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RESTRUCTURING AGREEMENT

Agreement and Plan of Merger

RESTRUCTURING AGREEMENT

 | Document Parties: CERUS CORP | Baxter Healthcare Corporation You are currently viewing:
This Agreement and Plan of Merger involves

CERUS CORP | Baxter Healthcare Corporation

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Title: RESTRUCTURING AGREEMENT
Governing Law: Illinois     Date: 5/10/2005
Industry: Biotechnology and Drugs     Sector: Healthcare

RESTRUCTURING AGREEMENT

, Parties: cerus corp , baxter healthcare corporation
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EXHIBIT 10.50

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

RESTRUCTURING AGREEMENT

 

 

This RESTRUCTURING AGREEMENT (“Agreement”) is entered into as of February 2, 2005 (the “Effective Date”) by and among Baxter Healthcare S.A., a corporation organized under the laws of Switzerland (“BHSA”), Baxter Healthcare Corporation, a company organized under the laws of Delaware (“BHC”), and Cerus Corporation, a company organized under the laws of Delaware (“Cerus”).  BHSA and BHC are sometimes collectively referred herein to as “Baxter.”  The foregoing entities are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

 

WHEREAS, BHC and Cerus are parties to a Development, Manufacturing and Marketing Agreement, dated as of December 10, 1993, as amended to the date hereof (the “Platelet Agreement”) relating to products referred to herein as the “Platelet System” and to a Development, Manufacturing and Marketing Agreement, dated April 1, 1996, as amended and restated June 30, 1998, as further amended to the date hereof (the “RBC/FFP Agreement”) relating to products referred to herein as the “Plasma System” and the “RBC System;” (The Platelet System, the Plasma System and the RBC System are sometimes referred to herein individually as a “System” and collectively as the “Systems”, and such terms are intended to have the same meanings herein as those set forth in the License Agreement and the Manufacturing and Supply Agreement being entered into concurrently herewith.)

 

WHEREAS, concurrently with this Agreement, Baxter Capital Corporation and Cerus are entering into an Amendment, Mutual Release and Settlement Agreement (the “BCC Settlement Agreement”) relating to a Loan and Security Agreement, dated as of November 15, 2002 (the “Loan Agreement”);

 

WHEREAS, BHA and BHSA are parties to a Research and Development Cost Sharing Agreement, dated January 1, 2001, for the designing, developing, manufacturing and marketing of various blood therapy products, including those related to the INTERCEPT Blood System;

 

WHEREAS, Baxter and Cerus desire to restructure the arrangements provided for in the Platelet Agreement and the RBC/FFP Agreement and resolve certain disputes that have arisen concerning those agreements, and in furtherance of such objectives Baxter and Cerus are entering into a License Agreement, Manufacturing and Supply Agreement, Transition Services Agreement, and a Trademark License Agreement (to which Baxter International Inc. is also a party) concurrently with this Agreement (such agreements referred to collectively as the “Concurrent Agreements”);

 

WHEREAS, as used in this Agreement, “Commercialization Rights” means, as to a particular country or region, (a) as to Baxter, the right and responsibility of Baxter to

 

EXECUTION

RESTRUCTURING AND SETTLEMENT AGREEMENT

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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market, distribute and sell the Platelet System pursuant to the Platelet Agreement, and the Plasma System pursuant to the RBC/FFP Agreement (and as further provided under this Agreement), in that country or region; or (b) as to Cerus, all rights of Cerus hereunder and under the Concurrent Agreements upon termination of Baxter’s Commercialization rights in that country or region.  For the purposes of this agreement, references to termination of Baxter Commercialization Rights, or to Cerus gaining Commercialization Rights, in a particular country or region means that licenses and related rights under the Platelet Agreement or the RBC/FFP Agreement, as the case may be, have been released and relinquished to Cerus, pursuant to Section 4 of this Restructuring Agreement;

 

NOW THEREFORE, in consideration of the premises and the covenants set forth herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows;

 

1.                                        CONDITIONS.  SUBSEQUENT PAYMENT.

 

1.1                                  Baxter’s Conditions Precedent.    The effectiveness of this Agreement and the obligations of Baxter hereunder are subject to the satisfaction, or waiver by Baxter, of the following conditions precedent:

 

(a)                                   Cerus shall have delivered, or caused to be delivered, original fully completed, dated and executed originals of this Agreement and the Concurrent Agreements; and

 

(b)                                  All conditions to be satisfied by Cerus pursuant to Section 7(a) of the BCC Settlement Agreement shall have been satisfied.

 

1.2                                  Cerus’ Conditions Precedent.   The effectiveness of this Agreement and the obligations of Cerus hereunder are subject to the satisfaction, or waiver by Cerus, of the following conditions precedent:

 

(a)                                   Baxter shall have delivered, or caused to be delivered, original fully completed, dated and executed originals of this Agreement and the Concurrent Agreements;

 

(b)                                  All conditions to be satisfied by BCC pursuant to Section 7(b) of the BCC Settlement Agreement shall have been satisfied.

 

                                                1.3                                  Subsequent Payment.  Baxter shall pay to Cerus the amount of [ * ]  Dollars ($ [ * ]  ) at the time of the next [ * ]  , which shall occur not later than [ * ]  .  In connection with such payment, BHC represents to Cerus that no payments have been made by BHC to BCC respecting Revenue Sharing Payments (as defined in the Platelet Agreement) due to Cerus with respect to Platelet System sales in the fourth quarter of 2004 (or the first quarter of 2005), any rights to Revenue Sharing payments now reverting to Cerus.

