Portions of this exhibit have been omitted pursuant to a request for confidential treatment pursuant to 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2(b). The omitted portions, marked by [***], have been separately filed with the Securities and...
Exhibit 10.16
EXECUTION VERSION
Portions of this exhibit have been omitted pursuant to a request for confidential treatment pursuant to 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2(b). The omitted portions, marked by [***], have been separately filed with the Securities and Exchange Commission.
EXCLUSIVE LICENSE AND SUPPLY AGREEMENT
by and between
CHIESI FARMACEUTICI S.p.A.
and
PROTALIX LTD.
October 17, 2017
TABLE OF CONTENTS
Section 1. | DEFINITIONS | 1 |
Section 2. | LICENSE | 16 |
2.1 | Exclusive License | 16 |
2.2 | Other License Provisions | 16 |
2.3 | Non-Assertion of Rights | 17 |
2.4 | Sublicensing and Subcontracting | 18 |
2.5 | New Indications | 19 |
2.6 | Patent Challenges | 19 |
2.7 | No Implied License | 20 |
Section 3. | DEVELOPMENT, REGULATORY APPROVALS AND MARKETING | 20 |
3.1 | Development Plan | 20 |
3.2 | Development Responsibilities | 20 |
3.3 | Steering Committee | 21 |
3.4 | Records | 25 |
3.5 | Diligence | 25 |
3.6 | Regulatory Affairs | 25 |
3.7 | Commercialization and Pricing | 31 |
3.8 | Early Access Programs | 31 |
3.9 | Trademarks | 31 |
3.10 | Use of Names | 34 |
3.11 | [***] | 34 |
Section 4. | MANUFACTURE AND SUPPLY. | 34 |
4.1 | Commercial Supply of Licensed Product | 34 |
4.2 | [***] | 34 |
4.3 | Protalix Manufacturing Activities | 35 |
4.4 | Compliance of Third Parties | 35 |
4.5 | Forecasting and Ordering | 35 |
4.6 | Pricing, Invoicing and Supply Price Reconciliation | 36 |
4.7 | Shipping and Delivery | 39 |
4.8 | Certificate of Analysis; Acceptance and Returns | 39 |
4.9 | Product Specification and Manufacturing Changes | 40 |
4.10 | Labeling | 41 |
4.11 | Shortages | 41 |
4.12 | Safety Stock Obligations | 41 |
4.13 | [***] | 42 |
4.14 | Failure to Supply | 43 |
Section 5. | FINANCIAL PROVISIONS | 43 |
5.1 | Effective Date Payment | 43 |
5.2 | Event Milestone Payments | 44 |
5.3 | Development Costs | 46 |
Section 6. | ACCOUNTING AND PROCEDURES FOR PAYMENT | 48 |
6.1 | Periodic Reporting and Reconciliation Payments | 48 |
[***] Redacted pursuant to confidential treatment request.
i |
6.2 | Currency | 49 |
6.3 | Method of Payments | 49 |
6.4 | No Set-Off | 49 |
6.5 | Interest for Late Payments | 49 |
6.6 | Inspection of Records | 50 |
6.7 | Tax Matters | 50 |
Section 7. | PATENTS AND INFRINGEMENT | 51 |
7.1 | Filing and Prosecution | 51 |
7.2 | Correspondence | 52 |
7.3 | Maintenance | 52 |
7.4 | Notices | 52 |
7.5 | Interpretation of Patent Judgments | 52 |
7.6 | Third Party Royalty Obligations | 53 |
7.7 | Third-Party Infringement | 53 |
7.8 | Other Actions by a Third Party | 54 |
7.9 | Patent Marking | 55 |
Section 8. | CONFIDENTIALITY; PUBLICATION | 55 |
8.1 | Confidentiality | 55 |
8.2 | Permitted Disclosures | 55 |
8.3 | Terms of Agreement | 55 |
8.4 | Mandatory Disclosure | 56 |
8.5 | Publication | 57 |
8.6 | Publicity. | 57 |
8.7 | Filing, Registration or Notification of the Agreement | 58 |
Section 9. | REPRESENTATIONS, WARRANTIES AND COVENANTS | 58 |
9.1 | Mutual Representations, Warranties and Covenants | 58 |
9.2 | Additional Representations, Warranties and Covenants of Protalix | 60 |
9.3 | Additional Representation and Warranty of Chiesi | 64 |
9.4 | Disclaimer of Warranty | 64 |
Section 10. | NON-COMPETITION | 64 |
10.1 | Chiesi Non-Compete | 64 |
Section 11. | TERM | 65 |
Section 12. | TERMINATION | 65 |
12.1 | Termination Rights | 65 |
12.2 | Continuing and Accrued Obligations | 66 |
12.3 | Effects of Termination | 67 |
12.4 | Following termination of this Agreement | 68 |
Section 13. | INDEMNIFICATION AND INSURANCE | 68 |
13.1 | Indemnification by Chiesi | 68 |
13.2 | Indemnification by Protalix | 69 |
13.3 | Indemnification of Product Liability Claims | 69 |
13.4 | Defense Procedures; Procedures for Third Party Claims | 69 |
13.5 | Insurance | 70 |
13.6 | Disclaimer of Liability for Consequential Damages | 70 |
13.7 | Sole Remedy | 71 |
[***] Redacted pursuant to confidential treatment request.
ii |
Section 14. | GOVERNING LAW AND JURISDICTION | 71 |
14.1 | Governing Law | 71 |
14.2 | Jurisdiction and Dispute Resolution Process | 71 |
14.3 | Expert Legal Determination | 72 |
Section 15. | MISCELLANEOUS | 73 |
15.1 | Force Majeure | 73 |
15.2 | Severability | 73 |
15.3 | Waivers | 74 |
15.4 | Entire Agreements; Amendments | 74 |
15.5 | Survival | 74 |
15.6 | Assignment; Binding Effect | 74 |
15.7 | Independent Contractor | 75 |
15.8 | Notices | 75 |
15.9 | Third-Party Beneficiaries | 75 |
15.10 | Binding Effect | 75 |
15.11 | Performance by Affiliates | 76 |
15.12 | Counterparts | 76 |
15.13 | Headings | 76 |
15.14 | Equitable Remedies | 76 |
Exhibits
Exhibit A |
– | Protalix Patent Rights |
Exhibit B | – | Third Party Licenses |
Exhibit C | – | Press Release |
Exhibit D | – | Chiesi Anti-Bribery Policy |
Exhibit E | – | Chiesi Code of Ethics and Conduct |
Exhibit F | – | Select Matters |
Schedules
Schedule 3.1 |
– | CONFIDENTIAL – Draft Development Plan |
Schedule 3.7 | – | CONFIDENTIAL – Initial Draft Commercialization Plan |
[***] Redacted pursuant to confidential treatment request.
iii |
EXCLUSIVE LICENSE AND SUPPLY AGREEMENT
This Exclusive License and Supply Agreement (this “Agreement”) dated as of the 17th day of October, 2017 is made by and between Protalix Ltd., a limited liability company incorporated under the laws of Israel with offices located at 2 Snunit Street, Science Park, X.X. Xxx 000, Xxxxxxx 00000, Xxxxxx (“Protalix”), and Chiesi Farmaceutici S.p.A., a company incorporated under the laws of Italy with offices located at Xxxxx X. Xxxxxxx, 00/X - 00000 Xxxxx, Xxxxx (“Chiesi”) (each, a “Party” and collectively, the “Parties”).
WHEREAS, Protalix desires to grant such license to Chiesi.
For purposes of this Agreement, the following definitions shall be applicable:
1.1 “Acquisition” means, with respect to Protalix Parent (i) a completed Business Combination Transaction, unless, immediately following such completed Business Combination Transaction all or substantially all of the individuals and entities who were the beneficial owners of the outstanding voting securities of Protalix Parent immediately prior to such completed Business Combination Transaction beneficially own, directly or indirectly (including through one more holding companies or subsidiaries) at least fifty percent (50%) of the then-outstanding voting securities entitled to vote generally in the election of directors of the corporation or other entity resulting from such completed Business Combination Transaction (including a corporation or other entity that as a result of such transaction owns Protalix Parent or all or substantially all of a Protalix Parent’s assets either directly or through one or more subsidiaries); (ii) the acquisition, directly or indirectly, by any Person (other than Chiesi or its Affiliates) of beneficial ownership of at least fifty percent (50%) or more of the outstanding voting securities of Protalix Parent, or (iii) the acquisition by a Third Party of all or substantially all of the assets of Protalix or Protalix Parent. As used in this Agreement, “voting securities” means any securities of Protalix Parent entitled to vote on the election of directors.
1.2 “Additional Studies” means [***].
[***] Redacted pursuant to confidential treatment request.
1.3 “Affiliate” means any entity directly or indirectly controlled by, controlling, or under common control with, a Party to this Agreement, but only for so long as such control shall continue. For purposes of this definition, “control” (including, with correlative meanings, “controlled by”, “controlling” and “under common control with”) means (a) possession, direct or indirect, of the power to direct or cause direction of the management or policies of an entity (whether through ownership of securities or other ownership interests, by contract or otherwise), or (b) beneficial ownership of at least fifty-percent (50%) of the voting securities or other ownership interest (whether directly or pursuant to any option, warrant or other similar arrangement) or other comparable equity interests of an entity, it being understood and agreed that for purposes of clause (a), neither ownership of voting securities or other ownership interests of an entity nor membership or representation on (if less than half of the members of) an entity’s board of directors shall, by themselves, be presumed to constitute the power to direct or cause direction of the management or policies of such entity. With respect to the definition of Protalix Patent Rights and the definition of Protalix Technology, and with respect to the grant of license rights by Protalix to Chiesi under Section 2 in respect of such Protalix Patent Rights and Protalix Technology, “Affiliates” of Protalix shall exclude any Third Party that becomes an Affiliate due to such Third Party’s acquisition of Protalix.
1.4 “Alliance Manager” shall have the meaning assigned to it in Section 3.3(a).
1.5 “Annual Cap” shall have the meaning assigned to it in Section 5.3(c).
1.6 “Annual Net Sales” means Net Sales for any Commercial Year.
1.7 “Applicable Rate” shall have the meaning assigned to it in Section 4.6(f).
1.8 “Audit” shall have the meaning assigned to it in Section 6.6.
1.9 “Average Sales Price” shall have the meaning assigned to it in Section 4.6(e).
1.10 “Business Combination Transaction” means any tender or exchange offer to Protalix Parent’s stockholders, or any other offer or proposal to Protalix Parent or its stockholders for any merger, consolidation, restructuring, recapitalization or similar transaction with or involving Protalix Parent.
1.11 “Business Day” means a day other than a Saturday, Sunday, or bank or other public holiday in New York, New York, Parma, Italy or Carmiel, Israel.
1.12 “Buy-Back Payment” shall have the meaning assigned to it in Section 12.1(d).
1.13 “Calendar Quarter” means each of the four (4) three (3) month periods commencing on January 1 of any Calendar Year and ending on (respectively) March 31, June 30, September 30, and December 31 of such Calendar Year.
1.14 “Calendar Year” means the twelve (12) month period commencing on January 1 and ending on December 31 of any calendar year; provided that the first Calendar Year of the Term, shall commence on the Effective Date and end on December 31 of such calendar year and the last Calendar Year of the Term shall end on the date of expiration or termination of this Agreement.
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1.15 “Change of Control” means the occurrence of any of the following: (a) any consolidation or merger of a Party with or into any Third Party, or any other corporate reorganization involving a Third Party, in which those persons or entities that are stockholders of such Party immediately prior to such consolidation, merger or reorganization own less than fifty percent (50%) of the surviving entity’s voting power immediately after such consolidation, merger or reorganization; (b) a change in the legal or beneficial ownership of fifty percent (50%) or more of the voting securities of any Party (whether in a single transaction or series of related transactions) where, immediately after giving effect to such change, the legal or beneficial owner of more than fifty percent (50%) of the voting securities of such Party is a Third Party; or (c) the sale, transfer, lease, license or other disposition of all or substantially all of a Party’s assets related to this Agreement in one or a series of related transactions to a Third Party.
1.16 “Chiesi Chair” means one of the Chiesi representatives on the Steering Committee designated by Chiesi as Chiesi’s chair for Steering Committee Meetings.
1.17 “Chiesi Confidential Information” means all information or data of a proprietary or confidential nature relating to the Commercialization of the Licensed Product in the Field in the Territory, as well as any other information regarding the business, operations, Technology and Commercialization activities of Chiesi, whether in oral, written, graphic, machine-readable form, or any other form, (provided that data and information disclosed orally or visually are confirmed in writing by Chiesi within thirty (30) days after the date of such disclosure), disclosed and/or made available by or on behalf of Chiesi to Protalix, Protalix’s Affiliates, and its and their respective directors, officers, employees, consultants, contractors and agents or otherwise acquired by any such Persons as a result of or in connection with this Agreement and/or the Parties’ discussions (whether prior to the execution hereof or thereafter). Notwithstanding the foregoing, unmarked information and un-confirmed information will be considered Chiesi Confidential Information under this Agreement if a reasonable person familiar with the Licensed Product and given the nature of information and the circumstances of disclosure would consider such information to be confidential. Such information shall not be considered to be Chiesi Confidential Information to the extent that such information is: (a) as of the date of disclosure known to Protalix or its Affiliates, as demonstrable in any tangible medium in existence at the time of disclosure; or (b) wholly disclosed in published literature, or otherwise is or becomes generally known to the public through no breach by Protalix of this Agreement; or (c) obtained by Protalix or its Affiliates from a Third Party free from any obligation of confidentiality to Chiesi; or (d) independently developed by Protalix or its Affiliates without use of or reference to the Chiesi Confidential Information.
1.18 “Commercial Medical Affairs and Pharmacovigilance” has the meaning assigned to it in Section 3.6(d)(iv).
1.19 “Commercial Quarter” means each of the four (4) consecutive three (3) month periods of each Commercial Year, with the first Commercial Quarter commencing on first day of such Commercial Year (other than the first Commercial Quarter of the first Commercial Year, which shall commence on the first day of such Commercial Year, but end on the last day of the subsequent Calendar Quarter, i.e., including the period from Launch through the end of the subsequent full Calendar Quarter) and the last Commercial Quarter ending on the last day of such Commercial Year.
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1.20 “Commercial Year” means (a) for the sole purpose of calculating whether an Event Milestone under Section 5.2 has been achieved, the twelve (12) month period commencing on either (i) the Launch date, or (ii) January 1 of the subsequent Calendar Year, if during such first twelve (12) month period starting from the Launch date, Event Milestone 2 has not been achieved; or (b) for all other purposes, the period commencing on the Launch Date and ending twelve (12) months after the first day of the subsequent Calendar Quarter, and (in each case (a) and (b)) any subsequent twelve (12) month period.
1.21 “Commercialization” means any and all activities directed to and including marketing, promoting, advertising, distributing, disposing, offering for sale, selling, Labelling and Packaging, final product release testing, exporting and importing of a Licensed Product for commercial sale (to the extent applicable). When used as a verb, “Commercialize” means to engage in Commercialization.
1.22 “Commercialization Plan” shall have the meaning set forth in Section 3.7(a).
