Amended and Restated Exclusive License and Supply Agreement, dated January 17, 2020, by and between Celsee, Inc. and Zomedica Pharmaceuticals Corp
Certain identified information has been excluded from this exhibit because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed. [*] indicates that information has been redacted.
AMENDED AND RESTATED EXCLUSIVE LICENSE AND SUPPLY AGREEMENT
This Amended and Restated Exclusive License and Supply Agreement (this “Agreement”), dated as of January 17, 2020 but made effective January 1, 2020 (“Effective Date”), is made by and between Celsee, Inc. (“Celsee”), a Delaware corporation having a business address at 100 Phoenix Drive, Suite 321, Ann Arbor, MI 48108, USA, and Zomedica Pharmaceuticals Corp. (“Zomedica”), a Canadian corporation having a business address at 100 Phoenix Drive, Suite 190 Ann Arbor MI 48108 USA Each of Celsee and Zomedica may be referred to herein as a “Party” or together as “Parties”.
|A.||Celsee has proprietary microfluid technology for processing samples and isolating circulating tumor cells (“CTCs”) for Oncology/Immuno-Oncology life science and clinical research applications including for diagnostic purposes and develops, manufactures, and markets innovative, integrated microfluidic systems for same.|
|B.||Zomedica is a veterinary pharmaceutical and health care solutions company creating innovative products for companion animals (canine, feline and equine) including veterinary-approved drugs, novel drug-delivery technologies, diagnostics, and which has expertise and know-how in developing products for applications in the veterinary field.|
|C.||The Parties entered into a Collaborative Research Agreement of January 3, 2017 (“CRA”), and a License and Supply Agreement dated December 20, 2017 (the Original Agreement”) to develop consumable CTC assay materials for detection of companion animal cancers from blood with such consumables consisting of at least the Celsee Immunochemistry Consumable Package (without antibodies) and which may also include Zomedica antibody sets and/or biomarkers (inclusive of antibodies, the “CTC Consumable Package”).|
|D.||The parties now desire to amend and restate the Original Agreement in its entirety as set forth herein|
NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants set forth in this Agreement, the consideration given, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound, hereby agree as follows:
The following terms and their correlatives have the following meanings:
1.1 “Affiliate” means any corporation or other entity which directly or indirectly controls, is controlled by or is under common control with a Party, for so long as such control exists. For the purposes of this Section 1.1 (“Affiliate”), “control” shall mean: (i) in the case of any corporate entity, direct or indirect ownership of more than fifty percent (50%) of the stock having the right to vote for the election of directors thereof or (ii) in the case of any non-corporate entity, direct or indirect ownership of more than fifty percent (50%) of the equity or income interest therein.
1.2 “Agreement” has the meaning set forth in the Preamble and includes this Agreement and any schedules, appendices and development plan(s).
1.3 “Arbitrator” has the meaning set forth in Section 15.4.
1.4 “Background Intellectual Property” means the Intellectual Property created or Controlled by a Party prior to the Effective Date of this Agreement.
1.5 “Bankruptcy Laws” has the meaning set forth in Section 13.3(b)(i).
1.6 “BIA” has the meaning set forth in Section 13.3(b)(i).
1.7 “Business Day” means any day that is not a Saturday, Sunday, or statutory holiday in the state of Michigan.
1.8 “Calendar Quarter” means a quarter of the year, the first Calendar Quarter ending March 31 of each year, the second on June 30 of each year, the third on September 30 of each year and the fourth on December 31 of each year.
1.9 “Calendar Year” means the calendar year, commencing at the beginning of the first Calendar Quarter and ending the end of the fourth Calendar Quarter.
1.10 “Celsee Controlled Patent Right” means a Patent Right that is Controlled by Celsee.
1.11 “Celsee Controlled Technology” means Technology Controlled by Celsee including Celsee Owned Intellectual Property, and Celsee Controlled Patent Rights.
1.12 “Celsee Core Technology” means the Celsee CTC Platform Technology, collectively with the Celsee Immunochemistry Consumable Package.
1.13 “Celsee’s CTC Platform Technology” means Celsee’s proprietary instruments as set forth in Schedule A, and software and Technology related thereto.
1.14 “Celsee Consumable Package” means the consumables (Kits) set forth in Schedule A.
1.15 “Celsee Field” means all fields of use other than the Zomedica Field, including, but not limited to, all human health and human diagnostic applications, veterinary research, and other veterinary care outside of the Zomedica Field.
1.16 “Celsee Indemnitees” has the meaning set forth in Section 12.2.
1.17 “Celsee Owned Intellectual Property” is the Intellectual Property owned by Celsee as set out in Section 8.2.
1.18 “Celsee Parties” has the meaning set forth in Section 12.1(a).
1.19 “CCAA” has the meaning set forth in Section 13.3(b)(i).
1.20 “Change of Control” means, with respect to a Party, (a) a merger, reorganization, or consolidation of a Party with or into any Third Party, or any other corporate reorganization involving such a Third Party, that results in those persons or entities that are stockholders of a Party immediately prior such merger, reorganization, or consolidation owning less than fifty percent (50%) of the surviving entity’s voting power immediately after such merger, reorganization, or consolidation, (b) a change in the legal or beneficial ownership of fifty percent (50%) or more of the combined voting power of the outstanding securities of a 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 a Party is a Third Party or (c) the sale, transfer, lease, license or other disposition to a Third Party of all or substantially all of a Party’s business or assets to which this Agreement relates in one or a series of related transactions; provided that a “Change of Control” shall not include any Change of Control required by a government or the requirements of applicable Law or a transaction or series of transactions undertaken principally undertaken for bona fide equity financing purposes.
1.21 “Clinical Validation” means the successful testing by Zomedica with at least one veterinary cancer type of the customized CTC Consumable Package and Celsee Platform Technology for use in the Zomedica Field, across a sample of sufficient size and rigor to support the diagnostic sensitivity and specificity of the product for marketing purposes as determined by Zomedica in its sole discretion.
1.22 “Collaboration Product” means a veterinary clinical cancer diagnostic product developed pursuant to the Development Plan or this Agreement including CTC Consumable Package(s) and Celsee’s CTC Platform Technology modified or adapted for use in the Zomedica Field as set forth in Schedule A.
1.23 “Commercially Reasonable Efforts” of a Party means, with respect to an obligation of a Party to accomplish an objective under this Agreement, the efforts and resources comparable to those undertaken by a veterinary pharmaceutical company of comparable size and resources in the case of Zomedica or a biopharmaceutical or biotechnology company of comparable size and resources in the case of Celsee relating to the research, development, manufacture or commercialization of a similar product owned by such company, or to which such company has exclusive rights, with comparable market potential and is at a similar stage in its lifecycle. For this purpose, all relevant factors, as measured by the facts and circumstances at the time such efforts are due, shall be taken into account, including, as applicable and without limitation, stage of development; efficacy and safety relative to competitive products in the marketplace; actual or anticipated Regulatory Approval; labeling; the nature and extent of market exclusivity (including patent coverage, proprietary position and regulatory exclusivity), product pricing and reimbursement; and the cost and time required for and likelihood of obtaining Regulatory Approval and commercializing a product.
1.24 “Confidential Information” has the meaning set forth in Section 9.1 (Confidentiality; Exceptions).
1.25 “Contract Interest Rate” means the lesser of:
(a) the Wall Street Journal prime rate of interest ; and
(b) the maximum rate permitted by Michigan Law.
1.26 “Control” means, with respect to any Information, Patent Right or other intellectual property right, the possession (whether by ownership or license) by a Party or its Affiliate of the conditional or unconditional ability to grant to the other Party access, ownership, a license or a sublicense as required herein (including without limitation pursuant to a power of attorney) to such Information, Patent Right, or other intellectual property right without violating the terms of any agreement or other arrangement with any Third Party in existence as of the Effective Date. In the case that the ability to grant is conditional (as with certain sublicenses), Control will require that the other Party be able to and agrees to satisfy such condition(s).
1.27 “Covers” or “Covering”, with reference to a Patent Right, means that the making, using, selling, offering for sale or importing of a composition of matter, process or other material or practice of a claimed method would, but for ownership of or a license under such Patent Right, comprise an infringement (including contributory or inducement) of a Valid Claim (or, if such Valid Claim has not issued, if such Valid Claim were to issue), within such Patent Right in the country in which such activity occurs.
1.28 “CTC Consumable Package” means a package of CTC assay consumables (Kits) as set forth in Schedule A.
1.29 “Development” or “Develop” means non-clinical and clinical development activities pertaining to a Collaboration Product, including, but not limited to, antibody identification and testing, protocol optimization, software optimization, process and manufacturing development, quality assurance and quality control development, statistical analysis, and clinical studies.
1.30 Intentionally Omitted
1.31 “Development Plan” means the written plan for Developing and validating Collaboration Products, as set forth in the Development Plan Schedule of the Original Agreement which Development Plan has been completed with all payments due thereunder having been made.
1.32 “Dispute” has the meaning set forth in Section 14.1.
1.33 “Dollars” means U.S. Dollars, and “$” shall be interpreted accordingly.
1.34 “Effective Date” has the meaning set forth in the Preamble.
1.35 “Force Majeure” has the meaning set forth in Section 15.7 (Force Majeure).
1.36 “Indemnified Party” has the meaning set forth in Section 12.3.
1.37 “Indemnifying Party” has the meaning set forth in Section 12.3.
1.38 “Indemnify” has the meaning set forth in Section 12.1.
1.39 “Information” means all information not generally known to the public, including tangible and intangible techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, know-how, conclusions, skill, experience, test data and results (including pharmacological, toxicological, manufacturing, and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms, including works of authorship and copyrights.
1.40 “Insolvency Event” has the meaning set forth in Section 13.3(a).
1.41 “Insolvent Party” has the meaning set forth in Section 13.3(b)(ii).
1.42 “Intellectual Property” means Patent Rights, trade secrets, copyrights (and associated moral rights), trade-marks (and associated goodwill), industrial designs, domain names, Know-How and other forms of proprietary or industrial rights pertaining to inventions, original works and other forms of intellectual property.
1.43 “Know-How” means all techniques, technical information, technology practices, research tools and platforms, trade secrets, inventions (whether patentable or not), methods, processes of manufacture, methods for isolation of CTCs, data and results (including pharmacological, toxicological and preclinical and clinical test data and results), analytical and quality control data, software including in source code or object code form) and algorithms now or hereafter Controlled by the Parties.
1.44 “Law” means, individually and collectively, any and all applicable laws, statutes, regulations, treaties, judgments, decrees, ordinances, rules, rulings, directives, and administrative circulars, (and whether or not having the force of law) all applicable consents, approvals, by-laws, permits, authorizations, guidelines, orders and policies of any kind whatsoever of any governmental authority or Regulatory Authority within the applicable jurisdiction.
