License Agreement

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AMGEN INC | Takeda Pharmaceutical Company Limited

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Title: License Agreement
Governing Law: California Date: 5/12/2008
Industry: Biotechnology and Drugs Sector: Healthcare

License Agreement, Parties: amgen inc , takeda pharmaceutical company limited

Exhibit 10.82

Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.

License Agreement

By and Between

Amgen Inc.

and

Takeda Pharmaceutical Company Limited

Dated

February 1, 2008

CONFIDENTIAL

Table of Contents


1 DEFINITIONS		1

2 COLLABORATION SCOPE AND GOVERNANCE		9

3 GRANT OF LICENSE		13

4 DEVELOPMENT AND REGULATORY APPROVAL		17

5 COMMERCIALIZATION		23

6 LICENSEE AND AMGEN INDICATIONS; ACTIVITIES OUTSIDE THE COLLABORATION		24

7 MANUFACTURE AND SUPPLY		26

8 PAYMENT		27

9 INTELLECTUAL PROPERTY		32

10 CONFIDENTIALITY AND PUBLICATIONS		34

11 REPRESENTATIONS, WARRANTIES AND COVENANTS		38

12 LIMITATIONS OF LIABILITY; INSURANCE		40

13 INDEMNIFICATION		40

14 TERM AND TERMINATION		42

15 CHANGE OF CONTROL		43

16 MISCELLANEOUS		43

SCHEDULES

CONFIDENTIAL

License Agreement

Preamble

This License Agreement (this “Agreement” ) is entered into as of the 1st day of February, 2008 (the “Effective Date” ) by and between Amgen Inc., a Delaware corporation having its principal place of business at One Amgen Center Drive, Thousand Oaks, California 91320-1799, U.S.A. ( “Amgen” ), and Takeda Pharmaceutical Company Limited, a Japanese corporation having its principal place of business at 1-1, Doshomachi 4-chome, Chuo-ku, Osaka 540-8645, Japan ( “Licensee” ). Amgen and Licensee are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

Recitals

WHEREAS, Amgen is a global biotechnology company that conducts pharmaceutical research, development, manufacturing and commercialization;

WHEREAS, Amgen is developing a number of products for the treatment of various diseases and conditions;

WHEREAS, Amgen’s subsidiary, Amgen K.K., has previously conducted development activities in the Territory (as defined below);

WHEREAS, concurrently with the execution of this Agreement, the Parties are entering into the Sale and Purchase Agreement whereby Amgen shall sell, and Licensee shall purchase, all of the outstanding capital stock of Amgen K.K.;

WHEREAS, Licensee has existing development and commercialization capabilities in the Territory and will, subsequent to the closing of the transactions contemplated in the Sale and Purchase Agreement, have the additional development capabilities of Amgen K.K.;

WHEREAS, Amgen wishes to partner with Licensee, and Licensee wishes to partner with Amgen, in each case with respect to the development and commercialization of the Licensed Products in the Licensee Indications in the Territory (each as defined below) in accordance with the terms and conditions hereof;

NOW, THEREFORE, in consideration of the mutual promises contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the Parties hereto agree as follows:

1.	D EFINITIONS

1.1.

“Affiliate” shall mean any corporation or other entity which directly or indirectly controls, is controlled by or is under common control with a Party, for so long as such control exists. For the purposes of this Section 1.1 (“Affiliate”), “control” shall mean: (i) in the case of any corporate entity, direct or indirect ownership of more than fifty percent (50%) of the stock having the right to vote for the election of directors thereof; or (ii) in the case of any non-corporate entity, direct or indirect ownership of more than fifty percent (50%) of the equity or income interest therein.

1.2.	“Agreement” shall have the meaning set forth in the Preamble.


CONFIDENTIAL		Page 1

1.3.

“[*] Product” shall mean a [*] for which Amgen has the exclusive rights to develop and commercialize in North America, Europe and the Territory, and that is being developed for [*] and as its intended therapeutic mechanism of action targets the relevant receptor or ligand for such Distracting Product (as described on the Distracting Products Schedule).

1.4.

“[*]” or “[*]” shall mean, with respect to a commercial presentation of a Licensed Product, the unit-volume-weighted average of: (a) the [*] for the [*] presentation during the Term pursuant to the relevant [*]; (b) the [*] for such presentation where Licensee [*] such presentation [*] in accordance with this Agreement and the relevant [*]; and (c) the [*] by Licensee to [*] engaged by Licensee in accordance with this Agreement that [*] to Licensee in accordance with this Agreement and the relevant [*] is calculated without reference to any payments associated with [*]. An example of calculation of the foregoing is set forth on the Royalty Calculation Schedule.

1.5.	“Amgen” shall have the meaning set forth in the Preamble.

1.6.	“Amgen Development Costs” shall mean Amgen’s (and its Affiliates’) fully-burdened, world-wide development costs [*] related to development of a Licensed Product, as more specifically set forth in the Development Costs Schedule.

1.7.	“Amgen Development Data” shall mean the preclinical and clinical data generated by or on the behalf of Amgen or its Affiliates (both within and outside the Territory) in the course of its preclinical and clinical development of a Licensed Product, both before and after[*] of this Agreement.

1.8.	“Amgen Indemnitees” shall have the meaning set forth in Section 13.1 (Indemnity).

1.9.	“Amgen Indication” shall have the meaning set forth in Section 6.7.2 (Amgen Developed Indications).

1.10.

“Amgen K.K.” shall mean Amgen Kabushiki Kaisha, a Japanese corporation.

1.11.

“Annual Maximum” shall have the meaning set forth in Section 8.9.3 (Payment Caps).

1.12.

“Bundle” shall mean a Licensed Product sold together with another pharmaceutical compound for a single price.

1.13.

“[*]Quarter” shall mean a three-month period beginning on[*].

1.14.

“[*]Year” shall mean a one-year period beginning on [*]and ending on[*].

1.15.

“Change of Control” shall mean, with respect to Licensee, the occurrence of any of the following events: [*]

1.16.

“Claims” shall have the meaning set forth in Section 13.1 (Indemnity).

1.17.

“Collaboration” shall have the meaning set forth in Section 2.1 (Conduct of the Collaboration).

1.18.

“Commercialization Committee” shall mean the committee established by the Parties to oversee and coordinate the commercialization of a particular Licensed Product in the Territory.


