LICENSE AGREEMENT by and between ANJI PHARMACEUTICALS INC. and LIPIMETIX DEVELOPMENT, INC. MAY 2, 2018 LICENSE AGREEMENT
Exhibit 10.1
by and between
ANJI PHARMACEUTICALS INC.
and
LIPIMETIX DEVELOPMENT, INC.
MAY 2, 2018
This License Agreement (the “Agreement”) is entered into as of May 2, 2018 (the “Effective Date”), by and between Anji Pharmaceuticals Inc., a company organized and existing under the laws of the Cayman Islands and having an address at X.X. Xxx 00000 Xxxxx Xxxxxxxx, Xxxxxxxx Way, 802 West Bay Road, Grand Cayman, KY1 – 1205, Cayman Islands (“Anji Pharma”) and LipimetiX Development, Inc. a corporation organized and existing under the laws of Delaware and having an address at 0 Xxxxxxxxxxxx Xxxx, Xxxxx 0x, Xxxxxx, XX 00000 (“LipimetiX”). Anji Pharma and LipimetiX may each be referred to herein individually as a “Party” and collectively as the “Parties.”
| 1. | DEFINITIONS AND INTERPRETATION. |
1.1. “Affiliate” means, as of any point in time and for so long as such relationship continues to exist with respect to any Person, any other Person that controls, is controlled by, or is under common control with, such Person. A Person shall be regarded as in control of another Person if it (a) owns or controls more than fifty (50%) of the equity securities of the subject Person entitled to vote in the election of directors or (b) possesses, directly or indirectly, the power to direct or cause the direction of the management or policies of any such Person (whether through ownership of securities or other ownership interests, by contract or otherwise).
1.2. “Anji Pharma IP” means the Anji Pharma Patent Rights and Anji Pharma Technology.
1.3. “Anji Pharma Patent Rights” means any Patent Rights that Cover the composition of matter or use of the Compound or Product (but not to any other component of a Combination Product) as contemplated by this Agreement, or that Cover any processes used for manufacturing the Compound or Product (but not to any other component of a Combination Product) under this Agreement, and that are Controlled by Anji Pharma or any of its Affiliates as of the Effective Date or that comes into the Control of Anji Pharma or any of its Affiliates during the Term (other than through the grant of a license by LipimetiX or any of its Affiliates), but excluding Product Patent Rights.
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1.4. “Anji Pharma Related Party” means Anji Pharma, an Affiliate of Anji Pharma or any permitted Sublicensee of Anji Pharma.
1.5. “Anji Pharma Technology” means any Technology related to the composition of matter or use of the Compound or Product (but not to any other component of a Combination Product) as contemplated by this Agreement, or processes used for manufacturing the Compound or Product (but not to any other component of a Combination Product) under this Agreement that are Controlled by Anji Pharma or any of its Affiliates as of the Effective Date or that come into the Control of Anji Pharma or any of its Affiliates during the Term (other than through the grant of a license by LipimetiX or any of its Affiliates), but excluding Product Technology and Technology claimed or disclosed in Product Patent Rights or Anji Pharma Patent Rights.
1.6. “Applicable Law” means the laws, statutes, rules, regulations, guidelines, or other requirements that may be in effect from time to time and apply to a Party’s activities to be performed under this Agreement, including any such laws, statutes, rules, regulations, guidelines or other requirements of the CFDA or China’s Ministry of Health.
1.7. “Business Day” means a day other than a Saturday, Sunday or bank or other public holiday in Boston, Massachusetts.
1.8. “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.
1.9. “CFDA” means China’s Food and Drug Administration and any successor agency or authority having substantially the same function.
1.10. “Change of Control” means, with respect to a Party, (a) a merger or consolidation of such Party with a Third Party that results in the voting securities of such Party outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent more than fifty percent (50%) of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger or consolidation, or (b) a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the beneficial owner of more than fifty percent (50%) of the combined voting power of the outstanding securities of such Party, or (c) the sale or other transfer to a Third Party of all or substantially all of such Party’s business or assets to which this Agreement relates, but in any event, excluding any consolidation or merger effected exclusively to change the domicile of a Party, any transaction or series of transactions effected principally for a bona fide financing transaction, or a stock sale to underwriters in a public offering. The acquiring or combining Third Party in any of (a), (b) or (c), and any of such Third Party’s Affiliates (other than the acquired Party and its Affiliates as in existence prior to the applicable transaction) are referred to collectively herein as the “Acquirer.”
1.11. “Combination Product” means a (a) Product that is comprised of or contains a Compound as an active ingredient together with one (1) or more other therapeutically active pharmaceutical ingredients and is sold either as a fixed dose or as separate doses as one (1) product or (b) a Product sold together under one sales price with one or more other finished products or devices. Combination Product shall include conjugates or complexes of the Compound with other therapeutically active ingredients (regardless of whether such conjugate or complex is also a modification of Apo E mimetic peptide incorporating the base peptide AEM-28).
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1.12. “Commercialize” or “Commercializing” means activities directed to obtaining pricing and reimbursement approvals and regulatory activities pertaining to same, and to market, promote, distribute, offer for sale, sell, have sold, import, have imported, export, have exported or otherwise commercialize a pharmaceutical compound or product. When used as a noun, “Commercialization” means any and all activities involved in Commercializing.
1.13. “Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party with respect to any objective, those reasonable, good faith efforts to accomplish such objective as a biotechnology company would normally use to accomplish a similar objective under similar circumstances. With respect to any efforts relating to the Development, the seeking or obtaining of Regulatory Approval or Commercialization of a Compound or Product by a Party, a Party will be deemed to have exercised Commercially Reasonable Efforts if such Party has exercised those efforts normally used by a biotechnology company, in the relevant jurisdiction, with respect to a compound or product of similar therapeutic modality, with similar market potential in such jurisdiction and at a similar stage in its Development or product life cycle, as the Compound or Product, in each case, taking into account all relevant factors that may affect the Development, Regulatory Approval, Manufacture or Commercialization of a pharmaceutical product, including (as applicable): actual and potential issues of safety, efficacy and/or stability; product profile (including product modality, category and mechanism of action); stage of Development or life cycle status; actual and projected Development, Regulatory Approval, Manufacturing and Commercialization costs; Manufacturing difficulties; the likelihood of obtaining Regulatory Approvals (including satisfactory reimbursement or pricing approvals); the timing of such approvals; the regulatory environment and the current and projected regulatory status; labeling or anticipated labeling; competitive landscape, existing or projected pricing, sales, reimbursement and profitability, proprietary position, strength and duration of patent protection and anticipated exclusivity, and other relevant scientific, legal and commercial factors.
1.14. “Compound” means the Apo E mimetic peptide incorporating the base peptide AEM-28 identified as of the Effective Date as AEM-28-14, and any salt, free acid/base, solvate, hydrate, stereoisomer and polymorphic form thereof, and any prodrug, derivative or modification thereof, but excluding any component of a derivative or modification that constitutes a pharmaceutically active ingredient or component which is not an Apo E mimetic peptide.
1.15. “Confidential Information” means, with respect to a Party, all confidential, non-public information, Technology and materials (whether or not patentable) and other non-public proprietary information that is communicated or provided by, or on behalf of, one Party or its Affiliates or any of their respective Representatives (the “Disclosing Party”) to the other Party or its Affiliates or any of their respective Representatives (the “Receiving Party”), whether orally or in written, electronic or other form or media, on or after the Effective Date or pursuant to that certain Mutual Confidentiality Agreement, by and between the Parties, dated as of January 26, 2018 (the “Non-Disclosure Agreement”) but only to the extent that such information (a) is marked in writing as “confidential” or with other similar designation to indicate its confidential nature at the time of disclosure, or (b) is disclosed orally or in non-tangible form and is indicated to be confidential at the time of disclosure or, within thirty (30) days after disclosure, the Disclosing Party provides a written summary of such information marked as “confidential” or with other similar designation to indicate its confidential nature; provided, however, that if a Person would reasonably determine any disclosed information to be confidential, such information shall be deemed Confidential Information whether or not such information was marked, designated, or otherwise identified as confidential. Confidential Information does not include any information, Technology or materials that can be established by the Receiving Party by competent proof that it (i) was already known by the Receiving Party without an obligation of confidentiality at the time of disclosure with respect to such information, (ii) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party, (iii) became generally available to the public or otherwise part of the public domain after its disclosure to the Receiving Party, other than through any act or omission of the Receiving Party in breach of its confidentiality obligations under this Agreement or the Non-Disclosure Agreement, (iv) was disclosed to the Receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation of confidentiality with respect to such information, or (v) was independently discovered or developed by, or on behalf of, the Receiving Party without reference to, or use of, in whole or in part, any Confidential Information belonging to the Disclosing Party.
