Sample Business Contracts

FOREGOING LIMITATIONS SHALL NOT APPLY TO ANY LIABILITY OF HPA OR ITS AFFILIATES RESULTING FROM THE MANUFACTURE AND SUPPLY OF LICENSED PRODUCTS OR OTHERWISE RELATING TO SECTIONS 2.9 AND 9.3(f). NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS ATTEMPTING TO EXCLUDE OR LIMIT THE LIABILITY OF EITHER OF THE PARTIES OR THEIR RESPECTIVE AFFILIATES (A) FOR DEATH OR PERSONAL INJURY CAUSED BY THE NEGLIGENCE OF EITHER OF THE PARTIES, THEIR RESPECTIVE AFFILIATES, OR OF THE OFFICERS, EMPLOYEES OR AGENTS OF THE PARTIES OR THEIR RESPECTIVE AFFILIATES, (B) FOR FRAUD OR FRAUDULENT MISREPRESENTATION OR (C) FOR ANY MATTER IN RESPECT OF WHICH IT WOULD BE ILLEGAL FOR EITHER PARTY TO EXCLUDE OR ATTEMPT TO EXCLUDE ITS LIABILITY.

          (b) SUBJECT TO THE PRECEDING SENTENCE, BUT NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, IN NO EVENT SHALL THE COMBINED AGGREGATE LIABILITY OF EITHER PARTY UNDER THIS AGREEMENT, TAKEN TOGETHER WITH SUCH PARTY’S AGGREGATE LIABILITY UNDER THE BT LICENSE AGREEMENT, THE rBOT LICENSE AGREEMENT, THE rBOT DEVELOPMENT AGREEMENT AND THE DISTRIBUTION AGREEMENT, EXCEED THE COMBINED AGGREGATE AMOUNTS PAID BY EMERGENT TO HPA, WHETHER AS LUMP SUMS OR PERIODIC PAYMENTS OF ROYALTIES OR SUBLICENSE INCOME, UNDER THIS AGREEMENT, THE BT LICENSE AGREEMENT, THE rBOT LICENSE AGREEMENT, THE rBOT DEVELOPMENT AGREEMENT AND THE DISTRIBUTION AGREEMENT (THE “AGGREGATE AMOUNT”); PROVIDED, HOWEVER, THAT IN THE EVENT THAT EITHER PARTY (THE “LIABLE PARTY”) SHALL BECOME LIABLE TO THE OTHER PARTY HEREUNDER OR THEREUNDER FOR AN AMOUNT (THE “TOTAL LIABILITY”) LARGER THAN THE AGGREGATE AMOUNT CALCULATED AS OF THE DATE THAT THE TOTAL LIABILITY BECAME DUE AND PAYABLE, THE LIABLE PARTY SHALL PROMPTLY PAY SUCH OTHER PARTY A LUMP SUM EQUAL TO THE AGGREGATE AMOUNT AS SO CALCULATED; AND PROVIDED, FURTHER, THAT IF HPA IS THE LIABLE PARTY, EMERGENT SHALL THEREAFTER HAVE A RIGHT OF OFFSET WITH RESPECT TO ANY PAYMENT OBLIGATIONS OF EMERGENT TO HPA HEREUNDER AND THEREUNDER THAT BECOME DUE AND PAYABLE AFTER SUCH DATE, UNTIL SUCH TIME AS THE TOTAL AMOUNTS OFFSET BY EMERGENT EQUAL THE DIFFERENCE BETWEEN THE TOTAL LIABILITY AND SUCH LUMP SUM PAYMENT BY HPA; AND PROVIDED, FURTHER, THAT IF EMERGENT IS THE LIABLE PARTY, THEN THEREAFTER, AT SUCH TIMES AS EMERGENT SHALL MAKE PAYMENTS TO HPA THAT ARE OTHERWISE DUE AND PAYABLE HEREUNDER OR THEREUNDER, EMERGENT SHALL PAY TO HPA AN EQUAL AMOUNT AS ADDITIONAL DAMAGES, UNTIL SUCH TIME AS THE TOTAL AMOUNTS SO PAID TO HPA AS ADDITIONAL DAMAGES EQUAL THE DIFFERENCE BETWEEN THE TOTAL LIABILITY AND SUCH LUMP SUM PAYMENT BY EMERGENT.