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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2.                                        COMMERCIALIZATION RIGHTS, MARKET ACTIVITIES AND FUNDING.

 

2.1                                  EU Commercialization Rights Through 2006. Subject to the terms of this Agreement, Baxter shall maintain Commercialization Rights for the Platelet System under the Platelet Agreement and the Plasma System under the RBC/FFP Agreement through December 31, 2006 in the countries listed on Exhibit A to this Agreement, (the “European Territory”).  Pursuant to such Commercialization Rights, Baxter shall (a) continue activities to achieve national and local approvals and gain market penetration of the Platelet System, and (b) activities to achieve national and local approvals (assuming CE mark approval) and market penetration of the Plasma System, in the countries of the European Territory.  These activities will include pre-launch activities for the Plasma System to be approved by the Governance Committee.   Through December 31, 2006 and any Extension Period, as defined below, Baxter will provide, at its expense all the necessary sales and marketing, distribution, regulatory, clinical/education and governmental affairs support to implement the plan to be approved by the Governance Committee.  To carry out these activities, Baxter agrees to commit, at its own expense, through December 31, 2006, Baxter personnel comprising not less than [ * ]  full-time-equivalent (FTE) employees in the European Territory in the areas itemized above, including not less than [ * ] employees, dedicated full-time, and [ * ] employees dedicated half-time, to marketing sales activities.

 

2.2                                  EU Commercialization Rights Extension 2007 — 2008.

 

(a)                                   Baxter will have the option to continue Commercialization Rights for the Platelet System and the Plasma System in the European Territory from January 1, 2007 through December 31, 2008 (together with any the “Extension Period”); provided that prior to [ * ]  , Baxter (i) provides Cerus with written notice of such election, (ii) the Platelet Agreement or the RBC/FFP Agreement has not been previously terminated pursuant to Section 12.1 hereof, and (iii) Baxter provides Cerus with assurance, satisfactory to Cerus in its reasonable judgment (and which could include further escrow of funds for marketing/promotional expenditures), that the funds and resources will be available as committed.  As used herein, the term “Extension Period” will mean such period of extension and any period of further extension pursuant to Section 2.3 below.  In the event that such conditions are not met by [ * ] , Baxter’s Commercialization Rights shall terminate effective January 1, 2007.

 

(b)                                  If Baxter exercises the election in Section 2.2(a), Baxter will be obligated, in each of calendar years 2007 and 2008, to (i) expend not less than [ * ] Dollars ($ [ * ] ) per year on marketing/promotional activities in the European Territory for the Platelet System and Plasma System, to be allocated between such programs as approved by the Governance Committee, and (ii) commit, at Baxter’s own expense, not less than [ * ] full-time-equivalent (FTE) employees in the European Territory in the areas itemized above, including not less than [ * ] employees, dedicated full-time and [ * ] employees dedicated half-time, to marketing and sales activities for the Platelet System, and not less than [ * ] additional employees dedicated full-time to marketing and

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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sales activities for the Plasma System, unless these commitments are revised through mutual agreement at the Governance Committee. However, if the Plasma System has not then received CE mark approval, and is not expected to receive such approval within such calendar year, the total expenditures for such year will be [ * ] Dollars ($ [ * ] ) and the [ * ] additional employees dedicated to marketing and sales activities for the Plasma System shall not be required for such calendar year.

 

2.3                                  EU Commercialization Rights Extension Post-2008.

 

(a)                                   Subject to Section 8.1 hereof, Baxter will have the option to continue Commercialization Rights for the Platelet System and the Plasma System in the European Territory from January 1, 2009 through December 31, 2010 and for subsequent successive two-year periods; provided that prior to [ * ] of the calendar year preceding the commencement of any such period, Baxter (i) provides Cerus with written notice of such election, (ii) the Platelet Agreement or the RBC/FFP Agreement has not been previously terminated pursuant to Section 12.1 hereof, and (iii) Baxter provides Cerus with assurance, satisfactory to Cerus in its reasonable judgment (and which could include further escrow of funds for marketing/promotional expenditures), that the funds and resources will be available as committed.  In the event that such conditions are not met by such February 28, Baxter’s Commercialization Rights shall terminate effective [ * ] of the succeeding calendar year.

 

(b)                                  If Baxter exercises the election in Section 2.3(a), Baxter will be obligated, in each of calendar years of the further Extension Period, to (i) expend not less than [ * ] Dollars ($ [ * ] ) per year on marketing/promotional activities in the European Territory for the Platelet System and Plasma System, to be allocated between such programs as approved by the Governance Committee, and (ii) commit, at Baxter’s own expense, not less than [ * ] full-time-equivalent (FTE) employees in the European Territory in the areas itemized above, including not less than [ * ] employees, dedicated full-time and [ * ] employees dedicated half-time, to marketing and sales activities for the Platelet System, and not less than [ * ] additional employees dedicated full-time to marketing and sales activities for the Plasma System, unless these commitments are revised through mutual agreement at the Governance Committee.  However, if the Plasma System has not then received CE mark approval, and is not expected to receive such approval within such calendar year, the total expenditures for such year will be [ * ] Dollars ($ [ * ] ) and the [ * ] additional employees dedicated to marketing and sales activities for the Plasma System shall not be required for such calendar year.

