Document:

Exhibit 10.4

 

LICENSE AGREEMENT

 

BETWEEN

 

ZEALAND PHARMA A/S

 

AND

 

HELSINN HEALTHCARE SA

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

1

 

TABLE OF CONTENTS

 

	
Article 1
    	
Definitions
    	
Page 3
    
	
 
    	
 
    	
 
    
	
Article 2
    	
Grant of Rights
    	
Page 9
    
	
 
    	
 
    	
 
    
	
Article 3
    	
Commercialization in   the Nordic Region
    	
Page 14
    
	
 
    	
 
    	
 
    
	
Article 4
    	
Technology Transfer and   Technical Support
    	
Page 15
    
	
 
    	
 
    	
 
    
	
Article 5
    	
Development and   Commercialization
    	
Page 16
    
	
 
    	
 
    	
 
    
	
Article 6
    	
Transfer of Compound   and Product
    	
Page 18
    
	
 
    	
 
    	
 
    
	
Article 7
    	
Payments to ZEALAND
    	
Page 19
    
	
 
    	
 
    	
 
    
	
Article 8
    	
Prosecution,   Maintenance and Enforcement of ZEALAND Patents
    	
Page 23
    
	
 
    	
 
    	
 
    
	
Article 9
    	
Representations and   Warranties
    	
Page 26
    
	
 
    	
 
    	
 
    
	
Article 10
    	
Indemnification
    	
Page 29
    
	
 
    	
 
    	
 
    
	
Article 11
    	
Confidentiality
    	
Page 30
    
	
 
    	
 
    	
 
    
	
Article 12
    	
Term and Termination
    	
Page 31
    
	
 
    	
 
    	
 
    
	
Article 13
    	
Effects of Termination
    	
Page 33
    
	
 
    	
 
    	
 
    
	
Article 14
    	
Governing Law and   Settlement of Disputes
    	
Page 34
    
	
 
    	
 
    	
 
    
	
Article 15
    	
Additional Terms
    	
Page 35
    
	
 
    	
 
    	
 
    
	
Exhibit 1
    	
Back Up Compounds
    	
Page 41
    
	
 
    	
 
    	
 
    
	
Exhibit 2
    	
Existing Agreements
    	
Page 57
    
	
 
    	
 
    	
 
    
	
Exhibit 3
    	
Tentative Development   Plan
    	
Page 63
    
	
 
    	
 
    	
 
    
	
Exhibit 4
    	
ZEALAND Know-How
    	
Page 56
    
	
 
    	
 
    	
 
    
	
Exhibit 5
    	
ZEALAND Patents
    	
Page 79
    
	
 
    	
 
    	
 
    
	
Exhibit 6
    	
Inventory materials to   be transferred to HELSINN
    	
Page 81
    
	
 
    	
 
    	
 
    
	
Exhibit 7
    	
List of documents on   Compound and Product
    	
Page 84
    
	
 
    	
 
    	
 
    
	
Exhibit 8
    	
Expert Procedure
    	
Page 79
    

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

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LICENSE AGREEMENT

 

This License Agreement (the “Agreement”) is entered into as of this 26th day of November, 2008 (the “Effective Date”) between ZEALAND PHARMA A/S, a corporation organized and existing under the law of Denmark and having its registered office at Smedeland 36, DK-2600 Glostrup, Denmark (“ZEALAND”), and HELSINN HEALTHCARE SA, a corporation organized and existing under the law of Switzerland and having its registered office at Via Pian Scairolo 9, CH-6912 Pazzallo Lugano, Switzerland (“HELSINN”). ZEALAND and HELSINN may be referred to herein as a “Party” or jointly as “Parties”.

 

WHEREAS

 

(i)            ZEALAND is a biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs;

 

(ii)           As a result of its discovery and development work, ZEALAND is the proprietary owner of certain know-how and patent applications concerning peptides and other compounds under pharmaceutical development,

 

(iii)          HELSINN has experience in developing, manufacturing, registering and commercializing pharmaceutical products worldwide, directly or through Third Parties,

 

(iv)          Having discovered and developed ZP1846 through its first Phase I clinical trial in the Licensed Field, ZEALAND intends to pursue the discovery and development of other innovative peptide-based drugs, including GLP-2 Analogue, for indications outside the Licensed Field;

 

(v)           As a result, ZEALAND intends to cease all work on ZP1846 inside or outside the Licensed Field and not pursue any work on other GLP-2 Analogue compounds in the Licensed Field, and seek a development partner to develop ZP1846 in the Licensed Field;

 

(vi)          ZEALAND and HELSINN entered into a Joint Confidentiality Agreement on October 29th, 2007 and into a non-binding Letter of Intent on May 18th, 2008 to facilitate the discussion and evaluation of a possible transaction between the Parties,

 

(vii)         ZEALAND desires to grant, and HELSINN desires to acquire from ZEALAND, exclusive worldwide rights and licenses to certain intellectual property, compounds and products, in accordance with the terms and conditions of this Agreement.

 

NOW, THEREFORE, in consideration of the mutual promises, covenants and conditions hereinafter set forth, the Parties hereto mutually agree as follows:

 

1.             DEFINITIONS

 

The following capitalized terms as used in this Agreement have the meanings respectively set forth in this Article:

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

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1.1.         “Affiliate” means an organization that controls, is controlled by or is under common control with a Party. For the purposes of this definition, the terms “controls,” “controlled by,” and “under common control with” as used with respect to any Party, means the possession (directly or indirectly) of fifty percent or more (>50%) of the voting stock of a subject entity with the power to vote, or the power in fact to control the management decisions of such entity.

 

1.2.         “Authority Approvals” means any and all approvals, registrations, licenses, permits or authorizations issued by the appropriate competent authorities in each country or region of the Territory, enabling the Products and/or Combination Products, to be lawfully marketed and commercialized in said country or region, including pricing and/or reimbursement approval if and where applicable.

 

1.3.         “Back-Up Compounds” means the compounds listed in the Back-Up Compounds Schedule.

 

1.4.         “Back-Up Compounds Schedule” means the schedule attached to this Agreement as Exhibit 1.

 

1.5.         “Calendar Year” means each twelve-month period commencing on January 1.

 

1.6.         “COGS” means the costs attributable to producing a Product calculated in accordance with International Financial Reporting Standards.

 

1.7.         “Combination Product” means any and all pharmaceutical forms of a product containing the Compound together with one or more other active pharmaceutical ingredient, including products containing Compound and said other active pharmaceutical ingredients in separate packaging and products containing Compound and said other active pharmaceutical ingredients in unitary dosage form.

 

1.8.         “Commercially Reasonable Efforts” shall mean such commercially reasonable efforts as are consistent with the efforts that a comparable Third Party in the pharmaceutical industry would employ for other products of a similar strategic importance and commercial value.

 

1.9.         “Compound” means (i) ZP1846 as well as any existing and future salts, pro-drugs and metabolites thereof or (ii) from the Designation Date, if applicable, any Designated Back-Up Compound, as well as any existing and future salts, pro-drugs and metabolites thereof.

 

1.10.       “Confidential Information” has the meaning set forth in Article 11.1 here below.

 

1.11.       “Control” means, with respect to a particular item of information or any intellectual property right or other tangible or intangible property, that (i) the applicable Party owns or has a license or sublicense to such item or right from a Third Party and (ii) has the ability to transfer ownership of or to grant access, license or sublicense in or to such right without violating any Law or the terms of any agreement with any Third Party or without requiring payment pursuant to the terms of any agreement with any Third Party.

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

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1.12.       “Designated Back-up Compound” has the meaning set forth at Article 2.5 here below.

 

1.13.       “Designation Date” has the meaning set forth in Article 2.5.1 here below.

 

1.14.       “Designation Period” has the meaning set forth at Article 2.5 here below.

 

1.15.       “EMEA” means the European Medicines Agency, or any successor institution responsible for Authority Approvals in the EU.

 

1.16.       “Encumbrance” means a mortgage, charge, pledge, lien, option, restriction, right of first refusal, right of pre-emption, third-party right or interest, other encumbrance or security interest of any kind, or another type of preferential arrangement (including, without limitation, a title transfer or retention arrangement) having similar effect.

 

1.17.       “EU” means the European Union as its membership may be altered from time to time.

 

1.18.       “Existing Agreements” means the agreements entered into prior to the Effective Date by ZEALAND with Third Parties with respect to all or any part of the subject matter of this Agreement, as listed in Exhibit 2 attached hereto.

 

1.19.       “Extension Compound” means a GLP-2 Analogue Compound other than the Compound, ZP1848 and [***].

 

1.20.       “Extension Due Diligence Period” has the meaning set forth at Article 2.7.3 here below.

 

1.21.       “Extension Exclusivity Period” has the meaning set forth at Article 2.7.1 here below.

 

1.22.       “Extension Indication” means the diagnosis, prevention and treatment of any indication in humans other than (i) indications in the Licensed Field, (ii) the indication of Crohn’s disease and (iii) the indication of Ulcerative Colitis.

 

1.23.       “FDA” means the United States Food and Drug Administration, or any successor institution responsible for Authority Approvals in the United States of America.

 

1.24.       “First Launch” means the first commercial sale of a Product in any country of the Territory after Authority Approval of such Product in such country is granted.

 

1.25.       “GLP-2 Analogue Compound” means any Glucagon Like Peptide (GLP)-2 analogue peptide.

 

1.26.       “HELSINN Know-How” means Know-How related to the Compound or Products that is Controlled by HELSINN as of the Effective Date and during the Term (but not including ZEALAND Know-How).

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

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1.27.       “HELSINN Patents” means Patents that (x) claim a priority date after the Effective Date, (y) are Controlled by HELSINN during the Term and (z) contain one or more claims specifically naming the Compound and/or the Products or Combination Products.

 

1.28.       “Intellectual Property” means all legal and beneficial rights (including future and contingent rights) in each of the following: patents, inventions, utility models, copyrights, trade and service marks, trade names, domain names, rights in logos and get-up, reputation and goodwill, inventions, confidential information, designs, data, databases, and all intangible rights and privileges of a similar nature to any of the above, in every case in any part of the world and whether or not registered; and including all granted registrations and all applications for registration and all rights and protections of a similar nature or having similar effect which may subsist anywhere in the world.

 

1.29.       “Issued Patent Claim” means a claim of any Patent that has not:

 

(i)            lapsed, expired or been withdrawn, canceled, abandoned or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise;

 

(ii)           been finally rejected or held invalid by a final decision of a Patent Authority from which no appeal has been or can be taken; or

 

(iii)          been held invalid or unenforceable in an unappealable decision of a court or competent body having jurisdiction (including a decision which was appealable, but which was not timely appealed).

 

1.30.       “Know-How” means any and all scientific, technical or proprietary information, ideas, results and data of any type including databases, processes, techniques, formulations, formulae, specifications, models, knowledge, skill, experience, procedures (including manufacturing procedures, test procedures, purification procedures and isolation procedures) and biological, chemical or other materials (including biological, chemical, toxicological, physical, analytical, safety, manufacturing, stability and quality control data) whether or not patentable.

 

1.31.       “Licensed Field” means the diagnosis, prevention and treatment of chemotherapy induced diarrhea (CID) in humans, radiotherapy induced diarrhea (RID) in humans and any other supportive care indications in humans for the prevention or treatment of symptoms and/or diseases caused by cancer treatments.

 

1.32.       “Major Market” means [***].

 

1.33.       “Net Sales” means the gross amount in local currencies invoiced in the Territory by HELSINN, its Affiliates or sub-licensees for sales of all Products and Combination Products to any non-Affiliated Third Party (excluding sales between HELSINN and its Affiliates or its sublicensees and sales between HELSINN’s Affiliates and their sub-licensees or between Helsinn’s Affiliates themselves) less customary deductions made under applicable accounting rules including the applicable GAAP (Generally Accepted Accounting Principles), or IFRS (International Financial Reporting Standards), as applicable, to the extent actually incurred,

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

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allowed, paid, accrued or specifically allocated, including but not limited to trade, quantity and cash discounts; returns and allowances for returned or rejected Product or Combination Product or retroactive price reductions, rebates; charges; sales, value added and other taxes on the sale of Products or Combination Product (other than income taxes); transportation, handling and insurance charges; chargebacks; corrections for overbilling; commissions allowed or paid to Third Party distributors, brokers or agents other than sales personnel, sales representatives and sales agents employed by HELSINN, its Affiliates or sub-licensees; the per unit cost of special delivery devices (including any per unit cost of assembling such special devices) that are used for administration of Products to the extent such cost is included in the gross amount invoiced; provided, however, that the amount deducted in respect of such special delivery device may not exceed 10% of the gross invoiced amount per unit of Product that includes such device. Special delivery devices shall not include conventional devices (e.g., tablets, standard syringes, suppositories and/or standard transdermal patches), and any other amounts paid on sale or dispensing of Product or Combination Product. Such deductions shall not include any amount related to bad debts. Net Sales shall also not include any sales of Product made by ZEALAND or its sub-licensees in the Nordic Region.

 

1.34.       “Non-Patent Countries” means those countries in which making, having made, using, distributing, selling, offering for sale, marketing, exporting or importing of Compound and/or Products (or Combination Product) for or in such countries is not covered by an Issued Patent Claim in a ZEALAND Patent.

 

1.35.       “Nordic Region” means Denmark, Finland, Iceland, Norway and Sweden and their associated territories, corresponding to the Faroe Islands, Greenland and Aland.

 

1.36.       “Other Compound” means any compound other than any GLP-2 Analogue Compound.

 

1.37.       “Other Compound Due Diligence Period” has the meaning set forth at Article 2.6.3 here below.

 

1.38.       “Other Compound Exclusivity Period” has the meaning set forth at Article 2.6.1 here below.

 

1.39.       “Patents” means all U.S, non-U.S., multinational or international patents and patent applications (including all provisional, divisional, continuation or continuation-in-part applications, renewals, reissues, reexaminations, extensions (including patent term extensions or supplementary protection certificates) utility models and equivalents of any of the foregoing).

 

1.40.       “Patent Countries” means those countries in which the making, having made, using, distributing, selling, offering for sale, marketing, exporting and importing of Compound (or its metabolites [***], in the event that HELSINN decides to develop and commercialize said metabolites or any of them as Designated Back-Up Compounds in lieu of ZP1846) for or in such countries is covered by an Issued Patent Claim covering the Compound (or such metabolites) in a ZEALAND Patent.

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

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1.41.       “Products” means (I) a pharmaceutical product containing the Compound as active pharmaceutical ingredient and (ii) any formulations of (i), excluding however the Combination Products.

 

1.42.       “Steering Committee” has the meaning set forth at Article 5.5 here below.

 

1.43.       “Tentative Development Plan” means the non-binding plan for the development of the Compound for Chemotherapy Induced Diarrhea attached hereto as Exhibit 3 as the same may be amended from time to time by HELSINN as provided at Article 5.1 here below.

 

1.44.       “Term” has the meaning set forth at Article 12.1 here below.

 

1.45.       “Territory” means all countries worldwide.

 

1.46.       “Third Party” means any person or entity other than ZEALAND, HELSINN or their respective Affiliates.

 

1.47.       “Transfer Period” has the meaning set forth at Article 4.1 here below

 

1.48.       “ZEALAND Designated Compound” has the meaning set forth at Article 2.5.4 here below.

 

1.49.       “ZEALAND Know-How” means any and all Know-How related to the Compound and/or the Products, which is Controlled by ZEALAND as of the Effective Date of this Agreement and/or throughout the Term. The ZEALAND Know-How Controlled by ZEALAND as of the Effective Date is identified in Exhibit 4 attached to this Agreement.

 

1.50.       “ZEALAND Patents” means the patents and patent applications owned by ZEALAND as listed in Exhibit 5 attached to this Agreement; (b) all patents arising from said applications; (c) any additions, divisions, continuations, continuations-in-part, amendments, amalgamations, reissues and re-examinations of such applications or patents; (d) any confirmation thereof; and (e) any extensions and renewals of all such patents and patent applications in whatever legal form and by whatever legal title they are granted.

 

1.51.       “ZP1846” means [***].

 

1.52.       “ZP1848” means [***].

 

1.53.       “ZP[***]” means [***].

 

1.54.       “ZP[***]” means [***].

 

1.55.       “ZP[***]” means [***].

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

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2.             GRANT OF RIGHTS

 

2.1.         License Grant.    Subject to Article 3 here below, ZEALAND hereby grants to HELSINN, and HELSINN hereby accepts, a worldwide, perpetual, royalty-bearing and exclusive (even as to ZEALAND) license under the ZEALAND Know-How and the ZEALAND Patents, to, directly or indirectly, research, develop, make, have made, register, use, import, export, manufacture, distribute, sell, offer for sale, market, and otherwise transfer the Compound, the Products and the Combination Products in the Licensed Field. This license includes [***].

 

2.2.         Freedom to Operate.         In addition to the license granted in Article 2.1, ZEALAND grants to HELSINN and its Affiliates a non-exclusive license under all Patents and Know-How (i) Controlled by ZEALAND, during the Term and (ii) that are necessary to develop, make, have made, register, use, import, export, manufacture, distribute, sell, offer for sale, market, and otherwise transfer the Compound, the Products and Combination Products in the Licensed Field.

 

2.3.         Trademarks and Domain Names.

 

2.3.1       HELSINN shall have the right to select all trademarks, trade names and domain names connected with the Compound, the Products and the Combination Products and such trademarks, trade names and domain names will be the exclusive property of HELSINN.

 

2.3.2       ZEALAND is prohibited from registering or, except as provided at Article 3.1.1 below, using any trademarks, trade names and domain names in connection with the Compound, the Products and the Combination Products.

 

2.3.3       HELSINN shall submit a proposal for a recommended international non-proprietary name for the Compound to the World Health Organization at any time deemed appropriate by HELSINN, in accordance with the relevant rules of procedure in force at the time of the application.

 

2.4.         Sublicenses.          HELSINN shall be permitted to grant sublicenses under this Agreement to its Affiliates and/or to any Third Party, which sublicenses may include the right of such sub-licensees to grant further sublicenses. Each sublicense granted by HELSINN or its Affiliate or sub-licensee shall be consistent with the terms and conditions of this Agreement and subordinate thereto. HELSINN shall provide ZEALAND no later than June 30th and December 31st in each Calendar Year throughout the Term with a list of all sublicense agreements entered into with Third Parties with respect to the Compound, the Products and the Combination Products.

 

2.5.         Back-Up Compounds.       At any time throughout a period of [***] (the “Designation Period”) and in accordance with the provisions of Article 5.2 below, Helsinn shall have the right at its discretion to designate one of the Back-Up Compounds listed in the Back-Up Compounds Schedule as a replacement compound to be developed in place of ZP1846 (the “Designated Back-Up Compound”); provided, however, that:

 

2.5.1.      HELSINN shall designate such Designated Back-Up Compound by notice in writing to ZEALAND and from the date of such written notice (the “Designation Date”), (i) all references to the Compound contained in this Agreement shall be interpreted as referring to such Designated Back-Up Compound, (ii) this Agreement and the license

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

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granted under Article 2.1 of this Agreement shall terminate with regard to ZP1846 or the first Designated Back-Up Compound, as the case may be (while the license granted under Article 2.2 shall remain in full force and will continue to include any ZEALAND Know-How and ZEALAND Patents relevant to ZP1846 or the First Designated Back-Up Compound), (iii) the licenses granted to HELSINN with respect to the Compound in Article 2 above shall take effect with respect to the first or second Designated Back-Up Compound, as the case may be, and (iv) the consequences provided for at Articles 13.1.1 and 13.1.2 shall apply with exclusive regard to ZP1846 or the first Designated Back-Up Compound;

 

2.5.2.      HELSINN may not designate more than one compound as a Designated Back-Up Compound at any one time during the Designation Period;

 

2.5.3.      HELSINN may not designate more than two (2) compounds as Designated Back-Up Compounds during the Designation Period;

 

2.5.4.      During the Designation Period, ZEALAND shall have the right to designate any compound included in the Back-Up Compounds Schedule as a compound that ZEALAND, directly or through its sub-licensees, intends in good faith to develop (a “ZEALAND Designated Compound”), provided, however, that:

 

(i)            at the time that ZEALAND designates such compound as a ZEALAND Designated Compound, it is not designated by HELSINN as a Designated Back-Up Compound,

 

(ii)           at all times during the Designation Period there shall be at least two/third of the compounds in the Back-Up Compound Schedule that have not been designated as ZEALAND Designated Compounds,

 

(iii)          once a Back-Up Compound has been designated as a ZEALAND Designated Compound, such ZEALAND Designated Compound shall be deemed to be deleted from the Back-Up Compounds Schedule and be removed from the scope of this Agreement and HELSINN may not designate it as a Designated Back-Up Compound.

