Exhibit 10.1
CONFIDENTIAL TREATMENT REQUESTED
LICENSE AGREEMENT
Effective Date of September 08, 2016
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LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this “Agreement”), effective as of this 8th day of September, 2016 (the “Effective Date”), is by and between Eli Lilly and Company (“Lilly”), and Cerecor Inc. (“Cerecor”), a corporation organized and existing under the laws of Delaware (hereinafter referred to as “Licensee”). Lilly and Licensee are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.
WHEREAS, Lilly and its Affiliates have discovered and developed the Transmembrane AMPA Receptor Regulatory Protein (TARP) gamma-8-dependent AMPA receptor antagonist designated as LY3130481;
WHEREAS, Licensee desires to develop and commercialize LY3130481; and
WHEREAS, Licensee and Lilly desire to enter into a license arrangement whereby Licensee will develop and commercialize LY3130481.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, Licensee and Lilly hereby agree as follows:
As used in this Agreement, the following capitalized terms, whether used in the singular or plural, shall have the respective meanings set forth below:
1.03 “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. |
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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. |
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. |
1.10 “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. |
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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 505(j) of the U.S. Federal Food, Drug, and Cosmetic Act or an equivalent outside the United States. |
1.18 “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. |
1.20 “Transmembrane AMPA Receptor Regulatory Protein (TARP) gamma-8-dependent AMPA Receptor Antagonist” shall mean an AMPA (α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor antagonist or inverse agonist which selectively targets transmembrane AMPA receptor regulatory protein (TARP) gamma-8-dependent AMPA . |
1.21 “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 |
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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. |
(a) |
any product containing a Licensed Compound which is covered in whole or in part by any Valid Patent Claim of the Lilly Patent Rights; |
(b) |
any product containing a Licensed Compound, the manufacture or use of which is covered in whole or in part by any Valid Patent Claim of the Lilly Patent Rights; and |
(c) |
any pharmaceutical product containing a Licensed Compound, including all dosage forms, formulations and line extensions thereof, including, without limitation, a Combination Product, except in the context of the calculation of Net Sales which is specifically addressed in Section 1.32. For avoidance of any doubt and notwithstanding anything to the contrary in this Agreement, the license granted under Section 2.01 of this Agreement with respect to Combination Product is limited to only the License Compound contained in such Combination Product and does not grant or convey any rights with respect to any other compound or ingredient that may be included in such Combination Product. |
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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 reasonably necessary 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 1.28 or is otherwise provided to Licensee by Lilly under this Agreement. |
1.30 “Major European Country” shall mean each of France, Germany, Italy, Spain or the United Kingdom. |
1.33 “Multiple Ascending Dose (MAD) Study” shall mean a study to investigate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple doses of Licensed Product |
1.35 “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: |
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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;
d) Allowance for distribution expenses * * * *;
e) The annual fee imposed on the pharmaceutical manufacturers by the U.S. government;
f) A reasonable allowance for uncollectible or bad debts; and
g) 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.
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
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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.
