Ex-10.30 Technology Transfer Agreement, dated December 20, 2006

EX-10.30 4 b63539a4exv10w30.txt EX-10.30 TECHNOLOGY TRANSFER AGREEMENT, DATED DECEMBER 20, 2006 EXHIBIT 10.30 TECHNOLOGY TRANSFER AGREEMENT THIS TECHNOLOGY TRANSFER AGREEMENT (the "Agreement") is entered into effective as of the 20th day of December 2006 (the "Effective Date"), by and between Mallinckrodt Inc., a Delaware corporation, with a place of business at 675 McDonnell Boulevard, Hazelwood, Missouri 63042 ("MALLINCKRODT"), and Molecular Insight Pharmaceuticals, Inc., a Delaware corporation, with an office at 160 Second Street, Cambridge, Massachusetts 02142 ("MIP"). WITNESSETH THAT: WHEREAS, MIP plans to enter a license agreement with Novartis Pharma AG ("Novartis") for the right to make, use, sell, offer for sale and import the Product (as defined in Section 1 below); and WHEREAS, MALLINCKRODT owns or is the licensee of certain Patent Rights (as defined in Section 1 below), claiming a method of stabilization of radiopharmaceuticals; and WHEREAS, MALLINCKRODT has technology and capability to manufacture Vials (as defined in Section 1 below) and the Product; and WHEREAS, MIP desires to obtain a license to the Patent Rights and Technology (as defined in Section 1 below), and to receive a transfer of the Technology for the Vials and the Product as detailed in EXHIBIT B; and WHEREAS, MALLINCKRODT is willing to grant the license and to provide the transfer of the Technology upon the terms and conditions set forth in this Agreement; NOW THEREFORE, in consideration of the premises and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, MALLINCKRODT and MIP agree as follows: 1. DEFINITIONS. Wherever used in this Agreement, the following capitalized terms shall have the meanings set forth below: 1.1 "AFFILIATE" means any entity that directly or indirectly controls or is controlled by or is under common control with a Party to this Agreement. For purposes of this definition, "control" or "controlled" means ownership directly or through one or more Affiliates, of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interest in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby a Party controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity, or the ability to cause the direction of the management or policies of a corporation or other entity. 1.2 "AGREEMENT" shall mean this Technology Transfer Agreement together with all exhibits, schedules and appendices hereto, all as the same may be amended, modified or supplemented from time-to-time in accordance with the terms of this Agreement. 1.3 "CHANGE OF CONTROL" shall mean any of the following events: (i) any Third Party (or group of Third Parties acting in concert) becomes the beneficial owner, directly or indirectly, of fifty percent (50%) or more of the voting power of the stock then outstanding of MIP; (ii) MIP consolidates with or merges into another corporation or entity, or any corporation or entity consolidates with or merges into MIP, in either event pursuant to a transaction in which fifty percent (50%) or more of the total voting power of the stock outstanding of the surviving entity normally entitled to vote is not held by Persons holding more than fifty percent (50%) of the outstanding shares of MIP prior to such consolidation or merger; (iii) any Third Party (or group of Third Parties acting in concert) obtains the power to direct or cause the direction of the management and policies of MIP by any lawful means whatsoever; or (iv) MIP conveys, transfers or leases all or substantially all of its assets. 1.4 "COMPOUND" means DOTA-Tyr(3)-Octreotide. 1.5 "EFFECTIVE DATE" shall mean the later to occur of (i) the date upon which MALLINCKRODT receives written notice from MIP that MIP has executed the agreement with Novartis as referenced in Section 8 hereof and (ii) the date upon which the Termination Letter shall have been executed by and between MALLINCKRODT and Novartis. 1.6 "FDA" means the United States Food and Drug Administration and any successor agency thereto. 1.7 "GOOD MANUFACTURING PRACTICES" or "GMP" means the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant governmental authority having jurisdiction over the development, manufacture or sale of the Product in any other country pursuant to its regulations, guidelines or otherwise. 1.8 "MALLINCKRODT CONFIDENTIAL INFORMATION" means all Technology, data and other information that is disclosed by MALLINCKRODT to MIP during the course of providing the technology transfer services under this Agreement to the extent that such 2 information as of the date of disclosure to MIP is not (i) known to MIP other than by virtue of a prior confidential disclosure to MIP by MALLINCKRODT; or (ii) disclosed in published literature, or otherwise generally known to the public through no fault or omission of MIP; or (iii) obtained from a Third Party free from any obligation of confidentiality to MALLINCKRODT. 1.9 "MIP CONFIDENTIAL INFORMATION" means all information about MIP's technical requirements with respect to the Product which is disclosed by MIP to MALLINCKRODT and designated "Confidential" in writing by MIP at the time of disclosure to MALLINCKRODT to the extent that such information is not (i) as of the date of disclosure to MALLINCKRODT demonstrably known to MALLINCKRODT other than by virtue of a prior confidential disclosure to MALLINCKRODT by MIP; or (ii) as of the date of disclosure or thereafter is disclosed in published literature, or otherwise generally known to the public through no fault or omission of MALLINCKRODT; or (iii) obtained from a Third Party free from any obligation of confidentiality to MIP; or (iv) MALLINCKRODT can demonstrate by competent evidence was developed by MALLINCKRODT or its Affiliates without access to or the benefit of MIP Confidential Information. MIP will not disclose any information to MALLINCKRODT regarding MIP's marketing plans or commercialization with respect to the Product or to the Indium 111 labelled Compound for dosimetry planning for OctreoTher therapy delivery and to the extent disclosed, such information shall not be deemed MIP Confidential Information for purposes of this Agreement and MALLINCKRODT shall not be under any limitations with respect thereto. 1.10 "MIP FIELD" means human oncology therapeutic use. 1.11 "OCTREOTHER(R)" means the trademark selected and owned by Novartis for the Product. 1.12 "PARTY" OR "PARTIES" shall mean MIP or MALLINCKRODT, or MIP and MALLINCKRODT, whichever the context admits. 1.13 "PATENT RIGHTS" means the patents and patent applications listed in EXHIBIT A, and patents issuing on them, including any division, continuation, continuation-in-part, renewal, extension, re-examination, reissue or foreign counterpart thereof. 1.14 "PERSON" shall mean any individual, corporation, partnership, association, joint stock company, trust, unincorporated organization or government or political subdivision thereof. 3 1.15 "PRODUCT" means the OctreoTher Hot Liquid which is the radiolabeled peptide (90)Y DOTA-Tyr(3)-Octreotide (Yttrium ((90)Y) SMT 487) in a solution prepared from the reconstituted Vials. 1.16 "REGULATORY AUTHORITY" shall mean the FDA or any foreign counterpart or additional governmental or regulatory agencies in the Territory with responsibility for marketing approval or authorization of the Product. 