Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 177

DECLARATION re 173 MOTION to Compel Production of Documents of Krista M. Carter (REDACTED VERSION) by Amgen Inc.. (Attachments: # 1 Confidential Exhibit Coversheet# 2 Exhibit 4, part one# 3 Exhibit 4, part two# 4 Exhibit 4, part three# 5 Exhibit 5# 6 Exhibit 17# 7 Exhibit 22# 8 Exhibit 29# 9 Exhibit 30)(Gottfried, Michael)

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Amgen Inc. v. F. Hoffmann-LaRoche LTD et al Doc. 177 Att. 3 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 1 of 41 Exhibit 4 Part 2 of 3 Dockets.Justia.com Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 2 of 41 including all documents forecasting hemoglobin by any dose level, use, customer, customer segment or patient category. RESPONSE TO REQUEST NO. 68: Roche incorporates herein by reference its Response to Request No . 67 above. REQUEST NO. 69: All documents and things relating to any current or projected effect of MIRCERA pricing on any large dialysis organization, small dialysis organization, hospital, nephrology clinic, physician, the Veterans Administration, pharmacies, wholesalers or retailers, including any effect on such entities' purchasing, consumption, use, reimbursement or profitability. RESPONSE TO REQUEST NO. 69: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence. In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to pricing, that bear no relevance to any claim or defense in this action . Roche will therefore produce such documents only to the extent they relate to the factors considered in a preliminary or permanent injunction determination should those issues arise . To the extent Amgen seeks remedies beyond injunctive relief, Roche reserves the right to supplement its response to this Request. Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. 3 ] 362550_V23 .DOC 41 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 3 of 41 REOUEST NO . 70: All documents and things relating to any current or projected effect of ROCHE's pricing of MIRCERA on the average wholesale price, the wholesale acquisition cost or the average ® selling price of any other ESP (including EPOGEN , ARANESP O and PROCRIT®). RESPONSE TO REQUEST NO . 70: Roche objects to this Request's use of the terms "wholesale price," "wholesale acquisition cost' 'and "average selling price" to the extent they are vague, ambiguous and undefined. Roche incorporates herein by reference its Response to Request No . 69 above. REOUEST NO . 71: All documents and things relating to any current or projected effect of ROCHE's pricing of MIRCERA on the pricing, sales or use of any ESP for treatment of oncology patients. RESPONSE TO REQUEST NO. 71: Roche incorporates herein by reference its Response to Request No . 69 above. REQUEST NO . 72: All documents and things that comprise or relate to any budget or plan of ROCHE medical affairs relating to MIRCERA in the United States, including all goals, budgets, forecasts, milestones, minutes, agendas, presentations, task lists, schedules and plans of action of each team or group involved therein. RESPONSE TO REQUEST NO . 72: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence. In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, such as sales and costs, that bear no relevance to any claim or defense in this action . Roche will therefore produce such documents only to the extent they relate to the factors considered in a preliminary or permanent injunction determination should those issues arise . To the extent Amgen seeks remedies beyond injunctive relief, Roche reserves the right to supplement its response to this Request. 31362550 V23 .DOC 42 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 4 of 41 Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REQUEST NO. 73: All documents and things generated by or for ROCHE medical affairs since January 1, 2005 that reference or relate to preparations for or the commercial launch, supply, commercialization, clinical development, promotion, pricing, sale or reimbursement of MIRCERA in the United States, including all goals, budgets, forecasts, milestones, minutes, agendas, presentations, task lists, schedules and plans of action of each team or group involved therein. RESPONSE TO REOUEST NO .73: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request to the extent it seeks documents and things relating to ongoing clinical trials post-dating Roche's filing of its BLA No . STN 125164/0 . In order to avoid unnecessarily delaying or disrupting these trials, Roche will provide relevant documents relating to these trials only upon their completion, if any. In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, such as sales, costs, pricing, marketing and reimbursement, that bear no relevance to any claim or defense in this action . Roche will therefore produce such documents only to the extent they relate to the factors considered in a preliminary or permanent injunction determination should those issues arise . To the extent Amgen seeks remedies beyond injunctive relief, Roche reserves the right to supplement its response to this Request. 31362550 V23 .DOC 43 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 5 of 41 Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REQUEST NO. 74: All documents and things generated by or for ROCHE medical affairs since January 1, 2005 that reference or relate to current or future use of MIRCERA in the United States, including all goals, budgets, studies, clinical trials, protocols, forecasts, minutes, agendas, presentations, task lists, schedules and plans of action of each team or group involved therein. RESPONSE TO REQUEST NO . 74: Roche incorporates herein by reference its Response to Request No . 73 above. REQUEST NO . 75: All documents and things generated by or for ROCHE medical affairs since January 1, 2005 that reference or relate to the current or future cost or reimbursement of MIRCERA use in the United States, including all goals, budgets, studies, clinical trials, protocols, forecasts, milestones, minutes, agendas, presentations, task lists, schedules and plans of action of each team or group involved therein. RESPONSE TO REQUEST NO. 75: Roche incorporates herein by reference its Response to Request No . 73 above. REQUEST NO . 76: All documents and things that comprise or relate to any budget or plan of ROCHE governmental affairs relating to MIRCERA in the United States, including all goals, budgets, forecasts, milestones, minutes, agendas, presentations, task lists, schedules and plans of action of each team or group involved therein. RESPONSE TO REQUEST NO . 