SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): June 19, 2003
IDEC PHARMACEUTICALS CORPORATION
(Exact name of registrant as specified in its charter)
Delaware |
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0-19311 |
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33-0112644 |
(State or other
jurisdiction of |
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(Commission File Number) |
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(IRS Employer Identification No.) |
3030 Callan Road, San Diego, CA |
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92121 |
(Address of principal executive offices) |
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(Zip Code) |
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Registrants telephone number, including area code: (858) 431-8500 |
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N/A |
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(Former name or former address, if changed since last report) |
Item 5. Other Events
On Friday, June 20, 2003, IDEC Pharmaceuticals Corporation and Genentech, Inc. announced that they had entered into an amended and restated collaboration agreement dated as of June 19, 2003 (the Collaboration Agreement) to develop one or more new humanized anti-CD20 antibodies targeting B-cell disorders for a broad range of indications. The Collaboration Agreement is attached hereto as Exhibit 99.1 and is incorporated herein by reference. The press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits
(a) Not applicable
(b) Not applicable
(c) Exhibits
* Exhibit 99.1 Amended and Restated Collaboration Agreement dated June 19, 2003
Exhibit 99.2 Press Release dated June 20, 2003
* The Registrant has applied for Confidential Treatment with respect to portions of this Exhibit.
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SIGNATURE
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: July 31, 2003
IDEC PHARMACEUTICALS CORPORATION |
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By: |
/s/ John M. Dunn |
Name: |
John M. Dunn |
Title: |
Senior Vice President and General Counsel |
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Exhibit 99.1
CONFIDENTIAL TREATMENT
CONFIDENTIAL TREATMENT REQUESTED: INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND IS NOTED WITH "[CONFIDENTIAL TREATMENT REQUESTED]." AN UNREDACTED VERSION OF THIS DOCUMENT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
AMENDED AND RESTATED
COLLABORATION AGREEMENT
GENENTECH, INC. AND
IDEC PHARMACEUTICALS CORPORATION
CONFIDENTIAL TREATMENT
COLLABORATION AGREEMENT
THIS AMENDED AND RESTATED COLLABORATION AGREEMENT (this Agreement) is made effective as of the 19th day of June, 2003 (the Restated Effective Date) by and between IDEC Pharmaceuticals Corporation, a Delaware corporation having its principal place of business at 3030 Callan Road, San Diego, California 92121 (IDEC) and GENENTECH, INC., a Delaware corporation having its principal place of business at 1 DNA Way, South San Francisco, California 94080 (Genentech), each on behalf of itself and its Affiliates. IDEC and Genentech are sometimes referred to herein individually as a Party and collectively as the Parties, and references to IDEC and Genentech shall include their respective Affiliates.
RECITALS
1. Genentech and IDEC entered into that certain Collaboration Agreement dated as of March 16, 1995 related to the development and commercialization of Licensed Products, including without limitation C2B8 (the Original Agreement).
2. In the Original Agreement, IDEC granted to Genentech, and Genentech obtained, rights to co-promote Licensed Products in the United States and Canada and to develop and market Licensed Products in the rest of the world (excluding certain Asian countries, which were added to the Original Agreement by amendment at a later date).
3. Simultaneously with the execution of the Original Agreement, IDEC and Genentech entered into a Preferred Stock Purchase Agreement (the Stock Purchase Agreement) of even date therewith, pursuant to which Genentech purchased $5 million of Preferred Stock of IDEC in accordance with the terms and conditions thereof.
4. Simultaneously with the execution of the Original Agreement, IDEC and Genentech entered into the Expression Technology License of even date therewith granting Genentech rights to certain enabling technology (the Expression Technology License).
5. Following the execution of the Original Agreement, the Parties entered into a first amendment to the Collaboration Agreement of November 30, 1995 (the First Amendment) expanding Genentechs rights to develop and market Licensed Products in the world to include certain Asian countries.
6. Following the execution of the Original Agreement, the parties entered into an amendment of June 15, 1998 (the Second Amendment) approving the assignment of certain rights of Genentech in Canada with respect to C2B8 to F. Hoffmann La Roche Ltd.
7. The Parties desire to amend and restate the Original Agreement to include certain additional products (New Products, as defined below) whose mechanism of action is initiated by interaction with the CD20 B-cell determinant, including without limitation the humanized molecule created by Genentech known as G2H7, in each case on the terms and subject to the conditions set forth in this Agreement.
CONFIDENTIAL TREATMENT
8. In an effort to be efficient in the drafting of this Agreement, the Parties have elected to preserve substantial portions of the historical content of the Original Agreement, the First Amendment and the Second Amendment in this Agreement (with the expressed understanding that such content is not given any renewed or additional meaning by its inclusion herein).
9. The Parties desire to coordinate the commercial efforts related to Licensed Products with the development efforts related to New Products, and subsequently to synchronize the commercial efforts and financial treatment of all Licensed Products and New Products marketed by the Parties in the Co-Promotion Territory.
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
Capitalized terms not otherwise defined herein have the meaning given them in the Schedule of Master Definitions attached hereto as Appendix 1.
2.1 Initial Licensed Product. The Parties will focus their initial efforts on the development of C2B8 in the Field.
2.2 [CONFIDENTIAL TREATMENT REQUESTED] Option and Phase II Trial. If IDEC decides, or the Parties mutually agree, to commence a Phase II Clinical Trial of IDECs [CONFIDENTIAL TREATMENT REQUESTED] and IDECs [CONFIDENTIAL TREATMENT REQUESTED] (the Y2B8 Phase II Trial), IDEC shall give notice, including the number of evaluable patients, of such proposed Y2B8 Phase II Trial (the Y2B8 Phase II Notice) to Genentech. If Genentech notifies IDEC within sixty (60) days of receipt of the Y2B8 Phase II Notice that it intends to participate with IDEC in the Y2B8 Phase II Trial, then Genentech shall bear [CONFIDENTIAL TREATMENT REQUESTED] of the costs of the Y2B8 Phase II Trial up to a maximum Genentech contribution of [CONFIDENTIAL TREATMENT REQUESTED]. Once Genentech has reached its maximum contribution, [CONFIDENTIAL TREATMENT REQUESTED] for the Y2B8 Phase II Trial in excess of this amount shall be borne [CONFIDENTIAL TREATMENT REQUESTED] by IDEC. If IDEC does not receive timely notice from Genentech of its intention to participate in the Y2B8 Phase II Trial, then IDEC may proceed with the Y2B8 Phase II Trial provided that IDEC shall bear the cost of the Y2B8 Phase II Trial. Upon completion of the Y2B8 Phase II Trial and delivery to Genentech of a final report with respect thereto, Genentech shall have 120 days to exercise an option to include Y2B8 and In2B8 as Licensed Products (the Y2B8 Option). The Y2B8 Option shall be exercisable by written notice to IDEC (Notice of Y2B8/In2B8 Exercise) together with payment in the amount of [CONFIDENTIAL TREATMENT REQUESTED] (the Option Fee). Notwithstanding the foregoing, if Genentech shall have elected to participate with IDEC in the Y2B8 Phase II Trial and contribute up to [CONFIDENTIAL
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TREATMENT REQUESTED] toward the costs of such Y2B8 Phase II Trial, then the Option Fee shall be reduced to [CONFIDENTIAL TREATMENT REQUESTED]. Within 60 days of the Notice of Y2B8/1n2B Exercise, the Parties shall agree upon the terms and conditions governing the development and commercialization of products derived from Y2B8 and In2B8, taking into account the commercial value of Y2B8 and In2B relative to C2B8. In any event, no later than publication of the Pivotal Phase III Clinical Trial results of C2B8, the Parties shall discuss in good faith the initiation of the Y2B8 Phase II Trial.
2.4 Initial New Product. From and after the date of the payment in Section 7.1(b)(i), G2H7 shall be deemed a New Product, the development and commercialization of which shall be governed by this Agreement. Following the Restated Effective Date, the Parties shall focus their initial efforts with regard to New Products on the development of G2H7 in the Field in the Co-Promotion Territory.
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Notwithstanding anything to the contrary in this Agreement, it is understood and agreed that, with respect to [CONFIDENTIAL TREATMENT REQUESTED] Potential New Products for which IDEC has timely opted-in and paid the opt-in fee hereunder, Genentech is under no obligation under this Agreement to offer or grant to IDEC any rights to such [CONFIDENTIAL TREATMENT REQUESTED] Potential New Products outside the United States, or make any payments to IDEC with respect to Genentechs development and commercialization of such [CONFIDENTIAL TREATMENT REQUESTED] Potential New Products outside the United States.
Failure by IDEC under this Section 2.5(b) to provide a timely election notice or to timely pay the opt-in fee, or rejection by IDEC of a independent investment bankers determination of the amount of the opt-in fee (when provided in the manner set forth above with respect to [CONFIDENTIAL TREATMENT REQUESTED] Potential New Products), will be deemed to be an election not to participate in such Potential New Product (and following any such failure or rejection, Genentech shall (except as provided in Section 2.5(c) with respect to [CONFIDENTIAL TREATMENT REQUESTED] Potential New Products) have no further obligation to offer such Potential New Product to IDEC and IDEC shall have no further rights under this Agreement with respect to such Potential New Product).
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2.7 Development Costs for New Products. Unless otherwise agreed in writing by the Parties, from and after the Restated Effective Date, and notwithstanding a Partys share in Operating Profits (or Losses), all Development Costs for New Products for development or marketing in the Co-Promotion Territory shall be shared by the Parties, [CONFIDENTIAL TREATMENT REQUESTED] by Genentech and [CONFIDENTIAL TREATMENT REQUESTED] by IDEC until [CONFIDENTIAL TREATMENT REQUESTED]. After [CONFIDENTIAL TREATMENT REQUESTED], the Parties will share in the Development Costs for Franchise Products for development or marketing in the Co-Promotion Territory commensurate with the profit/loss sharing relationship specified in Section A.9.3 and the guidelines for charging costs specified in Section A.11 of Exhibit A for such products. Genentech shall bear [CONFIDENTIAL TREATMENT REQUESTED] Development Costs for New Products for development or marketing in the Licensed Territory, unless otherwise agreed in writing by the Parties.