 

2.4                                  Reporting.                                       The Baxter INTERCEPT Marketing Manager for Europe will be the primary contact for the Governance Committee, and will be responsible for reporting on the status and progress of the agreed-upon activities.  Baxter will provide a monthly report to Cerus on market activities, including status and progress.

 

2.5                                  Intentionally Omitted.

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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2.6                                  Escrow Account.

 

(a)                                   Baxter will deposit in a joint BHC/Cerus escrow account (the “Escrow Account”) pursuant to an Escrow Agreement to be entered into substantially in the form of Exhibit B to this Agreement (the “Escrow Agreement”):

 

i.                                           [ * ] Dollars ($ [ * ] ) on or before the [ * ] day following [ * ] ;

 

ii.                                        [ * ] Dollars ($ [ * ] ) on or before [ * ] ; Baxter represents that this amount equals the difference between (x) [ * ] Dollars ($ [ * ] ) and (y) [ * ] by Baxter in the third and fourth calendar quarters of 2004 on marketing and promotional activities for the INTERCEPT Blood System, pursuant to the plan outlined and agreed upon by the Governance Committee, not including Baxter FTE and fringe benefit expenses; and

 

iii.                                     [ * ] Dollars ($ [ * ] ) on or before [ * ] .

 

(b)                                  The Governance Committee will meet periodically (not less frequently than quarterly) to review and approve expenditures that have been made for marketing/promotional activities to assure consistency with the previously-approved budget and plan.  Upon such approval, duly authorized signatures of Cerus and BHC will jointly sign instructions to the escrow agent to release funds to the Party (BHC, BHSA or Cerus) that incurred the expenditures.  With respect to expenditures pursuant to Section 2.8, a duly authorized signatory of Cerus may solely sign instructions to the escrow agent to release funds to BHC for qualifying expenditures under Section 2.8.

 

2.7                                  2005–2006 Commitment; Release From Escrow For Marketing/Promotional Activities.  Amounts deposited into the Escrow Account in 2005 and 2006 will be used to fund marketing/promotional expenses for the 2005 calendar year and 2006 calendar year, respectively, as further discussed in Section 8.1 below.  For the avoidance of doubt, these funds will be over and above, and will not be used to fund, Baxter FTE expenses committed in Section 2.1 hereof; provided, however, they may fund expenses of consultants and of additional employees (beyond the FTEs committed pursuant to Section 2.1 hereof) dedicated full-time to sales and marketing of INTERCEPT, if engagement of such resources is approved by the Governance Committee.  Approval of marketing and promotional expenditures will be governed by the terms of the Platelet Agreement and the Plasma Agreement, which provide for final plans and strategies to be established by the Management Board (now the Governance Committee) reasonably and in good faith.  Baxter and Cerus each agrees that the objective is to expend the full amount of these funds in each respective calendar year, and neither will unreasonably withhold its consent to such expenditures.

 

2.8                                  Release From Escrow For Plasma Development.  Notwithstanding the foregoing, Cerus may, in its sole discretion, direct that an amount not exceeding Two Million Two Hundred Thousand Dollars ($2,200,000) be released from the Escrow Account to reimburse Baxter for activities that Baxter may undertake at Cerus’ request to

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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continue development activities for the Plasma System directed toward CE Mark approval in the European Territory, and related manufacturing and validation, thereby releasing Cerus of the obligation for such payment from Cerus’ own funds.  Not more than (a) [ * ] Dollars ($ [ * ] ) of such funds will be released in 2005 (to reimburse Baxter for activities in [ * ] ), and not more than (b) [ * ] Dollars ($ [ * ] ) of such funds will be released in [ * ] (to reimburse Baxter for activities in [ * ] ).  Such release of funds will reduce the amount of the funds in the Escrow Account that would otherwise be dedicated to marketing/promotional expenses for the Plasma System, which the Parties agree is [ * ] Dollars ($ [ * ] ) for [ * ] , combined, before such reductions.

 

2.9                                  Distribution, Payment of Unused Funds.  Subject to Section 2.7, in the event the Governance Committee does not approve expenditure of the full amount of the escrowed funds allocated to [ * ] in that calendar year, or does not approve expenditure of the full amount of funds committed pursuant to Section 2.2(b) hereof in any year of the Extension Period, or if for any reason there are any such escrowed or committed amounts remaining unspent at the end of any such calendar year, the amount of unspent funds in the escrow account will be distributed equally to Baxter and Cerus within [ * ] days following the end of the calendar year.  With respect to any amounts committed pursuant to Section 2.2 or Section 2.3 for any Extension Period (if funds representing such amounts are not in the Escrow Account) one-half of the amounts so committed, but unspent, in any calendar year, will be paid by Baxter to Cerus within [ * ] days following the end of the calendar year.