1.36 “Party” or “Parties” shall have the meaning given to such term in the preamble to this Agreement. |
1.38 “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. |
1.42 “Price Approval” shall mean the approval or determination by a Regulatory Authority for the pricing or pricing reimbursement for a pharmaceutical product. |
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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. |
1.45 “Related Party” shall mean each of Licensee, its Affiliates, and their respective sublicensees (which term does not include distributors), as applicable. |
1.47 “Third Party” shall mean an entity other than Lilly and its Affiliates and Licensee and its Related Parties. |
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2.05 Exclusivity. For a period of * * * * following the Effective Date, Lilly shall not, and shall ensure that none of its Affiliates will, either by itself or through collaboration with a Third Party, conduct human clinical studies, manufacture or commercialize anywhere in the Territory any product containing or comprising a selective Transmembrane AMPA Receptor Regulatory Protein (TARP) gamma-8-dependent AMPA Receptor Antagonist (such product, a “Competing Product”). In the event that Lilly acquires, is acquired by or merges with a Third Party that is engaged in active development or commercialization of a Competing Product at the closing of such acquisition or merger, then Lilly shall not be deemed to be in breach of this Section 2.05 with respect to any such Competing Product, and the terms of this Section 2.05 will not apply in any way to limit or restrict, by or on behalf 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 immediately prior to the closing of such acquisition or merger was controlled by such Third Party. |
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hereunder, as applicable. Licensee shall have the discretion to terminate its license under the Third Party License at any time and upon thirty (30) days’ written notice to Lilly provided that Licensee shall be responsible for all Third Party License Expenses due and owing prior to the effective date of such termination and shall be responsible for a proportional share of any subsequent liability to the extent directly resulting from such termination. For purposes of clarity, upon the effective date of such termination, such patent rights and know-how shall not be Lilly Patent Rights or Lilly Know-How. |
2.07 Section 365(n) of the Bankruptcy Code. All rights and licenses granted under or pursuant to any section of this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code. Each Party shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code or equivalent legislation in any other jurisdiction. Upon the bankruptcy of either Party, the other Party shall further be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property, and such, if not already in its possession, shall be promptly delivered to such other Party, unless the Party in bankruptcy elects to continue, and continues, to perform all of its obligations under this Agreement. |
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4.01 Materials and Regulatory Filings Transfer.
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4.02 Transfer of Know-How. Lilly shall, pursuant to Section 4.01(a), transfer to Licensee, or a Third Party manufacturer designated by Licensee, all Lilly Know-How that is reasonably necessary or useful to enable Licensee or its Third Party manufacturer to Manufacture the Licensed Compound or Licensed Product. In addition, as reasonably requested by * * * *.
(a) |
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. |
(b) |
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. |
Pharmacovigilance and Product Complaints.
(a) |
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) |
Licensee shall assume responsibility for maintaining a global safety database for Licensed Product consistent with industry practices. |
(c) |
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. |
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|
Milestone Event |
Amount Due |
The first subject dosed in a Phase 2 Clinical Trial. |
$* * * * |
The first subject dosed in a Phase 3 Clinical Trial. |
* * * * |
Acceptance for filing of an NDA or equivalent for a Licensed Product in the United States |
$* * * * |
NDA approval for a Licensed Product in the United States |
$* * * * |
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|
|
Milestone Event |
Amount Due |
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 $* * * *; and |
· |
* * * * U.S. dollars ($* * * *) at the end of the first calendar year in which aggregate Net Sales for Licensed Products in such calendar year exceeds $* * * *. |
· |
* * * * U.S. dollars ($* * * *) at the end of the first calendar year in which aggregate Net Sales for Licensed Products in such calendar year exceeds $* * * *; and |
· |
* * * * U.S. dollars ($* * * *) at the end of the first calendar year in which aggregate Net Sales for Licensed Products in such calendar year exceeds $* * * *. |
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· |
For the portion of annual worldwide Net Sales for such Licensed Products greater than $* * * * but less than or equal to $* * * *, * * * *; and |
· |
For the portion of annual worldwide Net Sales for such Licensed Products greater than $* * * * but less than or equal to $* * * *, * * * *; and |
· |
For the portion of annual worldwide Net Sales for such Licensed Products greater than $* * * *, * * * *. |
(c) |
Early Generic Product Entry and/or No Lilly Patent Rights. 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 * * * * percent (* * * *%) or more as compared to the two consecutive Calendar Quarters immediately prior to such Generic Product entry (“Generic Competition Threshold”), then the royalty payments due to Lilly for such Licensed Product in such country shall be reduced by * * * * percent (* * * *%). 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. |
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(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. |
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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. |
(a)First Right of Licensee; Right of Lilly to Assume. Licensee shall have the first right, but not the obligation, to bring a suit or otherwise take action against any person or entity directly infringing, contributorily infringing or inducing infringement of the Lilly Patent Rights. If Licensee fails to bring a suit or otherwise take action with respect to infringement of any Lilly Patent Rights within (i) thirty (30) days with respect to potential infringement in the context of a Paragraph IV certification, or (ii) sixty (60) days with respect to potential 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.