 

2.6.         First Refusal Right on Other ZEALAND Compounds in the Licensed Field.  ZEALAND shall promptly notify HELSINN in writing of the results of any evaluation carried out by ZEALAND (except as a contract researcher for a Third Party) or any Third Party on behalf of ZEALAND relating to any Other Compound for use in any indication in the Licensed Field. In this case the following rules will apply:

 

2.6.1.      HELSINN shall have thirty (30) days from the date it receives said written notification from ZEALAND (the “Other Compound Exclusivity Period”) to notify ZEALAND in writing that it is interested in performing a due diligence evaluation in anticipation of the possible negotiation of a license granting HELSINN the rights to

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

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research, develop, manufacture and commercialize such Other Compound for use in the Licensed Field.

 

2.6.2.      During such Other Compound Exclusivity Period, ZEALAND shall not solicit, encourage others to solicit, or encourage or accept any offers for the grant of any right to a Third Party for the research, development, manufacture or commercialization of such Other Compound in the Licensed Field.

 

2.6.3.      In the event that HELSINN notifies ZEALAND in writing before the expiration of the Other Compound Exclusivity Period that it is interested in performing a due diligence evaluation with respect to the Other Compound, then for a period of sixty (60) days from the date of such notification (the “Other Compound Due Diligence Period”), ZEALAND shall permit HELSINN and HELSINN’s representatives to have such access to ZEALAND’s facilities, records, Intellectual Property, data, legal and patent attorney advice (under such appropriate agreement as shall be necessary to preserve privilege of attorney’s advice), related documents and relevant personnel as is reasonably required to conduct and complete such due diligence evaluation in connection with a potential license for the research, development, manufacture and commercialization of such Other Compound in the Licensed Field.

 

2.6.4.      In the event that HELSINN notifies ZEALAND in writing before the expiration of the Other Compound Due Diligence Period that it is interested in negotiating a license to grant HELSINN the rights to research, develop, manufacture and commercialize such Other Compound in the Licensed Field, then ZEALAND and HELSINN shall negotiate in good faith the terms and conditions of such potential extension of the license for a period of no less than ninety (90) days.

 

2.6.5.      If at any time throughout a period of [***], ZEALAND would seek to offer to any Third Party rights to such Other Compound for use in the Licensed Field on terms which, when taken as a whole, are more favorable to such Third Party than those last offered to HELSINN, then ZEALAND shall offer such more favorable terms to HELSINN prior to the offer to the Third Party and HELSINN shall have fourteen (14) days from the date of ZEALAND’s written notice to accept or reject such offer.

 

2.6.6.      Nothing contained in this Article 2.6 shall affect the right of ZEALAND to solicit, encourage others to solicit, or encourage or accept any offers for the license to a Third Party for the research, development and commercialization of such Other Compound in the Licensed Field following expiration of the Other Compound Exclusivity Period.

 

2.7.         Field Extensions.                ZEALAND shall promptly notify HELSINN in writing of the results any evaluation carried out by ZEALAND (except as a contract researcher for a Third Party) or any Third Party on behalf of ZEALAND relating to an Extension Compound for use in an Extension Indication. In this case the following rules will apply:

 

2.7.1.      HELSINN shall have thirty (30) days from the date it receives said written notification from ZEALAND (the “Extension Exclusivity Period”) to notify ZEALAND

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

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in writing that it is interested in performing a due diligence evaluation in anticipation of the possible negotiation of an extension of the Licensed Field hereunder, with respect to the Compound only.

 

2.7.2.      During such Extension Exclusivity Period, ZEALAND shall not solicit, encourage others to solicit, or encourage or accept any offers for the grant of any right to a Third Party for the research, development, manufacture or commercialization of such Extension Compound in such Extension Indication.

 

2.7.3.      In the event that HELSINN notifies ZEALAND before the expiration of the Extension Exclusivity Period that it is interested in performing a due diligence evaluation with respect to such Extension Indication, then for a period of sixty (60) days from the date of such notification (the “Extension Due Diligence Period”), ZEALAND shall permit HELSINN and HELSINN’s representatives to have such access to ZEALAND’s facilities, records, Intellectual Property, data, legal and patent attorney advice (under such appropriate agreement as shall be necessary to preserve privilege of attorney’s advice), related documents and relevant personnel as is reasonably required to conduct and complete such due diligence evaluation in connection with a potential license for the extension of the Licensed Field, with respect to the Compound only, to include the Extension Indication.

 

2.7.4.      In the event that HELSINN informs ZEALAND before the expiration of the Extension Due Diligence Period that it is interested in extending the Licensed Field to include the Extension Indication, then ZEALAND and HELSINN shall negotiate in good faith the terms and conditions of such potential extension of the Licensed Field hereunder to include the Extension Indication, with respect to the Compound only, for a period of no less than ninety (90) days.

 

2.7.5.      If at any time throughout a period of [***], ZEALAND would seek to offer to any Third Party rights to such other Extension Compound for use in the Extension Indication on terms which, when taken as a whole, are more favorable to such Third Party than those last offered to HELSINN, then ZEALAND has the obligation to offer such more favorable terms to HELSINN prior to the offer to the Third Party and HELSINN shall have fourteen (14) days from the date of ZEALAND’s written notice to accept or reject such offer.

 

2.7.6.      Nothing contained in this Article 2.7 shall affect the right of ZEALAND to solicit, encourage others to solicit, or encourage or accept any offers for the license to a Third Party for the research, development and commercialization of such GLP-2 Analogue Compound in such Extension Indication following expiration of the Extension Exclusivity Period.

 

2.7.7.      HELSINN shall also have the right at any time throughout the Term to investigate and evaluate possible uses of the Compound and Product outside the Licensed Field and to propose to ZEALAND the inclusion of any Extension Indication in this Agreement by means of an appropriate addendum to be negotiated in good faith by the

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

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Parties. It is however understood that in case of any Extension Indication proposed by HELSINN, the negotiations between the Parties shall be conducted under exclusive conditions for a period of one hundred and eighty (180) days from the date of such proposal by HELSINN. ZEALAND shall be entitled to solicit, encourage others to solicit, or encourage or accept any offers for the license to a Third Party for the research, development and commercialization of a GLP-2 Analogue Compound in such Extension Indication only following definitive termination of the negotiations with HELSINN (subject always to the provisions of Article 2.7.5 here above).

 

2.8.         Improvements.    Subject to the terms of this Agreement, HELSINN has the right to develop and carry out, directly or indirectly, and to license to Third Parties, whatever improvement, addition, refinement, modification or development, whether patentable or not, it deems fit with respect to the Compound and the Products and the Combination Products in the Licensed Field.

 

2.8.1.      HELSINN will be the exclusive owner of any and all improvements, additions, refinements, modifications or developments, and of any resulting Patents and other Intellectual Property generated, with regard to the Compound and/or the Products and the Combination Products in the Licensed Field which are conceived, reduced to practice, or otherwise developed (i) by HELSINN and/or any of its Affiliates or sub-licensees or any employee, agent or other person acting on behalf of HELSINN without the involvement of ZEALAND and/or any of its Affiliates or sub-licensees, or any employee, agent or other person acting on behalf of ZEALAND, or (ii) by ZEALAND in the course of development activities where ZEALAND has been engaged by HELSINN to perform certain work as a contract research organization under the direction of HELSINN. To the extent that any Intellectual Property arises from such improvements that is not owned by HELSINN, then ZEALAND by this Agreement assigns such Intellectual Property to HELSINN. ZEALAND will provide all necessary assistance to HELSINN to transfer ownership to HELSINN and to register and extend any registrable Intellectual Property.

 

2.8.2.      Subject to Article 2.8.1, ZEALAND and HELSINN will be the joint owners of all improvements, additions, refinements, modifications or developments, and of any resulting patents generated, with regard to the Compound and/or the Products and the Combination Products in the Licensed Field which are jointly conceived, reduced to practice, or otherwise developed by HELSINN and/or any of its Affiliates or sub-licensees, or any employee, agent or other person acting on behalf of HELSINN, on the one hand, and by ZEALAND and/or any of its Affiliates or sub-licensees, or any employee, agent or other person acting on behalf of ZEALAND, on the other hand (so as to establish joint inventorship in the case of Patents).

 

2.8.3.      It is understood and agreed that any said Patents on improvements as mentioned at Articles 2.8.1 or 2.8.2 above shall not be considered as included in the ZEALAND Patents for the purposes of this Agreement. For the purpose of clarity, it is expressly understood that, irrespective of the existence of any Patent covering any said improvements, royalties on Net Sales of Products (or Combination Products) incorporating

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

13

 

any said improvement shall be paid at the rate provided for Patent Countries only in the case that and for as long as such Product or Combination Product is covered by a valid and subsisting ZEALAND Patent, and thereafter at the rate provided for Non-Patent Countries until expiration of a period of ten (10) years from First Launch.

 

2.9.         ZEALAND Activities. The exclusive right and license granted in Article 2.1 means that, except as provided at Article 3 below, ZEALAND has no right to grant to Third Parties any right or license on or in relation to the Compound and/or the Products and Combination Products in the Licensed Field in the Territory, nor the right to exploit said Compound and/or Products and Combination Products in the Licensed Field, in any way whatsoever. In order to adequately protect the value of the licenses granted hereunder in the Licensed Field, and considering that other ZEALAND compounds, which are not included in the licenses granted hereunder, could equally be developed for indications outside the Licensed Field, ZEALAND shall not during the Term undertake any investigation. development or commercialization, directly and/or through Third Parties, of (i) the Compound inside or outside the Licensed Field, and/or of (ii) any GLP-2 Analogue Compounds in the Licensed Field, unless the investigation and development of the Compound is undertaken by ZEALAND on behalf of HELSINN as contract research contemplated at Article 5.4 here below.

 

3.                                      COMMERCIALIZATION IN THE NORDIC REGION

 

3.1.         Commercialization Principles. HELSINN shall notify ZEALAND within [***].

 

3.1.1.      If ZEALAND notifies HELSINN within [***], then HELSINN will grant to ZEALAND an [***] license (with the right to sub-license and further sub-license) under any Product-related Patents, Know-How and trademarks Controlled by HELSINN, including the ZEALAND Know-How, the ZEALAND Patents, and any HELSINN Know-How and HELSINN Patents, to market and sell the Product in the Nordic Region, by means of an appropriate agreement which will include, inter alia, the following provisions:

 

(i)            The right to market and sell the Product and the license of the trademark will be granted by HELSINN to ZEALAND [***], for sales of the Product by ZEALAND or its sub-licensees in the Nordic Region;

 

(ii)           HELSINN shall put at ZEALAND’s disposal the dossier filed for Authority Approval at EMEA;

 

(iii)          Any ZEALAND’s sub-licensees shall have to be previously approved in writing by HELSINN, which shall not unreasonably withhold or delay such approval;

 

(iv)          ZEALAND shall undertake, directly or through its sub-licensees, to any minimum marketing and promotional commitment of such reasonable number of sales representatives, as well as to any minimum amount of medical and marketing promotional investments, as mutually agreed in good faith by the Parties as adequate to effectively cover the Nordic Region;

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

14

 

(v)           HELSINN shall supply to ZEALAND or its sub-licensees, as indicated by ZEALAND, the Product to be marketed and sold in the Nordic Region by ZEALAND or its sub-licensees [***];

 

(vi)          ZEALAND shall launch the Product in each country of the Nordic Region, directly or through its sub-licensees within [***] months from the relevant Authority Approval;

 

(vii)         ZEALAND shall use Commercially Reasonable Efforts to achieve, directly or through its sub-licensees, reasonable minimum performance obligations (including but not limited to minimum sales level in each country of the Nordic Region);

 

(viii)        ZEALAND shall at all time comply, and shall cause its sub-licensees to comply, with any pharmacovigilance or product safety requirements in force in any country of the Nordic Region or reasonably established by HELSINN to ensure appropriate product and patient safety;

 

(ix)          In the event of termination of such agreement, ZEALAND will facilitate an effective and swift transfer of all information and materials as necessary for HELSINN or its sub-licensee to comply with its regulatory obligations and to market and sell the Product in the Nordic Region.

 

3.2.         HELSINN’s Rights.            If ZEALAND does not notify HELSINN of its intention to commercialize the Product pursuant to Article 3.1.1, or the agreement mentioned at Article 3.1.1 terminates, then HELSINN shall be free to exploit the licenses granted hereunder in the Nordic Region directly and/or through Third Parties as for any other countries of the Territory.

 

3.3.         Combination Products.     The terms and conditions set forth in this Article 3 (with the exception of Article 3.1.1(i)) shall also apply to Combination Products, subject however in this case to previous agreement between the Parties on the economic terms of the relevant license to ZEALAND.

 

4.             TECHNOLOGY TRANSFER AND TECHNICAL SUPPORT

 

4.1.         Transfer of ZEALAND Know-How.             As soon as practicable after the Effective Date, but no later than six (6) months after the Effective Date (the “Transfer Period”), ZEALAND shall provide to HELSINN all ZEALAND Know-How existing at the Effective Date hereof as listed in Exhibit 4. In addition, ZEALAND shall, no later than June 30th and December 31’ in each Calendar Year throughout the Term, disclose and transfer to HELSINN any and all further ZEALAND Know-How becoming Controlled by ZEALAND throughout the Term.

 

4.2.         Transfer Support During the Transfer Period, ZEALAND shall provide reasonable assistance to HELSINN in interpreting and understanding the ZEALAND Know-How to facilitate the effective transfer of ZEALAND Know-How

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

15

 

4.3.         Transition Coordinator.  ZEALAND and HELSINN shall each appoint a transition coordinator who shall serve as a liaison among the Parties and will be responsible for coordinating the initial transfer of the ZEALAND Know-How pursuant to Article 4.1.

 

4.4.         Ongoing Support.               ZEALAND shall provide reasonable assistance to HELSINN in interpreting and understanding, the ZEALAND Know-How throughout the Term including facilitating direct contacts between HELSINN and any Third Party manufacturers of, and/or other providers of services related to, the Compound existing at the Effective Date; provided that HELSINN shall reimburse ZEALAND at an FTE rate of [***] for any support that ZEALAND provides to HELSINN after the Transfer Period. Any amount to be paid by HELSINN to ZEALAND in connection hereto during the 2009 Calendar Year shall be deducted from [***] that HELSINN is obliged to put onto ZEALAND pursuant to Article 5.4 below.

 

4.5.         Access to Raw Data.           If reasonably required by HELSINN, ZEALAND shall, upon reasonable notice from HELSINN, provide HELSINN with an opportunity to review any original documentation and raw data relevant to the Compound and/or the Product.

 

5.             DEVELOPMENT AND COMMERCIALIZATION

 

5.1.         Development Plan.             HELSINN shall use Commercially Reasonable Efforts to develop and seek Authority Approval for a Product or Combination Product in the indication of Chemotherapy Induced Diarrhea in accordance with the timelines indicated in the Tentative Development Plan attached as Exhibit 3 hereto, and to commercialize such Product or Combination Product for the indication of Chemotherapy Induced Diarrhea in all of the Major Markets. ZEALAND acknowledges that the Tentative Development Plan at the Effective Date is based on HELSINN’s good faith evaluation and knowledge of ZP1846 and its potential for development for the indication of Chemotherapy Induced Diarrhea. Said Tentative Development Plan may be reasonably amended by HELSINN at any time taking into consideration the actual progress of the development hereof, being understood that HELSINN shall send to ZEALAND at the end of each Calendar Year an updated version of the Tentative Development Plan, which shall each time be considered as the new Exhibit 3 attached hereto in substitution for the previous version.

 

5.2.         Development of a Back-Up Compound.       Before HELSINN may designate a Back-Up Compound as a Designated Back-Up Compound pursuant to Article 2.5 above, HELSINN shall provide to ZEALAND a tentative development plan for such Back-Up Compound that is based on HELSINN’s good faith evaluation of such Back-Up Compound and its potential for development for the indication of Chemotherapy Induced Diarrhea and shall reasonably consider, but will not be obliged to follow, ZEALAND’s comments in this respect, to substitute such development plan as Exhibit 3 to this Agreement with effect from the Designation Date of such Designated Back-Up Compound.

 

5.3.         Development Reports.       HELSINN shall provide ZEALAND twice a year with written reports on research and development progress for the Compound, the Products and Combination Products, including substantial events related to this Agreement, such as the initiation and results of clinical phases and the filing of significant regulatory documents. Such development

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

16

 

reports shall be provided to ZEALAND in advance of the meetings of the Steering Committee mentioned at Article 5.5 below.

 

5.4.         ZEALAND Engagement in Development Activities. HELSINN shall engage ZEALAND as a contract research organization to perform development and consultation services in relation to the Compound as they shall be identified and defined by HELSINN and put work onto ZEALAND for a minimum amount of [***]. ZEALAND will commit to perform said services for HELSINN in accordance with HELSINN’s reasonable directions and instructions. ZEALAND shall issue invoices at the end of each calendar quarter on the basis of the work actually done and HELSINN shall pay ZEALAND within thirty (30) days of receiving such invoice. HELSINN will be the exclusive owner of any and all Know-How and Patents generated in the course of such activities and services and ZEALAND by this Agreement assigns all relevant Intellectual Property to HELSINN. ZEALAND shall provide all necessary assistance to HELSINN to transfer ownership of such Intellectual Property to HELSINN and to register and extend any registrable Intellectual Property.

 

5.5.         Steering Committee. Within sixty (60) days from the Effective Date hereof, the Parties shall establish a steering committee composed of three (3) senior representatives from each Party (the “Steering Committee”). Each Party shall communicate to the other Party the names and functions of its representatives in the Steering Committee. Each representative may be replaced by the appointing Party at any time by written notice to the other Party. The Steering Committee shall meet at least two (2) times per year (one time in Switzerland, one time in Denmark) until filing of the first application for an Authority Approval in any of the Major Markets. Additional meetings may be organized as may be deemed opportune by both Parties. Each Party shall bear its own expenses in participating in the Steering Committee.

 

5.5.1.      The Steering Committee shall:

 

(i)            discuss and advise generally on the interpretation of the ZEALAND Know-How;

 

(ii)           discuss and advise generally on the global development plan for the Product;

 

(iii)          discuss and advise generally on the results of preclinical and clinical studies;

 

(iv)          discuss and advise generally on any other issue as may be deemed appropriate or advisable by both Parties; and

 

(v)           discuss and advise generally in relation to the Compound, the Products and the Combination Products.

 

5.5.2.      The role of the Steering Committee shall be advisory in nature, with the main purpose of serving as a forum for the sharing of information and facilitating communications and discussions between the Parties. HELSINN shall have no obligation

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

17

 

to follow any recommendations of the Steering Committee and shall at all times be free to ultimately decide on all steps to be taken in connection with, and have sole responsibility for, the development and/or, subject to Article 3 above, the commercialization of the Product or Combination Product, including but not limited to any decision regarding suspension or withdrawal of the Product or Combination Product from any market in the Territory.