1.17 "TECHNOLOGY" means and is limited to the specific materials, technical information, know-how, expertise, trade secrets and the associated documentation in MALLINCKRODT's possession and required for: - the manufacturing and quality control of the Vials; and - the manufacturing and quality control of the Product. MIP acknowledges that the term "Technology" does not include any know-how, expertise or trade secret information, if any, that MALLINCKRODT may have regarding the labelling of the Compound with Indium-111. Without limiting the generality of the preceding sentence, MALLINCKRODT shall be under no obligation whatsoever to provide a Technology transfer to MIP with respect to the labelling of the Compound with Indium-111. 1.18 "TERRITORY" shall mean all of the countries and territories of the world. 1.19 "TERMINATION LETTER" shall mean an agreement to be entered into by MALLINCKRODT and Novartis providing for the termination of (i) that certain agreement, dated December 1, 1992, between Sandoz Pharma Ltd. (now Novartis) and Mallinckrodt Medical Inc. (now MALLINCKRODT) relating to the development, manufacture and marketing of molecules for radiodiagnostic and radiotherapeutic purposes and (ii) that certain agreement, dated October 1996, under which MALLINCKRODT and Novartis agreed to collaborate in the development, manufacture and marketing of the Product. 1.20 "THIRD PARTY" shall mean any Person or other entity other than MIP, MALLINCKRODT or their respective Affiliates. 1.21 "VIAL" means the OctreoTher SMT 487 Reaction Vial which is a vial containing lyophilized material comprised of DOTA-Tyr(3)- Octreotide, gentisic acid, inositol, ascorbic acid, and sodium hydroxide that is reconstituted to make the Product. 2. GRANT OF LICENSE, TERM, RIGHTS AND OBLIGATIONS. 2.1 LICENSE GRANTED TO MIP UNDER THE PATENT RIGHTS AND TECHNOLOGY. Subject to 4 the terms, conditions and limitations of this Agreement, MALLINCKRODT hereby grants to MIP a non-exclusive, worldwide license under all of MALLINCKRODT's right, title and interest in the Patent Rights and Technology, to manufacture, use, sell, offer for sale and import the Product in the MIP Field, as well as to use the Indium 111 labelled Compound for dosimetry purposes in relation to the Product therapy administration; provided that MIP can only exercise the foregoing rights with respect to an Indium 111 labelled Compound to the extent the FDA or other Regulatory Authority expressly requires the development and use thereof for dosimetry purposes as a condition to its approval of the Product for marketing and sale, and provided further that MIP may under no circumstances market and sell an Indium-111 labelled Compound separately as a diagnostic imaging agent (i.e., the Indium-labelled Compound can only be marketed and sold for dosimetry purposes in relation to Product therapy administration). Except as specifically provided in this Agreement, no licenses are granted by MALLINCKRODT and MALLINCKRODT retains all other rights under the Patent Rights and the Technology. MIP shall have the right to grant sublicenses with respect to the license rights provided for in this Section 2.1 solely on the following terms and conditions. (a) Without MALLINCKRODT'S prior written consent, which MALLINCKRODT may grant or withhold in its sole and absolute discretion, and notwithstanding anything to the contrary forth in this Agreement, MIP cannot sublicense any rights to a direct competitor of MALLINCKRODT, as listed in EXHIBIT G. (b) In the event MIP intends to grant rights of any nature whatsoever with respect to the commercialization, including but not limited to the marketing, promoting, distributing, importing or selling, of the Product to any Third Party(ies), MIP must first offer any such commercialization rights, in writing, to MALLINCKRODT. Upon receipt of such offer, MALLINCKRODT shall have sixty (60) days to inform MIP whether it desires to enter into good faith negotiations with MIP for a definitive agreement with respect to such rights. Mallinckrodt's rights under this subsection are subject to MIP's obligation to first provide Novartis with "rights of first discussions", as set forth in Section 6.5 of the agreement to be entered into between MIP and Novartis relating to the Product, as referenced in Section 8 of this Agreement. (c) MIP shall in all events remain directly responsible to MALLINCKRODT for the performance by any sublicensee of any and all obligations and/or responsibilities assumed by such sublicensee under this Agreement. 5 (d) The terms and conditions of any Third Party sublicense shall be consistent in all respects with the terms of this Agreement. (e) MIP shall cause each sublicensee to execute any and all additional documents reasonably requested by MALLINCKRODT to reflect the conditions set forth above. 2.2 TERM OF LICENSE. The term of the license set forth in Section 2.1 shall commence on the Effective Date and, unless sooner terminated pursuant to Article 9 of this Agreement, shall terminate on a country-by-country basis on the date when MIP discontinues manufacture and/or sale of the Product, as the case may be, in such country. 2.3 TRANSFER OF THE TECHNOLOGY. (a) During the period commencing no later than thirty (30) days after the Effective Date and terminating not later than one-hundred eighty (180) days thereafter, MALLINCKRODT shall make available research and development and production personnel to physically transfer the Technology to MIP personnel. Such MALLINCKRODT personnel shall be knowledgeable about the Technology, shall be reasonably capable of transferring the Technology to MIP, and shall use commercially reasonable efforts to transfer the Technology to MIP personnel. MIP must at all times during the one-hundred eighty (180) period referenced in the preceding sentence provide knowledgeable and capable personnel to be the recipients of the transfer of the Technology. Exhibit B is an all-inclusive list of the specific services to be provided by MALLINCKRODT personnel hereunder. MALLINCKRODT shall transfer the Technology to MIP on an "AS IS" basis. (b) MALLINCKRODT's obligation to provide transfer of the Technology is in all events limited to ninety (90) work days (i.e., one MALLINCKRODT employee working ninety (90) days at eight (8) hours per day) or completion by MALLINCKRODT of the specific services identified in Exhibit B, whichever comes first. (c) For purposes of calculating the amount of time devoted by MALLINCKRODT personnel to the transfer of Technology required under this Agreement, each response by MALLINCKRODT to a request by MIP or its Affiliates for assistance, whether in the form of a written communication, oral request, or otherwise, shall be accounted for as an expenditure of time equal to the greater of (i) four (4) hours or (ii) the actual time spent by MALLINCKRODT responding to the request for assistance. For example, if an employee of MIP requests, by telephone call, assistance with Technology transfer and a MALLINCKRODT employee devotes two (2) hours responding to the request, MALLINCKRODT shall, for 6 purposes of this Agreement, be considered to have provided four (4) hours of Technology transfer services. (d) In the event the MALLINCKRODT personnel referenced above are required to travel away from their regular place of employment, MIP will reimburse MALLINCKRODT for all reasonable travel and living expenses incurred by such personnel upon submission by MALLINCKRODT of an itemized account of expenses for which it seeks reimbursement. Travel time will be considered working time of MALLINCKRODT employees for purposes of determining MALLINCKRODT's compliance with its obligations under this Section. 