76: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence. 31362550 v23 .DOC 44 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 6 of 41 In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, such as sales and costs, that bear no relevance to any claim or defense in this action . Roche will therefore produce such documents only to the extent they relate to the factors considered in a preliminary or permanent injunction determination should those issues arise . To the extent Amgen seeks remedies beyond injunctive relief, Roche reserves the right to supplement its response to this Request. Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REQUEST NO. 77: All documents and things generated by or for ROCHE governmental affairs since January 1, 2005 that reference or relate to preparations for or the commercial launch, supply, commercialization, clinical development, promotion, pricing, sale or reimbursement of MIRCERA in the United States, including all goals, budgets, forecasts, milestones, minutes, agendas, presentations, task lists, schedules and plans of action of each team or group involved therein. RESPONSE TO REQUEST NO. 77: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request to the extent it seeks documents and things relating to ongoing clinical trials post-dating Roche's filing of its BLA No . STN 125164/0 . In order to avoid unnecessarily delaying or disrupting these trials, Roche will provide relevant documents relating to these trials only upon their completion, if any. 31362550_V23 .DOC 45 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 7 of 41 In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, such as sales, costs, pricing, marketing and reimbursement, that bear no relevance to any claim or defense in this action. Roche will therefore produce such documents only to the extent they relate to the factors considered in a preliminary or permanent injunction determination should those issues arise . To the extent Amgen seeks remedies beyond injunctive relief, Roche reserves the right to supplement its response to this Request. Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REQUEST NO. 78: All documents and things generated by or for ROCHE governmental affairs since January 1, 2005 that reference or relate to current or future use of MIRCERA in the United States, including all goals, budgets, studies, clinical trials, protocols, forecasts, minutes, agendas, presentations, task lists, schedules and plans of action of each team or group involved therein. RESPONSE TO REQUEST NO . 78: Roche incorporates herein by reference its Response to Request No . 77 above. REOUEST NO. 79: All documents and things generated by or for ROCHE governmental affairs since January 1, 2005 that reference or relate to the current or future cost or reimbursement of MIRCERA use in the United States, including all goals, budgets, studies, clinical trials, protocols, forecasts, milestones, minutes, agendas, presentations, task lists, schedules and plans of action of each team or group involved therein. RESPONSE TO REQUEST NO . 79: Roche incorporates herein by reference its Response to Request No . 77 above. 31362550_v23 .DOC 46 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 8 of 41 REQUEST NO. 80: All documents and things relating to any analysis or evaluation of any reimbursement rate, plan or policy for future MIRCERA use in the United States, including average selling price, discounts, rebates or other incentives for purchase or use of MIRCERA with patients. RESPONSE TO REQUEST NO . 80: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request's use of the term "average selling price" to the extent it is vague, ambiguous and undefined. In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, particularly relating to pricing and reimbursement, that bear no relevance to any claim or defense in this action . Roche will therefore produce such documents only to the extent they relate to the factors considered in a preliminary or permanent injunction determination should those issues arise . To the extent Amgen seeks remedies beyond injunctive relief, Roche reserves the right to supplement its response to this Request. Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REQUEST NO. 81: All documents that comprise or relate to any plan, forecast or projection of Medicare, Medicaid and/or private reimbursement rates or policies for MIRCERA use in the United States at any time during 2006, 2007, 2008 and/or 2009. 31362550_V23 .DOC 47 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 9 of 41 RESPONSE TO REQUEST NO . 81: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence. In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, particularly relating to pricing and reimbursement, that bear no relevance to any claim or defense in this action . Roche will therefore produce such documents only to the extent they relate to the factors considered in a preliminary or permanent injunction determination should those issues arise. To the extent Amgen seeks remedies beyond injunctive relief, Roche reserves the right to supplement its response to this Request. Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REQUEST NO . 82: All documents and things relating to any analysis, evaluation or presentation regarding the pharmaco-economics of MIRCERA use in anemic renal dialysis patients and/or anemic renal patients not on dialysis. RESPONSE TO REQUEST NO . 82: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request because the term "pharmaco-economics" is vague, ambiguous and undefined. 31362550 V23 .DOC 48 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 10 of 41 REQUEST NO . 83: All documents and things relating to any comparison of the pharmaco-economics of MIRCERA use in anemic patients with the pharmaco-economics of the use of any other ESP in anemic patients, including EPOGEN®, ARANESP® and PROCRIT®. RESPONSE TO REQUEST NO. 83: Roche incorporates herein by reference its Response to Request No . 82 above. REQUEST NO . 84: All documents and things relating to any analysis, evaluation or presentation regarding the hemoglobin and/or dose response of anemic patients receiving MIRCERA therapy. RESPONSE TO REQUEST NO . 84: Roche objects to this Request as cumulative of Request No . 67 . Roche incorporates herein by reference its Response to Request No . 