     8.5 Insurance. Emergent shall use commercially reasonable efforts to obtain and maintain, with an insurance company of internationally recognized standing, such type and amounts of liability insurance, and HPA shall maintain such program of self-insurance, in each case covering the development of the Licensed Product(s), as is normal and customary in the pharmaceutical industry generally for parties similarly situated, and Emergent shall upon request

provide HPA with a copy of such policies of insurance, along with any amendments and revisions thereto; provided, however, that Emergent shall promptly notify HPA in writing if, after using commercially reasonable efforts, Emergent is unable to obtain such insurance or if, after obtaining such insurance, Emergent is unable to maintain such insurance; and provided, further, that Emergent shall not be required to seek such insurance coverage to the extent that the relevant liabilities are covered by a government indemnity in favor of Emergent or precluded by applicable law.

ARTICLE IX
Representations and Warranties

     9.1 Representations and Warranties. Each Party hereby represents, warrants and covenants to the other Party as of the Effective Date as follows:

          (a) Such Party (i) has the power and authority and the legal right to enter into this Agreement and perform its obligations hereunder, and (ii) has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid and binding obligation of such Party and is enforceable against it in accordance with its terms subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity.

          (b) Such Party is not aware of any pending or threatened litigation (and has not received any communication) that alleges that such Party’s activities related to this Agreement have violated, or that by conducting the activities as contemplated herein such Party would violate, any of the intellectual property rights of any other Person.

          (c) All necessary consents, approvals and authorizations of all regulatory and governmental authorities and other Persons required to be obtained by such Party in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder have been obtained.

          (d) The execution and delivery of this Agreement and the performance of such Party’s obligations hereunder (i) do not conflict with or violate any requirement of applicable law or regulation or any provision of the articles of incorporation, bylaws, limited partnership agreement or any similar instrument of such Party, as applicable, in any material way, and (ii) do not conflict with, violate, or breach or constitute a default or require any consent under, any contractual obligation or court or administrative order by which such Party is bound.

     9.2 Additional Representations, Warranties and Covenants of Emergent. Emergent represents, warrants and covenants to HPA that Emergent is a corporation duly organized and in good standing under the laws of the State of Delaware, and has full power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement.

     9.3 Additional Representations, Warranties and Covenants of HPA. HPA represents, warrants and covenants to Emergent that:

          (a) HPA is a governmental entity duly organized, validly existing and in good standing under the laws of England, and has full governmental power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement.

          (b) HPA has conducted any and all studies and other development work related to the Licensed Product(s), including any such work performed pursuant to the Master Services Agreement, in accordance with Applicable Law. HPA and its Affiliates have employed (and, with respect to the Development Activities, will employ) Persons with appropriate education, knowledge and experience to conduct and to oversee the conduct of such activities with respect to the Licensed Products. Neither HPA nor any of its Affiliates is aware of any fact or circumstance that could adversely affect the acceptance, or the subsequent approval, by any Regulatory Authority of any filing, application or request for Regulatory Approval.

          (c) Neither HPA nor any of its Affiliates or Key Personnel have been debarred or are subject to debarment and neither HPA nor any of its Affiliates will use in any capacity, in connection with the services to be performed under this Agreement or that have previously provided pursuant to the Master Services Agreement, any Person who has been debarred pursuant to Section 306 of the FFDCA, or who is the subject of a conviction described in such section. HPA agrees to inform Emergent in writing immediately if it or any Person who is performing services hereunder or the Master Services Agreement is debarred or is the subject of a conviction described in Section 306, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of HPA’s knowledge, is threatened, relating to the debarment or conviction of HPA or any Person performing services hereunder or under the Master Services Agreement.

          (d) HPA agrees not to, and agrees to cause its Affiliates not to, directly or indirectly, expressly or by implication, by action or omission or otherwise (i) assign, transfer, convey or otherwise encumber any right, title or interest in or to the Regulatory Documentation or Joint Technology, (ii) grant any license or other right, title or interest in or to the Regulatory Documentation or Joint Technology in any manner, or (iii) agree to or otherwise become bound by any covenant not to sue for any infringement, misuse or other action or inaction with respect to the Regulatory Documentation or Joint Technology, in each case ((i), (ii), and (iii)) that is inconsistent with the grants, assignments and other rights reserved to Emergent and its Affiliates under this Agreement and the BT License Agreement.