2.4 ADDITIONAL TRANSFER OF THE TECHNOLOGY. If, during the first twelve (12) months this Agreement is in effect, MIP determines that it requires additional Technology transfer from MALLINCKRODT, MIP shall provide to MALLINCKRODT a list of its specific additional requirements for MALLINCKRODT's consideration. If the request is acceptable to MALLINCKRODT in its reasonable discretion, MALLINCKRODT shall provide up to an additional ninety (90) work days in thirty (30) work day increments of Technology transfer during a similar period and in the manner set forth in Section 2.3. MIP shall make the payment described in Section 3(d) prior to the commencement of such additional Technology transfer. 2.5 CERTIFICATION BY MALLINCKRODT. Upon completion by MALLINCKRODT of its obligation(s) to transfer the Technology under Sections 2.3 and/or 2.4 of this Agreement, MALLINCKRODT shall provide a written certification of completion to MIP in the form attached to this Agreement as EXHIBIT C. Absent manifest error demonstrated by MIP, and subject to MIP's rights to additional technical support, if applicable, as set forth in Section 2.4, such certification shall for all purposes be deemed conclusive and final evidence of MALLINCKRODT's full and complete performance of its Technology transfer obligations to MIP. 2.6 LIAISON. Each of MIP and MALLINCKRODT shall within ten (10) days of the execution of this Agreement identify a primary contact person to act as liaison for the purposes of implementing this Agreement. 3. PAYMENTS. MIP shall make the following payments to MALLINCKRODT by wire transfer in United States Dollars to an account designated by MALLINCKRODT: (a) $** concurrent with the execution of this Agreement; *Confidential Treatment Requested* 7 (b) $** upon commencement by MALLINCKRODT of the Technology transfer as detailed in Exhibit B; (c) $** upon completion of the Technology transfer as detailed in Exhibit B; and (d) $** for each thirty (30) day increment of the additional Technology Transfer pursuant to Section 2.4, payable upon commencement by MALLINCKRODT of each such increment. 4. SALE OF OCTREOTHER VIALS. 4.1 MALLINCKRODT hereby sells and MIP buys the 1,800 Vials in MALLINCKRODT's possession. The purchase price is U.S. $**, ** percent (**%) of which is payable by wire transfer concurrent with the execution of this Agreement and the balance of which is payable upon confirmation of delivery to MIP. 4.2 Terms of delivery for the Vials shall be FOB, MALLINCKRODT's facility in Petten, The Netherlands. MALLINCKRODT shall cause the Vials to be shipped within thirty (30) days after the later of execution of this Agreement and receipt by MALLINCKRODT of the ** percent (**%) installment, as described in Section 4.1 above, unless directed otherwise by MIP and agreed upon by MALLINCKRODT in its discretion. 4.3 MALLINCKRODT warrants that the Vials have been manufactured in accordance with GMP standards and meet the specifications in Section 5.2.1 of the Yttrium ((90)Y) SMT 487 IND Information Manufacturing Description attached to this Agreement as EXHIBIT D. MALLINCKRODT MAKES NO OTHER WARRANTY, EXPRESS OR IMPLIED, WITH RESPECT TO THE VIALS, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, EXCEPT AS SET FORTH IN SECTION 6. 5. MIP RESPONSIBILITIES. Upon the Effective Date, MIP will be solely responsible, at its own cost, for all regulatory filings, development and clinical and commercial manufacture of all Product. MALLINCKRODT will have no responsibilities or obligation of any kind with respect to these activities. 6. REPRESENTATION AND WARRANTY. 6.1 MALLINCKRODT represents and warrants to MIP that, upon execution of the *Confidential Treatment Requested* 8 Termination Agreement by Novartis, it will have the right to grant the license granted pursuant to Section 2.1 of this Agreement, and that the license so granted will not conflict with or violate the terms of any agreement between MALLINCKRODT and any Third Party. 7. TREATMENT OF CONFIDENTIAL INFORMATION. 7.1 CONFIDENTIALITY. 7.1.1 Subject to MIP's rights with respect to the licenses as specifically provided for in Section 2.1 of this Agreement, MIP and MALLINCKRODT each agree that during the term of this Agreement and for five (5) years thereafter, it will keep confidential, and will cause its Affiliates and sublicensees to keep confidential, all MALLINCKRODT Confidential Information or MIP Confidential Information, as the case may be, which is disclosed to it or to any of its Affiliates and sublicensees pursuant to this Agreement. Neither MIP, its Affiliates or sublicensees, nor MALLINCKRODT shall use Confidential Information of the other Party except as expressly permitted under this Agreement. 7.1.2 Each Party agrees that it will disclose the other Party's Confidential Information to its officers, employees, agents or Affiliates only if and to the extent necessary to carry out its responsibilities under this Agreement and shall limit disclosures to the extent possible consistent with such responsibilities. MALLINCKRODT agrees not to disclose MIP Confidential Information to any Third Parties under any circumstance without written permission from MIP. MALLINCKRODT shall take such action, and shall cause its Affiliates to take such action, to preserve the confidentiality of MIP Confidential Information as it would customarily take to preserve the confidentiality of its own Confidential Information. Upon termination of this Agreement, MALLINCKRODT will, upon MIP's written request, either return or, in MALLINCKRODT's discretion, destroy all the MIP Confidential Information disclosed to it by MIP pursuant to this Agreement, including all copies and extracts of documents, within sixty (60) days of the request except for one (1) copy which may be kept for the purpose of complying with continuing obligations under this Agreement. 7.1.3 The Parties represent that all employees who shall have access to Confidential Information are or will be bound by agreements to maintain such information in confidence. 7.1.4 Notwithstanding any of the foregoing provisions, MIP specifically acknowledges and agrees that all confidential and proprietary information provided by 9 MALLINCKRODT to MIP in connection with the negotiation, execution and performance of this Agreement shall also be and remain subject to the terms of that certain Confidentiality Agreement, dated November 14, 2005, between the Parties (the "MALLINCKRODT Confidentiality Agreement.") In the event of any inconsistencies between the terms of this Agreement and the MALLINCKRODT Confidentiality Agreement, the terms of the MALLINCKRODT Confidentiality Agreement shall govern, except that MIP shall, without regard to the terms of the MALLINCKRODT Confidentiality Agreement, be authorized to communicate MALLINCKRODT Confidential Information to a permitted sublicensee hereunder (as provided for in Section 2.1) to the extent required for the performance by such permitted sublicensee of the obligations that are subject to the sublicense. 