EX-10.3 14 a2224996zex-10_3.htm EX-10.3 QuickLinks -- Click here to rapidly navigate through this document 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...
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
Xxx Xxxxx 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 Xxx 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, Licensee desires to develop and commercialize XX0000000; and
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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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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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:
- a)
- Trade, quantity and cash discounts allowed;
- b)
- Discounts, refunds, rebates, chargebacks, retroactive price adjustments, and any other allowances which effectively reduce the net selling price;
- c)
- Licensed Product returns, rejections, damaged goods and allowances; and
- d)
- Tariffs, duties, excise, sales, value-added and other similar taxes (other than taxes based on income), customs duties or other government charges, in each case imposed on the sale of Licensed product to the extent included in the price and separately itemized on the invoice, including VAT, but only to the extent that such VAT are not reimbursable or refundable.
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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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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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.
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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.
- (a)
- Licensee shall remain responsible for its sublicensees' performance under this Agreement.
- (b)
- Licensee shall provide, in the Development Report required pursuant to Section 3.03, a list of any sublicensees granted a sublicense during the preceding twelve (12) months. At Lilly's request, Licensee shall provide to Lilly a copy of any sublicense agreement.
- (c)
- Each and every sublicense granted by Licensee to a sublicensee must be in a written agreement, in English, executed by the sublicensee and giving its place of business. In addition, each and every such sublicense must be consistent with those terms of this Agreement which are applicable to that portion of the Field and/or Territory to which the sublicensee has been granted rights, including, without limitation, must require the sublicensee to abide by confidentiality and non-use obligations at least as stringent as those contained in Article IX of this Agreement.
- (d)
- In the event that that this Agreement is terminated in its entirety by Licensee pursuant to Section 12.02 or Lilly for any reason as permitted under the Agreement, each sublicense granted by Licensee will survive such termination (as a direct license from Lilly), subject to Section 12.06, provided that Lilly has agreed following such termination and/or in connection therewith that the sublicensee is acceptable to Lilly.
- **
- CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
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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.
ARTICLE III — DEVELOPMENT AND COMMERCIALIZATION
3.02 Development and Commercialization Plans.
- (a)
- Initial Development Plan. An initial Development plan for the Licensed Product in the Field in the Territory is attached hereto as Attachment 3.02(a) (as may be amended in accordance with this Agreement, the "Development Plan").
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- (b)
- Annual Development Plan. Not later than sixty (60) days after December 31 of each Calendar Year, Licensee shall submit to Lilly an updated Development Plan for the pending Calendar Year. Such update shall take into account the anticipated Development activities, for the applicable development period, of Licensee or a Related Party for the Development of Licensed Product in the Field. Lilly shall have the right to comment on such annual plan, provided, however, that Licensee shall not be obligated to incorporate such Lilly comments and Licensee retains final decision making authority with respect to all such plans.
- (c)
- Performance. Licensee shall perform, and shall ensure that its Affiliates, sublicensees, and Third Party contractors perform, the activities described in the Development Plan in a professional manner and in compliance with, to the extent applicable, Good Laboratory Practices, Good Clinical Practices and/or Good Manufacturing Practices and in compliance with all other applicable laws, rules, and regulations.
3.06 [**]
ARTICLE IV — TRANSFER OF LILLY KNOW-HOW & EXISTING STUDIES
4.01 Materials and Regulatory Filings Transfer.
- (a)
- Promptly following the Effective Date, but in any event, within [**] days thereof: (i) Lilly will provide Licensee with the Licensed Compounds listed in Schedule 1.23 and Lilly Know-How listed in Schedule 1.26; and (ii) Lilly shall transfer to Licensee, in a mutually agreed manner,
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- CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
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- the quantities of available physical inventory of Licensed Compounds solely as listed in Schedule 1.23 and shall inform Licensee in writing as to the quantities of such physical inventory that are in compliance with Good Manufacturing Practices; provided that the quantities listed are general guidance estimates only of the amounts currently anticipated to be available for shipping from Lilly. Such inventory shall only be used in preclinical work in accordance with the license grant in Section 2.01 herein and to the extent that such inventory was not recertified by Lilly as compliant with Good Manufacturing Practices, shall not be used for clinical or commercial purposes. Lilly shall have no responsibility to recertify or re-test any physical inventory to be provided under the Agreement, including if it is beyond its dating period (i.e., the material may require additional stability data and/or analytical testing prior to use, given its age). Lilly shall provide the reports and data as described in Schedule 1.26 in a single copy in electronic format if available otherwise in paper. Lilly shall be responsible for all costs associated with transfer of Lilly Know-How.
