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As Of Filer Filing For·On·As Docs:Size Issuer Agent 6/12/15 Cerecor Inc. S-1 24:7.0M Merrill Corp/New/FA |
Document/Exhibit Description Pages Size 1: S-1 Registration Statement (General Form) HTML 1.80M 2: EX-3.1 Articles of Incorporation/Organization or By-Laws HTML 155K 3: EX-3.3 Articles of Incorporation/Organization or By-Laws HTML 137K 4: EX-4.1 Instrument Defining the Rights of Security Holders HTML 210K 5: EX-4.2 Instrument Defining the Rights of Security Holders HTML 41K 6: EX-4.3 Instrument Defining the Rights of Security Holders HTML 55K 7: EX-4.4 Instrument Defining the Rights of Security Holders HTML 41K 8: EX-4.5 Instrument Defining the Rights of Security Holders HTML 43K 9: EX-4.6 Instrument Defining the Rights of Security Holders HTML 42K 10: EX-4.7 Instrument Defining the Rights of Security Holders HTML 110K 11: EX-4.8 Instrument Defining the Rights of Security Holders HTML 33K 12: EX-10.1 Material Contract HTML 326K 20: EX-10.10 Material Contract HTML 64K 21: EX-10.11 Material Contract HTML 19K 22: EX-10.14 Material Contract HTML 379K 23: EX-10.15 Material Contract HTML 260K 13: EX-10.2 Material Contract HTML 269K 14: EX-10.3 Material Contract HTML 368K 15: EX-10.4 Material Contract HTML 243K 16: EX-10.6 Material Contract HTML 63K 17: EX-10.7 Material Contract HTML 65K 18: EX-10.8 Material Contract HTML 68K 19: EX-10.9 Material Contract HTML 68K 24: EX-23.1 Consent of Experts or Counsel HTML 9K
Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.
EXCLUSIVE PATENT AND KNOW-HOW LICENSE AGREEMENT
by and between
Eli Lilly and Company and
CERECOR INC.
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| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
EXCLUSIVE PATENT AND KNOW HOW LICENSE AGREEMENT
THIS EXCLUSIVE PATENT AND KNOW-HOW LICENSE AGREEMENT (this "Agreement"), effective as of this 18th day of February, 2015 (the "Effective Date"), is by and between Eli Lilly and Company ("Lilly"), and Cerecor Inc. ("Cerecor"), a corporation organized and existing under the laws of Delaware (hereinafter referred to as "Licensee"). Lilly and Licensee are sometimes referred to herein individually as a "Party" and collectively as the "Parties".
WHEREAS, Lilly and its Affiliates have discovered and developed the Kappa opioid receptor antagonist designated as LY2456302;
WHEREAS, Licensee desires to develop and commercialize LY2456302; and
WHEREAS, Licensee and Lilly desire to enter into a license arrangement whereby Licensee will develop and commercialize LY2456302.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, Licensee and Lilly hereby agree as follows:
As used in this Agreement, the following capitalized terms, whether used in the singular or plural, shall have the respective meanings set forth below:
1.01 "Affiliate" shall mean any individual or entity directly or indirectly controlling, controlled by or under common control with a Party to this Agreement. For purposes of this Agreement, the direct or indirect ownership of fifty percent (50%) or more of the outstanding voting securities of an entity, or the right to receive fifty percent (50%) or more of the profits or earnings of an entity, shall be deemed to constitute control. Such other relationship as in fact results in actual control over the management, business and affairs of an entity shall also be deemed to constitute control.
1.02 "Calendar Quarter" shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31, for so long as this Agreement is in effect.
1.03 "Calendar Year" shall mean each successive period of twelve (12) months commencing on January 1 and ending on December 31, for so long as this Agreement is in effect.
1.04 "Change of Control" shall mean with respect to a Party: (a) the sale to a Third Party of all or substantially all of such Party's assets and business; (b) a merger, reorganization or consolidation involving such Party and a Third Party in which the voting securities of such Party outstanding immediately prior thereto ceases to represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization or consolidation; or (c) a person or entity, or group of persons or entities, acting in concert acquire more than fifty percent (50%) of the voting equity securities or management control of such Party. Notwithstanding the foregoing, a Change of Control shall not be deemed to occur (i) on account of the acquisition of securities of a Party by any institutional investor, or affiliate thereof, or similar investor, that acquires the Party's securities in a transaction or series of related transactions that are primarily a private financing transaction of the Party or (ii) a sale of assets, merger, or other transaction effected exclusively for the purpose of changing domicile of the Party. For clarity, any public offering of a Party's equity securities shall not be deemed to be a Change of Control.
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| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
1.05 "Clinical Trial" shall mean a Phase I Clinical Trial, Phase II Clinical Trial, Phase III clinical Trial, Phase IIIb Clinical Trial and/or post-approval clinical trial.
1.06 "Commercialization" or "Commercialize" shall mean, with respect to Licensed Product, any and all activities directed to the marketing, promotion, distribution, offering for sale and selling such product, importing and exporting such product for sale, and interacting with Regulatory Authorities regarding the foregoing. Commercialization shall also include Commercialization Studies. "Commercialize" has a correlative meaning.
1.07 "Commercialization Studies" shall mean a study or data collection effort for the Licensed Product that is initiated in the Territory after receipt of Marketing Authorization for the Licensed Product and is principally intended to support the Commercialization of the Licensed Product in the Territory; provided, that such study or data collection effort is not principally to support or maintain a Marketing Authorization or obtain a label change or maintain a label.
1.08 "Commercially Reasonable Efforts" shall mean, with respect to the performance of obligations or tasks of a Party, the level of efforts and resources, normally used by a similarly situated biopharmaceutical company in the exercise of its reasonable discretion relating to the Development or commercialization of a product, in each case owned by it or to which it has exclusive rights, having similar technical and regulatory factors and similar market potential, profit potential and strategic value, and that is at a similar stage in its Development or product life cycle as the Licensed Product, taking into account issues of patent coverage, safety and efficacy, product profile, competiveness of the marketplace, proprie- tary position, and profitability (including pricing and reimbursement).
1.09 "Development" or "Develop" shall mean all preclinical research and development activities and all clinical drug development activities, including, among other things: drug discovery, toxicology, formulation, statistical analysis and report writing, conducting clinical trials for the purpose of obtaining and maintaining Marketing Authorization (including without limitation, post-marketing studies), and regulatory affairs related to all of the foregoing. Development shall include all clinical studies (including Phase III-B) that are primarily intended to support or maintain a Marketing Authorization, maintain a label or obtain any label change, but shall exclude Commercialization Studies.
1.10 "Field" shall mean the prevention, diagnosis and/or treatment of all disease in humans.
1.11 "First Commercial Sale" shall mean, with respect to a particular Licensed Product in a particular country in the Territory, the first commercial sale of such Licensed Product to a Third Party for end use or consumption in such country in an arm's length transaction by Licensee, its Affiliates or sublicensee in the Field after the receipt of Marketing Authorization in such country. Sales for test marketing, sampling and promotional uses, Clinical Trial purposes or compassionate or similar use shall not be considered to constitute a First Commercial Sale.
1.12 "Generic Product" means, with respect to a particular Licensed Product in a country, a generic or biosimilar pharmaceutical product, that is not produced, licensed or owned by Licensee or any of its Affiliates, that: (a) contains the same, or a bioequivalent of the, active ingredient as a Licensed Product; and (b) is approved for use in such country by a regulatory authority through a regulatory pathway by referencing clinical data first submitted for obtaining regulatory approval for such Licensed Product. Generic Product includes any pharmaceutical products obtained via a bioequivalence or bioavailability showing such as those covered by section 505(b)(2) or under 5050(j) of the U.S. Federal Food, Drug, and Cosmetic Act or an equivalent outside the United States.
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| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
1.13 "Good Clinical Practices" shall mean the then current Good Clinical Practices as such term is defined from time to time by the United States Food and Drug Administration ("FDA"), or analogous set of regulations, guidelines or standards as defined by other relevant Regulatory Authority having jurisdiction over the Development, Manufacture or sale of Licensed Product in a particular jurisdiction of the Territory, if and to the extent the Development, Manufacture or sale of Licensed Product takes place in such jurisdiction.
1.14 "Good Laboratory Practices" shall mean the then current good laboratory practice regulations of the FDA as described in the United States Code of Federal Regulations ("CFR") or analogous set of regulations, guidelines or standards as defined by other relevant Regulatory Authority having jurisdiction over the Development, Manufacture or sale of Licensed Product in a particular jurisdiction of the Territory, if and to the extent the Development, Manufacture or sale of Licensed Product takes place in such jurisdiction.
1.15 "Good Manufacturing Practices" shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or analogous set of regulations, guidelines or standards as defined by other relevant Regulatory Authority having jurisdiction over the Development, Manufacture or sale of Licensed Compound or Licensed Product in a particular jurisdiction of the Territory, if and to the extent the Development, Manufacture or sale of Licensed Compound or Licensed Product takes place in such jurisdiction.
1.16 "IND" shall mean an investigational new drug application with respect to the Licensed Product filed with the FDA for beginning Clinical Trials in humans, or any comparable application filed with the Regulatory Authorities of a country other than the United States prior to beginning Clinical Trials in humans in that country, as well as all supplements or amendments filed with respect to such filings.
1.17 "Kappa Opioid Receptor Antagonist" shall mean an opioid receptor antagonist or inverse agonist which selectively targets kappa opioid receptors, but shall not include opioid receptor antagonists or inverse agonists with mixed or nonselective pharmacological actions.
