EX-10.17 18 a2217789zex-10_17.htm EX-10.17 [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities...
Exhibit 10.17
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
DEVELOPMENT AND LICENSE AGREEMENT
This Development and License Agreement (“AGREEMENT”) is made effective as of March 18, 2008 (the “EFFECTIVE DATE”) by and between Xxxxxx One, LLC, having its principal place of business at 000 Xxxxxxxxxx Xxxx, Xxxxxxx, XX 00000 (“XXXXXX”), and Eagle Pharmaceutical, Inc. having its principal place of business at 000 Xxxxxxxx Xxxxx Xxxx, Xxxxxxxxx Xxxx, XX 00000 (“EAGLE”). XXXXXX and EAGLE may be referred to herein individually as a “PARTY” and collectively as the “PARTIES.”
1.1 “505(b)(2)” means a 505(b)(2) Application filed with the FDA, or any foreign equivalent filed with the FDA to obtain MARKETING AUTHORIZATION for the PRODUCT in such country.
1.2 “AFFILIATE” means, with respect to any other person or entity, any other person or entity that directly or indirectly controls, is controlled by, or is under common control with, such person or entity. For purposes of this definition only, “control,” “controlled by” and “under common control with” shall mean the possession of the power to direct or cause the direction of the management and policies of an entity, whether through the ownership of voting stock or partnership interest, by contract or otherwise. In the case of a corporation, the direct or indirect ownership of fifty percent (50%) or more of its outstanding voting shares or the ability otherwise to elect a majority of the board of directors or other managing authority of the entity shall in any event be deemed to confer control, it being understood that the direct or indirect ownership of a lesser percentage of such shares shall not necessarily preclude the existence of control.
1.3 “ANDA” means any abbreviated new drug application required to manufacture, market and sell finished dosage forms of the PRODUCTS in the Territory filed by EAGLE with the FDA pursuant to 21 USC Section 355(j), and any supplements and amendments thereto that may be filed by EAGLE from time to time.
1.4 “ASSIGNED PATENTS” means (i) the PATENT APPLICATIONS set forth in Schedule I, all PATENT APPLICATIONS claiming priority to such PATENT APPLICATIONS, any of their progeny and any PATENTS issuing from, directly or indirectly, or based upon any of the foregoing, and (ii) the inventions described or claimed in any of the foregoing.
1.5 “CLAIMS” has the meaning set forth in Section 9.1.1.
1.6 “COMPETING PRODUCT” means a ANDA or a 505(b)(2) pharmaceutical product that has the same active ingredient, and that is indicated for the treatment of the same indication, as a PRODUCT.
1.7 “CONFIDENTIAL INFORMATION” has the meaning set forth in Section 6.1.
1.8 “CONTROL(LED)” means the ability to grant a license or sublicense as provided for herein without violating the terms of any agreement or other arrangement with any THIRD PARTY.
1.9 “COST OF GOODS” means, in respect of any PRODUCT, the amount paid by EAGLE to its contract manufacturer for the manufacturing and release of such finished PRODUCT including the cost of the active pharmaceutical ingredient, raw materials and packaging materials used in such finished PRODUCT.
1.10 “DEFAULT” has the meaning set forth in Section 8.2.4.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
1.11 “DEVELOPMENT ACTIVITIES” means any and all actions reasonably necessary or required, that are agreed to upon by the DEVELOPMENT COMMITTEE, to formulate, analytically develop, and validate a PRODUCT.
1.12 “DISCLOSING PARTY” means the PARTY disclosing CONFIDENTIAL INFORMATION to the other PARTY hereunder.
1.13 “DOLLAR(S)” means United States dollars.
1.14 “FDA” means the United States Food and Drug Administration, or any successor entity that may be established hereafter which has substantially the same authority or responsibility currently vested in the United States Food and Drug Administration.
1.15 “FIRST COMMERCIAL SALE” means, with respect to a PRODUCT, the first sale by EAGLE or its LICENSEES to a THIRD PARTY following receipt of a MARKETING AUTHORIZATION for such PRODUCT; provided, however, that the PRODUCT shipped by EAGLE or its LICENSEES to a THIRD PARTY prior to receipt of MARKETING AUTHORIZATION therefor shall be deemed for the purposes hereof a FIRST COMMERCIAL SALE to the extent such PRODUCT is sold to a THIRD PARTY for sale after such MARKETING AUTHORIZATION is obtained.
1.16 “GROSS PROFIT” means NET SALES minus COST OF GOODS minus SALES FORCE COSTS.
1.17 “GROSS PROFIT MARGIN” means the fraction, expressed as a percentage, the numerator of which is the GROSS PROFIT and the denominator of which is the NET SALES.
1.18 “EAGLE INDEMNITEE” has the meaning set forth in Section 9.1.1.
1.19 “EAGLE KNOW-HOW” means all KNOW-HOW CONTROLLED by EAGLE that is necessary or useful for XXXXXX in connection with ROBERT’S performance of its obligations under this AGREEMENT. EAGLE PATENT RIGHTS are excluded from the definition of EAGLE KNOW-HOW.
1.20 “EAGLE PATENT RIGHTS” means all PATENTS and PATENT APPLICATIONS CONTROLLED by EAGLE that are necessary for XXXXXX in connection with ROBERT’S performance of its obligations under this AGREEMENT.
1.21 “INVENTIONS” means any and all ideas, concepts, methods, procedures, processes, improvements, inventions and discoveries, whether or not patentable, that are conceived or made in the course of the performance of activities
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
conducted in connection with this AGREEMENT including the development or manufacture of the PRODUCTS.
1.22 “JOINT INVENTION” has the meaning set forth in Section 10.3.
1.23 “JOINT PATENT APPLICATIONS” has the meaning set forth in Section 10.5.
1.24 “KNOW-HOW” means all technical, scientific and other know-how, data, materials, information, trade secrets, ideas, formulae, inventions, discoveries, processes, machines, manufactures, compositions of matter, improvements, protocols, techniques, works of authorship, and results of experimentation and testing (whether or not patentable) in written, electronic, oral or any other form.
1.25 “LAW(S)” means any applicable local, state or federal rule, regulation, statute or law in any jurisdiction relevant to the activities undertaken pursuant to this AGREEMENT.
1.26 “LICENSEE” means any person or entity, including EAGLE AFFILIATES, to which EAGLE grants a license under the ASSIGNED PATENTS or LICENSED XXXXXX TECHNOLOGY to sell, have sold and/or import the PRODUCT.
1.27 “MARKETING AUTHORIZATION” means, with respect to either PRODUCT, the requisite governmental approval (i.e., ANDA or 505(b)(2) or equivalent) for the marketing and sale of such PRODUCT in the TERRITORY.
1.28 “NET SALES” means, with respect to any PRODUCT, the amount invoiced by (or in the absence of an invoice, the amounts payable to) EAGLE or its AFFILIATES for the sale to THIRD PARTIES of such PRODUCT less the following: (i) customary administration fees, drug wholesaler fees, charge-backs, rebates (including Medicaid, Medicare and similar rebates) and trade and customary quantity discounts actually allowed and taken, including shelf stock adjustments, cash and volume discounts, chargebacks, promotional allowances, inventory obsolescence; (ii) allowances whether paid or accrued for returned PRODUCT; (iii) documented freight, postage, shipping costs and insurance paid by EAGLE (if separately stated); (iv) government-mandated and other rebates customary in the industry; (v) value added tax, sales, use or turnover taxes, excise taxes and customs duties and (vi) if applicable, expenses related to (A) PRODUCT recalls in accordance with Section 7.4, (B) infringement litigation in accordance with Sections 11.1.3, 11.2.2(b) and/or 11.2.3(a), and (C) marketing costs (other than SALES FORCE COSTS) directly related to the PRODUCTS (or, as applicable, the REPLACEMENT PRODUCTS related thereto). NET SALES shall be deemed to accrue upon the date of the invoice for the PRODUCT. In addition, NET SALES by EAGLE hereunder are subject to the following, as accrued on EAGLE’s book in good faith:
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(a) In the case of pharmacy incentive programs, hospital performance incentive program, charge backs, disease management programs, similar programs or discounts on “bundles” of products, all discounts and the like shall be allocated proportionately based on sales of comparable products to THIRD PARTIES on a standalone basis; and
(b) In the case of any sale or other disposal of the PRODUCT by EAGLE to an AFFILIATE for resale, the NET SALES shall be calculated as above on the value charged or invoiced on the first arm’s length sale to a THIRD PARTY;
(c) All accruals will be made in accordance with United States Generally Accepted Accounting Principles “US GAAP”.