 

2.10                            Marketing Plans and Activities.   For 2005, 2006 and of each year of the Extension Period, the joint Baxter/Cerus INTERCEPT marketing team will prepare and present to the Governance Committee a detailed marketing plan and budget for that calendar year for the Platelet System and Plasma System in the countries in the European Territory where Baxter retains Commercialization Rights.  The Governance Committee will approve such marketing plan and budget not later than [ * ] and [ * ] respectively of each respective year, and will also by [ * ] agree on a retention plan for dedicated INTERCEPT marketing personnel in the European Territory for 2005 and 2006 and each year of any Extension Period.  The Governance Committee must approve any subsequent changes to such plan or budget.  Neither Baxter nor Cerus will unreasonably withhold its approval of such plan or budget or subsequent revisions thereto.  Cerus will not unilaterally make any commitments to any customers that any studies will be funded by Baxter (including funding through the Escrow Account) relative to such customers.  In the event that Cerus does unilaterally make any such commitment, Cerus shall bear the expense of such study.

 

2.11                            North America Commercialization Rights.

 

(a)                                   Subject to the terms of this Agreement, Baxter shall maintain Commercialization Rights as to the Platelet System in North America.  It is understood that the Parties, intend to carry out discussions with the U.S. Food and Drug Administration (“FDA”) to gain clarification whether the Platelet System may be approved for marketing in the United States without additional clinical or other activities,

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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or whether additional such activities will be required.  When such question is answered with reasonable clarity (which the Parties anticipate will occur at a meeting with the FDA, and will not require formal written response from the FDA), Cerus will provide Baxter with a notice requesting Baxter to confirm whether Baxter desires to continue to maintain Commercialization Rights as to the Platelet System in North America. Baxter will have [ * ] days from the date of Cerus’ notice to respond by written notice to Cerus.  If Baxter responds that Baxter does not desire to maintain Commercialization Rights as to the Platelet System in North America, or if Baxter fails to respond strictly within such [ * ] day period, Baxter’s Commercialization Rights to the Platelet System in North America will immediately terminate upon such event.

 

(b)                                  If Baxter’s written notice of response states that Baxter desires to maintain Commercialization Rights as to the Platelet System in North America, then Baxter shall have the following obligations:

 

(i)                                      Baxter will fund one hundred percent (100%) of further clinical, development or other activities, including without limitation Phase 3b or Phase 4 studies, if required by the FDA for approval to market the Platelet System, and will use commercially reasonable efforts to carry out such activities and gain such approval;

 

(ii)                                   Baxter will use commercially reasonable efforts to launch the Platelet System in the United States as promptly as possible following FDA approval.  Baxter will expend not less than [ * ] Dollars ($ [ * ] ) per year on marketing/promotional activities in North America for the Platelet System during the calendar year preceding market launch and the next following calendar year, and will expend not less than [ * ] Dollars ($ [ * ] ) per year on marketing/promotional activities in North America for the Platelet System each calendar year thereafter.  In addition, Baxter will commit not less than [ * ] FTEs to sales and marketing of the Platelet System in North America.  The marketing/promotional expenses specified above will be over and above such FTE expenses, unless otherwise agreed by the Governance Committee.

 

2.12                            BioOne Territory Commercialization Rights.  With respect to the countries of Japan, China (including all Special Administrative Regions), Taiwan, South Korea, Thailand, Vietnam and Singapore (the “BioOne Territory”), Commercialization Rights continue to the extent provided in Section 4.4 of this Agreement; provided that if a transaction of the nature described in Section 3.2(c) hereof is not entered into with BioOne or another entity within [ * ] months of the date of this Agreement; Commercialization Rights as to the Plasma System will terminate in China (including Hong Kong and other specific administrative regions) and Japan.  In such event, the remainder of countries in the BioOne Territory will be considered ROW as to the Plasma System for the purposes of this Agreement.

 

2.13                            Rest of World Commercialization Rights.

 

(a)                                   As used herein, “Rest of World” or “ROW” means all countries other than the countries of the European Territory, North America and the BioOne

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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Territory, as such terms are defined herein; provided however that certain countries may be added to the ROW pursuant to the express provisions hereof.

 

(b)                                  Subject to the terms of this Agreement, Baxter shall maintain Commercialization Rights for the Platelet System under the Platelet Agreement and the Plasma System under the RBC/FFP Agreement in the countries of the ROW through the period provided for in this Section 2.13.

 

(c)                                   Baxter’s Commercialization Rights for the ROW will continue in effect for the same period as Baxter’s Commercialization Rights for the European Territory, subject to Section 8 hereof and to the following.  For 2005, 2006 and each year of the Extension Period, Baxter will prepare and present to the Governance Committee a detailed marketing plan and budget for that calendar year for the Platelet System and the Plasma System for specific countries in the ROW.  For 2005, such plan and budget for such specific countries will be presented not later than [ * ] days after the Effective Date, for approval by the Governance Committee its second calendar quarter meeting (if not approved sooner).  For subsequent calendar years, such budget and plan will be presented for approval by the Governance Committee not later than [ * ] of each respective year.  Not later than [ * ] of each succeeding year, the Governance Committee will review whether or not Baxter has performed the activities specified in the marketing plan and budget previously approved for each such country.  If Baxter has not performed the specified activities in any country, Cerus may elect, by written notice to Baxter, to terminate Baxter’s Commercialization Rights in such country.

 

(d)                                  If the marketing plan and budget for a particular ROW country presented by Baxter pursuant to Section 2.13(c) above is not approved by the Governance Board, Cerus may elect, by written notice to Baxter, to terminate Baxter’s Commercialization Rights in such country.  If Baxter and Cerus disagree at the Governance Committee level on whether the plan should be approved, the matter will be submitted for arbitration pursuant to Section 15.12 hereof.