CONFIDENTIAL		Page 2

1.19.

“Confidential Information” shall have the meaning set forth in Section 10.1 (Confidentiality; Exceptions).

1.20.

“Contract Interest Rate” shall mean [*]%) plus the [*] rate effective for the date [*], as published by The Wall Street Journal , Eastern U.S. Edition, on the date [*](or, if unavailable on such date, [*]on which such rate is available), or, if lower, the maximum rate permitted by Law.

1.21.

“Control” shall mean, with respect to any Information or intellectual property, that the applicable Party owns or has a license to such Information or intellectual property and has the ability to grant to the other Party access to and a license or sublicense (as applicable) under such Information or intellectual property as set forth herein without violating the terms of any agreement with any Third Party as of the time such Party would first be required hereunder to grant such access and license or sublicense, or requiring any payment (whether or not then due and payable) under any agreement with any Third Party as of the time such Party would first be required hereunder to grant such access and license or sublicense.

1.22.

“Developed [*]” shall mean a [*] having a [*] not consisting primarily of [*] that is either obtained through Licensee’s discovery research activities (whether exclusively internal or in collaboration with a Third Party) or where the rights to such [*] were controlled by a [*] at the time [*].

1.23.

“Development Committee” shall mean the committee established by the Parties to oversee and coordinate the development of a particular Licensed Product in the Territory.

1.24.

“Distracting Product” , with respect to each Licensed Product, shall have the meaning set forth on the Distracting Products Schedule.

1.25.

“Distracting Program” shall mean the [*] or [*], in the Territory, of any Distracting Product. [*].

1.26.

“Distracting Transaction” shall mean any transaction entered into by Licensee or its Affiliate after [*] whereby a Third Party that is engaged in a Distracting Program becomes an Affiliate of Licensee.

1.27.

“Distracting Transaction Affiliates” shall mean those entities that are or would become Affiliates of Licensee by virtue of a Distracting Transaction.

1.28.

“Divest” shall mean, 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, Information, 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 the relevant Party or its Affiliates.

1.29.

“Effective Date” shall have the meaning set forth in the Preamble.

1.30.

“Ex-Territory Distracting Affiliates” shall mean those entities that are or would become Affiliates of Licensee by virtue of an Ex-Territory Distracting Transaction.

1.31.

“Ex-Territory Distracting Program” shall mean any development, commercialization or manufacture of a Distracting Product intended for use or sale (or actually used or


CONFIDENTIAL		Page 3

sold) outside the Territory or intended for import (or actually imported) outside the Territory.

1.32.

“Ex-Territory Distracting Transaction” shall mean any transaction entered into by Licensee or its Affiliate after [*] whereby a Third Party that is engaged in an Ex-Territory Distracting Program becomes an Affiliate of Licensee.

1.33.

“Federal Court” shall have the meaning set forth in Section 16.11 (Jurisdiction and Venue).

1.34.

“First Commercial Sale” shall mean the first sale of a Licensed Product following Regulatory Approval by or on the behalf of Licensee, its Affiliate or sublicensees.

1.35.

“Force Majeure” shall have the meaning set forth in Section 16.8 (Force Majeure).

1.36.

“FTE” shall mean the equivalent of the work of one employee full time for one year (consisting of at least a total of [*] weeks or [*] hours per year (excluding vacations and holidays)). Overtime, and work on weekends, holidays and the like shall 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.

1.37.

“FTE Rate” shall mean [*] per full-time employee per year (as of [*]), increasing by [*]%) of the then-current FTE Rate on [*].

1.38.

“GAAP” shall mean either Japanese or U.S. generally accepted accounting principles, consistently applied, as used by a Party to record the relevant transaction.

1.39.

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

1.40.

“Indemnified Party” shall have the meaning set forth in Section 13.2 (Claim for Indemnification).

1.41.

“Indemnifying Party” shall have the meaning set forth in Section 13.2 (Claim for Indemnification).

1.42.

“Information” shall mean all tangible and intangible techniques, information, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, know-how, conclusions, skill, experience, test data and results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms.

1.43.

“Initiation” of a clinical trial or to “Initiate” a clinical trial shall mean the first dosing of a human subject with a Licensed Product in such trial.

1.44.

“Joint Patents” shall mean any invention, patent or patent application jointly owned by the Parties pursuant to Section 9.1 (Ownership).

1.45.

“Key Event” shall have the meaning set forth in Section 6.2 (Key Event Time Frames).

1.46.

“Law” shall mean, individually and collectively, any and all laws, ordinances, rules, directives, administrative circulars and regulations of any kind whatsoever of any Governmental Authority within the applicable jurisdiction.


CONFIDENTIAL		Page 4

1.47.

“Licensed Amgen Know-How” shall mean Information in Amgen’s (or its Affiliate’s) possession and Control, as of [*] or thereafter during the Term, that is reasonably necessary for Licensee to develop or commercialize a Licensed Product in the Licensee Indications in the Territory. Licensed Amgen Know-How shall include Amgen Development Data that is reasonably necessary for Licensee to develop or commercialize a Licensed Product in the Licensee Indications in the Territory. Licensed Amgen Know-How does not include Amgen manufacturing information. Licensed Amgen Know-How shall include Information known to the employees of Amgen K.K. as of the date of the consummation of the transactions contemplated in the Sale and Purchase Agreement that is reasonably necessary for Licensee to develop or commercialize a Licensed Product in the Licensee Indications in the Territory.

1.48.

“Licensed Amgen Patents” shall mean those patents and patent applications set forth on the Licensed Amgen Patents Schedule, as well as any continuation, divisional, substitution, continuations-in-part, reissue, reexamination, provisional and converted provisional application thereof, [*] For purposes of determining whether a patent application falls within this definition, a patent application shall be considered “infringed” if its pending claims would be infringed if issued as then currently set forth in the patent application.

1.49.

“Licensed Amgen Trademarks” shall mean any trademark rights Controlled by Amgen in the Territory on or after [*] and corresponding to any trademarks adopted by Amgen for use with a Licensed Product in a Licensee Indication outside the Territory (not including any corporate or house marks, and not including any such marks to the extent such marks would conflict with any right of any Third Party inside the Territory).

1.50.

