EX-10.1: AMENDED DISTRIBUTION AGREEMENT

Exhibit 10.1

AMENDMENT AGREEMENT

to the

DISTRIBUTION AGREEMENT
dated April 3, 1998

by and between

CENTOCOR, INC.,

CNA DEVELOPMENT, LLC
(as licensee to Centocor, Inc.’s worldwide rights to Golimumab Product),

and

SCHERING-PLOUGH (IRELAND) COMPANY
(as successor in interest to Schering-Plough Ltd.)

DECEMBER 20, 2007

     Portions of this exhibit have been omitted and filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. Omissions are designated as [* *] .

AMENDMENT AGREEMENT

     This Amendment Agreement (hereinafter the “Amendment Agreement”), dated as of December 20, 2007 (the “ Amendment Date ”), is made by and between Centocor, Inc. a corporation organized under the laws of Pennsylvania with its principal office at 800 Ridgeview Drive, Horsham, Pennsylvania (“ Centocor ”), CNA Development, LLC, a limited liability company organized under the laws of Delaware (“ CNA Development ”, and collectively with Centocor, the “ Centocor Parties ”); and Schering-Plough (Ireland) Company, a corporation organized under the laws of Ireland, with offices at Rathdrum, County Wicklow, Ireland (“ Schering-Plough ”) (Schering-Plough and the Centocor Parties, each referred to from time to time herein as a “ Party ” and collectively as the “ Parties ”). To the extent set forth herein, this Amendment Agreement modifies and amends the Distribution Agreement referenced below.

RECITALS

     WHEREAS, on April, 3, 1998, Centocor and Schering-Plough Ltd., a corporation organized under the laws Switzerland with its principal offices at Weystrasse 20, CH 6000 Lucerne, Switzerland (“SPL”) entered into a Distribution Agreement, as previously amended (the “ Distribution Agreement ”) and SPL subsequently assigned the Distribution Agreement to its Affiliate, Schering-Plough, under the terms of that certain Assignment and Assumption Agreement, dated August 25, 2005; and

     WHEREAS, pursuant to the terms of the Distribution Agreement the Parties and their respective Affiliates have been developing and commercializing the chimeric anti-TNF monoclonal antibody Product (known as cA2 or infliximab) in the Territory under the Trademark REMICADE (the “ Remicade Product ”); and

     WHEREAS Centocor has developed a fully human anti-TNF monoclonal antibody product known as golimumab (the “ Golimumab Product ”) through Phase IIb clinical trials and, prior to the exercise by Schering-Plough of its rights under Section 12.1 of the Distribution Agreement to participate in the continued development and commercialization of the Golimumab Product as a Product under the Distribution Agreement (the “ Golimumab Option ”), Centocor licensed the worldwide rights to Golimumab Product, subject to the Golimumab Option, to its Affiliate, CNA Development; and

     WHEREAS Schering-Plough has exercised its Golimumab Option rights and Schering-Plough and Centocor subsequently arbitrated a disagreement over the duration of Schering-Plough’s rights to the Golimumab Product under the Distribution Agreement resulting in a final decision by the arbitrator that the term of Schering-Plough’s rights to the Golimumab Product under the Distribution Agreement will continue for a period of fifteen years from the date of first Commercial Sale of Golimumab Product in the Territory; and

     WHEREAS Centocor has appealed the decision of the arbitrator and Centocor and Schering-Plough have recently engaged in good faith discussions in an attempt to settle and finally resolve their dispute over the term of Schering-Plough’s rights to Golimumab Product as well as to resolve certain additional outstanding issues related to the development and commercialization of Remicade Product and/or Golimumab Product under the terms of the Distribution Agreement, and now desire to document their mutual agreement on all such matters, as set forth in detail herein; and

     WHEREAS Centocor has therefore agreed to terminate and permanently withdraw its appeal of the aforementioned arbitrator’s decision in conjunction herewith and as provided herein; and

     WHEREAS CNA Development is also in agreement with all of the amendments and modifications to the Distribution Agreement set forth herein pertaining to the Golimumab Product;

     NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the Parties hereby agree as follows:

     Except as otherwise expressly set forth in this Amendment Agreement, the capitalized terms used herein (whether in the singular or plural) shall have the respective meanings set forth in the Distribution Agreement.

