License Agreement

Exhibit 10.48


LICENSE AGREEMENT


GLAXOSMITHKLINE


AND


3-DIMENSIONAL PHARMACEUTICALS, INC.


Note: Certain portions of this License Agreement and its exhibits, which ---- are identified by the symbol "[* *]", have been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.


LICENSE AGREEMENT
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THIS LICENSE AGREEMENT (hereinafter "AGREEMENT"), made as of the _____ day of January, 2002, between SmithKline Beecham Corporation, a Pennsylvania corporation having a place of business at One Franklin Plaza, Philadelphia, PA 19101 ("SBC") and Glaxo Group Limited, a company incorporated in England and Wales, having an office at Greenford Road, Greenford, Middlesex, UB6 OHE, United Kingdom ("GGL" and, together with SBC, GlaxoSmithKline or "GSK") and 3- Dimensional Pharmaceuticals, Inc., a Delaware corporation having a place of business at Three Lower Makefield Corporate Center, 1020 Stony Hill Road, Yardley, PA 19067 (herein referred to as "3DP"),


WITNESSETH THAT:
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WHEREAS, GSK is the owner of all right, title and interest in certain patents, identified in Appendix B hereto, and know-how, relating to two thrombopoietin peptide mimetics known internally at GSK as AF13948 and AF15705, as well as to certain PEGylated forms of these compounds known internally at GSK as GW350805 and GW395058, respectively;


WHEREAS GSK was developing, but has discontinued development of, GW350805 and W395058; and


WHEREAS, 3DP desires to obtain an exclusive license, and GSK is willing to grant an exclusive license to develop and commercialize such compounds on the terms and conditions set forth herein.


NOW, THEREFORE, in consideration of the covenants and obligations expressed herein, and intending to be legally bound, and otherwise to be bound by proper and reasonable conduct, the parties agree as follows:


1. DEFINITIONS
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1.01 "AFFILIATE" shall mean any corporation or other entity that controls, is controlled by or is under common control with a party to this Agreement. A corporation or other entity, as applicable, shall be regarded as in control of another corporation or other entity if it owns or directly or indirectly controls at least fifty percent (50%) of the voting stock of the other corporation or (a) in the absence of the ownership of at least fifty percent (50%) of the voting stock of a corporation or (b) in the case of a non-corporate entity, if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of such corporation or non- corporate entity, as applicable.


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1.02 "EFFECTIVE DATE" shall mean the date as of which this Agreement is effective and shall be the date of this Agreement first written above.


1.03 "FIELD" shall the mean the development, manufacture and sale of products that are peptides or modified peptides, including but not limited to PRODUCTS, that exhibit activity mimetic to thrombopoietin and that [* *]; excluding however for all purposes the development, manufacture and sale of products that [* *], including but not limited to PRODUCTS, [* *].


1.04 "KNOW-HOW" shall mean the technical information and know-how that is owned or controlled by GSK as of the EFFECTIVE DATE and that is necessary or useful for the development, manufacturing or regulatory approval of a PRODUCT and shall include, without limitation, biological, chemical, pharmacological, toxicological, clinical, assay, control and manufacturing data and any other information specifically relating to a PRODUCT. A non-comprehensive list of documentation encompassed within KNOW-HOW is set forth on Appendix A attached hereto, which may be amended from time to time by mutual agreement of the parties. In addition, if in the course of providing the services described in Appendix E, GSK develops additional information or know-how that is necessary or useful for the development, manufacturing or regulatory approval of a PRODUCT, KNOW-HOW shall also include such additional information and know-how. For the avoidance of doubt, it is understood and agreed that LICENSOR shall have no obligation to complete or finalize any draft reports or collections of data that may be included within KNOW-HOW.


1.05 "LICENSEE" shall mean 3DP.


1.06 "LICENSOR" shall mean GSK.


1.07 "NDA" shall mean an application for marketing approval of a pharmaceutical product in any country of the world.


