further procure that any Third Party to whom it provides Confidential Information (whether Third Party Distributors, Third Party Licensees, Wholesalers, or any other Third Party) is bound to protect such information under terms at least as onerous as those contained herein. A Party receiving Confidential Information from the other Party shall (i) maintain in confidence such Confidential Information to the same extent such Party maintains its own Confidential Information; (ii) not disclose such Confidential Information to any Third Party without prior written consent of the other Party; and (iii) not use such Confidential Information for any purpose except as permitted by this Agreement. “Confidential Information” shall mean (i) any and all information including any proprietary data, inventions, ideas, discoveries and materials (whether or not patentable or protectable as a trade secret) (whether or not it falls within the Basilea Information or Know-how) not generally known to the public regarding a Party’s technology, products, business or objectives, in each case, which are disclosed or made available by a Party (such Party being referred to as the “Disclosing Party”) to the other Party (such Party being referred to as the “Receiving Party”) in connection with this Agreement, (ii) all information developed during the course of performing the obligations set out in this Agreement, which shall be the Confidential Information of the relevant Party (if developed by that Party alone) or of the Parties jointly (if developed by the Parties jointly) and (iii) the fact that the Parties entered into this Agreement, the Quality Agreement and the Safety Data Exchange Agreement, and the content of this Agreement, the Quality Agreement and the Safety Data Exchange Agreement. The obligations under this Article 13 shall remain in force until the expiration of five (5) years after Cardiome stops Commercializing the Product in the Territory.

 

13.2 The obligations set forth in this Article 13 shall not apply with respect to any portion of such Confidential Information which:

 

(a) is publicly disclosed by the Disclosing Party, either before or after it becomes known to the Receiving Party; or

 

(b) was known to the Receiving Party, without obligation to keep it confidential, prior to when it was received from the Disclosing Party; or

 

(c) is subsequently disclosed to the Receiving Party by a Third Party lawfully in possession thereof without obligation to keep it confidential; or

 

(d) has been published by a Third Party or otherwise enters the public domain through no fault of the Receiving Party in breach of this Agreement; or

 

(e) has been independently developed or acquired by the Receiving Party without the aid, application or use of Confidential Information received from the Disclosing Party.

 

13.3 The Receiving Party shall have the right to disclose any Confidential Information provided hereunder if, in the reasonable opinion of the Receiving Party’s legal counsel, such disclosure is necessary to comply with the terms of this Agreement, or the requirements of any Applicable Law, but only to the extent of such necessity or requirements; and no such disclosure shall cause any such information to cease to be Confidential Information hereunder, except to the extent such disclosure results in a public disclosure of such information. Where reasonably possible under the requirements of any Applicable Law, the Receiving Party shall notify the Disclosing Party of the Receiving Party’s intent to make such disclosure of Confidential Information as soon as reasonably practicable prior to making such disclosure so as to allow the Disclosing Party adequate time to take whatever action the Disclosing Party may deem appropriate to protect the confidentiality of the information.

 

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13.4 Each Party agrees that it shall provide or permit access to Confidential Information received from the other Party only to the Receiving Party’s Affiliates, employees, officers, directors, consultants, advisors, and other permitted (actual and potential) subcontractors, Third Parties, (hereafter “Permitted Persons”), who have a need to know such Confidential Information to assist the Receiving Party with the activities contemplated or required of it by this Agreement, the Quality Agreement and/or the Safety Data Exchange Agreement and who are subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the Receiving Party pursuant to this Article 13; provided, that each Party shall remain responsible for any failure by any of its Permitted Persons to treat such Confidential Information as is required by this Article 13.

 

13.5 If this Agreement terminates or expires pursuant to Article 14, each Party shall promptly upon written request from the other Party, but no later than within thirty (30) days after such request, destroy or return at its own cost, all Confidential Information received from the other Party, and any copies thereof as well as notes, summaries or drawings containing Confidential Information (collectively the “Documentation”), shall cease any use of such Confidential Information except one copy of the Documentation may be retained solely for compliance purposes or for archive purposes, and shall make sure that any person or entity to whom Confidential Information has been disclosed or distributed by it or on its behalf does the same. In addition, each Party shall, upon the other Party’s request, confirm in writing that it does not retain and/or has destroyed all Documentation and has ceased to use the Confidential Information in any manner pursuant to this Section 13.5, except as permitted under this Agreement.

 

13.6 With Basilea’s prior approval, Cardiome may make scientific publications relating to the Product. Cardiome shall provide the proposed publication, presentation or other material intended for publication to Basilea in English, or, if the material is not in English, shall provide it in the original language together with an English summary forty-five (45) days prior to proposed submission for publication or presentation at conferences for Basilea’s review. Basilea shall advise Cardiome within twenty (20) days of receipt of such proposed material of its approval or any comments to such proposed publication and Cardiome shall comply with Basilea’s request to delete any references to Confidential Information supplied by Basilea, or shall withhold any presentation or publication for an additional period of time in order to permit Basilea to obtain patent protection prior to publication if Basilea deems it necessary.

 

13.7 It is understood and agreed that all “Confidential Information” under the Confidentiality Agreements entered between the Parties dated November 30, 2016 shall be deemed Confidential Information under this Agreement and be subject to this Article 13.

 

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ARTICLE 14 TERM; TERMINATION

 

14.1 Term of Agreement. The Agreement shall commence on the Effective Date and shall continue to be in force for […***…] from the Effective Date.

 

14.2 Termination for Cause. Either Party may terminate this Agreement immediately upon written notice to the other Party in the event of a material breach by the other Party of any term of this Agreement, which breach remains uncured for sixty (60) calendar days following written notice (the “Cure Period”). Notwithstanding the foregoing, if such material breach, by its nature, cannot be cured, the non-breaching Party may terminate this Agreement immediately upon written notice to the breaching Party.

 

14.3 Termination in Event of Insolvency. In the event that either Party (i) becomes insolvent, or institutes or has instituted against it a petition for bankruptcy or is adjudicated bankrupt; or (ii) executes a bill of sale, deed of trust, or a general assignment for the benefit of creditors; or (iii) is dissolved or transfers a substantial portion of its assets to a Third Party; or (iv) a receiver is appointed for the benefit of its creditors, or a receiver is appointed on account of insolvency (in any of (i)-(iv), such Party is the “Insolvent Party”), then the Insolvent Party shall immediately notify the other Party of such event and such other Party shall be entitled to: (a) terminate this Agreement for cause immediately upon written notice to the Insolvent Party; or (b) request that the Insolvent Party or its successor provide adequate assurances of continued and future performance in form and substance acceptable to such other Party, which shall be provided by the Insolvent Party within ten (10) calendar days of such request, and the other Party may terminate this Agreement for cause immediately upon written notice to the Insolvent Party in the event that the Insolvent Party fails to provide such assurances acceptable to the other Party within such ten (10) day period. For the sake of clarity, any asset transfer as a result of a Third Party acquiring Cardiome’s assets via a merger or acquisition, or the transfer of the Product to an entity acquired by Cardiome, shall not be considered an event with a Termination right.

 

14.4 Other Termination. This Agreement may be terminated on a country-by-country basis after the Cure Period as follows:

 

(a) by either Party pursuant to Section 17.5 (continuing force majeure);

 

(b) by Basilea pursuant to Section 2.6 (Non-compete);

 

(c) by Basilea pursuant to Section 10.4 (no challenge to IP);

 

(d) by Basilea if the First Commercial Sale Date in Italy, France, Germany and UK does not occur within the later of i) three months from the end of the Initial Transition Period or ii) six months from the Effective Date; or in the case of Spain, if the First Commercial Sale Date does not occur within nine months of the Effective Date. This Section 14.4 (d) shall not be applicable to the extent and for so long as the delay of the First Commercial Sale Date is due to causes which do not constitute force majeure but which are beyond Cardiome’s reasonable control and not due to its acts or omissions;

 

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(e) by Basilea if Cardiome ceases the majority of Commercialization activities for the Product after launch of the Product;

 

(f) by Basilea if Cardiome fails to achieve the Minimum Purchase Quantities for two consecutive calendar years; or

 

(g) by Cardiome in a particular country, if the Marketing Authorisation for the Product in that country is withdrawn, suspended or terminated.

 

For the avoidance of doubt, where the Agreement is only terminated on a country basis, the Parties’ rights and responsibilities shall only terminate in relation to such country and the provisions of the Agreement shall continue to apply in full force to all other countries.

 

14.5 Effect of Termination .

 

(a) Expiration or termination of the Agreement (including on a country basis) for whatever reason and regardless of the Party terminating shall result in:

 

(i) the Parties shall within thirty (30) days agree a transition plan including the operational details of the transition of activities from Cardiome to Basilea, (including continued supply to the end of any existing bid and tender agreements for up to one year after termination, it being understood that, if Cardiome has entered any such agreements with terms lasting more than one year, the Parties shall discuss in good faith how such obligations shall be met), after a reasonable transition period, to be agreed by the Parties, but in no event less than six (6) months;

 

(ii) Cardiome shall cooperate with Basilea to take necessary steps to transfer and assign all Authorisations, Know-how and Information related to the Product either to Basilea or its designee;

 

(iii) at the end of the transition period, all rights granted by Basilea to Cardiome under the Agreement shall terminate and revert to Basilea, all unconfirmed orders and supply obligations of Basilea shall terminate, Cardiome shall supply to Basilea all remaining stocks of any advertising and Cardiome Core Materials in connection with Commercialization of Product in the Territory, and Cardiome shall cease all use of the Dossier, Know-how and other Basilea Information supplied by Basilea hereunder.

 

(b) Cardiome shall notify Basilea of the amount of stock of Product held by it at the time of termination or expiration, and the amount subject to Customer orders. Basilea shall have the option (exercisable by written notice to Cardiome to be given not more than thirty (30) days after expiration or termination), either: (i) to inspect and repurchase from Cardiome at the Actual Transfer Price all of or any of stocks of the Product held by Cardiome which are not subject to orders from Customers and are in good and saleable condition; or (ii) permit Cardiome to Commercialize such stocks of Product, in accordance with all Applicable Law for a maximum period of six (6) months following the date of expiration or termination.

 

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(c) Termination of the Agreement shall be without prejudice to any rights that shall have accrued to the benefit of either Party before such termination.

 

(d) The termination or expiration of this Agreement shall not affect the survival and continuing validity of Article 9 (Representations and Warranties), Article 10 (Intellectual Property), Article 11 (Indemnification and Liability), Article 12 (Insurance), Article 15 (Records and Audits), Article 16 (Notices), Article 17 (Miscellaneous), or of any other provision which is expressly or by implication intended to continue in force after such termination or expiration.

 

ARTICLE 15 RECORDS AND AUDITS

 

15.1 Both Parties shall maintain complete and accurate Records of all matters relating to their performance that enable the other Party to demonstrate compliance with its obligations under this Agreement. Cardiome shall keep Records including normal business accounts which must be complete, accurate and in conformity with generally accepted accounting procedures (US GAAP or IAS) and that include a record of the sales or other disposition of the Product, any amounts paid to Basilea, and any amounts referenced in this Agreement. Both Parties’ Records shall be retained for no less than a six (6) year period following the year in which any such sale, distribution or payment occurred. Either Party may audit the other Party’s Records by an independent accountant nominated by and at auditing Party’s expense. The audited Party shall reasonably cooperate with such an accountant. Any audit shall be limited to the verification and determination of the correctness of the Records relating to the use or Commercialization of the Product or any amounts paid under this Agreement. All Records reviewed by the independent accountant shall be treated as Confidential Information. The audited Party shall be provided a copy of the audit within five (5) days of its conclusion. If the audit shows a sum is payable by one Party to the other, then this sum shall be paid within thirty (30) days. If the audit shows that the auditing Party has overpaid the audited Party, that Party shall apply this as a credit against future sums owing to it. This Article 15 shall survive the expiration or any termination of this Agreement for a period of two (2) years.

 

15.2 Provided reasonable notice has been given to the audited Party, the auditing Party may appoint qualified delegates to undertake an audit during normal working hours of the locations where the audited Party (or its Affiliates or authorised representatives) stores or has stored the Product, stock rotation, inventory and storage systems.

 

ARTICLE 16 NOTICES

 

16.1 Any notice required to be given hereunder shall be in writing and shall be deemed to have been sufficiently given: (i) when delivered in person, (ii) on the fifth business day after mailing by registered or certified mail, postage prepaid, return receipt requested, (iii) on the next business day after mailing by overnight courier service, or (iv) when delivered via facsimile with the original delivered via one of the preceding methods on or prior to the fifth business day after transmission of the facsimile, to the addresses specified below. Each notice shall specify the name and date of and Parties to this Agreement:

 

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If to Cardiome:

 

Correvio International Sàrl
Rue des Alpes 21
Case postale 1674
1201 Geneva, Switzerland
Attention: General Counsel

 

with a copy to:

 

Cardiome Pharma Corp.
1441 Creekside Drive
Floor Six
Vancouver, BC V6J4S7
Canada
Attention: General Counsel

 

If to Basilea:

 

Basilea Pharmaceutica International Ltd
Grenzacherstrasse 487, CH-4058,
Basel, Switzerland
Attention: Chief Commercial Officer

 

with a copy to:

 

Basilea Pharmaceutica International Ltd
Grenzacherstrasse 487, CH-4058,
Basel, Switzerland
Attention: Legal Department

 

16.2 Either Party may, by notice to the other Party, change the addresses and names given in Section 16.1.

 

ARTICLE 17 MISCELLANEOUS

 

17.1 Publicity .

 

(a) Neither Party shall issue any press release or other publicity materials, or make any presentation with respect to the existence of this Agreement or the terms and conditions hereof without the prior written consent of the other Party in each instance, unless such disclosures only repeats information disclosed previously following mutual written consents. This restriction shall not, however, apply to the extent that any such disclosures are required by Applicable Law, including as may be required in connection with any filings required to be made by the disclosure policies of a major stock exchange and a Party’s requirements to provide general guidance to financial analysts and investors related to the terms of the Agreement and Cardiome’s performance under this Agreement.

 

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(b) The Parties shall agree on a press release to be published upon the execution of this Agreement.

 

(c) Cardiome shall have no right to publish any papers, abstracts, summaries, materials for scientific communication or any other publications or make any presentation related to or based on information derived from performance under this Agreement without Basilea’s prior approval.

 

17.2 Choice of Law and Dispute Resolution by Arbitration .

 

(a) Choice of Law. This agreement shall be governed by, and construed in accordance with, the laws of Switzerland, without giving effect to its conflict of law provisions.

 

(b) Arbitration . The Parties recognize that disputes as to certain matters may from time to time arise during the Term that relate to the Party’s respective rights and/or obligations hereunder, including the validity, invalidity, or termination of this Agreement (“Dispute”). The Parties shall initially attempt in good faith to resolve any Dispute arising out of or relating to this Agreement by holding discussions between its executives. If no resolution is reached within thirty (30) days of the start of such discussion, then any Dispute, controversy or claim arising out of, or in relation to, this contract, including the validity, invalidity, breach, or termination thereof, shall be resolved by arbitration in accordance with the Swiss Rules of International Arbitration of the Swiss Chambers’ Arbitration Institution in force on the date on which the Notice of Arbitration is submitted in accordance with these Rules.

 

(i) The number of arbitrators shall be three.

 

(ii) The seat of the arbitration shall be Zurich, Switzerland.

 

(iii) The arbitral proceedings shall be conducted in English.

 

(c) This Section 17.2 shall be without prejudice to the right of either Party to seek injunctive or other preliminary judicial relief in any court of proper jurisdiction without attempting to resolve such Disputes as provided in this Section 17.2, if in a Party’s judgment such action is necessary to avoid irreparable harm. Further, the requirement to attempt in good faith to resolve Disputes in accordance with this Section 17.2 does not affect a Party’s right to terminate this Agreement as provided for herein, and neither Party shall be required to follow these procedures prior to terminating this Agreement, as the case may be.

 

17.3 Relationship of the Parties. The relationship hereby established between the Parties is solely that of independent contractors. Neither Party has any authority to act or make any agreements or representations on behalf of the other Party or its Affiliates. This Agreement is not intended to create, and shall not be construed as creating, between Basilea and Cardiome, the relationship of principal and agent, employer and employee, joint venturers, co-partners, or any other such relationship, the existence of which is expressly denied. No employee or agent engaged by one Party shall be, or shall be deemed to be, an employee or agent of the other Party and no such employee shall be entitled to any benefits that the other Party provides to its own employees.

 

  46  

CONFIDENTIAL

 

17.4 Assignment; Binding Effect; and Performance by Affiliates.

 

(a) Assignment by Cardiome. Cardiome shall have the right to assign this Agreement in whole to an Affiliate or to any successor to all of the business and assets of Cardiome, whether in a merger, consolidation, sale of stock, sale of assets or other similar transaction. Cardiome shall inform Basilea about such assignment as soon as reasonably possible. Apart from that Cardiome shall not assign, novate or otherwise transfer its rights or obligations hereunder without the prior written consent of Basilea, such consent not to be unreasonably withheld.

 

(b) Assignment by Basilea. Basilea shall have the right to assign this Agreement in whole or in part to an Affiliate or to any successor to all or substantially all of the business and assets of Basilea relevant to this Agreement, whether in a merger, consolidation, sale of stock, sale of assets or other similar transaction. Basilea shall inform Cardiome about such assignment as soon as reasonably possible. Basilea shall further have the right to assign this Agreement in whole or in part to a purchaser of the Product.

 

(c) Binding Effect of Delegation. Any delegation or subcontracting consented to by the other Party shall not relieve the subcontracting Party of its responsibilities and liabilities hereunder and the subcontracting Party shall remain liable to the other Party for the conduct and performance of each permitted delegate and subcontractor hereunder. This Agreement shall apply to, inure to the benefit of and be binding upon the Parties hereto and their respective successors and permitted assigns. The Parties agree that this Agreement is not intended by any Party to give any benefits, rights, privileges, actions or remedies to any person or entity, partnership, firm or corporation as a Third Party beneficiary or otherwise under any theory of law.

 

(d) Performance by Affiliates . Each Party may discharge any obligations and exercise any right hereunder through any of its Affiliates. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement, and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement shall be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.

 

  47  

CONFIDENTIAL

 

17.5 Force Majeure. No Party shall be liable for any failure to perform or any delays in performance, and no Party shall be deemed to be in breach or default of its obligations set forth in this Agreement, if, to the extent and for so long as, such failure or delay is due to any causes that are beyond its reasonable control and not to its acts or omissions, including, without limitation, such causes as acts of God, natural disasters, fire, flood, severe storm, earthquake, civil disturbance, lockout, riot, order of any court or administrative body, embargo, acts of government, war (whether or not declared), acts of terrorism, or other similar causes (each, a “Force Majeure Event”). For clarity, raw material price increases, unavailability of raw materials, and labor disputes shall not be deemed a Force Majeure Event. In the event of a Force Majeure Event, the Party prevented from or delayed in performing shall promptly give notice to the other Party and avoid or minimize the delay. In the event that the delay continues for a period of at least six (6) months, the Party affected by the other Party’s delay may elect to: (a) suspend performance and extend the time for performance for the duration of the Force Majeure Event, or (b) cancel the unperformed part of this Agreement and/or any Purchase Orders.

 

17.6 Severability. If and solely to the extent that any court or tribunal of competent jurisdiction holds any provision of this Agreement to be unenforceable in a final non-appealable order, such unenforceable provision shall be stricken and the remainder of this Agreement shall not be affected thereby. In such event, the Parties shall in good faith attempt to replace any unenforceable provision of this Agreement with a provision that is enforceable and that comes as close as possible to expressing the intention of the original provision.

 

17.7 Non-Waiver; Remedies. A waiver by any Party of any term or condition of this Agreement in any instance shall not be deemed or construed to be a waiver of such term or condition for the future, or of any subsequent breach thereof. All remedies specified in this Agreement shall be cumulative and in addition to any other remedies provided at law or in equity.

 

17.8 Further Documents. Each Party hereto agrees to execute such further documents and take such further steps as may be reasonably necessary or desirable to effectuate the purposes of this Agreement.

 

17.9 Forms. The Parties recognize that, during the Term of this Agreement, a purchase order acknowledgment form or similar routine document (collectively, “Forms”) may be used to implement or administer provisions of this Agreement. The Parties agree that the terms of this Agreement shall prevail in the event of any conflict between terms of this Agreement and the terms of such Forms, and any additional or different terms contained in such Forms shall not apply to this Agreement.

 

17.10 Headings. Headings of Sections or other parts of this Agreement are included herein for convenience of reference only and shall not constitute a part of this Agreement or change the meaning of this Agreement.

 

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CONFIDENTIAL

 

17.11 Counterparts. This Agreement may be executed in two or more counterparts, each of which shall constitute an original and all of which together shall constitute one and the same agreement and shall become effective when signed by each of the Parties hereto and delivered to the other Party in accordance with the means set forth in Article 16 or by reliable electronic means (with receipt electronically confirmed), followed by a prompt delivery of a signed counterpart.

 

17.12 Entire Agreement; Amendments. This Agreement, together with any attachments and amendments, constitutes the entire agreement of the Parties with respect to its subject matter and merges and supersedes all prior discussions and writings with respect to thereto. No modification or alteration of this Agreement shall be binding upon the Parties unless contained in writing signed by a duly authorized agent for each respective Party and specifically referring hereto or thereto. No representation, undertaking or promise shall be taken to have been given or be implied from anything said or written in negotiations between the Parties prior to this Agreement except as expressly stated in this Agreement. Neither Party shall have any remedy in respect of any untrue statement made by the other upon which that Party relied in entering into this Agreement (unless such untrue statement was made fraudulently) and that Party’s only remedies shall be for breach of contract as provided in this Agreement.

 

[Signatures on the next page]

 

  49  

CONFIDENTIAL

 

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly executed and delivered as of the date first written above.

 

Basilea Pharmaceutica International Ltd.   Correvio International Sàrl
     
By /s/ Ronald Scott   By /s/ David D. McMasters
Name: Ronald Scott   Name: David D. McMasters
Title: Chief Executive Officer   Title:   Director
Place/Date: Basel,   Place/Date:
         

Basilea Pharmaceutica International Ltd.   Correvio International Sàrl
     
By: /s/ Donato Spota   By
Name: Donato Spota   Name:
Title: Chief Financial Officer   Title:  Director
Place/Date: Basel   Place/Date:
       

  50  

 

Exhibit 4.2

 

Execution Version

 

 

 

SECOND AMENDED AND RESTATED TERM LOAN AGREEMENT

 

dated as of

 

May 15, 2018

 

between

 

CORREVIO PHARMA CORP. 

as Borrower,

 

The Subsidiary Guarantors from Time to Time Party Hereto,

 

The Lenders from Time to Time Party Hereto,

 

and

 

CRG SERVICING LLC

as Administrative and Collateral Agent

 

U.S. $50,000,000

 

 

 

i

 

 

TABLE OF CONTENTS

 

  Page
   
SECTION 1 DEFINITIONS 1
1.01 Certain Defined Terms 1
1.02 Accounting Terms and Principles 24
1.03 Interpretation 24
1.04 Quebec Interpretation Clause 24
1.05 Changes to GAAP 25
   
SECTION 2 THE COMMITMENT 26
2.01 Commitments 26
2.02 Borrowing Procedures 26
2.03 Fees 26
2.04 Use of Proceeds 26
2.05 Defaulting Lenders 27
2.06 Substitution of Lenders 28
2.07 Prior Borrowings 29
   
SECTION 3 PAYMENTS OF PRINCIPAL AND INTEREST 29
3.01 Repayment 29
3.02 Interest 29
3.03 Prepayments 30
   
SECTION 4 PAYMENTS, ETC. 33
4.01 Payments 33
4.02 Computations 33
4.03 Notices 33
4.04 Set-Off 33
4.05 Pro Rata Treatment 34
   
SECTION 5 YIELD PROTECTION, ETC. 35
5.01 Additional Costs 35
5.02 Illegality 36
5.03 Taxes 36
   
SECTION 6 CONDITIONS PRECEDENT 39
6.01 The First Borrowing 39
6.02 Conditions to Second Borrowing 43
6.03 Conditions to Third Borrowing 44
6.04 Conditions to Fourth Borrowing 45
6.05 Conditions to Each Borrowing 45
6.06 Conditions to the effectiveness of this Agreement 46

 

ii

 

 

TABLE OF CONTENTS

(continued)

 

  Page
   
SECTION 7 REPRESENTATIONS AND WARRANTIES 49
7.01 Power and Authority 49
7.02 Authorization; Enforceability 49
7.03 Governmental and Other Approvals; No Conflicts 49
7.04 Financial Statements; Material Adverse Change 50
7.05 Properties 50
7.06 No Actions or Proceedings 53
7.07 Compliance with Laws and Agreements 53
7.08 Taxes 54
7.09 Full Disclosure 54
7.10 Regulation 54
7.11 Solvency 54
7.12 Subsidiaries 54
7.13 Indebtedness and Liens 54
7.14 Material Agreements 55
7.15 Restrictive Agreements 55
7.16 Real Property 55
7.17 Pension Matters 56
7.18 Collateral; Security Interest 56
7.19 Regulatory Approvals 56
7.20 Canadian Pension or Benefit Plans 56
7.21 Series A Shares 56
7.22 The Toronto-Dominion Bank Account 56
   
SECTION 8 AFFIRMATIVE COVENANTS 57
8.01 Financial Statements and Other Information 57
8.02 Notices of Material Events 58
8.03 Existence; Conduct of Business 60
8.04 Payment of Taxes and Other Claims 60
8.05 Insurance 60
8.06 Books and Records; Inspection Rights 61
8.07 Compliance with Laws and Other Obligations 61
8.08 Maintenance of Properties, Etc. 61
8.09 Licenses 61
8.10 Action under Environmental Laws 62
8.11 Use of Proceeds 62
8.12 Certain Obligations Respecting Subsidiaries; Further Assurances 62
8.13 Termination of Non-Permitted Liens 63
8.14 Intellectual Property 64

 

iii

 

 

TABLE OF CONTENTS

(continued)

 

    Page
     
8.15 Owned Real Property 64
8.16 Update of Schedules 64
8.17 Post-Closing Items 64
8.18 Swiss Guarantors 64
8.19 Loan Proceeds 65
8.20 Cipher Transaction Proceeds 65
   
SECTION 9 NEGATIVE COVENANTS 65
9.01 Indebtedness 65
9.02 Liens 66
9.03 Fundamental Changes and Acquisitions 67
9.04 Lines of Business 68
9.05 Investments 68
9.06 Restricted Payments 69
9.07 Payments of Indebtedness 69
9.08 Change in Fiscal Year 69
9.09 Sales of Assets, Etc. 69
9.10 Transactions with Affiliates 70
9.11 Restrictive Agreements 70
9.12 Amendments to Material Agreements 70
9.13 Operating Leases 70
9.14 Sales and Leasebacks 71
9.15 Hazardous Material 71
9.16 Accounting Changes 71
9.17 Compliance with ERISA 71
9.18 Canadian Benefit Plans 71
9.19 [Reserved.] 71
9.20 Series A Shares 71
9.21 Swiss Indebtedness 71
   
SECTION 10 FINANCIAL COVENANTS 72
10.01 Minimum Liquidity 72
10.02 Minimum Revenue 72
10.03 Cure Right 72
   
SECTION 11 EVENTS OF DEFAULT 73
11.01 Events of Default 73
11.02 Remedies 76

 

iv

 

 

TABLE OF CONTENTS

(continued)

 

  Page
   
SECTION 12 ADMINISTRATIVE AGENT 77
12.01 Appointment and Duties 77
12.02 Duties as Collateral and Disbursing Agent 79
12.03 Binding Effect 79
12.04 Use of Discretion 79
12.05 Delegation of Rights and Duties 80
12.06 Reliance and Liability 80
12.07 Administrative Agent Individually 81
12.08 Lender Credit Decision 81
12.09 Expenses; Indemnities 81
12.10 Resignation of Administrative Agent 82
12.11 Release of Collateral or Guarantors 82
12.12 Additional Secured Parties 83
12.13 Quebec Security 83
12.14 French Security 84
   
SECTION 13 MISCELLANEOUS 84
13.01 No Waiver 84
13.02 Notices 85
13.03 Expenses, Indemnification, Etc. 85
13.04 Amendments, Etc. 86
13.05 Successors and Assigns 87
13.06 Survival 88
13.07 Captions 88
13.08 Counterparts 89
13.09 Governing Law 89
13.10 Jurisdiction, Service of Process and Venue 89
13.11 Waiver of Jury Trial 90
13.12 Waiver of Immunity 90
13.13 Entire Agreement 90
13.14 Severability 90
13.15 No Fiduciary Relationship 90
13.16 Confidentiality 90
13.17 USA PATRIOT Act 91
13.18 Maximum Rate of Interest 91
13.19 Certain Waivers 92
13.20 Judgment Currency 93
13.21 Limitations 93
13.22 Permitted Liens 93

 

v

 

 

TABLE OF CONTENTS

(continued)

 

    Page
     
13.23 Amendment and Restatement of the First A&R Agreement 93
13.24 English Guarantee and Security Confirmation 94
   
SECTION 14 GUARANTEE 95
14.01 The Guarantee 95
14.02 Obligations Unconditional 95
14.03 Reinstatement 96
14.04 Subrogation 96
14.05 Remedies 96
14.06 Instrument for the Payment of Money 96
14.07 Continuing Guarantee 96
14.08 Rights of Contribution 96
14.09 General Limitation on Guarantee Obligations 97
14.10 Joint and Several Obligations 97
14.11 Restricted Obligations – Switzerland 97
14.12 Restricted Obligations – Germany 99
14.13 Restricted Obligations – France 101
14.14 English Obligors 102

 

SCHEDULES AND EXHIBITS

 

Schedule 1    
Schedule 6.06    
Schedule 7.05(b)(i)    
Schedule 7.05(b)(ii)    
Schedule 7.05(c)    
Schedule 7.06    
Schedule 7.08    
Schedule 7.12    
Schedule 7.13(a)    
Schedule 7.13(b)    
Schedule 7.14    
Schedule 7.15    
Schedule 7.16    
Schedule 7.17    
Schedule 9.05    
Schedule 9.10    
Schedule 9.14    
     
Exhibit A    
Exhibit B    
Exhibit C    
Exhibit D    

 

vi

 

 

TABLE OF CONTENTS

(continued)

 

    Page

 

Exhibit E    
Exhibit F    
Exhibit G    

 

vii

 

 

SECOND AMENDED AND RESTATED TERM LOAN AGREEMENT, dated as of May 15, 2018 (this “ Agreement ”), among CORREVIO PHARMA CORP., a corporation incorporated pursuant to the federal laws of Canada (“ Borrower ”), the Subsidiary Guarantors from time to time party hereto, the Lenders from time to time party hereto and CRG SERVICING LLC, a Delaware limited liability company (“ CRG Servicing ”), as administrative and collateral agent for the Lenders (in such capacities, together with its successors and assigns, “ Administrative Agent ”).

 

WITNESSETH:

 

Cardiome Pharma Corp., a corporation incorporated pursuant to the federal laws of Canada (“ Original Borrower ”), the Subsidiary Guarantors and the Administrative Agent were parties to that certain term loan agreement dated as of June 13, 2016 (the “ Original Agreement ”), pursuant to which the Lenders made available certain loan facilities to the Original Borrower;

 

Original Borrower, the Subsidiary Guarantors and the Administrative Agent are parties to that certain amended and restated term loan agreement dated as of May 11, 2017 as amended by a first amending agreement dated as of March 27, 2018 (the “ First A&R Agreement ”), pursuant to which the Original Agreement was amended and restated in its entirety to allow for additional loans to be made available to the Original Borrower pursuant to the terms thereof;

 

Original Borrower, Borrower, the Subsidiary Guarantors and the Administrative Agent entered into that certain Assignment, Assumption and Confirmation Agreement dated as of the Closing Date (the “ Assignment Agreement ”), pursuant to which the Original Borrower assigned to the Borrower all of its rights and obligations under the First A&R Agreement and the other Loan Documents to which the Original Borrower was party, and the Borrower assumed all of the rights and obligations of the Original Borrower under the First A&R Agreement and the other Loan Documents to which the Original Borrower was a Party, and the Subsidiary Guarantors confirmed their respective obligations under the First A&R Agreement and each of the other Loan Documents to which each such Subsidiary Guarantor was a party; and

 

Borrower has requested that the First A&R Agreement be amended and restated in its entirety pursuant to the terms hereof, and the Lenders are prepared to amend and restate the Original Agreement on and subject to the terms and conditions hereof (it being agreed that this Agreement shall not constitute a novation of the obligations and liabilities of the parties under the First A&R Agreement or be deemed to evidence or constitute full repayment of such obligations and liabilities, but that this Agreement amends and restates in its entirety the First A&R Agreement and re-evidences the obligations and liabilities of the Borrower outstanding thereunder, which shall be payable in accordance with the terms hereof).

 

Accordingly, the parties agree as follows:

 

SECTION 1

DEFINITIONS

 

1.01      Certain Defined Terms . As used herein, the following terms have the following respective meanings:

 

  1  

 

 

10-Non-Qualifying Bank Creditor Rule ” means the rule that the aggregate number of creditors (other than Qualifying Bank Creditors) of the Swiss Guarantors under the Loan Documents must not exceed ten (10).

 

20-Non-Qualifying Bank Creditor Rule ” means the rule that the aggregate number of creditors (including the Lenders and the Participants), other than Qualifying Bank Creditors and related entities (provided that, the annual accounts of such related entities are fully consolidated at the level of the group as per recognized accounting standards) of a Swiss Guarantor, under all outstanding debts relevant for classification by the Swiss Federal Tax Administration as debenture ( Kassenobligation ), such as facilities and/or private placements (including with respect to the proceeds of the Loans that are on-lent to such Swiss Guarantor from time to time) must not at any time exceed twenty (20).

 

Accounting Change Notice ” has the meaning set forth in Section 1.05(a) .

 

Act ” has the meaning set forth in Section 13.17 .

 

Acquisition ” means any transaction, or any series of related transactions, by which any Person directly or indirectly, by means of a take-over bid, tender offer, amalgamation, merger, purchase of assets, or similar transaction having the same effect as any of the foregoing, (a) acquires any business or product, or all or substantially all of the assets of any Person engaged in any business, (b) acquires control of securities of a Person engaged in a business representing more than 50% of the ordinary voting power for the election of directors or other governing body if the business affairs of such Person are managed by a board of directors or other governing body, or (c) acquires control of more than 50% of the ownership interest in any Person engaged in any business that is not managed by a board of directors or other governing body.

 

Affected Lender ” has the meaning set forth in Section 2.06(a) .

 

Affiliate ” means, with respect to a specified Person, another Person that directly, or indirectly through one or more intermediaries, Controls or is Controlled by or is under common Control with the Person specified.

 

Agreement ” has the meaning set forth in the introduction hereto.

 

Asset Sale ” has the meaning set forth in Section 9.09 .

 

Asset Sale Net Proceeds ” means the aggregate amount of the cash proceeds received from any Asset Sale, net of any bona fide costs incurred in connection with such Asset Sale, plus, with respect to any non-cash proceeds of an Asset Sale, the fair market value of such non cash proceeds as determined by the Majority Lenders, acting reasonably.

 

Assignment Agreement ” has the meaning set forth in the introduction hereto.

 

Assignment and Assumption ” means an assignment and assumption entered into by a Lender and an assignee of such Lender.

 

Backend Facility Fee has the meaning given to such term in the Fee Letter.

 

  2  

 

 

Bankruptcy Code ” means Title II of the United States Code entitled “Bankruptcy.”

 

Benefit Plan ” means any employee benefit plan as defined in Section 3(3) of ERISA (whether governed by the laws of the United States or otherwise) to which any Obligor or Subsidiary thereof incurs or otherwise has any obligation or liability, contingent or otherwise.

 

Borrower ” has the meaning set forth in the introduction hereto.

 

Borrower Facility ” means the premises located at Suite 600, 6 th floor, 1441 Creekside Drive, Vancouver, British Columbia, which are leased by Borrower pursuant to the Borrower Lease.

 

Borrower Landlord ” means Central 1 Credit Union.

 

Borrower Lease ” means the office lease dated July 23, 2014 by and between the Original Borrower (and subsequently assigned to the Borrower) and Borrower Landlord in respect of the Borrower Facility.

 

Borrower Party ” has the meaning set forth in Section 13.03(b) .

 

Borrowing ” means a borrowing consisting of Loans made on the same day by the Lenders according to their respective Commitments (including, without limitation, a borrowing of a PIK Loan).

 

Borrowing Date ” means the date of a Borrowing including, for certainty, the initial Borrowing made on June 14, 2016, the second Borrowing made on May 11, 2017 and the third Borrowing made on August 8, 2017.

 

Borrowing Notice Date ” means, (a) in the case of the second Borrowing, a date that is at least twelve Business Days prior to the Borrowing Date of such Borrowing and, (b) in the case of a subsequent Borrowing, a date that is at least twenty Business Days prior to the Borrowing Date of such Borrowing.

 

Business Day ” means a day (other than a Saturday or Sunday) on which commercial banks are not authorized or required to close in New York City or Vancouver, British Columbia.

 

Canadian Benefit Plans ” means all Canadian (including without limitation any Canadian provincial or territorial) plans, arrangements, agreements, programs, policies, practices or undertakings, whether oral or written, formal or informal, funded or unfunded, insured or uninsured, registered or unregistered, subject to the laws of Canada or any province or territory thereof to which an Obligor or any of its Subsidiaries is a party or bound or in which their employees participate or under which an Obligor or any of its Subsidiaries has, or will have, any liability or contingent liability, or pursuant to which payments are made, or benefits are provided to, or an entitlement to payments or benefits may arise with respect to, any of their employees or former employees, their directors or officers, individuals working on contract with an Obligor or any of its Subsidiaries or other individuals providing services to an Obligor or any of its Subsidiaries of a kind normally provided by employees (or any spouses, dependents, survivors or beneficiaries of any such persons).

 

  3  

 

 

Canadian Insolvency Legislation ” means the Bankruptcy and Insolvency Act (Canada), the Companies’ Creditors Arrangement Act (Canada), the Winding-up and Restructuring Act (Canada) or any other bankruptcy, insolvency or analogous law of Canada.

 

Canadian Pension Plans ” means all Canadian Benefit Plans which are required to be registered under Canadian provincial, territorial or federal pension benefits standards legislation.

 

Canadian Security Agreement ” means the Amended and Restated Canadian Security Agreement, dated as of the Closing Date, among the Borrower, the other grantors from time to time party thereto and Administrative Agent.

 

Canadian Security Documents ” means the Canadian Security Agreement, each Canadian Short-Form IP Security Agreement, the Landlord Consent and any other agreement governed by Canadian law that creates or purports to create security and that is entered into by a Canadian Obligor pursuant to this Agreement (as such agreement may be amended, restated, replaced, supplemented or otherwise modified from time to time).

 

Canadian Short-Form IP Security Agreement ” means the amended and restated (if applicable) short-form copyright, patent or trademark (as the case may be) security agreements governed by the laws of any province or territory of Canada, dated as of the Original Closing Date or the Closing Date, as the case may be, entered into by one or more Obligors in favor of the Secured Parties, each in form and substance satisfactory to the Majority Lenders (as such agreement may be amended, restated, replaced, supplemented or otherwise modified from time to time).

 

Capital Lease Obligations ” means, as to any Person, the obligations of such Person to pay rent or other amounts under a lease of (or other agreement conveying the right to use) real and/or personal Property which obligations are required to be classified and accounted for as a capital lease on a balance sheet of such Person under GAAP and, for purposes of this Agreement, the amount of such obligations shall be the capitalized amount thereof, determined in accordance with GAAP.

 

Change of Control ” means (a) the acquisition of ownership, directly or indirectly, beneficially or of record, by any Person or group of Persons acting jointly or otherwise in concert of capital stock representing (i) in the case of the Borrower, more than 30% of the aggregate ordinary voting power represented by the issued and outstanding capital stock of the Borrower or (ii) in the case of a Subsidiary Guarantor, any of the ordinary voting power represented by the issued and outstanding capital stock of such Subsidiary Guarantor, (b) during any period of twelve (12) consecutive calendar months, the occupation of a majority of the seats (other than vacant seats) on the board of directors of the Borrower or any Subsidiary Guarantor by Persons who were neither (i) nominated by the board of directors of the Borrower or any Subsidiary Guarantor, as applicable, nor (ii) appointed by directors so nominated, or (c) the acquisition of direct or indirect Control of the Borrower or any Subsidiary Guarantor, as applicable, by any Person or group of Persons acting jointly or otherwise in concert; in each case whether as a result of a tender or exchange offer, open market purchases, privately negotiated purchases or otherwise.

 

  4  

 

 

Cipher Transaction ” means the purchase of all the outstanding shares of the Original Borrower pursuant to and on the terms and conditions of the arrangement agreement dated as of March 19, 2018 among Cipher Pharmaceuticals Inc., the Original Borrower and the Borrower.

 

Claims ” means any claims, demands, complaints, grievances, actions, applications, suits, causes of action, orders, charges, indictments, prosecutions, informations (brought by a public prosecutor without grand jury indictment) or other similar processes, assessments or reassessments.

 

Closing Date ” means May 15, 2018.

 

Code ” means the Internal Revenue Code of 1986, as amended from time to time, and the rules and regulations promulgated thereunder from time to time.

 

Collateral ” means any Property in which a Lien is purported to be granted under any of the Security Documents (or all such Property, as the context may require).

 

Commitment ” means, with respect to each Lender, the obligation of such Lender to make Loans to Borrower in accordance with the terms and conditions of this Agreement, which commitment is in the amount set forth opposite such Lender’s name on Schedule 1 under the caption “Commitment”, as such Schedule may be amended from time to time. The aggregate Commitments on the date hereof equal $50,000,000. For purposes of clarification, the amount of any PIK Loans shall not reduce the amount of the available Commitment.

 

Commitment Period ” means the period from and including the Original Closing Date and through and including March 31, 2018 or such later date as the Administrative Agent agrees to in writing in its sole discretion.

 

Commodity Account ” has the meaning set forth in the U.S. Security Agreement.

 

Compliance Certificate ” has the meaning given to such term in Section 8.01(d) .

 

Contracts ” means contracts, licenses, leases, agreements, obligations, promises, undertakings, understandings, arrangements, documents, commitments, entitlements or engagements under which a Person has, or will have, any liability or contingent liability (in each case, whether written or oral, express or implied).

 

Control ” means, in respect of a particular Person, the possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of such Person, whether through the ability to exercise voting power, by contract or otherwise. “Controlling” and “Controlled” have meanings correlative thereto.

 

Copyright ” has the meaning set forth in the Canadian Security Agreement.

 

Cure Amount ” has the meaning set forth in Section 10.03(a) .

 

Cure Right ” has the meaning set forth in Section 10.03(a) .

 

Default ” means any Event of Default and any event that, upon the giving of notice, the lapse of time or both, would constitute an Event of Default.

 

  5  

 

 

Default Rate ” has the meaning set forth in Section 3.02(b) .

 

Defaulting Lender ” means, subject to Section 2.05 , any Lender that (a) has failed to perform any of its funding obligations hereunder, including in respect of its Loans, within three (3) Business Days of the date required to be funded by it hereunder, (b) has notified Borrower or any Lender that it does not intend to comply with its funding obligations or has made a public statement to that effect with respect to its funding obligations hereunder or under other agreements in which it commits to extend credit, or (c) has, or has a direct or indirect parent company that has, (i) become the subject of an Insolvency Proceeding, (ii) had a receiver, conservator, trustee, administrator, assignee for the benefit of creditors or similar Person charged with reorganization or liquidation of its business or a custodian appointed for it, or (iii) taken any action in furtherance of, or indicated its consent to, approval of or acquiescence in any such proceeding or appointment; provided that a Lender shall not be a Defaulting Lender solely by virtue of the ownership or acquisition of any equity interest in that Lender or any direct or indirect parent company thereof by a Governmental Authority.

 

Deposit Account ” is defined in the Canadian Security Agreement.

 

Dollars ” and “ $ ” means lawful money of the United States of America.

 

Domestic Subsidiary ” means any Subsidiary that is a corporation, limited liability company, unlimited liability company, partnership or similar business entity incorporated, formed or organized under the laws of the United States, any state of the United States, the District of Columbia, the laws of Canada or any province or territory of Canada.

 

Eligible Transferee ” means and includes a commercial bank, an insurance company, a finance company, a financial institution, any investment fund that invests in loans or any other “accredited investor” (as defined in Regulation D of the Securities Act) that is principally in the business of managing investments or holding assets for investment purposes, provided that each Eligible Transferee shall either (i) be a Qualifying Bank Creditor or (ii) not cause the number of existing Lenders and Participants (directly or indirectly) hereunder which are not, in each case, Qualifying Bank Creditors to exceed in aggregate ten (10).

 

English Debenture ” means the composite debenture between the English Obligors and the Administrative Agent dated the date of the Original Agreement.

 

English Guarantee ” means the composite guarantee between the English Obligors and the Administrative Agent dated the date of the Original Agreement.

 

English Obligors ” means Cardiome UK Limited (company number 06304464) and Correvio (UK) Ltd. (company number 06481819) both having their registered addresses at Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, England UB11 1BD.

 

English Security Documents ” means the English Debenture, the English Share Charges and any other agreement governed by English law that creates or purports to create security and that is entered into by either of the English Obligors pursuant to this Agreement (as any such agreement may be amended, restated, replaced, supplemented or otherwise modified from time to time).

 

  6  

 

 

English Share Charges ” means each of:

 

1. the share charge between Cardiome International SA and the Administrative Agent over the shares in Correvio (UK) Ltd. dated the Closing Date; and

 

2. the share charge between the Borrower and the Administrative Agent over the shares in Cardiome UK Limited dated the Closing Date.

 

Environmental Law ” means any federal, state, provincial, territorial or local governmental law, rule, regulation, order, writ, judgment, injunction or decree relating to pollution or protection of the environment or the treatment, storage, disposal, release, threatened release or handling of hazardous materials, and all local laws and regulations related to environmental matters and any specific agreements entered into with any competent authorities which include commitments related to environmental matters.

 

Equity Cure Right ” has the meaning set forth in Section 10.03(a) .

 

Equity Interest ” means, with respect to any Person, any and all shares, interests, participations or other equivalents, including membership interests (however designated, whether voting or nonvoting), of equity of such Person, including, if such Person is a partnership, partnership interests (whether general or limited) and any other interest or participation that confers on a Person the right to receive a share of the profits and losses of, or distributions of property of, such partnership, but excluding debt securities convertible or exchangeable into such equity.

 

Equivalent Amount ” means, with respect to an amount denominated in one currency, the amount in another currency that could be purchased by the amount in the first currency determined by reference to the Exchange Rate at the time of determination.

 

ERISA ” means the United States Employee Retirement Income Security Act of 1974, as amended.

 

ERISA Affiliate ” means, collectively, any Obligor, Subsidiary thereof, and any Person under common control, or treated as a single employer, with any Obligor or Subsidiary thereof, within the meaning of Section 414(b), (c), (m) or (o) of the Code.

 

  7  

 

 

ERISA Event ” means (a) a reportable event as defined in Section 4043 of ERISA with respect to a Title IV Plan, excluding, however, such events as to which the PBGC by regulation has waived the requirement of Section 4043(a) of ERISA that it be notified within 30 days of the occurrence of such event; (b) the applicability of the requirements of Section 4043(b) of ERISA with respect to a contributing sponsor, as defined in Section 4001(a)(13) of ERISA, to any Title IV Plan where an event described in paragraph (9), (10), (11), (12) or (13) of Section 4043(c) of ERISA is reasonably expected to occur with respect to such plan within the following 30 days; (c) a withdrawal by any Obligor or any ERISA Affiliate thereof from a Title IV Plan or the termination of any Title IV Plan resulting in liability under Sections 4063 or 4064 of ERISA; (d) the withdrawal of any Obligor or any ERISA Affiliate thereof in a complete or partial withdrawal (within the meaning of Section 4203 and 4205 of ERISA) from any Multiemployer Plan if there is any potential liability therefore, or the receipt by any Obligor or any ERISA Affiliate thereof of notice from any Multiemployer Plan that it is in reorganization or insolvency pursuant to Section 4241 or 4245 of ERISA; (e) the filing of a notice of intent to terminate, the treatment of a plan amendment as a termination under Section 4041 or 4041A of ERISA, or the commencement of proceedings by the PBGC to terminate a Title IV Plan or Multiemployer Plan; (f) the imposition of liability on any Obligor or any ERISA Affiliate thereof pursuant to Sections 4062(e) or 4069 of ERISA or by reason of the application of Section 4212(c) of ERISA; (g) the failure by any Obligor or any ERISA Affiliate thereof to make any required contribution to a Plan, or the failure to meet the minimum funding standard of Section 412 of the Code with respect to any Title IV Plan (whether or not waived in accordance with Section 412(c) of the Code) or the failure to make by its due date a required installment under Section 430 of the Code with respect to any Title IV Plan or the failure to make any required contribution to a Multiemployer Plan; (h) the determination that any Title IV Plan is considered an at-risk plan or a plan in endangered to critical status within the meaning of Sections 430, 431 and 432 of the Code or Sections 303, 304 and 305 of ERISA; (i) an event or condition which is reasonably likely to constitute grounds under Section 4042 of ERISA for the termination of, or the appointment of a trustee to administer, any Title IV Plan or Multiemployer Plan; (x) the imposition of any liability under Title I or Title IV of ERISA, other than PBGC premiums due but not delinquent under Section 4007 of ERISA, upon any Obligor or any ERISA Affiliate thereof; (j) an application for a funding waiver under Section 303 of ERISA or an extension of any amortization period pursuant to Section 412 of the Code with respect to any Title IV Plan; (k) the occurrence of a non-exempt prohibited transaction under Sections 406 or 407 of ERISA for which any Obligor or any Subsidiary thereof may be directly or indirectly liable; (l) a violation of the applicable requirements of Section 404 or 405 of ERISA or the exclusive benefit rule under Section 401(a) of the Code by any fiduciary or disqualified person for which any Obligor or any ERISA Affiliate thereof may be directly or indirectly liable; (m) the occurrence of an act or omission which could give rise to the imposition on any Obligor or any ERISA Affiliate thereof of fines, penalties, taxes or related charges under Chapter 43 of the Code or under Sections 409, 502(c), (i) or (1) or 4071 of ERISA; (n) the assertion of a material claim (other than routine claims for benefits) against any Plan or the assets thereof, or against any Obligor or any Subsidiary thereof in connection with any such plan; (o) receipt from the IRS of notice of the failure of any Qualified Plan to qualify under Section 401(a) of the Code, or the failure of any trust forming part of any Qualified Plan to fail to qualify for exemption from taxation under Section 501(a) of the Code; (p) the imposition of any lien (or the fulfillment of the conditions for the imposition of any lien) on any of the rights, properties or assets of any Obligor or any ERISA Affiliate thereof, in either case pursuant to Title I or IV, including Section 302(f) or 303(k) of ERISA or to Section 401(a)(29) or 430(k) of the Code; or (q) the establishment or amendment by any Obligor or any Subsidiary thereof of any “welfare plan”, as such term is defined in Section 3(1) of ERISA, that provides post-employment welfare benefits in a manner that would materially increase the liability of any Obligor.

 

ERISA Funding Rules ” means the rules regarding minimum required contributions (including any installment payment thereof) to Title IV Plans, as set forth in Sections 412, 430, 431, 432 and 436 of the Code and Sections 302, 303, 304 and 305 of ERISA.

 

Escrow Account ” means the “Escrow Fund” (as defined in the Murk Stock and Asset Purchase Agreement) established pursuant to the terms and conditions of the Murk Stock and Asset Purchase Agreement which includes an obligation of Borrower to maintain a minimum balance of $1,000,000 in such “Escrow Fund” at all times.

 

  8  

 

 

Event of Default ” has the meaning set forth in Section 11.01 .

 

Exchange Rate ” means the rate at which any currency (the “ Pre-Exchange Currency ”) may be exchanged into another currency (the “ Post-Exchange Currency ”), as set forth on such date on the relevant Reuters screen at or about 11:00 a.m. (Central time) on such date. In the event that such rate does not appear on the Reuters screen, the “Exchange Rate” with respect to exchanging such Pre-Exchange Currency into such Post-Exchange Currency shall be determined by reference to such other publicly available service for displaying exchange rates as may be agreed upon by Borrower and Administrative Agent or, in the absence of such agreement, such Exchange Rate shall instead be determined by Administrative Agent by any reasonable method as they deem applicable to determine such rate, and such determination shall be conclusive absent manifest error.

 

Excluded Taxes ” means any of the following Taxes imposed on or with respect to a Recipient or required to be withheld or deducted from a payment to a Recipient: (a) Taxes imposed on or measured by net income (however denominated), franchise Taxes and branch profits Taxes, in each case imposed as a result of such Recipient being organized under the laws of, or having its principal office or, in the case of any Lender, its applicable lending office located in, the jurisdiction imposing such Tax, (b) Other Connection Taxes, (c) United States federal withholding Taxes that are imposed on amounts payable to a Lender to the extent that the obligation to withhold amounts existed on the date that such Lender became a “Lender” under this Agreement, except in each case to the extent such Lender is a direct or indirect assignee of any other Lender that was entitled, at the time the assignment of such other Lender became effective, to receive additional amounts under Section 5.03 , (d) any Taxes imposed in connection with FATCA, (e) any Canadian federal withholding Taxes imposed on the payment as a result of having been made to a Recipient that, at the time of making such payment, (i) is a person with which an Obligor does not deal at arm’s length (for the purposes of the Income Tax Act (Canada)), or (ii) is a “specified shareholder” (as defined in subsection 18(5) of the Income Tax Act (Canada)) of an Obligor or does not deal at arm’s length (for the purposes of the Income Tax Act (Canada)) with such a “specified shareholder” (other than where the non-arm’s length relationship arises, or where the Recipient is a “specified shareholder” or does not deal at arm’s length with a “specified shareholder”, in connection with or as a result of the Recipient having become a party to, received or perfected a security interest under or received or enforced any rights under, a Loan Document), and (f) Taxes attributable to such Recipient’s failure to comply with Section 5.03(e) .

 

FATCA ” means Sections 1471 through 1474 of the Code, as of the date of this Agreement (or any amended or successor version that is substantively comparable and not more onerous to comply with), any regulations or official interpretations thereof and any agreements entered into pursuant to Section 1471(b)(1) of the Code.

 

Federal Funds Effective Rate ” means, for any day, the weighted average of the rates on overnight federal funds transactions with members of the Federal Reserve System arranged by federal funds brokers, as published on the next succeeding Business Day by the Federal Reserve Bank of New York, or, if such rate is not so published for any day that is a Business Day, the average of the quotations for the day of such transactions received by Administrative Agent from three federal funds brokers of recognized standing selected by it.

 

  9  

 

 

Fee Letter ” means the second amended and restated fee letter agreement dated as of the date hereof between Borrower and Administrative Agent.

 

First Amendment ” means the First Amending Agreement to the First A&R Agreement dated as of March 27, 2018.

 

First A&R Agreement ” has the meaning set forth in the introduction hereto.

 

First Restatement Date ” means May 11, 2017.

 

Foreign Lender ” means a Lender that is not a U.S. Person.

 

Foreign Subsidiary ” means a Subsidiary of Borrower that is not a Domestic Subsidiary.

 

Fourth Borrowing Milestone ” has the meaning set forth in Section 6.04(c) .

 

French Security Documents ” has the meaning given to such term in Section 12.14 .

 

French Subsidiary Guarantor ” means any Subsidiary Guarantor incorporated or established in France.

 

GAAP ” means generally accepted accounting principles in the United States of America, as in effect from time to time, set forth in the opinions and pronouncements of the Accounting Principles Board and the American Institute of Certified Public Accountants, in the statements and pronouncements of the Financial Accounting Standards Board and in such other statements by such other entity as may be in general use by significant segments of the accounting profession that are applicable to the circumstances as of the date of determination. Subject to Section 1.02 , all references to “GAAP” shall be to GAAP applied consistently with the principles used in the preparation of the financial statements described in Section 7.04(a) .

 

German Account Pledge Agreement s” means (i) the German law governed account Pledge Agreement dated as of the date of the Original Agreement and (ii) the German law governed confirmation and junior ranking account pledge agreement dated on or around the date of this Agreement, in each case entered into between, among others, Correvio GmbH as pledgor and the Administrative Agent.

 

German Confirmation Agreement – First Restatement ” means the German law governed confirmation agreement dated on or around the First Restatement Date and relating to (i) the German Security Assignment Agreement and (ii) the German Security Trust Agreement.

 

German Confirmation Agreement – Second Restatement ” means the German law governed confirmation agreement dated on or around the Closing Date and relating to (i) the German Security Assignment Agreement and (ii) the German Security Trust Agreement.

 

German Security Documents ” means the German Share Pledge Agreements, the German Security Assignment Agreement, the German Account Pledge Agreements, the German Confirmation Agreement – First Restatement, the German Confirmation Agreement – Second Restatement and any other agreement governed by German law that creates or purports to create security and that is entered into by a German Obligor pursuant to this Agreement.

 

  10  

 

 

German Security Assignment Agreement ” means the German law governed security assignment agreement dated the date of the Original Agreement entered into between, among others, Correvio GmbH as assignor and the Administrative Agent as collateral agent (as such agreement may be amended, restated, replaced, supplemented or otherwise modified from time to time).

 

German Security Trust Agreement ” means the German law governed security trust agreement dated the date of the Original Agreement entered into between, among others, Correvio GmbH and Correvio International Sàrl as security grantors and the Administrative Agent, under which the Administrative Agent has been granted certain rights and has assumed certain obligations in relation to the German Security Documents (as such agreement may be amended, restated, replaced, supplemented or otherwise modified from time to time).

 

German Share Pledge Agreements ” means (i) the German law governed share pledge agreement dated the date of the Original Agreement and (ii) the German law governed junior ranking share pledge agreement dated on or around the First Restatement Date, in each case entered into between, among others, Correvio International Sàrl as pledgor and the Administrative Agent.

 

Governmental Approval ” means any consent, authorization, approval, order, license, franchise, permit, certificate, accreditation, registration, filing or notice, of, issued by, from or to, or other act by or in respect of, any Governmental Authority.

 

Governmental Authority ” means any nation, government, branch of power (whether executive, legislative or judicial), state, province, territory or municipality or other political subdivision thereof and any entity exercising executive, legislative, judicial, monetary, regulatory or administrative functions of or pertaining to government, including without limitation regulatory authorities, governmental departments, agencies, commissions, bureaus, officials, ministers, courts, bodies, boards, tribunals and dispute settlement panels, and other law-, rule- or regulation-making organizations or entities of any state, province, territory, county, city or other political subdivision of the United States or Canada.

 

Guarantee ” of or by any Person (the “ guarantor ”) means any obligation, contingent or otherwise, of the guarantor guaranteeing or having the economic effect of guaranteeing any Indebtedness or other obligation of any other Person (the “ primary obligor ”) in any manner, whether directly or indirectly, and including any obligation of the guarantor, direct or indirect, (a) to purchase or pay (or advance or supply funds for the purchase or payment of) such Indebtedness or other obligation or to purchase (or to advance or supply funds for the purchase of) any security for the payment thereof, (b) to purchase or lease property, securities or services for the purpose of assuring the owner of such Indebtedness or other obligation of the payment thereof, (c) to maintain working capital, equity capital or any other financial statement condition or liquidity of the primary obligor so as to enable the primary obligor to pay such Indebtedness or other obligation or (d) as an account party in respect of any letter of credit or letter of guaranty issued to support such Indebtedness or obligation; provided, that the term Guarantee shall not include endorsements for collection or deposit in the ordinary course of business.

 

Guarantee Assumption Agreement ” means a Guarantee Assumption Agreement substantially in the form of Exhibit A by an entity that, pursuant to Section 8.12(a) , is required to become a “Subsidiary Guarantor” hereunder.

 

  11  

 

 

Guaranteed Obligations ” has the meaning set forth in Section 14.01 .

 

Hazardous Material ” means any substance, element, chemical, compound, product, solid, gas, liquid, waste, by- product, pollutant, contaminant or material which is hazardous or toxic, and includes, without limitation, (a) asbestos, polychlorinated biphenyls and petroleum (including crude oil or any fraction thereof) and (b) any material classified or regulated as “hazardous” or “toxic” or words of like import pursuant to an Environmental Law.

 

Hedging Agreement ” means any interest rate exchange agreement, foreign currency exchange agreement, commodity price protection agreement or other interest or currency exchange rate or commodity price hedging arrangement.

 

Indebtedness ” of any Person means, without duplication, (a) all obligations of such Person for borrowed money or obligations of such Person with respect to deposits or advances of any kind by third parties, (b) all obligations of such Person evidenced by bonds, debentures, notes or similar instruments, (c) all obligations of such Person upon which interest charges are customarily paid, (d) all obligations of such Person under conditional sale or other title retention agreements relating to property acquired by such Person, (e) all obligations of such Person in respect of the deferred purchase price of property or services (excluding current accounts payable incurred in the ordinary course of business), (f) all Indebtedness of others secured by (or for which the holder of such Indebtedness has an existing right, contingent or otherwise, to be secured by) any Lien on property owned or acquired by such Person, whether or not the Indebtedness secured thereby has been assumed, (g) all Guarantees by such Person of Indebtedness of others, (h) all Capital Lease Obligations of such Person, (i) all obligations, contingent or otherwise, of such Person as an account party in respect of letters of credit and letters of guaranty, (j) obligations under any Hedging Agreement, currency swaps, forwards, futures or derivatives transactions, (k) all obligations, contingent or otherwise, of such Person in respect of bankers’ acceptances, (l) all obligations of such Person under license or other agreements containing a guaranteed minimum payment or purchase by such Person, and (m) all Equity Interests of such Person subject to repurchase or redemption rights or obligations (excluding repurchases or redemptions at the sole option of such Person). The Indebtedness of any Person shall include the Indebtedness of any other entity (including any partnership in which such Person is a general partner) to the extent such Person is liable therefor as a result of such Person’s ownership interest in or other relationship with such entity, except to the extent the terms of such Indebtedness provide that such Person is not liable therefor.

 

Indemnified Party ” has the meaning set forth in Section 13.03(b) .

 

Indemnified Taxes ” means (a) Taxes, other than Excluded Taxes, imposed on or with respect to any payment made by or on account of any Obligation and (b) to the extent not otherwise described in clause (a), Other Taxes.

 

Insolvency Proceeding ” means (a) any case, action or proceeding before any court or other Governmental Authority relating to bankruptcy, reorganization, insolvency, liquidation, receivership, dissolution, winding-up or relief of debtors, including any proceeding under applicable Canadian federal or provincial corporate law seeking an arrangement or compromise of some or all of the debts of a Person or a stay of proceedings to enforce some or all claims of creditors against a Person, or (b) any general assignment for the benefit of creditors, composition, marshaling of assets for creditors, or other, similar arrangement in respect of any Person’s creditors generally or any substantial portion of such Person’s creditors, in each case undertaken under Canadian federal law, Canadian provincial or territorial law, United States federal law, U.S. state law, or foreign law, including the Bankruptcy Code and the Canadian Insolvency Legislation.

 

  12  

 

 

Intellectual Property ” means all Patents, Trademarks, Copyrights, and Technical Information, whether registered or not, domestic and foreign. Intellectual Property shall include all:

 

(a)          applications or registrations relating to such Intellectual Property;

 

(b)          rights and privileges arising under applicable Laws with respect to such Intellectual Property;

 

(c)          rights to sue for past, present or future infringements of such Intellectual Property; and

 

(d)          rights of the same or similar effect or nature in any jurisdiction corresponding to such Intellectual Property throughout the world.

 

Interest-Only Period ” means the period from and including the first Borrowing Date and through and including the sixteenth (16 th ) Payment Date following the first Borrowing Date unless the “Interest-Only Period” has been extended in accordance with Section 3.02(e) .

 

Interest Period ” means, with respect to each Borrowing, (a) initially, the period commencing on and including the Borrowing Date thereof and ending on and excluding the next Payment Date, and, (b) thereafter, each period beginning on and including the last day of the immediately preceding Interest Period and ending on and excluding the next succeeding Payment Date.

 

Invention ” means any novel, inventive and useful art, apparatus, method, process, machine (including article or device), manufacture or composition of matter, or any novel, inventive and useful improvement in any art, method, process, machine (including article or device), manufacture or composition of matter.

 

Investment ” means, for any Person: (a) the acquisition (whether for cash, property, services or securities or otherwise) of capital stock, bonds, notes, debentures, partnership or other ownership interests or other securities of any other Person or any agreement to make any such acquisition (including any “short sale” or any sale of any securities at a time when such securities are not owned by the Person entering into such sale); (b) the making of any deposit with, or advance, loan or other extension of credit to, any other Person (including the purchase of property from another Person subject to an understanding or agreement, contingent or otherwise, to resell such property to such Person), but excluding any such advance, loan or extension of credit having a term not exceeding 90 days arising in connection with the sale of inventory or supplies by such Person in the ordinary course of business; (c) the entering into of any Guarantee of, or other contingent obligation with respect to, Indebtedness or other liability of any other Person and (without duplication) any amount committed to be advanced, lent or extended to such Person; or (d) the entering into of any Hedging Agreement.

 

  13  

 

 

IRS ” means the U.S. Internal Revenue Service or any successor agency, and to the extent relevant, the U.S. Department of the Treasury.

 

Italian Account ” means an account, with a balance not to exceed $2,000,000 at any time, that is used as collateral against which Credit Suisse issues bid and performance bonds to Italian government regions for tenders of the Products.

 

Italian Civil Code ” means the Italian civil code, enacted by Royal Decree No. 262 of 16 March 1942, as subsequently amended and supplemented.

 

Knowledge ” means, with respect to any Person, the actual knowledge of any Responsible Officer of such Person and, in the case of Borrower, so long as he or she is employed by Borrower or its Subsidiaries, the actual knowledge of the chief executive officer or the chief financial officer, so long as such Person is an officer of Borrower.

 

Landlord Consent ” means a Landlord Consent substantially in the form of Exhibit F .

 

Laws ” means, collectively, all international, foreign, federal, state, provincial, territorial, municipal and local statutes, treaties, rules, guidelines, regulations, ordinances, codes and administrative or judicial precedents or authorities, including the interpretation or administration thereof by any Governmental Authority charged with the enforcement, interpretation or administration thereof, and all applicable administrative orders, directed duties, requests, licenses, authorizations and permits of, and agreements with, any Governmental Authority, in each case whether or not having the force of law.

 

Lender ” means each Person listed as a “Lender” on a signature page hereto, together with its successors, and each assignee of a Lender pursuant to Section 13.05(b) .

 

Lien ” means any mortgage, lien, hypothec, pledge, charge, assignment or other security interest, or any lease, title retention agreement, mortgage, restriction, easement, right-of-way, option or adverse claim (of ownership or possession) or other encumbrance of any kind or character whatsoever or any preferential arrangement that has the practical effect of creating a security interest.

 

Liquidity ” means the balance of unencumbered (other than by Liens securing the Obligations) cash and Permitted Cash Equivalent Investments (which for greater certainty shall not include any undrawn credit lines), in each case, to the extent held in an account over which the Secured Parties have a first priority perfected security interest and have received an executed deposit account control agreement, blocked account agreement or similar agreement, in form and substance satisfactory to the Administrative Agent, with respect to each such account.

 

Loan ” means (a) each loan advanced by a Lender pursuant to Section 2.01 and (b) each PIK Loan deemed to have been advanced by a Lender pursuant to Section 3.02(d). For purposes of clarification, any calculation of the aggregate outstanding principal amount of Loans on any date of determination shall include both the aggregate principal amount of loans advanced pursuant to Section 2.01 and not yet repaid, and all PIK Loans deemed to have been advanced and not yet repaid, on or prior to such date of determination.

 

  14  

 

 

Loan Documents ” means, collectively, this Agreement, the Fee Letter, the Assignment Agreement, the Security Documents, each Warrant, the English Guarantee, the German Security Trust Agreement, the Swiss Share Pledge Transfer Agreement, any other subordination agreement or any intercreditor agreement entered into by Administrative Agent (on behalf of the Lenders) with any other creditors of Obligors or any agent acting on behalf of such creditors, and any other present or future document, instrument, agreement or certificate executed by Obligors and delivered to Administrative Agent or any Secured Party in connection with or pursuant to this Agreement or any of the other Loan Documents, all as amended, restated, supplemented or otherwise modified.

 

Loss ” means judgments, debts, liabilities, expenses, costs, damages or losses, contingent or otherwise, whether liquidated or unliquidated, matured or unmatured, disputed or undisputed, contractual, legal or equitable, including loss of value, professional fees, including fees and disbursements of legal counsel on a full indemnity basis, and all costs incurred in investigating or pursuing any Claim or any proceeding relating to any Claim.

 

Majority Lenders ” means, at any time, Lenders having at such time in excess of 50% of the aggregate Commitments (or, if such Commitments are terminated, the outstanding principal amount of the Loans) then in effect, ignoring, in such calculation, the Commitments of and outstanding Loans owing to any Defaulting Lender.

 

Margin Stock ” means “margin stock” within the meaning of Regulation U.

 

Market Capitalization ” means, as of the date of determination, the product of (a) the sum of (i) the number of shares of Borrower’s common shares outstanding as of such date of determination and (ii) the number of shares (not included in clause (i)) of Borrower’s common shares that would be outstanding if all outstanding in-the-money stock options, warrants and convertible securities were exercised for, or converted into, as applicable, common shares and (b) the closing price of Borrower’s common shares on the Toronto Stock Exchange on such date of determination.

 

Material Adverse Change ” and “ Material Adverse Effect ” mean a material adverse change in or effect on (a) the business, condition (financial or otherwise), operations, performance, Property or prospects of Borrower and the other Obligors taken as a whole, (b) the ability of any Obligor to perform its obligations under the Loan Documents, or (c) the legality, validity, binding effect or enforceability of the Loan Documents or the rights and remedies of Administrative Agent or any Lender under any of the Loan Documents.

 

Material Agreements ” means (a) the agreements which are listed in Schedule 7.14 (as updated by Borrower from time to time in accordance with Section 8.16 to list all such agreements that meet the description set forth in clause (b) of this definition) and (b) all other agreements held by the Obligors from time to time, the absence or termination of any of which would reasonably be expected to result in a Material Adverse Effect; provided, however, that “Material Agreements” exclude all: (i) licenses implied by the sale of a product; and (ii) paid-up licenses for commonly available software programs under which an Obligor is the licensee. “Material Agreement” means any one such agreement.

 

  15  

 

 

Material Indebtedness ” means, at any time, any Indebtedness of any Obligor, the outstanding principal amount of which, individually or in the aggregate, exceeds $500,000 (or the Equivalent Amount in other currencies).

 

Material Intellectual Property ” means, the Obligor Intellectual Property described in Schedule 7.05(c) and any other Obligor Intellectual Property after the date hereof the loss of which could reasonably be expected to have a Material Adverse Effect.

 

Maturity Date ” means the earlier to occur of (a) the Stated Maturity Date, and (b) the date on which the Loans are accelerated pursuant to Section 11.02 .

 

Maximum Rate ” has the meaning set forth in Section 13.18(a).

 

MidCap ” means MidCap Financial Trust.

 

Minimum Required Revenue ” has the meaning set forth in Section in 10.02.

 

Multiemployer Plan ” means any multiemployer plan, as defined in Section 400l(a)(3) of ERISA, to which any ERISA Affiliate incurs or otherwise has any obligation or liability, contingent or otherwise.

 

Murk Stock and Asset Purchase Agreement ” means the stock and asset purchase agreement dated as of November 18, 2013 between the Original Borrower (and subsequently assigned to the Borrower), Cardiome International SA, Murk Acquisition Sub, Inc., Correvio LLC and CarCor Investment Holdings LLC.

 

Non-Consenting Lender ” has the meaning set forth in Section 2.06(a) .

 

Non-Disclosure Agreement ” has the meaning set forth in Section 13.16 .

 

Non-Qualifying Bank Creditor Rules ” means the 10-Non-Qualifying Bank Creditor Rule and the 20-Non-Qualifying Bank Creditor Rule.

 

Notice of Borrowing ” has the meaning set forth in Section 2.02 .

 

Obligations ” means, with respect to any Obligor, all amounts, obligations, liabilities, covenants and duties of every type and description owing by such Obligor to any Lender, any other indemnitee hereunder or any participant, arising out of, under, or in connection with, any Loan Document, whether direct or indirect (regardless of whether acquired by assignment), absolute or contingent, due or to become due, whether liquidated or not, now existing or hereafter arising and however acquired, and whether or not evidenced by any instrument or for the payment of money, including, without duplication, (a) if such Obligor is Borrower, all Loans, (b) all interest, whether or not accruing after the filing of any petition in bankruptcy or after the commencement of any insolvency, reorganization or similar proceeding, and whether or not a claim for post-filing or post-petition interest is allowed in any such proceeding, and (c) all other fees, expenses (including fees, charges and disbursement of counsel), interest, commissions, charges, costs, disbursements, indemnities and reimbursement of amounts paid and other sums chargeable to such Obligor under any Loan Document.

 

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Obligor Intellectual Property ” means Intellectual Property owned by or licensed to any of the Obligors other than immaterial Intellectual Property owned by any Obligor in a jurisdiction which such Obligor does not have assets or revenue with a fair market value greater than $1,000,000 in aggregate.

 

Obligors ” means, collectively, Borrower and the Subsidiary Guarantors and their respective successors and permitted assigns.

 

Original Agreement ” has the meaning set forth in the introduction hereto.

 

Original Borrower ” has the meaning set forth in the introduction hereto.

 

Original Closing Date ” means June 13, 2016.

 

Other Connection Taxes ” means, with respect to any Recipient, Taxes imposed as a result of a present or former connection between such Recipient and the jurisdiction imposing such Tax (other than connections arising from such Recipient having executed, delivered, become a party to, performed its obligations under, received payments under, received or perfected a security interest under, engaged in any other transaction pursuant to or enforced any Loan Document, or sold or assigned an interest in any Loan or Loan Document).

 

Other Taxes ” means all present or future stamp, court or documentary, intangible, recording, filing or similar Taxes that arise from any payment made under, from the execution, delivery, performance, enforcement or registration of, from the receipt or perfection of a security interest under, or otherwise with respect to, any Loan Document, except any such Taxes that are Other Connection Taxes imposed with respect to an assignment (other than an assignment made pursuant to Section 5.03(g) ).

 

Participant ” has the meaning set forth in Section 13.05(e) .

 

Patents ” has the meaning set forth in the Canadian Security Agreement.

 

Payment Date ” means each March 31, June 30, September 30, December 31 and the Maturity Date, commencing on the first such date to occur following the first Borrowing Date; provided that , if any such date shall occur on a day that is not a Business Day, the applicable Payment Date shall be the immediately preceding Business Day.

 

PBGC ” means the United States Pension Benefit Guaranty Corporation referred to and defined in ERISA and any successor entity performing similar functions.

 

Permitted Acquisition ” means any acquisition by Borrower or any of its wholly-owned Subsidiaries, whether by purchase, merger, amalgamation or otherwise, of all or substantially all of the assets of, all of the Equity Interests of, or a business line or unit or a division of, any Person; provided that :

 

(a)          immediately prior to, and after giving effect thereto, no Default or Event of Default shall have occurred and be continuing or would result therefrom;

 

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(b)          all transactions in connection therewith shall be consummated, in all material respects, in accordance with all applicable Laws and in conformity with all applicable Governmental Approvals;

 

(c)          in the case of the acquisition of all of the Equity Interests of such Person, all of the Equity Interests acquired, or otherwise issued by such Person or any newly formed Subsidiary of Borrower in connection with such acquisition, shall be owned 100% by an Obligor or any other Subsidiary, and Borrower shall have taken, or caused to be taken, as of the date such Person becomes a Subsidiary of Borrower, each of the actions set forth in Section 8.12 , if applicable;

 

(d)          Borrower and its Subsidiaries shall be in compliance with the financial covenants set forth in Section 10.01 and Section 10.02 on a pro forma basis after giving effect to such acquisition;

 

(e)          such Person (in the case of an acquisition of Equity Interests) or assets (in the case of an acquisition of assets or a division) (i) shall be engaged or used, as the case may be, in the same business or lines of business in which Borrower and/or its Subsidiaries are engaged or (ii) shall have a similar customer base as Borrower and/or its Subsidiaries; and

 

(f)           such Person has not at any time in the past or present established or been associated with any Canadian Pension Plans or any Canadian Benefit Plans.

 

Permitted Cash Equivalent Investments ” means investments made in accordance with the Borrower’s investment policy in existence as of the date of this Agreement provided that all such investments remain liquid at all times.

 

Permitted Credit Card Indebtedness ” means all Indebtedness owing by the Obligors in respect of Visa, Mastercard or other credit or charge card.

 

Permitted Cure Debt ” means Indebtedness incurred in connection with the exercise of the Subordinated Debt Cure Right and (a) that is governed by documentation containing representations, warranties, covenants and events of default no more burdensome or restrictive than those contained in the Loan Documents, (b) that has a maturity date at least six (6) months later than the Maturity Date, (c) in respect of which no cash payments of principal or interest are required prior to the Maturity Date, and (d) in respect of which the holders have agreed in favor of Borrower, Administrative Agent and Lenders (i) that prior to the date on which the Commitments have expired or been terminated and all Obligations have been paid in full indefeasibly in cash, such holders will not exercise any remedies available to them in respect of such Indebtedness, (ii) that such Indebtedness is unsecured, and (iii) to terms of subordination in an agreement in form and substance satisfactory to the Majority Lenders.

 

Permitted Indebtedness ” means any Indebtedness permitted under Section 9.01 .

 

Permitted Liens ” means any Liens permitted under Section 9.02 .

 

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Permitted Priority Liens ” means (a) Liens permitted under Section 9.02(c), (d), (f), (g), (h), (i), (l), (m) and (o) , and (b) Liens permitted under Section 9.02(b) provided that such Liens are also of the type described in Section 9.02(c), (d), (f), (g), (h), (i), (l), (m) and (o).

 

Permitted Refinancing ” means, with respect to any Indebtedness, any extensions, renewals and replacements of such Indebtedness; provided that such extension, renewal or replacement (a) shall not increase the outstanding principal amount of such Indebtedness, (b) contains terms relating to outstanding principal amount, amortization, maturity, collateral (if any) and subordination (if any), and other material terms taken as a whole no less favorable in any material respect to Borrower and its Subsidiaries or the Secured Parties than the terms of any agreement or instrument governing such existing Indebtedness, (c) shall have an applicable interest rate which does not exceed the rate of interest of the Indebtedness being replaced, and (d) shall not contain any new requirement to grant any lien or security or to give any guarantee that was not an existing requirement of such Indebtedness.

 

Person ” means any individual, corporation, company, voluntary association, partnership, limited liability company, unlimited liability company, joint venture, trust, unincorporated organization or Governmental Authority or other entity of whatever nature.

 

PIK Loan ” has the meaning set forth in Section 3.02(d) .

 

PIK Period ” means the period beginning on the First Restatement Date through and including the earlier to occur of (a) March 31, 2020, and (b) the date on which any Default shall have occurred ( provided that if such Default shall have been cured or waived, the PIK Period shall resume until the earlier to occur of the next Default and March 31, 2020); provided, however, that upon the Borrower achieving the Revenue Milestone the PIK Period shall be extended to the Maturity Date.

 

Plan ” means any employee pension benefit plan (other than a Multiemployer Plan) subject to the provisions of Title IV of ERISA or Section 412 of the Code or Section 302 of ERISA, and in respect of which Borrower or any ERISA Affiliate is (or, if such plan were terminated, would under Section 4069 of ERISA be deemed to be) an “employer” as defined in Section 3(5) of ERISA.

 

PPSA ” shall mean the Personal Property Security Act (Ontario), the Civil Code of Québec or any other applicable Canadian federal, provincial or territorial statute pertaining to the granting, perfecting, priority or ranking of security interests, liens, hypothecs on personal property, and any successor statues, together with any regulations thereunder or Ministerial orders in respect thereof, in each case as in effect from time to time. References to sections of the PPSA and the Civil Code of Québec shall be construed to also refer to any successor sections.

 

Prepayment Premium ” has the meaning set forth in Section 3.03(a) .

 

Product ” means Aggrastat, Brinavess, Esmolol, Trevyent, Dalbavancin, Impavido and other products to be acquired or in-licensed, and each of their respective successors.

 

Property ” of any Person means any property or assets, or interest therein, of such Person.

 

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Proportionate Share ” means, with respect to any Lender, the percentage obtained by dividing (a) the sum of the Commitment (or, if the Commitments are terminated, the outstanding principal amount of the Loans) of such Lender then in effect by (b) the sum of the Commitments (or, if the Commitments are terminated, the outstanding principal amount of the Loans) of all Lenders then in effect.

 

Qualified Plan ” means an employee benefit plan (as defined in Section 3(3) of ERISA) other than a Multiemployer Plan (a) that is or was at any time maintained or sponsored by any Obligor or any ERISA Affiliate thereof or to which any Obligor or any ERISA Affiliate thereof has ever made, or was ever obligated to make, contributions, and (b) that is intended to be tax qualified under Section 401(a) of the Code.

 

Qualifying Bank Creditor ” means any entity which effectively conducts true banking activities as its principal purpose with its own infrastructure and staff, premises, communication devices of its own and the authority of decision making, and which is recognised as a bank by the banking laws in force in the jurisdiction of its incorporation.

 

Recipient ” means Administrative Agent, any Lender or any other recipient of any payment to be made by or on account of any Obligation.

 

Redemption Date ” has the meaning set forth in Section 3.03(a) .

 

Redemption Price ” has the meaning set forth in Section 3.03(a) .

 

Register ” has the meaning set forth in Section 13.05(d) .

 

Regulation T ” means Regulation T of the Board of Governors of the Federal Reserve System, as amended.

 

Regulation U ” means Regulation U of the Board of Governors of the Federal Reserve System, as amended.

 

Regulation X ” means Regulation X of the Board of Governors of the Federal Reserve System, as amended.

 

Regulatory Approvals ” means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

 

Related Person ” means, with respect to any Person, such Person’s Affiliates and the partners, directors, officers, employees, agents, trustees, administrators, managers, advisors and representatives of such Person and of such Person’s Affiliates.

 

Requirement of Law ” means, as to any Person, any statute, law, treaty, rule or regulation or determination, order, injunction or judgment of an arbitrator or a court or other Governmental Authority, in each case applicable to or binding upon such Person or any of its Properties or revenues.

 

Responsible Officer ” of any Person means each of the president, chief executive officer, and chief financial officer of such Person.

 

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Restricted Payment ” means any dividend or other distribution (whether in cash, securities or other property) with respect to any Equity Interest of Borrower or any of its Subsidiaries, or any payment (whether in cash, securities or other property), including any sinking fund or similar deposit, on account of the purchase, redemption, retirement, acquisition, cancellation or termination of any such shares of capital stock of Borrower or any of its Subsidiaries or any option, warrant or other right to acquire any such shares of capital stock of Borrower or any of its Subsidiaries.

 

Restrictive Agreement ” has the meaning set forth in Section 7.15 .

 

Revenue ” of a Person means all revenue properly recognized under GAAP, consistently applied, less all rebates, discounts and other price allowances.

 

Revenue Milestone ” has the meaning set forth in Section 3.2(d) .

 

Secured Parties ” means the Lenders, Administrative Agent, each other Indemnified Party and any other holder of any Obligation.

 

Security Documents ” means, collectively, the Canadian Security Documents, the U.S. Security Documents, the English Security Documents, the French Security Documents, the German Security Documents, the Swiss Security Documents and each other security document, control agreement or other agreement that creates or purports to create Liens in favor of the Secured Parties, as such agreements may be amended, restated, replaced, supplemented or otherwise modified from time to time.

 

Securities Account ” has the meaning set forth in the Canadian Security Agreement.

 

Series A Shares ” has the meaning given to such term in the Borrower’s articles of amalgamation.

 

Short-Form IP Security Agreements ” means the Canadian Short-Form IP Security Agreements and the U.S. Short-Form IP Security Agreements.

 

Solvent ” means, with respect to any Person at any time, that (a) the fair saleable value of the Property of such Person is greater than the total amount of liabilities (including contingent liabilities) of such Person, (b) the present fair saleable value of the Property of such Person is not less than the amount that will be required to pay the probable liability of such Person on its debts as they become absolute and matured, (c) such Person has not incurred and does not intend to, and does not believe that it will, incur debts or liabilities beyond such Person’s ability to pay as such debts and liabilities mature, and (d) such Person is not an “insolvent person” within the meaning of the Bankruptcy and Insolvency Act (Canada).

 

Specified Financial Covenants ” has the meaning set forth in Section 10.03(a) .

 

Stated Maturity Date ” means the twenty-fourth (24 th ) Payment Date following the first Borrowing Date.

 

Subordinated Debt Cure Right ” has the meaning set forth in Section 10.03(a) .

 

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Subsidiary ” means, with respect to any Person (the “ parent ”) at any date, any corporation, limited liability company, unlimited liability company, partnership, association or other entity the accounts of which would be consolidated with those of the parent in the parent’s consolidated financial statements if such financial statements were prepared in accordance with GAAP as of such date, as well as any other corporation, limited liability company, unlimited liability company, partnership, association or other entity (a) of which securities or other ownership interests representing more than 50% of the equity or more than 50% of the ordinary voting power or, in the case of a partnership, more than 50% of the general partnership interests are, as of such date, owned, controlled or held, or (b) that is, as of such date, otherwise Controlled, by the parent or one or more subsidiaries of the parent or by the parent and one or more subsidiaries of the parent.

 

Subsidiary Guarantors ” means each of the Subsidiaries of Borrower identified under the caption “SUBSIDIARY GUARANTORS” on the signature pages hereto and each Subsidiary of Borrower that becomes a “Subsidiary Guarantor” after the date hereof pursuant to Section 8.12(a) or (b) after having satisfied the requirements of such Sections, as applicable.

 

Substitute Lender ” has the meaning set forth in Section 2.06(a) .

 

Swiss Federal Tax Administration ” means the Swiss Federal tax administration (Eidgenössische Steuerverwaltung).

 

Swiss Guarantor ” means any of Cardiome International SA, Correvio International Sàrl and each other Subsidiary Guarantor party hereto, from time to time, organized under the laws of Switzerland.

 

Swiss Share Pledge Transfer Agreement ” has the meaning set forth in Section 6.06(iv)(D).

 

Swiss Security Documents ” means collectively, (a) security agreements executed by each of the Swiss Guarantors in favor of the Administrative Agent on behalf of the Secured Parties creating a first ranking security interest over certain of the Swiss Guarantor’s present and future (i) bank account claims, (ii) intellectual property rights and royalty claims, and (iii) trade, intra-group and insurance receivables; (b) share/quota pledge agreements executed by all of the shareholders or each of the Swiss Guarantors in favor of the Administrative Agent on behalf of the Secured Parties creating a first ranking security interest over all of the shares/quota in the capital of each of the Swiss Guarantors; and (c) any other agreement that creates or purports to create security and that is entered into by a Swiss Guarantor, all governed by the laws of Switzerland (as any such agreement may be amended, restated, replaced, supplemented or otherwise modified from time to time).

 

Swiss Witholding Tax ” means any withholding tax imposed under the Swiss Withholding Tax Act.

 

Swiss Withholding Tax Act ” means the Swiss Federal Act on Anticipatory Tax of October 13, 1965 (Bundesgesetz über die Verrechnungssteuer) with related regulations and guidelines, all as amended and applicable from time to time.

 

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Taxes ” means all present or future taxes, levies, imposts, duties, deductions, withholdings (including backup withholding), assessments, fees or other charges imposed by any Governmental Authority, including any interest, additions to tax or penalties applicable thereto.

 

Technical Information ” means all trade secrets and other proprietary or confidential information, public information, non-proprietary know-how, any information of a scientific, technical, or business nature in any form or medium, standards and specifications, conceptions, ideas, innovations, discoveries, Invention disclosures, all documented research, developmental, demonstration or engineering work and all other information, data, plans, specifications, reports, summaries, experimental data, manuals, models, samples, know-how, technical information, systems, methodologies, computer programs, information technology and any other information.

 

Third Borrowing Milestone ” has the meaning set forth in Section 6.03(c) .

 

Title IV Plan ” means an employee benefit plan (as defined in Section 3(3) of ERISA) other than a Multiemployer Plan (i) that is or was within the past six (6) years maintained or sponsored by any Obligor or any ERISA Affiliate thereof or to which any Obligor or any ERISA Affiliate thereof is or was obligated to make within the past six (6) years, contributions, and (ii) that is or was subject to Section 412 of the Code, Section 302 of ERISA or Title IV of ERISA.

 

Trademarks ” is defined in the Canadian Security Agreement.

 

Transactions ” means the execution, delivery and performance by each Obligor of this Agreement and the other Loan Documents to which such Obligor is intended to be a party and the Borrowings (and the use of the proceeds of the Loans).

 

U.S. Person ” means a “United States Person” within the meaning of Section 7701(a)(30) of the Code.

 

U.S. Security Agreement ” means the Amended and Restated U.S. Security Agreement, dated as of the Closing Date, among Cardiome, Inc., Artesian Therapeutics, Inc., Murk Acquisition Sub, Inc., Correvio LLC, the Borrower and Administrative Agent, granting a security interest in each of such Obligor’s personal Property in favor of the Secured Parties (as such agreement may be amended, restated, replaced, supplemented or otherwise modified from time to time).

 

U.S. Security Documents ” means the U.S. Security Agreement, each U.S. Short-Form IP Security Agreement and any other agreement governed by U.S. law that creates or purports to create security and that is entered into by a U.S. Obligor pursuant to this Agreement.

 

U.S. Short-Form IP Security Agreement ” means the amended and restated (if applicable) short-form copyright, patent or trademark (as the case may be) security agreements governed by the laws of any state or political subdivision of the United States of America, dated as of the Original Closing Date or the Closing Date, as the case may be, entered into by one or more Obligors in favor of the Secured Parties, each in form and substance satisfactory to the Majority Lenders (as such agreement may be amended, restated, replaced, supplemented or otherwise modified from time to time)).

 

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U.S. Tax Compliance Certificate ” has the meaning set forth in Section 5.03(e)(ii)(B)(3) .

 

Warrants ” means the warrants to purchase Equity Interests of Borrower, issued by Borrower to the Lender as to replace the warrants previously issued by the Original Borrower as an inducement for the Lenders to agree to the amendments to the Original Agreement and to the First Amendment.

 

Withdrawal Liability ” means, at any time, any liability incurred (whether or not assessed) by any ERISA Affiliate and not yet satisfied or paid in full at such time with respect to any Multiemployer Plan pursuant to Section 4201 of ERISA.

 

1.02       Accounting Terms and Principles. All accounting determinations required to be made pursuant hereto shall, unless expressly otherwise provided herein, be made in accordance with GAAP. All components of financial calculations made to determine compliance with this Agreement, including Section 10 , shall be adjusted to include or exclude, as the case may be, without duplication, such components of such calculations attributable to any Acquisition consummated after the first day of the applicable period of determination and prior to the end of such period, as determined in good faith by Borrower based on assumptions expressed therein and that were reasonable based on the information available to Borrower at the time of preparation of the Compliance Certificate setting forth such calculations.

 

1.03       Interpretation. For all purposes of this Agreement, except as otherwise expressly provided herein or unless the context otherwise requires, (a) the terms defined in this Agreement include the plural as well as the singular and vice versa; (b) words importing gender include all genders; (c) any reference to a Section, Annex, Schedule or Exhibit refers to a Section of, or Annex, Schedule or Exhibit to, this Agreement; (d) any reference to “this Agreement” refers to this Agreement, including all Annexes, Schedules and Exhibits hereto, and the words herein, hereof, hereto and hereunder and words of similar import refer to this Agreement and its Annexes, Schedules and Exhibits as a whole and not to any particular Section, Annex, Schedule, Exhibit or any other subdivision; (e) references to days, months and years refer to calendar days, months and years, respectively; (f) all references herein to “include” or “including” shall be deemed to be followed by the words “without limitation”; (g) the word “from” when used in connection with a period of time means “from and including” and the word “until” means “to but not including”; and (h) accounting terms not specifically defined herein shall be construed in accordance with GAAP (except for the term “property” , which shall be interpreted as broadly as possible, including, in any case, cash, securities, other assets, rights under contractual obligations and permits and any right or interest in any property, except where otherwise noted). Unless otherwise expressly provided herein, references to organizational documents, agreements (including the Loan Documents) and other contractual instruments shall be deemed to include all permitted subsequent amendments, restatements, extensions, supplements and other modifications thereto.