          (e) HPA shall cause each of its Affiliates and any other Person conducting Development Activities on behalf of HPA hereunder to assign to HPA rights to any and all Information and Inventions that relate to the Licensed Product(s), such that Emergent shall, by virtue of this Agreement and the BT License Agreement, receive from HPA, without payment of additional consideration beyond that required by this Agreement and the BT License Agreement, the licenses and other rights granted to Emergent and its Affiliates hereunder and under the BT License Agreement.

          (f) At the time of delivery of each Licensed Product to Emergent pursuant to Section 2.9.2: (i) such Licensed Product will have been Manufactured, held and shipped in accordance with any applicable Regulatory Approvals for such Licensed Product, any applicable Good Manufacturing Practices and all other Applicable Law; (ii) such Licensed Product will have been manufactured in accordance, and be in conformity with, the product specifications for such Licensed Product (as set forth in the Development Plan) and will conform with any certificate of analysis provided by HPA; and (iii) title to such Licensed Product will pass to Emergent free and clear of any security interest, lien or other encumbrance.

     9.4 Disclaimer of Warranties. EXCEPT FOR THOSE WARRANTIES SET FORTH IN THIS ARTICLE IX, AND SUBJECT TO SECTION 8.4(a), EACH PARTY HEREBY DISCLAIMS ANY AND ALL WARRANTIES, CONDITIONS AND TERMS, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING (A) ANY WARRANTY OF QUALITY, PERFORMANCE, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE, (B) ANY WARRANTY WITH RESPECT TO THE VALIDITY OR ENFORCEABILITY OF ANY PATENT OR OTHER INTELLECTUAL PROPERTY, AND (C) ANY WARRANTY THAT THE PERFORMANCE OF ITS RIGHTS OR OBLIGATIONS HEREUNDER WILL NOT INFRINGE THE INTELLECTUAL PROPERTY RIGHTS OF ANY PERSON. SUBJECT TO SECTION 8.4(a), NO PARTY MAKES ANY REPRESENTATIONS HEREUNDER OTHER THAN THOSE SET FORTH EXPRESSLY HEREIN.

ARTICLE X
Intellectual Property Provisions

     10.1 Intellectual Property Ownership.

          10.1.1 Ownership of Emergent Technology and Regulatory Documentation. Subject to the license grant to HPA under Section 5.2(a), as between the Parties, Emergent shall own and retain all right, title and interest in and to the Emergent Technology. Subject to Applicable Law, as between the Parties, Emergent shall own all right, title and interest in and to the Regulatory Documentation (other than any Regulatory Documentation that HPA may develop at its expense solely in connection with the exercise of the Retained Rights).

          10.1.2 Ownership and Exploitation of Joint Inventions and Joint Technology. Subject to the license grants under Sections 5.1 and 5.2 and the BT License Agreement, Emergent and HPA shall each own an equal, undivided interest in the Joint Inventions and the Joint Technology. Each Party agrees to disclose to the other Party promptly in writing any and all Joint Inventions and Joint Technology that are conceived, discovered, developed, or otherwise made by or on behalf of such Party or its Affiliates or permitted subcontractors during the period beginning on the Effective Date and ending on the last day of the term of this Agreement, and to assign to such other Party (and to cause its Affiliates, employees and permitted subcontractors to assign to such other Party), without payment of additional consideration, an equal, undivided interest in such Joint Inventions or Joint Technology. The parties agree that (a) Emergent shall be free to Exploit any Joint Invention or Joint Technology in the Territory for any purpose, without an accounting to HPA, and (b) in addition to such rights as

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HPA has under Section 5.3, HPA shall be free to Exploit any Joint Inventions or Joint Technology in the Territory outside the Field.

     10.2 Prosecution of Patents.

          10.2.1 Emergent Patents. Emergent shall have the sole right, at its sole cost and expense, to obtain, prosecute and maintain any Patents covering or claiming the Emergent Technology in the Territory.