1.18 "Know-How" shall mean scientific and technical information, trade secrets and data used or generated and owned or controlled, by a Party or on behalf of a Party, which are based on, derived from, or are directed to the Lilly Patent Rights with respect to Lilly Know-How, Licensee Patent Rights with respect to Licensee Know-How, Licensed Compounds or Licensed Products, or the manufacture or use of the foregoing, that are not in the public domain, including but not limited to (a) unpatented ideas, discoveries, inventions, or improvements, (b) information related to methods, procedures, formulas, processes, tests, assays, techniques, regulatory requirements and strategies useful in the development, testing, or analysis of the Licensed Compounds or Licensed Products, (c) medicinal chemistry, medical, pre-clinical, toxicological biological, chemical, pharmacological, safety, manufacturing and quality control data or other scientific data and information related thereto, and (iv) drawings, plans, designs, diagrams, sketches, specifications or other documents containing or relating to such information.
1.19 "Licensee" shall have the meaning given to such term in the preamble of this Agreement.
1.20 "Licensee Know-How" shall mean Know-How developed by Licensee and/or any of its Affiliates or sublicensees after the Effective Date pursuant to this Agreement that is necessary for the Development, Commercialization or Manufacture of Licensed Compound or Licensed Product.
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| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
1.21 "Licensee Patent Rights" shall mean those patents and patent applications including all (a) continuations, continuations-in-part, divisionals and substitute applications with respect to any such patent applications; (b) patents issued based on or claiming priority to any such patent applications; (c) any reissue, reexamination, renewal, extension (including any supplemental protection certificate) or restoration of any such patents; (d) any confirmation patent or registration patent or patent of addition based on any such patents; (e) foreign counterparts and (f) any other patents and patent applications that dominate the foregoing patents, that (x) are owned by Licensee as of the effective date of termination of this Agreement, and (y) claim the Licensed Compound or Licensed Product or their use, composition, formulation, preparation or manufacture.
1.22 "Licensed Compound" shall mean those compounds listed in Schedule 1.23, including salts, esters, metabolites, prodrugs, acid forms, base forms, steroisomers, racemates, tautomers, polymorphs, solvates, hydrates and crystalline forms thereof.
1.23 "Licensed Product" shall mean any pharmaceutical product containing a Licensed Compound, including all dosage forms, formulations and line extensions thereof, including, without limitation, a Combination Product, except for calculation of Net Sales in Section 1.32.
1.24 "Lilly" shall have the meaning given to such term in the preamble to this Agreement.
1.25 "Lilly Know-How" shall mean the Know-How (a) owned or controlled by Lilly and/or any of its Affiliates as of the Effective Date, and/or (b) controlled by Lilly pursuant to a written agreement between Lilly and a Third Party executed during the Term for which Licensee has elected to pay Third Party License Expenses in accordance with Section 2.06, in each of (a) and (b) that was (i) used or generated by or on behalf of Lilly or its Affiliates prior to the Effective Date in the Development or Manufacture of Licensed Compound or Licensed Product or (ii) that is necessary or useful for the Development, Commercialization or Manufacture of Licensed Compound or Licensed Product. Lilly Know-How shall include without limitation the Know-How that is listed on Schedule 1.26 or is otherwise provided to Licensee by Lilly under this Agreement.
1.26 "Lilly Patent Rights" shall mean solely (a) those patents and patent applications listed in Schedule 1.27, and/or (b) those patent and patent applications controlled by Lilly pursuant to a written agreement between Lilly and a Third Party executed during the Term for which Licensee has elected to pay Third Party License Expenses in accordance with Section 2.06, and in each of (a) and (b) all of Lilly's rights together with all inventions disclosed or claimed therein or covered thereby including all (i) continuations, continuations-in-part, divisionals and substitute applications with respect to any such patent applications; (ii) patents issued based on or claiming priority to any such patent applications; (iii) any reissue, reexamination, renewal, extension (including any supplemental protection certificate) or restoration of any such patents; (iv) any confirmation patent or registration patent or patent of addition based on any such patents; (v) foreign counterparts and (vi) any other patents and patent applications that dominate the foregoing patents.
1.27 "Major European Country" shall mean each of France, Germany, Italy, Spain or the United Kingdom.
1.28 "Manufacture" shall mean all activities related to the manufacturing of a pharmaceutical product, or any ingredient thereof, including but not limited to test method development and stability testing, formulation, process development, manufacturing for use in non-clinical or clinical studies, manufacturing scale-up, manufacturing Licensed Compound or Licensed Product quality assurance/quality
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control development, quality control testing (including in-process release and stability testing), packaging, release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, and regulatory activities related to all of the foregoing.
1.29 "Marketing Authorization" shall mean, with respect to each country in the Territory, the receipt of all approvals from the relevant Regulatory Authority necessary to market and sell a Licensed Product in any country (including without limitation all applicable Price Approvals even if not legally required to sell Licensed Product in a country).
1.30 "NDA" shall mean a New Drug Application, Marketing Application Authorization, filing pursuant to Section 510(k) of the of the Food, Drug and Cosmetic Act, or similar application or submission for Marketing Authorization of a Licensed Product filed with a Regulatory Authority to obtain Marketing Authorization for a pharmaceutical or diagnostic product in that country or in that group of countries.
1.31 "Net Sales" shall mean with respect to a Licensed Product, the gross amount invoiced by Licensee (including a Licensee Affiliate) or any sublicensee thereof to unrelated Third Parties, excluding any sublicensee, for the Licensed Product in the Territory, less the following items consistent with U.S. Generally Accepted Accounting Principles consistently applied:
Disposition of Licensed Product for, or use of the Licensed Product in, clinical trials or other scientific testing, as free samples, or under compassionate use, patient assistance, or test marketing programs or other similar programs or studies where a Licensed Product is supplied without any charge shall not result in any Net Sales.
Such amounts shall be determined from the books and records of Licensee, affiliates of Licensee or any sublicensee maintained in accordance with U. S. Generally Accepted Accounting Principles consistently applied. Licensee further agrees in determining such amounts, it will use Licensee's then current standard procedures and methodology, including Licensee 's then current standard exchange rate methodology for the translation of foreign currency sales into U.S. Dollars.
In the event that the Licensed Product is sold as part of a Combination Product (where "Combination Product" means any pharmaceutical product which comprises the Licensed Product and other pharmaceutically active compound(s) and/or ingredients), the Net Sales of the Licensed Product, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales of the Combination Product (as defined in the standard Net Sales definition) by the fraction, A / (A+B) where A is the weighted average sale price of the Licensed Product when sold separately in finished form, and B is the weighted average sale price of the other product(s) sold separately in finished form.
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| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
In the event that the weighted average sale price of the Licensed Product can be determined but the weighted average sale price of the other product(s) cannot be determined, Net Sales for purposes of determining royalty payments shall be calculated by multiplying the Net Sales of the Combination Product by the fraction A / C where A is the weighted average sale price of the Licensed Product when sold separately in finished form and C is the weighted average sale price of the Combination Product.
In the event that the weighted average sale price of the other product(s) can be determined but the weighted average sale price of the Licensed Product cannot be determined, Net Sales for purposes of determining royalty payments shall be calculated by multiplying the Net Sales of the Combination Product by the following formula: one (1) minus (B / C) where B is the weighted average sale price of the other product(s) when sold separately in finished form and C is the weighted average sale price of the Combination Product.
In the event that the weighted average sale price of both the Licensed Product and the other product(s) in the Combination Product cannot be determined, the Parties shall negotiate in good faith and agree on another, commercially reasonable means of calculating Net Sales with respect to such Combination Product that fairly reflects the relative contribution, to the total market value of such Combination Product, of the Licensed Product in the Combination Product.
The weighted average sale price for a Licensed Product, other product(s), or Combination Product shall be calculated once each Calendar Year and such price shall be used during all applicable royalty reporting periods for the entire following Calendar Year. When determining the weighted average sale price of a Licensed Product, other product(s), or Combination Product, the weighted average sale price shall be calculated by dividing the sales dollars (translated into U.S. dollars) by the units of active ingredient sold during the twelve (12) months (or the number of months sold in a partial calendar year) of the preceding Calendar Year for the respective Licensed Product, other product(s), or Combination Product. In the initial Calendar Year, a forecasted weighted average sale price will be used for the Licensed Product, other product(s), or Combination Product. Any over or under payment due to a difference between forecasted and actual weighted average sale prices will be paid or credited in the first royalty payment of the following Calendar Year.
1.32 "Party" or "Parties" shall have the meaning given to such term in the preamble to this Agreement.
1.33 "Phase I Clinical Trial" shall mean a clinical trial of a Licensed Product in human patients at single and multiple dose levels with the primary purpose of determining safety, metabolism, and pharmacokinetic and pharmacodynamic properties of such Licensed Product, and which is consistent with 21 U.S. CFR § 312.21(a). For the avoidance of doubt, a Phase I Clinical Trial may include studies of the Licensed Compounds with chemotherapy agents to determine combination doses thereof.
1.34 "Phase II Clinical Trial" shall mean a clinical trial of a Licensed Product in human patients, the principal purposes of which are to make a preliminary determination that the Licensed Product is safe for its intended use, to determine its optimal dose, and to obtain sufficient information about such Licensed Product's efficacy to permit the design of Phase III Trials, and which is consistent with 21 U.S. CFR § 312.21(b).
1.35 "Phase III Clinical Trial" shall mean a clinical trial of a Licensed Product in human patients, which trial is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use, (b) to define warnings, precautions and adverse reactions that are associated with such Licensed
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| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
Product in the dosage range to be prescribed, (c) to be, either by itself or together with one or more other Clinical Trials having a comparable design and size, the final human Clinical Trial in support of Marketing Authorization of such Licensed Product, and (d) consistent with 21 U.S. CFR § 312.21(c). "Phase III Trial" shall not include a Phase IIIb Trial.