1.08 "PATENTS" shall mean the patents and patent applications that are owned by LICENSOR as of the EFFECTIVE DATE, or to which LICENSOR otherwise has the right to grant licenses as of the EFFECTIVE DATE and that generically or specifically claim a PRODUCT or compositions thereof, methods of manufacturing a PRODUCT or compositions thereof, or methods of using a PRODUCT or compositions thereof. Also included within the definition of PATENTS are all continuations, continuations-in-part, divisions, patents of addition, utility models, reissues, renewals, extensions and supplementary patent certificates derived from or based on such patents and patent applications. The list of U.S. and PCT patent applications and patents encompassed within PATENTS as of the EFFECTIVE DATE is set forth in Appendix B attached hereto. Promptly following the EFFECTIVE DATE, LICENSOR shall amend Appendix B to include all patent applications and patents encompassed within PATENTS. In addition, PATENTS shall also include patents and patent applications filed in


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accordance with Section 7.01 as well as all continuations, continuations-in- part, divisions, patents of addition, utility models, reissues, renewals, extensions and supplementary patent certificates derived from or based on such patents and patent applications.


1.09 "PRODUCT" shall mean any of AF15705, AF13948, GW350805 and GW395058, each of which is more fully described on Appendix C, including alternative PEGylated or otherwise-modified forms thereof and including pharmaceutical compositions comprising such compounds or modified forms thereof, as well as any derivatives thereof that are discovered or developed by LICENSEE during the term of this AGREEMENT. "PRODUCTS" shall mean all of AF15705, AF13948, GW350805 and GW395058 and all alternative PEGylated or otherwise-modified forms thereof and including pharmaceutical compositions comprising such compounds or modified forms thereof, as well as any derivatives thereof that are discovered or developed by LICENSEE during the term of this AGREEMENT.


1.10 "TERRITORY" shall mean all the countries and territories in the world.


1.11 "THIRD PARTY(IES)" shall mean any party other than a party to this Agreement or an AFFILIATE of either party.


2. GRANT
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2.01 LICENSOR hereby grants to LICENSEE an exclusive license, with the right to grant sublicenses, under the PATENTS and KNOW-HOW to make, have made, use, offer to sell, sell and import products in the FIELD in the TERRITORY, subject to the terms and conditions of this Agreement.


3. PAYMENTS AND ROYALTIES
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3.01 In consideration for the exclusive license to PATENTS and KNOW-HOW granted to LICENSEE by LICENSOR under this Agreement, LICENSEE shall make the following stock issuances to LICENSOR (to be split equally between each GSK entity comprising LICENSOR) in accordance with the Stock Purchase Agreement attached hereto as Appendix D:


1. 500,000 shares of Common Stock of LICENSEE to be issued within five (5) business days after the EFFECTIVE DATE;


2. [* *] shares of Common Stock of LICENSEE to be issued within ten (10 days of the effective date of [* *], i.e., within ten (10) days of the date on which LICENSEE [* *]or to an analogous agency under the laws and regulations of any other country;


3. [* *] shares of Common Stock of LICENSEE to be issued within ten (10) days of [* *];


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4. [* *] shares of Common Stock of LICENSEE to be issued within ten (10) days of [* *];


5. [* *] shares of Common Stock of LICENSEE to be issued with ten (10) days of [* *].


[* *]


3.02 The stock issuances specified in Section 3.01 shall be the sole consideration for all rights granted to LICENSEE hereunder and for all obligations assumed by LICENSOR hereunder.


3.03 LICENSEE shall give LICENSOR prompt written notice of occurrence of each of the development milestones identified in Section 3.01(2),(3),(4), and (5).


4. DEVELOPMENT AND REGISTRATION
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4.01 As of the EFFECTIVE DATE, LICENSEE shall have full control and authority over, and shall be solely responsible for PRODUCTS, including but not limited to the development, registration, manufacture and commercialization of PRODUCTS in the TERRITORY. LICENSEE will exercise its reasonable efforts and diligence in developing and commercializing a PRODUCT in accordance with its business, legal, medical and scientific judgment, and in undertaking investigations and actions required to obtain appropriate governmental approvals to market a PRODUCT in the TERRITORY. All such activity shall be undertaken at LICENSEE's expense.


4.02 LICENSEE shall keep LICENSOR informed in writing, on an annual basis, of the status of the development of PRODUCTS throughout the TERRITORY.


4.03 Except as specified in Appendix E and in Section 4.04, LICENSOR shall have no obligation to provide any support to LICENSEE, whether financially, internal resource or otherwise, for the development and commercialization of PRODUCTS under the terms of this Agreement or otherwise.


4.04 Except to the extent transferred to LICENSEE pursuant to this Agreement, LICENSOR shall maintain its data, records, reports, and other information relating to the research and development of PRODUCTS to the same extent, and with the same level of care, as it would for other pharmaceutical products that it discovers, develops and directly commercializes, provided that such data, records, reports, and other information are in its possession or control as of the EFFECTIVE DATE.


