11.3

11.4

11.5

11.6

11.7

11.8

11.9

Confidentiality and Non-Use

12.1

12.2

12.3

12.4

12.5

12.6

12.7

Publications

13.1

13.2

Celltech and Amgen are biopharmaceutical companies with an ongoing interest in the research, development, manufacture and commercialisation of pharmaceutical products for the treatment of human diseases.

Celltech and/or its Affiliates have developed certain intellectual property rights, technology, know-how and expertise which relate to BEER, the modulation of which may be useful in the treatment of the Osteoporosis Indication and Other Indications (all terms used in these recitals as defined in Article 1), and which may be useful in Developing and exploiting of BEER technology and know-how and Antibody Products.

Amgen has reviewed and evaluated the technology, know-how and intellectual property rights relating to Celltech’s BEER programme supplied by Celltech under terms of confidentiality and limited use and Amgen now wishes to collaborate with Celltech regarding using BEER technology, intellectual property rights and know-how in the further Research, Development and Commercialisation of Antibody Products.

Amgen and/or its Affiliates have certain technology, know-how and expertise which may be useful in Developing and exploiting of BEER technology and know-how and Antibody Products, and Celltech now wishes to collaborate with Amgen regarding using BEER technology and know-how in the further Research, Development and Commercialisation of Antibody Products.

The Parties believe it to be in their mutual interest and in the interest of the public to grant each other such intellectual property licences and other rights as are necessary to continue the research and development begun by Celltech so as to Commercialise Antibody Products resulting from the aforesaid Research and Development.

Exclusive Collaboration.   The Parties agree to collaborate exclusively in the Research, Development and Commercialisation of Antibody Products in the Field in accordance with the terms of this Agreement and, other than as explicitly permitted under this Agreement, not to undertake or enable any Third Party to undertake any activities for Antibody Products without the other Party’s prior written consent (which may be withheld for any reason), including to undertake or enable any Third Party to undertake any activities for Antibody Products for any use outside of the Field (including [*]).

Provision of Assistance.   Each Party shall co-operate reasonably with the other Party to facilitate the Research, Development and Commercialisation of Antibody Products in the Field. In addition to other assistance explicitly set forth in this Agreement, during the Term Amgen shall provide Celltech with reasonable technical assistance relating to the use of [*] Know-How, [*] Know-How and [*] Know-How and Celltech shall provide Amgen with reasonable technical assistance relating to the use of [*] Know-How, [*] Know-How and [*] Know-How, each solely to the extent licensed to the other Party in this Agreement. In addition, during the Term each Party shall make its employees, consultants and agents reasonably available upon reasonable notice during normal business hours at their respective places of employment to consult with the other Party on issues relating to this Agreement or any request from any Regulatory Authority concerning an Antibody Product, including requests relating to regulatory, scientific and technical issues. Each Party shall also keep the Joint Research Committee, Joint Development Committee, Joint Commercialisation Committee and Collaboration Committee, as appropriate, informed as to its progress in the Research, Development and Commercialisation of Antibody Products. A Party shall not be in breach of any obligation under this Agreement to the extent its inability to perform such obligation is caused by the other Party’s failure to perform any of its obligations under this Agreement.

Decision Making and Obligations.   Control of a final decision-making authority for any aspect of the Research, Development and/or Commercialisation as set forth in this Agreement shall not relieve the Party with such control from any of its obligations under this Agreement.

Transfer of Materials.   The Parties anticipate that each Party may transfer certain of its Materials to the other Party. Each Party agrees that it will use such Materials of the other Party only in accordance with the terms and conditions of, and solely for the purposes of the activities conducted pursuant to, this Agreement, and will not transfer such Materials of the other Party to any Third Party without the consent of the other Party, except as expressly permitted under this Agreement.

Third Party Research Agreements.   The Parties shall, through the Collaboration Committee or its designees, agree upon and co-ordinate Material transfer agreements and collaboration agreements with Third Parties (excluding Third Party subcontractors) to the extent such agreements relate to the Research or Development of Antibody Products or BEER or involve the use of Antibody Products or BEER, in a manner so as to conserve the available quantities of the Parties’ Materials and to avoid compromise of the Parties’ abilities to fulfil their obligations and responsibilities under this Agreement, and with a view toward maintaining access to relevant intellectual property rights. Notwithstanding the above, other than with respect to Antibody Products, neither Party may transfer the other Party’s Materials to any such Third Parties, without the express written consent of the other Party.

Employee Obligations.   Prior to beginning work relating to any aspect of the subject matter of this Agreement and/or being given access to the [*] Technology or [*] Technology, each employee, consultant or agent of Celltech and Amgen shall be bound by an employment agreement or other agreement pursuant to which (a) each such person (other than administrative and/or non-technical personnel) shall (but in the case of a Party’s own Technology, only to the extent such Party’s employees consultants or agents are conducting activities pursuant to this Agreement) be obliged to comply with all of the obligations of Celltech or Amgen under this Agreement, as appropriate, including:

(i) following Celltech’s or Amgen’s (as appropriate) policies and procedures regarding reporting any invention, discovery, process, software program or other intellectual property right created by such person in the course of his or her employment or retainer with Celltech or Amgen, as appropriate, within [*] Technology or [*] Technology; (ii) assigning to Celltech or Amgen, as appropriate, all of his or her right, title and interest in and to any such invention, discovery, process, software program or other intellectual property right; (iii) co-operating in the preparation, filing, prosecution, maintenance and enforcement of any Patent Rights covering the same; and (iv) performing all acts and signing, executing, acknowledging and delivering any and all papers, documents and instruments required for effecting the obligations and purposes of this Agreement and (b) each person shall be bound by obligations of confidentiality and non-use consistent with the terms of this Agreement. It is understood and agreed that any such agreement need not be specific to this Agreement.