ARTICLE 1
DISTRIBUTION AGREEMENT AMENDMENTS, CLARIFICATIONS AND MODIFICATIONS

     The following amendments, clarifications and modifications to the Distribution Agreement shall become effective immediately upon execution of this Amendment Agreement:

     1.1 Clarification of Product Definition . The definition of Product shall include, without limitation, the Remicade Product and the Golimumab Product, as well as any Improvements to either such Product. However, for clarity, the occurrence of the term “Product” in the first sentence of the second whereas clause of the Distribution Agreement and in the proviso to the “Cost of Goods Sold” definition shall be deemed to refer to Remicade Product only, and all references in the Distribution Agreement to the “Product” as being “described” or “set forth” in Appendix A to that agreement shall be deemed to be references to the relevant Product as described in the revised Appendix A attached hereto. In addition, the various references to “Trademark” in Section 4.3(b) of the Distribution Agreement, when used in connection with the term “Product”, shall be deemed to refer to the relevant Trademark for each of Remicade Product and Golimumab Product, respectively, it being understood that the Product Committee shall be responsible for agreeing upon the Trademark(s) to be used for Golimumab Product in the Territory. The Parties also agree that the references to “Product” appearing in third paragraph of Section 5.1 of the Distribution Agreement shall be deemed to only refer to Remicade Product and that the “Manufacture and Supply

Agreement” referred to in that paragraph is the Remicade Supply Agreement (as defined below).

     1.2 Affiliate Definition; Delegation and Assignment. The last sentence of the definition of “Affiliate” (i.e., the sentence: “Any reference in this Agreement to Centocor or Schering-Plough includes the Affiliates of that Party unless the context clearly indicates to the contrary.”) is hereby deleted. Notwithstanding such deletion, and consistent with Section 12.8 of the Distribution Agreement, it is understood and agreed that each Party may license and/or delegate or assign any rights and the performance of any of its obligations under the Distribution Agreement to an Affiliate without the prior consent of the other Party.

     1.3 Affiliate-Controlled IP . The Parties acknowledge that either Party may from time to time during the Term propose that proprietary technology, materials, processes, know-how, data, information, patent rights and/or other intellectual property rights that are owned or controlled by an Affiliate of such Party (“ Affiliate-Controlled IP ”) be utilized by the Parties in the development, manufacture and/or commercialization of one or more Products in the Territory. Centocor is under no obligation to agree to any such proposal by Schering-Plough. It is further understood that any use of Affiliate-Controlled IP (i) shall be subject to the prior approval requirement in Section 6.2(a)(i) of the Distribution Agreement if it would result in obligations to directly or indirectly pay license fees, milestones, royalties or other payments to one or more unaffiliated third parties in the case of any Centocor Affliliate-Controlled IP and (ii) shall be subject to a comparable prior consent requirement in the case of any Schering-Plough Affiliate-Controlled IP. The Parties further agree that the Party making available such Affiliate-Controlled IP to the other Party shall not charge or require reimbursement from the other Party (or the other Party’s Affiliates) for, or include in the calculation of Contribution Income, any licensee fees, milestones, royalties or other payments due or payable to its Affiliates as a result of the use of such Affiliate-Controlled IP in connection with development, manufacture and/or commercialization of the Products in the Territory, with the exception of such amounts that are pass through amounts payable by such Affiliate(s) to unaffiliated third party licensors as a result of such use of such Affiliate-Controlled IP. In addition, any costs and expenses previously incurred by or on behalf of such Affiliates in the development of such Affiliate-Controlled IP shall not be included in Product Development Costs unless expressly agreed by the Parties in writing. Nothing in this Section 1.3 shall be construed as (i) granting (whether expressly or by implication) to either Party any licenses or other rights to any Affiliate-Controlled IP that has not, as of the Amendment Date, already been utilized by written agreement of the Parties for the development, manufacture or commercialization of the Products in the Territory, or (ii) obligating either Party to make available any new or additional Affiliate-Controlled IP for such use. For the avoidance of doubt, it is understood that Centocor may (without Schering-Plough’s prior consent) utilize, and grant Schering-Plough the right to utilize, any new or additional Centocor proprietary technology, materials, processes, know-how, data, information, patent rights and/or other intellectual property rights or any Centocor Affiliate-Controlled IP in connection with the development, manufacture and commercialization of Products in the Territory; provided that such utilization does not

result in (x) any requirement for additional consideration or compensation to be paid by Schering-Plough or its Affiliates in connection with such Affiliate-Controlled IP, (y) any development costs associated with such Affiliated-Controlled IP being included as Product Development Costs, or (z) any additional Affiliate or unrelated third party pass-through costs being included in the calculation of Contribution Income.