1.23 “Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party with respect to the objective that is the subject of such efforts, reasonable, good faith efforts and resources to accomplish such objective that such Party would normally use to accomplish a similar objective under similar circumstances, it being understood and agreed that with respect to the Commercialization of the Licensed Product in the Field in the Territory by Chiesi, such efforts shall be similar to those efforts and resources consistent with the usual practice of Chiesi in pursuing the Commercialization of drug products owned by it or to which it otherwise has rights that are of similar market potential as a Licensed Product in the Territory, taking into account all relevant factors, including the orphan drug status (if any) of the Licensed Product and other regulatory matters, safety and efficacy matters, product labeling or anticipated labeling, pricing, present and future market potential, past performance of the Licensed Product, past performance of Chiesi’s own drug products that are of similar market potential (taking into account that the Licensed Product is intended for the treatment of a rare disease), financial return [***], medical and clinical considerations, present and future regulatory environment and competitive market conditions, all as measured by the facts and circumstances at the time such efforts are due. It is anticipated that the level of effort constituting Commercially Reasonable Efforts may change over time. With respect to the Commercialization of the Licensed Product in the Field in the Territory by Chiesi, such efforts shall include [***].
1.24 “Competing Product” means [***].
1.25 “Compliance Records” shall have the meaning assigned to it in Section 6.6.
1.26 “Compound” means (a) a plant cell-expressed recombinant form of human alpha-Galactosidase-A, including pegunigalsidase alfa (PRX-102) and (b) any analogs, derivatives and variants thereof.
[***] Redacted pursuant to confidential treatment request.
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1.27 “Confidential Information” means the Protalix Confidential Information or the Chiesi Confidential Information, as applicable.
1.28 “Control” or “Controlled” means, with respect to any compound, material, information, or intellectual property right, that a Party owns or has a license to use, commercialize, manufacture, market, distribute or sell, and has the ability to grant to the other Party access and/or a license or a sublicense (as applicable under this Agreement) to, such compound, material, information, or intellectual property right as provided for herein without violating (a) the terms of any agreement or other arrangements with any Third Party existing before or after the Effective Date or (b) any Law applicable to such license or sublicense.
1.29 “Country” means any generally recognized sovereign entity.
1.30 “CMC” means, in respect of a regulatory filing, “Chemistry, Manufacturing, and Controls”.
1.31 “Deferred Milestone” shall have the meaning assigned to it in Section 5.2(d).
1.32 “Development” or “Develop” means conducting non-clinical (including pre-clinical studies and CMC activities) and clinical trials (including the Ongoing Clinical Studies and the Required Studies), collecting, validating and analyzing pre-clinical and clinical trial data, preparing and submitting any regulatory filings prior to obtaining Regulatory Approvals, preparing the clinical and Manufacturing portions of any regulatory filing seeking Regulatory Approval (including portions relating to CMC), and regulatory affairs related to the foregoing. When used as a verb, “Develop” means to engage in Development. For clarity, Development does not include any regulatory affairs or commitments in respect of the Licensed Product in a Country following Regulatory Approval for such Licensed Product in such Country, or any of the foregoing in connection therewith. When used as a verb, “Developing” means to engage in Development.
1.33 “Development Costs” means Protalix’s fully-loaded costs related to the Development of (and obtaining Regulatory Approval from the EMA for) the Licensed Product, excluding Patent Costs, and including any (a) direct, out-of-pocket costs and expenses, including clinical or medical grants, clinical laboratory fees, positive controls and the cost of pre-clinical and clinical studies conducted and services provided by contract research organizations, and (b) the conduct of clinical studies, including costs and expenses associated with data management, statistical designs and studies, document preparation and any and all other costs and expenses associated with preparing and submitting regulatory filings, obtaining (including, solely with respect to approvals granted upon specific conditions requiring the conduct of specified additional required studies to maintain such granted Regulatory Approval, maintaining) Regulatory Approval for the Licensed Product, and the conduct of the clinical Development program for the Licensed Product, including as set out in the Development Plan [***].
[***] Redacted pursuant to confidential treatment request.
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1.34 “Development Costs Cap” shall have the meaning assigned to it in Section 5.3(b).
1.35 “Development Plan” shall have the meaning assigned to it in Section 3.1.
1.36 “Direct Sublicensee Revenue A” means all amounts paid or due from Sublicensees to Chiesi or its Affiliates [***].
1.37 “Direct Sublicensee Revenue B” means all amounts paid or due from Sublicensees to Chiesi or its [***].
1.38 “Drug Substance” means the Compound component of a pharmaceutical drug product.
1.39 “Drug Product” means unlabeled vials of Licensed Product [***], but not Labeling and Packaging.
1.40 “Early Access Program” means any program to provide patients with the Licensed Product prior to Regulatory Approval and prior to Launch in any Country in the Territory. Early Access Programs include, for example, any named patient programs in the EU and compassionate use or other expanded access programs in other Countries in the Territory.
1.41 “Effective Date” means the date of this Agreement.
1.42 “EMA” means the European Medicine Agency or any successor agency thereto.
1.43 “European Economic Area” means the member states of the EU together with Iceland, Norway and Liechtenstein.
1.44 “European Union” or “EU” means the Countries that are members of the European Union as of the Effective Date or that become members of the European Union thereafter, and includes, for the avoidance of doubt, any Countries that as of the Effective Date, or at any point during the Term thereafter, cease being members of the European Union, but that remain subject to any applicable Law of the EU.
1.45 “Event Milestone” shall have the meaning set forth in Section 5.2(a).
1.46 “Event Milestone 1a”, “Event Milestone 1b”, “Event Milestone 2”, “Event Milestone 3”, “Event Milestone 4”, “Event Milestone 5”, “Event Milestone 6”, “Event Milestone 7”, “Event Milestone 8”, “Event Milestone 9”, and “Event Milestone 10” shall each have the meanings assigned to those terms in Section 5.2(a).
[***] Redacted pursuant to confidential treatment request.
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1.47 “Event Milestone 1a Studies” means [***].
1.48 “Event Milestone Payments” means the amounts set forth in Section 5.2(a) opposite the respective Event Milestones, subject to Sections 5.2(b), 5.2(c) and 5.2(d).
1.49 “Facility” means, as applicable, Protalix’s Manufacturing facility and such other facilities used by Protalix (or its Affiliates, licensees, sublicensees or designees [***]) in the Manufacture or storage of (a) Drug Substance, (b) Drug Product or (c) materials utilized in the Manufacture of Drug Substance or Drug Product.
1.50 “Failure to Supply” shall have the meaning assigned to it in Section 4.14(a).
1.51 “Field” means enzyme replacement therapy for the treatment of Fabry Disease.
1.52 [***].
1.53 [***].
1.54 “Financial Records” shall have the meaning assigned to it in Section 6.6.
1.55 “Force Majeure Event” shall have the meaning assigned to it in Section 15.1.
1.56 “Forecast” shall have the meaning assigned to it in Section 4.5(a).
1.57 “FTE” shall mean one or more persons allocated on a full-time basis to the Commercialization of the Licensed Product in the Territory (both at a headquarter and country level, and including, for clarity, any product specialists, key asset managers, sales representatives, medical science liaisons, or medical, regulatory, market access and marketing personnel).
1.58 “GAAP” means United States generally accepted accounting principles consistently applied.
1.59 “Good Manufacturing Practices” or “GMP” means all applicable Good Manufacturing Practices including, (i) the applicable part of quality assurance to ensure that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use, as defined in European Commission Directive 2003/94/EC laying down the principals and guidelines of good manufacturing practice, (ii) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Sections 210 and 211, (iii) the Rules Governing Medicinal Products in the European Community, Volume IV Good Manufacturing Practice for Medicinal Products, (iv) the principles detailed in the ICH Q7A guidelines, and (v) the equivalent Laws in any relevant Country, each as may be amended and applicable from time to time.
[***] Redacted pursuant to confidential treatment request.
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1.60 “Governmental Authority” means any court, agency, department, authority or other instrumentality of any national, supra national, state, county, city or other political subdivision.
1.61 “ICC Rules” shall have the meaning assigned to it in Section 14.2(b).
1.62 “Included Sublicensee Revenue” means, with respect to a Licensed [***].
1.63 “IND” means (i) an investigational new drug application as defined in 21 CFR 312.3 and all amendments and supplements thereto filed with the FDA or (ii) an equivalent application filed with any equivalent foreign agency or Governmental Authority including all documents, data and other information concerning use of an investigational pharmaceutical product which are necessary for gaining authorization from such equivalent foreign agency or Governmental Authority to ship and use such product in clinical investigations.
1.64 “Indemnified Party” shall have the meaning assigned to it in Section 13.4(a).
1.65 “Indemnifying Party” shall have the meaning assigned to it in Section 13.4(a).
1.66 “Initial Forecast” shall have the meaning assigned to it in Section 4.5(a).
1.67 “Initiation” means, with respect to the Phase 1 Clinical Trial for a New Use, the first study-specific screening activities.
1.68 “Joint Legal Counsel” shall have the meaning assigned to it in Section 14.3(a).
1.69 “Joint Legal Opinion” shall have the meaning assigned to it in Section 14.3(a).
1.70 “Label” means, with respect to a Licensed Product, all labels and other written, printed, or graphic matter (a) on the Licensed Product containers or wrappers, or (b) accompanying the Licensed Product.
1.71 “Labeling and Packaging” means the final product labeling and packaging of the Drug Product, including materials to be inserted such as patient inserts, patient medication guides, professional inserts and any other written, printed or graphic materials accompanying the Drug Product.
1.72 “Launch” with respect to any Country or jurisdiction in the Territory, means the first shipment of a Licensed Product in commercial quantities for commercial sale by Chiesi, its Affiliates or its Sublicensees to a Third Party in such Country or jurisdiction in the Territory after receipt of the first Regulatory Approval (and Price Approval and Governmental Authority or Third Party reimbursement approval where applicable and required) for such Licensed Product in such Country. “Launched”, when used in respect of the Licensed Product in a Country, means that the Launch of such Licensed Product has already occurred in such Country.
[***] Redacted pursuant to confidential treatment request.
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1.73 “Laws” means all laws, statutes, rules, regulations, codes, administrative or judicial orders, judgments, decrees, injunctions and/or ordinances of any Governmental Authority, and common law or other legal requirements of any kind, whether currently in existence or hereafter promulgated, enacted, adopted or amended.
1.74 “Licensed Product” means any finished dosage form of a drug product that contains the Drug Substance and either: (a) the manufacture, sale, offer for sale, importation, or use of which (i) would, absent the license granted by Protalix to Chiesi herein, infringe at least one Valid Claim of a Protalix Patent Right or (ii) embodies, incorporates or uses Protalix Technology, or (b) is supplied by Protalix to Chiesi under this Agreement as Drug Product or, after the [***] (subject to Chiesi performing Labeling and Packaging in respect of such Drug Product and, after [***].
1.75 “Long Range Forecast” shall have the meaning assigned to it in Section 4.5(b).
1.76 “Manufacture” or “Manufacturing” means all activities related to the manufacturing of the Drug Substance, Drug Product or Licensed Product (as applicable), and/or any ingredient thereof, including manufacturing for clinical use or commercial sale, in-process and finished product testing, the final product labeling and packaging of the product, release of product, quality assurance activities related to manufacturing and release of product and ongoing stability tests and regulatory activities related to any of the foregoing.
1.77 “Manufacturing Certificate of Analysis” shall have the meaning assigned to it in Section 4.8(a)(i).
1.78 “Material Change” shall have the meaning assigned to it in Section 7.2(a).
1.79 “Maximum Order Quantity” shall have the meaning assigned to it in Section 4.6(i).
1.80 “Minimum Batch Size” means the minimum batch size for Drug Product (as may be updated by Protalix from time to time, in its sole discretion for any variance of [***] or less, and only with Chiesi’s prior consent for any variance of more than [****], such consent not to be unreasonably withheld, conditioned or delayed), which currently is [***] of Licensed Product.
1.81 “Minimum Payment” shall have the meaning assigned to it in Section 4.6(h).
1.82 “NDA” means a New Drug Application or Biologics License Application (as applicable) filed with the United States Food and Drug Administration (or any successor agency thereto) with respect to a drug product or an analogous application or filing with any Regulatory Authority outside of the United States (including any supra-national entity such as the European Union) for the purpose of obtaining approval to market and sell a drug product in such jurisdiction.
[***] Redacted pursuant to confidential treatment request.
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1.83 “Negotiation Period” means the ninety (90)-day period beginning on the date as set forth in Section 2.5(b).
1.84 “Net Sales” means, with respect to a Licensed Product, the gross amounts invoiced by Chiesi or its Affiliates for sale of Licensed Product, less the following customary deductions, determined in accordance with GAAP and standard internal policies and procedures and accounting standards and methods consistently applied throughout Chiesi’s organization, to the extent specifically and solely allocated to such Licensed Product and actually taken, paid, accrued, allowed, included or allocated: [***].
1.85 “New Indication” means a distinct type of disease or medical condition in humans to which a Licensed Product is directed that is not the Field.
1.86 [***].
1.87 “New Use” shall have the meaning assigned to it in Section 2.5(a).
1.88 “Notice of Non-Conformance” shall have the meaning assigned to it in Section 4.8(a)(i).
1.89 “Ongoing Clinical Study” means [***].
1.90 “Other Patent Challenge” shall have the meaning assigned to it in Section 2.6(c).
1.91 “Other Sublicensee Revenue” means [***].
1.92 “Other Sublicensee Revenue Payment” [***].
1.93 “Outside of the Scope Product” shall have the meaning assigned to it in Section 7.2(a).
1.94 “Patent Application” means any application for a Patent.
1.95 “Patent Costs” means any and all costs and expenses incurred by Protalix in respect of the exercise of any of its rights and obligations under Section 7 of this Agreement.
1.96 “Patent Rights” means Patents and Patent Applications.
1.97 “Patents” means issued patents, whether domestic or foreign, including all continuations, continuations-in-part, divisions, provisionals and renewals, and letters of patent granted with respect to any of the foregoing, patents of addition, supplementary protection certificates, registration or confirmation patents and all reissues, re-examination and extensions thereof.
1.98 “Patent Ownership Challenge” shall have the meaning assigned to it in Section 2.6(a).
[***] Redacted pursuant to confidential treatment request.
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1.99 “PCT” means the Patent Cooperation Treaty, opened for signature June 19, 1970, 28 U.S.T. 7645.
1.100 “Person” means an individual, corporation, partnership, company, joint venture, unincorporated organization, limited liability company or partnership, sole proprietorship, association, bank, trust company or trust, whether or not legal entities, or any Governmental Authority.
1.101 “Pharmacovigilance Agreement” shall have the meaning assigned to it in Section 3.6(f).
1.102 “Phase 1 Clinical Trial” means a human clinical trial of the initial Licensed Product that would satisfy the requirements of 21 C.F.R. § 312.21(a) or any other equivalent foreign requirements.
1.103 “Post-Approval Studies” means any pre-clinical or clinical studies for a Licensed Product (or for the Drug Substance therein) commenced after receipt of Regulatory Approval for such Licensed Product, that are not Required Studies.
1.104 “Price” means the price to be charged by Protalix and paid by Chiesi for Drug Product [***] sold by Protalix to Chiesi under this Agreement as specifically determined in accordance with Section 4.6.
1.105 “Price Approval” means, in any Country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, drug products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).
1.106 “Product Specifications” means those Manufacturing, performance, quality - control release, and other specifications for Drug Substance, Drug Product or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.
1.107 “Protalix Chair” means one of the Protalix representatives on the Steering Committee designated by Protalix as Protalix’s chair for Steering Committee Meetings.