 

(e)                                   If Baxter does not provide a marketing plan and budget for any year, as provided in Section 2.13(c) above for a country in the ROW, Cerus may request that Baxter provide such a plan and budget for such country.  If Baxter does not provide such a plan for such country within [ * ] days after such request, Cerus may elect, by written notice to Baxter, to terminate Baxter’s Commercialization Rights in such country.

 

(f)                                     If at any time for any reason, the rights granted to a partner revert to Baxter and Cerus with respect to any country of the ROW, then Baxter’s Commercialization Rights will automatically terminate as to such country, which shall be thereafter considered a Reverted Right Region.

 

(g)                                  Subject to Section 4.3, Baxter’s Commercialization Rights will automatically terminate as to all ROW countries upon termination of Baxter’s Commercialization Rights as to the European Territory, upon non-exercise by Baxter of its election pursuant to Section 2.3 (a); provided, however, that if the termination of

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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European Territory Commercialization Rights occurs through exercise by Cerus of the European Territory Buy-Out rights pursuant to Section 8.1 hereof, Cerus may obtain such rights as to the ROW country only through exercise of its ROW country Buy-Out Rights pursuant to Section 8.2 hereof.

 

2.14                            Condition to Extensions.   It shall be a condition to exercise of Baxter’s options to extend any Commercialization Rights into any Extension Period that Baxter shall be in compliance, in all material respects, with the requirements of this Agreement, the Platelet Agreement, the RBC/FFP Agreement (as to Plasma System matters) and the Concurrent Agreements at the time of such exercise.

 

3.                                        DEVELOPMENT.

 

3.1                                  Platelets.

 

(a)                                   Cerus and Baxter acknowledge and agree that the Cooperative Development Work, as defined in the Platelet Agreement:

 

(i)                                      is completed, effective January 1, 2005, with respect to activities directed toward the European Territory;

 

(ii)                                   continues with respect to activities directed toward North America, subject to the following:  After the Effective Date, the Cooperative Development Work will be initially limited to preparing (to the extent not already prepared), and submitting to the FDA,  such documents as Cerus deems appropriate, and participating in one or more meetings with the FDA.  The purpose of such activities is to gain clarification whether the Platelet System may be approved for marketing in the United States without additional clinical or other activities, or whether additional such activities will be required.  Cerus will have the primary discretion to determine the strategy for communications with the FDA, subject to Baxter’s approval, and Baxter will conduct such communications, including meetings, with the participation of Cerus.  Each Party will bear its own expenses of such activities.  Following such activities, if Baxter, pursuant to the Section 2.11(b), provides notice that Baxter desires to maintain Commercialization Rights as to the Platelet System in North America, then the Cooperative Development work will continue (if additional development activities are required) with Baxter thereafter bearing all costs of such activities as provided in Section 2.11(b)(i).  If, pursuant to Section 2.11(a), Baxter does not maintain Commercialization Rights as to the Platelet System in North America, the Cooperative Development Work will then be considered terminated as to the Platelet System in North America.

 

(b)                                  With respect to the BioOne Territory, Baxter and Cerus acknowledge that development and commercialization will be carried on by BioOne Corporation (“BioOne”) pursuant to agreements previously entered into with BioOne BHC, BHSA and Cerus each agrees to perform its obligations under such agreements in support of BioOne’s activities. Such activities will not be considered Cooperative Development work that is subject to joint funding under the Platelet Agreement.

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(c)                                   With respect to activities concerning the Platelet System directed to the ROW, the parties will pursue commercialization as provided in Section 2.13 hereof.  Such activities will be at Baxter’s expense and will not be considered Cooperative Development work that is subject to joint funding under the Platelet Agreement, unless the parties otherwise agree at the Governance Committee level.  It is understood that Baxter has no obligation to make any System modifications, or fund any clinical studies, that may be necessary to gain approval in any ROW country, but Baxter agrees that the expenses of any regulatory personnel and activities in such country will be solely Baxter’s responsibility.

 

3.2                                  Plasma.

 

(a)                                   Cerus and BHC acknowledge and agree that the Cooperative Development Work, as defined in the RBC/FFP Agreement, for the Plasma System;

 

(i)                                      continues with respect to activities directed toward obtaining CE Mark in the European Territory;

 

(ii)                                   is terminated, effective January 1, 2005, with respect to activities directed to North America;

 

(b)                                  With respect to activities directed toward obtaining CE Mark for the Plasma System and related manufacturing and validation, Baxter agrees, at Cerus’ request and expense, to carry out the further development activities set forth on Exhibit C to this Agreement within the time schedules set forth on such Exhibit for such activities.  The charge for such activities will not exceed the amount set forth on such Exhibit, provided that the scope of such activities is not expanded.  Cerus agrees to fund those Baxter activities, as well as Cerus activities, directed toward completing the application for CE Mark, including through funding from the Escrow Account pursuant to Section 2.8, above.