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(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 Lilly settle 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.
(c)Recovery. Any recovery obtained by either or both of the Parties in connection with or as a result of any action to enforce any Lilly Patent Rights, whether by settlement or otherwise, shall first be applied to reimburse the costs and expenses of the Party that brought and controlled such action and then to reimburse the costs and expenses of the other Party in connection with such action, and any amounts remaining after such reimbursement shall be retained by the Party that brought and controlled such action, except that if Licensee is the Party that brought and controlled such action, any remaining portion of such recovery that is attributable to lost sales with respect to Licensed Products shall be treated as Net Sales and subject to payment of royalties pursuant to Section 7.03.
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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 * * * *. These obligations shall not apply to Proprietary Information that: |
(a) |
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; |
(c) |
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 |
(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: |
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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. |
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under an agreement or ethical obligation; (b) to a Third Party or Related Party in connection with (i) a financing (or proposed financing) or an equity investment (or proposed investment) in such Party or its Affiliates, including to its shareholders and prospective shareholders, (ii) the granting of a sublicense pursuant to Section 2.04 or entry into any agreement with respect to the development, manufacture or commercialization of a Licensed Product, (iii) a merger, consolidation or similar transaction by such Party or its Affiliates, (iv) the sale of all or substantially all of the assets of such Party or its Affiliates to which this Agreement relates, or (v) in connection with a securitization, provided that such Third Party executes a non-use and non-disclosure agreement with confidentiality and non-use obligations similar to those contained in this Agreement; (c) to the United States Securities and Exchange Commission or any other securities exchange or governmental entity, including as required to make an initial or subsequent public offering, or (d) as otherwise required by law or regulation, provided that in the case of (c) and (d) the disclosing Party shall (x) if practicable, provide the other Party with reasonable advance notice of and an opportunity to comment on any such required disclosure, (y) if requested by such other Party, seek, or cooperate with such Party’s efforts to obtain, confidential treatment or a protective order with respect to any such disclosure to the extent available at such other Party’s expense, and (z) use good faith efforts to incorporate the comments of such other Party in any such disclosure or request for confidential treatment or protective order. |
10.01 Representations and Warranties of Each Party. Each of Lilly and Licensee hereby represents, warrants and covenants to the other Party hereto as follows: |
(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; |
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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. |
10.02 Lilly's Representations. Lilly hereby represents, warrants and covenants to Licensee that as of the Effective Date: |
(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; |
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there are no pending or, to Licensee’s knowledge, threatened judicial, administrative or arbitral actions, claims, suits or proceedings pending as of the Effective Date hereof against Licensee which, to Licensee’s knowledge, either individually or together with any other, would have a material adverse effect on the ability of Licensee to perform its obligations under this Agreement or any agreement or instrument contemplated hereby. |
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Effective Date, including, with respect to the Existing Studies. Notwithstanding the foregoing, Lilly shall have no obligation under this Agreement to indemnify, defend or hold harmless any Licensee Indemnified Party with respect to any Liabilities to the extent that they result from the negligence or willful misconduct of Licensee, Licensee Indemnified Party or any of their respective employees, officers, directors or agents or that result from Licensee's breach of its obligations under this Agreement. |
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This Agreement may be terminated, in its entirety by written notice by either Party at any time during the Term of this Agreement:
12.04 Effect of Termination on License. In the event this Agreement is terminated in accordance with this Agreement, the rights and license granted to Licensee and its Affiliates under Section 2.01 of
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this Agreement shall terminate and all rights to the Licensed Compound and Licensed Product granted under this Agreement shall revert to Lilly, provided that all sublicenses granted under Section 2.04 shall survive to the extent so provided in Section 2.04 herein.
