Document:

EXHIBIT 10.14

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

EXECUTION VERSION

 

DISTRIBUTION AND SUBLICENSE AGREEMENT

 

THIS DISTRIBUTION AND SUBLICENSE AGREEMENT (this “Agreement”), dated as of February 1, 2016 (the “Effective Date”), by and between BRAEBURN PHARMACEUTICALS, INC., a corporation formed under the laws of Delaware (“Braeburn”), and KNIGHT THERAPEUTICS INC., a corporation incorporated under the laws of Canada (“Knight”).

 

RECITALS

 

WHEREAS reference is made to that certain License Agreement, dated as of December 14,2012, by and between Titan Pharmaceuticals, Inc. (“Titan”) and Braeburn, as amended by that certain first amendment dated May 28,2013, as further amended by that certain second amendment dated July 2,2013, as further amended by that certain third amendment dated November 12, 2013, and as assigned to Braeburn pursuant to that certain letter of assignment, dated May 28,2015, from Braeburn Pharmaceuticals BVBA SPRL and acknowledged by Titan (as amended, the “Titan Agreement”);

 

WHEREAS pursuant to the terms and conditions of the Titan Agreement, Braeburn owns or licenses all right, title and interest in and to certain patents, trademark(s) and Know-How relating to Braeburn’s buprenorphine subdermal implant known as Probuphine;

 

WHEREAS Knight wishes to be appointed by Braeburn as exclusive distributor to offer to sell and sell the Sublicensed Products in the Territory and Braeburn is willing to grant such exclusive appointment; and

 

WHEREAS Knight wishes to procure the Sublicensed Products from Braeburn and Braeburn wishes to supply the Sublicensed Products to Knight, and the Parties agree to enter into a separate Supply Agreement providing therefor, as more particularly described herein.

 

NOW THEREFORE in consideration of the mutual promises and covenants contained herein, the Parties, intending to be legally bound, agree as follows:

 

1.                                      DEFINITIONS

 

1.1                               Definitions.  The following terms as used hereinafter in this Agreement shall have the meaning set forth in this Section:

 

“Accounting Standards” means, with respect to Knight, IFRS, and with respect to Braeburn, US GAAP, in each case, as generally and consistently applied by such Party.  Each Party shall promptly notify the other in the event that it changes the Accounting Standards pursuant to which its records are maintained, it being understood that each

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Party may only use internationally recognized accounting principles (e.g., IFRS or US GAAP) in general use for public company accounting and reporting in Canada, with respect to Knight, or the United States, with respect to Braeburn.

 

“Adverse Experience” means adverse drug experiences, as defined by 21 CFR Section 314.80 or any comparable law in the Territory, including any noxious and unintended response to a drug which occurs at doses normally used or tested for the diagnosis, treatment, or prevention of a disease or the modification of an organic function and any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.

 

“Affiliate” of a Party means (i) any corporation or business entity of which at least fifty percent (50%) of the securities or other ownership interests representing the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by a Party; (ii) any corporation or business entity which, directly or indirectly, owns, controls or holds at least fifty percent (50%) (or the maximum ownership interest permitted by law) of the securities or other ownership interests representing the equity, voting stock or general partnership interest of a Party; (iii) any corporation or business entity of which, directly or indirectly, an entity described in the immediately preceding subsection (ii) controls or holds at least fifty percent (50%) (or the maximum ownership interest permitted by law) of the securities or other ownership interests representing the equity, voting stock or general partnership interest of such corporation or entity; or (iv) any corporation or business entity of which a Party has the right to acquire, directly or indirectly, at least fifty percent (50%) of the securities or other ownership interests representing the equity, voting stock or general partnership interest thereof.  Notwithstanding the foregoing, Apple Tree Partners IV, L.P., ATP III, G.P., and their portfolio companies, other than Braeburn and its subsidiaries, shall not be deemed to be Affiliates of Braeburn under this Agreement unless and until this Agreement, the Sublicensed Product, any Subsequent Indication or any ROFN Product or any rights or obligations related hereto or thereto are assigned, transferred or conveyed to any of them.

 

“Agreement” has the meaning set forth in the initial paragraph of this Agreement.

 

“Applicable Laws” means any law, regulation, rule, guidance, order, judgment or decree having the force of law applicable to the Parties and their activities under this Agreement.

 

“Audit Disagreement” has the meaning set forth in Section 6.5(a)(ii).

 

“Braeburn” has the meaning set forth in the initial paragraph of this Agreement.

 

“Braeburn Indemnified Party” has the meaning set forth in Section 9.6.

 

“Braeburn Know-How” means all unpatented information and Data that are as of the Effective Date or become during the Term Controlled by Braeburn, including

 

2

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

discoveries, Improvements, processes, formulas, inventions, Know-How and trade secrets, to the extent necessary or useful for the development, manufacture, and/or Commercialization of a Sublicensed Product.  Braeburn Know-How does not include any Patent Rights.  Braeburn Know-How also includes all marketing authorizations and marketing approvals granted by Regulatory Authorities (e.g., approved NDAs, FNDs and related applications and other forms of marketing authorization) to and Controlled by Braeburn for the marketing of Sublicensed Products.  Such marketing authorizations and marketing approvals shall be deemed embodiments of Data and Braeburn Know-How.

 

“Braeburn Marks” means the marks owned or licensed by Braeburn set forth in Schedule A and any other marks Braeburn may adopt from time to time, for use for the Sublicensed Products which shall be deemed to automatically be incorporated into Schedule A.

 

“Braeburn Patents” means all Patent Rights in the Territory that are as of the Effective Date or become during the Term Controlled by Braeburn and that generically or specifically claim, or would be reasonably necessary for, the making, having made, use, offer for sale, sale or importation of the Sublicensed Products or claim any Improvements.

 

“Business Day” means any day other than (i) Saturday or Sunday or (ii) a day that is a legal holiday in either of Montreal, Quebec or New York, New York, or (iii) any other day on which banks in either of Montreal, Quebec or New York, New York are required to be closed.

 

“Calendar Quarter” means the three (3) month periods ending on March 31, June 30, September 30 and December 31 in each Calendar Year.

 

“Calendar Year” means, in respect of any particular year, the one (1) year period beginning on January 1 and ending on December 31.

 

“Commercialize” means marketing, using, distributing, Promoting, offering for sale, and selling the Sublicensed Products.

 

“Commercialization Plan” means [***].

 

“Commercially Reasonable Efforts” means, [***].

 

“Competitive Product” means any pharmaceutical product that (i) contains buprenorphine (in any form or formulation, including any pharmaceutically acceptable salts, esters, solvates, hydrates, polymorphs, crystal forms, prodrugs and tautomers) as an active ingredient and (ii) [***].

 

“Confidential Information” has the meaning set forth in Section 10.1.

 

3

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

“Control” means, with respect to any material, information, or intellectual property right, that a Party (i) owns or (ii) has a license to, and, in each case, has the ability to grant to the other Party access, a license, or a sublicense (as applicable) to the foregoing on the terms and conditions set forth in this Agreement without violating the terms of any then-existing agreement or other arrangement with any Third Party.

 

“Data” means any and all research data, pharmacology data, preclinical data, clinical data, medical chemistry, commercial, marketing, process development, manufacturing and other data or information, including investigator reports (both preliminary and final), statistical analyses, expert opinions and reports, and safety data, in each case generated from clinical or non-clinical studies, research or testing specifically related or directed to the Sublicensed Product(s), together with all documentation submitted, or required to be submitted, to a Regulatory Authority in association with a Regulatory Submission or similar application for a Sublicensed Product (excluding any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (CMC) data, or similar documentation).

 

“Data Package” has the meaning set forth in Section 2.9(a).

 

“Effective Date” means the date specified in the initial paragraph of this Agreement.

 

“EMA” has the meaning set forth in Section 3.5(a).

 

“Excluded Transaction” has the meaning set forth in Section 2.9(d).

 

“FDA” means the United States Food and Drug Administration and any successor agency having substantially the same functions.

 

“Field” means the Initial Indication and/or any Subsequent Indications for Sublicensed Products in the Territory.

 

“Final Royalty Period” has the meaning set forth in Section 6.3(c).

 

“Final Royalty True-Up Report” has the meaning set forth in Section 6.3(c).

 

“First Commercial Sale” means the first sale to a Third Party of a Sublicensed Product in the Territory for value after Regulatory Approval has been obtained in the Territory.

 

“Force Majeure” has the meaning set forth in Section 13.6.

 

“Government List” has the meaning set forth in Section 9.2(k).

 

“Governmental Authority” means any domestic or foreign entity exercising executive, legislative, judicial, regulatory or administrative functions of or pertaining to government, including any governmental authority, agency, department, board, commission, court, tribunal, judicial body or instrumentality of any union of nations,

 

4

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

federation, nation, state, municipality, county, locality or other political subdivision thereof.

 

“Health Canada” means Health Canada and any successor agency having substantially the same functions.

 

“IFRS” means, at any time, the International Financial Reporting Standards, promulgated by the International Accounting Standards Board, as amended, supplemented or replaced from time to time, and in general use for public company accounting and reporting in Canada.

 

“Improvements” means all modifications, alterations, improvements, any reformulation or line extension, other advances, enhancements, inventions and Know-How, patentable or otherwise, made, created, developed, discovered, conceived or reduced to practice by or on behalf of a Party and/or any of its Affiliates during the Term, that apply to Sublicensed Products, including developments in the manufacture, formulation, ingredients, preparation, presentation, means of delivery or administration, dosage, Indication, methods of use or packaging and/or sale of Sublicensed Products, including a process for manufacturing a Sublicensed Product, an intermediate used in such process, a formulation of a Sublicensed Product, or a use or Indication of a Sublicensed Product.  Notwithstanding anything in the preceding sentence, an Improvement shall not include Regulatory Approval to Commercialize a Sublicensed Product for a Subsequent Indication.

 

“Independent Expert” has the meaning set forth in Section 6.5(a)(ii).

 

“Indication” means any human disease or condition, or sign or symptom of a human disease or condition.

 

“Initial Indication” means the use of a Sublicensed Product for the treatment of opioid addiction.

 

“Initial Term” has the meaning set forth in Section 11.1.

 

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

 

“Knight” has the meaning set forth in the initial paragraph of this Agreement.

 

“Knight Indemnified Party” has the meaning set forth in Section 9.5.

 

“Knight Offer” has the meaning set forth in Section 2.9(b).

 

“Knight Sales Force” means the professional trained sales force employed or retained (as consultants, contract sales force or otherwise) by Knight to support its obligations under this Agreement.

 

5

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

“Knight Waiver Notice” has the meaning set forth in Section 2.9(b).

 

“Know-How” means any non-public information, ideas, Data, inventions, works of authorship, trade secrets, technology, or materials, including formulations, molecules, assays, reagents, compounds, compositions, human or animal tissue, samples or specimens, and combinations or components thereof, whether or not proprietary or patentable, and whether stored or transmitted in oral, documentary, electronic or other form, including all Regulatory Submissions.

 

“Launch” means the First Commercial Sale of a Sublicensed Product in the Territory.

 

“Losses” means any and all damages of any kind whatsoever (including all incidental, consequential, statutory and treble damages), awards, deficiencies, settlement amounts, defaults, assessments, fines, dues, penalties, judgments (including penalties imposed by any Governmental Authority), costs, fees, liabilities, obligations, taxes, liens, losses, lost profits and expenses (including court costs, interest and reasonable fees of attorneys, accountants and other experts) and other monetary obligations arising out of or resulting from claims or judgments, arbitral awards, including amounts paid in settlement of claims, judgments, legal (including judicial, arbitral and administrative) proceedings and the like, incurred or otherwise payable to Third Parties.

 

“NDA Transfer Date” means the NDA Transfer Date as such term is defined in the Titan Agreement.

 

i.                  “Net Sales” means [***].

 

“Non-Renewal Notice” has the meaning set forth in Section 11.1.  “OFAC” has the meaning set forth in Section 9.2(k).

 

“Party” means either Braeburn or Knight and “Parties” means both Braeburn and Knight.

 

“Patent Rights” means any of the following, whether existing now or in the future, in the Territory: (i) patents and patent applications (including provisional applications); (ii) all patent applications filed either from such patents or patent applications or from an application claiming priority from either of these, including continuations, continuations-in-part, divisionals, converted provisionals, continued prosecution applications, and substitute applications; (iii) any patents issued based on or claiming priority to any such patent applications in (i) and (ii); (iv) any and all extensions or restorations by existing or future extension or restoration mechanisms, including adjustments, revalidations, renewals, reissues, reexaminations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications in (i), (ii) and (iii); (v) any similar rights, including so-called pipeline protection, or any importation, revalidation, confirmation or introduction patent or registration patent or

 

6

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

patents of addition to any of such foregoing patents or patent applications; and (vi) any other patents and patent applications that dominate the foregoing patents.

 

“Patriot Act Offense” has the meaning set forth in Section 9.2(k).

 

“Promotion” means those activities normally undertaken by a pharmaceutical company to implement promotion plans and strategies aimed at encouraging the appropriate use of a particular prescription pharmaceutical product under a common trademark, up to the point of offering a product for sale, in each case, in accordance with Applicable Law.  When used as a verb, “Promote” means to engage in such activities.

 

“Quality Agreement” has the meaning set forth in Section 7.2.

 

“Recall” has the meaning set forth in Section 5.6.

 

“Regulatory Approval” means with respect to a pharmaceutical or biological product or medical device in a country or regulatory jurisdiction, any and all approvals, licenses, permits, certifications, registrations or authorizations from the relevant Regulatory Authority in such regulatory jurisdiction that is specific to such product and necessary for the Promotion and commercial sale of such product in such country or regulatory jurisdiction (including pricing and/or reimbursement approval in any country in which pricing and/or reimbursement approval is required by Applicable Laws).

 

“Regulatory Authority” means, in a particular country or regulatory jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval and/or, to the extent required in such country or regulatory jurisdiction, pricing or reimbursement approval of a Sublicensed Product in such country or regulatory jurisdiction.

 

“Regulatory Submissions” means all applications, filings, dossiers, modifications, amendments, supplements, revisions, reports, submissions, authorizations and approvals, and any reports or amendments necessary to maintain Regulatory Approvals.

 

“Renewal Term” has the meaning set forth in Section 11.1.

 

“ROFN Negotiation Period” has the meaning set forth in Section 2.9(a).

 

“ROFN Product” means a product, other than a Sublicensed Product, Controlled by Braeburn or its Affiliates during the Term, rights to which have not been licensed or sublicensed in the Territory to a Third Party prior to the Term.

 

“Royalties” has the meaning set forth in Section 6.1.

 

“Royalty Report” has the meaning set forth in Section 6.3(a).

 

“Royalty True-Up” has the meaning set forth in Section 6.3(a)(iii).

 

7

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

“SDEA” means the Safety Data Exchange Agreement to be entered into by the Parties in accordance with the terms and conditions of this Agreement and the Titan Agreement.

 

“Sublicensed Product” means that certain buprenorphine subdermal implant licensed by Braeburn and known as of the Effective Date as Probuphine for use in the Field, including all Improvements thereto.

 

“Sublicensed Product Label(ing)” has the same meaning as defined in the United States Food, Drug, and Cosmetic Act of 1938, as amended, and the rules and regulations promulgated thereunder, or any successor act, as the same shall be in effect from time to time, and as interpreted by the FDA, and any analogous Applicable Laws as interpreted by an applicable Regulatory Authority in the Territory.

 

“Sublicensed Product NDS” means a New Drug Submission that is submitted to Health Canada to apply for Regulatory Approval of a Sublicensed Product for the Initial Indication.

 

“Sublicensed Product Trademark(s)” means the Probuphine trademark, owned by Titan, and licensed to Braeburn under the Titan Agreement, and all related domain names and other trademark related rights, and/or any other trademark that Braeburn may apply to register in the Territory if such alternate trademark is selected for use in the Promotion of a Sublicensed Product by the Parties under this Agreement.

 

“Subsequent Indication” means the use of a Sublicensed Product for the treatment of an Indication that is not the Initial Indication.  For clarity, references herein to a “Subsequent Indication in the Territory” mean a Subsequent Indication as set forth in a Regulatory Approval for Sublicensed Products in the Territory, and Knight’s rights and obligations hereunder with respect to Subsequent Indications following Launch refer to Subsequent Indications as set forth in a Regulatory Approval for Sublicensed Products in the Territory.

 

“Supply Agreement” has the meaning set forth in Section 7.1.

 

“Supply Price” has the meaning set forth in Section 6.2.

 

“Term” means the Initial Term and any Renewal Term, as applicable.

 

“Territory” means Canada.

 

“Third Party” means any person other than the Parties and their Affiliates.  “Third Party Claims” has the meaning set forth in Section 9.5.  “Third Party Offer” has the meaning set forth in Section 2.9(b).  “Third Party Transaction” has the meaning set forth in Section 2.9(b).

 

“Third Party Transaction Notice” has the meaning set forth in Section 2.9(b).

 

8

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

“Titan” has the meaning set forth in the recitals to this Agreement.

 

“Titan Agreement” has the meaning set forth in the recitals to this Agreement.

 

“US GAAP” means, at any time, then-applicable United States generally accepted accounting principles.

 

1.2                               Other Definitional and Agreement References.  References to any agreement, contract, statute, act, or regulation are to that agreement, contract, statute, act, or regulation as amended, modified or supplemented from time to time in accordance with the terms hereof and thereof.

 

1.3                               Ambiguities.  Ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.

 

1.4                               Sections and Headings.  The term “Section” refers to the specified Section of this Agreement, unless otherwise specified.  Headings and captions of the Sections hereof are for convenience only and are not to be used in the interpretation of this Agreement.

 

1.5                               United States Dollars.  References in this Agreement to “Dollars” or “$” shall mean the legal tender of United States, unless otherwise noted.  Except as otherwise provided in this Agreement, all payments required to be made by or on behalf of a Party under this Agreement shall be paid in United States Dollars, and to the extent necessary, shall be converted into United States Dollars using the spot rate of exchange for conversion into United States Dollars as published in The Wall Street Journal on the Business Day prior to the date any such payment is made.

 

1.6                               Date References.  References from or through any date mean, unless otherwise specified, from and including or through and including, respectively.

 

1.7                               Gender and Person.  Words of one gender include the other gender.  Unless the context otherwise requires, references to a “person” in this Agreement include any individual, corporation, company, partnership, joint venture, trust, governmental body, authority, or other entity.

 

1.8                               Include, Includes, Including.  Whenever the words “include”, “includes” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation”, whether or not they are in fact followed by those words or words of like import.

 

1.9                               Knowingly.  The term “knowingly” as used in this Agreement means actual knowledge or reasonable reason to suspect.

 

9

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

1.10                        No Strict Construction.  This Agreement has been prepared jointly and shall not be strictly construed against either Party.

 

1.11                        Number of Days.  Whenever this Agreement refers to a number of days, unless otherwise specified, such number shall refer to calendar days.

 

1.12                        Party References.  Reference to any Party includes the successors and permitted assigns of that Party.

 

1.13                        Singular/Plural.  Words using the singular or plural number also include the plural or singular number, respectively.

 

2.                                      GRANT OF RIGHTS

 

2.1                               Effectiveness.  This Agreement shall be effective as of the Effective Date, but the Parties agree and acknowledge that certain rights and obligations under this Agreement shall not become effective until the NDA Transfer Date. Notwithstanding the foregoing, the Parties agree and acknowledge that following the Effective Date, Knight may, to the extent permitted under the Titan Agreement, undertake such activities as are reasonably necessary to prepare for the NDA Transfer Date, provided that Knight shall keep Braeburn reasonably informed with respect to any such activities, and Braeburn shall reasonably cooperate with and assist Knight in any such activities.