No Parking.   Each Party acknowledges that using Commercially Reasonable Efforts requires it to take ongoing actions that are consistent with a good faith intention to achieve the objective of Developing an Antibody Product and obtaining Regulatory Approvals to Commercialise such Antibody Product for the [*] (or if the [*] is dropped in accordance with the terms of this Agreement an [*] chosen in accordance with the terms of this Agreement) in the Field, and to Commercialise such Antibody Product, throughout the Amgen Territory and Celltech Territory. For the avoidance of doubt, Development and Commercialisation in each instance includes the manufacture and the supply of Antibody Product. If a Party decides that deployment of Commercially Reasonable Efforts does not justify it making continued, ongoing efforts towards this objective it shall promptly notify the other Party in writing.

Collaboration Regarding Research and Development.

From and after the Effective Date:

the Parties shall use diligent and timely efforts to satisfactorily complete Research of the Antibody Products and obtain in one of the [*] for an Antibody Product an IND in the [*] or, if agreed by the Joint Research Committee pursuant to Article 3.7.1(e), an [*];

In addition to its Development supply obligations as set out in Article 6, Celltech shall use Commercially Reasonable Efforts:

to satisfactorily complete, in respect of an Antibody Product, those Development activities assigned to it pursuant to Article 3.2.2(b) and Article 3.2.2(c); and

following delivery by Amgen to Celltech of a filed data package pursuant to Article 4.1(d), to obtain Regulatory Approval to Commercialise an Antibody Product supported by, in the indication supported by, such data package, in the Field throughout the Celltech Territory.

Amgen shall:

use Commercially Reasonable Efforts to satisfactorily complete all Development activities with respect to an Antibody Product (other than those Development activities assigned to Celltech pursuant to Article 3.2.2(b) and Article 3.2.2(c)); and

use Commercially Reasonable Efforts to obtain Regulatory Approval to Commercialise an Antibody Product;

Each Party acknowledges that the obligations it undertakes pursuant to this Article 3.1.1 are material obligations.

Each Party agrees to conduct its Research activities and Development activities in compliance with all laws, regulations and guidelines that are applicable to the particular stage of Research or Development for the Antibody Product, including, GLP, GCP and GMP, of the relevant jurisdiction as the same may be amended from time to time.

Neither Party will approve, oppose or take any action under this Agreement which is contrary to its preliminary or final conclusions that the safety or toxicity of an Antibody Product then being considered for Development or being Developed pursuant to this Agreement would pose a [*] that is [*] to patients.

Notwithstanding any other term of this Agreement, [*] shall not, except with the written consent of [*], have an Antibody Product in Late Stage Development in more than one [*] unless (i) Regulatory Approval for the Commercialisation of an Antibody Product has been obtained in any of the [*] or (ii) such additional [*] was included in the first [*] for such Antibody Product presented to [*] pursuant to Article [*].

Activities.   Without limiting the obligations of Article 3.1 the Parties shall undertake the Research and Development activities as follows:

Research

The Parties shall conduct all activities for the Research of Antibody Products in accordance with the Research Plan, a copy of which is attached as Schedule A, as may be amended from time to time by the Joint Research Committee, with the Research objective of filing an IND and initiating clinical studies for at least one Antibody Product.

As part of the Research, Celltech shall use diligent and timely efforts to:

supply Amgen with [*] Antibody in amounts in line with the Research Plan as of the Effective Date and such additional amounts as may be reasonably requested by Amgen (which request will recognize timing constraints for supply imposed by Celltech’s existing capacity to provide), and in each case to specifications and timing agreed by the Joint Research Committee, for use by Amgen in [*] studies;

supply Amgen with such quantities of [*] as requested by Amgen and as Celltech shall have the existing capacity to provide, and to specifications and timing agreed by the Joint Research Committee, for use by Amgen in [*] studies; and

provide Amgen with any Information [*] which [*] reasonably considers to be [*] to the [*] safety and/or toxicity of Antibody Products (being considered for Development or being Developed).

As part of the Research, Amgen shall use diligent and timely efforts to:

conduct [*] studies required to select an Antibody Product clinical candidate and file an IND therefor in one of the [*]. For the avoidance of doubt, nothing in this Agreement shall preclude Amgen from filing INDs in such other countries as it sees fit;

conduct studies to identify, test and select [*] and, if applicable, [*] for use in the Development of Antibody Products; and

provide [*] with any [*] arising from the studies referred to in (i) and (ii), and with any [*] which [*] reasonably considers to be [*] to the [*] safety and/or toxicity of Antibody Products (being considered for Development or being Developed).

If (i) Celltech has not achieved Milestone 1 as set out in Schedule A by the [*] of the [*]; or (ii) if Celltech achieves [*] but subsequently fails to achieve Milestone 3 as set out in Schedule A within [*] of Amgen notifying Celltech in writing (pursuant to Article 3.2.1(g) below) of [*] Antibody as determined by the [*] study results; the Parties (upon the written request of [*]) shall for a period of [*] of [*] with respect to unachieved Milestone 1 or unachieved Milestone 3 (as applicable) discuss the possibility of extending such time period for an additional, mutually agreed period. Each Party acknowledges that it shall be [*] as to whether or not to agree to such an extension of any such time period.

Within [*] of expiry of each date referred to in Article 3.2.1(d) or any extension to such dates agreed to by the Parties, Amgen shall notify Celltech in writing that Amgen will either:

assume the right and obligation to Research, Develop, and supply either itself or through agreement with a Third Party the [*] referred to in Milestone 1 and/or (as appropriate) the [*] referred to above in Article 3.2.1(d); or

terminate this Agreement.