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3.5 Collaboration Co-Chairpersons. Within sixty (60) days of the Restated Effective Date, each Party shall designate a Collaboration Co-Chairperson. Each such Collaboration Co-Chairperson shall be a vice president, unless otherwise agreed, and shall serve as a member or an ex-officio member of the Management Committee and each Operating Committee and shall be responsible (together, or as the Collaboration Co-Chairpersons may elect to divide responsibilities) to set the agenda of, call and take minutes of meetings of each Committee. In the event of any reasonable dispute between the Collaboration Co-Chairpersons as to any matter to include in the agenda of a meeting, such matter shall by default be included in the agenda.
4.1 Development Efforts for C2B8. IDEC and Genentech each agree to collaborate diligently in the development of C2B8 in the Field and to use commercially reasonable and diligent efforts to develop and bring C2B8 to market in the Field as soon as practicable. The Parties further agree to execute and substantially perform the Development Plan for C2B8 and to cooperate with the other in carrying out such Development Plan. Upon the entry of New Products into the development pipeline in accordance with Section 2.4 or 2.5, it is anticipated that the parties may elect to develop and commercialize one or more such New Product(s) in a manner that might adversely affect the development and/or commercialization of C2B8, but in any event such efforts shall be directed towards maximizing the Operating Profits of the Franchise Products in the aggregate. As used in this Agreement, the term commercially reasonable and diligent efforts will mean those efforts consistent with the exercise of prudent scientific and business judgment, as applied to other pharmaceutical products of similar potential and market size by the Party in question.
4.2 Drug Approval Applications for C2B8. Consistent with the Development Plan, IDEC (or Genentech, if appropriate) shall file Drug Approval Applications and seek Regulatory
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Approvals for C2B8 in the Co-Promotion Territory. Prior to submitting any Drug Approval Application, the Parties, through the JDC, shall consult, cooperate in preparing and mutually agree on such Applications and their content and scope. Each Party shall own all regulatory submissions including all Drug Approval Applications for C2B8 that such Party files in the Co-Promotion Territory. The Parties will endeavor to include on all package labels and inserts for C2B8 sold in the Co-Promotion Territory, where appropriate (i.e., to the extent such materials identify or otherwise make reference to either of the Parties), the names and logos of each of IDEC and Genentech with equal prominence, to the extent permitted by the applicable regulatory authorities.
4.3 Development Efforts for New Products. IDEC and Genentech each agree to collaborate diligently in the development of New Products in the Co-Promotion Territory in the Field and to use commercially reasonable and diligent efforts to develop and bring each New Product to market in the Co-Promotion Territory in the Field as soon as practicable so as to maximize the potential Operating Profits as to Franchise Products in the aggregate in the Co-Promotion Territory. The Parties further agree to execute and substantially perform the Development Plan for each New Product and to cooperate with the other in carrying out each such Development Plan.
4.4 Drug Approval Applications for New Products. Consistent with the Development Plans for New Products, unless otherwise agreed in writing, Genentech shall file Drug Approval Applications and seek Regulatory Approvals for New Products in the Co-Promotion Territory. Prior to submitting any Drug Approval Application, the Parties, through the JDC, shall consult, cooperate in preparing and mutually agree upon such Application and its content and scope. Each Party shall own all regulatory submissions including all Drug Approval Applications for New Products that such Party files in the Co-Promotion Territory. The Parties will endeavor to include on all package labels and inserts for New Products sold in the Co-Promotion Territory, when appropriate (i.e., to the extent such materials identify or otherwise make reference to either of the Parties), the names and logos of each of IDEC and Genentech with equal prominence, to the extent permitted by the applicable regulatory authorities.
4.5 Development Activities for Franchise Products. With regard to the development of New Products, including, without limitation, G2H7, and with regard to all Franchise Products (including, without limitation, C2B8) [CONFIDENTIAL TREATMENT REQUESTED], Genentech will be responsible for proposing strategic plans (including plans to initiate a company sponsored trial), as well as Development Plans, for such Franchise Products. Such Development Plans shall include, where appropriate and without limitation, clinical development plans, timelines, and overall budgets (consisting of aggregate estimated annual expenditures and top line expenses for clinical development) for such Franchise Products. Such strategic plans and Development Plans and other materials shall be delivered to the JDC for review and approval by unanimous consent. Once a Development Plan has been approved by the JDC, Genentech shall be responsible for implementing such Development Plans, except to the extent that the JDC allocates particular activities, by unanimous consent, to IDEC. In addition, and notwithstanding the dispute resolution provisions of Sections 3.1 through 3.4, with regard to the development of New Products, including without limitation G2H7, and with regard to all Franchise Products (including without limitation C2B8) [CONFIDENTIAL TREATMENT REQUESTED], Genentech shall have final decision-making control over the implementation of
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each such Development Plan, including without limitation, clinical development, provided, however, that Genentech shall not have the right to (i) exceed the annual aggregate budget approved with a Development Plan by [CONFIDENTIAL TREATMENT REQUESTED] without the unanimous approval of the JDC, (ii) assign tasks to IDEC that were not otherwise approved by unanimous consent of the JDC, or (iii) materially amend a Development Plan without the unanimous approval of the JDC. For the avoidance of doubt, it is understood and agreed that Genentechs implementation of a Development Plan shall not be deemed a material amendment to such Development Plan, unless such implementation would (x) materially modify the strategic direction agreed upon by the Parties thereunder, or (y) result in an agreed upon timeline thereunder being [CONFIDENTIAL TREATMENT REQUESTED].
4.6 Clinical Trials Not Approved by the JDC. In the event that Genentech proposes a particular clinical trial as part of a Development Plan (other than a clinical trial proposed for C2B8 prior to the First New Product FDA Approval ) and such trial is not approved by the JDC within thirty (30) days of the date that such trial was proposed to the JDC (or in the event such trial was proposed to the JDC other than at a meeting of the JDC, within thirty (30) days of the date that the JDC first meets (whether in person or by teleconference) following the date such trial was proposed to the JDC), then Genentech shall have the right to conduct such trial at its own expense. During such thirty (30) day period, Genentech shall timely provide all information reasonably requested by any member of the JDC that would be material to making a determination as whether such proposed clinical trial should be approved. If in such circumstance, Genentech elects to conduct such trial within a reasonable period of time thereafter, and such trial meets all of its primary endpoints, then IDEC shall reimburse Genentech for [CONFIDENTIAL TREATMENT REQUESTED] of the Development Costs related to such trial that IDEC would otherwise have been responsible for if the JDC had approved such trial (i.e., [CONFIDENTIAL TREATMENT REQUESTED] the total Development Costs).
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IDEC shall timely provide Genentech with invoices for any [CONFIDENTIAL TREATMENT REQUESTED] incurred under this Section 5.2(b), and Genentech shall pay such invoices within sixty (60) days thereof. Genentech shall have the right to audit such invoiced [CONFIDENTIAL TREATMENT REQUESTED] no more than once a calendar year, such audit to be conducted in accordance with Section A.6 of Exhibit A.
As used herein:
[CONFIDENTIAL TREATMENT REQUESTED];
[CONFIDENTIAL TREATMENT REQUESTED] means that number of additional incremental IDEC FTEs actually allocated by IDEC to its sales force in a given calendar year to convert a portion of such sales force to a sales force dedicated to selling [CONFIDENTIAL TREATMENT REQUESTED] (and to the extent IDEC elects to allocate any of such sales force dedicated to selling [CONFIDENTIAL TREATMENT REQUESTED] to also selling non-Franchise Products [CONFIDENTIAL TREATMENT REQUESTED], it is understood that [CONFIDENTIAL TREATMENT REQUESTED]; provided such FTEs shall not
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include that portion of any FTEs allocated by IDEC to selling [CONFIDENTIAL TREATMENT REQUESTED] prior to the date of Genentechs written notice to IDEC under Section 5.2(b)(i) above nor as of the Restated Effective Date;
FTE means the equivalent of a full-time employee (or [CONFIDENTIAL TREATMENT REQUESTED]) assigned to selling, supporting or overseeing the sale activity of [CONFIDENTIAL TREATMENT REQUESTED] in the Co-Promotion Territory over a calendar year (including normal vacation, sick days and holidays), and in the case of less than a full-time employee (or [CONFIDENTIAL TREATMENT REQUESTED]), the portion of an FTE year devoted by an employee (or [CONFIDENTIAL TREATMENT REQUESTED]) to the [CONFIDENTIAL TREATMENT REQUESTED] sales force shall be determined by dividing the number of days (or partial days) during any calendar year devoted by such employee (or [CONFIDENTIAL TREATMENT REQUESTED]) to the [CONFIDENTIAL TREATMENT REQUESTED] sales force by the total number of working days of a full-time employee (or [CONFIDENTIAL TREATMENT REQUESTED]) during such calendar year; and
FTE Rate means [CONFIDENTIAL TREATMENT REQUESTED] per FTE per calendar year.
5.3 Sales and Distribution. Unless otherwise agreed in writing, Genentech shall have the sole responsibility with respect to the following:
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5.5 Training Program. Genentech shall develop training programs relating to Franchise Products for the sales forces of each respective Party and for any Third Parties engaged in selling or promotion, and shall assign responsibility to itself, IDEC or a Third Party for the preparation of materials and conduct of training. The Parties agree to utilize such training programs on an ongoing basis to assure a consistent, focused promotional strategy. The initial training as to any Franchise Product shall be carried out at a time which is mutually acceptable to the Parties, and which is prior to but reasonably near the date on which the first Regulatory Approval for such Franchise Product is expected in the Co-Promotion Territory. As additional members are added to the Parties respective sales forces, training will be given to groups of the newly selected members.
6.1 Development Efforts. Genentech will use commercially reasonable and diligent efforts to develop C2B8, including pursuing preclinical development and clinical development of C2B8 and obtaining Regulatory Approvals therefor in all countries in the Licensed Territory, taking into account the scientific and commercial potential of C2B8, including, without limitation, each of the potential indications in the Field for C2B8. Within ninety (90) days of the Original Effective Date, Genentech agrees to provide IDEC with a written development strategy for C2B8 in the Licensed Territory indicating (i) whether Genentech will develop C2B8 alone or with a partner in Europe, (ii) the identity of its European partner (if any), and (iii) a list of clinical trials which Genentech would conduct for C2B8 approval in Europe assuming adequate quantities of C2B8 are available.