 

2.2                               General.  Pursuant to Section 2.6 of the Titan Agreement, this Agreement is subject to, and Knight agrees that it shall be bound by, the terms and conditions of the Titan Agreement, including the provisions relating to payments set forth in Article 6 of the Titan Agreement.  In the event of any conflict between the terms and conditions of this Agreement and the terms and conditions of the Titan Agreement, the terms and conditions of the Titan Agreement shall govern and control.

 

2.3                               Appointment; Sublicense.  Subject to the terms and conditions of this Agreement and the Titan Agreement, Braeburn, on behalf of itself and its Affiliates, hereby (a) appoints Knight as its exclusive distributor of Sublicensed Products in the Territory and in the Field for the Term, and (b) grants to Knight, and Knight hereby accepts, for the Term, and for the Territory and in the Field, an exclusive sublicense under the Braeburn Patents and Braeburn Know-How to Commercialize the Sublicensed Products.  For the avoidance of doubt, references to “Sublicensed Products” in this Section 2.3 include the Sublicensed Products for the Initial Indication, any Subsequent Indications, and Sublicensed Products with any Improvements.

 

2.4                               Sublicensing.  Subject to the terms and conditions of this Agreement and the Titan Agreement, Knight may sublicense its rights granted hereunder to any Affiliate of Knight or any Third Party, or use any sub-distributors or Third Party contractors to exercise its rights or fulfill its obligations hereunder.  Knight shall advise Braeburn in advance of any proposed sublicense and consider in good faith Braeburn’s comments with respect

 

10

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

thereto.  Without limiting the foregoing, and notwithstanding anything else contained herein to the contrary, Knight may not make, grant, enter into or otherwise commit to any sublicense of its rights granted hereunder, including to any Affiliate, prior to the NDA Transfer Date without the prior written consent of Braeburn.  All sublicense agreements, distribution or other arrangements or agreements shall be subject to and consistent with the terms and conditions of this Agreement and the Titan Agreement, and any sublicensees, distributors or other party shall be bound by the terms and conditions of this Agreement and the Titan Agreement, including the provisions relating to payments set forth in Article 6 of the Titan Agreement.  Knight assumes full responsibility for any actions taken or any failures to act by any sublicensee, distributor or other person and any of the expenses, costs, or fees incurred by any sublicensee, distributor or other person.  In the event Knight grants a sublicense to an Affiliate, any payment due to Braeburn under this Agreement must be received in its full amount by Braeburn in the United States, and in United States Dollars, without any tax withholding or tax deduction therefrom, except as provided under Section 13.1.

 

2.5                               No Implied Licenses.  All rights not specifically granted to Knight herein are reserved and retained by Braeburn, including, without limitation, with respect to the period between the Effective Date and the NDA Transfer Date.  Neither Party grants to the other Party any right or license to use any of its intellectual property, Know-How or other proprietary information, materials or technology, or to practice any of its patent, trademark, or trade dress rights, except as expressly set forth in this Agreement.  Except as otherwise permitted in this Agreement, Knight shall not grant any license to, or permit or authorize, any Third Party to Promote Sublicensed Products in the Territory without the prior written consent of Braeburn.

 

2.6                               Restriction on Knight Sales.  Knight shall not, either directly or indirectly (including through any Affiliate, representative, agent or sublicensee) knowingly: (i) sell or otherwise dispose of Sublicensed Products to any Third Party outside the Territory; (ii) sell or otherwise dispose of Sublicensed Products to any Third Party within the Territory for the purpose of sale or other disposition to any Third Party outside the Territory; (iii) knowingly distribute any Sublicensed Products for sale or use outside the Territory; or (iv) supply any Third Party that has distributed or offered to distribute Sublicensed Products outside the Territory after Knight has knowledge that said Third Party has distributed or offered to distribute Sublicensed Products outside the Territory.  If Knight knows or has reason to suspect that a Third Party to whom Knight sells or otherwise disposes of Sublicensed Products is engaged in the sale or distribution of Sublicensed Products for use outside the Territory, then Knight shall (A) within [***] Business Days after gaining knowledge of, or reason to suspect, such activities notify Braeburn thereof and provide all information in Knight’s possession that Braeburn may reasonably request concerning such activities, and (B) take all reasonable steps (including cessation of sales, directly or indirectly, to such Third Party) necessary to limit such sale or other disposition for use outside the Territory.  All inquiries or orders received by Knight for Sublicensed Product to be delivered outside the Territory shall be referred to

 

11

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Braeburn.  Knight shall use Commercially Reasonable Efforts to cause each of its Affiliates, representatives, agents and sublicensees (other than Braeburn) to comply with the obligations of Knight under this Section 2.6.  For the avoidance of doubt, references to “Sublicensed Products” in this Section 2.6 include the Sublicensed Products for the Initial Indication, any Subsequent Indications, and Sublicensed Products with any Improvements.

 

2.7                               Restriction on Braeburn Sales.  Braeburn shall not knowingly: (i) solicit or accept orders for distribution of Sublicensed Products to a Third Party for sale or distribution in the Territory; (ii) distribute any Sublicensed Products for sale or use in the Territory; or (iii) supply any Third Party that has distributed or offered to distribute Sublicensed Products in the Territory after Braeburn has knowledge that said Third Party has distributed or offered to distribute Sublicensed Products obtained from Braeburn in the Territory.  For the avoidance of doubt, references to “Sublicensed Products” in this Section 2.7 include the Sublicensed Products for the Initial Indication, any Subsequent Indications, and Sublicensed Products with any Improvements.

 

2.8                               Performance by Affiliates.  The Parties agree that their respective rights and obligations may be exercised or performed by any of their Affiliates; provided, however, that each Party shall (a) provide prior written notice to the other Party of such exercise or performance by any such Affiliate, (b) be fully responsible and liable for the actions and omissions of such Affiliate(s) in the exercise or performance of such rights and obligations, and (c) ensure that such Affiliate(s) comply with the terms and conditions of this Agreement.

 

2.9                               Right of First Negotiation.

 

(a)                                 If, at any time during the Term, Braeburn or any of its Affiliates intends to license or sublicense its right to develop or Commercialize a ROFN Product in the Territory (or any part thereof) to any Third Party in order to permit such Third Party to develop or Commercialize the ROFN Product in the Territory (but not including any Excluded Transaction), then prior to negotiating with any Third Party to license or sublicense such development or commercialization right, Braeburn shall first notify Knight of its intent, provide to Knight a copy of material data with respect to the development and commercialization of such ROFN Product in Braeburn’s possession and Control not previously provided to Knight and that shall be reasonably sufficient to assess the ROFN Product (the “Data Package”), and shall, unless Knight notifies Braeburn in writing during the ROFN Negotiation Period that it is not interested in acquiring rights to a particular ROFN Product (a “Knight Waiver Notice”), negotiate solely and in good faith with Knight for [***]) with respect to mutually agreeable binding financial terms (“Binding Financial Terms”) for the acquisition by Knight, by license, sublicense, or otherwise, of the right to develop or Commercialize the ROFN Product in the Territory (or the applicable part thereof).  [***].  All

 

12

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

information provided by Braeburn to Knight pursuant to this Section 2.9 shall constitute Confidential Information of Braeburn.

 

(b)                                 If Knight delivers a Knight Waiver Notice regarding a ROFN Product, then Braeburn may subsequently offer a Third Party, or solicit offers from Third Parties for, and take any action in furtherance of (including providing information, participating in discussions, and/or engaging advisors or agents), a license, sublicense or other transfer of its rights to develop or Commercialize such ROFN Product in the Territory (or any part thereof) (a “Third Party Offer”), and Braeburn shall have no further obligations to Knight regarding such ROFN Product.

 

(c)                                  If Knight does not provide a Knight Waiver Notice and the Parties do not sign a letter related the Binding Financial Terms with respect to the development or commercialization of a ROFN Product during the ROFN Negotiation Period, then Braeburn may [***].

 

(d)                                 Notwithstanding anything contained herein to the contrary, it is agreed and acknowledged that the rights and obligations of Knight and Braeburn under this Section 2.9 shall apply only to potential licenses or sublicenses of Braeburn’s right to develop or Commercialize a ROFN Product in the Territory (or any part thereof) without a grant of rights with respect to the ROFN Product in any other country or jurisdiction (or any part thereof).  For clarity, the rights and obligations of Knight and Braeburn under this Section 2.9 shall not apply to (i) any sale or change of control of Braeburn or any of its Affiliates, (ii) any sale or transfer of all or substantially all of the assets, business or operations of Braeburn or any of its Affiliates, or all or substantially all of the business or operations of Braeburn or any of its Affiliates relating to any ROFN Product, or (iii) any license, sublicense or other transfer of Braeburn’s right to develop or Commercialize a ROFN Product that relates to a geographic territory that includes the Territory and at least one other country (each of (i)-(iii), without limitation, an “Excluded Transaction”).

 

2.10                        Non-Competition.

 

(a)                                 During the Term, Knight will not Promote, or permit its Affiliates to Promote, market or sell a Competitive Product in the Territory, or acquire, or permit its Affiliates to acquire, directly or indirectly any rights or interest in or to any Competitive Product that is being Promoted, marketed or sold in the Territory, if such Competitive Product has Regulatory Approval for, or is otherwise not prohibited by a Regulatory Authority from being marketed for, either the Initial Indication or a Subsequent Indication other than Sublicensed Product sublicensed to Knight under this Agreement. Notwithstanding anything in the preceding sentence, Knight shall only be prohibited from Promoting, marketing or selling a Competitive Product for a Subsequent Indication if there is FDA Regulatory

 

13

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Approval for such Subsequent Indication prior to such time as Knight begins to Promote, market or sell such Competitive Product.

 

(b)                                 During the Term, Braeburn will not Promote, or permit its Affiliates to Promote, market or sell a Competitive Product in the Territory, or acquire, or permit its Affiliates to acquire, directly or indirectly any rights or interest in or to any Competitive Product that is being Promoted, marketed or sold in the Territory.

 

(c)                                  Subject to Section 2.9, nothing in this Section 2.10 shall prevent either party from marketing, in the Territory, pharmaceutical products other than Sublicensed Products and Competitive Products, including pharmaceutical products that contain buprenorphine with a treatment duration of one week or one month.

 

3.                                      REGULATORY AND DEVELOPMENT

 

Following the NDA Transfer Date:

 

3.1                               General.  Subject to the terms and conditions of this Agreement, Knight shall during the Term use Commercially Reasonable Efforts to obtain and maintain Regulatory Approval in the Territory for the Sublicensed Products for (a) the Initial Indication and (b) any Subsequent Indication that receives Regulatory Approval in any jurisdiction.  Without limiting the foregoing, Knight shall file or cause to be filed with Health Canada a Sublicensed Product NDS with respect to the Sublicensed Products and the Initial Indication [***]. Knight will be solely responsible for all costs associated with, or required for the approval of, the Sublicensed Products by Health Canada and other applicable Regulatory Authorities in the Territory.  Knight shall notify Braeburn of all Regulatory Submissions relating to a Sublicensed Product in the Territory, and provide Braeburn with (i) a written semiannual report summarizing in reasonable detail Knight’s activities and progress related to the development of the Sublicensed Products in the Territory, including information regarding the status of Regulatory Submissions filed and intended to be filed with Regulatory Authorities and Regulatory Approvals in the Territory, (ii) a copy of any annual reports submitted to Regulatory Authorities by or on behalf of Knight with respect to the Sublicensed Products in connection with the periodic reporting requirements set forth by Applicable Laws, and (iii) such other information as may be reasonably requested by Braeburn or required under the Titan Agreement.  [***].

 

3.2                               Regulatory Submissions.  With respect to the Commercialization of the Sublicensed Products in the Territory:

 

(a)                                 Unless otherwise required by Applicable Law, any Regulatory Approvals and all Regulatory Submissions relating to Sublicensed Products in the Territory shall be filed, owned and held in the name of Knight.

 

(b)                                 Knight shall be solely responsible, at its expense, and shall use Commercially Reasonable Efforts to timely prepare, file, prosecute, and maintain all Regulatory

 

14

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Submissions relating to Sublicensed Products in the Territory, including any reports or amendments necessary to maintain Regulatory Approvals, and for seeking any revisions of the conditions of each Regulatory Approval.

 

(c)                                  Knight shall have sole authority and responsibility and shall use Commercially Reasonable Efforts to develop, modify, seek and/or obtain any necessary Regulatory Approvals of any Sublicensed Product Labeling, packaging, advertising or other promotional or informational materials used in connection with Sublicensed Products in the Territory, and Promotional Materials and for determining whether the same requires Regulatory Approval. Braeburn shall provide to Knight copies of all material FDA Regulatory Submissions in its possession and Control reasonably related to the Sublicensed Products.

 

(d)                                 Knight will be the primary contact with the Regulatory Authorities in the Territory and shall be solely responsible for all communications with such Regulatory Authorities that relate to any Regulatory Submission relating to Sublicensed Products in the Territory prior to and after any Regulatory Approval.

 

(e)                                  Subject to the terms and conditions of this Agreement, Knight may file any submissions that are intended to change or modify Sublicensed Product Labeling or prescribing information approved by the applicable Regulatory Authority for, or the Indications of, Sublicensed Products in the Territory provided that, except as required by Applicable Laws, it provides to Braeburn a draft of such submission at least [***] Business Days prior to planned submission to the applicable Regulatory Authority and gives prompt and reasonable consideration to any comments Braeburn may have.

 

(f)                                   To the extent Braeburn reasonably believes that a filing or submission relating to Sublicensed Products in the Territory is required by Applicable Laws in order to sell or continue selling the Sublicensed Products, Braeburn shall notify Knight in writing.  If Knight decides not to prepare such filing or submission, it shall promptly notify Braeburn of such decision and Braeburn shall, acting reasonably, be entitled to prepare such filing or submission, [***], to be filed or submitted by Knight; provided that Braeburn shall use good faith efforts to include any comments of Knight in such filing or submission.

 

(g)                                  Knight shall permit Braeburn to access, and shall provide Braeburn on a timely basis with the right to cross-reference and use in exercising its rights and performing its obligations hereunder with respect to Sublicensed Products in the Territory and for Braeburn to use in connection with the development and commercialization of Sublicensed Products outside of the Territory, any and all Regulatory Submissions related to the Sublicensed Products Controlled by Knight.  At the request of Braeburn and to the extent legally permitted and in accordance with the terms and conditions of this Agreement, Knight shall notify the appropriate Regulatory Authorities, as applicable, of Braeburn’s right to

 

15

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

reference such Regulatory Submissions in regulatory submissions filed by Braeburn in accordance with this Agreement.

 

(h)                                 Braeburn shall permit Knight to access, and shall provide Knight on a timely basis with the right to cross-reference and use in exercising its rights and performing its obligations hereunder with respect to Sublicensed Products in the Territory (including for Knight to use in connection with its Commercialization of Sublicensed Products in the Territory), any and all Regulatory Submissions related to the Sublicensed Products Controlled by Braeburn.  At the request of Knight and to the extent legally permitted and in accordance with the terms and conditions of this Agreement, Braeburn shall notify the appropriate Regulatory Authorities in the Territory of Knight’s right to reference such Regulatory Submissions in regulatory submissions filed by Knight in accordance with this Agreement.

 

3.3                               Regulatory Correspondence.  Each Party shall notify the other Party within [***] of its receipt of information that: (i) raises any concern regarding the safety of any Sublicensed Product(s); (ii) concerns suspected or actual tampering, counterfeiting or contamination or other similar problems with respect to any Sublicensed Product(s); (iii) is reasonably likely to lead to a Recall or market withdrawal of any Sublicensed Product(s); or (iv) concerns any ongoing or potential investigation, inspection, detention, seizure or injunction by a Regulatory Authority involving any Sublicensed Product(s).  Each Party shall provide the other Party with copies of any such information.  In the event that a Party receives any material regulatory letter requiring a response, the other Party will cooperate fully with the receiving Party in preparing such response and will promptly provide the receiving Party with any data or information reasonably required by the receiving Party in preparing any such response.

 

3.4                               Other Covenants of Knight.  In addition to its other obligations, commitments and undertakings set out in this Agreement, Knight agrees to:

 

(a)                                 [***] related to the Commercialization of the Sublicensed Products in the Territory;

 

(b)                                 use Commercially Reasonable Efforts to obtain pricing and, if applicable, reimbursement approval for the Sublicensed Products in the Territory;

 

(c)                                  [***] of the Sublicensed Products to customers in the Territory; and

 

(d)                                 prepare an annual marketing and sales plan relating to the Sublicensed Products in the Territory.

 

3.5                               Other Covenants of Braeburn.  In addition to its other obligations, commitments and undertakings set out in this Agreement, Braeburn agrees to:

 

16

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(a)                                 provide Knight with all relevant documentation relating to the submissions for Regulatory Approval to the FDA or the European Medicines Agency (“EMA”) for the Sublicensed Products within [***] from such FDA or EMA submissions;

 

(b)                                 where applicable, provide reasonable assistance to Knight with Regulatory Submissions concerning Sublicensed Products in the Territory;

 

(c)                                  provide full assistance and cooperation with respect to securing intellectual property protection in the Territory for the Sublicensed Products;

 

(d)                                 assume the reasonable costs of intellectual property filings, procurement and maintenance for all intellectual property applications and registrations associated with the Sublicensed Products in the Territory;

 

(e)                                  not assign the intellectual property associated with Sublicensed Products to any Third Party; and

 

(f)                                   coordinate Launch activities with Knight, including pharmacovigilance, pricing, reimbursement, positioning and health care conferences; and

 

(g)                                  promptly provide copies of marketing and sales materials related to the Sublicensed Products used by Braeburn in the United States.

 

3.6                               For avoidance of doubt, in the event that the Initial Indication does not receive Regulatory Approval, Knight shall continue to benefit from the rights granted hereunder with respect to Subsequent indications.

 

3.7                               For the avoidance of doubt, except as expressly provided herein, Knight’s rights and obligations under this Section 3 shall apply to any Subsequent Indication as contemplated by Section 3.1; provided, that any such rights and obligations with respect to Subsequent Indications following Launch shall apply only to Subsequent Indications that receive Regulatory Approval in the Territory

 

4.                                      TRADEMARKS

 

4.1                               Trademark License.  Subject to the terms and conditions of this Agreement, Braeburn hereby grants to Knight, for the Term, an exclusive, fully paid, right and license to use the Braeburn Marks and Sublicensed Product Trademarks on or in connection with the Commercialization of Sublicensed Products in the Territory following the NDA Transfer Date. All representations of the Braeburn Mark(s) and Sublicensed Product Trademark(s) that Knight intends to use, if not previously approved by Braeburn, will first be submitted to Braeburn for approval, such approval not to be unreasonably withheld, conditioned or delayed.

 

17

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

4.2                               Ownership.  Knight acknowledges that the Braeburn Marks and Sublicensed Product Trademarks are owned or licensed by Braeburn.  The Braeburn Marks and Sublicensed Product Trademarks shall be and remain the sole and exclusive property of Braeburn.  Knight shall not contest the ownership of the Braeburn Marks or the Sublicensed Product Trademarks or the validity of any registration relating thereto or assist any Third Party in doing so.  Knight agrees, at the request of Braeburn, to execute any and all proper and reasonable documents appropriate to assist Braeburn in obtaining and maintaining Braeburn’s rights in and to the Braeburn Marks and Sublicensed Product Trademarks.