1.36 "Phase IIIb Clinical Trial" shall mean a clinical trial of a Licensed Product in human patients, which provides for product support (i.e., a clinical trial which is not required for receipt of initial Marketing Authorization but which may be useful in providing additional drug profile data or in seeking a label expansion) commenced before receipt of Marketing Authorization for the indication for which such trial is being conducted.
1.37 "Price Approval" shall mean the approval or determination by a Regulatory Authority for the pricing or pricing reimbursement for a pharmaceutical product.
1.38 "Proprietary Information" shall mean, as applicable, unpublished patent applications, Know-How and all other scientific, clinical, regulatory, marketing, financial and commercial information or data, whether communicated in writing, verbally or electronically, that is provided by one Party to the other Party in connection with this Agreement. All Know-How and other information disclosed by or on behalf of either Party pursuant to the Mutual Confidential Disclosure Agreement between Lilly and Licensee dated September 25, 2014 (the "Confidentiality Agreement") shall be deemed to be Party's Proprietary Information disclosed hereunder. The Parties agree that, effective as of the Effective Date, the Confidentiality Agreement shall be terminated, and superseded by this Agreement in its entirety.
1.39 "Regulatory Authority" shall mean any United States federal, state, or local government, or any foreign government, or political subdivision thereof, or any multinational organization or authority or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof), or any governmental arbitrator or arbitral body with responsibility for granting licenses or approvals, including Marketing Authorizations, necessary for the marketing and sale of the Licensed Product in any country.
1.40 "Related Party" shall mean each of Licensee, its Affiliates, and their respective sublicensees (which term does not include distributors), as applicable.
1.41 "Territory" shall mean the entire world.
1.42 "Third Party" shall mean an entity other than Lilly and its Affiliates and Licensee and its Related Parties.
1.43 "Valid Patent Claim" shall mean a claim of an issued and unexpired patent included within the Lilly Patent Rights, that has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and that has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer.
2.01 License Grant. Subject to the terms and conditions of this Agreement, Lilly hereby grants to Licensee and its Affiliates an exclusive, even as to Lilly and its Affiliates, transferrable as provided herein, royalty bearing license in the Territory in the Field, with the right to grant sublicenses (through
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| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
multiple tiers) as provided herein, under the Lilly Patent Rights and the Lilly Know-How to research, develop, make, have made, use, import, offer for sale and sell the Licensed Compounds and Licensed Products in the Field in the Territory during the Term.
2.02 No Non-Permitted Use. Licensee hereby covenants that it shall not, nor shall it cause or authorize, provide material support to or encourage any Affiliate or sublicensee to knowingly use or practice, directly or indirectly, any Lilly Know-How or Lilly Patent Rights for any purposes other than those expressly permitted by this Agreement.
2.03 No Other Licenses. Neither Party grants to the other Party any rights or licenses in or to any intellectual property, whether by implication, estoppel, or otherwise, other than the license rights that are expressly granted under this Agreement.
2.04 Sublicenses. Beginning after [**] of the Effective Date, Licensee may sublicense its rights under Section 2.01 to one or more Third Parties, to the extent necessary or useful to enable such Third Parties to research, develop, make, have made, use, import, offer for sale or sell Licensed Compound(s) or Licensed Product(s) in the Field in the Territory, and subject to the conditions of this Section 2.04.
2.05 Exclusivity. For a period of [**] years following the Effective Date, Lilly shall not, and shall ensure that none of its Affiliates will, either by itself or through collaboration with a Third Party, conduct human clinical studies, manufacture or commercialize anywhere in the Territory any product containing or comprising a selective Kappa Opioid Receptor Antagonist (such product, a "Competing Product"). In the event that Lilly is acquired by or merges with a Third Party that is engaged in active development or commercialization of a Competing Product at the closing of such acquisition or merger, then Lilly shall not be deemed to be in breach of this Section 2.05 with respect to any such Competing Product, and the terms of this Section 2.05 will not apply in any way to limit or restrict, by or on behalf
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of a Party or its Affiliates, the development, use, manufacture, marketing, sale, promotion or commercialization of any such Competing Product that as of the date of closing of such acquisition or merger was controlled by such Third Party acquiror.
2.06 Third Party Licenses. During the Term, if Lilly obtains a license for any Patent rights or Know-how from a Third Party that would be included within the scope of the Lilly Patent Rights or Lilly Know-How for which payments would be due to such Third Party on account of such license, then Lilly, provided it has the legal right to do so, shall notify Licensee, identifying the relevant patent rights or Know-how. If Licensee provides Lilly with written notice in which (a) Licensee consents to including such patent rights or Know-how as Lilly Patent Rights or Lilly Know-How under this Agreement and (b) Licensee agrees to be responsible for (i) all royalty payments due on account of a Licensed Product and all other current and future payments specific to one or more License Products, and (ii) its pro rata share of current and future payments which are reasonably applicable to both Licensed Products and other products or services offered by Lilly or its licensees of such patents rights and/or Know-How, in each of (i) and (ii) due to such Third Party on account of the use of such patent rights or Know-how in connection with the use, sale, offer for sale, importation, and development, manufacture or commercialization of any Licensed Product in the Field ("Third Party License Expenses"), then, if legally permissible, such patent rights or Know-how, as applicable, will be deemed Lilly Patent Rights or Lilly Know-How hereunder, as applicable. Licensee shall have the discretion to terminate its license under the Third Party License at any time and upon thirty (30) days' written notice to Lilly provided that Licensee shall be responsible for all Third Party License Expenses due and owing prior to the effective date of such termination and shall be responsible for a proportional share of any subsequent liability to the extent directly resulting from such termination.
2.07 Section 365(n) of the Bankruptcy Code. All rights and licenses granted under or pursuant to any section of this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to "intellectual property" as defined under Section 101(35A) of the Bankruptcy Code. Each Party shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code or equivalent legislation in any other jurisdiction. Upon the bankruptcy of either Party, the other Party shall further be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property, and such, if not already in its possession, shall be promptly delivered to such other Party, unless the Party in bankruptcy elects to continue, and continues, to perform all of its obligations under this Agreement.
ARTICLE III — DEVELOPMENT AND COMMERCIALIZATION
3.01 Overview. As of the Effective Date, Licensee shall be solely responsible for the Development and Commercialization, including all costs thereof, of the Licensed Product in the Field in the Territory. Licensee shall perform all of its Development activities consistent with the IND for the Licensed Product and in accordance with all applicable laws, rules and regulations.
3.02 Development and Commercialization Plans.
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3.03 Development Reports. Licensee shall submit to Lilly, every twelve (12) months after the Effective Date until the First Commercial Sale, a written report in reasonably sufficient detail describing the research, development and manufacturing progress of Licensee or a Related Party for Licensed Compounds and/or Licensed Products during the previous twelve (12) month period, as well as a list of any sublicensees granted during the preceding twelve (12) months. All such reports shall be considered Proprietary Information of Licensee.
3.04 Commercialization. Licensee shall provide Lilly with the anticipated commercial launch of each Licensed Product in a country for which NDA (or foreign equivalent) and Marketing Authorization has been obtained.
3.05 Commercialization Reports. Licensee shall submit to Lilly, every twelve (12) months after First Commercial Sale of a Licensed Product, a written report in reasonably sufficient detail describing the general commercialization progress of Licensee or a Related Party for Licensed Compounds and/or Licensed Products during the previous twelve (12) month period, including a list all ongoing Commercialization Studies and the status of such studies in the United States, the Major European Countries and Japan.
3.06 [**]
3.07 Subcontracting. Consistent with the provisions of this Agreement, Licensee may perform any activities in support of its development and commercialization of Licensed Compounds and Licensed Products through subcontracting to its Affiliates or Third Parties, including Third Party subcontractors, contract service organizations, and academic or government collaborators.
ARTICLE IV — TRANSFER OF LILLY KNOW-HOW & EXISTING STUDIES
4.01 Materials and Regulatory Filings Transfer.
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4.02 Pharmacovigilance and Product Complaints.
4.03 Existing Studies. Without limiting Section 11.02, as between the Parties, Cerecor shall assume all responsibility going forward for studies by Third Parties that exist as of the Effective Date
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("Existing Studies"). Cerecor shall be responsible for all future conduct of the Existing Studies, including additional drug product supplies and drug product stability studies, and all requirements of Applicable Law, including regulatory requirements such as recording, investigating, summarizing, notifying, reporting and reviewing all AEs and other reportable occurrences and inquiries associated with Products in accordance with Applicable Laws and shall adhere to all requirements of Applicable Laws related to the reporting and investigation of AEs and other reportable occurrences and inquiries.
4.04 Reasonable Cooperation. From time to time during the Term, and without limiting Lilly's obligations hereunder, at Licensee's reasonable request, Lilly shall reasonably cooperate with Licensee and shall (a) furnish such further information in Lilly's possession not previously furnished, but otherwise required to be furnished by Lilly to Licensee pursuant to this Agreement, (b) execute and deliver, or cause to be executed and delivered, such other instruments of conveyance and transfer, certificates, deeds or other documents, (c) use reasonable efforts to deliver any additional materials deliverable under this Agreement not previously transferred to Licensee, (d) use reasonable efforts to require its agents and consultants to be reasonably available to Licensee (or its authorized attorneys, agents, or representatives) to the extent reasonably necessary to enable Licensee to help facilitate document transfer, and (e) take, or cause to be taken, all other reasonable actions as promptly as practicable as Licensee may reasonably request in order to comply with applicable Laws or to effectively consummate the transfer, assignment and grant of license as contemplated by this Agreement. Licensee shall compensate Lilly for reasonable expenses and costs, for any activities undertaken by Lilly at Licensee's request pursuant to this Section 4.04, unless such activities should have been taken as required under this Agreement.