5. SUPPLY, DISTRIBUTION AND LABELING
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5.01 LICENSEE shall be solely responsible for providing its clinical, promotional and commercial requirements of PRODUCTS throughout the TERRITORY.


5.02 LICENSEE shall be solely responsible for the distribution in the TERRITORY of PRODUCTS.


5.03 At Licensee's discretion, PRODUCTS sold by LICENSEE or its permitted sublicensees in the TERRITORY may bear a legend on its packaging stating that such PRODUCT is sold under a license from LICENSOR and/or bearing the patent numbers of patents claiming the PRODUCT that have been granted in the country of sale; provided that the exact content of such legend must be approved by LICENSOR prior to commercial launch in the TERRITORY if LICENSEE elects to use such legends. LICENSOR shall bear no responsibility for any limitation on damages recoverable from an infringer in an infringement suit as provided for under Section 7.05 herein if LICENSEE elects under this Section 5.03 to omit the US patent numbers of patents claiming the PRODUCT.


6. EXCHANGE OF INFORMATION, TRANSITIONAL SERVICES, AND CONFIDENTIALITY
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6.01 LICENSOR shall compile and transfer to LICENSEE, KNOW-HOW, including but not limited to the documentation listed on Appendix A, and shall otherwise provide certain transitional services, all as described in Appendix E. The obligation to transfer KNOW-HOW extends only to KNOW-HOW known to GSK as of EFFECTIVE DATE or developed by GSK prior to acceptance of an IND for a PRODUCT.


6.02 During the term of this Agreement and for five (5) years thereafter, irrespective of any termination earlier than the expiration of the term of this Agreement, LICENSOR shall not use or reveal or disclose to THIRD PARTIES any confidential information received from LICENSEE without first obtaining the written consent of LICENSEE, except as may be required to be disclosed to a governmental agency, in which case LICENSOR shall give LICENSEE prior notice of the details of such disclosure and of the requirements therefor. This confidentiality obligation shall not apply to such information which is or becomes a matter of public knowledge, or is already in the possession of LICENSOR, or is disclosed to LICENSOR by a THIRD PARTY having the right to do so, or is subsequently and independently developed by employees of LICENSOR or AFFILIATES thereof who had no knowledge of the confidential information disclosed. LICENSOR shall take reasonable measures to assure that no unauthorized use or disclosure is made by others to whom access to such information is granted.


6.03 During the term of this Agreement and for five (5) years thereafter, irrespective of any termination earlier than the expiration of the term of this Agreement, LICENSEE shall not use or reveal or disclose to THIRD PARTIES any confidential information received from


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LICENSOR in accordance with this Agreement or under the Confidential Information Agreement between LICENSOR and LICENSEE dated June 16, 2001, without first obtaining the written consent of LICENSOR. This confidentiality obligation shall not apply to KNOW-HOW or to such information which is or becomes a matter of public knowledge, or is already in the possession of LICENSEE, or is disclosed to LICENSEE by a THIRD PARTY having the right to do so, or is subsequently and independently developed by employees of LICENSEE or AFFILIATES thereof who had no knowledge of the confidential information disclosed. LICENSEE shall take reasonable measures to assure that no unauthorized use or disclosure is made by others to whom access to such information is granted.


6.04 Either party to this Agreement may release the announcement attached hereto as Appendix F. Otherwise, no public announcement or other disclosure to THIRD PARTIES concerning the existence of or terms of this Agreement shall be made, either directly or indirectly, by any party to this Agreement, except as may be legally required or as may be required for recording purposes, without first obtaining the written approval of the other party and agreement upon the nature and text of such announcement or disclosure; provided however, that in the event of any disclosure required by law or required for recording purposes, the disclosing party shall notify the other party prior to any such disclosure and reasonably cooperate with any requests to limit or otherwise protect any such disclosures.


The above notwithstanding, without the prior consent of LICENSOR, LICENSEE may disclose to third parties information concerning the development and commercialization of PRODUCTS provided that it shall not disclose the terms of this Agreement, except to the extent already disclosed by the announcement attached as Appendix F, without the prior written consent of LICENSOR.


A party desiring to make any other public announcement or other disclosure shall inform the other party of the proposed announcement or disclosure in reasonably sufficient time prior to release, and shall provide the other party with a written copy thereof, in order to allow such other party to comment upon such announcement or disclosure.