 

6.                                      TRANSFER OF COMPOUND AND PRODUCT

 

6.1.         Transfer of existing materials.      ZEALAND hereby transfers to HELSINN [***] the property and all of its rights, titles and interests with full title guarantee in all Compound and Product (as well as in all standards related to the Compound, intermediates, key starting materials, impurities, degradation products as well as all retained samples for the Compound, intermediates and key starting materials for the manufactured lots as well as all samples of metabolites, [***] and any other research materials) in its possession or control. Upon execution hereof, all such materials become the exclusive property of HELSINN, which shall be free to use them as it will deem appropriate, subject to this Agreement, all applicable laws and regulations.

 

Notwithstanding the above, ZEALAND shall not be obliged to provide to HELSINN any intermediates and/or starting material which is also used by ZEALAND in connection with different development programs or compounds, as well as any material which ZEALAND is required to keep due to legal and/or regulatory obligations.

 

The materials to be transferred by ZEALAND to HELSINN are set forth in Exhibit 6 attached to this Agreement, which specifies quantities, use, and places where said materials are stored at the Effective Date and, if different, the relevant place of destination.

 

As soon as reasonably possible following HELSINN request, ZEALAND shall cause the materials set forth in Exhibit 6 to be shipped to HELSINN or to a location directed by HELSINN, acting reasonably; provided, however, that HELSINN shall be responsible for all shipment and insurance costs with respect to such shipment of materials.

 

ZEALAND will continue to manage the storage of said materials and relevant stabilities on behalf of HELSINN, which will reimburse ZEALAND for the documented costs thereof, until execution by HELSINN of appropriate agreements with the sites where such materials are stored. Risk of loss with respect to the materials to be transferred to HELSINN shall pass to HELSINN upon the earlier of the receipt by a Third Party for shipment of said materials to the location designated by HELSINN, or three months from the Effective Date.

 

6.1.1.      All GMP materials, including the Compound and Product described in Exhibit 6 hereto, intended for clinical use, are covered by appropriate certificates of analysis, certificates of GMP compliance as listed in Exhibit 7 attached hereto and by a retest date declaration according to the last stability data generated. With regard to Product for clinical use, the retest declaration is signed by a ZEALAND responsible person based

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

18

 

on documentation which has been provided by ZEALAND to HELSINN in advance of the Effective Date hereof.

 

6.2.         Manufacture of Compound and Product.    Except as described at Article 6.1, ZEALAND shall have no obligation to supply HELSINN with Compound or Product and HELSINN shall be solely responsible to procure and manufacture, directly or through Affiliates or third parties, the necessary quantities of Compound and Product and Combination Product for development, commercial or any other purposes.

 

7.             PAYMENTS TO ZEALAND

 

7.1.         Licensing Fees.   As consideration for the licenses granted pursuant to this Agreement, HELSINN shall pay to ZEALAND a maximum licensing fee of €10,000,000 (ten million Euros)in the following four installments:

 

7.1.1.      [***] shall be paid no later than [***] days following the Effective Date hereof, being however understood that the amount of [***], which has already been paid by HELSINN in accordance with Article 3 of the Letter of Intent mentioned at preamble (vi) here above, shall be deducted from this first installment so that the effective amount to be paid by HELSINN to ZEALAND under this Article 7.1.1 is [***];

 

7.1.2.      [***] shall be paid no later than [***] days following the first anniversary of the Effective Date hereof, on condition that this Agreement is still in force at that time;

 

7.1.3.      € 500,000 (five hundred thousand Euros) shall be paid no later than [***] days following the second anniversary of the Effective Date, on condition that this Agreement is still in force at that time;

 

7.1.4.      [***] shall be paid no later than [***] days following the third anniversary of the Effective Date, on condition that this Agreement is still in force at that time.

 

7.2.         Milestone Payments.         HELSINN shall make milestone payments to ZEALAND up to a maximum [***] upon the occurrence of certain events, set forth as follows:

 

7.2.1.      [***] upon issuance of the ZEALAND Patent corresponding to the application [***];

 

7.2.2.      € 2,000,000 (two million Euros) upon the earlier of (i) December 31, 2011 or (ii) [***];

 

7.2.3.      € 1,000,000 (one million Euros) upon the earlier of (i) thirty-nine (39) months from the Effective Date or (ii) confirmation by HELSINN of [***];

 

7.2.4.      € 2,000,000 (two million Euros) upon the earlier of (i) September 30, 2014 or (ii) [***];

 

7.2.5.      [***] upon [***];

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

19

 

7.2.6.      [***] upon the earlier of [***];

 

7.2.7.      [***] upon the [***];

 

7.2.8.      [***] upon the [***];

 

7.2.9.      [***] upon the [***];

 

7.2.10.    [***] upon the [***].

 

All milestone payments set forth in this Article 7.2 shall be paid by HELSINN no later than [***] days following the relevant date or the occurrence of the relevant event. No part of a milestone payment shall be refundable.

 

Each of the milestone payments set forth in this Article 7.2 shall be paid only once, i.e. with respect to a Product or a Combination Product as the case may be.

 

In the event that, [***], the dates indicated at Articles 7.2.2(i), 7.2.4(i) and 7.2.6 (i) shall be postponed by the period of time needed to [***] the Compound, but in any case by no more than [***] months.

 

7.3.         Commercial Success Milestone Payments.  HELSINN shall also make commercial success milestone payments to ZEALAND up to a maximum [***].  These payments are calculated on a Calendar Year basis as follows:

 

7.3.1.      [***] upon accumulated worldwide annual Net Sales for the first time being equal to or greater than [***] in any Calendar Year throughout the Term;

 

7.3.2.      [***] upon accumulated worldwide annual Net Sales for the first time being equal to or greater than [***] in any Calendar Year throughout the Term;

 

7.3.3.      [***] upon accumulated worldwide annual Net Sales for the first time being equal to or greater than [***] in any Calendar Year throughout the Term;

 

7.3.4.      [***] upon accumulated worldwide annual Net Sales for the first time being equal to or greater than [***] in any Calendar Year throughout the Term.

 

All milestone payments provided in this Article 7.3 shall be paid by HELSINN no later than sixty (60) days of the end of the Calendar Year to which they refer. The Parties acknowledge that more than one Net Sales threshold may be achieved in a Calendar Year and if more than one Net Sales threshold shall be achieved, then multiple commercial success milestone payments shall be due. No part of a commercial success milestone payment shall be refundable.

 

The amount of accumulated worldwide annual Net Sales for the purpose of this Article 7.3 shall be calculated as follows: annual Net Sales in the currency of each country of the Territory shall be converted to Euro at the end of each Calendar Year on the basis of the average

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

20

 

of the exchange rates between the local currency and Euro published on the Financial Times of June 30th and December 31 of each year, and then aggregated on a worldwide basis to obtain the accumulates worldwide annual Net Sales in Euros.

 

7.4.         Royalties.

 

7.4.1.      Patent Countries.                HELSINN shall pay to ZEALAND a royalty of [***] on Net Sales of the Products in all Patent Countries. Said royalty shall be paid on a country-by-country basis for only so long as the country remains a Patent Country.

 

7.4.2.      Non-Patent Countries.        HELSINN shall pay to ZEALAND a royalty of [***] on Net Sales of the Products in all Non-Patent Countries, on a country-by-country basis for a period of ten (10) years from the First Launch of a Product in such Non-Patent Country; provided, however, that if such country was a Patent Country at the time of First Launch in such country but at any time thereafter becomes a Non-Patent Country, then HELSINN shall pay to ZEALAND such [***] royalty with respect to Net Sales in such country for a period of time that, when combined with the period of time for which such country had been a Patent Country, [***].

 

7.4.3.      Combination Products.     HELSINN shall pay to ZEALAND royalties on Net Sales of Combination Products at rates corresponding to a percentage of the royalty rates indicated at Article 7.4.1 and 7.4.2, to be negotiated and determined in good faith between the Parties based on a reasonable value to be attributed to the other active pharmaceutical ingredient, provided however that, if the Parties are unable to agree on such a determination within sixty (60) days of written submission of the matter by one Party to the other, then said percentage shall be finally determined by a Third Party independent expert to be appointed in accordance with the provisions of Exhibit 8.

 

7.4.4.      Sales to Third Parties.      No royalties shall accrue on the sales of HELSINN to HELSINN’s Affiliates or sub-licensees of HELSINN or on any transactions between such entities. Royalties shall accrue only on Net Sales of the Product by HELSINN, its Affiliates, or sub-licensees of HELSINN to non-Affiliated or non-sublicensed Third Parties.

 

7.4.5.      Payment and Reports.       HELSINN shall pay to ZEALAND the royalties due hereunder on a six-month basis, within sixty (60) days after the end of each calendar semester. The royalties shall be paid to ZEALAND in Euro, and HELSINN shall submit to ZEALAND, together with each royalty payment, a written royalty statement containing relevant information relating to sales of the Product in the Territory, including number of units, applicable exchange rates and the calculation of royalties payable hereunder by Product and by country. All royalties and other amounts, which are overdue under this Agreement, shall bear interest from and including the date due to but excluding the date of payment at a rate equal to the “Euribor three months” applicable on the date the payment was due.

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

21

 

7.4.6.      Conversion to Euros.        For the purposes of this Article 7.4, monthly Net Sales in the currency of the country of sale will be converted to Euros based on the average of the daily rate of exchange of the fifteenth and of the last day of the corresponding month as published in the Financial Times, or a comparable publication if it ceases to publish, and then aggregated in Euro for the six-month period.

 

7.5.         Records and Audit.

 

7.5.1.      During the Term and for a period of at least three (3) years thereafter, HELSINN shall keep, and shall cause its Affiliates to keep, complete, true and accurate records pertaining to the Net Sales for the purpose of showing the derivation of all milestone fees and royalties payable hereunder.

 

7.5.2.      ZEALAND shall have the right to cause a certified public accountant firm reasonably acceptable to HELSINN to audit accounts and records of HELSINN and/or its Affiliates which are directly relevant to the calculation of the amount of any payment due by HELSINN to ZEALAND under this Agreement during the Term and for a period of three (3) years thereafter. Any information obtained during such audit shall be treated as confidential information and any such accountant firm shall enter into appropriate confidentiality agreement with HELSINN in advance of any examination. A full copy of the audit report shall be promptly delivered by ZEALAND to HELSINN. Such audits may be exercised during normal business hours no more than once a year upon at least thirty (30) days’ prior written notice to HELSINN. ZEALAND shall bear the full cost of any such audit unless such audit reveals an underpayment of more than [***] due by HELSINN to ZEALAND for such audited period. In such case, HELSINN shall bear the full cost of such audit.

 

7.5.3.      HELSINN shall pay to ZEALAND any underpaid royalties within thirty days (30) of the date ZEALAND delivers to HELSINN such accountant’s written report so concluding. If such examination reveals that there has been an overpayment with respect to such amounts, the excess shall be credited to HELSINN against future payments to ZEALAND or shall be paid by ZEALAND to HELSINN within thirty (30) days of the date that ZEALAND delivers such report to HELSINN in case no further payments to ZEALAND are due. In the case, however, that the Parties are not in agreement about the results of the audit report, the issue shall be resolved by a Third Party independent expert appointed in accordance with the provisions of Exhibit 8.

 

7.5.4.      The terms of this Article 7.5 shall survive any termination or expiration of this Agreement for a period of three (3) years.

 

7.6.         Payment Instructions.       All payments to be made by HELSINN to ZEALAND under this Agreement shall be made by wire transfer from HELSINN to such ZEALAND account as shall be indicated in due time by ZEALAND.

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

22

 

8.             PROSECUTION, MAINTENANCE AND ENFORCEMENT OF ZEALAND PATENTS

 

8.1.         ZEALAND Responsibility.              Except in the case described at Article 8.3 below, at its sole costs and expenses ZEALAND shall diligently prepare, file, prosecute and maintain all of the ZEALAND Patents, including conducting any interferences, reexaminations, reissues, opposition proceedings, or request for patent term extension relating thereto. ZEALAND shall provide HELSINN with a revised Exhibit 5 updating the status of the ZEALAND Patents on an annual basis or more frequently if reasonably requested by HELSINN.

 

8.2.         Cooperation by HELSINN.             At ZEALAND’s request, HELSINN shall reasonably cooperate with ZEALAND in the preparation, filing, maintenance, prosecution and extension of the ZEALAND Patents. ZEALAND shall give HELSINN the opportunity to discuss and comment on the matter, it being understood that ZEALAND shall have the right to ultimately decide on all steps to be taken in connection with, and have sole responsibility for, the steps to be taken to maintain, prosecute or extend the ZEALAND Patents.

 

8.3.         Discontinuation of Prosecution or Maintenance of the ZEALAND Patents. If ZEALAND decides to no longer prosecute or maintain one or more ZEALAND Patents, then ZEALAND shall promptly advise HELSINN in writing thereof and HELSINN shall have the right, but not the obligation, to prosecute and maintain or defend such ZEALAND Patents at HELSINN’s expense, provided however that all reasonable costs and expenses borne by HELSINN in connection with prosecution and/or maintenance of any ZEALAND Patents shall be offset against future payments to be made by HELSINN to ZEALAND under this Agreement.

 

8.4.         Challenge By HELSINN. HELSINN may not challenge the validity or enforceability of any ZEALAND Patent without first giving ZEALAND fifteen (15) days advance written notice prior to initiating any such challenge. Such notice shall include a summary of all information known to HELSINN that is relevant to such a challenge.

 

8.5.         Third Party Infringement.              Each Party shall immediately notify the other Party in writing upon its becoming aware of any actions that may amount to threatened or alleged infringement by a Third Party in the Licensed Field of a claim in a ZEALAND Patent covering the Compound or the use of the Compound in the Licensed Field and, immediately following such notification, the Parties shall confer.

 

8.5.1.      ZEALAND Action.             If ZEALAND elects to take action against the Third Party infringer, then HELSINN shall render all reasonable assistance required to institute and carry on the proceedings, including if required, being joined as a necessary party, and shall in any case have the right to be represented by its own counsel at its cost and expense.

 

If awards of damages, accounts of profits and/or costs are made in ZEALAND’s and/or HELSINN’s favour, then each of ZEALAND and HELSINN shall each be entitled to recover from such amounts their reasonable costs and disbursements incurred in connection with the proceedings. If damages and/or an account of profits are ordered in such proceedings and relate to damage suffered by HELSINN as a result of such Third Party infringement, then HELSINN shall be entitled to those damages and/or account of profits. Similarly, if damages and/or an account of profits are ordered in such proceedings and relate to damage suffered by ZEALAND as a result of such Third Party infringement, then ZEALAND shall be entitled to those damages

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

23

 

and/or account of profits. Any other damages or account of profits awarded generally will be divided equally between the Parties.

 

No settlement of any such action or defense that restricts the scope or affects the enforceability of a claim in a ZEALAND Patent covering the Compound or the use of the Compound in the Licensed Field may be entered into by ZEALAND without the prior consent of HELSINN, which consent shall not be unreasonably withheld.

 

8.5.2.      HELSINN Action.              If ZEALAND elects not to take action against the Third Party infringer within thirty (30) days after ZEALAND has become aware of said infringement, then HELSINN shall be entitled to bring action for infringement in its own name and at its own expense. ZEALAND shall render all reasonable assistance required to institute and carry on the proceedings, including but not limited to executing any necessary document as may be required by law in order for HELSINN to bring such action and including, if required, being joined as a necessary party, and shall in any case have the right to be represented by its own counsel at its cost and expense.

 

If awards of damages, accounts of profits and/or costs are made in ZEALAND’s and/or HELSINN’s favour, then each of ZEALAND and HELSINN shall each be entitled to recover from such amounts their reasonable costs and disbursements incurred in connection with the proceedings. If damages and/or an account of profits are ordered in such proceedings and relate to damage suffered by HELSINN as a result of such Third Party infringement, then HELSINN shall be entitled to those damages and/or account of profits. Similarly, if damages and/or an account of profits are ordered in such proceedings and relate to damage suffered by ZEALAND as a result of such Third Party infringement, then ZEALAND shall be entitled to those damages and/or account of profits. Any other damages or account of profits awarded generally will be divided equally between the Parties. In addition to the above, HELSINN shall have the right to offset all costs and expenses incurred in connection with the proceedings against future payments to be made by HELSINN to ZEALAND under this Agreement. No settlement of any such action or defense that restricts the scope or affects the enforceability of a ZEALAND Patent may be entered into by HELS INN without the prior consent of ZEALAND.

 

8.6.         Infringement by Compound or Product.     In the event of any notice or claim that the use, manufacture or sale of the Compound and/or a Product or Combination Product in any country of the Territory infringes any Issued Patent Claim in a Third Party’s Patent or other Intellectual Property of a Third Party, or in the event of commencement of any suit or action for infringement of any right claimed by a Third Party, then the Parties agree as follows:

 

8.6.1.      Each Party shall promptly inform the other in writing;

 

8.6.2.      HELSINN shall have the sole obligation to defend any such suit or action and Parties shall cooperate in the defense of such suit or action, each bearing its own expenses;

 

8.6.3.      Neither ZEALAND nor HELSINN shall take a position, including defense, settlement or compromise of any such suit or action without the consent of the other Party,

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

24

 

which consent shall not be unreasonably withheld, if the position, including defenses or settlement or compromise obliges the other Party to make any payment or in any way restricts the scope or affects the enforceability of ZEALAND Patents;

 

8.6.4.      The right to initiate, prosecute and settle any counter claim action relating to the ZEALAND Patents shall be governed by Article 8.5 above;

 

8.6.5.      If necessary in order to avoid infringement of said Third Party Patent having a claim covering the Compound or the use of the Compound in the Licensed Field which would result from sales of a Product or Combination Product, HELSINN and ZEALAND shall use Commercially Reasonable Efforts to obtain a license for HELSINN under the Third Party’s Patents. If HELSINN obtains such a license, royalties to be paid by HELSINN to ZEALAND hereunder shall continue to be payable in accordance with the terms and conditions of this Agreement and any royalties on sales of the Product or Combination Product payable to the Third Party under said license shall be paid by HELS INN. HELSINN shall have the right to offset any and all payments made to any Third Parties under this Article 8.6.5 against the royalties payable by HELSINN to ZEALAND for Net Sales in the Territory under this Agreement, provided however that in no event such offset shall reduce the royalties payable to ZEALAND hereunder to [***].

 

HELSINN shall in any event have the right to offset all costs and expenses incurred in connection with any suit or action by a Third Party that claims that the use, manufacture or sale of the Compound and/or Product or Combination Product infringes any Issued Patent Claim in a Third Party’s Patent covering the Compound or the use of the Compound in the Licensed Field against future payments to be made by HELSINN to ZEALAND under this Agreement.

 

In the event that, as a consequence of the Third Party’s action hereunder, First Launch has to be delayed in any country or countries of the Territory, then no royalty shall be payable to ZEALAND on Net Sales achieved, in any said country or countries, during a period starting from First Launch and equal to the period elapsed from the day First Launch was expected and the day said First Launch occurred.

 

8.7.         Patent Term Extension.    HELSINN and ZEALAND shall cooperate throughout the Territory in filing for and obtaining patent term extensions and supplementary or complementary protection certificates, if available, in respect of the ZEALAND Patents. Such cooperation shall include, without limitation: (i) advising each other in a timely manner of any action by any regulatory or other competent authority that is pertinent to any such extension; (ii) reasonably supplying each other with all information in its control pertaining to the extension of any such ZEALAND Patent; and (iii) co-operating with each other to prepare and execute all supporting documents required in connection with the extension of any such ZEALAND Patent, (iv) keeping the other Party timely informed and updated on the relevant procedures.

 

8.8.         HELSINN Patents.             ZEALAND shall cooperate with HELSINN throughout the Territory in HELSINN’s filing for and obtaining Patents, Patent term extensions and supplementary or complementary protection certificates, if available, of inventions forming part of Intellectual Property owned by HELSINN that relates to the subject matter of this Agreement.

