Research and License Agreement - OraVax Merieux Co., Merieux OraVax SNC, and MedImmune Inc.
RESEARCH AND LICENSE AGREEMENT This Agreement, effective as of November 1, 1996 ("EFFECTIVE DATE"), by and between OraVax Merieux Co. ("O-M") having an address at 38 Sidney Street, Cambridge, MA 02139, Merieux OraVax S.N.C. ("M-O") having an address at 58. avenue Leclerc, 69007 Lyon, France ("O-M" and "M-O" are individually and collectively referred to as "HPC") and MedImmune, Inc., a Delaware Corporation having offices at 35 West Watkins Mill Road, Gaithersburg, MD 20878 ("MEDIMMUNE") and Human Genome Sciences, Inc., a Delaware corporation having offices at 9410 Key West Avenue, Rockville, MD 20850 ("HGS"). WHEREAS, HPC, MEDIMMUNE and HGS each have substantial knowledge and expertise in and own or have rights to certain technology relating to vaccines, genes, gene sequencing, protein expression and purification; and WHEREAS, the PARTIES desire to enter into a research and licensing arrangement in an effort to develop vaccines against Helicobacter pylori ("H. pylori"). NOW THEREFORE, in consideration of the mutual promises and other good and valuable consideration, the PARTIES agree as follows: SECTION 1 - DEFINITIONS. The terms used in this Agreement have the following meaning: 1.1 "AFFILIATE" shall mean, with respect to any person or entity, (i) any other person or entity of which the securities or other ownership interests representing fifty per cent (50%) or more of the equity or fifty percent (50%) or more of the ordinary voting power or fifty percent (50%) or more of the general partnership interest are, at the time such determination is being made, owned, Controlled or held, directly or indirectly, by such person or entity, or (ii) any other person or entity which, at the time such determination is being made, is Controlling, Controlled by or under common Control with, such person or entity. As used herein, the term "Control" whether used as a noun or verb, refers to the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of a person or entity whether through the ownership of voting securities, by contract or otherwise. 1.2 "CONFIDENTIAL INFORMATION" shall mean know-how, technology, inventions, technical information, software, data, biological materials and the like which are owned or controlled by the disclosing PARTY or which that PARTY is obligated to maintain in confidence, provided, however, that information disclosed by Dr. J.F. Tomb during a presentation at the "9th International Workshop on Gastroduodenal Pathology and Helicobacter pylori" held October 16-19, 1996 in Copenhagen (the "TOMB DISCLOSURE") will be excluded from the definition of CONFIDENTIAL INFORMATION. 1.3 "FIELD" means the treatment or prevention of infection or disease caused by H. pylori by use of a VACCINE. 1.4 "GENE" means DNA (or a portion thereof) of H. pylori. 1.5 "HGS" shall mean Human Genome Sciences, Inc. 1.6 "JOINT INVENTIONS" shall mean inventions conceived and reduced to practice during the term of this Agreement jointly by employees or others acting on behalf of HPC or its AFFILIATES and by employees or others acting on behalf of MEDIMMUNE or HGS, as the case may be, or their AFFILIATES. 1.7 "JOINT PATENTS" shall mean (a) all patent applications hereafter filed or having legal force in any country owned jointly by MEDIMMUNE or HGS as the case may be and HPC, which claim a composition, method or process relating to a JOINT INVENTION, together with any and all patents that have issued or in the future issue therefrom, and (b) all related divisionals, continuations, continuations-in-part, reissues, renewals or extensions or foreign counterparts to any such patents and patent applications. 1.8 "HGS PATENTS" shall mean all patents and patent applications which claim HGS TECHNOLOGY owned by HGS or which has been licensed to HGS or JOINT PATENTS in which HGS has an ownership interest. Included within the definition of HGS PATENTS are all continuations, continuations-in-part, divisions, reissues, renewals, extensions or foreign counterparts thereof. 1.9 "HGS TECHNOLOGY" shall mean (i) GENES and/or expression products thereof (including sequence and function) and (ii) biological and genomic information with respect to GENES in each case which have been developed by or on behalf of HGS prior to or within one year after the EFFECTIVE DATE and which is owned by HGS in whole or in part, provided, however, that for the purposes of determining the royalty due under Section 3.2(b) hereof, HGS TECHNOLOGY shall not include such GENES, expression products, or biological and genomic information with respect to such GENES that were developed by or otherwise known to HPC prior to the EFFECTIVE DATE. 1.10 "LICENSED PATENTS" means MEDIMMUNE PATENT(S) and/or HGS PATENT(S) and/or JOINT PATENTS. 1.11 "LICENSED TECHNOLOGY" means MEDIMMUNE TECHNOLOGY and/or HGS TECHNOLOGY and/or JOINT INVENTIONS. 1.12 "LICENSED TERRITORY" means all countries of the world. 1.13 "MEDIMMUNE PATENT(S)" shall mean all patents and patent applications which claim MEDIMMUNE TECHNOLOGY owned by MEDIMMUNE or which MEDIMMUNE has licensed from HGS or JOINT PATENTS in which MEDIMMUNE has an ownership interest. Included within the definition of MEDIMMUNE PATENTS are all continuations, continuations-in-part, divisions, reissues, renewals, extensions or foreign counterparts thereof. 1.14 "MEDIMMUNE TECHNOLOGY" shall mean (i) GENES and/or expression products thereof (including sequence and function) and (ii) biological and genomic information with respect to GENES in each case which has been developed by or on behalf of MEDIMMUNE prior to or within one year after the EFFECTIVE DATE and which is owned by MEDIMMUNE in whole or in part and/or which have been licensed by MEDIMMUNE from HGS, provided, however, that for the purposes of determining the royalty due under Section 3.2(b) hereof, MEDIMMUNE TECHNOLOGY shall not include such GENES, expression products, or biological and genomic information with respect to such GENES that were developed by or otherwise known to HPC prior to the EFFECTIVE DATE. 1.15 "NET SALES PRICE" means the total amount invoiced by HPC, its AFFILIATES or its licensees for sale of PRODUCT, less transportation charges and insurance, sales taxes, use taxes, excise taxes, value added taxes, customs duties or other imposts, in each case as separately invoiced, normal and customary quantity and cash discounts, rebates granted and disallowed reimbursements and allowances and credit on account of rejection or return of PRODUCT. In the event a sale is made between HPC and an AFFILIATE(S) for re-sale then NET SALES PRICE for determining a payment under this Agreement shall be the higher of (i) net sales to the AFFILIATES calculated in the manner of NET SALES PRICE, or (ii) the NET SALES PRICE of the AFFILIATE(S) to an independent third party. 