 

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1.04       Quebec Interpretation Clause. For purposes of any assets, liabilities or entities located in the Province of Québec and for all other purposes pursuant to which the interpretation or construction of this Agreement may be subject to the laws of the Province of Québec or a court or tribunal exercising jurisdiction in the Province of Québec, (i) “personal property” shall be deemed to include “movable property”, (ii) “real property” shall be deemed to include “immovable property”, (iii) “tangible property” shall be deemed to include “corporeal property”, (iv) “intangible property” shall be deemed to include “incorporeal property”, (v) “security interest”, “mortgage” and “lien” shall be deemed to include a “hypothec”, “prior claim”, “reservation of ownership” and a “resolutory clause”, (vi) all references to filing, registering or recording under the Uniform Commercial Code or the Personal Property Security Act shall be deemed to include publication under the Civil Code of Québec, (vii) all references to “perfection” of or “perfected” liens or security interest shall be deemed to include a reference to an “opposable” or “set up” hypothec as against third parties, (viii) any “right of offset”, “right of setoff” or similar expression shall be deemed to include a “right of compensation”, (ix) “goods” shall be deemed to include “corporeal movable property” other than chattel paper, documents of title, instruments, money and securities, (x) an “agent” shall be deemed to include a “mandatary”, (xi) “construction liens” shall be deemed to include “legal hypothecs in favour of persons having taken part in the construction or renovation of an immovable”; (xii) “joint and several” shall be deemed to include “solidary”; (xiii) “gross negligence or willful misconduct” shall be deemed to be “intentional or gross fault”; (xiv) “beneficial ownership” shall be deemed to include “ownership”; (xv) “legal title” shall be deemed to include “holding title on behalf of an owner as mandatary or prête-nom”; (xvi) “easement” shall be deemed to include “servitude”; (xvii) “priority” shall be deemed to include “rank” or “prior claim”, as applicable; (xviii) “survey” shall be deemed to include “certificate of location and plan”; (xix) “state” shall be deemed to include “province”; (xx) “fee simple title” shall be deemed to include “ownership” (including ownership under a right of superficies); (xi) “ground lease” shall be deemed to include “emphyteusis” or a “lease with a right of superficies”, as applicable; (xii) “leasehold interest” shall be deemed to include “a valid lease”; (xiii) “lease” shall be deemed to include a “contract of leasing (crédit-bail)” and (xiv) “deposit account” shall include a “financial account” as defined in Article 2713.6 of the Civil Code of Québec.

 

1.05       Changes to GAAP. If, after the date hereof, any change occurs in GAAP or in the application thereof and such change would cause any amount required to be determined for the purposes of the covenants to be maintained or calculated pursuant to Section 8 , 9 or 10 to be materially different than the amount that would be determined prior to such change, then:

 

(a)          Borrower will provide a detailed notice of such change (an “ Accounting Change Notice ”) to Administrative Agent within 30 days of such change;

 

(b)          either Borrower or the Majority Lenders may indicate within 90 days following the date of the Accounting Change Notice that they wish to revise the method of calculating such financial covenants or amend any such amount, in which case the parties will in good faith attempt to agree upon a revised method for calculating the financial covenants;

 

(c)          until Borrower and the Majority Lenders have reached agreement on such revisions, (i) such financial covenants or amounts will be determined without giving effect to such change and (ii) all financial statements, Compliance Certificates and similar documents provided hereunder shall be provided together with a reconciliation between the calculations and amounts set forth therein before and after giving effect to such change in GAAP;

 

(d)          if no party elects to revise the method of calculating the financial covenants or amounts, then the financial covenants or amounts will not be revised and will be determined in accordance with GAAP without giving effect to such change; and

 

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(e) any Event of Default arising as a result of such change which is cured by operation of this Section 1.04 shall be deemed to be of no effect ab initio .

 

SECTION 2

THE COMMITMENT

 

2.01       Commitments. Each Lender agrees severally, on and subject to the terms and conditions of this Agreement (including Section 6 ), to make up to four term loans (provided that PIK Loans shall be deemed not to constitute “term loans” for purposes of this Section 2.01 ) to Borrower, each on a Business Day during the Commitment Period in Dollars in an aggregate principal amount for such Lender not to exceed such Lender’s Commitment; provided , however , that at no time shall any Lender be obligated to make a Loan in excess of such Lender’s Proportionate Share of the amount by which the then effective Commitments exceeds the aggregate principal amount of Loans outstanding at such time. Amounts of Loans repaid may not be reborrowed.

 

2.02       Borrowing Procedures. Subject to the terms and conditions of this Agreement (including Section 6 ), each Borrowing (other than a Borrowing of PIK Loans) shall be made on written notice in the form of Exhibit B given by Borrower to Administrative Agent not later than 11:00 a.m. (Central time) on the Borrowing Notice Date (a “ Notice of Borrowing ”).

 

2.03       Fees. Borrower shall pay to Administrative Agent and/or the Lenders, as applicable, such fees as described in the Fee Letter.

 

2.04       Use of Proceeds.

 

(a)          Borrower shall use the proceeds of the Loans for general working capital purposes and corporate purposes, to pay fees, costs and expenses incurred in connection with the Transactions and, only with respect to the first Borrowing, to pay existing Indebtedness owing to MidCap as set out in Section 6.01(g)(xiv) , but in no event shall the proceeds of the Loans be deposited or held in any account in which the Secured Parties do not have a first priority perfected security interest and in which the Administrative Agent has not received an executed deposit account control agreement, blocked account agreement or similar agreement, in form and substance satisfactory to the Administrative Agent; provided that the Lenders shall have no responsibility as to the use of any proceeds of Loans.

 

(b)          Notwithstanding the generality of Section 2.04(a) above:

 

(i)           the Borrower shall be permitted to receive the proceeds of the Loans in an account domiciled in Canada opened on behalf of and for the sole benefit of the Borrower despite such account not being subject to an executed deposit account control agreement, blocked account agreement or similar agreement as of the date of this Agreement; provided that the Borrower shall provide the Administrative Agent an executed deposit account control agreement, blocked account agreement or similar agreement, in form and substance satisfactory to the Administrative Agent, in accordance with the terms of Schedule 8.17 ; and

 

(ii)          the Borrower shall be permitted to provide proceeds of the Loans to deposit accounts held by and for the sole benefit of a Subsidiary Guarantor despite such account not being subject to an executed deposit account control agreement, blocked account agreement or similar agreement provided that at no time shall the aggregate account balance of all such accounts exceed $1,000,000.

 

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(c)          No proceeds of the Loans shall be, directly or indirectly, extended, on-lent or otherwise advanced to any Swiss Guarantor (not including however a contribution of proceeds of the Loans into the equity of such Swiss Guarantor, which shall be permissible at all times) until such Swiss Guarantor has delivered to the Administrative Agent an officer’s certificate certifying that such Swiss Guarantor has obtained a confirmation (reasonably satisfactory as to content to the Administrative Agent) from the Swiss Federal Tax Administration (a copy of such confirmation to be attached to the officer’s certificate) which either (i) confirms that the entities that are a party to this Agreement as Lenders as of the date hereof are each eligible to qualify as one sole lender for the purpose of the 10-Non-Qualifying Bank Creditor Rule or (ii) otherwise confirms that no Swiss Withholding Tax will be imposed in respect of any payments of interest or in respect of any other payments related to the Loans.

 

2.05       Defaulting Lenders.

 

(a)           Adjustments . Notwithstanding anything to the contrary contained in this Agreement, if any Lender becomes a Defaulting Lender, then, until such time as that Lender is no longer a Defaulting Lender, to the extent permitted by applicable law:

 

(i)            Waivers and Amendments . Such Defaulting Lender’s right to approve or disapprove any amendment, waiver or consent with respect to this Agreement shall be restricted as set forth in Section 13.04 .

 

(ii)           Reallocation of Payments . Any payment of principal, interest, fees or other amounts received by the Lenders for the account of such Defaulting Lender (whether voluntary or mandatory, at maturity, pursuant to Section 11 or otherwise), shall be applied at such time or times as follows: first, as Borrower may request (so long as no Default exists), to the funding of any Loan in respect of which such Defaulting Lender has failed to fund its portion thereof as required by this Agreement; second, if so determined by the Majority Lenders and Borrower, to be held in a non-interest bearing deposit account and released in order to satisfy obligations of such Defaulting Lender to fund Loans under this Agreement; third, to the payment of any amounts owing to the Lenders as a result of any judgment of a court of competent jurisdiction obtained by any Lender against such Defaulting Lender as a result of such Defaulting Lender’s breach of its obligations under this Agreement; fourth, so long as no Default exists, to the payment of any amounts owing to Borrower as a result of any judgment of a court of competent jurisdiction obtained by Borrower against such Defaulting Lender as a result of such Defaulting Lender’s breach of its obligations under this Agreement; and fifth, to such Defaulting Lender or as otherwise directed by a court of competent jurisdiction; provided that if (A) such payment is a payment of the principal amount of any Loans in respect of which such Defaulting Lender has not fully funded its appropriate share and (B) such Loans were made at a time when the conditions set forth in Section 6 were satisfied or waived, such payment shall be applied solely to pay the Loans of all non-Defaulting Lenders on a pro rata basis prior to being applied to the payment of any Loans of such Defaulting Lender. Any payments, prepayments or other amounts paid or payable to a Defaulting Lender that are applied (or held) to pay amounts owed by a Defaulting Lender pursuant to this Section 2.05(a)(ii) shall be deemed paid to and redirected by such Defaulting Lender, and each Lender irrevocably consents hereto.

 

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(b)           Defaulting Lender Cure . If Borrower and the Majority Lenders agree in writing in their sole discretion that a Defaulting Lender should no longer be deemed to be a Defaulting Lender, that Lender will, to the extent applicable, purchase that portion of outstanding Loans of the other Lenders or take such other actions as necessary to cause the Loans to be held on a pro rata basis by the Lenders in accordance with their Proportionate Share, whereupon that Lender will cease to be a Defaulting Lender; provided that no adjustments will be made retroactively with respect to fees accrued or payments made by or on behalf of Borrower while that Lender was a Defaulting Lender; and provided, further, that except to the extent otherwise expressly agreed by the affected parties, no change hereunder from Defaulting Lender to Lender will constitute a waiver or release of any claim of any party hereunder arising from that Lender’s having been a Defaulting Lender.

 

2.06       Substitution of Lenders.

 

(a)           Substitution Right . If any Lender (an “ Affected Lender ”), (i) becomes a Defaulting Lender or (ii) does not consent to any amendment, waiver or consent to any Loan Document for which the consent of the Majority Lenders is obtained but that requires the consent of other Lenders (a “ Non-Consenting Lender ”), then (x) Borrower may elect to pay in full such Affected Lender with respect to all Obligations due to such Affected Lender or (y) either Borrower or Administrative Agent shall identify any willing Lender or Affiliate of any Lender or Eligible Transferee (in each case, a “ Substitute Lender ”) to substitute for such Affected Lender; provided that any substitution of a Non-Consenting Lender shall occur only with the consent of Administrative Agent.

 

(b)           Procedure . To substitute such Affected Lender or pay in full all Obligations owed to such Affected Lender, Borrower shall deliver a notice to such Affected Lender. The effectiveness of such payment or substitution shall be subject to the delivery by Borrower (or, as may be applicable in the case of a substitution, by the Substitute Lender) of (i) payment for the account of such Affected Lender, of, to the extent accrued through, and outstanding on, the effective date for such payment or substitution, all Obligations owing to such Affected Lender (which for the avoidance of doubt, shall not include any Prepayment Premium) and (ii) in the case of a substitution, an Assignment and Assumption executed by the Substitute Lender, which shall thereunder, among other things, agree to be bound by the terms of the Loan Documents.

 

(c)           Effectiveness . Upon satisfaction of the conditions set forth in Sections 2.06(a) and (b) , Administrative Agent shall record such substitution or payment in the Register, whereupon (i) in the case of any payment in full of an Affected Lender, such Affected Lender’s Commitments shall be terminated and (ii) in the case of any substitution of an Affected Lender, (A) such Affected Lender shall sell and be relieved of, and the Substitute Lender shall purchase and assume, all rights and claims of such Affected Lender under the Loan Documents, except that the Affected Lender shall retain such rights under the Loan Documents that expressly provide that they survive the repayment of the Obligations and the termination of the Commitments, (B) such Affected Lender shall no longer constitute a “Lender” hereunder and such Substitute Lender shall become a “Lender” hereunder and (C) such Affected Lender shall execute and deliver an Assignment and Assumption to evidence such substitution; provided , however , that the failure of any Affected Lender to execute any such Assignment and Assumption shall not render such sale and purchase (or the corresponding assignment) invalid.

 

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2.07       Prior Borrowings. The Borrower hereby acknowledges (x) that the Original Borrower made (i) the first Borrowing on June 14, 2016 in an amount of $20,000,000, (ii) the second Borrowing on May 11, 2017 in an amount of $10,000,000 and (iii) the third Borrowing on August 8, 2017 in an amount of $10,000,000, each of which remain outstanding as of the date hereof and (y) receipt of the proceeds of each such Borrowing pursuant to the terms of the Assignment Agreement.

 

SECTION 3

PAYMENTS OF PRINCIPAL AND INTEREST

 

3.01       Repayment.

 

(a)           Repayment . During the Interest-Only Period, no payments of principal of the Loans shall be due. Borrower agrees to repay to the Lenders the outstanding principal amount of the Loans, on each Payment Date occurring after the Interest-Only Period, in equal installments. The amounts of such installments shall be calculated by dividing (i) the sum of the aggregate principal amount of the Loans outstanding on the first day following the end of the Interest-Only Period, by (ii) the number of Payment Dates remaining prior to and including the Stated Maturity Date.

 

(b)           Application . Any optional or mandatory prepayment of the Loans shall be applied to the installments thereof under Section 3.01(a) in the inverse order of maturity. To the extent not previously paid, the principal amount of the Loans, together with all other outstanding Obligations, shall be due and payable on the Maturity Date.

 

3.02       Interest.

 

(a)           Interest Generally . Subject to Section 3.02(d) , Borrower agrees to pay to the Lenders interest on the unpaid principal amount of the Loans and the amount of all other outstanding Obligations, in the case of the Loans, for the period from the applicable Borrowing Date, and in the case of any other Obligation, from the date such other Obligation is due and payable, in each case, until paid in full, at a rate per annum equal to (i) on and after the First Restatement Date, thirteen percent (13%), and (ii) from the Original Closing Date to the date immediately preceding the First Restatement Date, fourteen percent (14%).

 

(b)           Default Interest . Notwithstanding the foregoing, upon the occurrence and during the continuance of any Event of Default, the interest payable pursuant to Section 3.02(a) shall, subject to applicable laws, increase automatically by 4.00% per annum (such aggregate increased rate, the “ Default Rate ”). Notwithstanding any other provision herein, interest required to be paid at the Default Rate shall be paid entirely in cash. If any Obligation is not paid when due under the applicable Loan Document, the amount thereof shall, subject to applicable laws, accrue interest at a rate equal to 4.00% per annum (without duplication of interest payable at the Default Rate). Each Obligor acknowledges that interest payable under this Agreement at the Default Rate represents a genuine pre-estimate of damages to the Lenders and shall not be construed as a penalty.

 

(c)           Interest Payment Dates . Subject to Section 3.02(d) , accrued interest on the Loans shall be payable in arrears on each Payment Date with respect to the most recently completed Interest Period in cash, and upon the payment or prepayment of the Loans (on the principal amount being so paid or prepaid); provided that interest payable at the Default Rate shall be payable from time to time on demand.

 

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(d)           Paid In-Kind Interest . Notwithstanding Section 3.01(a) , at any time during the PIK Period, Borrower may, on notice to the Administrative Agent, elect at the time that the Borrower makes the applicable interest payment to pay the interest on the outstanding principal amount of the Loans payable pursuant to Section 3.01 as follows: (i) only 9.00% of the 13.00% per annum interest in cash and (ii) 4.00% of the 13.00% per annum interest as compounded interest, which will be added to the aggregate principal amount of the Loans (the amount of any such compounded interest being a “ PIK Loan ”). The principal amount of each PIK Loan shall accrue interest in accordance with the provisions of this Agreement applicable to the Loans.

 

(e)           Interest-Only Period . The Interest-Only Period may be extended to the twenty-third (23 rd ) Payment Date if (a) the Borrower’s Revenue resulting from the sale of the Products meets or exceeds $80,000,000 during any consecutive twelve (12) month period on or prior to the twenty-third (23 rd ) Payment Date (the “ Revenue Milestone ”), (b) the Borrower has requested such extension of the Interest-Only Period in writing to the Administrative Agent, (c) the Administrative Agent has received evidence, in form and substance satisfactory to the Administrative Agent in its sole discretion, of the Revenue Milestone, (d) no Default or Event of Default has occurred and is continuing, and (e) the Administrative Agent has provided written confirmation (which for certainty may be in the form of electronic communication) of such extension of the Interest-Only Period, which for certainty shall be provided if conditions (c) and (d) of this Section 3.02(e) have been satisfied.

 

(f)           Interest Act (Canada) . For the purposes of this Agreement, whenever interest is calculated on the basis of a period which is less than the actual number of days in a calendar year (a “ deemed year ”), each rate of interest determined pursuant to such calculation shall, for the purposes of the Interest Act (Canada), be expressed as a yearly rate by multiplying such rate of interest for the deemed year by the actual number of days in the calendar year in which such rate is to be ascertained and dividing the product thereof by the number of days in the deemed year. The Borrower confirms that it and each of the Subsidiary Guarantors understand and is able to calculate the rate of interest applicable to the Loans based on the methodology for calculating per annum rates provided in this Agreement. The Borrower and each Subsidiary Guarantor agree not to plead or assert, whether by way of defence or otherwise, in any proceeding relating to this Agreement or any other Loan Document, that the interest payable under this Agreement or any other Loan Document and the calculation thereof has not been adequately disclosed to the Borrower or the Subsidiary Guarantors as required pursuant to section 4 of the Interest Act (Canada) or any other applicable law.

 

3.03       Prepayments.

 

(a)           Optional Prepayments . Borrower shall have the right to optionally prepay in whole or in part the outstanding principal amount of the Loans on any Payment Date (a “ Redemption Date ”) for an amount equal to the aggregate principal amount of the Loans being prepaid plus the Prepayment Premium plus any accrued but unpaid interest and any fees then due and owing (such aggregate amount, the “ Redemption Price ”). The applicable “ Prepayment Premium ” shall be an amount calculated pursuant to Section 3.03(a)(i) .

 

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(i)           If the Redemption Date occurs:

 

(A)         on or prior to the fourth (4 th ) Payment Date, the Prepayment Premium shall be an amount equal to five percent (5%) of the aggregate outstanding principal amount of the Loans being prepaid on such Redemption Date plus the Backend Facility Fee related to such Loans;

 

(B)         after the fourth (4 th ) Payment Date, but on or prior to the eighth (8 th ) Payment Date, the Prepayment Premium shall be an amount equal to four percent (4%) of the aggregate outstanding principal amount of the Loans being prepaid on such Redemption Date plus the Backend Facility Fee related to such Loans;

 

(C)          after the eighth (8 th ) Payment Date, but on or prior to the twelfth (12 th ) Payment Date, the Prepayment Premium shall be an amount equal to three percent (3%) of the aggregate outstanding principal amount of the Loans being prepaid on such Redemption Date plus the Backend Facility Fee related to such Loans;

 

(D)          after the twelfth (12 th ) Payment Date, but on or prior to the sixteenth (16 th ) Payment Date, the Prepayment Premium shall be an amount equal to two percent (2%) of the aggregate outstanding principal amount of the Loans being prepaid on such Redemption Date plus the Backend Facility Fee related to such Loans;

 

(E)          after the sixteenth (16 th ) Payment Date, but on or prior to the twentieth (20 th ) Payment Date, the Prepayment Premium shall be an amount equal to one percent (1%) of the aggregate outstanding principal amount of the Loans being prepaid on such Redemption Date plus the Backend Facility Fee related to such Loans;

 

(F)          after the twentieth (20 th ) Payment Date, the Prepayment Premium shall be an amount equal to 0.00% of the aggregate outstanding principal amount of the Loans being prepaid on such Redemption Date plus the Backend Facility Fee related to such Loans.

 

(ii)          To determine the aggregate outstanding principal amount of the Loans, and how many Payment Dates have occurred, as of any Redemption Date for purposes of Section 3.03(a) :

 

(A)         if, as of such Redemption Date, Borrower shall have made only one Borrowing, the number of Payment Dates shall be deemed to be the number of Payment Dates that shall have occurred following the first Borrowing Date;

 

(B)          if, as of such Redemption Date, Borrower shall have made more than one Borrowing, then the Redemption Price shall equal the sum of multiple Redemption Prices calculated with respect to the Loans of each Borrowing, each of which Redemption Prices shall be calculated based on solely the aggregate outstanding principal amount of the Loans borrowed in such Borrowing, as though the applicable number of Payment Dates equals the number of Payment Dates that shall have occurred following the applicable Borrowing Date. In the case of any partial prepayment, the amount of such prepayment shall be allocated to Loans made in the various Borrowings in the order in which such Borrowings were made;

 

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(iii)         No partial prepayment shall be made under this Section 3.03(a) in connection with any event described in Section 3.03(b) .

 

(iv)         Borrower shall deliver to the Administrative Agent a notice of optional repayment in accordance with Section 4.03(a) in respect of all prepayments permitted under Section 3.03(a) .

 

(b)           Mandatory Prepayments.

 

(i)            Asset Sales . In the event of any contemplated Asset Sale or series of Asset Sales (other than any Asset Sale permitted under Section 9.09(a) , (b) , (d) or (e) ) yielding Asset Sale Net Proceeds in excess of $1,000,000 in the aggregate, Borrower shall provide 30 days’ prior written notice of such Asset Sale to Administrative Agent and, if within such notice period Majority Lenders or Administrative Agent advise Borrower that the Majority Lenders require a prepayment pursuant to this Section 3.03(b)(i) , Borrower shall: (x) if the assets sold represent substantially all of the assets or revenues of Borrower, or represent any specific line of business which either on its own or together with other lines of business sold over the term of this Agreement account for revenue generated by such lines of business exceeding 10% of the revenue of Borrower in the immediately preceding year, prepay the aggregate outstanding principal amount of the Loans in an amount equal to the Redemption Price applicable on the date of such Asset Sale in accordance with Section 3.03(a) , and (y) in the case of all other Asset Sales not described in the foregoing clause (x) , prepay the Loans in an amount equal to the entire amount of the Asset Sale Net Proceeds of such Asset Sale, plus any accrued but unpaid interest and any fees then due and owing (including for certainty the Backend Facility Fee), credited in the following order:

 

(A)         first, in reduction of Borrower’s obligation to pay any unpaid interest and any fees then due and owing;

 

(B)          second, in reduction of Borrower’s obligation to pay any Claims or Losses referred to in Section 13.03 then due and owing;

 

(C)          third, in reduction of Borrower’s obligation to pay any amounts due and owing on account of the unpaid principal amount of the Loans;

 

(D)          fourth, in reduction of any other Obligation then due and owing;

 

and

 

(E)          fifth, to Borrower or such other Persons as may lawfully be entitled to or directed by Borrower to receive the remainder.

 

(ii)           Change of Control . In the event of a Change of Control, Borrower shall immediately provide notice of such Change of Control to Administrative Agent and, if within ten (10) days of receipt of such notice the Majority Lenders or Administrative Agent advise Borrower that the Majority Lenders require a prepayment pursuant to this Section 3.03(b)(ii) , Borrower shall prepay the aggregate outstanding principal amount of the Loans in an amount equal to the Redemption Price applicable on the date of such Change of Control in accordance with Section 3.03(a) . The Majority Lenders shall use commercially reasonable efforts to review and approve any mergers, amalgamations or other reorganizations resulting from acquisitions which lead to a Change of Control but are materially beneficial to both the Borrower and the Lender’s security interests and rights to the Borrower’s assets, property, rights and interests.

 

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SECTION 4

PAYMENTS, ETC.

 

4.01       Payments.

 

(a)           Payments Generally . Each payment of principal, interest and other amounts to be made by the Obligors under this Agreement or any other Loan Document shall be made in Dollars, in immediately available funds, without deduction, set off or counterclaim, to an account to be designated by Administrative Agent by notice to Borrower, not later than 4:00 p.m. (Central time) on the date on which such payment shall become due (each such payment made after such time on such due date to be deemed to have been made on the next succeeding Business Day).

 

(b)           Application of Payments . Each Obligor shall, at the time of making each payment under this Agreement or any other Loan Document, specify to Administrative Agent the amounts payable by such Obligor hereunder to which such payment is to be applied (and in the event that Obligors fail to so specify, or if an Event of Default has occurred and is continuing, the Lenders may apply such payment in the manner they determine to be appropriate).

 

(c)           Non-Business Days . If the due date of any payment under this Agreement (other than of principal of or interest on the Loans) would otherwise fall on a day that is not a Business Day, such date shall be extended to the next succeeding Business Day, and, in the case of any payment accruing interest, interest thereon shall be payable for the period of such extension.

 

4.02       Computations. All computations of interest and fees hereunder shall be computed on the basis of a year of 360 days and actual days elapsed during the period for which payable.

 

4.03       Notices. Each notice of optional prepayment shall be effective only if received by Administrative Agent not later than 4:00 p.m. (Central time) on the date one Business Day prior to the date of prepayment. Each notice of optional prepayment shall specify the amount to be prepaid and the date of prepayment.

 

4.04       Set-Off.

 

(a)           Set-Off Generally . Upon the occurrence and during the continuance of any Event of Default, each of Administrative Agent, each Lender and each of their Affiliates is hereby authorized at any time and from time to time, to the fullest extent permitted by law, to set off and apply any and all deposits (general or special, time or demand, provisional or final) at any time held and other indebtedness at any time owing by Administrative Agent, any Lender and any of their Affiliates to or for the credit or the account of any Obligor against any and all of the Obligations, whether or not such Person shall have made any demand and although such obligations may be unmatured. Administrative Agent and each Lender agree promptly to notify Borrower after any such set-off and application, provided that the failure to give such notice shall not affect the validity of such set-off and application. The rights of Administrative Agent, each Lender and each of their Affiliates under this Section 4.04 are in addition to other rights and remedies (including other rights of set-off) that such Persons may have.

 

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(b)           Exercise of Rights Not Required . Nothing contained herein shall require Administrative Agent, any Lender or any of their respective Affiliates to exercise any such right or shall affect the right of such Person to exercise, and retain the benefits of exercising, any such right with respect to any other indebtedness or obligation of any Obligor.

 

4.05       Pro Rata Treatment.

 

(a)          Unless Administrative Agent shall have been notified in writing by any Lender prior to the proposed date of any Borrowing that such Lender will not make the amount that would constitute its share of such Borrowing available to Administrative Agent, Administrative Agent may assume that such Lender has made such amount available to Administrative Agent on such date in accordance with Section 2 , and Administrative Agent may, in reliance upon such assumption, make available to Borrower a corresponding amount. If such amount is not in fact made available to Administrative Agent by the required time on the applicable Borrowing Date therefor, such Lender and Borrower severally agree to pay to Administrative Agent forthwith, on demand, such corresponding amount with interest thereon, for each day from and including the date on which such amount is made available to Borrower but excluding the date of payment to Administrative Agent, at (i) in the case of a payment to be made by such Lender, a rate equal to the greater of (A) the Federal Funds Effective Rate and (B) a rate reasonably determined by Administrative Agent in accordance with banking industry rules on interbank compensation. If Borrower and such Lender shall pay such interest to Administrative Agent for the same or an overlapping period, Administrative Agent shall promptly remit to Borrower the amount of such interest paid by Borrower for such period. If such Lender pays its share of the applicable borrowing to Administrative Agent, then the amount so paid shall constitute such Lender’s Loan included in such borrowing. Any payment by Borrower shall be without prejudice to any claim Borrower may have against a Lender that shall have failed to make such payment to Administrative Agent.

 

(b)          Unless Administrative Agent shall have received notice from Borrower prior to the date on which any payment is due to Administrative Agent for the account of the Lenders hereunder that Borrower will not make such payment, Administrative Agent may assume that Borrower has made such payment on such date in accordance herewith and may, in reliance upon such assumption, distribute to the Lenders the amount due. In such event, if Borrower has not in fact made such payment, then each of the Lenders severally agrees to repay to Administrative Agent forthwith on demand the amount so distributed to such Lender, with interest thereon, for each day from and including the date such amount is distributed to it to but excluding the date of payment to Administrative Agent, at the greater of the Federal Funds Effective Rate and a rate determined by Administrative Agent in accordance with banking industry rules on interbank compensation. Nothing herein shall be deemed to limit the rights of Administrative Agent or any Lender against any Obligor.

 

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(c)          If any Lender shall obtain any payment (whether voluntary, involuntary, through the exercise of any right of set-off, or otherwise) on account of the principal of or interest on any Loan made by it or other obligations hereunder, as applicable (other than pursuant to a provision hereof providing for non-pro rata treatment), in excess of its Proportionate Share, of such payment on account of the Loans, such Lender shall (i) notify Administrative Agent of the receipt of such payment, and (ii) within five (5) Business Days of such receipt purchase (for cash at face value) from the other Lenders, as applicable (directly or through Administrative Agent), without recourse, such participations in the Loans made by them or make such other adjustments as shall be equitable, as shall be necessary to cause such purchasing Lender to share the excess payment ratably with each of the other Lenders in accordance with their respective Proportionate Shares, as applicable; provided, however, that (A) if any such participations are purchased and all or any portion of the payment giving rise thereto is recovered, such participations shall be rescinded and the purchase price restored to the extent of such recovery, without interest and (B) the provisions of this paragraph shall not be construed to apply to (x) any payment made by Borrower pursuant to and in accordance with the express terms of this Agreement (including the application of funds arising from the existence of a Defaulting Lender) or (y) any payment obtained by a Lender as consideration for the assignment or sale of a participation in any of its Loans to any assignee or participant, other than to Borrower or any of its Affiliates (as to which the provisions of this paragraph shall apply). Borrower agrees that any Lender so purchasing a participation from another Lender pursuant to this Section 4.05(c) may exercise all its rights of payment (including the right of set-off) with respect to such participation as fully as if such Lender were the direct creditor of Borrower in the amount of such participation. No documentation other than notices and the like referred to in this Section 4.05(c) shall be required to implement the terms of this Section 4.05(c) . Administrative Agent shall keep records (which shall be conclusive and binding in the absence of manifest error) of participations purchased pursuant to this Section 4.05(c) and shall in each case notify the Lenders following any such purchase. Borrower consents on behalf of itself and each other Obligor to the foregoing and agrees, to the extent it may effectively do so under applicable law, that any Lender acquiring a participation pursuant to the foregoing arrangements may exercise against each Obligor rights of setoff and counterclaim with respect to such participation as fully as if such Lender were a direct creditor of each Obligor in the amount of such participation.

 

SECTION 5

YIELD PROTECTION, ETC.

 

5.01       Additional Costs.

 

(a)           Change in Requirements of Law Generally . If, on or after the date hereof, the adoption of any Requirement of Law, or any change in any Requirement of Law, or any change in the interpretation or administration thereof by any court or other Governmental Authority charged with the interpretation or administration thereof, or compliance by any of the Lenders (or its lending office) with any request or directive (whether or not having the force of law) of any such Governmental Authority, shall impose, modify or deem applicable any reserve (including any such requirement imposed by the Board of Governors of the Federal Reserve System), special deposit, contribution, insurance assessment or similar requirement, in each case that becomes effective after the date hereof, against assets of, deposits with or for the account of, or credit extended by, a Lender (or its lending office) or shall impose on a Lender (or its lending office) any other condition affecting the Loans or the Commitment, and the result of any of the foregoing is to increase the cost to such Lender of making or maintaining the Loans (other than (i) Indemnified Taxes and (ii) Taxes described in clause (c) , (d) or (f) of the definition of “Excluded Taxes”), or to reduce the amount of any sum received or receivable by such Lender under this Agreement or any other Loan Document, by an amount deemed by such Lender to be material, then Borrower shall pay to such Lender on demand such additional amount or amounts as will compensate such Lender for such increased cost or reduction.

 

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(b)           Change in Capital Requirements . If a Lender shall have determined that, on or after the date hereof, the adoption of any Requirement of Law regarding capital adequacy, or any change therein, or any change in the interpretation or administration thereof by any Governmental Authority charged with the interpretation or administration thereof, or any request or directive regarding capital adequacy (whether or not having the force of law) of any such Governmental Authority, in each case that becomes effective after the date hereof, has or would have the effect of reducing the rate of return on capital of a Lender (or its parent) as a consequence of a Lender’s obligations hereunder or the Loans to a level below that which a Lender (or its parent) could have achieved but for such adoption, change, request or directive by an amount reasonably deemed by it to be material, then Borrower shall pay to such Lender on demand such additional amount or amounts as will compensate such Lender (or its parent) for such reduction.

 

(c)           Notification by Lender . Each Lender (directly or through Administrative Agent) will promptly notify Borrower of any event of which it has knowledge, occurring after the date hereof, which will entitle such Lender to compensation pursuant to this Section 5.01 . Before giving any such notice pursuant to this Section 5.01(c) such Lender shall designate a different lending office if such designation (x) will, in the reasonable judgment of such Lender, avoid the need for, or reduce the amount of, such compensation and (y) will not, in the reasonable judgment of such Lender, be materially disadvantageous to such Lender. A certificate of the Lender claiming compensation under this Section 5.01 , setting forth the additional amount or amounts to be paid to it hereunder, shall be conclusive and binding on Borrower in the absence of manifest error.

 

(d)          Notwithstanding anything herein to the contrary, (x) the Dodd-Frank Wall Street Reform and Consumer Protection Act and all requests, rules, guidelines or directives thereunder or issued in connection therewith and (y) all requests, rules, guidelines or directives promulgated by the Bank for International Settlements, the Basel Committee on Banking Supervision (or any successor or similar authority) or the United States or foreign regulatory authorities, in each case pursuant to Basel III, shall in each case be deemed to constitute a change in Requirements of Law for all purposes of this Section 5.01 , regardless of the date enacted, adopted or issued.

 

5.02       Illegality. Notwithstanding any other provision of this Agreement, in the event that on or after the date hereof the adoption of or any change in any Requirement of Law or in the interpretation or application thereof by any competent Governmental Authority shall make it unlawful for a Lender or its lending office to make or maintain the Loans (and, in the opinion of such Lender, the designation of a different lending office would either not avoid such unlawfulness or would be disadvantageous to such Lender), then such Lender shall promptly notify Borrower thereof following which (a) the Lender’s Commitment shall be suspended until such time as such Lender may again make and maintain the Loans hereunder and (b) if such Requirement of Law shall so mandate, the Loans shall be prepaid by Borrower on or before such date as shall be mandated by such Requirement of Law in an amount equal to the Redemption Price applicable on the date of such prepayment in accordance with Section 3.03(a) .

 

5.03       Taxes .

 

(a)           Payments Free of Taxes . Any and all payments by or on account of any Obligation shall be made without deduction or withholding for any Taxes, except as required by applicable law. If any applicable law requires the deduction or withholding of any Tax from any such payment by an Obligor, then such Obligor shall be entitled to make such deduction or withholding and shall timely pay the full amount deducted or withheld to the relevant Governmental Authority in accordance with applicable law and, if such Tax is an Indemnified Tax, then the sum payable by such Obligor shall be increased as necessary so that after such deduction or withholding has been made (including such deductions and withholdings applicable to additional sums payable under this Section 5 ) the applicable Recipient receives an amount equal to the sum it would have received had no such deduction or withholding been made.

 

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(b)           Payment of Other Taxes by Borrower . Borrower shall timely pay to the relevant Governmental Authority in accordance with applicable law, or at the option of each Lender, timely reimburse it for, Other Taxes.

 

(c)           Evidence of Payments . As soon as practicable after any payment of Taxes by Borrower to a Governmental Authority pursuant to this Section 5 , Borrower shall deliver to Administrative Agent the original or a certified copy of a receipt issued by such Governmental Authority evidencing such payment.

 

(d)           Indemnification . Borrower shall reimburse and indemnify each Recipient, within 10 days after demand therefor, for the full amount of any Indemnified Taxes (including Indemnified Taxes imposed or asserted on or attributable to amounts payable under this Section 5 ) payable or paid by such Recipient or required to be withheld or deducted from a payment to such Recipient and any reasonable expenses arising therefrom or with respect thereto, whether or not such Indemnified Taxes were correctly or legally imposed or asserted by the relevant Governmental Authority. A certificate as to the amount of such payment or liability delivered to Borrower by a Lender shall be conclusive absent manifest error.

 

(e)           Status of Lenders .

 

(i)           Any Lender that is entitled to an exemption from, or reduction of withholding Tax with respect to payments made under any Loan Document shall timely deliver to Borrower (directly or through Administrative Agent) such properly completed and executed documentation reasonably requested by Borrower as will permit such payments to be made without withholding or at a reduced rate of withholding; provided that, other than in the case of United States federal withholding Taxes, such Lender has received written notice from Borrower advising it of the availability of such exemption or reduction and containing all applicable documentation. In addition, any Lender shall deliver (directly or through Administrative Agent) such other documentation prescribed by applicable law as reasonably requested by Borrower as will enable Borrower to determine whether or not such Lender is subject to backup withholding or information reporting requirements. Notwithstanding anything to the contrary in the preceding two sentences, the completion, execution and submission of such documentation (other than such documentation set forth in Section 5.03(e)(ii)(A) , (B) , (C) or (D) ) shall not be required if in the Lender’s reasonable judgment such completion, execution or submission would subject such Lender to any material unreimbursed cost or expense or would materially prejudice the legal or commercial position of such Lender.

 

(ii)          Without limiting the generality of the foregoing, in the event that Borrower is a U.S. Person:

 

(A)         any Lender that is a U.S. Person shall deliver to Borrower (directly or through Administrative Agent) on or prior to the date on which such Lender becomes a Lender under this Agreement (and from time to time thereafter upon the reasonable request of Borrower), executed originals of IRS Form W-9 (or successor form) certifying that such Lender is exempt from United States federal backup withholding tax;

 

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(B)          any Foreign Lender shall, to the extent it is legally entitled to do so, deliver to Borrower (directly or through Administrative Agent and in such number of copies as shall be requested by the recipient) on or prior to the date on which such Foreign Lender becomes a Lender under this Agreement (and from time to time thereafter upon the reasonable request of Borrower), whichever of the following is applicable:

 

(1)         in the case of a Foreign Lender claiming the benefits of an income tax treaty to which the United States is a party (x) with respect to payments of interest under any Loan Document, executed originals of IRS Form W-8BEN or W-8BEN-E (or successor forms) establishing an exemption from, or reduction of, United States federal withholding Tax pursuant to the “interest” article of such tax treaty and (y) with respect to any other applicable payments under any Loan Document, IRS Form W-8BEN or W-8BEN-E (or successor forms) establishing an exemption from, or reduction of, United States federal withholding Tax pursuant to the “business profits” or “other income” article of such tax treaty;

 

(2)         executed originals of IRS Form W-8ECI (or successor form);

 

(3)         in the case of a Foreign Lender claiming the benefits of the exemption for portfolio interest under Section 881(c) of the Code, (x) a certificate substantially in the form of Exhibit G to the effect that such Foreign Lender is not a “bank” within the meaning of Section 881(c)(3)(A) of the Code, a “10 percent shareholder” of the applicable Borrower within the meaning of Section 881(c)(3)(B) of the Code, or a “controlled foreign corporation” described in Section 881(c)(3)(C) of the Code and (y) executed originals of IRS Form W-8BEN or W-8BEN-E (or successor forms); or

 

(4)         to the extent a Foreign Lender is not the beneficial owner, executed originals of IRS Form W-8IMY (or successor form), accompanied by IRS Form W-8ECI (or successor form), IRS Form W-8BEN or W-8BEN-E (or successor forms), IRS Form W-9 (or successor form), and/or other certification documents from each beneficial owner, as applicable; provided that if the Foreign Lender is a partnership and one or more direct or indirect partners of such Foreign Lender are claiming the portfolio interest exemption, such Foreign Lender may provide a certificate substantially in the form of Exhibit C on behalf of each such direct and indirect partner.

 

(C)          any Foreign Lender shall, to the extent it is legally entitled to do so, deliver to Borrower (directly or through Administrative Agent and in such number of copies as shall be requested by the recipient) on or prior to the date on which such Foreign Lender becomes a Lender under this Agreement (and from time to time thereafter upon the reasonable request of Borrower), executed originals of any other form prescribed by applicable law as a basis for claiming exemption from or a reduction in United States federal withholding Tax, duly completed, together with such supplementary documentation as may be prescribed by applicable law to permit Borrower to determine the withholding or deduction required to be made; and

 

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(D)          any Foreign Lender shall deliver to Borrower (directly or through Administrative Agent) any forms and information necessary to establish that such Foreign Lender is not subject to withholding tax under FATCA.

 

Each Lender agrees that if any form or certification it previously delivered expires or becomes obsolete or inaccurate in any respect, it shall update such form or certification or promptly notify Borrower in writing of its legal inability to do so.

 

(f)            Treatment of Certain Refunds . If any party determines, in its sole discretion exercised in good faith, that it has received a refund of any Taxes as to which it has been indemnified pursuant to this Section 5 (including by the payment of additional amounts pursuant to this Section 5 ), it shall pay to the indemnifying party an amount equal to such refund (but only to the extent of indemnity payments made under this Section 5 with respect to the Taxes giving rise to such refund), net of all out-of-pocket expenses (including Taxes) of such indemnified party and without interest (other than any interest paid by the relevant Governmental Authority with respect to such refund). Such indemnifying party, upon the request of such indemnified party, shall repay to such indemnified party the amount paid over pursuant to this paragraph (plus any penalties, interest or other charges imposed by the relevant Governmental Authority) in the event that such indemnified party is required to repay such refund to such Governmental Authority. Notwithstanding anything to the contrary in this Section 5.03(f) , in no event will the indemnified party be required to pay any amount to an indemnifying party pursuant to this Section 5.03(f) the payment of which would place the indemnified party in a less favorable net after-Tax position than the indemnified party would have been in if the Tax subject to indemnification and giving rise to such refund had not been deducted, withheld or otherwise imposed and the indemnification payments or additional amounts with respect to such Tax had never been paid. This Section 5.03(f) shall not be construed to require any indemnified party to make available its Tax returns (or any other information relating to its Taxes that it deems confidential) to the indemnifying party or any other Person.

 

(g)          Mitigation Obligations . If Borrower is required to pay any Indemnified Taxes or additional amounts to any Lender or to any Governmental Authority for the account of any Lender pursuant to Section 5.01 or this Section 5.03 , then such Lender shall (at the request of Borrower) use commercially reasonable efforts to designate a different lending office for funding or booking its Loans hereunder or to assign and delegate its rights and obligations hereunder to another of its offices, branches or Affiliates if, in the sole reasonable judgment of such Lender, such designation or assignment and delegation would (i) eliminate or reduce amounts payable pursuant to Section 5.01 or this Section 5.03 , as the case may be, in the future, (ii) not subject such Lender to any unreimbursed cost or expense and (iii) not otherwise be disadvantageous to such Lender. Borrower hereby agrees to pay all reasonable costs and expenses incurred by any Lender in connection with any such designation or assignment and delegation.

 

SECTION 6

CONDITIONS PRECEDENT

 

6.01 The First Borrowing. The first Borrowing was made conditional upon the following conditions precedent that were satisfied or waived in writing by the Lenders:

 

(a)           Borrowing Date . The first Borrowing was made on June 14, 2016 and remains outstanding as of the date hereof.

 

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(b)          Amount of First Borrowing . The amount of such Borrowing shall equal $20,000,000.

 

(c)           Terms of Material Agreements, Etc . Lenders shall be reasonably satisfied with the terms and conditions of all of the Obligors’ Material Agreements.

 

(d)           No Law Restraining Transactions . No applicable law or regulation shall restrain, prevent or, in the reasonable judgment of the Lenders, impose materially adverse conditions upon the Transactions.

 

(e)           Payment of Fees . Lenders shall be satisfied with the arrangements to deduct the fees set forth in the Fee Letter (including without limitation the upfront financing fee required pursuant to the Fee Letter) from the proceeds advanced.

 

(f)           Lien Searches . (i) Lenders shall be satisfied with Lien searches regarding Borrower and the Subsidiary Guarantors (other than the English Obligors or a Subsidiary Guarantor incorporated or organized in Germany) made within:

 

(A)         five (5) Business Days prior to such Borrowing in the case of the Borrower; and

 

(B)          fifteen (15) days prior to such Borrowing in the case of each Obligor organized in the United States of America or any state or political subdivision thereof; and

 

(ii)          Lenders shall be satisfied with an excerpt from the Debt Enforcement Registry in respect of each Obligor incorporated in Switzerland or any state or political subdivison thereof, dated no less than 30 days prior to such Borrowing; and

 

(iii)         Lenders shall be satisfied with searches regarding the English Obligors made on the date of this Agreement.

 

(g)           Documentary Deliveries . The Lenders shall have received the following documents, each of which shall be in form and substance satisfactory to the Lenders:

 

(i)            License Agreement . A duly executed license agreement in form and substance satisfactory to the Administrative Agent between Durata Therapeutics International B.V. and Correvio International Sárl relating to Dalbavancin.

 

(ii)           Fee Letter . The Fee Letter duly executed and delivered by Borrower and Administrative Agent.

 

(iii)          Security Documents .

 

(A)         The Security Documents (other than the Landlord Consent), duly executed and delivered by each of the Obligors.

 

(B)          (1) Each of the Short-Form IP Security Agreements, duly executed and delivered by the applicable Obligor, and (2) such Intellectual Property security agreements, duly executed and delivered by the applicable Obligor, as the Lenders may require with respect to foreign Intellectual Property.

 

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(C)         [Intentionally Deleted.].

 

(D)         [Intentionally Deleted.].

 

(E)          Evidence of filing of UCC-1 financing statements, PPSA financing statements or similar registrations, if applicable, against each Obligor (other than the English Obligors, an Obligor incorporated or organized in Germany or with respect to registrations noted on Schedule 8.17 ) in its jurisdiction of formation or incorporation, the jurisdictions in which its chief executive office and registered office are located and/or the jurisdiction where it has assets or carries on business, as the case may be.

 

(F)          [Intentionally Deleted.]

 

(G)          Without limitation, all other documents and instruments reasonably required to perfect the Secured Parties’ Lien on, and security interest in, the Collateral required to be delivered on or prior to such Borrowing Date shall have been duly executed and delivered and be in proper form for filing, and shall create in favor of the Secured Parties, a perfected Lien on, and security interest in, the Collateral, subject to no Liens other than Permitted Liens.

 

(iv)         [Intentionally Deleted.]

 

(v)           Approvals . Certified copies of all material licenses, consents, authorizations and approvals of, and notices to and filings and registrations with, any Governmental Authority (including all foreign exchange approvals), and of all third-party consents and approvals, necessary in connection with the making and performance by the Obligors of the Loan Documents and the Transactions.

 

(vi)          Corporate Documents . Certified copies of the constitutive documents of each Obligor (if publicly available in such Obligor’s jurisdiction of formation, certified copies from such public institution or in the case of any Obligor incorporated or organized in Germany or Switzerland where up- to-date copies retrieved from the online commercial register shall be sufficient), of resolutions of the Board of Directors (or shareholders, if applicable) of each Obligor authorizing the making and performance by it of the Loan Documents to which it is a party and a certified true and complete copy of the Borrower’s investment policy.

 

(vii)         Incumbency Certificate . A certificate (which, for certainty, can be combined with the certificate required pursuant to Section 6.01(g)(vi) above) of each Obligor (except for an Obligor incorporated or organized in Germany) as to the authority, incumbency and specimen signatures of the persons who have executed the Loan Documents and any other documents in connection herewith on behalf of the Obligors. In relation to an Obligor incorporated or organized in Germany, (i) a certificate signed by an authorized signatory with the power of representation certifying that each document delivered under clause 6.01(g)(vi) above is correct, complete and in full force and effect and has not been amended or superseded as at the date of the certificate and (ii) the specimen signatures of each person authorized to execute any Loan Document.

 

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(viii)        Officer’s Certificate . A certificate, dated such Borrowing Date and signed by the President, a Vice President or a financial officer of Borrower, confirming compliance with the conditions set forth in Section 6.04 .

 

(ix)           Opinions of Counsel . Favorable opinions, dated such Borrowing Date, in form acceptable to the Lenders and their counsel, as may include the requests set forth in Exhibit E , provided by:

 

(A)         Blake, Cassels & Graydon LLP, in respect of matters of relating to Canadian law and/or any Obligor organized in Canada or any province or territory thereof;

 

(B)          Skadden, Arps, Slate, Meagher & Flom LLP, in respect of matters relating to United States law and/or any Obligor organized in the United States of America or any state or political subdivision thereof;

 

(C)           Baker & McKenzie LLP, in respect of matters relating to English law and/or any Obligor organized in England and Wales or any state or political subdivision thereof;

 

(D)          Baker & McKenzie Partnerschaft von Rechtsanwaelten, Wirtschaftspruefern und Steuerberatern mbB, in respect of certain matters relating to German law or any state or political subdivision thereof;

 

(E)          Allen & Overy LLP, in respect of certain matters relating to German law, including corporate matters, relating to any Obligor organized in Germany or any state or political subdivision thereof; and

 

(F)          Staiger Schwald & Partner Ltd., in respect of matters relating to the law of Switzerland and/or any Obligor organized in Switzerland or any state or political subdivision thereof.

 

(x)            Insurance . Certificates of insurance evidencing the existence of all insurance required to be maintained by Borrower pursuant to Section 8.05 and the designation of the Lenders as the lender’s loss payees or additional named insured, as the case may be, thereunder.

 

(xi)         [Intentionally Deleted.]

 

(xii)         Other Liens . Duly executed and delivered copies of such acknowledgement letters, estoppel letters or similar instruments as are reasonably requested by Administrative Agent with respect to existing Liens.

 

(xiii)       [Intentionally Deleted.]

 

(xiv)        Existing Indebtedness . Borrower shall have delivered to the Administrative Agent a payout and discharge statement, in form and substance satisfactory to the Administrative Agent, in respect of all Indebtedness owing by the Borrower and any Subsidiary guarantor to MidCap, together with all required draft UCC termination statements, draft PPSA discharge statements and any other related instruments.

 

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(xv)         Good Standing Certificates . A certificate from the appropriate Governmental Authority bearing a current date acceptable to the Administrative Agent, to the effect that each Obligor (other than any English Obligor or any Obligor incorporated or organized in Germany or Switzerland) is in good standing and qualified to transact business in its jurisdiction of organization and in each other jurisdiction where it transacts business.

 

6.02       Conditions to Second Borrowing. The second Borrowing was made conditional upon the following conditions precedent that were satisfied or waived in writing by the Lenders:

 

(a)           Borrowing Date . The second Borrowing occurred on the First Restatement Date and remains outstanding as of the date hereof.

 

(b)           Amount of Borrowing . The amount of such Borrowing shall equal $10,000,000.

 

(c)           Terms of Material Agreements, Etc . Lenders shall be reasonably satisfied with the terms and conditions of all of the Obligors’ Material Agreements.

 

(d)           No Law Restraining Transactions . No applicable law or regulation shall restrain, prevent or, in the reasonable judgment of the Lenders, impose materially adverse conditions upon the Transactions.

 

(e)           Payment of Fees . Lenders shall be satisfied with the arrangements to deduct the fees payable upon the second Borrowing set forth in the Fee Letter (including without limitation the upfront financing fee required pursuant to the Fee Letter) from the proceeds advanced.

 

(f)           Lien Searches . Lenders shall be satisfied with Lien searches regarding the Borrower and its respective Subsidiaries (other than the English Obligors, the Swiss Guarantors or a Subsidiary Guarantor incorporated or organized in Germany) made within two Business Days prior to such Borrowing.

 

(g)           Documentary Deliveries . The Lenders shall have received the following documents, each of which shall be in form and substance satisfactory to the Lenders:

 

(i)            Fee Letter . An amended Fee Letter in form and substance satisfactory to the Lenders duly executed and delivered by Borrower and Administrative Agent.

 

(ii)           Warrants . For the Lenders, pro rata in accordance with their Proportionate Shares, the Warrants, duly executed by Borrower (for such number of shares as indicated on Schedule 1 ).

 

(iii)          Security Documents . Without limitation, all documents and instruments reasonably required to perfect the Secured Parties’ Lien on, and security interest in, the Collateral required to be delivered on or prior to such Borrowing Date shall have been duly executed and delivered and be in proper form for filing, and shall create in favor of the Secured Parties, a perfected Lien on, and security interest in, the Collateral, subject to no Liens other than Permitted Liens.

 

(iv)          Approvals . Certified copies of all material licenses, consents, authorizations and approvals of, and notices to and filings and registrations with, any Governmental Authority (including all foreign exchange approvals), and of all third-party consents and approvals, necessary in connection with the making and performance by the Obligors of the Loan Documents and the Transactions.

 

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(v)           Corporate Documents . Certified copies of the constitutive documents of each Obligor (if publicly available in such Obligor’s jurisdiction of formation, certified copies from such public institution), or an officer’s certificate certifying that no changes have been made to such constitutive documents since the Original Closing Date (or in the case of any Obligor incorporated or organized in Germany or Switzerland where up-to-date copies retrieved from the online commercial register shall be sufficient), and of resolutions of the Board of Directors (or shareholders, if applicable) of each Obligor authorizing the making and performance by it of the Loan Documents to be entered into on the First Restatement Date and pursuant to Section 8.17 of the First A&R Agreement to which it is a party.

 

(vi)          Incumbency Certificate. A certificate (which, for certainty, can be combined with the certificate required pursuant to Section 6.02(g)(v) of the First A&R Agreement) of each Obligor (except for an Obligor incorporated or organized in Germany) as to the authority, incumbency and specimen signatures of the persons who have executed the Loan Documents and any other documents in connection herewith on behalf of the Obligors. In relation to an Obligor incorporated or organized in Germany, (i) a certificate signed by an authorized signatory with the power of representation certifying that each document delivered under clause 6.02(g)(v) of the First A&R Agreement is correct, complete and in full force and effect and has not been amended or superseded as at the date of the certificate and (ii) the specimen signatures of each person authorized to execute any Loan Document.

 

(vii)         Officer’s Certificate . A certificate, dated such Borrowing Date and signed by the President, a Vice President or a financial officer of Borrower, confirming compliance with the conditions set forth in Section 6.05 of the First A&R Agreement.

 

(viii)        Good Standing Certificates . A certificate from the appropriate Governmental Authority, bearing a current date acceptable to the Administrative Agent, to the effect that each Obligor (other than any English Obligor or any Obligor incorporated or organized in Germany or Switzerland) is in good standing and qualified to transact business in its jurisdiction of organization and in each other jurisdiction where it transacts business.

 

6.03       Conditions to Third Borrowing. The third Borrowing was made conditional upon the following conditions precedent that were satisfied or waived in writing by the Lenders: Borrowing Date . The third Borrowing occurred on August 8, 2017 and remains outstanding as of the date hereof.

 

(b)           Amount of Borrowing . The amount of such Borrowing shall equal $10,000,000.

 

(c)           Third Borrowing Milestone . Confirmation that (i) average Market Capitalization for the consecutive ninety (90) calendar days immediately preceding the date of the third Borrowing was at least $90,000,000 and (ii) at no time during such ninety (90) calendar day period has the Market Capitalization been equal to or less than $85,000,000 (collectively, the “ Third Borrowing Milestone ”), provided that the Third Borrowing Milestone shall be achieved in time to provide the Administrative Agent with a Notice of Borrowing in compliance with Section 2.02 of the First A&R Agreement and Section 6.03(a) of the First A&R Agreement.

 

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(d)           Notice of Milestone Achievement . Borrower shall have delivered to Administrative Agent a notice certifying satisfaction of the condition set forth in Section 6.03(c) of the First A&R Agreement no later than 60 days thereafter, and the Lenders shall have been reasonably satisfied with the accuracy of the information contained in such notice.

 

(e)           Notice of Borrowing . A Notice of Borrowing shall have been received no later than 60 calendar days after satisfaction of the condition set forth in Section 6.03(c) of the First A&R Agreement.

 

(f)           Payment of Fees . Lenders shall be satisfied with the arrangements to deduct the fees payable upon the third Borrowing set forth in the Fee Letter (including without limitation the upfront financing fee required pursuant to the Fee Letter) from the proceeds advanced.

 

(g)           Post-Closing Items . Satisfaction of the condition set forth in Section 8.17 of the First A&R Agreement.

 

6.04       Conditions to Fourth Borrowing . The obligation of each Lender to make a Loan as part of a fourth Borrowing is subject to the following conditions precedent, which shall have been satisfied or waived in writing by the Lenders:

 

(a)           Borrowing Date . The fourth Borrowing shall occur following receipt by the Administrative Agent of the Notice of Borrowing referred to in Section 6.04(e) .

 

(b)           Amount of Borrowing . The amount of such Borrowing shall be in one advance of either $5,000,000 or $10,000,000. For certainty, if Borrower elects a $5,000,000 advance, Borrower may not receive any further Borrowing under this Section 6.04(b) .

 

(c)           Fourth Borrowing Milestone . Confirmation that the Borrower’s Revenue from the sale of the Products has exceeded $35,000,000 during any consecutive twelve (12) month period (the “ Fourth Borrowing Milestone ”), provided that the Fourth Borrowing Milestone shall be achieved no later than March 31, 2018 unless the Administrative Agent extends such deadline in its sole discretion in connection with a proposed Transaction.

 

(d)           Notice of Milestone Achievement and Audit . Borrower shall have delivered to Administrative Agent a notice certifying satisfaction of the condition set forth in Section 6.04(c) no later than 60 days thereafter, and the Lenders shall have been reasonably satisfied with the results of its audit of Borrower’s Revenue by examining Borrower’s books and records.

 

(e)           Notice of Borrowing . A Notice of Borrowing shall have been received no later than 60 calendar days after satisfaction of the condition set forth in Section 6.04(c) .

 

(f)           Payment of Fees . Lenders shall be satisfied with the arrangements to deduct the fees payable upon the fourth Borrowing set forth in the Fee Letter (including without limitation the upfront financing fee required pursuant to the Fee Letter) from the proceeds advanced.

 

(g)           Post-Closing Items . Satisfaction of the condition set forth in Section 8.17 of the First A&R Agreement.

 

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6.05       Conditions to Each Borrowing . The obligation of each Lender to make a Loan as part of any Borrowing (including the first Borrowing) is also subject to satisfaction of the following further conditions precedent on the applicable Borrowing Date, which shall have been satisfied or waived in writing by the Lenders:

 

(a)           Commitment Period . Such Borrowing Date shall occur during the Commitment Period.

 

(b)           No Default; Representations and Warranties . Both immediately prior to the making of such Loan and after giving effect thereto and to the intended use thereof:

 

(i)           no Default shall have occurred and be continuing; and

 

(ii)          the representations and warranties made by each Obligor in Section 7 shall be true on and as of the Borrowing Date, and immediately after giving effect to the application of the proceeds of the Borrowing, with the same force and effect as if made on and as of such date (except that the representation regarding representations and warranties that refer to a specific earlier date shall be that they were true on such earlier date).

 

(c)           Notice of Borrowing . Administrative Agent shall have received a Notice of Borrowing as and when required pursuant to Section 2.02 .

 

Each Borrowing shall constitute a certification by Borrower to the effect that the conditions set forth in this Section 6.04 have been fulfilled as of the applicable Borrowing Date.

 

6.06       Conditions to the effectiveness of this Agreement. The effectiveness of this Agreement is subject to the following conditions precedent, which shall have been satisfied or waived in writing by the Lenders:

 

(a)           Terms of Material Agreements, Etc . Lenders shall be reasonably satisfied with the terms and conditions of all of the Obligors’ Material Agreements.

 

(b)          No Law Restraining Transactions . No applicable law or regulation shall restrain, prevent or, in the reasonable judgment of the Lenders, impose materially adverse conditions upon the Transactions.

 

(c)           Payment of Fees . Lenders shall be satisfied with the arrangements by Borrower to pay all fees and expenses on the Closing Date (including, without limitation, legal fees) described in Section 13.03 of this Agreement.

 

(d)           Lien Searches . Lenders shall be satisfied with Lien searches regarding the Borrower and its respective Subsidiaries (other than the English Obligors, the Swiss Guarantors or a Subsidiary Guarantor incorporated or organized in Germany) made within two Business Days prior to the Closing Date or such earlier period agreed to by the Agent.

 

(e)           Documentary Deliveries . The Lenders shall have received the following documents, each of which shall be in form and substance satisfactory to the Lenders:

 

(i)            Fee Letter . A second amended and restated Fee Letter in form and substance satisfactory to the Lenders duly executed and delivered by Borrower and Administrative Agent.

 

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(ii)           Assignment Agreement . The Assignment Agreement in form and substance satisfactory to the Lenders duly executed and delivered by Original Borrower, Borrower, Subsidiary Guarantors and Administrative Agent.

 

(iii)          Warrants . A warrant assumption agreement with respect to the Warrants being applicable to the Borrower duly executed and delivered by Borrower, Original Borrower and the Lenders, in form and substance satisfactory to the Lenders.

 

(iv)          Security Documents .

 

(A)          The Security Documents, duly executed and delivered by each of the Obligors, to the extent not delivered on the Original Closing Date or the First Restatement Date or as otherwise required in connection with this Agreement, as the case may be.

 

(B)          (1) Each of the Short-Form IP Security Agreements, duly executed and delivered by the applicable Obligor, and (2) such Intellectual Property security agreements, duly executed and delivered by the applicable Obligor, as the Lenders may require with respect to foreign Intellectual Property, to the extent not previously delivered or as otherwise required in connection with this Agreement, as the case may be.

 

(C)          Evidence of filing of PPSA financing statements or similar registrations, if applicable, against the Borrower and Correvio Canada Corp., in each applicable jurisdiction of formation or incorporation, the jurisdictions in which its chief executive office and registered office are located and/or the jurisdiction where it has assets or carries on business, as the case may be.

 

(D)          A contract transfer agreement between the Original Borrower, the Borrower and the Administrative Agent (acting as security agent), providing (inter alia) for the assumption by the Borrower, with the Administrative Agent's consent, of the contractual position of the Original Borrower under the share pledge agreement dated June 13, 2016, between the Original Borrower and the Administrative Agent in relation to the shares in Cardiome International SA (the “ Swiss Share Pledge Transfer Agreement ”).

 

(E)          Without limitation, all other documents and instruments reasonably required to perfect the Secured Parties’ Lien on, and security interest in, the Collateral required to be delivered on or prior to the Closing Date shall have been duly executed and delivered and be in proper form for filing, and shall create in favor of the Secured Parties, a perfected Lien on, and security interest in, the Collateral, subject to no Liens other than Permitted Liens.

 

(v)           Approvals . Certified copies of all material licenses, consents, authorizations and approvals of, and notices to and filings and registrations with, any Governmental Authority (including all foreign exchange approvals), and of all third-party consents and approvals, necessary in connection with the making and performance by the Obligors of the Loan Documents and the Transactions.

 

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(vi)          Corporate Documents . Certified copies of the constitutive documents of each Obligor (if publicly available in such Obligor’s jurisdiction of formation, certified copies from such public institution), or an officer’s certificate certifying that no changes have been made to such constitutive documents since the Original Closing Date (or in the case of any Obligor incorporated or organized in Germany or Switzerland where up-to-date copies retrieved from the online commercial register shall be sufficient), and of resolutions of the Board of Directors (and/or shareholders, if applicable) of each Obligor authorizing the making and performance by it of the Loan Documents to be entered into on the date hereof and pursuant to Section 8.17 to which it is a party.

 

(vii)         Incumbency Certificate. A certificate (which, for certainty, can be combined with the certificate required pursuant to Section 6.02(g)(v) above) of each Obligor (except for an Obligor incorporated or organized in Germany) as to the authority, incumbency and specimen signatures of the persons who have executed the Loan Documents and any other documents in connection herewith on behalf of the Obligors. In relation to an Obligor incorporated or organized in Germany, (i) a certificate signed by an authorized signatory with the power of representation certifying that each document delivered under clause 6.02(g)(v) above is correct, complete and in full force and effect and has not been amended or superseded as at the date of the certificate and (ii) the specimen signatures of each person authorized to execute any Loan Document.

 

(viii)        Officer’s Certificate . A certificate, dated the Closing Date and signed by the President, a Vice President or a financial officer of Borrower, confirming compliance with the conditions set forth in Section 6.05(b) .

 

(ix)          Opinions of Counsel . Favorable opinions, dated as of the Closing Date, in form acceptable to the Lenders and their counsel, as may include the requests set forth in Exhibit E , provided by:

 

(A)         Blake, Cassels & Graydon LLP, in respect of matters of relating to Canadian law and/or any Obligor organized in Canada or any province or territory thereof;

 

(B)          Skadden, Arps, Slate, Meagher & Flom LLP, in respect of matters relating to United States law and/or any Obligor organized in the United States of America or any state or political subdivision thereof;

 

(C)          Baker & McKenzie LLP, in respect of matters relating to English law and any Obligor organized in England and Wales or any state or political subdivision thereof;

 

(D)          Allen & Overy LLP, in respect of certain matters relating to German law, including corporate matters, relating to any Obligor organized in Germany or any state or political subdivision thereof; and

 

(E)          Eversheds Sutherland, in respect of matters relating to the law of Switzerland and/or any Obligor organized in Switzerland or any state or political subdivision thereof.

 

(x)           Good Standing Certificates . A certificate from the appropriate Governmental Authority, bearing a current date acceptable to the Administrative Agent, to the effect that each Obligor (other than any English Obligor or any Obligor incorporated or organized in Germany or Switzerland) is in good standing and qualified to transact business in its jurisdiction of organization and in each other jurisdiction where it transacts business.

 

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(xi)          Insurance . Certificates of insurance evidencing the existence of all insurance required to be maintained by Borrower pursuant to Section 8.05 and the designation of the Lenders as the lender’s loss payees or additional named insured, as the case may be, thereunder.

 

(xii)         Cipher Transaction . Evidence satisfactory to the Administrative Agent and the Lenders that the Cipher Transaction has been completed.

 

(xiii)        Miscellaneous . All other requirements referred to in Sections I.-VI. of the closing agenda attached hereto as Schedule 6.06 have been satisfied in form and substance satisfactory to the Administrative Agent and the Lenders.

 

SECTION 7

REPRESENTATIONS AND WARRANTIES

 

Each Obligor represents and warrants to Administrative Agent and the Lenders that:

 

7.01       Power and Authority. Each of Borrower and its Subsidiaries (a) is a duly organized and validly existing under the laws of its jurisdiction of organization, (b) has all requisite corporate or other power, and has all material governmental licenses, authorizations, consents and approvals necessary to own its assets and carry on its business as now being or as proposed to be conducted except to the extent that failure to have the same could not reasonably be expected to have a Material Adverse Effect, (c) is qualified to do business and is in good standing in all jurisdictions in which the nature of the business conducted by it makes such qualification necessary and where failure so to qualify could (either individually or in the aggregate) have a Material Adverse Effect, and (d) has full power, authority and legal right to make and perform each of the Loan Documents to which it is a party and, in the case of Borrower, to borrow the Loans hereunder.

 

7.02       Authorization; Enforceability. The Transactions are within each Obligor’s corporate powers and have been duly authorized by all necessary corporate and, if required, by all necessary shareholder action. This Agreement has been duly executed and delivered by each Obligor and constitutes, and each of the other Loan Documents to which it is a party when executed and delivered by such Obligor will constitute, a legal, valid and binding obligation of such Obligor, enforceable against each Obligor in accordance with its terms, except as such enforceability may be limited by (a) bankruptcy, insolvency, reorganization, moratorium or similar laws of general applicability affecting the enforcement of creditors’ rights and (b) the application of general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at law).

 

7.03       Governmental and Other Approvals; No Conflicts. The Transactions (a) do not require any consent or approval of, registration or filing with, or any other action by, any Governmental Authority or any third party, except for (i) such as have been obtained or made and are in full force and effect and (ii) filings and recordings in respect of the Liens created pursuant to the Security Documents, (b) will not violate any applicable law or regulation or the charter, bylaws or other organizational documents of Borrower and its Subsidiaries, (c) will not violate any order of any Governmental Authority, other than any such violations that, individually or in the aggregate, could not reasonably be expected to have a Material Adverse Effect, (d) will not violate or result in a default under any indenture, agreement or other instrument binding upon Borrower and its Subsidiaries or assets, or give rise to a right thereunder to require any payment to be made by any such Person, and (e) will not result in the creation or imposition of any Lien (other than Permitted Liens) on any asset of Borrower and its Subsidiaries.

 

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7.04       Financial Statements; Material Adverse Change.

 

(a)           Financial Statements . Borrower has heretofore furnished to the Lenders certain financial statements as provided for in Section 8.01 . Such financial statements present fairly, in all material respects, the financial position and results of operations and cash flows of Borrower and its Subsidiaries as of such dates and for such periods in accordance with GAAP (provided that any non-Canadian and non-United States organized Subsidiary, “GAAP” for non-consolidated statements may refer to generally accepted accounting principles applicable in the relevant Subsidiary’s jurisdiction), subject to year-end audit adjustments and the absence of footnotes in the case of the previously-delivered statements of the type described in Section 8.01(b) . Neither Borrower nor any of its Subsidiaries has any material contingent liabilities or unusual forward or long-term commitments not disclosed in the aforementioned financial statements.

 

(b)           No Material Adverse Change . Since December 31, 2017, there has been no Material Adverse Change.

 

7.05       Properties.

 

(a)           Property Generally . Each Obligor has good and marketable fee simple title to, or valid leasehold interests in, all its real and personal Property material to its business, subject only to Permitted Liens and except for minor defects in title that do not interfere with its ability to conduct its business as currently conducted or to utilize such properties for their intended purposes.

 

(b)           Intellectual Property . The Obligors represent and warrant to the Lenders as follows, as of the date hereof, each Borrowing Notice Date and each Borrowing Date:

 

(i)            Schedule 7.05(b)(i) (as amended from time to time by Borrower in accordance with Section 8.16 ) contains:

 

(A)          a complete and accurate list of all applied for or registered Patents owned by the Obligors, including the jurisdiction and patent number;

 

(B)          a complete and accurate list of all applied for or registered Trademarks owned by the Obligors, including the jurisdiction, trademark application or registration number and the application or registration date; and

 

(C)          a complete and accurate list of all applied for or registered Copyrights;

 

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(ii)          Each Obligor is the absolute beneficial owner of all right, title and interest in (other than in the case of licensed Intellectual Property, in which case it shall have all rights and interest as licensee) and to and have the right to use the Obligor Intellectual Property with no breaks in chain of title with good and marketable title, free and clear of any Liens or Claims of any kind whatsoever other than Permitted Liens. Without limiting the foregoing, and except as set forth in Schedule 7.05(b)(ii) :

 

(A)         other than with respect to the Material Agreements, or as permitted by Section 9.09 , the Obligors have not transferred ownership of Material Intellectual Property, in whole or in part, to any other Person who is not an Obligor;

 

(B)          other than (i) the Material Agreements, (ii) customary restrictions in in-bound licenses of Intellectual Property and non-disclosure agreements, or (iii) as would have been or is permitted by Section 9.09 , there are no judgments, covenants not to sue, permits, grants, licenses, Liens (other than Permitted Liens), Claims, or other agreements or arrangements relating to Borrower’s Material Intellectual Property, including any development, submission, services, research, license or support agreements, which bind, obligate or otherwise restrict the Obligors;

 

(C)          the use of any of the Obligor Intellectual Property, to any Obligor’s Knowledge, does not breach, violate, infringe or interfere with or constitute a misappropriation of any valid rights arising under any Intellectual Property of any other Person;

 

(D)          to any Obligor’s Knowledge, there are no pending or threatened Claims against the Obligors asserted by any other Person relating to the Obligor Intellectual Property, including any Claims of adverse ownership, invalidity, infringement, misappropriation, violation or other opposition to or conflict with such Intellectual Property; no Obligor has received any written notice from any Person that any Obligor business, the use of the Obligor Intellectual Property, or the manufacture, use or sale of any product or the performance of any service by any Obligor infringes upon, violates or constitutes a misappropriation of, or may infringe upon, violate or constitute a misappropriation of, or otherwise interfere with, any other Intellectual Property of any other Person;

 

(E)          no Obligor has any Knowledge that the Obligor Intellectual Property is being infringed, violated, misappropriated or otherwise used by any other Person without the express authorization of the Obligors. Without limiting the foregoing, no Obligor has put any other Person on notice of actual or potential infringement, violation or misappropriation of any of the Obligor Intellectual Property; no Obligor has initiated the enforcement of any Claim with respect to any of the Obligor Intellectual Property;

 

(F)          all relevant current and former employees and contractors of each Obligor have executed written confidentiality and invention assignment Contracts with such Obligor that irrevocably assign to such Obligor or its designee all of their rights to any Inventions relating to any of Obligor’s business;

 

(G)          to the Knowledge of the Obligors, the Obligor Intellectual Property is all the Intellectual Property necessary for the operation of Obligors’ business as it is currently conducted or as currently contemplated to be conducted;

 

(H)          each Obligor has taken reasonable precautions to protect the secrecy, confidentiality and value of its Obligor Intellectual Property consisting of trade secrets and confidential information;

 

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(I)           each Obligor has delivered to Administrative Agent accurate and complete copies of all Material Agreements relating to the Obligor Intellectual Property;

 

(J)           there are no pending or, to the Knowledge of any of the Obligors, threatened in writing Claims against the Obligors asserted by any other Person relating to the Material Agreements, including any Claims of breach or default under such Material Agreements;

 

(iii)         With respect to the Obligor Intellectual Property consisting of Patents, except as set forth in Schedule 7.05(b)(ii) , and without limiting the representations and warranties in Section 7.05(b)(ii) :

 

(A)         each of the issued claims in such Patents, to Obligors’ Knowledge, is valid and enforceable;

 

(B)          the inventors claimed in such Patents (other than in the case of licensed Patents) have executed written Contracts with an Obligor or its predecessor-in-interest that properly and irrevocably assigns to an Obligor or predecessor-in-interest all of their rights to any of the Inventions claimed in such Patents to the extent permitted by applicable law;

 

(C)          none of the Patents, or the Inventions claimed in them, have been dedicated to the public except as a result of intentional decisions made by the applicable Obligor;

 

(D)          to any Obligor’s Knowledge, all prior art material to such Patents (other than in the case of licensed Patents) was adequately disclosed to or considered by the respective patent offices during prosecution of such Patents to the extent required by applicable law or regulation;

 

(E)          subsequent to the issuance of such Patents, neither any Obligor nor their predecessors in interest, have filed any disclaimer or filed any other voluntary reduction in the scope of the Inventions claimed in such Patents;

 

(F)          no allowable or allowed subject matter of such Patents, to any Obligor’s Knowledge, is subject to any competing conception claims of allowable or allowed subject matter of any patent applications or patents of any third party and have not been the subject of any interference, re-examination or opposition proceedings, nor are the Obligors aware of any basis for any such interference, re-examination or opposition proceedings;

 

(G)          no such Patents, to any Obligor’s Knowledge, have ever been finally adjudicated to be invalid, unpatentable or unenforceable for any reason in any administrative, arbitration, judicial or other proceeding, and, with the exception of publicly available documents in the applicable patent office recorded with respect to any Patents, no Obligor has received any notice asserting that such Patents are invalid, unpatentable or unenforceable; if any of such Patents is terminally disclaimed to another patent or patent application, all patents and patent applications subject to such terminal disclaimer are included in the Collateral;

 

(H)          other than in the case of licensed Patents, Obligor has received an opinion, whether preliminary in nature or qualified in any manner, which concludes that a challenge to the validity or enforceability of any of such Patents is more likely than not to succeed;

 

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(I)           no Obligor has any Knowledge that any Obligor or any prior owner of such Patents (other than in the case of licensed Patents) or their respective agents or representatives have engaged in any conduct, or omitted to perform any necessary act, the result of which would invalidate or render unpatentable or unenforceable any such Patents; and

 

(J)           all maintenance fees, annuities, and the like due or payable on the Patents (other than in the case of licensed Patents in which case all licensing and similar fees) have been timely paid or the failure to so pay was the result of an intentional decision by the applicable Obligor or would not reasonably be expected to result in a Material Adverse Change.

 

(iv)         none of the foregoing representations and statements of fact contains any untrue statement of material fact or omits to state any material fact necessary to make any such statement or representation not misleading to a prospective Lender seeking full information as to the Obligor Intellectual Property and Borrower’s business.

 

(c)           Material Intellectual Property . Schedule 7.05(c) (as amended from time to time by Borrower in accordance with Section 8.16 ) contains an accurate list of the Obligor Intellectual Property that is material to any Obligor’s business with an indication as to whether the applicable Obligor owns or has an exclusive or non-exclusive license to such Obligor Intellectual Property.

 

7.06       No Actions or Proceedings.

 

(a)           Litigation . There is no litigation, investigation or proceeding pending or, to any Obligor’s Knowledge, threatened with respect to Borrower and its Subsidiaries by or before any Governmental Authority or arbitrator (i) that either individually or in the aggregate could reasonably be expected to have a Material Adverse Effect, except as specified in Schedule 7.06 (as amended from time to time by Borrower in accordance with Section 8.16 ) or (ii) that involves this Agreement or the Transactions.

 

(b)           Environmental Matters . The operations and Property of Borrower and its Subsidiaries comply with all applicable Environmental Laws, except to the extent the failure to so comply (either individually or in the aggregate) could not reasonably be expected to have a Material Adverse Effect.

 

(c)           Labor Matters . Borrower has not engaged in unfair labor practices and there are no material labor actions or disputes involving the employees of Borrower.

 

7.07         Compliance with Laws and Agreements. Each of the Obligors is in compliance with all laws, regulations and orders of any Governmental Authority applicable to it or its property and all indentures, agreements and other instruments binding upon it or its property, except where the failure to do so, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect. No Default has occurred and is continuing.

 

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7.08         Taxes. Except as set forth on Schedule 7.08 , each of the Obligors has timely filed or caused to be filed all tax returns and reports required to have been filed and has paid or caused to be paid all Taxes required to have been paid by it, except Taxes that are being contested in good faith by appropriate proceedings and for which such Obligor has set aside on its books adequate reserves with respect thereto in accordance with GAAP (including, in the case of any non-Canadian and non-United States organized Subsidiary Guarantor, in accordance with generally accepted accounting principles applicable in the relevant Subsidiary Guarantor’s jurisdiction). Payments of interest made by the Borrower pursuant to this Agreement are not treated as United States sourced payments for United States federal income tax purposes.

 

7.09       Full Disclosure. Obligors have disclosed to Administrative Agent and the Lenders all Material Agreements to which any Obligor is subject, and all other matters to any Obligor’s Knowledge that, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect. None of the reports, financial statements, certificates or other written information furnished by or on behalf of any Obligor to Administrative Agent or any Lender in connection with the negotiation of this Agreement and the other Loan Documents or delivered hereunder or thereunder (as modified or supplemented by other information so furnished) contains any material misstatement of material fact or omits to state any material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided that , with respect to projected financial information, Borrower represents only that such information was prepared in good faith based upon assumptions believed to be reasonable at the time.

 

7.10       Regulation.

 

(a)           Investment Company Act . Neither Borrower nor any of its Subsidiaries is an “investment company” as defined in, or subject to regulation under, the Investment Company Act of 1940.

 

(b)           Margin Stock . Neither Borrower nor any of its Subsidiaries is engaged principally, or as one of its important activities, in the business of extending credit for the purpose, whether immediate, incidental or ultimate, of buying or carrying Margin Stock, and no part of the proceeds of the Loans will be used to buy or carry any Margin Stock in violation of Regulation T, U or X.

 

7.11       Solvency. Each Obligor is, and immediately after giving effect to the Borrowings and the use of proceeds thereof will be, Solvent; provided that intercompany balances shall be excluded when determining such Solvency.

 

7.12       Subsidiaries. Set forth on Schedule 7.12 is a complete and correct list of all Subsidiaries as of the date hereof. Each such Subsidiary is duly organized and validly existing under the jurisdiction of its organization shown in said Schedule 7.12 , and the percentage ownership by Borrower of each such Subsidiary is as shown in said Schedule 7.12 .

 

7.13       Indebtedness and Liens. Set forth on Schedule 7.13(a) is a complete and correct list of all Indebtedness of each Obligor outstanding as of the date hereof. Schedule 7.13(b) is a complete and correct list of all Liens granted by Borrower and other Obligors with respect to their respective Property and outstanding as of the date hereof.

 

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7.14       Material Agreements. Set forth on Schedule 7.14 (as amended from time to time by Borrower in accordance with Section 8.16 ) is a complete and correct list of (i) each Material Agreement and (ii) each agreement creating or evidencing any Material Indebtedness. No Obligor is in material default under any such Material Agreement or agreement creating or evidencing any Material Indebtedness. Except as otherwise disclosed on Schedule 7.14 , all material vendor purchase agreements and provider contracts of the Obligors are in full force and effect without material modification from the form in which the same were disclosed to Administrative Agent and the Lenders.

 

7.15       Restrictive Agreements. None of the Obligors is subject to any indenture, agreement, instrument or other arrangement that prohibits, restricts or imposes any condition upon (a) the ability of Borrower or any Subsidiary to create, incur or permit to exist any Lien upon any of its property or assets (other than (x) customary provisions in contracts (including without limitation leases and in-bound licenses of Intellectual Property) restricting the assignment thereof and (y) restrictions or conditions imposed by any agreement governing secured Permitted Indebtedness permitted under Section 9.01(h) , to the extent that such restrictions or conditions apply only to the property or assets securing such Indebtedness), or (b) the ability of any Subsidiary to pay dividends or other distributions with respect to any shares of its capital stock or to make or repay loans or advances to Borrower or any other Subsidiary or to Guarantee Indebtedness of Borrower or any other Subsidiary (each, a “ Restrictive Agreement ”), except those listed on Schedule 7.15 or otherwise permitted under Section 9.11 .

 

7.16       Real Property.

 

(a)           Generally . Neither Borrower nor any of its Subsidiaries owns or leases (as tenant thereof) any real property, except as described on Schedule 7.16 (as amended from time to time by Borrower in accordance with Section 8.16 ).

 

(b)          Borrower Lease . (i) Borrower has delivered a true, accurate and complete copy of the Borrower Lease to Administrative Agent.

 

(ii)          The Borrower Lease is in full force and effect and no default has occurred under the Borrower Lease and, to the Knowledge of Borrower, there is no existing condition which, but for the passage of time or the giving of notice, could reasonably be expected to result in a default under the terms of the Borrower Lease.

 

(iii)         Borrower is the tenant under the Borrower Lease and has not transferred, sold, assigned, conveyed, disposed of, mortgaged, pledged, hypothecated, or encumbered any of its interest in, the Borrower Lease.

 

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7.17       Pension Matters. Schedule 7.17 sets forth, as of the date hereof, a complete and correct list of, and that separately identifies, (a) all Title IV Plans, (b) all Multiemployer Plans and (c) all material Benefit Plans. Each Benefit Plan, and each trust thereunder, intended to qualify for tax exempt status under Section 401 or 501 of the Code or other Requirements of Law is the subject of a favorable determination letter from the IRS and no event or condition exists which could reasonably be expected to result in revocation of such qualified status. Except for those that could not, in the aggregate, have a Material Adverse Effect, (x) each Benefit Plan is in compliance with applicable provisions of ERISA, the Code and other Requirements of Law, (y) there are no existing or pending (or to the Knowledge of any Obligor or Subsidiary thereof, threatened) claims (other than routine claims for benefits in the normal course), sanctions, actions, lawsuits or other proceedings or investigation involving any Benefit Plan to which any Obligor or Subsidiary thereof incurs or otherwise has or could have an obligation or any liability or Claim and (z) no ERISA Event is reasonably expected to occur. Borrower and each of its ERISA Affiliates has met all applicable requirements under the ERISA Funding Rules with respect to each Title IV Plan, and no waiver of the minimum funding standards under the ERISA Funding Rules has been applied for or obtained. As of the most recent valuation date for any Title IV Plan, the funding target attainment percentage (as defined in Section 430(d)(2) of the Code) is at least 60%, and neither Borrower nor any of its ERISA Affiliates knows of any facts or circumstances that could reasonably be expected to cause the funding target attainment percentage to fall below 60% as of the most recent valuation date. As of the date hereof, no ERISA Event has occurred in connection with which obligations and liabilities (contingent or otherwise) remain outstanding. No ERISA Affiliate would have any Withdrawal Liability as a result of a complete withdrawal from any Multiemployer Plan on the date this representation is made.

 

7.18       Collateral; Security Interest. Each Security Document is effective to create in favor of the Secured Parties a legal, valid and enforceable security interest in the Collateral subject thereto and each such security interest is perfected to the extent required by (and has the priority required by) the applicable Security Document. The Security Documents collectively are effective to create in favor of the Secured Parties a legal, valid and enforceable security interest in the Collateral, which security interests are, but in relation to German Security Documents only in relation to the German Account Pledge Agreements and the German Share Pledge Agreements, with the ranking in priority which it is expressed to have in the German Account Pledge Agreements and the German Share Pledge Agreements (as the case may be) subject only to Permitted Priority Liens and any pledges granted under the Security Documents entered into in connection with the Original Agreement).

 

7.19       Regulatory Approvals. Borrower and its Subsidiaries hold, and will continue to hold, either directly or through licensees and agents, all Regulatory Approvals, licenses, permits and similar governmental authorizations of a Governmental Authority necessary or required for Borrower and its Subsidiaries to conduct their operations and business in the manner currently conducted.

 

7.20       Canadian Pension or Benefit Plans . No Obligor has at any time in the past or present established or been associated with any Canadian Pension Plans or any Canadian Benefit Plans.

 

7.21       Series A Shares. The Borrower has not as of the date of this Agreement issued any Series A Shares and has not issued or granted any warrants, options or other rights to acquire any Series A Shares.

 

7.22       The Toronto-Dominion Bank Account. The registration filed against the Borrower in the personal property security registry for British Columbia, Canada with base registration # 125132H relates to Indebtedness owing by the Borrower to The Toronto-Dominion Bank that in aggregate does not at any time exceed 50,000 dollars in the lawful currency of Canadian.

 

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SECTION 8

AFFIRMATIVE COVENANTS

 

Each Obligor covenants and agrees with Administrative Agent and the Lenders that, until the Commitments have expired or been terminated and all Obligations have been paid in full indefeasibly in cash:

 

8.01       Financial Statements and Other Information. Borrower will furnish to Administrative Agent:

 

(a)          as soon as available and in any event within 45 days after the end of the first three fiscal quarters of each fiscal year (or 60 days, in the case of the fourth fiscal quarter), the consolidated and consolidating balance sheets of the Obligors as of the end of such quarter, and the related consolidated and consolidating statements of income, shareholders’ equity and cash flows of Borrower and its Subsidiaries for such quarter and the portion of the fiscal year through the end of such quarter, prepared in accordance with GAAP consistently applied, all in reasonable detail and setting forth in comparative form the figures for the corresponding period in the preceding fiscal year, together with a certificate of a Responsible Officer of Borrower stating that such financial statements fairly present the financial condition of Borrower and its Subsidiaries as at such date and the results of operations of Borrower and its Subsidiaries for the period ended on such date and have been prepared in accordance with GAAP consistently applied, subject to changes resulting from normal, year-end audit adjustments and except for the absence of notes;

 

(b)          as soon as available and in any event within 90 days after the end of each fiscal year, the consolidated and consolidating balance sheets of Borrower and its Subsidiaries as of the end of such fiscal year, and the related consolidated and consolidating statements of income, shareholders’ equity and cash flows of Borrower and its Subsidiaries for such fiscal year, prepared in accordance with GAAP consistently applied, all in reasonable detail and setting forth in comparative form the figures for the previous fiscal year, accompanied by a report and opinion thereon of KPMG LLP or another firm of independent certified public accountants of recognized national standing acceptable to the Lenders, which report and opinion shall be prepared in accordance with generally accepted auditing standards and shall not be subject to any qualification or exception as to the scope of such audit, and in the case of such consolidating financial statements, certified by a Responsible Officer of Borrower;

 

(c)          [Intentionally Deleted.]

 

(d)          together with the financial statements required pursuant to Sections 8.01(a) and (b) a compliance certificate of a Responsible Officer as of the end of the applicable accounting period (which delivery may, unless a Lender requests executed originals, be by electronic communication including fax or email and shall be deemed to be an original authentic counterpart thereof for all purposes) in the form of Exhibit D (a “ Compliance Certificate ”) including details of any issues that are material that are raised by auditors;

 

(e)          promptly upon receipt thereof, copies of all letters of representation signed by an Obligor to its auditors and copies of all auditor reports delivered for each fiscal quarter;

 

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(f)          as soon as available, a consolidated financial forecast for Borrower and its Subsidiaries for the following five fiscal years, including forecasted consolidated statements of income and cash flows of Borrower and its Subsidiaries;

 

(g)          [Intentionally Deleted.]

 

(h)          promptly, and in any event within five Business Days after receipt thereof by an Obligor thereof, copies of each notice or other correspondence received from any securities regulator or exchange to the authority of which Borrower may become subject from time to time concerning any investigation or possible investigation or other inquiry by such agency regarding financial or other operational results of such Obligor;

 

(i)           the information regarding insurance maintained by Borrower and its Subsidiaries as required under Section 8.05 ;

 

(j)           promptly following Administrative Agent’s request at any time, proof of Borrower’s compliance with Section 10.01 ; and

 

(k)          within five (5) Business Days of each quarterly board meeting, copies of statements, reports and forecasts presented at such meetings of Borrower’s board of directors which are, in the sole reasonable judgment of Borrower’s CEO and/or CFO, necessary to understand the state of or outlook for the Borrower’s business operations, and which may be redacted. For avoidance of doubt for purposes of compliance with this Section 8.01(k) only, Borrower shall not be required to provide competitively sensitive information, confidential employee information, materials which fall under the attorney-client privilege, or materials provided to committees of the board of directors. In any case, Borrower will provide all information provided to holders of Permitted Cure Debt, provided that any such material may be redacted by Borrower to exclude information relating to the Lenders (including Borrower’s strategy regarding the Loans).

 

8.02         Notices of Material Events. Borrower will furnish to Administrative Agent written notice of the following promptly after a Responsible Officer first learns of the existence of:

 

(a)          the occurrence of any Default;

 

(b)          notice of the occurrence of any event with respect to its property or assets resulting in a Loss aggregating $500,000 (or the Equivalent Amount in other currencies) or more;

 

(c)          (A) any proposed acquisition of stock, assets or property by any Obligor that would reasonably be expected to result in environmental liability under Environmental Laws, and (B)(1) spillage, leakage, discharge, disposal, leaching, migration or release of any Hazardous Material required to be reported to any Governmental Authority under applicable Environmental Laws, and (2) all actions, suits, claims, notices of violation, hearings, investigations or proceedings pending, or to any Obligor’s Knowledge, threatened against or affecting Borrower or any of its Subsidiaries or with respect to the ownership, use, maintenance and operation of their respective businesses, operations or properties, relating to Environmental Laws or Hazardous Material;

 

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(d)          the assertion of any environmental matter by any Person against, or with respect to the activities of, Borrower or any of its Subsidiaries and any alleged violation of or non-compliance with any Environmental Laws or any permits, licenses or authorizations which could reasonably be expected to involve damages in excess of $500,000 other than any environmental matter or alleged violation that, if adversely determined, could not (either individually or in the aggregate) have a Material Adverse Effect;

 

(e)          the filing or commencement of any action, suit or proceeding by or before any arbitrator or Governmental Authority against or affecting Borrower or any of its Affiliates that, if adversely determined, could reasonably be expected to result in a Material Adverse Effect;

 

(f)          (i) on or prior to any filing by any ERISA Affiliate of any notice of intent to terminate any Title IV Plan, a copy of such notice and (ii) promptly, and in any event within ten days, after any Responsible Officer of any ERISA Affiliate knows or has reason to know that a request for a minimum funding waiver under Section 412 of the Code has been filed with respect to any Title IV Plan or Multiemployer Plan, a notice (which may be made by telephone if promptly confirmed in writing) describing such waiver request and any action that any ERISA Affiliate proposes to take with respect thereto, together with a copy of any notice filed with the PBGC or the IRS pertaining thereto;

 

(g)          (i) the termination of any Material Agreement; (ii) the receipt by Borrower or any of its Subsidiaries of any material notice under any Material Agreement; (iii) the entering into of any new Material Agreement by an Obligor; or (iv) any material amendment to a Material Agreement;

 

(h)          the reports and notices as required by the Security Documents;

 

(i)           within 30 days of the date thereof, or, if earlier, on the date of delivery of any financial statements pursuant to Section 8.01 , notice of any material change in accounting policies or financial reporting practices by the Obligors;

 

(j)           promptly after the occurrence thereof, notice of any labor controversy resulting in or threatening to result in any strike, work stoppage, boycott, shutdown or other material labor disruption against or involving an Obligor;

 

(k)          a licensing agreement or arrangement entered into by Borrower or any Subsidiary in connection with any infringement or alleged infringement of the Intellectual Property of another Person;

 

(l)           any other development that results in, or could reasonably be expected to result in, a Material Adverse Effect;

 

(m)         concurrently with the delivery of financial statements under Section 8.01(b) , the creation or other acquisition of any Intellectual Property by Borrower or any Subsidiary after the date hereof and during such prior fiscal year which is registered or becomes registered or the subject of an application for registration with the Canadian Intellectual Property Office, the United States Copyright Office or the United States Patent and Trademark Office, as applicable, or with any other equivalent foreign Governmental Authority;

 

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(n)         any change to any Obligor’s ownership of Deposit Accounts, Securities Accounts and Commodity Accounts, by delivering to Administrative Agent an updated Annex 7 to the Canadian Security Agreement, U.S. Security Agreement or such annex, schedule, exhibit or similar list contained in any other applicable Security Document, in each case setting forth a complete and correct list of all such accounts as of the date of such change; or

 

(o)         such other information respecting the operations, properties, business or condition (financial or otherwise) of the Obligors (including with respect to the Collateral) as Administrative Agent may from time to time reasonably request.

 

Each notice delivered under this Section 8.02 shall be accompanied by a statement of a financial officer or other executive officer of Borrower setting forth the details of the event or development requiring such notice and any action taken or proposed to be taken with respect thereto.