6.2 Marketing Efforts. Genentech will use commercially reasonable and diligent efforts to commercialize C2B8 in each country in which Regulatory Approval is granted, taking into account the scientific and commercial potential for C2B8, including without limitation each of the potential indications therefor.
6.3 Development Costs and Marketing Costs. Genentech shall bear all Development Costs and Marketing Costs for C2B8 for development or marketing in the Licensed Territory. Genentech shall have the sole responsibility for, and right to make all decisions regarding, all development and marketing activities in the Licensed Territory.
6.4 Cooperation on Development Efforts. To facilitate cooperation between the Parties on the worldwide development and marketing of C2B8, Genentech shall keep IDEC informed of all substantive development activities in the Licensed Territory, and agrees to use its good faith efforts to have an IDEC representative attend meetings of any development committee or similar body governing development activities of Licensed Products in the Licensed Territory. Genentech shall consider in good faith any comments made by such IDEC representative. The
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Parties agree that they will do nothing during C2B8 development activities to imperil early Regulatory Approvals in any country in any territory. Genentech further agrees that its European development plan for Licensed Products will not specify clinical trials on a time line that would delay or slow Regulatory Approval in the United States.
7.1 (a) Payments by Genentech upon Execution of Original Agreement. Genentech made the following payments to IDEC at the times set forth herein or in the operative agreement:
7.2 Additional Equity Purchases. Genentech shall make certain additional equity purchases in accordance with the terms and conditions of the Stock Purchase Agreement.
7.3 Special Pre-Approval Debt or Equity Purchase. Genentech shall, at the election of IDEC, make an additional investment or loan in accordance with the terms and conditions of an Option Agreement of even date of the Original Effective Date between IDEC and Genentech (the Option Agreement).
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7.4 Milestone Payments. Subject to the terms of the equity purchases set forth in the Stock Purchase Agreement and the credit as provided in the Option Agreement, Genentech made or shall make the following payments to IDEC, within 30 days after the first achievement of each of the following milestones for C2B8:
MILESTONE |
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(a) Upon Regulatory Approval in the United States |
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[CONFIDENTIAL TREATMENT REQUESTED] |
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(b) Upon Regulatory Approval in the First Major European Country |
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[CONFIDENTIAL TREATMENT REQUESTED] |
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(c) Patent Milestone Event |
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[CONFIDENTIAL TREATMENT REQUESTED] |
7.5 Share of Operating Profits or Losses. Upon the first Regulatory Approval in the United States, IDEC and Genentech shall share in Operating Profits or Losses from sales of Franchise Products in the Co-Promotion Territory as provided in Exhibit A.
7.6 Term of Operating Profits or Losses. The Parties shall share Operating Profits or Losses hereunder in the Co-Promotion Territory until the earlier of the date the Parties mutually agree to terminate the collaboration in the Co-Promotion Territory, or as provided in Section 15.2.
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7.8 Royalty Payment Reports. Royalty payments under this Agreement shall be made to IDEC or its designee quarterly within sixty (60) days following the end of each calendar quarter for which royalties are due. Each royalty payment shall be accompanied by a report summarizing the Royalty-Bearing Sales during the relevant three-month period.
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7.10 Taxes. IDEC shall pay any and all taxes levied on account of, or measured exclusively by, any payment including royalties it receives under this Agreement. If laws or regulations require that taxes be withheld, Genentech will (i) deduct those taxes from the remittable royalty, (ii) timely pay the taxes to the proper taxing authority, and (iii) send proof of payment to IDEC within sixty (60) days following that payment.
7.11 Blocked Currency. In each country where the local currency is blocked and cannot be removed from the country, at the election of Genentech, royalties accrued in that country shall be paid to IDEC in the country in local currency by deposit in a local bank designated by IDEC.
7.12 Foreign Exchange. For the purpose of computing Royalty-Bearing Sales for Franchise Products sold in a currency other than United States Dollars, such currency shall be converted into United States Dollars in accordance with Genentechs customary and usual translation procedures consistently applied.
7.13 Payments to or Reports by Affiliates. Any payment required under any provision of this Agreement to be made to either Party or any report required to be made by any Party shall be made to or by an Affiliate of that Party if designated by that Party as the appropriate recipient or reporting entity.
7.14 Sales By Sublicensees. In the event Genentech grants licenses or sublicenses to others to make or sell Franchise Products in the Licensed Territory, such licenses or sublicenses shall include an obligation for the licensee or sublicensee to account for and report its Royalty-Bearing Sales of such Franchise Products on the same basis as if such sales were Royalty-Bearing Sales by Genentech, and Genentech shall pay royalties to IDEC as if the Royalty-Bearing Sales of the licensee or sublicensee were Royalty-Bearing Sales of Genentech.
8.1 Process Development, Manufacturing Approvals of C2B8. IDEC shall be responsible for, at its own expense, process development, scale-up, validation and FDA licensure of its existing C2B8-producing CHO cell line to the 2,750 liter fermenter scale. As soon as practicable after the Original Effective Date, IDEC will transfer to Genentech a re-amplified CHO C2B8-producing cell line, and, within 30 days of the Original Effective Date, transfer the technology to be licensed to Genentech under the terms and conditions of the Expression Technology License of even date herewith, and provide reasonable training of Genentech personnel as requested by Genentech necessary to allow Genentech to scale up C2B8 process with the re-amplified cell line. Immediately after receipt of IDECs re-amplified CHO C2B8 producing cell line by Genentech, Genentech will begin work, at its own expense, on the scale-up of a re-amplified cell line in optimal growth media to produce C2B8 at commercial scale. If Genentech determines that such scale up is not commercially feasible, it will so notify the JDC. Upon the decision of the JDC to go forward, Genentech will, at its own expense, attempt to scale
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up another cell line selected by the JDC or the cell line used for 2,750 liter fermenter scale production. If Genentech has successfully scaled up a cell line to its commercial scale and IDEC is then manufacturing C2B8, Genentech will, at its own expense, transfer the optimized cell line and information sufficient to allow IDEC to manufacture C2B8 by essentially the same process used by Genentech except for the size of the fermentation vessel. If bridging or any other studies are required to permit the use or sale of C2B8 produced by Genentech by the optimized process, the costs of such clinical studies shall be paid by Genentech, but shall be charged against Operating Profits over the first three years after the first commercial sale of C2B8 produced by the optimized process. IDEC will otherwise be responsible, at its own expense, for all expenses incurred in obtaining Regulatory Approvals for the manufacturing process used to produce C2B8, except that Genentech, at its own expense, will pay the expenses incurred to receive FDA licensure of Genentech facilities. Notwithstanding anything to the contrary in this Section 8.1, costs incurred by either Party under this Section 8.1 after Regulatory Approval in the United States shall be charged to Operating Profits.
8.2 Manufacture and Supply of C2B8. IDEC shall, pursuant to a Supply Agreement to be entered into between the Parties prior to the date of the first submission of an application or registration for Regulatory Approval, supply all requirements for C2B8 in final vial form for commercial sale in all territories for the first two years after the first Regulatory Approval in the United States or Europe, whichever comes earlier (the Initial Commercial Period). The average annual Cost of Goods Sold of C2B8 packaged in final vial form during the Initial Commercial Period shall be the lower of (i) [CONFIDENTIAL TREATMENT REQUESTED] or (ii) [CONFIDENTIAL TREATMENT REQUESTED]. IDEC may continue to supply, at its option, commercial requirements for C2B8 up to the capacity of its current manufacturing plant [CONFIDENTIAL TREATMENT REQUESTED] in San Diego (the Supply Option). The Supply Option shall be exercised, if at all, by written notice on or before the date of the first Regulatory Approval including a good faith estimate of IDECs planned production levels. If the parties determine that the FDA will not grant establishment licenses to two manufacturing facilities using different scales of production, then the parties will use best efforts to develop a manufacturing capacity plan by the first Regulatory Approval. Subsequent to the Initial Commercial Period, if both Parties are manufacturing Licensed Product at the same time, the Cost of Goods Sold for both Parties used for calculation of Operating Profits shall be the lower of Genentechs or IDECs actual cost of Goods Sold for commercial production of C2B8 packaged in final vial form. After the Initial Commercial Period, Genentech shall manufacture all requirements of C2B8 for commercial sale in excess of that which IDEC has agreed to produce.
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8.4 Transfer Price of Products for C2B8. The transfer price for C2B8 supplied to Genentech for sale in the Licensed Territory will be [CONFIDENTIAL TREATMENT REQUESTED]. IDEC will invoice Genentech within 10 days after each shipment of C2B8 to the Licensed Territory on a shipment by shipment basis. Genentech shall pay each invoice within thirty (30) days of receipt of both of C2B8 and invoice.
8.6 Manufacture and Supply of Franchise Products (other than C2B8). Genentech shall be responsible, and have complete decision making control for all process development, scale-up, validation and FDA licensure for the manufacture of all Franchise Products (other than C2B8) in the Co-Promotion Territory, the cost of which shall be considered Development Costs pursuant to this Agreement. In addition, Genentech, either itself or through a third party manufacturer, shall be responsible for the manufacture and supply of clinical and commercial supply of New Products for the Co-Promotion Territory (Genentech shall use commercially reasonable and diligent efforts to maintain a reasonable Cost of Goods Sold for manufacture and supply of all Franchise Products).
8.7 Right of First Negotiation for Manufacture and Supply of Franchise Products in the Co-Promotion Territory. In the event Genentech decides to seek a Third Party (other than F. Hoffmann La Roche AG) to manufacture and supply a particular Franchise Product in the Co-Promotion Territory, Genentech shall promptly notify IDEC in writing. IDEC
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shall have thirty (30) days from the date of Genentechs notice to IDEC to provide written notice to Genentech that it elects to negotiate with Genentech the rights under which it may manufacture and supply such Franchise Product in the Co-Promotion Territory, and a failure to timely so elect shall be deemed a decision not to negotiate for such rights. In the event that IDEC timely notifies Genentech of its desire to engage in such negotiations, then for a period of ninety (90) days, Genentech and IDEC shall use good faith efforts to agree upon terms under which IDEC would manufacture and supply such Franchise Product in the Co-Promotion Territory. In the event that IDEC and Genentech have not entered into a definitive agreement within ninety (90) days of IDECs election to negotiate, then Genentech shall be free to grant to any Third Party the right to manufacture and supply such Franchise Product in the Co-Promotion Territory on any terms that Genentech considers appropriate.