          10.2.2 Joint Patents. Emergent shall have the sole right to prepare, file, prosecute and maintain the Joint Patents in the Territory. HPA shall, and shall cause its Affiliates, to assist and cooperate with Emergent in filing, prosecuting and maintaining the Joint Patents, at Emergent’s cost. Subject to the following sentence, Emergent shall bear the costs and expenses of the filing, prosecution and maintenance of the Joint Patents. If Emergent elects not (a) to pursue the filing, prosecution or maintenance of a Joint Patent in a country, or (b) to take any other action with respect to a Joint Patent in a country that is necessary or useful to establish or preserve rights thereto, then in each such case ((a) and (b)) Emergent shall so notify HPA promptly in writing and in good time to enable HPA to meet any deadlines by which an action must be taken to establish or preserve any such rights in such Joint Patent in such country. Upon receipt of each such notice from Emergent, HPA shall have the right, but not the obligation, to pursue the filing or registration, or support the continued prosecution or maintenance, of such Joint Patent, at its expense in such country. If HPA elects to pursue such filing or registration, as the case may be, or continue such support, then HPA shall notify Emergent of such election and Emergent shall, and shall cause its Affiliates to, reasonably cooperate with HPA in this regard.

     10.3 Enforcement and Defense of Patents.

          10.3.1 Party Patents. Except as otherwise provided in this Article X or in the BT License Agreement, each Party shall have the sole right, at its own expense, but not the obligation to enforce its rights under any Patents against all infringers at its sole cost and expense, and shall be entitled to any amounts it may recover from the infringer, whether by settlement or judgment.

          10.3.2 Joint Patents. If either Party determines that any Joint Patent is being infringed by a Third Party’s activities and that such infringement could affect the exercise by Emergent of its rights and obligations under this Agreement, it shall notify the other Party in writing and provide it with any evidence of such infringement that is reasonably available. In the event that any Joint Patent is being infringed by a Third Party, Emergent shall have the sole and exclusive right, but not the obligation, to attempt to remove such infringement, including by filing an infringement suit or taking other similar action. HPA shall provide reasonable assistance to Emergent in the event that Emergent acts to enforce the Joint Patent with respect to such infringement, including by providing access to relevant documentation and other evidence, and joining the action to the extent necessary to allow Emergent to maintain the action. Emergent shall bear all costs and expenses with respect to any such enforcement, and shall be entitled to retain any amounts recovered, whether by settlement or judgment.

     10.4 Potential Infringement of Third Party Rights.

          10.4.1 Third Party Licenses. Each Party shall be responsible, in its sole discretion, (a) for determining whether to obtain any licenses from Third Parties in order to avoid infringing such Third Parties’ intellectual property rights in performing its obligations hereunder, (b) for obtaining such licenses, and (c) for bearing any costs incurred in connection with obtaining such licenses.

          10.4.2 Third Party Litigation. In the event that a Third Party commences litigation against a Party, its Affiliates or its sublicensees for infringement of such Third Party’s Patents or other intellectual property rights, such Party shall have the sole right to defend against such infringement suit. The other Party shall use all reasonable efforts to assist and cooperating with the defending Party in connection with the defense of such suit. Each Party shall bear its own costs and expenses with respect to the defense of any suit, including any judgments or settlement against it.

ARTICLE XI
Term and Termination

     11.1 Term and Expiration. This Agreement shall become effective as of the Effective Date and unless terminated earlier pursuant to Section 11.2, 11.3, 11.4, 11.5 or 11.7, the term of this Agreement shall continue in effect until the Development Activities are completed.

     11.2 Termination by Emergent without Cause. Notwithstanding anything contained herein to the contrary, Emergent shall have the right to terminate this Agreement at any time in its sole discretion by giving not less than two hundred and seventy (270) days’ written notice to HPA.

     11.3 Termination by HPA for Failure to Meet Minimum Commitment. In the event that Emergent fails to meet its Minimum Commitment obligation under Section 3.4, HPA shall have the right upon thirty (30) days’ written notice to Emergent to terminate this Agreement.

