Document:

aimt-ex105_775.htm

 

Exhibit 10.5(b)

AIMMUNE THERAPEUTICS, INC.

 

SECURITIES PURCHASE AGREEMENT

This Securities Purchase Agreement (“Agreement”) is made as of November 11, 2018 (the “Effective Date”), between Aimmune Therapeutics, Inc., a Delaware corporation (the “Company”), and Nestle Health Science US Holdings, Inc., a Delaware corporation (the “Purchaser”). 

AGREEMENT

In consideration of the mutual covenants contained in this Agreement, and for other good and valuable consideration, the receipt of which is hereby acknowledged, the Company and the Purchaser hereby agree as follows:

SECTION 1.AUTHORIZATION OF SALE OF SECURITIES.

The Company has authorized the sale and issuance to the Purchaser of 3,237,529 shares of its Common Stock, par value $0.0001 per share (the “Common Stock”), on the terms and subject to the conditions set forth in this Agreement.  The shares of Common Stock sold hereunder at the Closing (as defined below) shall be referred to as the “Shares.”  

SECTION 2.AGREEMENT TO SELL AND PURCHASE THE SHARES.

At the Closing (as defined in Section 3), the Company will sell to Purchaser, and Purchaser will purchase from the Company the Shares at a purchase price of $30.27 per Share for an aggregate purchase price of $98,000,002.83 (the “Aggregate Purchase Price”).

SECTION 3.CLOSING AND DELIVERY.

3.1Closing.  Subject to the terms and conditions set forth herein, the closing of the purchase and sale of the Shares pursuant to this Agreement (the “Closing”) shall be held on the date (the “Closing Date”) that is three (3) business days following the satisfaction of the conditions precedent set out in Sections 6 and 7 hereof at the offices of Latham & Watkins LLP, 140 Scott Drive, Menlo Park, California 94025, or on such other date and place as may be agreed to by the Company and the Purchaser.  At the Closing, the Purchaser shall pay the Aggregate Purchase Price to the Company in accordance with Section 6.1, and each of the Purchaser and the Company shall execute and deliver to the other, each of the agreements or other documents required to be executed by it as of the Closing Date pursuant to this Section 3 and Sections 6 and 7 hereof.

3.2Issuance of the Securities at the Closing.  At the Closing, the Company shall issue or deliver to the Purchaser evidence of a book entry position evidencing the Shares purchased by the Purchaser hereunder, registered in the name of the Purchaser, or in such nominee name(s) as designated by the Purchaser, representing the Shares to be purchased by the Purchaser at the Closing against payment of the purchase price for the Shares.  The name(s) in 

 

 

 

 

 

 

which the shares are to be issued to the Purchaser is set forth in the Purchaser Questionnaire in the form attached hereto as Appendix I (the “Purchaser Questionnaire”), as completed by the Purchaser, which shall be provided to the Company no later than the Closing Date. 

3.3Delivery of the Registration Rights Agreement.  As of the Effective Date, the Company and the Purchaser shall have executed and delivered the Amended and Restated Registration Rights Agreement in the form attached hereto as Appendix III (the “Registration Rights Agreement”), with respect to the registration of the Shares under the Securities Act of 1933, as amended (the “Securities Act”). In connection with such Registration Rights Agreement, the Purchaser (or the Holder(s) (as defined in the Registration Rights Agreement)), shall deliver to the Company, concurrently with the written request to the Company as contemplated by Section 2(a) thereof, the Selling Stockholder Notice and Questionnaire in the form attached hereto as Appendix II (the “Selling Stockholder Questionnaire”).

3.4Delivery of the Collaboration Agreement.  As of the Effective Date, the Company and the Purchaser shall have executed and delivered the Amended and Restated Collaboration Agreement in the form attached hereto as Appendix IV (the “Collaboration Agreement”).  

3.5Delivery of Standstill Agreement.  As of the Effective Date, the Company and the Purchaser shall have executed and delivered the Amended and Restated Standstill Agreement, in form attached hereto as Appendix V (the “Standstill Agreement”), pursuant to which, among other things, the Purchaser will agree to certain restrictions on the acquisition or disposition of Company securities.

SECTION 4.REPRESENTATIONS, WARRANTIES AND COVENANTS OF THE COMPANY.

Except as set forth on the Schedule of Exceptions delivered to the Purchaser concurrently with the execution of this Agreement (the “Schedule of Exceptions”) or as otherwise described in the SEC Documents (as defined below), which disclosures qualify these representations and warranties in their entirety, the Company hereby represents and warrants as of the date hereof to, and covenants with, the Purchaser as follows:

4.1Organization and Standing.  The Company (i) is a corporation duly organized, validly existing and in good standing under the laws of Delaware, with full corporate power and authority to own or lease, as the case may be, and to operate its properties and conduct its business as presently conducted, and (ii) is duly qualified to do business as a foreign corporation and is in good standing under the laws of each jurisdiction which requires such qualification, except in the case of clause (ii) above, to the extent that the failure to be so qualified or be in good standing would not reasonably be expected to result in a material adverse effect on the condition (financial or otherwise), earnings, business, properties or prospects of the Company and its subsidiaries, taken as a whole (a “Material Adverse Effect”).  

4.2Subsidiaries.  Each “significant subsidiary” of the Company (as such term is defined in Rule 1-02 of Regulation S-X) (each, a “Subsidiary” and, collectively, the “Subsidiaries”) (i) has been duly organized and is validly existing in good standing under the 

2

 

 

 

 

 

 

laws of the jurisdiction of its incorporation or organization, has corporate or similar power and authority to own, lease and operate its properties and to conduct its business as presently conducted, and (ii) is duly qualified to transact business and is in good standing in each jurisdiction in which such qualification is required, whether by reason of the ownership or leasing of property or the conduct of business,  except in the case of clause (ii) above, to the extent that the failure to be so qualified or be in good standing would not reasonably be expected to result in a Material Adverse Effect. All of the issued and outstanding capital stock of each Subsidiary has been duly authorized and validly issued, is fully paid and nonassessable and is owned by the Company, directly or through subsidiaries, free and clear of any security interest, mortgage, pledge, lien, encumbrance, claim or equity. The only Subsidiaries of the Company are the subsidiaries listed in Section 4.2 of the Schedule of Exceptions. 

4.3Corporate Power; Authorization.  The Company has all requisite corporate power and authority, and has taken all requisite corporate action, to execute and deliver this Agreement, the Registration Rights Agreement, the Collaboration Agreement and the Standstill Agreement (collectively, the “Transaction Documents”), sell and issue the Shares and carry out and perform all of its obligations under the Transaction Documents.  Each Transaction Document constitutes, or when executed and delivered in accordance with the terms hereof, will constitute, the legal, valid and binding obligation of the Company, enforceable in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws relating to or affecting the enforcement of creditors’ rights generally, (ii) as limited by equitable principles generally and (iii) as rights to indemnity or contribution may be limited by state or federal laws or public policy underlying such laws (collectively, the “Enforceability Limitations”).

4.4Issuance and Delivery of the Shares.  The Shares have been duly authorized and, when issued and paid for in compliance with the provisions of this Agreement, will be validly issued, fully paid and nonassessable,  and will be free and clear of any security interests, liens or other encumbrances created by or on behalf of the Company (other than restrictions on transfer under applicable securities laws).  Assuming the accuracy of the representations made by the Purchaser in Section 5, the offer and issuance by the Company of the Shares is exempt from registration under the Securities Act. 

4.5SEC Documents; Financial Statements.  The Company has filed in a timely manner all documents that the Company was required to file with the Securities and Exchange Commission (the “Commission”) under Sections 13, 14(a) and 15(d) the Securities Exchange Act of 1934, as amended (the “Exchange Act”), since becoming subject to the requirements of the Exchange Act.  As of their respective filing dates (or, if amended prior to the date of this Agreement, when amended), all documents filed by the Company with the Commission (the “SEC Documents”) complied in all material respects with the requirements of the Exchange Act and the rules and regulations of the Commission promulgated thereunder.  None of the SEC Documents as of their respective dates contained any untrue statement of material fact or omitted to state a material fact required to be stated therein or necessary to make the statements made therein, in light of the circumstances under which they were made, not misleading.  The consolidated financial statements of the Company and its subsidiaries included in the SEC Documents (the “Financial Statements”) present fairly the financial condition, results of operations and cash flows of the Company on a consolidated basis as of the dates and for the 

3

 

 

 

 

 

 

periods indicated, comply as to form with the applicable accounting requirements of the Exchange Act and have been prepared in conformity with United States generally accepted accounting principles applied on a consistent basis throughout the periods involved (except as otherwise noted therein). KPMG, LLP, who have certified certain financial statements of the Company delivered their report with respect to the audited consolidated financial statements and schedules included in the SEC Documents, are independent public accountants with respect to the Company within the meaning of the Exchange Act and the applicable published rules and regulations thereunder.  

4.6Capitalization.  The authorized capital stock of the Company consists of 250,000,000 shares of Common Stock and 10,000,000 shares of undesignated preferred stock, par value $0.0001 per share, of the Company (“Preferred Stock”).  As of November 5, 2018, there are no shares of Preferred Stock issued and outstanding and there are 58,764,877 shares of Common Stock issued and outstanding, of which no shares are owned by the Company.  There are no other shares of any other class or series of capital stock of the Company issued or outstanding.  All of the issued and outstanding shares of Common Stock have been duly authorized and validly issued and are fully paid and non-assessable.  The Company has no capital stock reserved for issuance, except that, as of the November 5, 2018, there are (i) 11,932,917 shares of Common Stock reserved for issuance pursuant to the Company’s stock incentive plans, of which 7,234,532 shares are issuable upon the exercise of stock options outstanding on the date hereof, 337,438 shares are issuable upon vesting of restricted stock units outstanding on the date hereof and 4,360,947 shares of Common Stock reserved for issuance pursuant to future awards under the Company’s stock incentive plans and (ii) 1,799,242 shares of Common Stock reserved for issuance pursuant to the Company’s employee stock purchase plan.  There are no bonds, debentures, notes or other indebtedness having general voting rights (or convertible into securities having such rights) (“Voting Debt”) of the Company issued and outstanding.  Except as stated above, there are no existing options, warrants, calls, subscriptions or other rights, agreements, arrangements or commitments relating to the issued or unissued capital stock of the Company, obligating the Company to issue, transfer, sell, redeem, purchase, repurchase or otherwise acquire or cause to be issued, transferred, sold, redeemed, purchased, repurchased or otherwise acquired any capital stock or Voting Debt of, or other equity interest in, the Company or securities or rights convertible into or exchangeable for such shares or equity interests or obligations of the Company to grant, extend or enter into any such option, warrant, call, subscription or other right, agreement, arrangement or commitment.  The issuance of the Shares pursuant to this Agreement will not give rise to any preemptive rights or rights of first refusal on behalf of any third-party.  Other than the Amended and Restated Investors’ Rights Agreement, dated January 20, 2015, by and among the Company and the parties listed therein (as amended to date), and the Registration Rights Agreement, there are no agreements or arrangements under which the Company or any of its subsidiaries is obligated to register the sale of any of their securities under the Securities Act. 

4.7Litigation.  Except as set forth in Section 4.7 of the Schedule of Exceptions or the SEC Documents, no action, suit, investigation or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any of its subsidiaries or any of its or their property or any officer or director of the Company in their capacity as such (collectively, “Actions”), is pending or, to the best knowledge of the Company, threatened, which if adversely determined will have a Material Adverse Effect, whether or not arising from transactions in the ordinary course of business. There is no Action pending, or to the 

4

 

 

 

 

 

 

Company’s best knowledge threatened, which if adversely determined could materially and adversely effect the Company’s ability to consummate the transactions contemplated by the Transaction Documents.

4.8Governmental Consents.  No consent, approval, order or authorization of, or registration, qualification, designation, declaration or filing with, any federal, state, or local governmental authority on the part of the Company is required in connection with the consummation of the transactions contemplated by the Transaction Documents, except as contemplated by Section 6.4 and for (a) the filing of a Form D with the Commission under the Securities Act and compliance with applicable securities and blue sky laws in the jurisdictions in which Shares are offered and/or sold, which compliance will be effected in accordance with such laws, (b) the approval by The Nasdaq Global Select Market of the listing of the Shares and (c) the filing of one or more registration statements and all amendments thereto with the Commission as and when contemplated by the Registration Rights Agreement.

4.9No Default or Consents.  Neither the execution, delivery or performance of the Transaction Documents by the Company nor the consummation of any of the transactions contemplated thereby (including, without limitation, the issuance and sale by the Company of the Shares) will conflict with, result in a breach or violation of, or imposition of any lien, charge or encumbrance upon any property or assets of the Company or any of its subsidiaries pursuant to, (i) the charter or by-laws of the Company, (ii) the terms of any indenture, contract, lease, mortgage, deed of trust, note agreement, loan agreement or other agreement, obligation, condition, covenant or instrument to which the Company or any of its subsidiaries is a party or bound or to which its or their property is subject, including the Material Agreements (defined below) or (iii) any statute, law, rule, regulation, judgment, order or decree applicable to the Company or any of its subsidiaries of any court, regulatory body, administrative agency, governmental body, arbitrator or other authority having jurisdiction over the Company or any of its subsidiaries or any of its or their property, except in the case of clauses (ii) and (iii) above, for any conflict, breach or violation of, or imposition that would not, individually or in the aggregate, have a Material Adverse Effect. 

4.10No Material Adverse Change.  Since September 30, 2018: (i) there has been no event, occurrence or development that has had or that could reasonably be expected to have a Material Adverse Effect; (ii) there have not been any changes in the authorized capital, assets, liabilities, financial condition, business, Material Agreements or operations of the Company and its subsidiaries, taken as a whole, from that reflected in the Financial Statements, except for any such changes in the ordinary course of business which have not had or would not reasonably be expected to have, either individually or in the aggregate, materially adverse to the business, properties, financial condition or results of operations of the Company and its subsidiaries, taken as a whole and (iii) the Company has not declared or made any dividend or distribution of cash or other property to its stockholders (other than repurchases of unvested shares of Common Stock in connection with the cessation of service by employees or consultants of the Company).

