SECURITIES AND EXCHANGE COMMISSION
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WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT
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PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Date of Report (Date of earliest event reported): March 29, 2013
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DYAX CORP.
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(Exact Name of Registrant as Specified in Charter)
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Delaware
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000-24537
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04-3053198
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(State or Other Jurisdiction of
Incorporation) |
(Commission File Number)
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(IRS Employer Identification No.)
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55 Network Drive
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Burlington, MA 01803
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(Address of Principal Executive Offices) (Zip Code)
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(617) 225-2500
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(Registrant's telephone number, including area code)
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Not Applicable
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(Former name or former address, if changed since last report)
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o
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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o
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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o
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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o
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
Item 8.01 | Other Events. |
Item 9.01. | Financial Statements and Exhibits. |
(d) | Exhibits. | |
10.1 | Consulting Agreement by and between Dyax Corp. and Ivana Magovcevic-Liebisch, dated as of March 29, 2013. | |
10.2† | Services Agreement between Dyax Corp. and US Bioservices Corporation, dated as of November 19, 2009. | |
10.3† | Distribution Services Agreement between Dyax Corp. and ASD Specialty Healthcare Inc., dated as of November 19, 2009. | |
10.4† | Distribution Services Agreement between Dyax Corp. and Integrated Commercialization Solutions, Inc., dated as of November 19, 2009. | |
† Pursuant to a request for confidential treatment, portions of the exhibit have been redacted from the publicly filed document and have been furnished separately to the SEC as required by Rule 406 under the Securities Act. |
DYAX CORP. | |||
Dated: | March 29, 2013 | By: | /s/Gustav Christensen |
Gustav Christensen | |||
Chief Executive Officer and President |
Exhibit No. | Description | |
10.1 | Consulting Agreement by and between Dyax Corp. and Ivana Magovcevic-Liebisch, dated as of March 29, 2013. | |
10.2† | Services Agreement between Dyax Corp. and US Bioservices Corporation, dated as of November 19, 2009. | |
10.3† | Distribution Services Agreement between Dyax Corp. and ASD Specialty Healthcare Inc., dated as of November 19, 2009. | |
10.4† | Distribution Services Agreement between Dyax Corp. and Integrated Commercialization Solutions, Inc., dated as of November 19, 2009. | |
† Pursuant to a request for confidential treatment, portions of the exhibit have been redacted from the publicly filed document and have been furnished separately to the SEC as required by Rule 406 under the Securities Act. |
1.
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Consulting Services. From and after the Termination Date, Consultant shall provide up to eight (8) hours per calendar month of consulting services upon Dyax's request and at times that are reasonably convenient for both parties. Such consulting services shall be related to:
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·
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Dyax's historical and ongoing commercial activities;
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·
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Dyax's historical and ongoing business development and licensing activities; and
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·
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Dyax's historical and ongoing legal and intellectual property activities;
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2.
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Consulting Fee. No consulting fee will be due from Dyax to Consultant for the Consulting Services. In lieu of any such fee, Dyax will (i) allow those Dyax stock options listed on Exhibit A (the "Option Exchange Options") to continue to vest during the term of this Agreement, and (ii) extend the period in which Consultant may exercise the Option Exchange Options and the vested portion of any other Dyax stock options granted to Consultant during the term of her employment with Dyax and listed on Exhibit A (the "Vested Stock Options") so that the Option Exchange Options and the Vested Stock Options will remain exercisable until the earlier of:
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(a)
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thirty (30) days after Consultant's receipt written of notice from Dyax of an alleged breach of this Agreement, provided that such breach remains uncured during such thirty (30) day period; or
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(b)
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the second anniversary of the expiration of the Term of this Agreement;
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3.
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Change in Control. In the event of a Change in Control of Dyax during the Term of this Agreement, all of Consultant’s unvested Option Exchange Options and unvested Vested Stock Options as of the date of such Change in Control shall become immediately exercisable and remain exercisable for the time period set forth in Section 2 above. For purposes of this Agreement, a Change of Control shall mean an event or occurrence set forth in any one or more of subsections (a) through (d) below:
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(a)
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any "person," as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act") (other than the Company, any trustee or other fiduciary holding securities under an employee benefit plan of the Company, or any corporation owned directly or indirectly by the stockholders of the Company in substantially the same proportion as their ownership of stock in the Company) is or becomes the "beneficial owner" (as defined in Rule 13d-3 under the Exchange Act), directly or indirectly (other than as a result of acquisitions of such securities from the Company), of securities of the Company representing fifty percent (50%) or more of the combined voting power of the Company's then outstanding securities entitled to vote generally in the election of directors;
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(b)
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individuals who, as of the date hereof, constitute the Board (the "Incumbent Board") cease for any reason to constitute at least a majority of the Board, provided that any person becoming a director subsequent to the date hereof whose election, or nomination for election by the Company's stockholders, was approved by a vote of at least a majority of the directors then comprising the Incumbent Board (other than an election or nomination of an individual whose initial assumption of office is in connection with an actual or threatened election contest relating to the election of directors of the Company) shall be, for purposes of this Agreement, considered to be a member of the Incumbent Board;
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(c)
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the consummation of a merger, share exchange or consolidation of the Company or any subsidiary of the Company with any other entity (each a "Business Combination"), other than (A) a Business Combination that would result in the voting securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of another entity) beneficial ownership, directly or indirectly, of a majority of the combined voting power of the Company or the surviving entity (including any person that, as a result of such transaction, owns all or substantially all of the Company's assets either directly or through one or more subsidiaries) outstanding immediately after such Business Combination or (B) a merger, share exchange or consolidation effected to implement a recapitalization of the Company (or similar transaction) in which no "person" (as defined above) is or becomes the beneficial owner of fifty percent (50%) or more of the combined voting power of the Company's then outstanding securities; or
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(d)
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the stockholders of the Company approve (A) a plan of complete liquidation of the Company; or (B) an agreement for the sale or disposition by the Company of all or substantially all of the Company's assets but excluding a sale or spin-off of a product line, business unit or line of business of the Company if the remaining business is significant as determined by the Company's board of directors in its sole discretion.
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4.
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Expenses. Dyax will reimburse Consultant for all pre-authorized out-of-pocket expenses reasonably incurred by Consultant in connection with the Consulting Services. Consultant shall provide Dyax with monthly invoices detailing any expenses subject to reimbursement by Dyax (which shall be itemized and accompanied by actual bills, receipts, or other evidence of expenses). Invoices will be payable by Dyax within thirty (30) days of receipt.
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5.
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Benefits. Except as expressly stated herein, Consultant shall not be entitled to participate in, or receive benefits under, any of Dyax's employee benefit plans or arrangements.
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6.
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Limitation on Authority of Consultant. Notwithstanding anything contained in this Agreement to the contrary, neither Consultant nor any employee of Consultant shall be authorized to take any action on behalf of Dyax without Dyax's prior written consent.
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7.
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Independent Contractor. At all times during the term of this Agreement, Consultant is and shall be an independent contractor in providing the Consulting Services hereunder. Except as expressly set forth herein, this Agreement shall not be deemed or construed to create a partnership or joint venture, to create the relationships of employee/employer or principal/agent, or otherwise create any liability whatsoever of either party with respect to the indebtedness, liabilities, obligations or actions of the other party or any of their employees or agents, or any other person or entity.
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8.
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Competition and Solicitation.
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(a) | During the term of this Agreement, Consultant shall not, without Dyax's prior written consent, directly or indirectly, as principal, employee, consultant, partner or stockholder of, or in any capacity with, any business enterprise (other than as a holder of not more than 1% of the combined voting power of the outstanding stock of a publicly held company): |
(i) | develop, design, produce, market, sell or render (or assist any other person or entity in developing, designing, producing, marketing, selling or rendering) any product, process or service which is identical to, substantially the same as, or an adequate substitute for any product, process or service of Dyax in existence or under development as of the Effective Date of this Agreement and on which Consultant worked or about which Consultant acquired Confidential Information; (ii) solicit or divert any of the business being conducted by Dyax; or (iii) solicit or divert any business that Consultant affirmatively knows by virtue of this Agreement is being actively pursued by Dyax with any customer or partner. |
(b) |
Until April 1, 2014, Consultant shall not, directly or indirectly solicit, take away or hire any employees or exclusive consultants of Dyax.
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(c) |
For the avoidance of doubt, the parties acknowledge and agree that it shall not be a breach of this Agreement or any other agreement between Dyax and Consultant for Consultant to accept employment with Teva Pharmaceutical Industries, Ltd. (“Teva”) effective April 1, 2013, or for Consultant to solicit and/or hire her former assistant, Mary Brunco.
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9.
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Intellectual Property. Consultant shall promptly and fully disclose to Dyax any and all inventions, improvements, discoveries, developments, original works of authorship, trade secrets, or other intellectual property (whether or not reduced to practice and whether or not protectable under state, federal or foreign patent, copyright, trade secrecy or similar laws) conceived, developed or reduced to practice by Consultant in connection with the performance of the Consulting Services or resulting from the Confidential Information acquired or generated by Consultant ("Intellectual Property"). Consultant agrees to assign, and does hereby assign, to Dyax and its successors and assigns, without further consideration, the entire right, title and interest in and to the Intellectual Property. Consultant further agrees to execute all applications for patents and/or copyrights, domestic or foreign, assignments and other papers necessary to secure and enforce rights related to such Intellectual Property. The parties acknowledge that all original works of authorship which are made by Consultant within the scope of the Consulting Services and which are protectable by copyrights are "works made for hire," as that term is defined in the United States Copyright Act (17 USCA 101).
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10.
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Confidential Information. Dyax and Consultant agree that the Confidentiality Agreement, dated January 2, 2001 executed in connection with Consultant's employment by Dyax (the "Confidentiality Agreement", a copy of which is appended hereto), is in full force and effect and that the obligations of Consultant under the Consulting Agreement shall also be deemed to be obligations of Consultant under this Agreement. As used herein the term "Confidential Information" shall have the meaning given to it under the Confidentiality Agreement.
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11.
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Injunctive Relief. The parties hereto recognize that, if Consultant fails or refuses to perform any obligations under Sections 8, 9 or 10 above, the remedy at law for such failure or refusal may be inadequate. Accordingly, in addition to any other remedies available, Consultant hereby acknowledges and agrees that Company shall be entitled to seek injunctive relief in order to ensure compliance with Sections 8, 9 or 10.
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12.
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Other Obligations. Consultant represents and warrants that Consultant is not presently under a contractual obligation or other restriction which is inconsistent with Consultant’s execution of this Agreement or the performance of the Consulting Services, and during the term of this Agreement, Consultant will not enter into any agreement, either written or oral, which conflicts with this Agreement or limits the ability of Consultant to furnish the Consulting Services in any way. Dyax acknowledges and agrees that during the Term of this Agreement, Consultant will be employed by Teva.
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13.
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Term and Termination.
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(a)
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The term of this Agreement shall commence on the Effective Date and, unless earlier terminated in accordance with Section 13(b) below, shall continue until April 1, 2015 (the "Term").
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(b)
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Furthermore, in the event of a material breach or default by a party, the other party can terminate this Agreement by giving the defaulting party forty-five (45) days prior written notice, unless the defaulting party has cured the relevant breach within such forty-five (45) day period. In the event of any termination under this Section 11(b), Dyax shall be obligated to reimburse Consultant any expenses incurred in accordance with Section 4 above. For the avoidance of doubt, any options that vested prior to such termination shall remain exercisable for ninety (90) days following such termination.
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(c)
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Termination shall not relieve Consultant of obligations pursuant to Sections 8, 9 and 10 of this Agreement.
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14.
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Governing Law. This Agreement shall be governed in all respects, including construction, validity, terms, performance and waiver, by the laws of the Commonwealth of Massachusetts without giving effect to the conflicts of laws rules therefor. Both parties agree to submit to jurisdiction in Massachusetts and further agree that any cause of action arising under this Agreement may be brought in a court in Suffolk County, Massachusetts.
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15.
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Notices. Any notice or other communication required or which may be given hereunder shall be in writing and either be personally delivered or be mailed, certified, registered or overnight mail, postage prepaid and shall be deemed given when or so delivered or, if mailed, 72 hours after the time of such mailing, as follows:
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If to Consultant: | If to Dyax: |
Ivana Magovcevic-Liebisch
208 Collins Road
Waban, MA 02468
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Dyax Corp.
55 Network Drive
Burlington, MA 01803
Attention: Chief Executive Officer
Attention: General Counsel
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16.
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Use of Names. Except as may be required to comply with any local, state or federal law or regulations, Consultant shall not release any information relative to the terms of this Agreement or the Consulting Services performed hereunder without the prior written consent of Dyax. In addition, Dyax shall not use the name of Consultant in any advertising or other form of publicity without the prior written consent of Consultant. Notwithstanding the foregoing, it shall not be a breach of this Section 16 for Consultant to generally inform Teva of the existence of this Agreement and her general obligations to Dyax hereunder.
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17.
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Successors: Assignment. This Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective heirs, successors and assigns provided however, neither Consultant nor Dyax may assign this Agreement without the prior written consent of the other party which may be reasonably withheld in the sole discretion of such party.
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18.
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Amendment: Waiver. No modification or amendment hereof shall be valid and binding, unless it be in writing and signed by the parties hereto. The waiver of any provisions hereof shall be effective only if in writing and signed by the parties hereto, and then only in specific instance and for the particular purpose for which it was given. No failure to exercise, and no delay in exercising, any right or power hereunder shall operate as waiver thereof.
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19.
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Entire Agreement. This Agreement constitutes the entire agreement of the parties with regard to the subject matter hereof and supersedes all previous written or oral representations, agreements and understandings between Dyax and Consultant, including, without limitation, the Executive Retention Agreement between Dyax and Consultant dated December 22, 2010.
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IVANA MAGOVCEVIC-LIEBISCH: | DYAX CORP. | |
By: Gustav Christensen | ||
/s/Ivana Magovcevic-Liebisch | /s/Gustav Christensen | |
Signature |
Signature
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1.1
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“Affiliate” shall mean any individual, corporation, partnership, association, or business that directly or indirectly through intermediaries, controls, is controlled by or is under common control with, a party. An ownership, voting or similar interest (including any right or option to obtain such an interest) representing more than 50% of the total interests then outstanding of the pertinent entity shall constitute “control” for the purposes of this definition.
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1.2
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“Applicable Laws” shall mean all applicable laws, rules, regulations in the Territory, including guidelines and guidances promulgated by governmental entities.
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1.3
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“Competing Product” shall mean any pharmaceutical product, other than the Product, that is being developed, manufactured or commercialized for use as a therapeutic or prophylactic treatment for Patients.
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1.4
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“FDA” shall mean the United States Food and Drug Administration or any successor agency thereto.
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1.5
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“Field” shall mean all uses in the therapeutic treatment of HAE.
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1.6
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“HIPAA” shall mean the Health Insurance Portability and Accountability Act of 1996, as amended, 42 U.S.C. § 1320d, et seq., and the implementing regulations promulgated thereunder.
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1.7
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“Hub Services” shall have the meaning set forth in Section 8.1 below.
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1.8
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“Patient” shall mean any person diagnosed with HAE.
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1.9
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“Product” shall mean Dyax’s proprietary plasma kallikrein inhibitor, known as internally as DX-88 and generically as ecallantide, as more formally described on Exhibit A.
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1.10
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“REMS Program” shall mean the Risk Evaluation and Mitigation Program required to be implemented under Section 505-1 of the Federal Food, Drug and Cosmetic Act in connection with the regulatory approval of the Product by the FDA.
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1.11
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“SOPs” shall have the meaning set forth in Section 8.4.
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1.12
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“Specialty Pharmacy Customers” shall mean health-care providers (generally physicians and physician-operated clinics) who receive Product on behalf of specific Patients pursuant to a physician-issued prescription in accordance with the terms and conditions set forth in this Agreement. For the avoidance of doubt, Specialty Pharmacy Customer shall not include specialty pharmacies, distributors, wholesalers or hospital, institutional or other pharmacies.
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1.13
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“Statement of Work” shall have the meaning set forth in Section 8.1.
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1.14
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“Term” shall have the meaning set forth in Section 15.1.
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1.15
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“Territory” shall mean the 50 states of the United States of America, the District of Columbia and Puerto Rico.
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2.
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Engagement of US Bio.
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2.1
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Engagement. Upon the terms and conditions set forth herein, Dyax hereby engages US Bio, on an exclusive basis during the Term (subject to Section 15.4), to (i) dispense and distribute Product to Specialty Pharmacy Customers for the Field in the Territory, and (ii) provide the Hub Services. US Bio hereby accepts such engagement and shall dispense and distribute Product to Specialty Pharmacy Customers in the Territory and provide the Hub Services in a professional and responsible manner and in accordance with the terms of this Agreement and all Applicable Laws.
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2.2
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Authorized Distributor. In connection with US Bio’s engagement under Section 2.1 above, and solely for the limited purpose of compliance with the pedigree requirements of the Prescription Drug Marketing Act and any similar state laws, Dyax hereby designates US Bio as an Authorized Distributor of Record (“ADR”) of the Product during the Term.
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2.3
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Exclusivity.
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(a)
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The parties acknowledge and agree that as a result of the exclusive nature of the US Bio engagement, (i) subject to Section 15.4, during the Term, Dyax shall not engage any party other than US Bio or its Affiliates to dispense and distribute Product to Specialty Pharmacy Customers for the Field in the Territory or perform the Hub Services, (ii) during the Term and for [*****] thereafter, US Bio shall not, and shall cause its Affiliates providing specialty pharmacy services not to, provide services substantially similar to the Hub Services for any Competing Product, and (iii) during the Term and for [*****] thereafter, US Bio shall not promote any Competing Product. To the extent that a non-specialty pharmacy Affiliate of US Bio provides services for a Competing Product, US Bio acknowledges that it will maintain the confidentiality and security of all Dyax Confidential Information in accordance with Article 11 and that US Bio will not disclose any Confidential Information of Dyax, or any acquired knowledge or learnings that US Bio may obtain in connection with the performance of the Hub Services, to any such Affiliate.
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(b)
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The parties acknowledge and agree that the restriction set forth in Section 2.3(a)(iii) shall not preclude US Bio from (i) dispensing a Competing Product, (ii) providing clinically appropriate information to healthcare providers, patients and others in connection with dispensing a Competing Product, or (iii) providing general information on US Bio’s specialty pharmacy services; provided that, in each case US Bio does not violate the terms of this Agreement or otherwise Disadvantage the Product in any way in the Territory. For purpose of the foregoing sentence, “Disadvantage” shall mean any activities that (X) are intended to encourage, or could reasonably be foreseen to encourage, the utilization of a Competing Product, such as advertising the Product in a manner that suggests that a Competitive Product is superior to the Product in terms of acquisition price, reimbursement rates, or efficacy, or (Y) otherwise operate to the disadvantage of the Product.
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2.4
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Reserved Rights.
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(a)
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Except as expressly provided in this Agreement, no right, title or interest in or to Product or any patent, trade secret, trademark or any other intellectual property right of Dyax or its Affiliates is granted, whether express or implied, by Dyax to US Bio. In furtherance of the foregoing and not in limitation thereof, nothing herein shall in any way limit Dyax’s ability to (i) dispense or distribute Product to Specialty Pharmacy Customers outside of the Territory, (ii) dispense or distribute Product to Specialty Pharmacy Customers in the Territory for uses outside the Field or (iii) dispense or distribute Product to any person or entity other than a Specialty Pharmacy Customer, including specialty pharmacies, distributors, wholesalers or hospital pharmacies or health-care providers that purchase Product on a wholesale basis (e.g., buy-and-bill or consignment).
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(b)
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Except as expressly provided in this Agreement, no right, title or interest in or to any patent, trade secret, trademark or any other intellectual property right of US Bio or its Affiliates is granted, whether express or implied, by US Bio to Dyax. By way of clarification, all proprietary systems, databases and web-based applications, and any standard operating procedures, work rules, programming, software, routines, analytic tools, embedded logic or table structures associated therewith, that have been developed, maintained, utilized and improved by US Bio (or its Affiliates) in connection with this Agreement or the Hub Services are and will remain the property of US Bio (or its Affiliates).
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2.5
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Service Level Commitments. The parties to this Agreement desire to define a mutually beneficial relationship between Dyax and US Bio in order to achieve Dyax’s goals of high patient level product availability, high levels of consumer and pharmacy confidence in the integrity and quality of the Product, and achievement of a collaborative, transparent, and cost-effective distribution system. In order to achieve the stated goals, US Bio agrees to dispense and distribute the Product and perform the Hub Services hereunder in accordance with the key performance indicators described in the Statement of Work attached hereto as Exhibit B and incorporated herein by this reference.
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3.
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Purchase and Sale of Product.
