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10-Q - 10-Q - AMGEN INCamgn-2014630x10q.htm
EXCEL - IDEA: XBRL DOCUMENT - AMGEN INCFinancial_Report.xls
EX-32 - SECTION 1350 CERTIFICATIONS - AMGEN INCamgn-ex32_2014630xq2.htm
EX-31 - RULE 13A-14(A) CERTIFICATIONS - AMGEN INCamgn-ex31_2014630xq2.htm


Exhibit 10.55












TERMINATION

AND TRANSITION AGREEMENT BY AND AMONG
AMGEN INC.

AND

AMGEN MANUFACTURING LIMITED AND
GLAXO GROUP LIMITED

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TERMINATION AND TRANSITION AGREEMENT



This Termination and Transition Agreement (this “Agreement”) is entered into on this 1st day of April 2014 by and between (1) Amgen Inc., a Delaware corporation with its principal place of business at 1 Amgen Center Drive, Thousand Oaks, CA 91320, USA (“Amgen Inc”), (2) Amgen Manufacturing Limited, a corporation incorporated under the laws of the Islands of Bermuda with its principal place of business at Canon’s Court, 22 Victoria Street, Hamilton, HM 12, Bermuda (“Amgen”), and (3) Glaxo Group Limited, registered in England as company number 305979, doing business as “GlaxoSmithKline” and having its principal office at 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom (“GSK”). Each of Amgen Inc, Amgen and GSK is sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

RECITALS


WHEREAS, Amgen Inc is a biotechnology company that researches, develops, manufactures and commercializes novel therapeutics to treat grievous illness;

WHEREAS, Amgen Inc has developed the proprietary product Ivory for the treatment of certain diseases and conditions;

WHEREAS, on 26 July 2009, Amgen Inc and GSK entered into (i) a collaboration agreement with respect to the commercialization of Ivory in the Collaboration Territory (as defined therein), as amended (collectively, the “Collaboration Agreement”) which is attached as Annex A hereto, and (ii) a separate expansion agreement whereby GSK agreed to commercialize Ivory as specified therein in the Expansion Territory (as defined therein) (the “Expansion Agreement”);

WHEREAS, Amgen Inc and GSK now desire to mutually terminate the Collaboration Agreement (but not the Expansion Agreement) and to transfer to Amgen and/or its Affiliates the activities assigned to GSK and related rights granted to GSK under the Collaboration Agreement in all countries of the Collaboration Territory except Australia, and to amend the Collaboration Agreement with respect to Australia in accordance with the terms set out herein; and

WHEREAS, Amgen requires, and GSK is willing to provide, certain services, assistance and support to Amgen and/or its Affiliates until completion of the transfer of all the activities assigned to GSK on the terms set out herein.

NOW, THEREFORE, in consideration of the premises and the mutual promises set forth herein, and intending to be legally bound, the Parties agree as follows:


1.
DEFINITIONS

1.1.
The following terms used in this Agreement shall have the meanings set forth below, and any other capitalized terms used but not otherwise defined in this Agreement shall have the meanings ascribed to such terms in the Collaboration Agreement.

1.1.1.
2014 Brand Plan” means the Brand Plan for Ivory established by the Joint Brand Team under the Collaboration Agreement for the year 2014.


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1.1.2.
“Agreement” has the meaning set out in the preamble to this Agreement.

1.1.3.
“Amgen” has the meaning set out in the preamble to this Agreement.

1.1.4.
“Amgen Inc” has the meaning set out in the preamble to this Agreement.

1.1.5.
“Amgen Indemnitees” means Amgen Inc, its Affiliates, and their respective directors, officers, employees, agents and representatives.

1.1.6.
“Amgen Reps” has the meaning set out in Section 5.2.2.

1.1.7.
“Anticipated Transition Date” has the meaning set out in Section 3.2.

1.1.8.
“Australia Agreement” has the meaning set out in Section 4.5.

1.1.9.
“Business Day” means a day on which banking institutions in London, England and Zurich, Switzerland are open for business, excluding any Saturday or Sunday and the nine (9) consecutive calendar days beginning on December 24th and continuing through January 1st.

1.1.10.
“Collaboration Agreement” has the meaning set out in the Recitals to this Agreement.

1.1.11.
“Collaboration Territory” has the meaning set out in the Recitals to this Agreement.

1.1.12.
“Commercially Reasonable Efforts” means, with respect to activities of a Party under this Agreement and the Transition Plan, the efforts and resources typically used by that Party in the conduct of such activities with respect to products of comparable market potential, taking into account all relevant factors, and, in any event, the exercise of no less than reasonable care, diligence and skill. For purposes of clarity, Commercially Reasonable Efforts will be determined on a country-by-country basis within the Transition Territory and shall take into consideration the anticipated Transition Date for each such country. Notwithstanding the foregoing, Commercially Reasonable Efforts will be deemed satisfied where the specific efforts outlined in the Transition Plan, if any, have been met.

1.1.13.
“CSOs” has the meaning set out in Section 5.2.2.

1.1.14.
“Effective Date” means 1 April 2014.

1.1.15.
“Employment Liabilities” means all wages, salaries, bonuses, commissions, employers’ national insurance contributions and other Taxes and other periodic outgoings (including pensions contributions) (or equivalent payment obligations) attributable to the employment of any employees, and all compensation, awards, losses, costs, claims, fines, penalties, damages, expenses (including legal and other professional expenses) or liabilities, including in respect of Taxes, relating to employment/termination of employment.

1.1.16.
“Expansion Agreement” has the meaning set out in the Recitals to this Agreement.

1.1.17.
“GSK” has the meaning set out in the preamble to this Agreement.

1.1.18.
“GSK Reps” has the meaning set out in Section 5.2.2.

1.1.19.
“GSK Staff” has the meaning set out in Section 10.2.1.

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1.1.20.
“Letter of Intent” means the letter of intent regarding the terms of the Australia Agreement, attached hereto as Schedule 4.5.

1.1.21.
“Material Activities” means the activities which are indicated to constitute Material Activities in the column entitled “Category” of the Transition Plan.

1.1.22.
“Material Change” means any changed market or economic condition, circumstance, or effect (i) that has had, or would reasonably be expected to have, individually or in the aggregate, a material effect on Ivory in any country or countries of the Transition Territory, (ii) that is capable of remedy through reasonable changes to the Transition Plan (subject always to GSK’s limit on Detailing as provided in the Country Plans implementing the 2014 Brand Plan for the applicable country) and such remedy cannot reasonably be effected without GSK’s participation, and (iii) that, without such remedy, would prevent GSK from performing or transferring Material Activities to Amgen or would prevent Amgen from assuming responsibility for Material Activities. Notwithstanding the foregoing, a “Material Change” shall not include any changed market or economic condition, circumstance or effect, individually or in the aggregate, (A) relating to the economy in general in the specific country or countries of the Transition Territory or in any jurisdiction in which Amgen or any of its Affiliates has operations or conducts business related to Ivory, or (B) affecting the pharmaceutical industry in general, including changes in Applicable Laws. Force Majeure events shall be handled in accordance with Section 15.4.

1.1.23.
“Milestone A” has the meaning set out in Section 3.6.

1.1.24.
“Milestone B” has the meaning set out in Section 3.6.

1.1.25.
“Notice Date” has the meaning set out in Section 13.1.

1.1.26.
“Other Activities” means the activities which are indicated to constitute Other Activities in the column entitled “Category” of the Transition Plan.

1.1.27.
“Party” has the meaning set out in the preamble to this Agreement.

1.1.28.
“Physicians” shall mean primary care physicians and secondary care physicians.

1.1.29.
“Product Data” means all data, reports, records and materials in the possession or control of GSK or its agents that relate to Ivory, which includes, but is not limited to, all such data which were provided to or generated by GSK and/or its Affiliates or its agents pursuant the Designated GSK Activities as well as any other commercial and non-commercial activities carried on by GSK and/or its Affiliates with respect to Ivory solely in the Collaboration Scope under the Collaboration Agreement or this Agreement, such as scientific and commercial materials, customer data relating to Ivory Detailing or other customer related activities (e.g., Physician personal data), market research information and any on-going patient research carried out by or on behalf of GSK or its Affiliates. For the avoidance of doubt, “Product Data” shall not include any of the foregoing categories of information to the extent it was in GSK’s possession prior to the Effective Date of the Collaboration Agreement (except to the extent used by GSK under the Collaboration Agreement, provided that GSK shall have the right to redact the same to exclude any information that GSK reasonably deems proprietary to it), or was otherwise generated by GSK outside of the Collaboration Agreement or this Agreement. Furthermore, notwithstanding the scope of the definition of “Product Data,” GSK shall be required to transfer only the Product Data set forth in the Transition Plan, subject to, and in accordance with all of the requirements, of Section 4.1.1.

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1.1.30.
“PV Agreement” means the First Amended and Restated Safety Agreement between Amgen Inc and GSK concerning the Collaboration Territory dated 15 July 2013.

1.1.31.
“Rules” has the meaning set out in Section 15.1.

1.1.32.
“Services Payment” has the meaning set forth in Section 9.2.

1.1.33.
“Term” has the meaning set out in Article 13.1.

1.1.34.
“Termination Payment” has the meaning set out in Section 9.1.1.

1.1.35.
“Transition” has the meaning set out in Section 3.2.

1.1.36.
“Transition Budget” has the meaning set forth in Section 3.4.

1.1.37.
“Transition Date” means the date as determined in accordance with Section 3.6.

1.1.38.
“Transition Manager” has the meaning set out in Section 5.1.2.

1.1.39.
“Transition Plan” means the transition plan set forth on Schedule 3.4(a).

1.1.40.
“Transition Territory” has the meaning set out in Section 2.1.1.

1.2.
References to Articles, Sections and Schedules are to articles, sections and schedules of this Agreement unless otherwise specified. Headings and captions in Articles, Sections and Schedules are inserted for convenience of reference only and are not intended to be part of or affect the meaning or the interpretation of this Agreement.

1.3.
Article 1 of the Collaboration Agreement (Definitions) shall survive termination of the Collaboration Agreement and is incorporated by reference into this Agreement to the extent required in order to give effect to the other surviving provisions of the Collaboration Agreement.

1.4.
With respect to any provision of the Collaboration Agreement that is expressly incorporated by reference into this Agreement, the terms “Agreement”, “Effective Date”, “Term” or “Parties” shall have the meanings set out in this Agreement, unless the context otherwise requires.

2.
TERMINATION OF THE COLLABORATION AGREEMENT

2.1.
Mutual Termination. GSK and Amgen Inc hereby agree that:

2.1.1.
the Collaboration Agreement is unconditionally and irrevocably terminated as of midnight US Eastern time March 31, 2014, with respect to all countries in the Collaboration Territory except for Australia (the “Transition Territory”); and

2.1.2.
the provisions of this Agreement shall apply as from the Effective Date solely with respect to theTransition Territory.

2.2.
Survival. Except (i) with respect to the Transition Territory, to the extent and for the periods expressly set out in Schedule 2.2 or elsewhere in this Agreement, and (ii) with respect to Australia, the provisions of the Collaboration Agreement shall not survive termination of the Collaboration Agreement.


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2.3.
References to Termination and Collaboration Scope. All references in this Agreement to termination of the Collaboration Agreement shall be deemed to refer to termination of the Collaboration Agreement solely with respect to the Transition Territory and shall not include termination with respect to Australia. References to Collaboration Scope in this Agreement to define the Parties’ obligations hereunder shall mean the Collaboration Scope solely as it applies to the Transition Territory.

2.4.
No Release from Pre-Existing Liability. Termination of the Collaboration Agreement hereunder will not release either GSK or Amgen Inc from any liability (including any payment obligations) that, at the time of the Effective Date, has already accrued to GSK or Amgen Inc., respectively, or which is attributable to activities under the Collaboration Agreement prior to the Effective Date.


3.
GENERAL OBLIGATIONS OF THE PARTIES UNDER THIS AGREEMENT

3.1.
Mutual Cooperation. The Parties’ intent with regard to their respective rights and obligations under this Agreement is to effect a complete and timely transition that ensures reasonable continuity in the promotion and commercialization of Ivory in the Collaboration Scope in each country of the Transition Territory and the maintenance of key customer and stakeholder relationships during the Transition. The Parties and their respective Affiliates shall reasonably cooperate with each other in connection with the performance of the Transition activities contemplated in this Agreement, including making available on a timely basis to the other Party such personnel, information or records (or copies thereof) as may be reasonably requested with respect thereto (as well as any material updates to any information previously provided), provided that such cooperation shall not unreasonably disrupt the normal operations of the Parties and their respective Affiliates.

3.2.
GSK Obligation. GSK shall provide (and/or cause one or more of its Affiliates to provide) to Amgen or its Affiliates the following services during the Term: GSK will use Commercially Reasonable Efforts to effect a smooth and orderly transition of Material Activities and Other Activities to Amgen or its Affiliates, as set forth in this Agreement and the Transition Plan by the date set forth for each country in Schedule 3.2 (each such date, an “Anticipated Transition Date”) or by December 31, 2014 (the “Transition”). GSK will use Commercially Reasonable Efforts to meet its obligations to execute Designated GSK Activities within the Collaboration Scope solely if, and to the extent, provided in the Transition Plan or otherwise in this Agreement. For the avoidance of doubt, the Country Plans implementing the 2014 Brand Plan provide the maximum level of GSK Designated Activities that GSK will be required to perform under the Transition Plan with respect to the applicable country, and under no circumstances, including amendments to the Transition Plan in accordance with Section 3.4.2, shall GSK be required to conduct Details in any country of the Transition Territory in excess of those set forth in such Country Plans. If GSK and its Affiliates perform some or all of their services hereunder through Third Parties, to the extent permitted under this Agreement, GSK will be responsible for compliance by its Affiliates and such Third Parties with this Agreement and will be responsible for all acts and omissions of such Affiliates and Third Parties as if committed or omitted by GSK.

3.3.
Amgen Obligation. Amgen Inc and Amgen will use Commercially Reasonable Efforts to meet their respective obligations as further outlined in this Agreement and the Transition Plan, in cooperation with GSK, to ensure that the Transition is effected in a smooth and orderly manner and within the timeframe specified therein. Without limiting the foregoing, if GSK is required to complete a task in a specified timeframe in the Transition Plan or this Agreement, and such timing is subject to agreement of, or actions or responses by Amgen or Amgen Inc., then Amgen or Amgen Inc., as applicable, shall use Commercially Reasonable Efforts to agree, act or respond in a manner that does not impact GSK’s ability to carry out its obligations under the Transition Plan and this Agreement in the timelines agreed by Amgen Inc and GSK. Amgen or Amgen Inc and their respective Affiliates shall have the right to perform



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all such actions themselves or through such Third Parties as they may wish to engage in their sole discretion; provided, that Amgen or Amgen Inc will be responsible for compliance by such Affiliates and Third Parties with this Agreement and will be responsible for all acts and omissions of such Affiliates and Third Parties as if committed or omitted by Amgen or Amgen Inc..

3.4.
Transition Plan.

3.4.1.
As of the Effective Date, the Parties have mutually agreed to the Transition Plan attached hereto as Schedule 3.4(a) that governs the conduct of Material Activities and Other Activities by GSK, Amgen Inc and Amgen across all countries in the Transition Territory. In addition, the Parties have agreed to country-specific budgets applicable to the conduct of the Transition in such country, which are attached hereto as Schedule 3.4(b) (the “Transition Budget”). Notwithstanding the foregoing, the Country Teams may agree to conduct activities in addition to the requirements of the Transition Plan, which additional activities will be communicated to the Transition Managers; provided, that (a) non-performance of any additional activities agreed by a Country Team shall not affect payment of the Termination Payment to GSK, which shall be based solely on completion of the Material Activities that have been defined as of the Effective Date as provided in Section 9.1, and such additional activities shall not be included in the Transition Budget; and (b) the Service Payment payable to GSK under Section 9.2 shall be deemed to cover all items in the Transition Budget, regardless of the actual amounts budgeted or spent.