4.11No General Solicitation.  None of the Company, any of its subsidiaries or any Person acting on its or their behalf, has engaged in any form of general solicitation or general advertising (within the meaning of Regulation D promulgated under the Securities Act) in connection with the offer or sale of the Shares.  

5

 

 

 

 

 

 

4.12No Integrated Offering.  None of the Company, any of its subsidiaries or any Person acting on its or their behalf has, directly or indirectly, made any offers or sales of any security or solicited any offers to buy any security of the Company or any of its subsidiaries, under circumstances that would adversely affect reliance by the Company on Section 4(a)(2) of the Securities Act or require registration of any of the Shares under the Securities Act or cause this offering of the Shares to be integrated with prior offerings by the Company or any of its subsidiaries for purposes of the Securities Act.

4.13Sarbanes-Oxley Act.  There is and has been no failure on the part of the Company, any of its subsidiaries and any of its or their directors or officers, in their capacities as such, to comply with any applicable provision of the Sarbanes-Oxley Act of 2002 and the rules and regulations promulgated in connection therewith, including, without limitation, Section 402 relating to loans.

4.14Intellectual Property.  The Company and its subsidiaries own or possess, or have valid licenses to,  or can acquire on reasonable terms, all patents, patent applications, trade and service marks, trade and service mark registrations, trade names, copyrights, licenses, inventions, trade secrets, technology, know-how and other intellectual property (collectively, the “Intellectual Property”) necessary for the conduct of the Company’s and its subsidiaries’ business as now conducted or as proposed in the SEC Documents to be conducted (the “Company Intellectual Property”). The conduct of the Company’s business as currently conducted or as proposed in the SEC Documents to be conducted does not infringe or violate the Intellectual Property rights of any third party, except for any such infringement or violation that will not have a Material Adverse Effect. Neither the Company nor any of its subsidiaries has received any notice of any infringement, misappropriation or other violation of, or conflict with any Intellectual Property rights of any third party. The Company is not aware of any facts or circumstances which would form a reasonable basis to render invalid or unenforceable any issued patents, or any facts or circumstances, apart from such facts or circumstances raised during prosecution, which would form a reasonable basis to render unpatentable or unenforceable any pending patent applications material to the Company’s business as currently conducted or as proposed in the SEC Documents, in each case, owned by or exclusively licensed to the Company or any of its subsidiaries. There is no pending or, to the Company’s knowledge, threatened Action or claim by others challenging the Company’s or any of its subsidiaries rights in or to any Company Intellectual Property. The Company and its subsidiaries have taken commercially reasonable steps to obtain and maintain in force all third party licenses and other permissions in relation to Company Intellectual Property as may be necessary to conduct their respective businesses. 

4.15Compliance with Nasdaq Continued Listing Requirements.  The Company is in compliance with applicable Nasdaq Stock Market, LLC continued listing requirements. There are no proceedings pending or, to the Company’s knowledge, threatened against the Company relating to the continued listing of the Common Stock on The Nasdaq Global Select Market and the Company has not received any notice of, nor to the Company’s knowledge is there any reasonable basis for, the delisting of the Common Stock from The Nasdaq Global Select Market.

4.16Disclosure.  The Company understands that the Purchaser will rely on the foregoing representations in effecting the purchase of the Shares.  The Transaction Documents and the SEC Documents, when taken together with the Schedule of Exceptions and the due 

6

 

 

 

 

 

 

diligence materials regarding the Company furnished by or on behalf of the Company to the Purchasers, are true and correct in all material respects and do not contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in light of the circumstances under which they were made, not misleading.  

4.17Contracts.  Each franchise, contract or other document of a character required to be described in the SEC Documents or to be filed as an exhibit to the SEC Documents under the Securities Act and the rules and regulations promulgated thereunder (collectively, the “Material Contracts”) is so described or filed.  The Company is in compliance with and not in default of its obligations under the Material Contracts, except for such non-compliance or default that will not have a Material Adverse Effect. 

4.18Properties and Assets.  The Company and its subsidiaries own or lease all such properties as are necessary to the conduct of its and their operations as presently conducted. Such assets which are owned by the Company are held free and clear of any security interest, mortgage, pledge, lien, encumbrance, claim or equity, except as described in Section 4.18 of the Schedule of Exceptions.

4.19Compliance.  Except as would not, individually or in the aggregate, result in a Material Adverse Effect or as disclosed in the SEC Documents: (i) each of the Company and each of its subsidiaries is and has been in compliance with statutes, laws, ordinances, rules and regulations applicable to the Company or its subsidiaries for the ownership, testing, development, manufacture, packaging, processing, use, labeling, storage, or disposal of any product manufactured by or on behalf of the Company and its subsidiaries or out-licensed by the Company and its subsidiaries (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (ii) the Company and its subsidiaries possess all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of their properties or the conduct of their business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and neither the Company nor any of its subsidiaries is in violation of any term of any such Authorizations; (iii) neither the Company nor any of its subsidiaries has received any written notice of adverse finding, warning letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other governmental entity alleging or asserting noncompliance with any Applicable Laws or Authorizations relating to a Company Product; (iv) neither the Company nor any of its subsidiaries has received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental entity or third party alleging that any Company Product, operation or activity related to a Company Product is in violation of any Applicable Laws or Authorizations; and (v) neither the Company nor any of its subsidiaries has received written notice that any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations. 

4.20Taxes.  Except as disclosed in Section 4.20 of the Schedule of Exceptions or the SEC Documents, (i) the Company and its subsidiaries have filed all tax returns that are required 

7

 

 

 

 

 

 

to have been be filed by each of them or has requested extensions of the filing date thereof  and (ii) the Company and its subsidiaries have paid all taxes required to be paid by any of them and any other assessment, fine or penalty levied against any of them, to the extent that any of the foregoing is due and payable, except in the case of clause (i) and (ii), for any such assessment, fine or penalty that is currently being contested in good faith or as would not have a Material Adverse Effect, whether or not arising from transactions in the ordinary course of business and (iii) there are no tax audits ongoing of which the Company has received written notice. 

4.21Transfer Taxes.  There are no transfer taxes or other similar fees or charges under Federal law or the laws of any state, or any political subdivision thereof, required to be paid in connection with the execution and delivery of this Agreement or the issuance by the Company or sale by the Company of the Shares. 

4.22Investment Company.  The Company is not and, after giving effect to the offering and sale of the Shares, will not be an “investment company” as defined in the Investment Company Act of 1940, as amended.

4.23Insurance.  The Company and its subsidiaries are insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as are reasonable and customary in the business in which it is engaged; all policies of insurance and fidelity or surety bonds insuring the Company and its subsidiaries or their businesses, assets, employees, officers and directors are in full force and effect; the Company and its subsidiaries are in compliance with the terms of such policies and instruments in all material respects; and there are no claims by the Company or any of its subsidiaries under any such policy or instrument as to which any insurance company is denying liability or defending under a reservation of rights clause; neither the Company nor any of its subsidiaries has been refused any insurance coverage sought or applied for; and the Company has no reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business at a cost that would not have a Material Adverse Effect, whether or not arising from transactions in the ordinary course of business.  

4.24Price of Common Stock.  Neither the Company nor any of its subsidiaries has taken, directly or indirectly, any action designed to cause or result in, or that has constituted or that might reasonably be expected to constitute the stabilization or manipulation of the price of any securities of the Company to facilitate the sale or resale of the Shares. 

4.25Governmental Permits, Etc.  The Company and its subsidiaries possess all licenses, certificates, permits and other authorizations issued by all applicable authorities necessary to conduct its business, and neither the Company nor any of its subsidiaries has received any notice of proceedings relating to the revocation or modification of any such certificate, authorization or permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would have a Material Adverse Effect, whether or not arising from transactions in the ordinary course of business.

4.26Internal Control over Financial Reporting; Sarbanes-Oxley Matters.  The Company maintains a system of internal accounting controls sufficient to provide reasonable 

8

 

 

 

 

 

 

assurance that (i) transactions are executed in accordance with management’s general or specific authorizations; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting principles and to maintain asset accountability; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. The Company’s internal controls over financial reporting are effective to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and the Company is not aware of any material weakness in its internal controls over financial reporting.  The Company maintains “disclosure controls and procedures” (as such term is defined in Rule 13a-15(e) under the Exchange Act); such disclosure controls and procedures are effective as of September 30, 2018.

4.27Foreign Corrupt Practices/Money Laundering Laws.  None of the Company, its subsidiaries or, to the knowledge of the Company, any director, officer, agent, or employee of the Company or any of its subsidiaries has taken any action, directly or indirectly, that is in violation by such persons of the Foreign Corrupt Practices Act of 1977, as amended, and the rules and regulations thereunder (the “FCPA”), including, without limitation, making use of the mails or any means or instrumentality of interstate commerce corruptly in furtherance of an offer, payment, promise to pay or authorization of the payment of any money, or other property, gift, promise to give, or authorization of the giving of anything of value to any “foreign official” (as such term is defined in the FCPA) or any foreign political party or official thereof or any candidate for foreign political office, in contravention of the FCPA. The operations of the Company and its subsidiaries have been conducted in compliance with all applicable money laundering laws and the rules and regulations thereunder.   

4.28Labor.  Neither the Company nor any subsidiary of the Company is bound by or subject to any collective bargaining agreement or any similar agreement with any organization representing its employees. No labor problem or dispute with the employees of the Company and its subsidiaries exists or, to the knowledge of the Company, is threatened, and the Company is not aware of any existing or imminent labor disturbance by the employees of any of its principal suppliers or contractors, that could have a Material Adverse Effect, whether or not arising from transactions in the ordinary course of business, except as contemplated in the SEC Documents.

4.29ERISA.  None of the following events has occurred or exists: (i) a failure to fulfill the obligations, if any, under the minimum funding standards of Section 302 of the United States Employee Retirement Income Security Act of 1974, as amended (“ERISA”), and the regulations and published interpretations thereunder with respect to a Plan that is required to be funded, determined without regard to any waiver of such obligations or extension of any amortization period; (ii) an audit or investigation by the Internal Revenue Service, the U.S. Department of Labor, the Pension Benefit Guaranty Corporation or any other federal or state governmental agency or any foreign regulatory agency with respect to the employment or compensation of employees by any of the Company or any of its subsidiaries that could have a Material Adverse Effect; (iii) any breach of any contractual obligation, or any violation of law or applicable qualification standards, with respect to the employment or compensation of employees by the Company or any of its subsidiaries that would reasonably be expected to have a Material Adverse 

9

 

 

 

 

 

 

Effect. None of the following events has occurred or is reasonably likely to occur: (i) a material increase in the aggregate amount of contributions required to be made to all Plans in the current fiscal year of the Company compared to the amount of such contributions made in the most recently completed fiscal year of the Company; (ii) a material increase in the “accumulated post-retirement benefit obligations” (within the meaning of Statement of Financial Accounting Standards 106) of the Company compared to the amount of such obligations in the most recently completed fiscal year of the Company; (iii) any event or condition giving rise to a liability under Title IV of ERISA that could have a Material Adverse Effect; or (iv) the filing of a claim by one or more employees or former employees of the Company or any of its subsidiaries related to their employment that could have a Material Adverse Effect. For purposes of this paragraph, the term “Plan” means a plan (within the meaning of Section 3(3) of ERISA) subject to Title IV of ERISA with respect to which the Company or any of its subsidiaries may have any liability.

4.30Environmental Laws.  The Company and each of its subsidiaries (i) is in compliance with any and all applicable foreign, federal, state and local laws and regulations relating to the protection of human health and safety, the environment or hazardous or toxic substances or wastes, pollutants or contaminants (“Environmental Laws”), (ii) has received and is in compliance with all permits, licenses or other approvals required of them under applicable Environmental Laws to conduct its business and (iii) has not received notice of any actual or potential liability under any environmental law, except where such non-compliance with Environmental Laws, failure to receive required permits, licenses or other approvals, or liability would not, individually or in the aggregate, have a Material Adverse Effect, whether or not arising from transactions in the ordinary course of business. The Company has not been named as a “potentially responsible party” under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended.

4.31Related Party Transactions. No director or Affiliate of the Company, nor any family member of any officer, director or Affiliate of the Company has entered into any transaction with the Company or any of its subsidiaries that would be required to be disclosed under Item 404 of Regulation S-K that has not been disclosed in the SEC Documents as required by the rules and regulations of the Commission. 

4.32Certain Fees. Except as disclosed in Section 4.32 of the Schedule of Exceptions, no brokerage or finder’s fee or commissions are payable by the Company to any broker, financial advisor, consultant, finder placement agent, investment banker or other person or entity with respect to the transactions contemplated hereby.

SECTION 5.REPRESENTATIONS, WARRANTIES AND COVENANTS OF THE PURCHASER.

5.1Representations and Warranties. The Purchaser represents and warrants to and covenants with the Company that:

(a)The Purchaser is a validly existing corporation, limited partnership or limited liability company and has all requisite corporate, partnership or limited liability company power and authority to enter into and consummate the transactions contemplated by the 

10

 

 

 

 

 

 

Transaction Documents and to carry out its obligations hereunder and thereunder, and to purchase the Shares pursuant to this Agreement.

(b)The Purchaser acknowledges that it can bear the economic risk and complete loss of its investment in the Shares and has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of the investment contemplated hereby. The Purchaser has had an opportunity to receive, review and understand all information related to the Company requested by it and to ask questions of and receive answers from the Company regarding the Company, its business and the terms and conditions of the offering of the Shares, and has conducted and completed its own independent due diligence. The Purchaser acknowledges that the Company has made available the SEC Documents. Based on the information the Purchaser has deemed appropriate, and without reliance upon any third-party, it has independently made its own analysis and decision to enter into the Transaction Documents. The Purchaser is relying exclusively on its own investment analysis and due diligence (including professional advice it deems appropriate) with respect to the execution, delivery and performance of the Transaction Documents, the Shares and the business, condition (financial and otherwise), management, operations, properties and prospects of the Company, including but not limited to all business, legal, regulatory, accounting, credit and tax matters, and has received no representations with regard to the Company or its  business, condition (financial and otherwise), management, operations, properties and prospects, except for those set forth in the Transaction Documents.