67 above. REQUEST NO. 85: All documents and things relating to any communication, meeting, presentation or proposal between ROCHE and any representative of any public or private reimbursement authority or agency in the United States (including the CMS, GAO, any state Medicaid authority or any private reimbursement or health maintenance organization) relating to the current or future sale, use, efficacy, safety, cost-effectiveness, reimbursement or pricing of any ESP, including MIRCERA. RESPONSE TO REOUEST NO. 85: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request as overly broad and seeking information not relevant to any claim or defense in this action to the extent it refers to "any ESP" other than MIRCERA. In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, particularly relating to future sale, cost-effectiveness, reimbursement and pricing, that bear no relevance to any claim or defense in this action . Roche will therefore produce such documents only to the extent they 31362550_V23 .DOC 49 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 11 of 41 relate to the factors considered in a preliminary or permanent injunction determination should those issues arise . To the extent Amgen seeks remedies beyond injunctive relief, Roche reserves the right to supplement its response to this Request. Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REQUEST NO. 86: All documents and things relating to any communication, meeting, presentation or proposal between ROCHE and any representative of any public or private reimbursement authority or agency in the United States (including the CMS, GAO, any state Medicaid authority or any private reimbursement or health maintenance organization) relating to any analysis, evaluation or presentation regarding the hemoglobin and/or dose response of anemic patients receiving ESP therapy. RESPONSE TO REOUEST NO. 86: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request as overly broad and seeking information not relevant to any claim or defense in this action to the extent it is not limited to anemic patients receiving MIRCERA TM Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copymg. 31362550_V23 .DOC 50 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 12 of 41 REQUEST NO. 87: All documents and things relating to the "White Paper" attached hereto as Exhibit A, including communications within ROCHE or between ROCHE and any third party regarding the White Paper, any draft of the White Paper or communications referenced in the White Paper. RESPONSE TO REQUEST NO . 87: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence. Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REOUEST NO . 88: All documents and things relating to any current or projected effect of the sale of MIRCERA in the United States on government reimbursement of ESP use in the United States, including the effect on reimbursement of EPOGEN ® , ARANESP O and PROCRIT® . RESPONSE TO REQUEST NO. 88: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence. In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to sales and reimbursement, that bear no relevance to any claim or defense in this action . Roche will therefore produce such documents only to the extent they relate to the factors considered in a preliminary or permanent injunction determination should those issues arise. To the extent Amgen seeks remedies beyond injunctive relief, Roche reserves the right to supplement its response to this Request. 31362550_V23 .DOC 51 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 13 of 41 Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REQUEST NO . 89: All documents and things that comprise or relate to ROCHE's 2006, 2007 and 2008 sales budget and plan for MIRCERA in the United States, including all goals, budgets, forecasts, milestones, minutes, agendas, presentations, task lists, schedules and plans of action of each team or group involved therein. RESPONSE TO REQUEST NO . 89: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence. In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to sales budgets, forecasts and milestones, that bear no relevance to any claim or defense in this action . Roche will therefore produce such documents only to the extent they relate to the factors considered in a preliminary or permanent injunction determination should those issues arise . To the extent Amgen seeks remedies beyond injunctive relief, Roche reserves the right to supplement its response to this Request. Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. 31362550 v23 .DOC 52 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 14 of 41 REQUEST NO . 90: All documents and things that comprise or relate to any forecast or projection of MIRCERA sales in the United States during 2006, 2007 and/or 2008 or any portion thereof, including all documents forecasting sales by territory, patient use or customer segment. RESPONSE TO REQUEST NO . 90: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence. In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to sales forecasts and projections, that bear no relevance to any claim or defense in this action. Roche will therefore produce such documents only to the extent they relate to the factors considered in a preliminary or permanent injunction determination should those issues arise . To the extent Amgen seeks remedies beyond injunctive relief, Roche reserves the right to supplement its response to this Request. Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REQUEST NO. 91: All documents and things relating to any solicitation, recruitment or hiring of sales personnel, medical liaisons or reimbursement specialists whose duties include promotion or support of MIRCERA, including any budget, plan, or forecast of hiring positions and levels. RESPONSE TO REQUEST NO . 91: Roche objects to this Request as overly broad, unduly burdensome, vague, ambiguous, harassing and not reasonably calculated to lead to the discovery of admissible evidence. 31362550_V23 .DOC 53 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 15 of 41 In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to sales and reimbursement, that bear no relevance to any claim or defense in this action. Moreover, Roche objects to this Request as any solicitation, recruitment and hiring of sales personnel, medical liaisons and reimbursement specialists bears no relevance to any claim or defense in this action. REOUEST NO . 