1.16 "PARTY" shall mean O-M, M-O, MEDIMMUNE or HGS. 1.17 "PATENT(S)" means individually and collectively MEDIMMUNE PATENTS, HPC PATENTS, HGS PATENTS and JOINT PATENTS. 1.18 "HPC PATENT(S)" shall mean all patents and patent applications which claim HPC TECHNOLOGY owned by HPC or JOINT PATENTS in which HPC has an ownership interest. Included within the definition of HPC PATENTS are all continuations, continuations-in-part, divisions, reissues, renewals, extensions or foreign counterparts thereof. 1.19 "HPC TECHNOLOGY" means GENES and/or expression products thereof (including sequence and function), any process, use, article of manufacture, composition of matter, information (including biological and genomic information with respect to GENES), data and materials, whether patentable or not, which incorporates or is based on or uses or is derived by use of LICENSED TECHNOLOGY and which is developed by or on behalf of HPC or any of their collaborators or licensees during the term of this Agreement, provided, however, that for the purposes of determining the royalty due under Section 3.2(b) hereof, HPC TECHNOLOGY shall not include any GENE, expression product, process, use, article of manufacture, composition of matter, information, data or materials that were developed by or otherwise known to HPC prior to the EFFECTIVE DATE. 1.20 "PRODUCT(S)" shall mean any product, process, method, substance, device, composition, or service which (i) incorporates or is based on or uses or is derived by use of LICENSED TECHNOLOGY and/or HPC TECHNOLOGY and/or (ii) is covered by a LICENSED PATENT and/or (iii) is covered by a HPC PATENT. An incidental or insubstantial use of LICENSED TECHNOLOGY or HPC TECHNOLOGY shall not cause a product, process, method, substance, device, composition or service to become a PRODUCT. 1.21 "VACCINE" means a substance(s) utilized for active immunization against infectious agents. 1.22 "VALID CLAIM" means (i) a claim of a pending patent application or, (ii) a claim of an issued patent which has not lapsed or become abandoned or been declared invalid or unenforceable by a court of competent jurisdiction or an administrative agency from which no appeal can be or is taken. SECTION 2 - GRANTS AND COVENANTS 2.1 Subject to the terms and conditions of this Agreement, MEDIMMUNE grants to HPC an exclusive, worldwide royalty free (except for the license fee payments set forth in Section 3.1) license under MEDIMMUNE TECHNOLOGY, MEDIMMUNE PATENTS and MEDIMMUNE'S ownership interest in JOINT INVENTIONS and JOINT PATENTS to perform research and development of PRODUCTS for use in the FIELD. HPC shall have the right to grant sublicenses only as provided in Paragraph 2.6. 2.2 Subject to the terms and conditions of this Agreement, MEDIMMUNE grants to HPC an exclusive, sublicensable, worldwide royalty-bearing license in the FIELD under MEDIMMUNE TECHNOLOGY, MEDIMMUNE PATENTS and MEDIMMUNE'S ownership interest in JOINT INVENTIONS and JOINT PATENTS to make, have made, use, sell, import and export PRODUCTS in the FIELD. HPC shall have the right to grant sublicenses only as provided in Paragraph 2.6. 2.3 Subject to the terms and conditions of this Agreement, HGS grants to HPC an exclusive, worldwide, royalty free (except for the license fee payments set forth in Section 3.1) license under HGS TECHNOLOGY, HGS PATENTS and HGS' ownership interest in JOINT INVENTIONS and JOINT PATENTS, to perform research and development of PRODUCTS for use in the FIELD. HPC shall have the right to grant sublicenses only as provided in Paragraph 2.6. 2.4 Subject to the terms and conditions of this Agreement, HGS grants to HPC an exclusive, sublicensable, worldwide royalty-bearing license in the FIELD under HGS TECHNOLOGY, HGS PATENTS and HGS' ownership interest in JOINT INVENTIONS and JOINT PATENTS to make, have made, use, sell, import and export PRODUCTS in the FIELD. HPC shall have the right to grant sublicenses only as provided in Paragraph 2.6 2.5 (a) During the term of this Agreement, HPC agrees to use and to grant rights to HPC TECHNOLOGY and HPC PATENTS, in each case and with respect to HPC'S interest in JOINT INVENTIONS and JOINT PATENTS only in the FIELD or only as otherwise permitted by this Agreement. (b) During the term of this Agreement, HGS agrees to use and to grant rights to HGS TECHNOLOGY and HGS PATENTS, in each case and with respect to HGS' interest in JOINT INVENTIONS and JOINT PATENTS, only outside the FIELD and only as permitted by this Agreement. (c) During the term of this Agreement, MEDIMMUNE agrees to use and to grant rights to MEDIMMUNE TECHNOLOGY and MEDIMMUNE PATENTS, in each case and with respect to MEDIMMUNE'S interest in JOINT INVENTIONS and JOINT PATENTS, only outside the FIELD and only as permitted by this Agreement. (d) During and after the term of this Agreement, HPC agrees to use MEDIMMUNE TECHNOLOGY and MEDIMMUNE PATENTS and HGS TECHNOLOGY and HGS PATENTS and JOINT INVENTIONS and JOINT PATENTS only as licensed and permitted hereunder. (e) Except as set forth in Section 9.1(b) of this Agreement, neither PARTY will use, license or sublicense their respective interest in the JOINT INVENTIONS or JOINT PATENTS outside the FIELD without the express written consent of the other PARTY having an interest in such JOINT INVENTION or JOINT PATENT. 2.6 The rights and licenses granted to HPC by MEDIMMUNE and HGS under this Agreement, and rights to HPC TECHNOLOGY and HPC PATENTS, JOINT INVENTIONS and JOINT PATENTS are licensable and/or transferable by HPC to a third party only with respect to a PRODUCT in the FIELD, and, except for any implied sublicense attaching to the commercial sale or distribution of the PRODUCTS, pursuant to an agreement in which the third party(ies) agree(s) (i) to covenants and obligations which limit the use of PRODUCTS, MEDIMMUNE TECHNOLOGY, MEDIMMUNE PATENTS, HGS TECHNOLOGY, HGS PATENTS, JOINT INVENTIONS, JOINT PATENTS, HPC TECHNOLOGY and HPC PATENTS which are essentially identical to the covenants and obligations of HPC to MEDIMMUNE and HGS under this Agreement and (ii) to obligations identical to Sections 5, 6 and 8 of this Agreement. Upon termination of this Agreement for any reason, any sublicense granted by HPC hereunder not then in default shall remain in force and effect in accordance with its terms, provided, however, that any sublicenses granted by HPC under this Agreement shall provide for termination or assignment to MEDIMMUNE and/or HGS, as the case may be, upon termination of this Agreement. 