FORM OF Transition, Services and Resupply Agreement by and among AS Kevelt, OJSC Pharmsynthez and Xenetic Biosciences, Inc.
Exhibit 10.11
FORM OF
Transition, Services and Resupply Agreement
# 15-8-311
by and among
AS Kevelt,
OJSC Pharmsynthez
and
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Transition and Resupply Agreement
This Transition, Services and Resupply Agreement (the “Transition and Resupply Agreement”), dated as of October __, 2015 (“Effective Date”) is entered into among AS Kevelt, an Estonian pharmaceutical company (“Kevelt”), OJSC Pharmsynthez, a Russian pharmaceutical company and parent of Kevelt (“Pharmsynthez”) and Xenetic Biosciences, Inc., a Nevada corporation (“Xenetic”).
Article I.
Any capitalized terms not defined in this Transition and Resupply Agreement shall have the meaning given such term(s) in the Agreement. Any references in this Transition and Resupply Agreement to “Articles” and/or “Sections” shall refer to Articles and/or Sections of this Transition and Resupply Agreement, unless specified to be referring to Articles and/or Sections of the Agreement. For purposes of this Transition and Resupply Agreement, the following capitalized terms, whether used in the singular or plural, shall have the following meanings:
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Section 1.01 “Kevelt/Pharmsynthez Manufacturing Know-How” means Virexxa batch formula and production related data, methods, processes, standard operating procedures (“SOP”), and relevant proprietary information together with all applicable improvements, that are owned by Kevelt and Pharmsynthez or their Affiliates.
Section 1.02 “Kevelt/Pharmsynthez Patents” means the Patents Owned by Kevelt and/or Pharmsynthez and their Affiliates as of the Effective Date having one or more valid and unexpired claims (i) that cover Virexxa; or (ii) that cover processes directed to formulating and manufacturing Virexxa. For purposes of this Transition andResupply Agreement, the phrase “valid and unexpired claim” shall mean a composition of matter, method of use or method of manufacture claim (or equivalent thereof) of an issued and unexpired Patent, or a composition of matter, method of use or method of manufacture claim (or equivalent thereof) of a pending application, which (i) has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time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.
Section 1.03 “Deliver” or “Delivery,” with respect to Virexxa means, and shall take place upon, the transfer of possession of Virexxa to a Xenetic EXW (Incoterms 2010) at the place the Virexxa will be shipped to Xenetic.
Section 1.04 “Excluded Uses” shall mean the use of Virexxa in the Retained Territory for the treatment of all diseases included in Exhibit A (Indications for Excluded Uses).
Section 1.05 “Permitted Uses” shall mean the use of Virexxa and the Intellectual Property for the treatment of all diseases and conditions other than the Excluded Uses. Permitted Uses shall include but not be limited to the treatment of cancer indications and the use of the Intellectual Property as an immune modulator or in association with interferon.
Section 1.06 “Specification(s)” means the requirements, standards, quality control testing and other attributes pertaining to Virexxa, as set forth in a specification that shall be agreed upon by the Parties following the entry of the Parties into this Transition and Resupply Agreement and as approved by the appropriate governmental agencies and bodies.
Section 1.09 “Virexxa” shall mean medicinal product Sodium Cridanimod (Virexxa®) (Oxodihydroacridinylacetate sodium containing a Sodium 2-(9-oxoacridin-10-yl) acetate, any derivatives, isomers, substitutions or any other form, as an active pharmaceutical ingredient, developed by Kevelt and/or Pharmsynthez and having properties described in the Chemical, Manufacturing and Controls (“CMC”) and medicinal product dossier (“MPD”) for the Permitted Uses.
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Article
II.