Where Amgen has exercised the option set out in Article 3.2.1(e)(i) the following shall apply and this Agreement shall be deemed to be amended as follows:

all Research and Development Costs incurred by either Party after the exercise of such option shall be shared equally by the Parties;

Amgen shall have no obligation to pay any Milestone Payments pursuant to Article 7.2 not already paid or due to be paid at the time that Amgen exercises such option;

Amgen shall cease to have any rights to use or exploit any of the [*] Patent Rights and any other [*] Technology that [*] to any invention claimed by any of the [*] Patent Rights, and Celltech shall cease to have any obligation to provide Amgen with any Information concerning the [*] Patent Rights, or to provide Amgen with assistance or guidance in using or understanding the [*] Technology covered by the same, but without prejudice to the rights [*] has to other [*] Technology as granted hereunder;

Celltech’s obligations to conduct Research activities shall terminate save for those under Articles 3.2.1(b)(ii) and (iii) and its obligations with respect to the manufacture and supply of Antibody Raw Material (including those pursuant to Articles 3.2.2(c) and Article 6) shall terminate and Amgen shall assume all such responsibilities; and

Amgen’s Research obligations shall, for a period not to exceed [*] from the date Amgen exercised the option pursuant to Article 3.2.1(e), be amended by the substitution of “Commercially Reasonable Efforts” for “diligent and timely efforts” wherever it appears. Celltech shall provide Amgen with reasonable co-operation in connection with its Research activities. If Amgen has not commenced [*] on an Antibody Product clinical candidate within [*] of exercise of the option referred to in Article 3.2.1(e)(i), this Agreement shall terminate automatically and without notice. If Amgen has commenced such [*] before such date, from the commencement of such [*] Amgen shall again be obliged to use diligent

and timely efforts where it was previously obliged to use diligent and timely efforts. Save for the change in the level of effort required by Amgen during such period, Amgen’s Research and Development obligations as set out in this Agreement shall continue to apply;

Amgen shall provide the Joint Research Committee with the results of the [*] studies conducted as set out in the Research Plan, within [*] of completion of those studies. The Joint Research Committee shall determine the characteristics required of the [*] for Milestone 3 within [*] of its receipt of the results of the [*] studies and Amgen shall promptly notify Celltech in writing of such characteristics. Should the Joint Research Committee subsequently decide to change such characteristics, Amgen shall notify Celltech of such change within [*] of the Joint Research Committee decision and the [*] referred to in Article 3.2.1(d) (with respect to the achievement of Milestone 3) shall commence on the date of Celltech’s receipt of such subsequent notice.

Development

Other than as specifically set forth in this Article 3.2.2 and Article 6, Amgen shall be responsible for all activities of Development of Antibody Products, and shall have the right to make all strategic and tactical decisions with respect to the Development of Antibody Products subject always to its obligations under this Agreement. Amgen shall be responsible for all Development tasks (other than those which Celltech undertakes pursuant to Article 3.2.2(b) or Celltech is responsible for pursuant to Article 3.2.2(c) and Article 6, below), including:

determining in which [*] to conduct clinical studies provided that Amgen may not select an [*] in substitution of the [*] except in accordance with Article 3.2.2(e);

submitting all necessary Regulatory Filings for initiation of clinical studies;

identifying key Development objectives, expected associated resources, risk factors, timelines, Go/No Go decision points and relevant decision criteria;

forecasting clinical manufacturing production requirements;

carrying out all aspects of (e.g., designing studies and protocols for and conducting) clinical studies (but excluding [*]), as well as establishing new dosage forms, new formulations or other enhancements of approved Antibody Products including (1) establishing/contracting with clinical sites, investigators and CROs; (2) enrolling clinical study patients; (3) organising investigator meetings, scientific meetings, advisory panel workshops and regulatory meetings; and (4) analysing, summarising clinical study results;

performing any other additional pre-clinical research in support of the clinical development of Antibody Products;

subject to Article 4, reporting to Regulatory Authorities on study design, study outcome, other regulatory communications and filings; and

maintaining a database of clinical trial data accumulated from clinical studies of all Antibody Products, all safety data, and any adverse reaction information acquired for all Antibody Products during Development or Commercialisation.

With respect to any Antibody Product and indication which is in [*], Celltech may undertake supplemental [*] activities for that indication in the Celltech Territory where it reasonably considers that such studies are [*] in order to obtain any Regulatory Approvals within the Celltech Territory. Such studies shall be carried out in a manner consistent with the objectives of [*] for that indication as determined by the Joint Development Committee (which objectives shall recognise Celltech’s right to conduct such studies).

Celltech shall be responsible for providing Amgen with guidance and Information Controlled by Celltech and obtained from Celltech’s experience in the development of [*], including pre-clinical and clinical safety data and other information Controlled by Celltech, in each case to the extent Celltech in good faith considers the same to be [*] to the Development of Antibody Products.

Each Party shall conduct its Development responsibilities regarding Antibody Product(s) pursuant to this Article 3.2.2 in a manner consistent with its obligations under Article 3.1.

Should Amgen reasonably determine that it no longer wishes to continue to pursue Research or Development activities of an Antibody Product for the [*] and that it wishes instead to Develop Antibody Product for an [*] it shall promptly notify the Joint Research Committee (if the Antibody Product is still the subject of Research activities); or the Joint Development Committee if the Antibody Product has ceased to be in Research and is the subject of Development activities. Such notice shall set out Amgen’s reasons in detail, and include reasonable supporting evidence. If Celltech disputes that the [*] should be dropped, or disputes the choice of an [*] and suggests a different [*] it shall notify the relevant Committee in writing setting out its reasons in detail, and including reasonable supporting evidence. If the Joint Research Committee or Joint Development Committee (as appropriate) cannot agree (and [*] has [*]) the decision as to whether the [*] should be dropped and an [*] substituted in its

place shall be escalated for consideration by the Collaboration Committee. Within the Collaboration Committee, in the case of a dispute arising out of the Research Committee, [*] shall have [*] and, in the case of a dispute arising out of the Development Committee, [*] shall have [*] on this issue. If, following such consideration the relevant Committee determines that the [*] shall be dropped and an [*] substituted in its place then such [*] shall be substituted for the [*] for the purposes of this Agreement. Neither Party shall unreasonably withhold or delay its consent to any [*] proposed by a Party pursuant to this Article. Each Party shall, if requested to do so, provide written reasons to the relevant Committee supporting its choice of an [*], or its rejection of the same.