3.4.2.
None of the Parties may make unilateral changes to the Transition Plan; provided that the Parties may from time to time make such changes to the Transition Plan as they mutually agree in writing as described in this Section 3.4.2. If a Party desires to amend the Transition Plan, then the Transition Manager for such Party shall discuss such change with the Transition Manager from the other Party. If the Transition Managers agree to amend the Transition Plan, then Amgen’s Transition Manager shall promptly notify the Country Teams of the same in writing as approved by GSK’s Transition Manager. The Transition Managers are not required to agree to any amendment to the Transition Plan, and in the event the Transition Managers cannot agree to any particular amendment, the status quo shall apply save as provided below in this Section 3.4.2. Notwithstanding the foregoing, if a Material Change occurs in a country of the Transition Territory prior to the Anticipated Transition Date that was not reasonably foreseeable as of the Effective Date, then either Amgen or GSK may request the other Party to amend the Transition Plan, solely with respect to the country or countries that are affected by such Material Change, in a manner that reasonably addresses the changed circumstances and that seeks to achieve their respective intentions in entering into this Agreement, and the Party to whom such request has been made shall not unreasonably withhold or delay its consent to the requested amendment. For the avoidance of doubt, the decision-making provisions of the Collaboration Agreement do not apply to the amendment of the Transition Plan.

3.4.3.
GSK shall provide a report to Amgen not later than June 15, 2014 setting forth the estimated budget allocated by GSK to conduct the Transition in respect of the third calendar quarter of 2014; for the avoidance of doubt, the column entitled “Q2” in the Transition Budget covers such information for the second calendar quarter of 2014. In addition, not later than July 15, 2014 and October 15, 2014, respectively, GSK shall provide a report to Amgen showing the costs incurred by GSK on a country-by-country basis to conduct the Transition in respect of the second calendar quarter and third calendar quarter of 2014, respectively. Each of the reports described herein shall be delivered to Amgen’s Transition Manager, and shall reflect the information in US Dollars, split between “Direct Operating Expenses and “FTE Expenses”.


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3.5.
Other. The following provisions shall apply in respect of the Parties’ activities within the Collaboration Scope and the Transition during the Term:

3.5.1.
the provisions of this Agreement, including certain provisions of the Collaboration Agreement that are stated in Schedule 2.2 or elsewhere in this Agreement to survive and are accordingly incorporated by reference herein (including as amended by this Agreement), shall apply to all countries within the Transition Territory;

3.5.2.
to the extent that there is any inconsistency between the Transition Plan and the remaining provisions of this Agreement, the remaining provisions of this Agreement will control; and

3.5.3.
the PV Agreement shall remain in full force and effect during the Term of this Agreement and thereafter in accordance with section 11.7 of the PV Agreement.

3.6.
Determination of Transition Date; Milestones. The date on which completion of all of the Material Activities set out in the Transition Plan with respect to a particular country has occurred, as agreed in writing by the Transition Managers based on the recommendation of the applicable Country Team, shall be deemed the “Transition Date” for such country. The Parties will use Commercially Reasonable Efforts to align the Transition Date for such country with the Anticipated Transition Date for such country. GSK shall notify Amgen in writing when it reasonably believes that it has completed all of the Material Activities set out in the Transition Plan with respect to a country. If, after receipt of such notice the Country Team or Transition Managers cannot agree that the Material Activities have been completed, then Amgen shall provide written notice in sufficient detail to GSK explaining what Material Activity has not been completed. If GSK receives such written notice and GSK disagrees with Amgen’s assertion, then GSK, Amgen or Amgen Inc may refer such disagreement for resolution in accordance with Section 15.1. “Milestone A” shall be deemed to have been achieved upon occurrence of the Transition Date in respect of all the countries set forth on Schedule 9.1.1.2 (as determined by the Transition Managers or in accordance with Section 15.1) and “Milestone B” shall be deemed to have been achieved upon occurrence of the Transition Date in respect of all the countries set forth on Schedule 9.1.1.3 (as determined by the Transition Managers or in accordance with Section 15.1).

4.
SPECIFIC TRANSITION ACTIVITIES

4.1.
Transition Activities. GSK, Amgen and Amgen Inc and/or each of their respective Affiliates shall use Commercially Reasonable Efforts to conduct the Material Activities and Other Activities set forth in the Transition Plan as described in Article 3, and in accordance with the specific provisions of this Article 4.

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4.1.1.
Transfer of Product Data.

4.1.1.1.
GSK will transfer to Amgen or its designee, at no cost, all Product Data that is specifically described in the Transition Plan with the goal of completing such transfer by the Anticipated Transition Date and in accordance with this Section 4.1.1. Transfers of Product Data will be in electronic format reasonably usable by Amgen, unless otherwise agreed between the Parties, acting reasonably, and will include original hardcopies or duplicate copies thereof if legally required. For Product Data in electronic format, the Parties shall use such system as may be mutually agreed by the Parties for such purpose and such system shall remain active until all Material Activities are completed in all countries of the Transition Territory. Product Data will be exchanged via common industry-standard interchange formats wherever possible, and the final form and format shall be agreed between the Parties prior to each data transfer; provided, that GSK shall be permitted to return Product Data to Amgen in the same format in which it was provided to GSK (solely where such format was not subsequently materially amended by GSK), without further modification or discussion with Amgen.

4.1.1.2.
Notwithstanding the foregoing or anything to the contrary in this Agreement or the Transition Plan, GSK shall be responsible for transfer of Product Data to the extent permitted by Applicable Laws, including data privacy laws applicable in each country of the Transition Territory. Where such Applicable Laws require either consent of an individual or notification to or approval of a local data privacy authority to transfer such Product Data, then GSK shall use the specific efforts as set forth in the Transition Plan to obtain such consent or approval or to make such notification; provided, that Amgen or its Affiliates shall provide reasonable assistance as requested by GSK. GSK shall provide to Amgen within two (2) Business Days of the Effective Date copies of the Transition Territory country-specific data privacy consent forms that GSK sends to Physicians in those countries. Where consent or approval cannot be obtained using the efforts set forth in the Transition Plan, such Product Data shall not be transferred to Amgen, and GSK’s obligation with respect to such Material Activity shall be deemed satisfied.

4.1.1.3.
GSK shall have no obligation to take steps to transfer Product Data that is in the possession of Amgen or Amgen Inc (as promptly confirmed in writing by Amgen or Amgen Inc., as applicable, or as determined as set forth in the Transition Plan), or resides on the existing Sharepoint site or Amgen Media Portal.

4.1.1.4.
Amgen will comply with Applicable Laws, including data privacy laws, with respect to the processing and storing of Product Data received from GSK under this Agreement.

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4.1.2.
Detailing Activities. In accordance with the Transition Plan and this Agreement, GSK shall continue to Detail Ivory in each country of the Transition Territory within the Collaboration Scope and to conduct the Designated GSK Activities until the Transition in respect of such country is completed in accordance with this Agreement. GSK shall ensure that representatives of GSK and/or its Affiliates and/or any CSO (as defined below) engaged by or on behalf of GSK and/or its Affiliates fulfill and document completion of all Details per representative that is stipulated in the Transition Plan, which number of Details shall not be more than GSK would be obligated to conduct in the same period in the same country under the existing agreed 2014 Brand Plan as implemented by the applicable Country Team, and no new coverage or frequency shall be required.

4.1.3.
Customer Introduction. GSK will use Commercially Reasonable Efforts to facilitate a face-to- face introduction between each Physician to which it Details Ivory and an Amgen Rep; provided that such Physician consents to such introduction in accordance with Section 4.1.1.2, as further described in this Section 4.1.3 and the Transition Plan. After transfer of Product Data described in Line Refs. 1 and 2 of the Transition Plan to Amgen or its Affiliates, the Country Teams shall meet to agree on prioritization of introductions and a schedule for such introductions. If the Country Team cannot agree on prioritization, Amgen shall have the final decision with respect to which Physicians to prioritize. For the avoidance of doubt, if introductions are not possible because consent was not obtained, then GSK’s obligation to facilitate such meeting shall be deemed satisfied. Further, if any Physician provides consent in accordance with Section 4.1.1.2 after the time period for response set out in the Transition Plan, then GSK shall nevertheless use Commercially Reasonable Efforts to facilitate an introduction between the Amgen Rep and such Physician. In addition, GSK shall provide to Amgen the Product Data for which it has consent to transfer regardless of when consent is received, until December 31, 2014. In all cases, the meeting schedule shall take into account the number of introductions that can reasonably occur within the time period remaining before the Anticipated Transition Date for the applicable country, and the number of Details to be performed during that period. Notwithstanding the foregoing, Amgen shall instruct all Amgen Reps that attend a face-to-face introduction that they are not permitted to be in attendance with a GSK Rep for such portion of any Detail call during which the GSK Rep is Detailing products other than Ivory (e.g., the Amgen Rep would step out of the call or meeting during that portion), and all such Amgen Reps shall not be permitted to attend such portion of any Detail call during which the GSK Rep is Detailing products other than Ivory.

4.2.
Applicable Collaboration Agreement Provisions. The provisions of the Collaboration Agreement set out in and amended by Schedule 2.2 that relate to ‘Promotional Materials’ (Section 3.10), ‘Reporting’ (Section 3.11.1), ‘Medical Inquiries and Product Inquiries’ (Section 3.12), ‘Samples’ (Section 3.13), ‘Diligence and Performance Standards’ (Section 4.2), ‘Violation of Laws’ (Section 4.4), ‘Use of Affiliates and Third Party Contractors’ (Section 4.5), ‘Affiliates’ (Section 4.6) and ‘Management of Personnel’ (Section 4.7) shall survive termination of the Collaboration Agreement and are incorporated by reference herein, but with respect to GSK, solely to the extent such provisions apply to the conduct of the Transition Plan in accordance with this Agreement.

4.3.
Default Allocation of Responsibilities. To the extent that the responsibility of the Parties is not otherwise regulated by the terms of the Transition Plan or this Agreement, the provisions of the Collaboration Agreement set out in and amended by Schedule 2.2 that relate to ‘All Sales by Amgen’ (Section 3.7), ‘Training’ (Section 3.8) and ‘Non-Commercial Activities’ (Section 3.14) shall survive termination of the Collaboration Agreement and are incorporated by reference herein, but with respect to GSK, solely to the extent such provisions apply to the conduct of the Transition Plan in accordance with this Agreement.

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4.4.
Amended and Restated Collaboration Agreement for Australia. The Parties shall enter into an Amended and Restated Collaboration Agreement with respect to the Detailing and commercialization of Ivory in Australia, on or before September 1, 2014 (the “Australia Agreement”), as further described in the Letter of Intent attached hereto as Schedule 4.5.

5.
GOVERNANCE

5.1.
Governance bodies.

5.1.1.
The following bodies as established under the Collaboration Agreement shall remain in operation during the Term to govern the activities of the Parties under this Agreement (provided to the extent that a body is responsible for a specific country, then such body shall cease to operate after the Transition Date relating to that country (-ies) unless otherwise agreed between the Parties): (i) each Country Team, and (ii) the Patent Coordinators.

5.1.2.
In addition, Amgen and GSK shall each appoint a single transition manager (“Transition Manager”), who shall have the responsibilities set out in Section 5.4.

5.1.3.
Subject to the terms of this Agreement and Applicable Laws, the decisions of such teams and committees will be made with the interests of effecting a smooth and orderly Transition, and in accordance with the discretion and business judgment of the members thereof, acting in good faith.

5.2.
Country Teams.

5.2.1.
Each Country Team as established under the Collaboration Agreement will be responsible for: (i) implementing and overseeing the Transition in accordance with this Agreement, the Transition Plan in their relevant country(-ies), the Transition Budget and the Anticipated Transition Date applicable to such country; (ii) coordinating the review of any Promotional Materials and training materials to be used to train GSK representatives that are Detailing Ivory during the Term, subject to the last sentence of this Section 5.2.1; and (iii) promptly notifying the Transition Managers in writing when all of the Material Activities set out in the Transition Plan that is/are expressed to relate to such country(-ies) have, in their view, been completed. Each Country Team will also be the appropriate forum to discuss terms of the Transition Plan that applies(-y) to it. For the avoidance of doubt, the Parties do not expect the generation or development of any new Promotional Materials for use by GSK Reps during the Term of this Agreement, except to communicate changes to Ivory’s label as required by Regulatory Authorities and all such materials will be subject to review by GSK’s commercial and medical functions prior to use by GSK Reps.

5.2.2.
The members of each Country Team shall have the right to invite non-members of the Country Team to attend meetings if needed to fulfill particular objectives of such meeting. Such non- member representatives shall include sales representatives of Amgen and/or its Affiliates and/or any contract sales organizations (or similar entities) (“CSOs”) engaged by or on behalf of Amgen and/or its Affiliates to Detail Ivory in the Collaboration Scope (the “Amgen Reps”) and representatives of GSK and/or its Affiliates and/or any CSO engaged by or on behalf of GSK and/or its Affiliates (the “GSK Reps”) for the purposes of ensuring proper communication regarding handover issues.

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5.2.3.
The provisions of the Collaboration Agreement set out in and amended by Schedule 2.2 that relate to ‘Meetings’ (Section 2.13.1), ‘Reporting’ (Section 2.13.2) and ‘Decision Making’ (Section 2.13.3) shall survive termination of the Collaboration Agreement and are incorporated by reference herein.

5.2.4.
As at the Effective Date, the membership of the Country Teams shall remain the same as prior to termination of the Collaboration Agreement.

5.3.    Patent Coordinators.

5.3.1.
The provisions of the Collaboration Agreement set out in Schedule 2.2 that relate to Patent Coordinators (Section 2.14) shall survive termination of the Collaboration Agreement and are incorporated by reference herein.

5.3.2.
As of the Effective Date, the Patent Coordinators shall remain the same and shall have the same scope of responsibility as prior to termination of the Collaboration Agreement, as amended as set forth in Schedule 2.2.

5.4.    Transition Managers.

5.4.1.
The Transition Managers will oversee the Parties’ interactions in between meetings of the Country Teams. The responsibilities of the Transition Managers shall consist of the following: (i) overseeing the Transition; (ii) directing and monitoring the implementation of the Transition Plan in accordance with their terms and this Agreement; (iii) encouraging and facilitating the co- operation and communication between the Parties on a day-to-day basis as it relates to this Agreement; (iv) resolving any issues that cannot be solved by the Country Teams; and (v) any other matters set forth to be within their remit under this Agreement. The Transition Managers will be the primary contact point between the Parties with respect to all matters arising during the Transition activities, and shall coordinate the Transition activities undertaken by the Parties, unless otherwise agreed herein. Each Party may replace its Transition Manager at any time upon giving no less ten (10) calendar days prior written notice to the other Party.

5.4.2.
The Transition Managers shall initially be: Beppe Cangelosi (appointed by Amgen) and Dipal Patel (appointed by GSK).

5.4.3.
The Transition Managers shall meet (by teleconference or video conference or otherwise) on a weekly or other reasonable regular basis as agreed upon by Amgen and GSK. Subject to the last sentence of Section 5.4.1, the Transition Managers shall remain in place until completion of the Transition activities or earlier, if agreed by Amgen and GSK. The first meeting will be held no later than fifteen (15) days after the Effective Date.

5.4.4.
The Transition Manager appointed by Amgen shall chair all meetings and shall be responsible for designating a secretary to record in reasonable detail and to circulate draft minutes of meetings to the Transition Managers for comment and review within five (5) calendar days after the relevant meeting. The Transition Managers jointly shall approve the final version of the minutes.


12



5.5.
Any material issues that cannot be resolved by the Transition Managers will be referred for mutual discussion and resolution to one (1) senior management member from each of Amgen and GSK (being a Vice President (or his or her designee) in the case of Amgen and SVP & Head of Europe Commercial Area (or his or her designee) in the case of GSK); provided that if no such resolution can be reached after good faith negotiation, then (subject to amendments due to Material Changes as set forth in Section 3.4.2) the status quo applies with respect to the conduct of activities under the Transition Plan; and provided, further that if the dispute concerns matters that affect Ivory on an above country level such as a safety issue, then in such case the final decision will be made by the Amgen senior management member. For clarity (and without prejudice to Section 3.4.2), the Amgen senior management member shall not have any authority to (i) amend the Transition Plan; (ii) increase the number of GSK FTEs or Details to be conducted by GSK in any country in the Transition Territory; (iii) determine unilaterally whether or not GSK has completed Material Activities or Other Activities as set forth in the Transition Plan; and (iv) require GSK to conduct any activity or use any materials in conflict with Applicable Laws or GSK’s internal policies or procedures. Any disagreements between Amgen and GSK regarding the subject matter set forth in the previous sentence may be resolved in accordance with Section 15.1.

5.6.
Appropriate Authority. Each of Amgen and GSK will ensure that the persons appointed by it to the aforementioned governance bodies have the appropriate level of seniority and decision-making authority to perform their respective appointed responsibilities. Furthermore, notwithstanding anything herein to the contrary, none of the aforementioned governance bodies will have any authority to amend, modify or waive compliance with this Agreement.