 

(c)                                   With respect to the countries of the BioOne Territory, it is acknowledged that Cerus has been discussing with BioOne and Baxter a potential transaction related to the Plasma System that is similar to the transaction previously entered into for the Platelet System.  In the event such a transaction is entered into, it is anticipated that development and commercialization will be carried on by BioOne.  Pending the completion of the transactions, the Parties do not expect that any Cooperative Development work will be funded specifically directed to the countries of the BioOne Territory.  The parties agree to cooperate to supply information to BioOne and engage in discussions with BioOne to facilitate the completion of such transaction. Such activities will not be considered Cooperative Development work that is subject to funding under the RBC/FFP Agreement.  In the event that such transaction is not entered into with BioOne or another entity within [*] months of the date of this Agreement, the Cooperative Development Work for the Plasma System will be considered terminated with respect to the countries of the BioOne Territory.

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(d)                                  With respect to activities concerning the Plasma System directed to the ROW, the parties will pursue commercialization as provided in Section 2.13 hereof.  Such activities will be at Baxter’s expense and will not be considered Cooperative Development work that is subject to joint funding under the RBC/FFP Agreement, unless the parties otherwise agree at the Governance Committee level.  It is understood that Baxter has no obligation to make any System modifications, or fund any clinical studies, that may be necessary to gain approval in any ROW country, but Baxter agrees that the expenses of any regulatory personnel and activities in such country will be solely Baxter’s responsibility.

 

3.3.                               Red Blood Cells.   Cerus and BHC acknowledge and agree that the Cooperative Development Work, as defined in the RBC/FFP Agreement, for the RBC System is terminated, effective January 1, 2005, with respect to activities directed to all countries of the world; provided that Baxter shall promptly complete in 2005 the chronic and acute close-out clinical trial reports on the RBC program that had been scheduled for completion in 2004, and furnish such reports to Cerus, which shall be at Baxter’s own expense with respect to any activities in 2005.

 

4.                                        RELINQUISHMENT OF RIGHTS.

 

4.1                                  Rights Relinquished.  BHC and BHSA each hereby releases and relinquishes to Cerus all of its licenses and related rights under the Platelet Agreement and the RBC/FFP Agreement to Cerus Patents, Cerus Know-How, Cerus Licensed Patents, Cerus Licensed Know-How and Cerus Compounds, Cerus Inventions, Cerus Project Inventions and Contractor Inventions, as such terms are defined in such agreements respectively, as follows in the following regions (the “Reverted Right Regions,” each a “Reverted Right Region” as to the particular System or Systems):

 

(a)                                   Plasma.  Under the RBC/FFP Agreement, as to the field of inactivation of pathogens in plasma components of blood: all licenses and related rights in North America;

 

(b)                                  Red Blood Cells.  Under the RBC/FFP Agreement, to the field of inactivation of pathogens in red blood cells: all licenses and related rights worldwide;

 

(c)                                   Other.  Under the RBC/FFP Agreement, as to any other part of the Field (as such term is defined in such agreement) that is not mentioned in Sections 4.1(a) and 4.1(b) above: all licenses and related rights worldwide.

 

4.2                                  Rights Relinquished on Subsequent Termination of Commercialization Rights.  Effective upon the termination of Commercialization Rights as to the Platelet System or the Plasma System in any country as to which licenses and rights were not previously released and relinquished pursuant to Section 4.1, BHC and BHSA each will automatically release and relinquish to Cerus all of its licenses and related rights under the Platelet Agreement and the RBC/FFP Agreement, as the case may

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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be, to Cerus Patents, Cerus Know-How, Cerus Licensed Patents, Cerus Licensed Know-How and Cerus Compounds, Cerus Inventions, Cerus Project Inventions and Contractor Inventions, except to the extent that Commercialization Rights are expressly retained by Baxter hereunder after such date.  At such time, such country will become part of the Reverted Right Regions.

 

4.3                                  Rights Retained for Third Party Agreements.   If an agreement is reached, on or before [ * ] , or during [ * ] , if applicable, with a partner or partner(s) for commercialization of the Platelet System or the Plasma System in any country (outside the BioOne Territory) in which Baxter then retains Commercialization Rights for such System, licenses and related rights in such country will remain subject to the Platelet Agreement or the RBC/FFP Agreement, case may be, as necessary to support such third party agreement. (Any such third party agreement will require the approval of Baxter and Cerus.) Revenues from such agreement [ * ] .  However, if at any time for any reason, the rights granted to such third party revert to Baxter/Cerus with respect to such country, then Baxter’s license and related rights shall automatically be released and relinquished to Cerus as to such System in such country, which shall be thereafter considered a Reverted Right Region.  If the Parties are unable to complete such mutually acceptable agreements in a country on or before the date on which Baxter’s Commercialization Rights terminate in such country, such country will become part of the Reverted Rights Region as of the date of termination of the Commercialization Rights.

 

4.4                                  Rights Retained For Performance of BioOne Agreements. Notwithstanding Section 4.2, Baxter will retain any licenses and related rights necessary to support the licenses granted by Baxter to BioOne and to enable Baxter to carry out its commitments (a) to BioOne under the BioOne Agreements concerning the Platelet System, and (b) under future agreements (with respect to the BioOne Territory) that may be entered into between Cerus, Baxter and BioOne or another entity pursuant to the terms of the Agreement.  However, if at any time for any reason, the rights granted to BioOne or other entity as to the Platelet System or the Plasma System revert to Baxter/Cerus with respect to China or Japan, then Baxter’s license and related rights shall automatically be released and relinquished to Cerus as to such country, which shall be thereafter considered a Reverted Right Region as to such System (subject to Baxter’s rights under section 5.6 of the License Agreement).  If such rights revert to Baxter/Cerus as to a System in any other country of the BioOne Territory, such country will thereafter be considered part of ROW for the purposes of this Agreement.