12.05 Effect of Termination Generally; Survival. Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination, and the provisions of Article I (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, Section 12.03(b), Section 12.04, Section 12.05 and Section 12.06, Section 12.07, and Section 12.08 shall survive the expiration or termination of this Agreement. Any expiration or early termination of this Agreement shall be without prejudice to the rights of either Party against the other accrued or accruing under this Agreement prior to termination, including the obligation to pay royalties for Licensed Product sold prior to such termination.
12.06 Licensed Product Reversion. Upon termination of this Agreement in its entirety by Lilly for any reason or by Licensee pursuant to Section 12.02, at Lilly's option and upon Lilly's written request, and at Licensee's expense, the following provisions shall apply:
(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. |
12.07 Termination in Part. In the event that this Agreement is terminated in part with respect to an individual Licensed Product, the terms of Sections 12.04 through 12.06 shall apply accordingly to such terminated Licensed Product, as opposed to termination of the Agreement as a whole.
12.08 Return of Proprietary Information. Not later than thirty days (30) days after the termination of this Agreement in its entirety, each receiving Party shall, at the disclosing Party’s discretion, either
* * * * CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
destroy or return or cause to be returned to the disclosing Party, all Proprietary Information of the disclosing Party in tangible form received from the disclosing Party and any other documents containing the disclosing Party's Proprietary Information, and all copies thereof, including those in the possession of the receiving Party's Agents pursuant to Section 9.01(d), except that the receiving Party may 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.
* * * * CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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. |
(b) |
Each Party shall have the right to be represented by counsel throughout the arbitration proceedings. |
Article XIV - COMPLIANCE WITH ANTI-CORRUPTION LAWS |
14.01 Compliance. In connection with this Agreement, Licensee has complied and will comply with all applicable local, national, and international laws, regulations, and industry codes dealing with government procurement, conflicts of interest, corruption or bribery, including, if applicable, the U.S. Foreign Corrupt Practices Act of 1977 (“FCPA”), as amended, and any laws enacted to implement the Organisation of Economic Cooperation and Development (“OECD”) Convention on Combating Bribery of Foreign Officials in International Business Transactions. |
14.02 Prohibited Conduct. In connection with this Agreement, Licensee has not made, offered, given, promised to give, or authorized, and will not make, offer, give, promise to give, or authorize, any bribe, kickback, payment or transfer of anything of value, directly or indirectly, to any person or to any Government Official for the purpose of: (i) improperly influencing any act or decision of the person or Government Official; (ii) inducing the person or Government Official to do or omit to do an act in violation of a lawful or otherwise required duty; (iii) securing any improper advantage; or (iv) inducing |
* * * * CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
the person or Government Official to improperly influence the act or decision of any organization, including any government or government instrumentality, to assist Licensee or Lilly in obtaining or retaining business. |
15.01 Assignment/Change of Control. |
(a) |
Except as provided in this Section 15.01, 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. Also, notwithstanding anything to the contrary in this Agreement, the obligations under this Section 15.01 shall exclude patent rights and know-how of Lilly that its acquires (through purchase, license or otherwise) or discovers/develops outside the activity of this Agreement after the Effective Date except for the specific patent rights that fall within the specific definition of Lilly Patent Rights and Lilly Know-How. |
(d) |
Any attempted assignment not in accordance with Section 15.01 shall be null and void. |
* * * * CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
15.06 Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States of America that may be imposed upon or related to Lilly or Licensee from time to time by the government of the United States of America. Furthermore, Licensee agrees that it will not export, directly or indirectly, any technical information acquired from Lilly under this Agreement or any Licensed Products using such technical information to any country for which the United States government or any agency thereof at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the Department of Commerce or other agency of the United States government when required by an applicable statute or regulation. |
if to Licensee, to: |
Cerecor Inc. 400 East Pratt Street Baltimore, MD 21202 Attn : John Kaiser or Uli Hacksell jkaiser@cerecor.com or uhacksell@cerecor.com |
* * * * CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
With copy to (which copy shall not constitute notice):
|
Kenneth J. Krisko, Esq. Cooley LLP One Freedom Square Reston Town Center 11951 Freedom Drive Reston, VA 20190-5656 Ph. 703-456-8581 kkrisko@cooley.com |
if to Lilly, to: |
Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285 Attention: General Counsel Fax: 317-433-3000
|
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 15.08.
* * * * CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
the purposes of this Agreement, the Licensee shall be responsible for the contractual obligations of Affiliates. Licensee shall remain fully liable for any acts or omissions of its Affiliates. |
15.13 Captions. The captions of this Agreement are solely for the convenience of reference and shall not affect its interpretation. |
15.15 Signatures. For purposes of this Agreement, signatures sent by facsimile or PDF shall also constitute originals. |
* * * * CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
IN WITNESS WHEREOF, this Agreement has been executed by the duly authorized representatives of the Parties.
ELI LILLY AND COMPANY |
|
CERECOR INC. |
||
By: |
/s/ Jan M. Lundberg |
|
By: |
/s/ Uli Hacksell |
Title: |
Executive Vice President, Science and Technology, and President, Lilly Research Laboratories |
|
Title: |
Chief Executive Officer |
Material Transfer
API Inventory
* * * * |
Lot# |
Inventory |
Unit |
Project ID |
LSN / LY |
* * * * |
* * * * |
* * * * |
GM |
* * * * |
LY3130481 |
|
|
|
|
|
|
Drug product inventory needs to be relabeled before its use in a clinical trial. Cerecor needs to extend the stability study to extend the dating for the drug product.
DP Inventory
Project ID |
WUXI FP No. |
WUXI Batch |
Description |
Inventory |
Warehousing |
* * * * |
* * * * |
* * * * |
* * * * |
* * * * |
27-Mar-14 |
|
* * * * |
* * * * |
* * * * |
* * * * |
27-Mar-14 |
|
* * * * |
* * * * |
* * * * |
* * * * |
27-Mar-14 |
|
* * * * |
* * * * |
* * * * |
* * * * |
9-Apr-14 |
|
|
|
|
|
|
****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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) |
o |
* * * * |
o |
* * * * |
o |
* * * * |
o |
* * * * |
· |
Toxicology reports |
o |
* * * * |
· |
Regulatory documents (some may be in paper) |
o |
* * * * |
· |
CMC |
o |
* * * * |
o |
* * * * |
o |
* * * * |
o |
* * * * |
o |
* * * * |
o |
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o |
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o |
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o |
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o |
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o |
* * * * |
o |
* * * * |
****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
o |
* * * * |
o |
* * * * |
o |
* * * * |
· |
List and copies of draft and final manuscripts/publications |
o |
* * * * |
o |
* * * * |
· |
Presentations and associated files in PowerPoint |
o |
* * * * |
o |
* * * * |
· |
Intellectual Property Materials |
o |
* * * * |
o |
* * * * |
o |
* * * * |
· |
Marketing |
o |
* * * * |
· |
Material Transfer Agreements |
o |
* * * * |
· |
Due Diligence Gaps |
The following are the gaps identified during due diligence review of the data room and is needed as part of tech transfer
o |
CMC Drug Substance Gaps: |
- |
* * * * |
- |
* * * * |
- |
* * * * |
- |
* * * * |
- |
* * * * |
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* * * * |
- |
* * * * |
o |
CMC Drug Product Gaps: |
- |
* * * * |
- |
* * * * |
- |
* * * * |
- |
* * * * |
- |
* * * * |
- |
* * * * |
- |
* * * * |
- |
* * * * |
****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
- |
* * * * |
- |
* * * * |
- |
* * * * |
o |
Non-clinical reports - Need final signed protocol and study reports for the following studies: |
- |
* * * * |
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* * * * |
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* * * * |
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* * * * |
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* * * * |
*Note: Lilly has not confirmed that all items listed in this Schedule 1.28 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 HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Docket Number |
Country |
Application Number |