5.7.
Other Provisions. The provisions of the Collaboration Agreement set out in Schedule 2.2 that relate to ‘Internal Governance’ (Section 2.17) shall survive termination of the Collaboration Agreement and are incorporated by reference herein.

6.
DISTRACTING PRODUCTS

6.1.
The provisions of the Collaboration Agreement set out in and amended by Schedule 2.2 that relate to ‘Distracting Products’ (Article 8) shall survive termination of the Collaboration Agreement and are incorporated by reference herein.

7.
INTELLECTUAL PROPERTY MATTERS

7.1.
Continuing Cross-Licences; Ownership. The provisions of the Collaboration Agreement set out in and amended by Schedule 2.2 that relate to ‘Training’ (Section 3.8), ‘Information Concerning Ivory’ (Section 3.9), ‘Promotional Materials’ (Section 3.10), ‘Invention Ownership’ (Section ), ‘Copyright Ownership; Certain Confidential Information’ (Section 9.2), ‘Joint Ownership’ (Section 9.3), ‘License Grant by Amgen’ (Section 9.4), ‘License Grant by GSK’ (Section 9.5), ‘Prosecution and Maintenance’ (Section 9.6), ‘Defense and Settlement of Third-Party Claims of Infringement’ (Section 9.7), ‘Enforcement’ (Section 9.8), ‘Patent Term Extensions’ (Section 9.9), ‘Employee Agreements’ (Section 9.10), and ‘Trademarks’ (Section 9.11) shall survive termination of the Collaboration Agreement and are incorporated by reference herein.

7.2.
Assignment of IP Registrations. GSK will promptly, at its own expense (other than with respect to any fee payable to the relevant Governmental Authority in connection with the relevant assignment, which will be borne by Amgen), assign to Amgen all trademark and copyright registrations related to Ivory in the Collaboration Scope (or to labeling, package inserts or outserts, monographs or packaging materials or Promotional Materials for Ivory) that are in GSK’s name, if any. The foregoing is not meant to imply any right of GSK to own any filing or intellectual property except as may be expressly set forth in the Collaboration Agreement or this Agreement or agreed in writing between the Parties.

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7.3.
Right to Use GSK Housemarks. In addition to Section 7.1 and Schedule 2.2, Amgen and its Affiliates shall have the right to use the GSK Housemarks as they appear on Product labels for such period of time as is required to complete variations and label changes to remove the GSK Housemarks. For the avoidance of doubt, the time periods specified for use by Amgen of GSK Housemarks in Section 9.11.3.2 of the Collaboration Agreement (with respect to Promotional Materials) and Section 14.9.2 of the Collaboration Agreement (with respect to labeling, package inserts or outserts, monographs, packaging materials and Promotional Materials) shall apply, mutatis mutandis, to the depletion by Amgen of inventory of Ivory bearing GSK Housemarks. Amgen and its Affiliates shall use Commercially Reasonable Efforts to complete all such variations and label changes by the Anticipated Transition Date for each country of the Transition Territory and in no event later than December 31, 2014; provided, that, solely with respect to Mexico, the Parties acknowledge and agree that the right of Amgen and its Affiliates to use the GSK Housemarks as they appear on Product labels shall continue after December 31, 2014 for so long as required to allow for removal of GSK Housemarks from the Product label in Mexico in accordance with Applicable Laws.

7.4.
Access to Database. During the Term of this Agreement, GSK shall continue to permit Amgen and its Affiliates to have access to the existing ZINC database solely for the purpose of and as necessary for, retrieval by Amgen and its Affiliates of Product Data or GSK’s transfer of Product Data to Amgen or its Affiliates.

8.
REGULATORY AND SAFETY; CONFIDENTIALITY

8.1.
General. The provisions of the Collaboration Agreement set out in and amended by Schedule 2.2 that relate to ‘Regulatory Matters - Communication and Filings’ (Section 10.1.1), ‘Regulatory Matters - GSK Obligations’ (Section 10.1.3), ‘Regulatory Matters - Labeling and Packaging Materials’ (Section 10.1.4), ‘Regulatory Matters - Regulatory and Safety Information’ (Section 10.1.5), ‘Brand Security and Anti- Counterfeiting’ (Section 10.2), ‘Product Technical Complaints; Recalls; and Returns’ (Section 10.3), ‘Confidentiality; Exceptions’ (Section 11.1), ‘Authorized Disclosure’ (Section 11.2), ‘Confidential Treatment of Terms and Conditions’ (Section 11.3), ‘Publications and Program Information’ (Section 11.6), ‘Attorney-Client Privilege’ (Section 11.7), and ‘Injunctive Relief’ (Section 11.8) shall survive termination of the Collaboration Agreement and are incorporated by reference herein. Following termination of this Agreement, medical inquiries with respect to Ivory will be referred by GSK to Amgen in accordance with instructions provided by Amgen.

8.2.
Transfer of Regulatory Filings. Promptly after the Effective Date, GSK will notify Amgen in writing of any Regulatory Filings in the Transition Territory related to Ivory that are in GSK’s possession in each country that were generated from regulatory activities that were: (a) led jointly by Amgen or its Affiliates and GSK; or (b) led by GSK in Croatia prior to its accession to the European Union. Amgen or its Affiliates shall respond to GSK in writing identifying the Regulatory Filings that Amgen or its Affiliates does not possess in accordance with the specific timelines set forth in the Transition Plan; provided, that if GSK does not receive a response within such timelines, then GSK’s obligation to transfer Regulatory Filings shall be deemed satisfied. If Amgen or its Affiliates identifies Regulatory Filings to be transferred, then GSK shall promptly transfer to Amgen or its Affiliates, at its own expense (other than with respect to any fee payable to the relevant Governmental Authority in connection with the relevant transfer, which will be borne by Amgen or its Affiliates), all such identified Regulatory Filings.

8.3.
Cooperation and Support. During the Term, each Party will provide such cooperation as legally required or otherwise mutually agreed in order to effect the completion of the Material Activities and Other Activities related to Regulatory Filings and Regulatory Approvals, including the transfer of Regulatory Filings from GSK to Amgen and the removal of GSK Housemarks from the Product label.

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8.4.
Supplemental Regulatory Filings and Approvals. To the extent that Amgen or its Affiliates are required to obtain any Regulatory Filings and Regulatory Approvals to effect the Transition, Amgen or its Affiliates shall use Commercially Reasonable Efforts to obtain these (at its sole expense) as soon as practicable; provided, that GSK shall not be liable for any delays to the completion of Material Activities or Other Activities by GSK hereunder that are caused by an obligation of Amgen or its Affiliates under this Section 8.4.

9.
FINANCIAL TERMS

9.1.
Termination Payment.

9.1.1.
Amgen shall pay to GSK the following non-refundable, non-creditable amounts (together, the “Termination Payment”) in the following installments:

9.1.1.1.
USD 75,000,000 (seventy five million), payable within five (5) Business Days following the Effective Date;

9.1.1.2.
USD 75,000,000 (seventy five million), payable within five (5) Business Days following the date on which it is agreed by the Transition Managers (or as determined in accordance with Section 15.1 if applicable) in accordance with Section 3.6 that Milestone A has been achieved;

9.1.1.3.
USD 75,000,000 (seventy five million), payable within five (5) Business Days following the date on which it is agreed by the Transition Managers (or as determined in accordance with Section 15.1 if applicable) in accordance with Section 3.6 that Milestone B has been achieved; and

9.1.1.4.
USD 50,000,000 (fifty million), payable within five (5) Business Days following the date on which it is agreed by the Transition Managers (or as determined in accordance with Section 15.1 if applicable) in accordance with Section 3.6 that all Material Activities in all countries of the Transition Territory other than those listed in Milestone A and Milestone B have been achieved.

9.1.2.
The provisions of the Collaboration Agreement set out in Schedule 2.2 that relate to ‘Payments’ (Article 7) shall survive termination of the Collaboration Agreement and are incorporated by reference herein.

9.2.
Services Payment. Amgen shall pay to GSK a non-refundable, non-creditable payment of USD 15,000,000 (fifteen million) (the “Services Payment”) within five (5) Business Days following the Effective Date, in full and complete consideration for all of the Transition activities performed by GSK hereunder, as set forth in the Transition Budget.

9.3.
The payments set forth in Sections 9.1 and 9.2 shall be payable by wire transfer of immediately available funds in accordance with wire transfer instructions of GSK provided in writing to Amgen on or prior to the Effective Date. GSK shall send all invoices under this Agreement to Amgen Manufacturing Limited Road 31 km 24.6, Juncos, Puerto Rico 00777-4060, attention to: President and General Manager.


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9.4.
The Parties hereby acknowledge and agree that, notwithstanding any provision of the Collaboration Agreement, the Termination Payment and the Services Payment are the aggregate amount payable by Amgen to GSK in connection with the mutual termination of the Collaboration Agreement pursuant to this Agreement. Except as expressly set out in this Agreement, neither Amgen nor any of its Affiliates shall be liable to pay any additional fees, milestone payments, tail payments, termination buy-out payments, royalties or other payments of any kind to GSK or any of its Affiliates arising out of or in connection with the termination of the Collaboration Agreement pursuant to this Agreement.

9.5.
All payments to be made under this Article 9 will be made without deduction or withholding for or on account of any present or future taxation unless Amgen is required by law to deduct or withhold such withholding tax. GSK shall be solely responsible for any tax liabilities relating to amounts received under this agreement, with the exception of any required withholding in Puerto Rico arising from the inclusion of Amgen Manufacturing, Limited as a party to this Agreement, which withholding shall be borne by Amgen and Amgen shall increase the relevant payment from Amgen Manufacturing, Limited to GSK by the amount of any such required withholding. GSK and Amgen will cooperate with respect to all documentation required by any tax authority or which may reasonably be requested by Amgen to secure a reduction in the rate of applicable withholding taxes or to permit Amgen to obtain a repayment of or credit for all withholding tax withheld for payments due to GSK.

9.6.
All payments within this Agreement are exclusive of Sales Tax or Value Added Tax. If any Sales Tax or Value Added Tax is properly chargeable in respect of any supply made under this Agreement, then the Sales Tax or Value Added Tax shall be charged in addition to the fees charged under this Agreement.

9.7.
For the avoidance of doubt, the Collaboration Profit (Loss) under the Collaboration Agreement shall not apply as of the Effective Date.

9.8.
Miscellaneous. Each Party shall bear all costs incurred by it or any of its Affiliates in connection with the preparation and negotiation of, and the entry into, this Agreement.

10.
EMPLOYMENT RELATED MATTERS

10.1.
During the period commencing on the Effective Date and ending upon the end of the Transition in each country of the Transition Territory, Amgen and its Affiliates shall not solicit any representative employed by GSK that is Detailing Ivory in compliance with the Transition Plan to leave the employment of GSK and accept employment or work with Amgen or its Affiliates unless such employment or work will commence after the Transition Date in respect of the country where the representative in question is employed. Notwithstanding the foregoing, nothing herein shall restrict or preclude the right of Amgen or its Affiliates to make generalized searches for employees by way of a general solicitation for employment placed in a trade journal, newspaper or website; provided, that if Amgen or its Affiliates determines that it will search for employees to fill general sales representative functions or other roles in support of Ivory during the Term of this Agreement, then Amgen or its Affiliates will use reasonable efforts to first consult with GSK to determine whether GSK has employees that are or have been Detailing Ivory or who have otherwise supported Ivory and who may be eligible and willing to apply for such general sales representative function or other role at Amgen or the applicable Amgen Affiliate. If such eligible GSK employees exist, then Amgen or its Affiliates shall use reasonable efforts to discuss such general sales representative function or other role with each such eligible employee and to consider employing him or her for such position in good faith.

10.2.
GSK will defend, indemnify, and hold harmless Amgen Indemnitees at GSK’s cost and expense, from and against all Losses (including all Employment Liabilities, where applicable) incurred or suffered by the Amgen Indemnitees arising from or in connection with:

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10.2.1. the transfer or purported transfer of employment to Amgen or any of its Affiliates or any replacement contractor of Amgen or its Affiliates, of any person currently or previously employed or engaged by GSK or its Affiliates or any of their contractors or agents who was involved in the Designated GSK Activities (together, “GSK Staff”), howsoever arising including by operation of Applicable Laws in the Transition Territory; and

10.2.2. the termination by GSK or its Affiliates or any of its or their contractors or agents of the employment of any GSK Staff; and

10.2.3. any failure by GSK or its Affiliates, or any of its or their contractors or agents, to: (i) discharge in full any obligation to inform or consult GSK Staff about the transactions contemplated by this Agreement or its termination, or the termination of the Collaboration Agreement; or (ii) comply with its obligations in respect of GSK Staff in accordance with Applicable Laws,

provided that GSK shall not be required to defend, indemnify, and hold harmless Amgen Indemnitees at GSK’s cost and expense from and against Losses that are incurred or suffered directly as a result of acts or omissions of Amgen or its Affiliates.

11.
RELATIONSHIP WITH EXPANSION AGREEMENT

11.1.
Accession to EU. If a country falls outside the scope of the Expansion Agreement as a result of its having acceded to the European Union after the Effective Date, the following provisions will apply:

11.1.1.
Amgen Inc and Amgen and their respective Affiliates will have the sole right to commercialize Ivory in the country upon such country acceding to the European Union; and

11.1.2.
the Expansion Agreement shall be deemed to terminate in respect of that country, and the provisions of Sections 12.9 and 12.10 of the Expansion Agreement shall apply accordingly; in particular, GSK will undertake Commercially Reasonable Efforts to effect a smooth and orderly transition of all commercial activities and responsibilities of GSK under the Expansion Agreement in respect of the country to Amgen or its Affiliate in such country, as soon as reasonably possible, to enable Amgen or its Affiliate in such country to continue the promotion and commercialization of Ivory in the Expansion Scope after such termination.

11.2.
Sales into Transition Territory. The Parties acknowledge that, under the Expansion Agreement, GSK is granted the sole responsibility for the conduct of all commercialisation activities (including selling and distributing) within the Expansion Scope (as defined therein) and is required to take reasonable steps (including as may be reasonably requested by Amgen) to ensure that Ivory sold by it is not used outside the Expansion Territory (as defined therein).

12.
INDEMNIFICATION AND INSURANCE

12.1.
The provisions of the Collaboration Agreement set out in Schedule 2.2 that relate to ‘Indemnity by GSK’ (Section 13.1), ‘Indemnity by Amgen’ (Section 13.2), ‘Claim for Indemnification’ (Section 13.4), ‘Defense of Third-Party Claims’ (Section 13.5) and ‘Insurance’ (Section 13.6) shall survive termination of the Collaboration Agreement and are incorporated by reference herein.

13.
TERM AND TERMINATION

13.1.
Term. This Agreement will become effective on the Effective Date and (without prejudice to Section 15.5) will expire on a country-by-country basis, in each case with effect on the close of business on the date on which all Material Activities and all Other Activities have been completed (as agreed in writing

17



by the Transition Managers) for that country (the “Term”). If Amgen, in good faith, reasonably believes that the Material Activities with respect to all countries in the Transition Territory have not been materially completed on or before December 31, 2014, then Amgen shall deliver written notice to GSK and shall specify in such written notice the particular services that remain incomplete and/or the particular documents, information and data that remain not delivered. Such notice must be received by GSK not later than fifteen (15) Business Days prior to December 31, 2014 (the “Notice Date”). If GSK does not receive such a written notice by the Notice Date, then the Transition Date shall be deemed to have occurred and the Material Activities shall be deemed completed. If GSK receives such a written notice by the Notice Date and GSK disagrees with Amgen’s assertion that the Material Activities have not been materially completed, either GSK or Amgen may refer such disagreement for resolution in accordance with Section 15.1.

13.2.
Consequences of Expiration. Upon the expiration of this Agreement in respect of a country within the Transition Territory, the following will apply:

13.2.1.
Expiration of this Agreement for any reason will not release any Party from any liability (including any payment obligation) that, at the time of such expiration, has already accrued to another Party or that is attributable to activities prior to such termination.

13.2.2.
Upon expiration of this Agreement in respect of a country: (i) GSK’s right to Detail Ivory in that country will terminate; (ii) all licenses to GSK in respect of that country hereunder will terminate; and (iii) GSK will immediately cease all of its promotional and marketing activities for Ivory in that country and discontinue all use of Amgen Housemarks and Product Trademarks in that country.

