Contract
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
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. |
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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. |
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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. |
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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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8.4. |
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.
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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. |
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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 000 Xxxxxxxxx Xxxxxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000 (“Licensor”) and Syndax Pharmaceuticals, Inc., a Delaware corporation with a place of business at 00 Xxxxxxxxx Xxxxx, Xxxxxxxx X, Xxxxx 0, Xxxxxxx, Xxxxxxxxxxxxx 00000 (“Licensee”). Licensor and Licensee are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
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.
1.26. |
“Disputes” has the meaning set forth in Section 10.1 (Exclusive Dispute Resolution Mechanism). |
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). |
1.55. |
“Licensee Indemnitee” has the meaning set forth in Section 11.2 (Indemnification by Licensor). |
1.56. |
“Licensor Indemnitee” has the meaning set forth in Section 11.1 (Indemnification by Licensee). |
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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.
1.91. |
“Payment Report” has the meaning set forth in Section 5.6 (Payment Reports; Royalty Payments). |
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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.
1.96. |
“Sublicensing Revenue” means any and all amounts (including upfront payments, milestone payments, and earn-out payments) paid or payable to or received by Licensee or its Affiliates from any Sublicensee or Third Party in consideration for (a) the grant of a sublicense of any of the rights granted to Licensee under this Agreement, or (b) the grant of any option to obtain such a sublicense under any such rights granted to Licensee under this Agreement. Notwithstanding the foregoing, Sublicensing Revenue shall exclude any such payment received by Licensee or any of its Affiliates from any such Third Party in return for, as payment or consideration for, or otherwise in respect of: (i) the [*] of a Licensed Product [*] (e.g., royalties on Net Sales), but for clarity, [*], (ii) equity or debt of Licensee or its Affiliate purchased by such Third Party at or below the fair market value of such equity or debt as of the date of the purchase, (iii) reimbursement of Licensee’s or its Affiliates’ actual cost for [*], (iv) reimbursement [*] for the performance of services by Licensee or its Affiliate, (v) reimbursement of [*], (vi) the sale of Licensee or its Affiliate in whole or in part to a Third Party, unless, at the time of such a sale, [*], or (vii) to the extent that a payment not explicitly tied to a Licensed Product is made under a sublicense agreement that grants rights both to one or more Licensed Products and one or more other products (e.g., an upfront payment), then a pro rata portion of such payment will be considered Sublicensing Revenue which pro rata portion will be calculated 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.
Article 2. |
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2.2.1. |
Right to Sublicense. Licensee will have the right to grant sublicenses, through multiple tiers, of the rights granted to it under Section 2.1 (Exclusive License Grant) to Third Parties (each, a “Sublicensee”) and to its Affiliates, in each case, upon written notice to Licensor (which notice will include [*]); provided that Licensee may only grant a sublicense to a Sublicensee [*] upon [*] (such a [*], a “[*]” and any Sublicensee for which a [*] must be obtained, a “[*]”). If Licensee grants a sublicense [*] to [*], and following the grant of such sublicense, such [*] while retaining its sublicense rights, then thereafter such [*] will be deemed a [*] for purposes of this Agreement and Licensee must obtain a [*] for such [*] in accordance with Section 2.2.2 [*] no later than [*] following the closing of the transaction pursuant to which such [*] ceased to be an [*]. If Licensee does not seek such [*] within such [*] period, or if Licensor does not grant such [*] with respect to such [*] (or is not deemed to have provided such [*]) in accordance with Section 2.2.2 ([*]), then the sublicense granted to such [*] will [*] upon the earlier of: (a) the conclusion of such [*] period, or (b) the date on which Licensor provides notice to Licensee [*] such [*] 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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[*] will be required to obtain another [*] from Licensor in accordance with this Section 2.2.2 ([*]) with respect to such [*]. |
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2.2.3. |
Sublicense Requirements. Licensee will remain responsible for the performance of this Agreement and the performance of its Affiliates and Sublicensees under their sublicensed rights to the same extent as if such activities were conducted by Licensee. Each sublicense to an Affiliate or a Sublicensee of the rights granted to Licensee under Section 2.1 (Exclusive License Grant) will be in writing and will (a) refer to, be subordinate to, and be consistent with this Agreement in all respects; (b) include [*]); (c) require the [*] to [*] if [*] no later than [*] after [*] and require such [*] to [*] to [*]; (d) to the extent required by Applicable Law, require such Affiliate or Sublicensee, upon request, to cooperate in the preparation and prosecution of any Patent Rights included in the Intellectual Property Rights described in subsection (b); and (e) preclude the granting of further sublicenses to the extent inconsistent with this Agreement. Notwithstanding the grant of a sublicense to a Sublicensee, Licensee shall remain fully liable to Licensor under this Agreement, and any sublicense granted hereunder that is inconsistent with this Section 2.2 (Sublicense Rights) will be null and void. |
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2.2.4. |
Copies of Sublicenses. Licensee will furnish to Licensor a true and complete copy of each sublicense agreement with a Sublicensee or an Affiliate and each amendment thereto within [*] after the sublicense or amendment has been executed. Licensee shall be permitted to redact from such copy any portions of the agreement or amendment that are unrelated to Licensed Compounds or Licensed Products or that are not reasonably necessary for Licensor to verify Licensee’s compliance with the terms of this Agreement. |
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2.2.5. |
Continuation of Sublicenses upon Termination of this Agreement. If the license granted to Licensee under Section 2.1 (Exclusive License Grant) terminates, then, each sublicense granted to an Affiliate will automatically and immediately terminate and at the request of any Sublicensee who is not then in breach of its sublicense agreement, Licensor will negotiate in good faith with such Sublicensee to reach agreement on the terms of a direct license to such Sublicensee under the Licensor Technology that is sublicensed to such Sublicensee on substantially the same terms (i.e., terms that provide Sublicensee the same rights and imposes on Sublicensees the same obligations, in each case, as set forth in such sublicense agreement between Licensee and such Sublicensee) effective as of the date of termination of the sublicense agreement granted to Sublicensee by Licensee; provided, however, that (a) such direct license agreement would not impose on Licensor any obligations over and above its obligations under this Agreement, and (b) as consideration for such direct license, the direct license agreement would require Sublicensee to pay Licensor the same amount as Licensee would have received from the applicable Sublicensee (had this Agreement survived) as a result of the Sublicensee’s performance under such sublicense 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.
Article 3. |
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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.