2.7 HPC shall be solely responsible for the licensing, manufacturing, marketing and sale of all PRODUCTS in the FIELD. SECTION 3 - PAYMENTS 3.1 In partial consideration of the rights granted to HPC hereunder, HPC shall pay to MEDIMMUNE as a license fee of up to (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) U.S. dollars ($U.S. (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)) which shall be due and payable in three payments as follows: (i) a payment of $(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) which is due and payable on or before December 6, 1996; (ii) a second payment of $(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) which is due and payable five (5) months after the EFFECTIVE DATE (the "SECOND PAYMENT DATE"), provided, however, that such second payment of $(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) shall be pro-rated at a rate of $(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) per month for each month, or part thereof, prior to the SECOND PAYMENT DATE that any of the HGS TECHNOLOGY or MEDIMMUNE TECHNOLOGY no longer qualifies as CONFIDENTIAL INFORMATION due to disclosure of such HGS TECHNOLOGY or MEDIMMUNE TECHNOLOGY by HGS, MEDIMMUNE or TIGR, with it being expressly understood that the TOMB DISCLOSURE is not a disclosure of such HGS TECHNOLOGY or MEDIMMUNE TECHNOLOGY; and (iii) a final payment of $(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) which is due and payable upon the issuance of the first United States, Japanese or European Union country PATENT. All payments to be made hereunder are payable within 10 days of its due date and shall be by wire transfer or other commercially reasonable method of transfer of immediately available funds to an account designated by MEDIMMUNE. 3.2 HPC shall pay to MEDIMMUNE a royalty on the NET SALES PRICE of PRODUCTS sold by HPC, its AFFILIATES or its licensees as follows: (a)For PRODUCTS covered by a VALID CLAIM of the PATENTS where manufactured, used or sold, the royalty shall be (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)% of NET SALES PRICE. No royalty shall be due under this Section 3.2(a) on any PRODUCTS covered only by a VALID CLAIM of a pending PATENT which has not issued seven (7) years following its earliest priority date (the "CUT-OFF DATE"), provided, however, that royalties shall continue to accrue for up to three (3) years after the CUT-OFF DATE while such PATENT remains pending, and such accrued royalty shall become payable only upon the issuance of such pending PATENT within such 3-year period. (b)For PRODUCTS which are not covered by a VALID CLAIM of PATENTS where manufactured, used or sold, the royalty shall be (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)% of NET SALES PRICE. 3.3 HPC shall make the following milestone payments to MEDIMMUNE for PRODUCTS, which milestone payment shall be due and payable within thirty (30) days after the milestone event is achieved by or on behalf of HPC or an AFFILIATE of HPC or a licensee of HPC: (i) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)U.S. Dollars ($(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)) upon the first filing of a Product License Application in the United States or equivalent outside the United States for the first PRODUCT; (ii) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)U.S. Dollars ($(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)) when cumulative NET SALES PRICE of PRODUCT(S) sold by HPC and/or its AFFILIATES and/or licensees exceed (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) U.S. Dollars ($(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)); and (iii) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)U.S. Dollars ($(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)) when cumulative NET SALES PRICE of PRODUCT(S) sold by HPC and/or its AFFILIATES and/or licensees exceed (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) U.S. Dollars ($(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)). The milestone payments provided in this Section 3.3 shall only be made once and shall not be creditable or refundable. 3.4 Royalty obligations under this Agreement and any agreements that HPC shall enter into with a licensee with respect to PRODUCT shall terminate on a country-by-country and PRODUCT- by-PRODUCT basis on the later of (i) ten (10) years after first country-wide launch of the first PRODUCT in each country or (ii) expiration of the last to expire PATENT which covers the making, having made, importing, exporting, offering to sell or using or selling of each PRODUCT in each country. 3.5 All payments to be made hereunder shall be in United States Dollars and by wire transfer, or other commercially reasonable method of transfer, of immediately available funds to an account designated by MEDIMMUNE. 3.6 No multiple royalties shall be payable because any PRODUCT, or its manufacture or sale are or shall be covered by more than one PATENT licensed under this Agreement. SECTION 4 - TRANSFER OF LICENSED TECHNOLOGY 4.1 MEDIMMUNE and HGS, as the case may be, shall promptly transfer the LICENSED TECHNOLOGY described in Exhibit A, attached hereto and made a part hereof which is CONFIDENTIAL INFORMATION to HPC. 4.2 During the first year of this Agreement MEDIMMUNE or HGS as the case may be, at HPC's reasonable request and expense shall provide to HPC reasonable technical assistance with respect to LICENSED TECHNOLOGY in order to assure that HPC is able to access and use the LICENSED TECHNOLOGY transferred under Section 4.1. 4.3 HPC agrees to maintain security measures for LICENSED TECHNOLOGY which are similar to the measures currently employed by HPC to safeguard its own CONFIDENTIAL INFORMATION. 4.4 For the purpose of facilitating an understanding of the research activities in the FIELD conducted by each party hereunder, the PARTIES will permit duly authorized employees or representatives of the other to visit its facilities where the research is conducted, at reasonable times and with reasonable notice. 