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3.1
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Purchase of Product. US Bio shall (i) purchase Product only from Dyax (or its third party logistics provider acting on Dyax’s behalf) and no other supplier, (ii) dispense and distribute Product that it has purchased from Dyax, and (iii) dispense and distribute Product only to Specialty Pharmacy Customers for the Field in the Territory. US Bio shall fill orders for Product only with Product and shall not substitute other products.
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(a)
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The price payable by US Bio to Dyax for all Product purchased by US Bio hereunder (the “Purchase Price”) shall be [*****].
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(b)
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Dyax promptly shall invoice US Bio for the Purchase Price for all Product purchased hereunder. All Dyax invoices for Product shall be due and payable by US Bio within [*****] after receipt by US Bio [*****]. On all undisputed balances exceeding [*****] from invoice receipt, US Bio shall pay interest equal to the lesser of (i) [*****] per month and (ii) the maximum allowed by law.
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4.
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Delivery of Product to US Bio.
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4.1
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Product Orders. US Bio shall submit all Product orders electronically in the industry standard format in accordance with such procedures as may be mutually agreed upon by the parties. Unless otherwise agreed between the parties, all Product orders shall be submitted in quantities of 20 units (or multiples of 20 units).
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4.2
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Delivery Times. Dyax shall make commercially reasonable efforts to ship all US Bio orders completely and to have Product from such orders shipped to US Bio within a mutually agreeable schedule of up to [*****] of order placement. US Bio acknowledges and agrees that Dyax may not be able to fill all orders completely or within a specified time due to shortages or other causes and such inability shall not constitute a breach of this Agreement.
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4.3
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Product Dating. Dyax shall ship Product to US Bio with at least [*****] shelf life remaining, unless otherwise agreed in writing (including via email or other electronic communication) by US Bio. [*****]
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4.4
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Product Delivery; Risk of Loss. Dyax shall deliver all Product Free On Board to US Bio’s facility in the Territory designated in the applicable order. For purposes of this Section, the term “Free On Board” means that Dyax shall (i) bear all costs associated with shipping Product to the US Bio designated facility, and (ii) bear all risk of loss for Product until its delivery to the designated US Bio facility. Title to, and risk of loss of, all Product shall pass to US Bio on delivery.
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4.5
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Inspection of Product. US Bio shall examine the Product upon delivery at US Bio’s designated facility and shall notify Dyax in writing (including via email or other electronic communication) within one (1) business day of any problems relating to the quantity of Product delivered or any defect in any of the Product that is reasonably discoverable upon visual inspection of the Product without unpacking of pallets.
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4.6
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No Alteration. US Bio shall not alter the Product in any way, including the packaging thereof, without Dyax’s written consent (except to remove the Product from the shipping containers) and shall not alter the Product labeling, except to add a prescription label to the Product upon dispensing or shipment, as required by Applicable Laws.
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4.7
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Storage Conditions. US Bio will maintain Product stored at, and shipped from, its facilities under (i) the Product storage, shipment and handling requirements set forth in the FDA-approved labeling and (ii) any additional requirements mutually agreed upon between US Bio and Dyax. US Bio shall notify Dyax within one (1) business day of any deviation from such requirements so that Dyax can determine whether any further action must be taken with respect to such Product. Failure of US Bio to notify Dyax promptly of such deviation shall constitute a breach of this Agreement by US Bio.
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5.
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Product Inventories.
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5.1
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Inventory Levels. During the Term, unless otherwise agreed to by Dyax in writing (including via email or other electronic communication) and subject to Section 5.2, US Bio shall maintain at all times an inventory of Product in an amount equal to not less than [*****] nor more than [*****] of [*****].
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5.2
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Supply Shortages. US Bio shall have no obligation to maintain the minimum inventory levels described in Section 5.1 if Product is unavailable from Dyax.
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6.
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Product Returns.
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7.
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Suspension, Recalls and Government Notices.
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7.1
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Suspension. Upon written notification by Dyax to suspend distribution of Product, US Bio immediately shall suspend its distribution of Product. If the suspension continues for more than [*****], Dyax will repurchase Product in saleable condition held in inventory by US Bio at the price paid for such Product by US Bio. All repurchased Product shall be returned to Dyax (or Dyax’s third party logistics provider) at Dyax’s expense.
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7.2
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Recalls.
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(a)
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Recalls Procedures. Dyax shall promptly notify US Bio of any recalls or market withdrawals initiated by Dyax or required by the FDA or any other governmental agency. US Bio shall notify Dyax immediately of any event or circumstance that US Bio reasonably believes may necessitate a recall or market withdrawal. Upon receipt of notice of a recall or market withdrawal from Dyax, US Bio shall administer such recall or market withdrawal under the direction of Dyax, including promptly notifying the affected Specialty Pharmacy Customers of US Bio in accordance with Dyax’s instructions. Dyax shall provide US Bio with a form letter to be used in connection with notice of any recall or market withdrawal, and shall, to the extent practicable, provide US Bio the opportunity to review and comment on such letter. Dyax shall be responsible for the mailing, shipping, and reasonable administrative expenses incurred by US Bio in connection with the recall or market withdrawal, plus a reasonable service fee as mutually agreed upon in advance by the parties as well as the cost of replacement Product for US Bio’s Specialty Pharmacy Customers. Notwithstanding the foregoing, to the extent that such recall or market withdrawal arises or results from (i) the negligence or intentional misconduct of US Bio or any of its permitted agents or employees or (ii) the breach by US Bio of this Agreement, US Bio shall bear and be responsible for all such costs as well as the reasonable, documented, out-of-pocket expenses of Dyax incurred in connection with such recall or market withdrawal.
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(b)
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Investigations; Cooperation. US Bio shall reasonably cooperate with Dyax in investigating any Product failure that resulted in the need for a recall or market withdrawal and any reasonable, documented, out-of-pocket cost involved with such investigation shall be reimbursed by Dyax, except to the extent that such recall or market withdrawal arises or results from (i) the negligence or intentional misconduct of US Bio or any of its permitted agents or employees or (ii) the breach by US Bio of this Agreement, in which event US Bio shall bear and be responsible for such costs as well as the reasonable, documented, out-of-pocket expenses of Dyax incurred in connection with such investigation.
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7.3
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Government Notices. Each party shall provide the other with a copy of any correspondence or notices it receives from the FDA, or other governmental entity specifically relating to activities conducted under this Agreement, no later than one (1) business day following such receipt. In addition, US Bio shall provide Dyax with any notice it receives from the FDA or other governmental entity relating to Product no later than one (1) business day following such receipt. Each party shall also provide the other with concurrent copies of any responses to any such correspondence or notices (e.g., a response to an FDA 483 notice, warning letter, or untitled regulatory letter); provided that Dyax shall review and approve all such responses by US Bio to the extent related to the Product and to the extent reasonably feasible. Where reasonably possible, US Bio shall give prior notice to Dyax of any scheduled FDA or other governmental inspection of US Bio’s facilities specifically relating to the Product, and, if reasonably possible, will afford Dyax the opportunity to be present at such inspection.
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8.
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Hub Services and Related US Bio Obligations.
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8.1
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Hub Services; Statement of Work. US Bio shall provide certain support services relating to (i) the sale and use of the Product in the Field in the Territory and (ii) the REMS Program (collectively, the “Hub Services”). The specific nature of such Hub Services, and any additional terms and conditions applicable to such Hub Services, shall be set forth in writing (each such writing, a “Statement of Work”). The initial Statement of Work that has been agreed upon by the parties is attached hereto as Exhibit B. Any changes to the initial Statement of Work or any new Statement of Work must be in writing and approved by both parties, and thereafter shall be considered an addendum to this Agreement. All Services performed under any Statement of Work shall be subject to all the terms and conditions set forth herein.
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8.2
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REMS Program. US Bio shall distribute Product, perform the Hub Services, and otherwise conduct all activities under this Agreement in accordance with the REMS Program and any additional policies Dyax implements and provides in writing to US Bio. Without limiting the scope of the foregoing, US Bio agrees that any promotional, educational or other materials delivered to Specialty Pharmacy Customers and/or Patients in connection with this Agreement shall be preceded or accompanied by the medication guide, the healthcare provider letter and/or any other materials required by the REMS Program, as applicable, and in accordance with the provisions of the REMS Program.
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8.3
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Adverse Event Reporting. In the event that an adverse experience, as that term is defined at 21 C.F.R. § 600.80 (as such provision may be amended from time to time), with regard to the Product is reported to US Bio, US Bio shall ensure that all applicable safety and other relevant information relating to the Product that is obtained during the course of any interaction with patients, healthcare providers, or other individual, is communicated and maintained in accordance with Applicable Laws. US Bio shall notify Dyax of any adverse drug experiences with regard to the Product within three (3) business days after its first receipt; provided however, that any information relating to a serious adverse experience (SAE), as that term is defined at 21 C.F.R. § 600.80 (as such provision may be amended from time to time), shall be provided to Dyax within one (1) business day after its first receipt. US Bio shall also make all reasonable efforts to assist Dyax with any follow-up investigation necessary to comply with Applicable Laws with respect the reporting of adverse drug experiences relating to the Product; provided, that US Bio will not be responsible for reporting of any adverse events to the FDA. Dyax and US Bio will ensure that appropriate SOPs (as defined in Section 8.4) regarding adverse experiences are established, maintained and regularly reviewed to ensure compliance in accordance with the terms of this Agreement and Applicable Laws. Dyax and US Bio will ensure that all staff involved in these activities are appropriately trained and records of such training are maintained.
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8.4
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Standard Operating Procedures; Other Work Instructions. US Bio shall conduct all Hub Services under this Agreement in accordance with Standard Operating Procedures (“SOPs”) and other Dyax-specific work instructions (“Dyax Instructions”) applicable to such activities, as established and approved in writing by the parties from time to time. The preliminary SOPs and Dyax Instructions that have been approved by the parties are attached hereto as Exhibit C. [*****] The parties acknowledge and agree that the Hub Services SOPs and Dyax Instructions are the property of Dyax and to the extent that such Hub Services SOPs and Dyax Instructions are maintained by US Bio, then, upon termination or expiration of this Agreement or otherwise upon Dyax’s request, US Bio will deliver such SOPs and Dyax Instructions to Dyax. Notwithstanding anything to the contrary contained in this Agreement or elsewhere, during the Term of this Agreement, the SOPs shall not include any of US Bio’s internal standard operating procedures or work instructions that are non-specific to Dyax and the Product, which are the confidential and proprietary property of US Bio and shall not be disclosed by Dyax to any third party without the consent of US Bio. Dyax shall be permitted, upon its reasonable request, to review any of US Bio’s internal standard operating procedures or work instructions at US Bio’s facility. Upon termination of this Agreement, any of US Bio’s internal standard operating procedures or work instructions in Dyax’s possession will be returned to US Bio or (at US Bio’s election) destroyed by Dyax, with Dyax providing US Bio with a written certification of destruction.
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8.5
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No Subcontracting or Subdistribution. All obligations and services to be performed by US Bio under this Agreement shall be solely performed by US Bio and US Bio shall not outsource or subcontract any of its obligations hereunder without Dyax’s prior written consent.
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8.6
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Applicable Laws and Regulations. US Bio shall conduct all activities under this Agreement in compliance with all Applicable Laws, including federal and state pharmacy or pedigree laws, laws relating to the promotion of prescription medicines including the prohibition of off-label promotion, federal and state laws protecting the privacy of patient or prescriber identifiable information (including HIPAA), federal and state anti-kickback laws and regulations, laws relating to the disposal of pharmaceutical products and hazardous wastes, and all applicable professional and industry standards and good business practices. If Dyax reasonably determines that US Bio has conducted activities under this Agreement in a manner that could potentially compromise public health or safety, then Dyax may terminate this Agreement immediately, and whether or not Dyax terminates this Agreement, may pursue all other legal remedies available to it.
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8.7
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Product Promotion. US Bio will not provide any information regarding the safety, effectiveness, or use of Product to Specialty Pharmacy Customers or other persons or entities except as approved in advance in writing by Dyax or required by Applicable Laws. US Bio may provide information on its own specialty pharmacy and distribution services to its Specialty Pharmacy Customers in accordance with US Bio standard business practices, including informing its Specialty Pharmacy Customers of pricing available for the Product and other products distributed by US Bio. US Bio warrants that any information it provides to its Specialty Pharmacy Customers regarding Product or its services will be truthful and non-misleading and will comply with all Applicable Laws.
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8.8
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Discounts. To the extent required by Applicable Laws, including 42 U.S.C. §§ 1320a-7b(b) and in conformance with the standards set forth in 42 C.F.R. § 1001.952(h) for safe harbor protection, US Bio shall advise and inform each of its Specialty Pharmacy Customers to fully report, as required by law or contract, any discounts, rebates, or reductions in prices on Product and provide the discount information supplied by US Bio to the Department of Health and Human Services or a state agency upon request, consistent with the requirements of 42 U.S.C. § 1320a-7b(b) and 42 C.F.R. § 1001.952(h).
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8.9
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Diversion. US Bio shall notify Dyax in writing (including via email or other electronic communication) promptly within one (1) business day of learning of information to suggest that any person or entity is diverting or attempting to divert Product. For the purposes of this Section 8.9, “diverting” means the unauthorized sale, distribution, purchase, receipt, or handling of Product. Dyax may immediately terminate this Agreement upon written notice if it is determined by Dyax that US Bio has purchased Product from sources other than Dyax or its designated third party logistics provider.
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9.
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Compensation for Hub Services.
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10.
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Reports and Records.
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10.1
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Product Reports. US Bio shall generate and furnish to Dyax (or its designee) the Product reports specified in the Statement of Work attached as Exhibit B (collectively, the “Product Reports”).
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10.2
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Activity Reports. In addition to any specific reports that US Bio may be required to deliver to Dyax under this Agreement, US Bio shall provide to Dyax (or its designee) all information and reports related to its activities with respect to the Product that are reasonably requested by Dyax and can be prepared by US Bio without undue burden; provided, that US Bio shall be compensated and fully reimbursed by Dyax for any additional time and expense incurred in connection with the preparation and delivery of such information and/or reports.
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10.3
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Compliance. The parties intend that all reports provided to Dyax under Sections 10.1, 10.2 and 13.3 shall comply with Applicable Laws, including HIPAA and any laws relating to the identity of the Patient or prescriber. Accordingly, the parties agree that US Bio shall only provide Dyax with patient information that is de-identified in accordance with HIPAA’s de-identification provision, 45 C.F.R. § 164.514(b), unless: (i) Dyax or US Bio has on file a valid, HIPAA-compliant written authorization for each patient whose protected health information (“PHI”) is sought to be disclosed; or (ii) written authorization is not required under Applicable Laws in order to disclose the PHI sought. To the extent they may be required by HIPAA, US Bio shall obtain any Business Associate Agreements (as described in 45 C.F.R. § 164.504) that are necessary to fulfill its obligations under this Agreement. In the event of any inconsistency between the data file layouts described for the Product Reports in the Statement of Work attached as Exhibit B and this Section 10.3, the terms of this Section 10.3 shall control. In the event of any amendment to any Applicable Laws, US Bio shall be entitled to unilaterally modify the data reports, without consent from Dyax, as required to comply with such amendments; provided that US Bio shall provide Dyax with notice of such modification and a description of the amendment requiring such modification prior to submitting a modified data report. In addition to the foregoing, the parties acknowledge that existing contractual relationships with third party payors may restrict US Bio’s ability to collect, use, and/or disclose certain Patient-, payor-, or physician-specific data.
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10.4
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Ownership and Use of Data. Subject to Applicable Laws, Dyax shall have the following rights with respect to information and data relating to Product, the sale of Product to Specialty Pharmacy Customers and the use by Product of Patients obtained, maintained, generated or furnished by US Bio to Dyax in connection with performing US Bio’s obligations hereunder, including such data and information contained in the reports delivered pursuant to Sections 10.1 and 10.2:
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(a)
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With respect to the activity and other data generated in connection with the Hub Services (which shall be captured in the Hub Services database and may be reported to Dyax pursuant to this Agreement), Dyax shall own and have the exclusive right to use all such information and data (provided, that US Bio may use any and all information and data to the extent required in its performance of the Hub Services or as otherwise necessary in connection with its dispensing of Product and related services to Patients) and all such information shall be deemed to be Dyax Confidential Information; and
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(b)
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The parties acknowledge and agree that US Bio shall own product dispensing data and any other clinical data related to such dispensing activities. With respect to all information and data not covered by Section 10.4(a) but which is provided by US Bio to Dyax in accordance with this Agreement, Dyax shall have a right to use any and all information and data, for any purpose as permitted by law or, to the extent such data contain PHI, as permitted by the applicable patient’s written authorization or as otherwise allowed under the law.
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10.5
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Records. US Bio shall keep complete and accurate books and records pertaining to US Bio’s activities under this Agreement. Such books and records shall be retained for at least [*****] after the expiration or termination of this Agreement or for such longer period as may be required by Applicable Laws.
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10.6
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Audits. Dyax, at its expense, from time to time may perform, or have an independent third party auditor (subject to execution of a mutually agreeable nondisclosure agreement) perform, audits of the records maintained pursuant to Section 10.5 and may observe, or have an independent third party auditor observe, the performance by US Bio of its activities hereunder to verify the status of Product and ensure compliance with the terms of this Agreement. Dyax shall provide US Bio with at least ten (10) business days advance written notice of such audits or observations, and shall conduct any audit or observation during normal business hours in a manner that does not interfere with US Bio’s normal business operations. US Bio shall make available relevant records that do not contain information pertaining to US Bio’s other clients or products and permit such observations. Dyax and US Bio shall discuss the results of any such audits or observations and US Bio shall implement all corrective measures reasonably requested by Dyax. All audits shall be reasonable in time and scope.
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11.
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Confidentiality.
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11.1
|
Confidential Information. All confidential, non-public documents and other information disclosed to a party by or on behalf of the other party pursuant to this Agreement, which includes but is not limited to information concerns prices and quantities purchased by any customer, Product information, pricing, fees and proposals, operating and sales data, information about processes, systems, strategic plans, business plans, financial information, processes (including SOPs), customer information, information concerning patients or physicians, methods, databases, technology (including software and all source code), and any analysis, compilation, or study, and any other information or materials prepared or derived from such information (collectively, “Confidential Information”), shall, subject to Sections 11.2 and 11.3, be held by the receiving party in strict confidence and not disclosed either directly or indirectly to any third party (other than Affiliates, advisors and consultants who have a need to know such information and who are subject to obligations of confidentiality at least as onerous as those set forth herein) and shall only be used for purposes of fulfilling the receiving party’s obligations, or exercising its rights, under this Agreement. Notwithstanding the foregoing, all data and information owned by Dyax pursuant to Section 10.4 shall be the Confidential Information of Dyax and not US Bio, and regardless of the party that discloses such Confidential Information hereunder, Dyax shall be deemed the disclosing party, and US Bio shall be deemed the receiving party, with respect to such Confidential Information. The terms and conditions of this Agreement and any amendments or addenda thereto shall be deemed the Confidential Information of each party.
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11.2
|
Exclusions from Confidentiality. Notwithstanding anything to the contrary in this Agreement, the receiving party shall have no liability to the disclosing party for the use or disclosure of any Confidential Information that the receiving party can establish by written documentation to:
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(a)
|
have been publicly known prior to disclosure by the disclosing party of such information to the receiving party;
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(b)
|
have become publicly known without fault on the part of the receiving party, subsequent to disclosure to the receiving party;
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(c)
|
have been received by the receiving party at any time from a source, other than the disclosing party, lawfully having possession of and the right to disclose such information;
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(d)
|
have been otherwise known by the receiving party prior to disclosure by the disclosing party to the receiving party of such information; or
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(e)
|
have been independently developed by the receiving party without use of information disclosed by the Disclosing Party.
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11.3
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Required Disclosure. A party receiving Confidential Information may disclose such Confidential Information if required to do so by a court (or other governmental agency or stock exchange of competent jurisdiction), any governmental body or as required under any Applicable Laws; provided that (i) the party required to disclose such Confidential Information provides prompt notice of such pending disclosure to the disclosing party so that the disclosing party can seek a protective order or to prevent such disclosure, and (ii) the party required to disclose such Confidential Information shall exercise reasonable efforts to ensure that the information is accorded confidential treatment by the court or other governmental agency or stock exchange.
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11.4
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Survival of Confidentiality Obligations. The provisions of this Section 11 shall survive for a period of [*****] following the expiration or termination of this Agreement.
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11.5
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Injunctive Relief. Each party acknowledges that the failure by the Receiving Party to comply with any of the provisions of this Section 11 will result in irreparable injury and continuing damage to the disclosing party for which there will be no adequate remedy at law and that, in the event of a failure of the receiving party so to comply, the disclosing party shall be entitled to seek such preliminary and permanent injunctive relief as may be necessary to ensure compliance with all the provisions of this Section without having to prove actual damages or to post a bond.
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12.
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Use of Marks.
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13.
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Additional Representations, Warranties and Covenants.
