Document:

Exhibit 10.6
INFORMATION IN THIS EXHIBIT IDENTIFIED BY BRACKETS IS CONFIDENTIAL AND HAS BEEN EXCLUDED PURSUANT TO ITEM 601(B)(10)(IV) OF REGULATION S-K BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CASI PHARMACEUTICALS, INC. IF PUBLICLY DISCLOSED.
*** TRIPLE ASTERISKS DENOTE OMISSIONS
LICENSE AGREEMENT
This LICENSE AGREEMENT (the “Agreement”) is effective as of September 17, 2014 (the “Effective Date”) by and between Talon Therapeutics, Inc., a Delaware corporation (“Talon”) and CASI Pharmaceuticals, Inc., a Delaware corporation (“Licensee”).  Licensee and Talon are each referred to herein by name or, individually, as a “Party” or, collectively, as “Parties.”
BACKGROUND
A.Talon owns and controls rights in and to a product commercially known as “Marqibo®”, a sphingosomal vincristine, described as a liposome that includes sphingomyelin and cholesterol and contains encapsulated vincristine, wherein the sphingomyelin comprises less than 20% dihydrosphingomyelin (the “Product”).
B.Licensee desires to obtain a license to develop and commercialize the Product for use in the Field in the Licensee Territory (each capitalized term as defined below), and Talon desires to grant Licensee such a license.
NOW, THEREFORE, in consideration of the mutual covenants and agreements provided herein below and other consideration, the receipt and sufficiency of which is hereby acknowledged, Licensee and Talon hereby agree as follows:
ARTICLE 1
DEFINITIONS
The following capitalized terms shall have the meanings given in this Article 1 when used in this Agreement:
1.1“AAA” has the meaning set forth in Section 10.2.
1.2“AAA Rules” has the meaning set forth in Section 10.2.
1.3“Additional Products” has the meaning set forth in Section 3.4.1.
1.4“Affiliate” shall mean with respect to either Party, any Person controlling, controlled by or under common control with such Party, for so long as such control exists.  For purposes of this Section 1.4 only, “control” shall mean (i) direct or indirect ownership of fifty percent (50%) or more of the stock or shares having the right to vote for the election of directors of such corporate entity or (ii) the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such entity, whether through the ownership of voting securities, by contract or otherwise.