1.45 “Losses” has the meaning set forth Section 12.1.
1.46 “Materials” means any tangible instrument, property, chemical or biological material.
1.47 “Party” and “Parties” has the meaning set forth in the Preamble.
1.48 “Patent Right” means any and all rights in patents which are defined as:
(b) pending patent applications, including, all provisional applications, substitutions, continuations, continuations-in-part, divisions and renewals and all patents granted thereon;
(c) all patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including, supplementary protection certificates or the equivalent thereof;
(d) inventor’s certificates;
(e) any other form of government-issued right substantially similar to any of the foregoing; and
(f) all U.S. and foreign counterparts of any of the foregoing, collectively, (a) to (f) being “Patents”.
1.49 “Post Term Period” has the meaning in Section 13.5.
1.50 “Prosecution and Maintenance” means, with respect to a Patent Right, the preparing, filing, and prosecuting of patent applications and maintenance of patents, as well as re-examinations, and reissues, with respect to such patents, together with the conduct of interferences and the defense of oppositions with respect to the particular patent application or patent; and “Prosecute and Maintain” have the correlative meaning.
1.51 “Regulatory Authority” means, with respect to a country, the regulatory authority or regulatory authorities of such country with authority over this Agreement and activities contemplated hereunder including the testing, manufacture, use, storage, importation, promotion, marketing, pricing or sale of a diagnostic product or Collaboration Product in such country.
1.52 “Senior Executives” has the meaning set forth in Section 14.1.
1.53 “Taxes” means any present or future taxes, levies, imposts, duties, charges, assessments or fees of any nature (including any interest thereon).
1.54 “Technology” as used herein includes all Intellectual Property and associated Rights, all Information, Confidential Information, Know-How and Materials.
1.55 “Term” has the meaning set forth in Section 13.1.
1.56 “Territory” means the world.
1.57 “Third Party Claim” has the meaning set forth in Section 12.1.
1.58 “Third Party” means any entity other than a Party or an Affiliate of a Party.
1.59 “United States” or “U.S.” means the United States of America, including its territories and possessions, the District of Columbia and Puerto Rico.
1.60 “Valid Claim” means, with respect to a particular country:
(a) any claim of an issued and unexpired Patent Rights in such country that:
(i) has not been held permanently revoked, unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction, which decision is unappealable or unappealed within the time allowed for appeal; and
(ii) has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise in such country; or
(iii) a claim of a pending patent application where such claim has been pending for a period of ten (10) years or less.
1.61 “VAT” means the goods and services tax and the harmonized sales tax or other value added tax imposed by Applicable Laws.
1.62 “Zomedica” shall have the meaning set forth in the Preamble.
1.63 “Zomedica Field” means all veterinary oncology care.
1.64 “Zomedica Owned Intellectual Property” means Intellectual Property owned by Zomedica as noted in Section 8.
1.65 “Zomedica Indemnitees” has the meaning set forth in Section 12.1.
1.66 “Zomedica Parties” has the meaning set forth in Section 12.2(a).
1.67 “Schedules” The following schedules are (or will be once agreed to between the Parties) attached to and form part of this Agreement:
Schedule A – Collaboration Product Pricing
Schedule B – Celsee Patent Rights
Schedule C – Compliance Schedule/Code of Conduct
Schedule D – Customer Service Agreement
Schedule E – Quality Control
(a) The definitions of the terms herein apply equally to the singular and plural forms of the terms defined.
Certain identified information has been excluded from this exhibit because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed. [*] indicates that information has been redacted.
(b) Whenever the context may require, any pronoun includes the corresponding masculine, feminine and neuter forms.
(c) The words “include”, “includes” and “including” are deemed to be followed by the phrase “without limitation.”
(d) The word “will” is construed to have the same meaning and effect as the word “shall.”
(e) Unless the context requires otherwise,
(i) any definition of or reference to any agreement, instrument or other document herein will be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein),
(ii) any reference to any Laws herein will be construed as referring to such Laws as from time to time enacted, repealed or amended,
(iii) any reference herein to any person will be construed to include the person’s permitted successors and assigns,
(iv) the words “herein”, “hereof” and “hereunder”, and words of similar import, will be construed to refer to this Agreement in its entirety and not to any particular provision hereof, and
(v) all references herein to Articles, Sections or Schedules, unless otherwise specifically provided, will be construed to refer to Articles, Sections or Schedules of this Agreement.
|2.||Development Plan; Exclusivity|
2.1 Exclusivity. During the Term or in the event this Agreement is terminated by Zomedica as a result of an uncured material breach by Celsee pursuant to Section 13.2(a)(i) for a period [*] thereafter, Celsee and its Affiliates shall not, directly or indirectly, without the prior written consent of Zomedica:
(a) conduct or continue any research or development of any new or existing products for use in Zomedica’s Field, alone or in collaboration with or for the benefit of any Third Party (including any governmental agency) for the purposes of commercialization, use, manufacture or distribution of CTC Consumable Packages or any other products utilizing Celsee’s CTC Platform Technology in the Zomedica Field; provided however that this prohibition shall not apply solely to research in the Zomedica Field conducted pursuant to funding received from government grants;
(b) except pursuant to the Development Plan, Develop or commercialize any product in the Zomedica Field, alone or in collaboration with or for the benefit of any Third Party (including any governmental agency);
(c) collaborate with, license, enable or otherwise authorize or grant rights to any Third Party under the Intellectual Property or any other Celsee Core Technology or Celsee Controlled Technology or Celsee’s CTC Platform Technology to use, develop, commercialize or manufacture products in the Zomedica Field, other than Third Party subcontractors to the extent permitted under Section 2.2, or enter into any agreement, amendment to an existing agreement or option to do any of the same; or
(d) grant any right to any Third Party in the Zomedica Field that would impair or conflict in any way with any of the rights granted to Zomedica under this Agreement; and
(e) notwithstanding any of the foregoing and for clarity, subject to Section 9.1(b) and Section 9.2, Celsee, its Affiliates, and all other non-profit academic research institutions with whom it may contract from time to time, shall not be restricted from conducting any non-clinical Development activities for non-commercial purposes or for profit research with contract research organizations for the sole purpose to develop and commercialize products outside the Zomedica Field, including veterinary research, veterinary clinical diagnostics for indications other than cancer, and human clinical research.
2.2 Permitted Subcontracting.
(a) Each Party may subcontract any of its activities to be performed under the Development Plan to a Third Party or to an Affiliate of the Party, provided that any such Third Party or Affiliate shall have entered into a written agreement with such Party that includes terms and conditions protecting and limiting use and disclosure of Confidential Information, Materials and Information of the other Party at least to the same extent as under this Agreement or, in the case of such Affiliate, such Affiliate is subject to similar obligations of non-use and non-disclosure, and requiring such Third Party or Affiliate, as applicable, and its employees, contractors and agents to grant such Party Control in and to any Patent Rights, Information and Materials created, conceived or reduced to practice in connection with the performance of any such subcontracted activities.
(b) Each Party shall remain responsible and liable for the performance by its Affiliates and subcontractors of its obligations hereunder, and shall cause its Affiliates and subcontractors to comply with the provisions of this Agreement, including, causing such Third Parties to make any and all assignments of intellectual property rights generated in carrying out a Party’s obligation in accordance with the terms of this Agreement.
Certain identified information has been excluded from this exhibit because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed. [*] indicates that information has been redacted.
|4.||Manufacturing and Supply|
4.1 Branding. The Collaboration Product will display branding determined by Zomedica for the veterinary diagnostics market. To the extent possible and as allowed by applicable Laws, Celsee’s brand will also be displayed on the Collaboration Product components.
4.2 Manufacturing and Product Supply.
(a) During the Term, Celsee shall exclusively supply the Collaboration Products to Zomedica for resale to customers of Zomedica solely for use in the Zomedica Field.
(b) Zomedica shall issue to Celsee from time to time, purchase orders which shall confirm the quantity and shipping arrangement for the Collaboration Products. This Agreement shall contain all terms and conditions regarding the sale of Collaboration Products and any terms in Zomedica’s purchase orders which are inconsistent with the terms of this Agreement shall be of no force and effect. Delivery Dates for the Collaboration Products will be [*] and for the CTC Consumable Package will be [*] after the purchase order is delivered to Celsee. Zomedica shall be responsible for supply of the antibody cocktail or biomarkers, if any, for inclusion in the CTC Consumable Package used in the Collaboration Products at no cost to Celsee. Zomedica shall be responsible for sales of Collaboration Products to customers, for invoicing customers and for collecting receivables related to Collaboration Products in a timely fashion. All undisputed invoices for Collaboration Products shall be provided by Celsee to Zomedica following product shipment and shall be due and payable in full within [*] of the date the invoice is received.
(c) Celsee will manufacture and supply the Collaboration Products at agreed upon supply prices as noted in Section 7.4 to Zomedica, which shall be subject to adjustment as provided in this Agreement. All Collaboration Products shall be manufactured in accordance with applicable Laws and meet all specifications for the Collaboration Products.
(d) Within 30 days of the Effective Date and [*] prior to the commencement of each calendar quarter during the Term and the Post Term Period, Zomedica shall provide a rolling non-binding 12 month forecast of its supply requirements for Collaboration Products (the “Forecast”). Celsee will use Commercially Reasonable Efforts to maintain sufficient capacity to meet all supply requirements of Zomedica and its customers for the Collaboration Products based on the Forecast. Celsee will use Commercially Reasonable Efforts to supply the Collaboration Products, CTC Platform or CTC Consumable Packages in excess of [*] of Forecast amounts. Celsee shall promptly notify Zomedica in writing if at any time Celsee has reason to believe (i) that it will not be able to fill a purchase order in accordance with the delivery schedule specified therein and pursuant to the terms of this Agreement or (ii) supply Collaboration Products, the Celsee Platform equipment or CTC Consumable Package in satisfaction of the most recent Forecast which notice in either event shall provide Zomedica with information on the extent of the
expected shortfall. Upon receipt of such notice, the Parties shall immediately meet and work together in good faith to identify an appropriate resolution to the supply shortfall.
(e) Zomedica shall have [*] business days from receipt of each delivery of Collaboration Products to inspect the delivery for a shortfall, and to inspect the Collaboration Products packaging for visible defects. Zomedica may notify Celsee of a shortfall, or reject visibly defective Collaboration Products, within [*] days of such inspection. Upon notice to Celsee of a shortfall or defect, Celsee shall deliver the shortfall amount as soon as commercially possible. Zomedica may request expedited (e.g., overnight) shipment of such shortfall delivery and Celsee shall be responsible for the cost of such expedited shipment.