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1.16. “Control” or “Controlled” means with respect to any item of information, material or intellectual property right (including any Patent Right or Technology) or other data, information or material, the ability (whether by sole, joint or other ownership interest, license or otherwise, other than pursuant to this Agreement) to, without violating the terms of any agreement with a Third Party, assign, grant a license or sublicense or provide access or other right in (as applicable based on the context), to or under such intellectual property right, data, information or material; provided, that neither Party shall be deemed to Control any item of information, material or intellectual property right (a) if access requires or triggers a payment obligation not reimbursed by the other Party requesting access, or (b) that was owned or controlled by an Acquirer of such Party (i) prior to a Change of Control of such Party or (ii) after a Change of Control of such Party that, in the case of (ii), was developed, invented or obtained by the Acquirer after the Change of Control without the use of any Confidential Information or proprietary materials of the Party undergoing such Change of Control that are related to this Agreement.
1.17. “Cover” means with respect to any Patent Right and the subject matter at issue that, but for an ownership right or license or sublicense granted under a Valid Claim of such Patent Right, the use, Development, Manufacture, Commercialization or practice of the subject matter at issue would infringe such Valid Claim of such Patent Right. “Covers,” “Covered” and “Covering” shall have correlative meanings.
1.18. “Development” means non-clinical and clinical drug research and development activities reasonably related to the development and submission of information to a Regulatory Authority, including toxicology, pharmacology and other discovery and pre-clinical efforts, test method development and stability testing, process development, formulation development, development manufacturing, delivery system development, quality assurance and quality control development, and clinical studies (including pre- and post-approval studies but specifically excluding regulatory activities directed to obtaining pricing and reimbursement approvals. When used as a verb, “Develop” means to engage in Development.
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1.19. “Development Plan” means the Initial Development Plan, and any updates to such Initial Development Plan (or any subsequent version thereof) by an Anji Pharma Related Party in accordance with Section 4.1, which plan sets forth the non-clinical and clinical Development activities with respect to the Product.
1.20. “Field” means all diagnostic, therapeutic and prophylactic uses for all indications, except for the diseases of the eye, with respect to LipimetiX IP licensed from UABRF under the UABRF Agreement.
1.21. “First Commercial Sale” means, with respect to any Product and with respect to any jurisdiction of the Territory, the first sale of such Product by an Anji Pharma Related Party to a Third Party, in such jurisdiction after such Product has been granted Regulatory Approval by the appropriate Regulatory Authority(ies) allowing an Anji Pharma Related Party to market and sell or have sold such Product in such jurisdiction.
1.22. “Generic Product” means any pharmaceutical product that (a) is sold by a Third Party that is not an Affiliate or Sublicensee of Anji Pharma under a marketing authorization granted by a Regulatory Authority to a Third Party, (b) contains the same active pharmaceutical ingredient as a Product and (c) is approved in reliance on a prior Regulatory Approval of a Product granted to an Anji Pharma Related Party by the applicable Regulatory Authority.
1.23. “Governmental Authority” means any court, arbitrator, agency, department, authority or other instrumentality of any national, state, county, city or other political subdivision, whether local or foreign.
1.24. “ICH” means the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
1.25. “IFRS” means the body of pronouncements issued from time to time by the International Accounting Standards Board or any successor thereto, including the International Financial Reporting Standards and Interpretations approved by the International Accounting Standards Board, consistently applied by the applicable Person.
1.26. “Indication” means an individual, separate and distinct disease or clinical condition. The Parties agree that (a) prevention of a disease or medical condition shall not be a separate indication from treatment of the same disease or medical condition; (b) the treatment or prevention of the same disease or medical condition in a different population shall not be a separate indication and (c) a label enhancement or elaboration or expansion of an approved Indication shall not be a separate indication even if one or more studies are performed to receive such enhancement or elaboration.
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1.27. “Invention” means any process, method, composition of matter, article of manufacture, discovery or finding, patentable or not patentable, which results (a) from the activities conducted pursuant to this Agreement by, or on behalf of, either or both the Anji Pharma Related Parties and/or LipimetiX and its Affiliates, or (b) from the use by one Party of the other Party’s Confidential Information disclosed under this Agreement.
1.28. “LipimetiX IP” means the LipimetiX Patent Rights and LipimetiX Technology.
1.29. “LipimetiX Patent Rights” means (a) the Patent Rights listed on Exhibit A, and (b) any other Patent Rights that Cover the composition of matter or use of the Compound or Product, or that Cover any processes for manufacturing the Compound or Product, and that are Controlled by LipimetiX or any of its Affiliates as of the Effective Date or come into the Control of LipimetiX or any of its Affiliates during the Term (other than through the grant of a license by Anji Pharma or any of its Affiliates), but excluding Product Patent Rights.
1.30. “LipimetiX Technology” means any Technology related to the composition of matter or use of the Compound or Product as contemplated by this Agreement, or processes used for manufacturing the Compound or Product under this Agreement that are Controlled by LipimetiX or any of its Affiliates as of the Effective Date or that comes into the Control of LipimetiX or any of its Affiliates during the Term (other than through the grant of a license by Anji Pharma or any of its Affiliates), but excluding Product Technology and any Technology claimed or disclosed in Product Patent Rights or LipimetiX Patent Rights.
1.31. “LipimetiX Third Party Agreement” means any agreement between LipimetiX (or any of its Affiliates) and any Third Party that relates to any of the LipimetiX IP, including without limitation the UABRF Agreement, attached hereto as Exhibit C.
1.32. “Manufacture” or “Manufacturing” means to make, produce, manufacture, process, fill, finish, package, label, perform quality assurance testing, release, ship or store a compound or product or any component thereof. When used as a noun, “Manufacture” or “Manufacturing” means any and all activities involved in Manufacturing a compound or product or any component thereof.
1.33. “Net Sales” means, with respect to a Product for any period, the total amount billed or invoiced on sales of such Product during such period by an Anji Pharma Related Party in the Territory to Third Parties (including wholesalers and distributors, but as the term Third Party or Third Parties is used in this definition of Net Sales, excluding permitted Sublicensees), in bona fide arm’s length transactions, less the following deductions, in each case, to the extent related specifically to the Product and incurred, allowed or taken by such Third Parties (to the extent not reimbursed by any Third Party):
1.33.1. trade, cash and quantity discounts;
1.33.2. price reductions or rebates, retroactive or otherwise, imposed by, negotiated with, or otherwise paid to, Governmental Authorities or other payors;
1.33.3. taxes on sales (such as sales, value added or use taxes), duties, customs, tariffs and other governmental charges or fees (to the extent not paid by the Third Party);
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1.33.4. amounts repaid or credited by reason of rejections, defects, returned goods allowances, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs;
1.33.5. any invoiced amounts from a prior period which are not collected, including bad debts, and are written off by Anji Pharma or its Affiliates or Sublicensees, provided that in the event such amounts are subsequently collected, such amounts shall be included in Net Sales;
1.33.6. freight, insurance, import/export and other transportation charges set forth separately as such in the total amount invoiced, as well as any fees for services provided by wholesalers and warehousing chains related to the distribution of such Products; and
1.33.7. any other similar and customary deductions that are consistent with IFRS.
In no event shall any particular deduction identified above be deducted more than once in calculating the Net Sales of a Product. Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory or governmental purposes (including on account of a compulsory license) for which an Anji Pharma Related Party receives de minimis amounts for good faith business purposes not exceeding the cost of such goods transferred or disposed. Net Sales shall not include sales between Anji Pharma Related Parties unless the transferee is the end purchaser, user or consumer of such Product. Subject to the above, Net Sales shall be calculated in accordance with the standard IFRS accounting procedures, as consistently applied by the applicable Anji Pharma Related Party. If an Anji Pharma Related Party receives consideration other than or in addition to cash upon the sale or disposition of a unit of Product to a Third Party, such as a barter transaction, Net Sales shall be calculated based on the fair market value of the non-cash consideration received for such unit of Product or the fair market value of the Product, based on the assessment by the applicable Anji Pharma Related Party using, as applicable, IFRS.
If an Anji Pharma Related Party separately sells in such jurisdiction, a product containing as its sole active ingredient a Compound contained in such Combination Product (the “Standalone Product”) and a product containing only the other components of a Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B) where “A” is the applicable Anji Pharma Related Party’s average Net Sales price during the period to which the Net Sales calculation applies for the Standalone Product in such jurisdiction and “B” is the applicable Anji Pharma Related Party’s average Net Sales price during the period to which the Net Sales calculation applies in such jurisdiction, for products that contain only the other components in such Combination Product.
If an Anji Pharma Related Party separately sells in such jurisdiction the Standalone Product but does not separately sell in such jurisdiction products containing only the other components of a Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction A/C where “A” is the applicable Anji Pharma Related Party’s average Net Sales price during the period to which the Net Sales calculation applies for the Standalone Product in such jurisdiction, and “C” is the applicable Anji Pharma Related Party’s average Net Sales price in such jurisdiction during the period to which the Net Sales calculation applies for such Combination Product.
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If an Anji Pharma Related Party does not separately sell in such jurisdiction both the Standalone Product and the other components in the Combination Product in the Territory, then the Parties shall discuss in good faith a method to appropriately attribute value to the Product within the Combination Product.
1.34. “Patent Rights” means (a) patents and patent applications, (b) all provisionals, divisionals, additions, substitutions, continuations, continuations-in-part or any other form of government-issued right substantially similar to any of the foregoing and (c) all patents issuing on any of the foregoing (including inventor’s certificates thereto) in (a) through (b), (d) all foreign counterparts of any of the foregoing in (a) through (c), including PCT applications, and (e) all registrations, reissues, re-examinations, supplemental protection certificates, renewals, restorations or extensions of any of the foregoing in (a) through (d).