- (b)
- Promptly following the Effective Date, but in any event, within [**] days thereof, Lilly shall transfer to Licensee the existing INDs and other drug approval applications covering the Licensed Product in electronic format if available, otherwise in paper. Lilly hereby assigns all right, title and interest in any to the foregoing INDs and drug approval applications to Licensee. All further submissions to any Regulatory Authorities relating to such drug approval applications and/or INDs shall be filed in the name of and owned by Licensee or its Affiliates. Licensee or its Affiliates shall own and/or hold all Marketing Authorizations for Licensed Product throughout the Territory. Licensee shall be responsible for ensuring the IND transfer is done properly.
- (c)
- Promptly following the Effective Date, but in any event, within [**] days thereof, Lilly shall transfer to Licensee one (1) copy of the material documents and records that have been generated by or on behalf of Lilly with respect to any existing INDs and other drug approval applications covering the Licensed Product in the Territory, as well as any material correspondence between Lilly and Regulatory Authorities related to Licensed Product in electronic format if available.
- (d)
- Licensee shall be responsible for overseeing, monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, the FDA and other Regulatory Authorities in the Territory with respect to Licensed Product.
- (e)
- Licensee shall be solely responsible for interfacing, corresponding and meeting with the FDA and other regulatory authorities throughout the Territory with respect to Licensed Product.
- (f)
- Licensee shall provide to Lilly a table report on an annual basis that contains the status of Marketing Authorizations for the Licensed Product in the Territory.
- **
- CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PUR- SUANT TO A CONFIDENTIAL TREATMENT REQUEST.
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- (g)
- In the event that any Regulatory Authority (a) threatens or initiates any action to remove a Licensed Product from the market in any country in the Field in the Territory or (b) requires Licensee, its Affiliates, or its sublicensees to distribute a "Dear Doctor" letter or its equivalent regarding use of Licensed Product in the Field, Licensee shall notify Lilly of such event within three (3) business day after Licensee becomes aware of the action, threat, or requirement (as applicable). Licensee shall keep Lilly reasonably informed with respect to any recall or withdrawal of Licensed Product in the U.S., Japan, or a Major European Country; provided, however, that the final decision as to whether to recall or withdraw a Licensed Product in the Territory shall be made by Licensee in its sole discretion. Licensee shall be responsible, at its sole expense, for conducting any recalls or taking such other necessary remedial action. Lilly shall, at the request and reasonable expense of Licensee, cooperate with Licensee (including providing assistance and support) on any recall or withdrawal of Licensed Product to the extent necessary to comply with applicable laws, rules and regulations or any requirements by the Regulatory Authority.
4.02 Pharmacovigilance and Product Complaints.
- (a)
- Following the transfer of any INDs related to Licensed Product from Lilly to Licensee, Licensee shall be solely responsible for the collection, review, assessment, tracking and filing of information related to adverse events ("AEs") associated with Licensed Product, in accordance with 21 CFR 312.32, 314.80 and comparable regulations, guidance, directives and the like governing AEs associated with Licensed Product that are applicable outside of the United States.
- (b)
- Within [**] days of the Effective Date, Lilly will provide Licensee with all AEs reports, copies of all study reports of completed studies (including copies of the protocols), and copies of all available interim study analyses, as they may already exist, of all ongoing studies for Licensed Product (including copies of protocols) to the extent not previously provided to Licensee. In furtherance of the foregoing, Lilly shall transfer to Licensee any available relevant information, in a format mutually agreed by the Parties, regarding adverse events that have been observed during any clinical trials conducted with respect to Licensed Product prior to the Effective Date.
- (c)
- Within a reasonable period of time following receipt of all such information described in this Section 4.02, and in no event later than forty-five (45) days after the receipt of such information, Licensee shall assume responsibility for maintaining a global safety database for Licensed Product consistent with industry practices.
- (d)
- Licensee will be responsible to notify Lilly of any product complaints (non-AEs) associated with material supplied by Lilly. Lilly will be responsible to support the investigation of the product complaints as it relates to the activities conducted by Lilly and share the results of the investigation with Licensee.
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
- **
- CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
13
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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.