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Review Voucher, then Licensee will convey to Licensor such Priority Review Voucher and [*] (the “[*]”). |
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4.6.1. |
Sale of PRV to a Third Party. Licensee will not be obligated to accept the terms set forth in the PRV Purchase Offer, or to sell to Licensor any Priority Review Voucher; provided that if Licensee elects not to accept the terms set forth in the PRV Purchase Offer, then, unless otherwise agreed in writing by Licensor, Licensee will not [*] the applicable Priority Review Voucher to [*] for [*] that is [*]. For the avoidance of doubt, Licensee shall be free to negotiate with one or more Third Parties with respect to sale of the Priority Review Voucher at all times, even if Licensee elects to submit a PRV Purchase Offer. |
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4.6.2. |
No Sale of PRV. Notwithstanding anything to the contrary set forth in this Agreement, Licensee may use any Priority Review Voucher for the benefit of any of its products (including any Licensed Product), and Licensee will have no obligation to sell to Licensor or any Third Party any Priority Review Voucher. If Licensee elects to use any Priority Review Voucher for the benefit of any product that is not a Licensed Product, then [*] until such time as [*]. |
Article 5. |
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5.3.1. |
Events and Payments. Licensee will notify Licensor as soon as practicable upon (and in any event within [*] Business Days after) achievement of the applicable event listed in Table 5.3.1 below (each, a “Development Milestone Event”) by Licensee or its Affiliate or Sublicensee. Subject to Section 4.6 (Priority Review Vouchers), no later than [*] after receipt of a written invoice from Licensor specifying the achieved Development Milestone Event and the corresponding milestone payment set forth in Table 5.3.1 below (each a “Development Milestone Payment”), Licensee shall pay to Licensor such Development Milestone Payment. For clarity, each Development Milestone Payment will be made only once for the first time that the applicable Development Milestone Event is achieved, regardless of how many Licensed Products may achieve such Development Milestone Event, or how many times a particular Licensed Product may achieve such Development Milestone Event. |
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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.
Table 5.3.1 – Development Milestones |
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[*] |
[*] |
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5.3.3. |
Skipped Payments. If, with respect to any Licensed Product and Indication (as applicable), such Licensed Product achieves any Development Milestone Events in an Indication prior to the achievement of any other earlier-listed Development Milestone Events for the same Indication, then the Development Milestone Payments for such earlier-listed applicable Development Milestone Events for such Licensed Product for such Indication will be due and payable simultaneously with the payment for achievement of such subsequent Development Milestone Event for such Indication, except that (a) [*]; and (b) [*]. For example, if [*], then upon [*], Development Milestone Payment [*] would be due and payable for such Licensed Product for such Indication. |
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5.4.1. |
Events and Payments. Licensee will notify Licensor as soon as practicable (and in any event within [*] Business Days after) when Licensee’s, its Affiliates’, and its Sublicensees’ aggregate Annual Net Sales of all Licensed Products in the Territory in a given Calendar Year first reach the respective thresholds indicated below in Table 5.4.1 below (each, a “Sales Milestone Event”). No later than [*] after receipt of a written invoice from Licensor specifying the achieved Sales Milestone Event and the corresponding one-time milestone payments set forth below Table 5.4.1 below (each, a “Sales Milestone Payment”), Licensee shall pay to Licensor such Sales Milestone Payment. |
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5.4.2. |
Achievement of Multiple Sales Milestones. For clarity, if the Annual Net Sales of all Licensed Products exceeds more than one Sales Milestone Events in Table 5.4.1 above in a given Calendar Year, and had not exceeded any earlier Sales Milestone Event in any prior Calendar Year, then Licensee will pay to Licensor all Sales Milestone Payments due for the achievement of all applicable Sales Milestone Events achieved in such Calendar Year. For example, if in a given Calendar Year, Annual Net Sales of all Licensed Products were $[*] and the Annual Net Sales for Licensed Products 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 $[*]. Similarly, if in a given Calendar Year, Annual Net Sales of all Licensed Product were $[*] and the Annual Net Sales for Licensed Products |
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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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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 $[*]. |
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5.5.1. |
Royalties. Subject to the reductions set forth in Section 5.5.3 (Royalty Reductions), and [*], Licensee will pay to Licensor royalties in the amount of the marginal royalty rates set forth in Table 5.5.1 below on the Annual Net Sales resulting from the sale of all Licensed Products in the Territory during a given Calendar Year (such payments collectively, “Royalties”). |
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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5.5.2. |
Royalty Term. Licensee’s obligation to pay Royalties under this Section 5.5 (Royalty Payments) will continue on a Licensed Product-by-Licensed Product and country-by-country basis until the expiration of the Royalty Term for such Licensed Product in such country (at which time sales in such country will be excluded from all calculations of Annual Net Sales hereunder). |
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5.5.3. |
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(a) |
Third Party IP. If Licensee or any of its Affiliates or permitted Sublicensees enters into an agreement with a Third Party pursuant to which Licensee licenses or acquires rights under any Patent Rights in a given country in the Territory (i) [*], or (ii) [*] (each, a “Third Party License”), then, in each case ((i) and (ii)), subject to the remainder of this Section 5.5.3(a) (Third Party IP), Licensee may deduct [*]% of any payments made under any such Third Party License in a given Calendar Quarter with respect to such country from the Royalties due and payable to Licensor for the applicable Licensed Product in such country made in the same Calendar Quarter. On a country-by-country basis, in no event will the aggregate Royalty amount due to Licensor in any given Calendar Quarter in any country be reduced pursuant to this Section 5.5.3(a) (Third Party IP) by more than [*]% of the amount that otherwise would have been due and payable to Licensor in such Calendar Quarter with respect to such country. On a country-by-country basis, Licensee may carry forward any such Royalty reductions that are incurred or accrued in a Calendar Quarter for a Licensed Product with respect to such country and that are not applied against Royalties for such Licensed Product with respect to such country in such Calendar Quarter as a result of the above reduction floor, and apply such amounts against Royalties for such Licensed Product with respect to such country in any subsequent Calendar Quarter. |
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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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(b) |
Expiration of Valid Claims. Subject to Section 5.5.3(e) (Cumulative Reductions Floor), if during the Royalty Term for a given Licensed Product in a country there is no Valid Claim of any Patent Right that Covers such Licensed Product or the Exploitation of such Licensed Product (or the Licensed Compound contained therein) in such country, then, from the first full Calendar Quarter in which this Section 5.5.3(b) (Expiration of Valid Claims) applies, and thereafter during the remainder of the Royalty Term for such Licensed Product in such country, the aggregate Net Sales of such Licensed Product in such country during each Calendar Quarter will be reduced by [*]%. For clarity, in the event that Section 5.5.3(c) (Loss of Regulatory Exclusivity) and this Section 5.5.3(b) (Expiration of Valid Claims) both apply for a particular Licensed Product and country in a Calendar Quarter, the reduction in aggregate Net Sales of such Licensed Product in such country in such Calendar Quarter will be [*]%. |
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(c) |