“Licensed Licensee Know-How” shall mean Information in Licensee’s (or its Affiliate’s) possession and Control, as of [*] or thereafter during the Term, that is reasonably necessary for Amgen to develop, manufacture or commercialize a Licensed Product within or outside the Territory in any indication. Licensed Licensee Know-How shall include Licensee Development Data that is reasonably necessary for Amgen to develop, manufacture or commercialize a Licensed Product within or outside the Territory in any indication.

1.51.

“Licensed Licensee Patents” shall mean those patents and patent applications owned or Controlled by Licensee or its Affiliate (including an interest in a patent or Joint Patent pursuant to Section 9.1 (Ownership))[*] For purposes of determining whether a patent application falls within this definition, a patent application shall be considered “infringed” if its pending claims would be infringed if issued as then currently set forth in the patent application.

1.52.

“Licensed Licensee Trademarks” shall mean any trademarks adopted by Licensee for use with a Licensed Product in the Territory in the Licensee Indications (not including any corporate or house marks).

1.53.

“Licensed Product” shall mean any one of the pharmaceutical products listed on the Licensed Products Schedule.

1.54.

“Licensee” shall have the meaning set forth in the Preamble.


CONFIDENTIAL		Page 5

1.55.

“Licensee Assumed Item” shall have the meaning set forth in Section 9.2.1.2 (Licensee Secondary Prosecution).

1.56.

“Licensee Development Data” shall mean the preclinical and clinical data generated by or on behalf of Licensee or its Affiliates in the course of its preclinical (if any) and clinical development of a Licensed Product, on or after [*].

1.57.

“Licensee Indemnitees” shall have the meaning set forth in Section 13.1 (Indemnity).

1.58.

“Licensee Indications” shall mean with respect to each Licensed Product, the treatment, palliation, prevention or prophylaxis of disease in humans with respect only to: (i) those specific indications (e.g., third-line metastatic colorectal cancer) that, as of [*], are the subject of clinical development by Amgen or for which Amgen has received Regulatory Approval with respect to such Licensed Product outside the Territory; and (ii) any other specific indications that are added with respect to such Licensed Product pursuant to Section 6.7 (Additional Indications). For the avoidance of doubt, Licensee Indications does not include Amgen Indications.

1.59.

“Licensee Product” shall have the meaning set forth in Section 3.9 (Right of First Discussion).

1.60.

“Losses” shall have the meaning set forth in Section 13.1 (Indemnity).

1.61.

“MHLW” shall mean the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

1.62.

“Net Sales” shall mean with respect to a given period, the gross invoiced sales price for a Licensed Product sold by or on behalf of Licensee, its Affiliates or licensees hereunder to Third Parties (not including Licensee’s Affiliates, unless and to the extent such Affiliate is the end-user of such a Licensed Product) during such period (plus any additional consideration received by Licensee, its Affiliates or licensees with respect to such Licensed Product sold), less the total of the following charges or expenses, as determined in accordance with GAAP:

1.62.1.

Trade, cash, prompt payment and quantity discounts;

1.62.2.

Returns, allowances, rebates, chargebacks and payments to government agencies;

1.62.3.

Retroactive price reductions;

1.62.4.

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;

1.62.5.

Credits and allowances for product replacement, whether cash or trade; and

1.62.6.

Non-recoverable sales taxes, excise taxes, tariffs and duties (excluding taxes when assessed on income derived from sales);

in each case, to the extent related to sales of a Licensed Product in a Licensee Indication in the Territory and actually given.


CONFIDENTIAL		Page 6

1.63.

“Ongoing Studies” shall mean those clinical studies that are being undertaken by Amgen as of [*] utilizing Amgen K.K. in the Territory, including those set forth on the Ongoing Studies Schedule.

1.64.

“Party/Parties” shall have the meaning set forth in the Preamble.

1.65.

“Patent Matters” shall have the meaning set forth in Section 9.2.1.1 (Amgen Primary Prosecution).

1.66.

“Phase I Trial” shall mean, with respect to the United States, any human clinical trial, the principal purpose of which is preliminary determination of safety in healthy individuals or patients as required under 21 C.F.R. §312.21(a), or, with respect to a jurisdiction other than the United States, an equivalent clinical study.

1.67.

“Phase II Trial” shall mean, with respect to the United States, any human clinical trial conducted in the specific patient population with the disease or condition of interest intended to be studied in a Phase III Trial for the purposes of preliminary assessment of safety and efficacy in the indication being studied, and selection of the dose regimen(s) to be studied in a Phase III Trial, as described under 21 C.F.R. §312.21(b), and that, if the defined end-points are met, is sufficient to allow the Initiation of a Phase III Trial in the indication being studied, or, with respect to a jurisdiction other than the United States, an equivalent clinical study.

1.68.

“Phase III Trial” shall mean, with respect to the United States, any human clinical trial, that, if the defined end-points are met, is intended to be a pivotal trial for obtaining Regulatory Approval in the indication being studied or to otherwise establish safety and efficacy in patients with the indication being studied for purposes of filing for Regulatory Approval with the United States Food and Drug Administration (or its successor) as required under 21 C.F.R. §312.21(c), or, with respect to a jurisdiction other than the United States, an equivalent clinical study. In the event that a human clinical trial that would otherwise meet the definition of a Phase II Trial would, if the defined end-points are met, be sufficient to obtain Regulatory Approval in the indication being studied then, for the purposes of this Agreement, such trial shall be considered a Phase III Trial.

1.69.

“Pricing Approval” with respect to a Licensed Product in the Territory shall mean initial assignment, and any subsequent amendments thereto from time to time, of a Japanese National Health Insurance drug price for such Licensed Product.

1.70.

“Prior Agreement” shall have the meaning set forth in Section 10.6 (Prior Agreement).

1.71.

“[*]” shall mean: (i) with respect to a Licensed Product for which [*] outside the Territory, that Amgen, its Affiliates, and other licensees have [*] related to North America and Europe for a [*]; and (ii) with respect to a Licensed Product for which [*] outside the Territory, Amgen, its Affiliates, and other licensees have [*] such Licensed Product outside the Territory.

1.72.

“[*]” shall mean, with respect to a Licensed Product, that (i) a [*] has continued for at least [*] with respect to such Licensed Product; and (ii) Amgen, its Affiliates and licensees have not [*] such Licensed Product will be [*].