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13.1
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Authorization. Each party represents and warrants to the other party that it has the legal right and power to enter into this Agreement, to extend the rights and licenses granted to the other in this Agreement, and to fully perform its obligations hereunder, and that the performance of such obligations will not conflict with its charter documents or any agreements, contracts, or other arrangements to which it is a party. Furthermore, no approvals, consents, orders or authorizations of or designation, registration, declaration or filing with any governmental authority (within the Field in the Territory) is required for either party’s performance of its obligations under this Agreement, other than any approvals that have been obtained already or will be obtained in the ordinary course of the performance of such obligations.
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13.2
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No Other Agreements. Each party represents and warrants to the other that this Agreement is not dependent on, and does not operate in conjunction with (either explicitly or implicitly), any other arrangement between Dyax and US Bio.
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13.3
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Product Pricing. US Bio represents, warrants and covenants that:
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(a)
|
it will refrain from doing anything that would impede Dyax from meeting any reporting obligations with respect to Product pricing that Dyax may have under Applicable Laws;
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(b)
|
it will report the Product sales price offered to Specialty Pharmacy Customers on the invoices or statements submitted by US Bio to Dyax; and
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(c)
|
no discount provided or other payment made pursuant to this Agreement is intended in any way as a discount related to a drug formulary and has not been negotiated or discussed between the parties in connection with any drug formulary.
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13.4
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Hub Services; Service Fees. The parties mutually represent and warrant to each other that:
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(a)
|
the service fees paid to US Bio in connection with the Hub Services (i) are not intended in any way as remuneration for US Bio to use, purchase, or recommend any Dyax product or service, except as provided for in this Agreement, (ii) represent the fair market value for the Hub Services based upon arms length negotiations, (iii) are bona fide service fees that do not constitute a discount or other form of compensation that must be included in Dyax’s reporting of pricing information for Product to the Centers for Medicare and Medicaid Services;
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(b)
|
the service fees paid to US Bio in connection with the Hub Services are not intended in any way as payment related to a drug formulary or drug formulary activities and have not been negotiated or discussed between the parties in connection with any such drug formulary or formulary activities; and
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(c)
|
the Hub Services do not involve the counseling or promotion of a business arrangement or other activity that violates any state or federal law.
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13.5
|
Federal Programs. US Bio represents, warrants and covenants to Dyax that (a) neither US Bio nor any of its Affiliates that perform activities under this Agreement has been debarred or is subject to debarment pursuant to Section 306 of the Act or listed on either Excluded List (as defined herein), and (b) neither US Bio nor any of its Affiliates that perform activities under this Agreement will knowingly (after reasonable investigation) use in any capacity, in connection with the services to be performed under this Agreement, any person who has been debarred pursuant to Section 306 of the Act, or who is the subject of a conviction described in such section, or listed on either Excluded List. US Bio shall inform Dyax in writing immediately if it or any person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 of the Act or listed on either Excluded List, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of US Bio’s knowledge, is threatened, relating to the debarment or conviction Section 306 of the Act, or listing on either Excluded List, of US Bio or any person performing services hereunder. “Excluded Lists” means the Department of Health and Human Service’s List of Excluded Individuals/Entities and the General Services Administration’s Lists of Parties Excluded from Federal Procurement and Non-Procurement Programs.
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13.6
|
Licensure. US Bio represents and warrants that it now has and shall maintain in full force during the Term all applicable federal and state pharmacy and other licenses or approvals required under Applicable Laws and regulations to fulfill its obligations under this Agreement in each state in the Territory, the District of Columbia and Puerto Rico. US Bio promptly shall notify Dyax of any denials, revocations or suspension of license or registrations by any state or federal agency or any other regulatory authority in the Territory, or any written notice from a governmental body proposing such a denial, revocation or suspension of a license or registration. US Bio shall promptly provide Dyax with notice of any material communications with pharmacy licensing boards which relate to potential problems with facilities, operations, contractors or procedures used by US Bio in distribution of the Product, including notices of inquiries, investigations or inspections and resulting findings, except that in no event shall US Bio be required to disclose information concerning its other clients or the products of such clients.
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13.7
|
Dyax Representations and Warranties. Dyax hereby represents and warrants to US Bio that, at the time of delivery of Product by Dyax to US Bio hereunder: (a) such Product shall not in any material respect be adulterated, misbranded or otherwise prohibited within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et. seq., as amended and in effect at the time of delivery (the “Act”), or within the meaning of any applicable state or local law; (b) such Product will be merchandise that may be introduced and delivered into interstate commerce under the provisions of Section 301 of the Act or Section 351 of the Public Health Service Act; (c) Dyax (or as applicable its designated third-party logistics provider) has and will maintain, in full force and effect, all licenses and permits required under Applicable Laws for Dyax to sell and distribute such Product under this Agreement; (d) such Product will be the subject of a duly approved Biologics License Application and may be legally transported or sold under Applicable Laws; (e) such Product will have been approved by each applicable governmental authority for commercial sale and shipment of such Product within the Territory; and (f) Dyax either (i) owns or holds the duly approved Biologics License Application, as such term is used in the Public Health Service Act, Title 21, United States Code, as amended for such Product, or (ii) is otherwise considered the “manufacturer” of such Product within the meaning of any applicable federal, state or local law relating to pedigrees.
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13.8
|
No Other Warranties. Except as expressly provided herein, neither party hereto makes any representations or warranties to the other party, express or implied, either in fact or by operation of law, by statute or otherwise, and each party specifically disclaims any express or implied representations and warranties of merchantability or fitness for a particular purpose.
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14.
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Liability, Indemnification and Insurance.
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14.1
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Remedies.
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(a)
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Generally. Rights and remedies under this Agreement are cumulative and in addition to any other available rights or remedies under any other agreement, at law or in equity.
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(b)
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Equitable Relief. If either party violates or threatens to violate any provision of this Agreement, the other party may suffer irreparable harm and its remedies at law may be inadequate. Accordingly, the other party may seek equitable relief.
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14.2
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Indemnification.
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(a)
|
Indemnification by US Bio. US Bio shall indemnify, defend, and hold harmless Dyax and its Affiliates and its and their respective directors, officers, employees, representatives and agents and their respective successors, heirs and assigns (the “Dyax Indemnitees”) against any liability, damage, loss, penalty, fine or expense (including reasonable attorneys fees and expenses of litigation) (collectively, “Losses”) incurred by or imposed upon the Dyax Indemnitees or any of them in connection with any claims, suits, demands, investigations, enforcement actions, or judgments, in each case initiated by a third party (including any governmental or regulatory agency) (collectively, “Third Party Claims”) which arise out of: (a) the gross negligence or willful misconduct of US Bio in connection with this Agreement; or (b) the breach of this Agreement by US Bio, in each case except for those Losses for which Dyax has an obligation to indemnify US Bio pursuant to Section 14.2(b), as to which Losses each party shall indemnify the other to the extent of its respective liability for such Losses.
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(b)
|
Indemnification by Dyax. Dyax shall indemnify, defend, and hold harmless US Bio and its Affiliates and its and their respective directors, officers, employees, representatives and agents and their respective successors, heirs and assigns (the “US Bio Indemnitees”) against any Losses incurred by or imposed upon US Bio Indemnitees or any of them in connection with any Third Party Claims which arise out of: (a) the negligence or willful misconduct of Dyax in connection with this Agreement; (b) the breach of this Agreement by Dyax, in each case except for those Losses for which US Bio has an obligation to indemnify Dyax pursuant to Section 14.2(a); (c) any claims of patent, trademark, copyright or other infringement related to Products; or (d) the storage, handling, use, non-use, demonstration, consumption, ingestion, digestion, manufacture, production and assembly of Products and their transportation to US Bio (except to the extent that such activities are conducted on Dyax’s behalf by an Affiliate of US Bio), as to which Losses each party shall indemnify the other to the extent of its respective liability for such Losses.
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(c)
|
Indemnification Procedure. A party that intends to claim indemnification under this Section 14.2 (the “Indemnitee”) shall: (i) promptly notify the indemnifying party (the “Indemnitor”) in writing of any Third Party Claim in respect of which the Indemnitee or any of its Affiliates or any of their respective directors, officers, employees, representatives, agents or their respective successors, heirs or assigns intend to claim such indemnification hereunder; (ii) provide the Indemnitor sole control of the defense and/or settlement thereof with counsel reasonably satisfactory to the Indemnitee; provided, however, that the Indemnitee reserves the right to retain its own counsel to defend itself in, but not control the defense of, such suit, at its own expense, unless (a) the interests of the Indemnitee and the Indemnitor in the suit conflict in such a manner and to such extent as to require, consistent with applicable standards of professional responsibility, the retention of separate counsel for the Indemnitee, in which case, the Indemnitor shall pay for one separate counsel chosen by the Indemnitee or (b) the Indemnitor shall not have employed attorneys reasonably satisfactory to the Indemnitee to defend any action within a reasonable time after notice of commencement of such action and (iii) provide the Indemnitor, at the Indemnitor’s request and expense, with reasonable assistance and full information with respect thereto. Neither the Indemnitor nor the Indemnitee shall be responsible to or bound by any settlement made by the other without its prior written consent, which shall not be unreasonably withheld or delayed. Without limiting the foregoing provisions of this Section 14.2(c), the Indemnitor shall keep the Indemnitee reasonably informed of the progress of any claim, suit or action under this Section 14.2 and the Indemnitee shall have the right to participate in any such claim, suit or proceeding with counsel of its choosing at its own expense, but the Indemnitor shall have the sole right to control the defense or settlement thereof in accordance with the terms of this Section 14.2(c).
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14.3
|
Limitation of Liability.
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(a)
|
Neither party shall be liable to the other for special, exemplary, consequential, incidental (including lost or anticipated revenues or profits), indirect or punitive damages arising from the performance or nonperformance of such party under this Agreement whether such claim is based on contract, tort (including negligence) or otherwise, even if an authorized representative of such party is advised of the possibility or likelihood of same.
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(b)
|
Notwithstanding the exclusions and limitations of liability set forth in Section 14.3(a) above, such exclusions and limitations shall not apply to: (i) either party’s indemnification obligations pursuant to Section 14.2; or (ii) either party’s breach of the party’s confidentiality obligations pursuant to Article 11.
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14.4
|
US Bio Insurance Obligations. During the Term, US Bio shall maintain the following minimum levels of insurance:
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(a)
|
Employer’s liability insurance with a limit of [*****] for bodily injury by accident per person, [*****] for bodily injury by accident, all persons and [*****] bodily injury by disease policy limit;
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(b)
|
Commercial general liability insurance, including personal injury blanket contractual liability and broad form property damage, with a [*****] combined single limit;
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(c)
|
Umbrella liability insurance in the amount of [*****] per occurrence and aggregate; and
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(d)
|
Property insurance covering the business property of US Bio and others while at any unnamed location in the amount of [*****].
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14.5
|
Dyax Insurance Obligations. During the Term, Dyax will maintain products liability and commercial general liability insurance having a limit of not less than [*****] per occurrence, Combined Single Limit (Bodily Injury and Property Damage), pursuant to one or more insurance policies with reputable insurance carriers having a Best’s Rating of A VII or otherwise as reasonably approved by US Bio. Dyax will designate US Bio as an “additional insured” under such insurance policy and will obtain a broad form vendor’s endorsement for products liability for US Bio. Within thirty (30) days after the Effective Date, Dyax will provide to US Bio a certificate of insurance indicating that such obligations have been satisfied. As a condition precedent to the effectiveness of this Agreement, Dyax will execute the form of Continuing Guaranty and Indemnification Agreement (the “Continuing Guaranty”) with AmerisourceBergen Corporation attached hereto as Exhibit E.
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15.
|
Term and Termination.
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15.1
|
Term. Unless earlier terminated in accordance with the terms hereof, the term of this Agreement (the “Term”) shall (i) commence as of the Effective Date and will continue in effect for an initial period of three (3) years (the “Initial Term”), and (ii) automatically renew for subsequent periods of two (2) years (each, a “Renewal Term”), unless either party provides written notice to the other at least three (3) months prior to the end of the Initial Term or then-current Renewal Term that it does not wish to renew. The parties will work together in good faith to discuss and agree upon any appropriate fee adjustments at least three (3) months prior to expiration of the Initial Term (or any subsequent Renewal Terms).
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15.2
|
Termination. In addition to any other provision of this Agreement providing for termination hereof, this Agreement may be terminated as follows:
|
(a)
|
Termination by Dyax For Convenience. Dyax may terminate this Agreement for convenience, without cause, upon six (6) months’ prior written notice of termination to US Bio; provided, that, upon any such termination that occurs prior to the second anniversary of the Effective Date, Dyax shall pay US Bio the following amount within [*****] following the effective date of termination: (i) [*****] if prior to the first anniversary of the Effective Date; (ii) [*****] if after the first anniversary of the Effective Date but prior to the second anniversary of the Effective Date; and (iii) [*****] if after the second anniversary of the Effective Date but prior to the third anniversary of the Effective Date.
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(b)
|
Termination For Cause.
|
(i)
|
This Agreement may be terminated by either party on written termination notice to the other party in the event of any material breach of this Agreement by the other party (other than a breach by US Bio of Section 8.2, which is governed by clause (ii) below), which breach is not cured within [*****] days after delivery of written notice by the non-breaching party specifying such breach and requiring cure. Notwithstanding the right to cure provided by the foregoing sentence, US Bio shall have the right to cure only two (2) material breaches of any particular obligation hereunder, and this Agreement may be terminated by Dyax immediately on written notice to US Bio in the event of any additional material breach of such obligation by US Bio.
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(ii)
|
This Agreement may be terminated by Dyax immediately on written notice to US Bio in the event of any material breach by US Bio of Section 8.2.
|
(c)
|
Insolvency. This Agreement may be terminated by either party immediately upon written notice to the other party in the event of any of the following events:
|
(i)
|
the institution by the other party of insolvency, receivership or bankruptcy proceedings or any other material proceedings for the settlement of the other party’s debts, or the institution against the other party of any such proceedings that remain undismissed for [*****];
|
(ii)
|
the other party’s making an assignment for the benefit of its creditors; or
|
(iii)
|
the other party’s dissolution.
|
(d)
|
Other Agreements. In the event that any of (a) the Distribution Services Agreement of even date herewith between Dyax and ASD Specialty Healthcare, Inc. or (b) the Distribution Services Agreement of even date herewith between Dyax and Integrated Commercialization Solutions, Inc. is terminated for any reason, then (i) this Agreement may be terminated by Dyax immediately upon ninety (90) days written notice to US Bio; and (ii) if not terminated by Dyax, US Bio will notify Dyax of any applicable adjustment to the fees based on such termination.
|
(i)
|
This Agreement shall terminate if both: (A) as a result of the enactment of any new applicable federal or state law or regulation, or any change in any existing applicable federal or state law or regulation or any new interpretation of any applicable federal or state law or regulation by any legislative body, court or regulatory agency, the performance by a party of any material obligation under the Agreement would be rendered illegal or any material provision of the Agreement would be rendered invalid or unenforceable, and (B) the parties are unable to negotiate a mutually acceptable amendment to the Agreement pursuant to Section 15.2(e)(iii) below. If any immaterial provision of this Agreement is held to be illegal, invalid or unenforceable for any reason, the Agreement shall be deemed amended to delete such provision, such amendment to apply only with respect to the operation of the Agreement in the particular jurisdiction in which such provision is held to be illegal, invalid or unenforceable, and the remainder of the Agreement shall remain in full force and effect and enforceable in accordance with its terms.
|
(ii)
|
The parties agree that the party affected by the new law or regulation or the change in law or regulation or the interpretation of a law or regulation shall use reasonable efforts to give the other party at least [*****] prior written notice of the effective date of such new law, change, or interpretation.
|
|
(iii)
|
The parties agree that, notwithstanding the foregoing provisions of this Section, either party may, within ten (10) business days of giving or receiving notice of the new law, change or interpretation, notify the other party of its wish to renegotiate the applicable terms of the Agreement (“Renegotiation Notice”), in which event the parties shall negotiate in good faith, for a period of sixty (60) days from delivery of the Renegotiation Notice, an amendment to the Agreement that addresses the portion of the Agreement rendered illegal, invalid or unenforceable by the new law, change or interpretation while preserving to the greatest extent possible the original intent of the Agreement. If the parties successfully conclude such negotiations prior to the effective date of the new law, change or interpretation, the Agreement shall not terminate and shall be amended to reflect the negotiated terms. If the parties are unable to successfully conclude such negotiations prior to the effective date of the new law, change or interpretation and such effective date is within the sixty (60) day negotiation period, the Agreement shall be deemed amended to delete such portion rendered illegal, invalid, or unenforceable, such amendment to apply only with respect to the operation of the Agreement in the particular jurisdiction in which such portion is held to be illegal, invalid or unenforceable, and the remainder shall remain in full force and effect and enforceable in accordance with its terms. In the event the parties are unable to successfully conclude such negotiations within the sixty (60) day negotiation period, the Agreement shall terminate at the end of the sixty (60) day negotiation period.
|
(a)
|
all Confidential Information received hereunder shall be returned to the disclosing party, or destroyed, at the disclosing party’s election (provided that the receiving party may retain one copy to the extent necessary to comply with any contractual or other legal obligations applicable thereto);
|
(b)
|
all rights granted to US Bio with respect to the Product shall terminate and US Bio shall cease in a timely and orderly manner all activities with respect to the selling and distribution of Product; and
|
(c)
|
unless terminated by US Bio pursuant to Section 15.2(b), for a period of [*****] following such expiration or early termination, US Bio and its Affiliates shall provide commercially reasonable assistance in connection with Dyax’s transition of Product distribution and Hub Services to Dyax, its Affiliates or any third party selected by Dyax. Dyax shall reimburse US Bio for its reasonable, documented out-of-pocket costs and expenses incurred with in connection with providing such transition services; provided that, in the event of a termination due to US Bio’s breach, neither the existence of this provision nor the fact of Dyax’s agreement to pay for such transition services shall in any way effect or limit Dyax’s rights or remedies with respect to such breach.
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15.4
|
Termination of Exclusivity. In the event that Dyax has the right to terminate this Agreement for any reason (except pursuant to Section 15.2(a) (Termination for Convenience), Dyax, on immediate written notice to US Bio, may terminate Section 2.3(a)(i), which shall have no further force or effect from and after the delivery of such notice by Dyax. In the event that Dyax terminates this Agreement for convenience pursuant to Section 15.2(a), then US Bio’s obligations under Sections 2.3(a)(ii) and 2.3(a)(iii) shall expire one (1) year after the effective date of termination and thereafter have no further force or effect.
|
16.
|
Dispute Resolution.
|
16.1
|
Resolution by Executives. Any dispute, controversy or claim initiated by either party arising out of, or resulting from the breach or alleged breach by either party of its obligations under this Agreement (other than bona fide third party actions or proceedings filed or instituted in an action or proceeding by a third party against a party to this Agreement), whether before or after termination of this Agreement, shall be in the first instance referred to the respective chief executive officers of the parties unless such dispute or claim must be filed to preserve a legal interest or injunctive relief is required.