(f) Celsee shall package the Collaboration Products in containers suitable to ensure that the Collaboration Products will not be damaged in the ordinary course of delivery. Shipment shall be made EXW Celsee’s dock. Celsee shall arrange for the shipment of the Collaboration Products to Zomedica in accordance with Zomedica’s instructions (e.g., use of Zomedica’s freight account, insurance, etc.), and Zomedica shall pay the cost of shipping as reflected in the corresponding Collaboration Products invoice. Celsee will perform, at Celsee’s expense, quality control testing on all Collaboration Products in accordance with normal industry standards, as detailed in Schedule E. Contemporaneous with each shipment of Collaboration Products hereunder, Supplier will provide Company with a Certificate of Analysis with respect to such Collaboration Product confirming that the Collaboration Products have undergone quality control testing.
(g) Celsee shall promptly notify Zomedica of any anticipated changes to the Collaboration Products or any components thereof, and shall also notify Zomedica of proposed changes to the Quality Control processes documented in Schedule E. The Parties shall use Commercially Reasonable Efforts to accommodate and integrate any necessary changes, with the goal of minimizing the commercial impact on the Collaboration Products.
|5.||Marketing, Customer and Product Support|
5.1 Zomedica will be solely responsible for marketing the Collaboration Products in the Zomedica Field.
5.2 Zomedica will be responsible for warehousing of the Collaboration Products inventory, and for sales of and shipping of such products to end customers. The Parties understand and agree that during the Term, Celsee’s warehouse will be available for inventory..
5.3 Once a product is sold to a customer, Zomedica will be responsible for providing training and first-tier customer support. Celsee will provide training to necessary Zomedica employees, as well as materials to be used in providing training for Zomedica customers. Any Collaboration Product or software-related support in the United States will be provided by Celsee without charge, with the parties’ specific support responsibilities as enumerated in Schedule D.
Celsee will provide necessary training at an agreed rate to Zomedica distributors outside the United States.
5.4 Warranty and Limitations.
(a) Limited Warranty. Celsee shall be responsible for all warranty work, refunds and repairs with respect to the CTC Platform and shall be entitled to retain all revenues from extended warranty or service contracts in the United States between Celsee and any customers of Zomedica. Celsee warrants all instruments and Collaboration Products will be free from defects in materials or workmanship under normal use for a period of [*] from shipment to Zomedica and all consumables will be free from defects in materials or workmanship under normal use and proper storage conditions for [*] from shipment to Zomedica or the stated Celsee shelf life for consumables. The warranty shall not apply to any defects directly attributable to antibody sets or biomarkers provided by Zomedica. In addition, the warranty shall not apply to any Collaboration Product used for a purpose or in a manner for which it was not intended, which is not used in accordance with instructions for use, which is altered in any way, or which is subject to misuse, negligence, accident or neglect. Celsee’s obligation with respect to this warranty is limited to the replacement of defective Collaboration Products after inspection and verification of such defects. Zomedica will responsible to the customer for any warranty beyond the warranty provided herein.
(b) Celsee’s warranty obligations under this Section 5.4 are subject to Zomedica’s compliance with the following procedures:
(i) The Products are sold by Zomedica in the Zomedica Field.
(ii) Upon identification of a defect covered under Celsee’s warranty, Zomedica will notify Celsee of the product SKU and lot number of the allegedly defective Collaboration Product with a description of the problem or defect.
(iii) Celsee shall notify Zomedica if the allegedly defective Collaboration Product should be returned and, if so, will issue a Celsee return merchandise authorization (RMA) number with respect to the claim.
(iv) Any items returned to Celsee under warranty pursuant to an RMA are to be sent freight prepaid. In the event that Celsee determines that the Collaboration Product need not be returned, the Collaboration Product shall be destroyed by Zomedica or the customer.
(v) Celsee shall provide replacement of the returned Collaboration Products that are determined to be defective, in Celsee’s sole discretion, at no charge to Customer.
5.5 Additional extended warranties in United States can be purchased from Celsee at [*] per instrument per year. Extended warranties outside the United States will be the responsibilities of Zomedica or its distributors, with any necessary training to be provided by Celsee. Zomedica shall be responsible for any warranties given to its customers beyond those in Section 5.4. All customer warranties shall contain customary limitations of liability and damage limitations protecting both Zomedica and Celsee.
5.6 Replacement parts for warranty work performed outside of the U.S. will be provided by Celsee, with the requirement that any defective parts shall be returned to Celsee as part of the warranty/repair process.
6.1 During the Term and the Post Term Period of the Agreement, each Party grants to the other a non-exclusive license for the Territory in their respective Intellectual Property to the extent necessary to develop and manufacture Collaboration Product(s) and for no other purposes.
6.2 During the Term of this Agreement, Celsee herein grants Zomedica an exclusive (other than during the Post Term Period detailed in Section 13.5 or as otherwise expressly set forth herein) fully paid up license in the Territory (even as to Celsee), to all Celsee Controlled Technology and Celsee Core Technology related to the Collaboration Product(s), including the Celsee CTC Platform Technology and CTC Consumable Package(s), to commercialize, Develop or otherwise exploit, market, sell and distribute Collaboration Products solely in the Zomedica Field. For clarity, any other field of use or applications other than the Zomedica Field is excluded from the license granted herein.
7.1 Execution and Milestone Payments.
(a) The Parties acknowledge and agree that pursuant to the Original Agreement and prior to the Effective Date hereof, each of the following payments have been made by Zomedica to Celsee::
(i) A lump-sum one-time cash payment of $250,000 in consideration of Celsee’s efforts toward [*].
(ii) A second lump-sum one-time cash payment of $250,000 to assist Celsee in [*].
(iii) A lump-sum one-time payment of $250,000, with such payment to be in the form of common shares in Zomedica. The number of common shares to be issued to Celsee shall be determined by the following formula: number of common shares =
$250,000/volume-weighted average price of Zomedica stock over the previous 10 days. This price shall be measured on the NYSE American exchange.
(b) In addition, pursuant to a Debt Conversion Agreement dated January 11, 2019, Zomedica has fully satisfied the milestone payments set forth in section (i) and (ii) below through the issuance to Celsee of Common Shares upon achievement of the following milestones, which the Parties acknowledge and agree that pursuant to the Original Agreement and prior to the Effective Date hereof, each of the following milestones have been achieved Celsee:
(i) Upon completion of product development [*] as determined by Zomedica in its sole discretion, Zomedica will (x) make a one-time payment of $250,000 to Celsee, with such payment to be in the form of common shares in Zomedica. The number of common shares to be issued will be determined in accordance with the formula in Section 8.1(a)(iii) above and (y) make an additional one-time payment of $250,000 in cash to Celsee.
(ii) Upon successful completion of the transfer by Celsee to a streamlined manufacturing process [*] for the Collaboration Product as determined by Zomedica in its sole discretion, Zomedica will (x) make a one time payment of $250,000 to Celsee, with such payment to be in the form of common shares in Zomedica. The number of common shares to be issued will be determined in accordance with the formula in Section 8.1(a)(iii) above and (y) an additional one time payment of $250,000 in cash to Celsee upon achievement of this milestone. The payments hereunder shall be made within [*] of the date of completion of the payment milestone.
7.2 Registration of Securities.
(a) As of the Effective Date, the securities issued pursuant to the Original Agreement and Debt Conversion Agreement have been registered under the Securities Act of 1933, as amended, or state securities laws with Zomedica having filed a registration statement to register securities from this agreement for resale in the United States.
7.3 Change of Control.
In the event of Zomedica Change of Control or the acquisition, sale or other assignment of all or substantially all of the Zomedica business to which the Agreement relates, unless otherwise agreed, all outstanding payments for Collaboration Products payable under Section 7.4 below which have not yet been paid shall become immediately due upon the closing of such transaction.
7.4 Payments for Supply
(a) Celsee shall supply Collaboration Products to Zomedica in accordance with the Supply Prices set forth on Schedule A.
7.5 Records and Audits. Celsee shall keep (and shall cause its Affiliates and sublicensees and subcontractors to keep) complete and accurate books and records of accounting pertaining to the amounts due and payable and or any applicable costs and expenses hereunder, in sufficient detail to permit Zomedica to confirm accuracy of all payments due hereunder. For the seven (7) years following the later of (a) the termination of this Agreement in accordance with its terms and (b) the completion of the Development Plan, such books and records of accounting shall be kept at each of their principal place of business and no more than once per Calendar Year (unless Zomedica is required to respond to or by a Government Authority) will be open for inspection during normal business hours and upon prior written notice by an independent certified accountant selected by Zomedica at Zomedica’s expense, and which is reasonably acceptable to Celsee, for inspecting the payments made by Zomedica under this Agreement. Such accountant shall have executed and delivered to Celsee, a customary confidentiality agreement as reasonably requested by Celsee. The results of such inspection, if any, will be shared by the accountant with Zomedica and Celsee at either of Celsee’s or Zomedica’s request, and are binding on both Zomedica and Celsee.
7.6 Currency Used and Exchange Rates. All currency amounts in this Agreement are expressed in US Dollars and all payments to be made by Zomedica to Celsee under this Agreement shall be made in US Dollars by wire transfer in immediately available funds to a bank and account designated Celsee herein. When conversion of amounts received by Zomedica in any currency other than Dollars is required, such conversion shall be calculated using the rate of exchange using the following methodology:
(a) Calculations of sales and costs required by this Agreement will be made in United States Dollars regardless of the countries in which these sales or costs occur. Net Sales or Costs of Manufacture made in currencies other than Dollars will be converted into Dollars using a fixed exchange rate (subject to periodic adjustments as described below).
(b) Exchange rates for all payments under this Agreement will be fixed as of September 30th for a period of twelve (12) months forward, which is to commence the first business day of the next Calendar Year. The exchange rates will be fixed based on the close price exchange rates published in the Wall Street Journal for September 30th, where “close price” refers to the United States dollar/foreign currency exchange rates as published by the Wall Street Journal for September 30th (or the next business day if rates for September 30th are unavailable) of a given year.
(c) Exchange rates will reset annually based again on the applicable close price exchange rates. The reset exchange rates shall apply to all payments based on Net Sales after the reset date for the next twelve-month period and in no event shall such reset exchange rates be applicable to payments based on Net Sales in prior periods.
(a) Zomedica shall be responsible for collection and remittance of taxes on the sale of Collaboration Products by Zomedica to its customers. Zomedica will make all payments to Celsee under this Agreement without deduction or withholding for Taxes except to the extent that any such deduction or withholding is required by Law in effect at the time of payment. The Parties agree to use commercially reasonable efforts to minimize any withholding or similar Tax imposed upon payments payable under this Agreement and to consult in good faith before taking any action that is reasonably expected to result in the application of a withholding or similar Tax imposed upon payments payable under this Agreement.