1.5“Agreement” has the meaning set forth in the Preamble including any schedules, exhibits, annexures, attached hereto or any amendments and modifications.
1.6“Agreement Year” shall mean a twelve (12) month period from the Effective Date and each anniversary thereof.
1.7“Applicable Laws” shall mean, with respect to a Party’s activities under this Agreement, any and all laws, ordinances, orders, rules, rulings, directives and regulations of any kind whatsoever of any governmental or regulatory authority within the applicable jurisdiction applicable to such Party’s activities.
1.8“Auditing Party” has the meaning set forth in Section 5.5.
1.9“Business Day” shall mean any day other than a Saturday, Sunday or any other day on which commercial banks in the United States, the People’s Republic of China or Hong Kong are authorized or required by law to remain closed.
1.10“Chairperson” has the meaning set forth in Section 2.1.3.
1.11“Change of Control” means, with respect to either Party, (i) the sale of all or substantially all of such Party’s assets or business relating to this Agreement; (ii) a merger, consolidation, share exchange or other similar transaction involving such Party and any Third Party which results in the holders of the outstanding voting securities of such Party immediately prior to such merger, consolidation, share exchange or other similar transaction ceasing to hold more than fifty percent (50%) of the combined voting power of the surviving, purchasing or continuing entity immediately after such merger, consolidation, share exchange or other similar transaction, or (iii) the acquisition by a person or entity, or group of persons or entities acting in concert, of more than fifty percent (50%) of the outstanding voting equity securities of such Party; in all cases of clauses (i)-(iii), where such transaction is to be entered into with any person or group of persons other than the other Party or its Affiliates.
1.12“Commercialization” shall mean, with respect to the Product, any and all processes and activities conducted to establish and maintain sales for the Product (including with respect to reimbursement and patient access), including offering for sale, detailing, selling (including launch), marketing (including education and advertising activities), promoting, storing, transporting, distributing, and importing the Product, but shall exclude Development of the Product.  For clarity, Commercialization shall include the manufacture of the Product in support of the foregoing processes and activities, including, to the extent applicable, packaging, labeling and other finishing activities, quality control and assurance testing, in each case, with respect to such product.  “Commercialize” and “Commercializing” shall have their correlative meanings.
1.13“Commercially Reasonable Efforts” shall mean:
(a)those efforts and resources that Licensee would use were it developing, promoting and detailing its own pharmaceutical products which are of similar market potential as the Product, taking into account product labeling, market potential, past performance, economic return,
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the regulatory environment and competitive market conditions in the therapeutic area, all as measured by the facts and circumstances at the time such efforts are due, and
(b)with respect to any Product, commercially reasonable efforts of a Person to carry out its obligations, and to cause its Affiliates and licensees and sublicensees to carry out their respective obligations, using such efforts and employing such resources normally used by Persons of comparable resources in the specialty pharmaceutical business relating to the research, development or commercialization of a product, that is of similar market potential at a similar stage in its development or product life, taking into account issues of market exclusivity, product profile, including efficacy, safety, tolerability and convenience, the competitiveness of alternate products in the marketplace or under development, the availability of existing forms or dosages for other indications, the launch or sales of a similar product by such Person or third parties, the regulatory environment and the profitability of the applicable product (including pricing and reimbursement status achieved), and other relevant factors, including technical, commercial, legal, scientific and/or medical factors.  Factors beyond the reasonable control of a Person, including without limitation, regulatory delays, safety findings, unforeseen technical challenges, the failure of a Product to meet necessary scientific or regulatory endpoints, and force majeure events shall be taken into account when evaluating whether a Person’s efforts under this Section 1.13(b)
1.14“Confidential Information” has the meaning set forth in Section 7.1.
1.15“Control” shall mean, with respect to any Intellectual Property right, possession by a party (including its Affiliates) of the right (whether by ownership, license or otherwise) to grant to another party a license or a sublicense under such Intellectual Property right without violating the terms of any agreement or other arrangement with any third party.  “Controlled” and “Controlling” shall have their correlative meanings.  Notwithstanding anything to the contrary in this Agreement, in the event that a Third Party acquires (including by merger or consolidation) a Party or an Affiliate of a Party, or a Party or an Affiliate of a Party transfers to a Third Party all or substantially all of its assets to which this Agreement relates (such Third Party and its Affiliates immediately prior to such acquisition or transfer (the “Subject Transaction”), collectively, the “Acquiring Entities”), the following shall not be deemed to be Controlled by such Party or its Affiliates for purposes of this Agreement: (i) any subject matter owned or controlled by any Acquiring Entity immediately prior to the effective date of such Subject Transaction, and (ii) any subject matter developed or acquired by or on behalf of any Acquiring Entity after a Subject Transaction independently, without accessing or practicing subject matter within the Licensed Technology or any other technology or information made available to such Party under this Agreement.
1.16“Development” shall mean, with respect to the Product, any and all processes and activities conducted to obtain and maintain Regulatory Approval for the Product, including preclinical testing, test method development and stability testing, toxicology, formulation, process development, quality assurance/control development, statistical analysis, clinical studies (including trials for additional indications for the Product for which a Regulatory Approval has been obtained), quality of life assessments, pharmacoeconomics, post-marketing studies, label expansion studies, regulatory affairs, and further activities relating to the clinical development or preparation of such product for filing MAAs with Regulatory Authorities and Commercialization.  “Develop” and “Developing” shall have their correlative meanings.
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1.17“Dispute” has the meaning set forth in Section 10.1.
1.18“Effective Date” has the meaning set forth in the Preamble.
1.19“Enforcing Party” has the meaning set forth in Section 6.5.5.
1.20“Field” shall mean the use of the Product for the diagnosis, prevention and therapy of all diseases, conditions and disorders in humans.
1.21“First Commercial Launch” shall mean the first shipment of the Product in commercial quantities for commercial sale to a Third Party in Licensee Territory after receipt of all applicable Regulatory Approvals therefor from the applicable Regulatory Authority in Licensee Territory.
1.22“Foreign Marketing Approval” has the meaning set forth in Section 4.1.6.
1.23“Imported Product Regulatory Approval” has the meaning set forth in Section 4.1.6.
1.24“Indemnify” has the meaning set forth in Section 8.5.1.
1.25“Initial Transfer” has the meaning set forth in Section 4.2.3.
1.26“Intellectual Property” shall mean intellectual property rights of every kind and nature throughout the world, however denominated, including all rights and interests pertaining to or deriving from:
(a)Patent and Know-How;
(b)trademarks, trade names, service marks, service names, brands, trade dress and logos, domain names, and the goodwill and activities associated therewith;
(c)copyrights, works of authorship, rights of privacy and publicity, moral rights, and similar proprietary rights of any kind or nature, in all media now known or hereafter created; and
(d)any and all registrations, applications, recordings, licenses, statutory rights, common-law rights and rights relating to any of the foregoing.
1.27“International Accounting Standards” shall mean the International Financial Reporting Standards or U.S. Generally Accepted Accounting Principles.
1.28“Invention” has the meaning set forth in Section 6.1.2.
1.29“Investment Agreement” has the meaning set forth in Section 5.1.
1.30“JPC” has the meaning set forth in Section 2.1.1.
1.31“Joint Patents” has the meaning set forth in Section 6.1.1(c).
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1.32“Joint Inventions” has the meaning set forth in Section 6.1.1(c).
1.33Intentionally Omitted.
1.34“Know-How” shall mean inventions, business, marketing, technical and manufacturing information, know-how and materials, including technology, software, instrumentation, specifications, devices, data, compositions, formulas, biological materials, assays, reagents, constructs, compounds, discoveries, procedures, processes, practices, protocols, methods, techniques, results of experimentation or testing, knowledge, trade secrets, skill and experience, in each case whether or not patentable or copyrightable.
1.35“Licensee” has the meaning set forth in the Preamble.
1.36“Licensee Indemnitees” has the meaning set forth in Section 8.5.1.
1.37“Licensee Inventions” has the meaning set forth in Section 6.1.1(b).
1.38“Licensee Know-How” shall mean any and all Know-How Controlled by Licensee or its Affiliates during the Term that is reasonably necessary or useful for the Development or Commercialization of the Product for use in the Field.  Licensee Know-How shall also include Licensee Inventions.
1.39“Licensee Territory” shall mean People’s Republic of China including, Hong Kong, Macau and Taiwan.
1.40“Licensee Trademarks” has the meaning set forth in Section 4.3.4(a).
1.41“Losses” has the meaning set forth in Section 8.5.1.
1.42“MAA” shall mean a new drug application or similar application or submission filed with or submitted to any Regulatory Authority to obtain permission to commence marketing and sales of the Product in any particular jurisdiction.
1.43“Made” has the meaning set forth in Section 6.1.2.
1.44“Manufacturing Cost” shall mean Talon’s, or Non-Talon Foreign Regulatory Approval Holder’s, bona fide and actual manufacturing cost or bona fide invoiced cost from a Third Party manufacturer.
1.45“Material Impact” shall mean a material adverse effect on the regulatory status or commercial sales of the Product.
1.46“Material Impact Matters” has the meaning set forth in Section 2.3.
1.47“Net Sales” has the meaning set forth in the Upstream Stream Licenses.
1.48“Non-Talon Foreign Marketing Approval Holder” has the meaning set forth in Section 4.1.6.
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1.49“Party” or “Parties” has the meaning set forth in the Preamble.
1.50“Patent” shall mean any of the following, whether existing now or in the future anywhere in the world: (i) any issued patent, including inventor's certificates, substitutions, extensions, confirmations, reissues, re-examination, renewal or any like governmental grant for protection of inventions; and (ii) any pending application for any of the foregoing, including any continuation, divisional, substitution, continuations-in-part, provisional and converted provisional applications.
1.51“Payment Period” has the meaning set forth in Section 5.2.2.
1.52“Person” shall mean any individual, corporation, partnership, association, joint-stock company, trust, unincorporated organization or government or political subdivision thereof.
1.53“Prior CDA” has the meaning set forth in Section 7.3.
1.54“Product” has the meaning set forth in the Preamble.
1.55“Prosecution and Maintenance” shall mean, with respect to a Patent, the preparing, filing, prosecuting and maintenance of such Patent, as well as re-examinations, reissues, requests for Patent term extensions and the like with respect to such Patent, together with the conduct of interferences, the defense of oppositions and other similar proceedings with respect to the particular Patent.
1.56“Regulatory Approval” shall mean, with respect to the Product in a particular jurisdiction, approval or other permission by the applicable Regulatory Authorities sufficient to initiate manufacturing, importing, marketing and sales of such product, including pricing and reimbursement approvals.
1.57“Regulatory Authority” shall mean any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the Development, Commercialization or other use or exploitation (including the granting of Regulatory Approvals) of the Product in any jurisdiction, including the FDA.
1.58“Regulatory Filing” shall mean any filing, application, or submission with any Regulatory Authority, including MAAs and authorization, approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case with respect to the Product.
1.59“Senior Executives” has the meaning set forth in Section 2.3.
1.60“Supply Agreement” has the meaning set forth in Section 4.5.2.
1.61“Talon” has the meaning set forth in the Preamble.
1.62“Talon Copyrights” shall mean all works of authorship (including advertising, marketing and promotional materials, artwork, labeling, and other works of authorship), and all
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copyrights, moral rights and other rights and interests thereto throughout the Licensee Territory, whether or not registered, that are (i) Controlled by Talon or its Affiliates, and (ii) are delivered to Licensee by Talon for use in connection with the Product.
1.63“Talon Indemnitees” has the meaning set forth in Section 8.5.2.
1.64“Talon Inventions” has the meaning set forth in Section 6.1.1(a).
1.65“Talon Know-How” shall mean any and all Know-How Controlled by Talon or its Affiliates during the Term that is reasonably necessary or useful for the Development or Commercialization of the Product for use in the Field.  Talon Know-How shall also include Talon Inventions.
1.66“Talon Patents” shall mean any and all Patents Controlled by Talon or its Affiliates during the Term claiming (i) the composition of or formulation for, (ii) any method, composition or apparatus for the manufacture of, or (iii) any method of using in the Field, in each case of clause (i), (ii), and (iii), the Product.  Talon Patents shall also include Patents that claim Talon Inventions.  A list of Talon Patents is appended hereto as Exhibit 1.66 and will be updated periodically to reflect changes thereto during the Term.
1.67“Talon Product Marks” has the meaning set forth in Section 4.3.4(c).
1.68“Talon Technology” shall mean the Talon Know-How, Talon Patents and Talon Copyrights.
1.69“Talon Trademarks” shall mean the trademarks and service marks, the goodwill associated therewith, and all registrations and applications relating thereto, that are (i) Controlled by Talon or its Affiliates, during the Term, and (ii) used by Talon in connection with the Product.  A list of Talon Trademarks is appended hereto as Exhibit 1.69 and will be updated periodically to reflect changes thereto during the Term.
1.70“Talon Territory” shall mean all countries and territories throughout the world other than the Licensee Territory.
1.71“Tekmira” shall mean Tekmira Pharmaceuticals Corporation (f/k/a Inex Pharmaceuticals Corporation).
1.72“Term” has the meaning set forth in Section 9.1.
1.73“Territory” shall mean all of the countries and territories in the world.  A Party’s respective “Territory” shall mean, in the case of Talon, the Talon Territory, and in the case of Licensee, the Licensee Territory.
1.74“Third Party” shall mean any Person other than Licensee, Talon or their respective Affiliates.
1.75“Third-Party Claim” has the meaning set forth in Section 8.5.1.
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1.76“Upfront Note” has the meaning set forth in Section 5.1.
1.77“Upstream Licenses” shall mean (i) that certain Amended and Restated License Agreement, dated April 30, 2007, by and between Tekmira Pharmaceuticals Corporation (f/k/a Inex Pharmaceuticals Corporation) and Talon Therapeutics, Inc. (f/k/a Hana Biosciences, Inc.), as amended on May 27, 2009 and September 20, 2010, (ii) that certain Termination Agreement, dated May 6, 2002 by and between Tekmira Pharmaceuticals Corporation (f/k/a Inex Pharmaceuticals Corporation) and British Columbia Cancer Agency, as amended by that certain Amendment to Termination Agreement, dated effective May 6, 2002, (iii) that certain Patent Technology License Agreement, dated February 14, 2000 by and between The University of Texas M. D. Anderson Cancer Center and Tekmira Pharmaceuticals Corporation (f/k/a Inex Pharmaceuticals Corporation) and assigned to Talon pursuant to that certain Assignment and Novation Agreement, dated April 30, 2007 and (iv) that certain Contingent Value Rights Agreement, dated as of January 16, 2012, by and between Talon Pharmaceuticals, Inc., Talon Therapeutics, Inc. and Corporate Stock Transfer, Inc. as Rights Agent (“Rights Agent”) (which the Parties acknowledge is not a license but is included in this definition for administrative convenience).  The Parties agree to amend this Section 1.77 to include such other agreement that Talon or its Affiliates have entered into as of the Effective Date that may affect Licensee’s exercise of the rights granted under this Agreement.
1.78“Upstream Licensor” shall mean the licensor under the Upstream License, or the Rights Agent with respect to the Contingent Value Rights Agreement.
1.79“Upstream Payments” has the meaning set forth in Section 5.2.1.
1.80“Wind-Down Period” has the meaning set forth in Section 9.8.2.
ARTICLE 2
GOVERNANCE
2.1Joint Product Committee.
2.1.1Establishment.  Promptly after the Effective Date, Licensee and Talon shall establish a joint product committee (the “JPC”) to oversee, review and coordinate the activities of Licensee under this Agreement, including the Development and Commercialization of the Product for use in the Field in the Licensee Territory.
2.1.2Responsibilities.  The JPC shall be responsible for: (i) overseeing, reviewing and monitoring Licensee’s activities under this Agreement including, without limitation, any clinical trials proposed to be conducted by Licensee; (ii) facilitating access to and the exchange of information between the Parties related to the Development and/or Commercialization of the Product for use in the Field in the Licensee Territory; and (iii) undertaking and/or approving such other matters as are specifically provided for the JPC under this Agreement.
2.1.3Membership.  The JPC shall be comprised of an equal number of representatives from each of Talon and Licensee and unless otherwise agreed such number shall be two (2) senior representatives from each Talon and Licensee.  Either Party may replace its respective JPC representatives at any time with prior notice to the other Party, provided, that such replacement
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is of comparable authority and scope of functional responsibility within that Party’s organization as the person he or she is replacing.  Unless otherwise agreed by the Parties, the JPC shall have at least one representative with relevant decision-making authority from each Party such that the JPC is able to effectuate all of its decisions within the scope of its responsibilities.  Licensee shall select one of its representatives as the chairperson for the JPC (the “Chairperson”) and the Licensee may replace the Chairperson upon written notice to Talon.  The Chairperson shall be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting (which agenda will include every matter requested by either Party), and preparing and issuing minutes of each meeting within thirty (30) days thereafter.
2.2Meetings.  The JPC shall hold meetings (either in person, by teleconference or videoconference) at such times and places as the Parties may mutually agree, provided, that, unless the Parties agree otherwise, the JPC shall meet at least semi-annually during the Development of the Product for use in the Field in the Licensee Territory, and at least annually thereafter.  Each Party shall bear its own costs associated with attending such meetings.  As appropriate, other employees of the Parties may attend the JPC’s meetings as nonvoting observers, but no Third Party personnel may attend unless otherwise agreed by the Parties.  At the request of Talon and with prior written approval of Licensee, which shall not be unreasonably withheld, Third Party licensees of Talon for the development and commercialization of the Product for use in the Field in the Talon Territory may attend the JPC’s meetings as nonvoting participants if they have agreed to confidentiality terms at least as restrictive as those set forth in this Agreement.  Each Party may also call for special meetings to resolve particular matters requested by such Party.
2.3Decision Making.  Decisions of the JPC shall be made by consensus of the members present in person or by other means (e.g., teleconference) at any meeting, with at least one representative from each Party participating in such vote.  The members of the JPC shall at all times use good faith efforts to reach consensus on matters properly referred to the JPC.  In the event that the JPC is unable to reach consensus with respect to a particular matter within its purpose, then either Party may, by written notice to the other, refer the matter to the respective business head of each Party or their respective designee who is senior in rank and authority to such Party’s JPC representatives (the “Senior Executives”) for resolution by good faith discussions for a period of at least fifteen (15) Business Days.  In the event that the Senior Executives are unable to reach agreement with respect to such matter within such fifteen (15) Business Days, then Licensee shall have the final decision-making authority with respect to such matter, except in the event that such matter is reasonably possible to create a Material Impact in the Talon Territory (the “Material Impact Matters”) and Talon notifies Licensee during or before any referral of the matter to Senior Executives of each Party for resolution of Talon’s belief that such matter is a Material Impact Matter, in which case, Talon shall have the final decision-making authority.
2.4Authority.  The JPC shall perform its responsibilities under this Agreement based on the principles of prompt and diligent Development and Commercialization of the Product for use in the Field in the Licensee Territory, consistent with good pharmaceutical practices and commercially reasonable consideration of the optimal balance of maximizing long-term sale of the Product in the Licensee Territory.
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2.5Day-to-Day Responsibilities.  Each Party shall: (i) be responsible for day-to-day implementation and operation of the activities hereunder for which it has or is otherwise assigned responsibility under this Agreement, provided, that such implementation is not inconsistent with the express terms of this Agreement or the decisions of the JPC within the scope of their authority specified herein; and (ii) keep the other Party informed as to the progress of such activities as reasonably requested by the other Party and as otherwise determined by the JPC.
2.6JPC Participation; Discontinuation.  It is understood that Talon’s participation on the JPC shall be as a matter of right, but not an obligation.  Accordingly, Talon may, at its discretion, elect to discontinue its participation in the JPC at any time during the Term upon written notice to Licensee.  If Talon provides such written notice, then JPC shall have no further authority under this Agreement and shall cease to function, and thereafter decisions which were previously to be made by the JPC as set forth and contemplated in this Agreement shall be made solely by the Licensee in its reasonable discretion except that all decisions with respect to Material Impact Matters shall be made solely by Talon, and all of the rights and obligations of the Parties under this Agreement shall continue in full force and effect as rights and obligations directly between the Parties, including, without limitation, each Party’s obligations to provide and rights to receive results, data and other information generated from the other Party’s activities with respect to the Development of the Product for use in the Field.
ARTICLE 3
LICENSES AND EXCLUSIVITY
3.1Grant to Licensee.
3.1.1License.  Subject to and in accordance with the terms and conditions of this Agreement, Talon hereby grants to Licensee, during the Term, (i) an exclusive (even as to Talon and its Affiliates, except to the extent necessary to perform their obligations under this Agreement), irrevocable (except as set forth in Article 9), fully paid-up, royalty-free (except as set forth in Section 5.2.1), sublicenseable at any tier (in accordance with Section 3.1.2) license to use the Talon Know-How, and under the Talon Patents, to Commercialize (including to use, sale, offer for sale and import) the Product solely in the Licensee Territory and solely for use in the Field, subject to and in accordance with Section 4.3, and (ii) a non-exclusive, irrevocable (except as set forth in Article 9), fully paid-up, royalty-free, sublicenseable at any tier (in accordance with Section 3.1.2) license to use the Talon Know-How, and under the Talon Patents, to Develop the Product solely in the Licensee Territory and solely for use in the Field, subject to and in accordance with Sections 4.1 and 4.2.
3.1.2Sublicenses.  Neither Licensee nor any of its Affiliates may grant or authorize sublicenses under the license under Section 3.1.1 without the prior written consent of Talon, which approval shall not be unreasonably withheld, delayed, or conditioned, except that Licensee shall have the right to sublicense at any tier the license under Section 3.1.1 to its Affiliates without the consent of Talon.  Licensee shall be responsible for the failure by its Affiliates to comply with, and Licensee shall ensure the compliance by each of its Affiliates with, the terms of this Agreement including all relevant restrictions, limitations and obligations.
3.2Activities Outside the Field and Outside the Licensee Territory.
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3.2.1Licensee Rights Limited to the Field and the Licensee Territory.  Licensee agrees that neither it, nor any of its Affiliates, will Develop (including file for Regulatory Approval with respect to) or Commercialize (including use, sale, offer for sale or import) the Product anywhere in the world, or for any use anywhere in the world, except in the Licensee Territory, and for use in the Field in the Licensee Territory, only in accordance with and under this Agreement.  Licensee agrees that neither it, nor any of its Affiliates, will use or otherwise exploit, except as expressly licensed under this Agreement, any Talon Patents, Talon Know-How and/or Talon Trademark, or their counterparts in a country outside the Licensee Territory.
3.2.2Territorial Integrity.  Each Party shall use Commercially Reasonable Efforts to prevent any Product sold or otherwise distributed by such Party, directly or indirectly, from being sold, distributed or otherwise transported for use outside its respective Territory.
3.3Upstream Licenses.  In addition to the payment obligations under Section 5.2, Licensee shall, and shall cause its Affiliates and sublicensees to, comply with all the terms and conditions of the Upstream Licenses applicable to Licensee or its Affiliates or sublicensees, or to Talon due to Licensee’s or its Affiliates’ or sublicensees’ activities, under this Agreement in the Licensee Territory.  To the extent that any provisions are more restrictive, or broader, under the Upstream Licenses than may be explicitly set out in the Agreement, such more restrictive or broader provisions shall govern Licensee’s rights.  During the Term, Talon shall promptly furnish Licensee with copies of (a) complete and unredacted copies of the Upstream Licenses and any relevant ancillary agreements, exhibits, schedules, or other documents which set forth and are sufficient to fully describe all the terms and conditions with which Licensee must comply in relation to the Upstream Licenses, (b) all amendments of the Upstream Licenses, and (c) all correspondence (or in the case of oral discussions, a summary of such discussions) with or from and reports received from or provided to licensors under the Upstream Licenses to the extent material to Licensee or the rights granted or to be granted to Licensee under this Agreement.  In addition, during the Term, Talon shall provide copies of all notices received by Talon relating to any alleged breach or default by Talon under the Upstream Licenses within five (5) Business Days after Talon’s receipt thereof.
3.4Assistance to Obtain Rights to Additional Products.
3.4.1Introduction to Third Parties with Rights to Additional Products.  With regard to any current and/or future proprietary, licensed or acquired pharmaceutical or biologic assets or products, and any and all other derivatives, and/or improvements thereof, that Talon Controls or that come under the Control of Talon, other than the Product (the “Additional Products”), to the extent Development and Commercialization rights in the Licensee Territory are Controlled by Third Parties, at Licensee’s reasonable request, Talon shall use good faith efforts, solely from the perspective of Talon’s best interests, to introduce Licensee to such Third Parties to facilitate Licensee to license or acquire such rights in the Licensee Territory from such Third Parties, with the understanding that Licensee shall be solely responsible for all costs or consideration related to a license or acquisition of such rights in the Licensee Territory from such Third Parties.
3.4.2Efforts to Obtain Rights in the Licensee Territory. Talon shall use good faith efforts, solely from the perspective of Talon’s best interests, when engaging in negotiations with Third Parties to license or acquire any Development and Commercialization rights for any pharmaceutical
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or biologic assets or products, and any and all other derivatives, and/or improvements thereof owned by such third parties, to license or acquire Development and Commercialization rights thereto in the Licensee Territory.
3.4.3Termination Upon Change of Control.  Licensee acknowledges and agrees that Talon’s obligations under Sections 3.4.1 and 3.4.2 above shall terminate and be of no further effect upon the consummation of Change of Control by Talon.
3.5No Other Rights.  Each Party acknowledges that the rights and licenses granted under this Article 3 and elsewhere in this Agreement are limited to the scope expressly granted.  Accordingly, except for the rights expressly granted under this Agreement, no right, title, or interest of any nature whatsoever is granted, whether by implication, estoppel, reliance, or otherwise, by either Party to the other Party.  All rights with respect to Know-How, Patents or other Intellectual Property rights that are not specifically granted herein are reserved to the owner thereof.
ARTICLE 4
REGULATORY MATTERS, DEVELOPMENT AND COMMERCIALIZATION OF PRODUCT
4.1Regulatory Matters.
4.1.1General.  Licensee shall be responsible for all correspondence, meetings and other interactions, with the relevant Regulatory Authorities concerning regulatory activities related to the Product in the Field in the Licensee Territory, and for preparing and filing any and all Regulatory Filings for Regulatory Approval for the Product in the Field in the Licensee Territory at its sole expense and shall use Commercially Reasonable Efforts in doing so.  Talon shall assist and cooperate with Licensee in connection with the preparation, filing and maintenance of such Regulatory Filings, as reasonably requested by Licensee.  All Regulatory Approvals in the Licensee Territory shall be owned by Licensee and filed and obtained in Licensee’s and/or Talon’s name in accordance with Applicable Laws.
4.1.2Reporting.  Licensee shall keep Talon fully informed of regulatory developments relating to the Product in the Field in the Licensee Territory and shall promptly notify Talon in writing of any action or decision by any Regulatory Authority in the Licensee Territory regarding the Product in the Field.  Licensee shall provide Talon for review and comment all draft Regulatory Filings in its original language (with a summary in English) and in electronic form (other than routine correspondence) at least twenty (20) Business Days (or in the event of a shorter filing deadline, as soon as practicable) in advance of their intended date of submission to a Regulatory Authority in the Licensee Territory.  Talon shall use good faith efforts to provide Licensee with comments to such draft Regulatory Filings prior to the intended date of submission, and Licensee shall consider in good faith any comments thereto provided by Talon.  Licensee shall promptly notify Talon of any Regulatory Filings (other than routine correspondence) submitted to or received from any Regulatory Authority in the Licensee Territory regarding the Product in the Field, and shall provide copies thereof at least five (5) Business Days after submission or receipt, which copy may be provided in its original language and in electronic form.  Licensee shall keep Talon informed of all meetings, conferences and discussions with any Regulatory Authority in the Licensee Territory concerning the
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Product, and shall provide Talon with a summary of the substantive content discussed in any such meeting, conferences or discussions within five (5) Business Days after  such meetings, conferences or discussions.  In addition, upon Talon’s request, Licensee shall promptly meet and confer with Talon to discuss any regulatory matters related to the Product in the Licensee Territory, either in person at Licensee’s facility or by audio or video teleconference as Talon may elect.
4.1.3Regulatory Costs.  Licensee shall be solely responsible for all of its costs and expenses related to the preparation, filing and maintenance of all Regulatory Approvals for the Product in the Field in the Licensee Territory.  Talon shall support Licensee, as reasonably requested by Licensee, in obtaining Regulatory Approvals in Licensee Territory, including providing necessary documents or other materials in Talon’s possession required by Applicable Laws to obtain Regulatory Approvals in such territory, all in accordance with the terms and conditions of this Agreement, provided, that Talon shall be under no obligation to generate any additional data unless specifically agreed by Talon and Licensee.
4.1.4Rights of Reference.  Talon hereby grants to Licensee a right of reference to all Regulatory Filings filed by or on behalf of Talon, which right of reference Licensee may use for the sole purpose of seeking, obtaining and maintaining Regulatory Approvals and Developing and Commercializing the Product in the Field in the Licensee Territory.  At Licensee’s reasonable request, Talon shall submit to the Regulatory Authorities a copy of the Regulatory Filings related to the Product, which are reasonably determined by Talon to be necessary to support Licensee’s application for Regulatory Approvals in the Licensee Territory.
4.1.5Reporting; Adverse Drug Reactions.
(a)Pharmacovigilance Agreement.  Promptly after the Effective Date, the Parties shall enter into a pharmacovigilance agreement on reasonable and customary terms, including:  (a) providing detailed procedures regarding the maintenance of core safety information and the exchange of safety data relating to the Product within appropriate timeframes and in an appropriate format to enable each Party to meet both expedited and periodic regulatory reporting requirements; and (b) ensuring compliance with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis for the reporting of safety data in accordance with all applicable regulatory and legal requirements regarding the management of safety data.  Each Party hereby agrees to comply with its respective obligations under such pharmacovigilance agreement and to cause its Affiliates to comply with such obligations.
(b)Adverse Event Reporting.  As between the Parties: (a) Licensee or its designee shall be responsible for the timely reporting of all adverse drug reactions/experiences, Product quality, Product complaints and safety data relating to the Product to the appropriate Regulatory Authorities in the Licensee Territory; and (b) Talon or its designee shall be responsible for reporting all adverse drug reactions/experiences, Product quality, Product complaints and safety data relating to the Product to the appropriate Regulatory Authorities in the Talon Territory; all in accordance with Applicable Laws.
4.1.6Talon Assistance for Imported Products.  In the event that (a) to apply for Regulatory Approval for the Product as an imported drug or product (an “Imported Product
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Regulatory Approval”) in a country or regulatory jurisdiction within the Licensee Territory, a Regulatory Authority or Applicable Laws of such country or regulatory jurisdiction requires the applicant to hold a marketing authorization, certificate of pharmaceutical product, or an equivalent certification for such Product outside of such country or regulatory jurisdiction within the Licensee Territory (a “Foreign Marketing Approval”), (b) Licensee decides to seek Imported Product Regulatory Approval for such Product in such country or regulatory jurisdiction, and (c) Licensee requests Talon, if Talon is the Foreign Marketing Approval holder for such Product, to authorize Licensee to file, in Talon’s name, or if, Talon’s Affiliate or a Third Party is the Foreign Marketing Approval holder for such Product (the “Non-Talon Foreign Marketing Approval Holder”), to procure such Non-Talon Foreign Marketing Approval Holder to authorize Licensee to file in such Non-Talon Foreign Marketing Approval Holder’s name, for such Imported Product Regulatory Approval for such Product, then, Talon shall, and shall use commercially reasonable efforts to cause any Non-Talon Marketing Approval Holder to, provide all reasonable assistance, facilitation and support including providing all documents and data reasonably requested by Licensee in a timely manner and at Licensee’s cost to effectuate such Imported Product Regulatory Approval including:
(a)Licensee shall have sole responsibility for, and sole decision-making authority with respect to, preparing, filing, obtaining and maintaining the Imported Product Regulatory Approvals and related Regulatory Filings, provided, that Talon shall, and shall cause its Affiliates and any Non-Talon Foreign Marketing Approval Holder to, at the request of Licensee, cooperate with Licensee to prepare, file, obtain and maintain such Imported Product Regulatory Approvals and related Regulatory Submissions.
(b)Talon shall:
(i)if Talon holds the Foreign Marketing Approval, authorize Licensee, and provide all reasonable assistance, facilitation and support including providing all documentations and data reasonably requested by Licensee to Licensee, to file, in Talon’s name, for Imported Product Regulatory Approval in such country or regulatory jurisdiction, at the direction of Licensee and for Licensee’s sole benefit; or
(ii)if a Non-Talon Foreign Marketing Approval Holder holds the Foreign Marketing Approval for such Product, use commercially reasonable efforts to cause such Non-Talon Foreign Marketing Approval Holder to authorize and provide all reasonable assistance, facilitation and support including providing all documentations and data reasonably requested by Licensee to Licensee, to file, in such Non-Talon Foreign Marketing Approval Holder’s name, for Imported Product Regulatory Approval in such country or regulatory jurisdiction, at the direction of Licensee and for Licensee’s sole benefit.
(c)If the Regulatory Authority or Applicable Laws in such country or regulatory jurisdiction allows the  Talon to appoint a local agent (or registration agent) to assist in the filing, maintenance or amendment of the Imported Product Regulatory Approval, then Talon shall appoint, or use commercially reasonable efforts to procure any Non-Talon Foreign Marketing Approval Holder to appoint, including providing a power of attorney which effectuates such appointment and registering such appointment with the relevant Regulatory Authority, Licensee or its designated Affiliate as its designated local agent for the Imported Product Regulatory Approval
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process inclusive of, to the fullest extent possible, the receipt of communications from the Regulatory Authority and submission of all relevant Regulatory Submissions.
(d)Talon shall use commercially reasonable efforts to cause any Non-Talon Foreign Marketing Approval Holder to grant to Licensee, during the Term, an exclusive (even as to Talon, its Affiliates, and any Non-Talon Foreign Marketing Approval Holder), irrevocable (except as set forth in Article 9), fully-paid, royalty-free (except as set forth in Section 5.2.1), sublicenseable (in accordance with Section 3.1.2) license under such Imported Product Regulatory Approvals to Develop and Commercialize the Product solely in the Licensee Territory and solely for use in the Field in accordance with this Agreement. In addition, Talon shall cause any Non-Talon Foreign Marketing Approval Holder to, provide to Licensee, all benefits of any Imported Product Regulatory Approvals and enforce, at Licensee’s cost and expense, at the request of and for the account of Licensee, any rights of Talon or its Affiliates arising under any Imported Product Regulatory Approvals against any Person.
(e)Talon shall use commercially reasonable efforts to cause any Non-Talon Foreign Regulatory Approval Holder to Manufacture and supply via the named manufacturer or supplier on the relevant Imported Product Regulatory Approval all Products for Commercialization under the Imported Product Regulatory Approvals in the Territory to Licensee and its designated Affiliates and sublicensees at a price per Product equal to the Non-Talon Foreign Regulatory Approval Holder’s Manufacturing Cost (as may change from time to time) for such Product plus [***].
(f)Talon shall, and hereby appoints, and shall use commercially reasonable efforts to cause its Affiliates and any Non-Talon Foreign Marketing Approval Holder to appoint, Licensee as its attorney-in-fact to Develop and Commercialize the Product under the Imported Product Regulatory Approval on Talon’s or the Non-Talon Foreign Marketing Approval Holder’s behalf, and shall execute a power of attorney in favor of Licensee to this effect during the Term.
(g)Talon shall, and shall use commercially reasonable efforts to cause its Affiliates and any Non-Talon Foreign Marketing Approval Holder to, (x) notify Licensee of all communications received from the applicable Regulatory Authority with respect to any Imported Product Regulatory Approvals, (y) provide all official original copies of all Imported Product Regulatory Approvals received from the applicable Regulatory Authority to Licensee, and (z) provide copies of any written correspondence received from the applicable Regulatory Authorities with respect to any Imported Product Regulatory Approvals to Licensee, in each case, promptly after receipt thereof.
(h)Talon shall not, and shall use commercially reasonable efforts to cause its Affiliates and any Non-Talon Foreign Marketing Approval Holder to not, interact or communicate with the CFDA regarding the Imported Product Regulatory Approvals without the prior approval or participation of Licensee.
(i)If at any time Talon, its Affiliates or any Non-Talon Foreign Marketing Approval Holder are permitted by the applicable Regulatory Authority to transfer the Imported Product Regulatory Approval to Licensee, Talon shall, and hereby does, and shall cause its Affiliates and any Non-Talon Foreign Marketing Approval Holder to, assign to Licensee or its designated
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Affiliate, all rights, title and interests in and to such Imported Product Regulatory Approvals and related Regulatory Submissions for the Product in the Field in the Territory.  Talon agrees and covenants that it shall, and shall cause it Affiliates and any Non-Talon Foreign Marketing Approval Holder to, promptly take any and all actions necessary to effectuate the prompt assignment of such Imported Product Regulatory Approvals and related Regulatory Submissions, or to enable Licensee or its designated Affiliate to obtain new Imported Product Regulatory Approvals or related Regulatory Submissions, including executing and delivering all documents or instruments, and providing all copies of documents or information, that may be necessary, required or which Licensee or its designated Affiliate may request.
4.2Development.
4.2.1General.  Licensee shall take the lead in, and be responsible for, conducting the Development activities, including clinical trials, as may be reasonably necessary to expeditiously obtain Regulatory Approvals for the Product for use in the Field in the Licensee Territory.  Except as otherwise provided herein, it is understood and agreed that, as between the Parties, all Development efforts for the Product for use in the Field in the Licensee Territory shall be at the sole expense of Licensee.
4.2.2Clinical Trials.  If additional clinical trials are required in the Licensee Territory, Licensee shall promptly inform JPC and shall not conduct any clinical trial without the prior approval of the JPC in accordance with Section 2.3.
4.2.3Development Assistance. Promptly after the Effective Date, but not to exceed thirty (30) days following the Effective Date, Talon shall, at its own cost and expense, make available to Licensee the Talon Know-How that exists on the Effective Date and was not previously provided to Licensee (but without an obligation for Talon personnel to travel) including all Talon Know-How developed, collected, or submitted as part of an investigational new drug application or similar application or submission filed with or submitted to any Regulatory Authority to obtain permission to commence clinical trials in relation to the Product in any particular jurisdiction (the “Initial Transfer”).  For clarity, the Initial Transfer shall not require Talon to conduct any new Development work or prepare or complete any reports not already completed.  After the Initial Transfer, Talon shall provide Licensee with reasonable assistance regarding scientific, clinical and/or manufacturing matters (including the chemistry, manufacture and controls of the Product) in the Development of the Product in the Field in the Licensee Territory.  Such assistance shall include the transfer of additional Talon Know How to Licensee and reasonable access to Talon personnel involved in the research and Development of the Product, either in-person or by teleconference.
4.2.4Diligence.  Licensee shall use Commercially Reasonable Efforts to Develop and obtain and maintain Regulatory Approval for the Product for at least one indication in the Field in the Licensee Territory and shall not take actions that would be reasonably likely to create a Material Impact.  Licensee will have no other diligence obligations with respect to the Development of the Product under this Agreement.
4.3Commercialization.
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4.3.1General.  Except as otherwise provided herein, it is understood and agreed that, as between the Parties, all Commercialization efforts for the Product for use in the Field in the Licensee Territory shall be at the sole expense of Licensee.
4.3.2Diligence.  Licensee will use Commercially Reasonable Efforts to Commercialize the Product in the Field in each country in the Licensee Territory in which Regulatory Approval is received and shall not take actions that would be reasonably likely to create a Material Impact.  Without limiting the foregoing, Licensee agrees to, directly or through one or more of its Affiliates, use Commercially Reasonable Efforts (i) to launch the Product for use in the Field as soon as practicable in the Licensee Territory, and thereafter (ii) to market, promote and sell the Product in the Field throughout the Licensee Territory to maximize Net Sales with respect thereto.  Licensee will have no other diligence obligations with respect to the Commercialization of the Product under this Agreement.
4.3.3Pricing.  Licensee shall have the sole right to determine pricing of the Product in the Field in the Licensee Territory, provided, that Licensee and Talon shall discuss the pricing strategy for the Licensee Territory.
4.3.4Trademarks.
(a)Licensee Trademarks.  Licensee shall have the right to select the Product names and all trademarks, including any Talon Trademarks (subject to Section 4.3.4(b) and only to the extent Talon has the right to grant a license to such Talon Trademarks to Licensee), used in connection with the Commercialization of the Product for use in the Field, including special promotional or advertising taglines, in each case in the Licensee Territory (all such trademarks, other than the Talon Trademarks, specific to the Product and including all goodwill associated therewith, and all applications, registrations, extensions and renewals relating thereto, shall be referred to as the “Licensee Trademarks”).  Licensee shall be the exclusive owner of the Licensee Trademarks, and shall use Commercially Reasonable Efforts to register and maintain, at its expense, such Licensee Trademarks as shall be used for Commercialization of the Product for use in the Field in the Licensee Territory.
(b)Reference to Talon as Licensor.
(i)Talon Trademarks.  To the extent permitted by Applicable Laws, at Talon’s election, the labels and packaging of the Product and all promotional materials for the Product shall include text identifying Talon as the licensor of the Product and a Talon Trademark to be placed in a size and location reasonably agreed to by the Parties, provided, that such mark: (i) is used in a consistent and noticeable manner sufficient to constitute trademark usage under Applicable Laws, (ii) is clearly identified as a trademark (i.e., through the use of a “®”, “TM” or other appropriate identifier), (iii) is not used as combination marks with other marks or trademarks, and (iv) is reasonably less prominent in size and location as the Licensee Trademarks.  Licensee shall obtain Talon’s review and approval prior to the first use of the Talon Trademarks in such labeling, packaging or promotional materials, such approval not to be unreasonably withheld if the Talon Trademarks are used in a manner that is consistent with Talon’s reasonable usage guidelines for such Talon Trademarks.
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(ii)Trademark License.  In connection with Section 4.3.4(b)(i) above, Talon hereby grants to Licensee an exclusive license to use the Talon Trademarks (except with respect to the Talon’s trade name under which such license to use is non-exclusive) for the packaging, labeling, marketing, promotion, distribution and sale of the Product for use in the Field in the Licensee Territory in accordance with this Agreement, and Licensee shall have the right to exercise such license through its Affiliates, provided, that Licensee shall be responsible for the failure by its Affiliates to comply with, and Licensee guarantees the compliance by each of its Affiliates with, the terms of this Agreement including all relevant restrictions, limitations and obligations.  Talon shall own all right, title and interest in and to the Talon Trademarks and the registrations thereof and all goodwill from the use of the Talon Trademarks shall vest in and inure to the benefit of Talon.  Talon shall use Commercially Reasonable Efforts to register and maintain, at Licensee’s expense, such Talon Trademarks as shall be used for Commercialization of the Product for use in the Field in the Licensee Territory.
(c)Talon Product Marks.  Talon shall have the right, but not the obligation, to brand the Product for use in the Field in the Talon Territory using the Licensee Trademarks (“Talon Product Marks”).  Accordingly, Licensee shall provide to Talon copy proofs of each Licensee Trademark and reasonable usage guidelines therefor as such mark is registered with the applicable Regulatory Authorities in the Licensee Territory for Talon’s review and consideration.  Talon shall obtain Licensee’s review and approval prior to the first use of the Talon Product Marks in such labeling, packaging or promotional materials, such approval not to be unreasonably withheld if the Talon Product Marks are used in a manner that is consistent with Licensee’s reasonable usage guidelines for such Talon Product Marks.  Subject to this Section 4.3.4(c), Licensee further hereby grants to Talon an exclusive license to use the Talon Product Marks (except with respect to the Licensee’s trade name under which such license to use is non-exclusive), to the extent Talon Product Marks exist in the Talon Territory, consistent with the usage guidelines applicable to Licensee and its Affiliates’ use of such Licensee Trademarks in the Licensee Territory solely in connection with the Development and Commercialization of the Product solely for use in the Field and solely in the Talon Territory for the packaging, labeling, marketing, promotion, distribution and sale of the Product for use in the Field in the Talon Territory in accordance with this Agreement, and Talon shall have the right to exercise such license through its Affiliates or sublicense a Third Party, provided, that Talon shall be responsible for the failure by its Affiliates or Third Party sub-licensees to comply with, and Talon guarantees the compliance by each of its Affiliates with, the terms of this Agreement including all relevant restrictions, limitations and obligations.  Licensee shall own all right, title and interest in and to any Talon Product Marks and the registrations thereof and all goodwill from the use of the Talon Product Marks shall vest in and inure to the benefit of Licensee.  The above notwithstanding, Licensee shall have the right, but not the obligation, to register or maintain any Talon Product Marks in the Talon Territory.
4.4Reporting.  Without limiting any other provisions of this Agreement, Licensee shall keep Talon reasonably informed through the JPC as to the progress of its activities with respect to the Development and Commercialization of the Product or otherwise under this Article 4 and provide such reports and information with respect thereto as designated by the JPC or as may be reasonably requested by Talon.  In addition, Licensee shall promptly notify Talon if it anticipates or there are material deviations from the Commercialization Plan(s) or any development diligence requirement,
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and shall discuss in good faith and keep Talon informed as to any corrective actions that it intends or is taking to address such deviations.
4.5Manufacturing and Supply.
4.5.1No Manufacturing Rights.  Talon retains all rights with respect to manufacturing of the Product.
4.5.2Supply.  Subject to the terms and conditions of this Agreement, Talon shall use Commercially Reasonable Efforts to supply or have supplied to Licensee or its designee all quantities of the Product ordered by Licensee for use in the Field in the Licensee Territory in accordance with a separate written agreement to be negotiated between the Parties pursuant to Section 4.5.3 below (a “Supply Agreement”).  Licensee shall solely purchase from Talon its entire requirement of the Product and Talon shall have the right to manufacture and have manufactured such quantities of the Product for Licensee.
4.5.3Supply Agreement.  Within ninety (90) days of the Effective Date, the Parties shall negotiate and execute a Supply Agreement for the supply by Talon to Licensee of the requirements of the Product ordered by Licensee for Development and Commercialization in the Licensee Territory.
4.5.4Supply Price and Adjustment. The price per unit of each Product supplied by Talon under the Supply Agreement shall be equal to Talon’s Manufacturing Cost (as may change from time to time) for such Product plus [***].
4.5.5Quality Agreement.  Within ninety (90) days of executing the Supply Agreement, Talon and Licensee shall execute a mutually acceptable quality agreement that allocates roles and responsibilities to each Party with respect to quality control and regulatory compliance with respect to supply of the Product to Licensee.
ARTICLE 5
PAYMENTS
5.1Upfront Payment.  As consideration for the licenses granted under Section 3.1 and Licensee’s other rights under this Agreement, Licensee shall pay to Talon one million five hundred thousand U.S. dollars (USD$1,500,000) by delivery of a secured promissory note in the form of Exhibit 5.1 (the “Upfront Note”).
5.2Payments to Upstream Licensors.
5.2.1Payments.  Licensee shall pay to Talon any and all payments due from Talon to Tekmira or the Rights Agent under the Upstream Licenses on account of the Development and/or Commercialization of the Product in the Field in the Licensee Territory by Licensee and its Affiliates and sublicensees (the “Upstream Payments”) including running royalty payments; provided that if Licensee is obligated to make any Upstream Payments due to the achievement of a milestone, Licensee shall only pay: (a) a prorated portion of any Upstream Payments triggered by the occurrence of a sales milestones reached in part due to sales by Licensee in the Licensee Territory; and (b) any Upstream
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Payments triggered by the occurrence of a development milestone wherein the trigger is explicitly defined as the achievement of a milestone in the Licensee Territory or achieved as a direct result of Licensee’s Development of the Product in the Licensee Territory.  As an example of Licensee’s obligation to only pay a prorated portion of an Upstream Payment triggered by the occurrence of a sales milestone, if (x) a sales milestone payment of $10,000,000 is triggered due to the occurrence of aggregate annual sales of the Product within a territory covering the Licensed Territory reaching a certain threshold and (y) at the triggering of the sales milestone payment, Licensee’s annual sales of the Product in the Licensee Territory for the year the payment is triggered account for 10% of total sales of the Product in a territory which covers the Licensee Territory, then (z) Licensee shall pay $1,000,000 of that $10,000,000 sales milestone payment. Except for (i) the upfront payment under Section 5.1, and (ii) the Upstream Payments under this Section 5.2.1, no payment shall be due from Licensee to Talon for the Development and/or Commercialization of the Product in the Field in the Licensee Territory.
5.2.2Payment Reports and Payments.  For as long as Licensee is obligated to make the Upstream Payments in accordance with Section 5.2.1, within twenty five (25) days after the last day of each calendar quarter, Licensee will deliver to Talon a report of Net Sales of the Product by Licensee, its Affiliates and sublicensees during the preceding quarterly period (any such period, a “Payment Period”), with all the Upstream Payments in accordance with Section 5.2.1, if any, for the Payment Period covered by such report being due no later than forty (40) days after the last day of such Payment Period. For any Upstream Payments triggered due to the occurrence of a sales milestone, Talon shall provide Licensee with an invoice no later than twenty (20) days before such Upstream Payment is due if feasible or such other documentation and such invoice or documentation will set forth: (a) the Licensee’s prorated portion of such Upstream Payment, (b) how the Licensee’s prorated portion of the Upstream Payment was calculated and reasonable support for the calculation, and (c) the date when such Upstream Payment is due.   In relation to any Upstream Payment, which Talon claims is triggered due to the occurrence of a development milestone achieved as a direct result of Licensee’s Development of the Product in the Licensee Territory (other than wherein the trigger is explicitly defined as the achievement of a milestone in the Licensee Territory), Talon shall provide Licensee with information, reasonably requested by Licensee, regarding the Development of the Product in the Talon Territory sufficient for Licensee to determine whether Licensee’s Development has triggered such an Upstream Payment.
5.3Payment Method.  All payments due under this Agreement to Talon shall be made by bank wire transfer in immediately available funds to an account designated by Talon.  All payments hereunder shall be made in the legal currency of the United States of America, and all references to “$” or “Dollars” shall refer to United States dollars.  To the extent that Applicable Law imposes withholding taxes on any payments from Licensee to Talon pursuant to this Agreement, Licensee may withhold such taxes and pay such amounts  to the relevant government authority.  For any Upstream Payments where Talon cannot reduce any amounts owed to the Upstream Licensor under the applicable Upstream License with respect to withholding taxes paid by the Licensee under this Agreement, all amounts payable to Talon pursuant to this Agreement shall be made without reduction for any withholding or similar taxes paid by Licensee.  For any Upstream Payments where Talon can reduce any amounts owed to the Upstream Licensor under the applicable Upstream License with respect to withholding taxes paid by the Licensee under this Agreement, the Licensee may deduct from the amounts payable to Talon pursuant to this Agreement any withholding or similar taxes paid by
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Licensee.  Licensee shall furnish to Talon appropriate evidence of payment of such taxes or other amount required by Applicable Laws to be deducted from any payment due under this Agreement to Talon, including any tax or withholding levied by a foreign taxing authority in respect of such payment.
5.4Support Fees.  Talon will provide to Licensee at its own expense: (a) [***] ([***]) hours of regulatory and development support during the first Agreement Year, and (b) [***] ([***]) hours of regulatory and development support for each Agreement year after the first anniversary of the Effective Date.  Regulatory and development support provided by Talon to Licensee, in excess of the number of free hours, set forth above, in any Agreement Year, shall be charged at a rate of $[***] per hour. For clarity, the costs incurred by Talon to provide the Initial Transfer under Section 4.2.3 shall also be borne by Talon and shall not be charged to Licensee or counted toward the hours set out in the this Section that Talon will provide to Licensee at its own expense.
5.5Records; Audit.  The Parties will, and will cause its Affiliates to, keep and maintain for three (3) years after the relevant calendar quarter complete and accurate books and records in sufficient detail so that Net Sales and payments made hereunder can be properly calculated.  No more frequently than once during each calendar year during the Term and once during the three (3) year period thereafter, the Parties will permit independent third party auditors appointed by Talon, Talon, Tekmira or Licensee (the party requesting an audit, the “Auditing Party”) and with at least forty-five (45) days advance notice at any time during normal business hours, accompanied at all times, to inspect, audit and copy reasonable amounts of relevant accounts and records of the non-Auditing Party and its Affiliates and reports submitted to the non-Auditing Party and its Affiliates by its sublicensees pertaining to a payment period that is not earlier than thirty-six (36) months from the date of conclusion of the audit, for the sole purpose of verifying the accuracy of the calculation of Upstream Payments to Talon pursuant to this Article 5.  The accounts, records and reports related to any particular period of time may only be audited one time under this Section 5.5.  The Auditing Party will cause their independent third party auditors not to provide the Auditing Party with any copies of such accounts, records or reports and not to disclose to the Auditing Party any information other than information relating solely to the accuracy of the accounting and payments made by Licensee pursuant to this Article 5.  The Auditing Party will cause its independent third party auditors to promptly provide a copy of their report to non-Auditing Party.  If such audit determines that payments are due to Talon, Licensee will pay to Talon any such additional amounts within ten (10) Business Days after the date on which such auditor’s written report is delivered to Licensee and the Auditing Party, unless such audit report is disputed by Licensee, in which case the dispute will be resolved in accordance with Article 10.  If such audit determines that Licensee has overpaid any amounts to Talon, Talon will refund any such overpaid amounts to Licensee within ten (10) Business Days after the date on which such auditor’s written report is delivered to Licensee and the Auditing Party.  Any such inspection of records will be at the Auditing Party’s expense unless such audit discloses a deficiency or overpayment in the payments made by Licensee (whether for itself or on behalf of its Affiliates) of more than [***] percent ([***]%) of the aggregate amount payable for the relevant period, in the case of such a deficiency, Licensee will bear the cost of such audit, or in the case of such overpayment caused by Talon, Talon shall bear the cost of such audit. Each of the parties agree that all information subject to review under this Section 5.5 is non-Auditing Party’s Confidential Information that is subject to  confidentiality and non-use obligations under Section 7.2, and Auditing Party agrees that it shall cause its independent third party auditors to also retain all such information subject to the non-disclosure
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and non-use restrictions of Section 7.2 or similar (but no less stringent) obligations of confidentiality and non-use customary in the accounting industry.
5.6Late Payment.  Any payments or portions thereof due hereunder which are not paid when due shall bear interest equal to the lesser of (i) the rate equal to the thirty (30) day U.S. dollar LIBOR rate effective for the date that payment was due, as published by The Wall Street Journal, Internet Edition at www.wsj.com in the “Money Rates” column, on the date such payment was due, plus an additional [***] percent ([***]%), or (ii) the maximum rate permitted by Applicable Laws, calculated on the number of days such payment is delinquent.  This Section 5.6 shall in no way limit any other remedies available to Talon.
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ARTICLE 6
INTELLECTUAL PROPERTY
6.1Ownership of Inventions.
6.1.1Ownership.
(a)Talon shall own all right, title and interest to (i) any and all Inventions solely Made by or on behalf of Talon or its Affiliates in connection with their activities under this Agreement and (ii) any and all Patents claiming any such Inventions described in the foregoing clause (ii) (collectively, “Talon Inventions”).
(b)Licensee shall own all right, title and interest to (i) any and all Inventions solely Made by or on behalf of Licensee or its Affiliates or sublicensees in connection with their activities under this Agreement, and (ii) any and all Patents claiming any such Inventions described in the foregoing clause (i) (collectively, “Licensee Inventions”).
(c)The Parties shall jointly own all right, title and interest to (i) any and all Inventions jointly Made by at least one employee, agent, consultant, contractor, Affiliate, or sublicensee of Talon and at least one employee, agent, consultant, contractor, Affiliate, or sublicensee of Licensee (each having the obligation to assign such Inventions to either Talon or Licensee), and (ii) any and all Patents claiming such Inventions described in the foregoing clause (i) (“Joint Patents” and collectively with Inventions described in clause (i), “Joint Inventions”).
(d)During the Term, Talon Inventions and Joint Inventions shall be included in the definition of Talon Technology, Talon Patents, Talon Know-How, and Talon Copyrights, as applicable, and subject to the licenses granted under Section 3.1.  For the avoidance of doubt, Talon reserves the right to use, practice or otherwise exploit any and all Talon Inventions and Joint Inventions subject to the licenses granted under Section 3.1.
6.1.2Interpretation.  For purposes of this Section 6.1, “Invention” shall mean any invention (whether or not patentable), data, results, ideas, discovery, development, method, process, know-how, works of authorship or other information that is Made by or on behalf of a Party or the Parties; and “Made” shall mean developed, conceived, authored, acquired or created by or on behalf of a Party or the Parties.  It is understood that except as expressly set forth under this Section 6.1, inventorship, authorship and other indicia of which Party Made an Invention will be determined in accordance with United States or the relevant foreign Intellectual Property laws under which the relevant foreign Intellectual Property right exists in effect at the time such Invention was Made.
6.2License Grant to Talon.  Licensee hereby grants to Talon a perpetual, irrevocable, fully paid-up, royalty free, exclusive license, with the right to grant sublicenses at any tier, under Licensee Know-How (including, without limitation, Licensee Inventions) and Licensee’s rights in the Joint Inventions, to research, Develop, make, have made, use, sell, offer for sale, have sold, import and otherwise Commercialize the Product in the Talon Territory.
6.3Patent Prosecution.  Talon shall control the Prosecution and Maintenance of Talon Patents and Joint Patents.  Licensee will bear the costs of Prosecution and Maintenance of all Talon
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Patents and Joint Patents in the Licensee Territory.  Costs billed to or incurred by Talon for the Prosecution and Maintenance of all Talon Patents and Joint Patents in the Licensee Territory will be rebilled to Licensee and are due within thirty (30) days of rebilling by Talon.
6.4Defense of Third Party Infringement Claims.  If the Product becomes the subject of a Third Party’s claim or assertion of infringement of a Patent relating to the manufacture, use, sale, offer for sale or importation of the Product for use in the Field in the Licensee Territory, the Party first having notice of the claim or assertion shall promptly notify the other Party, and the Parties shall agree on and enter into a “common interest agreement” wherein such Parties agree to their shared, mutual interest in the outcome of such potential dispute, and thereafter, the Parties shall promptly confer to consider the claim or assertion and the appropriate course of action.
6.5Enforcement.
6.5.1Notice.  Licensee will promptly report in writing to Talon any (a) known or suspected third party infringement of any Talon Patents, Talon Trademarks, or Talon Copyrights, or (b) unauthorized use or misappropriation of any Talon Know-How or other Confidential Information by a Third Party of which it becomes aware, and will provide Talon with all available evidence supporting such infringement or unauthorized use or misappropriation.  Talon will promptly report in writing to Licensee any (a) known or suspected third party infringement of any Licensee Inventions, Licensee Trademarks, or Talon Product Marks, or (b) unauthorized use or misappropriation of any Licensee Know-How or other Confidential Information by a Third Party of which it becomes aware, and will provide Licensee with all available evidence supporting such infringement or unauthorized use or misappropriation.
6.5.2Right to Enforce Talon Patents, Talon Trademarks or Talon Copyrights.  Talon will have the first right, but not the obligation, to take any reasonable measures it deems appropriate to stop activities in the Licensee Territory infringing the Talon Patents, Talon Trademarks or Talon Copyrights or the use without proper authorization of any Talon Know-How, in each case in connection with a Third Party’s manufacture, use, sale, offering for sale, or importation of Product for use in the Field in the Licensee Territory, including initiating or prosecuting an infringement or other appropriate action against.  If Talon does not initiate any such measures within one hundred twenty (120) days of receiving written notice from Licensee of such activities (or within a reasonable shorter time period if a shorter period to take action is required by Applicable Laws to avoid the loss of legal rights), then Licensee will have the second right, but not the obligation, to take any reasonable measures it deems appropriate to stop such activities, provided, that, Licensee must coordinate and consult with Talon regarding such measures and will not take any measures, without the written permission of Talon, which permission will not be unreasonably withheld.  It shall be reasonable for Talon to withhold such permission if Talon reasonably believes such measures will affect the protection that any Talon-Controlled Intellectual Property affords Talon.  Licensee will have no right to settle any infringement or misappropriation Action under this Section 6.5.2 in a manner that diminishes the rights or interests of Talon without the express written consent of Talon.  In addition, Licensee will not settle any such action in a manner that admits the invalidity or unenforceability of any Talon-Controlled Intellectual Property without obtaining the prior written consent of Talon.
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6.5.3Right to Enforce Licensee Inventions, Licensee Trademarks or Talon Product Marks.  Licensee will have the first right, but not the obligation, to take any reasonable measures it deems appropriate to stop activities in the Talon Territory infringing the Licensee Inventions, Licensee Trademarks or Talon Product Marks or the use without proper authorization of any Licensee Know-How, in each case in connection with a Third Party’s manufacture, use, sale, offering for sale, or importation of Product for use in the Field in the Talon Territory, including initiating or prosecuting an infringement or other appropriate action against.  If Licensee does not initiate any such measures within one hundred twenty (120) days of receiving written notice from Talon of such activities (or within a reasonable shorter time period if a shorter period to take action is required by Applicable Laws to avoid the loss of legal rights), then Talon will have the second right, but not the obligation, to take any reasonable measures it deems appropriate to stop such activities, provided, that, Talon must coordinate and consult with Licensee regarding such measures and will not take any measures, without the written permission of Licensee, which permission will not be unreasonably withheld.  It shall be reasonable for Licensee to withhold such permission if Licensee reasonably believes such measures will affect the protection that any Licensee -Controlled Intellectual Property affords Licensee.  Talon will have no right to settle any infringement or misappropriation Action under this Section 6.5.3 in a manner that diminishes the rights or interests of Licensee without the express written consent of Licensee.  In addition, Talon will not settle any such action in a manner that admits the invalidity or unenforceability of any Licensee-Controlled Intellectual Property without obtaining the prior written consent of Licensee.
6.5.4Right to Enforce Joint Patents or Joint Inventions.  Talon will have the first right, but not the obligation, to take any reasonable measures it deems appropriate to stop activities in the Licensee Territory infringing the Joint Patents or Joint Inventions or the use without proper authorization of any Joint Invention, in each case in connection with a Third Party’s manufacture, use, sale, offering for sale, or importation of Product for use in the Field in the Territory, including initiating or prosecuting an infringement or other appropriate action against.  If Talon does not initiate any such measures within one hundred twenty (120) days of becoming aware of such activities (or within a reasonable shorter time period if a shorter period to take action is required by Applicable Laws to avoid the loss of legal rights), then Licensee will have the second right, but not the obligation, to take any reasonable measures it deems appropriate to stop such activities in the Licensee Territory, provided, that, Licensee must coordinate and consult with Talon regarding such measures and will not take any measures, without the written permission of Talon, which permission will not be unreasonably withheld.  Licensee will have no right to settle any infringement or misappropriation Action under this Section 6.5.4 in a manner that diminishes the rights or interests of Talon without the express written consent of Talon.  In addition, Licensee will not settle any such action in a manner that admits the invalidity or unenforceability of any Joint Patent or Joint Inventions without obtaining the prior written consent of Talon.
6.5.5Cooperation.  The Party commencing, controlling or defending any enforcement action under this Section 6.5 (the “Enforcing Party”) shall keep the other Party reasonably informed of the progress of such action, and such other Party shall have the right to participate with counsel of its own choice at its own expense.  In any event, the other Party shall reasonably cooperate with the Enforcing Party, including providing information and materials, at the Enforcing Party’s request and expense.
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6.5.6Recoveries.   Any recovery received as a result of any enforcement action to enforce any Intellectual Property pursuant to this Section 6.5 shall be used first to reimburse the Enforcing Party for the costs and expenses (including court, attorneys’ and professional fees) incurred in connection with such action, and the remainder of the recovery shall be shared as following:  (i) if the enforcement action is filed in the Enforcing Party’s territory, one hundred percent (100%) of such recovery shall be paid to the Enforcing Party, and (ii) if the enforcement action is not filed in the Enforcing Party’s territory, [***] percent ([***]%) of such recovery shall be paid to the Enforcing Party and [***] percent ([***]%) of such recovery shall be paid to the other Party.
6.5.7Patents Claiming Talon Inventions.  During the Term, Patents claiming Talon Inventions that are necessary or useful for the Development and Commercialization of the Product shall be deemed Talon Patents and the enforcement thereof shall be subject to Sections 6.5.1- 6.5.6 above.
6.6Patent Marking.  At Talon’s request, Licensee shall mark (or cause to be marked) the Product marketed and sold hereunder with appropriate Talon Patent numbers or indicia in accordance with Applicable Laws.
ARTICLE 7
CONFIDENTIALITY
7.1Confidentiality; Exceptions.  Except to the extent expressly authorized by this Agreement or otherwise agreed by the Parties in writing, the Parties agree that the receiving Party shall keep confidential and shall not publish or otherwise disclose or use for any purpose other than as provided for in this Agreement any confidential or proprietary information or materials furnished to it by the other Party pursuant to this Agreement (collectively, “Confidential Information”).  Notwithstanding the foregoing, Confidential Information shall not be deemed to include information or materials to the extent that it can be established by written documentation by the receiving Party that such information or material:
7.1.1was already known to or possessed by the receiving Party without any obligation of confidentiality, at the time of its disclosure to the receiving Party hereunder;
7.1.2was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party hereunder;
7.1.3became generally available to the public or otherwise part of the public domain after its disclosure hereunder other than through any act or omission of the receiving Party in breach of this Agreement;
7.1.4was independently developed by the receiving Party without use of or reference to the other Party’s Confidential Information as demonstrated by documented evidence prepared by the receiving Party contemporaneously with such independent development; or
7.1.5was disclosed to the receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the disclosing Party not to disclose such information to others.
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7.2Authorized Use and Disclosure.  Each Party may use and disclose Confidential Information of the other Party as follows: (i) under appropriate confidentiality provisions substantially equivalent to those in this Agreement in connection with the performance of its obligations or exercise of rights granted to such Party in this Agreement; (ii) to the extent such disclosure is reasonably necessary for the Prosecution and Maintenance of Patents (including applications therefor) in accordance with this Agreement, prosecuting or defending litigation, complying with applicable governmental regulations, filing for, conducting preclinical or clinical trials, obtaining and maintaining regulatory approvals (including Regulatory Approvals), or otherwise required by Applicable Laws or the rules of a recognized stock exchange, provided, that if a Party is required by Applicable Laws or stock exchange 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, except to the extent inappropriate in the case of patent applications, will use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed; (iii) to its Affiliates and sublicensees, in each case under appropriate confidentiality provisions substantially equivalent to those of this Agreement; (iv) in communication with existing and potential investors, acquirers, consultants, advisors (including financial advisors, lawyers and accountants) and others on a need to know basis, in each case under appropriate confidentiality provisions substantially equivalent to those of this Agreement; or (v) to the extent mutually agreed to by the Parties.
7.3Prior Agreements.  This Agreement supersedes the Confidentiality Agreement between Talon and Licensee dated January 28, 2014 (the “Prior CDA”) with respect to information disclosed thereunder.  All information or materials disclosed or provided by Talon to Licensee under the Prior CDA shall be deemed Confidential Information of Talon (subject to the exceptions set forth herein) and shall be subject to Licensee’s confidentiality obligations under this Article 7.  All information disclosed by Licensee under the Prior CDA shall be deemed Confidential Information of Licensee (subject to the exceptions set forth herein) and shall be subject to Talon’s confidentiality obligations under this Article 7.
7.4Scientific Publications.  Licensee shall submit to Talon any proposed publication or public disclosure containing clinical or scientific results relating to the Product for use in the Field at least sixty (60) days in advance to allow Talon to review such proposed publication or disclosure.  Talon shall notify Licensee in writing during such sixty (60)-day reviewing period if Talon wishes to (a) remove its Confidential Information from such proposed publication or presentation, in which event Licensee shall remove such Confidential Information from its proposed publication or presentation; or (b) request a reasonable delay in publication or presentation in order to protect patentable information, in which event Licensee shall delay the publication or presentation for a period of no more than one hundred twenty (120) days to enable patent applications to be filed in accordance with Section 6.3 protecting inventions disclosed in such publication or presentation.   For clarity, if Talon fails to notify Licensee during the sixty (60)-day reviewing period as provided under this Section 7.4, Licensee shall be free to proceed with the proposed publication or presentation.
7.5Publicity.
7.5.1Confidential Terms.  Each of the Parties agrees not to disclose to any Third Party the terms and conditions of this Agreement without the prior approval of the other Party, except
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to advisors (including consultants, financial advisors, attorneys and accountants), potential and existing investors and acquirers on a need to know basis, in each case under circumstances that reasonably protect the confidentiality thereof, or to the extent necessary to comply with the terms of agreements with Third Parties, or to the extent required by Applicable Laws, including securities laws.  Notwithstanding the foregoing, the Parties agree upon the initial press release(s) to announce the execution of this Agreement, which is attached hereto as Exhibit 7.5.1; thereafter, Talon and Licensee may each disclose to Third Parties the information contained in such press release(s) without the need for further approval by the other.
7.5.2Publicity Review.  The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant developments regarding the Product for use in the Field in the Licensee Territory and other activities in connection with this Agreement, beyond what may be strictly required by Applicable Laws and the rules of a recognized stock exchange, and each Party may make such disclosures from time to time with the approval of the other Party, which approval shall not be unreasonably withheld, conditioned or delayed.  Such disclosures may include achievement of significant events in the Development (including regulatory process) or Commercialization of the Product for use in the Field in the Licensee Territory.  Unless otherwise requested by Talon, Licensee shall indicate that Talon is the owner and licensor of the Product and Talon Technology in each public disclosure issued by Licensee regarding the Product.  When Talon elects to make any such public disclosure under this Section 7.5.2, it will give Licensee reasonable notice to review and comment on such statement, it being understood that if Licensee does not notify Talon in writing within a three (3) Business Day period or such shorter period if required by Applicable Laws of any reasonable objections, as contemplated in this Section 7.5.2, such disclosure shall be deemed approved, and in any event Licensee shall work diligently and reasonably to agree on the text of any proposed disclosure in an expeditious manner.  The principles to be observed in such disclosures shall be accuracy, compliance with Applicable Laws and regulatory guidance documents, reasonable sensitivity to potential negative reactions of applicable Regulatory Authorities and the need to keep investors and others informed regarding the requesting Party’s business, including as required by the rules of a recognized stock exchange.
ARTICLE 8
REPRESENTATIONS, WARRANTIES AND COVENANTS; INDEMNIFICATION
8.1Licensee Representations and Warranties.  Licensee represents and warrants to Talon that:
8.1.1it is duly organized and validly existing under the Applicable Laws of the jurisdiction of its incorporation, and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
8.1.2it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate action;
8.1.3this Agreement is legally binding upon it and enforceable in accordance with its terms and the execution, delivery and performance of this Agreement by it does not conflict with
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any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material Applicable Laws;
8.1.4Licensee, its Affiliates and their employees and contractors have not and shall not, in connection with the performance of their respective obligations under this Agreement directly or indirectly through Third Parties, pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value to a public official or entity or other person for purpose of obtaining or retaining business for or with, or directing business to, any person, including Licensee (it being understood that, without any limitation to the foregoing, Licensee, and to its knowledge, its and its Affiliates’ employees and contractors, has not directly or indirectly promised, offered or provided any corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a public official or entity or any other person in connection with the performance of Licensee’s obligations under this Agreement, and shall not, directly or indirectly, engage in any of the foregoing).  Notwithstanding the foregoing, the intent of this warranty is to ensure compliance with the US Foreign Corrupt Practices Act of 1977, as amended, UK Bribery Act, and any rules or regulations thereunder or any similar anti-corruption or anti-bribery laws applicable to company or any of its affiliates or subsidiaries (in each case, as in effect at the time of such action).  Licensee will certify annually to conducting an effective compliance program and Talon will have rights to audit the Company’s compliance program periodically; and
8.1.5it is not aware of any action, suit or inquiry or investigation instituted by any Person which questions or threatens the validity of this Agreement.
8.2Talon’s Warranties.  Talon represents and warrants to Licensee, as of the Effective Date, that:
8.2.1it is duly organized and validly existing under the Applicable Laws of the jurisdiction of its incorporation, and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
8.2.2it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate action;
8.2.3this Agreement is legally binding upon it and enforceable in accordance with its terms and the execution, delivery and performance of this Agreement by it does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material Applicable Laws;
8.2.4it has the full right, power and authority under the Talon Technology, Talon Trademarks, and the Upstream Licenses to grant the licenses to Licensee as purported to be granted pursuant to this Agreement;
8.2.5as of the Effective Date, it has provided complete and unredacted copies of the Upstream Licenses and any relevant ancillary agreements, exhibits, schedules, or other documents
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including any and all amendments thereto) which set forth and are sufficient to fully describe all the terms and conditions with which Licensee must comply in relation to the Upstream Licenses;
8.2.6the Upstream Licenses represent all the material agreements Talon or its Affiliates have entered into that may affect Licensee’s exercise of the rights granted under this Agreement;
8.2.7it is not aware of any action, suit or inquiry or investigation instituted by any Person which questions or threatens the validity of this Agreement;
8.2.8as of the Effective Date, Talon has not granted, and will not grant during the Term, rights to any Third Party under the Talon Technology that conflict with the rights granted to Licensee hereunder;
8.2.9as of the Effective Date, Talon has not received any written notice of any threatened claims or litigation seeking to invalidate or otherwise challenge the Talon Patents or Talon’s rights therein;
8.2.10to its actual knowledge, as of the Effective Date, none of the Talon Patents are subject to any pending re-examination, opposition, interference or litigation proceedings; and
8.2.11to its actual knowledge, as of the Effective Date, the performance of Development and Commercialization activities in accordance with this Agreement will not infringe any Intellectual Property rights of any Third Party in the Licensee Territory, including any issued patent of any Third Party in the Licensee Territory or, if and when issued, any claim within any published patent application of any Third Party in the Licensee Territory.
8.3Disclaimer of Warranties.  EXCEPT AS SET FORTH IN THIS Article 8, TALON AND LICENSEE EXPRESSLY DISCLAIM ANY WARRANTIES OR CONDITIONS, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO THE SUBJECT MATTER OF THIS AGREEMENT (INCLUDING THE LICENSED TECHNOLOGY), INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE.
8.4Talon’s Representations, Warranties, and Covenants.  Talon represents, warrants and covenants to Licensee and agrees that:
8.4.1it and its Affiliates are in compliance, and it shall comply, and shall cause its Affiliates to comply, in all material respects, with all Upstream Licenses;
8.4.2it shall not, during the Term, amend any Upstream License in any manner that adversely affects the rights granted to Licensee hereunder or Talon’s ability to materially perform its obligations hereunder; and
8.4.3it and its Affiliates shall not, during the Term, do or fail to do any acts, which cause to be terminated or result in the termination of any Upstream Licenses or result in the loss of
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any rights under any Upstream Licenses, which would adversely affect the rights granted to Licensee hereunder or Talon’s ability to materially perform its obligations hereunder.
8.5Indemnification.
8.5.1Indemnification by Talon. Talon hereby agrees to defend, hold harmless and indemnify (collectively, “Indemnify”) Licensee and its Affiliates, and its and their agents, directors, officers and employees (the “Licensee Indemnitees”) from and against any liability or expense (including reasonable legal expenses and attorneys’ fees) (collectively, “Losses”) resulting from suits, claims, actions and demands, in each case brought by a Third Party (each, a “Third-Party Claim”) against any Licensee Indemnitee arising out of: (i) a breach of any of Talon’s representations and warranties under Section 8.2 or representations, warranties and covenants under Section 8.4; (ii) the Development, Commercialization or other exploitation of the Product by Talon, its Affiliates, or sub-licensees in the Talon Territory; or (iii) the gross negligence or intentional misconduct of any Talon Indemnities.  Talon’s obligation to Indemnify the Licensee Indemnitees pursuant to this Section 8.5.1 shall not apply to the extent that any such Losses (A) arise from the gross negligence or intentional misconduct of any Licensee Indemnitee; (B) arise from any breach by Licensee of this Agreement; or (C) are Losses for which Licensee is obligated to Indemnify the Talon Indemnitees pursuant to Section 8.5.2.
8.5.2Indemnification by Licensee.  Licensee hereby agrees to Indemnify Talon and its Affiliates, and its and their agents, directors, officers and employees (the “Talon Indemnitees”) from and against any and all Losses resulting from Third-Party Claims arising out of: (i) a breach of any of Licensee’s representations and warranties under Section 8.1; (ii) the Development, Commercialization or other exploitation of the Product by the Licensee, its Affiliates, or sub-licensees in the Licensee Territories; or (iii) the gross negligence or intentional misconduct of any Licensee Indemnities.  Licensee’s obligation to Indemnify the Talon Indemnitees pursuant to this Section 8.5.1 shall not apply to the extent that any such Losses (A) arise from the gross negligence or intentional misconduct of any Talon Indemnitee; (B) arise from any breach by Talon of this Agreement; or (C) are Losses for which Talon is obligated to Indemnify the Licensee Indemnitees pursuant to Section 8.5.1.
8.5.3Additional Indemnities.
(a)In addition to the indemnities set forth in Section 8.5.1, Talon hereby agrees to Indemnify the Licensee Indemnitees from and against any and all Losses resulting from any breach by Talon of Section 3.1 (Grant to Licensee), Section 4.1.4 (Rights of Reference), Section 4.2.3 (Development Assistance), or Section 8.4.3 (Talon’s Representations, Warranties, and Covenants), as single event or in combination with one or more breaches, that: (i) has a material adverse effect on Licensee’s Development or Commercialization of the Product in the Licensee Territory, and (ii) if curable, shall have continued uncured for ninety (90) days after written notice thereof was provided to Talon by Licensee.
(b)In addition to the indemnities set forth in Section 8.5.2, Licensee hereby agrees to Indemnify the Talon Indemnitees from and against any and all Losses resulting from any breach by Licensee of Section 3.1 (Grant to Licensee), Section 3.2.1 (Licensee Rights Limited to the
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Field and the Licensee Territory), Section 3.3 (Upstream Licenses), or Sections 4.2.4 and 4.3.2 (Diligence), as single event or in combination with one or more breaches, that: (i) has a material adverse effect on Talon’s rights under the Upstream Licenses, and (ii) if curable, shall have continued uncured for ninety (90) days after written notice thereof was provided to Licensee by Talon.
8.5.4Procedure. To be eligible to be Indemnified hereunder, the indemnified Party shall provide the indemnifying Party with prompt notice of the Third-Party Claim giving rise to the indemnification obligation pursuant to this Section 8.5 and the exclusive ability to defend (with the reasonable cooperation of the indemnified Party) or settle any such claim, provided, that the indemnifying Party shall not enter into any settlement that admits fault, wrongdoing or damages without the indemnified Party’s written consent, such consent not to be unreasonably withheld or delayed. The indemnified Party shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the indemnifying Party, provided, that the indemnifying Party shall have no obligations with respect to any Losses resulting from the indemnified Party’s admission, settlement or other communication without the prior written consent of the indemnifying Party.
8.6NO CONSEQUENTIAL DAMAGES. NOTWITHSTANDING THE FOREGOING, IN NO EVENT WILL EITHER PARTY BE LIABLE TO OTHER PARTY FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES UNDER THIS AGREEMENT, EXCEPT TO THE EXTENT THE DAMAGES RESULT FROM A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS HEREUNDER, GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, OR ARISE FROM EITHER PARTY’S INDEMNIFICATION OBLIGATIONS UNDER THIS Article 8 OR EITHER PARTY’S MATERIAL BREACH UNDER SECTION 9.10.
8.7MAXIMUM LIABILITY.  EXCEPT FOR A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS HEREUNDER, GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, IN NO EVENT SHALL THE MAXIMUM AGGREGATE LIABILITY OF EITHER PARTY IN RESPECT OF ALL CLAIMS UNDER THIS AGREEMENT EXCEED THE [***].
ARTICLE 9
TERM AND TERMINATION AND MATERIAL BREACH
9.1Term.  This Agreement shall become effective as of the Effective Date and, unless earlier terminated pursuant to the other provisions of this Article 9, shall be perpetual (the “Term”).
9.2Termination for Breach.  Each Party may terminate this Agreement in the event the other Party materially breaches this Agreement, and such breach, if curable, shall have continued uncured for ninety (90) days after written notice thereof was provided to the breaching Party by the terminating Party.  Any such termination shall become effective at the end of such ninety (90) day period unless, if applicable, the breaching Party has cured any such breach prior to the expiration of such ninety (90) day period.
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9.3Termination for Patent Challenge.  If Licensee or any of its Affiliates challenges under any court action or proceeding, or before any patent office, the validity, patentability, enforceability, scope or non-infringement of any Talon Patent, or initiates a reexamination of any Talon Patent, or assists any Third Party to conduct any of the foregoing activities (each, a “Challenge”), Talon will have the right to immediately terminate this Agreement.  In any event, Licensee shall notify Talon at least thirty (30) days prior to initiating any such Challenge.
9.4Termination of Upstream Licenses.  To the extent any Upstream License is terminated, the rights granted hereunder with respect to such Upstream License shall also terminate.
9.5Termination for Insolvency. Each Party shall have the right to terminate this Agreement upon delivery of written notice to the other Party in the event that (i) such other Party files in any court or agency pursuant to any statute or regulation of any jurisdiction a petition in bankruptcy or insolvency or for reorganization or similar arrangement for the benefit of creditors or for the appointment of a receiver or trustee of such other Party or its assets, (ii) such other Party is served with an involuntary petition against it in any insolvency proceeding and such involuntary petition has not been stayed or dismissed within ninety (90) days of its filing, or (iii) such other Party makes an assignment of substantially all of its assets for the benefit of its creditors.
9.6Provision for Insolvency. All rights and licenses granted under or pursuant to any Section of this Agreement are rights to “intellectual property” (as defined in Section 101(35A) of Bankruptcy Code).  Each Party hereby acknowledges that (i) copies of research data, (ii) laboratory samples, (iii) product samples, (iv) formulas, (v) laboratory notes and notebooks, (vi) data and results related to clinical trials, (vii) Regulatory Filings and Regulatory Approvals, (viii) rights of reference in respect of Regulatory Filings and Regulatory Approvals, (ix) pre-clinical research data and results, and (x) marketing, advertising and promotional materials, in each case, that relate to such intellectual property, constitute “embodiments” of such intellectual property pursuant to Section 365(n) of the Bankruptcy Code.  Each Party agrees not to interfere with the other Party’s exercise, pursuant to Section 365(n) of the Bankruptcy Code, of rights and licenses to intellectual property licensed hereunder and embodiments thereof and agrees to use Commercially Reasonable Efforts to assist such other Party to obtain such intellectual property and embodiments thereof in the possession or control of Third Parties as reasonably necessary for such other Party to exercise, pursuant to Section 365(n) of the Bankruptcy Code, such rights and licenses.  Each Party shall take any and all action requested by the other Party to ensure that the foregoing provisions of this Section 9.6 may be fully effectuated under Applicable Laws, and, if requested by the other Party, each Party shall procure that any past, existing or future creditor of the other Party irrevocably waives in writing any and all rights that such creditor may have to the intellectual property licensed hereunder and embodiments thereof.
9.7General Effects of Termination.
9.7.1Termination of Rights.  In the event of termination of this Agreement for any reason, all rights and licenses granted to Licensee herein shall immediately terminate, except as set forth in Section 9.8.
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9.7.2Accrued Obligations.  Termination of this Agreement for any reason shall not release either Party of any obligation or liability which, at the time of such termination, has already accrued to the other Party or which is attributable to a period prior to such termination.
9.7.3Non-Exclusive Remedy.  Notwithstanding anything herein to the contrary, termination of this Agreement by a Party shall be without prejudice to other remedies such Party may have at law or equity.
9.7.4General Survival.  Article 1 (Definitions), Article 6 (Intellectual Property), Article 7 (Confidentiality), Article 10 (Dispute Resolution), Article 11 (Miscellaneous) and Sections 5.5 (Records; Audit)(for a period of three (3) years after the effectiveness of the termination of this Agreement), 8.5 (Indemnification), 8.6 (No Consequential Damages), 8.7 (Maximum Liability), 9.7 (General Effects of Termination), 9.8 (Additional Effects of Termination), 9.9 (Termination Press Releases), and 9.10 (Material Breach) shall survive termination of this Agreement for any reason.  Except as otherwise provided in this Article 9, all rights and obligations of the Parties under this Agreement shall terminate upon termination of this Agreement for any reason.
9.8Additional Effects of Certain Terminations.  If this Agreement is terminated by Talon, then:
9.8.1Ongoing Trials.  If there are any ongoing clinical trials with respect to the Product being conducted by or on behalf of Licensee (or its Affiliate) at the time of notice of termination, Licensee agrees to (i) promptly transition to Talon or its designee some or all of such clinical trials and the activities related to or supporting such trials, or (ii) terminate such clinical trials in each case, as requested by Talon.  The Parties recognize that early termination of this Agreement requires both discussion and coordination between the Parties to ensure patient safety, continuity of treatment, if appropriate, and compliance with Applicable Laws.  Upon early termination of this Agreement, the Parties shall cooperate to provide for an orderly transition or cessation of any clinical trials, as requested by Talon.  Each Party further agrees to take no action or forego taking action if such action or forbearance would in any manner jeopardize patient safety or cause the other Party to violate any Applicable Laws.
9.8.2Commercialization.  To avoid a disruption in the supply of the Product, if this Agreement is terminated after the First Commercial Launch of the Product for use in the Field in the Licensee Territory, Licensee and its Affiliates shall continue to distribute and sell such Product for use in the Field in the Licensee Territory, in accordance with the terms and conditions of this Agreement, for a period reasonably sufficient for them to sell off all amounts of Product in Licensee’s inventory not to exceed [***] ([***]) months from the effective date of such termination (the “Wind-Down Period”).  Notwithstanding any other provision of this Agreement, during this Wind-Down Period, Licensee’s and its Affiliates’ rights with respect to the Product (including the licenses granted under Section 3.1) shall be non-exclusive and Talon shall have the right to engage one or more partners(s) or distributor(s) of the Product in all or part of the Licensee Territory.  During the Wind-Down Period, Licensee shall continue to make any and all Upstream Payments to Talon for the Product sold or disposed by Licensee, its Affiliates, or its sublicensees.  After the Wind-Down Period, Licensee and its Affiliates shall not sell the Product or make any representation regarding their status as a licensee of or distributor for Talon for the Product.  Within thirty (30) days of expiration of the Wind-Down
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Period, Licensee shall notify Talon of any quantity of the Product remaining in Licensee’s inventory and Talon shall have the option, upon notice to Licensee, to purchase any such quantities of the Product, as applicable, from Licensee at a price equal to the amounts paid by Licensee for such Product.
9.8.3Regulatory Filings.  Licensee shall promptly assign and transfer to Talon all Regulatory Filings for the Product that are held or controlled by or under authority of Licensee, and shall take such actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights under the Regulatory Filings to Talon.  Licensee shall cause each of its Affiliates or sublicensees to transfer any such Regulatory Filings to Talon if this Agreement terminates.  If Applicable Laws prevents or delays the transfer of ownership of a Regulatory Filing to Talon, Licensee shall grant, and does hereby grant, to Talon an exclusive and irrevocable right of access and reference to such Regulatory Filing for the Product, and shall cooperate fully to make the benefits of such Regulatory Filings available to Talon and/or its designee(s).  Within sixty (60) days after notice of such termination, Licensee shall provide to Talon copies of all such Regulatory Filings, and of all preclinical and clinical data (including raw data, original records, investigator reports, both preliminary and final, statistical analyses, expert opinions and reports, safety and other electronic databases) and other Know-How pertaining to the Product, or the manufacture thereof.  Talon shall be free to use and disclose such Regulatory Filings and other items in connection with the exercise of its rights and licenses under this Section 9.8.
9.8.4License to Talon.  Licensee hereby grants Talon, effective upon the effective date of termination of this Agreement, a perpetual, irrevocable, fully paid-up, royalty free, non-exclusive license, with the right to grant sublicenses at any tier, under Licensee Know-How (including, without limitation, Licensee Inventions) and Licensee’s rights in the Joint Inventions, to research, Develop, make, have made, use, sell, offer for sale, have sold, import and otherwise Commercialize the Product in the Licensee Territory.
9.8.5Transition Assistance.  Licensee agrees to fully cooperate with Talon and its designee(s) to facilitate a smooth, orderly and prompt transition of the Development and Commercialization of the Product to Talon and/or its designee(s) during this Wind-Down Period.  Without limiting the foregoing, Licensee shall promptly provide Talon (i) all commercial data generated by Licensee under this Agreement including copies of customer lists, customer data and other customer information relating to the Product, and (ii) manufacturing information (including protocols for the production, packaging, testing and other manufacturing activities) relating to the Product in Licensee’s Control, which in each case Talon shall have the right to use and disclose for any purpose during this Wind-Down Period and thereafter.  Upon request by Talon, Licensee shall transfer to Talon some or all quantities of the Product in its or its Affiliates’ Control (as requested by Talon), within thirty (30) days after the end of this Wind-Down Period, provided, that Talon shall reimburse Licensee for the out-of-pocket costs that Licensee actually incurred to manufacture or otherwise acquire the quantities so provided to Talon.  If any Product was manufactured by any Third Party for Licensee, or Licensee had contracts with vendors which contracts are necessary or useful for Talon to take over responsibility for the Product in the Licensee Territory, then Licensee shall to the extent possible and requested in writing by Talon, assign all of the relevant Third-Party contracts to Talon, and in any case, Licensee agrees to cooperate with Talon to ensure uninterrupted supply of the Product.  If Licensee or its Affiliate manufactured any Product at the time of termination, then Licensee
​