13.2.3.
Product Data transferred to Amgen from GSK hereunder and/or that was made by or on behalf of GSK that solely pertain to Ivory (or, where such Product Data pertain to Ivory as well as another product, those portions that specifically pertain to Ivory) will be deemed Confidential Information of Amgen, and not Confidential Information of GSK (and will not be subject to the exclusion under Section 11.1.1 or 11.1.4 of the Collaboration Agreement incorporated by reference herein pursuant to Section 8.1 of this Agreement), and Amgen will have the unrestricted right to use and disclose all such Product Data following termination of this Agreement. In addition, GSK will destroy all relevant records and materials in GSK’s possession or control containing Confidential Information of Amgen (provided that GSK may keep: (i) copies of such records as may be required for GSK to comply with Applicable Laws and national or international pharmaceutical industry codes of practice; and (ii) one copy of such Confidential Information of Amgen for archival purposes only; provided that, in each case, such copies are Segregated from any Distracting Program).

13.2.4.
GSK will destroy (and certify such destruction to Amgen), all Promotional Materials, sales training materials and any other documents, or materials primarily intended for use in commercialization of Ivory in the Transition Territory except copies required for GSK to comply with Applicable Laws and national or international pharmaceutical industry codes of practice.

13.2.5.
The following provisions of this Agreement will survive expiration of this Agreement for any reason: Article 1 (Definitions), Section 7.3 (Right to Use GSK Housemarks), Section 10.2, Section 13.2 and Article 15 (Miscellaneous), as well as all provisions of the Collaboration Agreement set out in Schedule 2.2 that are indicated as surviving beyond the Term. Except as otherwise provided in this Agreement, all rights and obligations of the Parties under this Agreement in respect of a country will terminate upon termination of this Agreement in respect of that country.

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14.
REPRESENTATIONS AND WARRANTIES

14.1.
General. The provisions of the Collaboration Agreement set out in and amended by Schedule 2.2 that relate to ‘Mutual Representations and Warranties’ (Section 12.1), ‘Amgen Representations and Warranties’ (Section 12.2), ‘GSK Representations and Warranties’ (Section 12.4, ‘Disclaimer of Warranties’ (Section 12.6) and ‘Representations and Warranties – Covenants’ (Section 12.8) shall survive termination of the Collaboration Agreement and are incorporated by reference herein.

14.2.
NOTWITHSTANDING ANY OTHER PROVISION CONTAINED HEREIN, OTHER THAN TO THE EXTENT RESULTING FROM A PARTY’S BREACH OF ARTICLE 8 OF THE COLLABORATION AGREEMENT (DISTRACTING PRODUCTS) AS INCORPORATED BY REFERENCE PURSUANT TO ARTICLE 6 OR SECTION 11.1 OF THE COLLABORATION AGREEMENT (CONFIDENTIALITY; EXCEPTIONS) AS INCORPORATED BY REFERENCE PURSUANT TO SECTION 8.1, IN NO EVENT WILL GSK, ON THE ONE HAND, OR AMGEN OR AMGEN INC. ON THE OTHER HAND, BE LIABLE TO THE OTHER OR ANY OF THE OTHER’S AFFILIATES FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED OR INCURRED BY SUCH OTHER PARTY OR ITS AFFILIATES IN CONNECTION WITH A BREACH OR ALLEGED BREACH OF THIS AGREEMENT. THE FOREGOING SENTENCE WILL NOT LIMIT THE OBLIGATIONS OF ANY PARTY TO INDEMNIFY ANY OTHER PARTY PURSUANT TO SECTION 10.2 OR FROM AND AGAINST THIRD-PARTY CLAIMS UNDER SECTION 13.1 OF THE COLLABORATION AGREEMENT (INDEMNITY BY GSK) AS INCORPORATED BY REFERENCE PURSUANT TO ARTICLE 12 OR UNDER SECTION 13.2 OF THE COLLABORATION AGREEMENT (INDEMNITY BY AMGEN) AS INCORPORATED BY REFERENCE PURSUANT TO ARTICLE 12.

15.
MISCELLANEOUS

15.1.
Dispute Resolution. In the event of any controversy or dispute arising out of or relating to any provision of this Agreement, the construction, validity or breach thereof, the Parties will try to settle the same amicably between themselves. If the Parties fail to settle such matter within thirty (30) days of it having arisen, such matter will be exclusively and finally resolved by binding arbitration under the Rules of Arbitration of the International Chamber of Commerce (the “Rules”) before a panel of three (3) arbitrators selected in accordance with the Rules. The place of the arbitration will be Zurich, Switzerland and the language of the arbitration will be English. In the event of a dispute involving the alleged breach of this Agreement, the Parties shall toll the activity that is the subject of the dispute until such time as the dispute is resolved in accordance with this Section 15.1. Any disputed performance or suspended performance pending the resolution of a dispute involving the alleged breach of this Agreement that the arbitration panel determines to be required to be performed by a Party must be completed within a reasonable time period following the final decision of the arbitration panel. The final arbitration award will be final and binding upon the Parties and may be entered in any court of competent jurisdiction for enforcement. The arbitrators will have the power to grant monetary damages as well as injunctive or other specific relief. Notwithstanding the foregoing, each Party will have the right to seek, without establishment of the arbitral tribunal, injunctive or other provisional relief from a court of competent jurisdiction that may be necessary to avoid irreparable harm or preserve the subject matter of a dispute. Each Party will bear its own costs and expenses and attorneys’ fees, and the Party that does not prevail in the arbitration proceeding will pay the arbitrators’ fees and any administrative fees of arbitration.

15.2.
Choice of Law. This Agreement will be governed by, and enforced and construed in accordance with, the laws of the State of New York, USA, without regard to its conflicts of law provisions. The United Nations Convention for the International Sale of Goods will not apply to the transactions contemplated

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herein.

15.3.
Press Releases. Each of GSK and Amgen Inc will have the right to issue press releases and disclosures in regard to the terms of this Agreement only with the prior written consent of the other Party, such consent not to be unreasonably withheld (or as required to comply with Applicable Laws). For any such proposed press release or disclosure, the disclosing Party will provide ten (10) Business Days’ notice to the other Party and will reasonably consider the other Party’s comments that are provided within five (5) Business Days after such notice, or such shorter notice and comment periods as are reasonably required under the circumstances but not less than two (2) Business Days.

15.4.
Force Majeure. No Party will be liable for delay or failure in the performance of any of its obligations hereunder (other than the payment of money) to the extent such delay or failure is due to a Force Majeure; provided, that the affected Party promptly notifies the other Parties in writing (and continues to provide monthly status updates to the other Parties for the duration of the effect); and provided further that the affected Party uses its Commercially Reasonable Efforts to avoid or remove such causes of non- performance and to mitigate the effect of such occurrence, and will continue performance with reasonable dispatch whenever such causes are removed.

15.5.
Other Miscellaneous Provisions. The ‘Miscellaneous’ provisions of the Collaboration Agreement set out in and amended by Schedule 2.2 that relate to ‘Affiliates’ (Section 16.1), ‘Assignment’ (Section 16.3), ‘Compliance with Applicable Law’ (Section 16.5), ‘Construction’ (Section 16.6), ‘Counterparts’ (Section 16.7), ‘Currency’ (Section 16.8), ‘Entire Agreement’ (Section 16.9), ‘Further Assurances’ (Section 16.11), ‘Headings’ (Section 16.12), ‘No Set-Off’ (Section 16.13), ‘Notices’ (Section 16.14), ‘Relationship of the Parties’ (Section 16.15), ‘Severability’ (Section 16.16), ‘Third-Party Beneficiaries’ (Section 16.18) and ‘Waivers and Modifications’ (Section 16.19) shall survive termination of the Collaboration Agreement and are incorporated by reference herein.


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IN WITNESS WHEREOF, the Parties have executed this Agreement on the date and year first above written.



GLAXO GROUP LIMITED

By:
/s/ Paul Williamson
Name:
Paul Williamson
Title:
 

AMGEN MANUFACTURING LIMITED
 
AMGEN INC.
By:
/s/ Carsten Thiel
 
By:
/s/ Carsten Thiel
Name:
Dr. Carsten Thiel
 
Name:
Dr. Carsten Thiel
Title:
Regional General Manager
 
Title:
Regional General Manager
 
VP, Europe
 
 
VP, Europe






SCHEDULE 2.2

Surviving Provisions of the Collaboration Agreement

The following provisions of the Collaboration Agreement shall survive termination thereof, for the period(s) and with the qualifications indicated below, and are hereby incorporated into this Agreement as if fully set out herein.For the avoidance of doubt, the provisions set out below are applicable to each of Amgen Inc., Amgen and GSK:

PROVISION OF
COLLABORATION
AGREEMENT
RELEVANT
PROVISION OF THIS
AGREEMENT
SURVIVAL PERIOD
QUALIFICATIONS / COMMENTS
Article 1 - Definitions
Sections 1.3 and
13.2.5
Indefinite term
Article 1 of the Collaboration Agreement
shall survive termination of the Collaboration Agreement and is incorporated by reference into this Agreement to the extent required in order to give effect to the other surviving provisions of the Collaboration Agreement.
Article 2 - Scope and
Governance
 
 
 
Section 2.13.1 - Meetings
Section 5.2.3
Term of this
Agreement
Provided that:

(i) the reference to “six (6) times per year” shall be replaced by a reference to “once per calendar month”; and
(ii) references to the “JBT” shall be deemed to be references to the “Transition Managers”
(iii) the last sentence of Section 2.13.1 that states “At the request of the JBT, each Country Team will attend international brand strategy and/or communications summits” shall be deleted.
Section 2.13.2 -
Reporting
Section 5.2.3
Term of this
Agreement
 
Section 2.13.3 - Decision
Making
Section 5.2.3
Term of this
Agreement
Provided that references to the “JSC” shall
be deemed to be references to the
“Transition Managers”

For the avoidance of doubt, any issues that cannot be finally decided by the Transition Managers shall be handled in accordance


22



PROVISION OF
COLLABORATION
AGREEMENT
RELEVANT
PROVISION OF THIS
AGREEMENT
SURVIVAL PERIOD
QUALIFICATIONS / COMMENTS
 
 
 
with Section 5.5 of this Agreement and not
Section 2.13.3 unless the dispute involves above-country issues relating to Ivory.
Section 2.14 - Patent
Coordinators
Section 5.3.1
Term of this
Agreement
Provided that references to the “JSC” shall
be deemed to be references to the
“Transition Managers”
Section 2.17 - Internal
Governance
Section 5.7
Term of this
Agreement
 
Article 3 - Collaboration Activities
- Allocation and
Reporting
 
 
 
Section 3.7 - All Sales by
Amgen
Section 4.4
Term of this
Agreement
For the avoidance of doubt, GSK, its
Affiliates or their respective agents or employees are not, during the Term or thereafter, authorized to sell Ivory, except as otherwise stated in the Expansion Agreement
Section 3.8 - Training
Sections 4.4,
7.1.1, 13.2.5
Term of this
Agreement except for the last sentence of section 3.8 of the Collaboration Agreement which shall be Indefinite
References to “JBT” shall be replaced with
“Country Teams”.
Section 3.9 - Information
concerning Ivory

-Section 3.9.1 -Public Statements
-Section 3.9.2 -
Ownership
Sections 7.1.1 and
13.2.5
Section 3.9.1 -
Term of this
Agreement


Section 3.9.2 - Indefinite term
 
Section 3.10 -
Promotional Materials
Sections 4.3, 7.1.1
and 13.2.5
Term of this
Agreement, except for the last sentence
of Section 3.10 of
the Collaboration
Agreement which will apply for an
For the avoidance of doubt, “Promotional
Materials” include all training materials relating to Ivory.



The allocation of responsibility for the matters covered by this provision shall apply to the extent not otherwise allocated


23



PROVISION OF
COLLABORATION
AGREEMENT
RELEVANT
PROVISION OF THIS
AGREEMENT
SURVIVAL PERIOD
QUALIFICATIONS / COMMENTS
 
 
indefinite term
by the terms of the Transition Plan or this
Agreement.



For the avoidance of doubt, the Parties do not expect the generation or development of any new Promotional Materials during the Term of this Agreement, except to communicate changes to Ivory’s label as required by Regulatory Authorities, and any such new materials shall not include GSK Housemarks.
Section 3.11.1 -
Reporting
Section 4.3
Term of this
Agreement
Section 3.11.1(i) of the Collaboration
Agreement shall be incorporated by reference into this Agreement to the extent
that it requires GSK, but not Amgen, to
provide Detail Reports, and such Detail Reports will be submitted to the Country Teams. References to the “JSC” or “JBT” shall be deemed to be references to the “Transition Managers”
Section 3.12 - Medical
Inquiries and Product
Inquiries
Section 4.3
Term of this
Agreement
Section 3.12 of the Collaboration
Agreement shall be incorporated by reference into this Agreement in respect of each country until the Transition in respect of each such country is effected, and to the extent that the responsibility for the matters covered by such section is not otherwise regulated by the terms of the Transition Plan or this Agreement
Section 3.13 - Samples
Section 4.3
Term of this
Agreement
Section 3.13 of the Collaboration
Agreement shall be incorporated by reference into this Agreement in respect of each country until the Transition in respect of each such country is effected, and to the extent that the responsibility for the matters covered by such section is not otherwise regulated by the terms of the Transition Plan or this Agreement. References to the “JSC” or “JBT” shall be deemed to be references to the “Transition Managers”. For clarity, the reference to “this Agreement” in the last sentence of Section


24



PROVISION OF
COLLABORATION
AGREEMENT
RELEVANT
PROVISION OF THIS
AGREEMENT
SURVIVAL PERIOD
QUALIFICATIONS / COMMENTS
 
 
 
3.13 shall refer to this Termination and
Transition Agreement and not the
Collaboration Agreement.
Section 3.14 - Non-
Commercial Activities
Section 4.4
Term of this
Agreement
Only the first and second sentences of
Section 3.14 of the Collaboration
Agreement shall be incorporated by reference into this Agreement; provided that the reference to “JDC” shall be “Transition Managers”
Article 4 - Collaboration Activities
- Performance
Standards
 
 
 
Section 4.2 - Diligence
and Performance
Standards
Section 4.3
Term of this
Agreement
Section 4.2 of the Collaboration Agreement
shall be incorporated by reference into this Agreement in respect of each country of the Transition Territory until the Transition in respect of each such country is effected, provided that references to the Collaboration Agreement, the Brand Plan and applicable Country Plans shall be replaced by references to this Agreement, the Transition Plan, and (to the extent not superseded by the foregoing) the Brand Plan for Ivory that has been agreed between the Parties for 2014
Section 4.4 - Violation of
Laws
Section 4.3
Term of this
Agreement
Provided that references to the “JSC” shall
be deemed to be references to the
“Transition Managers”
Section 4.5 - Use of
Affiliates and Third Party
Contractors
Section 4.3
Term of this
Agreement
Only the first sentence and the last sentence
(as it relates to GSK) of Section 4.5 of the
Collaboration Agreement shall be incorporated by reference in this Agreement
Section 4.6 - Affiliates
Section 4.3
Term of this
Agreement
 
Section 4.7 -
Management of Personnel
Section 4.3
Term of this
Agreement
 


25



PROVISION OF
COLLABORATION
AGREEMENT
RELEVANT
PROVISION OF THIS
AGREEMENT
SURVIVAL PERIOD
QUALIFICATIONS / COMMENTS
Article 7 - Payments
Section 9.1.2
Term of this
Agreement
Article 7 of the Collaboration Agreement
shall be incorporated with the exception of
Sections 7.1, 7.4, 7.6, 7.7 and 7.9
Article 8 - Distracting
Products
Sections 6.1 and
13.2.5
For one (1) year
following the
Effective Date of this Agreement
Article 8 other than Sections 8.1.2 and 8.6
shall be incorporated by reference into this
Agreement
Article 9 - Intellectual
Property
 
 
 
Section 9.1 - Invention
Ownership
Sections 7.1.1 and
13.2.5
Indefinite term
For the avoidance of doubt, the Parties
agree that there are no Joint Inventions as of the Effective Date.
Section 9.2 - Copyright
Ownership, Certain
Confidential Information
Sections 7.1.1 and
13.2.5
Indefinite term,
except that the provisions
regarding
Confidential
Information will be subject to the term applicable to Confidential Information.
 
