CONFIDENTIAL
Execution Version
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Exhibit 10.47
License Agreement
By and Between
Vitae Pharmaceuticals, Inc.
and
Syndax Pharmaceuticals, Inc.
______________________________________
Dated as of October 13, 2017
______________________________________
Page
Article 1. | Definitions1 |
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Article 2. | LICENSE GRANT14 |
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| 2.1. | Exclusive License Grant14 |
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| 2.2. | Sublicense Rights14 |
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| 2.3. | Subcontractors16 |
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| 2.4. | Retained Rights16 |
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Article 3. | TRANSFER ACTIVITIES16 |
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| 3.1. | Licensed Compound and Transfer16 |
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| 3.2. | Licensor Materials Disclaimer17 |
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| 3.3. | Contact Persons17 |
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Article 4. | DEVELOPMENT, MANUFACTURING, AND COMMERCIALIZATION18 |
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| 4.1. | General Responsibilities18 |
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| 4.2. | Diligence Obligations18 |
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| 4.3. | Development Plan18 |
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| 4.4. | Development Reporting18 |
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| 4.5. | Commercialization Reporting19 |
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| 4.6. | Priority Review Voucher19 |
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Article 5. | CONSIDERATION AND FINANCIAL TERMS20 |
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| 5.1. | Upfront Payment20 |
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| 5.2. | Reimbursement of Patent Expenses20 |
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| 5.3. | Development Milestones20 |
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| 5.4. | Sales Milestones22 |
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| 5.5. | Royalty Payments23 |
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| 5.6. | Income from Sublicensees25 |
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| 5.7. | Payment Reports; Payments26 |
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| 5.8. | Other Payments26 |
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| 5.9. | No Refunds; Offsets27 |
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| 5.10. | Exchange Rate27 |
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| 5.11. | Taxes27 |
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| 5.12. | Audit28 |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Article 6. | INTELLECTUAL PROPERTY RIGHTS28 |
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| 6.1. | Ownership28 |
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| 6.2. | Prosecution of Patent Rights29 |
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| 6.3. | Patent Term Extensions29 |
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| 6.4. | Infringement of Patent Rights by Third Parties29 |
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| 6.5. | Patent Challenges31 |
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| 6.6. | Common Interest31 |
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Article 7. | CONFIDENTIALity31 |
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| 7.1. | Confidential Information31 |
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| 7.2. | Publicity33 |
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| 7.3. | Publications33 |
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| 7.4. | No Use of Name34 |
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Article 8. | REPRESENTATIONS, WARRANTIES, AND COVENANTS34 |
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| 8.1. | Mutual Representations and Warranties34 |
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| 8.2. | Additional Representations and Warranties of Licensor35 |
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| 8.3. | Licensee Covenants. Licensee covenants to Licensor that:37 |
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| 8.4. | No False Statements37 |
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| 8.5. | No Other Warranties38 |
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Article 9. | TERM; TERMINATION38 |
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| 9.1. | Term38 |
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| 9.2. | Mutual Termination. This Agreement may be terminated by written agreement of each Party38 |
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| 9.3. | Termination at Will38 |
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| 9.4. | Termination for Cause38 |
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| 9.5. | Termination for Patent Challenges38 |
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| 9.6. | Termination for an Insolvency Event39 |
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| 9.7. | Effects of Termination39 |
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| 9.8. | Accrued Rights44 |
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| 9.9. | No Waiver45 |
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| 9.10. | Survival45 |
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Article 10. | DISPUTE RESOLUTION45 |
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| 10.1. | Exclusive Dispute Resolution Mechanism45 |
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| 10.2. | Resolution by Executive Officers45 |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
| 10.4. | Jurisdiction45 |
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| 10.5. | Injunctive Relief46 |
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| 10.6. | Waiver of Right to Jury Trial46 |