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(or its Affiliate) shall continue to provide for manufacturing of such Product for Talon, at its fully-burdened manufacturing cost therefor, from the date of notice of such termination until such time as Talon is able, using Commercially Reasonable Efforts to do so but no longer than the expiration of the Wind-Down Period, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of the Product may be procured and legally sold in the Licensee Territory.
9.8.6Costs and Expenses.  Except as expressly provided herein, Licensee shall perform its obligations under this Section 9.8 at its own costs without consideration from Talon.  Talon shall be responsible for its own costs of performing its activities under this Section 9.8.
9.9Termination Press Releases.  In the event of termination of this Agreement for any reason, the Parties shall cooperate in good faith to coordinate public disclosure of such termination and the reasons therefor, and shall not, except to the extent required by Applicable Laws or the rules of a recognized stock exchange, disclose such information without the prior approval of the other Party, such approval not to be unreasonably withheld, conditioned or delayed.  When Talon elects to make a public disclosure under this Section 9.9, Talon shall provide Licensee with a draft of any such public disclosure it intends to issue three (3) Business Days in advance and with the opportunity to review and comment on such statement, it being understood that if Licensee does not notify Talon in writing within such three (3) Business Day period (or such shorter period if required by Applicable Laws or the rules of a recognized stock exchange) of any reasonable objections, such disclosure shall be deemed approved, and in any event the Parties shall work diligently and reasonably to agree on the text of any such proposed disclosure in an expeditious manner.  The principles to be observed in such disclosures shall be accuracy, compliance with Applicable Laws and regulatory guidance documents, reasonable sensitivity to potential negative reactions to such news and the need to keep investors and others informed regarding the Parties’ business and other activities.
9.10Material Breach.
9.10.1Talon agrees that any breach by Talon of Section 3.1 (Grant to Licensee), Section 4.1.4 (Rights of Reference), Section 4.2.3 (Development Assistance), or Section 8.4.3 (Talon’s Representations, Warranties, and Covenants) as single event or in combination with one or more breaches, that has a material adverse effect on Licensee’s Development or Commercialization of the Product in the Licensee Territory shall be deemed a material breach by Talon of this Agreement, and, if such breach, if curable, shall have continued uncured for ninety (90) days after written notice thereof was provided to Talon by Licensee,  then: (a) subject to Section 8.7, Licensee shall be entitled to recovery of damages for such material breach without any limitation on the amount or type of damages (including special, consequential (including loss of profits and loss of revenue), incidental, punitive or indirect damages); and (b) Licensee, in addition to being entitled to exercise all rights provided herein (unless Licensee has also terminated this Agreement under Section 9.2) or granted by law, including, without limitation, recovery of damages, will be entitled to specific performance of its rights and Talon’s obligations under the above Sections 3.1 (Grant to Licensee), Section 4.1.4 (Rights of Reference), Section 4.2.3 (Development Assistance), or Section 8.4.3 (Talon’s Representations, Warranties, and Covenants) of the Agreement, without the necessity of posting any bond and without the necessity of establishing that monetary relief would not provide an adequate remedy. Talon agrees that Licensee may seek, and AAA (or any court having competent jurisdiction in relation to any injunctive or provisional relief necessary) may grant, specific performance in the event of such Talon’s
​

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material breach, and that monetary damages would not be adequate compensation for any loss incurred by reason of a material breach by Talon as recited in this Section of this Agreement, and hereby agrees to waive any defense in any action for specific performance, including that a remedy at law would be adequate.
9.10.2Licensee agrees that any breach by Licensee of Section 3.1 (Grant to Licensee), Section 3.2.1 (Licensee Rights Limited to the Field and the Licensee Territory), Section 3.3 (Upstream Licenses), or Sections 4.2.4 and 4.3.2 (Diligence) as single event or in combination with one or more breaches, that has a material adverse effect on Talon’s rights under the Upstream Licenses shall be deemed a material breach by Licensee of this Agreement, and, if such breach, if curable, shall have continued uncured for ninety (90) days after written notice thereof was provided by Talon to Licensee, then: (a) subject to Section 8.7, Talon shall be entitled to recovery of damages for such material breach without any limitation on the amount or type of damages (including special, consequential (including loss of profits and loss of revenue), incidental, punitive or indirect damages); and (b) Talon, in addition to being entitled to exercise all rights provided herein or granted by law, including, without limitation, recovery of damages, will be entitled to specific performance of its rights and Licensee’s obligations under the above Sections 3.1 (Grant to Licensee), Section 3.2.1 (Licensee Rights Limited to the Field and the Licensee Territory), Section 3.3 (Upstream Licenses), or Sections 4.2.4 and 4.3.2 (Diligence) of the Agreement, without the necessity of posting any bond and without the necessity of establishing that monetary relief would not provide an adequate remedy.  Licensee agrees that Talon may seek, and AAA (or any court having competent jurisdiction in relation to any injunctive or provisional relief necessary) may grant, specific performance in the event of such Licensee’s material breach, and that monetary damages would not be adequate compensation for any loss incurred by reason of a material breach by Licensee as recited in this Section of this Agreement, and hereby agrees to waive any defense in any action for specific performance, including that a remedy at law would be adequate.
ARTICLE 10
DISPUTE RESOLUTION
10.1Disputes.  If the Parties are unable to resolve any dispute or other matter arising out of or in connection with this Agreement (“Dispute”), either Party may, by written notice to the other, have such Dispute referred to the respective business heads of the Parties for attempted resolution by good faith negotiations within fifteen (15) Business Days after such notice is received.  In such event, each Party shall cause its respective business head to meet (face-to-face or by teleconference) and be available to attempt to resolve such Dispute. If the Parties should resolve such Dispute under this Section 10.1, a memorandum setting forth their agreement will be prepared and signed by both Parties if requested by either Party.  The Parties shall cooperate in an effort to limit the issues for consideration in such manner as narrowly as reasonably practicable in order to resolve the Dispute.  If the Parties are unable to resolve such Dispute under this Section 10.1, then either Party may submit such Dispute to arbitration pursuant to Section 10.2 below or initiate proceedings pursuant to Section 10.3 below, as applicable.  No Dispute shall be submitted to arbitration under Section 10.2 below and no proceedings shall be initiated pursuant to Section 10.3 below, as applicable, until the following procedures in this Section 10.1 have been satisfied, unless the Senior Executives have already attempted to resolve such Dispute pursuant to Section 2.3, in which case, either Party may refer such Dispute to arbitration pursuant to Section 10.2 below or initiate proceedings pursuant to Section 10.3 below, as applicable, provided, that any applicable statute of limitations with respect to such Dispute
​

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shall be tolled while the Parties attempt to resolve such Dispute in accordance with Section 2.3 or this Section 10.1.
10.2Arbitration.  Except with respect to Disputes related to Intellectual Property rights as provided under Section 10.3 below, if the Parties are unable to resolve a Dispute under Section 10.1 above, either Party may, upon written notice to the other Party, submit such Dispute for resolution by final, binding arbitration in the manner described in this Section 10.2 below, as applicable.  Any arbitration under this Section 10.2 below, as applicable, shall be conducted by the American Arbitration Association (“AAA”) in New York, New York in accordance with the then-current Commercial Rules of Arbitration of AAA (“AAA Rules”), except as modified by this Section 10.2 below, as applicable.  The arbitration shall be conducted by a single arbitrator.  The costs of such arbitration shall be shared equally by the Parties, and each Party shall bear its own expenses in connection with the arbitration.  The Parties shall use good faith efforts to complete arbitration under this Section 10.2 within ninety (90) days following the initiation of such arbitration.  The arbitrator shall establish reasonable additional procedures to facilitate and complete such arbitration within such ninety (90) day period.  Nothing in this Agreement shall limit the right of either Party to seek to obtain in any court of competent jurisdiction any equitable or interim relief or provisional remedy, including injunctive relief.
10.3Other Disputes.  If the Parties are unable to resolve a Dispute related to Intellectual Property rights under Section 10.1 above, either Party may initiate legal proceedings with respect thereto.  Each of the Parties irrevocably agrees that the federal or state courts in New York, New York shall have the exclusive jurisdiction to hear and decide any suit, action, proceedings, and/or settle any such Disputes, and for these purposes, each Party irrevocably submits to the jurisdiction of the courts of New York.  EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY LAW, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING (WHETHER SOUNDING IN CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR RELATED TO THIS AGREEMENT.
ARTICLE 11
MISCELLANEOUS
11.1Affiliates; Licensees.  For clarity and without limitation, each Party shall have the right to exercise any of its rights and licenses or perform or delegate all or any portion of any of its obligations under this Agreement through any of its Affiliates, provided, that each Party shall remain responsible to the other Party under this Agreement for all activities of its Affiliates to the same extent as if such activities had been undertaken by such Party itself.  In addition, Talon shall have the right to exercise any of its rights and licenses or perform or delegate all or any portion of any of its obligations under this Agreement through any of its Third Party licensees, provided, that Talon shall require each such licensee to be bound by a written agreement containing terms and conditions consistent with the terms and conditions of this Agreement.
11.2Governing Law.  This Agreement and any dispute arising from the performance or breach hereof shall be governed by and construed and enforced in accordance with the laws of the State of New York, without reference to conflicts of laws principles.
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11.3Assignment.  This Agreement shall not be assignable by either Party to any Third Party without the written consent of the other Party and any such attempted assignment shall be void.  Notwithstanding the foregoing, either Party may assign this Agreement, without the written consent of the other Party, to an Affiliate of such Party or an entity that acquires all or substantially all of the business or assets of such Party to which this Agreement pertains (whether by merger, reorganization, acquisition, sale, operation of law or otherwise), and agrees in writing to be bound by the terms and conditions of this Agreement.  No assignment or transfer of this Agreement shall be valid and effective unless and until the assignee/transferee agrees in writing to be bound by the provisions of this Agreement.  The terms and conditions of this Agreement shall be binding on and inure to the benefit of the permitted successors and assigns of the Parties.  Except as expressly provided in this Section 11.3, any attempted assignment or transfer of this Agreement shall be null and void.
11.4Notices.  Any notice, request, delivery, approval or consent required or permitted to be given under this Agreement shall be in writing and shall be deemed to have been sufficiently given if delivered in person, transmitted by facsimile (receipt verified) or by express courier service (signature required) or five (5) days after it was sent by registered letter, return receipt requested (or its equivalent), provided, that no postal strike or other disruption is then in effect or comes into effect within two (2) days after such mailing, to the Party to which it is directed at its address or facsimile number shown below or such other address or facsimile number as such Party will have last given by notice to the other Party.
	If to Talon, addressed to:
	Talon Therapeutics, Inc.