92: All documents and things relating to any training or instruction of sales personnel, medical liaisons or reimbursement specialists regarding the forecasting, budget, marketing, promotion, contracting, use, pricing, dosing, and/or reimbursement of MIRCERA, including all such instructional materials provided to or used with such individuals. RESPONSE TO REQUEST NO. 92: Roche objects to this Request as overly broad, unduly burdensome, vague, ambiguous, harassing and not reasonably calculated to lead to the discovery of admissible evidence . In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to sales, forecasting, budgeting, marketing, pricing and reimbursement, that bear no relevance to any claim or defense in this action . Moreover, Roche objects to this Request as any training and instruction of sales personnel, medical liaisons and reimbursement specialists bears no relevance to any claim or defense in this action. REQUEST NO . 93: All manuals, sales forms, sales contact forms, forecasts, quotas, and tracking documents used by ROCHE to train its personnel to market, sell and/or obtain reimbursement of MIRCERA in the United States. 31362550_V23 .DOC 54 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 16 of 41 RESPONSE TO REQUEST NO . 93: Roche objects to this Request as overly broad, unduly burdensome, vague, ambiguous, harassing and not reasonably calculated to lead to the discovery of admissible evidence. In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to sales, forecasts and quotas, that bear no relevance to any claim or defense in this action . Moreover, Roche objects to this Request as any training and instruction of sales, marketing and reimbursement personnel bears no relevance to any claim or defense in this action. REQUEST NO . 94: All documents and things relating to any training or instruction of physicians, nurses, patients, clinic administrators, reimbursement authorities or other customers regarding the promotion, contracting, training, use, pricing, dosing, and/or reimbursement of MIRCERA use, including all such instructional materials provided to or used with such individuals. RESPONSE TO REQUEST NO. 94: Roche objects to this Request as overly broad, unduly burdensome, vague, ambiguous, harassing and not reasonably calculated to lead to the discovery of admissible evidence . In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to pricing, promotion and reimbursement, that bear no relevance to any claim or defense in this action . Moreover, Roche objects to this Request as any training and instruction of physicians, nurses, patients, clinic administrators, reimbursement authorities and other customers bears no relevance to any claim or defense in this action. REQUEST NO. 95: All documents and things relating to any communication, meeting, presentation or solicitation between ROCHE and any purchaser or consumer of ESP products (including any dialysis care organizations, hospitals, nephrology clinics, nephrologists, dialysis nurses, group purchasing organizations, the Veterans Administration, the Department of Defense and other 31362550 V23 .DOC 55 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 17 of 41 governmental organizations) relating to the current or future purchase, pricing, use or reimbursement of peg-EPO or MIRCERA in the United States. RESPONSE TO REQUEST NO . 95: Roche objects to this Request as overly broad, unduly burdensome, vague, ambiguous, harassing, duplicative, cumulative and not reasonably calculated to lead to the discovery of admissible evidence . Roche also objects to this Request's use of the term "peg-EPO" as vague, ambiguous and misleading . Roche objects to this Request to the extent it seeks documents, things and information protected from disclosure by third party confidentiality agreements . In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to pricing and reimbursement, that bear no relevance to any claim or defense in this action. REOUEST NO . 96: All documents and things relating to any monthly or other report or summary of activities relating to MIRCERA during any period since October 1, 2005 of any ROCHE sales director, sales manager, sales representative, medical liaison, or member of any marketing, sales, brand, medical affairs or governmental affairs team or group. RESPONSE TO REQUEST NO . 96: Roche objects to this Request as overly broad, unduly burdensome, vague, ambiguous, harassing and not reasonably calculated to lead to the discovery of admissible evidence . In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to sales and marketing, that bear no relevance to any claim or defense in this action. REQUEST NO. 97: Documents and things sufficient to show the most current quota or forecast of MIRCERA sales by month, quarter and year for each sales territory and region in the United States and its possessions during 2006, 2007 and 2008. 31362550 V23 .DOC 56 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 18 of 41 RESPONSE TO REQUEST NO . 97: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence. In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to sales quotas and forecasts, that bear no relevance to any claim or defense in this action . Roche will therefore produce such documents only to the extent they relate to the factors considered in a preliminary or permanent injunction determination should those issues arise . To the extent Amgen seeks remedies beyond injunctive relief, Roche reserves the right to supplement its response to this Request. Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REQUEST NO. 98: Documents and things sufficient to show the most current quota or forecast of MIRCERA sales by month, quarter and year for each customer in the United States and its possessions during 2006, 2007 and 2008. RESPONSE TO REQUEST NO . 98: Roche incorporates herein by reference its Response to Request No . 97 above. REQUEST NO . 99: Documents and things sufficient to show the policy and method by which sales of MIRCERA in the United States will affect the compensation of members of ROCHE's sales force, medical liaison, and medical affairs personnel. 31362550 v23 .DOC 57 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 19 of 41 RESPONSE TO REQUEST NO . 99: Roche objects to this Request as overly broad, unduly burdensome, vague, ambiguous, harassing and not reasonably calculated to lead to the discovery of admissible evidence . In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to sales, that bear no relevance to any claim or defense in this action . Moreover, Roche objects to this Request as the compensation of members of ROCHE's sales force, medical liaison and medical affairs personnel bears no relevance to any claim or defense in this action. REQUEST NO . 