 

4.3                               Sublicensed Products to Bear Mark.  All packaging materials, package inserts, labels, labeling, and marketing, sales, advertising and Promotional Materials relating to Sublicensed Products distributed by Knight under this Agreement shall bear the Braeburn Marks and Sublicensed Product Trademarks together with a notice that the such marks are used under license from Braeburn, subject to the approval of such labeling by appropriate Governmental Authorities. Knight shall submit to Braeburn, for prior approval, which shall not be unreasonably withheld, conditioned or delayed, all materials bearing the Braeburn Marks and/or Sublicensed Product Trademarks that Knight intends to use with respect to Sublicensed Products.

 

4.4                               Enforcement.  Braeburn and Knight shall cooperate with each other and use Commercially Reasonable Efforts to protect the Braeburn Marks and Sublicensed Product Trademarks from infringement by Third Parties.  Without limiting the foregoing, each Party shall promptly notify the other Party of any known, threatened or suspected infringement, imitation or unauthorized use of or unfair competition relating to the Braeburn Marks and Sublicensed Product Trademarks and shall share with the other Party all information available to it regarding such infringement.  Braeburn shall have the first right to determine in its discretion whether to and to what extent to institute, prosecute and/or defend any action or proceedings involving or affecting any rights relating to the Braeburn Marks and Sublicensed Product Trademarks in the Territory.  Upon Braeburn’s reasonable request, Knight shall cooperate with and assist Braeburn in any of Braeburn’s enforcement efforts with respect to the Braeburn Marks and Sublicensed Product Trademarks in the Territory. If Braeburn determines not to take action against any actual or suspected infringement of the Sublicensed Product Trademark in the Territory within [***] days after having become aware of such infringement, then Knight shall have the right, but not the obligation, to bring or assume control of any action against the allegedly infringing Third Party as Knight determines may be necessary in its sole discretion, to the extent permitted under the Titan Agreement.  In the event that Knight brings or assumes control of any such action, then Braeburn agrees to reasonably assist Knight in connection therewith.  [***].

 

4.5                               No Similar Mark.  Neither Knight nor any of its Affiliates or sublicensees will, without Braeburn’s prior written consent, register or use in connection with the Commercialization of any product other than a Sublicensed Product under the Braeburn

 

18

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Marks or the Sublicensed Product Trademarks or any trade-mark that is confusingly similar to the Braeburn Marks or the Sublicensed Product Trademarks.

 

5.                                      COMMERCIALIZATION

 

5.1                               General.

 

(a)                                 Subject to the terms and conditions of this Agreement, Knight shall during the Term use Commercially Reasonable Efforts to Commercialize and Promote the Sublicensed Products in the Territory following the Regulatory Approval in the Territory.

 

(b)                                 Without limiting the generality of the foregoing, and in accordance with the Commercialization Plan, Knight shall (i) Launch Sublicensed Product for the Initial Indication and each Subsequent Indication in the [***]; (ii) expend, in connection with such Launch of Sublicensed Product, such amounts as are commercially reasonable in connection with the marketing and Promotion of Sublicensed Products in the Territory, with the objective of maximizing the commercial potential and promoting the therapeutic profile and benefits of the Sublicensed Products; and (iii) devote marketing and sales resources and other personnel to such commercialization consistent with such Commercially Reasonable Efforts.

 

5.2                               Commercialization Plan and Promotional Materials and Activities.

 

(a)                                 Promotional Materials shall be subject to Braeburn’s approval, such approval not to be unreasonably withheld, conditioned or delayed.  Knight will prepare an initial Commercialization Plan, which will be provided to Braeburn no later than [***] days prior to estimated receipt of Regulatory Approval for the Sublicensed Product for the Initial Indication in the Territory, as mutually agreed by the Parties.  Knight shall also provide to Braeburn (i) updates of the Commercialization Plan at least [***] days prior to the estimated Launch of the Sublicensed Product for the Initial Indication and, if applicable, each Subsequent Indication, and thereafter on an annual basis or as necessary to reflect any significant amendments to the Commercialization Plan last provided to Braeburn under this Section 5.2(a), (ii) updated information regarding the expected and actual date of Launch for the Initial Indication and each Subsequent Indication, and (iii) any sales or tracking reports received by Knight from Third Parties with respect to the Sublicensed Products.  Notwithstanding anything to the contrary in this Agreement, Braeburn may share the Commercialization Plan and the foregoing information with Titan to the extent required by the Titan Agreement.

 

(b)                                 All Promotional Materials used by Knight will indicate that a Sublicensed Product is sold under license from Titan and Braeburn.  Knight shall limit its statements, discussions and claims regarding Sublicensed Products, including those as to

 

19

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

safety and efficacy, to those that are consistent with the Sublicensed Product Labeling and the Promotional Materials.  Knight shall not distort claims of safety or efficacy in the Promotion of the Sublicensed Products.

 

(c)                                  Knight shall be solely responsible for preparing all Regulatory Submissions with Regulatory Authorities in the Territory regarding approval of all Promotional Materials that require such approval.

 

(d)                                 Knight and its sublicensees and Third Party contractors shall be responsible for responding to medical questions or inquiries from members of the medical and paramedical professions and consumers in or relating to the Territory regarding Sublicensed Products, including the distribution of standard medical information letters resulting from the marketing activities of the Knight Sales Force.  The Knight Sales Force shall be trained using Braeburn’s training materials, except as otherwise required by Applicable Laws in the Territory.  Braeburn shall refer all medical inquiries that it receives related to the Territory to Knight.  Knight shall provide copies of the responses given, all in accordance with Applicable Laws, including regulations and policies of Health Canada or the applicable Regulatory Authority, to Braeburn.  Braeburn shall, at Knight’s request, from time to time, assist Knight with the formulation of responses to such inquiries, including the content of any frequently asked questions materials.  If mutually agreed by the Parties, the Parties shall establish a centralized database to document and track medical inquiries. Braeburn shall provide information and access to data, records and reports reasonably requested by Knight to fulfill its obligations under this Section 5.2(d).

 

(e)                                  Knight covenants that the Knight Sales Force shall (i) limit its claims of efficacy and safety for the Sublicensed Products in the Territory to those that are consistent with the prescribing information approved by the applicable Regulatory Authority for Sublicensed Products in the Territory; (ii) not add, delete or modify claims of efficacy and safety in the Promotion of Sublicensed Products under this Agreement from those claims of efficacy and safety that are consistent with the prescribing information approved by the applicable Regulatory Authority and with Applicable Law; (iii) use the Promotional Materials in accordance with this Section 5.3; and (iv) Promote Sublicensed Products under this Agreement in accordance with Applicable Laws, and in compliance with the then current industry standards concerning interactions with healthcare professionals.

 

5.3                               Safety Data Exchange Agreement.

 

(a)                                 The Parties agree to develop and commit to a SDEA that allows them to fulfill their respective regulatory and pharmacovigilance obligations relating to Adverse Experience reporting to Regulatory Authorities in accordance with Applicable Laws.  Such SDEA will be completed within [***] days after the Effective Date and prior to Launch.  Knight shall be responsible for the timely filing with the

 

20

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

applicable Regulatory Authority of all Adverse Experience reports in the Territory.  The SDEA shall provide for the exchange of safety information between the Parties sufficient to enable each Party to comply with its legal obligations to report to the applicable Regulatory Authority, for Braeburn to comply with the Titan Agreement, and include any measures necessary for each Party to comply with Applicable Laws.  Each Party shall promptly provide the other Party with copies of all such reports, analyses, summaries and all submissions to the applicable Regulatory Authority. The Adverse Experience procedures utilized in the preparation and filing of such reports will incorporate the provisions set forth in Section 5.3(b).

 

(b)                                 Prior to Launch, Knight will establish a system for the reporting of Adverse Experiences by patients, physicians and others that is customary for the Territory and that complies with all Applicable Laws.  [***].  Knight or a Third Party contractor will timely collect reasonable information about the Adverse Experiences, initiate and conduct reasonably required investigations, interact with Braeburn if physical or other testing of a Sublicensed Product appears to be reasonably required, determine the nature of the Adverse Experience based on data and reports it has obtained, and issue any reports, analyses or summaries of its activities as may be required by Applicable Laws.  Copies of such reports will be promptly provided to Braeburn.

 

(c)                                  All safety related reports and correspondence shall be addressed to such safety representative as may be designated by Braeburn and Knight.

 

5.4                               Quality Complaint Reporting.  Knight shall be solely responsible for collecting and responding to any product quality complaint relating to the Sublicensed Products received from a customer in or relating to the Territory and resulting from use in the Field.  Knight shall investigate and provide Braeburn, in a timely manner, with reports resulting from such investigations. If Braeburn receives a product quality complaint relating to the Sublicensed Products from a customer in or relating to the Territory resulting from use in the Field, it shall promptly notify Knight of such complaint, and Knight will investigate and promptly report the investigation results to Braeburn and be solely responsible for communication and response, if any, to any customer(s) in the Territory. Furthermore, Braeburn shall also be responsible for investigating and reporting the investigation results to Knight respecting any product quality complaints related to the manufacturing of the Sublicensed Products.

 

5.5                               Other Information.  In addition to the foregoing information to be provided, each Party shall provide to the other Party with any: (i) information relating to the efficacy and/or safety of the Sublicensed Products, including any Recall of the Sublicensed Products; (ii) complaints from customers, healthcare professionals or competitors in or relating to the Territory and relating to the Sublicensed Products; (iii) information relating to any potential liability to any Third Party in or relating to the Territory that is reasonably likely

 

21

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

to arise for either Party in connection with the manufacture, or Commercialization of the Sublicensed Products in or for the Territory; (iv) information relating to any inspections, inquiries, issues raised or actions taken by any Governmental Authority in or related to the Territory; and (v) any other information necessary or reasonably desirable to enable each Party to comply with any Applicable Laws in the Territory or elsewhere.

 

5.6                               Recall.  If any Regulatory Authority in the Territory issues or requests a recall, market withdrawal or other corrective action (a “Recall”) of a Sublicensed Product, or if either Party determines that an event, incident or circumstance has occurred that may indicate the need for a Recall in the Territory, the Party notified of such Recall, or the Party that desires such Recall, will advise the other Party thereof by telephone or fax within [***] of (i) its receipt of notice from a Regulatory Authority requiring or requesting a Recall or (ii) such Party’s determination that a Recall is indicated, and Braeburn and Knight shall convene a joint telephonic meeting to discuss such Recall request within [***] of such notification.  Knight shall include any reasonable recommendation from Braeburn as to the manner of conducting the Recall, provided that such recommendation is agreeable to the applicable Regulatory Authority and in accordance with the Applicable Laws.  Except as otherwise provided in the foregoing, Knight shall make all decisions with respect to the execution of any Recall related to a Sublicensed Product in the Territory, including communicating directly with the applicable Regulatory Authorities.  At Knight’s request, Braeburn shall provide, at its cost reasonable assistance in conducting any such Recall, including providing all pertinent records that Knight may reasonably request to assist in effecting such action.  Neither Party shall have any obligation to reimburse or otherwise compensate the other Party or its Affiliates for any consequential damages, lost profits or income that may arise in connection with any Recall with respect to the Sublicensed Products.

 

5.7                               NDA Transfer Date.  [***].

 

6.                                      PRICES AND PAYMENTS

 

6.1                               Royalties.  In consideration of the rights granted by Braeburn hereunder, during the Term, Knight will pay to Braeburn the following royalties (“Royalties”):

 

[***]

 

[***] following Launch, Braeburn is paying royalties to Titan under the Titan Agreement in the amount of [***] of net sales (as described in the Titan Agreement), then the Base royalty and the Tier 1 royalty shall be [***].  To the extent royalty rights are successfully renegotiated with Titan, Knight’s royalty rates shall remain as contemplated by (a) through (d) above.”

 

6.2                               Supply Price.  Knight will pay Braeburn under the Supply Agreement a supply price for each final packaged kit containing four Sublicensed Product implant rods and applicator in an amount equal to [***] (the “Supply Price”).  Nothing other than the final packaged

 

22

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

kit manufactured and/or supplied by Braeburn hereunder or under the Supply Agreement and included in the Supply Price is required by Knight to fully commercialize the Sublicensed Product in the Territory.  In the event Braeburn changes the format of the packaging or number of rods contained within each final packaged kit, the Supply Price will be recalculated to reflect an amount equal to [***].  In the event there are greater-than-anticipated cost increases for the manufacture of Sublicensed Products, Braeburn will be entitled to increase the Supply Price [***] (“Supply Price Increase”).

 

6.3                               Reports and Payments.

 

(a)                                 Within [***] calendar days after the end of each Calendar Quarter following Launch that begins or ends during the Term, Knight shall furnish to Braeburn a written report (each, a “Royalty Report”) showing:

 

(i)                                     all Net Sales during (A) such Calendar Quarter, [***], and (B) the Calendar Year to date through the end of such Calendar Quarter; and

 

(ii)                                  [***]; and

 

(iii)                               [***](a “Royalty True-Up”).

 

(b)                                 Each such Royalty Report shall be accompanied by payment of the Royalties due under Section 6.1, plus or minus any adjustment of Royalties previously paid, calculated in accordance with the immediately preceding clause (a)(iii) of this Section 6.3, as applicable.

 

(c)                                  Within [***] days after the Calendar Quarter during which this Agreement terminates or expires (the “Final Royalty Period”), Knight shall furnish to Braeburn a final Royalty True-Up with respect to such Calendar Quarter (the “Final Royalty True-Up Report”).  If the Final Royalty True-Up Report indicates that additional Royalties are payable with respect to the Final Royalty Period, such Final Royalty True-Up Report shall be accompanied by payment of such additional Royalties.  If the Final Royalty True-Up Report indicates that Royalties were overpaid with respect to the Final Royalty Period, Braeburn shall pay to Knight an amount equal to such overpayment within [***] days following the delivery of the Final Royalty True-Up to Braeburn.  If Braeburn disagrees with the Final Royalty True-Up Report, Braeburn shall notify Knight within [***] days after receipt thereof and such disagreement shall be resolved pursuant to Section 6.5 below.

 

(d)                                 Knight shall keep and shall require its Affiliates and its or their sublicensees to keep complete and accurate records in connection with the purchase, use and/or sale by or for it of Sublicensed Products hereunder in sufficient detail to permit accurate determination of all amounts necessary for calculation and verification of all payment obligations set forth in this Article 6.

 

23

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(e)                                  Without limiting any Party’s remedies hereunder, in the event payments required to be made under this Section 6.3 or any other provision of this Agreement are not made on or prior to the required payment date, the amount of the late payment shall bear interest [***], or the maximum rate allowable by Applicable Law, whichever is lower.

 

(f)                                   Except as otherwise defined herein, all financial calculations by either Party under this Agreement shall be calculated in accordance with its Accounting Standards.  All payments due by one Party to the other Party under this Agreement shall be payable in United States Dollars, except as otherwise set forth in this Agreement.  In addition, all calculations herein shall give pro-rata effect to and shall proportionally adjust (by giving effect to the number of applicable days in such Calendar Quarter) for any Calendar Quarter that is shorter than a standard Calendar Quarter or any Calendar Year (or twelve month period) that is shorter than four consecutive full Calendar Quarters or twelve consecutive months, as applicable.

 

6.4                               Record Retention.  Knight will maintain complete and accurate books, records, and accounts in sufficient detail to confirm the accuracy of any payments required under this Agreement and the Royalty Reports delivered under Section 6.3, which books, records, and accounts will be retained until [***] years after the end of the period to which such books, records, and accounts pertain.

 

6.5                               Audits.

 

(a)                                 Independent Audit.

 

(i)                                     During the Term and for [***] years thereafter, Braeburn, upon prior written notice to Knight and at a mutually agreeable time, but in no event more than once in any [***] month period, may request, and Knight shall permit, an independent certified public accounting firm of internationally recognized standing selected by Braeburn and reasonably acceptable to the Knight, to have access during normal business hours to the records of Knight as may be reasonably necessary to verify any payment made or due hereunder and the accuracy of the reports, including the Royalty Report; provided, however, that any audit conducted under this Section 6.5 may only be for any Calendar Year or Calendar Years (or any portion thereof) ending not more than [***] months prior to the date of such request. The accounting firm shall disclose to Braeburn only whether the payments and reports are correct or incorrect, the specific details concerning any discrepancies (including, if applicable, the accuracy of the calculation of Net Sales, and the resulting effect of such calculations on the amounts payable by Knight under this Agreement), but no other information shall be disclosed to Braeburn.

 

24

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(ii)                                  If there is a dispute between the Parties following any audit performed pursuant to Section 6.5(a)(i), either Party may refer the issue (an “Audit Disagreement”) to a second independent certified public accounting firm of internationally recognized standing (the “Independent Expert”) for resolution. In the event an Audit Disagreement is submitted for resolution by either Party, the Parties shall comply with the following procedures: [***].

 

(b)                                 If, pursuant to Section 6.5(a)(i) or 6.5(a)(ii), as applicable, an accounting firm concludes that additional amounts were owed during a Calendar Year, Knight shall pay the additional amounts plus interest as set forth in Section 6.3(e) above on the amount of such additional payments, within [***] calendar days of the date such accounting firm’s written report so concluding is delivered to Knight.  In the event such accounting firm concludes that amounts were overpaid by Knight during such period, Braeburn shall, to the extent such overpayment was known to Braeburn, repay Knight the amount of such overpayment plus interest as set forth in Section 6.3(e) above on the amount of such overpayment, within [***] days after the date such accounting firm’s written report so concluding is delivered to Braeburn, or, to the extent such overpayment was not known to Braeburn, Knight may reduce subsequent payment(s) to Braeburn under this Agreement by the amount of such overpayment.  The fees charged by such accounting firm(s) shall be paid [***].

 

(c)                                  Each Party shall treat all financial information subject to review under this Section 6.5 in accordance with the confidentiality provisions of Article 10.

 

6.6                               Payment Method.  All payments due to Braeburn hereunder will be paid in United States Dollars by wire transfer to an account designated by Braeburn.

 

7.                                      MANUFACTURE AND SUPPLY

 

7.1                               Manufacture and Supply by Braeburn.  During the Term, Knight agrees to obtain exclusively from Braeburn all Knight’s requirements of the Sublicensed Products for the Territory at the Supply Price and otherwise on the terms and subject to the conditions of a manufacturing and supply agreement in customary form for the pharmaceutical industry to be mutually agreed between the Parties following the Effective Date (the “Supply Agreement”); provided, that the Parties shall negotiate in good faith and use Commercially Reasonable Efforts to execute and deliver the Supply Agreement within [***].  Subject to the execution and delivery of the Supply Agreement, Braeburn agrees to supply Knight with all of its requirements of Sublicensed Products for Commercialization in the Territory during the Term.  For the avoidance of doubt, Braeburn may, at its discretion, use the services of a Third Party to manufacture and/or package some or all of the Sublicensed Products supplied to Knight under the Supply Agreement.

 

25

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

7.2                               Quality Agreement.  To the extent Braeburn manufactures Sublicensed Products supplied to Knight under the Supply Agreement, as required under Applicable Laws, or as reasonably requested by a Party, the Parties shall enter into a separate quality agreement in customary form for the pharmaceutical industry mutually agreed by the Parties regarding the supply, quality control and quality assurance of Sublicensed Products supplied to Knight under the Supply Agreement (the “Quality Agreement”).

 

7.3                               Conflicts.  Except as may be expressly set forth in the Supply Agreement or Quality Agreement, in the event of any conflict or inconsistency between the terms and conditions of the Supply Agreement or Quality Agreement, on the one hand, and this Agreement, on the other hand, the Supply Agreement or Quality Agreement, as applicable, shall govern and control with respect to all matters relating to the manufacturing, supply, quality control and quality assurance of or relating to the Sublicensed Products supplied to Knight under the Supply Agreement, and this Agreement shall govern and control with respect to all other matters.