Application Date |
Patent Number |
Grant Date |
Status |
Sub Status |
* * * * |
A.R.I.P.O. |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
AAAA-Series Summary |
Docketed |
Mailed |
||||
* * * * |
Algeria |
* * * * |
* * * * |
Filed |
Filed |
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* * * * |
Argentina |
* * * * |
* * * * |
Filed |
Published |
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* * * * |
Australia |
* * * * |
* * * * |
Filed |
Case Allowed |
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* * * * |
Brazil |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Brunei |
* * * * |
* * * * |
Filed |
Mailed |
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* * * * |
Canada |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Chile |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
China P.R. |
* * * * |
* * * * |
Filed |
Published |
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* * * * |
Colombia |
* * * * |
* * * * |
Filed |
Published |
||
* * * * |
Costa Rica |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Dominican Republic |
* * * * |
* * * * |
Filed |
Published |
||
* * * * |
Ecuador |
* * * * |
* * * * |
Filed |
Filed |
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* * * * |
Egypt |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
El Salvador |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Eurasian Patent Convention |
* * * * |
* * * * |
Filed |
Published |
||
* * * * |
European Patent Convention |
* * * * |
* * * * |
Filed |
Published |
||
* * * * |
Guatemala |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Gulf Cooperation Council |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Honduras |
* * * * |
* * * * |
Filed |
Filed |
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* * * * |
Hong Kong |
* * * * |
* * * * |
Filed |
Published |
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* * * * |
India |
* * * * |
* * * * |
Filed |
Filed |
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* * * * |
Indonesia |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Israel |
* * * * |
* * * * |
Filed |
Filed |
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* * * * |
Japan |
* * * * |
* * * * |
Filed |
Published |
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* * * * |
Jordan |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Lebanon |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Macao |
Docketed |
Mailed |
||||
* * * * |
Malaysia |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Mexico |
* * * * |
* * * * |
Filed |
Published |
||
* * * * |
Morocco |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
New Zealand |
* * * * |
* * * * |
Filed |
Filed |
****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
* * * * |
Nigeria |
* * * * |
* * * * |
Filed |
Case Allowed |
||
* * * * |
Pakistan |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Panama |
* * * * |
* * * * |
Filed |
Published |
||
* * * * |
Patent Cooperation Treaty |
* * * * |
* * * * |
Inactive |
National |
||
* * * * |
Peru |
* * * * |
* * * * |
Filed |
Published |
||
* * * * |
Philippines |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Korea South |
* * * * |
* * * * |
Filed |
Published |
||
* * * * |
Singapore |
* * * * |
* * * * |
* * * * |
* * * * |
Granted |
Granted |
* * * * |
South Africa |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Sri Lanka |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Taiwan |
* * * * |
* * * * |
Filed |
Published |
||
* * * * |
Thailand |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Trinidad & Tobago |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Tunisia |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
Ukraine |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
United States |
* * * * |
* * * * |
* * * * |
* * * * |
Granted |