Section 9.3 - Joint
Ownership
Sections 7.1.1 and
13.2.5
Indefinite term
 
Section 9.4 - License
Grant by Amgen
Section 7.1.1
Term of this
Agreement
The license shall also permit GSK to
conduct all activities under the Transition
Plan.
Section 9.5 - License
Grant by GSK
Sections 7.1.1 and
13.2.5
Indefinite term
Provided that references to “Term” shall
mean “the term of the Collaboration Agreement and this Agreement” and the reference to “hereunder” shall mean “under the Collaboration Agreement and this Agreement”
Section 9.6 - Prosecution
and Maintenance
Section 7.1.1
Term of this
Agreement
Only the first sentence of Section 9.6 of the
Collaboration Agreement is incorporated by reference into this Agreement.
Section 9.7 - Defense and
Settlement of Third Party
Section 7.1.1
Indefinite term
With respect to the defense of the Parties’
activities that took place during the term of


26



PROVISION OF
COLLABORATION
AGREEMENT
RELEVANT
PROVISION OF THIS
AGREEMENT
SURVIVAL PERIOD
QUALIFICATIONS / COMMENTS
Claims of Infringement
 
 
the Collaboration Agreement and this
Agreement.
Section 9.8 -
Enforcement
Sections 7.1.1 and
13.2.5
Indefinite term with respect to the first two, and the last, sentences of Section 9.8.
Section 9.8 of the Collaboration Agreement
is incorporated by reference into this
Agreement (with respect to enforcement against activities that took place during the
term of the Collaboration Agreement and of
this Agreement) but excluding the words “but included…” in the last sentence of Section 9.8)
 
 
The remainder of Section 9.8 as modified herein shall survive for the Term of the Agreement.
 
Section 9.9 - Patent Term
Extensions
Sections 7.1.1 and
13.2.5
Indefinite term
Section 9.9 of the Collaboration Agreement
is incorporated by reference with respect to periods during the term of the Collaboration
Agreement and of this Agreement
Section 9.10 - Employee
Agreements
Section 7.1.1
Term of this
Agreement
 
Section 9.11 -
Trademarks
Sections 7.1.1 and
13.2.5
 
 
Section 9.11.1 Title




















 
Indefinite term for the first and second sentence of Section
9.11.1 of the
Collaboration
Agreement



Term of this Agreement for the third sentence of Section 9.11.1 of the Collaboration Agreement




 
Section 9.11.2 Required
Use and Compliance
 
Term of this
Section 9.11.2.1 is incorporated into this

27



PROVISION OF
COLLABORATION
AGREEMENT
RELEVANT
PROVISION OF THIS
AGREEMENT
SURVIVAL PERIOD
QUALIFICATIONS / COMMENTS
 
 
Agreement
Agreement to the extent that the Transition
Plan or this Agreement do not provide otherwise

Section 9.11.3 Licences:
-Section 9.11.3.1
Licenses to GSK
 
Term of this Agreement for Section 9.11.3.1 of the Collaboration Agreement
Section 9.11.3.1 of the Collaboration Agreement is incorporated by reference into this Agreement to the extent that the Transition Plan or this Agreement do not provide otherwise
-Section 9.11.3.2 (as amended) License To Amgen

 

For the Term of this Agreement plus the sell-off period of either six (6) months or twelve (12) months after termination of the Collaboration Agreement as permitted under Section 9.11.3.2

Section 9.11.3.2 of the Collaboration Agreement is incorporated by reference to the extent that the Transition Plan or this Agreement do not provide otherwise. Terms shall also apply, mutatis mutandis, to depletion by Amgen of inventory of Ivory.
Section 9.11.4 Respect of
Trademarks
 
Term of this
Agreement
 
Section 9.11.5
Infringement
 
Term of this
Agreement
 
Article 10 - Regulatory
and Safety
 
 
 
Section 10.1.1 -
Regulatory
Communication and
Filing
Section 8.1
Term of this
Agreement
Section 10.1.1 is incorporated by reference
into this Agreement except that the last sentence shall only apply if reasonable to
effect the provisions of Article 8 of this
Agreement and the conduct of the
Transition Plan.

28




PROVISION OF
COLLABORATION
AGREEMENT
RELEVANT
PROVISION OF THIS
AGREEMENT
SURVIVAL PERIOD
QUALIFICATIONS / COMMENTS
Section 10.1.3 - GSK
Obligations
Section 8.1
Term of this
Agreement
 
Section 10.1.4 - Labeling
and Packaging Materials
Section 8.1
Term of this
Agreement
Section 10.1.4 is incorporated by reference
into this Agreement except for the proviso in the first sentence. For clarity, Amgen
shall not have the right to use the GSK Housemarks on any labeling, packaging or
package inserts that are created after the Effective Date unless otherwise expressly provided in this Agreement.
Section 10.1.5 -
Regulatory and Safety
Information
Section 8.1
Term of this
Agreement
Section 10.5 is incorporated by reference
into this Agreement except for the last sentence.
Section 10.2 (as amended)
- Brand Security and
Anti-Counterfeiting
Section 8.1
Term of this
Agreement
 
Section 10.3 - Product
Technical Complaints; Recalls; Returns
Sections 8.1
Term of this
Agreement
 
Article 11 - Confidentiality,
Publications and Press
Releases
 
 
 
Section 11.1 -
Confidentiality
Sections 8.1
In respect of
information furnished under the
Collaboration
Agreement: until the date falling five (5) years after termination of the Collaboration Agreement.


In respect of information furnished under this Agreement: until the date falling five (5) years after termination of this
Section 11.1 of the Collaboration
Agreement, as incorporated by reference into this Agreement, shall apply in relation
to information furnished under the
Collaboration Agreement and this
Agreement


29



PROVISION OF
COLLABORATION
AGREEMENT
RELEVANT
PROVISION OF THIS
AGREEMENT
SURVIVAL PERIOD
QUALIFICATIONS / COMMENTS
 
 
Agreement.
 
Section 11.2 - Authorized
Disclosure
Sections 8.1 and
13.2.5
Indefinite term
 
Section 11.3 -
Confidential Treatment of
Terms and Conditions
Sections 8.1 and
13.2.5
Indefinite term
 
Section 11.6 -
Publications and Program
Information
Section 8.1
Term of this
Agreement
Provided that references to the “JDC/JBT”
shall be deemed to be references to the
“Transition Managers”
Section 11.7 - Attorney-
Client Privilege
Sections 8.1 and
13.2.5
Indefinite term
Provided that references to “Agreement”
shall be deemed references to the
Collaboration Agreement and this
Agreement
Section 11.8 - Injunctive
Relief
Sections 8.1 and
13.2.5
Indefinite term
 


30



PROVISION OF
COLLABORATION
AGREEMENT
RELEVANT
PROVISION OF THIS
AGREEMENT
SURVIVAL PERIOD
QUALIFICATIONS / COMMENTS
Article 12 - Representations and Warranties



Section 12.1 - Mutual Representations and Warranties

Section 12.2 - Amgen Representations and Warranties

Section 12.4 - GSK Representations and Warranties

Section 12.6 - Disclaimer of Warranties

Section 12.8 - Covenants
Section 14.1 and
13.2.5
Term of this
Agreement, except for Section 12.6 which shall survive indefinitely
The Sections of Article 12 of the
Collaboration Agreement listed in the first column are incorporated by reference into this Agreement, provided that the reference to Article 12 in Section 12.6 of the Collaboration Agreement shall be deemed to be a reference to Article 14 of this Agreement
Article 13 -
Indemnification and
Insurance



Section 13.1 - Indemnity by GSK

Section 13.2 - Indemnity by Amgen

Section 13.4 - Claim for
Indemnification

Section 13.5 - Defense of
Third Party Claims






Section 13.6 - Insurance
Section 12.1 and
13.2.5
Indefinite term with respect to Sections 13.1, 13.2, 13.4 and 13.5.

Term of this Agreement with respect to Section
13.6.
The Sections of Article 13 of the
Collaboration Agreement listed in the first column are incorporated by reference into this Agreement, provided that any references to Articles 12 and 13 in those provisions shall be deemed to be a reference to Article 14 and 12 of this Agreement respectively.








All parentheticals in Section 13.5 stating “(subject to Section 6.1.1.4 and 6.1.2.11, to the extent applicable)” are deleted.
Article 16 -
 
 
 



31



PROVISION OF
COLLABORATION
AGREEMENT
RELEVANT
PROVISION OF THIS
AGREEMENT
SURVIVAL PERIOD
QUALIFICATIONS / COMMENTS
Miscellaneous
 
 
 
Section 16.1 - Affiliates
Section 15.5
Term of this
Agreement
 
Section 16.3 -
Assignment
Sections 15.5 and
13.2.5
Indefinite term
 
Section 16.5 -
Compliance with
Applicable Law
Section 15.5
Term of this
Agreement
 
Section 16.6 -
Construction
Sections 15.5 and
13.2.5
Indefinite term
Excluding limbs (i) and (vi) of the fifth
sentence
Section 16.7 -
Counterparts
Section 15.5
Term of this
Agreement
 
Section 16.8 - Currency
Section 15.5
Term of this
Agreement
 
Section 16.9 - Entire
Agreement
Sections 15.5 and
13.2.5
Indefinite term
 
Section 16.11 - Further
Assurances
Section 15.5
Term of this
Agreement
 
Section 16.12 - Headings
Section 15.5
Term of this
Agreement
 
Section 16.13 - No Set-
Off
Section 15.5
Term of the
Agreement
Provided the exceptions stated therein for
True-Up shall not be incorporated by reference into this Agreement
Section 16.14 - Notices
Sections 15.5 and
13.2.5
Indefinite term
Notices to Amgen Manufacturing Limited
shall be sent to the address set out in
Section 9.3 of this Agreement.
Section 16.15 -
Relationship of the Parties
Section 15.5
Term of this
Agreement
 
Section 16.16 -
Severability
Sections 15.5 and
13.2.5
Indefinite term
 
Section 16.18 - Third
Party Beneficiaries
Sections 15.5 and
13.2.5
Indefinite term
Provided that the exception to Section
16.18 of the Collaboration Agreement shall be deemed to refer to Article 12 of this Agreement

32




PROVISION OF
COLLABORATION
AGREEMENT
RELEVANT
PROVISION OF THIS
AGREEMENT
SURVIVAL PERIOD
QUALIFICATIONS / COMMENTS
Section 16.19 - Waivers
and Modifications
Sections 15.5 and
13.2.5
Indefinite term
 



33





SCHEDULE 3.2

Anticipated Transition Dates






MARKET
ANTICIPATED
TRANSITION DATE
Austria
end June
Belgium (& Lux)
end June
Bulgaria
end June
Croatia
end May
Cyprus
end June
Czech Republic
end June
Denmark
end April
Estonia
end June
Finland
end June
France
end September
Germany
end June
Greece
end June
Hungary
end June
Ireland
end August
Italy
end May
Latvia
end June
Lithuania
end June
Malta
end May
Netherlands
end June
Norway
end May
Poland
end May
Romania
end May
Slovakia
end June
Slovenia
end June
Spain
end June
Sweden
end June
Switzerland
end June
United Kingdom
end April
Mexico
end May
Russia
end June


34





SCHEDULE 3.4(a)

Transition Plan



Please see attached.


35



Schedule 3.4(a) of the Termination and Transition
Agreement:Transition Plan


Ref.
Category
Transition Activity Area
Description of activities
Date of Completion of Transition
Parties Involved
Status
Written completion determined by Country Teams (GSK/Amgen) and confirmed by Transition Managers
Comment
1
Material
Activity
Transfer of Product
Data
GSK will provide title, first name, last name, work address, phone number of Physician and
nurse/payer (where applicable and available) who are Prolia specific targets (A,B,C) subject to data privacy law(s) applicable in every country where data is to be transferred. If to make this transfer, applicable data privacy law requires the consent of the Physicians or nurse/payer or notification to/approval of the local data privacy authority, GSK will: (i) approach the Physicians or nurse/payer by way of a written request to obtain consent or notification (as applicable); and/or (ii) seek approval of the relevant authorities. Where legally permissible, GSK will phrase the consent to Physicians or nurse/payer as an “opt out”, i.e. the individual must affirmatively choose not to provide consent within the minimum timeframe permitted by applicable law and silence within that timeframe will be deemed consent. Where “opt out” is not legally permissible, GSK will send a written reminder to any Physicians or nurse/payer who has not yet responded in writing to the initial written request for consent on the date falling 7-8 Business Days thereafter. Where the legal requirements cannot be met and/or (where “opt-out” is not legally permissible) if no response from individuals is received within
14 calendar days of the date on which the reminder was sent, there will be no further request to Physicians or nurse/payer. GSK will have fulfilled all relevant requirements based on this clause. Notwithstanding the foregoing, GSK will transfer all data for Physicians or nurse/payer where consent is received (or deemed to be received, where “opt-out” was used) on or before December 31, 2014.
[Per the agreed
Transition Date]
GSK
 
 
 
2
Material
Activity
Transfer of Product
Data
GSK to provide to Amgen the name, last name for customer targets by classification (e.g.
A,B,C) for the country subject to data privacy law(s) applicable in every country where data is to be transferred. If to make this transfer, applicable data privacy law requires the consent of the Physicians or nurse/payer or notification to/approval of the local data privacy authority, GSK will: (i) approach the Physicians or nurse/payer by way of a written request to obtain consent or notification (as applicable); and/or (ii) seek approval of the relevant authorities. Where legally permissible, GSK will phrase the consent to Physicians or nurse/payer as an “opt out”, i.e. the individual must affirmatively choose not to provide consent within the minimum timeframe permitted by applicable law and silence within that timeframe will be deemed consent. Where “opt out” is not legally permissible, GSK will send a written reminder to any Physicians or nurse/payer who has not yet responded in writing to the initial written request for consent on the date falling 7-8 Business Days thereafter. Where the legal requirements cannot be met and/or (where “opt-out” is not legally permissible) if no response from individuals is received within 14 calendar days of the date on which the reminder was sent, there will be no further request to Physicians or nurse/payer. GSK will have fulfilled all relevant requirements based on this clause. Notwithstanding the foregoing, GSK will transfer all data for Physicians or nurse/payer where consent is received (or deemed to be received, where “opt-out” was used) on or before December 31, 2014.
[Per the agreed
Transition Date]
GSK
 
 
 
3
Material
Activity
Transfer of Product
Data
GSK to provide all details (communiques/emails), at GSK HQ and country level, concerning budget, billing or other costs associated to Detailing, marketing, sales and medical led activities (outside Q1 normal collaboration reconciliation billing process, during transition and future committed). This Includes any committed projects eg: physician meetings, congresses, external meetings, travel, in surgery or out of surgery.
[Per the agreed
Transition Date]
GSK
 
 
 

36





4
Material
Activity
Transfer of Product
Data
GSK to handover details regarding Prolia patient assistance programs at country level (if applicable) and if requested by Amgen. In the event 3rd party data is required to be transferred, Amgen will contact the 3rd party provider and arrange transfer at its own cost and GSK will use reasonable efforts to contractually ensure that the 3rd party provider is allowed to transfer such data to Amgen and, if contractual rights are transferred from GSK to Amgen, Amgen will cover any additional costs with regards to transfer of contractual rights.
[Per the agreed
Transition Date]
GSK
 
 
 
5
Material
Activity
Transfer of Product
Data
For Countries where Amgen Affiliates have NO ZINC access, GSK to provide the list of approved/active Prolia materials stored in ZINC and Amgen has a right to request an electronic copy.
For Countries where Amgen Affiliates have ZINC access: Amgen will download all ZINC Prolia materials. GSK to provide list of materials for Prolia not stored in ZINC, where applicable, (Examples of such materials are tradeshow displays, videos and digital media) and Amgen has the right to request a copy of materials not in possession of Amgen.
[Per the agreed
Transition Date]
GSK and Amgen
 
 
 
6
Material
Activity
Transfer of Product
Data
GSK to provide list of all Regulatory Filings re Prolia - where such activities were jointly led
by GSK and/or Amgen or solely by GSK in Croatia - in possession GSK country team; Amgen to request data related to Regulatory Filings re Prolia within 5 working days upon receipt of the list, of no request by Amgen made within 5 working days GSK obligation herein is considered fulfilled.
[Per the agreed
Transition Date]
GSK and Amgen
 
 
 
7
Material
Activity
Transfer of Product
Data
GSK to transfer customer Product Data only via EDI - Customer Product Data is provided via EDI individually to each respective Amgen country Affiliate.
[Per the agreed
Transition Date]
GSK and Amgen
 
 
 
8
Material
Activity
GSK Detailing
For each country, GSK will continue to Detail Prolia as outlined in the 2014 Brand Plan as implemented by the respective Country Plan agreed as of March 31st 2014; Country Teams can agree to modify the Country Plans for their country only if the Parties mutually agree; if the Parties do not agree on changes, the existing Country Plan as of March 31st 2014 remains valid.

