AMGN-EX10.55_2014.6.30-Q2






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.



11








		
	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.





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	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.





15










		
	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:



16






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.



18








		
	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



19










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.





20






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).



8










		
	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.



9










		
	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).



10










		
	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.



11










		
	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).



12










		
	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).







13










		
	1.63.
	“GSK  Housemarks”  means  the  corporate  logo  of  GSK,  the  trademarks  “GSK”, “GlaxoSmithKline” and any other related trademark, trade name or service mark (whether registered or unregistered) containing the word “GlaxoSmithKline” and intellectual property rights residing in the foregoing.




		
	1.64.
	“GSK Inventions” means any Invention made solely by GSK or its Affiliates (and not jointly with Amgen or any of its Affiliates) during the Term in the course of performing the activities contemplated hereunder that relates substantially to the composition of matter, formulation or use of Ivory.




		
	1.65.
	“GSK Sales Force Costs” means the allocable share of GSK’s (and/or its Affiliates’) 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).




		
	1.66.
	“IFRS”   means   the   then   current   International   Financial   Reporting   Standards, consistently applied.




		
	1.67.
	“Indirect Costs” means Allocable Overhead and Employment Costs attributed to the manufacture and supply of Ivory, and not included in the definition of Direct Costs.




		
	1.68.
	“Infringement Claim” has the meaning set forth in Section 9.7 (Defense and Settlement of Third Party Claims of Infringement).




		
	1.69.
	“Invention”  means  any  idea,  concept,  discovery,  invention,  improvement  or  trade secret.




		
	1.70.
	“Inventorship Margin” means: (i) ten percent (10%) with respect to calendar year Ivory Net Revenues in an amount less than or equal to Four Hundred Fifty Million Dollars ($450,000,000.00); (ii) five percent (5%) with respect to calendar year Ivory Net    Revenues    in    an    amount    over    Four    Hundred    Fifty    Million    Dollars ($450,000,000.00)    up    to    and    including    Nine    Hundred    Million    Dollars ($900,000,000.00); and (iii) two and one-half percent (2.5%) with respect to calendar year Ivory Net Revenues greater than Nine Hundred Million Dollars ($900,000,000.00).




		
	1.71.
	“Inventory Layer” means all amounts of Ivory manufactured at a specific site during a given calendar year.




		
	1.72.
	“ISS” means a clinical study or research study initiated and conducted by an individual not employed by or on the behalf of a Party.




		
	1.73.
	“Ivory” means Amgen’s proprietary antibody, denosumab.




		
	1.74.
	“Ivory  Intellectual  Property”  means  any  Invention,  Know-How,  Patents,    Product Trademark, trademark application, electronic media registrations (including domain names, usernames, websites, blogs and the like), or Copyright owned or controlled by Amgen or its Affiliates that is related to Ivory in the Collaboration Scope.




		
	1.75.
	“Ivory Net Revenues” means:  (i) the aggregate of the gross invoiced sales prices for Ivory that is sold or transferred for value by Amgen or its Affiliates to Third Parties in the Collaboration Territory and used in the Collaboration Scope, minus the following amounts incurred or paid (each as recognized by GAAP and each to the extent not already deducted when calculating COGS) by Amgen or its Affiliates with respect to



14










such sales or transfers for value (regardless of the period in which such amounts are incurred or paid):


		
	1.75.1.
	trade, cash, prompt payment and/or quantity discounts;




		
	1.75.2.
	payments to government agencies, returns, refunds, allowances, rebates and chargebacks;




		
	1.75.3.
	retroactive price reductions applicable to sales of Ivory;




		
	1.75.4.
	fees  paid  to  distributors,  wholesalers,  selling  agents  (excluding  any  sales representatives   of   a   Party   or   any   of   its   Affiliates),   group   purchasing organizations and managed care entities;




		
	1.75.5.
	the standard inventory cost (actual acquisition or manufacture cost) of devices used for dispensing or administering Ivory which are shipped with the Ivory and included in the gross invoiced sales prices;




		
	1.75.6.
	credits or allowances for product replacement, whether cash or trade;




		
	1.75.7.
	any  tax,  tariff,  duty  or  governmental  charge  levied  on  the  sales,  transfer, transportation or delivery of Ivory (including any tax such as a value added or similar tax or government charge), other than franchise or income tax of any kind whatsoever;




		
	1.75.8.
	the actual amount of write-offs for bad debt (if tracked) or, if untracked, a two percent (2%) allowance for bad debt;




		
	1.75.9.
	insurance, shipping and freight costs directly related to the delivery of Ivory and special packaging (if tracked) or, if one or more of the foregoing are untracked, the greater of the sum of the tracked items and a one percent (1%) allowance; and




		
	1.75.10
	any import or export duties or their equivalent borne by the relevant seller;




plus (ii) any Recoveries made pursuant to Section 9.8 (Enforcement).


		
	1.76.
	“Ivory Patent and Trademarks” has the meaning set forth in Section 9.6 (Prosecution and Maintenance).




		
	1.77.
	“Joint Brand Team” or “JBT” means the joint brand team established pursuant to Article 2 (Scope and Governance).




		
	1.78.
	“Joint Claim” has the meaning set forth in Section 13.5 (Defense of Third Party Claims).




		
	1.79.
	“Joint  Development  Committee”  or  “JDC”  means  the  development  committee established pursuant to Article 2 (Scope and Governance).




		
	1.80.
	“Joint Invention” has the meaning set forth in Section 9.1 (Invention Ownership).




		
	1.81.
	“Joint  Steering  Committee”  or  “JSC”  means  the  steering  committee  established pursuant to Article 2 (Scope and Governance).




		
	1.82.
	“Judicial Force Majeure” has the meaning set forth in Section 16.9 (Force Majeure).



15










		
	1.83.
	“Know-How” means all tangible and intangible techniques, information, technology, practices, trade secrets, Inventions (whether patentable or not), methods, processes, knowledge, know-how, conclusions, skill, experience, test data and results (including pharmacological, toxicological, manufacturing, and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms, including works of authorship and Copyrights.  Know-How does not include Patents.




		
	1.84.
	“Other Detail” means any Detail other than a First Position Detail or a Second Position Detail.




		
	1.85.
	“Party” or “Parties” has the meaning set forth in the Preamble.




		
	1.86.
	“Patent  Coordinator”  means  those  employees  of  each  of  the  Parties  appointed pursuant to Section 2.14 (Patent Coordinators) to serve as each such Party’s primary liaison with the other Party on matters relating to intellectual property as described in this Agreement.




		
	1.87.
	“Patents”  means  the  issued  patents  and  pending  patent  applications  (including certificates of invention, applications for certificates of invention and priority rights) in any country or region, including all provisional applications, refilings, substitutions, continuations, continuations-in-part, divisions, renewals, all letters patent granted thereon, and all reissues, re-examinations and patent term extensions thereof, and all international or foreign counterparts of any of the foregoing (including supplemental protection certificates, patents of addition and the like).




		
	1.88.
	“Person”  means  an  individual,  corporation,  partnership,  limited  liability  company, trust, business trust, association, joint stock company, joint venture, pool, syndicate, “group” as defined in Section 13(d)(3) of the Exchange Act, sole proprietorship, unincorporated organization, Governmental Authority or any other form of entity not specifically listed herein.




		
	1.89.
	“Phase IV Trial” means any clinical study initiated in the Collaboration Territory following the first Regulatory Approval for Ivory in the Collaboration Scope for the indication being studied.   Phase IV Trials may include epidemiological studies, modeling and pharmacoeconomic studies, ISS and post-marketing surveillance studies.




		
	1.90.
	“Product Trademarks” means the trademark “ProliaTM,” any other related trademark, trade name or service mark (whether registered or unregistered) containing the word “ProliaTM,” and any other trademark, trade name or service mark (whether registered or unregistered) selected by the JBT for use on, with, or to refer to Ivory (other than Amgen  Housemarks  and  GSK  Housemarks,  as  applicable)  in  the  Collaboration Territory during the Term, and all intellectual property rights residing in the foregoing.




		
	1.91.
	“Promotional  Materials”  has  the  meaning  set  forth  in  Section  3.10  (Promotional Materials).




		
	1.92.
	“Prosecution  and  Maintenance”  means  the  preparation,  filing,  and  prosecution  of patent applications and maintenance of patents, as well as re-examinations and reissues with respect to such patents, together with the conduct of interferences and the defense of oppositions with respect to such patent application or patent; and “Prosecute and Maintain” has the correlative meaning.



16










		
	1.93.
	“Qualified Amgen R&D Costs” means those costs incurred by or on behalf of Amgen or its Affiliates in connection with research and development of Ivory useful to the Collaboration Scope, but excluding: (i) Collaboration Territory R&D Costs; and (ii) any costs applicable to the research and development of Ivory for the sole benefit of one (1) or more countries or regions in the Excluded Territory or Expansion Territory and not useful in the Collaboration Scope.  “Qualified Amgen R&D Costs” will include the costs of all of Amgen’s internal FTEs that are involved in the conduct of development of Ivory in the Collaboration Field, regardless of whether directed to the Collaboration Territory or countries outside the Collaboration Territory (including the Expansion  Territory  and/or  the  Excluded  Territory).  Such  FTE  costs  will  not  be included in Collaboration Territory R&D Costs.




		
	1.94.
	“Recoveries” means all monies received by Amgen from a Third Party in connection with the final, non-appealable judgment (or judgment with respect to which the time period for appeal has expired), award or settlement of any enforcement with respect to any  Ivory  Intellectual  Property,  to  the  extent  such  judgment,  award  or  settlement pertains to activities within the Collaboration Scope.




		
	1.95.
	“Regulatory  Approval”  means  a  product-specific  approval  from  a  Governmental Authority necessary for the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of Ivory.




		
	1.96.
	“Regulatory Filing” means any filing with any Governmental Authority with respect to the research, development manufacture, distribution, pricing, reimbursement, marketing or sale of Ivory.




		
	1.97.
	“Remediation Plan” has the meaning set forth in Section 14.2.2.




		
	1.98.
	“Roche  Agreement”  means  the  Amended  and  Restated  Co-Promotion  Agreement between Hoffmann-La Roche Inc. and F. Hoffmann-La Roche Ltd. (collectively, “Roche”) and GSK dated December 6, 2001, as amended from time to time, pursuant to which GSK and Roche are commercializing BonvivaTM in certain countries of the world and BonivaTM in the United States of America (such product, “BonvivaTM” and such program, the “BonvivaTM program”).




		
	1.99.
	“Roche Claim” means any claim made by Roche arising out of or in connection with the  Roche  Agreement  or  GSK’s  performance  or  failure  to  perform  thereunder,  or actions or omissions by GSK or any of its Affiliates with respect to the Roche Agreement,  including  any  claims  of  interference  with  contractual  relations  or prospective economic advantage (or analogous claim under the law of any jurisdiction) based on any action or omission of Amgen or GSK in connection with this Agreement or the transactions or activities contemplated hereby.




		
	1.100.
	“Routine Audit” has the meaning set forth in Section 3.14.4 (Manufacturing).




		
	1.101.
	“Rules” has the meaning set forth in Section 16.2 (Arbitration).




		
	1.102.
	“Sales Forecast” means the sales forecast set forth in the Sales Forecast Schedule.




		
	1.103.
	“Samples” has the meaning set forth in Section 3.13 (Samples).




		
	1.104.
	“Second  Position  Detail”  means  a  Detail  in  which  the  applicable  pharmaceutical product is Detailed in the second position (i.e., no more than one (1) other product is





17










presented to or discussed with the healthcare professional before Ivory) and the second most predominant portion of time is devoted to the Detailing of such pharmaceutical product.


		
	1.105.
	“Segregate” means, with respect to two (2) programs: (i) to restrict and prevent all program-related contacts and communications between personnel (whether employees, consultants, Third Party contractors or otherwise and whether or not located within the Collaboration Territory (for the purposes of this Section 1.105, “Personnel”)) working on or involved with the development or commercialization of the first program and Personnel working on or involved with the development or commercialization of the second program; (ii) to ensure that Personnel that are working on the first program will not simultaneously work on the second program and vice versa; (iii) to ensure that confidential information relating to the first program is not shared with or accessed by Personnel that are working on the second program and vice versa; and (iv)  from time- to-time,  upon  the  reasonable  request  of  the  other  Party,  to  provide  information requested relating to the foregoing items (i) through (iii), and to reasonably cooperate to enable the other Party to verify that such restrictions are in place and sufficient to achieve  the  foregoing.     For  clarity,  the  foregoing  restrictions  will  not  prevent employees of GSK that are general managers of one (1) or more countries in the Collaboration Territory or that are at or above the senior vice president level from providing high-level oversight of both programs, provided that such employees do not have day-to-day responsibilities for either program and that GSK ensures such employees understand and comply with their obligations of confidentiality and non-use as set forth herein.




		
	1.106.
	“Special Meeting” has the meaning set forth in Section 14.2.2.




		
	1.107.
	“Standard Costs” means, with respect to a Collaboration SKU, standard cost for the Inventory  Layer  from  which  such  Collaboration  SKU  was  taken,  as  reflected  in Amgen’s  accounting  records  at  the  time  such  Collaboration  SKU  is  sold.    Such Standard Cost, calculated annually for the period commencing January 1 and ending December 31 of the same year, is the sum of estimated Direct and Indirect Costs for Ivory produced as of such date of sale.




		
	1.108.
	“Tail Payment” has the meaning set forth in Section 14.11 (Tail Payments).




		
	1.109.
	“Tail Period” means that period commencing January 1, 2023 and ending December 31, 2024.




		
	1.110.
	“Taxes” means any tax, excise or duty, other than taxes upon income.




		
	1.111.
	“Term”  means  the  period  commencing  on  the  Effective  Date  and  ending  upon December 31, 2022, unless and until sooner terminated pursuant to any provision of this Agreement.




		
	1.112.
	“Third Party” means any Person that is not a Party, or an Affiliate of a Party.




		
	1.113.
	“Third Party Claim” means any claim, action, lawsuit, or other proceeding brought by any Third Party.  Third Party Claim includes any Roche Claim and any Infringement Claim.



18










		
	1.114.
	“VAT” means the tax imposed by Council Directive 2006/112/EC of the European Community and any national legislation implementing that directive together with legislation supplemental thereto and in particular, in relation to the United Kingdom, the tax imposed by the Value Added Tax Act of 1994 or other tax of a similar nature imposed in other countries in the Collaboration Territory instead of or in addition to value added tax.




		
	1.115.
	“Voting Securities” means securities entitled to be voted generally or in the election of directors of a Person.




		
	2.
	SCOPE AND GOVERNANCE




		
	2.1.
	Purpose of the Collaboration.   The purpose of the collaboration is for the Parties to collaborate in the com    mercialization of Ivory in the Collaboration Scope and for the Parties to share in certain costs and revenues related to Ivory, all as described in more detail herein.




		
	2.2.
	Co-Exclusive Appointment.   Subject to the terms and conditions of this Agreement, Amgen hereby retains GSK on a co-exclusive basis with Amgen to Detail Ivory in the Collaboration Scope and to conduct the Designated GSK Activities.




		
	2.3.
	Governance.    With  respect  to  the  Collaboration  Scope,  the  collaboration  will  be governed by: (i) the CRC, which will be responsible for the resolution of issues within the collaboration that cannot be resolved by the JSC; (ii) the JSC, which will be responsible for oversight of the collaboration; (iii) the JBT, which will be responsible for developing the Brand Plan for Ivory within the Collaboration Scope; (iv) a Country Team  for  each  country  within  the  Collaboration  Territory  (provided  that  one  (1) Country Team may oversee more than one (1) country (e.g., Benelux countries)); (v) the  JDC,  which  will  be  responsible  for  establishing  the  Development  Plan  and discussing the activities to be conducted thereunder; and (vi) the Patent Coordinators responsible for intellectual property issues as set forth herein.  All such committees and teams  (the  terms  committee  and  team  being  used  interchangeably  herein)  will  be formed promptly following the Effective Date.   Each such committee and team will oversee the activities undertaken by the Parties in the Collaboration Scope within the scope of authority of such committee or team, including monitoring progress against plans and outlining how Parties will collaborate in the conduct of such activities.  It is expected that the committees and teams will develop plans and strategies assigned to it in a collaborative manner and will serve as a forum for discussion of and input into such plans and strategies.




		
	2.4.
	Decision Making Standards.    The decisions made and actions taken by the CRC, JSC, JBT, JDC, Country Teams and Patent Coordinators will be made with the interests of both Parties (including the Parties’ interests in the collaboration) (as presented to such committee or team) duly considered in good faith.   Subject to the terms of this Agreement and Applicable Law, the decisions of such teams and committees will be made in accordance with the discretion and business judgment of the members thereof.




		
	2.5.
	Membership.  Each of the JSC, JBT and JDC will be comprised of three (3) members appointed by Amgen, and three (3) members appointed by GSK (or such other number of members as agreed in writing by the Parties).  The JSC, JBT and JDC will each be



19










led by two (2) co-chairs, one (1) appointed by each of the Parties.  Each Country Team will be comprised of four (4) members appointed by Amgen, and four (4) members appointed by GSK (or other number of members as agreed in writing by the Parties). The CRC will be comprised of one (1) member appointed by each of the Parties, and such members initially will be the President of Pharmaceuticals, Europe (or his or her designee) for GSK and Executive Vice-President, Global Commercial Operations (or his or her designee) for Amgen.  Each Party will ensure that the committee members appointed by it have the appropriate level of seniority and decision-making authority commensurate with the responsibilities of the committee to which they are appointed.


		
	2.6.
	Replacement of Members.   Each Party will have the right to replace its committee members by written notice to the other Party.   In the event any committee member becomes unwilling or unable to fulfill his or her duties hereunder, the Party that appointed such member will promptly appoint a replacement by written notice to the other Party.




		
	2.7.
	Establishment of Subcommittees.   Each committee will have the right to establish subcommittees or working teams with respect to issues within its area of responsibility as it sees fit (e.g., pricing, manufacturing or operations).  Each Country Team will have the right to establish a local operations team to facilitate the performance of its responsibilities.




		
	2.8.
	No Authority to Amend or Modify.  Notwithstanding anything herein to the contrary, no committee will have any authority to amend, modify or waive compliance with this Agreement.




		
	2.9.
	Collaboration Review Committee.   The CRC will be responsible for resolving any issues within the collaboration that cannot be resolved by the JSC.




		
	2.9.1.
	Meetings.  The CRC will meet as requested by the JSC to resolve unresolved issues, via teleconference or videoconference or as otherwise agreed by the Parties.   Each Party will be responsible for its own expenses relating to such meetings.   As appropriate, other employee representatives of the Parties may attend CRC meetings as nonvoting participants, but no Third Party personnel may attend unless otherwise agreed by the Parties.   All CRC meetings must have all members in attendance.




		
	2.9.2.
	Decision Making.  The CRC will make decisions by consensus with each Party having one vote.  In the event of a deadlock the decision will be made by the member appointed to the CRC by Amgen.




		
	2.10.
	Joint Steering Committee.  The JSC will be responsible for overseeing the collaboration, including the commercialization of Ivory in the Collaboration Scope generally.   The JSC will be a forum for: (i) discussing commercialization strategy; (ii) approving the Brand Plan established by the JBT; (iii) reviewing the allocation of operational responsibility between the Parties set forth in the Country Plans; (iv) allocating operational responsibility between the Parties for activities that are applicable to the Collaboration Scope as a whole (i.e. that are not country-specific); (v) developing and updating a rolling three (3) year Sales Forecast and supply forecast; (vi) developing and updating the expense budget (expressed in U.S. Dollars, unless otherwise agreed by the





20










Parties) for commercialization activities to be undertaken pursuant to the collaboration based  upon  the  Brand  Plan  and  Country  Plans  (the  “Collaboration  Budget”); (vii) reviewing and approving the draft pricing and access plan proposed by the JBT; (viii) reviewing the Standard Costs of Ivory on an annual basis and additionally if and when the Standard Costs exceed, or are expected to exceed, the expected Standard Costs by ten percent (10%) or more; (ix) discussing sourcing matters related to the manufacture of Ivory, including: (a) to what extent Third Parties will be used to manufacture Ivory for the Collaboration Scope and any material changes to the arrangement with such Third Party manufacturer(s) in advance of implementation of such changes; and (b) methodology of allocating Inventory Layers to the Collaboration Scope; (x) discussing adequacy of supply of Ivory for the Collaboration Scope in connection with then-current forecasts and any occurrence that may require a For Cause Audit as provided in Section 3.14.4 (Manufacturing), (xi) agreeing to an amended FTE Rate  Schedule,  and  (xii)  discussing  regulatory matters.    The  JSC  will  conduct  its activities in consultation and/or cooperation with the JDC with respect to those matters that such committees determine appropriate, including regulatory matters and the usefulness of development to the commercial potential of Ivory in the Collaboration Scope.


		
	2.10.1.
	Meetings.  The JSC will meet quarterly, via teleconference or videoconference or otherwise (with at least two (2) meetings per calendar year being in person), or as otherwise agreed by the Parties.  Any in-person meetings will be held on an  alternating  basis  between  GSK’s  and  Amgen’s  European  headquarters, unless otherwise agreed by the Parties.  Each Party will be responsible for its own expenses relating to such meetings.   As appropriate, other employee representatives of the Parties may attend JSC meetings as nonvoting participants, but no Third Party personnel may attend unless otherwise agreed by the Parties. Each Party may also call for special meetings of the JSC as reasonably required to  resolve  particular  matters  requested  by  such  Party  by  at  least  ten  (10) business days prior written notice to the co-chair appointed by the other Party. All JSC meetings must have at least one (1) member appointed by each Party in attendance.




		
	2.10.2.
	Reporting.    Each  Party  will  keep  the  JSC  fully  and  promptly  informed  of progress and results of activities in the Collaboration Scope for which it is responsible or that it is permitted to conduct hereunder through its members on the JSC and as otherwise provided herein.  Each Party will fully inform the JSC with respect to its activities in the Collaboration Scope undertaken pursuant to this    Agreement    as    reasonably    requested    by    any    member    thereof. Notwithstanding the foregoing, Amgen will have no obligation to provide proprietary manufacturing information to GSK through any committee or otherwise.




		
	2.10.3.
	Decision Making.  The JSC will make decisions by consensus with each Party having one vote.  In the event of a deadlock on an issue, the decision will made by the members of the JSC appointed by Amgen, provided that the members appointed by either Party will have the right to require that such issue be escalated to the CRC for determination.  Notwithstanding the foregoing, in the



21










event of a decision on any matter that requires exigent action pursuant to Applicable Law or to prevent a material adverse effect on Ivory or a Party, the members of the JSC appointed by Amgen will have the right to make an interim decision pending CRC determination.


		
	2.11.
	Joint Brand Team.  The JBT will be responsible for developing specified plans and overseeing specified commercial activities relating to Ivory in the Collaboration Scope generally.  The JBT will be a forum for discussing, developing, and agreeing upon the Brand Plan for submission to the JSC for approval.  The JBT’s responsibilities will include: (i) cross-functional, collaborative development and updating of the Brand Plan including strategies and tactics at the regional level; (ii) consolidation of expense and Sales Forecasts from the country level; (iii) developing and updating a draft pricing and access plan for JSC approval; (iv) tactical alignment of commercialization activities with expense budget allocations; and (v) core message element development, updating and communication to the Country Teams.   The JBT will conduct its activities in consultation and/or cooperation with the Country Teams with respect to those matters that such teams determine appropriate.




		
	2.11.1.
	Meetings.  The JBT will meet monthly, via teleconference or videoconference or otherwise (with at least four (4) meetings per calendar year being in person), or as otherwise agreed by the Parties.  Any in-person meetings will be held on an  alternating  basis  between  GSK’s  and  Amgen’s  European  headquarters, unless otherwise agreed by the Parties.  Each Party will be responsible for its own expenses relating to such meetings.   As appropriate, other employee representatives   of   the   Parties   may   attend   JBT   meetings   as   nonvoting participants, but no Third Party personnel may attend unless otherwise agreed by the Parties.   Each Party may also call for special meetings of the JBT as reasonably required to resolve particular matters requested by such Party by at least ten (10) business days prior written notice to the co-chair appointed by the other Party.  All JBT meetings must have at least one (1) member appointed by each Party in attendance.




		
	2.11.2.
	Reporting.    Each  Party  will  keep  the  JBT  fully  and  promptly  informed  of progress and results of activities in the Collaboration Scope for which it is responsible or that it is permitted to conduct hereunder through its members on the JBT and as otherwise provided herein.  Each Party will fully inform the JBT with respect to its activities in the Collaboration Scope undertaken pursuant to this Agreement as reasonably requested by any member thereof.




		
	2.11.3.
	Decision Making.  The JBT will make decisions by consensus with each Party having one vote.  In the event of a deadlock, the decision will be made by the members of the JBT appointed by Amgen, provided that the members appointed by either Party will have the right to require that such issue be escalated to the JSC for determination.   In the event of a decision on a matter that requires exigent action pursuant to Applicable Law or to prevent a material adverse effect on Ivory or a Party, the members of the JBT appointed by Amgen will have the right to make an interim decision pending JSC determination.



22










		
	2.12.
	Joint  Development  Committee.     The  JDC  will  be  responsible  for  updating  the Development  Plan  and  the  Development  Budget,  reviewing  clinical  protocols  for studies to be conducted under the Development Plan, and overseeing the conduct and progress of the activities set forth in the Development Plan including regulatory matters. In addition to the foregoing, the JDC will discuss development to be undertaken by Amgen outside the Collaboration Scope to the extent either Party reasonably believes such development is reasonably likely to have a material adverse effect on Ivory within the Collaboration Scope (and Amgen will provide summary information of Ivory development to be undertaken by Amgen outside the Collaboration Scope in order to enable GSK to make such determination).   The JDC will conduct its activities in consultation and/or cooperation with the JSC with respect to those matters as such committees determine appropriate, including regulatory matters and the usefulness of development to the commercial potential of Ivory in the Collaboration Scope.




		
	2.12.1.
	Meetings.  The JDC will meet quarterly, via teleconference or videoconference or otherwise (with at least one (1) meeting per calendar year being in person), or as otherwise agreed by the Parties.  Any in-person meetings will be held on an alternating basis between GSK’s and Amgen’s European or global headquarters, unless otherwise agreed by the Parties.  Each Party will be responsible for its own expenses relating to such meetings.   As appropriate, other employee representatives of the Parties may attend JDC meetings, but no Third Party personnel may attend unless otherwise agreed by the Parties.  Each Party may also call for special meetings of the JDC as reasonably required to discuss particular matters requested by such Party by at least ten (10) business days prior written notice to the co-chair appointed by the other Party.   All JDC meetings must have a member appointed by each Party in attendance.




		
	2.12.2.
	Reporting.   Each Party will keep the JDC fully and promptly informed of progress and results of activities in the Collaboration Scope for which it is responsible or that it is permitted to conduct hereunder through its members on the JDC and as otherwise provided herein.   Each Party will fully inform the JDC  with  respect  to  its  activities  in  the  Collaboration  Scope  undertaken pursuant to this Agreement as reasonably requested by any member thereof.




		
	2.12.3.
	Decision Making.  The JDC will make decisions by consensus with each Party having one vote.  In the event of a deadlock, the decision will be made by the members  of  the  JDC  appointed  by  Amgen,  provided  that  the  members appointed by either Party will have the right to escalate to the CRC for determination decisions that: (i) involve a safety issue; (ii) are likely to have a material impact on the Development Budget; or (iii) involve development that is likely to have a material adverse effect on commercialization of Ivory in the Collaboration Scope, in each case, in the reasonable opinion of the escalating Party.    In the event of a decision on a matter that requires exigent action pursuant to Applicable Law or to prevent a material adverse effect on Ivory or a Party, the members of the JDC appointed by Amgen will have the right to make an interim decision pending CRC determination.




		
	2.13.
	Country Teams.  Country Teams will be responsible for localizing and implementing marketing strategy and brand planning, allocation of sales representatives, coordination



23










of primary and specialty care sales representatives, determination of Detail frequency and weighting, determination of customer targets, planning sales implementation meetings, review of local sales performance metrics and market research, review of local forecasts for revenue and expenses and review of local access and reimbursement matters, in each case for the relevant country or countries.  All such matters will be in accordance with the Brand Plan.  The Country Teams will conduct their activities in consultation and/or cooperation with the JBT with respect to those matters that such teams determine appropriate.


		
	2.13.1.
	Meetings.  Each Country Team will meet six (6) times per year, or as otherwise agreed by the Parties.  Meetings will be held on an alternating basis between GSK’s and Amgen’s headquarters for the relevant country, unless otherwise agreed by the Parties.   Each Party will be responsible for its own expenses relating to such meetings.  As appropriate, other employee representatives of the Parties may attend Country Team meetings as nonvoting participants, but no Third Party personnel may attend unless otherwise agreed by the Parties.  Each Party may also call for special meetings of a Country Team as reasonably required to resolve particular matters requested by such Party by at least ten (10) business days prior written notice to the designated member appointed by the other Party.  All Country Team meetings must have at least one (1) member appointed by each Party in attendance.  At the request of the JBT, each Country Team will attend international brand strategy and/or communications summits.




		
	2.13.2.
	Reporting.    Each  Party  will  keep  each  Country  Team  fully  and  promptly informed of progress and results of activities in the relevant region for which it is responsible or that it is permitted to conduct hereunder through its members on the relevant Country Team and as otherwise provided herein.   Each Party will fully inform each Country Team with respect to its activities in the Collaboration Scope undertaken pursuant to this Agreement as reasonably requested by any member thereof.




		
	2.13.3.
	Decision Making.  Each Country Team will make decisions by consensus.  In the event of a deadlock, the decision will be made by the members of the relevant Country Team appointed by Amgen, provided that the members appointed by either Party will have the right to require that such issue be escalated to the JSC for determination.  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 JSC determination.




		
	2.14.
	Patent Coordinators.  The Parties will each appoint a Patent Coordinator promptly after the Effective Date of the Agreement.  The Patent Coordinators will serve as the primary contacts and forum for discussion between the Parties with respect to intellectual property matters involving Ivory worldwide in the Collaboration Field, and will cooperate with respect to the activities set forth in Article 9 (Intellectual Property).  A strategy will be discussed with regard to Prosecution and Maintenance, defense and enforcement of Ivory Intellectual Property, defense against allegations of infringement of Third Party Patents, and licenses to Third Party Patents or Know-How (including





24








obtaining Third Party licenses within the Collaboration Scope in response to allegations of infringement of such Third Party Patents or Know-How), and any material change to any license to Third Party Patents or Know-How in existence as of the Effective Date, in each case within the Collaboration Scope or outside the Collaboration Scope to the extent such matter would be reasonably likely to have a material impact on the Collaboration Scope.   The Patent Coordinators will meet as often as agreed by them (and at least semi-annually if requested), via teleconference or videoconference or as otherwise agreed, to discuss matters arising out of the activities set forth in Article 9 (Intellectual Property).  To the extent reasonably requested by either Patent Coordinator, the Patent Coordinators will solicit the involvement of more senior members of their respective legal departments (up to the most senior intellectual property attorney, where appropriate) with respect to critical issues, and may escalate issues to the JSC for input. Each of the Patent Coordinators will consider comments and suggestions made by the other in good faith.   Notwithstanding anything in this Agreement to the contrary, neither Patent Coordinator will have the obligation to disclose information to the extent prohibited by obligation of confidentiality or protective order, that would result in loss of attorney-client or other relevant legal privilege, that constitutes proprietary manufacturing information or where the other Party has an actual or potential conflict of interest with respect to such information (e.g., where sharing such information would be reasonably likely to provide the recipient with a commercial advantage with respect to a product competitive to Ivory that is being developed or commercialized by such Party).