1.29 “PATENT” means: (i) any letters patent and utility models including any extension, substitution, registration, confirmation, reissue, supplemental protection certificate, re-examination or renewal thereof; and (ii) to the extent valid and enforceable rights are granted by a governmental authority thereunder, a PATENT APPLICATION.
1.30 “PATENT APPLICATION” means an application for letters patent, including a provisional application, converted provisional application, continuation application, a continued prosecution application, a continuation-in-part application, a divisional application, a re-examination application, and a reissue application, including the applications listed on Schedule 1 hereto.
1.31 “PERSON” means any natural person, corporation, company, partnership, limited partnership, limited liability company, firm, association, trust, government, governmental agency, or any other entity, whether acting in an individual, fiduciary or other capacity.
1.32 “PRODUCT(S)” means five (5) ANDA or 505(b)(2) products as set forth in Exhibit A. A product will be considered a PRODUCT if the product feasibility, formulation and 1 month stability are deemed acceptable by the DEVELOPMENT COMMITTEE.
1.33 “PRODUCT FAILURE” means, in respect of a PRODUCT, (i) rejection by the FDA of the filing of the ANDA or 505(b)(2) application, (ii) failure to receive MARKETING AUTHORIZATION by the FDA following such application filing or (iii) the failure to complete the milestone in respect of such PRODUCT set forth in Schedule III within thirty (30) days of the date set forth on Schedule III (as the same may be extended by Agreement of the PARTIES).
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
1.34 “RECIPIENT” means the PARTY receiving CONFIDENTIAL INFORMATION hereunder.
1.35 “REPLACEMENT PRODUCT” means a ANDA or 505(b)(2) PRODUCT, as selected by the DEVELOPMENT COMMITTEE to replace either PRODUCT which is subject to the PRODUCT FAILURE.
1.36 “RESPONSIBLE PARTY” has the meaning set forth in Section 10.5.
1.37 “ROYALTY RATE” means [*] with respect to a 505(b)(2) application and [*] with respect to an ANDA application.
1.38 “ROYALTY TERM” means, with respect to a PRODUCT, the period of time commencing on [*] and expiring upon the later of: (a) [*] thereafter; and (b) [*].
1.39 “SALES FORCE COSTS” means the costs of any hospital sales force hired to market and sell the PRODUCTS (provided, however, that Eagle shall have no obligation to hire a hospital sales force for the marketing and selling the PRODUCTS).
1.40 “XXXXXX INDEMNITEE” has the meaning set forth in Section 9.1.2.
1.41 “XXXXXX KNOW-HOW” means all existing and future KNOW-HOW owned or CONTROLLED by XXXXXX, that is necessary or useful for EAGLE to develop, make, have made, use, offer for sale, sell, have sold and import the PRODUCT. XXXXXX PATENT RIGHTS are excluded from the definition of XXXXXX KNOW-HOW.
1.42 “XXXXXX LICENSED TECHNOLOGY” means, collectively, the XXXXXX PATENT RIGHTS and the XXXXXX KNOW-HOW, excluding the ASSIGNED PATENTS.
1.43 “XXXXXX PATENT RIGHTS” means all of the existing and future PATENTS and PATENT APPLICATIONS owned or CONTROLLED by XXXXXX which claim the composition, development, manufacture, offer for sale, sale, import or use of the PRODUCTS, and that are necessary or useful to develop, make, have made, use, sell, have sold or import the PRODUCTS.
1.44 “SOLE INVENTION” has the meaning set forth in Section 10.3.
1.45 “SUBLICENSEE” means any person or entity, including its AFFILIATES, to which EAGLE grants a sublicense to sell, have sold and/or import the PRODUCTS pursuant to the license set forth in Section 2.2.
1.46 “TERM” has the meaning set forth in Section 13.1.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
1.47 “TERRITORY” means worldwide (excluding China) for 505(b)(2) PRODUCT applications, however, TERRITORY means only North America (including the United States, its territories and possessions and Canada) for ANDA PRODUCT applications
1.48 “THIRD PARTY” means any entity other than XXXXXX, EAGLE and their respective AFFILIATES.
1.49 “VALID PATENT CLAIM” means either: (a) a claim of an issued and unexpired PATENT that is included in the ASSIGNED PATENTS or the XXXXXX LICENSED TECHNOLOGY and covering the manufacture, use, import or sale of a PRODUCT, which PATENT has not (i) expired or been canceled with prejudice, (ii) been declared invalid by an irreversible and unappealable decision of a court or other appropriate body of competent jurisdiction, (iii) been admitted to be invalid or unenforceable through reissue, disclaimer, or otherwise, or (iv) been abandoned; or (b) a claim filed and kept pending in good faith that is included in a PATENT APPLICATION that is included in the ASSIGNED PATENTS or the XXXXXX LICENSED TECHNOLOGY and covering the manufacture, use, import or sale of the PRODUCT, which PATENT APPLICATION has not been (i) cancelled with prejudice, (ii) withdrawn from consideration without the ability to resubmit or re-file, (iii) finally determined to be unallowable by the applicable governmental authority, or (iv) abandoned.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
improvement to the PRODUCTS, to the extent permitted by ROBERT’s agreement with the licensor, XXXXXX shall promptly notify EAGLE of such technology and offer EAGLE the use of such technology to the greatest extent permitted by such agreement. In the event that EAGLE elects, in its sole discretion, to use such technology, then the PARTIES shall negotiate in good faith a commercially reasonable amount that EAGLE will reimburse XXXXXX, which amount shall represent a portion of any fees that XXXXXX must pay under such agreement, based on EAGLE’s proportional use under the license in connection with the PRODUCTS as compared to ROBERT’s aggregate use under the license for any purpose.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
to the other PARTY any inventions made through use or practice of such PARTY’S intellectual property rights outside the scope of the license rights granted hereunder.
3. Milestones; Royalty Payments; Royalty Reports; PRODUCT Selection;
3.1.1 EAGLE shall pay to XXXXXX the milestone payments in accordance with and on the dates provided in Schedule II hereto.
3.1.2 In the event of a PRODUCT FAILURE, then, subject to Sections 3.1.3, 3.1.4 and 4.1.3, XXXXXX shall be obligated to refund to EAGLE an amount equal to the portion of all milestone payments paid by EAGLE and allocated to the applicable PRODUCT. In the event of a PRODUCT FAILURE with respect to a PRODUCT prior to payment of all milestone payments, future milestone payments in respect of such PRODUCT, if any, shall be allocated towards a REPLACEMENT PRODUCT. For the sake of clarity, in the event that PARTIES select a REPLACEMENT PRODUCT, in no event shall EAGLE’s commitment for milestone payments to XXXXXX be more than the total milestones payable in Schedule II
3.1.3 In the event XXXXXX does not repay any amounts to be refunded by it by the later of December 31, 2010 or the date of the milestone failure, XXXXXX shall issue to EAGLE a promissory note in the principal amount of the unpaid amounts which shall be due and payable on December 31, 2014. Interest on the unpaid principal portion of such note shall accrue at the rate of [*] per year and shall be due and payable with all unpaid interest on the maturity date. Principal and interest under the note may be pre-paid at anytime without premium or penalty. Upon repayment in full of such amount, (i) the license granted pursuant to this Agreement with respect to the LICENSED TECHNOLOGY for the failed PRODUCT shall terminate and EAGLE shall assign the ASSIGNED PATENTS related solely to the failed PRODUCT to XXXXXX and (ii) the license granted by EAGLE pursuant to Section 2.5 of this Agreement for the failed PRODUCT shall terminate.
3.1.4 Notwithstanding any other provisions the provisions of this Section 3.1, all milestone in respect of either PRODUCT, shall be deemed met and no refund of any milestone payment shall be payable to EAGLE in the event that, as of December 31, 2010, payments are received from any THIRD PARTY with respect to such PRODUCT which results in payment to EAGLE of at least [*]. In the event that, as of December 31, 2010,
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
payments are received in respect of either PRODUCT from THIRD PARTIES from such PRODUCT which total in the aggregate less than [*], the amount to be refunded to EAGLE pursuant to Section 3.1.2 shall be reduced by an amount equal to the positive difference, if any, between (a) the amount to be refunded to EAGLE pursuant to Section 3.1.2 and (b) the difference between (i) [*], less (b) the total payments related to such PRODUCT and received by EAGLE from any such THIRD PARTY.
3.1.5 In the event EAGLE licenses PRODUCT to a THIRD PARTY, any milestone payments received by EAGLE with respect to commercialization of the PRODUCT in the US market [*]; however, subject to Section 3.1.4, any milestone payment received with respect to commercialization of the PRODUCT ex-US will be [*] to XXXXXX.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
ACTIVITIES, and make available for commercialization activities by EAGLE five (5) PRODUCTS as set forth in Exhibit A. Such PRODUCTS will be determined and mutually agreed upon by the DEVELOPMENT COMMITTEE from time-to-time and added to Exhibit A during the TERM. If EAGLE does not select a PRODUCT, then XXXXXX is free to move ahead on its own or a THIRD PARTY.
4. PRODUCT Development; Commercialization
4.1.1 The DEVELOPMENT COMMITTEE shall generally oversee and facilitate the development of the PRODUCTs. Each party shall promptly provide the other and the DEVELOPMENT COMMITTEE with a copy of any FDA correspondence within 48 hours of receipt thereof and it will be the responsibility of EAGLE, with the oversight and approval of the DEVELOPMENT COMMITTEE, to create an appropriate response thereto.
4.1.2 During the Term, the DEVELOPMENT COMMITTEE shall meet at least once each calendar quarter or at such other frequency as the DEVELOPMENT COMMITTEE determines. The PARTIES shall meet on a date and time and at a location determined by the DEVELOPMENT COMMITTEE; the PARTIES anticipate alternating meetings between the Party’s respective sites. Upon written notice by either Party to the other that a meeting is required or requested, a meeting will be held within thirty (30) calendar days of such notice on a date and time and at a location to be agreed upon by the PARTIES, or sooner if warranted by the circumstances. Notices requesting such a meeting shall include adequate information describing the activity to be reviewed. Any meetings of the DEVELOPMENT COMMITTEE may be held in person at a location to be agreed to by the PARTIES, or by videoconference to teleconference.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
4.1.3 In the event of the PRODUCT FAILURE, the DEVELOPMENT COMMITTEE shall select a REPLACEMENT PRODUCT within one hundred eighty (180) days of such failure. In the event the DEVELOPMENT COMMITTEE fails to select the REPLACEMENT PRODUCT within such period, EAGLE shall be entitled to a refund in accordance with Section 3.1.2.
4.1.4 The DEVELOPMENT COMMITTEE shall have no power or authority to amend this Agreement or to otherwise change any of the responsibilities or obligations of a Party under this Agreement, except as expressly agreed to in writing by such Party. Each member of the Development and Commercialization Committee will be entitled to one (1) vote and all decisions of the Development and Commercialization Committee shall be by a unanimous vote in favor of such decision. In the event that a majority of the members cannot agree, then the chief executive officer or president of each PARTY shall jointly agree.
4.3 Commercialization. The PARTIES hereby acknowledge that, during the Term, Eagle shall be the sole and exclusive distributor for the PRODUCTS in the Territory, either directly or through its AFFILIATES and/or SUBLICENSEES. All activities related to the sales and marketing of the PRODUCTs in the Territory, including the launch date of the PRODUCT, will be the sole responsibility of Eagle. Eagle shall arrange for the manufacture, testing, packaging, labeling, transportation and storage of Eagle’s requirements of commercial supplies of the PRODUCTS hereunder from a third-party contract
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
manufacturer (such third-party contract manufacturer being referred to hereafter as the “Third-Party Supplier”). Eagle may grant a right to a Third-Party Supplier to make, test, package, label, store and transport the PRODUCTS for sale by Eagle in the Territory hereunder.
4.4 Patent Marking and PRODUCT Marking.
(a) EAGLE shall place appropriate patent and/or patent pending markings on the PRODUCT or the packaging therefor. The content, form, size, location and language of such markings shall be in accordance with the LAWS and practices of the country in which the applicable units of the PRODUCT are distributed.
(b) EAGLE shall be responsible for all packaging (non-commercial and commercial) and labeling of the PRODUCT.
5. Records; Audits; Payment Terms
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Any combination of features or disclosures shall not be deemed to fall within the foregoing exclusions merely because individual features are published or known to the general public or in the rightful possession of the RECIPIENT unless the combination itself and principle of operation thereof are published or known to the general public or are in the rightful possession of the RECIPIENT.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
7.5 Ownership of ANDA or 505(b)(2) Filing. The ANDA or 505(b)(2) filing (or other MARKETING AUTHORIZATION) contemplated herein shall be owned by and in the name of EAGLE, including all information and data contained therein or used to support such filing.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
8. Representations Warranties; Covenants; Limitation of Liability
8.2.1 EAGLE covenants to XXXXXX that, conditioned upon ROBERT’s fulfillment of its obligations under this Agreement, upon and after the EFFECTIVE DATE, EAGLE shall use commercially reasonable efforts to (i) develop the PRODUCTS and file for MARKETING AUTHORIZATION for the PRODUCTS in the TERRITORY as quickly as practicable after the successful completion of all stability testing and data required for such MARKETING AUTHORIZATION, including completion of all stability procedures, (ii) obtain approval of the MARKETING AUTHORIZATION for the PRODUCTS in the TERRITORY, and (iii) upon receipt of MARKETING AUTHORIZATION of the PRODUCT, use reasonable commercial efforts to commercialize and market the PRODUCT; provided, however, that Eagle shall have no obligation to hire a hospital sales force for the marketing and selling of the PRODUCT.
8.2.2 The PARTIES acknowledge and agree that the DEVELOPMENT COMMITTEE shall, prior to MARKETING AUTHORIZATION for the PRODUCTS (or any REPLACEMENT PRODUCT), formulate an expected business plan (which shall include a detailed budget). If at any time EAGLE’s GROSS PROFIT MARGIN for such PRODUCTS for two consecutive fiscal quarters is less than, or reasonably expected to be less than the gross margin set forth in such business plan by an amount equal
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
to or greater than [*], then EAGLE shall have no obligation to continue to commercialize or market such PRODUCT.
8.2.3 If the marketing of a PRODUCT is discontinued pursuant to Section 8.2.2, the PARTIES shall use their commercially reasonable efforts to sell such PRODUCT to a THIRD PARTY. If the PARTIES are unable to sell such PRODUCT to a THIRD PARTY within [*] in the United States or [*] in countries ex-United States, then XXXXXX shall also have the right to require EAGLE, at ROBERT’S sole election and cost, to use reasonable efforts to provide XXXXXX, to the extent permitted by applicable LAW, with access to and use of the ANDA or 505(b)(2) filing (or other MARKETING AUTHORIZATION) and shall grant to XXXXXX, WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, a perpetual, irrevocable, royalty-free, non-exclusive license, with the right to sublicense, to such PRODUCT, the XXXXXX LICENSED TECHNOLOGY, the ASSIGNED PATENTS, EAGLE PATENT RIGHTS and EAGLE KNOW-HOW solely to the extent necessary to manufacture, or have manufactured solely for sale in the TERRITORY and to develop, register, and sell such PRODUCT solely in the TERRITORY. In the event that any such license is granted, XXXXXX shall pay royalties to EAGLE on the sale of such PRODUCT in the TERRITORY, according to the provisions of Articles 3 and 4, applied mutatis mutandi. As between the PARTIES, EAGLE shall be responsible for all development activities, and for the preparation, filing and maintenance of applications for MARKETING AUTHORIZATION for the finished PRODUCT in the TERRITORY.
8.2.4 In the event that EAGLE materially fails to perform its obligations under Section 8.2.1 in respect of a PRODUCT and fails to cure such default within [*] after ROBERT’s written notice thereof detailing such default (a “DEFAULT”), XXXXXX shall have the right to require EAGLE, at ROBERT’S sole election and cost, on a PRODUCT-by-PRODUCT basis, to use reasonable efforts to provide XXXXXX, to the extent permitted by applicable LAW, with access to and use of the ANDA or 505(b)(2) filing (or other MARKETING AUTHORIZATIONS) in which such DEFAULT occurred, and shall grant to XXXXXX, WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, a perpetual, irrevocable, royalty-free, non-exclusive license, with the right to sublicense, to the PRODUCT, the ASSIGNED PATENTS, the XXXXXX LICENSED TECHNOLOGY, the EAGLE PATENT RIGHTS and the EAGLE KNOW-HOW solely to the extent necessary to manufacture, or have manufactured solely for sale in such country and to develop, register, and sell the PRODUCTS the TERRITORY. In the event that any such license is granted, XXXXXX shall pay royalties to EAGLE on the sale of
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
such PRODUCT in the TERRITORY, according to the provisions of Articles 3 and 4, applied mutatis mutandi.
8.5 Limitation of Liability and Exclusion of Damages.
8.5.1 EXCEPT IN THE CASE OF (A) A BREACH OF ARTICLE 5, (B) THIRD PARTY CLAIMS AND (C) CLAIMS REGARDING INFRINGEMENT (THE LIMITATIONS OF WHICH ARE GOVERNED BY SECTIONS 8.5.2 AND 8.5.3 BELOW, WITHOUT LIMITING THE PARTIES’ OBLIGATIONS UNDER ARTICLE 8, IN NO EVENT SHALL ROBERT’S LIABILITY TO EAGLE ARISING OUT OF THIS AGREEMENT EXCEED [*] OF THE ROYALTIES PAID TO XXXXXX BY EAGLE IN ANY CALENDAR YEAR.
8.5.2 WITH RESPECT TO INFRINGEMENT CLAIMS OTHER THAN “AT RISK” (AS DEFINED IN SECTION 8.5.3 BELOW), THE LIMITATION PROVIDED IN SECTION 8.5.1 SHALL NOT APPLY; PROVIDED, HOWEVER, THAT (A)
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
IN NO EVENT IN ANY CALENDAR YEAR SHALL XXXXXX BE OBLIGATED TO MAKE PAYMENTS IN SATISFACTION OF ITS OBLIGATIONS PROVIDED IN SECTION 11.1.3 THAT EXCEED [*] OF THE ROYALTIES PAID TO XXXXXX BY EAGLE IN SUCH CALENDAR YEAR AND (B) IN NO EVENT SHALL ROBERT’S LIABILITY IN RESPECT OF SUCH CLAIMS EXCEED A MAXIMUM AMOUNT EQUAL TO THE TOTAL AMOUNT RECEIVED BY XXXXXX UNDER THIS AGREEMENT INCLUDING, FOR THE AVOIDANCE OF DOUBT, ALL MILESTONE PAYMENTS AND ROYALTY PAYMENTS.
8.5.3 In the event the parties’ elect to launch a PRODUCT “at-risk” (i.e., to commence selling a PRODUCT where prior to the first commercial sale of such PRODUCT there is a claim that the PRODUCT infringes upon third party patent rights and the patent litigation regarding such claim has not been concluded), XXXXXX agrees that [*] of all royalties paid by EAGLE with respect to such PRODUCT shall be placed in escrow pending resolution of the claim of infringement. In the event it is determined that such PRODUCT does infringe upon a THIRD PARTY patent, the amounts held in escrow shall be applied towards payment required as a result of such determination and, as required, XXXXXX shall be liable for up to [*] of all royalties paid by EAGLE with respect to such PRODUCT. In the event it is determined that such PRODUCT does not infringe upon a THIRD PARTY patent, such escrowed funds shall be released to XXXXXX.
8.5.4 EXCEPT IN THE CASE OF (A) A BREACH OF ARTICLE 5, (B) THIRD PARTY CLAIMS AND (C) CLAIMS REGARDING INFRINGEMENT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION, DAMAGES RESULTING FROM LOSS OF USE, LOSS OF PROFITS, INTERRUPTION OR LOSS OF BUSINESS OR OTHER ECONOMIC LOSS) ARISING OUT OF THIS AGREEMENT OR WITH RESPECT TO A PARTY’S PERFORMANCE OR NON-PERFORMANCE HEREUNDER EVEN IF ADVISED OF THE POSSIBILITY THEREOF.
The limitation on liability and exclusion of damages under this Section 8.5: (i) apply even if a PARTY had or should have had knowledge, actual or constructive, of the possibility of such damages; (ii) are a fundamental element of the basis of the bargain between the PARTIES and this AGREEMENT would not be entered into without such limitations and exclusions and (iii) shall apply whether a claim is based on breach of contract, breach of warranty, tort (including negligence), product liability, strict liability or otherwise, and notwithstanding any failure of essential purpose of any limited remedy herein. Moreover, the remedies under this AGREEMENT are intended to be exclusive, and the limitation on liability and exclusion of damages under this Section 8.5 are intended to apply even if
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
there is a total and fundamental breach of this AGREEMENT, and the essential purpose of these provisions is to limit the PARTIES’ respective liabilities hereunder.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
of [*] per occurrence and in the aggregate and shall maintain product liability insurance in the minimum amount of [*] per occurrence and [*] in the aggregate. Such policies shall include a provision that XXXXXX shall be given [*] written notice prior to cancellation or material change, including non-payment, in such a policy. The insurance carriers must be rated A-, VII or better by A.M. Best Company. EAGLE shall maintain such insurance for the TERM, and shall from time to time provide copies of certificates of such insurance to XXXXXX upon its request. If the insurance policy is written on a claims-made basis then the coverage must be kept in place for at least three (3) years after the termination of this AGREEMENT.
XXXXXX, at its own expense, shall maintain comprehensive general liability insurance, in the initial minimum amount of [*] per occurrence and [*] in the aggregate, along with general umbrella insurance in the additional amount of at least [*], and thereafter in such amounts as the shall be reasonably determined by the parties. Such policies shall include a provision that EAGLE shall be given [*] written notice prior to cancellation or material change, including non-payment, in such a policy. The insurance carriers must be rated A-, VII or better by A.M. Best Company. XXXXXX shall maintain such insurance for the TERM, and shall from time to time provide copies of certificates of such insurance to EAGLE upon its request. If the insurance policy is written on a claims-made basis then the coverage must be kept in place for at least three (3) years after the termination of this AGREEMENT.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
the indemnified PARTY, in its sole discretion, may take control of the action at the indemnifying PARTY’S expense.
10. INVENTIONS, KNOW-HOW and PATENTS
10.1 Existing Intellectual Property. Other than as expressly provided in this AGREEMENT, neither PARTY grants nor shall be deemed to grant any right, title or interest to the other PARTY in any PATENT, PATENT APPLICATION, KNOW-HOW or other intellectual property right owned or CONTROLLED by such PARTY.
10.2 Disclosure. Each PARTY shall promptly disclose to the other in writing all INVENTIONS arising from separate activities relating to improvements to the PRODUCTS and all INVENTIONS arising from joint activities (including any INVENTIONS first made, conceived or first reduced to practice as a result of such activities), or those of its agents or independent contractors, in connection with the performance of its obligations or activities under this AGREEMENT.
10.3 Ownership of INVENTIONS. Except for INVENTIONS that fall within the definition of ASSIGNED PATENTS and are therefore owned by EAGLE pursuant to Section 2.1, (a) all INVENTIONS made solely by employees, agents or independent contractors of a PARTY during the performance of this AGREEMENT (each, a “SOLE INVENTION”) shall be the exclusive property of such PARTY, and (b) if employees, agents or independent contractors of each of XXXXXX and EAGLE jointly develop any INVENTION during the performance of activities conducted in connection with this AGREEMENT (each, a “JOINT INVENTION”), EAGLE and XXXXXX shall each own an undivided one-half (1/2) interest in and to such JOINT INVENTION, and shall have the right to freely exploit and grant licenses under any such JOINT INVENTION and any PATENT claiming such JOINT INVENTION without consent of or a duty of accounting to the other PARTY. For the avoidance of doubt, the determination as to whether an INVENTION has been “solely” or “jointly” made shall be based upon whether employees, agents or independent contractors of a PARTY would be or are properly named as an inventor on a corresponding PATENT APPLICATION under United States inventorship LAWS.
10.4 Individual PATENT Filings. Each PARTY shall have sole discretion and right to prepare, file, prosecute, maintain and defend PATENT APPLICATIONS or PATENTS for INVENTIONS it solely owns under this AGREEMENT, and shall be responsible for related interference proceedings. Each PARTY shall confer with the other PARTY and shall give due consideration to the other PARTY’S suggestions regarding the prosecution of such PATENT APPLICATIONS, and shall copy the other PARTY on any official actions and submissions in such PATENT APPLICATIONS. Costs incurred with respect to PATENT
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
APPLICATIONS shall be borne by the PARTY with the right to prosecute each such PATENT APPLICATION. For the avoidance of doubt, EAGLE shall have the sole discretion and right to prosecute, maintain and defend the PATENT APPLICATIONS included in the ASSIGNED TECHNOLOGY.
10.5 Joint PATENT Filings. With respect to all PATENT APPLICATIONS on JOINT INVENTIONS that are jointly owned by the PARTIES (the “JOINT PATENT APPLICATIONS”), the PARTIES shall determine which PARTY shall be responsible for filing, prosecuting and maintaining PATENT APPLICATIONS and PATENTS on behalf of both PARTIES (the “RESPONSIBLE PARTY”) based on a good faith determination of the relative contributions of the PARTIES to the INVENTION and the relative interests of the PARTIES in the INVENTION. At least twenty (20) days prior to the contemplated filing of such PATENT APPLICATION, the RESPONSIBLE PARTY shall submit a substantially completed draft of the JOINT PATENT APPLICATION to the other PARTY for its approval, which shall not be unreasonably withheld or delayed. Except as set forth below, the PARTIES shall share equally the costs of the preparation, filing, prosecution and maintenance of all JOINT PATENT APPLICATIONS. If either PARTY elects not to pay its portion of any shared costs for a JOINT PATENT APPLICATION or PATENT issuing therefrom, the other PARTY may proceed with such JOINT PATENT APPLICATION in its own name and at its sole expense, in which case the PARTY electing not to pay its share of costs hereby agrees to transfer and assign and shall transfer and assign its entire right, title and interest in and to such JOINT PATENT APPLICATION to the other PARTY and such INVENTION shall be treated as a SOLE INVENTION of the assignee for the purposes of Sections 10.3 and 10.4 and this Section 10.5.
10.6 Assignment. Notwithstanding anything in this Article 10 to the contrary, nothing herein shall modify or interfere with the assignment to EAGLE of the ASSIGNED PATENTS pursuant to Section 2.1.
10.7 Further Actions. Each PARTY shall cooperate with the other PARTY to execute all documents and take all reasonable actions to effect the intent of this Article 9.
11.1 Infringement of THIRD PARTY Rights.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
11.2 Infringement By THIRD PARTIES
11.2.2 Prosecution of Actions Relating to XXXXXX LICENSED TECHNOLOGY.
(a) XXXXXX shall have the primary right, but not the obligation, to institute, prosecute and control any action or proceeding with respect to any infringement by a THIRD PARTY of XXXXXX LICENSED TECHNOLOGY using counsel of its own choice, at its own expense. EAGLE shall cooperate with XXXXXX at ROBERT’S request and expense in the prosecution of such action or proceeding. If XXXXXX determines that EAGLE is an
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
indispensable PARTY to the action, EAGLE hereby consents to be joined, and XXXXXX shall defend, indemnify and hold each EAGLE INDEMNITEE harmless from any counterclaims filed against such EAGLE INDEMNITEE (except for CLAIMS for which EAGLE has an obligation to defend, indemnify and defend XXXXXX under Section 9.1.2). EAGLE shall have the right to be represented in that action by its own counsel and at its own expense.
(b) If XXXXXX fails to bring an action or proceeding within a period of thirty (30) days after receiving written notice from EAGLE of such infringement or misappropriation by a THIRD PARTY, EAGLE shall have the right to bring and control any such action using counsel of its own choice, and at its own expense. If EAGLE determines that XXXXXX is an indispensable PARTY to the action, XXXXXX hereby consents to be joined. In such event, XXXXXX shall have the right to be represented in such action by its own counsel at its own expense. No settlement, consent judgment or other voluntary final disposition of a suit under this Section 11.2.2 may be entered into without the joint consent of EAGLE and XXXXXX (which consent shall not be unreasonably withheld or delayed). EAGLE shall be entitled to deduct its costs of litigation from royalty payments due under Section 3.2.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
11.2.3 Prosecution of Actions Related to the PRODUCTs.
(a) Except as otherwise provided in Section 11.2.2, EAGLE shall have the primary right, but not the obligation, to institute, prosecute and control any action or proceeding with respect to infringement or misappropriation by a THIRD PARTY in the TERRITORY of any PATENT, PATENT APPLICATION or KNOW-HOW owned or CONTROLLED by EAGLE related to the PRODUCT, using counsel of its own choice, at its own expense. XXXXXX shall cooperate with EAGLE at EAGLE’s request and expense in the prosecution of such action or proceeding. If EAGLE determines that XXXXXX is an indispensable PARTY to the action, XXXXXX hereby consents to be joined, and EAGLE shall defend, indemnify and hold each XXXXXX INDEMNITEE harmless from any counterclaims filed against such XXXXXX INDEMNITEE (except for CLAIMS for which XXXXXX has an obligation to defend, indemnify and defend EAGLE under Section 9.1.1). In such event, XXXXXX shall have the right to be represented in that action by its own counsel and at its own expense. EAGLE shall be entitled to deduct its costs of litigation from royalty payments of any PRODUCT due under Section 3.2.
(b) If EAGLE fails to bring an action or proceeding within a period of thirty (30) days after receiving written notice from XXXXXX of such infringement or misappropriation by a THIRD PARTY related to the PRODUCT, XXXXXX shall have the right to bring and control any such action using counsel of its own choice, and at its own expense. If XXXXXX determines that EAGLE is an indispensable PARTY to the action, EAGLE hereby consents to be joined, and XXXXXX shall defend, indemnify and hold each EAGLE INDEMNITEE harmless from any counterclaims filed against such EAGLE INDEMNITEE. In such event, EAGLE shall have the right to be represented in such action by its own counsel at its own expense. No settlement, consent judgment or other voluntary final disposition of a suit under this Section 11.2.3 may be entered into without the joint consent of both EAGLE and XXXXXX (which consent shall not be unreasonably withheld or delayed).
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
12. Further Responsibilities of XXXXXX
12.1 XXXXXX shall promptly provide EAGLE with all validated analytical methods for the testing of the PRODUCTS active pharmaceutical ingredient required for filing and maintenance of MARKETING AUTHORIZATIONS for the PRODUCTS in the TERRITORY.
12.2 XXXXXX shall promptly provide EAGLE with all stability data generated on research formulations and pilot batches of the PRODUCT. Furthermore, XXXXXX shall successfully complete all research stability studies and promptly provide EAGLE with all data therefrom.
12.3 XXXXXX shall provide EAGLE with technical support as reasonably requested by EAGLE relating to the scale-up of the manufacturing process for the PRODUCTS and the manufacturing of the FDA filing lots of the PRODUCTS at EAGLE’s contract manufacturer, EAGLE AFFILIATE or EAGLE marketing partner. In addition, XXXXXX will assist EAGLE in responding to FDA, and other related regulatory bodies, with respect to questions on the ANDA or 505(b)(2) filing that relate to the manufacturing process of the PRODUCTS or related analytical methods.
12.4 XXXXXX shall promptly provide EAGLE with all information, back-up information, data and correspondence utilized in the filing of the ASSIGNED PATENTS. Furthermore, XXXXXX shall assist EAGLE with the compilation of information for and filing of further PATENT APPLICATIONS relating to the PRODUCTS in the TERRITORY. All such PATENT APPLICATIONS shall be owned by EAGLE.
12.5 XXXXXX shall assist EAGLE in gathering toxicology information from the literature or any other scientific information required to support the ANDA or 505(b)(2) filings for the PRODUCT.
12.6 All reasonable, out-of-pocket costs and expenses pre-approved by EAGLE, including travel expenses, incurred by XXXXXX in the performance of its activities under this Article 12 shall be borne by EAGLE.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
failure to comply is not corrected by the failing PARTY within [*] after written notice of any failure to make timely payment of royalties or any other amount, when due hereunder, or within [*] after receipt of written notice of any other failure from the non-failing PARTY.
13.3 Additional Termination Rights. The PARTIES hereto shall have the additional termination rights:
13.3.1 If the costs and expenses of the clinical trials for either PRODUCT are reasonably expected to be greater than [*], then EAGLE may terminate this Agreement with respect to such PRODUCT.;
13.3.2 If (i) the ANDA or 505(b)(2) applications for the formulation of the PRODUCT has not been accepted by the FDA; or (ii) the ANDA or 505(b)(2) has not been approved by the FDA.
13.4.1 Except as other wise provided in Section 13.4.3 below, the provisions of Sections 2.1 (further assurances), 2.2 (license), 2.3, 2.4, 2.6 (further assurances), 3.3, 7.4, 8.5, 12.7, 13.4, 16.2, 16.4, 16.7, 16.9 and 16.10 and Articles 5, 6, 9, 10, 11, 14 and 15 (and in each case together with any defined terms applicable to such provisions) shall survive termination of this AGREEMENT for any reason whatsoever.
13.4.2 If this AGREEMENT is terminated by EAGLE pursuant to Section 13.2, then EAGLE shall have an exclusive, royalty-free, fully-paid up, perpetual license to the LICENSED TECHNOLOGY to make, sell and have sold the PRODUCTS in the TERRITORY.
13.4.3 If this AGREEMENT is terminated by XXXXXX pursuant to Section 13.2 or 13.3, then EAGLE shall (A) transfer and assign to XXXXXX all rights to (i) the ASSIGNED PATENTS and (ii) the MARKETING AUTHORIZATIONS to the PRODUCTS and (B) automatically be deemed to have granted to XXXXXX, WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, a perpetual, irrevocable, royalty-free, exclusive license, with the right to sublicense, to the PRODUCT, the XXXXXX LICENSED TECHNOLOGY, the ASSIGNED PATENTS, the EAGLE PATENT RIGHTS and the EAGLE KNOW-HOW solely to the extent necessary to manufacture, or have manufactured anywhere in the world solely for sale in the TERRITORY and develop, register, and sell and have sold the PRODUCTS in the TERRITORY. If the event EAGLE fails to execute any document or instrument necessary to effectuate the foregoing, EAGLE hereby grants an irrevocable power of attorney to XXXXXX solely for such purposes. In the event of a termination of this AGREEMENT pursuant to Section 13.2, Sections 3.3, 5.1-5.3 (but only with respect to PRODUCTS sold by EAGLE), 7.4, 8.5, 12.7, 13.4, 16.2, 16.4, 16.7, 16.9 and 16.10 and
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Articles 6, 9, 10, 14 and 15 (and in each case together with any defined terms applicable to such provisions) shall survive termination of this AGREEMENT.\
13.4.4 If this Agreement is terminated by EAGLE pursuant to Sections 13.3.1 or 13.3.2, then the license granted by XXXXXX in respect of the PRODUCT(S) shall terminate immediately and EAGLE shall be entitled to the repayment of the paid milestone in respect of the PRODUCT(S) as if there had been a PRODUCT FAILURE.
13.4.5 This Agreement shall automatically terminate upon the initiation of any proceeding in bankruptcy, reorganization, dissolution, liquidation or arrangement for the appointment of a receiver or trustee to take possession of the assets of a party hereto or similar proceeding under the law for release of creditors by or against a party hereto or if a party hereto shall make a general assignment for the benefit of its creditors. All licenses and rights to licenses granted under or pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code (the “Code”), licenses of rights to “intellectual property” as defined under Section 101(35A) of the Code. Either party, as a licensee of such rights under this Agreement (the “non-Bankrupt Party”), shall retain and may fully exercise all of its rights and elections under the Code, and upon commencement of a bankruptcy proceeding by or against the other party (the “Bankrupt Party”) under the Code, shall be entitled to a complete duplicate of, or complete access to (as the non-Bankrupt Party deems appropriate), any such intellectual property and all embodiments of such intellectual property. Such intellectual property and all embodiments thereof shall be promptly delivered to the non-Bankrupt Party (a) upon any such commencement of a bankruptcy proceeding upon written request therefor by the non-Bankrupt Party, unless the Bankrupt Party elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under (a) above, upon the rejection of this Agreement by or on behalf of the Bankrupt Party upon written request therefor by the non-Bankrupt Party, and each party hereby acknowledges and agrees that the foregoing shall serve as its consent to such transfer of the intellectual property and all embodiments thereof. The foregoing provisions of this Section 13.4.6 are without prejudice to any rights the non-Bankrupt Party may have arising under the Code or other applicable law.
13.4.6 Notwithstanding anything in this AGREEMENT to the contrary, if this AGREEMENT is terminated for any reason whatsoever, EAGLE shall pay XXXXXX all accrued milestone payments and accrued royalties in accordance with the terms of this AGREEMENT.
13.4.7 Termination of this AGREEMENT by a PARTY shall not be an exclusive remedy and all other remedies will be available to the terminating PARTY, in equity and at LAW.
13.4.8 If this Agreement is terminated in respect of any PRODUCT, then this Agreement shall continue in full force and effect in respect of any other the PRODUCT.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
13.4.9 The termination or expiration of this Agreement shall not affect any payment or other obligations or liabilities that have accrued prior to or on the date of such termination or expiration, and the PARTIES shall retain all rights and remedies (at law or in equity) in respect of any breach hereof.
13.4.10 In the event of termination by either PARTY pursuant to Section 13.1, 13.2, EAGLE shall have the right, but not the obligation, to sell off any inventory on hand or in transit to EAGLE. For any PRODUCT sales, EAGLE will appropriately pay XXXXXX its ROYALTY RATE.
13.4.11 In the event XXXXXX terminates the Agreement pursuant to Section 13.1, 13.2, EAGLE shall have the right to cancel any purchase orders placed, which have not yet shipped.
Unless otherwise expressly permitted hereunder, neither PARTY may assign any of its rights or delegate any of its duties under this AGREEMENT without the prior written consent of the other PARTY, except that either PARTY may assign its rights and responsibilities hereunder without the other PARTY’S consent as part of: (i) either (a) the sale of all or substantially all of the assets or the entire business to which this AGREEMENT relates or (b) a merger, consolidation, reorganization or other combination with or into another person or entity; or (ii) the transfer or assignment to an AFFILIATE, in each case, pursuant to which the surviving entity or assignee assumes the assigning or merging PARTY’S obligations hereunder in writing. Subject to confidentiality obligations, each PARTY shall use reasonable efforts to notify the other PARTY at least thirty (30) days in advance of any such assignment. Any assignment made in violation of this Article 14 shall be null and void. Notwithstanding the foregoing, EAGLE acknowledges that XXXXXX intends to use TherDose Private Parma Limited, an Indian Private Limited company, solely to perform analytical testing for the PRODUCT, and XXXXXX agrees that it shall remain responsible to EAGLE for all acts and omissions of Thermoses.
Any notice or other communication or payment herein required or permitted to be given shall be deemed sufficient if and when personally delivered in writing or if and when given by United States registered or certified mail, postage prepaid, return receipt requested, properly addressed to the respective addresses of the PARTIES as written below. Notices so given shall be effective upon the earlier to occur of (i) receipt by the PARTY to which notice is given, or (ii) the fourth (4th) business day following the date such notice was posted, whichever occurs first.
If to EAGLE, addressed to:
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Eagle Pharmaceutical, Inc.
470 Xxxxxxxx Xxxxx
Xxxxxxxxx Xxxx, XX 00000
Attn: Xxxxx Tariff, Chief Executive Officer
Fax: With copies (which shall not constitute notice), to:
Xxxxxx, Xxxxxxxxxx & Xxxxxxxxx LLP
660 Xxxxx Xxxxxx
Xxx Xxxx, XX 00000
Attn: X. Xxxx Milling, Jr., Esq.
Fax: (000) 000-0000
If to XXXXXX, addressed to:
120 Xxxxxxxxxx Xxxx
Xxxxxxx, XX 00000
Attention: Xxxxxx X. Xxxxx
President & CEO
With copies (which shall not constitute notice), to:
Xxxxx Xxxxxx Xxxxxxxx & Xxxxxx LLP
420 Xxxxxxxxx Xxxxxx, Xxxxx 0000
Xxx Xxxx, Xxx Xxxx 00000
Attention: Xxxxxxxx Xxxxxx
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
shall to that extent be deemed not to form part of this AGREEMENT, and the enforceability, legality and validity of the remainder of this AGREEMENT shall not be affected thereby.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
16.9 Governing LAW. This AGREEMENT shall be governed by and construed in accordance with the LAWS of the State of Delaware without regard to its or any other jurisdiction’s choice of LAW rules. Any disputes under this AGREEMENT shall be brought in the state or federal courts located in New York. The PARTIES submit to the personal jurisdiction of such courts for any such action, agree that such courts provide a convenient forum for any such action, and waive any objections or challenges to venue with respect to such courts.
[Signature Page Follows]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Signed:
For and on behalf of: |
For and on behalf of: | |||||
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XXXXXX ONE, LLC |
EAGLE PHARMACEUTICAL, INC. | |||||
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Signature: |
/s/ Xxxxxx X. Xxxxx |
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Signature: |
/s/ Xxxxx Xxxxxxx | ||
Name: |
Xxxxxx X. Xxxxx |
Name: |
Xxxxx Xxxxxxx | |||
Title: |
President & CEO |
Title: |
Chief Executive Officer | |||
Dated: |
January 27, 2008 |
Dated: |
January 27, 2008 | |||
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
EXHIBIT A: PRODUCTS
Five products to be agreed upon by the DEVELOPMENT COMMITTEE and added from time-to-time to Exhibit A.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
SCHEDULE I
PATENT APPLICATIONS
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
SCHEDULE II
Milestones
Pursuant to Section 3.1, the following payments shall be payable by EAGLE to XXXXXX upon occurrence of the following milestone events with respect to each of the PRODUCT:
Milestone Event |
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Milestone Payment (US DOLLARS) |
[*] |
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[*] |
[*] |
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[*] |
[*] |
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[*] |
[*] |
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[*] |
[*] |
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[*] |
[*] |
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[*] |
The milestone payment schedule may be amended from time to time with mutual consent of PARTIES.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
SCHEDULE III
Allocation of Milestones
PRODUCT |
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Effective Date |
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FDA filing acceptance of 505(b)(2) or ANDA (as applicable) |
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Commercial launch |
PRODUCT #1 |
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[*] |
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[*] |
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[*] |
PRODUCT #2 |
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[*] |
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[*] |
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[*] |
PRODUCT #3 |
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[*] |
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[*] |
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[*] |
PRODUCT #4 |
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[*] |
|
[*] |
|
[*] |
PRODUCT #5 |
|
[*] |
|
[*] |
|
[*] |
TOTAL |
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[*] |
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[*] |
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[*] |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Reference is made to that certain Development and Licensing Agreement dated as of March 18, 2008, as amended (the “Agreement”), by and between Eagle Pharmaceuticals, Inc., and Xxxxxx One LLC (formerly identified as Xxxxxx LLC). Capitalized terms used herein and not otherwise defined shall have the meanings ascribed to such terms in the Agreement.
Pursuant to Section 3.4 of the Agreement, the five PRODUCTS designated for Exhibit A of the Agreement are:
Product #1. [*]
Product #2. [*]
Product #3. [*]
Product #4. Bendamustine parenteral formulation
Product #5. [*]
ACCEPTED AND AGREED TO AS OF NOVEMBER 11, 2009:
EAGLE PHARMACEUTICALS, INC. |
XXXXXX ONE LLC | |||
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By: |
/s/ Xxxxx Xxxxxxx |
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By: |
/s/ Xxxxxx X. Xxxxx |
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Xxxxx Xxxxxxx, President and CEO |
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Xxxxxx X. Xxxxx, President and CEO | |
EXECUTION VERSION
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
THIS AGREEMENT (this “Agreement”) is made as of July 16, 2013 by and between Eagle Pharmaceuticals, Inc. (“EAGLE”), SciDose LLC(“SCIDOSE”), Xxxxxx One (“XXXXXX”) and Therdose, LLC (“THERDOSE”; and, collectively with SCIDOSE AND XXXXXX, the “SCIDOSE PARTIES”).
1. Amendments to the 2008 Eagle/Xxxxxx Agreement.
(a) Amendment to Section 1. Section 1 of that certain Development and License Agreement dated as of March 18, 2008, as amended (the “2008 Eagle/Xxxxxx Agreement”), by and between the EAGLE and XXXXXX is hereby amended by adding the following new definition as a new Section 1.41:
“1.41 “BENDAMUSTINE PRODUCTS” means, together, the Bendamustine parenteral formulation product (i.e., the RTU Bendamustine product licensed hereunder) and EAGLE [*] Bendamustine product.”.
(b) Amendment to Section 1.32. The first sentence of Section1.32 of the 2008 Eagle/Xxxxxx Agreement is hereby amended by deleting such sentence only and replacing it with:
“1.32 “PRODUCT(S)” means five (5) ANDA or 505(b)(2) products as set forth in Exhibit A, and will expressly include the BENDAMUSTINE PRODUCTS.”
(c) Amendment to Section 1.37. Section 1.37 of the 2008 Eagle/Xxxxxx Agreement is hereby amended by deleting such Section in its entirety and replacing it with the following:
“1.37 “ROYALTY RATE” means (i) with respect to any PRODUCT that is subject to a 505(b)(2) application, [*] and (ii) with respect to any PRODUCT that is subject to an ANDA application, [*]; provided, however, that, with respect to the BENDAMUSTINE PRODUCTS, the ROYALTY RATE means [*].”
(d) Amendment to Section 3.2. Section 3.2 of the 2008 Eagle/Xxxxxx Agreement is hereby amended by deleting such Section its entirety and replacing it with the following:
“For the applicable ROYALTY TERM for each PRODUCT, EAGLE shall pay XXXXXX royalties on sales of PRODUCTS by EAGLE and its AFFlLIATES in the TERRITORY in an amount equal to the ROYALTY RATE multiplied by the GROSS PROFIT from the number of units of PRODUCTS sold; provided, however, that, (i) at any time during [*] after the FIRST COMMERCIAL SALE of a PRODUCT, there is no VALID PATENT CLAIM covering the manufacture, use, import or sale of such PRODUCT in a country in the Territory, then (i) with respect to a PRODUCT (or any REPLACEMENT PRODUCT, as applicable) other than the BENDAMUSTINE PRODUCTS, the ROYALTY RATE shall be reduced to [*] in such country. Notwithstanding the foregoing, EAGLE shall no longer have an obligation to pay royalties to XXXXXX or any of’ its AFFILIATES in respect of the sales of BENDAMUSTINE PRODUCTS after EAGLE has paid royalties to XXXXXX in an amount equal to [*] from the sales of BENDAMUSTINE PRODUCTS (the “ROYALTY CAP”) and, after EAGLE shall have paid the ROYALTY CAP, the license in respect of the BENDAMUSTINE PRODUCTS shall be [*].”
(e) Amendment to Section 8.4. Section 8.4 of the 2008 Eagle/Xxxxxx Agreement is hereby amended by adding the following sentence:
‘‘Notwithstanding the foregoing, XXXXXX and any of its AFFILIATES shall be entitled to develop, manufacture and Commercialize ANDA formulations for its own account in respect of [*].”
(f) Effect on the 2008 Eagle/Xxxxxx Agreement. Except as specifically amended herein, the 2008 Eagle/Xxxxxx Agreement, al1 other documents, instruments and agreements executed and/or delivered in connection then with, shall remain in full force and effect, and are hereby ratified and confirmed.
2. Amendments to the 2009 Eagle/Xxxxxx Agreement. On December 23, 2010, the XXXXXX and EAGLE amended the February 13, 2009 License and Development Agreement (the “2009 Eagle/Xxxxxx Agreement”) to include [*] and [*] as PRODUCTS. The parties hereto
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
agree that such amendment, in respect of such products only, is hereby terminated and of no force and effect and that EAGLE shall have no rights, and XXXXXX shall have no obligations, in respect of such products under the 2009 Eagle/Xxxxxx Agreement or otherwise. For the avoidance of doubt, except as set forth in this Section 2, the 2009 Eagle/Xxxxxx Agreement, all other documents, instruments and agreements executed and/or delivered in connection therewith, shall remain in full force and effect.
3. Sharing of Expenses, Costs and Awards.
(a) The parties hereto agree that any damages award paid to or recovered by EAGLE in the arbitration styled “Eagle Pharmaceutical, Inc. v. The Medicines Company, American Arbitration Association Case# 13 122 Y 02642” (the “Arbitration”) shall be [*] by EAGLE and SCIDOSE; provided, however, that, prior to the distribution of any portion of such award to SCIDOSE, EAGLE shall deduct from such award the following:
(i) [*] paid by EAGLE to Xxxxxxxxx Xxxxxxx LLP in respect of the Arbitration through June 30. 2013 (subject to later true up) including [*] as set forth on the exhibit attached hereto;
(ii) excluding fees set forth in Section 3(a)(i) above, any [*] payable by EAGLE to Xxxxxxxxx Traurig LLP in respect of the Arbitration;
(iii) subject to Section 4 below, [*]; and
(iv) [*] incurred in respect or the development and licensing of the bivalirudin and Arbitration support as set forth on Exhibit C attached hereto.
Payment of SCIDOSl’s portion of such award, if not paid directly by The Medicines Company to SCI DOSE, shall be remitted to SCIDOSE within [*] of payment by The Medicines Company.
(b) By way of example, if the award in the Arbitration equals [*], such award would be distributed as follows:
(i) To EAGLE, an amount equal to approximately [*] in reimbursement of amounts previously paid to Xxxxxxxxx Xxxxxxx as described in Section 3(a)(l) above, then
(ii) To Xxxxxxxxx Traurig, an amount equal to [*] in satisfaction of the amounts described in Section 3(a)(ii) above, then
(iii) To EAGLE, [*] to reimburse EAGLE fix costs incurred in respect of the Arbitration as described in Section 3(a)(iii) above, then
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(iv) To EAGLE [*] to EAGLE to reimburse EAGLE for out- of-pocket expenses actually incurred as described in Section 3(a)(iv) above, then
(v) To the SCIDOSE PARTIES, [*], and to EAGLE, [*].
5. Aggregate Limitation on all Payments from EAGLE to SClDOSE PARTIES and AFFILIATES. The parties hereto agree that, during the 90-day period beginning on the date hereof they will negotiate in good faith the parameters, consideration and conditions around a [*] aggregate cap of amounts owed by EAGLE to the SCIDOSE PARTIES under the DEVELOPMENT AGREEMENTS.
[The remainder of this page has been intentionally left blank.]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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EAGLE PHARMACEUTICALS, INC. | ||
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By: |
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Name: |
Xxxxx Xxxxxxx |
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Title: |
President and CEO |
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XXXXXX ONE, LLC | ||
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By: |
/s/ Xxxxxx Xxxxx | |
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Name: |
Xxxxxx Xxxxx |
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Title: |
President and CEO |
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SCIDOSE, LLC | ||
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By: |
/s/ Xxxxxx Xxxxx | |
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Name: | |
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Title: | |
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THERDOSE, LLC | ||
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By: |
/s/Xxxxxx Xxxxx | |
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Name: | |
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Title: |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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EAGLE PHARMACEUTICALS, INC. | ||
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By: |
/s/ Xxxxx Tariff | |
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Name: |
Xxxxx Xxxxxxx |
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Title: |
President and CEO |
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XXXXXX ONE, LLC | ||
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By: |
/s/ Xxxxxx Xxxxx | |
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Name: |
Xxxxxx Xxxxx |
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Title: |
President and CEO |
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SCIDOSE, LLC | ||
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By: |
/s/ Xxxxxx Xxxx | |
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Name: | |
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Title: |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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THERDOSE, LLC | |
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By: |
/s/ Xxxxxx Xxxxx |
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Name: |
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Title: |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Exhibit A
List of Agreements between EAGLE and SCIDOSE PARTIES
Agreement Date |
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Development Partner |
June 12, 2007 |
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Development and License Agreement by and between Eagle Pharmaceuticals, Inc. and SciDose, LLC |
September 24, 2007 |
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Development and License Agreement by and between Eagle Pharmaceuticals, Inc. and SciDose, LLC |
March 18, 2008 |
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Development and License Agreement between Eagle Pharmaceuticals, Inc. and Xxxxxx One, LLC |
February 13, 2009 |
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Development and License Agreement between Eagle Pharmaceuticals, Inc. and Xxxxxx One, LLC |
May 22, 2009 |
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Letter Amendment — Eagle & SciDose / Xxxxxx One |
March 18, 2008 |
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Amendment No. 1 to Development and Licensing Agreement |
March 25, 2008 |
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Amendment No. 2 to Development and Licensing Agreement |
November 20, 2009 |
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Amendment |
December 23, 2010 |
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Letter Amendment — Eagle & SciDose / Xxxxxx one |
December 3, 2008 |
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Amendment No. 3 to Development and Licensing Agreement |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Exhibit B
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$000’s |
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Commentary |
BIVALIRUDIN ARBITRATION |
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Xxxxxxxxx Legal Expenses |
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Xxxxxxxxx Fees |
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[*] |
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Xxxxxxxxx Legal — [*] |
*Xxxxxxxxx Out of Pocket |
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[*] |
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Xxxxxxxxx out of pocket — needs to be reconciled |
*Estimated Total Payments made by Eagle through 6/30/13 |
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[*] |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Exhibit C
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$000’s |
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Commentary |
Bivalirudin |
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Milestone Payment |
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[*] |
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6/12/07 Agreement |
OOP |
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[*] |
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Unreimbursed Eagle expenses (’07-’08) |
Orrick — Contracting |
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[*] |
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Legal |
FLH |
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[*] |
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Legal |
Clotting |
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[*] |
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Clotting Study |
*Estimated Total Payments made by Eagle through 6/30/13 |
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[*] |
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*All costs are subject to true up
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.