7.2 PUBLICITY. Except as required by law, and except for a mutually approved press release to be issued upon the signing of this Agreement, neither Party may disclose the terms of this Agreement without the written consent of the other Party; provided, however, that MIP may disclose the terms, or provide copies, of this Agreement as necessary in the normal course of business to bankers, investors and others in order to obtain financing. 7.3 DISCLOSURE REQUIRED BY LAW. If MALLINCKRODT is requested to disclose MIP Confidential Information in connection with a legal or administrative proceeding or is otherwise required by law to disclose the Confidential Information, it will give MIP prompt notice of such request. MIP may seek an appropriate protective order or other remedy or waive compliance with the provisions of this Agreement. If MIP seeks a protective order or other remedy, MALLINCKRODT will cooperate at MIP's sole cost and expense. If MIP fails to obtain a protective order or waive compliance with the relevant provisions of this Agreement, MALLINCKRODT will disclose only that portion of MIP Confidential Information which its legal counsel determines it is required to disclose. 8. NO OTHER AGREEMENTS. Except for the MALLINCKRODT Confidentiality Agreement, this Agreement is the sole agreement between the Parties with respect to the subject matter hereof and supersedes all other agreements and understandings between the Parties with respect to same; provided, however, the execution of the proposed agreement between MIP and Novartis with respect to the Product prior to or on even date with this Agreement, together with the execution by MALLINCKRODT and Novartis of the Termination Agreement, are condition precedents to the force and effectiveness of this Agreement. If such agreement is not executed in 10 the time described, this Agreement will lapse and the Parties will have no obligation of any kind to each other; provided that such lapse will have no effect on the continuing enforceability of the MALLINCKRODT Confidentiality Agreement in accordance with its terms. 9. TERMINATION AND DISENGAGEMENT. 9.1 MATERIAL BREACH. If either MIP or MALLINCKRODT shall breach any material obligation contained in this Agreement and, in the case of a breach capable of remedy, such breach shall not be cured within sixty (60) days (ten (10) days with respect to a payment default) after written notice to the breaching Party, the Party not in breach may terminate this Agreement by notice without prejudice to the accrued rights of either Party. 9.2 TERMINATION FOR INSOLVENCY. Either Party may terminate this Agreement immediately upon delivery of written notice to the other Party: (i) upon the institution by or against the other Party of insolvency, receivership or bankruptcy proceedings or any other proceedings for the settlement of the other Party's debts; provided, however, with respect to involuntary proceedings, that such proceedings are not dismissed within one hundred and twenty (120) days; (ii) upon the other Party's making an assignment for the benefit of creditors; or (iii) upon the other Party's dissolution or ceasing to do business. 9.3 CHANGE OF CONTROL. MALLINCKRODT may terminate this Agreement immediately in the event there is a Change in Control, provided such Change in Control results in MIP being owned by a direct competitor of MALLINCKRODT, as listed on Exhibit G hereto. 9.4 EFFECT OF TERMINATION. (a) The expiration of termination of this Agreement for any reason shall not relieve the Parties from any obligations that accrued prior to such expiration or termination, including without limitation MALLINCKRODT's right to receive all payments accrued hereunder as of the effective date of expiration or termination. In addition, except where explicitly elsewhere provided herein, termination of this Agreement for any reason, or expiration of this Agreement, will not affect any rights or obligations which, from the context thereof, are intended to survive termination or expiration of this Agreement. (b) In the event this Agreement is rightfully terminated by MALLINCKRODT pursuant to Sections 9.1, 9.2 or 9.3, (i) all of MIP's rights to the Patent Rights and the Technology shall immediately revert to MALLINCKRODT, including but not limited to all rights under the license conveyed pursuant to Section 2.1 of this Agreement, and 11 (ii) MALLINCKRODT shall be entitled to immediately cease all Technology transfer activities otherwise remaining to be performed under this Agreement. (c) In the event this Agreement is rightfully terminated by MIP pursuant to Sections 9.1 or 9.2, MIP's license rights in and to the Patent Rights and the Technology shall nevertheless continue in full force and effect in accordance with the terms of this Agreement. 10. INDEMNIFICATION. MIP hereby agrees to indemnify, defend and hold harmless MALLINCKRODT (and all officers, directors, employees, agents and other Affiliates of MALLINCKRODT) for any and all claims, liabilities, damages, losses, costs or expenses (including but not limited to reasonable attorneys' fees) arising from or in connection with (i) any breach by MIP of a material obligation under this Agreement, (ii) clinical trials pursued by MIP, its Affiliates or sublicensees with respect to the Product or the Compound or (iii) the development, manufacture, marketing and/or sale of the Product by MIP, its Affiliates or sublicensees. MIP shall choose legal counsel, shall control the defense of such claim or action and shall have the right to settle same on such terms and conditions it deems advisable. 11. LIMITATION OF DAMAGES. Neither Party nor their respective Affiliates shall have any liability for any special, incidental or consequential damages, including but not limited to loss of opportunity, revenue or profit, in connection with or arising out of this Agreement, even if it shall have been advised of the possibility of such damages. 12. NOTICES. All notices shall be in writing mailed via certified mail, return receipt requested, courier, or facsimile or other e-mail transmission addressed as follows, or to such other address as may be designated from time to time: IF TO MIP: Molecular Insight Pharmaceuticals, Inc. 160 Second Street Cambridge, Massachusetts 02142 Attn: Vice President, Commercial and Business Development WITH COPY TO: Joshua A. Kalkstein, Esq. Robinson & Cole LLP 12 One Boston Place Boston, MA 02108 IF TO MALLINCKRODT: Mallinckrodt Inc. 675 McDonnell Blvd. St. Louis, MO 63134 Attn: President, Imaging Division WITH COPY TO: Mallinckrodt Inc. 675 McDonnell Blvd. St. Louis, MO 63134 Attn: Vice President Legal, Imaging Division Notices shall be deemed given as of the date received. 13. GOVERNING LAW. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware without giving effect to the principles of conflicts of laws thereof or any other law that would apply the law of another jurisdiction. 14. MISCELLANEOUS. 