	​
	11500 South Eastern Ave. Suite 240

	​
	Henderson, NV 89052

	​
	Attn: Legal Department

	​
	Telephone number:   (702) 835-6300

	​
	Facsimile number:    (702) 260-7405

	​
	​

	With a copy to:
	Stradling Yocca Carlson & Rauth

	​
	660, Newport Center Dr, Suite 1600

	​
	Newport Beach, CA 92660

	​
	Attn: Shivbir S. Grewal, Esq.

	​
	Telephone number:   (949) 725-4000

	​
	Facsimile number:    (949) 725-4100

	​
	​

	If to Licensee, addressed to:
	CASI Pharmaceuticals, Inc.

	​
	9620 Medical Center Drive, Suite 300

	​
	Rockville, MD 20850

	​
	Attn: General Counsel

	​
	​

	​
	Telephone number:   (240) 864-2781

	​
	Facsimile number:    (240) 864-2782

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	​

	​

	With a copy to:
	Ropes & Gray LLP

	​
	36F, Park Place 1601 Nanjing Road West

	​
	Shanghai 200040, China

	​
	Attention: Geoffrey Lin and Arthur Mok

	​
	Telephone:  +86 21 6157 5200

	​
	Facsimile: + 86 21 6157 5299

​
11.5Waiver.  Neither Party may waive or release any of its rights or interests in this Agreement except in writing.  The failure of either Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition.  No waiver by either Party of any condition or term in any one or more instances shall be construed as a continuing waiver of such condition or term or of another condition or term.
11.6Severability.  If any provision hereof should be held invalid, illegal or unenforceable in any jurisdiction, the Parties shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all other provisions hereof shall remain in full force and effect in such jurisdiction and shall be liberally construed in order to carry out the intentions of the Parties as nearly as may be possible.  Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such provision in any other jurisdiction.  If a Party seeks to avoid a provision of this Agreement by asserting that such provision is invalid, illegal or otherwise unenforceable, the other Party shall have the right to terminate this Agreement pursuant to Section 9.2 upon sixty (60) days prior written notice to the asserting Party, unless such assertion is eliminated and cured within such sixty (60) day period.
11.7Entire Agreement/Modification.  This Agreement, including its Exhibits, sets forth all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties and supersedes and terminates all prior agreements and understandings between the Parties including the Prior CDA.  No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by the respective authorized officers of the Parties.
11.8Relationship of the Parties.  The Parties agree that the relationship of Talon and Licensee established by this Agreement is that of independent contractors.  Furthermore, the Parties agree that this Agreement does not, is not intended to, and shall not be construed to, establish an employment, agency or any other relationship.  Except as may be specifically provided herein, neither Party shall have any right, power or authority, nor shall they represent themselves as having any authority to assume, create or incur any expense, liability or obligation, express or implied, on behalf of the other Party, or otherwise act as an agent for the other Party for any purpose.
11.9Force Majeure.  Except with respect to payment of money, neither Party shall be liable to the other for failure or delay in the performance of any of its obligations under this Agreement for the time and to the extent such failure or delay is caused by earthquake, riot, civil commotion, war, terrorist acts, strike, flood, change of law, political unrest, or governmental acts or restriction, or other cause that is beyond the reasonable control of the respective Party.  The Party affected by such force majeure will provide the other Party with full particulars thereof as soon as it becomes aware of the
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same (including its best estimate of the likely extent and duration of the interference with its activities), and will use Commercially Reasonable Efforts to overcome the difficulties created thereby and to resume performance of its obligations as soon as practicable.  If the performance of any such obligation under this Agreement is delayed owing to such a force majeure for any continuous period of more than one hundred eighty (180) days, the Parties will consult with respect to an equitable solution, including the possibility of the mutual termination of this Agreement.
11.10Compliance with Applicable Laws/Other.  Notwithstanding anything to the contrary contained herein, all rights and obligations of Talon and Licensee are subject to prior compliance with, and each Party shall comply with, all Applicable Laws, including obtaining all necessary approvals required by the applicable agencies of the governments of the relevant jurisdictions.  In addition, each Party shall conduct its activities under this Agreement in accordance with good scientific and business practices.
11.11Interpretation.  The captions and headings to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement.  Unless specified to the contrary, references to Articles, Sections or Exhibits mean the particular Articles, Sections or Exhibits to this Agreement and references to this Agreement include all Exhibits hereto.  Unless context otherwise clearly requires, whenever used in this Agreement:  (i) the words “include” or “including” shall be construed as incorporating, also, “but not limited to” or “without limitation;” (ii) the word “day” or “year” means a calendar day or year unless otherwise specified; (iii) the word “notice” shall mean notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement; (iv) the words “hereof,” “herein,” “hereby” and derivative or similar words refer to this Agreement (including any Exhibits); (v) the word “or” shall be construed as the inclusive meaning identified with the phrase “and/or;”(vi) provisions that require that a Party, the Parties or a committee hereunder “agree,” “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise; (vii) words of any gender include the other gender; (viii) words using the singular or plural number also include the plural or singular number, respectively; (ix) references to any specific law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement law, rule or regulation thereof; and (x) neither Party or its Affiliates shall be deemed to be acting “on behalf of” the other Party hereunder.
11.12Counterparts.  This Agreement may be executed in two counterparts, each of which shall be deemed an original, and all of which together, shall constitute one and the same instrument.
[The remainder of this page intentionally left blank; the signature page follows.]
​
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​
IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate originals by their duly authorized representatives as of the Effective Date.
​
​
	​

	​

	​

	​

	​

	TALON THERAPEUTICS, INC.
	    
	CASI PHARMACEUTICALS, INC.

	​
	​
	​
	​
	​

	By:
	/s/ Joseph W. Turgeon
	​
	By:
	/s/ Ken K. Ren

	Name:
	Joseph W. Turgeon
	​
	Name:
	Ken K. Ren

	Title:
	President
	​
	Title:
	Chief Executive Officer

​
​
List of Exhibits:
Exhibit 1.66:  Talon Patents
Exhibit 1.69:  Talon Trademarks
Exhibit 5.1:  Note
Exhibit 7.5.1:  Press Release(s)
​

Exhibit 1.66
Talon Patents
	​

	​

	​

	​

	​

	​

	Title
	Application No.
	Country
	Patent No.
	Publication No.
	PCT Filing Date

	[***]
	[***]
	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]
	[***]
	[***]

​
​

​

Exhibit 1.69
Talon Trademarks
MarqiboTM.
​

​

Exhibit 5.1
Note
​

​

Exhibit 7.5.1
Press Release(s)
See attached.
​

​

Spectrum Pharmaceuticals Out-Licenses
Rights for Greater China to CASI Pharmaceuticals for Three of Its Drugs
​
		●	Spectrum receives a 19.99% stake (pre-transaction) in CASI, a NASDAQ-listed, oncology-focused Company with expertise and focus on markets in China and a $1.5 million promissory note

​
HENDERSON, Nev. and ROCKVILLE, Md. (September 18, 2014) – Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, and CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a primary focus on China, announce the signing of license agreements whereby CASI has been granted exclusive rights to two of Spectrum Pharmaceuticals’ commercial oncology drugs, Zevalin® (ibritumomab tiuxetan) Injection for intravenous use and Marqibo® (vinCRIStine sulfate LIPOSOME injection) for intravenous infusion, and a Phase 3 drug candidate, Captisol-EnabledTM Melphalan (CE melphalan), for development and commercialization in China, including Taiwan, Hong Kong and Macau.
ZEVALIN is used in the treatment of non-Hodgkin’s lymphoma (NHL) and MARQIBO is used in the treatment of acute lymphoblastic leukemia (ALL). CE melphalan has met the endpoints in a pivotal trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma. Spectrum plans to file a New Drug Application with the U.S. Food and Drug Administration (FDA) for CE melphalan in the second half of 2014.
CASI will be responsible for the development and commercialization of the three drugs, including the submission of import drug registration applications to regulatory authorities and conducting any confirmatory clinical studies in greater China, if and as required.
“We are delighted to see our anticancer drugs to be developed and marketed in greater China through CASI, a NASDAQ-listed Company focused on China,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “The management of CASI has a track record of successfully developing anticancer drugs in China. We are pleased to be a shareholder of CASI at this early stage of their development and look forward to CASI creating value for our shareholders as they grow. China’s pharmaceutical market is growing at a rapid pace and is already approaching second place to only the United States in the world. The greater China drug market for anticancer drugs is projected to become the world’s largest in the next decade and CASI has the opportunity to take a leading position to address these significant unmet medical needs. We are impressed with the management team at CASI and their expertise in China, and look forward to sharing in the success of our drugs in this important market.”
Spectrum Pharmaceuticals, Inc., 11500 S. Eastern Ave., Ste. 240   ●   Henderson, Nevada 89052   ●   Tel: 702-835-6300
●   Fax: 702-260-7405   ●   www.sppirx.com   ●   NASDAQ: SPPI
CASI Pharmaceuticals, Inc., 9620 Medical Center Drive, Ste. 300   ●   Rockville, Maryland 20852   ●   Tel: 240-864-2643
●   Fax: 301-325-2437   ●   www.casipharmaceuticals.com   ●   NASDAQ: CASI
​

​

Commenting on the transaction, Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, said, “We are very excited to have entered into this transaction with Spectrum, a Company with a successful track record of developing and commercializing drugs expeditiously in the U.S. The addition of these three drugs transforms our pipeline and significantly expands our market share potential in China. Our transaction is structured rather uniquely in that the shares and note represent the purchase price to Spectrum and is in lieu of royalties and milestones normally associated with traditional licenses, thereby aligning Spectrum’s interest with our shareholders. We look forward to a productive relationship with Spectrum.”
Dr. Ren added, “These drug products come with strong intellectual property protection and significant technology barriers. We are currently preparing the import drug registration applications in greater China, initially for ZEVALIN and MARQIBO, and since both drugs are approved for sale in the U.S., we anticipate that confirmatory clinical trials will be required for marketing approval in our territory. The submission of the import drug registration for CE melphalan will follow immediately after its approval by the U.S. FDA. The annual incidence in China for NHL, ALL and multiple myeloma is increasing each year with high mortality rates, it is our goal to have these innovative products available to patients in greater China as soon as possible to address these unmet medical needs, and as Spectrum expands these drugs into additional indications in the U.S., we too will apply for expanded labels in our territory.”
In addition to its initial stake in CASI, Spectrum Pharmaceuticals will have certain rights to maintain its post-transaction ownership position. Spectrum Pharmaceuticals also will have the opportunity to designate a member to CASI’s board of directors. Detailed information on the transaction can be found in CASI’s Report on Form 8-K, which will be filed with the Securities and Exchange Commission.
H.C. Wainwright & Co., LLC acted as Spectrum's advisor.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in oncology and hematology. Spectrum and its affiliates market five oncology drugs: FUSILEV® (levoleucovorin) for Injection; FOLOTYN® (pralatrexate injection); ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use; MARQIBO® (vinCRIStine sulfate LIPOSOME injection) for intravenous infusion; and BELEODAQTM (belinostat) for Injection. Spectrum's strong track record in in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.
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About CASI Pharmaceuticals, Inc.
CASI is a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a primary focus on China.. CASI’s product pipeline includes exclusive regional rights to ZEVALIN (ibritumomab tiuxetan), MARQIBO (vinCRIStine sulfate LIPOSOME injection) and Captisol-Enabled (propylene glycol-free) melphalan (CE melphalan) in greater China (including Taiwan, Hong Kong and Macau). CASI’s development pipeline also includes its proprietary drug candidate ENMD-2076, a selective angiogenic kinase inhibitor currently in multiple Phase 2 oncology studies, and 2ME2 (2-methoxyestradial) currently under reformulation development. CASI is headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D operations in Beijing, China. More information on CASI is available at www.casipharmaceuticals.comand in the Company’s filings with the U.S. Securities and Exchange Commission.
About ZEVALIN and the ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan) injection for intravenous use, is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). ZEVALIN is also indicated for the treatment of patients with previously untreated follicular non-Hodgkin's Lymphoma who achieve a partial or complete response to first-line chemotherapy.
ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of two components: rituximab, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. ZEVALIN builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.
Important ZEVALIN Safety Information
Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. ZEVALIN administration can result in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen.
Please see full Prescribing Information, including BOXED WARNINGS, for ZEVALIN and rituximab. Full prescribing information for ZEVALIN can be found at www.ZEVALIN.com.
About MARQIBO
MARQIBO is a novel, sphingomyelin/cholesterol liposome-encapsulated, formulation of vincristine sulfate. Vincristine, a microtubule inhibitor, is FDA-approved for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. (The encapsulation technology, utilized in this formulation, has been shown to provide prolonged circulation of vincristine in the blood).
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Please see important safety information below and the full prescribing information for MARQIBO at www.marqibo.com.
Indication and usage
MARQIBO is a liposomal vinca alkaloid indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. This indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified.
Important safety information
CONTRAINDICATIONS
●MARQIBO is contraindicated in patients with demyelinating conditions including Charcot-Marie-Tooth syndrome
		●	MARQIBO is contraindicated in patients with hypersensitivity to vincristine sulfate or any of the other components of MARQIBO (vinCRIStine sulfate LIPOSOME injection

●MARQIBO is contraindicated for intrathecal administration
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About Captisol-Enabled Melphalan
Captisol-enabled, PG-free melphalan is a novel intravenous formulation of melphalan being investigated for the multiple myeloma transplant setting, for which it has been granted an Orphan Drug Designation by the FDA. This formulation eliminates the use of propylene glycol, which has been reported to cause renal and cardiac side effects that limit the ability to deliver higher doses of therapeutic compounds. The use of the Captisol technology to reformulate melphalan also improves its stability and is anticipated to allow for slower infusion rates and longer administration durations, potentially enabling clinicians to safely achieve a higher dose intensity for pre-transplant chemotherapy.
About Captisol
Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled seven FDA-approved products, including Onyx Pharmaceuticals’ Kyprolis®, Baxter International’s Nexterone® and Merck’s NOXAFIL IV. There are also more than 30 Captisol-enabled products currently in clinical development.
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Forward-Looking Statements – Spectrum Pharmaceuticals, Inc.
This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management's current beliefs and expectations. These statements include, but are not limited to, statements that relate to our business and its future, including sales of Spectrum’s drug products, certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of sustained revenue history, our limited marketing experience, our customer concentration, the possibility for fluctuations in customer orders, evolving market dynamics, our dependence on third parties for clinical trials, manufacturing, distribution, information and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC. ®, FUSILEV®, FOLOTYN®, ZEVALIN®, and MARQIBO® are registered trademarks of Spectrum Pharmaceuticals, Inc. and its affiliates. BELEODAQTM, REDEFINING CANCER CARETM and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.
© 2014 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Forward-Looking Statements – CASI Pharmaceuticals, Inc.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed.
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Actual results could differ materially from those currently anticipated due to a number of factors, including: the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on the Nasdaq Capital Market; the volatility in the market price of our common stock; the difficulty of executing our business strategy in China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidate or future candidates; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; risks associated with our product candidates; risks associated with any early-stage products under development; the risk that results in preclinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; the lack of success in the clinical development of any of our products; dependence on third parties; and risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks). Such factors, among others, could have a material adverse effect upon our business, results of operations and financial condition. We caution readers not to place undue reliance on any forward-looking statements, which only speak as of the date made. Additional information about the factors and risks that could affect our business, financial condition and results of operations, are contained in our filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.
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	SPECTRUM INVESTOR CONTACT:
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Spectrum Pharmaceuticals, Inc.
Shiv Kapoor
Vice President, Strategic Planning & Investor 
Relations
702-835-6300
InvestorRelations@sppirx.com
	CASI INVESTOR CONTACTS:
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CASI Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com
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LHA
Kim Sutton Golodetz
212.838.3777
kgolodetz@lhai.com

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#  #  #

​Exhibit 10.8
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ASSET PURCHASE AGREEMENT
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Between
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CASI PHARMACEUTICALS, INC.
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and
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SANDOZ INC.
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Dated as of January 26, 2018
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TABLE OF CONTENTS
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PAGE
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	1.   DEFINITIONS.
	1

	2.   PURCHASE AND SALE OF PURCHASED ASSETS.
	5

	3.   ASSUMPTION OF LIABILITIES; RETAINED LIABILITIES.
	7

	4.   PURCHASE PRICE AND PAYMENT.
	9

	5.   CLOSING.
	9

	6.   REPRESENTATIONS AND WARRANTIES.
	10

	7.   INDEMNIFICATION.
	13

	8.   LIMITATION OF LIABILITY.
	14

	9.   INSURANCE.
	14

	10.   EXCLUSIVE REMEDIES.
	14

	11.   CONFIDENTIAL INFORMATION; PUBLICITY; USE OF CORPORATE NAMES.
	15

	12.   REGULATORY MATTERS.
	16

	13.   TRANSFER TAXES.
	17

	14.   NON-COMPETE.
	17

	15.   POST-CLOSING NEGOTATIONS.
	18

	16.   FURTHER ASSURANCES; TECHNICAL TRANSFER ACTIVITIES.
	18

	17.   MISCELLANEOUS.
	19

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INFORMATION IN THIS EXHIBIT IDENTIFIED BY BRACKETS IS CONFIDENTIAL AND HAS BEEN EXCLUDED PURSUANT TO ITEM 601(B)(10)(IV) OF REGULATION S-K BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CASI PHARMACEUTICALS, INC. IF PUBLICLY DISCLOSED.
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*** TRIPLE ASTERISKS DENOTE OMISSIONS
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Executive Version
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ASSET PURCHASE AGREEMENT
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This Asset Purchase Agreement (this “Agreement”) is entered into as of January 26, 2018, by and between CASI Pharmaceuticals, Inc., a Delaware corporation, with offices at 9620 Medical Center Drive, #300, Rockville, Maryland 20850 (“Buyer”), and Sandoz Inc., a Colorado corporation, with offices at 100 College Road West, Princeton, New Jersey 08540 (“Seller”).
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RECITALS
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WHEREAS, Seller owns certain pharmaceutical products which have associated ANDAs (as defined below) as listed on Schedule 1.3 (collectively, the “Products”, as further defined below); and
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WHEREAS, Buyer wishes to purchase the Purchased Assets from Seller, all upon the terms and subject to the conditions hereinafter set forth.
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NOW, THEREFORE, in consideration of the foregoing premises and the representations, warranties, covenants and agreements herein contained, Seller and Buyer, intending to be legally bound, hereby agree as follows:
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1.                   DEFINITIONS. For the purposes of this Agreement, capitalized terms used herein have the meaning set forth below (the singular shall be interpreted to include the plural and vice versa, unless the context clearly dictates otherwise):
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1.1               “Affiliate” means, with respect to any Person named herein, any other Person that is controlled by, controls, or is under common control with the named Person. “Control” of a business entity means any of: (a) direct or indirect beneficial ownership of fifty percent (50%) or more of the voting interest in such entity, (b) the right to appoint fifty percent (50%) or more of the directors or management of such entity, or (c) the power to otherwise direct the management and policies of such entity.
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1.2               “Ancillary Agreements” means the Pharmacovigilance Agreement, Quality Agreement, Transition Agreement and any other agreements contemplated by or actually entered into by the Parties in connection with this Agreement and/or any of the foregoing agreements.
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1.3               “ANDAs” means the Abbreviated New Drug Applications pursuant to 21 U.S.C. §355(j) and regulations promulgated thereunder, and all amendments and supplements thereof as set forth on Schedule 1.3. Buyer hereby acknowledges and agrees that certain of the ANDAs have been filed with the FDA but have not received FDA approval, as indicated on Schedule 1.3.
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1.4               “API Provider List” means the list on Schedule 1.4 of each Person who provides active pharmaceutical ingredients to Seller with respect to the Products set forth on Schedule 1.4.
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1.5               “Assumed Liabilities” shall have the meaning ascribed to the term in Section 3.1 of this Agreement.
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1.6               “Bill of Sale” means a bill of sale to be executed and delivered by each Party on the Closing Date attached hereto in Exhibit A.
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1.7               “Business Day” means any day, other than Saturday, Sunday or other day on which commercial banks are authorized or required to close in New York, New York.
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1.8               “Cap” shall have the meaning ascribed to the term in Section 8.
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1.9               [***]
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1.10           “Claim” includes a claim, notice, demand, action, proceeding, litigation, prosecution, arbitration, investigation, judgment, award, damage, loss, cost, expense or liability however arising, whether present, unascertained, immediate, future or contingent, whether based in contract, tort or statute and whether involving a Third Party or a Party or otherwise.
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1.11           “Closing” shall have the meaning ascribed to the term in Section 5.1.

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1.12           “Closing Date” shall have the meaning ascribed to the term in Section 5.1.
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1.13           “Confidential Information” shall have the meaning ascribed to the term in Section 11.2 of this Agreement.
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1.14           “Contracts” means all contracts, leases, deeds, mortgages, licenses, instruments, notes, commitments, undertakings, indentures, joint ventures and all other agreements, commitments and arrangements, whether written or oral.
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1.15           “Data Room Materials” means (a) all the Records and (b) any other documents related to the Products, in each case, made available to Buyer for inspection in the electronic data room.
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1.16           “Deductible” shall have the meaning ascribed to the term in Section 8.
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1.17           “Encumbrance” means any mortgage, pledge, assessment, security interest, deed of trust, lease, lien, levy, charge or other encumbrance, or any conditional sale or title retention agreement or other agreement to give any of the foregoing in the future.
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1.18           “Excluded Assets” means any assets of any kind, nature, character or description (whether real, personal or mixed, whether tangible or intangible, whether absolute, accrued, contingent, fixed or otherwise, and wherever situated) that are not expressly included within the definition of Purchased Assets.
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1.19           “Excipient Vendor List” means the list set forth on Schedule 1.4 of each Person who supplies excipients to Seller with respect to the Products set forth on Schedule 1.4.
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1.20           “Expiration Date” shall have the meaning ascribed to the term in Section 6.3.
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1.21           “FDA” means the United States Food and Drug Administration and all divisions under its direct control or any successor organizations.
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1.22           “Fundamental Representations” shall have the meaning ascribed to the term in Section 6.3.
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1.23           “Governmental Entity” means any arbitrator, court, judicial, legislative, administrative, or regulatory agency, commission, department, board, or bureau or body or other government authority or instrumentality or any Person or entity exercising executive, legislative, judicial, regulatory, or administrative functions of or pertaining to government, whether foreign or domestic, whether federal, state, provincial, municipal, or other.
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1.24           “Governmental Order” means any order, writ, judgment, injunction, decree, stipulation, determination or award entered by or with any Governmental Entity.
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1.25           “Indemnitee” shall have the meaning ascribed to that term in Section 7.3.1.
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1.26           “Indemnitor” shall have the meaning ascribed to that term in Section 7.3.1.
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1.27           “Intellectual Property Agreements” means the agreements set forth on the “Schedule of Settlements” document in the electronic data room.
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1.28           “Law” means any statute, law, ordinance, regulation, rule, code, order, constitution, treaty, common law, Governmental Order, legally binding guidance documents, other requirement or rule of law of any Governmental Entity related to the development, registration, Manufacture, importation, distribution, sale or marketing of the Products in the Territory or any obligation under, or related to, this Agreement and the transactions contemplated herein, and those obligations applicable to the ANDAs.
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1.29           “Legal Proceeding” means any Claim, action, suit, case, litigation, proceeding, audit, charge, criminal prosecution, judicial, governmental or regulatory investigation, arbitration, mediation, hearing, alternative dispute resolution proceeding, administrative proceeding, opposition, cancellation, warning letter, or notice of violation.
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1.30           “Liabilities” means any and all debts, liabilities and obligations of any nature, whether accrued or fixed, absolute or contingent, matured or unmatured, or known or unknown, including those arising under Law or governmental action and those arising under any contract, arrangement, commitment or undertaking, or otherwise.
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1.31           “Losses” means all losses, costs, damages, judgments, settlements, interest, fees or expenses, including all reasonable attorneys’ fees, experts’ or consultants’ fees, expenses and costs.
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1.32           “Manufacture” and “Manufacturing” means, with respect to a particular Product, the manufacture and preparation of that Product and includes the manufacturing, processing, filling, formulating, testing (including in-process testing), holding and storing, packaging, labeling, quality control testing and release of such Product.
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1.33           “Manufacturing Process” means the process (or any step in the process) used or planned to be used by Seller (or any of its permitted Affiliates or subcontractors) for the Manufacture of Product.
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1.34           “Master Batch Record” means, for any Product, as applicable, the description of the Manufacturing Process for such Product as set forth in such Product’s ANDA, including, the list of Raw Materials, the standard operating procedures, work instructions to be applied in production, in-process controls, the quality standards (including in-process and release testing), analytical procedures and batch analysis data in electronic format, and acceptance criteria.
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1.35           “NDC” means a national drug code as issued by FDA.
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1.36           “Party” or “Parties” means Seller or Buyer, as applicable.
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1.37           “Permitted Encumbrance” means (a) Encumbrances for Taxes which are not yet due and payable or which are being contested in good faith by appropriate proceedings and for which appropriate reserves have been established in accordance with International Financial Reporting Standards, (b) statutory mechanics’, carriers’, workmen’s, landlords’ or other similar liens arising or incurred in the ordinary course of business which are not yet delinquent or the validity of which are being contested in good faith by appropriate proceedings, or (c) other Encumbrances that (i) are not Encumbrances on intellectual property and (ii) that are incurred in the ordinary course of business that, individually and in the aggregate, do not and would not reasonably be expected to materially detract from the value or impair the use of the property subject thereto or make such property unmarketable.
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1.38           “Person” means any individual, partnership (general or limited), association, corporation, limited liability company, joint venture, trust, estate, limited liability partnership, unincorporated organization, government (or any agency or political subdivision thereof) or other legal person or organization.
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1.39           “Pharmacovigilance Agreement” means the agreement related to the Products attached hereto as Exhibit B.
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1.40           “Product(s)” means any pharmaceutical products that are Manufactured, promoted, offered for sale or sold pursuant to any of the ANDAs.
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1.41           “Purchase Price” shall have the meaning ascribed to that term in Section 4.1.1 of this Agreement.
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1.42           “Purchased Assets” means all Seller’s right, title and interest in the (a) ANDAs on Schedule 1.3; (b) Data Room Materials and, without duplication, any other Records; (c) Sample Products, including the applicable commercial package and labeling; (d) the Raw Materials set forth on Schedule 1.44; and (e) such Intellectual Property Agreements as are transferred to Buyer in accordance with Section 2.4. The “Purchased Assets” shall not include any Excluded Assets.
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1.43           “Quality Agreement” means the agreement related to the Products attached hereto as Exhibit C.
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1.44           “Raw Materials” means the active pharmaceutical ingredients (API) to the extent set forth on Schedule 1.44.
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1.45           “Records” means copies of: (a) the existing ANDAs, (b) material, official, written correspondence with FDA specifically related to the review and approval of any Product, (c) annual reports, CBE 0, CBE 30 and Prior Approval Supplements (PAS), in each case, specifically related to the ANDAs, (d) warning letters and responses related to the ANDAs, (e) periodic adverse event reports (PADER) specifically relating to the Products in the possession of Seller as of the Closing Date, (f) FDA Approval Letters issued pursuant to 21 U.S.C. §355(j) with respect to the ANDAs, as applicable, (g) Master Batch Records, process validation protocols, SOPS, scale-up and equipment information (h) chemistry, manufacturing and control (CMC) data related to the Products, which shall be produced in ECTD format to the extent such data is available in such format and (i) the Technical Transfer Documentation; provided, however, that “Records” shall not include any pricing or financial information related to the distribution of the Products or any agreements with customers.
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1.46           “Retained Liabilities” has the meaning ascribed to the term in Section 3.2.