4.5 The transfer of one PARTY's materials to the other PARTY pursuant to this Section shall not be considered to transfer title to the materials or their progeny, but shall be considered a bailment for the benefit of both PARTIES. SECTION 5 - CONFIDENTIALITY. 5.1 During the term of this Agreement, it is contemplated that each PARTY will disclose to the other CONFIDENTIAL INFORMATION. Each PARTY agrees to retain the other party's CONFIDENTIAL INFORMATION in confidence and not to disclose any such CONFIDENTIAL INFORMATION to a third PARTY without the prior written consent of the disclosing PARTY and to use the other PARTY's CONFIDENTIAL INFORMATION only for the purposes of this Agreement. In addition to the obligations of confidentiality set forth above in this Section 5.1, HPC and MEDIMMUNE each agree (i) not to publish LICENSED TECHNOLOGY or HPC TECHNOLOGY which is CONFIDENTIAL INFORMATION prior to a publication of HGS TECHNOLOGY by TIGR, and (ii) that investigators from TIGR shall be included as co-authors of such publications by HPC or MEDIMMUNE if reasonably warranted. 5.2 The obligations of confidentiality of Section 5.1 and the definition of CONFIDENTIAL INFORMATION will not apply to data, information and materials that: (a)was known to the receiving PARTY or generally known to the public prior to its disclosure hereunder; or (b)subsequently becomes known to the public by some means other than a breach of this Agreement, or, with respect to HGS TECHNOLOGY and MEDIMMUNE TECHNOLOGY, subsequently becomes known to the public by disclosure or publication by HGS, MEDIMMUNE or The Institute for Genomic Research ("TIGR"); (c)is subsequently disclosed to the receiving PARTY by a third party having a lawful right to make such disclosure; (d)is required by law or bona fide legal process to be disclosed, provided that the PARTY required to make the disclosure takes all reasonable steps to restrict and maintain confidentiality of such disclosure and provides reasonable notice to the PARTY providing the disclosure; or (e)is approved for release by the PARTIES, or (f)is independently developed by the employees or agents of either PARTY without any knowledge of the CONFIDENTIAL INFORMATION provided by the other PARTY. 5.3 Notwithstanding Paragraph 5.1, HPC may disclose and/or provide LICENSED TECHNOLOGY to a third party who (i) receives a license from HPC to LICENSED TECHNOLOGY in conjunction with a license to a PRODUCT in the FIELD as permitted under this Agreement, or (ii) is a third party contractor assisting HPC with respect to research and development of a PRODUCT in the FIELD, provided that such third party agrees to confidentiality and non-use obligations essentially identical to Paragraph 5.1, and further provided that such third party agrees to be bound by the obligations of Paragraph 2.6. It is expressly understood that inventions and developments of any such third party shall be HPC TECHNOLOGY to the extent that they fall within the definition thereof. 5.4 All CONFIDENTIAL INFORMATION disclosed by one PARTY to another PARTY shall remain the intellectual property of the disclosing PARTY. In the event that a court or other legal or administrative tribunal, directly or through an appointed master, trustee or receiver, assumes partial or complete control over the assets of a PARTY to this Agreement based on the insolvency or bankruptcy of such PARTY, the bankrupt or insolvent PARTY shall promptly notify the court or other tribunal (i) that CONFIDENTIAL INFORMATION received from another PARTY under this Agreement remains the property of the other PARTY and (ii) of the confidentiality obligations under this Agreement. In addition, the bankrupt or insolvent PARTY shall, to the extent permitted by law, take all steps necessary or desirable to maintain the confidentiality of the other PARTY's CONFIDENTIAL INFORMATION and to insure that the court, other tribunal or appointee maintains such information in confidence in accordance with the terms of this Agreement. 5.5 Neither HPC, MEDIMMUNE nor HGS shall, without the prior written consent of the others, issue any press release or make any other public announcement or furnish any statement to any person (other than either PARTIES' respective AFFILIATES) concerning the existence of this Agreement and the transactions contemplated by this Agreement, except for (i) disclosures made in compliance with Sections 5.1, 5.2 and 5.3, hereof, (ii) attorneys, consultants, and accountants retained to represent them in connection with the transactions contemplated hereby and (iii) occasional, brief comments by the respective officers of HPC, MEDIMMUNE and HGS consistent with such guidelines for public statements as may be mutually agreed by HPC, MEDIMMUNE and HGS made in connection with routine interviews with analysts or members of the financial press. In addition, each PARTY (after consultation with counsel) in its own right may make such further announcements and disclosures, if any, as may be required by applicable law, rule or regulation in which case the PARTY making the announcement or disclosure shall use its best efforts to give advance notice to, and discuss such announcement or disclosure with, the other PARTIES. SECTION 6 - ROYALTY PAYMENTS AND RECORDS 6.1 HPC shall keep, and shall cause each of its AFFILIATES and licensees to keep, full and accurate books of account containing all particulars that may be necessary for the purpose of calculating all royalties payable to MEDIMMUNE. Such books of account shall be kept at their principal place of business and, with all necessary supporting data shall, for the three (3) years next following the end of the calendar year to which each shall pertain be open for inspection by an independent certified accountant reasonably acceptable to HPC upon reasonable notice during normal business hours at MEDIMMUNE' expense for the sole purpose of verifying royalty statements or compliance with this Agreement, but in no event more than once in each calendar year. All information and data offered shall be used only for the purpose of verifying royalties and shall be treated as HPC CONFIDENTIAL INFORMATION subject to the obligations of this Agreement. In the event that such inspection shall indicate that in any calendar year that the royalties which should have been paid by HPC are at least (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) percent ((CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)%) greater than those which were actually paid to MEDIMMUNE, then HPC shall pay the cost of such inspection and shall immediately pay any royalty deficiency. 