Loss of Regulatory Exclusivity. Subject to Section 5.5.3(e) (Cumulative Reductions Floor), if during the Royalty Term for a given Licensed Product in a country there is no Regulatory Exclusivity covering such Licensed Product in such country, then, from the first full Calendar Quarter in which this Section 5.5.3(c) 5.5.4(c) (Loss of Regulatory Exclusivity) applies, and thereafter during the remainder of the Royalty Term for such Licensed Product in such country, the aggregate Net Sales of such Licensed Product in such country during each Calendar Quarter will be reduced by [*]%. For clarity, in the event that Section 5.5.3(b) (Expiration of Valid Claims) and this Section 5.5.3(c) (Loss of Regulatory Exclusivity) both apply for a particular Licensed Product and country in a Calendar Quarter, the reduction in aggregate Net Sales of such Licensed Product in such country in such Calendar Quarter will be [*]%. |
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(d) |
Generic Competition. Subject to Section 5.5.3(e) (Cumulative Reductions Floor), if in any Calendar Year during the Royalty Term for a given Licensed Product in a country the Generic Competition Percentage in such country is greater than or equal to [*]%, then commencing in the next Calendar Year, and thereafter during each Calendar Quarter, the aggregate Net Sales of such Licensed Product in such country during each Calendar Quarter will be reduced by [*]%. |
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(e) |
Cumulative Reductions Floor. On a country-by-country basis, in no event will the aggregate Royalty amount due to Licensor in any given Calendar Quarter in any country be reduced by the reductions set forth in [*] to less than [*]% of the amount that otherwise would have been due and payable to Licensor in such Calendar Quarter with respect to such country, without giving effect to Section 5.5.3(a) (Third Party IP). On a country-by-country basis, Licensee may carry forward any such reductions to the aggregate Net Sales of a Licensed Product with respect to a country permitted under [*] that are incurred or accrued in a Calendar Quarter for such Licensed Product with respect to such country and that are not applied against aggregate Net Sales of such Licensed Product with respect to such country in such Calendar Quarter as a result of the reduction floor set forth in this Section 5.5.3(e) (Cumulative Reductions Floor), and apply such amounts against aggregate Net Sales of such Licensed Product with respect to such country in any subsequent Calendar Quarter. |
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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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5.6.1. |
Payment Obligations. In addition to all other accounts payable to Licensor pursuant to Article 5 (Consideration and Financial Terms), Licensee will pay Licensor, on a Licensed Product by Licensed Product basis, (a) [*]% of all Sublicensing Revenue paid or payable to or received by Licensee or its Affiliates under any sublicense agreement entered into during the period commencing on [*] and continuing until [*], and (b) [*]% of all Sublicensing Revenue paid or payable to or received by Licensee or its Affiliates under any sublicense agreement entered into during the period commencing on [*] and continuing until [*]. Notwithstanding anything to the contrary set forth in this Agreement, if a sublicense agreement grants rights to more than one Licensed Product, then for each applicable Licensed Product that is the subject of such a sublicense agreement, Licensee will pay to Licensor the applicable percentage of Sublicensing Revenue set forth in the foregoing clauses (a) and (b), based on the stage of Development of each such applicable Licensed Product at the time such sublicense agreement is entered into. To the extent that a payment under a sublicense agreement that grants rights to more than one Licensed Product, where the sublicense agreement falls within the scope of clause (a) above with respect to one or more such Licensed Products and within the scope of clause (b) above with respect to one or more other such Licensed Products, cannot be allocated to a Licensed Product (e.g., such as an upfront payment), then such payment will be divided on a pro rata basis based on the number of Licensed Products licensed thereunder with respect to which clause (a) applies and the number of Licensed Products licensed thereunder with respect to which clause (b) applies. |
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5.6.2. |
Other Consideration. If Licensee or its Affiliates receives Sublicensing Revenue or other amounts from Sublicensees or from any person or entity granted any option to obtain a sublicense under this Agreement in the form of non-cash consideration, then, at Licensor’s option, Licensee will pay Licensor (a) payments as required by Section 5.6.1 (Payment Obligation) in the form of the non-cash consideration paid or payable to or received by Licensee or its Affiliates, or (b) a cash payment determined based on the fair market value of such non-cash consideration. If Licensee or its Affiliate enters into any sublicense that is not an arm’s length transaction, then fees due under Section 5.6.1 (Payment Obligation) will be calculated based on the fair market value of such transaction, at the time of the transaction, assuming an arm’s length transaction made in the ordinary course of business, as determined jointly by Licensor and Licensee based on transactions of a similar type and standard industry practice, if any. |
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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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5.11.1. |
General. Each Party is responsible for its own taxes, duties, levies, imposts, assessments, deductions, fees, withholdings, or similar charges imposed on or measured by net income or overall gross income (including branch profits), gross receipts, capital, ability, or right to do business, property, and franchise or similar taxes pursuant to Applicable Law. The development Milestone Payments, Sales Milestone Payments, Royalties, Sublicensing Revenue, and other amounts payable by Licensee to Licensor pursuant to this Agreement (each, a “Payment”) will be paid free and clear of any and all Taxes, except for any withholding or deductions of Taxes required by Applicable Law (“Withholding Taxes”). Licensee will deduct or withhold from the Payments any Withholding Taxes that it is required by Applicable Law to deduct or withhold, and such Withholding Taxes will be treated for all purposes of this Agreement as having been paid to Licensor hereunder. The Parties will reasonably cooperate to minimize any such Withholding Taxes. If Licensor is entitled under Applicable Law or any applicable Tax treaty to a reduction of rate of, or the elimination of, applicable Withholding Tax, then it may deliver to Licensee or the appropriate Governmental Authority (with the reasonable assistance of Licensee to the extent that this is reasonably required and is requested in writing) the prescribed forms, certificates, or other information, valid under Applicable Law, necessary to lawfully reduce the applicable rate of withholding or to relieve Licensee of its obligation to withhold or deduct such Withholding Taxes and Licensee will apply the reduced rate of withholding or dispense with withholding, as the case may be. Notwithstanding the foregoing, Licensee will provide reasonable timely prior notice to Licensor of the intention to deduct or withhold Withholding Taxes from any payment (and the amounts subject to such deduction or withholding, where practicable) to allow Licensor a reasonable opportunity to, or elect to postpone a Payment in order to, timely furnish forms, certificates, or other items that would reduce or eliminate such deduction or withholding in accordance with this Section 5.11.1 (General). If, in accordance with the foregoing, Licensee withholds any amount, then it will pay to Licensor the net remaining balance when due, make timely payment to the proper Governmental Authority of the withheld amount and send to Licensor proof of |
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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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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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5.11.2. |
Value Added Tax. Notwithstanding anything to the contrary set forth in Section 5.11.1 (General), this Section 5.11.2 (Value Added Tax) will apply with respect to VAT. All Payments are exclusive of VAT. If any VAT is required in respect of any Payments under Applicable Law, then Licensee will pay VAT at the applicable rate in respect of any such Payments following the receipt of a valid VAT invoice in the appropriate form issued by Licensor in respect of those Payments, such VAT to be payable on the due date of the payment of the Payments to which such VAT relates. The Parties will reasonably cooperate to issue valid invoices for all amounts due under this Agreement consistent with indirect Tax requirements. The remitting Party will not be responsible for any penalties and interest resulting from the failure by the receiving Party to collect (if not included on a valid invoice) or remit any such VAT. The Parties will reasonably cooperate to report, eliminate, or minimize the amount of any such VAT imposed on the transactions contemplated in 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.