25
CONFIDENTIAL TREATMENT
9.3 Sublicensing. Genentech may grant sublicenses to its rights under this Agreement with the prior written consent of IDEC, such consent not to be unreasonably withheld. IDEC hereby consents to such a sublicense to F. Hoffmann La Roche or any of its affiliates. Unless otherwise agreed, each sublicensee shall be subject to all of the obligations of Genentech hereunder applicable to that part of the territory being licensed.
9.4 Inclusion of Asia in the Licensed Territory. If a license in Asia becomes available on an exclusive basis with respect to C2B8, IDEC shall notify Genentech in writing. If such notification is prior to or on December 31, 1995, then Genentech shall pay IDEC [CONFIDENTIAL TREATMENT REQUESTED] upon signing of an amendment to this Agreement to include such territory in the Licensed Territory. After December 31, 1995, Genentech shall have the option to include Asia in the Licensed Territory, if available, on sixty (60) days written notice, for the [CONFIDENTIAL TREATMENT REQUESTED] license issue fee payable pursuant to this Section. IDEC agrees to use its best efforts within 90 days of the Original Effective Date to obtain at least a co-exclusive license for Genentech in the Asian territory. The consideration to IDEC for a co-exclusive license involving Genentech in the Asian territory shall not be less than [CONFIDENTIAL TREATMENT REQUESTED], of which Genentech shall pay no more than [CONFIDENTIAL TREATMENT REQUESTED]. If Asia is added to the Licensed Territory, it shall be subject to the same terms and conditions set forth in this Agreement, provided that Genentech shall have no obligation to make any additional payments with respect to such added Asian territory other than royalties as specified in this Agreement. Notwithstanding the foregoing provisions of this Section 9.4, the Parties acknowledge that Asia, pursuant to the First Amendment, is included within the Licensed Territory.
9.5 Shared Information. All of the information described in Section 14.1 below shall be deemed IDEC Know-how and Genentech Know-how for purposes of this Article 9 and the licenses granted herein.
9.6 Third Party Rights. In the event that IDEC or Genentech becomes aware of any Third Party rights that may be relevant to development, manufacture or commercialization of the Franchise Products in the Co-Promotion Territory, that Party shall promptly notify the other Party. To the extent that the Parties mutually agree that such rights are necessary to develop, manufacture or commercialize the Franchise Products in the Co-Promotion Territory, the Parties shall discuss an appropriate course of action to obtain a license to such rights in order to further the objectives of the Parties under this Agreement.
26
CONFIDENTIAL TREATMENT
10.1 (a) Product Trademarks for Licensed Products. All Licensed Products shall be sold in the Co-Promotion Territory under trademarks selected by the JCC and owned jointly by Genentech and IDEC in the Co-Promotion Territory and Licensed Territory. The JCC shall use best efforts to select a worldwide trademark. Each Party hereby grants the other a fully-paid co-exclusive license to use its trademarks in the Co-Promotion Territory for the Co-Promotion activities provided for in this Agreement. IDEC shall control preparation, prosecution and maintenance of applications related to such trademarks and the costs in the Co-Promotion Territory (Trademark Costs) shall (i) prior to Regulatory Approval in the United States, be paid by IDEC, and (ii) after Regulatory Approval in the United States, be included in Other Operating Income/Expense pursuant to Exhibit A. Genentech shall control preparation, prosecution, maintenance and applications related to trademarks in the Licensed Territory and shall pay all costs incurred with respect thereto, and will notify IDEC if Genentech believes in good faith that sole ownership of the trademark in a particular country in the Licensed Territory is the best method to protect the trademark, in which case Genentech shall be the sole owner of such trademark.
10.2 Infringement of Trademarks. Each Party shall notify the JCC promptly upon learning of any actual, alleged or threatened infringement of a trademark applicable to a Franchise Product (the Trademark) in the Co-Promotion Territory or of any unfair trade practices, trade dress imitation, passing off of counterfeit goods, or like offenses in the Co-Promotion Territory. Upon learning of such offenses from a Party regarding a jointly owned Trademark, the JMC shall confer with the Parties regarding which Party and counsel should be assigned to defend the Trademark. The Party defending the Trademark shall take all reasonable and appropriate steps to protect, defend and maintain the Trademark for use by the Parties in connection with the Franchise Product. Upon learning of such an offense from a Party regarding a Trademark owned solely by one of the Parties, and not provided for above in this Section, the JCC shall confer with the Parties regarding the defense of such Trademark. The decision whether and how to defend such a Trademark owned solely by one Party will rest with such Party.
10.3 Costs of Defense for Jointly Owned Trademark. All of the costs, expenses and legal fees in bringing, maintaining and prosecuting any action to maintain, protect or defend a
27
CONFIDENTIAL TREATMENT
jointly owned Trademark in the Co-Promotion Territory, and any recovery shall be included in the Other Operating Income/Expense. All of the costs, expenses and legal, fees in bringing, maintaining and prosecuting any action to maintain, protect or defend a Trademark in the Licensed Territory shall be paid by, and any recovery shall be paid to, Genentech.
11.1 Confidentiality; Exceptions. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing, the Parties agree that, for the term of this Agreement and for seven (7) years thereafter, the receiving Party shall keep confidential and shall not publish or otherwise disclose or use for any purpose other than as provided for in this Agreement any Information and other information and materials furnished to it by the other Party pursuant to this Agreement (collectively, Confidential Information), except to the extent that it can be established by the receiving Party that such Confidential Information:
11.2 Authorized Disclosure. Each Party may disclose Confidential Information hereunder to the extent such disclosure is reasonably necessary in filing or prosecuting patent applications, prosecuting or defending litigation, complying with applicable governmental regulations or conducting preclinical or clinical trials, provided that if a Party is required by law or regulation to make any such disclosure of the other Partys Confidential Information it will, except where impracticable for necessary disclosures, for example in the event of medical emergency, give reasonable advance notice to the other Party of such disclosure requirement and, except to the extent inappropriate in the case of patent applications, will use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed. In addition, each Party shall be entitled to disclose, under a binder of confidentiality containing provisions as protective as those of this Article 11, Confidential Information to consultants and other Third Parties only for any purpose provided for in this Agreement. Nothing in this Article 11 shall restrict any Party from using for any purpose any Information developed by it during the
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CONFIDENTIAL TREATMENT
course of the collaboration hereunder.
11.3 Survival. This Article 11 shall survive the termination or expiration of this Agreement for a period of seven (7) years.
11.4 Termination of Prior Agreement. This Agreement supersedes the Confidentiality Agreement between the Parties dated September 9, 1994. All Information exchanged between the Parties under that Agreement shall be deemed Confidential Information and shall be subject to the terms of this Article 11.
11.5 Publications. Prior to the end of Phase II Clinical Trials of each Franchise Product in the Co-Promotion Territory and subject to the applicable publication provisions of any Clinical Trial Agreements with investigators, the JDC with appropriate input from the JCC will determine the overall strategy for publication in support of such Franchise Product in the Co-Promotion Territory. Except as required by law, each Party agrees that it shall not publish or present the results of studies carried out as part of the collaboration without the approval of the JDC and the opportunity for prior review by the other Party. Each Party shall provide to the other the opportunity to review any proposed abstracts, manuscripts or presentations (including information to be presented verbally) which relate to any Franchise Product at least thirty (30) days prior to their intended submission for publication and such submitting Party agrees, upon written request from the other Party, not to submit such abstract or manuscript for publication or to make such presentation until the other Party is given a reasonable period of time to seek patent protection for any material in such publication or presentation which it believes is patentable.
12.1 Modified Definitions. For purposes of this Article 12, IDEC Patents, Genentech Patents and Genentech NP Patents shall not include Patents owned jointly by the Parties. Joint Patents shall mean Patents owned jointly by the Parties which cover the manufacture, use or sale of Franchise Products.
12.2 Ownership of Intellectual Property. IDEC shall own all inventions made under this Agreement solely by it or its employees. Genentech shall own all inventions made under this Agreement solely by its employees. All inventions made under this Agreement jointly by employees of IDEC and Genentech will be owned jointly by IDEC and Genentech and each Party shall retain full ownership under any Patents resulting therefrom, with full ownership rights in any field and subject to the licenses granted in Article 9, the right to sublicense without the consent of the other Party, without accounting. The laws of the United States with respect to joint ownership of inventions shall apply in all jurisdictions giving force and effect to this Agreement. The Parties shall jointly own Joint Know-how.
12.3 Disclosure of Patentable Inventions. In addition to the disclosures required under Article 14, each Party shall provide to the other, any written invention disclosure submitted to a Partys legal department in the normal course which discloses an invention made under this Agreement that is useful in the Field. Such invention disclosures shall be provided to
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CONFIDENTIAL TREATMENT
the other Party within thirty (30) days after the Party commences preparation of a patent application based on such disclosure.
12.4 Coordination. The Parties intend to prosecute and manage IDEC Patents, Genentech Patents and Genentech NP Patents for the purpose of providing the broadest protection for Franchise Products. The Parties will share information and each Party will consider the views of the other Party with respect to the scope of claims and decisions regarding the prosecution and maintenance of such Patents as necessary to achieve such purpose.
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31
CONFIDENTIAL TREATMENT
12.8 Further Assurances. Notwithstanding the provisions of Section 12.5 or Section 12.6 of this Agreement, each Party shall, at its own expense, provide reasonable assistance to the other Party to facilitate filing of all Patents covering inventions referred to in Section 12.2 of this Agreement and shall execute all documents deemed necessary or desirable therefor.
12.9 Initial Filings If Made Outside of the United States. The Parties agree to use reasonable efforts to ensure that any IDEC Patent, Genentech Patent, Genentech NP Patent or Joint Patent filed outside of the United States prior to a U.S. filing will be in a form sufficient to establish the date of original filing as a priority date for the purposes of a subsequent U.S. filing and that the requisite foreign filing license will be obtained.