 

8.                                      INTELLECTUAL PROPERTY

 

8.1                               Ownership.  As between the Parties, Braeburn shall have and retain all right, title and interest in or Control over, as applicable, all Braeburn Patents, inventions, discoveries, and Braeburn Know-How concerning Sublicensed Products, including formulations thereof, or methods of making or using same which have been made, conceived, reduced to practice or generated by its employees, agents, or other persons acting under its authority prior to the Effective Date.  As between the Parties, during the Term, except as otherwise provided in and subject to the terms and conditions of this Agreement, Braeburn shall have and retain all rights, title and interest in all inventions, discoveries and know-how relating to Sublicensed Products, including formulations thereof, or methods of making or using same, or Improvements thereof (collectively, “Inventions”), that are made, conceived, reduced to practice or generated, whether solely or jointly, by Braeburn’s employees, agents, or other persons acting under its authority and/or by Knight’s employees or agents, or, to the extent Knight becomes aware of any such Inventions, by other persons acting under its authority.  Knight shall notify Braeburn promptly of any Inventions that are made, conceived, reduced to practice or generated solely by Knight’s employees, agents, or other persons acting under its authority.  To the extent required by Applicable Law, Knight shall assign or otherwise transfer all rights, title and interest in any of the foregoing Inventions to Braeburn, and Knight agrees, at the request of Braeburn, to execute any and all proper documents appropriate to assist Braeburn in obtaining and maintaining Braeburn’s rights in and to the foregoing Inventions.

 

8.2                               Patent Prosecution.  Braeburn shall have the first right to prosecute and maintain the Braeburn Patents and any patent application(s) or patent(s) arising from this Agreement, using patent counsel selected by Braeburn, and shall be responsible for the payment of all prosecution and maintenance costs. Braeburn shall not abandon prosecution or

 

26

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

maintenance of any or all patents or patent applications directly related to the Sublicensed Products in the Territory without notifying Knight in a timely manner of Braeburn’s intention and reason therefore and providing Knight with reasonable opportunity to comment upon such abandonment and to assume responsibility for prosecution or maintenance of such Patent Rights.  To the extent allowed under the Titan Agreement, in the event that Braeburn abandons prosecution or maintenance of any or all patents or patent applications directly related to the Sublicensed Products in the Territory, Knight may assume prosecution and filing responsibility for such Patent Rights in the Territory, at its sole expense, and thereafter such patent rights will be owned solely and exclusively by Knight.

 

8.3                               Notification of Third Party Infringement.  Each Party shall promptly disclose to the other in writing, and share within [***] Business Days all available information known to the Party in connection with any actual, suspected, alleged, or threatened infringement or misappropriation of any Braeburn Patent, or any actual, suspected, alleged or threatened infringement or passing off of the Braeburn Mark, in the Territory, of which such Party becomes aware.  The Parties will thereafter consult and cooperate to determine a course of action, including the commencement of legal action by any Party.

 

8.4                               Response to Third Party Infringement.

 

(a)                                 Braeburn shall have the first right, but not any obligation, to initiate and respond to any actual or threatened infringement of a Braeburn Patent, the Braeburn Mark or of any unfair trade practices, trade dress imitation, passing off of counterfeit goods, or like offenses in the Territory relating to the Sublicensed Products.  If Braeburn elects to respond to any actual or threatened infringement by initiating a proceeding, Braeburn shall use legal counsel of its choice at its expense and shall have full control over the conduct of such proceeding, including whether to initiate any legal proceeding and/or the settlement thereof.  Braeburn may settle or compromise any such proceeding without the consent of Knight; provided, however, that if such settlement adversely affects Knight’s rights under this Agreement, or Knight’s ability to Commercialize the Sublicensed Products within the Territory, or otherwise requires Knight to admit wrongdoing, fault, or liability, Braeburn will not settle or compromise any such proceeding without the consent of Knight, such consent not to be unreasonably withheld, conditioned or delayed.

 

(b)                                 If, within a period of [***] days after the first notice of infringement is provided under Section 8.4, Braeburn elects not to initiate and respond to any actual or threatened infringement of a Braeburn Patent, a Braeburn Mark or of any unfair trade practices, trade dress imitation, passing off of counterfeit goods, or like offenses in the Territory relating to the Sublicensed Products, then Knight shall have the right, but not the obligation, to take action, at its sole expense and to the extent permitted under the Titan Agreement, in which case Knight shall have full control over the conduct of such proceeding and Knight may settle or compromise

 

27

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

any such proceeding without the consent of Braeburn; provided, however, that if such settlement adversely affects Braeburn’s intellectual property rights or its rights under this Agreement, or Braeburn’s ability to Commercialize the Sublicensed Products outside the Territory, results in any monetary payment by or financial loss to Braeburn or otherwise requires Braeburn to admit wrongdoing, fault, or liability, Knight will not settle or compromise any such proceeding without the consent of Braeburn, such consent not to be unreasonably withheld, conditioned or delayed.  Knight shall be solely responsible for any legal costs or damages awards made in any proceeding that is initiated by Knight in the event that Braeburn elects not to respond to any actual or threatened infringement.

 

8.5                               Cooperation.  Each Party shall cooperate reasonably, at its expense, in any enforcement effort initiated by the other Party. The Parties nor their Affiliates shall contest any joinder in any proceeding sought to be brought by the other Party if such joinder is required by Applicable Law.  For any legal action or defense described in Section 8.4 above, in the event that any Party is unable to initiate, prosecute or defend such action solely in its own name, the other Party will join such action voluntarily and will execute all documents necessary for the Party to defend, prosecute and maintain such action.  In connection with any such action, the Parties will cooperate fully and will provide each other with any information or assistance that either reasonably may request.

 

8.6                               Recovery.  Except as otherwise agreed to by the Parties as part of a cost-sharing arrangement, any monetary award recovered from a Third Party in connection with any proceeding described in Section 8.4 above shall be [***]:

 

[***]

 

8.7                               Infringement of Third Party IP.

 

(a)                                 If either Party becomes aware that its activities performed hereunder may constitute actual or alleged infringement or misappropriation of the intellectual property rights of a Third Party in the Territory, it shall promptly notify the other Party and the Parties shall discuss a strategy to defend or mitigate against any actual or alleged infringement.

 

(b)                                 Braeburn shall have the first right, but not the obligation, to defend any action in the Territory related to the intellectual property rights of any Third Party or to initiate and prosecute legal action related to the intellectual property rights of any Third Party at its own expense and in the name of Braeburn and/or Knight.  Knight shall render, at its expense, all assistance reasonably requested in connection with any action taken by Braeburn. However, the control of such action, including whether to initiate any legal proceeding and/or the settlement thereof, shall solely be under the control of Braeburn; provided, however, that if such settlement adversely affects Knight’s rights under this Agreement, or Knight’s ability to Commercialize the Sublicensed Products within the Territory,

 

28

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

or otherwise requires Knight to admit wrongdoing, fault, or liability, Braeburn will not settle or compromise any such proceeding without the consent of Knight, such consent not to be unreasonably withheld, conditioned or delayed.

 

(c)                                  If Braeburn elects not to defend an infringement action in the Territory as provided in Section 8.4(b), and Knight elects to do so, the cost of any agreed-upon course of action, including the costs of any legal action commenced or any infringement action defended, shall be borne solely by Knight; provided, however, that if such settlement adversely affects Braeburn’s intellectual property rights or its rights under this Agreement, or Braeburn’s ability to Commercialize the Sublicensed Products outside the Territory, results in any monetary payment by or financial loss to Braeburn or otherwise requires Braeburn to admit wrongdoing, fault, or liability, Knight will not settle or compromise any such proceeding without the consent of Braeburn, such consent not to be unreasonably withheld, conditioned or delayed.

 

(d)                                 For any such legal action or defense, in the event that any Party is unable to initiate, prosecute, or defend such action solely in its own name, the other Party will join such action voluntarily and will execute all documents necessary for the Party to prosecute, defend and maintain such action.  In connection with any such action, the Parties will cooperate fully and will provide each other with any information or assistance that either reasonably may request.

 

9.                                      REPRESENTATION AND WARRANTIES

 

9.1                               Braeburn Covenants, Representations and Warranties.  Braeburn covenants, represents and warrants (as the case may be) to Knight as of the Effective Date that:

 

(a)                                 Braeburn is a corporation duly organized, validly existing and in good standing under the laws of Delaware.

 

(b)                                 Braeburn has the corporate power and authority to enter into this Agreement and will continue during the Term to have, all of the corporate power and authority necessary to enter into this Agreement and to grant the licenses hereunder.

 

(c)                                  Braeburn has taken all necessary corporate actions to authorize the execution, delivery and performance of this Agreement.

 

(d)                                 The Titan Agreement (i) is in full force and effect, enforceable in accordance with its terms, except to the extent enforceability is limited by bankruptcy, insolvency or similar laws affecting creditors’ rights and remedies or equitable principles, and (ii) has not been terminated; and Braeburn has not taken any action to terminate the Titan Agreement.

 

29

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(e)                                  Braeburn shall provide Knight with (i) written notice within [***] Business Days of any alleged material breach of the Titan Agreement or written (including by email) threat of termination of the Titan Agreement received by Braeburn from Titan thereunder, and (ii) written notice within [***] Business Days of the adoption of any amendment to the Titan Agreement relating to the Territory or Knight’s rights under this Agreement, in each case, in any material respect.

 

(f)                                   Braeburn has obtained all consents, licenses and authorizations that are necessary to perform its obligations under this Agreement and that such rights will continue to be enforceable during the Term, except to the extent enforceability is limited by bankruptcy, insolvency or similar laws affecting creditors’ rights and remedies or equitable principles.

 

(g)                                  Upon the execution and delivery of this Agreement, this Agreement shall constitute a valid and binding obligation of Braeburn, enforceable against Braeburn in accordance with its terms, except to the extent enforceability is limited by bankruptcy, insolvency or similar laws affecting creditors’ rights and remedies or equitable principles.

 

(h)                                 The performance of Braeburn’s obligations under this Agreement will not conflict with its organizational documents, as amended, or result in a breach of any material agreements or contracts to which it is a party.

 

(i)                                     Braeburn has not and will not, during the term of this Agreement, enter into any material agreements or contracts that would conflict with its obligations under this Agreement and Braeburn has no knowledge of any agreement entered into by Titan which would conflict or restrict the terms hereof;

 

(j)                                    Braeburn owns or licenses all of the Braeburn Patents licensed to Knight pursuant to this Agreement and the Braeburn Patents licensed or sublicensed to Knight pursuant to this Agreement are all of the patents owned or licensed by Braeburn that are reasonably necessary for Knight to carry out its obligations and exercise its rights under this Agreement.

 

(k)                                 Braeburn has not received any notice that the manufacture, sale or use of the Sublicensed Products in the Territory infringes upon any intellectual property rights of any Third Party(ies) in the Territory.

 

(l)                                     Braeburn has not received any notice from a Third Party that any issued Braeburn Patent is invalid or unenforceable for any reason.

 

(m)                             To the knowledge of Braeburn, there are no activities being carried out by Third Parties in the Territory that would constitute infringement or misappropriation of the Braeburn Patents or the Braeburn Marks.

 

30

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(n)                                 Braeburn shall use its Commercially Reasonable Efforts to maintain the Titan Agreement in full force and effect throughout the Term; provided, however, that the Parties agree and acknowledge that it may be commercially reasonable for Braeburn to terminate the Titan Agreement or take actions that result in the termination of the Titan Agreement and provided further that for avoidance of doubt, this Section does not provide Braeburn with any termination right not contemplated by Section 11.2 hereof.

 

(o)                                 Braeburn has provided Knight all material information in its possession and Control sufficient for Knight to assess the safety and efficacy of the Sublicensed Product, and any side effects, injury, toxicity or sensitivity reactions and incidents associated with all uses, studies, investigations or tests involving the Sublicensed Product (animal or human) throughout the world;

 

(p)                                 As of the Effective Date, Braeburn is not aware of any material facts not otherwise disclosed to Knight that could reasonably lead Braeburn to conclude that the Sublicensed Product will be unable to receive Regulatory Approval from relevant Governmental Authorities in the Territory.

 

(q)                                 Neither Braeburn nor, to the knowledge of Braeburn, any Third Party acting by or on behalf of Braeburn in connection with the manufacture, development or Commercialization of the Sublicensed Products has been debarred or is subject to debarment, and Braeburn shall not knowingly engage or use any Third Party in connection with the manufacture, development or Commercialization of the Sublicensed Products that has been debarred; Braeburn agrees to notify Knight in writing promptly if it, or if it has knowledge that, any of its licensors or any entity acting on its behalf in any capacity in connection with the manufacture, development or Commercialization of the Sublicensed Products is debarred or becomes the subject of any threatened or pending action, suit, claim, investigation, legal or administrative proceeding relating to debarment.

 

9.2                               Knight Covenants, Representations and Warranties.  Knight covenants, represents and warrants to Braeburn (as the case may be) as follows:

 

(a)                                 Knight is a corporation duly organized, validly existing and in good standing, under the laws of Canada.

 

(b)                                 Knight has the legal right, authority, and power to enter into this Agreement and will continue during the Term to have, all of the rights necessary to enter into this Agreement and to perform its obligations hereunder.

 

(c)                                  Knight has taken all necessary action to authorize the execution, delivery, and performance of this Agreement.

 

31

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(d)                                 Without limiting Knight’s obligations to use Commercially Reasonable Efforts to Commercialize the Sublicensed Products under this Agreement, Knight will seek to obtain and, once obtained, maintain all consents, licenses and authorizations that are necessary to perform its obligations under this Agreement.

 

(e)                                  Upon the execution and delivery of this Agreement, this Agreement shall constitute a valid and binding obligation of Knight, enforceable against Knight in accordance with its terms, except to the extent enforceability is limited by bankruptcy, insolvency or similar laws affecting creditors’ rights and remedies or equitable principles.

 

(f)                                   The performance of Knight’s obligations under this Agreement will not conflict with its organizational documents, as amended, or result in a breach of any material agreements or contracts to which any is a party.

 

(g)                                  Knight has not and will not, during the term of this Agreement, enter into any material agreements or contracts that would be inconsistent with its obligations under this Agreement.

 

(h)                                 Neither Knight nor its Affiliates and sublicensees will initiate a proceeding to challenge the validity or enforceability of any Braeburn Patent or Braeburn Mark, or directly or indirectly assist any Third Party with respect to any such proceeding.

 

(i)                                     [***].

 

(j)                                    Neither Knight nor, to the knowledge of Knight, any Third Party acting by or on behalf of Knight in connection with the manufacture, development or Commercialization of the Sublicensed Products has been debarred or is subject to debarment, and Knight shall not knowingly engage or use any Third Party in connection with the manufacture, development or Commercialization of the Sublicensed Products that has been debarred; Knight agrees to notify Braeburn in writing promptly if it, or if it has knowledge that, any of its licensors or any entity acting on its behalf in any capacity in connection with the manufacture, development or Commercialization of the Sublicensed Products is debarred or becomes the subject of any threatened or pending action, suit, claim, investigation, legal or administrative proceeding relating to debarment.

 

(k)                                 Neither Knight nor, to the knowledge of Knight, any of its equity holders nor any of their respective beneficial owners (a) is listed on any Government Lists (as defined below), (b) is a person who has been determined by competent authority to be subject to the prohibitions contained in Presidential Executive Order No. 13224 (Sept. 23, 2001) or any other similar prohibitions contained in the rules and regulations of the Office of Foreign Assets Control (“OFAC”) or in any enabling legislation or other Presidential Executive Order in respect thereof, (c) has been

 

32

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

previously indicted for or convicted of any Patriot Act Offense (as defined below), or (d) is currently under investigation by any governmental authority for alleged criminal activity in connection with any Patriot Act Offense.  For purposes hereof, the term “Patriot Act Offense” means (i) any violation of the criminal laws of the United States of America, or that would be a criminal violation if committed within the jurisdiction of the United States of America, relating to terrorism or the laundering of monetary instruments, including any offense under (A) the criminal laws against terrorism, (B) the criminal laws against money laundering, (C) the Bank Secrecy Act, (D) the Money Laundering Control Act of 1986, or (E) the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT ACT) Act of 2001; and (ii) the crime of conspiracy to commit, or aiding and abetting another to commit, a Patriot Act Offense under clause (i).  For purposes hereof, the term “Government Lists” means (x) the Specially Designated Nationals and Blocked Persons Lists maintained by the OFAC, (y) any other list of terrorists, terrorist organizations, or narcotics traffickers maintained pursuant to any of the Rules and Regulations of OFAC that is now included in “Government Lists,” or (z) any similar lists maintained by the United States Department of State, the United States Department of Commerce, or any other government authority or pursuant to any Executive Order of the President of the United States of America that is now included in Government Lists.

 

9.3                               WARRANTY DISCLAIMER.  EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, INCLUDING ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE LICENSED PRODUCTS OR ANY TECHNOLOGY OR ANY LICENSE GRANTED BY EITHER PARTY HEREUNDER, EVEN IF EITHER PARTY HAS BEEN ADVISED OF SUCH PURPOSE.

 

9.4                               LIMITATIONS OF LIABILITY.  EXCEPT IN CIRCUMSTANCES OF GROSS NEGLIGENCE OR WILLFUL MISCONDUCT BY A PARTY, A BREACH OF ARTICLE 10, FOR THE PAYMENT OF AN INDEMNIFIED CLAIM UNDER SECTIONS 9.5 OR 9.6 BELOW (BUT ONLY TO THE EXTENT OF SUCH CLAIM), NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR TO ANY THIRD PARTY WHO MAY BENEFIT FROM ANY PROVISION OF THIS AGREEMENT FOR SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES (INCLUDING DAMAGES RESULTING FROM LOSS OF USE, LOSS OF PROFITS, INTERRUPTION OR LOSS OF BUSINESS OR OTHER ECONOMIC LOSS) ARISING OUT OF THIS AGREEMENT OR WITH RESPECT TO A PARTY’S PERFORMANCE OR NON-PERFORMANCE HEREUNDER.

 

33

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

9.5                               Indemnification by Braeburn.  Braeburn hereby agrees to defend, indemnify, and hold Knight, [***].

 

9.6                               Indemnification by Knight.  Knight hereby agrees to defend, indemnify, and hold Braeburn, [***].

 

9.7                               Indemnification Procedure.  [***]

 

9.8                               Compliance with Applicable Law.  Each Party shall comply, and shall require their Affiliates and permitted sublicensees to comply, with all Applicable Laws relative to their obligations hereunder.

 

9.9                               Insurance.

 

(a)                                 Both Knight and Braeburn shall maintain, during the Term and for a period of [***] years after any expiration or termination of this Agreement, a Commercial General Liability Insurance policy or policies [***]

 

(b)                                 During the Term, [***].  Upon request, Knight shall provide certificates of insurance to Braeburn evidencing the coverage specified herein.  The Parties acknowledge and agree that such insurance shall not be construed to create a limit with respect to their indemnification obligations or liability to the other.