Article 6. |
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6.2.1. |
Prosecution by Licensee. Beginning on Effective Date, and except as otherwise provided in this Section 6.2.1 (Prosecution by Licensee), as between the Parties, Licensee will have the first right and authority to prepare, file, Prosecute, and maintain the Licensor Patent Rights in the Territory. Licensee will bear all costs and expenses of preparation, filing, Prosecution, and maintenance of such Patent Rights in the Territory. Licensee will provide Licensor a reasonable opportunity to review and comment on material communications from any patent authority in the Territory regarding the Licensor Patent Rights, as well as drafts of any material filings or responses to be made to such patent authorities in advance of submitting such filings or responses. Licensee will consider Licensor’s comments regarding such communications and drafts in good faith. In addition, Licensee will provide Licensor with (a) copies of all final material filings and responses made to any Patent Office with respect to the Licensor Patent Rights in a timely manner following submission thereof, and (b) a report each Calendar Year detailing the status of all Licensor Patent Rights that Licensee is Prosecuting or maintaining. |
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6.2.2. |
Prosecution by Licensor. If Licensee determines in its sole discretion to abandon, not to maintain, or not to pursue the Prosecution and issuance of any Licensor Patent Right, then Licensee will provide Licensor with written notice promptly after any such determination to allow Licensor a reasonable period of time to determine, on a country-by-country basis in its sole discretion, its interest in filing, Prosecuting, or maintaining such Patent Right in the Territory (which notice by Licensee will be given no later than 30 days prior to the final deadline for any pending action or response that may be due with respect to such Patent Right with the applicable Patent Office). If Licensor provides written notice to Licensee expressing its interest in maintaining such Licensor Patent Right, then, with respect to such Licensor Patent Right in such country in the Territory, (a) Licensor may, in its sole discretion and at Licensor’s cost and expense, Prosecute and maintain or abandon such Patent Right; (b) such Patent Right will no longer be a Licensor Patent Right for purposes of this Agreement; and (c) Licensee will promptly (i) provide to Licensor or counsel designated by Licensor all files related to filing, Prosecuting, and maintaining such Patent Right, (ii) provide to Licensor a report detailing the status of all Licensor Patent Rights that Licensee is Prosecuting or maintaining as of the applicable date of such notice by Licensee, and (iii) Licensee will provide all assistance reasonably requested by Licensor in Licensor’s Prosecution and maintenance of the applicable Licensor Patent Rights (including by executing all requested documents and providing additional information with respect to the applicable Licensor Patent Rights). |
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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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6.4.1. |
Notification. Each Party will promptly notify the other Party in writing of any existing, alleged, or threatened infringement, misappropriation, or other violation of the Licensor Patent Rights in the Territory of which it becomes aware, and will provide all information in such Party’s possession or Control demonstrating such infringement. |
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6.4.2. |
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(a) |
Licensee Right. Licensee will have the first right, but not the obligation, to bring an appropriate suit or other action against any Third Party engaged in any existing, alleged, or threatened infringement or other violation of any Licensor Patent Right related to [*] (a “Licensed Product Infringement”). Licensor will have the sole right to bring an appropriate suit or other action against any Third Party engaged in any existing, alleged, or threatened infringement or other violation of any Licensor Patent Right. |
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(b) |
Licensor’s Right. Licensee will notify Licensor of its decision as to whether to take any action in accordance with Section 6.4.2(a) (Infringement Action in the Territory; Licensee’s Right) at least [*] Business Days before any time limit set forth in an Applicable Law or regulation, including the time limits set forth under the Xxxxx-Xxxxxx Act (21 U.S.C. § 355) or within [*] after being notified of such Licensed Product Infringement, whichever is shorter. If Licensee decides not to take such action, then Licensee will so notify Licensor in writing, and Licensor will have the second right, but not the obligation, to commence a suit or take action to enforce the applicable Patent Right against such Third Party perpetrating such Licensed Product Infringement in the Territory at its own expense. |
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(c) |
Cooperation. Each Party will provide to the Party enforcing any such rights under this Section 6.4.2 (Infringement of Patent Rights by Third Parties) reasonable assistance in such enforcement, at such enforcing Party’s request and expense, including joining such action as a party plaintiff if required by Applicable Law to pursue such action or providing the enforcing Party any reasonably requested documentation or other materials. The enforcing Party will keep the other Party regularly informed of the status and progress of such enforcement efforts, including providing the other Party a reasonable opportunity to comment on the enforcing Party’s determination of litigation strategy and the filing of important papers to the competent court and the enforcing Party will consider such comments in good faith. If one Party elects to bring suit or take action against the Licensed Product Infringement, then the other Party will have the right, during or prior to commencement of the trial, suit, or action, to join any such suit or action at such Party’s own expense. |
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(d) |
Expenses. Subject to Section 6.4.2(f) (Allocation of Proceeds), the enforcing Party will be solely responsible for all expenses arising from a suit or action against a Licensed Product Infringement. For the avoidance of doubt, the enforcing Party will not be responsible for the other Party’s internal expenses (e.g., FTEs) incurred as a result of the other Party’s cooperation with the enforcement action as provided |
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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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(e) |
Settlement. Neither Party will settle any claim, suit, or action that it brought under this Section 6.4.2 (Infringement Actions in the Territory) that could reasonably be expected to affect the other Party’s rights or interests without the prior written consent of the other Party, which consent will not be unreasonably withheld. |
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(f) |
Allocation of Proceeds. If either Party recovers monetary damages from any Third Party in a suit in the Territory pursuant to this Section 6.4.2 (Infringement Actions) or any royalties from a license agreement with a Third Party related to any alleged Licensed Product Infringement, whether or not such damages or royalties result from the infringement of Licensor Patent Rights, such recovery will be allocated first to the reimbursement of any expenses incurred by each Party in such litigation, action, or license, and any remaining amounts will be [*]. |
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7.1.1. |
General. Each Party (the “Receiving Party”) will maintain all Confidential Information disclosed to it by the other Party (the “Disclosing Party”) in strict confidence during the Term of this Agreement and for a period of five years after the expiration or termination of |
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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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7.1.2. |