Manufacture and Supply, Technology Transfer and Transition
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Section 2.03 Replacement of Defective Item. IN ACCORDANCE WITH THE TERMS SET FORTH IN THIS TRANSITION AND RESUPPLY AGREEMENT, KEVELT AND/OR PHARMSYNTHEZ SHALL REPLACE, AT ITS SOLE EXPENSE, ALL ITEMS THAT DO NOT COMPLY OR ARE FOUND NOT TO COMPLY WITH THE SPECIFICATIONS (“DEFECTIVE ITEM”), OR SHALL CREDIT XENETIC FOR AMOUNTS ALREADY PAID FOR THE DEFECTIVE ITEM. THE OBLIGATION OF KEVELT AND/OR PHARMSYNTHEZ TO REPLACE DEFECTIVE ITEMS IN ACCORDANCE WITH THE SPECIFICATIONS OR PROVIDE CREDIT SHALL BE XENETIC’S SOLE AND EXCLUSIVE REMEDY UNDER THIS TRANSITION AND RESUPPLY AGREEMENT FOR DEFECTIVE ITEMS, AND IS IN LIEU OF ANY OTHER REMEDY, EXPRESS OR IMPLIED.
Section 2.05 Manufacture of Virexxa.
(a) Manufacture. With respect to Virexxa, from the Effective Date, Kevelt and Pharmsynthez will be responsible for supplying Xenetic with Virexxa under the following terms and conditions:
(i) Forecasting. In accordance with Section 2.01, Virexxa shall be supplied by Kevelt and/or Pharmsynthez to Xeneticin an amount that does not exceed 5,000 ampoules of Virexxa per month. On or before the first day of each calendar month, Xenetic shall furnish to Kevelt and/or Pharmsynthez a written six (6) month rolling forecast of the quantity of Virexxa that Xenetic estimates it will order from Kevelt and/or Pharmsynthez during such six (6) month forecast period (the “Forecast”; the first of which is attached hereto as Schedule 1). The first three (3) months of each Forecast shall constitute a binding order for the quantities of Virexxa specified therein (the “Firm Commitment”), and the following three (3) months of the Forecast shall be non-binding, good faith estimates.
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(ii) Purchase Orders. On or before the first (1st) day of each calendar month, Xenetic shall submit a purchase order for the Firm Commitment portion of the Forecast, as to which no purchase order has been previously submitted, which specifies the actual quantities of Virexxa to be delivered to Xenetic hereunder for the relevant calendar month and the requested shipping dates for each order (“Purchase Order”). As the Forecast contains Firm Commitments for the first three (3) months, the Purchase Orders to be presented during such months, may vary in quantities through such three (3) months, but the summarized quantities for the said period must meet the quantities as stated in the Firm Commitment. All Purchase Orders shall reflect orders of a size that the Parties have agreed are within the reasonably anticipated capacity of Kevelt and/or Pharmsynthez.
(iii) Raw Material or Capacity Shortage. In the event that Kevelt and/or Pharmsynthez is unable to supply Xenetic with Virexxa in the quantities ordered by Xenetic in accordance with Section 2.05(a)(ii), due to Kevelt’s and/or Pharmsynthez’s insufficient supplies of raw materials necessary to manufacture Virexxa or other manufacturing capacity constraints, Kevelt and/or Pharmsynthez shall use commercially reasonable efforts to equitably allocate available raw materials or manufacturing capacity, as the case may be, in a manner consistent with the Parties’ anticipated needs. Notwithstanding the foregoing, Kevelt and/or Pharmsynthez shall prioritize allocation of manufacturing capacity and raw materials to the manufacture of Virexxa for Xenetic.
(iv) Xenetic Modification or Cancellation. Xenetic may request modification of the delivery date or quantity of Virexxa in a Purchase Order only by submitting a written change order to the Party to whom such Purchase Order was submitted, though such modification request shall not change the amount of Virexxa Xenetic is to purchase based on the then relevant Forecast as set forth in Section 2.05(a)(i). Such change order shall be effective and binding against the Party to whom the Purchase Order was submitted only upon written acceptance by such Party. Notwithstanding the foregoing, Xenetic shall remain responsible for the Firm Commitment portion of the Forecast. The manufacturing Party (Kevelt and/or Pharmsynthez) shall notify Xenetic of its approval or rejection of any such change order within fourteen (14) business days after receipt thereof.