[***] Redacted pursuant to confidential treatment request.
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1.108 “Protalix Confidential Information” means all information or data of a proprietary or confidential nature relating to the Protalix Technology, Compound or Licensed Product as well as any other information, including proprietary information and materials, regarding the business, operations, research, Technology and the supply, Manufacture, Development and Commercialization activities of Protalix, whether in oral, written, graphic, machine-readable form, or any other form, (provided that data and information disclosed orally or visually are confirmed in writing by Protalix within thirty (30) days after the date of such disclosure), disclosed and/or made available by or on behalf of Protalix to Chiesi, Chiesi’s Affiliates, and its and their respective directors, officers, employees, consultants, contractors and agents or otherwise acquired by any such Persons as a result of or in connection with this Agreement and/or the Parties’ discussions (whether prior to the execution hereof or thereafter). Notwithstanding the foregoing, unmarked information and un-confirmed information will be considered Protalix Confidential Information under this Agreement if a reasonable person familiar with the Licensed Product and given the nature of information and the circumstances of disclosure would consider such information to be confidential. Such information shall not be considered to be Protalix Confidential Information to the extent that such information is: (a) as of the date of disclosure known to Chiesi or its Affiliates, as demonstrable in any tangible medium in existence at the time of disclosure; or (b) wholly disclosed in published literature, or otherwise is or becomes generally known to the public through no breach by Chiesi of this Agreement; or (c) obtained by Chiesi or its Affiliates from a Third Party free from any obligation of confidentiality to Protalix; or (d) independently developed by Chiesi or its Affiliates without use of or reference to the Protalix Confidential Information.
1.109 “Protalix Parent” means Protalix Biotherapeutics, Inc.
1.110 “Protalix Patent Rights” means all Patent Rights owned or otherwise Controlled by Protalix or any of its Affiliates as of the Effective Date or at any time during the Term that claim the composition of matter, manufacture or use of the Compound, Drug Substance or a drug product that contains Drug Substance, including the Patent Rights listed in Exhibit A.
1.111 “Protalix System Patent Rights” means Protalix Patent Rights that relate primarily to the System.
1.112 “Protalix Trademarks” shall have the meaning assigned to it in Section 3.10.
1.113 “Protalix Technology” means any Technology owned or otherwise Controlled by Protalix or any of its Affiliates as of the Effective Date or at any time during the Term that is necessary or useful for the Development, Manufacture, use or Commercialization of Compound, Drug Substance or a drug product that contains Drug Substance, including the System.
1.114 “Purchase Order” shall have the meaning assigned to it in Section 4.5(a).
1.115 “Quality Agreement” means the Quality Agreement(s) to be entered into between Protalix and Chiesi (which the Parties shall use Commercially Reasonable Efforts to finalize within one hundred and eighty (180) days from the Effective Date) with respect to the Drug Product (and, after the [***].
1.116 [***]
1.117 [***]
[***] Redacted pursuant to confidential treatment request.
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1.118 “Reconciliation Adjustment” shall have the meaning assigned to it in Section 4.6(h).
1.119 “Referent Person” shall have the meaning assigned to it in Section 8.5.
1.120 “Registry” shall mean an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes and meets the requirements of the applicable Regulatory Authority.
1.121 “Reimbursed Party” shall have the meaning assigned to it in Section 5.3(h).
1.122 “Reimbursing Party” shall have the meaning assigned to it in Section 5.3(h).
1.123 “Regulatory Approval” means any and all approvals, with respect to any Country, or authorizations (other than Price Approvals) of a Regulatory Authority, that are necessary for the commercial Manufacture, distribution, use, marketing or sale of a drug product in such Country, including but not limited to any NDAs.
1.124 “Regulatory Authority” means, in respect of a particular Country or jurisdiction, the Governmental Authority having responsibility for granting Regulatory Approvals in such Country or jurisdiction.
1.125 “Regulatory Exclusivity” means any rights or protections which are recognized, afforded or granted by a Regulatory Authority in any Country or region of the Territory, in association with the Regulatory Approval of a Licensed Product, providing such Licensed Product: (a) a period of marketing exclusivity, during which the Regulatory Authority recognizing, affording or granting such marketing exclusivity will refrain from either reviewing or approving a marketing authorization application or similar regulatory submission, submitted by a Person other than Chiesi, its Affiliates or its Sublicensees seeking to market a drug product in which the Drug Substance is the primary ingredient, or during which such an application or submission may be reviewed or approved by a Regulatory Authority, but the product may not be placed on the market or (b) a period of data exclusivity, during which a Person, other than Chiesi, its Affiliates or its Sublicensees, seeking to market a drug product in which the Drug Substance is the primary ingredient, is precluded from either referencing or relying upon a Licensed Product’s clinical dossier or relying on previous findings of safety or effectiveness with respect to a Licensed Product to support the submission, review or approval of a marketing authorization application or similar regulatory submission before the applicable Regulatory Authority. Regulatory Exclusivity shall include rights conferred in the European Union/European Economic Area pursuant to Section 10.1 of Directive 2001/EC/83 or section 14.11 of Regulation (EC) No. 726/2004.
1.126 [***].
[***] Redacted pursuant to confidential treatment request.
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1.127 “Required Registry” shall have the meaning assigned to it in Section 3.2(c).
1.128 [***].
1.129 [***].
1.130 [***].
1.131 [****].
1.132 “Safety Stock” shall have the meaning assigned to it in Section 4.12(a).
1.133 “Safety Stock Amount” shall have the meaning assigned to it in Section 4.12(a).
1.134 “Shortage” shall have the meaning assigned to it in Section 4.11.
1.135 [***].
1.136 “Standby License” shall have the meaning assigned to in Section 2.2(d).
1.137 “Steering Committee” shall have the meaning assigned to it in Section 3.3(a).
1.138 “Steering Committee Meeting” shall have the meaning assigned to it in Section 3.3(b).
1.139 “Sublicense” means the grant by Chiesi of a sublicense under, or an agreement of Chiesi not to assert, any of the rights licensed by Protalix to Chiesi pursuant to Section 2.1.
1.140 “Sublicensee” means a Third Party to whom Chiesi has granted a Sublicense in accordance with the terms and conditions set forth herein.
1.141 “Sublicensee Net Sales” means, with respect to a Licensed Product, the gross amounts invoiced by Sublicensees for sale of Licensed Product, less the following customary deductions, determined in accordance with GAAP and standard internal policies and procedures and accounting standards and methods consistently applied throughout such Sublicensee’s organization, to the extent specifically and solely allocated to such Licensed Product and actually taken, paid, accrued, allowed, included or allocated: [***].
[***] Redacted pursuant to confidential treatment request.
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1.142 “Sublicense Threshold” means an amount, where [***].
1.144 “System” means Protalix’s proprietary protein expression system, ProCellEx™.
1.145 “Technology” means proprietary materials, technology, data, results and non-public technical, scientific and clinical information, in any tangible or intangible form, including know-how, expertise, trade secrets, practices, techniques, methods, processes, developments, specifications, formulations, formulae, including any intellectual property rights embodying any of the foregoing, but excluding Patent Rights.
1.146 “Term” shall have the meaning assigned to it in Section 11.
1.147 “Territory” means the entire world, excluding the United States (and its territories and possessions).
1.148 “Third Party” means any Person other than Chiesi, Protalix, or any of their respective Affiliates.
1.149 “Third Party Claim” shall have the meaning assigned to it in Section 13.4(a).
1.150 “Third Party License” means each license agreement between Protalix and a Third Party pursuant to which or from which Protalix licenses Protalix Patent Rights or Protalix Technology, including those listed on Exhibit B.
1.151 “Top 5 EU” means each of the following Countries: [***].
1.152 “United States” or “U.S.” means the United States of America, its territories and possessions.
1.153 [***].
1.154 “Valid Claim” means (a) a claim of an issued and unexpired Patent (including the term of any patent term extension, supplemental protection certificate, renewal or other extension) which has not been held unpatentable, invalid or unenforceable in a final decision of a court or other Governmental Authority of competent jurisdiction from which no appeal may be or has been taken, and which has not been admitted to be invalid or unenforceable through reissue, re-examination or disclaimer; or (b) a claim of a Patent Application, which claim has been pending less than seven (7) years from the original priority date of such claim in a given jurisdiction, unless or until such claim thereafter issues as a claim of an issued Patent (from and after which time the same shall be deemed a Valid Claim subject to paragraph (a) above).
1.155 “Yearly Reconciliation” shall have the meaning assigned to it in Section 4.6(h).
[***] Redacted pursuant to confidential treatment request.
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(a) under the Protalix Patent Rights to (i) Commercialize the Licensed Product in the Field in the Territory, (ii) on a non-exclusive basis, following the completion of [***] (if any), carry out [***] activities with respect to the Licensed Product in the Field in the Territory, and (iii) seek and obtain Regulatory Approval, Price Approval and Governmental Authority or Third Party reimbursement approval (where applicable and required) for the Licensed Product in the Field in the Territory (in each case, in accordance with Section 3); and
(b) to use Protalix Technology as necessary to (i) seek and obtain Regulatory Approval, Price Approval and Governmental Authority or Third Party reimbursement approval (where applicable and required) for the Licensed Product in the Field in the Territory, including following the transfer contemplated by Section 3.6(c), to prepare and submit any regulatory filings and communicate with Regulatory Authorities with respect to the Licensed Product in the Field in the Territory (in each case, in accordance with Section 3), (ii) following completion of the transfers contemplated by Section 3.6(d)(iv), on a non-exclusive basis, carry out its Commercial Medical Affairs and Pharmacovigilance responsibilities, (iii) on a non-exclusive basis, following the completion of [***] (if any), carry out [***] activities with respect to the Licensed Product in the Field in the Territory, and (iv) Commercialize the Licensed Product in the Field in the Territory.
(a) The licenses granted to Chiesi pursuant to Section 2.1 shall be co-exclusive with Protalix to the extent it is necessary or useful for Protalix to perform its obligations under this Agreement.
[***] Redacted pursuant to confidential treatment request.
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(b) The Parties expressly acknowledge and agree that, the exclusivity grant in favor of Chiesi in Section 2.1 shall not be construed as limiting (i) Protalix’s right to Develop or Manufacture the Licensed Product (or the Compound, Drug Substance or Drug Product for use in the Licensed Product), (ii) Protalix’s right to Commercialize the Licensed Product outside of the Field or outside of the Territory, or (iii) any of Protalix’s rights in respect of the Licensed Product (including its rights under the Protalix Patent Rights) outside of the Territory.
(c) For purposes of clarity, Chiesi acknowledges that in the event Protalix does not have exclusive rights to Protalix Patent Rights or Protalix Technology licensed or obtained by Protalix from Third Parties vis à vis the Third Party licensor, Chiesi’s rights to such Protalix Patent Rights or Protalix Technology under the sublicenses granted under Section 2.1 would not be exclusive vis à vis the Third Party licensor or its licensees (but would have the same scope of rights licensed or obtained by Protalix thereunder to the extent such rights are granted to Chiesi by Protalix hereunder and permitted to be granted by Protalix to Chiesi under such Third Party License).
(d) Protalix shall use Commercially Reasonable Efforts to obtain an agreement between Chiesi and such Third Party licensor pursuant to which, in the event that the applicable Third Party License is terminated for any reason, such Third Party licensor would xxxxx Xxxxxx a license to the Protalix Patent Rights or Protalix Technology (as applicable) that Protalix has licensed from that Third Party licensor to the extent included in, and solely for the purpose of, the license granted to Chiesi hereunder (each such agreement, a “Standby License”).
(a) During the Term, Chiesi shall not, and shall cause its Affiliates not to, assert any Patent Rights or Technology owned or Controlled by Chiesi and its Affiliates against Protalix, its Affiliates or permitted sublicensees for (i) exercising its rights and performing its obligations pursuant to this Agreement or (ii) using, making, having made, selling, offering for sale, supplying, causing to be supplied and importing the Drug Substance or Licensed Product outside the Territory.
(b) The covenant not to xxx in Section 2.3(a) shall inure to the benefit of any permitted assignee of this Agreement pursuant to Section 15.6.
(c) During the Term, Protalix shall not, and shall cause its Affiliates not to, assert any Protalix System Patent Rights owned or Controlled by Protalix and its Affiliates against Chiesi, its Affiliates or permitted Sublicensees for exercising its rights and performing its obligations pursuant to and in accordance with this Agreement and the license granted herein. Such covenant not to xxx shall inure to the benefit of any permitted assignee of this Agreement pursuant to Section 15.6.
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2.4 Sublicensing and Subcontracting.
(a) Chiesi may only grant Sublicenses to (i) its Affiliates, which Sublicense shall automatically terminate when such Affiliate ceases to be an Affiliate of Chiesi, and (ii) reputable Third Parties [***].
(b) Each Sublicense granted by Chiesi pursuant to Section 2.4(a) shall be subject and subordinate to the terms and conditions of this Agreement and shall contain terms and conditions consistent with, and at least as protective of Protalix, the Protalix Patent Rights, the Protalix Technology and the Protalix Confidential Information as, those set forth in this Agreement, and shall not in any way diminish, reduce or eliminate any of Chiesi’s obligations under this Agreement. Without limiting the foregoing, each Sublicense agreement with permitted Sublicensees shall contain the following provisions: (i) a requirement that such Sublicensee submit applicable sales or other reports consistent with the requirements set forth in Section 6.1, (ii) a requirement to keep books and records, and permit Protalix to audit (either directly or through an independent auditor) such books and records, consistent with the requirement set forth in Section 6.6, (iii) a requirement that such Sublicensee comply with the confidentiality and non-use provisions of Section 8 with respect to both Parties’ Confidential Information, (iv) a requirement to comply with all other applicable terms of this Agreement, and (v) a provision prohibiting such Sublicensee from further sublicensing the rights granted to it under the Sublicense. Chiesi shall provide Protalix with a copy of each such Sublicense agreement within thirty (30) days after the execution thereof; provided that Chiesi may redact confidential information from such Sublicense agreement that is not reasonably necessary to demonstrate Chiesi’s compliance with the obligations set forth in this Agreement, including this Section 2.4(b).
(i) Right to Subcontract. Each Party may, subject to Section 4.3 and Section 8, subcontract its rights and obligations under this Agreement to an Affiliate or Third Party as it would in the normal course of its business without the prior written consent of the other Party, except that Chiesi may not subcontract to any Third Party (including sub-distributors and contract sales organizations), without the prior written consent of Protalix, such consent not to be unreasonably delayed, withheld or conditioned, its rights or obligations to promote the Licensed Product (and the majority of the members of Chiesi’s sales force shall be employees of Chiesi or its Affiliate).
[***] Redacted pursuant to confidential treatment request.
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(a) Protalix shall notify the Steering Committee, at least every six (6) months during the Term, of any material updates with respect to any material Development activities, with respect to the Licensed Product for a New Indication (a “New Use”).
(b) [***].
(c) [***].
(a) During the Term of this Agreement, Chiesi and its Affiliates hereby covenant and agree not to, directly or indirectly, commence any legal proceeding, or to, directly or indirectly, provide support or assistance in respect of any legal proceeding commenced by a Third Party, that challenges the ownership of any Protalix Patent Right, including any Protalix System Patent Right, to the extent such Protalix Patent Right relates to the Compound or Licensed Product or the Development, Manufacture or Commercialization of the Compound or Licensed Product (a “Patent Ownership Challenge”).