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1.47           “Restricted Period” has the meaning ascribed to the term in Section 14.1.
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1.48           “Sample Product(s)” means the number of units of certain Product, in one case, as set forth on Schedule 1.48.
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1.49           “SEC” shall have the meaning ascribed to that term in Section 11.3.
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1.50           “Seller’s Knowledge” shall mean [***] knowledge [***] of the Seller or its Affiliate’s employees whose names are set forth on Schedule 1.50 attached hereto. “Seller’s Knowledge” shall not: (a) be construed to refer to the knowledge of any other officer, director, employee, representative or agent of the Seller, or any Affiliate of Seller or (b) to impose upon such employees listed on Schedule 1.50 any individual personal liability.
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1.51           “Seller Distribution Term” means the period starting on the Closing Date and ending on (a) the date that is [***] months after the Closing Date for all Products except the [***] and (b) with respect to the [***], the date that is [***] months after the Closing Date.
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1.52           “Taxes” means taxes, duties, fees, premiums, assessments, imposts, levies and other charges of any kind whatsoever imposed by any Governmental Entity, including all interest, penalties, fines, additions to tax or other additional amounts imposed by any Governmental Entity in respect thereof, and including those levied on, or measured by, or referred to as, income, gross receipts, profits, capital, transfer, land transfer, sales, goods and services, harmonized sales, use, value-added, excise, stamp, withholding, business, franchising, property, development, occupancy, employer health, payroll, employment, health, social services, education and social security taxes, all surtaxes, all customs duties and import and export taxes, countervail and anti-dumping, all license, franchise and registration fees and all employment insurance, health insurance and government pension plan premiums or contributions.
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1.53           “Technical Transfer Documentation” means the documentation listed in Exhibit G.
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1.54           “Territory” means the fifty states of the United States of America, the District of Columbia, the Commonwealth of Puerto Rico, Guam, American Samoa, the U.S. Virgin Islands and all territories and possessions of the United States of America and United States military bases. For the avoidance of doubt, subsequent to the Closing and subject only to Section 2.3, Buyer shall own the rights to all of the Purchased Assets worldwide.
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1.55           “Third Party” means any Person other than Seller, Buyer or their respective Affiliates.
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1.56           “Transition Agreement” means the agreement attached hereto as Exhibit F.
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2.                   PURCHASE AND SALE OF PURCHASED ASSETS.
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2.1               Purchase and Sale of Assets. Subject to the terms and conditions of this Agreement, at the Closing Date, Seller shall sell, transfer, convey, assign and deliver to Buyer, free and clear of all Encumbrances, and Buyer shall purchase, acquire and accept from Seller, all of Seller’s right, title and interest, as of the Closing, in and to the Purchased Assets.
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2.2               Excluded Assets and Retention of Certain Information. Notwithstanding anything herein to the contrary, (a) from and after the Closing Date, Seller and its Affiliates shall retain all their right, title and interest in and to the Excluded Assets, and (b) Seller and its Affiliates may, with respect to the Purchased Assets, retain copies of the ANDAs and all Data Room Materials which, following the Closing Date, may be used only as contemplated in this Agreement or any Ancillary Agreement and as required to comply with Laws, subject to Seller’s confidentiality obligations hereunder.
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2.3               Limitation of Use of Certain Purchased Assets.
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2.3.1                Notwithstanding anything herein to the contrary, Buyer agrees that it shall not have the right to utilize, or license or transfer to any other Person the Sample Products or the sample packaging and labeling included in the Purchased Assets for any purpose other than in connection with regulatory or research and development efforts in connection with the Products. In no event shall Buyer have the right to, directly or indirectly, use any of the Sample Products (a) in human beings or (b) for any commercial purpose.
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2.3.2                Notwithstanding anything herein to the contrary, Buyer agrees that [***].
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2.4               Intellectual Property Agreements. After the Closing Date, Seller shall use commercially reasonable efforts to obtain written consents that would permit Seller to assign the Intellectual Property Agreements to Buyer.  In the event that Seller obtains such consent as to an Intellectual Property Agreement, Seller shall provide written notice to Buyer that it has received such consent. Unless Buyer informs Seller within [***] Business Days of receipt of such notice that Buyer rejects the assignment of such Intellectual Property Agreement, at such time as the Seller Distribution Term terminates, Buyer and Seller shall execute an assignment agreement substantially in the form attached hereto in Exhibit D and such Intellectual Property Agreement shall be deemed a Purchased Asset as of such time. If Seller is not able to obtain any such written consent(s) or Buyer rejects the assignment of any Intellectual Property Agreement, then Buyer hereby acknowledges that Seller shall not be in breach of this provision with respect to such Intellectual Property Agreement and all Liabilities associated with such Intellectual Property Agreement shall remain Retained Liabilities.
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2.5               Appointment of Seller As Distributor.
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2.5.1                Beginning on the Closing Date and continuing until the end of the Seller Distribution Term, subject to the other terms of this Section 2.5 below, Seller, either directly or through its Affiliates, shall have the right (but not the obligation) to market, have marketed, distribute, have distributed, offer to sell, sell, commercialize, have commercialized and otherwise exploit (collectively, for purposes of this Section 2.5, “Distribute”) the applicable Products to its Third Party customers, [***]; provided, that, notwithstanding anything to the contrary in this Agreement, Seller does not currently have and shall not be required to maintain field force promotion of the Products.
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2.5.2                Notwithstanding the foregoing, Seller may only Distribute, during the Seller Distribution Term, to Third Party customers [***]. On and after the Closing Date, Seller is authorized to Manufacture any Products to the extent necessary to allow Seller to perform under this Section 2.5; provided, however, that Seller shall send written notice to Buyer of any Products and amounts so Manufactured.
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2.5.3                [***] shall be responsible for [***] Liabilities and for [***] economic benefits or losses arising from [***] under this Section 2.5. [***] shall be responsible for the payment of any sales or other Taxes and rebates relating to the provision of goods or services with respect to any Products distributed pursuant to this Section 2.5.
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2.5.4                Notwithstanding the foregoing, during the Seller Distribution Term, Buyer shall have the right (but not the obligation) to engage in any discussions or negotiations with any Third Parties for such Third Parties to Distribute the Products following the end of the Seller Distribution Term; provided, that, Buyer shall not be permitted to execute any definitive agreements for such Distribution rights with any such Third Parties that have an effective date beginning prior to the end of such Seller Distribution Term. Notwithstanding the foregoing: (i) [***]; and (ii) in the event that [***], Seller shall use commercially reasonable efforts to notify Buyer within ten (10) Business Days after such cessation, and after Buyer’s receipt of such notice, Buyer shall no longer be restricted from executing any definitive agreements with Third Parties to Distribute such Product.
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2.5.5                Seller shall Distribute Products under this Section 2.5: (a) in substantially the [***]; and (b) in accordance with applicable Laws. [***] shall be [***] responsible to [***] for all errors, omissions and delays in [***] Distribution of Products and all Liabilities related to [***] Distribution of Products under this Section 2.5, or [***] failure to Distribute Products in accordance with this Section 2.5.
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2.5.6                Subject to the terms and conditions contained herein, during the Seller Distribution Term, the Parties shall use good faith efforts to cooperate with each other in the Distribution of Products and shall use reasonable efforts to exchange information specifically related to the Distribution of Products pursuant to this Section 2.5 (such information exchange shall not include any type of pricing information and shall be subject to Seller’s confidentiality obligations to any Person, including Seller’s customers).
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2.5.7                Buyer shall be entitled to terminate Seller’s rights under this Section 2.5 upon Seller’s material breach of the provisions of this Agreement; provided, however, that Buyer may only terminate this Section 2.5 under this Section 2.5.7 if such breach is not cured within [***] days following Buyer’s notice to Seller of such breach.
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2.5.8                For the avoidance of doubt, nothing contained in this Agreement shall give Buyer any right, directly or indirectly, to use the Sandoz Names and Marks (defined below).  “Sandoz Names and Marks” means the corporate mark, trade mark, house mark, trade name and trade dress, including the name Sandoz and any variants thereof, product identification numbers (including NDCs), and consumer information telephone numbers appearing on the Product labelling.
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3.                   ASSUMPTION OF LIABILITIES; RETAINED LIABILITIES.
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3.1               Assumed Liabilities. Subject to the terms and conditions of this Agreement and of any Ancillary Agreement, Buyer agrees, effective as of the Closing Date, to assume the following Liabilities of Seller and its Affiliates relating to the Purchased Assets, (all such Liabilities being collectively referred to herein as “Assumed Liabilities”):
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3.1.1                any Liabilities, commitments or obligations to any Governmental Entity first arising on or after the Closing Date in connection with the Purchased Assets or the Products sold on or after Closing Date (other than Liabilities arising out of any sales made by Seller and its Affiliates following the Closing pursuant to Section 2.5 of this Agreement, unless any such Liability arises out of Buyer’s negligence, misconduct or breach of this Agreement or any Ancillary Agreement, in which case such Liability shall be treated as an Assumed Liability);
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3.1.2                all Liabilities for Taxes arising out of or relating to ownership, use or sale by or on behalf of Buyer or its Affiliates of the Purchased Assets in any taxable period, or a portion thereof, beginning on or
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after the Closing Date (other than Taxes arising out of any sales made by Seller and its Affiliates following Closing pursuant to Section 2.5 of this Agreement);
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3.1.3                all Liabilities arising out of or relating to any Legal Proceedings commenced on or after the Closing Date, irrespective of the legal theory asserted, arising from the Purchased Assets or the Manufacture, advertising, marketing, distribution, sale or use of the Products by or on behalf of Buyer or its Affiliates (other than Liabilities arising out of any sales made by Seller and its Affiliates following Closing pursuant to Section 2.5 of this Agreement, unless any such Liability arises out of Buyer’s negligence, misconduct or breach of this Agreement or any Ancillary Agreement, in which case such Liability shall be treated as an Assumed Liability);
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3.1.4                all Liabilities arising out of or relating to any return of the Products sold by or on behalf of Buyer or its Affiliates on or after the Closing Date (other than Liabilities arising out of any sales made by Seller and its Affiliates following Closing pursuant to Section 2.5 of this Agreement, unless any such Liability arises out of Buyer’s negligence, misconduct or breach of this Agreement or any Ancillary Agreement, in which case such Liability shall be treated as an Assumed Liability);
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3.1.5                any and all Liabilities and obligations of the Buyer that arise on or after the Closing Date out of or related to the Purchased Assets or Products under Sections 12.2 and 12.3 of this Agreement;
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3.1.6                in the event the Intellectual Property Agreements are assigned by Seller to Buyer pursuant to Section 2.4 above, all Liabilities related to the Intellectual Property Agreements assumed by the Buyer arising on or after the date of such assignment (other than Liabilities arising out of any sales made by Seller and its Affiliates following the date of such assignment pursuant to Section 2.5 of this Agreement, unless any such Liability arises out of Buyer’s negligence, misconduct or breach of this Agreement or any Ancillary Agreement, in which case such Liability shall be treated as an Assumed Liability); and
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3.1.7                any and all other Liabilities and obligations that arise out of or are related to the Purchased Assets or Products attributable to occurrences and circumstances arising on or after the Closing Date (other than any Liabilities or obligations related to any sales made by Seller and its Affiliates following Closing pursuant to Section 2.5 of this Agreement, unless any such Liability arises out of Buyer’s negligence, misconduct or breach of this Agreement or any Ancillary Agreement, in which case such Liability shall be treated as an Assumed Liability).
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3.2               Retained Liabilities. Subject to the terms and conditions of this Agreement and of any Ancillary Agreement, other than the Assumed Liabilities, Seller and its Affiliates shall retain and be responsible for the following, except, in each case, to the extent such Liability arises out of Buyer’s negligence, misconduct or breach of this Agreement or any Ancillary Agreement (in which case such Liability shall be treated as an Assumed Liability) (collectively, “Retained Liabilities”):
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3.2.1                all Liabilities arising out of or relating to any Legal Proceedings commenced before or after the Closing Date, irrespective of the legal theory asserted, arising from the Manufacture, advertising, marketing, distribution, sale or use of the Products before the Closing Date;
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3.2.2                all Liabilities arising out of or relating to any Legal Proceedings commenced after the Closing Date, irrespective of the legal theory asserted, arising from any sales of Products by Seller or its Affiliates following Closing Date pursuant to Section 2.5 of this Agreement;
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3.2.3                all Liabilities arising out of or relating to any return of the Products sold by Seller or its Affiliates either (a) before the Closing Date or (b) on or after the Closing Date pursuant to Section 2.5 of this Agreement;
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3.2.4                all other Liabilities and obligations that arise out of or are related to the Purchased Assets or Products attributable to occurrences and circumstances arising (a) before the Closing Date; or (b) on or after the Closing Date related to any Manufacture of Products by Seller or its Affiliates or sales made by Seller and its Affiliates following the Closing Date pursuant to Section 2.5 of this Agreement;
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3.2.5                all Liabilities for Taxes (a) arising out of or relating to the ownership of the Purchased Assets in any taxable period, or a portion thereof, prior to the Closing Date; (b) arising out of any Product sales made by Seller or its Affiliates to Third Parties following the Closing Date pursuant to Section 2.5 of this Agreement; or (c) relating to any activity of Seller or its Affiliates unrelated to the Purchased Assets;
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3.2.6                all Liabilities to the extent arising from the Excluded Assets;
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3.2.7                all Liabilities under the Intellectual Property Agreements resulting from Seller’s breach of such Intellectual Property Agreements prior to the date of assignment, if any, of such Intellectual Property Agreement pursuant to Section 2.4 above;
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3.2.8                all Liabilities arising out of any of Seller’s Contracts with Third Parties that are specific to the Products; and
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3.2.9                all other Liabilities arising out of or relating to the Purchased Assets to the extent such Liabilities relate to the period prior to the Closing Date.
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The Parties agree that neither Buyer nor any of its Affiliates shall assume or be deemed to have assumed any Retained Liabilities.
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4.                   PURCHASE PRICE AND PAYMENT.
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4.1               Purchase Price. As consideration for the Purchased Assets and Seller’s full and faithful performance of all its obligations hereunder, Buyer shall at Closing:
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4.1.1                pay to Seller by wire transfer of immediately available funds an amount equal to Eighteen Million US Dollars ($18,000,000) (the “Purchase Price”); and
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4.1.2                assume the Assumed Liabilities.
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5.                   CLOSING.
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5.1               Time and Place. The closing of the transactions contemplated by this Agreement, including the purchase and sale of the Purchased Assets and the assumption of the Assumed Liabilities (the “Closing”), shall take place remotely via the exchange of documents and signature pages on the date hereof (the “Closing Date”).
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5.2               Deliveries at Closing.
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5.2.1                Closing Deliveries by Seller. At the Closing, Seller shall deliver or cause to be delivered to Buyer:
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5.2.1.1          the Bill of Sale executed by Seller;
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5.2.1.2          one (1) physical and / or electronic copy (as available) of each of the ANDAs on Schedule 1.3 and the Data Room Materials for the ANDAs (except that certain of the Technical Transfer Documentation will be delivered in accordance with Section 16.1.2);
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5.2.1.3          the Pharmacovigilance Agreement executed by Seller;
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5.2.1.4          the Transition Agreement executed by Seller; and
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5.2.1.5          the Quality Agreement executed by Seller.
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5.2.2                Closing Deliveries by Buyer. At the Closing, Buyer shall deliver or cause to be delivered to Seller:
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5.2.2.1          the Bill of Sale executed by Buyer;
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5.2.2.2          the Purchase Price;
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5.2.2.3          the Pharmacovigilance Agreement executed by Buyer;
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5.2.2.4          the Transition Agreement executed by Buyer; and
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5.2.2.5          the Quality Agreement executed by Buyer.
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6.                   REPRESENTATIONS AND WARRANTIES.
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6.1               Mutual Representations and Warranties. Each of the Parties represents and warrants to the other Party that:
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6.1.1                such Party has the corporate power and authority to enter into this Agreement and to consummate the transactions contemplated hereby;
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6.1.2                neither the execution and delivery of this Agreement or the Ancillary Agreements by such Party, nor its performance hereunder, conflicts with or will result in any violation or breach of, or constitutes (with or without due notice or lapse of time or both) a default under any of the terms or conditions of the organizational documents of such Party nor any note, indenture, license, agreement or other instrument or obligation to which it is a party or by which it or any of its properties or assets may be bound; or to the best of Seller’s Knowledge, violates any Law;
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6.1.3                this Agreement is a legal, valid and binding agreement of such Party, enforceable in accordance with its terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent transfer and other similar laws affecting creditors’ rights generally from time to time in effect and to general principles of equity (including concepts of materiality, reasonableness, good faith and fair dealing), regardless of whether considered in a proceeding in equity or at law;
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6.1.4                such Party has not, and will not, directly or indirectly, enter into any Contract or any other transaction with any Third Party that conflicts or derogates from its undertakings hereunder; and
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6.1.5                such Party (a) has never been, and its employees involved in the development and approval of any Product had not been during their term of employment with Seller, debarred, suspended, or convicted of a crime for which a person can be debarred or suspended under 21 U.S.C. § 335a (“335a”), nor to Seller’s Knowledge, threatened in writing to be debarred, suspended, or indicted for a crime or otherwise engaged in conduct for which a person can be debarred or suspended under 21 U.S.C. § 335a; (b) agrees that it will promptly notify such other Party in the event of any such debarment, suspension, conviction, threat, or indictment of any employee performing under this Agreement that occurs during the Seller Distribution Term; and (c) agrees not to employ any person in connection with the performing under this Agreement who has been debarred, suspended, or convicted of a crime for which a person can be debarred, suspended, or threatened to be debarred, suspended, or indicted for a crime for which a person can be debarred or suspended under 335a.
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6.2               Seller Representations and Warranties. Seller represents and warrants to Buyer as of the Closing Date that:
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6.2.1                Title. Seller has good and marketable title to the Purchased Assets, free and clear of all Encumbrances (other than Permitted Encumbrances).
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6.2.2                Seller Intellectual Property.
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6.2.2.1          [***].
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6.2.2.2          Except as set forth on Schedule 6.2.2.2, there have been and are no Legal Proceedings (including any oppositions, interferences or re-examinations) settled, pending or, to Seller’s Knowledge, threatened in writing (including in the form of offers to obtain a license), alleging that the Products infringe, misappropriate, dilute or otherwise violate the intellectual property of any Person in the Territory; nor to Seller’s Knowledge is there any basis for such a Legal Proceeding.
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6.2.2.3          The financial information provided by Seller to Buyer in electronic form via the Data Room [***]. The other documentation relating to the Products and included in the Data Room Materials is current, [***], and such documentation will be in tangible form as part of the Purchased Assets of the Closing.
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6.2.3                Legal Proceedings; Governmental Orders.
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6.2.3.1          Other than as set forth in Schedule 6.2.3.1, there are no Legal Proceedings pending or, to Seller’s Knowledge, threatened in writing against Seller or any Affiliate (a) specifically relating to the Purchased Assets; or (b) that challenge or seek to prevent, enjoin or otherwise delay the transactions contemplated by this Agreement.
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6.2.3.2          Other than as set forth in Schedule 6.2.3.2, in the [***] years prior to the Closing Date, none of the Products, nor the commercialization or distribution thereof by Seller or its Affiliates, was previously the subject of any Legal Proceeding brought, or, to Seller’s Knowledge, threatened in writing against Seller or any Affiliate, except as would not be reasonably expected to have a material adverse effect on the Purchased Assets.
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6.2.3.3          To Seller’s Knowledge, there are no outstanding Governmental Orders and no unsatisfied judgments, penalties or awards against, relating to or affecting the Purchased Assets.
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6.2.4                Compliance With Laws.
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6.2.4.1          To Seller’s Knowledge, Seller is in compliance, in all material respects with all Laws applicable to Seller’s ownership and use of the Purchased Assets, except as would not be reasonably expected to have a material adverse effect on the Purchased Assets.
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6.2.4.2          Other than [***], to Seller’s Knowledge, no regulatory approvals are necessary for the development, Manufacture, commercialization or distribution of the Products within the Territory. As used herein, [***] means the [***] and all divisions under its direct control or any successor organizations.
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6.2.4.3          Seller has delivered to Buyer a full and complete copy of the approved ANDA for each Product, including supplements and records that are required to be kept pursuant to 21 C.F.R. § 314.81. Through the Closing, Seller has paid all fees and made all communications with FDA or other Governmental Entities as required by Law in respect of the ANDAs. Seller has paid all fees due and owing for periods through the Closing under Generic Drug User Fee Amendments of 2012 and has filed all required reports (including adverse drug experience reports) with the appropriate Governmental Entities.
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6.2.4.4          API Providers and Excipient Vendors. Schedule 1.4 contains an accurate and complete list of each Person who provides active pharmaceutical ingredients to Seller with respect to any of the Products. Schedule 1.4 also contains an active and complete list of each Person who supplies excipients to Seller with respect to any of the Products. The Data Room Materials includes, to the best of Seller’s Knowledge, Seller’s latest contact information for such Persons.
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6.2.5                No Recalls. During the [***] years prior to the Closing Date, other than as set forth in Schedule 6.2.5, none of the Products sold by Seller have been the subject of any recalls, withdrawals or field corrections, and Seller has not received any written notice from a Government Entity requiring, nor, to Seller’s Knowledge, is there a factual basis for Seller or a Government Entity to initiate or require, such a recall, withdrawal or field correction of any of the Products.
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6.3               Survival of Representations and Warranties. All representations and warranties of Seller and Buyer contained herein or made pursuant hereto shall survive the Closing Date and shall remain operative and in full force and effect for a period of [***] following the Closing Date (the “Expiration Date”); provided however, that the representations and warranties in [***], [***], and [***] (collectively, the “Fundamental Representations”) shall survive the Closing Date and shall remain operative and in full force and effect for a period of [***] following the Closing Date. Notwithstanding anything herein to the contrary, any breach of a representation or warranty that is the subject of a claim that is asserted in writing prior to the Expiration Date shall survive with respect to such claim or any dispute with respect thereto until the final resolution thereof.
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6.4               EXCEPT AS EXPRESSLY SET FORTH HEREIN, SELLER IS NOT MAKING AND HEREBY EXPRESSLY DISCLAIMS, ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR TITLE OR NONINFRINGEMENT, WITHOUT DEROGATING FROM THE GENERALITY OF THE FOREGOING, BUYER ACKNOWLEDGES AND AGREES THAT EXCEPT AS EXPRESSLY SET FORTH HEREIN SELLER IS SELLING THE PURCHASED ASSETS ON AN “AS IS” AND “WHERE IS” BASIS AND SELLER MAKES NO OTHER REPRESENTATION OR WARRANTY WITH RESPECT TO THE PURCHASED
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ASSETS OR THE PRODUCTS INCLUDING, WITHOUT LIMITATION, ANY GUARANTEE THAT FDA APPROVAL WILL BE OBTAINED OR MAINTAINED, RELATING TO THE MANUFACTURE AND/OR MARKETING OF ANY PRODUCTS.
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6.5               Adequacy of Information. Buyer acknowledges and agrees that:
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6.5.1                it has been furnished with or given adequate access to the information about the Purchased Assets and Product as it has requested;
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6.5.2                it has carried out due diligence concerning the Purchased Assets and Products and is making its own independent evaluation of the Purchased Assets and Products; and
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6.5.3                Seller makes no warranty with respect to the accuracy and completeness of any estimates, projections, forecasts, plans, or budgets provided by Seller to Buyer.
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6.6               Buyer Representations and Warranties. Buyer represents and warrants to Seller as of the Closing Date that Buyer has sufficient cash on hand to enable it to make payment of the Purchase Price pursuant to Section 4.1.
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7.                   INDEMNIFICATION.
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7.1               Buyer’s Indemnification Obligations. Buyer shall indemnify, defend and hold Seller and its Affiliates and their respective officers, directors, employees, agents and subcontractors harmless from and against any and all Losses arising out of or resulting from any Claims made or suits brought against such parties which arise or result from (a) Buyer’s breach of any of its representations or warranties set forth in Section 6 of this Agreement; (b) Buyer’s breach of any the covenants in this Agreement or any Ancillary Agreement, or any of its obligations hereunder or thereunder; or (c) any and all Assumed Liabilities.
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7.2               Seller’s Indemnification Obligations. Seller shall indemnify, defend and hold Buyer and its Affiliates and their respective officers, directors, employees, agents and subcontractors harmless from and against any and all Losses arising out of or resulting from any Claims made or suits brought against such parties which arise or result from (a) Seller’s breach of any of its representation or warranties set forth in Section 6 of this Agreement, (b) Seller’s breach of any of its covenants in this Agreement or any Ancillary Agreement, or any of its obligations hereunder or thereunder; (c) any and all Retained Liabilities; or (d) [***].
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7.3               Indemnification Procedure.
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7.3.1                No claim for indemnification hereunder shall be valid unless notice of the matter which may give rise to such claim is given in writing by the indemnitee (the “Indemnitee”) to the Party against whom indemnification may be sought (the “Indemnitor”) as soon as reasonably practicable after such Indemnitee becomes aware of such claim; provided, however, that the failure to notify the Indemnitor shall not relieve it from any liability that it may have to the Indemnitee otherwise unless the Indemnitor demonstrates that the defense of the underlying Claim has been materially prejudiced by such failure to provide timely notice. Such notice shall request indemnification and describe the potential Losses and Claim giving rise to the request for indemnification, and provide, to the extent known and in reasonable detail, relevant details thereof. If the Indemnitor fails to give Indemnitee notice of its intention to defend any such Claim as provided in this Section within [***] Business Days of receiving notice thereof the Indemnitee involved shall have the right to assume the defense thereof with counsel of its choice, at the Indemnitor’s expense, and defend, settle or otherwise dispose of such Claim with the consent of the Indemnitor, not to be unreasonably withheld or delayed.
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7.3.2                In the event the Indemnitor elects to assume the defense of a Claim, the Indemnitee of the Claim in question and any successor thereto shall permit Indemnitor’s counsel and independent auditors, to the extent relevant, reasonable access to its books and records and otherwise fully cooperate with the Indemnitor in connection with such Claim; provided, however, that (a) the Indemnitee shall have the right fully to participate in such defense at its own expense; (b) the Indemnitor’s counsel and independent auditors shall not disclose any Confidential Information of the Indemnitee to the Indemnitor without the Indemnitee’s consent; (c) access shall only be given to the books and records that are relevant to the Claim or Losses at issue. The defense by the Indemnitor of any such actions shall not be deemed a waiver by the Indemnitee of its right to assert a claim with respect to the responsibility of the Indemnitor with respect to the Claim or Losses in question. The Indemnitor shall have the right to settle or compromise any Claim against the Indemnitee (that the Indemnitor has defended pursuant to this Section 7.3.2) without the consent of the Indemnitee provided that the terms thereof: [***]. No Indemnitee shall pay or voluntarily permit the determination of any Losses which is subject to any such Claim while the Indemnitor is negotiating the settlement thereof or contesting the matter, except with the prior written consent of the Indemnitor, which consent shall not be unreasonably withheld or delayed.
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8.                   LIMITATION OF LIABILITY. Notwithstanding anything herein to the contrary, Seller shall not have any indemnification obligations for any individual Losses arising from or in connection with the indemnification obligations in Section [***] unless and until the aggregate amount of all such Losses for which such Seller shall be responsible exceeds [***] (the “Deductible”), in which event Seller shall be required to pay the full amount of such Losses to the extent exceeding the Deductible, but only up to a maximum aggregate amount equal to [***] (the “Cap”). Neither the Deductible nor the Cap shall apply to the indemnification obligations under Section [***] that arise out of the Seller’s breach of the representations or warranties set forth in the Fundamental Representations; provided, however, that Seller’s maximum aggregate liability for indemnification obligations under Section [***] that arise out of the Seller’s breach of the Fundamental Representations shall in no event exceed [***].
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9.                   INSURANCE. At all times from the first commercial sale of any Product(s) by Buyer on or after the Closing Date through the date which is [***] after the final sale of such Product(s), Buyer will maintain product liability and other insurance (or self-insurance) for itself in amounts which are reasonable and customary in the United States pharmaceutical industry, provided in no event shall the product liability insurance amounts be less than [***] per occurrence and [***] in the aggregate limit of liability per year. Buyer shall provide written proof of such insurance to Seller upon request.
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10.               EXCLUSIVE REMEDIES. Other than with respect to claims for fraud or willful misconduct by a Person, following the Closing, the sole and exclusive remedy for any and all Claims arising under, out of, or related to this Agreement and the other Ancillary Agreements and the transactions contemplated hereby and thereby shall be the rights of indemnification set forth in Section 7 only, and no Person will have any other entitlement, remedy or recourse, whether in contract, tort or otherwise, it being agreed that all of such other remedies, entitlements and recourse are expressly waived and released by the Parties hereto to the fullest extent permitted by Law.
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11.               CONFIDENTIAL INFORMATION; PUBLICITY; USE OF CORPORATE NAMES.
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11.1           Confidential Information. Each Party agrees that at and after the Closing, it shall not, without the prior written consent of the other Party, (a) disclose to any Person such other Party’s Confidential Information (as defined below), except to those of its and its Affiliates’ employees or representatives who need to know such information for the purpose of exploiting its rights or fulfilling its obligations under this Agreement or any Ancillary Agreement (and then only to the extent that such persons are under an obligation to maintain the confidentiality of the Confidential Information), or (b) use any of such other Party’s Confidential Information for any reason other than as contemplated by this Agreement or any Ancillary Agreement. If a Party has been advised by legal counsel that disclosure of Confidential Information of the other Party is required to be made under Law (including the requirements of a national securities exchange or another similar regulatory body) or pursuant to documents subpoena, civil investigative demand, interrogatories, requests for information, or other similar process, the Party required to disclose the Confidential Information shall (to the extent legally permitted) provide the other Party with prompt written notice of such request or demands or other similar process so that such other Party may seek an appropriate protective order or waive the disclosing Party’s compliance with the provisions of this Section. In the absence of a protective order or waiver or other remedy, the Party required to disclose the other Party’s Confidential Information may disclose only that portion of the Confidential Information that its legal counsel advises it is legally required to disclose, provided that it exercises its commercially reasonable efforts to preserve the confidentiality of such other Party’s Confidential Information, at such other Party’s expense, including by cooperating with such other Party to obtain an appropriate protective order or other reliable assurance that confidential treatment will be accorded the Confidential Information. On or after the Closing Date, the Purchased Assets and all Confidential Information related solely to the Purchased Assets (other than this Agreement or any Ancillary Agreement) shall be considered the Confidential Information of Buyer under this Section 11.1 and the obligations of this Section 11.1 shall apply to the Seller and not the Buyer; provided however, that to the extent such Confidential Information is also used by the Seller in the Retained Liabilities or Excluded Assets or in fulfilling obligations under this Agreement or any Ancillary Agreement, such Confidential Information shall constitute the Confidential Information of both Parties.
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11.2           The term “Confidential Information” as used in this Agreement means (a) as to Buyer, all confidential information exclusively relating to Buyer’s business, this Agreement and the Ancillary Agreements, and their respective terms, and the Purchased Assets and the Assumed Liabilities, or other business information provided by Buyer to Seller as contemplated by this Agreement or any Ancillary Agreement and (b) as to Seller, all confidential information relating to the business and operations of Seller, including this Agreement and its terms, and (except as otherwise provided in Section 11.1) the Excluded Assets and the Retained Liabilities or other obligations other than the Assumed Liabilities. The term “Confidential Information” does not include information that (i) becomes generally available to the public other than as a result of disclosure by the disclosing Party, (ii) becomes available to the disclosing Party on a non-confidential basis from a source other than the non-disclosing Party, provided that such source is not known by the disclosing Party to be bound by a confidentiality agreement with the non-disclosing Party, or (iii) other than information that comprises the Purchased Assets, was previously known by the non-disclosing Party as evidenced by the non-disclosing Party’s written records.
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11.3           Public Announcement. Neither Seller, Buyer nor any of their respective Affiliates shall issue any press release or make any public announcement with respect to this Agreement or any Ancillary Agreement and the transactions contemplated hereby or thereby without obtaining the prior written consent of the other Party, except as may be required by Law, including any federal or state securities law, upon the advice of legal counsel and only if the disclosing Party (a) provides the non-disclosing Party with an opportunity to first review the release or other public announcement, (b) consults with the non-disclosing Party (whether such Party is named in such publicity, news release or public announcement or not) at a reasonable time prior to its release to allow the non-disclosing Party to comment thereon and (c) after its release, shall provide the non-disclosing Party with a copy thereof. If a Party, based on the advice of its legal counsel, determines that this Agreement or any Exhibits hereto must be filed with the United States Securities and Exchange Commission (“SEC”), then such Party, prior to making any such filing, shall provide the
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other Party and its legal counsel with a redacted version of this Agreement which it intends to file and any draft correspondence with the SEC requesting the confidential treatment by the SEC of those redacted sections of this Agreement, and will give due consideration to any timely comments provided by such other Party or its legal counsel and use reasonable efforts to ensure the confidential treatment by the SEC of those sections specified by such other Party or its legal counsel. Following the Closing, Buyer shall be entitled to make such public announcements as it deems appropriate related to Products; provided however that except as otherwise provided above, without Seller’s prior written consent, no such announcement shall contain any reference to this Agreement or any Ancillary Agreement or the terms set forth herein or therein or Seller, its Affiliates or actions taken with respect to Products prior to the Closing Date other than references materially consistent with those previously approved by Seller.
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12.               REGULATORY MATTERS.
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12.1           Transfer of ANDAs. Buyer and Seller shall use commercially reasonable efforts to effectuate the transfer of the ANDAs included in the Purchased Assets, at Buyer’s sole cost and expense, as of or as promptly as possible after the Closing Date, pursuant to the procedures for changing the ownership of an ANDA set forth at 21 C.F.R. § 314.72.
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12.1.1            Within five (5) Business Days after the Closing Date, Seller shall submit letter(s) to FDA in substantially the form set forth in Exhibit E. In its letter(s), Seller shall state the rights to the ANDAs included in the Purchased Assets have been transferred to Buyer. Within five (5) Business Days following the date that Seller notifies Buyer that Seller has submitted the letter(s) referenced above, Buyer shall submit letter(s) to FDA in substantially the form set forth in Exhibit E. In its letter(s), Buyer shall state: (a) its commitment to agreements, promises, and conditions made by Seller and contained in the ANDAs; (b) the date that the change in ownership is effective; and (c) a statement that the Buyer has a complete copy of the approved application, including supplements and records that are required to be kept pursuant to 21 C.F.R. § 314.81.
​
12.2           Assumption of Regulatory Responsibilities. From and after the Closing Date, Buyer, at its sole cost and expense, shall be solely responsible and liable for taking all actions, paying all fees and conducting all communications with FDA (except with respect to the Seller letter to FDA referenced in Section 12.1.1) or other Governmental Entities as required by Law related to the ANDAs, including payment of any fees for periods after the Closing Date owed under Generic Drug User Fee Amendments of 2012 and preparing and filing all required reports (including adverse drug experience reports) with the appropriate Governmental Entity. Notwithstanding anything to the contrary in this Agreement, from and after the Closing Date, Seller shall continue to be responsible for compliance with Laws with respect to the sale and distribution of Products pursuant to Section 2.5 hereof.
​
12.3           Supplementing ANDAs. From and after the Closing Date, Buyer shall (a) have sole responsibility for supplementing the ANDAs to include facilities designated by Buyer and (b) assume all responsibility for maintenance of the ANDAs. Promptly following the end of the Seller Distribution Term, Buyer shall delete Seller’s facilities referenced in the ANDAs. All decisions regarding the conduct of regulatory activities with respect to the ANDAs on or after the Closing Date shall be made by Buyer in its sole and absolute discretion, and all such regulatory activities shall be at its sole cost. Notwithstanding anything herein to the contrary, Buyer and its Affiliates shall not, directly or indirectly, take (or omit to take) any action that would or could reasonably be expected to have a material adverse effect on Seller’s ability to exercise its rights or comply with its on-going obligations under this Agreement or any Ancillary Agreement.
​
12.4           Seller’s NDC Numbers. Buyer and its Affiliates shall not sell any Products under Seller’s or its Affiliates’ names or NDC numbers.
​
​