(c)The Shares will be acquired for the Purchaser’s own account, not as nominee or agent, and not with a view to the resale or distribution of any part thereof in violation of the Securities Act, and the Purchaser has no present intention of selling, granting any participation in, or otherwise distributing the same in violation of the Securities Act without prejudice, however, to the Purchaser’s right at all times to sell or otherwise dispose of all or any part of such Shares in compliance with applicable federal and state securities laws. The Purchaser is not a broker-dealer registered with the SEC under the Exchange Act or an entity engaged in a business that would require it to be so registered. The Purchaser understands that the Shares are characterized as “restricted securities” under the U.S. federal securities laws inasmuch as they are being acquired from the Company in a transaction not involving a public offering and that under such laws and applicable regulations such securities may be resold without registration under the Securities Act only in certain limited circumstances. Purchaser will not, directly or indirectly, offer, sell, pledge, transfer or otherwise dispose of (or solicit any offers to buy, purchase or otherwise acquire or take a pledge of) any of the securities purchased hereunder except in compliance with the Standstill Agreement, Securities Act, applicable blue sky laws, and the rules and regulations promulgated thereunder. The Purchaser has no present intent to effect a “change of control” of the Company as such term is understood under the rules promulgated pursuant to Section 13(d) of the Exchange Act. 

(d)The Purchaser is an “accredited investor” within the meaning of Rule 501(a) under the Securities Act. The Purchaser has determined based on its own independent review and such professional advice as it deems appropriate that its purchase of the Shares and participation in the transactions contemplated by the Transaction Documents (i) are fully consistent with its financial needs, objectives and condition, (ii) comply and are fully consistent with all investment policies, guidelines and other restrictions applicable to the Purchaser, (iii) 

11

 

 

 

 

 

 

have been duly authorized and approved by all necessary action, (iv) do not and will not violate or constitute a default under the Purchaser’s charter, by-laws or other constituent document or under any law, rule, regulation, agreement or other obligation by which the Purchaser is bound and (v) are a fit, proper and suitable investment for the Purchaser, notwithstanding the substantial risks inherent in investing in or holding the Shares.

(e)The execution, delivery and performance by the Purchaser of the Transaction Documents to which the Purchaser is a party have been duly authorized and each has been duly executed and delivered and constitute the valid and legally binding obligation of the Purchaser, enforceable against the Purchaser in accordance with their respective terms, subject to the Enforceability Limitations. 

(f)The execution, delivery and performance by the Purchaser of the Transaction Documents and the consummation by the Purchaser of the transactions contemplated hereby and thereby will not (i) result in a violation of the organizational documents of the Purchaser, (ii) conflict with, or constitute a default (or an event which with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, any agreement, indenture or instrument to which the Purchaser is a party, or (iii) result in a violation of any law, rule, regulation, order, judgment or decree (including federal and state securities laws) applicable to the Purchaser, except in the case of clauses (ii) and (iii) above, for such conflicts, defaults, rights or violations which would not, individually or in the aggregate, reasonably be expected to have a material adverse effect on the ability of the Purchaser to perform its obligations under the Transaction Documents.

(g)No third-party will have, as a result of the transactions contemplated by this Agreement, any valid right, interest or claim against or upon the Company or any Purchaser for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of the Purchaser.  Purchaser is not a broker or dealer registered pursuant to Section 15 of the Exchange Act (a “registered broker-dealer”) and is not affiliated with a registered broker dealer.  Purchaser is not party to any agreement for distribution of any of the Shares.

(h)Purchaser shall have completed or caused to be completed and delivered to the Company no later than the Closing Date, the Purchaser Questionnaire, and the answers to the Purchaser Questionnaire are true and correct in all material respects as of the date of this Agreement and will be true and correct as of the Closing Date and the effective date of the any registration statement; provided that the Purchasers shall be entitled to update such information by providing notice thereof to the Company before the effective date of such registration statement.

(i)To the extent the Purchaser provides a written request to the Company to file a registration statement pursuant to the Registration Rights Agreement, the Purchaser shall have completed or caused to be completed and delivered to the Company concurrently with such written request to the Company, the Selling Stockholder Questionnaire, and the answers to the Selling Stockholder Questionnaire are true and correct as of the date of such written request and the effective date of the registration statement; provided that the Purchasers shall be entitled to 

12

 

 

 

 

 

 

update such information by providing notice thereof to the Company before the effective date of such registration statement.

(j)The Purchaser understands that no United States federal or state agency, or similar agency of any other country, has reviewed, approved, passed upon, or made any recommendation or endorsement of the Company or the purchase of the Shares. 

(k)The Purchaser has not taken any of the actions set forth in, and is not subject to, the disqualification provisions of Rule 506(d)(1) of the Securities Act.

(l)The Purchaser did not learn of the investment in the Shares as a result of any general solicitation or general advertising.

(m)Other than pursuant to this Agreement and the [8,489,584] shares of Common Stock held by Purchaser, neither the Purchaser nor any of its Affiliates currently owns any interest in or has contracted to purchase any shares of Common Stock or any securities convertible into or exerciseable or exchangeable for shares of Common Stock.

(n)The Purchaser is aware that the anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of Common Stock and other activities with respect to the Shares purchased by the Purchaser.

5.2Short Sales.  Other than consummating the transactions contemplated hereunder, the Purchaser has not, nor has any person acting on behalf of or pursuant to any understanding with the Purchaser, directly or indirectly executed any purchases or sales, including all “short sales” as defined in Rule 200 of Regulation SHO under the Exchange Act (but shall not be deemed to include the location and/or reservation of borrowable shares of Common Stock) (“Short Sales”), of the securities of the Company during the period commencing as of the time that the Purchaser first contacted by the Company or any other person regarding the transactions contemplated hereby and ending immediately prior to the Effective Date. The Purchaser has maintained the confidentiality of all disclosures made to it in connection with this transaction (including the existence and terms of this transaction).   

5.3Tax Advice.  Purchaser understands that nothing in this Agreement or any other materials presented to Purchaser in connection with the purchase and sale of the Shares constitutes legal, tax or investment advice. Purchaser has consulted such legal, tax and investment advisors as it, in its sole discretion, has deemed necessary or appropriate in connection with its purchase of the Shares.

5.4Transfer Restrictions.  

(a)Compliance with Laws.  Notwithstanding any other provision of this Agreement, the Purchaser covenants that the Shares may be disposed of only pursuant to (x) an effective registration statement under, and in compliance with the requirements of, the Securities Act, or pursuant to an available exemption from, or in a transaction not subject to, the registration requirements of the Securities Act, and in compliance with any applicable state and federal securities laws and (y) in accordance with the terms of the Standstill Agreement (for so long as the restrictions set forth therein shall remain in effect). In connection with any transfer of 

13

 

 

 

 

 

 

the Shares other than (i) pursuant to an effective registration statement, (ii) to the Company, (iii) to an Affiliate (as defined below) of the Purchaser or (iv) pursuant to Rule 144 (provided that the Purchaser provides the Company with reasonable assurances (in the form of seller and broker representation letters) that the securities may be sold pursuant to such rule) or Rule 144A, the Company may require the transferor thereof to provide to the Company an opinion of counsel selected by the transferor and reasonably acceptable to the Company, the form and substance of which opinion shall be reasonably satisfactory to the Company, to the effect that such transfer does not require registration of such transferred Securities under the Securities Act.  During the term of the Standstill Agreement, the Purchaser may not, without the consent of the Company, transfer the Shares to any person or entity, other than an Affiliate of the Purchaser.  As a condition of transfer of any Shares to any such Affiliate, any such Affiliate (i) shall agree in writing to be bound by the terms of this Agreement and shall have the rights of the Purchaser under this Agreement and the Registration Rights Agreement, and (ii) for so long as the restrictions set forth the Standstill Agreement shall remain in effect, shall agree in writing to be bound by the applicable terms of the Standstill Agreement (unless otherwise agreed in writing by the Company).  For the purposes hereof, “Affiliate” means, with respect to any Person, any other Person that, directly or indirectly through one or more intermediaries, Controls, is controlled by or is under common control with such Person, as such terms are used in and construed under Rule 144.  With respect to a Purchaser that is an entity, any investment fund or managed account that is managed on a discretionary basis by the same investment manager as such Purchaser will be deemed to be an Affiliate of such Purchaser. For purposes hereof, “Control” (including the terms “controlling,” “controlled by” or “under common control with”) means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, by contract or otherwise.

(b)Legends.  Each of the book entry notations evidencing the Shares shall bear any legend as required by the “blue sky” laws of any state and the restrictive legends in substantially the following form, as applicable, until such time as they are not required under Section 5.4(c) (and a stock transfer order may be placed against transfer of the certificates for the Shares): 

THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR APPLICABLE STATE SECURITIES LAWS.  THE SECURITIES MAY NOT BE OFFERED FOR SALE, SOLD, TRANSFERRED OR ASSIGNED EXCEPT AS PROVIDED BY ARTICLE IV OF THAT CERTAIN SECURITIES PURCHASE AGREEMENT, DATED AS OF NOVEMBER 3, 2016, BETWEEN AIMMUNE THERAPEUTICS, INC. AND NESTLE HEALTH SCIENCE US HOLDINGS, INC.

THESE SECURITIES ARE SUBJECT TO RESTRICTIONS ON TRANSFERABILITY AND RESALE AND CERTAIN OTHER RESTRICTIONS, ALL AS SET FORTH IN A Standstill Agreement BETWEEN AIMMUNE THERAPEUTICS, INC. AND NESTLE HEALTH SCIENCE US HOLDINGS, INC. ENTERED INTO PURSUANT TO THAT CERTAIN SECURITIES PURCHASE AGREEMENT, DATED AS OF 

14

 

 

 

 

 

 

NOVEMBER 3, 2016, BETWEEN AIMMUNE THERAPEUTICS, INC. AND NESTLE HEALTH SCIENCE US HOLDINGS, INC.

 

(c)Removal of Legends. The legends set forth in Section 5.4(b) above shall be removed and the Company shall issue a certificate without such legends or any other legend to the holder of the applicable Shares upon which it is stamped or issue to such holder by electronic delivery at the applicable balance account at the Depository Trust Company (“DTC”), if (A) such Shares have been or may be transferred in accordance with the terms of the Standstill Agreement without restriction; and (B) (i) such Shares are sold or transferred pursuant to an effective registration statement covering the resale of such Shares by the Purchaser, (ii) such Shares are sold or transferred pursuant to Rule 144 (if the transferor is not an Affiliate of the Company), or (iii) such Shares are eligible for sale without any restrictions under Rule 144 (any Securities meeting such criteria being referred to as “Unrestricted Securities”). Following such time as a legend is no longer required for certain Shares, the Company will no later than three (3) business days (or such shorter time as may in the future be required pursuant to applicable law or regulation for the settlement of trades in securities on The Nasdaq Global Select Market) following the delivery by the Purchaser to the Company or the Company’s transfer agent of a certificate representing Shares and if such Shares are certificated, issued with a restrictive legend, together with such representations and covenants of the Purchaser or the Purchaser’s executing broker as the Company may reasonably require in connection therewith, deliver or cause to be delivered to the Purchaser a book entry position representing such shares that is free from any legend referring to the Securities Act. The Company may not make any notation on its records or give instructions to the Transfer Agent that enlarge the restrictions on transfer set forth in this Section 5.4.  In lieu of delivering physical certificates, upon the written request of any Purchaser, the Company shall use its commercially reasonable efforts to transmit certificates for Shares subject to full legend removal hereunder to such Purchaser by crediting the account of the transferee’s Purchaser’s prime broker with DTC through its Deposit Withdrawal Agent Commission (“DWAC”) system, or any successor system thereto.  The time periods for delivery shall apply to the electronic transmittals described herein.  Any delivery not effected by electronic transmission shall be effected by delivery of physical certificates.  The Purchaser agrees that the removal of (x) the restrictive legend referring to the Standstill Agreement from any certificates representing Shares as set forth in this Section 5.4(c) is predicated upon either (A) a transfer of such Shares in strict compliance with the terms of the Standstill Agreement or (B) the termination of the restrictions set forth in the Standstill Agreement; and (y) the restrictive legend referring to the Securities Act from any certificates representing Shares as set forth in this Section 5.4(c) above is predicated upon the Company’s reliance that such Purchaser would sell, transfer, assign, pledge, hypothecate or otherwise dispose of such Shares pursuant to either the registration requirements of the Securities Act, including any applicable prospectus delivery requirements, or an exemption therefrom, and that if such Securities are sold pursuant to a registration statement, they will be sold in compliance with the plan of distribution set forth therein.  

(d)Acknowledgment.  Purchaser hereunder acknowledges its primary responsibilities under the Securities Act and, accordingly, will not sell or otherwise transfer any of the Shares or any interest therein without complying with the requirements of the Securities Act.  While any registration statement remains effective, Purchaser hereunder may, subject to the 

15

 

 

 

 

 

 

provisions of the Standstill Agreement, sell the Shares in accordance with the plan of distribution contained in such registration statement and, if it does so, it will comply therewith and with the related prospectus delivery requirements unless an exemption therefrom is available. The Purchaser agrees that if it is notified by the Company in writing at any time that a registration statement registering the resale of any of the Shares is not effective or that the prospectus included in such registration statement no longer complies with the requirements of Section 10 of the Securities Act, the Purchaser will refrain from selling such Shares until such time as the Purchaser is notified by the Company that such registration statement is effective or such prospectus is compliant with Section 10 of the Exchange Act, unless such Purchaser is able to, and does, sell such Shares pursuant to an available exemption from the registration requirements of Section 5 of the Securities Act. 

SECTION 6.CONDITIONS TO COMPANY’S OBLIGATIONS AT THE CLOSING.

The Company’s obligation to complete the sale and issuance of the Shares and deliver Shares to the Purchaser at the Closing shall be subject to the following conditions to the extent not waived by the Company:

6.1Receipt of Payment.  The Company shall have received payment of the Aggregate Purchase Price, by wire transfer of immediately available funds to such account as the Company shall be designated in writing to the Purchaser not less than two (2) business days prior to the Closing Date.