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Article 11. | INDEMNIFICATION; INSURANCE46 |
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| 11.1. | Indemnification by Licensee46 |
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| 11.2. | Indemnification by Licensor46 |
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| 11.3. | Indemnification Procedures47 |
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| 11.4. | Settlement48 |
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| 11.5. | Insurance48 |
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Article 12. | Miscellaneous48 |
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| 12.1. | Notice48 |
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| 12.2. | Non-Solicit49 |
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| 12.3. | Designation of Affiliates49 |
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| 12.4. | Assignment49 |
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| 12.5. | Limitation of Liability50 |
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| 12.6. | Severability50 |
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| 12.7. | Waiver and Non-Exclusion of Remedies50 |
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| 12.8. | Relationship of the Parties50 |
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| 12.9. | No Third Party Beneficiaries50 |
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| 12.10. | Construction; Rules of Construction51 |
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| 12.11. | Governing Law51 |
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| 12.12. | Entire Agreement51 |
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| 12.13. | Counterparts51 |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
This License Agreement (this “Agreement”) is made effective as of October 13, 2017 (the “Effective Date”) by and between Vitae Pharmaceuticals, Inc., a Delaware corporation with a place of business at 400 Interpace Parkway, Parsippany, New Jersey 07054 (“Licensor”) and Syndax Pharmaceuticals, Inc., a Delaware corporation with a place of business at 35 Gatehouse Drive, Building D, Floor 3, Waltham, Massachusetts 02451 (“Licensee”). Licensor and Licensee are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, Licensor Controls certain Patent Rights, Know-How, and other Intellectual Property Rights related to the Licensed Compound; and
WHEREAS, Licensee wishes to obtain, and Licensor desires to grant, a license under certain Patent Rights, Know-How, and other Intellectual Property Rights Controlled by Licensor to Exploit the Licensed Compounds and Licensed Products on the terms and conditions set forth herein.
NOW, THEREFORE, the Parties agree as follows:
1.4. | “Allergan” means Allergan, Inc., a Delaware corporation. |
1.5. | “Annual Net Sales” means, with respect to a given Calendar Year, the aggregate amount of Net Sales for all Licensed Products in all countries in the Territory for such Calendar Year. |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
1.8. | “[*]” means [*]. |
1.9. | “Business Day” means a day other than a Saturday or Sunday or a day on which banking institutions in New York, New York are permitted or required to be closed. |
1.16. | “Combination Product” means a Licensed Product that is comprised of or contains a Licensed Compound as an active ingredient together with one (1) or more other active ingredients and is sold either as a fixed dose/unit or as separate doses/units in a single package. |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
1.18. | “Commercially Reasonable Efforts” means, with respect to Licensee’s obligations under the Agreement to Exploit the Licensed Compounds and Licensed Products, the level of efforts in carrying out such obligation in a sustained manner that is at least consistent with the efforts that a similarly situated biotechnology company would typically devote to compounds and products of similar commercial and scientific potential at a similar stage in their lifecycle, based on market conditions then prevailing and taking into account expected and actual cost and time to Exploit the Licensed Compounds and Licensed Products, the potential profitability of the Licensed Compounds and Licensed Products, the competitiveness of the marketplace, the performance of other products that are of similar market potential, the likely timing of other products’ entry into the market and all other relevant legal and technical factors. The expenditure of Commercially Reasonable Efforts requires, with respect to a particular task or activity in Exploiting the Licensed Compounds and Licensed Products, that Licensee: [*]. The expenditure of Commercially Reasonable Efforts requires Licensee to [*] given the commercial and scientific potential of the Licensed Compounds and Licensed Products, and [*] for purposes of determining Licensee’s expenditure of Commercially Reasonable Efforts. |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
1.29. | “Executive Officer” has the meaning set forth in Section 10.2 (Resolution by Executive Officers). |
1.30. | “Exploit” means, in respect of a compound, product, or material, to make, have made, import, use, sell, or offer for sale, including to research, Develop, Commercialize, register, seek Regulatory Approval for, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), have used, export, transport, distribute, promote, market, or have sold or otherwise dispose of such compound, product, or material. When used as a verb, “Exploit” and “Exploiting” means to engage in Exploitation and “Exploited” has a corresponding meaning. |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
1.32. | “FDASIA” means the Food and Drug Administration Safety and Innovation Act, as amended from time-to-time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto). |
1.33. | “FFDCA” means the Federal Food, Drug and Cosmetic Act under United States Code, Title 21, as amended from time-to-time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto). |