		
	2.15.
	Alliance Managers.  Promptly after the Effective Date, each Party will appoint a person who will oversee interactions between the Parties between meetings of the committees and teams established hereunder (each, an “Alliance Manager”).   Unless otherwise agreed by the Parties, the Alliance Managers will attend all meetings of the JSC and will have the right to attend all meetings of the JDC and JBT, as non-voting participants at such meetings.  Each Party may replace its Alliance Manager at any time by notice in writing to the other Party.




		
	2.16.
	Territorial Expansion.  Any country that accedes to the European Union (other than a country in the Excluded Territory) after the Effective Date will become part of the Collaboration  Territory  and  incorporated  in  the  collaboration.     The  Parties  will cooperate to ensure a smooth and orderly transition of such country into the collaboration and avoid any action reasonably likely to have a material adverse effect on Ivory.  If GSK is the holder of any Regulatory Filings in such country, GSK will transfer to Amgen ownership of, or if such transfer is not possible or until such transfer occurs, provide Amgen a right of reference and right of access to, any Regulatory Filings related to Ivory in the applicable country as requested by Amgen.  Amgen will have the right to instruct GSK to abandon any Regulatory Filing in the Collaboration Territory for Ivory, and GSK will promptly do so if so instructed.  If a country accedes to  the  European  Union  and  is  incorporated into  the  collaboration  pursuant  to  this Section 2.16 (Territorial Expansion), Ivory Net Revenues from sales of Ivory in such country will not be included within Ivory Net Revenues for the purpose of calculating the Inventorship Margin, but will be included in Ivory Net Revenues for all other purposes hereunder.



25








		
	2.17.
	Internal  Governance.    The  Parties  acknowledge  that  the  committee  and  decision- making structure set forth herein is without prejudice to, and does not supplant, the Parties’ internal decision-making structures.




		
	3.
	COLLABORATION ACTIVITIES – ALLOCATION AND REPORTING




		
	3.1.
	Allocation of Operational Responsibility.  The JSC will be responsible for allocating non-country-specific commercial activities within the Collaboration Scope to Amgen and/or  GSK  and  for  determining  whether  operational  responsibility  for  any  such activity should be transferred from GSK to Amgen or vice versa.  The Country Teams will be responsible for allocating country-specific commercial activities within the Collaboration  Scope  to  Amgen  and/or  GSK  in  the  applicable  country  or  region overseen    by   such   Country   Team,   and   for   determining   whether   operational responsibility for any such activity should be transferred from GSK to Amgen or vice versa.    The Country Teams will keep the JSC informed of the initial allocation of country-specific activities and transfers thereof between the Parties.  Unless and until determined otherwise by the JSC or the relevant Country Team in accordance with the foregoing, the Parties’ initial commercial responsibilities will be as set forth in the Country Plans referenced in Section 3.2 (Country Plans), and in Sections 3.3 (Designated GSK Activities) and 3.4 (Designated Amgen Activities).




		
	3.2.
	Country Plans.  Allocations of commercial operational responsibility for countries and regions within the Collaboration Scope will be set forth in country plans developed by the relevant Country Team (as such plans may be updated or modified from time-to- time by the relevant Country Team and approved by the JSC), the “Country Plans”). Country Plans will be developed by the relevant Country Team promptly upon request by the JBT, taking into account the planned launch timing for the relevant country.




		
	3.3.
	Designated GSK Activities.  GSK will be responsible for providing primary care sales representatives for Detailing Ivory within the Collaboration Scope in accordance with the Brand Plan, and conducting other activities assigned to the GSK by the JSC (with respect to non-country-specific activities) or the relevant Country Team (with respect to country-specific activities).




		
	3.4.
	Designated Amgen Activities.   Amgen will have operational responsibility to perform itself or through its designee (subject to Section 4.5 (use of Affiliates and Third Party Contractors)), all activities related to the commercialization of Ivory within the Collaboration Scope (including sales, pricing, access, coverage (including risk sharing arrangements and any health technology assessment submissions), reimbursement, presentation, ancillary items or devices, contracting, launch timing, distribution, marketing messaging, product positioning, development of training materials, sales tracking and auditing, market research and product usage surveys, provision of medical affairs support staff, scientific and medical advisory boards (including any global medical conferences regardless of whether such conferences are within or outside the Collaboration Territory) and provision of specialty care sales representatives), except for activities that are assigned to GSK by the JSC pursuant to Section 3.1 (Allocation of Operational Responsibility), assigned to GSK in the Country Plans pursuant to Section 3.2 (Country Plans) or activities that are Designated GSK Activities pursuant to Section


3.3 (Designated GSK Activities).

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	3.5.
	Collaboration   in   Commercialization   Activities.      The   allocation   of   operational responsibility for commercialization activities hereunder as well as the conduct of such activities by the Parties will be subject to comprehensive discussion by the JSC, JBT and Country Teams, as applicable, where each Party will consider the input of the other with respect to the conduct of such activities.   The commercial activities will be allocated on a country-specific and non-country specific basis by such committees and/or teams taking into consideration all relevant factors, including the capabilities of each Party to deliver the highest quality product in the most cost-effective manner, without duplication of efforts between the Parties. Each of the JBT and Country Teams, as applicable, will endeavor to meet the goals of the Brand Plan and Country Plans within the parameters of the Collaboration Budget established by the JSC.




		
	3.6.
	Amgen Participation Increase and Transition.




		
	3.6.1.
	Participation Increase.   Commencing January 1, 2016, Amgen will have the right, but not the obligation, to contribute up to fifty percent (50%) of the minimum number of full-time primary care sales representatives for Detailing Ivory in one (1) or more countries in the Collaboration Territory.  Amgen will provide written notice to GSK via the JSC at least six (6) months prior to the date on which Amgen desires to increase its participation, such notice to set forth the level of Amgen’s participation and the country or countries of the Collaboration Territory in which Amgen will participate.  The Country Teams will be responsible for amending the Country Plans to provide for such reallocation of resources, which will be subject to review by the JSC.




		
	3.6.2.
	Potential Quid.  No later than six (6) months from the Effective Date, GSK will discuss with Amgen the potential for Amgen’s sales force to promote one (1) or more of GSK’s products on terms mutually acceptable to the Parties.   If the Parties fail to agree on an arrangement for Amgen to promote such product(s), then GSK will consider in good faith engaging in discussions with Amgen, from time-to-time, if additional product quid opportunities become available.  For the avoidance of doubt, nothing herein obligates Amgen to promote, or obligates GSK to engage Amgen to promote one (1) or more of GSK’s products, and any such agreement must be in a writing duly executed by each of the Parties.




		
	3.7.
	All Sales by Amgen.  This Agreement does not authorize GSK, its Affiliates or their respective agents or employees to sell Ivory.   Amgen will have the sole right, in Amgen’s discretion, to price Ivory (including with respect to trade, quantity or other discounts), determine the launch conditions and terms of sale for Ivory, take orders for and returns of Ivory, issue credits for Ivory, sell Ivory and book sales thereof and GSK will have no rights with respect to Ivory outside the Collaboration Scope.  GSK will promptly forward to Amgen all orders for, and requests to order, Ivory.  Amgen will have the right to refuse or cancel any order for Ivory without liability to GSK.  GSK will not interfere with any agreement of Amgen or any of its Affiliates related to Ivory, including pricing and contracting for the sale of Ivory.




		
	3.8.
	Training.  The  Parties  will  jointly  (except  where  impracticable)  train  the  sales representatives hereunder with respect to the promotion of Ivory in the Collaboration Scope  (and  update  such  training  from  time  to  time  as  appropriate);  (including



27










compliance training as determined by the JBT).   The JBT will be responsible for developing the Ivory training programs and materials for the sales forces of Amgen and GSK with respect to Ivory in the Collaboration Scope.  Training of the Parties’ sales forces will be conducted using only training materials and programs developed by the JBT.  Amgen will own all right, title and interest in the training materials developed hereunder (except with respect to any GSK Housemarks contained therein).


		
	3.9.
	Information Concerning Ivory.




		
	3.9.1.
	Public Statements.  GSK will ensure that no claims or representations in respect of Ivory or the characteristics thereof are made by or on behalf of it or its Affiliates (by sales force members or otherwise) that have not been approved by Amgen and neither Party will make any claim or representation that does not represent an accurate summary or explanation of the labeling of Ivory.




		
	3.9.2.
	Ownership.    GSK  will  not  represent  to  any  Third  Party  that  it  has  any proprietary or property right or interest in Ivory (or the Product Trademarks or any Patents claiming or covering Ivory or its manufacture, use or sale), except for the rights expressly granted to GSK hereunder.   Furthermore, GSK acknowledges that it does not have any right, title or interest in Ivory or the Product Trademarks.




		
	3.10.
	Promotional Materials.  All written sales, promotion and advertising materials relating to  Ivory  (collectively  “Promotional  Materials”)  (including  translations)  will  be produced by Amgen in accordance with the Brand Plan developed by the JBT and reviewed and approved by the JSC.   Any Promotional Materials will include, if permitted by Applicable Law, the Amgen Housemarks and the GSK Housemarks (provided, however, that Amgen will be entitled a reasonable transition period after any required legal approval is obtained to design, order, receive and implement Promotional Materials revised to include the GSK Housemarks).   Materials that include the GSK Housemarks will use such GSK Housemarks in accordance with any reasonable usage guidelines provided by GSK, and any usage not conforming with such guidelines will require GSK’s prior approval as to the use of such GSK Housemarks.   GSK will respond to any such requests for approval within ten (10) business days.  In the absence of such response within such period, the request will be deemed approved.   Unless otherwise determined by the JSC, Amgen will be responsible for the printing and delivery to GSK of Promotional Materials for use in GSK’s Detailing obligations hereunder, and costs therefor will be included as Amgen Costs for purposes of Collaboration Profit (Loss).   Other than GSK’s use and distribution of Promotional Materials that are approved by the JSC and used and distributed in connection with GSK’s Detailing of Ivory within the Collaboration Scope, GSK will not produce or modify (other than as concepts for consideration by Amgen), or distribute or otherwise use any promotional or communications material relating to Ivory.  If so instructed by Amgen, GSK will immediately cease to use any Promotional Materials and will collect and destroy any such materials from its sales representatives (and record and document such collection and destruction (and provide a copy of such documentation to Amgen upon request)).   Amgen will own all right, title and interest in and to any and all Promotional Materials including applicable Copyrights and trademarks (except with respect to any GSK Housemarks included in any Promotional Materials), and GSK will



28










execute all documents and take all actions as are reasonably requested by Amgen to vest title to such Promotional Materials, Copyrights and trademarks in Amgen.


		
	3.11.
	Detailing Reports and Audit Rights.




		
	3.11.1.
	Reporting.  Each Party will provide the other Party with a report (each a “Detail Report”), in such form and manner as determined by the JSC, within twenty (20) calendar days after the end of each calendar month included in the Term, setting forth the following information regarding the efforts of the reporting Party’s sales force in Detailing Ivory during the preceding month: (i) the total number of Details made by such sales force, including a breakdown of First Position Details, Second Position Details and Other Details by target and frequency of Detail by customer priority; and (ii)  such other information as may be specified by the JSC or JBT.




		
	3.11.2.
	Audits.  Each Party will keep complete and accurate records of its Detailing of Ivory in sufficient detail to permit the other Party to audit its performance of Details hereunder.  During normal business hours and with not less than ten (10) days’  advance  written  notice,  a  Party  will  permit  the  other  Party  or  its authorized  representatives  to:  (i)  have  access  to  the  records  of  Detailing activities maintained by such Party for purposes of verifying the accuracy of reports described in Section 3.12.1 (Reporting); and (ii) audit such records; provided, that such audits may not be performed by a Party more than once per calendar year.   Any and all audits undertaken pursuant to this Section 3.11.2 (Audits) will be performed at the sole and exclusive expense of the auditing Party and will not be included in Amgen Costs or GSK Costs, as the case may be, for purposes of calculating Collaboration Profit (Loss).  If an audit reveals an overstatement of Details of greater than five percent (5%) of the correct amount for the audited period, then the audited Party will pay the reasonable out-of-pocket cost of such inspection.




		
	3.12.
	Medical Inquiries and Product Inquiries.   GSK will comply with the directions and policies which Amgen may formulate concerning responses to be made to medical questions or inquiries from members of the medical and paramedical professions and consumers regarding Ivory (including, if so directed, by referring such questions or inquiries to Amgen) and will, if so requested by Amgen, provide Amgen with details of inquiries received and responses given (including reporting regulatory and safety information as provided in Section 10.1.5 (Regulatory and Safety Information).   For questions which GSK and its professional sales representatives have not received prepared  answers  or  which  are  not  answered  by  then  existing  Ivory  information provided by Amgen (including with respect to technical information such as identification, ingredients or stability/storage), GSK will refer such questions to Amgen. For medical inquiries related to Ivory, including those related to information outside of labeling or which GSK and its professional sales representatives are unable or not authorized under accepted national and international pharmaceutical industry codes of practices to answer, GSK will redirect such inquiries to Amgen.   Unless otherwise determined by the JSC, all responses to such medical inquiries from patients, medical professionals, or other third Parties will be provided solely by Amgen.   GSK will



29










provide reasonable assistance to Amgen, at Amgen’s request and expense, in an effort to fully respond to such communications.


		
	3.13.
	Samples.  The JBT will determine and specify in the Brand Plan whether and in what manner and quantities of samples of Ivory (“Samples”) will be provided to customers. If the JBT determines that Samples will be provided through the sales force, Amgen will provide GSK with such Samples which GSK will use solely in Detailing Ivory in accordance with the Brand Plan.  The Parties will maintain such records with respect to Samples as are required by Applicable Law and applicable national and international pharmaceutical industry codes of practices and will allow representatives of the other Party to inspect such records on reasonable request.  Amgen will be solely responsible for the filing of any necessary or required reports to Governmental Authorities with respect to Samples, and GSK will reasonably cooperate with Amgen with respect thereto.  If Samples are to be provided through sales representatives, Amgen will ship the Samples to one central warehouse of GSK, as designated by GSK, and the risk of loss and responsibility for handling and warehousing of Samples will pass to GSK upon delivery to a carrier designated by GSK.   GSK will be responsible for distributing Samples to its sales representatives in a timely manner.   If Amgen determines that another method of Sample distribution is more appropriate, then the Parties will reasonably cooperate to facilitate such distribution.  Each Party will be responsible for securing the return of and reconciling existing Sample inventories from its own discontinued field sales representatives and other personnel.   Within thirty (30) days after the expiration or termination of this Agreement, or as otherwise requested by Amgen, GSK will return, or otherwise dispose of in accordance with instructions from Amgen, all remaining Samples provided by Amgen and will provide Amgen with a certified statement that all remaining Samples have been returned or otherwise properly disposed of and that GSK is no longer in possession or control of any such Samples.




		
	3.14.
	Non-Commercial Activities.   Unless otherwise determined by the JDC, Amgen will have the sole right to perform, itself or through its Affiliates or designees, all non- commercialization activities with respect to Ivory in the Collaboration Scope.   In addition, Amgen will have the sole right to perform activities with respect to Ivory outside the Collaboration Scope and GSK will not promote or conduct any activities with respect to Ivory outside the Collaboration Scope except as may be expressly agreed pursuant to a written agreement between the Parties.  Activities to be conducted by Amgen with respect to Ivory in the Collaboration Scope include:




		
	3.14.1.
	Research and Development.   Global research and development activities in accordance with the Development Plan, including Phase IV Trials, generation of health economics information, and approval of requests to perform ISS;




		
	3.14.2.
	Regulatory.    Seeking,  obtaining  and  holding  all  Regulatory  Approvals  and holding and controlling all Regulatory Filings for Ivory in each of the Collaboration Territory countries, as well as responsibility for all regulatory interactions and communications in the Collaboration Territory;




		
	3.14.3.
	Safety.   Maintaining the global safety database and core data sheet for Ivory, assessing and reporting adverse events, and handling any product complaints and/or recalls; and



30










		
	3.14.4.
	Manufacturing.   All manufacturing of Ivory for all indications and uses in accordance with applicable product specifications and GMP, including labeling, fill/finish, packaging, selection of presentations and manufacturing-related regulatory activities (including regulatory inspections).  GSK will have the right to audit Amgen’s manufacturing facilities and any Third Party manufacturing facilities used for the manufacture of Ivory in the Collaboration Scope on a periodic basis, not to exceed once every eighteen (18) months for routine audits (“Routine Audits”) or as defined below with respect to for-cause audits (“For Cause Audits”) (provided such request is made within sixty (60) days of GSK being informed of or becoming aware of an event that would permit a For Cause Audit in GSK’s reasonable opinion).  GSK will bear the cost of all Routine Audits and For Cause Audits of Amgen manufacturing facilities conducted by GSK and such costs will not be subject to cost-sharing between the Parties under this Agreement.  The costs of any Routine Audits and For Cause Audits of any Third Party manufacturing facility requested by GSK will be included in GSK Costs and will be subject to the cost-sharing principles under this Agreement,  unless  otherwise  provided  below.    GSK  will  notify  Amgen  in writing if GSK desires to conduct any manufacturing audit, and the Parties will mutually agree upon reasonable audit agendas in advance and reasonably cooperate in the conduct of such audit.  If GSK notifies Amgen that GSK desires to conduct either a For Cause Audit or Routine Audit of a Third Party manufacturer, Amgen will notify GSK if Amgen’s contract with such Third Party manufacturer permits GSK to conduct such audit, in which case Amgen will  allow  GSK  to  conduct  such  audit  (with  Amgen’s  participation,  if  it chooses).   If Amgen’s contract with such Third Party manufacturer does not permit GSK to conduct audits, then Amgen will conduct such audit and share the results with GSK to the extent permitted under Amgen’s contract with such Third Party manufacturer.   Notwithstanding the foregoing, the Parties will cooperate  to  coordinate  and  achieve  reasonable  efficiencies  with  respect  to audits of Third Party manufacturers as follows:  (i) if GSK requests a Routine Audit of a Third Party manufacturer, and Amgen has conducted a Routine Audit of such manufacturer in the previous eighteen (18) months, then Amgen will share with GSK the results of any Routine Audit of such Third Party (to the extent permitted under Amgen’s contract with such Third Party manufacturer), (ii) if after sharing the results described under (i), GSK would like to proceed with a Routine Audit of such Third Party, then, to the extent permitted under Amgen’s contract with such Third Party manufacturer, GSK may conduct such Routine Audit (or, to the extent permitted under Amgen’s contract with such Third Party manufacturer, Amgen will conduct such Routine Audit if GSK is not permitted to do so under the applicable Third Party manufacturing contract) and the costs of such Routine Audit will be borne by GSK and will not be subject  to  cost-sharing under  this  Agreement.    Any  audit  of  a  Third  Party manufacturer will be subject to the terms and conditions of Amgen’s contract(s) with such manufacturer and GSK will cooperate and coordinate with Amgen to comply with all reasonable terms and conditions communicated by Amgen in connection  with  the  performance  of  such  audit.   Any  audit  of  an  Amgen



31










manufacturing facility will comply with Amgen’s reasonable policies and procedures.    GSK’s  Routine  Audits  will  be  limited  in  scope  to  what  is reasonably necessary to confirm that Amgen or a Third Party manufacturer has complied with all applicable product specifications, GMP or GDP requirements in manufacturing Ivory.  GSK’s For Cause Audits will be limited in scope to what is reasonably necessary to confirm that the cause for such audit has been or is being remedied.  Any information disclosed to GSK in the course of any audit may only be used for the purposes of such audit.  Any audit conducted under this Agreement, the Expansion Agreement or the relevant Ivory supply agreement between Amgen and GSK will be considered an audit conducted under all such agreements.    For the purposes of this Section 3.14.4 (Manufacturing), the following will give GSK the right to conduct a For Cause Audit: (a) receipt of a warning letter pertaining to manufacturing concerns or issues for Ivory from the relevant Governmental Agency; (b) a recall of Ivory in the Collaboration Scope based on manufacturing concerns or issues; (c) product complaints evidencing material manufacturing concerns or issues for Ivory; and (d) more than one (1) lot failure or stability failure of Ivory in any calendar year that indicates a likely manufacturing concern or issue.   The JSC will review events that may give rise to the right  to conduct a For Cause Audit if so requested by either Party.


		
	4.
	COLLABORATION ACTIVITIES – PERFORMANCE STANDARDS




		
	4.1.
	Collaborative Activities.  Activities to be undertaken by the Parties hereunder will be conducted  in  a  collaborative  manner  as  determined  by  the  committee  or  team overseeing such activities, and in accordance with the terms and conditions of this Agreement, as applicable.




		
	4.2.
	Diligence and Performance Standards.    Subject to the decisions made by and oversight of the teams and committees established hereunder, each Party will use, and will assure that each of its Affiliates use, Commercially Reasonable Efforts in the performance of its and their activities hereunder.  Each Party will conduct, and ensure that each of its Affiliates conduct, all of its and their activities with respect to the promotion and commercialization of Ivory in the Collaboration Scope in accordance with this Agreement, the Brand Plan, applicable Country Plans, accepted national and international pharmaceutical industry codes of practices in and for the Collaboration Territory, and all Applicable Law.   Amgen will conduct, and ensure that each of its Affiliates conduct (and, to the extent the Parties may agree in writing that GSK or its Affiliates will conduct any activities with respect to the manufacture, distribution or development of Ivory in the Collaboration Scope, then GSK will conduct, and ensure that each of its Affiliates conduct), all of its and their activities with respect to the manufacture, distribution and development of Ivory in the Collaboration Scope in accordance with this Agreement and all Applicable Law including GMP and GDP.  The Parties will provide each other with all reasonably requested cooperation to enable each of them to comply with Applicable Law and accepted national and international pharmaceutical industry codes of practices, including permitting each Party to verify the other Party’s compliance therewith.





32










		
	4.3.
	Detailing Activities.   Each Party’s sales representatives will conduct the Detailing activities under this Agreement in accordance with the relevant codes of practice established by the Party employing such representative, and nothing herein will be interpreted to require lower standards of conduct with respect to such sales representatives than those required in the codes of practice established by the Party employing such representatives.  In addition:




		
	4.3.1.
	Minimum Sales Activities.  Each Country Team will determine, in accordance with the Brand Plan, and will set forth in the applicable Country Plan, the number of: (i) primary care sales representatives to be provided by GSK for Detailing Ivory and a minimum number of Details to be conducted by such sales representatives, and (ii) specialty care sales representatives to be provided by  Amgen  for  Detailing  Ivory  and  a  minimum  number  of  Details  to  be conducted by Amgen.  The minimums will be subject to periodic adjustments by the applicable Country Team (subject to approval by the JSC).   Unless otherwise determined by the JSC or the relevant Country Team, GSK will Detail at least those primary care prescribers who in the aggregate are expected to prescribe eighty percent (80%) of PMO prescriptions in such country (provided, however, that in Germany GSK will Detail no less than the top three (3) deciles of prescribers), and at least sixty percent (60%) of GSK’s Details of Ivory in the Collaboration Territory will be First Position Details; provided, that  the  first  sleeve  of sales  representatives  will  Detail  Ivory  only  as First Position Details, unless otherwise determined by the relevant Country Team). The Parties will not Detail Ivory in the Collaboration Scope except as expressly set forth in the Brand Plan (including with respect to Detailing only to those types of healthcare professionals as set forth in the Brand Plan) and the applicable Country Plan and GSK will not promote or Detail Ivory outside the Collaboration Scope.  Notwithstanding the foregoing, the Parties agree that to achieve the maximum effect of increasing prescribing preferences of Ivory, the JSC or JBT may determine that there will be sales representatives of each Party that are solely dedicated to Detailing Ivory in the Collaboration Scope, and that, for the first three (3) years following the Effective Date, the Amgen sales representatives are expected to promote only Ivory unless otherwise determined by the JSC.




		
	4.3.2.
	Sales Force Minimum.  Each Party will only use its employees to perform sales activities under this Agreement, including as sales representatives and sales managers, and will not utilize a contract sales organization to fulfill its obligations   to   Detail   Ivory   in   the   Collaboration   Scope.      Each   sales representative of GSK that will Detail Ivory and each sales manager for Ivory of GSK will have comparable educational qualifications and experience as Amgen requires for its own sales representatives and sales managers for Ivory; provided, that if GSK requires stricter standards applicable to its sales representatives pursuant to its codes of practice, then those additional standards will also apply to GSK’s sales representatives.  All sales representatives of each Party will have, prior to being assigned to Detail Ivory, at least two (2) years of prior experience promoting and Detailing pharmaceutical products in the three (3) years previous to being assigned to Detail Ivory and will have received appropriate training on





33










proper marketing and sales techniques to be used in promoting pharmaceutical products in accordance with all Applicable Law and applicable national and international pharmaceutical industry codes of practices.  At least fifty percent (50%) of sales representatives of each Party will have, in the four (4) years previous to being assigned to Detail Ivory, experience selling pharmaceutical products for post-menopausal osteoporosis and related women’s health conditions, such as osteopenia; provided, that for the first two (2) years following the first commercial sale of Ivory in Germany in the Collaboration Field, Amgen’s sales representatives in Germany will be excluded from the foregoing fifty percent (50%) requirement.   All sales representatives and sales managers for Ivory of each Party will be subject to a reasonable proficiency examination relevant to Ivory (subject to Applicable Law).


		
	4.3.3.
	Sales Force Incentive Compensation   Unless otherwise agreed by the Parties, the Parties will provide for incentive compensation for their respective sales representatives Detailing Ivory that is consistent with incentive compensation for    successful,   first-in-class   novel   therapeutics   at   a   similar   stage   in commercialization.    In particular, such incentive compensation plans will be structured  to  ensure  that  Ivory’s  weighting  is  such  that  the  following percentages of total incentive compensation paid to each member of such sales force during each calendar year during the Term will be as follows:   (i) one hundred percent (100%) if such sales representative is dedicated solely to Detailing Ivory; (ii) sixty percent (60%) if such sales representative is Detailing two (2) or three (3) products, of which the First Position Details are for Ivory; (iii)  forty  percent  (40%)  if  such  sales  representative  is  Detailing  two  (2) products, of which the Second Position Details are for Ivory; (iv) thirty percent (30%) if such sales representative is Detailing three (3) products, of which the Second Position Details are for Ivory; and (v) ten percent (10%) if such sales representative is Detailing three (3) products, of which the Other Details are for Ivory.




		
	4.4.
	Violation of Laws.  Each Party will promptly notify the other Party of any violation of Applicable Law by its personnel with respect to the conduct of activities in the Collaboration Scope under this Agreement.  Upon request of the non-notifying Party, the notifying Party will promptly confer with the non-notifying Party regarding any such violation and will promptly take remedial and/or preventative action as may be reasonably required by the JSC with respect thereto.  The JSC will have the right to require the removal of any personnel that materially violates Applicable Law or applicable national or international pharmaceutical industry codes of practices from performing activities contemplated under this Agreement with respect to Ivory in the Collaboration Scope.




		
	4.5.
	Use of Affiliates and Third Party Contractors.  GSK will perform the Designated GSK Activities itself or through a wholly-owned Affiliate, and any proposed use of a Third Party to conduct Designated GSK Activities will be subject to Amgen’s prior written consent,  such  consent  not  to  be  unreasonably  withheld.    Amgen  will  perform the Designated Amgen Activities itself or through a wholly-owned Affiliate; provided, that if Amgen wishes to engage a Third Party to conduct Designated Amgen Activities of



34










material strategic importance to the Collaboration Scope, then the applicable Country Team or JSC will discuss the allocation of such Designated Amgen Activity to GSK in accordance with the principles set forth in Section 3.5; provided, that such Country Team or the JSC will not be required to do so for activities it has, prior to the Effective Date, arranged to have performed by Third Parties.   The obligations of GSK and Amgen herein also apply to their respective Affiliates.


		
	4.6.
	Affiliates.   Each Party will be responsible for compliance by its respective Affiliates with  this  Agreement  and  will  be  responsible  for  all  acts  and  omissions  of  such Affiliates as if committed or omitted by the applicable Party.




		
	4.7.
	Management of Personnel.  Each Party will have sole authority and responsibility for recruiting, hiring, managing, compensating (including paying for all benefits, wages, special incentives, workers’ compensation and employment taxes), disciplining, firing and otherwise controlling the personnel provided by such Party for performance of its obligations hereunder.  Each Party will provide the day-to-day management of its sales representatives and other personnel, including furnishing administrative support, financial resources, equipment and supplies.




		
	4.8.
	COGS.  Amgen will supply Ivory for the Collaboration Scope in a manner consistent with its general corporate practice for supply. Amgen will not systematically supply Ivory for the Collaboration Scope from higher-priced Inventory Layers for the purpose of increasing costs chargeable within the Collaboration Scope.   Currently, Amgen utilizes Inventory Layers on a first-in, first-out basis and Amgen promptly will inform the JSC if the foregoing supply structure changes.




		
	5.
	UP-FRONT PAYMENT AND MILESTONES




		
	5.1.
	Payments by GSK.




		
	5.1.1.
	Up-Front Payment.  As partial consideration for the rights granted to GSK by Amgen pursuant to the terms of this Agreement, GSK will pay to Amgen a non- refundable, non-creditable payment equal to Forty-Five Million Dollars ($45,000,000.00) within ten (10) days after receipt of an invoice after the Effective Date from Amgen, payable by wire transfer of immediately available funds in accordance with wire transfer instructions of Amgen that will be provided in writing to GSK prior to the Effective Date.




		
	5.1.2.
	Milestone Payment.  As partial consideration for the rights granted to GSK by Amgen under the terms of this Agreement, GSK will make a first non- refundable, non-creditable payment of Fifty Million Dollars ($50,000,000.00) to Amgen upon the first commercial  sale of Ivory in the Collaboration  Field in the first of the United Kingdom,  Germany,  Italy, France and Spain, and a second non-refundable, non-creditable payment of Twenty-Five Million Dollars ($25,000,000.00) to Amgen upon the first commercial  sale  of Ivory  in the Collaboration Field in five (5) or more countries including at least one (1) of the United Kingdom, Germany, Italy, France and Spain.  Amgen will provide GSK with prompt written notice upon achievement of the milestone.  GSK will make the payment associated with the achieved milestone event within sixty



35










(60) days of the date on which GSK receives an invoice from Amgen with respect to such milestone.


		
	5.2.
	Payment  Method.    Payments  pursuant  to  this  Article  5  (Up-Front  Payment  and


Milestones) will be made in accordance with the provisions of Article 7 (Payments).