6.2 In each year the amount of royalty due shall be calculated quarterly as of March 31, June 30, September 30 and December 31 (each as being the last day of an "ACCOUNTING PERIOD") and shall be paid quarterly within the following sixty days, every such payment shall be supported by the accounting prescribed herein and shall be made in United States dollars. For the purpose of calculating royalties conversion from any foreign currency, such conversion shall be at the Exchange Rate published in the Wall Street Journal under "Currency Trading," for the last business day of the applicable ACCOUNTING PERIOD. 6.3 With each quarterly payment, HPC shall deliver to MEDIMMUNE a full and accurate accounting to include at least the following information on a country-by-country basis: (a)Quantity of each PRODUCT subject to royalty sold (by country) by HPC, its AFFILIATES and licensees. (b)Total invoice and receipts for each PRODUCT subject to royalty (by country); (c)Calculation of NET SALES PRICE; (d)Any other information reasonably requested by MEDIMMUNE to permit MEDIMMUNE to determine royalties owed; (e)Total royalties payable to MEDIMMUNE. 6.4 Any tax required to be withheld by HPC under the laws of any foreign country for the account of MEDIMMUNE shall be promptly paid by HPC for and on behalf of MEDIMMUNE to the appropriate governmental authority, and HPC shall furnish MEDIMMUNE with proof of payment of such tax. Any such tax actually paid on MEDIMMUNE's behalf shall be deducted from royalty payments due MEDIMMUNE. SECTION 7 - REPRESENTATIONS AND WARRANTIES. 7.1 MEDIMMUNE represents and warrants that: (a)the execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized by all appropriate MEDIMMUNE corporate action; (b)the performance by MEDIMMUNE of any of the terms and conditions of this Agreement on its part to be performed does not and will not constitute a breach or violation of any other agreement or understanding, written or oral, to which it is a PARTY; (c)it has the full right and legal capacity to provide the rights to the MEDIMMUNE PATENTS and MEDIMMUNE TECHNOLOGY granted to HPC hereunder, and the rights to provide rights to information and access granted under Section 2; (d)there are no outstanding agreements, assignments and encumbrances to which MEDIMMUNE is a PARTY inconsistent with the provisions of this Agreement; (e)there are no adverse proceedings, claims or actions pending, or to the best knowledge of MEDIMMUNE, threatened, relating to the MEDIMMUNE PATENTS or MEDIMMUNE TECHNOLOGY, and at the time of disclosure and delivery thereof to HPC, to the best knowledge of MEDIMMUNE it shall have the full right and legal capacity to disclose and deliver the MEDIMMUNE PATENTS or MEDIMMUNE TECHNOLOGY without violating the rights of third parties. (f)as of the EFFECTIVE DATE it has maintained the MEDIMMUNE TECHNOLOGY as CONFIDENTIAL INFORMATION consistent with the provisions of Section 5 hereof, it will continue to maintain the MEDIMMUNE TECHNOLOGY as CONFIDENTIAL INFORMATION until publication as provided for herein, as of the EFFECTIVE DATE it has not submitted any of the MEDIMMUNE TECHNOLOGY for publication, and it will not publish any of the MEDIMMUNE TECHNOLOGY prior to five months from the EFFECTIVE DATE. 7.2 HPC represents and warrants that: (a)the execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized by all appropriate HPC corporate action; (b)the performance by HPC of any of the terms and conditions of this Agreement on its part to be performed does not and will not constitute a breach or violation of any other agreement or understanding, written or oral, to which it is a party; (c)it has the full right and legal capacity to provide the rights to the HPC PATENTS and HPC TECHNOLOGY granted to MEDIMMUNE hereunder; (d)there are no outstanding agreements, assignments and encumbrances to which HPC is a PARTY inconsistent with the provisions of this Agreement; and (e)there are no adverse proceedings, claims or actions pending, or to the best knowledge of HPC, threatened, relating to the HPC PATENTS or HPC TECHNOLOGY, and at the time of disclosure and delivery thereof to MEDIMMUNE, to the best knowledge of HPC it shall have the full right and legal capacity to disclose and deliver the HPC PATENTS or HPC TECHNOLOGY without violating the rights of third parties. 7.3 HGS represents and warrants that: (a)the execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized by all appropriate HGS corporate action; (b)the performance by HGS of any of the terms and conditions of this Agreement on its party to be performed does not and will not constitute a breach or violation of any other agreement or understanding, written or oral, to which it is a PARTY: (c)HGS has provided MEDIMMUNE with the full right and legal capacity under HGS intellectual property rights necessary for MEDIMMUNE to provide the rights to the MEDIMMUNE PATENTS and MEDIMMUNE TECHNOLOGY granted to HPC hereunder; (d)there are no outstanding agreements, assignments and encumbrances to which HGS is a party inconsistent with the provisions of this Agreement; (e)there are no adverse proceedings, claims or actions pending, or to the best knowledge of HGS, threatened, relating to HGS' intellectual property interests in the MEDIMMUNE PATENTS or MEDIMMUNE TECHNOLOGY, and at the time of disclosure and delivery thereof to HPC, to the best knowledge of HGS it shall have the full right and legal capacity to disclose and deliver the HGS intellectual property interests in the MEDIMMUNE PATENTS or MEDIMMUNE TECHNOLOGY without violating the rights of third parties. (f)as of the EFFECTIVE DATE it has maintained the HGS TECHNOLOGY as CONFIDENTIAL INFORMATION consistent with the provisions of Section 5 hereof, it will continue to maintain the HGS TECHNOLOGY as CONFIDENTIAL INFORMATION until publication as provided for herein, as of the EFFECTIVE DATE it has not submitted any of the HGS TECHNOLOGY for publication, and it will not publish any of the HGS TECHNOLOGY prior to five months from the EFFECTIVE DATE. 7.4 EXCEPT AS OTHERWISE EXPRESSLY PROVIDED FOR IN THIS AGREEMENT, NO PARTY TO THIS AGREEMENT MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OR VALIDITY OF ANY INTELLECTUAL PROPERTY RIGHTS. SECTION 8 - INDEMNIFICATION. 