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

25

 

Such cooperation shall include, without limitation: (i) advising each other in a timely manner of any action by any regulatory or other competent authority that is pertinent to any such Patent or other application; (ii) reasonably supplying each other with all information in its control pertaining to such Patent or other application; and (iii) co-operating with each other to prepare and execute all supporting documents required in connection with such Patent or other application, (iv) keeping the other Party timely informed and updated on the relevant procedures.

 

9.             REPRESENTATIONS AND WARRANTIES

 

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

 

9.1.1.      It is a corporation duly organized and validly existing under the law of the jurisdiction in which it is incorporated;

 

9.1.2.      It has the corporate and legal right, title, power and authority to enter into this Agreement and to carry out the provisions hereof;

 

9.1.3.      It has all necessary corporate and any other approvals for execution, delivery and performance of this Agreement;

 

9.1.4.      Upon execution and delivery, this Agreement shall constitute a valid and binding obligation of it, enforceable in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ and contracting parties’ rights generally and except as enforceability may be subject to general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at law), to the extent that these laws cannot be and are not contracted out by the terms of this Agreement;

 

9.1.5.      The execution, delivery and performance of this Agreement will not conflict in any way with the terms of any other agreement or instrument to which it is or becomes a party or by which it is or becomes bound, nor violate any law or regulation or decision of any court, governmental body or administrative or other agency having authority over it;

 

9.1.6.      The persons executing this Agreement on its behalf are duly authorized to do so and by so doing have bound such Party to the terms and conditions of this Agreement; and

 

9.1.7.      There is no action, suit, investigation or proceeding pending against, or to its knowledge, threatened against or affecting it before any court, arbitrator or any governmental authority, including but not limited to regulatory authorities, that in any manner challenges or seeks to prevent, enjoin, alter or materially delay the contemplated transactions, and, to its knowledge, there is no reasonably valid basis for any such action, suit investigation or proceeding to be brought.

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

26

 

9.2.         Further Representations and Warranties of ZEALAND. ZEALAND hereby represents and warrants to HELSINN as follows:

 

9.2.1.      ZEALAND has the full right and power to grant the licenses set forth in Article 2 in the manner, for the duration of and to the extent set forth in this Agreement, free and clear of any adverse assignment, grant, restriction on use or other Encumbrances inconsistent with such grant.

 

9.2.2.      The ZEALAND Patents and ZEALAND Know-How are not subject to liens, mortgages, security interests or otherwise and ZEALAND will not in the future specifically encumber any ZEALAND Patents or ZEALAND Know-How in any manner that would adversely affect the licenses granted hereunder.

 

9.2.3.      All GMP-grade materials listed in Exhibit 6 hereto have been manufactured in full compliance with all applicable laws and regulations, including but not limited to current GMP as set out in Eudralex Volume 4 and with relevant EU and national laws and guidances and will be delivered to HELSINN accompanied by certificates of analysis compliant with all relevant applicable laws and regulations.

 

9.2.4.      (i) There are no contracts, agreements or understandings to which ZEALAND is a Party, other than the Existing Agreements, which would have a materially adverse effect on, or which materially relate to, the subject matter of this Agreement and/or the licenses granted by ZEALAND to HELSINN hereunder; (ii) All Existing Agreements have been terminated or expired in advance of the Effective Date hereof and are no longer valid or in effect, with the exception of those identified in sections B1 and B2 of Exhibit 2 attached hereto, which will remain in full force and effect until, if applicable, the execution of appropriate replacing agreements by HELSINN with (a) the Third Parties who will test said materials or (b) the sites where said materials will be stored, as the case may be; (iii) ZEALAND has complied with any and all of its obligations, representations and warranties under the Existing Agreements and it has not received, and does not expect to receive, any notice of claim or breach of any said Existing Agreement.

 

9.2.5.

 

(i)            ZEALAND is the sole and exclusive legal and beneficial owner of the entire right, title and interest in and to the ZEALAND Know-How and the ZEALAND Patents and any connected Intellectual Property;

 

(ii)           as of the Effective Date, all ZEALAND Patents have been duly maintained;

 

(iii)          as of the Effective Date, none of the Patents set forth in Exhibit 5 hereto (i) is subject to a pending interference action, opposition action, litigation or other similar action by a Third Party challenging such Patents or Patent applications, other than actions by competent Patent authorities in connection with the prosecution of Patent applications, or (ii) has been abandoned, or has been

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

27

 

asserted to be invalid or unenforceable in a communication to ZEALAND or is subject to any inventorship proceeding or dispute;

 

(iv)          to the best of ZEALAND’s knowledge formed after diligent inquiry, the Compound has not been publicly disclosed or described in a publication or disclosure that constitutes prior art under the patent laws of any Major Market before May 4th, 2005;

 

(v)           the inventors named on the ZEALAND Patents are the correct inventors of the subject matter disclosed and claimed therein under the patent laws of any Major Market;

 

(vi)          as of the Effective Date, to the best of its knowledge formed after diligent inquiry, the ZEALAND Patents and ZEALAND Know-How are not, and have not been, the subject of any unauthorized use, infringement or misappropriation by a Third Party;

 

(vii)         as of the Effective Date, ZEALAND has not received any written notice or other written communication alleging that the Compound infringes or misappropriates the Know-How, Patents and/or Intellectual Property of a Third Party;

 

(viii)        the manufacture, use and/or sale of Compound and/or Product in the Licensed Field in the Territory does not and will not infringe any Third Party Patent granted as of the Effective Date in any country within the Territory and that is scheduled to expire after April 15, 2015 (or February 26, 2016 with respect to US Patent No. 7,049,284);

 

(ix)          to the best of its knowledge formed after diligent inquiry, each of the Patents in the ZEALAND Patents is without any defect and/or lack of patentability requirements that would preclude its enforcement if eventually granted, and there is no prior art that would render invalid a Patent claim that issues from any of the national stage applications of ZEALAND Patents.

 

9.2.6.      All ZEALAND Know-How existing at the Effective Date has been made available to HELSINN or will be made available to HELSINN within the Transfer Period and such ZEALAND Know-How is accurate and complete.

 

9.2.7.      All confidential information relating to the ZEALAND Know-How, the ZEALAND Patents and ZEALAND Intellectual Property has not been disclosed to any Third Party other than under the confidentiality agreements included in Exhibit 2 attached to this Agreement.

 

9.2.8.      To the best of ZEALAND knowledge formed after diligent enquiry, all raw data supporting the ZEALAND Know-How are available and in good order in the relevant laboratories and manufacturing plants.

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

28

 

9.2.9.      (i) None of the materials and documents provided to HELSINN in the course of the due diligence preceding execution of this Agreement contained any untrue statement of material fact; (ii) as of the Effective Date, ZEALAND has informed HELSINN of any pre-clinical or clinical data or information concerning the Compound which reasonably suggests that there may exist quality, toxicity, safety and/or efficacy concerns which may materially impair the safety of the Compound.

 

9.3.         Disclaimer.          THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS ARTICLE 9 ARE THE SOLE REPRESENTATIONS AND WARRANTIES MADE BY EITHER PARTY TO THE OTHER AND THERE ARE NO OTHER WARRANTIES, REPRESENTATIONS OR GUARANTEES OF ANY KIND WHATSOEVER, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE WITH RESPECT TO THE COMPOUND OR PRODUCT, OR THAT A PRODUCT CAN BE DEVELOPED FROM THE ZEALAND KNOW-HOW. NO ORAL OR WRITTEN REPRESENTATION BY OR ON BEHALF OF EITHER PARTY SHALL BE INTERPRETED TO CONTAIN ANY SUCH WARRANTY. NEITHER PARTY IS AUTHORISED TO GIVE ANY WARRANTIES OR MAKE ANY REPRESENTATION ON BEHALF OF THE OTHER PARTY.

 

10.          INDEMNIFICATION

 

10.1.       By HELSINN.     HELSINN shall defend, indemnify and hold harmless ZEALAND, its Affiliates, its sub licensees, and their respective directors, officers and employees (each a “ZEALAND Indemnitee”) from and against any and all liabilities, damages, losses, costs and/or expenses, direct or indirect (including attorneys’ and professional fees and other expenses of litigation, arbitration or investigation) (“Liabilities”) resulting from any claim, suit or proceeding made or brought by any Third Party for personal injury or property damage against a ZEALAND Indemnitee to the extent arising from or occurring as a result of: (i) any use, manufacture, development, distribution, storage, handling, promotion, marketing and/or sale of the Compound and/or Product and/or Combination Product by or for HELSINN or its Affiliates or sub-licensees after the Effective Date, (ii) the use of any Product and/or Combination Product after the Effective Date by any person or entity, and/or (iii) any breach by HELSINN of any of its obligations hereunder; except in each case to the extent that (1) any such Liability was due to the gross negligence or willful misconduct or default of a ZEALAND Indemnitee or (2) ZEALAND has an obligation under Article 10.2 to indemnify HELSINN for such Liabilities.

 

10.2.       By ZEALAND.    ZEALAND shall defend, indemnify and hold harmless HELSINN, its Affiliates, its sub-licensees, and their respective directors, officers and employees (each a “HELSINN Indemnitee”) from and against any and all Liabilities resulting from any claim, suit or proceeding made or brought by any Third Party for personal injury or property damage against a HELSINN Indemnitee to the extent arising from or occurring as a result of: (i) any breach by ZEALAND of any of the representations and warranties set forth in Article 9.2, (ii) any breach by ZEALAND of any of its obligations hereunder; except in each case to the extent that (1) any such Liability was due to the gross negligence or willful misconduct or default of a HELSINN Indemnitee or (2) HELSINN has an obligation under Article 10.1 to indemnify ZEALAND for such Liabilities.

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

29

 

10.3.       Procedure.           A Party seeking indemnification hereunder (an “Indemnitee”) shall give prompt written notice to the Party from whom such indemnification is sought (the “Indemnitor”) of such alleged Liability or the commencement of any action, suit or proceeding, in respect of which indemnity is or may be sought hereunder and will give the Indemnitor such information with respect thereto as the Indemnitor may reasonably request, being understood that no failure to give such information shall relieve the Indemnitor of any Liability hereunder (except to the extent the Indemnitor has suffered actual prejudice thereby). Except as otherwise provided in Article 8.5 or 8.6, if applicable, the Indemnitor shall have the sole right to control the defense and management of any such action, suit or proceeding, including settlements. The Indemnitee shall fully cooperate with the Indemnitor and shall have the right to participate in the defense thereof, and to employ counsel, at its own expense, separate from counsel employed by the Indemnitor in any such action. The Indemnitee shall not make any payment, incur any expense or make any admissions with respect to any claim or suit without the prior written consent of the Indemnitor, which the Indemnitor shall not be required to give. The Indemnitor shall not be required to provide indemnification with respect to a Liability the defense of which is actually prejudiced by the failure to give notice by the Indemnitee or the failure of the Indemnitee to cooperate with the Indemnitor or where the Indemnitee makes any admissions or settles or compromises a Liability without the written consent of the Indemnitor. Each Party shall cooperate with the other Party in resolving any claim or Liability with respect to which one Party is obligated to indemnify the other under this Agreement, including without limitation, by making Commercially Reasonable Efforts to mitigate or resolve any such claim or Liability.

 

10.4.       Limitation.           Except as set out in Articles 10.1 and 10.2 neither Party shall be liable to the other for loss of profit or use or for any incidental, consequential, indirect, special or punitive damages in any claim asserted by the other Party relating to this Agreement.

 

11.          CONFIDENTIALITY

 

11.1.       Obligation of Confidentiality.        Each of the Parties shall keep in confidence and shall not use or disclose, other than as provided hereunder, this Agreement and any and all information, data, documents or materials received from the other Party or in any way related to the subject matter of this Agreement (the “Confidential Information”). Said confidentiality and non-use obligation shall remain in force indefinitely and will survive expiration or termination of this Agreement.

 

11.2.       Exceptions.          The obligation of confidentiality and non-use set forth in this Article 11 shall not apply to any information, data, document or material that:

 

11.2.1.    at the time of disclosure, was known by the recipient Party or an Affiliate or sub-licensee, or which after disclosure was independently developed by the recipient Party, an Affiliate or a sub-licensee without use of such information, data, document or material, and which can be so demonstrated by the written records of the recipient Party, Affiliate or sub-licensee, as the case may be; and/or

 

11.2.2.    is public knowledge at the date of disclosure to the recipient Party; and/or

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

30

 

11.2.3.    becomes public knowledge at a later date without any fault of the recipient Party, Affiliate or a sub-licensee; and/or

 

11.2.4.    is disclosed to the recipient Party, an Affiliate or sub-licensee by a Third Party under no obligation of confidentiality or non-use to the disclosing Party; and/or

 

11.2.5.    is required to be disclosed for the purpose of regulatory submissions relevant to the Compound or the Product or Combination Product by HELSINN, its Affiliates and/or sub-licensees,

 

11.2.6.    is required to be disclosed for the purpose of filing or prosecuting any Patent applications relating to the Compound or the Product or Combination Product by HELSINN and/or by ZEALAND; and/or

 

11.2.7.    is required to comply with any law, rule or regulation or any subpoena, order or directive of any court or governmental agency or body.

 

11.3.       Authorized Disclosure.     Notwithstanding the above provisions, HELSINN has the right to disclose Confidential Information hereunder in connection with the performance of this Agreement and/or in furtherance of the rights granted to it hereunder, to Affiliates, partners, sub-licensees, collaborators, employees, consultants, or agents, each of whom prior to disclosure must be bound by obligations of confidentiality and non-use no less onerous than those set forth in this Article 11 with the exception that it must have a duration of no less than five (5) years from the date of disclosure.

 

11.4.       Publications. Notwithstanding any other provision of this Agreement, HELSINN shall at all time be free to make publications or presentations with regard to the Compound and/or the Product, as it shall deem appropriate for the effective management of the development and commercialization of the Product throughout the Territory. HELSINN shall provide ZEALAND every six (6) months throughout the Term with a copy of said publications or presentations for ZEALAND information, provided, however, that in no event shall HELSINN publish Confidential Information of ZEALAND relating to (i) marketing, financing or business developments, opportunities, plans, methods, processes or procedures, (ii) quality controls, (iii) security controls, (iv) unpublished cost price or pricing information, (v) financial or personnel matters, or (vi) customer, client or supplier lists or information, in each case without the prior written approval of ZEALAND.

 

12.          TERM AND TERMINATION

 

12.1.       Effective Date and Duration.          This Agreement comes into force on the Effective Date and unless terminated earlier, shall expire on the date on which ZEALAND is no longer entitled to receive a royalty from HELSINN on the sales of any Product or Combination Product pursuant to Article 7.4 of this Agreement (the “Term”). After expiration, the licenses granted under this Agreement will be converted to a fully paid and royalty free worldwide exclusive license not requiring any further payments by HELSINN.

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

31

 

12.2.       Termination For Material Breach.  If either Party commits a material breach of any of its respective covenants or obligations in this Agreement, and such default is not remedied within sixty (60) days after receiving written notice from the other Party with respect to such default, such other Party shall have the right to terminate this Agreement with immediate effect by giving thirty (30) days advance written notice to the Party in default. The right of either Party to terminate this Agreement as provided hereinabove shall not be affected in any way by its waiver of or failure to take actions with respect to any previous breach.

 

12.2.1.    (i) in the event of a material breach by ZEALAND, then as an alternative to its right to terminate this Agreement as described above and at Article 13.2 below, HELSINN may in its discretion elect to continue this Agreement and to reduce the royalty rates payable to ZEALAND for the remaining term of this Agreement to a percentage or percentages, as the case may be, to be negotiated and determined in good faith between the Parties, provided however that, if the Parties are unable to agree on such a determination within sixty (60) days of written submission of the matter by one Party to the other, then said percentage or percentages, as the case may be, shall be determined by a Third Party independent expert to be appointed in accordance with the provisions of Exhibit 8, provided further that in no case shall said reduced royalty rates, as agreed by the Parties or determined by the Third Party independent expert, be higher than [***] percent [***] of the royalty rates which would otherwise be applicable. (ii) In the case however that ZEALAND’s material breach compromises the ability of HELSINN to continue the exploitation of the Compound and/or Product, and HELSINN has no alternative but to terminate this Agreement, then in such case Helsinn shall receive from ZEALAND appropriate payments (as determined by arbitration pursuant to Article 14 below) to fully compensate HELSINN for any losses or damages suffered as a result of such material breach and termination of the Agreement.

 

12.2.2.    Notwithstanding anything in this Agreement to the contrary (including, in particular but without limitation, Article 15.9), in the event that HELSINN elects, despite a material breach by ZEALAND, to continue this Agreement pursuant to Article 12.2.1(i), HELSINN shall not be entitled to claim any remedy in relation to the material breach in question other than a reduction in the royalty rates payable to ZEALAND as agreed between the Parties or determined by a Third Party independent expert in accordance with Article 12.2.1(i) and such reduction in royalties shall be in full and final settlement of any claim that HELSINN might have in relation to such material breach.

 

12.3.       Discontinuation by HELSINN.       Notwithstanding any other provision of this Agreement, HELSINN shall at any time have the right to discontinue the development and/or commercialization of the Compound and/or Product or Combination Product and thereby relinquish all the rights and the licenses granted to it under this Agreement and terminate this Agreement by thirty (30) days advance written notice to ZEALAND, in the event that in HELSINN’s reasonable judgment after diligent consideration and consultation with ZEALAND, it is not reasonably viable for HELSINN to carry out further development and/or commercialization of said Compound and/or Product.

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

32

 

HELSINN shall also have the right to terminate this Agreement by thirty (30) days advance written notice to ZEALAND in the event that ZEALAND Patents having one or more compound (composition of matter) claims that cover (i) ZP1846 or (ii) its [***] in the event that HELSINN decides to develop and commercialize said [***] as a Designated Back-Up Compound in lieu of ZP1846, are not granted by the US Patent and Trademark Office by May 4th, 2016, or are revoked or the coverage granted does not include the Compound and/or such metabolites.

 

12.4.       Insolvency.           In the event that either of the Parties becomes insolvent or makes an assignment for the benefit of creditors or is the subject of receivership, bankruptcy or other insolvency or debtor relief proceedings, or any similar proceedings, that Party (the “Defaulting Party”) shall promptly notify the other Party in writing giving particulars of the circumstances. The other Party may then elect to terminate the Agreement with effect from the date of receipt of the notification from the Defaulting Party.

 

12.4.1.    To the extent permitted by applicable law, notwithstanding the insolvency or bankruptcy of ZEALAND, or the impairment of performance by ZEALAND of its obligations under this Agreement as a result of said insolvency or bankruptcy, HELS INN shall (provided that all payments due to ZEALAND from HELSINN hereunder have been made) be entitled to retain the licenses granted herein, subject to the provisions of this Agreement as regards expiration and ZEALAND’s rights to terminate this Agreement for reasons other than bankruptcy or insolvency as expressly provided in this Agreement.

 

13.          EFFECTS OF TERMINATION

 

13.1.       Termination attributable to HELSINN. If this Agreement is terminated by ZEALAND pursuant to Article 12.2 or 12.4 here above, or by HELSINN pursuant to Article 12.3 here above, then:

 

13.1.1.    all licenses granted by ZEALAND to HELSINN hereunder shall terminate from the date immediately following the effective date of termination and HELSINN shall no longer use any ZEALAND Know-How, ZEALAND Patents or ZEALAND Intellectual Property,

 

13.1.2.    HELSINN shall grant to ZEALAND, following ZEALAND written request, a royalty-free, worldwide semi-exclusive license with the right to sub-license under any HELSINN Know-How and HELSINN Patents Controlled by HELSINN that is exclusively related to the Compound and Product, at ZEALAND’s option and upon reimbursement by ZEALAND of the documented external costs and expenses incurred by HELSINN to develop, file and maintain said HELSINN Know-How and HELSINN Patents,

 

13.1.3.    HELSINN shall cooperate with ZEALAND, upon ZEALAND written request, to assign and transfer to ZEALAND (or a ZEALAND nominee) as soon as reasonably possible all regulatory filings, including Authority Approvals, in the name of HELSINN related to the Compound or any Product, upon reimbursement by ZEALAND

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

33

 

of all administrative costs and fees paid by HELSINN and other disbursements incurred by HELS INN in connection with such regulatory filings.