100: All documents and things relating to any customer or potential customer for peg-EPO, including large dialysis organizations, small dialysis organizations, group purchasing organizations, hospital-based dialysis centers, government pharmacies, individual clinics, and/or individual physicians, but excluding patient specific information, relating to the importation, use, offer for sale, sale or reimbursement of peg-EPO in the United States. RESPONSE TO REQUEST NO . 100: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request's use of the term "peg-EPO" as vague, ambiguous and misleading. Roche also objects to this Request to the extent it seeks documents, things and information protected from disclosure by third party confidentiality agreements . Moreover, Roche objects to this Request as seeking documents and information relevant only to issues relating to 35 U .S .C. § 271(e)(1) that were the subject of ITC Investigation No . 337-TA-568 that are no longer in issue in this action to the extent it refers to importation and related areas . To the extent any of these areas are relevant to any issue in this action, Roche refers Amgen to Roche's production from the ITC investigation for documents responsive to this Request. 31362550 V23 .DOC 58 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 20 of 41 In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to sales and reimbursement, that bear no relevance to any claim or defense in this action . Roche will therefore produce such documents only to the extent they relate to the factors considered in a preliminary or permanent injunction determination should those issues arise . To the extent Amgen seeks remedies beyond injunctive relief, Roche reserves the right to supplement its response to this Request. Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REQUEST NO. 101: All documents and things relating to any communication between ROCHE and any customer or potential customer for peg-EPO, including large dialysis organizations, small dialysis organizations, group purchasing organizations, hospital-based dialysis centers, government pharmacies, individual clinics, and/or individual physicians, but excluding patient specific information, relating to the importation, use, offer to sell, sale or reimbursement of pegEPO in the United States. RESPONSE TO REOUEST NO . 101: Roche incorporates herein by reference its Response to Request No . 100 above. REQUEST NO. 102: All documents and thing relating to any negotiation between ROCHE and any customer or potential customer for peg-EPO, including large dialysis organizations, small dialysis organizations, group purchasing organizations, hospital-based dialysis centers, government pharmacies, individual clinics, and/or individual physicians relating to the importation, use, offer to sell, sale or reimbursement of peg-EPO in the United States. 31362550 V23 .DOC 59 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 21 of 41 RESPONSE TO REOUEST NO . 102: Roche objects to this Request's use of the term "negotiation" as vague and ambiguous. Roche incorporates herein by reference its Response to Request No . 100 above. REQUEST NO . 103: All documents and things relating to any agreement or contract between ROCHE and any customer or potential customer for peg-EPO in the United States, including but not limited to large dialysis organizations, small dialysis organizations, group purchasing organizations, hospital-based dialysis centers, government pharmacies, individual clinics, and/or individual physicians, relating to the importation, use, offer to sell, sale, or reimbursement of peg-EPO in the United States. RESPONSE TO REOUEST NO . 103: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request's use of the term "peg-EPO" as vague, ambiguous and misleading. Roche also objects to this Request to the extent it seeks documents, things and information protected from disclosure by third party confidentiality agreements . Moreover, Roche objects to this Request as seeking documents and information relevant only to issues relating to 35 U .S .C. § 271(e)(1) that were the subject of ITC Investigation No . 337-TA-568 that are no longer in issue in this action to the extent it refers to importation and related areas. In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to sales and reimbursement, that bear no relevance to any claim or defense in this action . To the extent Amgen seeks remedies beyond injunctive relief, Roche reserves the right to supplement its response to this Request. . To Roche's current knowledge, no documents or things responsive to this Request exist. 31362550_V23 .DOC 60 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 22 of 41 REOUEST NO . 104: Documents and things sufficient to show all communications between ROCHE and DaVita Inc . or its affiliates relating to peg-EPO or any other ESP. RESPONSE TO REQUEST NO . 104: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request's use of the term "peg-EPO" as vague, ambiguous and misleading. Moreover, Roche objects to this Request to the extent it seeks documents, things and information protected from disclosure by third party confidentiality agreements. Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REOUEST NO. 105: Documents and things sufficient to show all communications between ROCHE and Dialysis Clinic Inc. (DCI) or its affiliates relating to peg-EPO or any other ESP. RESPONSE TO REQUEST NO . 105: Roche incorporates herein by reference its Response to Request No . 104 above. REQUEST NO. 106: Documents and things sufficient to show all communications between ROCHE and Fresenius Medical Care North America or Fresenius Medical Care AG & Co . KGaA or their affiliates relating to peg-EPO or any other ESP. RESPONSE TO REQUEST NO . 106: Roche incorporates herein by reference its Response to Request No . 104 above. 31362550_V23 .DOC 61 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 23 of 41 REQUEST NO . 107: Documents and things sufficient to show all communications between ROCHE and Gambro AG or its affiliates relating to peg-EPO or any other ESP. RESPONSE TO REQUEST NO . 107: Roche incorporates herein by reference its Response to Request No . 