(b) Any Tax required to be withheld on amounts payable under this Agreement will promptly be paid by Zomedica on behalf of Celsee to the appropriate governmental authority, and Zomedica will furnish Celsee with proof of payment of such Tax. Any such Tax required to be withheld will be an expense of and borne by Celsee.
(c) If Zomedica had a duty to withhold Taxes in connection with any payment it made to Celsee under this Agreement and Zomedica paid such Taxes (the “Assessed Amount”), then Zomedica will notify in writing it paid such Taxes, which notice will be a copy of the assessment and proof of payment including any other relevant documentation. Zomedica may offset the Assessed Amount against the immediately following payments owing to Celsee until such Assessed Amount has been fully satisfied.
(i) Zomedica and Celsee will cooperate with respect to all documentation required by any taxing authority or reasonably requested by Zomedica to secure a reduction in the rate of applicable withholding taxes. On the date of execution of this Agreement, Celsee shall provide any tax forms required to be completed for this transaction, including if applicable deliver to Zomedica an accurate and complete Internal Revenue Service Form W-8BEN-E certifying that Celsee is entitled to the applicable benefits under the Income Tax Treaty between Canada and the United States.
(ii) All payments due to Celsee from Zomedica pursuant to this Agreement shall be paid exclusive of VAT and similar commodity taxes. To support the zero-rating treatment for VAT purposes of any services, intellectual property rights or intangible personal property supplied by Celsee to Zomedica herein.
7.8 Manner of Payment. All payments to be made by a Party to another Party hereunder shall be in U.S. dollars by wire transfer to the relevant bank account detailed below or such other bank account as a Party (as applicable) may designate in writing from time to time during the Term
8.1 Publication. Without limitation of Section 9, neither Party shall publish or disclose any data or other Information arising from the Development Plan or related to the Collaboration Projects without scientific review and prior written approval by the other Party, provided that such restrictions shall not apply to the information a Party owns or Controls.
8.2 Ownership of Intellectual Property.
Ownership of Intellectual Property under this agreement shall be determined as follows:
(a) Each Party shall retain ownership over its Background Intellectual Property.
(b) All Intellectual Property independently or jointly developed by Celsee or Zomedica that is derived from or was developed using the Celsee Core Technology or that constitutes an improvement to the Celsee Core Technology will be owned by Celsee; provided however that any such Intellectual Property shall be subject to and included in the License granted Zomedica hereunder.
(c) All Intellectual Property independently developed by Zomedica on or after the Effective Date, and which is not based on or derived from the Celsee Core Technology and not encompassed in Section 8.2(b) will be the exclusive property and owned by Zomedica.
(d) Except as set form in (b) and (c) above, any Intellectual property developed independently by either Party subsequent to the Effective Date shall be owned by the Party that created such Intellectual Property.
(e) Any other Intellectual property jointly developed or invented will be jointly owned by Celsee and Zomedica (“Joint Intellectual Property”). Zomedica shall have fully paid-up, royalty-free, worldwide exclusive rights use any of such Joint Intellectual Property in the Zomedica Field, and Celsee shall have fully paid-up, royalty-free worldwide exclusive rights to use any of such Joint Intellectual Property in the Celsee Field.
8.3 Invention Disclosure.
Each Party shall promptly disclose to the other Party all inventions arising from the Development Plan that it and any of its Affiliates or subcontractors discovers or reduces to practice in performing the activities contemplated in the Development Plan or that relates to a Collaboration Product, its manufacture, use or sale except that nothing herein shall require disclosure of Celsee Core Technology independent of the Collaboration Product.
8.4 Prosecution of Patents.
(a) Subject to 8.4(b) each Party shall be responsible for the Prosecution and Maintenance and costs of all Patent Rights it owns using counsel chosen by them.
(b) Consultation. With respect to Celsee Controlled Patent Rights that are licensed to Zomedica, Celsee shall provide Zomedica with copies of all substantive documents relating to the Prosecution and Maintenance of said Patent Rights if desired by Zomedica and provide Zomedica with a reasonable opportunity to provide comments related to the prosecution of such Patent Rights.
8.5 Infringement of Third-Party Patent Rights. The Parties shall use reasonable efforts to avoid infringing or misappropriating any Third Party’s Intellectual Property Rights in conducting any activities under this Agreement. Each Party shall promptly notify the other in the event it becomes aware of any patent rights controlled by a Third Party that may pertain to any such activities of the Parties.
8.6 Enforcement of Intellectual Property Rights.
(a) Notification. If a Party becomes aware of any infringement, threatened infringement, or alleged infringement of either Party’s Intellectual Property on account of a Third Party’s manufacture, use or sale of a product in the Zomedica Field in the Territory (in each case, a “Product Infringement”), then such Party shall promptly notify the other Party in writing of such Product Infringement, including any evidence in such Party’s possession demonstrating such Product Infringement.
(b) Enforcement. During the Term and subject to the remainder of this Section 8.6(b), Zomedica shall have the first right to initiate, prosecute and control legal proceedings against any person or entity engaged in a Product Infringement, at Zomedica’s expense. If Zomedica decides not to bring such legal action, or if Zomedica fails to initiate such legal action, Celsee shall have the right, but not the obligation, to commence a suit or take action to enforce the applicable Intellectual Property rights with respect to such Product Infringement in the Territory, at its own expense.
(c) Cooperation. Each Party shall provide to the Party enforcing any rights under Section 8.6(b) reasonable assistance in such enforcement, including joining such action as a party plaintiff if required by Applicable Law to pursue such action. The enforcing Party shall keep the other Party reasonably and regularly informed of the status and progress of such enforcement efforts, and shall reasonably consider the other Party’s comments on any such efforts. The non-enforcing Party shall have the right to be represented in any action brought under Section 8.6(b) by counsel of its choice and at its own expense. For clarity, as between the Parties, Celsee shall have the exclusive right to bring and control any legal action in connection with any actual, alleged, or threatened infringement of its Intellectual Property Rights that is not a Product Infringement and is outside the Zomedica Field at its own expense as it reasonably determines appropriate.
(d) Settlement. Without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed, neither Party shall settle any claim, suit or action brought under Section 8.6 involving the Intellectual Property rights of a Party in any manner that (i) admits the invalidity of, or otherwise impairs the other Party’s Intellectual Property or (ii) limits, or would reasonably be expected to limit, the ability of the other Party or its licensees to sell or manufacture Collaboration Products in the Zomedica Field in the Territory or other products outside the Zomedica Field.
(e) Recoveries. Any recoveries resulting from an action brought by a Party under Section 8.6(b) relating to a claim of Product Infringement of an Intellectual Property right hereunder shall be first applied against payment of each Party’s costs and expenses in connection therewith. Any such recoveries in excess of such costs and expenses (the “Remainder”) will be retained by the enforcing Party.
(f) Joint Intellectual Property. If a Third Party infringes any Joint Intellectual Property, the Parties shall discuss such infringement and the Parties shall each have the right, but neither Party shall be obligated, to bring an appropriate suit or other action under such Joint Intellectual Property against any Person engaged in such infringement. If both Parties agree to so enforce such Joint Intellectual Property, they shall be jointly responsible for, and share equally, all the costs and expenses of any suit brought by them and shall equally share all recoveries with respect thereto. If one Party elects not to enforce such Joint Intellectual Property against such infringement, then the other Party shall have the right, but not the obligation, to take action to enforce such Joint Intellectual Property against such infringement at its own cost and expense and such other Party may retain all recoveries with respect thereto.
8.7 Cooperation. Each Party shall reasonably cooperate with the other Party in the Prosecution and Maintenance of the Intellectual Property, including Patent Rights, pursuant to this Agreement. Such cooperation includes promptly executing all documents, or requiring inventors, subcontractors, employees, former employees (to the extent reasonably available) and consultants and agents to execute all documents, as reasonable and appropriate, so as to enable the Prosecution and Maintenance or enforcement of any such Patent Rights in any country.
9.1 Confidentiality; Exceptions. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing or required as a condition of sublicense, the Parties agree that the receiving Party will keep confidential and will not publish or otherwise disclose or use for any purpose other than as provided for in this Agreement any Information furnished to it by the other Party pursuant to this Agreement (collectively, “Confidential Information”). Further, subject to Authorized Disclosures of Section 9.2, each Party shall keep the other Party’s Confidential Information confidential until the information is no longer confidential or an exception below applies. To the extent that Zomedica will be conducting and funding the research pursuant to the Development Plan including the Clinical Validations and Approval, all information generated thereunder shall be the Confidential Information of Zomedica. Notwithstanding the foregoing, Confidential Information will not include any information to the extent that it can be established by written documentation by the receiving Party that such information:
(a) is obtained or was already known by the receiving Party or its Affiliates as a result of disclosure from a Third Party that the receiving Party neither knew nor should have known was under an obligation of confidentiality to the disclosing Party with respect to such information;
(b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party through no act or omission of the receiving Party or its Affiliates in breach of this Agreement;
(c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party or its Affiliates in breach of this Agreement; or
(d) is independently discovered or developed by the receiving Party or its Affiliates (without reference to or use of Confidential Information of the disclosing Party) as demonstrated by the receiving Party’s documented evidence prepared contemporaneously with such independent Development or other equally competent evidence.
9.2 Authorized Disclosure. Except as expressly provided otherwise in this Agreement, each Party may use and disclose Confidential Information of the other Party solely as follows:
(a) Each Party or its Affiliates each may disclose Confidential Information that it has received hereunder to their Affiliates and to those of the personnel and subcontractors of them and their Affiliates who have a need to such information in order to carry out the work under the Development Plan, or allow Zomedica to Develop and commercialize the Collaboration Product(s) and who are themselves under a duty of confidentiality;
(b) under appropriate confidentiality provisions substantially equivalent to those in this Agreement: (i) in connection with the performance of its obligations or as reasonably necessary or useful in the exercise of its rights under this Agreement, and (ii) to the extent it believes such disclosure is reasonably necessary in conducting the activities contemplated under this Agreement;
(c) to the extent such disclosure is to a Governmental Authority as reasonably necessary in filing or prosecuting patent applications in accordance with this Agreement, prosecuting or defending litigation in accordance with this Agreement, complying with applicable governmental regulations with respect to performance under this Agreement, filing regulatory filings, obtaining Regulatory Approval or fulfilling post-approval regulatory obligations for a Collaboration Product, or otherwise required by Law, provided, however, that if a Party is required by Law or the rules of any securities exchange or automated quotation system to make any such disclosure of the other Party’s Confidential Information it will, except where impracticable for necessary disclosures (for example, in the event of medical emergency), give reasonable advance notice to the other Party of such disclosure requirement and, in the case of each of the foregoing, will use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed;
(d) to advisors (including to its directors, managers, members, officers, employees, attorneys, accountants, bankers, financial advisors, subcontractors or consultants) or funding agencies (including that of any Government), to potential investors, financers, licensees/licensors, partners, collaborators, and parties involved in any other business transactions, including any mergers and acquisitions, who themselves would be under a duty of confidentiality or as may otherwise be required under applicable Law including any security laws, under appropriate confidentiality provisions or professional standards of confidentiality substantially equivalent to those of this Agreement; or
(e) to the extent mutually agreed to by the Parties.