Sharing of Information.

Without prejudice to its other obligations, each Party shall disclose to the other Party all Information Controlled by it and which it reasonably considers to be [*] to any Antibody Product as soon as practicable after it is [*] or its [*] is [*]. The Parties shall [*] in the data dossiers used to support applications for Regulatory Approvals and in the database referred to in Article 3.2.2(a)(viii).

In addition to being informed of the progress of the Research and Development via the Joint Research Committee (pursuant to Article 3.7.1) and the Joint Development Committee (pursuant to Article 3.7.2), each Party shall have the right to obtain through the Joint Research Committee or Joint Development Committee (as appropriate), copies of final reports and a reasonable number of interim reports (in existence) of any studies carried out pursuant to Research and Development conducted under this Agreement and the Joint Research Committee and Joint Development Committee shall have no right to refuse any such request. If, after receiving any such report (or in the event no such report exists), a Party reasonably requires additional Information generated during Research and Development by either Party from pre-clinical studies and clinical trials of each Antibody Product, to exercise its rights or fulfil its obligations under this Agreement the other Party shall in response to a request, use Commercially Reasonable Efforts to provide such

additional Information but only to the extent such additional Information is Controlled by it. The Party requesting such Information shall, if the Information provided by the other Party is incomplete, have the right to access such Information during regular business hours and on reasonable notice.

Each Party shall provide reasonable assistance to the other Party in understanding the data dossiers, database and reports referred to in this Article 3.3, provided that such Party shall use such data, dossiers, databases and reports only for the purpose of exercising its rights or fulfilling its obligations under this Agreement.

Notwithstanding the obligations in this Agreement to provide Information, co-operation and assistance, [*] shall not be obliged to provide to [*] any of the same in relation to the [*] Patent Rights or any invention claimed by any of the [*] Patent Rights or any [*] Technology specific to any such inventions, except in compliance with its obligations under Article 6.7.

Celltech Opt-Out Right.

Celltech shall have the option (the “ opt out right ”) to terminate this Agreement with respect to any Antibody Product which proceeds to Late Stage Development (as well as all other Antibody Products (“ Subsequent Products ”) excluding any Antibody Product which has previously been subject to the procedure under this Article 3.4 and for which Celltech shall have previously elected in accordance with this Article 3.4 to remain subject to the terms of this Agreement), as set out in this Article 3.4. Celltech may exercise such opt-out right by providing written notice to Amgen at any time within [*] of Celltech’s receipt from Amgen of (i) a detailed report of the results of the Phase II Studies of such Antibody Product; (ii) Amgen’s proposed plan for Late Stage Development (“ Late Stage Development Plan ”) for such Antibody Product together with Amgen’s confirmation of its intention to proceed with such plan if Celltech were not to exercise its opt-out right; (iii) Amgen’s good-faith estimate of the Research and Development Costs

of such Late Stage Development Plan and (iv) if the [*] has been dropped in accordance with Article 3.2.2(e) the Late Stage Development Plan will identify any intention Amgen has to develop the [*]. For the avoidance of doubt, with respect to any such intention set forth in such Late Stage Development Plan, other than as set forth in a revised Late Stage Development Plan provided pursuant to Article 3.4(b) below, Amgen shall not be obliged to inform Celltech of any change to Amgen’s intention after providing such Late Stage Development Plan pursuant to this Article 3.4(a). The report, plan and estimate provided to Celltech pursuant to this Article shall be the same standard, quality and completeness as those utilised by Amgen in its internal deliberations and decision making concerning whether to proceed with Development of such Antibody Product.

If at any stage during the conduct of activities pursuant to a Late Stage Development Plan, but prior to obtaining the first Regulatory Approvals to Commercialise such Antibody Product in the Amgen Territory,

the Joint Development Committee has decided (in accordance with the terms of this Agreement) to drop the indication set out in the Late Stage Development Plan and has selected a new indication (subject to Article 3.2.2(e) where the initial indication is the [*]); and

Amgen decides to advance such Antibody Product into Late Stage Development for such new indication; and

the cost of Late Stage Development of such Antibody Product is expected to exceed the good-faith estimate of Research and Development Costs received by Celltech pursuant to Article 3.4(a) by [*] ([*]%) or more; then

a detailed report of the results of the studies undertaken in Late Stage Development completed at the time of such notice together with preliminary results of any other such studies that are still in progress and for which interim or final results are available;

Amgen’s proposed revised Late Stage Development Plan for such Antibody Product;

Amgen’s good faith estimate of the Research and Development Costs of such revised Late Stage Development Plan; and

the revised Late Stage Development Plan will identify any intention Amgen has to develop the [*] (For the avoidance of doubt, with respect to any such intention set forth in such revised Late Stage Development Plan Amgen shall not be obliged to inform Celltech of any change to Amgen’s intention after providing such revised Late Stage Development Plan pursuant to this Article 3.4(b)).