1.35. “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision or department or agency of a government.
1.36. “Phase III Clinical Trial” means an adequate and well-controlled human clinical study conducted on sufficient numbers of human subjects and appropriately designed for the indication to serve as a pivotal study to support Regulatory Approval, and ultimately provide sufficient evidence for the review of drug registration application for marketing approval by the CFDA or as otherwise may be defined in SFDA Order No. 28.
1.37. “Product” means the pharmaceutical product containing the Compound in all forms, presentations, formulations and dosage forms.
1.38. “Product Inventions” means any Invention that (i) is specific to the Compound or (ii) to the extent such Invention is Controlled by Anji Pharma or its Affiliates or LipimetiX or its Affiliates, or both, as may be applicable, is specific to the Product as it relates to the Compound.
1.39. “Product IP” means the Product Patent Rights and Product Technology.
1.40. “Product Patent Rights” means any Patent Right claiming Product Inventions.
1.41. “Product Technology” means any Technology that results (a) from the activities conducted pursuant to this Agreement by, or on behalf of, either or both the Anji Pharma Related Parties and/or LipimetiX and its Affiliates, or (b) from the use by one Party of the other Party’s Confidential Information disclosed under this Agreement, in each case of (a) and (b), that (i) is specific to the Compound or (ii) to the extent such Technology is Controlled by Anji Pharma or its Affiliates or LipimetiX or its Affiliates, or both, as may be applicable, to the Product as it specifically relates to the Compound, and in all cases excluding Technology claimed in Product Patent Rights.
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1.42. “Regulatory Approval” means all technical, medical and scientific licenses, registrations, authorizations and approvals (including drug registration approvals, supplements and amendments, marketing approvals, pricing and third party reimbursement approvals (but only to the extent such pricing and third party reimbursement approvals are required to sell the Product), and labeling approvals) of any applicable Regulatory Authority, necessary for the use, Development, Manufacture and Commercialization of a pharmaceutical product in a regulatory jurisdiction.
1.43. “Regulatory Authority” means, with respect to a jurisdiction in the Territory, any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other Governmental Authority involved in the granting of a Regulatory Approval or, to the extent required in such jurisdiction, price approval, for pharmaceutical products in such jurisdiction.
1.44. “Regulatory Exclusivities” means, with respect to any jurisdiction in the Territory, the additional market protections, other than Patent Right protection, granted or recognized by a Regulatory Authority in such jurisdiction that confers an exclusive Commercialization period during which an Anji Pharma Related Party has the exclusive right to market and sell a Compound or Product in such jurisdiction through a regulatory exclusivity right (e.g., new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity or any applicable data exclusivity).
1.45. “Representatives” means (a) with respect to Anji Pharma, the Anji Pharma Related Parties and each of their respective officers, directors, employees, consultants, contractors and agents and (b) with respect to LipimetiX, LipimetiX, its Affiliates and each of their respective officers, directors, employees, consultants, contractors and agents.
1.46. “Residual Knowledge” means knowledge, techniques, experience and Technology that (a) are, or are based on, any Confidential Information Controlled by the Disclosing Party and (b) are retained in the unaided memory of any authorized Representative of the Receiving Party after having access to such Confidential Information. An individual’s memory will be considered to be unaided if the individual has not intentionally memorized the Confidential Information for the purpose of retaining and subsequently using or disclosing it. In no event, however, will Residual Knowledge include any knowledge, techniques, experience and Technology to the extent (at any time, for such time) within the scope of any issued patent claim Controlled by the Disclosing Party.
1.47. “Royalty Term” means, with respect to any particular Product in any particular jurisdiction in the Territory, the period of time beginning on the First Commercial Sale of such Product in such jurisdiction and ending on the later of (a) the expiration of the last to expire Valid Claim of the (i) LipimetiX Patent Rights, (ii) Product Patent Rights or (iii) any other Patent Right claiming an Invention specific to the Compound or the Product as it relates to the Compound, in the case of each of (i), (ii) and (iii), such Patent Rights containing a Valid Claim that Covers the sale of Product in the People’s Republic of China, (b) ten (10) years from the First Commercial Sale of the first Product in such jurisdiction, and (c) expiration of all Regulatory Exclusivities in such jurisdiction.
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1.48. “Sublicensee” means any Person to whom Anji Pharma or any of its Affiliate grants or has granted directly a sublicense of rights licensed by LipimetiX to Anji Pharma or its Affiliates under this Agreement.
1.49. “Technology” means any proprietary development, invention, improvement, method, technique, conception, know-how, data (including pre-clinical and clinical data), results, material, specification, discovery, process, technology, cell line, Compound, probe, sequence or other information, whether or not patentable, and any physical embodiment of any of the foregoing.
1.50. “Territory” means the People’s Republic of China, Hong Kong and Taiwan.
1.51. “Third Party” means any Person other than Anji Pharma, LipimetiX or their respective Affiliates.
1.52. “Trademark” means any trademark, trade name, service xxxx, service name, brand, domain name, trade dress, logo, slogan or other indicia of origin or ownership, including the goodwill and activities associated with each of the foregoing.
1.53. “UABRF Agreement” means that certain Exclusive License Agreement, by and between LipimetiX and the UAB Research Foundation (“UABRF”), dated as of August 26, 2011, as amended by that certain First Amendment and Consent to Assignment of Exclusive License Agreement on August 3, 2012, and by that certain Second Amendment to Exclusive License Agreement on December 15, 2014, as may be further amended or restated from time to time, copies of which are attached hereto as Exhibit C.
1.54. “Valid Claim” means (a) a pending patent claim included within a pending patent application that has not (i) expired, been withdrawn from consideration or been finally abandoned or rejected, or (ii) been pending for more than seven (7) years after the effective date of filing of the patent application in which such pending patent claim is included; and (b) an issued and unexpired patent claim included within an issued and unexpired patent that has not been revoked, held unenforceable, unallowable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, to which an appeal has not or cannot be taken within the time allowed for appeal, and that has not been disclaimed, denied, or admitted to be invalid or unenforceable through reissue, re-examination, inter partes review, post-grant review, disclaimer, nullity, suit or otherwise.
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| Defined Term | Location in Agreement |
| Acquirer | 1.10 |
| Additional Anji Pharma IP | 2.6.2 |
| Additional LipimetiX IP | 2.6.1 |
| Additional Third Party License | 3.3.2.1 |
| Agreement | Preamble |
| Amount | 3.5.2 |
| Anji Pharma | Preamble |
| Anji Pharma Indemnitees | 10.2 |
| Bankruptcy Code | 9.8 |
| Breaching Party | 9.3 |
| Claims | 10.1 |
| Default Notice | 9.3 |
| Diligence Issue | 11.9.1 |
| Disclosing Party | 1.15 |
| Effective Date | Preamble |
| Executive Officers | 11.9.3 |
| ICC | 11.11 |
| IMS | 3.3.2.3 |
| Infringement Claim | 6.3.5 |
| Initial Development Plan | 4.1 |
| Licensed Activities | 6.3.4.1 |
| LipimetiX | Preamble |
| LipimetiX Indemnitees | 10.1 |
| LipimetiX Minimum Royalty Payments | 3.3.4.1 |
| Losses | 10.1 |
| Non-Breaching Party | 9.3 |
| Non-Disclosure Agreement | 1.15 |
| Notice of Dispute | 11.9.2 |
| Party and Parties | Preamble |
| Receiving Party | 1.15 |
| Review Period | 7.5.2 |
| Shortfall Payments | 3.3.4.2 |
| Standalone Product | 1.33 |
| Term | 9.1 |
| Third Party IP Rights | 6.3.4.1 |
| UABRF | 1.53 |
| UABRF Minimum Royalty Payments | 3.3.4 |
| Withholding Party | 3.5.2 |
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2. LICENSE GRANTS AND TECHNOLOGY TRANSFER.
| 2.1. | Grants to Anji Pharma. |
| 2.2. | Grants to LipimetiX. |
2.2.2. Product IP License in the Territory During the Term. Anji Pharma hereby grants to LipimetiX and its Affiliates during the Term a royalty-free, fully paid-up, fully sublicensable through multiple tiers, non-exclusive license under Anji Pharma’s rights in the Product IP for LipimetiX’s non-clinical Development of Compounds and Products in the Territory solely for purposes of using, having used, Developing, having Developed, Manufacturing, having Manufactured, Commercializing, having Commercialized or otherwise exploiting Compounds and Products outside of the Territory.
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2.3. Right to Sublicense. Either Party shall have the right to grant sublicenses to its Affiliates and Third Parties of the licenses granted to such Party under Section 2.1.1, 2.2.1 or 2.2.2, provided, that such Party provides the other Party with a copy of each sublicense agreement, which may be appropriately redacted, provided that such Party discloses to the other Party the terms relevant to determine compliance with this Agreement. Any such sublicense shall be consistent with, and subordinate to, the terms and conditions contained herein, and with respect to sublicenses granted by any Anji Pharma Related Parties, further be subject to, consistent with, and subordinate to, the terms and conditions of the UABRF Agreement.