		
	6.
	PROFIT/EXPENSE SHARING




		
	6.1.
	Sharing.    The  Parties  will  share  in  profits  and  losses  generated  by  Ivory  in  the


Collaboration Scope as follows:


		
	6.1.1.
	GSK Costs:  Within forty-five (45) days after the end of each calendar quarter GSK will provide Amgen a detailed, itemized report of the costs described in Sections 6.1.1.1 through 6.1.1.5 (collectively, “GSK Costs”) incurred in such quarter in such format as designated by the JSC.  Within five (5) days prior to the end of each calendar quarter GSK will provide Amgen an estimate of GSK Costs incurred and to be incurred in such quarter, and an estimate of GSK Costs to be incurred in the remaining quarters of such calendar year, in each case in such format as designated by the JSC.




		
	6.1.1.1.
	Costs  incurred  by  GSK  or  its  Affiliates  in  performing  activities allocated to GSK pursuant to Section 3.3 (Designated GSK Activities) or 3.1   (Allocation   of   Operational   Responsibility)   and   not   otherwise included in this Section 6.1.1 (GSK Costs);




		
	6.1.1.2.
	Training costs incurred in accordance with Section 3.8 (Training);




		
	6.1.1.3.
	GSK Sales Force Costs incurred in accordance with the Brand Plan and calculated in accordance with Section 6.1.10 (Calculation of Sales Force Costs).




		
	6.1.1.4.
	Defense   costs   incurred   within   or   materially   related   to   the Collaboration Scope in accordance with Section 9.7 (Defense and Settlement of Third Party Claims of Infringement) or 13.5 (Defense of Third Party Claims) (but, in each case, not including defense costs incurred by GSK in fulfilling its obligations pursuant to Section 13.1 (Indemnity by GSK)), and enforcement (and cooperation) costs within or materially related to the Collaboration Scope incurred in accordance with Section 9.8 (Enforcement); and




		
	6.1.1.5.
	Collaboration Losses.




		
	6.1.2.
	Amgen Costs:  Within forty-five (45) days of the end of each calendar quarter Amgen will provide GSK a detailed, itemized report of the costs described in Sections 6.1.2.1 through 6.1.2.13 (collectively “Amgen Costs”) incurred in such format as designated by the JSC. Within five (5) days prior to the end of each calendar quarter Amgen will provide GSK an estimate of Amgen Costs incurred and to be incurred in such quarter, and an estimate of Amgen Costs to be incurred in the remaining quarters of such calendar year, in each case in such format as designated by the JSC.  All Amgen Costs incurred on or after July 1, 2009 (whether such date is before, on or after the Effective Date) will be



36










included   in   the   profit/expense   sharing   provisions   of   this   Article   6 (Profit/Expense Sharing).


		
	6.1.2.1.
	Costs incurred by Amgen or its Affiliates in performing activities allocated to Amgen pursuant to Section 3.4 (Designated Amgen Activities) or 3.1 (Allocation of Operational Responsibility) and not otherwise included in this Section 6.1.2 (Amgen Costs);




		
	6.1.2.2.
	Any  amounts  paid  by  Amgen  to  Third  Parties  for  rights  to manufacture, use or sell Ivory in or for the Collaboration Scope to the extent not already included in COGS (but not including amounts paid by Amgen to Daiichi Sankyo or its Affiliates pursuant to the pre-existing license  agreement  pertaining  to  Ivory  between  Amgen  and  Daiichi Sankyo Company, Limited dated July 11, 2007);




		
	6.1.2.3.
	Costs   associated   with   obtaining,   maintaining   and   renewing Regulatory Filings and Regulatory Approvals pertaining to Ivory;




		
	6.1.2.4.
	Training costs incurred in accordance with Section 3.8 (Training);




		
	6.1.2.5.
	Amgen Sales Force Costs incurred in accordance with the Brand Plan and calculated in accordance with Section 6.1.10 (Calculation of Sales Force Costs);




		
	6.1.2.6.
	COGS associated with Ivory Net Revenues;




		
	6.1.2.7.
	fifty percent (50%) of Qualified Amgen R&D Costs;




		
	6.1.2.8.
	Collaboration Territory R&D Costs;




		
	6.1.2.9.
	Standard Cost of any Samples of Ivory provided in the Collaboration Scope;




		
	6.1.2.10.
	Costs associated with any recalls, returns and withdrawals of Ivory in the Collaboration Scope that are not attributable to Amgen’s or its Affiliates’ negligence or willful misconduct or Amgen’s breach of this Agreement;




		
	6.1.2.11.
	Defense   costs   incurred   within   or   materially   related   to   the Collaboration Scope in accordance with Section 9.7 (Defense and Settlement  of  Third  Party  Claims)  or  13.5  (Defense  of  Third  Party Claims)  (but,  in  each  case,  not  including  defense  costs  incurred  by Amgen in fulfilling its obligations pursuant to Section 13.2 (Indemnity by Amgen)) and enforcement (and cooperation) costs incurred in accordance with Section 9.8 (Enforcement) within or materially related to the Collaboration Scope;




		
	6.1.2.12.
	Amgen’s   costs   incurred   in   connection   with   Prosecution   and Maintenance of Ivory Intellectual Property in accordance with Section 9.6 (Prosecution and Maintenance) within or materially related to the Collaboration Scope; and




		
	6.1.2.13.
	Collaboration Losses (except as expressly provided in Section 6.5 (Collaboration Losses)).



37










		
	6.1.3.
	FTE Rate.  The FTE Rate used for calculation of costs pursuant to this Article 6 (Profit/Expense Sharing) with respect to any activity will be the relevant FTE Rate for the calendar quarter in which such activity was undertaken.




		
	6.1.4.
	Income Taxes.   For the avoidance of doubt, income and withholding taxes imposed on either of the Parties hereunder will not be included in cost sharing hereunder.




		
	6.1.5.
	Exchange Rate.  For purposes of calculating quarterly balancing payments as set forth in Section 6.1.9 (True-Up), Ivory Net Revenues, Amgen Costs and GSK Costs will be converted from local currency (if different from U.S. Dollars) to U.S. Dollars in accordance with Section 16.8 (Currency).




		
	6.1.6.
	Budget and Overruns.




		
	6.1.6.1.
	Preparation; Updating.   Promptly after the Country Teams prepare the Country Plans, the JSC will prepare the Collaboration Budget.  On an annual basis, commencing with the Collaboration Budget for 2010, the JSC will prepare the Collaboration Budget for the following calendar year based upon the input of the Country Teams and JBT.  The Parties agree that each Collaboration Budget covering a calendar year will be subject to the limitation that the total amount of such Collaboration Budget    will     not     exceed     Three     Hundred     Million     Dollars ($300,000,000.00) per year (the “Annual Cap”), and, notwithstanding anything else in this Agreement, any increase to the Annual Cap will be subject  to  mutual  agreement  of the  CRC;  provided,  that  if  the  CRC cannot mutually agree, then (without reference to Section 6.1.6.2) any amounts in excess of the Annual Cap will be borne solely by the Party incurring them and such excess will not be included in the calculation of profit (or loss) pursuant to Section 6.1.8 (Calculation of Profit (or Loss)). On an annual basis, commencing with the Development Budget for 2010, the JDC will prepare a Development Budget for the following calendar year (or update the Initial Development Budget for the following year, as applicable).   The Parties will promptly provide the JSC and JDC all reasonably requested information to facilitate the preparation or updating of each Collaboration Budget or Development Budget, as applicable, including detailed estimates of GSK Costs and Amgen Costs for the following calendar year.




		
	6.1.6.2.
	Overruns.  Each Party will provide prompt, written advance notice to the other Party if it becomes aware of any anticipated costs to be incurred by such Party in excess of the applicable Collaboration Budget or Development Budget.  Unless otherwise agreed by the Parties in advance, in writing, costs reported by a Party pursuant to Section 6.1.1 (GSK Costs) or 6.1.2 (Amgen Costs) incurred in excess of one hundred and five percent (105%) of any aggregate amounts budgeted to be incurred by or on behalf of such Party for its activities for such calendar year in the then-current Collaboration Budget or Development Budget will not be included in the calculation of profit (or loss) pursuant to Section 6.1.8



38










(Calculation of Profit (or Loss)); provided that GSK Costs and Amgen Costs in excess of such amount will be included in the calculation of profit (or loss) pursuant to Section 6.1.8 (Calculation of Profit (or Loss)) only if such costs were attributable to: (i) a change in Applicable Law; (ii) a Force Majeure event; or (iii) a change in the competitive landscape of Ivory in the Collaboration Scope that requires an amendment to the Brand Plan, applicable Country Plan or Development Plan to address such change in competitive landscape.


		
	6.1.7.
	Ivory Net Revenues.  Within forty-five (45) days after the end of each calendar quarter, Amgen will provide GSK with a reasonably detailed report of Ivory Net Revenues for such calendar quarter.




		
	6.1.8.
	Calculation of Profit (or Loss).  The total profit (or loss) for a calendar quarter will be calculated by Amgen by first deducting from Ivory Net Revenues for such quarter a percentage of such Ivory Net Revenues equal to the Inventorship Margin, which will be paid to Amgen to reflect Amgen’s inventorship of Ivory; and then deducting from the remaining Ivory Net Revenues the GSK Costs and Amgen Costs reported by the Parties pursuant to Sections 6.1.1 (GSK Costs) and 6.1.2 (Amgen Costs).   The resulting amount will be the “Collaboration Profit (Loss)” for such quarter, which will be shared by the Parties equally.




		
	6.1.9.
	True-up.  Within ninety (90) days of the end of each calendar quarter, Amgen will calculate and provide to GSK a report of the Collaboration Profit (Loss) for such quarter, and a balancing payment will be made between the Parties such that each Party bears one half of the sum of GSK Costs and Amgen Costs, and each Party receives one half of Ivory Net Revenues, after deducting the amount allocated to Amgen under Section 6.1.8 (Calculation of Profit (or Loss)) above. The net paying Party will make a payment pursuant to this Section 6.1.9 (True- up).  Payments pursuant to this Article 6 will be made in accordance with the provisions of Article 7.




		
	6.1.10.
	Calculation of Sales Force Costs.  Sales force FTE costs for each of the Parties will be determined by including in GSK Costs or Amgen Costs, as the case may be, a pro rata portion of each Party’s sales representative’s FTE Rate as follows: (i) one hundred percent (100%) if such sales representative Details only Ivory with  the  approval  of  the  JSC,  (ii)  sixty  percent  (60%)  if  such  sales representative Details two (2) products with Ivory as the First Position Detail or Details only Ivory without the approval of the JSC, (iii) forty percent (40%) if such sales representative Details two (2) products with Ivory as the Second Position Detail, (iv) thirty percent (30%) if such sales representative Details three (3) or more products with Ivory as the Second Position Detail, and (v) ten percent (10%) if such sales representative Details three (3) or more products with Ivory as the Third Position Detail.  For the avoidance of doubt, if a sales representative Details Ivory in more than one (1) position, then a pro rata share of the foregoing percentages, to be calculated based on the time spent by such sales representative on Detailing Ivory in each such position, will be included in GSK Costs or Amgen Costs, as the case may be. For periods in which sales representatives are performing activities in support of the collaboration but are



39










not Detailing Ivory (e.g., during launch preparation or training), FTE costs will be calculated in accordance with Section 6.4 (Attribution of Costs).


		
	6.2.
	Example.  The Profit (Loss) True-up Schedule sets forth an example of calculation and true-up of the quarterly Collaboration Profit (Loss).




		
	6.3.
	Calculation of Net Revenues.  In calculating Ivory Net Revenues for the purposes of this Article 6 (Profit/Expense Sharing):




		
	6.3.1.
	Free Products.  Any disposal of Ivory at no charge for, or use of Ivory without charge in, clinical or preclinical trials, given as free samples, or distributed at no charge to patients unable to purchase the same will not be included in Ivory Net Revenues.




		
	6.3.2.
	Bundled Products.  Where Ivory is sold in a Bundle, then for the purposes of calculating the Ivory Net Revenues under this Agreement, such Ivory will be deemed to be sold for an amount equal to X ÷ (X + Y) × Z, where: X is the average sales price during the applicable reporting period generally achieved for such dosage form of Ivory in the Collaboration Scope; Y is the sum of the average sales price during the applicable reporting period generally achieved in the Collaboration Territory, when sold alone, by each pharmaceutical product in the relevant dosage form included in the Bundle (excluding Ivory); and Z equals the price at which the Bundle was actually sold.  In the event that Ivory or one or more of the other pharmaceutical products in the Bundle are not sold separately in the relevant dosage form, the Ivory Net Revenues from the sale of such  Bundle  will  be  reasonably  allocated  between  Ivory  and  the  other product(s) in such Bundle based upon their relative values and the JSC will determine an equitable fair market price to apply to such bundled Ivory. Notwithstanding the foregoing, Ivory will not be sold in a Bundle if such sale would violate Applicable Law.




		
	6.4.
	Attribution of Costs.   Unless otherwise set forth herein, for costs not specific to the Collaboration Scope or the activities to be performed hereunder (including FTE costs for personnel not solely devoted to Ivory in the Collaboration Scope (but not including sales force FTE costs for sales force Detailing Ivory, which will be calculated in accordance with Section 6.1.10 (Calculation of Sales Force Costs)), the portion of such costs allocable to the collaboration may be determined based upon percent of effort, resource utilization or other reasonable measure, in each case calculated and allocated in accordance with the applicable Party’s accounting procedures, consistently applied. For clarity, no particular cost will be allocated to the collaboration more than once.




		
	6.5.
	Collaboration Losses.   Each Party understands the risks attendant to the business of Ivory within the Collaboration Scope.  Losses related to the Collaboration Scope that arise out of the development, manufacture, regulatory activities, commercialization or other exploitation of Ivory undertaken by or on behalf of a Party in the exercise of its rights or performance of its obligations under this Agreement in good faith (“Collaboration Losses”) will be charged to the Collaboration Profit (Loss); provided, that Collaboration Losses will not include Losses that are:  (i) caused by a breach of this Agreement; or (ii) subject to indemnification pursuant to Section 13.1 (Indemnity by GSK), Section 13.2 (Indemnity by Amgen) or Section 13.3 (Specific Indemnity)





40










(and for clarity, if a Third Party makes a Third Party Claim directly against GSK or Amgen, respectively, that would otherwise be indemnified by GSK or Amgen if such Third Party Claim had been made against the other Party, then Losses incurred by GSK or Amgen in connection with such direct Third Party Claim will not be Collaboration Losses).  If a Party becomes aware of a Third Party Claim that would, if successful, result in a Collaboration Loss, such Party will inform the other Party of such Third Party Claim as soon as reasonably practicable after it receives notice thereof. Notwithstanding the foregoing: (a) the first Fifty Million Dollars ($50,000,000.00) of Collaboration Losses incurred by either Party in connection with personal injury claims (regardless of the theory of liability) arising out of the administration of Ivory within the Collaboration Scope after the Effective Date (such $50,000,000.00 of Collaboration Losses, “Qualified Product Liability Losses”) will be borne solely by Amgen; (b) Qualified Product Liability Losses that are borne by GSK will be subject to indemnification pursuant to Section 13.2 (Indemnity by Amgen); and (c) Collaboration Losses from personal injury claims (regardless of the theory of liability) within the Collaboration Scope in excess of the Qualified Product Liability Losses will be charged to the Collaboration Profit (Loss) and will not be subject to indemnification hereunder.


		
	7.
	PAYMENTS




		
	7.1.
	Appropriate  Measure  of  Value.    Each  of  the  Parties  acknowledges  that  the  value provided by the other hereunder is comprised of many related items, including performance of various services, access to development and commercial expertise, clinical data and other financial and non-financial consideration and that the amount of the Inventorship Margin, and the ratio of profit and expense sharing set forth herein are intended to capture such value as an aggregate.   Therefore the increase, decrease or lapse of any particular items or rights (including Patents), including allocation of operational responsibilities between the Parties, will not affect the amount of such payment, or the ratio of profit and expense sharing and the Parties agree that both the amount and duration of such payment or the ratio of profit and expense sharing are reasonable.




		
	7.2.
	No Other Compensation.  Other than as explicitly set forth (and as applicable) in this Agreement, neither Party will be obligated to pay any additional fees, milestone payments, royalties or other payments of any kind to the other hereunder.




		
	7.3.
	Payment Method.  All payments made hereunder between the Parties will be made in U.S. Dollars except as set forth in Section 7.5 (Blocked Currency) or as otherwise agreed by the Parties.  Each Party will pay all sums due hereunder by wire transfer, or electronic funds transfer (EFT) in immediately available funds.  If the EFT option is chosen by Amgen or GSK, a completed electronic funds transfer form will be provided in a timeframe that facilitates timely payment.   Each Party will promptly notify the other Party of the appropriate account information to facilitate any such payments.




		
	7.4.
	Audits.  Each Party will keep complete and accurate records pertaining to the activities to be conducted hereunder in sufficient detail to permit the other Party (the “Auditing Party”) to confirm the accuracy of all payments due hereunder, including the Tail Payments set forth in Section 14.11, and such records will be open (in such form as may be available or reasonably requested) to inspection for three (3) years following



41










the end of the period to which they pertain.  The Auditing Party will have the right, at its own expense to have an independent, certified public accountant, selected by it, perform a review the records of the other Party (the “Audited Party”) applicable to amounts payable hereunder (including any records kept in the ordinary course of the Audited Party’s business) upon reasonable notice, during regular business hours and under reasonable obligations of confidentiality.  The report of such accountant will be made available to both Parties simultaneously, promptly upon its completion.   The Auditing Party’s right to perform an audit pertaining to any calendar year will expire three (3) years after the end of such year and the books and records for any particular calendar year will only be subject to one (1) audit.  Should an inspection pursuant to this Section 7.4 (Audits) lead to the discovery of a payment discrepancy, then the appropriate Party will pay to the other the amount of the discrepancy (plus, if the error was in favor of the Audited Party, interest accrued at the Contract Interest Rate, compounded annually from the day the relevant payment(s) were due).  If a payment discrepancy was greater than seven percent (7%) of the correct amount for the audited period and the discrepancy was in favor of the Audited Party, then the Audited Party will pay the reasonable out-of-pocket cost of such inspection, but in no case will the costs of an audit pursuant to this Section 7.4 (Audits) be included in GSK Costs or Amgen Costs allocated to the collaboration.  This Section 7.4 (Audits) does not apply to or include manufacturing audits or regulatory inspections.


		
	7.5.
	Blocked  Currency.    If  Applicable  Law  in  the  Collaboration  Territory  prevent  the prompt remittance of any payments with respect to sales therein, the paying Party will have the right and option to make such payments by depositing the amount thereof in local currency to the other Party’s account in a bank or depository in such country.




		
	7.6.
	Withholding.  If Applicable Law requires a Party to pay or withhold Taxes with respect to any payment to be made pursuant to this Agreement, the paying Party will notify the other in writing of such payment or withholding requirements prior to making the payment and provide such assistance to the receiving Party, including the provision of such documentation as may be required by a tax authority, as may be reasonably necessary in such Party’s efforts to claim an exemption from or reduction of such Taxes.  Each Party will withhold any Taxes required by law to be withheld from the amount due, remit such Taxes to the appropriate tax authority, and furnish the other Party with proof of payment of such Taxes promptly following payment thereof.   If Taxes are paid to a tax authority, each Party will provide the other such assistance as is reasonably required to obtain a refund of Taxes withheld, or obtain a credit with respect to Taxes paid.  In the event that the governing tax authority retroactively determines that a payment made by a Party to the other pursuant to this Agreement should have been subject to withholding (or to additional withholding) for Taxes, and such Party (the “Withholding Party”) remits such withholding Taxes to the tax authority, the Withholding Party will have the right to offset such amount, including any interest and penalties that may be imposed thereon, against future payment obligations of the Withholding Party under this Agreement (or, at the option of the Withholding Party, the Withholding Party will have the right to invoice the other Party for such amount, and the other Party will pay such amount within sixty (60) days of the receipt of such invoice); provided however, that the Withholding Party may also pursue reimbursement by any other available remedy.



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	7.7.
	VAT.  All payments due a Party pursuant to this Agreement will be paid exclusive of any VAT and other indirect Taxes (which, if applicable, will be payable by the paying Party upon receipt of a valid VAT invoice).  If such amounts of VAT are refunded by the applicable Governmental Authority or other fiscal authority subsequent to payment, the Party receiving such refund will transfer such amount to the paying Party within forty-five (45) days of receipt.




		
	7.8.
	Late Payment.   Any payments or portions thereof due hereunder which are not paid when due will bear interest at the Contract Interest Rate, compounded annually, calculated on the number of days such payment is delinquent.  This Section 7.8 (Late Payment) will in no way limit any other remedies available to either Party.




		
	7.9.
	Change in Accounting Periods.  From time to time, either of the Parties may change its accounting and financial reporting practices from calendar quarters and calendar years to fiscal quarters and fiscal years or vice versa.  If a Party notifies the other in writing of a change in its accounting and financial reporting practices from calendar quarters and calendar years to fiscal quarters and fiscal years or vice versa, then thereafter, beginning  with  the  period  specified  in  the  notice,  the  Parties  will  cooperate  to determine a way to report and reconcile each Party’s accounting periods so as to facilitate payments to be made hereunder.




		
	8.
	DISTRACTING PRODUCTS




8.1.    Distracting  Program.     Except  as  set  forth  in  Sections  8.2  (Post-Effective  Date Affiliates), 8.3 (Termination or Divestiture) and 8.4 (Pre-Effective Date Programs):


		
	8.1.1.
	GSK will not, during the Term and for one (1) year thereafter, itself, through its Affiliates or any other entity which is controlled by GSK, conduct or participate in, or advise, assist or enable any Third Party to conduct or participate in, any Distracting Program;




		
	8.1.2.
	Amgen will not, during the Term, itself, through its Affiliates or any other entity which is controlled by Amgen, conduct or participate in, or advise, assist or enable any Third Party to conduct or participate in, any Distracting Program in the Collaboration Territory.




For the purposes of this Section 8.1 (Distracting Program) “control” means the possession solely by the relevant Party (together with its Affiliates), of the power to direct or cause the direction of management and policies of an entity, whether through the ownership of Voting Securities, by contract or otherwise.


		
	8.2.
	Post-Effective Date Affiliates.  If a Party enters into a Distracting Transaction then it will provide notice to the other Party, within five (5) business days of the closing of the Distracting Transaction, describing in reasonable detail, to the extent permitted by Applicable Law and without disclosing any proprietary information, the Distracting Program.  During the pendency of any potential Distracting Transaction, and until the provisions of Section 8.3 (Termination or Divestiture) are fully implemented, the Party entering into the Distracting Transaction will Segregate the Distracting Program from Ivory.



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	8.3.
	Termination  or  Divestiture.    The  notice  provided  pursuant  to  Section  8.2  (Post- Effective Date Affiliates) will include a notification as to whether the Party entering into the Distracting Transaction intends to Divest or terminate the Distracting Program in accordance with this Section 8.3 (Termination or Divestiture):




		
	8.3.1.
	Divestiture.   If a Party elects to Divest the Distracting Program, then it will Segregate such Distracting Program from the Ivory program and Divest such Distracting Program within six (6) months of the closing of the Distracting Transaction.  The divesting Party and its Affiliates (including the Affiliate with the Distracting Program) will not directly or indirectly assert any intellectual property or proprietary right embodied in the Distracting Program and under the control of the divesting Party or its Affiliates as a result of the Distracting Transaction, against or with respect to Ivory or otherwise obstruct the Parties’ (or their Affiliates, sublicensees’, contractors’ or agents’) efforts under this Agreement or the Expansion Agreement or, if GSK is the divesting Party, Amgen’s (or its Affiliates, sublicensees’, contractors’ or agents’) efforts with respect to Ivory outside the Collaboration Scope.  If the Party fails to complete a divestiture within six (6) months of the closing of the Distracting Transaction, then such Party will be deemed to have chosen to terminate the Distracting Program, effective as of such six (6) month anniversary, and will promptly comply with the requirements of Section 8.3.2 (Termination); provided, that if at the expiration of such six (6) month period, the divesting Party has agreed terms with a Third Party to Divest the Distracting Program then such six (6) month period will be extended as required for the divesting Party and such Third Party to consummate the transaction, but in no event will such extension exceed an additional ninety (90) days.




		
	8.3.2.
	Termination.   If a Party elects to terminate such Distracting Program, it will terminate all activities of such Distracting Program within ninety (90) days of the closing of the Distracting Transaction, during which period it will Segregate such Distracting Program from the Ivory program.  The terminating Party and its Affiliates will not directly or indirectly assert any intellectual property or proprietary right of the Distracting Program against or with respect to Ivory or otherwise to obstruct the Parties’ (or their Affiliates, sublicensees’, contractors’ or agents’) efforts under this Agreement or the Expansion Agreement or if GSK is the terminating Party, Amgen’s (or its Affiliates, sublicensees’, contractors’ or agents’) efforts with respect to Ivory outside the Collaboration Scope during such termination period or thereafter.




		
	8.4.
	Pre-Effective Date Programs.




		
	8.4.1.
	GSK has advised Amgen that GSK is currently a party to the Roche Agreement.


GSK acknowledges that Amgen has not requested that GSK take, or caused GSK to take, any action that, or omit to take any action the omission of which, would be reasonably likely to cause a material breach of the Roche Agreement or disrupt or interfere in a material way with the activities contemplated to be undertaken by GSK or Roche under the Roche Agreement.   Notwithstanding anything in this Article 8 (Distracting Products), GSK may continue, in its discretion, to exercise its rights and obligations under the Roche Agreement;

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provided, that GSK will Segregate the Ivory program and the BonvivaTM program;  and  provided,  further  that  Personnel  that  have  previously  been working on the BonvivaTM program in such country may thereafter work on the Ivory program, but will continue to Segregate information from the BonvivaTM program from the Ivory program.  The exception set forth in this Section 8.4.1 to GSK’s obligations under Section 8.1 (Distracting Program) will apply until the earlier of either (i) December 31, 2011 or (ii) the expiration or termination of (a) on a country-by-country basis with respect to countries in the Collaboration Territory, GSK’s right to commercialize BonvivaTM under the Roche Agreement, or (b) the Roche Agreement in its entirety (the “Exception Expiration Date”), at which time the exception to exclusivity set forth in this Section 8.4 (Pre-Effective Date Programs) will terminate (either on a country- by-country basis or in its entirety, as applicable) and be of no further force or effect.   GSK   will   continue   to   Segregate   pricing   information   regarding BonvivaTM from the Ivory program until June 30, 2012; provided, that “Segregation” as used in this sentence does not prevent Personnel that have worked on the BonvivaTM program from working on the Ivory program but will require  confidential  pricing  information  with  respect  to  BonvivaTM  to  be separate from and not used in connection with, the Ivory program.


		
	8.4.2.
	For  the  avoidance  of  doubt,  Amgen’s  current  and  future  anti-sclerostin programs will not be considered “Distracting Programs.”




		
	8.5.
	Reasonable Restrictions.    Each  of  the  Parties  acknowledges  the  provisions  of  this Article 8 (Distracting Products) are reasonable and necessary to protect the legitimate interests of the other Party and to encourage the free sharing of information between the Parties with respect to Ivory, and each of the Parties agrees not to contest such limitations in any proceeding.  Each Party acknowledges that the other Party would not have entered into this Agreement absent the restrictions set forth in this Article 8 (Distracting Products) and that a breach or threatened breach of this Article 8 (Distracting Products) would be likely to result in irreparable harm to such Party for which there is no adequate remedy at law.   Therefore, the Parties will be entitled to obtain from any court of competent jurisdiction injunctive relief, specific performance, and an equitable accounting of any earnings, profits or benefits arising out of any such breach without the requirement to post a bond or to demonstrate irreparable harm, balancing of harms, consideration of the public interest or inadequacy of monetary damages as a remedy.  Nothing in this Section 8.5 (Reasonable Restrictions) is intended or will be construed to limit in any way either Party’s right to equitable relief or any other remedy for breach of this or any other provision of this Agreement.




		
	8.6.
	Amgen Restrictions.  During the Term, Amgen and its Affiliates will not Detail Ivory in the Excluded Field in the Collaboration Territory in any presentation that is not indicated for use in the Excluded Field in the Collaboration Territory.




		
	8.7.
	Segregation  of  Programs.     GSK  will  Segregate  any  Distracting  Product  being developed or manufactured by GSK from Ivory.



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	9.
	INTELLECTUAL PROPERTY




		
	9.1.
	Invention Ownership.   Each Party will own all right, title, and interest in and to all Inventions that are made by or on behalf of such Party, solely or independent of the other Party, and all intellectual property rights related thereto (including in the case of GSK, GSK Inventions), and any Invention that is jointly made will be owned jointly by the Parties (each a “Joint Invention”).   Inventorship will be determined according to United States Patent Law (without reference to any conflict of law principles).




		
	9.2.
	Copyright Ownership; Certain Confidential Information.   Except as set forth below, each Party will own all right, title, and interest in and to all Copyrights created pursuant to this Agreement that are authored by or on behalf of such Party, solely or independent of the other Party, and all intellectual property rights related thereto; provided that any Copyrights pertaining to Ivory (including any clinical trial protocols, investigator brochures and informed consent forms, and including the product labeling, package inserts, core data sheet and all marketing and promotional materials and including the Brand Book) will be owned solely by Amgen.  The Parties will jointly own all right, title, and interest in and to all Copyrights that are authored by or on the behalf of the Parties jointly; provided that any Copyrights pertaining to Ivory will be owned solely by Amgen whether created jointly by the Parties or by either Party independent of the other Party.  In addition, all Confidential Information to the extent pertaining to Ivory will be the Confidential Information of Amgen (and not of GSK), regardless of which Party created such information (and will not be subject to the exclusion under Section 11.1.1 or 11.1.4).  Any Copyrights created by GSK or its Affiliates and specified in this Section 9.2 (Copyright Ownership) as being owned by Amgen will be considered a work for hire.  To the extent any such Copyright is not considered a work for hire, GSK and/or such Affiliate will assign and does hereby assign to Amgen all of its right, title and  interest  in  and  to  such  Copyright  and  intellectual  property  rights  therein  and thereto.   Each Party will duly execute, acknowledge, and deliver to the other all such further papers, including assignments and applications for copyright registration or renewal, as may be reasonably requested and/or necessary to enable such other Party to publish or protect said Copyrights in any and all countries and to vest title to said Copyrights in such other Party (or its nominees, or its or their successor or assigns) in accordance with this Section 9.2 (Copyright Ownership), and will render such reasonable assistance, at such other Party’s expense, as such other Party may reasonably require in any proceeding or litigation involving said Copyrights.




		
	9.3.
	Joint Ownership.  Except as expressly provided in this Agreement, it is understood that neither Party will have any obligation to obtain any approval or consent of, nor pay a share of the proceeds to or account to, the other Party to practice, enforce, license, assign or otherwise exploit Inventions or intellectual property (including Copyrights) owned jointly by the Parties hereunder, and each Party hereby waives any right it may have under the laws of any jurisdiction to require such approval, consent or accounting. Each Party agrees to cooperate with the other Party, as reasonably requested, and to take such actions as may be required to give effect to this Section 9.3 (Joint Ownership) in a particular country within the Collaboration Territory.