(b) If Chiesi, its Affiliate or Sublicensee directly or indirectly commences (or provides any support or assistance in respect of) any Patent Ownership Challenge or any Other Patent Challenge, Protalix shall have the right to immediately terminate this Agreement by written notice effective upon receipt by Chiesi. The foregoing right of Protalix to terminate this Agreement shall not apply to any such challenge that arises out of or is in connection with any legal action commenced by Protalix against Chiesi, in which Protalix asserts any Protalix Patent Rights or other Patent Rights against Chiesi, whether arising out of or in connection with this Agreement or otherwise.
(c) For the purpose of this Section 2.6, the term “Other Patent Challenges” means any legal proceeding that challenges the validity or enforceability of any Protalix Patent Right, including any Protalix System Patent Right, to the extent such Protalix Patent Right relates to the Compound or Licensed Product or the Development, Manufacture or Commercialization of the Compound or Licensed Product (“Other Patent Challenge”).
(d) Without limiting the generality of the foregoing, Chiesi specifically agrees that filing a request for re-examination, knowingly copying patent claims so as to institute an interference, or filing an opposition with respect to any of the Protalix Patent Rights shall be deemed an Other Patent Challenge hereunder.
[***] Redacted pursuant to confidential treatment request.
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Section 3. DEVELOPMENT, REGULATORY APPROVALS AND MARKETING
3.2 Development Responsibilities.
[***] Redacted pursuant to confidential treatment request.
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[***] Redacted pursuant to confidential treatment request.
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(c) Responsibilities. The Steering Committee shall have the following roles and responsibilities:
(i) review and approve any material amendments to the Development Plan (subject to Section 3.3(d)). Any proposed material amendment to the Development Plan, including arguments to support such amendment, shall be made available to the Steering Committee with reasonable advance notice and at least five (5) Business Days ahead of the scheduled meeting;
(ii) provide reasonably detailed updates, data and other information regarding Protalix’s progress in Developing the Licensed Product in the Field;
(iii) provide updates in respect of any New Use in accordance with Section 2.5;
(iv) discuss the timing of transferring any regulatory filings in the Territory with respect to the Compound, Drug Substance, Drug Product or Licensed Product from Protalix to Chiesi in accordance with the terms of Section 3.6(c), and discuss and agree upon appropriate timelines for, and the responsibilities of each Party in respect of, preparing any regulatory filings for obtaining Regulatory Approval in any Country in the Territory. As part of such discussions, the Steering Committee shall discuss and agree on appropriate timelines and processes for the orderly transfer of all medical affairs functions from Protalix to Chiesi in accordance with Section 3.6(d)(iv);
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(v) act as a forum pursuant to which the Parties will review and discuss plans and strategies relating to (x) the Development of the Licensed Product in the Field, (y) regulatory matters with respect to the Licensed Product in the Field in the Territory, and (z) Commercialization of the Licensed Product in the Field in the respective territories of the Parties, to ensure aligned communication at medical congresses and other scientific events as well as scientific publication plans;
(vi) modify the division of regulatory responsibilities as between the Parties in accordance with Section 3.6(d)(v);
(vii) subject to the terms of Section 8.5, review and/or approval of each Party’s scientific publication plans;
(viii) oversee any Early Access Programs for the Licensed Product in the Field in the Territory;
(ix) review and agree upon the final version of the Initial Commercialization Plan, in accordance with Section 3.7(a), and review and provide comment upon any proposed revisions to, or any subsequent versions of, the Commercialization Plan (such comments to be considered in good faith by Chiesi);
(x) receiving from Chiesi reasonably detailed updates, data and other information regarding the status and details of any Price Approvals or Governmental Authority and Third Party reimbursement approvals in the Territory, in accordance with Section 3.7(c);
(xi) subject to Section 4.8(c), review and in good faith seek to resolve any disputes regarding any Notice of Non-Conformance issued in respect of a shipment of Drug Substance or Drug Product under the terms of this Agreement;
(xii) subject to Section 7.6(a), discuss any pertinent Third Party Patent Rights and decide upon whether a license to or acquisition of such Third Party Patent Rights or Technology is appropriate;
(xiii) discuss the possibility, from time to time, of sharing Licensed Product positioning and promotional materials for the Licensed Product in the Field, inside and outside the Territory;
(xiv) define the manner and timelines for Chiesi’s access to sites and records of the Ongoing Clinical Studies and [***] conducted by Protalix;
(xv) appoint the Referent Persons in accordance with Section 8.5;
(xvi) establish, if deemed necessary, the creation of a Joint Project Team (“JPT”) to oversee operations or activities. The composition of the JPT will be decided by the Steering Committee according to the type of activity and decision making in accordance with Section 3.3(d). The JPT shall be comprised of representatives from each Party with appropriate competence and level of decision-making authority. The JPT shall meet with a frequency to be agreed on by the Parties; and
[***] Redacted pursuant to confidential treatment request.
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(xvii) such other roles and responsibilities provided for in this Agreement or as may be assigned to the Steering Committee in writing by mutual agreement of the Parties.
(i) the Chiesi Chair shall have the final decision-making authority with respect to (A) Commercialization of the Licensed Product in the Field in the Territory, (B) regulatory plans and strategies relating to the Licensed Product in the Field in the Territory, (C) following Launch in a Country, Commercial Medical Affairs and Pharmacovigilance in such Country, and (D) following the transfer contemplated in Section 3.6(c), on a Country-by-Country basis, any and all regulatory matters concerning the Licensed Product, including in respect of any Regulatory Approvals, associated regulatory filings, or post-approval communications with or requirements of any Regulatory Authorities, subject to the obligation to consider the other Party’s comments in good faith;
(ii) the Protalix Chair shall have the final decision-making authority with respect to (A) the Development of the Licensed Product (and the Ongoing Clinical Studies but not the [***], Registry, Required Registry or [***], which shall be addressed as otherwise expressly provided herein), including any regulatory matters concerning the Licensed Product prior to the transfers contemplated in Section 3.6(c), any medical affairs and pharmacovigilance functions prior to the transfers contemplated in Section 3.6(d) (and, for the avoidance of doubt, any issues relating to the Licensed Product outside the Field or outside the Territory), subject to the obligation to consider the other Party’s comments in good faith, (B) the Protalix Patent Rights and Protalix Technology and Protalix’s rights in or to the Protalix Patent Rights and Protalix Technology, and (C) [***] or other issues relating to the Licensed Product outside the Territory or outside the Field; and
(iii) in the event of a disagreement in respect of a matter unrelated to the subject-matter of Sections 3.3(d)(i) or 3.3(d)(ii), such matters shall be subject to the escalation and dispute resolution procedures set out in Section 14.2.
For the avoidance of doubt, to the extent that Protalix, in its sole discretion, deems it necessary due to a request or demand of a Regulatory Authority (but only where such request is mandatory or where failure to comply with such request could result in a penalty or actions against Protalix being imposed by such Regulatory Authority or a violation of applicable Law) or identified and immediate risk to patient safety, Protalix shall have the sole authority and the exclusive right to decide any matter in respect of the Development of the Licensed Product in the Field (other than with respect to (i) approving regulatory plans and strategies, and (ii) preparing and submitting regulatory filings and obtaining Regulatory Approvals after the transfer contemplated in Section 3.6(c)) without the approval of or any decision by the Steering Committee; provided, however, that Protalix shall use its reasonable efforts to provide notice to, and consult with, members of the Steering Committee, prior to exercising such discretion.
[***] Redacted pursuant to confidential treatment request.
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(i) Chiesi (or one or more of its designated Affiliates) will own and be responsible for preparing, seeking, and submitting such regulatory filings as are necessary to obtain Regulatory Approval and then maintaining all Regulatory Approvals and any post-approval regulatory filings, for the Licensed Product in the Field in such Country in the Territory, including preparing all reports necessary as part of such Regulatory Approvals or post-approval regulatory filings. Protalix shall have the right and be responsible to prepare and promptly submit to Chiesi any non-clinical, clinical and Manufacturing portions (including CMC) of such regulatory filings and any related reports (subject to Chiesi’s approval rights with respect to such regulatory filing as a whole), at Chiesi’s sole cost and expense (unless such costs are Development Costs or other costs expressly addressed hereunder or by a separate agreement between the Parties, such as in relation to [***] or costs for Event Milestone 1a Studies). Protalix shall consider in good faith any proposed revision reasonably made by Chiesi thereto and Protalix shall otherwise provide such assistance as Chiesi reasonably requires, at Chiesi’s sole cost and expense (unless such costs are Development Costs or other costs expressly addressed hereunder or by a separate agreement between the Parties, such as in relation to [***] or costs for Event Milestone 1a Studies), to obtain Regulatory Approvals for the Licensed Product in the Field in the Territory.
(ii) Following the transfer contemplated in Section 3.6(c), but in any event, no later than the grant of Regulatory Approval, on a Country-by-Country basis, Chiesi shall (A) subject to Section 5.3(d), assume sole responsibility for seeking authorization in respect of, conducting, and otherwise interacting with Regulatory Authorities in respect of, any Post-Approval Studies, and (B) have the right to apply for, and secure, exclusivity rights that may be available under the Laws of such Countries in the Territory, including any Regulatory Exclusivity. Protalix shall reasonably cooperate with Chiesi, and take such reasonable actions to assist Chiesi, at Chiesi’s sole cost and expense, in obtaining such exclusivity rights in each Country, as Chiesi may reasonably request from time to time.
For the avoidance of doubt (A) at all relevant times during the Term, Chiesi shall have the final decision-making authority in respect of all regulatory plans and strategies for the Licensed Product in the Field in the Territory; provided that Chiesi shall reasonably consider any comments on such plans and strategies that Protalix may communicate (through the Steering Committee or otherwise); and (B) following a Regulatory Approval in a Country in the Territory, Chiesi shall be solely responsible for any such activities as are initiated after the date of such Regulatory Approval that would otherwise constitute Development activities had they been initiated prior to the grant of such Regulatory Approval.
[***] Redacted pursuant to confidential treatment request.
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(d) Transfer of Regulatory Responsibilities. Subject to the terms of the Development Plan:
(i) The Parties shall cooperate through the Steering Committee to ensure that any such assignments and transfers under Section 3.6(c), do not impede Protalix’s ability to conduct and complete the Ongoing Clinical Studies and [***]. After each such assignment and transfer is effective, Chiesi shall (and does hereby) grant Protalix a right to use and make reference to such regulatory filings so assigned and transferred (and any subsequent regulatory filings made or Regulatory Approvals in such Countries as are obtained by Chiesi in respect of the Licensed Product in the Field) as necessary for Protalix (x) to conduct and complete the Ongoing Clinical Studies and any [***], and (y) to conduct and complete any other clinical studies as necessary for Protalix to complete in order to file, and to file, for Regulatory Approval for (A) the Licensed Product outside the Territory, or (B) any New Use (or other drug product containing the Drug Substance outside of the Field) anywhere in the world.
(ii) After such transfer of ownership of such regulatory filings relating to the Drug Substance (or Drug Product) as incorporated into the Licensed Product (and for the avoidance of doubt, excluding any regulatory filings and Regulatory Approvals with respect to the Drug Substance (or Drug Product) as part of any New Use), or Licensed Product in the Field in the Territory, during the Term, all regulatory filings seeking Regulatory Approval in such Countries in the Territory and all subsequent post-approval regulatory filings that are filed with the applicable Regulatory Authorities and which pertain to the Drug Substance (or Drug Product) as incorporated into the Licensed Product (and for the avoidance of doubt, excluding any such regulatory filings with respect to the Drug Substance (or Drug Product) as part of any New Use), or Licensed Product in the Field, in each case, in the Territory, shall be made in the name of Chiesi or its Affiliates in accordance with Section 3.6(e), and any Post-Approval Studies shall be conducted in the name of, and shall be the sole responsibility of, Chiesi and its Affiliates (subject to Section 5.3(f)).
[***] Redacted pursuant to confidential treatment request.
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(iii) For the avoidance of doubt, Protalix shall remain responsible for the preparation of any non-clinical (including pre-clinical and CMC), clinical, and Manufacturing portions of regulatory filings submitted by Chiesi seeking Regulatory Approval with the EMA, and shall otherwise provide reasonable assistance to Chiesi in finalizing such regulatory filings for submission to the applicable Regulatory Authority (in each case subject to Chiesi’s approval rights with respect to the regulatory filing as a whole).
(iv) As part of the process of fixing a time for the regulatory transfer contemplated under Section 3.6(c), and subject to the terms of the Pharmacovigilance Agreement, on a Country-by-Country basis, the Steering Committee shall also set out a timeline for the orderly transfer of any pharmacovigilance (for post-Launch Commercialization) and medical affairs functions from Protalix to Chiesi (as well as the role of primary contact for KOL management and patient advocacy) (such functions, following the completion of such transfer from Protalix to Chiesi, to be referred to as “Commercial Medical Affairs and Pharmacovigilance”), with such medical affairs functions to be fully transferred within twelve (12) months of the Effective Date, but prior to the grant of Regulatory Approval in such Country, and with such pharmacovigilance functions to be fully transferred upon Launch; provided, that until such time as each of the Ongoing Clinical Trials and any [***] are completed, and the clinical study reports for each such clinical study are finalized, Protalix shall retain responsibility for patient safety monitoring, and shall remain the primary contact with each applicable KOL, in respect of such clinical studies.
(v) Notwithstanding anything to the contrary herein, but subject to the terms of the Pharmacovigilance Agreement, the Steering Committee may by mutual agreement modify the division of regulatory responsibilities as between the Parties, including by having Protalix retain certain regulatory responsibilities following the transfer contemplated by Section 3.6(c), or by having Chiesi assume certain regulatory responsibilities prior to the transfer contemplated by Section 3.6(c) (including, for the avoidance of doubt, where such division of responsibilities differs from the terms of the Development Plan); provided, however, that (i) in no circumstances may Chiesi assume responsibility for or control over any clinical aspects of the Development Plan, including the conduct of the Ongoing Clinical Studies (except in the case of Chiesi exercising its step-in rights as provided for in Section 3.2 or the conduct by Chiesi of any [***], Additional Studies, Registry, Required Registry or [***] as provided hereunder); and (ii) in any event, all regulatory responsibilities in respect of the Licensed Product in the Field in the Territory (including, for clarity, each of the transfers of regulatory responsibility contemplated in this Section 3.6), on a Country-by-Country basis, must be completely assumed by Chiesi within [***]; provided, that until such time as each of the Ongoing Clinical Trials and any [***] are completed, and the clinical study reports for each such clinical study are finalized, Protalix shall retain responsibility for patient safety monitoring, and shall remain the primary contact with each applicable KOL, in respect of such clinical studies.
[***] Redacted pursuant to confidential treatment request.
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[***] Redacted pursuant to confidential treatment request.
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(g) Communications with Regulatory Authorities.
(i) For so long as [***], Protalix, and after the assignment and transfer to Chiesi of such regulatory filings pursuant to Section 3.6(c), Chiesi, shall provide the other Party with notice of all meetings, conferences, and discussions (including advisory committee meetings or any other meeting of experts convened by a Regulatory Authority concerning any topic relevant to the Licensed Product) scheduled with a Regulatory Authority concerning any regulatory matters relating to the Licensed Product in the Field promptly after the scheduling of such meeting, conference, or discussion. The Party that does not, at the time of such meeting, own the regulatory filings described in Section 3.6(c) for the Licensed Product shall be entitled to have one or more representatives present at all such meetings to the extent permissible under applicable Law and reasonably practicable under the circumstances. Protalix and Chiesi shall use all reasonable efforts to agree in advance on the scheduling of such meetings, conferences and discussions and on the objectives to be accomplished at such meetings, conferences and discussions and the agenda for the meetings, conferences and discussions with the applicable Regulatory Authority, if any [***].