2.6. Continuing Disclosure and Knowledge Transfer; Inclusion of Additional Intellectual Property.
2.6.1. During the Term, on a Calendar Quarter basis, or more frequently at the reasonable request of Anji Pharma but not to exceed once per month, subject to any Third Party confidentiality obligations, LipimetiX will confidentially disclose to Anji Pharma (or if requested by Anji Pharma, an Anji Pharma Related Party or subcontractor of Anji Pharma) all Technology or Patent Rights that are developed by, or on behalf of, LipimetiX or that otherwise come into the Control of LipimetiX and (a) that are necessary to the Development, Manufacture or Commercialization of the Compound or Product in the Field in the Territory, or (b) that LipimetiX is currently using to Develop, Manufacture or Commercialize the Product or any other Apo E mimetic peptide product outside the Territory (the “Additional LipimetiX IP”). In the event and to the extent such Additional LipimetiX IP is Controlled by LipimetiX or its Affiliates, following good faith discussions by the Parties, Anji Pharma determines that such Additional LipimetiX IP will be included in the LipimetiX IP, Anji Pharma shall confirm such inclusion in writing and if and to the extent necessary under the terms of any Third Party agreement under which such Additional LipimetiX IP is licensed to Anji Pharma, the Parties shall amend this Agreement to incorporate any new terms required by such inclusion, and such Patent Rights shall thereafter become a LipimetiX Patent Right and such Technology shall become LipimetiX Technology upon receipt of such written notice confirming the same or, as applicable, such amendment of the Agreement.
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2.6.2. During the Term, on a Calendar Quarter basis, or more frequently at the reasonable request of LipimetiX but not to exceed once per month, subject to any Third Party confidentiality obligations, Anji Pharma will confidentially disclose to LipimetiX (or if requested by LipimetiX, an Affiliate of LipimetiX or subcontractor of LipimetiX) all Technology or Patent Rights that are developed by, or on behalf of Anji Pharma or that otherwise come into the Control of Anji Pharma or an Anji Pharma Related Party and (a) that are necessary to the Development, Manufacture or Commercialization of the Compound or Product in the Field outside the Territory, or (b) that Anji Pharma is currently using to Develop, Manufacture or Commercialize the Product or any other Apo E mimetic peptide product in the Field inside the Territory (the “Additional Anji Pharma IP”). In the event, following good faith discussions by the Parties, LipimetiX determines that such Additional Anji Pharma IP is of interest to LipimetiX for use with the Compound or Product outside the Territory, then, to the extent such Additional Anji Pharma IP is Controlled by Anji Pharma or its Affiliates, LipimetiX shall have the right to obtain from Anji Pharma a sole and exclusive (even as to Anji Pharma and its Affiliates) royalty-bearing license, with the right to sublicense, under the Additional Anji Pharma IP Controlled by Anji Pharma, to use, have used, Develop, have Developed, Manufacture, have Manufactured, Commercialize and have Commercialized Compounds and Products in the Field outside the Territory on terms and conditions that are commercially reasonable and substantially similar to those set forth in this Agreement with respect to the Development, Manufacture and Commercialization of Compounds and Products by Anji Pharma in the Territory.
2.6.3. During the Term, LipimetiX will make appropriately qualified, experienced and trained personnel available to Anji Pharma at reasonable times and places and upon reasonable prior written notice for the purpose of assisting Anji Pharma to understand and use the LipimetiX IP in connection with Anji Pharma’s Development, Manufacture, Commercialization and use of the Compounds and Products in the Field in the Territory; provided, however, that:
2.6.3.1. all such access to such personnel shall be conducted in a manner that is reasonably acceptable to each of the Parties;
2.6.3.2. LipimetiX makes no warranty, express or implied, that the Anji Related Parties shall be able to successfully implement and use the LipimetiX Technology, regardless of such access to such personnel;
2.6.3.3. LipimetiX shall not be in default hereunder for any inadvertent failure to disclose all pertinent information related to the LipimetiX Technology, provided, that LipimetiX used good faith efforts to provide all pertinent information and that such information shall be supplied to Anji Pharma promptly upon discovery of such failure to disclose or upon request of Anji Pharma identifying with reasonable specificity the nature of the information to be disclosed; and
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2.6.3.4. Anji Pharma shall be responsible for ensuring that Anji Pharma Related Parties’ personnel who receive such assistance are appropriately qualified, experienced and trained for such purpose.
2.7. Exclusivity. Except to the extent set forth in the Development Plan, during the Term:
2.7.1. LipimetiX shall not, and shall cause its Affiliates not to, (a) directly or indirectly, research, Develop, Manufacture, Commercialize or otherwise exploit the Compound or Product in the Territory, or (b) license, authorize, appoint or otherwise enable any Third Party to directly or indirectly, research, Develop, Manufacture, Commercialize or otherwise exploit the Compound or Product in the Territory; and
2.7.2. Anji Pharma shall not, and shall cause its Affiliates and Sublicensees not to, (a) directly or indirectly, research, Develop, Manufacture, Commercialize or otherwise exploit the Compound or Product outside of the Territory, or (b) license, authorize, appoint or otherwise enable any Third Party to directly or indirectly, research, Develop, Manufacture, Commercialize or otherwise exploit the Compound or Product outside of the Territory.
| 3. | PAYMENTS. |
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3.3.4.1. In the event that either (a) LipimetiX (or its Affiliates or Sublicensees) has a First Commercial Sale for any Product sold outside the Field or outside the Territory prior to an Anji Pharma Related Party having a First Commercial Sale for the relevant Product, or (b) the aggregate royalty payments due to LipimetiX under Sections 3.3.1 and 3.3.2 meet or exceed the applicable minimum royalty payment as set forth in the table below (“LipimetiX Minimum Royalty Payments”) for Net Sales occurring before the date set forth in the table below, then in the case of each of (a) and (b) LipimetiX shall be fully responsible and liable for paying the applicable UABRF Minimum Royalty Payments to UABRF.
3.3.4.2. In the event that (a) an Anji Pharma Related Party has a First Commercial Sale for any Product inside the Field and inside the Territory prior to LipimetiX having a First Commercial Sale for the relevant Product outside the Field or outside the Territory and (b) the aggregate royalty payments due to LipimetiX under Sections 3.3.1 and 3.3.2 are less than the applicable LipimetiX Minimum Royalty Payment for Net Sales occurring before the date set forth below, then, for each calendar year ending prior to the time that LipimetiX or any of its Affiliates or licensees (other than an Anji Pharma Related Party) sells any product covered by the UABRF Agreement, Anji Pharma shall pay to LipimetiX the amount of the difference between the applicable LipimetiX Minimum Royalty Payment and the aggregate royalty payments due under Sections 3.3.1 and 3.3.2 (the “Shortfall Payments”) concurrently with, and in addition to, the payment of such aggregate royalty amounts due under Sections 3.3.1 and 3.3.2 for the Calendar Quarter ending on December 31 of the applicable calendar year, and LipimetiX shall in turn pay UABRF the UABRF Minimum Royalty Payment due. Beginning on the calendar year in which LipimetiX or any of its Affiliates or licensees (other than an Anji Pharma Related Party) sells any product covered by the UABRF Agreement, LipimetiX shall be fully responsible for payment of the UABRF Minimum Royalty Payment and Anji Pharma shall have no further obligation to pay any Shortfall Payment. Each Shortfall Payment made by Anji Pharma to LipimetiX hereunder shall carry forward and be credited against any royalties otherwise payable to LipimetiX in subsequent Calendar Quarters.
| Calendar Year Ending | Minimum Royalty Payment |
| December 31 of the first calendar year following the calendar year in which the First Commercial Sale occurs | Five hundred thousand dollars (US $500,000) |
| Each December 31 thereafter during the Term | One million dollars (US $1,000,000) |
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Upon the expiration of the Term or earlier termination of this Agreement, any minimum royalties shall be pro-rated as of the date of termination or expiration by the number of days elapsed in the applicable twelve (12) month period. In the event of “generic competition, the sale of any combination products and/or the grant of compulsory licenses,” as contemplated under Section 5.9 of the UABRF Agreement, LipimetiX shall negotiate in good faith amendments to the UABRF Minimum Royalty Payments, as permitted by Section 5.9 of the UABRF Agreement. LipimetiX agrees that any benefits or reductions received by LipimetiX under the UABRF Agreement with respect to the minimum royalty payments shall flow through to this Agreement and the Parties shall amend this Agreement to make corresponding adjustments. In no event shall Anji Pharma be obligated to pay any minimum royalty payment in excess of the amounts set forth in this Agreement, regardless of any amendment to the UABRF Agreement.
3.4. Fully Paid-Up, Royalty Free License. Following expiration of the Royalty Term for any Product in a given jurisdiction, no further royalties shall be payable in respect of sales of such Product in such jurisdiction and, thereafter the license granted to Anji Pharma under Section 2.1.1 shall automatically become fully paid-up, perpetual, irrevocable and royalty-free.