14
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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
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 | $[**] |
- (b)
- Aggregate Net Sales Milestone Payments. Subject to the terms and conditions of this Agreement and in further consideration for the license granted herein, Licensee shall make each of the following one-time, non-refundable, non-creditable milestone payments to Lilly the first time the aggregate Net Sales of all Licensed Products meets or exceeds the following thresholds:
- •
- [**] U.S. dollars ($[**]) at the end of the first calendar year in which aggregate Net Sales for Licensed Products in such calendar year exceeds $[**] million; and
- **
- CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
15
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- •
- [**] U.S. dollars ($[**]) at the end of the first calendar year in which aggregate Net Sales for Licensed Products in such calendar year exceeds $[**] billion.
- (c)
- Notice and Payment. Licensee shall notify Lilly in writing within ten (10) business days after the achievement of each such milestone event by Licensee, its Affiliates or a sublicensee giving rise to a payment obligation under this Section 7.02 and Licensee shall pay Lilly the indicated amount no later than forty-five (45) days after such notification to Lilly.
- (a)
- Royalty Rates. Subject to the terms and conditions of this Agreement, Licensee shall pay to Lilly royalties on Net Sales made by Licensee, its Affiliates or sublicensees of any Licensed Product commencing upon the First Commercial Sale of a Licensed Product in a particular country in the Territory and will continue on a Licensed Product-by-Licensed Product and coun- try-by-country basis until the later of (i) the expiration of the last to expire Valid Patent Claim covering a Licensed Product in such country, or (ii) 11 (eleven) years from First Commercial Sale of the Licensed Product in such country, at tiered rates set forth for the U.S. and tiered rates set forth for the portion of ex- U.S. Net Sales as follows:
- •
- For the first $[**] U.S. dollars of annual U.S. Net Sales for such Licensed Product: [**]; and
- •
- For the portion of U.S. dollars of annual U.S. Net Sales for such Licensed Products greater than $[**] but less than or equal to $[**], [**]; and
- •
- For the portion of U.S. dollars of annual U.S. Net Sales for such Licensed Products greater than $[**], [**]; and
- •
- For the first $[**] U.S. dollars of annual total ex-U.S. Net Sales for such Licensed Product: [**]., and
- •
- For the portion of U.S. dollars of annual total ex-U.S. Net Sales greater than $[**] U.S. dollars but less than or equal to $[**]: [**]., and
- •
- For the portion of U.S. dollars of annual total ex-U.S. Net Sales greater than $[**] U.S. dollars: [**].
- (b)
- Third Party Licenses — Royalty Offset. Should Licensee be required to enter into a third party license agreement for a patent that is necessary to Develop, manufacture and/or Commercialize Licensed Compounds and/or Licensed Products contemplated by this Agreement, Licensee may offset royalty payments due hereunder by fifty (50) percent of the amounts due under such third party license agreement, provided, that under no circumstance will the royalties due to Lilly be offset by more than fifty (50) percent of the royalties owed to Lilly.
- (c)
- Early Generic Product Entry. For a given Licensed Product, if in a given country within the Territory entry of a Generic Product has occurred and subsequently the sales of the Licensed Product have declined by (i) twenty-five percent (25%) or more as compared to the two consecutive Calendar Quarters immediately prior to such Generic Product entry, then the royalty payments due to Lilly for such Licensed Product in such country shall be reduced by
- **
- CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
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- fifty percent (50%) and/or (ii) seventy-five percent (75%) or more compared to the two consecutive Calendar Quarters immediately prior to such Generic Product entry, then no further royalty payments shall be due to Lilly for such Licensed Product in such country. Such reduction shall be first applied with respect to such country starting with sales in the Calendar Quarter following the entry of such Generic Product.
7.04 Reports; Payment of Royalty; Payment Exchange Rate and Currency Conversions.
- (a)
- Royalties Paid Quarterly. Licensee shall keep (and shall cause its affiliates and requires its sublicensees to keep) complete and accurate books and records that are necessary to ascertain and verify the payments owed hereunder. Within forty-five (45) calendar days following the end of each Calendar Quarter, following the First Commercial Sale of a Licensed Product, Licensee shall furnish to Lilly a written report for the Calendar Quarter showing the Net Sales by country of Licensed Product sold by Licensee and its Related Parties in the Territory during such Calendar Quarter and the royalties payable by country due on such Net Sales under this Agreement for such Calendar Quarter. Licensee shall provide Lilly with a sales forecast for the subsequent 8 quarters. Licensee will mail such reports to the attention of: Xxx Xxxxx and Company, Lilly Royalty Administration in Finance, Drop Code 0000, Xxxxx Xxxxxxxxx Xxxxxx, Xxxxxxxxxxxx, Xxxxxxx, 00000. Simultaneously with the submission of the written report, Licensee shall pay to Lilly the royalty due for such Calendar Quarter calculated in accordance with this Agreement.