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16.2
|
Arbitration. If chief executive officers (or their representatives, it being agreed that the chief executive officer of either party may designate a representative, provided such representative is empowered with decision making in the dispute) of the parties fail to resolve any dispute as provided in Section 16.1 within [*****], then such dispute shall be finally resolved by binding arbitration as follows:
|
(a)
|
Any dispute that might arise between the parties relating to or arising from this Agreement shall be settled by binding arbitration in accordance with the then-prevailing Commercial Arbitration Rules of the American Arbitration Association (“AAA”), except where those rules conflict with this provision, in which case this provision controls. Arbitration shall be conducted before a single arbitrator selected from the AAA’s National Roster of Arbitrators, each of whom shall be a lawyer with at least 15 years experience with a law firm or corporate law department of over 25 lawyers or who was a judge of a court of general jurisdiction. Each party shall have the right to meet and interview the potential arbitrator for no more than one hour each prior to the selection of an arbitrator. The arbitration shall be held, and Dyax and US Bio irrevocably consent to arbitrate, in a mutually agreeable location. The arbitration shall be conducted in English. In rendering the award the arbitrator must apply the substantive law of the State of Delaware (except where that law conflicts with this clause); however, the interpretation and enforcement of this arbitration provision shall be governed by the Federal Arbitration Act. The arbitrator shall render a written opinion setting forth findings of fact and conclusions of law with the reasons therefor stated. Under no circumstances shall the arbitrator award damages in excess of or inconsistent with any limitations of liability contained in this Agreement. Any court with jurisdiction shall enforce this clause and enter judgment on any award. US Bio and Dyax will agree upon, within [*****] after the arbitrator is selected or, if they fail to agree, the AAA will design, procedures that they will follow to assure that the arbitration will be concluded and the award rendered within no more than eight months from selection of the arbitrator.
|
(b)
|
The arbitration proceedings shall be confidential, and neither party shall publicize the nature of any dispute or the outcome of any arbitration proceedings except to the extent required by law, provided in such case the party required to make any disclosure informs the other party of such requirement to allow the other party to seek a protective order. The arbitrator shall issue appropriate protective orders to safeguard each party’s Confidential Information.
|
(c)
|
Each party has the right before or during the arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, an injunction, replevin, etc., to avoid irreparable harm, maintain the status quo or preserve the subject matter of the arbitration.
|
17.
|
Miscellaneous.
|
17.1
|
Relationship of Parties. US Bio’s relationship with Dyax hereunder shall be that of independent contractor, and neither party shall be considered the agent of, partner of, employee or other member of the workforce of, or participant in a joint venture with, the other party. Neither party shall have authority to bind the other party unless otherwise agreed to in writing by such parties.
|
17.2
|
Notices. All notices, requests, demands and other communications required or permitted to be given pursuant to this Agreement shall be in writing and shall be deemed to have been duly given upon the date of receipt if delivered by hand, recognized international overnight courier, confirmed facsimile transmission, or registered or certified mail, return receipt requested, postage prepaid to the following addresses or facsimile numbers:
|
If to Dyax: | Dyax Corp. |
300 Technology Square | |
Cambridge, MA 02139 | |
[*****] | |
If to US Bio: | US Bioservices Corporation |
3101 Gaylord Parkway | |
Frisco, TX 75034 | |
[*****] | |
with a copy to: | |
AmerisourceBergen Specialty Group | |
3101 Gaylord Parkway | |
Frisco, TX 75034 | |
[*****]
|
17.3
|
Assignment. Neither party may assign its rights or delegate its obligations under this Agreement without the prior written consent of the other party, except that either party may assign this Agreement to any of its Affiliates or to a successor in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement, with prompt written notice to the other party of any such assignment; provided that: (i) if such assignee is an Affiliate, the assignor shall responsible for and liable with respect to all assigned obligations and (ii) if such assignee is not an Affiliate, (A) the assignee assumes the assignor’s obligations under the Continuing Guaranty and Indemnification Agreement, and (B) the assignee has net assets as of the end of its most recently completed fiscal year equal to or in excess of the net assets of the assignor as of the end of its most recently completed fiscal year, in each case as set forth in the audited balance sheet of the assignor and assignee, and (iii) in the case of an assignment by Dyax, the assignee is not a Competitor to US Bio. For the purposes of this Section 17.3, a “Competitor” means any organization, entity or person that competes with US Bio including but not limited to the following companies and their affiliated entities: [*****] Notwithstanding the foregoing, US Bio acknowledges and agrees that Dyax may perform its obligations and exercise its rights hereunder through a third party logistics provider.
|
17.4
|
Force Majeure. Each party’s obligation under this Agreement will be excused to the extent any delay or nonperformance is caused by strikes or other labor disturbance, acts of God, war, or other conditions beyond the reasonable control of that party, but only during the duration of such condition.
|
17.5
|
Amendment and Waiver. This Agreement may be amended, supplemented, or otherwise modified only by means of a written instrument signed by both parties. Any waiver of any rights or failure to act in a specific instance shall relate only to such instance and shall not be construed as an agreement to waive any rights or fail to act in any other instance, whether or not similar. To be valid, any waiver must be in writing.
|
17.6
|
Severability. In the event any provision of this Agreement should be held invalid, illegal or unenforceable, the remaining provisions shall not be affected or impaired and the parties shall use all reasonable efforts to replace the applicable provision with a valid, legal and enforceable provision which insofar as practical implements the original intent of such invalid, illegal or unenforceable provision, provided, however, that if the parties fail to reach such agreement within sixty (60) days, a party whose rights or obligations are materially adversely affected as a result of a provision being held invalid, illegal or unenforceable may terminate this Agreement.
|
17.7
|
Headings. All headings used in this Agreement are inserted for convenience only and are not intended to affect the meaning or interpretation of this Agreement or any Article or Section hereof.
|
17.8
|
Successors and Assigns. This Agreement shall be binding on and shall benefit any and all successors, trustees, permitted assigns and other successors in interest of the parties.
|
17.9
|
Applicable Law; Disclaimer of Puerto Rico Law 75.
|
(a)
|
This Agreement shall be construed and enforced in accordance with the laws of the State of Delaware (excluding the choice of law provisions thereof).
|
(b)
|
The parties expressly disclaim, to the fullest extent allowed by Applicable Laws, any application of the Puerto Rico Dealers Act, Law No. 75 of June 1964 (the “Dealers Act”) as amended, and the parties acknowledge that the Dealers Act shall not apply in the interpretation or enforcement of any of the rights and obligations of the parties hereto.
|
17.10
|
Contract Interpretation. The parties have jointly negotiated this Agreement and, thus, neither this Agreement nor any provision will be interpreted for or against any party on the basis that it or its attorney drafted the Agreement or the provision at issue. When this Agreement requires approval of one or more parties, such approval may not be unreasonably withheld or delayed. Words, regardless of the number and gender specifically used, will be construed to include any other number, singular or plural, and any gender, masculine, feminine, or neuter, as the context requires. “And” includes “or.” “Or” is disjunctive but not necessarily exclusive. “Including” means “including but not limited to.” Unless other specifically stated, the term “days” means calendar days.
|
17.11
|
Entire Agreement; No Reliance. Each of the parties agrees and acknowledges that this Agreement, including the Continuing Guaranty and the attachments referred to herein, (i) constitutes the entire agreement and supersedes all prior and contemporaneous agreements, understandings, negotiations and discussions, whether oral or written, between the parties with respect to the subject matter of this Agreement, and (ii) is not intended to confer any rights or remedies, or impose any obligations, on any person other than the parties hereto. Each of the parties expressly agrees and acknowledges that, other than those statements expressly set forth in this Agreement, it is not relying on any statement, whether oral or written, of any person or entity with respect to its entry into this Agreement or to the consummation of the transactions contemplated by this Agreement.
|
17.12
|
Counterparts. This Agreement may be executed in multiple counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. Facsimile execution and delivery of this Agreement are legal, valid and binding execution and delivery for all purposes.
|
US Bioservices Corporation
|
Dyax Corp.
|
|||
By:
|
/s/ Mark O. Johnson
|
By:
|
/s/ Ivana Magovcevic-Liebisch
|
|
Name:
|
Mark O. Johnson
|
Name:
|
Ivana Magovcevic-Liebisch
|
|
Title:
|
President
|
Title:
|
Executive Vice President Corporate Development and General Counsel
|
AmerisourceBergen Specialty Group, Inc.
|
|||
By:
|
/s/ Mike Mullen
|
||
Name:
|
Mike Mullen
|
||
Title:
|
President
|
DYAX CORP.
|
/s/Ivana Magovcevic-Liebisch
|
11/19/09
|
||
Guarantor's Company Name
|
Signature of Authorized Officer
|
Date
|
||
Ivana Magovcevic-Liebisch, EVP Corporate Development
|
||||
Name and Title
|
||||
300 Technology Square, Cambridge, MA 02139
|
||||
Address of Company
|
||||
Revised
|
(617) 225-2500
|
|||
6/2/05
|
Phone
|
1.1
|
"Affiliate" shall mean any individual, corporation, partnership, association, or business that directly or indirectly through intermediaries, controls, is controlled by or is under common control with, a party. An ownership, voting or similar interest (including any right or option to obtain such an interest) representing more than 50% of the total interests then outstanding of the pertinent entity shall constitute "control" for the purposes of this definition.
|
1.2
|
"Applicable Laws" shall mean all applicable laws, rules, regulations in the Territory, including guidelines and guidances promulgated by governmental entities.
|
1.3
|
"Consenting Facility" shall mean each health care facility designated by Dyax that [*****].
|
1.4
|
"FDA" shall mean the United States Food and Drug Administration or any successor agency thereto.
|
1.5
|
"Field" shall mean all uses in the therapeutic treatment of HAE.
|
1.6
|
"Patient" shall mean any person diagnosed with HAE.
|
1.7
|
"Product" shall mean Dyax's proprietary plasma kallikrein inhibitor, known as internally as DX-88 and generically as ecallantide, as more formally described on Exhibit A.
|
1.8
|
"REMS Program" shall mean the Risk Evaluation and Mitigation Program required to be implemented under Section 505-1 of the Federal Food, Drug and Cosmetic Act in connection with the regulatory approval of the Product by the FDA.
|
1.9
|
"SOPs" shall have the meaning set forth in Section 8.3.
|
1.10
|
"Term" shall have the meaning set forth in Section 13.1.
|
1.11
|
"Territory" shall mean the 50 states of the United States of America, the District of Columbia and Puerto Rico.
|
1.12
|
"Wholesale Customers" shall mean hospital, institutional and other pharmacies that purchase Product for their own account for later resale to Patients. For the purpose of this Agreement, "Wholesale Customer" shall also include physicians who purchase Product on a "buy and bill" basis. For the avoidance of doubt, (a) all Wholesale Customers must be enrolled in the REMS Program at the time of sale or distribution of Product thereto by ASD and (b) Wholesale Customer shall not include specialty pharmacies, distributors, or other wholesalers.
|
2.
|
Engagement of ASD.
|
2.1
|
Engagement. Upon the terms and conditions set forth herein, Dyax hereby engages ASD, on an exclusive basis during the Term (subject to Section 13.4), to offer for sale, sell and distribute Product to Wholesale Customers in the Field in the Territory. ASD hereby accepts such engagement and shall offer for sale, sell and distribute Product to Wholesale Customers in the Territory in a professional and responsible manner and in accordance with the terms of this Agreement and all Applicable Laws.
|
2.2
|
Authorized Distributor. In connection with ASD's engagement under Section 2.1 above, and solely for the limited purpose of compliance with the pedigree requirements of the Prescription Drug Marketing Act and any similar state laws, Dyax hereby designates ASD as an Authorized Distributor of Record ("ADR") of the Product during the Term.
|
2.3
|
Exclusivity; Agreement Not to Disadvantage Products. The parties acknowledge and agree that as a result of the exclusive nature of the ASD engagement, subject to Section 13.4, during the Term:
|
(a)
|
Dyax shall not engage any party other than ASD or its Affiliates to distribute Product to Wholesale Customers for the Field in the Territory; and
|
(b)
|
ASD shall not promote any Competing Product in a way that Disadvantages the Product. For the purpose of the foregoing sentence, "Disadvantage" shall mean any activities that (X) are intended to encourage, or could reasonably be foreseen to encourage, the utilization of a Competing Product, such as advertising the Product in a manner that suggests that a Competitive Product is superior to the Product in terms of acquisition price, reimbursement rates, or efficacy, or (Y) otherwise operate to the disadvantage of the Product. For purposes of clarification, announcing a Competing Product on ASD’s web site, listing product changes for a Competing Product (such as indication additions or packaging changes) on ASD’s web site, and providing answers for ASD customers who contact ASD regarding a Competing Product (including responding to questions including (i) what products ASD stocks for a particular disease state, (ii) what are the prices of such products, (iii) what are the indications for such products, and (iv) what are the differences among storage requirements, physical state and administration of the products) are normal promotional activities of a distributor that shall not be considered to Disadvantage the Product.
|
2.4
|
Reserved Rights. Except as expressly provided in this Agreement, no right, title or interest in or to Product or any patent, trade secret, trademark or any other intellectual property right of Dyax or its Affiliates is granted, whether express or implied, by Dyax to ASD. In furtherance of the foregoing and not in limitation thereof, nothing herein shall in any way limit Dyax's ability to (i) offer for sale, sell or distribute Product to Wholesale Customers outside of the Territory, (ii) offer for sale, sell or distribute Product to Wholesale Customers in the Territory for uses outside of the Field or (iii) offer for sale, sell or distribute Product to any person or entity other than a Wholesale Customer, including specialty pharmacies, either directly or through a third party, anywhere in the world. Except as expressly provided in this Agreement, no right, title or interest in or to any patent, trade secret, trademark or any other intellectual property right of ASD or its Affiliates is granted, whether express or implied, by ASD to Dyax. By way of clarification, all proprietary systems, databases and web-based applications, and any standard operating procedures, work rules, programming, software, routines, analytic tools, embedded logic or table structures associated therewith, that have been developed, maintained, utilized and improved by ASD (or its Affiliates) in connection with this Agreement are and will remain the property of ASD (or its Affiliates).
|
2.5
|
Service Level Commitments. The parties to this Agreement desire to define a mutually beneficial relationship between Dyax and ASD in order to achieve Dyax's goals of high patient level product availability, high levels of consumer and pharmacy confidence in the integrity and quality of the Product, and achievement of a collaborative, transparent, and cost-effective distribution system. In order to achieve the stated goals, ASD agrees to offer for sale, sell and distribute the Product hereunder in accordance with the key performance indicators / service level commitments attached hereto as Exhibit B and incorporated herein by this reference.
|
3.
|
Purchase and Sale of Product.
|
3.1
|
Purchase of Product. ASD shall (i) purchase Product only from Dyax and no other supplier, (ii) distribute Product that it has purchased from Dyax, and (iii) offer for sale, sell and distribute Product only to Wholesale Customers for the Field in the Territory. ASD shall fill orders for Product only with Product and shall not substitute other products.
|
(a)
|
The price payable by ASD to Dyax for all Product purchased by ASD hereunder (the "Purchase Price") shall be [*****].
|
(b)
|
Dyax promptly shall invoice ASD for the Purchase Price for all Product purchased hereunder. All Dyax invoices for Product shall be due and payable by ASD within [*****] after receipt by ASD provided, however, [*****]. On all undisputed balances exceeding [*****] from invoice receipt, ASD shall pay interest equal to the lesser of (i) [*****] per month and (ii) the maximum allowed by law.
|
|
(a)
|
With the exception of sales to certain government Wholesale Customers, ASD shall have sole discretion to establish the prices and terms on which ASD sells Product to Wholesale Customers, provided however, that ASD shall not charge Wholesale Customers more than [*****], excluding reasonable upcharges associated with the consignment of Product with such Wholesale Customer and charges for payment by credit card, shipping, sales tax and other transaction based taxes.
|
|
(b)
|
Sales to Government Wholesale Customers. ASD shall make Product available for purchase by 340B covered entities and government entities entitled to purchase off the Federal Supply Schedule ("FSS") at prices below WAC. Dyax shall communicate these discounted prices to ASD quarterly, and shall accept chargeback requests from ASD in accordance with the procedures set forth in Exhibit C. ASD shall use commercially reasonable efforts to ensure that Wholesale Customers claiming the right to purchase at 340B or FSS prices are eligible to do so prior to making the discounted sale. If periods of shortage occur, ASD shall not disproportionately disadvantage either 340B covered entities nor government organizations entitled to purchase off the FSS in order management.
|
|
3.4
|
Chargeback and Deduction Policies. ASD shall abide by Dyax's policies regarding chargebacks ("Chargeback and Deduction Policies") attached hereto as Exhibit C and incorporated by reference herein. Such policies may be altered from time to time by Dyax upon written notice to ASD, provided that if any such change is not acceptable, ASD may terminate this Agreement on [*****] written notice to Dyax.
|
|
3.5
|
Compliance with Safe Harbor. To the extent the safe harbors under 42 C.F.R. § 1001.952 are applicable to payments made under this Agreement, the parties agree to comply with the safe harbors with regard to such payments.
|
4.
|
Delivery of Product to ASD.
|
4.1
|
Product Orders. ASD shall submit all Product orders electronically in the industry standard format in accordance with such procedures as may be mutually agreed upon by the parties. Unless otherwise agreed between the parties, all Product orders shall be submitted in quantities of 20 units (or multiples of 20 units).
|
4.2
|
Delivery Times. Dyax shall make commercially reasonable efforts to ship all ASD orders completely and to have Product from such orders shipped to ASD within a mutually agreeable schedule of up to five (5) business days of order placement. ASD acknowledges and agrees that Dyax may not be able to fill all orders completely or within a specified time due to shortages or other causes and such inability shall not constitute a breach of this Agreement.
|
4.3
|
Product Dating. Dyax shall ship Product to ASD with at least [*****] shelf life remaining, unless otherwise agreed in writing by ASD. [*****]
|
4.4
|
Product Delivery; Risk of Loss. Dyax shall deliver all Product Free On Board to ASD's facility in the Territory designated in the applicable order. For purposes of this Section, the term "Free On Board" means that Dyax shall bear (i) all costs associated with shipping Product to the ASD designated facility, and (ii) all risk of loss for Product until its delivery to the designated ASD facility. Title to, and risk of loss of, all Product shall pass to ASD on delivery.
|
4.5
|
Inspection of Product. ASD shall examine the Product upon delivery at ASD's designated facility and shall notify Dyax in writing within one (1) business day of any problems relating to the quantity of Product delivered or any defect in any of the Product that is reasonably discoverable upon visual inspection of the Product without unpacking of pallets.
|
4.6
|
No Alteration. ASD shall not alter the Product in any way, including the packaging thereof, without Dyax's written consent (except to remove the Product from the shipping containers) and shall not alter the Product labeling.
|
4.7
|
Storage Conditions. ASD will maintain Product stored at, and shipped from, its facilities under (i) the Product storage, shipment and handling requirements set forth in the FDA approved labeling and (ii) any additional requirements mutually agreed upon between ASD and Dyax. ASD shall notify Dyax within one (1) business day of any known deviation from such requirements so that Dyax can determine whether any further action must be taken with respect to such Product. Failure of ASD to notify Dyax promptly of such known deviation shall constitute a breach of this Agreement by ASD.
|
5.
|
Product Inventories.
|
5.1
|
Inventory Levels. During the Term, unless otherwise agreed to by Dyax in writing and subject to Section 5.2, ASD shall maintain at all times a Warehouse Inventory of Product in an amount equal to not less than [*****] nor more than [*****] of ASD's Expected Sales (as defined herein) to Wholesale Customers. [*****]
|
5.2
|
Supply Shortages. ASD shall have no obligation to maintain the minimum inventory levels described in Section 5.1 if Product is unavailable from Dyax.
|
5.3
|
Consignment Arrangements. Subject to the additional terms set forth in Exhibit D, ASD shall install Product in each Consenting Facility designated by Dyax that has an existing Cubixx® refrigerated cabinet. Furthermore, upon payment by Dyax of the applicable fee specified in Exhibit D, ASD shall install in each Consenting Facility designated by Dyax a Cubixx refrigerated cabinet (a "Dyax Consignment Unit"). As between Dyax and ASD, ASD shall be solely responsible for the maintenance of all Cubixx refrigerated cabinets and Dyax Consignment Units. ASD shall use commercially reasonable efforts to ensure that no product other than Product is kept or stored in any Dyax Consignment Unit. Furthermore, ASD shall use commercially reasonable efforts to ensure that each Consignment Unit and Cubixx refrigerated cabinet is stocked at all times with reasonably sufficient amounts of Product to satisfy demand for product in the applicable Consenting Facility. ASD shall reasonably assist Dyax to obtain the consent of each health care facility designated by Dyax to the installation of a Dyax Consignment Unit or Cubixx refrigerated cabinet.
|
6.
|
Product Returns.
|
7.
|
Suspension, Recalls and Government Notices.
|
7.1
|
Suspension. Upon written notification by Dyax to suspend distribution of Product, ASD immediately shall suspend its distribution of Product. If the suspension continues for more than [*****], Dyax will repurchase the Product in saleable condition held in inventory by ASD at the price paid for such Product by ASD. All repurchased Product shall be returned to Dyax at Dyax's expense.
|
7.2
|
Recalls.
|
(a)
|
Recalls Procedures. Dyax shall promptly notify ASD of any recalls or market withdrawals initiated by Dyax or required by the FDA or any other governmental agency. ASD shall notify Dyax immediately of any event or circumstance that ASD reasonably believes may necessitate a recall or market withdrawal. Upon receipt of notice of a recall or market withdrawal from Dyax, ASD shall administer such recall or market withdrawal under the direction of Dyax, including promptly notifying the affected Wholesale Customers of ASD in accordance with Dyax's instructions. Dyax shall provide ASD with a form letter to be used in connection with notice of any recall or market withdrawal, and shall, to the extent practicable, provide ASD the opportunity to review and comment on such letter. Dyax shall be responsible for the mailing, shipping, and reasonable administrative expenses incurred by ASD in connection with the recall or market withdrawal, plus a reasonable service fee as mutually agreed upon in advance by the parties as well as the cost of replacement Product for ASD's Wholesale Customers, except to the extent that such recall or market withdrawal arises or results from (i) the negligence or intentional misconduct of ASD or any of its permitted agents or employees or (ii) the breach by ASD of this Agreement, in which event ASD shall bear and be responsible for such costs as well as the reasonable, documented, out-of-pocket expenses of Dyax incurred in connection with such recall or market withdrawal.