Granted |
* * * * |
Venezuela |
* * * * |
* * * * |
Filed |
Published |
||
* * * * |
Vietnam |
* * * * |
* * * * |
Filed |
Filed |
||
* * * * |
AAAA-Series Summary |
Docketed |
Mailed |
||||
* * * * |
Patent Cooperation Treaty |
* * * * |
* * * * |
Filed |
Published |
||
* * * * |
Taiwan |
* * * * |
* * * * |
Filed |
Published |
||
* * * * |
United States |
* * * * |
* * * * |
Filed |
Filed |
****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Attachment 3.02(a)
Development Path for 2016/2017/2018
Technology Transfer:
· |
* * * * |
Non-Clinical:
· |
Write IND summaries |
· |
* * * * |
· |
Plan and conduct 6-month Rat Toxicity Study (2017/2018) |
· |
Plan and conduct 9-month Monkey Toxicity Study (2017/2018) |
· |
Plan and conduct Segment 2 Repro Toxicity Studies (2017/2018) |
Regulatory:
· |
IND development and submission to FDA |
· |
* * * * |
CMC:
· |
Initiate discussion with SynTheAll Pharmaceutical CO., Ltd. (STA), a subsidiary of WuXi AppTec. regarding the product transfer from Lilly to Cerecor |
****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
· |
Re-certify current API and reference standard by 2Q2016 |
· |
Manufacture, package and label CTM using the current API supply for the SAD/MAD studies by 1H2017 |
· |
Write CMC Module 2 and 3 sections of the IND by 2Q2017 |
· |
Manufacture API at STA for preliminary Tox studies by 3Q2-17 |
Clinical:
· |
* * * * |
· |
Write IND summaries |
· |
Finalize Phase 1 SAD/MAD protocols and Phase 2/3 strategy |
· |
* * * * |
· |
Anticipate Phase 1 study start: 2H2017; study end: 1H2018 |
Intellectual Property:
· |
* * * * |
****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
DRAFT – NOT FOR RELEASE
Cerecor Announces Acquisition of Phase 1-ready TARP-γ8-AMPA Receptor Antagonist
(CERC-611) from Lilly
Phase 1 development for epilepsy expected to commence in 2017
BALTIMORE, September 12, 2016 - Cerecor Inc. (NASDAQ: CERC), a clinical-stage biopharmaceutical company developing treatments to make a difference in the lives of patients with neurological and psychiatric disorders, today announced that it has acquired exclusive, worldwide rights from Eli Lilly and Company (“Lilly”) to develop and commercialize LY3130418 (now designated as CERC-611). CERC-611 is a Phase 1-ready, potent and selective Transmembrane AMPA Receptor Regulatory Protein (TARP)-γ8-dependent AMPA receptor antagonist. TARPs are a fairly recently discovered family of proteins that have been found to associate with and modulate the activity of AMPA receptors. TARP-γ8-dependent AMPA receptors are localized primarily in the hippocampus, a region of importance in complex partial seizures and particularly relevant to seizure origination and/or propagation. Research also suggests that selectively targeting individual TARPS may enable selective modulation of specific brain circuits without globally affecting synaptic transmission which may lead to improved efficacy, safety and tolerability. Cerecor expects to submit an investigational new drug application (“IND”) to the United States Food and Drug Administration (“FDA”) and, upon acceptance of the IND by the FDA, commence Phase 1 development of CERC-611 in 2017.
CERC-611 was discovered and developed by Lilly for the treatment of epilepsy, a neurological disorder affecting over 50 million people worldwide, 150,000 new cases are diagnosed in the US annually, and 30-40% of treated patients are resistant to current pharmacotherapies with only 8% of treated patients being maintained seizure free. The disorder, if not controlled can lead to severe pathology and death. “There is a significant unmet need for new mechanisms that provide a new approach to treatment of epilepsy with improved efficacy, safety, tolerability and ease-of-use,” said Ron Marcus, MD, Chief Medical officer and Head, Regulatory Affairs at Cerecor.