5.01 Generally. Licensee shall use Commercially Reasonable Efforts to Develop and Commercialize (following Regulatory Approval) at least one Licensed Compound or Licensed Product in the Field in the United States, a Major European Country or Japan, whether alone or with or through one (1) or more Related Party.
5.02 Understanding Regarding Diligence. It is understood and agreed that the obligation of Licensee to use Commercially Reasonable Efforts with respect to the development of any specific Licensed Compound or Licensed Product under Section 5.01 of this Agreement is expressly subject to the continuing absence of any materially adverse condition or event relating to the safety or efficacy of the Licensed Compound or Licensed Product, and the specific tasks that Licensee shall undertake to develop or market any such Licensed Compound or Licensed Product, in compliance with such Commercially Reasonable Efforts obligation, shall be modified or delayed as may be required in Licensee's reasonable opinion in order to address any such materially adverse condition or event so long as any such condition or event exists.
6.01 Manufacturing Responsibility. After the Effective Date, Licensee will be responsible for the manufacturing and any ongoing or future stability studies related to the Licensed Compound and Licensed Product for use by Licensee, its Affiliates and its sublicensees in the Field in the Territory.
6.02 Transfer of Know-How. Lilly shall, pursuant to Section 4.01(a), transfer to Licensee, or a Third Party manufacturer designated by Licensee, all Lilly Know-How that is reasonably necessary or
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useful to enable Licensee or its Third Party manufacturer to Manufacture the Licensed Compound or Licensed Product. In addition, as reasonably requested by Licensee, during a period of twelve (12) months following the Effective Date, Lilly shall make Lilly's personnel and/or consultants available to Licensee, at no additional cost or expense to Licensee, to provide reasonable technical support and assistance for up to [**] hours. After such transfer period, Lilly may provide, upon reasonable request by Licensee, technical consultation and Licensee shall reimburse Lilly for the cost of Lilly's out-of-pocket expenses and such time or hours at an FTE rate of [**] per hour for all Lilly personnel consultation hours. Lilly shall act reasonably in considering any request by Licensee for such consultation.
ARTICLE VII — PAYMENTS; ROYALTIES AND REPORTS
7.01 Consideration for License. In consideration for the license granted hereunder, Licensee shall pay to Lilly a non-refundable, non-creditable, upfront payment of one million U.S. dollars ($1,000,000.00), seven hundred fifty thousand U.S. dollars ($750,000.00) of which shall be due within thirty (30) days of the Effective Date of this Agreement, and the remaining balance of two hundred fifty thousand U.S. dollars ($250,000.00) payable within thirty (30) days of completion of the final study report for the 9-month chronic toxicology study to be conducted by Licensee in non-human primates.
7.02 Milestone Payments.
| Milestone Event |
Amount Due | |
|---|---|---|
The earlier of: (i) filing and acceptance of an NDA or equivalent for a Licensed Product in the United States |
$[**] | |
NDA approval for a Licensed Product in the United States |
$[**] | |
NDA approval or equivalent for a Licensed Product by the European Medicines Agency or in any Major European Country |
$[**] | |
NDA approval or equivalent for a Licensed Product in Japan |
$[**] | |
First Commercial Sale of a Licensed Product in the United States |
$[**] | |
First Commercial Sale of a Licensed Product in a Major European Country |
$[**] | |
First Commercial Sale of a Licensed Product in Japan |
$[**] |
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7.03 Royalties.
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7.04 Reports; Payment of Royalty; Payment Exchange Rate and Currency Conversions.
7.05 Maintenance of Records; Audits.
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7.06 Income Tax. If laws, rules, or regulations require the withholding of income tax or other taxes imposed upon payments set forth in this Article VII, Licensee will notify Lilly in writing of such payment or withholding requirements prior to making the payment and provide such assistance to Lilly, including the provision of such documentation as may be required by a tax authority, as may be reasonably necessary to claim an exemption from or reduction of such Taxes. In the event Licensee withholds taxes under this section and remits such taxes to the appropriate tax authority, Licensee will furnish Lilly with proof of payment of such taxes promptly following payment thereof. If taxes are paid to a tax authority, Licensee will provide Lilly all such assistance as is reasonably required to obtain a refund of taxes withheld, or obtain a credit with respect to Taxes paid.
8.01 Ownership of Inventions. As between the Parties, Licensee shall own the entire right, title and interest in and to any and all Know-How discovered, created, identified or made solely by it and its Related Parties and their respective employees, agents or independent contractors in the course of performing or exercising its rights under this Agreement, and all intellectual property rights in any of the foregoing. Inventorship shall be determined in accordance with U.S. patent laws.
8.02 Prosecution and Maintenance of Patents. Licensee shall have the first right, but not the obligation, at its expense, to prepare, file, prosecute and maintain Lilly Patent Rights in the Territory, on its own or through its Affiliate, or through outside counsel or Third Party contractor. Licensee will provide Lilly with copies of any substantive papers filed with or received by a patent office related to the maintenance of such patent filings. Licensee shall provide Lilly with drafts of any material filings in a reasonable amount of time in advance of the anticipated filing date and shall consider Lilly's reasonable comments thereto in good faith. The abandonment of any of the Lilly Patent Rights shall be
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governed by Section 8.07. Promptly following the Effective Date, Lilly shall transfer the existing, complete patent files for all applicable patents and patent applications to Licensee, shall file all documents necessary to transfer correspondence with the U.S. Patent and Trademark Office and other applicable patent authorities to Licensee and shall give Licensee's designated patent counsel power of attorney thereto. Lilly shall cooperate with Licensee in the transfer of all prosecution and maintenance responsibilities relating to the Lilly Patent Rights. For clarity, after such transfer, Lilly will cooperate, but will not be responsible for further maintenance and annuity payments.
8.03 Patent Term Restoration. Licensee shall have the first right, but not the obligation, with respect to election to obtain patent term restoration or supplemental protection certificates or their equivalents in any country in the Territory where applicable to Lilly Patent Rights. Lilly agrees to reasonably assist Licensee as needed with the filing and prosecuting of any such application for patent term restoration or supplemental protection certificates or their equivalents. To the extent Licensee has elected to seek such patent term restoration or supplemental protection certificates or equivalents, Licensee (a) shall pay all costs associated with the preparation, filing and prosecuting of any such application for patent term restoration or supplemental protection certificates or their equivalents hereunder, (b) agrees to consult with Lilly as to the preparation, filing, prosecution of such application for patent term restoration or supplemental protection certificates or their equivalents reasonably prior to any deadline or action, and (c) shall provide Lilly with drafts of any material filings in a reasonable amount of time in advance of the anticipated filing date and shall consider in good faith any comments of Lilly.
8.04 Interference, Derivation, Opposition, Reissue Reexamination and Post Grant Review Proceedings. Any Party shall, within ten (10) business days of learning of any request for, or filing or declaration of, any interference, derivation, opposition, reexamination, or post grant review (or similar administrative proceedings) relating to Lilly Patent Rights, inform the other Party of such event. Licensee shall have the first right, but not the obligation, to determine a course of action with respect to any such proceeding and to control such proceeding. Lilly shall have the right to review any submission to be made in connection with such proceeding. In connection with any such interference, derivation, opposition, reissue, reexamination, or post grant review proceeding (or similar administrative proceedings) or correction relating to Lilly Patent Rights, Lilly will cooperate fully and will provide Licensee with any information or assistance that Licensee may reasonably request. Licensee shall keep Lilly informed of developments in any such action or proceeding, including, to the extent permissible by law, consultation and approval of any settlement, the status of any settlement negotiations and the terms of any offer related thereto. To the extent Licensee has elected to control the foregoing, Licensee shall bear the expense of such proceeding or action with respect to the Lilly Patent Rights.
8.05 Enforcement and Defense. In the event that either Licensee or Lilly becomes aware of any alleged, threatened or actual commercially material infringement of a Lilly Patent Right in a country in the Territory, or judicial challenge to the validity of a Lilly Patent Right in a country in the Territory, it will notify the other Party in writing to that effect within a reasonable time period.
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Patent Rights or Licensee Patent Rights claiming or covering Licensed Compounds or Licensed Products without the prior written consent of Licensee and Lilly, such consent shall not be unreasonably withheld.
8.06 Third Party Infringement Suit. In the event that a Third Party sues Licensee alleging that Licensee's, its Affiliates' or its sublicensees' making, having made, importing, exporting or using Licensed Compound or distributing, marketing, promoting, offering for sale or selling Licensed Product infringes or will infringe a claim of a Third Party patent that specifically covers the Licensed Compound or its manufacture, then Licensee may elect to defend such suit.
8.07 Abandonment. In the event that Licensee determines not to file, maintain or continue prosecution of any patent or patent application within the Lilly Patent Rights, Licensee shall provide Lilly written notice thereof at least thirty (30) days before the applicable deadline. Upon receipt of such notice, Lilly shall have the right, at its expense, to assume responsibility for filing, prosecuting, and maintaining such patents and patent applications. If Lilly decides to assume such responsibility, in its sole discretion, it shall so notify Licensee in writing.
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ARTICLE IX — CONFIDENTIALITY AND PUBLICATION
9.01 Confidentiality.
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9.02 Breach of Confidentiality. The Parties agree that the disclosure of the Disclosing Party's Proprietary Information in violation of this Agreement may cause the Disclosing Party irreparable harm and that any breach or threatened breach of this Agreement by the Receiving Party entitles disclosing Party to seek injunctive relief, in addition to any other legal or equitable remedies available to it, in any court of competent jurisdiction. For clarity, such disputes shall not be subject to Article XIII.