 

10.                               CONFIDENTIALITY AND PUBLICITY

 

10.1                        Non-Disclosure and Non-Use Obligations.  All Confidential Information disclosed by one Party to the other Party hereunder shall be maintained in confidence and shall not be disclosed to any Third Party or used for any purpose except as expressly permitted herein without the prior written consent of the Party that disclosed the Confidential Information to the other Party during the Term and for a period of [***] years thereafter.  For purposes of this Agreement, “Confidential Information” means any and all Know-How, scientific, clinical, regulatory, marketing, financial, technical, non-technical, commercial or other confidential information or data of a confidential nature, whether communicated in writing, orally or by any other means, that is under the protection of one Party and is provided by that Party to the other Party in connection with this Agreement.  The foregoing non-disclosure and non-use obligations shall not apply to the extent that such Proprietary Information:

 

(a)                                 is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by business records;

 

(b)                                 is or becomes properly in the public domain or knowledge without breach by either Party;

 

34

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(c)                                  is subsequently disclosed to a receiving Party by a Third Party who, to the knowledge of the receiving Party, is lawfully able do so and, to the knowledge of the receiving Party, is not under an obligation of confidentiality to the disclosing Party; or

 

(d)                                 is developed by the receiving Party independently of Confidential Information received from the other Party, as documented by research and development records.

 

10.2                        Permitted Disclosure of Proprietary Information.  Notwithstanding Section 10.1, a Party receiving Confidential Information of another Party may disclose such Confidential Information:

 

(a)                                 to governmental or other regulatory agencies as required by Applicable Law, in order to file Regulatory Submissions, but such disclosure may be made only to the extent reasonably necessary to file such Regulatory Submissions and in accordance with the terms and conditions of this Agreement or as otherwise requested by the relevant Governmental Authority;

 

(b)                                 in connection with the performance of this Agreement and solely on a need-to-know basis, to Affiliates; potential or actual collaborators (including potential sublicensees); potential or actual investment bankers, accountants, investors, lenders, or acquirers; or employees, independent contractors (including consultants and clinical investigators) or agents, each of whom prior to disclosure must be bound by written obligations of confidentiality and non-use no less restrictive than the obligations set forth in this Article 10 or to counsel for such Party; provided, however, that the receiving Party shall (i) undertake reasonable precautions to safeguard and protect the confidentiality of the Confidential Information; (ii) remain responsible for any failure by any person who receives Confidential Information pursuant to this Article 10 to treat such Confidential Information as required under this Article 10; and (iii) take all reasonable measures to restrain the receiving Party and any such persons from prohibited or unauthorized disclosure or use in violation of this Article 10;

 

(c)                                  if required to be disclosed by Applicable Law or court order, provided that notice is promptly delivered to the non-disclosing Party in order to provide an opportunity to challenge or limit the disclosure obligations; or

 

(d)                                 with respect to Braeburn, to Titan to the extent required by Braeburn to exercise its rights or perform its obligations under the Titan Agreement.

 

If and whenever any Confidential Information is disclosed in accordance with this Section 10.2, such 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 in breach of this Agreement). Where

 

35

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

reasonably possible and subject to Section 10.3, the receiving Party shall notify the disclosing Party of the receiving Party’s intent to make such disclosure pursuant to Sections 10.2(a)-(c) sufficiently prior to making such disclosure so as to allow the disclosing Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information, and the receiving Party shall cooperate with the disclosing Party in such efforts.

 

10.3                        Disclosure of Agreement to Governmental Authority.  Without limiting any of the foregoing, it is understood that the Parties or their Affiliates may make disclosure of this Agreement and the terms hereof in any filings required by a Governmental Authority or securities exchange, may file this Agreement as an exhibit to any filing with such Governmental Authority or securities exchange, and may distribute any such filing in the ordinary course of its business; provided however, that the Party seeking such disclosure first provides the other Party a copy of the proposed disclosure, and provided further that (except to the extent that the Party seeking disclosure is required to disclose such information to comply with Applicable Law) if the other Party demonstrates to the reasonable satisfaction of the Party seeking disclosure, within [***] Business Days of such Party’s providing the copy, that the public disclosure of previously undisclosed information will materially adversely affect the development and/or commercialization of a Sublicensed Product, the Party seeking disclosure will remove from the disclosure such specific previously undisclosed information as the other Party shall reasonably request to be removed, or otherwise provide a good faith reason to the other Party why such disclosure was not removed.

 

10.4                        Other Public Statements.  Except as set forth in this Agreement or as required by Applicable Law, neither Party shall make any press release or other public announcement or other disclosure to a Third Party concerning the existence or terms of this Agreement or relating to Sublicensed Products without the prior written consent of the other Party, which consent shall include agreement upon the nature and text of such announcement or disclosure and shall not be unreasonably withheld, conditioned or delayed.  Each Party agrees to provide to the other Party a copy of any public announcement as soon as reasonably practicable under the circumstances prior to its scheduled release.  Each Party shall have the right to expeditiously [***] review and recommend changes to any press release or announcement regarding this Agreement or the subject matter of this Agreement; provided, however that such right of review and recommendation shall only apply for the first time that specific information is to be disclosed, and shall not apply to the subsequent disclosure of substantially similar information that has previously been disclosed unless there have been material developments relating to Sublicensed Products since the date of the previous disclosure.

 

10.5                        No Rights to Use Name of Other Party.  Except as provided herein, neither Party shall use the name, trademark, trade name or logo of the other Party in any publicity, promotion, news release or disclosure relating to this Agreement or its subject matter,

 

36

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

without the prior express written permission of the other Party, except as may be required by Applicable Law.

 

11.                               TERM AND TERMINATION

 

11.1                        Term.  Except as expressly provided in Section 2.1, and unless earlier terminated pursuant to Section 11.2(a), this Agreement will take effect on the Effective Date and, unless earlier terminated in accordance with the terms herein, will continue in full force and effect for fifteen (15) years from the date of Launch of the Initial Indication (from the Effective Date until the fifteenth (15th) anniversary of the date of Launch of the Initial Indication, unless earlier terminated, the “Initial Term”); provided, that if a Subsequent Indication for the Sublicensed Product received Regulatory Approval in the Territory on or after the fifth (5th) anniversary of the Launch of the Initial Indication, the Parties shall negotiate in good faith with respect to an appropriate extension of the Initial Term.  Any such extension shall be mutually agreed in writing.  Upon the expiration of the Initial Term and any subsequent Term thereafter, this Agreement shall automatically renew for successive two (2) year periods (each a “Renewal Term”) unless, at least one hundred eighty (180) days prior to the scheduled expiry of the Initial Term or Renewal Term, either Party provides the other with written notice of its intention not to renew the Agreement (a “Non-Renewal Notice”), in which case this Agreement shall expire at the end of the applicable period.

 

11.2                        Early Termination.  This Agreement may be terminated as follows:

 

(a)                                 If the NDA Transfer Date has not occurred within six (6) months of the Effective Date, either Party may provide written notice of an intent to terminate this Agreement, provided that if a Party intends to terminate the Agreement, such Party shall first discuss in good faith the reasons for seeking termination and considers potential alternatives to termination, including potential amendments to the Agreement.  Termination under this Section 11.2(a) shall not effective be sooner than thirty (30) days from the date of notice.

 

(b)                                 Either Party may, without prejudice to any other remedies available to it under this Agreement or at Applicable Law or in equity:

 

(i)                                     immediately terminate this Agreement upon the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings, or upon an assignment of a substantial portion of the assets for the benefit of creditors by the other Party; provided, however, in the case of any involuntary bankruptcy, reorganization, liquidation, receivership or assignment proceeding such right to terminate shall only become effective if such other Party consents to the involuntary proceeding or such proceeding is not dismissed within sixty (60) days after the filing thereof; or

 

37

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(ii)                                  terminate this Agreement prior to expiration of the Term in the event the other Party is in material default or breach of the performance of its obligations hereunder, and has not cured such breach within (i) thirty (30) days after written notice thereof provided by the non-breaching Party to the breaching Party, in case such breach is a non-payment of any amount due under this Agreement (which shall be deemed a material breach) and (ii) sixty (60) days after written notice thereof provided by the non-breaching Party to the breaching Party for other cases of breach.  The termination shall become effective at the end of the (x) thirty (30) day period in case the breach is a non-payment of any amount due under this Agreement if the breaching Party has not cured such breach during such thirty (30) day period, or (y) sixty (60) day period for other cases of breach unless the breaching Party cures such breach during such sixty (60) day period.  The right of either Braeburn or Knight to terminate this Agreement as provided in this Section 11.2 shall not be affected in any way by such Party’s waiver or failure to take action with respect to any previous breach or default.

 

(c)                                  Braeburn may, without prejudice to any other remedies available to it under this Agreement or at Applicable Law or in equity, terminate this Agreement:

 

(i)                                     on thirty (30) days written notice to Knight, if Knight, following Launch, discontinues commercial sale of Sublicensed Product for a period of three (3) months or more for reasons unrelated to Force Majeure, regulatory or safety issues or supply or manufacturing or Sublicensed Product quality issues and subsequently fails to resume sales of a Product within thirty (30) days of having been notified in writing of such failure by Braeburn;

 

(ii)                                  upon written notice to Knight in the event Knight or any of its Affiliates or sublicensees commences any legal proceeding seeking to challenge or otherwise dispute the validity or ownership of any of the Braeburn Patents or any of the claims therein, or knowingly assists any Third Party to do any of the foregoing, which termination shall be effective on the date set forth in such notice; or

 

(iii)                               If Braeburn determines, in its sole discretion, that it is in its best interests to terminate the Titan Agreement pursuant to any one of Sections 12.2(c)(i), 12.2(c)(iii), and 12.2(c)(iv) of the Titan Agreement, then Braeburn shall provide Knight with at least ninety (90) days’ prior notice and, during such ninety-day (90-day) period, Braeburn shall discuss with Knight, in good faith, whether the grounds upon which Braeburn judges termination to be in its best interests can be adequately mitigated.  If, after discussions with Knight, Braeburn still decides it is in Braeburn’s best interests to terminate the Titan Agreement, then Braeburn shall negotiate

 

38

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

in good faith with Titan and Knight to determine whether Titan would agree to license rights in the Territory directly to Knight, including a commitment to supply Sublicensed Products to Knight.  Notwithstanding the foregoing, Braeburn may not terminate this Agreement under this Section 11.2(c)(iii) prior to three (3) years following the NDA Transfer date and then only upon at least one (1) year prior notice.  If Braeburn terminates the Titan agreement pursuant to this Section 11.2(c)(iii), then, notwithstanding the termination of this Agreement, the ROFN outlined in Section 2.9 shall survive for the remainder of the Initial Term.

 

(d)                                 Either Party may, without prejudice to any other remedies available to it under this Agreement or at Applicable Law or in equity, terminate this Agreement immediately upon written notice to the other Party, if either Party determines in good faith that it is not advisable for Knight to continue to Commercialize any Sublicensed Products in the Territory as a result of a bona fide safety issue regarding any Sublicensed Products.

 

(e)                                  This Agreement shall automatically terminate in the event the Titan Agreement is terminated prior to the expiration of the Term; provided that Braeburn shall not seek to terminate the Titan Agreement for any reason other than what is contemplated in Section 11.2(c) hereof, or Section 12.2(a) of the Titan Agreement.

 

11.3                        Effect of Termination.  Upon expiry or termination of this Agreement, all sublicenses and rights granted by Braeburn hereunder shall terminate and:

 

(a)                                 Knight undertakes to:

 

(i)                                     except as provided for in Section 11.5, cease any Commercialization of Sublicensed Products in the Territory;

 

(ii)                                  commence, within thirty (30) days of expiry or termination, and complete as promptly as practicable, the transfer of title to all current and pending Regulatory Submissions and Regulatory Approvals for the Sublicensed Products to Braeburn or its designee and assist Braeburn in submitting appropriate documents to transfer the Regulatory Submissions and Regulatory Approvals for the Sublicensed Products to Braeburn or its designee;

 

(iii)                               pay Braeburn all Royalties generated by sales of Sublicensed Products, including any sales in accordance with Section 11.5; and

 

(iv)                              promptly transfer to Braeburn or its designee copies of all data, reports, records and materials in Knight’s possession or Control that relate to Sublicensed Products and return to Braeburn all relevant records and

 

39

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

materials in Knight’s possession or Control containing Confidential Information of Braeburn (provided that Knight may keep (a) one (1) copy of such Confidential Information of Braeburn for archival purposes solely for the purpose of compliance with this Agreement and (b) electronic copies stored in automatic computer back-up systems ).

 

(b)                                 Braeburn undertakes to promptly return to Knight all relevant records and materials in Braeburn’s possession or Control containing Confidential Information of Knight (provided that Braeburn may keep one (1) copy of such Confidential Information of Knight for archival purposes solely for the purpose of compliance with this Agreement).

 

11.4                        Survival.  In the event of the expiration or termination of this Agreement for any reason, the following provisions of this Agreement shall survive: Article 1; Sections 6.3(c); 6.4; 6.5; 8.1; 9.3 through 9.9; Articles 10 through 13; and any other terms which, by their nature, require or contemplate performance by the Parties after expiry or termination.  In any event, expiration or termination of this Agreement shall not relieve the Parties of any liability which accrued hereunder prior to the effective date of such expiration or termination.

 

11.5                        Sell-Off of Inventory.  Subject to the payment of all amounts due to Braeburn hereunder, upon expiration or termination of this Agreement, Knight shall be entitled to sell off or otherwise dispose of any of Knight’s inventory of Sublicensed Products existing on the date such expiration or termination is effective; provided, however, that, at Braeburn’s request, Knight shall promptly return to Braeburn all or any portion of such inventory of Sublicensed Products that has not been sold or used within [***] months following such expiration or termination and Braeburn shall reimburse Knight any Supply Price previously paid by Knight for such Sublicensed Products that are returned to Braeburn

 

12.                               DISPUTE RESOLUTION

 

12.1                        Arbitration.  Except as otherwise expressly provided herein, any dispute or claim arising out of or relating to this Agreement, or to the breach, termination, or validity of this Agreement, will be resolved as follows: each Party shall discuss the matter and make reasonable efforts to attempt to resolve the dispute.  If the Parties are unable to resolve the dispute, the chief executive officer of each Party, or their designees, will meet within [***] days of a request to attempt to resolve such dispute being made by a Party.  If the chief executive officers, or their designees, cannot resolve the dispute through good faith negotiations within [***] days after a Party requests such meeting, then the Parties shall resort to binding arbitration before a single arbitrator, in New York, New York, using the arbitration procedures set forth under the laws of the State of New York.  The decision of the arbitrator shall be final and not subject to appeal and the arbitrator may apportion the costs of the arbitration, including the reasonable fees and disbursements of the Parties, between or among the Parties in such manner as the arbitrator considers reasonable.  All matters in relation to the arbitration shall be kept confidential to the full extent permitted

 

40

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

by law, and no individual shall be appointed as an arbitrator unless he or she agrees in writing to be bound by this provision.

 

12.2                        Irreparable Harm.  Notwithstanding anything to the contrary in Section 12.1, if either Party in its sole judgment, acting reasonably, believes that any such dispute could cause it irreparable harm, such Party will be entitled to seek temporary equitable relief from a court of competent jurisdiction in order to avoid such irreparable harm during the pendency of the procedure set forth in Section 12.1.  For the avoidance of any doubt, nothing in this Article 12 shall preclude, interfere with or modify either Party’s rights under Article 11 above with respect to the termination of this Agreement.

 

13.                               OTHER PROVISIONS

 

13.1                        Withholding Tax.  Knight will make all payments to Braeburn under this Agreement without deduction or withholding for taxes except to the extent that any such deduction or withholding is required by Applicable Law in effect at the time of payment.  Any tax required to be withheld on amounts payable by Knight under this Agreement will be timely paid by Knight on behalf of Braeburn to the appropriate Governmental Authority, and Knight will furnish Braeburn with the corresponding proof of payment of such tax, as may be required in order to enable Braeburn to request reimbursement or deduction of the withheld amount, or to otherwise comply with its duties.  Knight and Braeburn agree to cooperate to legally minimize and reduce such withholding taxes and provide any information or documentation required by any taxing authority.

 

13.2                        Further Assurances.  Upon request by either Party and at such Party’s expense, the other Party shall do such further acts and execute such additional agreements and instruments as may be reasonably necessary to give effect to the purposes of this Agreement.

 

13.3                        Independent Status.  Each Party’s legal relationship under this Agreement to the other Party shall be that of independent contractor, and not partners or joint venturers.

 

13.4                        Assignment.  This Agreement may not be, directly or indirectly, assigned or otherwise transferred, in whole or in part, by a Party to a Third Party without the prior written consent of the other Party; provided, however, that each Party may assign this Agreement to (a) any of its Affiliate or (b) in connection with its acquisition or the transfer or sale of all or substantially all of its assets or its business to which this Agreement relates, without such consent; provided, further, that the assigning Party shall promptly notify the other Party of any such assignment.  The rights and obligations contained herein shall inure to the benefit of each Party’s successors and permitted assigns, and shall be binding on and enforceable against the relevant Party’s successors and permitted assigns.  Any reference in this Agreement to any Party shall be construed accordingly. Any purported assignment not in accordance with this Agreement shall be void.

 

41

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

13.5                        Compliance with Applicable Law.  In connection with their activities under this Agreement, each Party shall comply with, and shall not be in violation of, any Applicable Laws.

 

13.6                        Force Majeure.  No Party shall be responsible for a failure or delay in performance of any of the obligations hereunder due to any fire, flood, earthquake, explosion, storm, blockage, embargo, war, acts of war (whether war be declared or not), terrorism, insurrection, riot, civil commotion, strike, lockout or other labor disturbance, failure of public utilities or common carriers, act of God or act, omission or delay in acting by any Governmental Authority (such events being defined as “Force Majeure”), provided that the Party seeking relief from its obligations advises the other Party forthwith of the Force Majeure.  A Party whose performance of obligations has been delayed by Force Majeure shall use Commercially Reasonable Efforts to overcome the effect of the Force Majeure as soon as possible.  The other Party will have no right to demand indemnity for damage or assert a breach against such Party, provided, however, that if the event of Force Majeure preventing performance shall continue for more than [***] months and such underlying cause would not also prevent other parties from performing such obligations, then the Party not subject to the event of Force Majeure may terminate this Agreement with a written notice to the other without any liability hereunder, except the obligation to make payments due to such date and any obligations surviving under Section 11.4.

 

13.7                        Notices and Amendments.  Any notice or other communication required or permitted to be given hereunder shall be in writing and shall be given by facsimile or other means of electronic communication or by hand delivery as hereinafter provided.  Any such notice, if sent by fax or other means of electronic communication, shall be deemed to have been received on the day of sending, or if delivered by hand shall be deemed to have been received at the time it is delivered to the applicable address noted below.  Notices of change of address shall also be governed by this Section 13.7.  Notices and other communications shall be addressed as follows:

 

42

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(a)                                 In the case of Braeburn:

 

Braeburn Pharmaceuticals, Inc.

47 Hulfish Street

Suite 441

Princeton, NJ 08542

United States

Attention: General Counsel

 

with copies (which shall not constitute notice) to:

 

notices@braeburnpharma.com

 

and

 

Hogan Lovells US LLP

100 International Drive

Suite 2000

Baltimore, MD 21202

United States

Attention:                                         Asher Rubin

Fax:                                                                       +1 410 659 2701

E-mail:                                                        asher.rubin@hoganlovells.com

 

(b)                                 In the case of Knight:

 

Knight Therapeutics Inc.

376 Victoria Avenue

Suite 220

Westmount, Quebec, H3Z 1C3

Canada

Attention:                                         Jeffrey Kadanoff

Fax:                                                                       +1 514 481 4116

E-mail:                                                        jkadanoff@gud-Knight.com

 

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

 

Davies Ward Phillips & Vineberg LLP

1501 McGill College Ave.

Suite 2600

Montreal, Quebec H3A 3N9

Canada

Attention:                                         Hillel W. Rosen

 

43

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Fax:                                                                       +1 514 841 6400

E-mail:                                                        hrosen@dwpv.com

 

13.8                        Complete Agreement.  This Agreement, together with the SDEA and any quality agreement entered into between the Parties with respect to Sublicensed Products, and all exhibits, schedules and other attachments hereto or thereto, embodies all of the understandings and obligations between the Parties with respect to the Sublicensed Products and supersedes any prior or contemporaneous agreements and understandings, whether written or oral, between the Parties with respect to the subject matter hereof.  Any amendments or supplements to this Agreement shall not be valid unless executed in writing by duly authorized officers of both parties.