     1.4 Term of the Distribution Agreement . Section 8.1 of the Distribution Agreement is hereby deleted and replaced in its entirety with the following:

“8.1 Term . The term of this Agreement (the “Term”) shall commence on the Effective Date and continue for a period ending on the later to occur of the last day of the Remicade Term or the Golimumab Term, unless this Agreement is earlier terminated pursuant to the provisions of this Agreement. The foregoing notwithstanding, in the event that prior to the expiration of the Term (as defined above) Schering-Plough acquires rights, pursuant to Section 12.1 of this Agreement, to any additional fully human anti-TNF monoclonal antibodies developed by Centocor through transgenic animals or plants or other technology (an “ Additional Section 12.1 Product ”), then the term of this Agreement shall be extended, solely with respect to such Additional Section 12.1 Product, to expire on the fifteenth anniversary of the date of the first Commercial Sale of such Additional Section 12.1 Product in the European Union after the grant of the first Marketing Approval of such Additional Section 12.1 Product in the European Union.”

     The following new definitions are hereby added to Article 1 of the Distribution Agreement:

“ Remicade Term ” shall mean the period beginning on the Effective Date and ending on September 1, 2014.

“ Golimumab Term ” shall mean the period beginning on the date of the first Commercial Sale of Golimumab Product to occur in the European Union after the grant of the first Marketing Approval of Golimumab Product in the European Union (the “ First Golimumab Commercial Sale ”), and ending upon the fifteenth (15 ^th ) anniversary of such date.

     For clarity, in the event that the Term of the Distribution Agreement is extended due to the acquisition by Schering-Plough of rights to any Additional Section 12.1 Products, any such extension of the Term shall have no effect on the expiration of Schering-Plough’s rights to the Remicade Product or the Golimumab Product, each of which shall still expire and revert to Centocor, respectively, on expiration of the Remicade Term (in the case of Remicade Product) or on expiration of the Golimumab Term (in the case of Golimumab Product).

     1.5 Milestone Payments . The Parties acknowledge and agree that the various payments provided for in Sections 3.1, 3.2 and 3.3 of the Distribution Agreement have been paid with respect to Remicade Product, and that the development and commercialization of Golimumab Product does not and will not give rise to any additional payment obligations under those Sections of the Distribution Agreement.

     1.6 Separate Contribution Income Calculations for Golimumab Product and Remicade Product . For convenience and transparency to product line information, the Parties agree that Contribution Income will be calculated separately for Remicade Product and Golimumab Product based upon the Net Sales of each such Product in the Territory. Nonetheless, for the purpose of clarity, the manner and elements of calculating Contribution Income will be the same for Remicade Product and Golimumab Product, and shall continue to be as set forth in Section 6.2 of the Distribution Agreement and Section 7.1 of the Supply Agreement, dated September 15, 1999, between Centocor and Schering-Plough, as amended (the “ Remicade Supply Agreement ”). For further clarity, the Parties agree that the $150,000,000 Net Sales threshold in Section 6.2(c) shall apply separately to Golimumab Product and to Remicade Product, rather than to the aggregated Product sales, for all periods prior to the Trigger Date (as defined below).

     1.7 Golimumab Costs Prior to the First Golimumab Product Marketing Approval . The Parties acknowledge and agree that, subject to the terms and conditions set forth in this Section 1.7, the Parties shall have the right to include in the Contribution Income calculation any Marketing Expenses and/or sales costs related to the commercialization of Golimumab Product in the Territory that are incurred prior to the first Marketing Approval of Golimumab Product in the Territory (collectively, the “ Pre-Approval Marketing and Sales Costs ”). The total of all Pre-Approval Marketing and Sales Costs incurred for the 2006 and 2007 Agreement Years that are to be included in the Contribution Income calculation for the Products shall be subject to the caps on such amounts set forth in Schedule 1.7 (attached hereto). With respect to the 2008 Agreement Year and any subsequent Agreement Years (or partial Agreement Year) occurring prior to the Trigger Date, the Parties shall be permitted to include in the Contribution Income calculation for the Products in the relevant Agreement Year those Pre-Approval Marketing and Sales Costs that are incurred in such Agreement Year in connection with the performance of the Country Marketing Plans established for Golimumab Product in the Territory. For clarity, the Parties agree that notwithstanding the date on which the first Commercial Sale of Golimumab Product in the Territory occurs, the inclusion of Pre-Approval Marketing and Sales Costs in the calculation of Contribution Income shall become effective on the Amendment Date. The foregoing notwithstanding, to the extent that the aggregate total of all Pre-Approval Marketing and Sales Costs incurred by Schering-Plough over the entire period extending from January 1, 2006 to the Trigger Date exceeds [**]  dollars ($ [**] ) (the “ Pre-Approval Cost-Sharing Cap ”), Schering-Plough shall be solely responsible for all such Pre-Approval Marketing and Sales Costs in excess of the Pre-Approval Cost-Sharing Cap, shall not be entitled to any reimbursement from or cost sharing by Centocor for such excess amounts, and shall not include such excess amounts in the Contribution Income calculation. For clarity, the

costs of any ongoing or future Phase III or Phase IIIb studies for the Golimumab Product shall not be included in determining Pre-Approval Marketing and Sales Costs.