9.03 No Publicity. A Party may not use the name of the other Party in any publicity or advertising and may not issue a press release or otherwise publicize or disclose any information related to the existence of this Agreement or the terms or conditions herein, except (a) on the advice of its counsel as required by law (e.g., any Securities and Exchange Commission filings and disclosures) and provided the Party who will be disclosing such information has consulted with the other Party to the extent feasible prior to such disclosure with respect to the substance of the disclosure; or (b) as consented to in advance by the other Party in writing. Notwithstanding the foregoing, Licensee shall have the right without obtaining Lilly's consent to make public announcements concerning the Development or Commercialization of the Licensed Product in the Field in the Territory under this Agreement, such as announcing the commencement of any clinical trial for the Licensed Product, the publication of data and results, the filing of regulatory filings for the Licensed Product and the achievement of Marketing Authorization of the Licensed Product. The Parties have agreed on a form of initial press release that may be used by either Party on an ongoing basis to describe this Agreement that is attached hereto as Attachment 9.03. Licensee shall provide Lilly with reasonable advance written notice of any press release or other public disclosure of the results of any of its work on Licensed Compound or Licensed Product under this Agreement.
9.04 Scientific Publications. Each Party recognizes the mutual interest in obtaining valid patent protection and in protecting business interests and trade secret information. Consequently, except for disclosures permitted pursuant to Section 9.01 and Section 9.03 of this Agreement, in the event that a Party wishes to make a publication containing any Lilly Know-How or subject of Lilly Patent Rights, such Party shall deliver to the other Party a copy of the proposed written publication at least thirty (30) days prior to submission for publication. The Parties shall have the right to propose modifications to or delay of the publication for patent reasons or trade secrets. If a reviewing Party requests a delay
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for patent reasons, the other Party shall delay submission for a period of up to forty-five (45) days to enable patent applications protecting each Party's rights in such information to be filed in accordance with Article VIII of this Agreement. Upon expiration of such delay, the Party seeking to publish shall be free to proceed with the publication. If a Party requests modifications to the publication, the Party seeking to publish shall edit such publication to prevent disclosure of trade secret or Proprietary Information prior to submission of the publication.
9.05 Terms of Agreement. Neither Party nor its Affiliates shall disclose any terms or conditions of this Agreement to any Third Party without the prior consent of the other Party, except as follows: a Party and its Affiliates may disclose the terms or conditions of this Agreement (but not any other Proprietary Information, which may be disclosed only as described elsewhere in this Article IX), (a) on a need-to-know basis to its legal and financial advisors to the extent such disclosure is reasonably necessary, provided that such advisors are subject to confidentiality with regard to such information under an agreement or ethical obligation; (b) to a Third Party or Related Party in connection with (i) a financing (or proposed financing) or an equity investment (or proposed investment) in such Party or its Affiliates, including to its shareholders and prospective shareholders, (ii) the granting of a sublicense pursuant to Section 2.04 or entry into any agreement with respect to the development, manufacture or commercialization of a Licensed Product, (iii) a merger, consolidation or similar transaction by such Party or its Affiliates, (iv) the sale of all or substantially all of the assets of such Party or its Affiliates to which this Agreement relates, or (v) in connection with a securitization, provided that such Third Party executes a non-use and non-disclosure agreement with confidentiality and non-use obligations similar to those contained in this Agreement; (c) to the United States Securities and Exchange Commission or any other securities exchange or governmental entity, including as required to make an initial or subsequent public offering, or (d) as otherwise required by law or regulation, provided that in the case of (c) and (d) the disclosing Party shall (x) if practicable, provide the other Party with reasonable advance notice of and an opportunity to comment on any such required disclosure, (y) if requested by such other Party, seek, or cooperate with such Party's efforts to obtain, confidential treatment or a protective order with respect to any such disclosure to the extent available at such other Party's expense, and (z) use good faith efforts to incorporate the comments of such other Party in any such disclosure or request for confidential treatment or protective order.
ARTICLE X — REPRESENTATIONS AND WARRANTIES
10.01 Representations and Warranties of Each Party. Each of Lilly and Licensee hereby represents, warrants and covenants to the other Party hereto as follows:
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10.02 Lilly's Representations. Lilly hereby represents, warrants and covenants to Licensee that as of the Effective Date:
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10.03 Licensee's Representations. Licensee hereby represents and warrants as of the Effective Date, and covenants during the Term, to Lilly that, it will not knowingly use in any capacity, in connection with any services to be performed under this Agreement, any individual who has been debarred pursuant to the United States Food, Drug and Cosmetic Act. Licensee represents and warrants that there are no pending or, to Licensee's knowledge, threatened judicial, administrative or arbitral actions, claims, suits or proceedings pending as of the date hereof against Licensee which, to Licensee's knowledge, either individually or together with any other, would have a material adverse effect on the ability of Licensee to perform its obligations under this Agreement or any agreement or instrument contemplated hereby.
10.04 No Inconsistent Agreements. Neither Party has in effect, and after the Effective Date neither Party shall enter into, any oral or written agreement or arrangement that would be inconsistent with its obligations under this Agreement.
10.05 Representation by Legal Counsel. Each Party hereto represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting of this Agreement. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption shall exist or be implied against the Party that drafted such terms and provisions.
10.06 Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE X, THE LICENSED COMPOUND, LICENSED PRODUCT, LILLY PATENT RIGHTS, LILLY KNOW-HOW, LICENSEE PATENT RIGHTS AND LICENSEE KNOW-HOW ARE PROVIDED "AS IS" AND WITHOUT ANY REPRESENTATION OR WARRANTY OF ANY KIND, WHETHER EXPRESS, IMPLIED OR STATUTORY, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.
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ARTICLE XI — INDEMNIFICATION AND LIMITATION ON LIABILITY
11.01 Indemnification by Licensee. Licensee shall indemnify, defend and hold harmless Lilly and its Affiliates, and each of its and their respective employees, officers, directors and agents (each, a "Lilly Indemnified Party") from and against any and all liability, loss, damage, cost, and expense (including reasonable attorneys' fees), (collectively, a "Liability") that a Lilly Indemnified Party may incur, suffer or be required to pay resulting from or arising out of a suit or action brought by a Third Party with respect to (i) the Development, Manufacture, Commercialization, promotion, distribution, use, marketing, sale or other disposition of the Licensed Compound or Licensed Product by Licensee, its Affiliates or sublicensees, (ii) any breach by Licensee of any of its representations, warranties and covenants contained in Article X herein or any material breach of its obligations under this Agreement, and (iii) the negligence and/or willful misconduct of Licensee, its Affiliates or sublicensees with respect to its obligations under this Agreement. Notwithstanding the foregoing, Licensee shall have no obligation under this Agreement to indemnify, defend or hold harmless any Lilly Indemnified Party with respect to any Liabilities to the extent that they result from the negligence or willful misconduct of Lilly, Lilly Indemnified Party or any of their respective employees, officers, directors or agents or that result from Lilly's breach of its obligations under this Agreement.
11.02 Indemnification by Lilly. Lilly shall indemnify, defend and hold harmless Licensee and its Affiliates, and each of its and their respective employees, officers, directors and agents (each, a "Licensee Indemnified Party") from and against any Liability that a Licensee Indemnified Party may incur, suffer or be required to pay resulting from or arising in connection with a suit or action brought by a Third Party with respect to (i) any breach by Lilly of any of its representations, warranties and covenants contained in Sections 10.01, 10.02 and 10.04 herein or any material breach of its obligations (ii) the negligence and/or willful misconduct of Lilly, and (iii) the Development, Manufacture, use or other disposition of the Licensed Compound or Licensed Product by Lilly or its Affiliates prior to the Effective Date, including, with respect to the Existing Studies. Notwithstanding the foregoing, Lilly shall have no obligation under this Agreement to indemnify, defend or hold harmless any Licensee Indemnified Party with respect to any Liabilities to the extent that they result from the negligence or willful misconduct of Licensee, Licensee Indemnified Party or any of their respective employees, officers, directors or agents or that result from Licensee's breach of its obligations under this Agreement.
11.03 Conditions to Indemnification. The obligations of the indemnifying Party under Sections 11.01 and 11.02 are conditioned upon the delivery of written notice to the indemnifying Party of any potential Liability promptly after the indemnified Party becomes aware of such potential Liability. The indemnifying Party shall have the right to assume the defense of any suit or claim related to the Liability if it has assumed responsibility for the suit or claim in writing; however, if in the reasonable judgment of the indemnified Party, such suit or claim involves an issue or matter that could have a materially adverse effect on the business operations or assets of the indemnified Party, the indemnified Party may retain control of the defense or settlement thereof by providing written notice of such effect to the indemnifying Party, but in no event shall such action or notice be construed as a waiver of any indemnification rights that the indemnified Party may have at law or in equity. If the indemnifying Party defends the suit or claim, the indemnified Party may participate in (but not control) the defense thereof at its sole cost and expense. The foregoing notwithstanding, the Parties acknowledge and agree that failure of the indemnified Party to promptly notify the indemnifying Party of a potential Liability shall
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not constitute a waiver of, or result in the loss of, such Party's right to indemnification under Section 11.01 or 11.02, as appropriate, except to the extent that the indemnifying Party's rights, and/or its ability to defend against such Liability, are materially prejudiced by such failure to notify.
11.04 Settlements. Neither Party may settle a claim or action related to a Liability without the consent of the other Party, and such consent shall not be unreasonably withheld, if such settlement would impose any monetary obligation on the other Party or require the other Party to submit to an injunction or otherwise limit the other Party's rights under this Agreement. Any payment made by a Party to settle any such claim or action shall be at its own cost and expense.