(v) Transitional Period Plan. Upon notice by Xenetic of Xenetic’s intent to transfer the manufacturing to itself or a third party manufacturer selected by Xenetic at Xenetic’s sole discretion, the Parties shall negotiate in good faith and devise a transitional period plan which will set forth, among other things, the Parties’ responsibilities relating to the manufacture of Virexxa during the transfer of manufacturing technology from Kevelt and/or Pharmsynthez to Xenetic, the time frame for such transfer, and the Parties’ mutually determined collaborative and comprehensive plan that will ensure a supply of Virexxa and a smooth transition of manufacturing of Virexxa from Kevelt and/or Pharmsynthez to Xenetic.
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Article III.
Section 3.01 Kevelt and/or Pharmsynthez Provision of Information and Documents to Xenetic
(a) Following entry of the Parties into this Transition and Resupply Agreement, Kevelt and Pharmsynthez shall provide to Xenetic the following within thirty sixty (60) days of the Effective Date:
(i) a list all notebooks, records, data, results, information, filings, regulatory papers submissions and submission related correspondence and information regarding Virexxa requested or ordered by Xenetic or known by Kevelt and/or Pharmsynthez to be necessary for Xenetic to carry out the research, development and commercialization of Virexxa® pursuant to the terms of the IP Asset Purchase Agreement, whether in paper, electronic or some other form, including their location, the identity of all individuals with access to them and the date such notebooks, records, data, results, information, filings, regulatory papers, information shall be provided to Xenetic;
(ii) all copies of original notebooks, records, data, results, filings, submissions and submission related correspondence regulatory papers and information regarding Virexxa, whether in paper, electronic or some other form;
(iii) a list of all Approved Suppliers to Kevelt and/or Pharmsynthez that have been, are or will be involved in the research, development, commercialization, testing or manufacturing of Virexxa, including their addresses and contact information;
(iv) a list of all information, know-how and/or trade secrets in the possession of Kevelt and/or Pharmsynthez that relate in any manner to Virexxa for the Permitted Uses
(v) a list identifying all current stocks of Virexxa in the possession of Kevelt and/or Pharmsynthez or their Affiliates, contractors, or other third parties contracted in any manner by Kevelt and/or Pharmsynthez and the date upon which ownership such stocks of Virexxa shall be transferred to Xenetic, a valuation of the value of such stocks of Virexxa and instructions provided to Xenetic to effectuate the transfer of such stocks of Virexxa to Xenetic; and,
(vi) copies of all documents and records related to communications with regulatory authorities relating to the Permitted Uses, including, those related to current or previous clinical development, manufacturing, product safety and pharmacovigilance.
(vii) copies of all documents and records related to the manufacture of Virexxa, including, the manufacture of bulk API as well as final drug product.
(viii) any other material information or records related in any manner to Virexxa for the Permitted Uses.
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Article IV.
Section 4.02 Regulatory Responsibility and Compliance.
(a) | Kevelt and/or Pharmsynthez agrees to use commercially reasonable efforts to cause, within three (3) months after the Effective Date, the transfer of title and ownership to Xenetic of any and all regulatory approvals and related regulatory filings relating to Virexxa for the Permitted Uses which are owned by Kevelt and/or Pharmsynthez and are filed, issued and in full force and effect as of the Effective Date. |
(b) | Kevelt and/or Pharmsynthez shall be responsible for transferring according to Section 4.02(a) and Xenetic shall be responsible for obtaining and maintaining any establishment licenses or permits required by the FDA or other regulatory authorities, by applicable laws or by regulatory authorities that pertain to Virexxa manufacturing. Kevelt and/or Pharmsynthez hereby grant to Xenetic the right to reference such establishment files for the purpose of obtaining and maintaining regulatory approval. |
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Section 4.04 Recall and Field Corrective Action.