9.3 Confidential Treatment of Terms and Conditions. Subject to the exceptions set out in Section 9.2, neither Party shall disclose the terms and conditions of this Agreement except as may be required by Law or as necessary to effect terms of this Agreement.
9.4 Attorney-Client Privilege. Neither Party is waiving, nor will be deemed to have waived or diminished, any of its attorney work product protections, attorney-client privileges or similar protections and privileges as a result of disclosing information pursuant to this Agreement, or any of its Confidential Information (including Confidential Information related to pending or threatened litigation) to the receiving Party, regardless of whether the disclosing Party has asserted, or is or may be entitled to assert, such privileges and protections. The Parties:
(a) share a common legal and commercial interest in such disclosure that is subject to such privileges and protections;
(b) may become joint defendants in proceedings to which the information covered by such protections and privileges relates;
(c) intend that such privileges and protections remain intact should either Party become subject to any actual or threatened proceeding to which the disclosing Party’s Confidential Information covered by such protections and privileges relates; and
(d) intend that after the Effective Date both the receiving Party and the disclosing Party will have the right to assert such protections and privileges.
|10.||Representations, Warranties and Covenants|
10.1 Mutual Representations and Warranties. In addition to the representations and warranties made by a Party elsewhere in this Agreement, each Party hereby represents and warrants to the other Party that:
(a) it is duly organized and validly existing under the Laws of its jurisdiction of organization and it has full corporate power and authority and has taken all corporate action necessary to enter into and perform this Agreement;
(b) It has duly executed and delivered this Agreement and this Agreement is a legal and valid and binding obligation upon such Party and enforceable in accordance with its terms subject only to bankruptcy, insolvency, liquidation, reorganization, moratorium and other similar laws generally affecting the enforcement of creditors’ rights and to the fact that equitable remedies, such as specific performance and injunction, are discretionary remedies;
(c) the execution, delivery and performance of the Agreement by such Party does not (i) conflict with any agreement, instrument or understanding, oral or written, by which it is bound, including its organizational documents (ii) conflict with, violate or constitute a default or require any consent under any contractual obligation or court or administrative order by which such Party is bound or (iii) to its knowledge violate any Law; and the person or persons executing this Agreement on such Party’s behalf have been duly authorized to do so by all requisite corporate action;
(d) it has sufficient legal right and/or beneficial title or ownership of its respective Intellectual Property (including Controlled Technology) to grant the licenses to the other Party as purported to be granted pursuant to this Agreement;
(e) there is no action, litigation or other proceeding in progress, pending or, to its knowledge threatened against it which might result in a material adverse change in its financial condition or which would materially adversely affect its ability to perform its obligations under this Agreement.
(f) All representations and warranties of the Parties will be correct as of the Effective Date and deemed to be continuously given throughout the Term. To the extent a Party becomes aware that any of the representations and warranties are no longer valid as of a date post- the Effective Date, it shall immediately notify the other Party of same.
(g) That as of the Effective Date, the Original Agreement was in full force and effect and that neither Party is aware of any breach or potential breach of the Original Agreement.
10.2 Celsee Representations, Warranties and Covenants. In addition to the representations and warranties made by Celsee above and elsewhere in this Agreement, Celsee hereby represents, warrants, and covenants to Zomedica that:
(a) As of the Effective Date, it has, or will have during the Term of this Agreement, the full right, power and authority to grant to Zomedica the licenses hereunder granted in this Agreement;
(b) As of the Effective Date, there is no suit or legal proceeding pending or threatened in writing with respect to the Background Intellectual Property and it is has no actual knowledge or notice of any infringement of Third Party Intellectual Property by it that would arise in conducting the activities contemplated by this Agreement; All Patents that have issued are valid and enforceable.
(c) As of the Effective Date, Celsee has not entered, and during the Term, will not enter, into any written agreement with a Third Party that conflicts with the rights granted to Zomedica hereunder or Celsee’s ability to fully perform its obligations hereunder;
(d) Celsee has not entered into any written agreement with a Third Party to conduct research with respect to the Celsee Controlled Technology in the Zomedica Field and Celsee is not collaborating with any Third Parties for the Development of Products in the Zomedica Field;
(e) Subject to Section 10.2(d), as of the Effective Date, Celsee has not granted any rights to Third Parties to the Celsee Controlled Technology in the Zomedica Field or the Collaboration Product(s);
(f) Neither Celsee nor any of its Affiliates has been disbarred or is subject to debarment and neither Celsee nor any of its Affiliates shall use in any capacity in connection with the services to be performed under this agreement any person who has been debarred pursuant to Section 306 of the Food Drug and Cosmetic Act (21 U.S.C. 335a) (the “Act”) or who is subject of a conviction described in such section. Celsee agrees to inform Zomedica in writing immediately if any person who is performing services on behalf of Celsee under this Agreement is debarred or is the subject of a conviction described in Section 306 of the Act or if any action, suit, claim, investigation or legal or administrative proceeding or to the knowledge of Celsee is threatened relating to the debarment or conviction of Celsee or any person performing services on behalf of Celsee under this Agreement.
(g) Schedule B accurately lists all Celsee Controlled Patent Rights as of the Effective Date which Schedule shall be updated annually during the Term by Celsee;
(h) That its representatives contributing and conducting activities under this Agreement on behalf of Celsee, including with respect to the Development Plan, all have assigned and have a duty to assign their rights and contributions with respect to any Technology or Intellectual Property developed pursuant to this agreement to Celsee and to no other party;
(i) That it has or will have the ability to and shall manufacture and supply the Collaboration Product(s), the Celsee Platform Technology and the CTC Consumable Packages in accordance with Laws (subject to Zomedica obtaining required regulatory approvals) and volumes forecasted pursuant to this Agreement and has sufficient contingency plans in place to so manufacture and supply.
10.3 Disclaimer of Warranties. EXCEPT AS OTHERWISE SET FORTH IN ARTICLE 10 OF THIS AGREEMENT, THE PARTIES EXPRESSLY DISCLAIM ANY AND ALL REPRESENTATIONS AND WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO THE PATENT RIGHTS, INFORMATION AND ANY OTHER SUBJECT MATTER RELATING TO THIS AGREEMENT, INCLUDING ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OR NONINFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS.
10.4 Disclaimer of Prior Agreements. NOTWITHSTANDING ANYTHING TO THE CONTRARY HEREIN, PARTIES HEREBY ACKNOWLEDGE AND AGREE THAT THEY HAVE FULFILLED ALL OBLIGATIONS, PAYMENTS, AND DUTIES SET FORTH IN THE ORIGINAL AGREEMENT AND CRA. AS OF THE EFFECTIVE DATE, THE PARTIES HEREBY WAIVE, RELEASE, AND FOREVER DISCHARGE THE OTHER PARTY AND ITS OFFICERS, DIRECTORS, INVESTORS, PARTNERS, EMPLOYEES, ALL CLAIMS, AGENTS, LOSSES, AND LIABILITIES, DEBTS, AND EXPENSES (INCLUDNG ATTORNEY'S FEES) OF ANY NATURE WHATSOEVER, KNOWN OR UNKNOWN, SUSPECTED OR UNSUSPECTED, ARISING ON OR PRIOR TO THE DATE OF THIS AGREEMENT EXCEPT FOR WHICH ARISE FROM A PARTY'S GROSS NEGLIGENCE, WILLFUL MISCONDUCT, OR FRAUD.
|11.||Limitations of Liability; Insurance|
11.1 Limitations of Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY, MULTIPLE, CONSEQUENTIAL, OR PUNITIVE DAMAGES OF ANY KIND ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, OR FOR ANY LOSS OR INJURY TO A PARTY’S PROFITS OR GOODWILL, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY (WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR OTHERWISE), EVEN IF SUCH PARTY WAS ADVISED OR OTHERWISE AWARE OF THE LIKELIHOOD OF SUCH DAMAGES, EXCEPT WITH RESPECT TO CONSEQUENTIAL DAMAGES (WHICH IN NO EVENT WILL INCLUDE ANY PUNITIVE DAMAGES) AWARDED TO A PARTY THAT THE NON-BREACHING PARTY DEMONSTRATES RESULTED FROM A BREACH OF SECTION 9.1 (CONFIDENTIALITY; EXCEPTIONS), OR SECTION 9.2 (AUTHORIZED DISCLOSURE). NOTHING IN THIS SECTION 11.1 (LIMITATIONS OF LIABILITY) IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER ARTICLE 12 (INDEMNIFICATION) WITH RESPECT TO ANY DAMAGES PAID BY THE OTHER PARTY TO A THIRD PARTY IN CONNECTION WITH A THIRD PARTY CLAIM.
11.2 Insurance. Each Party shall procure and maintain insurance, including product liability insurance, with respect to its activities hereunder and which are consistent with normal business practices of prudent companies similarly situated at all times during which any Collaboration Product is being clinically tested in animals or commercially distributed or sold. Each Party represents and warrants to the other Party that it has such insurance in effect as of the Effective Date and if requested by the other Party will provide the other Party a copy of the certificate of insurance evidencing such insurance on or prior to the Effective Date. It is understood that such insurance shall not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under Article 12. Each Party shall provide the other with written notice at least thirty (30) days prior to the cancellation, non-renewal or material change in such insurance or self-insurance which materially adversely affects the rights of the other Party hereunder.