 

8.03       Existence; Conduct of Business. Such Obligor will, and will cause each of its Subsidiaries to, do or cause to be done all things necessary to preserve, renew and keep in full force and effect its legal existence and the rights, licenses, permits, privileges and franchises material to the conduct of its business; provided that the foregoing shall not prohibit any merger, amalgamation, consolidation, liquidation or dissolution permitted under Section 9.03 .

 

8.04       Payment of Taxes and Other Claims. Such Obligor will, and will cause each of its Subsidiaries to, pay and discharge (i) all Taxes, fees, assessments and governmental charges or levies imposed upon it or upon its properties or assets prior to the date on which penalties attach thereto, and all lawful claims for labor, materials and supplies which, if unpaid, might become a Lien upon any properties or assets of Borrower or any Subsidiary, except to the extent such Taxes, fees, assessments or governmental charges or levies, or such claims are being contested in good faith by appropriate proceedings and are adequately reserved against in accordance with GAAP (including, in the case of any non-Canadian and non-United States organized Subsidiary, in accordance with generally accepted accounting principles applicable in the relevant Subsidiary’s jurisdiction); and (ii) all lawful claims which, if unpaid, would by law become a Lien upon its property not constituting a Permitted Lien.

 

8.05       Insurance. Such Obligor will, and will cause each of its Subsidiaries to maintain, with financially sound and reputable insurance companies, insurance in such amounts and against such risks as are customarily maintained by companies engaged in the same or similar businesses operating in the same or similar locations. Upon the request of Administrative Agent or the Majority Lenders, Borrower shall furnish Administrative Agent from time to time with full information as to the insurance carried by it and, if so requested, copies of all such insurance policies. Borrower also shall furnish to Administrative Agent from time to time upon the request of Administrative Agent or the Majority Lenders a certificate from Borrower’s insurance broker or other insurance specialist stating that all premiums then due on the policies relating to insurance on the Collateral have been paid, that such policies are in full force and effect. Borrower shall use commercially reasonable efforts to ensure, or cause others to ensure, that all insurance policies required under this Section 8.05 shall provide that they shall not be terminated or cancelled nor shall any such policy be materially changed in a manner adverse to Borrower without at least 30 days’ prior written notice to Borrower and Administrative Agent. Receipt of notice of termination or cancellation of any such insurance policies or reduction of coverages or amounts thereunder shall entitle the Secured Parties to renew any such policies, cause the coverages and amounts thereof to be maintained at levels required pursuant to the first sentence of this Section 8.05 or otherwise to obtain similar insurance in place of such policies, in each case at the expense of Borrower (payable on demand). The amount of any such expenses shall accrue interest at the Default Rate if not paid on demand, and shall constitute “Obligations”.

 

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8.06       Books and Records; Inspection Rights. Such Obligor will, and will cause each of its Subsidiaries to, keep proper books of record and account in which full, true and correct entries are made of all dealings and transactions in relation to its business and activities. Such Obligor will, and will cause each of its Subsidiaries to, permit any representatives designated by Administrative Agent, upon reasonable prior notice, to visit and inspect its properties, to examine and make extracts from its books and records, and to discuss its affairs, finances and condition with its officers and independent accountants, all at such reasonable times (but not more often than once a year unless an Event of Default has occurred and is continuing) as Administrative Agent may request. The Obligors shall pay all reasonable and documented out-of-pocket costs of all such inspections.

 

8.07       Compliance with Laws and Other Obligations. Such Obligor will, and will cause each of its Subsidiaries to, (i) comply in all material respects with all laws, rules, regulations and orders of any Governmental Authority applicable to it or its property (including Environmental Laws) and (ii) comply in all material respects with all terms of Indebtedness and all other Material Agreements, except where the failure to do so, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect.

 

8.08         Maintenance of Properties, Etc.

 

(a)          Such Obligor shall, and shall cause each of its Subsidiaries to, maintain and preserve all of its properties necessary or useful in the proper conduct of its business in good working order and condition in accordance with the general practice of other Persons of similar character and size, ordinary wear and tear and damage from casualty or condemnation excepted.

 

(b)          Without limiting the generality of Section 8.08(a) , the Borrower shall comply with each of the following covenants with respect to the Borrower Lease:

 

(i)           Borrower shall diligently perform and timely observe all of the terms, covenants and conditions of the Borrower Lease on the part of Borrower to be performed and observed prior to the expiration of any applicable grace period therein provided and do everything necessary to preserve and to keep unimpaired and in full force and effect the Borrower Lease.

 

(ii)          Borrower shall promptly notify Administrative Agent of the giving of any written notice by Borrower Landlord to Borrower of any default by Borrower thereunder, and promptly deliver to Administrative Agent a true copy of each such notice.

 

8.09       Licenses. Such Obligor shall, and shall cause each of its Subsidiaries to, obtain and maintain all licenses, authorizations, consents, filings, exemptions, registrations and other Governmental Approvals necessary in connection with the execution, delivery and performance of the Loan Documents, the consummation of the Transactions or the operation and conduct of its business and ownership of its properties, except where failure to do so could not reasonably be expected to have a Material Adverse Effect.

 

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8.10         Action under Environmental Laws. Such Obligor shall, and shall cause each of its Subsidiaries to, upon becoming aware of the presence of any Hazardous Materials in contravention of applicable Environmental Laws or the existence of any environmental liability under applicable Environmental Laws with respect to their respective businesses, operations or properties, take all actions, at their cost and expense, as shall be necessary or advisable to investigate and clean up the condition of their respective businesses, operations or properties, including all required removal, containment and remedial actions, and restore their respective businesses, operations or properties to a condition in compliance with applicable Environmental Laws.

 

8.11       Use of Proceeds. The proceeds of the Loans will be used only as provided in Section 2.4. No part of the proceeds of the Loans will be used, whether directly or indirectly, for any purpose that entails a violation of Regulations T, U and X.

 

8.12       Certain Obligations Respecting Subsidiaries; Further Assurances.

 

(a)           Subsidiary Guarantors . Each Obligor will take such action, and will cause each of its Subsidiaries to take such action, from time to time as shall be necessary to ensure that, subject to Section 8.12(b) with respect to requirements for Foreign Subsidiaries, all Subsidiaries are “Subsidiary Guarantors” hereunder. Without limiting the generality of the foregoing, in the event that Borrower or any of its Subsidiaries shall form or acquire any new Subsidiary, such Obligor and its Subsidiaries concurrently will, subject to Section 8.12(b) with respect to requirements for Foreign Subsidiaries:

 

(i)           cause such new Subsidiary to become a “Subsidiary Guarantor” hereunder, and a “Grantor” or similar granting party, as applicable, under the Security Documents, pursuant to a Guarantee Assumption Agreement;

 

(ii)          take such action or cause such Subsidiary to take such action (including, if applicable, delivering such shares of stock together with undated transfer powers executed in blank) as shall be necessary to create and perfect valid and enforceable first priority (subject to Permitted Priority Liens) Liens on substantially all of the property of such new Subsidiary as collateral security for the obligations of such new Subsidiary hereunder;

 

(iii)         to the extent that the parent of such Subsidiary is not a party to the Canadian Security Agreement, U.S. Security Agreement or such other Security Document, as applicable, or has not otherwise pledged Equity Interests in its Subsidiaries in accordance with the terms of the Security Documents, as applicable, and this Agreement, cause the parent of such Subsidiary to execute and deliver a pledge agreement in favor of the Secured Parties in respect of all outstanding issued shares of such Subsidiary; and

 

(iv)         deliver such proof of corporate action, incumbency of officers, opinions of counsel and other documents as is consistent with those delivered by each Obligor pursuant to Section 6.01 or as Administrative Agent or the Majority Lenders shall have requested.

 

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(b)           Foreign Subsidiaries.

 

(i)           In the event that, at any time, Foreign Subsidiaries have, in the aggregate, (x) total revenues constituting 5% or more of the total revenues of Borrower and its Subsidiaries on a consolidated basis, or (y) total net assets constituting 5% or more of the total net assets of Borrower and its Subsidiaries on a consolidated basis, promptly (and, in any event, within 30 days after such time) Obligors shall cause one or more of such Foreign Subsidiaries to become Subsidiary Guarantors in the manner set forth in Section 8.12(a) , such that, after such Subsidiaries become Subsidiary Guarantors, the non-guarantor Foreign Subsidiaries in the aggregate shall cease to have revenues or assets, as applicable, that meet the thresholds set forth in clauses (x) and (y) above; provided that no Foreign Subsidiary shall be required to become a Subsidiary Guarantor if doing so would result in material adverse tax consequences for Borrower and its Subsidiaries, taken as a whole;

 

(ii)          In the event that, at any time, any Foreign Subsidiary that is not a Subsidiary Guarantor has cash or deposits on account in excess of $300,000 or the aggregate of such cash or deposits on account for all such Foreign Subsidiaries is in excess of $1,000,000, Borrower shall cause such Foreign Subsidiary(s) to (x) immediately transfer all funds that exceed the amounts identified above to its direct or indirect parent that is a Subsidiary Guarantor or (y) become a Subsidiary Guarantor in the manner set forth in Section 8.12(a) . Notwithstanding the foregoing, this Section 8.12(b)(ii) shall not apply to the Italian Account provided that the balance of assets in the Italian Account does not exceed $2,000,000 (or the equivalent amount in another currency based upon the then current applicable Exchange Rate) or to the Escrow Account provided that the balance of assets in the Escrow Account does not exceed $1,000,000 (or the equivalent amount in another currency based upon the then current applicable Exchange Rate). For certainty, all cash and deposits on accounts of any Foreign Subsidiary that is not a Subsidiary Guarantor which is not required to be transferred in accordance with part (x) above shall not be included in the calculation of Liquidity; and

 

(iii)         In addition to Section 8.12(b)(ii) above, while the Escrow Account exists the Borrower shall, within twenty (20) Business Days after receiving prior written notice from the Administrative Agent (which the Administrative Agent may provide in its sole discretion), cause any Foreign Subsidiary that is not already a Subsidiary Guarantor but which has cash or deposits on account from time to time to become a Subsidiary Guarantor in the manner set forth in Section 8.12(a) , including for certainty providing all necessary security and control agreements, notwithstanding that such Foreign Subsidiary would not otherwise be required to become a Subsidiary Guarantor pursuant to the other terms of this Section 8.12 .

 

(c)           Further Assurances . Such Obligor will, and will cause each of its Subsidiaries to, take such action from time to time as shall reasonably be requested by Administrative Agent or the Majority Lenders to effectuate the purposes and objectives of this Agreement.

 

Without limiting the generality of the foregoing, each Obligor will, and will cause each Person that is required to be a Subsidiary Guarantor to, take such action from time to time (including executing and delivering such assignments, security agreements, control agreements and other instruments) as shall be reasonably requested by Administrative Agent or the Majority Lenders to create, in favor of the Secured Parties, perfected security interests and Liens in substantially all of the property of such Obligor as collateral security for the Obligations; provided that any such security interest or Lien shall be subject to the relevant requirements of the Security Documents.

 

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8.13       Termination of Non-Permitted Liens. In the event that Borrower or any of its Subsidiaries shall become aware or be notified by Administrative Agent or any Lender of the existence of any outstanding Lien against any Property of Borrower or any of its Subsidiaries, which Lien is not a Permitted Lien, Borrower shall use its best efforts to promptly terminate or cause the termination of such Lien.

 

8.14       Intellectual Property. In the event that the Obligors acquire Obligor Intellectual Property during the term of this Agreement, then the provisions of this Agreement shall automatically apply thereto and any such Obligor Intellectual Property shall automatically constitute part of the Collateral under the Security Documents, without further action by any party, in each case from and after the date of such acquisition (except that any representations or warranties of any Obligor shall apply to any such Obligor Intellectual Property only from and after the date, if any, subsequent to such acquisition that such representations and warranties are brought down or made anew as provided herein).

 

8.15       Owned Real Property. In the event that any Obligor acquires any owned real property during the term of this Agreement for consideration in excess of $500,000, such Obligor shall concurrently with such acquisition (i) execute and deliver any mortgage or deed of trust or any other real property security document required by the Administrative Agent to be executed by such Obligor in favor of the Secured Parties, (ii) provide evidence of registration in the appropriate offices of such real property security document with respect to all such real property owned by such Obligor, and (iii) such other real property security documents and instruments as may be required by the Administrative Agent.

 

8.16       Update of Schedules . Each of Schedules 7.05(b)(i) , 7.05(c) , 7.06 , 7.14 and 7.16 shall be updated by Borrower from time to time in order to insure the continued accuracy of such Schedule as of any upcoming date on which representations and warranties are made incorporating the information contained on such Schedule. Such update may be accomplished by Borrower providing to Administrative Agent, in writing (including by electronic means), a revised version of such Schedule in accordance with the provisions of Section 13.02 . Each such updated Schedule shall be effective immediately upon the receipt thereof by the Lenders.

 

8.17       Post-Closing Items . Borrower will deliver, or cause the applicable Subsidiary Guarantor to deliver, the items set forth in Schedule 8.17 on the dates set forth therein. Any post-closing obligation set forth in Schedule 8.17 or the time period applicable to any such post-closing obligation may in each case be waived or extended by the Administrative Agent, from time to time, in its sole discretion.

 

8.18       Swiss Guarantors Each Swiss Guarantor will comply with the Non-Qualifying Bank Creditor Rules; provided that, for this purpose, each Swiss Guarantor shall assume at all times that the number of existing Lenders and Participants hereunder which are not, in each case, Qualifying Bank Creditors shall be ten (10).

 

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8.19       Loan Proceeds. Borrower shall use a portion of the proceeds of the Loans for the benefit of Foreign Subsidiaries that are Subsidiary Guarantors, including the disbursement by the Borrower of a portion of such proceeds to such Subsidiary Guarantors.

 

8.20       Cipher Transaction Proceeds. Upon completion of the Cipher Transaction, Borrower shall immediately deposit all proceeds from the Cipher Transaction into one of its accounts at HSBC Bank Canada.

 

SECTION 9

NEGATIVE COVENANTS

 

Each Obligor covenants and agrees with Administrative Agent and the Lenders that, until the Commitments have expired or been terminated and all Obligations have been paid in full indefeasibly in cash:

 

9.01      Indebtedness. Such Obligor will not, and will not permit any of its Subsidiaries to, create, incur, assume or permit to exist any Indebtedness, whether directly or indirectly, except:

 

(a)          the Obligations;

 

(b)          Indebtedness existing on the date hereof and set forth in Part II of Schedule 7.13(a) and Permitted Refinancings thereof; provided that , in each case, such Indebtedness is subordinated to the Obligations on terms satisfactory to the Majority Lenders;

 

(c)          [Intentionally Deleted.];

 

(d)          accounts payable to trade creditors for goods and services and current operating liabilities (not the result of the borrowing of money) incurred in the ordinary course of Borrower’s or such Subsidiary’s business in accordance with customary terms and paid within the specified time, unless contested in good faith by appropriate proceedings and reserved for in accordance with GAAP;

 

(e)           Indebtedness consisting of guarantees resulting from endorsement of negotiable instruments for collection by any Obligor in the ordinary course of business;

 

(f)           Indebtedness owing by any Obligor to any other Obligor;

 

(g)          Guarantees by any Obligor of Indebtedness of any other Obligor;

 

(h)          normal course of business equipment financing; provided that (i) if secured, the collateral therefor consists solely of the assets being financed, the products and proceeds thereof and books and records related thereto, and (ii) the aggregate outstanding principal amount of such Indebtedness does not exceed $1,000,000 (or the Equivalent Amount in other currencies) at any time;

 

(i)           Permitted Cure Debt;

 

(j)           Permitted Credit Card Indebtedness in an aggregate amount for all Obligors not to exceed $500,000;

 

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(k)          Indebtedness approved in advance in writing by the Majority Lenders; and

 

(l)           Indebtedness arising under any bank guarantee, surety ( Bürgschaft ) or any other instrument issued by a bank or financial institution upon request of an Obligor incorporated in Germany to comply with the requirments of section 8a of the German Act on Partial Retirement ( Altersteilzeitgesetz ) or of section 7e of the German Social Security Code Part IV ( Sozialgesetzbuch IV ).

 

9.02         Liens. Such Obligor will not, and will not permit any of its Subsidiaries to, create, incur, assume or permit to exist any Lien on any property or asset now owned by it, or assign or sell any income or revenues (including accounts receivable) or rights in respect of any thereof, except:

 

(a)          Liens securing the Obligations;

 

(b)          any Lien on any property or asset of Borrower or any of its Subsidiaries existing on the date hereof and set forth in Part II of Schedule 7.13(b) ; provided that (i) no such Lien shall extend to any other property or asset of Borrower or any of its Subsidiaries and (ii) any such Lien shall secure only those obligations which it secures on the date hereof and extensions, renewals and replacements thereof that do not increase the outstanding principal amount thereof;

 

(c)          [Intentionally Deleted.];

 

(d)          Liens securing Indebtedness permitted under Section 9.01(j) ; provided that such Liens do not secure property or assets of the Obligors with an aggregate value in excess of the amount permitted in Section 9.01(j) and the Administrative Agent has received estoppel letters or other agreements, in form and substance satisfactory to the Administrative Agent, in respect of such Liens;

 

(e)          [Intentionally Deleted.]

 

(f)           Liens securing Indebtedness permitted under Section 9.01(h) ; provided that such Liens are restricted solely to the collateral described in Section 9.01(h) ;

 

(g)          Liens imposed by law which were incurred in the ordinary course of business, including (but not limited to) carriers’, warehousemen’s and mechanics’ liens and other similar liens arising in the ordinary course of business and which (x) do not in the aggregate materially detract from the value of the Property subject thereto or materially impair the use thereof in the operations of the business of such Person or (y) are being contested in good faith by appropriate proceedings, which proceedings have the effect of preventing the forfeiture or sale of the Property subject to such liens and for which adequate reserves have been made if required in accordance with GAAP;

 

(h)          pledges or deposits made in the ordinary course of business in connection with workers’ compensation, unemployment insurance or other similar social security legislation;

 

(i)           Liens securing taxes, assessments and other governmental charges, the payment of which is not yet due or is being contested in good faith by appropriate proceedings promptly initiated and diligently conducted and for which such reserve or other appropriate provisions, if any, as shall be required by GAAP shall have been made;

 

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(j)           servitudes, easements, rights of way, restrictions and other similar encumbrances on real Property imposed by applicable Laws and encumbrances consisting of zoning or building restrictions, easements, licenses, restrictions on the use of property or minor imperfections in title thereto which, in the aggregate, are not material, and which do not in any case materially detract from the value of the property subject thereto or interfere with the ordinary conduct of the business of any of the Obligors;

 

(k)          with respect to any real Property, (A) such defects or encroachments as might be revealed by an up-to-date survey of such real Property; (B) the reservations, limitations, provisos and conditions expressed in the original grant, deed or patent of such property by the original owner of such real Property pursuant to applicable Laws; and (C) rights of expropriation, access or user or any similar right conferred or reserved by or in applicable Laws, which, in the aggregate for (A), (B) and (C), are not material, and which do not in any case materially detract from the value of the property subject thereto or interfere with the ordinary conduct of the business of any of the Obligors; and

 

(l)          Bankers liens, rights of setoff and similar Liens incurred on deposits made in the ordinary course of business;

 

(m)          any liens arising under the general terms and conditions of banks and Sparkassen ( Allgemeine Geschäftsbedingungen der Banken und Sparkassen ) or similar general terms and conditions of banks with whom any Obligor maintains a banking relationship in the ordinary course of business;

 

(n)          any landlord’s pledge ( Vermieterpfandrecht ) arising by operation of law under a lease in favour of the relevant third party landlord in Germany; and

 

(o)          any Liens required to be created or subsisting in order to comply with sections 7b and 7e of the German Social Security Code Part IV ( Sozialgesetzbuch IV ), section 8a of the German Partial Retirement Act ( Altersteilzeitgesetz ) and section 4 of the German Act for the Improvement of Occupational Pensions Schemes ( Gesetz zur Verbesserung der betrieblichen Altersvorsorge );

 

provided that no Lien otherwise permitted under any of the foregoing Sections 9.02(b) through (i) shall apply to any Material Intellectual Property.

 

9.03       Fundamental Changes and Acquisitions. Such Obligor will not, and will not permit any of its Subsidiaries to, (i) enter into any transaction of merger, amalgamation or consolidation (ii) liquidate, wind up or dissolve itself (or suffer any liquidation or dissolution), or (iii) make any Acquisition or otherwise acquire any business or substantially all the property from, or capital stock of, or be a party to any acquisition of, any Person, except:

 

(a)          Investments permitted under Section 9.05(e) ;

 

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(b)          the merger, amalgamation or consolidation of any Subsidiary Guarantor with or into any other Obligor from the same country of organization of such Subsidiary Guarantor, provided that the Administrative Agent has confirmed in writing to such Obligors that all applicable Liens granted under the applicable Security Documents will not negatively be affected by such merger, amalgamation or consolidation and that the surviving Obligor shall assume all obligations of the applicable Obligors under the applicable Security Documents;

 

(c)          the sale, lease, transfer or other disposition by any Subsidiary Guarantor of any or all of its property (upon voluntary liquidation or otherwise) to any other Obligor from the same country of organization of such Subsidiary Guarantor;

 

(d)          the sale, transfer or other disposition of the capital stock of any Subsidiary Guarantor to any other Obligor; and

 

(e)          Permitted Acquisitions in an amount not exceeding $5,000,000 in the aggregate during the term of this Agreement.

 

9.04       Lines of Business. Such Obligor will not, and will not permit any of its Subsidiaries to, engage to any material extent in any business other than the business engaged in on the date hereof by Borrower or any Subsidiary or a business reasonably related thereto.

 

9.05       Investments. Such Obligor will not, and will not permit any of its Subsidiaries to, make, directly or indirectly, or permit to remain outstanding any Investments except:

 

(a)          Investments outstanding on the date hereof and identified in Schedule 9.05 ;

 

(b)         operating deposit accounts with banks;

 

(c)          extensions of credit in the nature of accounts receivable or notes receivable arising from the sales of goods or services in the ordinary course of business;

 

(d)         Permitted Cash Equivalent Investments;

 

(e)          Investments by any Obligor in Borrower’s wholly-owned Subsidiary Guarantors (for greater certainty, Borrower shall not be permitted to have any direct or indirect Subsidiaries that are not wholly-owned Subsidiaries);

 

(f)          Hedging Agreements entered into in the ordinary course of Borrower’s financial planning solely to hedge currency risks (and not for speculative purposes);

 

(g)         Investments consisting of security deposits with utilities and other like Persons made in the ordinary course of business;

 

(h)         employee loans, travel advances and guarantees in accordance with Borrower’s usual and customary practices with respect thereto (if permitted by applicable law) which in the aggregate shall not exceed $200,000 outstanding at any time (or the Equivalent Amount in other currencies);

 

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(i)           Investments received in connection with any Insolvency Proceedings in respect of any customers, suppliers or clients and in settlement of delinquent obligations of, and other disputes with, customers, suppliers or clients;

 

(j)           Investments permitted under Section 9.03 ; and

 

(k)          any Investments incurred in relation to any part time worker arrangements in accordance with section 8a of the German Partial Retirement Act ( Altersteilzeitgesetz ) or section 7b and/or 7e of the German Social Security Code Part IV ( Sozialgesetzbuch IV ).

 

9.06       Restricted Payments. Such Obligor will not, and will not permit any of its Subsidiaries to, declare or make, or agree to pay or make, directly or indirectly, any Restricted Payment, except:

 

(a)          Borrower may purchase, redeem, retire, or otherwise acquire shares of its capital stock or other Equity Interests with the proceeds received from a substantially concurrent issue of new shares of its capital stock or other Equity Interests; and

 

(b)          any Subsidiary Guarantor may pay dividends to any other Obligor.

 

9.07       Payments of Indebtedness. Such Obligor will not, and will not permit any of its Subsidiaries to, make any payments in respect of any Indebtedness other than (i) payments of the Obligations, (ii) scheduled payments of other Indebtedness and (iii) repayment of intercompany Indebtedness permitted in reliance upon Section 9.01(f) .

 

9.08       Change in Fiscal Year. Such Obligor will not, and will not permit any of its Subsidiaries to, change the last day of its fiscal year from that in effect on the date hereof, except to change the fiscal year of a Subsidiary acquired in connection with an Acquisition to conform its fiscal year to that of Borrower.

 

9.09       Sales of Assets, Etc. Such Obligor will not, and will not permit any of its Subsidiaries to, sell, lease, exclusively license (in terms of geography or field of use), transfer, or otherwise dispose of any of its Property (including accounts receivable and capital stock of Subsidiaries) to any Person in one transaction or series of transactions (any thereof, an “ Asset Sale ”), except:

 

(a)          transfers of cash in the ordinary course of its business for equivalent value;

 

(b)          sales of inventory in the ordinary course of its business on ordinary business terms;

 

(c)          development and other collaborative arrangements where such arrangements provide for the licenses or disclosure of Patents, Trademarks, Copyrights or other Intellectual Property rights in the ordinary course of business and consistent with general market practices where such license requires periodic payments based on per unit sales of a product over a period of time and provided that such licenses must be true licenses as opposed to licenses that are sales transactions in substance;

 

(d)          transfers of Property by any Subsidiary Guarantor to any other Obligor from the same country of organization of such Subsidiary Guarantor;

 

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(e)          dispositions of any Property that is obsolete or worn out or no longer used or useful in such Obligor’s business;

 

(f)           to comply with the requirements of section 7f of the German Social Security Code Part IV ( Sozialgesetzbuch IV ) or section 4 of the German Act for the Improvement of Occupational Pension Schemes ( Gesetz zur Verbesserung der betrieblichen Altersversorgung );

 

(g)          any transaction permitted under Section 9.03 or 9.05; and

 

(h)          any other Disposition the Net Cash Proceeds of which are applied as required under Section 3.03(b)(i) .

 

9.10       Transactions with Affiliates. Such Obligor will not, and will not permit any of its Subsidiaries to, sell, lease, license or otherwise transfer any assets to, or purchase, lease, license or otherwise acquire any assets from, or otherwise engage in any other transactions with, any of its Affiliates, except:

 

(a)          transactions between or among Obligors;

 

(b)          any transaction permitted under Section 9.01 , 9.05 , 9.06 or 9.09 ;

 

(c)          customary compensation and indemnification of, and other employment arrangements with, directors, officers and employees of Borrower or any Subsidiary in the ordinary course of business,

 

(d)         Borrower may issue Equity Interests to Affiliates in exchange for cash, provided that the terms thereof are no less favorable (including the amount of cash received by Borrower) to Borrower than those that would be obtained in a comparable arm’s-length transaction with a Person not an Affiliate of Borrower; and

 

(e)          the transactions set forth on Schedule 9.10 .

 

9.11       Restrictive Agreements. Such Obligor will not, and will not permit any of its Subsidiaries to, directly or indirectly, enter into, incur or permit to exist any Restrictive Agreement other than (a) restrictions and conditions imposed by law or by this Agreement and (b) Restrictive Agreements listed on Schedule 7.15 .

 

9.12       Amendments to Material Agreements. Such Obligor will not, and will not permit any of its Subsidiaries to, enter into any material amendment to or modification of any Material Agreement or terminate any Material Agreement (unless replaced with another agreement that, viewed as a whole, is on substantially similar or better terms for Borrower or such Subsidiary) without in each case the prior written consent of the Lender (which consent shall not be unreasonably withheld or delayed).

 

9.13       Operating Leases. Borrower will not, and will not permit any of its Subsidiaries to, make any expenditures in respect of operating leases, except for:

 

(a)          real estate operating leases;

 

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(b)          operating leases between Borrower and any of its wholly-owned Subsidiaries or between any of Borrower’s wholly-owned Subsidiaries; and

 

(c)          operating leases that would not cause Borrower and its Subsidiaries, on a consolidated basis, to make payments exceeding $1,000,000 (or the Equivalent Amount in other currencies) in any fiscal year.

 

9.14       Sales and Leasebacks. Except as disclosed on Schedule 9.14 , such Obligor will not, and will not permit any of its Subsidiaries to, become liable, directly or indirectly, with respect to any lease, whether an operating lease or a Capital Lease Obligation, of any property (whether real, personal, or mixed), whether now owned or hereafter acquired, (i) which Borrower or such Subsidiary has sold or transferred or is to sell or transfer to any other Person and (ii) which Borrower or such Subsidiary intends to use for substantially the same purposes as property which has been or is to be sold or transferred.

 

9.15       Hazardous Material. Such Obligor will not, and will not permit any of its Subsidiaries to, use, generate, manufacture, install, treat, release, store or dispose of any Hazardous Material, except in compliance with all applicable Environmental Laws or where the failure to comply could not reasonably be expected to result in a Material Adverse Change.

 

9.16       Accounting Changes. Such Obligor will not, and will not permit any of its Subsidiaries to, make any significant change in accounting treatment or reporting practices, except as required or permitted by GAAP (including, in the case of any non-Canadian and non-United States organized Subsidiary, as permitted by generally accepted accounting principles applicable in the relevant Subsidiary’s jurisdiction).

 

9.17       Compliance with ERISA. No ERISA Affiliate shall cause or suffer to exist (a) any event that could result in the imposition of a Lien with respect to any Title IV Plan or Multiemployer Plan or (b) any other ERISA Event that would, in the aggregate, have a Material Adverse Effect. No Obligor or Subsidiary thereof shall cause or suffer to exist any event that could result in the imposition of a Lien with respect to any Plan.

 

9.18       Canadian Benefit Plans. No Obligor shall, nor shall it permit any of its Subsidiaries to, (a) establish or commence contribution to or otherwise participate in any retirement or pension arrangement that provides defined benefits; (b) acquire an interest in any Person if such Person sponsors, administers, participates in, or has any liability in respect of, any retirement or pension arrangement that provides defined benefits; or (c) establish a Canadian Pension Plan or Canadian Benefit Plan.

 

9.19       [Reserved.]

 

9.20       Series A Shares. Borrower shall not issue any Series A Shares unless prior to any such issuance the Borrower amends its constating documents (including its articles of amalgamation) to remove any right of any holder or beneficiary of any such Series A Shares to receive cash or other payment (other than the issuance of common shares pursuant to a conversion of such Series A Shares) in respect of such Series A Shares.

 

9.21         Swiss Indebtedness . In addition to the covenant in Section 9.01 above, if such Obligor is a Swiss Guarantor, it will not, and will not permit any of its Subsidiaries to, create, incur, assume or permit to exist any Indebtedness, whether directly or indirectly, with any non-Obligor unless such non-Obligor is a Qualifying Bank Creditor.

 

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SECTION 10

FINANCIAL COVENANTS

 

10.01    Minimum Liquidity. The Obligors shall maintain at all times Liquidity (which for certainty shall exclude amounts in the Italian Account and the Escrow Account) in an aggregate amount which shall exceed (i) $5,000,000 from the date hereof to and including December 31, 2018, and (ii) $10,000,000 beginning January 1, 2019 and thereafter.

 

10.02    Minimum Revenue. Borrower and its Subsidiaries shall have annual Revenue from sales of the Product (for each respective calendar year, the “ Minimum Required Revenue ”):

 

(a)          during the twelve month period beginning on January 1, 2016, of at least $24,000,000;

 

(b)          during the twelve month period beginning on January 1, 2017, of at least $24,000,000;

 

(c)          during the twelve month period beginning on January 1, 2018, of at least $27,000,000;

 

(d)          during the twelve month period beginning on January 1, 2019, of at least $36,000,000;

 

(e)          during the twelve month period beginning on January 1, 2020, of at least $60,000,000;

 

(f)          during the twelve month period beginning on January 1, 2021 and all successive twelve month periods thereafter, of at least $75,000,000;

 

(g)          during the twelve month period beginning on January 1, 2022 and all successive twelve month periods thereafter, of at least $85,000,000,

 

or, in each case above, an Equivalent Amount in Canadian dollars if all annual Revenue from sales of the Product is received in Canadian dollars.

 

10.03    Cure Right.

 

(a)          Notwithstanding anything to the contrary contained in Section 11 , in the event that Borrower fails to comply with the covenants contained in Section 10.02(a) through (d) (such covenants for such applicable periods being the “ Specified Financial Covenants ”), Borrower shall have the right within 90 (ninety) days of the end of the respective calendar year:

 

(i)           to issue additional shares of Equity Interests in exchange for cash (the “ Equity Cure Right ”), or

 

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(ii)          to borrow Permitted Cure Debt (the “ Subordinated Debt Cure Right ” and, collectively with the Equity Cure Right, the “ Cure Right ”), in an amount (the “ Cure Amount ”) equal to (x) two (2) multiplied by (y) the difference between the Minimum Required Revenue less Borrower’s annual Revenue. The Cure Amount immediately shall be contributed as equity or subordinated debt (only as permitted pursuant to Section 9.01 ), as applicable, to Borrower, and upon the receipt by Borrower of the Cure Amount pursuant to the exercise of such Cure Right, such Cure Amount shall be deemed to constitute Revenue of Borrower for purposes of the Specified Financial Covenants and the Specified Financial Covenants shall be recalculated for all purposes under the Loan Documents. If, after giving effect to the foregoing recalculation, Borrower shall then be in compliance with the requirements of the Specified Financial Covenants, Borrower shall be deemed to have satisfied the requirements of the Specified Financial Covenants as of the relevant date of determination with the same effect as though there had been no failure to comply therewith at such date, and the applicable breach of the Specified Financial Covenants that had occurred, the related Default and Event of Default, shall be deemed cured without any further action of Borrower or Lenders for all purposes under the Loan Documents.

 

(b)          Notwithstanding anything herein to the contrary the Cure Amount received by Borrower from investors investing in or lending to Borrower pursuant to Section 10.03(a) shall be used to immediately prepay the Loans, without any Prepayment Premium (including for certainty any Backend Facility Fee), credited in the order set forth in Sections 3.03(b)(i)(A)-(F) .

 

SECTION 11

EVENTS OF DEFAULT

 

11.01     Events of Default. Each of the following events shall constitute an “ Event of Default ”:

 

(a)          Borrower shall fail to pay any principal of any Loan when and as the same shall become due and payable, whether at the due date thereof or at a date fixed for prepayment thereof or otherwise;

 

(b)          any Obligor shall fail to pay any Obligation (other than an amount referred to in Section 11.01(a) ) when and as the same shall become due and payable, and such failure shall continue unremedied for a period of three (3) Business Days;

 

(c)          any representation or warranty made or deemed made by or on behalf of Borrower or any of its Subsidiaries in or in connection with this Agreement or any other Loan Document or any amendment or modification hereof or thereof, or in any report, certificate, financial statement or other document furnished pursuant to or in connection with this Agreement or any other Loan Document or any amendment or modification hereof or thereof, shall: (i) prove to have been incorrect when made or deemed made to the extent that such representation or warranty contains any materiality or Material Adverse Effect qualifier; or (ii) prove to have been incorrect in any material respect when made or deemed made to the extent that such representation or warranty does not otherwise contain any materiality or Material Adverse Effect qualifier;

 

(d)          any Obligor shall fail to observe or perform any covenant, condition or agreement contained in Section 8.02 , 8.03 (with respect to Borrower’s existence), 8.11 , 8.12 , 8.14 , 8.17 , 8.18 , 9 or 10 ;

 

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(e)          any Obligor shall fail to observe or perform any covenant, condition or agreement contained in this Agreement (other than those specified in Section 11.01(a) , (b) or (d) ) or any other Loan Document, and, in the case of any failure that is capable of cure, if such failure shall continue unremedied for a period of twenty-five (25) or more days;

 

(f)           Borrower or any of its Subsidiaries shall fail to make any payment (whether of principal or interest and regardless of amount) in respect of any Material Indebtedness, when and as the same shall become due and payable after giving effect to any applicable grace or cure period as originally provided by the terms of such Indebtedness;

 

(g)          (i) any material breach of, or “event of default” or similar event by any Obligor under, any Material Agreement, (ii) any material breach of, or “event of default” or similar event under, the documentation governing any Material Indebtedness shall occur, or (iii) any event or condition occurs (A) that results in any Material Indebtedness becoming due prior to its scheduled maturity or (B) that enables or permits (with or without the giving of notice, the lapse of time or both) the holder or holders of such Material Indebtedness or any trustee or agent on its or their behalf to cause such Material Indebtedness to become due, or to require the prepayment, repurchase, redemption or defeasance thereof, prior to its scheduled maturity; provided that this Section 11.01(g) shall not apply to secured Indebtedness that becomes due as a result of the voluntary sale or transfer of the property or assets securing such Material Indebtedness.

 

(h)          any Obligor:

 

(i)          becomes insolvent, or generally does not or becomes unable to pay its debts or meet its liabilities as the same become due, or admits in writing its inability to pay its debts generally, or declares any general moratorium on its indebtedness, or proposes a compromise or arrangement or deed of company arrangement between it and any class of its creditors;

 

(ii)         commits an act of bankruptcy or makes an assignment of its property for the general benefit of its creditors or makes a proposal (or files a notice of its intention to do so);

 

(iii)        institutes any proceeding seeking to adjudicate it an insolvent, or seeking liquidation, dissolution, winding-up, reorganization, compromise, arrangement, adjustment, protection, moratorium, relief, stay of proceedings of creditors generally (or any class of creditors), or composition of it or its debts or any other relief, under any federal, provincial, territorial or foreign Law now or hereafter in effect relating to bankruptcy, winding-up, insolvency, reorganization, receivership, plans of arrangement or relief or protection of debtors or at common law or in equity, or files an answer admitting the material allegations of a petition filed against it in any such proceeding;

 

(iv)        applies for the appointment of, or the taking of possession by, a receiver, interim receiver, receiver/manager, sequestrator, conservator, custodian, administrator, trustee, liquidator, voluntary administrator, administrative receiver, receiver and manager or other similar official for it or any substantial part of its property; or

 

(v)         takes any action, corporate or otherwise, to approve, effect, consent to or authorize any of the actions described in Section 11.01(h) or (i) , or otherwise acts in furtherance thereof or fails to act in a timely and appropriate manner in defense thereof;

 

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(i)           any petition is filed, application made or other proceeding instituted against or in respect of Borrower or any Subsidiary:

 

(i)           seeking to adjudicate it an insolvent;

 

(ii)          seeking a receiving order against it;

 

(iii)         seeking liquidation, dissolution, winding-up, reorganization, compromise, arrangement, adjustment, protection, moratorium, relief, stay of proceedings of creditors generally (or any class of creditors), deed of company arrangement or composition of it or its debts or any other relief under any federal, provincial, territorial or foreign law now or hereafter in effect relating to bankruptcy, winding-up, insolvency, reorganization, receivership, plans of arrangement or relief or protection of debtors or at common law or in equity; or

 

(iv)         seeking the entry of an order for relief or the appointment of, or the taking of possession by, a receiver, interim receiver, receiver/manager, sequestrator, conservator, custodian, administrator, trustee, liquidator, voluntary administrator, administrative receiver, receiver and manager or other similar official for it or any substantial part of its property, and such petition, application or proceeding continues undismissed, or unstayed and in effect, for a period of thirty (30) days after the institution thereof; provided that if an order, decree or judgment is granted or entered (whether or not entered or subject to appeal) against Borrower or such Subsidiary thereunder in the interim, such grace period will cease to apply; provided further that if Borrower or such Subsidiary files an answer admitting the material allegations of a petition filed against it in any such proceeding, such grace period will cease to apply;

 

(j)           any other event occurs which, under the laws of any applicable jurisdiction, has an effect equivalent to any of the events referred to in either of Section 11.01(h) or (i) (in particular, in relation to an Obligor incorporated or organized in Germany, (x) it is unable to pay its debts as they fall due ( zahlungsunfähig ) within the meaning of section 17 German Insolvency Code ( Insolvenzordnung, InsO ) or over indebted within the meaning of section 19 InsO and/or

 

(y)          the filing for insolvency ( Antrag auf Eröffnung des Insolvenzverfahrens ) for any of the reasons set out in sections 17 or 19 InsO by either the management or a creditor of an Obligor incorporated in Germany or a competent court taking any of the actions set out in section 21 InsO, instituting insolvency proceedings against such Obligor or refusing the opening of insolvency proceedings for insufficiency of assets ( Abweisung mangels Masse ) (within the meaning of section 26 InsO);

 

(k)          one or more judgments for the payment of money in an aggregate amount in excess of $500,000 (or the Equivalent Amount in other currencies) shall be rendered against any Obligor or any combination thereof and the same shall remain undischarged for a period of 45 consecutive days during which execution shall not be effectively stayed, or any action shall be legally taken by a judgment creditor to attach or levy upon any assets of any Obligor to enforce any such judgment;

 

(l)           (i) an ERISA Event shall have occurred that, in the opinion of the Lenders, when taken together with all other ERISA Events that have occurred, could reasonably be expected to result in liability of Borrower and its Subsidiaries in an aggregate amount exceeding (i) $250,000 in any year or (ii) $750,000 for all periods until repayment of all Obligations;

 

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(m)          [Intentionally Deleted.]

 

(n)          a Material Adverse Change shall have occurred;

 

(o)          [Intentionally Deleted];

 

(p)          (i) any Lien created by any of the Security Documents shall at any time not constitute a valid and perfected Lien on the applicable Collateral in favor of the Secured Parties, free and clear of all other Liens (other than Permitted Liens), (ii) except for expiration in accordance with its terms, any of the Security Documents or any Guarantee of any of the Obligations (including that contained in Section 14 ) shall for whatever reason cease to be in full force and effect, or (iii) any of the Security Documents or any Guarantee of any of the Obligations (including that contained in Section 14 ), or the enforceability thereof, shall be repudiated or contested by any Obligor; and

 

(q)          any injunction, whether temporary or permanent, shall be rendered against any Obligor that prevents the Obligors from selling or manufacturing the Product or its commercially available successors, or any of their other material and commercially available products for more than 45 consecutive calendar days in a country or region which accounts for ten percent (10%) or more of the Revenue of Borrower and its Subsidiaries taken as a whole.

 

11.2       Remedies. (a) Upon the occurrence of any Event of Default, then, and in every such event (other than an Event of Default described in Section 11.01(h) , (i) or (j) ), and at any time thereafter during the continuance of such event, the Majority Lenders may, by notice to Borrower, take either or both of the following actions, at the same or different times: (i) terminate the Commitments, and thereupon the Commitments shall terminate immediately, and (ii) declare the Loans then outstanding to be due and payable in whole (or in part, in which case any principal not so declared to be due and payable may thereafter be declared to be due and payable), and thereupon the principal of the Loans so declared to be due and payable, together with accrued interest thereon and all fees and other Obligations, shall become due and payable immediately (in the case of the Loans, at the Redemption Price therefor), without presentment, demand, protest or other notice of any kind, all of which are hereby waived by each Obligor.

 

(b)          Upon the occurrence of any Event of Default described in Section 11.01(h) , (i) or (j) , the Commitments shall automatically terminate and the principal of the Loans then outstanding, together with accrued interest thereon and all fees and other Obligations, shall automatically become due and payable immediately (in the case of the Loans, at the Redemption Price therefor), without presentment, demand, protest or other notice of any kind, all of which are hereby waived by each Obligor.

 

(c)          Upon the occurrence of any Event of Default, the Obligors agree to immediately take any actions requested by the Administrative Agent that the Administrative Agent in its sole discretion determines are required in order to permit the Administrative Agent to enforce the guarantees by the Swiss Guarantors pursuant to Section 14.01 and the Swiss Security Documents in a manner such that no Swiss Withholding Tax will be applicable.

 

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(d)           Prepayment Premium and Redemption Price . (i) For the avoidance of doubt, the Prepayment Premium (as a component of the Redemption Price) shall be due and payable whenever so stated in this Agreement, or by any applicable operation of law, regardless of the circumstances causing any related acceleration or payment prior to the Stated Maturity Date, including without limitation any Event of Default or other failure to comply with the terms of this Agreement, whether or not notice thereof has been given, or any acceleration by, through, or on account of any bankruptcy filing.

 

(ii)          For the avoidance of doubt, the Prepayment Premium (as a component of the Redemption Price) shall be due and payable at any time the Loans become due and payable prior to the Stated Maturity Date for any reason, whether due to acceleration pursuant to the terms of this Agreement (in which case it shall be due immediately, upon the giving of notice to Borrower in accordance with Section 11.02(a) , or automatically, in accordance with Section 11.02(b) ), by operation of law or otherwise (including, without limitation, where bankruptcy filings or the exercise of any bankruptcy right or power, whether in any plan of reorganization or otherwise, results or would result in a payment, discharge, modification or other treatment of the Loans or Loan Documents that would otherwise evade, avoid, or otherwise disappoint the expectations of Lenders in receiving the full benefit of their bargained-for Prepayment Premium or Redemption Price as provided herein). The Obligors and Lenders acknowledge and agree that any Prepayment Premium due and payable in accordance with this Agreement shall not constitute unmatured interest, whether under section 502(b)(3) of the Bankruptcy Code or otherwise, but instead is reasonably calculated to ensure that the Lenders receive the benefit of their bargain under the terms of this Agreement.

 

(iii)         Each Obligor acknowledges and agrees that the Lenders shall be entitled to recover the full amount of the Redemption Price in each and every circumstance such amount is due pursuant to or in connection with this Agreement, including without limitation in the case of any Obligor’s bankruptcy filing, so that the Lenders shall receive the benefit of their bargain hereunder and otherwise receive full recovery as agreed under every possible circumstance, and Borrower hereby waives any defense to payment, whether such defense may be based in public policy, ambiguity, or otherwise. Each Obligor further acknowledges and agrees, and waives any argument to the contrary, that payment of such amount does not constitute a penalty or an otherwise unenforceable or invalid obligation. Any damages that the Lenders may suffer or incur resulting from or arising in connection with any breach by Borrower shall constitute secured obligations owing to the Lenders.

 

SECTION 12

ADMINISTRATIVE AGENT

 

12.01     Appointment and Duties.

 

(a)           Appointment of Administrative Agent . Each Lender hereby appoints CRG Servicing (together with any successor Administrative Agent pursuant to Section 12.09 ) as Administrative Agent hereunder and authorizes Administrative Agent to (i) execute and deliver the Loan Documents and accept delivery thereof on its behalf from any Obligor or any of its Subsidiaries, (ii) take such action on its behalf and to exercise all rights, powers and remedies and perform the duties as are expressly delegated to Administrative Agent under such Loan Documents, (iii) act as agent of such Lender for purposes of acquiring, holding, enforcing and perfecting all Liens granted by the Obligors on the Collateral to secure any of the Obligations and (iv) exercise such powers as are reasonably incidental thereto.

 

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(b)           Italian Appointment. For the purposes of Section 1704 of the Italian Civil Code, each Lender hereby:

 

(i)           appoints CRG Servicing (together with any successor Administrative Agent pursuant to Section 12.09 ) to be its mandatario con rappresentanza and common representative for the purposes of executing in the name and on behalf of the Lenders any Security Document which is expressed to be governed by Italian law;

 

(ii)          grants CRG Servicing (together with any successor Administrative Agent pursuant to Section 12.09 ) the power to negotiate and approve the terms and conditions of such Security Documents, execute any other agreement or instrument, give or receive any notice or declaration, identify and specify to third parties the names of the Lenders at any given date, and take any other action in relation to the creation, perfection, maintenance, enforcement and release of the security created thereunder in the name and on behalf of the Lenders; and

 

(iii)         confirms that, in the event that any security created under the Security Documents expressed to be governed by Italian law remains registered in the name of a Lender after it has ceased to be a Lender, then CRG Servicing (or any successor Administrative Agent pursuant to Section 12.10 ) shall remain empowered to execute a release of such security in its name and on its behalf.

 

(c)           Swiss Appointment. For the purposes of the Security Documents governed by Swiss law, each Lender hereby agrees that the Administrative Agent has entered into or, as applicable, shall enter into, and hold any proceeds or other benefits of any security created under such Security Documents by way of assignment as indirect representative ( indirekter Stellvertreter ), i.e. in its own name but for the account of the Lenders. Furthermore, each present and future Lender shall be deemed, in relation to any security created under such Security Documents (each, a “ Pledge Document ”) by way of pledge, to have authorized the Administrative Agent, in each case in accordance with this Agreement, to (i) accept such pledge as the direct representative ( direkter Stellvertreter ) of such Lender, (ii) hold, administer and, if necessary, enforce such pledge on behalf of such Lender, (iii) agree as the direct representative ( direkter Stellvertreter ) of such Lender to any variation of or waiver of any right under such Pledge Document, (iv) effect as the direct representative (direkter Stellvertreter) of such Lender any release of such pledge, and (v) exercise as the direct representative (direkter Stellvertreter) of such Lender such other rights granted to the Administrative Agent under or in respect of such pledge.

 

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12.02     Duties as Collateral and Disbursing Agent. Without limiting the generality of Section 12.01(a) , Administrative Agent shall have the sole and exclusive right and authority (to the exclusion of the Lenders), and is hereby authorized, to (i) act as the disbursing and collecting agent for the Lenders with respect to all payments and collections arising in connection with the Loan Documents (including in any proceeding described in Section 11.01(h) , (i) or (j) or any other bankruptcy, insolvency or similar proceeding), and each Person making any payment in connection with any Loan Document to any Secured Party is hereby authorized to make such payment to Administrative Agent, (ii) file and prove claims and file other documents necessary or desirable to allow the claims of the Secured Parties with respect to any Obligation in any proceeding described in Section 11.01(h) , (i) or (j) or any other bankruptcy, insolvency or similar proceeding (but not to vote, consent or otherwise act on behalf of such Secured Party), (iii) act as collateral agent for each Secured Party for purposes of acquiring, holding, enforcing and perfecting all Liens created by the Loan Documents and all other purposes stated therein, (iv) manage, supervise and otherwise deal with the Collateral, (v) take such other action as is necessary or desirable to maintain the perfection and priority of the Liens created or purported to be created by the Loan Documents, (vi) except as may be otherwise specified in any Loan Document, exercise all remedies given to Administrative Agent and the other Secured Parties with respect to the Collateral, whether under the Loan Documents, applicable Requirements of Law or otherwise, (vii) enter into subordination agreements with respect to Permitted Cure Debt or any other subordination agreement or intercreditor agreement with respect to Indebtedness of an Obligor and (viii) execute any amendment, consent or waiver under the Loan Documents on behalf of any Lender that has consented in writing to such amendment, consent or waiver; provided, however, that Administrative Agent hereby appoints, authorizes and directs each Lender to act as collateral sub-agent for Administrative Agent and the Secured Parties for purposes of the perfection of all Liens with respect to the Collateral, including any deposit account maintained by a Obligor with, and cash and Permitted Cash Equivalent Investments held by, such Lender, and may further authorize and direct any Lender to take further actions as collateral sub-agents for purposes of enforcing such Liens or otherwise to transfer the Collateral subject thereto to Administrative Agent, and each Lender hereby agrees to take such further actions to the extent, and only to the extent, so authorized and directed.

 

(a)           Limited Duties . Under the Loan Documents, Administrative Agent (i) is acting solely on behalf of the Lenders (except to the limited extent provided in Section 12.07 ), with duties that are entirely administrative in nature, notwithstanding the use of the defined term “Administrative Agent”, the terms “agent”, “administrative agent” and “collateral agent” and similar terms in any Loan Document to refer to Administrative Agent, which terms are used for title purposes only, (ii) is not assuming any obligation under any Loan Document other than as expressly set forth therein or any role as agent, fiduciary or trustee of or for any Lender or any other Secured Party and (iii) shall have no implied functions, responsibilities, duties, obligations or other liabilities under any Loan Document, and each Lender hereby waives and agrees not to assert any claim against Administrative Agent based on the roles, duties and legal relationships expressly disclaimed in the foregoing clauses (i) through (iii) .

 

12.03    Binding Effect. Each Lender agrees that (i) any action taken by Administrative Agent or the Majority Lenders (or, if expressly required hereby, a greater proportion of the Lenders) in accordance with the provisions of the Loan Documents, (ii) any action taken by Administrative Agent in reliance upon the instructions of the Majority Lenders (or, where so required, such greater proportion) and (iii) the exercise by Administrative Agent or the Majority Lenders (or, where so required, such greater proportion) of the powers set forth herein or therein, together with such other powers as are reasonably incidental thereto, shall be authorized and binding upon all of the Secured Parties.

 

12.04    Use of Discretion. (a) No Action without Instructions . Administrative Agent shall not be required to exercise any discretion or take, or to omit to take, any action, including with respect to enforcement or collection, except any action it is required to take or omit to take (i) under any Loan Document or (ii) pursuant to instructions from the Majority Lenders (or, where expressly required by the terms of this Agreement, a greater proportion of the Lenders).

 

(b)           Right Not to Follow Certain Instructions . Notwithstanding Section 12.04(a) , Administrative Agent shall not be required to take, or to omit to take, any action (i) unless, upon demand, Administrative Agent receives an indemnification satisfactory to it from the Lenders (or, to the extent applicable and acceptable to Administrative Agent, any other Secured Party) against all liabilities that, by reason of such action or omission, may be imposed on, incurred by or asserted against Administrative Agent or any Related Person thereof or (ii) that is, in the opinion of Administrative Agent or its counsel, contrary to any Loan Document or applicable Requirement of Law.

 

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12.05     Delegation of Rights and Duties. Administrative Agent may, upon any term or condition it specifies, delegate or exercise any of its rights, powers and remedies under, and delegate or perform any of its duties or any other action with respect to, any Loan Document by or through or to any trustee, co-agent, sub-agent, employee, attorney-in-fact and any other Person (including any other Secured Party). Any such Person shall benefit from this Section 12 to the extent provided by Administrative Agent. Administrative Agent shall not be responsible for the negligence or misconduct of any sub-agent except to the extent that a court of competent jurisdiction determines in a final and nonappealable judgment that Administrative Agent acted with gross negligence or willful misconduct in the selection of such sub-agent.

 

12.06     Reliance and Liability. (a) Administrative Agent may, without incurring any liability hereunder, (i) consult with any of its Related Persons and, whether or not selected by it, any other advisors, accountants and other experts (including advisors to, and accountants and experts engaged by, any Obligor) and (ii) rely and act upon any document and information and any telephone message or conversation, in each case believed by it to be genuine and transmitted, signed or otherwise authenticated by the appropriate parties.

 

(b)          None of Administrative Agent and its Related Persons shall be liable for any action taken or omitted to be taken by any of them under or in connection with any Loan Document, and each Lender and each Obligor hereby waives and shall not assert any right, claim or cause of action based thereon, except to the extent of liabilities resulting primarily from the gross negligence or willful misconduct of Administrative Agent or, as the case may be, such Related Person (each as determined in a final, non-appealable judgment by a court of competent jurisdiction) in connection with the duties expressly set forth herein. Without limiting the foregoing, Administrative Agent:

 

(i)          shall not be responsible or otherwise incur liability for any action or omission taken in reliance upon the instructions of the Majority Lenders or for the actions or omissions of any of its Related Persons selected with reasonable care (other than employees, officers and directors of Administrative Agent, when acting on behalf of Administrative Agent);

 

(ii)         shall not be responsible to any Secured Party for the due execution, legality, validity, enforceability, effectiveness, genuineness, sufficiency or value of, or the attachment, perfection or priority of any Lien created or purported to be created under or in connection with, any Loan Document;

 

(iii)        makes no warranty or representation, and shall not be responsible, to any Secured Party for any statement, document, information, representation or warranty made or furnished by or on behalf of any Related Person, in or in connection with any Loan Document or any transaction contemplated therein, whether or not transmitted by Administrative Agent, including as to completeness, accuracy, scope or adequacy thereof, or for the scope, nature or results of any due diligence performed by Administrative Agent in connection with the Loan Documents; and

 

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(iv)        shall not have any duty to ascertain or to inquire as to the performance or observance of any provision of any Loan Document, whether any condition set forth in any Loan Document is satisfied or waived, as to the financial condition of any Obligor or as to the existence or continuation or possible occurrence or continuation of any Default or Event of Default and shall not be deemed to have notice or knowledge of such occurrence or continuation unless it has received a notice from Borrower, any Lender describing such Default or Event of Default clearly labeled “notice of default” (in which case Administrative Agent shall promptly give notice of such receipt to all Lenders);

 

and, for each of the items set forth in clauses (i) through (iv) above, each Lender and each Obligor hereby waives and agrees not to assert any right, claim or cause of action it might have against Administrative Agent based thereon.

 

12.07     Administrative Agent Individually. Administrative Agent and its Affiliates may make loans and other extensions of credit to, acquire Equity Interests of, engage in any kind of business with, any Obligor or Affiliate thereof as though it were not acting Administrative Agent and may receive separate fees and other payments therefor. To the extent Administrative Agent or any of its Affiliates makes any Loan or otherwise becomes a Lender hereunder, it shall have and may exercise the same rights and powers hereunder and shall be subject to the same obligations and liabilities as any other Lender and the terms “Lender”, “Majority Lender”, and any similar terms shall, except where otherwise expressly provided in any Loan Document, include, without limitation, Administrative Agent or such Affiliate, as the case may be, in its individual capacity as Lender or as one of the Majority Lenders, respectively.

 

12.08    Lender Credit Decision. Each Lender acknowledges that it shall, independently and without reliance upon Administrative Agent, any Lender or any of their Related Persons or upon any document solely or in part because such document was transmitted by Administrative Agent or any of its Related Persons, conduct its own independent investigation of the financial condition and affairs of each Obligor and make and continue to make its own credit decisions in connection with entering into, and taking or not taking any action under, any Loan Document or with respect to any transaction contemplated in any Loan Document, in each case based on such documents and information as it shall deem appropriate.

 

12.09     Expenses; Indemnities. (a) Each Lender agrees to reimburse Administrative Agent and each of its Related Persons (to the extent not reimbursed by any Obligor) promptly upon demand for such Lender’s Proportionate Share of any costs and expenses (including fees, charges and disbursements of financial, legal and other advisors and Other Taxes paid in the name of, or on behalf of, any Obligor) that may be incurred by Administrative Agent or any of its Related Persons in connection with the preparation, syndication, execution, delivery, administration, modification, consent, waiver or enforcement (whether through negotiations, through any work- out, bankruptcy, restructuring or other legal or other proceeding or otherwise) of, or legal advice in respect of its rights or responsibilities under, any Loan Document.

 

(b)          Each Lender further agrees to indemnify Administrative Agent and each of its Related Persons (to the extent not reimbursed by any Obligor), from and against such Lender’s aggregate Proportionate Share of the liabilities (including taxes, interests and penalties imposed for not properly withholding or backup withholding on payments made to on or for the account of any Lender) that may be imposed on, incurred by or asserted against Administrative Agent or any of its Related Persons in any matter relating to or arising out of, in connection with or as a result of any Loan Document, any related document or any other act, event or transaction related, contemplated in or attendant to any such document, or, in each case, any action taken or omitted to be taken by Administrative Agent or any of its Related Persons under or with respect to any of the foregoing; provided, however, that no Lender shall be liable to Administrative Agent or any of its Related Persons to the extent such liability is found in a final, non-appealable judgment by a court of competent jurisdiction to have resulted from such Administrative Agent’s or such Related Person’s gross negligence or willful misconduct.

 

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12.10     Resignation of Administrative Agent. (a) Administrative Agent may resign at any time by delivering notice of such resignation to the Lenders and Borrower, effective on the date set forth in such notice or, if not such date is set forth therein, upon the date such notice shall be effective. If Administrative Agent delivers any such notice, the Majority Lenders shall have the right to appoint a successor Administrative Agent. If, within thirty (30) days after the retiring Administrative Agent having given notice of resignation, no successor Administrative Agent has been appointed by the Majority Lenders that has accepted such appointment, then the retiring Administrative Agent may, on behalf of the Lenders, appoint a successor Administrative Agent from among the Lenders. Each appointment under this Section 12.10(a) shall be subject to the prior consent of Borrower, which may not be unreasonably withheld but shall not be required during the continuance of an Event of Default.

 

(b)          Effective immediately upon its resignation, (i) the retiring Administrative Agent shall be discharged from its duties and obligations under the Loan Documents, (ii) the Lenders shall assume and perform all of the duties of Administrative Agent until a successor Administrative Agent shall have accepted a valid appointment hereunder, (iii) the retiring Administrative Agent and its Related Persons shall no longer have the benefit of any provision of any Loan Document other than with respect to any actions taken or omitted to be taken while such retiring Administrative Agent was, or because such Administrative Agent had been, validly acting as Administrative Agent under the Loan Documents and (iv) subject to its rights under Section 12.03 , the retiring Administrative Agent shall take such action as may be reasonably necessary to assign to the successor Administrative Agent its rights as Administrative Agent under the Loan Documents. Effective immediately upon its acceptance of a valid appointment as Administrative Agent, a successor Administrative Agent shall succeed to, and become vested with, all the rights, powers, privileges and duties of the retiring Administrative Agent under the Loan Documents.

 

12.11     Release of Collateral or Guarantors. Each Lender hereby consents to the release and hereby directs Administrative Agent to release (or, in the case of Section 12.11(b)(ii) , release or subordinate) the following:

 

(a)          any Subsidiary of Borrower from its guaranty of any Obligation of any Obligor if all of the Equity Interests in such Subsidiary owned by any Obligor or any of its Subsidiaries are disposed of in an Asset Sale permitted under the Loan Documents (including pursuant to a waiver or consent), to the extent that, after giving effect to such Asset Sale, such Subsidiary would not be required to guaranty any Obligations pursuant to Section 8.12 ; and

 

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(b)          any Lien held by Administrative Agent for the benefit of the Secured Parties against (i) any Collateral that is disposed of by an Obligor in an Asset Sale permitted by the Loan Documents (including pursuant to a valid waiver or consent), to the extent all Liens required to be granted in such Collateral pursuant to Section 8.12 after giving effect to such Asset Sale have been granted, (ii) any property subject to a Lien described in Section 9.02(f) and (iii) all of the Collateral and all Obligors, upon (A) termination of the Commitments, (B) payment and satisfaction in full of all Loans and all other Obligations that Administrative Agent has been notified in writing are then due and payable, (C) deposit of cash collateral with respect to all contingent Obligations, in amounts and on terms and conditions and with parties satisfactory to the Majority Lenders and each indemnitee that is owed such Obligations and (D) to the extent requested by Administrative Agent, receipt by the Secured Parties of liability releases from the Obligors each in form and substance acceptable to Administrative Agent.

 

Each Lender hereby directs Administrative Agent, and Administrative Agent hereby agrees, upon receipt of reasonable advance notice from Borrower, to execute and deliver or file such documents and to perform other actions reasonably necessary to release the guaranties and Liens when and as directed in this Section 12.11 .

 

12.12     Additional Secured Parties. The benefit of the provisions of the Loan Documents directly relating to the Collateral or any Lien granted thereunder shall extend to and be available to any Secured Party that is not a Lender as long as, by accepting such benefits, such Secured Party agrees, as among Administrative Agent and all other Secured Parties, that such Secured Party is bound by (and, if requested by Administrative Agent, shall confirm such agreement in a writing in form and substance acceptable to Administrative Agent) this Section 12 and the decisions and actions of Administrative Agent and the Majority Lenders (or, where expressly required by the terms of this Agreement, a greater proportion of the Lenders) to the same extent a Lender is bound; provided, however, that, notwithstanding the foregoing, (a) such Secured Party shall be bound by Section 12.09 only to the extent of liabilities, costs and expenses with respect to or otherwise relating to the Collateral held for the benefit of such Secured Party, in which case the obligations of such Secured Party thereunder shall not be limited by any concept of Proportionate Share or similar concept, (b) each of Administrative Agent and each Lender shall be entitled to act at its sole discretion, without regard to the interest of such Secured Party, regardless of whether any Obligation to such Secured Party thereafter remains outstanding, is deprived of the benefit of the Collateral, becomes unsecured or is otherwise affected or put in jeopardy thereby, and without any duty or liability to such Secured Party or any such Obligation and (c) such Secured Party shall not have any right to be notified of, consent to, direct, require or be heard with respect to, any action taken or omitted in respect of the Collateral or under any Loan Document.

 

12.13     Quebec Security. For the purposes of the grant of security under the laws of the Province of Quebec which may now or in the future be required to be provided by the Borrower or any other Obligor, the Administrative Agent is hereby irrevocably authorized and appointed to act as the hypothecary representative (within the meaning of Article 2692 of the Civil Code of Québec) on behalf of all Secured Parties in order to hold any hypothec granted under the laws of the Province of Quebec pursuant to any deed of hypothec as security for the Obligations and to exercise such rights and duties as are conferred upon a hypothecary representative under the relevant deed of hypothec and applicable laws (with the power to delegate any such rights or duties). The execution prior to the date hereof by the Administrative Agent of any deed of hypothec made pursuant to the laws of the Province of Quebec, is hereby ratified and confirmed. For greater certainty, the Administrative Agent, acting as hypothecary representative, shall have the same rights, powers, immunities, indemnities and exclusions from liability as are prescribed in favour of the Administrative Agent, which shall apply mutatis mutandis . In the event of the resignation and appointment of a successor Administrative Agent, such successor Administrative Agent shall automatically (and without any further action) become the successor hypothecary representative on behalf of all Secured Parties. Notwithstanding Section 17 , this provision shall be governed and construed in accordance with the laws of the Province of Quebec.

 

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12.14     French Security.

 

(a)          Without prejudice to the generality of Section 12.01 above and only to the extent necessary, each Secured Party (i) appoints the Administrative Agent to act as agent ( mandataire ) pursuant to Article 1984 of the French Civil Code ( Code civil ) for the purpose of executing any Security Documents expressed to be or construed to be governed by French law (together, the “ French Security Documents ”) in its name, (ii) confirms its approval of the French Security Documents creating or expressed to create a security interest benefiting to it and any security interest created or to be created pursuant thereto and, (iii) irrevocably authorises, empowers and directs the Administrative Agent (by itself or by such person(s) as it may nominate) on its behalf, to perform the duties and to exercise the rights, powers and discretions that are specifically delegated to it under or in connection with the French Security Documents, to take any action and exercise any right, power, authorities and discretion upon the terms and conditions set out in this Agreement under or in connection with the French Security Documents, in each case together with any other rights, powers and discretions which are incidental thereto, to give a good discharge for any moneys payable under the French Security Documents and to release any security interest created under the French Security Documents, it being understood that each Secured Party (other than the Administrative Agent) shall issue special powers of attorneys in all cases where the exercise of powers granted under this Agreement requires the issuance of any such special powers of attorney, and the Administrative Agent accepts such appointment.

 

(b)          It is expressly agreed amongst the parties to this Agreement that the security interest created pursuant to the Security Documents subject to French law shall be reserved ( réservés ) for the benefit of any new Lenders or new Secured Parties in accordance with the terms of article 1278 of the French Civil Code ( Code civil ) in case of any novation, assignment or transfer under Section 13 . For the purposes of articles 1278 et seq. of the French Civil Code ( Code civil ), each existing Lender expressly reserves such security interest to the benefit of each new Lender and the obligations of each Obligor under the above mentioned security interest under the French law governed Security Documents will continue in full force and effect for the benefit of the new Lenders following any novation, assignment or transfer under Section 13 , which is expressly agreed and confirmed by the existing Lenders and the relevant Obligors and all other parties from time to time to this Agreement.

 

SECTION 13

MISCELLANEOUS

 

13.01     No Waiver. No failure on the part of Administrative Agent or any Lender to exercise and no delay in exercising, and no course of dealing with respect to, any right, power or privilege under any Loan Document shall operate as a waiver thereof, nor shall any single or partial exercise of any right, power or privilege under any Loan Document preclude any other or further exercise thereof or the exercise of any other right, power or privilege. The remedies provided herein are cumulative and not exclusive of any remedies provided by law.

 

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13.02     Notices. All notices, requests, instructions, directions and other communications provided for herein (including any modifications of, or waivers, requests or consents under, this Agreement) shall be given or made in writing (including by telecopy) delivered, if to Borrower, another Obligor, Administrative Agent or any Lender, to its address specified on the signature pages hereto or its Guarantee Assumption Agreement, as the case may be, or at such other address as shall be designated by such party in a notice to the other parties. Except as otherwise provided in this Agreement, all such communications shall be deemed to have been duly given upon receipt of a legible copy thereof, in each case given or addressed as aforesaid. All such communications provided for herein by telecopy shall be confirmed in writing promptly after the delivery of such communication (it being understood that non-receipt of written confirmation of such communication shall not invalidate such communication).

 

13.03     Expenses, Indemnification, Etc.

 

(a)           Expenses . Borrower agrees to pay or reimburse (i) Administrative Agent and the Lenders for all of their reasonable out of pocket costs and expenses (including the reasonable fees and expenses of Osler, Hoskin & Harcourt LLP, Baker & McKenzie LLP and Foley Hoag LLP, each as special counsel to Administrative Agent and the Lenders, and any sales, goods and services or other similar taxes applicable thereto, and printing, reproduction, document delivery, communication and travel costs) in connection with (x) the negotiation, preparation, execution and delivery of this Agreement and the other Loan Documents and the making of the Loans (exclusive of post-closing costs) and the consideration and review of the Cipher Transaction, (y) post-closing costs including, without limitation, post-closing costs arising as a direct or indirect result of the Cipher Transaction and (z) the negotiation or preparation of any modification, supplement or waiver of any of the terms of this Agreement or any of the other Loan Documents (whether or not consummated) and (ii) Administrative Agent and the Lenders for all of their out of pocket costs and expenses (including the fees and expenses of legal counsel) in connection with any enforcement or collection proceedings resulting from the occurrence of an Event of Default.

 

(b)           Indemnification . Borrower hereby indemnifies Administrative Agent, each Lender, their respective Affiliates, and their respective directors, officers, employees, attorneys, agents, advisors and controlling parties (each, an “ Indemnified Party ”) from and against, and agrees to hold them harmless against, any and all Claims and Losses of any kind (including reasonable fees and disbursements of counsel), joint or several, that may be incurred by or asserted or awarded against any Indemnified Party, in each case arising out of or in connection with or relating to any investigation, litigation or proceeding or the preparation of any defense with respect thereto arising out of or in connection with or relating to this Agreement or any of the other Loan Documents or the transactions contemplated hereby or thereby or any use made or proposed to be made with the proceeds of the Loans, whether or not such investigation, litigation or proceeding is brought by Borrower, any of its shareholders or creditors, an Indemnified Party or any other Person, or an Indemnified Party is otherwise a party thereto, and whether or not any of the conditions precedent set forth in Section 6 are satisfied or the other transactions contemplated by this Agreement are consummated, except to the extent such Claim or Loss is found in a final, non-appealable judgment by a court of competent jurisdiction to have resulted from such Indemnified Party’s gross negligence or willful misconduct. No Obligor shall assert any claim against any Indemnified Party, on any theory of liability, for consequential, indirect, special or punitive damages arising out of or otherwise relating to this Agreement or any of the other Loan Documents or any of the transactions contemplated hereby or thereby or the actual or proposed use of the proceeds of the Loans. Borrower, its Subsidiaries and Affiliates and their respective directors, officers, employees, attorneys, agents, advisors and controlling parties are each sometimes referred to in this Agreement as a “ Borrower Party .” No Lender shall assert any claim against any Borrower Party, on any theory of liability, for consequential, indirect, special or punitive damages arising out of or otherwise relating to this Agreement or any of the other Loan Documents or any of the transactions contemplated hereby or thereby or the actual or proposed use of the proceeds of the Loans.

 

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13.04     Amendments, Etc. Except as otherwise expressly provided in this Agreement, any provision of this Agreement may be modified or supplemented only by an instrument in writing signed by Borrower and the Majority Lenders (or Administrative Agent on behalf of such the Majority Lenders); provided however, that :

 

(a)          the consent of all of the Lenders shall be required to:

 

(i)           amend, modify, discharge, terminate or waive any of the terms of this Agreement if such amendment, modification, discharge, termination or waiver would increase the amount of the Loans, reduce the fees payable hereunder, reduce interest rates or other amounts payable with respect to the Loans, extend any date fixed for payment of principal, interest or other amounts payable relating to the Loans or extend the repayment dates of the Loans;

 

(ii)         amend the provisions of Section 6 ;

 

(iii)        amend, modify, discharge, terminate or waive any Security Document if the effect is to release a material part of the Collateral subject thereto other than pursuant to the terms hereof or thereof; or

 

(iv)        amend this Section 13.04 ; and

 

(b)          no amendment, waiver or consent shall affect the rights or duties under any Loan Document of, or any payment to, Administrative Agent (or otherwise modify any provision of Section 12 or the application thereof) unless in writing and signed by Administrative Agent in addition to any signature otherwise required.

 

Notwithstanding anything to the contrary herein, a Defaulting Lender shall not have any right to approve or disapprove any amendment, waiver or consent hereunder (and any amendment, waiver or consent which by its terms requires the consent of all Lenders or each affected Lender may be effected with the consent of the applicable Lenders other than Defaulting Lenders), except that (x) the Commitment of any Defaulting Lender may not be increased or extended without the consent of such Lender and (y) any waiver, amendment or modification requiring the consent of all Lenders or each affected Lender that by its terms affects any Defaulting Lender more adversely than other affected Lenders shall require the consent of such Defaulting Lender.

 

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13.05     Successors and Assigns.

 

(a)           General . The provisions of this Agreement and the other Loan Documents shall be binding upon and inure to the benefit of the parties hereto and their respective successors and assigns permitted hereby, except that Borrower may not assign or otherwise transfer any of its rights or obligations hereunder or under any of the other Loan Documents without the prior written consent of the Lenders. Any of the Lenders may assign or otherwise transfer any of their rights or obligations hereunder or under any of the other Loan Documents to an assignee in accordance with the provisions of Section 13.05(b) , (ii) by way of participation in accordance with the provisions of Section 13.05(e) or (iii) by way of pledge or assignment of a security interest subject to the restrictions of Section 13.05(g) . Nothing in this Agreement, expressed or implied, shall be construed to confer upon any Person (other than the parties hereto, their respective successors and assigns permitted hereby, Participants to the extent provided in Section 13.05(e) and, to the extent expressly contemplated hereby, the Indemnified Parties) any legal or equitable right, remedy or claim under or by reason of this Agreement.

 

(b)           Assignments by Lenders . Any of the Lenders may at any time assign to one or more Eligible Transferees (or, if an Event of Default has occurred and is continuing, to any Person) all or a portion of their rights and obligations under this Agreement (including all or a portion of the Commitment and the Loans at the time owing to it); provided, however, that no such assignment shall be made to Borrower, an Affiliate of Borrower, or any employees or directors of Borrower at any time. Subject to the recording thereof by Administrative Agent pursuant to Section 13.05(d) , from and after the effective date specified in each Assignment and Assumption, the assignee thereunder shall be a party to this Agreement and, to the extent of the interest assigned by such Assignment and Assumption, have the rights and obligations of the Lenders under this Agreement and the other Loan Documents, and correspondingly the assigning Lender shall, to the extent of the interest assigned by such Assignment and Assumption, be released from its obligations under this Agreement (and, in the case of an Assignment and Assumption covering all of a Lender’s rights and obligations under this Agreement, such Lender shall cease to be a party hereto) and the other Loan Documents but shall continue to be entitled to the benefits of Section 5 and Section 13.03 . Any assignment or transfer by a Lender of rights or obligations under this Agreement that does not comply with this Section 13.05(b) shall be treated for purposes of this Agreement as a sale by such Lender of a participation in such rights and obligations in accordance with Section 13.05(e) .

 

(c)           Amendments to Loan Documents . Each of Administrative Agent, the Lenders and the Obligors agrees to enter into such amendments to the Loan Documents, and such additional Security Documents and other instruments and agreements, in each case in form and substance reasonably acceptable to Administrative Agent, the Lenders and the Obligors, as shall reasonably be necessary to implement and give effect to any assignment made under this Section 13.05 .

 

(d)           Register . Administrative Agent, acting solely for this purpose as an agent of Borrower, shall maintain at one of its offices in the United States of America a register for the recordation of the name and address of any assignee of the Lenders and the Commitment and outstanding principal amount of the Loans owing thereto (the “ Register ”). The entries in the Register shall be conclusive, absent manifest error, and Borrower shall treat each Person whose name is recorded in the Register pursuant to the terms hereof as the “Lender” hereunder for all purposes of this Agreement, notwithstanding notice to the contrary. The Register shall be available for inspection by Borrower, at any reasonable time and from time to time upon reasonable prior notice.

 

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(e)           Participations . Any of the Lenders may at any time, without the consent of, or notice to, Borrower, sell participations to one or more Eligible Transferees, or, if an Event of Default has occurred and is continuing, to any Person (each, a “ Participant ”), in each case other than a natural person or Borrower or any of Borrower’s Affiliates or Subsidiaries, in all or a portion of such Lender’s rights and/or obligations under this Agreement (including all or a portion of the Commitment and/or the Loans owing to it); provided that (i) such Lender’s obligations under this Agreement shall remain unchanged, (ii) such Lender shall remain solely responsible to the other parties hereto for the performance of such obligations and (iii) Borrower shall continue to deal solely and directly with the Lenders in connection therewith.

 

Any agreement or instrument pursuant to which a Lender sells such a participation shall provide that such Lender shall retain the sole right to enforce this Agreement and to approve any amendment, modification or waiver of any provision of this Agreement; provided that such agreement or instrument may provide that such Lender will not, without the consent of the Participant, agree to any amendment, modification or waiver that would (i) increase or extend the term of such Lender’s Commitment, (ii) extend the date fixed for the payment of principal of or interest on the Loans or any portion of any fee hereunder payable to the Participant, (iii) reduce the amount of any such payment of principal, or (iv) reduce the rate at which interest is payable thereon to a level below the rate at which the Participant is entitled to receive such interest. Subject to Section 13.05(e) , Borrower agrees that each Participant shall be entitled to the benefits of Section 5 to the same extent as if it were a Lender and had acquired its interest by assignment pursuant to Section 13.05(b) . To the extent permitted by law, each Participant also shall be entitled to the benefits of Section 4.04(a) as though it were the Lender.

 

(f)           Limitations on Rights of Participants . A Participant shall not be entitled to receive any greater payment under Section 5.01 or 5.03 than a Lender would have been entitled to receive with respect to the participation sold to such Participant, unless the sale of the participation to such Participant is made with Borrower’s prior written consent.

 

(g)           Certain Pledges . The Lenders may at any time pledge or assign a security interest in all or any portion of its rights under this Agreement and any other Loan Document to secure obligations of the Lenders, including any pledge or assignment to secure obligations to a Federal Reserve Bank; provided that no such pledge or assignment shall release the Lenders from any of their obligations hereunder or substitute any such pledgee or assignee for the Lenders as a party hereto.

 

13.06     Survival. The obligations of Borrower under Sections 5.01 , 5.02 , 5.03 , 12.03 , 12.05 , 12.09 , 12.10 , 12.11 , 12.12 , 12.13 , 12.14 and Section 14 (solely to the extent guaranteeing any of the obligations under the foregoing Sections) shall survive the repayment of the Obligations and the termination of the Commitment and, in the case of the Lenders’ assignment of any interest in the Commitment or the Loans hereunder, shall survive, in the case of any event or circumstance that occurred prior to the effective date of such assignment, the making of such assignment, notwithstanding that the Lenders may cease to be “Lenders” hereunder. In addition, each representation and warranty made, or deemed to be made by a Notice of Borrowing, herein or pursuant hereto shall survive the making of such representation and warranty.

 

13.07     Captions. The table of contents and captions and section headings appearing herein are included solely for convenience of reference and are not intended to affect the interpretation of any provision of this Agreement.

 

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13.08         Counterparts. This Agreement may be executed in any number of counterparts, all of which taken together shall constitute one and the same instrument and any of the parties hereto may execute this Agreement by signing any such counterpart.

 

13.9         Governing Law. This Agreement and the rights and obligations of the parties hereunder shall be governed by, and construed in accordance with, the law of the State of New York.

 

13.10         Jurisdiction, Service of Process and Venue.

 

(a)           Submission to Jurisdiction .

 

(i)           Each Obligor, other than any such party incorporated or established in France and with respect to which Section 13.10(a)(ii) below shall apply, agrees that any suit, action or proceeding with respect to this Agreement or any other Loan Document to which it is a party or any judgment entered by any court in respect thereof may be brought initially in the federal or state courts in Houston, Texas or in the courts of its own corporate domicile and irrevocably submits to the non- exclusive jurisdiction of each such court for the purpose of any such suit, action, proceeding or judgment. This Section 13.10(a)(i) is for the benefit of Administrative Agent and the Lenders only and, as a result, neither Administrative Agent nor any Lender shall be prevented from taking proceedings in any other courts with jurisdiction. To the extent allowed by applicable Laws, Administrative Agent and the Lenders may take concurrent proceedings in any number of jurisdictions.

 

(ii)          Each Obligor incorporated or established in France, the Administrative Agent and each Lender agrees that any suit, action or proceeding with respect to this Agreement or any other Loan Document to which it is a party or any judgment entered by any court in respect thereof may be brought initially in the federal or state courts in Houston, Texas or in the courts of its own corporate domicile and irrevocably submits to the non-exclusive jurisdiction of each such court for the purpose of any such suit, action, proceeding or judgment.

 

(b)           Alternative Process . Subject to Section 13.10(a)(ii) above, nothing herein shall in any way be deemed to limit the ability of Administrative Agent or the Lenders to serve any such process or summonses in any other manner permitted by applicable law.

 

(c)           Waiver of Venue, Etc . Each Obligor irrevocably waives to the fullest extent permitted by law any objection that it may now or hereafter have to the laying of the venue of any suit, action or proceeding arising out of or relating to this Agreement or any other Loan Document and hereby further irrevocably waives to the fullest extent permitted by law any claim that any such suit, action or proceeding brought in any such court has been brought in an inconvenient forum. A final judgment (in respect of which time for all appeals has elapsed) in any such suit, action or proceeding shall be conclusive and may be enforced in any court to the jurisdiction of which such Obligor is or may be subject, by suit upon judgment.

 

(d)           Jurisdiction Clauses of Swiss Security Documents . Notwithstanding the jurisdiction clauses set out in the Swiss Security Documents entered into prior to the date of this Agreement, each of the Administrative Agent, the Lenders, the Borrower and the Swiss Guarantors hereby agrees that all disputes arising out of or in connection with any Swiss Security Document to which it is a party, including disputes on the conclusion, binding effect, amendment and termination of such Swiss Security Document, shall be resolved exclusively by the ordinary courts of the Republic and Canton of Geneva, Switzerland. The Administrative Agent (acting as administrative and collateral agent and, in relation to security created under the Swiss Security Documents by way of pledge, as direct representative of the Lenders) and each of the Lenders party to a Swiss Security Document in addition have the right to institute legal proceedings against the relevant security provider at the competent court designated in this Agreement, in which case Swiss law shall nevertheless be applicable to such Swiss Security Document.

 

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13.11     Waiver of Jury Trial. EACH OBLIGOR AND EACH LENDER HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY SUIT, ACTION OR PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT, THE OTHER LOAN DOCUMENTS OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY.

 

13.12     Waiver of Immunity. To the extent that any Obligor may be or become entitled to claim for itself or its Property or revenues any immunity on the ground of sovereignty or the like from suit, court jurisdiction, attachment prior to judgment, attachment in aid of execution of a judgment or execution of a judgment, and to the extent that in any such jurisdiction there may be attributed such an immunity (whether or not claimed), such Obligor, to the fullest extent permitted by law, hereby irrevocably agrees not to claim and hereby irrevocably waives such immunity with respect to its obligations under this Agreement and the other Loan Documents.

 

13.13     Entire Agreement. This Agreement and the other Loan Documents constitute the entire agreement among the parties with respect to the subject matter hereof and thereof and supersede any and all previous agreements and understandings, oral or written, relating to the subject matter hereof. EACH OBLIGOR ACKNOWLEDGES, REPRESENTS AND WARRANTS THAT IN DECIDING TO ENTER INTO THIS AGREEMENT AND THE OTHER LOAN DOCUMENTS OR IN TAKING OR NOT TAKING ANY ACTION HEREUNDER OR THEREUNDER, IT HAS NOT RELIED, AND WILL NOT RELY, ON ANY STATEMENT, REPRESENTATION, WARRANTY, COVENANT, AGREEMENT OR UNDERSTANDING, WHETHER WRITTEN OR ORAL, OF OR WITH ADMINISTRATIVE AGENT OR THE LENDERS OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT AND THE OTHER LOAN DOCUMENTS.

 

13.14     Severability. If any provision hereof is found by a court to be invalid or unenforceable, to the fullest extent permitted by applicable law the parties agree that such invalidity or unenforceability shall not impair the validity or enforceability of any other provision hereof.

 

13.15     No Fiduciary Relationship. Borrower acknowledges that Administrative Agent and the Lenders have no fiduciary relationship with, or fiduciary duty to, Borrower arising out of or in connection with this Agreement or the other Loan Documents, and the relationship between the Lenders and Borrower is solely that of creditor and debtor. This Agreement and the other Loan Documents do not create a joint venture among the parties.

 

13.16     Confidentiality. Administrative Agent and the Lenders agree to maintain the confidentiality of the Confidential Information (as defined in the Non-Disclosure Agreement (defined below)) in accordance with the terms of that certain confidentiality agreement dated January 27, 2014 between Borrower and Capital Royalty L.P. (the “ Non-Disclosure Agreement ”). Any new Lender that becomes party to this Agreement hereby agrees to be bound by the terms of the Non-Disclosure Agreement. The parties to this Agreement shall prepare a mutually agreeable press release announcing the completion of this transaction on the first Borrowing Date.

 

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13.17     USA PATRIOT Act. Administrative Agent and the Lenders hereby notify Borrower that pursuant to the requirements of the USA PATRIOT Act (Title III of Pub. L. 107-56 (signed into law October 26, 2001)) (the “ Act ”), they are required to obtain, verify and record information that identifies Borrower, which information includes the name and address of Borrower and other information that will allow such Lender to identify Borrower in accordance with the Act.

 

13.18     Maximum Rate of Interest. (a) Notwithstanding anything to the contrary contained in any Loan Document, the interest paid or agreed to be paid under the Loan Documents shall not exceed the maximum rate of non-usurious interest permitted by applicable Law (in each case, the “ Maximum Rate ”). If the Lenders shall receive interest in an amount that exceeds the Maximum Rate, the excess interest shall be applied to the principal of the Loans, and not to the payment of interest, or, if the excessive interest exceeds such unpaid principal, the amount exceeding the unpaid balance shall be refunded to the applicable Obligor. In determining whether the interest contracted for, charged, or received by the Lenders exceeds the Maximum Rate, the Lenders may, to the extent permitted by applicable Law, (i) characterize any payment that is not principal as an expense, fee, or premium rather than interest, (ii) exclude voluntary prepayments and the effects thereof, (iii) amortize, prorate, allocate, and spread in equal or unequal parts the total amount of interest throughout the contemplated term of the Indebtedness and other obligations of any Obligor hereunder, or (iv) allocate interest between portions of such Indebtedness and other obligations under the Loan Documents to the end that no such portion shall bear interest at a rate greater than that permitted by applicable Law.

 

(b)          If any provision of this Agreement or of any of the other Loan Documents would obligate Borrower or any other Obligor to make any payment of interest or other amount payable to any Lender in an amount or calculated at a rate which would be prohibited by law or would result in a receipt by such Lender of interest at a criminal rate (as such terms are construed under the Criminal Code (Canada)) then, notwithstanding such provisions, such amount or rate shall be deemed to have been adjusted with retroactive effect to the maximum amount or rate of interest, as the case may be, as would not be so prohibited by law or so result in a receipt by such Lender of interest at a criminal rate, such adjustment to be effected, to the extent necessary, as follows: (i) firstly, by reducing the amount or rate of interest required to be paid to such Lender, and (ii) thereafter, by reducing any fees, commissions, premiums and other amounts required to be paid to such Lender which would constitute “interest” for purposes of Section 347 of the Criminal Code (Canada). Any amount or rate of interest referred to in this Section 13.18(b) shall be determined in accordance with generally accepted actuarial practices and principles as an effective annual rate of interest over the term that the applicable Loan remains outstanding on the assumption that any charges, fees or expenses that fall within the meaning of “interest” (as defined in the Criminal Code (Canada)) shall, if they relate to a specific period of time, be pro-rated over that period of time and, in the event of a dispute, a certificate of a Fellow of the Canadian Institute of Actuaries appointed by the Administrative Agent shall be conclusive for the purposes of such determination.

 

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13.19     Certain Waivers.

 

(a)           Real Property Security Waivers .

 

(i)           Each Obligor acknowledges that all or any portion of the Obligations may be secured by a Lien or Liens upon real property evidenced by certain documents including, without limitation, mortgages, debentures, deeds of trust and assignments of rents. The Secured Parties may, pursuant to the terms of said real property security documents and applicable law, foreclose under all or any portion of one or more of said Liens by means of judicial or nonjudicial sale or sales. Each Obligor agrees that the Secured Parties may exercise whatever rights and remedies they may have with respect to said real property security, all without affecting the liability of any Obligor under the Loan Documents, except to the extent the Secured Parties realize payment by such action or proceeding. No election to proceed in one form of action or against any party, or on any obligation shall constitute a waiver of any Secured Party’s rights to proceed in any other form of action or against any Obligor or any other Person, or diminish the liability of any Obligor, or affect the right of the Secured Parties to proceed against any Obligor for any deficiency, except to the extent the Secured Parties realize payment by such action, notwithstanding the effect of such action upon any Obligor’s rights of subrogation, reimbursement or indemnity, if any, against Obligor or any other Person.

 

(ii)          To the extent permitted under applicable law, each Obligor hereby waives any rights and defenses that are or may become available to such Obligor by reason of Sections 2787 to 2855, inclusive, of the California Civil Code.

 

(iii)         To the extent permitted under applicable law, each Obligor hereby waives all rights and defenses that such Obligor may have because the Obligations are or may be secured by real property. This means, among other things:

 

(A)         the Secured Parties may collect from any Obligor without first foreclosing on any real or personal property collateral pledged by any other Obligor;

 

(B)          If the Secured Parties foreclose on any real property collateral pledged by any Obligor:

 

(1)         The amount of the Loans may be reduced only by the price for which that collateral is sold at the foreclosure sale, even if the collateral is worth more than the sale price; and

 

(2)         the Secured Parties may collect from each Obligor even if the Secured Parties, by foreclosing on the real property collateral, have destroyed any right that such Obligor may have to collect from any other Obligor.

 

(3)         To the extent permitted under applicable law, this is an unconditional and irrevocable waiver of any rights and defenses each Obligor may have because the Obligations are or may be secured by real property. These rights and defenses include, but are not limited to, any rights or defenses based upon Section 580a, 580b, 580d or 726 of the California Code of Civil Procedure.

 

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(iv)         To the extent permitted under applicable law, each Obligor waives all rights and defenses arising out of an election of remedies by the Secured Parties, even though that election of remedies, such as a nonjudicial foreclosure with respect to security for a guaranteed obligation, has destroyed such Obligor’s rights of subrogation and reimbursement against the principal by the operation of Section 580d of the California Code of Civil Procedure or otherwise.

 

(b)           Waiver of Marshaling . WITHOUT LIMITING THE FOREGOING IN ANY WAY, EACH OBLIGOR HEREBY IRREVOCABLY WAIVES AND RELEASES, TO THE EXTENT PERMITTED BY LAW, ANY AND ALL RIGHTS IT MAY HAVE AT ANY TIME (WHETHER ARISING DIRECTLY OR INDIRECTLY, BY OPERATION OF LAW, CONTRACT OR OTHERWISE) TO REQUIRE THE MARSHALING OF ANY ASSETS OF ANY OBLIGOR, WHICH RIGHT OF MARSHALING MIGHT OTHERWISE ARISE FROM ANY PAYMENTS MADE OR OBLIGATIONS PERFORMED.

 

13.20     Judgment Currency. If for the purpose of obtaining judgment in any court it is necessary to convert any amount owing or payable to the Lenders under this Agreement from the currency in which it is due (the “ Agreed Currency ”) into a particular currency (the “ Judgment Currency ”), the rate of exchange applied in that conversion shall be that at which such Lenders in accordance with their normal procedures, could purchase the Agreed Currency with the Judgment Currency at or about noon on the Business Day immediately preceding the date on which judgment is given. The obligation of any Obligor in respect of any amount owing or payable under this Agreement to the Lenders in the Agreed Currency shall, notwithstanding any judgment and payment in the Judgment Currency, be satisfied only to the extent that the Lenders in accordance with its normal procedures, could purchase the Agreed Currency with the amount of the Judgment Currency so paid at or about noon on the next Business Day following that payment; and if the amount of the Agreed Currency which the Lenders could so purchase is less than the amount originally due in the Agreed Currency, the applicable Obligor shall, as a separate obligation and notwithstanding the judgment or payment, indemnify the Lenders against any loss.

 

13.21     Limitations . Each of the parties hereto agree that any and all limitation periods provided for in any applicable law in respect of any action that may be commenced in respect of any Obligation, including the Limitations Act, 2002 (Ontario), shall be excluded from application to the Obligations and any undertaking, covenant, indemnity or other agreement of any Obligor provided for in any Loan Document to which it is a party in respect thereof, in each case to fullest extent permitted by such applicable law.

 

13.22     Permitted Liens . Any reference in any of the Loan Documents to a Permitted Lien is not intended to subordinate or postpone, and shall not be interpreted as subordinating or postponing, or as any agreement to subordinate or postpone, any Lien created by any of the Loan Documents to any such Permitted Lien.