This Section 4.04 shall govern recall arising after the Effective Date from Virexxa manufactured by Kevelt and/or Pharmsynthez for Xenetic. In the event that Xenetic believes a recall, field alert, Virexxa withdrawal, or field corrective action may be necessary with regard to Virexxa provided to Xenetic under this Transition and Resupply Agreement, Xenetic shall immediately notify Kevelt and/or Pharmsynthez in writing. Xenetic shall provide reasonable cooperation and assistance to Kevelt and/or Pharmsynthez required to allow Kevelt and/or Pharmsynthez to respond to a recall, field alert, Virexxa withdrawal, or field corrective action. The cost of a Virexxa product related recall, field alert Virexxa withdrawal or field corrective action shall be borne by Kevelt and/or Pharmsynthez if such recall, field alert, Virexxa withdrawal, or field corrective action is caused in material part by Kevelt and/or Pharmsynthez's breach of its obligations under this Transition and Resupply Agreement, or applicable laws, or by its willful misconduct. Xenetic shall bear responsibility for the cost of a Virexxa product related recall, field alert Virexxa withdrawal or field corrective action for all other reasons.. For purposes of this Section 4.04, the Party bearing the costs of any recall, field alert, Virexxa withdrawal, or field corrective action shall only be required to reimburse the other Party for reasonable, actual and documented out-of-pocket costs incurred by such other Party for such recall, field alert, Virexxa withdrawal, or field corrective action (including costs of retrieving Virexxa already delivered to customers, costs and expenses such other Party is required to pay for notification, shipping and handling charges, and all other costs reasonably related to such recall, field alert, Virexxa withdrawal, or field corrective action), and the cost to replace, or the actual replacement of Virexxa.
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Section 4.06 Quality, Environmental, Health and Safety Audits. Kevelt and/or Pharmsynthez shall permit Xenetic’s personnel or authorized representative, upon reasonable notice, at reasonable intervals, and for reasonable duration during regular business hours, to visit the facility where Virexxa is manufactured, tested, or stored by, or on behalf of, Kevelt and/or Pharmsynthez; or to audit compliance with this Transition and Resupply Agreement, however, that such audits shall be conducted not more than twice in any twelve (12) month period, other than "for cause" audits, which Xenetic shall be entitled to conduct following the implementation of measures in response to letters from the FDA to Kevelt and/or Pharmsynthez pertaining to the manufacture of Virexxa.
All information obtained by Xenetic in any such review, including without limitation the findings and results related thereto, shall be deemed Kevelt and/or Pharmsynthez Confidential Information. Kevelt and/or Pharmsynthez will have responsibility to audit its permitted subcontractors and suppliers at reasonable intervals for compliance with (i) the Specifications, (ii) current GMPs, and (iii) applicable laws. Xenetic shall have the right to confirm audits of subcontractors and suppliers of Kevelt and/or Pharmsynthez for Virexxa manufactured under this Transition and Resupply Agreement.
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Article V.
Cost for Manufacturing and Supply of Virexxa to Xenetic
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Article VI.
Representations and Warranties
Section 6.01 Representations and Warranties of KEVELT AND/OR PHARMSYNTHEZ.