14.1 BINDING EFFECT. This Agreement shall be binding upon and inure to the benefit of the Parties and their respective legal representatives, heirs, successors and permitted assigns. 14.2 HEADINGS. Paragraph headings are inserted for convenience of reference only and do not form a part of this Agreement. 14.3 COUNTERPARTS. This Agreement may be executed simultaneously in two or more counterparts, each of which shall be deemed an original. Signatures may be transmitted via facsimile, thereby constituting the valid signature and delivery of this Agreement. 14.4 AMENDMENT; WAIVER; ETC. This Agreement may be amended, modified, superseded or cancelled, and any of the terms may be waived, only by a written instrument executed by each Party or, in the case of waiver, by the Party or Parties waiving compliance. The delay or failure of any Party at any time or times to require performance of any provisions shall in no manner affect the rights at a later time to enforce the same. No waiver by any Party 13 of any condition or of the breach of any term contained in this Agreement, whether by conduct, or otherwise, in any one or more instances, shall be deemed to be, or considered as, a further or continuing waiver of any such condition or of the breach of such term or any other term of this Agreement. 14.5 NO THIRD PARTY BENEFICIARIES. No Third Party including any employee of any Party to this Agreement, shall have or acquire any rights by reason of this Agreement. Nothing contained in this Agreement shall be deemed to constitute the Parties as partners with each other or any Third Party. 14.6 ASSIGNMENT AND SUCCESSORS. MALLINCKRODT may not assign its Technology transfer obligations under this Agreement to any Third Party without MIP's consent, which will not be unreasonably withheld, other than to an Affiliate, any purchaser of all or substantially all of MALLINCKRODT's assets, or to any successor corporation resulting from any merger or consolidation of MALLINCKRODT with or into such corporation. MIP may not transfer or assign any of its rights or obligations under this Agreement without the express, prior written consent of MALLINCKRODT, which MALLINCKRODT may withhold in its sole discretion in the event the proposed assignee is a MALLINCKRODT competitor as listed on Exhibit G hereto. With respect to any other assignee (i.e., an assignee not listed on Exhibit G), MALLINCKRODT will not unreasonably withhold its consent to the proposed transfer or assignment. Any attempted assignment or transfer in contravention of this Section shall, at the option of the non-assigning Party, be null and void and of no effect. No assignment shall release either Party from responsibility for the performance of any accrued obligation of such Party hereunder. 14.7 FORCE MAJEURE. Neither MIP nor MALLINCKRODT shall be liable for failure of or delay in performing obligations (other than payment obligations) set forth in this Agreement, and neither shall be deemed in breach of its obligations, if such failure or delay is due to natural disasters or any causes reasonably beyond the control of MIP or MALLINCKRODT. 14.8 SEVERABILITY. If any provision of this Agreement is or becomes invalid or is ruled invalid by any court of competent jurisdiction or is deemed unenforceable, it is the intention of the Parties that the remainder of the Agreement shall not be affected so long as the essential benefits of this Agreement remains enforceable and obtainable. 14 IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the date first above written. MOLECULAR INSIGHT MALLINCKRODT INC. PHARMACEUTICALS, INC. By: /s/ David Barlow By: /s/ Steve Hanley --------------------------------- ------------------------------------ David Barlow Steve Hanley Title: ----------------------------- Title: --------------------------------- Chairman and CEO, Molecular President, Imaging Division Insight Pharmaceuticals, Inc. Date: December 19, 2006 Date: 12/20/06 ------------------------------- ----------------------------------- 15 EXHIBIT A US 5,384,113 EP 600 992B1 AT 196428T BE 600 992 CH 600 992 DE 692231469T DK 600 992 ES 2150916T FR 600 992 GB 600 992 GR 3035067T IT 600 992 LU 600 992 NL 600 992 SE 600 992 CA 2113995C JP 6510539T 16 EXHIBIT B Below are the services to be provided by MALLINCKRODT for the transfer of the Technology for the Vials and the Product to MIP. The objective of this technology transfer is for MALLINCKRODT to provide MIP with sufficient information and training to enable MIP to manufacture and quality control the Vials and the Product. A timeline of activities described below appears in EXHIBIT E. B.1. Documentation for Vials (OctreoTher Reaction Vial) and Product (OctreoTher Hot Liquid) The following documents will be provided by MALLINCKRODT to MIP at least 10 business days prior to the commencement of the Transfer of Technology as described in Section 2.3, unless otherwise agreed upon by MALLINCKRODT and MIP: - R&D Reports as per Table 1, in English and in both hard copy and electronic pdf document format. - Standard Operating Procedures as per Table 2, in the original Dutch and in English and in both hard copy and electronic Word document format. - Regulatory Information Documents as per Table 3, in English and in both hard copy and electronic Word document format. - Documents pertaining to the lyophilization process or the equipment necessary for the manufacturing and quality control of the Vials and the Product as per Table 4, in English or in Dutch and in either hard copy or electronic format. - In addition to the items listed in Tables 1, 2, 3 and 4, MALLINCKRODT will provide to MIP any additional documents identified during the Transfer of Technology that already exist and are readily available to MALLINCKRODT, are required for the manufacturing and quality control of the Vials and the Product, and are requested by MIP. 17 TABLE 1. R&D REPORTS

18 26 Integrity testing of container/closure system to be used in the Octreother hot liquid production 17MJO99R 27 DETERMINATION OF EXCIPIENTS IN REACTION VIALS FOR OCTREOTHER VALIDATION OF THE METHOD Addendum 19MJO00R 28 OCTREOTHER CONSISTENCY RUNS OF ADAPTED PRODUCTION PROCESS. MICROBIOLOGICAL DATA 24WGO00R 29 Preliminary Stability Results SMT487 (90Y) Liquid 27mjo97r 30 Radiochemical Purity Determination of OctreoTher Using Different Integration Events 32MJ099R 31 OCTREOTHER FORMULATION REPORT 5061/14/1996 32 DEVELOPMENT OF OCTREOTHER-90 KIT 5061/15/1995 33 DOTA-TYR3-OCTREOTIDE ASSAY BY HPLC. VALIDATION OF METHOD 5061/21/1996 34 RADIOCHEMICAL PURITY OF 90Y-DOTA-TYR3-OCTREOTIDE. VALIDATION OF THE METHOD 5061/22/1996 35 INCORPORATION OF 90Y-DOTA-TYR3-OCTREOTIDE VALIDATION OF THE METHOD 5061/24/1996 36 STABILITY 90Y-SMT487 FOR HOT-TOXICITY STUDY 07MJO97R 37 Quality testing of Yttrium (90Y) chloride by means of incorporation assay into DOTA-Tyr3-Octreotide 12mjo02R 38 Influence of the Alltech 1.0 ml Minivial 20/4000 on the incorporation capability of Y-90 to SMT 487 peptide 18ewe03r 39 Close out report B220X project, validation status of OctreoTher facility ###-###-#### 40 Extension of the OctreoTher production Memo to File, E. van Wensveen 41 Identification of Impurities in gentisic acid and peroxide cured silicon tubing 13MJO02R 42 Air-tightness testing mepal container for Yttrium-OctreoTher solution shipments ###-###-#### 43 testing box 33 Multipack containing Yttrium-OctreoTher solution ###-###-####