 

13.9                        Waiver.  No failure to exercise and no delay in exercising any right or remedy hereunder shall operate as a waiver thereof.  Any waiver granted hereunder shall only be applicable the specific acts covered thereby and shall not apply to any subsequent events, acts, or circumstances.

 

13.10                 Severability.  In the event any portion of this Agreement shall be held illegal, void or ineffective, the remaining portion hereof shall remain in full force and effect.  If any of the terms or provisions of this Agreement are in conflict with any applicable statute or rule of law, then such terms or provisions shall be deemed inoperative to the extent that they may conflict therewith and shall be deemed to be modified to conform with such statute or rule of law.

 

13.11                 Governing Law.  This Agreement all disputes arising out of or relating to this Agreement, or the performance, enforcement, breach or termination hereof or thereof, and any remedies relating thereto, shall be construed, governed by and interpreted in accordance with the laws of the State of New York without regard to any conflict of laws principle thereof that would result in the application of the laws of any other jurisdiction.

 

13.12                 Counterparts.  This Agreement may be executed in any number of counterparts, each of which shall be considered one and the same Agreement and shall become effective when a counterpart hereof has been signed by each of the Parties and delivered to the other Party.

 

13.13                 Time of Essence.  Time shall be of the essence of this Agreement and of each provision hereof.

 

13.14                 English Language.  At the request of the parties, this Agreement has been negotiated in the English language and will be or have been executed in the English language.  Les soussignes ont expressement demande que ce document et tous les documents annexes soient rediges en langue anglaise.

 

[Signature page follows]

 

44

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

IN WITNESS WHEREOF, the Parties have caused this Distribution and Sublicense Agreement to be signed by their duly authorized representatives as of the Effective Date.

 

 

	
BRAEBURN   PHARMACEUTICALS, INC.
    	
 
    	
KNIGHT   THERAPEUTICS INC.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Behshad Sheldon
    	
 
    	
By:
    	
/s/ Amal Khouri
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Behshad Sheldon
    	
 
    	
Name:
    	
Amal Khouri
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
President and CEO
    	
 
    	
Title:
    	
VP, Business Development
    

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

IN WITNESS WHEREOF, the Parties have caused this Distribution and Sublicense Agreement to be signed by their duly authorized representatives as of the Effective Date.

 

 

	
BRAEBURN   PHARMACEUTICALS, INC.
    	
 
    	
KNIGHT   THERAPEUTICS INC.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
 
    	
 
    	
By:
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
 
    	
 
    	
Name:
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
 
    	
 
    	
Title:
    	
 
    

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

SCHEDULE A

 

BRAEBURN MARKS

 

[To be provided separately]EXHIBIT 10.15

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

PRODUCT PURCHASE AND PHARMACY SERVICES AGREEMENT

 

THIS PRODUCT PURCHASE AND PHARMACY SERVICES AGREEMENT (this “Agreement”) between BRAEBURN PHARMACEUTICALS, INC., located at 47 Hulfish St., #441, Princeton, NJ 08542 (“Manufacturer”), and AVELLA OF DEER VALLEY, INC., located at 1606 W Whispering Wind Drive, Second Floor, Phoenix, AZ 85085, (together with its Approved Facilities “Pharmacy”), is effective as of September 1, 2016 (the “Effective Date”).  Manufacturer and Pharmacy may be referred to individually in this Agreement as “Party” or collectively “Parties”.

 

RECITALS

 

WHEREAS, Manufacturer markets and sells various pharmaceutical products;

 

WHEREAS, the United States Drug Enforcement Administration (“DEA”) has, by letter dated July 12, 2016, a copy of which is attached hereto as Exhibit A, provided written confirmation that it is permissible for Manufacturer to distribute its controlled substances intended for treatment of opioid dependence through a pharmacy directly to a healthcare practitioner (at its primary DEA address as set forth on an order form available through the Braeburn Access Program (the “Order Form”), unless other provider DEA address is denoted in writing by provider) for administration of the Product under certain conditions (the “DEA Letter”);

 

WHEREAS, Pharmacy has one or more locations that dispense pharmaceutical products to patients and has the ability and capacity to provide a broad range of bona fide services to pharmaceutical manufacturers;

 

WHEREAS, Manufacturer desires to appoint Pharmacy as an authorized dispenser of pharmaceutical products marketed and/or sold by Manufacturer and agrees to sell certain pharmaceutical products to Pharmacy pursuant to the terms and conditions of this Agreement; and WHEREAS, Pharmacy desires to accept such appointment and agrees to purchase the products from Manufacturer and to provide any other services subject to the terms and conditions described in the Agreement.

 

NOW, THEREFORE, in consideration of the premises and mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which the Parties hereby acknowledge, the Parties hereby agree as follows:

 

AGREEMENT

 

1.                                      Product Purchases.

 

1.1.                            Grant of Purchase Rights.  Subject to and in accordance with all of the terms and conditions of this Agreement, Manufacturer hereby grants to Pharmacy and its Approved Facilities, as set forth in Exhibit B (as may be amended from time to time by written agreement of the Parties) an exclusive (except as set forth in this Section 1.1), non-transferable, non-sublicensable, revocable right to purchase the product(s) as set forth in Exhibit C (“Products”).  Notwithstanding anything in

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

the foregoing to the contrary, Manufacturer may, by itself or through any of its third party vendors, sell Products to institutions for distribution within the institution.  Manufacturer reserves the right to modify or add any new strength or package size of a Product approved by the U.S. Food and Drug Administration, or any successor entity thereto (the “FDA”) to this Agreement at the same terms and conditions as the existing Product in this Agreement and to remove any Product (or, where applicable, Product NDC) from this Agreement, in its sole discretion in the event that the Product is removed from the general distribution in the market, by giving written or electronic notice to Pharmacy.

 

1.2.                            Purchase Pricing.  Product cost to Pharmacy and all associated terms and conditions shall be as stated in Exhibit C.  Manufacturer reserves the right to change the price of Product upon [***] days prior written notice to Pharmacy.

 

1.3.                            Product Payment.  Pharmacy shall pay Product invoices within [***] days of the date of receipt of such invoices.  If a payment date falls on a Saturday, Sunday or a federal holiday, Pharmacy may make payment on the next business day and still be in compliance with the payment terms.  If payment is not timely received, Manufacturer reserves the right to [***].

 

1.4.                            Orders; Delivery.  Pharmacy shall submit purchase orders to Manufacturer’s designated distributor set forth on Exhibit C (the “Distributor”), which Manufacturer may change, with [***] days’ prior written notice to Pharmacy, in its sole discretion, in a format mutually agreed upon by the Parties.  Manufacturer or its Distributor shall deliver Products to Pharmacy in accordance with Section 3 of Exhibit C.

 

1.5.                            Inventory and Back Orders.  Pharmacy shall use commercially reasonable and good faith efforts to ensure it maintains sufficient Product inventory.  Manufacturer shall use commercially reasonable efforts to notify Pharmacy in advance of any anticipated back-order of Product, but in no event later than [***] after Pharmacy has ordered Product.  Upon notice by the Manufacturer of a back-order, Pharmacy will have the right to cancel the order in whole or in part.  Manufacturer shall provide weekly written notification to Pharmacy of the status of all back-ordered Products.  If a Product is on back order for more than [***] days, Manufacturer will ship Product to Pharmacy on an expedited basis within [***] after such Product becomes available, at Manufacturer’s expense.

 

1.6.                            Shipment Inspections.  Promptly upon receipt of Product (and in any case, within [***] business days of receipt of Product), Pharmacy shall visually inspect the Product and shall promptly notify, and in any event within [***] days following receipt of a shipment of the Product, Manufacturer of any discrepancy in the order, shipment damage, or any visible defect (without the necessity of opening individual packaging), by giving written notice of the purchase order, number, invoice number, invoice date and all other necessary information to identify the shipment of Product.  Pharmacy shall also furnish Manufacturer with a detailed description of the nature of such visible defect, along with a signed bill of lading noting the defect.  Upon receipt of notice of any discrepancy, damage, defect or

 

2

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

non-delivery, Manufacturer will provide instructions regarding the return of the Product.

 

2.                                      Pharmacy Services.

 

2.1.                            Bona Fide Services.  Pharmacy will perform the services as set forth in Exhibit D (“Services”).  The Parties represent and warrant that Manufacturer has engaged Pharmacy to perform the Enhanced Services set forth in Section 2 of Exhibit D (the “Enhanced Services”) and that such Enhanced Services: (i) are bona fide, legitimate, reasonable, and necessary services; (ii) are not intended to serve, either directly or indirectly, as a means of marketing the Product, (iii) are not intended to diminish the objectivity or professional judgment of Pharmacy; (iv) are not intended to obligate, induce or reward Pharmacy for the past, present or future purchase, order or recommendation of Product; (v) do not involve the counseling or promotion of any unapproved use of the Products; and (vi) do not involve the counseling or promotion of a business arrangement or other activity that violates any Applicable Laws.

 

2.2.                            Bona Fide Service Fees.  In consideration for Pharmacy’s performance of the Enhanced Services set forth in Paragraph 2 of Exhibit D, Manufacturer shall pay Pharmacy service fees in accordance with Exhibit D (“Fees”).  The Pharmacy shall invoice Manufacturer for all Fees and pass through expenses no later than the [***] of each month and Manufacturer shall pay Pharmacy such undisputed invoiced Fees and pass-through expenses within [***] days of receipt of the invoice.  All invoices shall be delivered electronically to the attention of Accounts Payable at accounts.payable@braeburnpharma.com.  The Parties acknowledge that (i) unless otherwise agreed in writing the Fees provided hereunder will be Pharmacy’s sole, full and complete form of compensation provided by the Manufacturer for the Services; (ii) the Fees represent the fair market value of the Services, unless otherwise adjusted to comply with the limits on payment set forth in the “Refill Reminder Exception” to the definition of “Marketing” under the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), and the privacy and security regulations and related guidance promulgated by the Department of Health and Human Services (“HHS”) implementing HIPAA (the “HIPAA Regulations”), and have been negotiated at arms-length, in good faith by the parties; (iii) the Fees are not intended in any way as a payment related to a drug formulary or drug formulary activities and has not been negotiated or discussed between the Parties in connection with any such drug formulary or formulary activities; (iv) the Fees [***]; and (v) the Fees [***].  The Fees for the Services will be [***] during the term of this Agreement.  After termination or expiration of this Agreement, the Pharmacy shall calculate any final payment due, and Manufacturer shall pay any remaining amount owed within [***] days after receipt of the required data supporting the amount owed.  If there is a dispute over the amount of any final payment due hereunder, the parties agree to work promptly and cooperatively to resolve the dispute, and any undisputed amounts shall be paid promptly.  Except as otherwise set forth herein, Pharmacy shall be responsible for all costs and expenses associated with fulfilling its obligations and performing the Services.

 

3

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

3.                                      Term and Termination.

 

3.1.                            Agreement Term.  This Agreement shall have a term of two (2) years from the Effective Date, and shall automatically renew for successive one (1) year terms unless either Party sends a notice of non-renewal to the other Party at least sixty (60) days prior to the expiration of the term then in effect (“Term”).

 

3.2.                            Termination without Cause.  Either Party may terminate this Agreement without cause with sixty (60) days’ prior written notice to the other Party.

 

3.3.                            Termination for Cause.

 

3.3.1.                  Either Party may terminate this Agreement upon the occurrence of a material breach by the other Party.  The non-breaching Party must give written notice to the breaching Party of the nature and occurrence of such breach.  If the breach is not cured within thirty (30) days of such notice, or if the breach cannot reasonably be cured within such thirty (30) day period, then the non-breaching Party may provide written notice to the breaching Party that this Agreement will be terminated immediately.

 

3.3.2.                  Notwithstanding the forgoing, either Party may effect an immediate termination of this Agreement upon notice to the other Party if the other Party (i) shall be dissolved or apply for or consent to the appointment of a receiver, trustee or liquidator of all or a substantial part of its assets, (ii) file a voluntary petition in bankruptcy, (iii) admit in writing its inability to pay its debts as they become due, (iv) make a general assignment for the benefit of creditors, (v) file a petition or an answer seeking reorganization or arrangement with creditors or taking advantage of any insolvency law, or (vi) if an order judgment or decree shall be entered by a court of competent jurisdiction, on the application of a creditor, adjudicating such Party as bankrupt or insolvent or approving a petition seeking reorganization of such Party or appointing a receiver, trustee or liquidator of such Party of all or a substantial part of its assets.

 

3.4.                            Effect of Termination.  Termination shall have no effect upon the rights or obligations of the Parties arising out of any transactions occurring prior to the effective date of such termination.  Within fifteen (15) days of the termination or expiration of this Agreement, Pharmacy shall return all Products to Manufacturer then held by Pharmacy or Approved Facility in their inventory via a method determined by Manufacturer.  Manufacturer shall [***] in the event of termination by Manufacturer for Pharmacy’s material breach or bankruptcy under Section 3.3.  Upon expiration or termination of this Agreement, each Party shall return to the other all Confidential Information, deliverables (whether complete or incomplete), all equipment, and materials belonging to the other Party.  In the event of termination, provided that no undisputed Pharmacy invoices are outstanding and overdue, Pharmacy agrees to assist Manufacturer, upon Manufacturer’s request, in the decommissioning or transition of the Services to Manufacturer’s agent to ensure a smooth transition and uninterrupted service, at

 

4

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

a mutually agreed upon rate, by performing all reasonably required tasks and providing reasonable access to records specifically relating to the Services for a period of [***] following the termination of this Agreement, to the extent permissible by law.  Upon termination or expiration of this Agreement, Manufacturer agrees to pay to Pharmacy an amount corresponding to the work actually performed by Pharmacy until the date of termination of the Services and any and all costs and expenses associated with the termination and/or transition of the Services less any amounts which have been paid by Manufacturer to Pharmacy in advance for the work that will not be undertaken as a result of the termination of the Services.

 

4.                                      Returned Products and Recall.  Pharmacy may return Product in accordance with Manufacturer’s SPP Return Goods Policy, attached hereto as Exhibit E, which may be amended by Manufacturer, in its sole discretion from time to time.  Pharmacy shall also comply with the requirements governing the return of controlled substances set forth in 21 C.F.R. § 1317.10.  Manufacturer shall notify Pharmacy promptly of any recalls, field corrections, or market withdrawals with respect to any Product initiated by Manufacturer or required by the FDA.  Upon notice of a Product recall, field correction, or market withdrawal, Pharmacy shall promptly notify the affected patients of Pharmacy.  Manufacturer shall supply Pharmacy with the form of letter to be used in connection with the notice of any recall, field correction, or market withdrawal which shall contain appropriate instructions as to whether the Pharmacy patient should return or dispose of the affected Product.  Manufacturer shall [***], provided that the recall, field correction, or market withdrawal does not arise from (i) the gross negligence or intentional misconduct of Pharmacy or any of its agents or employees or (ii) failure of Pharmacy to comply with the terms of this Agreement.  Pharmacy shall cooperate in any recall, field correction, or market withdrawal, to the extent applicable, by, among other things, providing relevant Product tracking information to Manufacturer.  Reasonable and documented expenses shall include, but not be limited to, [***].  Pharmacy shall maintain for [***] years after termination or expiration of this Agreement such information as shall be reasonably required by Manufacturer to effect a Product recall, field correction, or market withdrawal after termination or expiration of this Agreement, and shall make such information available to Manufacturer, at Manufacturer’s request, in the event of such a recall.  Pharmacy shall cooperate with Manufacturer in investigating any Product failure which resulted in the need for a recall, field correction, or market withdrawal.

 

5.                                      Pharmacy Use and Handling of Product.

 

5.1.                            Storage and Handling.  Pharmacy shall keep Product stock in good and safe condition and shall permit inspection of Product stock and existing inventory records by Manufacturer during normal business hours upon reasonable advance notice by Manufacturer.  Pharmacy shall comply with the information and recommendations set forth in product labeling and any other commercially reasonable, lawful and appropriate directions communicated by Manufacturer in writing with respect to storage, handling and shipment of Product.  Pharmacy shall be responsible for costs associated with storage, handling and shipment of Product from Pharmacy.  Pharmacy shall comply with the physical security, recordkeeping and reporting requirements of the federal Controlled Substances

 

5

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Act, 21 U.S.C. §§ 801, et seq., and regulations promulgated thereunder (the “CSA”).

 

5.2.                            Pharmacy Use.  Pharmacy represents and warrants that it shall only use Product as permitted under Applicable Laws, including, but not limited to the Drug Supply Chain Security Act, 21 U.S.C. § 351 et seq. (“DSCSA”).

 

5.3.                            Trading Partners.  Manufacturer and Pharmacy represent and warrant that they are, and shall remain throughout the Term, an authorized trading partner within the meaning of the DSCSA.

 

5.4.                            No Diversion.  Pharmacy shall not distribute any (i) expired, defective, adulterated or misbranded, counterfeit or out of specification Product that is diverted from planned destruction, (ii) Product acquired, repackaged, and sold by a third party in a standard or customary size or unit of measure that Manufacturer currently offers for sale in the Territory, or (iii) Product sold by Manufacturer for use in non-domestic markets which is subsequently sold or imported for sale or use in the Territory should such Products come into Pharmacy’s possession.  Pharmacy shall deliver any such diverted Product to Manufacturer at cost to Manufacturer.  For purposes of this Section 5.3, “Territory” shall mean the United States (including its territories and possessions).  If and when Pharmacy has knowledge of any entity or person offering, selling or purchasing diverted Products, Pharmacy shall promptly provide written notice to Manufacturer describing information concerning diverted Product.  Pharmacy shall comply with its obligation to maintain effective controls against diversion under 21 C.F.R. § 1301.71(a).

 

5.5.                            Pharmacy Administration of Co-Pay Support Program.  Manufacturer shall be responsible for its Patient Assistance Programs, including the Braeburn Patient Assistance Program and the Probuphine Patient Copay/Co-lnsurance Assistance Program, which provide financial support for patient co-payments for the Product.  Pharmacy will participate in and secure reimbursement from Manufacturer for Manufacturer Patient Assistance Programs for the Product, whether administered by Manufacturer or any other third party on behalf of Manufacturer, including but not limited to RxC Acquisition Company d/b/a RxCrossroad, in accordance with terms and conditions to be captured in an executed writing to be completed within 30 days of the Effective Date of this Agreement and incorporated herein as Exhibit G.

 

5.6.                            Pharmacy Dispense of Product.  Pharmacy shall ship Product to patients’ health care provider provider (at the healthcare provider’s primary DEA address as set forth on the Order Form, unless such provider identifies a different DEA address for shipping purposes on the Order Form) via an industry recognized overnight delivery carrier capable of order delivery tracking and in accordance with a valid prescription, Applicable Laws (as defined in Para. 6.1) and regulations and guidelines and standards applicable to Pharmacy.  Pharmacy shall ship Product within [***] after determining that a prescription has been cleared for shipment.  Pharmacy shall use reasonable efforts to ship Product having the earliest

 

6

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

expiration date from available inventory.  Pharmacy shall be responsible for billing and collection in connection with sale of Product and for costs associated with distribution and delivery of Product to its patients or their health care providers.  Pharmacy shall employ processes and procedures to ensure, prior to delivery of Products to a health care provider, that the provider is registered to prescribe controlled substances under the CSA (21 U.S.C. § 823(f)), holds a current DATA 2000 waiver under 21 U.S.C. § 823(g), and is certified under the Product’s REMS program (the “Product REMS Program”).  Pharmacy shall only dispense Product pursuant to a prescription for an individual identified patient. Pharmacy shall require that the certified provider or an authorized employee sign a delivery confirmation upon receipt of Products.  Pharmacy shall treat its actions hereunder as dispensing for purposes of the CSA and DEA regulations and with all applicable requirements thereunder, including, but not limited to, keeping records indicating that the controlled substance was delivered to the practitioner and including the practitioner’s name and address of the registered location to which it was delivered.