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1.73.

“Publishing Party” shall have the meaning set forth in Section 10.7.3 (Oversight and Review).

1.74.

“Quarterly Maximum” shall have the meaning set forth in Section 8.9.4 (Maximum Payments).

1.75.

“Reasonably Diligent Efforts” shall mean, with respect to Licensee and a particular Licensed Product, the application of a level of resources, efforts and urgency to develop and commercialize such Licensed Product consistent with Licensee’s practices in pursuing the development and commercialization of its other high-value pharmaceutical products in light of its characteristic features, target indication, competitiveness and sales volume, but in no event less than the high professional standards and level commonly applied by other pharmaceutical companies to their high-value pharmaceutical products. [*].

1.76.

“Recall” means a “recall” (as per Article 70 of the Japanese Pharmaceutical Affairs Law) or “market withdrawal” (as per Article 77-4-3 of the Japanese Pharmaceutical Affairs Law) of a Licensed Product or any lots thereof.

1.77.

“Recoveries” shall mean all cash amounts (plus the fair market value of all non-cash consideration) received by a Party from a Third Party in connection with the final judgment, award or settlement of any enforcement with respect to any Licensed Amgen Patent, Licensed Amgen Trademark, Licensed Amgen Know-How, Licensed Licensee Know-How, Licensed Licensee Trademark or Joint Patent, each of the foregoing with respect to Licensed Products in Licensee Indications in the Territory.

1.78.

“Regulatory Approval” shall mean the product-specific approvals from Governmental Authorities necessary for the distribution and sale of a Licensed Product.

1.79.

“Regulatory Filing” shall mean any filing with any Governmental Authority with respect to the development, marketing, commercialization or reimbursement of a Licensed Product.

1.80.

“Reviewing Party” shall have the meaning set forth in Section 10.7.3 (Oversight and Review).

1.81.

“Secondary Publication” shall have the meaning set forth in Section 10.7.1 (In Territory).

1.82.

“Sites” shall have the meaning set forth in Section 4.15 (Transition of Ongoing Studies).

1.83.

“SOPs” shall have the meaning set forth in Section 4.13 (Recalls).

1.84.

“SPC” shall mean any patent term extension or related extension of rights, including supplementary protection certificates and similar rights.

1.85.

“State Court” shall have the meaning set forth in Section 16.11 (Jurisdiction and Venue).

1.86.

“Steering Committee” shall mean the committee established by the Parties to oversee and coordinate their activities hereunder, and to ensure appropriate communication and oversight by the Parties.


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1.87.

“Sale and Purchase Agreement” shall mean that certain Sale and Purchase Agreement between the Parties dated as of the date hereof.

1.88.

“Taxes” shall mean any tax, excise or duty, other than taxes upon income.

1.89.

“Term” shall mean the period beginning on [*] and ending upon the termination of this Agreement pursuant to Article 14 (Term and Termination).

1.90.

“Termination Date” shall have the meaning set forth in Section 14.3.1 (General).

1.91.

“Territory” shall mean Japan.

1.92.

“Territory IP” shall have the meaning set forth in Section 9.4.1 (In Territory).

1.93.

“Territory Patents and Trademarks” shall have the meaning set forth in Section 9.2.1.1 ([*]).

1.94.

“Third Party” shall mean any entity other than a Party or an Affiliate of a Party.

1.95.

“Transition Period” shall have the meaning set forth in Section 14.5 (Transition Period).

1.96.

“VAT” shall mean any value added tax.

1.97.

“Vectibix” shall mean Amgen’s proprietary anti-EGFr monoclonal antibody known in the U.S. as Vectibix™ .

2.	C OLLABORATION S COPE AND G OVERNANCE

2.1.	Conduct of the Collaboration . The Parties shall cooperate to develop and commercialize the Licensed Products in the Licensee Indications in the Territory, in accordance with the terms and conditions of this Agreement (the “Collaboration” ).

2.2.

Ex-Territory Activities . The Parties acknowledge that no rights are granted hereunder to Licensee with respect to any country outside the Territory. Licensee shall not research, develop, manufacture or commercialize any Licensed Product outside the Territory without the express prior written consent of Amgen. Amgen shall have the sole right to research, develop, manufacture and commercialize the Licensed Products outside the Territory.

2.3.

Governance . The Collaboration shall be governed by a Steering Committee, which shall oversee the activities of the Parties hereunder generally, and by a Development Committee and a Commercialization Committee for each Licensed Product, which shall coordinate and oversee the development and commercialization, respectively, of Licensed Products in the Territory. The Steering Committee and each Development Committee shall be formed promptly following [*]. Each Commercialization Committee shall be formed promptly following [*] for Licensed Products which have already Initiated one or more Phase III Trials in the Territory. For all other Licensed Products, the relevant Commercialization Committee shall be formed promptly following Initiation of the first Phase III Trial in the Territory for such Licensed Product.

2.4.	Membership . Unless otherwise agreed by the Parties, each of the Development and Commercialization Committees shall be comprised of [*] members appointed by


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Amgen, and [*] members appointed by Licensee. Each such committee shall be led by [*] co-chairs, [*] appointed by each of the Parties. Unless otherwise mutually agreed by the Parties, the Steering Committee shall be comprised of [*] member appointed by Amgen and [*] member appointed by Licensee. Each of the committees shall have the right to delegate any of its responsibilities to one or more subcommittees as it determines appropriate.

2.5.

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

2.6.	Input from other Personnel . Any committee member shall have the right to solicit input or assistance from any other personnel of the Party that appointed such member.

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

2.8.	Steering Committee . The Steering Committee shall be responsible for overseeing the Parties’ conduct of the Collaboration generally, and for ensuring an appropriate level of oversight of the Collaboration.

2.8.1.

Meetings . The Steering Committee shall meet [*] in person, via teleconference or videoconference or otherwise (with at least [*] meeting per [*] Year being in person), or as otherwise agreed by the Parties. Any in-person meetings shall be held on an alternating basis between Licensee’s and Amgen’s facilities, unless otherwise agreed by the Parties. Each Party shall be responsible for its own expenses relating to such meetings. As appropriate, other employee representatives of the Parties may attend Steering Committee 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 as reasonably required to resolve particular matters requested by such Party by at least [*] days written notice to the member appointed by the other Party. All Steering Committee meetings must have the member appointed by each Party in attendance.