 

13.2.       Termination Attributable to ZEALAND. In the event that this Agreement is terminated by HELSINN pursuant to Article 12.2, then the consequences set forth at Article 12.2.1(ii) shall apply. In the event that this Agreement is terminated by HELSINN pursuant to Article 12.4, then the consequences set forth at Article 12.4.1 shall apply.

 

13.3.       Rights of HELSINN’s Sub-licensees Upon Termination. HELSINN’s sub-licensees’ rights on the Compound and the Product or Combination Product shall survive termination of this Agreement for any reason. HELSINN’s rights as sub-licensor shall be assigned by HELSINN to ZEALAND free of charge and shall become direct licenses from ZEALAND to the sub-licensees, provided however that (a) the relations between each said sub-licensee and ZEALAND shall be regulated either by the agreement in force between HELSINN and the sub-licensee or by any other mutually agreed contract which ZEALAND and the sub-licensee may deem appropriate, and (b) HELSINN undertakes, upon ZEALAND’s request, to manufacture and supply the Compound and/or the Product in accordance with ZEALAND’s and/or the sub-licensees’s reasonable requirements for a period and at a price to be reasonably agreed upon in good faith between the Parties. This clause shall not apply to any sub-licensee whose actions or omissions caused this Agreement to be terminated pursuant to Article 12.2.

 

13.4.       Additional Remedies.        Termination or expiration of this Agreement for any reason shall not release either Party hereto from any liability which, at the time of such termination or expiration, has already accrued to the other Party or which is attributable to a period prior to such termination or expiration, or preclude either Party from pursuing any and all rights and remedies it may have hereunder or at law or in equity with respect to any breach of, or default under, this Agreement.

 

14.          GOVERNING LAW AND SETTLEMENT OF DISPUTES

 

14.1.       Governing Law.     This Agreement shall be governed by and construed in accordance with the laws of England and Wales, without regard to the conflict of law rules thereof.

 

14.2.       Dispute Resolution Procedure.       Both Parties will endeavor to settle all matters in dispute amicably. With the exception of a dispute arising under Article 7.4.3, Article 7.5.3 or Article 12.2.1(i), any dispute arising out of or in connection with this Agreement including any question regarding its existence, validity or termination, shall be settled as far as possible by negotiations between the Parties. If the Parties are unable to resolve a dispute in an amicable way within fourteen (14) days of written submission of the dispute by one Party to the other Party, any Party may, by written notice to the other, have such dispute referred to their respective officers designated below or their successors, for resolution. Said designated officers are as follows:

 

For ZEALAND:    CEO or an executive officer designated by the CEO

 

For HELSINN:     CEO or an executive officer designated by the CEO

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

34

 

14.3.       Arbitration. If the designated officers of each Party are unable to resolve a dispute referred to them within thirty (30) days of the receipt of the written notice referred to in Article 14.2 above, the matter shall be referred to and finally resolved by arbitration under the LCIA Rules, which Rules are deemed to be incorporated by reference into this clause.

 

14.3.1.    The number of arbitrators shall be three.

 

14.3.2.    The seat, or legal place, of arbitration shall be London, England.

 

14.3.3.    The language to be used in the arbitral proceedings shall be English.

 

14.4.       Interim and Equitable Relief. Nothing in this Agreement prevents either Party instituting and prosecuting proceedings in any court of competent jurisdiction to seek interim or equitable relief of any type and the Parties consent to the non-exclusive jurisdiction of the courts of England and Wales to seek such relief.

 

15.          ADDITIONAL TERMS

 

15.1.       Entire Agreement and Amendments.            This Agreement contains the entire understanding between the Parties relating to the subject matter hereof and supersede any and all prior agreements, understandings and arrangements, whether written or oral, between the Parties. No amendments, changes, modifications or alterations of the terms and conditions of this Agreement shall be binding upon either Party unless in writing and signed by both parties.

 

15.2.       Construction of the Agreement.     Except where the context otherwise requires, wherever used, the singular will include the plural, the plural the singular, the use of any gender will be applicable to all genders, and the word “or” is used in the inclusive sense. When used in this Agreement, “including” means “including, without limitation,” and the word “days” refers to “working days” meaning days when banks are open for business in both Switzerland and Denmark. References to either Party include the successors and permitted assigns of that Party. The headings, titles and captions in 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. If the terms of this Agreement conflict with the terms of any Exhibit, then the terms of this Agreement shall govern. The official text of this Agreement and any Exhibits hereto is English, and any notice given or accounts or statements required by this Agreement, and any dispute proceeding related to or arising hereunder, shall be in English. In the event of any dispute concerning the construction or meaning of this Agreement, reference shall be made only to this Agreement as written in English and not to any other translation into any other language.

 

15.3.       Notices. Any notice or communication to be given in connection with the matters contemplated by this Agreement shall be in writing and shall either be sent by first class pre-paid post, delivered by courier or sent by fax, at the respective addresses and facsimile numbers set forth below or at such other address and facsimile number as either Party hereto may designate in writing. Any notice or communication shall be deemed to have been served (i) at the expiration of three days after the time of posting, if sent by first class pre-paid post or by courier, (ii) at the time of completion of transmission by the sender, if sent by telefax

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

35

 

if to HELSINN, to:

 

HELSINN Healthcare SA Via Pian Scairolo 9

6912 Pazzallo Lugano Switzerland

Attention: Legal Department

Fax 004191-9932122

and if to ZEALAND, to:

 

Smedeland 36

2600 Glostrup

Denmark

Attention: Mogens Vang Rasmussen

Phone: +45 4328 1200

Fax: +45 4328 1212

 

15.4.       Severability.        The Parties hereby expressly state that it is the intention of neither Party to violate any rule, law and regulations. If any of the provisions of this Agreement are held to be void or unenforceable, then such void or unenforceable provisions shall be replaced by valid and enforceable provisions negotiated in good faith by the Parties, which will achieve as far as possible the economic business intentions of the Parties.

 

15.5.       Independent Contractors. The relationship of the Parties hereto is that of independent contractors. The Parties hereto are not deemed to be agents, partners or joint venturers of the other for any purpose as a result of this Agreement or the transactions contemplated thereby. At no time shall any Party make commitments or incur any charges or expenses for or in the name of the other Party.

 

15.6.       Use of Names.      Except as may be required by law or for the purposes of this Agreement, neither Party shall use any name, trade name, trademarks or other designation of the other Party for any advertising, communication or promotional purposes without the prior written consent of such other Party.

 

15.7.       Assignment.         Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other, such consent not to be unreasonably withheld, provided however that a Party may make such an assignment without the other Party’s consent to an Affiliate or to a successor to substantially all of the business of such Party to which this Agreement relates, whether in a merger, sale of stock, sale of assets or other transaction, so long as such Affiliate, permitted successor or assignee of rights and/or obligations hereunder shall, in writing to the other Party, expressly assume performance of such rights and/or obligations.

 

This Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties. Any assignment or attempted assignment by either Party in violation of the terms of this Article 15.7 shall be null and void and of no legal effect.

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

36

 

15.8.       No Waiver.          The failure of either Party to enforce or require performance of any of the provisions of this Agreement; or to exercise any right herein provided, shall in no way be construed as a waiver of such provision or right or thereafter affect such Party’s right to enforce any provision of this Agreement, and no waiver by a Party of any of the provisions of this Agreement shall be deemed to have been made unless explicitly expressed in writing and signed by the waiving Party.

 

15.9.       Cumulative Rights.            The rights, powers and remedies hereunder shall be in addition to, and not in limitation of, all rights, powers and remedies provided at law or in equity. All of such rights, powers and remedies shall be cumulative, and may be exercised successively or cumulatively.

 

15.10.     Mitigation.           Each of the Parties hereto shall take commercially reasonable steps to avoid or mitigate any loss, damage or liability which might give rise to a claim under this Agreement.

 

15.11.     Insurance.            Each Party agrees to procure and maintain in full force and effect during the Term customary valid and collectible insurance policies in connection with its activities, obligations and responsibilities as contemplated herein. Within 5 (five) working days of the Effective Date and thereafter upon request of the other Party, each Party shall provide the other Party with a certificate evidencing the coverage required hereby and the amount thereof. Such coverage shall be with a reputable insurance company and shall have to be maintained for not less than ten (10) years following expiration or termination of this Agreement for any reason.

 

15.12.     Force Majeure.   Each Party shall be excused from the performance of its obligations (other than obligations for payments already due and owing) under this Agreement to the extent that such performance is prevented by force majeure and the non-performing Party promptly provides notice of the prevention to the other Party. Such excuse shall be continued so long as the condition constituting force majeure continues and the non-performing Party takes reasonable efforts to overcome the condition. For purposes of this Agreement, force majeure shall include conditions beyond the control of the Parties, including without limitation, an act of God, voluntary or involuntary compliance with any regulation, law or order of any government, war, act of terrorism, civil commotion, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe; provided, however, the payment of invoices due and owing hereunder shall not be delayed by the payer because of a force majeure affecting the payer.

 

15.13.     Announcements. Each Party shall be entitled to issue a press release upon execution of this Agreement, which shall have to be approved by both Parties in advance of publication. If ZEALAND desires to make any subsequent public announcement or press release concerning the terms of this Agreement or the activities hereunder, ZEALAND shall give reasonable advance notice of the proposed text of such announcement to HELSINN for its review and approval prior to announcement, such approval shall not be unreasonably delayed or withheld. HELSINN shall provide its comments, if any, within three (3) days after receipt of the proposed text and ZEALAND shall reasonably consider and address such comments. Notwithstanding

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

37

 

anything to the contrary, such approval shall not be needed if such public announcement solely discloses information that has previously been approved for disclosure by HELSINN.

 

15.14.     Contracts (Rights of Third Parties) Act 1999.

 

15.14.1. HELSINN’s sub-licensees as permitted by Article 2.1 and set out in Article 13.3 may enforce or enjoy the benefit of the provisions of Article 13.3 and the provisions of the Contracts (Rights of Third Parties) Act 1999.

 

15.14.2. Except as provided in Article 15.14.1, a person who is not a party to this Agreement has no right under the Contracts (Rights of Third Parties) Act 1999 to enforce or enjoy the benefit of any provision of this Agreement but this does not affect any right or remedy of a Third Party which exists or is available apart from that Act. Notwithstanding any other term of this Agreement, the consent of any person who is not a party to this Agreement is not required to rescind or vary this Agreement at any time.

 

15.15.     Data Protection. The Parties will comply with their obligations under any applicable laws relating to the collection, use, processing, protection or disclosure of data relating to individuals or corporations, including personal data, in the course of the Parties carrying out their obligations under this Agreement. This includes EU Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data, and any legislation implementing such article, and any legislation implementing the same in the relevant state (collectively, “Data Protection Laws”). Each Party will not perform, or refrain from performing, any act that puts the other in breach under the Data Protection Laws, and nothing in this Agreement shall be deemed to prevent the Parties from taking steps it reasonably deems necessary to comply with the Data Protection Laws.

 

15.15.1. Without prejudice to the provisions of Article 15.16, each Party will take all necessary steps to ensure that all personal data, which is made available to it for the purpose of, or in connection with the performance of its obligations under this Agreement is protected and used in accordance with applicable Requirements of Law.

 

15.15.2. Each Party acknowledges that in performing its obligations under this Agreement, it may process “personal data” within the meaning of the Data Protection Laws. In such circumstances:

 

(i)            Each Party will process such personal data only on and subject to the instructions of the other Party, the processing of personal data which is reasonably required for the purpose of that first Party performing its obligations under or contemplated by this Agreement, shall constitute processing in accordance with the instructions of the other Party; and

 

(ii)           Each Party undertakes that it will implement appropriate technical and organizational security measures as are necessary to comply with the security obligations of the Data Protection Laws.

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

38

 

15.15.3. “Requirements of Law” means any foreign, federal state or local laws, statutes, regulations, rules, codes or ordinances enacted, adopted, issued or promulgated by any court or government body or common law or any consent decree or settlement agreement entered into with any government body, including any Data Protection Laws.

 

15.16.     Survival.      The provisions of Articles 1, 7.5, 10, 11, 12, 13, 14 and 15 shall survive termination or expiration of this Agreement for any reason.

 

15.17.     Counterparts.      This Agreement is executed in two (2) counterparts, each of which shall be an original and all of which shall constitute together the same document.

 

SIGNATURE PAGE TO FOLLOW

 

IN WITNESS WHEREOF, the Parties have executed this Agreement in two originals by their duly authorized officers as of the date and year first above written.

 

	
Signed by: acting   by its duly authorized signatories in the presence of:
    	
ZEALAND   PHARMA A/S
    
	
 
    	
By:
    	
/s/ Mogens Vang   Rasmussen
    	
 
    
	
 
    	
 
    	
Authorised Signatory
    
	
Signature:
    	
/s/ Christina Guldberg
    	
 
    	
 
    
	
 
    	
 
    	
Witness
    	
 
    	
Name:
    	
Mogens Vang Rasmussen
    
	
 
    	
 
    	
 
    	
Chief Operating   Officer &
    
	
Name:
    	
Christina Guldberg
    	
 
    	
Chief Financial Officer
    
	
 
    	
 
    
	
Occupation:Project   Manager
    	
By:
    	
/s/ David H.   Solomon
    	
 
    
	
 
    	
 
    	
Authorised Signatory
    
	
Address:
    	
Smedland 36
    	
 
    
	
 
    	
2600
    	
Name:
    	
David H. Solomon
    
	
 
    	
Glostrup Denmark
    	
 
    	
Chief Executive Officer
    
	
 
    	
 
    
	
Signed by:
    	
HELSINN   HEALTHCARE SA
    
	
acting by its duly   authorized signatories in the presence of:
    	
 
    
	
 
    	
By:
    	
/s/ Giorgio Calderari
    	
 
    
	
 
    	
 
    	
Authorised Signatory
    
	
 Signature:
    	
/s/ Roberto De Ponti
    	
 
    	
 
    	
 
    
	
 
    	
Witness
    	
Name:
    	
Giorgio Calderari
    
	
 
    	
 
    	
 
    	
Chief Operating Officer
    
	
Name:
    	
Roberto De Ponti
    	
 
    	
 
    
	
 
    	
 
    	
By:
    	
/s/ Riccardo Braglia
    	
 
    
	
Occupation:
    	
Senior Director,
    	
 
    	
Authorised Signatory
    
	
 
    	
Business Development
    	
 
    	
 
    
	
 
    	
Name:
    	
Riccardo Braglia
    
									

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

39

 

	
Address:
    	
Via Pian Scairolo 9
    	
Chief Executive Officer   
    
	
 
    	
6912 Pazzallo Lugano 
    	
Managing Director
    
	
 
    	
Switzerland
    	
 
    

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

40

 

EXHIBIT 1

 

BACK-UP COMPOUNDS

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

41

 

Back-up Compounds ([***])

 

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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

44

 

	
 
    	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

45

 

	
 
    	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

46

 

	
 
    	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

47

 

	
 
    	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

48

 

 

	
 
    	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

49

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

50

 

EXHIBIT 2

 

EXISTING AGREEMENTS

 

A: Completed Studies/activities

 

	
CRO
    	
 
    	
Report Title
    	
 
    	
ZP study
   number
    
	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

51

 

	
CRO
    	
 
    	
Report Title
    	
 
    	
ZP study
   number
    
	
[***]
    	
 
    	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

52

 

	
CRO
    	
 
    	
Report Title
    	
 
    	
ZP study
   number
    
	
[***]
    	
 
    	
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B: Ongoing studies/activities

 

[***]

 

[***]:

 

·                                          [***]

 

·                                         [***]

 

·                                         [***]

 

·                                          [***]

 

[***]:

 

·                                          [***]

 

·                                          [***]

 

[***]*:

 

·                                          [***]

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

53

 

B2: Ongoing studies/activities

 

	
Contract Title
    	
 
    	
Date
    	
 
    	
CMO/CRO
    	
 
    	
Report Title: ongoing activity
    	
 
    	
Study No.
    
	
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[***]
    	
 
    	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

54

 

EXHIBIT 3

 

TENTATIVE DEVELOPMENT PLAN

 

	
ACTIVITY
    	
 
    	
COMPLETION
   DATE
   (no later than)
    
	
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[***]
    	
 
    	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

55

 

EXHIBIT 4

 

ZEALAND KNOW-HOW

 

Study Reports [***]

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

56

 

	
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57

 

	
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58

 

	
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59

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

60

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

61

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

62

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

63

 

	
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Outstanding Reports [***]

 

	
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Regulatory Agency Documentation:

 

	
IND Serials
    
	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

64

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

65

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

66

 

	
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Non-held Pre-IND Briefing meeting
    
	
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Orphan drug designation
    
	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

67

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

68

 

Publications:

 

	
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Publications:

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

69

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

70

 

Standard Operating Procedures

 

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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

71

 

Intellectual Property

 

[***]

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

72

 

EXHIBIT 5

 

ZEALAND PATENTS

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

73

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

74

 

EXHIBIT 6

 

INVENTORY OF MATERIALS TO BE TRANSFERRED TO HELSINN

 

[***]

 

1.  [***]

 

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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

75

 

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4. [***]

 

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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

76

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

77

 

EXHIBIT 7

 

1. Compound

 

	
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2. Product

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

78

 

 

EXHIBIT 8

 

EXPERT PROCEDURE

 

1.             In the event of any dispute which is to be submitted for consideration by an expert pursuant to Article 7.4.3, Article 7.5.3 or Article 12.2.1(i), the following procedure shall be adopted. Such dispute shall be referred to an independent person (the “Expert”) who shall act as an expert and not as an arbitrator and whose opinion in relation to the matter in dispute shall be binding upon the Parties.

 

2.             Such dispute shall be treated as confidential by the Parties, the Expert and the Parties’ legal representatives. Unless required by Law, no disclosures shall be made to any Third Party of the existence of the dispute or any information, materials or documents (or part thereof) provided by or to the Expert (whether orally or in writing) or of the Expert’s opinion (or part thereof).

 

3.             The procedure for the appointment of the Expert in accordance with this Exhibit shall be as follows:

 

3.1.         The Party wishing the appointment to be made shall give notice to that effect to the other Party and with such notice shall give details of the matters in dispute which it wishes to refer to an Expert.

 

3.2.         If within 14 days from the service of the notice by the Party wishing to refer a matter to an Expert the Parties have failed to agree upon the identity of the person to be appointed as the Expert then that Party may apply to the Association of the British Pharmaceutical Industry (the “Appointing Authority”) to appoint a person to act as an Expert to determine the matters in dispute requesting that the appointment be made within seven (7) days of receipt of the request by the Appointing Authority.

 

3.3.         The person identified to act as an Expert shall confirm within 7 days whether or not he is willing and able to accept the appointment and whether he is prepared to agree to accept the confidentiality requirements set out at paragraph 2 above.

 

3.4.         In the event that the Expert so appointed does not confirm his availability to act and accept the confidentiality requirements within 7 days then either Party may request the Appointing Authority to suggest an alternative appointment until a person so identified confirms he is willing to accept the appointment and to accept the confidentiality requirements.

 

3.5.         No person shall be appointed to act as an Expert under this agreement unless he is qualified by education, experience and training to offer an expert, binding opinion on the matter in dispute.

 

3.6.         Any person appointed to act as an Expert pursuant to this agreement shall at the time of confirming that he is willing and able to accept such appointment disclose to both parties any contact or relationship with either Party and otherwise disclose to the Parties any duty or

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

79

 

interest which does or may create a conflict or otherwise impinge upon the matters in dispute upon which lie is to be appointed to offer a binding opinion. If any such disclosure is made, either Party may object to the appointment within 7 days in which case the procedure for appointing the Expert referred to in paragraphs 3.2 to 3.5 above shall be repeated. For the avoidance of doubt, no person shall be appointed an Expert under this agreement who at the time of appointment is a director, office holder, or employee of or directly or indirectly retained as a consultant or in any other professional capacity by either Party or its Affiliates.