 

13.23     Amendment and Restatement of the First A&R Agreement . The parties to this Agreement agree that, upon the execution and delivery by each of the parties hereto of this Agreement, the terms and provisions of the First A&R Agreement shall be and hereby are amended, superseded and restated in their entirety by the terms and provisions of this Agreement. This Agreement is not intended to and shall not constitute a novation. All “Loans” made and “Obligations” incurred or arising under the First A&R Agreement which are outstanding on the date hereof shall continue and be re-evidenced as Obligations under (and shall be governed by the terms of) this Agreement and the other Loan Documents. Each Obligor agrees, acknowledges and affirms that (i) each of the Loan Documents to which it is a party shall remain in full force and effect and, to the extent legally possible under the respective governing law, shall constitute security for all extensions of credit pursuant to the First A&R Agreement as amended and restated hereby and (ii) any reference to the First A&R Agreement appearing in any such Loan Document shall on and after the date hereof shall be deemed to refer to the First A&R Agreement as amended and restated hereby.

 

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13.24     English Guarantee and Security Confirmation.

 

(a)          In this Section 13.24 :

 

English Security Providers ” means the English Obligors, the Borrower and Cardiome International SA.

 

Guarantee Obligations ” means the guarantee and indemnity obligations of each English Obligor contained in the English Guarantee; and

 

Secured Obligations ” means (i) in the case of the English Debenture, the “Secured Liabilities” as defined therein; and (ii) in the case of the English Share Charges, the “Secured Sums” as defined therein.

 

(b)          Each English Obligor confirms for the benefit of the Administrative Agent and the Lenders that the Guarantee and all Guarantee Obligations shall:

 

(i)           remain in full force and effect notwithstanding the amendment and restatement of the First A&R Agreement on the terms of this Agreement (the “ Amendment and Restatement ”); and

 

(ii)          extend to any new obligations assumed by any Obligor under the Loan Documents as a result of the Amendment and Restatement (including, but not limited to, under this Agreement).

 

(c)          Each English Security Provider confirms for the benefit of the Administrative Agent and the Lenders that the Security (as defined in the applicable English Security Document) created by it pursuant to each English Security Document to which it is a party shall:

 

(i)           remain in full force and effect notwithstanding the Amendment and Restatement; and

 

(ii)          continue to secure its relevant Secured Obligations under the Loan Documents as amended (including, but not limited to, under this Agreement).

 

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SECTION 14

 

GUARANTEE

 

14.01     The Guarantee. The Subsidiary Guarantors hereby jointly and severally guarantee to the Secured Parties and their respective successors and assigns the prompt payment in full when due (whether at stated maturity, by acceleration or otherwise) of the principal of and interest on the Loans and all fees and other amounts from time to time owing to the Secured Parties by Borrower under this Agreement or under any other Loan Document and by any other Obligor under any of the Loan Documents, in each case strictly in accordance with the terms thereof (such obligations being herein collectively called the “ Guaranteed Obligations ”) . The Subsidiary Guarantors hereby further jointly and severally agree that if Borrower shall fail to pay in full when due (whether at stated maturity, by acceleration or otherwise) any of the Guaranteed Obligations, the Subsidiary Guarantors will promptly pay the same, without any demand or notice whatsoever, and that in the case of any extension of time of payment or renewal of any of the Guaranteed Obligations, the same will be promptly paid in full when due (whether at extended maturity, by acceleration or otherwise) in accordance with the terms of such extension or renewal.

 

14.02     Obligations Unconditional. The obligations of the Subsidiary Guarantors under Section 14.01 are absolute and unconditional, joint and several, irrespective of the value, genuineness, validity, regularity or enforceability of the obligations of Borrower under this Agreement or any other agreement or instrument referred to herein, or any substitution, release or exchange of any other guarantee of or security for any of the Guaranteed Obligations, and, to the fullest extent permitted by applicable law, irrespective of any other circumstance whatsoever that might otherwise constitute a legal or equitable discharge or defense of a surety or guarantor, it being the intent of this Section 14.02 that the obligations of the Subsidiary Guarantors hereunder shall be absolute and unconditional, joint and several, under any and all circumstances. Without limiting the generality of the foregoing, it is agreed that the occurrence of any one or more of the following shall not alter or impair the liability of the Subsidiary Guarantors hereunder, which shall remain absolute and unconditional as described above:

 

(a)          at any time or from time to time, without notice to the Subsidiary Guarantors, the time for any performance of or compliance with any of the Guaranteed Obligations shall be extended, or such performance or compliance shall be waived;

 

(b)          any of the acts mentioned in any of the provisions of this Agreement or any other agreement or instrument referred to herein shall be done or omitted;

 

(c)          the maturity of any of the Guaranteed Obligations shall be accelerated, or any of the Guaranteed Obligations shall be modified, supplemented or amended in any respect, or any right under this Agreement or any other agreement or instrument referred to herein shall be waived or any other guarantee of any of the Guaranteed Obligations or any security therefor shall be released or exchanged in whole or in part or otherwise dealt with; or

 

(d)          any lien or security interest granted to, or in favor of, the Secured Parties as security for any of the Guaranteed Obligations shall fail to be perfected.

 

The Subsidiary Guarantors hereby expressly waive diligence, presentment, demand of payment, protest and all notices whatsoever, and any requirement that any Secured Party exhaust any right, power or remedy or proceed against Borrower under this Agreement or any other agreement or instrument referred to herein, or against any other Person under any other guarantee of, or security for, any of the Guaranteed Obligations.

 

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14.03     Reinstatement. The obligations of the Subsidiary Guarantors under this Section 14 shall be automatically reinstated if and to the extent that for any reason any payment by or on behalf of Borrower in respect of the Guaranteed Obligations is rescinded or must be otherwise restored by any holder of any of the Guaranteed Obligations, whether as a result of any proceedings in bankruptcy or reorganization or otherwise, and the Subsidiary Guarantors jointly and severally agree that they will indemnify the Secured Parties on demand for all reasonable costs and expenses (including fees of counsel) incurred by the Lenders in connection with such rescission or restoration, including any such costs and expenses incurred in defending against any claim alleging that such payment constituted a preference, fraudulent transfer or similar payment under any bankruptcy, insolvency or similar law.

 

14.04     Subrogation. The Subsidiary Guarantors hereby jointly and severally agree that until the payment and satisfaction in full of all Guaranteed Obligations and the expiration and termination of the Commitments under this Agreement, they shall not exercise any right or remedy arising by reason of any performance by them of their guarantee in Section 14.01 , whether by subrogation or otherwise, against Borrower or any other guarantor of any of the Guaranteed Obligations or any security for any of the Guaranteed Obligations.

 

14.05     Remedies. The Subsidiary Guarantors jointly and severally agree that, as between the Subsidiary Guarantors and the Secured Parties, the obligations of Borrower under this Agreement and under the other Loan Documents may be declared to be forthwith due and payable as provided in Section 11 (and shall be deemed to have become automatically due and payable in the circumstances provided in Section 11 ) for purposes of Section 14.01 notwithstanding any stay, injunction or other prohibition preventing such declaration (or such obligations from becoming automatically due and payable) as against Borrower and that, in the event of such declaration (or such obligations being deemed to have become automatically due and payable), such obligations (whether or not due and payable by Borrower) shall forthwith become due and payable by the Subsidiary Guarantors for purposes of Section 14.01 .

 

14.06     Instrument for the Payment of Money. Each Subsidiary Guarantor hereby acknowledges that the guarantee in this Section 14 constitutes an instrument for the payment of money, and consents and agrees that the Secured Parties, at their sole option, in the event of a dispute by such Subsidiary Guarantor in the payment of any moneys due hereunder, shall have the right to proceed by motion for summary judgment in lieu of complaint pursuant to N.Y. Civ. Prac. L&R § 3213.

 

14.07     Continuing Guarantee. The guarantee in this Section 14 is a continuing guarantee, and shall apply to all Guaranteed Obligations whenever arising.

 

14.08     Rights of Contribution. The Subsidiary Guarantors hereby agree, as between themselves, that if any Subsidiary Guarantor shall become an Excess Funding Guarantor (as defined below) by reason of the payment by such Subsidiary Guarantor of any Guaranteed Obligations, each other Subsidiary Guarantor shall, on demand of such Excess Funding Guarantor (but subject to the next sentence), pay to such Excess Funding Guarantor an amount equal to such Subsidiary Guarantor’s Pro Rata Share (as defined below and determined, for this purpose, without reference to the properties, debts and liabilities of such Excess Funding Guarantor) of the Excess Payment (as defined below) in respect of such Guaranteed Obligations. The payment obligation of a Subsidiary Guarantor to any Excess Funding Guarantor under this Section 14.08 shall be subordinate and subject in right of payment to the prior payment in full of the obligations of such Subsidiary Guarantor under the other provisions of this Section 14 and such Excess Funding Guarantor shall not exercise any right or remedy with respect to such excess until payment and satisfaction in full of all of such obligations.

 

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For purposes of this Section 14.08 , (i) “ Excess Funding Guarantor ” means, in respect of any Guaranteed Obligations, a Subsidiary Guarantor that has paid an amount in excess of its Pro Rata Share of such Guaranteed Obligations, (ii) “ Excess Payment ” means, in respect of any Guaranteed Obligations, the amount paid by an Excess Funding Guarantor in excess of its Pro Rata Share of such Guaranteed Obligations and (iii) “ Pro Rata Share ” means, for any Subsidiary Guarantor, the ratio (expressed as a percentage) of (x) the amount by which the aggregate present fair saleable value of all properties of such Subsidiary Guarantor (excluding any shares of stock of any other Subsidiary Guarantor) exceeds the amount of all the debts and liabilities of such Subsidiary Guarantor (including contingent, subordinated, unmatured and unliquidated liabilities, but excluding the obligations of such Subsidiary Guarantor hereunder and any obligations of any other Subsidiary Guarantor that have been guaranteed by such Subsidiary Guarantor) to (y) the amount by which the aggregate fair saleable value of all properties of all of the Subsidiary Guarantors exceeds the amount of all the debts and liabilities (including contingent, subordinated, unmatured and unliquidated liabilities, but excluding the obligations of Borrower and the Subsidiary Guarantors hereunder and under the other Loan Documents) of all of the Subsidiary Guarantors, determined (A) with respect to any Subsidiary Guarantor that is a party hereto on the first Borrowing Date, as of such Borrowing Date, and (B) with respect to any other Subsidiary Guarantor, as of the date such Subsidiary Guarantor becomes a Subsidiary Guarantor hereunder.

 

14.09     General Limitation on Guarantee Obligations. In any action or proceeding involving any provincial, territorial or state corporate law, or any state, provincial, territorial or federal bankruptcy, insolvency, reorganization or other law affecting the rights of creditors generally, if the obligations of any Subsidiary Guarantor under Section 14.01 would otherwise, taking into account the provisions of Section 14.08 , be held or determined to be void, invalid or unenforceable, or subordinated to the claims of any other creditors, on account of the amount of its liability under Section 14.01 , then, notwithstanding any other provision hereof to the contrary, the amount of such liability shall, without any further action by such Subsidiary Guarantor, any Secured Party or any other Person, be automatically limited and reduced to the highest amount that is valid and enforceable and not subordinated to the claims of other creditors as determined in such action or proceeding.

 

14.10     Joint and Several Obligations. Notwithstanding any other provision contained herein or in any other Loan Document, if a “secured creditor” (as that term is defined under the Bankruptcy and Insolvency Act (Canada)) is determined by a court of competent jurisdiction not to include a Person to whom obligations are owed on a joint or joint and several basis, then the Borrower’s Obligations (and the Obligations of each other Obligor), to the extent such Obligations are secured, shall be several obligations and not joint or joint and several obligations.

 

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14.11     Restricted Obligations – Switzerland.

 

(a)          If and to the extent that a payment in fulfilling a liability of any Swiss Guarantor under this Agreement other than such Swiss Guarantor’s own liabilities or liabilities of one of its wholly-owned Subsidiaries (i.e. liabilities of such Swiss Guarantor’s direct or indirect parent companies (up-stream liabilities) or sister companies (cross-stream liabilities) or respective liabilities of the Swiss Guarantor or of any other party securing obligations of the Swiss Guarantor’s direct or indirect parent companies (up-stream liabilities) or sister companies (cross-stream liabilities)) would, at the time payment is due, under Swiss law and practice (inter alia, prohibiting capital repayments or restricting profit distributions) not be permitted (such obligations, “ Restricted Obligations ”), then such obligations and payment amount shall from time to time be limited to the amount permitted to be paid; provided, however, that such limited amount shall at no time be less than such Swiss Guarantor’s profits and reserves available for distribution as dividends (being, according to Swiss law as of the date of this Agreement, the balance sheet profits and any reserves available for this purpose, in each case in accordance with Swiss law and jurisprudence and Swiss accounting rules) at the time or times the relevant payment is requested from such Swiss Guarantor; which amount shall be determined on the basis of an audited balance sheet of such Swiss Guarantor and (i) be confirmed by the auditors of such Swiss Guarantor as distributable amount, and - to the extent required by Swiss law at the relevant time - (ii) be duly approved as distribution by a duly convened meeting of the shareholders of such Swiss Guarantor and further provided that such limitation (as may apply from time to time or not) shall not (generally or definitively) free such Swiss Guarantor from payment obligations hereunder in excess thereof, but merely postpone the payment date therefor until such times as payment is again permitted notwithstanding such limitation. Any and all indemnities and guarantees contained in the Loan Documents including, in particular, Section 4.04 shall be construed in a manner consistent with the provisions herein contained.

 

(b)          In respect of Restricted Obligations, each Swiss Guarantor shall:

 

(i)           if and to the extent required by applicable law in force at the relevant time:

 

(A)         subject to any applicable double taxation treaty, deduct Swiss anticipatory tax ( impôt anticipé/Verrechnungssteuer ) at the rate of 35% (or such other rate as in force from time to time) from any payment made by it in respect of Restricted Obligations;

 

(B)          pay any such deduction to the Swiss Federal Tax Administration; and

 

(C)          notify the Administrative Agent that such a deduction has been made and provide the Administrative Agent with evidence that such a deduction has been paid to the Swiss Federal Tax Administration; and

 

(ii)          to the extent such a deduction is made, any payment under this Agreement shall be increased to the extent necessary to ensure that the Lenders will receive a sum net of any such deduction or withholding equal to the sum which the Lenders would have received had no such deduction or withholding been made or required to be made.

 

(c)          If and to the extent requested by the Administrative Agent and if and to the extent this is from time to time required under Swiss law (restricting profit distributions), in order to allow the Administrative Agent and each Lender to obtain a maximum benefit from the relevant Swiss Guarantor’s liabilities under this Agreement, each Swiss Guarantor undertakes to promptly implement all such measures and/or to promptly obtain the fulfillment of all prerequisites allowing it to promptly make the requested payment(s) hereunder from time to time, including the following:

 

(i)           preparation of an up-to-date audited balance sheet of such Swiss Guarantor;

 

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(ii)          confirmation of the auditors of such Swiss Guarantor that the relevant amount represents the maximum freely distributable profits;

 

(iii)         approval by a shareholders’ or quotaholders’ (as applicable) meeting of the relevant Swiss Guarantor of the resulting profit distribution;

 

(iv)         if any obligation or payment amount would be limited as stated above, and to the extent permitted by applicable law, write up any of the assets of the relevant Swiss Guarantor that are shown in its balance sheet with a book value that is significantly lower than the market value of the assets, only to the extent that such assets are not necessary for the Swiss Guarantor’s business ( nicht betriebsnotwending ); and

 

(v)          all such other measures necessary or useful to enable the Swiss Guarantor to make payments and perform its obligations hereunder with a minimum of limitations.

 

14.12     Restricted Obligations – Germany.

 

(a)          In this Section 14.12 :

 

Auditors’ Determination ” shall have the meaning ascribed to that term in Section 14.12(f) .

 

Enforcement Notice ” shall have the meaning ascribed to that term in Section 14.12(e) .

 

German Guarantor ” means any Subsidiary Guarantor incorporated in Germany as (x) a limited liability company ( Gesellschaft mit beschränkter Haftung - GmbH ) (a “ German GmbH Guarantor ”) or (y) a limited partnership ( Kommanditgesellschaft ) with a limited liability company as general partner (a “ German GmbH & Co. KG Guarantor ”) in relation to whom any of the Lenders intends to demand payment under the guarantee set out in Article 14 .

 

Guaranteed Obligor ” shall have the meaning ascribed to that term in Section 14.12(b) .

 

Management Determination ” shall have the meaning ascribed to that term in Section 14.12(e) .

 

Net Assets ” means the relevant company’s assets (Section 266 para.(2) A, B, C, D and E German Commercial Code ( Handelsgesetzbuch ), less the aggregate of its liabilities (Section 266 para. (3) B (but disregarding any accruals ( Rückstellungen ) in respect of a potential enforcement of the Guarantee (as defined below) or any Transaction Security), C, D and E German Commercial Code), the amount of profits ( Gewinne ) not available for distribution to its shareholders in accordance with section 268 para. 8 German Commercial Code and the amount of its stated share capital ( Stammkapital ).

 

(b)          Each Lender agrees not to enforce the guarantee created under this Agreement (the “ Guarantee ”) if and to the extent that the Guarantee secures any liability of an Obligor which is an affiliated company ( verbundenes Unternehmen ) within the meaning of section 15 of the German Stock Corporation Act ( Aktiengesetz ) of a German Guarantor (other than that German Guarantor’s wholly -owned Subsidiaries) (the “ Guaranteed Obligor ”) and if and to the extent that a payment under the Guarantee would cause that German Guarantor’s (or, in the case of a German GmbH & Co. KG as Guarantor, its general partners’) Net Assets (determined pursuant to Section 14.12 (c), (e) and/or (f) ) to be reduced below zero ( Begründung einer Unterbilanz ), or further reduced ( Vertiefung einer Unterbilanz ) if already below zero.

 

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(c)          For the purposes of the calculation of the Net Assets the following balance sheet items shall be adjusted as follows:

 

(i)           the amount of any increase of the stated share capital ( Erhöhungen des Stammkapitals ) of the relevant German Guarantor after the date hereof that has been effected without the consent of the Lenders, shall be deducted from the stated share capital at that time;

 

(ii)          liabilities incurred by the relevant German Guarantor in violation of the Loan Documents; and

 

(iii)         indebtedness which is subordinated to any Indebtedness outstanding under this Agreement (including indebtedness in respect of guarantees for financial indebtedness which is so subordinated),

 

shall be disregarded.

 

(d)          In addition, the German Guarantor and, where the guarantor is a German GmbH & Co. KG Guarantor, also its general partner, shall realize, to the extent legally permitted and commercially reasonable with respect to the cost of such sale, in a situation where the enforcement of the Guarantee would cause the Net Assets to fall below zero or be further reduced if already below zero, any and all of its assets that are shown in in the balance sheet with a book value ( Buchwert ) that is significantly lower than the market value of the asset if such asset is not ncesessary for the German Guarantor’s or, as the case may be, its general partner’s, business ( betriebsnotwendig ).

 

(e)          The relevant German Guarantor shall deliver to the Lenders, within 20 Business Days after receipt from the Lenders of a notice stating that the Lenders intend to demand payment under this Guarantee (the “ Enforcement Notice ”), its up-to-date balance sheet, or in the case of a German GmbH & Co. KG Guarantor its and its general partner’s balance sheet, together with a reasonably detailed calculation of the amount of its Net Assets taking into account the adjustments set forth in Section 14.12(c) (the “ Management Determination ”). The Management Determination shall be prepared as of the date of receipt of the Enforcement Notice.

 

(f)          Following the Lenders’ receipt of the Management Determination, upon request by the Lenders, the relevant German Guarantor shall deliver to the Lenders within 30 Business Days of such request its up-to-date balance sheet, or in the case of a German GmbH & Co. KG Guarantor its and its general partner’s balance sheet, drawn-up by its auditor together with a detailed calculation of the amount of the Net Assets taking into account the adjustments set forth in Section 14.12(c) (the “ Auditors’ Determination ”). Such balance sheet and Auditors’ Determination shall be prepared in accordance with the accounting principles as consistently applied by the German Guarantors. The Auditors’ Determination shall be prepared as of the date of receipt of the Enforcement Notice.

 

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(g)          The Lenders shall be entitled to demand payment under this Guarantee in an amount which would, in accordance with the Management Determination or, if applicable and taking into account any previous enforcement in accordance with the Management Determination, the Auditors’ Determination, not cause the German Guarantor’s Net Assets, or in the case of a German GmbH & Co. KG Guarantor, its general partner’s Net Assets, to be reduced below zero or further reduced if already below zero. If and to the extent that the Net Assets as determined by the Auditors’ Determination are lower than the amount enforced (i) in accordance with the Management Determination or (ii) without regard to the Management and/or Auditors’ Determination, the Lenders shall release to the relevant German Guarantor (or in case of a German GmbH & Co. KG Guarantor to its general partner) such excess enforcement proceeds.

 

(h)          The restriction under Section 14.12(b) shall not apply:

 

(i)           to the extent that the Guarantee secures (A) any Loans that are on-lent, otherwise been passed on or actually disbursed to the relevant German Guarantor or any of its Subsidiaries and not repaid or (B) any guarantees issued under this Agreement for the benefit of the relevant German Guarantor or any of its Subsidiaries which are not returned;

 

(ii)          if the relevant German Guarantor (as dominated entity) is subject to a domination and/or profit transfer agreement ( Beherrschungs- und/oder Gewinnabführungsvertrag ) (a “ DPTA ”) with the Guaranteed Obligor, whether directly or indirectly through a chain of DPTAs between each company and its shareholder (or in case of a German GmbH & Co. KG Guarantor between its general partner and its shareholder) unless the existence of that DPTA does not prevent the violation of section 30 of the German Act on Companies with Limited Liabilities ( Gesetz betreffend die Gesellschaften mit beschränkter Haftung ) or

 

(iii)         if and to extent the relevant German Guarantor has on the date of enforcement of the Guarantee a fully recoverable indemnity or claim for refund (“ vollwertiger Gegenleistungs- oder Rückgewähranspruch ”) against its shareholder or the Guaranteed Obligor.

 

(i)           The limitations set forth in this Section 14.12 shall not affect the right of a Lender to claim again any amount outstanding at a later point in time if and to the extent that this Section 14.12 would allow this at such later point in time.

 

14.13     Restricted Obligations – France.

 

(a)          Notwithstanding any provision to the contrary in this Agreement, the obligations and liabilities of French Subsidiary Guarantor in respect of the guarantee under this Section 14 shall be subject to the following limitations:

 

(i)           The obligations and liabilities of any French Subsidiary Guarantor under this Section 14 shall not include any obligation or liability which, if incurred, would constitute the provision of financial assistance within the meaning of article L.225-216 of the French Commercial Code (Code de commerce ) and/or would constitute a misuse of corporate assets within the meaning of article L.241-3, L.242-6 or L.244-1 of the French Commercial Code ( Code de commerce ) or any other law or regulation having the same effect, as interpreted by the French courts.

 

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(ii)          Subject always to the provisions of Section 14.13(a)(i) above, the obligations and liabilities of any French Subsidiary Guarantor under this Section 14 for the obligations under this Agreement and the other Loan Documents of any other Obligor which is not a Subsidiary of such French Subsidiary Guarantor shall be limited at any time to an amount equal to the aggregate of all amounts directly or indirectly borrowed under this Agreement by such other Obligor to the extent directly or indirectly on-lent to such French Subsidiary Guarantor under intercompany loan agreement(s) and outstanding at the date a payment is made by such French Subsidiary Guarantor under this Section 14 , it being specified that any payment made by this French Subsidiary Guarantor under this Section 14 in respect of the obligations of such Obligor shall reduce pro tanto the outstanding amount of the intercompany loan(s) due by such French Subsidiary Guarantor under the intercompany loan agreement(s) referred to above and that any repayment of such intercompany loan(s) by the French Subsidiary Guarantor shall reduce pro tanto the amount payable by it under this Section 14 .

 

(iii)        Subject always to the provisions of Section 14.13(a)(i) above, the obligations and liabilities of any French Subsidiary Guarantor under this Section 14 for the obligations under this Agreement and the other Loan Documents of any other Obligor which is its Subsidiary shall not be limited and shall therefore cover all amounts due by such Obligor as Borrower and/or as Guarantor, provided that where such Subsidiary is not incorporated or established in France, the amounts payable by such French Subsidiary Guarantor for its obligations and liabilities referred to above in this Section 14.13(a)(iii) in respect of the obligations of this Subsidiary as Guarantor shall be limited as set out in Section 14.13(a)(ii) above (for the avoidance of doubt only, by reference to and within the limit of the amounts directly or indirectly on-lent to the French Subsidiary Guarantor by the Obligor whose obligations are guaranteed hereunder by the French Subsidiary Guarantor’s Subsidiary).

 

(b)          Notwithstanding any provision to the contrary in this Agreement, the representations made in Section 7 by a French Subsidiary Guarantor shall be made for itself and for each of its Subsidiaries only and the covenants made in Section 8 , Section 9 and Section 10 by a French Subsidiary Guarantor shall be made for itself and for each of its Subsidiaries only.

 

(c)          For the purpose of this Section 14.13 , “ Subsidiary ” means, in relation to any company, another company which is controlled by it within the meaning of article L.233-3 of the French Commercial Code ( Code de commerce ).

 

14.14     English Obligors. Notwithstanding any other provision of this Article 14, no English Obligor shall be subject to this Article 14. Each English Obligor shall at all times be subject to the English Guarantee.

 

[Signature Pages Follow]

 

  102  

 

 

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed and delivered as of the day and year first above written.

 

  BORROWER:

 

  CORREVIO PHARMA CORP.

 

  By: /s/ Justin Renz
    Name: Justin Renz
    Title: Chief Financial Officer

 

  By: /s/ William Hunter
    Name: William Hunter
    Title: President, CEO and Director

 

  Address for Notices:
  Correvio Pharma Corp.
  1441 Creekside Drive
  6 th Floor
  Vancouver, BC Canada V6J 4S7
   
  Attn: Legal Affairs
  Tel.: (604) 677-6905
  Fax: (604) 677-6915
  Email: legalaffairs@cardiome.com

 

Second A&R Term Loan Agreement

 

 

  SUBSIDIARY GUARANTORS:

 

  CORREVIO CANADA CORP.

 

  By: /s/ Justin Renz
    Name: Justin Renz
    Title: Director

 

  By: /s/ Sheila Grant
    Name: Sheila Grant
    Title: Director

 

  Address for Notices:
  Correvio Canada Corp.
  1441 Creekside Drive
  6 th Floor
  Vancouver, BC Canada V6J 4S7
   
  Attn: Legal Affairs
  Tel.: (604) 677-6905
  Fax: (604) 677-6915
  Email: legalaffairs@cardiome.com

 

Second A&R Term Loan Agreement

 

 

  CORREVIO LLC

 

  By: /s/ William Hunter
    Name: William Hunter
    Title: President

 

  By: /s/ Justin Renz
    Name: Justin Renz
    Title: Chief Financial Officer

 

  Address for Notices:
  Correvio LLC
  3 Dickinson Drive
  Suite 101
  Chadds Ford, PA 19317 USA
   
  with a copy to:
  c/o Correvio Pharma Corp.
  1441 Creekside Drive
  6 th Floor
  Vancouver, BC V6J 4S7 Canada
   
  Attn: Legal Affairs
  Tel.: (604) 677-6905
  Fax: (604) 677-6915
  Email: legalaffairs@cardiome.com

 

Second A&R Term Loan Agreement

 

 

  CARDIOME, INC.

 

  By: /s/ Justin Renz
    Name: Justin Renz
    Title: Director

 

  Address for Notices:
  c/o Corporation Service Company
  2711 Centerville Road
  Suite 400
  Wilmington, DE 19808 USA
   
  with a copy to:
  c/o Correvio Pharma Corp.
  1441 Creekside Drive
  6 th Floor
  Vancouver, BC V6J 4S7 Canada
   
  Attn: Legal Affairs
  Tel.: (604) 677-6905
  Fax: (604) 677-6915
  Email: legalaffairs@cardiome.com

 

Second A&R Term Loan Agreement

 

 

  ARTESIAN THERAPEUTICS, INC.

 

  By: /s/ Justin Renz
    Name: Justin Renz
    Title: Director

 

  Address for Notices:
  c/o Corporation Service Company
  2711 Centerville Road
  Suite 400
  Wilmington, DE 19808 USA
   
  with a copy to:
  c/o Correvio Pharma Corp.
  1441 Creekside Drive
  6 th Floor
  Vancouver, BC V6J 4S7 Canada
   
  Attn: Legal Affairs
  Tel.: (604) 677-6905
  Fax: (604) 677-6915
  Email: legalaffairs@cardiome.com

 

Second A&R Term Loan Agreement

 

 

  CARDIOME INTERNATIONAL SA

 

  By: /s/ Justin Renz
    Name: Justin Renz
    Title: Director

 

  By: /s/ David McMasters
    Name: David McMasters
    Title: Director

 

  Address for Notices:
  Rue des Alpes 21
  Case postale 1674
  1201 Geneva, Switzerland
   
  with a copy to:
  c/o Correvio Pharma Corp.
  1441 Creekside Drive
  6 th Floor
  Vancouver, BC V6J 4S7 Canada
   
  Attn: Legal Affairs
  Tel.: (604) 677-6905
  Fax: (604) 677-6915
  Email: legalaffairs@cardiome.com

 

Second A&R Term Loan Agreement

 

 

  CORREVIO INTERNATIONAL SARL

 

  By: /s/ Justin Renz
    Name: Justin Renz
    Title: Director

 

  By: /s/ David McMasters
    Name: David McMasters
    Title: Director

 

  Address for Notices:
  Rue des Alpes 21
  1201 Geneva Switzerland
   
  with a copy to:
  c/o Correvio Pharma Corp.
  1441 Creekside Drive
  6 th Floor
  Vancouver, BC V6J 4S7 Canada
   
  Attn: Legal Affairs
  Tel.: (604) 677-6905
  Fax: (604) 677-6915
  Email: legalaffairs@cardiome.com

 

Second A&R Term Loan Agreement

 

 

  CORREVIO (UK) LTD.

 

  By: /s/ Justin Renz
    Name: Justin Renz
    Title: Director

 

  By: /s/ Sheila Grant
    Name: Sheila Grant
    Title: Director

 

  Address for Notices:
  Lakeside House
  1 Furzeground Way,
  Stockley Park,
  Uxbridge, Middlesex,
  UB11 1BD
  United Kingdom
   
  with a copy to:
  c/o Correvio Pharma Corp.
  1441 Creekside Drive
  6 th Floor
  Vancouver, BC V6J 4S7 Canada
   
  Attn: Legal Affairs
  Tel.: (604) 677-6905
  Fax: (604) 677-6915
  Email: legalaffairs@cardiome.com

 

Second A&R Term Loan Agreement

 

 

  CARDIOME UK LIMITED

 

  By: /s/ Justin Renz
    Name: Justin Renz
    Title: Director

 

  Address for Notices:
  Lakeside House
  1 Furzeground Way,
  Stockley Park,
  Uxbridge, Middlesex,
  UB11 1BD
  United Kingdom
   
  with a copy to:
  c/o Correvio Pharma Corp.
  1441 Creekside Drive
  6 th Floor
  Vancouver, BC V6J 4S7 Canada
   
  Attn: Legal Affairs
  Tel.: (604) 677-6905
  Fax: (604) 677-6915
  Email: legalaffairs@cardiome.com

 

Second A&R Term Loan Agreement

 

 

  CORREVIO GMBH

 

  By: /s/ Justin Renz
    Name: Justin Renz
    Title: Director

 

  By: /s/ David McMasters
    Name: David McMasters
    Title: Director

 

  Address for Notices:
  Nikolaus Durkopp Str. 4A
  33602 Bielefeld Germany
   
  with a copy to:
  c/o Correvio Pharma Corp.
  1441 Creekside Drive
  6 th Floor
  Vancouver, BC V6J 4S7 Canada
   
  Attn: Legal Affairs
  Tel.: (604) 677-6905
  Fax: (604) 677-6915
  Email: legalaffairs@cardiome.com

 

Second A&R Term Loan Agreement

 

 

  ADMINISTRATIVE AGENT:

 

  CRG SERVICING LLC

 

  By: / s / Andrei Dorenbaum
    Name: Andrei Dorenbaum
    Title: Authorized Signatory

 

  Address for Notices:
  1000 Main Street
  Suite 2500
  Houston, TX 77002
   
  Attn: General Counsel
  Tel.: (713) 209-7350
  Fax: (713) 209-7351
  Email: adorenbaum@crglp.com

 

Second A&R Term Loan Agreement

 

 

  LENDERS:

 

  CRG PARTNERS III L.P.
  By CRG PARTNERS III GP L.P., its
  General Partner
  By CRG PARTNERS III GP LLC, its
  General Partner

 

  By: /s/ Andrei Dorenbaum
    Name: Andrei Dorenbaum
    Title: Authorized Signatory

 

  Address for Notices:
  1000 Main Street
  Suite 2500
  Houston, TX 77002
   
  Attn: General Counsel
  Tel.: (713) 209-7350
  Fax: (713) 209-7351
  Email: adorenbaum@crglp.com

 

  CRG PARTNERS III – PARALLEL FUND “A” L.P.
  By CRG PARTNERS III – PARALLEL FUND “A” GP L.P., its General Partner
  By CRG PARTNERS III – PARALLEL FUND “A” GP LLC, its General Partner

 

  By: /s/ Andrei Dorenbaum
    Name: Andrei Dorenbaum
    Title: Authorized Signatory

 

  Address for Notices:
  1000 Main Street
  Suite 2500
  Houston, TX 77002
   
  Attn: General Counsel
  Tel.: (713) 209-7350
  Fax: (713) 209-7351
  Email: adorenbaum@crglp.com

 

Second A&R Term Loan Agreement

 

 

  CRG PARTNERS III (CAYMAN) L.P.
  By CRG PARTNERS III (CAYMAN) GP L.P., its General Partner
  By CRG PARTNERS III (CAYMAN) GP LLC, its General Partner

 

  By: /s/ Andrei Dorenbaum
    Name: Andrei Dorenbaum
    Title: Authorized Signatory

 

  Address for Notices:
  1000 Main Street
  Suite 2500
  Houston, TX 77002
   
  Attn: General Counsel
  Tel.: (713) 209-7350
  Fax: (713) 209-7351
  Email: adorenbaum@crglp.com

 

  CRG PARTNERS III - PARALLEL FUND “B” (CAYMAN) L.P.
  By CRG PARTNERS III (CAYMAN) GP L.P., its General Partner
  By CRG PARTNERS III (CAYMAN) GP LLC, its General Partner

 

  By: /s/ Andrei Dorenbaum
    Name: Andrei Dorenbaum
    Title: Authorized Signatory

 

  Address for Notices:
  1000 Main Street
  Suite 2500
  Houston, TX 77002
   
  Attn: General Counsel
  Tel.: (713) 209-7350
  Fax: (713) 209-7351
  Email: adorenbaum@crglp.com

 

Second A&R Term Loan Agreement

 

Exhibit 4.3

 

CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
[…***…] 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

 

LICENSE AGREEMENT

 

Dated as of May 5, 2016

 

by and between

 

DURATA THERAPEUTICS INTERNATIONAL B.V.

 

and

 

CORREVIO INTERNATIONAL SÁRL

 

 

CONFIDENTIAL

 

TABLE OF CONTENTS

 

    Page
 
ARTICLE I
 
DEFINITIONS
 
ARTICLE II
 
LICENSE GRANTS
     
2.1 License Grants by Allergan 8
2.2 Additional Information 8
2.3 No Other Rights 8
     
ARTICLE III
 
GOVERNANCE
     
3.1 Joint Collaboration Committee 9
3.2 Meetings; Decision-Making 10
3.3 Subcommittees 11
3.4 Alliance Manager 11
     
ARTICLE IV
 
DEVELOPMENT AND COMMERCIALIZATION
     
4.1 Development Activities 11
4.2 Commercialization Activities 12
4.3 Plans and Reports 14
4.4 Sales Force 15
4.5 Trademarks 15
4.6 Product Claims 15
     
ARTICLE V
 
PAYMENTS
     
5.1 Milestone Payments 15
5.2 Royalties 17
5.3 Currencies and Payment; Interest 17
5.4 Taxes 18

 

  i  

CONFIDENTIAL

  

ARTICLE VI
 
REGULATORY AND PRICING MATTERS
     
6.1 Responsibility for Regulatory Approvals and Pricing Approvals 19
6.2 Pricing Approval 20
6.3 Regulatory Costs and Fees 20
6.4 Communications with Regulatory Authorities 20
6.5 Access to Data and Filings 20
6.6 Complaints 21
6.7 Drug Safety Information; Pharmacovigilance Agreement 21
     
ARTICLE VII
 
MANUFACTURE AND SUPPLY OF FINISHED PRODUCT
     
7.1 Commercial Supply 21
7.2 Quality/Technical Agreement 21
     
ARTICLE VIII
 
CONFIDENTIAL INFORMATION
     
8.1 Handling of Confidential Information 21
8.2 Exceptions 22
8.3 Publicity 22
     
ARTICLE IX
 
REPRESENTATIONS AND WARRANTIES; COVENANTS
     
9.1 Representations and Warranties 23
9.2 Licensee Representations and Warranties 24
9.3 Allergan Representations and Warranties 24
9.4 Covenants 24
     
ARTICLE X
 
PATENT AND TRADEMARK PROSECUTION, DEFENSE AND INFRINGEMENT
     
10.1 Ownership 25
10.2 Protection of Rights 26

 

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CONFIDENTIAL

 

10.3 Allergan Patent Rights 26
10.4 Cooperation 26
10.5 Third Party Infringement 26
10.6 Claimed Infringement 28
10.7 Other Infringement Resolutions 28
10.8 Trademarks 28
     
ARTICLE XI
 
INDEMNIFICATION; INSURANCE
     
11.1 Indemnification by Licensee 29
11.2 Indemnification by Allergan 29
11.3 Indemnification Procedure 30
11.4 Apportionment 30
11.5 Limitation of Liability 30
11.6 Insurance 31
     
ARTICLE XII
 
NON-COMPETITION
 
ARTICLE XIII
 
RECORDS
     
13.1 Financial Records 31
13.2 Retention of Records 32
     
ARTICLE XIV
 
TERM AND TERMINATION
     
14.1 Term 32
14.2 Mutual Termination Rights 32
14.3 Termination by Allergan 33
14.4 Effect of Termination 33
14.5 Survival 34
     
ARTICLE XV
 
MISCELLANEOUS
     
15.1 Relationship of the Parties 34

 

  iii  

CONFIDENTIAL

 

15.2 Registration and Filing of this Agreement 34
15.3 Force Majeure 35
15.4 Choice of Law 35
15.5 Dispute Resolution 35
15.6 Remedies Cumulative 37
15.7 Assignment 37
15.8 Notices 37
15.9 Invalid Provisions 38
15.10 Headings 38
15.11 Interpretation 39
15.12 Waiver 39
15.13 Entire Agreement; Amendments 39
15.14 No License 39
15.15 Third Party Beneficiaries 39
15.16 Counterparts 39
15.17 Compliance with Law 39
     
ARTICLE XVI
 
PARENT GUARANTEE
     
16.1 Guarantee 40
16.2 Representations and Warranties 40

 

EXHIBITS

 

Exhibit A  
Exhibit B  
Exhibit C  
Exhibit D  
Exhibit E  

 

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CONFIDENTIAL

  

LICENSE AGREEMENT

 

This License Agreement (this " Agreement "), effective as of May 5, 2016 (the " Effective Date "), is made by and between Durata Therapeutics International B.V., a private limited company registered in the Netherlands with offices at Barbara Strozzilaan 101, Spaces Zuida, Amsterdam, the Netherlands (" Allergan "), and Correvio International Sárl, a Swiss corporation with offices at Rue des Alpes 21, Case postale 1674, 1201 Geneva, Switzerland (" Licensee "). Each of Allergan and Licensee is referred to herein individually as a " Party " and collectively as the " Parties ." Certain capitalized terms have the meanings provided in Article I below.

 

WHEREAS, Allergan and/or its Affiliates Controls certain Patent Rights and Know-How with respect to the product known as dalbavancin;

 

WHEREAS, Allergan and Licensee desire that Licensee Commercialize the Product in the Territory for the Field on the terms and conditions of this Agreement; and

 

WHEREAS, simultaneously with the execution of this Agreement, Allergan and Licensee are entering into the Supply Agreement;

 

NOW, THEREFORE, for and in consideration of the foregoing and the representations, covenants and agreements contained herein, Allergan and Licensee, intending to be legally bound, hereby agree as follows:

 

ARTICLE I

 

DEFINITIONS

 

" Affiliate " shall mean, with respect to a Party, any Person that directly or indirectly controls, is controlled by, or is under common control with such Party. A Person shall be deemed to "control" another Person if (i) it owns, directly or indirectly, at least fifty percent (50%) of the issued and outstanding voting securities, capital stock, or other comparable equity or ownership interest of such other Person; or (ii) it has the de facto ability to control or direct the management of such other Person. If the Laws of the jurisdiction in which such Person operates prohibit ownership by a Person of fifty percent (50%) or more, "control" shall be deemed to exist at the maximum level of ownership allowed by such jurisdiction, provided , however , that there is a de facto ability to direct or control its management.

 

" Agent " of a Person shall mean employees, agents, advisers, representatives, consultants, accountants and counsel of such Person.

 

" Agreement " has the meaning set forth in the preamble hereto.

 

" Allergan " has the meaning set forth in the preamble hereto.

 

" Allergan Cost of Goods Sold " has the meaning set forth in the Supply Agreement.

 

 

CONFIDENTIAL

 

" Allergan Global Branding Strategy " shall mean Allergan's global commercial and branding strategy for the Product as in effect and provided by Allergan to Licensee from time to time.

 

" Allergan Global Pricing Strategy " shall mean Allergan's global pricing strategy for the Product as in effect and provided by Allergan to Licensee from time to time.

 

" Allergan Indemnitees " has the meaning set forth in Section 11.1 .

 

" Allergan IP " shall mean, collectively, Allergan Know-How, Allergan Patent Rights and Allergan Trademarks.

 

" Allergan Know-How " shall mean all Know-How Controlled by Allergan or its Affiliates during the Term relating to the Product, to the extent having application in the Field in the Territory.

 

" Allergan Patent Rights " shall mean all Patent Rights Controlled by Allergan or its Affiliates during the Term relating to the Product, to the extent having application in the Field in the Territory, including the patents and patent applications listed on Exhibit B .

 

" Allergan Trademarks " shall mean the trademark "XYDALBA" or such other Trademark as Allergan may reasonably select for Commercialization of the Product in any country in the Territory.

 

" Allergan's Knowledge " shall mean the actual knowledge of Thomas Poche without investigation.

 

" Alliance Manager " has the meaning set forth in Section 3.4 .

 

" Ancillary Agreements " shall mean the Supply Agreement, the Pharmacovigilance Agreement, the Quality/Technical Agreement and any other agreements contemplated hereunder.

 

" Annual Net Sales " shall mean the Net Sales of the Product in the Territory in a Calendar Year.

 

" Annual Plan " has the meaning set forth in Section 4.3(b) .

 

" Authorized Generic Version " shall mean a Generic Version of the Product which is being Commercialized by, or pursuant to a license or other authorization granted by, Allergan or its Affiliates.

 

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" Business Day " shall mean any day that is not a Saturday or a Sunday or a day on which banks are authorized or required to close in New York, New York, USA.

 

" Calendar Quarter " shall mean each respective period of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31, provided that the first Calendar Quarter shall be the period from the Effective Date through June 30, 2016.

 

" Calendar Year " shall mean each respective period of twelve (12) consecutive calendar months ending on December 31, provided that the first Calendar Year shall be the period from the Effective Date through December 31, 2016.

 

" Cardiome " has the meaning set forth in Section 16.1 .

 

" Claim " or " Claims " shall mean any charge, allegation, notice, civil, criminal or administrative claim, demand, complaint, cause of action, proceeding or investigation.

 

" Commercialization " and " Commercialize " shall mean activities relating to the import, advertising, promotion and other marketing, pricing and reimbursement, detailing, distribution, shipping, handling, offering for sale and selling, and customer service and support in relation to the Product. For the avoidance of doubt, "Commercialization" does not include Manufacturing of the Product.

 

" Commercially Reasonable Efforts " shall mean that degree of skill, effort, expertise, and resources normally used by a global pharmaceutical company, with respect to fulfilling a particular development, regulatory, or marketing activity for a compound owned by it or to which it has rights, which is of similar market potential at a similar stage in its product life relative to the Compound and the Product, taking into account the competitiveness of the marketplace, the proprietary position of the Compound and the Product, the regulatory structure involved, the profitability of the applicable products, and other relevant factors including technical, legal, scientific or medical factors.

 

" Competing Product " shall mean [...***...]

 

" Compound " shall mean dalbavancin, as described with greater specificity in Exhibit D .

 

" Confidential Information " shall mean any and all information and data, including all scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, financial, trade secret and commercial information or data, whether communicated in writing or orally or by any other method, which is provided by one Party or its Affiliates to the other Party or its Affiliates in connection with this Agreement. The terms of this Agreement shall also constitute Confidential Information of the Parties.

 

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" Control " or " Controlled " shall mean, with respect to any intellectual property right or other intangible property, the possession (whether by license or ownership, or by control over an Affiliate having possession by license or ownership) by a Party of the ability to grant to the other Party access and/or a license or sublicense as provided herein without violating the terms of any agreement with any Third Party.

 

" Damages " shall mean any and all any damages, losses, liabilities, costs and expenses (including court and arbitration costs and reasonable attorneys' fees), judicial or arbitration damage awards, and settlement payments.

 

" Develop " or " Development " shall mean activities relating to the pre-clinical and clinical drug development of the Product or the updating or review of product labeling, including test method development and stability testing, assay development, toxicology, formulation, quality assurance/quality control development, statistical analysis, pharmacokinetic studies, clinical trials (including research to design clinical trials) and any other research and development activities with respect to the Product in order to obtain Regulatory Approval of the Product.

 

" Disclosing Party " has the meaning set forth in Section 8.1 .

 

" Dispute " has the meaning set forth in Section 15.5(a) .

 

" Effective Date " has the meaning set forth in the preamble hereto.

 

" Ex Work Price per Unit " shall mean the net amount invoiced by Licensee, its Affiliates and permitted sublicensees to customers for sales of the Product in the Territory (but not including sales between Licensee, its Affiliates and permitted sublicensees) thus including in the calculation (i) by law trade discounts and (ii) customs or excise taxes including without limitation import duties, sales tax and other taxes (except income taxes but including as an example VAT) or duties relating to sales.

 

" Field " shall mean the Initial Indication and any New Indications approved for inclusion in the Field pursuant to Section 4.1(c) .

 

" Force Majeure " has the meaning set forth in Section 15.3 .

 

" GAAP " has the meaning set forth in this Article I .

 

" Generic Version " shall mean any product that contains the same active pharmaceutical ingredient(s) and is delivered through the same route of administration as the Product and is approved pursuant to an abbreviated regulatory process based on the clinical data for the Product and studies showing that such product is equivalent to such Product.

 

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" Governmental Authority " shall mean any court, tribunal, arbitrator, agency, commission, official or other instrumentality of (i) any government of any country; (ii) a federal, state, province, county, city or other political subdivision thereof; or (iii) any supranational body.

 

" Gross Profits " shall mean, [...***...]

 

" ICC " has the meaning set forth in Section 15.5(a) .

 

" Indemnitee " has the meaning set forth in Section 11.3 .

 

" Infringement Claim " has the meaning set forth in Section 10.6(a) .

 

" Initial Indication " means acute bacterial skin and skin structure infections.

 

" Initial Term " has the meaning set forth in Section 14.1 .

 

" Intellectual Property " shall mean, collectively, all intellectual property rights and similar proprietary rights, including Trademarks, copyrights, Know-How and Patent Rights, whether registered or unregistered, and all applications and registrations to register, and renewals and extensions of, any of the foregoing.

 

" JCC " has the meaning set forth in Section 3.1(a) .

 

" Know-How " shall mean information, technology, trade secrets, methods, knowledge, know-how, data (including clinical and regulatory data), records and documentation.

 

" Launch Date " shall mean, with respect to a given country in the Territory, the date of the first commercial sale of the Product in such country.

 

" Laws " shall mean all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any Governmental Authority, including the U.S. Foreign Corrupt Practices Act and the UK Bribery Act and the rules and regulations thereunder.

 

" License " has the meaning set forth in Section 2.1(a) .

 

" Licensee " has the meaning set forth in the preamble hereto.

 

" Licensee Indemnitees " has the meaning set forth in Section 11.2 .

 

" Manufacturing " or " Manufacture " shall mean, as applicable, all activities associated with the production, manufacture, processing, filling, finishing, packaging, labeling, and shipping, including process and formulation development, process validation, stability testing, manufacturing scale-up, pre-clinical, clinical and commercial manufacture and analytical development, product characterization, quality assurance and quality control development, testing and release.

 

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" Marketing Materials " has the meaning set forth in Section 4.2(a)(ii) .

 

" Minimum Pricing Approval " has the meaning set forth in Section 5.1(b) .

 

" Net Sales " shall mean, [...***...]

 

" New Indication " means any indication other than the Initial Indication.

 

" New Indication Notice " has the meaning set forth in Section 4.1(c) .

 

" Party " and " Parties " have the meaning set forth in the preamble hereto.

 

" Patent Rights " shall mean all patents (including all reissues, extensions, substitutions, confirmations, re-registrations, re-examinations, revalidations, supplementary protection certificates and patents of addition) and patent applications (including all provisional applications, requests for continuation, continuations, continuations-in-part and divisionals) and all equivalents of the foregoing in any country of the Territory.

 

" Person " shall mean any natural person, corporation, general partnership, limited partnership, joint venture, proprietorship or other business organization.

 

" Pharmacovigilance Agreement " shall mean the agreement referred to as such in Section 6.7 .

 

" Pre-Commercialization Plan " has the meaning set forth in Section 4.3(a) .

 

" Pricing Approval " shall mean price and reimbursement approvals wherever such approvals are required by the applicable Regulatory Authority in the Territory for sale of the Product in the country or other jurisdiction governed by such Regulatory Authority.

 

" Product " shall mean the pharmaceutical composition containing the Compound in finished pharmaceutical form as described with greater specificity in Exhibit C , including any and all presentations, analogs and formulations of such composition to be developed or approved by Allergan during the Term.

 

" Product Liability Claim " shall mean a Claim made by a Third Party that arises as a result of the use of the Product in the Territory during the Term that results in personal injury or death.

 

" Quality/Technical Agreement " shall mean the agreement referred to as such in Section 7.2.

 

" Recall " shall mean a recall of the Product in the Territory.

 

" Receiving Party " has the meaning set forth in Section 8.1 .

 

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CONFIDENTIAL

 

" Registration Dossier " shall mean, with respect to the Product, the package of technical and clinical information and data concerning such Product (and relevant manufacturing site) that is prepared by Allergan or its Affiliates for use in seeking any relevant Regulatory Approval.

 

" Regulatory Approval " shall mean, with respect to the Product in a particular country in the Territory, the receipt of all regulatory approvals (including Pricing Approval, if required) necessary for the distribution, marketing and sale of the Product in that country as granted by the relevant Regulatory Authority(ies).

 

" Regulatory Authority " shall mean any applicable Governmental Authority responsible for granting approvals for the Development or Commercialization of the Product in the Territory.

 

" Renewal Term " has the meaning set forth in Section 14.1 .

 

" Senior Executives " shall mean, in the case of Allergan, President, Branded Pharma or an executive that is the functional equivalent thereto, and in the case of Licensee, either Director, Correvio International Sárl, or, President and CEO, Cardiome Pharma Corp.

 

" Special Country(ies) " shall mean Egypt, Iran, Iraq, Saudi Arabia, Yemen, Syria, United Arab Emirates, Israel, Jordan, Palestine, Lebanon, Kuwait, Oman, Qatar, and Bahrain.

 

" Supply Agreement " shall mean that certain Supply Agreement for the Product signed by the Parties on the Effective Date and attached hereto as Exhibit A .

 

" Term " has the meaning set forth in Section 14.1 .

 

" Territory " shall mean the United Kingdom, Germany, France, Denmark, Iceland, Finland, Malta, Norway, Sweden, Belgium, Netherlands, Luxemburg, Ireland, Switzerland, Canada and the Special Countries.

 

" Third Party " shall mean a Person who is not a Party or an Affiliate of a Party.

 

" Trademark " shall mean any word, name, symbol, color, designation or devise or any combination thereof, including any trademark, trade dress, brand mark, service mark, trade name, brand name, logo or business symbol, whether or not registered.

 

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ARTICLE II

 

LICENSE GRANTS

 

2.1           License Grants by Allergan .

 

(a)           License . Subject to the terms and conditions of this Agreement, Allergan hereby grants to Licensee during the Term an exclusive, non-transferable (other than pursuant to Section 15.7) , sublicenseable (solely pursuant to Section 2.1(b)) , royalty-bearing license under Allergan IP to Develop, use, import, promote, market, offer for sale, sell, distribute and otherwise Commercialize the Product solely in the Field in the Territory (the " License "). Notwithstanding anything in this Agreement to the contrary, the License shall not include the right for Licensee to, and Licensee shall not, Manufacture, Commercialize or Develop any Generic Version of the Product.

 

(b)           Sublicensing . Licensee shall have the right to grant sublicenses of the License to its Affiliates upon written notice to Allergan and to Third Parties upon the prior written approval of Allergan, such approval not to be unreasonably withheld. Any such authorized sublicensee shall agree to comply with all applicable terms of this Agreement, and Licensee shall at all times be responsible and liable for the actions and omissions of such authorized sublicensee(s).

 

(c)           Allergan Trademark . Licensee will obtain Allergan's approval for any proposed use of any Allergan Trademark. Further, Licensee shall use the Allergan Trademarks in compliance with any guidelines provided by Allergan from time to time and, in any event, only in connection with the sale or offering for sale of the Product in the applicable country within the Territory.

 

(d)           Limitations on Rights . For clarity, Licensee has no rights under the Allergan IP to (and shall not) (i) Manufacture or have Manufactured the Product anywhere in the world or (ii) Develop, use, import, promote, market, offer for sale, sell, distribute or otherwise Commercialize the Product outside of the Territory.

 

2.2           Additional Information . Allergan agrees to provide Licensee, on reasonable request and without additional consideration, all information in Allergan's and/or its Affiliates' Control that is reasonably required in connection with Commercialization of the Product in the Territory.

 

2.3           No Other Rights . Except as otherwise expressly provided in this Agreement, under no circumstances shall a Party hereto, as a result of this Agreement, obtain any ownership interest, license or other right in any Intellectual Property of the other Party.

 

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ARTICLE III

 

GOVERNANCE

 

3.1           Joint Collaboration Committee .

 

(a)           Formation; Representatives . Within [...***...] after the Effective Date, the Parties shall establish a Joint Collaboration Committee (the " JCC ") to oversee all activities of the Parties contemplated by this Agreement and the Ancillary Agreements. The JCC shall be comprised of three (3) representatives designated by Licensee and three (3) representatives designated by Allergan, each of which shall be of the seniority and experience appropriate for participation therein, in light of the functions, responsibilities and authority of the JCC. One or more of the representatives designated by each Party shall have Development and Commercialization experience. Each Party shall make its designation of its representatives not later than [...***...] after the Effective Date. Each Party may change any one or more of its representatives at any time upon written notice to the other Party. If a Party's representative is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. In addition, each Party may, subject to the other Party's consent (not to be unreasonably withheld), invite non-voting employees, consultants or scientific advisors (provided they are engaged as such under written obligations of confidentiality no less protective of the Parties' Confidential Information than as set forth in Section 8.1) to attend the meetings of the JCC.

 

(b)           Scope of Authority . The responsibilities of the JCC shall be to generally oversee the Parties' activities pursuant to and in accordance with the terms of this Agreement and to serve as a forum for good faith communication and information exchange between the Parties. In addition, the responsibilities of the JCC shall include the following:

 

(i)          general oversight of and periodic review of the overall goals, strategy and progress of the Parties' activities hereunder;

 

(ii)         review and approval of the Pre-Commercialization Plan, and any amendments thereto;

 

(iii)        review and approval of the Annual Plans, and any amendments thereto;

 

(iv)        review and approval of the pricing of the Product, as contemplated under Article VI;

 

(v)         review and approval of all material branding and messaging relating to the Product in the Territory;

 

(vi)        review of Licensee's activities in connection with the Commercialization of the Product in the Field in the Territory; and

 

(vii)       serving as a vehicle for resolving issues escalated by the Parties to the JCC.

 

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3.2           Meetings; Decision-Making .

 

(a)           Meetings . The JCC shall meet [...***...] during the Term. The location of JCC meetings, when in person, shall alternate between Licensee's and Allergan's offices unless otherwise agreed by the Parties. At each meeting, the Parties shall provide updates on the status of their respective responsibilities under this Agreement and the Ancillary Agreements. The meetings of the JCC may be held by means of a telephone or video conference call or in person as mutually agreed by the Parties. The JCC may take action by vote at a meeting or telephone or video conference call, or pursuant to a written vote. Each Party shall bear its own travel and lodging expenses related to participation in and attendance at such meetings by its JCC representatives.

 

(b)           Chairpersons . The JCC shall have two (2) co-chairpersons, with each of Licensee and Allergan electing one (1) co-chairperson. None of the chairpersons shall have any greater authority than any other representative to the JCC. Each chairperson shall have the right to call a meeting in accordance with this Agreement and shall have the responsibility, working with the other Party's chairperson, to (i) prepare and issue drafts for review and minutes of each such meeting within [...***...] thereafter; (ii) ensure that any decision-making delegated to the JCC is carried out in accordance with this Section 3.2; and (iii) prepare and circulate an agenda in advance of all meetings.

 

(c)           Decision-Making .

 

(i)          All decisions of the JCC with respect to matters over which it has approval rights in accordance with this Article III shall be made by unanimous vote of the JCC's representatives, with each Party's representatives collectively having one (1) vote.

 

(ii)         In the event that the JCC is, after a period of [...***...] unable to make a decision due to a lack of required unanimity, either Party may submit the matter being considered to the Senior Executives for a joint decision. In such event, the JCC, by written notice to each Party, shall formally request that the dispute be resolved by the Senior Executives, specifying the nature of the dispute with sufficient specificity to permit adequate consideration by such Senior Executives. The Senior Executives shall diligently and in good faith, attempt to resolve the referred dispute expeditiously and, in any event, within [...***...] of receiving such written notification. For the avoidance of doubt, any disputes referred to the Senior Executives for resolution pursuant to this Section 3.2(c)(ii) shall not be subject to any dispute resolution mechanism or procedure other than pursuant to this Section 3.2(c)(ii) .

 

(iii)        In the event the Senior Executives are unable to reach a resolution of any referred dispute within such [...***...] period, the resolution and/or course of conduct of such matter shall be determined by [...***...].

 

(d)           Limited Authority . The JCC shall not have the authority to amend or modify the terms of this Agreement or any Ancillary Agreement, to expand the JCC's scope of authority or to determine any issue before the JCC in a manner that would conflict with the express terms and conditions of this Agreement.

 

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3.3           Subcommittees . The JCC may establish and disband subcommittees and working groups from time to time in the JCC's sole discretion.

 

3.4           Alliance Manager . Each Party shall appoint one of its employees as an " Alliance Manager " for this Agreement. Each Party's Alliance Manager shall be responsible for coordinating with the other Party's Alliance Manager regarding this Agreement and serving as a single point of contact for all aspects of this Agreement.

 

ARTICLE IV

 

DEVELOPMENT AND COMMERCIALIZATION

 

4.1           Development Activities .

 

(a)          Licensee will not Develop or have Developed the Products (including conducting medical or clinical trials of the Product or otherwise generating additional clinical data or performing additional analysis of existing clinical data for the Product) without the prior written approval of Allergan and pursuant to a mutually agreed upon clinical development program. In the case of studies required for Pricing Approval, Licensee may not conduct such studies without the prior written approval of Allergan, such approval not to be unreasonably withheld.

 

(b)          If mutually agreed upon by the Parties, Licensee shall Develop or co-Develop Products for sale in the Territory via participation in clinical trials conducted by Allergan outside of the Territory, via stand-alone trials within the Territory, via investigator-initiated clinical trials within the Territory or otherwise as agreed to by the Parties.

 

(c)          If Allergan has finalized a development plan and budget to develop the Product for any New Indication for Regulatory Approval in the United States, it shall notify Licensee in writing and provide such development plan and budget for such New Indication to Licensee (the " New Indication Notice " ). If Licensee is interested in such New Indication included within the Field, it shall notify Allergan within [...***...] from the date of the New Indication Notice, whereupon the parties shall discuss and seek to agree within [...***...] from the date of the New Indication Notice on (i) the portion of the Development costs associated with the Development of such New Indication payable by Licensee and (ii) the date upon which such New Indication shall be deemed included in the Field. If Licensee does not make the election set forth in the preceding sentence within such [...***...] period, or if the Parties do not reach agreement on Development cost sharing with respect to such New Indication within such […***…] period, then such New Indication shall not be included in the Field and Licensee shall have no rights with respect to such New Indication.

 

(d)          Allergan shall use Commercially Reasonable Efforts to:

 

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(i)          file with applicable Governmental Authorities in Canada and Switzerland all documents necessary for the Product to be used in a single dose regimen in such countries.

 

(ii)         conduct pediatric studies of the Product for the Territory (except for the Special Countries) as required by the applicable Regulatory Authorities in the Territory (except for the Special Countries).

 

(iii)        complete all post-Regulatory Approval actions for the Product in the Territory (except for the Special Countries) as required by the applicable Regulatory Authorities in the Territory (except for the Special Countries).

 

4.2           Commercialization Activities .

 

(a)           Licensee Commercialization Activities .

 

(i)          Subject to the terms and conditions of this Agreement, Licensee shall be responsible for all Commercialization activities in the Territory. Licensee shall use Commercially Reasonable Efforts to Commercialize the Product in the Territory for the Field. Licensee's Commercialization activities with respect to the Product in the Territory shall be in accordance with the Allergan Global Branding Strategy and the Annual Plan.

 

(ii)         Licensee shall create, at Licensee's expense, all marketing and technical information concerning the Product that is necessary or helpful in the Commercialization of the Product in the Territory, including scientific, marketing, promotional and instructional materials and advertising literature, publications (including publications arising out of investigator-initiated clinical trials), brochures and other Product data and materials (collectively, the " Marketing Materials "); provided , however , that Licensee shall obtain Allergan's written consent prior to its first use of any Marketing Materials. In addition, to the extent provided by Allergan, Licensee shall utilize scientific and marketing materials relating to the Products provided by Allergan in the Marketing Materials as directed by Allergan. All Marketing Materials shall include the Trademarks designated by Allergan to be included in such materials, including the Allergan Trademarks. All Trademarks used in such Marketing Materials shall remain the property of Allergan and in no event shall Licensee use the Allergan Trademarks or any Trademarks designated by Allergan for any purpose other than as provided in this Agreement. Any liability or Claim arising from the use or creation of such Marketing Materials shall be the sole responsibility of Licensee, except that Allergan shall be solely responsible for any such liability or Claim to the extent solely attributable to any information provided by Allergan to Licensee specifically for use in Marketing Materials.

 

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(iii)        Licensee shall participate in and conduct, at its own expense, significant symposia, conventions, and sales meetings as deemed by Licensee, in its reasonable discretion, important to the Commercialization of the Product in the Territory.

 

(iv)        Licensee shall notify Allergan of any and all proposed material meetings or activities with key opinion leaders reasonably in advance of such meetings and shall allow Allergan to participate in such material meetings and activities.

 

(v)         Licensee shall be responsible for the storage and distribution of the Product within the Territory and shall also be responsible for the import of the Product into any of the countries within the Territory if Allergan or its Affiliates does not itself import the Product or Manufacture the Product within such country.

 

(vi)        Licensee shall devote adequate, dedicated time-share of its brand team, including commercial, medical and sales personnel to the Commercialization of the Product in the Territory.

 

(vii)       Subject to Allergan providing training pursuant to Section 4.2(b)(i) below, Licensee shall ensure that all of its employees and agents who are engaged in the promotion, marketing and/or sale of the Product under this Agreement are adequately trained with respect to the Product.

 

(viii)      Subject to Section 3.2(c)(iii) , Licensee shall work together with Allergan in good faith to agree on a mutually acceptable branding and messaging strategy for the Product in the Territory consistent with the Allergan Global Branding Strategy.

 

(b)           Allergan Commercialization Activities .

 

(i)          Allergan shall provide (or offer to provide) to Licensee a reasonable level of Product-specific training (including training concerning medical information inquiries, adverse events and pharmacovigilance requirements) for Licensee personnel (e.g., sales force, medical liaisons or marketing personnel) in the Territory (excluding the Special Countries) at a mutually agreed upon time and place, as mutually agreed by the Parties.

 

(ii)         Allergan shall advise and keep Licensee reasonably informed each Calendar Quarter on all material developments related to the Product, whether they be of a scientific, developmental, manufacturing, quality, commercial (including pricing updates), regulatory or legal nature, to the extent such developments could reasonably be expected to materially affect Licensee's Commercialization of the Product in a country within the Territory that is not a Special Country; provided , however , if there is a matter of extraordinary significance concerning the Product, Allergan shall endeavor to provide Licensee with prompt notice of such event.

 

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(iii)        Allergan shall provide Licensee with scientific, marketing and promotional materials (and any changes to such materials) within its possession or control relating to the Product in the Territory (excluding the Special Countries) in a reasonable timeframe.

 

(iv)        Allergan shall reasonably make Allergan staff members knowledgeable in the Product available to Licensee on an as-needed basis upon reasonable prior notice to address any questions or concerns relating to the Product in the Territory (excluding the Special Countries).

 

(v)         Allergan shall provide Licensee with the Allergan Global Pricing Strategy.

 

(vi)        Subject to Section 3.2(c)(iii) , Allergan shall work together with Licensee in good faith to agree on a mutually acceptable branding and messaging strategy for the Product in the Territory consistent with the Allergan Global Branding Strategy.

 

4.3           Plans and Reports .

 

(a)          At least [...***...] prior to the first Launch Date of the Product in the Territory or, if the Parties reasonably expect the first Launch Date of the Product in any country in the Territory to be less than [...***...] from the Effective Date, then as soon as is practicable with respect to such country in the Territory, Licensee shall prepare and provide to Allergan and the JCC a written pre-Commercialization plan (the " Pre-Commercialization Plan ") describing in detail the planned Commercialization of the Product in the Territory for the [...***...] period following such Launch Date. The Pre-Commercialization Plan shall include the following information with respect to the Product in the Territory: a review of core markets, key drivers, competitors and key environmental issues, brand vision and strategy, brand positioning, value proposition for payers, forecast, lifecycle management and franchise maximization plans, resource plans (including sales and marketing costs), field force, advertising and promotion and medical affairs activities and expenses. The JCC shall review and approve the Pre-Commercialization Plan and any and all amendments thereto.

 

(b)          Within [...***...] after the Effective Date, Licensee shall prepare and provide to Allergan with a business plan, marketing plan and sales forecast (such plans and forecast, as amended and updated from time to time in accordance with this Section 4.3(b) , the " Annual Plan ") to cover in detail the Development and Commercialization of the Product in the Territory for the remainder of the first Calendar Year and the next full Calendar Year. The Annual Plan shall include the following information with respect to the Product in the Territory: brand vision and strategy (including positioning branding and key messaging), market and competitive map (including main opportunities for brand, key issues to address, market segmentation, business insight and market research plans), strategic communications (including global congresses, publication plans, ad boards/key opinion leader advocacy, Phase IV plans, medical education programs and public relations), price and market access considerations and plans, sales forecast (including sales, market share and days of therapy) and expenses (including sales force, advertising and promotion). Thereafter, Licensee shall, on an annual basis prepare and provide to Allergan an updated Annual Plan to cover the forthcoming Calendar Year. The JCC shall review and approve the Annual Plan and any and all amendments thereto.

 

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(c)          Within [...***...] after each Calendar Quarter, Licensee shall provide Allergan with (i) unit and sales volume reports of the Product with [...***...] rolling sales forecasts and competing product performance data; (ii) inventory reports of the Product by SKU; and (iii) sales reports of the Product in the Territory.

 

4.4           Sales Force . Licensee will promote the Product solely through its own and its Affiliates' sales force and will not rely upon contract sales forces unless consented to in advance in writing by Allergan.

 

4.5           Trademarks . The Product shall be promoted and sold in the Territory under the Allergan Trademarks licensed to Licensee pursuant to Section 2.1 . The Product (including all packaging and packaging inserts) and all promotional materials shall contain a statement, displayed prominently, that such Product was Manufactured by Allergan for distribution by Licensee unless otherwise prohibited by Law.

 

4.6           Product Claims . Licensee shall ensure that no claims or representations in respect of the Compound, the Product or the respective characteristics thereof are made by or on behalf of it or its Affiliates (by members of its sales force or otherwise) that do not represent an accurate summary or explanation of the labeling of the Product or a portion thereof.

 

ARTICLE V

 

PAYMENTS

 

5.1           Milestone Payments .

 

(a)           Initial Payment . As consideration for the rights and licenses granted hereunder, Licensee shall make a non-refundable payment to Allergan of Thirteen Million Dollars (U.S. $13,000,000) to be paid in two (2) installments as follows: (i) Five Million Dollars (U.S. $5,000,000) to be paid on or before [...***...] and (ii) Eight Million Dollars (U.S. $8,000,000) to be paid on or before [...***...]

 

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(b)           Milestones . As consideration for the rights and licenses granted hereunder, Licensee shall pay to Allergan the following, non-refundable, one-time milestone payment amounts following the achievement of the following milestones by Licensee:

 

Milestone   Payment Due as a Result of Achievement of Milestone
         
1.   [...***...]   [...***...]
         
2.   [...***...]   [...***...]
         
3.   The First Calendar Year in which Annual Net Sales equal or exceed [...***...]   [...***...]
         
4.   The First Calendar Year in which Annual Net Sales equal or exceed [...***...]   [...***...]
         
5.   The First Calendar Year in which Annual Net Sales equal or exceed [...***...]   [...***...]

 

If milestone 1 is achieved [...***...] then payment shall be due within [...***...]. If milestone 1 is not achieved [...***...] then payment shall be due within [...***...] after the milestone has been achieved. Payment under milestone 2 shall be due within [...***...] after the milestone has been achieved. Payment under each of milestones 3, 4 and 5 shall be due within [...***...] after the applicable Calendar Year in which such milestone has been achieved. For the avoidance of doubt, if achieved in the same Calendar Year, milestones 3, 4 and 5 will all be payable within the required time period following such Calendar Year, as provided in this paragraph.

 

For the further avoidance of doubt, the Parties agree that, in respect of milestones numbered 1 and 2 as detailed in the table above, Pricing Approval shall not be deemed to have been received in the relevant country until the required Pricing Approval of equal to or greater than [...***...] per vial (Ex Work Price per Unit) (" Minimum Pricing Approval ") is achieved in such country. For the further avoidance of doubt, the Parties agree that Licensee shall not be required to launch the Product in a given country until the applicable Minimum Pricing Approval in such country is achieved. Each milestone payment shall only be deemed earned as of the achievement of the corresponding milestone set forth above.

 

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5.2           Royalties .

 

(a)           Payment of Royalties . As consideration for the rights and licenses granted hereunder, Licensee shall pay to Allergan the tiered royalties set forth in Section 5.2(b) below on Annual Net Sales. Royalties will be payable on a quarterly basis and any such payments shall be made within [...***...] days after the end of the Calendar Quarter during which the applicable Net Sales occurred. Licensee's obligation to pay royalties pursuant to this Section 5.2 shall commence upon the first Launch Date and shall expire at the end of the Term.

 

(b)           Calculation of Royalties . The royalties payable under Section 5.2(a) shall be calculated based on Annual Net Sales for each Calendar Year as follows:

 

(i)          [...***...] on the portion of Annual Net Sales for such Calendar Year up to […***…];

 

(ii)         [...***...] on the portion of Annual Net Sales greater than [...***...] and up to [...***...]; and

 

(iii)        [...***...] on the portion of Annual Net Sales greater than [...***...].

 

For purposes of example, Annual Net Sales of [...***...] would result in a royalty due to Allergan equal to [...***...].

 

(c)           Generic Entry Event . If one (1) or more Generic Versions of the Product captures [...***...] or greater market share during a Calendar Quarter in any given country within the Territory, as measured by units, then the applicable royalty rate for such country for such Calendar Quarter shall be reduced by [...***...].

 

(d)           Reports . Each payment made to Allergan under this Section 5.2 shall be accompanied by a written report, showing, on a country-by-country basis with respect to the immediately preceding Calendar Quarter, (i) number of units of the Product sold in each country in the Territory, the Annual Net Sales in each country in the Territory and the calculation of the royalties due in aggregate for the Territory; and (ii) a good faith rolling forecast of expected royalties for the following [...***...] Calendar Quarters.

 

5.3           Currencies and Payment; Interest .

 

(a)          Wherever it is necessary to convert currencies in determining Net Sales, such conversion shall be made into Euros using the applicable average exchange rate for converting the applicable currency to the Euro as published by Bloomberg on the last Business Day of each month during the reporting Calendar Quarter. Wherever it is necessary to convert currencies in determining payments to be paid pursuant to this Agreement, such conversion shall be made into U.S. Dollars using the applicable average exchange rate for converting the applicable currency to the U.S. Dollar as published by Bloomberg on the last Business Day of each month during the reporting Calendar Quarter.

 

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(b)          All sums due under this Agreement shall be payable in U.S. Dollars by bank wire transfer in immediately available funds to such bank account as Allergan shall designate. Licensee shall be liable to pay interest to Allergan on all overdue amounts from the due date until the date the overdue outstanding amount is paid at the [...***...] plus […***…], but in no event higher than the highest rate permissible under Law.

 

5.4           Taxes .

 

(a)          Each Party is responsible for its own taxes, duties, levies, imposts, assessments, deductions, fees, withholdings or similar charges imposed on or measured by net income or overall gross income (including branch profits), gross receipts, capital, ability or right to do business, property, and franchise or similar taxes pursuant to applicable Law. Licensee will make all payments to Allergan under this Agreement without deduction or withholding for taxes except to the extent that any such deduction or withholding is required by applicable Law in effect at the time of payment. If applicable Law requires withholding of taxes from the payments due to Allergan set forth in this Article V , Licensee shall make such withholding payments as required and shall submit to Allergan appropriate proof of payment of the withholding reasonably satisfactory to Allergan as soon as practicable; provided that, if such withholding is required under the applicable Laws of any Governmental Authority other than any Governmental Authority of the Swiss Confederation including as a result of an assignment pursuant to Section 15.7 below, Licensee shall increase the amount so payable as necessary so that after such deduction or withholding has been made, Allergan receives the amount it would have received had no such deduction or withholding been made. If Licensee takes any actions that would increase any required withholding that otherwise would not be required absent such action, Licensee shall increase the amount so payable as necessary so that after such deduction or withholding has been made, Allergan receives the amount it would have received had no such deduction or withholding been made. Any such tax required to be withheld will be an expense of and borne by Allergan. Prior to making any deduction or withholding from any payment under this Agreement, Licensee shall provide at least [...***...] prior written notice to Allergan of the amounts subject to deduction or withholding and provide to Allergan a reasonable opportunity to furnish forms, certificates or other items that would reduce or eliminate such deduction or withholding. If Licensee receives a refund of any such withheld taxes, in whole or in part, and whether in the form of cash, credit or other similar offset, Licensee shall refund such amount to Allergan within a reasonable period of time, with the exception of withholding taxes for which, and solely to the extent that, Licensee has increased payable amounts to Allergan in accordance with this Section 5.4 (e.g., withholding taxes arising as a result of an assignment by Licensee pursuant to Section 15.7 below). Allergan shall not be liable for any penalties or interest due to the failure of Licensee to properly remit such any withholding or deductions to the Governmental Authorities.

 

(b)          Licensee and Allergan will cooperate with respect to all documentation required by any taxing authority or as reasonably requested by Licensee to secure a reduction in the rate of, or relief from, applicable withholding taxes.

 

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(c)          Licensee shall bear and pay for its own account all sales taxes, value added taxes, use or privilege taxes, excise taxes, import duties or similar duties and taxes and related interest and penalties levied (including, without limitation, all transactions covered in this Agreement, and, if applicable, any such payments arising as a result of royalty or milestone payments made under this Agreement), as required by applicable Law or as otherwise specifically discussed in the Supply Agreement contemplated in Article VII below.

 

ARTICLE VI

 

REGULATORY AND PRICING MATTERS

 

6.1           Responsibility for Regulatory Approvals and Pricing Approvals .

 

(a)          Allergan shall be responsible for and use Commercially Reasonable Efforts to obtain all Regulatory Approvals (excluding Pricing Approvals) for the Product for each indication in the Field in all countries in the Territory (excluding the Special Countries). For clarity, Allergan shall have no obligation to obtain Regulatory Approvals for the Product for any New Indication not included in the Field pursuant to Section 4.1(c) . All marketing authorization applications, regulatory submissions or Regulatory Approvals (excluding Pricing Approvals) in each country in the Territory (excluding the Special Countries) shall be owned by and held in the name of Allergan or its Affiliates unless Allergan, in its sole discretion, determines that such marketing authorization application, regulatory submission or Regulatory Approval should be held by Licensee or its Affiliates. Allergan shall use Commercially Reasonable Efforts to maintain all Regulatory Approvals (excluding Pricing Approvals) held by Allergan in accordance with applicable Law in the Territory (excluding the Special Countries), as applicable.

 

(b)          Licensee shall be responsible for and use Commercially Reasonable Efforts to obtain all Regulatory Approvals (including Pricing Approvals, as set forth in Section 6.2 herein) for the Product for each indication in the Field in the Special Countries. In such Special Countries, marketing authorization applications, regulatory submissions or Regulatory Approvals shall be owned by and held in the name of Licensee or its permitted sublicensee. Licensee shall use Commercially Reasonable Efforts to maintain all Regulatory Approvals in accordance with applicable Law in the Special Countries, as applicable. For the avoidance of doubt, Licensee shall consult with Allergan before submitting any marketing authorization application or regulatory submission in any Special Country, incorporate any reasonable comments of Allergan with respect to such marketing authorization application or regulatory submission and follow all instructions of Allergan with respect to Licensee's efforts to obtain Regulatory Approvals in the Special Countries.

 

(c)          Licensee shall file all Pricing Approvals in each country in the Territory (excluding the Special Countries) in the name of Allergan or its Affiliates. In countries where it is not possible to file Pricing Approval in the name of Allergan or its Affiliates, with the prior written consent of Allergan, Licensee (or its Affiliates) shall file for Pricing Approvals with relevant Governmental Authorities in its own name.

 

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6.2           Pricing Approval . Licensee shall use Commercially Reasonable Efforts to achieve the highest possible Pricing Approval in each country in the Territory in accordance with the Allergan Global Pricing Strategy; provided that without the prior written consent of Allergan, Licensee may not file or submit documentation with any Governmental Authority concerning or otherwise agree or commit to Pricing Approval of the Product in any country in the Territory of less than [...***...] per vial (Ex Work Price per Unit) of Product. Licensee shall share with Allergan, through the JCC, information relating to its discussions with Regulatory Authorities for Pricing Approval for the Product and shall consider in good faith any comments from Allergan or the JCC in relation thereto. Each Party shall have access to documentation that is within the other Party's possession or reasonable control relating to submissions for Pricing Approvals and may cross-reference such submissions for its own purposes with respect to the Product in their respective Territory.

 

6.3           Regulatory Costs and Fees . The Parties agree that, from the Effective Date, the costs and expenses in connection with obtaining (a) Pricing Approvals for the Product in all of the countries of the Territory as well as to maintain and renew such approvals and (b) Regulatory Approvals for the Product in the Special Countries, shall be borne by Licensee. For the avoidance of doubt, costs and expenses in connection with obtaining Regulatory Approval (other than Pricing Approval) in the Territory (other than the Special Countries) have been paid by Allergan as of the date hereof.

 

6.4           Communications with Regulatory Authorities . Except as otherwise set forth herein or as otherwise agreed by the Parties in writing, Allergan shall be solely responsible for all communications with Governmental Authorities related to the Product in the Territory (excluding the Special Countries) and Regulatory Approval thereof. Within the Special Countries, Licensee shall be primarily responsible for all communications with Governmental Authorities related to the Product and Regulatory Approval thereof, except that Licensee shall not file or submit any document relating to the Product in the Special Countries with any Governmental Authority without the prior written consent of Allergan or attend any meeting with any Governmental Authority relating to the Product without attendance by Allergan and shall provide Allergan with reasonable advance notice of all such filings, submissions and meetings to enable Allergan to comment on the proposed documents and prepare for any meetings. Licensee shall provide Allergan with [...***...] prior notice of any visit by a Governmental Authority to the premises of Licensee, its Affiliates or its sublicensees relating to the Product anywhere in the Territory.

 

6.5           Access to Data and Filings . Each Party shall have access to all data contained or referenced in submissions or applications for Regulatory Approvals in the Territory, which data, in the case of Licensee, shall only be used in connection with activities undertaken pursuant to this Agreement. Allergan shall use Commercially Reasonable Efforts to provide to Licensee a copy of the Registration Dossier within [...***...] from the Effective Date.

 

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6.6           Complaints . Each Party shall notify the other as soon as practicable of any complaints (other than medical complaints concerning the Product, the handling of which shall be subject to the Pharmacovigilance Agreement) received by it in accordance with standard operating procedures established by Allergan from time to time, and in sufficient detail to allow Allergan and Licensee to comply with any and all applicable Laws imposed upon them. Allergan and Licensee shall maintain complete and accurate records for such periods as may be required by applicable Law.

 

6.7           Drug Safety Information; Pharmacovigilance Agreement . The Parties shall in good faith negotiate and execute a mutually acceptable Pharmacovigilance Agreement addressing drug safety and adverse event reporting and compliance within [...***...] following the Effective Date.

 

ARTICLE VII

 

MANUFACTURE AND SUPPLY OF FINISHED PRODUCT

 

7.1           Commercial Supply . Allergan shall Manufacture the Product for use in the Territory pursuant to the Supply Agreement, subject to the provisions thereof.

 

7.2           Quality/Technical Agreement . In addition, the Parties shall negotiate and execute a Quality/Technical Agreement as further detailed in Section 5.1(b) of the Supply Agreement.

 

ARTICLE VIII

 

CONFIDENTIAL INFORMATION

 

8.1           Handling of Confidential Information . A Party (the " Receiving Party ") shall keep all Confidential Information received from or disclosed by the other Party or its Agents (the " Disclosing Party ") or to which the Disclosing Party gave the Receiving Party access with the same degree of care it maintains the confidentiality of its own Confidential Information. The Receiving Party shall not use such Confidential Information for any purpose other than in performance of this Agreement and the Ancillary Agreements or disclose the same to any other Person other than to such of its or its Affiliates' Agents who have a need to know such Confidential Information to implement the terms of this Agreement and the Ancillary Agreements. For the avoidance of doubt, Allergan may use Licensee's Confidential Information in connection with its Commercialization of the Product outside the Territory. The Receiving Party shall advise any Agent who receives such Confidential Information of the confidential nature thereof and of the obligations contained in this Agreement relating thereto, and the Receiving Party shall ensure that all such Agents comply with such obligations as if they had been a Party hereto. Upon termination of this Agreement, or earlier if so requested in writing by the Disclosing Party, the Receiving Party shall return or destroy all documents or other media containing such Confidential Information in its possession. All Confidential Information referenced in the first sentence of this Section 8.1 shall remain the property of the Disclosing Party.

 

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8.2           Exceptions . Each of Licensee and Allergan shall be relieved of any and all of the obligations of Section 8.1 with respect to a specific item of Confidential Information if such Confidential Information;

 

(a)          is in the public domain at the time of disclosure hereunder or subsequently comes within the public domain through no fault or action of the Receiving Party or its or its Affiliates' Agents; or

 

(b)          is in the possession or control of the Receiving Party or its or its Affiliates' Agents at the time of disclosure by or on behalf of the Disclosing Party, other than through a prior disclosure by or on behalf of the Disclosing Party, or is independently discovered, after the date of disclosure, by the Receiving Party or its or its Affiliates' Agents without the aid, application or use of the Confidential Information, in each such case as evidenced by written records; or

 

(c)          is obtained by the Receiving Party from any Third Party not in violation of any confidentiality obligation to the Disclosing Party not to disclose such Confidential Information; or

 

(d)          is necessarily disclosed in order to comply with the terms of this Agreement or the requirements of applicable Law, in the reasonable opinion of the Receiving Party's legal counsel; provided , however , that the Receiving Party shall use commercially reasonable efforts to notify the Disclosing Party of the Receiving Party's intent to make such disclosure of such Confidential Information sufficiently prior to making such disclosure so as to allow the Disclosing Party adequate time to take whatever action the Disclosing Party may deem to be appropriate to protect the confidentiality of the information.

 

8.3           Publicity . The Parties recognize that each Party may from time to time desire to issue press releases and make other public statements or disclosures regarding the subject matter of this Agreement. Any such press releases, news release or other public announcement relating to this Agreement or to the performance hereunder, shall first be reviewed and approved in writing by both Parties; provided , however , that any disclosure which is required by Law or the rules of the Securities and Exchange Commission or any securities exchange, as reasonably advised by the disclosing Party's counsel, may be made without the prior consent of the other Party, although the other Party shall be given prompt notice of any such legally required disclosure and to the extent practicable the disclosing Party shall provide the other Party an opportunity to comment on the proposed disclosure.

 

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ARTICLE IX

 

REPRESENTATIONS AND WARRANTIES; COVENANTS

 

9.1           Representations and Warranties . Allergan and Licensee each represents and warrants to the other as of the Effective Date that:

 

(a)           Due Execution and Enforceability . This Agreement has been duly executed and delivered by such Party and constitutes a legal, valid and binding obligation of such Party, enforceable against such Party in accordance with its terms, except as such enforceability may be limited by applicable insolvency and other laws affecting creditors' rights generally or by the availability of equitable remedies.

 

(b)           Power and Authority . Such Party:

 

(i)          is a company duly organized, validly existing and in good standing under the Laws of its jurisdiction of formation;

 

(ii)         is duly qualified as a company and in good standing under the Laws of each jurisdiction where its ownership or lease of property or the conduct of its business requires such qualification, where the failure to be so qualified would have a material adverse effect on its financial condition or its ability to perform its obligations hereunder;

 

(iii)        has the requisite power and authority and the legal right to conduct its business as now conducted and hereafter contemplated to be conducted;

 

(iv)        has all necessary licenses, permits, consents, authorizations or approvals from or by, and has made all necessary notices to, all Governmental Authorities having jurisdiction, to the extent required for the operation of its business; and

 

(v)         is in compliance with its organizational documents.

 

(c)           Due Authorization; No Conflicts . The execution, delivery and performance by such Party of this Agreement and the Ancillary Agreements to be entered into by the Parties pursuant to this Agreement and the performance of such Party's obligations hereunder and thereunder:

 

(i)          are within the company power of such Party;

 

(ii)         have been duly authorized by all necessary or proper company action;

 

(iii)        do not conflict with any provision of the organizational documents of such Party;

 

(iv)        do not conflict with or violate any requirement of applicable Laws applicable to such Party;

 

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(v)         do not and will not conflict with, violate or breach or constitute a default or require any consent under, any contractual obligations of such Party, except such consents as shall have been obtained prior to the Effective Date; and

 

(vi)        do not and will not require any filing or registration with or the license, permit, consent, approval or authorization of or any notice to any Governmental Authority, except such as shall have been obtained prior to the Effective Date or are contemplated herein to be made or obtained during the Term.

 

9.2           Licensee Representations and Warranties . Licensee represents and warrants to Allergan, as of the Effective Date, that Licensee has had an opportunity to conduct its own due diligence and consult with its own legal counsel, and tax, financial and other advisors, and that Licensee is not relying in that regard on Allergan. Licensee acknowledges that, except as otherwise expressly provided in this Agreement, Allergan is not making any representations or warranties whatsoever.

 

9.3           Allergan Representations and Warranties . Allergan represents and warrants to Licensee as of the Effective Date that:

 

(a)           No Notice of Infringement . To Allergan's Knowledge, the distribution, marketing and sale of the Product in its current formulation in the Territory under this Agreement do not infringe any issued and enforceable Patent Rights of any Third Party in the Territory.

 

(b)           Control of Allergan IP . Allergan owns or otherwise Controls the Allergan IP in the Territory, and has the right and authority to grant the rights and licenses granted pursuant to the terms and conditions set forth in this Agreement. Allergan has not granted any right, license, or interest in, to, or under the Allergan IP that is inconsistent with the rights, licenses, and interests granted under the terms and conditions set forth in this Agreement.

 

9.4           Covenants .

 

(a)           Allergan Covenants . Allergan hereby covenants and agrees that:

 

(i)          it will carry out its obligations or activities provided hereunder in accordance with (A) the terms of this Agreement; (B) accepted pharmaceutical industry practices; and (C) all applicable Laws. Allergan shall maintain all necessary licenses, permits, consents, authorizations, approvals or registrations from or by, and shall make all necessary notices and filings to, all Governmental Authorities having jurisdiction, to the extent required in order to fulfill its obligations under this Agreement.

 

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(ii)         in no event shall Allergan launch an Authorized Generic Version of the Product in a country within the Territory unless at least one other Generic Version of the Product has entered the market in such country. If Allergan launches an Authorized Generic Version of the Product in the Territory in accordance with this Section 9.4(a)(ii) , Allergan shall pay Licensee [...***...] of Gross Profits from the sale of such Authorized Generic Version of the Product in the Territory during the Term in consideration for Licensee's efforts in building the branded market for the Product in the Territory.

 

(b)           Licensee . Licensee hereby covenants and agrees that:

 

(i)          it will carry out the storage, handling, distribution, importation, detailing, promotion, marketing and sale of the Product and its other obligations or activities provided hereunder in accordance with (A) the terms of this Agreement; (B) accepted pharmaceutical industry practices; and (C) all applicable Laws. Licensee shall maintain all necessary licenses, permits, consents, authorizations, approvals or registrations from or by, and shall make all necessary notices and filings to, all Governmental Authorities having jurisdiction, to the extent required in order to fulfill its obligations under this Agreement.

 

(ii)         it will immediately notify Allergan in the event that Licensee, its Affiliates or Agents receives or otherwise becomes aware of any Product orders outside of the Territory and will not deliver or tender Product in fulfillment of such orders outside of the Territory without the prior written consent of Allergan.

 

(iii)        it will promptly provide to Allergan copies of all data, regulatory correspondence inside (as applicable) and outside of the Territory and analyses concerning the Product that are in Licensee's or its Affiliates' possession and will grant Allergan the right to cross-reference and cite such data, regulatory correspondence and analysis.

 

(c)           No Third Party Conflicts . During the Term, neither Party shall enter into any agreement with a Third Party which, in any way, will limit the Party's ability to perform all of the obligations that it has undertaken pursuant to this Agreement.

 

ARTICLE X

 

PATENT AND TRADEMARK PROSECUTION, DEFENSE AND INFRINGEMENT

 

10.1          Ownership . The Parties acknowledge and agree that, as between the Parties, except for the rights expressly granted herein, all right, title and interest in and to any Allergan IP or any other Intellectual Property rights in or covering the Product or generated by the Parties under this Agreement shall reside solely in Allergan. Any inventions made, developed, conceived or reduced to practice by or on behalf of Licensee that relate to the Product, and any Intellectual Property relating thereto, shall be owned solely by Allergan. Licensee hereby assigns and transfers to Allergan all right, title, and interest in and to such inventions and related Intellectual Property and agrees to take all further acts reasonably required to evidence such assignment and transfer to Allergan.

 

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10.2          Protection of Rights .

 

(a)          Licensee will not, and will not cause or assist another Person to, contest or dispute the validity of the Allergan IP or other Intellectual Property relating to the Product, or any part thereof, or the registrations thereof or Allergan's control of the Allergan IP or other Intellectual Property relating to the Product, or otherwise undermine the ability to market, promote or sell the Product. If Licensee at any time contests or disputes, or causes another Person to contest or dispute, the validity of the Allergan IP or other Intellectual Property relating to the Product or such control, or otherwise undermines the ability to market, promote or sell the Product, Allergan shall have the right to terminate this Agreement pursuant to Section 14.2(a) as if Licensee had committed a material breach, except that in such event no cure period shall apply, and Allergan shall have the right to effect such termination immediately upon written notice to Licensee, in its sole discretion.

 

(b)          Licensee shall not omit or alter any patent numbers, trade names, Trademarks, numbers, serial numbers or other Allergan markings affixed on the Product obtained from Allergan under the Supply Agreement, or alter the Product's labeling, except with the prior consent of Allergan.

 

10.3         Allergan Patent Rights . Allergan shall have the sole right to, at Allergan's discretion, file, conduct prosecution, and maintain (including the defense of any interference or opposition proceedings), all Allergan Patent Rights in the Territory and shall reasonably consult with Licensee in relation thereto from time to time.

 

10.4         Cooperation . Licensee hereby agrees to make its Agents reasonably available to Allergan or its Agents to the extent reasonably necessary to enable Allergan and its Agents to undertake prosecution and maintenance of Allergan Patent Rights and to cooperate, if necessary and appropriate, with Allergan in gaining patent term extensions wherever applicable to Patent Rights.

 

10.5         Third Party Infringement .

 

(a)           Notices . Each Party shall promptly report in writing to the other Party during the Term any (i) known or suspected infringement of any Allergan IP or other Intellectual Property relating to the Product in the Territory or (ii) unauthorized use or misappropriation of any Confidential Information, Allergan IP, or other Intellectual Property relating to the Product in the Territory by a Third Party of which it becomes aware, and shall provide the other Party with all available evidence supporting such infringement or unauthorized use or misappropriation.

 

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(b)           Rights to Enforce .