 

6.                                      Mutual Representations, Warranties, and Covenants.

 

6.1.                            Compliance with Law.  The Parties agree to comply with all applicable laws (federal, state and local) connected with or related to the purchase, warehousing, distribution, dispensing, sale, return or destruction of Products purchased under this Agreement, including, but not limited to, (i) healthcare or insurance fraud or abuse laws, including the following statutes and the regulations promulgated thereunder: the Federal anti-kickback law (42 U.S.C. § 1320a-7b(b)), the Federal False Claims Act (31 U.S.C. §§ 3729, et seq.), the Federal Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Federal Program Fraud Civil Remedies Act (31 U.S.C. § 3801 et seq.) and the Federal Health Care Fraud Law (18 U.S.C. § 1347); (ii) the HIPAA and HITECH privacy and security laws; (iii) controlled substances laws relating to the collection, manufacture, processing, holding, storing, testing, packaging, repackaging, importing, exporting, dispensing, destroying and distribution of controlled substances, including but not limited to all applicable provisions of the CSA.; (iv) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301, et seq.) (the “FDCA”), (v) the DEA Letter, and (vi) any other laws and regulations relating to the terms of this Agreement (collectively, “Applicable Laws”).

 

6.2.                            Licenses and Permits.  The Parties shall comply fully with the provisions of all Applicable Laws and shall obtain and maintain all federal, state and local approvals, licenses, permits, registrations and certifications required of their respective operations that would have a material impact on the Party’s obligations under this Agreement.  Any and all necessary requests for renewal of any such approvals, licenses, permits, registrations, and certifications have been filed with the appropriate governmental authority, to the extent necessary to meet materials obligations under this Agreement, and neither Party has received any written notice or correspondence from the FDA, the DEA, or any comparable governmental authority that such governmental authority is considering limiting, suspending, or revoking any approval, license, permit, registration, or certification

 

7

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

that would have a material impact on either Party’s obligations under this Agreement.  Neither Party shall undertake any activities which contravene this subsection in the performance of this Agreement.  Upon commercially reasonable request by either Party, the other Party or any agent acting on behalf of the Party shall provide proof of licensure that would have a material impact on either Party’s obligations under this Agreement.  Each Party shall notify the other, within [***] business days, of any suspension, revocation, condition, limitation, qualification or other restriction on any such approval, license, permit, registration or certification which would impede that Party in the performance of its obligations under this Agreement.

 

6.3.                            Organization; Authority; Execution.  Each Party represents and warrants that (i) it is a corporation duly organized, validly existing and in good standing under the laws of the state of its incorporation, (ii) it has the corporate power and authority to enter into this Agreement and to carry out the provisions hereof, (iii) it has taken all necessary corporate actions to authorize the execution, delivery and performance of this Agreement, (iv) this Agreement has been duly executed and delivered on behalf of it, and constitutes a legal, valid and binding obligation, enforceable against it in accordance with the terms hereof, except as enforcement may be affected by bankruptcy, insolvency or other similar laws and by general principles of equity.

 

6.4.                            No Conflicts.  Each Party represents and warrants that its execution of this Agreement and its performance of its obligations hereunder do not conflict with and are not prohibited by or inconsistent with any other agreement to which it is a party.  Each Party further represents and warrants that the performance of its other obligations under this Agreement are neither (i) inconsistent with its obligations to any third party, including without limitation its customers, nor (ii) in any manner inconsistent with Applicable Laws.

 

6.5.                            Independent Judgment.  The Parties acknowledge that any discount offered under this Agreement is not intended to usurp the independent professional and/or clinical decision-making of any Pharmacy employee or health care professional, or interfere with the formulary plan benefit design of payers.

 

6.6.                            Debarment; Exclusion, Each Party represents and warrants that neither it nor any of its employees or representatives has been or is debarred pursuant to the FDCA or has been or is excluded from participating in a federal health care program, including without limitation the Medicare and Medicaid programs.  Moreover, each Party covenants that in the event it or any of its employees or representatives is subsequently debarred under the FDCA or excluded from a federal health care program during the term hereof, it shall notify the other, within five (5) business days.

 

7.                                      Manufacturer Representations, Warranties and Covenants.

 

7.1.                            General Representation, Warranties and Covenants.  Manufacturer represents and warrants that it will have good title to the Product, free and clear of all

 

8

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

security interests, liens or other encumbrances of any kind or character, delivered to Pharmacy under this Agreement; has, and at all times during the Term shall maintain, all governmental licenses, permits and approvals required to market, promote, offer for sale and sell Product in the Territory and to conduct all other activities required under this Agreement; will comply with all Applicable Laws relating to the promoting and distributing of the Product, and the Product has been approved under all such laws, rules and regulations for the distribution and dispensing contemplated by this Agreement; and Product supplied will be in conformity with Product specifications set forth in the approved Product labeling and with all other Applicable Laws.  Manufacturer further represents that each shipment of Product delivered pursuant to this Agreement may, as of the date of delivery, be introduced or delivered into interstate commerce pursuant to Applicable Laws, including applicable provisions of the FDCA, Section 351 and the Public Health Service Act, 42 U.S.C. § 262, and their implementing regulations, each as amended and in effect at the time of shipment or delivery of such Product and will not, on the date of shipment or delivery by Manufacturer, be adulterated, misbranded or otherwise prohibited under Applicable Laws in effect at the time of shipment or delivery of such Product.

 

7.2.                            Regulatory and REMS Representations.  Manufacturer further represents that REMS requirements imposed by the FDA under FDCA 505-1 (“REMS Program”) allow for the Pharmacy to (a) receive the Product pursuant to a wholesale transaction from Manufacturer’s authorized distributor, (b) dispense the Product on a patient specific basis pursuant to a prescription written by a certified prescriber as defined in the REMS Program (“Certified Prescriber”), (c) deliver the Product directly to a healthcare practitioner in accordance with DEA requirements regarding shipment to an address where a healthcare practitioner will administer a controlled substance; (d) that Pharmacy shall not have any requirements for compliance with the REMS Program except as directed by Manufacturer in writing, and (e) that Pharmacy may rely on information as provided by the Manufacturer or its Distributor stating that a physician is a Certified Prescriber as defined in the REMS Program.

 

8.                                      Pharmacy Representations, Warranties and Covenants.

 

8.1.                            Pharmacy Discount Reporting Obligations.  To the extent required by Applicable Laws, Pharmacy shall fully and accurately disclose and report in accordance with the requirements of the federal healthcare anti-kickback statute (42 U.S.C. § 1320a-7b(b), and its implementing safe harbor regulations for discounts (42 C.F.R. § 1001.952(h), as well as any other applicable state law or payer reimbursement requirements, any discounts, rebates or price concessions provided by Manufacturer to Pharmacy.  To the extent required by Applicable Laws, Pharmacy agrees that, upon the request of the U.S. Department of Health and Human Services or a state healthcare agency, it will fully disclose all discounts and price concessions offered under this Agreement.

 

8.2.                            Product Promotion.  Pharmacy will not promote the Product, but Pharmacy may promote its own services to its customers in accordance with Pharmacy’s

 

9

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

standard business practices, which typically include (but are not necessarily limited to) informing its customers of pricing available for products distributed by Pharmacy.  Accordingly, Pharmacy shall not distribute or generate any promotional material containing claims relating to the Product.  Pharmacy may, however, pursuant to the practice of pharmacy, provide its customers with educational information concerning the Product, provided that such information is consistent with the FDA-approved prescribing information for the Product.

 

8.3.                            Pharmacy Core Services.  Pharmacy represents and warrants that as part of its normal pharmacy operations it, without compensation from any third-party, (i) possesses the necessary capabilities, facilities, technology, personnel and expertise to enable it to perform the core services set forth in Paragraph 1 of Exhibit D, and its obligations hereunder; (ii) provides prescription receipt, data entry services, dispensing, reimbursement services, financial services, including investigation of third party financial assistance, shipping and inventory management services; (iii) provides twenty-four (24) hour access to clinical support through qualified nurses, case managers, pharmacists or other personnel who are adequately trained and experienced in educating patients and providers on administering the Product in an appropriate manner consistent with all Applicable Laws, including state licensing laws; and (iv) provides adverse event and product complaint reporting (the “Core Services”)..  Pharmacy agrees and acknowledges it shall not invoice Manufacturer for the performance of any Core Services.

 

8.4.                            Regulatory Compliance.

 

8.4.1.                  Pharmacy represents and warrants that it is in compliance with applicable FDCA provisions and FDA regulations, including without limitation those regarding licensure, storage and handling, recordkeeping and reporting requirements, and applicable controlled substances laws, including without limitation the CSA.

 

8.4.2.                  Pharmacy will comply with specific REMS requirements imposed by the REMS Program as directed by Manufacturer in writing and as accepted by Pharmacy in its reasonable discretion (collectively “Manufacturer Directed REMS Requirements), including without limitation the following:

 

(i)                                     including a copy of the Medication Guide with each individual shipment of the Product;

 

(ii)                                  following those processes and procedures provided by Manufacturer in writing and as accepted by Pharmacy in its reasonable discretion to confirm with Distributor, prior to shipping the Product, that the healthcare providers who prescribe the Product are Certified Providers and registered with the DEA;

 

(iii)                               complying with all requests to be audited by, or on behalf of, Manufacturer or FDA to ensure that all Manufacturer directed processes

 

10

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

and procedures are in place and are being followed for the Product’s REMS Program; and

 

(iv)                              maintaining distribution records of all shipments of the Product and, on a frequency no less than monthly, providing such data to Manufacturer.

 

MANUFACTURER ACKNOWLEDGES THAT PHARMACY IS ACTING SOLELY AT THE DIRECTION OF THE MANUFACTURER IN ADMINISTERING THE REMS REQUIREMENTS AND THAT PHARMACY HAS NO INDEPENDENT DUTY TO INTERPRET THE REQUIREMENTS FOR COMPLIANCE WITH THE REMS OR TO IMPLEMENT ANY ACTIONS BEYOND THE MANUFACTURER DIRECTED REMS REQUIREMENTS.

 

8.4.3.                  Pharmacy will not, unless expressly authorized in writing by Braeburn, directly receive any prescriptions from healthcare providers.  Pharmacy agrees to refer all incoming orders from healthcare providers to the Distributor for initial processing and REMS-verification.

 

Pharmacy represents and warrants that it is, and covenants to maintain its status as, an Authorized Trading Partner in compliance with the DSCSA.

 

8.5.                            Approved Facilities.  Within a commercially reasonable time frame and upon written request by Manufacturer, Pharmacy will provide Manufacturer with the following information with respect to any Approved Facility set forth on Exhibit B: (i) state board licensure number, classification, date issued and expiration number, (ii) FDA registration information, if applicable (e.g., manufacture, repackage, re-label, and wholesale distributor), (iii) DEA registration number, if applicable, (iv) business activity, (v) current registration year or (vi) other information reasonably requested and required by Manufacturer.

 

9.                                      Data Restrictions.  Pharmacy and Manufacturer acknowledge and agree that Manufacturer is not requesting Pharmacy to provide, and Pharmacy shall not provide any data or information to Manufacturer in any report in the event the transfer, use, license, sale or disclosure of such data or information by Manufacturer or Pharmacy is prohibited by Applicable Laws, including, but not limited to, federal or state laws and regulations that prohibit or restrict the transfer, use, license, sale or other disclosure of prescriber data.

 

10.                               Confidentiality.

 

10.1.                     Definition.  “Confidential Information” means all business and proprietary information of a Party (the “Disclosing Party”) disclosed to the other Party (the “Receiving Party”), whether or not labeled or identified as “Confidential,” including, without limitation, the terms of this Agreement, pricing materials, and the respective business and financial information of the Parties.  Confidential Information shall not include any information that (i) is or has become publicly

 

11

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

available through no fault of the Receiving Party, (ii) that is rightfully obtained from third parties who are not bound by any confidentiality requirement, or (iii) that the Receiving Party previously knew about, other than by disclosure of the Disclosing Party, as documented by business records.

 

10.2.                     Non-Use and Non-Disclosure.  All Confidential Information shall be kept in strict confidence by the Receiving Party and shall not be disclosed to any third party or used for any purpose except as expressly permitted herein without the prior written consent of the Disclosing Party.  Notwithstanding the foregoing, the Receiving Party may disclose such Confidential Information (i) to employees, agents, subcontractors or consultants on an as-needed basis, provided such persons are bound under substantially similar confidentiality restrictions; (ii) to the extent requested or required by court order, legal process, or Applicable Laws, provided that the Receiving Party (a) provides the Disclosing Party prompt advance written notice thereof (to the extent permitted by Applicable Laws) to allow the Disclosing Party to seek a protective order with respect to such disclosure, and (b) thereafter discloses only the minimum information required to be disclosed in order to comply; or (iii) as expressly authorized in writing by the Disclosing Party.

 

10.3.                     Survival.  The Parties’ obligations of confidentiality hereunder shall survive termination of this Agreement, and shall be in addition to, and not in place of, any other non-disclosure and/or confidentiality obligations that the Parties may otherwise agree upon.  Nothing contained herein shall be deemed to grant to either Party any rights or licenses under any patent applications or patents or to any know-how, technology, inventions or other intellectual property rights of the other Party.

 

11.                               Use of Trademarks.  Pharmacy shall not use the trademarks or tradenames of Manufacturer except to the extent contained in Product literature provided by Manufacturer and on Product labels or as otherwise approved by Manufacturer.  Manufacturer shall not use the trademark or tradenames of Pharmacy without the prior written approval of Pharmacy.  Neither party will have the right to issue a press release, statement or publication regarding the terms and conditions of or the existence of this Agreement without the prior written consent of the other party.

 

12.                               Audit.

 

12.1.                     Pharmacy shall keep complete and accurate books and records, including electronic data, relating to the transactions and Services identified herein for the longer of (i) [***] years from creation thereof; or (ii) as required by Applicable Laws.  Upon [***] days’ advance written notice, at its own expense, during Pharmacy’s regular business hours, and no more frequently than once annually, Manufacturer (and/or its designee) shall have the right, during the Term of this Agreement, and for a period of [***] thereafter, to inspect and audit the books and records of Pharmacy, with or without cause, for the purposes of (a) verifying compliance with this Agreement, Applicable Laws and/or the Product’s REMS Program and (b) satisfying Manufacturer’s obligations to FDA to inspect and audit

 

12

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

pharmacies that dispense the Product (including obligations articulated in written or verbal instructions or requests received by Manufacturer from FDA).  In addition to the foregoing audit right, Manufacturer (and/or its designee) shall have the right to audit Pharmacy within [***] calendar days after the Effective Date to ensure that all processes and procedures are in place and functioning to support the requirements of the Product’s REMS Program.  If Manufacturer determines after any such audit that Pharmacy is not in compliance with the Product’s REMS Program, Pharmacy shall, at its expense, institute such processes and procedures as are necessary to ensure compliance with the Product’s REMS Program.

 

12.2.                     Notwithstanding anything to the contrary in Section 12.1, Manufacturer may conduct additional audits without providing prior notice (i) in the event any audit conducted by Manufacturer or an audit by a regulatory Authority reveals a material compliance deficiency, or (ii) as reasonably necessary to comply with Applicable Laws, the Product’s REMS Program or requests from governmental authorities, including without limitation, FDA.

 

13.                               Indemnification.

 

13.1.                     Manufacturer’s Indemnification Obligation.  Manufacturer will [***].

 

13.2.                     Pharmacy’s Indemnification Obligation.  Pharmacy will [***].

 

13.3.                     Limitation of Liability.  EXCEPT FOR CLAIMS FOR (I) INDEMNIFICATION UNDER SECTIONS 13.1 OR 13.2, (II) PERSONAL INJURY DUE TO NEGLIGENCE, (III) WRONGFUL DEATH, (IV) GROSS NEGLIGENCE, (V) WILLFUL MISCONDUCT, OR (VI) FRAUD, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, INDIRECT, EXEMPLARY OR PUNITIVE DAMAGES ARISING OUT OF RELATING TO THIS AGREEMENT.  EXCEPT FOR CLAIMS FOR (A) INDEMNIFICATION UNDER SECTIONS 13.1 OR 13.2, (B) PERSONAL INJURY DUE TO NEGLIGENCE, (C) WRONGFUL DEATH, (D) GROSS NEGLIGENCE, (E) WILLFUL MISCONDUCT, OR (F) FRAUD, THE ENTIRE LIABILITY OF EITHER PARTY TO THE OTHER IN CONNECTION WITH THE SERVICES AND ANY AGREEMENT BETWEEN THE PARTIES RELATING THERETO (WHETHER BASED ON BREACH OF CONTRACT, BREACH OF WARRANTY, NEGLIGENCE OR ANY OTHER LEGAL THEORY) SHALL NOT EXCEED, IN THE AGGREGATE, [***] UNDER THIS AGREEMENT.

 

14.                               Insurance.  Pharmacy shall maintain in effect during the term of this Agreement a comprehensive general liability policy underwritten by an insurance company that carries an [***] or better rating from A.M. Best.  This comprehensive insurance policy shall be in an amount not less than [***] per occurrence.  Pharmacy shall provide [***] days’ notice to Manufacturer in the event of any cancellation, or termination thereof.  Pharmacy shall provide Manufacturer with a certificate of insurance evidencing compliance with this Section upon execution of this Agreement.  The amount of such required insurance coverage under this Section shall not limit Pharmacy’s obligations under this Agreement.

 

13

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

15.                               Miscellaneous.

 

15.1.                     Assignability and Notice of Change of Control.  Except as specifically provided herein, this Agreement, or any of the rights or obligations created herein, may not be assigned, in whole or in part, by either Party without the written consent of the other Party; provided, however, that either Party may assign this Agreement without the consent of the other Party to (i) any affiliate or (ii) in connection with the acquisition, sale or other transfer of all or substantially all of its assets or business to which this Agreement relates.  The rights and obligations contained herein shall inure to the benefit of each Party’s successors and permitted assigns, and shall be binding on and enforceable against the relevant Party’s successors and permitted assigns.  Any purported assignment not in accordance with this Agreement shall be void.

 

15.2.                     Amendment.  This Agreement may only be amended, modified or supplemented by an agreement in writing signed by each Party hereto.  No waiver by any Party of any of the provisions hereof shall be effective unless explicitly set forth in writing and signed by the Party so waiving.  Except as otherwise set forth in this Agreement, no failure to exercise, or delay in exercising, any rights, remedy, power or privilege arising from this Agreement shall operate or be construed as a waiver thereof; nor shall any single or partial exercise of any right, remedy, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege.

 

15.3.                     Non-Exclusivity.  Subject to Section 1.1, Manufacturer and Pharmacy mutually agree that this Agreement is non-exclusive and that each party is free to contract and deal with other parties, including competitors of the other.  During the Term, Pharmacy shall not enter into any agreement which will cause it to be in breach or default or conflict with Pharmacy’s obligations under this Agreement.