104 above. REQUEST NO. 108: Documents and things sufficient to show all communications between ROCHE and Renal Care Group, Inc . (RCG) or its affiliates relating to peg-EPO or any other ESP. RESPONSE TO REQUEST NO . 108: Roche incorporates herein by reference its Response to Request No . 104 above. REQUEST NO . 109: Documents and things sufficient to show all communications between ROCHE and any agency or procurement office of the United States Department of Defense, Veterans Administration or other governmental procurement office relating to peg-EPO or any other ESP. RESPONSE TO REQUEST NO. 109: Roche incorporates herein by reference its Response to Request No . 104 above. REQUEST NO . 110: All documents and things relating to any agreement, assignment, license, or transfer between ROCHE and a third party in the United States regarding any ESP potentially useful in the treatment of anemia. RESPONSE TO REQUEST NO . 110: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request to the extent it seeks documents, things and information protected from disclosure by third party confidentiality agreements . Roche also objects to this Request as overly broad and seeking information not relevant to any claim or defense in this action to the extent it refers to "any ESP" other than MIRCERA TM 31362550 V23 .DOC 62 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 24 of 41 In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to licenses or assignments, that bear no relevance to any claim or defense in this action . Roche will therefore produce such documents only to the extent they relate to the factors considered in a preliminary or permanent injunction determination should those issues arise . To the extent Amgen seeks remedies beyond injunctive relief, Roche reserves the right to supplement its response to this Request. Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REQUEST NO. 111: All documents and things relating to any executed or proposed understanding or agreement between ROCHE and any third party relating to any past, current or future use of pegEPO or EPO in the United States. RESPONSE TO REOUEST NO . 111: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request's use of the term "peg-EPO" as vague, ambiguous and misleading. Roche also objects to this Request as seeking documents and things that have no relevance to any claim or defense in this action as EPO is not the accused product in this case . Moreover, Roche objects to this Request to the extent it seeks documents, things and information protected from disclosure by third party confidentiality agreements. 31362550_V23 .DOC 63 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 25 of 41 In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating potentially to licenses or assignments, that bear no relevance to any claim or defense in this action . Roche will therefore produce such documents only to the extent they relate to the factors considered in a preliminary or permanent injunction determination should those issues arise . To the extent Amgen seeks remedies beyond injunctive relief, Roche reserves the right to supplement its response to this Request. Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REQUEST NO . 112: All documents and things relating to any executed or proposed understanding or agreement between any of the ROCHE entities relating to any past, current or future use of pegEPO or EPO in the United States. RESPONSE TO REQUEST NO . 112: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request's use of the term "peg-EPO" as vague, ambiguous and misleading. Moreover, Roche objects to this Request as seeking documents and things that have no relevance to any claim or defense in this action as EPO is not the accused product in this case . Roche further objects to this Request as seeking documents and information relevant only to issues relating to 35 U .S .C . § 271(e)(1) that were the subject of ITC Investigation No . 337-TA-568 that 31362550 v23 .DOC 64 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 26 of 41 are no longer in issue in this action to the extent it relates to internal transfer of MIRCERA TM and related areas. REOUEST NO. 113: All documents and things relating to any offer to provide peg-EPO or EPO for use in the United States to any person or entity for any purpose or use that is not related to the development and submission of information to FDA under a federal law regulates the manufacture, use, or sale of erythropoietin products. RESPONSE TO REQUEST NO . 113: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request's use of the term "peg-EPO" as vague, ambiguous and misleading. Roche also objects to this Request as seeking documents and things that have no relevance to any claim or defense in this action as EPO is not the accused product in this case . Moreover, to Roche's current knowledge, no documents or things responsive to this Request exist. REOUEST NO . 114: All documents and things relating to any offer to sell peg-EPO or EPO to any person or entity for any use in the United States not related to the development and submission of information to FDA under a federal law that regulates the manufacture, use, or sale of peg-EPO or EPO products. RESPONSE TO REOUEST NO . 114: Roche incorporates herein by reference its Response to Request No . 113 above. REOUEST NO . 115: All documents and things relating to any agreement or understanding to sell, supply or provide peg-EPO or EPO for use in the United States at any time after FDA approval of ROCHE's pending BLA. RESPONSE TO REOUEST NO . 115: Roche incorporates herein by reference its Response to Request No . 113 above. 31362550_V23 .DOC 65 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 27 of 41 REQUEST NO . 116: All documents and things related to the recruitment, solicitation or hiring of any Amgen employee by ROCHE since January 1, 2004. RESPONSE TO REQUEST NO . 116: Roche objects to this Request as overly broad, unduly burdensome, vague, ambiguous, harassing and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request as relating to the recruitment, solicitation and hiring of Amgen employees by Roche and therefore seeking documents and things bearing no relevance to any claim or defense in this action. REQUEST NO . 117: All documents and things related to any plan or budget of ROCHE to recruit, solicit or hire Amgen sales personnel, medical liaisons, reimbursement specialists or marketing personnel. RESPONSE TO REQUEST NO . 