 

(i)           Outside of the Territory . Allergan shall have the sole and exclusive right (but not obligation) to initiate an infringement or other appropriate suit against any Third Party who at any time has infringed, or is suspected of infringing outside of the Territory, any Allergan IP or other Intellectual Property relating to the Product or is using, or suspected of using, without proper authorization any Know-How comprising Allergan IP outside the Territory.

 

(ii)          Territory . Allergan shall have the first right (but not obligation) to initiate an infringement or other appropriate suit against any Third Party who at any time has infringed, or is suspected of infringing in the Territory, any Allergan IP or other Intellectual Property relating to the Product or is using or suspected of using without proper authorization any Know-How comprising Allergan IP in the Territory. Allergan will consider in good faith any request from Licensee to initiate an infringement or other appropriate suit against any Third Party with respect to matters described in this Section 10.5(b)(ii ); provided , however , that Allergan shall not be required to initiate any such suit. In the event that Allergan does not promptly initiate and diligently prosecute such a suit reasonably requested by Licensee, then Licensee shall have the right, at its expense, to initiate and conduct such suit but shall not settle any such suit without obtaining the prior written consent of Allergan, which consent shall not be unreasonably withheld or delayed.

 

(c)           Procedures; Expenses . The Party having the right to initiate any infringement suit under Section 10.5(b) shall have the sole and exclusive right to select counsel for any such suit and shall assume and pay all of its own out-of-pocket costs incurred in connection with any such litigation or proceeding initiated by it, including counsel fees and expenses. If required under applicable Law, or otherwise necessary in order for the initiating Party to initiate or maintain such suit, the non-initiating Party shall join as a party to the suit. The non-initiating Party shall offer reasonable assistance to the initiating Party in connection therewith at no charge to the initiating Party except for reimbursement of reasonable out-of-pocket costs incurred in rendering such assistance. The non-initiating Party shall have the right to participate and be represented in any such suit by its own counsel at its own expense.

 

(d)           Recoveries . With respect to any suit referred to in Section 10.5(b)(ii) , any recovery obtained as a result of any such proceeding, by settlement or otherwise, shall be applied, subject to the respective indemnity obligations of the Parties set forth in Article XI , in the following order of priority: (i) first, each Party shall be reimbursed for all costs incurred in connection with such suit paid by such Party that were not reimbursed by the other Party, including attorneys' fees and disbursements, travel costs, court costs and other litigation expenses; and (ii) second, any remainder shall be treated as if such remainder were Net Sales under this Agreement; provided , however , that any recovery for punitive or exemplary damages shall be shared equally between the Parties.

 

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10.6         Claimed Infringement .

 

(a)           Notice . In the event that a Third Party at any time provides written notice of a Claim to, or brings an action, suit or proceeding against, any Party, or any of their Affiliates, claiming infringement of its Patent Rights or unauthorized use or misappropriation of its Know-How, based upon an assertion or Claim arising out of the Development, Manufacture or Commercialization of the Product in the Field (" Infringement Claim ") in the Territory, such Party shall promptly notify the other Party of the Claim, or the commencement of such action, suit or proceeding, by enclosing a copy of the Claim and all papers served. Each Party agrees to offer reasonable assistance to the other Party at no cost to the other Party.

 

(b)           Responsibility . Licensee shall defend and assume full responsibility for any Infringement Claims brought against either Party arising out of the Development, Manufacture or Commercialization of the Product within the Territory by or on behalf of Licensee or its Affiliates, and all Damages arising out of such Infringement Claims shall be borne by Licensee. Allergan shall defend and assume full responsibility for any Infringement Claims brought against either Party arising out of the Development, Manufacture or Commercialization of the Product outside of the Territory by or on behalf of Allergan or its Affiliates, and all Damages arising out of such Infringement Claims shall be borne by Allergan.

 

(c)           Procedure . Each Party shall have the sole and exclusive right to select counsel for any Infringement Claim that it defends; provided that it shall consult with the other Party with respect to the selection of counsel. Each Party will keep the other Party informed, and shall from time to time consult with the other Party regarding the status of any such Infringement Claims and shall provide the other Party with copies of all documents filed in any suit brought in connection with such claims. The other Party shall also have the right to participate and be represented in any such Claim or related suit to the extent such other Party is a defendant therein, at its own expense. No Party shall settle any claims or suits involving rights of another Party without obtaining the prior written consent of such other Party, which consent shall not be unreasonably withheld or delayed.

 

10.7         Other Infringement Resolutions . In the event of a dispute or potential dispute that has not ripened into a demand, Claim or suit of the types described in Section 10.5 and Section 10.6 of this Agreement (e.g., actions seeking declaratory judgments and revocation proceedings), the same principles regarding control of the resolution of the dispute, allocation of payments or receipt of Damages, and other procedures set forth in the foregoing sections shall apply.

 

10.8         Trademarks .

 

(a)          Each Party shall retain all right, title and interest in and to its respective company names and logos and no rights with respect to such company names and logos are granted to the other Party hereunder. Licensee hereby agrees to make its Agents reasonably available to Allergan or its Agents to the extent reasonably necessary to enable Allergan and its Agents to undertake prosecution and maintenance of the Allergan Trademarks and to cooperate, if necessary and appropriate, with Allergan in gaining renewals and extensions as and wherever applicable with respect to the Allergan Trademarks.

 

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(b)          In connection with its Commercialization activities hereunder, Licensee shall use only Allergan Trademarks with respect to the Product (provided that, Licensee shall pay all costs associated with registering and maintaining the Allergan Trademarks in the Territory) or, solely with Allergan's consent, in combination with Trademark(s) of Licensee and/or its logotype or solely under Trademark(s) of Licensee and/or its logotype.

 

(c)          Each Party shall own rights to any Internet domain names incorporating its applicable Trademarks or any variation or part of such Trademarks used as its URL address or any part of such address.

 

(d)          Licensee shall not register and/or use any domain or register and/or use any Trademark that is confusingly similar to the Allergan Trademarks without prior consent of Allergan.

 

(e)          Licensee shall comply with Allergan's quality standards with respect to the Allergan Trademarks as set forth in Exhibit E (and as may be updated by written notice from Allergan from time to time).

 

ARTICLE XI

 

INDEMNIFICATION; INSURANCE

 

11.1         Indemnification by Licensee . Licensee shall indemnify, hold harmless, and defend Allergan, its Affiliates, and their respective directors, officers, employees and agents (" Allergan Indemnitees ") from and against Damages brought or claimed by or on behalf of any Third Party (other than a Allergan Indemnitee) to the extent arising out of or resulting from, directly or indirectly, (a) any breach of this Agreement by Licensee Indemnitees; (b) the negligence or willful misconduct by or of Licensee Indemnitees; or (c) Licensee Indemnitees' activities in connection with the Development or Commercialization of the Product for use in the Territory, including Product Liability Claims, except, in each case of (a), (b) or (c), to the extent such Damages arise from any activity set forth in Sections 11.2(a), 11.2(b) or 11.2(c) for which Allergan is obligated to indemnify Licensee Indemnitees.

 

11.2         Indemnification by Allergan . Allergan shall indemnify, hold harmless, and defend Licensee, its Affiliates, and their respective directors, officers, employees and agents (" Licensee Indemnitees ") from and against any and all Damages brought or claimed by or on behalf of any Third Party (other than a Licensee Indemnitee) to the extent arising out of or resulting from, directly or indirectly, (a) any breach of this Agreement by Allergan Indemnitees; (b) the negligence or willful misconduct by or of Allergan Indemnitees; or (c) Allergan Indemnitees' activities in connection with the Development, Manufacture or Commercialization of the Product for use outside of the Territory, except, in each case of (a), (b) or (c), to the extent such Damages arise from any activity set forth in Sections 11.1(a), 11.1(b) or 11.1(c) for which Licensee is obligated to indemnify Allergan Indemnitees.

 

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11.3         Indemnification Procedure . In the event of any such Claim against any Licensee Indemnitee or Allergan Indemnitee (individually, an " Indemnitee "), the indemnified Party shall promptly notify the indemnifying Party in writing of the Claim for which indemnification is sought under this Article XI; provided that, failure to promptly notify the indemnifying Party shall relieve the indemnifying Party of any obligation to the indemnified Party under this Section 11.3 solely to the extent prejudicial to the indemnifying Party's ability to defend such action. The indemnifying Party shall, at its sole expense, defend and control such Claim with counsel of its own choosing; provided , however , that the indemnified Party may participate in the defense of such Claim with its own counsel and at its own expense. The indemnified Party shall, and shall cause its Indemnitees to, fully cooperate with the indemnifying Party in the investigation or defense of any Damages or Third Party Claim covered by this Article XI . The Indemnitees shall not settle such Claim without the indemnifying Party's prior written consent. The indemnifying Party shall not settle such Claim without the prior written consent of the Indemnitees against which such Claim was brought, which consent shall not be unreasonably withheld, conditioned or delayed. For the avoidance of doubt, in the event of any conflict between this Article XI and terms relating to Infringement Claims under Article X, Article X shall control.

 

11.4         Apportionment . In the event a Claim is based partially on an indemnified Claim described in Section 11.1 or Section 11.2 above and partially on a non-indemnified Claim, or is based partially on a Claim indemnified by one Party and partially on a claim indemnified by the other Party pursuant to Section 11.1 or Section 11.2 above, any Damages incurred in connection with such Claims are to be apportioned between the Parties in accordance with the degree of cause attributed to each Party.

 

11.5         Limitation of Liability . NEITHER PARTY SHALL BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES, INCLUDING LOST PROFITS, ARISING FROM OR RELATING TO THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 11.5 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER THIS AGREEMENT, OR THE RIGHTS OR OBLIGATIONS OF EITHER PARTY WITH RESPECT TO (A) THE INFRINGEMENT OR MISAPPROPRIATION OF THE OTHER PARTY'S INTELLECTUAL PROPERTY RIGHTS OR (B) UNAUTHORIZED USE OR DISCLOSURE OF THE OTHER PARTY'S CONFIDENTIAL INFORMATION.

 

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11.6         Insurance . Immediately upon first launch of the Product in the Territory, during the Term and for a period of [...***...] after the expiration of this Agreement or the earlier termination thereof, each Party shall obtain and/or maintain, respectively, at its sole cost and expense, product liability insurance with an aggregate limit of not less than [...***...]. Such product liability insurance shall insure against all liability, including personal injury, physical injury, or property damage arising out of, for Allergan, the Manufacture of the Product, and for Licensee, the Commercialization of the Product in the Territory. Each Party shall maintain additional insurance with respect to its activities and obligations under this Agreement in such amounts as are commercially reasonable in the industry for companies conducting similar business and shall require any of its Affiliates undertaking activities under this Agreement to do the same.

 

In connection with the execution of this Agreement, each Party, shall, upon the reasonable request of the other Party, deliver the relevant insurance certificates evidencing compliance with this Section 11.6 .

 

ARTICLE XII

 

NON-COMPETITION

 

During the Term and for a period of [...***...] following the Term (unless the Term has expired naturally pursuant to Section 14.1 or has been terminated by Licensee for breach pursuant to Section 14.2(a)) , Licensee agrees not to, and shall cause its Affiliates not to, directly or indirectly, alone or with any Third Party (a) detail, promote, market, Manufacture, produce or sell or otherwise Commercialize in the Territory any Competing Product (including Generic Versions of the Product); or (b) acquire any rights or interest in or to a Competing Product (including Generic Versions of the Product) which is being detailed, promoted, marketed or sold or otherwise Commercialized in the Territory. The Parties acknowledge and agree that the restrictions contained in this Article XII are reasonable in scope and duration and are properly required for the adequate protection of Allergan's rights hereunder and the value associated with the Product. The Parties further agree that if any portion of this Article XII is determined by an arbitrator or a court of competent jurisdiction to be unenforceable, this Article XII shall be interpreted to have the broadest application as shall be enforceable under applicable Law.

 

ARTICLE XIII

 

RECORDS

 

13.1         Financial Records . Licensee shall keep, and shall procure that its Affiliates and permitted sublicensees keep, such records of Net Sales and such other records as are necessary to determine accurately under GAAP, as applicable, the amounts due to Allergan under this Agreement. Such records shall be retained by Licensee or any of its Affiliates or permitted sublicensees. During normal business hours and with at least [...***...] advance written notice to Licensee, such records shall be made available for inspection, review and audit, for [...***...] after the applicable Calendar Year, at the request and expense of Allergan, by an independent certified public accountant or the local equivalent appointed by Allergan and reasonably acceptable to Licensee for the sole purpose of verifying the accuracy of Licensee's accounting reports and payments made or to be made pursuant to this Agreement; provided, however, that such audits may not be performed by Allergan more than once per Calendar Year. Such accountants shall be instructed to not reveal to Allergan the details of its review, except for (a) such information as is required to be disclosed under this Agreement and (b) such information presented in a summary fashion as is necessary to report the accountants' conclusions to Allergan, and shall be subject to confidentiality obligations consistent with the provisions of Article VIII. All costs and expenses incurred in connection with performing any such audit shall be paid by Allergan unless the audit discloses at least a [...***...] shortfall in payments to Allergan for the period audited, in which case Licensee will bear the full cost. Allergan will be entitled to recover any shortfall in payments due to it as determined by such audit, together with interest thereon in accordance with Section 5.3(b), or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments Allergan is otherwise required to make to Licensee under this Agreement.

 

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13.2         Retention of Records . The documents (a) from which were calculated the amounts due under Article V and (b) any records of, or relating to any filings to any Governmental Authority shall be retained by Allergan or Licensee (whichever is relevant) during the Term and for [...***...] years . thereafter.

 

ARTICLE XIV

 

TERM AND TERMINATION

 

14.1         Term . Unless earlier terminated pursuant to Section 14.2, the term of this Agreement shall commence on the Effective Date and continue in full force and effect for a period of [...***...] (the " Initial Term "). Thereafter, the Term may be extended by the Parties for [...***...] upon prior written agreement of the Parties (each, a " Renewal Term " and collectively, together with the Initial Term, the " Term ").

 

14.2         Mutual Termination Rights . Either Party shall at its sole discretion have the right (but not the obligation) to terminate this Agreement upon written notice to the other Party:

 

(a)           Breach . If the other Party materially breaches or defaults in the performance of any of the provisions of this Agreement, and such material breach or default is not cured, if capable of being cured, within [...***...] after the giving of notice by the first Party specifying such breach or default (except for any breach based upon failure to pay any amount when due hereunder, which shall have a cure period of [...***...] after the giving of notice by the first Party specifying such breach).

 

(b)           Force Majeure . If at any time during the Term of this Agreement there occurs and is continuing a Force Majeure which has lasted for at least [...***...] and has prevented the launch of the Product or continued marketing or sale of the Product in the Territory affected by such Force Majeure.

 

(c)           Insolvency . To the extent permitted by Law, if the other Party shall become insolvent, or shall make or seek to make or arrange an assignment for the benefit of creditors, or if proceedings in voluntary or involuntary bankruptcy shall be initiated by, on behalf of or against such Party (and, in the case of any such involuntary proceeding, not dismissed within [...***...] or if a receiver or trustee of such Party's property shall be appointed and not discharged within [...***...]

 

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14.3         Termination by Allergan . Allergan may terminate this Agreement (a) [...***...] if Licensee has not launched the Product within [...***...] after receipt of the Pricing Approval of the Product in such country and (b) otherwise in any other country in the Territory, if Licensee has not launched the Product within [...***...] after receipt of the Pricing Approval of the Product in such country, except that notwithstanding the foregoing, if Pricing Approval of the Product has already been received in a country in the Territory as of the Effective Date, Allergan may terminate this Agreement in such country if Licensee has not launched the Product in such country within [...***...] after the Effective Date.

 

14.4         Effect of Termination .

 

(a)          Termination or expiration of this Agreement shall:

 

(i)          not release either Party from any obligation to pay to the other Party any payments provided for under this Agreement that relate to periods prior to the date of termination or expiration;

 

(ii)         be without prejudice to any remedies which either Party may then have hereunder or under Law or in equity; and

 

(iii)        be without prejudice to either Party's right to obtain performance of any obligations provided for in this Agreement which survive termination by their express terms.

 

(b)          In addition:

 

(i)          all licenses and rights to Allergan IP granted to Licensee hereunder shall terminate;

 

(ii)         For a period of up to [...***...] following termination, Licensee or its Affiliates shall be entitled to sell any Product in its, or its Affiliates' possession as at the effective date of termination of this Agreement or purchased under the Supply Agreement in accordance with the terms (including the payment terms) of this Agreement and the Supply Agreement, unless Allergan terminates this Agreement pursuant to Section 14.2(a); and

 

(iii)        Licensee shall promptly transfer and assign ownership of all Pricing Approvals and Regulatory Approvals related to Products, including marketing authorization applications, regulatory submissions or Regulatory Approvals held in its name related to Products in the Special Countries, to Allergan or its designee, and shall take such other actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights hereunder to Allergan at no cost. The Parties agree to work together in good faith to effectuate transfers of Pricing Approvals and Regulatory Approvals related to Products in the Special Countries in each case in accordance herewith and in a manner that complies with applicable Law.

 

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14.5         Survival . In addition to any provisions of this Agreement that by their express terms would survive its expiration or termination, the following provisions shall survive any expiration or termination of this Agreement: Article VI, Article VIII, Article X, Article XI, Article XII, Article XIII, Article XIV, Article XV and Article XVI .

 

ARTICLE XV

 

MISCELLANEOUS

 

15.1         Relationship of the Parties . Each Party shall bear its own costs incurred in the performance of its obligations hereunder without charge or expense to the other except as expressly provided in this Agreement. Neither Party shall have any responsibility for the hiring, termination or compensation of the other Party's employees or for any employee benefits of such employees. No employee or representative of a Party shall have any authority to bind or obligate the other Party to this Agreement for any sum or in any manner whatsoever, or to create or impose any contractual or other liability on the other Party without said Party's approval. For all purposes, and notwithstanding any other provision of this Agreement to the contrary, Licensee's legal relationship under this Agreement to Allergan shall be that of independent contractor.

 

Nothing in this Agreement shall be construed to establish a relationship of co-partners or joint venturers between the Parties.

 

15.2         Registration and Filing of this Agreement . To the extent, if any, that either Party has reason to conclude that it is required to file or register this Agreement or a notification thereof with any Governmental Authority, including the U.S. Securities and Exchange Commission, the Competition Directorate of the Commission of the European Communities or the U.S. Federal Trade Commission, in accordance with Law, such Party shall inform the other Party thereof and both Parties shall cooperate each at its own expense in such filing or notification and shall execute all documents reasonably required in connection therewith; provided that such filing Party shall deliver a draft of the document(s), in redacted form or otherwise as such document(s) are proposed to be filed pursuant to this Section 15.2 , to the other Party at least [...***...] prior to the required filing date and such filing Party shall implement any and all further redactions or modifications reasonably requested by the other Party. In such filing or registration, the Parties shall request confidential treatment of sensitive provisions of this Agreement, to the extent permitted by Law. The Parties shall promptly inform each other as to the activities or inquiries of any such Governmental Authority relating to this Agreement, and shall cooperate to respond to any request for further information therefrom on a timely basis, provided that any further document(s) provided to any such Government Authority will be subject to the requirements of this Section 15.2 .

 

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15.3         Force Majeure . The occurrence of an event that materially interferes with the ability of a Party to perform its obligations or duties hereunder which is not within the reasonable control of the Party affected, not due to such Party's malfeasance, and which could not with the exercise of due diligence have been avoided (each, a " Force Majeure "), including an injunction, order or action by a Governmental Authority, fire, accident, labor difficulty, strike, riot, civil commotion, act of God, delay or errors by shipping companies or change in Law, shall not excuse such Party from the performance of its obligations or duties under this Agreement, but shall merely suspend such performance during the continuation of Force Majeure. The Party prevented from performing its obligations or duties because of Force Majeure shall promptly notify the other Party hereto of the occurrence and particulars of such Force Majeure and shall provide the other Party, from time to time, with its best estimate of the duration of such Force Majeure and with notice of the termination thereof. The Party so affected shall use reasonable efforts to avoid or remove such causes of nonperformance. Upon termination of Force Majeure, the performance of any suspended obligation or duty shall promptly recommence.

 

15.4         Choice of Law . All disputes, claims or controversies arising out of, relating to or in connection with this Agreement, including any question regarding its formation, existence, validity, enforceability, performance, interpretation or termination, shall be governed by the laws of the State of New York, USA (without reference to its choice of law or conflicts of law rules).

 

15.5         Dispute Resolution .

 

(a)           Disputes . The Parties shall negotiate in good faith and use reasonable efforts to settle any dispute, controversy or claim arising from, or related to, this Agreement or the breach hereof (each, a " Dispute "). In particular, the Senior Executives of the Parties shall attempt to resolve all Disputes. In the event that the Senior Executives cannot reach an agreement regarding a Dispute within [...***...] of such Dispute being referred to them for resolution by either Party, and a Party wishes to pursue the matter, each such Dispute shall be finally resolved by binding arbitration under the then-current Rules of Arbitration of the International Chamber of Commerce (" ICC ") by three (3) arbitrators appointed in accordance with the said Rules and Section 15.5(b) below, and judgment on the arbitration award may be entered in any court having jurisdiction thereof. Notwithstanding the foregoing, this Section 15.5(a) shall not apply to any dispute arising out of any matter which the JCC is authorized to approve or decide.

 

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(b)           Arbitration .

 

(i)          The arbitration shall be conducted by a panel of three (3) persons experienced in the pharmaceutical business who are independent of both Parties and neutral with respect to the Dispute presented for arbitration. Within [...***...] after initiation of arbitration, each Party shall select one (1) person to act as arbitrator and the two (2) Party-selected arbitrators shall select a third (3rd) arbitrator within [...***...] of their appointment. If the arbitrators selected by the Parties are unable or fail to agree upon the third (3rd) arbitrator, the third (3rd) arbitrator shall be appointed by the ICC International Court of Arbitration. The place of arbitration shall be New York, New York, USA, and all proceedings and communications shall be in English.

 

(ii)         Either Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved. Either Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that Party pending the arbitration award. The arbitrators shall have no authority to award punitive or any other type of Damages not measured by a Party's compensatory Damages. Each Party shall bear its own costs and expenses and attorneys' fees, and the Party that does not prevail in the arbitration proceeding shall pay the arbitrators' fees and any administrative fees of arbitration. Except to the extent necessary to confirm an award or as may be required by law, neither a Party nor an arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties. In no event shall an arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the dispute, controversy or claim would be barred by the applicable New York statute of limitations.

 

(iii)        The Parties agree that, in the event of a Dispute over the nature or quality of performance under this Agreement, neither Party may terminate this Agreement until final resolution of the Dispute through arbitration or other judicial determination. The Parties further agree that any payments made pursuant to this Agreement pending resolution of the Dispute shall be refunded promptly if an arbitrator or court determines that such payments are not due.

 

(iv)        The Parties hereby agree that any disputed performance or suspended performances pending the resolution of the arbitration that the arbitrators determine to be required to be performed by a Party must be completed within a reasonable time period following the final decision of the arbitrator.

 

(v)         The Parties hereby agree that any monetary payment to be made by a Party pursuant to a decision of the arbitrators shall be made in U.S. Dollars, free of any tax or other deduction. The Parties further agree that the decision of the arbitrators shall be the sole, exclusive and binding remedy between them regarding determination of the matters presented to the arbitrator.

 

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15.6         Remedies Cumulative . The remedies set forth in this Agreement (including termination rights) are cumulative and shall not be construed to restrict or otherwise affect any other remedies that may be available under any other agreement or under Law.

 

15.7         Assignment . This Agreement may not be assigned by either Party without the prior consent of the other Party; provided , however , that each Party shall have the right to assign its rights and obligations under this Agreement to any Third Party successor to all or substantially all of its entire business with written notice to the other Party. It is further understood and agreed that each Party may assign, or otherwise cause to be performed, its obligations under this Agreement (including obligations of confidentiality, processing and payment) to or by, as the case may be, one or more of its Affiliates. This Agreement shall be binding upon, and subject to the terms of the foregoing sentence, inure to the benefit of the Parties hereto, their successors, legal representatives and assigns.

 

15.8         Notices . All demands, notices, consents, approvals, reports, requests and other communications hereunder must be in writing and will be deemed to have been duly given only if delivered personally, by certified or registered mail, return receipt requested, or by overnight delivery using a globally-recognized carrier, to the Parties at the following addresses:

 

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Allergan: Durata Therapeutics International B.V.
  Barbara Strozzilaan 101
  Spaces Zuida,
  Amsterdam, The Netherlands
  Attention: General Manager
   
With copy to: Allergan plc
  Morris Corporate Center III
  400 Interpace Parkway
  Parsippany, NJ 07054
  United States
  Facsimile No.: [...***...]
  Attention: Chief Legal Officer
   
Licensee: General Counsel
  Correvio International Sárl
  Rue des Alpes 21
  Case Postale 1674
  1201 Geneva Switzerland
  Facsimile No.: +41 (0) 22 907 79 71
   
With copy to: General Counsel
  Cardiome Pharma Corp.
  1441 Creekside Drive, 6th Floor
  Vancouver, BC V6J 4S7
  Canada
  Facsimile No.: +1 604 677 6915

 

or to such other address as the addressee shall have last furnished in writing in accord with this Section 15.8 to the addressor. All notices shall be deemed effective upon receipt by the addressee.

 

15.9         Invalid Provisions . If any provision of this Agreement is held to be illegal, invalid or unenforceable under any applicable present or future Law, then such provision will be fully severable, and the remaining provisions of this Agreement will remain in full force and effect and will not be affected by the provision or by its severance herefrom.

 

15.10        Headings . The headings used in this Agreement have been inserted for convenience of reference only and do not define or limit the provisions hereof.

 

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15.11        Interpretation . Unless the context of this Agreement otherwise requires: (a) words of any gender include each other gender; (b) words using the singular or plural number also include the plural or singular number, respectively; (c) the terms "hereof," "herein," "hereby," and derivative or similar words refer to this entire Agreement; (d) the terms "Article," "Section" or "Exhibit" refer to the specified Article, Section or Exhibit of this Agreement; (e) the term "including" means "including without limitation"; and (f) "days" refers to calendar days. All accounting terms used but not otherwise defined herein have the meanings ascribed to such terms under the applicable accounting standards as applied to a Party. All references to " $ " amounts hereunder shall be deemed to be U.S. Dollars, and all payments due hereunder shall be made in U.S. Dollars.

 

15.12        Waiver . Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. No waiver by any Party of any term or condition of this Agreement, in any one or more instances, shall be deemed to be or construed as a waiver of the same or any other term or condition of this Agreement on any future occasion. The failure of either Party at any time or times to require performance of any provision hereof shall in no manner affect its rights at a later time to enforce the same.

 

15.13        Entire Agreement; Amendments . This Agreement (including the exhibits and schedules hereto) together with the Ancillary Agreements constitute the entire agreement between the Parties hereto with respect to the within subject matter and supersedes all previous agreements and understandings between the Parties, whether written or oral. This Agreement may be altered, amended or changed only by a writing making specific reference to this Agreement and signed by duly authorized representatives of Allergan and Licensee.

 

15.14        No License . Nothing in this Agreement shall be deemed to constitute the grant of any license or other right in either Party to or in respect of any product, patent, Trademark, Confidential Information, trade secret or other data or any other Intellectual Property of the other Party except as expressly set forth herein.

 

15.15        Third Party Beneficiaries . None of the provisions of this Agreement shall be for the benefit of or enforceable by any Third Party, including any creditor of either Party hereto. No such Third Party shall obtain any right under any provision of this Agreement or shall by reasons of any such provision make any Claim in respect of any debt, liability or obligation (or otherwise) against either Party hereto.

 

15.16        Counterparts . This Agreement may be executed in any two or more counterparts, each of which, when executed, shall be deemed to be an original and all of which together shall constitute one and the same document.

 

15.17        Compliance with Law . Notwithstanding any other provision of this Agreement, neither Party shall be required to undertake any activity or obligation under this Agreement which it has a reasonable belief may violate any applicable Laws; provided , however , a Party which so believes shall promptly inform the other Party of such belief.

 

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ARTICLE XVI

 

PARENT GUARANTEE

 

16.1         Guarantee . Cardiome Pharma Corp. (" Cardiome "), for itself and its successors in interest and assigns, hereby irrevocably and unconditionally guarantees the full and faithful payment and performance by Licensee of all of the payment and performance obligations of Licensee set forth in this Agreement or the Ancillary Agreements in strict accordance with the terms hereof. Pursuant to the foregoing, Cardiome is obligated to make each payment, and to perform each other obligation, contemplated by this Agreement or the Ancillary Agreements on the date when due, without notice to or demand upon Licensee or Cardiome. In addition, Cardiome does hereby waive notice of acceptance of this guaranty, notice of protest or compliance with the terms and provisions of this Agreement and the Ancillary Agreements and notice of non-performance or non-observance hereof. This guaranty, and payment and performance by Cardiome hereunder and thereunder, is in no way conditioned upon any requirement that Allergan first attempt to collect or enforce any obligation from or against Licensee, or upon any other event, action or inaction of any nature whatsoever.

 

16.2         Representations and Warranties . Cardiome represents and warrants to Allergan as follows:

 

(a)          Cardiome is a corporation duly incorporated and legally existing under the laws of the Canada. Cardiome has all requisite corporate power and authority to execute, deliver and perform its obligations under this Agreement.

 

(b)          This Agreement has been duly and validly executed and delivered by Cardiome.

 

(c)          This Agreement constitutes a legal, valid and binding agreement of Cardiome enforceable against Cardiome in accordance with its terms, subject to the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar laws relating to or affecting creditors' rights generally, general equitable principles (whether considered in a proceeding in equity or at law) and an implied covenant of good faith and fair dealing.

 

(d)          The execution and delivery by Cardiome of this Agreement do not, and the performance by Cardiome of this Agreement shall not, conflict with or violate in any material respect any applicable Law.

 

(e)          The execution and delivery by Cardiome of this Agreement do not, and the performance by Cardiome of this Agreement and each instrument required hereby shall not, require Cardiome to obtain any approval of any Person, observe any waiting period imposed by, or make any filing with or notification to, any Governmental Authority.

 

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THE BALANCE OF THIS PAGE IS LEFT BLANK INTENTIONALLY

 

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IN WITNESS WHEREOF, Allergan and Licensee, by their duly authorized officers, have executed this Agreement as of the date first written above.

 

DURATA THERAPEUTICS INTERNATIONAL B.V.   CORREVIO INTERNATIONAL SARL
         
By:     By:  
Name: Maurice Mulders   Name:  
Title: Director   Title:  
         
By:     By:  
Name: Jan Peters   Name:  
Title: Director   Title:  

 

ACCEPTED AND AGREED SOLELY WITH RESPECT TO ARTICLE XVI:

 

CARDIOME PHARMA CORP.

 

By:    
Name:  
Title:  

 

[Signature Page to License Agreement]

 

 

 

Exhibit 4.4

 

CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
[…***…] 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

 

Dated as of May 5, 2016

 

by and between

 

DURATA THERAPEUTICS INTERNATIONAL B.V.

 

and

 

CORREVIO INTERNATIONAL SÁRL

 

 

CONFIDENTIAL

 

TABLE OF CONTENTS

 

    Page
     
ARTICLE I  DEFINITIONS  
     
1.1 Definitions 1
     
ARTICLE II  MANUFACTURE AND SUPPLY OF PRODUCT  
     
2.1 Engagement 5
2.2 Representations and Warranties. 6
2.3 Packaging 6
2.4 Limitations 6
     
ARTICLE III  ORDER QUANTITIES, FORECASTING AND ORDERING  
   
3.1 Monthly Forecast 6
3.2 Information for Long-Term Planning 7
3.3 Amending Forecasts 7
3.4 Purchase Orders 8
3.5 Order Size 8
3.6 Allergan's Fulfillment of Purchase Orders 8
3.7 Minimum Shelf Life 8
     
ARTICLE IV DELIVERY; INVOICES  
   
4.1 Delivery 8
4.2 Certificates of Analysis 8
4.3 Certificate of Origin 8
4.4 Method of Invoicing 8
     
ARTICLE V  QUALITY ASSURANCE, PHARMACOVIGILANCE AND CHANGE MANAGEMENT  
     
5.1 Pharmacovigilance Agreement; Quality Agreement 9
5.2 Rejected Product 9
5.3 Disputed Product 9
5.4 Remedies for Non-Conforming Product 10
5.5 Change Management 10
5.6 Product Recalls 10
     
ARTICLE  VI PRICE, PAYMENTS AND REPORTING  
     
6.1 Price; Payments 11
6.2 Distribution Costs; Transfer and Other Taxes and Fees 11

 

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6.3 Audit Rights 11
     
ARTICLE VII  TERM AND TERMINATION  
     
7.1 Term 12
7.2 Effect of Expiration and Termination 12
     
ARTICLE VIII  INDEMNIFICATION; INSURANCE  
     
8.1 Indemnification by Licensee 12
8.2 Indemnification by Allergan 13
8.3 Indemnification Procedures 13
8.4 Apportionment 13
8.5 Limitation of Liability 13
8.6 Liability Cap 14
     
ARTICLE IX  MISCELLANEOUS  
     
9.1 Relationship of the Parties 14
9.2 Registration and Filing of this Agreement 14
9.3 Force Majeure 15
9.4 Choice of Law 15
9.5 Dispute Resolution 15
9.6 Remedies Cumulative 15
9.7 Assignment 15
9.8 Notices 16
9.9 Invalid Provisions 16
9.10 Headings 17
9.11 Interpretation 17
9.12 Waiver 17
9.13 Entire Agreement; Amendments 17
9.14 No License 17
9.15 Third Party Beneficiaries 17
9.16 Counterparts 17
9.17 Compliance with Law 18
9.18 Forms 18
9.19 Independent Contractors 18
9.20 Confidentiality 18

 

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SUPPLY AGREEMENT

 

This Supply Agreement (this "Agreement"), dated as of May 5, 2016 (the " Effective Date "), is made by and between Correvio International Sárl, a Swiss corporation with offices at Rue des Alpes 21, Case postale 1674, 1201 Geneva, Switzerland (" Licensee "), and Durata Therapeutics International B.V., a company registered in the Netherlands with offices at Spaces Zuidas II, Barbara Strozzilaan 101, 1083 HN Amsterdam, the Netherlands (" Allergan "). Each of Licensee and Allergan is referred to herein individually as a " Party " and collectively as the " Parties ." Certain capitalized terms have the meanings provided in Article I below.

 

WHEREAS, Licensee and Allergan have entered into a License Agreement, effective as of the Effective Date (as amended from time to time, the " License Agreement "), under which Allergan grants Licensee an exclusive right to Commercialize the Product in the Field in the Territory; and

 

WHEREAS, in connection with the License Agreement, Licensee and Allergan desire to enter into this Agreement in order to set forth the terms and conditions under which Allergan shall Manufacture (or cause to be Manufactured), supply and sell to Licensee, and Licensee shall purchase from Allergan, the Product.

 

NOW, THEREFORE, in consideration of the promises and mutual covenants contained herein and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties hereto agree as follows:

 

ARTICLE I

 

DEFINITIONS

 

1.1           Definitions .

 

As used in this Agreement, the following terms will have the meanings given to them below. Any capitalized terms used in this Agreement which are not defined in this Section 1.1 shall have the meanings given to them pursuant to the License Agreement.

 

" Affiliate " shall mean, with respect to a Party, any Person that directly or indirectly controls, is controlled by, or is under common control with such Party. A Person shall be deemed to "control" another Person if (i) it owns, directly or indirectly, at least fifty percent (50%) of the issued and outstanding voting securities, capital stock, or other comparable equity or ownership interest of such other Person, or (ii) it has the de facto ability to control or direct the management of such other Person. If the Laws of the jurisdiction in which such Person operates prohibit ownership by a Person of fifty percent (50%) or more, "control" shall be deemed to exist at the maximum level of ownership allowed by such jurisdiction, provided, however, that there is a de facto ability to direct or control its management.

 

" Agreed Tolerance " shall have the meaning set forth in Section 3.1(c) .

 

 

CONFIDENTIAL

 

" Agreement " shall have the meaning set forth in the Preamble.

 

" Allergan " shall have the meaning set forth in the Preamble.

 

" Allergan Cost of Goods Sold " shall mean, with respect to any Unit, [...***...] calculated in accordance with generally accepted accounting principles in the United States. Standard costs shall represent out of pocket costs plus direct material, direct labor, and manufacturing overhead allocated to the Manufactured Product based on applicable usage of the Manufacturing facility for the production of the Product.

 

" Allergan Indemnitees " shall have the meaning set forth in Section 8.1 .

 

" Auditor " shall have the meaning set forth in Section 6.3 .

 

" Binding Period " shall have the meaning set forth in Section 3.1(b) .

 

" Business Day " shall mean any day that is not a Saturday or a Sunday or a day on which banks are authorized or required to close in New York, New York.

 

" Calendar Year " shall mean each respective period of twelve (12) consecutive calendar months ending on December 31, provided, that the first Calendar Year shall be the period from the Effective Date through December 31, 2016.

 

" cGMP " shall mean the rules concerning current good manufacturing practices specified by the FDA regulations codified in the U.S. Code of Federal Regulations, the EU/PIC guidelines (and the corresponding national laws and regulations), or any other comparable regulatory criteria or guidelines as applicable, all as amended from time to time.

 

" Claim " or " Claims " shall mean any charge, allegation, notice, civil, criminal or administrative claim, demand, complaint, cause of action, proceeding or investigation.

 

" Commercialization " and " Commercialize " shall mean activities relating to the import, advertising, promotion and other marketing, pricing and reimbursement, detailing, distribution, shipping, handling, offering for sale and selling, and customer service and support in relation to the Product. For the avoidance of doubt, "Commercialization" does not include Manufacturing of the Product.

 

" Commercially Reasonable Efforts " shall mean that degree of skill, effort, expertise, and resources normally used by a global pharmaceutical company, with respect to fulfilling a particular development, regulatory, or marketing activity for a compound owned by it or to which it has rights, which is of similar market potential at a similar stage in its product life relative to the Compound and the Product, taking into account the competitiveness of the marketplace, the proprietary position of the Compound and the Product, the regulatory structure involved, the profitability of the applicable products, and other relevant factors including technical, legal, scientific or medical factors.

 

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" Compound " shall have the meaning set forth in the License Agreement.

 

" Damages " shall mean any and all any damages, losses, liabilities, costs and expenses (including court and arbitration costs and reasonable attorneys' fees), judicial or arbitration damage awards, and settlement payments.

 

" Delivery Location " shall have the meaning set forth in Section 4.1 .

 

" Discretionary Change " shall have the meaning set forth in Section 5.5(b) .

 

" Disputed Product " shall have the meaning set forth in Section 5.3 .

 

" Effective Date " shall have the meaning set forth in the Preamble.

 

" Facility(ies) " shall mean the manufacturing facility(ies) used by Allergan, its Affiliates or Subcontractors to perform Manufacturing hereunder.

 

" Final Packaged Form " shall mean a Product, fully packaged and labeled for sale in the applicable country in the Territory, including all applicable package inserts and labeling, including outer package labeling, in compliance with the applicable Regulatory Approval.

 

" Firm Orders " shall have the meaning set forth in Section 3.1(b) .

 

" Force Majeure " shall have the meaning set forth in Section 9.3 .

 

" Forms " shall have the meaning set forth in Section 9.18 .

 

" Governmental Authority " shall mean any court, tribunal, arbitrator, agency, commission, official or other instrumentality of (i) any government of any country, (ii) a federal, state, province, county, city or other political subdivision thereof or (iii) any supranational body.

 

" Indemnitee " shall have the meaning set forth in Section 8.3 .

 

" Intellectual Property " shall have the meaning set forth in the License Agreement.

 

" Laws " shall mean all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any Governmental Authority, including the U.S. Foreign Corrupt Practices Act and the UK Bribery Act and the rules and regulations thereunder.

 

" License Agreement " shall have the meaning set forth in the Recitals.

 

" Licensee " shall have the meaning set forth in the Preamble.

 

" Licensee Indemnitees " shall have the meaning set forth in Section 8.2 .

 

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" Manufacturing " or " Manufacture " shall mean, as applicable, all activities associated with the production, manufacture, processing, filling, finishing, packaging, labeling, and shipping, including process and formulation development, process validation, stability testing, manufacturing scale-up, pre-clinical, clinical and commercial manufacture and analytical development, product characterization, quality assurance and quality control development, testing and release.

 

" Non-Conformity " or " Non-Conforming " shall mean the failure of the Product to conform to the Specifications or the Packaging Information at the time of delivery to the Delivery Location in accordance with this Agreement.

 

" Packaging Information " shall have the meaning set forth in Section 2.3 .

 

" Party " or " Parties " shall have the meaning set forth in the Preamble.

 

" Person " shall mean any natural person, corporation, general partnership, limited partnership, joint venture, proprietorship or other business organization.

 

" Pharmacovigilance Agreement " shall have the meaning set forth in Section 5.1(a) .

 

" Planned Orders " shall have the meaning set forth in Section 3.1(d) .

 

" Product " shall have the meaning set forth in the License Agreement.

 

" Product Forecast " shall have the meaning set forth in Section 3.1(a) .

 

" Purchase Order " shall have the meaning set forth in Section 3.4.

 

" Purchase Price " shall have the meaning set forth in Section 6.1 .

 

" Quality Agreement " shall have the meaning set forth in Section 5.1(b) .

 

" Regulatory Approval " shall have the meaning set forth in the License Agreement.

 

" Regulatory Authority " shall mean any applicable Governmental Authority responsible for granting approvals for the development or Commercialization of the Product in the Territory.

 

" Rejected Product " shall have the meaning set forth in Section 5.2(a) .

 

" Required Changes " shall have the meaning set forth in Section 5.5(a).

 

" Semi-Binding Forecast " shall have the meaning set forth in Section 3.1(c) .

 

" Semi-Binding Period " shall have the meaning set forth in Section 3.1(c) .

 

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" Shelf Life " shall mean the length of time that the Product remains stable without degrading to unacceptable levels, as set forth in the Regulatory Approval.

 

" SKU " shall have the meaning set forth in Section 3.5 .

 

" Specifications " shall mean all applicable specifications for the Product.

 

" Subcontractor " shall mean any Third Party contracted by Allergan or its Affiliates to perform any of its Manufacturing obligations pursuant to this Agreement.

 

" Sublicensees " shall have the meaning set forth in the License Agreement.

 

" Term " shall have the meaning set forth in the License Agreement.

 

" Territory " shall have the meaning set forth in the License Agreement.

 

" Third Party " shall mean a Person who is not a Party or an Affiliate of a Party.

 

" Third Party Claims " shall have the meaning set forth in the License Agreement.

 

" Trademark " shall mean any word, name, symbol, color, designation or devise or any combination thereof, including ay trademark, trade dress, brand mark, service mark, trade name, brand name, logo or business symbol, whether or not registered.

 

" Unit " shall mean a unit of Product in Final Packaged Form supplied by Allergan to Licensee in accordance with the terms of this Agreement.

 

" U.S. " shall mean the United States of America, its territories and possessions.

 

ARTICLE II

 

MANUFACTURE AND SUPPLY OF PRODUCT

 

2.1           Engagement .

 

(a)          Subject to the terms and conditions set forth herein, Licensee hereby agrees to purchase, and Allergan hereby agrees to Manufacture or have Manufactured, supply and sell to Licensee, during the Term, for sale solely in the Field and solely in the Territory, the Product ordered by Licensee pursuant to the terms of this Agreement. Allergan may delegate all or any portion of its obligations hereunder to any Affiliate or Subcontractor; provided, that Allergan shall remain fully liable pursuant to this Agreement despite any such delegation.

 

(b)          Licensee shall be obligated to purchase all requirements of it, its Affiliates and permitted Sublicensees for the Product from Allergan under this Agreement.

 

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(c)          Notwithstanding anything herein or in the License Agreement to the contrary, the Parties agree that Allergan may Manufacture or have Manufactured the Product anywhere in the world for Commercialization outside the Territory.

 

2.2           Representations and Warranties .

 

(a)           Representations and Warranties of Allergan . Allergan warrants that the Product supplied by Allergan to Licensee hereunder and the Manufacturing of the Product by Allergan, its Affiliates and/or Subcontractors, as applicable, shall comply with the Specifications, cGMP and applicable Laws.

 

(b)           No Implied Representations or Warranties . OTHER THAN AS EXPRESSLY SET FORTH IN THIS SECTION 2.2 AND SECTIONS 9.1, 9.2 AND 9.3 OF THE LICENSE AGREEMENT, NEITHER PARTY MAKES OR GIVES ANY REPRESENTATIONS OR WARRANTIES UNDER OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY WHATSOEVER, AND EXPRESSLY DISCLAIMS ALL OTHER REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS, IMPLIED, OR STATUTORY, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND WARRANTIES ARISING FROM COURSE OF DEALING OR USAGE OF TRADE.

 

2.3           Packaging . With respect to each country in the Territory, Allergan (or Licensee if Licensee is the holder of the Regulatory Approval in such country in accordance with the License Agreement) shall be responsible for the design and delivery of the artwork, logo, Trademarks, package inserts, package leaflets, external packaging and other information (collectively, the " Packaging Information ") for the Product in Final Packaged Form and will provide all necessary labeling for sale of the Product in such country in accordance with applicable Regulatory Approvals. The Packaging Information shall comply in all respects with all applicable Laws.

 

2.4           Limitations . Notwithstanding any other provision of this Agreement, all Product supplied by Allergan to Licensee hereunder is solely and exclusively for sale in accordance with applicable Laws in the Field in the Territory in accordance with the License Agreement and may not be sold, directly or indirectly, outside the Territory or used for any other purpose.

 

ARTICLE III

 

ORDER QUANTITIES, FORECASTING AND ORDERING

 

3.1           Monthly Forecast .

 

(a)           Product Forecast . Beginning on the Effective Date and thereafter on or before [...***...] of each calendar month, Licensee shall submit to Allergan a [...***...] rolling forecast that sets forth the total quantity of Products that Licensee either has ordered or expects to order from Allergan within the next [...***...] month period (" Product Forecast "). For the avoidance of doubt, the Product Forecast shall not include the calendar month during which the Product Forecast is provided.

 

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(b)           Firm Orders . The forecast for the [...***...] calendar months (the " Binding Period ") in each Product Forecast shall include the requested delivery dates during the Binding Period and shall be treated as firm orders binding upon the Parties (" Firm Orders ").

 

(c)           Semi-Binding Forecasts . The forecast for the [...***...] calendar months (the " Semi-Binding Period ") in each Product Forecast shall include the requested delivery dates during the Semi-Binding Period (" Semi-Binding Forecast "). Licensee may revise the quantity stated in and the timing of a Semi-Binding Forecast in subsequent Product Forecasts, provided, that such revision to a Semi-Binding Forecast for a given calendar month (whether increase or reduction) may not in any circumstances exceed [...***...] (" Agreed Tolerance ") from the quantity first specified in a Semi-Binding Forecast for such calendar month.

 

(d)           Non-Binding Forecasts . The forecast for the [...***...] in each Product Forecast are non-binding orders (" Planned Orders "), but orders which Licensee reasonably believes are likely over time to become Firm Orders.

 

3.2           Information for Long-Term Planning . By [...***...] in each Calendar Year, Licensee shall submit to Allergan a non-binding estimate of its requirements for the Product on a country-by-country regional basis for the following regions: Europe (including Switzerland), Canada and the Middle East. Such estimate shall cover the following [...***...] Calendar Years (including the Calendar Year in which such estimate is submitted) or the remaining portion of this Agreement, whichever is shorter. This information is for informational and planning purposes only and will not amend any Product Forecast or Purchase Order then in effect.

 

3.3           Amending Forecasts .

 

(a)           Non-Binding Forecasts . Planned Orders are to be considered to be estimated forecasts for planning purposes only and shall not be construed as a firm commitment by Allergan to Licensee. Planned Orders may be reasonably increased or reduced by Licensee from time to time.

 

(b)           Semi-Binding Forecasts . Quantities forecast in a Semi-Binding Forecast may not be (i) reduced or increased by more than the Agreed Tolerance or (ii) accelerated or delayed without the written consent of Allergan.

 

(c)           Firm Orders . A Firm Order cannot be reduced, accelerated, delayed, or increased by Licensee without the written consent of Allergan.

 

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3.4           Purchase Orders . Licensee shall, together with each Product Forecast, deliver to Allergan a written purchase order (" Purchase Order ") in respect of each Firm Order for which Licensee has not previously submitted a Purchase Order. Licensee will accompany such Product Forecast with a new Purchase Order for each new Firm Order that was previously included in a Semi-Binding Forecast. Each Purchase Order shall specify the quantities of the Product ordered and the delivery date consistent with the applicable Firm Order.

 

3.5           Order Size . Each Purchase Order shall specify a minimum order quantity of [...***...] vials of Product and a minimum of [...***...] vials per SKU with an average for each Purchase Order of [...***...] vials per SKU or greater. For purposes of this Section 3.5, " SKU " shall mean Product intended for sale in one country or a group of countries in which the Product may be sold using the same Packaging Information. Allergan has the right not to fulfill any Purchase Order which does not conform to the requirements of this Section 3.5 . Delivery by Allergan of the requested quantity ordered by Licensee within a deviation of plus or minus [...***...] shall constitute full satisfaction of the applicable order.

 

3.6           Allergan's Fulfillment of Purchase Orders . Allergan shall use Commercially Reasonable Efforts to satisfy Licensee's Purchase Orders in accordance with their terms.

 

3.7           Minimum Shelf Life . The Product supplied by Allergan to Licensee hereunder shall, as of the time that the Product is delivered to Licensee, have a minimum Shelf Life of [...***...].

 

ARTICLE IV

 

DELIVERY; INVOICES

 

4.1           Delivery . All deliveries of the Product shall be in Final Packaged Form and shall be made by Allergan [...***...] (INCOTERMS 2010) the Facilities (the " Delivery Location "). Title and risk of loss will shift to Licensee upon delivery to the common carrier at the Facilities for shipment to Licensee's warehouse located at [...***...], or such other locations as may be designated by Licensee to Allergan from time to time at least [...***...] prior to the requested delivery date. Licensee will then be responsible for coordinating and executing all logistics and documentation for Product shipping.

 

4.2           Certificates . Allergan shall provide to Licensee, in preparation for each delivery of the Products, a " Certificate of Analysis " and a " Certificate of Conformance " as specified in the Quality Agreement for each batch of Products delivered.

 

4.3           Certificate of Origin . Allergan shall, for customs purposes, upon delivery of the Products, provide Licensee with a valid declaration of origin, in a form reasonably acceptable to Licensee, in respect of all Products supplied to Licensee under this Agreement, together with such other supporting documents relating to the origin of such Products as Licensee may reasonably require.

 

4.4           Method of Invoicing . All orders under this Agreement shall be invoiced at the time of shipment.

 

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ARTICLE V

 

QUALITY ASSURANCE, PHARMACOVIGILANCE AND CHANGE MANAGEMENT

 

5.1           Pharmacovigilance Agreement; Quality Agreement .

 

(a)          Within [...***...] after the Effective Date, the Parties shall in good faith negotiate and execute a mutually acceptable Pharmacovigilance Agreement (" Pharmacovigilance Agreement ") addressing drug safety and adverse event reporting and compliance.

 

(b)          Within [...***...] after the Effective Date, the Parties shall in good faith negotiate and execute a mutually acceptable Quality Agreement (" Quality Agreement "), which addresses the management of the quality elements related to the Product.

 

(c)          Except with respect to quality-related matters for which the Quality Agreement shall prevail, in the event of any conflict between the terms of this Agreement and the Quality Agreement or the Pharmacovigilance Agreement, this Agreement shall prevail.

 

5.2           Rejected Product . Licensee shall use Commercially Reasonable Efforts to visually inspect each shipment of Product delivered to it hereunder for visible damage.

 

(a)          Licensee shall promptly notify Allergan in writing within [...***...] after receipt of any Non-Conforming Product (the " Rejected Product ").

 

(b)          If no notification is made as stated in clause (a) above, Licensee will be deemed to have accepted any delivered Product.

 

(c)          At Allergan's direction, Licensee shall destroy the Non-Conforming Product and deliver to Allergan a certified destruction report of the Rejected Product or return the Non-Conforming Product to Allergan in accordance with applicable Laws.

 

5.3           Disputed Product . If Allergan disputes a rejection of Product by Licensee (the " Disputed Product "), it shall provide notice of such dispute to Licensee no later than [...***...] after receipt of notice of rejection from Licensee in accordance with Section 5.2 . In such event, an independent laboratory which is acceptable to both Parties will be engaged to test the Disputed Product. If such laboratory determines that the Disputed Product does not contain any Non-Conformity, Licensee will pay the fees of such laboratory related to such testing and validation of testing and will promptly pay for the Disputed Product, and such Disputed Product shall constitute Product supplied to Licensee pursuant to this Agreement. If such laboratory finds that the Disputed Product is Non-Conforming, Allergan will pay the fees of such laboratory related to such testing and validation of testing. Both Parties agree to accept and be bound by the findings of such independent laboratory.

 

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5.4           Remedies for Non-Conforming Product . Allergan shall, at Licensee's election and as its sole remedy, either (x) replace any Rejected Product or any Disputed Product that has been found to be Non-Conforming in accordance with Section 5.3 as soon as reasonably practicable, at no cost to Licensee, and Allergan shall notify Licensee of the expected date of delivery of such replacement Product, or (y) refund to Licensee the price paid for such Rejected Product or Disputed Product that has been found to be Non-Conforming in accordance with Section 5.3, plus any applicable delivery charge.

 

5.5           Change Management .

 

(a)          For changes to the Product that are required by applicable Laws including any requirement of a Regulatory Authority, or for safety considerations exclusively applicable to the Manufacture of the Product (" Required Changes "), the Parties shall cooperate in making such Required Changes promptly. If the Required Change is required only for the Territory, the reasonable and documented costs (including such costs incurred by any Subcontractors) of implementing such Required Change shall be borne by Licensee; otherwise, Licensee shall pay its pro rata portion, based on the prior year sales of the Product in the Territory relative to global sales of the Product, as a result of a Required Change and Allergan shall pay the balance.

 

(b)          If Allergan wishes to make a change with respect to the Product that is not a Required Change (a " Discretionary Change "), including a change related to a Facility where the Product is currently Manufactured, Allergan shall provide notice of such change as early as possible and the Parties shall discuss such Discretionary Change and Allergan shall be entitled to make such Discretionary Change and shall bear all costs of its implementation; provided, that such costs shall constitute Allergan Cost of Goods Sold.

 

(c)          If Licensee wishes Allergan to make a Discretionary Change with respect to the Product, the Parties shall discuss such Discretionary Change and, subject to Allergan's prior written consent (not to be unreasonably withheld, delayed or conditioned), Allergan shall implement such Discretionary Change. Licensee shall bear all costs incurred by Allergan or its Affiliates or Subcontractors in connection with the implementation of such Discretionary Change. Payment for such costs shall be made by Licensee within [...***...] of receipt of an invoice therefor, together with reasonably detailed supporting documentation.

 

5.6           Product Recalls . Either Party shall have the discretion to make a decision for recalling, or issuing an advisory letter or other safety-related communication with respect to, the Product in the Territory, and shall notify the other Party in a timely manner in connection with any such action; provided, however, that in all cases Licensee shall be responsible for carrying out such recall or other action. Any costs associated with such action shall be the responsibility of (i) Allergan, in the event such action is the direct result of a Non-Conformity, is required by a Regulatory Authority or is a discretionary recall as determined by Allergan, and (ii) Licensee, in all other cases. Each Party agrees to provide reasonable assistance to the other Party in the event of any recall or issuance of any advisory letter. If Licensee becomes aware of any information that reasonably suggests that the Product may have caused or contributed to a death or serious injury, or that the Product has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, Licensee agrees to have in place the necessary procedures and personnel training for Licensee (a) to furnish such information to Allergan within twenty-four (24) hours of Licensee's receipt of the same and (b) to make and retain records of such information. Licensee agrees to use its best efforts to investigate the information as requested by Allergan and furnish to Allergan such information in writing. In order to address such an event, Licensee shall maintain a current list of all customers who have ordered the Product and in what amounts, which list shall include lot numbers and any other information reasonably necessary to track each unit of Product sold by Licensee to a customer in the Territory.

 

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ARTICLE VI

 

PRICE, PAYMENTS AND REPORTING

 

6.1           Price; Payments .

 

(a)          The price per Unit purchased and supplied pursuant to this Agreement shall be equal to [...***...] as set forth in the applicable invoice (the " Purchase Price ").

 

(b)          Payments due by Licensee to Allergan pursuant to this Agreement shall be due and payable within [...***...] after receipt of the relevant invoice by Licensee.

 

(c)          All sums due under this Agreement shall be payable in [...***...] by bank wire transfer in immediately available funds to such bank account as Allergan shall designate. Licensee shall be liable to pay interest to Allergan on all overdue amounts from the due date until the date the overdue outstanding amount is paid at the [...***...] for the [...***...] plus [...***...], but in no event higher than the highest rate permissible under applicable Law.

 

6.2           Distribution Costs; Transfer and Other Taxes and Fees . Licensee shall be responsible for payment of (i) all shipping, freight, distribution and similar costs or expenses incurred following delivery of the Product at the Delivery Location and (ii) any import, export or other fees or taxes incurred by Allergan in connection with the supply of Product to Licensee hereunder.

 

6.3           Audit Rights . Each Party shall have the right to appoint a nationally recognized independent Third Party accounting firm (the " Auditor ") to audit the books and records of the other Party and its Affiliates to verify the accuracy of the reports, statements, books of accounts and payments made hereunder, as applicable. Such audit shall be conducted upon at least [...***...] advance written notice, during normal business hours, and shall commence on a date reasonably acceptable to both Parties. The Auditor may not reveal information learned in the course of such audit other than the amount of discrepancies in payments subject to audit under this Agreement. The Auditor will prepare and provide to each Party a written report stating whether the reports submitted and amounts paid are correct or incorrect and the amounts of any discrepancies, as well as any findings of noncompliance. Such audit shall not be more frequent than [...***...] per Calendar Year. The Auditor shall be required to sign a confidentiality agreement for the benefit of, and in a form reasonably acceptable to, Licensee and Allergan. Any overpayment or underpayment revealed by an audit shall be paid by the applicable Party to the other Party within [...***...] of it being disclosed. If an audit demonstrates a discrepancy of more than [...***...] of the payment due during the audited period, the audited Party shall be liable for the reasonable cost of the audit that discovered such discrepancy. Otherwise, the auditing Party shall bear the costs of such audits.

 

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ARTICLE VII

 

TERM AND TERMINATION

 

7.1           Term . The term of this Agreement shall be co-terminous with the term of the License Agreement and this Agreement shall automatically extend, expire or terminate, as applicable, concurrently with the extension, expiration or termination of the License Agreement.

 

7.2           Effect of Expiration and Termination .

 

(a)          Upon termination of this Agreement, Allergan will be entitled, at its option, to fill (or partially fill) or cancel any Purchase Orders that were submitted by Licensee or its Affiliates prior to such termination. If Allergan elects to fill (or partially fill) any such Purchase Orders, Allergan shall use Commercially Reasonable Efforts to fill (or partially fill) any such Purchase Orders. If Allergan elects not to fill (or partially fill) any such Purchase Orders, Licensee shall reimburse Allergan for the costs (including raw material costs) incurred in connection with Purchase Orders that Allergan had started to Manufacture prior to the expiration or termination of this Agreement and that are canceled by Allergan pursuant to this Section 7.2(a) .

 

(b)          The termination or expiration of this Agreement for any reason will not release either Party from the obligation to pay any sum that may be owing to the other Party (whether then or thereafter due) or operate to discharge any liability or obligation that had been incurred by either Party prior to any such termination.

 

(c)          The following Articles and Sections of this Agreement shall survive any expiration or termination of this Agreement for any reason: Section 1.1 (to the extent necessary to give effect to the Articles and Sections enumerated in this Section 7.2(c)), Sections 5.2, 5.3 and 5.4 (to the extent necessary to finally resolve issues with respect to any Rejected Product or Disputed Product), this Section 7.2 and Articles VIII and IX .

 

ARTICLE VIII

 

INDEMNIFICATION

 

8.1           Indemnification by Licensee . Licensee shall indemnify, hold harmless, and defend Allergan, its Affiliates, and their respective directors, officers, employees and agents (" Allergan Indemnitees ") from and against Damages brought or Claimed by or on behalf of any Third Party (other than a Allergan Indemnitee) to the extent arising out of or resulting from, directly or indirectly, (a) any breach of this Agreement by Licensee Indemnitees; (b) the negligence or willful misconduct by or of Licensee Indemnitees; and (c) any failure of Licensee Indemnitees to comply with any applicable Laws in connection with performing its obligations under this Agreement, except, in each case of clauses (a), (b), or (c) above, to the extent that any such Damages arise from any activity set forth in Sections 8.2(a), 8.2(b), or 8.2(c) for which Allergan is obligated to indemnify Licensee Indemnitees.

 

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8.2           Indemnification by Allergan . Allergan shall indemnify, hold harmless, and defend Licensee, its Affiliates, and their respective directors, officers, employees and agents (" Licensee Indemnitees ") from and against Damages brought or Claimed by or on behalf of any Third Party (other than a Licensee Indemnitee) to the extent arising out of or resulting from, directly or indirectly, (a) any breach of this Agreement by Allergan Indemnitees; (b) the negligence or willful misconduct by or of Allergan Indemnitees; (c) any failure of Allergan Indemnitees to comply with any applicable Laws in connection with performing its obligations under this Agreement, except, in each case of clauses (a), (b), or (c) above, to the extent that any such Damages arise from any activity set forth in Sections 8.1(a), 8.1(b), or 8.1(c) or for which Licensee is obligated to indemnify Allergan Indemnitees.

 

8.3           Indemnification Procedures . In the event of any such Claim against any Licensee Indemnitee or Allergan Indemnitee (individually, an " Indemnitee "), the indemnified party shall promptly notify the other party in writing of the Claim for which indemnification is sought under this Article VIII; provided, that, failure to promptly notify the indemnifying party shall relieve the indemnifying party of any obligation to the indemnified party under this Section 8.3 solely to the extent prejudicial to the indemnifying party's ability to defend such action. The indemnifying party shall, at its sole expense, defend and control such Claim with counsel of its own choosing; provided, however, that the indemnified party may participate in the defense of such Claim with its own counsel and at its own expense. The indemnified party shall, and shall cause its Indemnitees to, fully cooperate with the indemnifying party in the investigation or defense of any Damages or Third Party Claim covered by this Article VIII. The Indemnitees shall not settle such Claim without the indemnifying party's prior written consent. The indemnifying party shall not settle such Claim without the prior written consent of the Indemnitees against which such Claim was brought, which consent shall not be unreasonably withheld, conditioned or delayed.

 

8.4           Apportionment . In the event a Claim is based partially on an indemnified Claim described in Section 8.1 or Section 8.2 above and partially on a non-indemnified Claim, or is based partially on a Claim indemnified by one Party and partially on a claim indemnified by the other Party pursuant to Section 8.1 or Section 8.2 above, any payments and reasonable attorney fees incurred in connection with such claims are to be apportioned between the Parties in accordance with the degree of cause attributed to each Party.

 

8.5           Limitation of Liability . NEITHER PARTY SHALL BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES, INCLUDING LOST PROFITS, ARISING FROM OR RELATING TO THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 8.5 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER THIS AGREEMENT, OR THE RIGHTS OR OBLIGATIONS OF EITHER PARTY WITH RESPECT TO (A) THE INFRINGEMENT OR MISAPPROPRIATION OF THE OTHER PARTY'S INTELLECTUAL PROPERTY RIGHTS OR (B) UNAUTHORIZED USE OR DISCLOSURE OF THE OTHER PARTY'S CONFIDENTIAL INFORMATION.

 

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8.6           Liability Cap . NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN, THE TOTAL AND AGGREGATE LIABILITY OF ALLERGAN (AND ITS AFFILIATES) ARISING OUT OF, OR OTHERWISE IN CONNECTION WITH, THIS AGREEMENT (INCLUDING, FOR CLARITY, THE PHARMACOVIGILANCE AGREEMENT AND THE QUALITY AGREEMENT) (INCLUDING BREACH OF CONTRACT, TORT, INDEMNITY OR OTHERWISE) SHALL NOT EXCEED THE AGGREGATE PURCHASE PRICE RECEIVED BY ALLERGAN WITH RESPECT TO THE PRODUCT IN THE CALENDAR YEAR IN WHICH THE APPLICABLE CLAIM IS MADE.

 

ARTICLE IX

 

MISCELLANEOUS

 

9.1           Relationship of the Parties . Each Party shall bear its own costs incurred in the performance of its obligations hereunder without charge or expense to the other except as expressly provided in this Agreement. Neither Party shall have any responsibility for the hiring, termination or compensation of the other Party's employees or for any employee benefits of such employees. No employee or representative of a Party shall have any authority to bind or obligate the other Party to this Agreement for any sum or in any manner whatsoever, or to create or impose any contractual or other liability on the other Party without said Party's approval. For all purposes, and notwithstanding any other provision of this Agreement to the contrary, Licensee's legal relationship under this Agreement to Allergan shall be that of independent contractor. Nothing in this Agreement shall be construed to establish a relationship of co-partners or joint venturers between the Parties.

 

9.2           Registration and Filing of this Agreement . To the extent, if any, that either Party has reason to conclude that it is required to file or register this Agreement or a notification thereof with any Governmental Authority, including the U.S. Securities and Exchange Commission, the Competition Directorate of the Commission of the European Communities or the U.S. Federal Trade Commission, in accordance with applicable Law, such Party shall inform the other Party thereof and both Parties shall cooperate each at its own expense in such filing or notification and shall execute all documents reasonably required in connection therewith; provided, that such filing Party shall deliver a draft of the document(s), in redacted form or otherwise as such document(s) are proposed to be filed pursuant to this Section 9.2, to the other Party at least [...***...] prior to the required filing date and such filing Party shall implement any and all further redactions or modifications reasonably requested by the other Party. In such filing or registration, the Parties shall request confidential treatment of sensitive provisions of this Agreement, to the extent permitted by applicable Law. The Parties shall promptly inform each other as to the activities or inquiries of any such Governmental Authority relating to this Agreement, and shall cooperate to respond to any request for further information therefrom on a timely basis, provided, that any further document(s) provided to any such Government Authority will be subject to the requirements of this Section 9.2.

 

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9.3           Force Majeure . The occurrence of an event that materially interferes with the ability of a Party to perform its obligations or duties hereunder which is not within the reasonable control of the Party affected, not due to such Party's malfeasance, and which could not with the exercise of due diligence have been avoided (each, a " Force Majeure "), including an injunction, order or action by a Governmental Authority, fire, accident, labor difficulty, strike, riot, civil commotion, act of God, delay or errors by shipping companies or change in applicable Law, shall not excuse such Party from the performance of its obligations or duties under this Agreement, but shall merely suspend such performance during the continuation of Force Majeure. The Party prevented from performing its obligations or duties because of Force Majeure shall promptly notify the other Party hereto of the occurrence and particulars of such Force Majeure and shall provide the other Party, from time to time, with its best estimate of the duration of such Force Majeure and with notice of the termination thereof. The Party so affected shall use reasonable efforts to avoid or remove such causes of nonperformance. Upon termination of Force Majeure, the performance of any suspended obligation or duty shall promptly recommence.

 

9.4           Choice of Law . All disputes, claims or controversies arising out of, relating to or in connection with this Agreement, including any question regarding its formation, existence, validity, enforceability, performance, interpretation or termination, shall be governed by the laws of the State of New York, USA (without reference to its choice of law or conflicts of law rules).

 

9.5           Dispute Resolution . The provisions of Section 15.5 of the License Agreement are incorporated herein by reference.

 

9.6           Remedies Cumulative . The remedies set forth in this Agreement (including termination rights) are cumulative and shall not be construed to restrict or otherwise affect any other remedies that may be available under any other agreement or under applicable Law.

 

9.7           Assignment . This Agreement may not be assigned by either Party without the prior consent of the other Party; provided, however, that each Party shall have the right to assign its rights and obligations under this Agreement to any Third Party successor to all or substantially all of its entire business with written notice to the other Party. It is further understood and agreed that each Party may assign, or otherwise cause to be performed, its obligations under this Agreement (including obligations of confidentiality, processing and payment) to or by, as the case may be, one or more of its Affiliates. This Agreement shall be binding upon, and subject to the terms of the foregoing sentence, inure to the benefit of the Parties hereto, their successors, legal representatives and assigns.

 

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9.8           Notices . All demands, notices, consents, approvals, reports, requests and other communications hereunder must be in writing and will be deemed to have been duly given only if delivered personally, by certified or registered mail, return receipt requested, or by overnight delivery using a globally-recognized carrier, to the Parties at the following addresses or facsimile numbers:

 

Allergan: Durata Therapeutics International B.V.
  Barbara Strozzilaan 101
  Spaces Zuida,
  Amsterdam, The Netherlands
  Attention: General Manager
   
With copy to: Allergan plc
  Morris Corporate Center III
  400 Interpace Parkway
  Parsippany, NJ 07054
  United States
  Facsimile No.: [...***...]
  Attention: Chief Legal Officer
   
Licensee: General Counsel
  Correvio International Sárl
  Rue des Alpes 21
  Case Postale 1674
  1201 Geneva Switzerland
  Facsimile No.: +41 (0) 22 907 79 71
   
With copy to: General Counsel
  Cardiome Pharma Corp.
  1441 Creekside Drive, 6th Floor
  Vancouver, BC V6J 4S7
  Canada
  Facsimile No.: +1 604 677 6915

 

or to such other address as the addressee shall have last furnished in writing in accord with this provision to the addressor. All notices shall be deemed effective upon receipt by the addressee.

 

9.9           Invalid Provisions . If any provision of this Agreement is held to be illegal, invalid or unenforceable under any applicable present or future Law, then such provision will be fully severable, and the remaining provisions of this Agreement will remain in full force and effect and will not be affected by the provision or by its severance herefrom.

 

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9.10          Headings . The headings used in this Agreement have been inserted for convenience of reference only and do not define or limit the provisions hereof.

 

9.11          Interpretation . Unless the context of this Agreement otherwise requires: (a) words of any gender include each other gender; (b) words using the singular or plural number also include the plural or singular number, respectively; (c) the terms "hereof," "herein," "hereby," and derivative or similar words refer to this entire Agreement; (d) the terms "Article," "Section" or "Exhibit" refer to the specified Article, Section or Exhibit of this Agreement; (e) the term "including" means "including without limitation"; and (f) "days" refers to calendar days. All accounting terms used but not otherwise defined herein have the meanings ascribed to such terms under the applicable accounting standards as applied to a Party. All references to " $ " amounts hereunder shall be deemed to be U.S. Dollars, and all payments due hereunder shall be made in U.S. Dollars unless otherwise specified.

 

9.12          Waiver . Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. No waiver by any Party of any term or condition of this Agreement, in any one or more instances, shall be deemed to be or construed as a waiver of the same or any other term or condition of this Agreement on any future occasion. The failure of either Party at any time or times to require performance of any provision hereof shall in no manner affect its rights at a later time to enforce the same.

 

9.13          Entire Agreement; Amendments . This Agreement (including the exhibits and schedules hereto) together with the Ancillary Agreements (as defined in the License Agreement) constitute the entire agreement between the Parties hereto with respect to the within subject matter and supersedes all previous agreements and understandings between the Parties, whether written or oral. This Agreement may be altered, amended or changed only by a writing making specific reference to this Agreement and signed by duly authorized representatives of Allergan and Licensee.

 

9.14          No License . Nothing in this Agreement shall be deemed to constitute the grant of any license or other right in either Party to or in respect of any product, patent, Trademark, Confidential Information, trade secret or other data or any other Intellectual Property of the other Party, each as defined in the License Agreement, except as expressly set forth herein.

 

9.15          Third Party Beneficiaries . None of the provisions of this Agreement shall be for the benefit of or enforceable by any Third Party, including any creditor of either Party hereto. No such Third Party shall obtain any right under any provision of this Agreement or shall by reasons of any such provision make any Claim in respect of any debt, liability or obligation (or otherwise) against either Party hereto.

 

9.16          Counterparts . This Agreement may be executed in any two or more counterparts, each of which, when executed, shall be deemed to be an original and all of which together shall constitute one and the same document.

 

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9.17          Compliance with Law . Notwithstanding any other provision of this Agreement, neither Party shall be required to undertake any activity or obligation under this Agreement which it has a reasonable belief may violate any applicable Laws; provided, however, a Party which so believes shall promptly inform the other Party of such belief.

 

9.18          Forms . The Parties recognize that, during the Term, a Purchase Order, acknowledgement form or similar routine document (collectively " Forms ") may be used to implement or administer provisions of this Agreement. Therefore, the Parties agree that the terms of this Agreement will prevail in the event of any conflict between this Agreement and the printed provision of such Forms, or typed provisions of Forms that add to, vary, modify or are at conflict with the provisions of this Agreement with respect to the Product sold hereunder during the Term.

 

9.19          Independent Contractors . It is understood that both Parties are independent contractors and are engaged in the operation of their own respective businesses. Neither Party is the agent of the other for any purpose whatsoever, and neither Party has any authority, express or implied, to enter into any contracts or assume any obligations for the other, to pledge the credit of the other or make any warranties or representations on behalf of the other, except where expressly authorized in writing to do so. Nothing in this Agreement or in the activities of either Party shall be deemed to create an agency, partnership or joint venture relationship.

 

9.20          Confidentiality . Each Party hereto acknowledges that the information being provided to it in connection with this Agreement and the transactions contemplated hereby is subject to Article VIII of the License Agreement, the terms of which are incorporated herein by reference.

 

THE BALANCE OF THIS PAGE IS LEFT BLANK INTENTIONALLY

 

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IN WITNESS WHEREOF , Allergan and Licensee, by their duly authorized officers, have executed this Agreement as of the date first written above.

 

DURATA THERAPEUTICS INTERNATIONAL B.V.   CORREVIO INTERNATIONAL SARL
         
By:     By:  
Name: Maurice Mulders   Name:  
Title: Director   Title:  
         
By:     By:  
Name: Jan Peters   Name:  
Title: Director   Title:  

  

[Signature Page to Supply Agreement]

 

 

 

Exhibit 4.5

 

CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
[…***…] 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

 

Exclusive License and Supply Agreement

 

by and between

 

Cardiome Pharma Corp. and Correvio International Sárl

 

and

 

SteadyMed Ltd.

 

 

CONFIDENTIAL

 

TABLE OF CONTENTS

 

Article 1 DEFINITIONS 1
   
Article 2 LICENSE 13
   
Article 3 JOINT STEERING COMMITTEE 18
   
Article 4 MANUFACTURING AND SUPPLY 20
   
Article 5 REGULATORY MATTERS 26
   
Article 6 COMMERCIALIZATION 30
   
Article 7 FINANCIAL TERMS OF LICENSE 35
   
Article 8 PAYMENTS; RECORDS; AUDITS 36
   
Article 9 BUSINESS ETHICS 39
   
Article 10 CONFIDENTIALITY 39
   
Article 11 INTELLECTUAL PROPERTY 42
   
Article 12 WARRANTIES; INDEMNITIES; INSURANCE 47
   
Article 13 INDEMNIFICATION; INSURANCE 51
   
Article 14 TERM AND TERMINATION 53
   
Article 15 MISCELLANEOUS 57

 

Schedule 1.6 (a)  
   
Schedule 1.6 (b)  
   
Schedule 1.34  
   
Schedule 1.107  
   
Schedule 10.5  

 

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Exclusive License and Supply Agreement

 

This Exclusive License and Supply Agreement (this “ Agreement ”) is made as of 28th June 2015 (the “ Effective Date ”), by and between Cardiome Pharma Corp. , a company duly incorporated under the laws of Canada, with its principal place of business at 1441 Creekside Drive, 6th Floor, Vancouver BC V6J 4S7 and Correvio International Sàrl, a company duly incorporated and existing under the laws of Switzerland, with its principal place of business at Rue des Alpes 21, 1201 Geneva, Switzerland (hereinafter collectively referred to as “ Cardiome ”), and SteadyMed Ltd. , a company organized and existing under the laws of Israel with its principal place of business at 5 Oppenheimer Street, Rehovot 7670105, Israel (“ SteadyMed ”). Each of Cardiome and SteadyMed is referred to individually as a “ Party ” and collectively as the “ Parties ”.

 

WITNESSETH:

 

WHEREAS, Cardiome manufactures and markets several pharmaceutical products worldwide;

 

WHEREAS, SteadyMed is engaged in the development of its Trevyent® (Patch Pump® enabled treprostinil) therapeutic candidate for the treatment of pulmonary arterial hypertension (the “Product”, as defined in more detail below) and is the owner of patent rights and other intellectual property related thereto; and

 

WHEREAS, Cardiome desires to obtain from SteadyMed an exclusive license to register and market the Product in certain regions outside the United States of America and to have SteadyMed supply Cardiome’s requirements of the Product for such purpose, and SteadyMed is willing to grant such license and supply such Product; in each case, on the terms and subject to the conditions set forth in this Agreement.

 

NOW, THEREFORE, in consideration of the foregoing premises, the Parties, intending to be legally bound, do hereby agree as follows:

 

Article 1

 

DEFINITIONS

 

The following terms shall have their indicated meanings when used in this Agreement:

 

1.1        “ Accounting Period ” means a Quarter or Year, as applicable.

 

1.2        “ Accounting Standards ” means U.S. generally accepted accounting standards consistently applied throughout the organization of a Party.

 

1.3        “ Affiliate ” means, with respect to a Party, any company or other business entity controlled by, controlling, or under common control with a Party hereto, for as long as such control exists. As used in this Section, “control” shall mean: (a) possession, directly or indirectly, of the power to direct the management and policies of such company or entity, whether through ownership of voting securities or by contract relating to voting rights or corporate governance; or (b) direct or indirect beneficial ownership of more than 50% (or such lesser percentage that is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) of the voting share capital in such company or entity.

 

 

CONFIDENTIAL

 

1.4        “ After-Acquired Third-Party IP ” means (a) any Patent of a Third Party with respect to which SteadyMed first acquires Control after the Effective Date and which would fall within the definition of Platform Patents or Product-Specific Patents, or (b) any Information of a Third Party with respect to which SteadyMed first acquires Control after the Effective Date and which would fall within the definition of SteadyMed Know-How; in each case, under an agreement that would obligate SteadyMed to pay royalties and/or milestone payments to such Third Party were Cardiome, its Affiliates, Sublicensees or Subdistributors to use or practice such After-Acquired Third Party IP in the use, sale, offer for sale, import or Commercialization of Product or Infusion set.

 

1.5        “ Anti-Corruption Laws ” means the U.S. Foreign Corrupt Practices Act, as amended, the UK Bribery Act 2010, as amended, the Organization for Economic Co-operation and Development (OECD) Convention on combating bribery of foreign public officials in international business transactions, and any other applicable anti-corruption laws.

 

1.6        “ Anti-Corruption Policy ” means (a) with respect to Cardiome, the Cardiome Pharma Corp. Code of Conduct, a copy of which, in its existing form as of the Effective Date, is attached hereto as Schedule 1.6 (a); and (b) with respect to SteadyMed, the SteadyMed Code of Conduct, a copy of which, in its existing form as of the Effective Date, is attached hereto as Schedule 1.6 (b). Upon either Party’s written request at any time and from time to time during the Term, the other Party shall promptly provide the requesting Party with a copy of its then-current Anti-Corruption Policy (if it differs in any material respect from Schedule 1.6 (a) or Schedule 1.6 (b), as applicable).

 

1.7        “ API ” means the active pharmaceutical ingredient known as treprostinil sodium [...***...].

 

1.8        “ Applicable Law ” means the applicable provisions of any and all laws, treaties, statutes, rules, regulations, administrative codes, guidance, ordinances, judgments, decrees, directives, injunctions, orders, permits (including Regulatory Approvals and Pricing Approvals) of or from any Governmental Agency having jurisdiction over or related to the subject item or subject person as they may be in effect from time to time.

 

1.9        “ Approved Labeling ” means the approved labeling for Product or Infusion set as set forth in the applicable Regulatory Approval in a particular jurisdiction.

 

1.10       “ Average Net Selling Price ” means, for a particular Supplied Item sold in a country of the Territory during a Quarter, the weighted (by unit sales volume) average net selling price per unit of such Supplied Item in cash-only, arm’s-length sales of such Supplied Item to Third Parties, when such Supplied Item is sold alone or only with other Supplied Item(s) (and, in each case, not with any product that is not a Supplied Item), in such country during such Quarter.

 

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1.11        “ Average Transfer Price ” means, for a particular Supplied Item sold by Cardiome, its Affiliates and Sublicensees in a country of the Territory during a Quarter, the weighted average Transfer Price (by SKU or concentration), determined in accordance with the first paragraph of Section 4.6(a) and without regard to Section 4.6(a)(ii) , of such Supplied Item for the total unit volume of such Supplied Item sold by Cardiome, its Affiliates and Sublicensees in the entire Territory during such Quarter, with such total unit volume determined in accordance with applicable Accounting Standards.

 

1.12        “ Bankruptcy Laws ” has the meaning provided in Section 15.10 .

 

1.13        “ Bright Stock ” has the meaning provided in Section 4.2 .

 

1.14        “ Cardiome House Marks ” means (i) the Cardiome trade name and logo, and (ii) any pending or future Trademark registrations, applications and unregistered Trademark rights, in each case, relating to the Cardiome trade name and/or logo.

 

1.15        “ Cardiome Margin ” means, for a particular Supplied Item sold by Cardiome or its Affiliates in a country of the Territory in a given Quarter, the quotient of the amount determined using the fraction A/B, where:

 

A = [...***...]; and

 

B = [...***...].

 

1.16        “ CFR ” means the United States Code of Federal Regulations.

 

1.17        “ COGS ” means SteadyMed’s fully-burdened aggregate cost of Manufacturing, or having Manufactured, a particular Supplied Item, determined and recorded in accordance with Accounting Standards, consistently applied throughout the SteadyMed organization for financial reporting purposes, calculated on a per-unit (by SKU) basis. Such costs include, without limitation: (a) in the case of a Supplied Item, raw materials, API, Drug Product, Devices, Device components or other materials supplied by a Third Party, the amounts paid by SteadyMed or its Affiliate to such Third Party for the applicable items (without mark-up of the Third Party’s invoice); (b) in the case of other Manufacturing activities performed by a Third Party, the amounts actually paid by SteadyMed or its Affiliate to such Third Party for performance of such activities (without mark-up of the Third Party’s invoice); (c) in the case of Manufacturing activities performed by SteadyMed or its Affiliate, SteadyMed’s or its Affiliate’s costs of performing such activities. For clarity, these costs include: (i) standard unit cost of such Supplied Item, consisting of direct materials, direct labor, and production overhead (including depreciation) directly attributable to such Supplied Item, at standard; and (ii) cost variances, consisting of direct materials variances, including material usage variances and purchase price variances, direct labor variances, and production overhead variances, including variable and fixed production overhead spending variances. In no circumstances, however, may the indirect overhead costs defined in (d) exceed [...***...], excluding such indirect overhead costs, and will be lowered based upon increased volume of purchases on a sliding scale (e.g., [...***...]. The JSC will discuss indirect overhead costs on an annual basis.

 

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1.18        “ Commercialization ” means marketing, Promoting, detailing, offering for sale, selling and distributing the Product or Infusion Set, as applicable, and other similar activities related to the commercial sale of the Product or Infusion Set, but excluding for clarity all activities relating to research, development or manufacturing of Product or Infusion Set. When used as a verb, “Commercializing” means engaging in Commercialization, and “Commercialize” and “Commercialized” shall have corresponding meanings.

 

1.19        “ Commercialization Standards ” has the meaning provided in Section 6.9(a) .

 

1.20        “ Commercially Reasonable Efforts ” means, with respect to a Party’s obligations under this Agreement to Manufacture, supply, register, Commercialize, or perform any other activity related to, Product, the level of reasonable, diligent, good faith efforts and resources that comparable companies (defined below) typically devote to products owned by them that are at a similar stage in their development or product life and are of similar market potential to the Product. As used in this Section, “comparable companies” shall mean companies in the pharmaceutical or biotechnology industry of a size and stage of development similar to that of such Party, including having human pharmaceutical product candidates or products in a similar stage of development or product life to the Product.

 

1.21        “ Competing Product ” means a pharmaceutical product for the treatment of pulmonary arterial hypertension.

 

1.22        “ Competitive Infringement ” of a SteadyMed Patent means any infringement of such SteadyMed Patent in a country of the Territory, wherein [...***...].

 

1.23        “ Confidential Information ” of a Party means any and all information or material (including, but not limited to, Information) that is disclosed, provided or made available by or on behalf of such Party (the “ Disclosing Party ”) or its Affiliates to the other Party (the “ Receiving Party ”) or its Affiliates, whether before or after the Effective Date, in connection with this Agreement or the transactions contemplated hereby; in each case, whether in oral, visual, electronic, written or other form. Without limiting the generality of the foregoing, Confidential Information of a Party shall include all “Confidential Information” (as such term is defined in the Confidentiality Agreement) disclosed, provided or made available by or on behalf of such Party or any of its Affiliates to the other Party or its Affiliates (or any of their respective Representatives) pursuant to the Confidentiality Agreement.

 

1.24        “ Confidentiality Agreement ” means the Confidentiality and Non-Disclosure Agreement between Cardiome Pharma Corp. and SteadyMed dated May 1, 2015.

 

1.25        “ Contract Manufacturer ” means:

 

(a)        the FP Manufacturer in the case of Finished Product; and

 

(b)        the FIS Manufacturer in the case of Finished IS.

 

1.26        “ Control ” or “ Controlled ” means, with respect to any Information, Patent or other intellectual property rights, possession by a Party of the ability (whether by ownership, license or otherwise) to grant access to, to grant use of, or to grant a license or a sublicense of or under such Information, Patents or intellectual property rights without violating the terms of any agreement or other arrangement with any Third Party.

 

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1.27        “ Copyrights ” means all copyrights, copyright registrations and applications therefor, and all other rights corresponding thereto throughout the world. For the avoidance of doubt, the term “Copyrights” excludes Patents, Information and Trademarks.

 

1.28        “ Defective Product ” has the meaning provided in Section 4.9(a) .

 

1.29        “ Delivery Date ” means, with respect to a Supplied Item Manufactured by or on behalf of SteadyMed for Cardiome hereunder and released by SteadyMed to Cardiome in accordance with the Quality Agreement, the date of delivery of such Supplied Item to Cardiome or its designated carrier at the applicable Manufacturing Facility.

 

1.30        “ Device ” means SteadyMed’s proprietary PatchPump® drug administration device for intravenous and subcutaneous delivery of drugs.

 

1.31        “ Disclosing Party ” has the meaning provided in Section 1.23 .

 

1.32        “ Drug Product ” means any formulation or presentation of the API, in any dosage strength or concentration, for intravenous and subcutaneous administration.

 

1.33        “ EMA ” means the European Medicines Agency and any successor agency thereto.

 

1.34        “ Europe ” means the states, territories and/or countries listed in Schedule 1.34 hereto.

 

1.35        “ Export Control Laws ” has the meaning provided in Section 2.7(a) .

 

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

 

1.37        “ FFDCA ” means the United States Federal Food, Drug, and Cosmetic Act, as amended.

 

1.38        “ Field ” means the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1).

 

1.39        “ Finished IS ” means a carton containing a specified number of Infusion Sets and the applicable Regulatory Authority-approved package insert (if any), packaged and labeled in final form as described in the applicable Regulatory Approval for Finished Product, suitable for commercial sale and distribution for use with Finished Product in the Field in the Territory.

 

1.40        “ Finished Product ” means a carton containing a Device pre-filled with a specified quantity of Drug Product and the applicable Regulatory Authority-approved package insert, packaged and labeled in final form as described in the applicable Regulatory Approval for Finished Product, suitable for commercial sale and distribution in the Field in the Territory.

 

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1.41        “ FIS Manufacturer ” means SteadyMed’s Finished IS contract manufacturer. As of the Effective Date, the FIS Manufacturer is Ypsomed AG.

 

1.42        “ FIS Manufacturing Facility ” means the FIS Manufacturer’s manufacturing facility for Finished IS located at Phillips-Medisize Corporation, Av. La Montãna, 76220 Santiago de Querétaro, Querétaro, Mexico.

 

1.43        “ Forecast ” has the meaning set forth in Section 4.5(b) .

 

1.44        “ FP Manufacturer ” means SteadyMed’s Finished Product contract manufacturer. As of the Effective Date, the FP Manufacturer is Bespak Europe Ltd.

 

1.45        “ FP Manufacturing Facility ” means the FP Manufacturer’s manufacturing facility for Finished Product located in Bergenway, King’s Lynn, Norfolk PE30 2JJ, United Kingdom

 

1.46        “ GMP ” means:

 

(a)        the current good manufacturing practices and standards for the production of drugs and finished pharmaceuticals, as set forth in 21 CFR Sections 210 and 211 and as interpreted by relevant ICH guidelines; in each case, as amended from time to time; and

 

(b)        the current good manufacturing practices and standards for the manufacture of medicinal products and active substances used as starting materials as set forth in the applicable European Community law and guidance, including the applicable good manufacturing practices set forth in European Community Directive 2003/94/EC, the Rules Governing Medicinal Products in the European Union, Volume 4 (Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice) and European Community Directive 2001/83/EC, all relevant implementations of such directives and relevant guidelines, as interpreted by relevant ICH guidelines; in each case, as amended from time to time.

 

1.47        “ Government Agency ” means any supranational, national, regional, state or local governmental agency, authority, department, bureau, commission, court, council, administrative body or other governmental entity, including, without limitation, any Regulatory Authority.

 

1.48        “ Government Official ” means any individual employed by or acting on behalf of a government, government- controlled entity or public international organization; any political party, party official or candidate; any individual who holds or performs the duties of an appointment, office or position created by custom or convention; or any individual who holds himself out to be the authorized intermediary of any of the foregoing.

 

1.49        “ ICH ” means the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

 

1.50        “ Improvement ” means any Invention that: (a) is made either (i) solely by one or more employees, consultants or contractors of Cardiome or any of its Affiliates, or (ii) jointly by one or more employees, consultants or contractors of Cardiome or any of its Affiliates and one or more employees, consultants or contractors of SteadyMed or any of its Affiliates; and (b) constitutes an improvement or modification to the Product or any of its components, including any new formulation, dosage, dosage form, delivery, method of use, indication or line extension of the Product or any component thereof.

 

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1.51        “ Information ” means tangible and intangible techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, know-how, skill, experience, test data and results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms, compositions of matter, and physical, biological or chemical material; that, in each case, are not in the public domain.

 

1.52        “ Infusion Set ” means SteadyMed’s medical device for use with the Product that connects the Device incorporated in the Product to the patient’s body, either subcutaneously or intravenously.

 

1.53        “ Initial Forecast ” has the meaning provided in Section 4.5(a) .

 

1.54        “ Initial Forecast Period ” means the period beginning on the Launch Date and ending on the last day of the fourth (4th) full Quarter following the Launch Date.

 

1.55        “ Initial Sales Force Training ” has the meaning provided in Section 6.10(a) .

 

1.56        “ Interested Persons ” has the meaning provided in Section 9.1 (d).

 

1.57        “ Invention ” means any invention or discovery, whether or not patentable, made in the course and as a result of the conduct of the activities contemplated by this Agreement.

 

1.58        “ Joint Steering Committee ” or “ JSC ” has the meaning set forth in Section 3.1 .

 

1.59        “ Latent Defect ” means a defect that causes a Supplied Item to fail to conform to the applicable Specifications, which defect is not discoverable upon reasonable physical inspection and testing performed pursuant to Section 4.9(a) but is discovered at a later time (e.g., in the course or as a result of long-term stability studies).

 

1.60        “ Launch Date ” means the date of the first sale of Finished Product by Cardiome or any of its Affiliates or Sublicensees to a Third Party (other than a Sublicensee) anywhere in the Territory following receipt of the first Regulatory Approval and Pricing Approval for Finished Product and/or finished Bright Stock in the jurisdiction of such sale.

 

1.61        “ Launch Period ” means the period beginning on the Launch Date and ending on the last day of the second full Quarter following the Launch Date.

 

1.62        “ LIBOR ” means the London Interbank Offered Rate for deposits in U.S. dollars having a maturity of one (1) month published by the British Bankers’ Association, as adjusted from time to time on the first (1st) London business day of each month.

 

1.63        “ Major Market ” means any of Canada, France, Germany, Italy and the United Kingdom.

 

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1.64        “ Manufacture ” (including, with correlative meanings, “Manufactured” and “Manufacturing”) means any steps, processes and activities necessary to produce Product, including without limitation, the manufacturing, processing, formulation, fill/finish, handling, labeling, packaging, inspection, quality control testing, release and storage of Product, and SteadyMed’s oversight of said steps, processes and activities.

 

1.65        “ Manufacturing Facility ” means:

 

(a)        the FP Manufacturing Facility in the case of Finished Product; and

 

(b)        the FIS Manufacturing Facility in the case of Finished IS.

 

1.66        “ Manufacturing Standards ” means GMP and/or QSR, as applicable to a particular Supplied Item.

 

1.67        “ Middle East ” means [...***...].

 

1.68        “ MSL ” means a medical science liaison for the Territory or any portion of the Territory.