		
	9.4.
	License Grant by Amgen.  Amgen hereby grants and causes its Affiliates to grant to GSK and its Affiliates during the Term a non-exclusive, fully-paid, royalty-free license



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to Ivory Intellectual Property solely to the extent necessary to Detail Ivory in the Collaboration Scope, conduct the Designated GSK Activities, and exercise and perform GSK’s other rights and obligations under the terms of this Agreement.


		
	9.5.
	License Grant by GSK.  GSK hereby grants and causes its Affiliates to grant to Amgen and its Affiliates a non-exclusive, irrevocable, fully-paid, royalty-free, world-wide license under all Know-How and Patents owned or controlled as of the Effective Date or during the Term (including GSK Inventions) by GSK or its Affiliates solely to use, make, have made, sell, offer for sale and import Ivory for all uses, and for performing Amgen’s rights and obligations hereunder.  Such license is sublicensable by Amgen or its Affiliates solely to Third Parties to whom Amgen or its Affiliates also grant a license to Know-How or Patents owned or controlled by Amgen claiming Ivory, its formulation or the use thereof; provided, that such sublicense will terminate no later than the date on which the license to the Third Party to Amgen Know-How or Patents described above terminates.




		
	9.6.
	Prosecution  and  Maintenance.    Subject  to  the  provisions  of  Section  2.14  (Patent Coordinators), Amgen will control, itself or through outside counsel, and have final decision making authority (after consultation with GSK in accordance with the terms and conditions of this Agreement) with respect to the Prosecution and Maintenance of the Patents and Product Trademarks within the Ivory Intellectual Property in the Collaboration Territory (the “Ivory Patents and Trademarks”), and with respect to preparation and filing for any patent term extensions or similar protections therefor. Through the Patent Coordinators: (i) Amgen will provide GSK with copies of and an opportunity to review and comment upon the text of the applications relating to the Ivory Patents and Trademarks at least thirty (30) days before filing; provided, that if it is not reasonably practicable to provide such application in such thirty (30) day period, then Amgen will provide either a draft copy of such application or a statement of intent to file such application in such thirty (30) day period; (ii) Amgen will provide GSK with  a  copy  of  each  submission  made  to  and  document  received  from  a  patent authority, court or other tribunal regarding any Ivory Patent and Trademark reasonably promptly after making such filing or receiving such document, including a copy of each application for each Ivory Patent and Trademark as filed together with notice of its filing date and application number; (iii) Amgen will keep GSK advised of the status of all material communications, actual and prospective filings or submissions regarding the Ivory Patents and Trademarks, and will give GSK copies of and an opportunity to review and comment on any such material communications, filings and submissions proposed to be sent to any patent authority or judicial body; and (iv) Amgen will consider  in  good  faith  GSK’s  comments  on  the  communications,  filings  and submissions for the Ivory Patents and Trademarks.  With respect to any filings or other materials provided to GSK under this Section 9.6 (Prosecution and Maintenance), Amgen  will  have  the  right  to  redact  any  manufacturing  information  and  any information  relating  to  any  product  other  than  Ivory  from  any  such  filings  and materials.




		
	9.7.
	Defense and Settlement of Third Party Claims of Infringement.  If a Third Party asserts that Patents, Know-How or other rights owned or controlled by it are infringed by the activities  hereunder  of  either  of  the  Parties,  then  defense  of  such  claim  (an





47










“Infringement Claim”) will be managed in accordance with the provisions of Section
13.5 (Defense of Third Party Claims), with coordination and cooperation between the Defending Party and Assisting Party occurring via the Patent Coordinators.  If either Party seeks to initiate a nullification or revocation proceeding against any such Patents, Know-How or other rights in response to prospective or actual Third Party Claims of Infringement, the Parties will coordinate and cooperate in regard to such proceedings in accordance  with  the  procedures set  forth  in  Section 13.5 (Defense  of Third  Party Claims), with coordination and cooperation between the Defending Party and Assisting Party occurring via the Patent Coordinators.


		
	9.8.
	Enforcement.   Except as expressly set forth in this Section 9.7 (Enforcement), each Party will retain all its rights to control the enforcement of its own intellectual property. Amgen will have the sole right to enforce the Ivory Intellectual Property.  GSK will reasonably assist Amgen with respect to any such enforcement in the Collaboration Territory, including, in the event that it is determined that the GSK is an indispensable Party to such action, by being named as a Party in such action, and cooperate in any such action at Amgen’s request.    Without limiting the foregoing, Amgen will keep GSK advised of all material communications, actual and prospective filings or submissions regarding such action, and will provide GSK copies of and an opportunity to review and comment on any such material communications, filings and submissions (provided that Amgen will have the right to redact any manufacturing information and any information relating to any product other than Ivory from any such materials).  All Recoveries will be retained by Amgen, but included in Ivory Net Revenues for the period in which such Recovery is made.




		
	9.9.
	Patent  Term  Extensions.    GSK  will  provide  reasonable  assistance  to  Amgen  in connection with obtaining supplemental protection certificates for Patents within the Ivory Intellectual Property or otherwise licensed or assigned hereunder as determined by the Patent Coordinators.  To the extent reasonably and legally required to obtain any such supplemental protection certificates in a particular country, GSK will make available to Amgen copies of all necessary documentation to enable Amgen to use the same for the purpose of obtaining the supplemental protection certificates in such country.




		
	9.10.
	Employee Agreements.  Prior to beginning work relating to any aspect of the subject matter of this Agreement and/or being given access to Ivory Intellectual Property or Confidential Information of the other Party, each employee, consultant and/or agent of Amgen and GSK will have signed or will be bound to a commercially reasonable non- disclosure and/or invention assignment agreement.  Each Party will be responsible for any compensation or payment to its employees, contractors or agents in connection with the invention of any patent right.




		
	9.11.
	Trademarks.




		
	9.11.1.
	Title.    Amgen  will  own  all  right,  title  and  interest  in  and  to  the  Product Trademarks, and GSK agrees to assign and hereby assigns to Amgen all right title and interest that GSK has or may acquire in connection with the Product Trademarks.  All goodwill arising out of the use of the Product Trademarks or otherwise related to Ivory will inure to the benefit of Amgen.  GSK will not,



48










and will ensure that its Affiliates do not: (i) challenge any Product Trademark or the  registration  thereof  in  any  country;  (ii) file,  register  or  maintain  any registrations for the Product Trademarks, or for any trademarks or trade names that are confusingly similar to any Product Trademark, in any country without the express prior written consent of Amgen, and such permitted registrations (if any) will be filed, registered or maintained by GSK in Amgen’s name; or (iii) authorize or assist any Third Party to do the foregoing.


		
	9.11.2.
	Required Use and Compliance.




		
	9.11.2.1.
	Promotional  Materials  for  Ivory  in  the  Collaboration  Scope  will display the Amgen Housemarks and the GSK Housemarks to the extent allowed  by Applicable  Law  and  in  accordance  with  the  Brand  Plan. Except for the use of the Amgen Housemarks and the GSK Housemarks as may be expressly set forth in the Brand Plan, each Party will promote Ivory in the Collaboration Scope only under the Product Trademarks.




		
	9.11.2.2.
	GSK agrees that it and its Affiliates will: (i) ensure that each use of the Product Trademarks and/or the Amgen Housemarks by GSK is accompanied by an acknowledgement that the Product Trademarks and Amgen  Housemarks  are  owned  by  Amgen;  (ii) not  use  the  Product Trademarks or Amgen Housemarks in a way that might materially prejudice their distinctiveness or validity or the goodwill of Amgen therein; and (iii) not use any trademarks or trade names so resembling any of the Product Trademarks or Amgen Housemarks as to be likely to cause confusion or deception.  Amgen agrees that it and its Affiliates will ensure that each use of the GSK Housemarks by Amgen is accompanied by an acknowledgement that the GSK Housemarks are owned by GSK.




		
	9.11.3.
	Licenses.




		
	9.11.3.1.
	To GSK.   Amgen hereby grants to GSK a non-exclusive, royalty- free license to use the Product Trademarks and Amgen Housemarks as set forth in the Promotional Materials and other materials provided to it by  Amgen,  solely  to  Detail  Ivory  in  the  Collaboration  Scope  in accordance  with  the  Brand  Plan,  Country  Plans  and  this  Agreement during the period that GSK has rights to Detail Ivory hereunder.  GSK’s right to use the Product Trademarks and the Amgen Housemarks will terminate, on a country-by-country basis, when GSK’s rights to Detail Ivory in such country are terminated or expire.  GSK will take all such steps as Amgen may reasonably request to give effect to the termination of the license to the Product Trademarks and Amgen Housemarks in such country and to record any documents that may be required to evidence the termination of such license.




		
	9.11.3.2.
	To Amgen.  GSK hereby grants to Amgen a non-exclusive, royalty- free license to use the GSK Housemarks as set forth in the Promotional Materials solely to Detail Ivory in the Collaboration Scope in accordance with the Brand Plan, Country Plans and this Agreement.  Amgen’s right to use the GSK Housemarks will terminate, on a country-by-country



49










basis,  when  GSK’s  rights  to  promote  Ivory  in  such  country  are terminated or expire; provided, that the license set forth in this Section 9.11.3.2 (To Amgen) will continue for a period of six (6) months to permit  Amgen  to  use  and  distribute  its  inventory  of  Promotional Materials containing GSK Housemarks in such country (or, where the on-hand inventory as of such termination or expiration of such Promotional Materials cannot practically be used within such six (6) month period, such longer period as reasonably necessary to exhaust such Promotional Materials, but in no event longer than twelve (12) months), in connection with Amgen’s Detailing of Ivory.   Amgen will take all such  steps  as  GSK  may  reasonably  request  to  give  effect  to  the termination of the license to the Collaboration Housemarks in the applicable country and to record any documents that may be required to evidence the termination of such license.


		
	9.11.4.
	Respect of Trademarks.  GSK will not have, assert or acquire any right, title or interest in or to any of Product Trademarks or Amgen Housemarks or the goodwill pertaining thereto, and Amgen will not have, assert or acquire any right, title or interest in or to the GSK Housemarks or the goodwill pertaining thereto, in each case by means of entering into or performing under this Agreement, except in each case for the limited licenses explicitly provided in this Agreement.




		
	9.11.5.
	Infringement   Amgen will monitor the Product Trademarks against infringing uses within the Collaboration Scope.  GSK will give Amgen prompt notice of any infringement or threatened infringement of any of the Product Trademarks of which it becomes aware.  Amgen will determine in its sole discretion what action, if any, to take in response to any such infringement or threatened infringement of any Product Trademark.




		
	9.12.
	Community Of Interest.   From time-to-time it may be desirable or beneficial to the Parties to share between each other and their respective outside counsel privileged and/or work product information with respect to certain Patents and/or Know-How related to Ivory, and legal matters relating thereto, and that they share a common interest in the prosecution, defense and enforcement of such Patents and Know-How, including  such  Patents  and  Know-How  owned  or  controlled  by  Third  Parties. Therefore,  the  Parties agree  to  execute  the  Joint  Community  Of  Interest  Privilege Agreement (attached hereto as the Privilege Agreement Schedule) concurrently with this Collaboration Agreement.




		
	10.
	REGULATORY AND SAFETY




		
	10.1.
	Regulatory Matters.




		
	10.1.1.
	Regulatory  Communication  and  Filings.     Amgen  will  use  Commercially Reasonable Efforts to prepare, submit and maintain all Regulatory Filings and to obtain all Regulatory Approvals for Ivory in the Collaboration Scope, including making all Regulatory Filings necessary for the development of Ivory in  accordance  with the Development  Plan.   Amgen  will  use  Commercially





50










Reasonable Efforts with respect to all other regulatory matters regarding Ivory in the Collaboration Scope including pricing, reimbursement and health technology assessments.   GSK will cooperate with Amgen, at its reasonable request, with respect to any regulatory matters related to Ivory in the Collaboration Scope.   Amgen will provide GSK with copies of Regulatory Filings and material communications with Governmental Authorities in the Collaboration Scope prior to submission within a reasonable amount of time to allow GSK to review and comment on such Regulatory Filings and communications, but not less than five (5) days, and Amgen will consider all comments and proposed revisions from GSK in good faith prior to submission. Notwithstanding the foregoing, if exigent action is required with respect to such Regulatory Filing or material communication, and Amgen reasonably believes it is not practicable to provide such Regulatory Filing or communication to GSK in  advance  of  submission  without  violating  Applicable  Law  or  causing  a material  delay  to  such  Regulatory  Filing,  communication  or  receipt  of Regulatory Approval, Amgen will instead provide such filing or communication to GSK as soon as reasonably practicable.   Amgen will consult with GSK regarding, and keep GSK informed of, the status of the preparation of all Regulatory Filings, Governmental Authority review of Regulatory Filings, and Regulatory Approvals made or obtained by it in the Collaboration Scope.


		
	10.1.2.
	Regulatory Meetings.  Amgen will consult with GSK reasonably in advance of the date of any anticipated meeting with a Governmental Authority in the Collaboration  Scope  and  will  consider  in  good  faith  any  timely recommendations made by GSK in preparation for such meeting.  Amgen will consider in good faith permitting GSK to attend particular meetings between Amgen and the applicable Governmental Authority that pertain to the Collaboration  Scope.     Where  Amgen  so  agrees,  it  will  request  that  the applicable Governmental Authority allow at least one (1) GSK representative to attend, as an observer, such meetings; provided, that the foregoing will not apply to informal meetings or teleconferences that are unscheduled or intended by the Governmental Authority to be between it and Amgen representatives only (such as interactions with EMEA rapporteurs).  Amgen will timely inform GSK of any such meetings.  GSK will strictly follow Amgen’s instructions with respect to any such meeting, and will not discuss the contents of any such meeting with any Governmental Authority except as required by Applicable Law or authorized by Amgen in writing.




		
	10.1.3.
	GSK Obligations.  Except as expressly provided in Section 10.1.1 (Regulatory Communications and Filings) GSK will cooperate with Amgen, at its request, with respect to any regulatory matters related to Ivory.  GSK will not without the consent of Amgen or unless so required by Applicable Law (and then only pursuant to the terms of this Section 10.1.1 (Regulatory Communication and Filings)),  correspond  or  communicate  with  any  Governmental  Authority, whether within the Collaboration Territory or otherwise, concerning Ivory or otherwise take any action with any Governmental Authority concerning any authorization or permission under which Ivory is sold or any application for the



51










same.  Furthermore, GSK will, immediately upon receipt of any communication from any Governmental Authority relating to Ivory, forward a copy (or written description, with respect to any oral communication) of the same to Amgen and respond to all inquiries by Amgen relating thereto.   If GSK is advised by its counsel  that  it  must  communicate  with  any  Governmental  Authority  with respect to Ivory or the activities under this Agreement, then GSK will so advise Amgen immediately and, if possible, provide to Amgen in advance for review a copy of any proposed written communication (or written description, with respect to any oral communication) with respect thereto.  GSK will comply with any and all reasonable direction of Amgen concerning any meeting or written or oral communication with any Governmental Authority; provided, that GSK will not take direction of Amgen that GSK reasonably believes is not in compliance with  Applicable  Law.    In  addition  to  the  foregoing: (i) unless  required  by Applicable Law, GSK will not disclose any information concerning any adverse drug experience to any Person or Governmental Authority without the prior consent of Amgen; (ii) GSK will utilize the global safety database maintained by Amgen as directed by Amgen from time-to-time; and (iii) Amgen will have the sole discretion to assess all adverse drug experiences and to determine whether any complaint or adverse drug experience must be reported to any Governmental Authority.


		
	10.1.4.
	Labeling  and  Packaging  Materials.    Amgen  will  have  sole  authority  and responsibility, and will use Commercially Reasonable Efforts to, seek and/or obtain any necessary governmental approvals of any labeling, package inserts or packaging for Ivory and Promotional Materials, and to determine whether the same requires governmental approval; provided, that Amgen will use Commercially Reasonable Efforts to obtain any Governmental Authority approval required to include the GSK Housemarks on the labeling, packaging and package inserts for Ivory in the Collaboration Scope within six (6) months of the  Effective Date.   All  filings and  communications  with  Governmental Authorities in connection therewith will remain under the control of Amgen. No labeling, package inserts, or packaging for Ivory may be used or distributed by GSK unless such labeling, package inserts or packaging has been approved in advance by Amgen.   GSK will not modify or alter any labeling, package inserts or packaging for Ivory, without the express prior approval of such modification or alteration by Amgen.  Amgen will provide GSK with prompt notice of, and copies of, any changes in the Ivory labeling, package inserts or packaging.




		
	10.1.5.
	Regulatory and Safety Information.  Each Party agrees to provide the other with all reasonable assistance and take all actions reasonably requested by the other Party that are necessary or desirable to enable the other Party to comply with any Applicable Law with respect to Ivory, including reporting obligations of Amgen related to Ivory.  Such assistance and actions will include, among other things, GSK keeping Amgen informed, commencing immediately upon notification of any action by, or notification or other information which it receives (directly or indirectly) from any Governmental Authority that: (i) raises any concerns regarding the safety or efficacy of Ivory; (ii) indicates or suggests



52










a potential liability for either Party to Third Parties arising in connection with Ivory; or (iii) is reasonably likely to lead to a recall or market withdrawal of Ivory.   Concurrently with entry into this Agreement, or promptly after the Effective Date of the Agreement, but not later than sixty (60) days thereafter, the Parties will enter into an agreement pertaining to safety, pharmacovigilance, product complaints and/or the like.


		
	10.2.
	Brand  Security  and  Anti-Counterfeiting.    The  Parties  will  establish  contacts  for communication regarding brand security issues and will each reasonably cooperate with the other with respect thereto.




		
	10.3.
	Product Technical Complaints; Recalls; Returns.




		
	10.3.1.
	Product Technical Complaints  If GSK (including any GSK sales representative Detailing  Ivory)  becomes  aware  of  any  Product  Technical  Complaint  (as defined below), GSK will submit a written report of such complaint to Amgen within one (1) business day of GSK so becoming aware (along with a sample of the Ivory product involved in the complaint, as soon as (and if) available).  GSK will not take any other action in respect of any such complaint without the consent of Amgen unless otherwise required by Applicable Law.   As used herein, “Product Technical Complaint” means: (i) any complaint that questions the purity, identity, potency or quality of Ivory, its packaging or labeling or the compliance  of  any  batch  of  Ivory  with  Applicable  Law;  (ii) any  complaint concerning Ivory being mistaken for, or Ivory’s labeling being applied to, another  article;  (iii) any  bacterial  contamination  or  significant  chemical, physical or other change or deterioration in Ivory; (iv) any failure of one (1) or more batches of Ivory to meet the specifications therefor in the applicable Regulatory Approval; or (v) any complaint or evidence of tampering with Ivory. Amgen will use Commercially Reasonable Efforts to address any such Product Technical Complaint with respect to Ivory in the Collaboration Scope.




		
	10.3.2.
	Recalls  or  Other  Corrective  Action.    Amgen  will  have  the  sole  right  to undertake, and will make all decisions with respect to, any recall, market withdrawals,  field  alerts  or  any  other  corrective  action (including letters to health care professionals) related to Ivory.   At Amgen’s request, GSK will provide reasonable assistance to Amgen in conducting such recall, market withdrawal or other corrective action in the Collaboration Territory.   Without prejudice   to   Amgen’s   indemnity   obligations   pursuant   to   Section   13.2 (Indemnity by Amgen), Amgen will be under no liability whatsoever to compensate GSK or make any other payment to GSK based on any decision to recall,  initiate  a  market  withdrawal,  issue  a  field  alert  or  take  any  other corrective action with respect to Ivory, unless such action results from Amgen’s failure to comply with the terms of this Agreement.




		
	10.3.3.
	Returns.   If any quantities of Ivory are returned to GSK, GSK will promptly notify Amgen and ship them to the facility designated by Amgen.  GSK, at its option, may advise the customer who made the return that Ivory has been returned to Amgen, but will take no other steps in respect of any return without



53






the consent of Amgen, except as may be expressly authorized by the relevant
Country Team.


		
	10.4.
	Clinical Trial Register.  Amgen will use Commercially Reasonable Efforts to publish the results and/or summaries of clinical trials relating to Ivory in the Collaboration Scope on a clinical trial register maintained by it and the protocols of clinical trials relating  to  Ivory  in  the  Collaboration  Scope  on  www.ClinicalTrials.gov  (or  an equivalent register in the Collaboration Scope, or as otherwise required by Applicable Law  or  Amgen’s  policies).    GSK  will  have  the  right  to  publish  results  and/or summaries (in the identical form as published by Amgen) if Amgen has already published in accordance with the foregoing sentence, or the JDC approves such publication.  The Parties will cooperate to establish timelines and procedures for JDC review of publications and presentations.




		
	11.
	CONFIDENTIALITY, PUBLICATIONS AND PRESS RELEASES




		
	11.1.
	Confidentiality;  Exceptions.     Except  to  the  extent  expressly  authorized  by  this Agreement or otherwise agreed in writing, the Parties agree that, during the Term and for five (5) years thereafter, the receiving Party will keep confidential and will not publish  or  otherwise  disclose  or  use  for  any  purpose  any  and  all  information  or materials related to the activities contemplated hereunder and furnished to it by the other Party pursuant to this Agreement (or in the case of GSK, that is created by or on behalf of GSK and owned by Amgen pursuant to Section 9.2 (Copyright Ownership)) that is identified by the disclosing Party as confidential, proprietary or the like or that the receiving Party has reason to believe is confidential based upon its own similar information (collectively, “Confidential Information”).  For clarity, GSK will have no right  to  and will  not  utilize  any  Confidential  Information  of Amgen  for  activities outside the Collaboration Scope or for activities related to products other than Ivory. Notwithstanding the foregoing, Confidential Information will not include any information to the extent that it can be established by written documentation by the receiving Party that such information:




		
	11.1.1.
	was obtained or was already known by the receiving Party or its Affiliates without obligation of confidentiality as a result of disclosure from a Third Party that the receiving Party did not know was under an obligation of confidentiality to the disclosing Party with respect to such information;




		
	11.1.2.
	was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party through no act or omission of the receiving Party or its Affiliates in breach of this Agreement;




		
	11.1.3.
	became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party or its Affiliates in breach of this Agreement; or




		
	11.1.4.
	was  independently  discovered  or  developed  by  the  receiving  Party  or  its Affiliates (without reference to or use of Confidential Information of the disclosing Party).




		
	11.2.
	Authorized Disclosure.   Except as expressly provided otherwise in this Agreement, each Party may use and disclose Confidential Information of the other Party solely as



54










follows: (i) as reasonably necessary in conducting the activities contemplated under this Agreement; (ii) with respect to Confidential Information generated in the course of the activities conducted hereunder, to the extent pertaining specifically to Ivory, for use by Amgen in connection with Ivory outside the Collaboration Scope or disclosure by Amgen to a partner, GSK or licensee for use with respect to Ivory outside the Collaboration Scope; (iii) to the extent such disclosure is to a Governmental Authority as reasonably necessary in filing or prosecuting patent, copyright and trademark applications in accordance with this Agreement, prosecuting or defending litigation in accordance with this Agreement, complying with applicable governmental regulations with respect to performance under this Agreement, filing Regulatory Filings, obtaining Regulatory Approval or fulfilling post-approval regulatory obligations for Ivory, or otherwise  required  by  Applicable  Law,  provided  that  if  a  Party  is  required  by Applicable Law to make any such disclosure of the other Party’s Confidential Information it will, except where impracticable for necessary disclosures (for example, in the event of medical emergency), give reasonable advance notice to the other Party of such disclosure requirement and, in the case of each of the foregoing exceptions pursuant to this subsection (iii), will use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed; (iv) to advisors (including lawyers and accountants) on a need to know basis in support of the purposes of this Agreement, in each case under appropriate confidentiality provisions or professional standards of confidentiality substantially equivalent to those of this Agreement; and (v) to the extent mutually agreed to by the Parties.  Neither Party will disclose Confidential Information of the other Party to its personnel or to an Affiliate except to the extent such personnel or Affiliate needs to know such information for the performance of such Party’s activities hereunder.


		
	11.3.
	Confidential Treatment of Terms and Conditions.  Neither Party will disclose the terms and conditions of this Agreement except that each Party has the right to disclose the terms and conditions of this Agreement under reasonable and customary obligations of confidentiality (but no less than equivalent obligations to those under which the disclosing Party would disclose its own confidential information of similar type): (i) if required by Applicable Law (including disclosure of a redacted version of this Agreement in a relevant SEC filing); (ii) to Governmental Authorities with authority over such Party that request to review this Agreement in connection with a review, audit or investigation of the operations of such Party by such authority (and provided that review of the terms of this Agreement are reasonably pertinent to such review, audit or investigation); and (iii) to its attorneys and accountants in support of the purposes of this Agreement.  Notwithstanding the foregoing, with respect to complying with the disclosure requirements of any Governmental Authority in connection with any required filing of this Agreement, the Parties will consult with one another concerning which terms of this Agreement will be requested to be redacted in any public disclosure of the Agreement, and in any event each Party will seek reasonable confidential treatment for any public disclosure by any such Governmental Authority.




		
	11.4.
	Press Releases.  Notwithstanding Section 11.3 (Confidential Treatment of Terms and Conditions), the Parties will issue a joint press release to announce the execution of this Agreement, which is attached hereto as the Press Release Schedule and is for use in responding  to  inquiries  about  the  Agreement  and  will  agree  on  the  timing  (in



55










accordance with Applicable Law) and method for issuing such press release and any media briefings; thereafter, GSK and Amgen may each disclose to Third Parties (including media interviews and disclosures to financial analysts) the information contained in such press release (but only such information) without the need for further approval by the other, provided that such information is still accurate.  Each Party will have the right to issue additional press releases and disclosures in regards 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 Law).   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.


		
	11.5.
	Prior Agreement.  This Agreement supersedes the Confidential Disclosure Agreement between the Parties dated January 28, 2009, including any written requests thereunder (the “Prior Agreement”) with respect to information disclosed thereunder relating to Ivory and activities related thereto.   All confidential information exchanged between the Parties under the Prior Agreement will be deemed Confidential Information of the disclosing Party disclosed hereunder and will be subject to the terms of this Agreement.




		
	11.6.
	Publications and Program Information.  Except as permitted pursuant to Section 10.4 (Clinical Trial Register), or as agreed by the JBT or JDC, Amgen will have the sole right to publish and make scientific presentations with respect to Ivory, and to issue press releases (except with respect to the terms of this Agreement, which is governed by Section 11.4 (Press Releases) or make other public disclosures regarding Ivory (including with respect to its development, commercialization and regulatory matters), and GSK will not do so without Amgen’s prior written consent.  Amgen will keep the relevant   committee   or  team  informed   of  its   general   publication  strategy   and presentation calendar.  In addition, Amgen will deliver to GSK a copy of any proposed written publication or outline of presentation with respect to Ivory in the Collaboration Scope in advance of submission for publication or presentation at least thirty (30) days in advance of submission (or, where a copy of such publication or presentation is not available at such time, a draft or outline of such publication or a description of such presentation), and GSK will have the right to: (i) require a delay in submission of not more than sixty (60) days to enable patent applications protecting each Party’s rights in such information to be filed; and (ii) prohibit disclosure of any of its Confidential Information in any such proposed publication or presentation.   Publications and presentations  will  be  subject  to  policies  established  by  the  Patent  Coordinators  to ensure appropriate protection of intellectual property rights.




		
	11.7.
	Attorney-Client Privilege.  Neither Party is waiving, nor will be deemed to have waived or diminished, any of its attorney work product protections, attorney-client privileges or similar protections and privileges recognized under the Applicable Law of any jurisdiction as a result of disclosing information pursuant to this Agreement, or any of its Confidential Information (including Confidential Information related to pending or threatened litigation) to the receiving Party, regardless of whether the disclosing Party has asserted, or is or may be entitled to assert, such privileges and protections.   The



56










Parties may become joint defendants in proceedings to which the information covered by such protections and privileges relates and may determine that they share a common legal interest in disclosure between them that is subject to such privileges and protections, and in such event, may enter into a joint defense agreement setting forth, among other things, the foregoing principles but are not obligated to do so.


		
	11.8.
	Injunctive Relief.  Given the nature of the Confidential Information and the competitive damage that may result to a Party upon unauthorized disclosure, use or transfer of its Confidential Information to any Third Party, the Parties agree that monetary damages may not be a sufficient remedy for any breach of this Article 11 (Confidentiality, Publications and Press Releases).  In addition to all other remedies, a Party is entitled to seek specific performance and injunctive and other equitable relief (without the need to post  a  bond)  as  a  remedy  for  any  breach  or threatened  breach  of  this  Article  11 (Confidentiality, Publications and Press Releases).




		
	11.9.
	Additional Permitted Disclosure.   GSK will have the right to inform Roche of its obligation to Segregate the Ivory program from the BonvivaTM program pursuant to Section 8.4 (Pre-Effective Date Programs).




		
	12.
	REPRESENTATIONS AND WARRANTIES




		
	12.1.
	Mutual Representations and Warranties.   Each of the Parties hereby represents and warrants, as of the Effective Date to the other Party as follows:




		
	12.1.1.
	It  is  duly  organized  and  validly  existing  under  the  Applicable  Law  of  its jurisdiction of incorporation and it has full corporate power and authority and has taken all corporate action necessary to enter into and perform this Agreement;




		
	12.1.2.
	This Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms.   The execution, delivery and performance of the Agreement, and compliance with its terms and provisions, and the consummation of the transaction contemplated hereby, by such Party will not materially conflict, interfere or be inconsistent with, result in any material breach of or constitute a material default under, any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor to its knowledge violate any Applicable Law.   The person or persons executing this Agreement on such Party’s behalf have been duly authorized to do so by all requisite corporate action;




		
	12.1.3.
	To  its  knowledge,  no  government  authorization,  consent,  approval,  license, exemption of or filing or registration with any court or Governmental Authority or under Applicable Law, is or will be necessary for, or in connection with, the transaction  contemplated  by  this  Agreement  or  any  other  agreement  or instrument executed concurrently herewith, or (except for Regulatory Approvals, licenses, clearances and the like necessary for the commercialization, research, development, manufacture, sales or marketing of pharmaceutical products and except for any required filing with the United States Securities and Exchange Commission) for the performance by it of its obligations under this Agreement;



57










		
	12.1.4.
	It  has  not  been  debarred  or  the  subject  of  debarment  proceedings  by  any Governmental Authority;




		
	12.1.5.
	To  its  knowledge  it  and  its  Affiliates  have  not  violated  any  applicable anticorruption or anti-bribery law or regulation, including the U.S. Foreign Corrupt Practices Act of 1977, as amended, or the regulations promulgated thereunder (collectively, “Anticorruption Laws”);




		
	12.1.6.
	It has established and maintains reasonable internal controls intended to ensure compliance with Anticorruption Laws, including reasonable reporting requirements; and




		
	12.1.7.
	It has not granted any right to any Third Party relating to any intellectual property or proprietary right licensed, granted or assigned by it to the other Party hereunder that conflicts with the rights licensed, granted or assigned to the other Party hereunder.