6.2Representations and Warranties.  The representations and warranties made by the Purchaser in Section 5 hereof shall be true and correct in all material respects when made, and shall be true and correct in all material respects on the Closing Date with the same force and effect as if they had been made on and as of said date. The Purchaser shall have performed in all material respects all obligations and covenants herein required to be performed by it on or prior to the Closing Date. 

6.3Receipt of Executed Documents.  The Purchaser shall have executed and delivered to the Company the Registration Rights Agreement, the Collaboration Agreement, the Standstill Agreement and the Purchaser Questionnaire as of the Effective Date.

6.4HSR Act. All applicable waiting periods, if any, in respect of the transactions contemplated hereby and by the Transaction Documents under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and its implementing regulations (the “HSR Act”) will have expired or terminated.

SECTION 7.CONDITIONS TO PURCHASER’S OBLIGATIONS AT THE CLOSING.

The Purchaser’s obligation to accept delivery of the Shares and to pay the Aggregate Purchase Price for the Shares shall be subject to the following conditions to the extent not waived by the Purchaser:

7.1Representations and Warranties Correct.  The representations and warranties made by the Company in Section 4 hereof shall be true and correct in all material respects as of, and as if made on, the date of this Agreement and as of the Closing Date, except to the extent any 

16

 

 

 

 

 

 

such representation or warranty expressly speaks as of an earlier date, in which case such representation or warranty shall be true and correct as of such earlier date. The Company shall have performed in all material respects all obligations and covenants herein required to be performed by it on or prior to the Closing Date.  

7.2Receipt of Executed Registration Rights Agreement and Standstill Agreement.  The Company shall have executed and delivered to the Purchaser the Registration Rights Agreement and the Standstill Agreement as of the Effective Date.

7.3Receipt of Executed Collaboration Agreement.  The Company shall have executed and delivered to the Purchaser the Collaboration Agreement as of the Effective Date.

7.4Legal Opinion.  The Purchaser shall have received an opinion of Latham & Watkins LLP, special counsel to the Company, dated as of the Closing Date, in form and substance reasonably acceptable to the Purchaser.

7.5Certificate.  The Purchaser shall have received a certificate signed by the Chief Executive Officer or the Chief Financial Officer to the effect that the representations and warranties of the Company in Section 4 hereof are true and correct in all material respects as of, and as if made on, the date of this Agreement and as of the Closing Date and that the Company has satisfied all of the conditions set forth in this Section 7.

7.6Good Standing.  The Company shall have delivered to the Purchaser a good standing certificate for the Company, issued by the Secretary of State of the State of Delaware, dated not less than five (5) business days prior to the Closing Date.  

7.7Nasdaq Approval.  The Company shall have filed with The Nasdaq Global Select Market a Notification Form: Listing of Additional Shares for the listing of the Shares, and furnished to the Purchaser evidence of the filing thereof.

7.8Judgments.  No judgment, writ, order, injunction, award or decree of or by any court, or judge, justice or magistrate, including any bankruptcy court or judge, or any order of or by any governmental authority, shall have been issued, and no action or proceeding shall have been instituted by any governmental authority, enjoining or preventing the consummation of the transactions contemplated hereby.

7.9Stop Orders.  No stop order or suspension of trading shall have been imposed by The Nasdaq Global Select Market, the Commission  or any other governmental regulatory body with respect to public trading in the Common Stock.

7.10Board Approval. The Company shall have delivered to the Purchaser resolutions of the Board certified by the Company’s Secretary, approving (i) the transactions contemplated by the Transaction Documents (ii) the Purchaser continuing as an “interested stockholder” as defined in Section 203 of the Delaware General Corporation Law and, (iii) subject to the Standstill Agreement, such additional purchase(s) of Common Stock by the Purchaser during the three year period following the Closing, or through the date that is six (6) months following the termination of the Collaboration Agreement, if later, which result in NHSc owning up to 15.12% of the Company’s outstanding Common Stock.

17

 

 

 

 

 

 

7.11HSR Act. All applicable waiting periods, if any, in respect of the transactions contemplated hereby and by the Transaction Documents under the HSR Act will have expired or terminated.

SECTION 8.Termination of Obligations to Effect Closing; Effects.

8.1Termination. The obligations of the Company, on the one hand, and the Purchaser, on the other hand, to effect the Closing shall terminate as follows: 

(a)upon the mutual written consent of the Company and the Purchaser; 

(b)by the Company if by December 31, 2018, any of the conditions set forth in Section 6 shall have not been satisfied, and shall not have been waived by the Company; or 

(c)by the Purchaser if by December 31, 2018, any of the conditions set forth in Section 7 shall have not been satisfied, and shall not have been waived by the Purchaser; 

provided, however, that, in the case of clauses (b) and (c) above, the party seeking to terminate its obligation to effect the Closing shall not then be in breach of any of its representations, warranties, covenants or agreements contained in this Agreement or the other Transaction Documents if such breach has resulted in the circumstances giving rise to such party’s seeking to terminate its obligation to effect the Closing. 

8.2Effect of Termination. Upon termination in accordance with Section 8.1, except as otherwise contemplated by this Agreement, this Agreement shall forthwith become null and void and there shall thereafter be no liability under this Agreement of the part of either party; provided however, that nothing in this Section 8 shall be deemed to release any party from any liability for any breach by such party of the terms and provisions of this Agreement or to impair the right of any party to compel specific performance by any other party of its obligations under this Agreement. 

SECTION 9.RESERVED.

SECTION 10.Additional Agreements of the Parties.

10.1Nasdaq Listing. The Company will use commercially reasonable efforts to continue the listing and trading of its Common Stock on The Nasdaq Global Select Market and, in accordance, therewith, will use commercially reasonable efforts to comply in all respects with the Company’s reporting, filing and other obligations under the bylaws or rules of such market or exchange, as applicable.

10.2Access to Information. From the date hereof until the Closing, the Company will make reasonably available to the Purchaser’s representatives, consultants and counsel for inspection, such information and documents as the Purchaser reasonably request, and will make available at reasonable times and to a reasonable extent officers and employees of the Company to discuss the business and affairs of the Company.

18

 

 

 

 

 

 

10.3Termination of Covenants.  The provisions of Section 10.1 and 10.2 shall terminate and be of no further force and effect on the date on which the Company’s obligations under the Registration Rights Agreement to register or maintain the effectiveness of any registration covering the Registrable Securities (as such term is defined in the Registration Rights Agreement) shall terminate.

10.4Use of Proceeds. The Company agrees that until the second anniversary of the Closing date, the proceeds from the sale and issuance of the Shares to the Purchaser shall be used to fund the costs and expenses of clinical trials and for general working capital and will not be used for purposes of any cash dividend or cash distribution to any stockholder of the Company (other than in respect of repurchases or redemptions of capital stock pursuant to contractual arrangements as in effect on the date hereof for such repurchases or redemptions).  

10.5Form D; Blue Sky Filings. The Company agrees to timely file a Form D with respect to the Shares and to provide a copy thereof, promptly upon request of the Purchaser. The Company shall take such action as the Company shall reasonably determine is necessary in order to obtain an exemption for, or to qualify the Shares for, sale to the Purchaser at the Closing under applicable securities or “Blue Sky” laws of the states of the United States, and shall provide evidence of such actions promptly upon request of the Purchaser.

10.6Integration. The Company shall not, and shall use its commercially reasonable efforts to ensure that no affiliate of the Company shall, sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in Section 2 of the Securities Act) that will be integrated with the offer or sale of the Shares in a manner that would require the registration under the Securities Act of the sale of the Shares to the Purchaser, or that will be integrated with the offer or sale of the Shares for purposes of the rules and regulations of any trading market such that it would require stockholder approval prior to the closing of such other transaction unless stockholder approval is obtained before the closing of such subsequent transaction.

10.7Short Sales and Confidentiality After the Date Hereof. The Purchaser covenants that neither it nor any Affiliates acting on its behalf or pursuant to any understanding with it will execute any Short Sales during the period from the date hereof until the earlier of such time as (i) after the transactions contemplated by this Agreement are first publicly announced or (ii) this Agreement is terminated in full. The Purchaser covenants that until such time as the transactions contemplated by this Agreement are publicly disclosed by the Company in accordance with Section 10.8, the Purchaser will maintain the confidentiality of all disclosures made to it in connection with this transaction (including the existence and terms of this transaction). The Purchaser understands and acknowledges that the Commission currently takes the position that coverage of short sales of shares of the Common Stock “against the box” prior to effectiveness of a resale registration statement with securities included in such registration statement would be a violation of Section 5 of the Securities Act, as set forth in Item 239.10 of the Securities Act Rules Compliance and Disclosure Interpretations compiled by the Office of Chief Counsel, Division of Corporation Finance. 

10.8Securities Laws Disclosure; Publicity. By 5:00 P.M., New York City time, on the trading day immediately following the Effective Date, the Company shall issue a press release 

19

 

 

 

 

 

 

disclosing the material terms of the transactions contemplated hereby.  On or before 9:00 A.M., New York City time, on the third trading day immediately following the execution of this Agreement, the Company will file a Current Report on Form 8-K (the “8-K”) with the Commission describing the terms of the Transaction Documents.  

10.9Regulatory Approvals; Efforts of the Parties. Subject to the terms and conditions of this Agreement, each of the Company and the Purchaser agree to use commercially reasonable efforts to take, or cause to be taken, all necessary actions, and to do, or cause to be done, all things necessary under applicable law to consummate the transactions contemplated by this Agreement.  Without limitation to the generality of the foregoing, each of the Purchaser and the Company agree to make all appropriate filings that may be required under the HSR Act as promptly as practicable following the Effective Date, but in any event within ten (10) calendar days of the Effective Date.  Nothing in this Section 10.9 shall require, or be deemed to require, the Company or the Purchaser (a) to propose, negotiate, offer to, commit to or effect any sale, divestiture, or disposition of assets or businesses, or licenses or (b) to agree to hold separate any assets or agree to any similar arrangements or to commit to restrict the dominion or control of its business or to conduct its business in a specified manner, in each case, in order to secure any government approval required in connection with the transactions contemplated hereby.

10.10Further Assurances. Each of the parties shall execute such further documents and perform such further acts (including, without limitation, obtaining any consents, exemptions, authorizations or other actions by, or giving notices to, or making any filings with, any governmental entity, if necessary) as may be reasonably requested by the other party to fully implement the intent and purpose of this Agreement. 

SECTION 11.Indemnification.

11.1Indemnification by the Company.  The Company agrees to indemnify and hold harmless the Purchaser and each Person (defined below), if any, who controls or is under common control with the Purchaser within the meaning of the Securities Act (each, an “Indemnified Party”), against any losses, claims, damages, liabilities or expenses, joint or several, to which such Indemnified Party may become subject under the Securities Act, the Exchange Act, or any other federal or state statutory law or regulation, or at common law (including in settlement of any litigation, if such settlement is effected with the written consent of the Company), insofar as such losses, claims, damages, liabilities or expenses (or actions in respect thereof as contemplated below) arise out of or are based in whole or in part on any inaccuracy in the representations and warranties of the Company contained in this Agreement or any failure of the Company to perform its obligations hereunder, and will reimburse each Indemnified Party for legal and other expenses reasonably incurred as such expenses are reasonably incurred by such Indemnified Party in connection with investigating, defending, settling, compromising or paying such loss, claim, damage, liability, expense or action.  For purposes of clarity, the Company will not be liable to any Indemnified Party to the extent that any loss, claim, damage, liability or expense arises out of or is based upon (i) the failure of such Indemnified Party to comply with the covenants and agreements contained in this Agreement, or (ii) the inaccuracy of any representations made by such Indemnified Party herein. The term “Person” means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, 

20

 

 

 

 

 

 

limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.

11.2Indemnification by the Purchaser.  The Purchaser shall indemnify and hold harmless the Company, each of its directors, and each Person, if any, who controls or is under common control with the Company within the meaning of the Securities Act (the “Company Indemnified Parties”), against any losses, claims, damages, liabilities or expenses to which the Company, each of its directors or each of its controlling Persons may become subject, under the Securities Act, the Exchange Act, or any other federal or state statutory law or regulation, or at common law or otherwise (including in settlement of any litigation, if such settlement is effected with the written consent of the Purchaser) insofar as such losses, claims, damages, liabilities or expenses (or actions in respect thereof as contemplated below) arise out of or are based in whole or in part on any inaccuracy in the representations and warranties of the Purchaser contained in this Agreement or any failure of the Purchaser to perform its obligations hereunder , and will reimburse the applicable Company Indemnified Parties for any legal and other expense reasonably incurred, as such expenses are reasonably incurred by any Company Indemnified Parties in connection with investigating, defending, settling, compromising or paying any such loss, claim, damage, liability, expense or action. For purposes of clarity, the Purchaser will not be liable to any Company Indemnified Party to the extent that any loss, claim, damage, liability or expense arises out of or is based upon (i) the failure of a Company Indemnified Party to comply with the covenants and agreements contained in this Agreement, or (ii) the inaccuracy of any representations made by a Company Indemnified Party herein.  

SECTION 12.NOTICES.

All notices, requests, consents and other communications hereunder shall be in writing, shall be sent by confirmed facsimile or electronic mail, or mailed by first-class registered or certified airmail, or nationally recognized overnight express courier, postage prepaid, and shall be deemed given when so sent in the case of facsimile or electronic mail transmission, or when so received in the case of mail or courier, and addressed as follows:

(a)if to the Company, to:

Aimmune Therapeutics, Inc.

8000 Marine Blvd., Suite 300

Brisbane, California, 94005

Attention: Chief Executive Officer

Facsimile: (650) 616-0075

E-Mail:  ****

 

	

	
with a copy (which shall not constitute notice) to:

Latham & Watkins LLP 

140 Scott Drive

Menlo Park, California  94025

Attention:  Patrick A. Pohlen and Brian J. Cuneo
Facsimile:  (650) 463-2600

E-Mail:  ****

	
 
	

	
  ****

21

 

 

 

 

 

 

 

or to such other person at such other place as the Company shall designate to the Purchaser in writing; and

(b)if to the Purchaser, to:

Nestle Health Science US Holdings, Inc.