(ii) For so long as [***], Protalix, and after [***], Chiesi, shall provide the other Party with copies, which copies may be in draft form, of all material submissions to any Regulatory Authority relating to the Licensed Product in the Field. Such copies shall be provided sufficiently in advance of such planned submission to the applicable Regulatory Authority in order to allow such other Party to provide comments regarding such submission. The Party making the submission shall consider the other Party’s comments in good faith with respect to such submission [***].
(iii) Each Party shall provide to the other Party, as soon as reasonably practicable but in no event more than [***] after its receipt, copies of any material documents or other material correspondence received from a Regulatory Authority pertaining to the Licensed Product in the Field.
[***] Redacted pursuant to confidential treatment request.
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3.7 Commercialization and Pricing.
(a) An initial draft Commercialization plan for the Licensed Product in the Field in the Territory prepared by Chiesi is attached as Schedule 3.7 hereto, and the final version of such Commercialization plan shall be discussed and agreed upon between the Parties within [***] from the first Steering Committee Meeting (the “Initial Commercialization Plan”). Chiesi shall update such plan (any such updated plan, the “Commercialization Plan”) at least once per Calendar Year. Each such subsequent Commercialization Plan shall be submitted to the Steering Committee for review and discussion no later than thirty (30) days prior to the beginning of the immediately succeeding Calendar Year. Protalix may, through its representatives on the Steering Committee, propose to Chiesi revisions to any such subsequent Commercialization Plan, and any proposed material updates or amendments to the Initial Commercialization Plan and any subsequent Commercialization Plan, that Protalix reasonably believes are appropriate, and Chiesi shall consider any such proposed revisions in good faith, but such Initial Commercialization Plan or Commercialization Plan, or any material amendments or updates thereto, shall not require approval of the Steering Committee.
(b) Chiesi shall have the sole authority and exclusive right to Commercialize, and shall be responsible for paying all costs and expenses associated with the Commercialization of, the Licensed Product in the Field in the Territory, including marketing, promoting, advertising, distributing, disposing, offering for sale, selling, Labeling and Packaging, final product release testing, exporting and importing, and [***] and obtaining any necessary Price Approvals at its sole discretion. Chiesi hereby agrees to refrain from selling the Licensed Product in the Territory to any Person if Chiesi has knowledge or reason to believe that such Licensed Product is intended for transshipment or delivery by such Person outside the Territory.
(c) At meetings of the Steering Committee, Chiesi will provide Protalix with periodic updates regarding the status and details of Price Approvals and Governmental Authority and Third Party reimbursement approvals in each applicable Country in the Territory.
[***] Redacted pursuant to confidential treatment request.
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(i) The quality of the Licensed Product sold by Protalix outside the Territory under or in connection with the Product Marks must be of a sufficiently high quality to be generally comparable to the quality of the Licensed Product sold by Chiesi in the Territory under or in connection with the Product Marks. The quality of the Licensed Product sold by Chiesi in the Territory under or in connection with the Protalix Trademarks must be of a sufficiently high quality to be generally comparable to the quality of the Licensed Product sold by Protalix outside of the Territory under or in connection with the Protalix Trademarks.
(ii) Protalix shall comply with all applicable Laws pertaining to the proper use and designation of the Product Marks. Chiesi shall comply with all applicable Laws pertaining to the proper use and designation of the Protalix Trademarks.
(iii) Protalix agrees to use the Product Marks only in the form and manner and with appropriate legends as prescribed from time to time during the Term by Chiesi. Chiesi agrees to use the Protalix Trademarks only in the form and manner and with appropriate legends as prescribed from time to time during the Term by Protalix.
(iv) Protalix shall display the proper form of trademark notice associated with the Product Marks. Chiesi shall display the proper form of trademark notice associated with the Protalix Trademarks.
(v) Protalix shall not use any Product Xxxx as a corporate name, business name, or trade name. Chiesi shall not use any Protalix Trademark as a corporate name, business name, or trade name.
(vi) Protalix shall not use any Product Xxxx in a manner that would reasonably be expected to materially impair the validity, reputation, or distinctiveness of any Product Xxxx. Chiesi shall not use any Protalix Trademark in a manner that would reasonably be expected to materially impair the validity, reputation, or distinctiveness of any Protalix Trademark.
[***] Redacted pursuant to confidential treatment request.
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(vii) Protalix shall not use any Product Xxxx in a manner that would reasonably be expected to materially impair the reputation of Chiesi or any of its Affiliates. Chiesi shall not use any Protalix Trademark in a manner that would reasonably be expected to materially impair the reputation of Protalix or any of its Affiliates.
(i) Chiesi shall have the sole right, but not the obligation, to institute litigation or take other remedial measures in connection with Third Party infringement of Product Marks in the Territory. Any recoveries obtained by Chiesi resulting from such litigation or other appropriate action in the Territory in relation to the Product Marks, will be deemed Net Sales after having deducted any amount necessary to cover all costs and expenses incurred by Chiesi pursuant to the following sentence. All costs and expenses incurred by Chiesi in enforcing the Product Marks in the Territory shall be at Chiesi’s sole cost and expense. Protalix shall have the sole right, but not the obligation, to institute litigation or take other remedial measures in connection with Third Party infringement of Protalix Trademarks in the Territory. Upon request of Protalix, Chiesi agrees to timely join as party-plaintiff in any litigation in the Territory in relation to the Protalix Trademarks, and in any event to cooperate with Protalix in connection with any infringement action in the Territory in relation to the Protalix Trademarks, at Protalix’s cost and expense. All costs and expenses incurred by Protalix in enforcing the Protalix Trademarks in the Territory [***]. Protalix shall retain all recoveries received by Protalix as a result of its enforcement of the Protalix Trademarks in the Territory.
(ii) Protalix shall have the sole right, but not the obligation, to institute litigation or take other remedial measures in connection with Third Party infringement of Protalix Trademarks outside the Territory and the first right, but not the obligation, to institute litigation or take other remedial measures in connection with Third Party infringement of Product Marks outside the Territory. If Protalix declines to initiate litigation or take other remedial measures against a Third Party who is alleged to be infringing a Product Xxxx outside the Territory within ninety (90) days after becoming aware of the basis for such litigation or action, then Chiesi may, in its discretion, have the right to initiate litigation or take other appropriate action that it believes is reasonably required to protect its rights to the Product Marks outside the Territory. Upon request of Chiesi, Protalix agrees to timely join as party-plaintiff in any such litigation, and in any event to cooperate with Chiesi in connection with such infringement action at Chiesi’s cost and expense. Any recoveries obtained by Protalix resulting from such litigation or other appropriate action outside of the Territory in relation to the Product Marks or Protalix Trademarks shall be retained by Protalix. All costs and expenses incurred by Protalix in enforcing the Product Marks and Protalix Trademarks outside the Territory shall be at Protalix’s sole expense. All costs and expenses incurred by Chiesi in enforcing the Product Marks outside the Territory [***]. Chiesi shall retain all recoveries received by Chiesi as a result of its enforcement of the Product Marks outside the Territory.
[***] Redacted pursuant to confidential treatment request.
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3.11 [***]
Section 4. MANUFACTURE AND SUPPLY.
4.2 [***].
(a) Prior to [***]. Prior to [***], (i) Protalix shall be responsible for delivery of Drug Substance to [***] with respect to commercial supply of Licensed Product for sale in the Territory and shall use Commercially Reasonable Efforts to cause [***] to conduct, pursuant and subject to and in accordance with the terms and conditions of the [***], [***] activities for supply of Drug Product to Chiesi, and (ii) Chiesi shall be responsible for Labeling and Packaging with respect to commercial supply of Licensed Product for sale in the Territory and shall ensure, in all material respects, that Labeling and Packaging activities for commercial supply of Licensed Product for sale in the Territory comply with applicable Law, GMP and the Regulatory Approvals for the Licensed Product in the Territory, including the Product Specifications.
[***] Redacted pursuant to confidential treatment request.
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(b) [***]
[***] Redacted pursuant to confidential treatment request.
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4.6 Pricing, Invoicing and Supply Price Reconciliation.
(a) Supply Delivery Price; Invoices.
(i) Each delivery of Drug Product [***] under a Purchase Order hereunder shall be accompanied by an invoice. Protalix shall invoice such Drug Product [***] at the Price as at the date of such invoice. Chiesi shall issue payment against such invoices within [***] of the invoice date. Protalix shall include the following information, where applicable, on all invoices: the type, description, and quantity of the product delivered; the date of shipment; the prices; any applicable taxes, transportation charges or other charges provided for in the applicable Purchase Order; and the applicable Purchase Order number.
[***] Redacted pursuant to confidential treatment request.
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(e) [***]
(f) For the purposes of this Agreement, the “Applicable Rate” shall mean [***]:
Aggregate Annual Net Sales of Licensed Products (together with Direct Sublicensee Revenue B) |
Applicable Rates | |
Less than [***]
|
[***] | |
Equal to or greater than [***] and less than [***]
|
[***] | |
Equal to or greater than [***] and less than [***]
|
[***] | |
Equal to or greater than [***] and less than [***]
|
[***] | |
Equal to or greater than [***] | [***] |
[***] Redacted pursuant to confidential treatment request.
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(i) [***]; and,
(ii) [***].
Each Reconciliation Adjustment shall be settled against receipt of a proper credit note or debit note within [***] of the note date; provided that if any Reconciliation Amount is in the favor of Chiesi, such amounts shall be credited against the amount stated on the next issued invoice relating to the delivery of Drug Product [***] by Protalix to Chiesi under this Agreement.
[***] Redacted pursuant to confidential treatment request.
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4.8 Certificate of Analysis; Acceptance and Returns.
(a) Certificate of Analysis; Notice of Non-Conformance.
(i) Protalix shall supply to Chiesi the applicable batch number for the Drug Product [***] delivered, as well as such other information as the Parties may set forth in the Quality Agreement with respect to Manufacture (a “Manufacturing Certificate of Analysis”) for all Drug Product [***] shipped to Chiesi hereunder. Chiesi shall (within the time period specified in Section 4.8(b)) inspect, or cause to have inspected, each shipment of the Drug Product [***] for any material damage, defect or shortage and give Protalix written notice of any such material damaged, defective or short shipment (a “Notice of Non-Conformance”) within the time periods specified in Sections 4.8(a)(ii) and 4.8(b), as applicable.
(ii) Latent defects shall be communicated to Protalix, together with appropriate detail, within fifteen (15) Business Days of the date on which such latent defect was first discovered by Chiesi or was notified to Chiesi by the relevant Party discovering the defect.
[***] Redacted pursuant to confidential treatment request.
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[***] Redacted pursuant to confidential treatment request.
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[***] Redacted pursuant to confidential treatment request.
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(b) Sharing of Responsibility and Cost.
(i) For so long as subclause (x) of Section 4.6(h)(ii) applies in a given Country in the Territory, (A) Chiesi shall bear the [***] responsibility for maintaining the Drug Product included in the Safety Stock Amount for such Country through the inclusion of and payment for such Drug Product (as part of, and not in addition to) in applicable Purchase Orders placed in accordance with Section 4.5 and, for clarity, in the Yearly Reconciliation provided for under Section 4.6(h), and (B) Protalix shall bear the [***] responsibility for maintaining the Drug Substance included in the Safety Stock Amount for such Country. On and from the date that such subclause (x) of Section 4.6(h)(ii) no longer applies in a given Country in the Territory in accordance with such Section, the Parties shall share equally the responsibility [***] of building and maintaining the Safety Stock Amount for Drug Substance and Drug Product for such Country, in a manner to be mutually agreed upon by the Parties in good faith at the same time the Maximum Order Quantity is agreed upon in accordance with Section 4.6(i) (and, for clarity, such Safety Stock Amount shall not be included in the Drug Product [***] ordered for such Country for purposes of the Yearly Reconciliation). For clarity, following [***], Chiesi shall be solely responsible for the maintenance of any Safety Stock Amount of Drug Product [***]. Chiesi shall reimburse Protalix for its [***] share of the Safety Stock consisting of [***] within [***] of Protalix providing Chiesi an invoice therefor.
(ii) The Forecasts and Purchase Orders submitted by Chiesi pursuant to Section 4.5 shall make a distinction between the amounts of Drug Product and Drug Substance required by Chiesi for commercial needs in the Territory and the amounts of Drug Product and Drug Substance needed for Safety Stock. For the avoidance of doubt, Protalix shall hold and keep the Safety Stock Amount of Drug Substance and, at Chiesi’s option, Chiesi or [***] shall hold and keep the Safety Stock Amount (or a portion thereof) of Drug Product. Protalix shall, upon reasonable request and during regular business hours with as minimal disruption to Protalix’s operations as reasonably practicable, allow Chiesi to audit the quantity of Safety Stock in Protalix’s possession.
4.13 [***]
(a) [***]
(b) [***]
(c) Business Continuity Plan. Within [***], Protalix shall provide Chiesi with a copy of a business continuity risk assessment and plan for Protalix in relation to the Manufacture and supply of the Drug Product by Protalix hereunder. Such plan (i) shall include an assessment regarding a potential alternative to the current quality control laboratory, and (ii) is intended to be reviewed by Protalix on a yearly basis. Upon Chiesi’s request, Protalix shall provide Chiesi information regarding the results of any such review.
[***] Redacted pursuant to confidential treatment request.
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(a) “Failure to Supply” shall occur in the event that Protalix does not supply according to the terms of this Agreement (to the Person responsible for Fill/Finish) for reasons within Protalix’s reasonable control (and, for clarity, not for reasons outside Protalix’s reasonable control, i.e., a Force Majeure Event) at least [***] of the quantities of Drug Substance specified by Chiesi on Purchase Orders covering [***] (a “Supply Failure”), and such Supply Failure is not cured in the following [***] (whether by using Safety Stock or otherwise). For clarity, notwithstanding anything to the contrary herein, a failure to supply will not be treated as a Supply Failure under this Section 4.14(a) if such failure to supply was due to the failure to conduct Fill/Finish activities or Labeling and Packaging. For the sake of this Section 4.14(a), “cure” means supplying at least [***] of the quantities of Drug Substance specified by Chiesi on the applicable Purchase Orders that are the subject of the Supply Failure.
(c) Allocation of Costs. Protalix shall be responsible for [***].
(e) [***].
(f) [***]
Section 5. FINANCIAL PROVISIONS
[***] Redacted pursuant to confidential treatment request.