117: Roche objects to this Request as overly broad, unduly burdensome, vague, ambiguous, harassing and not reasonably calculated to lead to the discovery of admissible evidence . In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to sales, marketing and reimbursement, that bear no relevance to any claim or defense in this action . Moreover, Roche objects to this Request as relating to the recruitment, solicitation and hiring of Amgen employees by Roche and therefore seeking documents and things bearing no relevance to any claim or defense in this action. REOUEST NO. 118: All documents and things related to any communication between ROCHE and any third party regarding recruitment, solicitation or hiring of any Amgen employee for employment by ROCHE since January 1, 2004. 31362550_V23 .DOC 66 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 28 of 41 RESPONSE TO REOUEST NO . 118: Roche objects to this Request as overly broad, unduly burdensome, vague, ambiguous, harassing and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request to the extent it seeks documents, things and information protected from disclosure by third party confidentiality agreements . Moreover, Roche objects to this Request as relating to the recruitment, solicitation and hiring of Amgen employees by Roche and therefore seeking documents and things bearing no relevance to any claim or defense in this action. REQUEST NO . 119: All documents and things related to any listing, directory or other information of Amgen regarding its employees, business dealings, customers or internal organization. RESPONSE TO REOUEST NO. 119: Roche objects to this Request as overly broad, unduly burdensome, vague, ambiguous, harassing and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request as relating to the employees, customers and internal organization of Amgen and therefore seeking documents and things bearing no relevance to any claim or defense in this action. REQUEST NO. 120: All documents and things related to any listing, directory or other information of Amgen regarding its employees, business dealings, customers or internal organization. RESPONSE TO REQUEST NO . 120: Roche incorporates herein by reference its Response to Request No . 119 above. REQUEST NO. 121: All documents and things relating to information of Amgen regarding its instruction, training, organization, supervision or compensation of its employees, including manuals, directories, forms, reports and spreadsheets. 31362550_V23 .DOC 67 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 29 of 41 RESPONSE TO REQUEST NO . 121: Roche objects to this Request as overly broad, unduly burdensome, vague, ambiguous, harassing and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request as relating to the instruction, training, organization, supervision and compensation of Amgen employees and therefore seeking documents and things bearing no relevance to any claim or defense in this action. REQUEST NO . 122: All documents and things relating to information of Amgen regarding its instruction, training or support of customers or reimbursement personnel. RESPONSE TO REQUEST NO . 122: Roche objects to this Request as overly broad, unduly burdensome, vague, ambiguous, harassing and not reasonably calculated to lead to the discovery of admissible evidence . In light of Amgen's current position that it does not seek relief in the form of damages, this Request is of unreasonable scope and seeks documents and things, relating particularly to reimbursement, that bear no relevance to any claim or defense in this action . Moreover, Roche objects to this Request as relating to the instruction, training or support of Amgen customers and reimbursement personnel and therefore seeking documents and things bearing no relevance to any claim or defense in this action. REQUEST NO . 123: Documents and things sufficient to identify and describe all activities sponsored by ROCHE since January 1, 2005 to enhance the competitive profile of peg-EPO. RESPONSE TO REQUEST NO . 123: Roche objects to this Request as overly broad, unduly burdensome, vague, ambiguous, and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request's use of the term "peg-EPO" as vague, ambiguous and misleading . Roche objects 31362550_V23 .DOC 68 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 30 of 41 to this Request's use of the term "enhance the competitive profile" as it is vague, ambiguous and undefined. REQUEST NO. 124: Documents and things sufficient to identify and describe each clinical use or study of peg-EPO in the United States (excluding patient-specific information) after April 19, 2006, including the identity and location of each facility, the sponsor administering drug and the clinical protocol pursuant to which such administration was, is or will be made. RESPONSE TO REQUEST NO. 124: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request's use of the term "peg-EPO" as vague, ambiguous and misleading. Roche refers Amgen to Roche's No . STN 125164/0 and IND Nos . BB-IND 10158 and BB-IND 10964, already produced to Amgen in ITC Investigation No . 337-TA-568, for information concerning the clinical use and study of MIRCERA TM . Subject to these objections and the General Responses and Objections above, relevant, non-duplicative, non-cumulative documents relating to any completed communications, updates, amendments or supplements to Roche's BLA No . STN 125164/0 and INDs Nos . BB-IND 10158 and BB-IND 10964 and the final results of any completed studies or protocols underlying these submissions, which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REQUEST NO. 125: All documents and things related to any plan, study protocol, draft protocol, concept, schedule, budget or supply forecast for use of peg-EPO in humans in the United States for any study not included in ROCHE's April 19, 2006 Biologics License Application, including any "Phase IIIb/IV" study. 31362550_V23 .D0C 69 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 31 of 41 RESPONSE TO REQUEST NO . 125: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request's use of the term "peg-EPO" as vague, ambiguous and misleading. Subject to these objections and the General Responses and Objections above, relevant, non-duplicative, non-cumulative documents relating to any completed communications, updates, amendments or supplements to Roche's BLA No . STN 125164/0 and INDs Nos . BB-IND 10158 and BB-IND 10964, and the final results of any completed studies or protocols underlying these submissions, which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REQUEST NO. 126: All documents and things comprising or related to any communication or presentation after January 1, 2006 between ROCHE and any third party (including all communications with clinicians and investigational review boards) regarding any plan, study protocol, draft protocol, concept, schedule or budget to study the use of peg-EPO in anemic renal patients in the United States, including any "Phase IIIb/IV" study. RESPONSE TO REQUEST NO . 