11.05 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, INCIDENTAL, PUNITIVE, CONSEQUENTIAL OR INDIRECT DAMAGES OR LOSS OF PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 11.05 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 11.01 OR 11.02, OR DAMAGES AVAILABLE FOR A PARTY'S BREACH OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE IX OR EXCLUSIVITY OBLIGATIONS IN SECTION 2.05.
11.06 Insurance. Licensee shall procure and maintain insurance, including product liability insurance, adequate to cover its obligations hereunder and which are consistent with normal business practices of prudent companies similarly situated at all times during which any Licensed Product is being clinically tested in human subjects or commercially distributed or sold by or on behalf of Licensee. It is understood that such insurance shall not be construed to create a limit of Licensee's liability with respect to its indemnification obligations under this Article 11. Licensee shall provide Lilly with written evidence of such insurance upon request. Licensee shall provide Lilly with written notice at least thirty (30) days prior to the cancellation, non renewal or material change in such insurance or self insurance which materially adversely affects the rights of Lilly hereunder.
ARTICLE XII — TERM AND TERMINATION
12.01 Term and Expiration. This Agreement shall be effective as of the Effective Date and unless terminated earlier by mutual written agreement of the Parties or pursuant to Sections 12.02 or 12.03 below, the term of this Agreement shall continue in effect on a country-by-country and product-by-product basis until the expiration of Licensee's obligation to pay royalties under Article VII herein (the "Term"). Upon expiration of this Agreement in its entirety, Licensee's license pursuant to Section 2.01 shall become a fully paid-up, royalty-free, irrevocable, perpetual non-exclusive license.
12.02 Termination by Licensee. Notwithstanding anything contained herein to the contrary, Licensee shall have the unilateral right to terminate this Agreement in its entirety without cause at any time by giving ninety (90) days advance written notice to Lilly. In the event of such termination, the rights and obligations hereunder shall terminate; provided, however, that any payment obligations due and owing as of the termination date shall continue.
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12.03 Termination for Cause.
12.04 Effect of Termination on License. In the event this Agreement is terminated in accordance with this Agreement, the rights and license granted to Licensee and its Affiliates under Section 2.01 of this Agreement shall terminate and all rights to the Licensed Compound and Licensed Product granted under this Agreement shall revert to Lilly, provided that all sublicenses granted under Section 2.05 shall survive to the extent so provided herein.
12.05 Effect of Termination Generally; Survival. Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination, and the
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provisions of [Article 1 (Definitions), Article IX (Confidentiality), Article XI (Indemnification and Limitation on Liability), Article XIII (Dispute Resolution), Article XIV (Miscellaneous) and Section 8.01, Section 10.06, Section 10.07, Section 12.01, Section 12.02(b), Section 12.03(b), Section 12.04, Section 12.05 and Section 12.06][NTD: To be finalized prior to execution.] shall survive the expiration or termination of this Agreement. Any expiration or early termination of this Agreement shall be without prejudice to the rights of either Party against the other accrued or accruing under this Agreement prior to termination, including the obligation to pay royalties for Licensed Product sold prior to such termination.
12.06 Licensed Product Reversion. Upon termination of this Agreement in its entirety by Lilly for any reason or by Licensee pursuant to Section 12.02, at Lilly's option and upon Lilly's written request, and at Licensee's expense, the following provisions shall apply:
12.07 Termination in Part. In the event that this Agreement is terminated in part with respect to an individual Licensed Product, the terms of Sections 12.04 through 12.06 shall apply accordingly to such terminated Licensed Product, as opposed to termination of the Agreement as a whole.
12.08 Return of Proprietary Information. Not later than thirty days (30) days after the termination of this Agreement in its entirety, each receiving Party shall, at the disclosing Party's discretion, either destroy or return or cause to be returned to the disclosing Party, all Proprietary Information of the disclosing Party in tangible form received from the disclosing Party and any other documents containing the disclosing Party's Proprietary Information, and all copies thereof, including those in the possession of the receiving Party's Agents pursuant to Section 9.01(d), except that the receiving Party may
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retain one (1) copy of the disclosing Party's Proprietary Information in its confidential files in a secure location solely for the purposes of (i) determining its obligations hereunder, (ii) complying with any applicable regulatory requirements, or (iii) defending against any product liability claim.
ARTICLE XIII — DISPUTE RESOLUTION
13.01 Informal Discussions. Except as otherwise provided herein, in the event of any controversy or claim arising out of or relating to this Agreement, or the rights or obligations of the Parties hereunder, or the relationship between the Parties with respect to the Licensed Compound or Licensed Product, the Parties shall first try to settle their differences amicably between themselves. Either Party may initiate such informal dispute resolution by sending written notice of the dispute to the other Party, and within thirty (30) days after such notice appropriate representatives of the Parties shall meet for attempted resolution by good faith negotiations. If such representatives are unable to resolve promptly such disputed matter within the said thirty (30) days, either Party may refer the matter by written notice to the other under Section 14.07 to the [**], or designee, and the Chief Executive Officer of Licensee, or designee, for discussion and resolution. If such individuals or their designees are unable to resolve such dispute within sixty (60) days of such written notice, either Party may initiate arbitration proceedings in accordance with the provisions of this Article XIII.
13.02 Arbitration. All disputes arising out of or relating to this Agreement, or the rights or obligations of the Parties hereunder, or relating in any way to the relationship between the Parties with respect to the Licensed Compound or Licensed Product, shall be finally and exclusively settled by arbitration by a panel of three (3) arbitrators, provided such dispute is not an "Excluded Claim". As used in this Section 13.02, the phrase "Excluded Claim" shall mean a dispute, controversy or claim that concerns (a) the validity or infringement of a patent, trademark or copyright; (b) misappropriation of trade secrets; or (c) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory.
30
| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
13.03 Injunctive Relief. By agreeing to arbitration, the Parties do not intend to deprive any competent court of such court's jurisdiction to issue a pre-arbitral injunction, pre-arbitral attachment or other order in aid of the arbitration proceedings and the enforcement of any award or judgment. Without prejudice to such provisional remedies in aid of arbitration as may be available under the jurisdiction of a national court, the court of arbitration shall have full authority to grant provisional remedies and to award damages for failure of any Party to respect the court of arbitration's order to that effect.
13.04 Expenses of Arbitration and Expert Determination. Each Party shall bear its own attorneys' fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the arbitrators; provided, however, that the arbitrators shall be authorized to determine whether a Party is the prevailing Party, and if so, to award to that prevailing Party reimbursement for its reasonable attorneys' fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges and travel expenses). Absent the filing of an application to correct or vacate the arbitration award as permitted by applicable law, each Party shall fully perform and satisfy the arbitration award within fifteen (15) days of the service of the award.
31
| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
14.01 Assignment/Change of Control.
14.02 Governing Law. This Agreement shall be governed, interpreted and construed in accordance with the laws of the State of Delaware, United States of America without giving effect to its conflict of law principles, and the national patent laws relevant to the patent at issue. Subject to the terms of this Agreement, all disputes under this Agreement shall be governed by binding arbitration pursuant to the mechanism set forth in Article XIII herein, provided, however, that notwithstanding anything to the contrary in this Agreement, nothing herein shall prohibit a Party from bringing a dispute involving a an actual or alleged breach of confidentiality or an actual or alleged misappropriation or infringement of its intellectual property rights in a court of competent jurisdiction.
14.03 Waiver. Any delay or failure in enforcing a Party's rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such Party's rights to the future enforcement of its rights under this Agreement, nor operate to bar the exercise or enforcement thereof at any time or times thereafter, excepting only as to an express written and signed waiver as to a particular matter for a particular period of time.
14.04 Independent Relationship. Nothing herein contained shall be deemed to create an employment, agency, joint venture or partnership relationship between the Parties hereto or any of their agents or employees, or any other legal arrangement that would impose liability upon one Party for the act or failure to act of the other Party. Neither Party shall have any power to enter into any contracts or commitments or to incur any liabilities in the name of, or on behalf of, the other Party, or to bind the other Party in any respect whatsoever.
32
| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
14.05 Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States of America that may be imposed upon or related to Lilly or Licensee from time to time by the government of the United States of America. Furthermore, Licensee agrees that it will not export, directly or indirectly, any technical information acquired from Lilly under this Agreement or any Licensed Products using such technical information to any country for which the United States government or any agency thereof at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the Department of Commerce or other agency of the United States government when required by an applicable statute or regulation.
14.06 Entire Agreement; Amendment. This Agreement, including the Schedules hereto and thereto, sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto and supersedes and terminates all prior agreements and understandings between the Parties with regard to the subject matter of this Agreement in the Territory, including the Confidentiality Agreement. There are no other covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth herein and therein. No subsequent alteration, amendment, change, waiver or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.
14.07 Notices. All notices which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile or a PDF document sent by electronic mail (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:
| if to Licensee, to: | Cerecor Inc. 400 East Pratt Street Baltimore, MD 21202 Attn : [**] [**] |
|
With copy to (which copy shall not constitute notice): |
[**], Esq. Cooley LLP One Freedom Square Reston Town Center 11951 Freedom Drive Reston, VA 20190-5656 Ph. [**] [**] |
|
if to Lilly, to: |
Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285 Attention: [**] Fax: [**] |
33
| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
Any such notice shall be deemed to have been received on the earlier of the date actually received or the date five (5) days after the same was posted or sent. Either Party may change its address or its facsimile number by giving the other Party written notice, delivered in accordance with this Section 14.07.