		
	12.2.
	Amgen  Representations  and  Warranties.    In  addition  to  the  representations  and warranties set forth in Section 12.1 (Mutual Representations and Warranties) Amgen hereby represents and warrants to GSK that, except as would not be expected to have a material adverse effect on the activities of the Parties hereunder, as a whole, as of the Effective Date:




		
	12.2.1.
	To the knowledge of Amgen’s Patent Attorneys, except as disclosed on the Amgen Disclosures Schedule, Amgen has not received written notice from any Third Party that any issued and enforceable Patent of such Third Party would be infringed by the importation, manufacture, distribution, marketing or sale of Ivory (except, in each case, where Amgen may have since such time obtained a license to the relevant Patent);




		
	12.2.2.
	Except as disclosed on the Amgen Disclosures Schedule, Amgen is the sole owner, free and clear of any encumbrance, of all right, title and interest in the Product Trademarks and Ivory Intellectual Property or otherwise has the right to grant to GSK the rights to such trademarks and intellectual property as set forth in this Agreement;




		
	12.2.3.
	Except as disclosed on the Amgen Disclosures Schedule, to the knowledge of Amgen’s Patent Attorneys, no issued Patent owned or controlled by Amgen or its Affiliates and claiming Ivory Intellectual Property, including the use or manufacture of Ivory, is invalid or unenforceable;




		
	12.2.4.
	Except as disclosed on the Amgen Disclosures Schedule, to the knowledge of Amgen’s Patent Attorneys, Amgen has not received written notice that any Third Party is engaged in commercial activities that infringe the Ivory Intellectual Property in the Collaboration Scope in a manner that could reasonably be believed to have a material adverse effect on the activities to be conducted under this Agreement or the sales of Ivory in the Collaboration Scope;




		
	12.2.5.
	The development of Ivory in the Collaboration Scope by or on behalf of Amgen has been conducted in compliance in all material respects with all Applicable Laws, and Amgen has no knowledge that any of its Third Party contractors has



58










developed Ivory in a manner that does not comply in all material respects with all Applicable Laws;


		
	12.2.6.
	To Amgen’s knowledge, there is no pending product liability action in relation to Ivory.   For the purposes of this Section 12.2.6, “product liability action” does not include claims for reimbursement of medical expenses for the treatment of any injury or illness related to administration of Ivory in or participation in a clinical study or trial; and




		
	12.2.7.
	As of the Effective Date, Amgen and its Affiliates have made available to GSK the information referenced in the Diligence Materials Schedule, in response to GSK’s reasonable inquiries in connection with GSK’s due diligence related to Ivory in the Collaboration Scope (some of which was provided in summary form).




		
	12.3.
	Amgen Covenants. Amgen hereby covenants to GSK that:




		
	12.3.1.
	It will not require or request that GSK disclose to Amgen or its Affiliates or use in the performance of its activities hereunder, confidential information of Roche where Amgen knows such disclosure or use to be in violation of the Roche Agreement; and




		
	12.3.2.
	Amgen understands its rights and obligations under this Agreement, and has and will at all times during the Term maintain sufficient resources to fully and diligently perform its obligations hereunder in accordance with the terms and provisions hereof.




		
	12.4.
	GSK Representations and Warranties.  In addition to the representations and warranties set forth in Section 12.1 (Mutual Representations and Warranties), GSK hereby represents and warrants to Amgen that, except as would not be expected to have a material adverse effect on the activities of the Parties hereunder, as a whole, as of the Effective Date:




		
	12.4.1.
	GSK’s performance of its activities hereunder will not cause a material breach of the Roche Agreement, or disrupt or interfere in any material way with the activities contemplated under the Roche Agreement;




		
	12.4.2.
	GSK has sufficient resources to perform its obligations and activities under the Roche Agreement to the same proficiency and dedication subsequent to its entry into this Agreement as prior to its entry into this Agreement, taking into account GSK’s concurrent diligent performance of its obligations hereunder; and




		
	12.4.3.
	GSK  has  not  disclosed  to  Amgen  or  any  of  its  Affiliates  any  confidential information of Roche received by GSK under the Roche Agreement.




		
	12.5.
	GSK Covenants.  GSK hereby covenants to Amgen that:




		
	12.5.1.
	GSK understands its rights and obligations under this Agreement, and has and will at all times during the Term maintain sufficient resources to fully and diligently perform its obligations hereunder in accordance with the terms and provisions hereof; and



59










		
	12.5.2.
	It will not take any action under or in connection with this Agreement that would or would be reasonably likely to materially breach, disrupt or interfere with the Roche Agreement or otherwise materially adversely impact its performance thereunder, including the disclosure or use of any confidential information of Roche received by GSK under the Roche Agreement.




		
	12.6.
	Disclaimer  of  Warranties.    EXCEPT  AS  SET  FORTH  IN  THIS  ARTICLE  12 (REPRESENTATIONS AND WARRANTIES), GSK AND AMGEN EXPRESSLY DISCLAIM    ANY   AND   ALL   REPRESENTATIONS   AND   WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO THE COLLABORATION,    IVORY      INTELLECTUAL      PROPERTY,      AMGEN HOUSEMARKS,    GSK   HOUSEMARKS,   PRODUCT   TRADEMARKS,   THIS AGREEMENT, OR ANY OTHER SUBJECT MATTER RELATING TO THIS AGREEMENT, INCLUDING ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OR NONINFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS.




		
	12.7.
	Limitation   of   Liability.      NOTWITHSTANDING   ANY   OTHER   PROVISION CONTAINED HEREIN, OTHER THAN TO THE EXTENT RESULTING FROM A PARTY’S BREACH OF ARTICLE 8 (DISTRACTING PRODUCTS) OR SECTION 11.1 (Confidentiality; Exceptions), IN NO EVENT WILL GSK OR AMGEN 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  EITHER  PARTY  TO  INDEMNIFY  THE  OTHER  PARTY FROM AND AGAINST THIRD PARTY CLAIMS UNDER SECTION 13.1 (INDEMNITY BY GSK), SECTION 13.2 (INDEMNITY BY AMGEN) OR SECTION 13.3 (SPECIFIC INDEMNITY).




		
	12.8.
	Covenants. Each Party hereby covenants to the other Party that, during the Term:




		
	12.8.1.
	it will not grant any right to any Third Party relating to any intellectual property or proprietary right licensed or assigned by it to the other Party hereunder that conflicts with the rights granted to the other Party hereunder;




		
	12.8.2.
	it  will  not  knowingly  use  in  connection  with  the  research,  development, manufacture or commercialization to take place pursuant to this Agreement any employee, consultant or investigator that has been debarred or the subject of debarment proceedings by any regulatory agency; and




		
	12.8.3.
	it will comply with all Applicable Law with respect to their performance of its rights,    duties     and     obligations     under     this     Agreement,     including commercialization, manufacturing, research and development and regulatory activities.



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	13.
	INDEMNIFICATION AND INSURANCE




		
	13.1.
	Indemnity by GSK.  Subject to the remainder of this Article 13 (Indemnification), GSK will defend, indemnify, and hold harmless Amgen, its Affiliates, and their respective directors, officers, employees, agents and representatives (collectively, “Amgen Indemnitees”), at GSK’s cost and expense, from and against any and all liabilities, losses, costs, damages, fees or expenses (including reasonable legal expenses and attorneys’ fees incurred by or on behalf of any of the indemnitees until such time as the indemnification obligation is acknowledged and assumed hereunder with respect to the applicable  claim)  (collectively,  “Losses”)  arising  out  of  any  Third  Party  Claims brought against any Amgen Indemnitee to the extent such Losses result from: (a) the negligence or willful misconduct of GSK or its Affiliates (or any employees, agents or representatives of any of them (other than Amgen or its Affiliates)) in performing under this Agreement; or (b) a breach by GSK of this Agreement, including the failure of GSK’s representations or warranties in Article 12 (Representations and Warranties) to be true in any material respect but excluding such Losses to the extent they arise from (w), (x), (y) or (z) below in Section 13.2 (Indemnity by Amgen).




		
	13.2.
	Indemnity by Amgen.   Subject to the remainder of this Article 13 (Indemnification), Amgen will defend, indemnify, and hold harmless GSK, its Affiliates, and their respective  directors,  officers,  employees,  agents  and  representatives  (collectively, “GSK Indemnitees”), at Amgen’s cost and expense, from and against any and all Losses arising out of any Third Party Claims brought against any GSK Indemnitee to the extent such Losses: (w) result from personal injury (regardless of theory of liability) arising out of administration of Ivory in clinical trials conducted by or on behalf of Amgen or its Affiliates and for which dosing of patients was completed before the Effective Date; (x) result from acts or omissions of any Amgen Indemnitee with respect to Ivory outside the Collaboration Scope (other than activities conducted for the benefit of the Collaboration Scope, or within the Expansion Scope or for the benefit of the Expansion Scope unless otherwise provided in the Expansion Agreement), including the  development,  manufacturing,  marketing,  advertising,  promotion,  distribution, selling, storage, handling or usage of Ivory outside the Collaboration Scope anywhere in the world; (y) result from the negligence or willful misconduct of Amgen or its Affiliates (or any employees, agents or representatives of any of them (other than GSK or  its  Affiliates)):  (i)  in  performing  under  this  Agreement;  or  (ii)  in  performing activities with respect to Ivory prior to the Effective Date of this Agreement; or (z) result from a breach by Amgen of this Agreement, including the failure of Amgen’s representations or warranties in Article 12 (Representations and Warranties) to be true in any material respect, but excluding such Losses to the extent they arise from Section 13.1(a), (b) or (c).




		
	13.3.
	Specific  Indemnity.     GSK  will  defend,  indemnify,  and  hold  harmless  Amgen Indemnitees, at GSK’s cost and expense, from and against any and all Losses arising out of any Roche Claim.  Notwithstanding the foregoing or anything in this Agreement to the contrary, Amgen will be entitled to be indemnified by GSK under this Section 13.3 (Specific Indemnity) with respect to any Loss only to the extent Amgen is not indemnified with respect to such Loss pursuant to Section 13.1 (Indemnity by GSK),



61










and such Losses will not be considered Collaboration Losses and will not be charged to the Collaboration Profit (Loss).


		
	13.4.
	Claim for Indemnification.  Whenever any Third Party Claim or Loss arises for which a GSK Indemnitee or an Amgen Indemnitee (the “Indemnified Party”) may seek indemnification under this Article 13 (Indemnification), the Indemnified Party will promptly notify the other Party (the “Indemnifying Party”) of the Third Party Claim or Loss and, when known, the facts constituting the basis for the Third Party Claim; provided that the failure by an Indemnified Party to give such notice or to otherwise meet its obligations under this Section 13.4 (Claim for Indemnification) will not relieve the Indemnifying Party of its indemnification obligation under this Agreement except and only to the extent that the Indemnifying Party is actually prejudiced as a result of such failure.  The Indemnifying Party will have exclusive control of the defense and settlement of all Third Party Claims for which it is responsible for indemnification and will assume defense thereof at its own expense promptly upon notice of such Third Party Claim.   The Indemnified Party will not settle or compromise any Third Party Claim for which it is entitled to indemnification without the prior written consent of the Indemnifying Party, unless the Indemnifying Party is in breach of its obligation to defend hereunder.  In no event will the Indemnifying Party settle any Third Party Claim without the prior written consent of the Indemnified Party if such settlement does not include  a  complete  release  from  liability  on  such  Third  Party  Claim  or  if  such settlement would involve undertaking an obligation by the Indemnified Party other than the payment of money, would bind or impair the Indemnified Party, or includes any admission of wrongdoing by the Indemnified Party or that any intellectual property or proprietary right of the Indemnified Party is invalid or unenforceable.  The Indemnified Party  will  reasonably  cooperate  with  the  Indemnifying  Party  at  the  Indemnifying Party’s  expense  and  will  make  available  to  the  Indemnifying  Party  reasonably requested information under the control of the Indemnified Party, which information will be subject to Article 11 (Confidentiality, Publications and Press Releases).   The Indemnifying Party will permit the Indemnified Party to participate in (but not to control) the Third Party Claim through counsel of its choosing to the extent it has the ability to do so (at the Indemnified Party’s expense).  Notwithstanding the foregoing, the  Indemnified  Party  will  have  the  right  to  employ  separate  counsel  at  the Indemnifying Party’s expense and to control its own defense of the applicable Third Party Claim if: (i) there are or may be legal defenses available to the Indemnified Party that are different from or additional to those available to the Indemnifying Party; or (ii) in the reasonable opinion of counsel to the Indemnified Party, a conflict or potential conflict exists between the Indemnified Party and Indemnifying Party that would make such separate representation advisable; provided that, in no event will the Indemnifying Party be required to pay fees and expenses under this sentence for more than one (1) firm of attorneys in any jurisdiction in any one (1) legal action or group of related legal actions.




		
	13.5.
	Defense of Third Party Claims.  Except as otherwise provided in Section 13.4 (Claim for Indemnification), each Party (such Party referred to as the “Defending Party”) will have the sole right, but not the obligation, to defend against any Third Party Claims made against it with respect to its activities hereunder.  Each Party will notify the other Party (the “Assisting Party”) as promptly as practicable if any Third Party Claim is



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commenced or threatened against it, including any Infringement Claim or any Roche Claim.  The Assisting Party will reasonably assist the Defending Party and cooperate in any such litigation at Defending Party’s reasonable request (and the Defending Party will reimburse the Assisting Party’s reasonable costs incurred in connection with such cooperation (subject to Section 6.1.1.4 and 6.1.2.11, to the extent applicable)).    The Defending Party will seek and reasonably consider, but is not obligated to follow, the Assisting Party’s comments before determining the strategy for such matter.  Without limiting the foregoing, the Defending Party will keep the Assisting Party advised of all material communications, actual and prospective filings or submissions regarding such action, and will provide the Assisting Party copies of and an opportunity to review and comment on any such communications, filings and submissions; provided, that each Party  will  have  the  right  to  redact  from  any  information  disclosed  to  the  other hereunder any information relating to a product other than Ivory or relating to the manufacture of Ivory.  The Defending Party will control the defense and/or settlement of Third Party Claims at its own expense (subject to Section 6.1.1.4 and 6.1.2.11, to the extent applicable) with counsel of its choice.  The Assisting Party will have the right to participate in the defense and/or settlement of such Third Party Claim at its own expense (subject to Section 6.1.1.4 and 6.1.2.11, to the extent applicable) with counsel of its choice.  The Defending Party will not settle a Third Party Claim without the prior written consent of the other Party (such consent not to be unreasonably withheld), unless such settlement: (i) includes a complete release from liability; or (ii) does not: (a) involve undertaking an obligation by the non-controlling Party other than the payment of money that would be indemnified hereunder; (b) bind or impair the non- controlling Party; or (c) include any admission of wrongdoing by the non-controlling Party.  In the event that a Third Party Claim is brought against both of the Parties (a “Joint Claim”), then the Parties will determine whether to defend against such Joint Claim, which of the Parties should be the Defending Party or whether the Parties should jointly control such defense and the strategy for such defense.   If the Parties determine that there will be one Defending Party for a Joint Claim, then the Assisting Party will have the right to participate in the defense of such Joint Claim through counsel, and at its own expense (subject to Section 6.1.1.4 and 6.1.2.11, to the extent applicable) of its choosing to the extent it has the ability to do so, and may control its own defense of the Joint Claim if there are or may be legal defenses available to the Assisting Party that are different from or additional to those available to the Defending Party, or in the reasonable opinion of counsel to the Assisting Party, a conflict or potential conflict exists between the Assisting Party and Defending Party that would make such separate representation advisable.  In the case of an Infringement Claim, the coordination and cooperation set forth in this Section 13.5 (Defense of Third Party Claims) will be accomplished via the Patent Coordinators.  This Section 13.5 (Defense of  Third  Party  Claims)  will  not  apply  to  employment  or  similar  personnel-related claims.


		
	13.6.
	Insurance.  Each of the Parties will, at their own respective expense (and not subject to cost sharing hereunder) procure and maintain during the Term, insurance policies adequate to cover their obligations hereunder and consistent with the normal business practices of prudent pharmaceutical companies of similar size and scope (or reasonable



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self-insurance sufficient to provide materially the same level and type of protection). Such insurance will not create a limit to either Party’s liability hereunder.


		
	14.
	TERM AND TERMINATION




		
	14.1.
	Term.  This Agreement will become effective on the Effective Date and will terminate at the end of the Term unless and until sooner terminated pursuant to any provision of this Agreement.




		
	14.2.
	Termination for Breach.




		
	14.2.1.
	In the event of a material breach of this Agreement, the non-breaching Party will have the right to terminate this Agreement (either as a whole or in the country or countries in which such breach occurred, at the terminating Party’s option) by written notice to the breaching Party, which notice will specify the nature of such breach in reasonable detail.   Such termination will become effective on the date specified in the notice (which will not be earlier than sixty (60) days after the delivery thereof to the breaching Party or, in the case of a failure to pay amounts due hereunder, thirty (30) days) unless, during the sixty (60) day (or thirty (30) day) period after delivery of such notice to the breaching Party, the breaching Party has cured such breach to the reasonable satisfaction of the non-breaching Party.




		
	14.2.2.
	Notwithstanding the provisions of Section 14.2.1, the following will apply in the event of multiple breaches by the same Party: (i) in the event of three (3) material breaches of this Agreement by the same Party within a thirty-six (36) month period, the non-breaching Party will have the right to terminate this Agreement by written notice to the breaching Party, which notice will specify the nature of such third breach in reasonable detail, effective (regardless of whether such third breach is cured) as of the date specified in such notice (which will not be earlier than thirty (30) days from receipt thereof by the breaching Party), and (ii) if a Party commits at least two (2) material breaches of this Agreement and such breaches are with respect to the same obligation or activity hereunder, then the non-breaching Party will have the right, but not the obligation, to call a special meeting of the JDC with respect to development breaches or the JSC with respect to any other breach (a “Special Meeting”), by written notice to the breaching Party.  Such notice will state with particularity the obligations that the non-breaching Party believes have not been satisfied and the basis for such belief.  The Special Meeting will be convened within ten (10) business days of the breaching Party’s receipt of such notice.   At the Special Meeting, the JSC or JDC, as applicable, will discuss the non-breaching Party’s concerns, the breaching Party’s efforts in such area of concerns and any additional actions the breaching Party should take to alleviate the non-breaching Party’s concerns.  The JSC or JDC, as applicable, will develop a plan describing the actions that the Parties reasonably believe the breaching Party should take to meet its applicable obligations under the Agreement (the “Remediation Plan”); provided, that the Remediation Plan may provide that the non-breaching Party will assume responsibility for such obligation or activity and the breaching Party will cooperate with the non-breaching Party to effect such transition to the



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non-breaching Party.  The applicable Party will perform the actions described in such  Remediation  Plan  in  accordance  with  the  timelines,  if  any,  set  forth therein.  For the avoidance of doubt, if the non-breaching Party chooses not to request a Special Meeting, then such Party may proceed in accordance with Section 14.2.1.


		
	14.3.
	Termination  for  Insolvency.    Either  Party  will  have  the  right  to  terminate  this Agreement immediately upon written notice, if: (i) the other Party becomes insolvent; (ii)  the  other  Party  files a  petition  in  bankruptcy,  or  if  an  involuntary  petition  in bankruptcy  is  filed  against  the  other  Party  and  such  involuntary  petition  is  not dismissed within seventy-five (75) days and the other Party (a) fails to assume this Agreement in any such bankruptcy proceeding within thirty (30) days after filing or (b) assumes and assigns this Agreement to a Third Party, or (iii) a receiver or guardian has been appointed for the other Party who is not discharged within seventy-five (75) days after appointment.




		
	14.4.
	Early Termination by Amgen.  Amgen will have the right to terminate this Agreement by at least eighteen (18) months prior written notice to GSK (a “Termination Buyout Notice”), such termination to be effective no sooner than January 1, 2021 with respect to either: (i) all countries in the Collaboration Territory; or (ii) one, any or all of the Russian Federation, Mexico, Australia and/or New Zealand.  In the event of any such termination, Amgen will pay GSK the fair market value of GSK’s remaining interest so terminated (i.e., a one-time payment of the risk-adjusted net present value of the net profits GSK would be expected to receive from such terminated interest over the remainder of the Term (including, for the avoidance of doubt, the Tail Period) in the event the Agreement had not been so terminated with respect thereto (a “Termination Buyout Payment”) (but not less than zero)).   Within forty-five (45) days following Amgen’s provision of the Termination Buyout Notice, the Parties will meet and negotiate the amount of such Termination Buyout Payment.  If the Parties agree on the amount of the Termination Buyout Payment within ninety (90) days following the provision  of  the  Termination  Buyout  Notice,  then  Amgen  will  pay  GSK  the Termination Buyout Payment within thirty (30) days following the effective date of such termination.  If the Parties fail to agree on an amount of a Termination Buyout Payment within ninety (90) days following the provision of the Termination Buyout Notice, then GSK will propose to Amgen in writing four (4) Third Party valuators (two (2) top-tier, internationally-recognized investment banks and two (2) top-tier, internationally recognized accounting firms) with relevant expertise to determine the appropriate amount for the Termination Buyout Payment.  Within ten (10) days of the receipt of such proposal, Amgen will select one (1) of the proposed valuators by written notice to GSK and the Parties will engage the selected valuator to determine the amount of the Termination Buyout Payment, at Amgen’s sole cost.   Each of the Parties will provide to such valuator such information as it deems pertinent for the valuation and any information requested by such valuator.  Such selected valuator will promptly (and in any event within forty-five (45) days after the selection of such valuator) determine the  Termination  Buyout  Payment  amount  and  provide  notice  of  the  Termination Buyout Payment amount (and underlying assumptions and methodology) to each of the Parties. Amgen will have thirty (30) days from receipt of notice of the Termination Buyout Payment amount from the valuator to provide written notice to GSK of whether



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or not it intends to proceed with the termination as specified in the Termination Buyout Notice  previously  provided  pursuant  to  this  Section  14.4  (Early  Termination  by Amgen) at the Termination Buyout Payment amount specified by the valuator.  Should Amgen specify in such notice that it intends to proceed with the termination pursuant to the Termination Buyout Notice, then the Termination Buyout Notice will be effective as of the date specified in the original Termination Buyout Notice and Amgen will pay GSK the Termination Buyout Payment within thirty (30) days following the effective date of such termination. Should Amgen specify by written notice that it does not desire to proceed with such termination pursuant to the Termination Buyout Notice at the Termination   Buyout   Payment   amount   established   by   the   valuator,   then   such Termination Buyout Notice will be void and this Agreement will not terminate pursuant to this Section 14.4 (Early Termination by Amgen).


		
	14.5.
	Termination Discussion.  If the sales of Ivory during any three (3) year period are less than fifty (50%) percent of the total amount forecast for such period (as set forth in the Sales Forecast Schedule) (or if either Party reasonably determines that facts and circumstances pertaining at any time during the Term indicate a very high likelihood that the foregoing will occur, including by reason of label or other access limitations or safety events), then the Parties will meet and discuss whether it may be appropriate to terminate this Agreement, provided that no such termination will be effective unless expressly agreed in writing by the Parties.




		
	14.6.
	Valid Safety Issue.   Either Party may terminate this Agreement immediately upon written notice following either: (i) the voluntary withdrawal by Amgen of Ivory from any country in the Collaboration Territory as a result of a final decision by Amgen after discussion at the CRC, that Ivory is harmful under normal conditions of use or the risk- benefit balance is not positive under normal conditions of use; (ii) the voluntary withdrawal by Amgen of Ivory for a period of two hundred (200) consecutive days from any country in the Collaboration Territory as a result of a decision by Amgen after discussion at the CRC, that Ivory is harmful under normal conditions of use or the risk- benefit  balance  is  not  positive  under  normal  conditions  of  use;    (iii)  the  second complete recall by Amgen of Ivory from any country in the Collaboration Scope within a two (2) year period as a result of a determination by Amgen after discussion at the CRC, that Ivory is harmful under normal conditions of use or the risk-benefit balance is not positive under normal conditions of use; (iv) the final decision to withdraw Regulatory Approval of Ivory with respect to the Collaboration Field by the European Commission (or a successor thereto) as a result of the decision that Ivory is harmful under normal conditions of use or the risk-benefit balance is not positive under normal conditions of use; or (v) the suspension of the Regulatory Approval of Ivory with respect to the Collaboration Field by the European Commission (or a successor thereto) for a period of more than two hundred  (200) consecutive  days as a result of bona fide concerns that Ivory is harmful under normal conditions of use or the risk-benefit balance is not positive under normal conditions of use or is unsafe for administration to humans (with respect to each of the foregoing (i) through (v), not including any such occurrence due to manufacturing or distribution errors, or product tampering) (any of the foregoing, a “Valid Safety Issue”).  To be effective, such notice must be given no later than thirty (30) days following the notification by Amgen that such Valid Safety Issue has occurred.



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	14.7.
	Failure to Supply.  GSK may terminate this Agreement on thirty (30) days prior written notice if Amgen is unable to supply for reasons other than Force Majeure, at least sixty- six percent (66%) of the lower of: (i) the then-current monthly forecast requirements for Ivory in the Collaboration Scope as a whole; and (ii) the actual demand for Ivory in the Collaboration Scope as a whole, in each case for each of six (6) consecutive calendar months.  To be effective, such notice must be given no later than thirty (30) days following the sooner of notification by Amgen or GSK otherwise becoming aware that such failure to supply has occurred.




		
	14.8.
	Termination for Challenge.  Either Party will have the right to terminate this Agreement by written notice to the other Party, if such other Party, its Affiliates or licensees bring or join any challenge to the validity or enforceability of (i) if Amgen is the challenging Party, any Know-How or Patents licensed to Amgen pursuant to Section 9.5 (License Grant by GSK) (including GSK Inventions); and (ii) if GSK is the challenging Party, any Ivory Intellectual Property (or any intellectual property corresponding to any such Ivory Intellectual Property outside the Collaboration Scope).   Notwithstanding the foregoing, nothing in this Section 14.8 (Termination for Challenge) will either: (i) prevent either Party from asserting any defense or counterclaim in an action for infringement of intellectual property, brought against such Party or its Affiliates, or any Third Party that such Party or any of its Affiliates is obligated to indemnify, or responding in any other manner to such an action for infringement; or (ii) allow a Party to terminate this Agreement in the event the other Party asserts any such defense or counterclaim or otherwise responds in any such action for infringement.




		
	14.9.
	Effects  of  Expiration  or  Termination    Upon  the  expiration  or  termination  of  this


Agreement for any reason, the following will apply:


		
	14.9.1.
	Accrued Obligations.   Expiration or termination of this Agreement for any reason will not release either Party from any liability (including any payment obligations) that, at the time of such expiration or termination, has already accrued to the other Party or which is attributable to activities prior to such expiration or termination.




		
	14.9.2.
	Promotion Rights; Licenses.  Except as set forth in Section 14.10 (Transition), upon  the  expiration  or  termination  of  this  Agreement:  (i) GSK’s  right  to promote Ivory in the Collaboration Scope will terminate; (ii) all licenses to GSK hereunder  will  terminate;  and  (iii) GSK  will  immediately  cease  all  of  its promotional and marketing activities for Ivory in the Collaboration Territory and discontinue all use of Amgen Housemarks and Product Trademarks. Amgen’s right to use the GSK Housemarks pursuant to Section 9.11.3.2 will survive expiration or termination of the Agreement until such time as any existing inventory of labeling, package inserts or outserts, monographs or packaging materials or Promotional Materials for Ivory in the Collaboration Territory that contain the GSK Housemarks have been depleted.




		
	14.9.3.
	Product  Data  and  Amgen  Confidential  Information.    GSK  will  promptly transfer to Amgen, at no cost, copies of all data, reports, records and materials in its possession or control that relate to Ivory (“Product Data”).  Such Product Data will be in electronic form reasonably usable by Amgen and, if reasonably



67










necessary in connection with Amgen’s (or its designee’s) further commercialization, development or exploitation of Ivory in the Collaboration Territory, will include original hardcopies or duplicate copies thereof, as required.   In addition (without limiting Section 9.2 (Copyright Ownership; Certain Confidential Information), all Product Data generated by or under authority  of GSK  hereunder  during  the  term of  the  Agreement,  that  solely pertains to Ivory (or, where such Product Data pertain to Ivory as well as any other 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 above), and Amgen will have the unrestricted right to use and disclose all Product Data following termination of this Agreement.  In addition, GSK will promptly return to Amgen, or destroy at Amgen’s request, 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 Law; 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).


		
	14.9.4.
	Return of Samples and Materials.   GSK will promptly return to Amgen, or destroy  at  Amgen’s  request  (and  certify  such  destruction  to  Amgen),  all Samples, Promotional Materials, sales training materials and any other documents, or materials primarily intended for use in commercialization of Ivory in the Collaboration Territory.




		
	14.9.5.
	Assignment of Filings and Registrations.  GSK will, 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 Regulatory Filings and Regulatory Approvals in the Collaboration Territory related to Ivory that are in GSK’s name (if any), and all trademark and copyright registrations related to Ivory (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 herein or agreed in writing between the Parties.




		
	14.9.6.
	Survival.    Articles  5  (Up-Front  Payments  and  Milestones)  (with  respect  to periods prior to expiration or termination), 6 (Profit/Expense Sharing) (with respect to periods prior to expiration or termination), 7 (Payments) (with respect to periods prior to expiration or termination), 8 (Distracting Products) (only with respect to such continuing periods as expressly referenced in such Article), 13 (Indemnification and Insurance) (with respect to periods prior to expiration or  termination),  and  16  (Miscellaneous)   and  Sections 3.10  (Promotional Materials) (with respect to the termination of use of and destruction of existing Promotional Materials), 3.11 (Detailing Reports and Audit Rights) (with respect to periods prior to expiration or termination), 3.13 (Samples) (with respect to the return or destruction of Samples), 9.4 (License Grant by Amgen) (with respect to the transition period referenced in Section 14.10 (Transition)), 9.5





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(License  Grant  by  GSK),  9.8  (Enforcement)  (with  respect  to  enforcement against activities that took place prior to expiration or termination), 9.9 (Patent Term Extensions) (with respect to periods prior to expiration or termination), 9.11.3 (Licenses) (with respect to the transition period referenced in Section 14.10  (Transition) and the sell-off period referenced therein), 10.3 (Product Technical  Complaints;  Recalls;  Returns),  11.1  (Confidentiality;  Exceptions), 11.2 (Authorized Disclosure), 11.3 (Confidential Treatment of Terms and Conditions), 11.7 (Attorney-Client Privilege), 11.8 (Injunctive Relief), 11.9 (Additional Permitted Disclosure), 14.8 (Effects of Expiration or Termination), and 14.10 (Transition), 14.11 (Tail Payments) will survive expiration or termination of this Agreement for any reason.  Following any such expiration or termination, medical inquiries with respect to Ivory will be referred by GSK to Amgen  in  accordance  with  instructions  provided  by  Amgen.    Except  as otherwise provided in this Section 14.7 (Effects of Expiration or Termination), all rights and obligations of the Parties under this Agreement will terminate upon expiration or termination of this Agreement for any reason.