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(a) Subject to the terms and conditions of this Agreement, Chiesi shall pay to Protalix the amount set forth in the table below opposite the corresponding event milestone (each an “Event Milestone”) within thirty (30) days after the occurrence of such Event Milestone:
Event Milestone | Event Milestone Payment | |
[***] (“Event Milestone 1a”)
|
[***] | |
[***] (“Event Milestone 1b”)
|
[***] | |
Annual Net Sales of the Licensed Product in the Territory (together with the Direct Sublicensee Revenue B) equal to or in excess of [***] (“Event Milestone 2”)
|
[***] | |
Annual Net Sales of the Licensed Product in the Territory (together with the Direct Sublicensee Revenue B) equal to or in excess of [***] (“Event Milestone 3”)
|
[***] | |
Annual Net Sales of the Licensed Product in the Territory (together with the Direct Sublicensee Revenue B) equal to or in excess of [***] (“Event Milestone 4”)
|
[***] | |
Annual Net Sales of the Licensed Product in the Territory (together with the Direct Sublicensee Revenue B) equal to or in excess of [***] (“Event Milestone 5”)
|
[***] | |
Annual Net Sales of the Licensed Product in the Territory (together with the Direct Sublicensee Revenue B) equal to or in excess of [***] (“Event Milestone 6”)
|
[***] | |
Annual Net Sales of the Licensed Product in the Territory (together with the Direct Sublicensee Revenue B) equal to or in excess of [***] (“Event Milestone 7”)
|
[***] | |
Annual Net Sales of the Licensed Product in the Territory (together with the Direct Sublicensee Revenue B) equal to or in excess of [***] (“Event Milestone 8”)
|
[***] | |
Annual Net Sales of the Licensed Product in the Territory (together with the Direct Sublicensee Revenue B) equal to or in excess of [***] (“Event Milestone 9”)
|
[***] |
[***] Redacted pursuant to confidential treatment request.
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Annual Net Sales of the Licensed Product in the Territory (together with the Direct Sublicensee Revenue B) equal to or in excess of (“Event Milestone 10”) | [***] |
(b) [***].
(c) For the avoidance of doubt: (i) subject to Section 5.2(d) below, each Event Milestone Payment shall be payable only on the first occurrence of the corresponding Event Milestone; and (ii) none of the Event Milestone Payments shall be payable more than once.
(d) In respect of Event Milestones 2 through 10, should more than one Event Milestone occur in any Commercial Year, then only the highest of such Event Milestone Payments shall be due and payable in such Commercial Year (however, any Deferred Milestones may also be due and payable in such Commercial Year, subject to the below). For example, if Protalix achieves Event Milestone 2, Event Milestone 3, Event Milestone 4, and Event Milestone 5 in the first Commercial Year of this Agreement, only the Event Milestone Payment for Event Milestone 5 shall be due and the Event Milestone Payments for Event Milestone 2, Event Milestone 3 and Event Milestone 4 shall be deferred as set forth below and not paid in that Commercial Year (each, a “Deferred Milestone”). Such Deferred Milestones shall become due and payable in any subsequent Commercial Year in which the corresponding Event Milestone for each such Deferred Milestone is again achieved (irrespective of whether a higher Event Milestone is also achieved in such Commercial Year); provided, that the aggregate Net Sales (together with Direct Sublicensee Revenue B) for such subsequent Commercial Year have not decreased, as compared to the highest amount of Net Sales (together with Direct Sublicensee Revenue B) achieved in any previous Commercial Year. If the aggregate Net Sales (together with Direct Sublicensee Revenue B) for such subsequent Commercial Year has decreased, than only the highest Event Milestone achieved in such year will be payable (i.e., any unpaid Deferred Milestones again shall be deferred to the next Commercial Year). Following on from the above example, if in the subsequent Commercial Year Protalix achieves Event Milestone 2 and Event Milestone 3 only (meaning that there has been a decrease), then in such Commercial Year, the Deferred Milestone for Event Milestone 3 shall be due and payable (being the highest unpaid Event Milestone achieved in such Commercial Year), but the Deferred Milestone for Event Milestone 4 shall remain unpaid (as the corresponding Event Milestone was not achieved in that Commercial Year), and the Deferred Milestone for Event Milestone 2 shall also remain unpaid (as there was a decrease in Net Sales (together with Direct Sublicensee Revenue B)). If instead, the Net Sales (together with Direct Sublicensee Revenue B) increased (for example, Event Milestone 6 had been achieved), than each of the Deferred Milestones for Event Milestone 2, Event Milestone 3 and Event Milestone 4 will be due and payable in such Commercial Year (in addition to the Event Milestone Payment for Event Milestone 6). Following the above example, and assuming that in that second Commercial Year there had been a decrease in aggregate Net Sales (together with Direct Sublicensee Revenue B), but that in the third Commercial Year, Protalix achieves each of Event Milestone 2, Event Milestone 3, Event Milestone 4, Event Milestone 5, and Event Milestone 6, then in such year, the Event Milestone Payment for Event Milestone 6 shall be due (as that is the highest of the Event Milestones achieved), as well as any unpaid Deferred Milestones (in the above example, the remaining Deferred Milestones would be Event Milestone 2 and Event Milestone 4).
[***] Redacted pursuant to confidential treatment request.
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(e) Protalix acknowledges and agrees that the right to receive Event Milestone Payments is not a security, shall not be represented by a certificate or other instrument and shall not represent a security or ownership interest in Chiesi, its Affiliates or any of their respective assets.
(f) NOTWITHSTANDING THIS SECTION 5.2, PROTALIX MAKES NO REPRESENTATION, WARRANTY OR COVENANT, EITHER EXPRESS OR IMPLIED, THAT IT WILL BE ABLE TO SUCCESSFULLY DEVELOP AND CHIESI MAKES NO REPRESENTATION, WARRANTY OR COVENANT, EITHER EXPRESS OR IMPLIED, THAT IT WILL BE ABLE TO SUCCESSFULLY COMMERCIALIZE THE LICENSED PRODUCT.
[***] Redacted pursuant to confidential treatment request.
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(d) [***]. In the event that either Party is obligated to undertake one or more [***] under the terms of this Agreement, subject to this Section 5.3(d), [***] for such [***] (“[***]”), within [***] of a receipt of an invoice therefor. A separately established cap (the “Required Studies Cap”) shall apply to any such [***], on the same terms and amounts set forth in Sections 5.3(b) and 5.3(c) (applying mutatis mutandis). For the avoidance of doubt, such Required Studies Cap for the [***] shall be calculated and accounted for separate from, and the [***] shall not in any event be included as a part of, the Development Costs Cap or Annual Cap under Sections 5.3(b) and 5.3(c).
(e) [***]. In the event that one or more Additional Studies are required by a Regulatory Authority in [***] for the purposes of obtaining (including, solely with respect to approvals granted upon specific conditions requiring the conduct of specified additional required studies to maintain such granted Regulatory Approval, maintaining) Regulatory Approval for the Licensed Product from a Regulatory Authority in [***], then, prior to proceeding with any such [***], both Parties must agree in writing (such agreement not to be unreasonably withheld, conditioned or delayed) whether to conduct such [***] and to any applicable terms thereto, including as to who will conduct such [***], the sharing or bearing of any costs and expenses associated with the conduct and completion of such [***] and the respective obligations of each Party in respect of the conduct of such [***]. With respect to any Country where a [***] is required by a Regulatory Authority, at the time the Parties agree on the conduct of, and cost-sharing (if any) between the Parties relating to, such [***] in accordance with the foregoing, the Parties shall also agree in writing in good faith on the appropriate financial provisions as between Chiesi and Protalix to apply to sublicensing in such Countries (including with respect to whether and to what extent, for such Country, the Other Sublicensee Revenue Payment (or some other method of addressing Other Sublicensee Revenue in such Country) should apply thereto, and how the Event Milestones and Applicable Rate provisions should apply thereto, with the understanding that if Protalix does not agree to share or bear at least [***] of the costs and expenses associated with the conduct and completion of the [***] for any such Country, such agreement [***].
[***] Redacted pursuant to confidential treatment request.
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Section 6. ACCOUNTING AND PROCEDURES FOR PAYMENT
6.1 Periodic Reporting and Reconciliation Payments.
[***] Redacted pursuant to confidential treatment request.
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6.5 Interest for Late Payments. If either Party fails to make any payment due under this Agreement within [***] of the date upon which such payment is due, then interest shall accrue on such payment on a daily basis from the date such payment was originally due at a rate equal to weekly LIBOR (as published in The Wall Street Journal, New York edition and as officially confirmed by an officer of the respective Party) plus [***], or at the maximum rate permitted by applicable Law, whichever is the lower, and such interest shall be paid when such payment is made.
[***] Redacted pursuant to confidential treatment request.
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[***] Redacted pursuant to confidential treatment request.
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Section 7. PATENTS AND INFRINGEMENT
(a) file Patent Applications on any invention included in the Protalix Patent Rights;
(b) take all reasonable steps to prosecute all pending and new Patent Applications included within the Protalix Patent Rights;
(c) respond to oppositions, interferences, nullity actions, re-examinations, revocation actions and similar proceedings filed by Third Parties against the grant of Patents for such Patent Applications; and
(d) maintain in force any patents in the Territory included within the Protalix Patent Rights by duly filing all necessary papers and paying any fees required by the relevant patent Laws of the particular Country in which the patent was granted.
[***]
[***] Redacted pursuant to confidential treatment request.
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(a) Protalix will keep Chiesi informed of the status of the Protalix Patent Rights to the extent the Protalix Patent Rights [***].
(b) Protalix will, upon Chiesi’s request, provide Chiesi with copies of all substantive documentation submitted to, or received from, the patent offices in the Territory in connection therewith. With respect to any Protalix Patent Rights that are not Protalix System Patent Rights, Protalix shall consider in good faith all comments provided by Chiesi with respect to a Protalix Patent Right in the Territory to the extent relating to the Compound or Licensed Product in the Field in the Territory or the Commercialization of the Licensed Product in the Field in the Territory. Protalix shall have final-decision making authority with respect to filings and prosecution of Protalix Patent Rights.
[***] Redacted pursuant to confidential treatment request.
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7.6 Third Party Royalty Obligations.
(a) If either Party reasonably determines in good faith that in order to avoid infringement of any Patent Right not licensed hereunder, it is reasonably necessary to obtain a license or acquire the relevant Patent Right or Technology from a Third Party in order to make, use, sell, offer for sale, supply, cause to be supplied, or import the Licensed Product in a Country in the Territory and to pay a royalty or other consideration under such license or acquisition (including in connection with the settlement of a patent infringement claim), then the Steering Committee shall discuss the pertinent Third Party Patent Right and/or Technology and such Party’s determination. If the Steering Committee decides (by mutual agreement of the Steering Committee members) that Chiesi should enter into such license or acquisition, Chiesi shall use Commercially Reasonable Efforts to negotiate and enter into a license or acquisition for such Third Party Patent Right and/or Technology. The Steering Committee (by mutual agreement of the Steering Committee members) shall determine each Party’s respective share of any payments to the relevant Third Party, other than as provided in Section 13.2.
(b) Other than as provided in Section 13.2, if Chiesi is subject to a final court or other binding order or ruling requiring any payments, including the payment of a royalty to a Third Party Patent holder in respect of Commercialization of the Licensed Product in a Country in the Territory, then the amount of such payments made by Chiesi to the Third Party shall be in addition to, and separate from, any payments due to Protalix under this Agreement; provided that the Steering Committee (by mutual agreement of the Steering Committee members) shall determine each Party’s respective share of any such payments to the relevant Third Party.
(a) Infringement of Protalix Patent Rights in the Field.
(i) Chiesi shall have the first right, but not the obligation, to institute litigation or take other remedial measures in connection with Third Party infringement of the Protalix Patent Rights occurring in the Field within the Territory [***], where such Third Party infringement would reasonably be expected to impair or has impaired the Commercialization of the Licensed Product in the Field in the Territory in any material respect. In order to establish standing, Protalix, upon request of Chiesi, agrees to timely commence or to join in any such litigation, at Chiesi’s cost and expense, and in any event to reasonably cooperate with Chiesi at Chiesi’s cost and expense. [***]
[***] Redacted pursuant to confidential treatment request.
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(ii) Protalix shall have the sole right, but not the obligation, to institute litigation or take other remedial measures in connection with Third Party infringement of any Protalix Patent Rights occurring outside of the Territory and with respect to Third Party infringement of any Protalix Patent Rights directed solely to any Outside of the Scope Product or occurring outside the Field (within or outside of the Territory) [***].
7.8 Other Actions by a Third Party.
(a) Each Party shall promptly notify the other in the event of any (i) claims by a Third Party of alleged patent infringement by Chiesi or Protalix or any of their respective Affiliates with respect to the research, Development, Manufacture, use, sale, offer for sale or importation of a Compound (other than as used in New Use) or the Licensed Product or (ii) legal or administrative action by any Third Party involving a Protalix Patent Right [***] of which it becomes aware, including any nullity, revocation, reexamination or compulsory license proceeding. Unless subject to the indemnity provided by Protalix under Section 13.2 (in which case Protalix shall have sole control of such action and the defense thereof) or by Chiesi under Section 13.1 (in which case Chiesi shall have sole control of such action and the defense thereof), Chiesi shall have the first right, but no obligation, to defend against any such action involving such Protalix Patent Right in the Territory when the alleged patent infringement would reasonably be expected to impair the Commercialization of the Licensed Product in the Field in the Territory in any material respect [***]. Protalix, upon request of Chiesi, agrees to join in any such action [***] and in any event to reasonably cooperate with Chiesi [***]. If Chiesi declines to defend Protalix against any such action involving a Protalix Patent Right, then Protalix shall have the right to defend such action [***]. Chiesi, upon request of Protalix, shall reasonably cooperate with Protalix in any such action [***]. The Party defending against such action in accordance with this Section 7.8 shall assume direction and control of the defense, litigation, settlement, appeal or other disposition of such Claim (including the right to settle the Claim solely for monetary consideration for which such Party will be responsible) with counsel selected by such Party and reasonably acceptable to the other Party. The other Party shall have the right to join in (including the right to conduct discovery, interview and examine witnesses and participate in all settlement conferences), but not control, at its own expense, the defense of any Claim that such Party is defending as provided in this Section 7.8.
(b) Neither Party will enter into any settlement of any suit involving Licensed Products that materially affects the other Party’s rights or obligations with respect to the Licensed Product without the other Party’s prior written consent (which consent shall not be unreasonably withheld, delayed or conditioned). Without limiting the foregoing, neither Party shall, without the written consent of the other Party (which consent shall not be unreasonably withheld, delayed or conditioned), effect any settlement of any pending or threatened litigation in which the other Party has any potential liability, unless such settlement involves solely monetary damages and includes an unconditional release of such other Party from all liability on Claims that are the subject matter of such litigation.
[***] Redacted pursuant to confidential treatment request.
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Section 8. CONFIDENTIALITY; PUBLICATION
[***] Redacted pursuant to confidential treatment request.
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[***] Redacted pursuant to confidential treatment request.
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Section 9. REPRESENTATIONS, WARRANTIES AND COVENANTS
(a) It is duly organized, validly existing and in good standing under the Laws of the jurisdiction of its incorporation or formation, as applicable. It has the requisite corporate power and authority to conduct its business as presently being conducted and as proposed to be conducted by it.
(b) It has the requisite corporate power and authority to enter into this Agreement and to perform its obligations hereunder. All corporate actions on its part, necessary for (i) the authorization, execution, delivery and performance by it of this Agreement, and (ii) the consummation of the transactions contemplated hereby, have been duly taken.
[***] Redacted pursuant to confidential treatment request.
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(c) Assuming the due authorization, execution and delivery by the other Party, this Agreement constitutes a legally valid and binding obligation of such Party, enforceable against it in accordance with its terms (except in all cases as such enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium, or similar Laws affecting the enforcement of creditors’ rights generally and except that the availability of the equitable remedy of specific performance or injunctive relief is subject to the discretion of the court or other tribunal before which any proceeding may be brought).