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| Financial Institution: | Xxxxx Fargo Bank, N.A. | |
| 000 Xxxxxxxxxx Xxxxxx | ||
| Xxx Xxxxxxxxx, XX 00000 |
ABA Routing Number: 000000000
Account Number: 4122326481
Account Name: LipimetiX Development, Inc.
Amount of Transfer/Currency: $
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3.11. Audits. At the request of LipimetiX, Anji Pharma shall permit an independent public accounting firm of nationally recognized standing selected by LipimetiX and as to which Anji Pharma has no reasonable objection, at reasonable times during normal business hours and upon reasonable notice, to audit the books and accounts of Anji Pharma or its Affiliates, as well as all necessary supporting records maintained by Anji Pharma or its Affiliates pursuant to Section 3.10 to ensure the accuracy of all reports and payments made hereunder. Such audits may not (a) be conducted for any Calendar Quarter more than three (3) years after the end of such Calendar Quarter, (b) be conducted more than once in any given twelve (12) month period or (c) be repeated for any Calendar Quarter, except in the case of fraud or willful misconduct. Anji Pharma shall include similar audit rights in its sublicense agreements with any applicable Sublicensee. The accounting firm shall disclose only whether the reports are correct or not, and the specific details concerning any discrepancies (including the reasons therefor). No other information shall be shared. The results of each audit, if any, shall be binding on both Parties absent manifest error in respect to such audit. Except as provided below, the cost of each audit shall be borne by LipimetiX, unless the audit reveals a variance of more than the greater of five percent (5%) from the reported amounts, in which case Anji Pharma shall bear the reasonable out-of-pocket costs of the audit.
4. PRODUCT DEVELOPMENT AND REGULATORY AFFAIRS.
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Development plan within thirty (30) days thereafter, which upon mutual acceptance by the Parties, shall be deemed effective (the “Initial Development Plan”). During the Term, except as may be expressly set forth in this Agreement and the Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have sole authority over, and control of, the Development of Compounds and Products in the Territory, including the Manufacture of Compounds and Products for such Development, and shall bear all costs and expenses of such Development. Prior to January 1 of each calendar year during the Term, an Anji Pharma Related Party shall prepare an updated Development Plan for the following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunder, and (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territory, the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between the Development Plan and this Agreement, the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharma.
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4.5. Pharmacovigilance. Within ninety (90) days after written request by Anji Pharma, the Parties (either themselves of through their respective Affiliates or Sublicensees) shall enter into a written agreement to initiate a process for the exchange of safety data and information (including post-marketing spontaneous reports received by each Party and its Affiliates and Sublicensees) in a mutually agreed format in order to monitor the safety of the Compounds or Products and to meet reporting requirements with any applicable Regulatory Authority. Until such processes are set forth in a written agreement between the Parties, the Party responsible for pharmacovigilance prior to execution of such written agreement shall have sole pharmacovigilance responsibility for the Compound(s) and Products, subject to all Applicable Laws. In the event that such written agreement or this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance obligations are fulfilled.
| 5. | COMMERCIALIZATION ACTIVITIES. |
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5.3. Manufacturing. Anji Pharma shall have the exclusive right to Manufacture Products itself or through one or more of its Affiliates or Third Parties, in each case, selected by Anji Pharma in its sole discretion, provided, however, that if Anji Pharma desires to source Products from the same Manufacturers as LipimetiX, LipimetiX shall reasonably cooperate with the applicable Anji Pharma Related Party to make introductions, as necessary, and to the extent such Manufacturer is restricted from contracting with such Anji Pharma Related Party because of any agreement or arrangement such Manufacturer has with LipimetiX, LipimetiX shall deliver any necessary consents allowing for such Anji Pharma Related Party to enter into an agreement with such Manufacturer for the Manufacture of Compound or Product in the Field in the Territory.
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6.2. Filing, Prosecution and Maintenance of Patent Rights.
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6.3. Enforcement and Defense of Patent Rights.
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6.3.4. Allegations of Infringement and Right to Seek Third Party Licenses.
6.3.4.1. Notice. If the Development, Manufacture, Commercialization or use of any Compound or Product in the Field in the Territory, the practice of any LipimetiX IP or Product IP in the Field in the Territory or the exercise of any other right granted by LipimetiX to Anji Pharma hereunder (collectively, the “Licensed Activities”) by an Anji Pharma Related Party is alleged by a Third Party to infringe, misappropriate or otherwise violate such Third Party’s Patent Rights or other intellectual property rights (collectively, “Third Party IP Rights”), the Party becoming aware of such allegations shall promptly notify the other Party in writing. If either Party determines that, based upon the review of any Third Party IP Rights, it may be desirable to obtain a license from such Third Party with respect thereto so as to avoid any potential claim of infringement by such Third Party against either Party or their respective Affiliates or Sublicensees, then such Party shall promptly notify the other Party of such determination, and the Parties shall consult, in good faith, on the possibility of obtaining such license.
6.3.4.2. Anji Pharma Option to Negotiate. If Anji Pharma determines, after consultation with outside patent counsel, that, in order for an Anji Pharma Related Party to engage in the Licensed Activities, it is necessary (or desirable so as to avoid any potential claim of infringement by such Third Party) to obtain a license under one or more Third Party IP Rights, then Anji Pharma shall have the sole right, but not the obligation, to negotiate and enter into such a license or other agreement with the relevant Third Party.
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7.2.2.1. to Governmental Authorities (i) to obtain or maintain Regulatory Approvals for any Compound or Product within the Territory, and (ii) to respond to inquiries, requests or investigations relating to Compounds, Products or this Agreement;
7.2.2.2. to outside consultants, contractors, advisory boards, managed care organizations and non-clinical and clinical investigators that (a) have a need to know such Confidential Information in connection with the Development, registration or Commercialization of any Compound or Product in the Territory and (b) are bound by non-disclosure and non-use provisions with respect to such Confidential Information that are at least as restrictive as those set forth in this Article 7;
7.2.2.3. to any bona fide potential or actual investor, acquirer, merger partner, licensee or other financial or commercial partner for the sole purpose of evaluating an actual or potential investment, acquisition or other business relationship; provided, that in each case, the Disclosing Party has used Commercially Reasonable Efforts to have such partner agree in writing to non-disclosure and non-use provisions with respect to such Confidential Information that are at least as restrictive as those set forth in this Article 7;
7.2.2.4. in connection with filing or prosecuting Patent Rights or trademark rights as permitted by this Agreement,
7.2.2.5. in connection with prosecuting or defending litigation as permitted by this Agreement;
7.2.2.6. subject to the provisions of Section 7.5.2, in connection with, or included in, scientific presentations and publications relating to Compounds or Products, including abstracts, posters, journal articles and the like, and posting results of and other information about clinical trials; and
7.2.2.7. to enforce its rights under this Agreement.
If a Party deems it reasonably necessary to disclose Confidential Information belonging to the other Party pursuant to this Section 7.2.2, then such Party shall to the extent possible and legally and contractually permissible (a) give reasonable advance written notice of such disclosure to the other Party so as to allow the other Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information and (b) take such measures to ensure confidential treatment of such information as is reasonably required by the other Party, at the other Party’s sole cost and expense.
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7.5. Public Announcements; Publications.
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8. REPRESENTATIONS AND WARRANTIES.
8.1.1. it is duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization;
8.1.2. the execution, delivery and performance of this Agreement by such Party have been duly authorized by all requisite action under the provisions of its charter, bylaws and other organizational documents, and do not require any action or approval by any of its shareholders or other holders of its voting securities or voting interests;
8.1.3. it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder;
8.1.4. this Agreement has been duly executed and is a legal, valid and binding obligation on each Party, enforceable against such Party in accordance with its terms; and
8.1.5. the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions hereof does not and will not conflict with or result in a breach of, or default under, any agreement or arrangement, organizational document or governmental order, writ, injunction, decree or judgment or Applicable Law existing as of the Effective Date.
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8.3.1. except for the rights under the UABRF Agreement, LipimetiX is the sole and exclusive owner of the LipimetiX IP, all of which is free and clear of any claims, liens, charges or encumbrances;
8.3.2. it has the full right, power and authority to grant all of the right, title and interest in the licenses and other rights granted or to be granted to Anji Pharma under this Agreement;
8.3.3. (a) Exhibit A attached hereto sets forth a true and complete list of all Patent Rights owned or otherwise Controlled by LipimetiX or its Affiliates that relate to the Compounds or Product in the Territory or to the Development, Manufacture or use thereof in the Territory, and (b) LipimetiX or its Affiliates have paid all filing and renewal fees due and payable with respect to and have not abandoned such Patent Rights;
8.3.4. as of the Effective Date, LipimetiX has disclosed to Anji Pharma all material scientific and technical information and all material information relating to safety and efficacy known to it or its Affiliates with respect to the Compounds and Product (as it exists on the Effective Date);
8.3.5. no Third Party (a) is, to LipimetiX’s actual knowledge, infringing any LipimetiX Patent Right or (b) has in writing challenged or threatened to challenge the scope, validity or enforceability of any LipimetiX Patent Right (including, by way of example, through the institution or written threat of institution of interference, nullity or similar invalidity proceedings before the United States Patent and Trademark Office or any analogous foreign Governmental Authority);
8.3.6. to LipimetiX’s actual knowledge, it has complied in all material respects with all Applicable Laws, including any disclosure requirements, in connection with the filing, prosecution and maintenance of the LipimetiX Patent Rights;
8.3.7. it has obtained from all inventors of LipimetiX IP existing as of the Effective Date and from such inventor’s employer, as applicable, valid and enforceable agreements assigning to LipimetiX each such inventor’s and such inventor’s employer’s entire right, title and interest in and to all such LipimetiX IP;
8.3.8. no rights granted by or to LipimetiX or its Affiliates to any Third Party conflict with any right or license granted to Anji Pharma or its Affiliates hereunder; and
8.3.9. to LipimetiX’s actual knowledge, the use, Development, Manufacture or Commercialization under this Agreement of any Compounds or Product (as it exists on the Effective Date) in the Field in the Territory (a) does not infringe any issued patent of any Third Party or (b) will not infringe the claims of any published Third Party patent application when and if such claims issue in the form published as of the Effective Date.