14.08 Force Majeure. Failure of any Party to perform its obligations under this Agreement (except the obligation to make payments when properly due) shall not subject such Party to any liability or place them in breach of any term or condition of this Agreement to the other Party if such failure is due to any cause beyond the reasonable control of such non-performing Party ("Force Majeure"), unless conclusive evidence to the contrary is provided. Causes of non-performance constituting Force Majeure shall include, without limitation, acts of God, fire, explosion, flood, drought, war, riot, sabotage, embargo, strikes or other labor trouble, failure in whole or in part of suppliers to deliver on schedule materials, equipment or machinery, interruption of or delay in transportation, a national health emergency or compliance with any order or regulation of any government entity acting with color of right. The Party affected shall promptly notify the other Party of the condition constituting Force Majeure as defined herein and shall exert reasonable efforts to eliminate, cure and overcome any such causes and to resume performance of its obligations with all possible speed; provided that nothing herein shall obligate a Party to settle on terms unsatisfactory to such Party any strike, lockout or other labor difficulty, any investigation or other proceeding by any public authority or any litigation by any Third Party. If a condition constituting Force Majeure as defined herein exists for more than ninety (90) consecutive days, the Parties shall meet to negotiate a mutually satisfactory resolution to the problem, if practicable. If the Parties cannot in good faith reach a satisfactory resolution to the problem within sixty (60) days of meeting, the matter shall be handled pursuant to the dispute resolution provisions of Article XIII herein.
14.09 Severability. If any provision of this Agreement is declared illegal, invalid or unenforceable by a court having competent jurisdiction, it is mutually agreed that this Agreement shall continue in accordance with its terms except for the part declared invalid or unenforceable by order of such court, provided, however, that in the event that the terms and conditions of this Agreement are materially altered, the Parties will, in good faith, renegotiate the terms and conditions of this Agreement to reasonably substitute such invalid or unenforceable provisions in light of the intent of this Agreement.
14.10 Extension to Affiliates. In each case where an Affiliate of Licensee has an obligation pursuant to this Agreement or performs an obligation pursuant to this Agreement, Licensee shall cause and compel such Affiliate to perform such obligation and comply with the terms of this Agreement. For the purposes of this Agreement, the Licensee shall be responsible for the contractual obligations of Affiliates. Licensee shall remain fully liable for any acts or omissions of its Affiliates.
14.11 Counterpart. This Agreement shall become binding when any one or more counterparts of it, individually or taken together, shall bear the signatures of each of the Parties hereto. This Agreement may be executed in any number of counterparts, each of which shall be an original as against either Party whose signature appears thereon, but all of which taken together shall constitute but one and the same instrument.
14.12 Captions. The captions of this Agreement are solely for the convenience of reference and shall not affect its interpretation.
34
| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
14.13 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
14.14 Signatures. For purposes of this Agreement, signatures sent by facsimile or PDF shall also constitute originals.
[Signature Page Follows.]
35
| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
IN WITNESS WHEREOF, this Agreement has been executed by the duly authorized representatives of the Parties.
| ELI LILLY AND COMPANY | CERECOR INC. | |||||
By: |
/s/ JAN M. LUNDBERG |
By: |
/s/ BLAKE PATERSON |
|||
Title: |
Executive VP, Science & Technology President, Lilly Research Laboratories |
Title: |
President + CFO |
|||
Date: |
2/6/15 |
Date: |
2/17/15 |
|||
36
| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
Schedule 1.23
Licensed Compound (LY2456302)
Material Transfer
API
(GMP)
Lot#
|
DOM | Re-Test | Quantity (g) | |||
|---|---|---|---|---|---|---|
GM018P09 (355093) |
[**] | [**] | [**] | |||
GM018P09 (355104) |
[**] | [**] | [**] | |||
GM018P09 |
[**] | [**] | [**] | |||
PT-C07082103-A08001-IND |
[**] | [**] | [**] | |||
PT-C07082103-AF08002-IND |
[**] | [**] | [**] |
NDP Bulk
(5 mg)
|
Lot # | DOM | Expiry (when pkgd) | Quantity (caps) | ||||
|---|---|---|---|---|---|---|---|---|
|
CT567262 | [**] | [**] | [**] | ||||
|
CT568785 | [**] | [**] | [**] | ||||
|
CT573009 | [**] | [**] | [**] |
Placebo
Batch#
|
DOM | Expiry | Quantity (caps) | |||
|---|---|---|---|---|---|---|
CT554194 |
[**] | [**] | [**] |
Ref Std
Batch#
|
Type | Expiry | Quantity (g) | |||
|---|---|---|---|---|---|---|
RS0554 |
Quantitative | [**] | [**] | |||
RS0615 |
For ID Only | [**] | [**] | |||
RS0715 |
Quantitative | [**] | [**] | |||
RS0722 |
Quantitative | [**] | [**] |
37
| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
Schedule 1.26
Lilly Know-How(*)
In addition to all files currently located in Lilly's dataroom:
38
| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
39
| | | | | |
| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. | ||||
| | | | | |
Schedule 1.27
Lilly Patent Rights
Lilly Reference |
Country | Application Number |
Application Date |
Patent Number |
Grant Date |
Status | Sub Status |
Publication Number |
Publication Date |
Expiration Date |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
X17934 |
Algeria | 100459 | 13-Jan-09 | 7295 | 15-Dec-11 | Granted | Granted | 13-Jan-29 | ||||||||||||
X17934 |
Argentina | P090100098 | 13-Jan-09 | Filed | Published | AR070158A 1 | 17-Mar-10 | |||||||||||||
X17934 |
Australia | 2009206653 | 13-Jan-09 | 2009206653 | 31-Oct-13 | Granted | Granted | 13-Jan-29 | ||||||||||||
X17934 |
Austria | 09703808.7 | 13-Jan-09 | E562999 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Belgium | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Brazil | PI0907382-5 | 13-Jan-09 | Filed | Filed | |||||||||||||||
X17934 |
Bulgaria | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Canada | 2713025 | 13-Jan-09 | 2713025 | 04-Dec-12 | Granted | Granted | 13-Jan-29 | ||||||||||||
X17934 |
Chile | 50-2009 | 13-Jan-09 | Filed | Filed | |||||||||||||||
X17934OP |
Chile | 50-2009 | 13-Jan-09 | Filed | Opposition | |||||||||||||||
X17934 |
China P.R. | 200980102650.4 | 13-Jan-09 | ZL200980102650.4 | 06-Feb-13 | Granted | Granted | 12-Jan-29 | ||||||||||||
X17934 |
Colombia | 10-099.271 | 13-Jan-09 | 2216 | 13-Dec-13 | Granted | Granted | 629 | 20-Jun-11 | 13-Jan-29 | ||||||||||
X17934 |
Costa Rica | 11559 | 13-Jan-09 | Filed | Published | 12-Oct-10 | ||||||||||||||
X17934 |
Croatia | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Cyprus | 09703808.7 | 13-Jan-09 | CY1113071 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Czech Republic | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Denmark | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Dominican Republic | P2010-0222 | 13-Jan-09 | Filed | Published | 31-Aug-10 | ||||||||||||||
X17934 |
Ecuador | SP-10-10365-PCT | 13-Jan-09 | Inactive | Abandoned | |||||||||||||||
X17934 |
Egypt | PCT 1072/2010 | 13-Jan-09 | Filed | Filed | |||||||||||||||
X17934 |
El Salvador | E-3632-2010 | 13-Jan-09 | Filed | Published | 388 | 20-Sep-10 | |||||||||||||
X17934 |
Estonia | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Eurasian Patent Convention | 201070877 | 13-Jan-09 | 017484 | 28-Dec-12 | Granted | Granted | 201070877 | 30-Dec-10 | 13-Jan-29 | ||||||||||
X17934 |
European Patent Convention | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Inactive | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Finland | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
France | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Germany | 09703808.7 | 13-Jan-09 | 602009007707.4 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 |
40
| | | | | |
| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. | ||||
| | | | | |
Lilly Reference |
Country | Application Number |
Application Date |
Patent Number |
Grant Date |
Status | Sub Status |
Publication Number |
Publication Date |
Expiration Date |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
X17934 |
Great Britain | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Greece | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 14-Jan-29 | ||||||||||
X17934 |
Guatemala | A2010.000212 | 13-Jan-09 | 5776 | 14-Jul-14 | Granted | Granted | 13-Jan-29 | ||||||||||||
X17934 |
Gulf Cooperation Council | GCC/P/2009/12657 | 13-Jan-09 | Filed | Filed | |||||||||||||||
X17934 |
Honduras | 2010-1319 | 13-Jan-09 | 5455 | 25-Oct-13 | Granted | Granted | 13-Jan-29 | ||||||||||||
X17934 |
Hong Kong | 11100691.9 | 24-Jan-11 | HK1146822 | 26-Oct-12 | Granted | Granted | 1146822A | 15-Jul-11 | 13-Jan-29 | ||||||||||
X17934 |
Hungary | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Iceland | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
India | 1222/MUMNP/2010 | 13-Jan-09 | Filed | Filed | |||||||||||||||
X17934 |
Indonesia | W-00 2010 02459 | 13-Jan-09 | Filed | Filed | |||||||||||||||
X17934 |
Ireland | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Israel | 206038 | 13-Jan-09 | 206038 | 01-Mar-14 | Granted | Granted | 11/2013 | 28-Nov-13 | 13-Jan-29 | ||||||||||