12.1 Indemnification by Celsee. Celsee hereby agrees to defend, hold harmless and indemnify (collectively, “Indemnify”) Zomedica and its Affiliates, and its and their directors, officers, employees, contractors and agents (collectively, the “Zomedica Indemnitees”) from and against any liability or expense (including reasonable legal expenses, costs of litigation and attorneys’ fees), damages, or judgments, whether for money or equitable relief (collectively, “Losses”) resulting from suits, proceedings, claims, actions, demands, or threatened claims, actions or demands, in each case brought by a Third Party (each, a “Third Party Claim”) against a Zomedica Indemnitee, including, for each of clauses (a), (b) and (c), below, bodily injury, risk of bodily injury, death (including death of a Companion Animal), property damage, and product liability Third Party Claims or the failure to comply with Law arising out of or relating to, directly or indirectly:
(a) Celsee’s, its Affiliates or subcontractors’ (collectively, the “Celsee Parties”) activities, including Development activities, under the Development Plan and the manufacture, supply, transfer, labeling, handling or storage of the Collaboration Product;
(b) the Celsee Parties’ negligence, recklessness, intentional misconduct or intentional acts or omissions; provided that the foregoing shall not apply to any action or omission undertaken at the direction or request of any Zomedica Indemnitee outside of the Development Plan; or
(c) Celsee’s material breach of any duty, representation, warranty, obligation or covenant set out in this Agreement;
(d) Celsee’s failure to supply Collaboration Product in accordance with forecasted volumes agreed to by the parties;
(e) Celsee’s obligation to Indemnify the Zomedica Indemnitees pursuant to this Section 12.1 shall not apply to the extent that any such Losses (i) arise from the acts or omissions of any Zomedica Indemnitee; (ii) arise from any material breach by Zomedica of this Agreement; or (iii) arising out of Zomedica’s activities under the Development Plan.
12.2 Indemnification by Zomedica. Zomedica hereby agrees to Indemnify Celsee and its Affiliates, and its and their directors, officers, employees, contractors and agents (the “Celsee Indemnitees”) from and against any and all Losses resulting from Third Party Claims, including, for each of clauses (a), (b) and (c), below, bodily injury, risk of bodily injury, death, property damage, and product liability Third Party Claims or the failure to comply with Law arising out of or relating to, directly or indirectly:
(a) Zomedica’s, its Affiliates’, sublicensees’, wholesalers’, distributors’ or sub-contractors’ (collectively, the “Zomedica Parties”) activities (including Development) under the Development Plan, use, Development, commercialization, transfer, labeling, handling or storage, promotion, marketing, distribution, offer for sale, sale, import or export of any Collaboration Product in the Territory;
(b) the Zomedica Parties’ negligence, recklessness, intentional misconduct or intentional acts or omissions; provided that the foregoing shall not apply to any action or omission undertaken at the direction or request of any Celsee Indemnitee outside of the Development Plan; or
(c) Zomedica’s material breach of any duty, representation, warranty or covenant set out in this Agreement.
(d) Zomedica’s obligation to Indemnify the Celsee Indemnitees pursuant to the foregoing sentence shall not apply to the extent that any such Losses (i) arise from the acts or omissions of any Celsee Indemnitee; (ii) arise from any material breach by Celsee of this Agreement; or (iii) arising out of Celsee’s activities under the Development Plan.
12.3 Claim for Indemnification. Whenever any Claim or Loss arises for which a Zomedica Indemnitee or a Celsee Indemnitee (the “Indemnified Party”) may seek indemnification under this Article 12 (Indemnification), the Indemnified Party will promptly notify the other Party (the “Indemnifying Party”) of the Claim or Loss and, when known, the facts constituting the basis for the Claim or Loss; provided, however, that the failure by an Indemnified Party to give such notice or to otherwise meet its obligations under this Section 12.3 (Claim for Indemnification) does not relieve the Indemnifying Party of its indemnification obligation under this Agreement except and only to the extent that the Indemnifying Party is actually prejudiced as a result of such failure. The Indemnifying Party has exclusive control of the defense and settlement of all Claims for which it is responsible for indemnification and shall assume the defense thereof at its own
expense promptly upon notice of such Claim or Loss. The Indemnified Party shall not settle or compromise any Claim by a Third Party for which it is entitled to indemnification without the prior written consent of the Indemnifying Party, unless the Indemnifying Party is in breach of its obligation to defend hereunder. In no event can the Indemnifying Party settle any Claim without the prior written consent of the Indemnified Party if such settlement does not include a complete release from liability on such Claim or if such settlement would involve undertaking an obligation other than the payment of money, would bind or impair the Indemnified Party, or includes any admission of wrongdoing or that any intellectual property or proprietary right of the Indemnified Party is invalid or unenforceable. The Indemnified Party shall reasonably cooperate with the Indemnifying Party at the Indemnifying Party’s expense and shall make available to the Indemnifying Party reasonably requested information under the control of the Indemnified Party, which information is subject to Article 9 (Confidentiality). The Indemnifying Party shall permit the Indemnified Party to participate in (but not to control) the Third Party Claim through counsel of its choosing (to the extent it has the ability to do so). Notwithstanding any other provision of this subsection, if an Indemnified Party withholds consent to a bona fide settlement offer, where but for such action, the Indemnifying Party could have settled such Claim, the Indemnifying Party shall be required to indemnify the Indemnified Party only up to a maximum of the bona fide settlement offer for which the Indemnifying Party could have settled such Claim.
12.4 Limitation of Indemnification. Celsee’s liability for indemnification pursuant to Section 12.1, and Zomedica’s liability for indemnification pursuant to Section 12.2 herein, shall be limited in total and in the aggregate to an amount equal to [*].
|13.||Term and Termination|
13.1 Term. This Agreement shall commence as of the Effective Date and, unless sooner terminated in accordance with the terms hereof shall extend for five (5) years (the “Initial Term”) and automatically renewal for additional two-year terms (such time period collectively referred to as the “Term”) unless (i) either Party within two years prior to the expiration of the then current term provides written notice of its intent not to renew or (ii) the Agreement is terminated pursuant to Sections 13.2 or 13.3 below.
13.2 Termination by both Parties.
(a) Either Party may terminate this Agreement upon written notice to the other Party:
(i) Material Breach. By the non-breaching party in the event of any material breach by a Party of this Agreement; provided that the non-breaching Party provides notice of such breach to the other Party specifying the nature of the alleged breach and such breach has not been cured by the breaching Party within thirty (30) days after such notice thereof; and/or
(ii) Mutual Consent. By mutual written consent of the Parties.
13.3 Termination for Insolvency or Bankruptcy.
(a) Insolvency Event; Definition. Either Party may terminate this Agreement in its entirety upon providing written notice to the other Party on or after the time that such other Party makes a general assignment for the benefit of creditors, files an insolvency petition in bankruptcy or makes a voluntary assignment in bankruptcy, petitions, applies for or acquiesces to the appointment of any receiver, receiver and manager, interim receiver, trustee or similar officer or official to liquidate or conserve its business or any substantial part of its assets, commences under the laws of any jurisdiction any proceeding involving its insolvency, bankruptcy, reorganization, adjustment of debt, dissolution, liquidation or any other similar proceeding for the release of or other relief for financially distressed debtors, or becomes a party to any proceeding or action of the type described above and not dismissed within ninety (90) days of filing or released within ninety (90) days of the event(each, an “Insolvency Event”).
(b) Bankruptcy Laws.
(i) All rights and licenses granted to Zomedica under or pursuant to this Agreement, including, for the avoidance of doubt, the licenses granted to Zomedica pursuant to this Agreement, are, and shall otherwise be deemed to be, for purposes of Section 32(6) of the Companies’ Creditors Arrangement Act (Canada) (“CCAA”), Section 65.11(7) of the Bankruptcy and Insolvency Act (Canada) (“BIA”) or for purposes of Section 365(n) of the U.S. Bankruptcy Code, if applicable, and other similar laws in any jurisdiction outside of Canada (collectively, the “Bankruptcy Laws”), licenses of rights to “intellectual property” as contemplated under the Bankruptcy Laws including, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code.
(ii) Upon the occurrence of any Insolvency Event with respect to Celsee (the “Insolvent Party”), Celsee agrees that Zomedica, as licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Laws.
(iii) Further, it is the intention of the Parties that if either party becomes insolvent, the other party shall have an exclusive option, exercisable upon written notice to the other party, to negotiate a paid-up license to any intellectual property necessary to independently continue commercialization of the Collaboration Product(s), including the Celsee CTC Platform Technology and Celsee Immunochemistry Consumable Package(s) in the Zomedica Field.
(iv) Further, each Party agrees and acknowledges that all payments hereunder, other than the milestone payments pursuant to Section 7.1 do not constitute “obligations owing under the agreement in relation to the use of the intellectual property” as contemplated by Section 32(6) of the CCAA or Section 65.11(7) of the BIA or 365 (n)(2)(B) of the US Bankruptcy Code or relate to licenses of intellectual property hereunder.
(v) Each Party shall, during the term of this Agreement, create and maintain current copies or, if not amenable to copying, detailed descriptions or other appropriate embodiments, to the extent feasible, of all such intellectual property.
(vi) Each Party agrees and acknowledges that “intellectual property” as contemplated by the Bankruptcy Laws include laboratory notebooks, cell lines, product samples and inventory, research studies and data, regulatory approvals and regulatory materials in each case to the extent related to the Collaboration Products.
(vii) It is the intention of the parties that if:
(A) a case or proceeding is commenced during the Term by or against Celsee under the Bankruptcy Laws;
(B) this Agreement is disclaimed as provided for under the Bankruptcy Laws; and
(C) Zomedica elects to retain its rights hereunder as provided for under the Bankruptcy Laws or otherwise,
then Celsee (in any capacity) and its successors and assigns (including a receiver, interim receiver or trustee in bankruptcy and any assignee thereof of any right or power of attorney that Celsee may have or may exercise under, or in connection with, this Agreement), shall (i) provide to Zomedica immediately upon Zomedica’s written request copies of all such intellectual property (including embodiments thereof) held by Celsee and such successors and assigns, or otherwise available to them, and (ii) not interfere with Zomedica’s rights under this Agreement, or any related agreements between the Parties, to such intellectual property (including such embodiments), including any right to obtain such intellectual property (or such embodiments) from another entity.
(viii) Whenever Celsee or any of its successors or assigns provides to Zomedica any of the intellectual property licensed hereunder (or any embodiment thereof) pursuant to this Section 13.3, Zomedica shall have the right to perform Celsee’s obligations hereunder with respect to such intellectual property, but neither such provision nor such performance by Zomedica shall release Celsee from liability resulting from disclaimer of the license or the failure to perform such obligations.
(ix) All rights, powers and remedies of Zomedica as provided herein are in addition to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at law or in equity (including the Bankruptcy Laws) in the event of the commencement of a case or proceeding by or against Celsee under the Bankruptcy Laws.
(x) In particular, it is the intention and understanding of the Parties that the rights granted to Zomedica under this Section 13.3 are essential to the Parties’ respective businesses and the Parties acknowledge that damages are not an adequate remedy.
(xi) The Parties agree that they intend the following rights to extend to the maximum extent permitted by applicable Law, and to be enforceable under Section 32(6) of the CCAA and Section 65.11(7) of the BIA and the relevant provisions of the US Bankruptcy Code:
(A) the right of access to any intellectual property (including embodiments thereof) of Celsee, or any Third Party with whom Celsee contracts to perform an obligation of Celsee under this Agreement, and, in the case of the Third Party, which is necessary for the exploitation of Collaboration Products;
(B) the right to contract directly with any Third Party to complete the contracted work upon failure of Celsee to comply with its applicable obligations; and
(C) in favor of Zomedica, the right to the benefit of the exercise of any power of attorney held by Celsee to grant to Zomedica the rights and licenses provided in this Agreement.