 

1.69        “ Net Sales ” means the gross amounts invoiced by Cardiome and its Affiliates for sales of Supplied Item to Third Parties in the Territory, less the following deductions to the extent actually incurred, allowed, paid, taken, accrued or otherwise specifically attributable to sales of Supplied Item by the selling party:

 

(a)        refunds or credits actually given to purchasers for rejections or returns of Supplied Item, including for recalls, damaged goods and billing errors;

 

(b)        [...***...], to the extent separately set forth in the applicable invoice;

 

(c)        normal and customary quantity, trade and cash discounts actually allowed or taken with respect to sales of Supplied Items (to the extent not already reflected in the amount invoiced);

 

(d)        rebates (including pursuant to governmental regulation), charge-backs, retroactive price reductions, credits or allowances actually allowed or taken;

 

(e)        [...***...] to the extent separately itemized on the invoice [...***...]; and

 

(f)        [...***...].

 

In no event shall any particular amount of deduction identified above be deducted more than once in calculating Net Sales (i.e., no “double counting” of reductions). All discounts, allowances, credits, rebates, and other deductions shall be fairly and equitably allocated between Supplied Item and other products of Cardiome and its Affiliates and Sublicensees such that Supplied Item does not bear a disproportionate portion of such deductions. Sales of Supplied Item between Cardiome and any of its Affiliates or Sublicensees for resale shall be excluded from the computation of Net Sales, but the subsequent resale of Supplied Item to a Third Party shall be included within the computation of Net Sales. Supplied Item distributed as free promotional samples, donated for charitable purposes, or used in research, development or registration activities shall be disregarded in determining Net Sales.

 

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1.70        “ Non-Commercial Quantity ” has the meaning provided in Section 4.5(c) .

 

1.71        “ Non-Commercial Transfer Price ” has the meaning provided in Section 4.6(a)(i) .

 

1.72        “ Non-Commercial Unit ” means, with respect to a Supplied Item, a unit of such Supplied Item that is intended solely for distribution as a free promotional sample in the Territory or for use in analytical testing required by Regulatory Authorities in the Territory.

 

1.73        “ Official ” has the meaning provided in Section 12.1(e)(ii)(2) .

 

1.74        “ Other Drug ” means any active pharmaceutical ingredient other than treprostinil, or any drug substance or drug product other than treprostinil drug substance or treprostinil drug product.

 

1.75        “ PatchPump Mark ” means (i) the PatchPump® mark and (ii) any pending or future Trademark registrations, applications and unregistered Trademark rights, in each case, relating to the PatchPump® mark; but excluding, in each case, any SteadyMed House Mark.

 

1.76        “ Patents ” means (a) national, regional and international patents and patent applications filed in any country of the world, including, without limitation, provisional patent applications, (b) patent applications filed either from such patents and patent applications or from a patent application claiming priority from either of these, including any continuation, continuation-in-part, division, provisional, converted provisional and continued prosecution applications, or any substitute applications, (c) any patent issued with respect to or in the future issued from any such patent applications, including utility models, petty patents and design patents and certificates of invention, and (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, reexaminations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications.

 

1.77        “ Permitted Subdistributor ” has the meaning provided in Section 2.3(b) .

 

1.78        “ Person ” means any individual, organization or entity, including a government or political subdivision, department or agency of a government.

 

1.79        “ Platform Patents ” means Patents Controlled by SteadyMed during the Term that (a) claim any aspect of the SteadyMed Platform, any of its components, or any combination of two or more of its components, including, without limitation, the design, use, function, assembly and manufacture of any of the foregoing; and (b) in the absence of a license thereunder, would be infringed (if issued or granted) by the manufacture, use, sale, offer for sale or import of the Product.

 

1.80        “ Post-Approval Study ” has the meaning set forth in Section 5.2 .

 

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1.81        “ Pricing Approval ” means any and all pricing or reimbursement approvals of any Pricing Authority in any jurisdiction, in or outside of the Territory, that may be required for Commercialization of Product and Infusion set in such jurisdiction and/or for reimbursement of Product and Infusion set by national health insurance (or its local equivalent) or other governmental payors in such jurisdiction.

 

1.82        “ Pricing Authority ” means any supranational, national, regional, state or local Regulatory Authority in any jurisdiction, in or outside of the Territory, whose approval or authorization of pricing or reimbursement is required for Commercialization of Product and Infusion set in such jurisdiction and/or for reimbursement of Product and Infusion set by national health insurance (or its local equivalent) or other governmental payors in such jurisdiction.

 

1.83        “ Product ” means a product comprising Device pre-filled with Drug Product, including, without limitation, (a) the product known as Trevyent™ (PatchPump®-enabled treprostinil) as it exists, and is under development by, SteadyMed or its Affiliate in the Field in the U.S. as of the Effective Date, and (b) any improved or modified version of such product that is made by or on behalf of SteadyMed or any of its Affiliates during the Term for which SteadyMed or any of its Affiliates seeks or obtains Regulatory Approval in the Field in the U.S. from the FDA during the Term or which is actually Commercialized by SteadyMed or any of its Affiliates in the Field in the U.S. during the Term.

 

1.84        “ Product Labels and Inserts ” means (i) any display of written, printed or graphic matter upon the immediate container, outside container, wrapper or other packaging of a Supplied Item and (ii) any written, printed or graphic material on or within the package from which a Supplied Item is to be dispensed.

 

1.85        “ Product Marks ” means the Trevyent Mark and the PatchPump Mark.

 

1.86        “ Product-Specific Patents ” means Patents Controlled by SteadyMed or its Affiliates during the Term that: (a) specifically claim any formulation of treprostinil, any use or therapeutic application of any such formulation, or any method of making any such formulation; and (b) in the absence of a license thereunder, would be infringed (if issued or granted) by the manufacture, use, sale, offer for sale or import of the Drug Product; provided , however , that if any such Patent also claims (i) the formulation of any Other Drug, any use or therapeutic application of any formulation of any Other Product, or any method of making any formulation of any Other Product, and/or (ii) any aspect of the SteadyMed Platform, any of its components, or any combination of two or more of its components, including, without limitation, the design, use, function, assembly and manufacture of any of the foregoing, then, in each case, such Patent shall be deemed a Platform Patent and shall not be considered a Product-Specific Patent for purposes of this Agreement.

 

1.87        “ Product Warranty ” has the meaning provided in Section 12.3 .

 

1.88        “ Promotion ” means any activities undertaken by a pharmaceutical company aimed at encouraging the use of a particular pharmaceutical product. When used as a verb, “Promoting” means engaging in such activities and “Promote” and “Promoted” shall have corresponding meanings.

 

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1.89        “ Promotional Materials ” means all sales representative training materials and all written, printed, graphic, electronic, audio or video matter, including, without limitation, journal advertisements, sales visual aids, leave-behind items, formulary binders, reprints, direct mail, direct-to-consumer advertising, internet postings and sites and broadcast advertisements intended for use or used by or on behalf of Cardiome, any of its Affiliates or Sublicensees, and any of their respective Sales Forces, sales managers and other sales personnel in connection with Promotion of any Supplied Item.

 

1.90        “ Quality Agreement ” has the meaning provided in Section 4.3 .

 

1.91        “ Quarter ” means a calendar quarter.

 

1.92        “ QSR ” means the Quality System Regulation for medical devices, as described in 21 CFR Section 820, as amended from time to time.

 

1.93        “ Receiving Party ” has the meaning provided in Section 1.23 .

 

1.94        “ Region ” means any of (a) Europe, (b) the Middle East, or (c) Canada.

 

1.95        “ Regulatory Application ” has the meaning provided in Section 5.1(c) .

 

1.96        “ Regulatory Approval ” means any approval, authorization or clearance of any Regulatory Authority in any jurisdiction (in or outside of the Territory) that is necessary to market or sell Product and Infusion set in the Field in such jurisdiction, but excluding any Pricing Approval.

 

1.97        “ Regulatory Authority ” means any supranational, national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity whose review, approval or authorization is necessary for the manufacture, packaging, use, storage, import, export, distribution, promotion, marketing, offer for sale or sale of Product and Infusion set in any jurisdiction, in or outside of the Territory (including the FDA in the United States and the EMA in the European Union), but excluding any Pricing Authority.

 

1.98        “ Representatives ” means, with respect to a Party, such Party’s and its Affiliates’ respective officers, directors, employees, agents and representatives.

 

1.99        “ Royalty Base ” means, with respect to sales of a particular Product (i.e., SKU) in a particular country in a given Accounting Period, the difference between: (a) Net Sales of such Product in such country in such Accounting Period; and (b) the aggregate Transfer Price of such Product sold in such country in such Accounting Period, determined on a first-in, first-out (FIFO) basis (i.e., units of Products held in inventory for the longest time are assumed to be the first to be sold) in accordance with applicable Accounting Standards.

 

1.100      “ Sales Force ” means Cardiome’s and its Affiliates’ and Sublicensees’ respective Sales Representatives.

 

1.101      “ Sales Representative ” means a sales representative employed by Cardiome or any of its Affiliates or Sublicensees to Promote the Product in the Territory.

 

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1.102      “ SDEA ” has the meaning provided in Section 5.6 .

 

1.103      “ SDNs ” has the meaning provided in Section 2.7(b) .

 

1.104      “ Specifications ” means the specifications for a particular Supplied Item as set forth in the Quality Agreement, as the same may be amended from time to time in accordance with the Quality Agreement.

 

1.105      “ SteadyMed House Marks ” means (i) the SteadyMed trade name and logo, and (ii) any pending or future Trademark registrations, applications and unregistered Trademark rights, in each case, relating to the SteadyMed trade name and/or logo.

 

1.106      “ SteadyMed Know-How ” means Information Controlled by SteadyMed or its Affiliates during the Term that is necessary or useful for the use, sale, offer for sale, import or Commercialization of Product and Infusion set in the Field.

 

1.107      “ SteadyMed Patents ” means the Product-Specific Patents and the Platform Patents. Schedule 1.107 hereto lists the SteadyMed Patents existing as of the Effective Date.

 

1.108      “ SteadyMed Platform ” means SteadyMed’s proprietary PatchPump® drug administration technology for intravenous and subcutaneous delivery of liquid drugs, including, without limitation, the ECell expanding battery, hardware and software [...***...], various sensors [...***...], feedback LEDs to tell the patient the status of the product and an external status-check button.

 

1.109      “ SteadyMed Technology ” means the SteadyMed Patents and SteadyMed Know-How.

 

1.110      “ SteadyMed Trademarks ” means the Product Marks and the SteadyMed House Marks.

 

1.111      “ Subdistributor ” means a Third Party distributor of Supplied Items appointed or contracted by Cardiome or any of its Affiliates in a particular country of the Territory, where either:

 

(a)        such country is not a Major Market and such Third Party distributor has no royalty or other payment obligation to Cardiome or any of its Affiliates that is calculated based on amounts invoiced or received by such Third Party for in-market sales of Supplied Item in such country; or

 

(b)        such Third Party distributor (i) does not take title to Supplied Item, (ii) does not invoice Supplied Item sales to Third Party customers and (iii) is responsible only for inventory management and distribution on behalf of Cardiome or its Affiliate.

 

1.112      “ Sublicense ” means: (a) a sublicense under all or any portion of the license granted to Cardiome pursuant to Section 2.1 ; or (b) a right to promote, distribute and sell Supplied Item in any country of the Territory.

 

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1.113       “ Sublicensee ” means any Third Party to which Cardiome or any of its Affiliates grants a Sublicense, but excluding a Permitted Subdistributor.

 

1.114       “ Supplied Item ” means Finished Product, Bright Stock and/or Finished IS, as applicable.

 

1.115       “ Term ” has the meaning provided in Section 14.1 .

 

1.116       “ Territory ” means: (a) Europe; (b) the Middle East; and (c) Canada.

 

1.117       “ Third Party ” means any person or entity other than Cardiome, SteadyMed, and their respective Affiliates.

 

1.118       “ Trademark ” means any trademark, trade dress, brand mark, trade name, brand name, corporate name, logo, business symbol, Internet domain name or e-mail address, whether or not registered.

 

1.119       “ Transfer Price ” has the meaning provided in Section 4.6(a) .

 

1.120       “ Trevyent Mark ” means (i) the Trevyent™ mark and (ii) any pending or future Trademark registrations, applications and unregistered Trademark rights, in each case, relating to the Trevyent™ mark; but excluding, in each case, any SteadyMed House Mark.

 

1.121       “ Year ” means a calendar year.

 

Article 2

 

LICENSE

 

2.1           License Grant . Subject to the terms and conditions of this Agreement, SteadyMed hereby grants to Cardiome during the Term an exclusive (even as to SteadyMed except as expressly set forth below), royalty-bearing license, under the SteadyMed Technology, solely: (a) to use, sell, have sold, offer for sale, import and Commercialize Finished Products and/or Bright Stock in the Field in the Territory; and (b) to use, sell, have sold, offer for sale, import and Commercialize Finished IS in the Field in the Territory, solely and exclusively for use with Finished Products.

 

2.2           License Exclusions . The license granted to Cardiome pursuant to Section 2.1 specifically excludes:

 

(a)        any right under the SteadyMed Technology to Manufacture, or have Manufactured, Finished Product, API, Drug Product, Device, any Device component, Finished IS or any Finished IS component; and

 

(b)        any right under the SteadyMed Technology to use, sell, have sold, offer for sale, import or Commercialize:

 

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(i)        any Product other than Finished Product, Bright Stock or Finished IS supplied by SteadyMed hereunder;

 

(ii)        API, Drug Product, Device or any Device component except, in each case, as incorporated in Finished Product, Bright Stock or Finished IS supplied by SteadyMed hereunder;

 

(iii)        any subcutaneous, intravenous or other infusion device to connect Finished Product (or the Device incorporated therein) or Bright Stock to the patient’s body, other than Finished IS;

 

(iv)        Finished IS independently of Finished Product or Bright Stock or for any use other than use with Finished Product or Bright Stock; and

 

(v)        Infusion Sets, other than Finished IS supplied by SteadyMed hereunder.

 

In addition, and for the avoidance of doubt, the license granted to Cardiome pursuant to Section 2.1 excludes any license or other right with respect to any Other Drug, including, without limitation, any Device or other product using SteadyMed Technology that is pre-filled with any Other Drug or that an end user may pre-fill with any Other Product, or any Infusion set for use with any Other Drug.

 

2.3           Sublicensing; Appointment of Subdistributors .

 

(a)        The license granted to Cardiome pursuant to Section 2.11 includes the right to grant Sublicenses: (i) in the Territory or any portion thereof, to Cardiome’s Affiliates Correvio International Sárl, Correvio GmbH (Germany), Cardiome UK and Correvio UK without SteadyMed’s consent; and (ii) in the Territory or any portion thereof, to any other Affiliate of Cardiome upon [...***...] prior written notice to SteadyMed, provided that if SteadyMed in good faith objects to the grant of a Sublicense to any such Affiliate and so notifies Cardiome thereof within such [...***...] period, then Cardiome shall not have the right to grant a Sublicense to such Affiliate. Cardiome shall not have the right to grant Sublicenses to any Third Party without SteadyMed’s prior written consent, which may not be unreasonably withheld. Any and all Sublicenses granted by Cardiome shall be in writing and shall be subject to, and consistent with, the terms and conditions of this Agreement. Cardiome shall be fully responsible for the compliance of its Affiliates and Sublicensees with the terms and conditions of this Agreement. Within [...***...] after execution of any Sublicense agreement with a Third Party, Cardiome shall provide SteadyMed with a full and complete copy of such Sublicense agreement (provided that Cardiome may redact any confidential information contained therein that is not necessary to ascertain compliance with this Agreement).

 

(b)        Cardiome and its Affiliates shall have the right, without SteadyMed’s consent, to appoint any Subdistributor that Cardiome or any of its Affiliates has appointed, and actually uses, as a subdistributor (as defined in Section 1.111 , mutatis mutandis ) of pharmaceutical products of Cardiome and its Affiliates in a country of the Territory as of the Effective Date, solely to distribute Finished Product, and Finished IS with Finished Product, in such country (each, a “ Permitted Subdistributor ”). Neither Cardiome nor any of its Affiliates shall have the right to appoint any Subdistributor other than a Permitted Subdistributor without the prior written consent of SteadyMed, which consent may not be unreasonably withheld. Any appointment of a Permitted Subdistributor shall be in writing and shall be subject to, and consistent with, the terms and conditions of this Agreement. Cardiome shall be fully responsible for the compliance of its and its Affiliates’ Permitted Subdistributors with the terms and conditions of this Agreement.

 

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2.4           Reservation of Rights . Notwithstanding the exclusivity of the license granted to Cardiome pursuant to Section 2.1 , SteadyMed hereby reserves such non-exclusive rights under the SteadyMed Technology as are necessary or useful for the performance of SteadyMed’s obligations under Article 4 . SteadyMed hereby reserves the exclusive (even as to Cardiome) right to practice and grant licenses under the SteadyMed Technology for all purposes other than the use, sale, offer for sale, import and Commercialization of Products and Infusion Sets (including, without limitation, Finished Product, Bright Stock and Finished IS), in each case, in the Field in the Territory. Without limiting the generality of the foregoing, SteadyMed specifically reserves the exclusive right to practice and grant licenses under the SteadyMed Technology:

 

(a)        to research, develop, use, sell, have sold, offer for sale, import and Commercialize Products (including, without limitation, Finished Products and Bright Stock), API, Drug Product, Devices and Infusion Sets (including, without limitation, Finished IS) outside the Territory for any and all purposes;

 

(b)        to research, develop, use, sell, have sold, offer for sale, import and Commercialize the SteadyMed Platform and products based on or using the SteadyMed Platform (except, in each case and solely in the Territory, as incorporated in Product) throughout the world, whether with or without any Other Drug; and

 

(c)        to research, develop, use, sell, have sold, offer for sale, import and Commercialize Devices (except, in each case and solely in the Territory, as incorporated in Product) and Infusion Sets (except, in each case and solely in the Territory, for use with Product) throughout the world, whether with or without any Other Drug.

 

2.5           Negative Covenant . Cardiome hereby covenants not to practice, and not to permit or cause any Affiliate, Sublicensee or other Third Party to practice, any SteadyMed Technology for any purpose other than as expressly authorized in this Agreement.

 

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2.6           Territory .

 

(a)        Cardiome hereby covenants and agrees that neither Cardiome nor any of its Affiliates shall, and each of them shall require their respective Sublicensees and Permitted Subdistributors not to, directly or indirectly, sell, have sold, offer for sale, import, export, deliver or Commercialize Product outside of the Territory. Without limiting the generality of the foregoing, neither Cardiome nor any of its Affiliates shall, and each of them shall require their respective Sublicensees and Permitted Subdistributors not to: (i) engage in any advertising or promotional activities relating to Product directed to customers or other buyers or users of Product outside the Territory; or (ii) solicit orders from any prospective purchaser located outside the Territory. Cardiome further covenants and agrees that neither Cardiome nor any of its Affiliates shall knowingly sell Product to any person inside the Territory that Cardiome or its Affiliate knows intends to use or sell such Product outside the Territory. If Cardiome or its Affiliate, Sublicensee or Permitted Subdistributor receives any order for Product from a prospective purchaser located outside the Territory, Cardiome shall promptly notify SteadyMed in writing. Neither Cardiome nor any of its Affiliates, Sublicensees or Permitted Subdistributors shall accept any such orders. Notwithstanding anything in this Agreement to the contrary, SteadyMed acknowledges and agrees that certain advertising, promotion or marketing of the Product in the Territory, including the advertising, promotion and marketing of the Product through the use of the internet and pan-regional print advertisements and at conferences and seminars held in the Territory, may reach Persons outside the Territory, and Cardiome shall not be in breach of this Agreement by reason thereof so long as (1) the objective of such advertising, promotion or marketing is to reach Persons within the Territory or otherwise to promote sales of the Product within the Territory, or (2) the receipt by Persons located outside the Territory of such advertising, promotion or marketing of the Product is merely incidental to the objectives of such advertising, promotion or marketing in the Territory. Notwithstanding the above, the Parties through the JSC may elect to jointly participate in worldwide or global conferences.

 

2.7           Export Control .

 

(a)         Export Control Laws . In exercising its rights under this Agreement, each Party agrees to comply strictly and fully with U.S. export control laws, including the Arms Export Controls Act (22 U.S.C. Ch. 39), the International Emergency Economic Powers Act (50 U.S.C. §§ 1701 et seq.), the Trading With the Enemy Act (50 U.S.C. app. § § 1 et seq.), the Export Administration Act of 1979 (50 U.S.C. app. §§ 2401 et seq.), International Boycott Provisions of Section 999 of the U.S. Internal Revenue Code of 1986, and all rules, regulations and executive orders relating to any of the foregoing, including but not limited to the International Traffic in Arms Regulations (22 C.F.R. §§ 120 et seq.), the Export Administration Regulations (15 C.F.R. §§ 730 et. seq.), and the regulations administered by the Office of Foreign Assets Controls of the United States Department of the Treasury, and all export controls imposed on the Supplied Items by any country or organization or nations within whose jurisdiction Cardiome operates or does business (collectively, “ Export Control Laws ”). Cardiome will not export or permit exportation of any part of the Supplied Items or any related technical data or any direct product of any related technical data, outside of the United States without obtaining SteadyMed’s prior written consent and any required written permission, license, or approval to do so from the Bureau of Industry and Security of the U.S. Department of Commerce and/or other appropriate governmental agencies of the United States.

 

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(b)           Restricted Destinations and End-Users . Cardiome shall not (i) export, reexport, or transfer any Supplied Items to any country that is at the time of export, reexport or transfer subject to an embargo by the U.S. government; (ii) export, reexport, or transfer any Supplied Items to any instrumentality, agent, entity, or individual that is acting on behalf of, or directly or indirectly owned or controlled by, any governmental entity that is subject to an embargo by the U.S. government; (iii) export, reexport or transfer any Supplied Items to a national of a country that is subject to an embargo of the U.S. government; and (iv) engage in any transactions or dealings with any organization, entity, or individual identified on the List of Specially Designated Nationals and Blocked Persons (“ SDNs ”) or the Foreign Sanctions Evaders List, which are both maintained by the Office of Foreign Assets Control of the U.S. Treasury Department, or the Entity List, Denied Persons List, or Unverified List, which are maintained by the Bureau of Industry and Security of the U.S. Commerce Department. Notwithstanding the above, Cardiome may export, reexport, or transfer any Supplied Items as permitted by Applicable Law or based upon specific or general licenses allowed by Applicable Law at the export, reexport or transfer of the Supplied Item. The Parties acknowledge that the above prohibitions do change from time to time, and any changes in the above can be discussed by the Joint Steering Committee.

 

(c)           Obligation to Report . Either Party will immediately report to the to the Party (i) any concerns, suspicions, or actual knowledge of violations of the Export Control Laws or any other similar applicable export control law, or (ii) if either Party becomes the subject of any formal or informal investigation, prosecution, or government or judicial determination related to a violation of Export Control Laws or any other similar applicable export control law.

 

(d)           Obligation to Cooperate : Each Party will fully cooperate and cause its Representative Persons to cooperate with the other Party in the other Party’s review or investigation in relation to an actual or potential violation of any applicable export law or regulation.

 

(e)           Termination for Non-Compliance . Each Party understands and acknowledges that, notwithstanding any provision contained herein,

 

(i)        a knowing intentional violation of this Section 2.7 by any either Party shall be deemed a material breach of this Agreement and will entitle the other Party to (i) terminate this Agreement immediately for cause, and (ii) be indemnified for and held harmless against any and all damages, fines, penalties, disgorgements, settlements, determinations, or claims faced by or imposed on the non-breaching Party or any of its representatives to the extent attributable to the material breach of this Section by the breaching Party or any of its respective directors, officers, employees, consultants, agents, Sublicensees, subcontractors, distributors, Subdistributors or other representatives’ and

 

(ii)        a non-intentional violation of this Section 2.7 by either Party shall be deemed a non-material breach of this Agreement. Such a breach may be cured by reporting as soon as practicable the basis of the breach to the regulatory agency responsible for the applicable export control laws. In addition each Party must thereafter cooperate with said agency during any investigation and with any subsequent fines or remediation imposed by said agency.

 

2.8         No Implied License . No right or license under any Patents or Information of either Party is granted or shall be granted by implication. All such rights or licenses are or shall be granted only as expressly provided in this Agreement.

 

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Article 3

 

JOINT STEERING COMMITTEE

 

3.1         Joint Steering Committee Formation; Composition . Within 10 days after the Effective Date, the Parties shall establish a joint steering committee (the “ JSC ”) composed of no more three (3) representatives of each of SteadyMed and Cardiome. Each Party may change its representatives to the JSC, or delegate another representative to attend any meeting thereof, from time to time in its sole discretion, effective upon notice to the other Party of such change or delegation. These representatives shall have appropriate technical credentials, experience and knowledge. The JSC will be jointly chaired by the Parties, with each Party designating one of its JSC representatives as its co-chairperson. The chairpersons shall set agendas for JSC meetings in advance, provided that the agendas will include any matter requested by either Party and within the scope of the JSC’s authority. A reasonable number of additional representatives of a Party may attend meetings of the JSC in a non-voting capacity.

 

3.2         Responsibilities and Authority . The JSC’s overall responsibility shall be to encourage and facilitate ongoing cooperation and communication between the Parties and to perform the other obligations specifically delegated to it by this Agreement, subject to the limitations set forth in this Article 3 . In particular, the JSC shall:

 

(a)        review, coordinate, and discuss the overall strategy for obtaining Regulatory Approvals, Pricing Approvals and reimbursement status for the Product in the Field in the Territory;

 

(b)        review and discuss the protocols for any Post-Approval and/or Reimbursement Study to be conducted by or on behalf of Cardiome or any of its Affiliates, subject to Section 5.2 hereof;

 

(c)        review and discuss ongoing and planned Commercialization activities and spending in the Territory, including, without limitation, countries in which Product will be launched and priority thereof, pre-launch activities, retention of reimbursement consultant(s), efforts to obtain Pricing Approvals and reimbursement status, sales and marketing commitment and strategy, use and distribution of Promotional Materials and Non-Commercial Product, reimbursement and third-party payor status, and product distribution logistics;

 

(d)        determine the number of Non-Commercial Product samples to be supplied by SteadyMed, whether for the Launch Period or otherwise;

 

(e)        review progress of Commercialization activities and metrics with respect to Product in the Field in the Territory against Commercialization Plans;

 

(f)        ensure consistency of Commercialization activities in the Territory with SteadyMed’s global marketing strategy and efforts for the Product;

 

(g)        monitor Cardiome inventory levels of Supplied Items;

 

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(h)        provide a forum for discussion of Product Manufacturing and supply matters, subject to Article 4 hereof; and

 

(i)        perform such other duties as are specifically assigned by the Parties to the Joint Steering Committee pursuant to this Agreement.

 

Each Party shall be responsible for ensuring that, at all times, its representatives on the JSC act reasonably and in good faith in carrying out their respective responsibilities hereunder.

 

3.3         JSC Meetings . The JSC shall meet as deemed necessary by the JSC members, but, no less often than quarterly, commencing January 2016. The location for such meetings shall mutually agreed by the Parties. Alternatively, the JSC may meet by means of teleconference, videoconference or other similar communications equipment. Each Party shall be responsible for all of its own expenses of participating in JSC meetings.

 

3.4         Quarterly Review/Monthly Supply Chain Meeting . In addition to the JSC Meetings (or, as part of the JSC Meetings) the Parties agree to meet at least once per calendar quarter to review current Forecasts and to discuss Cardiome’s future projected requirements for supply of the Product as well as Regulatory or other related matters, beginning October 2016.

 

3.5         Minutes . Responsibility for preparing definitive minutes of each JSC meeting shall alternate between the Parties. The responsible Party shall circulate a draft of the minutes of each meeting to all members of the JSC for comments within 10 days after such meeting. Such minutes shall provide a description, in reasonable detail, of the discussions at the meeting and shall document all actions and determinations approved by the JSC at such meeting. The Parties shall promptly discuss any comments on such minutes and finalize the minutes no later than the date of the next JSC meeting.

 

3.6         Decision-Making . Decisions of the JSC shall be made by unanimous vote, with each Party’s representatives on the JSC collectively having one vote. No vote of the JSC may be taken unless at least one of each Party’s representatives is present and participating in such vote. The JSC’s decision-making authority shall be limited to those matters expressly delegated to it in this Agreement. The JSC shall use reasonable efforts to resolve any disputes or disagreements concerning the matters within the scope of its authority.

 

3.7         Disputes . If the JSC cannot reach consensus regarding any matter within the scope of its authority within [...***...] after it has met and attempted to reach such consensus, then either Party may, by written notice to the other Party (an “ Escalation Notice ”), refer such matter to the Chief Executive Officer of SteadyMed and the Chief Executive Officer of Cardiome (collectively, the “ Senior Executives ”) for attempted resolution. The Senior Executives shall use good faith efforts to resolve any matter referred to them as soon as practicable. If the Senior Executives are unable to resolve any matter set forth in an Escalation Notice within [...***...].

 

3.8         Scope of Governance . Notwithstanding the creation of the JSC, each Party shall retain the rights, powers and discretion granted to it under this Agreement, and the JSC shall not be delegated or vested with any rights, powers or discretion unless such delegation or vesting is expressly provided in this Agreement. The JSC shall not have any power to amend or modify this Agreement, and no decision of the JSC shall be enforceable to the extent it is in contravention of any terms and conditions of this Agreement.

 

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3.9         Alliance Managers . Within 30 days after the Effective Date, each Party shall appoint a representative (“ Alliance Manager ”) to facilitate ongoing communications and exchange of information between the Parties and to act as a liaison between the Parties. Each Party may replace its Alliance Manager at any time upon notice to the other Party.

 

Article 4

 

MANUFACTURING AND SUPPLY

 

4.1         Manufacture and Supply . Subject to the terms and conditions of this Agreement, SteadyMed, itself or through its Affiliates or Third Party contract manufacturers, shall be responsible for Manufacturing, or having Manufactured, Supplied Items for Commercialization in the Territory, and shall supply (or have supplied) to Cardiome, and Cardiome shall purchase exclusively from SteadyMed, its requirements of Supplied Items for Commercialization by Cardiome and its Affiliates, Sublicensees and Permitted Subdistributors in the Territory. Cardiome acknowledges and agrees that SteadyMed may perform any of its Manufacturing and supply obligations under this Article 4 through one or more Third Party contract manufacturers, provided that SteadyMed shall be fully responsible for the compliance of its Third Party contract manufacturers with the terms and conditions of this Agreement.

 

4.2         Packaging and Labeling . Finished Product will be fully labeled and packaged as required by each market when supplied to Cardiome including product serialization according to the destination market requirements and supported with the required electronic data files as specified by the markets. Bright Stock will be supplied by SteadyMed to Cardiome for sale in the Middle East. As utilized herein, “ Bright Stock ” refers to unlabeled Product having a Device pre-filled with a specified quantity of Drug, and an Infusion Set. The cost complied with complying with this paragraph will be included in COGS.

 

4.3         Quality Agreement . No later than three (3) months after the Effective Date, the Parties shall enter into a written quality assurance agreement setting forth the specific responsibilities, procedures and guidelines for batch release, quality control testing, quality assurance review, acceptance testing and other quality-related aspects of the manufacture and release of Supplied Items hereunder (as such agreement may be amended from time to time by mutual written agreement of the Parties, the “ Quality Agreement ”). Each Party agrees to perform the responsibilities assigned to such Party under the Quality Agreement in accordance with the terms and conditions of the Quality Agreement. In case of any conflict between the provisions of this Agreement and those of the Quality Agreement, the Quality Agreement shall prevail as to any quality-related matter, and this Agreement shall prevail as to all other matters.

 

4.4         Manufacturing Standards . SteadyMed shall be responsible for ensuring that Supplied Items supplied to Cardiome hereunder conform to the applicable Specifications in effect as of the applicable Delivery Date and are Manufactured in accordance with applicable Manufacturing Standards and SteadyMed’s obligations under the Quality Agreement. SteadyMed shall also be responsible for ensuring that, as of the Delivery Date of any Supplied Item, such Supplied Item shall have a remaining shelf-life of at least [...***...] as of the Launch Date, and at least [...***...] after the Launch Date. In addition, SteadyMed will endeavor to [...***...].

 

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4.5           Forecasts and Purchase Orders .

 

(a)         Initial Forecast . No later than [...***...] prior to the expected Launch Date, Cardiome shall provide SteadyMed Cardiome’s good faith estimate of anticipated orders of each Supplied Item for the Territory for delivery during [...***...] of the Initial Forecast Period (the “ Initial Forecast ”). In addition, the Initial Forecast shall separately specify: (i) Cardiome’s good faith estimate of the Launch Quantity; and (ii) Cardiome’s good faith estimate of the number of Non-Commercial Units of each Supplied Item required for delivery during the Launch Period, provided that the aggregate number of Non-Commercial Units of a Supplied Item for the Launch Period shall not exceed the JSC-approved quantity of such Supplied Item. Cardiome shall have the right, but not the obligation, to provide SteadyMed one or more updated Initial Forecasts no later than the date that is [...***...] prior to the expected Launch Date. The forecasted Launch Quantity and forecasted Non-Commercial Quantity set forth in the last Initial Forecast (or update thereto) provided by Cardiome prior to the date specified in the preceding sentence shall be a binding commitment by Cardiome to place purchase orders for such forecasted quantities.

 

(b)         Rolling Forecasts . On the first day of each Quarter after the last date on which an updated Initial Forecast may be delivered under Section 4.5(b) , Cardiome shall provide SteadyMed a rolling [...***...] Quarter forecast of Cardiome’s good faith estimate of anticipated orders of each Supplied Item for each country of the Territory for delivery during each Quarter of such [...***...] period (each, a “ Forecast ”). For clarity, the [...***...] covered by each Forecast shall be [...***...] beginning no earlier than [...***...] after the date such Forecast is submitted to SteadyMed. The [...***...] of each such Forecast shall be a binding commitment by Cardiome to place purchase orders for the forecasted quantities of Supplied Items. The [...***...] of each such forecast may be increased or decreased by no more than [...***...] without the written consent of SteadyMed. The [...***...] of each such forecast may be increased or decreased by no more than [...***...] without the written consent of SteadyMed. Each such Forecast shall otherwise be non-binding, except as provided below, but shall reflect Cardiome’s good faith expectation (at the time of submitting the Forecast) of the orders of Supplied Item to be delivered during the Forecast period.

 

(c)         Orders . Subject to Sections 4.5(a) and 4.5(b) , Cardiome shall order Supplied Items by submitting written purchase orders, in such form as the Parties shall agree from time to time, to SteadyMed specifying (i) the quantity of each Supplied Item ordered for each country of the Territory, separately set forth on a country-by-country basis, and (ii) the desired Delivery Date for such Supplied Item, which Delivery Date shall be no earlier than [...***...] from submission of purchase order. Cardiome shall submit its purchase order for the binding portion of each Forecast to SteadyMed at least [...***...] in advance of the desired Delivery Date. In addition, Cardiome shall submit its purchase order for the Launch Quantities and the number of Non-Commercial Units of each Supplied Item required for the Launch Period (the “ Non-Commercial Quantity ”), not to exceed the applicable JSC-approved number of Non-Commercial Units of such Supplied Product for the Launch Period, no later than [...***...] prior to the anticipated Launch Date. All purchase orders shall be subject to acceptance by SteadyMed. Each purchase order submitted by Cardiome to SteadyMed shall reference this Agreement and shall be governed exclusively by the terms contained herein. The Parties hereby agree that the terms and conditions of this Agreement shall supersede any term or condition in any purchase order, confirmation or other document furnished by Cardiome or SteadyMed that is in any way inconsistent with these terms and conditions. Not later than [...***...] after receipt of a purchase order, SteadyMed shall confirm its receipt of the purchase order and the expected Delivery Date(s) of the ordered quantities to Cardiome in writing. For any purchase order that exceeds the forecasted quantity specified in the binding portion of a Forecast, SteadyMed shall notify Cardiome whether or not SteadyMed will be able to fulfill the excess portion of such purchase order (or part thereof) and the expected Delivery Date(s) for such excess quantities. SteadyMed shall use Commercially Reasonable Efforts to supply to Cardiome any such excess quantities as soon as reasonably practicable. Each purchase order shall be for a minimum of [...***...], subject to renegotiation [...***...].

 

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4.6          Transfer Prices and Payment for Supplied Items .

 

(a)         Transfer Price . The transfer price payable by Cardiome for each unit of a particular Supplied Item ( i.e. , having a particular SKU) supplied hereunder (including, without limitation, each Non-Commercial Unit of such Supplied Item) shall equal [...***...] of such Supplied Item (the “ Transfer Price ”), except that:

 

(i)         solely for Non-Commercial Quantity of a Supplied Item, the “ Transfer Price ” payable by Cardiome for Non-Commercial Units of such Supplied Item shall equal [...***...] of the applicable Transfer Price determined in accordance with the first paragraph of this Section 4.6(a) (the “ Non-Commercial Transfer Price ”); and

 

(ii)        if, after a particular Supplied Item has been commercially sold by Cardiome or its Affiliate or Sublicensee in a particular country of the Territory [...***...], the Cardiome Margin for such Supplied Item in such country [...***...], then for subsequent [...***...], the Transfer Price of units of such Supplied Item supplied hereunder for such country only (as set forth in purchase orders submitted by Cardiome) shall be [...***...]; provided , however , that if, after the [...***...], then, for subsequent [...***...] shall cease to apply.

 

(iii)        The COGS of the Supplied Item [...***...] will not [...***...].

 

(b)           Deposit . [...***...] shall pay the applicable invoiced amount within [...***...] after receipt of invoice in accordance with Section 8.2 .

 

(c)           Invoicing and Payment of Transfer Price . For each delivery of a Supplied Item, SteadyMed shall issue an invoice to Cardiome, no earlier than the Delivery Date, for, as applicable:

 

(i)        the Transfer Price for the number of units of such Supplied Item (other than the Non-Commercial Product Quantities) in such delivery, which invoice shall specify [...***...]; or

 

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(ii)        solely in the case of the Non-Commercial Product Quantities, the Non-Commercial Transfer Price for the number of Non-Commercial Units of such Supplied Item in such delivery, which invoice shall specify [...***...].

 

In each case, Cardiome shall pay the applicable invoiced amount, net of the applicable deposit paid by Cardiome pursuant to Section 4.6(b) , within [...***...] after receipt of invoice in accordance with Section 8.2 .

 

4.7         Specifications; Change Management . Any change to the Specifications for a Supplied Item will require the mutual written agreement of the Parties. The formal procedures for the approval and documentation of all changes to the Specifications for a Supplied Item or to the materials, equipment, process or procedures used to Manufacture a Supplied Item to be supplied to Cardiome hereunder shall be as set forth in the Quality Agreement.

 

4.8         Delivery; Packaging . SteadyMed shall use Commercially Reasonable Efforts to deliver all Supplied Items ordered by Cardiome by the desired Delivery Date set forth on the applicable purchase order, provided that such desired Delivery Date is at least [...***...] after the date of the applicable purchase order and such order is consistent with Cardiome’s binding forecast quantities. Delivery of Supplied Items ordered by Cardiome hereunder shall be made [...***...]. […***…] shall be responsible for obtaining all licenses or other authorizations for the exportation of Supplied Items out of the country where the applicable Manufacturing Facility is located and importation of Supplied Items into the Territory, and for all customs duties and tariffs in connection therewith, as well as for complying with all import reporting requirements for customs and duty classification and reporting. [...***...] agrees to cooperate with and provide any necessary documentation required for exportation, and aggress to cause its vendors to provide such cooperations. [...***...] shall be responsible for contracting, at its own expense, for shipment of Supplied Items from the [...***...]. Title and risk of loss shall pass to Cardiome upon delivery of the Supplied Item to [...***...]. Supplied Items shall be packaged for shipment in accordance with the applicable Specifications and SteadyMed’s or its Contract Manufacturer’s standard operating procedures.

 

4.9          Acceptance and Rejection .

 

(a)        Cardiome shall inspect all shipments of Supplied Items promptly upon receipt and may reject any shipment of Supplied Items or portion thereof that fails to conform to the Product Warranty (“ Defective Product ”). In order to reject any shipment of Supplied Items or portion thereof, Cardiome must give written notice of rejection to SteadyMed within [...***...] after receipt of such Supplied Item at Cardiome’s or its designee’s address for delivery specified in the applicable purchase order (or, in the case of any Latent Defect, within [...***...] after discovery by Cardiome of the Latent Defect, but [...***...]). Should Cardiome fail to give written notice of rejection to SteadyMed within [...***...] after such receipt or [...***...] after discovery of a Latent Defect, as applicable, then the Supplied Item will be deemed to have been accepted by Cardiome on the [...***...] after such receipt or the [...***...] after discovery of the Latent Defect, as applicable.

 

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(b)        Promptly after timely delivery to SteadyMed of any notice of rejection, Cardiome shall cooperate with SteadyMed in determining whether such rejection is necessary or justified. SteadyMed will evaluate process issues and other reasons for any non-conformity. SteadyMed shall notify Cardiome as promptly as reasonably possible whether it accepts Cardiome’s basis for any rejection. Whether or not SteadyMed accepts Cardiome’s assertion that certain Supplied Item is Defective Product, SteadyMed shall use Commercially Reasonable Efforts to replace such allegedly Defective Product with Supplied Item that conforms to the Product Warranty as promptly as practicable. If SteadyMed disagrees with Cardiome’s assertion that certain Supplied Item is Defective Product, a sample of the rejected Supplied Item shall be submitted to a mutually acceptable independent Third Party laboratory, which shall determine whether such Supplied Item is Defective Product. The Parties agree that such laboratory’s determination shall be final and binding upon the Parties. The Party against whom the Third Party laboratory rules shall bear the reasonable costs of such testing. If the Third Party laboratory rules that the Supplied Item is not Defective Product, Cardiome shall purchase such Supplied Item at the agreed-upon price, irrespective of whether SteadyMed has already replaced it.

 

4.10         Remedy for Defective Products . In the event of Cardiome’s rejection of Defective Products in accordance with Section 4.9 , SteadyMed shall promptly, at Cardiome’s election, either: (i) refund the aggregate amount paid for the Defective Products, if Cardiome previously paid for such Defective Products; (ii) offset the amount paid for the Defective Products, if Cardiome previously paid for such Defective Products, against other amounts due to SteadyMed hereunder; or (iii) at no cost to Cardiome beyond the amount invoiced for the Defective Products, replace the Defective Products with Supplied Items conforming to the Product Warranty as promptly as practicable. This Section 4.10 and Section 4.9 above collectively set forth Cardiome’s exclusive remedy, and SteadyMed’s sole liability, for delivery of Defective Product.

 

4.11         Disposition of Rejected Product . Cardiome shall dispose of rejected Supplied Items as instructed by SteadyMed in writing. If SteadyMed fails to instruct Cardiome as to the disposition of rejected Supplied Items within [...***...] after SteadyMed notifies Cardiome that SteadyMed accepts Cardiome’s basis for rejection of such Supplied Item or the issuance of the Third Party laboratory’s determination regarding the conformity or non-conformity of the rejected Supplied Items to the Product Warranty (as applicable), Cardiome may either return such rejected Supplied Item to SteadyMed or destroy such rejected Supplied Item in compliance with Applicable Laws, and SteadyMed shall promptly reimburse Cardiome for all direct, documented out-of-pocket costs incurred by Cardiome in respect of such return or destruction.

 

4.12         Cardiome Review of Quality Control Documentation . SteadyMed, or SteadyMed’s vendors shall maintain all quality control documentation and Product acceptance test results for Supplied Item supplied hereunder for a period and in a manner consistent the Quality Agreement and applicable Manufacturing Standards. Cardiome may periodically review as often as necessary such documentation and results, and, as set forth in the Quality Agreement, verify the adherence of SteadyMed to the quality control procedures and standards set forth in the Quality Agreement or prescribed by applicable Manufacturing Standards. Such review shall be on reasonable prior notice and conducted during business hours and in a manner that does not unreasonably disrupt SteadyMed’s business or operations.

 

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4.13         Facility Inspection by Cardiome . SteadyMed agrees, and shall use Commercially Reasonable Efforts to obtain each Contract Manufacturer’s agreement, that a reasonable number of Cardiome representatives (but no more than a total of three persons per inspection) shall have the right, pursuant to a reasonable confidentiality agreement with SteadyMed and the applicable Contract Manufacturer, no more than once per Year (unless any such inspection reveals a material compliance issue, in which event Cardiome and its respective agents shall have the right to conduct such additional inspections during such Year as necessary to verify that such issue has been remedied), upon reasonable prior notice to SteadyMed and the applicable Manufacturer and during business hours, and in a manner that does not disrupt SteadyMed’s or the applicable Manufacturer’s operations, to inspect the portion of the applicable Manufacturing Facility where the applicable Supplied Item is Manufactured as well as to observe the Manufacturing of the Supplied Item. If the request for inspection is made at Cardiome’s request, Cardiome will pay for the costs of said inspection if so required by the applicable Contract Manufacturer (unless such inspection reveals a material compliance issue). Following such inspection, Cardiome shall discuss its observations and conclusions with SteadyMed. If the Parties mutually agree that any corrective actions by SteadyMed or a Manufacturer are necessary, SteadyMed shall use Commercially Reasonable Efforts to implement, or cause the Manufacturer to implement, such agreed corrective actions as soon as practicable.

 

4.14         Regulatory Inspections .

 

(a)         Inspection by Regulatory Authorities in the Territory . Upon the request of any Regulatory Authority in a country of the Territory in which Cardiome or its Affiliate has filed a Regulatory Application or obtained Regulatory Approval for Finished Product or finished Bright Stock in the Field, SteadyMed shall provide, and use its Commercially Reasonable Efforts to contractually require and cause each Contract Manufacturer listed in the registration dossier to provide, such Regulatory Authority reasonable access to observe and inspect the applicable Manufacturing Facility and the procedures used for the Manufacture of the applicable Supplied Item and to audit such facility for compliance with applicable Manufacturing Standards. Without limiting the generality of the foregoing, SteadyMed agrees to cooperate, and to use Commercially Reasonable Efforts to cause each Contract Manufacturer to cooperate, with any inspection by any such Regulatory Authority, and to provide Cardiome a copy of any inspection or audit report resulting from any such inspection.

 

(b)         Notification of Inspections . SteadyMed agrees to notify or to cause the applicable Contract Manufacturer to notify Cardiome within [...***...] of any written or oral inquiries, notifications or inspection activity by the FDA or the applicable Regulatory Authority in a Major Market specifically in regard to a Supplied Item and immediately by telephone after learning of any such unannounced visit or inspection. SteadyMed shall furnish to Cardiome (i) within [...***...] after receipt, any report or correspondence issued by the FDA or any such Regulatory Authority in a Major Market in connection with such inquiry, notification or inspection, including any FDA Form 483 (List of Inspectional Observations) or applicable portions of any FDA Warning Letters that pertain to a Supplied Item, and (ii) not later than [...***...] after submission to FDA or any such other Regulatory Authority, copies of responses or explanations relating to items set forth above, in each case redacted of trade secrets or other confidential information of SteadyMed or the applicable Contract Manufacturer that are unrelated to SteadyMed’s obligations under this Article 4 and the Manufacture of Supplied Items hereunder. After the filing of such response with the FDA or such other Regulatory Authority, SteadyMed shall promptly notify Cardiome of any further contacts with the FDA or such Regulatory Authority relating to the subject matter of the response.

 

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(c)         Remedial Actions . SteadyMed shall notify, or shall cause the applicable Contract Manufacturer to notify, Cardiome immediately in writing in the event any action is taken or threatened by FDA or any Regulatory Authority in a Major Market relating to the Manufacture of a Supplied Item or to the applicable Manufacturing Facility that, in each case, would reasonably be expected to impair the ability of SteadyMed to Manufacture, or have Manufactured, and supply such Supplied Item in accordance with this Agreement. SteadyMed shall use Commercially Reasonable Efforts to address and resolve as soon as possible any issues, concerns or warnings from any such Regulatory Authority that would reasonably be expected to affect SteadyMed’s ability to Manufacture, or have Manufactured, and supply Supplied Items in accordance with this Agreement. To the extent SteadyMed or the applicable Contract Manufacturer is required by such Regulatory Authority to implement a plan of remediation or to make other modifications or changes to the applicable Manufacturing Facility or Manufacturing processes in order to address and resolve any such issues, concerns or warnings, SteadyMed shall prepare, or cause the Contract Manufacturer to prepare, such plan as soon as possible and provide a copy thereof to Cardiome, and shall use Commercially Reasonable Efforts to implement, or to cause the Contract Manufacturer to implement, such plan as soon as possible.

 

Article 5

 

REGULATORY MATTERS

 

5.1          Regulatory Responsibility .

 

(a)        Cardiome shall be solely responsible for regulatory matters for Supplied Items in the Field in the Territory, at Cardiome’s sole expense (except as expressly set forth below). Without limiting the generality of the foregoing, Cardiome shall be solely responsible, at its sole expense (except as expressly set forth below), for: (i) filing and maintaining applications for Regulatory Approval and obtaining and maintaining Regulatory Approvals for Supplied Items in the Field in the Territory; (ii) complying with all post-approval regulatory and medical reporting obligations for Supplied Items in the Territory; and (iii) verifying and assuring the compliance of Product Labels and Inserts and Promotional Materials with Applicable Laws in the Territory. SteadyMed shall cover [...***...] of the filing fees payable to Regulatory Authorities in the Major Markets with respect to applications for Regulatory Approval for Supplied Items in the Field in the Major Markets up to a maximum of [...***...] in the aggregate. Cardiome shall be the sponsor and sole owner of all applications for Regulatory Approval and all Regulatory Approvals for Supplied Items in the Field in the Territory.

 

(b)         For the avoidance of doubt, and notwithstanding Section 5.1(a) or any other provision of this Agreement to the contrary : (i) SteadyMed shall be solely responsible for, and shall have the sole right to control, all worldwide regulatory matters for the Device and the SteadyMed Platform, and SteadyMed shall be the sole owner of all regulatory filings and regulatory approvals with respect to the Device (other than as incorporated in Finished Product or Bright Stock for Commercialization in the Field in the Territory) and the SteadyMed Platform, provided that SteadyMed shall grant Cardiome the right to access and reference, and authorize Regulatory Authorities in the Territory to access and reference, such regulatory filings and regulatory approvals of SteadyMed to the extent necessary for Cardiome to apply for, obtain and maintain Regulatory Approvals for Supplied Items in the Field in the Territory in accordance with this Agreement; and (ii) no regulatory filing or regulatory approval in the Territory with respect to the Device (other than as incorporated into a Supplied Item) or the SteadyMed Platform shall be considered Regulatory Applications or Regulatory Approvals for Supplied Items in the Field in the Territory for any purpose under this Agreement.

 

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(c)        SteadyMed will provide to Cardiome their complete dossier in a suitable format (and any supporting information) which is utilized for Regulatory Approval in the United States on or before submission in the United States. Cardiome shall (i) consult in good faith with SteadyMed in preparing applications for Regulatory Approval in the Field in the Territory; and (ii) provide SteadyMed with copies of all draft applications for Regulatory Approval in the Field in the Territory for review and comment prior to submission. Cardiome will also provide copies of all further routine regulatory submissions to SteadyMed subsequent to submission on an annual basis.

 

5.2          Further Studies for Regulatory Approval . The JSC will be responsible for reviewing any further clinical studies that may be required by a Regulatory Authority (for example, pK studies) in order to complete an application for Regulatory Approval in the Field in the Territory. If the JSC determines to proceed, then SteadyMed will pay [...***...] of the cost of such study(s).

 

5.3          Post-Approval and Reimbursement Studies . Should any Regulatory Authority in a Major Market require the conduct, after granting Regulatory Approval in such Major Market, of any clinical study of Finished Product or finished Bright Stock (with or without Finished IS) as a condition to the grant or continuing effectiveness of Regulatory Approval in such Major Market, or for reimbursement for a Finished Product or finished Bright Stock (with or without Finished IS) (a “ Post-Approval or Reimbursement Study ”), then, subject to the Parties’ mutual written approval of the protocol for such Post-Approval or Reimbursement Study and mutual written agreement on the budget for the conduct of such Post-Approval Study:

 

(a)        Cardiome shall be responsible for conducting such Post-Approval or Reimbursement Study in accordance with the requirements of such Regulatory Authority and in compliance with Applicable Laws, including, without limitation, applicable good clinical practices in effect in such Major Market;

 

(b)        the Parties shall share approve a budget through the JSC and [...***...] the cost of required clinical supply of Supplied Items for such Post-Approval or Reimbursement Study;

 

(c)        SteadyMed shall reimburse Cardiome for [...***...] of all other documented external (i.e., out-of-pocket) costs of conducting such Post-Approval or Reimbursement Study, to the extent such costs are within the approved budget;

 

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(d)        Cardiome shall prepare and deliver to SteadyMed as promptly as reasonably practicable the draft and final reports of the results of such Post-Approval or Reimbursement Study; and

 

(e)        SteadyMed shall have the right to use and disclose such results (i) in support of SteadyMed’s regulatory filings and regulatory approvals with respect to (A) Product outside the Territory or (B) the Device, Infusion Sets or the SteadyMed Platform anywhere in the world, (ii) as contemplated by the SDEA, or (ii) as otherwise required by Applicable Law.

 

For the avoidance of doubt a “Reimbursement Study” shall not include market research, pricing research, third-party payor analysis, or, similar work.

 

Except as expressly permitted above in this Section 5.2 with respect to Post-Approval or Reimbursement Studies, Cardiome and its Affiliates shall not conduct or have conducted, or permit any Sublicensee, Subdistributor or other Third Party to conduct, any clinical study of (1) Product (including, without limitation, Finished Product or Bright Stock), whether with or without Infusion set (including, without limitation, Finished IS), (2) Device, (3) Drug Product, or (4) Infusion set (including, without limitation, Finished IS). Further, in no event shall Cardiome and its Affiliates conduct or have conducted, or permit any Sublicensee, Subdistributor or other Third Party to conduct, any such clinical study.

 

5.4         Regulatory Cooperation . SteadyMed shall cooperate with any reasonable request by Cardiome for SteadyMed Know-How or other information in the possession of SteadyMed or its Affiliates that is necessary for Cardiome to file and maintain Regulatory Applications or obtain and maintain Regulatory Approvals for the Supplied Items in the Field in the Territory. Without limiting the generality of the foregoing, SteadyMed shall disclose or make available to Cardiome in a timely manner all available manufacturing and quality control data, CMC data and other information related to Supplied Items and the Manufacture thereof in the possession of SteadyMed or its Affiliates as is reasonably necessary for Cardiome to perform its obligations under this Article 5 .

 

5.5         Regulatory Communications . Cardiome shall keep SteadyMed informed of any material correspondence and communications with Regulatory Authorities in the Territory that would reasonably be expected to affect the status or scope of Regulatory Approvals for Supplied Item in the Field in the Territory.

 

5.6         Safety Reporting; Pharmacovigilance . Cardiome shall be solely responsible, at its own expense, for complying with, and shall require its Affiliates and Sublicensees to comply with, all requirements of Applicable Laws which relating to pharmacovigilance and the reporting and investigation of adverse events and product complaints with respect to the Product in the Territory. SteadyMed will be responsible at SteadyMed’s expense for conducting investigations of manufacturing elements of product complaints and issuing an investigation report as soon as reasonably possible. No later than three (3) months after the Effective Date, the Parties shall negotiate in good faith and enter into a pharmacovigilance/safety data exchange agreement for the Product (the “ SDEA ”), which shall set forth standard operating procedures governing the collection, investigation, reporting, and exchange of information concerning adverse drug reactions/experiences. The terms of the SDEA shall be no less stringent than those required by FDA, EMA and ICH guidelines and shall be sufficient to permit each Party to comply with its regulatory and legal requirements for the management and reporting of safety data regarding the Product by providing for the exchange of relevant information in appropriate format within applicable timeframes. SteadyMed shall be responsible for maintaining, at its own expense, a global safety database for the Product. In the event of a conflict between the provisions of this Agreement and the SDEA, the SDEA shall control solely with respect to the pharmacovigilance/safety data exchange obligations and responsibilities of the Parties with respect to Product, and this Agreement shall control with respect to all other matters.

 

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5.7          Threatened Agency Action . Each Party shall promptly notify the other Party’s Regulatory Affairs Department contacts designated in writing by the other Party of any information that such Party receives regarding any threatened or pending action by any Regulatory Authority that may affect the proposed labeling or Approved Labeling for a Product or Infusion set in the Field in the U.S. or any Major Market or the continued Commercialization of a Product or Infusion set in the U.S. or any Major Market. Upon receipt of any such information, each Party shall consider in good faith the other Party’s comments with respect to the appropriate action to be taken; provided , however , that nothing herein shall be construed to prevent a Party from complying with its obligations under the SDEA or with such Party’s regulatory reporting obligations under Applicable Laws.

 

5.8          Product Recalls .

 

(a)        In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with a Supplied Item in the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a Supplied Item recall or market withdrawal in the Territory, the Party notified of or desiring such recall or similar action shall, within 24 hours, advise the other Party thereof by telephone (confirmed by email or facsimile), email or facsimile. The Parties shall, to the extent practicable, endeavor to discuss and agree upon whether to recall or withdraw such Supplied Item in the Territory; provided that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing the exigencies of the situation), then such recall or withdrawal shall be undertaken. If any Regulatory Authority issues or requests a recall or takes similar action in connection with a Supplied Item in the Territory, or a Party decides that a recall or withdrawal of a Supplied Item in the Territory is necessary, Cardiome shall be responsible for conducting such recall or withdrawal in the Territory in accordance with Applicable Law, the requirements of the applicable Regulatory Authority, and SteadyMed’s instructions. The costs of conducting such recall or withdrawal shall be allocated as set forth below in Section 5.8(b) . To the extent that it is necessary or appropriate to communicate with any person in the Territory, including any Regulatory Authority, the media or any customer, concerning any recall, withdrawal, other remedial action, event, incidence or circumstance concerning a Supplied Item in the Territory, as between the Parties, Cardiome shall be responsible for such communication.

 

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(b)        Any recall conducted, or required to be conducted, by Cardiome with respect to a Supplied Item in the Territory will be conducted at Cardiome’s sole cost and expense, unless the fact or circumstance giving rise to the need to conduct such recall was proximately caused in whole or in part by a breach of, or non-compliance with, this Agreement or the Quality Agreement by SteadyMed or by both Parties (such breach or non-compliance, a “ Fault ”; and the Party(ies) at Fault, the “ At-Fault Party(ies) ”). If Cardiome believes in good faith that SteadyMed is at Fault, Cardiome shall notify SteadyMed in writing thereof as soon as possible after Cardiome first receives notice or otherwise becomes aware that such recall is required, and if SteadyMed believes in good faith that Cardiome is at Fault, SteadyMed shall so notify Cardiome as soon as possible after receipt of notice from Cardiome. Within [...***...] after SteadyMed’s receipt of notice from Cardiome, the Parties will attempt in good faith to reach mutual written agreement as to the relative Fault (if any) of each Party in causing the fact or circumstance giving rise to such recall and as to how the associated costs and expenses should be borne by the Parties. If the Parties are unable to reach mutual written agreement within an additional [...***...], then the Parties shall mutually select an independent expert with at least [...***...] of industry experience with recalls of pharmaceutical products to determine whether or not one or both of the Parties is/are at Fault and, if so, to assess the relative Fault (if any) of the At-Fault Party(ies). SteadyMed and Cardiome shall promptly respond to the independent expert’s requests for information that the independent expert deems necessary to make his/her determination. The determination of the independent expert will be binding on the Parties. Responsibility for the costs and expenses incurred by Cardiome in conducting a recall of Supplied Item and the fees and costs of the independent expert shall be allocated as set forth below:

 

(i)        If the independent expert determines that neither Party is at Fault or that only Cardiome is at Fault, then Cardiome shall be solely responsible for the costs and expenses of conducting such recall and for the fees and costs of the independent expert.

 

(ii)        If the independent expert determines that both Parties are at Fault, then the reasonable and documented out-of-pocket (i.e., external) costs and expenses incurred by Cardiome in conducting the recall and the fees and costs of the independent expert shall be shared by the Parties in proportion to their relative Fault as determined by the independent expert.

 

(iii)        If the independent expert determines that only SteadyMed is at Fault, then the reasonable and documented out-of-pocket (i.e., external) costs and expenses incurred by Cardiome in conducting the recall and the fees and costs of the independent expert shall be borne entirely by SteadyMed.

 

Article 6

 

COMMERCIALIZATION

 

6.1         Commercialization Responsibility . Cardiome shall be solely responsible for Commercializing, at Cardiome’s sole expense, and has the exclusive right to Commercialize, the Product in the Field in the Territory, subject to the terms and conditions of this Agreement.

 

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6.2         Commercialization Plan . No later than 12 months prior to the anticipated Launch Date, Cardiome shall prepare and deliver to SteadyMed for review a reasonably detailed written plan for the Commercialization of the Product in the Territory during the period beginning six (6) months prior to the anticipated Launch Date and ending on the fifth (5th) anniversary thereof (the “ Commercialization Plan ”). The Commercialization Plan shall include information regarding planned Commercialization activities for Supplied Item in the Territory, including, without limitation, pre-launch activities, establishment of government or private payor and reimbursement capabilities and pharmaceutical logistics capabilities, supply and inventory-related activities, Promotion, anticipated number and geographic distribution/coverage of Sales Representatives by country, and Sales Force and tactical marketing activities (such as market research to develop Product positioning key messages). Cardiome may amend or update the Commercialization Plan from time to time to reflect changes in Cardiome’s Commercialization plans, and shall in any event provide SteadyMed with annual updates to the Commercialization Plan, in each case, subject to the requirements of this Article 6 . SteadyMed may provide comments and suggestions regarding the Commercialization Plan and any amendment or update thereto to Cardiome, and Cardiome agrees to consider such comments and suggestions in good faith. As used herein, the term “ Commercialization Plan ” means the version of the Commercialization Plan most recently provided by Cardiome to SteadyMed. Cardiome shall deliver annual written reports to SteadyMed of the Commercialization activities and efforts conducted by or on behalf of Cardiome and its Affiliates for Supplied Item in the Territory during each Quarter, which shall include such detail regarding the matters described in Sections 3.2(c) , and Sections 3.2(c) through 3.2(g) , as the JSC may request or require or as may be reasonably required for SteadyMed to assess Cardiome’s compliance with its obligations under Sections 6.3 and 6.4 .

 

6.3         Commercialization Diligence . Subject to Cardiome’s receipt of access to a complete electronic copy of SteadyMed’s New Drug Application for Product and Infusion set in the Field as filed with the FDA and the required stability data for Product described below in this Section 6.3 , Cardiome shall use Commercially Reasonable Efforts: (a) to obtain and maintain Regulatory Approvals in at least the Major Markets; (b) to obtain and maintain required Pricing Approvals in at least the Major Markets; (c) to initiate commercial sale of Supplied Items in each Major Market within six (6) months after receipt of Regulatory Approval and any required Pricing Approvals in such Major Market, and thereafter to Commercialize, and maximize Net Sales of, Supplied Items in the Field in such Major Market; and (d) otherwise to conduct material Commercialization Plan activities substantially in accordance with the timeline set forth in the Commercialization Plan. Without limiting the generality of the foregoing, no later than six (6) months after the later of (i) Cardiome’s receipt of access to a complete electronic copy of SteadyMed’s New Drug Application for Product as filed with the FDA and (ii) Cardiome’s receipt from SteadyMed of 12 months of stability data for Product, Cardiome shall file a Regulatory Application with each of the EMA and the applicable national Regulatory Authority in Canada. For clarity, SteadyMed shall be solely responsible for conducting the activities necessary to generate 12 months of stability data for Product, at SteadyMed’s sole cost.

 

6.4         Pricing Approvals; Reimbursement Efforts . Cardiome shall be solely responsible for obtaining and maintaining Pricing Approvals for Supplied Items in the Field in the Territory and reimbursement status for Supplied Items in the Field in the Territory from key governmental and non-governmental payors in the Territory, in each case, at Cardiome’s sole expense. Cardiome and its Affiliates shall use Commercially Reasonable Efforts to obtain Pricing Approvals and reimbursement status for Supplied Items in the Field in at least the Major Markets. Without limiting the generality of the foregoing, Cardiome shall have retained a qualified reimbursement consultant (or have established internal reimbursement expertise and capability) for Supplied Items in the Territory no later than the first filing of a Regulatory Application with the applicable Regulatory Authority in the first Major Market. Cardiome shall keep SteadyMed regularly informed of the status of its efforts to obtain and maintain such Pricing Approvals and reimbursement status.

 

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6.5          Terms of Sale . The Parties acknowledge and agree that Cardiome will be solely responsible for establishing all terms of commercial sale of Supplied Items in the Territory (including the price(s) at which Supplied Items will be sold).

 

6.6          Product Returns . Cardiome shall have the sole responsibility for processing Supplied Item returns in the Territory.

 

6.7          Non-Compete . Neither Cardiome nor any of its Affiliates shall directly or indirectly Commercialize any Competing Product in the Territory during the Term.

 

6.8          Promotional Materials; Product Labels and Inserts .

 

(a)        Cardiome shall provide SteadyMed with samples of all proposed Promotional Materials proposed to be used in the Territory, and shall obtain SteadyMed’s approval of the form and content of such Promotional Materials prior to the first use or distribution thereof anywhere in the Territory. Upon Cardiome’s reasonable request, SteadyMed shall provide Cardiome with samples of appropriate (as determined by SteadyMed in good faith) promotional materials for Products and Infusion sets used by SteadyMed outside the Territory solely to assist Cardiome in developing Promotional Materials for the Territory, subject to SteadyMed’s approval as set forth above. Cardiome shall be solely responsible for verifying and ensuring that all Promotional Materials used in any country of the Territory comply with Commercialization Standards and Applicable Laws in such country, and for translating, and ensuring the accuracy of any translation, of such Promotional Materials into other languages; in each case, at Cardiome’s sole cost. Cardiome warrants and represents that all Promotional Materials shall be in compliance with all Applicable Laws at the time they are used. In the event that any of the Promotional Materials is found to be not in compliance with Applicable Laws, Cardiome shall immediately cease using and distributing such non-compliant Promotional Materials and shall alter or amend the Promotional Materials to ensure compliance.

 

(b)        Cardiome shall be solely responsible for ensuring that the Product Labeling and Inserts to be used in the Manufacture of Supplied Items for any country of the Territory, which Cardiome shall provide to SteadyMed or the applicable Contract Manufacturer for use in the Manufacture of such Supplied Item: (i) conforms strictly to the Approved Labeling for such Supplied Item in such country; and (ii) otherwise complies to Applicable Laws in such country; in each case, at Cardiome’s sole cost. Cardiome shall also be solely responsible for all translation, and ensuring the accuracy of translation, of Product Labels and Inserts into any other language; in each case, at Cardiome’s sole cost. For the avoidance of doubt, the manufacturing costs related to the production of the Product Labeling and Inserts should be paid by SteadyMed, but considered part of COGS.

 

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(c)        SteadyMed shall own all right, title and interest in and to all Promotional Materials and Product Labels and Inserts, in each case including all content contained therein, all Copyrights therein and all SteadyMed Trademarks contained therein (but excluding any Cardiome House Marks contained therein). To the extent Cardiome (or any of its Affiliates, Sublicensees or other agents) obtains or otherwise has a claim to any of the foregoing, Cardiome shall assign, and hereby does assign, to SteadyMed all of Cardiome’s (and its Affiliates’, Sublicensees’ and other agents’) right, title and interest in and to such Promotional Materials and Product Labels and Inserts, in each case including all content contained therein, all Copyrights therein and all SteadyMed Trademarks contained therein (but excluding any Cardiome House Marks).

 

(d)        Except for the use of the SteadyMed House Marks and Cardiome House Marks in Promotional Materials and Product Labels and Inserts as expressly permitted by this Agreement, Cardiome shall Promote Product and Infusion set in the Territory only under the Product Marks.

 

(e)        Subject to the terms and conditions of this Agreement, including, without limitation, Section 11.7 and the preceding provisions of this Section 6.8 , SteadyMed hereby grants to Cardiome during the Term: (i) a non-exclusive, royalty-free license to use and display the SteadyMed Trademarks on Promotional Materials and Product Labels and Inserts, in each case, solely in connection with the Commercialization of Supplied Items in the Field in the Territory in accordance with this Agreement; and (ii) a non-exclusive, royalty-free license under SteadyMed’s Copyrights in the Promotional Materials and Product Labels and Inserts, to copy, use, distribute and publicly display Promotional Materials and Product Labels and Inserts, in each case, solely connection with the Commercialization of Supplied Items in the Field in the Territory in accordance with this Agreement. The foregoing licenses are non-transferable and non-assignable (except as expressly set forth in Section 15.6 ), and Cardiome shall have the right to grant sublicenses under the foregoing licenses solely in conjunction with the grant of a Sublicense in accordance with Section 2.3 . The licenses granted under this Section 6.8(e) , including all sublicenses granted thereunder, shall automatically terminate upon the expiration or termination of this Agreement. In addition, SteadyMed may terminate the SteadyMed Trademark license if, in SteadyMed’s reasonable discretion, Cardiome’s use of any SteadyMed Trademark tarnishes, blurs or dilutes the quality associated with such SteadyMed Trademarks or the associated goodwill and such unauthorized use is not cured within [...***...] of notice of breach.

 

(f)         Requests for Medical Information . Cardiome shall have the exclusive right and responsibility to respond to all questions and requests for information regarding Product received by the Sales Force or any MSL from prescribers or health care providers in the Territory in accordance with Commercialization Standards and Applicable Laws.

 

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6.9           Compliance with Laws and Policies .

 

(a)        Cardiome and its Affiliates shall comply, and shall require Sublicensees and Permitted Subdistributors to comply, with: (i) all Applicable Laws in Commercializing the Products in the Territory, including Anti-Corruption Laws; the EU Data Protection Directive 95/46/EC, other Applicable Laws concerning data privacy and data protection, and any applicable national legislation enacted thereunder; supranational, national, regional and local insurance “fraud and abuse,” consumer protection and false claims statutes and regulations, any other mandatory corporate governance laws; (ii) the Cardiome Code of Business Conduct and Ethics; and (iii) applicable industry codes and guidelines concerning the advertising or promotion of prescription medicines in the Territory, including the EFPIA HCP Code (EFPIA code on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals), the EFPIA HCP/HCO Code (EFPIA code on Disclosures of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organizations), other applicable EFPIA codes, and equivalents thereof in the Territory (collectively, “ Commercialization Standards ”). Cardiome and its Affiliates that are involved in Commercializing the Product in the Territory shall establish, and maintain throughout the Term, adequate procedures to support compliance with the Commercialization Standards and shall promptly notify SteadyMed in writing of any material non-compliance with the Commercialization Standards by Cardiome and its Affiliates, Sublicensees and Permitted Subdistributors, or any Sales Representative or other Representative of any of them.

 

(b)        Cardiome shall ensure that all Sales Representatives promoting Supplied Items in the Territory (i) have skills, training and experience consistent with industry standards applicable to the promotion, marketing and sale of a prescription pharmaceutical product, (ii) have satisfactorily completed all training required by this Agreement and (iii) are adequately equipped and knowledgeable with respect to the Supplied Items.

 

(c)        Cardiome shall not, and shall ensure that its Affiliates and Sublicensees and its and their respective Sales Representatives, sales managers, MSLs and contract sales forces shall not: (i) make any statement, representation or warranty, oral or written, concerning any Supplied Item, or use any Promotional Material, that is inconsistent with, or contrary to, the Approved Labeling in the applicable country of the Territory or in violation of any Applicable Laws; or (ii) make any arrangements with, make payments to or provide gifts or other incentives to any healthcare professionals in violation of Applicable Laws relating thereto. Cardiome shall ensure that all such Sales Representatives, sales managers, MSLs and contract sales forces are familiar with the procedures, obligations, rights, and responsibilities imposed by the terms of this Agreement as applicable to the performance of Promotional activities hereunder.

 

6.10         Training Programs .

 

(a)        Prior to Launch, SteadyMed shall provide [...***...] of mutually-agreed initial training, at a single location, to the Sales Force, sales managers and/or medical directors of Cardiome and its Affiliates with respect to: (i) pulmonary arterial hypertension, (ii) Product knowledge, (iii) competitive Product knowledge, (iv) reporting of adverse events and product complaints in accordance with the terms of the SDEA, and (v) use of any Promotional Materials provided by SteadyMed (collectively, the “ Initial Sales Force Training ”). SteadyMed shall provide Cardiome with a copy of all training materials to be used by SteadyMed in the Initial Sales Force Training reasonably in advance of such training for review. For clarity, SteadyMed shall have no responsibility for training the Sales Force, sales managers and/or medical directors of Cardiome and its Affiliates with respect to compliance with Applicable Laws in the Territory.

 

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(b)        The Initial Sales Force Training will be conducted, and all training materials provided by SteadyMed to Cardiome shall be prepared, in English. Cardiome shall be responsible for any required translation of the Initial Sales Force Training and any training materials provided by SteadyMed.

 

(c)        Except for the Initial Sales Force Training, both before and after Launch, Cardiome shall provide training to the Sales Force, sales managers and/or medical directors of Cardiome and its Affiliates with respect to: (i) compliance with the Commercialization Standards and other Applicable Laws in the Territory; (ii) all subject matter covered by the Initial Sales Force Training and any training materials provided by SteadyMed; and (iii) compliance with any other Applicable Laws in the Territory or any portion thereof pertaining to the Commercialization of Supplied Items (or pharmaceutical products generally).

 

Article 7

 

FINANCIAL TERMS OF LICENSE

 

7.1          One-Time Exclusivity Fee . Cardiome (or an Affiliate) will pay to SteadyMed a one-time, non-refundable, non-creditable license fee in the amount of $3,000,000 within [...***...] of the Effective Date.

 

7.2          One-Time Regulatory Milestones . Cardiome (or an Affiliate) shall pay to SteadyMed each of the following one-time, non-refundable, non-creditable milestone payments within [...***...] after the first achievement (whether by Cardiome or any of its Affiliates or Sublicensees) of the corresponding milestone event by a Product:

Regulatory Milestone Event   Milestone
Payment
     
First Regulatory Approval for Product in the Field either (i) by EMA if the centralized European Union filing procedure is used or (i) by the applicable Regulatory Authority in the first Major Market in Europe if the centralized European Union filing procedure is not used, whichever occurs first   [...***...]
     
Regulatory Approval for Product in the Field in Canada   [...***...]
     
Receipt of Pricing Approval for Product in the United Kingdom   [...***...]
     
Receipt of Pricing Approval for Product in Italy   [...***...]
     
Receipt of Pricing Approval for Product in France   [...***...]
     
Receipt of Pricing Approval for Product in Germany   [...***...]
     
Receipt of Pricing Approval for Product in Canada   [...***...]

 

Each of the milestone payments above shall be payable only one time, for the first achievement by any Product of the applicable milestone event.

 

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7.3          One-Time Cumulative Net Sales Milestone . Cardiome (or an Affiliate) shall pay to SteadyMed a one-time, non-refundable, non-creditable milestone payment of [...***...] within [...***...] in which cumulative Net Sales of all Supplied Items by Cardiome, its Affiliates and Sublicensees in the Territory since the Launch Date equal or exceed [...***...] in the aggregate. The foregoing milestone payment shall be payable only one time, for the first achievement of the foregoing milestone.

 

7.4          Royalties . Cardiome (or an Affiliate) shall pay royalties to SteadyMed on the aggregate annual Royalty Base for sales of all Supplied Items by Cardiome, its Affiliates and Sublicensees in each Year at the applicable rate(s) set forth below:

Annual Royalty Base Increments   Royalty Rate
     
That portion of the aggregate annual Royalty Base for sales of all Supplied Items by Cardiome, its Affiliates and Sublicensees in a Year that is less than or equal to [...***...]   [...***...]
     
That portion of aggregate annual Royalty Base for sales of all Supplied Items by Cardiome, its Affiliates and Sublicensees in such Year that is greater than [...***...] and less than or equal to [...***...]   [...***...]
     
That portion of aggregate annual Royalty Base for sales of Products by Cardiome, its Affiliates and Sublicensees in such Year that is greater than [...***...]   [...***...]

 

Article 8


PAYMENTS; RECORDS; AUDITS

 

8.1          Payment; Reports . Royalties under Section 7.4 shall be reported and paid as follows:

 

(a)        Cardiome will provide a written royalty estimate within [...***...] after the end of each Quarter; and

 

(b)        Cardiome will provide a final written royalty report and the quarterly royalty payment within [...***...] after the end of the Quarter. Each payment of royalties shall be accompanied by a report of the Royalty Base for such Quarter, in sufficient detail to permit confirmation of the accuracy of the payment made, including: (a) [...***...], (i) gross sales, (ii) Net Sales, (iii) [...***...], (iv) the Royalty Base, (v) Transfer Price (determined in accordance with the definition of Royalty Base), (vi) Average Net Selling Price, (vii) Average Transfer Price, and (viii) the Cardiome Margin (b) the royalty payable; and (c) the exchange rates used.

 

8.2         Exchange Rate; Manner and Place of Payment . All payment amounts in this Agreement are expressed in U.S. dollars, and all payments hereunder shall be payable in U.S. dollars. When conversion of payments from any foreign currency is required, such conversion shall be calculated using an exchange rate equal to the average of the interbank rates of exchange for such currency as reported at OANDA.com during the Quarter for which payment is due. All payments owed under this Agreement shall be made by wire transfer in immediately available funds to the bank and account designated in writing by SteadyMed.

 

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8.3          Income Tax Withholding . SteadyMed shall pay any and all taxes levied on account of any payments made to it under this Agreement. If any taxes are required to be withheld by Cardiome from any payment made to SteadyMed under this Agreement, Cardiome shall (a) deduct such taxes from the payment made to SteadyMed, (b) timely pay the taxes to the proper taxing authority, (c) send proof of payment to SteadyMed and certify its receipt by the taxing authority within [...***...] following such payment, and (d) cooperate with SteadyMed in any way reasonably requested by SteadyMed to obtain available reductions, credits or refunds of such taxes. Without limiting the generality of the foregoing, upon request by SteadyMed, Cardiome shall provide SteadyMed such information in Cardiome’s possession as may be reasonably necessary for SteadyMed to obtain the benefit of any present or future treaty against double taxation which may apply to payments made to SteadyMed under this Agreement.

 

8.4          Records . Each Party shall keep, or shall cause to be kept, for a period of [...***...] after the expiration or termination hereof or such longer period as required by Applicable Law, complete and accurate books and records (financial and otherwise) pertaining to the performance of its obligations hereunder, to the extent such information is tracked by such Party.

 

8.5          Compliance Audits . Each Party shall maintain complete and accurate books and records relating to its compliance with Applicable Law, and their Policies and the Compliance Provisions (AB/AC) (collectively, the “ Compliance Records ”) with respect to its obligations under this Agreement for a period of [...***...] after the period to which such records relate or such longer period as required by Applicable Law, which Compliance Records shall include: (a) its policies and procedures concerning compliance with Applicable Law, (b) records of any investigations and remedial and disciplinary actions taken to address material violations of Applicable Law, and (c) records of any payments made in connection with this Agreement.

 

8.6          Audits .

 

(a)         By SteadyMed . Cardiome shall keep, and shall cause its Affiliates and Sublicensees to keep, complete and accurate records pertaining to the purchase and sale or other disposition of Supplied Items in sufficient detail to permit SteadyMed to confirm the accuracy of all royalty payments due hereunder for at least [...***...] following the end of the Year to which they pertain. SteadyMed shall have the right, once annually, to cause an independent, certified public accountant reasonably acceptable to Cardiome to audit such records solely to confirm the Royalty Base and royalties for a period covering not more than the preceding [...***...]. No Year shall be subject to audit under this Section 8.6(a) more than once, except in the event of a restatement by Cardiome of its audited financial statements for such Year. Such audits may be exercised during normal business hours upon reasonable prior written notice of not less than [...***...] to Cardiome in the location where the records are maintained. The auditor shall execute a reasonable written confidentiality agreement with Cardiome and shall disclose to SteadyMed only such information as is reasonably necessary to provide SteadyMed with information regarding any actual or potential discrepancies between amounts reported and actually paid and amounts payable under this Agreement. The auditor shall send a copy of the report to Cardiome at the same time it is sent to SteadyMed. The report sent to both parties shall include the methodology and calculations used to determine the results. Prompt adjustments shall be made by the parties to reflect the results of such audit. SteadyMed shall bear the full cost of such audit unless such audit discloses an underpayment by Cardiome of more than [...***...] of the amount due for any Year under this Agreement, in which case, Cardiome shall bear the full cost of such audit and shall promptly remit to SteadyMed the amount of any underpayment. If such audit discloses an overpayment by Cardiome, then Cardiome shall deduct the amount of such overpayment from amounts otherwise owed to SteadyMed under this Agreement.

 

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(b)         By Cardiome . SteadyMed shall keep, and shall cause its Affiliates and Sublicensees to keep, complete and accurate records pertaining to the Manufacture of Supplied Items in sufficient detail to permit Cardiome to confirm the accuracy of the COGS reported by SteadyMed in invoices for Supplied Items hereunder for at least [...***...] following the end of the Year to which they pertain. Cardiome shall have the right, once annually, to cause an independent, certified public accountant reasonably acceptable to SteadyMed to audit such records solely to confirm the COGS reported by SteadyMed in invoices for Supplied Items for a period covering not more than the preceding [...***...], and to confirm the COGS of similar Supplied Items destined for the United States market, in reference to Section 4.5 . No Year shall be subject to audit under this Section 8.6(b) more than once, except in the event of a restatement by SteadyMed of its audited financial statements for such Year. Such audits may be exercised during normal business hours upon reasonable prior written notice of not less than [...***...] to SteadyMed in the location where the records are maintained. The auditor shall execute a reasonable written confidentiality agreement with SteadyMed and shall disclose to Cardiome only such information as is reasonably necessary to provide Cardiome with information regarding any actual or potential discrepancies between the COGS reported and actual COGS that resulted Cardiome’s payment of inaccurately-calculated Transfer Price(s) for Supplied Item(s) under this Agreement. The auditor shall send a copy of the report to SteadyMed at the same time it is sent to Cardiome. The report sent to both parties shall include the methodology and calculations used to determine the results. Prompt adjustments shall be made by the parties to reflect the results of such audit. Cardiome shall bear the full cost of such audit unless such audit discloses an overstatement of the aggregate COGS of all Supplied Items supplied by SteadyMed of more than [...***...] of the aggregate actual COGS of such Supplied Items for any Year under this Agreement, in which case, SteadyMed shall bear the full cost of such audit and shall promptly issue a credit to Cardiome in the amount of the overstatement.

 

8.7         Late Payments . In the event that any payment due under this Agreement (including but not limited to Sections 8.5 and 8.6 above) is not made when due, the payment shall accrue interest at a rate equal to [...***...] for the period from the due date for payment until the date of actual payment. The payment of such interest shall not limit any Party to this Agreement from exercising any other rights it may have as a consequence of the lateness of any payment.

 

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Article 9

 

BUSINESS ETHICS

 

9.1         Compliance Program . Each Party shall maintain, implement and enforce an anti-bribery/anti-corruption (“ AB/AC ”) compliance program to ensure compliance by such Party, its Affiliates, and its and their respective Representatives with applicable Anti-Corruption Laws in connection with the matters that are the subject of this Agreement or the performance of its obligations hereunder. In addition, Cardiome shall require each Sublicensee, Permitted Subdistributor or other Third Party engaged after the Effective Date to Promote the Product in the Territory to maintain, implement and enforce an AB/AC compliance program to ensure compliance, mutatis mutandis , by such Sublicensee, Permitted Subdistributor or other Third Party, their respective affiliates, and their respective officers, directors, employees, agents and representatives with applicable Anti-Corruption Laws in connection with the matters that are the subject of this Agreement or the performance of its obligations hereunder.

 

9.2         Compliance Certificate . Each Party shall, at the written request of the other Party no more than once per Year, deliver to the other Party a certificate executed by an authorized officer of the delivering Party certifying compliance by such Party, its Affiliates, and its and their respective Representatives with applicable Anti-Corruption Laws in connection with the matters that are the subject of this Agreement or the performance of its obligations hereunder.

 

Article 10

 

CONFIDENTIALITY

 

10.1         Confidential Information . Except to the extent expressly authorized by this Agreement, the Receiving Party agrees that, at all times during the Term and for [...***...] following the expiration or termination hereof, the Receiving Party (i) shall keep completely confidential and shall not publish or otherwise disclose any Confidential Information furnished to it by the Disclosing Party, except to those Representatives of the Receiving Party and its Affiliates who have a need to know such information to perform the Receiving Party’s obligations hereunder (and who shall be advised of the Receiving Party’s obligations hereunder and who are bound by confidentiality obligations with respect to such Confidential Information no less onerous than those set forth in this Agreement) and (ii) shall not use any Confidential Information of the Disclosing Party directly or indirectly for any purpose other than performing its obligations hereunder.

 

Exceptions to Confidentiality . The Receiving Party’s obligations set forth in this Agreement shall not extend to any Confidential Information of the Disclosing Party that the Receiving Party can establish by competent evidence: (a) is now, or hereafter becomes, through no act or failure to act on the part of the Receiving Party, generally known or available; (b) is known by the Receiving Party and/or any of its Affiliates at the time of receiving such information, as evidenced by its records; (c) is hereafter furnished to the Receiving Party and/or any of its Affiliates by a Third Party, as a matter of right and without restriction on disclosure; or (d) is independently discovered or developed by the Receiving Party and/or any of its Affiliates, without the aid, use or application of any Confidential Information of the Disclosing Party.

 

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10.2         Authorized Disclosure . Notwithstanding the provisions of Section 10.1 , the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:

 

(a)        filing or prosecuting Patents as permitted by this Agreement;

 

(b)        enforcing such Party’s rights and performing its obligations under this Agreement;

 

(c)        prosecuting or defending litigation as permitted by this Agreement;

 

(d)        complying with applicable court orders, applicable laws, rules or regulations, or the listing rules of any exchange on which the Receiving Party’s securities are traded;

 

(e)        in the case of Cardiome, disclosure to actual and potential Sublicensees, Permitted Subdistributors and other Third Party contractors of Cardiome and its Affiliates, who, in each case, have a need to know such information in order for Cardiome to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Person agrees to be bound by terms of confidentiality and non-use comparable in scope to those set forth in this Article 10 ;

 

(f)        in the case of SteadyMed, the Contract Manufacturers, actual and potential licensees and sublicensees of SteadyMed’s retained or reserved rights hereunder, and actual and potential Third Party contractors of SteadyMed or its Affiliates who have a need to know such information in order for SteadyMed to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Person agrees to be bound by terms of confidentiality and non-use comparable in scope to those set forth in this Article 10 ; and

 

(g)        disclosure to Third Parties in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential Third Party investors, lenders or other financing sources in confidential financing documents, provided, in each case, that any such Third Party agrees to be bound by reasonable obligations of confidentiality and non-use.

 

Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 10.2 (c) or 10.2 (d), it will, except where impracticable, give reasonable advance notice to the Disclosing Party of such disclosure and use efforts to secure confidential treatment of such information at least as diligent as the Receiving Party would use to protect its own confidential information, but in no event less than reasonable efforts. In any event, the Receiving Party agrees to take all reasonable action to avoid disclosure of Confidential Information hereunder.

 

10.3         Notification . The Receiving Party shall notify the Disclosing Party promptly, and cooperate with the Disclosing Party as the Disclosing Party may reasonably request, upon the Receiving Party’s discovery of any loss or compromise of the Disclosing Party’s Confidential Information.

 

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10.4         Remedies . Each Party acknowledges that the failure by the Receiving Party to comply with any of the provisions of this Article 10 may result in irreparable injury and continuing damage to the Disclosing Party such that no remedy at law may adequately protect or appropriately compensate the Disclosing Party for such injury, and that, in the event of any such failure, the Disclosing Party shall be entitled to seek enforcement of this Article 10 and any of its provisions by injunction, specific performance or other equitable relief, without prejudice to any other rights and remedies that the Disclosing Party may have for a breach of this Article 10 .

 

10.5         Publicity .

 

(a)         Press Releases . No later than one (1) business day following the Effective Date, the Parties shall issue a joint press release announcing the execution of this Agreement in substantially the form attached hereto as Schedule 10.5 . It is further acknowledged that each Party may desire or be required to issue subsequent press releases relating to this Agreement or activities hereunder. The Parties agree to consult with each other reasonably and in good faith with respect to the text and timing of subsequent press releases prior to the issuance thereof, provided that a Party may not withhold consent to such releases that the other Party may determine, based on advice of counsel, are reasonably necessary to comply with applicable law, including disclosure requirements of the U.S. Securities and Exchange Commission, or with the requirements of any stock exchange on which securities issued by a Party or its Affiliates are traded. In the event of a required public announcement, to the extent practicable under the circumstances, the Party making such announcement shall provide the other Party with a copy of the proposed text of such announcement sufficiently in advance of the scheduled release to afford such other Party a reasonable opportunity to review and comment upon the proposed text. Each Party may make public statements regarding this Agreement in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst calls, or issue press releases, so long as any such public statement or press release is not inconsistent with prior public disclosures or public statements approved by the other Party pursuant to this Section 10.5 or permitted by Section 10.2 and does not reveal non-public information about the other Party.

 

(b)         Filing of this Agreement . The Parties shall coordinate in advance with each other in connection with the filing of this Agreement (including redaction of certain provisions of this Agreement) with any securities authority or with any stock exchange on which securities issued by a Party or its Affiliate are traded, and each Party will use reasonable efforts to seek confidential treatment for the terms proposed to be redacted; provided that each Party will ultimately retain control over what information to disclose to any securities authority or stock exchange, as the case may be, and provided further that the Parties will use their reasonable efforts to file redacted versions with any governing bodies which are consistent with redacted versions previously filed with any other governing bodies. Other than such obligation, neither Party (nor any of its Affiliates) will be obligated to consult with or obtain approval from the other Party with respect to any filings to any securities authority or stock exchange.

 

10.6         Prior Non-Disclosure Agreements . As of the Effective Date, the terms of this Article 10 shall supersede any prior non-disclosure, secrecy or confidentiality agreement between the Parties (or their Affiliates) dealing with the subject of this Agreement, including the Confidentiality Agreement. Any information disclosed by a Party pursuant to any such prior agreement shall be deemed Confidential Information of such Party for purposes of this Agreement.

 

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Article 11

 

INTELLECTUAL PROPERTY

 

11.1         Ownership of SteadyMed Technology . SteadyMed shall at all times be and remain the sole and exclusive owner of all SteadyMed Technology.

 

11.2         Ownership of Inventions . Inventorship of all Inventions shall be determined on a worldwide basis in accordance with U.S. patent laws. As between the Parties, ownership of Inventions shall be determined as follows:

 

(a)        Any Invention, excluding any Improvement, that is made solely by one or more employees, consultants or contractors of a Party or any of its Affiliates (each, a “ Sole Invention ”) shall be owned solely by such Party. Cardiome hereby grants to SteadyMed a non-exclusive, royalty-free, fully-paid, irrevocable, perpetual license, including the right to sublicense through multiple tiers, under Patents and other intellectual property rights Controlled by Cardiome or any of its Affiliates that claim any Sole Invention owned by Cardiome and/or any of its Affiliates, solely: (i) to research, develop, make, have made, use, sell, have sold, offer for sale, import and Commercialize Product (including, without limitation, Finished Product) and Infusion set (including, without limitation, Finished IS) outside the Territory; (ii) to make and have made Product (including, without limitation, Finished Product) and Infusion set (including, without limitation, Finished IS) in the Territory solely for the purpose of Commercialization outside the Territory; and (iii) to make, have made, use, sell, have sold, offer for sale, import and Commercialize API, Drug Product, Device, any Device component or Infusion set throughout the world, except for sale, offer for sale, import and Commercialization of any of the foregoing as incorporated in Finished Product or Finished IS, as applicable, in the Field in the Territory

 

(b)        Any Invention, other than an Improvement, that is made jointly by one or more employees, consultants or contractors of Cardiome or any of its Affiliates, and one or more employees, consultants or contractors of SteadyMed or any of its Affiliates (each, a “ Joint Invention ”), shall be owned jointly by the Parties, and each Party, on behalf of itself and its Affiliates, hereby assigns to the other Party an undivided one-half ownership interest in and to all Joint Inventions. Each Party shall ensure that its and its Affiliates’ respective employees, consultants and contractors are bound by written agreement to assign to such Party all right, title and interest in and to all Joint Inventions as necessary for such Party to comply with its assignment obligations under this Section. Each Party and its Affiliates shall, promptly upon request by the other Party, execute and deliver, and shall require its and their respective employees, consultants and contractors to execute and deliver, such papers and instruments as are necessary to effectuate the ownership of Joint Inventions set forth in this Section (including Patents claiming Joint Inventions).

 

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(c)        Any Improvement, regardless of the inventorship thereof, shall be owned solely by SteadyMed, and Cardiome, on behalf of itself and its Affiliates, hereby assigns to SteadyMed all right, title and interest in and to all Improvements. Cardiome shall ensure that its and its Affiliates’ respective employees, consultants and contractors are bound by written agreement to assign to Cardiome all right, title and interest in and to all Improvements as necessary for Cardiome to comply with its assignment obligations under this Section. Promptly upon request by SteadyMed, Cardiome and its Affiliates shall execute and deliver, and shall require its and their respective employees, consultants and contractors to execute and deliver, such papers and instruments as are necessary to effectuate the ownership of Improvements set forth in this Section (including Patents claiming Improvements).

 

11.3         Patent Prosecution and Maintenance . SteadyMed shall have the sole right, but not the obligation, to prepare, file, prosecute and maintain all SteadyMed Patents, at SteadyMed’s sole expense.