|
(b)
|
Investigations; Cooperation. ASD shall fully cooperate with Dyax in investigating any Product failure that resulted in the need for a recall or market withdrawal and any reasonable, documented, out-of-pocket cost involved with such investigation shall be reimbursed by Dyax, except to the extent that such recall or market withdrawal arises or results from (i) the negligence or intentional misconduct of ASD or any of its permitted agents or employees or (ii) the breach by ASD of this Agreement, in which event ASD shall bear and be responsible for such costs as well as the reasonable, documented, out-of-pocket expenses of Dyax incurred in connection with such investigation.
|
7.3
|
Government Notices. Each party shall provide the other with a copy of any correspondence or notices it receives from the FDA, or other governmental entity specifically relating to the Product or activities conducted under this Agreement, no later than one (1) business day following such receipt. Each party shall also provide the other with concurrent copies of any responses to any such correspondence or notices (e.g., a response to an FDA 483 notice, warning letter, or untitled regulatory letter); provided that Dyax shall review and approve all such responses by ASD to the extent related to the Product and to the extent reasonably feasible. Where reasonably possible, ASD shall give prior notice to Dyax of any scheduled FDA or other governmental inspection of ASD's facilities specifically relating to the Product, and, if reasonably possible, will afford Dyax the opportunity to be present at such inspection.
|
8.
|
Additional ASD Obligations and Services.
|
8.1
|
REMS Program. ASD shall distribute Product and otherwise conduct all activities under this Agreement in accordance with the REMS Program and any additional policies Dyax implements and provides in writing to ASD.
|
8.2
|
Adverse Event Reporting. In the event that an adverse experience, as that term is defined at 21 C.F.R. § 600.80 (as such provision may be amended from time to time), with regard to the Product is reported to ASD, ASD shall ensure that all applicable safety and other relevant information relating to the Product that is obtained during the course of any interaction with patients, healthcare providers, or other individual, is communicated and maintained in accordance with Applicable Laws. ASD shall notify Dyax of any adverse drug experiences with regard to the Product within three (3) business days after its first receipt; provided however, that any information relating to a serious adverse experience (SAE), as that term is defined at 21 C.F.R. § 600.80 (as such provision may be amended from time to time), shall be provided to Dyax within one (1) business day after its first receipt. ASD shall also make all reasonable efforts to assist Dyax with any follow-up investigation necessary to comply with Applicable Laws with respect the reporting of adverse drug experiences relating to the Product; provided, that ASD will not be responsible for reporting of any adverse events to the FDA. Dyax and ASD will ensure that appropriate SOPs (as defined in Section 8.3) regarding adverse experiences are established and/or maintained and regularly reviewed to ensure compliance in accordance with the terms of this Agreement and Applicable Laws. Dyax and ASD will ensure that all staff involved in these activities is appropriately trained and records of such training are maintained.
|
8.3
|
Standard Operating Procedures. ASD shall conduct all activities under this Agreement in accordance with all Standard Operating Procedures ("SOPs") applicable to such activities, as established and approved in writing by the parties from time to time. Any material changes to such SOPs or any new SOPs, to the extent that they specifically relate exclusively to Dyax or the Product (and not the general processes of ASD or products of other ASD clients), shall be subject to the prior written consent of Dyax. Notwithstanding anything to the contrary contained in this Agreement or elsewhere, during the Term of this Agreement, Dyax shall be permitted, upon its reasonable request, to review all SOPs at ASD’s facility. Except for SOPs that are specific and exclusive to Dyax Product ("Dyax SOPs"), the SOPs are confidential and proprietary to ASD and shall not be disclosed by Dyax to any third party. The parties acknowledge and agree that the Dyax SOPs are the property of Dyax and, upon termination or expiration of this Agreement, ASD will deliver such SOPs to Dyax. Upon termination of this Agreement, any of ASD’s internal standard operating procedures (excluding Dyax SOPs) in Dyax’s possession will be returned to ASD or (at ASD’s election) destroyed by Dyax, with Dyax providing ASD with a written certification of destruction.
|
8.4
|
No Subcontracting or Subdistribution. All obligations and services to be performed by ASD under this Agreement shall be solely performed by ASD and ASD shall not outsource or subcontract any of its obligations hereunder without Dyax's prior written consent, except to an affiliate of ASD.
|
8.5
|
Applicable Laws and Regulations. ASD shall conduct all activities under this Agreement in compliance with all Applicable Laws, including federal and state wholesale and pedigree laws, laws relating to the promotion of prescription medicines including the prohibition of off-label promotion, federal and state laws protecting the privacy of patient medical information (including HIPAA if applicable), federal and state anti-kickback laws and regulations, laws relating to the disposal of pharmaceutical products and hazardous wastes, and all applicable professional and industry standards and good business practices. If Dyax reasonably determines that ASD has conducted activities under this Agreement in a manner that could potentially compromise public health or safety, then Dyax may terminate this Agreement immediately, and whether or not Dyax terminates this Agreement, may pursue all other legal remedies available to it.
|
8.6
|
Product Promotion. ASD will not provide any information regarding the safety, effectiveness, or use of Product to Wholesale Customers or other persons or entities except as approved in advance in writing by Dyax. ASD may provide information on its own distribution services to its Wholesale Customers in accordance with ASD standard business practices, including informing its Wholesale Customers of pricing available for the Product and other products distributed by ASD. ASD warrants that any information it provides to its Wholesale Customers regarding Product or its services will be truthful and non-misleading and will comply with all Applicable Laws.
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8.7
|
Discounts. To the extent required by Applicable Laws, including 42 U.S.C. §§ 1320a-7b(b) and in conformance with the standards set forth in 42 C.F.R. § 1001.952(h) for safe harbor protection, ASD shall advise and inform each of its Wholesale Customers to fully report, as required by law or contract, any discounts, rebates, or reductions in prices on Product and provide the discount information supplied by ASD to the Department of Health and Human Services or a state agency upon request, consistent with the requirements of 42 U.S.C. § 1320a-7b(b) and 42 C.F.R. § 1001.952(h).
|
8.8
|
Diversion. ASD shall notify Dyax in writing promptly within one (1) business day of learning of information to suggest that any person or entity is diverting or attempting to divert Product. For the purposes of this Section 8.8, "diverting" means the unauthorized sale, distribution, purchase, receipt, or handling of Product. Dyax may immediately terminate this Agreement upon written notice if ASD has purchased Product from sources other than Dyax.
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9.
|
Reports and Records.
|
9.1
|
EDI Reports. ASD shall prepare and deliver to Dyax the following reports utilizing (i) the reporting and parameters recognized by the American National Standards Institute ("ANSI"), (ii) the Electronic Data Interchange ("EDI") guidelines established by the Healthcare Distribution Management Association ("HDMA"), and (iii) any required specifications from Dyax, which may change from time to time with reasonable notice to ASD:
|
(a)
|
EDI 844. The HDMA Product Transfer Account Adjustment ("EDI 844") shall be submitted to Dyax in accordance with Chargeback and Deduction Policies listed in Exhibit C;
|
(b)
|
EDI 850. The HDMA Product Purchase Order ("EDI 850") shall be submitted to Dyax in accordance with such procedures as may be mutually agreed upon by the parties;
|
(c)
|
EDI 852. Inventory Level and Status Report ("EDI 852") shall be submitted to Dyax on a daily basis. ASD shall provide Dyax the EDI 852 information in a readable format such as MS Excel;
|
(d)
|
EDI 867. The HDMA Product Transfer and Resale Report ("EDI 867") shall be submitted to Dyax on a weekly basis, by no later than 11:59 p.m. on Monday for the previous business week. ASD shall provide Dyax the EDI 867 information in a readable format such as MS Excel; and
|
(e)
|
Other Data Reports. Additional HDMA reports submitted and/or received, as applicable, shall include but are not limited to the following: Invoices ("EDI 810"), Electronic Funds Transfer ("EDI 820"), Electronic Chargeback ("EDI 844"), Price Authorizations ("EDI 845") Chargeback Reconciliations ("EDI 849"), Purchase Order Acknowledgements ("EDI 855"), Advance Shipment Notices ("EDI 856"), Return Merchandise Authorizations ("EDI 180") and the Debit/Adjustment Memo ("EDI 812"). The foregoing Data Reports shall be provided to Dyax on a weekly basis.
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9.2
|
Activity Reports. In addition to any specific reports that ASD may be required to deliver to Dyax under this Agreement, ASD shall provide to Dyax all information and reports related to its activities with respect to the Product that are reasonably requested by Dyax; provided that ASD shall be fully reimbursed by Dyax for any additional expense incurred in connection with the preparation and delivery of such information and/or reports.
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9.3
|
Ownership and Use of Data. Subject to Applicable Laws, Dyax shall have the following rights with respect to information and data relating to Product, the sale of Product to Wholesale Customers and the use by Product of Patients obtained, maintained, generated or furnished by ASD to Dyax in connection with performing ASD’s obligations hereunder, including such data and information contained in the reports delivered pursuant to Sections 9.1 and 9.2:
|
(a)
|
With respect to all reports provided by ASD to Dyax under this Agreement (including this Section 9), Dyax shall own and have the right to use all such reports and all such information shall be deemed to be Dyax Confidential Information; and
|
(b)
|
ASD shall own all sales and distribution data generated through its performance of this Agreement and grants Dyax a non-exclusive, perpetual right to use such data for its internal purposes.
|
(c)
|
With respect to all information and data not covered by Section 9.3(a) and (b), Dyax shall have a right to use any and all information and data, for any purpose as permitted by law or, to the extent such data contain PHI, as permitted by the applicable patient’s written authorization.
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9.4
|
Records. ASD shall keep complete and accurate books and records pertaining to ASD's activities under this Agreement. Such books and records shall be retained for at least [*****] after the expiration or termination of this Agreement or for such longer period as may be required by Applicable Law.
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9.5
|
Audits. Dyax, at its expense, from time to time may perform, or have an independent third party auditor (subject to execution of a mutually agreeable nondisclosure agreement) perform, audits of the records maintained pursuant to Section 9.4 and may observe, or have an independent third party auditor observe, the performance by ASD of its activities hereunder to verify the status of Product and ensure compliance with the terms of this Agreement. Dyax shall provide ASD with at least ten (10) business days advance notice of such audits or observations, and shall conduct any audit or observation during normal business hours in a manner that does not interfere with ICS’s normal business operations. ASD shall make available relevant records that do not contain information pertaining to ASD’s other suppliers, customers or products and permit such observations. Dyax and ASD shall discuss the results of any such audits or observations and ASD shall implement all corrective measures reasonably requested by Dyax. All audits shall be reasonable in time and scope.
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10.
|
Confidentiality.
|
10.1
|
Confidential Information. All confidential, non-public documents and other information disclosed to a party by or on behalf of the other party pursuant to this Agreement, which includes but is not limited to information concerning prices, fees and proposals, operating and sales data, quantities purchased by any customer, information about processes (including SOPs), systems, strategic plans, business plans, financial information, customer information, information concerning patients or physicians, methods, databases, technology (including software and all source code), and any other information or materials prepared or derived from such information (collectively, "Confidential Information"), shall, subject to Sections 10.2 and 10.3, be held by the receiving party in strict confidence and not disclosed either directly or indirectly to any third party (other than affiliates, advisors and consultants who have a need to know such information and who are subject to obligations of confidentiality at least as onerous as those set forth herein) and shall only be used for purposes of fulfilling the receiving party's obligations, or exercising its rights, under this Agreement. Notwithstanding the foregoing, all data and information owned by Dyax pursuant to Section 9.3 shall be the Confidential Information of Dyax and not ASD, and regardless of the party that discloses such Confidential Information hereunder, Dyax shall be deemed the disclosing party, and ASD shall be deemed the receiving party, with respect to such Confidential Information. The terms and conditions of this Agreement and any amendments or addenda thereto shall be deemed the Confidential Information of each party.
|
10.2
|
Exclusions from Confidentiality. Notwithstanding anything to the contrary in this Agreement, the receiving party shall have no liability to the disclosing party for the use or disclosure of any Confidential Information that the receiving party can establish by written documentation to:
|
(a)
|
have been publicly known prior to disclosure by the disclosing party of such information to the receiving party;
|
(b)
|
have become publicly known without fault on the part of the receiving party, subsequent to disclosure to the receiving party;
|
(c)
|
have been received by the receiving party at any time from a source, other than the disclosing party, lawfully having possession of and the right to disclose such information;
|
(d)
|
have been otherwise known by the receiving party prior to disclosure by the disclosing party to the receiving party of such information; or
|
(e)
|
have been independently developed by the receiving party without use of information disclosed by the Disclosing Party.
|
10.3
|
Required Disclosure. A party receiving Confidential Information may disclose such Confidential Information if required to do so by a court (or other governmental agency or stock exchange of competent jurisdiction), any governmental body or as required under any Applicable Laws; provided that (i) the party required to disclose such Confidential Information provides prompt notice of such pending disclosure to the disclosing party so that the disclosing party can seek a protective order or to prevent such disclosure, and (ii) the party required to disclose such Confidential Information shall exercise reasonable efforts to ensure that the information is accorded confidential treatment by the court or other governmental agency or stock exchange.
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10.4
|
Survival of Confidentiality Obligations. The provisions of this Section 10 shall survive for a period of [*****] following the expiration or termination of this Agreement.
|
10.5
|
Injunctive Relief. Each party acknowledges that the failure by the Receiving Party to comply with any of the provisions of this Section 10 will result in irreparable injury and continuing damage to the disclosing party for which there will be no adequate remedy at law and that, in the event of a failure of the receiving party so to comply, the disclosing party shall be entitled to such preliminary and permanent injunctive relief as may be necessary to ensure compliance with all the provisions of this Section 10 without having to prove actual damages or to post a bond.
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11.
|
Additional Representations, Warranties and Covenants.
|
11.1
|
Authorization. Each party represents and warrants to the other party that it has the legal right and power to enter into this Agreement, to extend the rights and licenses granted to the other in this Agreement, and to fully perform its obligations hereunder, and that the performance of such obligations will not conflict with its charter documents or any agreements, contracts, or other arrangements to which it is a party. Furthermore, no approvals, consents, orders or authorizations of or designation, registration, declaration or filing with any governmental authority (within the Field in the Territory) is required for either party's performance of its obligations under this Agreement, other than any approvals that have been obtained already or will be obtained in the ordinary course of the performance of such obligations.
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11.2
|
No Other Agreements. Each party represents and warrants to the other that this Agreement is not dependent on, and does not operate in conjunction with (either explicitly or implicitly), any other arrangement between Dyax and ASD.
|
11.3
|
Dyax Representations and Warranties. Dyax hereby represents and warrants to ASD that, at the time of delivery of Product by Dyax to ASD hereunder: (a) such Product shall not in any material respect be adulterated, misbranded or otherwise prohibited within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et. seq., as amended and in effect at the time of delivery (the "Act"), or within the meaning of any applicable state or local law; (b) such Product will be merchandise that may be introduced and delivered into interstate commerce under the provisions of Section 301 of the Act or Section 351 of the Public Health Service Act; (c) Dyax (or as applicable its designated third-party logistics provider) has and will maintain, in full force and effect, all licenses and permits required under Applicable Laws for Dyax to sell and distribute such Product under this Agreement; (d) such Product will be the subject of a duly approved Biologics License Application and may be legally transported or sold under Applicable Laws; (e) such Product will have been approved by each applicable governmental authority for commercial sale and shipment of such Product within the Territory; and (f) Dyax either (i) owns or holds the duly approved Biologics License Application, as such term is used in the Public Health Service Act, Title 21, United States Code, as amended for such Product, or (ii) is otherwise considered the "manufacturer" of such Product within the meaning of any applicable federal, state or local law relating to pedigrees.
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11.4
|
Product Pricing. ASD represents and warrants that:
|
(a)
|
it will refrain from doing anything that would impede Dyax from meeting any reporting obligations with respect to Product pricing that Dyax may have under Applicable Laws;
|
(b)
|
ASD will properly report the Product sales price to the customer on the invoices or statements submitted by ASD to Dyax; and
|
(c)
|
no discount provided or other payment made pursuant to this Agreement is intended in any way as a discount related to a drug formulary and has not been negotiated or discussed between the parties in connection with any drug formulary.
|
11.5
|
Federal Programs. ASD represents, warrants and covenants to Dyax that (a) neither ASD nor any of its Affiliates that perform activities under this Agreement has been debarred or is subject to debarment pursuant to Section 306 of the Act or listed on either Excluded List (as defined herein), and (b) neither ASD nor any of its Affiliates that perform activities under this Agreement will knowingly (after reasonable investigation) use in any capacity, in connection with the services to be performed under this Agreement, any person who has been debarred pursuant to Section 306 of the Act, or who is the subject of a conviction described in such section, or listed on either Excluded List. ASD shall inform Dyax in writing immediately if it or any person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 of the Act or listed on either Excluded List, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of ASD's knowledge, is threatened, relating to the debarment or conviction Section 306 of the Act, or listing on either Excluded List, of ASD or any person performing services hereunder. "Excluded Lists" means the Department of Health and Human Service's List of Excluded Individuals/Entities and the General Services Administration's Lists of Parties Excluded from Federal Procurement and Non-Procurement Programs.
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11.6
|
Prescriber Identifiable Laws. Dyax warrants that it will not use or disclose any information provided by ASD in a manner inconsistent with any Applicable Laws, including any laws relating to the identity of any prescriber. ASD warrants that it will not disclose any information to Dyax in contravention of any Applicable Laws, including any laws relating to the identity of any prescriber.
|
11.7
|
ASD/Licensure. ASD represents and warrants that it now has and shall maintain in full force during the Term all applicable federal and state wholesaler and other licenses or approvals required under Applicable Laws and regulations to fulfill its obligations under this Agreement in each state in the Territory, the District of Columbia and Puerto Rico. ASD promptly shall notify Dyax of any denials, revocations or suspension of license or registrations by any state or federal agency or any other regulatory authority in the Territory, or any written notice from a governmental body proposing such a denial, revocation or suspension of a license or registration. ASD shall promptly provide Dyax with notice of any material communications with pharmacy and/or wholesaler licensing boards which relate to potential problems with facilities, operations, contractors or procedures used by ASD in distribution of the Product, including notices of inquiries, investigations or inspections and resulting findings, except that in no event shall ASD be required to disclose information concerning its other suppliers or customers or the products of such other suppliers.
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11.8
|
No Other Warranties. Except as expressly provided herein and in the Continuing Guaranty, neither party hereto makes any representations or warranties to the other party, express or implied, either in fact or by operation of law, by statute or otherwise, and each party specifically disclaims any express or implied representations and warranties of merchantability or fitness for a particular purpose.