2.8.2.

Reporting . Each Party shall keep the Steering Committee fully and promptly informed of progress and results of activities for which it is responsible or that it is permitted to conduct hereunder through its member on the Steering Committee and as otherwise provided herein. Each Party shall fully inform the Steering Committee with respect to all relevant facts and activities regarding any Licensed Product reasonably requested by any member thereof.

2.8.3.

Decision Making . The Steering Committee shall make decisions by consensus.

2.9.

Development Committee . With respect to each Licensed Product in the Territory, the applicable Development Committee shall be responsible for: (i) reviewing and approving development plans (and changes thereto) prior to adoption of such plans (or changes) by Licensee; (ii) providing for communication and discussion between the


CONFIDENTIAL		Page 10

Parties to optimize the efficacy and safety of the development of the applicable Licensed Product in the Territory; (iii) reviewing and monitoring the activities and progress against the development plans, including site enrollment, patient enrollment, progress of trials and data received; (iv) communicating with the applicable Commercialization Committee(s) regarding the interrelationship between development activities and potential commercialization; and (v) communicating with the Parties regarding all of the foregoing.

2.9.1.

Meetings . Each Development Committee shall meet [*] in person, via teleconference or videoconference or otherwise (with at least [*] meetings per [*] Year being in person), more frequently as may be required by ongoing development activities, or as otherwise agreed by the Parties. Any in-person meetings shall be held on an alternating basis between Licensee’s and Amgen’s facilities, unless otherwise agreed by the Parties. Each Party shall be responsible for its own expenses relating to such meetings. As appropriate, other employee representatives of the Parties may attend Development Committee 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 as reasonably required to resolve particular matters requested by such Party by at least [*] days written notice to the co-chair appointed by the other Party. All committee meetings must have at least [*] member appointed by each Party in attendance.

2.9.2.

Reporting . Each Party shall keep the relevant Development Committee fully and promptly informed of progress and results of development activities for which it is responsible or that it is permitted to conduct hereunder through its members on such Development Committee and as otherwise provided herein, including by promptly providing copies of all clinical data and results for Licensed Products as reasonably requested by the other Party. Each Party shall fully inform the applicable Development Committee with respect to all relevant facts and activities regarding any Licensed Product development matter reasonably requested by any member thereof. At least [*] days prior to the first meeting of each Development Committee of each [*] Quarter, each Party shall deliver to such Development Committee a written summary of development activities conducted hereunder and material clinical data and results received by each such Party since the last such report, in each case with respect to the applicable Licensed Product(s).

2.9.3.

Development Plans . At least [*] days prior to the first meeting of each Development Committee of each [*] Year, Licensee shall provide each such Development Committee a copy of its proposed development plan for the relevant Licensed Product in the Territory for the next [*] for the Development Committee’s review, comment and approval. In addition, should Licensee seek to make material changes to an approved development plan, then at least [*] days prior to the next meeting of the relevant Development Committee it shall provide the Development Committee any proposed changes to the previously approved development plan for the Development Committee’s approval.


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2.9.4.

Decision Making . Each Development Committee shall strive to reach consensus on decisions, taking into account the views of each committee member. In the event the Development Committee fails to reach consensus, the committee [*] determination unless [*] reasonably likely to [*] on Amgen’s [*] Licensed Product [*], in which case the committee [*]determination.

2.10.

Commercialization Committee . With respect to each Licensed Product in the Territory, the applicable Commercialization Committee shall be responsible for: (i) reviewing and approving commercialization plans (and changes thereto) prior to adoption of such plans (or changes) by Licensee; (ii) communicating with the applicable Development Committee(s) regarding the interrelationship between development activities and potential commercialization; (iii) reviewing and monitoring the activities and progress against the commercialization plans; (iv) establishing appropriate processes for coordinating review of promotional materials to ensure compliance with Law and industry best practices; (v) overseeing the trademark and publication strategies; and (vi) communicating with the Parties regarding all of the foregoing.

2.10.1.

Meetings . Each Commercialization Committee shall meet [*] in person, via teleconference or videoconference or otherwise (with at least [*] meetings per [*] Year being in person), more frequently as may be required by ongoing commercialization activities, or as otherwise agreed by the Parties. Any in-person meetings shall be held on an alternating basis between Licensee’s and Amgen’s facilities, unless otherwise agreed by the Parties. Each Party shall be responsible for its own expenses relating to such meetings. As appropriate, other employee representatives of the Parties may attend Commercialization Committee 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 as reasonably required to resolve particular matters requested by such Party by at least [*] days written notice to the co-chair appointed by the other Party. All committee meetings must have at least [*] member appointed by each Party in attendance.

2.10.2.

Reporting . Each Party shall keep the relevant Commercialization Committee fully and promptly informed of progress and results of commercialization activities in the Territory for which it is responsible or that it is permitted to conduct hereunder through its members on the Commercialization Committee and as otherwise provided herein. Each Party shall fully inform the Commercialization Committee with respect to all relevant facts and activities regarding any Licensed Product commercialization matter reasonably requested by any member thereof. For each Commercialization Committee, at least [*] days prior to the first Commercialization Committee meeting of each [*] Quarter, each Party shall deliver to the Commercialization Committee a written summary of commercialization activities conducted hereunder by each such Party since the last such report.

2.10.3.

Commercialization Plans . At least [*] days prior to the first meeting of each Commercialization Committee of each [*] Year, Licensee shall provide each such Commercialization Committee a copy of its proposed commercialization


CONFIDENTIAL		Page 12

plan for the relevant Licensed Product in the Territory for the next [*] for the Commercialization Committee’s review, comment and approval (either by indication or for all indications for which it is responsible in the Territory). In addition, should Licensee seek to make material changes to an approved commercialization plan, then at least [*] days prior to the next meeting of the relevant Commercialization Committee it shall provide the Commercialization Committee any proposed changes to the previously approved commercialization plan for the Commercialization Committee’s approval.

2.10.4.

Decision Making . Each Commercialization Committee shall strive to reach consensus on decisions, taking into account the views of each committee member. In the event a committee fails to reach consensus, the committee [*] determination unless [*] reasonably likely to [*] on Amgen’s [*] of the applicable Licensed Product [*], in which case the committee [*] determination.