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8.4.1. LipimetiX, subject to Section 11.1, shall not, and shall cause its Affiliates not to (a) license, sell, assign or otherwise transfer to any Person (other than an Anji Pharma Related Party pursuant to the terms of this Agreement) any LipimetiX IP or Product IP (or agree to do any of the foregoing), or (b) voluntarily incur or permit to exist, with respect to any LipimetiX IP, any lien, encumbrance, charge, security interest, mortgage, liability, assignment, grant of license or other agreement or arrangement, that is or would be inconsistent with the licenses and other rights granted to Anji Pharma under this Agreement.
8.4.2. LipimetiX will not (a) take any action that diminishes the rights under the LipimetiX IP or Product IP granted to Anji Pharma under this Agreement, or (b) fail to take any action that is reasonably necessary to avoid diminishing the rights under the LipimetiX IP granted to Anji Pharma under this Agreement.
8.4.3. LipimetiX will (a) not enter into any LipimetiX Third Party Agreement that (i) adversely affects the rights granted to Anji Pharma hereunder in any material respect, (ii) adversely affects LipimetiX’s ability to fully perform its obligations hereunder in any material respect, or (iii) places any additional obligations on an Anji Pharma Related Party; (b) not amend or otherwise modify any LipimetiX Third Party Agreement or consent or waive rights with respect thereto in any manner that (i) adversely affects the rights granted to Anji Pharma hereunder in any material respect, (ii) adversely affects LipimetiX’s ability to fully perform its obligations hereunder in any material respect or (iii) places any additional obligations on an Anji Pharma Related Party and (c) use Commercially Reasonable Efforts to remain, and cause its Affiliates to remain, in compliance in all material respects with all LipimetiX Third Party Agreements. LipimetiX shall promptly furnish Anji Pharma with true and complete copies of all amendments to any LipimetiX Third Party Agreement that affects the rights or obligations of any Anji Pharma Related Party under this Agreement and promptly notify Anji Pharma of any actual or alleged breach or default that would be reasonably expected to adversely affect the rights in any material respect.
8.4.4. LipimetiX will use Commercially Reasonable Efforts to maintain valid and enforceable agreements with all Persons acting by, or on behalf of, LipimetiX or its Affiliates under this Agreement, which require such Persons to assign to LipimetiX their entire right, title and interest in and to all LipimetiX IP, and in the event that any issues arise, LipimetiX will promptly notify Anji Pharma, and the Parties will seek to resolve the issue.
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9.6. Termination for Patent Challenge.
9.6.1. LipimetiX shall have the right to terminate this Agreement in its entirety in the event Anji Pharma or any of its Affiliates challenges or knowingly and intentionally supports (other than as may be necessary or reasonably required to assert a cross-claim or a counter-claim, or in response to a subpoena or court or administrative law request or order), including by providing information, documents, and/or funding, a challenge to the validity, scope, enforceability or patentability of any of the LipimetiX Patent Rights, in each case, in a formal judicial proceeding or administrative action. LipimetiX ’s right to terminate this Agreement under this Section 9.6.1 may be exercised at any time after Anji Pharma or any of its Affiliates may have challenged or knowingly and intentionally supports (other than in response to a subpoena or court order) a challenge to the validity, scope, enforceability or patentability of any of the LipimetiX Patent Rights, provided that such proceeding or action is not withdrawn or terminated within thirty (30) days after Anji Pharma receives notice from LipimetiX of such exercise of termination rights.
9.6.2. If a Sublicensee of Anji Pharma or its Affiliate challenges, in a formal judicial proceeding or administrative action, the validity, scope or enforceability of any of the LipimetiX Patent Rights under which such Sublicensee is sublicensed, then Anji Pharma or its Affiliate, as the case may be, shall, at LipimetiX’s election and upon written notice from LipimetiX, promptly terminate such sublicense, provided that such proceeding or action is not withdrawn or terminated within thirty (30) days after Anji Pharma receives notice from LipimetiX of such exercise of termination rights. Anji Pharma shall, and shall cause its Affiliates, as the case may be, to include within each sublicense agreement with each Sublicensee a similar right on the part of Anji Pharma or such Affiliate to terminate such sublicense agreement. If Anji Pharma or its Affiliate fails to exercise such termination right against such Sublicensee or is unable to do so because it did not include such a provision in its Sublicense, LipimetiX may immediately terminate this Agreement with respect to the rights granted to such Sublicensee.
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such termination, provided that the Sublicensee is not in breach of any of its obligations under such sublicense at the time of termination and provided, further, such Sublicensee has not challenged (as described in Section 9.6.2) a LipimetiX Patent Right; in order to effect this survival, at the request of the Sublicensee, such sublicense shall remain in effect and be assigned to LipimetiX on substantially the same terms with LipimetiX deemed for all purposes to be the licensor thereunder provided that (a) the sublicense is consistent with the terms of this Agreement; (b) LipimetiX shall have no obligations under such sublicenses other than to preserve the effectiveness, scope and validity of the licenses granted therein under the LipimetiX IP and LipimetiX’s rights in the Product IP , and to provide such Sublicensee with information and rights of access which LipimetiX has an obligation to provide to Anji Pharma under this Agreement, but not to exceed in scope Anji Pharma’s obligations to provide information and rights of access to such Sublicensee under the applicable agreement; (c) no representation, warranty or indemnification provision shall exceed those given to Anji Pharma under this Agreement; and (d) further provided that such Sublicensee enters into an assignment agreement directly with LipimetiX to effectuate such assignment. LipimetiX shall be entitled to all payments accrued under such sublicense after the date of termination of this Agreement, and subject to effective assignment under this Section 9.7.1, (but excluding any duplicate payments) from each Sublicensee under any such sublicense in accordance with the terms of such sublicense. Subject in all cases to the survival of any rights of Sublicensees in any surviving sublicense under this Agreement, in the event of a termination by Anji Pharma under Section 9.2 or a termination by LipimetiX under Section 9.3, 9.4, 9.5 or 9.6 and upon written request from LipimetiX, Anji Pharma (a) shall grant a perpetual, worldwide, fully paid, royalty-free, fully sublicensable through multiple tiers, exclusive license to LipimetiX, under (i) Anji Pharma’s rights in any Product IP, or (ii) Anji Pharma IP, in each case that is necessary to, or used by, the Anji Pharma Related Parties as of the date of termination in their efforts to use, Develop, Manufacture and Commercialize the Compounds and Products in the Field in the Territory, and (b) shall transfer to LipimetiX copies of any embodiments of such Technology and shall assign and transfer to LipimetiX any and all of its rights, title and interest in and to any Regulatory Approvals, regulatory documents and regulatory communications then owned (in whole or in part) or otherwise Controlled by an Anji Pharma Related Party that is related to any Compound or Product in the Territory.
9.7.3. Survival Period. The following sections, together with any sections that expressly survive (including any perpetual licenses granted hereunder) as well as any other provisions which by their nature are intended to survive expiration or termination, shall survive expiration or termination of this Agreement for any reason: Sections 1, 2.1.2, 2.2.3, 2.4, 2.8, 3.5, 3.6, 3.7, 3.8, 3.9, 3.10, 3.11, 3.11.1, 3.11.2, 6.1, 7, 8.6, 9.7, 9.8, 10.1, 10.2, 10.3, 10.4, 10.5 and 11.
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10. LIMITATION ON LIABILITY, INDEMNIFICATION AND INSURANCE.
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if to Anji Pharma:
Anji Pharmaceuticals Inc.
0 Xxxx Xxxx
Xxxxxxx, XX 00000
Attn.: Chief Scientific Officer
Email: xxxxx@xxxxxxxxxx.xxx
with a copy to:
Xxxxx Xxxx LLP
000 Xxxxxxx Xxxxxxxxx
Xxxxxx, XX 00000
Attn.: Xxxxx Xxxxxxxx
Email: xxxxxxxxx@xxxxxxxxx.xxx
Facsimile: 000 000 0000
if to LipimetiX:
LipimetiX Development, Inc.
0 Xxxxxxxxxxxx Xxxx, Xxxxx 0x
Xxxxxx, XX 00000
Attn.: Xxxxxx X. Xxxxxxxx, PhD, President and CEO
Email: xxxxxxxxx@xxxxxxx.xxx
Facsimile: 000 000 0000
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with a copy to:
LipimetiX Development, Inc.