32
CONFIDENTIAL TREATMENT
33
CONFIDENTIAL TREATMENT
13.1 Representations and Warranties. Each of the Parties hereby represents and warrants, as of the Restated Effective Date, as follows:
As used in this Section 13.1, Patents means IDEC Patent with respect to IDEC, and Genentech Patents and Genentech NP Patents with respect to Genentech; and Know-how means IDEC Know-how with respect to IDEC, and Genentech Know-how with respect to Genentech.
13.2 Performance by Affiliates. The Parties recognize that each may perform some or all of its obligations under this Agreement through Affiliates, provided, however, that each Party shall remain responsible and be guarantor of the performance by its Affiliates and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance.
14.1 Information. Genentech and IDEC will disclose and make available to each other all preclinical, clinical, regulatory, commercial and other information, including without limitation all information relevant to the joint promotion of Franchise Products, developed by Genentech or IDEC concerning Franchise Products at any time during the term of this Agreement. Each Party will use commercially reasonable and diligent efforts to disclose to the other Party all significant information promptly after it is learned or its significance is appreciated. Each Party shall own and maintain its own database of clinical trial data accumulated from all clinical trials of Franchise Products for which it was responsible and of adverse drug event information for all Franchise Products. At the option of the requesting Party, such data shall be provided in a computer readable format by the providing Party, to the extent available, which shall also assist in the transfer and validation of such data to the receiving Party.
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CONFIDENTIAL TREATMENT
14.2 Complaints. Each Party shall maintain a record of all complaints it receives with respect to any Franchise Product. Each Party shall notify the other of any complaint received by it in sufficient detail and within five (5) business days after the event, and in any event in sufficient time to allow the responsible Party to comply with any and all regulatory requirements imposed upon it in any country.
14.3 Adverse Drug Events. The Parties recognize that the holder of a Drug Approval Application may be required to submit information and file reports to various governmental agencies on compounds under clinical investigation, compounds proposed for marketing, or marketed drugs. Information must be submitted at the time of initial filing for investigational use in humans and at the time of a request for market approval of a new drug. In addition, supplemental information must be provided on compounds at periodic intervals and adverse drug experiences must be reported at more frequent intervals depending on the severity of the experience. Consequently, each Party agrees to:
14.4 Records of Net Sales and Costs. Each Party will maintain complete and accurate records which are relevant to costs, expenses, sales and payments under this Agreement and such records shall be open during reasonable business hours for a period of three (3) years from creation of individual records for examination at the other Partys expense, and, with respect to the audit provisions of Section A.6.1 and A.6.2 of Exhibit A, such examination shall not be conducted more often than once each year by an independent public accountant selected by the other Party as described in A.6 of Exhibit A. Any records or accounting information received from the other Party shall be Confidential Information for purposes of Article 11. Results of any such audit shall be provided to both Parties, subject to Article 11.
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CONFIDENTIAL TREATMENT
14.5 Publicity Review. The Parties agree that the public announcement of the execution of this Agreement shall be in the form of a press release to be agreed upon on or before the Restated Effective Date and thereafter each Party shall be entitled to make or publish any public statement consistent with the contents thereof. Thereafter, IDEC and Genentech will jointly discuss and agree, based on the principles of this Section 14.5, on any statement to the public regarding this Agreement or any aspect of this Agreement subject in each case to disclosure otherwise required by law or regulation as determined in good faith by each Party. The principles to be observed by IDEC and Genentech in such public disclosures will be: accuracy, the requirements for confidentiality under Article 11, the advantage a competitor of IDEC or Genentech may gain from any public statements under this Section 14.5, and the standards and customs in the biotechnology and pharmaceutical industries for such disclosures by companies comparable to IDEC and Genentech. The terms of this Agreement may also be disclosed to (i) government agencies where required by law, or (ii) Third Parties with the prior written consent of the other Party, which consent shall not be unreasonably withheld, so long as such disclosure is made under a binder of confidentiality and so long as highly sensitive terms and conditions such as financial terms are extracted from the Agreement or not disclosed upon the request of the other Party.
15.1 Term. This Agreement, which shall commence as of the Restated Effective Date, shall continue the collaboration contemplated by the Parties under the Original Agreement, including the First Amendment and Second Amendment thereto, as modified hereby. The Parties have specifically provided elsewhere in this Agreement the term during which certain rights and obligations hereunder shall apply. Unless sooner terminated as provided herein and except as provided in Section 15.2 below, (a) the remaining provisions of this Agreement relating to activities in the Co-Promotion Territory shall continue in effect until the date on which the Parties are no longer entitled to receive a share of Operating Profits or Losses on any Franchise Product and (b) the remaining provisions of this Agreement relating to activities in the Licensed Territory shall continue in effect until the date on which Genentech is no longer required to pay a royalty on Royalty-Bearing Sales in the Licensed Territory. Those provisions shall govern the term of the rights and obligations specifically covered thereby. Upon the expiration, but not an earlier termination, of this Agreement, all licenses granted by either Party to the other Party hereunder shall become fully paid up and irrevocable.
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Stage of Product |
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Royalty Price |
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After completion of the [CONFIDENTIAL TREATMENT REQUESTED] for the product, but prior to [CONFIDENTIAL TREATMENT REQUESTED] of such product: |
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Compensation equivalent to [CONFIDENTIAL TREATMENT REQUESTED] of such product in the United States. |
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After [CONFIDENTIAL TREATMENT REQUESTED] of the product: |
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With respect to such New Products, compensation to IDEC or payment by IDEC to Genentech equivalent to [CONFIDENTIAL TREATMENT REQUESTED] for such New Product in the United States, and With respect to such Third Party Anti-CD20 Products, compensation to IDEC or payment by IDEC to Genentech equivalent to the amount otherwise specified to be paid on such product in the United States [CONFIDENTIAL TREATMENT REQUESTED], as established pursuant to the provisions of Section 2.6. |
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CONFIDENTIAL TREATMENT
It is understood and agreed that Genentech shall only be required to make Royalty Price payments on such New Products or Third Party Anti-CD20 Products (which were opted in by IDEC pursuant to Section 2.6 prior to the Auction Notice) which were under development pursuant to an approved or proposed Development Plan or being commercially sold at the time of such Auction Notice, and that subsequent development of any products incorporating any protein or peptide, other than the proteins or peptides that were incorporated into such New Products or Third Party Anti-CD20 Products, shall not be subject to such Royalty Price payments.
38
CONFIDENTIAL TREATMENT
39
CONFIDENTIAL TREATMENT
As used in this Section 15.2(c), Patents means IDEC Patent with respect to IDEC, and Genentech Patents and Genentech NP Patents with respect to Genentech; and Know-how means IDEC Know-how with respect to IDEC, and Genentech Know-how with respect to Genentech.
40
CONFIDENTIAL TREATMENT
15.3 Accrued Rights, Surviving Obligations. Termination, relinquishment or expiration of the Agreement for any reason shall be without prejudice to any rights which shall have accrued to the benefit of either Party prior to such termination (including paid up irrevocable licenses), relinquishment or expiration, including damages arising from any breach hereunder. Such termination, relinquishment or expiration shall not relieve either Party from obligations under Articles 11, 12, 16 and 18 herein, and any other obligations which are expressly indicated to survive termination or expiration of the Agreement.
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CONFIDENTIAL TREATMENT
17.1 Disputes. The Parties recognize that disputes as to certain matters may from time to time arise during the term of this Agreement which relate to either Partys rights and/or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this Article 17, if and when a dispute arises under this Agreement. Unless otherwise specifically recited in this Agreement, disputes among members of each Operating Committee will be resolved as recited in this Article 17. Any disputes among members of Operating Committees formed hereunder relating to the collaboration, and which are within the scope of such Operating Committees responsibilities, shall be first referred to the Management Committee by either Party at any time after such dispute has arisen and such Party believes that there has been sufficient discussion of the matter at the Operating Committee level. If the Management Committee is unable to resolve such a dispute within thirty (30) days of being requested by a Party to resolve an Operating Committee dispute, any Party may, by written notice to the other, have such dispute referred to their respective chief executive officers, for attempted resolution by good faith negotiations within fourteen (14) days after such notice is received. In the event the designated executive officers are not able to resolve such dispute, such dispute shall be resolved as follows:
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CONFIDENTIAL TREATMENT
17.2 Arbitration. The parties agree that any dispute, controversy or claim (except as to any issue relating to intellectual property owned in whole or in part by IDEC or Genentech) arising out of or relating to this Agreement, or the breach, termination, or invalidity thereof, shall be resolved through negotiation and/or binding arbitration. If a dispute arises between the parties, and if said dispute cannot be resolved pursuant to Section 17.1, the Parties agree that any unresolved controversy or claim between the parties shall be resolved by binding arbitration in accordance with the Commercial Arbitration Rules of the American Arbitration Association, except as modified herein. The Company and Buyer shall each select one arbitrator and the two arbitrators so selected shall choose a third arbitrator to resolve the dispute. The arbitration decision shall be rendered in a writing stating the basis on which the decision was made within six months of conclusion of arbitration and shall be binding and not be appealable to any court in any jurisdiction. The prevailing Party may enter such decision in any court having competent jurisdiction. The arbitration proceeding shall be conducted at the location of the Party not originally requesting the resolution of the dispute. The Parties agree that they shall share equally the cost of the arbitration filing and hearing fees, and the cost of the arbitrator. Each Party must bear its own attorneys fees and associated costs and expenses.
17.3 Jurisdiction. For the purposes of this Article 17, the Parties agree to accept the jurisdiction of the federal courts located in the Northern District of California for the purposes of enforcing awards entered pursuant to this Article and for enforcing the agreements reflected in this Article.
17.4 Determination of Patents and Other Intellectual Property. Any dispute relating to the determination of validity of a Partys Patents or other issues relating solely to a Partys intellectual property shall be submitted exclusively to the federal court located in the location of the defendant, and the Parties hereby consent to the jurisdiction and venue of such court.