Confidential Information of Each Party. All Licensor Know-How will be the Confidential Information of Licensor, notwithstanding whether it would otherwise be included in any of the exceptions set forth in Section 7.1.3 (Exceptions to Confidentiality). The contents of each report provided pursuant to Section 4.4 (Development Reporting) and Section 4.5 (Commercialization Reporting), and each Payment Report will be considered Confidential Information of each Party, and, in each case, will remain subject to the rights and obligations of the Parties under this Article 7 (Confidentiality). The non-disclosed terms of this Agreement will be the Confidential Information of each Party. |
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7.1.3. |
Exceptions to Confidentiality. Except with respect to the Licensor Know-How, each report provided pursuant to Section 4.4 (Development Reporting) and Section 4.5 (Commercialization Reporting), and each Payment Report, the obligations of each Receiving Party imposed by Section 7.1.1 (General) will not apply to any Confidential Information disclosed to the Receiving Party by the Disclosing Party that: (a) was known to the Receiving Party without an obligation to keep such information confidential prior to the Effective Date other than as a result of disclosure under any other agreement between the Parties (as demonstrated by competent evidence); (b) is or becomes generally available to the public through means other than an unauthorized disclosure by the Receiving Party, its Affiliates, or any agents to whom it or they disclosed such information; (c) was or subsequently is disclosed to the Receiving Party without restriction by a Third Party having a bona fide right to disclose such Confidential Information without breaching any obligation to the Disclosing Party; (d) is developed independently by the Receiving Party without benefit of or recourse to any of the Disclosing Party’s Confidential Information (as demonstrated by competent evidence); or (e) is publicly published pursuant to Section 7.1.4 (Permitted Disclosures). |
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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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7.1.4. |
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(a) |
Compliance with Law. Notwithstanding anything to the contrary set forth in this Article 7 (Confidentiality), each Receiving Party may make disclosures of Confidential Information of the Disclosing Party (i) to Patent Offices in any country in which Patent Rights are sought for purposes of Prosecuting any applications for Patent Rights or defending any Patent Rights in interference or opposition actions as contemplated by this Agreement; (ii) to Regulatory Authorities as necessary to pursue Development, Commercialization, or Regulatory Approval of Licensed Products; or (iii) to the extent required to comply with Applicable Law or a court or administrative order; provided, however, that the Party who is required to make such disclosure (A) provides the other Party with reasonable prior written notice if permissible under Applicable Law, (B) coordinates with the other Party with respect to the wording and timing of any such disclosure and affords the Disclosing Party an opportunity to oppose or limit, or secure confidential treatment for such required disclosure, (C) if the Disclosing Party is unsuccessful in its efforts pursuant to clause (B), takes all reasonable and lawful actions to obtain confidential treatment for such disclosure, and (D) discloses the minimum amount and scope of the Confidential Information necessary to comply with any such Applicable Law or such court or administrative order. Any Confidential Information so disclosed will still be subject to the terms of this Agreement. |
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(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.
Article 8. |
8.1. |
Mutual Representations and Warranties. Each of the Parties hereby represents and warrants to the other Party as of the Effective Date that: |
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8.1.1. |
Organization. It is a corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement. |
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8.1.2. |
Binding Agreement. This Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or equity). |
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8.1.3. |
Authorization. The execution, delivery, and performance of this Agreement by such Party have been duly authorized by all necessary corporate action and do not conflict with any agreement, instrument, or understanding, oral or written, to which it is a party or by which it is bound, nor violate any Applicable Law or any order, writ, judgment, injunction, decree, determination, or award of any court or governmental body, or administrative or other agency presently in effect applicable to such Party. |
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8.1.4. |
No Further Approval. It is not aware of any material government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any Applicable Law, currently in effect, necessary for, or in connection with, the transactions contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements (save for Regulatory Approvals and similar authorizations from Regulatory Authorities necessary for the Exploitation of the Licensed Compounds and Licensed Products as contemplated hereunder). |
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8.1.5. |
No Inconsistent Obligations. Neither Party is under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement, or that would impede the diligent and complete fulfillment of its obligations hereunder. |
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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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8.2.1. |
Sufficient Rights. Licensor is the sole owner of the Licensor Technology, free of any encumbrance, lien, or claim of ownership by any Third Party, and has all rights necessary to grant the rights and licenses under the Licensor Technology that it purports to grant to Licensee in this Agreement. |
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8.2.2. |
Licensor Patent Rights. To Licensor’s Knowledge, Schedule 1.59 sets forth all Patent Rights owned or licensed by Licensor or its Affiliates, or to which Licensor or its Affiliates otherwise have rights, that Cover a Licensed Compound or a Licensed Product or the Exploitation thereof in the Field or that are necessary for such Exploitation as contemplated as of the Effective Date. All such Patent Rights are subsisting, and to Licensor’s Knowledge, valid and enforceable. No written claim or litigation has been brought or asserted against Licensor or its Affiliates or with respect any such Patent Right (and to Licensor’s Knowledge, no such claims have been threatened) by any Person (a) alleging the invalidity, misuse, unregisterability, unenforceability, or non-infringement of any such Patent Rights, or (b) challenging Licensor’s ownership or control of any such Patent Rights The pending applications included in such Patent Rights are being prosecuted using reasonable efforts in the respective Patent Offices in the Territory in accordance with Applicable Law and Licensor and its Affiliates have presented all material references, documents and information of which it and the inventors are aware to the relevant patent examiner at the relevant Patent Office, and all such Patent Rights have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment, as required under Applicable Law. To Licensor’s Knowledge, each of such Patent Rights properly identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such patent is issued or such patent application is currently pending. True, complete, and correct copies of the file wrappers, and to the extent in the possession or control of Licensor or its Affiliates or their respective counsel, other non-privileged or non-work-product documents and materials relating to the Prosecution, defense, or maintenance of such Patent Rights have been provided or made available to Licensee. |
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8.2.3. |
Licensor Know-How. To Licensor’s Knowledge, there is no Know-How owned by, or otherwise in the possession or control of, Licensor or any of its Affiliates as that relates to the Licensed Compounds or the Licensed Products that is not included in the Licensor Know-How. Licensor has used reasonable efforts to preserve the confidentiality of trade secrets in the Licensed Know-How. |