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12.
|
Liability, Indemnification and Insurance.
|
12.1
|
Remedies.
|
(a)
|
Generally. Rights and remedies under this Agreement are cumulative and in addition to any other available rights or remedies under any other agreement, at law or in equity.
|
(b)
|
Equitable Relief. If either party violates or threatens to violate any provision of this Agreement, the other party may suffer irreparable harm and its remedies at law may be inadequate. Accordingly, the other party may seek equitable relief.
|
12.2
|
Indemnification.
|
(a)
|
Indemnification by ASD. ASD shall indemnify, defend, and hold harmless Dyax and its Affiliates and its and their respective directors, officers, employees, representatives and agents and their respective successors, heirs and assigns (the "Dyax Indemnitees") against any liability, damage, loss, penalty, fine or expense (including reasonable attorneys fees and expenses of litigation) (collectively, "Losses") incurred by or imposed upon the Dyax Indemnitees or any of them in connection with any claims, suits, demands, investigations, enforcement actions, or judgments, in each case initiated by a third party (including any governmental or regulatory agency) (collectively, "Third Party Claims") which arise out of: (a) the gross negligence or willful misconduct of ASD in connection with this Agreement; or (b) the breach of this Agreement by ASD, in each case except for those Losses for which Dyax has an obligation to indemnify ASD pursuant to Section 12.2(b), as to which Losses each party shall indemnify the other to the extent of its respective liability for such Losses.
|
(b)
|
Indemnification by Dyax. Dyax shall indemnify, defend, and hold harmless ASD and its Affiliates and its and their respective directors, officers, employees, representatives and agents and their respective successors, heirs and assigns (the "ASD Indemnitees") against any Losses incurred by or imposed upon ASD Indemnitees or any of them in connection with any Third Party Claims which arise out of: (a) the negligence or willful misconduct of Dyax in connection with this Agreement; (b) the breach of this Agreement by Dyax, (c) any claims of patent, trademark, copyright or other infringement related to Products, or (d) the storage, handling, use, non-use, demonstration, consumption, ingestion, digestion, manufacture, production and assembly of Products and their transportation to ASD (except to the extent that such activities are conducted on Dyax's behalf by an Affiliate of ASD), in each case except for those Losses for which ASD has an obligation to indemnify Dyax pursuant to Section 12.2(a), as to which Losses each party shall indemnify the other to the extent of its respective liability for such Losses.
|
(c)
|
Indemnification Procedure. A party that intends to claim indemnification under this Section 12.2 (the "Indemnitee") shall: (i) promptly notify the indemnifying party (the "Indemnitor") in writing of any Third Party Claim in respect of which the Indemnitee or any of its Affiliates or any of their respective directors, officers, employees, representatives, agents or their respective successors, heirs or assigns intend to claim such indemnification hereunder; (ii) provide the Indemnitor sole control of the defense and/or settlement thereof with counsel reasonably satisfactory to the Indemnitee; provided, however, that the Indemnitee reserves the right to retain its own counsel to defend itself in, but not control the defense of, such suit, at its own expense, unless (a) the interests of the Indemnitee and the Indemnitor in the suit conflict in such a manner and to such extent as to require, consistent with applicable standards of professional responsibility, the retention of separate counsel for the Indemnitee, in which case, the Indemnitor shall pay for one separate counsel chosen by the Indemnitee or (b) the Indemnitor shall not have employed attorneys reasonably satisfactory to the Indemnitee to defend any action within a reasonable time after notice of commencement of such action and (iii) provide the Indemnitor, at the Indemnitor's request and expense, with reasonable assistance and full information with respect thereto. Neither the Indemnitor nor the Indemnitee shall be responsible to or bound by any settlement made by the other without its prior written consent, which shall not be unreasonably withheld or delayed. Without limiting the foregoing provisions of this Section 12.2(c), the Indemnitor shall keep the Indemnitee reasonably informed of the progress of any claim, suit or action under this Section 12.2 and the Indemnitee shall have the right to participate in any such claim, suit or proceeding with counsel of its choosing at its own expense, but the Indemnitor shall have the sole right to control the defense or settlement thereof in accordance with the terms of this Section 12.2(c).
|
12.3
|
Limitation of Liability.
|
(a)
|
Neither party shall be liable to the other for special, exemplary, consequential, incidental (including lost or anticipated revenues or profits), indirect or punitive damages arising from the performance or nonperformance of such party under this Agreement whether such claim is based on contract, tort (including negligence) or otherwise, even if an authorized representative of such party is advised of the possibility or likelihood of same.
|
(b)
|
Notwithstanding the exclusions and limitations of liability set forth in Section 12.3(a) above, such exclusions and limitations shall not apply to: (i) either party's indemnification obligations pursuant to Section 12.2; or (ii) either party's breach of the party's confidentiality obligations pursuant to Article 10.
|
12.4
|
ASD Insurance Obligations. During the Term, ASD shall maintain the following minimum levels of insurance:
|
(a)
|
Employer's liability insurance with a limit of $[*****] for bodily injury by accident per person, $[*****] for bodily injury by accident, all persons and $[*****] bodily injury by disease policy limit;
|
(b)
|
Commercial general liability insurance, including personal injury blanket contractual liability and broad form property damage, with a $[*****] combined single limit;
|
(c)
|
Umbrella liability insurance in the amount of $[*****] per occurrence and aggregate; and
|
(d)
|
Property insurance covering the business property of ASD and others while at any unnamed location in the amount of $[*****].
|
12.5
|
Dyax Insurance Obligation; Continuing Guaranty. During the Term, Dyax will maintain products liability and commercial general liability insurance having a limit of not less than [*****] per occurrence, Combined Single Limit (Bodily Injury and Property Damage), pursuant to one or more insurance policies with reputable insurance carriers having a Best’s Rating of A VII or otherwise as reasonably approved by ASD. Dyax will designate ASD and its Affiliates as an "additional insured" under such insurance policy and will obtain a broad form vendor’s endorsement for products liability for ASD. Within thirty (30) days after the Effective Date, Dyax will provide to ASD a certificate of insurance indicating that such obligations have been satisfied. As a condition precedent to the effectiveness of this Agreement, Dyax will execute the form of Continuing Guaranty and Indemnification Agreement (the "Continuing Guaranty") with AmerisourceBergen Corporation attached hereto as Exhibit F.
|
13.
|
Term and Termination.
|
13.1
|
Term. Unless earlier terminated in accordance with the terms hereof, the term of this Agreement (the "Term") shall (i) commence as of the Effective Date and will continue in effect for an initial period of three (3) years (the "Initial Term"), and (ii) automatically renew for subsequent periods of two (2) years (each, a "Renewal Term"), unless either party provides written notice to the other at least three (3) months prior to the end of the Initial Term or then-current Renewal Term that it does not wish to renew. The parties will work together in good faith to discuss and agree upon any appropriate fee adjustments at least three months prior to expiration of the Initial Term.
|
13.2
|
Termination. In addition to any other provision of this Agreement providing for termination hereof, this Agreement may be terminated as follows:
|
(a)
|
Termination by Dyax For Convenience. Dyax may terminate this Agreement for convenience, without cause, upon six (6) months’ prior written notice of termination to ASD.
|
(b)
|
Termination For Cause.
|
(i)
|
This Agreement may be terminated by either party on written termination notice to the other party in the event of any material breach of this Agreement by the other party (other than a breach by ASD Section 8.1, which is governed by clause (ii) below), which breach is not cured within [*****] after delivery of written notice by the non-breaching party specifying such breach and requiring cure. Notwithstanding the right to cure provided by the foregoing sentence, ASD shall have the right to cure only two (2) material breaches of any particular obligation hereunder, and this Agreement may be terminated by Dyax immediately on written notice to ASD in the event of any additional material breach of such obligation by ASD.
|
(ii)
|
This Agreement may be terminated by Dyax immediately on written notice to ASD in the event of any material breach by ASD of Section 8.1.
|
(c)
|
Insolvency. This Agreement may be terminated by either party immediately upon written notice to the other party in the event of any of the following events:
|
(i)
|
the institution by the other party of insolvency, receivership or bankruptcy proceedings or any other material proceedings for the settlement of the other party's debts, or the institution against the other party of any such proceedings that remain undismissed for [*****];
|
(ii)
|
the other party's making an assignment for the benefit of its creditors; or
|
(iii)
|
the other party's dissolution.
|
(d)
|
Other Agreements. In the event that any of (a) the Distribution Services Agreement of even date herewith between Dyax and US BIOSERVICES CORPORATION, or (b) the Distribution Services Agreement of even date herewith between Dyax and Integrated Commercialization Solutions, Inc. is terminated for any reason, then (i) this Agreement may be terminated by Dyax immediately upon written notice to ASD; and (ii) if not terminated, ICS will notify Dyax of any applicable adjustment to Fees based upon such termination.
|
(i)
|
This Agreement shall terminate if both: (A) as a result of the enactment of any new applicable federal or state law or regulation, or any change in any existing applicable federal or state law or regulation or any new interpretation of any applicable federal or state law or regulation by any legislative body, court or regulatory agency, the performance by a party of any material obligation under the Agreement would be rendered illegal or any material provision of the Agreement would be rendered invalid or unenforceable, and (B) the parties are unable to negotiate a mutually acceptable amendment to the Agreement pursuant to Section 13.2(e)(iii) below. If any immaterial provision of this Agreement is held to be illegal, invalid or unenforceable for any reason, the Agreement shall be deemed amended to delete such provision, such amendment to apply only with respect to the operation of the Agreement in the particular jurisdiction in which such provision is held to be illegal, invalid or unenforceable, and the remainder of the Agreement shall remain in full force and effect and enforceable in accordance with its terms.
|
(ii)
|
The parties agree that the party affected by the new law or regulation or the change in law or regulation or the interpretation of a law or regulation shall use reasonable efforts to give the other party at least [*****] prior written notice of the effective date of such new law, change, or interpretation.
|
|
(iii)
|
The parties agree that, notwithstanding the foregoing provisions of this Section, either party may, within ten (10) business days of giving or receiving notice of the new law, change or interpretation, notify the other party of its wish to renegotiate the applicable terms of the Agreement ("Renegotiation Notice"), in which event the parties shall negotiate in good faith, for a period of sixty (60) days from delivery of the Renegotiation Notice, an amendment to the Agreement that addresses the portion of the Agreement rendered illegal, invalid or unenforceable by the new law, change or interpretation while preserving to the greatest extent possible the original intent of the Agreement. If the parties successfully conclude such negotiations prior to the effective date of the new law, change or interpretation, the Agreement shall not terminate and shall be amended to reflect the negotiated terms. If the parties are unable to successfully conclude such negotiations prior to the effective date of the new law, change or interpretation and such effective date is within the sixty (60) day negotiation period, the Agreement shall be deemed amended to delete such portion rendered illegal, invalid, or unenforceable, such amendment to apply only with respect to the operation of the Agreement in the particular jurisdiction in which such portion is held to be illegal, invalid or unenforceable, and the remainder shall remain in full force and effect and enforceable in accordance with its terms. In the event the parties are unable to successfully conclude such negotiations within the sixty (60) day negotiation period, the Agreement shall terminate at the end of the sixty (60) day negotiation period.
|
(a)
|
all Confidential Information received hereunder shall be returned to the disclosing party, or destroyed, at the disclosing party's election (provided that the receiving party may retain one copy to the extent necessary to comply with any contractual or other legal obligations applicable thereto);
|
(b)
|
all rights granted to ASD with respect to the Product shall terminate and ASD shall cease in a timely and orderly manner all activities with respect to the selling and distribution of Product; and
|
(c)
|
unless terminated by ASD pursuant to Section 13.2(b) above (Material Breach), for a period of [*****] following such expiration or early termination, ASD and its Affiliates shall provide commercially reasonable assistance in connection with Dyax's transition of Product distribution to Dyax, its Affiliates or any third party selected by Dyax. Dyax shall reimburse ASD for its reasonable, documented out-of-pocket costs and expenses incurred with in connection with providing such transition services; provided that, in the event of a termination due to ASD's breach, neither the existence of this provision nor the fact of Dyax's agreement to pay for such transition services shall in any way effect or limit Dyax's rights or remedies with respect to such breach.
|
|
13.4
|
Termination of Exclusivity. In the event that (i) Dyax has the right to terminate this Agreement for any reason (except pursuant to Section 13.2(a) (Termination for Convenience), Dyax, on immediate written notice to ASD, may terminate Section 2.3(a), which shall have no further force or effect from and after the delivery of such notice by Dyax.
|
14.
|
Dispute Resolution.
|
14.1
|
Resolution by Executives. Any dispute, controversy or claim initiated by either party arising out of, or resulting from the breach or alleged breach by either party of its obligations under this Agreement (other than bona fide third party actions or proceedings filed or instituted in an action or proceeding by a third party against a party to this Agreement), whether before or after termination of this Agreement, shall be in the first instance referred to the respective chief executive officers of the parties unless such dispute or claim must be filed to preserve a legal interest or injunctive relief is required.
|
14.2
|
Arbitration. If chief executive officers (or their representatives, it being agreed that the chief executive officer of either party may designate a representative, provided such representative is empowered with decision making in the dispute) of the parties fail to resolve any dispute as provided in Section 14.1 within [*****], then such dispute shall be finally resolved by binding arbitration as follows:
|
(a)
|
Any dispute that might arise between the parties relating to or arising from this Agreement shall be settled by binding arbitration in accordance with the then-prevailing Commercial Arbitration Rules of the American Arbitration Association ("AAA"), except where those rules conflict with this provision, in which case this provision controls. Arbitration shall be conducted before a single arbitrator selected from the AAA’s National Roster of Arbitrators, each of whom shall be a lawyer with at least 15 years experience with a law firm or corporate law department of over 25 lawyers or who was a judge of a court of general jurisdiction. Each party shall have the right to meet and interview the potential arbitrator for no more than one hour each prior to the selection of an arbitrator. The arbitration shall be held, and Dyax and ASD irrevocably consent to arbitrate, in New York, NY, unless they mutually agree upon an alternative location. The arbitration shall be conducted in English. In rendering the award the arbitrator must apply the substantive law of the State of Delaware (except where that law conflicts with this clause); however, the interpretation and enforcement of this arbitration provision shall be governed by the Federal Arbitration Act. The arbitrator shall render a written opinion setting forth findings of fact and conclusions of law with the reasons therefor stated. Under no circumstances shall the arbitrator award damages in excess of or inconsistent with any limitations of liability contained in this Agreement. Any court with jurisdiction shall enforce this clause and enter judgment on any award. ASD and Dyax will agree upon, within [*****] after the arbitrator is selected or, if they fail to agree, the AAA will design, procedures that they will follow to assure that the arbitration will be concluded and the award rendered within no more than eight months from selection of the arbitrator.
|
(b)
|
The arbitration proceedings shall be confidential, and neither party shall publicize the nature of any dispute or the outcome of any mediation or arbitration proceedings except to the extent required by law, provided in such case the party required to make any disclosure informs the other party of such requirement to allow the other party to seek a protective order. The mediator or arbitrator, as the case may be, shall issue appropriate protective orders to safeguard each party’s confidential information.
|
(c)
|
Each party has the right before or during the mediation or arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, an injunction, replevin, etc., to avoid irreparable harm, maintain the status quo or preserve the subject matter of the arbitration.
|
15.
|
Miscellaneous.
|
15.1
|
Relationship of Parties. ASD's relationship with Dyax hereunder shall be that of independent contractor, and neither party shall be considered the agent of, partner of, employee or other member of the workforce of, or participant in a joint venture with, the other party. Neither party shall have authority to bind the other party unless otherwise agreed to in writing by such parties.
|
15.2
|
Notices. All notices, requests, demands and other communications required or permitted to be given pursuant to this Agreement shall be in writing and shall be deemed to have been duly given upon the date of receipt if delivered by hand, recognized international overnight courier, confirmed facsimile transmission, or registered or certified mail, return receipt requested, postage prepaid to the following addresses or facsimile numbers:
|
If to Dyax: | Dyax Corp. |
300 Technology Square | |
Cambridge, MA 02139 | |
[*****] | |
If to ASD: | AmerisourceBergen Specialty Group |
3101 Gaylord Parkway | |
Frisco, TX 75034 | |
[*****] |
15.3
|
Assignment. Neither party may assign its rights or delegate its obligations under this Agreement without the prior written consent of the other party, except that either party may assign this Agreement to any of its Affiliates or to a successor in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement, with prompt written notice to the other party of any such assignment; provided that: (i) if such assignee is an Affiliate, the assignor shall responsible for and liable with respect to all assigned obligations and (ii) if such assignee is not an Affiliate, (A) the assignee assumes the assignor’s obligations under the Continuing Guaranty and Indemnification Agreement, and (B) the assignee has net assets as of the end of its most recently completed fiscal year equal to or in excess of the net assets of the assignor as of the end of its most recently completed fiscal year, in each case as set forth in the audited balance sheet of the assignor and assignee, and (iii) in the case of an assignment by Dyax, the assignee is not a Competitor to ASD. For the purposes of this Section 15.3, a "Competitor" means any organization, entity or person that competes with ASD including but not limited to the following companies and their affiliated entities: [*****]. Notwithstanding the foregoing, ASD acknowledges and agrees that Dyax may perform its obligations and exercise its rights hereunder through a third party logistics provider.
|
15.4
|
Force Majeure. Each party's obligation under this Agreement will be excused to the extent any delay or nonperformance is caused by strikes or other labor disturbance, acts of God, war, or other conditions beyond the reasonable control of that party, but only during the duration of such condition.
|
15.5
|
Amendment and Waiver. This Agreement may be amended, supplemented, or otherwise modified only by means of a written instrument signed by both parties. Any waiver of any rights or failure to act in a specific instance shall relate only to such instance and shall not be construed as an agreement to waive any rights or fail to act in any other instance, whether or not similar. To be valid, any waiver must be in writing.
|
15.6
|
Severability. In the event any provision of this Agreement should be held invalid, illegal or unenforceable, the remaining provisions shall not be affected or impaired and the parties shall use all reasonable efforts to replace the applicable provision with a valid, legal and enforceable provision which insofar as practical implements the original intent of such invalid, illegal or unenforceable provision, provided, however, that if the parties fail to reach such agreement within sixty (60) days, a party whose rights or obligations are materially adversely affected as a result of a provision being held invalid, illegal or unenforceable may terminate this Agreement.
|
15.7
|
Headings. All headings used in this Agreement are inserted for convenience only and are not intended to affect the meaning or interpretation of this Agreement or any Article or Section hereof.
|
15.8
|
Successors and Assigns. This Agreement shall be binding on and shall benefit any and all successors, trustees, permitted assigns and other successors in interest of the parties.
|
15.9
|
Applicable Law; Disclaimer of Puerto Rico Law 75.
|
(a)
|
This Agreement shall be construed and enforced in accordance with the laws of the State of Delaware (excluding the choice of law provisions thereof).
|
(b)
|
The parties expressly disclaim, to the fullest extent allowed by Applicable Law, any application of the Puerto Rico Dealers Act, Law No. 75 of June 1964 (the "Dealers Act") as amended, and the parties acknowledge that the Dealers Act shall not apply in the interpretation or enforcement of any of the rights and obligations of the parties hereto.
|
15.10
|
Contract Interpretation. The parties have jointly negotiated this Agreement and, thus, neither this Agreement nor any provision will be interpreted for or against any party on the basis that it or its attorney drafted the Agreement or the provision at issue. When this Agreement requires approval of one or more parties, such approval may not be unreasonably withheld or delayed. Words, regardless of the number and gender specifically used, will be construed to include any other number, singular or plural, and any gender, masculine, feminine, or neuter, as the context requires. "And" includes "or." "Or" is disjunctive but not necessarily exclusive. "Including" means "including but not limited to." Unless other specifically stated, the term "days" means calendar days.
|
15.11
|
Entire Agreement; No Reliance. Each of the parties agrees and acknowledges that this Agreement, including the Continuing Guaranty and the attachments referred to herein, (i) constitutes the entire agreement and supersedes all prior and contemporaneous agreements, understandings, negotiations and discussions, whether oral or written, between the parties with respect to the subject matter of this Agreement, and (ii) is not intended to confer any rights or remedies, or impose any obligations, on any person other than the parties hereto. Each of the parties expressly agrees and acknowledges that, other than those statements expressly set forth in this Agreement, it is not relying on any statement, whether oral or written, of any person or entity with respect to its entry into this Agreement or to the consummation of the transactions contemplated by this Agreement.
|
15.12
|
Counterparts. This Agreement may be executed in multiple counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. Facsimile execution and delivery of this Agreement are legal, valid and binding execution and delivery for all purposes.
|
ASD Specialty Healthcare, Inc.
|
Dyax Corp.
|
|||
By:
|
/s/ Chris B. Myers
|
By:
|
/s/ Ivana Magovcevic-Liesbisch
|
|
Name:
|
Chris B. Myers
|
Name:
|
Ivana Magovcevic-Liesbisch
|
|
Title:
|
COO
|
Title:
|
Executive Vice President Corporate
Development and General Counsel
|
AmerisourceBergen Specialty Group, Inc.
|
|||
By:
|
/s/ Mike Mullen
|
||
Name:
|
Mike Mullen
|
||
Title:
|
President
|
DYAX CORP.
|
/s/Ivana Magovcevic-Liebisch
|
11/19/09
|
||
Guarantor's Company Name
|
Signature of Authorized Officer
|
Date
|
||
Ivana Magovcevic-Liebisch, EVP Corporate Development
|
||||
Name and Title
|
||||
300 Technology Square, Cambridge, MA 02139
|
||||
Address of Company
|
||||
Revised
|
(617) 225-2500
|
|||
6/2/05
|
Phone
|
|
1.1
|
"3PL Services" shall have the meaning set forth in Section 3.1.
|
|
1.2
|
"Affiliate" shall mean any individual, corporation, partnership, association, or business that directly or indirectly through intermediaries, controls, is controlled by or is under common control with, a party. An ownership, voting or similar interest (including any right or option to obtain such an interest) representing more than 50% of the total interests then outstanding of the pertinent entity shall constitute "control" for the purposes of this definition.
|
|
1.3
|
"Applicable Laws" shall mean all applicable laws, rules, regulations in the Territory, including guidelines and guidances promulgated by governmental entities.
|
|
1.4
|
"FDA" shall mean the United States Food and Drug Administration or any successor agency thereto.
|
|
1.5
|
"Field" shall mean all uses in the therapeutic treatment of HAE.
|
|
1.6
|
"Product" shall mean Dyax's proprietary plasma kallikrein inhibitor, known as internally as DX-88 and generically as ecallantide, as more formally described on Exhibit A.
|
|
1.7
|
"REMS Program" shall mean the Risk Evaluation and Mitigation Program required to be implemented under Section 505-1 of the Federal Food, Drug and Cosmetic Act in connection with the regulatory approval of the Product by the FDA.
|
|
1.8
|
"SOPs" shall have the meaning set forth in Section 3.2.
|
|
1.9
|
"Statement of Work" shall have the meaning set forth in Section 3.1
|
|
1.10
|
"Term" shall have the meaning set forth in Section 11.1.
|
|
1.11
|
"Territory" shall mean the 50 states of the United States of America, the District of Columbia and Puerto Rico.
|
2.
|
Engagement of ICS.