- (b)
- Method of Payment. All payments to be made by Licensee to Lilly under this Agreement shall be paid by bank wire transfer in immediately available funds to such bank account as is designated in writing by Lilly from time to time. Royalty payments shall be made in United States dollars using the rate of exchange as defined in 1.31 Net Sales.
7.05 Maintenance of Records; Audits.
17
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- (b)
- Underpayments/Overpayments. If such accounting firm correctly concludes that additional royalties were owed during such period, Licensee shall pay such additional royalties within thirty (30) days of the date Lilly delivers to Licensee such accounting firm's written report so correctly concluding. If such underpayment exceeds [**] percent ([**]%) of the sums correctly due Lilly then the reasonable fees charged by such accounting firm for the work associated with the underpayment audit shall be paid by Licensee. For clarity, in all other circumstances the fees charged by such accounting firm for the work associated with the underpayment audit shall be paid by Lilly. Any overpayments by Licensee will be credited against future royalty obligations or at Licensee's request, promptly refunded to Licensee.
- (c)
- Confidentiality. Lilly shall treat all financial information subject to review under this Section 7.05, in accordance with the confidentiality provisions of Article IX of this Agreement.
- (d)
- Late Payments. Any amount owed by Licensee to Lilly under this Agreement that is not paid within the applicable time period set forth herein shall accrue interest at the rate of the one (1) month London Inter-Bank Offering Rate ("LIBOR") plus [**] percent ([**]%) as set by the British Bankers Association as of the due date, or whatever is the legal limit if lower.
- **
- CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
18
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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.
8.04 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.
19
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- infringement in some context other than a Paragraph IV certification, following receipt of notice of the alleged infringement, Lilly shall have the right to bring suit or otherwise take action with respect to such infringement at its own expense and by counsel of its own choice, and Licensee shall have the right, at its own expense, to be represented in any such suit by counsel of its own choice.
- (b)
- Expenses and Cooperation. Each Party shall cooperate with and provide to the Party enforcing any such rights under this Section 8.05 reasonable assistance in such enforcement, at such enforcing Party's request and expense. Lilly further agrees to join, at Licensee's expense, any such action brought by Licensee under this Section 8.05 as a party plaintiff if required by applicable law to pursue such action. The enforcing Party under this Section 8.05 shall keep the other Party regularly informed of the status and progress of such enforcement efforts, and shall reasonably consider the other Party's comments on any such efforts. In the event that Lilly is a party to such a legal action, no settlement, consent judgment or other voluntary final disposition of the suit may be entered into without the mutual consent of Licensee and Lilly, and such consent shall not be unreasonably withheld. In no event shall Licensee or Xxxxx xxxxxx any such action or proceeding in a manner which restricts the scope, or adversely affects the enforceability, of Lilly
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.
20
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ARTICLE IX — CONFIDENTIALITY AND PUBLICATION
- (a)
- Nondisclosure Obligation. Each of Lilly and Licensee shall use any Proprietary Information
received by it from the other Party only in accordance with this Agreement and shall not disclose to any Third Party any such Proprietary Information without the prior written consent of the other
Party. The foregoing obligations shall survive the expiration or termination of this Agreement for a period of [**]
([**]) years. These obligations shall not apply to Proprietary Information that:
- (i)
- is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by the receiving Party's written records;
- (ii)
- is at the time of disclosure, or thereafter becomes, published or otherwise part of the public domain without breach of the obligations of confidentiality under this Agreement by the receiving Party;
- (iii)
- is subsequently disclosed to the receiving Party by a Third Party who has the right to make such disclosure, as documented by the receiving Party's written records; or
- (iv)
- is independently developed by the receiving Party or its Affiliates and without the aid, use or application of any of the disclosing Party's Proprietary Information, and such independent development can be documented by the receiving Party's written records.