At the date Celltech provides its written notice to Amgen that it is exercising its opt-out right pursuant to Articles 3.4(a) or 3.4(b), as appropriate, Celltech shall provide Amgen with a document signed by an authorized officer of Celltech on its behalf either indicating in such document that (i) the written representations and warranties of Celltech set out in Articles 16.1, 16.2 and 16.3 are true and correct as if made as of the date of such document and as if referring to the Licence Agreement and not this Agreement or (ii) such written representations and warranties of Celltech are not true and correct and the reasons why such

representations and warranties are not true and correct; provided that failure to provide Information that is subject to a Third Party confidentiality obligation shall not make the representation and warranty under Article 16.2(c) or 16.3(c) untrue or incorrect.

Within [*] after receipt of Celltech’s written notice to Amgen under Article 3.4(c), Amgen shall provide Celltech with a document signed by an authorized officer of Amgen on its behalf either indicating in such document that (i) the written representations and warranties of Amgen set out in Articles 16.1 and 16.2 are true and correct as if made as of the date of such document and as if referring to the Licence Agreement and not this Agreement or (ii) such written representations and warranties of Amgen are not true and correct and the reasons why such representation and warranties are not true and correct; provided that failure to provide Information that is subject to a Third Party confidentiality obligation shall not make the representation and warranty under Article 16.2(c) untrue or incorrect.

If Celltech shall not have exercised its opt-out right under Articles 3.4(a) or 3.4(b) with respect to an Antibody Product, this Agreement shall remain in full force and effect with respect to all Antibody Products. However, Celltech’s opt out right shall apply to any other Antibody Product that Amgen proposes to advance or advances to Late Stage Development, and Articles 3.4(a) and (b) shall apply mutatis mutandis to all such Antibody Products.

In the event Celltech shall exercise its opt-out right pursuant to Article 3.4(a) or (b) for any Antibody Product, the Licence Agreement shall immediately come into full force and effect for such Antibody Product (as well as all Subsequent Products). This Agreement shall terminate in relation to such Antibody Product (as well as all Subsequent Products), but remain in full force and effect with respect to any Antibody Product which has previously been subject to the procedures set out in Article 3.4(a) and which Celltech shall not have previously exercised its opt-out right. If Celltech exercises its opt-out right, Celltech shall have no liability for any Research and Development Costs of Late Stage Development, whether or not incurred prior to expiry of the opt-out period.

Budgets.   The budgets for each Contract Year during Research and Development shall be specified by each Party and submitted to the other Party (via the Joint Research Committee or Joint Development Committee, respectively) in a format to be agreed by the Parties but which must include line item estimates of Research and Development Costs by function. The budgets shall be updated by the Joint Research Committee or Joint Development Committee (as appropriate) at least once annually on a timeline that meets the budget planning requirements of both Parties, but in no event less than [*] before the end of the preceding Contract Year; provided however , it is acknowledged and agreed that such budgets may need to be modified from time-to-time between annual updates, based upon the results of clinical studies and other unanticipated events. In any Contract Year, each Party shall promptly inform the other Party upon such Party determining that it is likely to exceed or underspend by more than [*] ([*]%) its respective total budget in that Contract Year. In addition, if in any Contract Year a Party exceeds its budget by more than [*]%, the Party who has so exceeded its budget shall, at the request of the other Party, provide to the Joint Research Committee or Joint Development Committee (as appropriate) and to the Collaboration Committee (if the matter is escalated to the Collaboration Committee) a full explanation for exceeding its budget (as requested). Each Committee may, [*], reduce the amount of any overspend to be included in the Research and Development Costs as it considers equitable in the circumstances. If either the Joint Research Committee or Joint Development Committee do not [*] on how to deal with such overspend, the matter shall be escalated to the Collaboration Committee for consideration. The members of any such Committee (as appropriate) may elect to reduce or not reduce such overspend [*], and unless the relevant Committee [*] to reduce the overspend, [*].

Costs. Amgen and Celltech shall share all costs for the Research and Development of Antibody Products on the following basis:

Research Costs

Early Stage Development Costs

up to [*] Dollars ($[*]) of such cumulative Research and Development Costs, on the basis of [*]:[*] Amgen:Celltech;

over [*] Dollars ($[*]) of such cumulative Research and Development Costs on the basis of [*]:[*] Amgen:Celltech.

Late Stage Development Costs

up to [*] Dollars ($[*]) of such cumulative Research and Development Costs, on the basis of [*]:[*] Amgen:Celltech; and

over [*] Dollars ($[*]) of such cumulative Research and Development Costs, on the basis of [*]:[*] Amgen:Celltech.

Quarterly Reconciliation of Research and Development Costs

At least [*] prior to the end of each Calendar Quarter, each Party shall submit to the other Party: (i) a report of the actual Research and Development Costs incurred by such Party in the first [*] of such quarter; and (ii) an estimate of Research and Development Costs to be incurred in the [*] of such quarter.

Within [*] following the end of each Calendar Quarter, Amgen shall submit to Celltech a written report setting forth in reasonable detail (to the extent made or incurred by Amgen) its Research and Development Costs for such quarter showing, on a line item basis, variances from the budget for that quarter, together with an estimate of Research and Development Costs for the remainder of that Contract Year.

Within [*] following the end of each Calendar Quarter, Celltech shall submit to Amgen a written report setting forth in reasonable detail (to the extent made or incurred by Celltech) its Research and Development Costs for such quarter

showing, on a line item basis, variances from the budget for that quarter, together with an estimate of Research and Development Costs for the remainder of that Contract Year.