15

​

​
12.5           Response to Medical Inquiries and Product Complaints. The terms of the Quality Agreement shall govern the Parties’ responsibilities for responding to any medical inquiries or complaints about any Product (including Product bearing Seller’s NDC numbers), which arose prior to, or arise on or after the Closing Date.
​
12.6           Responsibility for Recalls, Withdrawals, and Field Corrections. The terms of the Quality Agreement shall govern the Parties’ responsibilities for recalls, withdrawals and field corrections.
​
13.               TRANSFER TAXES. All transfer, sales, value added, stamp duty and similar Taxes payable in connection with the transaction contemplated hereby will be borne [***] Buyer and Seller.
​
14.               NON-COMPETE.
​
14.1           Non-Compete. [***].
​
14.2           Equitable Relief. The Seller acknowledges that a breach or threatened breach of this Section 14 would give rise to irreparable harm to Buyer, for which monetary damages would not be an adequate remedy, and hereby agrees that in the event of a breach or a threatened breach by Seller of any such obligations, Buyer shall, in addition to any and all other rights and remedies that may be available to it in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance and any other relief that may be available from a court of competent jurisdiction (without any requirement to post bond). With respect to Seller, the Restricted Period will be extended by the duration of any breach by that Seller of his, her or its respective covenants in this Section 14.
​
14.3           Reasonable Restrictions. Seller acknowledges that the restrictions contained in this Section 14 are reasonable and necessary to protect the legitimate interests of Buyer and constitute a material inducement to Buyer to enter into this Agreement and consummate the transactions contemplated by this Agreement. In the event that any covenant contained in this Section 14 should ever be adjudicated to exceed the time, geographic, product or service or other limitations permitted by Law in any jurisdiction, then any court is expressly empowered to reform such covenant, and such covenant shall be deemed reformed, in such jurisdiction to the maximum time, geographic, product or service or other limitations permitted by applicable Law. The covenants contained in this Section 14 and each provision of this Section 14 are severable and distinct covenants and provisions. The invalidity or unenforceability of any such covenant or provision as written shall not invalidate or render unenforceable the remaining covenants or provisions, and any such invalidity or unenforceability in any jurisdiction shall not invalidate or render unenforceable such covenant or provision in any other jurisdiction.
​
​
15.               POST-CLOSING NEGOTATIONS.
​
15.1           [***]. Following the Closing Date, the Parties shall use their commercially reasonable efforts to negotiate a commercially reasonable [***] agreement between Buyer and Seller (or Seller’s Affiliates) [***].
​
15.2           [***]. Following the Closing date, upon the request of Buyer, Seller will discuss with Buyer in good faith to evaluate the feasibility of [***]. If such activities are deemed feasible by the Parties, Buyer and Seller will use their commercially reasonable efforts to negotiate a commercially reasonable [***] contract.
​
16.               FURTHER ASSURANCES; TECHNICAL TRANSFER ACTIVITIES.
​
​

16

​

​
16.1           Delivery of Purchased Assets. Promptly following the Closing, but in no event later than thirty (30) Business Days after the Closing, Seller shall furnish the Buyer with copies of, and provide Buyer with ongoing access to, all Purchased Assets that are in tangible form and were not required to be delivered as of the Closing, except that: (a) Sample Products and all Raw Materials shall be transferred in accordance with Sections 16.1.1(a) and 16.1.1(b), respectively, of this Agreement and (b) Technical Transfer Documentation shall be transferred in accordance with Section 16.1.2 of this Agreement. The Seller agrees to work diligently and in good faith to complete the transfers set forth in this Section 16.1 from Seller to Buyer. Seller shall deliver the Data Room Materials to Buyer in electronic format prior to terminating Buyer’s access to the electronic data room.
​
16.1.1            Transfer of Sample Products and Raw Materials. (a) Within thirty (30) Business Days after the Closing Date, Seller and/or its Affiliate shall transfer the Sample Products to Buyer’s and/or its Affiliate’s common carrier according to Ex Works (EXW) (Incoterms 2010) from the facility at which such Sample Products are located as of the date of such transfer; such common carrier to be specified by Buyer in writing at least seven (7) Business Days prior to the date that such transfer will occur; and (b) within thirty (30) Business Days after the Closing Date, Seller and/or its Affiliate shall transfer the Raw Materials to Buyer’s and/or its Affiliate’s common carrier according to Ex Works (EXW) (Incoterms 2010) from the facility at which such Raw Materials are located as of the date of such transfer; such common carrier to be specified by Buyer in writing at least seven (7) Business Days prior to the date that such transfer will occur (Buyer acknowledges that Raw Materials are located a different facilities).
​
16.1.2            Transfer of Certain Portions of the Technical Transfer Documentation. Seller and/or its Affiliate shall use commercially reasonable efforts to transfer the Technical Transfer Documentation that is readily available and within Seller’s and/or its Affiliate’s possession as of the Closing Date, in electronic format (to the extent available in such format), to Buyer within thirty (30) Business Days after the Closing Date.
​
16.2           Further Assurances. Following the Closing, each of the Parties shall, and shall cause their respective Affiliates to, execute and deliver such additional documents, instruments, conveyances and assurances and take such further actions as may be reasonably required to carry out the provisions hereof and give effect to the transactions contemplated by this Agreement and the Ancillary Agreements.
​
​
17.               MISCELLANEOUS.
​
17.1           Arbitration. Any disputes arising out of or in connection with this Agreement shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by three arbitrators appointed in accordance with the rules. The legal place of arbitration shall be New York, NY, USA. The language of the arbitration shall be English.
​
17.2           Governing Law; English Language. This Agreement shall be governed, interpreted and construed in accordance with the substantive laws of the State of Delaware, U.S.A., without regard to its conflict of laws principles. To the extent that it may otherwise by applicable, the Parties hereby expressly agree to unconditionally waive and exclude from the operation of this Agreement the United Nations Convention on Contracts for the International Sale of Goods, concluded at Vienna, on 11 April 1980, as amended and as may be amended further from time to time. This Agreement has been negotiated and drafted by the Parties in the English language. Any translation into any other language shall not be an official version thereof. In the event any translation of this Agreement is prepared for convenience or for any other purpose, the provisions of the English version shall prevail.
​
​

17

​

​
17.3           Notices. All notices and other communications required or permitted to be given or made pursuant to this Agreement shall be in writing signed by the sender and shall be deemed duly given (a) on the date delivered, if personally delivered, (b) on the date sent by telecopier with automatic confirmation by the transmitting machine showing the proper number of pages were transmitted without error, (c) on the Business Day after being sent by Federal Express or another recognized overnight mail service which utilizes a written form of receipt for next day or next Business Day delivery or (d) three (3) Business Days after mailing, if mailed by U.S. postage-prepaid certified or registered mail, return receipt requested, in each case addressed to the applicable Party at the address set forth below; provided that a Party may change its address for receiving notice by the proper giving of notice hereunder:
​
if to Seller, to:
​
Sandoz Inc.
100 College Road West
Princeton, New Jersey 08540
Attention: President
​
With a copy (which shall not constitute notice) to:
​
Sandoz Inc.
100 College Road West
Princeton, New Jersey 08540
Attention: General Counsel
​
if to Buyer, to:
​
CASI Pharmaceuticals, Inc.
9620 Medical Center Drive #300
Rockville, Maryland 20850
Attention: Chief Executive Officer
​
With a copy (which shall not constitute notice) to:
​
CASI Pharmaceuticals, Inc.
9620 Medical Center Drive #300
Rockville, Maryland 20850
Attention: General Counsel
​
17.4           Relationship of Parties. The status of the Parties under this Agreement shall be that of independent contractors, without the authority to act on behalf of or bind each other. Nothing in this Agreement shall be construed as establishing a partnership or joint venture relationship between the Parties hereto.
​
17.5           Entire Agreement; Amendment. This Agreement and the Ancillary Agreements (and all Exhibits and Schedules attached hereto and thereto) supersede all prior discussions and agreements among the Parties with respect to the subject matter hereof and contains the sole and entire agreement among the Parties hereto with respect to the subject matter hereof. This Agreement may not be amended or modified except in writing executed by the duly authorized representatives of the Parties.
​
​

18

​

​
17.6           No Third-Party Beneficiaries. Except as specifically provided herein, this Agreement is not intended to confer upon any Person other than the Parties hereto any rights or remedies hereunder.
​
17.7           Severability. Should any part or provision of this Agreement be held unenforceable or in conflict with Law, the invalid or unenforceable part or provision shall, provided that it does not affect the essence of this Agreement, be replaced with a revision which accomplishes, to the greatest extent possible, the original commercial purpose of such part or provision in a valid and enforceable manner, and the balance of this Agreement shall remain in full force and effect and binding upon the Parties hereto.
​
17.8           Assignment. The terms and provisions hereof shall inure to the benefit of, and be binding upon the Parties and their respective successors and permitted assigns. No Party shall assign, encumber or otherwise transfer this Agreement or any part of it to any Third Party, without the prior written consent of the other Party which consent will not be unreasonably withheld; provided, however, that notwithstanding the foregoing, no such consent shall be required in the event of any assignment or transfer of this Agreement (a) [***], or (b) by either Party, to any successor in interest to such Party’s business, whether by merger, sale of assets or otherwise; in the event of which a Party shall only be required to give written notice of such assignment or transfer to the other Party but will not be required to obtain the consent of the other Party. In the case of any sale, assignment, divestiture or other transfer, the assigning Party shall remain liable for the full and timely performance of the transferee
​
17.9           Waiver. No waiver of a breach or default hereunder shall be considered valid unless in writing and signed by the Party giving such waiver, and no such waiver shall be deemed a waiver of any subsequent breach or default of the same or similar nature.
​
17.10        Survival. Any provision which by its terms is intended to survive the termination or expiration of this Agreement will survive the termination or expiration of this Agreement and remain in full force and effect thereafter.
​
17.11        Interpretation. For purposes of this Agreement, (a) the words “include,” “includes” and “including” shall be deemed to be followed by the words “without limitation,” (b) the word “or” is not exclusive and (c) the words “herein,” “hereof,” “hereby,” “hereto” and “hereunder” refer to this Agreement as a whole. Unless the context otherwise requires, references herein: (i) to clauses or annexes mean the clauses of, and annexes to, this Agreement, (ii) to an agreement, instrument or other document means such agreement, instrument or other document as amended, supplemented and modified from time to time to the extent permitted by the provisions thereof, and (iii) to a statute means such statute as amended from time to time and includes any successor legislation thereto and any regulations promulgated thereunder. This Agreement shall be construed without regard to any presumption or rule requiring construction or interpretation against the Party drafting an instrument or causing any instrument to be drafted. The annexes referred to herein shall be construed with, and be an integral part of, this Agreement to the same extent as if they were set forth herein.
​
​
17.12        Counterparts; PDF. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original but all of which, taken together, shall constitute one and the same instrument. PDF and facsimile signatures shall constitute original signatures. The Parties agree that the electronic signatures appearing on this Agreement are the same as handwritten signatures for the purposes of validity, enforceability and admissibility pursuant to the Electronic Signatures in Global and National Commerce (ESIGN) Act of 2000, and Uniform Electronic Transactions Act (UETA) model law, or similar applicable laws.
​
​

19

​

​
17.13        WAIVER OF CONSEQUENTIAL DAMAGES. IN NO EVENT SHALL EITHER PARTY OR ITS AFFILIATES HAVE ANY LIABILITY TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS) OF THE OTHER ARISING OUT OF THE PERFORMANCE OR FAILURE TO PERFORM ANY OBLIGATIONS SET FORTH HEREIN, IRRESPECTIVE OF WHETHER ATTRIBUTABLE TO BREACH OF CONTRACT, BREACH OF WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, OTHER THAN WITH RESPECT TO INDEMNIFICATION CLAIMS PURSUANT TO SECTION 7 TO THE EXTENT PAYABLE TO THIRD PARTIES.
​
[Signature Page Follows]
​
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the date first above written.
​
	

	

	

	CASI PHARMACEUTICALS, INC.

	
	 
	 
	 

	By:
	/s/ Ken K. Ren
	 

	 
	Dr. Ken K. Ren, Chief Executive Officer
	 

	 
	 
	 

	 
	 
	 

	SANDOZ INC.

	 
	 
	 

	 
	 
	 

	By:
	/s/ Peter Goldschmidt
	 

	 
	 
	 

	Name:
	Peter Goldschmidt
	 

	 
	 
	 

	Title:
	President, Sandoz US and Head of North America
	 

​
[SIGNATURE PAGE TO ASSET PURCHASE AGREEMENT]
​

20

​

EXHIBITS
​
	

	

	

	Exhibit A
	    
	Bill of Sale

	 
	 
	 

	Exhibit B
	 
	Pharmacovigilance Agreement

	 
	 
	 

	Exhibit C
	 
	Quality Agreement

	​
	​
	​

	Exhibit D
	 
	Form of Assignment and Assumption Agreement for Intellectual Property Agreement(s)

	 
	 
	 

	Exhibit E
	 
	Forms of Seller and Buyer FDA Letters

	​
	​
	​

	Exhibit F
	​
	Transition Agreement

	 
	​
	 

	Exhibit G
	 
	Technical Transfer Documentation

​
​

21

​

Exhibit A
​
Bill of Sale
​
[See attached]
​
Bill of Sale
​
THIS BILL OF SALE (the “Bill of Sale”), dated as of January 26, 2018, is made and delivered by Sandoz Inc., a corporation organized under the laws of the State of Colorado (“Seller”), to CASI Pharmaceuticals, Inc., a Delaware corporation, with offices at 9620 Medical Center Drive, #300, Rockville, Maryland (“Buyer”), (each a “Party”, collectively the “Parties”).
​
WHEREAS, pursuant to that certain Asset Purchase Agreement, dated as of January 26, 2018, by and between Seller and Buyer (the “Asset Purchase Agreement”), Seller has agreed to transfer, sell, convey, assign and deliver to Buyer, and Buyer has agreed to purchase, accept and assume as of the date hereof, all right, title and interest of the Purchased Assets (as defined in the Asset Purchase Agreement); and
​
WHEREAS, the Parties desire to deliver to each other such instruments as are required in order to effectuate and evidence the sale by Seller and purchase by Buyer of the Purchased Assets.
​
NOW, THEREFORE, in consideration of the premises and in accordance with the provisions of the Asset Purchase Agreement, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Seller and Buyer hereby each agree as follows:
​
		1.
	The terms of the Asset Purchase Agreement are incorporated herein by reference and capitalized terms used but not defined in this Bill of Sale shall have the meaning ascribed thereto in the Asset Purchase Agreement.

		2.
	Seller hereby irrevocably and unconditionally transfers, sells, conveys, assigns, and delivers to Buyer, and Buyer hereby irrevocably and unconditionally purchases, accepts and assumes, all of Seller's right, title and interest in and to all of the Purchased Assets, free and clear of any Encumbrances.

		3.
	The Buyer hereby assumes and agrees to pay, perform, and discharge all liabilities and obligations constituting the Assumed Liabilities.

		4.
	All of the terms and provisions of this Bill of Sale shall be binding upon Seller and its successors and permitted assigns, and shall be binding upon Buyer and its successors and permitted assigns.

​

22

​

		5.
	This Bill of Sale and any all matters arising directly or indirectly herefrom shall be governed by and construed and enforced in accordance with the laws of the State of Delaware applicable to agreements made and to be performed entirely in such State without regard to the conflict of laws principles thereof.

		6.
	It is acknowledged and agreed that this Bill of Sale is intended to document the sale and assignment of the Purchased Assets to Buyer.

		7.
	This Bill of Sale may be executed by PDF and in one or more counterparts, each of which shall be deemed an original and all of which together shall constitute a single instrument. The Parties agree that the electronic signatures appearing on this Bill of Sale are the same as handwritten signatures for the purposes of validity, enforceability and admissibility pursuant to the Electronic Signatures in Global and National Commerce (ESIGN) Act of 2000, and Uniform Electronic Transactions Act (UETA) model law, or similar Laws.

​
[Signature Page Follows]
​
IN WITNESS WHEREOF, the Parties hereto have executed this Bill of Sale as of the date first above written.
​
	

	

	

	CASI PHARMACEUTICALS, INC.

	By:
	 
	 

	 
	 
	 

	Name:
	 
	 

	 
	 
	 

	Title:
	 
	 

	 
	 
	 

	 
	 
	 

	SANDOZ INC.

	 
	 
	 

	 
	 
	 

	By:
	 
	 

	 
	 
	 

	Name:
	 
	 

	 
	 
	 

	Title:
	 
	 

​
​

23

​

Exhibit B
​
Pharmacovigilance Agreement
​
[See attached]
​
Executive Version
​
Pharmacovigilance Agreement
​
between
​
Sandoz Inc.
​
100 College Road West
Princeton, New Jersey 08540
(“Sandoz”)
​
And
​
CASI Pharmaceuticals Inc.
9620 Medical Center Drive, Suite 300
Rockville, MD 20850 (“CASI”)
​

	​

	​

	CASI / Sandoz Pharmacovigilance Agreement​
	Page 1 of 10

​

​

Table of Contents
​
	

	

	1. PURPOSE
	3

	2 SCOPE
	3

	3 EFFECTIVE DATE AND REVIEW
	3

	4 RESPONSIBILITIES
	4

	5 DEFINITIONS
	4

	6 TRAINING
	4

	7 URGENT SAFETY ACTIONS
	4

	8 INTAKE AND EXCHANGE OF AE AND SPECIAL SITUATION INFORMATION
	4

	9 SAFETY REGULATORY REPORTS
	5

	10 AE REPORT PROCESSING AND FOLLOW-UP
	5

	11 LITERATURE REVIEW
	5

	12 SAFETY ISSUES/SIGNALS
	5

	13 RECONCILIATION AND CONFIRMATION OF RECEIPT
	5

	14 REGULATORY AUTHORITY INTERACTIONS
	6

​
​

	​

	​

	CASI / Sandoz Pharmacovigilance Agreement​
	Page 2 of 10

​

​

	

	

	15 RISK EVALUATION AND MITIGATION STRATEGY (REMS)
	6

	16 SUMMARY OF RESPONSIBILITIES
	6

	17 COMPLIANCE WITH PHARMACOVIGILANCE AGREEMENT AUDITS
	6

	18 SIGNATURES/DATES
	8

	APPENDIX I - List of Contacts
	9

	APPENDIX II – Product(s):
	10

​
​
1. PURPOSE
​
Sandoz and CASI are parties to that certain Asset Purchase Agreement (as such agreement may be amended from time to time, the “APA”), executed on even date with this Pharmacovigilance Agreement (this “PVA”).
​
The purpose of this PVA is to describe the procedures and define the responsibilities that Sandoz and CASI will employ to ensure that AE (as defined in Section 5 below) notification and reporting requirements for the product(s) listed in Appendix II (the “Products”) meet applicable regulatory authority regulations set forth in 21 C.F.R. § 314.80 and guidelines. CASI, as marketing authorization holder in the USA, has certain pharmacovigilance (“PV”) obligations in order to meet applicable regulatory rules and guidelines. Sandoz and CASI may each be referred to herein as a “Party” and collectively as the “Parties”.
​
Except as otherwise set forth herein, CASI will take over all regulatory responsibilities for AE reporting with respect to the Products as of the Effective Date.
​
Except as otherwise set forth herein, Sandoz will no longer have any regulatory responsibilities for AE reporting with respect to the Products as of the Effective Date.
​
For a list of Product(s) see Appendix II. Both Parties must agree in writing on any updates to the list of Products.
​
The capitalized terms used in this PVA shall have the meanings as defined herein, and if not defined herein, as defined in the APA, as applicable.
​
2. SCOPE
​
This PVA applies to AE reporting requirements for the Products as per 21 C.F.R. § 314.80. The obligations in this PVA are an extension of and supplement to any AE reporting requirements for the Products set forth in the APA. In the event of a conflict between the terms of PVA and the APA, the terms of the PVA shall control in regards to AEs.
​
3. EFFECTIVE DATE AND REVIEW
​
This PVA shall become effective on the Closing Date (the “Effective Date”) and will automatically terminate upon the expiration of the Seller Distribution Term. No provision of this PVA may be amended or modified other than by a written document signed by an authorized representative of each Party.
​
Sandoz shall commit to forward AEs after execution of this PVA as per local regulations, i.e. forwarding of AEs when received by error on the tradename of another company who is marketing authorization holder for the Products.
​
If applicable regulatory requirements change, there is disagreement regarding the interpretation of any aspect of this PVA, and/or either Party requests a review of this PVA due to issues or conflicts involving legal or regulatory requirements, the Parties agree to review, and, if appropriate, amend and/or revise the terms of this PVA.
​

	​

	​

	CASI / Sandoz Pharmacovigilance Agreement​
	Page 3 of 10

​

​

​
Renegotiation/review shall be considered complete when the Parties execute a written amendment or addendum to this PVA.
​
4. RESPONSIBILITIES
​
The Parties agree to implement the necessary training, procedures and systems/processes for the timely and direct reporting of any AE or Special Situation (as defined in Section 5 below) reports made known to them, as set forth in this PVA.
​
The Parties also agree that persons performing the tasks described in this PVA are qualified to perform those tasks.
​
The Parties agree that data privacy must be maintained at all times in relation to the activities defined in this PVA.
​
5. DEFINITIONS
​
Adverse Event (“AE”) is any untoward medical occurrence in a patient or clinical-trial subject administered a medicinal Product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal Product or device, whether or not considered related to such medicinal Product or device.
​
“Special Situations”: In addition, for the purposes of this PVA, Special Situations, such as reports of use during pregnancy (with or without outcome), use during lactation, dispensing errors, maladministration, accidental or occupational exposure, pediatric exposure, unexpected benefit, overdose, lack of efficacy, drug-drug interaction, withdrawal syndrome, drug dependence, misuse, abuse or addiction, transmission of infectious disease, disease progression or aggravation, off-label use, treatment noncompliance, withdrawal periods, environmental issues and use of counterfeit product shall be reported by Sandoz to CASI following the requirements of AE reporting even if no AE has occurred.
​
“Urgent Safety Action”: This refers to a Product recall, withdrawal, restriction, and/or field correction, including recalls, withdrawals, restrictions, and/or field corrections of such Product required by any Governmental Entity or voluntary recalls, withdrawals, restrictions, and/or field corrections of such Product.
​
6. TRAINING
​
Each Party shall ensure that all each Party’s personnel involved with carrying out the terms of the PVA are trained appropriately. Training documentation will be maintained by each Party.
​
7. URGENT SAFETY ACTIONS
​
Urgent Safety Actions will be handled in accordance with the terms set forth in the APA and the Quality Agreement.
​
8. INTAKE AND EXCHANGE OF AE AND SPECIAL SITUATION INFORMATION
​
In the event that Sandoz learns of any AEs, Product complaints, or Special Situations for the Products, Sandoz will record all available AE, Product complaint, or Special Situation information on an intake form and e-mail the completed form to CASI via e-mail with read receipt as soon as possible but no later than five (5) calendar days of
​

	​

	​

	CASI / Sandoz Pharmacovigilance Agreement​
	Page 4 of 10

​

​

receipt. Sandoz will provide to CASI all information provided to Sandoz relating to the AE, Product complaint, or Special Situation but minimally, the following information will be provided:
​
		●	Date that Sandoz was notified of the AE, Product complaint, or Special Situation;

		●	Name and contact details of the reporter;

		●	Name of the Product;

		●	Nature of the AE, Product complaint, or Special Situation; and

		●	Patient details (if available).

​
The contacts for each Party are identified in Appendix I. Either Party may change its contact persons and/or its primary liaison upon immediate notification to the other Party in writing.
​
Sandoz Patient Safety will send a PDF copy of the original AE source document received by Sandoz Patient Safety, and it will be send to CASI via e-mail at the e-mail address listed in Appendix I. Both Sandoz and CASI will agree to maintain records of all safety information that has been exchanged for the purpose of future audits and/or inspections by FDA and/or regulatory authority, and in accordance with compliance with this PVA. All exchanged safety information records will be maintained for a period of no less than 10 years.
​
9. SAFETY REGULATORY REPORTS
​
CASI will hold and maintain the global safety database for all AEs occurring with Products reported to either Party. CASI is responsible for the preparation and submission of all safety reports, and including all ICSRs (15-day reports) as well as all aggregate reports (PADERs) in accordance with regulatory requirements.
​
10. AE REPORT PROCESSING AND FOLLOW-UP
​
CASI is responsible for processing AE reports including performing database entry/assessment, completing medical review, and performing any follow-up, as required.
​
11. LITERATURE REVIEW
​
CASI is responsible for performing review of the worldwide scientific literature for AE information related to Products in accordance with its procedures.
​
12. SAFETY ISSUES/SIGNALS
​
CASI is responsible for identifying safety issues or signals relating to Products and communicating safety issues to appropriate regulatory authorities.
​
13. RECONCILIATION AND CONFIRMATION OF RECEIPT
​
CASI will respond back to Sandoz for each AE report communicated to CASI, preferably within forty-eight (48) hours, but no later than two (2) Business Days after receipt by CASI. If Sandoz does not receive a response back within the above stated timeframe, Sandoz will continue to communicate the AE report until confirmation is received.
​
Sandoz shall provide cumulative reconciliation information during the Term of this PVA in accordance with Section 3 hereof. Sandoz and CASI will effectively perform a monthly reconciliation to ensure that all forwarded reports of all safety information have been successfully exchanged between both companies.
​

	​

	​

	CASI / Sandoz Pharmacovigilance Agreement​
	Page 5 of 10

​

​

14. REGULATORY AUTHORITY INTERACTIONS
​
CASI is responsible for completing and reporting of AE reports for Products and for submission to regulatory/competent authorities. This includes individual case 15-Day Alert Reports and Periodic Safety Reports or Periodic Safety Update Reports, if applicable.
​
Communications with FDA relating to PV issues for the Products will be the responsibility of CASI.
​
15. RISK EVALUATION AND MITIGATION STRATEGY (REMS)
​
If a local REMS or other risk management activity is required for Products by a regulatory authority, CASI shall be responsible for the authorship, submission and administration of the program.
​
16. SUMMARY OF RESPONSIBILITIES
​
Responsibilities are summarized below.
​
	

	

	

	Activity
	CASI
	Sandoz

	Receipt of AE Reports
	[***]
	[***]

	Email Transfer of AEs, Product complaints, and Special Situations
	[***]
	[***]

	AE Processing (Data entry, evaluation, assessment, follow-up)
	[***]
	[***]

	Safety Report Preparation and Submission
	[***]
	[***]

	Signal Identification
	[***]
	[***]

	Literature Review
	[***]
	[***]

	Regulatory Reporting Related to AEs
	[***]
	[***]

	Interactions with Regulatory Authorities Related to AEs
	[***]
	[***]

	Immediate Confirmation of Receipt
	[***]
	[***]

	Reconciliation Listing
	[***]
	[***]

	Perform Reconciliation Against Database
	[***]
	[***]

	Risk Management Plans
	[***]
	[***]

​
17. Compliance with Pharmcovigilance Agreement Audits
​
The Parties shall communicate urgent or critical issues affecting the other Party’s pharmacovigilance system in relation to meeting the obligations set forth in this PVA - within [***] Business Days of discovery or receipt of documented findings cited during a regulatory authority inspection. Once corrective actions are determined, the inspected Party will provide a summary of the relevant inspection findings with associated corrective actions where the other Party is impacted.
​
​

	​

	​

	CASI / Sandoz Pharmacovigilance Agreement​
	Page 6 of 10

​

​

​
Either Party may audit the other Party’s pharmacovigilance systems/operations or contracted pharmacovigilance activities, giving [***] days’ notice, to ensure that the elements set forth in this PVA are being fulfilled for the Product(s). As soon as the decision to audit is taken, all such audits will be notified by respective companies.
​
Audits must be reasonable in scope and in relationship to the Product and must take place during normal business hours. Parties will correct audit observations in a timely manner and communicate those actions to the other Party.
​
In the case of a serious suspected breach of compliance with this PVA, a directed audit will be performed by either party or an independent third party with notification only and a minimum of [***] days. The possibility of a directed audit for serious breach is therefore agreed upon by way of execution of this agreement.
​
Parties shall allow foreign and local health authorities to inspect their pharmacovigilance operations as it is necessary for either Party to maintain registration in the countries where the Product is marketed. The Parties shall allow foreign and local health authorities to inspect their pharmacovigilance operations as necessary for with Party to maintain a marketing authorization. The Parties shall inform each other of any local Product-specific pharmacovigilance inspections at the time they receive notification of the inspection.
​
​
18. SIGNATURES/DATES
​
This PVA has been agreed upon by the following Parties.
​
​
​
	

	

	

	Sandoz Inc.
	    
	CASI Pharmaceuticals, Inc.