(a) Authorization. Kevelt and/or Pharmsynthez, jointly and severally, represents, warrants and covenants that:
(i) this Transition- and Resupply Agreement has been duly executed and delivered by Kevelt and/or Pharmsynthez and constitutes a valid and binding obligation of Kevelt and/or Pharmsynthez, enforceable against Kevelt and/or Pharmsynthez in accordance with its terms, except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors’ rights generally and by general equitable principles;
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(ii) the execution, delivery and performance of this Manufacturing Agreement have been duly authorized by all necessary action on the part of Kevelt and/or Pharmsynthez, its officers and directors and does not conflict with any agreement, instrument or understanding, oral or written, to which Kevelt and/or Pharmsynthez is a party or by which it may be bound, and, to the best of its knowledge, does not violate any material law or regulation of any court, governmental body or administrative or other agency having authority over it;
(iii) Kevelt and/or Pharmsynthez has full power and authority to perform the obligations set forth herein, and that Kevelt and/or Pharmsynthez is not subject to any order, decree or injunction by a court of competent jurisdiction which may prevent or materially delay the consummation of the transactions contemplated by this Transition and Resupply Agreement;
(iv) Kevelt and/or Pharmsynthez is duly organized, validly existing and in good standing under the laws of the jurisdiction where it is organized; and
(b) | Kevelt and/or Pharmsynthez’s Rights (Virexxa). As of the Effective Date, Kevelt and/or Pharmsynthez, jointly and severally, represent and warrant, with respect to manufacture and supply of Virexxa as of the Effective Date, that to its knowledge, upon reasonable inquiry, the granting of the rights to Xenetic hereunder does not conflict with any contractual obligation to any Third Party. |
(c) | No Conflicting Agreements. Kevelt and/or Pharmsynthez, jointly and severally, represent and warrant that they have not to their knowledge granted, and during the term of this Transition and Resupply Agreement will not grant, any right to a Third Party that would conflict with the licenses and rights granted to Xenetic hereunder. |
Section 6.02 Representations and Warranties of Xenetic.
(a) | Authorization. Xenetic represents, warrants and covenants that: |
(i) this Transition- and Resupply Agreement has been duly executed and delivered by Xenetic and constitutes a valid and binding obligation of Xenetic, enforceable against Xenetic in accordance with its terms, except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors’ rights generally and by general equitable principles;
(ii) the execution, delivery and performance of this Transition and Resupply Agreement by Xenetic have been duly authorized by all necessary action on the part of Xenetic, its officers and directors, and does not conflict with any agreement, instrument or understanding, oral or written, to which Xenetic is a party or by which it may be bound, and, to the best of its knowledge, does not violate any material law or regulation of any court, governmental body or administrative or other agency having authority over it;
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(iii) Xenetic has full power and authority to perform the obligations set forth herein, and that Xenetic is not subject to any order, decree or injunction by a court of competent jurisdiction which may prevent or materially delay the consummation of the transactions contemplated by this Transition and Resupply Agreement; and
(iv) Xenetic is duly organized, validly existing and in good standing under the laws of the jurisdiction where it is organized.
(b) | No Impairing Agreements. Xenetic represents, warrants and covenants that, during the term of this Transition and Resupply Agreement, it will not knowingly enter into any agreements, oral or written, that would in any way impair its ability to fulfill its obligations under this Transition and Resupply Agreement. |
Article VII.
Limitations on Representations and Warranties
Limitations on Representations and Warranties. THE LIMITED WARRANTIES CONTAINED IN ARTICLE 5 ARE THE SOLE WARRANTIES GIVEN BY THE PARTIES HEREUNDER, AND ARE MADE EXPRESSLY IN LIEU OF AND EXCLUDE ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OR OTHERWISE, AND ALL OTHER EXPRESS OR IMPLIED REPRESENTATIONS AND WARRANTIES PROVIDED BY COMMON LAW, STATUTE OR OTHERWISE ARE HEREBY DISCLAIMED BY BOTH PARTIES. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR INDIRECT, PUNITIVE, SPECIAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES OF ANY KIND, INCLUDING WITHOUT LIMITATION, LOSS OF PROFITS AND LOSS OR INTERRUPTION OF BUSINESS. THE FOREGOING PROVISION SHALL NOT BE CONSTRUED TO LIMIT A PARTY'S INDEMNIFICATION OBLIGATION UNDER THIS TRANSITION AND RESUPPLY AGREEMENT FOR THIRD PARTY CLAIMS WHICH MAY INCLUDE CONSEQUENTIAL, PUNITIVE OR OTHER TYPES OF DAMAGES.
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Article VIII.