 

3.7.         Upon the person appointed as Expert confirming his willingness and ability to accept the appointment and upon neither Party having raising any objection to the appointment in the light of any disclosure made by the Expert in accordance with paragraph 3.6 above, the Parties shall jointly send a letter to the Expert containing the terms of his appointment including, inter alia, the following:

 

(a)           that the Expert shall not later than 7 days after the confirmation of his appointment:

 

(i)            request from the Parties all written submissions upon which they intend to rely (the “Request”), to be delivered to the Expert within 14 days of the date of the Request; and

 

(ii)           call the Parties to attend a meeting to be held on a mutually convenient date which will last no longer than one day; and which will take place within 30 days of the date of the Request;

 

(b)           that the Expert shall issue his binding opinion as soon as reasonably practicable after such meeting. In any event, the Expert shall endeavour to issue his binding opinion within 7 days of such meeting;

 

(c)           that the Expert shall give full written reasons for his determination.

 

4.             For the avoidance of doubt, any person appointed to offer a binding opinion in accordance with this clause shall act as an Expert and not as an arbitrator and the provisions of the Arbitration Act 1996 (as amended from time to time) and the law relating to arbitrations shall not apply to such Expert or his binding opinion or the procedure by which he reaches his binding opinion.

 

5.             In respect of a dispute referred to an Expert pursuant to Article 7.4.3 or pursuant to Article 12.2.1(i), each Party shall bear their own costs in connection with the reference of a dispute to an Expert and the costs of the Expert will be paid jointly by the Parties. The Expert shall be entitled, at the procedure meeting referred to in paragraph 3.7(a) above, to require the Parties to provide a deposit in respect of his costs of the reference.

 

6.             In respect of a dispute referred to an Expert pursuant to Article 7.5.3, the Party found in error shall bear the reasonable costs of both Parties in connection with the reference of a dispute to an Expert and shall also bear the costs of the Expert. The Expert shall be entitled, at the procedure meeting referred to in paragraph 3.7(a) above, to require the Parties to provide a deposit

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

80

 

in respect of his costs of the reference (with such amount paid by the Party not found to be in error to be reimbursed by the Party found to be in error).

 

7.             The opinion of the Expert shall be binding upon the Parties.

 

8.             Save for submissions made orally to the Expert at a meeting at which the parties are present, any other communication between a Party and the Expert shall be made in writing and a copy thereof shall be provided simultaneously to the other Party. For the avoidance of doubt, no meeting between the Expert and a Party shall take place unless both parties have had notice of such meeting and have been offered a reasonably opportunity to attend such meeting.

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

81

 

Addendum

 

to the

 

License Agreement, Effective Date November 26, 2008
  (Hereafter referred to as the “License Agreement”)

 

between

 

Zealand Pharma A/S

 

and

 

Helsinn Healthcare SA

 

Made on July 1, 2010

 

Capitalized terms used and not otherwise defined herein shall have the meanings given to such terms in the License Agreement.

 

WHEREAS:

 

a)             According to Article 4.1 of the License Agreement ZEALAND has provided HELSINN with certain ZEALAND Know-How, existing at the Effective Date of the License Agreement, including [***] to be used for the analysis of [***] in clinical trials for the Products (“Former Methodology”);

 

b)             Due to the fact that the Former Methodology does not fit for the above purpose, ZEALAND has agreed to develop and provide to HELSINN a new analytical methodology, to be used by HELSINN for the same purpose.

 

NOW, THEREFORE, in consideration of the mutual promises, covenants and conditions hereinafter set forth, the Parties hereto mutually agree as follows.

 

*** Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

1

 

1.              ZEALAND undertakes to develop [***] methodology for the analysis of the Products [***] for the analysis of clinical trial samples (“New Methodology”) and to devote the required personnel time, attention and abilities as necessary for the performance of the activities hereunder.

 

2.              In order for ZEALAND to define method specifications, Helsinn shall promptly provide all relevant study information including [***] tested by HELSINN in the Phase lb clinical study currently ongoing.

 

3.              The New Methodology shall have [***] as described in Exhibit 2 attached hereto as an integral part of this addendum letter and shall be sufficient for the PK analysis in the Phase lb clinical study currently ongoing.

 

4.              The New Methodology shall fully comply with the applicable GLP analytical guidelines as described in paragraph 3 above and more extensively described in Exhibit 2 attached hereto.

 

5.              ZEALAND shall (i) develop the New Methodology under the direction of HELSINN, who shall be kept adequately informed by ZEALAND of the progress of the activities hereunder, (ii) exercise its best efforts to complete the New Methodology on behalf of HELSINN and assist HELSINN in the transfer and validation of the New Methodology to any of its nominees, as shall be indicated in due time by HELSINN in writing, as soon as possible and in any case within the timelines set forth in the Gantt Chart document attached hereto in Exhibit 1, as an integral part of this addendum letter and (iii) give its assistance and advice to HELSINN and/or HELSINN’s nominee for the purpose of the New Methodology validation.

 

6.              ZEALAND is not responsible for delays resulting from tasks performed by HELSINN and/or HELSINN’s nominee, including but not limited to the tasks described in Exhibit 1, which are not under ZEALAND exclusive control.

 

7.              In consideration of all the work to be carried out and all activities to be performed under this addendum letter, HELSINN shall pay to ZEALAND the overall amount of [***], plus VAT if applicable, in two installments as follows:

 

7.1                     [***] as upfront fee upon the last execution date of this addendum letter; and

 

7.2                     [***] upon successful completion of the New Methodology validation phase according to the specifications set forth in paragraph 3 above and in Exhibit 2 attached hereto.

 

Payments shall be made by HELSINN within 30 (thirty) days from the date of receipt of the relevant invoice to be issued by ZEALAND.

 

8.              In the event that the New Methodology should not meet the specifications described in paragraph 3 above and in Exhibit 2 hereto, and therefore HELSINN should not be able to use the New Methodology for the above purpose, then the milestone set forth in paragraph 7.2 above will only be due when ZEALAND (i) has undertaken a 2nd round of method

 

*** Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

2

 

development, free of charge, with the aim to provide HELSINN with an analytical method meeting the requirements outlined in paragraph 3 above and in Exhibit 2, and (ii) has successfully completed the validation of such further new analytical method according to the specifications described in paragraph 3 above and in Exhibit 2 hereto, at a third party designated by Helsinn.

 

9.              It is understood and agreed between the parties that the New Methodology, to be developed and validated hereunder, shall be delivered by ZEALAND to HELSINN, or its nominee as shall be indicated in due time by HELSINN in writing, accompanied by any and all appropriate supporting documents and data and shall remain HELSINN’s property. ZEALAND shall have the irrevocable right to use any Know-How arising from development of the New Methodology for internal research purposes.

 

IN WITNESS WHEREOF, the parties hereto have executed this addendum letter effective as of the date first written above in duplicate.

 

	
For and on behalf of

ZEALAND PHARMA A/S
    	
For and on behalf of

HELSINN HEALTHCARE SA
    
	
 
    	
 
    
	
By: 
    	
/s/ David H. Solomon
    	
By: 
    	
/s/ Giorgio Calderari
    
	
David H. Solomon
    	
Giorgio Calderari
    
	
President Chief   Executive Office
    	
Group General Manager
    
	
Date:
    	
Date:
    
				

 

*** Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

3

 

EXHIBIT 1

 

GANTT CHART

 

See enclosed document.

 

[***]

 

*** Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

4

 

EXHIBIT 2
 Specifications

 

	
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*** Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

5

 

AMENDMENT No. 1 TO THE LICENSE AGREEMENT

 

This Amendment No. 1 to the License Agreement (“Agreement”) between Zealand Pharma A/S, a corporation organized and existing under the law of Denmark and having its registered office at Smedeland 36, DK-2600 Glostrup, Denmark (“Zealand”) and Helsinn Healthcare SA, a corporation organized and existing under the laws of Switzerland and having its registered office at Via Pian Scairolo 9, 6912 Lugano, Switzerland (“Helsinn”), is effective as of 24th November, 2015.

 

WHEREAS, this Amendment No. 1 relates to the Agreement entered into between Zealand and Helsinn effective November 26th, 2008, together with its relevant addendum made on July 1st, 2010;

 

WHEREAS, Zealand and Helsinn wish to amend the Agreement to extend the Designation Period set forth in Article 2.5 until the end of November 2017;

 

WHEREAS, all capitalized terms used herein shall have the same meaning as set forth in the Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants and conditions hereinafter set forth, the Parties agree as follows:

 

1.                                      The Designation Period indicated at Article 2.5 of the Agreement (i.e. “[***]”) is hereby extended until [***].

 

As a consequence of the above, all references to the Designation Period contained in the Agreement are intended to be made to that new period expiring on [***].

 

2.                                      In addition Zealand and Helsinn agree that Zealand in the Designation Period shall prosecute and maintain ZEALAND Patents as outlined in Annex I attached hereto.

 

3.                                      Moreover, Zealand and Helsinn agree that Helsinn may maintain and prosecute ZEALAND Patents as outlined in Annex II attached hereto.

 

4.                                      Zealand and Helsinn agree that Zealand shall keep [***] in the Designation Period.

 

5.                                      Exhibit 5 of the Agreement is hereby entirely deleted and replaced by the new Exhibit 5 as outlined in Annexes I and II attached hereto.

 

6.                                      Except as specifically amended herein, the Agreement remains in full force and effect and is hereby ratified and confirmed by the Parties.

 

	
For and on behalf of,
    	
 
    	
For and on behalf of,
    
	
ZEALAND PHARMA A/S
    	
 
    	
HELSINN HEALTHCARE SA
    
	
 
    	
 
    	
 
    
	
/s/ Britt Meelby Jensen
    	
 
    	
/s/ Giorgio Calderari
    
	
Britt Meelby Jensen
    	
 
    	
Giorgio Calderari
    
	
CEO
    	
 
    	
Group General Manager
    

 

[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

1

 

ANNEX 1 — [***]

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

2

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

3

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

4

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

5

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

6

 

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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

7

 

	
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[***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission.  Confidential treatment has been requested separately with respect to the omitted portions.

 

8Exhibit 10.5

 

STRICTLY CONFIDENTIAL

 

	
CO-DEVELOPMENT AGREEMENT
    
	
 
    	
 
    
	
Between
    	
Zealand Pharma A/S
    
	
 
    	
Smedeland 36
    
	
 
    	
DK-2600 Glostrup
    
	
 
    	
Denmark
    
	
 
    	
 
    
	
and
    	
Beta Bionics
    
	
 
    	
Business Innovation Center,   Photonics Center
    
	
 
    	
8 Saint Mary’s Street,   Suite 936
    
	
 
    	
Boston, MA 02215-2421
    
	
 
    	
USA
    

 

 

TABLE OF CONTENTS

 

	
1
    	
AIM AND PURPOSES
    	
12
    
	
2
    	
NON-EXCLUSIVITY
    	
13
    
	
3
    	
GOVERNANCE
    	
13
    
	
4
    	
REGULATORY PROJECT   MANAGEMENT, INTERACTIONS, INSPECTIONS AND QUALITY ASSURANCE
    	
15
    
	
5
    	
COMMITMENTS AND   CONTRIBUTIONS
    	
19
    
	
6
    	
OWNERSHIP OF   PROPRIETARY IP AND CLINICAL DATA
    	
19
    
	
7
    	
LICENSE TO PROPRIETARY   IP FOR CO-DEVELOPMENT ACTIVITIES
    	
21
    
	
8
    	
ACCESS TO CLINICAL DATA
    	
21
    
	
9
    	
CONFIDENTIALITY
    	
22
    
	
10
    	
PUBLICATION
    	
25
    
	
11
    	
FORCE MAJEURE
    	
25
    
	
12
    	
REPRESENTATIONS AND   WARRANTIES
    	
26
    
	
13
    	
LIABILITY
    	
26
    
	
14
    	
INDEMNIFICATION
    	
26
    
	
15
    	
TERM AND TERMINATION
    	
28
    
	
16
    	
COMMUNICATION
    	
30
    
	
17
    	
GOVERNING LAW
    	
30
    
	
18
    	
NOTICES
    	
31
    
	
19
    	
MISCELLANEOUS
    	
31
    

 

2

 

	
EXHIBIT INDEX
    
	
 
    
	
Exhibit no. 1:
    

 

3

 

INDEX OF DEFINED TERMS

 

	
Affiliate
    	
 
    	
means, with respect to a specified Person, a Person   that directly, or indirectly through one or more intermediaries, Controls, is   Controlled by or is under common Control with, the specified Person.
    
	
 
    	
 
    	
 
    
	
Agreement
    	
 
    	
means this agreement with the Exhibit.
    
	
 
    	
 
    	
 
    
	
Applicable Law
    	
 
    	
means any and all applicable laws, statutes,   regulations, directives and other legally binding requirements of any   national, sub-national or supra-national governmental authority, including   any judicial or administrative interpretation of the foregoing and any   applicable rules, government regulatory requirements, mandatory or generally   applied industry standards such as codes of conduct and current guidelines,   all as amended from time to time.
    
	
 
    	
 
    	
 
    
	
Clinical Data
    	
 
    	
Any and all data, records, analyses, results,   information and the like obtained or developed in the performance of the   Co-development Activities and reasonably required for submissions made for   the approval or maintenance of regulatory approvals for
    

 

4

 

	
 
    	
 
    	
medical devices, pharmaceutical products or   combinations thereof.
    
	
 
    	
 
    	
 
    
	
Co-development Activity or Co-Development Activities
    	
 
    	
is defined in Clause 1.1.
    
	
 
    	
 
    	
 
    
	
Confidential Information
    	
 
    	
has the meaning given to it in Clause 9.1.
    
	
 
    	
 
    	
 
    
	
Control
    	
 
    	
when used with respect to a Person, means   (a) the possession of the power to vote on 50 (fifty)% or more of the securities   or other equity interest of a Person having ordinary voting power, or   (b) the possession of the power to direct or cause the direction of the   management and policies of a Person, by contract or otherwise; and
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
when used with respect to Intellectual Property   Rights, the right (by ownership, under a license or otherwise) to grant a   license or sublicense with respect to such Intellectual Property Rights   without breaching an obligation to a Third Party or incurring additional   costs that are not de minimis.
    
	
 
    	
 
    	
 
    
	
CRO
    	
 
    	
means a Contract Research Organisation providing   research services in connection with a clinical trial to or on behalf of   Sponsor.
    
	
 
    	
 
    	
 
    
	
Direct Competitor
    	
 
    	
means (i) in relation to Zealand a Person which   is or intends to be involved in activities concerning
    

 

5

 

	
 
    	
 
    	
development or commercialisation of glucagon and/or   glucagon analogues for diabetes, and (ii) in relation to BB a Person   which is or intends to be involved in activities concerning development of a   dual hormone artificial pancreas device for diabetes.
    
	
 
    	
 
    	
 
    
	
Disclosing Party
    	
 
    	
means the Party disclosing Confidential Information   under this Agreement.
    
	
 
    	
 
    	
 
    
	
Effective Date
    	
 
    	
means 1st January 2017.
    
	
 
    	
 
    	
 
    
	
EMA
    	
 
    	
means the European Medicines Agency or any successor   thereto having the administrative authority to regulate the marketing of   pharmaceutical products and medical devices in the European Union (as   applicable).
    
	
 
    	
 
    	
 
    
	
Exhibit
    	
 
    	
means the exhibit referred to in this Agreement.
    
	
 
    	
 
    	
 
    
	
FDA
    	
 
    	
means the United States of America Food and Drug   Administration, or any successor thereto having the administrative authority   to regulate the marketing of pharmaceutical products and medical devices in   the United States of America.
    
	
 
    	
 
    	
 
    
	
iLet
    	
 
    	
means iLet, iLet Infusion Sets and fillable insulin   cartridge.
    

 

6

 

	
iLet/ZP4207 Trials
    	
 
    	
means pre-clinical and clinical trials of ZP4207   administered with an iLet, including trials with a placebo or active   comparator and with other interventions (such as insulin), with Zealand as   Sponsor and BB as supplier of iLets.
    
	
 
    	
 
    	
 
    
	
Intellectual Property Rights
    	
 
    	
means all intellectual property rights of any kind   (whether or not they can be subject to registration and whether or not they   are registered or are subject to an application for registration), including,   but not limited to, rights to inventions, improvements thereto, discoveries,   Patent Rights, trademarks, logos, rights in designs, trade or business names,   domain names, copyrighted works (including software), and databases, as well   as rights in Know-how, and all other rights or forms of protection of a   similar nature.
    
	
 
    	
 
    	
 
    
	
ISO Standard
    	
 
    	
means the standards promulgated by the International   Organization for Standization.
    
	
 
    	
 
    	
 
    
	
Institution
    	
 
    	
means an institution at or by which a clinical trial   is conducted.
    
	
 
    	
 
    	
 
    
	
JDC
    	
 
    	
has the meaning given to it in Clause 3.1.
    

 

7

 

	
Know-how
    	
 
    	
means any and all proprietary or confidential   know-how, data or other information, including without limitation, Clinical   Data, knowledge, experience, inventions, improvements, processes, technical   information, technology, ideas, instructions, or any materials, reagents or   other substance.
    
	
 
    	
 
    	
 
    
	
Patent Rights
    	
 
    	
means any and all (i) patents, (ii) patent   applications (if not pending for more than seven (7) years after initial   application), and (iii) all other rights or forms of protection of a   similar nature.
    
	
 
    	
 
    	
 
    
	
Person
    	
 
    	
means any individual, company, partnership or other   entity of any kind.
    
	
 
    	
 
    	
 
    
	
Proprietary IP
    	
 
    	
Intellectual Property Rights which are owned or   Controlled by a Party or the Party’s Affiliates as of the Effective Date of   the Co-development Agreement, or become owned or Controlled by said Party or   the Party’s Affiliates during the term of the Co-development Agreement
    
	
 
    	
 
    	
 
    
	
Purposes
    	
 
    	
has the meaning given to it in Clause 1.2.
    
	
 
    	
 
    	
 
    
	
Receiving Party
    	
 
    	
means the Party receiving Confidential information   under this Agreement.
    

 

8

 

	
R&D Plan
    	
 
    	
has the meaning given to it in Clause 3.1.5.
    
	
 
    	
 
    	
 
    
	
Regulatory Information
    	
 
    	
has the meaning given to it in Clause 4.13.
    
	
 
    	
 
    	
 
    
	
Representative
    	
 
    	
means any employee, consultant, agent or other   Person acting on behalf of a Party.
    
	
 
    	
 
    	
 
    
	
Sponsor
    	
 
    	
means a Person considered a sponsor of a clinical   trial under Applicable Law.
    
	
 
    	
 
    	
 
    
	
Supply Agreement
    	
 
    	
has the meaning given to it in Clause 4.4.
    
	
 
    	
 
    	
 
    
	
Term
    	
 
    	
means the period from the Effective Date until this   Agreement has effectively expired or been terminated.
    
	
 
    	
 
    	
 
    
	
Third Party
    	
 
    	
means any Person other than Zealand and BB or any of   their respective Affiliates.
    
	
 
    	
 
    	
 
    
	
Third Party Rights
    	
 
    	
means any Intellectual Property Rights or other   rights of a Third Party.
    
	
 
    	
 
    	
 
    
	
ZP4207
    	
 
    	
means the soluble and stable glucagon analogue for   administration in a liquid formulation and packaged in a primary container   system,
    

 

9

 

	
 
    	
 
    	
referred to by Zealand as ZP4207.
    

 

In this Agreement, unless the context otherwise requires, words denoting the singular number include the plural and vice versa.