- (b)
- Authorized Disclosure. Each Party shall have the right to disclose Proprietary Information received by it from the other Party to the extent required to be disclosed by law, regulation, rule, act or order of any governmental authority or agency to be disclosed, provided that notice is promptly delivered to the other Party (to the extent permitted) in order to provide an opportunity to seek a protective order or other similar order with respect to such Proprietary Information and thereafter the receiving Party discloses to the requesting entity only the minimum information required to be disclosed in order to comply with the request, whether or not a protective order or other similar order is obtained by the other Party.
- (c)
- Permitted Disclosures. Notwithstanding provisions of Section 9.01(a),
Licensee, its Affiliates or sublicensees shall have the right to disclose Proprietary Information received by it from
Lilly:
- (i)
- to any institutional review board of any entity conducting Clinical Trials with Licensed Product or to any governmental or other regulatory agencies in order to obtain patents or to gain approval to conduct Clinical Trials or to market Licensed Product, provided that such disclosure may be made only to the extent reasonably necessary to obtain such patents or authorizations; or
- (ii)
- to any bonafide potential or actual investor, investment banker, acquirer, merger partner, or other potential or actual financial partner; provided that in connection with such
- **
- CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
21
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- disclosure, Licensee shall require each disclosee to enter into a confidentiality agreement with respect to such Proprietary Information.
- (d)
- Disclosure to Agents. Notwithstanding the provisions of Section 9.01(a) and subject to the other terms of this Agreement, each of Licensee and Lilly shall have the right to disclose Proprietary Information to their respective sublicensees, agents, consultants, Affiliates or other Third Parties (collectively "Agents") in accordance with this Section 9.01(d) . Such disclosure shall be limited only to those Agents directly involved in the development, manufacturing, marketing or promotion of Licensed Compound or Licensed Product (or for such Agents to determine their interest in performing such activities) in accordance with this Agreement. Any such Agents must agree in writing to be bound by confidentiality and non-use obligations no less restrictive than those contained in this Agreement.
- (e)
- Disclosure to Taxing Authorities. Notwithstanding the provisions of Section 9.01(a), either Party shall be permitted and allowed to provide a copy of this Agreement to the United States Internal Revenue Service or other tax authorities, if requested, without advanced written notice or approval of the other Party.
22
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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.
ARTICLE X — REPRESENTATIONS AND WARRANTIES
- (a)
- it is a corporation duly organized and validly existing under the laws of the state or other jurisdiction of its incorporation;
- (b)
- the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action;
- (c)
- it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder;
- (d)
- the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions herein does not and will not conflict with or result in a breach of any of the terms and provisions of or constitute a default under (i) a loan agreement,
23
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- guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its corporate charter or other operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound;
- (e)
- except for the governmental and Marketing Authorizations required to market the Licensed Product in the Territory, the execution, delivery and performance of this Agreement by such Party does not require the consent, approval or authorization of, or notice, declaration, filing or registration with, any governmental or Regulatory Authority and the execution, delivery or performance of this Agreement will not violate any law, rule or regulation applicable to such Party;
- (f)
- this Agreement has been duly authorized, executed and delivered and constitutes such Party's legal, valid and binding obligation enforceable against it in accordance with its terms subject, as to enforcement, to bankruptcy, insolvency, reorganization and other laws of general applicability relating to or affecting creditors' rights and to the availability of particular remedies under general equity principles; and
- (g)
- it shall comply with all applicable laws and regulations relating to its activities under this Agreement.
- (a)
- Schedule 1.27 accurately identifies all patents and patent applications owned or controlled by Lilly as of the Effective Date that are necessary or useful for the, and/or in absence of a license, would prevent Licensee to, research, Develop, Manufacture, use and/or Commercialize Licensed Compounds and Licensed Products as contemplated by this Agreement;
- (b)
- Lilly is the sole owner of the entire right, title and interest in and to all patents, patent applications and other intellectual property rights within the Lilly Patent Rights and Lilly Know-How. Lilly has the full and legal rights and authority to license to Licensee the Lilly Patent Rights and Lilly Know-How, and (i) it has not previously transferred, assigned, conveyed or otherwise encumbered its right, title and interest in and to the Licensed Compound or Licensed Product to any Third Party, and (ii) no Third Party has any license, option or other rights or interest in or to the Lilly Patent Rights and Lilly Know-How or any part thereof, in each case with respect to any Licensed Compound or Licensed Product. Lilly has not received, nor is it aware of, any claims or allegations that a Third Party has any right or interest in or to any patent or patent application in the Lilly Patent Rights or in or to the Lilly Know-How with respect to any Licensed Compound or Licensed Product, or any claims or allegations by a Third Party that any patents or patent applications within the Lilly Patent Rights are invalid or unenforceable, except for the EPO Opposition;
- (c)
- To the best of its knowledge, no intellectual property rights of any Third Party were infringed or misappropriated during the creation of the Lilly Patent Rights or Lilly Know-How;
- (d)
- All issued patents within the Lilly Patent Rights are in good standing with the applicable patent office and all maintenance fees have been timely paid;
24
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- (e)
- To the best of its knowledge and belief, Lilly has provided Licensee with all relevant information reasonably required for Licensee to properly evaluate and conduct due diligence on the Lilly Patent Rights, including all information relating to the EPO Opposition and complete copies of all Existing Agreements, and all such information are true and accurate.