(a) | No Disclosure or Use. During the term of this Transition and Resupply Agreement, and for a period of ten (10) years thereafter, each Party shall keep confidential all information received from the other Party (the “Confidential Information”), and shall not disclose or use such Confidential Information without the other Party’s explicit written consent, except to the extent contemplated by this Transition and Resupply Agreement. This restriction shall not, however, prevent disclosure of such Confidential Information if and to the extent that disclosure is clearly required by law; provided that the disclosing Party informs the other Party without delay of any such requirement, in order to allow such other Party to object to such disclosure and to seek an appropriate protective order or similar protection prior to disclosure. | |
(b) | No Misappropriation. The Parties agree that the transfer of rights in regulatory documentation by one Party to the other Party pursuant to this Transition and Resupply Agreement shall not, to the actual knowledge of the transferring Party, misappropriate the proprietary or trade secret information of a Third Party. |
(c) | Exceptions. The above obligations shall not apply, or shall cease to apply, to Confidential Information of the disclosing Party which: |
(i) is now, or hereafter becomes, through no act or failure to act on the part of the receiving Party, generally known or available;
(ii) is known by the receiving Party at the time of receiving such Confidential Information, as evidenced by its written records;
(iii) is hereafter furnished to the receiving Party by a Third Party, as a matter of right and without restriction on disclosure;
(iv) is independently developed by the receiving Party without resort to the Confidential Information of the disclosing Party or any breach of this Article 7;
(v) is entered into evidence in a legal proceeding or submitted for use in a dispute resolution proceeding to enforce one or more rights of a Party under this Transition and Resupply Agreement; provided that the receiving Party shall give the disclosing Party prompt written notice and sufficient opportunity to object to such use or disclosure, or to request confidential treatment of the Confidential Information; or
(vi) is the subject of a written permission to disclose provided by the disclosing Party.
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Section 8.02 Permitted Disclosures.
(a) Each Party may disclose Confidential Information: (i) for the purpose of preparing, filing, prosecuting and maintaining Patents; (ii) for obtaining Regulatory Approvals; (iii) for the manufacture, marketing, distribution or sale of Virexxa; or (iv) to any individuals that are required by law, contract or otherwise not to use or disclose such Confidential Information except as permitted by this Transition and Resupply Agreement. Each Party will use at least the same standard of care as it uses to protect proprietary or confidential information of its own to ensure that such individuals do not disclose or make any unauthorized use of the Confidential Information.
(b) In order to exploit rights retained by or granted to the Parties under this Transition and Resupply Agreement, each Party may publish or publicly present any research or other data which may involve the disclosure of Confidential Information; provided that the publishing Party agrees to furnish the non-publishing Party with copies of any proposed oral, written, graphic or electronic public disclosure prior to submission for publication or presentation. The non-publishing Party shall then have thirty (30) days to review such contemplated publication or presentation. At the end of the thirty (30) day period, the publishing Party may proceed with the contemplated publication or presentation unless (i) the non-publishing Party reasonably requests additional time to fully protect its intellectual property rights, in which case any such contemplated publication or presentation containing the details of a patentable invention must be withheld by the publishing Party for an additional period of thirty (30) days or until a patent application is filed thereon by the non-publishing Party, whichever is earlier in time; or (ii) the non-publishing Party reasonably requests that trade secret information or other Confidential Information of the non-publishing Party be redacted from the contemplated publication or presentation, in which case any such request shall be honored by the publishing Party.
Section 8.03 Disclosure of Transition and Resupply Agreement. Except as required by law, neither Kevelt and/or Pharmsynthez nor Xenetic shall release to any Third Party or publish in any way any Confidential Information with respect to the terms of this Transition and Resupply Agreement or concerning their cooperation without the prior written consent of the other Party, which consent will not be unreasonably withheld or delayed; provided; however, that either Party may disclose the terms of this Transition and Resupply Agreement (a) to the extent required to comply with applicable laws, and (b) in any instance where a Party becomes legally compelled (by deposition, interrogatory, request for documents, subpoena, civil investigative demand or similar process). Notwithstanding any other provision of this Transition and Resupply Agreement, each Party may disclose the terms of this Transition and Resupply Agreement (i) to its legal counsel or (ii) to lenders, investment bankers, attorneys, financial advisors and other financial institutions of its choice solely for purposes of financing the business operations of such Party, or to a potential acquirer of all or substantially all of the assets or equity interests of such Party (a) upon the written consent of the other Party, or (b) if the Party disclosing such terms obtains a signed confidentiality agreement with such intended recipient with respect to such Confidential Information, upon terms substantially similar to those contained in this Article 7.