19 TABLE 2. STANDARD OPERATING PROCEDURES
Title document code - -------------- -------- Octreother D3-03925 Reactionmixture for Octreother bulk D6-03925 Reactiemixture for Octreother D7-03925 Dispensing set, solutions and dilutions, 10 - 25 ml, sterilized E2-10504 Fiterset, Millipak 60, sterilized E2-10561 tubingset Octreother, cel 0902.000 Compudil A, sterilized E2-11326 tubingset Octreother, cel 0902.000 diluter, sterilized E2-11328 tubingset Octreother, cel 0903.000, sterilized E2-11331 Filter, Pall, NOVASIP, C2PFRP1, E2-11375 Tubingset, diluter Octreother, 3 flasks, sterilized E2-11407 tubingset, verdunner Octreother, sterilized E2-11412 Pumping set Octreother, cel 0903.000 E2-11413 Needle, pencilpoint, diam 1,2mm E2-11418 Z-needle, pencilpoint, lengte 20x20x78mm E2-11419 Curved needle, pencilpoint, diam 1,2mm, lengte 20x54mm E2-11421 Tubing set, bulkfluidreactionmixture, sterile E2-11441 Curved needle,pencilpoint, diam 1,2 mm, lengte 20x87 mm E2-11445 Curved needle,pencilpoint, diam 1,2 mm, lengte 28x57 mm E2-11446 Z-needle, pencilpoint, 20x20x78mm, passivated E2-11447 Curved needle, pencilpoint, 20x54mm, passivated E2-11448 Curved needle,pencilpoint, diam 1,2 mm, lengte 20x50 mm E2-11449 Dispensing set, sofiumchloride for octreother, gesteriliseerd E2-11450 Curved needle, pencilpoint, 28x57mm, gepassiveerd E2-11456 Curved needle, pencilpoint, 20x87mm, gepassiveerd E2-11457 Dispensing set Octreother forunit cel 0903.000, gesteriliseerd E2-11467 Filterset A Millipak 60, Pt-netted tubing E2-11490 filterset B Millipak 60, Pt-netted tubing E2-11491 Dispensing set, Pt-netted tubing E2-11492 dispensingset, Pt-netted tubing E2-11492 flask 2, assembleerd, Millipak 60, Pt-netted tubing E2-11493 flask 2, assembleerd, Millipak 60, Pt-netted tubing E2-11493 Dispensing set for kits, Pt-netted tubing E2-12007 Lyophilization vial 10 ml, stopper FM157, clean E2-12198 Wing needle, diam 2,0mm, lengte 20x280mm E2-12336 transportcontainer Octreother E3-11472 Certificate of analysis: Octreother E4-11335 SPC Yttrium (Y90) SMT487, i.v. E4-11373 Rubberstopper E6-10030 Rubberstopper N6-10856 Water for injecties, in bulk E5-10114 Purified water E5-12300 Materials for the productie of octreother E5-11408 Lyophilization vial 10 ml, E6-10009 Lyophilization stopper, DIAM 20 mm, FM157, E6-10018 vial 100 ml, clean gesteriliseerd E6-11303 vial 100ml, filled with nitrogen E6-11304 Rubberstop, diam 32 mm, FM257, clean, sterile E6-11308 Needleprotector, rubber, 14 mm E6-11394 Elution needle protector E6-10130 Octreother F3-03925 Reactiemixture for octreother, bulk F6-03925
20 TABLE 2. STANDARD OPERATING PROCEDURES
Title document code - -------------- -------- Reactiemixture for voor Octreother F7-03925 ring glassvial Octreother-Lab G0-00095 ring Nensure P-2 flacon Octreotherlab G0-00102 ring 10 ml lyophilization vial Octreotherlab G0-00105 ring for 100 ml flacon octreotherlab G0-00114 Testset for visual inspection of vials in octreotherlab en radiopharmacy G0-00147 Vial 500 ml Vacuum steriel N1-12015 Tubing, siliconubber, diam 6,0 x 10,0 mm N2-10044 Tubing, siliconrubber, diam 4,0x7,0mm N2-10459 Tubing, siliconrubber, diam 4,0 x 7,0 mm N2-10459 Tubing, siliconrubber, diam 1,0x3,0mm N2-10460 Filter millex N2-10825 Tubing, siliconrubber, diam 4,0 x 10,0 mm N2-10462 Injection needle 18G, lengte 19 mm N2-10561 Filter millipore, millipak 60 MPGL 06GH2 N2-10811 Filter hydrofoob ACRO 50 N2-10826 Vail 250 ml N2-11429 Tubing, siliconrubber, 1,6 x 6,4 mm N2-11435 Tubing, siliconrubber, 3,2 x 8,0 mm N2-11436 Tubing 1,02 mm, diam 2,69 mm, lengte 3 m N2-11476 Filter, Whatman, Polycap 36 SPF N2-11508 Double tubingsett, 3,2 mm N2-11515 Double tubingset, 4,8 mm N2-11516 Curved needle, diam 0,9 x 1,2 mm, lengte 20 x 200 mm N2-11595 Threeway valve N2-11730 Tubing, siliconrubber, 2,38 x 4,0 mm N2-11743 Tubing siliconrubber, 2,29x0,85x900mm N2-11744 capsule, diam 32,5 mm, N2-11745 Filter, Pall, Novasip, C2PFRP1 N2-11775 Tubing, siliconrubber, diam. 1,6 x 4,8 mm N2-11785 Vial 500ml N2-11820 dispensingset octreother, cel 0903.000 N2-11852 Filter, Millex 0,22 ugm, SLGP 033 RS N2-11855 Tubing, siliconrubber, diam 4,8 x 9,6 mm N2-11858 Tubing, siliconrubber, diam 6,4 x 9,6 mm N2-11859 Syringe N2-11925 Tubing, PTFE, capilaire tubing N2-11926 Wing needle, 18G x 1,5 N2-11927 Syringe 1 ml luerlock H804 N2-12035 Neo labbinders N2-12041 Tubing siliconenrubber 10 x 14 N2-12075 T-piece Diam, 6 MM P.P. N2-12081 Filter Millex SLFG 025 LS N2-12098 Connector Luer 0,8 female N2-12111 Connector Luer 1.6 male N2-12112 Connector luer 0,8 male N2-12113 Connector Luer 1,6 female N2-12115 Connector luer 3.2 Female N2-12117 Connector Luer 3.2 MALE N2-12118 Naald vleugel/beluchting 1.6 MM N2-12119 T-part, polupropylene N2-11915 Beaker, plastic N3-11854
21 TABLE 2. STANDARD OPERATING PROCEDURES
Title document code - -------------- -------- Demineralized water N5-70362 Ascorbic acid N5-70001 sodiumhydroxide, N5-70016 nitrogenf 99,98 % fluid N5-70120 GENTISIc acid N5-70128 Inositol N5-70135 Water forr injections in vial, 1000 ml N5-70261 sodiumchloride-solution 0,9% in vial 1000 ml N5-70267 DOTA-TYR3-octreotide N5-70415 Connector N6-10158 lyophilizationstopper diam 20mm grey FM157 N6-10159 Needle, Z-vormig UTK N6-10177 Venapunction needle N6-10179 Lyophilization vial 10 ml N6-10217 Needle steel 316, diam 0,83x1,2mm, lengte 173mm N6-10247 Elution needle protector N6-10006 vail 100 ml, N6-11736 Rubberstopper, diam 32 mm, , FM257 N6-11737 capsule, aluminium, diam 20 mm N6-11884 capsule, diam 32,5 mm, N6-11887 Yttrium chloride (Y90) N7-70429 Needle N6-10248 Tubing set P5-11407 dispensinglset, solutions, 10 - 25 ml, gesteriliseerd P2-10504 Filterrset, Millipak 60, gesteriliseerd P2-10561 tubingset Octreother, cel 0902.000, Compudil A, gesteriliseerd P2-11326 tubingset Octreother, cel 0902.000, diluter, gesteriliseerd P2-11328 tubingset Octreother, cel 0903.000, gesteriliseerd P2-11331 tubingset, diluter octreother, 3 flasks, gesteriliseerd P2-11407 Tubingset diluetr octreother, gesteriliseerd P2-11412 Pumptubingset octreother, cel 0903.000 P2-11413 tubingset, bulk reactionmixture octreother, gesteriliseerd P2-11441 Z-needle, pencilpoint, 20x20x78mm, gepassiveerd P2-11447 Curved needle, pencilpoint, 20x54mm, gepassiveerd P2-11448 dispensingset sodiumchloride for octreother gesteriliseerd P2-11450 Curved needle, pencilpoint, 28x57mm, gepassiveerd P2-11456 Curved needle, pencilpoint, 20x87mm, gepassiveerd P2-11457 Materials for the production of octreother P5-11408 Lyophilization stopper, DIAM 20 mm, FM157,sterilized P6-10018 vial 100ml filled with nitrogen P6-11304 Rubberstop, diam 32 mm, , FM257, P6-11308 Visual inspection of octreother vials W0-10364 Procedure to calculate the yttrium-90 amount to order W0-10436 Measurement of radioactivity with an ionisatiecahmber with picoammeter W1-10001
22 TABLE 3. REGULATORY INFORMATION DOCUMENTS
Number Title - ------ ----- ~~1 Yttrium (90Y) SMT 487 Clinical Trial Application Information Chemical and Pharmaceutical Data 2 Yttrium (90Y) SMT 487 IND Information Manufacturing Description~~
23 TABLE 4. ADDITIONAL DOCUMENTS