X17934 |
Italy | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Japan | 2010-543182 | 13-Jan-09 | 5345637 | 23-Aug-13 | Granted | Granted | 2011-524850 | 08-Sep-11 | 13-Jan-29 | ||||||||||
X17934 |
Jordan | 15/2009 | 13-Jan-09 | 2797 | 22-Jun-14 | Granted | Granted | 530 | 15-Mar-14 | 13-Jan-29 | ||||||||||
X17934 |
Korea South | 10-2010-7016401 | 13-Jan-09 | 10-1172170 | 01-Aug-12 | Granted | Granted | 13-Jan-29 | ||||||||||||
X17934 |
Latvia | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Lebanon | 8509 | 13-Jan-09 | 8509 | 15-Oct-10 | Granted | Granted | 13-Jan-29 | ||||||||||||
X17934 |
Liechtenstein | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Lithuania | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Luxembourg | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 14-Jan-29 | ||||||||||
X17934 |
Macao | J/001050 | 09-Apr-13 | J/001050 | 16-Jul-13 | Granted | Granted | 03-Jan-29 | ||||||||||||
X17934 |
Macedonia | MK/P2012/249 | 13-Jan-09 | 904423 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Malaysia | P12010003437 | 13-Jan-09 | Filed | Filed | |||||||||||||||
X17934 |
Malta | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Mexico | MX/a/20 10/007849 | 13-Jan-09 | 293961 | 16-Dec-11 | Granted | Granted | 13-Jan-29 | ||||||||||||
X17934 |
Monaco | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Morocco | PV/33041 | 13-Jan-09 | Filed | Filed | |||||||||||||||
X17934 |
Netherlands | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 |
41
| | | | | |
| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. | ||||
| | | | | |
Lilly Reference |
Country | Application Number |
Application Date |
Patent Number |
Grant Date |
Status | Sub Status |
Publication Number |
Publication Date |
Expiration Date |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
X17934 |
New Zealand | 586225 | 13-Jan-09 | 586225 | 03-Sep-12 | Granted | Granted | 1595 | 25-May-12 | 13-Jan-29 | ||||||||||
X17934 |
Nigeria | NG/C/2010/421 | 13-Jan-09 | NG/C/2010/421 | 07-Jun-11 | Granted | Granted | 13-Jan-29 | ||||||||||||
X17934 |
Norway | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Pakistan | 33/2009 | 13-Jan-09 | 140737 | 12-Sep-l1 | Granted | Granted | 22-Jan-28 | ||||||||||||
X17934 |
Patent Cooperation Treaty | PCT/US2009/030811 | 13-Jan-09 | Inactive | National | WO 2009/094260 | 2009/094260 | 30-Jul-09 | ||||||||||||
X17934 |
Peru | 36-2009 | 13-Jan-09 | 6814 | 30-Apr-13 | Granted | Granted | 13172009 | 03-Sep-09 | 13-Jan-29 | ||||||||||
X17934 |
Philippines | 1-2010-501647 | 13-Jan-09 | Filed | Filed | 30-Jul-09 | ||||||||||||||
X17934 |
Poland | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Portugal | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Romania | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Russian Federation | 201070877 | 13-Jan-09 | 017484 | 28-Dec-12 | Granted | Granted | 201070877 | 30-Dec-10 | 13-Jan-29 | ||||||||||
X17934 |
Singapore | 201005057-3 | 13-Jan-09 | 163142 | 31-Jan-13 | Granted | Granted | 13-Jan-29 | ||||||||||||
X17934 |
Slovak Republic | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Slovenia | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
South Africa | 2010/03908 | 13-Jan-09 | 2010/03908 | 30-Nov-11 | Granted | Granted | 30-Nov-11 | 13-Jan-29 | |||||||||||
X17934 |
Spain | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2388708 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Sweden | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Switzerland | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Taiwan | 09810183 | 13-Jan-09 | I422369 | 11-Jan-14 | Granted | Granted | I422369 | 11-Jan-14 | 12-Jan-29 | ||||||||||
X17934 |
Thailand | 0901000108 | 13-Jan-09 | Filed | Published | 104143 | 23-Sep-10 | |||||||||||||
X17934 |
Trinidad & Tobago | TT/A/2010/00153 | 13-Jan-09 | Filed | Filed | |||||||||||||||
X17934 |
Tunisia | TN2010/0306 | 13-Jan-09 | Filed | Filed | |||||||||||||||
X17934 |
Turkey | 09703808.7 | 13-Jan-09 | TR201208827T4 | 20-Jun-12 | Granted | Granted | 2252581 | 24-Nov-10 | 13-Jan-29 | ||||||||||
X17934 |
Ukraine | 2010 08931 | 13-Jan-09 | 100715 | 25-Jan-13 | Granted | Granted | 13-Jan-29 | ||||||||||||
X17934 |
United States | 12/352869 | 13-Jan-09 | 7709522 | 04-May-10 | Granted | Granted | 20090186873 | 23-Ju1-09 | 13-Jan-29 | ||||||||||
X17934A |
United States | 12/757451 | 09-Apr-10 | 8173695 | 08-May-12 | Granted | Granted | 20100197669 | 05-Aug-10 | 13-Jan-29 | ||||||||||
X17934 |
Uzbekistan | IAP 2010 0403 | 13-Jan-09 | IAP 04707 | 28-Jun-13 | Granted | Granted | 28-Jun-13 | 13-Jan-29 | |||||||||||
X17934 |
Venezuela | 2009-000054 | 13-Jan-09 | Filed | Published | 521 | 01-Aug-11 | |||||||||||||
X17934 |
Vietnam | 1-2010-01876 | 13-Jan-09 | 10913 | 11-Dec-12 | Granted | Granted | 13-Jan-29 |
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| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
Attachment 3.02(a)
Initial Development Plan
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| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
Technology Transfer
Clinical
CMC
Regulatory
Non-Clinical
Intellectual Property
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| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
Attachment 9.03
Initial Press Release
Cerecor Bolsters Clinical Pipeline with Acquisition of Phase 2-ready Kappa Opioid Receptor Antagonist from Eli Lilly and Company
BALTIMORE, February xx, 2015 — Cerecor Inc, a clinical-stage biopharmaceutical company developing treatments to make a difference in the lives of patients with neurological and psychiatric disorders, today announced that it has acquired exclusive, worldwide rights from Eli Lilly and Company ("Lilly") to develop and commercialize LY2456302 (which will be designated as CERC-501), a Phase 2-ready, potent and selective kappa opioid receptor (KOR) antagonist. KORs are believed to play a key role in modulating stress, mood and addictive disorders. Research also suggests that selective KOR antagonists can block both the physical and emotional symptoms of nicotine withdrawal.
CERC-501 was discovered and developed by Lilly for the treatment of co-occurring disorders, defined as a patient having one or more disorders relating to substance abuse combined with one or more mental health disorders. In Phase 1 clinical studies, CERC-501 was well tolerated, penetrated the blood-brain barrier and demonstrated target engagement, as shown through PET (positron emission tomography) imaging.
"Evidence of human kappa receptor binding coupled with unique competitive positioning and broad development potential make CERC-501 a key addition to Cerecor's pipeline, strengthening our position in the development of novel neuroscience compounds for underserved neurological and psychiatric disorders," said Dr. Blake Paterson, Cerecor's co-founder and CEO. "Clinicians, patients and families who struggle with mood and addictive disorders will recognize the need for more effective treatments, and we plan to initially develop CERC-501 to address nicotine dependence."
"CERC-501 is a potential first-in-class, best-in-class, oral medication to treat depression and co-occurring substance use disorders, such as alcohol, nicotine and/or illicit drug addiction," added Dr. Reza Mazhari, Cerecor's Vice President of Drug Discovery and Development. "A planned clinical trial in nicotine dependence will afford us the opportunity to rapidly evaluate the effect of CERC-50I on tobacco reinstatement, and assess subject's craving, mood and anxiety during abstinence periods. If successful, this initial study could open the doors to additional indications for CERC-501 going forward."
Under the terms of the agreement, Cerecor will immediately assume full development and commercialization responsibilities of CERC-501. License consideration includes undisclosed milestone payments and royalties. Cerecor anticipates completing the technology transfer activities by mid-2015 and initiating clinical trials in the second-half of the year.
About Cerecor
Cerecor Inc ("Cerecor") is a Baltimore-based biopharmaceutical company developing proprietary treatments to make a difference in the lives of patients with neurological and psychiatric diseases by addressing the unmet medical needs of underserved patient segments. We are committed to the development of drugs that improve lives by applying our extensive knowledge and experience in central nervous system disorders. www.cerecor.com
Media Contact: Michelle Avery, MacDougall Biomedical Communications, 781-235-3060
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| Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. |
Schedule 10.02(f)
Existing Agreements
Research Agreements:
EXIST Agreements:
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| This ‘S-1’ Filing | Date | Other Filings | ||
|---|---|---|---|---|
 | ||||
| Filed on: | 6/12/15 | None on these Dates | ||
| 9/25/14 | ||||
| List all Filings | ||||
As Of Filer Filing For·On·As Docs:Size Issuer Filing Agent 3/29/24 Avalo Therapeutics, Inc. 10-K 12/31/23 83:9.6M Workiva Inc Wde… FA01/FA 4/12/23 Avalo Therapeutics, Inc. S-3 5:752K Workiva Inc Wde… FA01/FA 3/29/23 Avalo Therapeutics, Inc. 10-K 12/31/22 82:10M Workiva Inc Wde… FA01/FA 3/02/22 Avalo Therapeutics, Inc. 10-K 12/31/21 91:11M Workiva Inc Wde… FA01/FA 3/08/21 Avalo Therapeutics, Inc. 10-K 12/31/20 82:11M Workiva Inc Wde… FA01/FA 10/09/15 SEC UPLOAD¶ 9/23/17 1:158K Avalo Therapeutics, Inc. 9/18/15 SEC UPLOAD¶ 9/23/17 1:148K Avalo Therapeutics, Inc. 6/22/15 SEC UPLOAD¶ 9/23/17 1:157K Avalo Therapeutics, Inc. |