2.10.5.

Right to Terminate Participation . Amgen shall have the right to terminate its participation in any or all of the committees contemplated pursuant to this Article 2 (Collaboration Scope and Governance) by [*] days prior written notice to Licensee. In the event of such termination, matters subject to the collaboration and oversight of the relevant Committees shall be dealt with directly between Amgen and Licensee. All information that was to be provided by a Party to a committee that has been terminated shall instead provide such information (in the same time frames as previously required) directly to the other Party. With respect to any matter under the purview of the terminated Committee(s) that was subject to a final determination by Amgen’s or Licensee’s committee members, such matter shall instead be subject to the final determination of Amgen or Licensee, respectively.

3.	G RANT OF L ICENSE

3.1.

Licensed Amgen Patents . Amgen hereby grants Licensee an exclusive right and license under the Licensed Amgen Patents during the Term, subject to the terms and conditions hereof, solely to develop, commercialize, use and sell Licensed Products only in the Licensee Indications in the Territory. Such license (and such exclusivity) is only with respect to the Licensed Products in the Licensee Indications in the Territory. Such license shall include the right to sublicense only as set forth in Section 3.5 (Licensee Sublicensing).

3.2.

Licensed Amgen Know-How . Amgen hereby grants Licensee an exclusive right and license during the Term, subject to the terms and conditions hereof, to utilize the Licensed Amgen Know-How solely for the purpose of supporting its development, commercialization, use and sale of Licensed Products only in the Licensee Indications in the Territory. Such license (and such exclusivity) is only with respect to the Licensed Products in the Licensee Indications in the Territory. Such license shall include the right to sublicense only as set forth in Section 3.5 (Licensee Sublicensing).

3.3.	[]. In addition to the rights granted to Licensee pursuant to Sections 3.1 (Licensed Amgen Patents) and 3.2 (Licensed Amgen Know-How), Amgen hereby grants Licensee [] during the Term under certain [*], subject to the terms and conditions hereof, solely


CONFIDENTIAL		Page 13

to develop, commercialize, use and sell Licensed Products only in the Licensee Indications in the Territory. The [*] with respect to each Licensed Product are detailed on the [*] and shall be subject to the restrictions and conditions set forth therein. Such [*] shall include the right to [*] only as set forth in [*], and further subject to the restrictions and conditions set forth on [*]. Specific [*] with respect to the [*] are set forth on the [*]. Licensee (and any of its permitted sublicensees) shall comply with all such obligations. In addition, Licensee shall take any other reasonable steps requested by Amgen to ensure compliance with the [*] (including providing [*]. At Amgen’s request, Licensee shall cooperate with Amgen to secure for Licensee some or all [*] from the [*] (including by [*]), provided, however, that Licensee shall not be required to [*] than those set forth on [*]. At such time as Licensee has [*] with respect to any [*] hereunder, the [*] pursuant to this Agreement [*].

3.4.

Licensed Licensee Know-How and Patents . Licensee hereby grants Amgen [*] right and license, subject to the terms and conditions hereof, under the Licensed Licensee Know-How and Licensed Licensee Patents solely for the purpose of the development, commercialization, manufacture, use and sale of Licensed Products outside the Territory (and within the Territory, in any Amgen Indications) for all uses, and inside and outside the Territory, for performing its obligations hereunder, including any supply obligations with respect to Licensed Products. Such license shall include the right to sublicense [*] provided, however, that: (i) any sublicensee shall be required to enter into a written agreement obligating it to maintain the confidentiality of the Confidential Information of Licensee; (ii) Amgen shall be responsible for any disclosure of the Confidential Information of Licensee by such sublicensee in violation of the provisions of Article 10 (Confidentiality and Publications); (iii) no such sublicense shall operate to excuse Amgen’s compliance with its obligations hereunder; and (iv) Amgen shall be responsible for a breach by such sublicensee of any such obligations or prohibitions.

3.5.

Licensee Sublicensing . Licensee shall have the right to sublicense the rights granted it hereunder only with Amgen’s prior written consent, which Amgen may withhold or condition in its sole discretion. Any permitted sublicensee shall be required to enter into a written agreement obligating it to maintain the confidentiality of the Confidential Information of Amgen and Licensee shall be responsible for any disclosure of the Confidential Information of Amgen by such sublicensee in violation of the provisions of Article 10 (Confidentiality and Publications). In addition, such written agreement shall require such sublicensee to comply with the obligations and prohibitions of this Agreement relevant to the right(s) sublicensed, and Licensee shall be responsible for a breach by such sublicensee of any such obligations or prohibitions. No sublicense shall operate to excuse Licensee’s compliance with its obligations hereunder. Licensee shall have the right to distribute a Licensed Product in the Territory through reputable distributors.

3.6.

Provision of Know-How . Following [*], the Parties shall cooperate to establish procedures for the provision of Licensed Amgen Know-How to Licensee and Licensed Licensee Know-How to Amgen. During the Term, Amgen shall use reasonable efforts to provide all material Licensed Amgen Know-How to Licensee, and Licensee shall use reasonable efforts to provide all material Licensed Licensee Know-How to Amgen. In any event, each of the Parties shall provide to the other any Licensed Amgen Know-


CONFIDENTIAL		Page 14

How or Licensed Licensee Know-How (respectively) as the other Party shall reasonably request. Notwithstanding the foregoing, Amgen shall have no obligation to provide manufacturing information to Licensee and neither Party shall have an obligation to provide information relating to any product other than the Licensed Products.

3.7.	Trademarks .

3.7.1.