 

15.4.                     Force Majeure.  The performance by either Party hereunder shall be excused to the extent of circumstances beyond such Party’s reasonable control, including, without limitation, hurricane, tropical storm or depression, extended power outages, flood, tornado, earthquake, or other natural disaster, epidemic, war, acts of terrorism, material destruction of facilities, fire, or acts of God.  In such event, the affected Party will, as promptly as reasonably possible, give the other Party written notice thereof and all obligations under this Agreement will be immediately suspended for the duration of the force major event (except for those rights and obligations that have already accrued); provided that the affected Party promptly undertakes all reasonable efforts necessary to cure such force major event; provided, further, that if performance is not restored within ninety (90) days, either Party may terminate this Agreement upon thirty (30) days’ prior written notice.  As a matter of clarify, Pharmacy may purchase Product from other parties during any such force major event which limits Manufacturer’s ability to perform.

 

15.5.                     Notices.  Any notices to be given by either Party to the other shall be in writing and may be transmitted either by electronic mail, courier, personal delivery or by

 

14

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

registered or certified mail (postage prepaid with return receipt requested).  Mailed notices shall be addressed to the Parties at the addresses appearing in this paragraph.  Each Party may change its address by written notice in accordance with this paragraph.  Notices shall be deemed communicated as of the date of actual receipt (which in the case of mailed notices shall be evidenced by a receipt evidencing delivery).

 

Manufacturer:

 

Braeburn Pharmaceuticals, Inc.
 47 Hulfish St., #441
 Princeton, NJ 08542
 Attn: Chief Financial Officer

 

With a copy to:
 notices@braeburnpharma.com

 

Pharmacy:

 

Avella of Deer Valley, Inc.
 1606 W. Whispering Wind Dr.
 Second Floor
 Phoenix, AZ 85085
 Attn: Leslie Yendro, VP of Business
 Development

 

With a copy to:
 Avella of Deer Valley, Inc.
 24416 N. 19th Ave.
 Phoenix, AZ 85085
 Attn: Office of the General Counsel

 

15.6.                     Governing Law.  This Agreement shall be governed by, construed and interpreted under and in accordance with the laws of the State of Delaware excluding its conflicts of laws principles.  The exclusive jurisdiction, forum and venue for any action to enforce or interpret this Agreement shall be in the state or federal courts located Delaware.  The parties agree to waive the right to a jury trial in all actions arising under or relating to this Agreement.

 

15.7.                     Complete Agreement.  As of the Effective Date, this Agreement and any other agreements mentioned herein represent the entire agreement between the Parties hereto with respect to the subject matter hereof.  There are no understandings, representations or warranties of any kind except as expressly set forth herein.

 

15.8.                     Construction, Modification and Waiver.  If any of the provisions of this Agreement are held void or unenforceable, the remaining provisions shall nevertheless be effective, the intent being to effectuate this Agreement to the fullest extent

 

15

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

possible.  Any headings contained herein are for directory purposes only, do not constitute a part of this Agreement, and shall not be employed in interpreting this Agreement.  Any modification of this agreement shall be in writing and shall be signed by authorized representatives of both Manufacturer and Pharmacy.  Any attempt to modify this Agreement orally or in writing not executed by authorized representatives of all Parties hereto shall be void.  A waiver of any breach of any provision of this Agreement shall not be construed as a continuing waiver of other breaches of the same or other provisions of this Agreement.

 

15.9.                     Survival.  Unless otherwise expressly provided herein, only Sections 4, 5,10,11,12,13, and 15 survive the termination or expiration of this Agreement, as the case may be.

 

15.10.              Relationship of the Parties.  The Parties hereto are independent contractors.  Nothing herein contained shall be deemed to create a joint venture, agency or partnership relationship between the Parties hereto.  Neither Party shall have any power to enter into any contracts or commitments in the name of, or on behalf of, the other Party, or to bind the other Party in any respect whatsoever.

 

15.11.              Change in Law.  In the event that any federal, state or local law, rule, regulation, policy, or any interpretation thereof, during the term of this Agreement, is modified, implemented, threatened to be implemented, or determined to prohibit, restrict or in any way materially affect this Agreement or either Party’s performance under the terms of this Agreement (each of the foregoing being hereinafter referred to as a “Change”), then the Parties to this Agreement shall promptly negotiate in good faith to amend this Agreement to preserve the expectations of the Parties to the greatest extent possible in a manner consistent with any such Change.  If this Agreement is not amended in writing as aforesaid prior to the effective date of the Change, this Agreement shall terminate, unless otherwise agreed upon by the Parties hereto, and upon such termination, neither Party shall have any further rights hereunder, except those rights already accrued and those that expressly survive termination.

 

[Signature Page Follows]

 

16

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

IN WITNESS THEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.

 

	
Manufacturer,
    	
 
    	
Pharmacy
    
	
BRAEBURN PHARMACEUTICALS INC.
    	
 
    	
AVELLA OF DEER VALLEY, INC
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/   Marshall H. Woodworth
    	
 
    	
By:
    	
/s/ Rebecca M. Shanahan
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Marshall   H. Woodworth
    	
 
    	
Name:
    	
Rebecca M. Shanahan
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
Chief   Financial Officer
    	
 
    	
Title:
    	
Chief Executive Officer
    

 

[Signature Page to Product Purchase and Pharmacy Services Agreement]

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

EXHIBIT A

 

DEA CONFIRMATION LETTER

 

See attached.

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Jonathan M. Young, Ph.D., J.D.
 General Counsel
 Braeburn Pharmaceuticals
 47 Hulfish Street, Suite 441
 Princeton, New Jersey 08542

 

Dear Dr. Young:

 

This responds to your letter to the Drug Enforcement Administration (DEA) dated June 8, 2016, in which you inquired about a pharmacy delivering controlled substances to the prescribing practitioner, rather than directly to the patient, under certain circumstances.

 

As you know, as a general matter, the DEA cannot provide individuals with definitive, private legal opinions about whether their particular activities relating to controlled substances comply with the requirements of the Controlled Substances Act (CSA) and DEA regulations.  Among the reasons for this is that such letters cannot establish a rule that is legally binding on the recipient or the agency.  At the same time, the DEA recognizes the importance of working with regulated entities to help guide them toward compliance with the law and regulations.  In that vein, we can provide the following general information.

 

For purposes of this letter, we will address the following hypothetical scenario:

 

·                  A DEA-registered practitioner, acting in the usual course of his/her professional practice, issues a prescription for a controlled substance for a legitimate medical purpose, and the prescription complies in all other respects with DEA regulations.

 

·                  The practitioner determines, in the exercise of his/her sound medical discretion, that it is appropriate for the practitioner to administer the controlled substance directly to the patient at the practitioner’s registered location.

 

·                  The prescription is for a single dose of the controlled substance for a particular patient - not a take-home supply for that patient and not for the practitioner’s office stock.

 

·                  The practitioner indicates on the prescription that the controlled substance should be delivered by the pharmacy to the practitioner, at his/her registered location, for administration to the patient.

 

·                  The above activity is carried out in compliance with applicable State law and regulations.

 

Neither the CSA nor DEA regulations specifically address the foregoing scenario.  Nonetheless, assuming all the foregoing facts apply, the DEA would consider it permissible under the CSA and DEA regulations for the pharmacy to deliver the controlled substance to the practitioner, at his/her registered location, provided the following conditions are met:

 

·                  The pharmacy treats its actions as a dispensing for purposes of the CSA and DEA regulations and complies with all applicable requirements thereunder.  This includes, but

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

is not limited to, keeping records indicating that the controlled substance was delivered to the practitioner and including the practitioner’s name and address of the registered location to which it was delivered.

 

·                  The practitioner treats his/her actions as administering for purposes of the CSA and DEA regulations and complies with all applicable requirements thereunder.  This includes, but is not limited to, keeping records, to the extent required for the administering of controlled substances, and maintaining security as required by the regulations.

 

Finally, please be advised that while this letter represents the current view of the DEA, it is not a binding rule.  The DEA is continuing to evaluate the issues related to your inquiry to determine whether it would be appropriate for the agency to propose an amendment to its regulations to specifically address this topic.

 

For information regarding the DEA Office of Diversion Control and electronic copies of the Federal Register notices mentioned above, please visit www.DEAdiversion.usdoj.gov.  If you have any additional questions on this issue, please contact the Office of Diversion Control Liaison and Policy Section at (202) 307-7297.

 

	
 
    	
Sincerely,
    
	
 
    	
 
    
	
 
    	
/s/ Louis   J. Milione
    
	
 
    	
Louis J. Milione
    
	
 
    	
Deputy Assistant   Administrator
    
	
 
    	
Office of Diversion   Control
    

 

2

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

EXHIBIT B

 

APPROVED FACILITIES

 

	
Avella of Scottsdale, Inc.
 9777 N 91st St., Ste. 102
 Scottsdale, Arizona 85258-5087
    
	
 
    
	
Avella of Deer Valley, Inc.
 23620 N 20th Dr., Ste. 12
 Phoenix, AZ 85085-0621
    
	
 
    
	
Avella of Tucson, Inc.
 4512 E Camp Lowell Drive
 Tucson, Arizona 85712-1282
    
	
 
    
	
Avella of Phoenix III, Inc.
 1101 N. Central Ave., Ste. 102
 Phoenix, AZ 85004
    
	
 
    
	
Avella of Columbus, Inc.
 4830 Knightsbridge Blvd., Ste. C
 Columbus, OH 43214-2300
    
	
 
    
	
Avella of Las Vegas II, Inc.
 701 Shadow Ln., Ste. 110
 Las Vegas, NV 89106-4132
    
	
 
    
	
Avella of St. Louis, Inc.
 450 N. New Ballas Rd., Ste. 256
 St. Louis, MO 63141-6836
    

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

	
Avella of Sacramento, Inc.
 2288 Auburn Blvd., Ste. 102
 Sacramento, CA 95821-1619
    
	
 
    
	
Avella of Austin, Inc.
 3016 Guadalupe St., Ste. A
 Austin, TX 78705-2862
    
	
 
    
	
Avella of Denver, Inc.
 1245 E. Colfax Ave., Ste. 102
 Denver, CO 80218
    
	
 
    
	
Avella of Orlando, Inc.
 100 Technology Park, Ste. 155
 Lake Mary, FL 32746
    
	
 
    
	
Avella of Deer Valley, Inc.
 24416 N. 19tf1 Avenue
 Phoenix, AZ 85085
    

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

EXHIBIT C

 

PRODUCTS

 

1.              Products.  Products shall include the following:

 

	
Product
    	
 
    	
NDC
    	
 
    	
Package Size
    	
 
    	
Price
    
	
Probuphine
    	
 
    	
58284-100-14
    	
 
    	
1 kit (4 non-biodegradable rods)
    	
 
    	
[***]
    

 

2.              Pricing.  The parties agree to negotiate in good faith if any pricing methodology is required to implement a percentage discount from WAC.

 

3                 Distribution.

 

a.              Pharmacy shall order Product through the Distributor, which is initially RxC Acquisition Company d/b/a RxCrossroads.  Manufacturer reserves the right to change its Distributor for Product as set forth in Section 1.4, including a change whereby Manufacturer will be the Distributor.

 

b.              Manufacturer, or its Distributor, shall deliver Products to Pharmacy or its designee FOB (Delivery Location) in accordance with reasonable instructions given by Pharmacy in the applicable purchase order.  Title and risk of loss passes to Pharmacy immediately upon release at the Delivery Location.  As used in this Section 3(b), the term “Delivery Location” shall mean Pharmacy’s (or an Approved Facility’s) address specified on the applicable purchase order.

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

EXHIBIT D

 

SERVICES AND SERVICE FEES

 

Pharmacy shall provide the Services for the Products described herein, in accordance with the terms of this Agreement.

 

1.              Core Services.

 

1.1.                Dedicated Phone/Fax.  Pharmacy shall provide a dedicated phone and fax line twenty-four (24) hours a day and seven (7) days a week for use by patients and healthcare providers in regard to Products and Services.  Pharmacy and Manufacturer will mutually agree on written instructions or restrictions regarding permissible communications between Pharmacy and customer.  Once mutually agreed upon in writing, Pharmacy personnel must use any materials provided by Manufacturer as guidelines for customer communications.

 

1.2.                Prescription Intake and Processing.  Pharmacy will only accept prescriptions after orders are first processed by the Distributor for verification of REMS certification.

 

1.3.                Data entry and Order Processing.  Pharmacy shall capture all prescription information and patient demographics in pharmacy dispensing system:

 

1.4.                Insurance Investigation and Eligibility.  Pharmacy shall perform a full investigation of patient insurance benefits for the Product and eligibility for assistance through manufacturer co-pay, charitable foundations or manufacturer Patient Assistance Programs (PAP).

 

1.5.                Patient and Caregiver Education and Counseling.  Pharmacy shall provider patient and/or caregiver initial education on the product, how it relates to their disease, and any other services provided by the manufacturer.  Pharmacy shall have on-call pharmacists available twenty-four (24) hours per day, seven (7) days per week for any patient or caregiver questions.

 

1.6.                Shipment of Product.  Pharmacy shall label all product on a patient specific manner and ship product directly to provider, at the DEA address denoted by provider on the Order Form, who will be administering the product.  Tracking of product from pharmacy to implant location will be monitored.

 

1.7.                Re-Implant Reminders.  Pharmacy shall call patient [***] prior to implant removal / insertion to remind patient to schedule a new appointment with the provider for this service.  Will attempt to reach patient [***].  If unable to reach patient after [***], will notify prescriber.

 

1.8.                First Level Appeal Support.  Where a PA is denied for any reason other than missing or incorrect information, Pharmacy will provide first level appeal support services as part of Core Services:

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

1.8.1.                  Pharmacy will call the patient and prescriber’s office to determine whether patient and/or physician (as appropriate) wants to appeal the denied PA.

 

1.8.1.1.                    If answer is no the pharmacy will take no further action

 

1.8.1.2.                    If answer is yes, the pharmacy will assist in the following activities to support the appeal:

 

1.8.1.2.1.          Pharmacy will assist in assembling paperwork necessary to support the appeal, including, as needed, conducting daily follow-up with the physician via fax or live phone call and/or the patient via live phone call, text or email to obtain additional information as needed, and will submit the appeal to the payer (or to the physician office if there is a mandatory direct office submission requirement by the payer).

 

1.8.1.3.                    Pharmacy will conduct weekly appeal status live phone call(s) as needed with the payer to confirm approval or denial of the appeal, and if appeal is denied, obtain appropriate denial code, contact number, name of person spoken to, or other relevant information.  In the event the payer requires mandatory direct office submission, the pharmacy will [***].

 

2.              Enhanced Services

 

2.1                   Training Coordination.  In the event, a prescriber is not a Certified Prescriber, Pharmacy shall notify Manufacturer and shall not dispense to such prescriber unless the prescriber becomes a Certified Prescriber.

 

2.3                   Account Management.  Pharmacy shall [***].

 

2.4                   Data Capture and Reporting.  Pharmacy shall (a) collect the data and information set forth on Exhibit F, (b) build, test and implement data reports as required by Manufacturer and (c) provide such data reports to Manufacturer, in each case ((a)-(c)) in accordance with the data exhibits and reporting requirements outlined in Exhibit F.  Notwithstanding the foregoing, Pharmacy shall also provide, upon request by Manufacturer, Distributor or their designees, any such additional information as is necessary to comply with any FDA requests, including those requests related to the Product’s REMS Program.

 

2.5                   Implementation Fee.  Pharmacy shall develop program specific SOP’s and train all staff involved in the management of the Program.

 

Adverse Event and Product Complaint Reporting Per Manufacturer Protocol.  Pharmacy shall report any suspected adverse reactions, adverse events or Product complaints via ProPharma by phone at 844-859-6341.  This should be done as a “warm transfer.” In the event that the call is “dropped,” an email can be sent to drugsafety@propharma.com in addition to calling directly with the reporter’s complete contact information.

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

2.6                   Implant Procedure Verification.  As an additional service to the Product insurance verification, Pharmacy will obtain verification from the patient’s insurance for the implant procedure and communicate that to the prescriber of record.  The parties agree that the fee identified below for implant procedure verification shall remain subject to good faith negotiation and adjustment, in writing, if Manufacturer presents adequate evidence to Pharmacy that the fee is outside the scope of fair market value.

 

3.              Fees for Enhanced Services.  Manufacturer shall pay Pharmacy the Fees as set forth below.  The Parties agree and acknowledge that in accordance with the “Refill Reminder Exception” to the definition of “Marketing” under the HIPAA Regulations, in order for Pharmacy to receive the fair market value for certain Services that involve the use or disclosure of PHI, Pharmacy must obtain a valid HIPAA authorization from the patient permitting such use and acknowledging Pharmacy’s receipt of payment for the Services.  If Pharmacy does not receive such authorization, the Fees shall be no more than the direct and indirect cost of providing the Services.

 

	
Enhanced Service
    	
 
    	
Enhanced Service
   Fee
    	
 
    	
Frequency
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

EXHIBIT E

 

SPP RETURN GOODS POLICY

 

Effective Date: May 27, 2016

 

This Return Goods Policy is for all Products (“Product” or “Products”) commercially distributed in the United States by Braeburn Pharmaceuticals, Inc. (“Braeburn”) or Braeburn’s authorized distributor of record (collectively, “Seller”)..

 

Returned Goods Eligible for Reimbursement

 

Product shipped by Seller that is damaged in transit, subject to contracted F.O.B. terms, (i) if reported to Seller within [***] business days of receipt and (ii) returned within [***] calendar days of receipt are returnable by Customers for credit.

 

Procedure for Returning Items

 

All returnable products must be returned to Seller’s approved return goods service contractor in accordance with the contractor’s procedures and DEA guidelines.  To request a Return Authorization (RA) please contact Customer Service via phone: 844-859-6341, fax: 866-441-4091 or email: BraeburnAccess@rxcrossroads.com.

 

Customers can also initiate an RA via mail, at the following address:

 

RxCrossroads
 Attn: Braeburn Pharmaceuticals Customer Service
 4500 Progress Blvd.
 Louisville, KY 40218

 

Return Goods Credit / Valuation of Returns

 

A.            Upon approval of RA, a credit will be issued based upon the lower of the current published price at the time the returned merchandise is received by RxCrossroads or Seller’s original invoice price less cash or other discount, if any, taken by customer.

B.            Credit will be provided through credit memos only.

C.            No credit will be issued for “paper only returns.” Product must be returned for credit.

D.            Returned quantities will be audited by Return Goods Processor, and final credit will be based on Return Goods Processor’s count.

E.             All credits for the above-labeled products will be issued by Seller’s Accounting Department directly to customer’s account.

F.              Credit or reimbursement will not be issued for product destroyed by Customers or third parties.

G.            Seller is not responsible for return shipments lost in transit or received in damaged condition.

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

EXHIBIT F

 

DATA REPORTING REQUIREMENTS

 

1.

 

Report 1: Daily Dispense File

 

	
 

Data No.
    	
 
    	
Data Element
   Name
    	
 
    	
Category
    	
 
    	
Data
   Type
    	
 
    	
Description
    	
 
    	
Example
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Report 2: Weekly Inventory File

 

	
Data
   No.
    	
 
    	
Data
   Element
   Name
    	
 
    	
Category
    	
 
    	
Data
   Type
    	
 
    	
Description
    	
 
    	
Example
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

EXHIBIT G

 

TERMS AND CONDITIONS FOR CO-PAY SUPPORT PROGRAM

 

[to be negotiated within 30 days of Effective Date, attached hereto, and incorporated herein]

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00265-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00265-of-00352.parquet"}]]