126: Roche incorporates herein by reference its Response to Request No . 125 above. REQUEST NO. 127: All documents and things related to the conception, development, budget, cost, funding for, work performed, results, or presentation of the information contained in Abstract Nos . THP0072, TH,-P0230, TH-P0359, TH-P0361, TH-PO1001, TH-PO1002, TH-PO1007, PUB376, PUB377, F-P0375, F-PO408, F-P0671, F-P0685, SA-P0019, SA-P0034, SA-P0035, SAP0192, SA-PO197, SA-PO198, SA-P0205, SA-P0207, SA-P0208, SA-P0209, SA-P0210, SA-P0212, and SA-P0225 (attached hereto as Exhibit B), as submitted for publication in 2006 to the American Society of Nephrology. 31362550_V23 .DOC 70 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 32 of 41 RESPONSE TO REQUEST NO . 127: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence. Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REQUEST NO . 128: All documents and things comprising or related to any communication or presentation between ROCHE and any third parry (including all communications with clinicians and investigational review boards) regarding Abstract No . SA-P0205 (Exhibit C), including all drafts of the study protocol. RESPONSE TO REQUEST NO . 128: Roche incorporates herein by reference its Response to Request No . 127 above. REOUEST NO. 129: All documents and things relating to the use of control variables in the development of a case-mix adjusted payment system for dialysis systems, as described in ASN Abstract THPO 1007 (attached hereto as Exhibit D). RESPONSE TO REQUEST NO . 129: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request as seeking documents and things unrelated to MIRCERA TM and having no relevance to any claim or defense in this action . Moreover, Roche objects to this Request's use of the term "case-mix adjusted payment system for dialysis systems" as vague, ambiguous, 31362550_V23 .DOC 71 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 33 of 41 indeterminate and seeking information irrelevant in light of Amgen's absence of any damages claim. REOUEST NO. 130: All documents and things relating to any communication between ROCHE and J. Wheeler, M. Turenne, R . Hirth, J. Messana, or A. Pozniak regarding any study or investigation of the use of control variables in the development of a case-mix adjusted payment system for dialysis systems, as described in the previous request for production. RESPONSE TO REOUEST NO . 130: Roche incorporates herein by reference its Response to Request No . 129 above. REOUEST NO . 131: All documents and things relating to any association between missed dialysis sessions and hemoglobin variability, as described in ASN Abstract F-P0375 (attached hereto as Exhibit E). RESPONSE TO REOUEST NO. 131: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence. Subject to these objections and the General Responses and Objections above, relevant, non-cumulative documents responsive to this Request which are in Roche's possession, custody or control and which are not subject to a claim of privilege or work product immunity or otherwise protected from disclosure, will be produced or made available for inspection and copying. REOUEST NO. 132: All documents and things relating to any communication between ROCHE and Robert N. Foley, Qi Li, David T . Gilbertson, Allan J . Collins, or Stephan C . Dunning regarding any study or investigation of any association between missed dialysis sessions and hemoglobin variability, as described in the previous request for production. RESPONSE TO REOUEST NO . 132: Roche incorporates herein by reference its Response to Request No . 131 above. 31362550_V23 .DOC 72 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 34 of 41 REQUEST NO . 133: All documents and things relating to any association of persistently low hemoglobin levels with medical expenditures in dialysis patients, as described in ASN Abstract F-PO408 (attached hereto as Exhibit F). RESPONSE TO REQUEST NO. 133: See Response to Request No . 131 above. REQUEST NO . 134: All documents and things relating to any communication between ROCHE and Jiannong Liu, Haifeng Guo, David T. Gilbertson, or Allan J. Collins, regarding any study or investigation of any association of persistently low hemoglobin levels with medical expenditures in dialysis patients, as described in the previous request for production. RESPONSE TO REQUEST NO . 134: Roche incorporates herein by reference its Response to Request No . 131 above. REOUEST NO. 135: All documents and things relating to any association between hemoglobin variability and mortality among dialysis patients, as described in ASN Abstract SA-P0034 or SA-P0035 (attached hereto as Exhibits G and H). RESPONSE TO REQUEST NO. 135: Roche incorporates herein by reference its Response to Request No . 131 above. REQUEST NO . 136: All documents and things relating to any communication between ROCHE and H .I. Feldman, R.K. Israni, W . Yang, S . Fishbane, or M. Joffe regarding any study or investigation of any association between hemoglobin variability and mortality among dialysis patients, as described in the previous request for production. RESPONSE TO REQUEST NO . 136: Roche incorporates herein by reference its Response to Request No . 131 above. REOUEST NO . 137: For each clinical trial involving peg-EPO, a copy of the study protocol, investigator brochure and material transfer agreement. 31362550_V23 .DOC 73 Case 1:05-cv-12237-WGY Document 177-4 Filed 12/15/2006 Page 35 of 41 RESPONSE TO REQUEST NO . 137: Roche objects to this Request to the extent it is overly broad, unduly burdensome, vague, ambiguous and not reasonably calculated to lead to the discovery of admissible evidence . Roche objects to this Request's use of the term "peg-EPO" as vague, ambiguous and misleading. Roche refers Amgen to Roche's BLA No . STN 125164/0 already produced to Amgen in ITC Investigation No . 337-TA-568 for information responsive to this Request . Roche also objects to this Request to the extent it seeks documents and things r

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