900 Long Ridge Road, Building 2

Stamford, CT 06902

Attention: Andrew Glass

F: (480) 379-5510

 

E-Mail:  ****

 

	

	
with a copy (which shall not constitute notice) to:

 

Nestlé Health Science S.A.

Avenue Nestlé, 55

1800 Vevey

Switzerland

Attention: General Counsel

Facsimile: 011-41-21-924-2875

 

 

	

	
with a further copy (which shall not constitute notice) to:

 

Mayer Brown LLP

	
 
	
1221 Avenue of the Americas
New York, NY 10020
Attention: 
	
David A. Carpenter

Facsimile: (212) 849-5795

	
 
	
E-Mail:  ****
	

 

or to such other address or addresses as may have been furnished to the Company in writing.

SECTION 13.MISCELLANEOUS.

13.1Waivers and Amendments.  Neither this Agreement nor any provision hereof may be changed, waived, discharged, terminated, modified or amended except upon the written consent of the Company and the Purchaser.

13.2Headings.  The headings of the various sections of this Agreement have been inserted for convenience of reference only and shall not be deemed to be part of this Agreement.

22

 

 

 

 

 

 

13.3Severability.  In case any provision contained in this Agreement should be invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby.

13.4Replacement of Shares.  If the Shares are certificated and any certificate or instrument evidencing any Shares is mutilated, lost, stolen or destroyed, the Company shall issue or cause to be issued in exchange and substitution for and upon cancellation thereof, or in lieu of and substitution therefor, a new certificate or instrument, but only upon receipt of evidence reasonably satisfactory to the Company and the Company’s transfer agent of such loss, theft or destruction and the execution by the holder thereof of a customary lost certificate affidavit of that fact and an agreement to indemnify and hold harmless the Company and the Company’s transfer agent for any losses in connection therewith or, if required by the transfer agent, a bond in such form and amount as is required by the transfer agent.  The applicants for a new certificate or instrument under such circumstances shall also pay any reasonable third-party costs associated with the issuance of such replacement Shares.  If a replacement certificate or instrument evidencing any Shares is requested due to a mutilation thereof, the Company may require delivery of such mutilated certificate or instrument as a condition precedent to any issuance of a replacement.

13.5Specific Performance.  The parties hereto agree that irreparable damages would occur if any provision of this Agreement were not performed in accordance with the terms hereof and that the parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement or to enforce specifically the performance of the terms hereof, in addition to any other remedy to which the party may be entitled under applicable law. 

13.6Governing Law.  All questions concerning the construction, validity, enforcement and interpretation of this Agreement shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflicts of law thereof.  Each party agrees that all legal proceedings concerning the interpretations, enforcement and defense of the transactions contemplated by this Agreement (whether brought against a party hereto or its respective affiliates, directors, officers, shareholders, employees or agents) shall be commenced exclusively in the state and federal courts sitting in the City and County of New York. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the City and County of New York for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein (including with respect to the enforcement of any of this Agreement), and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is improper or is an inconvenient venue for such proceeding.  Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Agreement and agrees that such service shall constitute good and sufficient service of process and notice thereof.  Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law.

23

 

 

 

 

 

 

13.7Counterparts.  This Agreement may be executed and delivered (including by facsimile or portable document format (“pdf”) in two or more counterparts, each of which shall constitute an original, but all of which, when taken together, shall constitute but one instrument, and shall become effective when one or more counterparts have been signed by each party hereto and delivered to the other parties.

13.8Successors and Assigns.  Without the prior written consent of the Company, the rights and obligations of the Purchaser under this Agreement may only be assigned to a transferee of the Shares that is an Affiliate of the Purchaser and only upon compliance with the transfer restrictions set out in Section 5.4 hereof.  Without the consent of the Purchaser, the Company may not assign its rights and obligations under this Agreement. The provisions hereof shall inure to the benefit of, and be binding upon, the successors and permitted assigns of the parties hereto.

13.9Entire Agreement.  This Agreement and other documents delivered pursuant hereto, including the exhibit and the Schedule of Exceptions, constitute the full and entire understanding and agreement between the parties with regard to the subjects hereof and thereof.

13.10Payment of Fees and Expenses.  Each of the Company and the Purchaser shall bear its own expenses and legal fees incurred on its behalf with respect to this Agreement and the transactions contemplated hereby.  If any action at law or in equity is necessary to enforce or interpret the terms of this Agreement, the prevailing party shall be entitled to reasonable attorney’s fees, costs and necessary disbursements in addition to any other relief to which such party may be entitled.

13.11Survival.  The representations, warranties, covenants and agreements made in this Agreement shall survive any investigation made by the Company or the Purchaser and the Closing.

[signature pages follow]

 

24

 

 

 

 

 

 

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly authorized representatives as of the day and year first above written.

AIMMUNE THERAPEUTICS, INC.

 

 

By:  /s/ Jayson Dallas

Name:  Jayson Dallas M.D.

Title:  President and Chief Executive Officer

 

SIGNATURE PAGES TO

SECURITIES PURCHASE AGREEMENT

 

Nestle Health Science US Holdings, Inc.

 

		
	
 
	

	
  
	
  By:     /s/ James Pepin

	
 
	
  Name:  James Pepin

	
 
	
  Title:    President

	
 
	
 

	
 
	
 

	
 
	
 

 

SIGNATURE PAGES TO

SECURITIES PURCHASE AGREEMENT

 

 

 

 

APPENDIX I

Purchaser Questionnaire

 

 

APPENDIX II

Selling Stockholder Questionnaire

 

 

APPENDIX III

Registration Rights Agreement

 

 

 

 

APPENDIX IV

Collaboration Agreement

 

 

 

 

 

APPENDIX V

Standstill Agreement

 

 

 

SCHEDULE OF EXCEPTIONS

 

This Schedule of Exceptions is being furnished by Aimmune Therapeutics, Inc., a Delaware corporation (the “Company”), to Nestle Health Science US Holdings, Inc., a Delaware corporation (the “Purchaser”), pursuant to that certain Securities Purchase Agreement of even date herewith between the Company and the Purchaser (the “Agreement”) in connection with the execution and delivery of the Agreement, pursuant to Section 4 of the Agreement.  Unless the context otherwise requires, all capitalized terms used in this Schedule of Exceptions shall have the respective meanings ascribed to such terms in the Agreement.

 

This Schedule of Exceptions and the information, descriptions and disclosures included herein is intended to set forth exceptions to the representations and warranties of the Company contained in the Agreement.  The contents of all agreements and other documents referred to in a particular section of this Schedule of Exceptions are incorporated by reference into such particular section as though fully set forth in such section.  

 

4.2 Subsidiaries

 

Aimmune Therapeutics (Bermuda), Ltd.

Aimmune Therapeutics UK Limited

Aimmune Netherlands B.V.

AIMT Netherlands Cooperatief U.A.

 

4.18 Properties and Assets

 

None.

 

4.20 Taxes

 

None.

 

4.31Related Party Transactions

 

In June 2017, Mark McDade, a member of our Board of Directors, joined the Board of Directors of MyHealthTeams, a private company that creates social networks for people living with chronic conditions by partnering with pharmaceutical and healthcare companies. We entered into an agreement with MyHealthTeams in 2015 under which they provide services to us. During the years ended December 31, 2017, 2016 and 2015, our payments to MyHealthTeams pursuant to such agreement were $0.2 million, $0.2 million and less than $0.1 million, respectively. At December 31, 2017 and 2016, there were no accrued liabilities due under the MyHealthTeams agreement.

 

4.32 Certain Fees

 

None.aimt-ex105_774.htm

Confidential Treatment Requested by Aimmune Therapeutics, Inc.

Exhibit 10.5(a)

 

AMENDED AND RESTATED

STRATEGIC COLLABORATION AGREEMENT

between

NESTEC LTD.

and

AIMMUNE THERAPEUTICS, INC.

 

 

 

1

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	
ARTICLE 1
	
DEFINITIONS1
	
 

	
 
	
1.1
	
Definitions1
	
 

	
ARTICLE 2
	
OBJECTIVES; COLLABORATION6
	
 

	
 
	
2.1
	
Objectives6
	
 

	
 
	
2.2
	
Scope of Collaboration6
	
 

	
 
	
2.3
	
Formation and Composition of the Strategic Collaboration Committee6
	
 

	
 
	
2.4
	
Role of Strategic Collaboration Committee7
	
 

	
 
	
2.5
	
Information Sharing7
	
 

	
 
	
2.6
	
Opportunities7
	
 

	
 
	
2.7
	
Meetings of SCC8
	
 

	
ARTICLE 3
	
LICENSE OPPORTUNITIES8
	
 

	
 
	
3.1
	
Proposal by NHSc to Explore Combination Therapy8
	
 

	
ARTICLE 4
	
REPRESENTATIONS AND WARRANTIES9
	
 

	
 
	
4.1
	
Organization9
	
 

	
 
	
4.2
	
Authorization9
	
 

	
 
	
4.3
	
Binding Agreement9
	
 

	
 
	
4.4
	
No Conflict10
	
 

	
 
	
4.5
	
No Consents10
	
 

	
ARTICLE 5
	
INTELLECTUAL PROPERTY10
	
 

	
 
	
5.1
	
Ownership of Intellectual Property10
	
 

	
 
	
5.2
	
New Opportunities Proposed by NHSc10
	
 

	
 
	
5.3
	
No License; Implied Rights10
	
 

	
ARTICLE 6
	
CONFIDENTIAL INFORMATION11
	
 

	
 
	
6.1
	
Nondisclosure11
	
 

	
 
	
6.2
	
Authorized Disclosure11
	
 

	
 
	
6.3
	
Terms of this Agreement12
	
 

	
 
	
6.4
	
Securities Filings12
	
 

	
 
	
6.5
	
Expiration or Termination12
	
 

	
ARTICLE 7
	
ADDITIONAL AGREEMENTS13
	
 

	
 
	
7.1
	
Non-Competition13
	
 

	
 
	
7.2
	
Non-Solicitation of Employees14
	
 

	
 
	
7.3
	
Director Nomination14
	
 

	
ARTICLE 8
	
TERM AND TERMINATION15
	
 

	
 
	
8.1
	
Effectiveness; Term15
	
 

	
 
	
8.2
	
Termination Rights15
	
 

	
 
	
8.3
	
Effect of Termination15
	
 

i

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	
ARTICLE 9
	
MISCELLANEOUS16
	
 

	
 
	
9.1
	
Expenses16
	
 

	
 
	
9.2
	
Severability16
	
 

	
 
	
9.3
	
Notices16
	
 

	
 
	
9.4
	
Assignment17
	
 

	
 
	
9.5
	
Further Assurances17
	
 

	
 
	
9.6
	
Waivers and Modifications17
	
 

	
 
	
9.7
	
Choice of Law18
	
 

	
 
	
9.8
	
Injunctive Relief18
	
 

	
 
	
9.9
	
Publicity18
	
 

	
 
	
9.10
	
Relationship of the Parties18
	
 

	
 
	
9.11
	
Entire Agreement18
	
 

	
 
	
9.12
	
Counterparts19
	
 

	
 
	
9.13
	
Exports19
	
 

	
 
	
9.14
	
Amendments19
	
 

	
 
	
9.15
	
Interpretation19
	
 

 

Exhibits

 

Exhibit A-Development Programs

 

 

ii

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

AMENDED AND RESTATED STRATEGIC COLLABORATION AGREEMENT

	

	
This AMENDED AND RESTATED STRATEGIC COLLABORATION AGREEMENT (this “Agreement”) is made as of November 11, 2018 (the “Effective Date”), by and between NESTEC LTD., a limited company organized and existing under the laws of Switzerland, having an office located at Avenue Nestlé 55, 1800 Vevey, Switzerland (“NHSc”), and Aimmune Therapeutics, Inc., a corporation incorporated and existing under the laws of the State of Delaware, having an office located at 8000 Marina Boulevard, Suite 300, Brisbane, CA 94005, USA (“Aimmune”).  NHSc and Aimmune are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

RECITALS

	

	
WHEREAS, Aimmune is engaged in the development of immunotherapeutic products for the treatment of food allergies; 

	

	
WHEREAS, NHSc and certain of its Affiliates are engaged in the research, development and commercialization of food products for the management of food allergies and has expertise in regulatory and market access matters relevant to such products;

	

	
WHEREAS, the Parties entered into that certain Strategic Collaboration Agreement (the “Original Agreement”), effective as of November 3, 2016 (the “Original Effective Date”), under which the Parties began a collaboration in connection with the development of Aimmune’s products; and

	

	
WHEREAS, the Parties wish to amend and restate the Original Agreement with effect from the Effective Date of this Agreement.

	

	
NOW, THEREFORE in consideration of the foregoing and the mutual agreements set forth below, the Parties agree as follows:

Article 1
DEFINITIONS

Definitions

. The terms in this Agreement with initial letters capitalized, whether used in the singular or the plural, shall have the respective meanings either set forth below or another part of this Agreement.

“Acceptance Notice” has the meaning set forth in Section 2.6.1.

“Affiliate” of a Party means an entity that (directly or indirectly) is controlled by, controls, or is under common control with such Party where control means the direct or indirect ownership of voting securities entitled to cast at least fifty percent (50%) of the votes in the election of directors, or such other relationship as results in the power to control the management, business, assets and affairs of an entity.

2

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

“Aimmune Product” means a drug or biologic product for use as OIT for the treatment of food allergies that is being researched or developed by Aimmune or its Affiliates from time to time during the Term.

“Aimmune-Owned Inventions and IP” has the meaning set forth in Section 5.1.

“AR101” means Aimmune’s proprietary OIT product for the treatment of peanut allergy known as AR101.

“BLA” means a Biologics License Application, as defined in the United States Public Health Service Act (42 U.S.C. § 262), and applicable regulations promulgated thereunder by the FDA.

“Business Day” means a day other than Saturday, Sunday or any day on which commercial banks located in San Francisco, California or Geneva, Switzerland, are authorized or obligated by applicable Law to close.

“Calendar Quarter” means, with respect to any given Calendar Year, the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31.