6.05 LICENSOR shall not submit for written or oral publication any manuscript, abstract or the like which includes data or other information relating to either PRODUCT without first obtaining the prior written consent of LICENSEE.


6.06 Nothing in this Agreement shall be construed as preventing or in any way inhibiting LICENSEE from complying with statutory and regulatory requirements governing the development, manufacture, use and sale or other distribution of PRODUCTS in any manner that it reasonably deems appropriate, including, for example, by disclosing to regulatory authorities confidential or other information received from LICENSOR or THIRD PARTIES.


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6.07 All confidential information disclosed by one party to the other 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 the other 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 ensure that the court, other tribunal or appointee maintains such information in confidence in accordance with the terms of this Agreement.


7. PATENT PROSECUTION AND LITIGATION
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7.01 Each party shall have and retain sole and exclusive title to all inventions, discoveries and know-how which are made, conceived, reduced to practice or generated solely by its employees, agents, or other persons acting under its authority in the course of or as a result of the performance of activities under this Agreement. Each party shall own a fifty percent (50%) undivided interest in all such inventions, discoveries and know-how made, conceived, reduced to practice or generated jointly by employees, agents, or other persons acting under the authority of both parties in the course of or as a result of the performance of activities under this Agreement. For the avoidance of doubt, it is understood and agreed that LICENSOR is not obligated to, and has no intent of being involved at all with LICENSEE in the development or commercialization of PRODUCT under this Agreement, and that the responsibility for the development and commercialization of PRODUCT rests solely with LICENSEE, except as provided in Appendix E and in Section 4.04. LICENSOR shall have the right to file, prosecute and maintain patent applications and patents directed to inventions and discoveries that are owned in whole by LICENSOR in accordance with this Section 7.01. LICENSEE shall have the right to file, prosecute and maintain patent applications and patents directed to inventions and discoveries that are owned in whole by LICENSEE in accordance with this Section 7.01. Both parties shall have the right to file, prosecute and maintain patent applications and patents directed to inventions and discoveries that are jointly owned by LICENSEE and by LICENSOR in accordance with this Section 7.01 and the parties shall agree upon which of them shall take the lead in filing, prosecuting and maintaining such patent applications at the equal expense of both parties. If either party declines to exercise its rights to file, prosecute and maintain patent applications or patents hereunder, the other party shall have the right to file, prosecute and maintain such patent applications and patents at its own expense.


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7.02 LICENSOR shall disclose to LICENSEE the complete texts of all patents and patent applications that are PATENTS as well as of all correspondence to or from the U.S. Patent and Trademark Office, and other patent offices around the world, relating to such patents and patent applications, as well as all information received concerning the institution or possible institution of any interference, opposition, re-examination, reissue, revocation, nullification or any official proceeding involving a PATENT anywhere in the TERRITORY. All such disclosures shall be subject to the provisions of Section 6.03. LICENSEE shall have the right to comment upon all patent office communications concerning such patents and patent applications as well as on all proposed responses to such communications.


7.03 In addition, LICENSOR shall consult with patent attorneys appointed by LICENSEE prior to taking any action that would result in the narrowing of claims that cover the making, using, or selling of a PRODUCT, or that would otherwise reduce the patent coverage for a PRODUCT, provided that the fees and expenses of the appointed patent attorneys shall be paid by LICENSEE. LICENSEE shall have the right to assume responsibility for any PATENT or any part of a PATENT that covers the making, using or selling of a PRODUCT and that LICENSOR intends to abandon or otherwise cause or allow to be forfeited.


7.04 In the event of the institution of any suit by a THIRD PARTY against LICENSOR, LICENSEE or its sublicensees for patent infringement involving the manufacture, use, sale, distribution or marketing of PRODUCT anywhere in the TERRITORY, the party sued shall promptly notify the other party in writing. LICENSEE shall have the right but not the obligation to defend such suit at its own expense. LICENSOR and LICENSEE shall assist one another and cooperate in any such litigation at the other's reasonable request without expense to the requesting party.