Section 8.04 Confidential Information of Each Party. The Parties agree that the material financial terms of the Transition and Resupply Agreement shall be considered the Confidential Information of both Parties.
Section 8.05 Employee Obligations. Each Party shall undertake to ensure that all of its employees who have access to Confidential Information are under obligations of confidentiality to such Party.
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Article IX.
(a) | Term. The supply of Virexxa by Kevelt and/or Pharmsyntez shall continue until as the earliest of (i) such time as Xenetic requests the transfer of the manufacturing process to itself or a Third Party manufacturer selected by Xenetic pursuant to Article II of this Transition, Services and Resupply Agreement; (ii) such time as Xenetic discontinues the development of a Virexxa clinical or commercial program; (iii) eight (8) years from the Effective Date or (iv) upon Xenetic’s written notice to be provided no later than three (3) months prior to the termination date. |
(b) | Termination with Cause. Either Party may terminate this Transition and Resupply Agreement for cause pursuant to Sections 9.02 and 9.03. |
(c) | Accrued Obligations. Except where explicitly provided elsewhere herein, termination of this Transition and Resupply Agreement for any reason, will not affect: (i) obligations of the Parties, including any payments which have accrued as of the date of termination or expiration, or (ii) rights and obligations of the Parties at law or in equity which, from the context thereof, are intended to survive termination of this Transition and Resuupply Agreement; nor prejudice any Party’s right to obtain performance of any obligation then due and owing. |
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Article X.
Product Liability, Indemnification and Insurance
Section 10.03 Indemnification Procedures. Promptly after receipt by a Xenetic Indemnitee of notice of any pending or threatened claim against it (an “Action”), such Xenetic Indemnitee shall give written notice to Kevelt and/or Pharmsynthez to look for indemnification pursuant to this ArticleX (the “Indemnifying Party”) of the commencement thereof. The failure to so notify the Indemnifying Party shall not relieve it of any liability that it may have to any Indemnitee hereunder, except to the extent the Indemnifying Party demonstrates that it is prejudiced thereby. In case any Action that is subject to indemnification under Section 10.02 shall be brought against an Xenetic Indemnitee and it shall give written notice to Kevelt and/or Pharmsynthez of the commencement thereof, Kevelt and/or Pharmsynthez shall be entitled to participate therein and, if it so desires, to assume the defense thereof with counsel reasonably satisfactory to such Xenetic Indemnitee and, after notice from Kevelt and/or Pharmsynthez to the Xenetic Indemnitee of its election to assume the defense thereof, Kevelt and/or Pharmsynthez shall not be liable to such Xenetic Indemnitee under this ArticleX for any fees of other counsel or any other expenses, in each case subsequently incurred by such Xenetic Indemnitee in connection with the defense thereof. Notwithstanding Kevelt’s and/or Pharmsynthez’s election to assume the defense of any such Action that is subject to indemnification under Section 10.02, the Xenetic Indemnitee shall have the right to employ separate counsel and to participate in the defense of such Action at its own expense. If a Kevelt and/or Pharmsynthez assumes the defense of such Action, no compromise or settlement thereof may be effected by Kevelt and/or Pharmsynthez without the Xenetic Indemnitee’s written consent, which consent shall not be unreasonably withheld or delayed, unless (i) there is no finding or admission of any violation of law or any violation of the rights of any Third Party and no effect on any other claims that may be made against the Xenetic Indemnitee and (ii) the sole relief provided is monetary damages that are paid in full by Kevelt and/or Pharmsynthez.
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Section 10.04 Compliance. The Parties shall comply fully with all applicable laws and regulations in connection with their respective activities under this Transition and Resupply Agreement.
Section 10.05 Kevelt and Pharmsynthez Insurance.