 

11.4         Enforcement .

 

(a)         Notice . Each Party shall promptly notify the other Party of any alleged or actual infringement of any SteadyMed Patent in the Territory of which it becomes aware.

 

(b)         SteadyMed Patents .

 

(i)         Enforcement of SteadyMed Patents Generally . Except as expressly set in Section 11.4(c) , SteadyMed shall have the sole right, but not the obligation, to bring and control any action or proceeding against a Third Party for infringement of any SteadyMed Patent in the Territory, at its own expense and by counsel of its own choice.

 

(c)         Competitive Infringement of Product-Specific Patent . Solely in the case of infringement of a Product-Specific Patent in the Field in a country of the Territory and only to the extent that the applicable infringing activity is competitive with Product in the Field in such country (“ Competitive Infringement ”), SteadyMed shall have the first right, but not the obligation, to bring and control any action or proceeding against a Third Party for infringement of such Product-Specific Patent in the Field in such country, at its own expense and by counsel of its own choice. If SteadyMed decides that it does not wish to bring any such action or proceeding, or SteadyMed has not brought any such action or proceeding by the date that is [...***...] before the time limit, if any, set forth in the appropriate laws and regulations for the filing of such actions, whichever comes first, then Cardiome shall have the right, but not the obligation, to bring and control any such action or proceeding to enforce such Product-Specific Patent in such country solely with respect to such Competitive Infringement, at its own expense and by counsel of its own choice, and SteadyMed shall have the right, but not the obligation, at its own expense, to be represented in any such action by counsel of its own choice.

 

(d)         Cooperation; Recoveries . In the event a Party brings an infringement action or proceeding in accordance with Section 11.4(b) , the other Party shall cooperate fully, including, if required to bring such action, the furnishing of a power of attorney or being named as a party. Neither Party shall enter into any settlement or compromise of any action or proceeding under Section 11.4(b) in a manner that diminishes the rights or interests of the other Party without the written consent of such other Party, which shall not be unreasonably withheld. Except as otherwise agreed by the Parties in connection with a cost-sharing arrangement, any recovery realized by SteadyMed as a result of any action or proceeding pursuant to Section 11.4(b) , whether by way of settlement or otherwise, shall be used first to reimburse each Party for the unreimbursed out-of-pocket litigation expenses incurred by such Party in such action or proceeding, provided that if such recovery is insufficient to fully reimburse both Parties for such litigation expenses, such recovery shall be allocated between the Parties on a pro rata basis in proportion to the relative share of such costs incurred by each Party. Any remaining recovery after such reimbursement shall be allocated as follows:

 

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(i)          in the case of any such action or proceeding brought by SteadyMed, any remaining recovery shall belong to SteadyMed; provided , however , that to the extent such recovery is attributable to Competitive Infringement:

 

(1)        that portion of such remaining recovery that represents compensatory damages for such Competitive Infringement shall be allocated [...***...] to SteadyMed and [...***...] to Cardiome; and

 

(2)        that portion of such remaining recovery that represents non-compensatory damages for such Competitive Infringement shall be allocated [...***...] to SteadyMed and [...***...] to Cardiome; and

 

(ii)          in the case of any such action or proceeding brought by Cardiome:

 

(1)        that portion of any remaining recovery that represents compensatory damages for Competitive Infringement shall be allocated [...***...] to Cardiome and [...***...] to SteadyMed; and

 

(2)        that portion of any remaining recovery that represents non-compensatory damages for Competitive Infringement shall be allocated [...***...] to Cardiome and [...***...] to SteadyMed.

 

11.5         Infringement of Third Party Patents . Each Party shall promptly notify the other in writing of any allegation by a Third Party that the activity of either Party pursuant to this Agreement infringes or may infringe the intellectual property rights of such Third Party. Without limiting the generality of the foregoing, in the event either Party receives any written communication from any Third Party alleging that the manufacture, use, sale, offer for sale or import of a Supplied Item in the Territory infringes or may infringe a Patent of a Third Party, such Party shall deliver a copy of such communication to the other Party within [...***...] of receipt. SteadyMed shall have the sole right and responsibility to respond to such communication and to determine the course of action, including whether or not to seek a license under such Third Party’s Patent or contest and defend against such allegation (subject to Section 13.2 hereof), in such manner as SteadyMed, in its sole judgment, deems appropriate, and at SteadyMed’s sole expense. In no event shall Cardiome or any of its Affiliates, directly or indirectly, make or cause to be made any admission or acknowledgment, whether orally, in writing or otherwise, that the manufacture, use, sale, offer for sale or import of any Supplied Item in the Territory infringes or may infringe, or otherwise is or may be within the scope of, such Third Party’s Patent. If SteadyMed or its Affiliate obtains a license under such Third Party’s Patent to make, have made, use, sell, have sold, offer for sale or import Product or Infusion Set in the Field in the Territory (whether in connection with the settlement of any infringement action or proceeding by such Third Party or otherwise), such Patent shall be included in the SteadyMed Patents licensed to Cardiome under Section 2.1 , and SteadyMed shall be solely responsible for the payment to such Third Party of all royalties and milestone payments that become due to such Third Party under the license agreement with such Third Party as a result of the Commercialization by or on behalf of Cardiome, its Affiliates, Sublicensees or Subdistributors of Product or Infusion Set in the Field in the Territory in accordance with this Agreement, provided that Cardiome shall provide to SteadyMed on a timely basis all such information regarding Cardiome’s and its Affiliates’, Sublicensees’ and Subdistributors’ activities as is necessary for SteadyMed to ascertain and comply with its royalty and milestone payment obligations to such Third Party. Neither Party shall have the right to settle any patent infringement litigation under this Section 11.5 in a manner that diminishes the rights or interests of the other Party without the written consent of such other Party (which consent shall not be unreasonably conditioned, withheld or delayed).

 

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(a)        SteadyMed will be responsible for, and compensate Cardiome for any actual damages obtained by a Third Party against Cardiome for infringement of said Third Party’s Patent as a result of the Commercialization by or on behalf of Cardiome, its Affiliates, Sublicensees or Distributors of Product or Infusion Set in the Field in the Territory in accordance with this Agreement. Notwithstanding the above, SteadyMed will not be responsible for infringing act(s) if such act(s) are principally due to Cardiome marketing and/or selling outside the Field and/or outside the Territory, outside of the claims of any Product label or insert, or any substantially similar act.

 

(b)        Notwithstanding the above if Cardiome does not agree to share some of the potential liability through discussions at the JSC, at SteadyMed’s written request, Cardiome, its Affiliates, Sublicensee or Distributor will discontinue sales of Product or Infusion Sets under this Agreement in a country in which said Third Party has sued Cardiome, its Affiliate, Sublicensee or Distributor for patent infringement.

 

11.6         Patent Term Extensions . SteadyMed shall have the final decision-making authority as to whether or not to apply for patent term extensions for SteadyMed Patents for Product in the Field in the Territory and, if so, as to the selection of the applicable SteadyMed Patent, and if SteadyMed elects to do so, it shall do so at its own expense. Cardiome shall cooperate fully with SteadyMed in making such filings or actions, for example and without limitation, by making available all required regulatory data and information and executing any required authorizations to apply for such patent term extension.

 

11.7         Trademarks .

 

(a)         Ownership . SteadyMed shall at all times own all right, title, and interest in and to the SteadyMed Trademarks, including all corresponding trademark applications and registrations thereof, and all common law rights thereto, throughout the world. All goodwill of the business associated with or symbolized by the SteadyMed Trademarks, including all goodwill arising out of Cardiome’s and its Affiliates’, Sublicensees’ and Permitted Subdistributors’ use of the SteadyMed Trademarks in the Territory, shall inure to the benefit of SteadyMed, and, to that end, Cardiome shall assign, and hereby does assign, to SteadyMed, and shall obtain from its Affiliates, Sublicensees and Permitted Subdistributors a present assignment and agreement to assign to SteadyMed, all rights any of them may have therein. Cardiome acknowledges SteadyMed’s exclusive ownership of the SteadyMed Trademarks, and all goodwill of the business associated with or symbolized by the SteadyMed Trademarks, and agrees not to take, and to require its Affiliates, Sublicensees and Permitted Subdistributors not to take, any action inconsistent with such ownership. SteadyMed acknowledges Cardiome’s exclusive ownership of the Cardiome House Marks and all goodwill of the business associated with or symbolized by the Cardiome House Marks and acknowledges and agrees that no right or license under Cardiome House Marks is granted to SteadyMed hereunder.

 

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(b)         Use of Trademarks . Except to the extent prohibited by Applicable Laws, all Promotional Materials and Product Labels and Inserts shall bear both the SteadyMed Trademarks and the Cardiome House Marks, and the Parties shall mutually agree as to the placement and relative prominence of the SteadyMed House Marks and the Cardiome House Marks on all Promotional Materials and Product Labels and Inserts, subject to Applicable Laws. Cardiome shall discuss and refer to Products and Infusion sets only under the Product Marks, and shall use the SteadyMed Trademarks only on the Promotional Materials and Product Labels and Inserts and only in accordance with the terms and conditions of this Agreement. In using any SteadyMed Trademark, Cardiome shall comply with all Trademark policies, instructions and guidelines provided by SteadyMed from time to time to maintain the goodwill and value of the SteadyMed Trademarks. Cardiome shall not, and shall require its Affiliates and Sublicensees not to, (i) use, seek to register, or otherwise claim rights in the Territory in any Trademark that is confusingly similar to, misleading or deceptive with respect to, or that materially dilutes, any SteadyMed Trademark, (ii) adopt, use, or attempt to register any Trademarks that are confusingly similar to the SteadyMed Trademarks or use any SteadyMed Trademark in such a way as to create combination marks with such SteadyMed Trademark (including, without limitation, any such combination mark with any Cardiome House Mark or other Cardiome Trademarks); or (iii) knowingly do, cause to be done, or knowingly omit to do any act, the doing, causing or omitting of which endangers, undermines, impairs, destroys or similarly affects, in any material respect, the validity or strength of any SteadyMed Trademark (including any registration or pending registration application relating thereto) or the value of the goodwill pertaining to any SteadyMed Trademark. All rights to use the SteadyMed Trademarks granted hereunder shall automatically terminate upon the expiration or termination of this Agreement.

 

(c)         Registration . SteadyMed shall have the sole right, but not the obligation, to apply for registration of, register and renew any registration of the SteadyMed Trademarks, at SteadyMed’s sole expense.

 

(d)         Infringement . Cardiome shall promptly inform SteadyMed of any infringement of, or challenge to, any SteadyMed Trademark in the Territory, in each case whether actual or threatened, which comes to the attention of Cardiome. SteadyMed shall have the exclusive right (in its sole discretion) to take (or not take, as applicable) action in respect of the defense or infringement of the SteadyMed Trademarks, at SteadyMed’s sole expense, and, at SteadyMed’s request and expense, Cardiome shall provide reasonable assistance and cooperation in connection therewith.

 

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Article 12

 

REPRESENTATIONS AND WARRANTIES; DISCLAIMER; LIMITATION OF LIABILITY

 

12.1         Mutual Representations and Warranties . Each Party represents and warrants to the other Party that, as of the Effective Date:

 

(a)         such Party is duly organized and validly existing under the laws of its jurisdiction of incorporation or formation, and has full corporate or other power and authority to enter into this Agreement and to carry out the provisions hereof;

 

(b)         it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder;

 

(c)         this Agreement is legally binding upon it, enforceable in accordance with its terms, and does not violate, conflict with, or constitute a default under, its charter or similar organization document, its by-laws or partnership agreement, or the terms or provisions of any material agreement or other instrument to which it is a party or by which it is bound, or any order, award, judgment or decree to which it is a party or by which it is bound;

 

(d)         neither such Party nor any of its Affiliates is debarred under Applicable Laws in the US, including 21 U.S.C. §335a, or any comparable Applicable Laws outside of the U.S.; and

 

(e)          Representations and Warranties . With respect to their performance under this Agreement, each Party hereby represents, warrants, covenants and certifies the following

 

(i)         None of each Party or their respective Representatives has caused nor shall cause the other Party or its Affiliates to be in violation of the Anti-Corruption Laws or the U.S. Travel Act.

 

(ii)          Additional Provisions :

 

(1)        Each Party and its Representatives shall not with a corrupt intent directly or indirectly offer, promise, authorize, pay, or give any money, favor, advantage, bribe, kickback, or anything else of value to an Official (as defined below) or to any other individual or entity for purposes of obtaining, retaining, or directing business or any other improper advantage;

 

(2)        Each Party understands that “ Official ” means (i) a director, officer, employee, agent or representative of any government, military, or state-owned or affiliated entity or organization; (ii) any department, agency, corporate entity, instrumentality or political subdivision of any government or military; (iii) any person or commercial entity acting in an official capacity for or on behalf of any government or military; (iv) any candidate for political office, any political party or any official of a political party; or (v) any officer, employee, agent or representative of any public international organization such as the United Nations or the World Bank; and

 

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(3)        Neither Cardiome nor, to Cardiome’s knowledge, any of its affiliates or representatives or its and their respective equity shareholders, officers, directors, employees, representatives, members, partners or managers or, to Cardiome’s knowledge, any immediate family member of the foregoing persons (collectively, “ Interested Persons ”) is an Official or a potential customer of SteadyMed in the Territory. Cardiome shall notify SteadyMed promptly if (i) an Interested Person becomes a Foreign Official or (ii) a Foreign Official becomes an Interested Person or acquires a personal interest in the income of Cardiome.

 

(4)        Nothing within this Section 12.1(e) should be construed or understood to expand the reach of the Anti-Corruption Laws or the U.S. Travel Act.

 

(f)        Both Parties agree to vet and approve any new third party broker, agent, sub representative or other contractor who interacts with Officials in the performance of services under this Agreement, and to periodically update the JSC with respect to the same.

 

(g)        Each Party shall respond to the other Party’s requests for information, to the extent reasonable and related to each Party’s efforts to ensure compliance with the Anti-Corruption Laws and any other applicable law.

 

(h)        Each Party shall cooperate and shall cause Representative Persons to maintain receipts, material documents, and books and records (collectively “ Records ”) that reflect completely and in reasonable detail its transactions and other expenses related to the performance of services under this Agreement. Each Party may in its sole discretion audit such books and records if other Party reasonably suspects that a material issue or a violation has or will occur with respect to the Anti-Corruption Laws, Export Control Laws, or any other law or regulation applicable to either or both Parties. Each Party shall provide the other Party and its Representatives reasonable access to Records for up to [...***...] after the expiration or termination of this Agreement. Each Party may also reasonably suspend all payments owed to the other Party pursuant to this Agreement until such time that the first Party has reasonably determined that such payment will not cause a material violation of the Anti-Corruption Laws, Export Control Laws, or any other applicable law or regulation.

 

(i)        Each Party shall immediately notify the other Party if the Party has any information or suspicion that there may be a violation of the Anti-Corruption Laws or any other applicable law in connection with this Agreement.

 

(j)        Each Party shall reasonably cooperate with the other Party in regard to any matter, dispute or controversy related to this Agreement and in which each Party may become involved and of which the other Party may have knowledge. Such obligation shall continue after the expiration or termination of this Agreement.

 

(k)        During the term of this Agreement, each Party shall, upon the other Party’s reasonable request, certify in writing from time to time its compliance with the representations and warranties contained in this Section 9.1 .

 

(l)        Each Party shall maintain and shall reasonably cause its Representatives to comply with policies and procedures which are (i) substantially consistent with the foregoing representations, warranties, covenants and certifications and (ii) in compliance with all anti-corruption laws and regulations applicable to each Party and their respective Representatives.

 

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(m)         Termination for Non-Compliance . A violation of the foregoing representations, warranties, covenants or certifications by either Party or their respective Representatives set forth in this Section 12.1 shall constitute a material breach of this Agreement. However, notwithstanding anything else in this Agreement to the contrary, once a senior officer of either Party receives notices of any violation of this Section 12.1 , such Party may cure the breach by

 

(i)        the Party will immediately cease the action that gives rise to the breach until the matter is resolved favorably;

 

(ii)        investigate the activities and nature of the breach, and determine immediate and/or near term corrective action(s); and

 

(iii)        assess the need for self-reporting, and if self-reporting is necessary, cooperate with the agency responsible for overseeing the breach during any investigation and with any subsequent fines or remediation imposed by said agency.

 

12.2         Mutual Covenants . In addition to any covenants made by either Party elsewhere in this Agreement, each Party hereby covenants to the other Party that:

 

(a)        neither such Party nor any of its Affiliates will employ or use the services of any Person who is debarred under Applicable Laws in the U.S., including 21 U.S.C. §335a, or any comparable Applicable Laws outside of the U.S., in connection with the matters that are the subject of this Agreement or the performance of its obligations hereunder; and in the event that such Party becomes aware of the debarment or threatened debarment of any Person providing services to such Party or any of its Affiliates in connection with the matters that are the subject of this Agreement or the performance of its obligations hereunder, such Party will immediately notify the other Party in writing and will cease, or cause its Affiliate to cease (as applicable), employing, contracting with, or retaining, any such Person to perform any activity contemplated by this Agreement; and

 

(b)        such Party will not enter into any agreement or other instrument that would conflict with its obligations under this Agreement.

 

12.3         Product Warranty . SteadyMed represents and warrants to Cardiome that all Supplied Items delivered by or on behalf of SteadyMed pursuant to this Agreement: (a) as of the Delivery Date, will conform to the applicable Specifications for such Supplied Items as then in effect; (b) will have been Manufactured in compliance with applicable Manufacturing Standards and SteadyMed’s obligations under the Quality Agreement; and (c) will not be adulterated or misbranded within the meaning of the FFDCA (collectively, the “ Product Warranty ”); provided , however , that SteadyMed makes no representation or warranty, and the Product Warranty specifically excludes any representation or warranty, with respect to: (i) the conformity of any Product Labels and Inserts provided by Cardiome to SteadyMed or the applicable Contract Manufacturer for use in the Manufacture of a Supplied Item for a particular country of the Territory, to the Approved Labeling for such Supplied Item in such country; (ii) the compliance of any Product Labels and Inserts provided by Cardiome to SteadyMed or the applicable Contract Manufacturer for use in the Manufacture of a Supplied Item for a particular country of the Territory, with Applicable Laws in such country; or (iii) the accuracy of the translation of any Product Labels and Inserts provided by Cardiome to SteadyMed or the applicable Contract Manufacturer for use in the Manufacture of a Supplied Item for a particular country of the Territory, into any language.

 

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12.4         Representations, Warranties and Covenants by SteadyMed . SteadyMed hereby represents and warrants to Cardiome that, as of the Effective Date:

 

(a)        the Patents listed in Schedule 1.107 hereto constitute all of the SteadyMed Patents existing as of the Effective Date;

 

(b)        to SteadyMed’s knowledge, the issued patents listed in Schedule 1.107 hereto are valid and enforceable;

 

(c)        the patent applications listed in Schedule 1.107 have been duly filed;

 

(d)        SteadyMed is the sole owner of all right, title and interest in and to the SteadyMed Patents existing on the Effective Date, free of any encumbrances;

 

(e)        SteadyMed (i) has the right to grant the license under SteadyMed Technology that it purports to grant pursuant to Section 2.1 , and (ii) has not granted to any Third Party any license or other right with respect to any SteadyMed Technology that conflicts with the license granted pursuant to Section 2.1 ;

 

(f)        to SteadyMed’s knowledge, the manufacture, use, sale, offer for sale and import of Product and Infusion set in the Field in the Territory do not infringe any issued patent of any Third Party;

 

(g)        SteadyMed is not a party to any legal action, suit or other legal proceeding relating to the SteadyMed Technology, and SteadyMed has not received any written communication from any Third Party threatening such action, suit or proceeding; and

 

(h)        As of the Launch Date, SteadyMed will have the manufacturing infrastructure in place in order to be able to produce Supplied Items.

 

Representations and Warranties by Cardiome . Cardiome hereby represents and warrants to SteadyMed that, as of the Effective Date:

 

(a)        Cardiome has the commercial expertise to market the Product in the Territory and will use Commercially Reasonable Efforts to sell Supplied Items on a FIFO (First-In, First-Out basis);

 

(b)        there is no pending, nor, to the knowledge of Cardiome any threatened investigation or audit by the FDA, EMA, or other governmental entity and/or Agency which is a counterpart of the FDA or EMA into Cardiome that would impact Cardiome’s ability to commercialize the Product in the Territory; and

 

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(c)        Cardiome is not currently suspended or excluded from participating, or otherwise ineligible to participate, in any national health insurance program or system or other governmental reimbursement program in any country of the Territory, or in any governmental procurement or non-procurement programs in the Territory, or otherwise excluded from contracting with the government of any country in the Territory.

 

12.5         Disclaimer of Warranties . Except as expressly set forth in this Agreement, THE TECHNOLOGY AND INTELLECTUAL PROPERTY RIGHTS PROVIDED BY EACH PARTY HEREUNDER ARE PROVIDED “AS IS.” Except as expressly set forth in this Agreement, EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF PATENTS, NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES.

 

12.6         Limitation on Liability . EXCEPT FOR LIABILITY FOR BREACH OF Article 10 , NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER; provided , however , that this Section 12.6 shall not be construed to limit either Party’s indemnification obligations under Article 13 .

 

Article 13

 

INDEMNIFICATION; INSURANCE

 

13.1         Indemnification by Cardiome . Subject to the procedures set forth in Section 13.3 , Cardiome shall indemnify SteadyMed, its Affiliates and its and their respective directors, officers, employees, consultants and agents (the “ SteadyMed Indemnitees ”), and defend and save each of them harmless, from and against any and all losses, damages, liabilities, expenses and costs, including reasonable legal expense and attorneys’ fees (collectively, “ Losses ”), to which any SteadyMed Indemnitee may become subject as a result of any claim, demand, action or other proceeding by any Third Party (each, a “ Third Party Claim ”), to the extent such Losses arise out of or relate to (a) any theory of product liability (including without limitation tort, warranty, or strict liability) that is applicable in the Territory with respect to the death, personal injury, or illness of any person in the Territory, arising from the use, Commercialization, storage, release or handling by or on behalf of Cardiome or any of its Affiliates, Sublicensees or Permitted Subdistributors of any Supplied Item in the Territory; (b) the gross negligence or willful misconduct of any Cardiome Indemnitee (defined below); or (c) the breach by Cardiome of any warranty, representation, covenant or agreement made by Cardiome in this Agreement; except, in each case, to the extent such Losses result from the gross negligence or willful misconduct of any SteadyMed Indemnitee or the breach by SteadyMed of any warranty, representation, covenant or agreement made by SteadyMed in this Agreement.

 

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13.2         Indemnification by SteadyMed . Subject to the procedures set forth in Section 13.3 , SteadyMed shall indemnify Cardiome, its Affiliates and its and their respective directors, officers, employees, consultants and agents (the “ Cardiome Indemnitees ”), and defend and save each of them harmless, from and against any and all Losses to which any SteadyMed Indemnitee may become subject as a result of any Third Party Claim, to the extent such Losses arise out of or relate to (a) any theory of product liability (including without limitation tort, warranty, or strict liability) that is applicable in the Territory with respect to the death, personal injury, or illness of any person in the Territory, arising from the Manufacture, storage, release or handling by or on behalf of SteadyMed or any of its Affiliates or Contract Manufacturers of any Supplied Item; (b) the gross negligence or willful misconduct of any SteadyMed Indemnitee; (c) the breach by SteadyMed of any warranty, representation, covenant or agreement made by SteadyMed in this Agreement; or (d) any Third Party Claim that the manufacture, use, sale, offer for sale or import of any Supplied Item in the Field in the Territory in accordance with this Agreement infringes any Third Party’s Patent in the Territory; except, in each case, to the extent such Losses result from the gross negligence or willful misconduct of any Cardiome Indemnitee or the breach by Cardiome of any warranty, representation, covenant or agreement made by Cardiome in this Agreement.

 

13.3         Indemnification Procedure . In the event a Party (the “ Indemnified Party ”) seeks indemnification under Section 13.1 or Section 13.2 , it shall inform the other Party (the “ Indemnifying Party ”) of a Third Party Claim as soon as reasonably practicable after it receives notice of the Third Party Claim (it being understood and agreed, however, that the failure by an Indemnified Party to give notice of a claim as provided in this Section 13.3 shall not relieve the Indemnifying Party of its indemnification obligation under this Agreement unless and only to the extent that such Indemnifying Party is actually damaged as a result of such failure to give notice), shall permit the Indemnifying Party to assume direction and control of the defense of the Third Party Claim (including the right to settle the Third Party Claim solely for monetary consideration) using counsel reasonably satisfactory to the Indemnified Party, and shall cooperate as requested (at the expense of the Indemnifying Party) in the defense of the Third Party Claim. If the Indemnifying Party does not assume control of such defense within [...***...] after receiving notice of the Third Party Claim from the Indemnified Party, the Indemnified Party shall control such defense and, without limiting the Indemnifying Party’s indemnification obligations, the Indemnifying Party shall reimburse the Indemnified Party for all costs, including reasonable attorney fees, incurred by the Indemnified Party in defending itself within [...***...] after receipt of any invoice therefor from the Indemnified Party. The Party not controlling such defense may participate therein at its own expense. The Party controlling such defense shall keep the other Party advised of the status of such action, suit, proceeding or claim and the defense thereof and shall consider recommendations made by the other Party with respect thereto. The Indemnified Party shall not agree to any settlement of such action, suit, proceeding or claim without the prior written consent of the Indemnifying Party, which shall not be unreasonably withheld, delayed or conditioned. The Indemnifying Party shall not agree to any settlement of such action, suit, proceeding or claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto, that imposes any liability or obligation on the Indemnified Party or that acknowledges fault by the Indemnified Party without the prior written consent of the Indemnified Party.

 

13.4         Insurance . Each Party shall at all times maintain insurance policies or self-insurance in such amounts and with such scope of coverage as are normal and customary for companies in the pharmaceutical or biotechnology industry of a size and stage of development similar to that of such Party and engaged in activities comparable to the activities in which such Party engages hereunder. If requested by the other Party, the insured Party shall furnish a Certificate of Insurance or other reasonable proof of coverage (which may be a certificate or other evidence issued by a Party under a program of self-insurance) evidencing the requisite coverage required under this Section 13.4 during the Term.

 

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Article 14

 

TERM AND TERMINATION

 

14.1         Term . The term of this Agreement (the “ Term ”) shall begin on the Effective Date and, subject to earlier termination of this Agreement as expressly permitted herein, shall expire on the tenth (10th) anniversary after the Launch Date.

 

14.2         Termination . In addition to any termination right expressly granted to a Party elsewhere in this Agreement, this Agreement may be terminated by a Party prior to its expiration as follows:

 

(a)           Major Safety Issue . Either Party may terminate this Agreement upon written notice to the other Party with immediate effect in the event that: (i) the Parties determine that the continued Commercialization of the Product in the Territory poses an unacceptable medical risk to patients; or (ii) the EMA or any other Regulatory Authority in the Territory requires Cardiome to cease Commercializing the Product in the Territory.

 

(b)           Debarment . By either Party if the other Party is debarred or disqualified by any Regulatory Authority in the Territory, or, is determined by a court or other Governmental Agency in the Territory (whether or not such determination is appealable).

 

(c)           Termination for Insolvency . Either Party may terminate this Agreement upon written notice to the other Party with immediate effect in the event that 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 reorganization or for an arrangement or for the appointment of a receiver or trustee of the other 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 within [...***...] after the filing thereof, or if the other Party shall propose or be a Party to any dissolution or liquidation.

 

(d)           Termination for Material Breach .

 

(i)        This Agreement may be terminated by a Party upon written notice to the other Party if the other Party is in material breach of this Agreement and has not cured such breach within [...***...] ([…***…] with respect to any payment breach under Section 7.1 , [...***...] with respect to any payment breach under Sections 7.2 and 7.3 , along with interest as provided for in Section 8.7 ) after written notice from the terminating Party requesting cure of the breach. Any such termination shall become effective at the end of such [...***...] ([…***…] with respect to any payment breach under Section 7.1 , [...***...] with respect to any payment breach under Sections 7.2 and 7.3 , along with any interest as provided for in Section 8.7 ) period unless the breaching Party has cured any such breach or default prior to the end of such period; provided , however , that any right to terminate this Agreement under this Section shall be stayed and the cure period tolled in the event that, during any cure period, the Party alleged to have been in material breach shall have initiated dispute resolution in accordance with Section 15.1(b) with respect to the alleged breach, which stay and tolling shall continue until such dispute has been resolved in accordance with Section 15.1(b) .

 

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(ii)        Notwithstanding Section 14.2(b) (i), solely in the event of Cardiome’s material breach of its obligations under Section 6.3 or Section 6.4 in either Europe or Canada (but not both of such Regions), SteadyMed shall have the right to terminate all rights and licenses granted to Cardiome under this Agreement with respect solely to such Region, upon [...***...] written notice to Cardiome, if Cardiome has not cured such material breach by the end of such [...***...] period, in which event, from and after the effectiveness of such notice of termination, the Territory shall be deemed to exclude such Region for all purposes under this Agreement, but this Agreement shall otherwise remain in full force and effect in accordance with its terms; provided , however , that any right to terminate under this Section 14.2(b) (ii) shall be stayed and the cure period tolled in the event that, during any cure period, Cardiome shall have initiated dispute resolution in accordance with Section 15.1(b) with respect to the alleged breach, which stay and tolling shall continue until such dispute has been resolved in accordance with Section 15.1(b) .

 

(e)         At-Will Termination by Cardiome .

 

(i)         Termination of Agreement . Cardiome shall have the right to terminate this Agreement for any reason or for no reason at any time upon [...***...] prior written notice to SteadyMed.

 

(ii)         Termination as to a Region . Cardiome shall have the right to terminate all rights and licenses granted to Cardiome under this Agreement with respect solely to a particular Region, or to a country with a particular Region, for any reason or for no reason at any time, upon [...***...] prior written notice to SteadyMed, in which event, from and after the effectiveness of such notice of termination, the Territory shall be deemed to exclude such Region for all purposes under this Agreement, but this Agreement shall otherwise remain in full force and effect in accordance with its terms.

 

14.3         Effect of Expiration or Termination .

 

(a)        Upon the effective date of expiration or termination of this Agreement, the licenses granted by SteadyMed to Cardiome hereunder shall terminate and revert to SteadyMed, and all other rights and obligations of the Parties under this Agreement shall terminate and be of no force or effect, except as expressly set forth below in this Section 14.3 or in Section 14.4 .

 

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(b)        In the event of any termination of this Agreement by SteadyMed pursuant to Section 14.2(a) to (d) , or by Cardiome pursuant to Section 14.2(a) to (e) , the following shall apply (in addition to the provisions of Section 14.3(a) and 14.4 ):

 

(i)         Regulatory and Pricing Approvals . Cardiome shall, at Steadymed’s cost and written request, promptly: (A) transfer or assign, or cause to be transferred or assigned, to SteadyMed or its designee (or to the extent transfer or assignment is not permitted by Applicable Law, take all reasonable actions to make available to SteadyMed or its designee the full benefits of) all Regulatory Applications, Regulatory Approvals, regulatory dossiers, applications for Pricing Approval, and Pricing Approvals, for Product in the Territory, whether held in the name of Cardiome, its Affiliate or a Sublicensee or Subdistributor; (B) provide to SteadyMed or its designee a complete copy of all of the foregoing documents, as well as copies of all correspondence with Regulatory Authorities or Pricing Authorities pertaining to Products in the Territory; and (C) take such other actions and execute such other instruments, assignments and documents as may be necessary to effect, evidence, register and record the transfer, assignment or other conveyance of rights under this Section 14.3(b)(i) to SteadyMed or its designee. Notwithstanding the above, if Cardiome cannot complete (A) through (C) as set forth above due to Applicable Law or contracts that prohibit the same, Cardiome will take all reasonable actions to make the above available to SteadyMed or SteadyMed’s designee at SteadyMed’s cost.

 

(ii)         Transition . Cardiome shall, at SteadyMed’s cost and written request, cooperate with SteadyMed or its designee to effect a smooth and orderly transition of Commercialization activities with respect to Product and Infusion Set in the Territory.

 

(iii)         Inventory . SteadyMed shall have the right, but not the obligation, to purchase from Cardiome any or all of the usable inventory of any Supplied Item, including Non-Commercial Units, in Cardiome’s or its Affiliates’ possession as of the date of termination, at a purchase price equal to the Transfer Price paid by Cardiome for such inventory. Any packaging, transport, insurance and other costs relating to delivery shall be borne by SteadyMed. In addition, if SteadyMed does not purchase the inventory, Cardiome may sell off any inventory of Supplied Items in its or its possession as of the termination date during the [...***...] period beginning on the termination date, at a price no less than existed prior to the termination date, or if applicable, complete performance of any and all bid and tender agreements that had been entered into prior to the termination date.

 

(iv)         Promotional Materials . Cardiome shall, if requested by SteadyMed, deliver to SteadyMed all Promotional Materials in Cardiome’s or its Affiliates’ possession (including electronic files of all Promotional Materials) at Cardiome’s out-of-pocket cost for printing and delivering such materials.

 

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(v)         Commercial Agreements . Cardiome shall promptly provide to SteadyMed a list of all agreements in effect between Cardiome or any of its Affiliates and any Third Party wholesalers, hospitals, large EU/Middle East/Canadian - centric points of sale, retail pharmacies, mail-order pharmacies, group purchasing organizations and other similar organizations, relating to Product in the Territory (“ Cardiome Commercial Agreements ”), including the identity of and contact information for each such Third Party, the type of agreement, and whether such Cardiome Commercial Agreement relates solely to Product, Infusion Set and/or Supplied Items, or also covers other products of Cardiome and its Affiliates. Upon SteadyMed’s request, Cardiome shall provide SteadyMed with a true and complete copy of any such Cardiome Commercial Agreement that relates solely to Product, Infusion Set and/or Supplied Items. At the written request of SteadyMed, Cardiome shall assign, or cause its Affiliate to assign, to SteadyMed or its designee any Cardiome Commercial Agreement that relates solely to Product, Infusion Set and/or Supplied Items, to the extent such Cardiome Commercial Agreement permits such assignment. Cardiome shall use Commercially Reasonable Efforts to include provisions requiring compliance with the foregoing provision in Cardiome Commercial Agreements.

 

(c)        In the event of any termination of all rights and licenses granted to Cardiome under this Agreement with respect solely to a particular Region, either by SteadyMed pursuant to Section 14.2(b) (ii) or by Cardiome pursuant to Section 14.2(d) (ii), the provisions of Section 14.3(b) shall apply, mutatis mutandis , solely with respect to such Region.

 

(d)        In the event of any termination of this Agreement by Cardiome pursuant to Section 14.2(b) , Cardiome and its Affiliates shall have the right, at Cardiome’s option, to sell off any inventory of Supplied Items in its or their possession as of the termination date during the [...***...] period beginning on the termination date, or if applicable, complete performance of any and all bid and tender agreements that had been entered into prior to the termination date, subject to the terms and conditions of this Agreement, including, without limitation, payment of royalties in accordance with Section 7.4 .

 

14.4         Return of Confidential Information . Upon termination or expiration of this Agreement, each Party shall promptly return to the other Party, or delete or destroy, all relevant records and materials in such Party’s possession or control containing Confidential Information of the other Party; provided , however , that: (a) SteadyMed shall not be obligated to return, delete or destroy any such materials that contain Confidential Information of Cardiome that is necessary or useful for the use, sale, offer for sale, import or Commercialization of Product and Infusion Set in the Territory; and (b) each Party may retain one copy of such materials in its secure archives solely (i) for the purpose of monitoring compliance with its obligations under Article 10 or (ii) as necessary to comply with Applicable Laws, subject to Article 10 .

 

14.5         Accrued Rights; Survival .

 

(a)        Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration (including any amounts payable by either Party in accordance with the terms hereof with respect to periods prior to such termination or expiration), nor will expiration or termination of this Agreement preclude either Party from pursuing all rights and remedies it may have under this Agreement, at law or in equity, with respect to any breach of this Agreement.

 

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(b)         Articles 10 , 12 and 15 of this Agreement shall survive expiration or termination of this Agreement for any reason.

 

Article 15

 

MISCELLANEOUS

 

15.1         Governing Law; Dispute Resolution; Arbitration .

 

(a)          Governing Law . This Agreement shall be governed and construed in accordance with the laws of the New York State (USA), without giving effect to any choice of law provisions thereof with the exception of sections 5 -1401 and 5-1402 of New York General Obligations Law.

 

(b)          Dispute Resolution; Arbitration .

 

(i)         Dispute Resolution . Subject to Section 15.1(c) , any claim, dispute, or controversy as to the breach, enforcement, interpretation or validity of this Agreement (each, a “ Dispute ”) will be referred to the Executives for attempted resolution. In the event such Executives are unable to resolve such Dispute within [...***...] of such Dispute being referred to them, then, upon the written request of either Party to the other Party, the Dispute shall be subject to arbitration in accordance with Section 15.1(b)(ii) , except as expressly set forth in Section 15.1(c) .

 

(ii)         Arbitration .

 

(1)         Claims . Subject to Section 15.1(c) below, any Dispute that is not resolved under Section 15.1(b)(i) within the applicable [...***...] period shall be resolved by final and binding arbitration administered by the International Centre for Dispute Resolution in accordance with its then-effective International Dispute Resolution Procedures (the “ Rules ”), except to the extent any such Rule conflicts with the express provisions of this Section 15.1(b)(ii) . (Capitalized terms used but not otherwise defined in this Agreement shall have the meanings provided in the Rules.) The Arbitration shall be conducted by one neutral arbitrator selected in accordance with the Rules, provided that such individual shall not be a current or former employee or director, or a current stockholder, of either Party or any of their respective Affiliates (or any licensee or sublicensee of the rights granted to such Party under this Agreement) and shall have at least 15 years of pharmaceutical industry experience. The arbitration and all associated discovery proceedings and communications shall be conducted in English, and the arbitration shall be held in San Francisco, California, USA.

 

(2)         Discovery . Within [...***...] after selection of the Arbitrator, the Arbitrator shall conduct the Preliminary Conference. In addressing any of the subjects within the scope of the Preliminary Conference, the Arbitrator shall take into account both the desirability of making discovery efficient and cost-effective and the needs of the Parties for an understanding of any legitimate issue raised in the Arbitration. In addition, each Party shall have the right to take up to 40 hours of deposition testimony, including expert deposition testimony.

 

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(3)         Hearing; Decision . The Hearing shall commence within [...***...] after the selection of the Arbitrator. The Arbitrator shall require that each Party submit concise written statements of position and shall permit the submission of rebuttal statements, subject to reasonable limitations on the length of such statements to be established by the Arbitrator. The Hearing shall be no longer than [...***...] in duration. The Arbitrator shall also permit the submission of expert reports. The Arbitrator shall render the Award within [...***...] after the Arbitrator declares the Hearing closed, and the Award shall include a written statement describing the essential findings and conclusions on which the Award is based, including the calculation of any damages awarded. The Arbitrator will, in rendering his or her decision, apply the substantive law of the State of New York, USA, excluding its conflicts of laws principles with the exception of sections 5 -1401 and 5-1402 of New York General Obligations Law. The Arbitrator’s authority to award special, incidental, consequential or punitive damages shall be subject to the limitation set forth in Section 12.6 . The Award rendered by the Arbitrator shall be final, binding and non-appealable, and judgment may be entered upon it in any court of competent jurisdiction.

 

(4)         Costs . Each Party shall bear its own attorney’s fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the arbitrator; provided , however , that the Arbitrator shall be authorized, but not required, to determine whether a Party is the prevailing party, and if so, to award to that prevailing party reimbursement for any or all of its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), and/or the fees and costs of the Administrator and the Arbitrator.

 

(c)         Court Actions . Nothing contained in this Agreement shall deny either Party the right to seek injunctive or other equitable relief from a court of competent jurisdiction in the context of a bona fide emergency or prospective irreparable harm, and such an action may be filed and maintained notwithstanding any ongoing discussions between the Parties or any ongoing arbitration proceeding. In addition, either Party may bring an action in any court of competent jurisdiction to resolve disputes pertaining to the validity, construction, scope, enforceability, infringement or other violations of Patents, Trademarks, Copyrights or other intellectual property rights, and no such claim shall be subject to arbitration pursuant to Section 15.1(b)(ii) .

 

15.2         Force Majeure . Except with respect to either Party’s payment obligations under this Agreement, no liability shall result from delay in performance or non-performance, 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, civil commotion, terrorist act, malicious damage, epidemic, quarantine, fire, flood, storm, natural disaster or compliance with any law or government order, rule, regulation or direction, whether or not it is later held to be invalid. The non-performing Party shall promptly after the occurrence of the Force Majeure event give written notice to the other Party stating the nature of the Force Majeure event, its anticipated duration and any action being taken to avoid or minimize its effect. Any suspension of performance shall be of no greater scope and of no longer duration than is reasonably required and the non-performing Party shall use Commercially Reasonable Efforts to remedy its inability to perform; provided , however , if the suspension of performance continues for [...***...] after the date of the occurrence, and such failure to perform would constitute a material breach of this Agreement in the absence of such event of Force Majeure, the Parties shall meet and discuss in good faith any amendments to this Agreement to permit the other Party to exercise its rights under the Agreement.

 

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CONFIDENTIAL

 

15.3         Waiver and Non-Exclusion of Remedies . A Party’s failure to enforce, at any time or for any period of time, any provision of this Agreement, or to exercise any right or remedy, does not constitute a waiver of such provision, right or remedy, or prevent such Party thereafter from enforcing any or all provisions of this Agreement and exercising any or all other rights and remedies. To be effective any waiver must be in writing. Except as expressly set forth herein, the rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law.

 

15.4         Notices . Unless otherwise expressly provided for herein, any notice required or permitted to be provided by either Party to the other Party under this Agreement shall be in writing. Notices shall refer specifically to this Agreement and shall be sent by registered mail, by internationally recognized overnight delivery service, costs prepaid, or by facsimile or electronic mail, to the respective addresses specified below (or to such other address as may be specified by notice to the other Party):

 

If to Cardiome: General Counsel
Cardiome International Sárl
Rue des Alpes 21
Case Postale 1674
1201 Geneva Switzerland
Facsimile No.: [...***...]
E-mail address:
   
With a copy to: General Counsel
Cardiome Pharma Corp.
1441 Creekside Drive, 6th Floor
Vancouver, BC V6J 4S7
Canada
Facsimile No.: [...***...]
E-mail address: [...***...]
   
If to SteadyMed: SteadyMed Ltd.
c/o Therapeutics Inc.
2603 Camino Ramon
Suite 250
San Ramon, CA
94583
E-mail: [...***...]

 

  59  

CONFIDENTIAL

 

Any notice delivered electronically or by facsimile shall be confirmed by a hard copy delivered as soon as practicable thereafter. The effective date of any notice shall be the date of the addressee’s receipt, if received by 5:00 p.m. local time on a business day or, if not, the first business day after receipt.

 

15.5         Entire Agreement . This Agreement (including the Schedules attached hereto, which are incorporated herein by this reference) constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior or contemporaneous understandings or agreements, whether written or oral, with respect to the subject matter hereof, including the Confidentiality Agreement. Each Party confirms that it is not relying on any representations, warranties or covenants of the other Party except as specifically set forth herein. No amendment, modification, release or discharge of this Agreement shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties.

 

15.6         Assignment . Except as expressly provided hereunder, neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred by either Party without the prior written consent of the other Party (which consent shall not be unreasonably withheld); provided , however , that either Party may assign this Agreement and all of its rights and obligations hereunder without the other Party’s consent:

 

(a)        in connection with the transfer or sale of all or substantially all of the business of such Party to which this Agreement relates to a Third Party (“ Third Party Acquirer ”), whether by merger, sale of stock, sale of assets or otherwise (each, a “ Sale Transaction ”), provided that in the event of a Sale Transaction (whether this Agreement is actually assigned or is assumed by the Third Party Acquirer or the surviving corporation resulting from such Sale Transaction by operation of law (e.g., in the context of a reverse triangular merger)), intellectual property rights of the Third Party Acquirer that existed prior to the Sale Transaction shall not be included in the technology licensed hereunder or otherwise subject to this Agreement; or

 

(b)        to an Affiliate, provided that the assigning Party shall remain liable and responsible to the non-assigning Party hereto for the performance and observance of all such duties and obligations by such Affiliate.

 

The rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties, and the name of a Party appearing herein will be deemed to include the name of such Party’s successors and permitted assigns to the extent necessary to carry out the intent of this section. Any assignment not in accordance with this Section shall be void.

 

15.7         Counterparts . This Agreement may be executed by original, facsimile, or electronic signature (e.g., in a PDF format) and in several counterparts, all of which shall be deemed to be originals, and all of which shall constitute one and the same Agreement.

 

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CONFIDENTIAL

 

15.8         Severability; Blue Pencil . To the fullest extent permitted by Applicable Law, the Parties waive any provision of law that would render any provision in this Agreement invalid, illegal or unenforceable in any respect. If any provision of this Agreement is held to be invalid, illegal or unenforceable, in any respect, then such provision will be given no effect by the Parties and shall not form part of this Agreement. To the fullest extent permitted by Applicable Law and if the rights or obligations of either Party will not be materially and adversely affected, all other provisions of this Agreement shall remain in full force and effect and the Parties will use their best efforts to negotiate a provision in replacement of the provision held invalid, illegal or unenforceable that is consistent with Applicable Law and achieves, as nearly as possible, the original intention of the Parties.

 

15.9         Expenses . Each of the Parties shall pay the fees and expenses of its counsel and other experts and all other expenses incident to its negotiation, preparation, execution, and delivery of this Agreement.

 

15.10       Further Assurances . Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement.

 

15.11       Headings . The section headings of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement.

 

15.12       English Language . All information, documents, materials, data, notices and other written communications provided by one Party to the other Party shall be in the English language.

 

15.13      No Joint Venture . Nothing contained in this Agreement shall be construed as creating a partnership, joint venture or agency relationship between the Parties or, except as otherwise expressly provided herein, as granting to either Party the authority to bind or contract any obligation in the name of or on the account of the other Party, or to make any statements, representations, guarantees or warranties on behalf of the other Party. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party. The Parties agree that the rights and obligations under this Agreement are not intended to constitute a partnership or similar arrangement that will require separate reporting for tax purposes consistent with the intent reflected in the foregoing sentence and agree that they shall not file any reports, documents or other item relating to taxes or state or acknowledge to any tax authority that such relationship is a partnership or similar arrangement unless required by Applicable Law.

 

15.14       No Third Party Beneficiaries . The provisions of this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and they shall not be construed as conferring any rights in any other Persons.

 

[ The remainder of this page was left intentionally blank ]

 

  61  

CONFIDENTIAL

 

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

 

  SteadyMed Ltd.
     
    /s/ Jonathan M.N. Rigby
  Signature
    Name: Jonathan M.N. Rigby
    Title: President and CEO
       
  Cardiome Pharma Corp.
       
    /s/ William Hunter
  Signature
    Name: William Hunter
    Title: President and CEO
       
    /s/Jennifer Archibald
  Signature
    Name: Jennifer Archibald
    Title: CFO
       
  Correvio International Sárl
       
    /s/ David D. McMasters
  Signature
    Name: David D. McMasters
    Title: Director
       
    /s/ Jennifer Archibald
  Signature
    Name: Jennifer Archibald
    Title: Director

  

  62  

 

Exhibit 4.6

 

Execution Version

 

CIPHER PHARMACEUTICALS INC.

 

and

 

CARDIOME PHARMA CORP.

 

and

 

CORREVIO PHARMA CORP.

 

ARRANGEMENT AGREEMENT

 

March 19, 2018

 

 

 

  

TABLE OF CONTENTS

 

Article 1 INTERPRETATION 1
1.1 Definitions 1
1.2 Interpretation 12
1.3 Number, Gender and Persons 13
1.4 Date for Any Action 13
1.5 Currency 13
1.6 Accounting Matters 13
1.7 Knowledge 13
1.8 Schedules 13
     
Article 2 THE ARRANGEMENT 14
2.1 Arrangement 14
2.2 Obligations 14
2.3 Interim Order 14
2.4 Cardiome Meeting 15
2.5 Cardiome Circular 16
2.6 Final Order 17
2.7 Court Proceedings 18
2.8 Articles of Arrangement and Effective Date 18
2.9 Payment of Consideration 18
2.10 Announcements and Consultations 19
2.11 Withholding Taxes 19
2.12 List of Shareholders 19
2.13 U.S. Securities Law Matters 19
2.14 United States Tax Matters 20
2.15 Canadian Income Tax Matters 20
2.16 Incentive Plan Matters 21
2.17 Reorganization 22
     
Article 3 REPRESENTATIONS AND WARRANTIES OF CARDIOME AND CORREVIO 23
3.1 Representations and Warranties of Cardiome 23
3.2 Survival of Representations and Warranties of Cardiome 23
3.3 Representations and Warranties of Correvio 23
3.4 Survival of Representations and Warranties of Correvio 23
     
Article 4 REPRESENTATIONS AND WARRANTIES OF CIPHER 24
4.1 Representations and Warranties of Cipher 24
4.2 Survival of Representations and Warranties of Cipher 24
     
Article 5 COVENANTS 24
5.1 Covenants of Cardiome Relating to the Arrangement 24
5.2 Covenants of Cardiome Relating to the Conduct of Business 25
5.3 Transferred Employees 28
5.4 Post-Closing Filings 28
     
Article 6 CONDITIONS 28
6.1 Mutual Conditions Precedent 28
6.2 Additional Conditions Precedent in Favour of Cipher 30
6.3 Additional Conditions Precedent in Favour of Cardiome 31
6.4 Notice and Cure Provisions 31
6.5 Satisfaction of Conditions 32
     
Article 7 ADDITIONAL COVENANTS 32
7.1 Covenant Regarding Non-Solicitation 32

 

 

 

 

7.2 Covenant Regarding Acquisition Proposal 32
7.3 Right to Accept a Superior Proposal 34
7.4 Access to Information; Confidentiality; Transition 35
7.5 Insurance and Indemnification 36
7.6 ROFR on New Canadian Products 36
7.7 Product Introduction Fee 36
     
Article 8 TERM, TERMINATION, AMENDMENT AND WAIVER 37
8.1 Term 37
8.2 Termination 37
8.3 Expenses 38
8.4 Termination Payments 38
8.5 Termination Payment to Cardiome 39
8.6 Amendment 39
8.7 Waiver 40
     
Article 9 INDEMNITY AND WARRANTY 40
9.1 Correvio Indemnity 40
9.2 Cipher Indemnity 41
9.3 Taxable Gain Warranty 41
9.4 Claim Notice 42
9.5 Agency for Non-Parties 42
9.6 Procedure for Indemnification – Direct Claims 42
9.7 Procedure for Indemnification – Third Party Claims 42
9.8 Cooperation 43
9.9 Holdback Amount 44
9.10 Exclusive Remedy 44
9.11 No Double Recovery 44
9.12 Price Purchase Consideration Adjustment 45
     
Article 10 GENERAL PROVISIONS AND MISCELLANEOUS 45
10.1 Privacy 45
10.2 Notices 45
10.3 Governing Law 46
10.4 Injunctive Relief 46
10.5 Time of Essence 46
10.6 Entire Agreement, Binding Effect and Assignment 47
10.7 No Liability 47
10.8 Severability 47
10.9 Counterparts, Execution 47

 

SCHEDULES

 

SCHEDULE A

SCHEDULE B

SCHEDULE C

SCHEDULE D

SCHEDULE E

SCHEDULE F

SCHEDULE G

SCHEDULE H

SCHEDULE I

SCHEDULE J

 

  - 2 -  

 

  

ARRANGEMENT AGREEMENT

 

Arrangement Agreement dated March 19, 2018 among Cipher Pharmaceuticals Inc. (“ Cipher ”), Cardiome Pharma Corp. (“ Cardiome ”) and Correvio Pharma Corp. (“ Correvio ”).

 

WHEREAS:

 

A.        Cipher, Cardiome and Correvio wish to complete a transaction whereby, among other things: (i) all of the outstanding Cardiome Shares (as hereinafter defined) will be assigned and transferred to Correvio in exchange for Correvio Shares (as hereinafter defined); (ii) all of the assets and liabilities of Cardiome, other than the Retained Assets and Retained Liabilities (each as hereinafter defined), will be transferred to and assumed by Correvio; and (iii) Cipher will subsequently acquire all of the outstanding Cardiome Shares from Correvio;

 

B.        The Parties intend to carry out the transactions contemplated herein by way of a statutory plan of arrangement, which is to be completed under the provisions of the CBCA (as hereinafter defined), and on and subject to the terms and conditions contained herein;

 

C.        Cipher has entered into the Cardiome Voting Agreements (as hereinafter defined) with the Cardiome Supporting Shareholders (as hereinafter defined), pursuant to which, among other things, such Cardiome Supporting Shareholders agree, subject to the terms and conditions thereof, to vote the Cardiome Shares and any securities convertible, exercisable or exchangeable into Cardiome Shares held by them in favour of the Cardiome Arrangement Resolution (as hereinafter defined); and

 

D.        The Parties have entered into this Agreement to provide for the matters referred to in the foregoing recitals and for other matters relating to such arrangement.

 

NOW THEREFORE in consideration of the covenants and agreements herein contained and other good and valuable consideration (the receipt and sufficiency of which are hereby acknowledged), the Parties hereto covenant and agree as follows:

 

Article 1
INTERPRETATION

 

1.1 Definitions

 

In this Agreement, unless the context otherwise requires:

 

Acquisition Proposal ” means, other than the transactions contemplated by this Agreement, any bona fide offer, proposal or inquiry from any Person or group of Persons acting jointly or in concert, whether or not in writing and whether or not made public, made after the date hereof relating to: (a) any acquisition or purchase, direct or indirect, of: (i) all or any part of the assets comprising the Retained Assets held by Cardiome or any of its subsidiaries, or (ii) 20% or more of the issued and outstanding voting or equity securities of Cardiome; (b) any take-over bid, tender offer or exchange offer that, if consummated, would result in such Person or group of Persons beneficially owning 20% or more of the issued and outstanding voting or equity securities of Cardiome; or (c) any plan of arrangement, merger, amalgamation, consolidation, share exchange, business combination, reorganization, recapitalization, liquidation, dissolution or other similar transaction involving Cardiome or all or any part of the assets comprising the Retained Assets held by Cardiome or any of its subsidiaries but not such a transaction affecting solely the Assigned Assets; in all cases, whether in a single transaction or in a series of related transactions; provided, that, an Acquisition Proposal shall not include any bona fide offer, proposal or inquiry relating solely to the acquisition of Assigned Assets;

 

affiliate ” has the meaning ascribed thereto in the Securities Act;

 

 

 

  

Agreement ” means this arrangement agreement, including all schedules annexed hereto, together with the Cardiome Disclosure Letter, as the same may be amended, supplemented or otherwise modified from time to time, in accordance with the terms hereof;

 

Ancillary Agreements (Aggrastat) ” means, with respect to the Aggrastat product, collectively (i) a transition services agreement, and (ii) a supply agreement, in each case to be entered into between Correvio (and any affiliates of Correvio to the extent necessary or advisable) and Cardiome, containing terms and conditions consistent with the term sheets relating thereto as agreed to by the Parties as of the date hereof, together with such other terms and conditions as are typical for agreements of such nature and as may otherwise be agreed to by the Parties, each acting reasonably;

 

Ancillary Agreements (Brinavess) ” means, with respect to the Brinavess product, collectively (i) a transition services agreement, and (ii) a supply agreement, in each case to be entered into between Correvio (and any affiliates of Correvio to the extent necessary or advisable) and Cardiome, containing terms and conditions consistent with the term sheets relating thereto as agreed to by the Parties as of the date hereof, together with such other terms and conditions as are typical for agreements of such nature and as may otherwise be agreed to by the Parties, each acting reasonably;

 

Arrangement ” means the arrangement of Cardiome under Section 192 of the CBCA on the terms and subject to the conditions set out in the Plan of Arrangement, subject to any amendments or variations to the Plan of Arrangement made in accordance with the terms of this Agreement or Article 7 of the Plan of Arrangement or made at the direction of the Court in the Final Order with the consent of the Parties, each acting reasonably;

 

Articles of Arrangement ” means the articles of arrangement of Cardiome in respect of the Arrangement required by the CBCA to be filed with the Director after the Final Order is made, which shall be in form and content satisfactory to the Parties, each acting reasonably;

 

Assigned Assets ” means all of the assets, properties, interests and rights of Cardiome and its subsidiaries (of any nature or kind whatsoever), other than the Retained Assets;

 

Assignment and Assumption Agreement ” means the assignment and assumption agreement to be entered into on the Effective Date between Cardiome and Correvio, evidencing the assignment to and the assumption by Correvio of all of the Assumed Liabilities;

 

Assumed Liabilities ” means all of the Liabilities of Cardiome and its subsidiaries, other than the Retained Liabilities, whether arising before, as of, or after the Effective Time;

 

Authorization ” means any authorization, order, Permit, approval, grant, licence, registration, consent, right, notification, condition, franchise, privilege, certificate, judgment, writ, injunction, award, determination, direction, decision, decree, bylaw, rule or regulation, whether or not having the force of Law, and includes any Environmental Permit;

 

Books and Records ” means all information in any form relating to Cardiome (including all predecessor corporations) or the Retained Assets and Retained Liabilities, including books of account, financial, tax, business, marketing, personnel and research information and records, equipment logs, operating guides and manuals and all other documents, files, correspondence and other information;

 

Brinavess Assets ” means all patents, trademarks and goodwill owned by Cardiome related to the Brinavess product and the royalty agreement between Correvio International Sarl and Cardiome with respect to royalties on non-Canadian Brinavess, but not including any Canadian patents, trademarks and goodwill related to the Brinavess product;

 

Business Day ” means any day of the year, other than a Saturday, Sunday or any statutory holiday in Toronto, Ontario or Vancouver, British Columbia;

 

  - 2 -  

 

  

Cardiome Annual Financial Statements ” means the audited consolidated financial statements of Cardiome as at, and for the financial years ended, December 31, 2016 and December 31, 2015, including the notes thereto;

 

Cardiome Arrangement Resolution ” means the special resolution of the Cardiome Shareholders approving the Arrangement, the Plan of Arrangement and this Arrangement Agreement to be considered at the Cardiome Meeting, substantially in the form attached as Schedule B;

 

Cardiome Board ” means the board of directors of Cardiome, as the same is constituted from time to time;

 

Cardiome Circular ” means the notice of the Cardiome Meeting and accompanying management information circular, including all schedules, appendices and exhibits thereto and enclosures therewith, to be sent to the Cardiome Shareholders and other securityholders of Cardiome, as required, in connection with the Cardiome Meeting, as amended, supplemented or otherwise modified from time to time;

 

Cardiome Disclosure Documents ” means all information, disclosure, forms, reports, schedules, statements, certifications and other documents, including without limitation all press releases, forms, reports, schedules, financial statements and notes and schedules to such financial statements, management’s discussion and analysis of financial condition and operations, certifications, annual information forms, management information circulars, material change reports and other documents required to be publicly disclosed or filed by Cardiome with Securities Authorities pursuant to applicable Securities Laws, and which are available for review under Cardiome’s SEDAR profile at www.sedar.com ;

 

Cardiome Disclosure Letter ” means the disclosure letter executed by Cardiome and delivered to Cipher prior to or concurrently with the execution of this Agreement;

 

Cardiome Financial Advisor ” means Evans & Evans, Inc.;

 

Cardiome Financial Statements ” means, collectively, the Cardiome Annual Financial Statements and the Cardiome Interim Financial Statements;

 

Cardiome Interim Financial Statements ” means the unaudited consolidated interim financial statements of Cardiome as at, and for the three and nine months ended, September 30, 2017 and September 30, 2016, including the notes thereto;

 

Cardiome Material Contracts ” means any Contract to which Cardiome is a party or by which Cardiome is bound pursuant to which Cardiome has any material Liability or for which there is a reasonable potential for Cardiome to have a material Liability but shall not include any contract terminable with no additional consideration by Cardiome on 30 days or less notice to the counterparty. Without limiting the foregoing, the term “Cardiome Material Contact” shall include any:

 

(a) Contract concerning or relating to the Retained Assets (including the Intellectual Property Assets) or Retained Liabilities;

 

(b) lease or other Contract concerning or relating to real property leased by Cardiome;

 

(c) employment or consulting Contract with any officer, employee or consultant of Cardiome (except for employment or consulting contracts of indefinite hire or subject to automatic renewal entered into in the ordinary course of business);

 

(d) collective bargaining agreement or other Contract with any labour union;

 

  - 3 -  

 

  

(e) profit sharing, bonus, stock option, pension, retirement, disability, stock purchase, medical, dental, hospitalization, insurance or similar plan or agreement providing benefits to any current or former director, officer, employee or consultant of Cardiome;

 

(f) orders or other Contracts for the purchase of products, supplies, equipment or services which involves aggregate annual expenditures in excess of $50,000;

 

(g) orders or other Contracts for the sale of products, supplies, equipment or services which involves aggregate annual expenditures in excess of $25,000;

 

(h) loan or credit agreement, trust indenture, mortgage, promissory note or other Contract for the borrowing of money under which Cardiome has any obligations;

 

(i) agreement of guarantee, support, assumption or endorsement of, or any other similar commitment with respect to, the Liabilities of, or any agreement to provide financial assistance of any kind to, any other Person;

 

(j) Contract pursuant to which Cardiome has any continuing obligations relating to indemnification that could reasonably be expected to give rise to a Claim in excess of $25,000;

 

(k) commitment for charitable contributions;

 

(l) Contract providing for annual capital expenditures in excess of $25,000 in the aggregate;

 

(m) Contract for the sale of any assets, other than sales of inventory to customers in the ordinary course of business;

 

(n) Contract pursuant to which Cardiome is a lessor of any machinery, equipment, motor vehicles, office furniture, fixtures or other personal property which involves aggregate payments in excess of $25,000;

 

(o) any non-competition or similar Contract or any agreement that prohibits the ability of Cardiome to participate in any type of business or to conduct business in any geographic area;

 

(p) Contract with any officer, director, employee, consultant, shareholder or any other person not dealing at arm’s length with Cardiome (within the meaning of the Tax Act), except for employment or consultant contracts;

 

(q) Contract containing any “change in control”, “assignment” or other similar provisions that will be triggered by consummation of the transactions contemplated by this Agreement, including the Arrangement; or

 

(r) other Contract, not described above, under which Cardiome has any Liabilities or potential Liabilities in excess of $50,000 per annum in the aggregate.

 

Cardiome Meeting ” means the special meeting of Cardiome Shareholders, including any adjournment or postponement thereof, to be called and held in accordance with the Interim Order to consider the Cardiome Arrangement Resolution and for any other purpose as may be set out in the Cardiome Circular and agreed to by Cipher;

 

Cardiome Option Plan ” means the stock option plan of Cardiome, last approved by Cardiome Shareholders on June 20, 2017 ;

 

Cardiome Options ” means, at any time, options to acquire Cardiome Shares granted under the Cardiome Option Plan which are, at such time, outstanding and unexercised (whether or not vested);

 

  - 4 -  

 

  

Cardiome Shareholder Approval ” has the meaning ascribed thereto in Subsection 2.3(c);

 

Cardiome Shareholders ” means the holders of Cardiome Shares;

 

Cardiome Shares ” means issued and outstanding common shares in capital of Cardiome;

 

Cardiome Supporting Shareholders ” means, collectively, those senior officers and directors of Cardiome who have entered into Cardiome Voting Agreements;

 

Cardiome Termination Fee ” has the meaning ascribed thereto in Subsection 8.5(a);

 

Cardiome Voting Agreements ” means the voting agreements (including all amendments thereto) between Cipher and the Cardiome Supporting Shareholders setting forth the terms and conditions upon which they have agreed, among other things, to vote their Cardiome Shares in favour of the Cardiome Arrangement Resolution;

 

Cardiome Warrants ” means, at any time, purchase warrants to acquire Cardiome Shares which are, at such time, outstanding and unexercised;

 

CBCA ” means the Canada Business Corporations Act ;

 

Certificate of Arrangement ” means the certificate of arrangement to be issued by the Director pursuant to subsection 192(7) of the CBCA in respect of the Articles of Arrangement;

 

Change in Recommendation ” has the meaning ascribed thereto in Subsection 7.2(a)(iv);

 

Cipher Board ” means the board of directors of Cipher as the same is constituted from time to time;

 

Cipher Indemnified Parties ” has the meaning ascribed thereto in Subsection 9.1(a);

 

Claim ” means any demand, action, cause of action, investigation, inquiry, suit, proceeding, claim, complaint, arbitration, charge, prosecution, assessment or reassessment, including any appeal or application for review, judgment, arbitration, award, grievance, settlement or compromise;

 

Claim Notice ” has the meaning ascribed thereto in Section 9.4;

 

Confidentiality Agreement ” means the confidentiality agreement between the Parties made with effect as of October 23, 2017, as amended on February 1, 2018;

 

Consideration ” means the consideration to be received by Cardiome Shareholders (other than Dissenting Shareholders) for their Cardiome Shares pursuant to the Plan of Arrangement, consisting of one (1) Consideration Share for each one (1) Cardiome Share in accordance with the Exchange Ratio (subject to any adjustment of the Exchange Ratio);

 

Consideration Shares ” means the Correvio Shares to be issued in exchange for Cardiome Shares pursuant to the Arrangement;

 

Contract ” means any contract, agreement, license, franchise, lease, arrangement, commitment, understanding, joint venture, partnership or other right or obligation (written or oral) to which a Party or any of its subsidiaries is a party or by which a Party or any of its subsidiaries is bound or to which any of their respective properties or assets is subject;

 

  - 5 -  

 

  

Correvio ” means Correvio Pharma Corp., a corporation incorporated under the CBCA, that is and will be a wholly-owned subsidiary of Cardiome immediately prior to the Effective Time;

 

Correvio Canada ” means a corporation to be incorporated under the CBCA, that is and will be a wholly-owned subsidiary of Cardiome immediately prior to the Effective Time;

 

Correvio Canada Shares ” means issued and outstanding common shares in the capital of Correvio Canada;

 

Correvio Indemnified Parties ” has the meaning ascribed thereto in Subsection 9.2(a);

 

Correvio Replacement Option ” has the meaning ascribed thereto in Subsection 2.16(a);

 

Correvio Shares ” means the issued and outstanding common shares in the capital of Correvio;

 

Correvio Option Plan ” means the stock option plan of Correvio to be adopted by Correvio prior to the Effective Time, having identical terms and conditions to the Cardiome Option Plan (except all references to Cardiome shall be references to Correvio);

 

Court ” means the Supreme Court of British Columbia;

 

CRG Loan ” means the amended and restated term loan agreement dated as of May 11, 2017 among Cardiome and its senior lenders (and their agent, CRG Servicing LLC) and all agreements ancillary thereto;

 

Damages ” has the meaning ascribed thereto in Section 9.4;

 

Damages Claim ” has the meaning ascribed thereto in Section 9.4;

 

Depositary ” means Computershare Trust Company of Canada, appointed for the purpose of, among other things, exchanging certificates representing Cardiome Shares for certificates representing Consideration Shares;

 

Director ” means the Director appointed pursuant to Section 260 of the CBCA;

 

Direct Claim ” has the meaning ascribed thereto in Section 9.4;

 

Dissent Rights ” means the rights of dissent exercisable by the Cardiome Shareholders under Section 190 of the CBCA in respect of the Arrangement, as described in the Plan of Arrangement;

 

“Dissenting Shareholder ” has the meaning ascribed thereto in the Plan of Arrangement;

 

Effective Date ” means the date shown on the Certificate of Arrangement giving effect to the Arrangement, which shall be no later than the Outside Date;

 

Effective Time ” has the meaning ascribed thereto in the Plan of Arrangement;

 

Employee Obligations ” has the meaning ascribed thereto in Section 5.3;

 

Employee Plans ” means all benefit, bonus, incentive, pension, retirement, savings, stock purchase, profit sharing, stock option, stock appreciation, phantom stock, termination, change of control, life insurance, medical, health, welfare, hospital, dental, vision care, drug, sick leave, disability, and similar plans, programmes, arrangements or practices relating to any current or former director, officer or employee of Cardiome or any of its subsidiaries;

 

  - 6 -  

 

  

" Encumbrance " includes any mortgage, pledge, assignment, charge, lien, claim, security interest, adverse interest, adverse claim, other third person interest or encumbrance of any kind, whether contingent or absolute, and any agreement, option, right or privilege (whether by Law, Contract or otherwise) capable of becoming any of the foregoing;

 

Environmental Laws ” means all Laws aimed at, or relating to, the reclamation or restoration of properties, protection of the environment, abatement of pollution, protection of wildlife, ensuring public safety from environmental hazards, occupational health and safety, and all other Laws relating to the management processing, use, treatment, storage, disposal, discharge, transport or handling of any Hazardous Substances;

 

Environmental Permits ” means any Permits issued or required under any Environmental Law;

 

Exchange Ratio ” means a ratio of one (1) Consideration Share for each one (1) Cardiome Share; provided however, that the Cardiome Board may by resolution determine to adjust and set the number of Cardiome Shares in such ratio at any number between one (1) and ten (10) so as to permit compliance with any applicable stock exchange requirements;

 

Final Order ” means an order of the Court granted pursuant to Section 192 of the CBCA, in a form acceptable to the Parties, each acting reasonably, approving the Arrangement after a hearing upon the procedural and substantive fairness of the terms and conditions of the Arrangement, as such order may be affirmed, amended, modified, supplemented or varied by the Court (with the consent of the Parties, each acting reasonably) at any time prior to the Effective Date or, if appealed, as affirmed or amended (provided, however, that any such amendment is acceptable to the Parties, each acting reasonably) on appeal, unless such appeal is withdrawn, abandoned or denied;

 

Governmental Entity ” means (i) any multinational or supranational body or organization, nation, government, state, province, country, territory, municipality, quasi-government, administrative, judicial or regulatory authority, agency, board, body, bureau, commission, instrumentality, court or tribunal or any political subdivision thereof, or any central bank (or similar monetary or regulatory authority) thereof, any taxing authority, any ministry or department or agency of any of the foregoing, (ii) any self-regulatory organization or stock exchange, including the TSX and Nasdaq, (iii) any entity exercising executive, legislative, judicial, regulatory or administrative functions of or pertaining to government; and (iv) any corporation or other entity owned or controlled, through stock or capital ownership or otherwise, by any of such entities or other bodies pursuant to the foregoing;

 

Hazardous Substance ” means any waste or other substance that is prohibited, listed, defined, designated or classified as hazardous, radioactive, corrosive, explosive, infectious, carcinogenic, or toxic or a pollutant or a contaminant under or pursuant to, or that could result in any Liability under, any applicable Environment Laws including petroleum and all derivatives thereof or synthetic substitutes therefor, hydrogen sulphide, arsenic, cadmium, lead, mercury, polychlorinated biphenyls (“ PCBs ”), PCB-containing equipment and material, mould, asbestos, asbestos-containing material, urea-formaldehyde, urea-formaldehyde-containing material and any other material or substance that may impair the environment;

 

Holdback Amount ” means an amount equal to (i) $1,000,000, if all of the conditions referenced in Subsections 6.1(i), 6.1(j) and 6.1(k) have been satisfied on prior to the Effective Time, or (ii) $2,500,000, in any other case, which amount forms part of the Share Purchase Consideration and shall be paid to Correvio pursuant to the terms and conditions of Section 9.9;

 

including ” means including without limitation, and “ include ” and “ includes ” have a corresponding meaning;

 

Indemnification Claim ” has the meaning ascribed thereto in Section 9.4;

 

Indemnified Party ” means a Cardiome Indemnified Party or Cipher Indemnified Party, as applicable;

 

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Intellectual Property Assets ” means the Intellectual Property Rights owned or licensed by Cardiome which form part of the Retained Assets, as listed in Schedule C(x) of the Cardiome Disclosure Letter;

 

Intellectual Property Rights ” means all rights in intellectual property and industrial property, whether or not registrable, patentable or otherwise formally protectable, and whether or not registered, patented, otherwise formally protected or the subject of a pending application for registration, patent or any other formal protection, including all rights, titles, interests, and benefits in and to (a) trade-marks, trade dress, corporate, partnership and business names and other trade names, (b) inventions, patent rights, arts, processes, machines, manufactures, compositions of matter, (c) copyrights, software and databases, (d) designs and industrial designs, (e) know-how, trade secrets, proprietary information, formulae, recipes, systems, methods and techniques and related documentation, customer and supplier information, and market and survey information, (f) telephone numbers, domain names and social media identities, and all derivatives, modifications and improvements of the foregoing;

 

Inter-company Agreements ” means any agreements between Cardiome and one or more of its subsidiaries;

 

Interim Order ” means an order of the Court in a form acceptable to the Parties, each acting reasonably, providing for, among other things, the calling and holding of the Cardiome Meeting, as the same may be amended by the Court with the consent of the Parties, each acting reasonably;

 

Key Regulatory Approvals ” means those sanctions, rulings, consents, orders, exemptions, permits and other approvals of Governmental Entities, necessary to proceed with the transactions contemplated by this Agreement and the Plan of Arrangement, including but not limited to, in relation to Cardiome, the approval of the TSX and Nasdaq in respect of the Arrangement and the grant of the Interim Order and the Final Order, as listed in Schedule C(i) of the Cardiome Disclosure Letter;

 

Key Third Party Consents ” means those notices, consents or approvals required to be delivered to or obtained from any third party (other than any Governmental Entity), including under any Contract, to proceed with the transactions contemplated by this Agreement and the Plan of Arrangement, as listed in Schedule C(i) of the Cardiome Disclosure Letter;

 

Law ” means, with respect to any Person, any and all applicable law (statutory, common or otherwise), constitution, treaty, convention, ordinance, code, rule, regulation, order, injunction, judgment, decree, ruling or other similar requirement, whether domestic or foreign, enacted, adopted, promulgated or applied by a Governmental Entity that is binding upon or applicable to such Person or its business, undertaking, property or securities, and to the extent that they have the force of law, policies, guidelines, notices and protocols of any Governmental Entity, as amended;

 

" Liability " means, in respect of any Person, any debt, liability or obligation of any kind or nature whatsoever, including (i) any right against such Person to payment, whether or not such right is reduced to judgment, liquidated, unliquidated, fixed, contingent, matured, unmatured, disputed, undisputed, legal, equitable, secured or unsecured, (ii) any right against such Person to an equitable remedy for breach of performance if such breach gives rise to a right to payment, whether or not such right to any equitable remedy is reduced to judgment, fixed, contingent, matured, unmatured, disputed, undisputed, secured or unsecured, and (iii) any obligation of such Person for the performance of any covenant or agreement (whether for the payment of money or otherwise);

 

Losses ” means any and all loss, liability, damage, cost, expense, charge, fine, penalty or assessment, interest charges, punitive damages, fines, penalties and reasonable professional fees and disbursements, including in connection with any Claim;

 

  - 8 -  

 

  

Material Adverse Effect ” means any effect that is, or would reasonably be expected to be, material and adverse to the Retained Assets or Retained Liabilities, taken as a whole, or the business, condition (financial or otherwise), properties, assets (tangible or intangible), liabilities (whether absolute, accrued, conditional or otherwise), operations or results of operations of Cardiome and its subsidiaries, taken as a whole, other than any effect relating to or affecting, as applicable (i) the Canadian economy, political conditions (including the outbreak of war or any acts of terrorism) or securities markets in general, (ii) the pharmaceutical industry in general, (iii) any generally applicable change in Laws (other than orders, judgments or decrees against Cardiome or any of its subsidiaries), or (iv) a change in the market trading price of the Cardiome Shares that is either (A) related to this Agreement and the Arrangement or the announcement thereof, or (B) primarily a result of a change, effect, event or occurrence excluded from this definition of Material Adverse Effect referred to in clause (i), (ii) or (iii) above; provided, however, that the effect referred to in clause (i), (ii) or (iii) above does not primarily relate to (or have the effect of primarily relating to) Cardiome and its subsidiaries, taken as a whole, or disproportionately adversely affect Cardiome and its subsidiaries, taken as a whole, compared to other companies of similar size operating in the industry in which Cardiome and its subsidiaries operate;

 

material change ”, “ material fact ” and “ misrepresentation ” have the meanings ascribed thereto in the Securities Act;

 

MI 61-101 ” means Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions ;

 

Moved SARL Plus SA Assets ” means those assets listed Schedule J;

 

Moved Trevyent Assets ” means those assets listed in Schedule I;

 

Nasdaq ” means the Nasdaq Capital Market;

 

New Canadian Product ” has the meaning ascribed thereto in Subsection 7.6(a);

 

Notice of Acceptance ” has the meaning ascribed thereto in Subsection 7.6(b);

 

ordinary course of business ”, “ ordinary course of business consistent with past practice ”, or any similar reference, means, with respect to an action taken by a Person, that such action is consistent with the past practices of such Person and is taken in the ordinary course of the normal day-to-day business and operations of such Person; provided that in any event such action is not unreasonable or unusual;

 

Offered Interest ” has the meaning ascribed thereto in Subsection 7.6(a);

 

Office Lease ” means the office lease agreement between Cardiome and Central 1 Credit Union dated July 23, 2014;

 

Option Period ” has the meaning ascribed thereto in Subsection 7.6(b);

 

Outside Date ” means June 30, 2018 or such later date as may be agreed to in writing by the Parties;

 

Parties ” means, collectively, Cardiome, Correvio and Cipher and “ Party ” means any one of them;

 

Permit ” means any license, permit, certificate, consent, order, grant, approval, agreement, classification, restriction, registration or other Authorization of, from or required by any Governmental Entity;

 

Person ” includes any individual, firm, partnership, limited partnership, limited liability partnership, joint venture, venture capital fund, limited liability company, unlimited liability company, association, trust, trustee, executor, administrator, legal personal representative, estate, body corporate, corporation, company, unincorporated association or organization, Governmental Entity, syndicate or other entity, whether or not having legal status;

 

  - 9 -  

 

  

Plan of Arrangement ” means the plan of arrangement of Cardiome, substantially in the form attached as Schedule A, and any amendments or variations thereto made from time to time in accordance with this Agreement, the Plan of Arrangement or upon the direction of the Court in the Interim Order or the Final Order with the consent of the Parties, each acting reasonably;

 

Pre-Closing Reorganization ” has the meaning ascribed thereto in Subsection 2.17(a);

 

PSU Plan ” means Cardiome’s 2014 Phantom Share Unit Plan adopted with effect from December 6, 2014;

 

PSUs ” means, as of any date, phantom share units issued under the PSU Plan outstanding as of such date;

 

Representative ” means, collectively, in respect of a Person, its subsidiaries and its affiliates and its and their respective officers, directors, employees, consultants, advisors, agents or other representatives (including financial, legal or other advisors);

 

Retained Assets ” means only those assets listed in Schedule F and includes the Books and Records;

 

Retained Employees ” means only those employees of Cardiome or its subsidiaries listed in Schedule H;

 

Retained Liabilities ” means only those Liabilities listed in Schedule G;

 

Right of First Refusal ” has the meaning ascribed thereto in Subsection 7.6(b);

 

RSU Plan ” means Cardiome’s Amended Restricted Share Unit Plan adopted with effect from May 9, 2014;

 

RSUs ” means, as of any date, restricted share units issued under the RSU Plan outstanding as of such date;

 

SEC ” means the U.S. Securities and Exchange Commission;

 

Securities Act ” means the Securities Act (British Columbia) and the rules, regulations and published policies made thereunder, as now in effect and as they may be promulgated or amended from time to time;

 

Securities Authorities ” means all applicable securities regulatory authorities, including the applicable securities commissions or similar regulatory authorities in each of the provinces and territories of Canada and the TSX, Nasdaq and the SEC;

 

Securities Laws ” means the Securities Act, together with all other applicable Canadian provincial securities laws, the U.S. Securities Act, U.S. Exchange Act, and applicable securities laws of the United States and the states thereof, and the rules and regulations and published policies of the securities authorities thereunder, as now in effect and as they may be promulgated or amended from time to time, and includes the rules and policies of the TSX and Nasdaq;

 

Share Purchase Consideration ” means an amount equal to $25,500,000 to be paid by Cipher to Correvio as payment for all of the outstanding Cardiome Shares held by Correvio pursuant to the terms of the Arrangement (inclusive, for greater certainty, of the Holdback Amount);

 

Sublicense Agreement (Trevyent) ” means a sublicense and supply agreement to be entered into between Correvio International Sarl and Cardiome, in substantially the form agreed to by the Parties as of the date hereof (and as approved by SteadyMed Ltd.), pursuant to which Cardiome will be granted certain rights with respect of the commercialization of Trevyent® (a drug device combination that delivers Remodulin® (treprostinil)) in Canada;

 

  - 10 -  

 

  

Sublicense Agreement (Xydalba) ” means a sublicense and supply agreement to be entered into between Correvio International Sarl and Cardiome, in substantially the form agreed to by the Parties as of the date hereof (and as approved by Allergan Pharmaceuticals International Limited), pursuant to which Cardiome will be granted certain rights with respect of the commercialization of Xydalba™ (dalbavancin hydrochloride) in Canada;

 

subsidiary ” has the meaning ascribed thereto in the Securities Act;

 

Superior Proposal ” means any bona fide Acquisition Proposal that relates to the acquisition of 100% of the outstanding Cardiome Shares, made in writing by a third party or third parties acting jointly or in concert with one another, who deal at arm’s length to Cardiome, that in the good faith determination of the Cardiome Board, after receipt of advice from its outside financial advisor and legal counsel: (i) is reasonably capable of being completed in accordance with its terms without undue delay, taking into account all legal, financial, regulatory and other aspects of such proposal and the party making such proposal; (ii) in respect of which any required financing to complete such Acquisition Proposal has been demonstrated to be available; (iii) is not subject to a due diligence or access condition; (iv) did not result from a breach of Article 7; (v) is made available to all Cardiome Shareholders on the same terms and conditions; (vi) failure to recommend such Acquisition Proposal to the Cardiome Shareholders would be inconsistent with the Cardiome Board’s fiduciary duties; and (vii) taking into account all of the terms and conditions of such Acquisition Proposal, if consummated in accordance with its terms (but not assuming away any risk of non-completion), would result in a transaction more favourable to Cardiome Shareholders, from a financial point of view, than the Arrangement (after taking into account any adjustment to the terms and conditions of the Arrangement proposed by Cipher pursuant to Section 7.3);

 

Superior Proposal Notice ” has the meaning ascribed thereto in Subsection 7.3(a)(iv);

 

Superior Proposal Notice Period ” has the meaning ascribed thereto in Subsection 7.3(a)(iv);

 

Tax Act ” means the Income Tax Act (Canada) and the regulations made thereunder, as now in effect and as they may be promulgated or amended from time to time;

 

Tax Returns ” means all returns, reports, declarations, elections, notices, filings, forms, statements and other documents (whether in tangible, electronic or other form) and including any amendments, schedules, attachments, supplements, appendices and exhibits thereto, made, prepared, filed or required to be made, prepared or filed by Law in respect of Taxes;

 

Taxes ” means any and all domestic and foreign federal, state, provincial, municipal and local taxes, assessments and other governmental charges, duties, impositions and liabilities imposed by any Governmental Entity, including without limitation pension plan contributions, tax instalment payments, unemployment insurance contributions and employment insurance contributions, workers’ compensation and deductions at source, including taxes based on or measured by gross receipts, income, profits, sales, capital, use, and occupation, and including goods and services, value added, ad valorem, sales, capital, transfer, franchise, non-resident withholding, customs, payroll, recapture, employment, excise and property duties and taxes, together with all interest, penalties, fines and additions imposed with respect to such amounts;

 

Termination Payment ” means an amount equal to $2,500,000;

 

Termination Payment Event ” has the meaning ascribed thereto in Subsection 8.4(a);

 

Third Party Claim ” has the meaning ascribed thereto in Section 9.4;

 

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Transfer Agreement ” means the transfer agreement / bill of sale to be entered into on the Effective Date, between the Cardiome and Correvio, which effects the sale, conveyance, grant, transfer and assignment to Correvio of all of Cardiome’s, right, title or interest in or to the Assigned Assets;

 

Transfer Offer ” has the meaning ascribed thereto in Subsection 7.6(a);

 

Transaction Personal Information ” has the meaning ascribed thereto in Section 10.1;

 

TSX ” means the Toronto Stock Exchange;

 

United States ” means the United States of America, its territories and possessions, any state of the United States and the District of Columbia;

 

U.S. Exchange Act ” means the United States Securities Exchange Act of 1934 , as amended and the rules and regulations promulgated thereunder;

 

U.S. GAAP ” means United States generally accepted accounting principles;

 

U.S. Securities Act ” means the United States Securities Act of 1933 , as amended and the rules and regulations promulgated thereunder; and

 

U.S. Tax Code ” has the meaning ascribed thereto in Section 2.14;

 

1.2 Interpretation

 

For the purposes of this Agreement, except as otherwise expressly provided:

 

(a) this Agreement ” means this Arrangement Agreement, including the recitals and Schedules hereto, and not any particular Article, Section, Subsection or other subdivision, recital or Schedule hereof, and includes any agreement, document or instrument entered into, made or delivered pursuant to the terms hereof, as the same may, from time to time, be supplemented or amended and in effect;

 

(b) the words “ hereof ”, “ herein ”, “ hereto ” and “ hereunder ” and other words of similar import refer to this Agreement as a whole and not to any particular Article, Section, Subsection, or other subdivision, recital or Appendix hereof;

 

(c) all references in this Agreement to a designated “ Article ”, “ Section ”, “ Subsection ” or other subdivision, recital or “ Schedule ” hereof are references to the designated Article, Section, Subsections or other subdivision, recital or Schedule to, this Agreement;

 

(d) the division of this Agreement into Article, Sections, Subsections and other subdivisions, recitals or Schedule, the inclusion of a table of contents and the insertion of headings and captions are for convenience of reference only and are not intended to interpret, define or limit the scope, extent or intent of this Agreement or any provision hereof;

 

(e) a reference to a statute in this Agreement includes all regulations, rules, policies or instruments made thereunder, all amendments to the statute, regulations, rules, policies or instruments in force from time to time, and any statutes, regulations, rules, policies or instruments that supplement or supersede such statute, regulations, rules, policies or instruments; and

 

(f) the word “including” is not limiting, whether or not non-limiting language (such as “without limitation” or “but not limited to” or words of similar import) is used with reference thereto.

 

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1.3 Number, Gender and Persons

 

In this Agreement, unless the context otherwise requires, words importing the singular shall include the plural and vice versa, words importing the use of either gender shall include both genders and neuters and the word person and words importing persons shall include a natural person, firm, trust, partnership, association, corporation, joint venture or government (including any governmental agency, political subdivision or instrumentality thereof) and any other entity or group of persons of any kind or nature whatsoever.

 

1.4 Date for Any Action

 

If the date on which any action is required to be taken hereunder by a Party is not a Business Day, such action shall be required to be taken on the next succeeding day which is a Business Day.

 

1.5 Currency

 

Unless otherwise stated, all references in this Agreement to sums of money are expressed in lawful money of Canada and “$” refers to Canadian dollars. All references to US$ refers to Untied States dollars.

 

1.6 Accounting Matters

 

Unless otherwise stated, all accounting terms used in this Agreement in respect of Cardiome shall have the meanings attributable thereto under U.S. GAAP and all determinations of an accounting nature in respect of Cardiome required to be made shall be made in a manner consistent with U.S. GAAP consistently applied.

 

1.7 Knowledge

 

Where any representation or warranty is expressly qualified by reference to the knowledge of Cardiome, it shall be deemed to refer to the actual knowledge, after making reasonable inquiries regarding the relevant subject matter, of any of William Hunter (President and Chief Executive Officer), Justin Renz (Chief Financial Officer), David Dean (Chief Business Development Officer) and David McMasters (General Counsel).

 

1.8 Schedules

 

The following Schedules are annexed to this Agreement and are incorporated by reference into this Agreement and form a part hereof:

 

Schedule A – Plan of Arrangement

 

Schedule B – Cardiome Arrangement Resolution

 

Schedule C – Representations and Warranties of Cardiome

 

Schedule D – Representations and Warranties of Correvio

 

Schedule E – Representations and Warranties of Cipher

 

Schedule F – Retained Assets

 

Schedule G – Retained Liabilities

 

Schedule H – Retained Employees

 

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Schedule I – Moved Trevyent Assets

 

Schedule J – Moved SARL Plus SA Assets

 

Article 2
THE ARRANGEMENT

 

2.1 Arrangement

 

The Parties agree that the Arrangement will be implemented in accordance with and subject to the terms and conditions contained in this Agreement and the Plan of Arrangement.

 

2.2 Obligations

 

(a) Subject to the terms and conditions of this Agreement, in order to facilitate the Arrangement, Cardiome will take all action reasonably necessary in accordance with all applicable Laws, including Securities Laws, to:

 

(i) to make and diligently prosecute a motion to the Court for the Interim Order in connection with the application for the Final Order in respect of the Arrangement;

 

(ii) in accordance with the terms of and the procedures contained in the Interim Order, duly call, give notice of, convene and hold the Cardiome Shareholder Meeting as soon as practicable, and in any event not later than May 23, 2018, to vote upon the Arrangement;

 

(iii) solicit proxies of the Cardiome Shareholders in favour of the Cardiome Arrangement Resolution and against any resolution submitted by any Person that is inconsistent with the Cardiome Arrangement Resolution and the completion of any of the transactions contemplated by this Agreement;

 

(iv) provide Cipher with copies of or access to information regarding the Cardiome Shareholder Meeting generated by any dealer and/or proxy solicitation agent, as requested from time to time by Cipher;

 

(v) consult with Cipher in fixing the date of the Cardiome Shareholder Meeting, give notice to Cipher of the Cardiome Shareholder Meeting and allow Cipher’s Representatives (including legal counsel) to attend the Cardiome Shareholder Meeting;

 

(vi) not change the record date for the Cardiome Shareholders entitled to vote at the Cardiome Shareholder Meeting, including in connection with any adjournment or postponement of the Cardiome Shareholder Meeting, unless required by applicable Law;

 

(vii) subject to obtaining the approvals as contemplated in the Interim Order and as may be directed by the Court in the Interim Order, take all steps necessary or desirable to submit the Arrangement to the Court and appear at Court to seek the Final Order as soon as reasonably practicable (and, in any event, within five (5) Business Days following the approval of the Cardiome Shareholder Meeting); and

 

(viii) deliver the Articles of Arrangement to the Director in accordance with Section 2.8 upon satisfaction or waiver of the conditions set out in Article 6.

 

2.3 Interim Order

 

As soon as reasonably practicable, Cardiome shall apply to the Court in a manner and on terms acceptable to Cipher, acting reasonably, pursuant to Section 192 of the CBCA and, in cooperation with Cipher, prepare, file and diligently pursue an application for the Interim Order, which shall provide, among other things:

 

  - 14 -  

 

  

(a) for the class of Persons to whom notice is to be provided in respect of the Arrangement and the Cardiome Meeting and for the manner in which such notice is to be provided;

 

(b) fix the record date for the purposes of determining the Cardiome Shareholders entitled to receive notice of and vote at the Cardiome Meeting;

 

(c) that the requisite approval for the Cardiome Arrangement Resolution shall be at least two-thirds of the votes cast by the Cardiome Shareholders present in person or by proxy at the Cardiome Meeting and such other approval, if any, as is required pursuant to MI 61-101 (the “ Cardiome Shareholder Approval ”);

 

(d) that, in all other respects, the terms, conditions and restrictions of the constating documents of Cardiome, including quorum requirements and other matters, shall apply in respect of the Cardiome Meeting;

 

(e) for the grant of Dissent Rights to the Cardiome Shareholders who are registered Cardiome Shareholders, as set out in the Plan of Arrangement;

 

(f) that the Cardiome Meeting may be adjourned or postponed from time to time by Cardiome subject to the terms of this Agreement without the need for additional approval of the Court;

 

(g) for the notice requirements with respect to the presentation of the application to the Court for the Final Order;

 

(h) that the record date for Cardiome Shareholders entitled to notice of and to vote at the Cardiome Meeting will not change in respect of any adjournment(s) of the Cardiome Meeting, unless required pursuant to applicable Securities Laws;

 

(i) that the Parties intend to rely upon the exemption from registration provided by Section 3(a)(10) of the U.S. Securities Act with respect to the issuance of the Consideration Shares and the Correvio Replacement Options to be issued pursuant to the Arrangement;

 

(j) that each Cardiome Shareholder and holder of Cardiome Options shall have the right to appear before the Court at the hearing of the Court to approve the application for the Final Order so long as they enter a notice of appearance within a reasonable time; and

 

(k) for such other matters as Cipher and/or Cardiome may reasonably require, subject to obtaining the prior consent of Cardiome and/or Cipher, respectively, such consent not to be unreasonably withheld or delayed.

 

2.4 Cardiome Meeting

 

Subject to the terms of this Agreement:

 

(a) Cardiome agrees to convene and conduct the Cardiome Meeting in accordance with the Interim Order, the constating documents of Cardiome and applicable Law as soon as practicable with a current target date of May 9, 2018, and in any event not later than May 23, 2018.

 

(b) Cardiome shall not adjourn, postpone or cancel (or propose or permit the adjournment, postponement or cancellation of) the Cardiome Meeting without Cipher’s prior written consent, except:

 

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(i) as required for quorum purposes (in which case the meeting will be adjourned and not cancelled) or by applicable Law or by a Governmental Entity; or

 

(ii) as otherwise required or permitted under this Agreement;

 

provided, however, that, if Cardiome provides Cipher with a Superior Proposal Notice prior to the Cardiome Meeting, Cardiome may, and shall upon the request of Cipher, adjourn the Cardiome Meeting to a date that is not less than five (5) Business Days and not more than fifteen (15) days after the date of the Superior Proposal Notice.