“Change of Control” means, with respect to a Party, any of the following events: (a) any Third Party (or group of Third Parties acting in concert) acquires, directly or indirectly, shares of such Party representing at least a majority of the voting power (where voting refers to being entitled to vote for the election of directors) then outstanding of such Party; (b) such Party consolidates with or merges into another corporation or entity which is a Third Party, or any corporation or entity which is a Third Party consolidates with or merges into such Party, in either event pursuant to a transaction in which at least a majority of the voting power of the acquiring or resulting entity outstanding immediately after such consolidation or merger is not held by the holders of the outstanding voting power of such Party immediately preceding such consolidation or merger; or (c) such Party sells, conveys, transfers and/or exclusively licenses all or substantially all of its assets to a Third Party.

“Closing” has the meaning set forth in the Purchase Agreement.

“Combination Discussion Period” has the meaning set forth in Section 3.1.

“Combination Proposal Period” has the meaning set forth in Section 3.1.

“Competitive OIT Product” has the meaning set forth in Section 7.1.1.

“Confidential Information” means any and all technical, business or other Information, of a Party or its Affiliates provided orally, visually, in writing, graphically, electronically, or in another form by or on behalf of such Party or its Affiliates to the other Party or its Affiliates in connection with this Agreement, including the terms of this Agreement, any Aimmune Product, any exploitation of any Aimmune Product, any know-how with respect thereto developed by or on behalf of the disclosing Party or its Affiliates, or the scientific, regulatory or business affairs or other activities of the disclosing Party or its Affiliates.  

3

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

“Controlled” or “Control”, when used in reference to any intellectual property, intellectual property right, material, know-how or information, means the legal authority or right of a Party hereto (or its Affiliates) to: (i) grant, or procure the grant of, a license or sublicense, to the extent provided for herein, under or to specified intellectual property, intellectual property rights, materials, know-how or information to the other Party; or (ii) in relation to materials, know-how and information only, disclose or provide access to, to the extent provided for herein, such material, know-how or information to the other Party, and in each case without (1) breaching the terms of any agreement with a Third Party, or (2) misappropriating the material, know-how or information of a Third Party.  

“Development” means non-clinical and clinical drug development activities reasonably related to the development and submission of information to a Regulatory Authority or otherwise to the research, identification, testing and validation of a therapeutic agent, including, without limitation, toxicology, pharmacology and other discovery and pre-clinical efforts, test method development and stability testing, manufacturing process and chemistry, manufacturing and controls development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, clinical trials (including, without limitation, pre- and post-approval studies), whether for purposes of label expansion or otherwise.  Development shall include post-approval Development activities.  When used as a verb, “Develop” means to engage in Development.

“Development Program” means Aimmune’s and/or its Affiliates’ activities directed towards the Development of a specific Aimmune Product for the treatment of allergies to one (1) or more particular types of food, including [***] and [***].  The Development Programs as of the date of this Agreement are described on Exhibit A hereto.

“Disclosing Party” has the meaning set forth in Section 6.1.

“Effective Date” means the effective date of this Agreement as set forth in the preamble hereto.

“European Union” means, at any given time, the then-current member states of the European Union.

“FD&C Act” means the United States Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

“Governmental Authority” means any multi-national, federal, state, local, municipal, provincial or other governmental authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).

“In-Scope Programs” has the meaning set forth in Section 2.2. 

4

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

“IND” means an Investigational New Drug Application (as such term is defined in the FD&C Act and the regulations promulgated thereunder), Clinical Trial Authorisation (as such term is defined in the Directive 2001/20/EC, as amended), clinical trial exemption, or similar application or submission for approval to conduct human clinical investigations that is filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.

“Information” means all technical, scientific and other know-how and information, inventions, discoveries, trade secrets, knowledge, technology, means, methods, processes, formulations, practices, formulae, instructions, skills, techniques, procedures, experiences, expressed ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results, materials (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical), pre-clinical, clinical, safety, manufacturing and quality control data and information (including study designs and protocols) and assays and biological methodology, in each case, whether or not confidential, proprietary or patentable and in written, oral, electronic or any other form now known or hereafter developed.

“Laws” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision.

“Major Territory” means any of (i) [***], (ii) [***], (iii) [***], and (iv) [***].

“NDA” means a New Drug Application, as defined in the FD&C Act.

“New Opportunities” has the meaning set forth in Section 2.6.

“OIT” means a therapy involving the oral delivery of quantities of a naturally-occurring allergen, whether obtained from a natural source or generated by synthetic means, to a patient in order to desensitize the patient to such allergen.

“OIT Allergy Company” has the meaning set forth in Section 7.1.2.

“OIT Combination” has the meaning set forth in Section 3.1.

“OIT Combination Opportunity” has the meaning set forth in Section 3.1.

“OIT Combination Constituent” means any drug or biologic product (i.e., any product which, if it were marketed in the United States, must be approved by the FDA pursuant to a BLA or NDA), such as but not limited to a probiotic or other microbiome-based product, that can be combined with an OIT product and that is intended to improve the efficacy or safety of such OIT product for the treatment of one (1) or more food allergies.

“Pass Notice” has the meaning set forth in Section 2.6.1.

“Patents” means (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all patent applications filed either from such patents 

5

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

or patent applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, nonprovisionals, converted provisionals and requests for continued examinations, (c) any and all patents that have issued or in the future issue from the foregoing patent applications (i.e., those set forth in subsections (a) and (b)), including utility models, innovation patents, petty patents and design patents and certificates of invention, (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, and all revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications (i.e., those set forth in subsections (a), (b) and (c)) and (e) any similar rights, including so-called pipeline protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents.

“Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, foundation, joint venture or other similar entity, organization or combination thereof, including a government or political subdivision, department, or agency.

“Prohibited Development” has the meaning set forth in Section 7.1.1.

“Prohibited Drug Research” has the meaning set forth in Section 7.1.1.

“Purchase Agreement” means the Securities Purchase Agreement, dated the date hereof,  by and between Aimmune and Nestlé  Health Science US Holdings, Inc.

“Receiving Party” has the meaning set forth in Section 6.1.

“Single Product Asset Sale” means the sale, transfer, or license to a Third Party by Aimmune of a single Aimmune Product or Development Program that could reasonably be considered to constitute the sale, transfer or exclusive license of all or substantially all of Aimmune’s assets such that the transaction would be considered a Change of Control under clause (c) of the definition. 

“Strategic Collaboration Committee” or “SCC” has the meaning set forth in Section 2.3.

“Term” has the meaning set forth in Section 8.1.

“Third Party” means any entity other than NHSc, Aimmune and their respective Affiliates.

“Transfer” means the sale, transfer, or license to a Third Party by Aimmune, or grant to a Third Party by Aimmune of any option to acquire or license, any commercial rights to an Aimmune Product or Development Program; provided, however, for purposes of clarity, other than a Single Product Asset Sale, a Change of Control shall not constitute or be deemed to constitute a Transfer.  “Transfers,” “Transferred” and “Transferring” have correlative meanings.

“United States” or “U.S.”  means the United States of America, including its territories and possessions.

6

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Article 2
OBJECTIVES; COLLABORATION

Objectives

. This Agreement sets forth the terms on which the Parties will collaborate with one another and share information on a confidential basis to support Aimmune’s Development Programs to the extent they are In-Scope Programs.  Such collaboration and information sharing shall be achieved primarily through the Strategic Collaboration Committee, in accordance with this Article 2.

Scope of Collaboration

.  This Agreement and the collaboration contemplated hereby shall relate to all of Aimmune’s Development Programs, including those existing as of the Original Effective Date and those undertaken from time-to-time during the Term, and commercialization plans for AR101; provided, however, that (i) in the event that Aimmune effects a Transfer in respect of an Aimmune Product under Development pursuant to a particular Development Program in all Major Territories, such Development Program shall automatically be excluded from the scope of this Agreement and the collaboration contemplated hereunder, (ii) in the event that Aimmune effects a Transfer in respect of an Aimmune Product under Development pursuant to a particular Development Program in one (1) or more, but not all, Major Territories, then the scope of this Agreement and the collaboration contemplated hereunder shall automatically be adjusted to exclude such Development Program solely in respect of such Major Territory(ies) in respect of which Aimmune has effected such Transfer in respect of such Aimmune Product, and (iii) in the event Aimmune effects a Transfer in respect of the commercialization of AR101 in one (1) or more countries, then the scope of this Agreement and the collaboration contemplated hereunder shall automatically be adjusted to exclude the country(ies) in respect of which Aimmune has effected such Transfer in respect of such Aimmune Product.   Aimmune shall disclose to NHSc each new Development Program upon Aimmune’s decision to commence such Development Program and such new Development Program shall automatically be included within the scope of this Agreement and the collaboration contemplated hereby.  All Development Programs or parts thereof, as well as commercialization plans for AR101 that are conducted during the Term, in each case that are within the scope of this Agreement at a particular time during the Term, in accordance with this Section 2.2, are referred to herein as the “In-Scope Programs”.  For clarity, In-Scope Programs shall not include any products or programs of any counterparty in a Change of Control of Aimmune that were not Aimmune Products or Development Programs immediately preceding the closing of the relevant Change of Control.

Formation and Composition of the Strategic Collaboration Committee

.  The governing body for matters within the scope of this Agreement shall be the “Strategic Collaboration Committee” or “SCC”.  The SCC shall be comprised of three (3) to five (5) representatives of each Party.  The initial members of the SCC shall be:

7

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

		
		
	
From Aimmune
	
From NHSc

	
[***]
[***]
[***]
[***]

[***] 
	
[***]
[***]
[***]
[***]

 

Either Party may replace one (1) or more of its SCC members from time to time with the prior written consent of the other Party, not to be unreasonably withheld, delayed or conditioned.  Any member of the SCC may designate a substitute to attend and perform the functions of that member at any meeting of the SCC, provided that the other Party has provided its prior written consent to such substitute, not to be unreasonably withheld, delayed or conditioned.   For clarity, during the Term, the Parties shall consider whether to include alternative members of the SCC having expertise in areas relevant to the collaboration contemplated hereby at such time.

Role of Strategic Collaboration Committee

.  The SCC shall serve as a forum for the Parties, through their SCC members, to share information and discuss the In-Scope Programs, including with respect to commercialization plans for AR101.  The SCC shall have no decision-making role and neither the SCC nor the SCC members shall have the capacity to bind either Party in any way.  Any advice provided by NHSc’s SCC members shall be non-binding in all respects. 

Information Sharing

.  At each meeting of the SCC, Aimmune’s representatives shall provide (i) an update on material Development activities in respect of In-Scope Programs, including with respect to material results or data from in vitro and in vivo testing, regulatory developments and strategies, manufacturing activities and commercial plans, and (ii) an overview of Aimmune’s future plans in respect of the In-Scope Programs.  All such information provided by Aimmune shall be Confidential Information of Aimmune, including with respect to commercialization plans for AR101, provided that in no event shall Aimmune be required to share any information that is subject to any confidentiality obligations to Third Parties with respect to the In-Scope Programs.  NHSc’s representatives may, but shall not be obligated to, disclose non-public information of NHSc or its Affiliates to Aimmune’s SCC members as further described in Section 2.6.  All such information disclosed by NHSc shall be Confidential Information of NHSc. 

Opportunities

.  Through the SCC, either Party may, but would not be obligated to, share opportunities (excluding Development Programs, which Aimmune is obligated to disclose pursuant to Section 2.2) to apply innovative technologies for use in, or in conjunction with, OIT for the treatment of food allergies or food intolerance (“New Opportunities”), as set forth in Sections 2.6.1 and 2.6.2.    

2.6.1If either Party wishes to share a New Opportunity with the other Party, it shall first provide to the other Party a written, high level description of the nature of the New Opportunity, to allow the other Party to determine whether it wishes to engage in a detailed discussion of such New Opportunity pursuant to this Agreement.  A copy of such description shall be provided concurrently to the other Party's general counsel as provided in Section 9.3.  The Party receiving such high level description shall respond in writing within fifteen (15) days, or such longer period as the Parties may agree to in writing, whether it wishes to engage in a detailed discussion of such New Opportunity (an “Acceptance Notice”) or whether it declines to engage 

8

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

in such a detailed discussion (a “Pass Notice”).  If either the receiving Party provides a Pass Notice, or the receiving Party does not respond in writing to such high level description of such New Opportunity within such period, then the Party wishing to share such New Opportunity shall not provide any further information to the receiving Party with respect to such New Opportunity.  If the receiving Party delivers an Acceptance Notice, then the Parties, through the SCC, shall be free to discuss the New Opportunity, subject to the terms of Article 5 and Article 6, or subject to such alternative or modified terms relating to intellectual property and/or Confidential Information as the Parties may have agreed to in writing prior to the receiving Party’s delivery of such Acceptance Notice.

2.6.2For the sake of clarity, Information disclosed by a Party in respect of any New Opportunity shall be Confidential Information of such Party (subject to the exceptions set forth in Section 6.1.1).  Neither Party shall obtain any intellectual property or other rights in any Information so disclosed by the other Party with respect to such New Opportunity or in respect of such New Opportunity, unless and until the Parties enter into a separate written agreement in respect thereof.

Meetings of SCC

.  The SCC will meet at least once per Calendar Quarter, or more frequently, if agreed by the SCC.  The location of regularly scheduled meetings shall alternate between the offices of the Parties unless otherwise agreed by the SCC.  Meetings of the SCC may also be held telephonically, by video conference or by any other media agreed to by the SCC.  Members of the SCC shall have the right to participate in meetings by telephone.  Each Party shall be responsible for expenses incurred by its employees and its members of the SCC in attending or otherwise participating in SCC meetings, including travel and related costs.  Either Party may invite additional representatives of the Party who have relevant expertise to attend SCC meetings when appropriate for the issues being addressed at the meeting with five (5) Business Days’ prior notice to the other Party’s SCC representatives, provided that any such additional representatives shall be bound by obligations of confidentiality at least as stringent as those set forth in Section 6 and obligations with respect to Information arising in the course of activities under this Agreement consistent with those set forth in Section 5, and further provided that any such additional representatives shall be subject to the other Party's prior written approval.