1.36. | “GAAP” means United States generally accepted accounting principles, consistently applied. |
1.37. | “Generic Competition Percentage” means, on a Licensed Product-by-Licensed Product and country-by-country basis, total aggregate [*] of the applicable Generic Product sold in a Calendar Year in such country divided by the sum of: (a) total aggregate [*] of the applicable Licensed Product sold in such Calendar Year in such country, and (b) total aggregate [*] of such Generic Product sold in such Calendar Year in such country, where, in each case ((a) and (b)), the total aggregate [*] of a Licensed Product and each Generic Product will be based on [*]. |
1.38. | “Generic Product” means, with respect to a given Licensed Product in a given country, any pharmaceutical product sold by a Third Party (other than as a Sublicensee) in such country that: (a) contains the [*], (b) is approved by the applicable Regulatory Authority in such country for [*], and (c) is [*] by the applicable Regulatory Authority in such country [*]. |
1.40. | “ICH” means International Conference on Harmonization. |
1.44. | “Independent Prices” has the meaning set forth in Section 1.68 (Net Sales). |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
1.45. | “Indication” means the use of a pharmaceutical product for the treatment, prevention, cure, or control of a specific human disease, disorder, illness, or condition |
1.48. | “Know-How” means all technical and scientific information, knowledge, technology, experimental protocols and procedures, methods, processes, practices, formulae, instructions, skills, techniques, procedures, ideas, concepts, designs, drawings, specifications, data, results, and other materials, including all physical, chemical, and biological materials, (together, in each case, with all improvements to any of the foregoing). |
1.52. | “Licensed Product Infringement” has the meaning set forth in Section 6.4.2(a) (Licensee Right). |
1.54. | “Licensee Grantback Technology” has the meaning set forth in Section 9.7.4 (License Grant to Licensor). |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
1.60. | “Licensor Technology” means collectively, (a) Licensor Patent Rights, and (b) Licensor Know-How. |
1.66. | “Mono Product” has the meaning set forth in Section 1.68 (Net Sales). |
Notwithstanding anything to the contrary set forth in this Agreement, amounts received or invoiced by Licensee or its Affiliates or Sublicensees for the sale of such Licensed Product among Licensee or its Affiliates or Sublicensees for resale will not be included in the computation of Net Sales hereunder. In any event, any amounts received or invoiced by
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Licensee or its Affiliates or Sublicensees will be accounted for only once. For purposes of determining Net Sales, a Licensed Product will be deemed to be sold when invoiced. Net Sales will be determined and accounted for in accordance with GAAP. A particular deduction may only be accounted for once in the calculation of Net Sales.
If consideration other than cash is paid to Licensee, its Affiliates, or any Sublicensees, then for purposes of determining Net Sales, the Parties will use the cash consideration that Licensee, its Affiliates, or any Sublicensees would realize from an unrelated buyer in an arm’s length sale of an identical item sold in the same quantity and at the time and place of the transaction, as determined jointly in good faith by Licensor and Licensee based on transactions of a similar type and standard industry practice, if any.
In the event that the Licensed Product is sold as part of a Combination Product, then:
(a)subject to (b) and (c) below, 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 by the fraction, A / (A+B) where A is the wholesale acquisition cost charged by Licensee or its Affiliates or Sublicensees in such period and country for a Licensed Product containing the Licensed Compound(s) in the Combination Product as its sole active ingredients (the “Mono Product(s)”), if such Mono Product is sold separately by Licensee or its Affiliates or Sublicensees in such period and country (the “Independent Price(s)”), and B is the wholesale acquisition cost charged by Licensee or its Affiliates or Sublicensees product(s) containing as their sole active ingredient(s) those active ingredients that are not Licensed Compounds included in the Combination Product (“Other Product(s)”) if such Other Product(s) are sold separately by Licensee or its Affiliates or Sublicensees in such period and country, in each case for a quantity comparable to that used in such Combination Product and of substantially the same class, purity and potency or functionality, as applicable; provided that if any of such Other Product(s) are not sold separately by Licensee or its Affiliates or Sublicensees, but are independently marketed by one or more Third Parties, in such period and country, then such product(s) shall be deemed to be separately sold by Licensee or its Affiliates or Sublicensees at the average wholesale acquisition costs charged by such Third Parties for purposes of the calculations in this paragraph; or
(b)if the calculation in subsection (a) cannot be made because the Other Products are not sold separately by Licensee or its Affiliates or Sublicensees in such period and country for a quantity comparable to that used in such Combination Product and of substantially the same class, purity and potency or functionality, as applicable, 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 by the fraction, A / C where A is the Independent Price for a Mono Product, and C is the wholesale acquisition cost charged by Licensee or its Affiliates or Sublicensees for the Combination Product; or
(c)if the calculation of Net Sales resulting from a Combination Product cannot be determined by either of the foregoing methods, Net Sales for such Combination Product shall be calculated based upon the relative value of the active components of such Combination Product as reasonably determined by the Parties in good faith.