GSK will continue to fulfill its agreed 2014 Brand Plan obligations at HQ level until the end of the transition period in each country unless otherwise mutually agreed by GSK and Amgen HQ team.

During the transition period, the Parties anticipate that there will be no new materials generated for use by GSK Reps. Any new materials to be used by GSK Reps will need to be approved by GSK commercial and medical. Training for GSK Reps on new materials: Amgen will create the material and it will be reviewed and executed by GSK.
[Per the agreed
Transition Date]
GSK and Amgen
 
 
 
9
Material
Activity
GSK Handover
Services
GSK will make reasonable efforts to facilitate a Face to Face introduction between Amgen Reps/CSO and Physicians nurse/payer in accordance with data privacy requirements. Country Teams to decide timeline and prioritization of introduction taking into account transition timelines (introduction can only occur once consent has been received from Physician/nurse/payer). If Parties do not agree, prioritization to be decided by Amgen. Prioritization to take into consideration the remainder of transition time and data privacy requirements re Physician/nurse/payer.
[Per the agreed
Transition Date]
GSK and Amgen
 
 
 
10
Material
Activity
GSK Handover
Services
For each country in the Transition Territory, there will be 1 Country Team meeting per calendar month until end of Transition Date. The County Team members may invite ad hoc guests as agreed to assist with transition of activities/handover to Amgen. Joint country teams can decide to meet more frequently if needed at local level.
[Per the agreed
Transition Date]
GSK and Amgen
 
 
 
11
Other
GSK General
Transition Services
GSK to continue providing support re Medical Inquiries as set out under the former Collaboration Agreement until the end of the country transition period.
[Per the agreed
Transition Date]
GSK and Amgen
 
 
 





12
Other
Pharmacovigilance
GSK to execute its obligations under the existing Pharmacovigilance Agreement between Amgen and GSK, inter alia to do adverse event reporting from physicians/prescribers until 31 December 2014.
[Per the agreed
Transition Date]
GSK
 
 
 
13
Other
Governance
Amgen and GSK to appoint one Transition Manager at HQ (European level) only.
[Per the agreed
Transition Date]
GSK and Amgen
 
 
Transition Managers only to
be appointed by Regional Amgen and GSK Headquarters; no country transition managers will be appointed as there are Country Teams in place
14
Other
Regulatory
Amgen and GSK to ensure all regulatory approvals obtained in order to effect labeling change (ie to remove "GSK" from product labelling).
[Per the agreed
Transition Date]
GSK and Amgen
 
 
 






SCHEDULE 3.4(b)

Transition Budget



Please see attached.

36



TRANSITION BUDGET
GSK Opex in USD by country and quarter
Sum of Amnt USD @ Bdgt Fx Rate
Q2
Q3
Q4
TOTAL (Q2-Q4)
 
 
 
 
 
Austria
293,032
 
293,032
External Cost
18,392
 
 
18,392
FTE Expenses
274,640
 
 
274,640
 
 
 
 
 
Belgium
643,534
(643,534)
External Cost
56,904
 
 
56,904
FTE Expenses
586,630
 
 
586,630
 
 
 
 
 
Bulgaria
19,601
19,601
External Cost
15,505
 
 
15,505
FTE Expenses
4,096
 
 
4,096
 
 
 
 
 
CEE HQ Vienna
0
External Cost
 
 
 
FTE Expenses
 
 
 
 
 
 
 
 
Croatia
98,364
98,364
External Cost
27,240
 
 
27,240
FTE Expenses
71,124
 
 
71,124
 
 
 
 
 
Cyprus
29,466
29,466
External Cost
6,882
 
 
6,882
FTE Expenses
22,584
 
 
22,584
 
 
 
 
 
Czech
40,884
40,884
External Cost
2,613
 
 
2,613
FTE Expenses
38,271
 
 
38,271
 
 
 
 
 
Denmark
58,586
58,586
External Cost
8,323
 
 
8,323
FTE Expenses
50,264
 
 
50,264
 
 
 
 
 
Estonia
30,962
30,962
External Cost
13,376
 
 
13,376
FTE Expenses
17,586
 
 
17,586
 
 
 
 
 
Finland
89,674
89,674
External Cost
10,835
 
 
10,835
FTE Expenses
78,839
 
 
78,839
 
 
 
 
 
France
2,985,707
2,985,707
5,971,414
External Cost
731,015
731,015
 
1,462,030
FTE Expenses
2,254,692
2,254,692
 
4,509,384
 
 
 
 
 
Germany
2,196,677
2,196,677
External Cost
366,511
 
 
366,511
FTE Expenses
1,830,166
 
 
1,830,166
 
 
 
 
 
Greece
600,479
600,479
External Cost
148,811
 
 
148,811
FTE Expenses
451,667
 
 
451,667
 
 
 
 
 
HQ
311,470
311,470
622,940
External Cost
 
 
 
FTE Expenses
311,470
311,470
 
622,940
 
 
 
 
 
Ireland
238,235
158,823
397,058
External Cost
23,409
15,606
 
39,015
FTE Expenses
214,826
143,217
 
358,043
 
 
 
 
 
Italy
74,698
74,698
External Cost
 
 
 
 
FTE Expenses
74,698
 
 
74,698
 
 
 
 
 
Lithuania
53,408
53,408
External Cost
7,585
 
 
7,585
FTE Expenses
45,823
 
 
45,823
 
 
 
 
 
Mexico
329,346
329,346
External Cost
118,498
 
 
118,498
FTE Expenses
210,848
 
 
210,848
 
 
 
 
 
Norway
76,629
76,629
External Cost
7,919
 
 
7,919
FTE Expenses
68,709
 
 
68,709
 
 
 
 
 
Poland
56,887
56,887
External Cost
39,507
 
 
39,507
FTE Expenses
17,380
 
 
17,380
 
 
 
 
 
Romania
55,477
55,477
External Cost
36,652
 
 
36,652




TRANSITION BUDGET
GSK Opex in USD by country and quarter
Sum of Amnt USD @ Bdgt Fx Rate
Q2
Q3
Q4
TOTAL (Q2-Q4)
FTE Expenses
18,825
18,825
 
 
 
 
 
Russia
111,236
11,236
External Costs
 
 
 
FTE Expenses
111,236
 
 
111,236
 
 
 
 
 
Slovenia
83,830
83,830
83,830
External Cost
9,834
9,834
 
9,834
FTE Expenses
73,996
73,996
 
73,996
 
 
 
 
 
Spain
2,341,598
2,341,598
2,341,598
External Cost
333,746
333,746
 
333,746
FTE Expenses
2,007,852
2,007,852
 
2,007,852
 
 
 
 
 
Sweden
107,245
107,245
107,245
External Cost
3,940
3,940
 
3,940
FTE Expenses
103,305
103,305
 
103,305
 
 
 
 
 
Switzerland
323,064
323,064
323,064
External Cost
56,676
56,676
 
56,676
FTE Expenses
266,388
266,388
 
266,388
 
 
 
 
 
United Kingdom
559,184
559,184
559,184
External Cost
69,893
69,893
 
69,893
FTE Expenses
489,291
489,291
 
489,291
 
 
 
 
 
Grand Total
11,809,271
3,456,000
15,265,271









SCHEDULE 4.5

Binding letter of intent relating to Collaboration Agreement in respect of Ivory in Australia



Please see attached.

37





Amgen Inc. (“Amgen”)
1 Amgen Center Drive
Thousand Oaks
CA 91320
USA

Glaxo Group Limited (“GSK”)
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom


1 April 2014


Binding letter of intent relating to Collaboration Agreement in respect of Ivory in Australia


This Binding Letter of Intent (“Letter of Intent”) is entered into by and between Amgen and GSK (each, a “Party” and, together, the “Parties”) in relation to the Collaboration Agreement (as defined below) in respect of Ivory (as defined in the Collaboration Agreement) in Australia.

Background

On 26 July 2009, Amgen and GSK entered into a collaboration agreement with respect to the commercialization of Ivory in the Collaboration Territory (as defined therein), as amended (collectively, the “Collaboration Agreement”).

On the date first written above (the “Execution Date”), the Parties have entered into a termination and transition agreement (the “TTA”), pursuant to which they have agreed to terminate the Collaboration Agreement and to transfer to Amgen and/or its Affiliates the activities assigned to GSK and related rights granted to GSK under the Collaboration Agreement in all countries of the Collaboration Territory except Australia, with effect from 1 April 2014. Furthermore, the Parties have agreed to amend the Collaboration Agreement with respect to Australia, with the intention that the Parties shall enter into an Australia Agreement (as defined below) on or before 1 September
2014.

The Parties wish to outline in this Letter of Intent the main terms to be contained in the Australia Agreement; it being understood that, in the event that no Australia Agreement is entered into between the Parties on or before 1 September 2014, the terms set out in this Letter of Intent (including the terms of the Collaboration Agreement but solely to the extent referenced herein) shall apply with respect to Australia as from 1 September 2014 until such time as an Australia Agreement is entered into between the Parties.

1





1.
DEFINITIONS

1.1.
The following terms used in this Letter of Intent shall have the meanings set forth below, and any other capitalized terms used but not otherwise defined in this Letter of Intent shall have the meanings ascribed to such terms in the Collaboration Agreement.

1.1.1.
“Australia Agreement” means an Amended and Restated Collaboration Agreement with respect to the Detailing and commercialization of Ivory in Australia to be entered into between all the Parties and such other Affiliates of either Party as such Party deems necessary in its sole discretion;

1.1.2.
Effective Date” means, with respect to this Letter of Intent, 1 September 2014 if the Australia Agreement has not been executed by the Parties on such date;

1.1.3.
Substantive Provisions” means all Sections of this Letter of Intent (including the terms of the Collaboration Agreement but solely to the extent referenced as continuing to apply in this Letter of Intent) other than those that came into effect on the Execution Date hereof in accordance with Section 6.2; provided, that the Parties may agree in the Australia Agreement that terms of the Collaboration Agreement in addition to those set forth in the Letter of Intent continue to apply; and

1.1.4.
Term” means, as applicable, (i) with respect to this Letter of Intent, the period as from the Effective Date until the date on which the Australia Agreement executed by the Parties becomes effective, or (ii) with respect to the Australia Agreement, the term of the Australia Agreement.

1.2.
References to Sections and Schedules are to sections and schedules of this Letter of Intent unless otherwise specified.


2.
GENERAL OBLIGATIONS OF THE PARTIES

2.1.
Promptly after the Execution Date, the Parties shall enter into good faith negotiations with respect to the terms of the Australia Agreement, with the intention of keeping the main principles of the Collaboration Agreement but with amendments to reflect appropriate adjustments for a single country collaboration in a manner aimed at maximizing the benefits of collaboration in Australia to both Parties, and taking into consideration each of the Party’s contributions to establishment of the Ivory business in Australia under the Collaboration Agreement. Notwithstanding the foregoing, the Australia Agreement shall incorporate the Substantive Provisions.

2.2.
The Parties shall use Commercially Reasonable Efforts (as defined in the TTA) to procure that the Australia Agreement shall be entered into between the Parties on or before 1 September 2014.


3.
SCOPE AND GOVERNANCE

3.1.
General. The governance structure set out in the Collaboration Agreement shall continue to apply, subject to the amendments set out in this Section 3.

2




3.2.
Governing Bodies. The collaboration will be primarily governed by the Australia Country Team, with decisions made by consensus. The following bodies shall no longer exist, unless otherwise agreed between the Parties: the CRC, the JSC, the JBT and the JDC, and, subject to the other provisions of this Section 3.3, their activities shall be carried on as the Australia Country Team shall determine.

3.3.
Escalation. In the event of a deadlock, the decision will be made by the members of the Country Team appointed by Amgen, provided that members appointed by either Party will have the right to require that such issues be escalated to the designated senior representative from GSK and the designated senior representative from Amgen in Australia (being the General Manager for Australia for each such Party unless otherwise notified in writing to the other Party) for determination. Any dispute that cannot be resolved by the aforementioned senior representatives within 10 Business Days (as defined in the TTA) may be escalated by either Party to a senior management member from each Party (being a Regional Vice President (or his or her designee) in the case of Amgen and the SVP & General Manager, Asia Pacific and Emerging Markets (or his or her designee) in the case of GSK). Any dispute that cannot be resolved by the aforementioned senior management members within 10 Business Days will be finally decided by Amgen; provided, that the following parameters shall apply to such final decision-making authority: if the Parties cannot mutually agree (i) with respect to an annual sales forecast, then such annual forecast shall not exceed the previous year’s forecast by more than ten percent (10%); and (ii) with respect to Performance Metrics, then such Performance Metrics shall be based substantially on industry standard for the Australia osteoporosis market as determined by a reputable service such as Cegedim Promotional Monitor. In the event of a decision that requires exigent action pursuant to Applicable Law or to prevent a material adverse effect on Ivory or a Party, the members of the Country Team appointed by Amgen will have the right to make an interim decision pending completion of the deadlock escalation mechanism outlined above.


4.
COLLABORATION ACTIVITIES – ALLOCATION AND REPORTING; PERFORMANCE STANDARDS

4.1.
General. The structure set out in the Collaboration Agreement in respect of the allocation and reporting, and performance standards, of collaboration activities shall continue to apply, subject to the amendments set out in this Section 4.

4.2.
Amgen Participation. From 1 January 2015, Amgen will have the right, but not the obligation, to contribute up to fifty percent (50%) of the minimum number of full-time equivalent primary care sales representatives, either by Amgen sales representative employees and/or CSO (as defined in the TTA) sales representatives for Detailing Ivory in Australia. Amgen will provide written notice to GSK at least six (6) months prior to the date which Amgen desires to commence or increase its primary care Detailing in Australia setting forth the amount by which Amgen intends to increase its Detailing responsibilities. In the event that Amgen wishes to contribute a portion of the minimum number of primary care sales representatives in Australia by adding incremental primary care sales representatives in lieu of replacing GSK’s primary care sales representatives, then an incremental increase in sales forecasts to justify the cost associated with such incremental increase in sales representatives shall be agreed in accordance with the standard budgeting process provided under the Collaboration Agreement and subject to the provisions of Section 3.3 above.

4.3.
Performance Standards and Detailing Activities. The Parties shall determine on an annual basis, based on timings which align with the global business plan cycles of Amgen and GSK, business plans (“Business Plans”) setting out sales forecasts for following years as well as performance obligations of GSK and Amgen that shall apply in respect of the following calendar year, in accordance with the principles set out

3




in Part 1 and Part 2 of Schedule 4.3, as applicable, it being acknowledged that these principles may be subject to adjustment based on reasonable business judgment to take account of changes in the brand strategy for Ivory during the Term, including, without limitation and by way of example only, label or other access limitations, changes to the competitive environment or safety events.




5.
FINANCIAL TERMS

5.1.
Article 5 (Up-Front Payment and Milestones) of the Collaboration Agreement are unconditionally and irrevocably terminated as from the Execution Date.

5.2.
The principles of the Collaboration Profit/Loss sharing set out in Article 6 of the Collaboration Agreement shall apply during the Term, with the exception that costs incurred for activities such as R&D, Regulatory Filings, Regulatory Approvals, and Prosecution and Maintenance of Ivory’s Intellectual Property would be included in the profit/loss sharing solely to the extent such costs are specifically for the benefit of Ivory in Australia and without prejudice to the provisions contained in Schedule 4.3 in respect of penalties. For illustrative purposes only, a clinical trial conducted in Australia solely for the support of a Regulatory Approval in Australia will be included in the Collaboration Profit/Loss, but costs of a clinical trial conducted globally which may support Regulatory Approval in Australia but is not solely for the purpose of Regulatory Approval in Australia will not be included in the Collaboration Profit/Loss.

5.3.
Each Party shall bear all costs incurred by it or any of its Affiliates in connection with the preparation and negotiation of, and the entry into, this Letter of Intent and the Australia Agreement.


6.
TERM; TERMINATION

6.1.
General. The provisions relating to expiry, term, termination, effects of termination and transition set out in the Collaboration Agreement shall continue to apply, subject to the amendments set out in this Section 6.