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CONFIDENTIAL TREATMENT
18.2 Non-Solicitation. The Parties recognize that each Party has a substantial interest in preserving and maintaining confidential its Confidential Information hereunder. Each Party recognizes that certain of the other Partys employees, including those engaged in development, marketing and sale of any Franchise Product, may have access to such Confidential Information of the other Party. The Parties therefore agree not to solicit or otherwise induce or attempt to induce for purposes of employment, any employees from the other Party involved in the development, marketing or sales of any Franchise Product during the period in which any Party is developing or commercializing a Franchise Product in the Co-Promotion Territory hereunder and for a period of two years thereafter.
18.3 Consents Not Unreasonably Withheld. Whenever provision is made in this Agreement for either Party to secure the consent or approval of the other, that consent or approval shall not unreasonably be withheld, and whenever in this Agreement provision is made for one Party to object to or disapprove a matter, such objection or disapproval shall not unreasonably be exercised.
18.4 Retained Rights. Nothing in this Agreement shall limit in any respect the right of either Party to conduct research and development with respect to and market products outside the Field using such Partys technology.
18.5 Force Majeure. Neither Party shall lose any rights hereunder or be liable to the other Party for damages or losses on account of failure of performance by the defaulting Party if the failure is occasioned by government action, war, earthquake, fire, explosion, flood, strike, lockout, embargo, mycoplasmal contamination, act of God, or any other cause beyond the control of the defaulting Party, provided that the Party claiming force majeure has exerted all reasonable efforts to avoid or remedy such force majeure; provided however, that in no event shall a Party be required to settle any labor dispute or disturbance.
18.6 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
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CONFIDENTIAL TREATMENT
18.7 No Right to Use Names. Except as otherwise provided herein, no right, express or implied, is granted by the Agreement to use in any manner the name IDEC, Genentech or any other trade name or trademark of the other Party or its Affiliates in connection with the performance of the Agreement.
18.8 Notices. All notices hereunder shall be in writing and shall be deemed given if delivered personally or by facsimile transmission (receipt verified), telexed, mailed by registered or certified mail (return receipt requested), postage prepaid, or sent by express courier service, to the Parties at the following addresses (or at such other address for a Party as shall be specified by like notice; provided, that notices of a change of address shall be effective only upon receipt thereof).
If to IDEC, addressed to: |
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IDEC PHARMACEUTICALS CORPORATION |
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If to Genentech, addressed to: |
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GENENTECH. INC. |
18.9 Waiver. Except as specifically provided for herein, the waiver from time to time by either of the Parties of any of their rights or their failure to exercise any remedy shall not operate or be construed as a continuing waiver of same or of any other of such Partys rights or remedies provided in this Agreement.
18.10 Severability. If any term, covenant or condition of this Agreement or the application thereof to any Party or circumstance shall, to any extent, be held to be invalid or unenforceable, then (i) the remainder of this Agreement, or the application of such term, covenant or condition to Parties or circumstances other than those as to which it is held invalid or unenforceable, shall not be affected thereby and each term, covenant or condition of this Agreement shall be valid and be enforced to the fullest extent permitted by law; and (ii) the Parties hereto covenant and agree to renegotiate any such term, covenant or application thereof in good faith in order to provide a reasonably acceptable alternative to the term, covenant or condition of this Agreement or the application thereof that is invalid or unenforceable, it being the intent of the Parties that the basic purposes of this Agreement are to be effectuated.
18.11 Governing Law. This Agreement shall be governed by and construed in accordance with, the laws of the State of California without giving effect to principles of conflict of laws.
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18.12 Ambiguities. Ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authorized the ambiguous provision.
18.13 Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
18.14 Entire Agreement. This Agreement, including all Exhibits and the Appendix attached hereto which are hereby incorporated herein by reference, sets forth all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto and supersedes and terminates the Original Agreement between the Parties; provided, Exhibits B and D to the Original Agreement and the First Amendment and the Second Amendment shall as of the Restated Effective Date be incorporated herein by reference and deemed Exhibits B and D, the First Amendment and the Second Amendment, respectively to this Agreement; provided further, with respect to any conflict between this Agreement and the Original Agreement (including Exhibits B and D, the First Amendment and the Second Amendment thereto), as to any acts or omissions by the parties that occurred after the Original Effective Date but prior to the Restated Effective Date, the terms of the Original Agreement shall prevail. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as set forth herein and therein; provided, to the extent the Parties entered into any written agreements (other than the Original Agreement, the First Amendment or the Second Amendment) with respect to Third Party intellectual property rights regarding the development, manufacture or commercialization of Licensed Products prior to the Restated Effective Date, and to the extent such agreements are in full force and effect immediately prior to the Restated Effective Date, such agreements (including without limitation, that certain Letter Agreement between the Parties of May 21, 1996 relating to the Original Agreement) shall continue in full force and effect under their respective terms and not be deemed to be superseded by this Agreement. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties hereto unless reduced to writing and signed by the respective authorized officers of the Parties.
IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate originals by their proper officers as of the date and year first above written.
IDEC PHARMACEUTICALS CORPORATION |
GENENTECH, INC. |
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By: |
/s/ William H. Rastetter |
By: |
/s/ Arthur D. Levinson |
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William H. Rastetter |
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Arthur D. Levinson |
Title: |
Chairman and CEO |
Title: |
Chairman and CEO |
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CONFIDENTIAL TREATMENT
APPENDIX 1
TO THE
AMENDED AND RESTATED COLLABORATION BETWEEN IDEC
PHARMACEUTICALS CORPORATION AND GENENTECH, INC.
SCHEDULE OF MASTER DEFINITIONS
1
CONFIDENTIAL TREATMENT
2
CONFIDENTIAL TREATMENT
3
CONFIDENTIAL TREATMENT
4
CONFIDENTIAL TREATMENT
5
CONFIDENTIAL TREATMENT
6
CONFIDENTIAL TREATMENT
As used in this Collaboration Agreement, protein or peptide means any protein or peptide having a [CONFIDENTIAL TREATMENT REQUESTED]; [CONFIDENTIAL TREATMENT REQUESTED]. Notwithstanding the foregoing, [CONFIDENTIAL TREATMENT REQUESTED], and Potential New Products and New Products shall not be considered Third Party Anti-CD20 Products.
7
CONFIDENTIAL TREATMENT
8
CONFIDENTIAL TREATMENT
9
CONFIDENTIAL TREATMENT
EXHIBIT A
FINANCIAL PLANNING,
ACCOUNTING AND REPORTING
FOR THE
AMENDED AND RESTATED IDEC/GENENTECH COLLABORATION AGREEMENT
This Exhibit A to the Amended and Restated Collaboration Agreement (the Collaboration Agreement) dated as of June 19, 2003, between IDEC Pharmaceuticals Corporation (IDEC) and Genentech, Inc. (Genentech) addresses the financial planning, accounting policies and procedures to be followed in determining Operating Profits or Losses and related sharing of revenue and expenses in the Co-Promotion Territory. Terms not defined in this Exhibit shall have the meanings set forth in the Schedule of Master Definitions which is attached as Appendix 1 to the Collaboration Agreement, or to the extent not in the Schedule of Master Definitions, in the Collaboration Agreement.
This Exhibit sets forth the principles for reporting actual results and budgeted plans of the combined operations in the Co-Promotion Territory, the frequency of reporting, the use of a single functional currency for reporting, and the methods of determining payments to the Parties and auditing of accounts.
For purposes of this Exhibit only, the consolidated accounting of operations for the collaboration in the Co-Promotion Territory shall be referred to as GenIDEC. GenIDEC is not a legal entity and has been defined for identification purposes only.
The results of operations of GenIDEC will be presented in the following format (as to all Franchise Products and also on a product-by-product basis), with the categories as defined in Section A.4 below:
A.1(a)Income Statement |
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less Sales Returns and Allowances |
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= Net Sales |
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less Cost of Sales |
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= Gross Profits |
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less Marketing Costs |
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less Sales Costs |
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less Development Costs chargeable to GenIDEC |
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less Other Operating Income/Expense |
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= Contribution |
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less Distribution Costs |
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less Administration Costs |
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= Operating Profit (Loss) |
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It is the intention of the Parties that the interpretation of these definitions will be consistent with generally accepted accounting principles in the United States.
1
CONFIDENTIAL TREATMENT
A.1(b) Subcomponent Reporting
For reporting purposes only, expenses will be identified for the budget, forecast, and quarterly actuals reporting events within this Section A.1 by the following detail sub-components within the aggregate Income Statement expense components specified under Section A.1(a):
Cost of Sales cost of goods sold (COGS), cost of sales royalties, freight & other
Marketing marketing promotion, market research, marketing headcount
Sales sales headcount, sales promotion & sales operations
Development by indication label-enabling activities & trials, by indication post-marketing activities & trials
The requirement defined within Section 4.5, 5.4 (b) and 17.1(a) not to exceed budget by [CONFIDENTIAL TREATMENT REQUESTED] without unanimous JDC or JCC approval, as applicable, shall not apply to these reporting detail sub-components, but shall only apply to the aggregate expense components specified within the Income Statement format specified within Section A.1(a).
A.2. Frequency of Reporting
The fiscal year of GenIDEC will be a calendar year.
Reporting by each Party for GenIDEC revenues and expenses will be performed as follows (with copies provided to the JFC and to the other Party):
Reporting Event |
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Frequency |
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Timing of Submission |
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Actuals |
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Quarterly |
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Q1-Q3: |
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+30 days |
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Q4: |
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+45 days |
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Forecasts |
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Quarterly |
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Mid Quarter |
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(rest of year - by month) |
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Budgets |
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Annually |
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October 31st |
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(one year - by month) |
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Long Range Plan |
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Annually |
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July 31st |
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(current year plus 5 years) |
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2
CONFIDENTIAL TREATMENT
Genentech will be responsible for the preparation of consolidated reporting (actuals, budgets, forecasts, and long range plans), calculation of the profit/loss sharing and determination of the cash settlement. Genentech will provide the JFC (and IDEC) within five working days of the submission date shown above, a statement showing the consolidated results (and forecasts) and calculations of the profit/loss sharing and cash settlement required in a format agreed to by the Parties.
Reports of actual results compared to budget (as to all Franchise Products and also on a product-by-product basis) will be made to the Operating Committees on a quarterly basis. After approval by the JFC as to amounts, the JFC will forward the report to the Management Committee for its approval. Line item variances from budgets judged to be significant by the JFC will only be included in calculation of Operating Profit and Loss when approved by the JCC and the Management Committee.