(xii) Further, it is the intention of the Parties that this Agreement, even if not disclaimed, be binding on any party that purchases the intellectual property licensed to Zomedica, or any power of attorney that permits such license to Zomedica, pursuant to any Bankruptcy Laws, notwithstanding any approval and vesting order that may be issued in respect of such intellectual property or power and that Zomedica receive reasonable prior notice of any motion brought pursuant to any Bankruptcy Laws to approve such sale. For greater certainty, nothing herein shall be construed as a waiver of any right that Zomedica may have to object to such sale, including on the basis that such sale of intellectual property or power is contrary to the terms of this Agreement.
13.4 Effect of Termination or Expiration.
(a) Prior to Clinical Validation. Prior to Clinical Validation, upon the effective date of termination or expiration of the Term, except as otherwise expressly provided herein, all rights and obligations of each Party with respect to the whole Agreement or to those Collaboration Products which are the subject of the termination shall cease, including all rights and licenses granted by a Party to the other Party with respect to same. Each Party shall return to the other their respective Confidential Information and Controlled Intellectual Property and Materials (provided that each Party may keep one copy of such Confidential Information for archival purposes only).
(b) The Parties shall use Commercially Reasonable Efforts and cooperate to diligently wind down, according to good clinical and industry practice, any clinical trials that are ongoing for Collaboration Product(s) in the Territory at the time of notice of such termination and to assure a smooth termination transition with respect to the Collaboration Product trials being conducted by or on behalf of Zomedica (or its Affiliate or sublicensee) at the time of notice of
termination which Zomedica determines to continue in compliance with the Laws and ethical guidelines applicable to the transfer or termination of such studies and commercial activities, if any, provided that nothing herein shall require Zomedica to undertake any new Development, manufacture or commercialization or other activities.
(c) Upon termination of this Agreement, the parties shall pay each other the entire amount of any financial commitments incurred by a Party prior to termination even if those financial commitments come due after termination in accordance with the Development Plan Budget that exceed amounts paid by the owing party to the other party hereunder prior to such termination and cannot be canceled; except that the owing party shall only be responsible for paying [*]. Upon receipt of notice of termination, to the extent possible, the parties shall promptly terminate any outstanding commitments and avoid incurring any further costs under the Development Plan. No later than [*] after the effective date of termination or expiration of the Term, unless another period is agreed to in writing by the Parties, the Party may provide an invoice to the other Party in respect of the final payment due and payable. The owing Party shall pay all such amounts no later than [*] after receipt of such invoice. Notwithstanding the foregoing, it is understood that, in no event shall the funds payable exceed the maximum amount set forth in the Development Plan Budget or any supply order. In addition, within [*] after such effective date of termination each Party shall provide the other with a final accounting for all Development Plan Budget and supply orders. Should the final accounting indicate an amount is due to a Party, such final payment will be made in accordance with Section 7.1. If the final accounting indicates an overpayment the party which received the overpayment shall refund such overpayment to the other Party within [*] of the final accounting.
(d) Accrued Rights. Expiration or termination of this Agreement (or any provision hereof) for any reason is without prejudice to any right that shall have accrued to the benefit of a Party prior to such expiration or termination, including damages arising from any breach under this Agreement. Expiration or termination of this Agreement does not relieve a Party from any obligation that is expressly indicated to survive such expiration or termination.
13.5 Non-Exclusive Distribution Rights for the Post-Term Period.
(a) Notwithstanding anything to the contrary, in the event of any expiration or termination of this Agreement, other than termination by Celsee for Zomedica’s uncured material breach under Section 13.2 (a)(i), termination by mutual agreement under 13,2 (a)(ii) or termination prior to Clinical Validation under 13.4(a), and provided that Zomedica has made all required payments under Section 7.1 and has issued all stock to be issued under Section 7.2: (A) Zomedica may continue to distribute, market and promote sales of the CTC Consumable Package for use in the Zomedica Field in the Territory on a non-exclusive basis for a period of [*] from the effective date of such expiration or termination (the “Post Term Period”), and (B) Celsee will continue to supply the CTC Consumable Package products to Zomedica during the Post Term Period at the pricing set forth in this Agreement; in each case, subject to the terms and conditions of this Section
13.5. Notwithstanding the foregoing, if Zomedica fails to purchase CTC Consumable Package Products during the Post Term Period for [*], all licenses and rights to purchase CTC Consumable Package Products during the Post Term Period shall immediately terminate. Subject to the foregoing, all provisions of this Agreement will continue to apply during the Post Term Period, with the following exceptions:
(i) the license granted to Zomedica pursuant to Section 6.2 shall automatically convert to non-exclusive during the Post Term Period;
(ii) Section 2.1 (“Exclusivity”) shall not apply during the Post Term Period;
(iii) the rights granted to Zomedica pursuant to Section 4.2(a) (“Manufacturing and Product Supply”) shall automatically convert to non-exclusive during the Post Term Period;
(iv) Section 13.3(b) (“Bankruptcy License Option”) shall not apply during the Post Term Period.
13.6 Survival. The following provisions shall survive termination or expiration of this Agreement: Sections 7, 8, 9, 10, 11, 12, 13.4,, 14 and 15 and Section 1 to the extent necessary to give effect to the foregoing. In addition, except as provided in Section 13.5, all other provisions of this Agreement shall survive the expiration or termination of this Agreement until the end of the Post Term Period.
14.1 Discussion by Senior Executives. If there is an unresolved matter, dispute or issue arising out of or relating to the existence, negotiation, validity, formation, interpretation, breach, performance or application of this Agreement (each, a “Dispute”) for which neither Party has the final decision making authority as expressly provided elsewhere in this Agreement, either Party will refer such Dispute to their respective Presidents (such persons, the “Senior Executives”), or their designee(s), in writing for further discussion and resolution. These individuals shall as soon as practicable meet and attempt in good faith to resolve the Dispute and reach agreement. These individuals may obtain the advice of other employees or consultants as they deem necessary or advisable in order to make the decision. If these individuals cannot reach agreement as to the Dispute within thirty (30) days of the Dispute being referred to them, then such Dispute will be resolved as set out in this Article 14.
14.2 Mediation and Arbitration. If the Senior Executives are not able to resolve such Dispute referred to them under Section 14.1 within thirty (30) days, the Parties shall first refer such Dispute to proceedings under the International Chamber of Commerce (“ICC”) Mediation Rules. If the dispute has not been settled pursuant to the said Rules within forty-five (45) days following the filing of a Request for Mediation or within such other period as the parties may agree in writing, such dispute shall thereafter be finally settled under the Rules of Arbitration of the International Chamber of Commerce by one or more arbitrators appointed in accordance with the said Rules of Arbitration. Except to the extent necessary to confirm an award or as may be required by law, neither Party nor any arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of both parties.
14.3 Patent Dispute Resolution. Any Dispute relating to the ownership, scope, validity, enforceability or infringement of any Patent Rights shall be submitted to a court of competent jurisdiction in which such Patent Rights exist.
14.4 Payment Dispute Resolution. Notwithstanding the provisions of Section 14.2, any dispute, controversy or claim relating to a payment made pursuant to this Agreement shall be submitted for resolution to a member (the “Arbitrator”) of an accounting firm of national standing selected by both Parties (and which shall not be the auditor of either of the Parties) within thirty (30) days after notice of the dispute is received or deemed to be received by a Party. If the Parties cannot agree on an Arbitrator, the provisions of Section 14.2 shall apply. The Parties shall make submissions to the Arbitrator within ninety (90) days after the selection of the Arbitrator and the Arbitrator will select one Party’s submission. If the Parties cannot agree on a member of the accounting firm, the provisions of Section 14.2 shall apply. The decision of the Arbitrator in selecting on Party’s submission shall be final and binding on both Parties.
14.5 Waiver. EACH PARTY HERETO (1) WAIVES ITS RIGHT TO TRIAL UNDER ANY ISSUE BY JURY WITH RESPECT TO ANY DISPUTE BROUGHT UNDER THIS AGREEMENT, (2) WITH THE EXCEPTION OF RELIEF MANDATED BY STATUTE, ANY CLAIM TO PUNITIVE, EXEMPLARY, MULTIPLIED, INDIRECT, CONSEQUENTIAL OR LOST PROFITS/REVENUES DAMAGES, AND (3) ANY CLAIM FOR ATTORNEY FEES, COSTS AND PREJUDGMENT INTEREST.
15.1 Affiliates and Designees. Each Party has the right to exercise their respective rights, perform their respective obligations and/or receive performance of the other Party’s obligations hereunder through their Affiliates or sublicensees.
(a) Neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred (whether by operation of Law, general succession or otherwise) by either Party without the prior written consent of the other Party, said consent not to be unreasonably withheld.
(b) The above notwithstanding, either party may, without the other party’s consent, assign such rights: (i) to an Affiliate; (ii) in connection with the transfer or sale of all or substantially all of the business of such Party to which the Agreement relates to a third party, whether by merger, sale of stock, sale of assets or otherwise; and (iii) in connection with a Change of Control.
(c) The rights and obligations of the parties under this Agreement shall be binding upon and enures to the benefit of the Parties and their respective successors and permitted assigns. The Parties shall promptly notify the other Party of any transfer under said Section 15.2 or any Change of Control.
15.3 Counterparts. This Agreement may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts will be deemed an original, will be construed together and will constitute one and the same instrument. Signature pages of this Agreement may be exchanged by facsimile or other electronic means without affecting the validity thereof.
15.4 No Contra Proferentem. This Agreement has been reviewed by each Party’s professional advisors, and revised during the course of negotiations between the Parties. Each Party acknowledges that this Agreement is the product of their joint efforts, that it expresses their agreement, and that, if there is any ambiguity in any of its provisions, no rule of interpretation favoring one Party over another based on authorship will apply.
15.5 Entire Agreement. This Agreement, including the attached Schedules constitutes the entire agreement between the Parties as to the subject matter of this Agreement, and supersedes and merges all prior discussions, representations, agreements including the Original Agreement and understandings regarding the same.