6.2.
Term. The following Sections of this Letter of Intent shall become effective and binding on the Parties on the Execution Date, and shall continue until the date on which an Australia Agreement executed by the Parties becomes effective and binding on the Parties: Section 1, Section 2, Section 6.2, and Section 7. The Substantive Provisions shall become effective on the Effective Date and shall continue until the date on which the Australia Agreement executed by the Parties becomes effective and binding on the Parties (if such date is later than 1 September 2014).

6.3.
Termination. If the sales of Ivory during any two (2) year period of the Term are less than sixty (60%) percent of the total amount forecast for such period (as set forth in the relevant Business Plan), then either Party shall have the right to terminate the Letter of Intent or the Australia Agreement during the Term (as applicable) upon six (6) months’ written notice. In the event of such termination, the Parties will discuss and agree to the fair market value of GSK’s remaining interest over the remainder of the Term of the Letter of Intent or Australia Agreement (including, for the avoidance of doubt, the Tail Period as defined in the Collaboration Agreement), and Amgen shall pay such agreed amount to GSK after termination thereof.

4




7.
MISCELLANEOUS

7.1.
Other provisions of the Collaboration Agreement. Notwithstanding the generality of Section 2.1, Article 7 (Payments), Article 8 (Distracting Products), Article 9 (Intellectual Property), Article 10 (Regulatory and Safety), Article 11 (Confidentiality, Publications and Press Releases), Article 12 (Representations and Warranties), Article 13 (Indemnification and Insurance), Section 14.11 (Tail Payments), and Article 15 (Change of Control) of the Collaboration Agreement shall continue to apply during the Term of this Letter of Intent in accordance with their terms.

7.2.
Dispute Resolution. In the event of any controversy or dispute arising out of or relating to any provision of this Letter of Intent, the construction, validity or breach thereof, the Parties will try to settle the same amicably between themselves. If the Parties fail to settle such matter within thirty (30) days of it having arisen, such matter will be exclusively and finally resolved by binding arbitration under the Rules of Arbitration of the International Chamber of Commerce (the “Rules”) before a panel of three (3) arbitrators selected in accordance with the Rules. The place of the arbitration will be Sydney, Australia and the language of the arbitration will be English. In the event of a dispute involving the alleged breach of this Letter of Intent, neither Party will have the right to terminate performance of its obligations hereunder until resolution of the dispute pursuant to this Section 7.2, and any time period for cure will commence only after such resolution. Any disputed performance or suspended performance pending the resolution of a dispute involving the alleged breach of this Letter of Intent that the arbitration panel determines to be required to be performed by a Party must be completed within a reasonable time period following the final decision of the arbitration panel. The final arbitration award will be final and binding upon both parties and may be entered in any court of competent jurisdiction for enforcement. The arbitrators will have the power to grant monetary damages as well as injunctive or other specific relief. Notwithstanding the foregoing, each party will have the right to seek, without establishment of the arbitral tribunal, injunctive or other provisional relief from a court of competent jurisdiction that may be necessary to avoid irreparable harm or preserve the subject matter of a dispute. Each Party will bear its own costs and expenses and attorneys’ fees, and the Party that does not prevail in the arbitration proceeding will pay the arbitrators’ fees and any administrative fees of arbitration.

7.3.
Choice of Law. This Letter of Intent will be governed by, and enforced and construed in accordance with, the laws of the State of New York, USA, without regard to its conflicts of law provisions. The United Nations Convention for the International Sale of Goods will not apply to the transactions contemplated herein.

7.4.
Boilerplate. The following provisions of the Collaboration Agreement shall apply in respect of this Letter of Intent and are accordingly incorporated by reference herein: the provisions that relate to ‘Confidential Treatment of Treatment of Terms and Conditions’ (Section 11.3), ‘Assignment’ (Section 16.3), ‘Construction’ (Section 16.6), ‘Counterparts’ (Section 16.7), ‘Entire Agreement’ (Section 16.9), ‘Headings’ (Section 16.12), ‘Notices’ (Section 16.14), , ‘Severability’ (Section 16.16) and ‘Waivers and Modifications’ (Section 16.19).




5



The Parties have executed this Letter of Intent on the date and year first above written.


GLAXO GROUP LIMITED

By:
/s/ Paul Williamson
Name:
Paul Williamson
Title:
 

AMGEN INC.
By:
/s/ Carsten Thiel
Name:
Dr. Carsten Thiel
Title:
Regional General Manager, VP Europe













Schedule 4.3

Performance Metrics

Targets for each activity will be agreed by the Parties in accordance with Section 3 every year for execution 1
January the following year.
Targets are based on industry standards and brand strategy

Part 1 – Performance Metrics Applicable to GSK

1. Ivory contribution
At least 60% of all calls are Ivory first line

2. Total customers
Each representative will have between 90-300 Ivory customers with team average of at least 175
This target will be redefined every year based on brand strategy

3. Target A&B customers
At least 65% of all customers will be Ivory A&B targets
A&B customers will be defined according to GSK's established processes and principles for classification and targeting
All customer lists will be shared and agreed with Amgen in the first calendar quarter of each year for which such customer lists apply

4. Minimum volume calls
There will be a minimum volume of calls to be delivered based on: minimum 5 calls per day on A&B customers per representative total 7 calls per day on all customers per representative

5. Coverage
Greater than 90% coverage of all A&B customers per semester (half year)

6. Customer potential
Customer targets contribution will be indexed according to brick potential
Top 100 bricks comprise greater than 20% market potential
At least 20% of A&B customers will fall within top 100 bricks

7. Frequency
Average frequency for all A&B customers will be at least 6 calls/annum

8. Penalties
Any calls not made to reach minimum call volume on all customers and/or A&B customers will not be charged to the
Collaboration
Rate based on cost per call

9. Other
Planned calls to designated healthcare professional groups, and peer-to-peer speaker activities.

7





Schedule 4.3

Part 2 – Performance Metrics Applicable to Amgen

The Performance Metrics in this Part 2 of Schedule 4.3 apply to specialist sales representatives. If Amgen engages in Detailing to primary care practitioners, then the Performance Metrics set forth in Part 1 of Schedule 4.3 shall apply.



1. Ivory contribution
100% of all calls are Ivory first line

2. Total customers
Each representative will have between 90-150 Ivory customers with team average of 100

3. Target A&B customers
At least 70% of all customers will be Ivory A&B targets
AB&C customers will be defined following Amgen's established process

4. Minimum volume calls
There will be a minimum volume of calls to be delivered based on:

minimum 4 calls per day on AB&C customers per representative total of 5 calls per day on all customers per representative

5. Coverage
100% coverage of all AB&C customers per semester

6. Frequency
Average frequency for all A&B customers will be at least 8 calls/annum
Average frequency for all C customers will be at least 4 calls/annum

7. Penalties
Any calls not made to reach minimum call volume on all customers and/or AB&C customers will not be charged to the Collaboration
Rate based on cost per call

8. Other
Planned calls to designated healthcare professional groups, and peer-to-peer speaker activities.


8





SCHEDULE 9.1.1.2

Milestone A

• Germany
• Italy
• Belgium
• Greece
• Slovenia

38





SCHEDULE 9.1.1.3


Milestone B


• France
• Spain
• Switzerland
• United Kingdom

39





ANNEX A

Collaboration Agreement
Between
Amgen Inc and Glaxo Group Limited Dated July 27, 2009 as amended



Please see attached.

40



























COLLABORATION AGREEMENT

BY AND BETWEEN

AMGEN INC.

AND

GLAXO GROUP LIMITED




TABLE OF CONTENTS

1
DEFINITIONS
7

2
SCOPE AND GOVERNANCE
19

 
Purpose of the Collaboration
19

 
Co-Exclusive Appointment
 
 
Governance
19

 
Decision Making Standards
19

 
Membership
19

 
Replacement of Members
20

 
Establishment of Subcommittees
20

 
No Authority to Amend or Modify
20

 
Collaboration Oversight Committee
20

 
Meetings
20

 
Decision Making
20

 
Joint Steering Committee.
20

 
Meetings.
21

 
Reporting
21

 
Decision Making
21

 
Joint Brand Team
22

 
Meetings.
22

 
Reporting
22

 
Decision Making
22

 
Joint Development Committee
23

 
Meetings
23

 
Reporting
23

 
Decision Making
23

 
Country Teams.
23

 
Meetings
24

 
Reporting
24

 
Decision Making
24

 
Patent Coordinators
24

 
Alliance Managers
25

 
Territorial Expansion
25

 
Internal Governance
26

3
COLLABORATION ACTIVITIES - ALLOCATION AND REPORTING
26

 
Allocation of Operational Responsibility
26

 
Country Plans
26

 
Designated GSK Activities
26

 
Designated Amgen Activities
26

 
Collaboration in Commercialization Activities
27

 
Amgen Participation Increase and Transition
27

 
Participation Increase
27

 
Potential Quid
27

 
All Sales by Amgen
27

 
Training.
27


2




 
Information Concerning Ivory
28

 
Public Statements
28

 
Ownership
28

 
Promotional Materials
28

 
Detailing Reports and Audit Rights
29

 
Reporting.
29

 
Audits
29

 
Medical Inquiries and Product Inquiries
29

 
Samples
30

 
Non-Commercial Activities
30

 
Research and Development
30

 
Regulatory
30

 
Safety
30

 
Manufacturing
31

4
COLLABORATION ACTIVITIES - PERFORMANCE STANDARDS
32

 
Collaborative Activities
32

 
Diligence and Performance Standards.
32

 
Detailing Activities
33

 
Minimum Sales Activities
33

 
Sales Force Minimum
33

 
Sales Force Incentive Compensation
34

 
Violation of Laws
34

 
Use of Affiliates and Third Party Contractors
34

 
Affiliates
35

 
Management of Personnel
35

 
COGS
35

5
UP-FRONT PAYMENT AND MILESTONES
 35

 
Payments by GSK
35

 
Up-Front Payment
35

 
Milestone Payment
35

 
Payment Method
36

6
PROFIT/EXPENSE SHARING
 36

 
Sharing
36

 
GSK Costs
36

 
Amgen Costs
36

 
FTE Rate
38

 
Income Taxes
38

 
Exchange Rate
38

 
Budget and Overruns
38

 
Preparation; Updating
38

 
Overruns
38

 
Ivory Net Revenues
39

 
Calculation of Profit (or Loss
39

 
True-up
39

 
Calculation of Sales Force Co
39

 
Example
40


3



 
Calculation of Net Revenues
40

 
Free Products
40

 
Bundled Products
40

 
Attribution of Costs
40

 
Collaboration Losses
40

7
PAYMENTS
 41

 
Appropriate Measure of Value
41

 
No Other Compensation
41

 
Payment Method
41

 
Audits
41

 
Blocked Currency
42

 
Withholding
42

 
VAT
43

 
Late Payment
43

 
Change in Accounting Periods
43

8
DISTRACTING PRODUCTS
 43

 
Distracting Program
43

 
Post-Effective Date Affiliate
43

 
Termination or Dives
44

 
Divestiture
44

 
Termination
44

 
Pre-Effective Date Programs
44

 
Reasonable Restrictions
45

 
Amgen Restrictions
45

 
Segregation of Programs
45

9
INTELLECTUAL PROPERTY
 46

 
Invention Ownership
46

 
Copyright Ownership; Certain Confidential Information
46

 
Joint Ownership
46

 
License Grant by Amgen
46

 
License Grant by GSK
47

 
No Challenge
67

 
Prosecution and Maintenance
47

 
Defense and Settlement of Third-Party Claims
47

 
Enforcement
48

 
Patent Term Extensions
48

 
Employee Agreements
48

 
Trademarks.
48

 
Title
48

 
Required Use and Compliance
49

 
Licenses
49

 
To GSK
49

 
To Amgen
49

 
Respect of Trademarks
50

 
Infringement
50

 
Community Of Interest
50


4



10
REGULATORY AND SAFETY
 50

 
Regulatory Matters
50

 
Regulatory Communication and Filings
50

 
Regulatory Meetings
51

 
GSK Obligations
51

 
Labeling and Packaging Materials
52

 
Regulatory and Safety Information
52

 
Brand Security and Anti-Counterfeiting
53

 
Product Technical Complaints; Recalls; Returns
53

 
Product Technical Complaints
53

 
Recalls or Other Corrective Action
53

 
Returns
53

 
Clinical Trial Register
54

11
CONFIDENTIALITY, PUBLICATIONS AND PRESS RELEASES
 54

 
Confidentiality; Exceptions
54

 
Authorized Disclosure
54

 
Confidential Treatment of Terms and Conditions
55

 
Press Releases
55

 
Prior Agreement
56

 
Publications and Program Information
56

 
Attorney-Client Privilege
56

 
Injunctive Relief
57

 
Additional Permitted Disclosure
57

12
REPRESENTATIONS AND WARRANTIES
 57

 
Mutual Representations and Warranties
57

 
Amgen Representations and Warranties
58

 
Amgen Covenants
59

 
GSK Representations and Warranties
59

 
GSK Covenants
59

 
Disclaimer of Warranties
60

 
Limitation of Liability
60

 
Covenants
60

13
INDEMNIFICATION AND INSURANCE
 61

 
Indemnity by GSK
61

 
Indemnity by Amgen
61

 
Specific Indemnity
61

 
Claim for Indemnification
62

 
Defense of Third Party Claims
62

 
Insurance.
63

14
TERM AND TERMINATION
 64

 
Term
64

 
Termination for Breach
64

 
Termination for Insolvency
65

 
Early Termination by Amgen
65

 
Termination Discussion
66

 
Valid Safety Issue
66


5



 
Failure to Supply
67
 
Effects of Expiration or Termination
67
 
Accrued Obligations
67
 
Promotion Rights; Licenses
67
 
Product Data and Amgen Confidential Information
67
 
Return of Samples and Materials
68
 
Assignment of Filings and Registrations
68
 
Survival
68
 
Transition
69
 
Tail Payments
69
 
No Limitation of Rights
70
15
CHANGE OF CONTROL
 70
 
Change of Control of GSK
70
 
Change of Control of Amgen
71
16
MISCELLANEOUS
 72
 
Affiliates
72
 
Arbitration
72
 
Assignment
72
 
Choice of Law
72
 
Compliance with Applicable Law
73
 
Construction
73
 
Counterparts
73
 
Currency
73
 
Entire Agreement
73
 
Force Majeure
74
 
Further Assurances
75
 
Headings
75
 
No Set-Off
75
 
Notices
75
 
Relationship of the Parties
76
 
Severability
77
 
Standstill
77
 
Third-Party Beneficiaries
79
 
Waivers and Modifications
79



6





COLLABORATION AGREEMENT

This Collaboration Agreement (this “Agreement”) is entered into as of the 27th day of July, 2009 (the “Effective Date”) by and between Amgen Inc., a Delaware corporation with a place of business at 1 Amgen Center Drive, Thousand Oaks, CA 91320 (“Amgen”) and Glaxo Group Limited, registered in England as company number 305979, doing business as “GlaxoSmithKline” and having its principal office at Glaxo Wellcome House, Berkley Avenue, Greenford, Middlesex, UB6 0NN, United Kingdom (“GSK”). Amgen and GSK are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

RECITALS

WHEREAS, Amgen is a biotechnology company that researches, develops, manufactures and commercializes novel therapeutics to treat grievous illness;

WHEREAS, Amgen has developed the proprietary product Ivory (as defined below) for the treatment of certain diseases and conditions;

WHEREAS, Amgen and GSK desire to collaborate with respect to the commercialization of Ivory as set forth in more detail herein;

WHEREAS, Amgen and GSK desire to share certain expenses and revenues with respect to Ivory as set forth in more detail herein; and

WHEREAS, Amgen and GSK are entering into a separate agreement of even date herewith whereby GSK will conduct certain activities with respect to Ivory as specified therein in the Expansion Territory (as defined therein).

NOW, THEREFORE, in consideration of the premises and the mutual promises set forth herein, and intending to be legally bound, the Parties agree as follows:

1.
DEFINITIONS

1.1.
“Affiliate” means, with respect to a Party, any Person which controls, is controlled by or is under common control with such Party. For purposes of this Section 1.1, “control” means: (i) in the case of corporate entities, direct or indirect ownership of fifty percent (50%) or more of the stock or shares entitled to vote for the election of directors; and (ii) in the case of non-corporate entities, direct or indirect ownership of more than fifty percent (50%) of the equity or income interest therein (or, in each of (i) and (ii), if applicable, such lesser percentage that is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction).

1.2.
“Agreement” has the meaning set forth in the Preamble.