On a monthly basis Genentech will supply IDEC with Gross Sales (as to all Franchise Products and also on a product-by-product basis) in units, local currency and U.S. dollars by country of each months sales according to Genentechs sales reporting system, which shall be consistent with the definitions in Section A.4.
The Joint Finance Committee will meet as appropriate to review and approve the following (as to all Franchise Products and also on a product-by-product basis):
Actual Results
Forecasts
Budget
Inventory Levels
Sales Returns and Allowances
Other financial matters, including each Partys methodologies for charging costs and allocating Sales Representatives to GenIDEC for actuals, forecasts, budgets and long range plans and the results of applying such methodologies.
Responsibility for the Budget and Long Range Plan with regard to Licensed Products, [CONFIDENTIAL TREATMENT REQUESTED], will rest with the JCC and the JDC, who will develop budgets for development and commercialization in coordination with the Joint Finance Committee, subject to final approval by the Management Committee.
Responsibility for the Budget and Long Range Plan with regard to New Products, including, without limitation, G2H7, and with regard to all Franchise Products (including, without limitation, C2B8) [CONFIDENTIAL TREATMENT REQUESTED], will rest with
3
CONFIDENTIAL TREATMENT
Genentech, who will develop budgets for development and commercialization in coordination with the Joint Finance Committee, subject to final approval by the Management Committee.
Budgets will be prepared annually for the following full calendar year containing monthly details/numbers.
Budgets will be supplemented with high level business plans and costs for clinical trials, registration applications, and plans for product introduction, sales efforts and promotion as approved by the Joint Development Committee and Joint Commercialization Committee. Budgets, once ratified by the Management Committee, can only be changed with the approval of the Management Committee (with the exception of the provisions outlined in Sections 4.5 and 5.4(b) of the Collaboration Agreement).
A five-year Long Range Plan for GenIDEC will be established on a yearly basis under the direction of the Management Committee and submitted to Genentech and IDEC by July 31st.
A.4.1 Administration Costs means, as to each Franchise Product in the Co-Promotion Territory, costs chargeable to GenIDEC equal to [CONFIDENTIAL TREATMENT REQUESTED] of the sum of each Partys own Marketing Costs and Sales Costs and Development Costs (each, only to the extent chargeable to GenIDEC), subject to a cap for each Party, as to all Franchise Products, in each calendar year of [CONFIDENTIAL TREATMENT REQUESTED] (subject to annual increases per the PPI).
A.4.2 Allocable Overhead means costs incurred by a Party or for its account which are attributable to a Partys supervisory, services, occupancy costs, corporate bonus (to the extent not charged directly to department), and its payroll, information systems, human relations or purchasing functions and which are allocated to company departments based on space occupied or headcount or other activity-based method. Allocable Overhead shall not include any costs attributable to general corporate activities including, by way of example, executive management, investor relations, business development, legal affairs and finance.
A.4.3 Cost of Goods Sold means, as to each Franchise Product in the Co-Promotion Territory, the fully burdened cost of such Franchise Product in final therapeutic form as limited by Section 8.2 or Section 8.6. The fully burdened cost of each Franchise Product will be determined in accordance with generally accepted accounting principles in the United States as applied by the Party performing or contracting for each stage of the manufacturing process and will include direct labor, material, product testing costs and Allocable Overhead.
A.4.4 Cost of Sales means, as to each Franchise Product in the Co-Promotion Territory, Cost of Goods Sold, Third Party Royalties (except to ML/MS Partners) (i.e., any allocable intellectual property acquisition and licensing costs) and outbound freight on sales if borne by the seller.
4
CONFIDENTIAL TREATMENT
A.4.5 Development Costs means, as to each Franchise Product in the Co-Promotion Territory, costs, including Allocable Overhead, required to obtain the authorization and/or ability to manufacture, formulate, fill, ship and/or sell such Franchise Product in the Field in commercial quantities in the Co-Promotion Territory. Development Costs shall include but are not limited to the cost of studies on the toxicological, pharmacokinetic, metabolic or clinical aspects of such Franchise Product conducted internally or by individual investigators, or consultants necessary for the purpose of obtaining and/or maintaining approval of such Franchise Product in the Field by a government organization in a country of the Co-Promotion Territory, and costs for preparing, submitting, reviewing or developing data or information for the purpose of a submission to a governmental authority to obtain and/or maintain approval of such Franchise Product in the Field in a country of the Co-Promotion Territory as well as costs of process development scale-up and recovery (including plant costs). In addition, Development Costs in the Co-Promotion Territory shall include the cost of post-launch clinical studies in support of such Franchise Product in the Field in the Co-Promotion Territory. Development Costs in the Co-Promotion Territory shall include expenses for compensation, benefits and travel and other employee-related expenses, as well as data management, statistical designs and studies, document preparation, and other expenses associated with the clinical testing program. Development Costs that are to be paid solely by one but not both of the Parties as set forth in Section 2.3 of the Collaboration Agreement shall not be included in the determination of Operating Profits (Losses).
A.4.6 Distribution Costs means, as to each Franchise Product in the Co-Promotion Territory, the costs, including Allocable Overhead, specifically identifiable to the distribution of such Franchise Product including customer services, collection of data of sales to hospitals and other end users (e.g. DDD sales data), order entry, billing, credit and collection and other activities described in Section 5.3 of the Agreement. For the purpose of this Agreement, only Genentech will charge GenIDEC for Distribution Costs an amount of [CONFIDENTIAL TREATMENT REQUESTED] of Net Sales in a lump sum.
A.4.7 Gross Sales means, as to each Franchise Product in the Co-Promotion Territory, the gross amount invoiced by either Party or their Affiliates or permitted sublicensees for sales of such Franchise Product to Third Parties in the Co-Promotion Territory.
A.4.8 Marketing Costs means, as to each Franchise Product in the Co-Promotion Territory, the costs, excluding Allocable Overhead, of marketing, promotion, advertising, professional education, product related public relations, relationships with opinion leaders and professional societies, market research, healthcare economics studies and other similar activities directly related to such Franchise Product and approved by the Joint Commercialization Committee. Such costs will include both internal costs (e.g., salaries, benefits, supplies and materials, etc.) as well as outside services and expenses (e.g., consultants, agency fees, meeting costs, etc.). Marketing Costs shall also include activities related to obtaining reimbursement from payers and costs of sales and marketing data. Marketing Costs will specifically exclude the costs of activities which promote (i) either Partys business as a whole without being product specific (such as corporate image advertising), or (ii) non-Franchise Products.
5
CONFIDENTIAL TREATMENT
A.4.10 Operating Profit or Loss means, as to all Franchise Products (or, where applicable, on a product-by-product basis), GenIDECs Net Sales less the following items: Cost of Sales, Marketing Costs, Sales Costs, Development Costs, (to the extent chargeable to GenIDEC), Other Operating Income/Expense, Distribution Costs and Administrative Costs, for a given period.
A.4.11 Other Operating Income/Expense means other operating income or expense from or to third parties which is not part of the primary business activity of GenIDEC, but is considered and approved by the Joint Finance Committee as income or expense generated from GenIDEC operations, and limited to the following:
Inventory Write-Offs
Patent Costs (as defined and to the extent permitted in the Collaboration Agreement)
Product liability insurance to the extent the Parties obtain a joint policy
Other (To be approved by JFC)
A.4.12 Sales Costs means, as to each Franchise Product in the Co-Promotion Territory (to the extent practicable and without being overly burdensome to provide, Sales Costs will be identifed on a product-by-product basis, otherwise such Sales Costs shall be attributed between the products in a reasonable manner as determined by the JFC), costs, including Allocable Overhead, approved by the JCC and the annual budget and specifically identifiable to the sales of such Franchise Product to all markets in the Co-Promotion Territory including the managed care market. Sales Costs shall include costs associated with Sales Representatives, including compensation, benefits and travel, supervision and training of the Sales Representatives, sales meetings, and other sales expenses. Sales Costs will not include the start-up costs associated with either Partys sales force, including recruiting, relocation and other similar costs.
A.4.13 Sales Returns and Allowances means, as to each Franchise Product in the Co-Promotion Territory, the sum of (a), (b) and (c) where (a) is a provision, determined under generally accepted accounting principles in the United States, for (i) trade, cash and quantity discounts or rebates (other than price discounts granted at the time of invoicing and which are included in the determination of Gross Sales), (ii) credits or allowances given or made for rejection or return of, and for uncollectible amounts on, previously sold products or for retroactive price reductions (including Medicare and similar types of rebates), (iii) taxes, duties or other governmental charges levied on or measured by the billing amount, as adjusted for rebates and refunds, (iv) charges for freight and insurance directly related to the distribution of such Franchise Product, and (v) credits or allowances given or made for wastage replacement, indigent patient and any other sales programs agreed to by the Parties, (b) is a periodic adjustment of the provision determined in (a) to reflect amounts actually incurred for (i), (ii), (iii), (iv) and (v), and (c) is the Combination Product Adjustment as defined in the Agreement, if
6
CONFIDENTIAL TREATMENT
any. Provisions allowed in (a) and adjustments made in (b) and (c) will be reviewed by the Joint Finance Committee.
The functional currency for accounting for operating profit will be U.S. Dollars.
The statement of operations will be translated into U.S. dollars using the average exchange rate for the reporting period.
7
CONFIDENTIAL TREATMENT
Parties, to support the requesting Partys relevant internal control understanding and compliance assertions. All costs incurred by the other Party in complying with such request shall be reimbursed by the requesting Party.
Balancing payments between the Parties will be approved by the Management Committee based on Operating Profit or Loss. Payments will be made quarterly based on actual results within 60 days after the end of each quarter, adjusted for reimbursement of the net expenses or income incurred or received by each Party.
All Development Costs, Marketing Costs and Sales Costs will be based on the appropriate costs definition stated in Section A.4 of this Exhibit.
Each party shall report Development Costs in a manner consistent with its Project Cost System. In general, these project cost systems report actual time spent on specific projects, apply the actual labor costs, capture actual costs of specific projects and allocate other expenses to projects. For Marketing Costs, the Parties will report costs based on spending in Marketing departments. The Parties acknowledge that the methodologies used will be based on systems in place and consistent with Section A.11 of this Exhibit.