0000 X Xxxx Xxxxx
Xxxxxxxx Xxxxxx, XX 00000
Attn.: Xxxx X. Xxxxxxxx, III, Executive Chairman
Email: xxxxxxxxx@xxxxxxxxxxx.xxx
Facsimile: 000 000 0000
XxXxxxxxx Will & Xxxxx LLP
00 Xxxxx Xxxxxx
Xxxxxx, XX 00000
Attn.: Xxxxxxx X. Xxxxx
Email: xxxxxxx@xxx.xxx
Facsimile: 000 000 0000
11.9.1. If such dispute involves facts that might form a reasonable basis to allege that Anji Pharma has failed to meet any of its obligations under Section 4.3 or 5.5, then LipimetiX will promptly notify Anji Pharma in writing of such potential alleged performance failure or dispute (each such potential alleged performance failure or dispute, a “Diligence Issue”). Promptly upon Anji Pharma’s receipt of any notice of a Diligence Issue pursuant to this Section 11.9.1, the Parties shall meet and use their reasonable efforts to resolve the Diligence Issue, and if no resolution is reached within sixty (60) days, then the Parties shall try to resolve the Diligence Issue pursuant to the dispute resolution provisions set forth in Sections 11.9.3 and 11.9.4.
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11.9.2. For all other disputes, the Party claiming that such a dispute exists shall give notice in writing (“Notice of Dispute”) to the other Party of the nature of the dispute.
11.9.3. Within fourteen (14) days of receipt of a Notice of Dispute or, with respect to a Diligence Issue, of failure to resolve such Diligence Issue in accordance with Section 11.9.1, the Chief Executive Officer of LipimetiX and the Chief Executive Officer of Anji Pharma (the “Executive Officers”) shall meet in person or by teleconference and exchange written summaries reflecting, in reasonable detail, the nature and extent of the dispute, and at this meeting they shall use their reasonable efforts to resolve the dispute; provided, however, that such Executive Officers may each designate a senior executive to whom the dispute may be delegated for such attempted resolution.
11.9.4. If, within ninety (90) days of initial receipt of the Notice of Dispute, the dispute has not been resolved, then the Parties agree that either Party may initiate arbitration procedures set forth in Section 11.11 to resolve the dispute.
Notwithstanding any provision of this Agreement to the contrary, either Party may immediately initiate litigation in any court of competent jurisdiction seeking any remedy at law or in equity, including the issuance of a preliminary, temporary or permanent injunction, or for specific performance, to preserve or enforce its rights under this Agreement. The provisions of this Section 11.9 will survive for five (5) years after the date of termination or expiration of this Agreement.
11.10. Governing Law. This Agreement, and all claims arising under or in connection therewith, shall be governed by, and interpreted in accordance with, the substantive laws of the State of Delaware, without regard to conflict of law principles thereof.
11.11.1. the arbitration shall be conducted by three (3) arbitrators appointed by the ICC, who shall be experienced in the pharmaceutical business in the relevant jurisdiction;
11.11.2. the place of arbitration shall be Boston, Massachusetts, USA, and all proceedings and communications shall be in English, unless otherwise agreed by all Parties involved in such dispute;
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11.11.3. any Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the dispute is otherwise resolved;
11.11.4. notwithstanding anything herein to the contrary, any Party also may, without waiving any remedy under this Agreement, seek from any court of competent jurisdiction any temporary restraining order, preliminary injunction or other interim equitable relief necessary to protect the rights, property or interests of that Party pending the arbitration award (and this Section 11.11.4 shall be specifically enforceable);
11.11.5. the arbitrators shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damage;
11.11.6. the prevailing Party shall be entitled to recover from the other Party its sole costs and expenses and attorneys’ fees reasonably incurred by such prevailing Party in connection with the dispute;
11.11.7. this Section 11.11 shall apply to any claims by or against the Parties and their respective Affiliates and any agents, principals, officers, directors or employees of either of the Parties or their respective Affiliates;
11.11.8. except to the extent necessary to confirm an award or as may be required by Applicable Law, neither a Party nor the arbitrators may publicly disclose the existence, content or results of an arbitration, which shall be considered Confidential Information of both Parties, without the prior written consent of all Parties; and
11.11.9. in no event shall an arbitration be initiated after the date when commencement of a legal or equitable proceeding, based on the relevant dispute would have been barred by the applicable statute of limitations.
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(Signature page follows.)
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| ANJI PHARMACEUTICALS INC. | |||
| By | /S/ Xxxxx Xxxx | ||
| Name: | Xxxxx Xxxx, Ph.D. | ||
| Title: | Chief Executive Officer |
| LIPIMETIX DEVELOPMENT, INC. | |||
| By | /S/ Xxxxxx X. Xxxxxxxx | ||
|
Name: | Xxxxxx X. Xxxxxxxx, Ph.D. | ||
| Title: | President and CEO |
Exhibit A
LipimetiX Patent Rights Existing as of the Effective Date
LICENSED PATENTS and IP
Updated April 25, 2017
All of the technology covered by the patents and patent applications listed below were created and conceived through the use of federal funds with the exception of patent filings related to UABRF intellectual property disclosure No. U2014-0016.
(U1996-0082)
U.S. Patent No. 6,156,727, “Anti-atherosclerotic peptides and a transgenic mouse model of atherosclerosis,” Xxxxxx, Xxxxx X.; Anantharamaiah, Xxxxxxxxxxxx X., filed September 5, 1997 and issued December 5, 2000.
(U1998-0016)
U.S. Patent No. 6,506,880, “Synthetic peptides that enhance atherogenic lipoprotein uptake and lower plasma cholesterol,” Anantharamaiah, Xxxxxxxxxxxx X., filed March 7, 2000 and issued January 14, 2003.
(U2001-0085)
U.S. Patent No. 7,563,771, “Synthetic single domain polypeptides mimicking apolipoprotein E,” Anantharamaiah, Xxxxxxxxxxxx X.; Xxxxxx, Xxxxx X.; Xxxxx, Xxxxx, filed November 13, 2003 and issued July 21, 2009.
The corresponding foreign patents granted include:
Australian Patent No. 2003290825, filed August 4, 2005 and issued May 21, 2009.
Canadian Patent Application No. 2,514,303, filed October 26, 2005 and issued September 18, 2012.
New Zealand Patent No. 541504, filed July 28, 2005 and issued August 13, 2009.
European Patent No. 03783409.0, filed November 1, 2005 and issued February 22, 2017.
European Patent No. 1599173, filed February 21, 2017 and issued February 22, 2017.
(U2006-0028)
U.S. Patent No. 8,084,423, “Synthetic single domain polypeptides mimicking apolipoprotein E and methods of use,” Anantharamaiah, Xxxxxxxxxxxx X.; Xxxxxx, Xxxxx X.; Xxxxx, Xxxxx, filed April 17, 2006 and issued December 27, 2011.
(U2007-0040)
U.S. Provisional Patent Application No. 60/968,362, filed August 28, 2007.
International Application No. PCT/US2008/074470, “Synthetic apolipoprotein E mimicking polypeptides and methods of use,” Anantharamaiah, Xxxxxxxxxxxx X., Xxxxx, Xxxxxxxx; White, C. Xxxxx, filed on August 27, 2008.
The corresponding patent applications filed include:
Canadian Patent Application No. 2,704,729, filed February 25, 2010.
The corresponding patent applications published include:
U.S. Patent Application No. 12/675,089, filed February 24, 2010 and published November 25, 2010.
U.S. Patent Application 14/851,089, filed September 11, 2015 and published September 22, 2016.
The corresponding foreign patents granted include:
Australian Patent No. 2008296478, filed March 19, 2010 and issued December 11, 2014.
European Patent No. 2195331, filed February 25, 2010 and issued November 20, 2013.
(U2009-0096)
UAB intellectual property disclosure entitled “A 12-Residue Cationic Cholesterol Reducing Peptide,” disclosed September 16, 2009.
(U2011-0045)
UAB intellectual property disclosure entitled “New Highly Active Short Peptides that Function Analogous to Apolipoprotein E,” disclosed April 14, 2011.
(U2012-0105)
UAB intellectual property disclosure entitled “ApoE Mimetics with Enhanced Atheroprotective Potential,” disclosed September 6, 2012.
(U2013-0020)
U.S. Provisional Patent Application No. 61/782,956, “Apolipoprotein Mimetics and Uses Thereof,” Anantharamaiah; Xxxxxxxxxxxx X., Xxxxxxxx; Xxxxxx X., filed on March 14, 2013.
U.S. Provisional Patent Application No. 61/349,992, “Apolipoprotein Mimetics and Uses Thereof,” Anantharamaiah; Xxxxxxxxxxxx X., Xxxxxxxx; Xxxxxx X., filed on June 14, 2013.
International Application No. PCT/US2014/27719, “Apolipoprotein Mimetics and Uses Thereof,” Anantharamaiah; Xxxxxxxxxxxx X., Xxxxxxxx; Xxxxxx X., filed on March 14, 2014.
The corresponding foreign patent applications filed include:
Australian Patent Application No. 2014239186, filed September 14, 2015.