     11.4 Termination by Either Party for Material Breach. Material failure by HPA to comply with any of its material obligations contained herein, or material failure by Emergent to pay HPA amounts owed by Emergent to HPA hereunder, shall entitle the Party not in default to give to the Party in default notice specifying the nature of the default, requiring the defaulting Party to make good or otherwise cure such default, and stating its intention to terminate if such default is not cured. In the event that Emergent is the notifying Party, Emergent shall have the right, in addition to all other remedies available to it by law, in equity or pursuant to this Agreement, to suspend payment of any amounts that it would otherwise owe to HPA hereunder until such time as the material breach of HPA is cured (whereupon such suspended amounts shall be paid). If a noticed default is not cured within thirty (30) days (the “Cure Period”) after the receipt of such notice (or, if such default cannot be cured within such thirty (30)-day period, if the Party in default does not commence actions to cure such default within the Cure Period and

thereafter diligently continue such actions), the Party not in default shall be entitled, without prejudice to any of its other rights conferred on it by this Agreement, and in addition to any other remedies available to it by law or in equity, to terminate this Agreement in its entirety; provided, however, that any right to terminate under this Section 11.4 shall be stayed in the event that, during any Cure Period, the Party alleged to have been in default shall have initiated dispute resolution in accordance with Section 12.7 with respect to the alleged default, which stay shall last so long as the initiating Party diligently and in good faith cooperates in the prompt resolution of such dispute resolution proceedings.

     11.5 Termination of the BT License Agreement. In the event that the BT License Agreement is terminated in its entirety for any reason, this Agreement shall automatically terminate as of the same date.

     11.6 Accrued Rights; Survival; Return of Information.

          11.6.1 Accrued Rights. Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement.

          11.6.2 Survival. Sections 2.7, 2.9.3, 3.2, 3.3, 8.1, 8.2, 8.3, 8.4, 11.8, 12.2, 12.3, 12.5, 12.6, 12.7, 12.8, 12.9, 12.14, 12.16, 12.17 and this Section 11.6, and Articles IV, VI, VII, and X shall survive the termination or expiration of this Agreement for any reason. Sections 5.1 and 5.4 shall survive (a) the expiration of this Agreement and (b) the termination of this Agreement pursuant to Section 11.4, or pursuant to Section 11.5 (if such termination resulted from the termination of the BT License Agreement by Emergent for breach by HPA). Sections 5.1 and 5.4 shall not survive the termination of this Agreement for any other reason.

          11.6.3 Return of Information. Within ninety (90) days after the termination or expiration of this Agreement, each Party shall deliver to the other Party any and all data, files, and records in its possession or under its control that constitute the Confidential Information of such other Party (or, in the case of HPA as the delivering Party, that constitute Emergent Information), to which such Party does not retain rights hereunder (except that such Party shall have the right to retain one copy of each of the foregoing solely for archival purposes).

     11.7 Termination upon Insolvency. Either Party may terminate this Agreement if, at any time, the other Party shall file in any court or agency pursuant to any statute or regulation of any state, country or jurisdiction, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of that Party or of its assets, or if the other Party proposes a written agreement of composition or extension of its debts, or if the other Party shall be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed within sixty (60) days after the filing thereof, or if the other Party shall propose or be a party to any dissolution or liquidation, or if the other Party shall make an assignment for the benefit of its creditors.

     11.8 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by Emergent or HPA are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code, licenses of right to “intellectual property” as defined under Section 101 of the United States Bankruptcy Code. The Parties agree that the Parties, as licensees of such rights under this Agreement, shall retain and may fully exercise all of their rights and elections under the United States Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against either Party under the United States Bankruptcy Code, the Party hereto that is not a Party to such proceeding shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, which, if not already in the non-subject Party’s possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon the non-subject Party’s written request therefor, unless the Party subject to such proceeding elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under clause (a) above, following the rejection of this Agreement by or on behalf of the Party subject to such proceeding upon written request therefor by the non-subject Party.

ARTICLE XII
Miscellaneous

     12.1 Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement, when such failure or delay is caused by or results from causes beyond the reasonable control of the non-performing Party, including fires, floods, embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not), insurrections, riots, civil commotion, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any governmental authority. The non-performing Party shall notify the other Party of such force majeure within ten (10) days after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party shall use commercially reasonable efforts to remedy its inability to perform; provided, however, that in the event the suspension of performance continues for one-hundred and eighty (180) days after the date of the occurrence, the Parties shall meet and discuss in good faith how best to proceed.