1.70. | “Other Products” has the meaning set forth in Section 1.68 (Net Sales). |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
| [*] will be required to obtain another [*] from Licensor in accordance with this Section 2.2.2 ([*]) with respect to such [*]. |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
to redact any information not related to the Licensed Compounds and Licensed Products, and to discuss such records and documents with such Licensor Vendors. |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
| Review Voucher, then Licensee will convey to Licensor such Priority Review Voucher and [*] (the “[*]”). |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
| had not totaled $[*] in any other prior Calendar Year, then Licensee would make a one- time payment to Licensor under this Section 5.4 (Sales Milestones) of $[*]. |
Each marginal royalty rate set forth in Table 5.5.1 above will apply only to that portion of the Annual Net Sales of Licensed Products in the Territory during a given Calendar Year that falls within the indicated range.
For example, if the aggregate Net Sales of the Licensed Products in the Territory in a given Calendar Year totaled $[*], then Licensee would pay to Licensor [*].
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
5.8. | Other Payments. Licensee will pay to Licensor any other amounts due under this Agreement within [*] following receipt of invoice therefor. |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
| such payment within a reasonable time following such payment. If Licensee takes any actions that would increase any required Withholding Taxes that otherwise would not be required absent such action, including a Change of Control, change in tax residence, sublicense, or assignment of this Agreement by law or otherwise, then Licensee will increase Payments such that after such additional deduction and withholding, Licensor receives the amount it would have received had no such deduction or withholding been made. |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
such patent term extension, including any Third Party expenses incurred by Licensor in furtherance of such filing. |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
| (b) | SEC Filings and Other Disclosures. Either Party may disclose the terms of this Agreement only to the extent required, in the reasonable opinion of such Party based on advice of legal counsel, to comply with the rules and regulations promulgated by the United States Securities and Exchange Commission or similar security regulatory authorities in other countries. If a Party must disclose this Agreement or any of the terms hereof in accordance with the preceding sentence, then such Party agrees, at its own cost and expense, to (a) provide the other Party with reasonable prior notice of such disclosure, (b) coordinate with the other Party with respect to the wording and timing of any such disclosure and afford the other Party an opportunity to request that the disclosing Party seek confidential treatment of certain portions or terms of this Agreement, and (c) seek confidential treatment of portions of this Agreement or such terms as may be reasonably requested by the other Party. |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
8.1. | Mutual Representations and Warranties. Each of the Parties hereby represents and warrants to the other Party as of the Effective Date that: |
| 8.1.6. | No Conflicts. The execution, delivery and performance of this Agreement by such Party does not conflict with such Party’s charter documents, bylaws, or other organizational documents, any material agreement, instrument, or understanding, oral or written, to which it is a party or by which it is bound, nor violate Applicable Law or any order, writ, decree, judgment, injunction, determination, or award of any Governmental Authority having jurisdiction over it. |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
8.2. | Additional Representations and Warranties of Licensor. Except as set forth in Schedule 8.2, Licensor represents and warrants as of the Effective Date to Licensee that: |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
| Development, Manufacture, or Commercialization of any Licensed Compounds or Licensed Product or use of Licensor Know-How as contemplated herein violates, infringes, constitutes misappropriation, or otherwise conflicts or interferes with any Intellectual Property Right of any Third Party. There are no judgments, orders, writs, injunctions, decrees, awards, or settlements against or owed by Licensor or any of its Affiliates or to which Licensor or any of its Affiliates is a party or, to Licensor’s Knowledge, any actions, or claims threatened, in each case, relating to the Licensor Technology, Licensed Compounds, or Licensed Products. |
| 8.2.11. | Anti-Corruption. Licensor its Affiliates, and their respective officers, directors, employees, and to Licensor’s Knowledge, each of Licensor’s and its Affiliates’ |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