 

10

 

This Co-development Agreement (the “Agreement”) is entered into on February 10, 2017 by and between:

 

(1)                                                   Zealand Pharma A/S, a privately held limited company (Aktieselskab) incorporated under the laws of the Kingdom of Denmark, whose registered office is Smedeland 36, 2600 Glostrup, Denmark, registered with the Danish Business Authority under CVR no. 20045078 (“Zealand”), and

 

(2)                                                   Beta Bionics, Inc., a Massachusetts public benefit corporation, whose registered office is: Business Innovation Center, Photonics Center, 8 Saint Mary’s Street, Suite 936, Boston, MA 02215-2421, USA - Zealand and BB hereinafter collectively referred to as the “Parties” and separately as a “Party”.

 

WHEREAS

 

(A)           Zealand is advancing a pipeline of investigational pharmaceutical products alongside partnered products and has a mission to discover and develop proprietary peptide pharmaceutical products and accompanying solutions that improve people’s lives, including a physically and chemically stable and soluble glucagon analogue, ZP4207, for the treatment of hypoglycaemia in diabetes patients.

 

(B)           BB has a mission to bring a dual-hormone bionic pancreas device system to the home of patients living with insulin-dependent diabetes. The goal of the bionic pancreas is to relieve persons with insulin-dependent diabetes of the burden of managing the disease and by automating the dosing of insulin and glucagon to manage blood sugar levels in people with insulin-dependent diabetes. This will improve diabetes treatment and quality of life while resulting in diminished societal costs.

 

(C)           The Parties have entered into a mutual non-disclosure and confidentiality agreement of 30 November 2015 (the “Confidentiality Agreement”), to explore a possible business and/or scientific relationship, and a term sheet of 14th December 2016 (the “Term Sheet”) to agree on the overall principles and terms of the Parties’ future Co-development Activities and regulatory interactions. The Parties now wish to enter into an agreement specifying the overall framework of the relationship.

 

NOW IT IS HEREBY AGREED AS FOLLOWS:

 

11

 

1                                                           Aim and Purposes

 

1.1                                                 The overall aim of this Agreement is to define the general principles, roles, responsibilities and commitments of the Parties with respect to iLet/ZP4207 Trials, related data sharing, the supply of and access to iLets for the iLet/ZP4207 Trials and related interactions with regulatory authorities (the “Co-development Activities”), all in order to facilitate the achievement of the Purposes. Specific Co-development Activities shall be approved by the joint development committee provided for herein. It is the intent of the Parties to define the principles and commitments for potential commercial supply agreements for iLets at a later point during the collaboration.

 

1.2                                                 The purposes of the collaboration under this Agreement are (i) the development by Zealand of ZP4207 with the goal of obtaining regulatory approval for ZP4207 for use inter alia in a dual-hormone artificial pancreas device, and (ii) the development by BB of the iLet as a dual-hormone artificial pancreas device with the goal of obtaining regulatory approval for the iLet (the “Purposes”).

 

12

 

2                                                           Non-exclusivity

 

2.1                                                 The Parties’ collaboration under this Agreement is not exclusive which means among other things and without limitation that:

 

(i) the Agreement shall not prevent Zealand from engaging in development and commercialisation activities itself or with Third Parties concerning the development and commercialisation of ZP4207;

 

(ii) the Agreement shall not prevent BB from engaging in development and commercialisation activities itself or with Third Parties concerning the development and commercialisation of the iLet.

 

3                                                           Governance

 

3.1                                                 Joint Development Committee

 

3.1.1                                       The Parties shall establish a joint development committee (the “JDC”), which shall have the authority to make decisions within the following areas of responsibilities:

 

(i)                                                       Approve Co-development Activities;

 

(ii)                                                    Develop and maintain an R&D Plan for the Co-development Activities;

 

(iii)                                                 Allocate development activities, responsibilities and tasks between the Parties as related to each specific Co-development Activity in order to achieve the Purposes;

 

(iv)                                                Prepare agreements/work orders for signature by the Parties on each specific Co-development Activity in relation to the specific project plans (such as a Supply Agreement described in Clause 4.4 - 4.7, specifying inter alia timelines and quantities for iLets to be provided by BB to Zealand);

 

(v)                                                   Prepare a quality agreement for signature of the parties as described in Clause 4.3;

 

(vi)                                                Monitor compliance with regulatory requirements relating to the Co-development Activities;

 

(vii)                                             Oversee the overall collaboration and reviewing progress and results of the Co-development Activities;

 

13

 

(viii)                                          Discuss and agree on how to initiate, align, manage, use, act upon and share communications with the FDA, EMA and other relevant authorities or ethical committees as related to each specific Co-development Activity and/or in order to achieve the Purposes;

 

(ix)                                                Develop a plan for the publication of the Clinical Data in accordance with Clause 10.

 

3.1.2                                       Each Party shall appoint two (2) members to participate in the JDC, which shall have at least two (2) meetings each year either by telephone conference or in a face-to-face meeting, unless otherwise agreed between the Parties. The JDC shall form a quorum when all four (4) members are present or represented by another member by proxy.

 

3.1.3                                       The JDC shall be co-chaired by a representative of each Party. A secretary of the JDC will be appointed on an annual, calendar year, rotating basis by either Zealand or BB, with Zealand naming the first secretary. The decisions covered by the decision-making authority of the JDC shall be made by consensus of the representatives of the Parties. In the event that no consensus can be reached, the subject matter shall be escalated by notice from either Party to the [         ] of Zealand and the [           ] of BB for resolution, such senior executives to seek to achieve consensus within fifteen (15) days of such escalation. Should no such consensus be achieved, (1) Zealand shall have final decision-making authority with respect to all matters relating primarily to the development of ZP4207 or obtaining regulatory approval for ZP4207 for use inter alia in a dual-hormone artificial pancreas device, and (2) BB shall have final decision making authority with respect to all matters relating primarily to development of the iLet as a dual-hormone artificial pancreas device or obtaining regulatory approval for the iLet.

 

3.1.4                                       If the performance of a Co-development Activity faces obstacles, e.g. the existence of Third Party Rights, the JDC is to be informed immediately. Each Party shall be responsible for the enforcement of its Proprietary IP and the defense of any infringement claims arising from the Co-development Activities it performs, provided that, should a Party reasonably request that the other Party take any action to enforce or defend Intellectual Property Rights, the other Party shall do so, at the expense of the requesting Party.

 

14

 

3.1.5                                       The JDC shall on an on-going basis discuss and agree on an overall research and development plan (the “R&D Plan”) for pending and planned Co-development Activities. The R&D Plan shall be a non-binding guidance document, unless agreed otherwise in writing in relation to specific Co-development Activities.

 

3.1.6                                       The Parties shall initiate the development of the R&D Plan promptly after the Effective Date with the aim to finalise it as soon as possible.

 

3.2                                                 Contact Persons

 

3.2.1                                       Simultaneously with the signing of this Agreement, each Party will appoint one or two contact persons (“Contact Persons”). The Contact Persons shall support the collaboration and facilitate dialogue between the Parties. The Parties can at any time replace a Contact Person appointed by the Party.

 

3.2.2                                       The Parties have appointed the following Contact Persons:

 Zealand Pharma:

Adam Steensberg, CMO

 

BB:

 

[insert name and position] (will provide at signing)

 

4                                                           Regulatory project management, interactions, inspections and quality assurance

 

4.1                                                 By entering into this Agreement, the Parties agree to:

 

(i)                                                       in the performance of the Co-development Activities, comply with all Applicable Laws, including regulatory guidance and guidelines;

 

(ii)                                                    ensure timely and effective progress of the Co-development Activities;

 

(iii)                                                 agree on the commitments and contributions of the Parties, which shall be further specified in the R&D Plan and upon approval of Co-development Activities;

 

(iv)                                                ensure, document and maintain on a current basis reasonable detailed records of Clinical Data and Regulatory Information in respect of its performance of the Co-development Activities in and in connection with

 

15

 

iLet/ZP4207 Trials, in accordance with the Parties’ normal procedures, which shall comply with internationally recognized standards;

 

(v)                                                   keep and establish formal, retrievable and auditable records of contact with regulatory authorities relating to iLet/ZP4207 Trials, which shall be written up, archived systematically and shared between the Parties in a timely manner.

 

(vi)                                                collaborate and communicate timely and regularly to ensure the fastest and best possible approval from/clearance by the FDA, EMA and/or any relevant authority of proposed changes to iLet/ZP4207 Trial protocols, potential delays, quality issues and regulatory feedback that can impact agreed development timelines etc. and to discuss any interaction with the FDA, EMA and/or any national EU authorities prior to the contact with said authority; and

 

(vii)                                             issue all declarations, filings and documents relevant for the interactions with the FDA, EMA and/or any national EU authorities in connection with iLet/ZP4207 Trials, free of charge.

 

4.2                                                 Each Party shall have the right, at its own expense, to subcontract specific activities within the Co-development Activities to outside contractors, provided that (i) each Party shall be responsible for such subcontractors’ performance in accordance with the R&D Plan, and (ii) any such subcontractor will have entered into a written agreement with such Party that includes terms and conditions protecting and limiting the use of Confidential Information, Proprietary IP, Regulatory Information and Clinical Data of the other Party, at least to the same extent as provided herein, and requires such subcontractor and its personnel to assign to such Party all rights, title and interest in and to any Regulatory Information, Clinical Data and Intellectual Property Rights created, conceived or developed in connection with the performance of subcontracted activities. The representatives of each Party shall inform the representatives of the other Party on the JDC of a proposed subcontract. In the event Zealand or BB finds a particular subcontractor unacceptable, the responsible Party will use commercially reasonable efforts to identify an acceptable alternative subcontractor.

 

4.3                                                 The JDC shall prepare, for signature by the Parties, quality agreements covering the supply of iLets, other clinical trial materials and other goods or services for which quality agreements are customary or necessary for compliance with regulatory

 

16

 

obligations. Such quality agreements shall be completed before any related activities are conducted.

 

4.4                                                 The JDC shall further prepare for signature by the Parties supply agreements covering the terms, conditions and requirements of the supply of goods or services provided in connection with the iLet/ZP4207 Trials or Co-development Activities (each, a “Supply Agreement”). In particular, a Supply Agreement shall be prepared with respect to the supply of iLets for iLet/ZP4207 Trials.

 

4.5                                                 BB agrees that Zealand shall be a preferred partner of BB, and that BB, if capable of doing so, shall have an obligation to supply iLets to Zealand that meet applicable quality and GxP requirements for use in the Co-development Activities, provided however, that BB shall have no obligation to modify iLets or bear any costs or expenses of any kind that are solely attributable to regulatory approval of ZP4207, including but not limited to any and all clinical trial costs that are associated with portions of a given clinical study that are deemed necessary by regulatory agencies (for example, but not limited to, CDER at the US FDA) in order to satisfy drug exposure requirements for their glucagon analogs in the iLet. These additional requirements may include, for example (1) an increase in the size of the minimum required study cohort to test their new molecular entity relative to the size of the cohort required to test a reformulation of human biosynthetic glucagon, and/or in terms of (2) adding a continued access study to the end of the randomized control trial portion of a given study for the purposes of obtaining chronic exposure of a new molecular entity in the iLet in a subset of the cohort that participated in the randomized control trial portion that study.

 

4.6                                                 Except as may otherwise be agreed, BB is obligated to provide iLets for iLet/ZP4207 Trials at a price equal to manufacturing cost plus ten percent (10%). The quantities and other specific terms for the supply or delivery of iLet shall be agreed upon on a case-by-case basis in a Supply Agreement, provided that Zealand as a preferred partner shall be entitled to receive supply or delivery of the quantities requested if (i) such request is provided to BB in reasonable time, and (ii) BB is capable of offering the same quantities to a Third Party.

 

4.7                                                 The Supply Agreement shall include an obligation for BB to comply with Applicable Laws.

 

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4.8                                                 In case BB does not supply any iLets or bear any costs or expenses in a clinical study, such clinical study shall not be considered a Co-development Activity.

 

4.9                                                 Each Party shall ensure that Government or regulatory authorities are entitled in the exercise of their functions, during and after the Term, to inspect its and its Affiliates’ and subcontractors’ facilities, equipment, locations, documents, records, procedures, Representatives and information, in each case if and as related to the Co-development Activities.

 

4.10                                          Each Party shall notify the other, through its representatives on the JDC and without undue delay, by telephone and fax or email, if any government or regulatory authority begins to conduct, or gives notice of its intent to conduct, an inspection relating to the Co-development Activities. The notifying Party will provide the other’s JDC representatives with copies of all pertinent written and electronic documents issued by the government or regulatory authority and any proposed response, and the notifying party will incorporate all reasonable requests by the other Party for modifications to the proposed responses that pertain to the Co-development Activities. The Parties will also provide the JDC with a copy of all written and electronic documents, including the final responses, that pertain to the Co-development Activities provided to the government or regulatory authority, subject to confidentiality and privacy restrictions.

 

4.11                                          The Parties shall update each other on a regular basis, through the JDC, about the progress of the Co-development Activities and any interim results achieved and shall store all data, protocols, results and meeting minutes in a suitable data room as agreed by the JDC. The Parties shall inform each other, through the JDC, promptly, and no later than within three (3) business days, of any major, critical and/or significant findings/observation from the Co-development Activities. Each Party shall submit a written status report on its Co-development Activities to the JDC, at least five (5) business days prior to each JDC meeting.

 

4.12                                          The Parties shall update the Contact Persons without undue delay and the JDC on a regular basis about said Party’s correspondence etc. with the FDA, EMA and/or any national EU authorities and any progress, results etc. in this regard.

 

4.13                                          The Parties agree that all information, documents, analysis, reports and other correspondence between the Parties/a Party and the FDA, EMA and/or any relevant

 

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authority or ethical committee, submitted hereto or otherwise relating thereto, excluding Clinical Data (“Regulatory Information”) are confidential by nature and that such Regulatory Information may not be shared with Third Parties, unless authorized under Clause  9.

 

5                                                           Commitments and contributions

 

5.1                                                 BB’s commitments and contributions

 

(i)                                                       BB shall be responsible for ensuring that the iLet meets applicable ISO standards;

 

(ii)                                                    BB shall be responsible for and in charge of the regulatory approval of the iLet;

 

(iii)                                                 BB shall supply or deliver iLets to Zealand in accordance with Clause 4.4 - 4.7 and the Supply Agreement(s) entered into as provided in Clause 4.4.

 

(iv)                                                BB may on a case-by-case basis, in its discretion, provide funding for Co-development Activities for which Zealand is responsible.

 

5.2                                                 Zealand’s commitments and contributions

 

(i)                                                       Zealand shall be responsible for and in charge of the regulatory approval of ZP4207 for use as the glucagon component in an artificial pancreas system.

 

(ii)                                                    Zealand shall supply or deliver samples of ZP4207 to BB as may be provided in the Supply Agreement(s) entered into as provided in Clause 4.4.

 

(iii)                                                 Zealand may on a case-by-case basis, in its discretion, provide funding for Co-development Activities for which BB is responsible.

 

6                                                           Ownership of Proprietary IP and Clinical Data

 

6.1                                                 Ownership of Proprietary IP

 

6.1.1                                       All rights, title and interest in and to any and all Zealand Proprietary IP will remain vested in Zealand, and all rights, title and interest in and to any and all BB Proprietary IP will remain vested in BB.

 

6.2                                                 Ownership of Clinical Data

 

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6.2.1                                       For clinical trials where Zealand is the sole Sponsor, all rights, title and interest in and to any and all Clinical Data shall belong to Zealand.

 

6.2.2                                       For clinical trials where both Zealand and BB are Sponsors, all rights, title and interest in and to any and all Clinical Data shall belong to Zealand and BB jointly. Except with respect to an assignment, license or other transfer to a Direct Competitor of the other Party, each of Zealand and BB may use and may assign, license or otherwise transfer (through multiple tiers) such jointly-owned Clinical Data without the approval of the other Party and without an accounting, provided that at least seven (7) days prior notice shall be given for any assignment, license or other transfer of such jointly-owned Clinical Data, other than to a subcontractor as provided herein.

 

6.2.3                                       BB agrees that the Clinical Data discovered, developed, conceived or reduced to practice under or in connection with Co-development Activities where Zealand is the sole Sponsor is confidential by nature and may not be shared with Third Parties, unless authorized under the terms of the regulation of Confidential Information set out in Clause 9.

 

6.3                                                 Ownership of Intellectual Property Rights

 

6.3.1                                       All rights, title and interest in and to any and all Intellectual Property Rights created, developed, discovered, invented or reduced to practice as part of the performance of the Co-development Activities shall belong to Zealand if they are necessary or useful for research or development of ZP4207 or its manufacture, use or sale, including (for the avoidance of doubt) non-obvious improvements to standard cartridges available therefor. All other Intellectual Property Rights created, developed, discovered or reduced to practice as part of the performance of the Co-development Activities (1) shall belong to Beta Bionics if they directly and solely relate to the iLet or its manufacture and use, including all improvements and modifications to the iLet and consumables related thereto other than (for the avoidance of doubt) Zealand ́s ZP4207 and ZP 4207 cartridges, shall (2) if jointly created, developed, discovered, invented or reduced to practice by Representatives of Zealand and Beta Bionics, shall be owned jointly, and (3) if created, developed, discovered, invented or reduced to practice solely by Representatives of one of the Parties, shall belong solely to such Party. Except with respect to an assignment, license 

 

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or other transfer to a Direct Competitor of the other Party, each of Zealand and BB may use and may assign, license or otherwise transfer (through multiple tiers) such jointly-owned Intellectual Property Rights without the approval of the other Party and without an accounting, provided that at least seven (7) days prior notice shall be given for any assignment, license or other transfer of such jointly-owned Intellectual Property Rights, other than to a subcontractor as provided herein .

 

6.3.2                                       The Parties shall ensure that all rights, title and interest in and to any and all Intellectual Property Rights generated by its Representatives and subcontractors will be transferred and assigned to such Party in accordance with Applicable Law. Each Party shall bear the cost of any obligations towards such Party’s Representatives with respect to Intellectual Property created by such Representatives and owned by such Party hereunder; should ownership be joint, the cost of such obligations shall be borne equally by the Parties.

 

6.3.3                                       The Parties shall refrain from and ensure that their Representatives and subcontractors refrain, from any novelty destroying act and to duly cooperate and issue all relevant declarations and make all filings free of charge to enable the issuance, registration, transfer, prosecution and maintenance of Intellectual Property Rights.

 

7                                                           License to Proprietary IP for Co-development Activities

 

7.1                                                 In respect of and only for the purpose of carrying out each individual Co-development Activity, each Party hereby grants the other a world-wide, perpetual, royalty-free, sub licensable (through multiple tiers), non-exclusive right and license to exploit each other’s Proprietary IP. For the avoidance of doubt, the license to Proprietary IP as per this Clause 7.1 shall not include, neither wholly, partially, directly or indirectly, a right to commercially or otherwise the other Party’s Proprietary IP, including, but not limited to, reverse engineer, reproduce or produce the other Party’s Proprietary IP; the iLet or ZP4207.

 

8                                                           Access to Clinical Data

 

8.1                                                 For Co-development Activities where Zealand is the sole Sponsor, BB shall have access to use the Clinical Data in relation to and only to the extent necessary for achieving the Purposes. However, Zealand accepts that BB may use the results of

 

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the specific Co Development Activities for further academic research purposes as required by the terms of BB’s license agreement with The Trustees of Boston University.

 

9                                                           Confidentiality

 

9.1                                                 For the purpose of this Agreement “Confidential Information” means, in relation to either Party, this Agreement and its terms and conditions and information which is disclosed to that Party by or in respect of the other Party under or in connection with this Agreement, in particular all commercial and operational information, Proprietary IP, Know-how, Clinical Data, Regulatory Information, inventions, formulae, plans, specifications, designs, software programs and samples, and any other information not generally known or reasonably ascertainable (whether orally or in writing or in any other medium, and whether or not the information is expressly stated to be confidential or proprietary or marked as such). Confidential Information does not include information which

 

(i)                                                       is in or comes into the public domain without breach of this Clause 9 by the Receiving Party;

 

(ii)                                                    was, as established by written evidence, in the possession of the Receiving Party prior to receipt from the Disclosing Party and was not acquired by the Receiving Party from the Disclosing Party under an obligation of confidentiality or non-use;

 

(iii)                                                 is acquired by the Receiving Party from a Third Party not under an obligation of confidentiality or non-use towards the Disclosing Party;

 

(iv)                                                the Disclosing Party in writing specifically informs the Receiving Party is not to be considered Confidential Information, or

 

(v)                                                   is, as established by written evidence, independently developed by the Receiving Party without use of any Confidential Information of the disclosing Party.