     12.2 Export Control Regulations. The rights and obligations of the Parties under this Agreement shall be subject in all respects to United States laws and regulations and the analogous laws and regulations of England, as shall from time to time govern the license and delivery of technology and products between the United States and the United Kingdom, including the United States Foreign Assets Control Regulations, Transaction Control Regulations and Expert Control Regulations, as amended, and any successor legislation issued by the Department of Commerce, International Trade Administration, Office of Export Licensing. Without in any way limiting the provisions of this Agreement, each Party agrees that, unless prior authorization is obtained from the Office of Export Licensing, it shall not export, re-export, or transship, directly or indirectly, to any country, any of the technical data disclosed to it by the

other party if such export would violate the laws of the United States or the regulations of any department or agency of the United States Government.

     12.3 Assignment. Without the prior written consent of the other Party, neither Party shall sell, transfer, assign, delegate, charge, pledge or otherwise dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this Agreement or any of its rights or duties hereunder, nor purport to do any of the same; provided, however, that Emergent may, without such consent, assign the benefit of this Agreement and its rights hereunder to an Affiliate, to the purchaser of all or substantially all of its assets, or to any Third Party pursuant to or in connection with any agreement and plan of merger, acquisition, reorganization, or other similar corporate transaction; and provided, further, that HPA may, without such consent, assign the benefit of this Agreement and its rights hereunder to an Affiliate, or to a Third Party in connection with the permitted assignment to such Third Party of HPA’s rights under the BT License Agreement. Any attempted assignment in violation of the preceding sentence shall be void and of no effect. All validly assigned rights of the Parties hereunder shall be binding upon and inure to the benefit of and be enforceable by the permitted assigns of Emergent or HPA, as the case may be. No assignment validly made pursuant to this Section 12.3 shall relieve the assigning Party of any of its obligations under this Agreement, unless the other Party has given its prior consent thereto.

     12.4 Severability. If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future law, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom, and (d) the Parties agree to attempt to substitute for any such illegal, invalid or unenforceable provision a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Parties. To the fullest extent permitted by applicable law, each Party hereby waives any provision of law that would render any provision hereof prohibited or unenforceable in any respect.

     12.5 Notices. All notices or other communications which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (promptly confirmed by personal delivery or courier as provided herein) or sent by internationally-recognized overnight courier, addressed as follows:

		if to HPA, to:		Health Protection Agency
				Porton Down
				Salisbury, Wiltshire SP4 0JG England
				Attention: Dr. David Rhodes
				Facsimile No.: +44-1980-61-22-41
		with a copy to:		Legal Department
				Health Protection Agency
				Porton Down
				Salisbury, Wiltshire SP4 0JG England
				Facsimile No.: +44-1980-61-22-41

		if to Emergent, to:		Emergent BioSolutions, Inc.
				300 Professional Drive
				Gaithersburg, Maryland 20879 USA
				Attention: General Counsel
				Facsimile No.: +1-301-590-1252
		with a copy to:		Covington & Burling
				One Front Street, 35th Floor
				San Francisco, California 94111 USA
				Attention: James C. Snipes, Esq.
				Facsimile No.: +1-415-591-6091

          or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such communication shall be deemed to have been given when delivered if personally delivered on a Business Day, when transmitted if sent by facsimile (in accordance with this Section 12.5) on a Business Day, and on the third (3rd) Business Day after dispatch if sent by internationally-recognized courier. It is understood and agreed that this Section 12.5 is not intended to govern the day-to-day business communications necessary between the Parties in performing their duties, in due course, under the terms of this Agreement.