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8.2.4. |
Third Party Infringement. There is no claim pending by Licensor alleging that a Third Party is or was infringing, misappropriating, or otherwise violating the Licensor Technology in the Territory in the Field, and, to Licensor’s Knowledge, no Third Party is infringing the Licensor Technology. |
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8.2.5. |
No Infringement. To Licensor’s Knowledge, the Exploitation of [*] or other Licensed Compounds or Licensed Products (where the active ingredient includes only Licensed Compounds) as contemplated under the Development Plan as of the Effective Date does not violate, infringe, or constitute misappropriation of or otherwise conflict or interfere with any Patent Rights or Know-How of any Third Party. There is no action or other proceeding duly filed and served against Licensor or any of its Affiliates, nor, to Licensor’s Knowledge, threatened against Licensor or any of its Affiliates alleging that 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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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. |
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8.2.6. |
No Conflicting Rights. Neither Licensor nor any of its Affiliates has previously entered into any agreement, whether written or oral, with respect to or otherwise assigned, transferred, licensed, conveyed, granted any right or forbearance with respect to, or otherwise encumbered its right, title or interest in or to the Licensor Technology, or any Patent Right or Know-How that would be Licensor Technology but for such assignment, transfer, license, conveyance, right, forbearance or encumbrance and it will not enter into any such agreements, grant any such right, title or interest to any person or entity that, in each case, is inconsistent with or otherwise diminish the rights and licenses granted to Licensee under this Agreement. |
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8.2.7. |
No Other Payments. To Licensor’s Knowledge, there are no amounts that will be required to be paid to a Third Party or any inventor of the Licensor Patent Rights (including under any applicable inventor remuneration laws) under any agreement to which Licensor or any of its Affiliates is a party, as a result of the Development, Manufacture, or Commercialization of the Licensed Compounds or Licensed Products as contemplated under the Development Plan as of the Effective Date. |
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8.2.8. |
No Government Funding. Neither Licensor nor any of its Affiliates have been a party to any agreement with the United States federal government or an agency thereof pursuant to which the United States federal government or such agency provided funding for the Development of the Licensed Compounds or Licensed Products (to the extent that a Licensed Compound is the only active ingredient), and the inventions claimed or covered by the Licensor Patent Rights are not subject to the provisions of the Patent and Trademark Law Amendments Act of 1980, as amended, codified at 35 U.S.C. §§ 200-212, as amended, or any regulations promulgated pursuant thereto, including in 37 C.F.R. Part 401. |
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8.2.9. |
Compliance. Licensor and its Affiliates, contractors, and consultants have conducted all Development activities with respect to the Licensed Compounds and Licensed Products in accordance with good clinical practice, good laboratory practice, good manufacturing practice, as applicable, and all other Applicable Laws. |
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8.2.10. |
No Debarment. To Licensor’s Knowledge, neither Licensor nor any of its Affiliates has been debarred by the FDA, and are not subject to any similar sanction of other Regulatory Authorities in the Territory, and to Licensor’s Knowledge, neither Licensor nor any of its Affiliates has used, in any capacity, in connection with this Agreement, any Person who either has been debarred by such a Regulatory Authority, or is the subject of a conviction described in Section 306 of the FFDCA, in each case, except to the extent that would not be material to this Agreement or the Licensed Technology, Licensed Compounds, or Licensed Products. |
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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.
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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. |
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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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8.3.2. |
No Debarment. Neither Licensee nor any of its Affiliates or Sublicensees will engage, in any capacity, in connection with this Agreement, any Person who either has been debarred by such a Regulatory Authority, or is the subject of a conviction described in Section 306 of the FFDCA. Licensee will inform Licensor in writing promptly if it or any Person engaged by Licensee or any of its Affiliates or Sublicensees who is performing any activities under or in connection with this Agreement is debarred or is the subject of a conviction described in Section 306 of the FFDCA, or if any action, suit, claim, investigation, or legal or administrative proceeding is pending or, to Licensee’s knowledge, is threatened, relating to the debarment or conviction of Licensee, any of its Affiliates or Sublicensees, or any such Person performing activities. |
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8.3.3. |
Anti-Corruption. Licensee will comply 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, in connection with the activities conducted pursuant to this Agreement. Licensee will require any contractors, Subcontractors, distributors, or other Person that provide services to Licensee in connection with this Agreement to comply with Licensee’s obligations under this Section 8.3.3 (Anti-Corruption). |
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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.
8.5. |
No Other Warranties. EXCEPT AS EXPRESSLY STATED IN THIS Article 8 (REPRESENTATIONS, WARRANTIES, AND COVENANTS), NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OR CONDITIONS OF ANY KIND, EITHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING WARRANTIES OF TITLE, NON-INFRINGEMENT, VALIDITY, ENFORCEABILITY, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE LICENSOR MATERIALS, LICENSED COMPOUNDS, LICENSED PRODUCTS, THE LICENSOR TECHNOLOGY, OR THE SUBJECT MATTER OF THIS AGREEMENT. ANY INFORMATION PROVIDED BY LICENSOR OR ITS AFFILIATES IS MADE AVAILABLE ON AN “AS IS” BASIS WITHOUT WARRANTY WITH RESPECT TO COMPLETENESS, COMPLIANCE WITH REGULATORY STANDARDS OR REGULATIONS OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER KIND OF WARRANTY WHETHER EXPRESS OR IMPLIED. |
Article 9. |
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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9.7.1. |
Reversion of Rights. All Licensed Compounds and Licensed Products and all rights related thereto will revert to Licensor, including all rights under the Licensor Technology, and Licensor will have the right, in its sole discretion, to Exploit all Licensed Compounds and Licensed Products in the Field throughout the Territory. |
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9.7.2. |
Termination of Rights and Obligations. Subject to this Section 9.7 (Effects of Termination) and Section 9.10 (Survival), all other rights and obligations of the Parties under this Agreement will terminate. |
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9.7.3. |