	 
	 
	 

	 
	 
	 

	 
	 
	  

	Signature, Date
	 
	Signature, Date

	 
	 
	 

	[***]
	 
	[***]

	[***]
	 
	[***]

​
[***] This portion has been redacted pursuant to a confidential treatment request.
​
APPENDIX I - List of Contacts
​
	Sandoz Inc.
	CASI

​
​

	​

	​

	CASI / Sandoz Pharmacovigilance Agreement​
	Page 7 of 10

​

​

	

	​
***]
​
​

	 
	AEs; Product complaints, Product and Special Situations Requests:
​
[***]
 

	Primary Contact and AE specific Questions:
​
[***]
	Primary Contacts:
​
[***]
 

	Secondary Contact and AE specific Questions:
​
[***]
	Secondary Contact and AE specific Questions:
​
[***]
 

​
APPENDIX II – Product(s):
​
	

	BENAZEPRIL 10MG 100FCT BO V1 US

	 BENAZEPRIL 10MG 500FCT BO US

	 BENAZEPRIL 20MG 100FCT BO V1 US

	 BENAZEPRIL 20MG 500FCT BO US

	 BENAZEPRIL 5MG 100FCT BO V1 US

	 BENAZEPRIL 5MG 500FCT BO US

	 BISOP FUM 10MG 100FCT BO US

	 BISOP FUM 10MG 30FCT BO US

	 BISOP FUM 5MG 100FCT BO US

	 BISOP FUM 5MG 30FCT BO US

	 CEFPROZIL 250MG 100FCT BO US

	 CEFPROZIL 500MG 100FCT BO US

	 CEFPROZIL 500MG 50FCT BO US

	 CILOSTAZOL 100MG 500TAB BO US

	 CILOSTAZOL 100MG 60TAB BO US

	 CILOSTAZOL 50MG 60TAB BO US

	 DICLOFENAC POT 50MG 100FCT BO US

	 DICLOFENAC SOD 25MG 100GRT BO US

	 DICLOFENAC SOD 50MG 60GRT BO US

	 DICLOFENAC SOD 75MG 1000GRT BO US

	 DICLOFENAC SOD 75MG 100GRT BO US

	 DICLOFENAC SOD 75MG 500GRT BO US

	 DICLOFENAC SOD 75MG 60GRT BO US

	 ECONAZOLE NITRATE 1% 15G CRM US

	 ECONAZOLE NITRATE 1% 30G CRM US

	 ECONAZOLE NITRATE 1% 85G CRM US

	 HEPARIN SOD 5000IU/1ML 10LIVI US

​
​

	​

	​

	CASI / Sandoz Pharmacovigilance Agreement​
	Page 8 of 10

​

​

​
	

	 LISINOPRIL 10MG 1000TAB BO V5 US

	 LISINOPRIL 10MG 100TAB BO V4 US

	 LISINOPRIL 2.5MG 1000TAB BO V2 US

	 LISINOPRIL 2.5MG 100TAB BO V4 US

	 LISINOPRIL 20MG 1000TAB BO V5 US

	 LISINOPRIL 20MG 100TAB BO V4 US

	 LISINOPRIL 30MG 100TAB BO V3 US

	 LISINOPRIL 40MG 1000TAB BO V5 US

	 LISINOPRIL 40MG 100TAB BO V3 US

	 LISINOPRIL 5MG 1000TAB BO V2 US

	 LISINOPRIL 5MG 1000TAB BO V5 US

	 LISINOPRIL 5MG 100TAB BO V1 US

	 LISINOPRIL 5MG 100TAB BO V3 US

	 LISINOPRIL BPP 10MG 1000TAB BO V1 US

	 LISINOPRIL BPP 10MG 100TAB BO V1 US

	 LISINOPRIL BPP 20MG 1000TAB BO V1 US

	 LISINOPRIL BPP 20MG 100TAB BO V1 US

	 LISINOPRIL BPP 30MG 100TAB BO V1 US

	 LISINOPRIL BPP 40MG 1000TAB BO V1 US

	 LISINOPRIL BPP 40MG 100TAB BO V1 US

	 LISINOPRIL BPP 5MG 1000TAB BO US

	 LISINOPRIL BPP 5MG 100TAB BO US

	 METHIMAZOLE 10MG 1000TAB BO US

	 METHIMAZOLE 10MG 100TAB BO US

	 METHIMAZOLE 5MG 1000TAB BO US

	 METHIMAZOLE 5MG 100TAB BO US

	 MIDODRINE 10MG 100TAB BO US

	 MIDODRINE 2.5MG 100TAB BO US

	 MIDODRINE 5MG 100TAB BO US

	 MIDODRINE 5MG 500TAB BO US

	 NABUMETONE 500MG 100FCT BO US

	 NABUMETONE 500MG 500FCT BO US

	 NABUMETONE 750MG 100FCT BO US

	 NABUMETONE 750MG 500FCT BO US

	 NARATRIPTAN 2.5MG 9FCT UD US

	 ONDANSETRON HCL 4MG 30FCT BO US

	 ONDANSETRON HCL 4MG 3FCT UD V1 US

	 ONDANSETRON HCL 8MG 30FCT BO V1 US

	 REPAGLINIDE 0.5MG 100TAB BO US

	 REPAGLINIDE 1MG 100TAB BO US

	 REPAGLINIDE 2MG 100TAB BO US

	 RIBAVIRIN 200MG 56HGC BO US

	 SPIRONOLACTONE 25MG 1000FCT BO US

​
​

	​

	​

	CASI / Sandoz Pharmacovigilance Agreement​
	Page 9 of 10

​

​

​
	

	 SPIRONOLACTONE 25MG 100FCT BO US

	 SPIRONOLACTONE 25MG 500FCT BO US

	 TIZANIDINE 2MG 1000TAB BO US

	 TIZANIDINE 2MG 150TAB BO US

	 TIZANIDINE 4MG 1000TAB BO US

	 TIZANIDINE 4MG 150TAB BO US

	 TIZANIDINE 4MG 300TAB BO US

	 TRIAM/HCT 50+25MG 100HGC BO US

​
​
​

	​

	​

	CASI / Sandoz Pharmacovigilance Agreement​
	Page 10 of 10

​

​

Exhibit C
​
Quality Agreement
​
[See attached]
​
Exhibit C to the Asset Purchase Agreement - Quality Agreement
​
This quality agreement (“Quality Agreement”) addresses key quality attributes not covered in that certain Asset Purchase Agreement dated January 26, 2018, by and between the Parties dated (the “APA”). This Quality Agreement shall become effective as of the Closing Date. Capitalized terms used but not otherwise defined herein shall have the meanings ascribed to such terms in the APA. To the extent there is any conflict between the terms of this Quality Agreement and the terms of the APA, the terms of the Quality Agreement shall prevail with regard to quality issues. For all other matters, the terms of the APA shall prevail.
​
		1.0
	Introduction:

​
In accordance with the terms and conditions of the APA, CASI Pharmaceuticals, Inc. (“BUYER”) and Sandoz Inc. (“SANDOZ”) desire to allocate between themselves certain regulatory responsibilities for the Distribution Products (defined below) set forth on Exhibit A attached hereto during the Seller Distribution Term. SANDOZ (or its Affiliate) is the manufacturer and packager of the Distribution Products listed on Exhibit A of this Quality Agreement. Notwithstanding the foregoing, the regulatory requirements for the Distribution Products are maintained under the applicable regulatory filings for the Products purchased by BUYER under the terms of the APA. “Distribution Products” means the Products set forth on Exhibit A attached hereto that Seller will distribute after the Closing Date.
​
		2.0
	Current Good Manufacturing Practices (cGMP) and Applicable Law:

​
		2.1
	BUYER and SANDOZ agree that SANDOZ (or its Affiliate) shall manufacture all Distribution Products under a quality system that ensures the Distribution Products (i) are compliant with Law, including current good manufacturing practice (“cGMP”), and (ii) meet U.S. Food and Drug Administration (FDA)-approved product specifications.

​
		3.0
	GDUFA:

​
​

	​

	​

	​

	​
	1
	​

​

​

		3.1
	BUYER shall follow FDA Guidance on Self-Identification of Generic Drug Facilities, Sites, and Organizations and related fees as outlined in the Generic Drug User Fee Amendments (“GDUFA”) (if applicable).

​
		4.0
	Change Management and Approval:

​
4.1SANDOZ and BUYER shall utilize a change control procedure in accordance with their respective standard operating procedure(s) (“SOP”) to ensure appropriate review of all manufacturing changes.
4.2SANDOZ shall inform BUYER regarding major changes to a Distribution Product or process.
		4.3
	Changes in specifications of material resulting from the update of compendia and pharmacopoeia will be made by SANDOZ without BUYER’s prior approval, but SANDOZ shall notify BUYER regarding the same in writing within [***] Business Days of such change(s).

​
		5.0
	Product Quality Review (PQR)/Annual Product Review (APR):

​
		5.1
	BUYER may request information in support of the PQR/APR. During the Term of this Quality Agreement, SANDOZ shall provide documentation to support the BUYER’s PQR/APR on an annual basis in accordance with cGMP requirements.

​
Exhibit C to the Asset Purchase Agreement - Quality Agreement
​
​
		6.0
	Batch Manufacturing and Packaging Records:

​
6.1SANDOZ shall ensure that manufacturing and packaging of the Distribution Products is carried out in compliance with applicable Laws and according to approved manufacturing procedures and packaging instructions.
6.2SANDOZ shall compile and archive clear structured batch documentation for each batch of the Distribution Products. The manufacturing batch records as well as testing documentation kept by SANDOZ shall comply with cGMP requirements.
		6.3
	SANDOZ shall ensure that, upon special requests from BUYER for applicable Regulatory Authorities, the following documents will be provided as copies within [***] Business Days to BUYER:

​
		●	Complete manufacturing batch record of applicable bulk products,

		●	Certificate(s) of analysis of applicable APIs and of excipients,

		●	Certificate(s) of analysis of applicable primary packaging materials, and

		●	Test methods used.

​
		7.0
	Review of Batch Documentation:

​
7.1After detailed review of the batch documentation of each batch by SANDOZ, SANDOZ shall ensure that a statement of compliance with cGMP (Certificate of Compliance (“CoC”), is included or attached to the certificate of analysis (“CoA”) that is signed by a qualified person.
​
		7.2
	The CoC shall include at a minimum the following: batch identification, name and address of SANDOZ, date of manufacturing/release/expiration, confirmation that the batch was manufactured/tested in compliance with cGMP requirements and per the registered manufacturing process, confirmation that the batch records for the batch have been reviewed and followed SANDOZ procedures and cGMP requirements and signature of certification.

​
		8.0
	Deviations, Corrective and Preventive Actions:

​
8.1Deviation/failure investigations must be handled according to SANDOZ’s SOPs.
		8.2
	Critical or major deviations (or equivalent categories) that may have an impact on the release to the market decision or disrupt the supply shall be reported to BUYER prior to shipment.

	​

	​

	​

	​
	2
	​

​

​

		9.0
	Stability Testing:

​
9.1SANDOZ is responsible for maintaining a follow-up stability program under ICH conditions or as required by legislation. SANDOZ will investigate any stability failures and notify BUYER within [***] Business Days after discovery.
​
		10.0
	Distribution Product Complaints/Investigation Support:

​
10.1Upon receipt of complaint, SANDOZ shall attempt to warm transfer Complaint Reports to BUYER at [***]. If warm transfer is not possible, Sandoz shall provide all available complaint report information via secure e-mail with acknowledgment from the BUYER required as soon as possible.
10.2SANDOZ shall obtain appropriate contact information and event description regarding the complaint report and submit details of same to the BUYER via email at [***], within [***] Business Day of receipt by SANDOZ.
		10.3
	For any complaint requests, BUYER shall contact Sandoz via [***]. Upon request by BUYER, SANDOZ shall investigate complaints associated with the manufacturing of the Distribution Product. Within [***] calendar days after receipt, SANDOZ shall supply BUYER with an approved investigation document. A more urgent time period for investigations will be met for complaints which may represent a significant safety issue, as determined by BUYER and/or SANDOZ.

​
Exhibit C to the Asset Purchase Agreement - Quality Agreement
		11.0
	Adverse Events:

​
		11.1
	Refer directly to the Pharmacovigilance Agreement (as defined in the APA).

​
		12.0
	Recall:

​
12.1BUYER and SANDOZ will jointly agree on all decisions related to Distribution Product recalls, market withdrawals and field alerts concerning the finished Distribution Product. In the event that the Parties cannot agree, SANDOZ will decide on market action for SANDOZ labeled product. BUYER will be responsible for all associated Regulatory Authority notifications. SANDOZ shall be responsible for conducting, handling or processing recalls, withdrawals, and/or field corrections of and/or related to units of Distribution Products by SANDOZ based on safety, efficacy, failure to comply with cGMP, or similar concerns, with respect to any Distribution Products manufactured or distributed by SANDOZ during the Seller Distribution Term.
		12.2
	For any Product(s) sold by SANDOZ prior to the Closing Date, SANDOZ will be responsible for any recalls, market withdrawals and field alerts relating to such Product(s), and SANDOZ will be responsible for all associated Regulatory Authority notifications.

​
		13.0
	Warehouse:

​
		13.1
	SANDOZ shall, in compliance with Laws and per SANDOZ SOPs, ensure that starting materials and Distribution Products are stored under appropriate conditions of temperature and humidity, light and cleanliness so that identity, strength and purity are not affected. In the event that the quality of the materials/products in the warehouse could be adversely affected for any reason, SANDOZ shall take immediate action to prevent further damage. In any case, SANDOZ shall inform BUYER of such events and associated actions in writing within [***] Business Days.

​
​
​

	​

	​

	​

	​
	3
	​

​

​

		14.0
	Packaging for Dispatch and Transport:

​
		14.1
	SANDOZ is responsible for compliance with applicable Laws and SOPs related to the packaging, preparation for shipment/transport, and the shipment/transport of the Distribution Products.

​
		14.2
	If deviations are identified during shipment/transport for which SANDOZ is responsible, SANDOZ shall generate deviation reports and submit to the BUYER, including remediation efforts.

​
		15.0
	Release of Distribution Product:

​
		15.1
	The final release of the Distribution Product to the market is the responsibility of SANDOZ per this Quality Agreement.

​
		15.2
	SANDOZ shall comply with applicable Laws, including but not limited to, the requirements set forth per the Drug Supply Chain Security Act (H.R. 3204).

​
Exhibit C to the Asset Purchase Agreement - Quality Agreement
​
		16.0
	Audit:

​
		16.1
	During the term of this Quality Agreement, and for a period of no more than [***] year after the expiration date of the last batch the Distribution Products manufactured and sold by SANDOZ during the Seller Distribution Term, BUYER may audit SANDOZ for activities that SANDOZ performs under this Quality Agreement. Any such audit shall be conducted during regular business hours and at BUYER's cost. BUYER shall provide not less than [***] days advance written notice of its desire to conduct an audit to SANDOZ. SANDOZ shall not unreasonably withhold approval of such an audit. Prior to any audit, BUYER shall provide an audit plan/scope, which shall be reviewed and agreed upon by SANDOZ and BUYER. Following critical events that impact product quality/safety, Recalls or adverse FDA inspection and/or observation, BUYER may audit SANDOZ for activities that SANDOZ performs under this Quality Agreement. Any such audit shall be conducted during regular business hours and at BUYER's cost. Both parties agree to work collaboratively, and in a timely fashion to schedule audit.

​
		16.2
	SANDOZ will allow on-site access to facilities, procedures, and other documentation, related to the manufacture of the Distribution Products (including to subcontractors involved in such activities, if any). Audits shall not include access to SANDOZ's electronic systems. Any information from electronic systems will be provided to BUYER during on-site audit.

​
		17.0
	Key Contacts:

​
		17.1
	The names of the persons at BUYER and SANDOZ who are responsible for matters relating to manufacture of Distribution Products are set forth in the table below. If changes are made pertaining to these key contacts, the Party making such change shall, in a timely manner, inform the other Party in writing.

​
​
Exhibit C to the Asset Purchase Agreement - Quality Agreement
​
​

	​

	​

	​

	​
	4
	​

​

​

	

	

	

	

	Name/Title
	Site
	Telephone
	e-mail

	SANDOZ

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	BUYER

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

	[***]
	[***]
	[***]
	[***]

​
​
Exhibit C to the Asset Purchase Agreement - Quality Agreement
		18.0
	Terms of Expiry

​
		18.1
	This Quality Agreement shall expire upon expiration of the Seller Distribution Term.

​
		19.0
	Approvals:

​
	

	

	

	SANDOZ INC.
	    
	BUYER

	 
	 
	 

	 
	 
	 

	[***]
	 
	 

	 
	 
	 

	 
	 
	 

	[***]
	 
	 

	 
	 
	 

	 
	 
	 

	[***]
	 
	 

	 
	 
	 

	 
	 
	 

	[***]
	 
	 

​
​

	​

	​

	​

	​
	5
	​

​

​

	

	

	

	 
	    
	 

	 
	 
	 

	[***]
	 
	 

	 
	 
	 

	 
	 
	 

	[***]
	 
	 

	 
	 
	 

	 
	 
	 

	[***]
	 
	 

	 
	 
	 

	 
	 
	 

	[***]
	 
	 

​
Exhibit C to the Asset Purchase Agreement - Quality Agreement
​

	​

	​

	​

	​
	6
	​

​

​

Exhibit A: List of Distribution Products [***]
​
	

	

	

	

	

	ANDA number
	Product
	ANDA Approval status
	 Strength
	Seller to Distribute Product after Closing Date (Y/N)

	 
	185005301 - BENAZEPRIL 10MG 100FCT BO V1 US
	Approved
	10 mg
	[***]

	 
	185005305 - BENAZEPRIL 10MG 500FCT BO US
	Approved
	10 mg
	[***]

	 
	185050501 - BENAZEPRIL 5MG 100FCT BO V1 US
	Approved
	5 mg
	[***]

	76402
	185050505 - BENAZEPRIL 5MG 500FCT BO US
	Approved
	5 mg
	[***]

	 
	185082001 - BENAZEPRIL 20MG 100FCT BO V1 US
	Approved
	20 mg
	[***]

	 
	185082005 - BENAZEPRIL 20MG 500FCT BO US
	Approved
	20 mg
	[***]

	 
	185077101 - BISOP FUM 5MG 100FCT BO US
	Approved
	Tablet
	[***]

	75643
	185077130 - BISOP FUM 5MG 30FCT BO US
	Approved
	Tablet
	[***]

	 
	185077401 - BISOP FUM 10MG 100FCT BO US
	Approved
	Tablet
	[***]

	 
	185077430 - BISOP FUM 10MG 30FCT BO US
	Approved
	Tablet
	[***]

	 
	970663 - CEFPROZIL 500MG 100FCT BO US
	Approved
	500 mg
	[***]

	65257
	972156 - CEFPROZIL 500MG 50FCT BO US
	Approved
	500 mg
	[***]

	 
	972157 - CEFPROZIL 250MG 100FCT BO US
	Approved
	250 mg
	[***]

	 
	185012360 - CILOSTAZOL 50MG 60TAB BO US
	Approved
	50 mg
	[***]

	77310
	185022305 - CILOSTAZOL 100MG 500TAB BO US
	Approved
	100 mg
	[***]

	 
	185022360 - CILOSTAZOL 100MG 60TAB BO US
	Approved
	100 mg
	[***]

	75229
	501701 - DICLOFENAC POT 50MG 100FCT BO US
	Approved
	50 mg
	[***]

​
Exhibit C to the Asset Purchase Agreement - Quality Agreement
​
	

	

	

	

	

	74394
	178501 - DICLOFENAC SOD 25MG 100GRT BO US
	Approved
	25 mg
	[***]

	74376
	178901 - DICLOFENAC SOD 75MG 100GRT BO US
	Approved
	75 mg
	[***]

	74376
	44014930 - DICLOFENAC SOD 50MG 60GRT BO US
	Approved
	50 mg
	[***]

	 
	44014932 - DICLOFENAC SOD 75MG 60GRT BO US
	Approved
	75 mg
	[***]

	74394
	44014933 - DICLOFENAC SOD 75MG 500GRT BO US
	Approved
	75 mg
	[***]

	 
	44014934 - DICLOFENAC SOD 75MG 1000GRT BO US
	Approved
	75 mg
	[***]

	76075
	44049874 - ECONAZOLE NITRATE 1% 15G CRM US
	Approved
	1%
	[***]

	 
	44049875 - ECONAZOLE NITRATE 1% 30G CRM US
	Approved
	1%
	[***]

	 
	44049876 - ECONAZOLE NITRATE 1% 85G CRM US
	Approved
	1%
	[***]

	91659
	44063426 - HEPARIN SOD 5000IU/1ML 10LIVI US
	Approved
	5000 IU/mL
	[***]

​
Exhibit C to the Asset Purchase Agreement - Quality Agreement
​
	

	

	

	

	

	 
	44062559 - LISINOPRIL 10MG 1000TAB BO V5 US
	Approved
	10 mg
	[***]

	 
	44062579 - LISINOPRIL 20MG 1000TAB BO V5 US
	Approved
	20 mg
	[***]

	 
	44062580 - LISINOPRIL 2.5MG 1000TAB BO V2 US
	Approved
	2.5 mg
	[***]

	 
	44062581 - LISINOPRIL 20MG 100TAB BO V4 US
	Approved
	20 mg
	[***]

	 
	44062582 - LISINOPRIL 5MG 1000TAB BO V5 US
	Approved
	5 mg
	[***]

	 
	44062583 - LISINOPRIL 5MG 100TAB BO V3 US
	Approved
	5 mg
	[***]

	 
	44062584 - LISINOPRIL 2.5MG 100TAB BO V4 US
	Approved
	2.5 mg
	[***]

	 
	44062585 - LISINOPRIL 10MG 100TAB BO V4 US
	Approved
	10 mg
	[***]

	 
	44062590 - LISINOPRIL 40MG 1000TAB BO V5 US
	Approved
	40 mg
	[***]

	 
	44062592 - LISINOPRIL 30MG 100TAB BO V3 US
	Approved
	30 mg
	[***]

	75994
	44062593 - LISINOPRIL 40MG 100TAB BO V3 US
	Approved
	40 mg
	[***]

	 
	185540001 - LISINOPRIL 5MG 100TAB BO V1 US
	Approved
	5 mg
	[***]

	 
	185540010 - LISINOPRIL 5MG 1000TAB BO V2 US
	Approved
	5 mg
	[***]

	 
	44057665 - LISINOPRIL BPP 5MG 100TAB BO US
	Approved
	5 mg
	[***]

	 
	44057666 - LISINOPRIL BPP 5MG 1000TAB BO US
	Approved
	5 mg
	[***]

	 
	44066630 - LISINOPRIL BPP 40MG 1000TAB BO V1 US
	Approved
	40 mg
	[***]

	​

	​

	​

	​
	7
	​

​

​

	 
	44066631 - LISINOPRIL BPP 10MG 100TAB BO V1 US
	Approved
	10 mg
	[***]

	 
	44066632 - LISINOPRIL BPP 30MG 100TAB BO V1 US
	Approved
	30 mg
	[***]

	 
	44066633 - LISINOPRIL BPP 20MG 1000TAB BO V1 US
	Approved
	20 mg
	[***]

	 
	44066634 - LISINOPRIL BPP 10MG 1000TAB BO V1 US
	Approved
	10 mg
	[***]

	 
	44066635 - LISINOPRIL BPP 20MG 100TAB BO V1 US
	Approved
	20 mg
	[***]

	 
	44066638 - LISINOPRIL BPP 40MG 100TAB BO V1 US
	Approved
	40 mg
	[***]

​
​
Exhibit C to the Asset Purchase Agreement - Quality Agreement
​
	

	

	

	

	

	 
	185020501 - METHIMAZOLE 5MG 100TAB BO US
	Approved
	5 mg
	[***]

	 
	185020510 - METHIMAZOLE 5MG 1000TAB BO US
	Approved
	5 mg
	[***]

	40411
	185021001 - METHIMAZOLE 10MG 100TAB BO US
	Approved
	5 mg
	[***]

	 
	185021010 - METHIMAZOLE 10MG 1000TAB BO US
	Approved
	5 mg
	[***]

	 
	185004001 - MIDODRINE 2.5MG 100TAB BO US
	Approved
	2.5 mg
	[***]

	76514
	185004301 - MIDODRINE 5MG 100TAB BO US
	Approved
	5 mg
	[***]

	 
	185004305 - MIDODRINE 5MG 500TAB BO US
	Approved
	5 mg
	[***]

	 
	185014901 - MIDODRINE 10MG 100TAB BO US
	Approved
	10 mg
	[***]

	 
	185014501 - NABUMETONE 500MG 100FCT BO US
	Approved
	500 mg
	[***]

	75280
	185014505 - NABUMETONE 500MG 500FCT BO US
	Approved
	500 mg
	[***]

	 
	185014601 - NABUMETONE 750MG 100FCT BO US
	Approved
	750 mg
	[***]

	 
	185014605 - NABUMETONE 750MG 500FCT BO US
	Approved
	750 mg
	[***]

​
Exhibit C to the Asset Purchase Agreement - Quality Agreement
​
	

	

	

	

	

	90288
	44021447 - NARATRIPTAN 2.5MG 9FCT UD US
	Approved
	1 mg  &
2.5 mg
	[***]

	 
	167931 - ONDANSETRON HCL 4MG 30FCT BO US
	Approved
	4 mg
	[***]

	77517
	168131 - ONDANSETRON HCL 8MG 30FCT BO V1 US
	Approved
	8 mg
	[***]

	 
	44013938 - ONDANSETRON HCL 4MG 3FCT UD V1 US
	Approved
	4 mg
	[***]

	 
	44014642 - REPAGLINIDE 0.5MG 100TAB BO US
	Approved
	0.5 mg
	[***]

	78555
	44014643 - REPAGLINIDE 1MG 100TAB BO US
	Approved
	1 mg
	[***]

	 
	44014644 - REPAGLINIDE 2MG 100TAB BO US
	Approved
	2 mg
	[***]

	76192
	204316 - RIBAVIRIN 200MG 56HGC BO US
	Approved
	200 mg
	[***]

​
​

	​

	​

	​

	​
	8
	​

​

​

	 
	159901 - SPIRONOLACTONE 25MG 100FCT BO US
	Approved
	25 mg
	[***]

	86809
	159905 - SPIRONOLACTONE 25MG 500FCT BO US
	Approved
	25 mg
	[***]

	 
	159910 - SPIRONOLACTONE 25MG 1000FCT BO US
	Approved
	25 mg
	[***]

	 
	185003410 - TIZANIDINE 2MG 1000TAB BO US
	Approved
	2 mg
	[***]

	 
	185003451 - TIZANIDINE 2MG 150TAB BO US
	Approved
	2 mg
	[***]

	76280
	185440010 - TIZANIDINE 4MG 1000TAB BO US
	Approved
	4 mg
	[***]

	 
	185440023 - TIZANIDINE 4MG 300TAB BO US
	Approved
	4 mg
	[***]

	 
	185440051 - TIZANIDINE 4MG 150TAB BO US
	Approved
	4 mg
	[***]

	73191
	271501 - TRIAM/HCT 50+25MG 100HGC BO US
	Approved
	50/25 mg
	[***]

	203489
	Telmisartan and Hydrochlorothiazide Tabs
	Pending
	40 mg/12.5 mg - NDC 0781-5391-64 in unit dose pack of 30 tablets (3 x 10 unit-dose)
	[***]

				 
	
				80 mg/12.5 mg - NDC 0781-5392-64 in unit dose pack of 30 tablets (3 x 10 unit-dose)
	
				 
	
				80 mg/25 mg - NDC 0781-5393-64 in unit dose pack of 30 tablets (3 x 10 unit-dose)
	
	78611
	Aripiprazole Tablets, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
	Pending
	 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
	[***]

	206080
	Bepotastine Oph Solution 1.5%
	Tentatively Approved.  PIII till September 2024
	1.50%
	[***]

​
​
Exhibit C to the Asset Purchase Agreement - Quality Agreement
​
	

	

	

	

	

	204028
	Desvenlafaxine
	Approved
	100 mg:  30, 90, 1000
	[***]

	206672
	Entecavir Tablets  0.5 mg and 1 mg
	Approved
	0.5 mg and 1 mg
	[***]

	203746
	Bromfenac Oph Solution, 0.09%
	Pending
	0.09%
	[***]

	203384
	Epinastine HCl Ophthalmic  Solution,  0.05%
	Approved
	0.05%
	[***]

	90279
	Burprenorphine HCL SLT
	Approved
	 
	[***]

​
​

	​

	​

	​

	​
	9
	​

​

​

Exhibit D
​
Form of Assignment and Assumption Agreement for Intellectual Property Agreement(s)
​
THIS ASSIGNMENT AND ASSUMPTION AGREEMENT (this “Assignment”) is made as of this ____ day of _____________, 201_ (the “Effective Date”), by and between Sandoz Inc., a Colorado corporation, with offices at 100 College Road West, Princeton, new Jersey 08540 (“Assignor”) and CASI Pharmaceuticals, Inc., a Delaware corporation, with offices at 9620 Medical Center Drive, #300, Rockville, Maryland 20850 (“Assignee”). Assignor and Assignee are each referred to individually as a “Party” and together as the “Parties.”
​
W I T N E S S E T H :
​
WHEREAS, on _______________, Assignor and ___________, entered into that certain ______________ (the “Agreement”);
​
WHEREAS, Assignor and Assignee are parties to that certain Asset Purchase Agreement, dated as of the 26th day of January, 2018 (the “APA”);
​
WHEREAS, Assignor desires to assign to Assignee, and Assignee desires to assume from Assignor, all of Assignor's rights, obligations, debts and liabilities under, or related to, the Agreement, with effect from the Effective Date on the terms of this Assignment.
​
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, and as more fully set forth in the APA and subject to the terms and conditions therein, Assignor and the Assignee intending to be legally bound, agree as follows:
​
	1.
	Assignment.

​
		a.
	Assignor hereby assigns and transfers absolutely to Assignee the Agreement and all of its: (i) rights under the Agreement; and (ii) obligations, debts and liabilities under, or related to, the Agreement (“Liabilities”) relating to periods on or after the Effective Date; and

​
		b.
	Assignee shall enjoy all the rights and benefits of Assignor under the Agreement with effect from the Effective Date, and all references to Assignor in the Agreement shall be read and construed as references to Assignee.

​
	2.
	Assumption. Assignee hereby accepts the assignment of the Agreement and all of Assignor’s rights under the Agreement, and with effect from the Effective Date, agrees to assume and discharge and perform when due all of Assignor’s Liabilities as if Assignee were, and had originally been, a party to the Agreement in place of Assignor.

​

	​

	​

	​

	​
	10
	​

​

​

		3.
	Liabilities. Nothing in this Assignment shall be construed as: (a) requiring Assignee to observe, perform or discharge any obligation created by or arising under the Agreement falling due for performance, or which should have been performed, before the Effective Date; or (b) making Assignee liable for any liabilities, claims or demands arising in relation to the Agreement to the extent they have arisen or arise (whether before or after the Effective Date) as a result of, or otherwise relate to an act, omission, fact, matter, circumstance or event undertaken, occurring, in existence or arising before the Effective Date.

		4.
	Successors and Assigns. The terms and provisions hereof shall inure to the benefit of, and be binding upon the Parties and their respective successors and permitted assigns. No Party shall assign, encumber or otherwise transfer this Assignment or any part of it to any Third Party, without the prior written consent of the other Party which consent will not be unreasonably withheld; provided, however, that notwithstanding the foregoing, no such consent shall be required in the event of any assignment or transfer of this Assignment (a) to any of its affiliates, or (b) to any successor in interest to such Party’s business, whether by merger, sale of assets or otherwise; in the event of which a Party shall only be required to give written notice of such assignment or transfer to the other Party but will not be required to obtain the consent of the other Party. In the case of any assignment or other transfer, the assigning Party shall remain liable for the full and timely performance of the transferee.

		5.
	Severability. Should any part or provision of this Assignment be held unenforceable or in conflict with applicable law, the invalid or unenforceable part or provision shall, provided that it does not affect the essence of this Assignment, be replaced with a revision which accomplishes, to the greatest extent possible, the original commercial purpose of such part or provision in a valid and enforceable manner, and the balance of this Assignment shall remain in full force and effect and binding upon the Parties hereto.

		6.
	Arbitration. Any disputes arising out of or in connection with this Assignment shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by three arbitrators appointed in accordance with the rules. The legal place of arbitration shall be New York, NY, USA. The language of the arbitration shall be English.

		7.
	Governing Law; English Language. This Assignment shall be governed, interpreted and construed in accordance with the substantive laws of the State of Delaware, U.S.A., without regard to its conflict of laws principles. To the extent that it may otherwise be applicable, the Parties hereby expressly agree to unconditionally waive and exclude from the operation of this Agreement the United Nations Convention on Contracts for the International Sale of Goods, concluded at Vienna, on 11 April 1980, as amended and as may be amended further from time to time. This Assignment has been negotiated and drafted by the Parties in the English language. Any translation into any other language shall not be an official version thereof. In the event any translation of this Agreement is prepared for convenience or for any other purpose, the provisions of the English version shall prevail.

		8.
	Counterparts; PDF. This Assignment may be executed in two (2) or more counterparts, each of which shall be deemed an original but all of which, taken together, shall constitute one and the same instrument. PDF and facsimile signatures shall constitute original signatures. The Parties agree that the electronic signatures appearing on this Assignment are the same as handwritten signatures for the purposes of validity, enforceability and admissibility pursuant to the Electronic Signatures in Global and National Commerce (ESIGN) Act of 2000, and Uniform Electronic Transactions Act (UETA) model law, or similar Applicable Laws.

	​

	​

	​

	​
	11
	​

​

​

IN WITNESS WHEREOF, the Parties hereto have executed this Assignment as of the Effective Date.
​
	

	

	

	CASI PHARMACEUTICALS, INC.

	 
	 
	 

	 
	 
	 

	By:
	 
	 

	 
	 
	 

	Name:
	 
	 

	 
	 
	 

	Title:
	 
	 

	 
	 
	 

	 
	 
	 

	SANDOZ INC.