1.3.
“Alliance Manager” has the meaning set forth in Section 2.15 (Alliance Mangers).

1.4.
“Allocable Overhead” means overhead costs (including Employment Costs and Third Party costs) related to the manufacture or support of the manufacturing of a product (including quality, process development and process improvements). Allocable Overhead costs are Indirect Costs and include all costs for supervisory services, occupancy and similar functions and activities customarily treated as overhead, including costs attributable to: (i) depreciation of or rent/lease expenses for property, facilities and capital equipment; (ii) company and facilities management (e.g.,

7





supervisors, human resources and purchasing); (iii) facilities services, security, surveillance, environmental protection, utilities, maintenance and repair (e.g., engineering and production planning); (iv) logistical costs; (v) finance and accounting support, data processing, legal affairs, training and information systems services; (vi) insurance (e.g., fire, product liability and business interruption insurance); (vii) indirect materials, supplies and consumables; (viii) general services (e.g., telephones, fax, postal services, copying and office services and equipment, cleaning, health services, and energy maintenance); (ix) process development (optimization/characterization), process validation, quality assurance and quality control costs; (x) internal/external efforts required to complete and submit any regulatory or governmental approval relating to the manufacture of Ivory or a facility manufacturing Ivory; (xi) product and inventory losses; and (xii) cycle count adjustments. Allocable Overhead may be allocated based upon percent of effort, resource utilization or other reasonable measure. For the avoidance of doubt, Allocable Overhead does not include costs of initial process development performed for scale up purposes prior to the launch of Ivory, or significant manufacturing process changes unless and until such significant manufacturing process changes are successfully implemented for Ivory.

1.5.
“Amgen” has the meaning set forth in the Preamble.

1.6.
“Amgen Costs” has the meaning set forth in Section 6.1.2 (Amgen Costs).

1.7.
“Amgen Housemarks” means the corporate logo of Amgen, the trademark “Amgen” and any other related trademark, trade name or service mark (whether registered or unregistered) containing the word “Amgen” and all intellectual property rights residing in the foregoing.

1.8.
“Amgen’s Patent Attorneys” means Amgen’s in-house patent attorney, Scott Ausenhus, and agent, Robert Winter, primarily responsible for patent matters with respect to Ivory in the Collaboration Scope.

1.9.
“Amgen Sales Force Costs” means the allocable share of Amgen’s (or its Affiliates’) sales force costs for sales representatives responsible for Detailing Ivory in the Collaboration Scope in accordance with this Agreement, calculated in accordance with Section 6.1.10 (Calculation of Sales Force Costs).

1.10.
“Annual Cap” has the meaning set forth in Section 6.1.6.1 (Preparation; Updating).

1.11.
“Applicable Laws” means, individually and collectively, any federal, state, local, national and supra-national laws, treaties, statutes, ordinances, rules and regulations, including any rules, regulations, guidance, guidelines or requirements having the binding effect of law of national securities exchanges, automated quotation systems or securities listing organizations, Governmental Authorities, courts, tribunals, agencies other than Governmental Authorities, legislative bodies and commissions that are in effect from time to time during the Term and applicable to a particular activity hereunder.

1.12.
“Assisting Party” has the meaning set forth in Section 13.5 (Defense of Third Party Claims).

1.13.
“Audited Party” has the meaning set forth in Section 7.4 (Audits).

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1.14.
“Auditing Party” has the meaning set forth in Section 7.4 (Audits).

1.15.
“Brand Book” means the Product Trademark usage and style guide for Ivory established and updated from time-to-time by the JBT.

1.16.
“Brand Plan” means the brand plan for Ivory established by the JBT.

1.17.
“Bundle” means Ivory sold together with another pharmaceutical compound for a single price.

1.18.
“Change of Control” means: (i) the acquisition, directly or indirectly, by any person, entity or “group” (within meaning of Section 13(d)(3) or 14(d)(2) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) by means of a transaction or series of related transactions, of (a) beneficial ownership of fifty percent (50%) or more of the outstanding Voting Securities of a Party (or the surviving entity, as applicable, whether by merger, consolidation, reorganization, tender offer or other similar means), or (b) all, or substantially all, of the assets of a Party and its Affiliates; or (ii) any consolidation or merger of a Party with or into any Third Party, or any other corporate reorganization involving a Third Party, in which those persons or entities that are stockholders of the Party immediately prior to such consolidation, merger or reorganization (or prior to any series of related transactions leading up to such event) own fifty percent (50%) or less of the surviving entity’s voting power immediately after such consolidation, merger or reorganization.

1.19.
“Change of Control Notice” has the meaning set forth in Section 15.2 (Change of Control of Amgen).

1.20.
“COGS” means the Standard Cost for Ivory adjusted to reflect the sum of actual Direct Costs and Indirect Costs for the Inventory Layer from which such Ivory was taken less, to the extent not previously deducted, net non-refundable taxes or duties and distribution and warehousing costs. COGS will be calculated consistently with other products and in accordance with GAAP.

1.21.
Collaboration 2022 Profit Share” has the meaning set forth in Section 14.11.3.

1.22.
“Collaboration Budget” has the meaning set forth in Section 2.10 (Joint Steering Committee).

1.23.
“Collaboration Field” means the use of Ivory in any Collaboration SKU (including 60mg Collaboration SKU presentations) for the treatment, palliation or prevention of one (1) or more of the following diseases and conditions in humans: (i) post- menopausal osteoporosis; (ii) glucocorticoid induced osteoporosis; and (iii) male osteoporosis. The Collaboration Field does not include the Excluded Field.

1.24.
“Collaboration Losses” has the meaning set forth in Section 6.5 (Collaboration Losses).

1.25.
“Collaboration Review Committee” or “CRC” means the committee established to resolve issues in accordance with Article 2 (Scope and Governance).

1.26.
“Collaboration Profit (Loss)” has the meaning set forth in Section 6.1.8 (Calculation of Profit (or Loss)).

1.27.
“Collaboration Scope” means the Collaboration Field in the Collaboration Territory.

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1.28.
“Collaboration SKUs” means those SKUs pursued by Amgen and labeled for use for the treatment, palliation or prevention of one (1) or more of the following diseases and conditions in the Collaboration Territory in humans: (i) post-menopausal osteoporosis; (ii) glucocorticoid induced osteoporosis; and (iii) male osteoporosis.

1.29.
“Collaboration Territory” means those countries set forth on the Collaboration Territory Schedule and any country added pursuant to Section 2.16 (Territorial Expansion).

1.30.
“Collaboration Territory R&D Costs” means those costs incurred by or on behalf of either Party or its Affiliates in connection with research and development of Ivory in accordance with the Development Plan in the Collaboration Field for the primary benefit of the Collaboration Territory (including the costs of Phase IV Trials undertaken in the Collaboration Field for the benefit of the Collaboration Territory); provided, that, notwithstanding anything to the contrary in this Agreement, Collaboration Territory R&D Costs will exclude the costs of all of Amgen’s internal FTEs that are involved in the conduct of research and development, which will be deemed Qualified Amgen R&D Costs.

1.31.
“Commercially Reasonable Efforts” means, with respect to activities of a Party related to Ivory under this Agreement, the efforts and resources typically used by that Party (or, if a Party does not engage in that activity for other products or compounds, by biotechnology and/or pharmaceutical companies that are similar in size and financial resources to such Party) in the conduct of such activities with respect to products of comparable market potential, taking into account all relevant factors including, as applicable, stage of development, efficacy and safety relative to competitive products in the marketplace, actual or anticipated Governmental Authority approved labeling, the nature and extent of market exclusivity (including patent coverage and regulatory exclusivity), cost and likelihood of obtaining Regulatory Approval, and actual or projected profitability. For purposes of clarity, Commercially Reasonable Efforts will be determined on a country-by-country basis within the Collaboration Territory, and it is anticipated that the level of effort may be different for different countries and may change over time, reflecting changes in the status of Ivory and the country(ies) involved.

1.32.
“Contract Interest Rate” means the thirty (30) day U.S. Dollar LIBOR rate effective for the date that payment was due, as published by The Wall Street Journal, Eastern U.S. Edition, on the date such payment was due (or, if unavailable on such date, the first date thereafter on which such rate is available), or, if lower, the maximum rate permitted by Applicable Law.

1.33.
“Copyright” means all right, title, and interest in and to all copyrightable works and any copyright registration or corresponding legal right.

1.34.
“Country Plans” has the meaning set forth in Section 3.2 (Country Plans).

1.35.
“Country Team” means one of the teams overseeing commercialization of Ivory in the Collaboration Field in a given country (or countries) within the Collaboration Territory in accordance with Article 2 (Scope and Governance).

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1.36.
“Designated GSK Activities” means those activities for which GSK is responsible pursuant to Section 3.1 (Allocation of Operational Responsibilities) or 3.3 (Designated GSK Activities).

1.37.
“Defending Party” has the meaning set forth in Section 13.5 (Defense of Third Party Claims).

1.38.
“Detail” means an interactive face-to-face visit by a sales representative with a medical professional having prescribing authority or who is able to influence prescribing decisions, within the target audience during which approved uses, safety, effectiveness, contraindications, side effects, warnings and/or other relevant characteristics of a pharmaceutical product are discussed in an effort to increase prescribing preferences of a pharmaceutical product for its approved uses. Detail includes First Position Details, Second Position Details and Other Details. Activities conducted by medical support staff (such as medical science liaisons) will not constitute Details. E-details, activities conducted at conventions or similar gatherings and activities performed by market development specialists, managed care account directors and other personnel not performing face-to-face sales calls or not specifically trained with respect to a pharmaceutical product will not constitute Details. “Detailing” means the act of performing Details and to “Detail” mean to perform Details.

1.39.
“Detail Report” has the meaning set forth in Section 3.11.1 (Reporting).

1.40.
“Development Budget” means the budget applicable to the Development Plan. The Development Budget applicable to the Initial Development Plan (the “Initial Development Budget”) is attached hereto as the Development Budget Schedule.

1.41.
“Development Plan” means the plan established by the JDC covering: (i) the research and development (including Phase IV Trials) of Ivory in the Collaboration Field for (a) the primary benefit of one (1) or more countries or regions in the Collaboration Territory, or (b) if not for the primary benefit of one (1) or more countries or regions in the Collaboration Territory, then otherwise useful to the Collaboration Scope; (ii) the preparation and submission of Regulatory Filings; and (iii) the obtaining, maintenance or expansion of Regulatory Approvals of Ivory in the Collaboration Scope. The initial Development Plan (the “Initial Development Plan”) covering calendar years 2009 through 2012 is attached hereto as the Development Plan Schedule, and will be reviewed and updated by the JDC on an annual basis or more frequently as agreed by the Parties. For the avoidance of doubt, information contained in the Initial Development Plan covering January 1, 2009 through the Effective Date is provided for informational purposes only, and is not intended to create any obligations on GSK with respect to such development during such period, including the obligation to pay or share any costs associated with such development for such period.

1.42.
“Direct Costs” means all costs incurred by or on behalf of Amgen and/or its Affiliates for resources and rights directly associated with the manufacture of Ivory, including raw materials and finishing supplies used to manufacture Ivory, payments to subcontractors with respect to the manufacture of Ivory, payments (including royalties) to Third Parties for rights used in the manufacture of Ivory, and Employment Costs for personnel directly involved in any aspect of manufacturing Ivory such as equipment operators, line mechanics, set up mechanics and material handlers to supply the line.

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1.43.
“Distracting Product” means: (i) any RANK ligand inhibitor; and (ii) any bisphosphonate.

1.44.
“Distracting Program” means the commercialization (including Detailing, selling, promoting or distributing) of any Distracting Product.

1.45.
“Distracting Transaction” means any transaction entered into by a GSK or its Affiliates after the Effective Date whereby a Third Party that is engaged in a Distracting Program becomes an Affiliate of GSK or any of its Affiliates.

1.46.
“Divest” means, with respect to any Distracting Program, the sale, exclusive license or other transfer of all of the right, title and interest in and to such Distracting Program, including technology, intellectual property and other assets materially relating thereto, to an independent Third Party, without the retention or reservation of any rights or interest (other than solely an economic interest) in such Distracting Program by GSK or its Affiliates.

1.47.
“Effective Date” has the meaning set forth in the Preamble.

1.48.
“EMEA” means the European Medicines Agency, and any successor agency thereto.

1.49.
“Employment Costs” means all actual costs incurred by or on behalf of a Party and/or its Affiliates with respect to any employee.

1.50.
“Excluded Field” means the use of Ivory for any purpose outside the Collaboration Field, including veterinary or diagnostic purposes, and including the use of Ivory for the treatment, palliation or prevention of the following diseases and conditions in humans: (i) bone metastases; (ii) bone loss induced by cancer therapy or hormone ablation therapy; and (iii) cancer-related bone damage.

1.51.
“Excluded Territory” means the United States of America, Canada, Japan, Bahrain, Jordan, Kuwait, Oman, Qatar, Egypt, Morocco, Tunisia, Algeria, Libya, Saudi Arabia, Turkey, the United Arab Emirates and any other country not included within the Expansion Territory (as defined in the Expansion Agreement) and, with respect to each of the foregoing, the territories and possessions thereof.

1.52.
“Expansion Agreement” means the agreement entered into between the Parties of even date herewith, pursuant to which Amgen grants GSK certain rights with respect to Ivory in the Expansion Territory (as defined in the Expansion Agreement).

1.53.
“First Position Detail” means a Detail in which the applicable pharmaceutical product is Detailed before any other product and the predominant portion of time is devoted to the Detailing of such pharmaceutical product.

1.54.
“For Cause Audit” has the meaning set forth in Section 3.14.4 (Manufacturing).

1.55.
“FTE” means, with respect to a person (other than an employee that Details Ivory), the equivalent of the work of one (1) employee full time for one (1) year (consisting of at least a total of 45.5 weeks or 1,820 hours per year (excluding vacations and holidays)). Overtime, and work on weekends, holidays and the like will not be counted with any multiplier (e.g., time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution. For an employee that Details Ivory, FTEs will be calculated as set forth in Section 6.1.10 (Calculation of Sales Force Costs).

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1.56.
“FTE Rate” means, with respect to a particular type of employee and geography, for the period commencing on the Effective Date until such time as the JSC agrees otherwise, the fully-burdened amount set forth on the FTE Rate Schedule per full-time employee per year (as of the Effective Date), which rate will be increased by three percent (3%) of the then-current FTE Rate on January 1 of 2010 and each subsequent calendar year. For the avoidance of doubt, the JSC may agree to continue to use the rates set forth in the FTE Rate Schedule or to use different rates, which may be higher or lower than those set forth in the FTE Rate Schedule. The FTE Rate Schedule will be updated in writing to reflect any such agreement of the JSC.

1.57.
“GAAP” means the then current generally accepted accounting principles in the United States as established by the Financial Accounting Standards Board or any successor entity or other entity generally recognized as having the right to establish such principles in the United States, in each case consistently applied.

1.58.
“GDP” means the applicable provisions governing distribution of medicinal products for human use, including European Commission Directive (2003/94/EC) (principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use), European Commission Guidelines (94/C 63/03) (the Guidelines on Good Distribution Practice of MedicinalProducts or Human Use), European Commission Directive (2001/83/EC)(relating to medicinal products for human use) and any applicable local guidelines in respect of good distribution practice for pharmaceutical products, in each case, as amended.

1.59.
“GMP” means practices with respect to the manufacture of Ivory as required by the following: (i) if Ivory will be supplied to any jurisdiction adopting the International Conference on Harmonisation Guidelines other than the European Union (which is addressed below), ICHQ7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, (ii) if the site of manufacture of Ivory is within the European Union or will be supplied to a country within the European Union, the principles and guidelines of Good Manufacturing Practices for medicinal products as defined within European Commission Directive 2003/94/EC and associated European Union Guidelines to Good Manufacturing Practice, (iii) if the site of manufacture is in the United States of America, provisions of 21 C.F.R. parts 210 and 211, or (iv) if Ivory will be supplied to any other country not falling within (i)-(iii) above, then the requirements shall be no more onerous than the requirements set out in (i)-(iii) above. “ICHQ7” means the ICH Harmonised Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7, as amended from time to time.

1.60.
“Governmental Authority” means any government or supranational administrative agency, commission or other governmental or supranational authority, body or instrumentality, or any federal, state, local, domestic or foreign governmental or supranational regulatory body.

1.61.
“GSK” has the meaning set forth in the Preamble.

1.62.
“GSK Costs” has the meaning set forth in Section 6.1.1 (GSK Costs).



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