 

(c) Cardiome will advise Cipher from time to time as Cipher may reasonably request, and at least on a daily basis on each of the last ten (10) Business Days prior to the date of the Cardiome Meeting, as to the aggregate tally of the proxies received by Cardiome in respect of the Cardiome Arrangement Resolution.

 

(b) Cardiome will promptly advise Cipher of any written communication from or written claims brought by (or threatened, orally or in writing, to be brought by) any Person in opposition to the Arrangement and/or purported exercise by any Cardiome Shareholder of Dissent Rights received by Cardiome and any withdrawal of Dissent Rights received by Cardiome and any written communications sent by or on behalf of Cardiome to any Cardiome Shareholder exercising or purporting to exercise Dissent Rights. Cardiome shall not settle or compromise, or agree to settle or compromise, any such claims without the prior written consent of Cipher, not to be unreasonably withheld or delayed.

 

(c) Except as required by applicable Laws, Cardiome will not propose or submit for consideration at the Cardiome Shareholder Meeting any business other than the Arrangement and the approval of the Cardiome Arrangement Resolution without Cipher’s prior written consent, which consent shall not be unreasonably withheld or delayed.

 

2.5 Cardiome Circular

 

(a) As soon as reasonably practicable following execution of this Agreement, but subject to Subsection 2.5(c), Cardiome shall (i) prepare, in consultation with Cipher, the Cardiome Circular, together with any other documents required by applicable Laws, and (ii) cause the Cardiome Circular to be sent to Cardiome Shareholders and holders of Cardiome Options and filed in all jurisdictions where the same is required to be filed, all in accordance with all applicable Laws and the Interim Order. Cardiome shall ensure that the Cardiome Circular complies in all material respects with all applicable Laws and, without limiting the generality of the foregoing, that the Cardiome Circular represents full, true and plain disclosure of all material facts concerning Cardiome and does not include any misrepresentation (other than with respect to any information relating solely to Cipher and provided by Cipher for inclusion in the Cardiome Circular) and contains sufficient detail to permit the Cardiome Shareholders to form a reasoned judgement concerning the matters to be placed before them at the Cardiome Meeting.

 

(b) Cardiome shall disclose in the Cardiome Circular:

 

(i) that the Cardiome Board has received a fairness opinion from the Cardiome Financial Advisor that the Arrangement is fair, from a financial point of view, to the Cardiome Shareholders;

 

(ii) the general terms of the fairness opinion from the Cardiome Financial Advisor and such fairness opinion shall be included in the Cardiome Circular;

 

(iii) that the Cardiome Board has unanimously determined, after receiving financial and legal advice, that (i) the Arrangement is fair and reasonable to the Cardiome Shareholders, (ii) the Arrangement is in the best interests of Cardiome, and (iii) the Cardiome Board recommends that the Cardiome Shareholders vote in favour of the Cardiome Arrangement Resolution; and

 

  - 16 -  

 

  

(iv) that each director and senior officer of Cardiome intends to vote all of such Person’s Cardiome Shares (including any Cardiome Shares issued upon the exercise of any securities convertible, exercisable or exchangeable into Cardiome Shares) in favour of the Cardiome Arrangement Resolution, subject to the other terms of this Agreement and the Cardiome Voting Agreements.

 

(c) Cipher shall promptly provide to Cardiome all information regarding Cipher or its subsidiaries and affiliates, as required by the Interim Order and applicable Laws for inclusion in the Cardiome Circular, or in any amendments or supplements to such Cardiome Circular. Cipher shall ensure that no such information provided by Cipher for inclusion in the Cardiome Circular will contain any misrepresentation concerning Cipher.

 

(d) Cipher and its legal counsel shall be given a reasonable opportunity to review and comment on the Cardiome Circular and all such other documents and the Cardiome Circular and all such other documents shall be in form and substance satisfactory to Cipher, acting reasonably, before they are printed and mailed to Cardiome Shareholders or filed with any Governmental Entity, subject to any disclosure obligations imposed on Cardiome by any Securities Authorities.

 

(e) Each of Cardiome and Cipher shall promptly notify the other Party if at any time before the Effective Date either becomes aware that the Cardiome Circular contains a misrepresentation, or otherwise requires an amendment or supplement, and the Parties shall co-operate in the preparation of any amendment or supplement to the Cardiome Circular as required or appropriate, and Cardiome shall promptly mail or otherwise publicly disseminate any amendment or supplement to the Cardiome Circular to Cardiome Shareholders and, if required by the Court or applicable Laws, file the same with any Governmental Entity and as otherwise required.

 

(f) Cardiome shall keep Cipher informed of any material requests or comments made by any Securities Authorities in connection with the Cardiome Circular and promptly provide Cipher with copies of any correspondence received by Cardiome from, or sent by Cardiome to, any Securities Authorities in connection with the Cardiome Circular.

 

2.6 Final Order

 

If the Interim Order is obtained and the Cardiome Arrangement Resolution is passed at the Cardiome Meeting as required by applicable Law then, subject to the terms of this Agreement, Cardiome shall as soon as practicable (and, in any event, within five (5) Business Days following the approval of the Cardiome Shareholder Meeting) apply to the Court for the Final Order pursuant to Section 192(4)(e) of the CBCA approving the Arrangement on terms reasonably satisfactory to each of Cardiome and Cipher.

 

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2.7 Court Proceedings

 

Cardiome will provide Cipher and its legal counsel with a reasonable opportunity to review and comment upon drafts of all material to be filed with the Court in connection with the Interim Order and the Final Order, and will give reasonable consideration to all such comments. Subject to applicable Law, Cardiome will not file any material with the Court in connection with the Interim Order and the Final Order, or serve any such material, and will not agree to modify or amend materials so filed or served, except as contemplated by this Agreement, the Plan of Arrangement, or with Cipher’s prior written consent, such consent not to be unreasonably withheld, conditioned or delayed; provided, however, that nothing herein shall require Cipher to agree or consent to any increase in the Share Purchase Consideration or other modification or amendment to such filed or served materials that expands or increases Cipher’s obligations set forth in any such filed or served materials or under this Agreement or the Plan of Arrangement, or diminishes or limits Cipher’s and/or Cardiome’s rights in respect of the Retained Assets following the Effective Time. Cardiome shall also provide to Cipher and to Cipher’s legal counsel on a timely basis copies of any notice of appearance or other Court documents served on Cardiome in respect of the application for the Interim Order or the Final Order or any appeal therefrom and of any notice, whether written or oral, received by Cardiome indicating any intention to oppose the granting of the Interim Order or the Final Order or to appeal the Interim Order or the Final Order. Cardiome will ensure that all materials filed with the Court in connection with the Interim Order and the Final Order, are consistent in all material respects with the terms of this Agreement and the Plan of Arrangement. In addition, Cardiome will not object to legal counsel to Cipher making such submissions on the hearing of the motion for the Interim Order and the application for the Final Order as such counsel considers appropriate, provided, however, that Cardiome is advised of the nature of any submissions prior to the hearing and such submissions are consistent with this Agreement and the Plan of Arrangement. Cardiome will also oppose any proposal from any party that the Final Order contain any provision inconsistent with this Agreement, and, if at any time after the issuance of the Final Order and prior to the Effective Date, Cardiome is required by the terms of the Final Order or by Law to return to Court with respect to the Final Order, it shall do so after notice to, and in consultation and cooperation with, Cipher.

 

2.8 Articles of Arrangement and Effective Date

 

(a) The Articles of Arrangement shall implement the Plan of Arrangement and will become effective as of the Effective Time. On the second (2 nd ) Business Day after the satisfaction or, where permitted, the waiver of the conditions (excluding conditions that, by their terms, cannot be satisfied until the Effective Date, but subject to the satisfaction or, where not prohibited, the waiver of those conditions as of the Effective Date) set forth in Article 6, unless another time or date is agreed to in writing by the Parties, the Articles of Arrangement shall be filed by Cardiome with the Director, provided, however, that the Articles of Arrangement shall not be sent to the Director, for endorsement and filing by the Director, except as contemplated hereby or with Cipher’s prior written consent. From and after the Effective Time, the Plan of Arrangement will have all of the effects provided by applicable Law, including the CBCA. Each of Cardiome and Cipher agrees to amend the Plan of Arrangement at any time prior to the Effective Time in accordance with Section 8.6 of this Agreement to include such other terms determined to be reasonably necessary or desirable by Cipher or Cardiome, as the case may be, provided, however, that the Plan of Arrangement shall not be amended in any manner which has the effect of changing the Share Purchase Consideration or the Consideration, or which is otherwise prejudicial to the Cardiome Shareholders or other parties to be bound by the Plan of Arrangement or is inconsistent with the provisions of this Agreement.

 

(b) The closing of the Arrangement will take place at the offices of Blake, Cassels & Graydon LLP in Vancouver, British Columbia at 10:00 a.m. (Vancouver time) on the Effective Date, or at such other time and place as may be agreed to by the Parties. The Parties acknowledge that the Effective Date is currently targeted to occur on May 14, 2018,

 

2.9 Payment of Consideration

 

(a) Correvio will, following receipt by Cardiome of the Final Order and prior to the filing by Cardiome of the Articles of Arrangement, deposit in escrow with the Depositary sufficient Consideration Shares to pay the aggregate Consideration payable by Correvio to Cardiome Shareholders on the Effective Date pursuant to the Plan of Arrangement.

 

(b) Cipher will, following receipt by Cardiome of the Final Order and prior to the filing by Cardiome of the Articles of Arrangement, make arrangements satisfactory to Correvio, acting reasonably, to pay the aggregate Share Purchase Consideration (less the Holdback Amount calculated in accordance with Section 9.9) to Correvio, in immediately available funds, on the Effective Date pursuant to the Arrangement.

 

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2.10 Announcements and Consultations

 

Cipher and Cardiome shall consult with each other in respect to issuing any press release, preparing any presentations or otherwise making any public statement with respect to this Agreement or the Arrangement and in making any filing with any Governmental Entity with respect to this Agreement or the Arrangement. Each of Cipher and Cardiome shall use commercially reasonable efforts to enable the other Party to review and comment on all such press releases, presentations, public statements and filings prior to the release or filing, respectively, thereof, and neither Cipher nor Cardiome shall release, make or file any press release, presentation, public statements or filing without the prior written consent of the other Party (which consent shall not be unreasonably withheld or delayed); provided, however, that the obligations herein shall not prevent a Party from making such disclosure as is required by applicable Laws or the rules and policies of any applicable stock exchange, and the Party making such disclosure shall use all commercially reasonable efforts to enable the other Party to review or comment on the disclosure or filing, and if such prior notice is not possible, to give such notice immediately following the making of such disclosure or filing. Reasonable consideration shall be given to any comments made by the other Party and its counsel.

 

2.11 Withholding Taxes

 

The Parties, the Depositary and any Person on their behalf shall be entitled to deduct and withhold from any consideration payable or otherwise deliverable to any Person hereunder and from all dividends, interest or other amounts payable to any Person (including, for greater certainty, any Cardiome Shareholder, any Dissenting Shareholder, any holder of RSUs or any holder of PSUs) such amounts as any of the Parties or the Depositary or any Person on their behalf may be required or permitted to deduct and withhold therefrom under any provision of applicable Laws in respect of Taxes. To the extent that such amounts are so deducted, withheld and remitted, such amounts shall be treated for all purposes under this Agreement as having been paid to the Person to whom such amounts would otherwise have been paid. The Parties and the Depositary shall also have the right to withhold and sell, on their own account or through a broker, and on behalf of any aforementioned Person to whom a withholding obligation applies, or require such Person to irrevocably direct the sale through a broker and irrevocably direct the broker to pay the proceeds of such sale to the Parties or the Depositary, as appropriate, such number of Consideration Shares issued to such Person pursuant to the Arrangement as is necessary to produce sale proceeds (after deducting commissions payable to the broker and other costs and expenses) sufficient to fund any withholding obligations. None of the Parties or the Depositary will be liable for any Loss arising out of any sale.

 

2.12 List of Shareholders

 

Subject to Section 10.1, at the reasonable request of Cipher from time to time, Cardiome shall provide Cipher with a list (in both written and electronic form) of the registered Cardiome Shareholders, together with their addresses and respective holdings of Cardiome Shares, with a list of the names and addresses and holdings of all Persons having rights issued by Cardiome to acquire Cardiome Shares and a list of non-objecting beneficial owners of Cardiome Shares, together with their addresses and respective holdings of Cardiome Shares. Cardiome shall from time to time furnish Cipher with such additional information, including updated or additional lists of Cardiome Shareholders and lists of holders of Cardiome Options, Cardiome Warrants, PSUs or RSUs, and such other assistance as Cipher may reasonably request.

 

2.13 U.S. Securities Law Matters

 

The Parties agree that the Arrangement will be carried out with the intention that all Consideration Shares and Correvio Replacement Options issued pursuant to the Arrangement will be issued by Correvio in reliance on the exemption from the registration requirements of the U.S. Securities Act provided by Section 3(a)(10) thereunder. In order to ensure the availability of the exemption under Section 3(a)(10) of the U.S. Securities Act, the Parties agree that the Arrangement will be carried out on the following basis:

 

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(a) the Arrangement will be subject to the approval of the Court;

 

(b) the Court will be advised as to the intention of the Parties to rely on the exemption under Section 3(a)(10) of the U.S. Securities Act prior to the hearing required to approve the Arrangement;

 

(c) the Court will be required to satisfy itself as to the procedural and substantive fairness of the terms and conditions of the Arrangement to the Cardiome Shareholders and holders of Cardiome Options;

 

(d) Cardiome will ensure that each Person entitled to receive Consideration Shares and Correvio Replacement Options on completion of the Arrangement will be given adequate notice advising them of their right to attend the hearing of the Court to give approval of the Arrangement and providing them with sufficient information necessary for them to exercise that right;

 

(e) each Person entitled to receive Consideration Shares or Correvio Replacement Options will be advised that the Consideration Shares and Correvio Replacement Options issued pursuant to the Arrangement have not been registered under the U.S. Securities Act and will be issued by Correvio in reliance on the exemption under Section 3(a)(10) of the U.S. Securities Act;

 

(f) the Final Order approving the Arrangement that is obtained from the Court will state that the Arrangement is approved by the Court as being substantively and procedurally fair to the Cardiome Shareholders and the holders of Cardiome Options; and

 

(g) the Interim Order approving the Cardiome Meeting will specify that each Cardiome Shareholder and each other holder of Cardiome Options will have the right to appear before the Court at the hearing of the Court to give approval of the Arrangement so long as they enter an appearance within a reasonable time.

 

2.14 United States Tax Matters

 

The Parties agree that (a) the exchange is intended to qualify as a reorganization within the meaning of 368(a)(1)(B) of the U.S. Internal Revenue Code (the “ U.S. Tax Code ”); (b) the Plan of Arrangement is intended to be a “plan of reorganization” within the meaning of the Treasury Regulations promulgated under Section 368 of the U.S. Tax Code for purposes of Sections 354 and 361 of the U.S. Tax Code and (c) the reorganization is intended to qualify as a nonrecognition transaction for purposes of the U.S. Tax Code.

 

2.15 Canadian Income Tax Matters

 

(a) Section 85.1 .  It is intended that pursuant to the Arrangement each outstanding Cardiome Share will be exchanged for Consideration Shares and no other consideration such that the share exchange qualifies under Section 85.1 of the Tax Act.

 

(b) Subsection 85(1) Tax Election . Cardiome shall, and Correvio shall cause Correvio Canada to, elect jointly in the prescribed form under subsection 85(1) of the Tax Act within the time period permitted under the Tax Act and under any other applicable provincial or territorial statute at an elected amount that results in the transfer of the Brinavess Assets from Cardiome to Correvio Canada in exchange for the issuance of 100 common shares in the capital of Correvio Canada to Cardiome under the Plan of Arrangement taking place on a tax-free basis. Cardiome shall file such election within the time period prescribed under subsection 85(6) of under the Tax Act.

 

(c) Section 22 Tax Election . If available, Correvio and Cardiome shall elect jointly in the prescribed form under section 22 of the Tax Act and the corresponding provisions of any other applicable Tax statute as to the sale of any receivables from Cardiome to Correvio and designate in such election an amount equal to the fair market value of such receivables. This election, or these elections, shall be made within the time prescribed for such elections.

 

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(d) Subsection 20(24) Tax Election . Correvio and Cardiome shall, if applicable, jointly execute and file an election under subsection 20(24) of the Tax Act in the manner required by subsection 20(25) of the Tax Act and under the equivalent or corresponding provisions of any other applicable provincial or territorial statute, in the prescribed forms and within the time period permitted under the Tax Act and under any other applicable provincial or territorial statute, as to such amount paid by Cardiome to Correvio for assuming future obligations. In this regard, Correvio and Cardiome acknowledge that a portion of the assets of Cardiome transferred by Cardiome to Correvio pursuant to the Arrangement and having a value equal to the amount elected under subsection 20(24) of the Tax Act and the equivalent provisions of any applicable provincial or territorial statute, is being transferred by Cardiome as a payment for the assumption of such future obligations by Correvio.

 

(e) Other Tax Elections . Correvio and Cardiome shall also execute and deliver such other Tax elections and forms as they may mutually agree upon.

 

(f) GST and PST . T o the extent that a transfer of assets from Cardiome to Correvio or from Cardiome to Correvio Canada, as the case may be, is subject to GST under the Excise Tax Act (Canada) or provincial sales tax (“ PST ”) under the Provincial Sales Tax Act (British Columbia), or both, Cardiome shall collect on or before the Effective Time from Correvio or Correvio Canada, or from both, as the case may be, and remit to the appropriate Government Entity the appropriate amount of GST or PST, or both.

 

(g) Purchase Exemption Certificates . Correvio shall provide Cardiome with properly completed purchase exemption certificates, or their equivalent, where applicable, to support any reasonable exemption claimed by Correvio in respect of provincial sales tax.

 

(h) Payment of Taxes . Except as otherwise may be provided in this Agreement, Correvio, or Correvio Canada as the case may be, shall pay all Taxes applicable to, or resulting from the transactions contemplated by, this Agreement (other than Taxes payable by Cardiome under applicable Law as arising as of and after the Effective Time) and any filing, registration, recording or transfer fees payable in connection with the instruments of transfer provided for in this Agreement.

 

2.16 Incentive Plan Matters

 

(a) Each Cardiome Option outstanding immediately prior to the Effective Time shall be exchanged for an option (each, a “ Correvio Replacement Option ”) to purchase from Correvio, without further act or formality, the number of Correvio Shares equal to the product of (A) the number of Cardiome Shares subject to the Cardiome Option immediately before the Effective Time, and (B) the Exchange Ratio, provided that if the foregoing would result in the issuance of a fraction of a Correvio Share on any particular exercise of Correvio Replacement Options, then the number of Correvio Shares otherwise issued shall be rounded down to the nearest whole number of Correvio Shares. The exercise price per Correvio Share subject to any such Correvio Replacement Option shall be an amount equal to the quotient of (A) the exercise price per Cardiome Share under the exchanged Cardiome Option immediately prior to the Effective Time divided by (B) the Exchange Ratio (provided that the aggregate exercise price payable on any particular exercise of Correvio Replacement Options shall be rounded up to the nearest whole cent). Except as set out above, all terms and conditions of a Correvio Replacement Option, including the term to expiry, conditions to and manner of exercising, will be the same as the Cardiome Option for which it was exchanged, and shall be governed by the terms of the Correvio Option Plan and any document evidencing a Cardiome Option shall thereafter evidence and be deemed to evidence such Correvio Replacement Option. If the exchange contemplated by this paragraph results in a disposition of Cardiome Options, it is intended that the provisions of subsection 7(1.4) of the Tax Act apply to any such disposition. Accordingly, and notwithstanding the foregoing, if required, the exercise price of a Correvio Replacement Option will be increased such that the In-The-Money Amount (as defined in the Plan of Arrangement) of the Correvio Replacement Option immediately after the exchange does not exceed the In-The-Money Amount of the Cardiome Option immediately before the exchange.

 

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(b) Immediately following the issuance of the Correvio Replacement Options pursuant to the Plan of Arrangement, the Cardiome Option Plan shall be terminated. Following the Effective Time, Cardiome shall have no further Liability with respect to the Cardiome Option Plan or any Cardiome Options (or any Liability to any former holder thereof).

 

(c) Each Cardiome Warrant shall be adjusted in accordance with the adjustment provisions in the relevant warrant certificate or warrant indenture and Correvio covenants and agrees to be bound by the terms of such warrant certificate or warrant indenture. Following the Effective Time, Cardiome shall have no further Liability with respect to any Cardiome Warrants (or any Liability to any holder or former holder thereof).

 

(d) Each RSU outstanding immediately prior to the Effective Time (whether vested or unvested), notwithstanding the terms of the RSU Plan, shall be deemed to be unconditionally vested, and such RSU shall, without any further action by or on behalf of a holder of RSUs, be deemed to be assigned and transferred by such holder to Cardiome in exchange for a cash payment from Cardiome equal to the fair market value of each RSU on the trading day two days prior to the Effective Date, subject to applicable withholdings, and each such RSU shall immediately be cancelled. Following the Effective Time, Cardiome shall have no further Liability with respect to any Cardiome RSUs (or any Liability to any holder or former holder thereof).

 

(e) Each PSU outstanding immediately prior to the Effective Time (whether vested or unvested), notwithstanding the terms of the PSU Plan, shall be deemed to be unconditionally vested, and such PSU shall, without any further action by or on behalf of a holder of PSUs, be deemed to be assigned and transferred by such holder to Cardiome in exchange for a cash payment from Cardiome equal to the fair market value of each PSU on the trading day two days prior to the Effective Date, subject to applicable withholdings, and each such PSU shall immediately be cancelled. Following the Effective Time, Cardiome shall have no further Liability with respect to any Cardiome PSUs (or any Liability to any holder or former holder thereof).

 

2.17 Reorganization

 

(a) Prior to the Effective Time, Cardiome shall, or shall cause certain subsidiaries (as identified below) to, carry out the following transactions (the “ Pre-Closing Reorganization ”), which Pre-Closing Reorganization is hereby specifically acknowledged and permitted by the Parties to occur on or prior to the Effective Date:

 

(i) Cardiome shall cause Correvio Canada to be incorporated as a wholly owned subsidiary of Cardiome and shall cause Correvio Canada to be registered for the purposes of the Excise Tax Act (Canada);

 

(ii) Cardiome shall assign any and all of its right, title or interest in or to the Moved Trevyent Assets to Correvio International Sarl, in consideration of Correvio International Sarl issuing to Cardiome, a non-interest bearing promissory note with a principal amount equal to the fair market value of Cardiome’s interest in the Moved Trevyent Assets;

 

(iii) Cardiome and Correvio International Sarl shall enter into the Sublicense Agreement (Trevyent) and Sublicense Agreement (Xydalba) as partial repayment of an existing loan from Cardiome to Correvio International Sarl by an amount equal to the aggregate fair market value of the Sublicense Agreement (Trevyent) and Sublicense Agreement (Xydalba); and

 

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(iv) Cardiome International SA, Correvio International Sarl and Cardiome (UK) Ltd., shall assign any and all of their right, title or interest in or to the Moved SARL Plus SA Assets to Cardiome as partial repayment of existing loans from Cardiome to Cardiome International SA, Correvio International Sarl and Cardiome (UK) Ltd. by an amount equal to the aggregate fair market value of the Moved SARL Plus SA Assets transferred by each to Cardiome.

 

(b) After the Effective Time, if the Effective Time is on or prior to June 28, 2018, and in any event prior to June 30, 2018, Cardiome International SA and Correvio International Sarl shall amalgamate and continue as one corporation.

 

(c) Cardiome shall provide to Cipher all documentation reasonably requested by Cipher related to the Pre-Closing Reorganization for its review and comment at least five (5) Business Days prior to the Effective Date.

 

Article 3
REPRESENTATIONS AND WARRANTIES OF CARDIOME AND CORREVIO

 

3.1 Representations and Warranties of Cardiome

 

Cardiome represents and warrants to Cipher as set forth in Schedule C, except to the extent that such representations and warranties are qualified by the Cardiome Disclosure Letter (which shall make reference to the corresponding section or subsection of Schedule C), and acknowledges and agrees that Cipher is relying upon such representations and warranties in connection with the entering into of this Agreement and the completion of the transactions contemplated herein. Any investigation by Cipher or its Representatives shall not mitigate, diminish or affect the representations and warranties of Cardiome pursuant to this Agreement.

 

3.2 Survival of Representations and Warranties of Cardiome

 

The representations and warranties of Cardiome contained in this Agreement shall not survive the completion of the Arrangement and shall expire and be terminated on the earlier of the Effective Time and the date on which this Agreement is terminated in accordance with its terms.

 

3.3 Representations and Warranties of Correvio

 

Correvio represents and warrants to Cipher as set forth in Schedule D, and acknowledges and agrees that Cipher is relying upon such representations and warranties in connection with the entering into of this Agreement and the completion of the transactions contemplated herein. Any investigation by Cipher or its Representatives shall not mitigate, diminish or affect the representations and warranties of Correvio pursuant to this Agreement.

 

3.4 Survival of Representations and Warranties of Correvio

 

The representations and warranties of Correvio contained in this Agreement shall not survive the completion of the Arrangement and shall expire and be terminated on the earlier of the Effective Time and the date on which this Agreement is terminated in accordance with its terms.

 

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Article 4
REPRESENTATIONS AND WARRANTIES OF CIPHER

 

4.1 Representations and Warranties of Cipher

 

Cipher represents and warrants to Cardiome as set forth in Schedule E, and acknowledges and agrees that Cardiome is relying upon such representations and warranties in connection with the entering into of this Agreement and the completion of the transactions contemplated herein. Any investigation by Cardiome or its Representatives shall not mitigate, diminish or affect the representations and warranties of Cipher pursuant to this Agreement.

 

4.2 Survival of Representations and Warranties of Cipher

 

The representations and warranties of Cipher contained in this Agreement shall not survive the completion of the Arrangement and shall expire and be terminated on the earlier of the Effective Time and the date on which this Agreement is terminated in accordance with its terms.

 

Article 5
COVENANTS

 

5.1 Covenants of Cardiome Relating to the Arrangement

 

Cardiome shall perform all obligations required to be performed by Cardiome under this Agreement, co-operate with Cipher in connection therewith, and do all such other acts and things as may be necessary or desirable in order to consummate and make effective, as soon as reasonably practicable, the transactions contemplated in this Agreement and, without limiting the generality of the foregoing, Cardiome shall:

 

(a) apply for and use commercially reasonable efforts to obtain all Key Regulatory Approvals and all Key Third Party Consents, keep Cipher reasonably informed as to the status of the proceedings related to obtaining the Key Regulatory Approvals and Key Third Party Consents, including providing Cipher with copies of all related applications and notifications, in draft form (except where such material is confidential in which case it will be provided (subject to applicable Laws) to Cipher’s outside counsel on an “external counsel” basis), in order for Cipher to provide its comments thereon, which shall be given due and reasonable consideration;

 

(b) use commercially reasonable efforts to satisfy all conditions precedent in this Agreement and take all steps set forth in the Interim Order and Final Order applicable to it and comply promptly with all requirements which applicable Laws may impose on Cardiome with respect to the Arrangement or the other transactions contemplated by this Agreement;

 

(c) use commercially reasonable efforts to obtain, effective as of the Effective Time, releases, in favour of Cardiome, in respect of Liabilities under the Cardiome Material Contracts from the respective counterparties thereto, in each case in form and substance acceptable to the Parties, each acting reasonably;

 

(d) if requested to do so in writing by Cipher on or before the fifth (5 th ) Business Day before the Effective Date, terminate, cancel or withdraw, as applicable, any one or more of the contracts, attestations and statement of works listed in subsections 5(h)(i) to (v) of Schedule F;

 

(e) defend all lawsuits or other legal, regulatory or other proceedings against Cardiome challenging or affecting this Agreement or the consummation of the transactions contemplated hereby and use commercially reasonable efforts to have lifted or rescinded any injunction or restraining order or other order relating to Cardiome which may materially impede the ability of the Parties to consummate the Arrangement or the other transactions contemplated by this Agreement;

 

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(f) not take any action that is intended to, or would reasonably be expected to, individually or in the aggregate, prevent, materially delay or materially impede the ability of Cardiome to consummate the Arrangement or the other transactions contemplated by this Agreement;

 

(g) prior to the Effective Time, terminate without any Liability to Cardiome all Inter-company Agreements, except for those Inter-company Agreements that constitute Retained Assets or Retained Liabilities (as listed in Schedules F and G, respectively);

 

(h) until the earlier of the Effective Time and termination of this Agreement in accordance with its terms, subject to applicable Law, make available and cause to be made available to Cipher, and its Representatives, information reasonably requested by Cipher for the purposes of preparing, considering and implementing integration and strategic plans for the acquisition by Cipher of the Retained Assets and Retained Liabilities following the Effective Date and confirming the representations and warranties of Cardiome set out in this Agreement, except as provided for in any sublicense or transition and supply agreements entered into by the Parties regarding the Retained Assets and Retained Liabilities (and in which case the terms of such agreements shall govern the conduct of the Parties); and

 

(i) until the earlier of the Effective Time and termination of this Agreement in accordance with its terms, Cardiome shall, to the extent not precluded by applicable Law, promptly notify Cipher, in writing, when Cardiome has knowledge of:

 

(i) any Material Adverse Effect or any change, effect, event, development, occurrence, circumstance or state of facts which would reasonably be expected to have a Material Adverse Effect;

 

(ii) any notice or other communication from any Person alleging that the consent (or waiver, permit, exemption, order, approval, agreement, amendment or confirmation) of such Person (or other Person) is or may be required in connection with this Agreement or the Arrangement;

 

(iii) any notice or other communication from any Governmental Entity in connection with the Arrangement or this Agreement (and contemporaneously provide a copy of any such written notice or communication to Cipher); or

 

(iv) any filing, actions, suits, claims, investigations or proceedings commenced or, to the knowledge of Cardiome, threatened orally or in writing against, relating to or involving or otherwise affecting Cardiome, its subsidiaries or any of their respective assets that would reasonably be expected to have a Material Adverse Effect.

 

5.2 Covenants of Cardiome Relating to the Conduct of Business

 

Cardiome covenants and agrees that at all times prior to the Effective Time, except as disclosed in the Cardiome Disclosure Letter or as otherwise expressly contemplated or permitted by this Agreement (including, the Pre-Closing Reorganization permitted under Section 2.17 of this Agreement), or as Cipher shall otherwise agree in writing, Cardiome shall, and shall cause its subsidiaries (as applicable) to:

 

(a) conduct its businesses and affairs related to the Retained Assets and Retained Liabilities in, and not take any action related to the Retained Assets and Retained Liabilities except in, the ordinary course of business consistent with past practice;

 

(b) use commercially reasonable efforts to maintain and preserve all of its material rights under each Contract or Authorization related to any Retained Asset or Retained Liability;

 

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(c) pay, discharge or satisfy, in the ordinary course of business consistent with past practice, Liabilities reflected or reserved against in the Cardiome Financial Statements or incurred in the ordinary course of business consistent with past practice, and not incur any new Liability outside the ordinary course of business;

 

(d) without limiting the foregoing, pay, discharge or satisfy the Retained Liabilities in the ordinary course of business consistent with past practice;

 

(e) use commercially reasonable efforts to preserve intact its present business organization, the Retained Assets and Retained Liabilities (including associated intellectual property) and goodwill related to the Retained Assets, and preserve the current material relationships with suppliers, distributors, employees, consultants, customers and others having business relationships with it related to the Retained Assets and Retained Liabilities;

 

(f) continue to employ the Retained Employees on their current terms and conditions;

 

(g) not:

 

(i) amend or propose to amend the articles or by-laws or other constating documents of Cardiome;

 

(ii) except as contemplated by this Agreement, split, consolidate or reclassify, or propose to split, consolidate or reclassify, any of the Cardiome Shares or undertake or propose to undertake any other capital reorganization or change in the Cardiome Shares or any other securities of Cardiome;

 

(iii) amend the terms of any outstanding equity securities of Cardiome;

 

(iv) declare, set aside or pay any dividend or other distribution or payment (whether in cash, securities or property or any combination thereof) in respect of the Cardiome Shares or any other securities of Cardiome,

 

(v) redeem, purchase or otherwise acquire, or offer to redeem, purchase or otherwise acquire, any Cardiome Shares or any other securities of Cardiome;

 

(vi) adopt a plan of liquidation or resolution providing for the liquidation or dissolution of Cardiome;

 

(vii) acquire or agree to acquire (by merger, amalgamation, acquisition of shares or assets or otherwise) any company, partnership or other business organization or division, or incorporate or form, or agree to incorporate or form, any company, partnership or other business organization or make or agree to make any investment either by purchase of shares or securities, contributions of capital, property transfer or purchase of, any property or assets of any other Person, company, partnership or other business organization;

 

(viii) except as contemplated by this Agreement, pursue any corporate acquisition, merger or make any other material change to its business or affairs;

 

(ix) enter into or agree to the terms of any joint venture or similar agreement, arrangement or relationship;

 

(x) sell, pledge, lease, dispose of or encumber any of the Retained Assets or Retained Liabilities, except in the ordinary course of business consistent with past practice;

 

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(xi) waive, release, grant or transfer any rights in respect of, or modify or change in any material respect, any Retained Asset or Retained Liability, without first advising Cipher and obtaining Cipher’s consent and direction, acting reasonably, as to any action to be taken in that regard, and forthwith taking any action directed by Cipher, acting reasonably;

 

(xii) take any action or fail to take any action which action or failure to act would result in the loss, expiration or surrender of, or the loss of any material benefit under, or reasonably be expected to cause any Governmental Entities to institute proceedings for the suspension, revocation or limitation of rights under, any material Authorizations relating to any Retained Asset or Retained Liability; or fail to prosecute with commercially reasonable due diligence any pending applications to any Governmental Entities relating to any Retained Asset or Retained Liability;

 

(xiii) waive, release, transfer, modify or amend, in any material respect, any Contract or Authorization related to any Retained Asset or Retained Liability;

 

(xiv) enter into or adopt any shareholder rights plan or similar agreement or arrangement;

 

(xv) make any changes to existing accounting policies, other than as required by applicable Laws or by U.S. GAAP;

 

(xvi) change any method of Tax accounting, make or change any Tax election, file any materially amended Tax Returns, settle or compromise any Tax liability, agree to an extension or waiver of the limitation period with respect to the assessment, reassessment, or determination of Taxes, enter into any closing agreement with respect to any Tax or surrender any right to claim a material Tax refund;

 

(xvii) take any action that would reasonably be expected to interfere with or be inconsistent with the completion of the Arrangement or the transactions contemplated in this Agreement; or

 

(xviii) announce an intention, enter into any formal or informal agreement, or otherwise make a commitment to do any of the things prohibited by any of the foregoing subsections.

 

(h) Subject to Section 7.5, Cardiome shall use commercially reasonable efforts to cause its current insurance (or re-insurance) policies not to be cancelled or terminated or any of the coverage thereunder to lapse before the Outside Date, unless simultaneously with such termination, cancellation or lapse, replacement policies underwritten by insurance and re-insurance companies of nationally recognized standing providing coverage equal to or greater than the coverage under the cancelled, terminated or lapsed policies for substantially similar premiums are in full force and effect.

 

(i) (i) Duly and timely file all Tax Returns required to be filed by it on or after the date hereof and all such Tax Returns will be true, complete and correct in all material respects; (ii) timely withhold, collect, remit and pay all Taxes which are to be withheld, collected, remitted or paid by it to the extent due and payable, except for any Taxes contested in good faith pursuant to applicable Laws or that are immaterial in amount (either individually or in the aggregate); (iii) not make or rescind any material express or deemed election relating to Taxes except as required or desirable in respect of the Arrangement; (iv) not make a request for a tax ruling or enter into a closing agreement with any taxing authorities; (v) not settle or compromise any material claim, action, suit, litigation, proceeding, arbitration, investigation, audit or controversy relating to Taxes; and (vi) not change in any material respect any of its methods of reporting income, deductions or accounting for income tax purposes from those employed in the preparation of its income Tax Return for the tax year ending December 31, 2016, except as may be required by applicable Laws.

 

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5.3 Transferred Employees

 

Cardiome shall terminate the employment of all employees of Cardiome (other than the Retained Employees) as of the Effective Time and Correvio shall either offer employment to all such employees of Cardiome, with effect from and after the Effective Time, on terms that are substantially the same as the terms applicable to such employees when they were employees of Cardiome or make arrangements for the payment of termination pay or severance to such employees, such payment obligations to be assumed by and be solely the responsibility of Correvio. From and after the Effective Date, Correvio shall assume and be responsible for all obligations with respect to the engagement or employment of all employees (other than Retained Employees) and directors of Cardiome engaged or employed by Cardiome prior to and as of the Effective Time, including with respect to all notice of termination and severance pay in accordance with applicable Law (including employment standards) and Contract, if applicable, obligations under Employee Plans and for all unpaid wages, accrued vacation pay, change of control, and other amounts owing to employees or directors of Cardiome up to and as of the Effective Time (whether payable before or after the Effective Time), and for all Claims of any nature or kind relating to employment or engagement by Cardiome up to the Effective Time, including for breach of contract or wrongful dismissal. Cardiome shall retain liability and be responsible for any amounts payable to all Retained Employees on account of their employment with Cardiome or the termination of that employment that accrue or become payable after the Effective Date. The obligations contained in this Section 5.3 (the “ Employee Obligations ”) shall survive the execution and delivery of this Agreement and the completion of the transactions contemplated by this Agreement, including the Arrangement.

 

5.4 Post-Closing Filings

 

Following the Effective Time, the Parties shall co-operate with each other in respect of any filings to be made with Securities Authorities pursuant to applicable Securities Laws or Governmental Entities arising in connection with, or resulting from, the Arrangement and other transactions contemplated by this Agreement. Without limiting the foregoing, if Cipher is obliged to file a business acquisition report (“ Business Acquisition Report ”) with Canadian Securities Authorities in respect of the Arrangement, pursuant to National Instrument 51-102 Continuous Disclosure Obligations (“ NI 51-102 ”), Correvio shall provide all such assistance (at the cost and expense of Cipher) as is reasonably necessary to prepare all such financial statements (including carve-out statements) as may required to be included in the Business Acquisition Report, within the applicable time period prescribed by NI 51-102.

 

Article 6
CONDITIONS

 

6.1 Mutual Conditions Precedent

 

The obligations of the Parties to complete the Arrangement are subject to the fulfillment of each of the following conditions precedent on or before the Effective Time, each of which may only be waived with the mutual written consent of the Parties without prejudice to their right to rely on any other of such conditions:

 

(a) the Interim Order having been granted on terms consistent with this Agreement and the Interim Order not having been set aside or modified in a manner unacceptable to any Party, acting reasonably, on appeal or otherwise;

 

(b) the Cardiome Arrangement Resolution having been passed by the Cardiome Shareholders in accordance with the Interim Order;

 

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(c) the Final Order having been granted on terms consistent with this Agreement and the Final Order not having been set aside or modified in a manner unacceptable to any Party, acting reasonably, on appeal or otherwise;

 

(d) there shall have been no action taken under any applicable Law or by any Governmental Entity which make it illegal or otherwise directly or indirectly restrains, enjoins or prohibits the completion of the Arrangement;

 

(e) the Key Regulatory Approvals shall have been obtained;

 

(f) the Key Third Party Consents shall have been obtained;

 

(g) the Transfer Agreement and all other documentation reasonably necessary for, or otherwise relating to, the sale, conveyance, grant, transfer and assignment of the Assigned Assets to Correvio shall be in form and substance acceptable to each Party, acting reasonably;

 

(h) the Assignment and Assumption Agreement and all other documentation reasonably necessary for, or otherwise relating, the assumption of the Assumed Liabilities by Correvio shall be in form and substance acceptable to each Party, acting reasonably;

 

(i) a release in favour of Cardiome in respect of Liabilities under the CRG Loan, in form and substance acceptable to the Parties, each acting reasonably, shall have been obtained from the counterparties thereto;

 

(j) a release in favour of Cardiome in respect of Liabilities under the Office Lease, in form and substance acceptable to the Parties, each acting reasonably, shall have been obtained from the counterparties thereto, or, alternatively, a valid notice of termination of the Office Lease, in form and substance acceptable to the Parties, each acting reasonably, shall have been delivered to the counterparties thereto;

 

(k) a release in favour of Cardiome in respect of Liabilities under the obligations of Cardiome as a guarantor referenced in Schedule C(p) of the Disclosure Letter, in form and substance acceptable to the Parties, each acting reasonably, shall have been obtained from the counterparties thereto;

 

(l) the Articles of Arrangement to be filed with the Director in accordance with this Agreement shall be in form and substance acceptable to the Parties, each acting reasonably;

 

(m) the distribution of the Consideration Shares pursuant to the Arrangement shall be exempt from the prospectus and registration requirements of applicable Canadian securities laws either by virtue of exemptive relief from the securities regulatory authorities of each of the provinces of Canada or by virtue of applicable exemptions under Canadian securities laws and shall not be subject to resale restrictions under applicable Canadian securities laws (other than as applicable to control persons or pursuant to section 2.6 of National Instrument 45-102);

 

(n) the Consideration Shares and Correvio Replacement Options shall be exempt from the registration requirements of the U.S. Securities Act pursuant to Section 3(a)(10) thereof based on the Court’s approval of the Arrangement; provided however, that Cardiome shall not be entitled to rely on the provisions of this Subsection 6.1(l) in failing to complete the transactions contemplated by this Agreement in the event that Cardiome fails to advise the Court prior to the hearing in respect of the Final Order, as required by the terms of the foregoing exemptions, that Correvio will rely on the foregoing exemption based on the Court’s approval of the Arrangement, and

 

(o) this Agreement shall not have been terminated in accordance with its terms.

 

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6.2 Additional Conditions Precedent in Favour of Cipher

 

The obligation of Cipher to complete the Arrangement is subject to the fulfillment of each of the following additional conditions precedent on or before the Effective Time (each of which is for the exclusive benefit of Cipher and may be only waived by Cipher):

 

(a) all covenants of Cardiome and Correvio under this Agreement to be performed on or before the Effective Time which have not been waived by Cipher shall have been duly performed by Cardiome and Correvio in all material respects and Cipher shall have received a certificate of each of Cardiome and Correvio addressed to Cipher and dated the Effective Date, signed on behalf of each of Cardiome and Correvio by two of its senior executive officers (without personal liability), confirming the same as of the Effective Date;

 

(b) the representations and warranties of Cardiome and Correvio set forth in this Agreement shall be true and correct in all respects, without regard to any materiality or Material Adverse Effect qualifications contained in them as of the Effective Time, as though made on and as of the Effective Time (except for representations and warranties made as of a specified date, the accuracy of which shall be determined as of that specified date), except where the failure or failures of all such representations and warranties to be so true and correct in all respects would not reasonably be expected to have a Material Adverse Effect, provided however that it is understood and agreed that the representations and warranties set out in paragraphs (a), (d), (f), (g), (i), (r) and (ee) of Schedule C and (a), (d), (e) and (g) of Schedule D must be true and correct in all respects when made on and as of the Effective Time, and Cipher shall have received a certificate of each of Cardiome and Correvio addressed to Cipher and dated the Effective Date, signed on behalf of each of Cardiome and Correvio by two of its senior executive officers (without personal liability), confirming the same as at the Effective Date;

 

(c) the Sublicense Agreement (Trevyent) shall have been entered into with effect prior to or as of the Effective Time;

 

(d) the Sublicense Agreement (Xydalba) shall have been entered into with effect prior to or as of the Effective Time;

 

(e) the Ancillary Agreements (Aggrastat), in form and substance acceptable to Cipher, acting reasonably, shall have been entered into with effect prior to or as of the Effective Time;

 

(f) the Ancillary Agreements (Brinavess), in form and substance acceptable to Cipher, acting reasonably, shall have been entered into with effect prior to or as of the Effective Time;

 

(g) any Retained Assets, to the extent not held by Cardiome as of the date hereof, will be transferred or assigned to Cardiome, to the satisfaction of Cipher, acting reasonably, with effect prior to or as of the Effective Time;

 

(h) there shall not have occurred a Material Adverse Effect that has not been publicly disclosed by Cardiome prior to the date hereof, and since the date of this Agreement, there shall not have occurred a Material Adverse Effect, and Cipher shall have received a certificate of Cardiome addressed to Cipher and dated the Effective Date, signed on behalf of Cardiome by two of its senior executive officers (without personal liability), confirming the same as at the Effective Date;

 

(i) there shall be no suit, action or proceeding by any Governmental Entity or any other Person that has resulted in an imposition of material limitations on the ability of Cipher to acquire or hold, or exercise full rights of ownership of, any Cardiome Shares; and

 

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(j) Cipher shall have received all of the Cardiome Voting Agreements executed by the Cardiome Supporting Shareholders and all covenants of the Cardiome Supporting Shareholders under the Cardiome Voting Agreements to be performed on or before the Effective Time which have not been waived by Cipher shall have been duly performed by the parties thereto (other than Cipher) in all material respects.

 

The foregoing conditions will be for the sole benefit of Cipher and may be waived by it in whole or in part at any time.

 

6.3 Additional Conditions Precedent in Favour of Cardiome

 

The obligation of Cardiome to complete the Arrangement is subject to the fulfillment of each of the following additional conditions precedent on or before the Effective Time (each of which is for the exclusive benefit of Cardiome and may be waived only by Cardiome):

 

(a) all covenants of Cipher under this Agreement to be performed on or before the Effective Time which have not been waived by Cardiome shall have been duly performed by Cipher in all material respects and Cardiome shall have received a certificate of Cipher addressed to Cardiome and dated the Effective Date, signed on behalf of Cipher by two of its senior executive officers (without personal liability), confirming the same as of the Effective Date;

 

(b) the representations and warranties of Cipher set forth in this Agreement shall be true and correct in all respects, without regard to any materiality or material adverse effect qualifications contained in them as of the Effective Time, as though made on and as of the Effective Time (except for representations and warranties made as of a specified date, the accuracy of which shall be determined as of that specified date), except where the failure or failures of all such representations and warranties to be so true and correct in all respects would not reasonably be expected to have a material adverse effect, and Cardiome shall have received a certificate of Cipher addressed to Cardiome and dated the Effective Date, signed on behalf of Cipher by two senior executive officers of Cipher (without personal liability), confirming the same as at the Effective Date;

 

(c) Cardiome shall have received satisfactory evidence of the conditional approval for listing of the Consideration Shares from the TSX and Nasdaq, subject only to customary listing conditions of the TSX and Nasdaq;

 

(d) Cipher shall have made arrangements satisfactory to Correvio, acting reasonably, to pay the aggregate Share Purchase Consideration (less the Holdback Amount) to Correvio, in immediately available funds, on the Effective Date pursuant to the Arrangement; and

 

(e) holders of no more than five percent (5%) of the Cardiome Shares shall have exercised, and at the date of the Cardiome Meeting, have not withdrawn, Dissent Rights.

 

The foregoing conditions will be for the sole benefit of Cardiome and may be waived by it in whole or in part at any time.

 

6.4 Notice and Cure Provisions

 

(a) Each Party will give prompt notice to the other of the occurrence, or failure to occur, at any time from the date hereof until the earlier to occur of the termination of this Agreement and the Effective Time, of any event or state of facts which occurrence or failure would, or would be likely to:

 

(i) cause any of the representations or warranties of any Party contained herein to be untrue or inaccurate in any material respect on the date hereof or at the Effective Time; or

 

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(ii) result in the failure to comply with or satisfy any covenant, condition or agreement to be complied with or satisfied by any Party hereunder prior to the Effective Time.

 

(b) Cipher may not exercise its rights to terminate this Agreement pursuant to Subsection 8.2(a)(iii)C and Cardiome may not exercise its right to terminate this Agreement pursuant to Subsection 8.2(a)(iv)A unless the Party intending to rely thereon has delivered a written notice to the other Party specifying in reasonable detail all breaches of covenants, representations and warranties or other matters which the Party delivering such notice is asserting as the basis for the non-fulfilment or the applicable condition or termination right, as the case may be. If any such notice is delivered, provided that a Party is proceeding diligently to cure such matter and such matter is capable of being cured, no Party may terminate this Agreement until the expiration of a period of three (3) Business Days from such notice, and then only if such matter has not been cured by such date. If such notice has been delivered prior to the making of the application for the Final Order, such application and such filing shall be postponed until the expiry of such period. For greater certainty, in the event that such matter is cured within the time period referred to herein without a Material Adverse Effect, this Agreement may not be terminated as a result of the cured breach.

 

6.5 Satisfaction of Conditions

 

Other than as set forth in this section, the conditions precedent set out in Section 6.1, Section 6.2 and Section 6.3 shall be conclusively deemed to have been satisfied, waived or released when the Certificate of Arrangement is issued by the Director following filing of the Articles of Arrangement with the consent of the Parties in accordance with the terms of this Agreement.

 

Article 7
ADDITIONAL COVENANTS

 

7.1 Covenant Regarding Non-Solicitation

 

Cardiome shall, and shall direct and cause its Representatives to, immediately cease and cause to be terminated any solicitation, encouragement, activity, discussion or negotiation with any parties that may be ongoing with respect to an Acquisition Proposal whether or not initiated by Cardiome, and Cardiome shall request the return of information regarding Cardiome and its subsidiaries previously provided to such parties and shall request the destruction of all materials including or incorporating any confidential information regarding Cardiome and its subsidiaries. Cardiome agrees not to release any third party from any confidentiality agreement relating to a potential Acquisition Proposal to which such third party is a party. Cardiome further agrees not to release any third party from any standstill or similar agreement or obligation to which such third party is a party or by which such third party is bound (it being understood and agreed that the automatic termination of a standstill provision due to the announcement of the Arrangement or the entry into this Agreement shall not be a violation of this Section 7.1).

 

7.2 Covenant Regarding Acquisition Proposal

 

(a) Subject to Section 7.3 or unless expressly permitted pursuant to this Section 7.2, Cardiome agrees that it shall not, and shall not authorize or permit any of its Representatives, directly or indirectly, to:

 

(i) make, solicit, initiate, entertain, encourage, promote or facilitate, (including by way of furnishing information, permitting any visit to its facilities or properties or entering into any form of agreement, arrangement or understanding) any inquiries or the making of any proposals regarding an Acquisition Proposal or that may be reasonably be expected to lead to an Acquisition Proposal;

 

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(ii) participate, directly or indirectly, in any discussions or negotiations regarding, or furnish to any Person any information or otherwise co-operate with, respond to, assist or participate in any Acquisition Proposal or potential Acquisition Proposal, provided however that Cardiome may communicate and participate in discussions with a third party for the purpose of (A) clarifying the terms of any proposal in order to determine if it may reasonably be expected to lead to a Superior Proposal; and (B) advising such third party that an Acquisition Proposal does not constitute a Superior Proposal and cannot reasonably be expected to result in a Superior Proposal;

 

(iii) remain neutral with respect to, or agree to, approve or recommend any, Acquisition Proposal or potential Acquisition Proposal (it being understood that publicly taking no position or a neutral position with respect to an Acquisition Proposal until five (5) Business Days following formal announcement of such Acquisition Proposal shall not be considered to be a violation of this Subsection 7.2(a)(iii);

 

(iv) withdraw, modify, qualify or change in a manner adverse to Cipher, or publicly propose to or publicly state that it intends to withdraw, modify, qualify or change in a manner adverse to Cipher, the approval, recommendation or declaration of advisability of its Board or any committee thereof of this Agreement or the Arrangement (a “ Change in Recommendation ”) (it being understood that failing to affirm the approval or recommendation of its Board of this Agreement or the Arrangement within five (5) Business Days after an Acquisition Proposal has been publicly announced shall be considered to be an adverse modification);

 

(v) enter into any agreement, arrangement or understanding related to any Acquisition Proposal or requiring it to abandon, terminate or fail to consummate the Arrangement or providing for the payment of any break, termination or other fees or expenses to any Person in the event that the Arrangement is completed or in the event that it completes any other transaction with Cipher or with an affiliate of Cipher that is agreed to prior to any termination of this Agreement; or

 

(vi) make any public announcement or take any other action inconsistent with the recommendation of its Board to approve the Arrangement.

 

(b) Notwithstanding anything contained in this Section 7.2 and any other provisions of this Agreement:

 

(i) the Cardiome Board may consider, participate in any discussions or negotiations with and provide information to, any Person who has delivered a written Acquisition Proposal which was not solicited or encouraged by Cardiome after the date of this Agreement and did not otherwise result from a breach of this Section 7.2 and that the Cardiome Board determines in good faith after consultation with its financial advisor and outside legal counsel that such Acquisition Proposal may reasonably be expected to lead to a Superior Proposal; provided, however, that prior to taking any such action the Cardiome Board determines in good faith, after consultation with outside counsel that it is necessary to take such action in order to discharge properly its fiduciary duties, and if Cardiome provides confidential non-public information to such Person, Cardiome obtains a confidentiality and standstill agreement from the Person making such Acquisition Proposal that is substantively the same as the Confidentiality Agreement, and otherwise on terms no more favourable to such Person than the Confidentiality Agreement, including a standstill provision at least as stringent as contained in the Confidentiality Agreement (provided that, such confidentiality agreement shall not preclude such Person from making a Superior Proposal and such agreement shall not restrict or prohibit Cardiome from disclosing to Cipher any details concerning the Acquisition Proposal or any Superior Proposal made by such Person). Cardiome shall be permitted to provide such Person with access to information regarding Cardiome and its subsidiaries; provided that Cardiome sends a copy of any such confidentiality agreement to Cipher promptly upon its execution and Cipher is provided with a list of the information provided to such Person and is promptly provided with access to the same information to which such Person was provided.

 

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(ii) Nothing in this Agreement shall prohibit the Cardiome Board from making a Change in Recommendation or from making any disclosure to any of its securityholders prior to the Effective Time if, in the good faith judgment of such Board, after consultation with outside legal counsel, failure to take such action or make such disclosure would be inconsistent with the exercise of its fiduciary duties or such action or disclosure is otherwise required under applicable Law (including by responding to an Acquisition Proposal under a directors’ circular or otherwise as required under applicable Securities Laws); provided that, no Change in Recommendation may be made in relation to an Acquisition Proposal unless Cardiome complies with Section 7.3.

 

(c) Cardiome shall promptly (and in any event within 24 hours) notify Cipher, at first orally and then in writing, of any proposals, offers or written inquiries relating to or constituting an Acquisition Proposal or any request for non-public information relating to Cardiome or any of its subsidiaries. Such notice shall include a description of the terms and conditions of any proposal, inquiry or offer, the identity of the Person making such proposal, inquiry or offer and provide such other details of the proposal, inquiry or offer as Cipher may reasonably request. Cardiome shall keep Cipher fully informed on a prompt basis of the status, including any change to the material terms, of any such proposal, inquiry or offer.

 

(d) Cardiome shall ensure that its officers, directors and any financial advisors or other advisors or Representatives retained by it are aware of the provisions of this Section 7.2, and it shall be responsible for any breach of this Section 7.2 by such officers, directors, financial advisors or other advisors or Representatives.

 

7.3 Right to Accept a Superior Proposal

 

(a) If Cardiome has complied with Section 7.2 of this Agreement, Cardiome may accept, approve, recommend or enter into any agreement, understanding or arrangement in respect of a Superior Proposal (other than a confidentiality agreement, the execution of which shall not be subject to the conditions of this Section 7.3) received prior to the date of approval of the Arrangement and the transactions contemplated by this Agreement by Cardiome’s Shareholders and terminate this Agreement if, and only if:

 

(i) Cardiome has provided Cipher with a copy of the Superior Proposal document;

 

(ii) Cardiome has provided the other Party with the information regarding such Superior Proposal required under Subsection 7.2(c);

 

(iii) the Cardiome Board has determined in good faith, after consultation with outside legal counsel and its financial advisors, that it is necessary in order for the Cardiome Board to discharge properly its fiduciary duties to withdraw or modify its approval or recommendation of this Agreement and to approve or recommend such Superior Proposal; and

 

(iv) five (5) Business Days (the “ Superior Proposal Notice Period ”) shall have elapsed from the later of (A) the date Cipher received written notice (a " Superior Proposal Notice ") advising it that the Cardiome has resolved to accept, approve, recommend or enter into an agreement in respect of such Superior Proposal, subject only to this Section 7.3, and (B) the date that Cipher received a copy of such Superior Proposal document.

 

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In the event that Cardiome provides Cipher with a Superior Proposal Notice on a date that is less than seven (7) Business Days prior to the scheduled date of the Cardiome Meeting, Cardiome shall, at the request of Cipher, adjourn such meeting to a date that is not less than five (5) Business Days and not more than fifteen (15) days after the date of the Superior Proposal Notice. If the Cardiome Circular has been sent to Cardiome Shareholders prior to the expiry of the Superior Proposal Notice Period and, during such period, Cipher requests in writing that the Cardiome Meeting proceed, unless otherwise ordered by a court, Cardiome shall continue to take all reasonable steps necessary to hold the Cardiome Meeting and to cause the Arrangement and the transactions contemplated by this Agreement to be voted on at such meeting.

 

(b) During the Superior Proposal Notice Period, Cardiome agrees that Cipher shall have the right, but not the obligation, to offer in writing to amend the terms of this Agreement. The Cardiome will review any written proposal to amend the terms of this Agreement in good faith in order to determine, in its discretion in the exercise of its fiduciary duties, whether any such amended proposal would, upon acceptance by Cardiome, result in such Superior Proposal ceasing to be a Superior Proposal. If the Cardiome Board so determines, Cardiome will enter into an amended agreement with Cipher reflecting the amended proposal.

 

(c) Upon the expiry of the Superior Proposal Notice Period, if: (i) Cipher has determined not to offer in writing to amend the terms of this Agreement pursuant to Subsection 7.3(b); or (ii) the Cardiome Board has determined that any offer by Cipher in writing to amend the terms of this Agreement (pursuant to Subsection 7.3(b)) would, upon acceptance by Cardiome, not result in any Superior Proposal ceasing to be a Superior Proposal, then Cardiome may accept, approve, recommend or enter into an agreement, understanding or arrangement in respect of such Superior Proposal, subject to compliance with the Termination Payment provisions in Section 8.4 of this Agreement.

 

(d) Cardiome also acknowledges and agrees that each successive material modification of any Acquisition Proposal shall constitute a new Acquisition Proposal for purposes of the requirement under Subsection 7.3(a)(iv) and will initiate a new and additional Superior Proposal Notice Period.

 

7.4 Access to Information; Confidentiality; Transition

 

From the date hereof until the earlier of the Effective Time and the termination of this Agreement pursuant to its terms, subject to compliance with applicable Law and the terms of any existing Contracts: (a) Cardiome shall, and shall cause its Representatives to, afford to Cipher and to Representatives of Cipher full access during normal business hours upon reasonable notice, to all properties, information and records relating to Cipher, including but not limited to, all related facilities, books, contracts, financial statements, forecasts, financial projections (to the extent permitted by confidentiality agreements in force on the date hereof), studies, records, operating Permits and any other documentation (whether in writing or stored in computerized, electronic, disk, tape, microfilm or any other form) or materials of any kind or nature whatsoever, and Cipher and Cardiome acknowledge and agree that information furnished pursuant to this Section 7.4 shall be subject to the terms and conditions of the Confidentiality Agreement; (b), Cardiome shall promptly notify Cipher of any significant developments or material changes relating the Retained Assets and the Retained Liabilities, promptly after becoming aware of any such development or change, and (c) each of Cipher and Correvio shall, and shall cause their subsidiaries and their respective Representatives to, as the case may be, work cooperatively and in good faith to ensure an orderly transition following the Effective Time, including with respect to transitional planning, transitional services, and the retention of personnel (and any related arrangements thereto).

 

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7.5 Insurance and Indemnification

 

(a) Prior to the Effective Date, Cardiome may purchase customary “run-off” policies of directors’ and officers’ liability insurance providing protection no less favourable in the aggregate to the protection provided by the policies maintained by Cardiome which are in effect immediately prior to the Effective Date and providing protection in respect of claims arising from facts or events which occurred on or prior to the Effective Date and Cipher will, or will cause Cardiome to, maintain such tail policies in effect without any reduction in scope or coverage for six (6) years from the Effective Date; provided that neither Cipher nor Cardiome shall be required to expend any funds in respect of this Section 7.5 following the Effective Time (and Correvio shall be solely responsible for maintaining such policies, including the payment of all costs and expenses associated therewith after the Effective Time).

 

(b) Following the Effective Time, Cardiome shall not be obligated to honour any rights to indemnification or exculpation now existing in favour of present and former officers or directors of Cardiome and any such Liabilities shall constitute Assumed Liabilities.

 

7.6 ROFR on New Canadian Products

 

(a) For the period commencing on the Effective Date and expiring on date that is five (5) years following the Effective Date, if Correvio or any of its affiliates receives from any Person a bona fide offer to license all or part of any pharmaceutical product that Correvio or its affiliates do not have any Canadian rights to on the date of this Agreement (each, a “ New Canadian Product ”), which Correvio is willing to accept (a  “Transfer Offer” ), whether in whole or in part (the  “Offered Interest” ), Correvio shall give written notice to Cipher of the Transfer Offer including all terms and of its intention to accept the Transfer Offer to Cipher.

 

(b) Within ninety (90) days after receipt by Cipher of the written notice of a Transfer Offer under Subsection 7.6(a) (the  “Option Period” ), Cipher (or, for the purposes of this Section 7.6, any affiliate of Cipher) shall be entitled to sublicense the Offered Interest on terms to be negotiated by and between Correvio and Cipher (the  “Right of First Refusal” ). Cipher shall, within the Option Period, notify Correvio of its desire (the  “Notice of Acceptance” ) to sublicense the Offered Interest. If Cipher fails to exercise its Right of First Refusal within the Option Period, Cipher will be deemed to have definitively waived such Right of First Refusal.

 

(c) If Cipher elects to exercise its Right of First Refusal, the parties shall use commercially reasonable efforts to complete such sublicense transaction within 60 days following the delivery of the Notice of Acceptance (or such longer period as may reasonably be required to comply with all applicable statutory and regulatory requirements or to obtain all required consents or as may be agreed to by Correvio and Cipher).

 

(d) If Cipher elects not to exercise, or is deemed to have waived, its Right of First Refusal, Correvio shall be entitled to thereafter sublicense the Offered Interest offered pursuant to the Transfer Offer to any Person or to commercialize the New Canadian Product itself.

 

(e) Notwithstanding the foregoing (or anything to the contrary in this Section 7.6), upon a change of control of either Cipher or Correvio (being the acquisition (directly or indirectly) by any Person or group of Persons acting jointly or in concert, of greater than 50% of the voting securities of either Cipher or Correvio) each of Cipher and Correvio shall have the right, exercisable at any time within thirty (30) days following the date of such change of control, to terminate the obligations of Cipher and Correvio under this Section 7.6.

 

7.7 Product Introduction Fee

 

(a) For the period commencing on the Effective Date and expiring on December 31, 2019, if Correvio or any of its affiliates introduces Cipher to any New Canadian Product and Cipher enters into a binding agreement to license all or part of such New Canadian Product as a result of such an introduction, Cipher shall pay $500,000 to Correvio by wire transfer of immediately available funds on the date that such binding agreement is entered into.

 

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Article 8
TERM, TERMINATION, AMENDMENT AND WAIVER

 

8.1 Term

 

This Agreement shall be effective from the date hereof until the earlier of the Effective Time and the termination of this Agreement in accordance with its terms.

 

8.2 Termination

 

(a) This Agreement may be terminated:

 

(i) at any time prior to the Effective Time by mutual written agreement of Cardiome and Cipher;

 

(ii) by either Cardiome or Cipher, if:

 

A. the Effective Time shall not have occurred on or before the Outside Date, except that the right to terminate this Agreement under this Subsection 8.2(a)(ii)A shall not be available to any Party whose failure to fulfil any of its obligations or breach any of its covenants, representations and warranties under this Agreement has been the cause of, or resulted in, the failure of the Effective Time to occur by the Outside Date;

 

B. any Governmental Entity shall have issued an order, decree or ruling or there shall be enacted or made any applicable Law that makes consummation of the Arrangement illegal or otherwise prohibited or otherwise restrains, enjoins or prohibits Cardiome or Cipher from consummating the Arrangement (unless such order, decree, ruling or applicable Law has been withdraw, reversed or otherwise made inapplicable) and such order, decree, ruling or applicable Law or enjoinment shall have become final and non-appealable; or

 

C. Cardiome Shareholder Approval shall not have been obtained at the Cardiome Meeting in accordance with applicable Laws and the Interim Order.

 

(iii) by Cipher, if:

 

A. prior to the Effective Time (1) the Cardiome Board shall have made a Change in Recommendation, (2) the Cardiome Board shall have approved or recommended an Acquisition Proposal, or (3) Cardiome shall have entered into a definitive agreement with respect to a Superior Proposal;

 

B. the Cardiome Meeting has not occurred on or before May 23, 2018 or such later date as may be agreed by Cardiome and Cipher in writing, provided that the right to terminate this Agreement pursuant to this Section 8.2(a)(iii)B shall not be available to Cipher if the failure by Cipher to fulfil any obligation hereunder is the cause of, or results in, the failure of the Cardiome Meeting to occur on or before such date; or

 

C. subject to Section 6.4, Cardiome or Correvio is in default of a covenant or obligation hereunder such that the condition contained in Subsection 6.2(a) would be incapable of satisfaction, or any representation or warranty of Cardiome or Correvio under this Agreement is untrue or incorrect or shall have become untrue or incorrect such that the condition contained in Subsection 6.2(b) would be incapable of satisfaction; provided that Cipher is not then in breach of this Agreement so as to cause any of the conditions set forth in Subsection 6.2(a) or Subsection 6.2(b) not to be satisfied.

 

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(iv) by Cardiome, if:

 

A. subject to Section 6.4, Cipher is in default of a covenant or obligation hereunder such that the condition contained in Subsection 6.3(a) would be incapable of satisfaction, or any representation or warranty of Cipher under this Agreement is untrue or incorrect or shall have become untrue or incorrect such that the condition contained in Subsection 6.3(b) would be incapable of satisfaction; provided that Cardiome is not then in breach of this Agreement so as to cause any of the conditions set forth in Subsection 6.3(a) or Subsection 6.3(b) not to be satisfied; or

 

B. at any time prior to receipt of the Cardiome Shareholder Approval, Cardiome wishes to enter into a definitive agreement with respect to a Superior Proposal (other than a confidentiality and standstill agreement permitted by Section 7.2), subject to, and in compliance with, Section 7.3.

 

(b) The Party desiring to terminate this Agreement pursuant to this Section 8.2 (other than pursuant to Subsection 8.2(a)(i)) shall give notice of such termination to the other Parties, specifying in reasonable detail the basis for such Party’s exercise of its termination right.

 

(c) If this Agreement is terminated pursuant to this Section 8.2, this Agreement shall become void and be of no further force or effect without Liability of any Party (or any shareholder, director, officer, employee, agent, consultant or representative of such Party) to any other Party hereto, except that the provisions of Section 7.5, this Subsection 8.2(c) and Sections 8.3, 8.4, 8.5, 10.1, 10.2, 10.3, 10.4, 10.6, 10.7 and 10.8 and all related definitions set forth in Section 1.1 and the provisions of the Confidentiality Agreement shall survive any termination of this Agreement; provided further that neither the termination of this Agreement nor anything contained in this Section 8.2 shall relieve a Party from any Liability arising prior to such termination.

 

8.3 Expenses

 

Except as otherwise provided herein, the Parties agree that all costs and expenses of the Parties relating to the Arrangement and the transactions contemplated in this Agreement, including legal fees, accounting fees, financial advisory fees, strategic advisory fees, regulatory filing fees, stock exchange fees, all disbursements of advisors and printing and mailing costs, shall be paid by the Party incurring such expenses. For greater certainty, any such costs or expenses of Cardiome shall not form part of the Retained Liabilities.

 

8.4 Termination Payments

 

(a) A Termination Payment shall be payable by Cardiome to Cipher in the event that the Agreement is terminated in the following circumstances (each being a “ Termination Payment Event ”):

 

(i) the termination of this Agreement pursuant to Subsection 8.2(a)(iii)A, 8.2(a)(iii)B or 8.2(a)(iii)C, in which case the Termination Fee shall be paid to Cipher as soon as practicable and in any event within two (2) Business Days of the day on which this Agreement is terminated;

 

(ii) the termination of this Arrangement Agreement pursuant to Subsection 8.2(a)(iv)B, in which case the Termination Fee shall be paid to Cipher prior to or concurrently with termination of this Agreement; or

 

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(iii) the termination of this Agreement pursuant to Subsection 8.2(a)(ii)A or 8.2(a)(ii)C if, in either case, prior to the earlier of the termination of this Agreement or the holding of the Cardiome Meeting, (A) a bona fide Acquisition Proposal, or the intention to make an Acquisition Proposal, with respect to Cardiome shall have been made to Cardiome or publicly announced by any Person (other than Cipher or any of its affiliates) and not withdrawn prior to the Cardiome Meeting, and (B) within nine (9) months after the date of termination of this Agreement or the holding of the Cardiome Meeting either (x) such Acquisition Proposal has been accepted, recommended or approved by the Cardiome Board and has not expired, been withdrawn or been publicly abandoned, or (y) any Person or company acquires, directly or indirectly, more than 50% of the issued and outstanding Cardiome Shares or more than 50% of the consolidated assets of Cardiome under such Acquisition Proposal, in which case the Termination Fee shall be paid to Cipher on the date the Cardiome Shares or assets of Cardiome are acquired as described in paragraph (y) above. For the purpose of this Subsection 8.4(b)(iii), the term "Acquisition Proposal" shall have the meaning ascribed to such term in Section 1.1, except that references to "20%" shall be deemed to be "50%".

 

(b) Cipher hereby acknowledges that the Termination Payment to which it may become entitled to is a payment of liquidated damages which is a genuine pre-estimate of the damages which such it will suffer or incur as a result of the event giving rise to such damages and the resultant non-completion of the Arrangement and the transactions contemplated by this Agreement and is not a penalty. Cipher hereby irrevocably waives any right it may have to raise as a defence that any such liquidated damages are excessive or punitive. Upon receipt by Cipher of any Termination Payment, Cipher shall have no further Claim against Cardiome or Correvio at Law or in equity or otherwise (including injunctive relief to restrain any breach or threatened breach by Cardiome of any of its obligations hereunder or otherwise to obtain specific performance).

 

8.5 Termination Payment to Cardiome

 

(a) In the event that Cardiome terminates this Agreement pursuant to Subsection 8.2(a)(iv)A of this Agreement, then Cipher shall pay to Cardiome $2,500,000 (the “ Cardiome Termination Fee ”) within two (2) Business Days of the day on which this Agreement is terminated.

 

(b) Cardiome hereby acknowledges that the Cipher Termination Payment to which it may become entitled to is a payment of liquidated damages which is a genuine pre-estimate of the damages which such it will suffer or incur as a result of the event giving rise to such damages and the resultant non-completion of the Arrangement and the transactions contemplated by this Agreement and is not a penalty. Cardiome hereby irrevocably waives any right it may have to raise as a defence that any such liquidated damages are excessive or punitive. Upon receipt by Cardiome of any Cipher Termination Payment, Cardiome shall have no further Claim against Cipher at Law or in equity or otherwise (including injunctive relief to restrain any breach or threatened breach by Cipher of any of its obligations hereunder or otherwise to obtain specific performance).

 

8.6 Amendment

 

Subject to the provisions of the Interim Order and Final Order, the Plan of Arrangement and applicable Laws, this Agreement and the Plan of Arrangement may, at any time and from time to time prior to the Effective Time, be amended only by mutual written agreement of Cipher and Cardiome, without further notice to or authorization on the part of the Cardiome Shareholders, and any such amendment may without limitation:

 

(a) change the time for performance of any of the obligations or acts of the Parties;

 

(b) waive any inaccuracies or modify any representation or warranty contained herein or in any document delivered pursuant hereto;

 

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(c) waive compliance with or modify any of the covenants herein contained and waive or modify performance of any of the obligations of the Parties; and

 

(d) waive compliance with or modify any mutual conditions precedent herein contained.

 

8.7 Waiver

 

Any Party may (a) extend the time for the performance of any of the obligations or acts of the other Party, (b) waive compliance, except as provided herein, with any of the other Party’s agreements or the fulfilment of any conditions to its own obligations contained herein, or (c) waive inaccuracies in any of the other Party’s representations or warranties contained herein or in any document delivered by the other Party, in each case only to the extent such obligations, agreements and conditions are intended for its benefit. No extension or waiver shall be valid unless set forth in an instrument in writing signed on behalf of such Party and, unless otherwise provided in the written waiver, will be limited to the specific breach or condition waived and shall not extent to any other matter or occurrence. No failure or delay in exercising any right, power or privilege under this Agreement will operate as a waiver thereof, nor will any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any right, power or privilege under this Agreement.

 

Article 9
INDEMNITY AND WARRANTY

 

9.1 Correvio Indemnity

 

(a) From and after the Effective Time, Correvio shall indemnify and save harmless Cipher and its subsidiaries and Cardiome and their respective directors, officers, employees and agents (the “ Cipher Indemnified Parties ”) in respect of any Claim, including relating to Taxes, and from and against any and all Losses arising in connection with or relating in any manner to:

 

(i) the Retained Assets or Retained Liabilities, in respect of the period prior to the Effective Time;

 

(ii) the Assigned Assets;

 

(iii) the Assumed Liabilities;

 

(iv) the Employee Obligations;

 

(v) all Contracts relating to the Assigned Assets, Assigned Liabilities or Employee Obligations;

 

(vi) the business or operations of Cardiome or its subsidiaries in respect of the period prior to the Effective Time, including any product liability claims in respect of products developed or commercialized by Cardiome or its subsidiaries;

 

(vii) the carrying out or implementation of the Pre-Closing Reorganization or the transactions contemplated by the Arrangement;

 

(viii) the exercise of any Dissent Rights by Dissenting Shareholders; or

 

(ix) all Taxes payable by Cardiome with respect to all periods ending on or before the Effective Date (including those arising as a result of the carrying out or implementation of the transactions contemplated by this Agreement, including the Arrangement).

 

  - 40 -  

 

  

(b) The obligations of Correvio under Subsection 9.1(a) shall survive the execution and delivery of this Agreement and the completion of the transactions contemplated by this Agreement, including the Arrangement, provided that:

 

(i) if a Claim or Loss relates to Subsection 9.1(a)(i), the obligations of Correvio shall survive for a period of two (2) years following the Effective Date and, provided further that: (A) no Losses may be recovered from Correvio pursuant to Subsection 9(a)(i) unless and until the accumulated aggregate amount of Losses of Cipher Indemnified Parties arising pursuant thereto exceeds $200,000, in which event the accumulated aggregate amount of all such Losses may be recovered; and (B) Correvio shall not be liable for any Losses pursuant to Subsection 9(a)(i) in excess of $3,000,000;

 

(ii) if a Claim or Loss relates to any of Subsection 9.1(a)(ii) to Subsection 9.1(a)(viii), inclusive, the obligations of Correvio shall survive until expiration of any limitation periods imposed by Law applicable to the subject matter of the Claim or Loss; or

 

(iii) if a Claim or Loss relates to Subsection 9.1(a)(ix), the obligations of Correvio shall survive until one year after the expiration of any limitation periods imposed by Law applicable to the relevant taxation year (giving effect to any waiver, mitigation or extension thereof).

 

(c) The rights to indemnification of the Cipher Indemnified Parties under Section 9.1(a) shall apply notwithstanding any investigation, inspection or inquiries made by or on behalf of any of the Cipher Indemnified Parties.

 

9.2 Cipher Indemnity

 

(a) From and after the Effective Time, Cipher shall indemnify and save harmless Correvio and its subsidiaries and their respective directors, officers, employees and agents (the “ Correvio Indemnified Parties ”) in respect of any Claim, and from and against any and all Losses, arising in connection with or relating in any manner to:

 

(i) the Retained Assets, in respect of the period following the Effective Time; or

 

(ii) the Retained Liabilities, in respect of the period following the Effective Time.

 

(b) The obligations of Cipher in under Subsection 9.2(a) shall survive the execution and delivery of this Agreement and the completion of the transactions contemplated by this Agreement, including the Arrangement, until expiration of any limitation periods imposed by Law applicable to the subject matter of the Claim or Loss.

 

(c) The rights to indemnification of the Correvio Indemnified Parties under Section 9.2(a) shall apply notwithstanding any investigation, inspection or inquiries made by or on behalf of any of the Correvio Indemnified Parties.

 

9.3 Taxable Gain Warranty

 

(a) Correvio warrants to Cipher that the aggregate amount of (i) income in excess of losses, and (ii) taxable capital gains in excess of allowable capital losses, in all cases realized by Cardiome as a result of the transactions contemplated in this Agreement, including the Arrangement, will not exceed $1,000,000.

 

(b) The warranty of Correvio under Subsection 9.3(a) shall survive the execution and delivery of this Agreement and the completion of the transactions contemplated by this Agreement, including the Arrangement, until one year after the expiration of any limitation periods imposed by Law applicable to the relevant taxation year (giving effect to any waiver, mitigation or extension thereof).

 

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9.4 Claim Notice

 

If an Indemnified Party becomes aware of any act, omission or state of facts that may give rise to Losses in respect of which a right of indemnification is provided or a claim for breach of warranty is permitted for under this Article 9, a Party entitled to and seeking indemnification pursuant to the terms of this Agreement (the “ Indemnified Party ”) shall promptly give written notice (a “ Claim Notice ”) to the Party responsible for indemnifying the Indemnified Party (the “ Indemnifying Party ”) of any claim for indemnification pursuant to Sections 9.1 or 9.2 (an “ Indemnification Claim ”, which term shall include more than one Indemnification Claim) or a claim for damages for breach of warranty pursuant to Section 9.3 (a “ Damages Claim ”). The Claim Notice shall specify whether Indemnification Claim or Damages Claim arises as a result of a claim by a Person against the Indemnified Party (a “ Third Party Claim ”) or whether the Indemnification Claim arises as a result of a claim directly by the Indemnified Party against the Indemnifying Party (a “ Direct Claim ”), and shall also specify with reasonable particularity (to the extent that the information is available):

 

(a) the factual basis for the Direct Claim or Third Party Claim, as the case may be; and

 

(b) the amount of the potential Damages Claim (“ Damages ”) or Losses arising from the Indemnification Claim, if known.

 

If, through the fault of the Indemnified Party, the Indemnifying Party does not receive a Claim Notice in time effectively to contest the determination of any Liability susceptible of being contested or to assert a right to recover an amount under applicable insurance coverage, then the liability of the Indemnifying Party to the Indemnified Party under this Article 9 shall be reduced to the extent that Losses or Damages are incurred by the Indemnifying Party resulting from the Indemnified Party’s failure to give the Claim Notice on a timely basis.

 

9.5 Agency for Non-Parties

 

Each Party hereby accepts each indemnity in favour of each of its Indemnified Parties who are not Parties as agent and trustee of that Indemnified Party. Each Party may enforce an indemnity in favour of any of that Party’s Indemnified Parties on behalf of each such Indemnified Party.

 

9.6 Procedure for Indemnification – Direct Claims

 

In the case of a Direct Claim, the Indemnifying Party shall have 45 days from receipt of a Claim Notice to make such investigation as the Indemnifying Party considers necessary or desirable. For the purpose of such investigation, the Indemnified Party shall make available to the Indemnifying Party the information relied upon by the Indemnified Party to substantiate its Indemnification Claim, together with all such other information as the Indemnifying Party may reasonably request. If the Indemnified Party and the Indemnifying Party agree at or prior to the expiration of such 45 day period (or any mutually agreed upon extension thereof) to the validity and amount of such Indemnification Claim, the Indemnifying Party shall immediately pay to the Indemnified Party the full agreed upon amount of the Indemnification Claim. If the Indemnified Party and the Indemnifying Party fail to agree at or before the expiration of such 45 day period (or any mutually agreed upon extension thereof), the Indemnified Party shall be free to pursue all remedies as may be available to it.

 

9.7 Procedure for Indemnification – Third Party Claims

 

(a) In the case of a Third Party Claim, the Indemnifying Party shall have the right, at its expense, to control the negotiation, settlement or defence of the Third Party Claim, through counsel of its choice (such counsel to be acceptable to the Indemnified Party, acting reasonably); provided, however, that notwithstanding the foregoing, the Indemnifying Party shall not be permitted to assume control of the negotiation, settlement or defence of the Third Party Claim if such Third Party Claim involves criminal liability.

 

  - 42 -  

 

  

(b) If the Indemnifying Party elects to assume control as contemplated in Subsection 9.9(a), the Indemnifying Party shall reimburse the Indemnified Party for all of the Indemnified Party’s out-of-pocket expenses incurred as a result of such assumption. The Indemnified Party shall continue to have the right to participate in the negotiation, settlement or defence of such Third Party Claim and to retain counsel to act on its behalf, provided that the fees and disbursements of such counsel shall be paid by the Indemnified Party unless the Indemnifying Party consents to the retention of such counsel at its expense or unless the named parties to any action or proceeding include both the Indemnifying Party and the Indemnified Party and the representation of both the Indemnifying Party and the Indemnified Party by the same counsel would be inappropriate due to the actual or potential differing interests between them (such as the availability of different defences), in which case the fees and disbursements of such counsel of the Indemnified Party shall be paid by the Indemnifying Party. The Indemnified Party shall co-operate with the Indemnifying Party so as to permit the Indemnifying Party to conduct and control such negotiation, settlement and defence and for this purpose shall preserve all relevant documents in relation to the Third Party Claim, allow the Indemnifying Party access on reasonable notice to inspect and take copies of all such documents and require its personnel to provide such statements as the Indemnifying Party may reasonably require and to attend and give evidence at any trial or hearing in respect of the Third Party Claim. If the Indemnifying Party, having elected to assume such control, thereafter fails to defend any such Third Party Claim within a reasonable time, the Indemnified Party shall be entitled to assume such control and the Indemnifying Party shall be bound by the results obtained by the Indemnified Party with respect to such Third Party Claim.

 

(c) If the Indemnifying Party assumes the defence of a Third Party Claim, it shall be deemed to have acknowledged its obligation to indemnify and hold the Indemnified Party harmless with respect to such Third Party Claim.

 

(d) If any Third Party Claim is of a nature such that the Indemnified Party is required by applicable Law to make a payment to any Person (a “ Third Party ”) with respect to such Third Party Claim before the completion of settlement negotiations or related legal proceedings, the Indemnified Party may make such payment and the Indemnifying Party shall, forthwith after demand by the Indemnified Party, reimburse the Indemnified Party for any such payment. If the amount of any Losses of the Indemnified Party under the Third Party Claim in respect of which such a payment was made, as finally determined, is less than the amount which was paid by the Indemnifying Party to the Indemnified Party, the Indemnified Party shall, forthwith after receipt of the difference from the Third Party, pay the amount of such difference to the Indemnifying Party with interest at the then current Court Order Interest Act rate.

 

(e) The Indemnifying Party shall not settle any Third Party Claim or conduct any related legal or administrative proceeding in a manner which would, in the opinion of the Indemnified Party, acting reasonably, have a material adverse impact on the Indemnified Party.

 

9.8 Cooperation

 

Each Indemnified Party and Indemnifying Party shall reasonably cooperate and assist each other in determining the validity of any Indemnification Claim by an Indemnified Party and otherwise in resolving such matters. Such assistance and cooperation will include providing reasonable access to information, records and documents relating to such matters and furnishing employees to assist in the investigation, defence and resolution of such matters.

 

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9.9 Holdback Amount

 

(a) To the extent that a Cipher Indemnified Party is entitled to Losses arising from an Indemnification Claim or Damages arising from a Damages Claim pursuant to this Agreement, then, in addition to any rights of set-off or other rights that such Cipher Indemnified Party may have at common law or otherwise, Cipher (on behalf of such Cipher Indemnified Party) shall have the right to set-off any Losses or Damages to which such Cipher Indemnified Party may be entitled to under this Agreement against the Holdback Amount (on a dollar-for-dollar basis), provided that: (i) in the event a Cipher Indemnified Party is required to satisfy any such Losses with an out-of-pocket cash payment to any Third Party, Cipher (on behalf of such Cipher Indemnified Party) may, in its sole discretion, require that Correvio satisfy any indemnification obligations hereunder relating to such Losses in cash; and (ii) if the aggregate amount of any Losses in respect of Indemnification Claims or Damages in respect of a Damages Claim exceeds the Holdback Amount, Correvio shall be required to satisfy all such amounts in excess of the Holdback Amount in cash.

 

(b) Notwithstanding the foregoing, and without in any manner limiting the rights of indemnification in favour of the Cipher Indemnified Parties under this Article 9, Cipher shall pay to Correvio the Holdback Amount, as follows:

 

(i) twenty-five percent (25%) of the Holdback Amount on the date that is three (3) months following the Effective Date,

 

(ii) twenty-five percent (25%) of the Holdback Amount on the date that is six (6) months following the Effective Date,

 

(iii) twenty-five percent (25%) of the Holdback Amount on the date that is nine (9) months following the Effective Date, and

 

(iv) twenty-five percent (25%) of the Holdback Amount on the date that is twelve (12) months following the Effective Date,

 

less, in each case, any amounts that are permitted to be deducted from, and subject to set-off against, the Holdback Amount pursuant to Subsection 9.9(a), as at each respective payment date.

 

9.10 Exclusive Remedy

 

After the Effective Date, the rights of the Parties hereto and the Indemnified Parties to indemnification relating to this Agreement or the transactions shall be strictly limited to those contained in this Article 9, and such indemnification rights shall be sole and exclusive remedies of the Parties hereto and the Indemnified Parties subsequent to the Effective Date with respect to any matter in any way relating to this Agreement or its subject or arising in connection herewith. Except as provided in this Article 9, no Claim shall be brought or maintained by any Party against any other Party, and no recourse be brought or granted against any of them, by virtue of or based upon any alleged misstatement or omission respecting an inaccuracy in or breach of any of the representations, warranties, or agreements of any of the Parties hereto set forth or contained in this Agreement . Notwithstanding the foregoing, nothing in this Agreement shall limit any Party’s remedies against another Party for fraud, willful misconduct, fraudulent misrepresentation or intentional misrepresentation.

 

9.11 No Double Recovery

 

An Indemnifying Party shall not be liable under any Indemnification Claim to the extent that the Losses that are the subject of the relevant Indemnification Claim have already been recovered in respect of another Indemnification Claim.

 

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9.12 Price Purchase Consideration Adjustment

 

To the extent permitted pursuant to applicable Laws, all payments made by or on behalf of an Indemnifying Party to an Indemnified Party in respect of any Indemnification Claim pursuant to this Article 9 shall be treated as adjustments to the Share Purchase Consideration for Tax purposes.

 

Article 10
GENERAL PROVISIONS AND MISCELLANEOUS

 

10.1 Privacy

 

Each Party shall comply with applicable privacy Laws in the course of collecting, using and disclosing personal information about identifiable individuals in connection with the transactions contemplated hereby (the “ Transaction Personal Information ”). Neither Party shall disclose Transaction Personal Information originally collected by the other Party to any Person other than to its advisors who are evaluating and advising on the transactions contemplated by this Agreement. If Cipher completes the transactions contemplated by this Agreement, Cipher shall not, following the Effective Date, without the consent of the individuals to whom such Transaction Personal Information relates or as permitted or required by applicable Law, use or disclose Transaction Personal Information originally collected by Cardiome:

 

(a) for purposes other than those for which such Transaction Personal Information was collected by Cardiome prior to the Effective Date; and

 

(b) which does not relate directly to the carrying on of the business of Cardiome or to the carrying out of the purposes for which the transactions contemplated by this Agreement were implemented.

 

The Parties shall protect and safeguard the Transaction Personal Information against unauthorized collection, use or disclosure. Cipher shall cause its advisors to observe the terms of this Section 10.1 and to protect and safeguard all Transaction Personal Information in their possession. If this Agreement shall be terminated, each Party shall promptly deliver to the other Party all Transaction Personal Information originally collected by such other Party in its possession or in the possession of any of its advisors, including all copies, reproductions, summaries or extracts thereof, except, unless prohibited by applicable Law, for electronic backup copies made automatically in accordance with the usual backup procedures of the Party returning such Transaction Personal Information.

 

10.2 Notices

 

All notices and other communications given or made pursuant to this Agreement shall be in writing and shall be deemed to have been duly given and received on the day it is delivered, provided, however, that it is delivered on a Business Day prior to 4:30 p.m. Vancouver time in the place of delivery or receipt. However, if notice is delivered after 4:30 p.m. Vancouver time or if such day is not a Business Day then the notice shall be deemed to have been given and received on the next Business Day. Notice shall be sufficiently given if delivered (either in Person, by courier service or other personal method of delivery), or if transmitted by email to the Parties at the following addresses (or at such other addresses as shall be specified by any Party by notice to the other given in accordance with these provisions):

 

(a) if to Cipher:

 

Cipher Pharmaceuticals Inc.

2345 Argentia Road, Suite 100A

Mississauga, Ontario L5N 8K4

 

Attention: Robert Tessarolo
Email: rtessarolo@cipherpharma.com

 

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with a copy (which shall not constitute notice) to:

 

Wildeboer Dellelce LLP

365 Bay Street, Suite 800

Toronto, ON M5H 2V1

 

Attention: James Brown
Email: jbrown@wildlaw.ca

 

(b) if to Cardiome or Correvio:

 

Cardiome Pharma Corp.

1441 Creekside Drive

6 th Floor

Vancouver, British Columbia V6J 4S7

 

Attention: Bill Hunter
Email: bhunter@cardiome.com

 

with a copy (that shall not constitute notice) to:

 

Blake, Cassels & Graydon LLP
595 Burrard Street
Suite 2600, Three Bentall Centre
Vancouver BC V7X 1L3

 

Attention: Joe Garcia
Email: joseph.garcia@blakes.com

 

10.3 Governing Law

 

This Agreement shall be governed, including as to validity, interpretation and effect, by the Laws of the Province of British Columbia and the Laws of Canada applicable therein, without giving effect to any principles of conflict of Laws thereof which would result in the application of the Laws of any other jurisdiction. Each of the Parties hereby irrevocably attorns to the exclusive jurisdiction of the courts of the Province of British Columbia in respect of all matters arising under and in relation to this Agreement and the Arrangement.

 

10.4 Injunctive Relief

 

Subject to Section 8.4 and Section 8.5, the Parties acknowledge and agree that irreparable harm would occur for which money damages would not be an adequate remedy at Law in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. Accordingly, the Parties agree that, in the event of any breach or threatened breach of this Agreement by a Party, the non-breaching Party will be entitled, without the requirement of posting a bond or other security, to equitable relief, including injunctive relief and specific performance, and the Parties shall not object to the granting of injunctive or other equitable relief on the basis that there exists an adequate remedy at Law. Subject to Section 8.4 and Section 8.5, such remedies will not be the exclusive remedies for any breach of this Agreement but will be in addition to all other remedies available at Law or equity to each of the Parties.

 

10.5 Time of Essence

 

Time shall be of the essence in this Agreement.

 

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10.6 Entire Agreement, Binding Effect and Assignment

 

This Agreement (including the exhibits and schedules hereto and the Cardiome Disclosure Letter) and the Confidentiality Agreement constitute the entire agreement, and supersede all other prior agreements and understandings, both written and oral, among the Parties, or any of them, with respect to the subject matter hereof and thereof and, except as expressly provided herein, this Agreement is not intended to and shall not confer upon any Person other than the Parties any rights or remedies hereunder. This Agreement shall enure to the benefit of and be binding upon the Parties and their respective successors and permitted assigns. Neither this Agreement nor any of the rights, interests or obligations hereunder may be assigned by any of the Parties without the prior written consent of the other Parties.

 

10.7 No Liability

 

No director or officer of Cipher shall have any personal liability whatsoever to Cardiome under this Agreement, or any other document delivered in connection with the transactions contemplated hereby on behalf of Cipher. No director or officer of Cardiome shall have any personal liability whatsoever to Cipher under this Agreement, or any other document delivered in connection with the transactions contemplated hereby on behalf of Cardiome.

 

10.8 Severability

 

If any term or other provision of this Agreement is invalid, illegal or incapable of being enforced by any rule or Law or public policy, all other conditions and provisions of this Agreement shall nevertheless remain in full force and effect so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner materially adverse to any Party. Upon such determination that any term or other provision is invalid, illegal or incapable of being enforced, the Parties shall negotiate in good faith to modify this Agreement so as to effect the original intent of the Parties as closely as possible in an acceptable manner to the end that the transactions contemplated hereby are fulfilled to the fullest extent possible.

 

10.9 Counterparts, Execution

 

This Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original but all of which together shall constitute one and the same instrument. The Parties shall be entitled to rely upon delivery of an executed facsimile or similar executed electronic copy of this Agreement, and such facsimile or similar executed electronic copy shall be legally effective to create a valid and binding agreement among the Parties.

 

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IN WITNESS WHEREOF the Parties have executed this Arrangement Agreement as of the date first written above by their respective officers thereunto duly authorized.

 

  CIPHER PHARMACEUTICALS INC.
   
  Per:  
    Name:  Robert Tessarolo
    Title:   President and CEO
     
  CARDIOME PHARMA CORP.
   
  Per:  
    Name:  William Hunter
    Title:    President and CEO
     
  CORREVIO PHARMA CORP.
   
  Per:  
    Name:  William Hunter
    Title:    President and CEO

 

Signature Page to Arrangement Agreement