		
	14.10.
	Transition.      During   all   applicable   notice   periods   prior   to   termination   under Sections 14.1 (Termination for Breach), 14.3 (Termination for Insolvency), 14.4 (Early Termination by Amgen), 14.7 (Failure to Supply) and 16.9 (Force Majeure) (provided; that with respect to transition following termination pursuant to Section 16.9 (Force Majeure), the Party subject to such Force Majeure or Judicial Force Majeure will not be liable for activities to the extent prevented from performing such activities due to the Force Majeure or Judicial Force Majeure giving rise to such termination.   GSK will continue to meet its obligations to promote Ivory within the Collaboration Scope, in accordance with the applicable Country Plan and this Agreement, unless otherwise requested by Amgen or agreed by the Parties.   Except for termination pursuant to Section  14.4  (Early  Termination  by  Amgen),  during  such  period  as  the  Parties determine is reasonably necessary (up to six (6) months) following the effective date of such termination, GSK will undertake reasonable efforts to effect a smooth and orderly transition of all commercial activities and responsibilities of GSK under this Agreement to Amgen, as soon as reasonably possible, to enable Amgen to continue the promotion and commercialization of Ivory in the Collaboration Scope after termination. Notwithstanding the foregoing, the Parties will use reasonable efforts to effect the transition as quickly as possible within the time periods referenced above.   For the avoidance of doubt, in the case of termination in accordance with Section 14.6 (Valid Safety Issue) GSK will have no obligation to Detail or commercialize Ivory, or take any other action that it reasonably believes presents a safety risk to patients (and GSK’s decision to not take such action will not be subject to Amgen’s final decision-making authority  under  Article  2  (Scope  and  Governance),  but  will  carry  out  its  other obligations pursuant to Section 14.8 (Effects of Expiration or Termination).   During any transition period subsequent to the expiration or termination of this Agreement, Amgen will reimburse GSK’s reasonable costs incurred at Amgen’s request in connection with the transition of responsibilities for Ivory in the Collaboration Scope to Amgen.




		
	14.11.
	Tail Payments.  Upon expiration of the Term pursuant to Section 14.1 (Term) Amgen will make a tail payment to GSK in each of the two (2) years of the Tail Period (i.e.,



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2023 and 2024) (each, a “Tail Payment”).  Such Tail Payments will be calculated as follows:


		
	14.11.1.
	No later than March 1, 2024, Amgen will pay GSK a Tail Payment in an amount equal to forty percent (40%) of Ivory Net Revenues for 2023 multiplied by the GSK 2022 Profit Share.




		
	14.11.2.
	No later than March 1, 2025, Amgen will pay GSK a Tail Payment in an amount equal to thirty percent (30%) of Ivory Net Revenues for 2024 multiplied by the GSK 2022 Profit Share.




		
	14.11.3.
	“GSK 2022 Profit Share” means fifty percent (50%) of that percentage that is determined by dividing an amount equal to (Ivory Net Revenues, less the Inventorship Margin, GSK Costs and Amgen Costs) by (Ivory Net Revenues for


		
	2022).
	If the GSK 2022 Profit Share equals zero (0) or a negative number, then GSK will not be entitled any Tail Payments pursuant to this Section 14.11 (Tail Payment).




		
	14.11.4.
	An example of the calculation of the payment to be made pursuant to this Section 14.11 (Tail Payment) is set forth on the Tail Payment Schedule. The provisions of Article 7 will apply to the Tail Payments.




		
	14.12.
	No  Limitation  of  Rights.     The  rights  provided  in  this  Article  14  (Term  and Termination) will be in addition and without prejudice to any other rights which the Parties may have with respect to any default or breach of the provisions of this Agreement.  Termination is not the sole remedy under this Agreement and, whether or not termination is effected, all other remedies at equity or law will remain available to the Parties except as expressly agreed otherwise herein.




		
	15.
	CHANGE OF CONTROL




		
	15.1.
	Change of Control of GSK.  GSK will give Amgen written notice within five (5) days after  the  public  announcement  or  disclosure  of,  or  if  earlier  the  signing  of  any agreement for, a proposed Change of Control of GSK.  In the event of the occurrence of, signing of an agreement for, or public announcement or disclosure of, any proposed Change of Control of GSK, Amgen will have the right to terminate this Agreement in its entirety (subject to Section 14.8 (Effects of Expiration or Termination) by buying out GSK’s remaining interest (including the value of any Tail Payments) in this Agreement at fair-market value.  If Amgen exercises such right, it will provide written notice to GSK (a “Change of Control Buyout Notice”) of such termination within sixty (60) days following the Change of Control.  Such termination will be effective ninety (90) days thereafter.  In the event of any such termination, Amgen will pay GSK the fair market value of GSK’s remaining interest so terminated (i.e., a one-time payment of the risk-adjusted net present value of the net profits GSK would expect to receive hereunder over the remainder of the Term (including, for the avoidance of doubt, the Tail Period) in the event the Agreement had not been so terminated (a “Change of Control Buyout Payment”) (but not less than zero)).  Within twenty (20) days following Amgen’s provision of the Change of Control Buyout Notice, the Parties will meet and negotiate the amount of such Change of Control Buyout Payment.  If the Parties agree on the amount of the Change of Control Buyout Payment within such twenty (20) day



70










period, then Amgen will pay GSK the Change of Control Buyout Payment within thirty (30) days following the effective date of such termination.  If the Parties fail to agree on an amount of a Change of Control Buyout Payment within twenty (20) days following the provision of the Change of Control Buyout Notice, then GSK will propose to Amgen in writing four (4) Third Party valuators (two (2) top-tier, internationally- recognized   investment   banks   and   two   (2)   top-tier,   internationally   recognized accounting firms) with relevant expertise to determine the appropriate amount for the Change of Control Buyout Payment.   Within ten (10) days of the receipt of such proposal, Amgen will select one (1) of the proposed valuators by written notice to GSK.    The  Parties  will  share  equally  the  costs  incurred  in  connection  with  the valuator’s services.  Each of the Parties will provide to such valuator such information as it deems pertinent and any information requested by such valuator.  Such selected valuator will promptly (and in any event within forty-five (45) days after the selection of  such  valuator)  determine  the  Change  of  Control  Buyout  Payment  amount  and provide notice of the Change of Control Buyout Payment amount (and underlying assumptions and methodology) to each of the Parties.   Amgen will have fifteen (15) days from receipt of notice of the Change of Control Buyout Payment amount from the valuator to provide written notice to GSK of whether or not the Change of Control Buyout Notice previously provided pursuant to this Section 15.1 (Change of Control) will remain effective at the Change of Control Buyout Payment amount specified by the valuator.   Should Amgen specify that such notice will remain effective, then the Change of Control Buyout Notice will be effective as of the date specified in the original Change of Control Buyout Notice and Amgen will pay GSK the Change of Control Buyout Payment within thirty (30) days following the effective date of such termination.  Should Amgen specify that the Change of Control Buyout Notice will not remain effective, then such Change of Control Buyout Notice will be void and this Agreement will continue unimpaired and in full force and effect.


		
	15.2.
	Change of Control of Amgen.   Amgen will give GSK written notice within five (5) days after the public announcement or disclosure of, or if earlier the signing of any agreement for, a proposed Change of Control of Amgen (a “Change of Control Notice”).  In the event of the occurrence of a Change of Control of Amgen, if the entity acquiring ownership of Amgen is in the top five (5) pharmaceutical companies in the European Union by sales in the full calendar year immediately prior to the year in which such Change of Control occurs then GSK will have the right to terminate this Agreement in its sole discretion upon written notice to be delivered to Amgen within sixty (60) days receipt of such Change of Control Notice.   In the event of any such termination, GSK will reasonably cooperate with Amgen for a period of up to one year from the date of termination (as requested by Amgen (or its successor)) to effectuate a smooth transition of the activities being conducted by GSK to Amgen.   During such one (1) year period, GSK will continue to perform in accordance with the applicable Country Plans, Brand Plan and Development Plan in effect as of the date of the Change of Control Notice (except as reasonably necessary to effectuate the transition), and the activities of the committees and teams hereunder will be limited to those reasonably necessary to effectuate such smooth transition.  If GSK does not exercise its right to terminate the Agreement due to a Change of Control of Amgen as described herein, then the Agreement will continue unimpaired and in full force and effect.



71










		
	16.
	MISCELLANEOUS




		
	16.1.
	Affiliates.    Each  Party  will  have  the  right  to  exercise  its  rights  and  perform  its obligations hereunder through its Affiliates (including by licensing rights hereunder where such rights are held in the name of any such Affiliate); provided that such Party will be responsible for its Affiliates’ performance hereunder.




		
	16.2.
	Arbitration.  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, neither Party will have the right to terminate this Agreement until resolution of the dispute pursuant to this Section 16.2 (Arbitration), 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 Agreement that the arbitrator determines to be required to be performed by a Party must be completed within a reasonable time period following the final decision of the arbitrator.   The 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 arbitrator’s fees and any administrative fees of arbitration.




		
	16.3.
	Assignment.  Neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred (whether by operation of Applicable Law, general succession or otherwise) by either Party without the prior written consent of the other Party; provided that either Party may assign this Agreement, or rights and obligations hereunder, without prior written consent to any Affiliate, and Amgen may assign this Agreement without prior written consent in connection with the transfer or sale of all or substantially all of the business of Amgen to which this Agreement relates.   Any assignment not in accordance with this Agreement will be void.   Subject to the foregoing,  the  rights  and  obligations  of  the  Parties  under  this  Agreement  will  be binding upon and inure to the benefit of the successors and permitted assigns of the Parties.




		
	16.4.
	Choice of Law.  This Agreement will be governed by, and enforced and construed in accordance with, the laws of the State of New York 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.



72










		
	16.5.
	Compliance with Applicable Law.  No Party will be required by this Agreement to take or omit to take any action in contravention of Applicable Law or applicable national and international pharmaceutical industry codes of practices.




		
	16.6.
	Construction.  The definitions of the terms herein will apply equally to the singular and plural forms of the terms defined.  Whenever the context may require, any pronoun will include the corresponding masculine, feminine and neuter forms.  The words “include”, “includes” and “including” will be deemed to be followed by the phrase “without limitation”.   The Parties each acknowledge that they have had the advice of counsel with respect to this Agreement, that this Agreement has been jointly drafted, and that no rule of strict construction will be applied in the interpretation hereof.   Unless the context requires otherwise: (i) a reference to a Party’s costs includes both internal FTE costs  at  the  FTE  Rate  and  reasonable  Third  Party  costs;  (ii)  any  definition  of  or reference to any agreement, instrument or other document herein will be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein); (iii) any reference  to  any  Applicable  Law  herein  will  be  construed  as  referring  to  such Applicable Law as from time to time enacted, repealed or amended; (iv) any reference herein to any person will be construed to include the person’s permitted successors and assigns; (v) the words “herein”, “hereof” and “hereunder”, and words of similar import, will be construed to refer to this Agreement in its entirety and not to any particular provision hereof; and (vi) all references herein to Articles, Sections, Schedules or Exhibits, unless otherwise specifically provided, will be construed to refer to Articles, Sections, Schedules or Exhibits of this Agreement.  This Agreement has been executed in English, and the English version of this Agreement will control.




		
	16.7.
	Counterparts.  This Agreement may be executed in counterparts with the same effect as if both Parties had signed the same document.  All such counterparts will be deemed an original, will be construed together and will constitute one and the same instrument. Signature pages of this Agreement may be exchanged by facsimile or other electronic means without affecting the validity thereof.




		
	16.8.
	Currency.  With respect to amounts required to be converted into another currency for calculation or payment, hereunder, such amounts will be converted using a rate of exchange which corresponds to the rate used for conversion between the relative currencies by whichever Party recorded the relevant receipt or expenditure, for the respective reporting period in its books and records that are maintained in accordance with GAAP or IFRS, as the case may be.  If a Party is not required to perform such a currency conversion for its GAAP or IFRS reporting with respect to the applicable period, then for such period such Party will make such conversion using the rate of exchange which corresponds to the noon buying rate as published in the Wall Street Journal, Eastern U.S. Edition on the second to last business day of the calendar quarter (or such other publication as agreed-upon by the Parties) in which such receipt or expenditure was incurred.




		
	16.9.
	Entire Agreement.  This Agreement, including the attached Appendices, Schedules and Exhibits constitutes the entire agreement between the Parties as to the subject matter of this Agreement, and supersedes and merges all prior or contemporaneous negotiations,



73










representations, agreements and understandings regarding the same.   Nothing in this Agreement s intended to modify, abrogate or eliminate those rights and obligations of the Parties expressly set forth in the Expansion Agreement.


		
	16.10.
	Force Majeure.  Neither 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 causes beyond its reasonable control, including acts of God, fires, floods, earthquakes, labor strikes, acts of war, terrorism or civil unrest (“Force Majeure”); provided, that the affected Party promptly notifies the other Party in writing (and continues to provide monthly status updates to the other Party 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.  If the performance of any obligation or activity of either Party that is fundamental to the commercial success of Ivory in the Collaboration Scope is prevented by such Force Majeure event for a period of more than one (1) year, then either Party may terminate this Agreement upon thirty (30) days written notice, unless such obligation is performed within such thirty (30) day notice period.   In addition, neither Party will be liable for delay or failure in the performance of any material obligations assigned to it pursuant to Section 3.3 (Designated GSK Activities) or 3.4 (Designated Amgen Activities) to the extent such delay or failure is due to a judicial injunction issuing within three (3) years of the Effective Date and prohibiting such  performance  (a  “Judicial  Force  Majeure”);  provided,  that,  unless  otherwise agreed by the Parties, the affected Party: (i) promptly notifies the other Party in writing (and continues to provide monthly status updates to the other Party for the duration of the effect); (ii) uses reasonable efforts prior to and during litigation to mitigate the effect of or appeal such injunction (but in no event will such Party have any obligation to  take  any  actions  to  the  extent  deemed  unadvisable  by  such  Party’s  litigation counsel); (iii) cooperates with the JSC to create contingency plans in advance of any threatened injunction; (iv) cooperates with the JSC to determine a plan to provide substitute or remedial performance to the extent substitute or remedial performance is reasonably possible (which plan may provide for either or both Parties to undertake some or all of such substitute or remedial performance); and (v) performs in accordance with any contingency or substitute or remedial performance plans adopted by the JSC. The costs of such substitute or remedial performance will be included GSK Costs and/or Amgen Costs as the case may be.  In the event of a Judicial Force Majeure that, by its terms, would prevent the performance by a Party of any obligation assigned to it pursuant to Section 3.3 (Designated GSK Activities) or 3.4 (Designated Amgen Activities) the performance of which is fundamental to the commercial success of Ivory in the Collaboration Scope for a period of more than six (6) consecutive months, and no reasonable substitute or remedial performance can be provided by either Party on its own or the Parties working together, then: (a) the Parties will promptly (and, in any event, within ten (10) business days of the request of the other Party) meet to discuss the situation; and (b) if the Parties are unable to reach a mutually acceptable solution within fifteen (15) days after initiation of such discussions (and the Judicial Force Majeure has not been eliminated by such time), then either Party will have the right to terminate this Agreement by written notice to the other, given within fifteen (15) days



74










of the end of such fifteen (15) day discussion period.  In the event of a Judicial Force Majeure that, by its terms, would prevent the performance by a Party of any material obligation pursuant to this Agreement in either: (x) any of France, Germany, Italy, Spain or the United Kingdom; or (y) five (5) or more countries in the Collaboration Territory, in each case for a period of more than thirty (30) consecutive days, and no reasonable substitute or remedial performance can be provided by the Party subject to the relevant injunction, then: (a) the Parties will promptly (and, in any event, within fifteen (15) days of the request of the other Party) meet to discuss the situation; and (b) if the Parties are unable to reach a mutually acceptable solution within thirty (30) days after initiation of such discussions (and the Judicial Force Majeure has not been eliminated by such time), then the Party not subject to the Judicial Force Majeure will have the right to terminate this Agreement with respect to the country or countries in which such performance is so prevented by thirty (30) days prior written notice to the other, given within fifteen (15) days of the end of such thirty (30) day discussion period (and, in addition, in the event such performance is so prevented in two (2) or more of France, Germany, Italy, Spain or the United Kingdom or ten (10) or more countries in the Collaboration Territory in total, then the Party not subject to the Judicial Force Majeure will have the right to terminate this Agreement with respect to the country or countries in which such performance is so prevented by thirty (30) days prior written notice to the other, given within fifteen (15) days of the end of such thirty (30) day discussion period).   For the avoidance of doubt, if reasonable substitute or remedial performance can be provided by either Party on its own or the Parties working together, then the Parties will cooperate as provided above in the implementation of such substitute or remedial performance as set forth in the plan established by the JSC.  For the purposes of this Section 16.10 (Force Majeure): (1) “fundamental to the commercial success of Ivory” will mean likely to have a material adverse effect on Ivory Net Revenues in at least three (3) of the United Kingdom, Germany, Italy, Spain and France ; and (2) the provision of reasonable substitute or remedial performance will include provision of such performance through a third party contractor, or the retention of additional personnel to provide such performance.


		
	16.11.
	Further Assurances.   Each Party agrees to do and perform all such further acts and things and will execute and deliver such other agreements, certificates, instruments and documents necessary or that the other Party may reasonably request in order to carry out the intent and accomplish the purposes of this Agreement and to evidence, perfect or otherwise confirm its rights hereunder.




		
	16.12.
	Headings.  Headings and captions are for convenience only and are not to be used in the interpretation of this Agreement.




		
	16.13.
	No Set-Off.   Except as expressly set forth in Section 6.1.9 (True-Up), Section 7.6 (Withholding) or Section 7.7 (VAT), no Party will have the right to deduct from amounts otherwise payable hereunder any amounts payable to such Party (or its Affiliates) from the other Party (or its Affiliates), whether pursuant to this Agreement or otherwise.




		
	16.14.
	Notices.   Any notice required or permitted to be given by this Agreement will be in writing, in English, and will be delivered by hand or overnight courier with tracking





75










capabilities or mailed postage prepaid by registered or certified mail addressed as set forth below unless changed by notice so given:


	
		
	If to Amgen:
	Amgen Inc.

	 
	One Amgen Center Drive

	 
	Thousand Oaks, California 91320-1799

	 
	Attention: Corporate Secretary

	 
	Telephone: 805-447-1000

	 
	Facsimile: 805-499-6751

	 
	 

	If to GSK:
	GlaxoSmithKline

	 
	709 Swedeland Road

	 
	P.O. Box 1539

	 
	King of Prussia, PA 19406-0939

	 
	USA

	 
	Attention: Senior Vice President, Worldwide Business Development

	 
	Telephone: +1-610-270-5397

	 
	Facsimile:  +1-610-270-5880

	 
	 

	 
	With a copy to:

	 
	 

	 
	GlaxoSmithKline

	 
	2301 Renaissance Boulevard

	 
	Mailcode RN0220

	 
	King of Prussia, PA 19406-2772

	 
	USA

	 
	Attention: Vice President and Associate General Counsel, Business

	 
	Development Transactions

	 
	Telephone: +1-610-787-4093

	 
	Facsimile:  +1-610-787-7084






Any such notice will be deemed given on the date delivered.  A Party may add, delete (so long as at least one person is remaining), or change the person or address to which notices should be sent at any time upon written notice delivered to the other Party in accordance with this Section 16.14 (Notices).


		
	16.15.
	Relationship of the Parties.  Each Party is an independent contractor under this Agreement.   Nothing  contained  herein  will  be  deemed  to  create  an  employment, agency, joint venture or partnership relationship between the Parties or any of their agents or employees, or any other legal arrangement that would impose liability upon one Party for the act or failure to act of the other Party.  The Parties will operate their own businesses separately and independently and they will hold themselves out as, act as, and constitute independent contractors in all respects and not as principal and agent, partners or joint venturers.  The Parties will each be responsible for fulfilling their own obligations under this Agreement, and they will not have control or responsibility over the actions of the other Party.  The Parties will make and receive only such payments as are required under this Agreement for sales and services required hereunder, and will



76










not share in, or participate in, the business operations of the other Party.  Neither party will have any express or implied power to enter into any contracts or commitments or to incur any liabilities in the name of, or on behalf of, the other Party, or to bind the other Party in any respect whatsoever.  Each Party will file all necessary reports, statements, tax returns, information returns and any other filings with the FDA, the Securities and Exchange Commission, U.S. Internal Revenue Service, any regulatory authority or any other Governmental Authority on the basis that is consistent with the terms of this Section.


		
	16.16.
	Severability.  To the fullest extent permitted by Applicable Law, the Parties waive any provision  of  Applicable  Law  that  would  render  any  provision  in  this  Agreement invalid, illegal or unenforceable in any respect.  If any provision of this Agreement is held to be invalid, illegal or unenforceable, in any respect or to any extent, then in such respect and to such extent such provision will be given no effect by the Parties and shall not form part of this Agreement.  To the fullest extent permitted by Applicable Law, all other provisions of this Agreement shall remain in full force and effect and the Parties will use their commercially reasonable efforts to negotiate a provision in replacement of the provision held invalid, illegal or unenforceable that is consistent with Applicable Law and achieves, as nearly as possible, the original intention of the Parties.




		
	16.17.
	Standstill.   GSK agrees that, for a period commencing on the Effective Date and expiring on the fifth (5th) anniversary thereof, except pursuant to the terms of a specific written invitation in writing by the Chief Executive Officer of Amgen, or except as otherwise approved by Amgen’s Board of Directors, neither GSK nor any of its Affiliates will in any manner, directly or indirectly: (a) effect or seek, offer or propose (whether publicly or otherwise) to effect, or announce any intention to effect or propose (whether publicly or otherwise) to effect, or cause or participate in, or in any way assist, facilitate or encourage any other Person to effect or seek, offer or propose (whether publicly or otherwise) to effect, or cause or participate in: (i) any acquisition of Voting Securities (or beneficial ownership thereof) of Amgen or its Affiliates, or rights or options to acquire any Voting Securities (or beneficial ownership thereof) of Amgen or its Affiliates, or any assets, indebtedness or businesses of Amgen or its Affiliates; (ii) any  tender  or  exchange  offer,  merger  or  other  business  combination  involving Amgen,  any  of  its  Affiliates  or  assets  of  Amgen  or  its  Affiliates  constituting  a significant portion of the consolidated assets of Amgen and its Affiliates; (iii) any recapitalization, restructuring, liquidation, dissolution or other extraordinary transaction with respect to Amgen or any of its Affiliates; or (iv) any “solicitation” of “proxies” (as such terms are used in the proxy rules of the Securities and Exchange Commission) or consents to vote any Voting Securities of Amgen or any of its Affiliates;  (b) form, join or in any way participate in a “group” (as defined under the Exchange Act), with respect to Amgen or otherwise act in concert with any person in respect of any Voting Securities of Amgen or any of its Affiliates; (c) otherwise act, alone or in concert with others (including by providing financing for another person), to seek representation on or to control or influence the management, Board of Directors or policies of Amgen or to obtain representation on the Board of Directors of Amgen; (d) take any action which would  reasonably  be  expected  to  force  Amgen  to  make  a  public  announcement regarding any of the types of matters set forth in (a) above; or (e) enter into any discussions or arrangements with any Third Party with respect to any of the foregoing.





77










		
	16.17.1.
	GSK and its Affiliates hereby acknowledge that they do not beneficially own any Voting Securities of Amgen or have other rights or options to acquire such Voting Securities (or beneficial ownership thereof).  Notwithstanding any of the foregoing restrictions, nothing will prohibit GSK and its Affiliates from: (i) individually and collectively purchasing, beneficially owning or selling any Voting Securities that represent in the aggregate less than five percent (5%) of the outstanding Voting Securities of Amgen; and/or (ii) entering into and participating in any other existing and future commercial relationships and arrangements between Amgen and/or its Affiliates and GSK and/or its Affiliates in the ordinary course of business (i.e., collaboration, licensing, research, development, marketing and other comparable relationships).




		
	16.17.2.
	GSK will be relieved of the foregoing standstill obligations in the event: (i) Amgen publicly announces that is has entered into a definitive agreement relating to a Change of Control of Amgen; (ii) Amgen publicly announces a formal decision of Amgen’s Board of Directors (or a committee thereof) to conduct a process to sell all or substantially all of the assets of Amgen and its Affiliates on a consolidated basis; provided, that the standstill obligations will be automatically reinstated if Amgen publicly announces a termination of such process; (iii) a Third Party commences a tender offer for more than fifty percent (50%)   of   the   Voting   Securities   of   Amgen   and   Amgen   has   publicly recommended acceptance of such tender offer; provided, that the standstill obligations will be automatically reinstated in the event such tender offer is terminated; and (iv) upon the completion of a Change of Control of Amgen.




		
	16.17.3.
	The provisions of this Section 16.17 (Standstill) will not be construed or interpreted to prohibit GSK in any manner from making any bid or offer to license or acquire rights to any asset(s) of Amgen (other than substantially all of the assets of Amgen and its Affiliates) as opposed to acquiring securities of Amgen if such bid or offer is solicited from GSK by Amgen.  The foregoing standstill obligations will not prohibit GSK from confidentially communicating to Amgen’s Chief Executive Officer or Chairman of the Board of Directors a non-public indication of GSK’s interest in pursuing a potential transaction involving Amgen in such a manner that would not require Amgen to make public disclosure.  Neither the ownership nor purchase by an employee benefit plan of GSK or GSK’s Affiliates in any diversified index, mutual or pension fund managed by an independent advisor, which fund in turn holds, directly or indirectly,  securities  of  Amgen  will  be  deemed  to  be  a  breach  of  GSK’s standstill obligations under this Section 16.17 (Standstill).  If GSK, or GSK’s Affiliates, acquires securities of, or other ownership interest in, a Third Party that directly or indirectly owns any securities or property of Amgen, such acquisition will not be deemed to be a breach of GSK’s standstill obligations under this Section 16.17 (Standstill), subject to GSK’s compliance with all other terms of this Agreement and provided that, if GSK and its Affiliates then beneficially own in the aggregate five percent (5%) or more of the outstanding Voting  Securities  of  Amgen,  GSK  will  notify  Amgen  thereof  promptly following such acquisition and will dispose of Voting Securities of Amgen, in sufficient number so that GSK and its Affiliates no longer beneficially own



78










Voting Securities of Amgen that represent in the aggregate five percent (5%) or more of the outstanding Voting Securities of Amgen, in orderly market transactions within one hundred twenty (120) days after such acquisition.


		
	16.18.
	Third Party Beneficiaries.   Except as expressly provided with respect to Amgen Indemnitees or GSK Indemnities in Article 13 (Indemnification), there are no Third Party beneficiaries intended hereunder and no Third Party will have any right or obligation hereunder.




		
	16.19.
	Waivers and Modifications.  The failure of any Party to insist on the performance of any obligation hereunder will not be deemed to be a waiver of such obligation.  Waiver of any breach of any provision hereof will not be deemed to be a waiver of any other breach of such provision or any other provision on such occasion or any other occasion. No waiver, modification, release or amendment of any right or obligation under or provision of this Agreement will be valid or effective unless in writing and signed by all Parties hereto.




*********


(Signature page follows)





79








IN WITNESS WHEREOF, the Parties have executed this Collaboration Agreement as of the Effective Date.


	
			
	GLAXO GROUP LIMITED
	 
	AMGEN INC.

	 
	 
	 

	 
	 
	 

	By: /s/ Paul Williamson
	 
	By: /s/ Robert A. Bradway

	 
	 
	 

	Name: Paul Williamson
	 
	Name: Robert A. Bradway

	 
	 
	 

	Title: Edinburgh Pharmaceutical Industries Limited
	 
	Title: Executive Vice President &

	Corporate Director
	 
	Chief Financial Officer

























Collaboration Territory Schedule




Andorra 
Australia 
Austria 
Belgium 
Bulgaria Cyprus
Czech Republic 
Denmark Estonia
Finland
France (including French Overseas Departments and Territories (French: départements d’outre-mer and territoires d’outre-mer or DOM-TOM))
Germany 
Greece 
Hungary 
Iceland 
Ireland 
Italy 
Latvia
Liechtenstein 
Lithuania 
Luxembourg 
Malta
Mexico 
Monaco 
Netherlands 
New Zealand 
Norway 
Poland 
Portugal 
Romania
Russian Federation 
San Marino 
Slovakia
Slovenia 
Spain 
Sweden 
Switzerland
United Kingdom
Vatican City













Development Budget Schedule


	
					
	 
	2H 2009
	2010
	2011
	2012

	Allocated Outside
	 
	 
	 
	 

	Expense, ($m)
	9.0 
	29.2 
	34.0
	28.3

	 
	 
	 
	 
	 

	Allocated R&D 
Employee
Expenses, ($m) 
	6.2
	17.1
	16.3
	14.9

	 
	 
	 
	 
	 

	Other Allocated
Costs, ($m)              
	—
	0.5
	0.6
	0.4

	 
	 
	 
	 
	 

	TOTAL ($m)
	15.2
	46.8
	50.9
	43.6






Costs are allocated to the collaboration as accrued.













FTE Rate Schedule


	
									
	 
	Australia/
New Zealand
	Austria
	Belux
	CEE
	France/
Monaco
	Germany
	Greece/
Cyprus
	Switzerland

	Shared Sales Management
	280,000
	280,000
	280,000
	280,000
	345,000
	340,000
	280,000
	280,000

	Primary Care Sales Force
	140,000
	140,000
	150,000
	130,000
	140,000
	150,000
	140,000
	140,000

	Specialty Care Sales Force
	150,000
	180,000
	210,000
	180,000
	170,000
	230,000
	130,000
	180,000

	Marketing
	210,000
	290,000
	350,000
	160,000
	260,000
	320,000
	310,000
	300,000

	Sales and Mktg Effect.
	140,000
	200,000
	210,000
	200,000
	200,000
	210,000
	200,000
	230,000

	Corporate Affairs / Access
	260,000
	275,000
	275,000
	250,000
	200,000
	250,000
	230,000
	250,000

	Medical
	160,000
	260,000
	230,000
	180,000
	230,000
	240,000
	200,000
	260,000

	G&A/Other
	160,000
	230,000
	230,000
	200,000
	180,000
	190,000
	210,000
	200,000

	Other R&D
	250,000
	250,000
	250,000
	250,000
	250,000
	250,000
	250,000
	250,000




CEE: Bulgaria, Czech Republic, Hungary, Poland, Romania, Russia, Slovakia, Slovenia









	
								
	 
	Italy (Malta,
San Marino,
Vatican City)
	Mexico
	Netherlands
	Nordics
	Portugal
	Spain/Andora
	UK/Ireland

	Shared Sales Management
	280,000
	280,000
	280,000
	280,000
	280,000
	280,000
	280,000

	Primary Care Sales Force
	140,000
	140,000
	140,000
	160,000
	140,000
	140,000
	140,000

	Specialty Care Sales Force
	170,000
	190,000
	190,000
	200,000
	180,000
	180,000
	200,000

	Marketing
	300,000
	300,000
	280,000
	210,000
	250,000
	290,000
	250,000

	Sales and Mktg Effect.
	190,000
	220,000
	240,000
	230,000
	180,000
	170,000
	180,000

	Corporate Affairs / Access
	180,000
	200,000
	250,000
	275,000
	200,000
	260,000
	170,000

	Medical
	170,000
	240,000
	220,000
	200,000
	180,000
	180,000
	220,000

	G&A/Other
	160,000
	220,000
	230,000
	200,000
	200,000
	180,000
	210,000

	Other R&D
	250,000
	250,000
	250,000
	250,000
	250,000
	250,000
	250,000




Nordics: Denmark, Finland, Iceland, Norway, Sweden, Estonia, Latvia and Lithuania


For any categories of FTE not included above, a $250,000 rate will be used for personnel located in the countries set forth in the tables above.
For any personnel not located in a country set forth in the tables above (including the United States), a $275,000 rate will be used.