|
|
2.1
|
Engagement. Upon the terms and conditions set forth herein, Dyax hereby engages ICS, on an exclusive basis during the Term (subject to Section 11.4), to provide 3PL Services in connection with the promotion, offer for sale, sale and distribution of Product in the Field in the Territory. ICS hereby accepts such engagement and shall provide the 3PL Services in a professional and responsible manner and in accordance with the terms of this Agreement and all Applicable Laws.
|
|
2.2
|
Authorized Distributor. In connection with ICS's engagement under Section 2.1 above, and solely for the limited purpose of compliance with the pedigree requirements of the Prescription Drug Marketing Act and any similar state laws, Dyax hereby designates ICS as an Authorized Distributor of Record ("ADR") of the Product during the Term and a third party logistics provider who does not take title to Product or have general responsibility to direct the sale or disposition of Product. The foregoing shall not be construed in a manner that results in ICS being considered a distributor or wholesaler for any other purpose or under any Applicable Laws.
|
|
2.3
|
Exclusivity. The parties acknowledge and agree that as a result of the exclusive nature of the ICS engagement, subject to Section 11.4, during the Term, Dyax shall not engage any party other than ICS or its Affiliates to serve as Dyax's third-party logistic service provider for Product for the Field in the Territory.
|
|
2.4
|
Reserved Rights. Except as expressly provided in this Agreement, no right, title or interest in or to Product or any patent, trade secret, trademark or any other intellectual property right of Dyax or its Affiliates is granted, whether express or implied, by Dyax to ICS. Except as expressly provided in this Agreement, no right, title or interest in or to any patent, trade secret, trademark or any other intellectual property right of ICS or its Affiliates is granted, whether express or implied, by ICS to Dyax. By way of clarification, all proprietary systems, databases and web-based applications, and any standard operating procedures, work rules, programming, software, routines, analytic tools, embedded logic or table structures associated therewith, that have been developed, maintained, utilized and improved by ICS (or its Affiliates) in connection with this Agreement or the Hub Services are and will remain the property of ICS (or its Affiliates).
|
3.
|
3PL Services and Related ICS Obligations.
|
|
3.1
|
3PL Services; Statement of Work. ICS shall provide certain third party logistics services with respect to the Product ("3PL Services"). The specific nature of such 3PL Services, and any additional terms and conditions applicable to such 3PL Services, shall be set forth in writing (each such writing a "Statement of Work"). The initial Statement of Work that has been agreed upon by the parties is attached hereto as Exhibit B. Any changes to the initial Statements of Work or any new Statement of Work must be in writing and approved by both parties, and thereafter shall be considered an addendum to this Agreement. All services performed under any Statement of Work shall be subject to all the terms and conditions set forth herein.
|
|
3.2
|
Standard Operating Procedures. ICS shall conduct all activities under this Agreement in accordance with all Standard Operating Procedures ("SOPs") applicable to such activities, as established and approved in writing by the parties from time to time. Any SOPs specific to Dyax will be discussed and agreed upon by the parties and material changes will be implemented by ICS only at Dyax’s direction. Notwithstanding anything to the contrary contained in this Agreement or elsewhere, during the Term of this Agreement, Dyax shall be permitted, upon its reasonable request, to review all such SOPs at the ICS facility. The SOPs are confidential and proprietary to ICS and shall not be disclosed by Dyax to any third party without the consent of ICS. Upon termination of this Agreement, any SOPs in Dyax’s possession will be returned to ICS or (at ICS’s election) destroyed by Dyax with certification of destruction.
|
|
3.3
|
No Subcontracting or Subdistribution. All obligations and services to be performed by ICS under this Agreement shall be solely performed by ICS and ICS shall not outsource or subcontract any of its obligations hereunder without Dyax's prior written consent, except to an Affiliate of ICS.
|
|
3.4
|
Applicable Laws and Regulations. ICS shall conduct all activities under this Agreement in compliance with all Applicable Laws, including federal and state pharmacy, wholesaler and pedigree laws, federal and state laws protecting the privacy of patient medical information (including HIPAA if applicable), laws relating to the disposal of pharmaceutical products and hazardous wastes, and all applicable professional and industry standards and good business practices. If Dyax reasonably determines that ICS has conducted activities under this Agreement in a manner that could potentially compromise public health or safety, then Dyax may terminate this Agreement immediately, and whether or not Dyax terminates this Agreement, may pursue all other legal remedies available to it.
|
|
3.5
|
Storage Conditions. ICS will maintain Product stored at, and shipped from, its facilities under (i) the Product storage, shipment and handling requirements set forth in the Statement of Work included in Exhibit B, (ii) any applicable SOPs and (iii) any other conditions required by the FDA approved labeling. ICS shall notify Dyax within one (1) business day of any known deviation from such requirements so that Dyax can determine whether any further action must be taken with respect to such Product. Failure of ICS to notify Dyax promptly of such known deviation shall constitute a breach of this Agreement by ICS.
|
|
3.6
|
Title to Product. All right, title and interest in and to all Product at ICS's facility or otherwise in the possession of ICS shall at all times remain the sole property of Dyax. At no time and under no circumstance shall ICS have title to, or any right or interest in or to, any Product at ICS's facility or otherwise in ICS's possession or control. ICS hereby expressly waives and releases any and all liens and claims it may have in respect of any Product arising under any statute, common law or otherwise. ICS from time to time during the Term shall execute such forms, documents and instruments evidencing Dyax's ownership of Product as Dyax reasonably shall request. ICS shall take no action that is inconsistent with the right, title and interest of Dyax in and to the Product and any attempt by ICS to sell, or to grant or create a lien on or security interest in, any Product shall be void ab initio. ICS shall have no authority to store any Product with any other warehouseman or in any place other than ICS's facility. At any time during the Term and for any reason, Dyax may take all or any portion of any Product into its possession by giving ICS notice of such intent, and upon the giving of such notice ICS shall deliver such Product to Dyax in accordance with instructions provided by Dyax, subject to Dyax promptly reimbursing ICS's reasonable actual costs of return and removal.
|
|
3.7
|
Risk of Loss. ICS shall have no risk of loss for all Product at ICS's facility or otherwise in the possession of ICS, except to the extent that ICS’s gross negligence or willful misconduct caused such loss. In such case, any loss due to damage or loss of products will be based upon Dyax's cost of manufacturing or acquiring products, not it's selling cost.
|
|
3.8
|
Diversion. ICS shall notify Dyax in writing within one (1) business day of learning of information to suggest that any person or entity is diverting or attempting to divert Product. For the purposes of this Section 3.8, "diverting" means the unauthorized sale, distribution, purchase, receipt, or handling of Product.
|
|
3.9
|
Product Promotion. ICS shall not provide any information regarding the safety, effectiveness, or use of Product to any persons or entities except as approved in advance in writing by Dyax.
|
4.
|
Compensation for 3PL Services.
|
5.
|
Suspension, Recalls and Government Notices.
|
|
5.1
|
Suspension. Upon written notification by Dyax to suspend distribution of Product, ICS immediately shall suspend its distribution of Product.
|
|
5.2
|
Recalls.
|
|
(a)
|
Recall Procedures. Dyax shall promptly notify ICS of any recalls or market withdrawals initiated by Dyax or required by the FDA or any other governmental agency. ICS shall notify Dyax immediately of any event or circumstance that ICS reasonably believes may necessitate a recall or market withdrawal. Any recall or market withdrawal initiated by Dyax or required by the Untied States Food and Drug Administration shall be conducted in accordance with the Recall Statement of Work, included in the Statements of Work attached as Exhibit B hereto. Any changes to the Recall Statement of Work shall be subject to the terms and conditions set forth in Section 3.1. Dyax shall be responsible for the mailing, shipping, and reasonable administrative expenses incurred by ICS in connection with the recall or market withdrawal, plus a reasonable service fee as mutually agreed upon in advance by the parties. Notwithstanding the foreging, to the extent that such recall or market withdrawal arises or results from (i) the negligence or intentional misconduct of ICS or any of its permitted agents or employees or (ii) the breach by ICS of this Agreement, ICS shall bear and be responsible for such costs as well as the reasonable, documented, out-of-pocket expenses of Dyax incurred in connection with such recall or market withdrawal.
|
|
(b)
|
Investigations; Cooperation. ICS shall fully cooperate with Dyax in investigating any Product failure that resulted in the need for a recall or market withdrawal and any reasonable, documented, out-of-pocket cost involved with such investigation shall be reimbursed by Dyax, except to the extent that such recall or market withdrawal arises or results from (i) the negligence or intentional misconduct of ICS or any of its permitted agents or employees or (ii) the breach by ICS of this Agreement, in which event ICS shall bear and be responsible for such costs as well as the reasonable, documented, out-of-pocket expenses of Dyax incurred in connection with such investigation.
|
|
5.3
|
Government Notices. Each party shall provide the other with a copy of any correspondence or notices it receives from the FDA, or other governmental entity specifically relating to the Product or activities conducted under this Agreement, no later than one (1) business day following such receipt. Each party shall also provide the other with concurrent copies of any responses to any such correspondence or notices (e.g., a response to an FDA 483 notice, warning letter, or untitled regulatory letter); provided that Dyax shall review and approve all such responses by ICS to the extent related to the Product and to the extent reasonably feasible. Where reasonably possible, ICS shall give prior notice to Dyax of any scheduled FDA or other governmental inspection of ICS's facilities specifically relating to the Product, and, if reasonably possible, will afford Dyax the opportunity to be present at such inspection.
|
|
6.
|
Reports and Records.
|
|
6.1
|
Activity Reports. In addition to any specific reports that ICS may be required to deliver to Dyax under this Agreement or any Statement of Work, ICS shall provide to Dyax all information and reports related to its activities with respect to the Product that are reasonably requested by Dyax and can be prepared by ICS without undue burden; provided that ICS shall be compensated and fully reimbursed by Dyax for any additional time and expense incurred in connection with the preparation and delivery of such information and/or reports.
|
|
6.2
|
Ownership of Data. Dyax exclusively shall own all information and data relating to Product, the distribution of Product and the use of Product obtained, maintained, generated or furnished by ICS in connection with performing its obligations hereunder and all data and information contained in the reports delivered pursuant to Section 6.1, except any data, materials or information not specific to the Product or which relate to the general processes, services and reports developed by ICS or which contains ICS’s Confidential Information (the “ICS Information”), and ICS hereby assigns to Dyax all of its right, title and interest in and to such information and data (excluding ICS Information) without additional consideration.
|
|
6.3
|
Records. ICS shall keep complete and accurate books and records pertaining to ICS's activities under this Agreement. Such books and records shall be retained for at least [*****] after the expiration or termination of this Agreement or for such longer period as may be required by Applicable Law.
|
|
6.4
|
Audits. Dyax, at its expense, from time to time may perform, or have an independent third party auditor (subject to execution of a mutually agreeable nondisclosure agreement) perform, audits of the records maintained pursuant to Section 6.3 and may observe, or have an independent third party auditor observe, the performance by ICS of its activities hereunder to verify the status of Product and ensure compliance with the terms of this Agreement. Dyax shall provide ICS with at least ten (10) business days advance notice of such audits or observations, and shall conduct any audit or observation during normal business hours in a manner that does not interfere with ICS’s normal business operations. ICS shall make available relevant records that do not contain information pertaining to ICS’s other clients or products and permit such observations. Dyax and ICS shall discuss the results of any such audits or observations and ICS shall implement all corrective measures reasonably requested by Dyax. All audits shall be reasonable in time and scope.
|
7.
|
Confidentiality.
|
|
7.1
|
Confidential Information. All confidential, non-public documents and other information disclosed to a party by or on behalf of the other party pursuant to this Agreement which includes but is not limited to information concerns prices and quantities purchased by any customer, Product information, operating and sales data, information about systems, strategic plans, business plans, financial information, processes (including SOPs), customer information, information concerning patients or physicians, methods, databases, technology (including software and all source code) and any other information or material prepared or derived from such information (collectively, "Confidential Information"), shall, subject to Sections 7.2 and 7.3, be held by the receiving party in strict confidence and not disclosed either directly or indirectly to any third party (other than Affiliates, advisors and consultants who have a need to know such information and who are subject to obligations of confidentiality at least as onerous as those set forth herein) and shall only be used for purposes of fulfilling the receiving party's obligations, or exercising its rights, under this Agreement. Notwithstanding the foregoing, all data and information owned by Dyax pursuant to Section 6.2 shall be the Confidential Information of Dyax and not ICS, and regardless of the party that discloses such Confidential Information hereunder, Dyax shall be deemed the disclosing party, and ICS shall be deemed the receiving party, with respect to such Confidential Information. The terms and conditions of this Agreement and any amendments or addenda thereto shall be deemed the Confidential Information of each party.
|
|
7.2
|
Exclusions from Confidentiality. Notwithstanding anything to the contrary in this Agreement, the receiving party shall have no liability to the disclosing party for the use or disclosure of any Confidential Information that the receiving party can establish by written documentation to:
|
|
(a)
|
have been publicly known prior to disclosure by the disclosing party of such information to the receiving party;
|
|
(b)
|
have become publicly known without fault on the part of the receiving party, subsequent to disclosure to the receiving party;
|
|
(c)
|
have been received by the receiving party at any time from a source, other than the disclosing party, lawfully having possession of and the right to disclose such information;
|
|
(d)
|
have been otherwise known by the receiving party prior to disclosure by the disclosing party to the receiving party of such information; or
|
|
(e)
|
have been independently developed by the receiving party without use of information disclosed by the disclosing party.
|
|
7.3
|
Required Disclosure. A party receiving Confidential Information may disclose such Confidential Information if required to do so by a court (or other governmental agency or stock exchange of competent jurisdiction), any governmental body or as required under any Applicable Laws; provided that (i) the party required to disclose such Confidential Information provides prompt notice of such pending disclosure to the disclosing party so that the disclosing party can seek a protective order or to prevent such disclosure, and (ii) the party required to disclose such Confidential Information shall exercise reasonable efforts to ensure that the information is accorded confidential treatment by the court or other governmental agency or stock exchange.
|
|
7.4
|
Survival of Confidentiality Obligations. The provisions of this Article 7 shall survive for a period of seven (7) years following the expiration or termination of this Agreement.
|
|
7.5
|
Injunctive Relief. Each party acknowledges that the failure by the Receiving Party to comply with any of the provisions of this Article 7 will result in irreparable injury and continuing damage to the disclosing party for which there will be no adequate remedy at law and that, in the event of a failure of the receiving party so to comply, the disclosing party shall be entitled to such preliminary and permanent injunctive relief as may be necessary to ensure compliance with all the provisions of this Article 7 without having to prove actual damages or to post a bond.
|
|
7.6
|
HIPAA Compliance. Notwithstanding anything to the contrary herein (including the Exhibits hereto), ICS shall only provide information to Dyax under this Agreement in a manner consistent with HIPAA, to the extent applicable. Accordingly, the parties agree that ICS shall only provide Dyax information that is de-identified in accordance with HIPAA's de-identification provision, 45 C.F.R. § 164.514(b)(2), unless Dyax: (i) has on file a valid, HIPAA-compliant authorization for each patient whose protected health information ("PHI") is sought to be disclosed; or (ii) authorization is not required under Applicable Laws in order to disclose the information sought.
|
8.
|
Use of Marks.
|
9.
|
Additional Representations, Warranties and Covenants.
|
|
9.1
|
Authorization. Each party represents and warrants to the other party that it has the legal right and power to enter into this Agreement, to extend the rights and licenses granted to the other in this Agreement, and to fully perform its obligations hereunder, and that the performance of such obligations will not conflict with its charter documents or any agreements, contracts, or other arrangements to which it is a party. Furthermore, no approvals, consents, orders or authorizations of or designation, registration, declaration or filing with any governmental authority (within the Field in the Territory) is required for either party's performance of its obligations under this Agreement, other than any approvals that have been obtained already or will be obtained in the ordinary course of the performance of such obligations.
|
|
9.2
|
Federal Programs. ICS represents, warrants and covenants to Dyax that (a) neither ICS nor any of its Affiliates that perform activities under this Agreement has been debarred or is subject to debarment pursuant to Section 306 of the Act or listed on either Excluded List (as defined herein), and (b) neither ICS nor any of its Affiliates that perform activities under this Agreement will knowingly (after reasonable investigation) use in any capacity, in connection with the services to be performed under this Agreement, any person who has been debarred pursuant to Section 306 of the Act, or who is the subject of a conviction described in such section, or listed on either Excluded List. ICS shall inform Dyax in writing immediately if it or any person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 of the Act or listed on either Excluded List, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of ICS's knowledge, is threatened, relating to the debarment or conviction Section 306 of the Act, or listing on either Excluded List, of ICS or any person performing services hereunder. "Excluded Lists" means the Department of Health and Human Service's List of Excluded Individuals/Entities and the General Services Administration's Lists of Parties Excluded from Federal Procurement and Non-Procurement Programs.
|
|
9.3
|
ICS/Licensure. ICS represents and warrants that it now has and shall maintain in full force during the Term all applicable federal and state wholesaler and other licenses or approvals required under Applicable Laws and regulations to fulfill its obligations under this Agreement in each state in the Territory, the District of Columbia and Puerto Rico. ICS promptly shall notify Dyax of any denials, revocations or suspension of license or registrations by any state or federal agency or any other regulatory authority in the Territory, or any written notice from a governmental body proposing such a denial, revocation or suspension of a license or registration. ICS shall promptly provide Dyax with notice of any material communications with wholesaler licensing boards which relate to potential problems with facilities, operations, contractors or procedures used by ICS in distribution of the Product, including notices of inquiries, investigations or inspections and resulting findings, except that in no event shall ICS be required to disclose information concerning its other clients or the products of such clients.
|
|
9.4
|
Dyax Representations and Warranties. Dyax hereby represents and warrants to ICS that, at the time of delivery of Product by Dyax to ICS hereunder: (a) such Product shall not in any material respect be adulterated, misbranded or otherwise prohibited within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et. seq., as amended and in effect at the time of delivery (the "Act"), or within the meaning of any applicable state or local law; (b) such Product will be merchandise that may be introduced and delivered into interstate commerce under the provisions of Section 301 of the Act or Section 351 of the Public Health Service Act; (c) Dyax has and will maintain, in full force and effect, all licenses and permits required under Applicable Laws for Dyax to sell and distribute such Product under this Agreement; (d) such Product will be the subject of a duly approved Biologics License Application and may be legally transported or sold under Applicable Laws; (e) such Product will have been approved by each applicable governmental authority for commercial sale and shipment of such Product within the Territory; and (f) Dyax either (i) owns or holds the duly approved Biologics License Application, as such term is used in the Public Health Service Act, Title 21, United States Code, as amended for such Product, or (ii) is otherwise considered the “manufacturer” of such Product within the meaning of any applicable federal, state or local law relating to pedigrees.
|
|
9.5
|
No Other Warranties. Except as expressly provided herein and in the Continuing Guaranty, neither party hereto makes any representations or warranties to the other party, express or implied, either in fact or by operation of law, by statute or otherwise, and each party specifically disclaims any express or implied representations and warranties of merchantability or fitness for a particular purpose.
|
10.
|
Liability, Indemnification and Insurance.
|
|
10.1
|
Remedies.
|
|
(a)
|
Generally. Rights and remedies under this Agreement are cumulative and in addition to any other available rights or remedies under any other agreement, at law or in equity.
|
|
(b)
|
Equitable Relief. If either party violates or threatens to violate any provision of this Agreement, the other party may suffer irreparable harm and its remedies at law may be inadequate. Accordingly, the other party may seek equitable relief.
|
|
10.2
|
Indemnification.
|
|
(a)
|
Indemnification by ICS. ICS shall indemnify, defend, and hold harmless Dyax and its Affiliates and its and their respective directors, officers, employees, representatives and agents and their respective successors, heirs and assigns (the "Dyax Indemnitees") against any liability, damage, loss, penalty, fine or expense (including reasonable attorneys fees and expenses of litigation) (collectively, "Losses") incurred by or imposed upon Dyax Indemnitees or any of them in connection with any claims, suits, demands, investigations, enforcement actions, or judgments, in each case initiated by a third party (including any governmental or regulatory agency) (collectively, "Third Party Claims") which arise out of: (a) the gross negligence or willful misconduct of ICS in connection with this Agreement; or (b) the breach of this Agreement by ICS, in each case except for those Losses for which Dyax has an obligation to indemnify ICS pursuant to Section 10.2(b), as to which Losses each party shall indemnify the other to the extent of its respective liability for such Losses.