- (f)
- Schedule 10.02(f) sets forth the true and complete list of all material transfer agreements [and clinical study agreements][NTD: TBD.] relating to the Licensed Compound and/or Licensed Product, which agreements were entered into by Lilly and any Third Party prior to the Effective Date (collectively, "Existing Agreements"); and
- (g)
- All physical inventory of the Licensed Compound designated XX0000000 that is transferred to Licensee pursuant to Section 4.01(a) and that has been recertified prior to the Effective Date by Lilly as in compliance with Good Manufacturing Practices (i) were manufactured, stored and transported in accordance with Good Manufacturing Practices and any applicable federal, state and local laws, rules and regulations and (ii) complies at the time of delivery with the specifications established by Lilly for administration to humans.
25
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ARTICLE XI — INDEMNIFICATION AND LIMITATION ON LIABILITY
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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.
ARTICLE XII — TERM AND TERMINATION
27
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28
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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.
- (a)
- Subject to Section 12.06(b), Licensee shall, at its sole expense, transfer to Lilly (or its nominee) all physical inventories of Licensed Compound and Licensed Product, and all INDs, Marketing Authorizations, drug approval applications for Marketing Authorizations, and all supporting documentation for such filings and applications (to the extent assignable and not cancelled) assigned to Licensee by Lilly hereunder to the extent relating to Licensed Product then being Commercialized or in Development.
- (b)
- For a period of sixty (60) days after the effective date of termination, the Parties shall negotiate in good faith the financial terms (including, without limitation, royalties, mile- stones and upfronts) and conditions for (i) the transfer of all regulatory filings and documentation, and all physical inventories of Licensed Compound and Licensed Product pursuant to Section 12.06(a) and any other transition assistance required, (ii) the grant of a royalty-bearing license to Lilly under Licensee Know-How and/or Licensee Patent Rights existing as of such effective date of termination with respect to the Licensed Product then being developed as of the date of such termination, and (iii) the transition to Lilly of all clinical trials conducted by Licensee under Licensee's IND for Licensed Product that are ongoing as of the date of termination. Such sixty (60) day period may be extended by mutual written agreement of the Parties for an additional thirty (30) days. In the event that the Parties are unable to mutually agree upon the commercially reasonable compensation and terms with respect to the foregoing within such period, the matter shall be referred to a mutually agreed upon third party expert in the valuation of life sciences assets, each Party shall provide to such third party all information in its control necessary for such third party to resolve such matter, and the costs for such expert shall be borne equally by the Parties.
- (c)
- Upon the request of Lilly, Licensee shall use reasonable efforts to assign to Lilly any sublicenses previously granted by Licensee related to Licensed Product.
29
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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
- (a)
- The arbitration proceeding shall be conducted under the Commercial Arbitration Rules of the American Arbitration Association ("AAA") with such proceedings to be held in Newark, New Jersey, United States. In all cases, the arbitration proceedings shall be conducted in the English language, and all documents that are submitted in the proceeding shall be in the English language. Judgment upon the award rendered by arbitration may be issued and enforced by any court having competent jurisdiction.
- (b)
- If a Party intends to begin an arbitration to resolve a dispute, such Party shall provide written notice to the other Party, informing the other Party of such intention and any statement of claim required under the applicable arbitration rules (as determined in accordance with Section 13.02(a)). Within twenty (20) business days after its receipt of such notice, the other Party shall, by written notice to the Party initiating arbitration, add any additional issues to be resolved that would be considered mandatory counterclaims under Delaware law. For clarity, the resolution of any disputes regarding such counterclaims shall be conducted in the same proceedings as the initial claims.