Within [*] following the end of each Calendar Quarter, Amgen shall submit to Celltech a written consolidated report setting forth in reasonable detail the calculation of all Research and Development Costs and the calculation of any net amount owed by Celltech to Amgen or by Amgen to Celltech, as the case may be, in order to ensure the appropriate sharing of Research and Development Costs in accordance with the provisions of Article 3.6.1 or 3.6.2 or 3.6.3 as appropriate. The net amount payable shall be paid by Amgen or Celltech, as the case may be, within [*] after receipt of such written report. If the invoiced amount exceeds the initial budget forecast for such quarter (as provided in Article 3.5) by more than [*] ([*]%), the paying Party may elect to carry the difference between the budgeted amount and the invoiced amount over to the next Calendar Quarter. The election to carry the difference over must be provided within [*] after the date such above-referenced written report is provided by Amgen to Celltech. If, as a result of carrying over such difference to a subsequent quarter, the total amount payable in that subsequent quarter exceeds the initial budget forecast for that quarter by more than [*] ([*]%), the difference between the budgeted amount and the invoiced amount (including the carryover from the previous quarter) may be carried over to the next quarter. Such carry over may be continued quarter-by-quarter to the end of the Contract Year when it shall be paid in full within ten (10) Business Days of the receipt of the above-referenced report by Celltech from Amgen at the end of the Contract Year.

Pre-Launch Commercialisation Cost .  Each Party shall provide the Joint Development Committee with a good faith preliminary estimate of its pre-launch Commercialisation Costs of an Antibody Product on or about the date Amgen provides written notice to Celltech that it intends to proceed with Late Stage Development activities with respect to such Antibody Product.

Governance of Research and Development.

Research

Promptly after the Effective Date the Parties shall form a Joint Research Committee to co-ordinate the Research activities of the Parties. The Joint Research Committee shall consist of equal numbers (not more than three) from each Party. Either Party may (with the consent of the other Party not to be unreasonably withheld or delayed) invite additional participants from either Party to provide expert opinions for some or all of the meetings.

Meetings of the Joint Research Committee shall be held at least every three (3) months and shall be held more frequently if reasonably requested by either Party. Meetings which are held in person shall be held alternately at Amgen and Celltech locations (with the first meeting to be held at a Celltech location). Meetings may take place by videoconference or similar means if agreed by both Parties. Promptly following the Effective Date the Joint Research Committee shall hold an organisational meeting to establish its operational requirements. At each scheduled Joint Research Committee meeting each Party shall present a detailed report showing any progress on its Research activities since the previous scheduled meeting of the Committee.

The Joint Research Committee generally shall have the responsibility of managing, directing and overseeing Research including the following responsibilities:

modifying the Research Plan, as appropriate;

co-ordinating the Research activities of both Parties in accordance with the Research Plan, so as to identify Antibody Products suitable for Development;

agreeing Antibody Product candidates (including whether to select a [*] Antibody and/or [*] Antibody) for filing of an IND; and

agreeing key decisions required in order to progress the Research and the appropriate criteria to be met in reaching such decisions.

[*] shall appoint from amongst its representatives a chairperson of the Joint Research Committee with the responsibility to arrange meetings in accordance with this Agreement and to prepare and distribute the minutes of all key decisions made by the Joint Research Committee. Such minutes shall be distributed by the chairperson within ten (10) Business Days of each Joint Research Committee meeting. Minutes shall be approved or disapproved and revised if necessary at the next meeting.

A primary objective of the Joint Research Committee is to reach unanimous decisions, with the representatives of each Party who are members of the Joint Research Committee collectively having one (1) vote, arrived at through open discussions amongst the representatives of each of the Parties. In the event of a tied vote, the [*] shall, after giving due consideration to the views expressed by both Parties, have [*] in all matters, except the following (“ Excepted Matters ”):

changes in the direction of Research and Development from the [*] to an [*] as the initial indication for which to file an IND;

[*]. [*] will not, having regard to the potential impact of any proposed change on [*], unreasonably withhold or delay its consent to any reasonable change proposed by [*];

changes in the Research Plan that represent a major change in the scope or direction of the Research Plan. [*] will not, having regard to the potential impact of any proposed change on [*], unreasonably withhold or delay its consent to any reasonable change proposed by [*]; or

any changes to the then-approved [*] as set out in [*].

Development

Upon the decision of the Joint Research Committee to file the first IND application for an Antibody Product, the Parties shall form a Joint Development Committee. The Joint Development Committee shall consist of equal numbers (not more than three) from each Party. Either Party may (with the consent of the other Party, not to be unreasonably withheld or delayed) invite additional participants from either Party to provide expert opinions for some or all of the meetings. Meetings of the Joint Development Committee shall be held at least every six (6) months and shall be held more frequently if reasonably requested by either Party. If agreed between the Parties at any time, the Joint Development Committee may assume any residual responsibilities of the Joint Research Committee, and the latter may then be disbanded.

Meetings of the Joint Development Committee which are held in person shall be held alternately at Amgen and Celltech locations (with the first meeting to be held at an Amgen location). Meetings may take place by videoconference or similar means if agreed by both Parties. At each scheduled Joint Development Committee meeting each Party shall present a detailed report showing any progress on its Development activities since the previous scheduled meeting of the Committee.

The responsibilities of the Joint Development Committee shall be to (i) co-ordinate the Development activities of both Parties; (ii) share information about Development activities and the results thereof; and (iii) establish procedures for the collection, sharing and reporting of adverse event information pursuant to Article 4.6 and relating to the Antibody Products obtained after Regulatory Approval thereof.

[*] shall appoint from amongst its representatives a chairperson of the Joint Development Committee with the responsibility to arrange meetings in accordance with this Agreement and to prepare and distribute the minutes of all key decisions made by the Joint Development Committee. Such minutes shall be distributed by the chairperson within fifteen (15) Business Days of each Joint Development Committee meeting. Minutes shall be approved or disapproved and revised if necessary at the next meeting.