     1.8 Tanabe Rights . Without modifying the provisions of Section 2.3(a) of the Distribution Agreement, the Parties agree that Schering-Plough’s rights in that section will not be triggered in the event that Tanabe Seiyaku Co. Ltd. (“ Tanabe ”), or any of Tanabe’s Affiliates or successors in interest, grants to Centocor or a Centocor Affiliate co-promotion rights, co-marketing rights or other semi-exclusive commercialization rights (e.g., where Tanabe, its Affiliates or successors in interest, and/or its or their third party sublicensees or distributors, still hold non-exclusive or co-exclusive rights to distribute, market, promote and/or sell Product in the relevant country(ies)) to one or more Products in any one or more of the following countries: Japan, Taiwan or Indonesia. It is acknowledged and agreed that Schering-Plough’s rights under Section 2.3(a) no longer apply to the Peoples Republic of China.

     1.9 Rights to Cilag Autoinjector; Reimbursement of Development Costs . The Parties have agreed to develop and commercialize the Golimumab Product utilizing the autoinjector device developed by Cilag GmbH International (“ Cilag ”), an Affiliate of Centocor (the “ Cilag Autoinjector ”). Centocor shall be responsible for procuring the grant of any licenses, sublicenses or other rights from Cilag that are necessary to develop, manufacture and/or commercialize the Golimumab Product with the Cilag Autoinjector in the Territory; provided that any financial obligations to Cilag arising in connection with such license shall be subject to the provisions of Section 1.3 and Section 1.11 of this Amendment Agreement. In consideration for such rights and the Autoinjector Development Costs (as defined below) incurred by Cilag, Schering-Plough shall make a one time payment of twenty million five hundred thousand dollars ($20,500,000) within ten (10) business days after the Amendment Date. In addition, within thirty (30) days after the date of submission of the first application for Regulatory Approval of Golimumab Product in the EMEA, Schering-Plough shall pay to Centocor a milestone payment in the amount equal to the lesser of four million two hundred and fifty thousand dollars ($4,250,000) or the amount determined as follows:

(i)

[**] percent [**] of the total of all Autoinjector Development Costs incurred as of the date of such EMEA submission,

minus

(ii)

twenty million five hundred thousand dollars ($20,500,000).

Such milestone payment shall be made pursuant to an invoice (with supporting documentation in reasonable detail) to be provided to Schering-Plough by Centocor. Thereafter, to the extent that Schering-Plough’s total payments made pursuant to this Section 1.9 are less than twenty-four million, seven hundred and fifty thousand dollars ($24,750,000) and at all times subject to the Autoinjector Reimbursement Cap (as defined below), Centocor shall include [**]  percent [**] of the ongoing Autoinjector Development Costs incurred in a given calendar quarter in the quarterly Product

Development Cost billings for such calendar quarter under the Distribution Agreement. As used in this Section 1.9, the term “ Autoinjector Development Costs ” means the development costs incurred by Cilag in connection with the development of the Cilag Autoinjector (including Cilag’s or its Affiliates’ FTE costs, but excluding any Centocor FTE costs incurred on or after the Amendment Date); provided , however , that any costs and expenses incurred in connection with activities specifically directed to the use of the Cilag Autoinjector for any products other than Golimumab Product shall be excluded. The term “ Autoinjector Reimbursement Cap ” means an aggregate total of [**] dollars ($[**]) of Autoinjector Development Costs which is the maximum amount that will be subject to sharing and/or reimbursement by Schering-Plough under the terms of this Section 1.9. The Parties acknowledge and agree that the aggregate total of all of Schering-Plough’s payments pursuant to this Section 1.9 shall not exceed an amount equal to [**] percent ([**]%) of the Autoinjector Reimbursement Cap (i.e., twenty-four million, seven hundred and fifty thousand dollars ($24,750,000)), and that Schering-Plough shall have no obligation to reimburse or share in any portion of Autoinjector Development Costs that exceed the Autoinjector Reimbursement Cap. The Parties agree that any payments due under this Section 1.9 shall be paid by Schering-Plough directly to Cilag on Centocor’s behalf.