Schedule
Diligence Materials


	
			
	CATEGORY
DEVELOPMENT
	DOCUMENT DESCRIPTION
	FILE NAME

	OSTEOPOROSIS
	 
	 

	 
	Osteo Global File - module 2
	summary-clin-safety.pdf

	 
	Osteo Global File - module 2
	summary-clin-pharm.pdf

	 
	Osteo Global File - module 2
	summary-clin-efficacy-pmo.pdf

	 
	Osteo Global File - module 2
	summary-clin-efficacy-halt.pdf

	 
	Osteo Global File - module 2
	summary-biopharm.pdf

	 
	Osteo Global File - module 2
	nonclinical-overview.pdf

	 
	Osteo Global File - module 2
	clinical-overview.pdf

	REGULATORY
	 
	 

	US
	 
	 

	 
	Background Document for Meeting of Advisory Committee for
Reproductive Health Drugs (August 13, 2009)
	

AC Bkgd Doc_denosumab_clearedfinal.pdf

	EU
	 
	 

	 
	Nov. 27th Co-Rapporteur meeting minutes - Germany
	08_1912_minutes_corapp meeting_27nov08.pdf

	 
	Dec. 8th Co-Rapporteur meeting minutes - Sweden
	DmAb Rapp Meeting MPA 8 Dec 08 Final.pdf

	 
	Rapporteurs Presubmission Meeting Briefing Document - Oct 08
	08_1610_briefing doc_pmo-halt_rapp meeting.pdf

	AUS
	 
	 

	 
	M1 Australia regional docs
	16 pdf documents

	SWISS
	 
	 

	 
	Swiss M1
	17 pdf documents

	 
	Swiss M1 Cover Letter Translation
	09_1102_cl_maa_ch.pdf

	PRE-CLINICAL STUDIES
	 
	 

	 
	Report 2004321
	R2004321_Final_Formatted.pdf

	 
	Report 2004430
	R2004430_Final_Formatted.pdf

	 
	Report 2005410
	R2005410 Roudier et al., 2006.pdf

	 
	Report 2005412
	R2005412 gonzalez suarez 2007.pdf

	 
	Report 2005600
	R2005600_FinalPDF_07Feb2007.pdf

	 
	Report 2006160
	R2006160_FinalPDF_15Aug2006.pdf

	 
	Report 2006161
	R2006161_FinalPDF_16Aug2006.pdf

	 
	Report 2006351
	R2006351_Final_Formatted.pdf













	
			
	 
	Report 2006460
	R2006460_FinalPDF_20Dec2006.pdf

	 
	Report 2006533
	R2006533_FinalPDF_04Dec2007.pdf

	 
	Report 20080083
	R20080083 FPA_Miller PC3 Manuscript.doc

	 
	Report 20080083
	R20080083 Miller PC3 manuscript Figures

	 
	 
	7Dec07.pdf

	 
	Tox_ ADME Module 4 Study Reports
	01 GUIDE Listing of Nonclinical Studies

	 
	 
	03032008.pdf

	 
	Tox_ ADME Module 4 Study Reports
	101002_101003_2001-

	 
	 
	1108_IAPHARMTOX_SUBMISSION TEXT.pdf

	 
	Tox_ ADME Module 4 Study Reports
	R2004321_Final.pdf 

	 
	Tox_ ADME Module 4 Study Reports
	R2004430_Final.pdf

	 
	Tox_ ADME Module 4 Study Reports
	R2006351_Final.pdf






	
			
	CLINICAL STUDIES
5353 Rep Anal
	 
	 

	 
	Immuno Overview
	immuno-overview.pdf

	 
	Integrated Analysis of Safety
	iss.pdf

	CANCER
	 
	 

	 
	20040113- Ph2 Oncology
	CSR

	 
	20040114 - Ph 2 Breast Cancer
	CSR

	 
	20040215 - Ph 2 Giant Cell
	protocol

	 
	20050103 - Ph 3 Prostate
	protocol

	 
	20050134 - Ph 2 MM
	CSR

	 
	20050136 - Ph 3 Breast Cancer
	protocol

	 
	20050147 - Mets Prevention
	protocol

	 
	20050244 - Ph 3 Solid Tumor
	protocol

	 
	20060359
	20060359 Study Protocol Synopsis.pdf

	HALT
	 
	 

	 
	20040135
	CSR

	 
	20040138
	CSR

	 
	20050209 - Ph3 ABCSG Breast Ca TIBL
	protocol

	Individual Studies
	 
	 

	 
	20050146 - Vial vs PFS Bioequivalene
	CSR

	 
	20050227 - ATO vs ACO Bioequivalence
	CSR













	
			
	 
	20060286
	CSR

	 
	20060446
	CSR

	 
	20080178 protocol 3/19/09
	20080178 GIOP PROTOCOL 19MAR2009.pdf

	 
	098 Male Osteo protocol
	Male osteo 098 protocol PRC sub.pdf

	PK Initial
tolerability
	 
	 

	 
	20010123  Ph1 Oncology
	CSR

	 
	20010124  Ph1 Oncology
	CSR

	 
	20050241 Ph1 Metabolic disorders
	CSR

	 
	20030148
	CSR

	 
	20030164
	CSR

	 
	20030180
	CSR

	PMO
	 
	 

	 
	20030216 - Ph 3 Fracture Study
	CSR

	 
	20040132-36m
	CSR 24-month, CSR 36-month

	 
	20050141 - Ph 3 Head-to-Head
	CSR

	 
	20050233
	CSR

	 
	20050234 - BP Transition
	CSR

	 
	20060232 Ph3 Metabolic disorders
	CSR

	 
	 
	02 Protocol - Amendments49 AMG
16220060232.pdf

	 
	20,060,237
	CSR

	 
	20060289 study Ph3 PMO
	protocol

	 
	20060289 (216 extension) protocol (amendment 3/9/
	02 Protocol - Amendments49 AMG
16220060289.pdf

	 
	20010223 - Ph 2 PMO
	CSR

	 
	20,050,179
	CSR

	 
	20050172 - Japan Phase 2 PMO
	CSR

	 
	20080099 protocol 3/18/09
	20080099 protocol 18 March post PRC.pdf

	Other
	 
	 

	 
	Listing of clinical studies
	tabular-listing.pdf

	 
	Dmab Osteo Lifecycle management studies
	Dmab LCM Study Plan.ppt

	 
	Synopsis of Post-Marketing Global Safety Assessment
	DPMGSA Study Synposis.pdf

	 
	 
	 

	 
	Study Proposal - 20090287
	Denosumab PM Safety study June 15 SCD Nordic















	
			
	 
	Study Proposal – 20090286
	Denosumab PV Feasibility study June 15 SCD

	 
	 
	Nordic (20090286).pdf

	 
	Study Concept Synopsis - Denosumab Global Safety
	 

	 
	Assessment Among Post Menopausal Osteoporosis (PMO)
	Dmab PV_Study Synopsis_final.pdf

	 
	Women Using Multiple Observational Databases
	 

	 
	Real World Effectiveness fracture study- Draft Study Design.
	RWE Draft Design.pdf

	 
	Study 20050136 Benefit:Risk Summary for Regulatory
	 

	 
	Submission
	Flash_Memo_20050136_July2009.pdf

	 
	 
	 

	IP
	Study 20050136 Benefit:Risk Summary for Regulatory
Submission
	Flash_Memo_20050136_July2009.pdf

	 
	List of IP
	Collaboration_IP_list.pdf
Expansion_IP_list.pdf
Pending_opposition.pdf

	 
	Letter from Cellectis
	CellectisRedactedDoc071709.pdf

	 
	Non-Exclusive Antibody Patent License Agreement (between
Amgen and Genentech dated January 25, 2006)
	Antibody License 1.pdf

	 
	Non-Exclusive Cabilly Patent License Agreement (between Amgen and Genentech dated January 25, 2006)
	Antibody License 2.pdf

	 
	Collaboration Agreement by and between Amgen, Inc and
Daiichi Sankyo Company, Ltd (dated July 11, 2007)
	Daiichi Sankyo Agreement.redacted.pdf

	 
	License Agreement (dated March 29, 1994) between MRC and
Cell Genesys
	MRC License.pdf

	Other
	 
	 

	 
	COS further build
	Dmab COS Range (5 18 09)vICO_v2.pdf

	 
	Deck from Commercial interaction Zug June 25th
	SAFARI_OPEX Comparison_June
25th_vDATAROOM.pdf

	 
	Sales, OPEX and FTEs for Italy, Greece, Netherlands and
Australia.
	Additional Country Sales & OPEX.pdf

	CMC
	 
	 

	 
	CMC Overview Presentation from Wen Ryan
	Safari 06-09-2009_FINAL.pdf

	 
	 
	drug-product_R.pdf

	 
	QOS (Quality Overall Summary) -redacted - from m2
	drug-substance_R.pdf
introduction_R.pdf regional-information.pdf

	 
	EMEA 80-day Assessment - Amgen summary deck
	RA CMC RTQ Status_May 09.pdf

	 
	Figures demonstrating binding data and epitope mapping
	Figures_2_4.pdf

	 
	Light Chain/Heavy Chain amino acid sequences
	LightChain_HeavyChain.pdf















	
			
	 
	EMEA 120-Day Assessment - redacted quality section
	Day 120 LoQ_highlighted_CMC_R.pdf

	GLOBAL SAFETY
	 
	 

	 
	The "DDPS" - a detailed description of Amgen's PV systems (DDPS).
	DD of PV System_v3.pdf

	COMMERCIAL
	 
	 

	 
	SmPC
	Final Submitted SmPC January 09.pdf

















	
			
	CATEGORY
Clinical Programs


	DOCUMENT DESCRIPTION
	FILE NAME

	 
	Investigator's Brochure
	IB Investigator Brochure,49 AMG 162.pdf

	 
	Overview of Clinical Safety
	 

	 
	Extracts from Summary of Pharmacovigilance Systems
	clinical-overview.pdf

	 
	document
	SPS.pdf

	 
	Preclinical data pack
	

Denosumab Preclinical Publications_6-11-09.xls

	 
	

IND Safety Reports May 08 - June 09
	585 pdf documents

	 
	Quarterly Safety Update Reports Aug 08 - April 09
	4 pdf documents

	 
	Integrated analysis of safety
	iss.pdf

	 
	Phase 4 Overview
	Ph 4 Study Overview.ppt

	 
	PKDM Validation Reports
	11 pdf files

	Regulatory
	 
	 

	 
	MAA sections m1, m2, m4, m5
	MAA sections m1, m2, m4, m5

	 
	

*NICE Horizon scan
*Proforma to NICE
*Official record of Amgen's key positions for NICE evaluation.
*NICE meeting minutes
	5 word docs













	
			
	 
	 
	EU:

	 
	European Agencies: Records of communications regarding MAA
	Pre-filing mtgs - 10 docs

	 
	validation, Rapporteurs Meeting, Scientific Advice, EMEA Pre
	MAA validation - 1 doc

	 
	filing meetings.
	Rapporteurs Mtg - 2 docs

	 
	 
	Scientific Advice - 8 docs

	 
	FDA: Meeting correspondence log from BLA m1.Also,
	 

	 
	discussion with FDA in Jan 09 to discuss advanced cancer pre-
	 

	 
	BLA submission.
	FDA: meeting-correspondence.pdf

	 
	 
	MTGSUM 9838 Pre-BLA 1 30 09.pdf

	 
	Log containing all IND submissions, contacts from Agency,
	 

	 
	contacts from Amgen, & listings of meeting dates. (PMO IND
	11709.xls

	 
	9837, HALT IND 11709)
	9837.xls

	 
	 
	 

	 
	 
	EMEA Guidleine on Osteoporosis rev 2-2005.pdf

	 
	Pertinent guidelines that were considered during development
	FDA 1994 osteo guidance.pdf

	 
	for the PMO clinical trials and non-clinical testing.
	M3 nonclincal safety studies.pdf

	 
	 
	 

	 
	 
	Day 80 AR Overview_except_CMC.pdf

	 
	120-day assessment (except CMC portion)
	Day 120 LoQ_except_CMC.pdf

	 
	80-day assessment (except CMC portion)
	CoRapporteur_D80AR_Overview_except_CMC.pdf

	Manufacturing
	 
	 

	and Controls
	 
	 

	 
	m3 from MAA
	m3

	 
	120 day questions (CMC)
	Prolia - Day 120 LoQ.pdf

	 
	A summary of the "120 day questions" from the FDA (CMC
	2009 04 205832f000.pdf

	 
	only).
	2009 04 2068db471a.pdf















	
			
	 
	Analytical method transfer reports from BI
	BPH15010R.pdf
BPH15012R.pdf
BPH15013R.pdf
BPH15027R.pdf
BPH15028R.pdf
BPH15043R.pdf
BPH15044R.pdf
BPH15170R.pdf
BPH15204R.pdf 
BPH1521R.pdf 
BPH16592R.pdf
BPH17241R.pdf
BPH18079R.pdf

	 
	Deck with data demonstrating the in-process control ranges for product titer.
	090715 Gazelle process consistency slides.ppt

	 
	Deck outlining strategy for responding to 120-day questions
(Quality)
	Denosumab Day 120 RTQ Strategy (Quality).ppt

	Compliance
	 
	 

	 
	Org Chart for quality
	Org Chart for GPQL.ppt

	 
	List of the high level SOPs covering quality systems in
Operations. Any document can be provided.
	Operating Standards.xls

	 
	Amgen Code of Conduct
	

Amgen_Code_of_Conduct.pdf

	 
	List of GCA QA Unit SOPs
	List of GCA QA Unit SOPs.doc

	 
	Global R&D Quality Manual
	

QM-000004.pdf

	 
	Development Training and Training Record Requirements
	

SOP-000713 Training .pdf

	 
	Submission of Clinical Trial Documents to REALM
	

SOP-000741 Archiving.pdf

	 
	R&D SOPS - Development standards, Global, Preclinical development ( for the current Dmab filing only Amgen SOPs were followed)
	R&D_SOP_TOC_13APR2009.pdf













	
			
	 
	GCQA Internal Process Audit Schedule for 2008 version 21 Dec 2007.doc

	 
	



Internal Audit Schedule for 2008 and 2009
	GCQA Internal Process Audit Schedule for 2009 version DD MMM YYYY for webpage.doc

	Intellectual
	 
	 

	Property/Legal
	 
	 

	 
	List of IP
	Collaboration_IP_list.pdf 
Expansion_IP_list.pdf 
Pending_opposition.pdf

	Discovery
	 
	 

	 
	SOPs that govern our biological data
	SOPs_wo PD.xls

	 
	List of Applications that capture, analyze, & store biological data.
	Subset_Discovery Science data systems List.xls

	Resources
	 
	 

	 
	Org Chart
	Org Chart and Alignment Activities.ppt

	Commercial
	 
	 

	 
	SmPC
	Final Submitted SmPC January 09.pdf

	 
	SmPC Comments and Proposed Changes from CHMP 120-day questions
	Day 120 SPC Labelling PL .pdf

	 
	Global Value Dossier (abridged)
	Denosumab_Global Value
Dossier_18Dec2008_DRAFT_abr.pdf

	Global Safety
	 
	 

	 
	Aggregate Safety Summaries
	

Denosumab CTSR 2009 Q1 Advanced Cancer.ppt
Denosumab_CTSR_2008_Q4_Oncology_2009-04-
06f.ppt

	 
	Overview of Hypoglycemia and Renal
	 















	
			
	 
	ONJ Narratives from the blinded Advanced Cancer studies
Pancreatitis Adverse Events summary
	denosumab_ONJ_20050103_20090612.RTF
denosumab_ONJ_20050136-20090611.RTF 
denosumab_ONJ_20050147_20090612.RTF 
denosumab_ONJ_20050244_20090612.RTF
20030216 Pancreatitis Observations .doc

	 
	SAE summaries for 4 trials
	Denosumab 200050103 All SAEs.pdf 
Denosumab 20050136 All SAEs.pdf 
Denosumab 20050147 All SAEs.pdf
Denosumab 20050244 All SAEs.pdf

















Schedule
Development Plan


	
												
	



Protocol # and
Description
	Type
	Study Objectives
	Study Design and Type of Control
	



Test
Products
	



Dosage Requirements
& Route of Admin
	# Patients per study
	Key entry criteria
	Duration of
Study (including follow-up)
	



Study
Status
	



Projected
Start Date
	



Projected
End Date

	20090371 - Int’l
Comparative Adherence Study (vs. weekly oral BP)
	Collaboration
Territory
R&D
	Amgen Non-IND Study
	not available
	not available
	not available
	1,000
	not available
	42-months
	Unfunded
	1/14/2011
	6/13/2014

	20090372 - Int’l
Comparative Adherence Study (vs.
monthly oral BP)
	Collaboration
Territory
R&D
	Amgen Non-IND Study
	not available
	not available
	not available
	1,000
	not available
	36-months
	Unfunded
	6/15/2011
	6/11/2014

	20090413 - Int’l
Prospective Observational Study
	Collaboration
Territory
R&D
	Amgen Non-IND
Study
	not available
	not available
	not available
	7,000
	not available
	48-months
	Unfunded
	6/15/2010
	6/10/2014

	20060289- 216
P3 extension
	Qualified
Amgen R&D
	To describe the safety
and tolerability of up to
10 years or 7 years of denosumab administration as measured by adverse event monitoring, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab
or placebo, respectively
	This is a multi-national, multi-center,
open-label, single-arm extension study enrolling subjects who have attended the month 36 visit in protocol 20030216. Only subjects who have completed the 20030216 study, are willing to receive denosumab and meet the inclusion/exclusion criteria will be eligible to participate in this study. There will be no control group for this study. All subjects who enroll in the study will receive open-label denosumab 60mg SC injections
every 6 months.
	N/A
	Open-Label denosumab:
60 mg SC injection will be administered either from pre-filled syringe or vial, at day 1, month 6, month 12, month 18, month 24, month 30, month 36, month 42, month 48, month 54, month 60, month 66, month 72 and month 78. All subjects will be instructed to take calcium supplements (containing approximately 1000 mg
of elemental calcium daily) and vitamin D (at least 400 IU daily) during the study.
	4,551
	All ambulatory
postmeno- pausal women who have attended the
20030216 month 36 visit, remain on investigational product and meet the inclusion/ exclusion criteria for this extension study as stated in Sections 4.1 and 4.2 will be eligible to participate.
	84-months
	Approved
Budget & Resources
	8/7/2007
	6/22/2015

	20080562- Transition Trial from Ibandronate
	Qualified
Amgen R&D
	Primary Objective: To evaluate the change in total hip Bone Mineral Density (BMD) at 12 months in
postmenopausal women transitioning from previous daily or weekly bisphosphonate therapy to denosumab
60mg SC Q6M compared to that in subjects transitioning to ibandronate 150mg
	This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States (US) and in Europe in postmenopausal women.
Approximately 800 subjects will be randomized across about 65 sites in a 1:1 ratio to either denosumab 60 mg SC Q6M, or ibandronate 150mg PO QM.
	Ibandronate
	denosumab 60mg SC Q6M
Control Group: Ibandronate 150mg PO QM
	800
	Postmeno- pausal women with osteo- porosis who have received
their first Rx of daily or weekly BP therapy at least 6 months but no more than 18 months
prior to screening. In addition,
eligible subjects
	20-months
	Approved Budget & Resources
	7/30/2009
	3/30/2011













	
												
	 
	 
	PO QM.
	 
	 
	 
	 
	will have stopped BP
treatment at least one month prior to screening or are still on treatment but
have insufficient adherence as measured by a score of less than 6 on the Osteo Specific
Morisky Medication Adherence Scale (OS- MMAS).
	 
	 
	 
	 

	20050233 - P2
223 extension
	Qualified
Amgen R&D
	Study 20050233 is an open-label extension study to Study
20010223. The primary objective of
this ongoing study (20050233) is to evaluate the long-term safety of denosumab administration in postmenopausal women with low BMD
who have completed parent Study
20010223. The secondary objective is to describe the treatment effect on
BMD and bone turnover markers (BTM) of long-term denosumab administration in these subjects.
	This multi-center, open-label, single- arm, extension study was designed to evaluate the long-term safety outcomes of denosumab administration in subjects who have
successfully completed parent Study
20010223. Study 20010223 enrolled postmenopausal women with low bone mass, corresponding to T- scores between -1.8 and -4.0 for the lumbar spine or between -1.8 and -
3.5 for the total hip or between -1.8 and -3.5 for the femoral neck. In Study 20050233, all subjects will receive denosumab 60 mg subcutaneously (SC) Q6M for 4 years (a total of 8 doses). Subjects also were instructed to take supplemental elemental calcium (≥
500 mg daily) and vitamin D (≥ 400
IU daily).
	N/A
	Denosumab was provided as a sterile, clear, colorless, preservative-free liquid in glass vials
containing 60 mg denosumab per mL of 10 mM sodium acetate and
5% sorbitol in Water for
Injection, with a pH of
5.2. One mL of denosumab was administered SC Q6M.
	200
	Required to be
≤ 80 years of age at the time of random- ization, not receiving medication that affected bone metabolism, and free from any underlying condition that might have resulted in abnormal bone metabolism.Po stmenopausal women who successfully completed parent Study
20010223, including the scheduled end- of-study visit, could
participate in
Study
20050233.
	60-months
	Approved Budget & Resources
	5/23/2006
	4/28/2011

	20080099 - Transition Trial from Risedronate
	Qualified
Amgen R&D
	The primary objective of the study is to evaluate the effect of denosumab 60 mg every 6 months (Q6M) compared with
Actonel® 150mg
	Study Design: This is a multi-center, international, randomized, open- label, parallel group study in post menopausal women with osteoporosis who have previously received daily or weekly oral
alendronate therapy but have
	Actonel® (Risedronate)
	Investigational Product Dosage and Administration: denosumab 60 mg Q6M SC and Actonel® 150 mg QM oral (one 75mg tablet
on each of 2 consecutive
	800
	Inclusion criteria include ambulatory, postmenopaus al women aged
55 years or
older who have
	23-months
	Unfunded
	9/30/2009
	7/27/2011















	
												
	 
	 
	monthly (QM) on total hip Bone Mineral
Density (BMD) at 12 months in postmenopausal women transitioning from previous alendronate therapy.
	demonstrated insufficient adherence to treatment. Approximately 800
subjects will be randomized across approximately 75 sites in a 1:1 ratio to either denosumab 60 mg Q6M SC or Actonel® 150 mg QM oral (one 75 mg tablet on each of 2 consecutive days).


Control group: Actonel® (Risedronate)
	 
	days each month).
	 
	experienced insufficient
adherence while receiving oral alendronate therapy.
	 
	 
	 
	 

	20080178 - P3
GIOP
	Qualified
Amgen R&D
	The primary objective of the study is to
evaluate the effect of denosumab 60 mg every 6 months (Q6M) compared with alendronate (ALN) 70 mg every week (QW)
on lumbar spine BMD at 12 months in glucocorticoid-treated men and women at increased risk of fracture.
	This is an international, multi-center, randomized, double-blind, double-
dummy, active-controlled, parallel- group study in men and women on long-term glucocorticoid therapy. Approximately 540 subjects will be enrolled. Subjects will be
randomized in a 1:1 allocation ration
to receive either:
 denosumab 60 mg subcutaneous (SC) injection every 6 months and oral placebo for alendronate once a week for 24 months
 oral alendronate 70 mg once a week and placebo for denosumab subcutaneous (SC) injection every 6 months for 24 months
	Oral
Alendronate
	Denosumab 60mg SC Q6M
 Alendronate 70mg PO QW
 Placebo for denosumab injection
 Placebo for alendronate oral tablet
	534
	Ambulatory men and
women who have initiated ≥
5 mg per day of prednisone or
its equivalent and expect to
maintain this dose level or higher for 12 months. Additionally, these subjects
will be required to have bone mineral density values at the lumbar spine or total hip in the protocol
specified range.
	34-months
	Unfunded
	10/15/10
	8/11/2013

	20080098 - Male Osteo
	Qualified
Amgen R&D
	Primary Objective: The primary objective is to evaluate the
effect of denosumab compared to that of placebo on lumbar spine BMD at 12 months in men with low bone mass.
	This a phase 3, multi-center, randomized, double blind placebo controlled study in men with low
bone mass. A total of 232 subjects will be enrolled into the study with a treatment duration of 24 months (12 months placebo-controlled followed by a 12 month open-label phase in which all subjects will receive denosumab). All subjects will receive
daily supplementation with calcium (at least 1000 mg) and vitamin D (at least 800 IU) through month 24. Upon meeting all eligibility criteria subjects will be randomized to receive one of two treatments,
denosumab or placebo at Day 1 and
Month 6. For the open-label phase all subjects will receive denosumab at Month 12 and Month 18.
	N/A
	Subjects will receive subcutaneous (SC) injections of either
denosumab 60 mg or placebo on Day 1 and Month 6.  All subjects will receive denosumab at Month 12 and 18.
	232
	Ambulatory men 30 to 85 years of age
inclusive with BMD values (g/cm2), assessed at the local site that correspond to
T-score £ -2.0
and 3 -3.5 at the lumbar spine or femoral neck
OR  a T-score
£ -1.0 and 3 -
2.0 at the lumbar spine or femoral neck in subjects with a prior history of fragility
fracture.  Refer to Sections 4.1
	34-months
	 
	9/30/2009
	6/27/2012















	
												
	 
	 
	 
	 
	 
	 
	 
	and 4.2 for detailed
inclusion/ exclusion criteria.
	 
	 
	 
	 

	GRAS Safety
Studies-
20090286 - Denosumab Methodology
and Background Assessment (DMBA)
	Qualified
Amgen R&D
	The overall purpose is
to design and execute analyses based upon data from the pre- launch period to support the validity of the denosumab post- marketing pharmacovigilance study in post- menopausal osteoporosis (PMO).
	This is a retrospective cohort study
to be conducted using Nordic Country National Health Registry System databases, including data from Denmark, Finland, Sweden and Norway. The study period (over which data from the pre-launch period will be collected) will begin January 1, 2005, and will continue through December 31, 2009. Depending upon data availability,
this study period may vary over the selected countries.  Patients will be followed for at least one year and up to five years.  The study will be completed by the end of 2010. Findings from this study will inform the design and implementation of the denosumab post-marketing safety assessment based on Nordic
Country National Health Registry
Systems.
	N/A
	 
	Based on
census data from the four countries, there are approx 2.4 million women aged 65 years or older.  If the study includes female population
between 55 and 64 years old, the sample size will be more than
3 million. Given the expected large sample size, this study will be able to evaluate incidence of rare events.
	PMO women,
enrolled in one of the four Nordic Country National Health Registry Systems, and meeting the
pre-defined PMO diagnostic between January 1,
2005 and
December 31,
2009 will be eligible for inclusion in these analyses.
	72-months
	 
	1/1/2005
	12/31/2010

	GRAS Safety
Studies -
20090287 - Denosumab Post-Marketing Global Safety Assessment (DPMGSA)
	Qualified
Amgen R&D
	The proposed study will be conducted in two phases. Objectives of the
Phase 1 studies are to:
1. Characterize potential denosumab users in PMO populations and likely
comparator groups.
2. Establish and test the validity of algorithms for identifying PMO populations, determining PMO
	Cohort analyses in 3 US data systems and 4 Nordic countries will be proposed.  In Phase 1, data will be analyzed for the period January
2005 until the launch of denosumab (or a 5 year period) in the respective countries.  For Phase 2, data will be collected for a 5 year period starting
6 months after launch.
	N/A
	 
	The number of dmab- exposed
patients in the five year post- launch period can be
estimated as the sum of: (i)
62,500-
125,000 women aged 65
	Eligibility will be limited to post- menopausal women with a
diagnosis of osteoporosis. Identification of such women will be based
on a validated
algorithm developed during Phase 1, which will generally include diagnostic
	72-months
	Unfunded
	1/1/2005
	12/31/2010















	
												
	 
	 
	severity and
ascertaining the
occurrence of study
events of interest.
3. Describe
background incidence
rates of study events
of interest using
validated case
ascertainment
algorithms among
potential denosumab
exposed populations
and likely comparator
groups.
The results from
Phase 1 will support
the evaluation of
events of interest in
Phase 2.
Objectives of the
Phase 2 studies are
to:
1. Describe and
compare, after
appropriately adjusting
for relevant
confounding factors,
incidence rates of
events of interest in
denosumab exposed
and unexposed PMO
women.
2. Describe
denosumab utilization
patterns (dosage,
frequency, length of
utilization, stop /
switch treatment) in
PMO women receiving
denosumab therapy.
3. Describe patient
characteristics and
clinical features of
PMO women treated
with denosumab.
	 
	 
	 
	years and
older within
Medicare;
(ii) approx
30,000
within
Kaiser; (iii)
approx
50,000 in
United
HealthCare
; and (iv)
approx
240,000 in
the Nordic
registries.
This will
provide the
capability
to evaluate
rare events
within each
data
system or
in
combined
analyses.


	codes
indicating PMO
in the specific
data system,
and/or
procedures or
relevant PMO
treatment, in
combination
with age criteria
(eg, 55 years or
older). Patients
will be excluded
if they have a
history of
cancer prior to
their initiation of
denosumab or
other PMO
therapies.


	 
	 
	 
	 





















Press Release Schedule















Privilege Agreement Schedule


JOINT COMMUNITY OF INTEREST PRIVILEGE AGREEMENT


This Agreement (“this Agreement”) by and between Amgen Inc. (“Amgen”) and Glaxo Group Limited (“GSK”).  Amgen and GSK each may be referred to herein as a “Party,” or collectively as the “Parties.”


RECITALS


WHEREAS, Amgen and GSK are entering into separate agreements of even date herewith under which the Parties shall collaborate with respect to the commercialization of Ivory in certain territories as specified therein (the “Collaboration Agreement”) and under which GSK will conduct certain activities with respect to Ivory in certain expansion territories as specified therein (the “Expansion Territory Agreement”);


WHEREAS, the Parties are of the opinion that it has been and from time-to-time it may be desirable or beneficial to the Parties to share with their respective Counsel and to allow their respective Counsel to share privileged and/or work product information with respect to certain intellectual property in which the Parties have an interest and legal matters relating thereto and with respect to certain third party intellectual property;


WHEREAS, the Parties acknowledge that they share a common interest in the prosecution, defense and enforcement of such intellectual property, and assessing the validity, enforceability and coverage of certain third party intellectual property;


WHEREAS, this Agreement is intended to protect any shared privileged and/or work product information relating to such intellectual property and maintain the privileged and/or attorney work product immunity status of such information against disclosure to third parties;


NOW THEREFORE, the Parties, based upon the continuing obligation of each party to another, hereby agree and set forth the following:


		
	1.
	Definitions: For purposes of this Agreement, the following terms shall have the following meanings:




1.1.    “Common Interest” shall mean the community of legal interest shared by the Parties arising from their collaborative efforts in regards to a) the Collaboration Agreement, the Expansion Territory Agreement and related research, development, licensing, manufacturing, marketing, and commercialization efforts (collectively referred to as the “Intellectual Property Agreements”); b) joint and/or several patent prosecution, defense or enforcement; c) analysis and evaluation of certain intellectual property rights; and d) anticipated, threatened, or actual disputes, litigation or other proceedings related to the Parties, and preparation therefore, including but not limited to disputes, litigation and other proceedings related directly or indirectly to the Intellectual Property Agreements; patent prosecution, defense or enforcement; or analysis of third-party intellectual property rights.