Number Title - ------ ----- 1 Description of the lyophilization process 2 Description of the equipment used in the manufacturing process for the Product 3 Description of the Quality Control equipment used in the quality control methods of the Vials 4 Description of the Quality Control equipment used in the quality controls methods of the Product
24 B.2. Manufacture and Quality Control of the Vials (OctreoTher Reaction Vial) Prior to commencing the manufacturing and quality control technology transfer at the Petten Facility, MIP personnel must successfully complete Laboratory and Radiation Safety Training conducted by Safety Personnel at the MALLINCKRODT Petten site. B.2.1. Manufacturing of the Vials MALLINCKRODT personnel will describe and demonstrate to MIP personnel the manufacturing process for the OctreoTher Reaction Vial consistent with or equivalent to GMPs at the MALLINCKRODT facility in Petten, The Netherlands. The following services will be provided: - a review of the Process Flow Sheet describing the manufacturing, ingredients, and materials needed in the manufacturing process; - a review of the packaging; - one demonstration of the preparation of the matrix solution, without the addition of the peptide SMT 487, by MALLINCKRODT personnel during the initial visit to Petten by MIP personnel. MIP has the right to request that MALLINCKRODT personnel perform one additional demonstration of the preparation of the matrix solution, without the addition of the peptide SMT 487, at a date and site to be determined after the initial visit to Petten by MIP personnel. In the event that this additional demonstration occurs, MIP shall pay MALLINKRODT'S expenses pursuant to Section 2.3; - at least one but not more than two preparations of the matrix solution by MIP personnel with MALLINCKRODT personnel supervision during the initial visit to Petten by MIP personnel. MIP has the right to perform at least one but not more than two preparations of the matrix solution by MIP personnel with MALLINCKRODT 25 personnel supervision at a date and site to be determined after the initial visit to Petten by MIP personnel. In the event that such additional activities occur, MIP shall pay MALLINKRODT'S expenses pursuant to Section 2.3; - the parameters for the lyophilization cycle; - discussion of the documents provided in Tables 1, 2, and 3 as they pertain to the OctreoTher Reaction Vial manufacturing, such as product specifications, batch records, stability studies, fill-finish, and the lyophilization cycle. B.2.2. Quality Control of Vials MALLINCKRODT personnel will describe and demonstrate to MIP personnel the quality control (QC) methods for the OctreoTher Reaction Vial consistent with or equivalent to GMPs at the MALLINCKRODT facility in Petten, The Netherlands. OctreoTher Reaction Vials from lot number 220930 will be used for this testing. The following services will be provided: - one demonstration of the QC methods for the ingredients by MALLINCKRODT personnel during the initial visit to Petten by MIP personnel. MIP has the right to request that MALLINCKRODT personnel perform one additional demonstration of the QC methods at a date and site to be determined after the initial visit to Petten by MIP personnel. In the event that this additional demonstration occurs, MIP shall pay MALLINKRODT'S expenses pursuant to Section 2.3; - one demonstration of in-process testing by MALLINCKRODT personnel during the initial visit to Petten by MIP personnel. MIP has the right to request that MALLINCKRODT personnel perform one additional demonstration of in-process testing at a date and site to be determined after the initial visit to Petten by MIP personnel. In the event that this additional demonstration occurs, MIP shall pay MALLINKRODT'S expenses pursuant to Section 2.3; 26 - one demonstration of the QC methods for the Vial by MALLINCKRODT personnel during the initial visit to Petten by MIP personnel. MIP has the right to request that MALLINCKRODT personnel perform one additional demonstration of the QC methods for the Vial at a date and site to be determined after the initial visit to Petten by MIP personnel. In the event that this additional demonstration occurs, MIP shall pay MALLINKRODT'S expenses pursuant to Section 2.3; - at least one but not more than two completions by MIP personnel of the QC methods for the ingredients, in-process testing, and the Vial with MALLINCKRODT personnel supervision during the initial visit to Petten by MIP personnel. MIP has the right to perform at least one but not more than two completions of the QC methods for the ingredients, in-process testing, and the Vial with MALLINCKRODT personnel supervision at a date and site to be determined after the initial visit to Petten by MIP personnel. In the event that such additional activities occur, MIP shall pay MALLINKRODT'S expenses pursuant to Section 2.3; - discussion of the documents provided in Tables 1, 2, and 3 as they pertain to OctreoTher Reaction Vial quality control. B.3. Manufacture and Quality Control of the Product (OctreoTher Hot Liquid) B.3.1. Manufacturing of the Product MALLINCKRODT personnel will describe and demonstrate to MIP personnel the manufacturing process for the Product consistent with or equivalent to GMPs at the MALLINCKRODT facility in Petten, The Netherlands. OctreoTher Reaction Vials from lot number 220930 will be used for the manufacturing of the Product. The following services will be provided: 27 - a review of the Process Flow Sheet describing the manufacturing, ingredients, and materials needed in the manufacturing process; - a review of the packaging; - one demonstration of the preparation of the OctreoTher Hot Liquid without Y-90 by MALLINCKRODT personnel during the initial visit to Petten by MIP personnel. MIP has the right to request that MALLINCKRODT personnel perform one demonstration of the OctreoTher Hot Liquid without Y-90 at a date and site to be determined after the initial visit to Petten by MIP personnel. In the event that this additional demonstration occurs, MIP shall pay MALLINKRODT'S expenses pursuant to Section 2.3; - one demonstration of the preparation of the OctreoTher Hot Liquid with Y-90 by MALLINCKRODT personnel during the initial visit to Petten by MIP personnel. MIP has the right to request that MALLINCKRODT personnel perform one additional demonstration of the OctreoTher Hot Liquid with Y-90 at a date and site to be determined after the initial visit to Petten by MIP personnel. In the event that this additional demonstrations occur, MIP shall pay MALLINKRODT'S expenses pursuant to Section 2.3; - one preparation of the OctreoTher Hot Liquid without Y-90 by MIP personnel with MALLINCKRODT personnel supervision during the initial visit to Petten by MIP personnel. MIP has the right to perform one preparation of the OctreoTher Hot Liquid without Y-90 by MIP personnel with MALLINCKRODT personnel supervision at a date and site to be determined after the initial visit to Petten by MIP personnel. In the event that such additional activities occur, MIP shall pay MALLINKRODT'S expenses pursuant to Section 2.3; 28 - one preparation of the OctreoTher Hot Liquid with Y-90 by MIP personnel with MALLINCKRODT personnel supervision during the initial visit to Petten by MIP personnel. MIP has the right to perform