     1.10 Supplies of Cilag Autoinjector . (a) Schering-Plough hereby agrees to exclusively source all of its requirements for supplies of autoinjector devices for use in connection with the development and commercialization of Golimumab Product in the Territory from Centocor or its Affiliates and Centocor or its Affiliates shall be responsible for supplying to Schering-Plough such quantities of Cilag Autoinjector as it may order in accordance with the Autoinjector Supply Agreement (as defined below) for development and commercialization of the Golimumab Product in the Territory. As soon as practicable after the Amendment Date, the Parties will in good faith negotiate and enter into a supply agreement with respect to the Cilag Autoinjector (the “ Autoinjector Supply Agreement ”) which shall be consistent with the terms of the Distribution Agreement, as amended hereby, and the non-product and/or price specific terms of the Remicade Supply Agreement. The Autoinjector Supply Agreement shall, in any event, include provisions to provide that:

(i)

in the event of an actual or projected shortfall in supplies of Cilag Autoinjector, (x) Centocor shall ensure (A) that the available inventory and production capacity for that device is appropriately allocated based upon the collective firm orders and forecast requirements of the Parties for supplies of Cilag Autoinjector for use in connection with Golimumab Product (whether inside or outside the Territory) and any other firm orders and forecast requirements of Centocor or its Affiliates for supplies of the Cilag Autoinjector for the development and commercialization of Centocor’s or its Affiliates’ other products, and (B) that such supply quantity allocated to Golimumab Product requirements would be split between Schering-Plough (and its Affiliates), on the one hand, and Centocor (and its Affiliates) on the other hand, in

the same proportion as their respective firm orders and forecast requirements for supplies of Cilag Autoinjector for use in connection with Golimumab Products such that the shortfall in such supplies would be shared between them and (y) to the extent any such actual or projected shortfall results in forecasted market shortages for the Cilag Autoinjector, Schering-Plough and Centocor will jointly pursue alternative sourcing to ensure continued supply of autoinjector devices to both Parties; and

(ii)

in the event that Centocor develops a new autoinjector device for use with Golimumab Product and does not permit Schering-Plough to commercialize Golimumab Product utilizing such new device, Schering-Plough will be relieved of its obligations to source autoinjector devices for the Golimumab Product exclusively from Centocor.

The Parties will agree upon an initial price per unit to be paid by Schering-Plough for supplies of the Cilag Autoinjector under the Autoinjector Supply Agreement, which determination shall be made in connection with the determination of the initial supply price for Golimumab Product pursuant to Section 1.16. The supply price for the Cilag Autoinjector shall also be subject to periodic review and adjustment, as necessary, by the Product Committee in connection with any review and adjustment of the supply price for Golimumab Product pursuant to Section 6.1 of the Distribution Agreement. The foregoing notwithstanding, for purposes of Contribution Income calculations, the actual cost per unit of Cilag Autoinjector, without mark-up and subject to the application of the cap as set forth under Section 1.11, shall be used.

     (b)  Alternative Devices . In the event that the Parties agree to develop and/or commercialize Golimumab Product in the Territory using an alternative autoinjector device, the Parties shall also agree upon mutually acceptable arrangements for the manufacture and supply of supplies of the alternative device, it being understood that if a Party (or one of its Affiliates) has either internally developed such alternative device or licensed or acquired rights to such alternative device, that Party shall be primarily responsible for procuring the manufacture and supply of all requirements for supplies of the alternative device for use in connection with the Golimumab Product in the Territory. To the extent that Schering-Plough is the Party responsible for procuring supplies of such alternative autoinjector device, the Parties shall, upon request by Centocor, also negotiate in good faith and enter into a supply agreement for the manufacture and supply on commercially reasonable terms of Centocor’s requirements of such device for use in connection with Golimumab Product in countries outside the Territory. Any such supply agreement shall be consistent with the terms of the non-product and/or price specific terms of the Remicade Supply Agreement, including without limitation clauses to provide that in the event of an actual or projected shortfall in supplies of such device, (i) Schering-Plough shall ensure that the available inventory and production capacity for that device is appropriately allocated based upon the Parties’ firm orders and forecast requirements for the device for use in connection with Golimumab Products both within and outside the Territory and (ii) to the extent any such actual or projected shortfall results in forecasted market shortages for the device, Schering-Plough and Centocor will jointly pursue alternative sourcing to ensure continued supply of autoinjector devices to both Parties.

     1.11 Cost of Cilag Autoinjector for Contribution Income Purposes . The actual cost per unit for autoinjector de