Brazilian Patent Application No. 11 2015 022624, filed September 11, 2015.
Canadian Patent Application No. 2,903,869, filed September 2, 2015.
European Patent Application No. 14769489.7, filed October 12, 2015.
Indian Patent Application No. 6250/CHENP/2015, filed October 9, 2015.
Israeli Patent Application No. 240787, filed September 18, 2015.
Japanese Patent Application No. 2016-502527, filed November 11, 2015.
Mexican Patent Application No. MX/a/2015/012818, filed September 14, 2015.
New Zealand Patent Application No. 713291, filed October 14, 2015.
South African Patent Application No. 2015/06980, filed September 18, 2015.
The corresponding patent application published is:
U.S. Patent Application No. 14/770,270, filed August 25, 2015 and published January 7, 2016.
(U2014-0016)
U.S. Provisional Patent Application No.62/031,585, “ApoE Mimetic Peptides and Higher Potency to Clear Plasma Cholesterol,” Anantharamaiah; Xxxxxxxxxxxx X., Xxxxxxxx; Xxxxxx X., filed on July 31, 2014.
International Application No. PCT/US2015/041162, “ApoE Mimetic Peptides and Higher Potency to Clear Plasma Cholesterol,” Anantharamaiah; Xxxxxxxxxxxx X., Xxxxxxxx; Xxxxxx X., filed on July 20, 2015.
The corresponding patent applications filed include:
U.S. Patent Application No. 15/329,735, filed January 27, 2017.
Australian Patent Application No. 2015298263, filed February 24, 2017.
Brazilian Patent Application (awaiting Serial No.), filed January 20, 2017.
Canadian Patent Application (awaiting Serial No.), filed January 6, 2017.
Chinese Patent Application No. 2015800419130, filed March 1, 2017.
Egyptian Patent Application No. 0223357, filed January 22, 2017.
European Patent Application No. 15826624.4, filed February 27, 2017.
Indian Patent Application No. 201717007083, filed February 28, 2017.
Iranian Patent Application No. (awaiting Serial No.), filed January 20, 2017.
Israeli Patent Application No. 250302, filed January 26, 2017.
Japanese Patent Application No. 2017-505143, filed January 30, 2017.
Mexican Patent Application No. MX/a/2017/001432, filed January 31, 2017.
New Zealand Patent Application No. 729580, filed February 27, 2017.
Saudi Arabian Patent Application No. (awaiting Serial No.), filed January 20, 2017
(U2017-0011)
UAB intellectual property disclosure entitled “Retinoic Acid Conjugate of Apo E Mimetic Peptides as Dyslipidemic and Anti-Oncogenic Agents,” disclosed December 1, 2016.
(U2017-0029)
UAB intellectual property disclosure entitled “Apo E Mimetic Peptides with Enhanced Potency for Anti-Inflammatory Properties,” disclosed April 12, 2017.
LIPIMETIX PATENTS and IP
U.S. Provisional Patent Application No.62/066,018, “ApoE Mimetic Peptide Compositions,” Xxxxxxxx; Xxxxxx X., Xxxxxx, Xxxxxxx X., filed on October 20, 2014.
U.S. Provisional Patent Application No.62/288,748, “ApoE Mimetic Peptide Compositions,” Xxxxxx, Xxxxxxx X., Xxxxxxxx; Xxxxxx X., filed on January 29, 2016.
U.S. Provisional Patent Application No.62/655,955, “ApoE Mimetic Peptide Compositions,” Xxxxxxxx; Xxxxxx X., Xxxxxxxx, Xxxxxx X., filed on April 11, 2018.
Exhibit B
Press Release
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0 Xxxxxxxxxxxx Xxxx - Xxxxx 0X Xxxxxx, XX 00000 (508)651-3715 xxx.xxxxxxxxx.xxx
|
LipimetiX Development Announces Sub-License of Apo E Mimetic Peptide Platform to Anji Pharma, China
Natick, MA – May _, 2018 ─ LipimetiX Development, Inc. (“LipimetiX” or “the Company”) announced today that Anji Pharmaceuticals, Inc. (“Anji Pharma”) has entered a licensing agreement for the LipimetiX platform of peptides (AEM-28 and analogs) for development of these drug candidates in commercial indications in mainland China, Taiwan and Hong Kong. Anji Pharma’s mission is to license and develop promising therapeutic technologies that address under-served markets in China.
The Anji Pharma’s license provides exclusive rights to and use of the LipimetiX patent portfolio of Apo E mimetic peptides and formulations in the above-mentioned territory. Terms include an upfront licensing payment to LipimetiX of US$2.0 million, multiple additional cash payments upon achievement of clinical/regulatory milestones and a royalty on Anji Pharma’s future pharmaceutical revenues derived from this program. Further, the agreement provides for information sharing and other terms standard to a licensing agreement of this nature.
Xxxxxx Xxxxxxxx, Ph.D., CEO of LipimetiX stated “We welcome the Anji Pharma relationship to develop our lipid-lowering peptides in China. The business opportunity was brought to us by a member of the LipimetiX Science Advisory Board, who has closely observed and contributed to our program’s success. We are pleased by this validation of our science in Apo E mimetic peptides.”
Xxxxx Xxxx, Ph.D., CEO of Anji Pharma added “We are excited to collaborate with LipimetiX in a program to address a large China and global clinical need. The LipimetiX team has already shown proof-of-concept in lipid reduction in humans with AEM-28. We look forward to helping progress these potent peptides through the next clinical development phases and, ultimately, to the market.”
Chimeric Apolipoprotein E Mimetic Peptides
Apolipoprotein E (Apo E) is in a class of protein that occurs throughout the body. Apo E is essential for the normal metabolism of cholesterol and triglycerides. After a meal, the postprandial (or post-meal) lipid load is packaged in lipoproteins and secreted into the blood stream. Apo E targets cholesterol and triglyceride rich lipoproteins to specific receptors in the liver, decreasing the levels in the blood. Elevated plasma cholesterol and triglycerides are independent risk factors for atherosclerosis, the buildup of cholesterol rich lesions and plaques in the arteries. Atherosclerosis is the major cause of cardiovascular disease, peripheral artery disease and cerebral artery disease, and can cause heart attack, loss of limbs and stroke. Defective lipid metabolism also plays an important role in the development of adult onset diabetes mellitus (Type 2 diabetes), and diabetics are particularly vulnerable to atherosclerosis, heart and peripheral artery diseases.
The University of Alabama at Birmingham (“UAB”) scientists patented the first chimeric Apo E mimetic peptide in 1999, reducing the 299 amino acid native Apo E into a 28 amino acid, dual domain peptide that can be delivered therapeutically. One domain inserts into a lipoprotein surface and the second domain binds to the Apo E receptors in the liver. In 2010, the Company’s founding scientist, Xx. Xxxxxx Xxxxxxxx, obtained worldwide right to patents for Apo E mimetic peptides from the UAB Research Foundation (“UABRF”). The Company has an Exclusive License Agreement with the University of Alabama at Birmingham Research Foundation for AEM-28 and its analogs.
The Company has continued research into a next generation of chimeric Apo E peptides and has discovered new AEM-28 analogs, resulting in worldwide patent filings in 2015. The AEM-28 analogs were found to be significantly more potent (as tested in multiple animal models) than the parent molecule. Currently, the Company intends to concentrate its development efforts on AEM-28 analogs, including AEM-28-08 and AEM-28-14. Commercial indication targets include Homozygous Familial Hypercholesterolemia and Acute Coronary Syndrome.
About Anji
Anji Pharma is a clinical stage pharmaceutical company dedicated to addressing China’s unmet clinical needs by identifying and in-licensing world-class clinical compounds and accelerating their clinical development in China.
About LipimetiX
LipimetiX Development, Inc. is a clinical stage biotechnology company committed to developing Chimeric Apo E Mimetic Peptides for multiple lipid reduction indications. LipimetiX is approximately 60%-owned by Capstone Therapeutics Corp. (OTCQB:CAPS).
Capstone’s corporate headquarters are in Tempe, Arizona. For more information, please visit Capstone's website: xxx.xxxxxxxxxxx.xxx. For more information on LipimetiX Development, please visit the Company’s website: xxx.xxxxxxxxx.xxx.
Statements in this press release or otherwise attributable to Capstone regarding our business that are not historical facts are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted results. These risks include the factors discussed in our Form 10-K for the fiscal year ended December 31, 2017, and other documents that Capstone files with the U.S. Securities and Exchange Commission.
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Editor’s Note: This press release is also available under the Investors section of Capstone’s website at xxx.xxxxxxxxxxx.xxx.
EXHIBIT C
UABRF Agreement
A copy of the UAB Research Foundation Exclusive License Agreement was attached as Exhibit 10.7 to the Company’s Quarterly Report on Form 10-Q for the period ending June 30, 2012 filed with Securities and Exchange Commission (‘SEC”) on August 10, 2012. A copy of the First Amendment and Consent to Assignment of the Exclusive License Agreement was attached as Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the period ending June 30, 2012 filed with the SEC on August 10, 2012. The Second Amendment to the Exclusive License Agreement was attached as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on January 30, 2015.