	 
	 
	 

	 
	 
	 

	By:
	 
	 

	 
	 
	 

	Name:
	 
	 

	 
	 
	 

	Title:
	 
	 

​
​

	​

	​

	​

	​
	12
	​

​

​

Exhibit E
​
Form of Seller FDA Letter
​
<DATE>
​
Office of Generic Drugs, HFD-600
Center for Drug Evaluation and Research
Food and Drug Administration
Document Control Room
7620 Standish Place
Rockville, MD 20855
​
	TRANSFER
	    
	OF
	    
	OWNERSHIP

​
Divestiture
​
		Reference:
	<PRODUCT NAME>

​
ANDA # <NUMBER>
​
In accordance with 21 CFR §314.72(a)(1), Sandoz Inc. hereby notifies the Agency that we are transferring ownership, including all rights to ANDA <NUMBER> for <PRODUCT NAME> to <COMPANY NAME> The change in ownership is effective as of <DATE> and all rights of ownership for the referenced ANDA have been transferred to:
​
<COMPANY NAME>
<CONTACT NAME>
<ADDRESS LINE 1>
<ADDRESS LINE 2>
<TELEPHONE>
<FAX>
<EMAIL>
​
This submission is being sent to the Agency through the Electronic Submissions Gateway (ESG). The submission is presented in electronic format and is comprised of approximately 1 megabyte.
​
This document contains trade secrets and/or confidential commercial information and is therefore exempt from disclosure under the Freedom of Information Act and FDA implementing regulations.
​
If there are any questions regarding the content of this submission, please contact <CONTACT NAME> at <TELEPHONE NUMBER>, or via facsimile at <NUMBER> or e-mail:<EMAIL ADDRESS>.
​
Sincerely,
​
<CONTACT INFORMATION>
​
Form of Buyer FDA Letter
​
Buyer ANDA Letter
​
<DATE>
​
	

	

	Office of Generic Drugs, HFD-600
	 

	Center for Drug Evaluation and Research
	Sequence: <NUMBER>

	Food and Drug Administration
	 

	Document Control Room
	 

	7620 Standish Place
	 

	Rockville, MD 20855
	 

​

​

​

- General Correspondence – Acceptance of Ownership -
​
		Reference:
	ANDA <NUMBER>

​
<PRODUCT NAME>
​
Reference is made to Sandoz Inc.’s (“Sandoz”) approved Abbreviated New Drug Application for <PRODUCT NAME>.
​
Reference is also made to <COMPANY’S NAME> <DATE> Transfer of Ownership of ANDA <NUMBER> in which they notified the Agency that ownership has been transferred to <COMPANY NAME>.
​
In accordance with 21 CFR 314.72(a)(2) <COMPANY NAME> is notifying the Agency that on <DATE> <COMPANY NAME> became the owner of ANDA <NUMBER>. In addition, a complete copy of the application was received from <COMPANY> on <DATE>. Furthermore, <COMPANY> hereby commits to abide by the agreements, commitments, and conditions currently contained in the application. If changes do arise from the transfer Sandoz will submit these changes to the application, as applicable.
​
<COMPANY> contact information is as follows:
​
	Name:
	 

	Title:
	 

	Address
	 

	Telephone Number:
	 

	Fax Number:
	 

	Email:
	 

​
This correspondence is being submitted via the electronic submission gateway. The size of the submission is approximately 5 MB. This submission is virus free. The files were scanned for virus using McAfee Virus Scan Enterprise Version 8.5i.
​
This document contains trade secrets and/or confidential commercial information and is therefore exempt from disclosure under the Freedom of Information Act and FDA implementing regulations.
​
If there are any questions regarding the content of this submission, please contact <CONTACT NAME> at <TELEPHONE NUMBER>, or via facsimile at <NUMBER> or e-mail:<EMAIL ADDRESS>.
​
Sincerely,
​
<CONTACT INFORMATION>
​
​

​

​

Exhibit F
​
Transition Agreement
​
[See attached]
​
Executive Version
​
TRANSITION AGREEMENT
​
between
​
CASI PHARMACEUTICALS, INC.
and
​
SANDOZ INC.
​
and
​
Dated as of January 26, 2018
​
TRANSITION AGREEMENT
​
This TRANSITION AGREEMENT (this “Agreement”) is made as of this 26th day of January, 2018, by and between Sandoz Inc., a Colorado corporation, with offices at 100 College Road West, Princeton, New Jersey 08540 (“Sandoz”), and CASI Pharmaceuticals, Inc., a Delaware corporation, with offices at 9620 Medical Center Drive, Rockville, MD 20850 (“Buyer”). Sandoz and Buyer are each referred to individually as a “Party” and together as the “Parties.”
​
RECITALS
​
WHEREAS, Sandoz and Buyer are parties to that certain Asset Purchase Agreement, dated even with the date hereof (as such agreement may be amended from time to time, the “APA”); and
​
WHEREAS, the APA provides that Sandoz shall provide Buyer with certain assistance, information and knowledge to effect a transfer of the Purchased Assets from Sandoz to Buyer, and that the Parties (or their Affiliates) will enter into this Agreement on the Closing Date to provide for additional transition assistance.
​
NOW, THEREFORE, in consideration of the foregoing and the covenants and agreements set forth below, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
​
1.       DEFINITIONS
​
The capitalized terms used in this Agreement shall have the meanings as defined below or, if not defined below, as defined in the APA:
​
“[***]” shall have the meaning ascribed to it in Section 2.1.
​
“Tech Transfer Services” shall have the meaning ascribed to it in Section 2.1.
​
“Term” shall have the meaning ascribed to it in Section 3.
​
2.       SERVICES TO BE PERFORMED
​
2.1 Tech Transfer Services. Sandoz shall use commercially reasonable efforts to cause appropriate employees and representatives to discuss Buyer’s inquiries and respond to Buyer’s written queries specifically relating to the Technical Transfer Documentation upon reasonable request during the Term (the “Tech Transfer Services”). Sandoz shall arrange for an in-person meeting at its [***] manufacturing site (“[***]”) to answer questions about the Technical Transfer Documentation promptly after the closing at a time to be mutually agreed with Buyer, but not later than [***] Business Days after the Closing Date.

	​

	​

	​

	​
	1
	​

​

​

​
2.2 Responsibilities. Sandoz shall perform the Tech Transfer Services in a [***] manner, and in accordance with this Agreement and the standards that Sandoz would normally use to accomplish a similar objective under similar circumstances exercising reasonable business judgment. Sandoz shall devote that portion of Sandoz's business time, attention, skill and energy as may be reasonably necessary to support the Tech Transfer Services, but in no event shall Sandoz be required to devote more hours than the amounts listed in Section 4.1 below. Sandoz shall provide sufficiently skilled and experienced staff necessary to perform the Tech Transfer Services. Notwithstanding the foregoing, Buyer acknowledges that nothing in this Agreement shall require Sandoz to retain any specific personnel, or that shall limit or restrict the right of Sandoz to restructure or change its manufacturing operations.
​
2.3 Coordination. Sandoz shall appoint one individual, to serve as the project manager overseeing the provision of Tech Transfer Services by Sandoz. Such project manager shall coordinate the collection of questions and requests for information from Buyer personnel, and shall ensure that such questions and requests for information are fully addressed by Sandoz personnel. Buyer agrees that all communications to Sandoz by Buyer must be made through such project manager. Sandoz in its sole discretion may from time to time designate a different individual to serve as such project manager.
​
3.       TERM
​
The term of this Agreement shall commence as of the date of this Agreement and, unless sooner terminated in accordance with this Agreement, shall continue for a period of: [***] (the “Term”). Upon the effective date of termination of this Agreement, the obligations and liabilities of each Party to the other shall cease and terminate, and this Agreement shall be of no further force or effect, except as otherwise provided herein.
​
4.       COMPENSATION
​
During the Term, in addition to the meeting referenced in the last sentence of Section 2.1, Sandoz shall perform not more than [***] of Tech Transfer Services, not to exceed [***], as reasonably requested by Buyer. [***]. Sandoz shall submit to Buyer an invoice within [***] Business Days of the end of each month of this Agreement setting forth in reasonable detail all hours worked by each individual providing such Tech Transfer Services to Buyer and a description of the services performed by such individual.
​
5.       EXPENSES.
​
Buyer shall reimburse Sandoz for all reasonable out-of-pocket expenses, subject to any required approvals pursuant to the next sentence, incurred by Sandoz in rendering the Tech Transfer Services (collectively, the “Expenses”). All Expenses exceeding [***] per month in the aggregate or [***] individually shall require the prior written approval of Buyer in order to be reimbursed. All reimbursement requests for out-of-pocket Expenses shall be submitted not later than [***] days after the expiration of the Term, together with copies of such supporting documentation as may be reasonably requested by Buyer.
​
6.       RESERVED
​
7.       ETHICAL CONDUCT AND COMPLIANCE WITH LAWS
​
Sandoz agrees to perform Sandoz’s responsibilities under this Agreement in accordance with the [***]. Sandoz shall comply with all laws, rules and regulations, whether federal, state or local, in the Territory, that are applicable to Sandoz providing Buyer the Tech Transfer Services.
​
8.       CONFLICTS
​
Each Party represents, warrants and covenants that it is not, and shall not become, a party to any contract or other agreement with any other Person that would interfere with or prevent such Party from complying with the terms and provisions of this Agreement.
​
​
9.       STATUS OF SANDOZ
​
In rendering services pursuant to this Agreement, Sandoz shall be an independent contractor. As an independent contractor, Sandoz shall have no authority, express or implied, to commit or obligate Buyer in any manner whatsoever. Nothing contained in this Agreement shall be construed or applied to create a partnership or joint venture.
​
10.       TERMINATION
​
10.1       For Cause. [***].

	​

	​

	​

	​
	2
	​

​

​

​
10.2       Without Cause. [***].
​
10.3       Survival Upon Termination. The provisions of Sections 10 (Termination), 12 (Notices) and 13 (Miscellaneous) shall survive any termination of this Agreement.
​
10.4       Effect of Termination. Any termination of this Agreement shall not affect either Party’s rights or obligations with respect to payments of compensation, costs or expenses incurred or due for Tech Transfer Services performed prior to the date of termination.
​
11.       RESERVED
​
12.       NOTICES
​
All notices and other communications required or permitted to be given or made pursuant to this Agreement shall be in writing signed by the sender and shall be deemed duly given (a) on the date delivered, if personally delivered, (b) on the date sent by telecopier with automatic confirmation by the transmitting machine showing the proper number of pages were transmitted without error, (c) on the Business Day after being sent by Federal Express or another recognized overnight mail service which utilizes a written form of receipt for next day or next Business Day delivery or (d) three (3) Business Days after mailing, if mailed by U.S. postage-prepaid certified or registered mail, return receipt requested, in each case addressed to the applicable Party at the address set forth below; provided that a Party may change its address for receiving notice by the proper giving of notice hereunder:
​
if to Seller, to:
​
Sandoz Inc.
100 College Road West
Princeton, New Jersey 08540
Attention: President
​
With a copy (which shall not constitute notice) to:
​
Sandoz Inc.
100 College Road West
Princeton, New Jersey 08540
Attention: General Counsel
​
if to Buyer, to:
​
CASI Pharmaceuticals, Inc.
9620 Medical Center Drive #300
Rockville, Maryland 20850
Attention: Chief Executive Officer
​
With a copy (which shall not constitute notice) to:
​
CASI Pharmaceuticals, Inc.
9620 Medical Center Drive #300
Rockville, Maryland 20850
Attention: General Counsel
​
13.       MISCELLANEOUS
​
13.1       Governing Law and Jurisdiction. The laws of the State of Delaware shall govern the validity and construction of this Agreement and all rights and obligations of, and disputes between the Parties arising out of or related to this Agreement or the transactions contemplated by this Agreement, whether in contract, tort or otherwise, without regard to the principles of conflict of laws of the State of Delaware. The Parties submit to the jurisdiction of all state and federal courts sitting in the State of Delaware for all actions and proceedings arising out of or relating to this Agreement.
​

	​

	​

	​

	​
	3
	​

​

​

13.2       Taxes. [***] shall be fully responsible for payment of all income taxes, social security taxes, and for any other taxes or payment which may be due and owing by [***] as the result of fees or amounts paid to it by [***] under this Agreement, and [***] shall indemnify and hold harmless [***] from and against any such tax or payment.
​
13.3       WAIVER OF RIGHT TO JURY TRIAL. BY EXECUTING THIS AGREEMENT, THE PARTIES KNOWINGLY AND WILLINGLY WAIVE ANY RIGHT THEY HAVE UNDER APPLICABLE LAW TO A TRIAL BY JURY IN ANY DISPUTE ARISING OUT OF OR IN ANY WAY RELATED TO THIS AGREEMENT OR THE ISSUES RAISED BY THAT DISPUTE.
​
13.4       Miscellaneous. This Agreement may be amended, waived, changed, modified or discharged only by an agreement in writing signed by all of the Parties. The terms and provisions hereof shall inure to the benefit of, and be binding upon the Parties and their respective successors and permitted assigns. No Party shall assign, encumber or otherwise transfer this Agreement or any part of it to any Third Party, without the prior written consent of the other Party which consent will not be unreasonably withheld; provided, however, that notwithstanding the foregoing, no such consent shall be required in the event of any assignment or transfer of this Agreement (a) by either Party to any of its Affiliates, or (b) by either Party, to any successor in interest to all or any part of such Party’s business, whether by merger, sale of assets or otherwise; in the event of which a Party shall only be required to give written notice of such assignment or transfer to the other Party but will not be required to obtain the consent of the other Party. In the case of any sale, assignment, divestiture or other transfer, the assigning Party shall remain liable for the full and timely performance of the transferee. This Agreement may be executed and delivered by facsimile signature or other electronic format and in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. In the event that any section or any part of a section of this Agreement should be declared void, invalid, or unenforceable by any court of law, for any reason, such a determination shall not render void, invalid, or unenforceable any other section or any part of any other section of this Agreement and the remainder of this Agreement shall remain in full force and effect. No delay by or omission of any Party in exercising any right, power, privilege, or remedy shall impair such right, power, privilege, or remedy or be construed as a waiver thereof.
​
​
[Signature Page Follows]
​
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first above set forth.
​
	​

	​

	​

	​

	​

	CASI PHARMACEUTICALS, INC.
	    
	SANDOZ INC

	 
	 
	 
	 
	 

	 
	 
	 
	 
	 

	 
	 
	 
	 
	 

	By:
	 
	 
	By:
	 

	Name:
	[***]
	 
	Name:
	 

	Title:
	[***]
	 
	Title:
	 

​
​
​

	​

	​

	​

	​
	4
	​

​

​

Exhibit G
​
Technical Transfer Documentation
​
	

	

	Document Name
	Description of Document

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

​
​

​

​

SCHEDULES
​
	Schedule 1.3 
	   
	ANDAs

	 
	 
	 

	Schedule 1.4
	 
	API Provider and Excipient Vendor List

	 
	 
	 

	Schedule 1.44
	 
	Raw Materials

	 
	 
	 

	Schedule 1.48
	 
	Sample Product

	 
	 
	 

	Schedule 1.50
	 
	Seller’s Knowledge

	 
	 
	 

	Schedule 6.2.2.2
	    
	Settled, Dismissed, Pending or Threatened ANDA Infringement Claims

	 
	 
	 

	Schedule 6.2.3.1
	 
	Pending Legal Proceedings

	 
	 
	 

	Schedule 6.2.3.2
	 
	Prior Legal Proceedings

	 
	 
	 

	Schedule 6.2.5
	 
	Recalls

​
​
​

​

​

Schedule 1.3
​
ANDAs
​
	

	

	

	

	

	ANDA number
	Product
	ANDA Approval status
	 Strength
	Seller to Distribute Product after Closing Date (Y/N)

	 
	185005301 - BENAZEPRIL 10MG 100FCT BO V1 US
	Approved
	10 mg
	[***]

	 
	185005305 - BENAZEPRIL 10MG 500FCT BO US
	Approved
	10 mg
	[***]

	 
	185050501 - BENAZEPRIL 5MG 100FCT BO V1 US
	Approved
	5 mg
	[***]

	76402
	185050505 - BENAZEPRIL 5MG 500FCT BO US
	Approved
	5 mg
	[***]

	 
	185082001 - BENAZEPRIL 20MG 100FCT BO V1 US
	Approved
	20 mg
	[***]

	 
	185082005 - BENAZEPRIL 20MG 500FCT BO US
	Approved
	20 mg
	[***]

	 
	185077101 - BISOP FUM 5MG 100FCT BO US
	Approved
	Tablet
	[***]

	75643
	185077130 - BISOP FUM 5MG 30FCT BO US
	Approved
	Tablet
	[***]

	 
	185077401 - BISOP FUM 10MG 100FCT BO US
	Approved
	Tablet
	[***]

	 
	185077430 - BISOP FUM 10MG 30FCT BO US
	Approved
	Tablet
	[***]

	 
	970663 - CEFPROZIL 500MG 100FCT BO US
	Approved
	500 mg
	[***]

	65257
	972156 - CEFPROZIL 500MG 50FCT BO US
	Approved
	500 mg
	[***]

	 
	972157 - CEFPROZIL 250MG 100FCT BO US
	Approved
	250 mg
	[***]

	 
	185012360 - CILOSTAZOL 50MG 60TAB BO US
	Approved
	50 mg
	[***]

	77310
	185022305 - CILOSTAZOL 100MG 500TAB BO US
	Approved
	100 mg
	[***]

	 
	185022360 - CILOSTAZOL 100MG 60TAB BO US
	Approved
	100 mg
	[***]

​
​

​

​

	

	

	

	

	

	75229
	501701 - DICLOFENAC POT 50MG 100FCT BO US
	Approved
	50 mg
	[***]

	74394
	178501 - DICLOFENAC SOD 25MG 100GRT BO US
	Approved
	25 mg
	[***]

	74376
	178901 - DICLOFENAC SOD 75MG 100GRT BO US
	Approved
	75 mg
	[***]

	74376
	44014930 - DICLOFENAC SOD 50MG 60GRT BO US
	Approved
	50 mg
	[***]

	 
	44014932 - DICLOFENAC SOD 75MG 60GRT BO US
	Approved
	75 mg
	[***]

	74394
	44014933 - DICLOFENAC SOD 75MG 500GRT BO US
	Approved
	75 mg
	[***]

	 
	44014934 - DICLOFENAC SOD 75MG 1000GRT BO US
	Approved
	75 mg
	[***]

	76075
	44049874 - ECONAZOLE NITRATE 1% 15G CRM US
	Approved
	1%
	[***]

	 
	44049875 - ECONAZOLE NITRATE 1% 30G CRM US
	Approved
	1%
	[***]

	 
	44049876 - ECONAZOLE NITRATE 1% 85G CRM US
	Approved
	1%
	[***]

	91659
	44063426 - HEPARIN SOD 5000IU/1ML 10LIVI US
	Approved
	5000 IU/mL
	[***]

	 

	44062559 - LISINOPRIL 10MG 1000TAB BO V5 US

	Approved

	10 mg

	[***]

	 
	44062579 - LISINOPRIL 20MG 1000TAB BO V5 US
	Approved
	20 mg
	[***]

	 
	44062580 - LISINOPRIL 2.5MG 1000TAB BO V2 US
	Approved
	2.5 mg
	[***]

	 
	44062581 - LISINOPRIL 20MG 100TAB BO V4 US
	Approved
	20 mg
	[***]

	 
	44062582 - LISINOPRIL 5MG 1000TAB BO V5 US
	Approved
	5 mg
	[***]

	 
	44062583 - LISINOPRIL 5MG 100TAB BO V3 US
	Approved
	5 mg
	[***]

	 
	44062584 - LISINOPRIL 2.5MG 100TAB BO V4 US
	Approved
	2.5 mg
	[***]

	 
	44062585 - LISINOPRIL 10MG 100TAB BO V4 US
	Approved
	10 mg
	[***]

	 
	44062590 - LISINOPRIL 40MG 1000TAB BO V5 US
	Approved
	40 mg
	[***]

	 
	44062592 - LISINOPRIL 30MG 100TAB BO V3 US
	Approved
	30 mg
	[***]

	75994
	44062593 - LISINOPRIL 40MG 100TAB BO V3 US
	Approved
	40 mg
	[***]

	 
	185540001 - LISINOPRIL 5MG 100TAB BO V1 US
	Approved
	5 mg
	[***]

	 
	185540010 - LISINOPRIL 5MG 1000TAB BO V2 US
	Approved
	5 mg
	[***]

	 
	44057665 - LISINOPRIL BPP 5MG 100TAB BO US
	Approved
	5 mg
	[***]

	 
	44057666 - LISINOPRIL BPP 5MG 1000TAB BO US
	Approved
	5 mg
	[***]

	 
	44066630 - LISINOPRIL BPP 40MG 1000TAB BO V1 US
	Approved
	40 mg
	[***]

	 
	44066631 - LISINOPRIL BPP 10MG 100TAB BO V1 US
	Approved
	10 mg
	[***]

	 
	44066632 - LISINOPRIL BPP 30MG 100TAB BO V1 US
	Approved
	30 mg
	[***]

	 
	44066633 - LISINOPRIL BPP 20MG 1000TAB BO V1 US
	Approved
	20 mg
	[***]

	 
	44066634 - LISINOPRIL BPP 10MG 1000TAB BO V1 US
	Approved
	10 mg
	[***]

	 
	44066635 - LISINOPRIL BPP 20MG 100TAB BO V1 US
	Approved
	20 mg
	[***]

	 
	44066638 - LISINOPRIL BPP 40MG 100TAB BO V1 US
	Approved
	40 mg
	[***]

	 
	185020501 - METHIMAZOLE 5MG 100TAB BO US
	Approved
	5 mg
	[***]

	 
	185020510 - METHIMAZOLE 5MG 1000TAB BO US
	Approved
	5 mg
	[***]

	40411
	185021001 - METHIMAZOLE 10MG 100TAB BO US
	Approved
	5 mg
	[***]

	 
	185021010 - METHIMAZOLE 10MG 1000TAB BO US
	Approved
	5 mg
	[***]

	 
	185004001 - MIDODRINE 2.5MG 100TAB BO US
	Approved
	2.5 mg
	[***]

	76514
	185004301 - MIDODRINE 5MG 100TAB BO US
	Approved
	5 mg
	[***]

	 
	185004305 - MIDODRINE 5MG 500TAB BO US
	Approved
	5 mg
	[***]

	 
	185014901 - MIDODRINE 10MG 100TAB BO US
	Approved
	10 mg
	[***]

	 
	185014501 - NABUMETONE 500MG 100FCT BO US
	Approved
	500 mg
	[***]

	75280
	185014505 - NABUMETONE 500MG 500FCT BO US
	Approved
	500 mg
	[***]

	 
	185014601 - NABUMETONE 750MG 100FCT BO US
	Approved
	750 mg
	[***]

	 
	185014605 - NABUMETONE 750MG 500FCT BO US
	Approved
	750 mg
	[***]

​
​
	90288
	44021447 - NARATRIPTAN 2.5MG 9FCT UD US
	Approved
	1 mg  & 2.5 mg
	[***]

	 
	167931 - ONDANSETRON HCL 4MG 30FCT BO US
	Approved
	4 mg
	[***]

​

​

	77517
	168131 - ONDANSETRON HCL 8MG 30FCT BO V1 US
	Approved
	8 mg
	[***]

	 
	44013938 - ONDANSETRON HCL 4MG 3FCT UD V1 US
	Approved
	4 mg
	[***]

	 
	44014642 - REPAGLINIDE 0.5MG 100TAB BO US
	Approved
	0.5 mg
	[***]

	78555
	44014643 - REPAGLINIDE 1MG 100TAB BO US
	Approved
	1 mg
	[***]

	 
	44014644 - REPAGLINIDE 2MG 100TAB BO US
	Approved
	2 mg
	[***]

	76192
	204316 - RIBAVIRIN 200MG 56HGC BO US
	Approved
	200 mg
	[***]

	 
	159901 - SPIRONOLACTONE 25MG 100FCT BO US
	Approved
	25 mg
	[***]

	86809
	159905 - SPIRONOLACTONE 25MG 500FCT BO US
	Approved
	25 mg
	[***]

	 

	159910 - SPIRONOLACTONE 25MG 1000FCT BO US

	Approved

	25 mg

	[***]

	 
	185003410 - TIZANIDINE 2MG 1000TAB BO US
	Approved
	2 mg
	[***]

	 
	185003451 - TIZANIDINE 2MG 150TAB BO US
	Approved
	2 mg
	[***]

	76280
	185440010 - TIZANIDINE 4MG 1000TAB BO US
	Approved
	4 mg
	[***]

	 
	185440023 - TIZANIDINE 4MG 300TAB BO US
	Approved
	4 mg
	[***]

	 
	185440051 - TIZANIDINE 4MG 150TAB BO US
	Approved
	4 mg
	[***]

	73191
	271501 - TRIAM/HCT 50+25MG 100HGC BO US
	Approved
	50/25 mg
	[***]

	203489
	Telmisartan and Hydrochlorothiazide Tabs
	Pending
	40 mg/12.5 mg - NDC 0781-5391-64 in unit dose pack of 30 tablets (3 x 10 unit-dose)
	[***]

				 
	
				80 mg/12.5 mg - NDC 0781-5392-64 in unit dose pack of 30 tablets (3 x 10 unit-dose)
	
				 
	
				80 mg/25 mg - NDC 0781-5393-64 in unit dose pack of 30 tablets (3 x 10 unit-dose)
	
	78611
	Aripiprazole Tablets, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
	Pending
	 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
	[***]

	206080
	Bepotastine Oph Solution 1.5%
	Tentatively Approved.  PIII till September 2024
	1.50%
	[***]

	204028
	Desvenlafaxine
	Approved
	100 mg:  30, 90, 1000
	[***]

	206672
	Entecavir Tablets  0.5 mg and 1 mg
	Approved
	0.5 mg and 1 mg
	[***]

	203746
	Bromfenac Oph Solution, 0.09%
	Pending
	0.09%
	[***]

	203384
	Epinastine HCl Ophthalmic  Solution,  0.05%
	Approved
	0.05%
	[***]

	90279
	Burprenorphine HCL SLT
	Approved
	 
	[***]

​
​

​

​

Schedule 1.4
​
API Provider and Excipient Vendor List
​
	Component Description
	Component Manufacturer Name

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

​
​

​

​

​
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

​
​

​

​

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

​
​

​

​

​
	

	

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

​
​

​

​

	

	

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

​
​

​

​

	

	

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

​
​

​

​

​
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

​
​

​

​

​
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		

​

​

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

​
​

​

​

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	[***]
	[***]

	[***]
	[***]

​
​

​

​

	

	

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

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​
​

​

​

​
	

	

	[***]
	[***]

	[***]
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	[***]
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​
​
​

​

​

Schedule 1.44
​
Raw Materials
​
	

	

	Material Description
	QTY (KG)

	[***]
	[***]

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​
​

​

​

Schedule 1.48
​
Sample Product
​
	

	

	Material Description
	Number of units in one case

	BENAZEPRIL 10MG 100FCT BO V1 US
	[***]

	BENAZEPRIL 20MG 100FCT BO V1 US
	[***]

	BENAZEPRIL 5MG 100FCT BO V1 US
	[***]

	BISOP FUM 10MG 30FCT BO US
	[***]

	CEFPROZIL 250MG 100FCT BO US
	[***]

	CILOSTAZOL 100MG USP 60TAB BO US
	[***]

	CILOSTAZOL 50MG USP 60TAB BO US
	[***]

	DICLOFENAC POT 50MG 100FCT BO US
	[***]

	DICLOFENAC SOD 25MG 100GRT BO US
	[***]

	DICLOFENAC SOD 75MG 100GRT BO US
	[***]

	DICLOFENAC SOD 75MG 60GRT BO US
	[***]

	ECONAZOLE NITRATE 1% 15G CRM US
	[***]

	LISINOPRIL 10MG 100TAB BO V4 US
	[***]

	LISINOPRIL 2.5MG 1000TAB BO V2 US
	[***]

	LISINOPRIL 20MG 100TAB BO V4 US
	[***]

	LISINOPRIL 30MG 100TAB BO V3 US
	[***]

	LISINOPRIL 40MG 100TAB BO V3 US
	[***]

	LISINOPRIL 5MG 100TAB BO V3 US
	[***]

	LISINOPRIL BPP 10MG 100TAB BO V1 US
	[***]

	LISINOPRIL BPP 20MG 1000TAB BO V1 US
	[***]

	LISINOPRIL BPP 30MG 100TAB BO V1 US
	[***]

	LISINOPRIL BPP 40MG 1000TAB BO V1 US
	[***]

	METHIMAZOLE 10MG 1000TAB BO US
	[***]

	METHIMAZOLE 5MG 100TAB BO US
	[***]

	MIDODRINE USP 10MG 100TAB BO US
	[***]

	MIDODRINE USP 5MG 100TAB BO US
	[***]

	NABUMETONE 500MG 100FCT BO US
	[***]

	NABUMETONE 750MG 100FCT BO US
	[***]

	ONDANSETRON HCL 4MG 30FCT BO US
	[***]

	ONDANSETRON HCL 8MG 30FCT BO V1 US
	[***]

	REPAGLINIDE 2MG 100TAB BO US
	[***]

	SPIRONOLACTONE 25MG 1000FCT BO US
	[***]

	TIZANIDINE USP 2MG 1000TAB BO US
	[***]

	TIZANIDINE USP 4MG 300TAB BO US
	[***]

​
​

​

​

Schedule 1.50
​
Seller’s Knowledge
​
[***]
[***]
[***]
​
​

​

​

Schedule 6.2.2.2
​
Settled, Dismissed, Pending or Threatened ANDA Infringement Claims
​
Aripiprazole (ANDA 78-611)
​
​
		●	3:07-cv-01000-MLC-LHG Otsuka Pharmaceutical Co., Ltd. v. Sandoz, Inc. (D.N.J.)

​
		●	1:15-cv-01716-JBS-KMW Otsuka Pharmaceutical Co., Ltd. v. Sandoz, Inc. (D.N.J.)

​
Bepotastine (1.5%) (ANDA 206080)
​
		●	3:14-cv-01325-MAS-DEA Bausch & Lomb Inc. et al. v. Sandoz Inc. and Sandoz Int’l GMBH (D.N.J.)

​
Desvenlafaxine (ANDA 204028)
​
		●	1:2012-cv-00814 (D.Del.) Pfizer Inc. et al. v. Sandoz Inc.

​
		●	3:2012-cv-03880 (D.N.J.) Pfizer Inc. et al. v. Sandoz Inc.

​
Ondansetron (ANDA 77-517)
​
		●	2:05-cv-02497-JCL-MF Glaxo Group Ltd et al. v. Sandoz Inc. (D.N.J.)(filed 5/9/05)

​
Repaglinide (ANDA 78-555)
​
		●	3:11-cv-06106-FLW Novo Nordisk Inc. et al. v. Sandoz Inc. (D.N.J.)

		●	2:2011-cv-13594 Sandoz Inc. v. Novo Nordisk Inc. et al. (E.D.Mich.)

​
Ribavirin (ANDA 76-192)
​
		●	2:02-cv-03544-MRP-FMO ICN Pharmaceutical, Inc. et al. v. Geneva Pharmaceuticals Technology Corp., et al. (C.D.Cal.)

		●	2:02-cv-03543 ICN Pharmaceutical, Inc. et al. v. Geneva Pharmaceuticals Technology Corp., et al. (C.D.Cal.)

		●	Court of Appeals Federal Circuit (cafc) 04-1047

		●	2:01-cv-04556-DMC Schering Corp. v. Geneva Pharmaceuticals Technology Corp. (D.N.J.)

		●	2:02-cv-01564-DMC Schering Corp. v. Geneva Pharmaceuticals Technology Corp. (D.N.J.)

​
​

​

​

Schedule 6.2.3.1
​
Pending Legal Proceedings
​
Benazepril HCTZ tablets (10-12.5mg, 20-12.5mg, 20-25mg) are subject of the civil antitrust price fixing cases consolidated under In re Generic Pharmaceuticals Pricing Antitrust Litigation, MDL No. 2724, No. 16-MD-2724-CMR (E.D. Pa.) (Hon. Cynthia M. Rufe).  The cases are:
​
		●	In re Benazepril Actions (Direct Purchasers), 16-BZ-27241

		●	In re Benazepril Actions (End Payor Purchasers), 16-BZ-27242

		●	In re Benazepril Actions (Indirect Reseller Purchasers), 16-BZ-27243

​
Ondansetron is currently subject of industry-wide products liability litigation.  Approximately 376 cases have been consolidated in a multi-district litigation (“MDL”) under In re: Zofran (Ondansetron) Products Liability, MDL 2657 (D. Mass.) (Hon. F. Dennis Saylor).  In addition, there are approximately 15 cases pending in state courts.  Cases in which Sandoz Inc. was, is, or may be implicated are:
​
		●	Valerie Maenza, et al. v. Sandoz Inc. and GlaxoSmithKline, LLC, No. 1:15-cv-13947-FDS (D. Mass.)

		●	Heather Perham, individually and on behalf of her minor child, X.M. v. GlaxoSmithKline, LLC, Sandoz, Inc., Sun Pharmaceuticals Industries, Ltd., No. 1:16-cv-10199-FDS (D. Mass.)

		●	Dawn M. Ramsey and Byron Rossberg v. GlaxoSmithKline, LLC., No. 1:16-cv-11980-FDS (D. Mass.)

		●	Jennifer London, individually and on behalf of and as representative for M.L. a deceased minor, and Charles London, individually v. GlaxoSmithKline and Sandoz Inc., No. 1:16-cv-12051-FDS (D. Mass.)

​
Schedule 6.2.3.2
​
Prior Legal Proceedings
​
Econazole Nitrate topical cream is subject of the civil antitrust price fixing cases consolidated under In re Generic Pharmaceuticals Pricing Antitrust Litigation, MDL No. 2724, No. 16-MD-2724-CMR (E.D. Pa.) (Hon. Cynthia M. Rufe).  The cases are:
​
		●	In re Econazole Cases (Lead Case), 16-EC-27240

		●	In re Econazole Cases (Direct Purchasers), 16-EC-27241

		●	In re Econazole Cases (End Payors), 16-EC-27242

		●	In re Econazole Cases (Indirect Reseller Purchasers), 16-EC-27243

​
​

​

​

Schedule 6.2.5
​
Recalls
​
	Product Name
	Lot Number
	Recall Initiation Date
	Status
	Date of Recall Closure
	Recall Class
	Recall Level
	Issue

	[***]
	[***]
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	[***]
	[***]

​

​

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