     12.6 Governing Law. This Agreement shall be governed by and construed in accordance with English law (without reference to the rules of conflict of laws thereof). Subject to Section 12.7, the Parties hereby irrevocably and unconditionally consent to the exclusive jurisdiction of (i) the courts of the State of New York and the United States District Court for the Southern District of New York for any action, suit or proceeding (other than appeals therefrom) initiated by HPA and arising out of or relating to this Agreement, and (ii) the English courts located in London for any action, suit or proceeding (other than appeals therefrom) initiated by Emergent and arising out of or relating to this Agreement. The Parties agree not to commence any action, suit or proceeding (other than appeals therefrom) related thereto except in such courts, respectively. The Parties further hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement in the courts of the State of New York or the United States District Court for the Southern District of New York, or the English courts located in London, as the case may be, and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum. Each Party hereto further agrees that service of any process, summons, notice or document by internationally recognized courier to its address set forth above shall be effective service of process for any action, suit or proceeding brought against it under this Agreement in any such court.

     12.7 Dispute Resolution.

          12.7.1 Negotiation. The Parties shall negotiate in good faith and use reasonable efforts to settle any dispute, controversy or claim arising from or related to this Agreement (or

any document or instrument delivered in connection herewith) (each, a “Dispute”). In the event that the Parties are unable to, within ten (10) days, to reach a resolution, such Dispute shall be referred to the chief executive officers of Emergent and HPA, or their respective successors, who shall attempt in good faith to reach a resolution of the Dispute. If the foregoing procedures fail to achieve a mutually satisfactory resolution within ten (10) days, then either Party may, by written notice to the other Party, elect to have the matter settled by binding arbitration pursuant to Section 12.7.2.

          12.7.2 Arbitration. Any arbitration under this Agreement shall take place at a location to be agreed by the Parties; provided, however, that in the event that the Parties are unable to agree on a location for an arbitration under this Agreement within five (5) days of the demand therefor, such arbitration shall be held in New York, New York if HPA is the Party that first demanded such arbitration or in London, England if Emergent is the Party that first demanded such arbitration. Any arbitration under this Agreement shall be administered by the American Arbitration Association under its Commercial Arbitration Rules then in effect (the “AAA Rules”). The Parties shall appoint an arbitrator by mutual agreement. If the Parties cannot agree on the appointment of an arbitrator within thirty (30) days of the demand for arbitration, an arbitrator shall be appointed in accordance with AAA Rules. The arbitrator shall have the authority to grant any equitable and legal remedies that would be available in any judicial proceeding instituted to resolve the Dispute submitted to such arbitration in accordance with this Agreement; provided, however, that the arbitrator shall not have the power to alter, amend or otherwise affect the terms or the provisions of this Agreement. Judgment upon any award rendered pursuant to this Section may be entered by any court having jurisdiction over the Parties other assets. The arbitrator shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damages. Each Party shall bear its own costs and expenses and attorneys’ fees and an equal share of the arbitrator’s fees and any administrative fees of arbitration, unless the arbitrator shall otherwise allocate such costs, expenses and fees between the Parties. The Parties agree that all arbitration awards shall be final and binding on the Parties and their Affiliates. The Parties hereby waive the right to contest the award in any court or other forum. Except to the extent necessary to confirm an award or as may be required by law, neither a Party nor an arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties. In no event shall an arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the dispute, controversy or claim would be barred by the applicable English statute of limitations.

          12.7.3 Interim Relief. Notwithstanding anything herein to the contrary, nothing in this Section 12.7 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute, either prior to or during any arbitration hereunder, if necessary to protect the interests of such Party. This Section 12.7.3 shall be specifically enforceable.

     12.8 Equitable Relief. HPA acknowledges and agrees that the restrictions set forth in Article VI of this Agreement are reasonable and necessary to protect the legitimate interests of Emergent and that Emergent would not have entered into this Agreement in the absence of such restrictions, and that any violation or threatened violation of any provision of Article VI will result in irreparable injury to Emergent. HPA also acknowledges and agrees that in the event of

a violation or threatened violation of any provision of Article VI, Emergent shall be entitled to preliminary and permanent injunctive relief, without the necessity of proving irreparable injury or actual damages and without the necessity of having to post a bond, as well as to an equitable accounting of all earnings, profits and other benefits arising from any such violation. The rights provided in the immediately preceding sentence shall be cumulative and in addition to any other rights or remedies that may be available to Emergent. Nothing in this Section 12.8 is intended, or should be construed, to limit Emergent’s right to preliminary and permanent injunctive relief or any other remedy for a breach of any other provision of this Agreement.