- **
- CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
30
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- (c)
- Within forty-five (45) days following the receipt of the notice of arbitration, the Party referring
the matter to arbitration shall appoint an arbitrator and promptly notify the other Party of such appointment. The other Party shall, upon receiving such notice, appoint a second arbitrator within
twenty one (21) days, and the two (2) arbitrators shall, within fifteen (15) days of the appointment of the second arbitrator, agree on the appointment of a third arbitrator who
will act with them and be the chairperson of the arbitration panel. In the event that either Party shall fail to appoint an arbitrator within thirty (30) days after the commencement of the
arbitration proceeding, the arbitrator shall be appointed by the AAA. In the event of the failure of the two (2) arbitrators to agree within sixty (60) days after the commencement of the
arbitration proceeding to appoint the chairperson, the chairperson shall also be appointed by the AAA.
- (i)
- All of the arbitrators shall have significant legal or business experience in pharmaceutical licensing matters. The arbitrators shall not be employees, directors or shareholders of either Party or any of their Affiliates.
- (ii)
- Each Party shall have the right to be represented by counsel throughout the arbitration proceedings.
- (iii)
- To the extent possible, the arbitration hearings and award will be maintained in confidence.
- (iv)
- In any arbitration pursuant to this Agreement, the award or decision shall be rendered by a majority of the members of the panel provided for herein, with each member having one (1) vote. The arbitrators shall render a written decision with their resolution of the dispute that shall set forth in reasonable detail the facts of the dispute and the reasons for their decision. The decision of the arbitrators shall be final and non-appealable and binding on the Parties.
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.
- (a)
- Except as provided in this Section 14.01, this Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the consent of the other Party; provided, however, that Lilly may, without such consent, assign the Agreement and its rights and obligations hereunder to an Affiliate or in connection with a Change of Control. Licensee may, without Lilly's consent, assign this Agreement and its rights and obligations hereunder to an Affiliate or in connection with a Licensee Change of Control.
- (b)
- Any permitted assignee shall assume all assigned obligations of its assignor under the Agreement. The terms and conditions of this Agreement shall be binding upon and shall inure to the benefit of the Parties and their respective successors and permitted assigns. This Agreement shall be binding upon, and inure to the benefit of, each Party, its Affiliates, and its permitted successors and assigns. Each Party shall be responsible for the compliance by its Affiliates with the terms and conditions of this Agreement.
- (c)
- The Licensed Patent Rights and Know-How, in the case of Lilly as assignor or transferor, or the Licensee Patent Rights and Licensee Know-How, in the case of Licensee as assignor or transferor, shall exclude any Patent Rights and Know-How controlled by any acquirer (or any Affiliate thereof, excluding the Party hereto that becomes an Affiliate of the acquirer as a result of such transaction) either (i) prior to the Change of Control or (ii) developed outside of any activities under this Agreement.
- (d)
- Any attempted assignment not in accordance with Section 14.01 shall be null and void.
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.
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. |
if to Licensee, to: | Cerecor Inc. 000 Xxxx Xxxxx Xxxxxx Xxxxxxxxx, XX 00000 Attn : [**] [**] | |
With copy to (which copy shall not constitute notice): | [**], Esq. Xxxxxx LLP One Freedom Square Reston Town Center 00000 Xxxxxxx Xxxxx Xxxxxx, XX 00000-0000 Ph. [**] [**] | |
if to Lilly, to: | Xxx Xxxxx and Company Lilly Xxxxxxxxx Xxxxxx Xxxxxxxxxxxx, Xxxxxxx 00000 Attention: [**] Fax: [**] |
- **
- CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
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.