For the purpose of determining Sales Costs, the Parties, through the JCC and JFC shall determine the number of Sales Representatives selling Franchise Products during the period and develop a method consistent with Sections A.4 and A.11 of this Exhibit to allocate Sales Costs to those Sales Representatives.
The Parties agree to share the Operating Profit or Loss resulting from the collaborative arrangement in the Co-Promotion Territory according to the following manner:
8
CONFIDENTIAL TREATMENT
other pre-launch marketing or commercial activities approved by the Joint Commercialization Committee and the Joint Finance Committee, and (ii) IDEC shall repay its [CONFIDENTIAL TREATMENT REQUESTED] share of such costs following product approvals from the Operating Profits allocated to IDEC in any calendar quarter. If repayment is not complete three years following first approval, IDEC shall complete repayment in a lump sum at the end of the next calendar quarter. Interest on any such repayment will be charged at a rate equal to the sum of [CONFIDENTIAL TREATMENT REQUESTED].
(i) [CONFIDENTIAL TREATMENT REQUESTED], respectively, of the first [CONFIDENTIAL TREATMENT REQUESTED] in Operating Profits (calculated with respect to all Franchise Products); except that for the calendar year in which the First New Product FDA Approval occurs, this first [CONFIDENTIAL TREATMENT REQUESTED] Operating Profits tier shall only apply with respect to Operating Profits of all Franchise Products if this first [CONFIDENTIAL TREATMENT REQUESTED] Operating Profits tier has not been completely achieved, and then only to the extent it has not been achieved, with respect to Operating Profits of Licensed Products (as defined within A.9.1) prior to the First New Product FDA Approval; and
(ii) [CONFIDENTIAL TREATMENT REQUESTED], respectively, of the Operating Profits (calculated with respect to all Franchise Products) in excess of the first [CONFIDENTIAL TREATMENT REQUESTED] in Operating Profits (calculated with respect to all Franchise Products) until the First Threshold Date (as used herein the First Threshold Date means the later of [CONFIDENTIAL TREATMENT REQUESTED]; and
(iii) [CONFIDENTIAL TREATMENT REQUESTED], respectively, of the Operating Profits (calculated with respect to all Franchise Products) in excess of the first [CONFIDENTIAL TREATMENT REQUESTED] in Operating Profits (calculated with respect to all Franchise Products) following the First Threshold Date and until the Second Threshold Date (as used herein the Second Threshold Date means the later of [CONFIDENTIAL TREATMENT REQUESTED]; and
(iv) [CONFIDENTIAL TREATMENT REQUESTED], respectively, of the Operating Profits (calculated with respect to all Franchise Products) following the Second Threshold Date; and
9
CONFIDENTIAL TREATMENT
(v) [CONFIDENTIAL TREATMENT REQUESTED], respectively, of any Operating Losses, calculated with respect to all Franchise Products.
Within a calendar month that the First Threshold Date or the Second Threshold Date is met, Operating Profits shall be calculated by (x) pro-rating the expenses in such month on a straight line basis to pre and post threshold time frames, (y) identifying daily product sales within such calendar month by the pre and post threshold timeframes and (z) allocating their related Cost-of-Sales by the proper product sales proportions for pre and post threshold timeframes.
Operation of GenIDEC will be deemed to have commenced on April 1, 1995. Costs incurred prior to April 1, 1995, are not chargeable to GenIDEC. Costs incurred with respect to a Potential New Product prior to the time such product becomes a New Product under the Collaboration Agreement are not chargeable to GenIDEC.
The following guidelines shall be used in determining amounts chargeable to GenIDEC subject to the cost definitions in Section A.4 of this Exhibit. Disputes over the allocation of costs are not subject to Genentechs tie breaking vote under Section 17.1.
(a) If the portion of that expense used for the development or commercialization of such Franchise Product in the Field in the Licensed Territory can be objectively determined through specific means (e.g., man hours of effort, amounts consumed, etc.), then the amount so used will be charged to Genentech and the remaining portion will be charged to GenIDEC.
(b) If the Franchise Product is a Licensed Product and if the portion of that expense used for the development or commercialization of such Franchise Product in the Field in the Licensed Territory cannot be objectively determined through specific means, then only the direct and incremental costs related to such Franchise Product in the Field in the Licensed
10
CONFIDENTIAL TREATMENT
Territory will be charged to Genentech and the remaining portion will be charged to GenIDEC.
(c) If the Franchise Product is a New Product and if the portion of that expense used for the development or commercialization of such Franchise Product in the Field in the Licensed Territory cannot be objectively determined through specific means, then only the direct and incremental costs related to such Franchise Product in the Field in the Co-Promotion Territory will be charged to GenIDEC and the remaining portion will be charged to Genentech.
(a) If the portion of that expense used for the development or commercialization of a Franchise Product in the Field in the Co-Promotion Territory can be objectively determined through specific means (e.g., man hours of effort, amounts consumed, etc.), then the amount so used will be charged to GenIDEC.
(b) If the portion of that expense used for the development or commercialization of a Franchise Product in the Field in the Co-Promotion Territory cannot be objectively determined through specific means, then only the direct and incremental costs related to the Franchise Product in the Field shall be charged to GenIDEC.
11
CONFIDENTIAL TREATMENT
Exhibit B
C2B8
C2B8 shall have the meaning as defined in Exhibit B to the Original Agreement.
CONFIDENTIAL TREATMENT
Exhibit D
IDEC Third Party License Agreements
IDEC- Third Party License Agreements shall have the meaning as defined in Exhibit D to the Original Agreement.
CONFIDENTIAL TREATMENT
Exhibit G
Excluded Patents
Cabilly Patents
Cabilly Patents shall mean the Licensed Patents as defined in Section 1.09 of the Cabilly License (as defined in the Collaboration Agreement).
Itakura/Riggs Patents
Itakura/Riggs Patents shall mean any of the U.S. patents listed below and any and all divisionals, continuations, continuations-in-part, reissues, reexaminations or extensions of these patents or of any application from which these U.S patents claim priority, as well as foreign counterparts of the foregoing.
U.S. 4,356,270
U.S. 4,366,246
U.S. 4,425,437
U.S. 4,431,739
U.S. 4,563,424
U.S. 4,571,421
U.S. 4,704,362
U.S. 4,812,554
U.S. 5,221,619
U.S. 5,420,020
U.S. 5,583,013
Exhibit 99.2
Press Release |
|
Genentech and IDEC Announce Humanized Anti-CD20
Antibody Development Collaboration
Friday June 20, 4:19 pm ET
SOUTH SAN FRANCISCO, Calif. and SAN DIEGO(BUSINESS WIRE)June 20, 2003Genentech, Inc. (NYSE:DNA - News) and IDEC Pharmaceuticals Corporation (Nasdaq:IDPH - News) today announced plans to develop one or more new humanized anti-CD20 antibodies targeting B-cell disorders for a broad range of indications. Financial terms of the profit-sharing collaboration were not disclosed.
Genentech and IDEC plan to file an investigational new drug application (IND) on their first humanized anti-CD20 antibody by the end of this year. The companies plan to work efficiently together to develop and commercialize additional anti-CD20 products that are targeted for specific patient populations, depending on the severity of their B-cell disorder. The primary focus of this collaboration will be to develop and launch a humanized anti-CD20 molecule while evaluating the utility for more efficacious follow-on humanized molecules.
Humanized anti-CD20 antibodies work by binding to a particular protein (the CD20 antigen) on the surface of normal and malignant B-cells. From there, they recruit the bodys natural defenses to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.
This will be the second collaboration between Genentech and IDEC. In 1995, Genentech and IDEC signed an agreement to develop and market Rituxan® (Rituximab), a chimeric anti-CD20 antibody. In November 1997, Rituxan became the first recombinant antibody to receive U.S. Food and Drug Administration (FDA) approval for cancer in the United States, and in 2002, had sales of more than $1 billion. More than 300,000 patients have been treated to date with Rituxan worldwide. Rituxan is indicated for the single-agent treatment of relapsed or refractory low-grade or follicular, CD20-positive, B-cell non-Hodgkins lymphoma (NHL).
We are delighted to broaden our already successful collaboration with Genentech, said William R. Rohn, IDECs president and chief operating officer. Our plan to develop a humanized anti-CD20 antibody is both an opportunity to strengthen our current oncology franchise as well as to extend it into a variety of autoimmune disease indications.
This collaboration should help the companies to continue to play a leading role in addressing B-cell disorders, said Joseph S. McCracken, vice president of Business and Commercial Development of Genentech. We look forward to expanding our relationship with IDEC and developing one or more new molecules that may provide significant benefit to patients with B-cell mediated diseases.
About IDEC Pharmaceuticals
IDEC Pharmaceuticals Corporation is a leader in the discovery, development, and commercialization of targeted immunotherapies for the treatment of cancer and autoimmune diseases. IDEC discovered and developed the first commercially available radioimmunotherapy product (Zevalin(TM)) approved in the United States, which is used to treat certain types of B-cell non-Hodgkins lymphoma. IDEC also discovered and, with co-promotion partner Genentech, Inc., developed the first monoclonal antibody product (Rituxan®) approved in the United States for the treatment of cancer. Rituxan is approved in over 70 countries worldwide and is also used to treat various types of B-cell non-Hodgkins lymphoma. Based in San Diego, IDEC is an integrated biopharmaceutical company with multiple products in
clinical stage development and strategic alliances in a variety of research platforms. For press releases and additional information about the company, please visit http://www.idec.com.
About Genentech
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Fifteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes ten biotechnology products in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA. For press releases and additional information about the company, please visit http://www.gene.com.
The statement made in this press release relating to the filing of an IND on the first humanized anti-CD20 antibody by the end of this year is forward-looking and the actual time frame could vary materially. Among other things, the IND filing could be affected by preclinical toxicity or efficacy issues or discussions with the FDA.
Contact:
Genentech, Inc.
Media Contact:
Mark V. Krajnak, 650/225-2792
Investor Contact:
Kathee Littrell, 650/225-1034
or
160; IDEC
Media/Investor Contact:
Vince Reardon, 858/431-8801