(a) Kevelt and Pharmsynthez shall, until expiration of the last batch of Virexxa manufactured hereunder, by Kevelt and/or Pharmsynthez, obtain and maintain at their own cost and expense, any combination of insurance, for its commercial liability, including, but not limited to, product liability and contractual liability insurance, with respect to its activities hereunder.
(b) Such insurance or self-insurance shall be in such amounts and subject to such deductibles as the Parties may agree based upon standards prevailing in the industry at the time, but under no circumstances shall be less than: (i) Four Million Dollars ($4,000,000) per occurrence for damage, injury and/or death to persons prior to regulatory authority approval of Virexxa; (ii) Ten Million Dollars ($10,000,000) per occurrence for damage, injury and/or death to persons after regulatory authority approval of Virexxa; or One Million Dollars ($1,000,000) per occurrence for damage/or injury to property. Such insurance shall be written to cover claims incurred, discovered, manifested, or made in connection with clinical development and commercial sale of Virexxa. Upon written request of Xenetic, Kevelt and/or Pharmsynthez shall provide to Xenetic copies of its Certificates of Insurance.
(c) All insurance required of Kevelt and/or Pharmsynthez under this Transition and Resupply Agreement shall, be through a commercially based insurance company, such insurance shall (i) be issued by reputable, financially sound companies; (ii) provide that the insurance company will endeavor to provide at least thirty (30) days' notice of cancellation of coverage, non-renewal or material change of coverage to both Xenetic and Kevelt and/or Pharmsynthez, but its failure to do so shall impose no penalty or additional obligations under this Transition and Resupply Agreement; and (iii) contain a severability of interest or separation of the insureds provision, affording defense and coverage for an insured in the event of a claim brought by another insured.
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Article XI.
Section 11.01 Governing Law. This Transition and Resupply Agreement shall be governed, interpreted and construed in accordance with the laws of the United States and the State of Massachusetts, without regard to conflict of laws principles thereof.
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If to Kevelt and/or Pharmsynthez: |
AS XXXXXX 0/0, Xxxxxxxxxxx Xxx., 00000 Xxxxxxx, Xxxxxxx Facsimile: x000 000 0000 E-mail: x.xxxxxx@xxxxxx.xx Attention: Xxxxx Ahtloo
OJSC Pharmsynthez 188663 Leningradskaya oblast, Vsevolozhsky rayon, urban village Kuzmolovsky, station Capitolovo, № 134 liter 1, Russian Federation Facsimile: 0 (000) 000-0000 E-mail: xxxxxxxxxxx@xxxxxxxxxxxx.xxx Attention: Xxxx Xxxxxxxxxx, CEO |
with a copy to: |
Xxxxxxxxx & Xxxxxxx LLP The New York Times Building 000 Xxxxxx Xxxxxx Xxx Xxxx, Xxx Xxxx 00000 Facsimile: (000) 000-0000 Email: xxxxx@xxx.xxx Attention: Xxxxxxx Xxxx |
If to Xenetic: |
00 Xxxxxx Xxxxxx, Xxxxx 000 Xxxxxxxxx, Mass. 02421 Facsimile: [FAX NUMBER] E-mail: x.xxxxxxx@xxxxxxxxxx.xxx Attention: Xxxxx Xxxxxxx, CEO |
with a copy to: |
Xxxx, Xxxxxxxxxx & Xxxxxxxxx LLP 000 X. Xxxxxx Xxxxx, Xxxxx 0000 Xxxxxxx, XX 00000 Facsimile: 000-000-0000 E-mail: xxxxxxxxxx@xxxxxxx.xxx Attention: Xxxxxxxx X. Xxxxxxxxx, Esq. |
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[Signature Page Follows]
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SELLER:
AS KEVELT
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Name: Xxxxx Ahtloo Title: |
PARENT:
OJSC PHARMSYNTHEZ
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Name: Xxxxx X. Xxxxxxxxxx Title: | |
BUYER:
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Name: Title: |
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