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. |
[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. |
XXX XXXXX AND COMPANY | CERECOR INC. | |||||
By: | /s/ XXX X. XXXXXXXX | By: | /s/ XXXXX XXXXXXXX | |||
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 (XX0000000) 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 | [**] | [**] |
- **
- CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
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:
- •
- Table of content of all documents included in the Product Data Package
- •
- Preclinical reports (ADME/PK, Pharmacology)
- •
- [**]
- •
- [**]
- •
- [**]
- •
- Toxicology reports
- •
- Global regulatory documents (some may be in paper), e.g.,
- •
- [**]
- •
- [**]
- •
- [**]
- •
- Clinical
- •
- [**]
- •
- [**]
- •
- [**]
- •
- [**]
- •
- [**]
- •
- [**]
- •
- CMC
- •
- [**]
- •
- [**]
- •
- [**]
- •
- [**]
- •
- [**]
- •
- [**]
- •
- [**]
- **
- CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
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. |
- •
- [**]
- •
- [**]
- •
- [**]
- •
- [**]
- •
- List of Publications
- •
- [**]
- •
- [**]
- •
- Presentations and associated files in powerpoint
- •
- [**]
- •
- [**]
- •
- Intellectual Property Materials
- •
- [**]
- •
- [**]
- •
- Marketing
- •
- [**]
- (*)
- Note: Lilly has not confirmed that all items listed in this Schedule 1.26 exist as of the Effective Date. Upon request by Cerecor, Lilly will make a reasonable search for any additional items listed above and not previously provided to Cerecor.
- **
- CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND 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 | Xxxxxxx | 000000 | 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 | 00-Xxx-00 | Xxxxxxx | Xxxxxxx | 00-Xxx-00 | ||||||||||||
X00000 | Xxxxxxxx | 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 | 00-Xxx-00 | 00-Xxx-00 | ||||||||||
X00000 | Xxxxxx | 09703808.7 | 13-Jan-09 | CY1113071 | 20-Jun-12 | Granted | Granted | 2252581 | 00-Xxx-00 | 00-Xxx-00 | ||||||||||
X00000 | Xxxxx Xxxxxxxx | 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 | 00-Xxx-00 | 00-Xxx-00 | ||||||||||
X00000 | Xxxxxxxxx Xxxxxxxx | 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 | 00-Xxx-00 | 00-Xxx-00 | ||||||||||
X00000 | Xxxxxx | 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 | 00-Xxx-00 | 00-Xxx-00 | ||||||||||
X00000 | Xxxxx | 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 | 00-0000-0000000 | 13-Jan-09 | 00-0000000 | 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 | 0-0000-000000 | 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 | 00-Xxx-00 | 00-Xxx-00 | ||||||||||
X00000 | Xxxxxxxx | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 00-Xxx-00 | 00-Xxx-00 | ||||||||||
X00000 | Xxxxx Xxxxxx | 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 | 00-Xxx-00 | 00-Xxx-00 | ||||||||||
X00000 | Xxxxxx | 09703808.7 | 13-Jan-09 | 2252581 | 20-Jun-12 | Granted | Granted | 2252581 | 00-Xxx-00 | 00-Xxx-00 | ||||||||||
X00000 | Xxxxxxxxxxx | 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 | Xxxxxxx | 00-Xxx-00 | ||||||||||||
X00000 | Xxxxxx Xxxxxx | 12/352869 | 13-Jan-09 | 7709522 | 04-May-10 | Granted | Granted | 20090186873 | 00-Xx0-00 | 00-Xxx-00 | ||||||||||
X00000X | Xxxxxx Xxxxxx | 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 | 0-0000-00000 | 13-Jan-09 | 10913 | 11-Dec-12 | Granted | Granted | 13-Jan-29 |
42
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
43
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
- •
- Finalize Clin501-201 Clinical Study Protocol for Nicotine Human Lab Study by 3Q2015
- •
- Title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of XX0000000 on Craving for Tobacco in Cigarette Smokers Seeking Treatment
- •
- Primary endpoint: To evaluate the effect of two dose levels of CERC-501 on tobacco reinstatement in subjects who have previously failed abstinence and experienced dysphoria and / or anxiety during quitting attempts
- •
- Anticipated study start-up and first subject randomized by 4Q2015
CMC
- •
- [**]
- •
- [**]
- •
- [**]
- •
- [**]
- •
- [**]
Regulatory
- •
- Meeting/communication with FDA regarding planned study by 3Q2015
Non-Clinical
- •
- [**]
Intellectual Property
- •
- [**]
- **
- CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
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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 Xxx Xxxxx 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 Xxx Lilly and Company ("Lilly") to develop and commercialize XX0000000 (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 Xx. Xxxxx Xxxxxxxx, 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 Xx. Xxxx Xxxxxxx, 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. xxx.xxxxxxx.xxx
Media Contact: Xxxxxxxx Xxxxx, XxxXxxxxxx Biomedical Communications, 000-000-0000
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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:
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EXIST Agreements:
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- CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
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