     12.9 No Benefit to Third Parties. Article II confers a benefit on those Persons referred to in Section 2.11 (the “Emergent Beneficiaries”) and, subject to the remaining provisions of this Section 12.9, is intended to be enforceable by the Emergent Beneficiaries by virtue of the Contracts (Rights of Third Parties) Act 1999 (the “Act”). The Parties do not intend that any provisions of this Agreement, apart from those of Article II, should be enforceable by virtue of the Act by any person who is not a party to this Agreement. Notwithstanding the provisions of this Section 12.9, this Agreement may be rescinded or amended in any way and at any time by the Parties in accordance with its terms, without the consent of any of the Emergent Beneficiaries.

     12.10 Further Assurances. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm the rights and remedies of the other Party under this Agreement.

     12.11 English Language. This Agreement shall be written and executed in the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control. All notices and other disclosure required of the parties hereunder shall be in English.

     12.12 References. Unless otherwise specified, (a) references in this Agreement to any Article, Section, Schedule or Exhibit shall mean references to such Article, Section, Schedule or Exhibit of this Agreement, (b) references in any section to any clause are references to such clause of such section, and (c) references to any agreement, instrument or other document in this Agreement refer to such agreement, instrument or other document as originally executed or, if subsequently varied, replaced or supplemented from time to time, as so varied, replaced or supplemented and in effect at the relevant time of reference thereto.

     12.13 Independent Contractors. It is expressly agreed that HPA and Emergent shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture or agency. Neither HPA nor Emergent shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other, without the prior consent of the other Party. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and

obligations incurred by reason of any such employment shall be for the account and expense of such Party.

     12.14 Waiver. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party of any right hereunder, or the failure to exercise, or delay in exercising a right or remedy provided by this Agreement or by law, or the waiver of a breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise.

     12.15 Counterparts. The Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

     12.16 Construction. Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word “or” is used in the inclusive sense. The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term “including” as used herein shall mean including, without limiting the generality of any description preceding such term. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties, and no rule of strict construction shall be applied against either Party.

     12.17 Entire Agreement; Modifications. This Agreement, together with the BT License Agreement, the rBOT Development Agreement, the rBOT License Agreement, and the Distribution Agreement, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understanding, promises and representations, whether written or oral, with respect thereto are superseded hereby. Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth herein. No amendment, modification, release or discharge hereof shall be binding upon the parties unless in writing and duly executed by authorized representatives of both Parties.

[SIGNATURE PAGE FOLLOWS.]

     IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first set forth above.

Emergent BioSolutions, Inc.						Health Protection Agency
By:		/s/ Fuad El-Hibri				By:		/s/ Pat Troop
		Fuad El-Hibri						Pat Troop
Title:		Chairman and CEO				Title:		CEO

Schedule 1.19

Development Plan

A framework for the proposed development plan to produce a botulinum tetravalent (A,B, C & E) vaccine is given below. The framework consists of a number of work packages the scope of which are provided as outlines. It is intended that each work programme will be presented as a detailed, fully-costed proposal for written approval by Emergent BioSolutions prior to commencement. Whilst an attempt has been made to cover all work packages currently envisaged, further work may arise during the development programme and may be agreed between HPA and Emergent at a later date.

Process/Analytical Development

[**]

Process Confirmation

[**]

GMP Manufacture

[**]

Schedule 2.3

Key Personnel

HPA operates a project management system and will nominate a project management team for this project. The lead will be taken by a General Project Manager who will provide the chief contact between HPA and Emergent BioSolutions. The following HPA staff have previous experience in the manufacture and testing of botulinum toxins and as such will provide form part of the project team or provide input into this project.

Confirmation of such key staff and their time allocation tot he various work packages will be provided as part of the detailed HPA proposals for agreement by Emergent prior to commencing work.

Process Development

[**]

GMP Manufacture

[**]

Project Management

[**]

Schedule 3.1

Development Budget

The following budget figures are provided for indicative purposes only and should not be regarded as firm or complete. Firm prices will be prepared for each work package requested under the development programme.

Process/Analytical Development

$[**]

Process confirmation

$[**]

GMP Manufacture/Stability Studies

$[**]