(d) There is no contractual restriction or obligation binding on such Party which would be materially contravened by execution and delivery of this Agreement or by the performance of its terms. Apart from expiration or termination of any applicable waiting periods (including any extensions thereof) required by any applicable Law or governmental entity for antitrust purposes in the Territory, there are no governmental filings or consents necessary for the consummation of this Agreement and the transactions contemplated hereby.
(e) Such Party is not debarred, and such Party in relation to the Licensed Product is not using, has not used, and will not use in any capacity the services of any person debarred, in each case under Subsection 306(a), (b) of the Generic Drug Enforcement Act of 1992, or any non-U.S. equivalent Law to the foregoing.
(f) To such Party’s knowledge, no representation or warranty made by it in this Agreement, nor any statement contained in any schedule hereto furnished by it, contains any untrue statement of a material fact or omits any material fact necessary to make the statements contained herein or therein not misleading.
(g) There is no litigation, proceeding or investigation pending or, to such Party’s knowledge, threatened against such Party in any court or before any agency or regulatory body which would reasonably be expected to materially adversely affect such Party’s ability or right to carry out the transactions contemplated by this Agreement.
(h) During the Term, each Party shall promptly notify the other Party in writing upon learning of any actual or threatened investigation, inquiry, action or proceeding before the EMA or any other Regulatory Authority in the Territory with respect to the Compound, Drug Substance, Drug Product or Licensed Product.
(i) Each Party shall (i) comply in all material respects with applicable anti-bribery Laws and the Chiesi Anti-Bribery Policy, attached hereto as Exhibit D, and (ii) adopt, implement and keep for the Term, reasonably adequate measures aimed at preventing the commission, even attempted, of conduct in violation in any material respect of anti-bribery Laws by its Affiliates, directors, representatives, employees, and/or consultants involved in the performance of this Agreement.
(j) Each Party and its Affiliates, directors, representatives, employees, and/or consultants involved in the performance of this Agreement, in performing their obligations under this Agreement shall not, directly or indirectly:
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(i) offer, transfer, promise or pay money, commissions, compensation or any other benefit (including gifts, entertainment, or any other similar benefit, even low value or non-material benefits, unless they can be considered as low value courtesy benefits) in favor of public or private parties, in violation of applicable anti-bribery Laws, the Chiesi Anti-Bribery Policy and/or with the intention of or as a condition to obtaining illegal benefits in favor of Chiesi or Protalix;
(ii) direct a Third Party to carry out the activities set out in subsection (i) above;
(iii) give, transfer or promise money, commissions, compensation and rewards in kind (including gifts, entertainment or any other similar benefit, even low value or non-material benefits, unless they can be considered as low value courtesy benefits) to the other Party’s directors, legal representatives, employees or whoever acts on behalf of such other Party, in violation of any applicable anti-bribery Law and beyond the limits set forth within the Chiesi Anti-Bribery Policy.
(k) Unless to the extent this provision would be a violation of any applicable Laws, Protalix shall promptly notify Chiesi at the following Chiesi e-mail address: xxxxxxxxxxxxxxx@xxxxxx.xxx, and Chiesi shall promptly notify Protalix at the following Protalix e-mail address: xxxxx.xxxxx@xxxxxxxx.xxx, if such Party becomes aware of:
(i) any request, promise, offer, or donation of money, commission, compensation or rewards in kind (including gifts, entertainments, or any other similar benefit, even low value or non-material benefits) made to public officers, private parties or the other Party’s directors, legal representatives or employees (or whoever acts on behalf of such other Party), in relation to the activities prohibited under Section 9.1(j);
(ii) any gift, entertainment or any other similar benefit, even non-material benefits, carried out by either Party in breach of the provisions of Section 9.1(j); or
(iii) any investigation, administrative suit, law suit or other procedure involving such Party in relation to corruption, bribery or any other similar harmful act to the public treasury.
(l) Each Party shall conduct, and shall use reasonable efforts to cause its Affiliates to conduct, all its activities contemplated under this Agreement in accordance with all applicable Laws of the Country in which such activities are conducted.
(a) Exhibit A contains a complete and correct list as of the Effective Date of all Patents and Patent Applications owned by Protalix covering the Compound, any Licensed Product and the System.
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(b) Protalix is the sole and exclusive owner of, or has exclusive rights to, all of the Protalix Patent Rights in existence on the Effective Date that relate to the Compound and/or the Licensed Product in the Field, and the Protalix Patent Rights set forth on Exhibit A are in full force and effect and free and clear of all liens and other encumbrances, security interests or options (other than pursuant to any agreements, secured debt or other financing referenced in Protalix’s or its Affiliates’ publically available filings).
(c) Protalix has the right to grant the licenses and rights in the Protalix Technology it purports to grant to Chiesi hereunder. For the avoidance of doubt, the foregoing representation and warranty shall not be deemed a representation or warranty with respect to non-infringement, which representation and warranty is solely addressed in Section 9.2(k).
(d) The Protalix Patent Rights and Protalix Technology include all of the Patent and other intellectual property rights owned or Controlled by Protalix or its Affiliates that are necessary for the Commercialization of the Licensed Product. The Protalix Patent Rights have been prosecuted and maintained in accordance with all applicable Laws in all material respects.
(e) No government funding, facilities or resources of a university, college, other educational institution, research center or Regulatory Authority was used in the creation or development of any Protalix Patent Rights and Protalix Technology, other than grants received from the Office of Chief Scientist of the Israeli Ministry of Industry, Trade and Labor.
(f) Any Third Party License relating to the rights licensed to Chiesi under Section 2.1 (and, as a consequence, may also relate to other provisions of this Agreement) is a legal and valid obligation binding upon Protalix and, to Protalix’s knowledge, the relevant Third Party licensor (in each case, subject to the effect of any applicable bankruptcy, reorganization, insolvency, moratorium or similar laws affecting creditors’ rights generally and subject, as to enforceability, to the effect of general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at law)), and authorizes, as necessary, Protalix to grant the sublicense(s) granted to Chiesi under this Agreement. As of the Effective Date, Protalix is in compliance in all material respects with any such Third Party License and Protalix covenants that during the Term it shall not modify or amend any Third Party License in a manner that would materially adversely affect Chiesi’s access or rights hereunder without the prior written consent of Chiesi. Protalix has received no notices, whether written or oral, from any Third Party licensor alleging any past or present breach by Protalix of the terms of any such Third Party License. Protalix has issued no notices, whether written or oral, to any Third Party licensor alleging any past or present breach by any Third Party licensor of the terms of the relevant Third Party License. Protalix has provided Chiesi with true, correct and complete copy of any Third Party License, including any amendments thereto.
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(g) Protalix shall not take any action that would materially adversely affect the rights granted to Chiesi hereunder with respect to any Third Party License, including selling, assigning or transferring the rights of Protalix under any Third Party License with respect to the Protalix Patent Rights and Protalix Technology, in each case, as relate to the Compound and/or the Licensed Product in the Field in the Territory, without Chiesi’s prior written consent. Protalix shall: (i) comply in all material respects with and perform all of its material duties and obligations under any Third Party License relating to the Protalix Patent Rights and Protalix Technology, in each case, as relate to the Compound and/or the Licensed Product in the Field in the Territory; (ii) not intentionally take or fail to take any action within Protalix’s reasonable control under any Third Party License that would materially adversely affect Chiesi’s rights under this Agreement; (iii) use its Commercially Reasonable Efforts to enforce the provisions of any Third Party License against the relevant Third Party licensor; and (iv) not modify, amend or terminate any Third Party License with respect to the Protalix Patent Rights or Protalix Technology, in each case, as relate to the Compound and/or the Licensed Product in the Field in the Territory, in a manner that would materially adversely affect Chiesi’s rights under this Agreement, without the prior written consent of Chiesi.
(h) Subject to Section 8, Protalix shall promptly notify Chiesi (other than to the extent Protalix, acting reasonably, determines that such notice could waive attorney-client privilege or any other legal privilege held by Protalix, or would otherwise breach a confidentiality provision or obligation) in writing of (i) any actual or threatened in writing default (including failure to pay royalties when due, if applicable), breach, suspension of compliance or performance, or termination (in whole or in part) under any Third Party License that relates to the Protalix Patent Rights or Protalix Technology, in each case, as relates to the Compound and/or the Licensed Product in the Field in the Territory, and which would materially adversely affect Chiesi’s rights under this Agreement; and (ii) the actual or threatened in writing commencement of any dispute, claim, suit, litigation or arbitration proceeding related to the any Third Party License that relates to the Protalix Patent Rights or Protalix Technology, in each case, as relates to the Compound and/or the Licensed Product in the Field in the Territory, and which would materially adversely affect Chiesi’s rights under this Agreement. Each such notification shall contain a summary of the event described therein. At the request of Chiesi, and subject to Section 8, Protalix shall (other than to the extent Protalix, acting reasonably, determines that to do so could waive attorney-client privilege or any other legal privilege held by Protalix, or would otherwise breach a confidentiality provision or obligation) (x) promptly provide to Chiesi full particulars, of which it is aware, in writing of the applicable matter; and (y) keep Chiesi reasonably informed as to the status and proposed resolution of each such matter.
(i) In the event that Protalix receives notice of any default (including failure to pay royalties or other amounts when due) or breach under any Third Party License that relates to the Protalix Patent Rights or Protalix Technology, in each case, as relates to the Compound and/or the Licensed Product in the Field in the Territory and which would materially adversely affect Chiesi’s rights under this Agreement, and (i) has not cured such breach or default within ten (10) Business Days of receiving such notice, (ii) has not procured the entry by Chiesi into a Standby License as described in Section 2.2(d), and (iii) the amount of, and liability for, such breach or default is not disputed by Protalix (acting in good faith) or has been resolved in Chiesi’s favor under Section 14.3, then Chiesi shall be entitled, but not obligated, to undertake payment or performance of the applicable underlying obligation on behalf of Protalix as necessary to cure such default or breach and to offset, against amounts payable to Protalix under this Agreement, any reasonable out-of-pocket costs and expenses incurred by Chiesi in the course thereof. In the event and to the extent that Protalix disputes the existence of such breach or default (acting in good faith), either Party may by written notice escalate the matter for discussions between the Chief Executive Officers of each Party to negotiate an agreed approach to the alleged breach or default and, to the extent the Parties cannot reach such agreement within thirty (30) days of the receipt of such notice, the Parties shall refer the matter for expert determination in accordance with Section 14.3.
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(j) There is no material active, pending or, to Protalix’s knowledge, threatened litigation or re-examination, pre- or post-grant or inter partes review, interference, derivation, opposition, claim of invalidity or other claim or proceeding (including in the form of any offer to obtain a license) alleging the invalidity, misuse, unregisterability, unenforceability or non-infringement of any Protalix Patent Rights, or challenging Protalix’s ownership of, or Protalix’s right to practice or license, any Protalix Patent Rights, or alleging any adverse right, title or interest with respect thereto (in each case, solely as relates to the Compound and/or the Licensed Product in the Field in the Territory).
(k) To the knowledge of Protalix after a reasonable internal inquiry of its executive officers and legal personnel, the practice of the Protalix Patent Rights and Protalix Technology in relation to the Compound and/or the Licensed Product in the Field in the Territory, and the Manufacture, use of the Compound, Drug Substance and/or Drug Product or Commercialization of Licensed Product (as now formulated) as contemplated under this Agreement, does not and will not infringe any issued Patent of any Third Party that exists on the Effective Date or, if and when issued, any Valid Claim within any Third Party Patent Application published before the Effective Date.
(l) Protalix and its Affiliates have complied in all material respects with all applicable Laws, with respect to the Development, Manufacture, use and handling of Compound, Drug Substance, Drug Product and Licensed Product.
(m) Protalix has not received any Form 483 observations, warning letters or other communications from a Regulatory Authority which would reasonably be expected to adversely impact the Development, Manufacture, use, handling of Compound, Drug Substance and/or Drug Product or the Commercialization of Licensed Product in any material respect.
(n) Drug Product (and Compound and Drug Substance) supplied by Protalix to Chiesi hereunder, prior to delivery by Protalix under Section 4.7: (i) will be Manufactured and stored in material compliance with the Product Specifications, GMP and all other provisions of this Agreement, the Quality Agreement and applicable Laws, including applicable environmental Laws, in force at the time of Manufacture, (ii) will not contain any material that would cause the Compound, Drug Substance and/or Drug Product to be adulterated or misbranded within the meaning of any applicable Laws and (iii) shall be free from defects in material and workmanship in all material respects.
(o) To Protalix’s knowledge, there are no material investigations, inquiries, actions or other proceedings pending before FDA, EMA or any other Regulatory Authority with respect to the Compound, Drug Substance, Drug Product or Licensed Product.
(p) Protalix has not withheld any data or information known to Protalix related to the Compound, Drug Substance, Drug Product or Licensed Product, including, but not limited to, preclinical and clinical data, regulatory filings and regulatory communications, in each case, that would reasonably be expected to be material to Chiesi’s decision to enter into this Agreement.
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(q) The information contained in the excel file provided by Protalix to Chiesi via e-mail on October 10, 2017 relating to the costs sustained by Protalix through June 30, 2017 for the Development of the Compound, Drug Substance, Drug Product and Licensed Product is accurate in all material respects.
(r) During the Term, Protalix shall not grant any rights in violation of the rights and licenses granted herein, and Protalix shall not assign the Protalix Patent Rights and/or material Protalix Technology in the Territory except to a permitted assignee of this Agreement pursuant to Section 15.6.
(s) Protalix shall perform its obligations under this Agreement in compliance in all material respects with applicable provisions of the International Federal of Pharmaceutical Manufacturers & Associations Code of Practice and applicable provisions of the Chiesi Code of Ethics and Conduct, attached hereto as Exhibit E.
(t) Protalix has obtained the assignment from the inventors of all inventorship rights in the Protalix Patent Rights owned by Protalix.
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This Agreement shall be effective as of the Effective Date and shall remain in effect until the later of (i) the expiration of the last enforceable Protalix Patent Right, or (ii) the 15th anniversary of Launch on a Country-by-Country basis, unless earlier terminated pursuant to Section 12 (the “Term”); [***].
12.1 Termination Rights. This Agreement may be terminated as follows:
[***] Redacted pursuant to confidential treatment request.
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(f) [***]. Without limiting its rights under Section 12.1(b):
(i) Protalix may terminate this Agreement (i) in its entirety, upon at least [***] written notice to Chiesi if within [***] of receipt of Regulatory Approval (and Price Approval and Governmental Authority or Third Party reimbursement approval where applicable and required) of the Licensed Product in the [***], Chiesi has not Launched for reasons within its reasonable control (and, for clarity, not for reasons outside Chiesi’s reasonable control, i.e., a Force Majeure Event) the Licensed Product in at least one Country [***], or (ii) on a Country-by-Country basis, upon at least thirty (30) days’ written notice to Chiesi, if for a period of [***] at any time following Launch of the Licensed Product in [***], Chiesi has [***].
(ii) Protalix may terminate this Agreement in its entirety (or, at Protalix’s option, with respect to the applicable Country), in the event that Chiesi or any of its Affiliates (including through any acquisition), directly or indirectly, alone or in collaboration with any Third Party, Develop or Commercialize in any Country any Competing Product.
[***] Redacted pursuant to confidential treatment request.