 

4.5                                  Regulatory Transfer.  Baxter hereby transfers to Cerus the regulatory rights and future responsibility for the Platelet System, the Plasma System and the RBC System in the respective Reverted Rights Regions applicable to each such System as of such date. Baxter will make a prompt subsequent orderly transfer of the related regulatory documents to Cerus.

 

4.6                                  Regulatory Transfer on Other Events.  Upon any event resulting in addition of a country or region to the Reverted Rights Regions as to any System, there shall be automatically transferred to Cerus the regulatory rights and future responsibility

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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for such Systems in such country or region.  Baxter will, as early as reasonably possible, make an orderly transfer of the related regulatory documents to Cerus.

 

4.7                                  Cross-Reference to Baxter Regulatory Files.  Following the transfers of regulatory rights and responsibilities described above, Cerus shall continue to be able to cross-reference any regulatory files of Baxter as necessary or useful to support regulatory submissions for the Platelet System the Plasma System and the RBC System.  Baxter shall, at Cerus’ request, execute and provide to Cerus such other documents as are necessary or appropriate to notify any regulatory agency of such authorization.

 

5.                                        LICENSE AGREEMENT; TRADEMARK LICENSE.

 

5.1                                  License Agreement.  Concurrently with this Agreement, Baxter and Cerus are entering into a License Agreement (the “License Agreement”) whereby Baxter licenses to Cerus certain rights to certain patents, know-how and materials, all as described in the License Agreement, related to the INTERCEPT Blood System in the Reverted Rights Regions.

 

5.2                                  No Diligence Obligations.   For the purpose of dispute avoidance, it is agreed that Cerus has no diligence obligations to develop or commercialize products under this Agreement or the License Agreement, except as set forth in Section 3.2(b) concerning activities related to the application for CE Mark for the Plasma System.

 

5.3                                  Trademark License Agreement .  Concurrently with this Agreement, Baxter and Cerus are entering into a Trademark License Agreement (the “Trademark License”) whereby certain rights in the INTERCEPT Blood mark, other marks that include the INTERCEPT name, and any designs associated therewith, are licensed to Cerus in the countries in which Cerus gains Commercialization Rights.

 

6.                                        MANUFACTURING AND SUPPLY.

 

6.1                                  Platelets and Plasma in the Countries Where Baxter Retains Commercialization Rights.

 

(a)                                   For the purpose of clarity, so long as Baxter retains Commercialization Rights hereunder for the Platelet System or the Plasma System, as the case may be, for a particular country or region, Baxter will continue to manufacture Platelet Systems and related products as provided in the Platelet Agreement, and Plasma Systems and related products as provided in the RBC/FFP Agreement, for such country or region, as well as sets for use in development and clinical testing of such Products in such country or region.  Except for costs Cerus has previously expressly agreed to incur in connection with design transfer for relocation of Plasma System manufacturing from [ * ] to [ * ] , Baxter will bear all costs of relocation and revalidating manufacturing facilities.  Any costs involved with such relocation will not increase the Cost of Goods to Cerus over the Cost of Goods that was in effect as to manufacture of any System at the previous location.

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(b)                                  Notwithstanding Section 6.1(a), the Parties will cooperate to attempt to identify suppliers that could manufacture or assemble complete Platelet Sets and Plasma Sets at lower cost than Baxter’s Cost of Goods and at equal or superior quality to Baxter’s manufacture or assembly.  (Such supplier would be permitted to obtain at cost Baxter raw materials for such use in manufacture or components for use in assembly).  In the event that the Parties’ identify such a supplier, or Cerus individually identifies such a supplier, Cerus may provide written notice to Baxter of its request that Baxter utilize such supplier in order to reduce the Cost of Goods for a particular System.  (Cerus may provide such notice, however, only if Baxter has elected to extend its Commercialization Rights into an Extension Period.) Within [ * ] months of its receipt of such notice Baxter shall either (a) reduce its Cost of Goods for the particular System to be no greater than that which would pertain by use of such supplier, or (b) commence payment to Cerus of additional Revenue Sharing Payments (as defined under the Platelet Agreement and the RBC/FFP Agreement) equal to the additional amounts that Cerus would receive if the supplier were utilized, or (c) commence transition to such supplier and thereafter use commercially reasonable efforts to expeditiously complete such transition.  As used herein, the terms “Platelet Sets” and “Plasma Sets” shall mean “Inactivation Packages” (as defined in the Platelet Agreement and the RBC/FFP Agreement) for the Platelet System and the Plasma System, respectively.

 

6.2                                  Manufacturing and Supply Agreement.  To assure Cerus a supply of products for a certain period in those countries and regions in which Cerus gains Commercialization Rights, Baxter and Cerus are entering into a Manufacturing and Supply Agreement of even date herewith.

 

6.3                                  Obligations to BioOne.   Baxter agrees, for the benefit of Cerus, to manufacture products and materials, components and subassemblies for BioOne pursuant to the Manufacturing and Supply Agreement previously entered into with BioOne for the Platelet System, and agreements, if any, that may be entered into with BioOne or other party for the Plasma System, and to otherwise comply with its obligations under the BioOne Agreements and such other agreements, if any.