| representatives, agents, or other Persons acting on behalf of Licensor or its Affiliates have complied with all Applicable Laws concerning bribery, money laundering, or corrupt practices or which in any manner prohibit the giving of anything of value to any official, agent, or employee of any government, political party, or public international organization, candidate for public office, health care professional, or to any officer, director, employee, or representative of any other organization specifically including the U.S. Foreign Corrupt Practices Act, and the UK Bribery Act, in each case, except to the extent that would not be material to this Agreement or the Licensed Technology, Licensed Compounds, or Licensed Products. |
| 8.3.1. | Compliance with Law. Licensee will, and will ensure all Third Parties that it engages, comply with all Applicable Laws with respect to the performance of its obligations under this Agreement. |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
9.3. | Termination at Will. Licensee may terminate this Agreement at will, in its sole discretion, in its entirety on not less than [*] prior written notice to Licensor. |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Challenge, Licensor may bring any action against Licensee in any forum of competent jurisdiction of Licensor’s choosing. |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
| 9.7.7. | Ongoing Clinical Trials. |
| (b) | Licensee Wind-Down. If Licensor does not elect to assume control of any such Clinical Trials, then Licensee will responsibly wind-down any on-going Clinical Trials of Licensed Products for which it has responsibility hereunder in which patient dosing has commenced, in each case, in accordance with Applicable Law, accepted pharmaceutical industry norms, ethical practices, and regulatory requirements associated with discontinuing any Clinical Trial, which norms, practices, or requirements may require Licensee to continue (and not wind-down) a Clinical Trial for a Licensed Product. In addition, in such case, Licensee will maintain the IND during any such wind-down period until the completion of the wind-down of all Clinical Trials of Licensed Products, unless the IND has been inactivated. In addition, Licensee will be responsible for any out-of-pocket costs associated with such wind-down. |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
| with any and all use guidelines applicable to such housemarks and branding that are provided by Licensee from time to time; and provided further, that Licensee shall only use such Licensee housemarks and branding pursuant to this Section for so long as is reasonably necessary for Licensor to ensure a smooth transition of commercialization of the Licensed Product and to comply with Applicable Law, and Licensor shall use reasonable efforts to convert the packaging and labeling of Licensed Product to Licensor’s housemarks and branding as soon as practical following termination of this Agreement, consistent with Licensor’s Commercialization needs and Applicable Law. |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
If to Licensor:
Vitae Pharmaceuticals, Inc.
Morris Corporate Center III
400 Interpace Parkway
Parsippany, NJ 07054
Attention: General Counsel
Facsimile: (862) 261-7923
Copy to:
Allergan, Inc.
Morris Corporate Center III
400 Interpace Parkway
Parsippany, NJ 07054
Attention: General Counsel
Facsimile: (862) 261-7923
Copy to (which will not constitute notice):
Ropes & Gray LLP
800 Boylston Street; Prudential Tower
Boston, MA 02199
Attention: Marc A. Rubenstein
Facsimile: (617) 235-0706
If to Licensee:
35 Gatehouse Drive, Building D, Floor 3
Copy to:
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
remaining provisions hereof. The Parties will make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized. |
12.12. | Governing Law. This Agreement was prepared in the English language, which language will govern the interpretation of, and any Dispute regarding, the terms of this Agreement. This |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Agreement and all Disputes arising out of or related to this Agreement or any breach hereof will be governed by and construed under the laws of the State of New York, without giving effect to any choice of law principles that would require the application of the laws of a different state. |
{Signature Page Follows}
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
IN WITNESS WHEREOF, duly authorized representatives of the Parties have duly executed this Agreement as of the Effective Date.
VITAE PHARMACEUTICALS, INC. |
| SYNDAX PHARMACEUTICALS, INC. | ||
By: | /s/ A. Robert D. Bailey |
| By: | /s/ Luke J. Albrecht |
| Name: A. Robert D. Bailey |
|
| Name: Luke J. Albrecht |
| Title: President |
|
| Title: General Counsel & Corporate Secretary |
ALLERGAN, INC. (Solely for the purposes of [*]) | |
By: | /s/ A. Robert D. Bailey |
| Name: A. Robert D. Bailey |
| Title: President |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Licensor Patent Rights
FR Ref. No. | Application Number | Filing Date | Jurisdiction |
[*] | [*] | [*] | [*] |
[*] = One page of confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Licensed Compound Inventory
Compound Name | BATCH | Amount | Units |
[*] | [*] | [*] | [*] |
[*] = One page of confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Other Materials
[*]
[*] = One page of confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Development Plan
[*]
[*] = One page of confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Patent Expenses
[*]
[*] = One page of confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Disclosure Schedule
[*]
[*] = One page of confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.