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(a) Upon expiration or termination of this Agreement for any reason:
(i) Chiesi shall, promptly after such expiration or termination, provide to Protalix or its designee the following materials; provided that such materials shall be provided in the form and format in which such materials are maintained by Chiesi in the ordinary course of business (provided that Chiesi shall use Commercially Reasonable Efforts to provide such materials in a form and format useable by Protalix), and Chiesi shall not be required to prepare any new data, reports or information solely for purposes of transfer to Protalix:
(A) all regulatory filings, Regulatory Approvals, Price Approvals and Governmental Authority and Third Party reimbursement approvals to the extent related to the Drug Substance, Drug Product or Licensed Product;
(B) all pre-clinical and clinical data, reports and information (including drug master files) in Chiesi’s possession or control to the extent relating to a Licensed Product, Drug Product or Drug Substance;
(C) all reports, records, regulatory correspondence and other materials in Chiesi’s possession or control to the extent relating to the pre-clinical and clinical development of the Drug Substance, Drug Product or Licensed Product, and also including, if applicable, any information contained in the global safety database established and maintained by Chiesi for the Licensed Product; and
(D) all Product Marks actually used in commerce by Chiesi or its Affiliates for the Licensed Product, excluding the corporate or trade name or logo of Chiesi or its Affiliates.
(ii) Effective upon such expiration or termination:
(A) Chiesi hereby does (and shall) assign to Protalix, or a Protalix Affiliate identified by Protalix, all of Chiesi’s right, title and interest in and to the materials transferred or delivered or deliverable by Chiesi pursuant to Section 12.3(a)(i), including the goodwill attendant to any Product Marks, to the extent Chiesi Controls such materials; with respect to the Product Marks, Chiesi shall execute an assignment of such Product Marks in favor of Protalix and Protalix shall be responsible for recording such assignment with the appropriate governmental trademark authorities. Chiesi shall cooperate in facilitating such assignment and recordation by timely executing all necessary documents provided to it by Protalix;
(B) Chiesi hereby does (and shall) assign to Protalix any applicable sublicenses to the extent related to the Licensed Product and/or Third Party agreements, with respect to significant services to be performed by Third Parties to the extent related to the Licensed Product in the Field, unless Protalix has advised Chiesi that it will not require such assignment.
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(iii) Without limitation of the generality of the foregoing, the Parties shall use diligent efforts to complete the transition of the Commercialization of the Licensed Product in the Field in the Territory hereunder to Protalix (or its sublicensee or Third Party designee) as soon as is reasonably possible.
(b) Following any expiration or termination of this Agreement, each of Chiesi and Protalix shall, upon request of the other Party, return or destroy all Protalix Confidential Information and Chiesi Confidential Information, respectively, disclosed to it pursuant to this Agreement, including all copies and extracts of documents, as promptly as practicable following receipt of such request, except (i) that one (1) copy may be kept for the purpose of complying with continuing obligations under this Agreement and (ii) to the extent and for so long as necessary to perform its obligations or exercise its rights under this Section 12.2.
12.4 Following termination of this Agreement, other than termination by Protalix pursuant to Sections 12.1(b), 12.1(c), 12.1(d), 12.1(e), or 12.1(f), notwithstanding the termination of the licenses and rights granted by Protalix to Chiesi hereunder, Chiesi, its Affiliates and its Sublicensees shall have the right to continue to sell their existing inventories of the Licensed Product for a period not to exceed [***] after the effective date of such termination and Protalix shall continue to receive any amounts due hereunder in respect of such Net Sales, Direct Sublicensee Revenue A, Direct Sublicensee Revenue B and Sublicensee Net Sales, including any applicable Event Milestone Payments, or reconciliation amounts calculated in accordance with Section 4.6(h). Following termination of this Agreement (or, in the event of termination by Protalix pursuant to Sections 12.1(b), 12.1(c), 12.1(d), 12.1(e) or 12.1(f), following such [***] period), Chiesi, its Affiliates and its Sublicensees shall promptly return to Protalix or destroy (at Protalix’s sole discretion) all inventory of Licensed Products in its possession as of the effective date of termination (or as of the end of such [***] period, as applicable).
Section 13. INDEMNIFICATION AND INSURANCE
[***] Redacted pursuant to confidential treatment request.
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(a) Subject to Section 13.4, Protalix shall indemnify and hold harmless the Chiesi Indemnitees from and against any and all Damages which a Chiesi Indemnitee may incur or suffer arising out of any Third Party Product Claim to the extent caused by or arisen from any defect in the Manufacturing of the Licensed Product by Protalix.
(b) Subject to Section 13.4 and except to the extent provided in subsection (a) above, Chiesi shall defend, indemnify and hold harmless the Protalix Indemnitees from and against any and all Damages arising out of any Third Party Product Claims to the extent caused by or arising out of any sale, use, importation, storage, handling, distribution, offer for sale (or other Commercialization) or sale of Licensed Product in the Territory.
13.4 Defense Procedures; Procedures for Third Party Claims.
(a) For purposes of this Agreement, “Third Party Claim” means a Claim asserted by a Third Party (in no event to include any Affiliate of either Party) against a Party or any of its Affiliates, or any of their respective directors, officers, employees, consultants, contractors, sublicensees and agents. In the event a Third Party Claim is asserted with respect to any matter for which a Party or any of its Affiliates, or any of their respective directors, officers, employees, consultants, contractors, sublicensees and agents (the “Indemnified Party”) is entitled to indemnification hereunder, then the Indemnified Party shall promptly notify in writing the Party obligated to indemnify the Indemnified Party hereunder (the “Indemnifying Party”) thereof; provided, however, that no delay on the part of the Indemnified Party in notifying the Indemnifying Party shall relieve the Indemnifying Party from any obligation hereunder unless (and then only to the extent that) the Indemnifying Party is prejudiced thereby.
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(b) The Indemnifying Party shall assume direction and control of the defense, litigation, settlement, appeal or other disposition of the Third Party Claim (including the right to settle the Claim solely for monetary consideration) with counsel selected by the Indemnifying Party and reasonably acceptable to the Indemnified Party. The Indemnified Party shall have the right to join in (including the right to conduct discovery, interview and examine witnesses and participate in all settlement conferences), but not control, at its own expense, the defense of any Third Party Claim that the Indemnifying Party is defending as provided in this Agreement. Notwithstanding anything to the contrary contained herein, an Indemnified Party shall be entitled to assume the defense of any Third Party Claim with respect to the Indemnified Party, upon written notice to the Indemnifying Party, in which case the Indemnifying Party shall be relieved of liability under Section 13.1, as applicable, solely for such Third Party Claim and related Damages.
(c) Neither Party will enter into any settlement of any suit involving Licensed Products that materially affects the other Party’s rights or obligations with respect to the Licensed Product without the other Party’s prior written consent (which consent shall not be unreasonably withheld, delayed or conditioned). Without limiting the foregoing, the Indemnifying Party shall not, without the written consent of the Indemnified Party (which consent shall not be unreasonably withheld, delayed or conditioned), effect any settlement of any pending or threatened litigation in which the Indemnified Party has sought indemnification hereunder by the Indemnifying Party, unless such settlement involves solely monetary damages and includes an unconditional release of the Indemnified Party from all liability on Claims that are the subject matter of such litigation.
[***] Redacted pursuant to confidential treatment request.
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Section 14. GOVERNING LAW AND JURISDICTION
14.1 Governing Law. This Agreement shall be governed by and construed in accordance with the substantive Laws of the State of New York, without regard to conflicts of law rules. The provisions of the U.N. Convention on Contracts for the International Sale of Goods shall not apply to this Agreement.
(a) If any Dispute arises, either Party may provide written notice of the Dispute to the other Party and request negotiation between the executive officers of each Party (“Dispute Notice”). Within fifteen (15) days after the delivery of a Dispute Notice, the executive officers shall confer in person or by teleconference to attempt to settle the Dispute. All communication between such executive officers shall not be construed as an admission or agreement as to the liability of any Party, nor be admitted in evidence in any related arbitration, litigation, or other adversary proceeding.
(b) If, within thirty (30) days after the delivery of a Dispute Notice, the Parties are unable to resolve the Dispute in writing, upon written notice by any Party to the other Party, such Dispute shall be determined exclusively by arbitration in London, England, before a panel of three (3) arbitrators in accordance with the Rules of Arbitration of the International Chamber of Commerce (“ICC Rules”), except as modified herein.
(c) In any arbitration commenced pursuant to this Section 14.2:
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(i) There shall be three arbitrators, one of which shall be nominated by Protalix and another of which shall be nominated by Chiesi, as provided in the ICC Rules. The third arbitrator, who shall serve as the president of the tribunal, shall be jointly nominated by the two Party-nominated arbitrators within twenty (20) days of the date of confirmation of the second arbitrator by the ICC. Any arbitrator not timely nominated as provided herein shall be appointed by the ICC Court.
(ii) The seat of arbitration shall be London, England. The language of the arbitration shall be English. The Parties agree that the award rendered by the arbitral tribunal shall be final and binding and enforceable against the Parties and their respective assets in any court of competent jurisdiction. Unless determined otherwise by the arbitral tribunal, [***]. The arbitral tribunal shall not award any damages excluded by Section 13.6.
(iii) Any arbitration hereunder shall be confidential, and neither the Parties nor their agents shall disclose to any Third Party the existence or status of the arbitration, any information made known or documents produced in the arbitration not otherwise available to them or in the public domain, or any awards arising from the arbitration, except and to the extent that disclosure is required by applicable Law or is required to protect or pursue a legal right.
(iv) For any proceeding in aid of arbitration or for preliminary relief to preserve the status quo or avoid irreparable harm prior to the appointment of an arbitral tribunal, each Party irrevocably and unconditionally consents and submits to the exclusive jurisdiction and venue of the courts located in England, and waives, to the fullest extent possible, any objection to the laying of venue in such courts. The arbitral tribunal also shall have full authority to grant provisional remedies and to direct the Parties to request that any court modify or vacate any provisional, temporary or preliminary relief issued by a court hereunder.
(v) In any action pursuant to Section 14.2 and in any action with respect to any arbitration award obtained pursuant to this Agreement or to the enforcement of such an award, the Parties agree to accept service of process in the manner provided for notices in this Agreement, and to waive any other requirements for service of process in any jurisdiction to the fullest extent permitted by Law.
(vi) Each Party shall continue to perform obligations hereunder, when any bona fide Dispute is pending.
14.3 Expert Legal Determination.
(a) In the event that the Parties are unable to agree on an approach to an alleged breach or default by Protalix of a Third Party License (in accordance with Section 9.2(i)), the Parties shall jointly engage an agreed-upon, independent law firm of reputable stature with relevant licensing expertise (specifically in respect of life science agreements) in the relevant jurisdiction ("Joint Legal Counsel") to provide its legal opinion as to existence of, and liability in respect of, such alleged breach or default of such Third Party License ("Joint Legal Opinion").
[***] Redacted pursuant to confidential treatment request.
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(b) [***]. Communications with Joint Legal Counsel, its work product, and the Joint Legal Opinion shall be privileged and confidential and shall not be disclosed to anyone other than the Parties, who will be Joint Legal Counsel's joint clients, except that a Party may disclose the Joint Legal Opinion in confidence to a court or arbitration tribunal if necessary to enforce its rights under this Agreement.
(c) If the Joint Legal Counsel takes the position in the Joint Legal Opinion that the alleged breach or default exists and is able to quantify the amount of liability relating to such breach or default, Chiesi shall be entitled to (but not obligated to) exercise the right set out in Section 9.2(i) to undertake payment or performance of the underlying obligation on behalf of Protalix as necessary to cure such default or breach and to offset, against amounts payable to Protalix under this Agreement, any reasonable out-of-pocket costs and expenses incurred by Chiesi in the course thereof.
(d) If the Joint Legal Counsel takes the position in the Joint Legal Opinion that the alleged breach or default does not exist (or if the Joint Legal Counsel is unable to reach a conclusion in the Joint Legal Opinion as to the existence or otherwise of the alleged breach or default), then Chiesi may not exercise the right set out in Section 9.2(i), and such alleged breach or default may not be again referred for determination under this Section 14.3.
[***] Redacted pursuant to confidential treatment request.
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15.6 Assignment; Binding Effect.
(a) Neither this Agreement nor any rights or obligations of either Party to this Agreement may be assigned or otherwise transferred by either Party without the consent of the other Party; provided, however, either Party may, without such consent, assign this Agreement, in whole or in part: (i) to any of its respective Affiliates; provided that such assigning Party shall remain jointly and severally liable with such Affiliate in respect of all obligations so assigned, or (ii) to a Third Party successor to all or substantially all of the assets of such Party whether by merger, sale of stock, all or substantially all of a Party’s assets or other similar transaction, so long as such Third Party agrees in writing to be bound by the terms of this Agreement. Notwithstanding anything to the contrary herein, nothing herein shall prevent Protalix or Protalix Parent from engaging in any merger, consolidation, reorganization, sale or purchase of stock, or sale or purchase of assets, or undergoing any Change of Control.
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(b) Any purported assignment in violation of this Section 15.6 shall be void. Any permitted assignee shall assume all obligations of its assignor under this Agreement.
If to Protalix:
Xxxxx Xxxxx
X.X. Xxx 000,
Xxxxxxx 00000, Xxxxxx
with a copy to:
Xxxxx Xxxxxx
If to Chiesi:
Chief Executive Officer
Xxxxx X. Xxxxxxx, 00/X -
00000 Xxxxx, Xxxxx
with a copy to:
General Counsel; and
Head of Global Corporate Development
Notices hereunder shall be deemed to be effective (a) upon receipt if personally delivered, (b) on the tenth (10th) Business Day following the date of mailing if sent by registered or certified air mail and (c) on the second (2nd) Business Day following the date of transmission or delivery to the overnight courier if sent by facsimile or overnight courier. A Party may change its address listed above by sending notice to the other Party in accordance with this Section 15.8.
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[Signature Page Follows]
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CHIESI FARMACEUTICI S.p.A. | CHIESI FARMACEUTICI S.p.A. | |||
By: | /s/ Xxxxxxx Xxxxxx | By: | /s/ Ugo Di Francesco | |
Name: Xxxxxxx Xxxxxx | Name: Ugo Di Francesco | |||
Title: President | Title: Chief Executive Officer |
PROTALIX LTD. | ||
By: | /s/ Xxxxx Xxxxx | |
Name: | ||
Title: |
EXHIBIT A
PROTALIX PATENT RIGHTS
[***]
[***] Redacted pursuant to confidential treatment request.
EXHIBIT B
THIRD PARTY LICENSES
[***]
[***] Redacted pursuant to confidential treatment request.
EXHIBIT C
PRESS RELEASE
[***]
[***] Redacted pursuant to confidential treatment request.
EXHIBIT D
CHIESI ANTI-BRIBERY POLICY
[***]
[***] Redacted pursuant to confidential treatment request.
EXHIBIT E
CHIESI CODE OF ETHICS AND CONDUCT
[***]
[***] Redacted pursuant to confidential treatment request.
EXHIBIT F
SELECT MATTERS
[***]
[***] Redacted pursuant to confidential treatment request.
Schedule 3.1
CONFIDENTIAL DRAFT DEVELOPMENT PLAN
[***]
[***] Redacted pursuant to confidential treatment request.
Schedule 3.7
CONFIDENTIAL INITIAL DRAFT COMMERCIALIZATION PLAN
[***]
[***] Redacted pursuant to confidential treatment request.