Grant to Licensee . Amgen hereby grants Licensee [*] (except as otherwise expressly set forth herein (such exception to include Amgen’s co-promotion rights pursuant to Section 5.2 (Amgen Co-Promotion Right) and the transition period described in Section 14.5 (Transition Period))) right and license during the Term, subject to the terms and conditions hereof, solely to develop, commercialize, use and sell a Licensed Product in the Territory in the Licensee Indications under the same Licensed Amgen Trademarks as used by Amgen for such Licensed Product in the corresponding indications outside the Territory. Such license shall include the right to sublicense only as set forth in Section 3.5 (Licensee Sublicensing). The Parties acknowledge that the use of the Licensed Amgen Trademarks in the Territory may have commercial value to Licensee, and that Licensee shall have the right to commercialize a Licensed Product in the Licensee Indications in the Territory under the same Licensed Amgen Trademarks as utilized for such Licensed Product in such indications by Amgen outside the Territory. Should the Parties desire that a different trademark be used for Licensee Indications in the Territory, or if additional trademarks to those used outside the Territory are otherwise required, the Parties shall consult and agree upon an additional or replacement trademark (or trademarks). In addition, if the manufacture of Licensed Product for Licensee for use in the Territory materially varies from the manufacture of Licensed Product for Amgen or its Affiliates for use outside the Territory, then upon request of Amgen the Parties shall consult and agree upon a replacement trademark (or trademarks). Upon Amgen’s request, Licensee shall include an Amgen trademark designated by Amgen to Licensee in writing (e.g., “Amgen”) on all packaging, labeling, promotional and marketing materials for the applicable Licensed Product in equal prominence to those of Licensee. Amgen hereby grants Licensee a non-exclusive right and license, with the right to sublicense only as set forth in Section 3.5 (Licensee Sublicensing), during the Term, subject to the terms and conditions hereof, to use such marks solely for such purpose.

3.7.2.

Grant to Amgen . Licensee hereby grants Amgen [*] right and license during the Term to use Licensed Licensee Trademarks in connection with Amgen’s activities pursuant to Section 5.2 (Amgen Co-Promotion Right). Upon any termination or expiration of this Agreement (in its entirety or with respect to a particular Licensed Product in accordance with Section 14.2.3 (Specific Product Termination)), such license shall become perpetual, and shall include the right to use the relevant Licensed Licensee Trademarks (and the associated goodwill) in connection with the relevant Licensed Product(s) in all indications and both within and outside the Territory or, at Licensee’s option, Licensee shall have the right to assign at no charge to Amgen the relevant Licensed Licensee Trademarks (and the associated goodwill).


CONFIDENTIAL		Page 15

3.8.

Trademark Quality Standards . Each Party shall (i) maintain such reasonable quality standards for the Licensed Amgen Trademarks (with respect to Licensee) or the Licensed Licensee Trademarks (with respect to Amgen) as it maintains for its own trademarks of a similar nature and shall comply with the other Party’s reasonable specifications and usage standards supplied to it in writing (and as may be updated by written notice from time to time); (ii) not use any Licensed Amgen Trademark (with respect to Licensee) or Licensed Licensee Trademark (with respect to Amgen) in a manner that suggests any connection with any product other than a Licensed Product or any service; and (iii) not use or display the Licensed Amgen Trademarks (with respect to Licensee) or the Licensed Licensee Trademarks (with respect to Amgen) in any manner that might dilute, tarnish, disparage or reflect adversely on the other Party or such marks. Prior to using any Licensed Amgen Trademark (with respect to Licensee) or Licensed Licensee Trademark (with respect to Amgen), the Parties shall agree upon a guideline for use of such trademarks, including the review procedure and timing. From time to time, upon request by a Party, the other Party shall provide copies of the usage of the Licensed Amgen Trademarks (with respect to Licensee) or Licensed Licensee Trademarks (with respect to Amgen) used in the marketing or promotion of a Licensed Product in order to review such usage. Amgen agrees that it shall not seek to register or obtain ownership rights in any Licensed Licensee Trademark (or confusingly similar trademark) and Licensee agrees that it shall not seek to register or obtain ownership rights in any Licensed Amgen Trademark or any trademark used by Amgen in connection with a Licensed Product outside the Territory in any indication (or confusingly similar trademark to any of the foregoing).

3.9.

Right of First Discussion . Licensee agrees that Amgen shall have a right of first discussion with respect to any Distracting Product contemplated to be outlicensed by Licensee or its Affiliate, or rights to which are contemplated to be sold or transferred to a Third Party, or for which Licensee or its Affiliate seeks a development and/or commercialization collaborator (a “Licensee Product” ) for North America or Europe (or any portion thereof). Should Licensee determine to seek a licensee or collaborator in such territory for a Licensee Product, it shall give prompt written notice to Amgen thereof, and shall provide Amgen any information reasonably requested by Amgen to allow Amgen to determine its potential interest in such Licensee Product. Should Amgen, within [*] days of receipt of such notice and information, notify Licensee in writing that Amgen is interested in pursuing a potential license or collaboration, then Licensee and Amgen shall discuss such a potential transaction in good faith, and Licensee shall not discuss a potential license or collaboration with respect to such Licensee Product with any Third Party until at least [*] days after initiation of such good-faith discussions. No such license or collaboration shall be effective or binding on either Party unless and until set forth in a definitive written agreement duly executed by the Parties.

3.10.

Retained Rights and Limitations . No rights are granted to Licensee hereunder to Licensed Amgen Patents, Licensed Amgen Know-How or Licensed Amgen Trademarks outside the Licensee Indications, or outside the Territory. No rights are granted to Licensee hereunder to make or have made a Licensed Product or any other product. No rights are granted to Licensee hereunder to import or export a Licensed Product


CONFIDENTIAL		Page 16

manufactured by Amgen or its licensee. No rights are granted herein to Licensee to control the research, development or commercialization of a Licensed Product outside the Territory. No rights to either Party’s patents, trademarks or other proprietary rights are granted pursuant to this Agreement except as expressly set forth herein, and all other rights are reserved.

3.11.

[*]. Amgen shall have the right to [*] to the Collaboration as [*] by written notice to Licensee, such notice to be given within [*]. As of the date of such notice, [*] shall be considered [*] hereunder for all purposes. Promptly following such [*], Licensee shall [*] Amgen any [*] that would have been required hereunder [*] as a [*] (including pursuant to [*] and shall reimburse to Amgen any reasonable costs incurred by Amgen with respect to [*] in the Territory subsequent to [*] (including costs of [*] in the Territory). In the event Amgen does not so [*] within the [*], then Amgen shall [*]of the [*] Licensee pursuant to Section [*]. Any such [*] shall be [*] within [*] days of the end of such [*] period.

4.	D EVELOPMENT AND R EGULATORY A PPROVAL

4.1.