Article 3
LICENSE OPPORTUNITIES

Proposal by NHSc to Explore Combination Therapy

.  If (i) NHSc or its Affiliate possesses any commercial rights (whether by ownership, license or an option or similar right) to an OIT Combination Constituent, and (ii) NHSc’s or its Affiliate’s senior management has affirmatively determined to pursue Development (including research) of a combination of such OIT Combination Constituent with an OIT drug or biologic (an “OIT Combination”), then NHSc shall so notify Aimmune in writing. Such notice shall identify the OIT Combination Constituent that NHSc is contemplating for an OIT Combination, and the general nature of the activities that NHSc proposes to conduct, with respect to such OIT Combination, including the applicable geographies (collectively, in each case, the “OIT Combination Opportunity”).  Within [***] ([***]) days of its receipt of such notice (the “Combination Proposal Period”), Aimmune shall have the right, in its sole discretion, to notify NHSc in writing that it wishes to negotiate an agreement with NHSc in respect of such OIT Combination Opportunity.  In the event Aimmune 

9

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

so makes such an election during the Combination Proposal Period, the Parties shall negotiate exclusively and in good faith for a period of three (3) months or such longer period as the Parties may mutually agree upon (as applicable, the “Combination Discussion Period”) the terms of a definitive agreement in respect of such OIT Combination Opportunity.  During the Combination Proposal Period and, if applicable, the Combination Discussion Period, NHSc shall not solicit from, discuss with, or enter into any agreement in respect of, any OIT Combination Opportunity with any Third Party. If the Parties have not entered into a definitive agreement governing the OIT Combination Opportunity as of the end of the Combination Discussion Period, NHSc shall be free to partner or collaborate with a Third Party with respect to such OIT Combination Opportunity, including to modify the scope or other terms of the OIT Combination Opportunity in connection with any such transaction with a Third Party.  To the extent that the Term of this Agreement expires (and is not terminated pursuant to Section 9.2), this Section 3.1 shall survive and continue in accordance with its terms until the end of any then-ongoing Combination Proposal Period or any then-ongoing Combination Discussion Period, and any Combination Discussion Period resulting from such Combination Proposal Period.  The Parties agree and acknowledge that the OIT Combination Constituent that is the subject of any OIT Combination Opportunity may be part of a licensing, collaboration or other transaction between NHSc or is Affiliate and one (1) or more Third Parties and that such Third Parties may be involved in any such discussions contemplated in this Section 3.1.

Article 4
REPRESENTATIONS AND WARRANTIES

Aimmune and NHSc each represents and warrants to the other, as of the Original Effective Date, as follows:

Organization

.  It is 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.

Authorization

.  The execution and delivery of this Agreement and the performance by it of its obligations contemplated hereby have been duly authorized by all necessary corporate action, and do not violate (i) such Party’s charter documents, bylaws, or other organizational documents, (ii) any agreement, instrument, or contractual obligation to which such Party is bound, (iii) any requirement of any applicable Law, or (iv) any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to such Party.

Binding Agreement

.  This Agreement is a legal, valid, and binding obligation of such Party enforceable against it in accordance with its terms and conditions, 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).

No Conflict

.  The execution and delivery of this Agreement, the performance of such Party’s obligations hereunder and the licenses and sublicenses to be granted pursuant to this Agreement (i) do not and will not conflict with or violate any requirement of applicable Law; (ii) do not and will not conflict with or violate the certificate of incorporation, by-laws or other 

10

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

organizational documents of such Party; and (iii) do not and will not conflict with, violate, breach or constitute a default under any contractual obligations of such Party or any of its Affiliates.

No Consents

.  No authorization, consent, approval of a Third Party, nor any license, permit, exemption of or filing or registration with or notification to any court or Governmental Authority is or will be necessary (i) for the valid execution, delivery or performance of this Agreement by such Party; or (ii) for the consummation by such Party of the transactions contemplated hereby.

Article 5
INTELLECTUAL PROPERTY

Ownership of Intellectual Property

.  As between the Parties, except as may otherwise be agreed by the Parties in writing, Aimmune shall solely own all right, title, and interest in and to any and all Information relating to, or that is useful or necessary for, the conduct of the Development Programs, In-Scope Programs or the manufacture, use or sale of Aimmune Products, that is conceived, discovered, or otherwise made (a) solely by or on behalf of Aimmune, (b) jointly by or on behalf of Aimmune and NHSc, or (c) solely by or on behalf of NHSc, in each case of subsections (a) through (c), as a result of NHSc’s participation in the SCC or with reference to Aimmune’s Confidential Information, whether or not patented or patentable, and any and all Patents and other intellectual property rights therein (“Aimmune-Owned Inventions and IP”).  NHSc shall, and hereby does, assign to Aimmune all right, title and interest that NHSc may have in and to all Aimmune-Owned Inventions and IP, and shall execute all documents and take all actions necessary or reasonably required to effect such assignment.  For the sake of clarity, except as may otherwise be agreed by the Parties in writing, any Information, and any Patents or other intellectual property rights in respect thereof, that are (i) Controlled, discovered or conceived by NHSc or its Affiliates prior to the Original Effective Date, or (ii) conceived, discovered or obtained by NHSc or its Affiliates during or after the Term and independent of the collaboration pursuant to this Agreement shall be solely owned by NHSc or its Affiliate.  

5.2New Opportunities Proposed by NHSc.  Section 5.1 notwithstanding, if NHSc discloses or presents a New Opportunity to the SCC, and the SCC proceeds to discuss such New Opportunity as contemplated in Section 2.6, then if any Information is conceived, discovered or otherwise made solely by or on behalf of a Party, or jointly by or on behalf of the Parties, in the course of such discussion that relates to such New Opportunity, such Information shall be owned solely by NHSc or its Affiliate. 

No License; Implied Rights

.  Neither Party shall obtain any license or other rights to any Information or intellectual property rights therein by virtue of this Agreement.  Without limiting the foregoing, nothing contained in this Agreement confers or will be construed to confer any rights or licenses by implication, estoppel or otherwise, in, to or under any intellectual property rights.

11

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Article 6
CONFIDENTIAL INFORMATION

Nondisclosure

.  Each Party agrees that during the Term and for a period of ten (10) years thereafter, a Party (the “Receiving Party”) receiving Confidential Information of the other Party (the “Disclosing Party”) shall (i) maintain in confidence such Confidential Information, which shall include without limitation using not less than the efforts such Receiving Party uses to maintain in confidence its own proprietary industrial information of similar kind and value, which shall be no less than a reasonable degree of care, (ii) not disclose such Confidential Information to any Third Party without the prior written consent of the Disclosing Party, except for disclosures expressly permitted below, and (iii) not use such Confidential Information for any purpose except those expressly permitted by this Agreement. The Parties agree that any Confidential Information (within the meaning of the Prior CDA) disclosed by the Parties or their Affiliates pursuant to the Prior CDA shall be Confidential Information within the meaning of, and shall be subject to, this Article 6.

Exceptions

.  The obligations in Section 6.1 shall not apply with respect to any portion of the Confidential Information that the Receiving Party receives, to the extent that such information:

(a)is publicly disclosed by the Disclosing Party, either before or after it is disclosed to the Receiving Party hereunder; 

(b)was known to the Receiving Party or any of its Affiliates, without any obligation to keep it confidential or any restriction on its use, prior to disclosure by the Disclosing Party, provided that such prior knowledge can be properly documented by the Receiving Party; 

(c)is subsequently disclosed to the Receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof and without any obligation to keep it confidential or any restriction on its use; 

(d)is published by a Third Party or otherwise becomes publicly available or enters the public domain, either before or after it is disclosed to the Receiving Party without the fault or cause of the Receiving Party or any of its Affiliates; or

(e)is independently developed by employees or contractors of the Receiving Party or any of its Affiliates without the aid, application or use of Confidential Information of the Disclosing Party, and such independent development can be properly documented by the Receiving Party.

Authorized Disclosure

.  Subject to Section 6.4, the Receiving Party may disclose Confidential Information belonging to the Disclosing Party to the extent such disclosure is necessary, in the reasonable opinion of the Receiving Party’s counsel, to comply with applicable Laws and regulations (including, without limitation, the rules and regulations of the Securities and Exchange Commission or any national securities exchange) and with judicial processes.  If and whenever any Confidential Information is disclosed in accordance with this Section 6.2, such 

12

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

disclosure shall not cause any such information to cease to be Confidential Information, except to the extent that such disclosure results in a public disclosure of such information (other than by breach of this Agreement).  Where reasonably possible and subject to Section 6.4, the Receiving Party shall:  (i) give the Disclosing Party reasonable advance notice of the Receiving Party’s intent to make such disclosure pursuant to this Section 6.2, to the extent practicable; and  (ii) provide reasonable cooperation to the Disclosing Party regarding the timing and content of such disclosure and regarding any action which the Disclosing Party may deem appropriate to protect the confidentiality of the information by appropriate legal means.

Terms of this Agreement

.  The Parties acknowledge that the terms of this Agreement shall be treated as Confidential Information of both Parties, subject to the terms of this Section 6.  

Securities Filings

.  In the event either Party determines that it is required to file with the U.S. Securities and Exchange Commission (and/or the securities regulators of any state or other jurisdiction) a registration statement or any other disclosure document which describes any of the terms and conditions of this Agreement, such Party shall promptly notify the other Party of such intention.  The Party required to make such filing shall provide such other Party with a copy of relevant portions of the proposed filing not less than ten (10) Business Days (or such shorter period of time as may be required, under the circumstances, to comply with applicable Laws, but in no event less than three (3) Business Days) prior to such filing (and any revisions to such portions of the proposed filing a reasonable time prior to the filing thereof), including any exhibits thereto relating to the terms and conditions of this Agreement.  The Party required to file shall use reasonable efforts to obtain confidential treatment of the terms and conditions of this Agreement that such other Party requests be kept confidential, and shall only disclose Confidential Information which it is advised by legal counsel is legally required to be disclosed in order to comply.  No such notice shall be required under this Section 6.4 if and to the extent that the specific information contained in the proposed filing has previously been included in any previous filing or disclosure made by either Party hereunder pursuant to this Article 6, or is otherwise approved in advance in writing by the other Party. 

Expiration or Termination

.  Upon the expiration or termination of this Agreement, any and all Confidential Information possessed in a tangible form by a Receiving Party, its Affiliates, sublicensees or subcontractors and belonging to a Disclosing Party shall, upon written request of the Disclosing Party, be destroyed to the extent practicable, with written confirmation of such destruction. Notwithstanding anything to the contrary herein, so long as such materials are maintained in accordance with this Agreement, each Party (i) may retain any attorney work product created in connection with this Agreement, (ii) may retain copies of any Confidential Information to the extent required by legal, regulatory or judicial requirements that are applicable to a Party or its Affiliates; and, (iii) will not be obligated to erase or extinguish any Confidential Information contained in an archived computer system backup in accordance with normal document retention policies or security and disaster recovery procedures, provided that any such retained Confidential Information shall continue to remain confidential and subject to the terms of this Agreement.

13

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Article 7
ADDITIONAL AGREEMENTS

Non-Competition

.   

7.1.1NHSc agrees that it will not, and will ensure that its Affiliates do not, directly or indirectly, alone or with or through its Affiliates or its sublicensees, or other Third Parties directed or controlled by NHSc or its Affiliate in relation to the applicable activities, by contract or otherwise: 

(a)until the later of (i) the date that is [***] ([***]) [***] after the Original Effective Date and (ii) the date that is [***] ([***]) [***] after the final day of the Term, engage in Prohibited Drug Research in respect of, or any Prohibited Development of, or commercialize, any Competitive OIT Product for the treatment of peanut allergies; 

(b)until the later of (i) the date that is [***] ([***]) [***] after the Original Effective Date and (ii) the date that is [***] ([***]) [***] after the final day of the Term, engage in any Prohibited Development of, or commercialize, any Competitive OIT Product for the treatment of any allergies to [***], or [***] (including but not limited to [***]); or 

(c)until the later of (i) the date that is [***] ([***]) [***] after the Original Effective Date and (ii) [***] the Term, commercialize any Competitive OIT Product for the treatment of any food allergies [***] of this Section 7.1.1.  As used herein, the following terms have the following meanings:

“Competitive OIT Product” means any drug or biologic product (i.e., any product which, if it were marketed in the United States, must be approved by the FDA pursuant to a BLA or NDA) that is intended for use in OIT for a particular food allergy; provided, however, that no product that comprises such a drug or biological product in combination with any OIT Combination Constituent for which NHSc complies with its obligations under Section 3.1,  shall be a “Competitive OIT Product”. 

“Prohibited Development” means any Development activities undertaken for a given drug or biologic product (i.e., any product which, if it were marketed in the United States, must be approved by the FDA pursuant to a BLA or NDA) for the treatment of the applicable allergy after the commencement of manufacturing of the clinical supply of such drug or biologic products.  For clarity, Prohibited Development shall include without limitation Development activities undertaken after the filing of an IND with a Regulatory Authority in respect of such drug or biologic product.

“Prohibited Drug Research” means research undertaken specifically in respect of, and during the course of, Development activities for a given drug or biologic product (i.e., any product which, if it were marketed in the United States, must be approved by the FDA pursuant to a BLA or NDA) that is intended for use in OIT for the treatment of the applicable allergy, prior to Prohibited Development Activities for such drug or biologic product.

14

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

For the sake of clarity, nothing contained herein shall preclude, limit or restrict in any way NHSc or any of its Affiliates from, directly or indirectly, alone or with or through their Affiliates, sublicensees or other Third Parties, from undertaking any Development, commercialization or any other activities in respect of (i) any product that is not a drug or biologic (i.e., any product which, if it were marketed in the United States, would not require the approval of the FDA pursuant to a BLA or NDA), including medical foods and supplements or (ii) any product for the prevention of food allergies to [***] Developed as part of the development program being pursued as of the Effective Date by NHSc or its Affiliate and the National Institutes of Allergy and Infectious Diseases (NIAID), including any such products that are intended for use by individuals with food allergies.  Aimmune expressly acknowledges that NHSc and its Affiliates are currently researching, Developing and commercializing such products and will continue to do so during and after the Term, directly or indirectly, alone or with or through its Affiliates, sublicensees or other Third Parties. 

7.1.2During the Term, NHSc will [***] (an “OIT Allergy Company”). 

7.1.3Nothing contained herein shall preclude NHSc or its Affiliates from [***].