Assignment of Regulatory Submissions. Licensee will and hereby does, and will cause its Affiliates and its Sublicensees to, (a) effective as of the effective date of termination, assign to Licensor all of its rights, title, and interests in and to all Clinical Trial data, Regulatory Submissions, and Regulatory Approvals applicable to any Licensed Compounds or Licensed Products and then owned or otherwise Controlled by Licensee or any of its Affiliates or its Sublicensees, and (b) to the extent assignment pursuant to clause (a) is delayed or is not permitted by the applicable Regulatory Authority, permit Licensor to cross-reference and rely upon any Clinical Trial data, Regulatory Submissions, and Regulatory Approvals filed by Licensee or its Affiliates or Sublicensees with respect to any Licensed Product. Licensee will take all reasonable steps necessary to transfer, or will cause its Affiliates and Sublicensees to transfer, ownership of all such assigned Regulatory Submissions and Regulatory Approvals to Licensor, including submitting to each applicable Regulatory Authority a letter or other necessary documentation (with a copy to Licensor) notifying such Regulatory Authority of the transfer of such ownership of each Regulatory Submission or Regulatory Approval. |
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9.7.4. |
License Grant to Licensor. Licensee will and hereby does, and will cause its Affiliates and its Sublicensees to, effective as of the effective date of termination, grant to Licensor an exclusive, fully paid-up, royalty-bearing (in accordance with Section 9.7.5 (Royalty to Licensee)), worldwide, transferable, perpetual, and irrevocable license and right of reference, with the right to sublicense through multiple tiers, in and to any and all (a) Regulatory Submissions and Regulatory Approvals applicable to any Licensed Compounds or Licensed Products and owned or otherwise Controlled by Licensee or its Affiliates or Sublicensees as of the effective date of termination that are not assigned 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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9.7.5. |
Royalty to Licensee. Licensor will pay to Licensee royalties on the Net Sales of each Licensed Product in the Territory during the applicable Royalty Term for such Licensed Product in each country, which royalties will be (a) [*]% of Net Sales for each Licensed Product with respect to which the effective date of such termination occurs after [*] for such Licensed Product, but prior to [*], and (b) [*]% of Net Sales for each Licensed Product with respect to which the effective date of such termination occurs after [*]. In such case, the applicable terms of the definition of Net Sales, the definition of Royalty Term, Section 5.5 (Royalty Payments), Section 5.7 (Payment Reports), Section 5.8 (Other Payments), Section 5.9 (No Refunds; Offsets), Section 5.10 (Exchange Rate), Section 5.11 (Taxes), Section 5.12 (Audit), and Section 5.13 (Manner of Payment; Late Payment) will apply mutatis mutandis with Licensor or its Affiliates and sublicensees as the Party selling the Licensed Products and making payments. On a Licensed Product-by-Licensed Product and |
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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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9.7.6. |
Patent Information. Licensee, if requested in writing by Licensor, will provide (a) any and all material correspondence with the relevant Patent Offices pertaining to the Licensee’s prosecution of any Licensor Patent Rights to the extent not previously provided to Licensor during the course of the Agreement, and (b) a report detailing the status as of the effective date of termination of all Licensor Patent Rights that Licensee is Prosecuting or maintaining, and all Patent Rights included in the Licensee Grantback Technology. |
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9.7.7. |
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(a) |
Transfer to Licensor. Unless expressly prohibited by any Regulatory Authority, at Licensor’s written request, Licensee will and hereby does, and will cause its Affiliates, and its Sublicensees to, transfer control of all Clinical Trials involving any Licensed Products being conducted by or on behalf of Licensee, an Affiliate, or a Sublicensee as of the effective date of termination to Licensor or its Affiliates or a Third Party that is designated in writing by Licensor. Licensee will continue to conduct such Clinical Trials, at Licensor’s cost, until such transfer is completed in order to enable such transfer to be completed without interruption of any such Clinical Trial (including the assignment of all related Regulatory Submissions, Regulatory Approvals, and investigator and other agreements relating to such Clinical Trials); provided that Licensor will not have any obligation to continue any Clinical Trial unless required by Applicable Law or under the terms of any agreement relating to such Clinical Trial that Licensor agrees to assume. Licensor will pay all out-of-pocket costs incurred by either Party to complete such Clinical Trials if Licensor requests that such Clinical Trials be completed. |
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(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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9.7.8. |
Licensee Knowledge Transfer; Inventory. Licensee will provide all knowledge transfer and other training to Licensor or its designated Affiliate or Third Party as reasonably necessary for Licensor or such designated Affiliate or Third Party to Exploit the Licensed Compounds and Licensed Products. In connection with such transfer, Licensee will, at Licensor’s option in its sole discretion, at the end of any post-termination Commercialization period pursuant to Section 9.7.10 (Further Sales) (a) transfer 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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9.7.9. |
Selected Third Party Agreements. At Licensor’s written request, Licensee will, and cause its Affiliates and its Sublicensees to, assign to Licensor any Selected Third Party Agreement related to any Licensed Compounds or Licensed Products requested by Licensor, unless any Selected Third Party Agreement expressly prohibits such assignment, in which case Licensee (or such Affiliate or Sublicensee, as applicable) will cooperate with Licensor in all reasonable respects to secure the consent of the applicable Third Party to such assignment. If any such consent cannot be obtained with respect to a Selected Third Party Agreement, then Licensee will, and cause its Affiliates and its Sublicensees to, obtain for Licensor substantially all of the practical benefit and burden under such Selected Third Party Agreement, including by (a) entering into appropriate and reasonable alternative arrangements on terms agreeable to each of Licensor and Licensee (or such Affiliate or Sublicensee, as applicable), and (b) subject to the consent and control of Licensor, enforcing, at Licensor’s cost and expense and for the account of Licensor, any and all rights of Licensee (or such Affiliate or Sublicensee, as applicable) against the other party thereto arising out of the breach or cancellation thereof by such other party or otherwise. Notwithstanding the foregoing, Licensee’s obligations under this Section 9.7.9 (Selected Third Party Agreement) will not apply to any Selected Third Party Agreements that are necessary for Licensee to exercise its continuing right to sell the Licensed Products pursuant to Section 9.7.10 (Further Sales) until the expiration of such rights (at which time the obligations under this Section 9.7.9 (Selected Third Party Agreement) will apply). |
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9.7.10. |
Further Sales. If this Agreement is terminated for any reason other than termination by Licensor for Licensee’s material breach pursuant to Section 9.4 (Termination for Cause) or by Licensor for a Challenge pursuant to Section 9.5 (Termination for Patent Challenges), then for a period of up to [*] after the effective date of such termination, (a) Licensee or its Affiliate or Sublicensee will have the continued right to sell the Licensed Products in such country from its inventory and the obligation to comply with the terms of this Agreement in connection with such Commercialization, and (b) Licensee’s and its Affiliates’ and Sublicensees’ obligations under this Agreement with respect to all such Licensed Product that Licensee or its Affiliates or Sublicensees sell, including the obligation to remit Royalties to Licensor hereunder, will continue in full force and effect during such period. |
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9.7.11. |
Appointment as Exclusive Distributor. If any Licensed Products are being Commercialized by Licensee in any country in the Territory as of the effective date of termination, then, at Licensor’s election (in its sole discretion) on a country-by-country basis in the Territory, subject to Licensee’s continuing right to Commercialize pursuant to Section 9.7.10 (Further Sales), until such time as all Regulatory Approvals (where |
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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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9.7.12. |
Supply of Product. At Licensor’s written request, Licensee will continue to use commercially reasonable efforts to manufacture or cause to be manufactured and to supply or cause to be supplied to Licensor such quantities of Licensed Compounds and Licensed Products (in bulk drug substance, bulk drug product, or finished drug product form, in each case to the extent Licensee manufactures or has manufactured such form(s) at the time of termination) as Licensor indicates in written forecasts and orders therefor from time-to-time at Licensee’s actual cost of goods for such Licensed Compounds and Licensed Products plus [*]%, until the earliest of (a) such time as Licensor has established an alternate, validated source of supply for such Licensed Compounds and Licensed Products, and Licensor is receiving supply from such alternative source, (b) [*] following the effective date of termination of this Agreement and (c) if, at the time of such termination, the manufacture of Licensed Compounds and Licensed Products is being conducted by Third Party manufacturers on Licensee’s behalf and all such agreements with such Third Parties can be assigned to Licensor (in whole or, if such agreements relate to products other than Licensed Products, in relevant part) and Licensor requests such assignment of such agreements, upon such assignment to Licensor of all such agreements. Licensor acknowledges and agrees that the terms under which Licensee manufactures and supplies Licensed Compounds and Licensed Products to Licensor hereunder will be subject to then existing terms and conditions of Licensee’s agreements with its manufacturers and suppliers. |
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9.7.13. |
Trademark License. Effective as of the date of termination, Licensee hereby grants and agrees to grant to Licensor a fully paid-up, royalty-free, worldwide, transferable, sublicensable (through multiple tiers), perpetual, and irrevocable license to use the Trademarks owned or otherwise Controlled by Licensee solely identifying each Licensed Product (which will not include any of Licensee’s housemarks) for the purpose of Commercializing the Licensed Product. In addition, during the period commencing on the effective date of termination of this Agreement and continuing until the date upon which (a) all Regulatory Approvals have been assigned to Licensor, and (b) the applicable Regulatory Authorities in each country in the Territory have approved, and Licensor (or its designee) is prepared to Commercialize the Licensed Products under, new packaging and labeling bearing Licensor’s housemarks (or its designees’ housemarks) and branding for each Licensed Product, Licensee hereby grants and agrees to grant to Licensor a fully paid-up, royalty-free, worldwide, transferable, sublicensable (through multiple tiers) license to use any Licensee housemarks and branding that, as of the effective date of termination of this Agreement, are included on the packaging and labeling of any Licensed Product for the purpose of Commercializing the Licensed Products, provided that Licensor complies |
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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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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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9.7.14. |
Further Assistance. Licensee will, and will cause its Affiliates and Sublicensees to, provide any other assistance or take any other actions, in each case reasonably requested by Licensor, as necessary to transfer to Licensor the Exploitation of the Licensed Compounds and Licensed Products, and will execute all documents as may be reasonably requested by Licensor in order to give effect to this Section 9.7 (Effects of Termination). |
Article 10. |
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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 11. |
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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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11.3.1. |
Notice. Promptly after a Licensor Indemnitee or a Licensee Indemnitee (each, an “Indemnitee”) receives notice of a pending or threatened Claim, such Indemnitee will give written notice of the Claim to the Party from whom the Indemnitee is entitled to receive indemnification pursuant to Section 11.1 (Indemnification by Licensee) or Section 11.2 (Indemnification by Licensor), as applicable (the “Indemnifying Party”). However, an Indemnitee’s delay in providing or failure to provide such notice will not relieve the Indemnifying Party of its indemnification obligations, except to the extent it can demonstrate prejudice due to the delay or lack of notice. |
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11.3.2. |
Defense. Upon receipt of notice under Section 11.3.1 (Notice) from the Indemnitee, the Indemnifying Party will have the duty to either compromise or defend, at its own expense and by counsel (reasonably satisfactory to Indemnitee), such Claim. The Indemnifying |
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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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11.3.3. |
Cooperation. The Indemnitee will cooperate fully with the Indemnifying Party and its legal representatives in the investigation and defense of any Claim. The Indemnifying Party will keep the Indemnitee informed on a reasonable and timely basis as to the status of such Claim (to the extent the Indemnitee is not participating in the defense of such Claim) and conduct the defense of such Claim in a prudent manner. |
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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 12. |
If to Licensor:
Vitae Pharmaceuticals, Inc.
Xxxxxx Corporate Center III
000 Xxxxxxxxx Xxxxxxx
Xxxxxxxxxx, XX 00000
Attention: General Counsel
Facsimile: (000) 000-0000
Copy to:
Allergan, Inc.
Xxxxxx Corporate Center III
000 Xxxxxxxxx Xxxxxxx
Xxxxxxxxxx, XX 00000
Attention: General Counsel
Facsimile: (000) 000-0000
Copy to (which will not constitute notice):
Ropes & Xxxx LLP
000 Xxxxxxxx Xxxxxx; Prudential Tower
Xxxxxx, XX 00000
Attention: Xxxx X. Xxxxxxxxxx
Facsimile: (000) 000-0000
If to Licensee:
00 Xxxxxxxxx Xxxxx, Xxxxxxxx X, Xxxxx 0
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.
12.2. |
Non-Solicit. Licensee, without the prior written consent of Licensor, during the Term, will not solicit, induce, encourage, or participate in soliciting, inducing, or encouraging any employee of Licensor, or any of its Affiliates, in each case who have been [*] in the [*] prior to [*], to terminate his or her relationship with Licensor or Licensor’s Affiliate and accept employment with Licensee. An offer of employment to an employee of Licensor by Licensee which results directly from unsolicited responses to general advertisements for employment or from an unsolicited inquiry by such employee will not be a violation of this provision. |
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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. |
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SYNDAX PHARMACEUTICALS, INC. |
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By: |
/s/ A. Xxxxxx X. Xxxxxx |
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By: |
/s/ Xxxx X. Xxxxxxxx |
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Name: A. Xxxxxx X. Xxxxxx |
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Name: Xxxx X. Xxxxxxxx |
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Title: President |
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Title: General Counsel & Corporate Secretary |
ALLERGAN, INC. (Solely for the purposes of [*]) |
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By: |
/s/ A. Xxxxxx X. Xxxxxx |
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Name: A. Xxxxxx X. Xxxxxx |
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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.