|
|
(b)
|
Indemnification by Dyax. Dyax shall indemnify, defend, and hold harmless ICS and its Affiliates and its and their respective directors, officers, employees, representatives and agents and their respective successors, heirs and assigns (the "ICS Indemnitees") against any Losses incurred by or imposed upon ICS Indemnitees or any of them in connection with any Third Party Claims which arise out of: (a) the negligence or willful misconduct of Dyax in connection with this Agreement; (b) the breach of this Agreement by Dyax, (c) claims of patent, trademark, copyright or other infringement related to Products, or (d) storage, handling, use, non-use, demonstration, consumption, ingestion, digestion, manufacture, production and assembly of Products and their transportation to ICS (except to the extent that such activities are actually conducted by ICS), in each case except for those Losses for which ICS has an obligation to indemnify Dyax pursuant to Section 10.2(a), as to which Losses each party shall indemnify the other to the extent of its respective liability for such Losses.
|
|
(c)
|
Indemnification Procedure. A party that intends to claim indemnification under this Section 10.2 (the "Indemnitee") shall: (i) promptly notify the indemnifying party (the "Indemnitor") in writing of any Third Party Claim in respect of which the Indemnitee or any of its Affiliates or any of their respective directors, officers, employees, representatives, agents or their respective successors, heirs or assigns intend to claim such indemnification hereunder; (ii) provide the Indemnitor sole control of the defense and/or settlement thereof with counsel reasonably satisfactory to the Indemnitee; provided, however, that the Indemnitee reserves the right to retain its own counsel to defend itself in, but not control the defense of, such suit, at its own expense, unless (a) the interests of the Indemnitee and the Indemnitor in the suit conflict in such a manner and to such extent as to require, consistent with applicable standards of professional responsibility, the retention of separate counsel for the Indemnitee, in which case, the Indemnitor shall pay for one separate counsel chosen by the Indemnitee or (b) the Indemnitor shall not have employed attorneys reasonably satisfactory to the Indemnitee to defend any action within a reasonable time after notice of commencement of such action and (iii) provide the Indemnitor, at the Indemnitor's request and expense, with reasonable assistance and full information with respect thereto. Neither the Indemnitor nor the Indemnitee shall be responsible to or bound by any settlement made by the other without its prior written consent, which shall not be unreasonably withheld or delayed. Without limiting the foregoing provisions of this Section 10.2(c), the Indemnitor shall keep the Indemnitee reasonably informed of the progress of any claim, suit or action under this Section 10.2 and the Indemnitee shall have the right to participate in any such claim, suit or proceeding with counsel of its choosing at its own expense, but the Indemnitor shall have the sole right to control the defense or settlement thereof in accordance with the terms of this Section 10.2(c).
|
|
10.3
|
Limitation of Liability.
|
|
(a)
|
Neither party shall be liable to the other for special, exemplary, consequential, incidental (including lost or anticipated revenues or profits), indirect or punitive damages arising from the performance or nonperformance of such party under this Agreement whether such claim is based on contract, tort (including negligence) or otherwise, even if an authorized representative of such party is advised of the possibility or likelihood of same.
|
|
(b)
|
Notwithstanding the exclusions and limitations of liability set forth in Section 10.3(a) above, such exclusions and limitations shall not apply to: (i) either party's indemnification obligations pursuant to Section 10.2; or (ii) either party's breach of the party's confidentiality obligations pursuant to Article 7.
|
|
(c)
|
Any loss due to damage or loss of Products will be based upon Dyax's cost of manufacturing or acquiring products, not it's selling cost.
|
|
10.4
|
ICS Insurance Obligations. During the Term, ICS shall maintain appropriate levels of insurance for the risks assumed under this Agreement, including the following minimum levels of insurance:
|
|
(a)
|
Employer's liability insurance with a limit of [*****] for bodily injury by accident per person, [*****] for bodily injury by accident, all persons and [*****] bodily injury by disease policy limit;
|
|
(b)
|
Commercial general liability insurance, including personal injury blanket contractual liability and broad form property damage, with a [*****] combined single limit;
|
|
(c)
|
Umbrella liability insurance in the amount of [*****] per occurrence and aggregate; and
|
|
10.5
|
Dyax Insurance Obligations. During the Term, Dyax will maintain property, products liability and commercial general liability insurance having a limit of not less than [*****] per occurrence, Combined Single Limit (Bodily Injury and Property Damage), pursuant to one or more insurance policies with reputable insurance carriers having a Best’s Rating of A VII or otherwise as reasonably approved by ICS. Dyax will designate ICS as an "additional insured" under such insurance policy and will obtain a broad form vendor’s endorsement for products liability for ICS. Within thirty (30) days after the Effective Date, Dyax will provide to ICS a certificate of insurance indicating that such obligations have been satisfied. As a condition precedent to the effectiveness of this Agreement, Dyax will execute the form of Continuing Guaranty and Indemnification Agreement (the “Continuing Guaranty”) with AmerisourceBergen Corporation attached hereto as Exhibit D.
|
11.
|
Terms and Termination.
|
|
11.1
|
Term. Unless earlier terminated in accordance with the terms hereof, the term of this Agreement (the "Term") shall (i) commence as of the Effective Date and will continue in effect for an initial period of three (3) years (the "Initial Term"), and (ii) automatically renew for subsequent periods of two (2) years (each, a "Renewal Term"), unless either party provides written notice to the other at least three (3) months prior to the end of the Initial Term or then-current Renewal Term that it does not wish to renew. The parties will work together in good faith to discuss and agree upon any appropriate fee adjustments at least three months prior to expiration of the Initial Term.
|
|
11.2
|
Termination. In addition to any other provision of this Agreement providing for termination hereof, this Agreement may be terminated as follows:
|
|
(a)
|
Termination by Dyax For Convenience. Dyax may terminate this Agreement for convenience, without cause, upon six (6) months’ prior written notice of termination to ICS.
|
|
(b)
|
Termination For Cause. This Agreement may be terminated by either party on written termination notice to the other party in the event of any material breach of this Agreement by the other party (other than a breach by ICS of Section 3.2, which is governed by clause (ii) below), which breach is not cured within [*****] (or [*****] for any breach relating to payment obligations under this Agreement) after delivery of written notice by the non-breaching party specifying such breach and requiring cure. Notwithstanding the right to cure provided by the foregoing sentence, ICS shall have the right to cure only two (2) material breaches of any particular obligation hereunder, and this Agreement may be terminated by Dyax immediately on written notice to ICS in the event of any additional material breach of such obligation by ICS.
|
|
(c)
|
Insolvency. This Agreement may be terminated by either party immediately upon written notice to the other party in the event of any of the following events:
|
|
(i)
|
the institution by the other party of insolvency, receivership or bankruptcy proceedings or any other material proceedings for the settlement of the other party's debts, or the institution against the other party of any such proceedings that remain undismissed for ninety (90) days;
|
|
(ii)
|
the other party's making an assignment for the benefit of its creditors; or
|
|
(iii)
|
the other party's dissolution.
|
|
(d)
|
Other Agreements. In the event that any of (a) the Distribution Services Agreement of even date herewith between Dyax and ASD Specialty Healthcare, Inc. or (b) the Distribution Services Agreement of even date herewith between Dyax and US Bioservices Corporation is terminated for any reason, then (i) this Agreement may be terminated by Dyax upon [*****] written notice to ICS; and (ii) if not terminated, ICS will notify Dyax of any applicable adjustment to Fees based upon such termination.
|
|
(i)
|
This Agreement shall terminate if both: (A) as a result of the enactment of any new applicable federal or state law or regulation, or any change in any existing applicable federal or state law or regulation or any new interpretation of any applicable federal or state law or regulation by any legislative body, court or regulatory agency, the performance by a party of any material obligation under the Agreement would be rendered illegal or any material provision of the Agreement would be rendered invalid or unenforceable, and (B) the parties are unable to negotiate a mutually acceptable amendment to the Agreement pursuant to Section 11.2(e)(iii) below. If any immaterial provision of this Agreement is held to be illegal, invalid or unenforceable for any reason, the Agreement shall be deemed amended to delete such provision, such amendment to apply only with respect to the operation of the Agreement in the particular jurisdiction in which such provision is held to be illegal, invalid or unenforceable, and the remainder of the Agreement shall remain in full force and effect and enforceable in accordance with its terms.
|
|
(ii)
|
The parties agree that the party affected by the new law or regulation or the change in law or regulation or the interpretation of a law or regulation shall use reasonable efforts to give the other party at least [*****] prior written notice of the effective date of such new law, change, or interpretation.
|
|
(iii)
|
The parties agree that, notwithstanding the foregoing provisions of this Section, either party may, within ten (10) business days of giving or receiving notice of the new law, change or interpretation, notify the other party of its wish to renegotiate the applicable terms of the Agreement ("Renegotiation Notice"), in which event the parties shall negotiate in good faith, for a period of sixty (60) days from delivery of the Renegotiation Notice, an amendment to the Agreement that addresses the portion of the Agreement rendered illegal, invalid or unenforceable by the new law, change or interpretation while preserving to the greatest extent possible the original intent of the Agreement. If the parties successfully conclude such negotiations prior to the effective date of the new law, change or interpretation, the Agreement shall not terminate and shall be amended to reflect the negotiated terms. If the parties are unable to successfully conclude such negotiations prior to the effective date of the new law, change or interpretation and such effective date is within the sixty (60) day negotiation period, the Agreement shall be deemed amended to delete such portion rendered illegal, invalid, or unenforceable, such amendment to apply only with respect to the operation of the Agreement in the particular jurisdiction in which such portion is held to be illegal, invalid or unenforceable, and the remainder shall remain in full force and effect and enforceable in accordance with its terms. In the event the parties are unable to successfully conclude such negotiations within the sixty (60) day negotiation period, the Agreement shall terminate at the end of the sixty (60) day negotiation period.
|
|
(a)
|
all Confidential Information received hereunder shall be returned to the disclosing party, or destroyed, at the disclosing party's election (provided that the receiving party may retain one copy to the extent necessary to comply with any contractual or other legal obligations applicable thereto);
|
|
(b)
|
all rights granted to ICS with respect to the Product shall terminate and ICS shall follow Dyax’s reasonable instructions to cease in a timely and orderly manner all activities with respect to the selling and distribution of Product; and
|
|
(c)
|
unless terminated by ICS pursuant to Section 11.2 above (Material Breach) for a period of [*****] following such expiration or early termination, ICS and its Affiliates shall provide commercially reasonable assistance in connection with Dyax's transition of Product distribution and Hub Services to Dyax, its Affiliates or any third party selected by Dyax. Dyax shall reimburse ICS for its reasonable, documented out-of-pocket costs and expenses incurred with in connection with providing such transition services; provided that, in the event of a termination due to ICS's breach, neither the existence of this provision nor the fact of Dyax's agreement to pay for such transition services shall in any way effect or limit Dyax's rights or remedies with respect to such breach.
|
|
(d)
|
If Dyax terminates this Agreement pursuant to Section 11.2(a) or ICS terminates this Agreement pursuant to Section 11.2(b) prior to the first anniversary of the Effective Date, Dyax shall pay ICS an early termination fee, with the amount being equal to $110,000. The Early Termination Fee is intended to compensate ICS for development costs related to the Services hereunder and is in addition to, not in lieu of, any other amounts it is entitled to under this Agreement or at law.
|
|
11.4
|
Termination of Exclusivity. In the event that Dyax has the right to terminate this Agreement, Dyax, on immediate written notice to ICS, may terminate Section 2.3, which shall have no further force or effect from and after the delivery of such notice by Dyax.
|
12.
|
Dispute Resolution.
|
|
12.1
|
Resolution by Executives. Any dispute, controversy or claim initiated by either party arising out of, or resulting from the breach or alleged breach by either party of its obligations under this Agreement (other than bona fide third party actions or proceedings filed or instituted in an action or proceeding by a third party against a party to this Agreement), whether before or after termination of this Agreement, shall be in the first instance referred to the respective chief executive officers of the parties unless such dispute or claim must be filed to preserve a legal interest or injunctive relief is required.
|
|
12.2
|
Arbitration. If chief executive officers (or their representatives, it being agreed that the chief executive officer of either party may designate a representative, provided such representative is empowered with decision making in the dispute) of the parties fail to resolve any dispute as provided in Section 12.1 within [*****], then such dispute shall be finally resolved by binding arbitration as follows:
|
|
(a)
|
Any dispute that might arise between the parties relating to or arising from this Any dispute that might arise between the parties relating to or arising from this Agreement shall be settled by binding arbitration in accordance with the then-prevailing Commercial Arbitration Rules of the American Arbitration Association (“AAA”), except where those rules conflict with this provision, in which case this provision controls. Arbitration shall be conducted before a single arbitrator selected from the AAA’s National Roster of Arbitrators, each of whom shall be a lawyer with at least 15 years experience with a law firm or corporate law department of over 25 lawyers or who was a judge of a court of general jurisdiction. Each party shall have the right to meet and interview the potential arbitrator for no more than one hour each prior to the selection of an arbitrator. The arbitration shall be held, and Dyax and ICS irrevocably consent to arbitrate, in New York, NY, unless they mutually agree upon an alternative location. The arbitration shall be conducted in English. In rendering the award the arbitrator must apply the substantive law of the State of Delaware (except where that law conflicts with this clause); however, the interpretation and enforcement of this arbitration provision shall be governed by the Federal Arbitration Act. The arbitrator shall render a written opinion setting forth findings of fact and conclusions of law with the reasons therefor stated. Under no circumstances shall the arbitrator award damages in excess of or inconsistent with any limitations of liability contained in this Agreement. Any court with jurisdiction shall enforce this clause and enter judgment on any award. ICS and Dyax will agree upon, within [*****] days after the arbitrator is selected or, if they fail to agree, the AAA will design, procedures that they will follow to assure that the arbitration will be concluded and the award rendered within no more than eight months from selection of the arbitrator.
|
|
(b)
|
The arbitration proceedings shall be confidential, and neither party shall publicize the nature of any dispute or the outcome of any mediation or arbitration proceedings except to the extent required by law, provided in such case the party required to make any disclosure informs the other party of such requirement to allow the other party to seek a protective order. The mediator or arbitrator, as the case may be, shall issue appropriate protective orders to safeguard each party’s confidential information.
|
|
(c)
|
Each party has the right before or during the mediation or arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, an injunction, replevin, etc., to avoid irreparable harm, maintain the status quo or preserve the subject matter of the arbitration.
|
13.
|
Miscellaneous.
|
|
13.1
|
Relationship of Parties. ICS's relationship with Dyax hereunder shall be that of independent contractor, and neither party shall be considered the agent of, partner of, employee or other member of the workforce of, or participant in a joint venture with, the other party. Neither party shall have authority to bind the other party unless otherwise agreed to in writing by such parties.
|
|
13.2
|
Notices. All notices, requests, demands and other communications required or permitted to be given pursuant to this Agreement shall be in writing and shall be deemed to have been duly given upon the date of receipt if delivered by hand, recognized international overnight courier, confirmed facsimile transmission, or registered or certified mail, return receipt requested, postage prepaid to the following addresses or facsimile numbers:
|
If to Dyax:
|
Dyax Corp.
|
300 Technology Square
|
|
Cambridge, MA 02139
|
|
[*****]
|
|
If to ICS:
|
AmerisourceBergen Specialty Group
|
3101 Gaylord Parkway
|
|
Frisco, TX 75034
|
|
[*****]
|
|
13.3
|
Assignment. Neither party may assign its rights or delegate its obligations under this Agreement without the prior written consent of the other party, except that either party may assign this Agreement to any of its Affiliates or to a successor in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement, with prompt written notice to the other party of any such assignment; provided that: (i) if such assignee is an Affiliate, the assignor shall be responsible for and liable with respect to all assigned obligations and (ii) if such assignee is not an Affiliate, (A) the assignee assumes the assignor’s obligations under the Continuing Guaranty and Indemnification Agreement, and (B) the assignee has net assets as of the end of its most recently completed fiscal year equal to or in excess of the net assets of the assignor as of the end of its most recently completed fiscal year, in each case as set forth in the audited balance sheet of the assignor and assignee, and (iii) in the case of an assignment by Dyax, the assignee is not a Competitor to ICS. For the purposes of this Section 13.3, a “Competitor” means any organization, entity or person that competes with ICS including but not limited to the following companies and their affiliated entities: [*****].
|
|
13.4
|
Force Majeure. Each party's obligation under this Agreement will be excused to the extent any delay or nonperformance is caused by strikes or other labor disturbance, acts of God, war, or other conditions beyond the reasonable control of that party, but only during the duration of such condition.
|
|
13.5
|
Amendment and Waiver. This Agreement may be amended, supplemented, or otherwise modified only by means of a written instrument signed by both parties. Any waiver of any rights or failure to act in a specific instance shall relate only to such instance and shall not be construed as an agreement to waive any rights or fail to act in any other instance, whether or not similar. To be valid, any waiver must be in writing.
|
|
13.6
|
Severability. In the event any provision of this Agreement should be held invalid, illegal or unenforceable, the remaining provisions shall not be affected or impaired and the parties shall use all reasonable efforts to replace the applicable provision with a valid, legal and enforceable provision which insofar as practical implements the original intent of such invalid, illegal or unenforceable provision, provided, however, that if the parties fail to reach such agreement within sixty (60) days, a party whose rights or obligations are materially adversely affected as a result of a provision being held invalid, illegal or unenforceable may terminate this Agreement.
|
|
13.7
|
Headings. All headings used in this Agreement are inserted for convenience only and are not intended to affect the meaning or interpretation of this Agreement or any Article or Section hereof.
|
|
13.8
|
Successors and Assigns. This Agreement shall be binding on and shall benefit any and all successors, trustees, permitted assigns and other successors in interest of the parties.
|
|
13.9
|
Applicable Law; Disclaimer of Puerto Rico Law 75.
|
|
(a)
|
This Agreement shall be construed and enforced in accordance with the laws of the State of Delaware (excluding the choice of law provisions thereof).
|
|
(b)
|
The parties expressly disclaim, to the fullest extent allowed by Applicable Law, any application of the Puerto Rico Dealers Act, Law No. 75 of June 1964 (the "Dealers Act") as amended, and the parties acknowledge that the Dealers Act shall not apply in the interpretation or enforcement of any of the rights and obligations of the parties hereto.
|
|
13.10
|
Contract Interpretation. The parties have jointly negotiated this Agreement and, thus, neither this Agreement nor any provision will be interpreted for or against any party on the basis that it or its attorney drafted the Agreement or the provision at issue. When this Agreement requires approval of one or more parties, such approval may not be unreasonably withheld or delayed. Words, regardless of the number and gender specifically used, will be construed to include any other number, singular or plural, and any gender, masculine, feminine, or neuter, as the context requires. "And" includes "or." "Or" is disjunctive but not necessarily exclusive. "Including" means "including but not limited to." Unless other specifically stated, the term "days" means calendar days.
|
|
13.11
|
Entire Agreement; No Reliance. Each of the parties agrees and acknowledges that this Agreement, including the Continuing Guaranty and attachments referred to herein, (i) constitutes the entire agreement and supersedes all prior and contemporaneous agreements, understandings, negotiations and discussions, whether oral or written, between the parties with respect to the subject matter of this Agreement, and (ii) is not intended to confer any rights or remedies, or impose any obligations, on any person other than the parties hereto. Each of the parties expressly agrees and acknowledges that, other than those statements expressly set forth in this Agreement, it is not relying on any statement, whether oral or written, of any person or entity with respect to its entry into this Agreement or to the consummation of the transactions contemplated by this Agreement.
|
|
13.12
|
Counterparts. This Agreement may be executed in multiple counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. Facsimile execution and delivery of this Agreement are legal, valid and binding execution and delivery for all purposes.
|
Integrated Commercialization Solutions, Inc.
|
Dyax Corp.
|
|||
By:
|
/s/ Douglas Cook
|
By:
|
/s/ Ivana Magovcevic-Liebisch
|
|
Name:
|
Douglas Cook
|
Name:
|
Ivana Magovcevic-Liebisch
|
|
Title:
|
VP, Distribution Services
|
Title:
|
Executive Vice President Corporate
Development and General Counsel |
AmerisourceBergen Specialty Group, Inc.
|
|||
By:
|
/s/ Mike Mullen
|
||
Name:
|
Mike Mullen
|
||
Title:
|
President
|
Product Trade Name:
|
Kalbitor®
|
Generic Name:
|
ecallantide
|
NDC Number:
|
47783-101-01
|
DYAX CORP.
|
/s/Ivana Magovcevic-Liebisch
|
11/19/09
|
||
Guarantor's Company Name
|
Signature of Authorized Officer
|
Date
|
||
Ivana Magovcevic-Liebisch, EVP Corporate Development
|
||||
Name and Title
|
||||
300 Technology Square, Cambridge, MA 02139
|
||||
Address of Company
|
||||
Revised
|
(617) 225-2500
|
|||
6/2/05
|
Phone
|
(I_%GB[Q'K/P`TO]H.U^!.IVWB;7[F>_UWPU>_#B;PIJ@D:SO-
M#FL<6HNBZ<,QPF*DI_5:&4O`SP\W#$*6-ABN')TL?6I.&'HXV<\-EV<0KMK"
M5/:8Y1C-TL3BE`KOGR66`BHO'2KY/5EC(IX: