EX-10.1 2 dex101.htm SETTLEMENT AND RELEASE AGREEMENT EXECUTION COPY SETTLEMENT AND RELEASE AGREEMENT
Exhibit 10.1
EXECUTION COPY
SETTLEMENT AND RELEASE AGREEMENT
THIS SETTLEMENT AND RELEASE AGREEMENT (the “Agreement”) is made and entered into as of April 7, 2008 (the “Effective Date”) by and between Repligen Corporation, a Delaware corporation having offices at 00 Xxxxx Xxxxxx, Xxxxxxxx #0, Xxxxx 000, Xxxxxxx, XX 00000, The Regents of the University of Michigan having offices at 0000 X. Xxxxxxxxxx Xxx., 0xx Xxxxx, Xxx Xxxxx, XX 00000 and Xxxxxxx-Xxxxx Squibb Company, a Delaware corporation having offices at Xxxxx 000 & Xxxxxxxx Xxxx Xxxx, Xxxxxxxxx, XX 00000.
RECITALS
ARTICLE 1
The terms in this Agreement with initial letters capitalized, whether used in the singular or the plural, shall have the meaning set forth below or, if not listed below, the meaning designated in places throughout this Agreement.
1.1 “Affiliate” means any Person that (directly or indirectly) through one or more intermediaries, controls, is controlled by, or is under common control with the Party specified. For the purposes of this definition, “control” shall mean the possession, direct or indirect, of the power to cause the direction of the management and policies of a Person, whether through ownership of fifty percent (50%) or more of the voting securities of such Person, by contract or otherwise.
1.2 “Belatacept” means the fusion protein known as Belatacept (also known as LEA29Y), and any pharmaceutical product containing such protein.
1.3 “BMS” means Xxxxxxx-Xxxxx Squibb Company.
1.4 “BMS Released Parties” and “BMS Releasor” means BMS’s agents, servants, attorneys, employees, officers, directors, Affiliates, predecessors, successors, assigns, licensors, transferees (including but not limited to Sublicensees), representatives and all persons and entities acting by, through, under, or in concert with them or any of them (but excluding Licensor or any Licensor Releasor to the extent that such Licensor or Licensor Releasor would otherwise become a BMS Released Party or BMS Releasor by virtue of a right or license granted in or pursuant to this Agreement).
1.5 “Business Day” or “business day” means a day other than Saturday, Sunday or any day on which commercial banks located in New York, New York are authorized or obligated by applicable laws to close.
1.6 “Calendar Quarter” means each three month period commencing January 1, April 1, July 1 and October 1 of each year during the term of this Agreement.
1.7 “Calendar Year” means each successive period of 12 months commencing on January 1 and ending on December 31.
1.8 “Combination Product” means a Product that includes at least one additional active ingredient (whether coformulated or copackaged) (which is not a protein as defined in Section 1.28 below) in addition to the protein as defined in Section 1.28. Drug delivery vehicles, adjuvants, and excipients shall not be deemed to be “active ingredients”, except in the case where such delivery vehicle, adjuvant, or excipient is recognized by the FDA as an active ingredient in accordance with 21 CFR 210.3(b)(7).
1.9 “Controlled” or “Controls” means, with respect to any Patent, possession by a Licensor of the right, whether directly or indirectly, and whether by ownership, license or otherwise, to grant a license or sublicense or covenant not to xxx under such Patent to BMS as provided for herein without violating the terms of any agreement in effect as of the Effective Date with any Third Party.
1.10 “CTLA4” means cytotoxic T lymphocyte-associated antigen 4.
1.11 “Dollar” or “$” means the lawful currency of the United States.
1.12 “Effective Date” shall have the meaning set forth in the preamble of this Agreement.
1.13 “Field” means the diagnosis, treatment, control or prevention of any human disease, disorder or condition.
1.14 “GAAP” means U.S. Generally Accepted Accounting Principles.
1.15 “HHMI” means the Xxxxxx Xxxxxx Medical Institute.
1.16 “Licensed CTLA4 Product” means (i) any protein (including a fusion protein) that contains all or a portion of the extracellular domain of CTLA4, (ii) any other soluble CTLA4 molecule and (iii) CTLA4 antibodies; and any pharmaceutical product containing any of the foregoing. For clarity, “Licensed CTLA4 Product” includes without limitation Belatacept and Product.
1.17 “Licensed Patents” means the Xxxxxxxx Patent Rights and the Other Patents.
1.18 “Licensor” means each of Repligen and UM individually. “Licensors” means Repligen and UM collectively.
1.19 “Licensor Releasor” and “Licensor Released Parties” means for each Licensor, their respective agents, servants, attorneys, employees, officers, directors, Affiliates, predecessors, successors, assigns, licensors, transferees, representatives and all persons and entities acting by, through, under, or in concert with them or any of them (but excluding BMS or any BMS Releasor to the extent that BMS or such BMS Releasor would otherwise become a Licensor Released Party or Licensor Releasor by virtue of a right or license granted in or pursuant to this Agreement).
1.20 “Navy” means individually and collectively the United State Department of the Navy, the Naval Medical Research Center and/or The United States of America as represented by the Secretary of the Navy.
1.21 “Navy License Agreement” means the Exclusive License Agreement between Repligen and the United States Department of the Navy at the Naval Medical Research Center (signed by Repligen on December 19, 2003) relating to U.S. Patent Application 08/385,194 and any amendments thereto.
1.22 “Net Sales” means, as to each Calendar Quarter, the gross invoiced sales prices charged for all Product sold in the U.S. during such Calendar Quarter, by or for BMS, its Affiliates and Sublicensees to Third Parties, after deduction (if not already deducted in the amount invoiced and only to the extent that such sums are otherwise included in the gross invoiced sales price) of the following items actually incurred by BMS, its Affiliates or Sublicensees during such Calendar Quarter with respect to such sales of Product in that Calendar Quarter:
(a) trade, cash, and/or quantity discounts, retroactive price reductions, charge-back payments and rebates actually taken and allowed, including discounts or rebates to governmental or managed care organizations;
(b) credits or allowances given or recorded for rejection or return of previously sold Product (including, without limitation, returns of Product in connection with recalls or withdrawals);
(c) any tax, tariff, duty or government charge (including any tax such as a value added or similar tax or government charge other than an income tax) levied on the sale, transportation or delivery of a Product and borne by the seller thereof without reimbursement from any third party;
(d) freight out, postage, shipping and insurance charges for delivery of such Product if separately set out on the invoice; and
(e) amounts written off by reason of uncollectible debt.
Net Sales and all of the foregoing deductions from the gross invoiced sales prices of Product shall be determined in accordance with BMS’s standard accounting procedures and in accordance with GAAP. In the event that BMS, its Affiliates or Sublicensees make any adjustments to such deductions after the associated Net Sales have been reported pursuant to this Agreement, the adjustments shall be reported and reconciled with the next report and payment of any royalties due under Article 4. A Product shall be considered “sold” when it is invoiced, shipped or paid for, whichever shall occur first.
In the case of any Combination Product sold in the U.S., Net Sales for such Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B) where A is the invoice price of the Product if sold separately without the other active ingredient(s), and B is the total invoice price of the other active ingredient(s) in the Combination Product, if sold separately. If such other active ingredient(s) in the Combination Product are not sold separately, Net Sales for the purpose of determining royalties of the Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/D, where A is the invoice price of the Product if sold separately, and D is the invoice price of the Combination Product. If neither the Product nor such other active ingredient(s) is sold separately, the Parties shall in good faith, determine Net Sales for such Combination Product by mutual agreement.
For avoidance of doubt, Net Sales shall be determined as set forth above based on sales of the Product in the U.S. only. Sales of Product outside of the U.S. shall not be included in the determination of Net Sales.
1.23 “Other Patents” means, with respect to each Licensor, all Patents Controlled by such Licensor as of the Effective Date, other than the Xxxxxxxx Patent Rights, upon which such Licensor (or any Third Party obtaining rights to such Patents) could assert, now or in the future, a claim of infringement based on the manufacture, use, sale, offer for sale, exportation and/or importation of any Licensed CTLA4 Product. For clarity, Other Patents shall include: (i) all Patents filed after the Effective Date which claim priority to any of the foregoing Patents, to the extent they cover subject matter disclosed and/or claimed in the foregoing Patents; and (ii) any patent(s), other than the Xxxxxxxx Patent Rights, issuing anywhere in the world from any application (including, but not limited to, divisionals, continuations, continuations-in-part and renewals) that (1) is pending on or after the Effective Date and (2) claims priority (directly or indirectly) to the application from which U.S. Patent No. 6,685,941 issued or any application to which U.S. Patent No. 6,685,941 claims priority, wherein the manufacture, use, sale, offer for sale, exportation and/or importation of any Licensed CTLA4 Product would infringe an issued claim or claims thereof.
1.24 “Party” means either Repligen, UM or BMS. “Parties” means collectively Repligen, UM and BMS.
1.25 “Patents” means (a) patents and patent applications in any country or jurisdiction, (b) all direct and indirect priority applications, divisionals, continuations, and continuations-in-part of any of the foregoing, and (c) all patents issuing on any of the foregoing patent applications; together with all registrations, reissues, renewals, re-examinations, confirmations, supplementary protection certificates and extensions, and applications therefor, of any of (a), (b) or (c).
1.26 “Pending Action” means the action pending as of the Effective Date between the Parties in the United States District Court for the Eastern District of Texas, Case No. 2:06-cv-4-TJW, relating to U.S. Patent No. 6,685,941.
1.27 “Person” means any individual, firm, corporation, partnership, limited liability company, trust, business trust, joint venture company, governmental authority, association or other entity.
1.28 “Product” means a fusion protein that contains the extracellular domain of the human CTLA4, where such protein binds to CD80 (B7-1) and/or CD86 (B7-2), and any pharmaceutical product that contains such a protein in any form, formulation, dosage or presentation. Pharmaceuticals that contain the same active ingredient shall be considered the same “Product” as one another even if marketed for different indications. Product shall exclude Belatacept and pharmaceutical products containing Belatacept. Product shall include Abatacept and the pharmaceutical product containing Abatacept being sold by BMS under the trademark ORENCIA®.
1.29 “Prosecution and Maintenance” means (a) preparing, filing and prosecuting patent applications (including, but not limited to, reissue, reexamination, continuation, continuation-in-part, divisional, and substitute applications and any foreign counterparts thereof, and extensions of the foregoing); (b) maintaining patent applications and patents; and (c) managing interferences, oppositions or similar administrative proceedings relating to any of the foregoing, and any civil action relating to the inventorship, validity or patentability of a patent or patent application that does not include a claim of patent infringement (including, but not limited to, the preparation and filing of all documents and participation in all oral hearings in connection with all the foregoing).
1.30 “Repligen” means Repligen Corporation and its Affiliates.
1.31 “Royalty Term” means the period beginning on January 1, 2008 and ending on the earlier of (i) December 31, 2013 or (ii) at such time that all claims of U.S. Patent No. 6,685,941 have been disclaimed, abandoned, lapsed or dedicated to the public or held revoked, unenforceable, unpatentable or invalid (whether through reexamination, reissue, opposition or otherwise) by a decision of a court or governmental agency of competent jurisdiction, which decision is unappealable or unappealed within the time allowed for appeal, provided that such decision does not result from any action taken by BMS or any Person acting on the behalf of, with the assistance of, or in concert with BMS.
1.32 “Sublicensee” means any Third Party which is sublicensed by BMS or any of its Affiliates to market and sell Product, but shall not include any wholesaler or distributor.
1.33 “Territory” means the entire world.
1.34 “Third Party” means any Person other than Repligen and its Affiliates, UM and BMS and BMS’s Affiliates.
1.35 “Xxxxxxxx Patent Rights” means (i) U.S. Patent No. 6,685,941 issued February 3, 2004; (ii) any foreign counterpart of U.S. Patent No. 6,685,941, (iii) any patent(s) issuing anywhere in the world from any application (including, but not limited to, divisionals, continuations, continuations-in-part and renewals) claiming priority (directly or indirectly) to U.S. Patent No. 6,685,941, PCT/US93/03155, PCT/US94/06701, U.S. Ser. No. 08/385,194, U.S. Ser. No. 08/076,071, U.S. Ser. No. 12/044,679 and/or U.S. Ser. No. 10/714,055; (iv) any patents that are reissues, reexaminations, extensions, or foreign counterparts of any of the foregoing; and (v) any application from which any of the foregoing patents issue; in each case for clauses (ii) through (v), to the extent that such application or patent covers the manufacture, use, sale, offer for sale, exportation and/or importation of any Licensed CTLA4 Product.
1.36 “UM” means The Regents of the University of Michigan.
1.37 “U.S.” and “United States” means the United States of America, including its territories and possessions.
1.38 “Written Approval Letter” means the written letter agreement between Repligen and the Navy dated April 7, 2008.
ARTICLE 2
LICENSE GRANT, SETTLEMENT AND RELEASE
2.3 Release and Non-Assertion by Licensors.
(a) In consideration of and subject to the terms and conditions of this Agreement and effective immediately after receipt into Repligen’s account of the funds subject to the wire payment referred to in Section 3.1 below, each Licensor, on behalf of itself and its Licensor Releasors, hereby releases BMS and the BMS Released Parties from any and all claims, demands and rights of action that such Licensor and its Licensor Releasors may have on account of any infringement of any Licensed Patent Controlled by such Licensor (including but not limited to the Xxxxxxxx Patent Rights) that occurred prior to the Effective Date as a result of the manufacture, use, offer for sale, sale, exportation and/or importation of Licensed CTLA4 Product.
(b) In consideration of and subject to the terms and conditions of this Agreement and effective immediately after receipt into Repligen’s account of the funds subject to the wire payment referred to in Section 3.1 below, each Licensor, on behalf of itself and its Licensor Releasors, covenants not to either directly or indirectly make, file or maintain any claim, demand, lawsuit, action or cause of action, of whatever kind or character, in law or in equity (collectively, a “Claim”) against BMS or any BMS Released Parties, jointly or severally, which Claim asserts that the manufacture, use, sale, offer for sale, import and/or export of Licensed CTLA4 Product infringes any claim of a Licensed Patent Controlled by such Licensor (including but not limited to the Xxxxxxxx Patent Rights).
(c) In consideration of and subject to the terms and conditions of this Agreement and effective immediately after receipt into Repligen’s account of the funds subject to the wire payment referred to in Section 3.1 below, each Licensor, on behalf of itself and its Licensor Releasors, hereby forever releases BMS and the BMS Released Parties from any and all claims asserted, or that could have been asserted, in the Pending Action.
2.4 Release and Non-Assertion by BMS.
(a) In consideration of and subject to the terms and conditions of this Agreement and effective immediately after receipt into Repligen’s account of the funds subject to the wire payment referred to in Section 3.1 below, BMS, on behalf of itself and its BMS Releasors, hereby releases Licensors and the Licensor Released Parties from any and all claims, demands and rights of action that BMS and its BMS Releasors may have related to the Xxxxxxxx Patent Rights that arose prior to the Effective Date.
(b) In consideration of and subject to the terms and conditions of this Agreement and effective immediately after receipt into Repligen’s account of the funds subject to the wire payment referred to in Section 3.1 below, BMS, on behalf of itself and its BMS Releasors, covenants not to either directly or indirectly make, file or maintain any claim, demand, lawsuit, action or cause of action, of whatever kind or character, in law or in equity, (including by way of example litigation or administrative proceedings such as reexamination or opposition), challenging the validity or patentability of U.S. Patent 6,685,941 (collectively, a “Patent Challenge”), or assist or act in concert with any Third Party making any such Patent Challenge.
(c) In consideration of and subject to the terms and conditions of this Agreement and effective immediately after receipt into Repligen’s account of the funds subject to the wire payment referred to in Section 3.1 below, BMS, on behalf of itself and the BMS Releasors, hereby forever releases Licensors and the Licensor Released Parties from any and all claims asserted, or that could have been asserted, in the Pending Action.
ARTICLE 3
1.8% of annual Net Sales less than or equal to $500 million;
2% of annual Net Sales greater than $500 million and less than or equal to $1 billion;
4% of annual Net Sales greater than $1 billion.
Royalties shall be calculated using the applicable royalty rate or rates set out above and shall be determined based on the annual Net Sales of the Product for the Calendar Year in question, and shall be paid at the rate applicable to the portion of Net Sales within each of the above Net Sales tiers during such Calendar Year. By way of example, for a Product in a given Calendar Year period, if the total Net Sales of such Product in such Calendar Year period is $1.2 billion, the royalty payable by BMS to Repligen will be (1.8% x $500 million) + (2% x $500 million) + (4% x $200 million) = $27 million.
3.3 Sales To or Between BMS, its Affiliates and Sublicensees. No royalties shall be paid upon sales or transfer of Product to or between any of BMS, its Affiliates, and Sublicensees for further sale, provided that in such case royalties shall be owed upon such further sale of Product in the U.S. by BMS, its Affiliates or Sublicensees to the first independent Third Party.
3.4 No Credit Against Royalties. BMS shall not be entitled to deduct any portion of royalties paid to any third party from the royalties due to Repligen pursuant to this Agreement for any reason.
3.5 One Royalty. Only one royalty shall be payable under this Agreement with respect to the same unit of Product.
the end of the Royalty Term, BMS will have no further obligation to make any royalty payments to Repligen under this Agreement and the royalty-bearing licenses and rights granted to BMS by Licensors under this Agreement shall then become fully paid-up and irrevocable, provided that all royalty payments due during the Royalty Term have been paid and the Agreement has not been terminated by any Party prior to the end of the Royalty Term, subject to Article 7.
ARTICLE 4
Citibank, 000 Xxxx Xxxxxx, Xxx Xxxx, XX
ABA # 000000000
A/C Bear Xxxxxxx
A/C # 09253186
Sub A/C : Repligen Corporation
Sub A/C # 220-12132
or such account of Repligen in such bank as Repligen may from time to time designate in writing. All royalty payments shall be free and clear of any taxes, duties, levies, fees or charges.
and shall simply report the amount, if any, by which BMS has overpaid or underpaid its royalty payments and an explanation of how or why the overpayment or underpayment occurred. If such public accountant correctly concludes that BMS’s royalty payments are in error such that royalties to Repligen were underpaid, then BMS shall promptly (in any event within 20 Business Days) pay the deficiency plus interest pursuant to Section 4.3 to Repligen; and if royalties to Repligen were underpaid by more than seven-and-a-half percent (7.5%) of the total royalty obligation, then BMS shall additionally reimburse Repligen for its reasonable costs incurred in examining such records. Any overpayments by BMS in the three (3) year period immediately preceding the request for such examination shall be fully creditable against amounts payable in subsequent payment periods. If no such amounts become payable following the delivery of such report or if such amounts cannot be credited against amounts payable in subsequent payment periods owing to expiration or termination of this Agreement, then no refund shall be due. In no event shall BMS be entitled to any credit for any overpayment of royalties that occurred prior to such three (3) year period.
ARTICLE 5
REPRESENTATIONS, WARRANTIES, AND DISCLAIMERS
5.2 Representations and Warranties of Licensor. Each Licensor represents and warrants to BMS that:
(a) it has the full right, power, and corporate authority to enter into this Agreement and to make the covenants and grant the rights and licenses set forth in this Agreement, and that this Agreement is enforceable against it in accordance with its terms;
(b) UM and the Navy are the joint owners of all right, title, and interest in and to U.S. Patent No. 6,685,941;
(c) Repligen is the exclusive licensee with respect to Xxxxxxxx Patent Rights and Licensors jointly have the full legal right, power and ability to extend the rights and grant the exclusive licenses in, to and for the Xxxxxxxx Patent Rights to BMS as set forth in this Agreement;
(d) Licensor is not a party to any agreement or other binding commitment or obligation of any kind, the terms of which (i) conflict with the covenants and obligations of Licensor under this Agreement or the rights granted by Licensor to BMS under this Agreement or (ii) derogates from the rights granted by Licensor to BMS in this Agreement or the ability of Licensor to perform its covenants and obligations under this Agreement;
(e) except for the exclusive license granted by UM to Repligen, and the rights of HHMI under Section 2.2 of the License Agreement dated July 24, 2000 between Repligen and UM, as of the Effective Date, no Third Party holds any license and/or any option for a license and/or the grant of a covenant not to xxx, from UM with respect to the Xxxxxxxx Patent Rights;
(f) as of the Effective Date, no Third Party holds any license and/or any option for a license and/or the grant of a covenant not to xxx, from Repligen with respect to the Xxxxxxxx Patent Rights,
(g) it will not after the Effective Date enter into any agreements, contracts or other arrangements, or relinquish any rights, that would be inconsistent with or in conflict with or in derogation of BMS’s rights and licenses under this Agreement or Licensor’s obligations under this Agreement, except as provided in Section 8.1 and without limiting Section 8.2;
(h) Xxxxx X. Xxxxxxxx (co-inventor of U.S. Patent No. 6,685,941) has assigned all of his rights with respect to the Xxxxxxxx Patent Rights to UM;
(i) Xxxx X. June (co-inventor of U.S. Patent No. 6,685,941) has assigned all of his rights with respect to the Xxxxxxxx Patent Rights to The United States of America as represented by the Secretary of the Navy and/or UM;
(j) Repligen and/or UM has entered into enforceable written agreement(s) with the Navy granting to Repligen exclusive rights with respect to the rights and interest of Xxxx X. June and the Navy with respect to the Xxxxxxxx Patent Rights which enables Licensors to grant the exclusive license to BMS under this Agreement, subject only to the rights retained by the Navy in accordance with the terms with the Navy License Agreement as modified by the Written Approval Letter;
(k) no Third Party has any rights to enforce the Xxxxxxxx Patent Rights;
(l) it has not entered into any agreements, or relinquished any rights, related to the Xxxxxxxx Patent Rights or Other Patents between March 5, 2008 and the Effective Date of this Agreement, with any Third Party, other than the Navy and except as provided in Section 8.1;
(m) it will maintain, fully perform its obligations and will not relinquish any of its rights under any agreements existing as of the Effective Date granting or transferring any rights to it with respect to the Xxxxxxxx Patent Rights or Other Patents, except as provided in Section 8.1 and without limiting Section 8.2;
(n) with respect to any and all agreements of Licensor through which Licensor has acquired or holds any rights to the Xxxxxxxx Patent Rights: the rights under each such agreement are and shall remain in full force and effect; Licensor has not committed any act or failed to do any act that would constitute a breach of the agreement or provide any Person with a right to terminate the agreement; and Licensor will provide BMS with any notice of default or deficiency received from any party to the agreement at least 20 days prior to the expiration of any period allowed to cure the default or deficiency, and thereafter BMS shall have the right (but not the obligation or responsibility) to cure the alleged default or deficiency and to deduct any payment made for that purpose from the next royalty payment(s) due to Repligen under Article 3 but only if such default or deficiency is cured through a monetary payment;
(o) prior to the Effective Date it has obtained any necessary approval from HHMI to enter into and grant the rights and licenses to BMS under this Agreement; and
(p) prior to the Effective Date Repligen has provided BMS with a copy of the Written Approval Letter.
5.3 Disclaimer. Nothing in this Agreement is or shall be construed as:
(a) a warranty or representation by Licensor as to the validity, enforceability, or scope of any claim or patent or patent application within the Licensed Patents in the Territory;
(b) subject to the representations and warranties of Licensor under Section 5.2, a warranty or representation by Licensor that anything made, used, sold, or otherwise disposed of under any
license granted in this Agreement is or will be free from infringement of any patent rights or other intellectual property right of any Third Party;
(c) a grant by Licensor, whether by implication, estoppel, or otherwise, of any licenses or rights, under any patent or patent application, or under any know-how or other right, other than that expressly granted under Article 2;
(d) an obligation by any Party to bring or prosecute actions or suits against any Third Party for infringement of any of the Licensed Patents; or
(e) a representation or acknowledgement by BMS that any claim of any patent or patent application within the Licensed Patents is or has been infringed by any product or activity.
5.5 IN NO EVENT SHALL ANY PARTY, INCLUDING THEIR REGENTS, FELLOWS, OFFICERS, EMPLOYEES AND AGENTS, BE RESPONSIBLE OR LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES OR LOST PROFITS, LOSS OF OPPORTUNITY, OR OTHER ECONOMIC LOSS OR DAMAGE WITH RESPECT TO ANY CAUSE OF ACTION ARISING OUT OF THIS AGREEMENT, REGARDLESS OF LEGAL OR EQUITABLE THEORY, PROVIDED, HOWEVER, THAT (i) NOTHING IN THIS SECTION 5.5 SHALL IN ANY WAY MODIFY OR OTHERWISE AFFECT BMS’S OBLIGATION TO PAY ROYALTIES IN ACCORDANCE WITH THE PROVISIONS OF THIS AGREEMENT, NOR LIMIT LICENSORS’ RIGHT TO SEEK AND RECOVER FULL DAMAGES FOR ANY UNPAID ROYALTIES FROM BMS, ITS AFFILIATES OR SUBLICENSEES AND (ii) THERE SHALL BE NO LIMITATION ON AVAILABLE REMEDIES AND THIS SECTION 5.5 SHALL NOT APPLY WITH RESPECT TO ANY CAUSE OF ACTION BASED ON THE WILLFUL, INTENTIONAL, RECKLESS AND/OR GROSSLY NEGLIGENT BREACH OF ANY OBLIGATION, REPRESENTATION, WARRANTY AND/OR COVENANT UNDER THIS AGREEMENT BY A PARTY.
ARTICLE 6
ARTICLE 7
BMS of any terms and conditions of this Agreement, provided that such breach has not been cured within ninety (90) business days after written notice thereof is given by Repligen to BMS specifying the nature of the alleged breach.
ARTICLE 8
PATENT PROSECUTION AND ENFORCEMENT
8.1 Prosecution and Maintenance of the Xxxxxxxx Patents Rights. Subject to Section 8.2 and without limiting any rights of BMS that may exist separately from this Agreement, the Licensors retain control of Prosecution and Maintenance of Licensed Patents, and agree to maintain any issued patent within the Xxxxxxxx Patent Rights at the expense of the Licensors by timely paying any applicable government imposed maintenance fees. Any costs associated with Prosecution and Maintenance of applications within the Licensed Patents shall be borne by the Licensors, except as provided in Section 8.2. Notwithstanding the foregoing, the Parties agree that Licensors will abandon the following applications:
U.S. Serial No. 12/044,679; JP 2006-284411; CA 2,133,075; and EP 4015607.7 (published as EP1488805A).
ARTICLE 9
fiduciary relationship between the Parties. No Party shall incur any debts or make any commitments for the other.
9.8 Governing Law. This Agreement shall be governed by, enforced, and shall be construed in accordance with the laws of the State of Delaware without regard to its conflicts of law provisions. For the purposes of any suit, action or other proceeding arising out of, or under or in connection with this Agreement, the Parties are free to agree or not agree to the form of such proceeding, whether litigation or
arbitration, provided that, in the event that any suit, action or other proceeding is to be submitted to a court (whether as agreed upon by all Parties or, in the absence of an agreement, through any one of them), the Parties hereby will irrevocably submit to the jurisdiction of (i) the United States District Court for the Eastern District of Texas or the United States District Court for the District of Delaware (each a “District Court”), and otherwise to the exclusive jurisdiction of (ii) the Supreme Court or Chancery Court of the State of Delaware (each a “State Court”) . Each Party agrees to commence any such action, suit or proceeding in such District Court or if such suit, action or other proceeding may not be brought in such court for jurisdictional reasons, in a State Court. Each Party further agrees that service of any process, summons, notice or document by certified mail, return receipt requested, to such Party’s respective address set forth below in Section 9.9 shall be effective service of process for any action, suit or other proceeding with respect to any matters to which it has submitted to jurisdiction in this Section. Each Party irrevocably and unconditionally waives any defense or objection to the laying of venue of any action, suit or other proceeding arising out of this Agreement in (i) a State Court, or (ii) the District Court, and hereby and thereby further irrevocably and unconditionally waives and agrees not to plead or claim any defense or objection in any such court that any such action, suit or other proceeding brought in any such court has been brought in an inconvenient forum.
If to BMS, addressed to:
Xxxxxxx-Xxxxx Squibb Company
X.X. Xxx 0000
Xxxxx 000 & Province Line Road
Princeton, NJ 08543-4000
Attention: Senior Vice President, Corporate and Business Development
With a copy to:
Xxxxxxx-Xxxxx Squibb Company
X.X. Xxx 0000
Xxxxx 000 & Province Line Road
Princeton, NJ 08543-4000
Attention: Vice President & Senior Counsel, Business Development
If to Repligen, addressed to:
Repligen Corporation
00 Xxxxx Xxxxxx
Xxxxxxxx #0, Xxxxx 000
Xxxxxxx, XX 00000
Attention: President and Chief Executive Officer
If to UM, addressed to:
University of Michigan
Office of Technology Transfer
0000 X. Xxxxxxxxxx Xxx., 0xx Xxxxx
Xxx Xxxxx, XX 00000-0000
(a) Each of the Parties acknowledges and agrees that this Agreement has been diligently reviewed by and negotiated by and between them, that in such negotiations each of them has been represented by competent counsel and that the final agreement contained herein, including the language whereby it has been expressed, represents the joint efforts of the Parties hereto and their counsel. Accordingly, in interpreting this Agreement or any provision hereof, no presumption shall apply against any Party hereto as being responsible for the wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.
(b) The definitions of the terms herein shall apply equally to the singular and plural forms of the terms defined. Whenever the context may require, any pronoun shall include the corresponding masculine, feminine and neuter forms. The words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation”. The word “will” shall be construed to have the same meaning and effect as the word “shall”. The word “any” shall mean “any and all” unless otherwise clearly indicated by context.
(c) Unless the context requires otherwise, (i) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein), (ii) any reference to any laws herein shall be construed as referring to such laws as from time to time enacted, repealed or amended, (iii) any reference herein to any Person shall be construed to include the Person’s successors and assigns, (iv) the words “herein”, “hereof” and “hereunder”, and words of similar import,
shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof, and (v) all references herein to Articles or Sections, unless otherwise specifically provided, shall be construed to refer to Articles and Sections of this Agreement.
(d) Headings and captions are for convenience only and are not be used in the interpretation of this Agreement.
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REPLIGEN CORPORATION | ||||
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THE REGENTS OF THE UNIVERSITY OF MICHIGAN | ||||
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XXXXXXX-XXXXX SQUIBB COMPANY | ||||
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EXHIBIT A
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF TEXAS
MARSHALL DIVISION
REPLIGEN CORPORATION and THE REGENTS OF THE UNIVERSITY OF MICHIGAN,
Plaintiffs,
x.
XXXXXXX-XXXXX SQUIBB COMPANY,
Defendant. | Case No. 2:06-cv-4-TJW |
STIPULATION OF DISMISSAL
WHEREAS Plaintiffs Repligen Corporation and The Regents of the University of Michigan (collectively “Plaintiffs”) and Defendant Xxxxxxx-Xxxxx Squibb Company (“Bristol”), as indicated by the signature of counsel appearing below, have agreed to the dismissal of this action, pursuant to Federal Rule of Civil Procedure 41 and subject to the terms of this Order and a settlement agreement, dated April __, 2008,
NOW, THEREFORE, it is ordered as follows:
1. | The claims by Plaintiffs against Bristol are hereby dismissed with prejudice. |
2. | The claims by Bristol against Plaintiffs are hereby dismissed with prejudice. |
3. | Each party shall bear its own costs and attorneys fees attributable to the prosecution and defense of the claims. |
STIPULATED AND AGREED
BY: |
| BY: |
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Xxxxxx X. Xxxxxx (Bar No. 01938000) XxXXXX XXXXX P.C. 000 Xxxx Xxxxxx Xxxxxx, Xxxxx 000 Xxxxxxxx, Xxxxx 00000 (903) 927-2111 (000) 000-0000 (facsimile)
OF COUNSEL:
Xxxx Xxxxxxx (Bar No. 24043681) XxXXXX XXXXX P.C. 000 X. 0xx Xxxxxx, Xxxxx 0000 Xxxxxx XX 00000 (512) 692.8731 (000) 000.0000
Xxxxx X. Xxxxx FISH & XXXXXXXXXX P.C. 0000 X Xxxxxx, X.X., 00xx Xxxxx Xxxxxxxxxx, XX 00000 (202) 783-5070 (000) 000-0000 (facsimile)
Xxxxxxx Xxxxxx FISH & XXXXXXXXXX P.C. 00000 Xx Xxxxxx Xxxx Xxx Xxxxx, XX 00000 (858) 678-5070 (000) 000-0000 (facsimile)
Xxxxxx X. Xxxxxxx Xxxxx Xxxxxxxx Xxxxxxx X. Xxxxxxxx | Xxxxxx X. Xxxxxxxxx Lead Attorney for Defendant Xxxxxxx-Xxxxx Squibb Company XXXXXXXXXXX XXXXX XXXXXX & XXXXXX 00 Xxxxxxxxxxx Xxxxx Xxx Xxxx, X.X. 00000 Telephone: (000) 000-0000 Facsimile: (000) 000-0000 xxxxxxxxxx@xxxx.xxx
OF COUNSEL:
Xxxxx X. Xxxx xxxxx@xxxx.xxx Xxxxxxx Xxxxx xxxxxx@xxxx.xxx Xxxxxxxxxxx X. Xxxxxxx xxxxxxxx@xxxx.xxx XXXXXXXXXXX XXXXX XXXXXX & XXXXXX 00 Xxxxxxxxxxx Xxxxx Xxx Xxxx, X.X. 00000 Telephone: (000) 000-0000 Facsimile: (000) 000-0000
J. Xxxxxx Xxxx Texas Bar No. 24032294 IRELAND XXXXXXX & XXXXXX, P.C. 0000 Xxxxx Xxxxxxxx Xxxxx, Xxxxx 00000 Telephone: (000) 000-0000 Facsimile: (000) 000-0000 xxxxxxxxxx@xxxxxx.xxx | |||||||||
FISH & XXXXXXXXXX P.C. | Attorneys For Defendant, XXXXXXX-XXXXX SQUIBB | |||||||||
000 Xxxxxxxx Xxxxxx | XXXXXXX | |||||||||
Xxxxxx, XX 00000 | ||||||||||
(000) 000-0000 | ||||||||||
(000) 000-0000 (facsimile) | ||||||||||
Attorneys For Plaintiffs REPLIGEN CORPORATION and REGENTS OF THE UNIVERSITY OF MICHIGAN | ||||||||||
SO ORDERED this day of , 2008. |
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Honorable T. Xxxx Xxxx |
EXHIBIT B
Press Release
Repligen Corporation | ||||
00 Xxxxx Xxxxxx | ||||
XxxxxXxx | Xxxxxxxx #0, Xxxxx 000 | |||
Xxxxxxx, Xxxxxxxxxxxxx 00000 | ||||
Telephone: 000-000-0000 | ||||
FOR IMMEDIATE RELEASE | Telefax: 000-000-0000 |
CONTACT:
Xxxxxx X. Xxxxxxx, Ph.D. President and Chief Executive Officer (000) 000-0000 | Xxxxx Xxxxxxxxxx Vice President, Market Development (000) 000-0000 |
Repligen Announces Settlement with Xxxxxxx-Xxxxx Squibb in Orencia®
Lawsuit
WALTHAM, MA – April , 2008 – Repligen Corporation (NASDAQ: RGEN) announced today that it has reached a settlement with Xxxxxxx-Xxxxx Squibb Company (NYSE: BMY) in its lawsuit alleging infringement of U.S. Patent No. 6,685,941 (“the ‘941 patent”), based on Xxxxxxx-Xxxxx Squibb’s sale of Orencia® for the treatment of rheumatoid arthritis. The settlement provides for Xxxxxxx-Xxxxx Squibb to make an initial payment of $5,000,000 and to pay royalties on the U.S. net sales of Orencia® for any clinical indication at a rate of 1.8% for the first $500,000,000 of annual sales, 2.0% for the next $500,000,000 of annual sales and 4% of U.S. annual sales in excess of $1 billion for each year from January 1, 2008 until December 31, 2013. The settlement also provides for the grant by Repligen and co-plaintiff the University of Michigan to Xxxxxxx-Xxxxx Squibb of an exclusive worldwide license under certain patent rights of Repligen and the University of Michigan. The settlement serves as the basis for Repligen and co-plaintiff the University of Michigan to dismiss the lawsuit against Xxxxxxx-Xxxxx Squibb.
“We are very pleased by the settlement of this case which will provide us a substantial new source of revenue,” stated Xxxxxx X. Xxxxxxx, President and Chief Executive Officer of Repligen Corporation. “Based on analysts’ estimates of U.S. sales of Orencia®, we expect total cash receipts from our Protein A business, Orencia® royalties, research and development and other income of greater than $30 million for fiscal year 2009, beginning April 1, 2008.”
In January 2006, Repligen and the University of Michigan filed a complaint in the United States District Court for the Eastern District of Texas against Xxxxxxx-Xxxxx Squibb alleging infringement of the ‘941 patent based on its sale of Orencia®. The claims of the ‘941 patent relate to the use of CTLA4-Ig (Orencia®) for the treatment of specific auto-immune diseases, including rheumatoid arthritis. The ‘941 patent is owned by the University of Michigan and the United States Department of the Navy and is exclusively licensed to Repligen.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company focused on the development of novel therapeutics for diseases that affect the central nervous system. In addition, we are the world’s leading supplier of recombinant Protein A, the sales of which partially fund the advancement of our development pipeline while supporting our financial stability. Repligen’s corporate headquarters are located at 00 Xxxxx Xxxxxx, Xxxxxxxx #0, Xxxxx 000, Xxxxxxx, XX 00000. Additional information may be requested from xxx.xxxxxxxx.xxx.
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding current or future financial performance and position, management’s strategy, plans and objectives for future operations, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval, litigation, intellectual property, product development, manufacturing plans and performance such as the anticipated growth in the monoclonal antibody market and our other target markets and projected growth in product sales, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: the success of current and future collaborative relationships, the market acceptance of our products, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of product revenues and profits, our ability to generate future revenues, our ability to raise additional capital to continue our drug development programs, the success of our clinical trials, our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights for our products, the risk of litigation regarding our intellectual property rights, our limited sales and manufacturing capabilities, our dependence on third-party manufacturers and value added resellers, our ability to hire and retain skilled personnel, our volatile stock price, and other risks detailed in Repligen’s filings with the Securities and Exchange Commission. Repligen assumes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.