 

9.2                                                 The Parties agree that with respect to the Clinical Data and Intellectual Property Rights, (i) Zealand shall be deemed the Disclosing Party with respect to any Clinical 

 

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Data and Intellectual Property Rights solely owned by Zealand pursuant to this Agreement, and (ii) BB shall be deemed the Disclosing Party with respect to any Clinical Data and Intellectual Property Rights solely owned by BB pursuant to this Agreement. Jointly owned Intellectual Property Rights shall be deemed the Confidential information of both Parties.

 

9.3                                                 Without the prior written consent of the Disclosing Party, apart from what is required by Applicable Law or by any court or other authority of competent jurisdiction or the rules or regulations of any stock exchange, the Receiving Party shall keep confidential all Confidential Information and will not use Confidential Information of the Disclosing Party or disclose it to any Third Party, except to fulfil its obligations under this Agreement, and will not disclose the fact that the Disclosing Party has made its Confidential Information available to the Receiving Party.

 

9.4                                                 In the event that the Receiving Party becomes compelled (pursuant to any law, regulation, the requirement of a stock exchange or other regulatory organization), to disclose any part of the Confidential Information, it shall promptly (and, in any event where reasonably practical to do so, before complying with any such requirement) notify the Disclosing Party in writing of its intention to make such disclosure. In such event, Receiving Party will cooperate with Disclosing Party should Disclosing Party decide to seek a protective order or other reliable assurance that confidential treatment will be accorded to the Confidential Information. If such protective order or other remedy is not obtained, Receiving Party will furnish only that portion of the Confidential Information that is required to be disclosed, in the opinion of Receiving Party’s counsel.

 

9.5                                                 Notwithstanding anything set forth in this Clause 9 to the contrary, the obligations of confidentiality shall not apply to the extent that the Party seeking the benefit of the exclusion can demonstrate that the Confidential Information of the other Party is required to be disclosed for the purpose of regulatory submissions, filing or prosecuting any patent applications, in which case the Parties shall consult with each other, to the extent permitted by Applicable Law, prior to any such disclosure being made.

 

9.6                                                 Notwithstanding anything set forth in this Clause 9 to the contrary, the Parties shall be entitled to share the Regulatory Information, either in part or in full, with Third Parties, however only to the extent necessary to achieve the Purposes. The

 

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Parties further agree that such disclosure may not in any way jeopardize the commercial interest of the other Party and the Disclosing Party must carefully take account of the other Party’s commercial interests. If the Third Party with whom a Party wishes to share the Regulatory Information is a Direct Competitor of the other Party, such disclosure shall first be discussed in the JDC in order to find a solution and agree whether and under what conditions the disclosure can take place. The provisions of this Clause 9.6 shall also apply in the event with respect to shareholders of a Party and with respect to any change of ownership or other transaction in which a Direct Competitor may gain access to Confidential Information

 

9.7                                                 In the event that it is necessary for BB to share some of the Clinical Data with a Third Party which is not a Direct Competitor to Zealand, this shall be discussed in the JDC in order to find a solution and agree whether the disclosure can take place. BB further agrees that such disclosure may not in any way jeopardize the commercial interests or securities law obligations of Zealand, that BB must carefully take account of such interests and obligations and that the level of detail may not be more than what is necessary to achieve the Purposes. For the avoidance of doubt, BB agrees that no Clinical Data shall be shared with a Direct Competitor to Zealand until a written approval has been given by Zealand.

 

9.8                                                 The Receiving Party may disclose Confidential Information only to those of its Representatives, Affiliates or sub-contractors who need to know such information for the purposes contemplated by this Agreement. In addition, prior to any disclosure of Confidential Information to any Representatives, Affiliates or sub-contractor, such Representatives, Affiliates and subcontractors shall be made aware of the confidential nature of the Confidential Information and shall execute, or shall already be bound by, a non-disclosure agreement containing terms and conditions consistent with the provisions of this Clause 9.

 

9.9                                                 Irrespective of the confidentiality obligation contained herein, a Party shall be entitled to disclose this Agreement to Third Parties in connection with a due diligence process relating to the Party or as may be required by Applicable Law, provided that such Third Parties, prior to such disclosure, have become subject to a confidentiality agreement on terms offering at least the same protection of confidentiality with regard to Confidential Information as this Clause 9.

 

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10                                                    Publication

 

10.1                                          The Parties acknowledge that in accordance with Clause 6.2, Zealand shall own all Clinical Data from Co-development Activities where Zealand is the sole Sponsor. The Parties shall agree on a plan for the publication of Clinical Data in relation to each Co-development Activity according to which BB shall have the right to publish certain Clinical Data regarding the iLet. The Parties shall agree on the specific terms and condition in the plan; however, BB agrees and acknowledges that such publication may not in any way jeopardize the commercial interests of Zealand and BB must carefully take account of Zealand’s commercial interests. BB also agrees to withhold such publication or presentation if required by Zealand to obtain patent protection.

 

10.2                                          However, notwithstanding the foregoing, Zealand accepts that if no publication has taken place with respect to an iLet/ZP4207 Trial within twelve (12) months after the trial is completed, BB shall be free to publish or present the results of such iLet/ZP4207 Trial, in accordance with the following procedure:

 

At least thirty (30) days prior to submission of a proposed publication, BB shall submit to Zealand for review and comment any proposed publication (“Review Period”). BB will consider any such comments in good faith but is under no obligation to incorporate Zealand’s suggestions. If during the Review Period, Zealand notifies BB that: (i) it desires patent applications to be filed on any Inventions disclosed or contained in the disclosures, BB will defer the proposed publication for a period of up to sixty (60) days, to permit Zealand to file any desired patent applications; and (ii) if the proposed publication contains Zealand Confidential Information as defined in Clause 9, excluding results of the iLet/ZP4207 Trial, and Zealand requests BB to delete such Zealand Confidential Information, BB agrees to delete such Zealand Confidential Information.

 

11                                                    Force Majeure

 

11.1                                          Either Party is entitled to suspend the performance of its obligations under this Agreement if such performance is impeded or causes an unreasonable hardship on the Party due to force majeure, meaning any extraordinary circumstances beyond the reasonable control of such Party.

 

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11.2                                          Any circumstance referred to in Clause 11.1, whether occurring prior to or after entering into this Agreement, only entitles a Party to suspension if its effect on the performance of this Agreement could not have been foreseen at the time of entering into this Agreement.

 

11.3                                          The Party claiming to be affected by any circumstance referred to in Clause 11.1 shall, without undue delay, notify the other Party of the occurrence and of the cessation of such circumstance.

 

12                                                    Representations and Warranties

 

12.1                                          Each Party represents and warrants to the other Party that:

 

12.1.1                                has legal interest in the Proprietary IP existing as of the date hereof and full authority, power and capacity to enter into and carry out its obligations under this Agreement;

 

12.1.2                                all necessary acts have been taken to enable it lawfully to enter into and carry out its obligations under this Agreement; and

 

12.1.3                                when executed, this Agreement will create obligations which are valid and binding on it and enforceable in accordance with its terms.

 

13                                                    Liability

 

13.1                                          If a Party is in breach of any of its obligations under this Agreement, the other Party is entitled to claim damages in accordance with law of the State of New York for losses suffered as a consequence of such breach, however, unless otherwise stated in this Agreement, neither Party shall be liable to the other Party for any consequential or punitive damages or indirect loss whatsoever unless such liability is due to such Party’s gross negligence, wilful misconduct or wilful omission.

 

14                                                    Indemnification

 

14.1                                          BB shall indemnify, defend and hold harmless Zealand, its Affiliates and Representatives from and against any and all losses arising or resulting directly from any 

 

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Third Party claim, action, suit or other proceeding to the extent such losses result from or arise out of:

 

14.1.1                                any material breach of any representation, warranty or covenant made by BB in this Agreement; or

 

14.1.2                                the gross negligence or wilful misconduct of BB in the performance of its tasks and activities under this Agreement, or

 

14.1.3                                the development, manufacture, use, handling and storage of iLets by BB, its Representatives or subcontractors.

 

14.2                                          The indemnification obligations set forth in Clause 14.1 shall not apply to the extent that any loss is the result of a material breach of this Agreement (including a material breach of any representation or warranty) by Zealand or the gross negligence or wilful misconduct of any of its Affiliates and Representatives.

 

14.3                                          Zealand shall indemnify, defend and hold harmless BB, its Affiliates and Representatives from and against any and all losses arising or resulting directly from any Third Party claim, to the extent such losses result from or arise out of:

 

14.3.1                                any material breach of any representation, warranty or covenant made by Zealand in this Agreement; or

 

14.3.2                                the gross negligence or wilful misconduct of Zealand in the performance of its activities under this Agreement, or

 

14.3.3                                the development, manufacture, use, handling and storage of ZP4207 by Zealand, its Representatives or subcontractors.

 

14.4                                          The indemnification obligation set forth in this Clause 14 shall not apply to the extent that any loss is the result of a material breach of this Agreement (including a material breach of any representation or warranty) by BB or the gross negligence or wilful misconduct of any of its Affiliates and Representatives.

 

14.5                                          If a Party intends to claim indemnification under this Clause 14 (“Indemnified Party”), it shall promptly notify the other Party (the “Indemnifying Party”) in writing

 

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of such alleged losses. The Indemnifying Party shall have the right to assume direction and control of the defense thereof with counsel of its choice; provided, however, that the Indemnified Party shall have the right to retain its own counsel at its own expense for any reason.

 

14.6                                          No compromise or settlement of any Third Party claim may be effected by the Indemnifying Party without the Indemnified Party’s written consent (which consent shall not be unreasonably withheld or delayed), unless (a) there is no finding or admission of any violation of law or any violation of the rights of any person and no effect on any other claims that may be made against the Indemnified Party, (b) the sole relief provided is monetary damages that are paid in full by the Indemnifying Party, and (c) the Indemnified Party’s rights under this Agreement are not adversely affected. The Indemnified Party shall have no right to settle any such Third Party claim without the prior written consent of the Indemnifying Party (and any such settlement without the prior written consent of the Indemnifying Party shall relieve the Indemnifying Party of its obligations under this Clause 14), unless (i) there is no finding or admission of any violation of law or any violation of the rights of any person and no effect on any other claims that may be made against the Indemnifying Party, (ii) the sole relief provided is monetary damages that are paid in full by the Indemnified Party, and (iii) the Indemnifying Party’s rights under this Agreement are not adversely affected.

 

14.7                                          Each Party shall obtain and keep in force policies of insurance at its sole cost and expense from reputable insurers of such types (unless self-insured under a program affording comparable coverage), in such amounts and covering such risks as are in accordance with normal and customary industry practice generally for companies similarly situated and engaged in similar business.

 

15                                                    Term and Termination

 

15.1                                          This Agreement is valid from the Effective Date and until terminated in writing by one of the Parties, as provided in Clause 15.2.

 

15.2                                          As both Parties agree that they will be making large long-term investments under this Agreement, the agreement can only be terminated for convenience upon twenty-four (24) months prior written notice to the other Party.

 

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15.3                                          If the Agreement is terminated for convenience, the Parties agree to continue to take account of the other Party’s interests as discussed and agreed under this Agreement, cf. Clauses 3.1.1(ix) and 4.1(i), in relation to the use of the Clinical Data and the Regulatory Information in the future communication etc. with the FDA, EMA and/or any relevant authority.

 

15.4                                          In the event that either Party becomes insolvent, is declared bankrupt or cease its business, the other Party may terminate this Agreement in writing with immediate effect.

 

15.5                                          The Parties acknowledge and agree that the Co-development Activities under this Agreement are performed in the interest of achieving the Purposes and in order to achieve the Purposes as soon as possible. As a consequence hereof, BB hereby gives Zealand a right and license, if BB fails to perform its obligations hereunder and upon Zealand’s reasonable request to all of BB’s Intellectual Property Rights as may be necessary for testing, manufacture, supply and/or use of iLets by Zealand and/or its designees, to the fullest extent BB is permitted to do so under the terms of BB’s licenses to the iLet technology from the Trustees of Boston University. In connection with any such technology transfer and only so long as permitted to do so under the terms of BB’s licenses to the iLet technology from the Trustees of Boston University, upon reasonable notice, BB shall also provide all technical assistance and cooperation by appropriate employees of BB as may reasonably be required in order to test and/or manufacture iLets in the same way as done by BB and shall permit representatives of Zealand and/or its sub-contractors reasonable access to BB facilities, BB manufacturing information and Know-how to learn about the relevant manufacturing and testing processes, methods and technologies. Upon request, Zealand will compensate BB for its assistance in accordance with this Clause 15.5 at reasonable hourly rate(s). In case that BB has used BB’s Affiliates and/or sub-contractors, to the extent possible BB will help facilitate communications with BB Affiliates and/or sub-contractors to help Zealand obtain access to the iLet technology and technical assistance as set forth in this Clause 15.5.

 

15.6                                          If a Party materially breaches any provision of this Agreement, or materially defaults in the performance of an obligation or commitment under this Agreement and fails to remedy the breach or default to the other Party’s reasonable satisfaction within thirty (30) working days after written notification hereof by the other Party (or a longer period if mutually agreed), then the Party not in default or

 

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breach shall have the right to terminate this Agreement with immediate effect. This right of termination is not prejudicial to other legal remedies under this Agreement and applicable law which the Party not in default or breach might have against the other Party with respect to such breach and/or default.

 

15.7                                          Upon termination, for whatever reason, the Parties shall in good faith cooperate in completing any Co-development Activities then being conducted and winding-down this Agreement, including the fulfilment of regulatory requirements.

 

15.8                                          The rights and obligations of BB and Zealand, which by intent or meaning have validity beyond such termination shall survive the termination or expiration of this Agreement.

 

15.9                                          The Parties further agree that Clauses 7 and 8 concerning licenses and Confidential Information, shall survive the termination or expiration of this Agreement provided, however, that to the extent the Agreement is terminated for material breach committed by a Party and not capable of being remedied, the licenses granted shall terminate in relation to the breaching Party.

 

16                                                    Communication

 

16.1                                          The Parties will in good faith coordinate any communication about this Agreement.

 

17                                                    Governing Law

 

17.1                                          This Agreement and the validity thereof shall be governed by and construed in accordance with the laws of the State of New York without regard to its conflict of law rules. Any proceedings shall be brought before the competent courts in and for the State and County of New York, and each Party hereby irrevocably submits to the jurisdiction of such courts and appoints its notice recipient(s) identified below as its agent for service of process in any such proceeding. Notwithstanding the above, either Party may seek emergency or conservatory relief from any court of competent jurisdiction.

 

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18                                                    Notices

 

18.1                                          Any notice to be made under this Agreement shall be provided by letter or by fax:

 

	
To Zealand:
    	
Zealand Pharma A/S
    
	
 
    	
Smedelandsvej 36
    
	
 
    	
DK-2600 Glostrup
    
	
 
    	
Denmark
    
	
 
    	
Att.: Adam Steensberg, CMO
    
	
 
    	
 
    
	
To BB:
    	
Beta Bionics
    
	
 
    	
Business Innovation   Center, Photonics Center
    
	
 
    	
8 Saint Mary’s Street,   Suite 936
    
	
 
    	
Boston, MA 02215-2421
    
	
 
    	
USA
    
	
 
    	
Attn: Edward R.   Damiano, CEO and
    
	
 
    	
Serafina Raskin,   General Counsel
    

 

18.2                                          Upon duly notifying the other Party thereof, a Party may change the designated recipients and/or the contact details set out in Clause 18.1 above.

 

19                                                    Miscellaneous

 

19.1                                          Captions

 

19.1.1                                The captions of this Agreement are for the convenience of reference only and shall not define or limit any of the terms or provisions hereof.

 

19.2                                          Compliance

 

19.2.1                                The Parties shall continuously monitor the compliance of their activities under this Agreement, including the Co-development Activities, with Applicable Law. If and to the extent such activities violate Applicable Law, in particular applicable antitrust or competition law, the Parties will agree on an appropriate amendment of the cooperation set-up and the terms and conditions of this Agreement where necessary.

 

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19.3                                          Export control Issues

 

19.3.1                                Each Party undertakes to comply fully with any rules on export control, including obtaining all required consents, concerning the technology developed, licensed or disclosed as a result of this Agreement, under a Project Agreement or products made using any such technology.

 

19.4                                          Entire Agreement; Rules of Construction

 

19.4.1                                This Agreement represents the entire understanding between the Parties with respect to the subject matter hereof and supersedes any and all prior negotiations, understandings and representations whether written or oral, relating to the subject matter hereof.

 

19.4.2                                The Parties agree that the information considered confidential information under the mutual non-disclosure and confidentiality agreement, Exhibit 2, shall be considered Confidential Information under this Agreement and that the mutual non-disclosure and confidentiality agreement shall cease to be in force as from the Effective Date.

 

19.4.3                                The Parties acknowledge that each Party has read and negotiated the language used in this Agreement. Because all Parties participated in negotiating and drafting this Agreement, no rule of construction will apply to this Agreement, which construes ambiguous language in favour of or against any Party by reason of that Party’s role in drafting this Agreement.

 

19.5                                          Amendments and Waivers

 

19.5.1                                This Agreement may not be changed or modified, in whole or in part, except by supplemental agreement or amendment signed by the Parties. Any Party may waive compliance by any other Party with any of the covenants or conditions of this Agreement, but no waiver will be binding unless executed in writing by the Party making the waiver.

 

19.5.2                                No waiver of any provision of this Agreement will be deemed, or will constitute, a waiver of any other provision, whether or not similar, nor will any waiver constitute 

 

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a continuing waiver. Any consent under this Agreement must be in writing and will be effective only to the extent specifically set forth in such writing.

 

19.6                                          Assignment; Formalities

 

19.6.1                                Subject to the immediately following sentence, this Agreement will be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns, each of which such successors and permitted assigns will be deemed to be a party hereto for all purposes hereof. Unless otherwise expressly set forth in this Agreement, no Party may assign, delegate or otherwise transfer either this Agreement or any of its rights, interests or obligations hereunder without the prior written approval of the other Parties, and any attempt to do so will be null and void, except for (i) an assignment of this Agreement in connection with the sale or transfer of all or substantially all of its business or in connection with a merger or other consolidation with another entity, (ii) an assignment of this Agreement in connection with the sale or transfer of all or substantially all the assets of the business of Zealand to which this Agreement relates (in case of such assignment or delegation by Zealand), and provided that the assignee confirms in writing to be bound by this Agreement and be liable for the assignor’s obligations under this Agreement.

 

19.6.2                                If any provision of this Agreement shall be deemed invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired.

 

19.6.3                                This Agreement is executed in 2 (two) original copies, of which each Party has taken 1 (one), and each of which shall be deemed an original, but which shall both together constitute one and the same document.

 

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Signature Page to Co-development Agreement dated February 10, 2017

 

	
Date: February 10,   2017
    	
Date: February 10,   2017
    
	
 
    	
 
    
	
 
    	
 
    
	
For and on behalf of
    	
For and on behalf of
    
	
Zealand Pharma A/S:
    	
Beta   Bionics, Inc.:
    
	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/ Britt Meelby   Jensen
    	
 
    	
By:
    	
/s/ Edward Damiano
    
	
Name: Britt Meelby   Jensen
    	
Name: Edward   Damiano
    
	
Title: President and   CEO
    	
Title: President and   CEO
    
					

 

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Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00272-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00272-of-00352.parquet"}]]