A primary objective of the Joint Development Committee is to reach unanimous decisions, with the representatives of each Party who are members of the Joint Development Committee collectively having one (1) vote, arrived at through open discussions amongst the representatives of each of the Parties. In the event of a tied vote, [*] shall, after giving due consideration to the views expressed by both Parties, have [*] in all matters provided that to the extent the matter concerns a Research activity [*] shall not have [*] in respect of the Excepted Matters set out in Article 3.7.1(e).

 Rights and Responsibilities through [*].

The Parties shall fully consult and co-operate with each other on all matters relating to and in communications with Regulatory Authorities and shall use Commercially Reasonable Efforts to obtain Regulatory Approval for Commercialisation of each Antibody Product and indication in [*] at the earliest possible opportunity. In particular, until Celltech assumes exclusive control for regulatory matters in any country in the Celltech Territory the Parties will co-ordinate all communications with Regulatory Authorities in countries in the

Celltech Territory to ensure consistent and clear communication with the Regulatory Authorities in those countries. In addition, each Party will discuss in advance with the other Party any planned communication with any Regulatory Authority in the Celltech Territory, where such communication may affect the activities of the other Party.

When designing and implementing [*] studies Amgen will consult with Celltech and accommodate the requirements of the Celltech Territory within Amgen’s [*] studies, to the extent that is practicable. To the extent any such requirements are not accommodated within such Amgen studies, Celltech may conduct such studies as supplemental [*] studies in accordance with Article 3.2.2(b).

Subject to Article 4.1(a) and (b), in each jurisdiction Amgen shall be primarily responsible for all regulatory matters (including communications with Regulatory Authorities) concerning each Antibody Product and each indication with such Antibody Product up to delivery to Celltech of the filed data package in accordance with Article 4.1(d). Notwithstanding the previous sentence, during Development prior to completion of a said data package Celltech shall have the right to communicate with Regulatory Authorities in the Celltech Territory solely for the purposes of Article 4.1(c) (i)-(iv) below:

determining appropriate filing strategies for Drug Approval Applications within the Celltech Territory and matters concerning such Drug Approval Applications;

planning, designing and conducting supplemental [*] activities as permitted by Article 3.2.2(b)

planning, designing and conducting Marketing Clinical Studies; and

with respect to process Development, manufacture and supply of Antibody Raw Material, unless Amgen is the only Manufacturing Lead.

Amgen shall provide Celltech with a copy of and reasonable opportunity to comment on the data package suitable for a Drug Approval Application for each Antibody Product in each indication intended to be submitted by Amgen to the FDA. Amgen shall provide Celltech with a copy of such data package when filed and with any subsequent data packages filed in such indication.

Rights and Responsibilities of Territorial Commercial Leads.   On an indication-by-indication basis, as reasonably required, each Territorial Commercial Lead shall have the right to monitor, review and direct all aspects of all regulatory matters to the extent the same concern the activities and studies for which it is responsible pursuant to Article 4.1 with respect to each such Antibody Product, including making all strategic and tactical decisions with respect thereto. Each Territorial Commercial Lead shall have the right and responsibility for the filing of a Drug Approval Application in its own name, including the conformation of the data package provided by Amgen to the requirements of each jurisdiction within its Lead Territory and for seeking Regulatory Approvals for such Antibody Products in its Lead Territory. Notwithstanding the above, pursuant to Article 4.1, Amgen shall remain responsible for all regulatory matters for all Antibody Products for any indication which is not yet the subject of [*].

Additional Rights and Responsibilities of Manufacturing Lead.   The Manufacturing Lead in the case of Antibody Raw Material and Amgen in the case of Antibody Products in Finished Form (as appropriate) shall be responsible for obtaining all necessary Regulatory Approvals to enable it to supply the same as specified in Article 6.

Co-operation.   Notwithstanding anything to the contrary in this Agreement, each Party shall have the right to receive from the other Party, and each Party shall provide to the other Party, all regulatory data or information which Amgen or the Territorial Commercial Lead is required to submit to a Regulatory Authority (as it is required by law, rule, regulation or a Regulatory Authority having jurisdiction in any part of the Territory to have access) in sufficient time to comment on and consult with each other with respect to the same.

Access to INDs.   At the request of Celltech and for the purposes set out in Article 4.1(c), Amgen shall grant Celltech a right of access and reference to (and name it a party of record on) all INDs in such country in the Celltech Territory and shall promptly notify Regulatory Authorities in such country of (and as soon as is reasonably practicable thereafter take all actions reasonably necessary to effect or evidence) the right of access and reference to (and naming Celltech as a party of record on) such INDs.

Adverse Event Reporting; Customer Complaints.

Each Party shall maintain a record of all non-medical and medical product-related complaints and reports of adverse events that it receives with respect to any Antibody Product. Each Party shall notify the other Party of any complaint received by it and, within three (3) days of the initial receipt, shall provide the other Party with a copy of such complaint(s) and adverse event reports. Amgen shall maintain such adverse reaction information in the database described in Article 3.2.2(a).

Except as set forth in Article 4.6(c) below, each Party shall be responsible for reporting to Regulatory Authorities any adverse experience and safety issues for such Antibody Product arising out of its activities and studies, in compliance with the requirements of the laws, rules and regulations in its Territory, and shall promptly thereafter provide the other Party with a copy of such report. If possible, with respect to the Celltech Territory, the other Party shall have an opportunity to review and the Parties shall consult with each other, prior to submission of any such report.