8.1 HPC shall defend, indemnify and hold harmless MEDIMMUNE, HGS, licensors of MEDIMMUNE and HGS and each of their respective directors, officers, shareholders, agents and employees (each an "Indemnitee"), from and against any and all liability, loss, damages and expenses (including reasonable attorneys' fees) as the result of claims, demands, costs or judgments which may be made or instituted against any of them arising out of the manufacture, possession, distribution, use, testing, sale or other disposition of any PRODUCT by or through or on behalf of HPC or any third party granted rights by HPC under this Agreement or any third party that obtains PRODUCT from HPC. HPC's obligation to defend, indemnify and hold harmless shall include claims, demands, costs or judgments, whether for money damages or equitable relief by reason of alleged personal injury (including death) to any person or alleged property damage, provided, however, the indemnity shall not extend to any claims against an indemnified party which result from the gross negligence or willful misconduct of such indemnified party. The provisions of this paragraph shall survive and remain in full force and effect after any termination, expiration or cancellation of this Agreement and the obligation hereunder shall apply whether or not such claims are rightfully brought. 8.2 To the extent that HPC grants a license to MEDIMMUNE and/or HGS pursuant to Section 9.1(b) hereof, then MEDIMMUNE and/or HGS, as the case may be, (the "Indemnitor(s)") shall defend, indemnify and hold harmless HPC, licensors of HPC and each of their respective directors, officers, shareholders, agents and employees (each an "Indemnitee"), from and against any and all liability, loss, damages and expenses (including reasonable attorneys' fees) as the result of claims, demands, costs or judgments which may be made or instituted against any of them arising out of the manufacture, possession, distribution, use, testing, sale or other disposition of any PRODUCT outside the FIELD by or through or on behalf of the Indemnitor(s) or any third party granted rights by the Indemnitor(s) or any third party that obtains such PRODUCT from the Indemnitor(s). The Indemnitor(s)' obligation to defend, indemnify and hold harmless shall include claims, demands, costs or judgments, whether for money damages or equitable relief by reason of alleged personal injury (including death) to any person or alleged property damage, provided, however, the indemnity shall not extend to any claims against an indemnified party which result from the gross negligence or willful misconduct of such indemnified party. The provisions of this paragraph shall survive and remain in full force and effect after any termination, expiration or cancellation of this Agreement and the obligation hereunder shall apply whether or not such claims are rightfully brought. 8.3 An Indemnitee shall promptly notify the Indemnitor(s) of any loss, claim, damage, liability, or action in respect of which the Indemnitee intends to claim such indemnification, and the Indemnitor, shall assume the defense thereof; provided, however, that an Indemnitee shall have the right to retain its own counsel, with the fees and expenses to be paid by the Indemnitor if Indemnitor does not assume the defense; or, if representation of such Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between such Indemnitee and any other party represented by such counsel in such proceedings. The indemnity agreement in this Section 8 shall not apply to amounts paid in settlement of any loss, claim, damage, liability or action if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld unreasonably. The failure to deliver notice to the Indemnitor within a reasonable time after the commencement of any such action, if prejudicial to its ability to defend such action, shall relieve such Indemnitor of any liability to the Indemnitee under this Section 8, but the omission so to deliver notice to the Indemnitor will not relieve it of any liability that it may have to any Indemnitee otherwise than under this Section 8. The Indemnitee under this Section 8, its employees and agents, shall cooperate fully with the Indemnitor and its legal representatives in the investigations of any action, claim or liability covered by this indemnification. SECTION 9 - PATENTS 9.1 (a) Each party shall have and retain sole and exclusive title to all inventions, discoveries, designs, works of authorship and other know-how which are made, conceived, reduced to practice or generated by its employees, agents, or other persons acting under its authority. As to all inventions, discoveries, designs, works of authorship and other know-how made, conceived, reduced to practice or generated jointly by employees, agents, or other persons acting under the authority of MEDIMMUNE and/or HGS and HPC, the parties shall own an equal undivided interest therein. HPC shall be responsible for the filing, prosecution and maintenance of HPC PATENTS and LICENSED PATENTS including JOINT PATENTS which do not have significant commercial utility outside the FIELD, but excluding (i) JOINT PATENTS which do have significant commercial utility outside the FIELD and (ii) those which are owned solely by HGS, and shall be responsible for the cost and expense thereof. HGS shall be responsible for the filing, prosecution and maintenance of JOINT PATENTS which have significant commercial utility outside the FIELD and LICENSED PATENTS solely owned by HGS. HPC shall consult with MEDIMMUNE with respect to strategies for filing, prosecution and maintenance of patents and patent applications for which HPC bears responsibility under this Section 9.1, and shall keep MEDIMMUNE informed with regard to filing, prosecution and maintenance activity for such patents and patent applications, and with respect to such patents or patent applications which are solely owned by MEDIMMUNE or which are owned in part by MEDIMMUNE, HPC shall provide MEDIMMUNE with proposed patent applications and responses to office actions and official letters prior to filing thereof and in sufficient time to permit MEDIMMUNE to provide comments thereto. Similarly, HGS and HPC shall consult with and keep each other informed as aforesaid with respect to JOINT PATENTS for which it bears