Responsibility for Development in Licensee Indications . Licensee shall use its Reasonably Diligent Efforts to develop each Licensed Product in each Licensee Indication in the Territory. Such development shall be conducted in accordance with the then-current development plan approved by the Development Committee for such Licensed Product in such Licensee Indication. Licensee’s responsibility with respect to Licensed Products in Licensee Indications in the Territory shall include: (a) filing for and seeking Regulatory Approval for Licensed Products in the Territory for a particular Licensee Indication in the name of Licensee from the relevant Governmental Authorities; (b) identifying and carrying out all major development tasks to be conducted prior to submission of filings for Regulatory Approval of a Licensed Product in the Territory for a particular Licensee Indication and any post-approval activities to be conducted for any such Licensed Product in such Licensee Indication; (c) identifying key development objectives, expected associated resources, risk factors, timelines, decision points and relevant decision criteria; (d) carrying out all aspects of all clinical trials necessary to obtain Regulatory Approval in the name of Licensee in the Territory for each Licensed Product in each Licensee Indication (including post-approval clinical studies) including, but not limited to, (i) designing study protocols; (ii) establishing/contracting with clinical trial sites, investigators and clinical research organizations, (iii) enrolling clinical trial subjects, (iv) organizing investigator meetings, scientific meetings, advisory panel workshops and regulatory meetings, and (v) analyzing and summarizing clinical trial results; (e) performing any other additional clinical research in support of the clinical development of each Licensed Product; (f) forecasting clinical manufacturing production requirements; and (g) reporting on study design, study outcome, other communications and regulatory filings to the appropriate Governmental Authority. Licensee shall be solely responsible for its costs incurred in its development of the Licensed Products.

4.2.	Preclinical Development in Licensee Indications . Amgen shall have the first option to perform (itself or through a subcontractor) any preclinical research that is required in order to conduct development of a Licensed Product in one or more Licensee


CONFIDENTIAL		Page 17

Indications in the Territory in accordance with this Agreement. Licensee shall give Amgen prompt written notice upon becoming aware of any such requirement. Amgen shall, promptly following receipt of such notice, notify Licensee of whether or not Amgen intends to conduct such research or, instead, shall permit Licensee to do so. Should Amgen not elect to perform such research, then Licensee shall promptly and diligently conduct such research (itself or through a subcontractor). [*] Such research shall be conducted in accordance with a research plan to be agreed in writing by Amgen and Licensee. Notwithstanding the foregoing, should [*] is reasonably likely to [*] of a Licensed Product [*] then it shall notify [*] In such case,[*] Upon the request of either Party, the Parties shall [*] of such research.

4.3.

[*] Should Licensee determine to [*] of such Licensed Product for the [*] (including with respect to [*] (e.g., [*] and including [*] Licensee shall give Amgen prompt prior written notice thereof. The Parties shall promptly meet to discuss [*]. Should Amgen agree in writing to permit the [*], the Parties shall agree on a course of action with respect to such [*] prior to undertaking any such [*] and Licensee shall conduct such [*] in accordance with any [*] by Amgen to [*] to Amgen’s [*]. Should Amgen not so agree, then Licensee shall not [*]. Upon the request of either Party, the Parties shall meet to discuss [*]

4.4.	Development in Combination . Licensee shall not, without Amgen’s prior express written consent, conduct any development of a Licensed Product in combination with any other pharmaceutical product, unless and only to the extent that Amgen is pursuing such development outside the Territory.

4.5.

Development in Amgen Indications and Outside the Territory . Amgen shall have the sole right to manage and conduct the development of the Licensed Products inside the Territory in any Amgen Indications and outside the Territory in all indications. The foregoing is without prejudice to Licensee’s payment obligations pursuant to Section 8.9 (Development Cost Sharing).

4.6.

Global Development . The Parties acknowledge that it may be in their mutual interests to integrate Licensee’s development of a Licensed Product within the Territory into Amgen’s global development plan for such Licensed Product for a particular Licensee Indication. The Parties agree to discuss in good faith where it may be appropriate to so integrate such development, and the relevant cost-sharing that will be applicable thereto. The Parties further acknowledge the mutual desire to progress Licensed Products in an effort to provide meaningful therapies to patients. While each Party acknowledges that the Licensed Products are of a developmental nature and that there is no guarantee that any or all Licensed Products will ultimately provide such benefits, the Parties express their current desire to seek to progress the Licensed Products as is reasonably prudent, in accordance with this Agreement, to provide data that can inform the Parties of the development potential of the Licensed Products.

4.7.

Sharing of Regulatory Filings . Licensee will disclose to Amgen a draft copy of any Regulatory Filing in the Territory (and any regulatory filing relating to manufacturing made by Licensee in accordance with Section 7.4 (Responsibility for Regulatory Filings with Respect to Manufacturing)) no less than [*] days prior to filing it with a Governmental Authority. Licensee will consider in good faith any comments made by


CONFIDENTIAL		Page 18

Amgen with respect to such filings. Where documents are not in English, Licensee shall also provide an English summary. Licensee shall maintain a database which contains all clinical trial data accumulated from all clinical trials of a Licensed Product conducted by, on behalf of, or with the support of Licensee in the Territory (in a computer readable format as reasonably specified by Amgen). Upon the request of either Party, the other Party shall provide a right of reference to any requested Regulatory Filings (and any regulatory filing relating to manufacturing made by Licensee in accordance with Section 7.4 (Responsibility for Regulatory Filings with Respect to Manufacturing)) or Regulatory Approvals for a Licensed Product in the Territory, and Amgen shall provide the same such right of reference to Licensee with respect to such Regulatory Filings and Regulatory Approvals outside the Territory, in each case as reasonably necessary for the requesting Party’s development or commercialization of such Licensed Product as permitted hereunder (or, with respect to Amgen, manufacture of such Licensed Product). Notwithstanding the foregoing, Amgen shall not be required to provide to Licensee nor to allow Licensee to access (but shall provide a right of reference as set forth in Section 4.12.3 (Amgen Cooperation – Manufacturing Information) to the extent necessary) Amgen’s manufacturing information with respect to a Licensed Product or any sections of any Regulatory Filing related thereto and neither Party shall have an obligation to provide information relating to any product other than a Licensed Product.

4.8.	Quality Agreement . Promptly following [*], the quality assurance departments of Amgen and L

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