one preparation of the OctreoTher Hot Liquid with Y-90 by MIP personnel with MALLINCKRODT personnel supervision at a date and site to be determined after the initial visit to Petten by MIP personnel. In the event that such additional demonstrations occur, MIP shall pay MALLINKRODT'S expenses pursuant to Section 2.3; - discussion of the documents provided in Tables 1, 2, and 3 as they pertain to the OctreoTher Hot Liquid manufacturing, such as product specifications, batch records, and stability studies. B.3.2. Quality Control of Product MALLINCKRODT personnel will describe and demonstrate to MIP personnel the quality control (QC) methods for the OctreoTher Hot Liquid consistent with or equivalent to GMPs at the MALLINCKRODT facility in Petten, The Netherlands. The following services will be provided: - one demonstration of in-process testing by MALLINCKRODT personnel during the initial visit to Petten by MIP personnel. MIP has the right to request that MALLINCKRODT personnel perform one additional demonstration of in-process testing at a date and site to be determined after the initial visit to Petten by MIP personnel. In the event that this additional demonstration occurs, MIP shall pay MALLINKRODT'S expenses pursuant to Section 2.3; - one demonstration of the QC methods for the Product by MALLINCKRODT personnel, preferably on the Product manufactured by MALLINCKRODT in Section B.3.1 during the initial visit to Petten by MIP personnel. MIP has the right to request 29 that MALLINCKRODT personnel perform one additional demonstration of the QC methods for the Product at a date and site to be determined after the initial visit to Petten by MIP personnel. In the event that this additional demonstration occurs, MIP shall pay MALLINKRODT'S expenses pursuant to Section 2.3; - at least one but not more than two completions by MIP personnel of the QC methods for in-process testing and the Product, preferably on the Product produced by MIP in Section B.3.1, with MALLINCKRODT personnel supervision during the initial visit to Petten by MIP personnel. MIP has the right to perform at least one but not more than two completions by MIP personnel of the QC methods for in-process testing and the Product with MALLINCKRODT personnel supervision at a date and site to be determined after the initial visit to Petten by MIP personnel. In the event that such additional activities occur, MIP shall pay MALLINKRODT'S expenses pursuant to Section 2.3; - discussion of the documents provided in Tables 1, 2, and 3 as they pertain to OctreoTher Hot Liquid quality control. B.4. Response to Inquires Concerning the Technology MALLINCKRODT personnel will be available to provide responses or clarification to inquiries from MIP concerning the Technology during the course of the transfer of the Technology as described in Section 2.3. B.5. Equivalency Testing of the Product (OctreoTher Hot Liquid) MALLINCKRODT and MIP personnel will conduct equivalency testing on the OctreoTher Hot Liquid. Equivalency testing will consist of MALLINCKRODT and MIP independently conducting quality control (QC) testing of the Product as defined by the specifications in Section 30 5.3.1 of the Yttrium ((90)Y) SMT 487 IND Information Manufacturing Description attached to this Agreement as EXHIBIT F. The OctreoTher Hot Liquid will be manufactured consistent with or equivalent to GMPs by either MALLINCKRODT or MIP as specified below. The following services will be provided: - MALLINCKRODT will prepare one manufacturing preparation of the OctreoTher Hot Liquid sufficient to provide finished Product for QC testing by both MALLINCKRODT and MIP; - MALLINCKRODT will ship to MIP the required vials of Product necessary to perform the QC testing; - On the same date, MALLINCKRODT and MIP will independently perform the QC tests and MALLINCKRODT will inform MIP of its results. - MALLINCKRODT will receive from MIP one but not more than two manufacturing preparations of the OctreoTher Hot Liquid manufactured by MIP; - On the same date, MALLINCKRODT and MIP will independently perform the QC tests and MALLINCKRODT will inform MIP of its results. 31 EXHIBIT C CERTIFICATION OF COMPLETION OF TECHNOLOGY TRANSFER MALLINCKRODT INC. hereby certifies that it has completed its Technology transfer obligations under that certain Agreement, dated as of ____________, 2006, between MALLINCKRODT INC. and MOLECULAR INSIGHT PHARMACEUTICALS, INC. MALLINCKRODT INC. By: --------------------------------- Title: ------------------------------ Date: ------------------------------- 32 EXHIBIT D Specifications for the OctreoTher SMT 487 Reaction Vial are as follows:
TEST LIMIT ---- ----- Appearance clear and no visual impurities pH 4.0 - 5.0 Sterility sterile Endotoxins < or = 20 eu/vial ascorbic acid 64.0 - 78.2 mg/vial inositol 36.0 - 44.0 mg/vial radiochemical purity, 15 min > or = 90% Radiochemical purity, 6 h > or = 90% (90)Y-Incorporation > or = 99.5% SMT 487 72.0 - 88.0 ug/vial Uniformity SMT 487 content 10 vials within 85 - 115% (n=10) or < or = 1 of 30 out of 85 - 115%, but all within 75 - 125% gentisic acid 14.4 - 17.6 mg/vial water content < or = 5% identity comply with test
33 EXHIBIT E The overall work plan and timeline for the Transfer of Technology is as follows:
Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Days Days Days Days Days Days TASK NAME 1 - 30 31 - 60 61 - 90 91 - 120 121 - 150 151 - 180 - --------- ------- ------- ------- -------- --------- --------- CONTRACT EXECUTION Mallinckrodt & MIP Execute Contract Mallinckrodt Receives Initial Payment at Contract Execution Mallinckrodt Invoices MIP and Receives 50% Payment for OctreoTher Vials Mallinckrodt Initiates SOP Translation per MIP Instructions COMMENCEMENT OF TECHNOLOGY TRANSFER Mallinckrodt Transmits R&D and Regulatory Documents to MIP Mallinckrodt Transmits First Set of Translated SOPs to MIP Mallinckrodt Invoices MIP for Payment due upon Commencement of Technology transfer Mallinckrodt Ships OctreoTher Vials to MIP per Their Instructions Mallinckrodt Invoices MIP for Remaining 50% Payment due for OctreoTher Vials Mallinckrodt Receives Above Two Payments Prior to On-Site Technology Transfer TRANSFER OF TECHNOLOGY AT MALLINCKRODT PETTEN FACILITY Mallinckrodt Provides Services per Exhibit B MALLINCKRODT TECHNICAL AVAILABILITY Mallinckrodt Provides Services per Exhibit B TRANSFER OF TECHNOLOGY AT MIP DESIGNATED FACILITY (IF REQUESTED) Mallinckrodt Provides Services per Exhibit B EQUIVALENCY TESTING Mallinckrodt Provides Services per Exhibit B TECHNOLOGY TRANSFER COMPLETION Mallinckrodt Sign-Off of Certificate of Completion Mallinckrodt Invoices for and Receives Payment for Completion of Technology Transfer
34 EXHIBIT F Specifications for Yttrium (90Y) SMT 487 (OctreoTher Hot Liquid) are as follows:
TEST LIMIT ---- ----- Appearance Clear, colourless, or slightly yellow solution (90)Y-Incorporation > or = 99.3% Radiochemical purity > or = 90% Radioactive concentration 51.6 Bq/ml +/- 10% (1.4 mCi/ml +/- 10%) pH 4.0 - 5.0 Endotoxins < or = 0.2 eu/vial (parametric release) sterility sterile (parametric release)
35 EXHIBIT G Below is a list of MALLINCKRODT competitors. Bracco Bristol-Myers Squibb Cardinal Health, Inc. GE Healthcare Division of the General Electric Company Schering AG 36