responsibility. HPC shall not allow any MEDIMMUNE PATENT to lapse or become abandoned without the written approval of MEDIMMUNE, which approval shall not be unreasonably withheld. With respect to any MEDIMMUNE PATENT which is jointly owned by HPC and as to which HPC elects not to effect filing thereof or to continue prosecution or maintenance thereof, HPC shall assign HPC's interest therein to MEDIMMUNE as the case may be. If HPC does not desire to file, prosecute or maintain a patent or patent application to an invention, HPC shall assign its ownership interest therein to MEDIMMUNE and shall no longer be responsible for the cost and expense thereof, and shall have no right to consult, review or comment with respect to the filing, prosecution and maintenance of said patent or patent application. (b) In the case of JOINT INVENTIONS and JOINT PATENTS which have significant commercial utility outside the FIELD, and in the event that HGS or MEDIMMUNE intends to use, license or sublicense rights to such JOINT INVENTIONS or JOINT PATENTS outside the FIELD, then HPC hereby grants to HGS or MEDIMMUNE, as the case may be, a sole and exclusive, worldwide, sublicensable license of HPC'S interest therein outside the FIELD, and HGS or MEDIMMUNE, as the case may be, does hereby agree to pay HPC: (i) A royalty of (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)percent ((CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)%) of the NET SALES of PRODUCTS sold by HGS or MEDIMMUNE or their AFFILIATES which are covered in the country where manufactured, used or sold by a VALID CLAIM of any JOINT PATENT which is licensed by HPC to HGS or MEDIMMUNE hereunder; and (ii)A royalty of (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) percent ((CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)%) of any royalties received by HGS or MEDIMMUNE for PRODUCTS sold by a licensee or sublicensee which in the country where manufactured, used or sold are covered by a VALID CLAIM of any JOINT PATENT which is licensed by HPC to HGS or MEDIMMUNE hereunder. 9.2In the event of the institution of any suit by a third party against MEDIMMUNE or HGS or its respective licensees for patent infringement involving the manufacture, use, import, export, offer for sale, sale, distribution or marketing of a PRODUCT outside the FIELD, MEDIMMUNE or HGS, as the case may be, shall promptly notify HPC in writing. As between MEDIMMUNE and/or HGS and HPC, MEDIMMUNE and/or HGS (but not HPC) shall be solely or jointly responsible, as the case may be, for the cost and expense of such action and any liability which results therefrom. 9.3In the event that MEDIMMUNE or HPC becomes aware of actual or threatened infringement of a LICENSED PATENT anywhere in the LICENSED TERRITORY by the sale of PRODUCT in the FIELD, that party shall promptly notify the other party in writing. HPC shall have the first right but not the obligation to bring, at its own expense, an infringement action against any THIRD PARTY with respect to a LICENSED PATENT as to which HPC retains a license hereunder. If HPC does not commence a particular infringement action within ninety (90) days of such notice, MEDIMMUNE or HGS, as the case may be, shall be entitled to bring such infringement action, at its own expense. The PARTY conducting an action under this Paragraph 9.3 shall have full control over its conduct, including settlement thereof provided such settlement shall not be made without MEDIMMUNE'S or HGS' prior written consent if the action is brought by HPC, which consent shall not be unreasonably withheld, provided, however, that in any action brought by HGS or MEDIMMUNE, such PARTY shall in good faith consult with HPC regarding such litigation and consider HPC's reasonable commercial interest in any settlement of such litigation. The parties shall reasonably assist one another and cooperate in any such litigation at the other's request, each such party paying its own costs and expenses. The party conducting the litigation shall periodically reimburse the other party for its reasonable and actual out-of-pocket expenses for assisting in the litigation, which reimbursement shall be made within thirty (30) days of receipt by the party conducting the litigation of itemized invoices from the assisting party documenting such expenses. 9.4 Any recovery made by a party as the result of an action for patent infringement it has conducted under Paragraph 9.3 shall be distributed as follows: (i)The party conducting the action shall recover its actual out -of-pocket expenses. (ii) To the extent that the recovery exceeds the total of item (i), the excess shall be kept by the party conducting the action, provided, however, that to the extent that (a) a recovery is made by HPC and is based on an award of lost sales/profits, and (b) HPC would have incurred a royalty obligation to MEDIMMUNE based upon such sales, MEDIMMUNE shall receive a proportion of the excess recovery corresponding to the royalty percentage it would have otherwise been due. 9.5 The parties shall periodically keep one another reasonably informed of the status of and of, their respective activities regarding, any such litigation or settlement thereof. SECTION 10 - DUE DILIGENCE 10.1 HPC shall select and use commercially reasonable efforts and diligence to research, develop and then sell at least one PRODUCT. The efforts of a sublicensee and/or an AFFILIATE of HPC shall be considered as efforts of HPC. (b)In the event that MEDIMMUNE reasonably believes that HPC is not making reasonable efforts under the circumstances to research, develop and then sell a selected PRODUCT in the FIELD then MEDIMMUNE shall provide written notice to HPC. Upon receipt of such written notice, HPC shall submit a reasonable development and/or marketing plan for PRODUCT in the FIELD. (c) In the event that HPC does not plan to research and develop in good faith at least one PRODUCT in the FIELD, HPC agrees to notify MEDIMMUNE in writing thereof. (d)If HPC fails to submit a plan as required by Section 10.1(b) and/or exert the efforts set forth in the plan MEDIMMUNE, in addition to any other remedy it may have, shall have the option to terminate the Agreement and licenses granted hereunder, pursuant to Section 12.2, which termination shall take effect sixty (60) days after written notice to HPC unless HPC submits a plan or exerts the required efforts, as the case may be, prior to expiration of such sixty (60) day period. (e) Within sixty (60) days after the end of each calendar year, HPC shall provide MEDIMMUNE with a written report with respect to its efforts to research, develop & commercialize PRODUCT in the FIELD for in such calendar year. SECTION 11 - ASSIGNMENT; SUCCESSORS. 