1.2.    “Patents” shall mean (a) all patents and patent applications; (b) any substitutions, divisions, requests for continued examination, continuations, continuations- in-part, reissues, renewals, registrations, confirmations, re-examinations, divisionals, extension, supplementary protection certificates and the like, and any provisional applications, of any such patents or patent application; and (c) any foreign or international equivalents of any of the foregoing, related to the Parties’ Common Interest, including patents of the Parties and third parties.


1.3.    “Counsel” shall mean and include any law trained person, including any attorney, patent attorney, patent agent, solicitor, barrister, or any other person, including experts or consultants, assisting such law trained person, whether in-house or outside counsel, and representing any Party or any Party’s past, present and future parents, subsidiaries, successors, predecessors and affiliated companies (“Related or Affiliated Entities”).


1.4.    “Party” shall mean any of the Parties to this Agreement, as well as their Related or Affiliated Entities.


1.5.    “Privileged Materials” shall mean communications and information embodied in any form, whether oral or written, including without limitation, communications and information exchanged among the respective counsel of the Parties or among the Parties and Counsel concerning the Parties’ Common Interest, or derived therefrom which would otherwise qualify as privileged communications as against third persons.  These materials include, without limitation, documents, specific pieces of prior art, things, information, mental impressions, factual materials, memoranda, opinions of counsel, communications among Counsel, communications among the Parties and
Counsel, analyses of claims or defenses, analyses of legal strategy or tactics, interview reports, and experts’ reports.


2.    Sharing of Materials: The Parties agree that certain Privileged Materials have been and in the future may be shared by the Parties’ respective Counsel in furtherance of their Common Interest.  The Parties also agree that the sharing of Privileged Materials, prior to or after the effective date of this Agreement, is not intended to and shall not constitute a waiver of any applicable privilege, immunity or protection, which would otherwise apply to the Privileged Materials.  Nor shall the exchange of Privileged Materials between the Parties defeat claims or constitute a waiver of privilege or work product protection, or impair the confidentiality of such Privileged Materials.


3.    Retained Rights As Against Third Parties: Each Party retains the right to assert any and all privileges, immunities, and protections against non-parties to this Agreement with respect to the Privileged Materials that originated from it that have been shared among the respective counsel of the Parties or among the Parties and Counsel concerning the Parties’ Common Interest.  Each Party also retains the right to waive any and all privileges and protections against non-parties to this Agreement with respect to shared Privileged Materials that originated from it.


4.    Use of Materials: The Parties agree that Privileged Materials, disclosed pursuant to this Agreement, may be used for the purposes set forth in the Intellectual Property









Agreements and in furtherance of the Common Interest and for no other purpose. However, a Party may use any prior art without obtaining the prior written consent of the furnishing party.  Subject to the terms or provisions of the Intellectual Property Agreements, each Party retains the right to use all of the Privileged Materials it has furnished to other parties for any purpose.


5.    Labeling of Materials: Whenever possible, Privileged Materials shall be labeled as “Privileged Materials,” but failure to so label any materials shall not exclude those materials from the scope of Privileged Materials and shall neither constitute a waiver of any privilege nor a waiver of any protection, right or obligation provided for in this Agreement.


6.    Prohibited Disclosure by Receiving Party: Each Party has the obligation to assert any and all privileges and protections against non-parties to this Agreement with respect to the Privileged Materials that originated from the other Party to this Agreement.  Opinions, conclusions or work product, based upon or derived from the information contained in received Privileged Materials shall constitute Privileged Materials and no Privileged Materials shall be furnished by the receiving Party to any non-party to this Agreement without the prior written consent of the furnishing Party or court order.


7.    Use Against Party: No Privileged Materials exchanged pursuant to this Agreement shall be used against a Party to this Agreement, unless (a) such materials no longer qualify as privileged communications as against third persons or (b) such materials originated
from the Party seeking to use them, and such materials were in no way derived from
Privileged Materials of the other Party and exchanged under this Agreement.


8.    Continued Confidentiality: Parties and their respective Counsel agree that Privileged Materials communicated under this Agreement shall continue to be held confidential and subject to privilege even if adversity of interest may subsequently be discerned or arise between them, unless (a) such materials no longer qualify as privileged communications as against third persons or (b) such materials originated from the Party seeking to remove them from the confidentiality requirements of this agreement and such materials were in no way derived from Privileged Materials of another Party and exchanged under this Agreement.


9.    Response to Subpoena for Privileged Materials: If any other person or entity not a Party hereto requests or demands, by subpoena or otherwise from a Party, any Privileged Materials received from a Party hereto, the Party receiving such request or demand shall 1) immediately notify the Party whom originally conveyed the requested Privileged Materials; 2) assert the community of interest privilege, the attorney/client privilege and/or work product immunity as applicable; and 3) will take all steps reasonable and necessary (including, without limitation, making all appropriate objections and motions) to maintain the assertion of all applicable rights and privileges with respect to all Privileged Materials received by it, and shall cooperate fully with the other Party in any proceeding relating to the possible disclosure of any portion of the Privileged Materials.  The Party from whom the Privileged Materials originated shall pay any fees and costs arising in accordance with step 3), if that Party wishes to maintain the assertion of applicable rights and privileges of the Privileged Materials.









10.    No Disqualification of Counsel: Neither this Agreement nor the sharing of Privileged Materials shall be grounds for seeking the disqualification of any Party’s Counsel.


11.    Effective Date.  No Effect Upon Other Agreements: This Agreement shall be effective as of January 28, 2009 and shall continue in force until terminated by mutual agreement of the Parties in writing.  Entry into this Agreement shall not affect or alter any other obligations or agreements between the Parties hereto which now exist or which will come into existence in the future.  Moreover, nothing in this Agreement shall affect any obligation of the Parties to share documents or information or otherwise create any obligation on the part of any Party to share or disclose materials, whether privileged or not.


12.    Withdrawal from Agreement: Any Party to this Agreement desiring to withdraw from this Agreement may do so “at will” and at any time by providing fifteen (15) days written notice of withdrawal to the other Party.  In the event a Party withdraws from this Agreement, the withdrawing Party shall promptly return all physical copies of Privileged Materials provided pursuant to this Agreement, to the Party which originally provided the Privileged Materials. Any withdrawal does not affect the obligations relating to maintenance of the privilege and/or confidentiality of Privileged Materials received by such withdrawing Party pursuant to this Agreement.  Moreover, any Party which withdraws from participation in this Agreement must continue to assert the privileges and work product protections with respect to all Privileged Materials received by such Party prior to such Party’s withdrawal unless and until such privileges and protections are expressly waived by the remaining Party, and shall continue to abide by the provisions provided in paragraph 9 above in the event that any non-party to this Agreement requests that the withdrawing party disclose any Privileged Materials subject to this Agreement.


13.    No Waiver: Nothing in this Agreement shall be construed as a waiver of any right to assert privilege that a Party to this Agreement may otherwise have.  Furthermore, nothing in this Agreement shall constitute a transfer or conveyance of any ownership or other proprietary rights a Party may have in documents, things or other information exchanged in accordance with this Agreement.


14.    Successors and Assigns: This Agreement shall be binding on the Parties hereto, their Counsel, officers, directors and employees as well as their respective successors and assigns.


15.    Equitable Relief: The Parties agree that there exists no adequate remedy at law for breach of this Agreement and that specific performance or injunctive relief are appropriate remedies to compel performance hereunder.


16.    Separate Acknowledgments: The Acknowledgments may be executed separately, each of which shall be deemed an original but all of which together shall comprise one agreement.


17.    Confidentiality of Agreement: The existence and terms of this Agreement are confidential and shall not be disclosed to any person or entity other than the Parties hereto and their respective Counsel, without the prior written consent of each of the Parties.









However, if pursuant to legal process, it becomes necessary to disclose the existence of this Agreement (e.g., in response to litigation discovery processes where a log of privileged documents must be submitted), then the mere existence of this Agreement may be disclosed without disclosure of any terms hereof.  Any such disclosure shall not constitute a waiver of any privilege, immunity or protection applying to any Privileged Materials covered by this Agreement.


18.    Governing Law: This Agreement will be governed by, and enforced and construed in accordance with, the laws of the State of New York without regard to its conflicts of law provisions.


19.    Notices: Any notices to be provided under this Agreement shall be given by mail to each Party at the address indicated in the Acknowledgment executed by the Party.


20.    No Effect on Intellectual Property Agreements: Nothing in this Agreement shall affect the operation or interpretation of the Intellectual Property Agreements.  In the event of any conflict between the terms or provisions of this Agreement and the terms or provisions of the Intellectual Property Agreements, the terms and provisions of the Intellectual Property Agreements shall prevail.









ACKNOWLEDGMENT


By execution of this Acknowledgment, the Parties identified herein agree to be bound by the terms of this Agreement.


	
		
	 
	Amgen Inc.

	 
	 

	Dated:                    , 2009
	By: ________________________________________

	 
	Name:

	 
	Title:

	 
	 

	 
	 

	 
	Glaxo Group Limited

	 
	 

	Dated:                    , 2009
	By: ________________________________________

	 
	Name:

	 
	Title:























Inventorship Margin and Profit (Loss) True-Up Calculation Schedule


This schedule provides examples of the calculation of the Inventorship Margin pursuant to Section 1.70 (“Inventorship Margin”) and the calculation of the Profit (Loss) True-Up pursuant to Section 6.1.8 (Calculation of Profit (or Loss)).


I.    Inventorship  Margin.    Assume,  for  purposes  of  this  example  that  Ivory  Net Revenues, cumulative calendar year YTD Ivory Net Revenues and portions of cumulative calendar year YTD Ivory Net Revenues that are (A) less than or equal to $450,000,000, (B) greater than $450,000,000 but less than or equal to $900,000,000 and (C) greater than $900,000,000, are each as set forth in the table below:


	
													
	 
	Q1 2017
	Q2 2017
	Q3 2017
	Q4 2017

	Quarterly Ivory Net Revenues:
	$
	200,000,000
	

	$
	300,000,000
	

	$
	450,000,000
	

	$
	500,000,000
	


	Cumulative Calendar Year YTD
Ivory Net Revenues:
	$
	200,000,000
	

	$
	500,000,000
	

	$
	950,000,000
	

	$
	1,450,000,000
	


	Portion of Calendar Year YTD
Ivory Net Revenues:
	 
	 
	 
	 

	< $450M (10% IM):
	$
	200,000,000
	

	$
	250,000,000
	

	$
	—
	

	$
	—
	


	> $450M < $900M (5% IM):
	$
	—
	

	$
	50,000,000
	

	$
	400,000,000
	

	$
	—
	


	> $900M (2.5% IM):
	$
	—
	

	$
	—
	

	$
	50,000,000
	

	$
	500,000,000
	







Taking the third and fourth quarters as representative examples, the Inventorship Margin would be calculated as follows:


In Q3 2017, quarterly Ivory Net Revenues are $450,000,000 and cumulative calendar year YTD Ivory Net Revenues are $950,000,000.   Since portions of the $450,000,000 in Q3 2017 Ivory Net Revenues constitute cumulative calendar year YTD Ivory Net Revenues between $450,000,000 and $900,000,000 (inclusive), while the balance constitute cumulative  calendar  year  YTD  Ivory  Net  Revenues  greater  than  $900,000,000,  two different  rates  of  Inventorship  Margin  are  applied.    The  5%  rate  is  applied  to  the $400,000,000 in Q3 2017 Ivory Net Revenues representing cumulative calendar year YTD Ivory Net Revenues between $450,000,000 and $900,000,000 (inclusive), and the 2.5% rate is applied on the balance.   The Inventorship Margin for the quarter is therefore $21,250,000 ($400,000,000 x 0.05 + $50,000,000 x 0.025 = $21,250,000).


In Q4 2017, quarterly Ivory Net Revenues are $500,000,000 and cumulative calendar year YTD Ivory Net Revenues are $1,450,000,000. Since all $500,000,000 in Ivory Net Revenues  in  Q4  2017  constitute  cumulative  calendar  year  YTD  Ivory  Net  Revenues greater than $900,000,000, the Inventorship Margin percentage of 2.5% is applied to all Q4 2017  Ivory  Net  Revenues.     The  Inventorship  Margin  for  the  quarter  is  therefore $12,500,000 ($500,000,000 x 0.025 = $12,500,000).















II.    Collaboration Profit (Loss).   Next, in order to determine the Collaboration Profit (Loss) in accordance with Section 6.1.8, one must determine the total collaboration costs for the quarter.


A.    Collaboration Profit Examples.


Assume  for  purposes  of  this  example  that  in  Q4  2017  Ivory  Net  Revenues  are $500,000,000  and  the  Inventorship  Margin  is  $12,500,000  (consistent  with  the  example above).  Further assume that the total collaboration costs are $150,000,000 and both Amgen Costs and GSK Costs are $75,000,000.  In such a case, the Collaboration Profit (Loss) for Q4 2017 would be $337,500,000, and each Party’s share of the Collaboration Profit (Loss) would be  $168,750,000  ($500,000,000  -  $12,500,000  -  $150,000,000  =  $337,500,000  /  2  = $168,750,000).


In this example, of the $500,000,000 in Q4 2017 Ivory Net Revenues, GSK would be entitled to a true-up payment of $243,750,000, representing GSK’s share of the Collaboration Profit  (Loss)  plus  reimbursement  of  the  GSK  Costs  ($168,750,000  +  $75,000,000  = $243,750,000), which would provide GSK with a net profit of $168,750,000 for the quarter, and Amgen would be entitled to the remaining $256,250,000, representing Amgen’s Inventorship Margin plus Amgen’s share of the Collaboration Profit (Loss) plus the Amgen Costs ($12,500,000 + $168,750,000 +   $75,000,000 = $256,250,000), which would provide Amgen  with  a  net  profit  of  $168,750,000  for  the  quarter  (not  counting  the  Inventorship Margin).




	
						
	 
	Total
	 
	Amgen
	 
	GSK

	Net Revenues
	$500,000,000
	 
	$500,000,000
	 
	—

	Inventorship Margin
	$(12,500,000)
	 
	$(12,500,000)
	 
	—

	Collaboration Costs
	$(150,000,000)
	 
	$(75,000,000)
	 
	$(75,000,000)

	Collaboration Profit
	$337,500,000
	 
	$412,500,000
	 
	$(75,000,000)

	True-Up Payment
	 
	 
	$(243,750,000)
	 
	$243,750,000

	Share of Profit (Loss)
	$337,500,000
	 
	$168,750,000
	 
	$168,750,000






If, however, the collaboration costs that had been incurred by each Party in the quarter differed, then each Party’s share of the Ivory Net Revenues for the quarter would need to be adjusted.


For  example,  if  in  the  example  above,  the  total  collaboration  costs  were  still $150,000,000, but the GSK Costs were $35,000,000 and the Amgen Costs were $115,000,000, then each Party’s share of the Collaboration Profit (Loss) would still be $168,750,000 ($500,000,000 - $12,500,000 - $150,000,000 = $337,500,000 / 2 = $168,750,000) and GSK would be entitled to a true-up payment of $203,750,000, representing GSK’s share of the Collaboration   Profit   (Loss)   plus   reimbursement   of   the   GSK   Costs   ($168,750,000   + $35,000,000 = $203,750,000), which would provide GSK with a net profit of $168,750,000 for the  quarter,  and  Amgen  would  be  entitled  to  the  remaining  $296,250,000,  representing Amgen’s Inventorship Margin plus Amgen’s share of the Collaboration Profit (Loss) plus the Amgen Costs ($12,500,000 + $168,750,000 + $115,000,000 = $296,250,000), which would













provide Amgen with a net profit of $168,750,000 for the quarter (not counting the Inventorship
Margin).


	
						
	 
	Total
	 
	Amgen
	 
	GSK

	Net Revenues
	$500,000,000
	 
	$500,000,000
	 
	—

	Inventorship Margin
	$(12,500,000)
	 
	$(12,500,000)
	 
	—

	Collaboration Costs
	$(150,000,000)
	 
	$(115,000,000)
	 
	$(35,000,000)

	Collaboration Profit
	$337,500,000
	 
	$372,500,000
	 
	$(35,000,000)

	True-Up Payment
	 
	 
	$(203,750,000)
	 
	$(203,750,000)

	Share of Profit (Loss)
	$337,500,000
	 
	$168,750,000
	 
	$168,750,000






If, on the other hand, in the example above the total collaboration costs were still $150,000,000, but the GSK Costs were $100,000,000 and the Amgen Costs were $50,000,000, then each Party’s share of the Collaboration Profit (Loss) would still be $168,750,000 ($500,000,000 - $12,500,000 - $150,000,000 = $337,500,000 / 2 = $168,750,000) and GSK would be entitled to a true-up payment of   $268,750,000, representing GSK’s share of the Collaboration   Profit   (Loss)   plus   reimbursement   of   the   GSK   Costs   ($168,750,000   + $100,000,000 = $268,750,000), which would provide GSK with a net profit of $168,750,000 for the quarter, and Amgen would be entitled to the remaining $231,250,000, representing Amgen’s Inventorship Margin plus Amgen’s share of the Collaboration Profit (Loss) plus the Amgen Costs ($12,500,000 + $168,750,000 + $50,000,000 = $231,250,000), which would provide Amgen with a net profit of $168,750,000 for the quarter (not counting the Inventorship Margin).


	
						
	 
	Total
	 
	Amgen
	 
	GSK

	Net Revenues
	$500,000,000
	 
	$500,000,000
	 
	—

	Inventorship Margin
	$(12,500,000)
	 
	$(12,500,000)
	 
	—

	Collaboration Costs
	$(150,000,000)
	 
	$(50,000,000)
	 
	$(100,000,000)

	Collaboration Profit
	$337,500,000
	 
	$437,500,000
	 
	$(100,000,000)

	True-Up Payment
	 
	 
	$(268,750,000)
	 
	$268,750,000

	Share of Profit (Loss)
	$337,500,000
	 
	$168,750,000
	 
	$168,750,000






B.    Collaboration Loss Examples.


Assume  for  purposes  of  this  example  that  in  Q4  2017  Ivory  Net  Revenues  are $40,000,000,  the  Inventorship  Margin  is  $4,000,000  and  the  total  collaboration  costs  are $160,000,000,  of  which,  the  Amgen  Costs  are  $110,000,000  and  the  GSK  Costs  are $50,000,000.    In  such  a  case,  the  Collaboration  Profit  (Loss)  for  Q4  2017  would  be -$124,000,000,  and  each  Party’s  share  of  the  Collaboration  Profit  (Loss)  would  be -$62,000,000   ($40,000,000   -   $4,000,000   -   $160,000,000   =   -$124,000,000   /   2   = -$62,000,000).













In this example, without further adjustment, Amgen would have incurred $74,000,000 in losses ($40,000,000 - $4,000,000 - $110,000,000 = -$74,000,000) and GSK would have incurred $50,000,000 in losses (representing the GSK Costs of $50,000,000).   Since each Party’s share of the Collaboration Profit (Loss) for the quarter should be -$62,000,000, as shown in the preceding paragraph, GSK would owe Amgen a true-up payment of $12,000,000, which would provide Amgen with a net loss of $62,000,000 for the quarter ($40,000,000 - $4,000,000  -  $110,000,000  +  $12,000,000  =  -$62,000,000)  and  GSK  with  a  net  loss  of $62,000,000 for the quarter (-$50,000,000 - 12,000,000 = -$62,000,000).


	
						
	 
	Total
	 
	Amgen
	 
	GSK

	Net Revenues
	$40,000,000
	 
	$40,000,000
	 
	—

	Inventorship Margin
	$(4,000,000)
	 
	$(4,000,000)
	 
	—

	Collaboration Costs
	$(160,000,000)
	 
	$(110,000,000)
	 
	$(50,000,000)

	Collaboration Profit
	$(124,000,000)
	 
	$(74,000,000)
	 
	$(50,000,000)

	True-Up Payment
	 
	 
	$120,000,000
	 
	$(12,000,000)

	Share of Profit (Loss)
	$(124,000,000)
	 
	$(62,000,000)
	 
	$(62,000,000)






If, on the other hand, in the example above the total collaboration costs were still $160,000,000, but the GSK Costs were $100,000,000 and the Amgen Costs were $60,000,000, then    each    Party’s    share    of    the    Collaboration    Profit    (Loss)    would    still    be -$62,000,000   ($40,000,000   -   $4,000,000   -   $160,000,000   =   -$124,000,000   /   2   = -$62,000,000) and, without further adjustment, Amgen would have incurred $24,000,000 in losses  ($40,000,000  -  $4,000,000  -  $60,000,000  =  -$24,000,000)  and  GSK  would  have incurred $100,000,000 in losses (representing the GSK Costs of $100,000,000).   Since each Party’s share of the Collaboration Profit (Loss) for the quarter should be -$62,000,000, Amgen would owe GSK a true-up payment of $38,000,000, which would provide GSK with a net loss of $62,000,000 for the quarter (-$100,000,000 + $38,000,000 = -$62,000,000) and Amgen with a  net  loss  of  $62,000,000  for  the  quarter  ($40,000,000  -  $4,000,000  -  $60,000,000  - $38,000,000 = -$62,000,000).


	
						
	 
	Total
	 
	Amgen
	 
	GSK

	Net Revenues
	$40,000,000
	 
	$40,000,000
	 
	—

	Inventorship Margin
	$(4,000,000)
	 
	$(4,000,000)
	 
	—

	Collaboration Costs
	$(160,000,000)
	 
	$(60,000,000)
	 
	$(100,000,000)

	Collaboration Profit
	$(124,000,000)
	 
	$(24,000,000)
	 
	$(100,000,000)

	True-Up Payment
	 
	 
	$(38,000,000)
	 
	$38,000,000

	Share of Profit (Loss)
	$(124,000,000)
	 
	$(62,000,000)
	 
	$(62,000,000)





















Schedule


Amgen Disclosures






Matters or items included on this Amgen Disclosures Schedules are not necessarily limited to the items required by the Agreement to be disclosed in this Amgen Disclosures Schedule. Such additional matters are set forth for informational purposes.  Nothing in this Amgen Disclosures Schedule shall constitute an admission of any liability or obligation of Amgen to any third party, nor constitute an admission to any third party against Amgen’s interests, nor constitute an admission or otherwise imply that any item or information on this Amgen Disclosures Schedule is material or creates a measure for materiality.


EP 0951551      Immunex Corp.  Opposed in EPO EP 0975754      Amgen Inc.   Opposed in EPO
EP 0911342      Daiichi Sankyo Co. Ltd., licensed to Amgen Inc.  Opposed in EPO EP 1257648      Amgen Inc.  Opposed in EPO


EP 1114864      Schering Corp.  Opposed in EPO


US 6,410,516    Assigned to President & Fellows of Harvard College, Massachusetts Institute of Technology, and Whitehead Institute for Biochemical Research.  Licensed to Ariad Pharmaceuticals, Inc.
Certain claims of the ‘516 patent were found to be not infringed (Amgen Inc. v. Ariad Pharmaceuticals, Inc.), certain claims of the ‘516 patent were found to be invalid (Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.).


US 6,528,313 and US 6,638,768       Both assigned to Institut Pasteur, licensed to Cellectis SA. Letter from Cellectis SA to Amgen Inc. dated June 18, 2009













Sales Forecast Schedule


	
							
	Year
	2010
	2011
	2012
	2013
	2014
	2015

	Sales
($MM)
	32
	129
	290
	480
	667
	951






	
								
	Year
	2016
	2017
	2018
	2019
	2020
	2021
	2022

	Sales
($MM)
	1193
	1338
	1435
	1531
	1612
	1660
	1685























Tail Payment Schedule




This schedule provides an example of the calculation of the Tail Payment pursuant to Section
14.11 (Tail Payment).


For the purposes of this example, assume the following Ivory Net Revenues:


	
				
	 
	2022
	2023
	2024

	Ivory Net Revenues:
	$1,600,000,000
	$1,700,000,000
	$1,500,000,000






In order to determine the relevant Tail Payment, first the GSK 2022 Profit Share must be calculated.


Assuming a total profit (after deducting the Inventorship Margin, GSK Costs and Amgen Costs) of $750,000,000 (i.e. the Inventorship Margin plus GSK Costs plus Amgen Costs equal $850,000,000), then, pursuant to the formula set forth in Section 14.10.3, the GSK 2022 Profit Share is 23.44% (50% * $750,000,000 / $1,600,000,000).


This GSK 2022 Profit Share is then used to calculate the Tail Payments to be made for 2023 and 2024.  Given the hypothetical Ivory Net Revenues set forth above, the payment amounts for 2023 and 2024 are as follows:


	
			
	Period
	Formula
	Amount

	2023
	40% * $1,700,000,000 * 23.44%
	$159,392,000

	2024
	30% * $1,500,000,000 * 23.44%
	$105,480,000















Amendment No. 1 to Collaboration Agreement
This amendment to the Collaboration Agreement (this “Amendment”) is made and entered into as of the 24th day of January, 2012 (the “Execution 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”).
WITNESSETH:
WHEREAS, GSK and Amgen entered into a Collaboration Agreement dated July 27, 2009 (the “Agreement”), governing GSK's rights to commercialize Ivory in the Collaboration Territory; and    
WHEREAS, the Parties desire to amend the Agreement with respect to certain matters relating to Product Trademarks and brand security, among other things, pursuant to Section 16.19 of the Agreement, as set forth below.
NOW THEREFORE, in consideration of the covenants and obligations expressed herein, and intending to be legally bound, the Parties agree as follows:
	
		
	1.
	Capitalized terms used but not defined herein have the meanings ascribed to them in the Agreement.



	
		
	2.
	Section 10.2 is hereby deleted in its entirety and replaced with the following language:




“Brand Security and Anti-Counterfeiting. The Parties will establish contacts for communication regarding brand security issues and will each reasonably cooperate with the other with respect thereto. The Parties will develop and implement an anti-counterfeiting strategy with respect to Ivory in the Collaboration Territory, including the following elements: (i) agreement on a counterfeit incident management process enabling the most effective response to incidents of suspected counterfeit Ivory and (ii) using a risk-based approach, identification of countries in the Collaboration Territory where Amgen will record its right to use the Product Trademark with the applicable governmental customs authorities and provide authority training. In the event that a Party becomes aware of suspected counterfeit Ivory in the Collaboration Territory, the Party with such knowledge shall promptly notify the other Party in writing using reasonable efforts to do so within five (5) business days, except in cases where local law requires a more prompt response (e.g., with respect to an inquiry from a local customs authority wherein response times may be very short), in which case the Parties shall endeavor to give written notice more promptly. After such written notice, the Parties shall confer and endeavor to reach consensus as to a mutually acceptable response to the counterfeit Ivory in accordance with the counterfeit incident management process agreed to by the Parties. Such response may include further investigation, referral to drug regulatory authorities and/or law enforcement, cooperation with customs authorities, test purchases, obtaining of legal advice, sending a cease and desist letter and/or a decision not to take any action. In the event that the Parties cannot reach consensus as to the response to the counterfeit Ivory within sixty (60) days after written notice, or sooner if specifically required to preserve the right to act under Applicable Law, the Parties agree as follows: (i) Amgen will have the first right to take action with respect to such counterfeit Ivory, but only based on Product Trademarks and Amgen Housemarks, and shall not assert or otherwise rely on GSK Housemarks without GSK's prior written consent; and (ii) GSK will have the second right to take action with respect to such counterfeit Ivory where Amgen decides not to act, but only based on GSK Housemarks, and shall not assert or otherwise rely on Product Trademarks and/or Amgen Housemarks without Amgen's prior written consent; provided, that, in each case, the other Party will take reasonable steps, if and as directed by the Party wanting to take action and at such Party's sole expense, with respect to such suspected counterfeit Ivory. For the sake of clarity, nothing in this Section 10.2 shall in any way limit, nor is intended to so limit, the rights of Amgen with respect to any portion of the Ivory Intellectual Property as provided in other provisions of this Agreement, unless expressly agreed by the Parties in writing.”
	
		
	3.
	Section 9.11.3.2 of the Agreement is hereby amended to read in its entirety as follows:




“To Amgen. GSK hereby grants to Amgen a non-exclusive, royalty-free license to use the GSK Housemarks (i) as set forth in the Promotional Materials (including monographs) solely to Detail Ivory in the Collaboration Scope in accordance with the Brand Plan, Country Plans and this Agreement, and (ii) to the extent permissible in accordance with Applicable Law, on the labeling, packaging and package inserts for Ivory in the Collaboration Scope. Amgen's right to use the GSK Housemarks will terminate, on a country-by-country basis, when GSK's rights to promote Ivory in such country are


1













terminated or expire; provided, that the license set forth in this Section 9.11.3.2 (To Amgen) will continue for a period of six (6) months thereafter to permit Amgen to use and distribute its inventory of labeling, packaging, package inserts and Promotional Materials (including monographs) containing GSK Housemarks in such country (or, where the on-hand inventory as of such termination or expiration of such labeling, packaging, package inserts or Promotional Materials (including monographs) cannot practically be used within such six (6) month period, such longer period as reasonably necessary to exhaust such inventory, but in no event longer than twelve (12) months), in connection with Amgen's Detailing of Ivory. Amgen will take all such steps as GSK may reasonably request to give effect to the termination of the license to the GSK Housemarks in the applicable country and to record any documents that may be required to evidence the termination of such license.” 
	
		
	4.
	The last sentence of Section 14.9.2 is amended to read in its entirety as follows:



  
“Amgen's right to use the GSK Housemarks pursuant to Section 9.11.3.2  will survive expiration or termination of the Agreement as set forth in Section 9.11.3.2.”
	
		
	5.
	The Parties agree to add Gibraltar to the list of countries set forth on the Collaboration Territory Schedule.




	
		
	6.
	All other terms, conditions and provisions of the Agreement shall remain in full force and effect except as otherwise provided herein. All references to the “Agreement” therein shall mean the Agreement as amended by this Amendment.




	
		
	7.
	This Amendment may be executed in one or more counterparts, each of which shall be deemed an original and all of which shall constitute a single instrument.




	
		
	8.
	This Amendment will be governed by, and enforced and construed in accordance with, the laws of the State of New York 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.




  


[Remainder of page intentionally left blank - signature page to follow]
2











IN WITNESS WHEREOF, the parties have caused this Amendment to be executed by their duly authorized officers or representatives.


AMGEN INC.


By: /s/ Rolf K. Hoffmann_______________


Name: Rolf K. Hoffmann


Title: Senior Vice President
International Commercial Ops




GLAXO GROUP LIMITED




By: /s/ Paul Williamson__________________


Name: Paul Williamson


Title: Corporate Director