 

7.                                        TRANSITION SERVICES.  To assure a smooth transition of rights and responsibilities concerning marketing, sales and distribution responsibilities in any country upon termination of Baxter’s Commercialization Rights in such country, concurrently with this Agreement, Baxter and Cerus are entering into a Transition Services Agreement (the “Transition Services Agreement”).

 

8.                                        CERUS BUY-OUT OF COMMERCIALIZATION RIGHTS.

 

8.1                                  European Territory Buy-Out.   If Baxter exercises the election under Section 2.3(a) to continue Commercialization Rights into any Extension Period, commencing with the [ * ] Extension Period, Cerus will have the election (the “European Territory Buy-Out Rights”) to terminate Baxter’s Commercialization Rights in the European Territory as to the Platelet System and the Plasma System, effective as of [ * ] ,

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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or as of the first day of any subsequent Extension Period, as the case may be.  For the purpose of clarity, in such event, Baxter’s Commercialization Rights will not continue into such Extension Period, even though Baxter elected to so continue.   Such election will apply to the entire European Territory, and may not be exercised on a country-by-country basis.

 

(a)                                   To make such election, Cerus will so notify Baxter in writing not later than the [ * ] next following the [ * ] deadline for Baxter’s exercise of its election pursuant to Section 2.3(a).

 

(b)                                  In consideration of such election, Cerus shall pay to Baxter an amount (the “European Territory Buy-Out Price”) computed as follows:  The European Territory Buy-Out Price shall be equal to (i) [ * ] times Baxter’s Adjusted Gross Margin (as defined in Section 8.3) on sales of the Platelet System, and (ii) [ * ] times Baxter’s Adjusted Gross Margin on sales of the Plasma System; in the European Territory for the [ * ] months preceding [ * ] of the calendar year of Cerus’ election notice pursuant to clause (a) immediately above.

 

8.2                                  ROW Country Buy-Out.   Cerus will have the election (the “ROW Country Buy-Out Rights”) to terminate Baxter Commercialization Rights as to any ROW country as of the first day of any calendar year commencing with [ * ] .

 

(a)                                   To make such election, Cerus will so notify Baxter in writing not later than July 1of the calendar year prior to the calendar year in which such termination is to become effective.

 

(b)                                  In consideration of such election, Cerus shall pay to Baxter an amount (the “ROW Country Buy-Out Price”) computed as follows:  The ROW Country Buy-Out Price for a particular country shall be equal to (i) [ * ] times Baxter’s Adjusted Gross Margin on sales of the Platelet System, and (ii) [ * ] times Baxter’s Adjusted Gross Margin on sales of the Plasma System; in such country for the [ * ] months preceding [ * ] of the calendar year of Cerus’ election notice; provided, however, that the ROW Country Buy-Out price for any country will be not less than the amount of Baxter’s expenditures (not including FTE costs except for employees dedicated full-time to commercial activities concerning the Platelet System and the Plasma System in such country) on commercial activities dedicated to the Platelet System and the Plasma System in that country during the [ * ] months preceding such [ * ] date.

 

8.3                                  Adjusted Gross Margin.              As used in this Section 8, Baxter’s Adjusted Gross Margin means Baxter’s gross sales revenues, less product return credits and pricing adjustments, as determined in accordance with generally accepted accounting principles, consistently applied (GAAP) and in accordance with Baxter’s normal accounting policies consistently applied, minus Revenue Sharing Payments (as defined in the Platelet Agreement and the RBC/FFP Agreement) paid or payable to Cerus in respect of such sales revenues and minus Baxter’s Cost of Goods (as defined in such agreements and amended by this Agreement).

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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8.4                                  Buy-Out Process.  Baxter shall notify Cerus in writing of the amount of Adjusted Gross Margin pertinent to computing the European Territory Buy-Out Price or the ROW Country Buy-Out Price, as the case may be, and furnish Cerus with the information supporting such calculation, as promptly as such information becomes available to Baxter, following the relevant [*] date.  Cerus shall notify Baxter within [ * ] days following receipt of such notice whether Cerus accepts such amount or disputes such amount.  If Cerus disputes such amount, Baxter and Cerus will follow the dispute resolution procedure provided in Section 15.12(c) hereof to determine the amount.  Any dispute concerning the Adjusted Gross Margin amount will not affect or delay the termination of the respective Commercialization Rights, nor the obligation of Cerus to pay the respective Buy-Out Price, once such amount is finally determined.

 

8.5                                  Payment Date.  The European Territory Buy-Out Price or ROW Country Buy-Out Price will be paid not later than the third business day of the calendar year in which the termination of Baxter’s Commercialization Rights becomes effective pursuant to the European Territory Buy-Out or the ROW Country Buy-Out, as the case may be.

 

9.                                        REVENUE SHARING.

 

9.1                                  Under Platelet and RBC/FFP Agreement.  Revenues from the sale of Platelet Systems and related products, and Plasma Systems and related products, in any country where Baxter retains Commercialization Rights, will continue to be shared as provided in the Platelet Agreement and the RBC/FFP Agreement, respectively, subject, however to Section 9.3 below.  In addition, during any Extension Period, in computing Premium with respect to Plasma Systems, Baxter’s Marketing and Administrative Expenses for any calendar year shall be limited to twelve percent (12%) of Baxter’s Net Sales for such calendar year (as the terms “Premium,” “Marketing and Administrative Expens


 
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