11.1 This Agreement shall not, be assignable by either of the parties without the prior written consent of the other party (which consent shall not be unreasonably withheld), except that either party may assign this Agreement to an AFFILIATE or to a successor in interest or transferee of all or substantially all of the portion of the business to which this Agreement relates. 11.2 Subject to the limitations on assignment herein, this Agreement shall be binding upon and inure to the benefit of said successors in interest and assigns of MEDIMMUNE and HPC Any such successor or assignee of a party's interest shall expressly assume in writing the performance of all the terms and conditions of this Agreement to be performed by said party and such Assignment shall not relieve the Assignor of any of its obligations under this Agreement. SECTION 12 - TERM AND TERMINATION. 12.1 This Agreement, unless earlier termination as provided herein shall remain in full force and effect until HPC's obligations to pay royalties hereunder terminate pursuant to Section 3.4, at which time HPC shall have a fully paid up, non-cancelable license with respect to all PRODUCTS manufactured, used, sold, imported or exported by HPC. This Agreement may be extended or terminated, at any time, by mutual agreement by the PARTIES in writing. 12.2 In the event that HPC fails to meet its obligations under Sections 3 or 6, and such failure is not cured within sixty (60) days after written notice to HPC. MEDIMMUNE, in addition to any other remedy it may have, at its sole option may terminate this Agreement. 12.3 Termination of this Agreement under Paragraph 12.2 shall be without prejudice to any other rights or remedies which MEDIMMUNE may have hereunder, whether or not such rights or remedies arise from such breach which results in termination. 12.4 A PARTY may terminate this Agreement upon notice to the other PARTIES in the event of the filing by any other PARTY of a petition in bankruptcy or for liquidation; the request for or appointment of a receiver; execution upon any portion of the relevant PARTY'S business or assets; the relevant PARTY'S arrangement with or assignment for the benefit of creditors; or the relevant PARTY'S becoming unable to meet its obligations as they become due. 12.5 HPC's obligation to pay royalties hereunder shall survive termination of this Agreement. In addition, the obligations of Sections 5, 6 and 8 and of Paragraphs 2.3, 2.4, 12.3, 12.5 and 13.3 of this Agreement shall survive any termination of this Agreement. 12.6 Upon termination of this Agreement for any reason, nothing herein shall be construed to release either party from any obligation that matured prior to the date of such termination. SECTION 13 - GENERAL PROVISIONS. 13.1 The relationship between MEDIMMUNE, HGS and HPC is that of independent contractors. MEDIMMUNE, HGS and HPC are not joint venturers, partners, principal and agent. master and servant, employer or employee, and have no relationship other than as independent contracting parties. MEDIMMUNE shall have no power to bind or obligate HPC in any manner. Likewise, HPC shall have no power to bind or obligate MEDIMMUNE in any manner. 13.2 This Agreement sets forth the entire agreement and understanding between the parties as to the subject matter thereof and supersedes all prior agreements in this respect. There shall be no amendments or modifications to this Agreement, except by a written document which is signed by both parties. 13.3 This Agreement shall be construed and enforced in accordance with the laws of the State of Maryland without reference to its choice of law principles. 13.4 The headings in this Agreement have been inserted for the convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular article or section. 13.5 Any delay in enforcing a party's rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of a party's right to the future enforcement of its rights under this Agreement, excepting only as to an expressed written and signed waiver as to a particular matter for a particular period of time. 13.6 Notices. Any notices given pursuant to this Agreement shall be in writing and shall be deemed to have been given and delivered upon the earlier of (i) when received at the address set forth below. or (ii) three (3) business days after mailed by certified or registered mail postage prepaid and property addressed, with return receipt requested, or (iii) on the day when sent by facsimile as confirmed by certified or registered mail. Notices shall be delivered to the respective parties as indicated: To MEDIMMUNE: MedImmune, Inc. 35 West Watkins Mill Road Gaithersburg, MD 20878 ATTN: CEO Copy to: Carella, Byrne, Bain, Gilfillan, Cecchi, Stewart & Olstein 6 Becker Farm Road Roseland, NJ 07068 Fax No. (201) 597-0250 ATTN: Elliot M. Olstein, Esq. To HGS: Human Genome Sciences, Inc. 9410 Key West Avenue Rockville, MD 20850 ATTN: CEO To OraVax Merieux Co.: OraVax Merieux Co. 38 Sidney Street Cambridge, MA 02139 ATTN: Lance Gordon To Merieux OraVax S.N.C.: Merieux OraVax S.N.C. 58 Avenue Leclerc 69007 Lyon, France ATTN: HervJ Tainturier Copy to: Palmer & Dodge One Beacon Street Boston, MA 02108 Fax No. (617) 227-4420 ATTN: Michael Lytton IN WITNESS WHEREOF, the parties have executed this Agreement as of the date set forth above. For MEDIMMUNE, INC. For MERIEUX ORAVAX S.N.C. By: David M. Mott By: Paul Kirkconnell David M. Mott Paul Kirkconnell (Printed Name) (Printed Name) President and Operating Officer (Title) For ORAVAX MERIEUX CO. For HUMAN GENOME SCIENCES, INC. By: Thomas Monath Thomas Monath (Printed Name) (Printed Name) (Title) (Title) OraVax, Inc. and Pasteur Merieux SJrums & Vaccins S.A each hereby guarantee that their respective AFFILIATES, including but not limited to OraVax Merieux Co. and Merieux OraVax S.N.C. will perform all obligations under this Agreement. For ORAVAX, INC. For PASTEUR MERIEUX SERUMS & VACCINS S.A. By: Lance Gordon By: A. Lindberg Lance Gordon A. Lindberg (Printed Name) (Printed Name) (Title) (Title) EXHIBIT A Specification for LICENSED TECHNOLOGY and Software Deliverables (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)