7.05 In the event that LICENSOR or LICENSEE becomes aware of actual or threatened infringement of a patent claim in a PATENT, which claim covers the making, using, or selling of a product in the FIELD anywhere in the TERRITORY, that party shall promptly notify the other party in writing. LICENSEE shall have the first right but not the obligation to bring, at its own expense, an infringement action against any THIRD PARTY and, if required in order to bring or maintain such action or to recover the full measure of damages, to use LICENSOR's name in connection therewith and to include LICENSOR as a party thereto. If LICENSEE does not commence a particular infringement action within ninety (90) days, LICENSOR, if LICENSEE consents, shall be entitled to bring such infringement action at its own expense. The party conducting such action shall have full control over its conduct, including settlement thereof, subject to Paragraph 7.07. In any event, LICENSOR and LICENSEE shall assist one another and cooperate in any such litigation at the other's reasonable request without expense to the requesting party.


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7.06 LICENSOR and LICENSEE shall recover their respective actual out-of- pocket expenses, or equitable proportions thereof, associated with any litigation or settlement thereof from any recovery made by any party. Any excess amount shall be kept by the party that conducted the litigation.


7.07 The parties shall keep one another informed of the status of and of their respective activities regarding any litigation or settlement thereof concerning PRODUCT, provided that no settlement or consent judgment or other voluntary final disposition of any suit defended or action brought by one party pursuant to this Article 7 may be entered into without the consent of the other party if such settlement would require the non-settling party to be subject to an injunction outside the FIELD or to make a monetary payment for which the non- settling party is not indemnified by the settling party or would adversely affect the non-settling party's rights under this Agreement.


8. TRADEMARKS AND NON-PROPRIETARY NAMES
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8.01 LICENSEE, at its expense, shall be responsible for the selection, registration and maintenance of all trademarks that it employs in connection with PRODUCT in the TERRITORY and shall own and control such trademarks. Nothing in this Agreement shall be construed as a grant of rights, by license or otherwise, to LICENSOR to use such trademarks for any purpose.


9. TERM AND TERMINATION
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9.01 Unless otherwise terminated, this Agreement shall expire upon the expiration, lapse or invalidation of the last remaining PATENT in any country of the TERRITORY that covers the making, using, selling, or importing of PRODUCT. Expiration of this Agreement under this provision shall not preclude LICENSEE from continuing to market PRODUCT and to use KNOW-HOW without further payments to LICENSOR.


9.02 If either party fails or neglects to perform material covenants or provisions of this Agreement and if such default is not corrected within thirty (30) days after receiving written notice from the other party with respect to such default, such other party shall have the right to terminate this Agreement by giving written notice to the party in default; provided, however, that if such default is contested in accordance with Article 14, then the termination shall not take effect until the matter is finally resolved.


9.03 LICENSEE may terminate this Agreement at any time and at its discretion by giving thirty (30) days written notice thereof to LICENSOR. Upon any termination by LICENSOR pursuant to Section 9.02 or LICENSEE pursuant to this Section 9.03, in addition to the provisions of Article 10 below, LICENSEE shall return to LICENSOR any KNOW-HOW


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provided to LICENSEE hereunder. In addition, LICENSEE shall grant to LICENSOR a license under LICENSEE's rights in all pre-clinical, clinical, regulatory, manufacturing and other documentation and related know-how and patents relating to PRODUCTS developed and/or commercialized hereunder under commercially reasonable terms to be negotiated in good faith between the parties.


9.04 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 or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of the 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 creditors.


9.05 Notwithstanding the bankruptcy of LICENSOR, or the impairment of performance by LICENSOR of its obligations under this Agreement as a result of bankruptcy or insolvency of LICENSOR, LICENSEE shall be entitled to retain the licenses granted herein, subject to LICENSOR's rights to terminate this Agreement for reasons other than bankruptcy or insolvency as expressly provided in this Agreement.


10. RIGHTS AND DUTIES UPON TERMINATION
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10.01 Upon termination of this Agreement, LICENSOR shall have the right to retain any shares of Common Stock of LICENSEE already issued to LICENSOR by LICENSEE under this Agreement or the Stock Purchase Agreement, and LICENSEE shall issue to LICENSOR all shares of Common Stock that may be due as of the effective date of termination under Section 3.01.


10.02 Termination of this Agreement shall terminate all outstanding obligations and liabilities between the parties arising from this Agreement, including without limitation the licenses granted in Article 2 hereof, except those described in Paragraphs 6.02, 6.03, 6.07, 7.01, 9.01, 9.03, 11.06, 13.01 and 14.01 and Article 10, as well as any other provision which, by its terms, is stated to survive the termination ...