15.6 Time is of the Essence. Time is of the essence in all respects of this Agreement.
15.7 Force Majeure. Neither Party is liable for a delay or failure in the performance of any of its obligations hereunder (other than the payment of money) if such delay or failure is due to causes beyond its reasonable control, including acts of God, fires, floods, earthquakes, labor strikes, acts of war, terrorism or civil unrest (“Force Majeure”); provided, however, that the affected Party notifies the other Party in writing within thirty (30) days of the Force Majeure event (and continues to provide monthly status updates to the other Party for the duration of the effect); further provided that the affected Party will use its reasonable efforts to avoid or remove such causes of non-performance and to mitigate the effect of such occurrence, and will continue performance with reasonable dispatch whenever such causes are removed.
15.8 Further Assurances. Each Party agrees to do and perform all such further acts and things and will execute and deliver such other agreements, certificates, instruments and documents necessary or that the other Party may reasonably request in order to carry out the intent and accomplish the purposes of this Agreement and to evidence, perfect or otherwise confirm its rights hereunder.
15.9 Headings. Headings and captions are for convenience only and are not to be used in the interpretation of this Agreement.
15.10 Notices. Any notice required or permitted to be given by this Agreement will be in writing, in English, and will be delivered by hand or overnight courier with tracking capabilities or transmitted by confirmed facsimile, charges (if any) prepaid and addressed as set forth below unless changed by notice so given:
|If to CELSEE:||Celsee, Inc.|
100 Phoenix Drive, Suite 321
Ann Arbor, MI 48108
Attn: John Stark
Title: President & CEO
|If to Zomedica:||100 Phoenix Drive, Suite 190|
|Ann Arbor, MI 48108|
|Attn: Shameze Rampertab|
|Title: Interim CEO and CFO|
Any such notice will be deemed given or made and received on the date delivered provided that if that day is not a Business Day then the notice will be deemed to have been given or made and received on the next Business Day. A Party may add, delete (so long as at least one person is remaining), or change the person or address to which notices should be sent at any time upon written notice delivered to the other Party in accordance with this Section 15.10 (Notices).
15.11 Relationship of the Parties. Each Party is an independent contractor under this Agreement. Nothing contained herein is intended or is to be construed so as to constitute Zomedica and Celsee as partners, agents or joint venturers. Neither Party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any Third Party.
15.12 Severability. If any one or more of the provisions of this Agreement is held to be invalid or unenforceable, the provision will be considered severed from this Agreement and will not serve to invalidate any remaining provisions hereof. The Parties will negotiate in good faith to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.
15.13 Third Party Beneficiaries. Except as expressly provided with respect to Celsee Indemnitees or Zomedica Indemnitees in Article 12 (Indemnification) (for whom Celsee and Zomedica, respectively, hold such rights in trust), there are no third-party beneficiaries intended hereunder and no Third Party will have any right or obligation hereunder.
15.14 Waivers and Modifications. The failure of any Party to insist on the performance of any obligation hereunder is not be deemed to be a waiver of such obligation. Waiver of any breach of any provision hereof is not be deemed to be a waiver of any other breach of such provision or any other provision on such occasion or any other occasion. No waiver, modification, release or amendment of any right or obligation under or provision of this Agreement will be valid or effective unless in writing and signed by all Parties hereto.
15.15 Vienna Convention. The United Nations Convention on Contracts for the International Sale of Goods (also called the Vienna Convention) will not be applicable to this Agreement or the transactions contemplated by this Agreement.
15.16 Governing Law. This Agreement and any dispute hereunder will be governed by the laws of the state of Delaware and the federal laws of the United States of America applicable therein. Subject to the provisions of Section 14, the Parties attorn to the non-exclusive jurisdiction of the courts of Michigan.
THE REMAINDER OF THIS PAGE IS INTENTIONALLY LEFT BLANK
IN WITNESS WHEREOF, the Parties have executed this Agreement by proper persons thereunto duly authorized as of the Effective Date set forth above.
|CELSEE, Inc.||Zomedica Pharmaceuticals Corp.|
|By:||/s/ John Stark||By:||/s/ Shameze Rampertab|
|Title:||Chief Executive Officer||Title:||Interim Chief Executive Officer and Chief Financial Officer|
|Date:||January 17, 2020||Date:||January 17, 2020|
CELSEE PATENT RIGHTS
COMPLIANCE SCHEDULE AND CODE OF CONDUCT
Compliance with Laws including FCPA/CFPOA and HIPAA/PIPEDA
|1.1.||Each Party acknowledges that the other Party aims to perform its activities, and to have parties who enter into business arrangements with them to perform their activities under such arrangements, in accordance with the highest ethical standards and best industry practices, including without limitation any voluntary codes of practice applicable in the industry for the research. Each Party agrees to use commercially reasonable efforts to help ensure that the other Party does not fail to meet such aim with respect to activities hereunder through any violation of the Canadian Corruption of Foreign Public Officials Act (the “CFPOA”) or the U.S. Foreign Corrupt Practices Act (the “FCPA”), as applicable.|
|1.2.||Each Party shall comply with all applicable Laws concerning its efforts in any country or jurisdiction where it is providing work hereunder or otherwise applying to any of its activities under this Agreement. Neither party shall perform any actions that are prohibited by local and other anti-corruption laws, including the CFPOA or the FCPA (collectively “Anti-Corruption Laws”) that may be applicable to one or both parties to the Agreement. Without limiting the foregoing, neither party shall make any payments, or offer or transfer anything of value, to any government official or government employee, to any political party official or candidate for political office or to any other third party related to the transaction in a manner that would violate Anti-Corruption Laws.|
|1.3.||Health Care Professionals Engaged on Behalf of Each Party. “Health Care Professional” or "HCP" is defined as (i) any person who is licensed by a province or state to provide health care services directly or indirectly to patients, such as a physician, a nurse, a technician, a psychologist, or a lab specialist and/or (ii) any person or organization to whom Zomedica markets its products and services that is in a position to influence the selection of the products furnished or purchased, including but not limited to hospitals and health systems, administrators, procurement personnel, group purchasing organizations, pharmacy benefit managers, and business people. In the case of use of animals, Health Care Professional includes and Veterinarian assistants and technicians.|
|1.4.||Compliance Obligations Related to Engagement of Health Care Professionals. If applicable, the Parties shall, with respect to each HCP engaged under this Agreement or the Development Plan:|
a. ensure that the HCP’s services are provided in compliance with all applicable laws and regulations, including but not limited to: Laws pertaining to the promotion of products regulated by (i) the Health Canada or the United States Food and Drug Administration (FDA), (ii) the Canadian Competition Bureau or the U.S. Federal Trade Commission, and (iii) other state, provincial or federal regulatory agencies; laws, regulations and guidance pertaining to federal, provincial and state anti-kickback and submission of false claims to governmental or private health care payors, or (iv) applicable analogous or corresponding laws of the applicable jurisdiction (collectively, “Health Care Compliance” or “HCC”); provincial, state and federal laws and regulations relating to the protection of individual and patient privacy; and any other laws and regulations applicable to such services;
b. ensure that HCP’s services are provided in compliance with each Party’s written policies and procedures of which the other Party is provided notice, including, but not limited to, applicable policies and procedures related to the U.S. FDA and Health Care Compliance, Health Canada, the Canadian Food and Drugs Act and Regulations, the Canadian Personal Information Protection and Electronic Documents Act (“PIPEDA”), substantially similar provincial legislation and the protection of individual and patient privacy;
c. ensure that each HCP is:
(i) not excluded from a U.S. Federal health care program as outlined in Sections 1128 and 1156 of the Social Security Act (see the Office of Inspector General of the Department of Health and Human Services List of Excluded Individuals/Entities at http://www.oig.hhs.gov/FRAUD/exclusions/listofexcluded.html) or any Canadian health care or animal care programs;
(ii) not debarred by the U.S. FDA under 21 U.S.C. 335a (see the FDA Office of Regulatory Affairs Debarment List at http://www.fda.gov/ora/compliance_ref/debar/);
(iii) not otherwise excluded from contracting with the U.S. federal government (see the Excluded Parties Listing System at http://epls.arnet.gov) to the extent that foreign entities are not restricted from contracting with the U.S. federal government or the Canadian federal or provincial governments; and
(iv) for HCPs (including veterinarians) who are health care practitioners, duly licensed in the state or province where he or she is currently practicing and not on probation and have never been on probation with the agency or board or college responsible for his or her licensure;
d. ensure that each HCP is qualified and authorized to perform the services as may be agreed to by Celsee and Zomedica in the Development Plan, or required by Law or any applicable authority, including, but not limited to, any required ethics or other authorizations from federal, state, provincial or local government agencies for HCPs who are employees of such agencies. Also, Each Party shall ensure that each HCP is not limited in providing these services by any obligation to third parties; and
e. compensate each HCP the fair market value for his/her services, based on the services provided, and in a manner that does not take into account the volume or value of any prescriptions, referrals or business generated among the parties.
|1.5||Promotion of Zomedica’s products. Celsee shall not make any representation relating to Zomedica’s products or to Zomedica’s clinical (animal) outcomes, unless such representations have been reviewed and approved in advance by Zomedica. Celsee further agrees that, in the event that Celsee fails to observe any limitations imposed by the Zomedica on such product representations or representations concerning clinical outcomes, Zomedica shall have the right to immediately terminate this Agreement.|
|1.6||Protected Health Information under the Canadian PIPEDA, substantially similar provincial legislation such as the Ontario Personal Health Information Protection Act, 2004 and the U.S. HIPAA. If applicable, in the event that the Development Plan requires the use or disclosure of Personal Health Information or Protected Health Information (as defined under PIPEDA, substantially similar provincial legislation or the U.S. HIPAA Privacy Requirements or analogous legislation of the applicable jurisdiction) by HCPs, each Party shall ensure that the program complies with any applicable privacy laws, including as applicable the PIPEDA (and substantially similar provincial legislation, such as the Ontario Personal Health Information Protection Act, 2004) and HIPAA Privacy Requirements that apply to such Personal Health Information or Protected Health Information. The “HIPAA Privacy Requirements” refer collectively to the applicable provisions of the Administrative Simplification section of HIPAA - the Health Insurance Portability and Accountability Act of 1996, (as codified at 42 U.S.C. § 1320d - d-8) and any regulations promulgated there under, including without limitation, the federal privacy regulations (45 CFR Parts 160 and 164) and the federal security standards (45 CFR Part 142).|
|1.7||Consent to Use and Disclose Information. If applicable, in the event that the Development Plan requires direct interactions with patients, consumers or caregivers, each Party shall obtain written consent from any such person providing each Party the right to use and disclose the information collected from such persons, as set forth in the Development Plan. To the extent that the Development Plan or activities requires testing or application to animals, then the Parties shall comply with the applicable Laws and highest ethical standards governing animal testing and welfare, such as in the United States, the Animal Welfare Act of 1966 (“AWA”), and the Animal Welfare Regulations and provide for an Institutional Animal Care and Use Committee (“IACUC”).|
CUSTOMER SERVICE REQUIREMENTS