Non-Solicitation of Employees

.  [***], neither Party shall, and each party shall cause its Affiliates not to, directly or indirectly, solicit, encourage, recruit or induce any employee of the other Party who has been involved in activities or discussions conducted pursuant to this Agreement to terminate his or her employment with such other Party; provided that the foregoing restriction shall not preclude a Party or its Affiliates from (a) undertaking any general solicitation not targeted at the employees of the other Party or hiring an employee of the other Party who seeks employment as a result of such general solicitation or (b) hiring any former employee of the other Party if such former employee either (i) was involuntarily terminated by the other Party, or (ii) voluntarily terminated his or her employment with such other Party (without inducement on the part of the hiring Party or its Affiliates) and such termination of employment has been effective for no less than [***] ([***]) months prior to the date of hire by the hiring Party or its Affiliates.

Director Nomination

. NHSc shall be entitled to designate one (1) nominee to serve as a director on Aimmune’s Board of Directors, which initial designee shall be Greg Behar. For so long as NHSc has the right to nominate a director pursuant to this Section 7.3, in the event of Mr. Behar’s resignation, removal or death (or a replacement designee’s resignation, removal or death), NHSc shall be entitled to designate a replacement designee, subject to the reasonable approval of Aimmune’s Board of Directors or an applicable committee thereof. Aimmune covenants and agrees that, for so long as NHSc has the right set forth in this Section 7.3, it shall nominate NHSc’s designee for election by its stockholders at each Annual Stockholder Meeting or Special Meeting of Stockholders in which the class of directors for which NHSc’s designee is appointed is considered by the stockholders for election. In connection with Mr. Behar’s initial appointment to Aimmune’s Board of Directors (or, if applicable, a replacement designee’s appointment to Aimmune’s Board of Directors), Aimmune shall enter into an indemnification agreement with Mr. Behar (or, if applicable, the replacement designee), which indemnification agreement shall be in the form of and with terms previously approved by Aimmune’s Board of Directors. The rights set forth in this Section 7.3 shall terminate upon  such time as NHSc or its Affiliates hold less than fourteen percent (14%) of the shares of Aimmune’s outstanding Common Stock.  

15

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Article 8
TERM AND TERMINATION

Effectiveness; Term

.  This Agreement shall automatically become binding and effective upon the Original Effective Date and shall continue in force until the earlier of (i) the date that is two (2) years after the Effective Date, (ii) the effective date of a termination in accordance with Section 8.2, and (iii)  the termination of this Agreement by mutual written agreement of the Parties (the “Term”); provided, however, that the Term may be extended upon the mutual written agreement of the Parties.  In the event that the Purchase Agreement is terminated pursuant to Section 8.1(b) or (c) thereof, this Agreement shall automatically terminate.

Termination Rights

. 

8.2.1Termination for Material Breach.  A Party shall have the right to terminate this Agreement in such Party’s sole discretion, upon delivery of written notice to the other Party in the event of any material breach by such other Party of this Agreement, provided that such breach has not been cured within sixty (60) calendar days after written notice thereof is given by the terminating Party specifying the nature of the alleged material breach in reasonable detail.  

8.2.2Change of Control.  Either Party may terminate this Agreement upon written notice to the other Party in the event such other Party undergoes a Change of Control.

8.2.3Third Party Transaction.  In the event that any Development Program, Aimmune Product or Major Territory ceases to be, or be part of, an In-Scope Program by virtue of a Transfer involving one (1) or more of the Aimmune Product(s), as contemplated by Section 2.2, then NHSc may terminate this Agreement upon written notice to Aimmune given within sixty (60) days after NHSc gains knowledge of Aimmune’s entering into an agreement in respect of such Transfer.

8.2.4NHSc Transaction.  Aimmune may terminate this Agreement upon written notice to NHSc during the sixty (60) day period following the closing of an acquisition or combination of the nature contemplated in Section 7.1.3.

Effect of Termination

.  At the end of the Term, this Agreement shall become void and have no effect, provided that (i) the following provisions hereof shall survive any such termination and remain in full force and effect in accordance with the terms thereof: Sections 3.1, 7.1, 7.3 and 8.3 and Articles 5, 6 and 9; (ii) such termination shall not relieve either Party of any obligation, or deprive either Party from any benefit, accruing prior thereto, and (iii) such termination shall be without prejudice to the rights and remedies of any party with respect to any antecedent breach of the provisions of this Agreement. 

Article 9
MISCELLANEOUS

Expenses

.  All fees and expenses incurred in connection with this Agreement and the transactions contemplated hereby shall be paid by the Party incurring such fees and expenses.

16

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Severability

.  If and to the extent that any provision (or any part thereof) of this Agreement is held to be invalid, illegal or unenforceable, in any respect in any jurisdiction, the provision (or the relevant part thereof) shall be considered severed from this Agreement and shall not serve to invalidate the remainder of such provision or any other provisions hereof.  The Parties shall make a good faith effort to replace any invalid, illegal or unenforceable provision (or any part thereof) with a valid, legal and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

Notices

.  Any notice required or permitted to be given by the Parties pursuant to this Agreement shall be in writing and shall be (i) delivered by hand, (ii) delivered by overnight courier with tracking capabilities, (iii) mailed postage prepaid by first class, registered or certified mail, or (iv) transmitted by facsimile or electronic mail, in either case (facsimile or electronic mail) with receipt confirmed by the recipient or followed by a confirmation copy by mail as provided in (iii), and in each case (clauses (i) through (iv)) addressed to the recipient Party as set forth below, unless changed by notice so given:

If to NHSc:
Nestec Ltd.
Avenue Nestlé 55
1800 Vevey
Switzerland
Attention:  General Counsel, Nestlé Health Science

with a copy to:

Mayer Brown LLP
1221 Avenue of the Americas
New York, NY 10020
Attention: David A. Carpenter
Reb D. Wheeler

	
 
	
If to Aimmune:

Aimmune Therapeutics, Inc.
8000 Marina Boulevard, Suite 300
Brisbane, CA  94005
Attention: General Counsel

with a copy to:

Latham & Watkins LLP
140 Scott Road
Menlo Park, CA 94025
Attention: 
	
Patrick Pohlen

Judith Hasko

 

17

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

(A) with respect to any notice delivered pursuant to clauses (i) or (iv), such notice shall be deemed effective upon submission to such other Party, (B) with respect to any notice delivered pursuant to clause (ii), such notice shall be deemed effective the Business Day following the date of submission to the carrier, and (C) with respect to any notice delivered pursuant to clause (iii), such notice shall be deemed effective five (5) Business Days after the earlier of (x) confirmation of receipt by the recipient or (y) the date of submission of such facsimile or electronic mail, as applicable.  A Party may add, delete, or change the person or address to whom notices should be sent at any time upon written notice delivered to the other Party in accordance with this Section 9.3. 

Assignment

.  Neither this Agreement nor any of the rights or obligations hereunder may be assigned or transferred by either Party without the prior written consent of the other Party, such consent not to be unreasonably withheld, delayed or conditioned; provided, however, that either Party may, without the other Party’s consent, but with written notice to the other Party, assign or transfer all of its rights and obligations hereunder to any Affiliate or to a Third Party with which it is combined, or which acquires such Party’s shares or assets, pursuant to a Change of Control of such Party.  The assigning Party shall in any event remain responsible for and liable hereunder with respect to the acts and omissions of the assignee in the performance of this Agreement.  This Agreement shall inure to the benefit of and be binding on the Parties’ successors and assigns.  Any assignment or transfer in violation of the foregoing shall be null and void and wholly invalid, the assignee or transferee in any such assignment or transfer shall acquire no rights whatsoever, and the non‐assigning non‐transferring Party shall not recognize, nor shall it be required to recognize, such assignment or transfer. 

Further Assurances

.  Each Party agrees, at its own expense, to do, or procure the doing of, all such further acts and things and shall execute and deliver such other agreements, certificates, instruments and documents as are reasonably necessary in order to give full effect to this Agreement.

Waivers and Modifications

.  No waiver, modification, release or amendment of any obligation under or provision of this Agreement shall be valid or effective unless in writing and signed by all Parties hereto.  The failure of any Party to insist on the performance of any obligation hereunder shall not be deemed to be a waiver of such obligation.  Waiver of any provision hereunder or of any breach of any provision hereof shall not be deemed to be a continuing waiver or a waiver of any other breach of such provision (or any other provision) on such occasion or any succeeding occasion.

Choice of Law

.  This Agreement (and any claims or disputes arising out of or relating hereto or to the transactions contemplated hereby or to the inducement of any Party to enter herein or therein, whether for breach of contract, tortious conduct or otherwise and whether predicated on common law, statute or otherwise) shall be governed by, enforced, and shall be construed in accordance with the laws of the State of New York, without regard to its conflicts of law provisions.

Injunctive Relief

.  Notwithstanding anything herein to the contrary, each party shall be entitled to seek injunctive relief and specific performance (including but not limited to any relief or recovery under this Agreement) in any court of competent jurisdiction in the world.

18

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Publicity

.  Upon execution of this Agreement, each Party may issue a press release announcing the existence of this Agreement in a form, and containing substance, to be agreed in good faith between the Parties (such agreement not to be unreasonably withheld or delayed by either Party).  Subject to Section 6.4, each Party agrees not to issue any other press release or other public statement disclosing other information relating to this Agreement or the transactions contemplated hereby without the prior written consent of the other Party.    Each Party shall use all reasonable efforts to provide to the other Party a copy of any public announcement regarding this Agreement or the subject matter hereof as soon as reasonably practicable under the circumstances prior to its scheduled release (but in no event less than three (3) Business Days prior to its scheduled release, unless a shorter period is required to comply with applicable Law under the circumstances).  Each Party shall have the right to expeditiously review and recommend changes to any such announcement and the Party whose announcement has been reviewed shall remove any Confidential Information of the reviewing Party that the reviewing Party reasonably deems to be inappropriate for disclosure except to the extent such disclosure is required by applicable Law or rules of a securities exchange or the Securities and Exchange Commission or the securities regulators of any state or other jurisdiction.  The contents of any announcement or similar publicity, which has been reviewed and approved by the reviewing Party, (including the press release referred to at the beginning of this Section 9.9), and any filing with the Securities and Exchange Commission, can be re‐released by either Party without a requirement for re‐approval.  

Relationship of the Parties

.  Each Party is an independent contractor under this Agreement.  Nothing herein is intended or is to be construed so as to constitute Aimmune and NHSc as partners, agents or joint venturers.  Neither Party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any Third Party.  There are no express or implied third party beneficiaries hereunder.

Entire Agreement

.  The Parties agree that this Agreement and the attached Exhibits, as amended as of the Effective Date, constitutes the entire agreement between the Parties as to the subject matter of this Agreement, and hereby supersedes all prior negotiations, representations, agreements and understandings (whether written or verbal) regarding the same, including the Original Agreement.  Each Party acknowledges that in entering into this Agreement it has not relied on, nor shall it be entitled to rely upon, any representation, warranty, collateral contract or other assurances made by or on behalf of the other Party except for those which are expressly set forth in this Agreement.

Counterparts

.  This Agreement may be executed in two or more counterparts, including counterparts delivered by facsimile or other electronic transmission, with the same effect as if both Parties had signed the same document.  All such counterparts shall be deemed an original, shall be construed together and shall together constitute one and the same instrument.

Exports

.  Each Party agrees not to export or re‐export, directly or indirectly, any information, technical data, the direct product of such data, samples or equipment received or generated under this Agreement in violation of any applicable export control Laws.

19

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Amendments

.  Any amendment of this Agreement shall not be binding on the Parties unless set out in writing, expressed to amend this Agreement and signed by authorized representatives of each of the Parties.

Interpretation

.  Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word “or” is used in the inclusive sense (and/or).  The captions of this Agreement are for convenience of reference only and in no way define, describe, extend, or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement.  The term “including,” “include,” or “includes” as used herein shall mean including, without limiting the generality of any description preceding such term.  Unless the context requires otherwise, (i) any definition of or reference to any agreement, instrument or other document herein will be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein), (ii) any reference to any applicable Laws herein will be construed as referring to such Laws as from time to time enacted, repealed or amended, (iii) any reference herein to any person will be construed to include the person’s successors and permitted assigns, (iv) the words “herein”, “hereof” and “hereunder”, and words of similar import, will be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (v) any reference herein to the words “mutually agree” or “mutual written agreement” will not impose any obligation on either Party to agree to any terms relating thereto relating to such terms except as such Party may determine in such Party’s sole discretion, (vi) all references herein to Sections or Exhibits will be construed to refer to Sections and Exhibits to this Agreement, (vii) the word “days” means calendar days unless otherwise specified, (viii) except as otherwise expressly provided herein all references to “$” or “dollars” refer to the lawful money of the U.S., and (ix) the words “copy” and “copies” and words of similar import when used in this Agreement include, to the extent available, electronic copies, files or databases containing the information, files, items, documents or materials to which such words apply.  The headings of each Article and Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Article or Section.  Each Party represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof.  In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption will apply against the Party which drafted such terms and provisions.  The language in this Agreement is to be construed in all cases according to its fair meaning.

[Signature page follows]

20

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their respective duly authorized officers.

AIMMUNE THERAPEUTICS, INC.

	
 
	
By:
	
/s/ Jayson Dallas, M.D.
(Signature)

	
 
	
Name:
	
Jayson Dallas, M.D.

	
 
	
Title:
	
President and CEO

 

NESTEC LTD. 

	
 
	
By:
	
/s/ Claudio Kuoni
(Signature)

	
 
	
Name:
	
Claudio Kuoni

	
 
	
Title:
	
General Counsel Nestle Health Science

 

Solely for purposes of Section 9.11:  

NESTLÉ HEALTH SCIENCE S.A.

	
 
	
By:
	
/s/ Claudio Kuoni
(Signature)

	
 
	
Name:
	
Claudio Kuoni

	
 
	
Title:
	
General Counsel

 

 

21

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Exhibit A

Development Programs

The treatment of allergies to the following foods:

 

Peanut, including the program designated AR-101

[***]

 

 

 

 

 

 

 

 

 

 

22

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00292-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00292-of-00352.parquet"}]]