AMPA receptor antagonists are known anticonvulsant agents and their ability to modulate excitatory neurotransmission is key to their anti-epileptic therapeutic potential. However, since AMPA receptor activity is so ubiquitous in the central nervous system (“CNS”), a non-selective AMPA antagonist approach affects many areas of the CNS resulting in undesired effects, such as ataxia, sedation, falls, and/or dizziness, which are shared by all known general or broad spectrum AMPA receptor antagonists. Typically, doses of these medications needed to obtain anti-convulsant activity are close to, or overlap with, doses at which undesired effects are observed. “Because of the predominant hippocampal location of TARP-γ8-dependent AMPA receptors, we believe that the efficacy and side effect profile of CERC-611 may represent an improvement compared to current antiepileptics,” said Uli Hacksell, Ph.D., Cerecor’s CEO, President and Chairman. “We are excited to make CERC-611 a key addition to our pipeline and we expect to file an IND and commence Phase 1 clinical in 2017.”
Under the terms of the agreement, Cerecor will immediately assume full development and commercialization responsibilities of CERC-611. Lilly will receive an upfront licensing fee as well as milestone and tiered royalty payments.
About CERC-611
CERC-611 (TARP-γ8-AMPA) is a potent and selective TARP-γ8-dependent AMPA receptor antagonist that we believe is the first molecule to selectively target and functionally block regionally-specific AMPA receptors after oral dosing. This selectivity was engineered into CERC-611 using structure-activity relationship information to achieve selective blockade of the AMPA receptor regulator protein or TARP gamma 8 (γ8) (high density expression in hippocampus, a region of importance in partial epilepsies) while sparing AMPA receptors thought to be associated with TARP‑γ2 (high density expression in cerebellum regulating the ataxia and falling associate with broad spectrum AMPA receptor antagonists).
137782646 v1
CERC-611 has been observed to have positive preclinical activity in multiple animal models of epilepsy, neuropathic pain, and depression.
About Cerecor
Cerecor is a clinical-stage biopharmaceutical company developing innovative drug candidates to make a difference in the lives of patients with neurological and psychiatric diseases. We are committed to the development of drugs that improve lives by applying our extensive knowledge and experience in central nervous system disorders. Cerecor is currently pursuing the development of two clinical Phase 2-stage product candidates: CERC-301 and CERC-501.
CERC-301 as an oral, NR2B specific N‑methyl‑D‑aspartate receptor antagonist that is currently in a Phase 2 clinical trial as an oral, rapidly acting adjunctive treatment for patients with severe major depressive disorder (“MDD”) who are failing to achieve an adequate response to their current antidepressant treatment. We expect top-line data from this trial in the first half of 2017. Cerecor received fast track designation by the United States Food and Drug Administration in November 2013 for CERC‑301 for the treatment of MDD. We believe CERC‑301 has the potential to be a first-in-class medication that may significantly reduce depressive symptoms in a matter of days.
CERC-501 is a potent and selective kappa opioid receptor (“KOR”), antagonist that is currently in a Phase 2 clinical trial for smoking cessation that is expected to provide top-line data in December 2016. In addition to Cerecor’s Phase 2 trial, three externally-funded clinical trials are being conducted to evaluate the use of CERC-501 in treating depressive symptoms, stress related smoking relapse and cocaine addiction. One study is being conducted under the auspices of the National Institute of Mental Health , the second is a collaboration between Cerecor and Yale investigators with funding from the National Institutes of Health funding and the third study is being conducted at Rockefeller University Hospital and is funded by a private foundation.
Cerecor has one preclinical stage asset, CERC-406, a brain penetrant catechol‑O‑methyltransferase inhibitor with potential procognitive activity.
For more information about the Company and its products, please visit www.cerecor.com or contact Mariam E. Morris, Chief Financial Officer, at (443) 304-8002.
Forward-Looking Statements
This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Cerecor’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Cerecor’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions (including their use in the negative), or by discussions of future matters such as the development of product candidates or products, technology enhancements, possible changes in legislation, and other statements that are not historical. These statements are based upon the current beliefs and expectations of Cerecor’s management but are subject to significant risks and uncertainties, including those detailed in Cerecor’s filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Cerecor expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Cerecor’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.
Media Contact:
MacDougall Biomedical Communications
Joe Rayne – 781-235-3060
ir@cerecor.com
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