Following the delivery of the filed data package for an Antibody Product to Celltech pursuant to Article 4.1(d), each Territorial Commercial Lead shall be responsible for reporting to Regulatory Authorities, in each country within its Lead Territory, any adverse experience and safety issues for such Antibody Product in the relevant jurisdiction in compliance with the requirements of all applicable laws and regulations in such country and shall promptly thereafter

provide the other Party with a copy of such report. Notwithstanding anything to the contrary in this Agreement, the Territorial Commercial Lead shall have the right to receive from the other Party (and the other Party shall provide to the Territorial Commercial Lead) any regulatory data or information Controlled by the other Party which the Territorial Commercial Lead, as the holder of any Drug Approval Application or Regulatory Approval in its Lead Territory, requires by law, rule, regulation or a Regulatory Authority having jurisdiction in its Lead Territory to have access, or which the Territorial Commercial Lead reasonably requires in order to carry out its responsibilities pursuant to this Agreement.

Communications.

In addition to the responsibilities in Article 4.6(c), each Party shall have primary responsibility for all correspondence and for any official communications with Regulatory Authorities in the Territory in respect of the activities and studies for which it is responsible. Each Party shall reasonably co-operate with the other Party regarding any direct communications with the Regulatory Authorities.

Both Parties shall have the right to [*] with Regulatory Authorities having jurisdiction in any part of the Celltech Territory where any matter which may affect the activities or studies of the other Party is to be discussed.

Without prejudice to the other provisions of this Article 4, following delivery of the filed data package to Celltech pursuant to Article 4.1(d), the Territorial Commercial Lead for such country shall have exclusive responsibility for all correspondence in respect of the Antibody Product covered by such data package and for any official communications with Regulatory Authorities in such country regarding its rights and responsibilities under this Article 4 (including submitting Regulatory Filings, seeking Regulatory Approvals, filing annual reports, and filing of Promotional Materials) consistent with all applicable laws and regulations of any such country. Except as may be required by applicable laws and regulations, or requested by the Territorial Commercial Lead or any

Regulatory Authority having jurisdiction in such country, the other Party shall not communicate regarding any Antibody Product with any Regulatory Authority having jurisdiction in such country. The other Party shall keep the Territorial Commercial Lead informed of any such required communications.

Regarding the manufacture of any Antibody Raw Material and/or Antibody Product, both Parties shall have the right to [*] with Regulatory Authorities having jurisdiction in the Territory wherein issues regarding the manufacturing of such Antibody Raw Material and/or Antibody Product in Finished Form contained in any Regulatory Filings is to be discussed, where the Party responsible for communications is different from the Party responsible for said manufacturing issues or where required by law or regulation. Notwithstanding the above, and unless Amgen is the Manufacturing Lead, Celltech shall have exclusive responsibility for all correspondence and for any official communications with Regulatory Authorities in the Territory in connection with the supply of Antibody Raw Material and as reasonably required to meet its obligations with respect to any such supply under this Agreement. The Manufacturing Lead with respect to Antibody Raw Material, and Amgen with respect to Antibody Product in Finished Form, shall have the right, to the extent permitted by Regulatory Authorities, to file a drug master file with a Regulatory Authority to make their respective proprietary manufacturing information (e.g., the CMC section contained in any Regulatory Filings) and formulation information available directly to the Regulatory Authority, in order to help preserve the proprietary nature thereof; provided however , that the other Party shall have the right of access and reference to the extent required, as a result of its responsibilities hereunder, by law, rule, regulation or a Regulatory Authority having jurisdiction in the Territory.

Each Party shall promptly notify and provide the other Party with a copy of any correspondence or other reports or complaints submitted to or received by the first Party from any Regulatory Authority or other Third Party claiming that any Promotional Materials are inconsistent with the Product Labelling or are otherwise in violation of any applicable laws and regulations of any country in the Territory.

Recalls.

The Parties shall exchange their internal standard operating procedures as to product recalls (“ SOPs ”) reasonably promptly after the first filing of a Drug Approval Application for an Antibody Product and reasonably promptly after such SOPs are approved or modified thereafter. In the event that, in a country, the Territorial Commercial Lead for such country determines that an event, incident or circumstance has occurred which may result in the need for a “recall” or “market withdrawal” or “stock recovery” (as such terms are defined in U.S. regulations in 21 CFR 7.3 or another similar national, state or local law or regulation), hereinafter collectively referred to as a “ Recall ”, of Antibody Product or any lot(s) thereof, such Party shall promptly notify the other Party in writing.

The Territorial Commercial Lead shall have the right to determine whether and upon what terms and conditions to Recall the Antibody Product within its Lead Territory; provided however , if the Territorial Commercial Lead shall elect not to conduct a Recall of the Antibody Product, and solely if the other Party is responsible for the manufacture of Antibody Raw Material or Antibody Product in Finished Form, and the manufacture of Antibody Raw Material or Antibody Product in Finished Form is the basis of such proposed Recall, the other Party shall have the right to conduct such Recall if, in its good faith opinion, regulatory requirements or public safety considerations so require. Prior to making any Recall decision in any part of its Territory, each Party shall consult with the other Party. The Territorial Commercial Lead shall be responsible for discussions with Regulatory Authorities within the applicable country regarding all aspects of the Recall decision and the execution thereof. Any costs or expenses of any Recall in any part of the Territory shall be a Commercialisation Expense. Celltech and Amgen shall each maintain complete and accurate records of any Recall it has the right to control pursuant to this Article 4.8 for such periods as may be required by legal requirements, but in any event for no less than [*].

Applications for Regulatory Exclusivity.   The Parties recognise that exclusivity rights granted or provided for under regulatory laws of the countries of the Territory may be commercially significant to Antibody Products. To the extent permitted by law, as between the Parties, the Territorial Commercial Lead for a country shall have the exclusive right to file for, request and maintain any regulatory exclusivity rights for Antibody Products in such country (including regulatory exclusivity rights based upon an orphan drug designation of an Antibody Product) and to conduct and prosecute any proceedings or actions to enforce such regulatory exclusivity rights.